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+generic id,generic name,slug,monograph link,drug class,indication,indication description,therapeutic class description,pharmacology description,dosage description,administration description,interaction description,contraindications description,side effects description,pregnancy and lactation description,precautions description,pediatric usage description,overdose effects description,duration of treatment description,reconstitution description,storage conditions description,descriptions count
+31,Adalimumab,adalimumab-31,https://medex.com.bd/attachments/FgGWUFrlD7LThDOJE9ArMGq3BaZ3J3/adalimumab-prescribing-information,Immunosuppressant,Ulcerative colitis,"
Adalimumab is a tumor necrosis factor (TNF) blocker indicated for treatment of:
+
+- Rheumatoid Arthritis (RA): Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA
... Read more
Adalimumab is a tumor necrosis factor (TNF) blocker indicated for treatment of:
+
+- Rheumatoid Arthritis (RA): Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA
+- Juvenile Idiopathic Arthritis (JIA): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older
+- Psoriatic Arthritis (PsA): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA
+- Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS
+- Adult Crohn’s Disease (CD): Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab
+- Pediatric Crohn’s Disease: Reducing signs and symptoms and inducing and maintaining clinical remission in patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate
+- Ulcerative Colitis (UC): Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of Adalimumab has not been established in patients who have lost response to or were intolerant to TNF blockers
+- Plaque Psoriasis (Ps): The treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate
+- Hidradenitis Suppurative (HS): The treatment of moderate to severe hidradenitis suppurativa
+
","Disease-modifying antirheumatic drugs (DMARDs), Immunosuppressant
","Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). Adalimumab binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also lyses surface TNF expressing cells in vitro in the presence of complement. TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF are found in the synovial fluid of patients with Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases. Increased levels of TNF are also found in psoriasis plaques. In Plaque Psoriasis, treatment with Adalimumab may reduce the epidermal thickness and infiltration of inflammatory cells.
","Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis: 40 mg every other week Some patients with RA not receiving methotrexate may benefit from increasing the frequency to 40 mg every week.
Juvenile Idiopathic Arthritis:
+
+- 10 kg to <15 kg: 10 mg every other week
+- 15 kg to < 30 kg: 20 mg every other week
+- ≥ 30 kg: 40 mg every other week
+
+Adult Crohn's Disease and Ulcerative Colitis:
+
+- Initial dose (Day 1): 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days).
+- Second dose two weeks later (Day 15): 80 mg.
+- Two weeks later (Day 29): Maintenance dose of 40 mg every other week.
+- For patients with Ulcerative Colitis only: Adalimumab should only be continued in patients who have shown evidence of clinical remission by eight weeks (Day 57) of therapy.
+
+Pediatric Crohn’s Disease:
+
+- 17 kg to < 40 kg: Initial dose (Day 1): 80 mg (two 40 mg injections in one day) , Second dose two weeks later (Day 15): 40 mg , Two weeks later (Day 29): Maintenance dose of 20 mg every other week.
+- ≥ 40 kg: Initial dose (Day 1): 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) , Second dose two weeks later (Day 15): 80 mg (two 40 mg injections in one day) , Two weeks later (Day 29): Maintenance dose of 40 mg every other week.
+
+Plaque Psoriasis:
+
+- 80 mg initial dose, followed by 40 mg every other week starting one week after initial dose.
+- Hidradenitis Suppurativa: Initial dose (Day 1): 160 mg (given as four 40 mg injection on Day 1 or as two 40 mg injections per day on Days 1 and 2, Second dose two weeks later (Day 15): 80 mg (two 40 mg injections in one day), Third (Day 29) and subsequent doses: 40 mg every week.
+
","Administered by subcutaneous injection.
","Abatacept: Increased risk of serious infection
Anakinra: Increased risk of serious infection
Live vaccines: Adalimumab use should be avoided
","Adalimumab should not be administered to patients with known hypersensitivity to Adalimumab or any of its components.
","The most common adverse reaction with Adalimumab was injection site reactions (erythema and/or itching, hemorrhage, pain or swelling). The most common adverse reactions leading to discontinuation of Adalimumab in rheumatoid arthritis were clinical flare reaction, rash and pneumonia.
+
+- Other adverse reactions of Adalimumab includes- Gastrointestinal disorders: Diverticulitis, large bowel perforations including perforations associated with diverticulitis and appendiceal perforations associated with appendicitis, pancreatitis.
+- General disorders and administration site conditions: Pyrexia.
+- Hepato-biliary disorders: Liver failure, hepatitis.
+- Immune system disorders: Sarcoidosis.
+- Neoplasms benign, malignant and unspecified (including cysts and polyps): Merkel Cell Carcinoma (neuroendocrine carcinoma of the skin).
+- Nervous system disorders: Demyelinating disorders (e.g., optic neuritis, Guillain-Barré syndrome).
+- Cerebrovascular accident Respiratory disorders: Interstitial lung disease, including pulmonary fibrosis.
+- Pulmonary embolism Skin reactions: Stevens Johnson Syndrome, cutaneous vasculitis, erythema multiforme, new or worsening psoriasis (all sub-types including pustular and palmoplantar), alopecia.
+- Vascular disorders: Systemic vasculitis, deep vein thrombosis.
+
","Pregnancy Category B. Adequate and well controlled studies with Adalimumab have not been conducted in pregnant women. Adalimumab is an IgG1 monoclonal antibody and IgG1 is actively transferred across the placenta during the third trimester of pregnancy. Limited data from published literature indicate that Adalimumab is present in low levels in human milk and is not likely to be absorbed by a breastfed infant. However, no data is available on the absorption of Adalimumab from breast milk in newborn or preterm infants. Caution should be exercised when Adalimumab is administered to a nursing woman.
","
+- Serious infections: Adalimumab should not be started during an active infection. If an infection develops, should be carefully monitored and if infection becomes serious Adalimumab should be stopped.
+- Invasive fungal infections: For patients who develop a systemic illness on Adalimumab, empiric antifungal therapy should be considered for those who reside or travel to regions where mycoses are endemic
+- Malignancies: Incidence of malignancies was greater in Adalimumab-treated patients than in controls
+- Anaphylaxis or serious allergic reactions may occur Hepatitis B virus reactivation: HBV carriers should be monitored during and several months after therapy. If reactivation occurs, Adalimumab should be stopped and antiviral therapy should be started
+- Demyelinating disease: Exacerbation or new onset, may occur Cytopenias, pancytopenia: Patients should be advised to seek immediate medical attention if symptoms develop, and should be considered stopping Adalimumab
+- Heart failure: Worsening or new onset, may occur
+- Lupus-like syndrome: Adalimumab should be stopped if syndrome develops
+
","Pediatric Use: Safety and efficacy of Adalimumab in pediatric patients for uses other than polyarticular juvenile idiopathic arthritis (JIA) and pediatric Crohn’s disease have not been established.
Geriatric Use: A total of 519 patients 65 years of age and older, including 107 patients 75 years and older, received Adalimumab in clinical studies. No overall difference in effectiveness was observed between these subjects and younger subjects. The frequency of serious infection and malignancy among Adalimumab treated subjects over age 65 was higher than for those under age 65. Because there is a higher incidence of infections and malignancies in the elderly population in general, caution should be used when treating the elderly.
","The maximum tolerated dose of Adalimumab has not been established in humans. Multiple doses up to 10 mg/kg have been administered to patients in clinical trials without evidence of dose-limiting toxicities. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
",,,"Do not use beyond the expiration date on the container. Adalimumab must be refrigerated at 2-8° C. Do not freeze. Protect the pre-filled syringe from exposure to light. Store in original carton until time of administration.
",13
+10,Acyclovir + Hydrocortisone,acyclovir-hydrocortisone-10,https://medex.com.bd/attachments/hmi4dt8aYaBubgZ8AkKxlsmFQ49ppe/acyclovir-hydrocortisone-prescribing-information,Hydrocortisone & Combined preparations,Herpes labialis,"Acyclovir & Hydrocortisone Cream is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and children (6 years of age and older).
","Hydrocortisone & Combined preparations
","Acyclovir is a synthetic purine nucleoside analogue with inhibitory activity against Herpes simplex viruses type 1 (HSV-1) and type 2 (HSV-2) in cell culture and in vivo. The inhibitory activity of Acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV. This viral enzyme converts Acyclovir into Acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In cell culture, Acyclovir Triphosphate stops replication of herpes viral DNA. This inhibition is accomplished in 3 ways:
+
+- Competitive inhibition of viral DNA polymerase
+- Incorporation into and termination of the growing viral DNA chain
+- Inactivation of the viral DNA polymerase
+
+Hydrocortisone is the main glucocorticoid secreted by the adrenal cortex. It is used topically for its anti-inflammatory effects which suppress the clinical manifestations of the disease in a wide range of disorders where inflammation is a prominent feature.
","The cream should be topically applied 5 times per day for 5 days. Therapy should be initiated as early as possible after the first signs and symptoms.
",,,"There is no known contraindication.
","The following most common adverse reactions (<1%) were local skin reactions like drying or flaking of the skin; burning or tingling, erythema; pigmentation changes, application site reactions including signs and symptoms of inflammation.
","Pregnancy Category B. There are no adequate and well-controlled studies of systemic Acyclovir in pregnant women. No studies have been performed in pregnant women. Systemic exposure of Acyclovir and Hydrocortisone following topical administration of this cream is minimal. It is not known whether topically applied Acyclovir or Hydrocortisone is excreted in breast milk. Because many drugs are excreted in human milk, caution should be exercised when administered to a nursing woman.
","Acyclovir and Hydrocortisone should not be used in the eye, inside the mouth or nose, or on the genitals. Patients should seek medical advice when a cold sore fails to heal within 2 weeks.
","Safety and effectiveness in pediatric subjects less than 6 years of age have not been established.
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+9,Acyclovir (Topical),acyclovir-topical-9,https://medex.com.bd/attachments/ENyoYKzQq8b7VMZE4lELf5n7tqUYGm/acyclovir-topical-prescribing-information,Topical Antiviral preparations,Sore lips,"Acyclovir cream is a herpes simplex virus (HSV) nucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older.
","Topical Antiviral preparations
","Acyclovir is an antiviral drug active against herpes simplex virus. Acyclovir is a synthetic purine nucleoside analogue with cell culture and in vivo inhibitory activity against HSV types 1 (HSV-1) and 2 (HSV-2). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In cell culture, acyclovir triphosphate stops replication of herpes viral DNA. This inhibition is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase.
","Acyclovir cream should be applied five times per day for four days. Therapy should be initiated as early as possible following the onset of signs or symptoms of herpes labialis i.e., during the prodrome or when lesions appear. For adolescents 12 years of age and older, the dosage is the same as in adults.
",,"Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with Acyclovir cream. Due to minimal systemic absorption of Acyclovir cream, systemic drug interactions are unlikely.
","Acyclovir cream is contraindicated in patients with known hypersensitivity to acyclovir, valacyclovir, or any component of the formulation.
","The most common adverse reactions at the site of topical application were dry lips, desquamation, dryness of skin, cracked lips, burning skin, pruritus, flakiness of skin, and stinging on skin; each adverse reaction occurred in less than 1% of patients receiving Acyclovir cream and placebo. Three patients on Acyclovir cream and one patient on placebo discontinued treatment due to an adverse event.
","Pregnancy Category B. There are no adequate and well-controlled studies of acyclovir cream in pregnant women. Acyclovir cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether topically applied acyclovir is excreted in breast milk. Systemic exposure following topical administration is minimal.
","Acyclovir cream should only be applied on the affected external aspects of the lips and face in patients with herpes labialis. Because no data are available, application to human mucous membranes is not recommended. Acyclovir cream is intended for cutaneous use only and should not be used in the eye or inside the mouth or nose. Cream has a potential for irritation and contact. The effect of Acyclovir cream has not been established in immunocompromised patients.
","Pediatric Use: An open-label, uncontrolled trial with Acyclovir cream 5% was conducted in 113 patients aged 12 to 17 years with recurrent herpes labialis. In this trial, therapy was applied using the same dosing regimen as in adults and subjects were followed for adverse events. The safety profile was similar to that observed in adults. Safety and effectiveness in pediatric patients less than 12 years of age have not been established.
Geriatric Use: Clinical studies of acyclovir cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Systemic absorption of acyclovir after topical administration is minimal.
",,,,"Store Acyclovir cream at room temperature between 20°C to 25°C
",11
+12,Acyclovir (Oral),acyclovir-oral-12,https://medex.com.bd/attachments/zVc7h4TgucYev3wdbHFLiqLLdJbnvL/acyclovir-oral-prescribing-information,Herpes simplex & Varicella-zoster virus infections,Varicella zoster (chickenpox),"Aciclovir is indicated for-
+
+- The treatment of viral infections due to Herpes simplex virus (type I & II) and Varicella zoster virus (herpes zoster & chicken pox).
+- The treatment of Herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes and herpes labialis.
+- The prophylaxis of Herpes simplex infections in immunocompromised patients
+
","Herpes simplex & Varicella-zoster virus infections
","Aciclovir is a synthetic purine derivative. Aciclovir exerts its antiviral effect on Herpes simplex virus (HSV) and Varicella-zoster virus by interfering with DNA synthesis and inhibiting viral replication. In cells infected with herpes virus, the antiviral activity of Aciclovir appears to depend principally on the intracellular conversion of the drug to Aciclovir Triphosphate. Aciclovir is converted to Aciclovir Monophosphate principally via virus coded thymidine kinase; the monophosphate is phosphorylated to the diphosphate via cellular guanylate kinase and then via another cellular enzyme to the triphosphate, which is the pharmacologically active form of the drug. 15-30% of an oral dose of the drug is absorbed from Gl tract. Peak plasma concentrations usually occur within 1.5-2 hours after oral administration. It is widely distributed into body tissues and fluids including the brain, saliva, lungs, liver, muscle, spleen, uterus, vaginal mucosa and secretions, CSF, and herpetic vesicular fluid. Aciclovir is excreted through the kidney by the glomerular filtration & tubular secretion.
","Treatment of initial herpes simplex: 200 mg 5 times daily usually for 5 days.
For immunocompromised patients:
+
+- Adult: 400 mg 5 times daily for 5 days (longer if new lesions appear during treatment or if healing is incomplete; increase dose to 800 mg 5 times daily for genital herpes in immunocompromised) or as directed by the registered physician.
+- Children under 2 years: Half of the adult dose.
+- Children over 2 years: Adult dose.
+
+Prevention of recurrence of herpes simplex:
+
+- Adult: 200 mg 4 times daily or 400 mg twice daily possibly reduced to 200 mg 2 or 3 times daily and interrupted every 6-12 months.
+- Children under 2 years: Half of the adult dose.
+- Children over 2 years: Adult dose.
+
+Prophylactic treatment of herpes simplex in the immunocompromised patients:
+
+- Adult: 200 to 400 mg 4 times daily.
+- Children under 2 years: Half of the adult dose.
+- Children over 2 years: Adult dose.
+
+Treatment of vericella (chicken pox):
+
+- Adult and children over 40 kg: 800 mg 4 times daily for 5 days.
+- Children below 40 kg: 20 mg/kg (maximum 800 mg) per dose orally 4 times daily (80 mg/kg/day) for 5 days.
+- Children 1 month-2 years: 200 mg 4 times daily for 5 days.
+- Children 2-5 years:400 mg 4 times daily for 5 days.
+- Children 6-12 years:800 mg 4 times daily for 5 days.
+
+Treatment of herpes zoster (Shingles): 800 mg 5 times daily for 7 days.
Treatment of initial rectal (Proctitis) herpes infections: An oral Aciclovir dosage of 400 mg 5 times daily for 10 days or until clinical resolution occurs has been recommended.
Renal Impairment: For patients with severe renal impairment, a reduction of the doses is recommended.
",,"Probenecid reduces Aciclovir excretion and so increases plasma concentration and risk of toxicity.
","Aciclovir is contraindicated in patients known to be hypersensitive to Aciclovir.
","Rash, gastrointestinal disturbance, rise in bilirubin and liver-related enzymes, increase in blood urea and creatinine, decrease in hematological indices, headache, neurological reaction, fatigue.
","Pregnancy category B. Aciclovir should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Caution should be exercised when it is administered to a nursing mother.
","Aciclovir should be administered with caution in patients with renal impairment and doses should be adjusted according to creatinine clearance. Monitor neutrophil count at least twice weekly in neonates.
",,,,,"Should be stored below 25°C. It should be protected from light and moisture.Keep out of the reach of children.
",10
+13,Acyclovir (Ophthalmic),acyclovir-ophthalmic-13,https://medex.com.bd/attachments/Kz5fDjxpm2VFnag8dQCT5ZhRUDb4oB/acyclovir-ophthalmic-prescribing-information,Ophthalmic Anti-viral Products,Neonatal Conjunctivitis,"Acyclovir is indicated for the treatment of Herpes simplex keratitis.
","Ophthalmic Anti-viral Products
","Acyclovir is an antiviral agent which is highly active in vitro against Herpes simplex (HSV) types I and II and Varicella zoster viruses, but its toxicity to mammalian cells is low. Acyclovir is phosphorylated to the active compound Acyclovir triphosphate after entry into herpes infected cell. The first step in this process requires the presence of the viral-coded thymidine kinase. Acyclovir triphosphate acts as an inhibitor of and substrate for the herpes specified DNA polymerase preventing further viral DNA synthesis without affecting normal cellular processes.
","The dosage for all age groups is the same. A 10 mm ribbon of the ointment should be placed inside the lower conjunctival sac five times a day at approximately four hourly intervals. Treatment should continue for at least 3 days after healing
",,"No clinically significant interactions have been identified.
","Acyclovir is contraindicated in patients known to be hypersensitive to Acyclovir or Valacyclovir
","Very common: Superficial punctate keratopathy. This did not necessitate an early termination of therapy and healed without apparent sequelae. Common: Transient mild stinging of the eye occurring immediately following application, conjunctivitis. Rare: Blepharitis.
","Pregnancy category B. There are no adequate and well-controlled studies of Acyclovir in pregnant women. It is not known whether topically applied Acyclovir is excreted in breast milk.
","The recommended dosage, frequency of applications, and length of treatment should not be exceeded.
",,"No adverse effects would be expected if the entire contents of the tube containing 90 mg Acyclovir were ingested orally.
",,,"Store in a cool and dry place. Keep away from light. Keep out of reach of children. Do not touch the tip of the tube since this may contaminate the product. After one month of the opening do not use the medicine of tube.
",11
+7,Acyclovir (Injection),acyclovir-injection-7,https://medex.com.bd/attachments/PmBd3zpkyItom7JR1PQT4BuZhCyvfR/acyclovir-injection-updated-2017-prescribing-information,Herpes simplex & Varicella-zoster virus infections,Varicella zoster (chickenpox),"Acyclovir intravenous infusion is indicated for the treatment of-
+
+- Acute clinical manifestations of Herpes simplex virus in immunocompromised patients
+- Severe primary or non-primary genital herpes in immune competent patients
+- Varicella zoster virus infection in immunocompromised patients
... Read more
Acyclovir intravenous infusion is indicated for the treatment of-
+
+- Acute clinical manifestations of Herpes simplex virus in immunocompromised patients
+- Severe primary or non-primary genital herpes in immune competent patients
+- Varicella zoster virus infection in immunocompromised patients
+- Herpes zoster (shingles) in immune competent patients who show very severe acute local or systemic manifestations of the disease
+- Herpes simplex encephalitis
+
","Herpes simplex & Varicella-zoster virus infections
","Acyclovir exerts its antiviral eects on Herpes simplex virus and Varicella zoster virus by interfering with DNA synthesis and inhibiting viral replication. In cells infected with Herpes virus, the antiviral activity of Acyclovir appears to depend principally on the intracellular conversion of the drug to Acyclovir Triphosphate. Acyclovir is converted to Acyclovir Monophosphate principally via virus coded thymidine kinase, the monophosphate is phosphorylated to diphosphate via cellular guanylate kinase and then via other cellular enzymes to the Triphosphate, which is the pharmacologically active form of the drug.
","
+- Herpes simplex infection: For normal or immunocompromised immune status: 5 mg/kg every 8 hours
+- Very severe Herpes zoster infection (shingles): For normal immune status: 5 mg/kg every 8 hours
+- Varicella zoster infection: For immunocompromised immune status: 10 mg/kg every 8 hours
+- Herpes simplex encephalitis: For normal or immunocompromised immune status: 10 mg/kg every 8 hours
+
+Each dose should be administered by slow intravenous infusion over a one-hour period.
","It is recommended that Acyclovir IV Injection for Intravenous Infusion should be administered for five to seven days in the treatment of most infections and for at least ten days in the treatment of Herpes simplex encephalitis.
Acyclovir IV Injection after reconstitution may be injected directly into a vein over one hour by a controlled-rate infusion pump or be further diluted for administration by infusion. For intravenous infusion each vial of Acyclovir IV Injection should be reconstituted and then, wholly or in part according to the dosage required, added to and mixed with at least 50 mL-100 ml infusion solution. A maximum of 250 mg & 500 mg of Acyclovir may be added to 50 ml & 100 ml infusion solution respectively. After addition of Acyclovir IV Injection to an infusion solution the mixture should be shaken to ensure thorough mixing. Acyclovir IV Injection when diluted in accordance with the above schedule will give an Acyclovir concentration not greater than 0.5% w/v.
Acyclovir IV Injection is known to be compatible with the following infusion fluids and stable for up to 12 hours at room temperature (below 25°C) when diluted to a concentration not greater than 0.5% w/v Acyclovir.
+
+- Sodium Chloride Intravenous Infusion BP (0.45% and 0.9% w/v)
+- Sodium Chloride (0.18% w/v) and Glucose (4% w/v) Intravenous Infusion
+- Sodium Chloride (0.45% w/v) and Glucose (2.5% w/v) Intravenous Infusion
+- Compound Sodium Lactate Intravenous Infusion BP (Hartmann's Solution)
+
+Acyclovir IV Injection for Intravenous Infusion contains no preservative. Reconstitution and dilution should therefore be carried out immediately before use and any unused solution should be discarded. The solution should not be refrigerated.
","Co-administration of probenecid with Acyclovir has been shown to increase the mean Acyclovir half-life and the area under the concentration time curve. Urinary excretion and renal clearance correspondingly reduced. In patients over 60 years of age concurrent use of diuretics increases plasma levels of Acyclovir very significantly.
","Acyclovir IV Injection is contraindicated in patients known to be hypersensitive to Acyclovir or Valacyclovir.
","Some infrequent adverse reactions are lethargy, obtundation, tremors, confusion, hallucinations, agitation, somnolence, psychosis, convulsions and coma, phlebitis, nausea, vomiting, reversible increases in liver-related enzymes, pruritus, urticaria, rashes, increases in blood urea and creatinine. Local inflammatory reactions may occur if Acyclovir IV Infusion is inadvertently infused into extracellular tissues.
","Pregnancy category B. There have been no adequate and well controlled studies concerning the safety of Acyclovir in pregnant women. It should not be used during pregnancy unless the benefits to the patient clearly outweigh the potential risks to the fetus. Acyclovir should only be administered to nursing mothers if the benefits to the mother outweigh the potential risks to the baby. There is no experience of the effect of Acyclovir on human fertility.
","Acyclovir IV injection is intended for intravenous infusion only and should not be used through any other route. Reconstituted Acyclovir IV Infusion has a pH of approximately 11.0 and should not be administered by mouth. Acyclovir IV injection as infusion must be given over a period of at least one hour in order to avoid renal tubular damage. It should not be administered as a bolus injection. Acyclovir IV infusion must be accompanied by adequate hydration. Since maximum urine concentration occurs within the first few hours following infusion, particular attention should be given to establish sufficient urine ‑ow during that period. Concomitant use of other nephrotoxic drugs, pre-existing renal disease and dehydration increase the risk of further renal impairment by Acyclovir. As Acyclovir has been associated with reversible encephalopathic changes, it should be used with caution in patients with neurological abnormalities, significant hypoxia or serious renal, hepatic or electrolyte abnormalities.
","Pediatric use: The dose of Acyclovir IV injection in children aged 1-12 years should be calculated on the basis of body surface area. Children in this age group with Herpes simplex infections (except Herpes simplex encephalitis) or Varicella zoster infections should be given Acyclovir IV Infusion in doses of 250 mg/m
2 (equivalent to 5 mg/kg in adults). Immunocompromised children in this age group with Varicella zoster virus infection or with Herpes simplex encephalitis should be given Acyclovir IV Infusion in doses of 500 mg/m
2 (equivalent to 10 mg/kg in adults). Children with impaired renal function require an appropriately modified dose, according to the degree of impairment.
Geriatric use: No data are available on this age group. However, as creatinine clearance is often low in the elderly, special attention should be given to dosage reduction.
In patients with renal impairment: Acyclovir should be administered with caution since the drug is excreted through the kidneys. The following modifications in dosage are suggested:
+
+- CrCl: 25-50 ml/min: 5 or 10 mg/kg every 12 hours
+- CrCl: 10-25 ml/min: 5 or 10 mg/kg every 24 hours
+- CrCl: 0-10 ml/min: 2.5 or 5 mg/kg every 24 hours and after dialysis.
+
","Overdosage of intravenous Acyclovir has resulted in elevations of serum creatinine, blood urea nitrogen and subsequent renal failure. Neurological effects including confusion, hallucinations, agitation, seizures and coma have been described in association with over dosage. Adequate hydration is essential to reduce the possibility of crystal formation in the urine. Hemodialysis significantly enhances the removal of Acyclovir from the blood and may, therefore, be considered an option in the management of overdose of Acyclovir.
","It is recommended that Acyclovir IV Injection for Intravenous Infusion should be administered for five to seven days in the treatment of most infections and for at least ten days in the treatment of Herpes simplex encephalitis.
","Each 250 mg vial of Acyclovir IV Injection should be reconstituted by the addition of 10 ml of either Water for Injection or Sodium Chloride Intravenous Infusion (0.9% w/v). This provides a solution containing 25 mg Acyclovir per ml.
Each 500 mg vial of Acyclovir IV Injection should be reconstituted by the addition of 10 ml of either Water for Injection or Sodium Chloride Intravenous Infusion (0.9% w/v). This provides a solution containing 50 mg Acyclovir per ml.
","Store at 15°C to 25°C. Protected from light and moisture. Keep the medicine out of the reach of children.
",15
+22,Activated Charcoal,activated-charcoal-22,https://medex.com.bd/attachments/hwOAFkOm3RCLYx16xwRggNZC3RDN76/activated-charcoal-prescribing-information,Antidote preparations,"Poisoning due to foods, heavy meals & drugs","Diarrhoea & poisoning due to foods, heavy meals & drugs. Flatulence due to diet & other factors.
","Anti-diarrhoeal, Antidote preparations
","Active charcoal binds the poison and prevents its absorption by the gastrointestinal tract. In cases of suspected poisoning, medical personnel administer activated carbon on the scene or at a hospital's emergency department. In rare situations, it may also be used in a hemoperfusion system to remove toxins from the blood stream of poisoned patients. Activated carbon has become the treatment of choice for many poisonings, and other decontamination methods such as ipecac-induced emesis or stomach pumping are now used rarely. It interrupts the enterohepatic and enteroenteric circulation of some drugs/toxins and their metabolites.
","Diarrhoea:
+
+- Adult: 2-4 tab tds-qds.
+- Children: ½ adult dose.
+
+Poisoning:
+
+- Adult: 2-4 tab/kg body weight
+- children: 3-4 tab/kg body weight
+
+Flatulence:
+
+- Adult: Disintegrate 1-2 tab. Repeat every 2 hr.
+
",,"Ultracarbon should not be administered together with other drugs because their efficacy can be reduced.
","Febrile diarrhoea. Medicinal charcoal should not be taken in the case of intoxication with corrosive substances (strong acids and alkalis) as this would complicate diagnostic measures eg, oesophagoscopy and gastroscopy.
","As most undesirable effects are based on post-marketing spontaneous reporting, precise frequency estimation is not possible. No adverse reactions to Ultracarbon are known to occur if taken in the recommended dosage to treat the diarrhoea. After very high doses as those taken in intoxications, constipation and intestinal obstruction (mechanical ileus) may occur in individual cases; this can be prevented by administering saline laxatives (eg, sodium sulfate). As medicinal charcoal is excreted in unchanged form, the stools turn black (discoloured faeces) after intake of Ultracarbon tablets.
","No data found
","Several poisons and drugs require different or additional measures. Medicinal charcoal is not effective in intoxications with organic and inorganic salts as well as solvents eg, for instance, lithium, thallium, cyanide, iron salts, methanol, ethanol and ethylene glycol. Different measures are in these cases indicated to eliminate the poison (eg, gastric lavage).
In many intoxications, a specific antidote must be administered additionally to medicinal charcoal (eg, acetylcysteine in paracetamol poisoning).
To avoid aspiration in unconscious patients, a physician should administer the suspension of Ultracarbon tablets in water by gastric tube.
In patients undergoing multiple dose, activated charcoal therapy after intoxication, gastrointestinal sounds should be monitored frequently to assess peristaltic action.
Ultracarbon should not be used in cases of poisoning with pesticides.
",,"Activated charcoal is well tolerated and due to its lack of toxicity, overdose requiring treatment is unlikely. Should symptoms of overdose like constipation and intestinal obstruction (mechanical ileus) occur, a saline laxative may be administered to enhance the elimination of Ultracarbon tablets.
",,,"Do not store above 30°C.
",11
+2060,Aclidinium Bromide + Formoterol Fumarate,aclidinium-bromide-formoterol-fumarate-2060,,Combined bronchodilators,,"It is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
","Combined bronchodilators
","Aclidinium bromide: Aclidinium bromide is a long-acting anti-muscarinic agent, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptors at the smooth muscle leading to bronchodilation. The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations. In preclinical, in vitro as well as in vivo studies, prevention of acetylcholine-induced bronchoconstriction effects was dose-dependent and lasted longer than 24 hours. The clinical relevance of these findings is unknown. The bronchodilation following inhalation of aclidinium bromide is predominantly a site-specific effect.
Formoterol fumarate: Formoterol fumarate is a long-acting selective beta2-adrenergic receptor agonist (LABA) (beta 2-agonist). Inhaled formoterol fumarate acts locally in the lung as a bronchodilator. The pharmacologic effects of beta 2-adrenoceptor agonist drugs, including formoterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3', 5'-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
","For oral inhalation only. Should be taken by revolizer. 400 mcg/12 meg, twice daily (One inhalation capsule in the morning and one in the evening ). Do not take more than one inhalation twice daily.
",,"Use of other adrenergic by any route may potentiate the effect of this combination. Use with caution.
+
+- Xanthine derivatives, steroids, diuretics or non-potassium sparing diuretics may potentiate hypokalemia or ECG changes. Use with caution.
+- Diuretics: Electrocardiographic changes and/or hypokalemia associated with non-potassium sparing diuretics may worsen with concomitant beta2-agonists. Use with caution.
+- Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of formoterol fumarate on cardiovascular system.
+- Beta-blockers: Use with caution and only when medically necessary.
+- Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administrations of this combination with other anticholinergic-containing drugs.
+
","
+- Use of a long-acting beta 2-adrenergic agonist (LABA), including formoterol fumarate, one of the active ingredients in this combination, without an inhaled corticosteroid is contraindicated in patients with asthma.
+- Hypersensitivity to aclidinium bromide or formoterol fumarate or to any component of this product.
+
","Most common adverse reactions (incidence 3% and more common than with placebo) include: upper respiratory tract infection and headache.
","There are no adequate and well-controlled studies of Aclitol or its individual components, formoterol fumarate or aclidinium bromide, in pregnant women to inform drug-associated risks. There are no available data on the effects of aclidinium bromide, or formoterol fumarate on the breastfed child or on milk production or presence in human milk.
","
+- Asthma-related death: Long-acting beta2-adrenergic agonists as monotherapy (without an inhaled corticosteroid) for asthma increase the risk of serious asthma-related events.
+- Do not initiate in acutely deteriorating COPD or to treat acute symptoms.
+- Do not use in combination with additional medicine containing a LABA because of risk of overdose.
+- If paradoxical bronchospasm occurs, discontinue this combination and institute alternative therapy.
+- Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus and ketoacidosis.
+- Be alert to hypokalemia and hyperglycemia.
+- Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a physician immediately if symptoms occur.
+- Worsening urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to consult a physician immediately if symptoms occur.
+
",,,,,"Keep out of reach of children. Protect from light & moisture, Store below 25°C.
",10
+25,Acitretin,acitretin-25,https://medex.com.bd/attachments/tYDJBz2ptMyw7Rb8WW7fexbkAq7kS0/acitretin-prescribing-information,Oral Retinoid preparations,Scaly skin disease,"Acitretin is indicated in severe extensive psoriasis which is resistant to other forms of therapy, palmo-plantar pustular psoriasis, severe congenital ichthyosis, severe Darier’s disease (keratosis follicularis).
","Oral Retinoid preparations
","Acitretin is a retinoid, an aromatic analogue of vitamin A. The mechanism of action of acitretin is unknown, however, evidence exists for a wide range of actions at various cellular and subcellular levels. These include regulation of RNA/DNA synthesis, modulation of factors which influence epidermal proliferation, modification of glycoprotein synthesis and modulation of the immune response. Whatever the exact mechanism of action, the most prominent effect of acitretin is a modulation of cellular differentiation in the epidermis which re-establishes a more normal pattern of cell growth.
","Adult and elderly: Initial daily dose should be 25 mg or 30 mg for 2 to 4 weeks. After this initial treatment period the involved areas of the skin should show a marked response and/or side-effects should be apparent. In general, a daily dosage of 25-50 mg taken for a further 6 to 8 weeks to achieve optimal therapeutic results. However, it may be necessary in some cases to increase the dose up to a maximum of 75 mg/day.
In patients with Darier’s disease a starting dose of 10 mg may be appropriate. The dose should be increased cautiously as isomorphic reactions may occur. Patients with severe congenital ichthyosis and severe Darier’s disease may require therapy beyond 3 months. The lowest effective dosage, not exceeding 50mg/day, should be given. Continuous use beyond 6 months is contra-indicated as only limited clinical data are available on patients treated beyond this length of time.
Children: The daily dosage is about 0.5mg/kg. Higher doses (up to 1mg/kg daily) may be necessary in some cases for limited periods, but only up to a maximum of 35 mg/day.
",,"Existing data suggests that concurrent intake of acitretin with ethanol led to the formation of etretinate. Concomitant administration of methotrexate, tetracyclines or vitamin A and other retinoids with acitretin is contraindicated. In concurrent treatment with phenytoin, it must be remembered that Acitretin partially reduces the protein binding of phenytoin. Low dose progesterone-only products (minipills) may be an inadequate method of contraception during acitretin therapy, Investigations into the effect of acitretin on the protein binding of anticoagulants of the coumarin type (warfarin) revealed no interaction.
","Acitretin is highly teratogenic and must not be used by women who are pregnant. The same applies to women of childbearing potential unless strict contraception is practiced 4 weeks before, during and for 2 years after treatment. The use of Acitretin is contra-indicated in women who are breast feeding.Acitretin is contraindicated in patients with severe hepatic or renal impairment and in patients with chronic abnormally elevated blood lipid values. Concomitant administration of Acitretin with other retinoids or Vitamin A is contra-indicated due to the risk of hypervitaminosis A. Acitretin is contra-indicated in cases of hypersensitivity to the preparation (acitretin or excipients) or to other retinoids. Patients with rare glucose-galactosemalabsorption should not take this medicine.
","Adverse effects are seen in most patients receiving acitretin. Most of the clinical side-effects of Acitretin are dose-related and are usually well-tolerated at the recommended dosages. However, the toxic dose of Acitretin is close to the therapeutic dose and most patients experience some side-effects during theinitial period whilst dosage is being adjusted. The skin and mucous membranes are most commonly affected. An initial worsening of psoriasis symptoms issometimes seen at the beginning of the treatment period.
","Acitretin is contraindicated in pregnant women or nursing mother. It is highly teratogenic. Its use is contraindicated in women who might become pregnant during or within 2 years of the cessation of treatment.
","The risk of giving birth to a deformed child is exceptionally high if Acitretin is taken before or during pregnancy, no matter for how long or at what dosage. Women of childbearing potential must not receive blood from patients being treated with acitretin. Donation of blood by a patient being treated with acitretin is prohibited during and for two years after completion of treatment with acitretin. The effects of UV light are enhanced by retinoid therapy; therefore patients should avoid excessive exposure to sunlight. Hepatic function should be checked before starting treatment with Acitretin, every 1-2 weeks for the first 2 months after commencement and then every 3 months during treatment. Serum cholesterol and serum triglycerides (fasting values) must be monitored before starting treatment, one month after the commencement and then every 3 months during treatment, especially in high-risk patients and during long-term treatment. Retinoids can alter glucose tolerance, blood sugar levels should therefore be checked. Patients should be warned of the possibility of alopecia. Decreased night vision has been reported with acitretin therapy. Patients with severe headache, nausea, vomiting, and visual disturbances should discontinue acitretin immediately.
",,"Manifestations of acute Vitamin A toxicity include severe headache, vertigo, nausea or vomiting, drowsiness, irritability and pruritus. Signs and symptoms of accidental or deliberate overdosage with Acitretin would probably be similar. Specific treatment is unnecessary because of the low acute toxicity of the preparation.
",,,"Store in a cool & dry place, protected from light. Do not store above 25°C.
",11
+177,Acidic component [HCO3 Hemodialysis Solution],acidic-component-hco3-hemodialysis-solution-177,,Haemodialysis solutions,Haemodialysis,"This solution is used in Haemodialysis.
","Haemodialysis solutions
","Calcium chloride is used to prevent or treat negative calcium balance. It also regulates action potential excitation threshold to facilitate nerve and muscle performance.
Potassium chloride is a major cation of the intracellular fluid. It plays an active role in the conduction of nerve impulses in the heart, brain and skeletal muscle; contraction of cardiac skeletal and smooth muscles; maintenance of normal renal function, acid-base balance, carbohydrate metabolism and gastric secretion.
Sodium chloride is the major extracellular cation. It is important in electrolyte and fluid balance, osmotic pressure control and water distribution as it restores sodium ions. It is used as a source of electrolytes and water for hydration, treatment of metabolic acidosis, priming solution in haemodialysis and treatment of hyperosmolar diabetes. It is also used as diluents for infusion of compatible drug additives.
Magnessium Chloride acts as cofactor in numerous enzymatic reactions involving protein synthesis and carbohydrate metabolism; depresses CNS, blocks peripheral neuromuscular transmission, produces anticonvulsant effects.
","Recommended dose: 5 liters concentrate per dialysis or as required.
",,"There are no known drug interactions and none well documented.
","Known hypersensitivity to any of the ingredients of this preparation.
","Fluid and electrolyte imbalance, hypovolemia, hypotension or muscle cramping may occur.
","Pregnancy Category is not Classified. FDA has not yet classified the drug into a specified pregnancy category.
","It is used for hemodialysis purposes only. Do not use solution A or B alone. Discard container in case visible solid particles inside.
",,,,,,9
+6,Acetylcysteine,acetylcysteine-6,https://medex.com.bd/attachments/bWME7gJ1TpoYJ43oXYfS81UrClipoK/acetylcysteine-prescribing-information,Antidote preparations,Tuberculosis,"Acetylcysteine is indicated as an adjuvant treatment in certain clinical condition characterized by the presence of thick and viscous mucoid or mucopurulent secretions such as: Chronic bronchopulmonary diseases (chronic obstructive pulmonary disease, emphysema with bronchitis, chronic asthmatic bronchitis ... Read more
Acetylcysteine is indicated as an adjuvant treatment in certain clinical condition characterized by the presence of thick and viscous mucoid or mucopurulent secretions such as: Chronic bronchopulmonary diseases (chronic obstructive pulmonary disease, emphysema with bronchitis, chronic asthmatic bronchitis, bronchiectasis); Acute bronchopulmonary diseases (asthma with bronchial mucus plugging, bronchitis, bronchopneumonia, tracheobronchitis, bronchiolitis, pulmonary complications of cystic fibrosis, pulmonary complications associated with surgery).
","Antidote preparations, Cough expectorants & mucolytics
","Acetylcysteine is a mucolytic agent that reduces the viscosity of secretions probably by the splitting of disulphide bonds in mucoproteins. Moreover it gives antisecretory effect. These results in clearing of respiratory ducts and facilitate breathing. Acetylcysteine also has anti-oxidant properties by reacting with free radicals and also by serving as a precursor to glutathione, which is an important intra and extra-cellular antioxidant. By providing anti-oxidant action, it neutralizes exogenous and endogenous oxidants, which in fact act as pathogens in respiratory inflammations.
","Effervescent tablet or Dispersible tablet: Adults and children above 6 years: One effervescent tablet of Acetylcysteine 600 mg a day (preferably in the evening). The duration of treatment should be 5 to 10 days in the acute treatment, whereas it may be continued in the chronic states for several months, according to the advice of the physician. Dissolve the tablets in a glass containing a small quantity of water, mixing it, if necessary, with a spoon. A palatable solution is thus obtained, which can be drunk directly from the glass.
Effervescent Granules:
+
+- Adults and children above 6 years: 1 sachet Acetylcysteine 200 mg or 2 sachets Acetylcysteine 100 mg, 2-3 times a day.
+- Children (2-6 years of age): 1 sachet Acetylcysteine 100 mg from 2 to 4 times a day, according to the age.
+
+The duration of treatment should be 5 to 10 days in the acute treatment, whereas it may be continued in the chronic states for several months, according to the advice of the physician.
Dissolve the contents of the sachets in a glass containing a small quantity of water; mixing it, if necessary, with a spoon. A palatable solution is thus obtained, which can be drunk directly from the glass.
Nebuliser Solution: The 20% solution may be diluted to a lesser concentration with either Sodium Chloride for injection, Sodium Chloride for inhalation, sterile water for injection, or sterile water for inhalation.
+
+- Adult: 5-10 ml of 10% or 20% solution by Nebuliser every 6-8 hr PRN.
+- Children: 1-11 months: 1-2 ml of 20% or 2-4 ml of 10% solution by Nebuliser every 6-8 hr PRN.
+- 12 months-11 years: 3-5 ml of 20% or 6-10 ml of 10% solution by Nebuliser every 6-8 hr PRN.
+- Below 12 years: 5-10 ml of 10/20% solution by Nebuliser every 6-8 hr PRN.
+
+
** Diagnostic Bronchograms: 1-2 ml of 20% or 2-4 ml of 10% solution 2-3 times by Nebulisation or by instillation intratracheally prior to procedure.
** Nebulisation tent or croupette: This form of administration requires very large volumes of the solution, occasionally as much as 300 ml during a single treatment period. If a tent or croupette must be used, the recommended dose is the volume of acetylcysteine (using 20%) that will maintain a very heavy mist in the tent or croupette for the desired period. Administration for intermittent or continuous prolonged periods, including overnight, may be desirable.
** Direct Instillation: When used by direct instillation, 1-2 ml of a 20% solution may be given as often as every hour. When used for the routine nursing care of patients with tracheostomy, 1-2 ml of a 20% solution may be given every 1-4 hours by instillation into the tracheostomy.
",,"The thiol group of Acetylcysteine can reduce the efficacy of certain antibiotics such as ampicillin, tetracycline, macrolides, cephalosporins, aminoglycosides and amphotericin. Concomitant use of Acetylcysteine and amoxicillin will increase the level of the antibiotic in tissues. It is, therefore, advisable to use the two medicines 2 hours apart from each other. Acetylcysteine can increase the inhibitory effect of thrombocyte aggregation and vasodialation by nitroglycerine.
","Known hypersensitivity to Acetylcysteine. Acetylcysteine contains aspartame, thus it is contraindicated in patients suffering from phenylketonuria.
","Like all medicines, Acetylcysteine can cause side effects, although not everybody gets them. In very rare cases, severe immune reactions may occur such as anaphylactic shock and severe skin reaction. In rare cases the oral administration can be followed by shortness of breath, upset stomach and bronchospasm. The most frequent side effects are headache, increased heart rate, stomatitis, pruritus, urticaria, nausea, vomiting, abdominal pain, fever, decrease in the blood pressure, diarrhoea and noises in the ears.
","In case of pregnancy & lactation the medicine should be taken consulting physician or pharmacist.
","Patients suffering from bronchial asthma must be strictly controlled during the therapy; should bronchospasm occur, the treatment must immediately be suspended. Caution should be taken in patients suffering from or with a history of peptic ulcer. As Viscotin contains sodium (156.9mg per dose) this has to be taken into consideration by patients on a controlled sodium diet. The possible presence of a sulphureous odor does not indicate an alteration of the product but is a characteristic of the active ingredient contained in this preparation. It is preferable not to mix other drugs with the Viscotin solution.
",,"Overdose of Acetylcysteine may cause nausea, vomiting or diarrhoea.
",,,"Store in a cool and dry place, protected from light.
",11
+26,Acetazolamide,acetazolamide-26,https://medex.com.bd/attachments/7ErMDc36jBxgtwgTFbGUGuCuTncAlx/acetazolamide-prescribing-information,Carbonic anhydrase inhibitor,Tumor lysis syndrome,"Acetazolamide is indicated in open angle glaucoma, secondary glaucoma and as an adjuvant in the treatment of edema and epilepsy.
","Carbonic anhydrase inhibitor
","Acetazolamide is a carbonic anhydrase inhibitor. This enzyme catalyzes the reversible reaction involving the hydration of carbon-di-oxide and the dehydration of carbonic acid. In the eye, this inhibitory action of Acetazolamide decreases the secretion of aqueous humor and results in a drop in intraocular pressure, a reaction considered desirable in case of glaucoma. Inhibition of carbonic anhydrase in the central nervous system appears to retard abnormal paroxysmal and excessive discharge from central nervous system neurons. So, Acetazolamide is also used as an adjuvant in the treatment of epilepsy.
","Adults : Initially 250 mg (1 tablet) 4 times daily. Dose should be adjusted later with individual need.
Children : ½ to 2 tablets in divided doses.
In intraocular pressure: 1 tablet 6 hourly. In acute condition, dose should be started with 2 tablets followed by 1 tablet 6 hourly or as directed by the physician
",,,"Acetazolamide is contraindicated in cases of marked kidney and liver diseases or dysfunction, in situations in which sodium and or potassium blood serum levels decreased. Acetazolamide is also contraindicated in patients with chronic noncongestive angle closure glaucoma
","Common side effects are headache, drowsiness, dizziness, fatigue, anorexia, polyurea, insomnia, gastrointestinal upset.
","There are no adequate and well controlled studies in pregnant women and neonates. So, Acetazolamide should be used with care in those physiological conditions.
",,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",8
+184,Acetate Formulation [Hemodialysis Solution],acetate-formulation-hemodialysis-solution-184,,Haemodialysis solutions,Haemodialysis,"This solution is used for haemodialysis.
","Haemodialysis solutions
","Calcium chloride is used to prevent or treat negative calcium balance. It also regulates action potential excitation threshold to facilitate nerve and muscle performance.
Potassium chloride is a major cation of the intracellular fluid. It plays an active role in the conduction of nerve impulses in the heart, brain and skeletal muscle; contraction of cardiac skeletal and smooth muscles; maintenance of normal renal function, acid-base balance, carbohydrate metabolism and gastric secretion.
Magnessium Chloride acts as cofactor in numerous enzymatic reactions involving protein synthesis and carbohydrate metabolism; depresses CNS, blocks peripheral neuromuscular transmission, produces anticonvulsant effects.
Sodium chloride is the major extracellular cation. It is important in electrolyte and fluid balance, osmotic pressure control and water distribution as it restores sodium ions. It is used as a source of electrolytes and water for hydration, treatment of metabolic acidosis, priming solution in haemodialysis and treatment of hyperosmolar diabetes. It is also used as diluents for infusion of compatible drug additives.
","Recommended dose: 5 liters concentrate per dialysis or as required.
",,"There are no known drug interactions and none well documented.
","Known hypersensitivity to any of the ingredients of this preparation
","Fluid and electrolyte imbalance, hypovolemia, hypotension or muscle cramping may occur.
","Pregnancy Category-not Classified. FDA has not yet classified the drug into a specified pregnancy category.
","It is used for haemodialysis purposes only.
",,,,,,9
+21,Acemetacin,acemetacin-21,https://medex.com.bd/attachments/Y77vDUVBSO8oAj3lWNQcYxV8NqUB9v/acemetacin-prescribing-information,Non-steroidal Anti-inflammatory Drugs (NSAIDs),Spondylitis,"Acemetacin is indicated in
+
+- Pain & inflammation associated with musculoskeletal & joint disorders. Such as: Rheumatoid arthritis, Osteoarthritis, Low back pain.
+- Pain after an operation.
+
","Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Acemetacin is a non-steroidal anti-inflammatory drug. It is also known as an NSAID. It works by blocking a substance in the body called cyclooxygenase (also known as COX) which is involved in the production of certain irritant chemicals in response to injury or rheumatic disease. By blocking the action of COX, Acemetacin reduces the symptoms of pain and inflammation.
","The recommended starting dose is 120mg/day in divided doses, increasing to 180mg/day in divided doses, depending on patient response. For the treatment of elderly patients, adjustment of dosage is not normally required. However, NSAIDs should be used with particular care in older patients who may be more prone to adverse reactions. Acemetacin should be taken with food, milk or an antacid to reduce the possibility of gastro-intestinal disturbance
",,"Acemetacin reduces the antihypertensive effect of b-blockers. Increase risk of convulsion when used with quinolone. Concurrent use with aspirin, NSAIDs or corticosteroids may increase risk of GI bleeding. Increased risk of methotrexate toxicity when used together.
","Acemetacin is contraindicated to known hypersensitivity to Acemetacin or Indomethacin; peptic ulcer; safety in children is not established.
","Common side effects include anorexia, nausea, vomiting, diarrhoea and constipation, peptic ulceration, headache, dizziness & vertigo. Rarely confusion, depressed mood, oedema, chest pain, blood urea elevation are found.
","The safety of this medicine in human pregnancy and lactation has not been established. Some animal reproduction studies showed some toxic/ teratogenic effects on fetus. Therefore, use of this drug during pregnancy and lactation period is not recommended.
","Caution should be taken in elderly people, history of disorders affecting the stomach or intestines, inflammatory bowel disease such as Crohn's disease or ulcerative colitis, kidney disease, liver disease, heart failure.
",,,,,"Store in a cool and dry place, below 25℃ and away from light.
",10
+3,Aceclofenac,aceclofenac-3,https://medex.com.bd/attachments/COVuU99iLCxjdgXktOCU5Vyl8OhfvE/aceclofenac-prescribing-information,Drugs for Osteoarthritis,Spondylitis,"Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, toothache, trauma and lumbago.
","Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.
","Extended release tablet: The recommended dose in adults is one 200 mg Aceclofenac tablet daily or as prescribed by the physician.
Film coated tablet: The recommended dose in adults is 100 mg, twice daily.
",,"No significant drug interactions has not been observed but close monitoring of patients is required when it is used with:
+
+- Lithium and Digoxin: may increase plasma concentration of lithium and digoxin.
+- Diuretics: may interact the activity of diuretics.
+- Anticoagulants: may enhance the activity of anticoagulant.
+- Methotrexate: may increase the plasma level of methotrexate.
+
","Aceclofenac is contraindicated in patients with known hypersensitivity to it or in whom aspirin or NSAIDs precipitate attacks of asthma.
","Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.
","The use of Aceclofenac should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
","Caution should be exercised to patients with active or suspected peptic ulcer or gastro-intestinal bleeding moderate to severe hepatic impairment and cardiac or renal impairment. Caution should also be exercised in patients suffering from dizziness or urticaria.
","There are no clinical data on the use of Aceclofenac in children.
",,,,"keep in a dry place away from light and heat. Keep out of the reach of children.
",11
+1723,"Bandish [Oak Galls, Tannic acid]",bandish-oak-galls-tannic-acid-1723,,Herbal and Nutraceuticals,Menorrhagia,"This is indicated in-
+
+- Epistaxis
+- Menorrhagia
+- Blood dysentery
+- Bleeding haemorrhoid
+
","Herbal and Nutraceuticals
","This is a unique medicine, prepared with the synergistically acting valuable natural ingredients, which is highly effective in menorrhagia, haemorrhage, haemorrhoid, blood dysentery and epistaxis. It is safe and effective.
","2 tablets twice daily or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in the therapeutic dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1619,Balarista,balarista-1619,,Herbal and Nutraceuticals,Painful muscle spasm,"This syrup is effective in physical debility, boosts strength & energy, improves the muscle tone, excellent tonic for sportsmen and asthma patients, useful in debility after fever and painful condition especially in sportsmen and geriatric patients.
","Herbal and Nutraceuticals
","Sida cordifolia: Sida cordifolia contains ephedrine, acts as a CNS stimulant. It produces strength and encourages muscular tone. Constituents include ephedrine (1%) and phytosterols. Sida cordifolia is also effective as an antiasthmatic as it contains some bronchodilating alkaloid. It would be useful for people who participate in outdoor sports rather than people who participate in indoor sports.
Withania somnifera: Root contains several alkaloids like withasomines, withanolides and steroidal lactones. It is adaptogen, anti- inflammatory, anxiolytic, immunomodulator, tonic and aphrodisiac.
Vanda roxburghii: The roots are used in bronchitis & rheumatism. Heptacosane and octacosanol shows anti-inflammatory activity.
Ricinus communis: Eranda is sweet, light, bitter and purgative. Castor oil is especially adapted for young children and child bearing women. It is a reputed remedy for all kinds of rheumatic affections. It cures dyspnoea, flatulence, visceral pain, lumbago and headache.
Elettaria cardamomum: Elettaria cardamomum has carminative and stimulant properties.
Syzygium aromaticum: The eugenol and acetyl eugenol of Syzygium aromaticum oil inhibit arachidonate-adrenaline and collagen induced platelet aggregation.
Vetiveria zizanoides: Its root is tonic,diuretic, stomachic and antispasmodic. It contains essential oil with some other alkaloids which act on dyspepsia, indigestion, diarrhea and vomiting.
Tribulus terrestris: Seed acts as a tonic. It improves vitality and luster of the skin to prevent wrinkle. It also acts as a uterine tonic and used in debility after child birth.
","Adult (above 12 years): 1-2 teaspoonfuls (5-10 ml) three times a day.
",,,"There is no evidence available on contraindication. But caution should be taken in hypertension, DM, BPH, cardiovascular diseases and with other CNS stimulant.
","This is well tolerated within the recommended dose.
","It is not recommended during pregnancy.
",,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",8
+1524,Bacopa extract [Natural memory enhancer],bacopa-extract-natural-memory-enhancer-1524,,Herbal and Nutraceuticals,Epilepsy,"This syrup is indicated in deficit/Cognitive deficit, Age Associated Memory Impairment (AAMI), Attention Deficit Disorder (ADD), Dementia, Convulsion and Epilepsy in children, Alzheimer’s disease, Autistic Spectrum Disorder (ASD) and Drug addiction.
","Herbal and Nutraceuticals
","The triterpenoid saponins and other bacosides are responsible for Bacopa’s ability to enhance nerve impulse transmission. The bacosides aid in repair of damaged neurons by enhancing kinase activity, neuronal synthesis, restoration of synaptic activity and modulating the cholinergic and GABAergic neurotransmission, and ultimately improves nerve impulse transmission.
Bacosides appear to have antioxidant activity in the hippocampus, frontal cortexand striatum. Bacopa extracts modulate the expression of certain enzymes involved in generation and scavenging of reactive oxygen species in the brain. It exerts a protective effect against DNA damage in astrocytes and human fibroblasts.
Asparagus racemosus is a well-known nervine tonic. It plays the role of an antioxidant by attenuating free radical induced oxidative neural damage. Antioxidant compound racemofuran of AR shows an enhancement in glutathione peroxidase (GPx) activity and glutathione content, and reduction in membranal lipid peroxidation and protein carbonyl.
","2-5 years:1 teaspoonful (5 ml) 2-3 times daily after meal for three months.
6-12 years: 1-2 teaspoonful (5-10 ml) 2-3 times daily after meal for three months.
Above 12 years and Adult: 2-3 teaspoonfuls (10-15 ml) 3 times daily after meal for three months.
",,"Bacopa may potentiate the activity of thyroid stimulating drugs or decrease the effects of anti-thyroid medications. It is important to note that this effect is not typically expected at the normal therapeutic dose for humans. Bacopa may work to decrease the toxicity of several drugs like morphine, and other opiate drugs. It has also been shown to reduce the decline in cognitive function associated with phenytoin, an anti-seizure medication.
","Bacopa is well tolerated but caution should be taken in hyperthyroidism, fever and acute infection. Patients with medical conditions should talk to their doctors before taking Bacopa.
","There are no side effects associated with the use of Bacopa in the above mentioned therapeutic doses. Bacopa has been used safely as an Ayurvedic medicine for hundreds of years.
","Women who are pregnant or nursing are advised to consult with a physician prior to use Bacopa. Although medical literature has not reported any adverse effects related to fetal development during pregnancy or to infants who are breast-fed.
",,,,,,"Keep in a cool, dry place & away from direct sunlight. Keep the medicine out of the reach of children.
",9
+1519,Aushokarist [Saraca Indica],aushokarist-saraca-indica-1519,https://medex.com.bd/attachments/ACrGdxOJ204fNImD9fEr392wLmsUbk/aushokarist-saraca-indica-prescribing-information,Herbal and Nutraceuticals,Polycystic ovarian syndrome,"Aushokarist is indicated in-
+
+- Dysfunctional uterine bleeding (DUB)
+- Secondary amenorrhea
+- Menorrhagia
+- Polycystic ovarian syndrome (PCOS)
+- Infertility.
+
","Herbal and Nutraceuticals
","Saraca indica is one of the most popular remedy for menstrual disorders and female hormonal imbalances. The principal constituents of this tree are steroidal component and a calcium salt. The bark of Saraca indica contains an estrogenic compound called ergosterol. Other important chemical contents of Saraca indica are alkene esters, tannin, catachin, catechole and epicatechin.
The herb has a stimulatory effect on the ovarian tissue, which may produce an estrogen-like activity that enhances ovulation and repair of the endometrium. It is a potent haemostyptic agent, also having stimulating effect on the muscular fiber of the uterus. It nourishes the blood, female reproductive organ and maintains healthy production of female hormones. It helps to regulate the menstrual cycle by controlling hypothalamic-pituitary-ovarian axis. Saraca indica, a proven PGH2 synthetase inhibitor, which effectively controls bleeding.
Saraca indica is recommended in formulations for the management of pain with relation to uterus as anodynes. Beside these, the herb also has significant broad spectrum antibacterial activity. Mangifera indica is astringent, antiemetic and useful in haematocoagulatory disorders, uterine inflammation and diseases. It is an excellent vitalizer of the female genitourinary tract and tones it up to protect from number of disorders. It cures the menstrual pain and controls the uterine activity.
It has also an antibacterial and antiviral properties. Cyperus rotundus is effective in the treatment of anemia and general weakness. Adhatoda vasica has antihemorrhagic activities and it is beneficial in dysfunctional uterine bleeding and an useful remedy in disorders of the uterus. The combined action of all these herbs help in ovulation, conception and proper implantation, which ultimately lead to normal pregnancy. The possible mechanism of combind ingredients of could be attributed to their synergistic action
","Above 12 years and Adult: 2-3 teaspoonfuls (10-15 ml) 2-3 times daily after meal for 3-6 months or as directed by the physician
",,,,"No health hazards or side effects are known in conjunction with the proper administration of designated therapeutic dosages.
","Should not be used.
",,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",7
+1758,Aswagandharista,aswagandharista-1758,,Herbal and Nutraceuticals,Libido,"This is indicaed in Nervous debility, Reduce libido, Insanity, Insomnia, Swooning (Syncope) & General decay.
","Herbal and Nutraceuticals
","Withania somnifera: It is sedative, tonic, stimulant, aphrodisiac, adaptogenic & alterative. It restores loss of memory and is used in cases of nervous exhaustion, spermatorrhoea and senile debility. In modern research, it has been compared to Panax ginseng for its endurance-enhancing properties. This is considering being an important vajikaron drug, capable of promoting the semen and sexual vigor.
Curculigo orchioides: Musali is a reputed rasayan (rejuvenative) drug and a good aphrodisiac medicine. It improves complexion and is useful in general debility & impotence.
Vanda roxburghii: The root is used in bronchitis, rheumatism & nervine weakness. Charaka recommend rasna in maintaining the youthful vigor and strength.
Ipoema paniculata: It is aphrodisiac, alterative, sweet, cooling, restorative & tonic. It is used to increase weight reduced due to mental & physical fatigue. The drug is recommended in all cases of general debility and rheumatism.
","Adult: 2-4 teaspoonful 2-3 times daily after meal
Children: 1-2 teaspoonful 2-3 times daily after meal or as prescribed by the physician.
",,,"There is no absolute contraindication.
","There is no significant side effect.
","No restriction known.
",,,,,,"Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.
",8
+1757,Ashokarista,ashokarista-1757,,Herbal and Nutraceuticals,Uterine bleeding,"Ashokarista is indicated in Premenstrual syndrome, Menstrual irregularities, Dysmenorrhoea and Dysfunctional uterine bleeding.
","Herbal and Nutraceuticals
","
+- Saraca indica: It contains estrogenic compound ketosterol, catechol, organic Calcium compound, Sodium, Potassium, Phosphate, Magnesium, Iron, tannin etc. It has a stimulatory effect on the endomatrium & ovarian tissue and may produce an estrogen like effect that enhances repair of the endometrium and stops bleeding. It is useful in menorrhagia, dysmenorrhoea, leucorrhoea and internal bleeding.
+- Woodfordia fruticosa: It contains octacosanol, b -sitosterol polystachoside, ellagic acid and polyphenols. Ellagic acid is known to have astringent and haemostatic properties and is useful in dysentery, diarrhoea, leucorrhoea and menorrhagia.
+- Nigella sative: It is used in the treatment of menstrual & digestive disorders.
+- Cyperus rotundus: It contains essential oils, rich amount of Cu, Mg, Mn and Ni etc. It relieves spasms and pain, acting mainly on digestive system and uterus. It is used in the treatment of digestive problems and menstrual complaints.
+- Zingiber officinale: It has anti-inflammatory, antithrombotic, antiemetic, antilipid & antioxidant effects. Its antiinflammatory effect is thought to be due to inhibition of cyclooxygenase and 5-lipoxygenase resulting in reduced leukotriene and prostaglandin synthesis.
+- Berberis aristata: It has antiinflammatory & antibacterial activities. It is used in menorrhagia and leucorrhoea.
+- Nymphaea lotus: It is astringent, demulcent stomachic & restorative and is used in dysentery, diarrhoea, leucorrhoea & general debility.
+- Terminalia chebula: It is stomachic, laxative, tonic etc. It has adaptogen and anti stress activity. It promotes digestive power and heals wound.
+- Terminalia belerica: It contains tannin, b-sitosterol, gallic acid, ellagic acid etc. It is used in inflammations, bronchitis, asthma, dyspepsia etc.
+- Phyllanthus emblica: It is highly nutritious and an important dietary source of vitamin C, minerals and amino acids. It is useful in hemorrhage, anaemia, and leucorrhoea.
+- Mangifera indica: It is astringent, anthelmintic and used in diarrhoea, uterine hemorrhage and other discharges.
+- Adhatoda vasica: It contains vasicine alkaloids and essential oil. It is a rich source of vitamin C and carotene. It has strong coagulant action, which is very useful to minimize blood loss and also possesses uterine stimulatory activity and acts as uterine tonic. It is also useful for the control of postpartum hemorrhage.
+- Pterocarpus santalinus: It is astringent, antipyretic, diaphoretic and is used in inflammation, wound healing, vomiting and hemophilic disorders associated menstrual disorders.
+
","Adult: 1-2 teaspoonful 1-2 times daily after meal or or as directed by the physician.
",,,"Contraindicated during pregnancy.
","Not yet known.
",,,,,,,"Keep all medicines out of reach of children. Store in a cool and dry place protected from light.
",7
+1744,Arjunarista,arjunarista-1744,,Herbal and Nutraceuticals,Asthma,"Arjunarista is indicated for the prevention & treatment of
+
+- Cardiac palpitation
+- Cardiopathy
+- Cardiac asthma
+- Physical debility
+
","Herbal and Nutraceuticals
","Terminalia arjuna: It contains tannins, beta-sitosterol, arjunolic acid, flavonoids, triterpenoids, and saponins. It is cardiotonic and diuretic. It is used in cardiac palpitation, cardiopathy, physical debility, high blood pressure, asthma, bronchitis and hyperhydrosis.
Vitis vinifera: It contains tannins ( proanthocyanidins), flavonoids, tartaric acid, malic acid, citric acid, oxalic acid which shows positive effects against peripheral venous insufficiency. It has anti- oxidant, ischemia preventive and anti-atherosclerotic effect.
Madhuca indica: It contains glycoside, saponin, sapogenin, beta sitosterol and sterol glycoside. It is used in constipation, tonsillitis and pharyngitis.
Woodfordia fruticosa: It contains ellagic acid, beta sitosterol and octacosanol. It has cooling, stimulant and astringent effect. It is used in disorders of mucous membrane.
","Adult: 2-4 teaspoonful 2-3 times daily after meal.
Children: 1-2 teaspoonful 2-3 times daily after meal.
",,,"There is no absolute contraindication.
","There is no significant side effect.
",,,,,,,"Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.
",7
+1745,Aravindasav,aravindasav-1745,,Herbal and Nutraceuticals,Malnutrition,"This insindicated in-
+
+- Malnutrition
+- Indigestion
+- Immune deficiency
+- Dysentery
+- Worm
+
","Herbal and Nutraceuticals
","Roktoutpol (Nymphaea lotus): It has bioflavonodis, glucose, fructose, sucrose, galacturonic acid and amino acids. It is used as a key to good health. Its rhizomes are cooling, sweet, tonic and used in diarrhea, dysentery, dyspepsia and general debility. It is also used internally in the treatment of gastrointestinal disorders and jaundice.
Draksha (Vitis vinifera): It contains sugar, gum, tannin, tartaric, citric, racemic and malic acids, chlorides of potassium and sodium, iron, albumin etc. It is used as demulcent, diuretic, laxative, stomachic and tonic. It is also used in dyspepsia.
Dhaiful (Woodfordia fruticosa): It has cooling and anthelmintic properties. It is stimulant & astringent. It is used in dysentery, disorders of mucous membrane. It is also used in headache and fever.
Haritaki (Terminalia chebula): It contains chebulin, tanic acid, gallic acid, resin etc. Chebulin exhibited antispasmodic action on smooth muscle. It is digestive, antiseptic and carminative. It promotes digestive power. It is also used in diarrhea, dysentery, colic and enlarged spleen and liver.
Amalaki (Phyllanthus emblica): It is a rich dietary source of vitamin C, minerals, flavonoids, amino acids and also contains a wide variety of phenolic compounds such as tannins, phyllembelic acid, phyllemblin, mucic acid and emblico. It balances stomach acids and enhances food absorption. It also increases body immunity and nourishes the brain and mental function. It is used medicinally for the treatment of diarrhea.
","6 month above to 5 years of children: 1/2 -1 tea-spoonful 2 times daily.
5 years above of children: 1-2 tea-spoonful 2 times daily.
",,,"There is no evidence available on contraindication but it may happen in-patient who is hypersensitive to any of its ingredients.
","No side effect in the above mentioned therapeutic doses.
",,,,,,,"There is no evidence available on contraindication but it may happen in-patient who is hypersensitive to any of its ingredients.
",7
+1695,Antacid [Unani],antacid-unani-1695,,Herbal and Nutraceuticals,Peptic ulcer disease,"This preparation is indicated in-
+
+- Peptic ulcer
+- Hyperacidity
+- Dysentery
+- Constipation
+- Gastritis
+- Flatulence
+
","Herbal and Nutraceuticals
","This preparation is an effective preparation of Psyllium, gum mastic and other herbal ingredients for peptic ulcer and hyperacidity. This preparation acts as prebiotic (due to presence of Psyllium), which stimulates the growth and activity of probiotics (beneficial bacteria) in the intestine. Probiotic helps to combat pathogenic bacteria that help to ensure better health. This preparation is also effective in the treatment of dysentery and constipation.
","Peptic ulcer & hyperacidity: 1 sachet twice daily before meal with half glass of water.
Dysentery: 1 sachet 4 times daily. Constipation: 1 sachet at bed time with plenty of water.
Gastritis & flatulence: 1 sachet twice daily before meal with water.
Dysentery: 1 sachet 4 times daily or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place protect from light.
",8
+1719,Aniseed + Indian dill + Black cardamom + Peppermint,aniseed-indian-dill-black-cardamom-peppermint-1719,,Herbal and Nutraceuticals,Indigestion,"For digestive disorders and teething troubles, it is a palatable way to fight against griping, flatulence, convulsions, diarrhoea and indigestion, so common among infants and teething children.
","Herbal and Nutraceuticals
","This is specially made for the proper growth and development of infants and children. It is totally free of alcohol and chemical that may be harmful to their delicate systems. This contains curative herbs and natural oils in a modern formulation that relieves stomach pain and gently soothes the digestive system.
","Up to 6 months: 1/2 teaspoonful
6 months to 1 year: 1 teaspoonful
1 year & above: 2 teaspoonfuls 3-4 times daily or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been reported in therapeutic dosage.
",,"Keep out of reach of the children.
",,,,,"Store in cool and dry place, protect from light.
",8
+1523,Andrographis paniculata,andrographis-paniculata-1523,,Herbal and Nutraceuticals,Sinusitis,"Andrographis paniculata is indicated in-
+
+- Viral fever
+- Flu
+- Common cold
+- Sinusitis
+- Upper respiratory tract infection
+- Viral hepatitis.
+
","Herbal and Nutraceuticals
","Andrographis compounds have shown antiviral properties which appear to inhibit glycoproteins in the virus. This impedes the ability of viruses to invade cells and replicate. It also has a major effect activating the general defense functions of the immune system by stimulating the production of antibodies as well as non-specific immune responses such as increased macrophage phagocytosis, rather than by any direct antimicrobial activity. Andrographis has flavonoids, which always have an anti-inflammatory effect. In vitro studies have shown that the flavonoid activities suppressed the genetic expression of neutrophils. Similarly, studies have indicated that a variety of inflammatory proteins, including COX-2, are reduced by the presence of Andrographoloid.
The aerial parts and their constituent andrographolides have antihepato-toxic activity in vitro and in vivo. In vitro studies have shown that intraperitoneal administration of a methanol extract of the aerial parts to mice reduced hepatotoxicity induced by carbon tetrachloride CCl4, and reversed CCl4 induced histopathological changes in the liver. Intraperitoneal administration of andrographolide to mice inhibited the CCl4 induced increase in the activity of serum glutamate oxaloacetate transaminase, serum glutamate pyruvate transaminase, alkaline phosphatase, bilirubin and hepatic triglycerides. Andrographolide, the major antihepatotoxic component of the plant, exerted a pronounced protective effect in rats against hepato-toxicity induced by CCl4, Dgalactosamine, paracetamol and ethanol.
Moreover, andrographolide and related diterpenes are choleretic, antidiarrheal, immunostimulant, antimalarial, antipyretic and active in urinary tract infections.
","Age 18 and above: 1 capsule 3 times daily after meal for 5 to 10 days.
12 to 17 years: 1 capsule 2 times daily after meal for 5 to 10 days.
4 to 11 years: 1 capsule daily after meal for 5 to 10 days or as directed by the physician.
",,"May have a synergistic effect with isoniazid.
","Andrographis is contraindicated in cases of known allergy to plants of the acanthaceae family
","Large oral doses may cause gastric discomfort, vomiting and loss of appetite. These side-effects appear to be due to the bitter taste of andrographolide.
","Andrographis should not be used during pregnancy or lactation.
",,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+1737,Ambergris + Salep + Galangal,ambergris-salep-galangal-1737,,Herbal and Nutraceuticals,To develop immune system,"
+- Strengthens vital organs.
+- Removes foul smell of mouth.
+- Acts as a powerful antioxidant.
+- Boosts up immune system.
+- Helps in regaining lost vigour & vitality.
+- Strengthens the reproductive organs.
+- Prevents the symptoms of early aging & senile debility.
+
","Herbal and Nutraceuticals
","This is a versatile polypharmaceutical modern unani medicine with judicious combination of synergistically acting precious natural ingredients which restores physical strength, psychological strength, physiological strength and vital energy. This is being used successfully to treat patient of general debility, senile debility, nervine debility, paralysis, mental depression, sexual debility and foul smell of mouth. It is easily assimilable and more effective.
","1 capsule/tablet twice daily or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1699,Ambar Momiyaee,ambar-momiyaee-1699,,Herbal and Nutraceuticals,Erectile dysfunction,"Ambar Momiyaee-
+
+- Combats erectile dysfunction.
+- Is an ideal aphrodisiac and nervine tonic.
+- Restores sex hormone and depleted sexual power.
+- Relieves limpness and weakness after coitus.
+- Enhances retentive power.
+- Tones up the vital organ of the body.
... Read more
Ambar Momiyaee-
+
+- Combats erectile dysfunction.
+- Is an ideal aphrodisiac and nervine tonic.
+- Restores sex hormone and depleted sexual power.
+- Relieves limpness and weakness after coitus.
+- Enhances retentive power.
+- Tones up the vital organ of the body.
+- Removes mental depression.
+- Its continuous use serves as a good general tonic.
+
","Herbal and Nutraceuticals
","Ambar Momiyaee is a research product of Hamdard Laboratories and time tested aphrodisiac. Ambar Momiyaee is being used successfully to treat the patients of erectile dysfunction in different Hamdard clinics of the subcontinent for long time. It acts as nervine tonic and continuous use serves as a good general tonic.
","1 tablet twice daily to be taken with milk or as prescribed by the physician.
",,,"It is contraindicated for women and children.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1743,Amalaki Rasayana,amalaki-rasayana-1743,,Herbal and Nutraceuticals,Hyperacidity,"This in indicated in-
+
+- Hyperacidity
+- Indigestion
+- Dyspepsia
+- Anorexia
+- Flatulence
+- Anaemia
+- Jaundice and
+- Increase body immunity
+
","Herbal and Nutraceuticals
","Phyllanthus emblica-
+
+- Active Constituents: Phyllantidine, tannins, phyllenbic acid, gallic acid, ellagic acid and large amount of vitamin-C.
+- Actions: It is used as antacid, stomachic, carminative and antioxidant due to gallic acid. It is used in hyperacidity, anorexia, dyspepsia, jaundice, flatulence and gastrointestinal disorders.
+
+Piper longum-
+
+- Active constituents: Piperine, Piplartine, Piperlonguminine, sesamine volatile oil etc.
+- Actions: It is used as carminative, digestive, strengthen muscular system and nervine tonic. It can be used in anaemia, ascites, hemorrhoids, colic and splenic disorder.
+
","Adult: 2-4 teaspoonful 2-3 times daily after meal.
Children: 1-2 teaspoonful 2-3 times daily after meal.
",,,"There is no contraindication.
",,,,,,,,"Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.
",6
+1742,Aloe indica+ Hyoscyamus niger + Piper nigrum,aloe-indica-hyoscyamus-niger-piper-nigrum-1742,,Herbal and Nutraceuticals,Piles,"This is indicated in-
+
+- Acid reflux
+- Gastric ulcer
+- Obesity
+- Constipation
+- Piles
+
","Herbal and Nutraceuticals
","Aloe indica royle: Aloe contains anthrone -10-C-glycosyls, including aloin A, aloin B, 7-hydroxyaloin and 1,8-dihydroxy anthraquinone, including Aloe-emodin. The 2015 study found that aloe effectively reduced the symptoms of acid reflux as well as certain traditional medication without any reported side effects. Researchers concluded that aloe may work by reducing acid production and acting as an anti-inflammatory agent. By taking Aloe regularly, ensures a better sensation of well-being, allowing energy levels to increase and also helps maintain a healthy body weight. Aloe is a best natural aid for detoxification. Aloe is colonic-specific stimulant laxatives that have a direct action on intestinal mucosa, increasing the rate of colonic motility and inhibiting water & electrolyte secretion. Anthraquinones may also have stool softening properties.
Hyoscyamus niger: It contains the alkaloids hyoscyamine and scopolamine. It is used to provide symptomatic relief of spasms caused by various lower abdominal and bladder disorders including peptic ulcers, irritable bowel syndrome, colic & cystitis.
Piper nigrum: It contains 3, 4-dihydroxy phenyl ethanol glycosides, piperine, polysac- charides, fatty oil & volatile oil. It stimulates the thermal receptors and increases secretion of saliva and gastric mucus. It influences liver metabolic functions.
","1-2 tablets daily at bedtime.
",,"Antiarrhythmic agents, diuretic agents & corticosteroids.
","Intestinal pathological narrow or obstruction & acutely inflamed intestinal diseases, e.g, Crohn’s disease, ulcerative colitis & appendicitis.
","Occasionally allergic reaction may occur. Chronic use may cause loss of electrolytes (Potassium) that will reverse upon discontinuation.
","Should not be used during Pregnancy. There is no sufficient information for use in lactation.
",,,"Overdose may alter electrolyte and water balance.
",,,"Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.
",10
+17,Allopurinol,allopurinol-17,https://medex.com.bd/attachments/3v6AQUtJHmxoDGK0JQ0ibdVSvAXLHX/allopurinol-prescribing-information,Drugs used in Gout,Uric acid nephropathy,"Allopurinol is indicated for reducing urate/uric acid formation in conditions where urate/uric acid deposition has already occurred (e.g. gouty arthritis, skin tophi, nephrolithiasis). Allopurinol is indicated for management of 2,8-dihydroxyadenine (2,8-DHA) renal stones related to deficient activity ... Read more
Allopurinol is indicated for reducing urate/uric acid formation in conditions where urate/uric acid deposition has already occurred (e.g. gouty arthritis, skin tophi, nephrolithiasis). Allopurinol is indicated for management of 2,8-dihydroxyadenine (2,8-DHA) renal stones related to deficient activity of adenine phospho ribosyltransferase. Allopurinol is indicated for the management of recurrent mixed calcium oxalate renal stones in the presence of hyperuricosuria, when fluid, dietary and similar measures have failed.
","Drugs used in Gout
","Allopurinol is a xanthine oxidase inhibitor which is administered orally. It acts on purine catabolism without disrupting the biosynthesis of purines. It reduces the production of uric acid by inhibiting the biochemical reactions immediately preceding its formation. Allopurinol is a structural analogue of the natural purine base, hypoxanthine. It is an inhibitor of xanthine oxidase, the enzyme responsible for the conversion of hypoxanthine to xanthine and xanthine to uric acid, the end product of purine metabolism. Allopurinol is approximately 90% absorbed from the GI tract. Peak plasma levels generally occur at 1.5 hours to 4.5 hours. It has a plasma half life of about 1 to 2 hours. Approximately 20% of the ingested Allopurinol is excreted in the faeces.
","Adults: Allopurinol should be introduced at low dosage e.g. 100mg/day to reduce the risk of adverse reactions and increased only if the serum urate response is unsatisfactory. Extra caution should be exercised if renal function is poor. The following dosage schedules are suggested: 100 to 200 mg daily in mild conditions, 300 to 600 mg daily in moderately severe conditions, 700 to 900 mg daily in severe conditions.
Children: Children under 15 years: 10 to 20 mg/kg body weight/day up to a maximum of 400 mg daily. Use in children is rarely indicated, except in malignant conditions (especially leukaemia) and certain enzyme disorders such as Lesch-Nyhan syndrome.
Elderly: In the absence of specific data, the lowest dosage which produces satisfactory urate reduction should be used.
Dosage in renal impairment: In severe renal insufficiency, it may be advisable to use less than 100 mg per day or to use single doses of 100mg at longer intervals than one day.
",,"When 6-mercaptopurine or azathioprine is given concurrently with Allopurinol, only one-quarter of the usual dose of 6- mercaptopurine or azathioprine should be given because inhibition of xanthine oxidase will prolong their activity. Evidence suggests that the plasma half-life of vidarabine is increased in the presence of allopurinol. When the two products are used concomitantly extra vigilance is necessary, to recognise enhanced toxic effects. Theophylline levels should be monitored in patients starting or increasing allopurinol therapy. An increase in frequency of skin rash has been reported among patients receiving ampicillin or amoxicillin concurrently with allopurinol compared to patients who are not receiving both drugs. Reports suggest that the plasma concentration of ciclosporin may be increased during concomitant treatment with allopurinol.
","Allopurinol tablet is contra-indicated in patients with known hypersensitive to allopurinol.
","Rashes, gastro intestinal disorder’s, rearly malaise, headache, vertigo, drowsiness, visual and test disturbances, hypertension, alopecia, hepatotoxicity, neuropathy, gynaeconastia and blood disorders.
","There is inadequate evidence of safety of Allopurinol in human pregnancy. Use in pregnancy only when there is no safer alternative and when the disease itself carries risk for the mother or unborn child. There are no data concerning the effects of allopurinol or its metabolites on the breast-feed baby.
","Allopurinol should be withdrawn immediately when a skin rash or other evidence of sensitivity occurs. Reduced doses should be used in patients with hepatic or renal impairment. Patients under treatment for hypertension or cardiac insufficiency may have some concomitant impairment of renal function and allopurinol should be used with care in this group.
",,"Ingestion of up to 22.5 g allopurinol without adverse effect has been reported. Symptoms and signs including nausea, vomiting, diarrhoea and dizziness have been reported in a patient who ingested 20 gm allopurinol. Adequate hydration to maintain optimum diuresis facilitates excretion of allopurinol and its metabolites. If considered necessary haemodialysis may be used.
",,,"Store in a cool and dry place, protected from light.
",11
+2031,Allium cepa + Heparin + Allantoin,allium-cepa-heparin-allantoin-2031,,,,"This gel is indicated for the following scar treatment:
+
+- hypertrophic and keloid scars
+- scar that occurs after surgery
+- scar that occurs after amputation, burns and trauma
+- scar due to traumatic tendon contracture
+
",,"Extract of Allium cepa: It is derived from the membrane of Allium cepa (onion membrane). It shows antiphlogistic efects through inhibition of infammatory mediators’ secretion and anti-allergenic efect. Extract of Allium cepa inhibits growth of fbroblast of diferent origin, particularly kelloidal fbroblasts. It has also bactericidal efect. While these properties stimulate primary wound healing, it prevents non-physiological scar formation.
Heparin: In case of local application, it shows inhibitory efect on fbroblast proliferation. While heparin increases tissue hydration, it reduces irritation resulted from induration and infammation.
Allantoin: Allantoin stimulates cellular proliferation. It also supports the development of healthy cells. Allantoin is convenient substance for the treatment of scar through its properties of stimulating epithelization and providing elastic surface formation.
Clinical studies:
+
+- Evaluation of the use of Extract of Allium cepa, Heparin & Allantoin gel for the prevention of scar formation: Total 1,268 patients were evaluated and after 2 to 3 months of treatment with Extract of Allium cepa, Heparin & Allantoin gel, a reduction of 31.5% in mean scar width and 47.8% reduction of mean scar height at the end of the observation period.
+- Assessment of the use of Extract of Allium cepa, Allantoin, and Heparin in the early treatment of C-section scars: A total of 61 females, aged ≥18 years, who had given birth by C-section were evaluated. After six weeks of treatment, the gel showed signifcant improvement of the color, stifness and irregularity of C-section scars.
+
","This gel should be applied 3-4 times a day to the affected area and massaged gently in order to achieve better penetration. Continue with a circular motion until the gel is completely absorbed. Treatment may take several weeks or months depending on the size of existing scars and contracture.
This gel is very safe and its tolerability has been proven in numerous clinical studies. Small children and even babies can be treated safely.
",,"There is no known and reported drug interaction.
","This gel should not be used in patients with known hypersensitivity to any of its ingredients.
","This gel is generally well tolerated even in long-term use. In rare cases, some local irritations are reported such as slight erythema and itching. These side effects do not require discontinuation of the treatment.
","There are no studies conducted during pregnancy and lactation periods. Therefore it should be used with caution.
","During treatment of fresh scars with this preparation, excess cold, UV lights and abrupt massage should be avoided. Avoid contact with eyes, the inside of the nose or mouth and other mucous membranes.
",,,,,"Store in a cool and dry place, below 25°C. Protect from direct sunlight and moisture. Do not freeze. Keep the medicine out of the reach of children.
",9
+41,Alfuzosin Hydrochloride,alfuzosin-hydrochloride-41,https://medex.com.bd/attachments/IX9JcDOG2jbCxouxR0odP695MqQZhO/alfuzosin-hydrochloride-prescribing-information,BPH/ Urinary retention/ Urinary incontinence,Benign prostatic hyperplasia (BPH),"Alfuzosin Hydrochloride is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia(BPH), lower urinary tract symptoms (LUTS) including urinary frequency, nocturia, incomplete emptying and urinary hesitancy associated with BPH.
","BPH/ Urinary retention/ Urinary incontinence
","Alfuzosin Hydrochloride is a selective antagonist of post-synaptic a1 adrenoreceptors, which are located in the prostate, bladder base, bladder neck, prostatic capsule, and prostatic urethra. Alfuzosin Hydrochloride relaxes the tone of the prostate smooth muscle, prostate capsule, bladder neck and proximal urethra. It competitively and selectively binds to the post synaptic a1-adrenergic receptors in the lower urinary tract. It also relaxes sympathetic nervous stimulation, reduces resting urethral pressure and inhibits urethral hypertonia-induced sympathetic nervous stimulation. As an uroselective agent, Alfuzosin Hydrochloride preferentially binds to prostatic a1 receptors, blockage of these receptors result in reduction of BPH symptoms, improvement of urine flow and decreased potential for hypertensive events.
","Benign prostatic hyperplasia (BPH): The recommended dose is 10 mg to be taken once daily after a meal.
Acute urinary retention (AUR): In patients 65 years and older, 10 mg daily after a meal to be taken from the first day of catheterisation. The treatment should be administered for 3-4 days, 2-3 days during catheterisation and 1 day after its removal. In this indication no benefit has been established in patients under 65 years of age or if treatment is extended beyond 4 days.
","Alfuzosin Hydrochloride tablet should be swallowed whole.
","Combinations contra-indicated: Alpha-1-receptor blockers. Combinations to be taken into account: Antihypertensive drugs, nitrates, potent CYP3A4 inhibitors such as ketoconazole, itraconazole and ritonavir. Repeated 200mg daily dosing of ketoconazole, for seven days resulted in a 2.1-fold increase in Cmax and a 2.5-fold increase in exposure of Alfuzosin Hydrochloride 10mg when administered as a single dose under fed conditions (high fat meal). Other parameters such as tmax and t1/2 were not modified. Cmax and AUC of Alfuzosin Hydrochloride 10mg, when administered as a single dose under fed conditions, increased 2.3- fold and 3.0- fold, respectively following 8-day repeated 400mg ketoconazole daily dosing. The administration of general anaesthetics to patients receiving Alfuzosin Hydrochloride could cause profound hypotension. It is recommended that the tablets be withdrawn 24 hours before surgery.
Other forms of interaction: No pharmacodynamic or pharmacokinetic interaction has been observed in healthy volunteers between Alfuzosin Hydrochloride and the following drugs: warfarin, digoxin, hydrochlorothiazide and atenolol.
","As with all alpha-1-blockers in some subjects, in particular patients receiving antihypertensive medications or nitrates, postural hypotension with or without symptoms (dizziness, fatigue, sweating) may develop within a few hours following administration. In such cases, the patient should lie down until the symptoms have completely disappeared. These effects are transient, occur at the beginning of treatment and do not usually prevent the continuation of treatment. The patient should be warned of the possible occurrence of such events. As with all alpha1-receptor blockers, Alfuzosin Hydrochloride should be used with caution in patients with acute cardiac failure. Care should be taken when Alfuzosin Hydrochloride is administered to patients who have had a pronounced hypotensive response to another alpha-1-blocker. Treatment should be initiated gradually in patients with hypersensitivity to alpha-1-blockers. Alfuzosin Hydrochloride should be administered carefully to patients being treated with antihypertensives. Blood pressure should be monitored regularly, especially at the beginning of treatment. Patients with congenital QTc prolongation, with a known history of acquired QTc prolongation or who are taking drugs known to increase the QTc interval should be evaluated before and during the administration of Alfuzosin Hydrochloride. In coronary patients, the specific treatment for coronary insufficiency should be continued. If angina pectoris reappears or worsens Alfuzosin Hydrochloride should be discontinued. As there are no clinical safety data available in patients with severe renal impairment (creatinine clearance < 30ml/min), Alfuzosin Hydrochloride 10mg prolonged released tablets should not be administered to this patient group. Patients should be warned that the tablet should be swallowed whole. Any other mode of administration, such as crunching, crushing, chewing, grinding or pounding to powder should be prohibited. These actions may lead to inappropriate release and absorption of the drug and therefore possible early adverse reactions. The ‘Intraoperative Floppy Iris Syndrome’ (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with alpha-1-blockers. Although the risk of this event with Alfuzosin Hydrochloride appears very low, ophthalmic surgeons should be informed in advance of cataract surgery of current or past use of alpha-1-blockers, as IFIS may lead to increased procedural complications. The ophthalmologists should be prepared for possible modifications to their surgical technique. Alfuzosin Hydrochloride 10mg prolonged release tablets contain hydrogenated castor oil which may cause stomach upset and diarrhoea.
","Classification of expected frequencies: Very common (<1/10), common (<1/100 to <1/10), uncommon (<1/1,000 to <1/100), rare (<1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Nervous system disorders: Common: faintness/dizziness, headache; Uncommon: syncope, vertigo, malaise, drowsiness. Eye disorders: Uncommon: vision abnormal; Not known: intraoperative floppy iris syndrome. Cardiac disorders: Uncommon: tachycardia, palpitations, hypotension (postural); Very rare: New onset, aggravation or recurrence of angina pectoris in patients with pre-existing coronary artery disease; Not known: atrial fibrillation. Vascular disorders: Uncommon: hypotension (postural), flushing. Blood and lymphatic system disorders: Not known: neutropenia, thrombocytopenia. Respiratory, thoracic and mediastinal disorders: Uncommon: rhinitis. Gastro-intestinal disorders: Common: nausea, abdominal pain; Uncommon: diarrhoea, dry mouth, vomiting; Not known: vomiting. Hepatobiliary disorders: Frequency unknown: hepatocellular injury, cholestatic liver disease. Skin and subcutaneous tissue disorders: Uncommon: rash, pruritus; Very rare: urticaria, angioedema. Reproductive system and breast disorders: Frequency unknown: priapism. General disorders and administration site conditions: Common: asthenia; Uncommon: flushes, oedema, chest pain.
","Due to the type of indication this is not applicable.
","The administration of general anesthetics to patients receiving Alfuzosin could cause profound hypotension. It is recommended that the tablets be withdrawn 24 hours before surgery. If symptoms of angina pectoris start or get worse, taking Alfuzosin should be stopped.
","Paediatric Population: Efficacy of Alfuzosin Hydrochloride has not been demonstrated in children aged 2 to 16 years. Therefore Alfuzosin Hydrochloride is not indicated for use in the paediatric population.
","In case of overdosage, the patient should be hospitalised, kept in the supine position, and conventional treatment of hypotension should take place. In case of significant hypotension, the appropriate corrective treatment may be a vasoconstrictor that acts directly on vascular muscle fibres.
",,,"Store in a cool and dry place, protected from light
",13
+40,Alfacalcidol,alfacalcidol-40,https://medex.com.bd/attachments/h3o4MXIL7l4dvCEhxEPS2xGLMADC7J/alfacalcidol-prescribing-information,Vitamin in bone formation,Rickets,"Alfacalcidol is indicated in:
+
+- It is used to increase the amount of vitamin D in your body. This often increases calcium levels as well which can help in treatment of certain illnesses.
+- In general this drug is used to treat diseases where the amount of calcium and phosphate (which is controlled by the level of vitamin D) in your body needs changing.
... Read more
Alfacalcidol is indicated in:
+
+- It is used to increase the amount of vitamin D in your body. This often increases calcium levels as well which can help in treatment of certain illnesses.
+- In general this drug is used to treat diseases where the amount of calcium and phosphate (which is controlled by the level of vitamin D) in your body needs changing.
+- Benefits of being on this drug can include control of the levels of calcium and phosphate in your body.
+- Treat and prevent bone conditions that are caused by kidney failure (osteodystrophy)
+- Treat illnesses and abnormalities affecting the parathyroid glands which make a substance called the parathyroid hormone.
+- Correct low levels of calcium in the blood of newborn babies (hypocalcaemia)
+- Treat the softening and deformity of the bones due to lack of calcium (rickets or osteomalacia)
+
","Vitamin in bone formation, Vitamin-D preparations
","The first step involved in the activation of vitamin D3 is a 25-hydroxylation which is catalysed by the 25-hydroxylase in the liver and then by other enzymes. The mitochondrial sterol 27-hydroxylase catalyses the first reaction in the oxidation of the side chain of sterol intermediates. The active form of vitamin D3 (calcitriol) binds to intracellular receptors that then function as transcription factors to modulate gene expression. Like the receptors for other steroid hormones and thyroid hormones, the vitamin D receptor has hormone-binding and DNA-binding domains. The vitamin D receptor forms a complex with another intracellular receptor, the retinoid-X receptor, and that heterodimer is what binds to DNA. In most cases studied, the effect is to activate transcription, but situations are also known in which vitamin D suppresses transcription. Calcitriol increases the serum calcium concentrations by: increasing GI absorption of phosphorus and calcium, increasing osteoclastic resorption, and increasing distal renal tubular reabsorption of calcium. Calcitriol appears to promote intestinal absorption of calcium through binding to the vitamin D receptor in the mucosal cytoplasm of the intestine. Subsequently, calcium is absorbed through formation of a calcium-binding protein.
","Adults: The usual starting dose is 1 microgram each day. People usually take between 1 and 3 micrograms each day. Most people take between 0.25 and 1 microgram each day once the blood test results show the medicine is working.
If you have very low levels of calcium in your blood, your doctor may prescribe between 3 and 5 microgram each day. Your doctor may prescribe another medicine called a calcium supplement to take as well as Alfacalcidol. This will help to keep the right amount of calcium level in your blood.
Elderly: The usual starting dose is 0.5 microgram each day.
Children:
+
+- Newborn and premature babies: The usual starting dose is 0.05 to 0.1 microgram per kilogram of body weight each day. If the level of calcium in their blood is very low, up to 2 micrograms per kilogram of body weight may be needed each day. A dose of 0.1 microgram per kilogram body weight each day is used to stop low blood calcium levels in premature babies.
+- Children weighing less than 20 kilograms: The usual starting dose is 0.05 microgram per kilogram body weight each day.
+- Children weighing more than 20 kilograms: The usual starting dose is 1 microgram each day.
+
","Should be taken with food.
","Thiazides may increase the risk of hypercalcaemia. Some antiepileptics e.g. carbamazepine, phenobarbital, phenytoin and primidone may increase vitamin D requirements. Rifampicin, isoniazid and corticosteroids may reduce the efficacy of vitamin D.
","Hypercalcaemia, metastatic calcification, hyperphosphataemia (except when occurring with hypoparathyroidism), hypermagnesaemia.
","Anorexia, nausea, vomiting, diarrhoea, lassitude, polyuria, sweating, headache, thirst, vertigo, pruritus, rash, urticaria. Hypercalcaemia, hypercalciuria and ectopic calcification.
In case of renal impairment, hyperphosphataemia. In hypercalcaemic dialysis patients, possibility of calcium influx from the dialysate should be considered.
","FDA has not yet classified the drug into a specified pregnancy category.
","Pregnancy, lactation, renal impairment, infants, elderly. Monitor serum levels of calcium in patients with renal failure. Caution in hypercalciuria in those with history of renal calculi. Avoid in patients with hypersensitivity to inj. containing propylene glycol.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+37,Alendronic Acid + Vitamin D3,alendronic-acid-vitamin-d3-37,https://medex.com.bd/attachments/OTqqzJTNS2ANMU2hgVa36oxNOgzYKF/alendronic-acid-vitamin-d3-prescribing-information,Combined preparations: Inhibiting bone resorption,Post-menopausal osteoporosis,"Alendronic Acid & Vitamin D3 is indicated in:
+
+- Treatment of osteoporosis in postmenopausal women.
+- Treatment of osteoporosis in men.
+- Treatment of osteoporosis as it increases the bone mass and reduces the incidence of fractures, including those of the hip and spine.
+
","Combined preparations: Inhibiting bone resorption
","Alendronate Sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast mediated bone resorption. Alendronate is effective when administered at least 30 minutes before breakfast. It transiently distributes to soft tissues following administration but is then rapidly distributed to bone or excreted in the urine. Protein binding in human plasma is approximately 78%. There is no evidence that Alendronate is metabolised in animals or humans. At the cellular level, Alendronate shows preferential localization to sites of bone resorption, specially under osteoclasts. It inhibits osteoclast activity. In addition, bone formation exceeds bone resorption, leading to progressive gains in bone mass. Vitamin D is required for normal bone formation. Vitamin D insufficiency develops when both sunlight exposure and dietary intake are inadequate. Insufficiency is associated with negative calcium balance, increased parathyroid hormone levels, bone loss, and increased risk of skeletal fracture.
","Treatment of Osteoporosis in Postmenopausal Women: The recommended dosage is-
+
+- 70 mg alendronate and 2800 IU vitamin D3 or
+- 70 mg alendronate and 5600 IU vitamin D3 tablet once weekly.
+- For most osteoporotic women, the appropriate dose is 70 mg alendronate and 5600 IU vitamin D3 once weekly.
+
+Treatment to Increase Bone Mass in Men with Osteoporosis: The recommended dosage is-
+
+- 70 mg alendronate and 2800 IU vitamin D3 or
+- 70 mg alendronate and 5600 IU D3 tablet once weekly.
+- For most osteoporotic men, the appropriate dose is 70 mg alendronate and 5600 IU vitamin D3 once weekly.
+
","To permit adequate absorption, Alendronate & Colecalciferol must be taken at least 30 minutes before the first food, beverage or medication of the day with plain water only. Other beverages (including mineral water), food and some medications are likely to reduce the absorption of Alendronate. To facilitate delivery to the stomach and thus to reduce the potential for esophageal irritation, Alendronate & Colecalciferol tablet should only be swallowed upon rising for the day with a full glass of water. Patients should not lie down for at least 30 minutes after taking Alendronate until after their first food of the day. Alendronate & Colecalciferol should not be taken at bed time.
","Calcium supplement, antacids and some oral medications will interfere with absorption of Alendronate if taken at the same time. Intravenous ranitidine makes the bioavailability of oral Alendronate double. Incidence of upper gastro-intestinal adverse events associated with NSAID and aspirin appears to be greater with concomitant administration of Alendronate. Mineral oils, orlistat, and bile acid sequestrants (e.g., cholestyramine, colestipol) may impair the absorption of vitamin D. Anticonvulsants, cimetidine, and thiazides may increase the catabolism of vitamin D.
","
+- Abnormalities of the esophagus which delay esophageal emptying, such as stricture or achalasia.
+- Inability to stand or sit upright for at least 30 minutes.
+- Hypersensitivity to any component of this product.
+- Hypocalcaemia.
+
","Usually mild and generally do not require discontinuation of therapy. Side effects include esophageal reactions, abdominal pain and distension, diarrhoea or constipation, flatulence, musculoskeletal pain, headache, rash, erythema and transient decreases in serum calcium and phosphate.
","Pregnancy category C. Overdoses of vitamin D have shown teratogenic effects in pregnant animals. Alendronic Acid & Vitamin D3 (Colecalciferol) should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus. Cholecalciferol and some of its active metabolites pass into breast milk. It is not known whether alendronate is excreted in human milk. Caution should be exercised when administered to lactating women.
","Hypocalcaemia and other disturbances of mineral metabolism should be corrected before initiation of therapy. Alendronate can cause local irritation of the upper gastro-intestinal mucosa. Caution should be used when Alendronate is given to patients with active upper gastrointestinal problems such as dysphagia, esophageal disease, gastritis, duodenitis or ulcers. Patients should stop taking medicine and consult their physician if they develop esophageal diseases.
","Dosing in elderly and renal insufficiency: No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 mL/min). Alendronic Acid + Vitamin D3 (Colecalciferol) is not recommended for patients with more severe renal insufficiency (creatinine clearance<35 mL/min) due to lack of experience.
","Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer, may result from oral overdosage. Signs and symptoms of vitamin D toxicity include hypercalcemia, hypercalciuria, anorexia, nausea, vomiting, polyuria, polydipsia, weakness, and lethargy.
",,,"Store in a cool and dry place. Protect from light & moisture. Keep out of the reach of children.
",13
+30,Alendronic acid,alendronic-acid-30,https://medex.com.bd/attachments/9kjN4ASl1jT97Pdo3ZEDF7C0YDbVs3/alendronic-acid-prescribing-information,Bisphosphonate preparations,Post-menopausal osteoporosis,"Alendronic acid is indicated for the-
+
+- Treatment of Osteoporosis in Postmenopausal Women: Alendronic acid is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, Alendronic acid increases bone mass and reduces the incidence of fractures, including those of the hip and spine.
... Read more
Alendronic acid is indicated for the-
+
+- Treatment of Osteoporosis in Postmenopausal Women: Alendronic acid is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, Alendronic acid increases bone mass and reduces the incidence of fractures, including those of the hip and spine.
+- Prevention of Osteoporosis in Postmenopausal Women: Alendronic acid is indicated for the prevention of postmenopausal osteoporosis.
+- Treatment to Increase Bone Mass in Men with Osteoporosis: Alendronic acid is indicated for treatment to increase bone mass in men with osteoporosis.
+- Treatment of Glucocorticoid-Induced Osteoporosis: Alendronic acid is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density.
+- Treatment of Paget's Disease of Bone: Alendronic acid is indicated for the treatment of Paget’s disease of bone in men and women. Treatment is indicated in patients with Paget's disease of bone who have alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease.
+
","Bisphosphonate preparations
","Alendronate is a bisphosphonate that binds to bone hydroxyapatite and specifically inhibits the activity of osteoclasts, the bone-resorbing cells. Alendronate reduces bone resorption with no direct effect on bone formation, although the latter process is ultimately reduced because bone resorption and formation are coupled during bone turnover.
Animal studies have indicated the following mode of action. At the cellular level, alendronate shows preferential localization to sites of bone resorption, specifically under osteoclasts. The osteoclasts adhere normally to the bone surface but lack the ruffled border that is indicative of active resorption. Alendronate does not interfere with osteoclast recruitment or attachment, but it does inhibit osteoclast activity. Studies in mice on the localization of radioactive [3H] alendronate in bone showed about 10-fold higher uptake on osteoclast surfaces than on osteoblast surfaces. Bones examined 6 and 49 days after [3H] alendronate administration in rats and mice, respectively, showed that normal bone was formed on top of the alendronate, which was incorporated inside the matrix. While incorporated in bone matrix, alendronate is not pharmacologically active. Thus, alendronate must be continuously administered to suppress osteoclasts on newly formed resorption surfaces. Histomorphometry in baboons and rats showed that alendronate treatment reduces bone turnover (i.e., the number of sites at which bone is remodeled). In addition, bone formation exceeds bone resorption at these remodeling sites, leading to progressive gains in bone mass.
","Treatment of Osteoporosis in Postmenopausal Women: The recommended dosage is one 70 mg tablet once weekly or one bottle of 70 mg oral solution once weekly or one 10 mg tablet once daily.
Prevention of Osteoporosis in Postmenopausal Women: The recommended dosage is one 35 mg tablet once weekly or one 5 mg tablet once daily.
Treatment to Increase Bone Mass in Men with Osteoporosis: The recommended dosage is one 70 mg tablet once weekly or one bottle of 70 mg oral solution once weekly or one 10 mg tablet once daily.
Treatment of Glucocorticoid-Induced Osteoporosis: The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.
Treatment of Paget's Disease of Bone: The recommended treatment regimen is 40 mg once a day for six months.
",,"The incidence of upper gastrointestinal side effects are increased with the concomitant use of non-steroidal anti-inflammatory agents and aspirin. Absorption of Alendronate is reduced in the presence of antacids and calcium supplements.
","Alendronic acid is contraindicated in patients with the following conditions:
+
+- Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia.
+- Inability to stand or sit upright for at least 30 minutes.
+- Do not administer Alendronic acid oral solution to patients at increased risk of aspiration.
+- Hypocalcemia.
+- Hypersensitivity to any component of this product. Hypersensitivity reactions including urticaria and angioedema have been reported.
+
","The commonest symptomatic side effects are constipation, diarrhoea, oesophageal ulcer, flatulence, dysphagia, musculoskeletal pain, headache, rarely rash, erythema, transient decrease in serum calcium and phosphate, nausea, vomiting, peptic ulceration, hypersensitivity reactions including urticaria and angio-oedema.
","Alendronic acid should not be given to pregnant women or nursing mother.
","
+- Upper Gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions. Discontinue if new or worsening symptoms occur.
+- Hypocalcemia can worsen and must be corrected prior to use.
+- Severe Bone, Joint, Muscle Pain may occur. Discontinue use if severe symptoms develop.
+- Osteonecrosis of the Jaw has been reported.
+- Atypical Femur Fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out an incomplete femoral fracture.
+
","Pediatric Use: Alendronic acid is not indicated for use in pediatric patients.
Renal Impairment: Alendronic acid is not recommended for patients with creatinine clearance less than 35 mL/min. No dosage adjustment is necessary in patients with creatinine clearance values between 35-60 mL/min.
Hepatic Impairment: As there is evidence that alendronate is not metabolized or excreted in the bile, no studies were conducted in patients with hepatic impairment. No dosage adjustment is necessary.
",,,,"Store in a well-closed container at room temperature, 15-30°C
",11
+1501,Alectinib,alectinib-1501,,Protein kinase inhibitor,Metastatic non-small cell lung cancer,"Alectinib indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
","Anti neoplastic preparations, Protein kinase inhibitor
","Alectinib is a highly selective and potent ALK and RET tyrosine kinase inhibitor.In nonclinicalstudies, inhibition of ALK tyrosine kinase activity led to blockage of downstream signaling pathways including STAT 3 and PI3K/AKT and inducedtumor cell death (apoptosis).
Alectinib demonstratedin vitroand in vivoactivity against mutant forms of the ALK enzyme, including mutations responsible forresistance to crizotinib.The major metabolite of alectinib (M4) has shown similar in vitropotency and activity.
Based on nonclinicaldata, alectinib is not a substrate of p-glycoprotein (P-gp) or breast cancer resistance protein (BCRP), which are both efflux transporters in the blood brain barrier, and is therefore able to distribute into and be retained within the central nervous system. Alectinibinducedtumor regressionin nonclinicalmousexenograft models, including antitumor activity in the brain, and prolonged survival inintracranial tumor animal models.
","The recommended dose of Alectinib is 600 mg (four 150 mg capsules) given orally, twice daily (total daily dose of 1200 mg). Patients with underlying severe hepatic impairment should receive a dose of 450 mg given orally twice daily (total daily dose of 900 mg). Alectinib hard capsules should be taken with food, swallowed whole and must not be opened or dissolved.
","Duration of Treatment: It is recommended that patients are treated with Alectinib until disease progression or unmanageable toxicity.
Dose Modifications: Management of adverse events may require temporary interruption, dosereduction, or discontinuation of treatment with Alectinib. The dose of Alectinib should be reduced in steps of 150 mg twice daily based on tolerability. Alectinib treatment should be permanently discontinued if patients are unable to tolerate the 300 mg twice-daily dose.
","In vitro studies indicate that neither alectinib nor its major active metabolite (M4) inhibits CYP1A2, CYP2B6, CYP2C9, CYP2C19, or CYP2D6 at clinically relevant concentrations. Alectinib and M4 show weak time-dependent inhibition of CYP3A4. In vitro, alectinib exhibits a weak induction potential of CYP3A4 and CYP2B6 at clinical concentrations. Results from a clinical drug-drug interaction study in ALK-positive NSCLC patients demonstrated that multiple doses of alectinib had no influence on the exposure of midazolam, a sensitive CYP3A substrate. Therefore, no dose adjustment is required for co-administered CYP3A substrates. Although in vitro studies indicate that alectinib is an inhibitor of CYP2C8, physiologically based pharmacokinetic (PBPK) modeling supports that at clinically relevant concentrations alectinib does not have the potential to increase plasma concentrations of co-administered substrates of CYP2C8.
","Alectinib is contraindicated in patients with a known hypersensitivity to alectinib or any of the excipients.
","The most common adverse drug reactions were constipation, edema including peripheral, generalized, eyelid, periorbital; myalgia (31% including myalgia and musculoskeletal pain), nausea, increased bilirubin (21% including increased blood bilirubin, hyperbilirubinemia and increased bilirubin conjugated), anemia (20%, including anemia and hemoglobin decreased), and rash (20%, including rash, rash maculopapular, dermatitis acneiform, erythema, rash generalized, rash papular, rash pruritic and rash macular).
","Pregnancy: Women of childbearing potential must be advised to avoid pregnancy while on Alectinib. No clinical studies of Alectinib in pregnant women have been performed. Based on its mechanism of action, Alectinib may cause fetal harm when administered to a pregnant woman. Female patients or women who are partners of male patients receiving Alectinib, who become pregnant while taking Alectinib or during the 3 months following the last dose of Alectinib must contact their doctor and should be advised of the potential harm to the fetus.
Lactation: It is not known whether Alectinib is excreted in human breast milk. No studies have been conducted to assess the impact of Alectinib on milk production or its presence in breast milk. As many drugs are excreted in human milk and because of the potential harm to the infant, mothers should be advised against breastfeeding while receiving Alectinib.
Contraception: Female patients of child-bearing potential, or women of child-bearing potential who are partners of male patients receiving Alectinib, must use highly effective contraceptive methods during treatment and for at least 3 months following the last dose of Alectinib
","Interstitial lung disease (ILD)/pneumonitis: Cases of ILD/pneumonitishave been reported in clinical trials with Alectinib. Patients should be monitored for pulmonary symptoms indicative of pneumonitis. Alectinib should be immediately interrupted in patients diagnosed with ILD/pneumonitis and should be permanently discontinued if no other potential causes of ILD/pneumonitis have been identified
Hepatotoxicity: Elevations in alanine amino transferase (ALT) and aspartate amino transferase (AST) greater than 5 times the upper limit of normal (ULN) as well as bilirubin elevations of more than 3 times the ULN occurred in patients in pivotal clinical trials with Alectinib. The majority of these events occurred during the first 3months of treatment. In the pivotal Alectinib clinical trials it was reported that three patients with Grade 3‒4 AST/ALT elevations had drug-induced liver injury. Concurrent elevations in ALT or AST greater than or equal to three times the ULN and total bilirubin greater than or equal to two times the ULN, with normal alkaline phosphatase, occurred in 1 patient treated in Alectinib clinical trials.
","Pediatric use: The safety and efficacy of alectinib in children and adolescents (<18 years) have not been studied.
Geriatric use: No dose adjustment of alectinib is required in patients≥65 years of age.
Renal impairment: No dose adjustment is required in patients with mild or moderate renal impairment. alectinib has not been studied in patients with severe renal impairment, however,since alectinib elimination via the kidney is negligible, no dose adjustment is required inpatients with severe renal impairment
Hepatic impairment: No dose adjustment is required in patients with underlying mild or moderate hepatic impairment. Patients with underlying severe hepatic impairment should receive a dose of 450 mg given orally twice daily (total daily dose of 900 mg)
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+29,Alcaftadine,alcaftadine-29,https://medex.com.bd/attachments/MXJvr3fMHAZ5uWsqOR8p0vS0Ptuale/alcaftadine-prescribing-information,Ophthalmic Anti-allergic preparations,Prevention of itching associated with allergic conjunctivitis,"Alcaftadine eye drops is indicated for the prevention of itching associated with allergic conjunctivitis. Alcaftadine ophthalmic solution is an H1 receptor antagonist, in a sterile ophthalmic solution for topical ophthalmic use.
","Ophthalmic Anti-allergic preparations
","This eye drops is a sterile topical ophthalmic solution containing Alcaftadine. Alcaftadine is an histamine receptor antagonist and inhibitor of the release of histamine from mast cell. It is also a potent histamine H2 and H4 receptor antagonist that has demonstrated anti-inflammatory property. In doing so, antihistaminic effect provides relief from itching associated with early phase of ocular allergic response, whereas mast cell stabilization inhibits the release of mediators such as cytokines and lipid mediators that play a role in late-phase response of allergic conjunctivitis.
","Adults and children 2 years and over: Instill one drop in each eye once daily.
",,,"Alcaftadine is contraindicated in patients with hypersensitivity to any component in the product.
","The most frequent ocular reactions are eye irritation, burning or/and stinging upon instillation, eye redness and eye pruritus, nasopharyngitis and headache.
","Pregnancy category B. There are however, no adequate and well controlled studies in pregnant women, thus this drug should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Caution should be exercised while administered to a nursing woman.
","To minimize eye injury and contamination of the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Patients should be advised not to wear a contact lens if their eye is red. This preparation should not be used to treat contact lens related irritation and should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation this preparation. Lenses may be reinserted after 10 minutes following administration. If more than 1 topical ophthalmic medicinal product is being used, each one should be administered at least 5 minutes apart.
","Pediatric Use: Safety and effectiveness in pediatric patients below the age of 2 years have not been established.
Geriatric Use: No overall differences in safety or effectiveness were observed between elderly and younger subjects.
",,,,"Store in a cool (15°C - 25°C) and dry place protected from light. Do not use after one month once the cap is opened.
",10
+545,Albumin (Human),albumin-human-545,https://medex.com.bd/attachments/w4pOZpgGfz8WYTd35z8FLF8geIDHk7/albumin-human-25-prescribing-information,Plasma expanders,Hypoproteinaemia,"Shock: Albumin is indicated in the emergency treatment of shock and in other similar conditions where the restoration of blood volume is urgent. If there has been considerable loss of red blood cells, transfusion with packed red blood cells is indicated.
... Read more
Shock: Albumin is indicated in the emergency treatment of shock and in other similar conditions where the restoration of blood volume is urgent. If there has been considerable loss of red blood cells, transfusion with packed red blood cells is indicated.
Burns: Albumin or Albumin in either normal saline or dextrose is indicated to prevent marked hemoconcentration and to maintain appropriate electrolyte balance.
Hypoproteinemia with or without edema: Albumin is indicated in those clinical situations usually associated with a low concentration of plasma protein and a resulting decreased circulating blood volume. Although diuresis may occur soon after albumin administration has been instituted, best results are obtained if albumin is continued until the normal serum protein level is regained.
","Plasma expanders
","The main function of albumin results from its contribution to plasma colloid oncotic pressure and transport function. Albumin stabilizes circulating blood volume and carries hormones, enzymes, medicines, and toxins. Other physiological functions include antioxidant properties, free radical scavenging, in addition to maintenance capillary membrane integrity. Exogenously administered albumin increases the oncotic pressure of the intravascular system, moving fluids from the interstitial space, thereby decreasing edema and increasing the circulating blood volume. The increase in volume reduces the concentration and viscosity of blood in patients with decreased circulating blood volume while maintaining cardiac output in shock. In dehydrated patients, negligible effects exist on circulating blood volume. In addition to the above albumin replaces protein in patients with hypoproteinemia until the cause of the deficiency can be determined.
This drug has thousands of endogenous and exogenous targets. Human albumin also binds and carries a plethora of hydrophobic molecules, such as endogenous (i.e., cholesterol, fatty acids, bilirubin, thyroxine) or exogenous substances (for example, drugs and toxins), transition metal ions, as well as gas (nitric oxide [NO]), with resulting implications for their solubilisation, transport, metabolism, and detoxification.
","Human albumin 25% is for intravenous administration only. Human albumin may be diluted with 5% glucose or 0.9% sodium chloride. Concentration, dosage, and infusion-rate should be adjusted to the patient’s individual requirements and indication.
+
+- Hypovolemia: Initial dose 25 g is suggested.
+- Hypoalbuminemia: 50-75 gm
+- Prevention of central volume fluid removed depletion after
+- paracentesis due to cirrhotic ascites: 6-8 gm for every 1000 mL of ascitic.
+- OHSS: 50 to 100 gm over 4 hours and repeated at 4-12 hour intervals as necessary. 10-50 gm; single infusion.
+- ARDS: 25 g over 30 minutes and repeated at 8 hours for 3 days if necessary.
+- Burns: Determined by direct observation of vital sign or measurement of either plasma oncotic pressure or protein content.
+
+
Human albumin 20%: Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required. If human albumin is to be administered, haemodynamic performance should be monitored regularly; this may include:
+
+- arterial blood pressure and pulse rate
+- central venous pressure
+- pulmonary artery wedge pressure
+- urine output
+- electrolyte
+- haematocrit / haemoglobin
+
+The solution can be directly administered by the intravenous route, or it can be diluted in an isotonic solution (e.g. 0.9% sodium chloride). In plasma exchange the infusion rate should be adjusted to the rate of removal.
Human albumin 5% may be given intravenously without further dilution. This concentration is approximately isotonic and iso-osmotic with citrated plasma. Albumin (Human) in this concentration provides additional fluid for plasma volume expansion. Therefore, when it is administered to patients with normal blood volume, the rate of infusion should be slow enough to prevent too rapid expansion of plasma volume.
In the treatment of shock in an adult patient an initial dose of 500 mL of the 5% albumin solution is given as rapidly as tolerated. If response within 30 minutes is inadequate, an additional 500 mL of 5% albumin solution may be given. The 50 mL dosage form would be appropriate for pediatric use, with a dose of 10-20 mL per kg of body weight infused intravenously at a rate up to 5-10 mL per minute. Therapy should be guided by the clinical response, blood pressure and an assessment of relative anemia. If more than 1000 mL are given, or if hemorrhage has occurred, the administration of packed red blood cells may be desirable.
In severe burns, immediate therapy should include large volumes of crystalloid with lesser amounts of 5% albumin solution to maintain an adequate plasma volume. After the first 24 hours, the ratio of albumin to crystalloid may be increased to establish and maintain a plasma albumin level of about 2.5 g/100 mL or a total serum protein level of about 5.2 g/100 mL. However, an optimal regimen for the use of colloids, electrolytes and water after severe burns has not been established.
The infusion of Albumin (Human) as a nutrient in the treatment of chronic hypoproteinemia is not recommended. In acute hypoproteinemia, 5% albumin may be used in replacing the protein lost in hypoproteinemic conditions. However, if edema is present or if large amounts of albumin are lost, Albumin (Human) 25% is preferred because of the greater amount of protein in the concentrated solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
",,"Albumin solution should not be mixed by protein hydrolysates or alcoholic solutions. Risk of atypical reactions to ACE inhibitors in patients undergoing therapeutic plasma exchange with albumin human replacement.
","Albumin (Human) may be contraindicated in patients with severe anemia or cardiac failure and in patients with a history of allergic reactions to human albumin.
","Allergic or pyrogenic reactions are characterized primarily by fever and chills; rash, nausea, vomiting, tachycardia and hypotension have also been reported. Should an adverse reaction occur, slow or stop the infusion for a period of time which may result in the disappearance of the symptoms. If administration has been stopped and the patient requires additional Albumin (Human), material from a different lot should be used. Albumin (Human), particularly if administered rapidly, may result in vascular overload with resultant pulmonary edema.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Hypertension or low cardiac reserve; additional fluids for dehydrated patients. Monitor for signs of cardiac overload in injured or postoperative patients. May carry risk of viral transmission. Volume admin and rate of infusion must always be individualised according to situation and response. Pregnancy, lactation.
","No clinical studies using Albumin (Human) have been conducted in pediatric patients. Safety and effectiveness in pediatric patients have not been established. However, extensive experience in patients suggests that children respond to Albumin (Human) in the same manner as adults.
",,,,"Store below 30°C. Do not freeze.
",11
+16,Albendazole,albendazole-16,https://medex.com.bd/attachments/kB03SRJUqB0tOoHsDjkz23r4hhuO28/albendazole-prescribing-information,Anthelmintic,Worm infections,"Albendazole is indicated in single and mixed infestations of-
+
+- Hookworm (Ancylostoma, Necator)
+- Roundworm (Ascaris)
+- Threadworm (Enterobius)
+- Whipworm (Trichuris)
+- Strongyloides
+- Tapeworm
+- Opisthorchi
+- Hydatid.
+
","Anthelmintic
","Albendazole is a broad spectrum anthelmintic. Albendazole exhibits vermicidal, ovicidal and larvicidal activities. The drug is thought to exert its anthelmintic effect by blocking glucose uptake in the susceptible helminths, thereby depleting the energy level until it becomes inadequate for survival. Immobilization is followed by the parasite. These events may be a consequence of the binding and subsequent inhibition of parasite tubulin polymerization by Albendazole and its metabolites, although the drug also binds to human tubulin. Albendazole is extensively metabolized, probably in the liver. Albendazole is poorly absorbed from the gastrointestinal tract but rapidly undergoes extensive first-pass metabolism. The principal metabolite albendazole sulphoxide has anthelmintic activity and a plasma half-life of about 8.5 hrs. It is excreted in the urine together with other metabolites.
","Adults & children over 2 years:
+
+- 400 mg (1 tablet or 10 ml suspension) as a single dose in cases of Enterobius vermicularis, Trichuris trichiura, Ascaris lumbricoides, Ancylostoma duodenale and Necator americanus.
+- In cases of strongyloidiasis or taeniasis, 400 mg (1 tablet or 10 ml suspension) daily should be given for 3 consecutive days. If the patient is not cured on follow-up after three weeks, a second course of treatment is indicated.
+
+
Children of 1-2 years: Recommended dose is a single dose of 200 mg (5 ml suspension).
Children under 1 year: Not recommended.
In Hydatid disease (Echinococcosis):
+
+- Albendazole is given by mouth with meals in a dose of 400 mg twice daily for 28 days for patients weighing over 60 kg.
+- A dose of 15 mg/kg body weight daily in two divided doses (to a maximum total daily dose of 800 mg) is used for patients weighing less than 60 kg.
+- For cystic echinococcosis, the 28 days course may be repeated after 14 days without treatment, to a total of 3 treatment cycles.
+- For alveolar echinococcosis, cycles of 28 days of treatment followed by 14 days without treatment, may need to continue for months or years.
+- In giardiasis, 400 mg (1 tablet or 10 ml suspension) once daily for five days is used.
+
",,"No interaction involving Albendazole, either pharmacodynamic or pharmacokinetic, has been reported.
","Neonates: Albendazole is not normally used in neonates.
Children: Reduction of the dose from 400 mg to 200 mg may be indicated in children weighing less than 10 kg but there are no grounds for a general reduction in dosage to children.
Pregnant woman: Albendazole should not be given during pregnancy or women thought to be pregnant. No information is available on placental transfer.
Concurrent disease: There is no evidence to suggest that dose should be altered in renal, hepatic or cardiac failure.
","Gastrointestinal disturbances, headache, dizziness, changes in liver enzymes, rarely reversible alopecia; rash, fever, blood disorders including leucopenia and pancytopenia reported; allergic shock if cyst leakage; convulsion and meningism in cerebral disease.
","US FDA Pregnancy category of Albendazole is C. So, Albendazole should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
","Blood counts and liver function tests before treatment and twice during each cycle; breastfeeding; exclude pregnancy before starting treatment. Albendazole should only be used in the treatment of Echinococcosis if there is constant medical supervision with regular monitoring of serum-transaminase concentrations and of leucocyte and platelet counts
",,,,,"Keep in a dry place, away from light and heat. Keep out of the reach of children.
",10
+35,Agomelatine,agomelatine-35,https://medex.com.bd/attachments/v5y9lQL74Q596bL9BZGegnMQZF60NT/agomelatine-prescribing-information,Atypical anti-depressant drugs,Migraine,"Agomelatine is indicated for:
+
+- Major depressive disorder especially in non-responders and intolerant to SSRIs
+- Generalized anxiety disorder
+- Bipolar depression
+- Sleep disturbances
+- Seasonal affective disorder
+- Migraine and cluster headaches
+
","Atypical anti-depressant drugs
","This compound binds to the melatoninergic receptors and the serotoninergic 5-HT2c receptor giving rise to the Melatonin Agonist and Selective Serotonin Antagonist (MASSA) concept. The melatoninergic receptors MT1 and MT2, are G protein coupled receptors and they act through decreasing cAMP and cGMP. Agomelatine strongly binds to and stimulates the activity of MT1 and MT2 receptors normalizing the disturbed circadian rhythms and disrupted sleep-wake cycles. Unlike the existing antidepressants, agomelatine does not inhibit the uptake of serotonin, norepinephrine or dopamine. It inhibits 5HT-2C receptor (G protein coupled receptor which increases IP3/DAG secondary messenger system) found abundantly in the SCN, frontal cortex, hippocampus and basal ganglia involved in the mood, motor and cognitive deficits associated with depressive states. 5HT-2C receptor antagonism increases norepinephrine and dopamine levels in the frontal cortex of the brain. This action of agomelatine produces antidepressant, antianxiety and also increases slow-wave sleep which is decreased in depression. It has been observed that it can increase neurogenesis in the hippocampus and may also have neuroprotective effects (by influencing glutamate release, glucocorticoid receptor gene expression and various neurotropic factors) which might also contribute to its antidepressant effects. A study has shown that agomelatine alleviates sleep disturbances after one week of therapy and by two weeks antidepressant effects manifest. The combined actions of agomelatine at MT1, MT2, and 5HT-2C receptors can improve the disturbed circadian rhythm and abnormal sleep pattern thus produce the antidepressant effect. These unique effects suggest that it might be effective for the treatment of seasonal affective disorder like anxiety and bipolar depression.
","The effective dose of agomelatine is 25 mg per day given once at bed time for two weeks and can be increased to 50 mg per day in patients with inadequate response. Night time dosing is recommended because agomelatine improves the quality of sleep without day time sedation.
","For oral administration with or without food. Most adult patients should take a dosage of 25 mg (one tablet) daily. It is usually taking prior to bed time. If no improvement is noticed after two weeks, the dosage can be increased to 50 mg (two tablets) daily.
","Potential interactions affecting agomelatine: Agomelatine is metabolised mainly by cytochrome P450 1A2 (CYP1A2) (90%) and by CYP2C9 (10%). Medicinal products that interact with these isoenzymes may decrease or increase the bioavailability of agomelatine. Fluvoxamine, a potent CYP1A2 and moderate CYP2C9 inhibitor markedly inhibits the metabolism of agomelatine resulting in a 60-fold (range 12-412) increase of agomelatine exposure. Consequently, co-administration of agomelatine with potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) is contraindicated.
","It is contraindicated in patients with hepatic impairment and hypersensitivity to the active substances or any of the excipients.
","The commonly reported adverse effects in the clinical trials of agomelatine are headache, nausea and diarrhea.
","For agomelatine, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see Toxicology: Preclinical Safety Data under Actions). Caution should be exercised when prescribing to pregnant women. It is not known whether Agomelatine is excreted into human milk. agomelatine or its metabolites are excreted in the milk of lactating rats. Potential effects of agomelatine on the breastfeeding infant have not been established. If treatment with agomelatine is considered necessary, breastfeeding should be discontinued.
","It is found to increase the level of liver enzymes and so monitoring of enzyme level is warranted before starting therapy and therefore every 6 weeks.
","Children under 18 years: Should be given only on medical advice.
Children and adolescents: Agomelatine is not recommended in the treatment of depression in patients .
Use in the elderly: Efficacy has not been clearly demonstrated in the elderly (65 years). Only limited clinical data is available on the use of Agomelatine in elderly patients 65 years with major depressive episodes. Therefore, caution should be exercised when prescribing Agomelatine to these patients.
","There is limited experience with agomelatine overdose. During the clinical development, there were a few reports of agomelatine overdose, taken alone (up to 450 mg) or in combination (up to 525 mg) with other psychotropic medicinal products. Signs and symptoms of overdose were limited and included drowsiness and epigastralgia. No specific antidotes for agomelatine are known. Management of overdose should consist of treatment of clinical symptoms and routine monitoring. Medical follow-up in a specialised environment is recommended.
",,,"Store in a cool and dry place away from light. Keep out of the reach of children.
",13
+1287,Aflibercept,aflibercept-1287,https://medex.com.bd/attachments/ltMgXmp0moDHkyXQs55BpGOupdSwzW/aflibercept-aflibercept-zaltrap-prescribing-information,Cytotoxic Chemotherapy,Colorectal cancer,"Aflibercept, in combination with 5-fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen.
","Cytotoxic Chemotherapy
","Ablibercept is a recombinant fusion protein that acts as a decoy receptor for the ligands, vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PIGF). It prevents these ligands to binding to endothelial receptors, VEGFR-1 and VEGFR-2, to suppress neovascularization and decrease vascular permeability. This ultimately will slow vision loss or the progression of metastatic colorectal cancer.
","4 mg/kg as an intravenous infusion over 1 hour every 2 weeks. Do not administer as an intravenous (IV) push or bolus.
","Preparation for Administration: Inspect vials visually prior to use. Aflibercept is a clear, colorless to pale yellow solution. Do not use vial if the solution is discolored or cloudy or if the solution contains particles. Do not re-enter the vial after the initial puncture. Discard any unused portion left in the vial. Withdraw the prescribed dose of Aflibercept and dilute in 0.9% sodium chloride solution, 5% dextrose solution for injection, to achieve a final concentration of 0.6–8 mg/mL.
Use polyvinyl chloride (PVC) infusion bags containing bis (2-ethylhexyl) phthalate (DEHP) or polyolefin infusion bags. Store diluted Aflibercept at 2°–8°C for up to 24 hours, or at controlled room temperature 20°–25°C for up to 8 hours. Discard any unused portion left in the infusion bag.
Administration: Administer the diluted Aflibercept solution as an intravenous infusion over 1 hour through a 0.2 micron polyethersulfone filter. Do not use filters made of polyvinylidene fluoride (PVDF) or nylon. Do not administer as an intravenous (IV) push or bolus. Do not combine Aflibercept with other drugs in the same infusion bag or intravenous line.
","No dedicated drug-drug interaction studies have been conducted for Aflibercept. No clinically important pharmacokinetic drug-drug interactions were found between ziv-aflibercept and irinotecan/SN-38 or 5-FU, based on cross-study comparisons and population pharmacokinetic analyses.
",,"Most common adverse reactions (all grades, ≥20% incidence and at least 2% greater incidence for the Aflibercept/FOLFIRI regimen) were leukopenia, diarrhea, neutropenia, proteinuria, AST increased, stomatitis, fatigue, thrombocytopenia, ALT increased, hypertension, weight decreased, decreased appetite, epistaxis, abdominal pain, dysphonia, serum creatinine increased, and headache
","Pregnancy category C. There are no adequate and well-controlled studies with Aflibercept in pregnant women. Aflibercept was embryotoxic and teratogenic in rabbits at exposure levels lower than human exposures at the recommended dose, with increased incidences of external, visceral, and skeletal fetal malformations. Aflibercept should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether Aflibercept is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Aflibercept, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
","Adverse reactions, sometimes severe and life-threatening or fatal, have been seen in clinical trials with Aflibercept, including:
+
+- Fistula Formation: Discontinue Aflibercept if fistula occurs.
+- Hypertension: Monitor blood pressure and treat hypertension. Temporarily suspend Aflibercept if hypertension is not controlled. Discontinue Aflibercept if hypertensive crisis develops.
+- Arterial Thromboembolic Events (ATE) (e.g., transient ischemic attacks, cerebrovascular accident, angina pectoris): Discontinue Aflibercept if ATE develops.
+- Proteinuria: Monitor urine protein. Suspend Aflibercept when proteinuria ≥ 2 grams per 24 hours. Discontinue Aflibercept if nephrotic syndrome or thrombotic microangiopathy (TMA) develops.
+- Neutropenia and Neutropenic Complications: Delay administration of Aflibercept/FOLFIRI until neutrophil count is ≥ 1.5 × 109/L.
+- Diarrhea and Dehydration: Incidence of severe diarrhea and dehydration is increased. Monitor elderly patients more closely.
+- Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue Aflibercept.
+
","Pediatric Use: The safety and effectiveness in pediatric patients have not been established. In a dose-escalation, safety, and tolerability study, 21 patients ages 2 to 21 years (median age 12.9) with solid tumors received Aflibercept at doses ranging from 2 to 3 mg/kg, IV, every two weeks. The pharmacokinetics of free ziv-aflibercept were evaluated in 8 of these patients (ages 5 to 17 years). The maximum tolerated dose in the study was 2.5 mg/kg, below the dose known to be safe and effective in adults with mCRC.
Geriatric Use: Of the 611 patients with mCRC, patients treated with Aflibercept/FOLFIRI, 205 (34%) were 65 years or older, and 33 (5%) were 75 years or older. Elderly patients (≥65 years of age) experienced higher incidences (≥5%) of diarrhea, dizziness, asthenia, weight decrease, and dehydration when compared to younger patients. Monitor elderly patients more closely for diarrhea and dehydration
The effect of Aflibercept on overall survival was similar in patients <65 years old and ≥65 years old who received Aflibercept/FOLFIRI. No dose adjustment of Aflibercept is recommended for patients greater than or equal to 65 years of age.
Hepatic Impairment: No dedicated clinical studies have been conducted to evaluate the effect of hepatic impairment on the pharmacokinetics of ziv-aflibercept. Based on a population PK analysis with data from 1507 patients, ziv-aflibercept exposure in patients with mild and moderate hepatic impairment were similar to those in patients with normal hepatic function. There are no data available for patients with severe hepatic impairment.
Renal Impairment: No dedicated clinical studies have been conducted to evaluate the effect of renal impairment on the pharmacokinetics of ziv-aflibercept. Based on a population PK analysis with data from 1507 patients, ziv-aflibercept exposure in patients with mild, moderate, and severe renal impairment were similar to those in patients with normal renal function [see Clinical Pharmacology.
Females and Males of Reproductive Potential: Male and female reproductive function and fertility may be compromised during treatment with Aflibercept, as suggested by findings in monkeys [see Nonclinical Toxicology. These animal findings were reversible within 18 weeks after cessation of treatment. Females and males of reproductive potential should use highly effective contraception during and up to a minimum of 3 months after the last dose of treatment.
","There have been no cases of overdose reported with Aflibercept. There is no information on the safety of Aflibercept given at doses exceeding 7 mg per kg every 2 weeks or 9 mg per kg every 3 weeks.
",,,"Store Aflibercept vials in a refrigerator at 2 to 8° C . Keep the vials in the original outer carton to protect from light.
",12
+1849,Afatinib Dimaleate,afatinib-dimaleate-1849,https://medex.com.bd/attachments/j6djgcewuZ9ucKUjnz6w9pkQ3BLvNS/afatinib-dimaleate-prescribing-information,Tyrosine Kinase Inhibitor,Non-small cell lung cancer,"EGFR Mutation-Positive, Metastatic Non-Small Cell Lung Cancer: Afatinib is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved ... Read more
EGFR Mutation-Positive, Metastatic Non-Small Cell Lung Cancer: Afatinib is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.
Limitation of Use: The safety and efficacy of Afatinib have not been established in patients whose tumors have resistant EGFR mutations.
Previously Treated, Metastatic Squamous NSCLC: Afatinib is indicated for the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy.
","Tyrosine Kinase Inhibitor
","Afatinib covalently binds to the kinase domains of EGFR (ErbB1), HER2 (ErbB2), and HER4 (ErbB4) and irreversibly inhibits tyrosine kinase autophosphorylation, resulting in downregulation of ErbB signaling. Certain mutations in EGFR, including non-resistant mutations in its kinase domain, can result in increased autophosphorylation of the receptor, leading to receptor activation, sometimes in the absence of ligand binding, and can support cell proliferation in NSCLC. Non-resistant mutations are defined as those occurring in exons constituting the kinase domain of EGFR that lead to increased receptor activation and where efficacy is predicted by 1) clinically meaningful tumor shrinkage with the recommended dose of afatinib and/or 2) inhibition of cellular proliferation or EGFR tyrosine kinase phosphorylation at concentrations of afatinib sustainable at the recommended dosage according to validated methods. The most commonly found of these mutations are exon 21 L858R substitutions and exon 19 deletions.
Afatinib demonstrated inhibition of autophosphorylation and/or in vitro proliferation of cell lines expressing wild type EGFR and in those expressing selected EGFR exon 19 deletion mutations, exon 21 L858R mutations, or other less common non-resistant mutations, at afatinib concentrations achieved in patients. In addition, afatinib inhibited in vitro proliferation of cell lines overexpressing HER2.
Treatment with afatinib resulted in inhibition of tumor growth in nude mice implanted with tumors either overexpressing wild type EGFR or HER2 or in an EGFR L858R/T790M double mutant model.
","Patient Selection for Non-Resistant EGFR Mutation-Positive Metastatic NSCLC: Select patients for first line treatment of metastatic NSCLC with Afatinib based on the presence of non-resistant EGFR mutations in tumor specimens.
Recommended Dose: The recommended dose of Afatinib is 40 mg orally, once daily until disease progression or no longer tolerated by the patient.
Renal impairment: 30 mg orally, once daily in patients with severe renal impairment.
Instruct patients to take Afatinib at least 1 hour before or 2 hours after a meal.
",,"Co-administration of P-gp inhibitors can increase afatinib exposure. Reduce Afatinib by 10 mg per day if not tolerated. Co-administration of chronic P-gp inducers orally can decrease afatinib exposure. Increase Afatinib by 10 mg per day as tolerated.
",,"Most common adverse reactions (≥20%) were diarrhea, rash/acneiform dermatitis, stomatitis, paronychia, dry skin, decreased appetite, nausea, vomiting, pruritus.
","Based on findings from animal studies and its mechanism of action, Afatinib can cause fetal harm when administered to a pregnant woman. There are no available data on the use of Afatinib in pregnant women. Administration of afatinib to pregnant rabbits during organogenesis at exposures approximately 0.2 times the exposure in humans at the recommended dose of 40 mg daily resulted in embryotoxicity and, in rabbits showing maternal toxicity, increased abortions at late gestational stages [see Data]. Advise a pregnant woman of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
There are no data on the presence of afatinib in human milk or its effects on the breastfed infant or on milk production. Afatinib was present in the milk of lactating rats. Because of the potential for serious adverse reactions in nursing infants from Afatinib, advise a lactating woman not to breastfeed during treatment with Afatinib and for 2 weeks after the final dose.
","Diarrhea: Diarrhea may result in dehydration and renal failure. Withhold afatinib for severe and prolonged diarrhea not responsive to anti-diarrheal agents.
Bullous and exfoliative skin disorders: Severe bullous, blistering, and exfoliating lesions occurred in 0.2% of patients. Discontinue for life-threatening cutaneous reactions. Withhold afatinib for severe and prolonged cutaneous reactions.
Interstitial lung disease (ILD): Occurs in 1.6% of patients. Withhold afatinib for acute onset or worsening of pulmonary symptoms. Discontinue afatinib if ILD is diagnosed.
Hepatic toxicity: Fatal hepatic impairment occurs in 0.2% of patients. Monitor with periodic liver testing. Withhold or discontinue afatinib for severe or worsening liver tests.
Keratitis: Occurs in 0.7% of patients. Withhold afatinib for keratitis evaluation. Withhold or discontinue afatinib for confirmed ulcerative keratitis.
Embryo-fetal toxicity: Can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to the fetus and to use effective contraception.
",,,,,"Store at 25°C; excursions permitted to 15°-30°C. Dispense medication in the original container to protect from exposure to high humidity and light.
",9
+1057,Adsorbed Tetanus Vaccine,adsorbed-tetanus-vaccine-1057,https://medex.com.bd/attachments/8jOwn6O02d3B16GeUshPn10SxAnstY/adsorbed-tetanus-vaccine-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Tetanus,"
+- For the active immunization of infants, children 7 years of age or older and adults against tetanus, wherever combined antigen preparations are not indicated.
+- For the prevention of neonatal tetanus in infants by immunizing women of childbearing age or infants bom of unvaccinated pregnant women.
... Read more
+- For the active immunization of infants, children 7 years of age or older and adults against tetanus, wherever combined antigen preparations are not indicated.
+- For the prevention of neonatal tetanus in infants by immunizing women of childbearing age or infants bom of unvaccinated pregnant women.
+- Those who are liable to be exposed to tetanus infection and persons engaged in outdoor activities e.g. gardeners, agricultural, veterinary, athletes, industrial, sewage, road and outdoor workers, etc.
+- This vaccine is not to be used for the treatment of tetanus infection. If passive immunization is required, Tetanus Immunoglobulin (TIG) should be used.
+
","Vaccines, Anti-sera & Immunoglobulin
","Tetanus toxoid adsorbed is a sterile suspension on aluminium phosphate suspended in an isotonic sodium chloride solution. The vaccine, after shaking, is a turbid liquid, whitish-gray in color. Adsorbed tetanus toxoid is prepared from tetanus toxin, produced by the growth of the bacterium Clostridium tetani in a peptone-based media. The toxin is converted to tetanus formol toxoid by treatment with formaldehyde solution. Formol tetanus toxoid is then purified, sterile, filtered and adsorbed to the aluminium phosphate.Thiomersal is added as preservative.
","Primary immunization for persons 7 years of age and older-
+A series of three doses of 0.5 ml each, of adsorbed tetanus vaccine should be given intramuscularly
+
+- First dose: At appropriate date
+- Second dose: 4 to 8 weeks after the first dose
+- Third dose: 6 to 12 months after the second dose
+
+Children older than 7 years who did not complete primary immunization series (e.g., previously received only two doses of DTaP or DTP) need to receive only one dose of tetanus toxoid adsorbed vaccine to complete the primary series of tetanus. Interruption of the recommended schedule with a delay between doses does not interfere with the final immunity achieved with adsorbed tetanus vaccine. There is no need to start the series over again, regardless of the time elapsed between doses.
Routine booster injections: To maintain adequate protection, a booster dose of 0.5 ml of adsorbed tetanus vaccine every 10 years thereafter is recommended.
+
Vaccination of injured persons-
+Clean and minor wound:
+
+- If primary immunization confirmed and receiving booster dose within previous 5 years, no need of additional vaccine.
+- If primary immunization confirmed and receiving booster dose more than previous 5 years, 1 dose of 0.5 ml required.
+
+All other dirty wounds (contaminated with feces, soil, and saliva):
+
+- If primary immunization confirmed and receiving booster dose within previous 5 years, 1 dose of 0.5 ml required.
+- If primary immunization confirmed and receiving booster dose more than previous 5 years, 1 dose of 0.5 ml along with tetanus immunoglobulin required.
+
+If a person has no previous vaccination or uncertain, the primary series of 3 doses of 0.5ml adsorbed tetanus vaccine should be given along with tetanus immunoglobulin with 1st dose.
+
Protection of neonatal tetanus-
+For prevention of neonatal tetanus, adsorbed tetanus vaccine is recommended for immunization of women of childbearing age.
Women (15-49 Years): For pregnant woman who have not had previous immunization, 2 doses of tetanus toxoid at four weeks interval preferably during the last two trimester or at least 2 weeks before delivery should be given during pregnancy so that protective antibody would be transferred to the infant in order to prevent neonatal tetanus, e.g. 1 dose of 0.5 ml at 6th month of pregnancy and 1 dose of 0.5 ml at 7th month of pregnancy. Pregnant woman who have completed the course of tetanus, next 10 years no need of additional dose during pregnancy. Thereafter a single booster dose would be sufficient to extend immunity.
","Method of administration: Adsorbed Tetanus Vaccine is for intramuscular injection only. Do not inject intravenously. For adults and older children Adsorbed Tetanus Vaccine should be given intramuscularly in the deltoid muscle. For infants Adsorbed Tetanus Vaccine should be given intramuscularly in the anterolateral aspect of the upper thigh. It should not be injected into the gluteal areas as the immune response may be lower. The attending physician should determine final selection of the injection site and needle size, depending upon the patient's age and the size of the target muscle. The vaccine should be shaken well before use to obtain a homogenous turbid white suspension. Please do not shake vigorously.
Preparation for administration:
+
+- The vaccine should be shaken well before use to obtain a homogenous turbid white suspension. Please do not shake vigorously.
+- The vaccine should be inspected visually for particulate matter and discoloration prior to administration. If either of these conditions exist, the vaccine should not be administered.
+- The vaccine should be used as supplied; no dilution is necessary.
+- The full recommended dose of the vaccine should be used. Any vaccine remaining in a single-dose ampoule/vial should be discarded.
+
+
Co-administration: Adsorbed tetanus vaccine can be given at the same time with other vaccine as diphtheria, tetanus, pertussis (DTP), polio (OPV), measles, mumps and rubella (MMR), Haemophilus Influenzae type b (Hib) and Meningococcal vaccines at separate sites with separate syringes. It should not be mixed with other vaccines or medicinal products in the same syringe.
","Decreased immunologic response with concurrent immunosuppressants. Neutralisation of tetanus immune globulin and tetanus toxoid adsorbed if not given at different sites using different syringes.
","Hypersensitivity to any component of the vaccine, including thiomersal, is a contraindication. This vaccine is contraindicated in patients with previous hypersensitivity to any tetanus-containing vaccine. Tetanus toxoid vaccination should be defferred during the course of any febrile illness or acute infection. A minor febrile illness such as a mild upper respiratory infection should not preclude immunization.
","Adsorbed tetanus vaccine is generally well tolerated. Most recipients of tetanus vaccine experience some reactions upon vaccination. These are generally moderate and short in duration. They mainly consist of local reactions at the injection site (erythema, induration and tenderness). Systemic reactions (malaise and elevated temperature) are reported less commonly.
","For protection of neonatal tetanus, tetanus toxoid is recommended for immunization of women of childbearing age and especially pregnant women. Tetanus toxoid may be safely administered during pregnancy and should be given to the mother at first contact or as early as possible. It is not known if tetanus toxoid is excreted in human milk. It may be administered to nursing mothers only if clearly needed.
","Do not administer IV. Use subcutaneous route in bleeding disorders. Withhold vaccination in moderate or severe febrile illness. Pregnancy, lactation, history of Guillian-Barre syndrome.
",,,,,"Keep out of the reach and sight of children. Store at +2°C to +8°C. Transportation should also be at +2°C to +8°C. Do not freeze. Discard vaccine if frozen. Protect from light.
",11
+28,Adrenaline,adrenaline-28,https://medex.com.bd/attachments/3gyTi0KnnG5oi8IMuasOim3RCVAzpe/adrenaline-prescribing-information,Other adrenoceptor stimulants,Transfusion reactions,"Adjunctive use in the management of cardiac arrest. It is used in cardiopulmonary resuscitation. Intracardiac puncture and intramyocardial injection of adrenaline may be effective when external cardiac compression and attempts to restore the circulation by electrical defibrillation or use of a pacemaker ... Read more
Adjunctive use in the management of cardiac arrest. It is used in cardiopulmonary resuscitation. Intracardiac puncture and intramyocardial injection of adrenaline may be effective when external cardiac compression and attempts to restore the circulation by electrical defibrillation or use of a pacemaker fail. Adrenaline is a drug that leads to increased blood pressure, increased heart rate, increased air entry, increased blood glucose, stimulates cardiac activity and reduces allergic reactions by reducing inflammatory response caused by histamine. Due to these properties, it is used for the treatment of allergic and anaphylactic reactions. Adrenaline is the favored treatment for anaphylactic shock and should be administered immediately if a person begins exhibiting severe allergic reactions. Adrenaline is also used in life threatening asthma when failing ventilation and continued deterioration despite nebulizer therapy.
","Anaphylaxis, Mydriatic and Cycloplegic agents, Other adrenoceptor stimulants, Respiratory stimulants: analeptics
","The actions of epinephrine resemble the effects of stimulation of adrenergic nerves. It acts on both alpha and beta receptor sites of sympathetic effector cells. Its most prominent actions are on the beta receptors of the heart, vascular and other smooth muscle. When given by rapid intravenous injection, it produces a rapid rise in blood pressure, mainly systolic, by (1) direct stimulation of cardiac muscle which increases the strength of ventricular contraction, (2) increasing the heart rate and (3) constriction of the arterioles in the skin, mucosa and splanchnic areas of the circulation.
When given by slow intravenous injection, epinephrine usually produces only a moderate rise in systolic and a fall in diastolic pressure. Although some increase in pulse pressure occurs, there is usually no great elevation in mean blood pressure. Accordingly, the compensatory reflex mechanisms that come into play with a pronounced increase in blood pressure do not antagonize the direct cardiac actions of epinephrine as much as with catecholamines that have a predominant action on alpha receptors.
","Cardiac arrest:
+
+- Intravenous injection: 1 mg injection repeated every 2-3 minutes as necessary.
+- Endotracheal: 2-3 mg via an endotracheal tube, repeated as necessary.
+- Intracardiac: 0.1 to 1 mg, direct into the atrium of the heart.
+- Intraspinal: Usual dose is 0.2 to 0.4 mg added to anesthetic spinal fluid mixture (to prolong anesthetic action by limiting absorption).
+
+Anaphylaxis, asthma or severe bronchospasm:
+
+- Adult dose is 0.25 0.5 mg. It may be repeated at 5 minutes intervals until perfusion and respiratory status normalizes.
+- In case of dose dilution: 1 mg of Adrenaline to be diluted in 9 ml Normal Saline.
+
+
Children: Initially 10 mcg/kg body weight, not to exceed 250 mcg. May be repeated every 3-5 minutes if necessary. Subsequent doses should be 100 mcg/kg.
",,"Use of Adrenaline with excessive doses of digitalis, mercurial diuretics or other drugs that sensitize the heart to arrhythmias is not recommended. The adverse effects of Adrenaline may be potentiated by tricyclic antidepressants; certain antihistamines; e.g, Diphenhydramine, Tripelennamine, Chlorpheniramine and L-thyroxine Sodium.
","Hypertension, arteriosclerosis, coronary disease and hyperthyroidism. Not to be given to patients taking monoamine oxidase inhibitors.
","Common side effects are anxiety, restlessness, dizziness, headache, palpitations, rapid pulse, tremors, weakness and coldness of the extremities may be reported even with small doses and especially when given in conjunction with local anaesthetics.
","Pregnancy Category C. It crosses the placenta and is excreted in breast milk. Adrenaline should only be used in pregnancy if the potential benefits outweigh the risks to the fetus. It is excreted in breast milk and therefore Adrenaline is not recommended for use during lactation because of the risk of adverse effects of infants.
","The solution should not be used if it is pinkish or darker than slightly yellow or if it contains a precipitate. Adrenaline is readily destroyed by alkalies and oxidizing agents. In the latter category are Oxygen, Chlorine, Iodine, Permanganates, Chromates, Nitrites and salts of easily reducible metals, especially Iron. Adrenaline should not be mixed with Sodium bicarbonate; the solution is oxidised to adrenochrome and then forms polymers. Administer slowly with caution to elderly patients and to patients with ischemic heart disease, hypertension, diabetes mellitus, hyperthyroidism or psychoneurosis. Use with extreme caution in patients with long-standing bronchial asthma and emphysema who have developed degenerative heart disease. Anginal pain may be induced when coronary insufficiency is present.
",,"Cardiac arrhythmia leading to ventricular fibrillation, severe hypertension leading to pulmonary edema and cerebral hemorrhage. Combined alpha and beta-adrenergic blocking agents such as Labetalol may counteract the effects of adrenaline, or a beta-blocking agent may be used to treat any supraventricular arrhythmias and Phentolamine to control the alpha-mediated effects on the peripheral circulation. Rapidly acting vasodilators such as nitrates and Sodium Nitroprusside may also be helpful. Immediate resuscitation support must be available.
",,,"Store below 25°C. Protect from light. Keep out of the reach of children.
",11
+1768,Dasamularista,dasamularista-1768,,Herbal and Nutraceuticals,Anorexia nervosa,"
+- An ideal tonic for post natal care
+- Puerperal fever & Spermatorrhoea
+- Physical exhaustion & nervous debility
+- Anorexia
+
","Herbal and Nutraceuticals
","
+- Aegle marmelos: It is cooling, astringent, restorative, febrifuge and stomachic. It is used in puerperal fever, postnatal complications, breast pain, constipation, convulsion, cramps, colic & dysentery.
+- Oroxylum indicum: It is astringent, stomachic and tonic. It is used in urinogenital disorders, abdominal pain, thirst, vomiting, anorexia and oedema.
+- Gmelina arborea: It is astringent, stomachic, nervine tonic and galactagogue. It is used in burning sensation, fever, thirst, emaciation, nervous disorders and giddiness.
+- Stereospermum suaveolens: It is astringent, cooling and tonic. It is used in anorexia, difficult breathing, fever, inflammations, eructations, anasarca and vomiting.
+- Premna integrifolia: It is acrid, astringent and tonic. It is used in obstinate fevers, constipation and aqueous extracts of the plant has a constructive action on uterus.
+- Desmodium gangeticum: It is antipyretic, astringent in diarrhoea and tonic. It is used in post natal care to avoid secondary complications, hazy vision, burning sensation and fever.
+- Uraria hamosa: It is used in chills, fevers especially in puerperal fever.
+- Solanum indicum: It is used in difficult parturition, catarrhal affections, dropsy, colic, dysuria, fever and ischuria.
+- Solanum xanthocarpum: It is used in fever, difficult urination, enlargement of liver and spleen, bladder stones and pains. It promotes conception.
+- Tribulus terrestris: It is antibilious, antispasmodic and diuretic. It is used in dysuria, incontinence of urine, spermatorrhoea, irritation of urinary organs and puerperal diseases.
+
","Adult: 2-4 teaspoonful 2-3 times daily after meal.
",,,"No reported.
","No side effect or adverse effect if used at recommended dose.
","Not recommended during pregnancy but recommended during lactation.
",,,,,,"Keep all medicines out of reach of the children. Store in a cool and dry place, protected from light.
",8
+1534,Curcuminoids [Curcuma Longa],curcuminoids-curcuma-longa-1534,,Herbal and Nutraceuticals,Rheumatoid arthritis,"Curcuminoids (Curcuma longa) tablet is indicated for-
+
+- Rheumatoid arthritis
+- Osteoarthritis
+- Traumatic swelling and pain
+- Dental plaque
+- Cancer associated pain or inflammation
+
","Herbal and Nutraceuticals
","Curcuminoids is the yellow pigment of Curcuma longa and has long traditional medicinal use in gastric ulcers and dyspepsia. Modern cellular studies on Curcuminoids with almost 4000 pre-clinical investigations, prove it as one of the best studied natural products of the whole biomedical literature. Curcuminoids is known as a master switch of addressing the natural inflammatory response function by down regulating the expression of a series of cytokines, enzymes and transcription factors. Curcuminoids significantly reduces the expression of COX-2, TNF-α, IL-1β, IL-1RN and IL-6. It inhibits the formation of prostaglandin. Curcuminoids also has anti oxidative, anti-tumoral, anti-microbial and choleretic action.
","Orally 1-2 tablets daily after meal or as directed by physician.
",,,"Contraindicated in patients with a known hypersensitivity to curcuminoids. Curcuminoids is contraindicated in obstruction of bile passages. In case of gallstones, use only after consulting with a physician.
","Curcuminoids is well tolerated in recommended dose. Occasionally gastrointestinal disturbance may occur with overdose.
","Not recommended during pregnancy. No known restrictions during lactation.
",,,,,,"Store in a cool and dry place, away from light & moisture. Keep out of reach of children.
",8
+2064,Curcuma Longa [Turmeric Extract],curcuma-longa-turmeric-extract-2064,https://medex.com.bd/attachments/8Fx4ejEtzybaCkoeKaujcXD0HDQa38/curcuma-longa-turmeric-extract-prescribing-information,Herbal and Nutraceuticals,,"Turmeric is used for dyspeptic disorders particularly feelings of fullness after meals and regular abdominal distention due to gas, osteoarthritis, rheumatoid arthritis, inflammation of the oral mucosa, Inflammatory skin conditions and infected wounds, cystitis, itching & skin disease.
","Herbal and Nutraceuticals
","Turmeric has antihepatotoxic, antihyperlipidemic, antithrombotic and anti-inflammatory effects. It is also antioxidative, antitumoral and antimicrobial (in particular, the sesquiterpene derivatives). It also inhibits prostaglandin formation. The anti-inflammatory effects of turmeric are thought to be due to inhibition of leukotriene biosynthesis and through this inhibition a change in prostaglandin formation. Alpha tumerone blocks the proliferation of human lymphocytes and decrease the activity of natural killer cells. Curcumin has antineoplastic effects through an antiproliferative mechanism.
","1-2 capsules daily. Or, as directed by the registered physician.
",,"Concurrent use of turmeric with antiplatelet, heparin, thrombolytic agents result in increased risk of bleeding.
","Turmeric should not be used by people with gallstones or bile duct obstruction. It should also not be used by patients with hyperacidity or gastrointestinal ulcers.
","Turmeric usually does not cause significant side effects; however, some people can experience stomach upset, nausea, dizziness, or diarrhea.
","Not to be used during pregnancy.
","Stomach complaints can occur following extended use or in the case of overdose.
",,,,,"Keep out of reach of the children. Keep away from direct sunlight. Store below 30°C in a dry place.
",10
+1533,Cranberry [Vaccinium macrocarpon],cranberry-vaccinium-macrocarpon-1533,,Herbal and Nutraceuticals,Urinary tract infection,"Cranberry is indicated for-
+
+- The treatment and prevention of urinary tract infection.
+- Kidney stones.
+
","Herbal and Nutraceuticals
","Cranberry (Vaccinium macrocarpon) is a native North American plant commonly used for reduction in urinary tract infections (UTIs) occurrence and kidney stone management. Cranberry reduces the need for repeated antibiotic use in the treatment of recurrent urinary tract infection. Bacterial adherence to mucosal surfaces is generally considered to be the initial event in the pathogenesis of most infectious diseases due to bacteria in human such as UTIs. Cranberry inhibits adherence of bacteria to the lining of the urinary bladder and urethra. At higher dose it also works as a urinary antiseptic and reduces incidence of stone formation. Recent publications show as much as 65% reduction in UTI with cranberry consumption leading to reduced use of antibiotics and reduction in the number of incidences of recurrent cystitis.
","1-3 capsules daily or as advised by the physician.
",,"No known interactions with antibiotics or other drugs. Cranberry enhances vitamin B12 absorption, which is useful for patients taking omeprazole, a drug used to treat ulcers.
","Potential contraindications of cranberry may be present with renal insufficiency and in persons with the potential for developing uric acid or calcium oxalate stones.
","Well tolerated in recommended dose. Occasionally diarrhea or mild gastrointestinal upset may occur at high dose.
","No known restrictions during pregnancy or lactation.
",,,,,,"Store in a cool and dry place, away from light and moisture. Keep out of reach of children.
",9
+1746,Compound Asparagus,compound-asparagus-1746,,Herbal and Nutraceuticals,General weakness,"This is indicated in sexual weakness, oligospermia, physical stress.
","Herbal and Nutraceuticals
","Shatomuli (Asparagus racemosus): It contains shatavarin, alkaloid, protein, starch and tannin. It has immunomodulator, nutritive, antibacterial and antioxidant activity. It is a powerful drug capable of improving memory power, intelligence and physical strength. It is useful in nervous disorders and general debility.
Aswagandha (Withania somnifera): It contains alkaloids (tropine, pseudotropine, hygrine, anaferine) and withanolides (withaferin A). It is stimulant and aphrodisiac. It is effective in nervous exhaustion, spermatorrhoea and senile debility. Powder of root mixed with equal parts of ghee and honey is beneficial in impotency or seminal debility. Berela (Sida cordifolia): It contains ephedrine and potassium nitrate. It is used in facial paralysis, sciatica, rheumatism and neurological disorders. It is also used as an aphrodisiac.
Bhumikusmando (Ipoema paniculata): It contains taraxcrol and sitosterol. It is restorative and aphrodisiac. It is used to increase weight reduced due to mental and physical fatigue.
","Adult: 2-4 teaspoonful 2 times daily after meal.
",,,"No reported.
","No side effect or adverse effect if used at recommended dose.
","Not recommended during pregnancy.
",,,,,,"Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.
",8
+1549,Collagen II & GAGs,collagen-ii-gags-1549,,Herbal and Nutraceuticals,Relieve pain,"Collagen II & GAGs helps to
+
+- Maintain stronger bones
+- Relieve joint pain and discomfort
+- Maintain proper movements of joints
+- Maintain proper health of cartilages
+- Regain healthier tone of skin
+- Boost up energy level for the elderly person
+- Relieve constipation, increase elasticity of blood vessels and prevent various cardiovascular diseases.
+
","Herbal and Nutraceuticals
","Collagen is a primary structural protein which forms cartilages, bones, tendons, ligaments, skin and other connective tissues of the body. Body’s collagen production is reduced due to aging which causes joints pain, degenerative bone diseases, wrinkles and brittle hair. Collagen II is the main ingredient of joint cartilage and it is around 90% of total protein. Collagen II & GAGs Tablet contains the collagen II which is collected from natural sources. It can prevent and helps to repair the degeneration and assists in treatments of bones and joints diseases, including osteoarthritis and osteoporosis. Collagen II & GAGs Tablet helps to maintain optimum health of skin and hair.
","1-2 Tablets 2-3 times daily with luke warm water. Taking Collagen II & GAGs Tablet for 1 month helps to relieve pain associated with osteoporosis of elderly people. After 3 months, the density and elasticity of bones can be improved to a satisfactory level. For arthritic patients, after using this Tablet for 2 months, joint pain is expected to improve significantly. Administrations of this Tablet for 6-12 months, the deteriorated joints are usually restored to almost normal condition in many patients so they can move easily.
",,"No drug interaction is yet reported.
",,"This tablet is an organic nutritional supplement with no adverse effects.
",,,,,,,"Keep in a cool and dry place, away from direct sunlight
",7
+302,Coenzyme Q10 [Ubidecarenone],coenzyme-q10-ubidecarenone-302,https://medex.com.bd/attachments/NjIkvUTtftycLLgoehmToYwEZIB5FI/coenzyme-q10-ubidecarenone-prescribing-information,Supplements & adjuvant therapy,Skin moisturization,"It is indicated for Co-enzyme Q10 deficiency and mitochondrial disorders. It is also used in congestive heart failure, myocardial infarction, high blood pressure (hypertension) in combination with other medications, preventing migraine headache, parkinson's disease, improving the immune system, infertility in men and muscular dystrophy.
","Herbal and Nutraceuticals, Supplements & adjuvant therapy
","Co-enzyme Q10 is a vitamin-like substance found throughout the body especially in the heart, liver, kidney and pancreas. It is required for the proper function of many organs and chemical reactions in the body. It helps to provide energy to cells. It has antioxidant activity.
","For Co-enzyme Q10 deficiency: 150 mg daily.
For mitochondrial disorders: 150-160 mg, or 2 mg/kg/day.
For heart failure in adults: 100 mg per day divided into 2 or 3 doses.
For recent myocardial infarction: 120 mg daily in 2 divided doses.
For high blood pressure: 120-200 mg per day divided into 2 doses.
For isolated systolic hypertension: 60 mg twice daily.
For preventing migraine headache: 100 mg three times daily.
For Parkinson's disease: 300 mg, 600 mg, 1200 mg and 2400 mg per day in 3-4 divided doses.
For infertility in men: 200-300 mg per day.
For muscular dystrophy: 100 mg per day.
Dividing the total daily dose by taking smaller amounts two or three times a day instead of a large amount all at once can help to reduce side effects.
",,"Antihypertensive drugs: May cause blood pressure to go too low.
Anticancer drugs: May decrease the effectiveness of some anticancer drugs.
Warfarin: May decrease the effectiveness of warfarin.
","Co-enzyme Q10 is contraindicated in patients who have hypersensitivity to the active substance or to any of the excipients. It is also contraindicated in patients scheduled for surgery in the next two weeks.
","Co-enzyme Q10 is safe for most adults. It can cause some mild side effects including stomach upset, loss of appetite, nausea, vomiting, and diarrhea. It can cause allergic skin rashes in some people.
","Co-enzyme Q10 should not be used in pregnancy and breast-feeding.
","Co-enzyme Q10 may lower blood sugar levels, so caution should be taken in patients with diabetes or hypoglycemia. Co-enzyme Q10 may decrease blood pressure so caution is advised in patients with low blood pressure or taking blood pressure medications.
",,,,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",10
+1612,Chirata [Swertia Chirata],chirata-swertia-chirata-1612,,Herbal and Nutraceuticals,Stabilize blood sugar,"Chirata (Swertia Chirata) is indicated in-
+
+- Dyspepsia, Appetite Suppressant, gastric juice secretion & gastrointestinal tract disturbance.
+- Control acidity, gas, indigestion, naturally.
+- Controls blood sugar.
+- Reduce intermittent & remittent fever.
+- Reduce obesity & cholesterol naturally.
... Read more
Chirata (Swertia Chirata) is indicated in-
+
+- Dyspepsia, Appetite Suppressant, gastric juice secretion & gastrointestinal tract disturbance.
+- Control acidity, gas, indigestion, naturally.
+- Controls blood sugar.
+- Reduce intermittent & remittent fever.
+- Reduce obesity & cholesterol naturally.
+- Anti-allergic agent & protects liver & kidney naturally.
+- lt is useful in skin diseases like acne, pimples and other infections of skin.
+- Develops immunity.
+- Long term uses of Chirata capsule destroy intestinal worms.
+
","Herbal and Nutraceuticals
",,"1-2 Capsules 2-3 times daily or as directed by the registered physician.
",,"There has no information for Chirata Interactions.
","It is contraindicated in pregnancy & lactation.
","No significant side effects have been observed in proper dosage.
",,"This drug should be used with caution in patient with ulceration in stomach and colon due to the secretion of gastric juice.
",,,,,"Keep out of reach of children. Keep away from direct sunlight. Keep store in a cool and dry place.
",8
+1702,Chebulic Myrobalan + Barberry,chebulic-myrobalan-barberry-1702,,Herbal and Nutraceuticals,Haemorrhoids (Piles),"This is indicated in-
+
+- Haemorrhoid (piles)
+- Constipation
+- Flatulence
+
","Herbal and Nutraceuticals
","This is a unique combination of Chebulic Myrobalan (Terminalia chebula), Barberry (Berberis aristata) and other natural ingredients, which helps to relieve haemorrhoid and constipation. It reduces swelling and inflammation of rectal mucosa, acts as mild laxative, prevents undue pressure on rectal muscle. Hanrhoid is very effective in stomachache and flatulence.
","1 tablet twice daily or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1611,Carica Papaya Leaf Extract,carica-papaya-leaf-extract-1611,,Herbal and Nutraceuticals,Stabilize blood sugar,"কারিকা পাপায়া লিফ এক্সট্রাক্ট নিম্ন বর্ণিত রােগসমূহে নির্দেশিত-
+
+- থ্রম্বােসাইটোপেনিয়া ( প্লাটিলেট সংখ্যা কমে যাওয়া ) যা ডেঙ্গুজ্বর দ্বারা উদ্ভুত।
+- থ্রম্বােসাইটোপেনিয়া ( প্লাটিলেট সংখ্যা কমে যাওয়া ) যা কেমােথেরাপি হতে সংঘটিত। এছাড়াও
+- খাবারের রুচি বাড়ায়
+- হজমে সহায়ক
+- কোষ্ঠকাঠিন্য দূর করে
+- পাকস্থলি ও কোলনের প্রদাহ কমায়
+- যকৃত পরিষ্কার রাখে
+- রােগপ্রতিরােধ ক্ষমতা বৃদ্ধি করে
+- ব্রণ দূর করে
+- সুস্থ্য ও সুন্দর ত্বক নিশ্চিত করে
+- মাসিকের ব্যথা দূর করে।
+
","Herbal and Nutraceuticals
","কারিক��� পাপায়া উদ্ভিদ গােত্রের কারিকাসিয়া গণ এর অন্তর্গত বাণিজ্যিকভাবে বিশ্বব্যাপী গুরুত্বপূর্ণ একটি ফল জাতীয় ফসল। প্রচুর গবেষণা হয়েছে এই উদ্ভিদটির বিভিন্ন অংশের কার্যকারিতা নিয়ে যেমন- পাতা, ফল, ফলের খােসা, বীজ, কান্ড, মূল ও তরুক্ষীরের। বিবেচনা করা হয় যে পেঁপে পাতা নন- টক্সিক কারণ এর লিথাল ডােজ হচ্ছে >১৫ গ্রাম/বডি ওয়েট। ইঁদুরের উপর প্রিক্লিনিক্যাল স্টাডিতে দেখা গিয়েছে পেঁপে পাতার গুড়া রক্তের প্লাটিলেট বাড়ানােয় উৎসাহব্যাঞ্জক কার্যকারিতা দেখায়। সাম্প্রতিক কালের ইন-ভিট্রো (ল্যাবরেটরি) গবেষণায় দেখা গিয়েছে কারিকা পাপায়া লিফ এক্সট্র্যাক্ট উল্লেখযােগ্যভাবে হেমােলাইসিস বন্ধ করে এর মেমব্রেইন স্ট্যাবিলাইজিং সামর্থ্যের মাধ্যমে।
","কারিকা পাপায়া লিফ এক্সট্র্যাক্ট ২৫০ মিগ্রা ক্যাপসুলের নির্দেশিত মাত্রা হচ্ছে প্রতিদিন ১-২ টি ক্যাপসুল দিনে ২-৩ বার ৫-১২ দিন পর্যন্ত।
",,"কারিকা পাপায়া লিফ এক্সট্র্যাক্ট যদি অ্যামিওডারােন এর সঙ্গে একত্রে ব্যবহার করা হয় তাহলে অ্যামিওডারােন এর বায়ােএভেইলেবিলিটি বেড়ে যায় তাই ঔষধটির মাত্রা সমন্বয় করতে হবে। ইন-ভিট্রো (ল্যাবরেটরি) গবেষণায় দেখা গিয়েছে একত্রে কারিকা পাপায়া লিফ এক্সট্র্যাক্ট ও বিভিন্ন এন্টিবায়ােটিক সমূহ যেমনঃ পেনিসিলিন জি, এম্পিসিলিন, এমক্সিক্লাভ, সেফালােথিন, পলিমক্সিন বি, রিফাম্পিসিন, অ্যামিকাসিন, নালিডিক্সিক এসিড, জেন্টামাইসিন, ক্লোরামফেনিকল, ওফ্লক্সাসিন সেবন করলে উল্লিখিত এন্টিবায়ােটিক সমূহের কার্যকারিতা বেড়ে যায়। কারিকা পাপায়া লিফ এক্সট্র্যাক্ট ও এন্টিমাইক্রোবিয়াল এজেন্ট একসঙ্গে সেবন করলে তা জীবাণুর বিরুদ্ধে সিনার্জিস্টিক একশন দেখায়।
","অতিসংবেদনশীলতা, গর্ভধারণ। পুরুষদের ক্ষেত্রে যাদের প্রােস্টেট জটিলতা রয়েছে যেমনঃ BPH অথবা প্রােস্টেট ক্যান্সার , তাদের জন্য কারিকা পাপায়া লিফ এক্সট্র্যাক্ট প্রতিনির্দেশিত, যেহেতু এতে করে আয়রণ এর শােষণ বাড়ে। অতিরিক্ত আয়রণ অক্সিডেটিভ স্ট্রেস বাড়াতে পারে বিশেষ করে বয়স্ক পুরুষদের ক্ষেত্রে। আয়রণের ওভারলােড প্রােস্টেট ক্যান্সার হওয়ার ঝুঁকিও বাড়াতে পারে।
","বমি অথবা বমি বমিভাব, তলপেটে ব্যাথা, বুকজ্বলা, বদহজম।
","গর্ভাবস্থায় ও স্তন্যদা���কালে কারিকা পাপায়া লিফ এক্সট্র্যাক্টের ব্যবহার অনুমােদিত নয় ।
","অ্যাসপিরিন এবং ওয়ারফারিন জাতীয় রক্ত তরল করার ঔষধ ব্যবহারকারীদের ক্ষেত্রে সতর্কতা অবলম্বন করতে হবে। একটি প্রাণীগবেষণায় দেখা গেছে যে কারিকা পাপায়া লিফ এক্সট্র্যাক্ট যদি ওরাল হাইপােগ্লাইসেমিক কোনাে ঔষধের সঙ্গে ব্যবহার করা হয় তাহলে রক্তে গুকোজ এর মাত্রা অনেক কমে যেতে পারে। তাই রােগীর রক্তের গ্লুকোজ এর মাত্রা নিবিড়ভাবে পর্যবেক্ষণ করা খুবই গুরুত্বপূর্ণ যেন হাইপােগ্লাইসেমিয়া এড়ানাে যায়।
",,,,,"আলাে এবং আর্দ্রতা থেকে দূরে ৩০° সে. তাপমাত্রার নীচে সংরক্ষণ করুন।
",10
+189,Camphor + Thymol + Menthol + Eucalyptus oil,camphor-thymol-menthol-eucalyptus-oil-189,,Herbal and Nutraceuticals,Stiffness,"This is indicated in-
+
+- Headache, Toothache and Burns
+- Earache
+- Cough, Cold and Catarrh
+- Insect Bites, Burns and Scalds
+- Itching and Scabies
+- Nose Bleeding
+- Pneumonia and Lumbago
+- Stomach Troubles
+- Cholera
+- Plague and other Epidemics
+
","Herbal and Nutraceuticals
","This provides rapid relief from congestion and pain. Its widespread use rests on its safe and reliable action as an antiseptic, antiphlogistic and carminative.
","irection Headache, Toothache and Burns: Apply this preparation with cotton wool swab on the affected part.
Earache: Instill 2 drops of this preparation mixed with 2 drops of sesame (til) oil into the affected ear, 2-3 times daily.
Cough, Cold and Catarrh: Instill 2 drops of this preparation mixed with 2 drops of sesame (til) oil into the nostrils, twice a day. Massage the oil gently on the neck and chest.
Insect Bites, Burns and Scalds: Apply this preparation with cotton wool swab on the affected part.
Itching and Scabies: Apply this preparation mixed with lemon juice and sesame (til) oil on the effected part.
Nose Bleeding: Instill 2 drops of this preparation mixed with 2 drops of sesame (til) oil into nostrils twice a day.
Pneumonia and Lumbago: Melt a little beeswax in sesame (til) oil and when cold, mix 4 drops of this preparation to it. Massage the oil gently on the affected part.
Stomach Troubles: Indigestion, flatulence, loud eructation, loose motion, vomiting, nausea and dysentery take 3-4 drops of this preparation with cold water, 3-4 times daily.
Cholera: 2-3 drops of this preparation mixed with cold water for 2-3 times a day.
Plague and other Epidemics: 3-4 drops of this preparation mixed with cold water should be taken by whole family 2-3 times daily.
",,"There are no known drug interactions and none well documented.
","There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",9
+1756,Calendula Officinalis [Marigold],calendula-officinalis-marigold-1756,,Herbal and Nutraceuticals,Wounds,"It is a harbal ointment preparation for skin diseases for topical application. This is indicated in Wounds & burns, Dermatitis & dry skin, Anal eczema & proctitis, Leg ulcer, Boils, bruises & rashes.
","Herbal and Nutraceuticals
",,"Apply topically to the affected area 2 to 3 times daily or as directed by the physician.
",,,"There is no absolute contraindication.
","Not yet known.
","No restriction is known yet.
",,,,,,,6
+1684,Buzuri,buzuri-1684,,Herbal and Nutraceuticals,Secondary amenorrhoea,"Buzuri is indicated in-
+
+- Pyrexia
+- Annuria
+- Oliguria
+- Amenorrhoea
+- Hepatitis
+- Jaundice
+- It is also very effective to clear the morbid substances from the liver and kidney.
+
","Herbal and Nutraceuticals
","Buzuri is a time tested modern unani medicine, prepared with Chicory (Cichorium endivia) root & seed, Small Caltrops (Tribulus terrestris), Fennel (Foeniculum vulgare) root & seed and others valuable natural ingredients. Buzuri acts as prebiotic, antioxidant, febrifuge, diuretic and also acts as detoxifier and cleanser of liver and kidney. Buzuri relieves inflammation and normalizes body temperature. It is effective in oliguria, urinary tract infection, jaundice, hepatitis and amenorrhoea.
","Adults: 2-4 teaspoonfuls 2-4 times daily.
Children: 1-2 teaspoonful(s) 2-4 times daily or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1747,Brahmi Rasayan,brahmi-rasayan-1747,,Herbal and Nutraceuticals,Rough & defective voice,"This is indicated in-
+
+- Memory deficiency
+- Impaired speech
+- Rough & defective voice.
+
","Herbal and Nutraceuticals
","Brahmi (Bacopa monniera): It contains alkaloids brahmine, plant saponins, bacoside A & B; monniem, betulic acid, ß-sitosterol and stigmastanol. It is a potent nerve tonic, found very effective in cases of anxiety neurosis. It is an anti-anxiety agent having adaptogenic effect. Stem & leaves is brain tonic which sharpens dull memory. It improves intellect and also capable of imparting youthful vitality & longevity.
Shatomuli (Asparagus racemosus): Fresh roots yield diosgenin. Plant yields shatavarin I to IV. It is tonic & sweet. Satavari is a powerful drug capable of improving memory power, intelligence and physical strength.
Pipul (Piper longum): It contains essential oil consisting of long-chain hydrocarbons, mono- and sesquitertense, piperlongumine, sesamin and piperine. It is tonic, digestive, appetizer and anthelmintic. Pippali is capable of improving intellect & memory power and also to regain health by dispelling disease.
Boch (Acorus calamus): It contains essential oil from rhizome; calamus oil has B-asarone as major constituent together with calamen, calamenol and calameon. Asarone is a mild sedative, a potent tranquillizer. Bach is an important drug capable of improving memory power and intellect.
Ashwagandha (Withania somnifera): It contains withasomnine & steroidal lactones, withaferin A & withanolides and also contains glycosides & withaniol. It is tonic, adaptogenic, sedative and bacteriostatic. It restores loss of memory and is used in cases of nervous exhaustion. Internally it is given in marasmus in children
","Adult: 2 tea-spoonfuls 2-3 times daily after meal.
Children: 1 tea-spoonful 2-3 times daily after meal.
",,,"Not reported.
","No side effect or adverse effect if used at recommended dose.
","Not recommended during pregnancy.
",,,,,,"Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.
",8
+1538,Black Cohosh [Cimicifuga Racemosa],black-cohosh-cimicifuga-racemosa-1538,,Herbal and Nutraceuticals,Vertigo,"Black Cohosh is indicated in Premenstrual discomfort, Dysmenorrhea, Menopausal complaints such as hot flashes, heart palpitations, nervousness, irritability, sleep disturbances, tinnitus, vertigo, perspiration and depression.
","Herbal and Nutraceuticals
","Black cohosh (Cimicifuga racemosa) is popular as an alternative to hormonal therapy in the treatment of menopausal (climacteric) symptoms such as hot flashes, mood disturbances, diaphoresis, palpitations and vaginal dryness.
","1-2 capsules daily or as directed by the physician. Duration of treatment should be maximum six months at a time.
",,"Black cohosh may interact with birth control pills, hormone replacement therapy, sedatives or antihypertensive.
","No significant contraindication is observed.
","Black cohosh is safe for most people. It might cause some mild side effects such as stomach upset, cramping, headache, rash, a feeling of heaviness, and weight gain. Occasional gastrointestinal discomfort may occur.
","Not recommended during pregnancy due to an increased risk of spontaneous abortion. Not recommended during lactation.
","Black cohosh should be used cautiously in patients with liver disease, kidney disease and seizure disorders.
",,,,,"Store in a cool and dry place, away from light & moisture. Keep out of reach of children.
",10
+1213,Amino Acid + Calcium,amino-acid-calcium-1213,https://medex.com.bd/attachments/Yai4loXZaQ60I2ej1eXGMyj91SXKVK/amino-acid-calcium-prescribing-information,Drugs used in chronic kidney dialysis,Deficient protein metabolism,"Prevention and therapy of damages due to faulty or deficient protein metabolism in chronic renal insufficiency in connection with limited protein in food of 40 g/day (for adults) ie, generally in patients with a glomerular filtration rate (GFR) 25 mL/minutes.
","Drugs used in chronic kidney dialysis
","This tablet allows the intake of essential amino acids while minimising the amino-nitrogen intake. Following absorption, the keto- and hydroxy-analogues are transaminated to the corresponding essential amino acids by taking nitrogen from non-essential amino acids, therby decreasing the formation of urea by re-using the amino group. Hence, the accumulation of uraemic toxins is reduced. Keto and hydroxy acids do not induce hyperfiltration of the residual nephrons. Ketoacid containing supplements exert positive effect on renal hyper phosphataemia and secondary hyperparathyroidism. Moreover, renal osteodystrophy may be improved. The use of this tablet in combination with a very low protein diet allows to reduce nitrogen intake while preventing the deleterious consequences of inadequate dietary protein intake and malnutrition.
","Adults (70 kg body weight): If not otherwise prescribed, take 4 to 8 tablets three times a day during meals. Swallow whole and must not be chewed. Ingestion during meals facilitates proper absorption and the metabolisation into the corresponding amino acids.
Duration of Application: This tablets are given as long as the glomerular filtration rate (GFR) is between 5 and about 15 mL/minute. Simultaneously food should contain 40 g/day protein or less (adults).
",,"
+- Concomitant administration of calcium-containing drugs may cause or aggravate elevated serum calcium levels.
+- Drugs that form hardly soluble compounds with calcium (e.g. tetracyclines, quinolines such as ciprofloxacin and norfloxacin as well as drugs containing iron, fluoride or estramustine) should not be taken at the same time with this tablet to avoid disturbed absorption of the active substances. An interval of at least two hours should elapse between the ingestion of this tablet and these drugs.
+- The susceptibility to cardioactive glycosides, and hence the risk for arrhythmia will increase if this tablet produces elevated serum calcium levels.
+- Uraemic symptoms improve under therapy with this tablet. Thus, in case of aluminium hydroxide administration, the dose of this drug has to be reduced if necessary. Serum phosphate levels should be monitored for a decrease.
+
","Hypersensitivity to the active substances or to any of the excipients. Hypercalcaemia. Disturbed amino acid metabolism.
","Hypercalcemia may develop. In this case it is recommended to decrease Vitamin D intake. If hypercalcaemia persists, reduce the dosage of this tablet as well as other source of calcium. The serum calcium level should be monitored regularly. Ensure sufficient calorie intake. No experience has been gained so far with the administration in paediatric patients.
","There are no adequate data from the use of this tablet in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women. No experience has been made so far with the use during lactation. No case of overdose has been reported.
","
+- The serum calcium level should be monitored regularly.
+- Ensure sufficient calorie intake.
+- In the presence of hereditary phenylketonuria, attention should be given to the fact that this tablet contains phenylalanine.
+- Monitoring of the serum phosphate levels is needed in case of concomitant administration of aluminium hydroxide.
+
",,,,,"Do not store above 30° C. Store in the original package and keep the blisters tightly closed to protect contents from moisture.
",10
+1890,Amino Acid,amino-acid-1890,https://medex.com.bd/attachments/z9NOvGonqJOJBixAKJj4dbNcMtIHDR/amino-acid-prescribing-information,Parenteral nutritional preparations,Parenteral nutrition,"Parenteral amino acid supply in severe forms of hepatic failure (liver insufficiency) with and without encephalopathy. For supply of amino acids as part of a parenteral nutrition regimen when oral or enteral nutrition is impossible or insufficient or contraindicated.
","Parenteral nutritional preparations
",,"
+- For intravenous infusion.
+- Usual dose: 1.0 to 1.25 ml/kg/hour.
+- Max. dosage: 1.5 g amino acids/kg/day = 1300 ml/day at 70 kg body weight.
+- Constant checking of serum electrolytes, fluid balance and acid-base balance is mandatory.
+- Amino Acid 8% is used as long as required by therapy.
+
",,"Because of the increased risk of microbiological contamination and incompatibilities, amino acid solutions should not be mixed with other drugs. Should it become necessary to add other nutrients like carbohydrates, lipid emulsions, electrolytes, vitamins or trace elements to Amino Acid 8% for complete nutrition, care should be given to hygienic admixing, good blending and, in particular, to compatibility.
","Disturbance of amino acid metabolism, metabolic acidosis, fluid overload, hyponatremia, hypokalemia, renal insufficiency, decompensated cardiac insufficiency, shock, hypoxia. No specific studies have been performed to assess the safety of Amino Acid 8% in pregnancy and lactation.
","Due to the special composition of this preparation, use in indications other than those recommended may result in amino acid imbalances and severe metabolic disorders.
",,,,,,,"Amino Acid 8% should not be stored after the addition of other components. Do not store above 25°C. Do not freeze. Shelf Life: 36 months. Do not use Amino Acid after the expiry date. Do not use if the solution is cloudy or if the container is damaged. Keep out of the reach of children.
",7
+54,Amikacin,amikacin-54,https://medex.com.bd/attachments/owvLaZ8vPY7lgLesS1GDnZsC0ezpEF/amikacin-prescribing-information,Aminoglycosides,Urinary tract infection,"Amikacin is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria. Amikacin is effective in bacterial septicemia (including neonatal sepsis); in serious infections of the respiratory tract, bones and joints, central nervous system (including ... Read more
Amikacin is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria. Amikacin is effective in bacterial septicemia (including neonatal sepsis); in serious infections of the respiratory tract, bones and joints, central nervous system (including meningitis) and skin and soft tissue; intra-abdominal infections (including peritonitis); and in burns and postoperative infections (including postvascular surgery). Clinical studies have shown Amikacin also to be effective in serious complicated and recurrent urinary tract infections due to those organisms.
Amikacin was effective in infections caused by gentamicin and/or tobramycin-resistant strains of Gram-negative organisms, particularly Proteus rettgeri, Providencia stuartii, Serratia marcescens, and Pseudomonas aeruginosa.
Amikacin has also been shown to be effective in staphylococci infections and may be considered as initial therapy under certain conditions in the treatment of known or suspected staphylococcal disease such as, severe infections where the causative organism may be either a Gram-negative bacterium or a staphylococcus.
","Aminoglycosides
","Amikacin Sulfate is a semi-synthetic aminoglycoside antibiotic. Amikacin is active in vitro against pseudomonas species, Escherichia coli, Proteus species, Providencia species, Klebsiella-Enterobacter species, Acinetobacter species, and Citrobacter freundii. When strains of the above organisms are found to be resistant to other aminoglycosides, including Gentamicin, TobrAmykin and KanAmykin, many are susceptible to Amikacin. Amikacin sulfate is active in vitro against penicillinase and nonpenicillinase-producing Staphylococcus species including methicillin-resistant strains.
","Adults and children: 15 mg/kg/day in two equally-divided doses (equivalent to 500 mg bid in adults). Use of the 100 mg is recommended for children for the accurate measurement of the appropriate dose.
Neonates and premature children: An initial loading dose of 10 mg/kg followed by 15 mg/kg/day in two equally divided doses.
Elderly: Amikacin is excreted by the renal route. Renal function should be assessed whenever possible and dosage adjusted as described under impaired renal function.
Life-threatening infections and/or those caused by Pseudomonas: The adult dose may be increased to 500 mg every eight hours but should neither exceed 1.5g/day nor be administered for a period longer than 10 days. A maximum total adult dose of 15g should not be exceeded.
Urinary tract infections (other than pseudomonal infections): 7.5mg/kg/day in two equally divided doses (equivalent to 250 mg b.i.d. in adults).
Impaired renal function: In patients with impaired renal function, the daily dose should be reduced and/or the intervals between doses increased to avoid accumulation of the drug.
","Intramuscular or intravenous administration: For most infections the intramuscular route is preferred, but in life threatening infections, or in patients in whom intramuscular injection route is not feasible the intravenous route may be used.
Intraperitoneal use: Amikacin may be used as an irrigant after recovery from anesthesia in concentration of 0.25%.
","Concurrent administration of Amikacin with myorelaxants leads to potentiation of their effects and there is a possibility of cessation of the breathing. The combination with other Aminoglycoside antibiotics should be avoided because of the augmentation of their ototoxic and nephrotoxic effects. Concurrent administration of Amikacin with fast acting diuretics increases the risk of ototoxicity in patients with renal failure. Combination with Cephalosporins or Polymixins increases the risk of nephrotoxicity.
","Amikacin Injection is contraindicated in patients with a known history of hypersensitivity to Amikacin, any constituents of the injection.
","The adverse effects have been reported with the use of Amikacin are tinnitus, vertigo, partial reversible or irreversible deafness, skin rash, drug fever, headache, paraesthesia, nausea and vomiting.
","Amikacin rapidly crosses the placenta into the foetal circulation and amniotic fluid and there is a potential risk of ototoxicity in the foetus. There is no information available regarding the safety of this drug during breastfeeding.
","Since Amikacin is present in high concentrations in the renal excretory system, patients should be well hydrated to minimize chemical irritation of the renal tubules. If azotemia increases, treatment should be stopped. Monitoring of renal function during treatment with aminoglycosides is particularly important.
","Pediatric Use: Safety and effectiveness of Amikacin for injection in children or adolescents under 16 years have not been established
","In the event of overdose or toxic reaction, peritoneal dialysis or haemodialysis will aid in the removal of Amikacin from the blood.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",13
+53,Ambroxol Hydrochloride,ambroxol-hydrochloride-53,https://medex.com.bd/attachments/TGI6YRqCoFD4PjKmUoxUchlYMdwcrg/ambroxol-hydrochloride-prescribing-information,Cough expectorants & mucolytics,Sore throat,"This is indicated in-
+
+- Productive cough
+- Acute and chronic inflammatory disorders of upper and lower respiratory tracts associated with viscid mucus including acute and chronic bronchitis
+- Inflammatory disease of rhinopharyngeal tract (laryngitis, pharyngitis, sinusitis and rhinitis) associated with viscid mucus
... Read more
This is indicated in-
+
+- Productive cough
+- Acute and chronic inflammatory disorders of upper and lower respiratory tracts associated with viscid mucus including acute and chronic bronchitis
+- Inflammatory disease of rhinopharyngeal tract (laryngitis, pharyngitis, sinusitis and rhinitis) associated with viscid mucus
+- Asthmatic bronchitis bronchial asthma with thick expectoration
+- Bronchiectasis
+- Chronic pneumonia etc.
+
","Cough expectorants & mucolytics
","Ambroxol is the active metabolite of bromhexine and it has been proven that this metabolite possesses a greater bronchosecretolytic effect than bromhexine. It improves sputum rheology by hydrating mechanism leading to liquefaction of mucus in the lumen of respiratory tract, thus facilitating expectoration of mucus and reducing dyspnea. It stimulates production of phospholipids of surfactant by alveolar cells, thus contributing to the lowering of superficial tension in the alveoli. It also reduces bronchial hyperactivity. Ambroxol has anti inflammatory properties owing to the inhibitory effect on the production of cellular cytokines and arachidonic acid metabolites. In patients with COPD it traditionally improves airway patency.
","Average daily dose (preferably after meal):
Pediatric Drops:
+
+- 0-6 months: 0.5 ml 2 times a day
+- 6-12 months: 1 ml 2 times a day
+- 1-2 years: 1.25 ml 2 times a day
+
+Syrup:
+
+- 2-5 years: 2.5 ml (1/2 teaspoonful) 2-3 times a day
+- 5-10 years: 5 ml (1 teaspoonful) 2-3 times a day
+- 10 years and adults: 10 ml (2 teaspoonful) 3 times a day.
+
+Sustained release capsule: Adult and children over 12 years old: 1 capsule once daily.
",,"Ambroxol should not be taken simultaneously with antitussives (e.g.Codeine) because phlegm, which has been liquefied by Ambroxol might not be expectorated.
","Contraindicated in known hypersensitivity to Ambroxol or Bromhexine.
","Gastrointestinal side effects like epigastric pain, stomach overfill feeling may occur occasionally. Rarely allergic responses such as eruption, urticaria or angioneurotic edema have been reported.
","Teratogenic and fetal toxicity studies have shown no harmful effect of Ambroxol. However, it is advised not to use it in pregnancy, especially during the1st trimester. Safety during lactation has not been established yet.
","Ambroxol should be given cautiously to patients with gastric and duodenal ulceration or convulsive disorders. Patients with hepatic and renal insufficiency should take it with caution.
",,,,,"Protect from direct light exposure, Store in a dry place at a temperature not exceeding 30°C, Keep out of the reach of children.
",10
+51,Ambrisentan,ambrisentan-51,https://medex.com.bd/attachments/44AFbvjVDcDrZipQChf5DECIc4HGyY/ambrisentan-prescribing-information,Anti-hypertensive,Pulmonary arterial hypertension,"Ambrisentan is indicated for the treatment of Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise ability and delay clinical worsening.
","Anti-hypertensive, Endothelin receptor antagonist
","Endothelin-1 (ET-1) is a potent autocrine and paracrine peptide. Two receptor subtypes, ETA and ETB, mediate the effects of ET-1 in the vascular smooth muscle and endothelium. The primary actions of ETA are vasoconstriction and cell proliferation, while the predominant actions of ETB are vasodilation, antiproliferation, and ET-1 clearance. Ambrisentan is a high-affinity ETA receptor antagonist with a high selectivity for the ETA versus ETB receptor (>4000-fold). The clinical impact of high selectivity for ETA is not known.
The pharmacokinetics of Ambrisentan (S-Ambrisentan) in healthy subjects are dose proportional. The absolute bioavailability of Ambrisentan is not known. Ambrisentan is absorbed with peak concentrations occurring approximately 2 hours after oral administration in healthy subjects and PAH patients. Food does not affect its bioavailability. In vitro studies indicate that Ambrisentan is a substrate of P-gp. Ambrisentan is highly bound to plasma proteins (99%). The elimination of Ambrisentan is predominantly by non-renal pathways, but the relative contributions of metabolism and biliary elimination have not been well characterized. In plasma, the AUC of 4-hydroxymethyl Ambrisentan accounts for approximately 4% relative to parent Ambrisentan AUC. Thein vivo inversion of S-Ambrisentan to R-Ambrisentan is negligible. The mean oral clearance of Ambrisentan is 38 mL/min and 19 mL/min in healthy subjects and in PAH patients, respectively. Although Ambrisentan has a 15-hour terminal half-life, the mean trough concentration of Ambrisentan at steady-state is about 15% of the mean peak concentration and the accumulation factor is about 1.2 after long-term daily dosing, indicating that the effective half-life of Ambrisentan is about 9 hours.
","Adult dose: Initial treatment is 5 mg once daily, and can be increased to 10 mg once daily if 5 mg is tolerated. Ambrisentan may be administered with or without food.
Pediatric patients: The safety and effectiveness of Ambrisentan in pediatric patients have not been established.
",,"Multiple dose co-administration of Ambrisentan and Cyclosporine resulted in an approximately 2-fold increase in Ambrisentan exposure in healthy volunteers; therefore, limit the dose of Ambrisentan to 5 mg once daily when co-administered with Cyclosporine.
","Ambrisentan may cause fetal harm when administered to a pregnant woman. Ambrisentan is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Pregnancy must be excluded before the initiation of treatment with Ambrisentan and prevented during treatment and for one month after stopping treatment. Ambrisentan is contraindicated in patients with Idiopathic Pulmonary Fibrosis (IPF) including IPF patients with pulmonary hypertension (WHO Group 3).
","Decreases in hemoglobin concentration and hematocrit have followed administration of other endothelin receptor antagonists and were observed in clinical studies with Ambrisentan
","Pregnancy Category X. It is not known whether Ambrisentan is excreted in human milk. Breastfeeding while receiving Ambrisentan is not recommended.
","Fluid Retention: Peripheral edema is a known class effect of endothelin receptor antagonists, and is also a clinical consequence of PAH and worsening PAH.
Pulmonary Veno-occlusive Disease: If patients develop acute pulmonary edema during initiation of therapy with vasodilating agents such as Ambrisentan, the possibility of pulmonary veno-occlusive disease should be considered, and if con_rmed. Ambrisentan should be discontinued.
Hematological Changes: Decreases in hemoglobin concentration and hematocrit have followed administration of other endothelin receptor antagonists and were observed in clinical studies with Ambrisentan.
Hepatic impairment: Ambrisentan is not recommended in patients with moderate or severe hepatic impairment.
",,,,,"Store in a cool and dry place, below 30°C. Protect from light and moisture.
",10
+50,Amantadine Hydrochloride,amantadine-hydrochloride-50,https://medex.com.bd/attachments/Q4SH4DclkoERf5FrAfr3F5pRIiA5wA/amantadine-hydrochloride-prescribing-information,Respiratory viral infections (Influenza),Parkinson’s disease,"Amantadine Hydrochloride is indicated for-
+
+- Treatment of parkinsonism
+- Treatment of drug-induced extrapyramidal reactions
+- Prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus
+
","Respiratory viral infections (Influenza)
","The mechanism by which amantadine exerts its antiviral activity is not clearly understood. It appears to mainly prevent the release of infectious viral nucleic acid into the host cell by interfering with the function of the transmembrane domain of the viral M2 protein. In certain cases, amantadine is also known to prevent virus assembly during virus replication. It does not appear to interfere with the immunogenicity of inactivated influenza A virus vaccine.
Amantadine inhibits the replication of influenza A virus isolates from each of the subtypes, i.e., H1N1, H2N2 and H3N2. It has very little or no activity against influenza B virus isolates. A quantitative relationship between the in vitrosusceptibility of influenza A virus to amantadine and the clinical response to therapy has not been established in man. Sensitivity test results, expressed as the concentration of amantadine required to inhibit by 50% the growth of virus (ED50) in tissue culture vary greatly (from 0.1 µg/mL to 25.0 µg/mL) depending upon the assay protocol used, size of virus inoculum, isolates of influenza A virus strains tested, and the cell type used. Host cells in tissue culture readily tolerated amantadine up to a concentration of 100 µg/mL.
","Parkinson's disease:
+
+- Adult: Initially, 100 mg/day, increased to 100 mg bid after a wk or more. Max dose: 400 mg daily.
+- Elderly: >65 yr: Lowest effective dose.
+
+
Prophylaxis of influenza A:
+
+- Adult: 100 mg daily for up to 6 wk; when used with influenza vaccination: only up to 3 wk after vaccination.
+- Child: 10-15 yr: 100 mg daily.
+
+
Influenza A:
+
+- Adult: 100 mg daily for 5 days.
+- Elderly: >65 yr: Daily dose of 1 day.
+
+
Herpes zoster in immunocompromised patients:
+
+- Adult: 100 mg bid for 14 days, continued for another 14 days if pain persists.
+
",,"Concurrent administration of Amantadine and anticholinergic agents or levodopa may increase confusion, hallucinations, nightmares, gastro-intestinal disturbances, or other atropine-like side effects. Psychotic reactions have been observed in patients receiving Amantadine and Levodopa.
Concurrent administration of Amantadine and drugs or substances (e.g. alcohol) acting on the CNS may result in additive CNS toxicity. Close observation is recommended.
","Amantadine is contraindicated in patients with known hypersensitivity to the active substances or to any of the excipients.
","The adverse effects of Amantadine are generally mild and, when they occur, may diminish or cease after a week or more on the medication. The most commonly reported side effects include nausea, dizziness/ lightheadedness, and insomnia.
Other side effects may include edema of ankles, livedo reticularis; anxiety, elevation of mood, headache, lethargy, hallucinations, ataxia, slurred speech, blurred vision, loss of concentration, nervousness, depression, myalgia, palpitations, orthostatic hypotension, dry mouth, anorexia, constipation and diaphoresis.
","Pregnancy category C. No well-controlled studies have been done in pregnant women to evaluate Amantadine's safety. Amantadine may be used during pregnancy when the potential benefits outweigh the potential but unknown risks to the fetus.
Amantadine is excreted into breast milk in low concentrations. As no information is available on the effects in infants, therefore amantadine should be used cautiously in women who are breastfeeding.
","Amantadine should not be discontinued abruptly in patients with Parkinson's disease since a few patients have experienced a parkinsonian crisis, i.e., a sudden marked clinical deterioration, when this medication was suddenly stopped. The dose of anticholinergic drugs or of Amantadine Hydrochloride should be reduced if atropine-like effects appear when these drugs are used concurrently. Abrupt discontinuation may also precipitate delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression and slurred speech.
","Patients with renal impairment: The dose should be reduced. This can be achieved by either reducing the total daily dose, or by increasing the dosage interval in accordance with the creatinine clearance. For example:
+
+- CrCl <15 ml/min: Contraindicated
+- CrCl 15-35 ml/min: 100 mg every 2 to 3 days
+- CrCl >35 ml/min: 100mg every day
+
+
Patients with hepatic impairment: Use with caution
",,,,"Store at 20-25°C in dry place. Protect from light.
",11
+49,Alverine Citrate,alverine-citrate-49,https://medex.com.bd/attachments/2Rp4M7JyhwrjKD1rYpEdj9tkf8FFWD/alverine-citrate-prescribing-information,Anticholinergics,Spasm,"Alverine Citrate is indicated in-
+
+- Irritable Bowel Syndrome
+- Bowel movement disturbances caused by small sacs or pouches in the wall of the gut (diverticular disease)
+- Abdominal pain associated with menstrual periods (Primary dysmenorrhea)
+- Relief of other conditions associated with spasm of involuntary muscle
+
","Anticholinergics
","Alverine Citrate is a smooth muscle relaxant. Smooth muscle is a type of muscle that is not under voluntary control; it is the muscle present in places such as the gut and uterus. Alverine Citrate acts directly on the muscle in the gut, causing it to relax. This prevents the muscle spasm which occur in the gut in conditions such as irritable bowel syndrome and diverticular disease. Alverine Citrate also relaxes the smooth muscle in the uterus. It is therefore also used to treat painful menstruation, which is caused by muscle spasm in the uterus (dysmenorrhea).
","Adult: Orally: 60-120 mg 1-3 times daily.
",,"There are no drug interactions reported with this medicine.
","Paralytic ileus or known hypersensitivity to any of the ingredients.
","Possible side effects may include nausea, headache, dizziness, itching, rash and allergic reactions.
","Although no teratogenic effects have been reported, use during pregnancy or lactation is not recommended as evidence of safety in preclinical studies are limited.
","Avoid Alverine Citrate in patients with intestinal obstruction or paralytic ileus.
","Children under 12 years: Not recommended
","Can produce hypotension and atropine like-toxic effects. Management for overdose is as like as atropine poisoning with continuation of supportive therapy for hypotension.
",,,"Store in a cool and dry place, away from light. Keep all medicines out of the reach of children. Store below 25°C temperature.
",12
+1297,Aluminium Oxide + Magnesium Trisilicate,aluminium-oxide-magnesium-trisilicate-1297,,Antacid with laxative action,Peptic ulcer disease,"Aluminium Oxide & Magnesium Trisilicate is indicated in Heartburn, Indigestion, Gastric Hyperacidity, Peptic ulcer disease, Gastroesophageal reflux disorder (GERD)
","Antacid with laxative action, Antacids
","Aluminum hydroxide neutralizes stomach hydrocloride to form AICI3 salt plus water; increases gastric pH.
Magnesium Trisilicate neutralizes gastric acidity by increasing gastric pH
","Take 2-4 teaspoonful after meals and at bedtime as needed (up to 4 times a day)
",,"Aluminium Hydroxide: Enhanced absorption with citrates or ascorbic acid. Decreases absorption of allopurinol, tetracyclines, quinolones, cephalosporins, biphosphonate derivatives, corticosteroids, cyclosporin, delavirdine, Fe salts, imidazole antifungals, isoniazid, mycophenolate, penicillamine, phosphate supplements, phenytoin, phenothiazines, trientine.
Magnesium Trisilicate: None well documented.
","Hypophosphataemia
","Diarrhoea, constipation, nausea, vomiting.
","Pregnancy Category- Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
","Renal dysfunction, low phosphate diet, prolonged use.
",,,,,,9
+20,Aluminium Hydroxide + Magnesium Hydroxide + Simethicone,aluminium-hydroxide-magnesium-hydroxide-simethicone-20,,Antacids,Upper Gl bloating,"This is indicated for symptomatic relief of hyperacidity associated with the peptic ulcer, gastritis, peptic oesophagitis, gastric hyperacidity, heartburn, sour stomach or hiatus hernia. It is effective in the prevention of stress ulceration and GI bleeding. It acts as an antiflatulent to alleviate ... Read more
This is indicated for symptomatic relief of hyperacidity associated with the peptic ulcer, gastritis, peptic oesophagitis, gastric hyperacidity, heartburn, sour stomach or hiatus hernia. It is effective in the prevention of stress ulceration and GI bleeding. It acts as an antiflatulent to alleviate the symptoms of gas including post operative gas pain. This rapidly relieves acid pain, disperses gastric foam and facilitates eructation of gas and air.
","Antacids
","This is the mixture of non-systemic acid neutralizing substances and antiflatulent. This preparation offers reliability as well as long action. Aluminium Hydroxide and Magnesium Hydroxide induce the relief of ulcer by neutralizing gastric acid secreted from parietal cells of the stomach. The clinical use of simethicone is based on its antifoam properties. Simethicone spreads on the surface of aqueous liquids, forming a film of low surface tension and causing collapse of foam bubbles. Simethicone repeatedly allows mucous surrounded gas bubbles in the GI tract to coalesce and be expelled.
This is used in the treatment of flatulence and meteorism for the elimination of gas, air or foam from the gastro-intestinal tract prior to radiography and for the relief of abdominal distension and dyspepsia.
Simethicone is physiologically inert; it does not appeared to be absorbed from the GI tract to interfere with gastric secretion or absorption of nutrients. Following oral administration, the drug is excreted unchanged in the feces.
","Tablet: 1-2 tablets 1-3 hours after meal and at bed time or as directed by the physician.
Suspension: 1-2 teaspoonful 1-3 hours after meal and at bedtime or as directed by the physician.
",,"All antacids may increase or decrease the rate and/or extent of absorption of concomitantly administered oral drugs. Antacids decrease the bioavailability of theophyline, tetracycline, quinolone antibiotics, isoniazide, ketoconazole, ethambutol, some antimuscarinic drugs, benzodiazepines, phenothiazines, ranitidine, indomethacine, nitrofurantoin, fluoride, phosphate, propanolol, atenolol, digoxins, vitamins etc. Antacids increase the bioavailability of some drugs; e.g. sulphonamides, levodopa, valproic acid, enteric coated aspirin etc.
","This should not be administered in patients with renal failure or hypophosphataemia or in those who are severely debilitated. It is also contraindicated in alkalosis and hypermagnesaemia, where abdominal distention may be due to partial or complete intestinal obstruction.
","Gastrointestinal side effects are uncommon. Occasionally, if excessive amount is consumed, diarrhea, constipation or regurgitation may occur.
","It is advised to avoid antacid preparations in the first trimester of pregnancy.
","This should be used with caution in patients with kidney disease.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+19,Aluminium Hydroxide + Magnesium Hydroxide,aluminium-hydroxide-magnesium-hydroxide-19,https://medex.com.bd/attachments/2kPMLQfc4IOmpP6vG00wRbIGaMr2Ol/aluminium-hydroxide-magnesium-hydroxide-prescribing-information,Antacids,Upper Gl bloating,"Aluminium Hydroxide and Magnesium Hydroxide is indicated for Hyperacidity, peptic ulcer, gastritis, heartburn, sour stomach & dyspepsia.
","Antacids
","This drug is well-balanced combination of essential non-systemic antacids which excel in efficacy and palatability. These are dependable antacid preparations without acid rebound, constipating or cathertic effects. Both the preparations provide symptomatic relief of hyperacidity associated with heartburn, acid ingestion or sour stomach.
Aluminium hydroxide gel, a slow acting antacid and an adsorbent with prolonged effect, has high neutralizing power. Magnesium Hydroxide possesses a slow but sustained acid neutralizing property. Antacids of both tablet and suspension possess adsorbent property. They form a protecting coating over the ulcer surface facilitating its healing; thus protecting the sensitive mucosa of stomach and duodenum from further irritation.
","Tablet: Two tablets 1-3 hours after meal and at bed time or as directed by the physician.
Suspension: 2 tea spoonful 1-3 hours after meal and at bed time or as directed by the physician.
",,"This drug inhibits the absorption of following drugs: Azithromycin, cefpodoxime, ciprofloxacin, isoniazid, rifampicin, norfloxacin, ofloxacin, pivampicillin, tetracyclines, Gabapentin and phenytoin, Itraconazole, ketoconazole, Chloroquine, hydroxychloroquine and Phenothiazines.
","This is contraindicated in hypophosphataemia. It is also contraindicated in alkalosis and hypermagnesaemia where abdominal distention may be due to partial or complete intestinal obstruction.
","Long term use of any antacid results in alkaluria, which may predispose to nephrolithiasis by forming precipitation of calcium phosphate.
","It is advised to avoid antacid preparations in the first trimester of pregnancy.
","Antacids reduce the absorption of tetracycline when given concomitantly. These should not be used concomitantly
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+45,Aluminium Chloride Hexahydrate,aluminium-chloride-hexahydrate-45,,Miscellaneous topical agents,Oesophagitis,"Aluminium Chloride Hexahydrate is indicated for the treatment of excessive perspiration of the underarms, hands, feet and scalp.
","Miscellaneous topical agents
","Aluminium Chloride Hexahydrate acts locally in the stratum corneum and terminal duct to relieve hyperhidrosis. Aluminium salts cause an obstruction of the ducts of sweat glands at the skin surface. It seems that the metal (Aluminium) ions precipitate with mucopolysaccharides, damaging epithelial cells along with the duct lumen and forms a plug (gel) that blocks sweat output.
","Step 1: Apply Aluminium Chloride Hexahydrate topical solution at night after drying the affected areas carefully.
Step 2: Wash off in the morning. Do not re-apply the product during the day.
Step 3: Initially the product may be applied every night until sweating stops during the day. The frequency of application may be reduced to twice a week or less, if excess sweating is stopped during the day.
",,"There are no known drug interactions for Aluminium Chloride Hexahydrate topical solution.
","Aluminium Chloride Hexahydrate is contraindicated in patients with known hypersensitivity to any of its components.
","Aluminium Chloride Hexahydrate is normally well tolerated and adverse effects are only mild and short-lasting. But sometimes irritation of the skin like- stinging, burning, redness, swelling, tingling or itching of treated skin areas may occur. These irritations may be alleviated by use of a weak corticosteroid cream.
","There are no restrictions on the use of this medication during pregnancy and lactation.
","For external use only. Do not apply this medication to broken, irritated or recently shaved skin. Avoid contact with eyes, mouth, nose and lips. Avoid direct contact with clothing and polished metal or jewellery surfaces. Keep out of reach of children.
",,,,,"Store in a cool & dry place, protected from light. Keep out of reach of children. Keep away from naked flame. Store upright.
",10
+1829,Aluminium Chloride + Melaleuca Alternifolia Oil + Geothermal water,aluminium-chloride-melaleuca-alternifolia-oil-geothermal-water-1829,,Miscellaneous topical agents,Hyperhidrosis,"This spray is indicated for the tratment of Hyperhidrosis.
","Miscellaneous topical agents
",,"Initially apply this spray in the morning & evening after drying the affected areas carefully. The frequency of application may be reduced to twice a week or less after improving the condition.
",,,"Contraindicated in any other ingredient of this preparations.
",,,,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",5
+1499,Alteplase,alteplase-1499,https://medex.com.bd/attachments/FXfVMg4ykK5oQIlqv5zPWdxTcA8WAb/alteplase-prescribing-information,Fibrinolytics (Thrombolytics),Stroke,"Acute Ischemic Stroke: Alteplase is indicated for the treatment of acute ischemic stroke. Exclude intracranial hemorrhage as the primary cause of stroke signs and symptoms prior to initiation of treatment. Initiate treatment as soon as possible but within 3 hours after symptom onset ... Read more
Acute Ischemic Stroke: Alteplase is indicated for the treatment of acute ischemic stroke. Exclude intracranial hemorrhage as the primary cause of stroke signs and symptoms prior to initiation of treatment. Initiate treatment as soon as possible but within 3 hours after symptom onset.
Acute Myocardial Infarction: Alteplase is indicated for use in acute myocardial infarction (AMI) for the reduction of mortality and the reduction of the incidence of heart failure.
Pulmonary Embolism: Alteplase is indicated for the lysis of acute massive pulmonary embolism, defined as:
+
+- Acute pulmonary emboli obstructing blood flow to a lobe or multiple lung segments.
+- Acute pulmonary emboli accompanied by unstable hemodynamics, e.g., failure to maintain blood pressure without supportive measures.
+
","Anti-platelet drugs, Fibrinolytics (Thrombolytics)
","Alteplase is a serine protease responsible for fibrin-enhanced conversion of plasminogen to plasmin. It produces limited conversion of plasminogen in the absence of fibrin. When introduced into the systemic circulation at pharmacologic concentration, alteplase binds to fibrin in a thrombus and converts the entrapped plasminogen to plasmin. This initiates local fibrinolysis with limited systemic proteolysis.
Pharmacodynamics: Following administration of 100 mg Alteplase, there is a decrease (16%-36%) in circulating fibrinogen. In a controlled trial, 8 of 73 patients (11%) receiving Alteplase (1.25 mg/kg body weight over 3 hours) experienced a decrease in fibrinogen to below 100 mg/dL.
Pharmacokinetics: Alteplase in acute myocardial infarction (AMI) patients is rapidly cleared from the plasma with an initial half-life of less than 5 minutes. There is no difference in the dominant initial plasma half-life between the 3-hour and accelerated regimens for AMI. The plasma clearance of alteplase is 380-570 mL/min, primarily mediated by the liver. The initial volume of distribution approximates plasma volume.
","Acute Ischemic Stroke: Administer Alteplase as soon as possible but within 3 hours after onset of symptoms. The recommended dose is 0.9 mg/kg (not to exceed 90 mg total dose), with 10% of the total dose administered as an initial intravenous bolus over 1 minute and the remainder infused over 60 minutes. During and following Alteplase administration for the treatment of acute ischemic stroke, frequently monitor and control blood pressure. In patients without recent use of oral anticoagulants or heparin, Alteplase treatment can be initiated prior to the availability of coagulation study results. Discontinue Alteplase if the pretreatment International Normalized Ratio (INR) is greater than 1.7 or the activated partial thromboplastin time (aPTT) is elevated.
Acute Myocardial Infarction: Administer Alteplase as soon as possible after the onset of symptoms. The recommended total doses for acute myocardial infarction (AMI) is based on patient weight, not to exceed 100 mg, regardless of the selected administration regimen (accelerated or 3 hour). There are two Alteplase dose regimens (accelerated and 3-hour) for use in the management of AMI; there are no controlled studies to compare clinical outcomes with these regimens
Pulmonary Embolism (PE): The recommended dose is 100 mg administered by IV infusion over 2 hours. Institute parenteral anticoagulation near the end of or immediately following the Alteplase infusion when the partial thromboplastin time or thrombin time returns to twice normal or less.
","Following bolus dose, if indicated:
+
+- 50 mg vials: administer using either a polyvinyl chloride bag or glass vial and infusion set.
+- 100 mg vials: remove from the vial any quantity of drug in excess of that specified for patient treatment. Insert the spike end of an infusion set through the same puncture site created by the transfer device in the stopper of the vial of reconstituted Alteplase. Peel the clear plastic hanger from the vial label. Hang the Alteplase vial from the resulting loop.
+
+Alteplase is for intravenous administration only. Extravasation of Alteplase infusion can cause ecchymosis or inflammation. If extravasation occurs, terminate the infusion at that IV site and apply local therapy. Do not add any other medication to infusion solutions containing Alteplase.
","The interaction of Alteplase with other cardioactive or cerebroactive drugs has not been studied. Anticoagulants and antiplatelet drugs increase the risk of bleeding if administered prior to, during, or after Alteplase therapy. In the post-marketing setting, there have been reports of orolingual angioedema in patients (primarily patients with AIS) receiving concomitant angiotensin-converting enzyme inhibitors.
","Acute Ischemic Stroke: Do not administer Alteplase to treat acute ischemic stroke in the following situations in which the risk of bleeding is greater than the potential benefit [see Warnings and Precautions (5.1)]:
+
+- Current intracranial hemorrhage
+- Subarachnoid hemorrhage
+- Active internal bleeding
+- Recent (within 3 months) intracranial or intraspinal surgery or serious head trauma
+- Presence of intracranial conditions that may increase the risk of bleeding (e.g., some neoplasms, arteriovenous malformations, or aneurysms)
+- Bleeding diathesis
+- Current severe uncontrolled hypertension.
+
+
Acute Myocardial Infarction or Pulmonary Embolism: Do not administer Alteplase for treatment of AMI or PE in the following situations in which the risk of bleeding is greater than the potential benefit:
+
+- Active internal bleeding
+- History of recent stroke
+- Recent (within 3 months) intracranial or intraspinal surgery or serious head trauma
+- Presence of intracranial conditions that may increase the risk of bleeding (e.g. some neoplasms, arteriovenous malformations, or aneurysms)
+- Bleeding diathesis
+- Current severe uncontrolled hypertension.
+
","The following adverse reactions are:
+
+- Bleeding
+- Orolingual Angioedema
+- Cholesterol Embolization
+- Reembolization of Deep Venous Thrombi during Treatment for Acute Massive Pulmonary
+- Embolism.
+
","Pregnancy Category C. Alteplase is embryocidal in rabbits when intravenously administered in doses of approximately two times (3 mg/kg) the human dose for AMI. No maternal or fetal toxicity was evident at 0.65 times (1 mg/kg) the human dose in pregnant rats and rabbits dosed during the period of organogenesis. There are no adequate and well-controlled studies in pregnant women. It is not known whether Alteplase is excreted in human milk. Many drugs are excreted in human milk.
","
+- Increases the risk of bleeding. Avoid intramuscular injections. Monitor for bleeding. If serious bleeding occurs, discontinue Alteplase.
+- Monitor patients during and for several hours after infusion for orolingual angioedema. If angioedema develops, discontinue Alteplase.
+- Cholesterol embolism has been reported rarely in patients treated with thrombolytic agents.
+- Consider the risk of reembolization from the lysis of underlying deep venous thrombi in patients with pulmonary embolism.
+
","Pediatric Use: Safety and effectiveness of Alteplase in pediatric patients have not been established.
Geriatric Use:
+
+- Acute Ischemic Stroke: In exploratory, multivariate analyses of Studies 1 and 2, age greater than 77 years was one of several interrelated baseline characteristics associated with an increased risk of intracranial hemorrhage. Efficacy results suggest a reduced but still favorable clinical outcome for Alteplase-treated elderly.
+- Acute Myocardial Infarction: In a large trial of accelerated-infusion Alteplase that enrolled 41,021 patients with AMI to one of four thrombolytic regimens [see Clinical Studies (14.2)], patients over 75 years of age, a predefined subgroup, comprised 12% of enrolment. In these patients, the incidence of stroke was 4.0% for the Alteplase accelerated infusion group, 2.8% for streptokinase IV [SK (IV)], and 3.2% for streptokinase SQ [SK (SQ)]. The incidence of combined 30-day mortality or nonfatal stroke was 20.6% for accelerated infusion of Alteplase, 21.5% for SK (IV), and 22.0% for SK (SQ).
+
",,,,"Store lyophilized Alteplase at controlled room temperature not to exceed 30°C, or under refrigeration (2-8°C). Protect the lyophilized material during extended storage from excessive exposure to light. If stored between 2-30°C, Alteplase may be used within 8 hours following reconstitution. Discard any unused solution after administration is complete. Do not use beyond the expiration date stamped on the vial.
",12
+18,Alprazolam,alprazolam-18,https://medex.com.bd/attachments/hypL7MwIAu235kGcMu6FM7kH40ZuGS/alprazolam-prescribing-information,Benzodiazepine sedatives,Vestibular neuritis,"Alprazolam is indicated in-
+
+- Anxiety disorder
+- Short term relief of anxiety
+- Anxiety associated with depression
+- Panic disorder, with or without agoraphobia.
+
","Benzodiazepine sedatives
","Alprazolam is a triazole analog of the 1,4-benzodiazepine class of drugs. It is an anxiolytic with hypnotic and anticonvulsive properties. Alprazolam is presumed to produce its effects via interacting with the Gamma Aminobutyric Acid (GABA)- benzodiazepine receptor complex. Like all benzodiazepines, it causes a dose-related CNS depressant activity varying from mild impairment of task performance to hypnosis.
","Treatment should be initiated with a dose of 0.25 to 0.5 mg three times daily. Depending on the response, dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg/day. The maximum dose should not exceed 4 mg/day. Occasional patients with panic disorder may need as much as 10 mg a day to achieve a successful response and in these cases periodic reassessment and consideration of dosage adjustment is required.
Dosage should be individualized for maximum beneficial effect with the lowest possible dose. If side-effects occur at starting dose, dose may be lowered. When discontinuing therapy, dosage should be reduced gradually by no more than 0.5 mg every three days.
In elderly patients or in patients with advanced liver disease, the usual starting dose is 0.25 mg, two or three times daily and may be gradually increased if needed and tolerated.
Alprazolam 1 mg should be administered once daily, preferably in the morning by patients who are on multiple dosage regimens of Alprazolam 0.25/0.5 mg. The tablets should be taken intact, they should not be chewed, crushed, or broken.
",,"The CNS-depressant action of Alprazolam may be aggravated by concomitant use of other psychotropic drugs, anticonvulsants, antihistaminics, alcohol and oral ontraceptives.
",,"Side effects, if occur, are generally observed at the beginning of therapy and usually disappear upon continued medication. The most frequent side effects are drowsiness and light-headedness. The other side effects, that may occur include depression, headache, confusion, dry mouth, constipation, etc.
","Alprazolam has been categorized in pregnancy category D; that means, it should be avoided in pregnancy. Like other benzodiazepines, Alprazolam is assumed to be excreted in breast milk. Therefore, nursing should not be undertaken by mothers who must use Alprazolam.
","Because Alprazolam may produce psychological and physical dependence, the increment of dose or abrupt discontinuation of Alprazolam therapy should not be done without the physician's advice. The duration of therapy must be determined by the physicians. Alprazolam should be administered with caution to patients with hepatic or renal disease, chronic pulmonary insufficiency, or sleep apnea.
","The safety and effectiveness of Alprazolam in individuals below 18 years of age have not been established.
","Manifestations of Alprazolam overdosage include somnolence, confusion, impaired coordination, diminished reflexes, and coma. In such cases of overdosage general supportive measures should be employed along with immediate gastric lavage.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+1167,Alphanate,alphanate-1167,,Haemostatics,Prevention & control of bleeding in Factor VIII deficiency,"Alphanate, (antihemophilic factor/von Willebrand factor complex), is indicated for:
+
+- Control and prevention of bleeding episodes and perioperative management in adult and pediatric patients with Factor VIII(FVIII) deficiency due to hemophilia A.
+- Surgical and/or invasive procedures in adult and pediatric patients with von Willebrand Disease (VWD) in whom desmopressin (DDAVP) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery.
+
","Haemostatics
","Antihemophilic Factor/ Von Willebrand Factor Complex (Human) contains Antihemophilic Factor (FVIII) and von Willebrand Factor (VWF), constituents of normal plasma, which are required for clotting. The administration of Alphanate temporarily increases the plasma level of FVIII, thus minimizing the hazard of hemorrhage in patients with hemophilia A. FVIII is an essential cofactor in activation of factor X leading to formation of thrombin and fibrin. VWF promotes platelet aggregation and platelet adhesion on damaged vascular endothelium; it also serves as a stabilizing carrier protein for the procoagulant protein FVIII.
","Alphanate contains the labeled amount of Factor VIII expressed in International Units (IU) FVIII/vial and Willebrand.
Factor: Ristocetin Cofactor activity in IU VWF:RCo/vial.
Hemophilia A: Control and prevention of bleeding episodes
+
+- Dose (units) = body weight (kg) x desired FVIII rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL)
+- Frequency of intravenous injection of the reconstituted product is determined by the type of bleeding episode and the recommendation of the treating physician
+
+
Von Willebrand Disease: Surgical and/or invasive procedure in adult and pediatric patients except Type 3 undergoing major surgery
+
+- Adults: Pre-operative dose of 60 IU VWF:RCo/kg body weight; subsequent doses of 40-60 IU VWF:RCo/kg/body weight at 8-12 hour intervals post-operative as clinically needed.
+- Pediatric: Pre-operative dose of 75 IU VWF:RCo/kg/body weight; subsequent doses of 50-75 IU VWF:RCo/kg body weight at 8-12 hour intervals post-operative as clinically needed.
+- Dosage based on protocol used in the Alphanate prospective clinical trial according to judgment of the investigator.
+
+
Pediatric Use-
+
+- Hemophilia A Indication: Clinical trials for safety and effectiveness in pediatric hemophilia A patients 16 years of age and younger have not been conducted.
+- VWD Indication: The hemostatic efficacy of Alphanate has been studied in 20 pediatric subjects with VWD 18 years of age and under. Based on the data from a subset of these subjects, age had no effect on the pharmacokinetics of VWF:RCo. There were no clinically important differences between pediatric patients and adults.
+
+
Geriatric Use: No human or animal data. Use only if clearly needed.
","Alphanate is for intravenous use only after reconstitution. Use plastic disposable syringes. Do not refrigerate after reconstitution. Reconstituted Alphanate may be stored at room temperature (not to exceed 30° C) prior to administration, but administer intravenously within three hours.
Discard any unused contents into the appropriate safety container. Do not administer Alphanate at a rate exceeding 10 mL/minute.
","None known.
","Alphanate is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components.
","The most frequent adverse events reported with Alphanate in >5% of patients are respiratory distress, pruritus, rash, urticaria, face
edema, paresthesia, pain, fever, chills, joint pain and fatigue
","Pregnancy: No human or animal data. Use only if clearly needed
Labor and Delivery: No human or animal data. Use only if clearly needed
Nursing Mothers: No human or animal data. Use only if clearly needed
","Risk of thromboembolic events & infections. Pregnancy.
","Pediatric Use: Clinical trials for safety and effectiveness in pediatric hemophilia A patients have not been conducted. The hemostatic efficacy of Alphanate has been studied in 20 pediatric subjects with VWD 18 years of age and under. Based on the data from a subset of these subjects, age had no effect on the pharmacokinetics of VWF:RCo
Geriatric Use: No human or animal data. Use only if clearly needed
",,,,,11
+1511,Ginkgo Biloba,ginkgo-biloba-1511,,Herbal and Nutraceuticals,Intermittent claudication,"Primary uses-
+
+- Cerebral insufficiency: memory deficit, depression, attention and memory loss that occur with Alzheimer's disease and multi-infarct dementia.
+- Vertigo and tinnitus (ringing in the ear) of vascular and involutional origin.
+- Peripheral vascular disease: Improvement of pain-free walking distance in Peripheral Arterial Occlusive Disease in Stage II according to Fontaine (intermittent claudication) in a regimen of physical therapeutic measures, in particular walking exercise.
... Read more
Primary uses-
+
+- Cerebral insufficiency: memory deficit, depression, attention and memory loss that occur with Alzheimer's disease and multi-infarct dementia.
+- Vertigo and tinnitus (ringing in the ear) of vascular and involutional origin.
+- Peripheral vascular disease: Improvement of pain-free walking distance in Peripheral Arterial Occlusive Disease in Stage II according to Fontaine (intermittent claudication) in a regimen of physical therapeutic measures, in particular walking exercise.
+
+Other potential Uses-
+
+- Acute cochlear deafness.
+- Sexual dysfunction associated with SSRI use.
+- Protective action in Hypoxia.
+
","Herbal and Nutraceuticals
","Ginkgo inhibits binding of platelet-activating factor (PAF) to platelets resulting in inhibited platelet aggregation and increased blood fluidity; reduces thrombosis, improvements in cognition, working memory, short-term visual memory in dementia, short-term memory in cerebral insufficiency, social functioning in people with dementia, concentration in people with dementia, attention in people with dementia, tinnitus in people with dementia, activities of daily living (ADL) scores in people under 60 years old, mood and sleep in older individuals.
","Ginkgo Biloba 60 mg: 1 or 2 capsules daily or as advised by the physician.
Ginkgo Biloba 120 mg:1 or 2 capsules daily or as advised by the physician.
",,,"Ginkgo Biloba should only be used with caution in patients taking anticoagulant or antiplatelet agents i.e. warfarin, heparin & aspirin. It is also contraindicated in bleeding disorders due to increased bleeding potential associated with chronic use (6-12 months) or before elective surgery. Contraindicated in patients with known risk factors for intracranial hemorrhage.
","No side effects following proper administration of designated therapeutic dosages. In pooled clinical trials involving 10,000 patients, the incidence of side effects produced by Ginkgo Biloba extract was extremely small. There were few cases of headaches, dizziness, palpitation, gastrointestinal disturbances, bleeding disorders & skin hypersensitivity reactions. In higher than recommended doses, diarrhea, nausea, vomiting, restlessness, and weakness may occur.
","No Known restriction still found during use in pregnancy and lactation.
","Before taking this product, tell your doctor if you are allergic to it, have bleeding problems, seizures, convulsions or epilepsy. Ginkgo biloba may decrease the ability of blood to clot. Stop taking this product at least 2 weeks before surgery
","Ginkgo Biloba should not be used in children under 12 years.
",,,,"Keep out of the reach of children. Keep away from light and moisture. Store in a dry and cool place.
",10
+1683,Garlitab,garlitab-1683,,Herbal and Nutraceuticals,Respiratory tract infections,"Garlitab is indicated in-
+
+- Diabetes
+- Rheumatoid arthritis
+- Gout
+- Respiratory tract infection
+- Bronchitis
+- Asthma
+- Dyspepsia
+- Flatulence
+- Hypertension
+- Hypercholesterolemia
+
","Herbal and Nutraceuticals
","Garlitab is one of the most recommended unani medicine for better health and well-being, prepared with valuable herbal ingredients like Garlic (Allium sativum), Onion (Allium cepa) and other natural ingredients. Garlitab acts as prebiotic, helps to regulate blood glucose level. Garlitab dilates blood vessels, improves blood flow, decreases total cholesterol, LDL, triglycerides & increases HDL, reduces the risk of hypertension. Garlitab is very effective in respiratory tract ailments, prevents infectious diseases & inflammations. Garlitab has antioxidant property & helps to reduce the risk of cancer.
","1-2 tablet(s) 2-3 times daily or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1412,Garlic Oil,garlic-oil-1412,,Supplements & adjuvant therapy,Hypertension,"Garlic Oil is indicated in Hyperlipidemia, Atherosclerosis, Mild Hypertension
","Herbal and Nutraceuticals, Supplements & adjuvant therapy
","Garlic reduces total cholesterol (TC), serum triglycerides (TG) and elevates high density lipoproteins (HDL). It prevents platelet aggregation and thrombus formation, stimulates fibrinolysis, prolongs clotting time, reduces low density lipoprotein (LDL) oxidation. It also reduces systolic and diastolic blood pressure and attenuates age and blood pressure related increases in aortic stiffness and reduces blood glucose levels.
+
+- Steroid saponins interfere with the absorption of total and LDL cholesterol from the intestinal lumen, thereby reducing plasma cholesterol level without adversely affecting HDL levels.
+- Increases catabolism of fatty acid-containing lipids, especially triglycerides.
+- Enhances palmitate-induced inhibition of cholesterol biosynthesis.
+- Inhibits cholesterol biosynthesis at the level of b-hydroxy-b-methylglutaryl-CoA (HMG-CoA) reductase.
+- The gamma-glutamylcysteines are the compounds in garlic that may lower blood pressure, as indicated by their ability to inhibit angiotensin-converting enzyme in-vitro. Garlic modulates the production and function of both endothelium derived relaxing and constricting factors and this may contribute to its protective effect against hypoxic pulmonary vasoconstriction.
+- Garlic elicits nitric-oxide-dependent relaxation in pulmonary arteries. It increases nitric oxide through activation of nitric oxide synthase activity.
+- Fructans can inhibit adenosine deaminase in isolated cells, thus increasing adenosine and its associated blood vessel dilatory activity
+
","1 to 2 capsules daily for 8 to 18 weeks or as advised by the physician
",,"Concurrent use of garlic and antiplatelet agents and anticoagulants might increase the potential for prolonged bleeding. Blood clotting times have been reported to double in patients taking warfarin and garlic suppliments
","None known. The World Health Organization cautions against the use of garlic by patients with a known allergy to garlic and those taking warfarin
","Gastro-intestinal symptoms, changes to the flora of the intestine and allergic reactions are rare
","None known. Major sulfur containing volatiles from garlic are transmitted to breast milk leading to improved drinking habits of infants
",,,,,,"Store at a cool, dry place and away from direct sunlight. Keep the medicine out of the reach of children
",9
+1491,Flaxseed oil [Linum Usitatissimum],flaxseed-oil-linum-usitatissimum-1491,,Prostaglandin analogues,Hyperlipidemia,"Flaxseed oil (Linum Usitatissimum) is indicated in Hyperlipidemia, Constipation
","Herbal and Nutraceuticals, Prostaglandin analogues
","Flaxseed Oil contains Alpha Linolenic Acid (ALA) which contributes to the maintenance of normal blood cholesterol levels. By Increasing HDL level Flaxseed Oil helps to reduce hyperlipidemia. So if we use Flaxseed oil with other Lipid lowering agent it will be very much helpful for patient with hyperlipidemia. Moreover ALA helps to reduce infammation.
Flaxseed Oil reduces cholesterol levels by increasing prostaglandins E1 & E3 (PGE1 & PGE3), which inhibit cholesterol synthesis & stimulate cholesterol movement across cell membranes. Also reduces platelet aggregation by increasing levels of PGE1 and PGE3. Flaxseed oil stimulates bowels, binds to water, mucilage swells and stool volume increases. Facilitates passage of feces through bowel through lubrication by oil.
","One softgel capsule two to three times daily, with a meal. For easier swallowing, take with water before and during ingestion
",,,"Flaxseed Oil should be used with caution when combined with: Blood thinning medication (i.e. Warfarin, Coumadin)
","Adverse effects are rare at recommended dosages. Overdose may cause loose stool and abdominal pain
","Flaxseed oil is possibly unsafe when taken by mouth during pregnancy. Some research suggests that faxseed oil might increase the chance of premature birth when taken during the second or third trimesters of pregnancy.
",,"Use in children: Flaxseed is possibly safe for children in short-term.
",,,,"Store below 30°C. Protect from light & moisture. Keep out of reach of the children.
",9
+1722,"Fishar [Snake root, Potassium, Magnesium]",fishar-snake-root-potassium-magnesium-1722,,Herbal and Nutraceuticals,Insomnia and sleep disturbances,"This is indicated in-
+
+- Hypertension
+- Insomnia
+- Anxiety
+- Tension
+- Persistent headache
+- Epilepsy
+- Hysteria
+- Insanity
+
","Herbal and Nutraceuticals
","This is an effective medicine to normalize hypertension and anxiety. The main ingredient is Snake root (Rauwolfia serpentina), it acts as an ideal tranquilizer and anti-psychotic. This is very effective in insomnia, hysteria, epilepsy, violent mania, schizophrenia, severe persistent headache, tension and irritated conditions of CNS.
","1-2 tablet(s) twice daily or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been reported in therapeutic dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place protect from light.
",8
+1536,Fermented soy [Lactobacillus Delbrueckii],fermented-soy-lactobacillus-delbrueckii-1536,,Herbal and Nutraceuticals,Nausea,"
+- Acute and chronic gastritis
+- Digestive disorders like Anorexia, Nausea and Constipation
+- Occasional heartburn
+- Gastric and duodenal ulcers
+
","Herbal and Nutraceuticals
","Fermented soy is a natural medicine produced from fermented soybeans by specific strain Lactobacillus delbrueckii. It helps to support the digestive system and eases the occasional discomfort associated with sour stomach. Bioactive compounds of fermented soy is useful in gastric discomfort management and quick relief of gastric discomfort. Fermented soy enhances appetite, relieves nausea, vomiting & gastric acid reflux.
It also repairs gastric mucosa and reduces the incidence of stomach inflammation. Fermented soy has buffering effect on the stomach pH due to high concentration of proteins or metabolites. Fermented soy releases anti-nutritional peptides that inhibit the action of the protease enzymes on stomach lining, thus protecting gastric epithelium. It also has an down-regulating effect on the expression of pro-inflammatory cytokines that helps in the healing process of gastric ulceration. Fermented soy is also designed to address the discomfort of occasional indigestion.
","Generally 1-2 tablets three times a day before meals or as advised by the physician.
",,"Possible drug interaction is present with mono-amine oxidase inhibitors a medication use in depression.
","Known hypersensitivity to any of its active ingredients
","Well tolerated in recommended dose
","Sufficient clinical data are not available for using in pregnant and lactating women.
","Store at temperature of below 30˚C, protect from light & moisture. Keep out of reach of children.
",,,,,,9
+1766,"Fennel [Mouri, Gohkshura, Kasni]",fennel-mouri-gohkshura-kasni-1766,,Herbal and Nutraceuticals,Jaundice,"This is indicated in-
+
+- Dysuria (painful urination)
+- Acts as Diuretic
+- Renoprotective
+- Jaundice & fever
+
","Herbal and Nutraceuticals
","Mouri (Foeniculum valgare): It contains Trans-anethole (80-90%), Fenchone (1-10%), Estragole (3-10%), and volatile oil that are used as diuretic, spasmolytic. Dried fruit is useful in chest, spleen & kidney troubles. Oil from seed is used as anti-microbial.
Gohkshura (Tribulus terrestris): It contains saponins, flavone glycosides, alkaloid, fixed oil, potassium nitrate, essential oil & resin that are used in cooling, painful micturition, diuretic, antispasmotic, irritation of urinary organs. It is used as a diuretic in gout, antiseptic, anti-fungal & anti-inflammatory activity. It prevents formation of kidney stone.
Kasni (Cichorium endivia): It contains sesquiterpene lactones, chiroric acid, chlorogenic acid, isochlorogenic acid & dicaffeoyl tartaric acid. It is used as a cooling agent. It is also used fever, headache & jaundice. Root is used as a diuretic and for the treatment of kidney & liver disorders.
Khorbuj (Cucumis melo): It contains ferulic, caffeic, chlorogenic acids & cucurbitacin B & E. It is used as a cooling, nutritive, diuretic. It is used in painful discharge & suppression of urinary infection.
","Adult: 2 teaspoonful’s (10 ml) 2-3 times daily.
Children: 1 teaspoonful (5 ml) 2-3 times daily.
",,,"There is no absolute contraindication.
","There is no significant side effect associated with the use of fennel in the above mentioned therapeutic doses.
","Not recommended for use during pregnancy. There is no sufficient information for use in lactation.
",,,,,,"Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.
",8
+921,Evening primrose oil,evening-primrose-oil-921,https://medex.com.bd/attachments/Q6tlIgEi0EXVX9Y04jqNq1H7LIuWfv/evening-primrose-oil-prescribing-information,Herbal and Nutraceuticals,Premenstrual syndrome,"Evening primrose oil is indicated in:
+
+- Premenstrual syndrome symptoms (PMS)
+- Benign breast disease & cyclical mastalgia
+- Lactation
+- Atopic, allergic & neurodermatitis
+- Psoriasis
+- Hypertension
+- Rheumatoid arthritis
+- Thrombosis
+- Atopic eczema
+- Dietary aid
+- Promotes healthy skin, nourishes brittle nails & hair.
+
","Herbal and Nutraceuticals
","Improves EFA composition of plasma, erythrocytes, platelet lipids and atocopherol levels in non-diabetic persons and Type 1 diabetic patients; increase total fat and EFA contents of mother's milk; affects fatty acid composition of serum lipids and adipose tissue in men with low dihoma-gamma-linolenic acid (DGLA) levels; helps maintain normal cellular structures and in the precursor of DGLA, which is the parent of the 1-series prostanoids and as a precursor of arachidonic acid, the parent of the 2-series prostanoids.
Evening Primrose Oil supplies gamma-linolenic acid (GLA). The bioactivity of EPO is due primarily to its GLA contents. By supplying GLA, it bypasses the rate-limiting step in the metabolism of LA. After ingestion of EPO, GLA is rapidly absorbed and then converts directly to DGLA and other prostaglandin precurosors. It also acts on the prostanoids pathway.
","Atopic & Allergic Dermatitis:
+
+- Adult dosage: 1 capsule 2 times daily.
+- Children dosage: 1 capsule 1/2 times daily.
+
+
Benign Breast disease & Mastalgia: 1 capsule 2/3 times daily with or after meal.
Premenstrual Syndrome (PMS): 1 Capsule 2 times daily at morning & night with or after meal.
Rheumatoid arthritis: 1 Capsule daily Or as directed by the registered physician.
",,,"Previously it was not recommended for patients diagnosed with schizophrenia. However, a recently published analysis of clinical trials involving polyunsaturated fatty acids in the treatment of schizophrenia did not indicate a clear therapeutic or adverse effect of evening primrose oil supplements on schizophrenic patients.
","Side effects are rare at recommended dosages. Overdose may cause loose stool and abdominal pain.
","Linolenic acid, GLA and DGLA are important components of human breast milk, so it is responsible to assure that evening primrose oil may be taken while nursing. According to World Health Organization (WHO), pregnant or lactating women should get 5% of their total daily caloric intake from EFAs.
",,,,,,"Keep out of reach of children. Keep away from direct sunlight. Store below 25°C in a dry place.
",8
+1709,Espand,espand-1709,,Herbal and Nutraceuticals,Premature ejaculation,"Espand is indicated in-
+
+- Spermatorrhoea
+- Premature ejaculation
+- Excessive Nocturnal emission
+- Nervous debility
+- Sexual debility
+- General debility
+- Gonorrhoea
+
","Herbal and Nutraceuticals
","This is a unique unani medicine prepared with the various natural active ingredients, which is highly effective in the treatment of spermatorrhoea, premature ejaculation and excessive nocturnal emission. It combats sexual debility and nervous debility.
","2 tablets twice daily or as prescribed by the physicians.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1517,Emblica officinalis + Piper longum,emblica-officinalis-piper-longum-1517,,Herbal and Nutraceuticals,Vitamin C deficiency,"This syrup is indicated in vitamin C deficiency, scurvy, gastritis and anemia. It also acts as an antioxidant and prevents aging and premature graying of hair, supports cardiovascular health and wellness.
Other beneficial usage: For the treatment of infection, healing of ulcers, burn and ... Read more
This syrup is indicated in vitamin C deficiency, scurvy, gastritis and anemia. It also acts as an antioxidant and prevents aging and premature graying of hair, supports cardiovascular health and wellness.
Other beneficial usage: For the treatment of infection, healing of ulcers, burn and trauma, quick healing of fracture. It is especially valuable in tuberculosis of lungs, asthma and bronchitis. Vitamin C may also be useful in lowering serum uric acid levels resulting in a correspondingly lower incidence of gout.
","Herbal and Nutraceuticals
","This is the highest quality and most potent Amla syrup, which is time-tested and proven to be clinically effective.
Emblica officinalis: Emblica officinalis is highly nutritious and is an important dietary source of vitamin C, minerals and amino acids. It contains Emblicanin A & B, Puniglucanin, Pedunculagin, 2-keto-gluconolactone (vitamin-C equivalents), ellagic acid, hexahydroxy-diphenic acid and conjugates. In addition, the fruit contains phenols including gallic acid, quercetin, kaempferol, corilagin. A tannin containing gallic acid, ellagic acid and glucose in its molecule are naturally present in the fruit, which prevent the oxidation of vitamin and renders fruit valuable in vitamin C.
The presence of flavonoids in the E. officinalis enables them to be used as an antioxidant. It counteracts the toxic effects of prolonged exposure to environmental heavy metals. It increases glutathione (GSH) levels and glutathione peroxidase (GPx) activity in macrophages and decreases free radical production.E.officinalis is also used to detoxify blood from chemicals and harmful toxic substances and this is due to presence of phenols in E. officinalis, because phenols act as a detoxifying agent. Terpenoids of E. officinalis improves lung function.
Piper longum: Piper longum is certainly one of the most widely used of all Ayurvedic herbs for enhancing digestion, assimilation and metabolism of the foods that we eat. It is also highly prized for its ability to enhance the assimilation and potency of herbs. In a study, antiulcerogenic activity of Piper longum was noted against gastric ulcer.
","Children under 12 years: 1 teaspoonful (5 ml) two times daily.
Adult: 1-2 teaspoonfuls (5-10 ml) 2-3 times daily.
",,"There is no known interaction with other drugs.But large dose of vitamin C may interfere with the absorption and metabolism of vitamin B12.
","There is no evidence available on contraindication but it may happen in patients who are hypersensitive to any of its ingredients.
","There is no known significant side effect.
","No adverse effect of this syrup has been reported. In a study conducted in animals during the first month of pregnancy, high doses of vitamin C suppresed the production of progesterone from the corpus luteum. So caution should be taken in first month of pregnancy.
","Caution is advised when taking vitamin C and agents that may damage the kidneys due to an increased risk of kidney failure.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+1700,Emblic Myrobalan + Sesame,emblic-myrobalan-sesame-1700,,Herbal and Nutraceuticals,Insomnia and sleep disturbances,"This hair oil is indicated in-
+
+- Tyroma
+- Graying of hair
+- Dandruff
+- Insomnia
+
","Herbal and Nutraceuticals
","This hair oil is an excellent tonic for hair. It strengthens the hair roots and prevents falling of hair, maintains the natural color and makes them shiny. It also imparts a cooling effect of head, promotes the hair growth and makes the hair silky, luxuriant, soft, dark and lustrous.
","Gently massage sufficient quantity of oil on dry scalp & hair.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper usage.
",,,,,,,"Store at cool and dry place, protect from light.
",7
+1739,Emblic Myrobalan + Chebulic + Belleric,emblic-myrobalan-chebulic-belleric-1739,,Herbal and Nutraceuticals,Indigestion,"This is indicated in-
+
+- Constipation
+- Anorexia
+- Indigestion
+- Diabetes
+- Skin diseases
+- Hypertension
+- Blood impurities
+- Hypercholesterolaemia
+
","Herbal and Nutraceuticals
","This is the combination of Emblic Myrobalan (Phyllanthus emblica), ChebulicMyrobalan (Terminalia chebula) & Belleric Myrobalan (Terminalia bellerica ). It is highly effective in indigestion, diabetes, constipation and anorexia. It is a tonic for all vital organs of the body.
","1 sachet 2-3 times daily with 1 cup of hot water or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Protect from light. Keep in cool & dry place. Shake well before use.
",8
+1738,Emblic Myrobalan + Aswagandha + Grape,emblic-myrobalan-aswagandha-grape-1738,,Herbal and Nutraceuticals,Malnutrition,"
+- It improves the immunity.
+- It a powerful antioxidant.
+- It effective in cough, bronchitis, asthma and tuberculosis.
+- It effective in malnutrition and degenerative diseases.
+- It improves memory.
+
","Herbal and Nutraceuticals
",,"Adults: 1-2 teaspoonful(s) twice daily.
Children: 1/2 teaspoon twice daily or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",7
+1685,Ejaz,ejaz-1685,,Herbal and Nutraceuticals,Tonsillitis,"Ejaz is indicated in-
+
+- All types of cough (dry cough, smokers cough, hacking cough, whooping cough, tubercular cough, allergic cough)
+- Common cold
+- Congestion of lungs
+- Bronchitis & tonsillitis
+- Bronchial asthma
+- Hoarseness of voice
+- Sore throat
+- Influenza.
+
","Herbal and Nutraceuticals
","Ejaz is a unique combination of valuable medicinal plants for all types of cough and cold. The major ingredients of this preparation are Vasaka (Adhatoda vasica) and Licorice (Glycyrrhiza glabra). Vasaka contains vasicine, which has expectorant, bronchodilator, antitussive, mucolytic and anti-allergic properties. Licorice contains glycyrrhizic acid, which inhibits the secretion of histamine and acts as an antiallergic agent. Ejaz is a safe and an effective, well tolerated and non-sedative for both adults and children.
","Adults: 2-4 teaspoonfuls 2-4 times daily.
Children: 1-2 teaspoonful(s) 2-4 times daily or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place protect from light.
",8
+1512,Echinacea,echinacea-1512,,Herbal and Nutraceuticals,To develop immune system,"Echinacea is used to treat common cold, cough, bronchitis and other upper respiratory tract infections, fever & cold, stimulate the immune system to prevent the tendency of infection.
","Herbal and Nutraceuticals
","Echinacea products contain a variety of bioactive ingredients including echinacosides, caffeic acids, alkylamides, polysaccharides, and glycoproteins. Though several echinacea products are standardized to the amount of echinacosides, there is no general consensus on the active component of echinacea responsible for its purported medicinal properties.
In vitro, echinacea causes macrophage activation and the release of tumor necrosis factor, interleukin 1, interleukin 6, and interferon. Echinacea has been noted to have antiviral activity against influenza, herpes, and poliovirus. Phenolic compounds present in echinacea demonstrate antioxidant activity. It has also been reported to have antiinflammatory activity through inhibition of lipoxygenase and cyclooxygenase and is able to stimulate the anterior pituitary-adrenal cortex.
","The dose is 1-2 capsule 3 times daily.
",,,,"Echinacea is generally safe for most people. Some side effects have been reported such as fever, nausea, vomiting, diarrhea, dry mouth, headache, dizziness, joint and muscle aches.
","Echinacea is not recommended for use during pregnancy.
","The drug should be used cautiously in patients with autoimmune disease
",,,,,"Echinacea capsule should be stored at room temperature. Protect from moisture and light.
",8
+1775,Amorolfine Hydrochloride (Nail Lacquer),amorolfine-hydrochloride-nail-lacquer-1775,https://medex.com.bd/attachments/yafvxMwPQ8MkUGAtkbnUs2WlN4qo6t/amorolfine-hydrochloride-nail-lacquer-prescribing-information,Other preparations,Onychomycosis,"This is indicated in onychomycosis caused by dermatophytes, yeasts and moulds.
","Other preparations
","Amorolfine is a topical antimycotic. It belongs to a new chemical class of Morpholine, Its fungistatic or fungicidal effect is based on an alteration of the fungal cell membrane targeted primarily on sterol biosynthesis. Amorolfine has a broad spectrum of action. Amorolfine is effective against Yeasts. Dermatophytes. Moulds, Dematiaceae and Dimorphic Fungi.
","Amorolfine Nail Lacquer should be applied to the affected finger or toenails once or twice a week as directed by the doctor It is important to use Amorolfine until the infection has cleared and healthy nails have grown back usually takes 6 months for fingernails and 9 to 12 months for toenails.
","Step 1: File the nail: First file down the infected areas of nail including the nail surface, as much as possible using the nail file provided. Do not use this all file on healthy nails, otherwise the infection will be spread out Discard the nail file after use.
Step 2: Clean the nail: Use one of the alcohol pads provided to clean the nail surface. Repeat steps 1 and 2 for each affected nail.
Step 3: Take some lacquer from the bottle: Use a nail brush to apply the nail lacquer. The lacquer must not be wiped off the edge of the bottle before it is applied. Do not use the brush on healthy nails and wash the brush with hot water after use
Step 4: Apply the lacquer: Apply the lacquer evenly over the entire surface of the nail. Repeat these steps for each affected nail. Let the treated nail(s) dry for approximately 3 minutes. Close the nail lacquer bottle tightly. Dispose of the alcohol pad.
+
+- Before using the nail lacquer again, first remove the old lacquer from your nails using a swab, then file down the nails again if necessary.
+- Re-apply the lacquer as previously described
+- When dry, the nail lacquer is unaffected by soap and water. So you may wash your hands and feet as normal.
+
","There are no known drug interactions.
","Must not be reused by patients who have shown hypersensitivity to the treatment.
","
+- Rare side-effects (occurring in less than 1 in 1000 people)- Nail may become discolored broken or brittle.
+- Very rare side-effects (occurring in less than 1 in 10000 people)- A burning sensation or allergic skin reaction (contact dermatitis)
+- Unknown frequency of occurrence-Skin redness, itching hives, blisters and allergic skin reaction (contact dermatitis).
+
","No data available on the use of Amorolfine in pregnant women. There is no information on whether Amorolfine passes into human breast milk. There are no data on the use of Amorolfine in lactating women.
","
+- Avoid the lacquer coming into contact with the eyes, ears or mucous membranes (eg. mouth and nostrils).
+- Do not inhale
+- Wear impermeable gloves when using organic solvents to stop the ball lacquer from being removed.
+
",,"No information is available concerning over dosage in human.
",,,"Do not store above 30°C. Protect Clinell lacquer from heat. Keep the bottle tightly closed.
",12
+1648,Amorolfine Hydrochloride (cream),amorolfine-hydrochloride-cream-1648,https://medex.com.bd/attachments/ZlSCowwWjwPEoHiSDCr9aVCoiLo9xv/amorolfine-hydrochloride-cream-prescribing-information,Topical Antifungal preparations,Tinea corporis (ringworm),"Amorolfine Hydrochloride is indicated in Dermatomycoses caused by dermatophytes: tinea pedis (athlete's foot), tinea cruris, tinea inguinalis, tinea corporis, tinea manuum. Pityriasis versicolor.
","Topical Antifungal preparations
","Amorolfine is a topical antimycotic. Amorolfine belongs to a new chemical class, and its fungicidal action is based on an alteration of the fungal cell membrane targeted primarily on sterol biosynthesis. The ergosterol content is reduced, and at the same time unusual sterically nonplanar sterols accumulate.
","Adult: To be applied to affected skin areas once daily following cleansing (in the evening). The treatment should be continued without interruption until clinical cure, and for 3-5 days thereafter. The required duration of treatment depends on the species of fungi and on the localisation of the infection. In general, treatment should be continued for at least two to three weeks. With foot mycoses, up to six weeks of therapy may be necessary.
Elderly: There are no specific dosage recommendations for use in elderly patients.
Children: There are no specific dosage recommendations for children owing to the lack of clinical experience available to date.
",,"There are no specific studies involving concomitant treatment with other topical medicines. Use of nail varnish or artificial nails should be avoided during treatment.
","Amorolfine cream must not be reused by patients who have shown hypersensitivity to the active substance or to any of the excipients.
","Side effects are Skin Irritation, erythema, pruritus, skin burning sensation, Hypersensitivity (systemic allergic reaction).
","No experience exists of use during pregnancy and nursing, therefore, the use of Amorolfine should be avoided during pregnancy and lactation. Reproductive toxicology studies showed no evidence of teratogenicity in laboratory animals but embryotoxicity was observed at high oral doses. The systemic absorption of amorolfine during and after topical administration is very low and therefore the risk to the human foetus appears to be negligible. Amorolfine Cream should not be used during pregnancy and/or lactation unless clearly necessary. Breast-feeding women must not use the cream in the breast area.
","Avoid contact of Amorolfine cream with eyes, ears and mucous membranes. This medicinal product contains stearyl alcohol which may cause local skin reaction (e.g. contact dermatitis) Owing to the lack of clinical experience available to date, the use of Amorolfine 0.25% cream in children is not recommended. A systemic or local allergic reaction could possibly occur after use of this product. If this happens, the product should be stopped immediately and medical advice should be sought. Remove the product carefully by cleaning the skin. The product should not be reapplied.
",,"Amorolfine is for topical use. In the event of accidental oral ingestion, an appropriate method of gastric emptying may be used.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+67,Amlodipine Besilate + Valsartan,amlodipine-besilate-valsartan-67,https://medex.com.bd/attachments/G4h1dZRZ2PfWSKESzD00cAaGgdCZXK/amlodipine-besilate-valsartan-revised-april-2007-prescribing-information,Combined antihypertensive preparations,Hypertension,"Amlodipine and Valsartan combination is indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension.
","Combined antihypertensive preparations
","Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of Angiotensin II by selectively blocking the binding of Angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for Angiotensin II synthesis. Amlodipine and Valsartan have been shown to be effective in lowering blood pressure. Both Amlodipine and Valsartan lower blood pressure by reducing peripheral resistance, but calcium influx blockade and reduction of Angiotensin II vasoconstriction are complementary mechanisms.
","Treatment of hypertension: Amlodipine is an effective treatment of hypertension in once daily doses of 2.5 mg - 10 mg while Valsartan is effective in doses of 80 mg-320 mg. In clinical trials with Amlodipine and Valsartan, using amlodipine doses of 5 mg-10 mg and Valsartan doses of 160 mg-320 mg, the antihypertensive effects increased with increasing doses. The majority of the antihypertensive effect is attained within 2 weeks after initiation of therapy or a change in dose. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of 10/320 mg once daily as needed to control blood pressure. This combination may be administered with or without food. This combination may be administered with other antihypertensive agents. A patient whose blood pressure is not adequately controlled with Amlodipine alone or with Valsartan alone may be switched to this combination therapy.
Elderly patients: Because of decreased clearance of Amlodipine, therapy should usually be initiated at 2.5 mg.
Renal Impairment: No initial dosage adjustment is required for patients with mild or moderate renal impairment. Titrate slowly in patients with severe renal impairment.
Hepatic Impairment: No initial dosage adjustment is required for patients with mild or moderate liver insufficiency. Titrate slowly in patients with hepatic impairment.
",,"No drug interaction studies have been conducted with Amlodipine and Valsartan combination, although studies have been conducted with the individual components.
","This combination product is contraindicated in patients who are hypersensitive to any components of this product.
","Generally been mild and transient in nature. The most common side effects include peripheral edema, nasal congestion, sore throat and discomfort when swallowing, upper respiratory tract infection, dizziness etc.
","Pregnancy Category D. It is not known whether Amlodipine or Valsartan is excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
","Avoid fetal or neonatal exposure, assess for hypotension, warn patients with severe obstructive coronary artery disease about the risk of myocardial infarction or increased angina, titrate slowly in patients with impaired hepatic or severely impaired renal function.
","Safety and effectiveness in paediatric patients have not been established.
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+66,Amlodipine Besilate + Telmisartan,amlodipine-besilate-telmisartan-66,https://medex.com.bd/attachments/30ECvmHSJ3OpPg3E4GFjQl6cJkuPpm/amlodipine-besilate-telmisartan-prescribing-information,Combined antihypertensive preparations,Hypertension,"This is indicated for the treatment of hypertension, alone or with other antihypertensive agents. It may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.
","Combined antihypertensive preparations
","This is a fixed dose combination of Telmisartan and Amiodipine. Telmisartan, a non-peptide angiotensin receptor blocker (ARB), is specific angiotensin II antagonist acting on the AT1 subtype. Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium, which leads to an increase in blood pressure (hypertension). Telmisartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Therefore, Telmisartan dilates blood vessels and reduces blood pressure without affecting pulse rate. Telmisartan has much greater affinity (>3,000 fold) for the AT1 receptor than for the AT2 receptor. It does not bind or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Amiodipine, a dihydropyridine calcium-channel blocker (CCB), inhibits the transmembrane influx of calcium ion into vascular smooth muscle and cardiac muscle. Amiodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
","Initial Therapy: Patient may be initiated on this tablets if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose is 40/5 mg once daily. Patients requiring larger blood pressure reductions may be started with 80/5 mg once daily. Initial therapy with this is not recommended in patients 575 years old or with hepatic impairment.
Add-on Therapy: Patients not adequately controlled with amiodipine (or another dihydropyridine calcium channel blocker) alone or with telmisartan (or another angiotensin receptor blocker) alone. Patients treated with 10 mg amiodipine who experience adverse reactions such as edema, may be switched to this 40/5 mg tablets once daily, reducing the dose of amiodipine without reducing the overall expected antihypertensive response.
Replacement Therapy: Patients receiving amiodipine and telmisartan from separate tablets may instead receive this tablets containing the same component doses once daily. Dosage must be individualized and may be increased after at least 2 weeks. The maximum recommended dose of this tablet is 80/10 mg once daily.
",,"Co-administration of telmisartan did not result in a clinically significant interaction with acetaminophen, amiodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. Telmisartan is not metabolized by the cytochrome P450 system and had no effects in vitro on cytochrome P450 enzymes, except for some inhibition of CYP2C19.
Telmisartan is not expected to interact with drugs that inhibit or are metabolized by cytochrome P450 enzymes, except for possible inhibition of the metabolism of drugs metabolized by CYP2C19.
In clinical trials, amiodipine has been safely administered with thiazide diuretics, beta-blockers, angiotensin converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, non-steroidal anti inflammatory drugs, antibiotics, and oral hypoglycemic drugs.
The following have no clinically relevant effects on the pharmacokinetics of amiodipine: cimetidine, grapefruit juice, sildenafil. Amiodipine has no clinically relevant effects on the pharmacokinetics or pharmacodynamics of the following: atorvastatin, digoxin, warfarin.
","
+- Known hypersensitivity to this product or any of its components.
+- Pregnancy & lactation.
+- Biliary obstructive disorders, severe hepatic impairment, hypotension, cardiogenic shock, left ventricle outflow tract obstruction.
+
","Dizziness, peripheral edema, migraine, headache, paraesthesia, vertigo, bradycardia, palpitations, hypotension, cough, abdominal pain, diarrhea, nausea, pruritus, myalgia, spasm, erectile dysfunction,chest pain, fatigue, edema etc.
","Pregnancy Categories C (first trimester) and D (second and third trimesters). It is not known whether telmisartan and amiodipine is excreted in human milk. Because of the potential for adverse effects on the nursing infant, discontinue nursing or discontinue the drug after taking into account the importance of the drug to the mother.
","
+- Avoid fetal or neonatal exposure
+- Hypotension: Correct any volume or salt depletion before initiating therapy. Observe for signs and symptoms of hypotension
+- Titrate slowly in patients with hepatic or severe renal impairment
+- Heart failure: Monitor for worsening
+- Avoid concomitant use of an ACE inhibitor and angiotensin receptor blocker
+- Myocardial infarction: Uncommonly, initiating a CCB in patients with severe obstructive coronary artery disease may precipitate myocardial infarction or increased angina.
+
","Pediatric use: Safety and effectiveness of Telmisartan & Amiodipine combination in pediatric patients have not been established.
Geriatric use: Initial therapy with Telmisartan & Amiodipine combination is not recommended in patients ≥75 years old.
Hepatic impairment: Initial therapy with Telmisartan & Amiodipine combination is not recommended in hepatically impaired patients.
","Telmisartan: Limited data are available with regard to overdosage in humans. The most likely manifestations of over dosage with telmisartan tablets would be hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by hemodialysis.
Amiodipine: Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly reflex tachycardia. If massive overdose occur, active cardiac and respiratory monitoring should be instituted. Frequent bipod pressure measurements are essential. If hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. If hypotension remains unresponsive to these conservative measures, administration of vasopressors (such as phenylephrine) should be considered with attention to circulating volume and urine output. Amiodipine is not removed by hemodialysis.
",,,"Do not store above 30°C. Protect from light and high humidity. Keep out of the reach of children.
",12
+65,Amlodipine Besilate + Olmesartan Medoxomil,amlodipine-besilate-olmesartan-medoxomil-65,https://medex.com.bd/attachments/BxFVQTFltVxeNWaLhU93m71T4Eg6pQ/amlodipine-besilate-olmesartan-medoxomil-prescribing-information,Combined antihypertensive preparations,Hypertension,"Indicated for the treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. This combination drug is indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals. The decision to use a combination ... Read more
Indicated for the treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. This combination drug is indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals. The decision to use a combination as initial therapy should be individualized and shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.
","Combined antihypertensive preparations
","Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine has a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
","Substitute individually titrated components for patients on Amlodipine and Olmesartan Medoxomil. This combination may also be given with increased amounts of Amlodipine, Olmesartan Medoxomil, or both, as needed.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
",,"The antihypertensive effect of angiotensin II receptor antagonists, including Olmesartan Medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors. Blood pressure, renal function and electrolytes should be closely monitored in patients on combination therapy and other agents that affect the RAS.
","Cannot be co-administered with Aliskiren in patients with diabetes.
","The most common side effects include peripheral edema, headache, flushing, and dizziness. It can also cause Intestinal problems known a sprue-like enteropathy.
","Pregnancy Category D. Amlodipine and Olmesartan Medoxomil combination should not be used in 2nd and 3rd trimester because it can cause fetal death. When pregnancy is detected this combination should be discontinued as soon as possible. It is not known whether Olmesartan and Amlodipine are excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
","Amlodipine and Olmesartan Medoxomil combination should be used with caution because there is a risk for-
+
+- Hypotension in volume- or salt depleted patients.
+- Vasodilation in patients with severe aortic stenosis.
+- Increased frequency, duration or severity of angina or acute Ml in patients with severe obstructive coronary artery disease.
+
","Pediatric use: The safety and effectiveness have not been established in pediatric patients.
Geriatric use: No overall differences in safety or effectiveness were observed between subjects 65 years of age or older and younger subjects.
Renal impairment: There are no studies in patients with renal impairment.
Hepatic impairment: Initial therapy is not recommended in hepatically impaired patients.
","There is no information on over dosage in humans.
",,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",12
+64,Amlodipine Besilate + Benazepril Hydrochloride,amlodipine-besilate-benazepril-hydrochloride-64,https://medex.com.bd/attachments/tPDbL4QiqD59GpYBTPX2SdHn1CjXV9/amlodipine-besilate-benazepril-hydrochloride-prescribing-information,Combined antihypertensive preparations,Hypertension,"This combination is indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension.
","Combined antihypertensive preparations
","The combination of Amlodipine and Benazepril is used to treat high blood pressure. Benazepril and benazeprilat inhibit angiotensin-converting enzyme (ACE) in human subjects and in animals. While the mechanism through which Benazepril lowers blood pressure is believed to be primarily suppression of the renin-angiotensin aldosterone system, Benazepril has an antihypertensive effect even in patients with low-renin hypertension. Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
The rate and extent of absorption of Benazepril and Amlodipine are not significantly different, respectively, from the rate and extent of absorption of Benazepril and Amlodipine from individual tablet formulations. Following oral administration of this capsule, peak plasma concentrations of Benazepril are reached in 0.5-2 hours. Peak plasma concentrations of Amlodipine are reached 6-12 hours after administration of this capsule; the extent of absorption is 64%-90%. Over 700 patients received Benazepril/Amlodipine once daily in five double-blind, placebo-controlled studies. Benazepril/Amlodipine lowered blood pressure within 1 hour, with peak reductions achieved 2-8 hours after dosing. The antihypertensive effect of a single dose persisted for 24 hours. Once-daily doses of Benazepril/Amlodipine using Benazepril doses of 10-20 mg and Amlodipine doses of 2.5-10 mg decreased seated pressure (systolic/diastolic) 24 hours after dosing by about 10-25/6-13 mmHg.
","Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5-10 mg while Benazepril is effective in doses of 10-80 mg.
It is usually appropriate to begin therapy with this capsule only after a patient has either-
+
+- Failed to achieve the desired antihypertensive effect with one or the other monotherapy, or
+- Demonstrated inability to achieve adequate antihypertensive effect with Amlodipine therapy without developing edema.
+
+
Dose Titration Guided by Clinical Effect: A patient whose blood pressure is not adequately controlled with Amlodipine (or another dihydropyridine) alone or with Benazepril (or another ACE inhibitor) alone may be switched to combination therapy with this capsule. All patient groups benefit from the reduction in Amlodipine-induced edema. Dosage must be guided by clinical response; steady-state levels of Benazepril an Amlodipine will be reached after approximately 2 and 7 days of dosing respectively.
In patients whose blood pressures are adequately controlled with Amlodipine but who experience unacceptable edema, combination therapy may achieve similar (or better) blood-pressure control without edema. Especially in nonblacks, it may be prudent to minimize the risk of excessive response by reducing the dose of Amlodipine as Benazepril is added to the regimen.
Replacement Therapy: For convenience, patients receiving Amlodipine and Benazepril from separate tablets may instead wish to receive this capsule containing the same component doses. In small, elderly, or hepatically impaired patients, the recommended initial dose of Amlodipine, as monotherapy or as a component of combination therapy, is 2.5 mg.
",,"Diuretics: Patients on diuretics, especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with Benazepril/Amlodipine.
Potassium Supplements and Potassium-Sparing Diuretics: Benazepril can attenuate potassium loss caused by thiazide diuretics. Potassium-sparing diuretics (Spironolactone, Amiloride, Triamterene and others) or potassium supplements can increase the risk of hyperkalemia. If concomitant use of such agents is indicated, they should be given with caution, and the patient's serum potassium should be monitored frequently.
Others: Benazepril has been used concomitantly with oral anticoagulants, beta-adrenergic-blocking agents, calcium-blocking agents, Cimetidine, diuretics, Digoxin, Hydralazine, and Naproxen without evidence of clinically important adverse interactions.
In clinical trials, Amlodipine has been safely administered with thiazide diuretics, beta blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, Digoxin, Warfarin, nonsteroidal anti-inflammatory drugs, antibiotics, and oral hypoglycemic drugs.
","This capsule is contraindicated in patients who are hypersensitive to Benazepril, to any other ACE inhibitor, or to Amlodipine.
","Benazepril/Amlodipine has been evaluated for safety in patients with hypertension for at least 6 months and more than 1 year. The reported side effects were generally mild and transient, and there was no relationship between side effects and age, sex, race or duration of therapy. Discontinuation of therapy due to side effects was required in approximately 4% of patients treated with Benazepril/Amlodipine and in 3% of patients treated with placebo. The most common reasons for discontinuation of therapy with Benazepril/Amlodipine in U.S. studies were cough and edema. The side effects considered possibly or probably related to study drug that occurred in U.S. placebo-controlled trials in more than 1% of patients treated with Benazepril/Amlodipine are cough, headache, dizziness and edema.
The incidence of edema was statistically greater in patients treated with Amlodipine monotherapy than in patients treated with the combination. Edema and certain other side effects are associated with Amlodipine monotherapy in a dose-dependent manner, and appear to affect women more than men. The addition of Benazepril resulted in lower incidences as shown in study; the protective effect of Benazepril was independent of race and (within the range of doses tested) of dose.
Other rare side effects are angioedema, asthenia, fatigue, insomnia, nervousness, anxiety, tremor, decreased libido, flushing, hot flashes, rash, skin nodule, dermatitis, dry mouth, nausea, abdominal pain, constipation, diarrhea, dyspepsia, esophagitis, hypokalemia, pharyngitis etc.
","Pregnancy Categories C (first trimester) and D (second and third trimesters). ACE inhibitors can cause fetal and neonatal morbidity and death when administered to pregnant women. Several dozen cases have been reported in the world literature. When pregnancy is detected, this capsule should be discontinued as soon as possible. Minimal amounts of unchanged Benazepril and of benazeprilat are excreted into the breast milk of lactating women treated with Benazepril, so that a newborn child ingesting nothing but breast milk would receive less than 0.1% of the maternal doses of Benazepril and benazeprilat. It is not known whether Amlodipine is excreted in human milk. In the absence of this information, it is recommended that nursing be discontinued while this capsule is administered.
","Impaired Renal Function: This capsule should be used with caution in patients with severe renal disease.
Hyperkalemia: This may occur in only a few patients but generally are reversible.
Patients With Hepatic Failure: Since Amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t ½) is 56 hours in patients with impaired hepatic function, caution should be exercised when administering this capsule to patients with severe hepatic impairment.
Cough: ACE inhibitor-induced cough should be considered in the differential diagnosis of cough.
Surgery/Anesthesia: In patients undergoing surgery or during anesthesia with agents that produce hypotension, Benazepril will block the angiotensin II formation that could otherwise occur secondary to compensatory renin release. Hypotension that occurs as a result of this mechanism can be corrected by volume expansion.
Carcinogenesis, Mutagenesis, Impairment of Fertility: No evidence of carcinogenicity, mutagenicity or impairment of fertility was found when the Benazepril/Amlodipine combination were given orally.
","Geriatric Use: Clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
","Human overdoses with any combination of Amlodipine and Benazepril have not been reported. In scattered reports of human overdoses with Benazepril and other ACE inhibitors, there are no reports of death.
",,,"Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+68,Amlodipine Besilate + Atorvastatin,amlodipine-besilate-atorvastatin-68,https://medex.com.bd/attachments/yZwNAO4mSE9xtYul4QOAAkQGF5Rfeh/amlodipine-besilate-atorvastatin-prescribing-information,Anti-anginal & lipid lowering drugs,Stroke,"Patients in whom treatment with Amlodipin and Atorvastatin is appropriate at the dose presented, which include hypertension, chronic stable angina, an adjunct to diet for hypercholesterolemia and in hypertensive patients with multiple risk factors for CHD to reduce the risk of nonfatal MI and nonfatal ... Read more
Patients in whom treatment with Amlodipin and Atorvastatin is appropriate at the dose presented, which include hypertension, chronic stable angina, an adjunct to diet for hypercholesterolemia and in hypertensive patients with multiple risk factors for CHD to reduce the risk of nonfatal MI and nonfatal stroke.
Amlodipine:
+
+- Hypertension: Amlodipine is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents;
+- Coronary Artery Disease (CAD): Chronic Stable Angina: Amlodipine is indicated for the treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal or antihypertensive agents; Vasospastic
+- Angina (Prinzmetal's or Variant Angina): Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal drugs.
+- Angiographically Documented CAD: In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, Amlodipine is indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure.
+
+
Atorvastatin: Atorvastatin is indicated as an adjunct to diet to reduce elevated total cholesterol, LDL- cholesterol, apolipoprotein B and triglyceride levels in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types lla and llb), adjunctive therapy to diet for the treatment of patients with elevated serum triglyceride levels (Fredrickson Type IV), for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet, to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. At the time of hospitalization for an acute coronary event, consideration can be given to initiating drug therapy at discharge if the LDL-C level is >100 mg/dL (NCEP-ATP III). Prior to initiating therapy with Atorvastatin, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, and alcoholism) should be excluded, and a lipid profile performed to measure total-C, LDL-C, HDL-C, and TG.
","Anti-anginal & lipid lowering drugs
","It is a combination product containing Amlodipine Besilate BP equivalent to 5 mg Amlodipine, a calcium channel blocker and Atorvastatin calcium INN equivalent to 10 mg Atorvastatin, a statin (HMG-CoA reductase inhibitor). Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. Atorvastatin calcium is a synthetic lipid-lowering agent. It is an inhibitor of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA). This enzyme catalyzes the conversion of HMG-CoAto mevatonate, an early and rate limiting step in the synthesis of cholesterol.
","Amlodipine: The usual initial antihypertensive oral dose is 5 mg once daily with a maximum dose of 10 mg once daily. Elderly individuals or patients with hepatic insufficiency may be started on 2.5 mg once daily dose and this dose may be used when adding Amlodipine to other antihypertensive therapy. Dosage should be adjusted according to each patient's need. The recommended dose for chronic stable or vasospastic angina is 5-10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency.
Atorvastatin:
+
+- The patient should be placed on a standard cholesterol-lowering diet before receiving Atorvastatin and should continue on this diet during treatment with Atorvastatin Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb): The recommended starting dose of Atorvastatin is 10 mg daily. The dosage range is 10 to 80 mg once daily. Atorvastatin can be administered as a single dose at any time of the day with or without food.
+- Homozygous Familial Hypercholesterolemia: The dosage of Atorvastatin in patients with homozygous FH is 10 to 80 mg daily.
+- Patients with renal insufficiency: Renal disease has no influence on the plasma concentrations or lipid effects of Atorvastatin; thus no adjustment of dose is required. Hemodialysis is not expected to significantly enhance the clearance of Atorvastatin since the drug is extensively bound to plasma proteins.
+- Patients with hepatic dysfunction: In patients with moderate to severe hepatic dysfunction, the therapeutic response to Atorvastatin is unaffected but exposure to the drug is greatly increased.
+
",,"Drug interaction with atorvastatin: The risk of myopathy during treatment with drugs of this class is increased with concurrent administration of cyclosporine, fibric acid derivatives, niacin (nicotinic acid), erythromycin, azole antifungals. When atorvastatin and antacid suspension containing magnesium and aluminum hydroxide were co administered, plasma concentrations of atorvastatin decreased approximately 35%. However, LDL-C reduction was not altered. Plasma concentrations of atorvastatin decreased approximately 25% when colestipol and atorvastatin were co administered. However, LDL-C reduction was greater when atorvastatin and colestipol were co-administered than when either drug was given alone. When multiple doses of atorvastatin and digoxin were co-administered, steady state plasma digoxin concentrations increased by approximately 20%. Patients taking digoxin should be monitored appropriately. In healthy individuals, plasma concentrations of atorvastatin increased approximately 40% with co- administration of atorvastatin and erythromycin. Co- administration of atorvastatin and an oral contraceptive increased AUC values for norethindrone and ethinylestradiol by approximately 30% and 20%. These increases should be considered when selecting an oral contraceptive for a woman taking atorvastatin.
Drug interaction with amlodipine: Amlodipine may potentiate the effect of other antihypertensive (e.g.Beta-blockers, ACE inhibitors, Alpha-1-blockers and Diuretics). In clinical interaction studies, Amlodipine did not affect the pharmacokinetics of Atorvastatin, Digoxin, Warfarin or Cyclosporine.
","Amlodipine: Amlodipine is contraindicated in patients with known hypersensitivity to Amlodipine. Atorvastatin: Contraindicated in hypersensitivity to any component of this medication. Active liver disease or unexplained persistent elevations of serum transaminases exceed three times the upper limit of normal.
","Amlodipine: General: Since the vasodilatation induced by Amlodipine is gradual in onset, acute hypotension has rarely been reported after oral administration of Amlodipine. Nonetheless, caution should be exercised when administering Amlodipine as with any other peripheral vasodilator particularly in patients with severe aortic stenosis. Use in Patients with Congestive Heart Failure: Although hemodynamic studies and a controlled trial in Class-II-III heart failure patients have shown that Amlodipine did not lead to clinical deterioration as measured by exercise tolerance, left ventricular ejection fraction, and clinical symptoms. In general, all calcium channel blockers should be used with caution in patients with heart failure. Beta-blocker Rhabdomyolysis with acute renal failure secondary to myoglobinuria has been reported with other drugs in this class.
Atorvastatin: Atorvastatin may cause an elevation in serum creatine phosphokinase levels. This should be considered in the differential diagnosis of chest pain in patients on therapy with Atorvastatin. Uncomplicated myalgia has been reported in Atorvastatin-treated patients. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Side effects: Atorvastatin is generally well tolerated. Adverse effects reported commonly include constipation, flatulence, dyspepsia, abdominal pain, headache, nausea, myalgia, diarrhea, asthenia and insomnia.
","Safety in pregnancy has not been established. Use of HMG-CoA reductase inhibitors during breastfeeding is not recommended.
","Warning: Increased Angina and/or Myocardial Infarction Rarely, patients, particularly those with severe obstructive coronary artery disease, have developed documented increased frequency, duration and/or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase. The mechanism of this effect has not been elucidated. Liver Dysfunction. HMG-CoA reductase inhibitors, like some other lipid-lowering therapies, have been associated with biochemical abnormalities of liver function. Precaution
Amlodipine: General: Since the vasodilatation induced by Amlodipine is gradual in onset, acute hypotension has rarely been reported after oral administration of Amlodipine. Nonetheless, caution should be exercised when administering Amlodipine as with any other peripheral vasodilator particularly in patients with severe aortic stenosis.
Use in Patients with Congestive Heart Failure: Although hemodynamic studies and a controlled trial in Class-II-III heart failure patients have shown that Amlodipine did not lead to clinical deterioration as measured by exercise tolerance, left ventricular ejection fraction, and clinical symptoms. In general, all calcium channel blockers should be used with caution in patients with heart failure.
Atorvastatin: Rhabdomyolysis with acute renal failure secondary to myoglobinuria has been reported with other drugs in this class. Atorvastatin may cause an elevation in serum creatine phosphokinase levels. This should be considered in the differential diagnosis of chest pain in patients on therapy with Atorvastatin. Uncomplicated myalgia has been reported in Atorvastatin-treated patients. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.
","Pediatrics: Safety and efficacy of Atorvastatin have not been established in children.
Geriatrics: Efficacy and safety in older patients using recommended doses is similar to that seen in the general population.
",,,,"Store in a cool and dry place. Protect from light and moisture. Keep all medicines out of the reach of children.
",11
+63,Amlodipine Besilate + Atenolol,amlodipine-besilate-atenolol-63,,Combined antihypertensive preparations,Refractory angina pectoris where nitrate therapy has failed,"This is indicated in-
+
+- Patients with essential hypertension
+- Patients with angina pectoris & hypertension as co-existing diseases
+- ln post Ml patients
+- ln patients with refractory angina pectoris where nitrate therapy has failed.
+
","Combined antihypertensive preparations
","This is a fixed-dose combination of Amlodipine and Atenolol. Amlodipine is a dihydropyridine calcium antagonist that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle; it has a greater effect on vascular smooth muscle than on cardiac muscle. Amlodipine is a peripheral vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. Amlodipine reduces tone, decreases coronary vasoreactivity and lowers cardiac demand by reducing afterload.
Atenolol is a cardioselective beta-blocker. The cardio-selectivity is dose-related. Atenolol causes a reduction in blood pressure by lowering cardiac output, decreasing the plasma renin activity and sympathetic outflow from CNS. Atenolol also causes a reduction in myocardial oxygen demand by virtue of its negative inotropic and negative chronotropic effects.
","The recommended dosage is Amlodipine and Atenolol 5/25 mg tablet once daily. If necessary, the dosage may be increased to 5/25 mg two tablets daily or as advised by the physicians. The dosage however should be individualized.
",,"Disopyramide: Atenolol reduces the clearance of disopyramide by 20%. Additive negative inotropic effects on the heart may be produced.
Ampicillin: at doses of 1 gm and above may reduce Atenolol levels.
Oral antidiabetics and insulin: Beta-blockers may decrease tissue sensitivity to insulin and inhibit insulin secretion e.g. in response to oral antidiabetics. Atenolol has less potential for these actions.
","Hypersensitivity to either component, sinus bradycardia, second and higher degrees of heart block, cardiogenic shock, hypotension, congestive heart failure, poor left ventricular function.
","The combination of Amlodipine and Atenolol is well tolerated. Overall side-effects include
fatigue, headache, edema, nausea, drowsiness, anxiety and depression.
","The combination should be used during pregnancy only if the expected benefit outweighs the potential fetal risk. The combination should not be used by nursing mothers. If its use is considered necessary, breast-feeding should be stopped.
","Bronchospasm: The combination should be used with caution in patients with airway obstruction.
Renal impairment: The combination can be used in patients with renal impairment. However, caution may be necessary if the creatinine clearance is less than 30 ml/min because of possible reduction in the excretion of unchanged Atenolol.
Hepatic impairment: Caution may be necessary in the use of the combination in patients with severe liver damage because of prolongation of the elimination half-life of Amlodipine.
Drug withdrawal: Since coronary heart disease may exist without being recognized, patients should be warned against stopping the drug suddenly. Any discontinuation should be gradual and under observation.
",,"Though not documented, hypotension and less frequently congestive cardiac failure may occur in cases of overdosage. Unabsorbed drugs may be removed by gastric lavage or administration of activated charcoal. Symptomatic treatment is suggested.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+62,Amlodipine Besilate,amlodipine-besilate-62,https://medex.com.bd/attachments/DFypizNWuSNKJGawwfVE9OMkAtCpQG/amlodipine-besilate-tablets-revised-january-2013-prescribing-information,Calcium-channel blockers,Stroke,"Essential hypertension: Amlodipine is efficacious as monotherapy in the treatment of hypertension. It may be used in combination with other antihypertensive agents.
Angina pectoris: Amlodipine is indicated for the treatment of chronic stable angina pectoris ... Read more
Essential hypertension: Amlodipine is efficacious as monotherapy in the treatment of hypertension. It may be used in combination with other antihypertensive agents.
Angina pectoris: Amlodipine is indicated for the treatment of chronic stable angina pectoris and is efficacious as monotherapy. It may be used in combination with other antianginal agents.
Vasospastic angina: Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. It may be used as monotherapy or in combination with other antianginal drugs.
","Calcium-channel blockers
","Amlodipine is a dihydropyridine calcium-channel blocker, with a long duration of action, used for the treatment of hypertension and angina pectoris. Amlodipine influences the myocardial cells, the cells within the specialized conducting system of the heart, and the cells of vascular smooth muscle. Administration of Amlodipine results primarily in vasodilation, with reduced peripheral resistance, blood pressure and afterload, increased coronary blood flow and a reflex increase in coronary heart rate. This in turn results in an increase in myocardial oxygen supply and cardiac output.
","Hypertension: Usual dose is 5 mg once daily. The maximum dose is 10 mg once daily. Elderly patients with hepatic insufficiency may be started on 2.5 mg once daily; this dose may also be used when adding Amlodipine to other antihypertensive therapy.
Angina (Chronic stable or Vasospastic): 5 to 10 mg, using the lower dose for elderly and in patients with hepatic insufficiency. Most patients require 10 mg.
Administrations: May be taken without regard to meals.
",,"Drug Interactions-
+
+- Potentially hazardous interactions: Little or no data are available in patients with markedly impaired cardiac left ventricular function; however, as with other calcium antagonist drugs, the combination of Amlodipine and p-blockers should be avoided in such patients.
+
+Other Significant Interactions-
+
+- Digoxin: Absence of any interaction between Amlodipine and Digoxin in healthy volunteers has been documented in a controlled clinical study.
+- Cimetidine: An unpublished clinical study indicated no interaction between, Amlodipine and Cimetidine in healthy volunteers.
+- Warfarin: An unpublished clinical study in healthy volunteers indicates that Amlodipine did not significantly alter the effect of Warfarin on prothrombin time.
+- Food: Food does not alter the rate or extent of absorption of Amlodipine.
+
","Hypersensitivity to dihydropyridine derivatives. Pregnant woman.
","The most common adverse effects of amlodipine are associated with vasodilatory action, such as dizziness, flushing, headache, hypotension and peripheral edema. Gastrointestinal disturbances, increased micturition frequency, lethargy, eye pain and mental depression may also occur. A paradoxical increase in ischaemic chest pain may occur at the start of the treatment and in a few patients excessive fall in blood pressure has led to cerebral or myocardial ischaemia or transient blindness. Rashes, fever and abnormalities in liver function due to hypersensitivity reaction of Amlodipine may occur.
","Pregnancy Category C. There are no adequate and well-controlled studies of Amlodipine in pregnant women. Amlodipine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Amlodipine is excreted in human milk. In the absence of this information, it is recommended that nursing be discontinued while Amlodipine is administered.
","Precaution should be taken in patients with hepatic impairment and during pregnancy and breast feeding.
","Children with hypertension from 6 years to 17 years of age: 2.5 mg once daily as a starting dose, up-titrated to 5 mg once daily if blood pressure goal is not achieved after 4 weeks. Doses in excess of 5 mg daily have not been studied in pediatric patients.
Children under 6 years old: The effect of amlodipine on blood pressure in patients less than 6 years of age is not known.
Elderly: Amlodipine used at similar doses in elderly or younger patients is equally well tolerated. Normal dosage regimens are recommended in the elderly, but increase of the dosage should take place with care.
Renal impairment: Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment, therefore the normal dosage is recommended. Amlodipine is not dialysable.
Hepatic impairment: Dosage recommendations have not been established in patients with mild to moderate hepatic impairment; therefore dose selection should be cautions and should start at the lower end of the dosing range. The pharmacokinetics of Amlodipine have not been studied in severe hepatic impairment. Amlodipine should be initiated at the lowest dose (2.5 mg once daily) and titrated slowly in patients with severe hepatic impairment.
","Symptoms: Available data suggest that large overdosage could result in excessive peripheral vasodilatation and possibly reflex tachycardia. Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome have been reported.
Management: Clinically significant hypotension due to amlodipine overdosage calls for active cardiovascular support including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
A vasoconstrictor may be helpful in restoring vascular tone and blood pressure, provided that there is no contraindication to its use. Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade. Gastric lavage may be worthwhile in some cases. In healthy volunteers the use of charcoal up to 2 hours after administration of amlodipine 10 mg has been shown to reduce the absorption rate of amlodipine. Since amlodipine is highly protein-bound, dialysis is not likely to be of benefit.
",,,"Keep all medicines out of reach of children. Store in a cool & dry place, protected from light.
",12
+61,Amlexanox,amlexanox-61,https://medex.com.bd/attachments/NtQkGbq71h0iaSHtAdza2BlhU20gZd/amlexanox-prescribing-information,,,"Amlexanox is indicated for the treatment of aphthous ulcers.
",,"The mechanism of action by which Amlexanox accelerates healing of aphthous ulcers is unknown. In vitro studies have demonstrated Amlexanox to be a potent inhibitor of the formation and release of inflammatory mediators (histamine and leukotrienes) from mast cells, neutrophils and mononuclear cells. Given orally to animals, Amlexanox has demonstrated anti-allergic and anti-inflammatory activities and has been shown to suppress both immediate and delayed-type hypersensitivity reactions. The relevance of these activities of Amlexanox to its effects on aphthous ulcers has not been established. After a single oral application of 100 mg of paste (5 mg Amlexanox), maximal serum levels are observed at 2.4 hours. Most of the systemic absorption of Amlexanox is via the gastrointestinal tract and the amount absorbed directly through the active ulcer is not a significant portion of the applied dose. The half-life for elimination was 3.5 +/- 1.1 hours in healthy individuals.
","
+- Apply the paste as soon as possible after noticing the symptoms of an aphthous ulcer. Continue to use the paste four times daily, preferably following oral hygiene after breakfast, lunch, dinner, and at bedtime.
+- Dry the ulcer(s) by gently patting it with a soft, clean cloth.
+- Wash hands before applying.
+- Moisten the tip of the index finger.
+- Squeeze a dab of paste approximately ¼ inch (0.5 cm) onto a fingertip.
+- Gently dab the paste onto the ulcer. Repeat the process if more than one ulcer are present.
+- Wash hands after application.
+- Wash eyes promptly if they should come in contact with the paste.
+- Use the paste until the ulcer heals. If significant healing or pain relief has not occurred in 10 days, consultation with the physician is required.
+
",,,"Amlexanox oral paste is contraindicated in patients with known hypersensitivity to Amlexanox or other ingredients in the formulation.
","Adverse reactions reported by 1-2% of patients were transient pain, stinging and/or burning at the site of application. Infrequent (<1%) adverse reactions in the clinical studies were contact mucositis, nausea, and diarrhea.
","US FDA pregnancy category B. Teratology studies were performed with animals at doses up to two hundred and six hundred times, respectively, the projected human daily dose. No adverse fetal effects were observed. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Amlexanox was found in the milk of lactating rats; therefore, caution should be exercised when administering Amlexanox oral paste to a nursing woman.
","Wash hands immediately after applying Amlexanox oral paste directly to ulcers with the finger tips. In the event that a rash or contact mucositis occurs, discontinue use.
","Pediatric Use: Safety and effectiveness of Amlexanox oral paste in pediatric patients have not been established.
","Ingestion of a full tube of 5 grams of paste would result in systemic exposure well below the maximum nontoxic dose of Amlexanox in animals. Gastrointestinal upset such as diarrhea and vomiting could result from an overdose.
",,,"Store in a cool & dry place. Protect from light. Keep out of reach of the children
",10
+622,Amitriptyline Hydrochloride + Chlordiazepoxide,amitriptyline-hydrochloride-chlordiazepoxide-622,https://medex.com.bd/attachments/Ews4IA0aCY8UKcQJBDGAFIOJMsxezV/amitriptyline-hydrochloride-chlordiazepoxide-prescribing-information,Combined anxiolytics & anti-depressant drugs,Tension,"This is indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. Symptoms likely to respond in the first week of treatment include insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia.
","Combined anxiolytics & anti-depressant drugs
","Amitriptyline is a tricyclic antidepressant and Chlordiazepoxide is an anxiolytic. Amitriptyline inhibits the reuptake of norepinephrine and serotonin in the brain. This interference with the reuptake is responsible for the antidepressant activity of Amitriptyline. Chlordiazepoxide works by enhancing GABA-mediated chloride influx through GABA receptor channels, causing membrane hyperpolarization. The net neuro-inhibitory effects result in the observed sedative and anxiolytic effect.
","Optimum dosage varies with the severity of the symptoms and the response of the individual patient. When a satisfactory response is obtained, the dosage should be reduced to the smallest amount needed to maintain the remission. The larger portion of the total daily dose may be taken at bedtime. In some patients, a single dose at bedtime may be sufficient. This tablet in an initial dosage of 3 or 4 tablets daily in divided doses is satisfactory. Or directed by the physican.
",,"Because of its Amitriptyline component, this preparation may block the antihypertensive action of guanethidine or compounds with a similar mechanism of action.
","This is contraindicated in patients with hypersensitivity to either benzodiazepines or tricyclic antidepressants. It should not be given concomitantly with a monoamine oxidase inhibitor.
","Side effects: Many symptoms common to the depressive state, such as anorexia, fatigue, weakness, restlessness and lethargy, have been reported as side effects of treatment with this preparation.
Adverse reactions: Most frequently reported were drowsiness, dry mouth, constipation, blurred vision, dizziness and bloating. Less commonly included vivid dreams, impotence, tremor, confusion and nasal congestion.
","Safe use of this preparation during pregnancy and lactation has not been established.
","Use with caution in patients with a history of seizures. Close supervision is required when this preparation is given to hyperthyroid patients or those on thyroid medication. The usual precautions should be observed when treating patients with impaired renal or hepatic function. All pediatric patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality and unusual changes in behavior.
","Pediatric Use: Safety and effectiveness in the pediatric population have not been established. Anyone considering the use of Chlordiazepoxide and Amitriptyline Hydrochloride Tablets in a child or adolescent must balance the potential risks with the clinical need.
Geriatric Use: In elderly and debilitated patients it is recommended that dosage be limited to the smallest effective amount to preclude the development of ataxia, over sedation, confusion or anticholinergic effects.
","Deaths may occur from overdosage with this class of drugs. Critical manifestations of Amitriptyline overdose include cardiac dysrhythmias, severe hypotension, convulsions and CNS depression, including coma. Manifestations of benzodiazepine overdosage include somnolence, confusion, coma and diminished reflexes.
Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuance of Chlordiazepoxide. Generally, milder withdrawal symptoms (eg, dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Withdrawal symptoms (e.g., nausea, headache and malaise) have also been reported in association with abrupt Amitriptyline discontinuation.
",,,"Store in a cool and dry place, protected from light. Keep all medicines out of reach of the children.
",12
+60,Amitriptyline Hydrochloride,amitriptyline-hydrochloride-60,https://medex.com.bd/attachments/IcBaUM1VX9veFsvaJrXBpwFG8PlQMw/amitriptyline-hydrochloride-prescribing-information,Tricyclic Anti-depressant,Trichotillomania,"Amitriptyline Hydrochloride is indicated in-
+
+- Depressive Illness: particularly where sedation is required.
+- Nocturnal Enuresis in children.
+- Prophylaxis of Migraine.
+- Tension Headache.
+- Chronic Pain.
+
","Tricyclic Anti-depressant
","The mechanism of action of this drug is not fully elucidated. It is suggested that amitriptyline inhibits the membrane pump mechanism responsible for the re-uptake of transmitter amines, such as norepinephrine and serotonin, thereby increasing their concentration at the synaptic clefts of the brain. These amines are important in regulating mood. The monoamine hypothesis in depression, one of the oldest hypotheses, postulates that deficiencies of serotonin (5-HT) and/or norepinephrine (NE) neurotransmission in the brain lead to depressive effects. This drug counteracts these mechanisms, and this may be the mechanism of amitriptyline in improving depressive symptoms. Whether its analgesic effects are related to its mood-altering activities or attributable to a different, less obvious pharmacological action (or a combination of both) is unknown.
","Depression: Initially 75 mg (Elderly and Adolescents 30-75 mg) daily in divided doses or as a single dose at bedtime increased gradually as necessary to 150-200 mg; Child under 16 years not recommended for depression.
Nocturnal Enuresis: Child 7-10 years: 10-20 mg, 11-16 years: 25-50 mg at night; max. period of treatment (including gradual withdrawal) 3 months-full physical examination before the further course.
Prophylaxis of Migraine: 100 mg daily.
Tension Headache: 10-25 mg three times daily.
",,"TCA enhances the sedative effect of alcohol and opioid analgesics. When TCA is used with Moxifloxacin or Terfenadine, it increases the risk of ventricular arrhythmias. Disulfirum and Cimetidine inhibit the metabolism of Amitriptyline. When TCA is used with diuretics, it enhances the risk of postural hypotension.
","Amitriptyline is contraindicated in myocardial infarction, arrythmias, particularly heart block of any degree, mania and severe liver disease. Initially, sedation may affect the ability to drive or operate machinery.
","
+- Anticholinergic: Excessive perspiration, dry mouth, blurred vision, hyperpyrexia, urinary retention and urinary tract dilatation.
+- Cardiovascular reactions: Hypotension, syncope, postural hypotension, hypertension, tachycardia, palpitations, myocardial infarction, etc.
+- CNS and Neuromuscular: Confusional states, disturbed concentration, disorientation, delusions, etc.
+- Allergic: Skin rash, urticaria, photosensitization, etc.
+- Haematological: Bone-marrow depression.
+- Gastrointestinal: Nausea, epigastric distress, vomiting, anorexia, stomatitis, unpleasant taste, weight loss, diarrhoea, constipation, etc.
+- Endocrine: Testicular swelling, gynaecomastia, breast enlargement, galactorrhoea, etc.
+
","Pregnancy Category C. Amitriptyline has been shown to cross the placenta. Amitriptyline should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Amitriptyline is excreted into breast milk. Because of the potential for serious adverse reactions in nursing infants from Amitriptyline, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","It should be used with caution in patients with a history of epilepsy, glaucoma, urinary retention, cardiac disease, diabetes, pregnancy, hepatic impairment, thyroid disease, increased intra-ocular pressure and psychoses (may aggravate mania).
",,,,,"Store in a cool and dry place, below 30°C. Protect from light and moisture.
",10
+1649,Amisulpride,amisulpride-1649,https://medex.com.bd/attachments/FM0JEqYupkkQX6g7Fp3K2wANRSDbQN/amisulpride-tablet-prescribing-information,Atypical neuroleptic drugs,Post-operative nausea and vomiting,"Amisulpride tablet is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including ... Read more
Amisulpride tablet is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterized by predominant negative symptoms.
Amisulpride injection is indicated in adults for:
+
+- Prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class.
+- Treatment of postoperative nausea and vomiting (PONV) in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.
+
","Atypical neuroleptic drugs
","Amisulpride binds selectively to the human dopaminergic D2 and D3 receptor subtypes without any affinity for D1, D4 and D5 receptor subtypes. Unlike classical and atypical neuroleptics, amisulpride displays low affinity for serotonin, α- adrenergic, histamine receptor subtypes, muscarinic receptors and sigma sites. In the rodent, it preferentially blocks post synaptic D2 receptors located in the limbic structures as compared to those in the striatum as indicated by its reversal of d-amphetamineinduced hyperactivity without affecting stereotypies. In addition, it does not induce catalepsy and it does not produce D2 hypersensitivity after repeated treatment.
Moreover, it preferentially blocks pre-synaptic D2/D3 dopamine receptors, producing dopamine release responsible for its disinhibitory effects. This atypical pharmacological profile may explain amisulpride’s antipsychotic effect at higher doses through post-synaptic dopamine receptor blockade located in the limbic areas and its efficacy against negative symptoms, at lower doses, through presynaptic dopamine receptor blockade. In addition, the reduced tendency of amisulpride to produce extrapyramidal side effects may be related to its preferential limbic activity.
","Oral dose: For acute psychotic episodes, oral doses between 400 mg/d and 800 mg/d are recommended. In individual cases, the daily dose may be increased up to 1200 mg/d. Doses above 1200 mg/d have not been extensively evaluated for safety and therefore should not be used. Doses above 800 mg/d have not been shown to be superior to lower doses and may increase the incidence of adverse events. No specific titration is required when initiating the treatment with amisulpride.
Doses should be adjusted according to individual responses. Doses should preferably be administered before meals. Amisulpride should be administered twice daily for doses above 400 mg. For patients with mixed positive and negative symptoms, doses should be adjusted to obtain optimal control of positive symptoms. Maintenance treatment should be established individually with the minimally effective dose. For patients characterized by predominant negative symptoms, oral doses between 50 mg/d and 300 mg/d are recommended. Doses should be adjusted individually.
Injectable dose: The recommended injectable adult dosage of Amisulpride and infusion rate by indication is shown in the table below:
+
+- Prevention of postoperative nausea and vomiting: 5 mg as a single intravenous injection infused over 1 to 2 minutes at the time of induction of anesthesia.
+- Treatment of postoperative nausea and vomiting: 10 mg as a single intravenous injection infused over 1 to 2 minutes in the event of nausea and/or vomiting after a surgical procedure.
+
",,,"Hypersensitivity to the active ingredient or to other ingredients of the product. Concomitant prolactin-dependent tumours e.g. pituitary gland prolactinomas and breast cancer. Phaeochromocytoma. Children up to puberty. Lactation.
",,"pregnancy Category C. The safety of amisulpride during human pregnancy has not been established, and therefore use of amisulpride is not recommended during pregnancy and in women of child bearing potential not using effective contraception, unless the benefits justify the potential risks and the administered dose and duration of treatment should be as low and as short as possible. Amisulpride has been found in the breast milk of treated women. Breast-feeding is contraindicated.
","Neuroleptic Malignant Syndrome (NMS) is a potentially fatal syndrome that has been reported in association with anti psychotic medicines, including amisulpride. Neuroleptic malignant syndrome is characterised by hyperthermia, muscle rigidity, autonomic instability, and elevated CPK, may occur. In the event of any symptoms which could suggest NMS, in particular hyperthermia, particularly with high daily doses, all antipsychotic medicines including amisulpride should be discontinued. Amisulpride can lower the seizure threshold. Therefore patients with a history of seizures should be closely monitored during amisulpride therapy.
","Elderly: Amisulpride should be used with particular caution because of a possible risk of hypotension or sedation.
Children: The efficacy and safety of amisulpride from puberty to the age of 18 years have not been established: there are limited data available on the use of amisulpride in adolescents in schizophrenia. Therefore, the use of amisulpride from puberty to the age of 18 years is not recommended. In children up to puberty, the use of amisulpride is contraindicated
Use in hepatic impairment: The impact of hepatic impairment on hepatic metabolism and hepato-biliary excretion of amisulpride has not been studied. Amisulpride should be used with caution in patients with moderate or severe hepatic impairment.
Use in renal impairment: Amisulpride is eliminated by the renal route. In cases of renal insufficiency, the dose should be decreased and intermittent treatment should be considered
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+59,Amiodarone Hydrochloride,amiodarone-hydrochloride-59,https://medex.com.bd/attachments/lZCc1XvesJ3b0J3YfvTbqdFsRNXPwg/amiodarone-hydrochloride-tablet-prescribing-information,Potassium channel blockers,Ventricular arrhythmias,"Amiodarone tablet is used for many serious arrhythmias of the heart including ventricular fibrillation, ventricular tachycardia, atrial fibrillation, and atrial flutter.
Amiodarone injection is an antiarrhythmic agent indicated for initiation of treatment ... Read more
Amiodarone tablet is used for many serious arrhythmias of the heart including ventricular fibrillation, ventricular tachycardia, atrial fibrillation, and atrial flutter.
Amiodarone injection is an antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy.
","Potassium channel blockers
","Amiodarone Hydrochloride is used to correct abnormal rhythms of the heart. Amiodarone is considered a ""broad spectrum"" antiarrhythmic medication. The most important electrical effects of the drug includes : a delay in the rate at which the heart’s electrical system ""recharges"" after the heart contracts (repolarisation); a prolongation in the electrical phase during which the heart’s muscle cells are electrically stimulated (action potential); a slowing of the speed of electrical conduction (how fast each individual impulse is conducted through the heart’s electrical system); a reduction in the rapidity of firing of the normal generator of electrical impulses in the heart (the heart’s pacemaker); and a slowing of conduction through various specialised electrical pathways (called accessory pathways). In addition to being an antiarrhythmic medication, Amiodarone also causes blood vessels to dilate. Because of this effect it also may be of benefit in patients with congestive heart failure. This effect can result in drop of blood pressure.
","Tablet: 200 mg 3 times daily for 1 week reduced to 200 mg twice daily or the minimum required to control arrhythmia. Amiodarone is usually given in several daily doses to minimize stomach upset which is seen more frequently with higher doses. For this same reason, it is also recommended that Amiodarone should be taken with meals.
Injection: The recommended starting dose is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen:
+
+- Initial Load: 150 mg per 100 mL (in D5W or Normal Saline) infused over 10 minutes
+- Followed by: 1 mg/min for 6 hours
+- Followed by: 0.5 mg/min thereafter
+
+In the event of breakthrough episodes of VF or hemodynamically unstable VT: Repeat the Initial Load described above as needed (infused over 10 minutes). Increase the rate of maintenance infusion to achieve effective arrhythmia suppression.
",,"Amiodarone may interact with b blockers such as Atenolol, Propranolol, Metoprolol, or certain calcium channel blockers, such as Verapamil or Diltiazem, resulting in an excessively slow heart rate. Amiodarone increases the blood levels of Digoxin when the two drugs are given together. Flecainide blood concentrations increase by more than 50% with Amiodarone. Procainamide and Quinidine concentrations increase by 30-50% during the first week of Amiodarone therapy. Amiodarone also can interact with tricyclic antidepressants (TCA). Amiodarone interacts with Warfarin and increases the risk of bleeding. Amiodarone inhibits the metabolism of Dextromethorphan.
","Amiodarone is contraindicated in patients with cardiogenic shock; severe sinus-node dysfunction, causing marked sinus bradycardia; second- or third degree atrioventricular block; and when episodes of bradycardia have caused syncope (except when used in conjunction with a pacemaker). Amiodarone is contraindicated in patients with a known hypersensitivity to the drug or to any of its components, including iodine.
","The most severe side effects of Amiodarone therapy are related to the lungs. These reactions can be fatal. Patients should report any symptoms of cough, fever, or painful breathing. Although quite rare, fatal liver toxicity may occur with Amiodarone therapy. Reversible corneal microdeposits (sometimes with night glare), rarely impaired vision due to optic neuritis; peripheral neuropathy and myopathy (usually reversible on withdrawal); bradycardia and conduction disturbances; phototoxicity and rarely persistent skin discolouration; hypothyroidism, hyperthyroidism; raised serum transaminases; jaundice, hepatitis and cirrhosis are reported. Other rare complaints are nausea, vomiting, metallic taste, tremor, sweating, vertigo, headache, sleeplessness, fatigue, alopecia, benign raised intracranial pressure, ataxia, rashes, vasculitis, renal involvement, thrombocytopenia, haemolytic or aplastic anaemia. In some cases, dose of Amiodarone may be reduced. In other cases, Amiodarone therapy may need to be stopped.
","In general, Amiodarone should not be administered during pregnancy because there have been reports of hypo or hyperthyroidism in infants from oral Amiodarone use during pregnancy. If Amiodarone use is considered essential, however, the patient should be warned of the risk to the foetus. The safe use of Amiodarone in lactating women has not been established.
",,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+58,Aminophylline,aminophylline-58,https://medex.com.bd/attachments/8wrwxhCrczGqw7e7SZP4eNU90mhDOr/aminophylline-oral-tablet-prescribing-information,Bronchodilator,Status asthmaticus,"It is indicated for the treatment and prophylaxis of bronchospasm associated with asthma, emphysema and chronic bronchitis. Also indicated in adults for the treatment of cardiac asthma and left ventricular or congestive cardiac failure.
","Bronchodilator, Methyl xanthine derivatives, Respiratory stimulants: analeptics, Theophylline & related drugs
","Aminophylline is a combination of theophylline and ethylenediamine. Ethylenediamine is inactive; it increases the solubility of theophylline in water. Theophylline relaxes bronchial smooth muscle. Suggested mechanisms are an increase in intracellular cAMP through inhibition of phosphodiesterase; adenosine receptor antagonism, prostaglandin antagonism and effects on intracellular calcium.
","Oral:
Chronic bronchospasm:
+
+- Adult: As hydrate: Initially, 225-450 mg bid, increased if necessary.
+- Child: >3 yr: As modified-release hydrate: 12 mg/kg daily increased to 24 mg/kg daily in 2 divided doses after 1 wk.
+
+
Intravenous:
Acute severe bronchospasm:
+
+- Adult: Loading dose: 5 mg/kg (ideal body weight) or 250-500 mg (25 mg/ml) by slow inj or infusion over 20-30 min. Maintenance infusion dose: 0.5 mg/kg/hr. Max rate: 25 mg/min.
+- Child: Loading dose: same as adult dose. Maintenance dose: 6 mth-9 yr: 1 mg/kg/hr and 10-16 yr: 0.8 mg/kg/hr.
+- Elderly: Dose reduction may be necessary.
+- Hepatic impairment: Dose reduction may be necessary.
+
","Tablets should be swallowed whole and not chewed because of the structure of the tablet.
",,"Aminophylline should not be administered to patients with hypersensitivity to xanthines or ehylenediamine. It should not be administered to patients with active peptic ulcer, since it may increase the volume and acidity of gastric secretions.
","The most common adverse effects are gastric irritation, nausea, vomiting, diarrhea, hematemesis, epigastric pain and tremor. These are usually early signs of toxicity; however, with high doses, ventricular arrhythmias or seizures may be the first signs to appear and reactivation of peptic ulcer, headache, irritability, restlessness, insomnia, twitching, convulsion and reflex hyperexcitability, palpitation, tachycardia, hypotension, circulatory failure, ventricular arrhythmias, and flushing, albuminuria, diuresis and hematuria. Also inappropriate ADH syndrome may occur.
","Use of aminophylline in pregnant women should be balanced against the risk of uncontrolled disease.
","Aminophylline should be given with caution to patients with peptic ulceration, hyperthyroidism, hypertension, cardiac arrhythmias or other cardiovascular disease, or epilepsy, as these conditions may be exacerbated. They should also be given withcaution to patients with heart failure, hepatic dysfunction, chronic alcoholism, acute febrile illness, and to neonates and the elderly, since in all of these circumstances theophylline clearance may be decreased, resulting in increases in serum-theophylline concentrations and serum half-life.
",,,,,,9
+1706,Kabid Nawshadri,kabid-nawshadri-1706,,Herbal and Nutraceuticals,Indigestion,"Kabid Nawshadri is indicated in-
+
+- Weakness of stomach and liver
+- Hepatitis
+- Indigestion
+
","Herbal and Nutraceuticals
","This is a judicious combination of Embelia (Embelia ribes), Chebulic myrobalan (Terminalia chebula), Ginger (Zingiber officinale), Black pepper (Piper nigrum) and other valuable natural ingredients. It is a well known hepatoprotective unani medicine. It strengthens the liver and helps to relieve jaundice, hepatitis & indigestion. This is also effective in anorexia, nausea and vomiting.
","1-2 tablet(s) 2-3 times daily after meal or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in therapeutic dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1767,Jouban Satadal,jouban-satadal-1767,,Herbal and Nutraceuticals,Testosterone replacement therapy,"
+- Increases the secretion of testosterone & production of the sperm
+- Enhances viscosity of semen
+- Increases retentive power
+- Strengthens nervous system
+- prevents premature ejaculation
+- Prolongs the duration of coitus and ensures post coitus freshness.
+
","Herbal and Nutraceuticals
","Withania somnifera-
+
+- Chemical constituents: Withasominine, withaferin, withanolides, withaniol, glycosides etc.
+- Actions: It is used in neuroarthieties, debility in old age and cerebral circulation. It is also aphrodisiac.
+
+Mucuna prurita-
+
+- Chemical constituents: Mucuadine, mucuadinine, prurienidine, small amount of nicotine, reddish viscous oil etc.
+- Actions: It is used as aphrodisiac, tonic and diuratic. It is also used in dysentry .
+
+Anacyclus pyrethrum-
+
+- Chemical constituents: Anacyclin, pellitorine, enetriyne alcohol, hydrocarolin, inulin, volatile oil, sesamin etc.
+- Actions: It is used in rheumatism, paralysis, epilepsy and sexual disorders.
+
+Myristica fragrans-
+
+- Chemical constituents: pinine, terpinene, myristicin, trimyristin, myristic acid, saponin etc.
+- Action: It is used as carminative, stimulating, digestive and aphrodisiac.
+
","1-2 Capsules before bed time.
",,,"There is no absolute contraindication.
","Not yet known.
",,,,,,,"Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.
",7
+1521,Jogaraj Guggulu,jogaraj-guggulu-1521,,Herbal and Nutraceuticals,Spondylitis,"Jogaraj Guggulu is indicated in Rheumatoid arthritis, Osteoarthritis, Neuralgias, Myalgias, Spondylitis, Backaches, Joint pain, Arthralgia, Joint stiffness
","Herbal and Nutraceuticals
","Commiphora mukul: Guggulu is an exudates obtained in the form of oleogum resin from the stem of Commiphora mukul. It has analgesic & anti-inflammatory properties due to the presence of guggulsterone E & Z. Guggulsterone shows anti-inflammatory effect by inhibiting the activation of nuclear factor-kappa-B (NF-kappa-B).
Plumbago zeylanicum: Plumbago zeylanicum possesses flavonoids, which are known to inhibit the prostaglandins synthesis. Flavonoids of Plumbago zeylanicum help to reduce pain perception by suppressing pain substances like prostaglandins & bradykinin.It also controls excessive collagenase production.Study reveals that analgesic effect is comparable to that of Indomethacin.
Nigela sativa: Nigella sativa contains thymoquinone,which inhibits the effect of nociceptive system or inflammatory mediators and reduces pain. The anti-nociceptive effect of Nigella sativa is comparable with that of Naproxen.
Vanda Roxburghii: Vanda Roxburghii reduces pain & inflammation.Heptacosane & octacosan of Vanda roxburghii shows anti-inflammatory activity.
Zingiber officinale: Gingerol from Zingiber officinale possesses anti-inflammmatory and analgesic properties. This formulation inhibits production of prostaglandins & leukotrienes that are responsible for pain & inflammation.
The sea salt used in the short term performance of these plants helps.This herb acts as a carrier
material
","One capsule 2-3 times a day after meals or as advised by the physician.
",,"Large amounts of guggulu might theoretically increase the side effects of estrogen; decrease the effectiveness of diltiazem. Taking guggulu along with some medications like atorvastatin, ketoconazole, itraconazole& fexofenadine that are broken down by the liver can decreases the effectiveness of medications. Guggulu might increase thyroid hormone in the body.Taking guggulu along with thyroid hormone pills might increase the effects & side effects of thyroid hormone.
","No severe side effects have been observed with Jogaraj guggulu during the clinical practice for the last twenty-five years; however, systematic Phase 1 study with this drug is carried out and general tolerability of Jogaraj guggulu is found good.Maximum tolerable dose is about 9 gm per day.In rare case very high dose than prescribed may lead to stomach irritation, diarrhea, stomatitis & urticaria.
","No severe side effects have been observed with Jogaraj guggulu during the clinical practice for the last twenty-five years; however, systematic Phase 1 study with this drug is carried out and general tolerability of Jogaraj guggulu is found good.Maximum tolerable dose is about 9 gm per day. In rare case very high dose than prescribed may lead to stomach irritation,diarrhea,stomatitis & urticaria.
","Jogaraj guggulu should not be used during pregnancy or lactation.
",,,,,,"Keep in a cool,dry place & away from direct sun light.Keep the medicine out of children's reach.
",9
+1755,Jirakaddarista,jirakaddarista-1755,,Herbal and Nutraceuticals,Mild diarrhea,"Jirakaddarista is indicated in digestive disturbances (e.g. indigestion, flatulence, abdominal colic) & diarrhea.
","Herbal and Nutraceuticals
","Jira (Cuminum cyminum): Cumin contains volatile oil (2-5%), Fatty oil (10-15%), fatty acid, petroselic acid & palmitic acid. Cumin and flavones are chief constituents. Fatty oil of Cumin has an antimicrobial effect. It shuts mycelium growth and toxin production. It is used for flatulence, vomiting and indigestion.
Zamani (Trachyspermum ammi): The principal constituents of the essential oil from the fruits of Trachyspermum ammi are the phenols, mainly thymol and some carvacrol, variable amounts of P-cynene, Y-terpenine, Alfa & Vita-pinene & dipentene. Zamani is used as a digestive aid and for relieving gas and bloating. It relieves colic in babies and for children it also improves digestion and appetite.
Shuth (Zingiber officinale): It increases bile secretion & enhances gastrointestinal motility. It has anti-vomiting, anti-flatulent and digestive activities.
Lavanga (Syzygium aromaticum): Lavanga (clove) contains large amount of volatile oil. Cloves are used as a carminative, to increase hydrochloric acid in the stomach and to improve peristalsis.
Daruchini (Cinnamomum zeylanicum): It contains essential oil. It has carminative, stimulant, anti-infective, antifungal and digestive properties. It can help to relieve nausea and strengthen the immune system. It is also used for loss of appetite, dyspeptic complaints such as mild spastic condition of the GIT, bloating, flatulence.
Tajpata (Cinnamomum Tamala): It is a mild astringent and flavoring agent. Its oil is a powerful germicide.
Alach (Elettarea cardamomum): It contains volatile oil, resin, fixed oil, starch and calcium oxalate. It is aromatic, stimulant, stomachic, carminative & diuretic.
Naghkeshar (Mesua ferrea): It contains mesuagin, mesuol and essential oil. Mesuol has antibiotic activity. It is astringent, stomachic and aromatic. It is useful in gastric troubles.
Jaiphal (Myristca fragrans): It contains volatile oil, protein, myristc acid, tannin, niacin, essential oil and vitamins. It is used as tonics and reduced gastric acidity significantly.
","Children: 1/2-1 teaspoonfuls (2.5-5 ml) 2-3 times daily
",,"Anticoagulant drugs like warfarin, aspirin.
","There is no evidence available on contraindication but it may happen in patients who are hypersensitive to any of its ingredients. Ginger is contraindicated in people suffering from gallstones as it promotes the production of bile. So Jirakaddarist should be taken carefully in obstructive jaundice due to cholelithiasis.
","There is no significant side effect.
","No adverse effect of Jirakaddarist has been reported.
",,,,,,"Store in a cool & dry place, protected from light. Keep all medicines out of the reach of children.
",9
+1711,Jinsin,jinsin-1711,,Herbal and Nutraceuticals,Immunodeficiency,"This is indicated in-
+
+- General debility
+- Nervous debility
+- Sexual debility
+- Fatigue
+- Loss of memory
+- Anaemia
+- Immunodeficiency
+- Early aging
+- Senility
+
","Herbal and Nutraceuticals
","This is a unique antiaging, adaptogenic & herbal tonic. Jinsant contains Ashwagandha which is famous for antioxidant and antiaging properties. Jinsant acts as an adaptogen and immunostimulant. This improves physical and mental strength, enhances sexual power and increases the production of essential enzymes and hormones. Jinsant provides extra energy, makes the body strong, active and energetic.
","2-4 teaspoonfuls twice daily or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in therapeutic dosage.
",,"Keep out of reach of the children. Shake the bottle before use.
",,,,,"Store at cool and dry place, protect from light.
",8
+1527,Jeerakaddarishta Carminative,jeerakaddarishta-carminative-1527,,Herbal and Nutraceuticals,Severe diarrhea,"This syrup is indicated in dyspepsia or indigestion, abdominal colic, nausea and anorexia. It is also effective in diarrhea, false labor pain due to gas, GI problem after delivery and provide nutritional supplement to the lactating mothers. It also helps to treat reactive arthritis due to diarrhea or dysentery
","Herbal and Nutraceuticals
","Cuminum cyminum: Cumin contains volatile oil chiefly fatty-oil (10-15%), fatty acid,petroselic acid and palmitic acid. Cuminin and flavones are chief constituents. Fatty oil of Cumin has an antimicrobial effect.It stunts mycelium growth and toxin production.Volatile oil relaxes the gut as a whole and reduces the intestinal gas,bloating and flatulence.It is indicated in dyspepsia and diarrhea.
Cinnamomum zeylanicum: It is cordial,stimulant and tonic.In flatulence and spasmodic affections of the alimentary canal,it is proved as efficient carminative and antispasmodic.
Elettaria cardamomum: Ela has carminative and stimulant properties. It is used either as adjuvant or corrective of cordial,tonic and purgative medicines.
Cinnamomum tamala: It is a mild astringent and flavoring agent. Its oil is a powerful germicide.
Mesua ferrea: Flower contains essential oil, two bitter substances with bitter principle mesuol 1%. Antibiotic activity of mesuol has been found. It has astringent, carminative and expectorant properties. It is also useful for burning anus,blood dysentery and bleeding piles.
Zingiber officinale: In ancient Ayurvedic texts it is regarded very high for its beneficial effects for respiratory and digestive properties. It is used for multiple purposes like; constipation, indigestion, dyspepsia, arthritis & stiffness of joints. Ginger helps to combat gas either preventing the formation of gas in the stomach and intestines or helping with the expulsion of gas that has already built up.
Myristica fragrans: Jatipal contains acetic acid, fragransin, eugenol and myristicine. In Gl system, it is indicated in Diarrhea. It acts as tonic, digestive and also effective in Entamoeba histolytica and Ecoli.
Cyperus rotundus: In modern ayurvedic medicine it is used for treating fever, digestive system disorder, dysmenorrhea and other maladies. Several pharmacologically active substances have been identified in Cyperus rotundus e.g a-cyperone, (3-selinene, cyperene, cyperotundone, sugeonol, kobusone, and isokobusone which are scientifically proved for treating nausea, fever and inflammation.
Trachyspermum ammi: A preliminary pharmacological study of the oil indicates that it has a parasympathomimetic effect and produced contraction of the isolated ileum. It increases the secretion of pancreatic and intestinal enzymes like lipase, trypsin and amylase which helps to digest carbohydrate, protein and fat. It also increases the secretion of bile from the hepatocyte which plays an important role in fat digestion and absorption.
Syzygium aromaticum: Cloves are used in Ayurveda called ""Lavang"". In India, Chinese medicine, western herbal medicine and dentistry essential oil of this plant is used as an anodyne (painkiller).
Cloves are used as a carminative to increase hydrochloric acid in the stomach and to improve peristalsis.
","Children under 12 years: 1-2 teaspoonfuls (5-10 ml) two to three times daily.
Adult: 2-3 teaspoonfuls (10-15 ml) three times daily.
",,"Anticoagulant drugs like warfarin, aspirin
","There is no evidence available on contraindication but it may happen in patients who are hypersensitive to any of its ingredients. Ginger is contraindicated in people suffering from gallstones as it promotes the production of bile. So Jeerakaddarishta Carminative should be taken carefully in obstructive jaundice due to Cholelithiasis.
","There is no known significant side effect
","No adverse effect of Jeerakaddarishta Carminative syrup has been reported.
",,,,,,"Store at cool and dry place away from direct sunlight. Keep the medicine out of the reach of children
",9
+1749,Jamani Arka,jamani-arka-1749,,Herbal and Nutraceuticals,Indigestion,"This is indicated in Indigestion, Dyspepsia, Flatulence, Colic, Constipation.
","Herbal and Nutraceuticals
","This is an Ayurvedic liquid digestive medicine which is formulated from Jamani seed (Trachyspermum ammi) in a scientific manner. It provides quick relief from several digestive problems like indigestion, dyspepsia, flatulence, abdominal pain constipation.
Trachyspermum ammi- It contains essential oil (2-3.5%), phenol, thymol (35-60%), carvacrol, y terpinene, α and β pinenes, dipentene. It is antispasmodic, antimicrobial, antiseptic, stomachic, carminative and tonic. It is used in indigestion, dyspepsia, flatulence, colic, and constipation.
","Adult: 2-4 tea-spoonful to be taken with an equal quantity of water 2-3 times daily after meal.
Children: 1-2 tea-spoonful to be taken with an equal quantity of water 2-3 times daily after meal.
",,,"There is no major contraindication.
","Not yet known.
",,,,,,,"Store in a cool & dry place, protected from light. Keep all medicines out of the reach of children.
",7
+1720,"Jadwar [Denudatum, Saffron, Henbane]",jadwar-denudatum-saffron-henbane-1720,,Herbal and Nutraceuticals,Premature ejaculation,"This is indicated in-
+
+- Nervous debility
+- Depression
+- Premature ejaculation
+- General debility
+- Chronic Cold
+- Catarrh & cough
+
","Herbal and Nutraceuticals
","This is a unique combination of Denudatum (Delphinium denudatum), Saffron (Crocus sativus), Clove (Eugenia caryophyllus), Castorium and other natural ingredients. It is highly effective in nervous debility and acts as an ideal aphrodisiac. This is also useful in the treatment of general debility, chronic cold & cough.
","1-2 tablet(s) twice daily before meal or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1646,Ispaghula Husk + Sonapata,ispaghula-husk-sonapata-1646,,Bulk-forming laxatives,Ulcerative colitis,"This is indicated in Constipation, Intestinal inflammation, IBS Ulcerative colitis & Piles.
","Bulk-forming laxatives, Herbal and Nutraceuticals
","This is the formulation of Isabgul Spicy which is very effective herbal formulation of two mostly laxative medicinal herbs Plantago ovata & Cassia angustifolia. Ispaghula is capable of absorbing up to 40 times of water and Sonapata act as a inhibitor of water & electrolyte absorption from the large intestine that increase the volume and pressure of the intestinal contents. As a result it stimulates the peristaltic movement of the gut. In this way Isabgul Plus helps regular bowel movement and relieves constipation. Ispaghula has the ability to bind with bile acid; an important component of fat digestion found in our body from cholesterol. This process lowers circulating blood cholesterol level by excretion of those fats. Regular intake of Isabgul plus also helps to regularizes the function of GIT, cures constipation, intestinal irritation, intestinal inflammation, IBS & ulcerative colitis bulk forming of stool & ease evacuation, reduce hyperacidity, increase digestion & improves the function of digestive system as well as helps to normalize the gut health.
","Adult: 1 sachet or 4 gm powder with 150-200 ml water 1-2 times daily.
Children:
+
+- 6-12 years: 1/2 to 1 sachet or 2-4 gm powder with 150-200 ml water 1-2 times daily.
+- Under 6 years: As directed by the physician. 1/2 sachet or 2 gm powder with 150-200 ml water 1-2 times daily.
+
",,,"When dried husk intake orally without water may cause problems.
","In few cases it may occurs flatulence, stomach irritation & intestinal obstruction.
","This should not be used during pregnancy. It does not pass into breast milk. Therefore, it can be used safely lactation
","Plenty of water should take during this preparation intake. Should not use in the presence of intestinal obstruction acute inflammatory intestinal diseases or appendicitis.
",,,,,"Store in a cool & dry place, protect from light. Keep out of the reach of the children.
",9
+1310,Ispaghula Husk + Mebeverine Hydrochloride,ispaghula-husk-mebeverine-hydrochloride-1310,https://medex.com.bd/attachments/PdYK1sCaWHU6x3zbrHtq1kgYzwBRTo/ispaghula-husk-mebeverine-hydrochloride-prescribing-information,Bulk-forming laxatives,Hypercholesterolaemia,"Ispaghula Husk and Mebeverine Hydrochloride is indicated for the treatment of all kinds of IBS such as IBS-C, IBS-D & IBS-A.
","Bulk-forming laxatives, Herbal and Nutraceuticals
","This is a combination of Ispaghula Husk and Mebeverine Hydrochloride which is specially designed for IBS. Painful spasms of the gut and irregular bowel habits are the main symptoms of IBS. This product successfully relives these symptoms. Ispaghula Husk contains up to 70% of soluble and 30% of insoluble fibers. This unique feature makes it capable of absorbing up to 40 times of water of its own weight. Ispaghula Husk increases fiber in the diet, helps digestive system work more efficiently and gently relieve bowel problem in a natural way helping to restore and maintain regularity. Mebeverine is an antispasmodic drug that relieves spasms and cramps which occur in the gut causing pain without affecting normal gut motility.
","Ispaghula Husk and Mebeverine Hydrochloride is intended for oral use as a suspension in a drink of water. The granules of the sachet should be stirred into a glass of water and taken as soon as the effervescence subsides.
Adults and children over 12 years: One sachet in the morning and one in the evening with 1 glass of water. This medicine should be taken before half an hour of meal. A midday dose may be taken if necessary.
",,"Ispaghula Husk may delay gastric emptying time and reduce the absorption of Calcium, Iron and Zinc. Therefore, other agents should be taken one hour before or a few hours after taking Ispaghula Husk and Mebeverine.
","The drug is contraindicated if patients are allergic to it, in cases of intestinal obstruction, fecal impaction and if the patient has phenylketonuria.
","Ispaghula Husk and Mebeverine Hydrochloride are generally safe. But, some people may experience mild abdominal distension or flatulence for the first few days after starting this medicine. These effects should lessen as you continue the treatment.
","Ispaghula Husk is not absorbed into the bloodstream and does not pass into breast milk but Mebeverine Hydrochloride is absorbed into the bloodstream and passes through the breast milk. Therefore, this medicine should not be used during pregnancy unless considered essential by the physician.
","Do not take this medicine without water. It is important that each dose of granules is stirred into a glass of water before taking.
",,"Symptoms of Ispaghula Husk and Mebeverine overdose may include abdominal discomfort and flatulence. In case of overdose, patient should drink plenty of water.
",,,"This should be stored at room temperature. Protect from moisture and light. Keep it away from children.
",11
+1531,Hingastak Churna,hingastak-churna-1531,,Herbal and Nutraceuticals,Peptic ulcer disease,"Hingastak Churna is indicated in hyperacidity, peptic ulcer disease, NSAIDs induced gastric ulcer, gastritis and dyspepsia. It is also useful in gastroenteritis as an adjuvant therapy with antibiotics.
","Herbal and Nutraceuticals
","Hingastak churna is a polyherbal ayurvedic medicine used as a digestive, carminative, astringent and as an antacid. The ingredients present in Hingastak churna have been shown in different studies to possess biological properties related to antioxidant mechanism. Ferula assafoetida is known potent anti-oxidant, which protects free radical mediated gastric ulceration and carcinogenesis. The active constituent’s asaresinotannols 'A' & 'B' and ferulic acid of Ferula assafoetida help to reduce hyperacidity and abdominal pain. Phenolic amides of Piper nigrum has a stimulating effect on digestive organs and increase the low of saliva and gastric juices. Active component Zerumbon and gingerol of Zingiber offcinale reduce pain & inflammation of esophagus. Trachyspermum ammi is very effective in treating the excessive secretion of gastric gases. Moreover, Hingastak churna others gastro protection by increasing prostaglandin synthesis, mucin secretion and protects the stomach from injury.
","One Hingastak Churna capsule 2 times a day just before meals or as directed by the physician.
",,"Not Known.
","Hingastak churna is contraindicated in cases of known allergy to plants. Though it is well tolerated, precaution should be taken in moderate to severe hypertension & edema as it contains salt in 12.3% concentration.
","When used within the recommended dosage range, Hingastak Churna is well tolerated. In rare case very high dose than prescribed may lead to stomach irritation, diarrhea, stomatitis & urticaria. However it is best to use this product under medical supervision.
","Hingastak churna should not be used during pregnancy or lactation
",,,,,,"Keep the medicine out of children’s reach. Keep in a cool, dry place & away from direct sun light.
",9
+1690,Herbal Multivitamin,herbal-multivitamin-1690,,Herbal and Nutraceuticals,Malnutrition,"This herbal multivitamin syrup is indicated in-
+
+- General debility
+- Mental weakness
+- Anaemia of pregnancy
+- Hypolactation
+- Malnutrition
+- Lack of appetite
+- Vitamin deficiencies
+- Strenuous exercise
+- Rundown and debilitated condition
... Read more
This herbal multivitamin syrup is indicated in-
+
+- General debility
+- Mental weakness
+- Anaemia of pregnancy
+- Hypolactation
+- Malnutrition
+- Lack of appetite
+- Vitamin deficiencies
+- Strenuous exercise
+- Rundown and debilitated condition
+- During convalescence
+- Loss of weight
+- Elemental deficiency
+- Excessive metabolism
+- Vitamin deficiency due to antibiotics
+- Stress and acute illness
+- Nervousness & undue tendency to fatigue
+
","Herbal and Nutraceuticals
","This herbal multivitamin syrup is a non-alcoholic vitaminised herbal tonic of proven bioavailability in mental performance, anemia of pregnancy, lactating mothers and liver protection. This syrup can be used as a tonic in all seasons by the whole family. It provides optimum quantities of essential minerals, trace elements & vitamins required by the body. This herbal multivitamin syrup provides sufficient zinc which plays a significant role on the intellectual functioning of children. This syrup also contains a balanced proportion of extracts of various vitalizing herbs successfully used for centuries to provide energy and stimulation of muscles & nerves.
","Adults: 6 teaspoonfuls; Children: 2 teaspoonfuls; twice daily or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper usage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1688,Herbal gastric preparation,herbal-gastric-preparation-1688,,Herbal and Nutraceuticals,Nausea,"Herbal gastric preparation is indicated in-
+
+- Hyperacidity
+- Flatulence
+- Abdominal pain due to gases
+- Constipation
+- Stomach and liver disorders
+- Nausea and Vomiting
+- Loss of Appetite
+
","Herbal and Nutraceuticals
","Herbal gastric preparation is a special formulation of time-tested natural ingredients that helps to control acidity, flatulence, and indigestion. This helps in toning up the mucosa of the stomach and brings about a well-tolerated balance between liver functions and gastric activities. This is a safe and effective remedy for everyday stomach discomfort for the entire family.
","Syrup-
+
+- Adults: 2 teaspoonfuls 2-3 times daily.
+- Children: 1 teaspoonful 2-3 times daily or as prescribed by the physician.
+
+Tablet-
+
+- Adults: 1-2 tablet(s) 2-3 times daily
+- Children: 1/2 -1 tablet 2-3 times daily or as prescribed by the physician
+- Hyperacidity: 2 tablets/2 teaspoonfuls syrup before meal
+- Flatulence: 2 tablets/2 teaspoonfuls syrup after meal
+- Abdominal pain: 2 tablets/2 teaspoonfuls syrup with luke warm water. Repeat the dose after one hour if pain persists
+- Acute indigestion: 2 tablets/2 teaspoonfuls syrup
+- Chronic indigestion: 1 tablet/1-2 teaspoonful(s) syrup before and after each meal
+- Loss of appetite: 1 tablet/1-2 teaspoonful(s) syrup after breakfast. 1 tablet/ 1-2 teaspoonful(s) syrup before each meal with water
+- Constipation: 2 tablets/2 teaspoonfuls syrup at bed time with luke warm water
+- Stomach & Liver dysfunction: 2 tablets/2 teaspoonfuls syrup immediately before meal twice daily
+- Nausea and Vomiting: 1 tablet/1-2 teaspoonful(s) syrup. Tablet should be sucked slowly.
+
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Avoid fried & spicy foods. Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1740,Herbal cough syrup [Vasakarista],herbal-cough-syrup-vasakarista-1740,,Herbal and Nutraceuticals,Cough,"This syrup relieves alergic and dry irritable cough. It liquifies phlegm. It is very effective in asthma, smoker’s cough and throat hoarseness.
","Herbal and Nutraceuticals
","This syrup is a justified combination of herbs that is used to treat cough and some other respiratory tract disorders. All of the herbs in this combination are clinically effective in case of cough and cold. It is effective, well tolerated, safe and non-sedating with expectorant and antihistaminic properties. This syrup is effective for both children and adults. It is free from side effects like drowsiness, constipation and dryness of mouth.
+
+- Adhatoda vasica (Vasak): Relieves cough, bronchial spasm and breathlessness. It has also mucolytic and expectorant action.
+- Piper longum (Pipul) : It is used in cough, coryza, asthma, hoarseness of voice, bronchitis etc.
+- Glycyrrhiza glabra (Jasthi madhu) : It is widely used in fever, cold, cough and catarrh. It has an expectorant and anti-inflammatory action.
+- Terminalia chebula (Haritaki): It is used in cough conditions, asthma and itching.
+- Ficas infectoria (Kur): It is used in curing cough and bronchial asthma.
+- Acorus calamus (Bacha): It is used to treat a cough. It has expectorant properties. Moreover, it is used to treat fever, headache, asthma, bronchitis and tonsillitis.
+- Zingiber officinale (Shunthi): Shown to have significant effects in common cold.
+- Piper nigrum (Marich) : It has bacteriostatic, fungistatic and anti-inflammatory properties.
+- Syzygium aromaticum (Labanga) : Useful in cough and other respiratory disorders. It improves the breath and is a remedy for sore throat, headaches and coryza.
+- Cinnamomum zeylanicum (Darchini): It has anti- bacterial and anti-fungal activity. It is useful in relieving cough due to its soothing action.
+- Cinnamomum tamala (Tejpata) : It is a tonic, digestive, carminative, uterine stimulant & appetizer agent.
+- Rhus succedanea (Kakra sringi): It is an expectorant and soothe the irritability of the respiratory tract. It is known to help in cough, asthma and anorexia.
+- Myrica nagi (Katphal) : It is useful in catarrhal fever, cough and in the affections of throat.
+- Tulsi extract: Tulsi extract has been added to this syrup. It gives relief from common cold, bronchitis and cough.
+
","Children under 12 years: 1-2 teaspoonful (5-10 ml) 3 times a day.
Adult: 3 teaspoonful (15 ml) 2-3 times a day. In acute cough warm water can be added for better result.
",,"No clinically significant drug interactions have been reported.
","There is no evidence available on contraindication but it may happen in-patients who are hypersensitive to any of its ingredients.
","Ayurvedic medicine is clinically proven as safe & well tolerated. In the recommended doses, side effects are rare.
","The safety of this syrup in pregnancy has not been established. Therefore, it should be used with caution during pregnancy, considering benefits to the mother greater than the risks to fetus.
",,,,,,"Keep all medicines out of reach of children. Store in a cool and dry place protected from light.
",9
+1769,Herbal cough syrup [Tulsi],herbal-cough-syrup-tulsi-1769,,Herbal and Nutraceuticals,Cough,"ইহা শুষ্ক কাশি, দীর্ঘস্থায়ী কাশি, অ্যালার্জি জনিত কাশি সহ খুসখুসে কাশিতে কার্যকরী।
ইহা জমাট বাঁধা কফ তরল করে বের করে দেয়।
ইহা স্বরভঙ্গ এবং গলাব্যথা চিকিৎসায় কার্যকরী।
ইহা শ্বাসনালীর প্রদাহ এবং হাঁপানী চিকিৎসায় উপকারী।
ইহা হাঁচি ও শ্বাসনালীর সংকোচনে উপশম করে।
ইহা ব্রংকাইটিস ও এজমায় উপকারী।
ইহা ড্রাই কফ, ক্রনিক কফ, এলার্জিক কফ, স্বরভঙ্গ ও কাশিজনিত গলা ব্যথা দূর করতে খুবই কার্যকর।
","Herbal and Nutraceuticals
",,"প্রাপ্ত বয়স্কঃ ৩ চা চামচ করে প্রত্যহ ৩ বার।
অপ্রাপ্ত বয়স্কঃ ১-২ চা চামুচ করে প্রত্যহ ৩ বার অথবা চিকিৎসকের পরামর্শ অনুযায়ী সেব্য।
",,,,"ইহার কোন পার্শ্বপ্রতিকৃয়া না থাকায় শিশু, প্রেগন্যান্সি, Cardiac Patient দের জন্য বিশেষ ভাবে উপযোগী।
","ইহা প্রেগন্যান্সিতে safe.
",,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",6
+81,Artemether + Lumefantrine,artemether-lumefantrine-81,https://medex.com.bd/attachments/xE8RarvjpD3juzmKpJVHAarK7z9z8s/artemether-lumefantrine-prescribing-information,Anti-malarial drugs,Falciparum malaria,"This preparation is indicated for: Treatment and stand by emergency treatment of adults, children and infants with acute, uncomplicated infection due to Plasmodium falciparum or mixed infections including P. falciparum. Because Artemether and Lumefantrine is effective against both drug sensitive and ... Read more
This preparation is indicated for: Treatment and stand by emergency treatment of adults, children and infants with acute, uncomplicated infection due to Plasmodium falciparum or mixed infections including P. falciparum. Because Artemether and Lumefantrine is effective against both drug sensitive and drug resistance P. falciparum. This preparation is also recommended for malaria infections acquired in areas where the parasites may be resistant to other antimalarials. Stand by emergency treatment: Most tourists and business travelers, considered to be non-immune, will be able to obtain prompt medical attention if malaria is suspected. However a minority at risk of infection may be unable to obtain such care within 24 hours of onset of symptoms, particularly if they are in an isolated location far from medical services. In such case, prescribers are advised to issue Artemether and Lumefantrine to be carried by the traveler for self-administration (stand by emergency treatment). Consideration should be given to official guidance regarding the appropriate use of the anti-malarial agents.
","Anti-malarial drugs
","This preparation contains a fixed ratio of 1:6 parts of Artemether and Lumefantrine respectively. Artemether is a derivative of naturally occurring substance Artemisinin. Lumefantrine is a synthetic racemic fluorine mixture belonging to the aryl amino alcohol family like other anti-malarials (e.g. Quinine, mafloquine, halofantrine). Both components act in the food vacuoles of malarial parasites, where they are thought to interfere with the conversion of haem, a toxic intermediate formed during haemoglobin breakdown, to the non-toxic haemozin (a malaria pigment). Lumefantrine is thought to interfere with the polymerization process, while Artemether generates reactive metabolites as a result of interaction between the peroxide bridge and haem iron. Both Artemether and Lumefantrine have a secondary action involving inhibition of nucleic acid - protein synthesis within the malarial parasites. This tablet did not induce resistance. This tablet is active against blood stages of Plasmodium vivax, but it is not active against hypnozoites. Therefore, sequential treatment with premaquine should be used to achieve hypnozoite eradication.
","Patients with acute malaria are frequently averse to food. The dose should be taken with high fat food or drinks such as milk. In the event of vomiting within 1 hour of administration a repeat dose should be taken.
Adults and children weighing 35 kg and above: A standard 3 days treatment schedule with a total of 6 doses is recommended dosage is 4 tablets as a single dose at the time of initial diagnosis, again 4 tablets after eight hours, and then 4 tablets twice daily (morning and evening) on each of the following two days (Total course comprises 24 tablets).
5 to <15 kg body weight: 1 tablet at the time of initial diagnosis, 1 tablet again after 8 hours and then 1 tablet twice daily (morning and evening) on each of the following two days (Total course comprises of 6 tablets).
15 to <25 kg body weight: 2 tablets as a single dose at the time of initial diagnosis , 2 tablets again after 8 hours and then 2 tablets twice daily (morning and evening) on each of the following two days (Total course comprises 12 tablets).
25 to <35 kg body weight: 3 tablets as a single dose at the time of initial diagnosis, 3 tablets again after 8 hours and then 3 tablets twice daily (morning and evening) on each of the following two days (Total courses comprises 18 tablets).
",,"No such result is available.
","Hypersensitivity to any of the ingredients or excipients; Patients with severe malaria according to WHO definition; First trimester of pregnancy; Patients with a family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as patients with a history of symptomatic cardiac arrythmias with clinically relevant bradycardia or with severe cardiac disease; Patients with known disturbance of electrolyte balance e.g. hypokalaemia or hypomagnesemia; Patients taking any drug which is metabolized by the cytochrome enzyme CYP2D6 (e.g. flecainide, metoprolol, imipramine, amitriptyline, clomipramine).
","It is generally very well tolerated by children and adults, with most adverse effects are of mild to moderate severity and duration. Hypersensitivity, headache, dizziness, sleep disorder, somnolence, involuntary muscle contractions, paraesthesia, hypoesthesia, abnormal gait, ataxia, palpitation, cough, abdominal pain, anorexia, diarrhoea, vomiting, nausea, pruritus, rash, arthralgia, myalgia, asthenia, fatigue.
","Use in pregnancy & lactation is contraindicated; especially in the first trimester of pregnancy. Breast feeding women should not take this preparation. Due to the long elimination half-life of Lumefantrine (4-6 days), it is recommended that breast feeding should not resume before day 28 unless potential benefits to the mother and child outweigh the risk of treatment.
","This has not been evaluated for prophylaxis and is therefore not indicated. This is also not evaluated for the treatment of cerebral malaria or other severe manifestations of severe malaria including pulmonary oedema or renal failure.
",,"In cases of suspected over dosage, symptomatic and supportive therapy should be given as appropriate. ECG and blood potassium level should be monitored.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+80,Artemether,artemether-80,,Anti-malarial drugs,Schistosomiasis,"Artemether is indicated for Malaria, Schistosomiasis.
","Anti-malarial drugs
","Artemether is a potent and rapidly acting blood schizontocide, which is highly efficacious in treating chloroquine-resistant falciparum malaria, and complicated falciparum malaria including cerebral malaria. Its quick onset of effect and high efficacy in bringing down the parasite load are the properties which make this drug a suitable therapeutic option against falciparum infection.
","Adult: 80 mg twice daily for 1 day followed by 80 mg once daily for 4 days. Maximum dose: 480 mg for 5 days.
Children: 3.2 mg/kg/day in 2 divided doses followed by 1.6 mg/kg/day once daily for 4 days. Maximum dose: 9.6 mg/kg for 5 days.
",,"Artemether causes QT prolongation in some patients. Thus concomitant use of erythromycin, terfenadine, procainamide, quinidine, disopyramide, amiodarone, bretylium, bepridil, sotalol, astemizole, probucol, tricyclic antidepressants, phenothiazines may be avoided.
","Contraindicated in patients with hpersensitivity to Artemether.
","Mild Gl disturbance, dizziness, tinnitus, reduction in reticulocyte and leucocyte counts, nausea, vomiting, abdominal pain, bradycardia, first degree heart block, transient increase in serum transaminases.
","Pregnancy Category-C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","Avoid concomitant use of drugs known to prolong QT interval or monitor such patients.
",,,,,,9
+1372,Armodafinil,armodafinil-1372,https://medex.com.bd/attachments/XJUk488If19s3u8sLb85pJySM89BNf/armodafinil-prescribing-information,CNS stimulant drugs,Shift work disorder (SWD),"Armodafinil is indicated to improve wakefulness in adult patients with-
+
+- Obstructive sleep apnea (OSA)
+- Narcolepsy
+- Shift work disorder (SWD)
+
","CNS stimulant drugs
","Armodafinil is an indirect dopamine receptor agonist. This is the R-enantiomer of Modafinil which is a 1:1 mixture of the R- and S-enantiomers. Armodafinil binds to the dopamine transporter and inhibits dopamine reuptake. As a result, increases neuronal activity in the hypothalamus, enhances activity in hypothalamic wakefulness center (TMN, tuberomammillary nucleus) within the hypothalamic sleep wake switch.
","Adults:
+
+- Obstructive Sleep Apnea (OSA) & Narcolepsy: 150 mg to 250 mg as a single dose in the morning.
+- Shift Work Disorder (SWD): 150 mg as a single dose approximately 1 hour prior to the start of work shift.
+
+
Children: Safety and effectiveness in pediatric patients less than 17 years of age have not been established.
Elderly: In elderly patients, elimination of Armodafinil and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses and close monitoring in this population.
",,"The clearance of drugs that are substrates for CYP3A4 or CYP3A5 (e.g., steroidal contraceptives, Cyclosporine, Midazolam and Triazolam) may be increased by Armodafinil which results in lower systemic exposure. Dosage adjustment of these drugs should be considered when used concomitantly with Armodafinil.
Elimination of drugs that are substrates for CYP2C19 (e.g., Phenytoin, Diazepam, Propranolol, Omeprazole and Clomipramine) may be prolonged by Armodafinil which results in higher systemic exposure. Dosage adjustment of these drugs should be considered when used concomitantly with Armodafinil.
More frequent monitoring of prothrombin times/ International normalized ratio (INR) should be considered whenever Armodafinil is co-administered with Warfarin.
Caution should be used when concomitantly administering MAO inhibitors and Armodafinil.
","Contraindicated in patients with known hypersensitivity to Armodafinil or any of theexcipients of this product
","The most common side effects of Armodafinil are serious rash, including Stevens-Johnson syndrome, angioedema and anaphylaxis reactions, multi-organ hypersensitivity reactions, persistent sleepiness, psychiatric symptoms and some cardiovascular events.
","Pregnancy: There are no adequate and well controlled studies of Armodafinil in pregnant women. Armodafinil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is not known whether Armodafinil or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Armodafinil is administered to a nursing woman.
","Patients should be cautioned about operating an automobile or other hazardous machinery until it is reasonably certain that Armodafinil therapy will not adversely affect their ability to engage in such activities. Caution should be taken in treating patients with a history of psychosis, depression or mania. Discontinuation of treatment should be considered if psychiatric symptoms develop. Increased monitoring of heart rate and blood pressure should be exercised. Caution should be exercised when prescribing Armodafinil to patients with known cardiovascular disease.
","Patients with hepatic impairment: In patients with severe hepatic impairment, Armodafinil should be administered at a reduced dose.
Patients with renal impairment:There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment.
","There were no overdoses reported in the Armodafinil clinical studies. Symptoms of Armodafinil overdose are likely to be similar to those of Modafinil which included excitation or agitation, insomnia and slight or moderate elevations in hemodynamic parameters. There is no specific antidote for Armodafinil overdose. However, if overdose occurs, it should be managed with primary supportive care.
",,,"Store in a cool (below 25°C) and dry place protected from light.
",12
+75,Aripiprazole,aripiprazole-75,https://medex.com.bd/attachments/MRXU3HsFHbKVnUOWtQoKFFPWVLOBL7/aripiprazole-revised-082016-prescribing-information,Atypical neuroleptic drugs,Schizophrenia,"Aripiprazole is indicated for-
+
+- Schizophrenia
+- Schizoaffective disorder
+- Acute manic and mixed episodes associated with Bipolar I Disorder
+- Maintaining efficacy in patients with Bipolar I Disorder who are stabilized
+
","Atypical neuroleptic drugs
","Aripiprazole is an atypical antipsychotic that has both dopamine and serotonin receptors activity. It is a partial agonist of dopamine D2 receptors that relieves the symptoms of schizophrenia. It is characterized as a dopamine system stabilizer. It is a potent partial agonist at serotonin 5-HT1A receptors and antagonist at 5-HT2A receptors. This is associated with improvement of depressive, cognitive and negative symptoms.
","For Schizophrenia: 10 to 15 mg, once daily, without regard to food. Dose increment should not be made before 2 weeks, the time needed to achieve steady state.
For Bipolar mania: 30 mg, once daily, without regard to food.
",,"Caution should be exercised when aripipazole is taken in combination with other centrally acting drugs and alcohol. Carbamazepine could cause an increase in aripiprazole clearance and lower blood levels. Ketoconazole, quinidine, fluoxetine or paroxetine can inhibit aripiprazole elimination and cause increased blood levels.
","Aripiprazole is contraindicated in patients who are hypersensitive to it or to any component of this product.
","Headache, constipation, asthenia, nausea, dyspepsia, vomiting, coughing, abdominal pain.
","Aripiprazole should not be used in pregnancy as no human trial is performed. Patients should be advised not to breast feed an infant if they are taking aripiprazole.
","Aripiprazole may be associated with orthostatic hypotension (orthostatic lightheadedness).
Aripiprazole should be used with caution in patients with known cardiovascular disease (myocardial infarction or ischaemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or conditions that would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medications).
Seizures occurred in aripiprazole-treated patients. As with other antipsychotic drugs, aripiprazole should be used cautiously in patients with Alzheimer's dementia.
Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.
",,"Aripiprazole at doses up to 1080 mg causes no fatalities. The signs and symptoms observed with aripiprazole overdose included nausea, vomiting, asthenia, diarrhea, and somnolence.
",,,,10
+1815,Arformoterol Tartrate,arformoterol-tartrate-1815,https://medex.com.bd/attachments/yh4zvi03Fr3B7YSS8nUaB0sXB6qPNL/arformoterol-tartrate-prescribing-information,Bronchodilator,Emphysema,"Arformoterol is indicated for long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Important limitations of use: Arformoterol ... Read more
Arformoterol is indicated for long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Important limitations of use: Arformoterol nebuliser solution is not indicated to treat acute deteriorations of COPD. People with asthma, who take long-acting beta2 adrenergic agonist (LABA) medicines, such as Arformoterol, have an increased risk of death from asthma problems
","Bronchodilator
",,"The recommended dose of Arformoterol nebuliser solution is one 15 mcg unit-dose ampoule administered twice daily (morning and evening) by nebulization. A total daily dose of greater than 30 mcg (15 mcg twice daily) is not recommended.
Pediatric Use: COPD does not occur in children. The safety and efficacy of Arformoterol nebuliser solution in pediatric patients have not been established
",,"Other adrenergic drugs may potentiate effect. Xanthine derivatives, steroids, diuretics, or non-potassium sparing diuretics may potentiate hypokalemia or ECG changes. MAO inhibitors, tricyclic antidepressants and drugs that prolong the QTc interval may potentiate effect on the cardiovascular system. Beta-blockers may decrease effectiveness.
",,"Most common adverse reactions are pain, chest pain, back pain, diarrhea, sinusitis, leg cramps, dyspnea, rash, flu syndrome, peripheral edema and lung disorder. Arformoterol can cause serious side effects, including: People with asthma, who take LABA medicines, have an increased risk of death from asthma problems. Patient should get emergency medical care if:
+
+- Breathing problems worsen quickly
+- After the use of rescue inhaler medicine, it does not relieve breathing problems.
+
","Pregnancy Category C. Arformoterol nebuliser solution should be used during pregnancy, only if the potential benefit justifies the potential risk to the fetus. It is not known whether arformoterol is excreted in human milk.
","Arformoterol nebuliser should not be initiated in acutely deteriorating patients. It should be used with caution in patients with cardiovascular or convulsive disorders, thyrotoxicosis, or with sensitivity to sympathomimetic drugs. Life-threatening paradoxical bronchospasm can occur.
",,"As with all inhaled sympathomimetic medications, cardiac arrest and even death may be associated with an overdose of Arformoterol nebuliser solution.
",,,"Arformoterol nebuliser solution should be stored at 2-8°C, protected from light and excessive heat. Do not freeze. Keep out of the reach of children.
",9
+1488,Arabinoxylan,arabinoxylan-1488,https://medex.com.bd/attachments/fInQrGHJek5roQwiPZZgkyxa2jiTyP/arabinoxylan-prescribing-information,Immunomodulator,Heart disease,"Arabinoxylan is able to increase NK cell activity by as much as 300% in just a couple of weeks, whilst T and B cell activity are increased by 200 and 150% respectively. Research has also shown that it can help significantly boost natural antibody production, as well as other parameters of the immune ... Read more
Arabinoxylan is able to increase NK cell activity by as much as 300% in just a couple of weeks, whilst T and B cell activity are increased by 200 and 150% respectively. Research has also shown that it can help significantly boost natural antibody production, as well as other parameters of the immune system. This is particularly important as we age as the immune system naturally declines with age.
Research shows that Arabinoxylan also has anti-inflammatory effects and antioxidant scavenging activity, as well as the ability to improve glucose tolerance, enhance pancreatic and liver function, reduce the adverse effects of chemotherapy, and improve general quality of life.
This ability to enhance the immune system and reduce inflammation means that Arabinoxylan is an important food supplement for a variety of situations. (Please note that the majority of research has been conducted in relation to cancer, and that more research needs to be done on viral infections, bacterial infections and diabetes.)
This product is basically used for the patients who are attacked by cancer, virus, bacteria.
","Immunomodulator
","Arabinoxylan might work by reducing the amount of sugar and cholesterol that is absorbed in the stomach and intestines.
","The recommended dose of Arabinoxylan is 1 to 3 gram per day, taken orally.
As the body does not build up a resistance to Arabinoxylan over time, this food supplement can safely and effectively be taken over an extended period of time, and without the necessity of slowly increasing the dosage as with other immunomodulators.
Most research into Arabinoxylan has been conducted using 30 to 45 mg/kg/day in a divided dose with meals, with maintenance doses down to 15 mg/kg/day. A dosage of at least 500 mg a day should be taken for general health maintenance (unless potentised with yeast); for more serious immune support (such as in the case of arthritis, diabetes, hepatitis B, hepatitis C and other infections) the recommended dosage should be 1000 mg a day; and for serious conditions where the immune system is severely compromised (such as with cancer or AIDS) 3 g per day is recommended for 1 month and then 1g per day thereafter.
Arabinoxylan should always be taken after food (ideally, 30 minutes after) and larger daily intakes should be divided into three portions and taken with breakfast, lunch and dinner. If the person taking the compound is very ill, they can stay on the 3 g per day intake for an extended period.
Apart from the case of general health maintenance, we always recommend that your doctor be informed that you are taking this supplement, so that he or she can integrate it into your treatment program. intake for an extended period.
",,"Medications for diabetes (Antidiabetes drugs)Interaction Rating: Moderate Be cautious with this combination. Arabinoxylan might decrease blood sugar. Diabetes medications are also used to lower blood sugar. Taking arabinoxylan along with diabetes medications might cause your blood sugar to go too low. Monitor your blood sugar closely. The dose of your diabetes medication might need to be changed.
",,"Arabinoxylan compound is a natural product that has no adverse or toxic side-effects, confirmed by blood tests and examinations of liver and kidney function of people who have taken high amounts of the compound over several months. The only obvious contraindication is that, as an immunomodulator, able to boost weak immune systems, it should not be taken in conjunction with any medication specifically for suppressing the immune system.
And, although mushroom enzymes are used in Arabinoxylan manufacture, there is no mushroom content in the final product, which means that nearly all those with mushroom intolerances have been able to take it without an allergic reaction. This compound has also been authorized by the Japan Health Food and Nutrition Food Association, and has passed strict evaluation standards set under the guidance of the Ministry of Health and Welfare.
","Not enough is known about the use of arabinoxylan during pregnancy and breast-feeding
",,,"Arabinoxylan has been clinically shown to be completely non-toxic, even in extremely high doses. It is also safe for children and infants (intake scaled down by body weight).
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+74,Aprepitant,aprepitant-74,https://medex.com.bd/attachments/I7VesUzilNOHvNT4ALnuy8ASKeTvvt/aprepitant-prescribing-information,Anti-emetic drugs,Nausea and vomiting,"Aprepitant is indicated for-
+
+- Prevention of postoperative nausea and vomiting (PONV)
+- Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)
+
","Anti-emetic drugs
","Aprepitant is a selective high affinity antagonist of human substance P neurokinin 1 (NK1) receptors. When substance P attaches to these receptors, it causes nausea and vomiting. Aprepitant stops substance P from binding to the NK1 receptors. By blocking the receptors, Aprepitant can prevent nausea and vomiting, which often happens after chemotherapy or as a complication of surgery.
","Post Operative Nausea and Vomiting: The recommended oral dosage of Aprepitant is 40 mg within 3 hours prior to induction of anesthesia.
Chemotherapy-Induced Nausea and Vomiting:
** The following regimen should be used for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy-
+
+- Day 1: Aprepitant 125 mg orally, Dexamethasone 12 mg orally, 5-HT3 antagonist (Ondansetron): 24 mg 30 minutes before the start of chemotherapy.
+- Day 2: Aprepitant 80 mg orally, Dexamethasone 8 mg orally
+- Day 3: Aprepitant 80 mg orally, Dexamethasone 8 mg orally
+- Day 4: Dexamethasone 8 mg orally
+
+Aprepitant is administered orally 1 hour prior to chemotherapy treatment on Day 1 and in the morning on Days 2 and 3. Dexamethasone is administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. The dose of dexamethasone accounts for drug interactions.
** The following regimen should be used for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy:
+
+- Day 1: Aprepitant 125 mg orally, Dexamethasone 12 mg orally, 5-HT3 antagonist (Ondansetron): one 8 mg tablet 30 minutes before chemotherapy followed by an 8 mg dose 8 hours later.
+- Day 2: Aprepitant 80 mg orally, 5-HT3 antagonist (Ondansetron): 8 mg tablet twice a day
+- Day 3: Aprepitant 80 mg orally, 5-HT3 antagonist (Ondansetron): 8 mg tablet twice a day.
+
+Aprepitant is administered orally 1 hour prior to chemotherapy treatment on Day 1 and in the morning on Days 2 and 3. Dexamethasone is administered 30 minutes prior to chemotherapy treatment on Day 1. The dose of dexamethasone accounts for drug interactions.
","Aprepitant may be taken with or without food. No dosage adjustment is necessary for the elderly patients.
","Aprepitant is a substrate, a weak-to-moderate (dose dependent) inhibitor, and an inducer of CYP3A4. Aprepitant is also an inducer of CYP2C9. Precautions should be taken while coadministering Aprepitant with drugs that use CYP3A4 or CYP2C9, for example- Warfarin, Tolbutamide, Phenytoin, Ketoconazole, Itraconazole, Nefazodone, Troleandomycin, Clarithromycin, Ritonavir, Nelfinavir, Diltiazem, Rifampin, Carbamazepine etc.
Upon coadministration with Aprepitant, the efficacy of hormonal contraceptives during and for 28 days following the last dose of Aprepitant may be reduced. Alternative or back-up methods of contraception should be used during treatment with Aprepitant and for 1 month following the last dose of Aprepitant.
","Aprepitant is contraindicated in patients who are hypersensitive to any component of the product. Aprepitant should not be used concurrently with Pimozide, Terfenadine, Astemizole & Cisapride.
","Constipation, Hypotension, Pruritus, Pyrexia
","Pregnancy Category B. This drug should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug based on patient’s importance.
",,"Patients with Renal Impairment: No dosage adjustment is necessary for patients with renal impairment or for patients with end-stage renal disease (ESRD) undergoing hemodialysis.
Patients with Hepatic Impairment: No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. There are no clinical data in patients with severe hepatic impairment.
","No specific information is available on the treatment of overdosage with Aprepitant. Single doses up to 600 mg of Aprepitant were generally well tolerated in healthy subjects. Drowsiness and headache can be seen due to overdose. In the event of overdose, Aprepitant should be discontinued. General supportive treatment and monitoring should be provided. Because of the antiemetic activity of Aprepitant, medicine-induced emesis may not be effective. Aprepitant cannot be removed by hemodialysis.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+1378,Apremilast,apremilast-1378,https://medex.com.bd/attachments/N92DnyBRnD6bsJ6lQLQd2UGPx1ljej/apremilast-prescribing-information,Disease-modifying antirheumatic drugs (DMARDs),Psoriatic arthritis,"Apremilast is indicated for the treatment of adult patients with active psoriatic arthritis and moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
","Disease-modifying antirheumatic drugs (DMARDs)
","Apremilast is a novel, orally available small molecule inhibitor of type-4 cyclic nucleotide phosphodiesterase (PDE-4). PDE-4 is a cyclic adenosine monophosphate (cAMP)-specific phosphodiesterase that is predominantly located in inflammatory cells. By inhibiting PDE-4, apremilast increases intracellular levels of cAMP and thereby inhibits the production of multiple proinflammatory mediators including PDE-4, TNF-alpha, interleukin-2 (IL-2), interferon-gamma, leukotrienes, and nitric oxide synthase. By targeting a central component of the inflammatory signaling cascade rather than a single inflammatory marker, PDE-4 inhibition may restore the homeostatic balance between pro- and anti-inflammatory signalling.
","The recommended initial dosage titration of Apremilast from Day 1 to Day 5 is shown below. Following the 5-day titration, the recommended maintenance dosage is 30 mg twice daily taken orally starting on Day 6. This titration is intended to reduce the gastrointestinal symptoms associated with initial therapy. Apremilast can be administered without regard to meals.
Day 1: 10 mg in morning
Day 2: 10 mg in morning and 10 mg in evening
Day 3: 10 mg in morning and 20 mg in evening
Day 4: 20 mg in morning and 20 mg in evening
Day 5: 20 mg in morning and 30 mg in evening
Day 6: 30 mg twice daily
Dosage adjustment in patients with severe renal impairment. Apremilast dosage should be reduced to 30 mg once daily in patients with severe renal impairment. For initial dosage titration, it is recommended that Apremilast be titrated using only the morning schedule and the evening doses be skipped.
",,"Co-administration of strong cytochrome P450 enzyme inducer Rifampin resulted in a reduction of systemic exposure of Apremilast.Therefore.the use of cytochrome P450 enzyme inducers (e.g. Rifampin, Phenobarbital,Carbamazepine, Phenytoin) with Apremilast is not recommended.
","Apremilast is contraindicated in patients with a known hypersensitivity to Apremilast or to any of the excipients in the formulation.
","The most frequently occurring side effects of Apremilast are nausea, diarrhea and headache. Other less frequent side effects are upper respiratory tract infection, vomiting, naospharyngitis, abdominal pain, hypersensitivity, gastroesophageal reflux disease, dyspepsia, fatigue, decrease appetite, cough, rash, insomnia.
","Pregnancy Category C. It is not known whether Apremilast or its metabolites are present in human milk; however, Apremilast was detected in milk of lactating mice. Caution should be exercised when Apremilast is administered to a nursing woman.
","Treatment with Apremilast is associated with an increase in adverse reactions of depression. Patients, their caregivers and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes and if such changes occur to contact their healthcare provider. Prescribers should carefully evaluate the risks and benefits of continuing treatment with Apremilast if such events occur.
During the controlled period of the studies in psoriatic arthritis, weight decrease between 5-10% of body weight was reported in 10% of subjects treated with Apremilast 30 mg twice daily compared to 3.3% treated with placebo.
","Use in Paediatric patient: The safety and effectiveness of Apremilast in paediatric patients less than 18 years of age have not been established.
",,,,"Store at cool & dry place, protected from light & moisture. Keep the medicine out of the reach of children.
",11
+1400,Apixaban,apixaban-1400,https://medex.com.bd/attachments/hcwqVCcV57fFhqIBNkcGTuH8rP6wVg/apixaban-prescribing-information,Fibrinolytics (Thrombolytics),Venous thrombosis,"Apixaban is a factor Xa inhibitor indicated:
+
+- To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
+- For the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery
... Read more
Apixaban is a factor Xa inhibitor indicated:
+
+- To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
+- For the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery
+- For the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy
+
","Anti-coagulants, Anti-platelet drugs, Fibrinolytics (Thrombolytics), Oral Anti-coagulants
","Apixaban acts by inhibiting coagulation, and thus prevents development of blood clots. As a result of FXa inhibition, apixaban prolongs clotting tests such as prothrombin time (PT), INR, and activated partial thromboplastin time (aPTT). Changes observed in these clotting tests at the expected therapeutic dose, however, are small, subject to a high degree of variability, and not useful in monitoring the anticoagulation effect of apixaban.
","Recommended Dose: The recommended dose of Apixaban for most patients is 5 mg taken orally twice daily.
Dosage Adjustments: The recommended dose of Apixaban is 2.5 mg twice daily in patients with any 2 of the following characteristics: age ≥80 years, body weight ≤60 kg, serum creatinine ≥1.5mg/dl.
CYP3A4 and P-gp inhibitors: When Apixaban is coadministered with drugs that are strong dual inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) (e.g. ketoconazole, itraconazole, ritonavir, clarithromycin) the recommended dose is 2.5 mg twice daily.
Missed Dose: If a dose of Apixaban is not taken at the scheduled time, the dose should be taken as soon as possible on the same day and twice-daily administration should be resumed. The dose should not be doubled to make up for a missed dose.
Discontinuation for Surgery and Other Interventions: Apixaban should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. Apixaban should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be non-critical in location and easily controlled.
Switching from or to Apixaban: Switching from warfarin to Apixaban: Warfarin should be discontinued and Apixaban started when the international normalized ratio (INR) is below 2.0.
Switching from Apixaban to warfarin: Apixaban affects INR, so that INR measurements during co-administration with warfarin may not be useful for determining the appropriate dose of warfarin. If continuous anticoagulation is necessary, discontinue Apixaban and begin both a parenteral anticoagulant and warfarin at the time the next dose of Apixaban would have been taken, discontinuing the parenteral anticoagulant when INR reaches an acceptable range.
Switching between Apixaban and anticoagulants other than warfarin: Discontinue one being taken and begin the other at the next scheduled dose.
",,"Apixaban is a substrate of both CYP3A4 and P-gp. Inhibitors of CYP3A4 and P-gp increase exposure to Apixaban and increase the risk of bleeding. Inducers of CYP3A4 and P-gp decrease exposure to Apixaban and increase the risk of stroke.
","Apixaban is contraindicated in patients with the following conditions: Active pathological bleeding. Severe hypersensitivity reaction to Apixaban (i.e. anaphylactic reactions).
","Apixaban can cause a skin rash or severe allergic reaction.
","Pregnancy: There are no adequate and well-controlled studies of Apixaban in pregnant women. Treatment is likely to increase the risk of hemorrhage during pregnancy and delivery. Apixaban should be used during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus.
Labor and Delivery: Safety and effectiveness of Apixaban during labor and delivery have not been studied in clinical trials. Consider the risks of bleeding and of stroke in using Apixaban in this condition.
Nursing Mothers: It is unknown whether Apixaban or its metabolites are excreted in human milk. Women should be instructed either to discontinue breastfeeding or to discontinue Apixaban therapy, taking into account the importance of the drug to the mother.
","Increased Risk of Stroke with Discontinuation of Apixaban Discontinuing Apixaban in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from Apixaban to warfarin in clinical trials in patients with nonvalvular atrial fibrillation. If Apixaban must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant.
","Hepatic Impairment: No dose adjustment is required in patients with mild hepatic impairment. Because patients with moderate hepatic impairment may have intrinsic coagulation abnormalities and there is limited clinical experience with Apixaban in these patients, dosing recommendations cannot be provided Apixaban is not recommended in patients with severe hepatic impairment
Renal Impairment: The dosing adjustment for moderate renal impairment is described above. No data inform use in patients with creatinine clearance <15 ml/min or on dialysis.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: Of the total subjects in clinical studies of Apixaban, >69% were 65 and older, and >31% were 75 and older. The effects of Apixaban on the risk of stroke and major bleeding compared to warfarin were maintained in geriatric subjects.
","There is no antidote to Apixaban. Overdose of Apixaban increases the risk of bleeding. Activated charcoal may be useful in the management of Apixaban overdose.
",,,"Keep in a dry place and store below 30°C. Protect from light and keep out of the reach of children.
",12
+1895,Apis mellifica + Gelsemium sempervirens + Gnaphalium,apis-mellifica-gelsemium-sempervirens-gnaphalium-1895,,,,"
+- Foot cream for pain relief
+- Soothes damaged nerves and calms itchy and dry skin
+- Intensely moisturizing to improve overall skin health
+- Ideal for diabetics
+- 100% safe to use between the toes
+- Non-greasy formula that absorbs quickly
+- Size: 4 ounces
+
",,"Intense moisturizing treatment developed for severely dry, cracked, itchy and sensitive skin, softens hardened, callused skin to eliminate painful cracks and fissures, and relieves itching. Greaseless formula penetrates deeply. No added dyes, no petroleum or mineral oils. 100% safe to use between the toes.
","Generously apply and massage into all surfaces of the feet, heels, and toes twice daily. Apply to legs as needed.
",,,,,,"
+- Keep null of reach of children
+- For external use only
+- Avoid contact with eyes
+- If symptoms persist for more than 7 days or worsen, consult your physician
+- Do not rise on open wounds, cuts, damaged, or infected skin
+
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",5
+1666,Antioxidants and Micronutrients,antioxidants-and-micronutrients-1666,,Anti-oxidant Multivitamin Multimineral preparations,Spermatogenesis induction,"This is a dietary supplement specifically formulated to meet the nutritional needs of men wishing to have a child. This combination of antioxidants and micronutrients contributes to: healthy fertility and reproduction (zinc), normal spermatogenesis (selenium) and synthesis of DNA (zinc), the protection ... Read more
This is a dietary supplement specifically formulated to meet the nutritional needs of men wishing to have a child. This combination of antioxidants and micronutrients contributes to: healthy fertility and reproduction (zinc), normal spermatogenesis (selenium) and synthesis of DNA (zinc), the protection of cells against oxidative stress (vitamins C, E, selenium). This is a simple and safe way of helping you to have healthy, good quality sperm as it provides the nutritional elements that are necessary to protect and improve your sperm's performance.
","Anti-oxidant Multivitamin Multimineral preparations
","L-Carnitine Tartrate: Carnitine is essential for sperm to mature in the testicles.
Vitamine C (Ascorbic Acid): Vitamin C helps to protect cells against oxidative stress.
Vitamin E (Tocopherol): Vitamin E helps to protect cells against oxidative stress.
Zinc: Contributes to normal reproduction and fertility. Contributes to normal DNA synthesis. Helps to protect cells against oxidative stress
Selenium: Selenium aids normal spermatogenesis: Help protect cells against oxidative stress
Vitamin B9 (Folic Acid): Sperm concentration
Co-enzyme Q10: Helps to protect cells against oxidative stress.
","For to be effective, take 2 capsules per day (1 white+1 green) for a minimum of 3 months, i.e. the average time it takes for the spermatozoa to mature (72 days) plus the 25 days required for them to be able to fertilize. 3 boxes for a 3 months course of treatment. Do not take more than the prescribed daily dose. Using this food supplement does not replace the balance of the variety of foods important to a healthy diet. Inform your doctor of any unwanted or troublesome side-effect.
",,,,,,"The ingredients of this preparation have been authorized by the European Union and scientifically validated by the European Food Safety Authority (EFSA).
+
+- Do not leave within reach of children.
+- Do not take more than the prescribed daily dose.
+- Using this food supplement does not replace the balance of the variety of food important to a healthy diet.
+- Inform your doctor of any unwanted or troublesome side effect
+
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",6
+73,Antihemophilic Factor [Factor VIII],antihemophilic-factor-factor-viii-73,https://medex.com.bd/attachments/ROAnI01VavdXRO56akR3oV6WpnNg6B/antihemophilic-factor-factor-viii-prescribing-information,Antihaemophilic factor,Hemophilia,"Treatment and prophylaxis of haemorrhagic episodes in patients with haemophilia A, Prophylaxis in severe haemophilia A
","Antihaemophilic factor
","Factor VIII is required for clot formation and maintenance of haemostasis. It activates factor X in conjunction with activated factor IX. Activated factor X then converts prothrombin to thrombin, which converts fibrinogen to fibrin, and forms a stable clot with factor XIII. Factor VIII is used for replacement therapy in patients with haemophilia A.
","Treatment and prophylaxis of haemorrhagic episodes in patients with haemophilia A: Dosage is individualised based on coagulation tests performed before treatment and at regular intervals during treatment. Generally, 1 IU/kg will increase circulating factor VIII levels by about 2 IU/dL. Recommended doses vary according to the preparation used
Suggested doses: Mild-moderate haemorrhage (increase to 20-30% of normal): Usually with a single dose of 10-15 IU/kg
More serious haemorrhage or minor surgery (increase to 30-50% of normal): Usual initial dose of 15-25 units/kg followed by 10-15 IU/kg every 8-12 hr if required
Severe haemorrhage or major surgery (increase to 80-100% of normal): Usual initial dose of 40-50 IU/kg followed by 20-25 IU/kg every 8-12 hr. Refer to individual product information for further dosing details
Prophylaxis in severe haemophilia A: 10-50 IU/kg every 2-3 days, as needed
",,"Allergic reactions e.g. chills, chest tightness, fever, headache, hyperfibrinogenaemia, jittery feeling, lethargy, nausea, vomiting, somnolence, stinging at infusion site, stomach discomfort, tingling, urticaria, vasomotor reactions with rapid infusion.
","In individuals who have had an anaphylactic or severe systemic reaction to antihemophilic factor or von Willebrand factor preparations.
","Allergic reactions e.g. chills, chest tightness, fever, headache, hyperfibrinogenaemia, jittery feeling, lethargy, nausea, vomiting, somnolence, stinging at infusion site, stomach discomfort, tingling, urticaria, vasomotor reactions with rapid infusion.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
","Risk of intravascular haemolysis in patients with blood groups A, B, or AB receiving high doses or repeated doses of factor VIII preparations. Risk of transmission of some viral infections especially hepatitis B and C. Dose requirement may vary in patients with factor VIII inhibitors; thus optimal treatment should be based on clinical response. Monitor platelet counts regularly during treatment.
",,,,"Intravenous: Treatment and prophylaxis of haemorrhagic episodes: If refrigerated, warm dried concentrate and diluent to room temperature before reconstitution.
","Store between 2-8° C. Use within 3 hr of reconstitution; do not refrigerate after reconstitution due to risk of precipitation.
",11
+1560,Anti-Thymocyte Globulin,anti-thymocyte-globulin-1560,https://medex.com.bd/attachments/ivkkI6eSGKNFqzThGNWBo9ZKDCX6kT/anti-thymocyte-globulin-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Renal transplant,"Anti-Thymocyte Globulin is an immunoglobulin G indicated for the prophylaxis and treatment of acute rejection in patients receiving a kidney transplant. Use in conjunction with concomitant immunosuppression.
","Vaccines, Anti-sera & Immunoglobulin
","The mechanism of action by which polyclonal antilymphocyte preparations suppress immune responses is not fully understood. Possible mechanisms by which Anti-Thymocyte Globulin may induce immunosuppression in vivo include: T-cell clearance from the circulation and modulation of T-cell activation, homing, and cytotoxic activities. Anti-Thymocyte Globulin includes antibodies against T-cell markers such as CD2, CD3, CD4, CD8, CD11a, CD18, CD25, CD44, CD45, HLA-DR, HLA Class I heavy chains, and ß2 micro-globulin. In vitro, Anti-Thymocyte Globulin (concentrations >0.1 mg/mL) mediates T-cell suppressive effects via inhibition of proliferative responses to several mitogens. In patients, T-cell depletion is usually observed within a day after initiating Anti-Thymocyte Globulin therapy. Anti-Thymocyte Globulin has not been shown to be effective for treating antibody-mediated (humoral) rejections.
","The first dose should be infused over at least 6 hours; doses on subsequent days should be infused over at least 4 hours.
Premedication with corticosteroids, acetaminophen, and/or an antihistamine prior to each infusion is recommended.
The Anti-Thymocyte Globulin dose should be reduced by one half if the white blood cell (WBC) count is between 2,000 and 3,000 cells/mm3 or if the platelet count is between 50,000 and 75,000 cells/mm3. Stopping Anti-Thymocyte Globulin treatment should be considered if the WBC count falls below 2,000 cells/mm3 or if the platelet count falls below 50,000 cells/mm3
+
+- Prophylaxis of acute rejection: 1.5 mg/kg of body weight administered daily for 4 to 7 days
+- Treatment of acute rejection: 1.5 mg/kg of body weight administered daily for 7 to 14 days
+
",,"No drug interaction studies have been performed.
","Allergy or anaphylactic reaction to rabbit proteins or to any product excipients, or active acute or chronic infections which contraindicate any additional immunosuppression
","The most common adverse reactions and laboratory abnormalities (incidence>5% higher than comparator) are urinary tract infection, abdominal pain, hypertension, nausea, shortness of breath, fever, headache, anxiety, chills, increased potassium levels in the blood, low counts of platelets and white blood cells
","Animal reproduction studies have not been conducted with Anti-Thymocyte Globulin. It is also not known whether Anti-Thymocyte Globulin can cause fetal harm. Anti-Thymocyte Globulin should be given to a pregnant woman only if the benefit outweighs the risk.
Anti-Thymocyte Globulin has not been studied in nursing women. It is not known whether this drug is excreted in human milk. Because other immunoglobulins are excreted in human milk, breastfeeding should be discontinued during Anti-Thymocyte Globulin therapy.
","Anti-Thymocyte Globulin should only be used by physicians experienced in immunosuppressant therapy in transplantation.
Immune-mediated reactions: Anti-Thymocyte Globulin infusion could result in an anaphylactic reaction.
Infusion-associated reactions: Close compliance with the recommended infusion time may reduce the incidence and severity of infusion-associated reactions.
Hematologic effects: low counts of platelets and white blood cells have been identified and are reversible following dose adjustments. Monitor total white blood cell and platelet counts.
Infection: Infections and reactivation of infections have been reported. Monitor patients and administer anti-infective prophylaxis.
Malignancy: Incidence of malignancies may increase.
Immunization with attenuated live vaccines is not recommended for patients who have recently received THYMOGLOBULIN. THYMOGLOBULIN may interfere with rabbit antibody–based immunoassays and with cross-match or panel-reactive antibody cytotoxicity assays.
","Pediatric Use: The safety and effectiveness of Anti-Thymocyte Globulin in pediatric patients have not been established in controlled trials. However, based on limited European studies and U.S. compassionate use, the dose, efficacy, and adverse reaction profile are not thought to be different than for adults.
",,,,"Store in refrigerator at 2°C to 8°C. Protect from light. Do not freeze.
",11
+79,Antazoline + Tetryzoline,antazoline-tetryzoline-79,,Other ophthalmic preparations,Keratitis,"Temporary relief of the signs and symptoms of allergic conjunctivitis including conjunctival hyperaemia, chemosis and itching in adults and children above 2 years of age.
","Other ophthalmic preparations
","Antazoline is an anti-histamine of the ethylenediamine class, which are selective HI-antagonist. Effects mediated by HI receptors include the contraction of smooth muscle and the dilation and increased permeability of the capillaries. Tetryzoline is a sympathomimetic with alpha-adrenergic activity. Its vasoconstrictive effect reduces redness and edema in allergic conjunctivitis. Antihistamines, which act by blocking the HI histamine receptor, are highly effective in providing relief of itching but are not very active in relieving the associated redness. The use of products combining an anti-histamine and a vasoconstrictor is well established in the symptomatic relief of allergic eye disease.
","Adults and adolescents: 1 drop 2 to 3 times daily upto 14 days.
Children (Older than 2 years of age): No specific studies are available in this patient group. For possible systemic effects, the dosage should exceed to 1 to 2 drops per day.
Children (Below 2 years of age): Not to be used in children below 2 years of age.
The eye drop should not be used for longer periods than 14 days as this may cause rebound hyperemia and toxic follicular conjunctivitis.
",,"Sympathomimetic agents may cause a hypertensive crisis if used during treatment with MAOIs. Concomitant use with MAOIs is therefore contraindicated. Sedating anti-histamines can enhance the sedating effects of CNS depressant including alcohol, hypnotics, opioid analgesics, anxiolytic sedatives and anti-psycotics. They also have an additive anti-muscarinic action with other anti muscarinic drugs, such as atropine and antidepressant
","Known hypersensitivity to Antazoline/ Tetryzoline or to any of the excipients. Concomitant use with Monoamine Oxidase Inhibitors (MAOI).
","The most common adverse effect is burning/stinging upon installation, which is mild and transient in nature.
","No clinical data on exposed pregnancies are available. The eye drops should only be used if the potential benefits outweigh the risks to the fetus or infant. It is not known whether the either of the active substances of the eye drop passes into breast milk. Caution should be exercised when using the product during breast-feeding.
","The eye drop should be used with caution in elderly patients with severe cardiovascular disease, including arrhythmia, poorly controlled hypertension or diabetes.
",,"A topical overdose of this ophthalmic solution may be flushed from the eye with warm tap water.
",,,"The drug is to be used within 30 days after first opening. Store at 15-25° C. Protect from light. The bottle is to be closed strongly immediately after use. keep out of reach of children.
",11
+1798,Anidulafungin,anidulafungin-1798,https://medex.com.bd/attachments/LeTg57pXKocQyCHo3gwhFG1csw3qWn/anidulafungin-prescribing-information,Echinocandins,Deep tissue candida infections,"Anidulafungin is an echinocandin antifungal indicated for the treatment of the following infections:
+
+- Candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in adults and pediatric patients (1 month of age and older).
+- Esophageal candidiasis in adults.
... Read more
Anidulafungin is an echinocandin antifungal indicated for the treatment of the following infections:
+
+- Candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in adults and pediatric patients (1 month of age and older).
+- Esophageal candidiasis in adults.
+
+Limitations of use:
+
+- Anidulafungin has not been studied in adult and pediatric patients with endocarditis, osteomyelitis, and meningitis due to Candida or in sufficient numbers of neutropenic patients. The dosage of Anidulafungin for the treatment of Candida dissemination into the CNS and the eye has not been established.
+- Anidulafungin is associated with high relapse rates in esophageal candidiasis.
+
","Candida infections, Echinocandins
","Anidulafungin is a semi-synthetic echinocandin with antifungal activity. Anidulafungin inhibits glucan synthase, an enzyme present in fungal, but not mammalian cells. This results in inhibition of the formation of 1,3-β-D-glucan, an essential component of the fungal cell wall.
","Candidemia and other forms of Candida infections-
+
+- Adults: 200 mg loading dose on Day 1, followed by 100 mg once daily maintenance dose thereafter for at least 14 days after the last positive culture.
+- Pediatric Patients 1 Month of Age and Older: 3 mg/kg (not to exceed 200 mg) loading dose on Day 1, followed by 1.5 mg/kg (not to exceed 100 mg) once daily maintenance dose thereafter for at least 14 days after the last positive culture.
+
+Esophageal candidiasis-
+
+- Adults: 100 mg loading dose on Day 1, followed by 50 mg once daily maintenance dose thereafter for a minimum of 14 days and for at least 7 days following resolution of symptoms.
+- Pediatric Patients 1 Month of Age and Older: Not Approved.
+
+
Rate of Infusion for Adults and Pediatric Patients: The rate of infusion should not exceed 1.1 mg/minute [equivalent to 1.4 mL/minute or 84 mL/hour when reconstituted and diluted per instructions]
",,"Cyclosporine: Administration of multiple doses of anidulafungin and cyclosporine to healthy subjects resulted in no significant alteration in the steady state pharmacokinetics of either drug. No dosage adjustment of cyclosporine or anidulafungin is needed when the two drugs are co-administered.
Voriconazole: Administration of multiple doses of anidulafungin and voriconazole to healthy subjects resulted in no significant alteration in the steady state pharmacokinetics of either drug. No dosage adjustment of voriconazole or anidulafungin is needed when the two drugs are co-administered.
Tacrolimus: Administration of multiple doses of anidulafungin and a single-dose of tacrolimus to healthy subjects resulted in no significant alteration in the steady state pharmacokinetics of either drug. No dosage adjustment of tacrolimus or anidulafungin is needed when the two drugs are co-administered.
Rifampin: Administration of multiple doses of anidulafungin and rifampin to patients resulted in no significant alteration in the steady state pharmacokinetics of anidulafungin. No dosage adjustment of anidulafungin is needed when it is co administered with rifampin.
Amphotericin B Liposome for Injection: Administration of multiple doses of anidulafungin and liposomal amphotericin B to patients resulted in no significant alteration in the steady state pharmacokinetics of anidulafungin. No dosage adjustment of anidulafungin is needed when it is co-administered with liposomal amphotericin B.
","Anidulafungin is contraindicated in:
+
+- Patients with known hypersensitivity to anidulafungin, any component of Anidulafungin, or other echinocandins.
+- Patients with known or suspected Hereditary Fructose Intolerance (HFI).
+
","Adults-
+
+- Candidemia and other forms of Candida infections: Most common adverse reactions (≥15%) are hypokalemia, nausea, diarrhea, vomiting, pyrexia, insomnia, hypotension.
+- Esophageal candidiasis: Most common adverse reactions (≥5%) are diarrhea, pyrexia, anemia, headache, vomiting, nausea, dyspepsia, oral candidiasis, and hypokalemia.
+
+Pediatric Patients (1 month and older): Candidemia and other forms of Candida infections: Most common adverse reactions (≥ 5%): diarrhea, vomiting, pyrexia, abdominal pain, anemia, thrombocytopenia, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) increased, hypoglycemia, epistaxis, and rash.
","Pregnancy: Based on findings from animal studies, Anidulafungin can cause fetal harm when administered to a pregnant woman. There are no available human data on the use of Anidulafungin in pregnant women to inform a drug-associated risk of adverse developmental outcomes. In animal reproduction studies fetal toxicity was observed in the presence of maternal toxicity when anidulafungin was administered to pregnant rabbits during organogenesis at 4 times the proposed therapeutic maintenance dose of 100 mg/day on the basis of relative body surface area. Inform pregnant woman of the risk to the fetus.
Lactation: There are no data on the presence of anidulafungin in human milk, the effects on the breastfed infant or the effects on milk production. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Anidulafungin was found in the milk of lactating rats. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Anidulafungin and any potential adverse effects on the breastfed child from Anidulafungin or from the underlying maternal condition.
","Hepatic Effects: Risk of abnormal liver tests, hepatitis, hepatic failure; monitor hepatic function during therapy.
Hypersensitivity: Anaphylaxis, including shock has been reported. Risk of infusion-related adverse reactions, possibly histamine-mediated, including rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, and hypotension; to reduce occurrence, do not exceed a rate of infusion of 1.1 mg/minute.
Risk of Neonatal Toxicity Associated with Polysorbates: Anidulafungin contains polysorbate 80, an inactive ingredient. Thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension and metabolic acidosis haves been reported in low-birth weight infants receiving high doses of polysorbate. Anidulafungin is not approved in pediatric patients younger than 1 month of age.
Hereditary Fructose Intolerance (HFI): Anidulafungin contains fructose. Risk of metabolic crisis with life-threatening hypoglycemia, hypophosphatemia, lactic acidosis, and hepatic failure. Obtain history of HFI symptoms in pediatric patients before Anidulafungin administration.
","Pediatric Use: The safety and effectiveness in patients younger than 1 month of age has not been established.
Geriatric Use: Dosage adjustments are not required for geriatric patients.
Hepatic Insufficiency: No dosing adjustments are required for patients with any degree of hepatic insufficiency.
Renal Insufficiency: Dosage adjustments are not required for patients with any degree of renal insufficiency including those on hemodialysis.
","During clinical trials a single 400 mg dose of Anidulafungin was inadvertently administered as a loading dose. No clinical adverse events were reported. In a study of 10 healthy subjects administered a loading dose of 260 mg followed by 130 mg daily; 3 of the 10 subjects experienced transient, asymptomatic transaminase elevations (≤3 x ULN)
Anidulafungin is not dialyzable. The maximum non-lethal dose of anidulafungin in rats was 50 mg/kg, a dose which is equivalent to 10 times the recommended daily dose for esophageal candidiasis (50 mg/day) or equivalent to 5 times the recommended daily dose for candidemia and other Candida infections (100 mg/day), based on relative body surface area comparisons.
",,,"Anidulafungin vials: Anidulafungin vials should be stored in a refrigerator at 2°C-8°C. Do not freeze. Excursions for 96 hours up to 25ºC are permitted, and the vial can be returned to storage at 2°C-8°C.
Reconstituted solution: Anidulafungin reconstituted solution can be stored at up to 25°C for up to 24 hours.
Infusion Solution: Anidulafungin infusion solution can be stored at temperatures up to 25°C for up to 48 hours. Do not freeze.
",12
+1518,Nabayas Louha Herbal Haematinic,nabayas-louha-herbal-haematinic-1518,,Herbal and Nutraceuticals,Iron deficiency anemia,"Nabayas Louha is indicated in iron deficiency anemia, anemia due to malnutrition, loss of appetite and debility
","Herbal and Nutraceuticals
","Zingiber officinale: Principal constituents are Zingiberene (α and β zingiberene) and zingiberol used as a carminative and stimulant to the gastro-intestinal tract. It has antiflatulent effect.
Piper nigrum: Principal constituents are piperine, chavicine, piperidine and piperettine. It is a stimulant and used in dyspepsia and flatulence.
Terminalia chebula: Principal constituents are chebulagic acid, chebulinic acid and corilagin. It acts as a gentle laxative and helps in smooth evacuation.
Emblica officinalis: It is also called Amalaki. Fruit contains phyllembin and curcuminoides. It is rich in nutrition, vitamin C, minerals and amino acids. It increases absorption of iron. In combination with iron, it is used as a remedy for anemia and jaundice.
Terminalia bellirica: Fruit bark contains β-sitosterol, gallic acid and chebulagic acid. It is used in dropsy, piles and diarrhea.
Cyperus rotundus: The major constituent is cyperine. It is carminative, stomachic and stimulant.
Plumbago zeylanica: The root bark contains plumbagin. It has been used in anemia and rheumatism.
Cuminum cyminum: It contains large amount of zinc and folic acid.
Carbonyl Iron: Indicated in anemia, fatigue, stunted growth, increased maternal morbidity, and fetal distress.
","Adult: 1 capsule should be taken daily before meal.
Children: Not recommended for children under 12 years of age.
",,"No clinically important drug interactions have been reported.
","There is no evidence available on contraindication but it may rarely happen in patients who are hypertensive to any of its ingredients.
","Nabayas Louha capsules are not known to have any side effects if taken as per prescribed dosage.
","The safety of Nabayas Louha capsule in pregnancy has not been established. Therefore, it should be used with caution during pregnancy and only if the benefits to the mother is higher than the risks to fetus.
Studies not available concerning the passes of the ingredients of Nabayas Louha capsule into breast milk. Though it is not documented but for the safety it should be used with caution for nursing mothers according to the advice of a physician,
",,,,,,"Store in cool and dry place away from direct sunlight. Keep the medicine out of reach of children.
",9
+1741,"Mustakarista [Cyperus, Zingiber, Piper nigrum]",mustakarista-cyperus-zingiber-piper-nigrum-1741,,Herbal and Nutraceuticals,Indigestion,"This is indicated in-
+
+- Dyspepsia
+- Anorexia
+- Diarrhoea
+- Dysentery
+- Chronic dysentery
+- Indigestion
+
","Herbal and Nutraceuticals
","Cyperus rotundus-
+
+- Chemical constituents: Cyperene-1 and cyperene-2, cyperotundone, ß-selinene, cyperenone, α-cyperone etc.
+- Actions: It is used as stimulant, emmenagogue, diaphoretic and diuretic. It is used in stomach disorder and bowel irritation.
+
+Zingiber officinale-
+
+- Chemical constituents: Terpenes, cineol, borneol, citral, camphene, phelandrene, gingerol, shogaol, zingerfone, zinziberin etc.
+- Actions: It is used as aromatic, stimulant, carminative. It is used in dyspepsia, flatulent, colic and vomiting.
+
+Piper nigrum-
+
+- Chemical constituents: Alkaloids-chavicine, piperine, piperidine, piperitine; gum, starch, fat, essential oil etc.
+- Actions: It refreshes entire human body. It is used as carminative and enhances the activity of vital organs.
+
","Adult: 2-4 tea-spoonful 2 - 3 times daily after meal.
Children: 1-2 tea-spoonful 2 -3 times daily after meal.
",,,"There is no absolute contraindication.
",,,,,,,,"Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.
",6
+1696,Mumshik,mumshik-1696,,Herbal and Nutraceuticals,Premature ejaculation,"Mumshik is indicated in-
+
+- Physical & nervous debility
+- Premature ejaculation
+- Spermatorrhoea
+- Paralysis
+- Facial paralysis
+- Loss of sensation.
+
","Herbal and Nutraceuticals
","Mumshik is a powerful aphrodisiac capsule. Unique formulation of Mumshik with the combination of precious natural ingredients makes it a safe and effective nervine tonic, cephalic tonic, cardio tonic, hepato tonic & sexual tonic.
","2 capsules 1-2 time(s) daily or as prescribed by the registered physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in therapeutic dosage.
",,"Keep out of reach of children.
",,,,,"Store in a cool and dry place away from light.
",8
+1725,"Mudir [Aloe, Saffron, Ferrus sulphate]",mudir-aloe-saffron-ferrus-sulphate-1725,,Herbal and Nutraceuticals,Secondary amenorrhoea,"This is indicated in amenorrhoea.
","Herbal and Nutraceuticals
","This is a special preparation of synergistically acting natural ingredients such as Aloe (Aloe barbadensis), Saffron (Crocus sativus) and other natural ingredients. It helps to prevent amenorrhoea, irregular menstruation, and other female disorders. It strengthens & maintains the normal function of uterus.
","1-2 tablet(s) 3 times daily, from 3-4 days before to start menstrual cycle, not to be taken if the menstrual cycle started or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in the therapeutic dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1750,Monjistha [Rubia cordifolia],monjistha-rubia-cordifolia-1750,,Herbal and Nutraceuticals,Oedema,"This is indicated in Dysmenorrhoea, Oligomenorrhea, Metritis, Edema.
","Herbal and Nutraceuticals
","Monjistha (Rubia cordifolia) has a marked effect on the female reproductive organs. It is useful in the treatment of various gynecological problems, like oligomenorrhea, irregular menstruation and dysmenorrhea. It stimulates and cleanses the uterus; so useful in postnatal ailments.
","1-2 tablets two times daily.
",,,"Not to be used during pregnancy.
","Not known.
",,,,,,,"Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.
",7
+1223,Menthol + Camphor + Methyl Salicylate + Oleoresin Capsicum,menthol-camphor-methyl-salicylate-oleoresin-capsicum-1223,,Topical Analgesics,Strains,"Muscle pain Sprains, strains and sports injuries, headache bruising, fibrositis, neuralgia, pain due to herpes zoster, osteoarthritis
","Herbal and Nutraceuticals, Topical Analgesics, Topical anti-inflammatory preparations
","Capsicum species are known to be very strong local stimulants in the circulatory system. Its reduction of thromboxane B2 formation and erythrocyte hemolysis suggests a membrane stabilizing property that interferes with the activation of phospholipase A2. Capsicum activates nociceptive fbres, which induces the release of excitatory neurotransmitters, bind to specific vanilloid (capsaicin) receptors and its effects are reversible. Capsicum induces selective analgesic effect by depleting substance P, a neuropeptide of 11 amino acids that mediates the transmission and modulation of pain impulses from the peripheral nerves to the spinal column. Capsicum initially stimulates substance P release from peripheral sensory C type nerve fibers, then prevents its re-uptake and also blocks its transport within the neuron, which causes its eventual depletion resulting in analgesia.
Methyl salicylic acid is similar to that of Aspirin that shows anesthetic properties by blocking the voltage-operated sodium channels in pain-receptor neurons.
Menthol molecule binds and stimulates the TRPM-8 receptor protein that produces a sensation of cold (pain in extreme cases) when stimulated.
Camphor has been approved by FDA for topical use as a pain reliever and anesthetic. It acts as counter irritant and numbs the nerve endings that inhibit the transmission of pain sensation.
","Adult: Clean the affected area. Apply a small amount of this cream to the surface area of the tip of a finger 3 to 4 times daily or as directed by the physician.
Children under 6 years of age: Not to be used.
","In rare cases hypersensitivity reaction may occur. Inhalation of medicine may cause bronchoconstriction.
",,"Capsicum preparations are contraindicated for application on injured skin, allergies to aspirin, allergic inflammation of skin, eczema, itchy rash and near the eyes.
",,"There is no information available about restriction of this medicine during pregnancy and lactation. May be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks of fetus.
","Avoid use on broken or inflamed skin, eyes and the mucous membranes. Rinse with cold water if accidental contact occurs. Do not cover immediately after application. Wash your hands thoroughly after application. If itching or irritation occurs discontinue it.
",,,,,"Store at a cool, dry place and away from direct sunlight. Keep the medicine out of the reach of children.
",9
+1529,Menthol + Camphor + Eucalyptus Oil + Mint Oil,menthol-camphor-eucalyptus-oil-mint-oil-1529,,Herbal and Nutraceuticals,Shoulder pain,"This cream is indicated-
+
+- Pain in neck and shoulder
+- Pains in Muscles and joints
+- Relief of minor aches
+
","Herbal and Nutraceuticals
","Menthol is a vasodilator. It dilates the blood vessels,produces a feeling of coolness and produces analgesia. Camphor is topically used as a pain reliever. It acts as counter irritant and numbs the nerve endings that inhibit the transmission of pain sensation. Eucalyptus Oil is highly active against rheumatic complaints. Moreover mint oil provides relief from myalgia and neuralgia.
","For adults and children over 12 years old: Rub well on the affected area. Repeat 3 to 4 times daily. For children 12 years of age or younger, consult a healthcare professional before use.
",,"Not known.
","Not recommended for infant & young children
","Not known.
","Should be used with caution or seek the advice of a healthcare professional before use.
","
+- For external use only.
+- Use only as directed
+- Avoid contact with eyes and mucous membranes
+- Do not apply to wounds,damaged or irritated skin
+- Do not bandage or cover with wrap or use heating pad
+- Do not use 1 hour prior to bathing or within 30 minutes after bathing
+
",,,,,"Store in a cool & dry place, below 30°C. Protect from light & moisture. Keep all medicine out of the reach of children.
",10
+1748,Mentha + Cinnamomum + Gaultheria + Capsicum,mentha-cinnamomum-gaultheria-capsicum-1748,,Herbal and Nutraceuticals,Stiffness,"Effective in aches including headache and pain for muscular stiffness, Rheumatic pains, Gout, Bruising, Sprains and Fibrositis.
","Herbal and Nutraceuticals
","Mentha piperita- It contains peppermint oil- menthol (35-45%), menthone (15-20%) and menthyl acetate (3-5%). It has analgesic, antibacterial and insecticidal effects. Moreover, Mentha piperita has the cooling effect on the skin and is equally effective as acetaminophen in relieving headaches.
Cinnamomum camphora- It contains essential oil- sesquiterpenes camphorenone and campherenol. It has antispasmodic, bronchial secretolytic and hyperemic effect. It acts beneficialy in gout, rheumatic pains, neuralgia. It can be safely applied externally in all cases of inflammation, bruises and sprains.
Gaultheria procumbens- It contains volatile oil- methyl salicylate (96-98%) and has rubefacient effect that administered in the treatment of rheumatoid arthritis and related condition.
Capsicum annum- It contains capsaicinoids- capsaicin (32-38%), dihydro-capsaicin (18-52%) and volatile oil (0.1%). It has analgesic, powerful local irritant and rubefacient effects. The most important active ingredient of capsaicinoids is capsaicin, which relieves pain by depleting neuropathies. It enriches blood, lessens inflammation and pain.
","Apply topically to the affected area 2 to 3 times daily. Or as directed by the physician.
",,"No data available.
","There is no absolute contraindication.
","Not yet known.
","No restriction is known yet.
",,,,,,"Keep all medicines out of the reach of children. Store in a cool and dry place, protected from light.
",9
+1687,Marwareedi,marwareedi-1687,,Herbal and Nutraceuticals,Vaginal leucorrhoea,"Marwareedi is indicated in-
+
+- General debility
+- Nervous debility
+- Leucorrhoea
+- Menstrual irregularity
+- Dysmenorrhoea
+- Metritis
+
","Herbal and Nutraceuticals
","Marwareedi is a well known unani medicine. It acts as general tonic & nervine tonic. Marwareedi is also effective in leucorrhoea, menstrual irregularity, dysmenorrhoea and metritis.
","1-2 tablet(s) twice daily with milk or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+2062,Marine Collagen,marine-collagen-2062,,Specific mineral preparations,,"Cozen improves skin health by reducing wrinkles and stretch marks and improved skin hydration and firmness. It supports skin health by repairing skin collagen and produces a significant thickening of the outer skin surface (epidermis). It supports stronger hair and nails. It reduces nail brittleness ... Read more
Cozen improves skin health by reducing wrinkles and stretch marks and improved skin hydration and firmness. It supports skin health by repairing skin collagen and produces a significant thickening of the outer skin surface (epidermis). It supports stronger hair and nails. It reduces nail brittleness and promotes strength & growth of nails. It helps in preventing hair thinning (associated with aging), slow graying, build hair strengthen & imparts shine to hair. It plays important antioxidant roles by protecting against free radicals that cause cell damage. It protects against oxidative skin damage caused by ultraviolet (UV) light (sunlight) and protects sunburn. It strengthen bones, joints & ligaments, improves mobility in joints, reduces pain & stiffness for smoother joint functioning and also minimize the risk for future fractures or injuries. It is useful for healthy muscles.
","Specific mineral preparations
","Marine fish collagen is a complex structural protein that helps maintain the strength and flexibility of skin, ligaments, joints, bones, muscles, tendons, blood vessels, gums, eyes, nails and hair. It has very specific amino acid compositions with a high concentration of glycine, hydroxyproline and proline. When it is ingested, hydroxyproline peptides are not completely digested to free amino acids and can be detected in the blood. These hydroxyproline peptides stimulate cells in the skin, joints and bones and lead to collagen synthesis through cell activation and growth.
","1-2 capsules daily preferably with meal. Or, as directed by the registered physician.
",,,"It is contraindicated in patients with hypersensitivity to any component of this capsule.
","This capsule is generally well tolerated. No significant side effects have been observed in therapeutic dosage.
",,,,,,,"Keep out of reach of children. Keep away from direct sunlight. Store below 30°C in a dry place.
",7
+1692,Marham Kharish,marham-kharish-1692,,Herbal and Nutraceuticals,Scabies,"Marham Kharish is indicated in-
+
+- Scabies
+- Itching
+- Pustular
+- Piles
+- Eczema
+- Proriasis
+- Ring worm
+- Skin eruption and burn
+
","Herbal and Nutraceuticals
","Marham Kharish is a unique combination of Camphor (Cinnamomum camphora), Henna (Lawsonia inermis), Catechu (Acacia catechu) and others natural ingredients. It acts as antiseptic, anti-inflammatory and anti-microbial. Marham Kharish is very effective in scabies, itching, pustular, piles, boils, eczema and proriasis.
","Rub gently the affected area and 2 to 4 times daily or as directed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Keep from light. Keep in cool and dry place.
",8
+1846,Malus sylvestris,malus-sylvestris-1846,,Herbal and Nutraceuticals,General weakness,"এই সিরাপ নিম্নোক্ত উপসর্গে নির্দেশিত-
+
+- সাধারণ দুর্বলতা
+- মানসিক দুর্বলতা
+- হৃৎপিন্ডের দুর্বলতা
+- লিভারের দুর্বলতা
+- ক্ষুধামান্দ্য
+- অজীর্ণতা
+- রক্তাল্পতা
+- ভিটামিন এ এবং সি এর অভাব
+- হৃদকম্প।
+
","Herbal and Nutraceuticals
","এই সিরাপের মূল্যবান প্রাকৃতিক উপাদান যেমন- আপেলের নির্যাস, মৌরি, দারচিনি, বড় এলাচ, জায়ফল ও লেবুর রসের অপূর্ব সমন্বয়ে প্রস্তুত একটি বিশেষ ফর্মুলেশন, যা দেহের প্রধান অঙ্গসমূহের শক্তি বৃদ্ধিতে অত্যন্ত কার্যকরী ভূমিকা রাখে। আপেলিন শক্তিশালী অ্যান্টিঅক্সিডেন্ট, হৃৎপিন্ডের শক্তিবর্ধক, লিভারের শক্তিবর্ধক ও প্রিবায়োটিক। আপেলিন হজম প্রক্রিয়াকে উন্নত করে, ক্ষুধাবর্ধক হিসেবে কাজ করে এবং রক্তাল্পতার চিকিৎসায় কার্যকরী।
","প্রাপ্ত বয়ষ্ক: ৬ চা-চামচ (৩০ মিলি) দৈনিক ২ বার অথবা রেজিস্টার্ড চিকিৎসকের পরামর্শমত সেব্য।
অপ্রাপ্ত বয়ষ্ক: ২ চা-চামচ (১০ মিলি) দৈনিক ২ বার অথবা রেজিস্টার্ড চিকিৎসকের পরামর্শমত সেব্য।
",,,,"নির্ধারিত মাত্রায় সেবনে কোন উল্লেখযোগ্য পার্শ্ব প্রতিক্রিয়া পরিলক্ষিত হয়নি।
",,,,,,,"আলো ও আর্দ্রতা থেকে দূরে, ৩০ ডিগ্রী সেঃ তাপমাত্রার নীচে রাখুন। শিশুদের নাগালের বাইরে রাখুন।
",6
+1530,Mahadrakkharist [Grape extract],mahadrakkharist-grape-extract-1530,,Herbal and Nutraceuticals,Tuberculosis,"
+- Chronic obstructive pulmonary diseases(COPD)
+- Asthma (both allergic and cardiac asthma)
+- Pulmonary fibrosis
+- Pulmonary tuberculosis
+
","Herbal and Nutraceuticals
","Grapes contain beneficial bioflaVonoid-like ingredients called ""proanthocyanidins"" (PCOs or OPCs). Proanthocyanidins are believed to protect cell membranes by neutralizing particularly harmful free radicals called ""lipid peroxides"". PCOs may strengthen the capillary walls and skin. It has been reported to inhibit the release of inflammatory chemicals, such as histamine and prostaglandins. PCOs have been used in allergies and asthma because of their reported ability to slow histamine release from mast cells. Resveratrol, a molecule has antioxidant and anti-inflammatory properties that may protect against COPD and asthma (Wood 2010). A cell culture study found that resveratrol inhibited the release of all measured inflammatory mediators (cytokines) from immune cells extracted from the alveoli of smokers and non-smokers with COPD. Moreover, while resveratrol attenuates the release of inflammatory mediators in airway smooth muscle cells, it preserves signaling of a protein called vascular endothelial growth factor (VEGF), which may be protective against emphysema. More recently, the anti-inflammatory effects of resveratrol have been associated with inhibition of the transcription factor NF-kB, possibly mediated via the inhibition of l-kB kinase.
Resveratrol has several activities that may account for its possible cardioprotective action. These include inhibition of the oxidation of low-density lipoprotein (LDL), inhibition of smooth muscle cell proliferation and inhibition of platelet aggregation. Resveratrol also has been found to exert a strong inhibitory effect on superoxide anion and hydrogen peroxide production by macrophages stimulated by lipopolysaccharides or phorbol esters. It also increases nitric oxide and decreases lactate dehydrogenase levels in the carotid blood and effective against ischemia-reperfusion induced arrythmias. Triterpenes roxburghiadiol A and B isolated from this plant Aglaia roxburghiana has the potent anti-inflammatory activity and mast cell degranulation induced by A. roxburghiana extracts and the triterpenes.
Pharmacokinetics: From animal and limited human studies,it appears that resveratrol is absorbed from the gastrointestinal tract following its ingestion. Resveratrol is found in the form of a glucuronide conjugate after crossing the small intestine and entering the blood circulation. In case of human, five metabolites of resveratrolTiave been detected in urine, such as resveratrol monosulphate, two isomeric forms of resveratrol monoglucuronide, dihydroresveratrol monosulphate and dihydroresveratrol monoglucuronide. 56% sulphate and glucuronide conjugates excrete through urine (Baur and Sinclair,2006)
","Mahadrakkharist content of grapes is partly responsible for the therapeutic effect. The Daily recommended dose of resveratrol is 8 mg/kg body weight. Each 5 ml syrup contains 36 mg resveratrol as a fluid extract. So the daily recommended dose is-
+
+- Children under 12 years: 1-2 teaspoonfuls (5-10 ml) 2 times daily after meal.
+- Above 12 years and Adult: 3-4 teaspoonfuls (15-20 ml) 2 times daily after meal for 4-8 weeks or as directed by the physician.
+
",,"It should be used cautiously in patients taking anticoagulants such as warfarin, aspirin, non-steroidal anti inflammatory drugs (NSAIDS), ACE inhibitors or anti-platelet agents. Based on animal studies, grape seed may increase the risk of bleeding. PCOs may theoretically alter the effectiveness of prescribed blood pressure medications that are angiotensin converting enzyme (ACE) inhibitors.
",,"There are no side effects associated with the use of Drakkha in the above-mentioned therapeutic doses. Drakkha has been used safely as an ayurvedic medicine for hundreds of years. But in very rare case stomach pain, headache and an allergic reaction have been reported.
","Women who are pregnant or nursing are advised to consult with a physician prior to use Mahadrakkharist. Although medical literature has no report of adverse effects related to fetal development during pregnancy or to infants who are breast-fed.
","Drakkha is well tolerated but caution should be taken in hypertension, liver disease, alcohol dependence and diabetes. Patients with any medical conditions should talk to their doctors before taking Mahadrakkharist. Lactobacillus products (e.g. Probiotics) should be taken 2 or more hours apart.
",,,,,"Keep in a cool, dry place & away from direct sunlight. Keep the medicine out of the reach of children
",9
+1537,Lutein + Zeaxanthin,lutein-zeaxanthin-1537,,Herbal and Nutraceuticals,Macular Degeneration,"
+- Age related macular degeneration (AMD)
+- Cataracts
+- Retinitis pigmentosa
+
","Herbal and Nutraceuticals
","Lutein and Zeaxanthin are nutritionally important carotenoids that protect healthy cells from oxidative stress and free radical damage. Lutein and Zeaxanthin have immunostimulant and photoprotectant properties. Recent research has shown that these important carotenoids are major eye pigments of the retina. Lutein and Zeaxanthin are especially concentrated in rods which are specialized light sensitive cell or photoprotector in retina and responsible for black and white vision in the dark. Scientific evidence clearly suggests that Lutein and Zeaxanthin has important role in the retina to protect tissue from the damaging effects of high-energy blue spectrum light. The uncontrolled generation of free radicals in the eye and harmful light are believed to ultimately lead to age related macular degeneration (AMD), cataracts, retinitis pigmentosa. Lutein and Zeaxanthin may also have effects on skin health and anti-aging activity.
","1 capsule daily or as advised by the physician.
",,"Certain drugs have been reported to decrease absorption of Lutein and Zeaxanthin. Proton-pump inhibitors and lipid lowering drugs may reduce the absorption of carotenoids.
","No toxicities have been reported in the scientific literature for Lutein and Zeaxanthin at doses up to 40 mg for 2 months.
","No adverse side effects have been reported. Ames testing has demonstrated an absence of any mutagenic effects for purified Lutein and Zeaxanthin.
","Studies on Lutein and Zeaxanthin in pregnant and nursing women have not been conducted.
",,,,,,"Store in a cool and dry place, away from light and moisture. Keep out of reach of children.
",9
+1710,Liquorice + Cascara Sagrada + Belladona,liquorice-cascara-sagrada-belladona-1710,,Herbal and Nutraceuticals,Enuresis,"This is indicated in-
+
+- Spermatorrhoea
+- Painful micturations
+- Nocturnal emission
+- Enuresis
+- Abnormal sensation and weakness of male organ
+
","Herbal and Nutraceuticals
","This is a very effective preparation of Liquorice (Glycyrrhiza glabra), Cascara sagrada (Rhamnus purshiana) and Belladonna (Atropa belladona) for nocturnal emission & spermatorrhoea.
","1 teaspoonful 2-3 times daily after meal or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place protect from light.
",8
+1679,Azelastine Hydrochloride (Eye drop),azelastine-hydrochloride-eye-drop-1679,https://medex.com.bd/attachments/OTQOzpJqbB93lA7noR59xznlXpXjAR/azelastine-hydrochloride-eye-drop-prescribing-information,Anti-histamine Preparations,Conjunctivitis,"Treatment and prevention of the symptoms of seasonal allergic conjunctivitis in adults and children 4 years and older. Treatment of the symptoms of non-seasonal (perennial) allergic conjunctivitis in adults and children 12 years and older.
","Anti-histamine Preparations
","Azelastine Eye drops contains the active substance azelastine hydrochloride, which belongs to a group of medicines called antiallergics (antihistamines). Antihistamines work by preventing the effects of substances such as histamine that the body produces as part of an allergic reaction. Azelastine has been shown to reduce inflammation of the eye.
Azelastine, a phthalazinone derivative is classified as a potent long-acting anti-allergic compound with selective H1 antagonist properties. An additional anti-inflammatory effect could be detected after topical ocular administration. Data from in vivo (pre-clinical) and in vitro studies show that Azelastine inhibits the synthesis or release of the chemical mediators known to be involved in early and late stage allergic reactions e.g. leukotriene, histamine, PAF and serotonin.
","Seasonal allergic conjunctivitis: The usual dosage in adults and children 4 years and older is one drop in each eye twice daily that can be increased, if necessary to four times daily. If allergen exposure is anticipated Azelastine hydrochloride Eye drops, solution should be administered prophylactically, prior to the exposure.
Non-seasonal (perennial) allergic conjunctivitis: The usual dosage in adults and children 12 years and older is one drop in each eye twice daily that can be increased, if necessary to four times daily.
As safety and efficacy have been demonstrated in clinical trials for a period of up to 6 weeks, the duration of any course should be limited to a maximum of 6 weeks. Patients should be advised to contact their doctor if symptoms worsen or do not improve after 48 hours.
",,"No specific interaction studies have been performed. Interaction studies at high oral doses of Azelastine have been performed however they bear no relevance to Azelastine hydrochloride Eye drops, solution, as systemic levels, after administration of the eye drops, are in the picogram range.
","Hypersensitivity to the active substance or to any of the excipients of this preparation.
",,"There is insufficient information available to establish the safety of azelastine in human pregnancy. At high oral doses azelastine has shown to induce adverse effects (foetal death, growth retardation and skeletal malformation) in experimental animals. Local ocular application will result in minimal systemic exposure (picogram range). However, caution should be exercised when using Azelastine hydrochloride Eye drops, solution during pregnancy. Azelastine is excreted into the milk in low quantities. For that reason Azelastine hydrochloride Eye drops, solution is not recommended during lactation.
","Azelastine hydrochloride Eye drops, solution is not intended for treatment of eye infections. Azelastine hydrochloride Eye drops, solution contains the preservative benzalkonium chloride. Benzalkonium chloride may cause eye irritation, especially with dry eyes or disorders of the cornea. Contact with soft contact lenses should be avoided. Contact lenses should be removed prior to application and the patient should wait at least 15 minutes before reinsertion. Known to discolour soft contact lenses.
",,"No specific reactions after ocular overdosage are known, and with the ocular route of administration, overdosage reactions are not anticipated. There is no experience with the administration of toxic doses of azelastine hydrochloride in humans. In the case of overdose or intoxication, disturbances of the central nervous system are to be expected based on the results of animal experiments. Treatment of these disorders must be symptomatic. There is no known antidote.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+97,Azelaic Acid,azelaic-acid-97,https://medex.com.bd/attachments/TfNXe59z5kk3utXJJloQG8vmg5BPWc/azelaic-acid-20-cream-prescribing-information,Acne treatment preparations,Rosacea,"Azelaic Acid cream is indicated for the topical treatment of mild to moderate inflammatory acne vulgaris.
","Acne treatment preparations
","Azelaic acid has been shown to possess antimicrobial activity against Propionibacterium acnes and Staphylococcus epidennidis. The antimicrobial action may be attributable to the inhibition of microbial cellular protein synthesis. A normalization of keratinization leading to an anticomedonal effect of Azelaic acid may also contribute to its clinical activity.
","After the skin is thoroughly washed and patted dry, a thin film of Azelaic Acid should be gently but thoroughly massaged into the affected areas twice daily, in the morning and evening. The hands should be washed following application. Safety and effectiveness in pediatric patients under 12 years of age have not been established. Or as directed by the physician.
",,,"Azelaic acid is contraindicated in individuals who have shown hypersensitivity to any of its components.
","Local skin irritation (e.g. erythema, scaling, itching or burning) occurs in occasional cases, usually at the start of treatment. However, in the majority of cases the irritation is mild and regresses as treatment continues.
","FDA Pregnancy Category B. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Azelaic acid is administered to a nursing mother.
","For external use only. If Azelaic acid comes into contact with the eyes they should immediately be thoroughly rinsed with copious amounts of water. The patients should consult a physician if eye irritation persists.
",,,,,"Store in a cool & dry place protected from light. Keep ail medicines out of reach of children.
",9
+96,Azathioprine,azathioprine-96,https://medex.com.bd/attachments/Y5b1CLApTjPuojyCgofJjw6BP5vxGM/azathioprine-prescribing-information,Cytotoxic immunosuppressants,Vasculitis,"Azathioprine is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms.
Renal Homotransplantation: Azathioprine is indicated as an ... Read more
Azathioprine is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms.
Renal Homotransplantation: Azathioprine is indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a 5-year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti-donor or anti-B-cell alloantigen antibody, and other variables. The effect of Azathioprine on these variables has not been tested in controlled trials.
Rheumatoid Arthritis: Azathioprine is indicated for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms. Aspirin, non-steroidal anti-inflammatory drugs and/or low dose glucocorticoids may be continued during treatment with Azathioprine. The combined use of Azathioprine with disease modifying anti-rheumatic drugs (DMARDs) has not been studied for either added benefit or unexpected adverse effects. The use of Azathioprine with these agents cannot be recommended.
","Cytotoxic immunosuppressants
","Azathioprine antagonizes purine metabolism and may inhibit synthesis of DNA, RNA, and proteins. It may also interfere with cellular metabolism and inhibit mitosis. Its mechanism of action is likely due to incorporation of thiopurine analogues into the DNA structure, causing chain termination and cytotoxicity.
","Renal Homotransplantation: The dose of Azathioprine required to prevent rejection and minimize toxicity will vary with individual patients; this necessitates careful management. The initial dose is usually 3 to 5 mg/kg daily, beginning at the time of transplant. Azathioprine is usually given as a single daily dose on the day of, and in a minority of cases 1 to 3 days before, transplantation. Dose reduction to maintenance levels of 1 to 3 mg/kg daily is usually possible. The dose of Azathioprine should not be increased to toxic levels because of threatened rejection. Discontinuation may be necessary for severe hematologic or other toxicity, even if rejection of the homograft may be a consequence of drug withdrawal.
Rheumatoid Arthritis: Azathioprine is usually given on a daily basis. The initial dose should be approximately 1.0 mg/kg (50 to 100 mg) given as a single dose or on a twice-daily schedule. The dose may be increased, beginning at 6 to 8 weeks and thereafter by steps at 4-week intervals, if there are no serious toxicities and if initial response is unsatisfactory. Dose increments should be 0.5 mg/kg daily, up to a maximum dose of 2.5 mg/kg per day. Therapeutic response occurs after several weeks of treatment, usually 6 to 8; an adequate trial should be a minimum of 12 weeks. Patients not improved after 12 weeks can be considered refractory. Azathioprine may be continued long-term in patients with clinical response, but patients should be monitored carefully, and gradual dosage reduction should be attempted to reduce risk of toxicities.
Maintenance therapy should be at the lowest effective dose, and the dose given can be lowered decrementally with changes of 0.5 mg/kg or approximately 25 mg daily every 4 weeks while other therapy is kept constant. The optimum duration of maintenance Azathioprine has not been determined. Azathioprine can be discontinued abruptly, but delayed effects are possible.
",,"Metabolism inhibited by allopurinol. Reduces the neuromuscular blockade of curare, tubocurarine but potentiates that of succinylcholine.
","Azathioprine should not be used for treating rheumatoid arthritis in pregnant women.Patients with rheumatoid arthritis previously treated with alkylating agents (cyclophosphamide, chlorambucil, melphalan, or others) may have a prohibitive risk of malignancy if treated with Azathioprine
","Opportunistic infections especially in transplant patients receiving concomitant other immunosuppressants. Bone marrow depression, leucopenia, thrombocytopenia, nausea. Uncommonly, anaemia, hypersensitivity reactions, cholestasis, pancreatitis.
","Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk
","Monitor FBC wkly during 1st 8 wk of therapy especially with high dose or severe renal/hepatic impairment. Inherited deficiency of thiopurine methyltransferase enzyme. Avoid excessive sun/UV exposure.
","Use In Renal Dysfunction: Relatively oliguric patients, especially those with tubular necrosis in the immediate postcadaveric transplant period, may have delayed clearance of Azathioprine or its metabolites, may be particularly sensitive to this drug, and are usually given lower doses. Procedures for proper handling and disposal of this immunosuppressive antimetabolite drug should be considered. Several guidelines on this subject have been published.25-31 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
",,,,"Azathioprine should be stored at 15 to 25° C in a dry place and protected from light.
",11
+1383,Axitinib,axitinib-1383,https://medex.com.bd/attachments/7S4H3CX1AUdDQaMzl0njUJMzpjfSjI/axitinib-prescribing-information,Targeted Cancer Therapy,Renal cell carcinoma,"Axitinib is indicated for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy.
","Targeted Cancer Therapy
","Axitinib has been shown to inhibit receptor tyrosine kinases including vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2, and VEGFR-3 at therapeutic plasma concentrations. These receptors are implicated in pathologic angiogenesis, tumor growth, and cancer progression. VEGF-mediated endothelial cell proliferation and survival were inhibited by axitinib in vitro and in mouse models. Axitinib was shown to inhibit tumor growth and phosphorylation of VEGFR-2 in tumor xenograft mouse models.
","Recommended Dosing: The recommended starting oral dose of Axitinib is 5 mg twice daily. Administer Axitinib doses approximately 12 hours apart with or without food. Axitinib should be swallowed whole with a glass of water.
If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time.
Dose Modification Guidelines: Dose increase or reduction is recommended based on individual safety and tolerability.
Over the course of treatment, patients who tolerate Axitinib for at least two consecutive weeks with no adverse reactions > Grade 2 (according to the Common Toxicity Criteria for Adverse Events), are normotensive, and are not receiving anti-hypertension medication, may have their dose increased. When a dose increase from 5 mg twice daily is recommended, the Axitinib dose may be increased to 7 mg twice daily, and further to 10 mg twice daily using the same criteria.
Over the course of treatment, management of some adverse drug reactions may require temporary interruption or permanent discontinuation and/or dose reduction of Axitinib therapy. If dose reduction from 5 mg twice daily is required, the recommended dose is 3 mg twice daily. If additional dose reduction is required, the recommended dose is 2 mg twice daily.
",,"In vitro data indicate that axitinib is metabolized primarily by CYP3A4/5 and, to a lesser extent, CYP1A2, CYP2C19, and uridine diphosphate-glucuronosyltransferase (UGT) 1A1.
CYP3A4/5 Inhibitors: Co-administration of ketoconazole, a strong inhibitor of CYP3A4/5, increased the plasma exposure of axitinib in healthy volunteers. Co-administration of Axitinib with strong CYP3A4/5 inhibitors should be avoided. Grapefruit or grapefruit juice may also increase axitinib plasma concentrations and should be avoided. Selection of concomitant medication with no or minimal CYP3A4/5 inhibition potential is recommended. If a strong CYP3A4/5 inhibitor must be co-administered, the Axitinib dose should be reduced
CYP3A4/5 Inducers: Co-administration of rifampin, a strong inducer of CYP3A4/5, reduced the plasma exposure of axitinib in healthy volunteers. Co-administration of Axitinib with strong CYP3A4/5 inducers (e.g., rifampin, dexamethasone, phenytoin, carbamazepine, rifabutin, rifapentin, phenobarbital, and St. John's wort) should be avoided. Selection of concomitant medication with no or minimal CYP3A4/5 induction potential is recommended. Moderate CYP3A4/5 inducers (e.g., bosentan, efavirenz, etravirine, modafinil, and nafcillin) may also reduce the plasma exposure of axitinib and should be avoided if possible.
","None
","Selected adverse reactions (all grades) that were reported in < 10% of patients treated with Axitinib included dizziness (9%), upper abdominal pain (8%), myalgia (7%), dehydration (6%), epistaxis (6%), anemia (4%), hemorrhoids (4%), hematuria (3%), tinnitus (3%), lipase increased (3%), glossodynia (3%), pulmonary embolism (2%), rectal hemorrhage (2%), hemoptysis (2%), deep vein thrombosis (1%), retinal-veinocclusion/thrombosis (1%), polycythemia (1%), and transient ischemic attack (1%).
","Pregnancy Category D. Axitinib can cause fetal harm when administered to a pregnant woman based on its mechanism of action. There are no adequate and well-controlled studies in pregnant women using Axitinib. In developmental toxicity studies in mice, axitinib was teratogenic, embryotoxic and fetotoxic at maternal exposures that were lower than human exposures at the recommended clinical dose.
Women of childbearing potential should be advised to avoid becoming pregnant while receiving Axitinib. If this drug is used during pregnancy, or if a patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus
Nursing Mothers: It is not known whether axitinib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Axitinib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","Patient with HTN, cardiac disease, history of or risk for thrombosis. Patients taking strong CYP3A4 inhibitors. Withhold treatment at least 24 hr prior to scheduled surgery. Moderate hepatic impairment (Child-Pugh Class B). Pregnancy.
","Hepatic Impairment: The systemic exposure to axitinib was higher in subjects with moderate hepatic impairment (Child-Pugh class B) compared to subjects with normal hepatic function. A dose decrease is recommended when administering Axitinib to patients with moderate hepatic impairment (Child-Pugh class B). Axitinib has not been studied in patients with severe hepatic impairment (Child-Pugh class C)
Renal Impairment: No dedicated renal impairment trial for axitinib has been conducted. Based on the population pharmacokinetic analyses, no significant difference in axitinib clearance was observed in patients with pre-existing mild to severe renal impairment (15 mL/min ≤ ClCr < 89 mL/min). No starting dose adjustment is needed for patients with pre-existing mild to severe renal impairment. Caution should be used in patients with end-stage renal disease (ClCr< 15 mL/min).
Pediatric Use: The safety and efficacy of axitinib in pediatric patients have not been studied.
Geriatric Use: No dosage adjustment is required in elderly patients
","There is no specific treatment for Axitinib overdose.
In a controlled clinical study with Axitinib for the treatment of patients with RCC, 1 patient inadvertently received a dose of 20 mg twice daily for 4 days and experienced dizziness (Grade 1).
In a clinical dose finding study with Axitinib, subjects who received starting doses of 10 mg twice daily or 20 mg twice daily experienced adverse reactions which included hypertension, seizures associated with hypertension, and fatal hemoptysis.
In cases of suspected overdose, Axitinib should be withheld and supportive care instituted.
",,,"Store at 20°C to 25°C
",12
+1396,Avanafil,avanafil-1396,https://medex.com.bd/attachments/hJUn25VrJ3qNvWTD076vy9p8r4P4Ko/avanafil-prescribing-information,Drugs for Erectile Dysfunction,Erectile dysfunction,"Avanafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction
","Drugs for Erectile Dysfunction
","Avanafil is a selective phosphodiesterase 5 (PDE5) enzyme inhibitor used for the treatment of erectile dysfunction caused by diabetes, age induced oxidative stress or other complications. Avanafil inhibits the cGMP specific phosphodiesterase type 5 (PDE5) which is responsible for degradation of cGMP in the corpus cavernosum located around the penis. Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle. This response is mediated by the release of nitric oxide (NO) from nerve terminals and endothelial cells, which stimulates the synthesis of cGMP in smooth muscle cells. Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum. The inhibition of phosphodiesterase type 5 (PDE5) by avanafil enhances erectile function by increasing the amount of cGMP.
","For most patients, the starting dose is 100 mg taken approximately 30 minutes before sexual activity, on an as needed basis. Avanafil may be taken with or without food. Take Avanafil no more than once a day
The dose may be increased to 200 mg or decreased to 50 mg based on efficacy and/or tolerability. Use the lowest dose that provides benefit
Do not use Avanafil with strong CYP3A4 inhibitors. If taking a moderate CYP3A4 inhibitor, the dose should be no more than 50 mg in a 24-hour period. In patients on stable alpha-blocker therapy, the recommended starting dose of Avanafil is 50 mg
",,"Avanafil can potentiate the hypotensive effect of nitrates, alphablockers, antihypertensives, and alcohol. CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, erythromycin) increase Avanafil exposure
","Administration of Avanafil to patients using any form of organic nitrate is contraindicated. Hypersensitivity to any component of the Avanafil tablet
","Most common adverse reactions (greater than or equal to 2%) include headache, flushing, nasal congestion, nasopharyngitis, and back pain
","Pregnancy Category C. Avanafil is not indicated for use in women. There are no adequate and well-controlled studies of Avanafil in pregnant women.
","Patients should not use Avanafil if sexual activity is inadvisable due to cardiovascular status or any other reason
Use of Avanafil with alpha-blockers, other antihypertensives, or substantial amounts of alcohol (greater than 3 units) may lead to hypotension
Patients should seek emergency treatment if an erection lasts greater than 4 hours
Patients should stop Avanafil and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of Non Arteritic Ischemic Optic Neuropathy (NAION). Discuss with patients the increased risk of NAION in patients with a history of NAION
Patients should stop taking Avanafil and seek prompt medical attention in the event of sudden decrease or loss of hearing
","Pediatric Use: STENDRA is not indicated for use in pediatric patients. Safety and efficacy in patients below the age of 18 years has not been established.
Geriatric Use: Of the total number of subjects in clinical studies of avanafil, approximately 23% were 65 and over. No overall differences in efficacy and safety were observed between subjects over 65 years of age compared to younger subjects; therefore no dose adjustment is warranted based on age alone. However, a greater sensitivity to medication in some older individuals should be considered
Renal & hepatic impairment patients: Do not use in patients with severe renal & hepatic impairment
","Single doses up to 800 mg have been given to healthy subjects, and multiple doses up to 300 mg have been given to patients. In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance because avanafil is highly bound to plasma proteins and is not significantly eliminated in the urine.
",,,"Store at 20-25°C
",12
+94,Atropine Sulfate,atropine-sulfate-94,https://medex.com.bd/attachments/IwTrZ0JHYQC4Hmkd4kvm7ge85ww0wQ/atropine-sulfate-prescribing-information-prescribing-information,Mydriatic and Cycloplegic agents,Organophosphorous poisoning,"Atropine is indicated for Non ulcer dyspepsia, Irritable bowel syndrome, Diverticular disease, Bradycardia, Organophosphorus poisoning, Premedication in anesthesia, Poisoning or overdosage with compound having muscarinic actions, Ophthalmic Inflammatory eye disorders, Eye refraction.
","Anticholinergics (antimuscarinics)/ Anti-spasmodics, Mydriatic and Cycloplegic agents
","Atropine binds to and inhibit muscarinic acetylcholine receptors, producing a wide range of anticholinergic effects. Atropine is an anticholinergic agent which competitively blocks the muscarinic receptors in peripheral tissues such as the heart, intestines, bronchial muscles, iris and secretory glands. Some central stimulation may occur. Atropine abolishes bradycardia and reduces heart block due to vagal activity. Smooth muscles in the bronchi and gut are relaxed while glandular secretions are reduced. It also has mydriatic and cycloplegic effect.
","Adult:
+
+- IV: Bradycardia: 500 mcg every 3-5 mins. Total: 3 mg.
+- IV/IM: Organophosphorus poisoning: 2 mg every 10-30 mins until muscarinic effects disappear or atropine toxicity appears.
+- IM/SC: Premedication in anesthesia: 300-600 mcg 30-60 mins before anesthesia.
+- IV/IM/SC: Poisoning or overdosage with compound having muscarinic actions: 0.6-1 mg, repeat 2 hrly.
+- Ophthalmic: Inflammatory eye disorders: As 0.5-1% solution: 1-2 drops 4 times/day.
+- Ophthalmic: refraction: 1% solution 1 drop twice daily for 1-2 days before procedure.
+- Oral: Non ulcer dyspepsia, Irritable bowel syndrome, Diverticular disease: 0.6-1.2 mg as a single dose at bedtime.
+
+Usual Pediatric Dose for Anesthesia:
+
+- 7 to 16 pounds: 0.1 mg, IV, IM, or subcutaneously
+- 17 to 24 pounds: 0.15 mg, IV, IM, or subcutaneously
+- 24 to 40 pounds: 0.2 mg, IV, IM, or subcutaneously
+- 40 to 65 pounds: 0.3 mg, IV, IM, or subcutaneously
+- 65 to 90 pounds: 0.4 mg, IV, IM, or subcutaneously
+- Over 90 pounds: 0.4 to 0.6 mg, IV, IM, or subcutaneously
+
",,"Additive anticholinergic effects with quinidine, antidepressants and some antihistamines.
","Glaucoma, chronic respiratory disease, sick sinus syndrome, thyrotoxicosis, cardiac failure, pyloric stenosis, prostatic hypertrophy.
","Injection: Dry mouth, dysphagia, constipation, flushing and dryness of skin, tachycardia, palpitations, arrhythmias, mydriasis, photophobia, cycloplegia, raised intraocular pressure. Toxic doses cause tachycardia, hyperpyrexia, restlessness, confusion, excitement, hallucinations, delirium and may progress to circulatory failure and resp depression.
Eye drops or ointment: Systemic toxicity esp in children, on prolonged use may lead to irritation, hyperaemia, oedema and conjunctivitis. Increased intraocular pressure.
","Pregnancy Category C. Animal reproduction studies have not been conducted with atropine. It also is not known whether atropine can cause fetal harm when given to a pregnant woman or can affect reproduction capacity. Atropine should be given to a pregnant woman only if clearly needed.
","Reflux oesophagitis; elderly; infants and children; Pregnancy.
",,"May cause hyperthermia, hypertension, increased respiratory rate, nausea and vomiting. May also lead to CNS stimulation. Severe intoxication may lead to CNS depression, coma, respiratory failure and death.
",,,"Store atropine at room temperature between 20 to 25° C. Store away from heat, moisture, and light. Keep atropine out of the reach of children.
",11
+93,Atracurium Besilate,atracurium-besilate-93,https://medex.com.bd/attachments/C2ysQKP2cI6QsoXgiloprdCEwS1oRs/atracurium-besilate-prescribing-information,Non depolarizing muscle relaxants,General anaesthesia,"Atracurium is indicated for endotracheal intubation, facilitate mechanical ventilation in intensive care, muscle relaxant in general anaesthesia.
","Non depolarizing muscle relaxants
","Atracurium antagonizes the neurotransmitter action of acetylcholine by binding competitively with cholinergic receptor sites on the motor end-plate. This antagonism is inhibited, and neuromuscular block reversed, by acetylcholinesterase inhibitors such as neostigmine, edrophonium, and pyridostigmine.
","Adult and Child (>1 month): Initially, 300-600 mcg/kg as bolus IV, with subsequent doses of 100-200 mcg/kg by IV every 15-25 min or 5-10 mcg/kg/min by infusion in prolonged procedures. Higher infusion rate may be used in patients undergoing controlled ventilation in intensive care.
",,"Enhanced neuromuscular blocking effect w/ general anaesth (e.g. enflurane, isoflurane, halothane), certain antibiotics (e.g. aminoglycosides, polymyxins), lithium, Mg salts, procainamide, quinidine.
","Atracurium is contraindicated in patients known to be hypersensitive to atracurium, cisatracurium or benzenesulfonic acid. In common with all the other neuromuscular blocking agents, atracurium besilate paralyses the respiratory muscles as well as other skeletal muscles but has no effect on consciousness.
","Skin flush, erythema, pruritus, urticaria, wheezing, increased bronchial secretions, bronchospasm, cyanosis, angioedema, CV effects (e.g. bradycardia); wheals and erythema at inj site. Potentially Fatal: Anaphylaxis.
","Pregnancy Category C: Teratogenic Effects. Atracurium besylate has been shown to be potentially teratogenic in rabbits when given in doses up to approximately one-half the human dose. There are no adequate and well-controlled studies in pregnant women. Atracurium should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
","Patient with CV disease, burn injury, asthma; conditions which may antagonise neuromuscular blockade (e.g. resp alkalosis, hypercalcaemia, demyelinating lesions, peripheral neuropathies, denervation, muscle trauma); conditions which may potentiate neuromuscular blockade (e.g. electrolyte abnormalities, neuromuscular diseases, metabolic acidosis, resp acidosis, Eaton-Lambert syndrome, myasthenia gravis). Pregnancy and lactation.
",,"Stimulation of histamine release, CV effects especiall hypotension
",,,"Store between 2-8° C. Do not freeze.
",11
+1819,Atosiban Acetate,atosiban-acetate-1819,https://medex.com.bd/attachments/STdVQ3c6Be40Ev14dqLnUnVHGkEIkj/atosiban-acetate-prescribing-information,Other preparations,Delay imminent pre-term birth,"Atosiban is indicated to delay imminent pre-term birth in pregnant adult women with:
+
+- regular uterine contractions of at least 30 seconds duration at a rate of ≥4 per 30 minutes
+- a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of ≥50%
+- a gestational age from 24 until 33 completed weeks
+- a normal fetal heart rate
+
","Other preparations
","It binds to membrane bound oxytocin receptors on the myometrium and prevents oxytocin-stimulated increases in inositol triphosphate production. This ultimately prevents release of stored calcium from the sarcoplasmic reticulum and subsequent opening of voltage gated calcium channels. This shutdown of cytosolic calcium increase prevents contractions of the uterine muscle, reducing the frequency of contractions and inducing uterine quiescence.
Atosiban has more recently been found to act as a biased ligand at oxytocin receptors. It acts as an antagonist of Gq coupling, explaining the inhibition of the inositol triphosphate pathway thought to be responsible for the effect on uterine contraction, but acts as an agonist of Gi coupling. This agonism produces a pro-inflammatory effect in the human amnion, activating pro-inflammatory signal tranducer NF-κB. It is thought that this reduces atosiban's effectiveness compared to agents which do not produce inflammation as inflammatory mediators are known to play a role in the induction of labour.
","Atosiban is administered intravenously in three successive stages: an initial bolus dose (6.75 mg), performed with Atosiban 6.75 mg/0.9 ml solution for injection, immediately followed by a continuous high dose infusion (loading infusion 300 micrograms/min) of Atosiban 37.5 mg/5 ml concentrate for solution for infusion during three hours, followed by a lower dose of Atosiban 37.5 mg/5 ml concentrate for solution for infusion (subsequent infusion 100 micrograms/min) up to 45 hours. The duration of the treatment should not exceed 48 hours. The total dose given during a full course of Atosiban therapy should preferably not exceed 330.75 mg of atosiban.
",,"It is unlikely that atosiban is involved in cytochrome P450 mediated drug-drug interactions as in vitro investigations have shown that atosiban is not a substrate for the cytochrome P450 system, and does not inhibit the drug metabolising cytochrome P450 enzymes. Interaction studies have been performed with labetalol and betamethasone in healthy, female volunteers. No clinically relevant interaction was found between atosiban and bethamethasone or labetalol.
","Atosiban must not be used in the following conditions:
+
+- Gestational age below 24 or over 33 completed weeks
+- Premature rupture of the membranes >30 weeks of gestation
+- Abnormal foetal heart rate
+- Antepartum uterine haemorrhage requiring immediate delivery
+- Eclampsia and severe pre-eclampsia requiring delivery
+- Intrauterine foetal death
+- Suspected intrauterine infection
+- Placenta praevia
+- Abruptio placenta
+- Any other conditions of the mother or foetus, in which continuation of pregnancy is hazardous
+
","Very common (affects more than 1 in 10 people): feeling sick (nausea).
Common (affects less than 1 in 10 people): headache, feeling dizzy, hot flushes, being sick (vomiting), fast heartbeat, Low blood pressure. Signs may include feeling dizzy or light-headed, A reaction at the site where the injection was given, high blood sugar.
Uncommon (affects less than 1 in 100 people): high temperature (fever), difficulty sleeping (insomnia), itching, rash.
","If you are pregnant and breast-feeding an earlier child, you should stop breast-feeding while you are given
Atosiban.
","
+- When Atosiban is used in patients in whom premature rupture of membranes cannot be excluded, the benefits of delaying delivery should be balanced against the potential risk of chorioamnionitis.
+- There is no experience with Atosiban treatment in patients with impaired function of the liver or kidneys. Renal impairment is not likely to warrant a dose adjustment, since only a small extent of Atosiban is excreted in the urine. In patients with impaired hepatic function, Atosiban should be used with caution
+- There is only limited clinical experience in the use of Atosiban in multiple pregnancies or the gestational age group between 24 and 27 weeks, because of the small number of patients treated. The benefit of Atosiban in these subgroups is therefore uncertain.
+- Re-treatment with Atosiban is possible, but there is only limited clinical experience available with multiple re-treatments, up to 3 re-treatments.
+- In case of intrauterine growth retardation, the decision to continue or reinitiate the administration of Atosiban depends on the assessment of fetal maturity.
+- Monitoring of uterine contractions and fetal heart rate during administration of Atosiban and in case of persistent uterine contractions should be considered.
+- As an antagonist of oxytocin, Atosiban may theoretically facilitate uterine relaxation and postpartum bleeding therefore blood loss after delivery should be monitored. However, inadequate uterus contraction postpartum was not observed during the clinical trials.
+- Multiple pregnancy and medicinal products with tocolytic activity like calcium channel blockers and beta- mimetics are known to be associated with increased risk of pulmonary oedema. Therefore, Atosiban should be used with caution in case of multiple pregnancy and/or concomitant administration of other medicinal products with tocolytic activity
+
",,,,,"Store in a refrigerator (2°C-8°C). Keep away from light & moisture. Keep out of the reach of children.
",10
+92,Atorvastatin Calcium,atorvastatin-calcium-92,https://medex.com.bd/attachments/Pa9l1Iq39HcoHYqmEIcJU1mwd2TWMs/atorvastatin-calcium-prescribing-information,Other Anti-anginal & Anti-ischaemic drugs,Reducing cholesterol levels,"Atorvastatin is indicated as an adjunct to diet to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B (Apo-B) and triglycerides levels in following diseases when response to diet and other non-pharmacological measures is inadequate.
+
+- To reduce total cholesterol and LDL cholesterol in patients with heterozygous and homozygous familial hypercholesterolaemia.
... Read more
Atorvastatin is indicated as an adjunct to diet to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B (Apo-B) and triglycerides levels in following diseases when response to diet and other non-pharmacological measures is inadequate.
+
+- To reduce total cholesterol and LDL cholesterol in patients with heterozygous and homozygous familial hypercholesterolaemia.
+- To reduce elevated cholesterol and triglycerides in patient with mixed dyslipidemia (Fredrickson Type Ia and Ib).
+- For the treatment of patients with elevated serum triglyceride levels in hypertriglyceridaemia (Fredrickson Type IV).
+- For the treatment of patients with dysbetalipoproteinaemia (Fredrickson Type III).
+- To reduce cardiac ischaemic events in patients with asymptomatic or mild to moderate symptomatic coronary artery disease with elevated LDL-cholesterol level.
+- To reduce total and LDL-cholesterol concentrations patients with hypercholesterolemia associated with or exacerbated by diabetes mellitus or renal transplantation.
+
","Other Anti-anginal & Anti-ischaemic drugs, Statins
","Atorvastatin is a selective inhibitor of HMG-CoA reductase. This enzyme is the rate-limiting enzyme responsible for the conversion of HMG-CoA to mevalonate, a precursor of sterols, including cholesterol. Atorvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.
","Primary hypercholesterolaemia and combined hyperlipidaemia-
+
+- Adults: Usually 10 mg once daily; if necessary, may be increased at intervals of at least 4 weeks to max. 80 mg once daily.
+- Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 20 mg once daily.
+
+Familial hypercholesterolaemia-
+
+- Adults: Initially 10 mg daily, increased at intervals of at least 4 weeks to 40 mg once daily; if necessary, further increased to max. 80 mg once daily (or 40 mg once daily combined with anion-exchange resin in heterozygous familial hypercholesterolaemia).
+- Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 80 mg once daily.
+
+Prevention of cardiovascular events-
+
+- Adults: Initially 10 mg once daily adjusted according to response.
+
",,"The risk of myopathy during treatment with Atorvastatin is increased with concurrent administration of cyclosporin, fibric acid derivatives, erythromycin, azole antifungals and niacin. No clinically significant interactions were seen when Atorvastatin was administered with antihypertensives or hypoglycemic agents. Patients should be closely monitored if Atorvastatin is added to digoxin, erythromycin, oral contraceptives, colestipol, antacid and warfarin.
","Atorvastatin should not be used in patient with hypersensitivity to any component of this medication. Atorvastatin is contraindicated in active liver disease or unexplained persistent elevations of serum transaminases. It is also contraindicated in patient with history of serious adverse reaction to prior administration of HMG-CoA reductase inhibitors.
","Atorvastatin is generally well-tolerated. The most frequent side effects related to Atorvastatin are constipation, flatulence, dyspepsia, abdominal pain. Other side effects includes infection, headache, back pain, rash, asthenia, arthralgia, myalgia.
","Pregnancy: Atorvastatin is contraindicated during pregnancy. Safety in pregnant women has not been established. No controlled clinical trials with atorvastatin have been conducted in pregnant women. Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received. Animal studies have shown toxicity to reproduction. Maternal treatment with atorvastatin may reduce the fetal levels of mevalonate which is a precursor of cholesterol biosynthesis. Atorvastatin should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant. Treatment with atorvastatin should be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant
Lactation: It is not known whether atorvastatin or its metabolites are excreted in human milk. In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk. Because of the potential for serious adverse reactions, women taking atorvastatin should not breastfeed their infants. Atorvastatin is contraindicated during breastfeeding.
","Liver effects: Liver function tests should be performed before the initiation of treatment and periodically thereafter. Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol or have a history of liver disease. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.
","Hepatic impairment: Atorvastatin should be used with caution in patients with hepatic impairment.
Pediatric use: For patients aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day with titration up to 20 mg per day. Atorvastatin is not indicated in the treatment of patients below the age of 10 years.
","Specific treatment is not available for atorvastatin overdose. The patient should be treated symptomatically and supportive measures instituted, as required. Liver function tests should be performed and serum CK levels should be monitored. Due to extensive atorvastatin binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin clearance.
",,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",12
+2049,Atorvastatin + Ezetimibe,atorvastatin-ezetimibe-2049,https://medex.com.bd/attachments/Z9UyuJHtDPKmvrhrYUNAydbz6WsPea/atorvastatin-ezetimibe-prescribing-information,Other lipid regulating drugs,,"Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted ... Read more
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.
Primary Hyperlipidemia: This tablet is indicated for the reduction of elevated total cholesterol (total-C), low density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia.
Homozygous Familial Hypercholesterolemia (HoFH): This tablet is indicated for the reduction of elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
","Other lipid regulating drugs
","Atorvastatin: In animal models, atorvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and by increasing the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL; atorvastatin also reduces LDL production and the number of LDL particles.
Ezetimibe: Ezetimibe reduces blood cholesterol by inhibiting the absorption of cholesterol by the small intestine. The molecular target of ezetimibe has been shown to be the sterol transporter, Niemann-Pick C1-Like 1 (NPC1L1), which is involved in the intestinal uptake of cholesterol and phytosterols. In a 2-week clinical study in 18 hypercholesterolemic patients, ezetimibe inhibited intestinal cholesterol absorption by 54%, compared with placebo. Ezetimibe had no clinically meaningful effect on the plasma concentrations of the fat-soluble vitamins A, D, and E and did not impair adrenocortical steroid hormone production. Ezetimibe does not inhibit cholesterol synthesis in the liver or increase bile acid excretion. Ezetimibe localizes at the brush border of the small intestine and inhibits the absorption of cholesterol, leading to a decrease in the delivery of intestinal cholesterol to the liver. This causes a reduction of hepatic cholesterol stores and an increase in clearance of cholesterol from the blood; this distinct mechanism is complementary to that of statins.
","The dosage range is 10/10 mg/day through 80/10 mg/day. Recommended starting dose is 10/10 mg/day or 20/10 mg/day. Recommended starting dose is 40/10 mg/day for patients requiring a greater than 55% reduction in LDL-C. Dosing of this tablet should occur either greater than or equal to 2 hours before or greater than or equal to 4 hours after administration of a bile acid sequestrant.
",,"
+- Cyclosporine, HIV protease inhibitors (tipranavir plus ritonavir), hepatitis C protease inhibitor (telaprevir), gemfibrozil: Avoid this tablet
+- HIV protease inhibitor (lopinavir plus ritonavir): Use with caution and lowest dose necessary.
+- Clarithromycin, itraconazole, HIV protease inhibitors (saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir): Do not exceed 10/20 mg this tablet daily.
+- HIV protease inhibitor (nelfinavir), hepatitis C protease inhibitor (boceprevir): Do not exceed 10/40 mg this tablet daily.
+- Other lipid-lowering medications: Use with fenofibrates or lipid-modifying doses (≥1 g/day) of niacin increases the risk of adverse skeletal muscle effects. Caution should be used when prescribing with this tablet.
+- Fenofibrates: Combination increases exposure of ezetimibe. If cholelithiasis is suspected in a patient receiving ezetimibe and a fenofibrate, gallbladder studies are indicated and alternative lipid- lowering therapy should be considered.
+- Cholestyramine: Combination decreases exposure of ezetimibe.
+- Digoxin: Patients should be monitored appropriately.
+- Oral contraceptives: Values for norethindrone and ethinyl estradiol may be increased.
+- Rifampin should be simultaneously coadministered with this tablet.
+
","
+- Active liver disease or unexplained persistent elevations of hepatic transaminase levels.
+- Hypersensitivity to any component of this tablet.
+- Women who are pregnant or may become pregnant.
+- Nursing mothers.
+
",,"Pregnancy Category X. This tablet is contraindicated in women who are or may become pregnant. Serum cholesterol and triglycerides increase during normal pregnancy. Lipid-lowering drugs offer no benefit during pregnancy, because cholesterol and cholesterol derivatives are needed for normal fetal development. Atherosclerosis is a chronic process, and discontinuation of lipid-lowering drugs during pregnancy should have little impact on long-term outcomes of primary hypercholesterolemia therapy. It is not known whether atorvastatin is excreted in human milk, but a small amount of another drug in this class does pass into breast milk.
","Patients should be advised to report promptly any unexplained and/or persistent muscle pain, tenderness, or weakness. This tablet should be discontinued immediately if myopathy is diagnosed or suspected.
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with higher doses and concomitant use of certain CYP3A4 inhibitors, fibric acid derivatives, and cyclosporine. Predisposing factors include advanced age (>65), uncontrolled hypothyroidism, and renal impairment. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported.
Liver enzyme abnormalities: Persistent elevations in hepatic transaminase can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+91,Atomoxetine Hydrochloride,atomoxetine-hydrochloride-91,https://medex.com.bd/attachments/Q1tOEnWlKheL7ZQXAXiFHuulR4eC9H/atomoxetine-hydrochloride-prescribing-information,CNS stimulant drugs,Hyperactivity disorders,"Attention deficit hyperactivity disorder (ADHD).
","CNS stimulant drugs
","The precise mechanism by which Atomoxetine produces its therapeutic effects in Attention Deficit Hyperactivity Disorder (ADHD) is unknown. But, it is thought to be related to selective inhibition of the pre-synaptic nor-epinephrine transporter. Atomoxetine is well-absorbed after oral administration and is minimally affected by food. It is eliminated primarily by oxidative metabolism through the cytochrome P450 2D6 (CYP2D6) enzymatic pathway.
","Adult & adolescents-
>70 kg:
+
+- Initially: 40 mg/day for at least 7 days.
+- Maintenance: 80 mg/day.
+- Max: 100 mg/day.
+
+Children & adolescents-
Up to 70 kg:
+
+- Initially: 0.5 mg/kg/day for at least 7 days.
+- Maintenance: 1.2 mg/kg/day.
+- Max: 1.8 mg/kg/day.
+
",,"Albuterol, CYP2D6 inhibitors & antihypertensive agents interact with Atomoxetine.
","
+- Hypersensitivity to Atomoxetine
+- Concomitant use with Monoamine oxidase inhibitors (MAOIs).
+- Narrow-angle glaucoma.
+- Severe cardiovascular or cerebrovascular disorders.
+- History of pheochromocytoma.
+
","Decreased appetite; headache; nausea; increased BP & heart rate; Insomnia; dry mouth in adults; Somnolence; abdominal pain; vomiting in children.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
","Atomoxetine should be used with caution in patients with a history of seizures. Atomoxetine can affect heart rate and blood pressure. It is recommended that the heart rate and blood pressure be measured before treatment is started and periodically during treatment to detect possible clinically important increases. Most patients taking Atomoxetine experience a modest increase in heart rate
","Pediatric use: The pharmacokinetics of Atomoxetine have not been evaluated in children under 6 years of age.
","The most commonly reported gastrointestinal symptoms including somnolence, dizziness, tremor, and abnormal behaviour. Hyperactivity and agitation have also been reported. Signs and symptoms consistent with mild to moderate sympatheticnervous system activation (e.g. tachycardia, blood pressure increased, mydriasis, dry mouth) were also observed. Most events were mild to moderate. In some cases of overdose involving Atomoxetine, seizures and very rarely QT prolongation have been reported. There is limited clinical trial experience with Atomoxetine overdose. No fatal overdoses occurred in clinical trials.
",,,"Store in a cool and dry place, protected from light and moisture.
",12
+1500,Atezolizumab,atezolizumab-1500,,"Vaccines, Anti-sera & Immunoglobulin",Urothelial bladder carcinoma,"Atezolizumab is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC):
+
+- After prior chemotherapy, or
+- Who are considered cisplatin ineligibleand whose tumours have a PD-L1 expression ≥ 5%, or
+- Who are not eligible for any platinum-containing chemotherapy regardless of level of tumor PD-L1 expression.
... Read more
Atezolizumab is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC):
+
+- After prior chemotherapy, or
+- Who are considered cisplatin ineligibleand whose tumours have a PD-L1 expression ≥ 5%, or
+- Who are not eligible for any platinum-containing chemotherapy regardless of level of tumor PD-L1 expression.
+
+Atezolizumab is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer NSCLC after prior chemotherapy.
","Anti neoplastic preparations, Vaccines, Anti-sera & Immunoglobulin
","Binding of PD-L1 to the PD-1 and B7.1 receptors found on T cells suppresses cytotoxic T-cell activity through the inhibition of T-cell proliferation and cytokine production. PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells, and can contribute to the inhibition of the antitumor immune response in the microenvironment.
Atezolizumab is an Fc-engineered humanized immunoglobulin G1 (IgG1) monoclonal antibody that directly binds to PD-L1 and blocks interactions with the PD-1 and B7.1 receptors, releasing PD-L1 / PD-1 pathway-mediated inhibition of the immune response, including reactivating the antitumor immune response. Atezolizumab leaves the PD-L2/PD-1 interaction intact. In syngeneic mouse tumor models, blocking PD-L1 activity resulted in decreased tumor growth
","General: Atezolizumab must be administered as an intravenousinfusion under the supervision of a qualified healthcare professional. Do not administer as an IV push or bolus. Substitution by any other biological medicinal product requires the consent of the prescribing physician. The initial dose of Atezolizumab must be administered over 60 minutes. If the first infusion is tolerated all subsequent infusions may be administered over 30 minutes. The recommended dose of Atezolizumab is either:
+
+- 1200 mg administered by IV infusion every 3 weeks or
+- 1680 mg administered by IV infusion every 4 weeks.
+
+
1L cisplatin-ineligible mUC: Patients should be selected for treatment based on the tumor expression of PD-L1 confirmed by a validated test
",,,"Atezolizumab is contraindicated in patients with a known hypersensitivity to atezolizumab or any of the excipients.
",,"There are no clinical studies of Atezolizumab in pregnant women. Atezolizumab is not recommended during pregnancy unless the potential benefit for the mother outweighs the potential risk to the fetus
It is not known whether Atezolizumab is excreted in human breast milk. No studies have been conducted to assess the impact of Atezolizumab on milk production or its presence in breast milk.Asthe potential for harm to the nursing infant is unknown,a decision must be madeto either discontinue breast-feeding ordiscontinue Atezolizumabtherapy.
","Immune-related pneumonitis: Cases of pneumonitis, including fatal cases, have been observed in clinical trials with Atezolizumab. Patients should be monitored for signs and symptoms of pneumonitis.
Immune-related hepatitis: Cases of hepatitis, some leading to fatal outcomes, have been observed in clinical trials with Atezolizumab. Patients should be monitored for signs and symptoms of hepatitis. Monitor aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin prior to and periodically during treatment with Atezolizumab. Consider appropriate management of patients with abnormal liver function tests (LFTs) at baseline.
Immune-related colitis: Cases of diarrhea or colitis have been observed in clinical trials with Atezolizumab. Patients should be monitored for signs and symptoms of colitis.
Immune-related endocrinopathies: Hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis, and type 1 diabetes mellitus, including diabetic ketoacidosis, have been observed in clinical trials with Atezolizumab. Patients should be monitored for clinical signs and symptoms of endocrinopathies. Monitor thyroid function prior to and periodically during treatment with Atezolizumab. Consider appropriate management of patients with abnormal thyroid function tests at baseline. Patients with abnormal thyroid function tests who are asymptomatic may receive Atezolizumab.
","Pediatric use: The safety and efficacy of Atezolizumab in children and adolescents below 18 years of age have not been established.
Geriatric use: Based on a population pharmacokinetic analysis, no dose adjustment of Atezolizumab is required in patients ≥ 65 years of age
Renal impairment: Based on a population pharmacokinetic analysis, no dose adjustment is required in patients with renal impairment
Hepatic impairment: Based on a population pharmacokinetic analysis, no dose adjustment is required for patients with mild hepatic impairment. There are no data in patients with moderate or severe hepatic impairment
","There is no information on overdose with Atezolizumab
",,,"Store at 2°C-8°C. Atezolizumab should be protected from light. Do not freeze. Do not shake.
",10
+89,Atenolol + Chlorthalidone,atenolol-chlorthalidone-89,https://medex.com.bd/attachments/19Tf1amXGrhraQ7sgPKLi2pPZwQ4lg/atenolol-chlorthalidone-prescribing-information,Combined antihypertensive preparations,Hypertension,"This combination is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions.
","Combined antihypertensive preparations
","Atenolol and chlorthalidone have been used singly and concomitantly for the treatment of hypertension. Studies have shown that there is no interference with bioavailability when these agents are given together in the single combination tablet. Therefore, this combination provides a convenient formulation for the concomitant administration of these two drugs.
Atenolol is a beta1-selective (cardioselective) beta-adrenergic receptor blocking agent that provides-
+
+- reduction in resting and exercise heart rates and cardiac output
+- reduction of systolic and diastolic blood pressure at rest and on exercise
+- reduction in reflex orthostatic tachycardia.
+
+Chlorthalidone is a monosulfonamyl diuretic with prolonged action and low toxicity. It produces diuresis with greatly increased excretion of sodium and chloride at distal convoluted tubule of the nephron.
","The initial dose is Atenolol 50 mg and Chlorthalidone 25 mg once a day. If an optimal response is not achieved, another antihypertensive agent may be added gradually beginning with 50 percent of the usual recommended starting dose to avoid an excessive fall in blood pressure. Atenolol is excreted via kidneys and therefore dosage should be adjusted in cases of severe impairment of renal function.
Use in elderly: Clinical studies of Atenolol & Chlorthalidone combination did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
",,"
+- This combination may potentiate the action of other antihypertensive agents used concominantly. Concominant use with catecholamine depletor (eg, reserpine) may cause hypotension and/or marked bradycardia
+- Calcium channel blockers, Amiodarone may have an additive effect when given with this combination.
+- Concomitant use of prostaglandin synthase inhibiting drugs, eg, indomethacin, may decrease the hypotensive effects of beta blockers.
+- Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
+
","Atenolol and Chlorthalidone combination is contraindicated in hypersensitivity to this product or to sulfonamide-derived drugs. It is also contraindicated in patients with sinus bradycardia, heart block greater than first degree, cardiogenic shock, overt cardiac failure and anuria.
","The adverse effects observed for this combination are essentially the same as those seen with the individual components. Atenolol: Bradycardia, Cold Extremities, Postural Hypotension, Leg Pain, Dizziness, Vertigo, Light Headedness, Tiredness, Fatigue, Lethargy, Drowsiness, Depression, Dreaming, Diarrhea, Nausea, Wheeziness, Dyspnea, Chlorthalidone Orthostatic hypotension, anorexia, gastric irritation, vomiting, cramping, constipation, vertigo, purpura, photosensitivity, rash, urticaria, hyperglycemia, glycosuria, hyperuricemia, muscle spasm, weakness, restlessness.
","Pregnancy Category D. Caution should be exercised when this drug is administered to a woman who is breastfeeding.
","This combination may aggravate peripheral arterial circulatory disorders. Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.
",,"No specific information is available with regard to overdosage of this combination in humans. Treatment should be symptomatic and supportive and directed to the removal of any unabsorbed drug by induced emesis, or administration of activated charcoal. Atenolol can be removed from the general circulation by hemodialysis. Further consideration should be given to dehydration, electrolyte imbalance and hypotension by established procedures.
",,,"Store in cool and dry place, protected from light.
",11
+88,Atenolol,atenolol-88,https://medex.com.bd/attachments/8CAStfEJ6ZLJr7oa8krzRGprb00sxP/atenolol-astrazeneca-prescribing-information,Beta-adrenoceptor blocking drugs,Tachycardia,"Atenolol is indicated-
+
+- In the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic.
+- For the long-term management of patients with angina pectoris.
+- In the management of hemodynamically stable patients with defnite or suspected acute myocardial infarction to reduce cardiovascular mortality.
+
","Beta-adrenoceptor blocking drugs, Beta-blockers
","The synthesis of atenolol resulted from attempts to produce a β-adrenoceptor antagonist that would competitively block β1 (cardiac) receptors but have no effect on β2-receptors. It is classified as a β1 selective (cardioselective) β-adrenergic receptor antagonist with no membranestability activity and no partial agonist activity. It is markedly the most hydrophilic of the currently available β- blockers and thus penetrates the lipid of cell membranes poorly
","Hypertension: The initial dose of Atenolol is 50 mg given as one tablet a day either alone or added to diuretic therapy. The full effect of this dose will usually be seen within one to two weeks. If an optimal response is not achieved, the dosage should be increased to Atenolol 100 mg given as one tablet a day. Increasing the dosage beyond 100 mg a day is unlikely to produce any further benefit.
Angina Pectoris: The initial dose of Atenolol is 50 mg given as one tablet a day. If an optimal response is not achieved within one week, the dosage should be increased to Atenolol 100 mg given as one tablet a day. Some patients may require a dosage of 200 mg once a day for optimal effect. Twenty-four hour control with once daily dosing is achieved by giving doses larger than necessary to achieve an immediate maximum effect. The maximum early effect on exercise tolerance occurs with doses of 50 to 100 mg, but at these doses the effect at 24 hours is attenuated, averaging about 50% to 75% of that observed with once a day oral doses of 200 mg.
Acute Myocardial Infarction: In patients with definite or suspected acute myocardial infarction, treatment with Atenolol I.V. Injection should be initiated as soon as possible after the patient's arrival in the hospital and after eligibility is established. Treatment should begin with the intravenous administration of 5 mg Atenolol over 5 minutes followed by another 5 mg intravenous injection 10 minutes later. In patients who tolerate the full intravenous dose (10 mg), Atenolol Tablets 50 mg should be initiated 10 minutes after the last intravenous dose followed by another 50 mg oral dose 12 hours later. Thereafter, Atenolol can be given orally either 100 mg once daily or 50 mg twice a day for a further 6-9 days or until discharge from the hospital. If bradycardia or hypotension requiring treatment or any other untoward effects occur, Atenolol should be discontinued.
",,"
+- Catecholamine-depleting drugs (eg, reserpine) may have an additive effect when given with beta-blocking agents. Patients treated with Atenolol plus a catecholamine depletor should therefore be closely observed for evidence of hypotension and/or marked bradycardia which may produce vertigo, syncope, or postural hypotension.
+- Calcium channel blockers may also have an additive effect when given with Atenolol.
+- Disopyramide is a Type I antiarrhythmic drug with potent negative inotropic and chronotropic effects. Disopyramide has been associated with severe bradycardia, asystole and heart failure when administered with beta blockers.
+- Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with beta blockers.
+- Beta blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two drugs are coadministered, the beta blocker should be withdrawn several days before the gradual withdrawal of clonidine. If replacing clonidine by beta-blocker therapy, the introduction of beta blockers should be delayed for several days after clonidine administration has stopped.
+- Concomitant use of prostaglandin synthase inhibiting drugs, eg, indomethacin, may decrease the hypotensive effects of beta blockers.
+- While taking beta blockers, patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge, either accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat the allergic reaction.
+- Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
+
","Atenolol is contraindicated in-
+
+- Sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure.
+- Those patients with a history of hypersensitivity to the atenolol or any of the drug product’s components.
+
","In a series of investigations in the treatment of acute myocardial infarction, bradycardia and hypotension occurred more commonly, as expected for any beta blocker. In addition, a variety of adverse efects has been reported with other beta-adrenergic blocking agents, and may be considered potential adverse efects of Atenolol.
+
+- Hematologic: Agranulocytosis.
+- Allergic: Fever, combined with aching and sore throat, laryngospasm, and respiratory distress.
+- Central Nervous System: Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation of time and place; short term memory loss; emotional lability with slightly clouded sensorium; and, decreased performance on neuropsychometrics.
+- Gastrointestinal: Mesenteric arterial thrombosis, ischemic colitis.
+- Miscellaneous: There have been reports of skin rashes and/or dry eyes associated with the use of beta-adrenergic blocking drugs. Discontinuance of the drug should be considered if any such reaction is not otherwise explicable. Patients should be closely monitored following cessation of therapy.
+- Other: Erythematous rash
+
","Pregnancy Category D. Caution should be exercised when Atenolol is administered to a nursing woman. Clinically significant bradycardia has been reported in breast-fed infants. Premature infants, or infants with impaired renal function, may be more likely to develop adverse effects.
","General: Patients already on a beta blocker must be evaluated carefully before Atenolol is administered. Initial and subsequent Atenolol dosages can be adjusted downward depending on clinical observations including pulse and blood pressure. Atenolol may aggravate peripheral arterial circulatory disorders.
Impaired Renal Function: The drug should be used with caution in patients with impaired renal function.
Geriatric Use:
+
+- Hypertension and Angina Pectoris: Due to Coronary Atherosclerosis: Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
+- Acute Myocardial Infarction: Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Evaluation of patients with hypertension or myocardial infarction should always include assessment of renal function.
+
","Elderly Patients or Patients with Renal Impairment: Atenolol is excreted by the kidneys; consequently dosage should be adjusted in cases of severe impairment of renal function. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, refecting greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. The following maximum oral dosages are recommended for elderly, renal impaired patients and for patients with renal impairment due to other causes:
+
+- Creatinine clearance 15-35 ml/min/1.73 m2: Maximum dosage 50 mg daily
+- Creatinine clearance <15 mL/min/1.73 m2: Maximum dosage 25 mg daily
+
+Some renal impaired or elderly patients being treated for hypertension may require a lower starting dose of Atenolol: 25 mg given as one tablet a day. Patients on hemodialysis should be given 25 mg or 50 mg after each dialysis; this should be done under hospital supervision as marked falls in blood pressure can occur.
","Overdosage with Atenolol has been reported with patients surviving acute doses as high as 5 g. One death was reported in a man who may have taken as much as 10 g acutely. The predominant symptoms reported following Atenolol overdose are lethargy, disorder of respiratory drive, wheezing, sinus pause and bradycardia. Additionally, common efects associated with overdosage of any beta-adrenergic blocking agent and which might also be expected in Atenolol overdose are congestive heart failure, hypotension, bronchospasm and/or hypoglycemia. Treatment of overdose should be directed to the removal of any unabsorbed drug by induced emesis, gastric lavage, or administration of activated charcoal. Atenolol can be removed from the general circulation by hemodialysis. Based on the severity of symptoms, management may require intensive support care and facilities for applying cardiac and respiratory support.
",,,"Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.
",12
+87,Astaxanthin,astaxanthin-87,,Supplements & adjuvant therapy,Strength and endurance & immune system,"Astaxanthin is indicated to-
+
+- Strong antioxidant
+- Improves cardiovascular health (Atherosclerosis, reduce cholesterol)
+- Improves immune function
+- Improves condition of skin
+- Protects skin from damage caused by sun (Reduces wrinkles, pimples and other signs of aging)
... Read more
Astaxanthin is indicated to-
+
+- Strong antioxidant
+- Improves cardiovascular health (Atherosclerosis, reduce cholesterol)
+- Improves immune function
+- Improves condition of skin
+- Protects skin from damage caused by sun (Reduces wrinkles, pimples and other signs of aging)
+- Improves recovery from central nervous system injuries
+- Protects from Parkinson’s disease, Dementia and Alzheimer's disease
+- Protects eyes from cataracts and macular degeneration
+- Reduces inflammation (Arthritis)
+- Reduces risk of infertility
+
+Also Astaxanthin effectively reduces oxidative damage to DNA, decreases the risk for many types
of cancer and stabilizes blood sugar.
","Supplements & adjuvant therapy
","Astaxanthin acts as an antioxidant by dual mode of action. It suppresses singlet oxygen and also inhibits lipid peroxidation. By these actions it reduces the harmful free radicals. Therefore acts as a very strong antioxidant. Astaxanthin is absorbed by passive diffusion into the intestinal epithelium alongside fatty acids. Then it is incorporated into lipoproteins, transported to the liver, via lymph and blood and partly resecreted with lipoproteins. More than 70% of the Astaxanthin is contained in high-density lipoprotein part of plasma. Highest concentration of Astaxanthin is in the small intestine, followed by subcutaneous fat, abdominal fat, spleen, liver, heart, kidney and skin and lowest in the muscles.
","Adults (18 years and older): Daily dose is 4 mg. Should be taken along with or immediately prior to meals in the morning.
+
+- 4 mg: As a strong antioxidant, improves cardiovascular health (Atherosclerosis, reduce cholesterol), improves immune function.
+- 4-8 mg: Improves condition of skin, protects skin from sun damage (Reduce wrinkles, pimples and other signs of aging), improves recovery from central nervous systehn injuries and protects eyes from cataracts and macular degeneration.
+- 8-12 mg: Reduces inflammation (Arthritis)
+- 16 mg: Reduces risk of infertility
+
",,"Concomitant intake of Astaxanthin with Cholestyramine, Colestipol, Mineral oil, Orlistat may reduce the absorption rate of Astaxanthin.
","Contraindicated for those with known allergies to Astaxanthin.
","No severe side effects have been reported yet.
","Both pregnant women and lactating mothers should avoid Astaxanthin supplements as no data on safety has been found yet.
",,,"No case of overdose has occurred with Astaxanthin.
",,,"Store in cool and dry place, away from direct light. Keep out of reach of children.
",10
+1528,Red Clover Isoflavones,red-clover-isoflavones-1528,,Herbal and Nutraceuticals,Hot flushes,"Red Clover Isoflavones is indicated for menopausal women, for the relief of menopause symptoms. It helps to relieve symptoms of menopause such as hot flushes and night sweats. It menopause related osteoporosis and bone density loss. It maintenance of cholesterol level
","Herbal and Nutraceuticals
","Red clover Isoflavones are a naturally occurring element with a chemical structure similar to that of steroidal estrogens. Isoflavones mimic the human bodies natural estrogen. As a result, red clover Isoflavones interact with the human estrogen receptor. Red clover Isoflavones preferentially activate the beta estrogen receptors found in the brain, bones and cardiovascular system. Red clover Isoflavones show very little activity in the alpha estrogen receptors found in breast and uterine tissue.
","The recommended dosage is 1-2 capsules per day depending on body weight and on the severity of symptoms. Each Red Clover Isoflavones capsule should be taken with a meal and at approximately the same time each day
",,"Efficacy of Tamoxifen is decreased if it is used concomitantly with red clover. Caution is advised if anti-coagulants, contraceptives, estrogen and progesterone like drugs are used with red clover.
","It is recommended that the diet should not be supplemented with Isoflavonoid phytoestrogens during therapy with reproductive hormones including estrogen, progestogen and androgen because of the potential risk of competitive inhibition.
","No adverse reactions are known at the recommended dosage. Animal data showed that excessive may reduce fertility
","Not recommended for use during pregnancy. Isoflavones are secreted in breast milk, so use during lactation is not recommended.
",,,,,,"The product should be stored at room temperature out of direct sunlight. Keep the medicine out of reach of children.
",9
+1736,"Qurs Mulayin [Scammony, Lavender, Fennel]",qurs-mulayin-scammony-lavender-fennel-1736,,Herbal and Nutraceuticals,Osmotic laxative,"
+- Qurs Mulayin acts as prebiotic, which stimulates the growth or activity of probiotics (friendly bacteria) in the digestive system in ways claimed to be beneficial to health.
+- Qurs Mulayin stimulates peristaltic movement.
+- Qurs Mulayin acts as gentle laxative and relieves constipation.
... Read more
+- Qurs Mulayin acts as prebiotic, which stimulates the growth or activity of probiotics (friendly bacteria) in the digestive system in ways claimed to be beneficial to health.
+- Qurs Mulayin stimulates peristaltic movement.
+- Qurs Mulayin acts as gentle laxative and relieves constipation.
+- Qurs Mulayin detoxifies and restores the functions of colon.
+- Qurs Mulayin reduces excess gas and cramping.
+- Qurs Mulayin helps to relieve irritable bowel syndrome (IBS).
+- Qurs Mulayin helps to relieve colic.
+- Qurs Mulayin enhances the absorption of nutrients from gastro intestinal tract
+- Qurs Mulayin tones up digestive and nervous systems.
+- Qurs Mulayin relieves chronic headache.
+
","Herbal and Nutraceuticals
","Qurs Mulayin is an effective herbal remedy in relieving constipation by stimulating peristaltic movements. Constipation means slow movement of faeces through the large intestine, it is often associated with large quantities of dry, hard faeces in the descending colon that accumulated because of the long time available for absorption of fluid. A sufferer may find it extremely painful or difficult in defaecation. Qurs Mulayin stimulates peristalsis, makes the stool soft for smooth laxation.
","1-2 tablet(s) with lukewarm water once daily or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in therapeutic dosage.
",,"Keep out of reach of the children.
",,,,,"Protect from light. Keep in cool & dry place. Shake well before use.
",8
+1988,Pumpkin [Cucurbita pepo],pumpkin-cucurbita-pepo-1988,,Herbal and Nutraceuticals,Benign prostatic hyperplasia (BPH),"Pumpkin is a plant. The seed and its oil are used to make medicine. Pumpkin is commonly used by mouth for symptoms of benign prostatic hyperplasia (BPH).
","Herbal and Nutraceuticals
","The chemicals in pumpkin seed cause an increase in urination (diuretic effect), which helps relieve bladder and prostate discomfort. Some chemicals might also reduce swelling (inflammation) in the prostate.
","For benign prostatic hyperplasia (BPH): 5 grams pumpkin seed twice daily. 1-2 tablets or capsules of pumpkin seed oil or extracts daily. 160 mg pumpkin seed oil 1-3 times daily in combination with saw palmetto and other ingredients.
",,,,"Pumpkin is LIKELY SAFE in food amounts. It is POSSIBLY SAFE to take pumpkin seed or pumpkin seed oil in medicinal amounts. Side effects from pumpkin products are rare.
","There isn't enough reliable information to know if pumpkin is safe to use in medicinal amounts when pregnant or breastfeeding. Stay on the safe side and stick with usual food amounts.
",,,,,,"Store below 25ºC, dry place and away from direct sunlight. Keep out of reach of children.
",7
+1503,Psyllium [Ispaghula Husk] + Senna Extract,psyllium-ispaghula-husk-senna-extract-1503,,Bulk-forming laxatives,Piles,"Psyllium fiber and standardized Senna extract is indicated in-
+
+- Constipation
+- Hemorrhoids or piles
+- Bowel regulation for bed ridden patient
+
","Bulk-forming laxatives, Herbal and Nutraceuticals
","Psyllium Fiber & Senna Extract has documented laxative effect for Psyllium or Ispaghula husk powder (Plantago ovata) and standardized Senna extract (Cassia angustifolia). When one spoonful of powder is mixed with water it forms an orange colored and flavored drink. Psyllium (bulk-forming laxative) contains mucilage and Senna extract (stimulant laxative) contains hydroxyanthracene glycosides (as Sennoside B) that helps to relieve constipation and normalizes bowel action. The additive effect of Psyllium Fiber & Senna Extract is ensured for its combination partners. This special combination preparation accelerates intestinal passage and increases water absorption to increase filling pressure. Psyllium Fiber & Senna Extract helps to reduce pain by easy bowel evacuation with soft stool for patients who are suffering from haemorrhoids (piles), rectal surgery and colon cancer. It has soothing effects on gastric and intestinal mucosa, gastric irritation and ulceration. Psyllium Fiber & Senna Extract helps to maintain serum cholesterol and blood glucose level.
","Adults and children over 12 years old: 1-2 spoonful at night with at least 150 ml water or as directed by physician. Intake of additional water will be helpful. This can be taken with fruit juice, milk and warm drink. And should not be taken until ½ to 1 hour after intake of other medications. Continuous use for more than 2 weeks requires medical supervision.
","
+- Take 1-2 spoonful of this powder with the provided spoon.
+- Put this powder into an empty glass.
+- Fill the glass with 150 ml water, stir and drink immediately.
+
","Chronic use may causes potassium deficiency which may increase the effectiveness of cardiac glycosides and may influence the action of antiarrhythmic drugs. Potassium deficiency can be increased by simultaneous application of thiazide diuretics, corticoadrenal steroids. A reduction of dose of insulin may be necessary for insulin dependent diabetic patients. The absorption of concurrently administered drugs can be delayed.
","Contraindicated for patients with pathological narrowing in gastrointestinal tract, intestinal obstructions, difficult-to-control diabetes mellitus, acutely inflamed intestinal diseases, e.g. Crohn's disease, ulcerative colitis, appendicitis and abdominal pain of unknown origin. Contraindicated for children under 12 years old.
","Occasionally allergic reaction may occur. Chronic use may cause loss of electrolytes (potassium) that will reverse upon discontinuation.
","Recommended but special precaution should be taken during first trimester of pregnancy.
","Drink immediately after preparation. Keep tightly closed after each use.
",,"Overdose may alter electrolyte and water balance.
",,,"Store in a cool and dry place, away from light and moisture. Keep out of reach of children.
",12
+1498,Probiotic Combination [4 Billion],probiotic-combination-4-billion-1498,https://medex.com.bd/attachments/PHOH5jfhPY2P5zmAG9qTfYIL1weS9J/probiotic-combination-4-billion-prescribing-information,Herbal and Nutraceuticals,"Lactose intolerance such as bloating, flatulence, diarrhea","This is indicated in the following indications-
+
+- Diarrhea
+- Digestive discomfort
+- Lactose intolerance
+- Vaginal infection
+- Antibiotic associated diarrhea
+
","Herbal and Nutraceuticals, Probiotic
","Studies of probiotic activity in recent years provide evidence that probiotics counter experimental and human gastrointestinal inflammation (human inflammatory bowel disease) by their effects on epithelial cell function, including epithelial cell barrier function, epithelial cytokine secretion and their antibacterial effects relating to colonization of the epithelial layer. It reduces gastrointestinal pH through stimulation of lactic-acid-producing bacteria; provide a direct antagonistic action on gastrointestinal pathogens. Moreover it competes with pathogens for binding and receptor sites. In addition, there is emerging evidence that probiotics induce regulatory T cells that act as a break on the effector T cells that would otherwise cause inflammation.
Lactobacillus acidophilus and Bifidobacterium bifidum appear to enhance the nonspecific immune phagocytic activity of circulating blood granulocytes. This effect may account, in part, for the stimulation of IgA responses in infants infected with rotavirus. Lactic acid bacteria, like strains of Lactobacillus acidophilus, Lactobacillus bulgaricus have also demonstrated antioxidant ability. Mechanisms include chelation of metal ions (iron, copper), scavenging of reactive oxygen species and reducing activity.
","1 or 2 probiotics capsules 3 times daily or as directed by the physician.
",,"None well documented.
","The use of probiotics is not advised in patients at risk of opportunistic infections and in those with badly damaged GI tracts.
","No known toxicity or side-effects.
","Probiotics are unlikely to reach the systemic circulation of the fetus & therefore are unlikely to cause harm. Probiotics are unlikely to be transferred into breast milk.
",,,,,,"Store below 25ºC, dry place and away from direct sunlight. Keep out of reach of children.
",9
+1887,Probiotic Combination [3.2 Billion],probiotic-combination-32-billion-1887,,Herbal and Nutraceuticals,Indigestion,"Indigestion
","Herbal and Nutraceuticals, Probiotic
",,,,,,,,,,,,,,2
+2069,Probiotic Combination [2.3 Billion],probiotic-combination-23-billion-2069,,Herbal and Nutraceuticals,,"It is indicated for vaginal irritation, vaginal discomfort, reduction of colonization of bad bacteria & yeast in the vagina. pH protection of vagina against imbalances. Re-establishment & maintenance of good bacteria in the vagina. It is also indicated for urinary tract infection.
","Herbal and Nutraceuticals, Probiotic
","A combination of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 has been associated with support of the female urogenital tracts of teens, premenopausal and post menopausal women.
","Take 1 to 2 capsules with food, preferably with breakfast daily. Or, as directed by the registered physician.
",,"No clinically significant drug interaction has been reported.
","This capsule is contraindicated with known hypersensitivity to any component of the formulation.
","No clinically significant adverse reactions have been observed in therapeutic dosage. Probiotics are likely safe for most people.
","It is safe to use during pregnancy and lactation.
",,,,,,"Keep out of reach of the children. Keep away from direct sunlight. Store below 30°C in a dry place.
",9
+2070,Probiotic Combination [2 Billion],probiotic-combination-2-billion-2070,,Herbal and Nutraceuticals,,"Lactobacillus reuteri is a natural supplement that contains the probiotic Lactobacillus reuteri NCIMB 30242, the first and only probiotic that safely supports healthy cholesterol in adults with moderately elevated cholesterol but within the normal range. Lactobacillus reuteri natural bacteria may help ... Read more
Lactobacillus reuteri is a natural supplement that contains the probiotic Lactobacillus reuteri NCIMB 30242, the first and only probiotic that safely supports healthy cholesterol in adults with moderately elevated cholesterol but within the normal range. Lactobacillus reuteri natural bacteria may help to promote overall digestive health and support the body's normal production of vitamin D3. It restores normal fora, used to treat bowel problems (such as diarrhea, irritable bowel), eczema, vaginal yeast infections, lactose intolerance and urinary tract infections.
","Herbal and Nutraceuticals, Probiotic
","Lactobacillus reuteri NCIMB 30242 is a natural, over-the-counter probiotic supplement. It was discovered through Proselect, UAS Lab's proprietary discovery enabling technology that identifies non-GMO probiotic candidates with the potential to promote better metabolic health and natural balance through the microbiome.
","Take one capsule with food twice daily. Or, as directed by the registered physician.
",,"No clinically signif icant drug interaction has been reported.
","This capsule is contraindicated with known hypersensitivity to any component of the formulation. Lactobacillus preparations are contraindicated in persons with a hypersensitivity to lactose or milk.
","No clinically signif icant adverse reactions have been observed in therapeutic dosage. Probiotics are likely safe for most people.
","Lactobacillus preparations have not been studied during pregnancy, in breastfeeding women, or in women trying to become pregnant. If you are pregnant, breastfeeding or trying to become pregnant, you should check with your healthcare provider before using it to ensure it is right for you.
",,,,,,"Keep out of reach of the children. Keep away from direct sunlight. Store below 30°C in a dry place.
",9
+1539,Proanthocyanidins,proanthocyanidins-1539,,Herbal and Nutraceuticals,Venous thrombosis,"Chronic venous insufficiency (edema), thrombosis (blood clot), diabetes and its complications, retinopathy, hypertension (high blood pressure) and its complications, allergy, asthma, endometriosis (premenstrual pain caused by endometrial tissue in places other than the uterus) and dysmenorrhea (painful menstruation), osteoarthritis, skin disorders & melasma (a dark pigmentation of the skin).
","Herbal and Nutraceuticals
","French maritime pine bark extract is made by extraction of the outer bark of Pinus pinaster. Recent research suggests significant antioxidant activity is primarily based on its proanthocyanidin content. Proanthocyanidins prevents the oxidation of LDL cholesterol, protects the DNA from free-radical damage, prevents stress-related blood clotting without increasing bleeding risk, increases nitric oxide synthesis leading to vasodilation, has profound anti-inflammatory activity, protects the skin from sun damage, dramatically improves wound healing while decreasing scarring, boosts many aspects of immune system function, and also lowers blood sugar while stimulating fat tissue breakdown.
","Generally, one capsule (50 mg) 2 times daily with meals for 2-3 months or as directed by the physician. A repeated course or long-term use is acceptable.
+
+- Hypertension, blood hyper-coagulation, impaired circulation: 50 mg twice daily
+- Diabetes: 50 mg twice daily
+- Retinopathy: 50 mg twice or thrice daily
+- Asthma: 1 mg/lb of body weight/day in two divided doses or 50 mg twice daily
+- Allergies: 50 mg twice daily
+- As an anti-inflammatory agent: 50 mg once or twice daily
+- Osteoarthritis: 50 mg twice daily
+- Dysmenorrhea/Endometriosis: 50 mg once or twice daily
+- Skin disorders/Melasma: 50 mg once or twice daily
+- Edema in venous insufficiency: 50 mg once daily minimum 2–4 weeks (For more advanced stages the daily dosage should be higher, 50 mg twice or thrice daily for 4 weeks). Once edema and symptoms have improved, a daily maintenance dosage of 50 mg may be considered.
+- As an antioxidant: 50 mg once daily
+
",,"There is no reported information of drug interaction resulting from simultaneous intake of Proanthocyanidins with other drugs.
","There are no known contraindications for Proanthocyanidins.
","No serious side effects have been reported. To avoid gastric upset, diarrhea & constipation, Proanthocyanidins should be taken with meals. Minor adverse effects including headache and dizziness may occur.
","As a general precaution, pregnant women should not take Proanthocyanidins within the first 3 months of pregnancy. Safety trials have demonstrated absence of mutagenic and teratogenic effects, no perinatal toxicity, and no negative effects on fertility. There are no adequate and well-controlled studies of Proanthocyanidins in children under the age of 6 years.
",,,,,,"Store in a cool and dry place, protect from light. Do not use the drug after expiry date. Keep out of reach of children.
",9
+1762,Prasarani Sandhan,prasarani-sandhan-1762,,Herbal and Nutraceuticals,Rheumatoid arthritis,"This is indicated in-
+
+- Rheumatoid arthritis
+- Lumbago
+- Sciatica
+
","Herbal and Nutraceuticals
","Prasarani (Paederia foetida): It contains iridiod glycosides, paederolone, paederone, paederine and paederinine. It has tonic, anti-inflammatory (antiphlogistic) and astringent activities. It is mainly used for arthritis and rheumatic ailments.
Rason (Allium sativum): It contains protein, minerals, thiamine, riboflavin, niacin, folic acid and amino acids- leucin & methionine. It is very useful drug for rheumatism and is used as an effective long term preventive treatment for all rheumatic conditions. It is effective in gout and sciatica.
Chitamul (Plumbago rosea): It contains plubbagin, sitosterol and glucoside. It is acrid, abortifacient, vesicant and stimulant. It is used in the treatment of rheumatism and paralytic affections.
","2 tea-spoonful's 2-3 times daily after meal or as directed by the registered physician.
",,,"Not reported.
","No side effect or adverse effect if used at recommended dose.
","Not recommended.
",,,,,,"Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.
",8
+874,Peppermint Oil,peppermint-oil-874,,Anticholinergics (antimuscarinics)/ Anti-spasmodics,Irritable bowel syndrome (IBS),"Peppermint Oil is indicated in Irritable bowel syndrome (IBS), Functional dyspepsia, Abdominal pain and spasm, Abdominal distension/bloating
","Anticholinergics (antimuscarinics)/ Anti-spasmodics, Herbal and Nutraceuticals
","Peppermint Oil helps to relieve both the painful abdominal spasm and uncomfortable bloating of IBS. It has a relaxant, antispasmodic effect especially on the muscles of the large bowel or colon and in bowel spasm, particularly large-bowel spasm. It is carminative, antibacterial, mucolytic. Peppermint Oil helps to treat unpleasant sensations of fullness and bloating and facilitates the passing of bowel gases, so relieving accompanying cramp like pain.
","Adults: 1 capsule 3 times daily with a glass of water. The dose may be increased to a maximum of 2 capsules 3 times daily or as directed by a physician.
Children (8 years and above): 1 capsule 3 times daily with a glass of water or a directed by a physician.
",,"Exacerbation of adverse effects if taken with alcohol; enteric-coated preparations containing peppermint oil should not be taken immediately with antacids.
","Contraindicated in patients with achlorhydria. Also contraindicated for infants due to the potential risk of spasm of the tongue or respiratory arrest.
",,"No known restrictions.
","Should not be taken with food or immediately after meals. Should be taken 30 to 60 minutes before meals. Must be swallowed whole, with a little liquid. Capsules must not be chewed or crushed.
",,,,,"Keep in a cool & dry place, away from direct sunlight. Keep out of reach of children.
",9
+1689,Penitab,penitab-1689,,Herbal and Nutraceuticals,Restlessness,"Penitab is indicated in-
+
+- Loss of memory
+- Dementia
+- Alzheimer’s disease
+- Parkinson’s disease,
+- Senility
+- Insomnia
+- Restlessness
+- Venous insufficiency
+- Skin diseases
+- Diarrhoea.
+
","Herbal and Nutraceuticals
","Penitab is a versatile herbal medicine which improves cognitive function and boosts up memory. Penitab helps to increase blood flow to the brain which facilitates the supply of nutrients and oxygen to the brain tissue. Penitab acts as the food for the brain. It serves as energy reservoir for brain function. Penitab improves working memory, attention, psychomotor function, perception and mental alertness. Penitab keeps the sensorium clear & alert.
","1-2 capsule(s) 2 times daily or as prescribed by the registered physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in therapeutic dosage.
",,"Keep out of reach of children.
",,,,,"Store in a cool and dry place away from light.
",8
+1694,Pechish,pechish-1694,,Herbal and Nutraceuticals,Diarrhoea,"Pechish is indicated in-
+
+- Amoebic dysentery
+- Bacillary dysentery
+- Diarrhoea
+- Gastro-intestinal colic.
+
","Herbal and Nutraceuticals
","Pechish is a unique formulation of highly efficacious medicinal plants for amoebic dysentery, bacillary dysentery, diarrhoea & gastro-intestinal colic. The synergistic action of the herbs normalizes the hyper-motility of the digestive system and promptly stops diarrhoea. It is also highly effective to eradicate causative organism (Shigella sp.) of bacillary dysentery.
","1-2 tablet(s) 2-3 times daily or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1522,Patrangasav,patrangasav-1522,,Herbal and Nutraceuticals,Vaginal leucorrhoea,"This syrup is indicated in leucorrhea, cervicitis, non-specific vaginitis and pelvic inflammatory diseases. Moreover, this syrup might be used in low back pain associated with leucorrhea, endometroiosis, disorder of the urogenital tract.
","Herbal and Nutraceuticals
","Woodfordia fruticosa: Woodfordia fruticosa belongs to the Lythraceae family possesses high content of tannins, which has astringent, stimulant, uterine sedative, anthelmintic and potent antibacterial properties. It minimizes the vaginal pH and thus prevents relapse. Study reveals that extract of Woodfordia fruticosa contains certain constituents like tannin with significant antibacterial properties, which enable to overcome the barrier in Gram negative bacterial cell wall. The inhibitory effect is comparable with standard antibiotics Amoxicillin and Ciprofloxacin. Moreover Woodfordia fruticosa flowers provide non-specific immunity. It stimulates reticulo endothelial system and release of cytokines from macrophages. Proliferation of bone marrow cells indicates the plausible release of colony stimulating factors, which further stimulates the immune system through generation of immune cells.
Hemidesmus indicus: Chemical analysis of the root showed the presence of coumarin, volatile oil and two sterols. 2-hydroxy-4 methoxy benzaldehyde is isolated from the root of the Hemidesmus indicus which has anti-inflammatory activity against chronic inflammation. Also the drug is revealed significant anti-fungal activity in experimental and clinical studies.
Acacia catechu: Acacia catechu is highly valuable for its powerful astringent and antioxidant activities. It exhibits various pharmacological effects like antipyretic, anti-inflammatory, antioxidant and antimicrobial activities. Catechins and taxifolin is principal constituent of Acacia catechu which have significant antimicrobial effects. Chronic gonorrhea can be treated with Acacia catechu.
Mangifera indica: Mangifera indica contains active substances like mangiferin, which has antibacterial, antiviral, anti-inflammatory and antiallergic activity. It inhibits mast cell degranulation.
","Adult: 3 teaspoonfuls (15 ml) 3 times daily after meal for 15 days or as directed by the physician.
",,,,"No health hazards or side effects are known in conjunction with the proper administration of designated therapeutic dosages. But in rare case high dose may cause burning sensation, diarrhea or may increase urine output.
","It should not be taken during pregnancy although medical literature has not reported any adverse effects related to fetal development during pregnancy or to infants who are breast-fed.
",,,,,,"Keep in a cool, dry place & away from direct sunlight.Keep the medicine out of the reach of children
",7
+1514,Panax Ginseng,panax-ginseng-1514,,Herbal and Nutraceuticals,,"Panax Ginseng capsule is indicated to reduce fatigue and stress, increase vitality strengthens immunity, while recovering after long term fever and weakness, as a stimulant, enhance libido, increase physical endurance, prevents impotence, adjuvant therapy for diabetes. Posses antioxidant property.
... Read more
Panax Ginseng capsule is indicated to reduce fatigue and stress, increase vitality strengthens immunity, while recovering after long term fever and weakness, as a stimulant, enhance libido, increase physical endurance, prevents impotence, adjuvant therapy for diabetes. Posses antioxidant property.
Primary Uses-
+
+- Adaptogen and general tonic
+- Increased athletic performance and endurance
+- Immunomodulatory effects
+
+Other Potential Uses-
+
+- Aphrodisiac; erectile dysfunction and fertility
+- Menopausal symptoms
+- Non-insulin dependent diabetes mellitus
+- Improved pulmonary function in treatment of severe, chronic respiratory disease; additive effect of antibiotic treatment for respiratory tract infection
+
","Herbal and Nutraceuticals
","Ginseng is an all-natural & clinically shown to increase body's oxygen uptake which is necessary to help make healthy energy. The pharmacological effects a) adaptogenic b) improvement of physical & mental performance. In human, some evidence suggests that ginseng can improve glycogen utilization, alcohol clearance, serum lipid level, and other metabolic parameters, which is taken as evidence of a pro-homeostasis, adaptogenic effect.
","Capsule: One Panax Ginseng capsule one or two times a day or advised by the physician.
Syrup: 2 teaspoonfuls 2 times daily after meal or as directed by the registered physician.
",,,"Ginseng can be taken with any other vitamin, minerals or herbal supplement. No known contraindications according to the German E Commission and World Health Organization (WHO). However, as with any supplement, consult with physician if you are taking prescription drugs.
","Over Ginseng's many years of use, no serious side effects or drug interactions have been reported.
","No known restrictions according to the American Herbal Products Association and the German E Commission, but controlled, long-term safety studies are lacking. In Traditional Chinese Medicine (TCM), ginseng root is included in prescriptions given during pregnancy, labor and postpartum.
","Over stimulation and insomnia have also been reported with ginseng and anecdotal evidence suggests that excessive doses may mildly elevate blood pressure and/or cause hyper sexuality. Safety in young children or individuals with severe hepatic or renal disease is not known.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+1781,Beclomethasone Dipropionate + Chloramphenicol + Clotrimazole + Lidocaine,beclomethasone-dipropionate-chloramphenicol-clotrimazole-lidocaine-1781,,Anti-fungal or anti-bacterial ear drops,Fungal infections,"Formidable combination for Ear infections-
+
+- Safe and effective combination in otitis externa & otitis media with the perforated ear.
+- Shows higher efficacy of Clotrimazole to treat Otomycosis.
+- Shows excellent pain reduction of lidocaine to treat acute otitis media.
+
","Anti-fungal or anti-bacterial ear drops
","Beclometasone, Chloramphenicol, Clotrimazole & Lidocaine which treats ear infections. Lidocaine is a local anesthetic which works by blocking pain signals from the nerves to brain thereby decreasing pain sensation. Beclometasone is a steroid medicine. It blocks the production of certain chemical messengers (prostaglandins) that make the ear red, swollen and itchy. Clotrimazole is an antifungal which stops the growth of fungi by preventing them from forming their own protective covering. Chloramphenicol is an antibiotic. It stops bacterial growth by preventing synthesis of essential proteins.
","Use 2 or 3 drops in the affected ear 2 to 3 times a day for 7 to 14 days
+
+- Otitis Externa: From 6 months & older.
+- Otitis Media: From 12 years & older.
+
",,,,"The following is a list of possible side effects that may occur from all constituting ingredients of Chloramphenicol Beclomethasone & Clotrimazole Ear Drops. This is not a comprehensive list. These side effects are possible but do not always occur. Some of the side effects may be rare but serious. Consult your doctor if you observe any of the following side effects, especially if they do not go away.
+
+- Inflammation Of The Skin
+- Irritation
+- Itchy Rash
+- Blisters
+- Peeling Or Flaking Of The Skin
+- Discomfort.
+
",,"Before using this drug, inform your doctor about your current list of medications, over-the-counter products (e.g. vitamins, herbal supplements, etc.), allergies, pre-existing diseases, and current health conditions (e.g. pregnancy, upcoming surgery, etc.). Some health conditions may make you more susceptible to the side effects of the drug. Take as directed by your doctor or follow the direction printed on the product insert. Dosage is based on your condition. Tell your doctor if your condition persists or worsens. Important counseling points are listed below-
+
+- Apply to the affected area two or three times a day
+- Avoid repeated courses
+- Avoid situations in which bruising or injury may occur
+- Bacterial infection
+- Cataracts
+- Check blood sugar levels closely
+
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",7
+1221,Beclomethasone Dipropionate (Nasal Spray),beclomethasone-dipropionate-nasal-spray-1221,https://medex.com.bd/attachments/xByRgHtWXOxLM8mFClpKaCzbtejobK/beclomethasone-dipropionate-nasal-spray-prescribing-information,Nasal Steroid Preparations,Rhinitis,"Prophylaxis and treatment of seasonal & perennial allergic rhinitis including hay fever & non-allergic (vasomotor) rhinitis. Prevention of recurrence of nasal polyps following surgical removal.
","Nasal Steroid Preparations
","Following topical administration into the nasal mucosa, Beclomethasone Dipropionate produces anti-inflammatory and vasoconstrictor effects. The exact mechanism of these actions remain unknown, but may involve reductions in the following: number of mediator cells (basophil, leukocytes and mast cells) at the epithelial level, number of eosinophils, sensitivity of sensory nerves to mechanical stimuli, secretory response to cholinergic receptor stimulation, and fibroblast activity. Other mechanisms may involve inhibition of capillary dilation and permeability, stabilization of lysosomal membranes and subsequent prevention of release of proteolytic enzymes.
","Dosage of intranasal Beclomethasone Dipropionate must be carefully adjusted according to individual requirements and response.
Adults: Recommended usual dosage: 02 (two) sprays (50 µgm/spray) in each nostril twice daily. For some patients, 01 (one) spray in each nostril 3 to 4 times daily may be preferred. Total daily doses of 400 µgm (08 sprays) should not generally be exceeded.
Children (6 to 12 years of age): Usual dose: 01 (one) spray in each nostril twice daily. Patients not adequately responding, or those with more severe symptoms may use 02 (two) sprays in each nostril twice daily.
Children under 6 years of age: Not recommended since safety profile studies have not been conducted. After the first few days, patients may be able to reduce their dosage to 100 µg (one spray in each nostril) once daily for maintenance therapy.
","How to use the Nasal Spray-
+
+- Shake the bottle gently and remove the dust cover.
+- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
+- Gently blow the nose to clear the nostrils.
+- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
+- Breathe out through your mouth.
+- Repeat the above steps in the same/other nostril for consecutive doses.
+
+Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-
+
+- Remove the dust cover.
+- Gently pull off the nasal applicator.
+- Wash the applicator and dust cover in warm water.
+- Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
+- Gently push the applicator back on the top of the bottle and re-fix the dust cover.
+
","None is known.
","Contraindicated in patients with a history of hypersensitivity to any of its components. Infections of the nasal passages and paranasal sinuses should be appropriately treated but do not constitute a specific contraindication to treatment with Beclomethasone nasal spray.
","Rare instances of nasal septum perforation have been reported following intranasal administration. As with other nasal sprays, dryness and irritation of the nose and throat, unpleasant taste & smell and epistaxis have been reported rarely. Rare instances of wheezing, cataracts, glaucoma and increased intra-ocular pressure have been reported following the intranasal use of Beclomethasone.
","Beclomethasone should be used during pregnancy, if the potential benefit justifies the potential risks to fetus. In addition, as there is natural increase in corticosteroid production during pregnancy, most women will require a lower exogenous corticosteroid dose and many will not need corticosteroid treatment during pregnancy. As other corticosteroids are excreted in human milk, caution should be exercised when Beclomethasone nasal spray is administered to a nursing woman.
","Infections of the nasal passages and paranasal sinuses should be appropriately treated but do not constitute a specific contraindication to treatment with Beclometasone nasal spray. Care must be taken while transferring patients from systemic steroid to Beclometasone Nasal spray if there is any reason to suppose that their adrenal function is impaired.
",,"Inhalation of excessive doses over a short time period may suppress hypothalamic pituitary adrenal (HPA) function, and no special emergency action need to be taken, rather treatment should be continued at recommended dose. HPA function recovers within one or two day
",,,"Store at a temperature not exceeding 30˚ C. Protect from light & moisture. Keep out of the reach of children.
",12
+109,Beclomethasone Dipropionate (Inhaler),beclomethasone-dipropionate-inhaler-109,https://medex.com.bd/attachments/TRJ0TquFyUeVzxEKDUolmcE8mXv1CC/beclomethasone-dipropionate-inhaler-prescribing-information,Respiratory corticosteroids,Sinusitis,"Beclometasone 50, 100 & 250 HFA Inhaler is indicated in the prophylactic management of mild, moderate, or severe asthma in adults or children. Beclometasone dipropionate given by inhalation offers preventative treatment for asthma. It provides effective anti-inflammatory action in the lungs with ... Read more
Beclometasone 50, 100 & 250 HFA Inhaler is indicated in the prophylactic management of mild, moderate, or severe asthma in adults or children. Beclometasone dipropionate given by inhalation offers preventative treatment for asthma. It provides effective anti-inflammatory action in the lungs with a lower incidence and severity of adverse effects than those observed when corticosteroids are administered systemically.
Mild asthma: Patients requiring symptomatic bronchodilator asthma medication on a regular basis.
Moderate asthma: Patients with unstable or worsening asthma despite prophylactic therapy or bronchodilator alone.
Severe asthma: Patients with severe chronic asthma and those who are dependent on systemic corticosteroids for adequate control of symptoms. Many patients who are dependent on systemic corticosteroids for adequate control of symptoms may be able to reduce significantly, or eliminate, their requirement for oral corticosteroids when they are transferred to high dose inhaled beclometasone dipropionate.
","Respiratory corticosteroids
","Beclomethasone dipropionate produces anti-inflammatory and vasoconstrictor effects. The mechanisms responsible for the anti-inflammatory action of beclomethasone dipropionate are unknown. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation. The direct relationship of these findings to the effects of beclomethasone dipropionate on allergic rhinitis symptoms is not known.
Biopsies of nasal mucosa obtained during clinical studies showed no histopathologic changes when beclomethasone dipropionate was administered intranasally.
Beclomethasone dipropionate is a pro-drug with weak glucocorticoid receptor binding affinity. It is hydrolyzed via esterase enzymes to its active metabolite beclomethasone-17-monopropionate (B-17-MP), which has high topical anti inflammatory activity.
","Beclometasone dipropionate Inhaler is for oral inhalation use only. Patients should be given a starting dose of inhaled beclometasone dipropionate appropriate to the severity of their disease. The dose may then be adjusted until control is achieved, or reduced to the minimum effective dose according to individual response.
Adults (including the elderly): The usual starting dose is 200 micrograms twice a day. In more severe cases the starting dose may need to increase to 600 to 800 micrograms per day which may then be reduced when the patient's asthma has stabilised. The total daily dose may be administered as two, three, or four divided doses
Children: 50 to 100 micrograms should be given two, three or four times daily in accordance to the response. Alternatively, 100 micrograms or 200 micrograms twice daily should be given. The usual starting dose is 100 micrograms twice daily. Beclometasone 250 Inhaler is not recommended for children.
Beclometasone 250 HFA Inhaler: The usual starting dose is 200 micrograms twice a day. In more severe cases the starting dose may need to increase to 600 to 800 micrograms per day which may then be reduced when the patient's asthma has stabilised. The total daily dose may be administered as two, three, or four divided doses.
There is no need to increase the dose in patients with hepatic or renal impairment.
","Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.
Following simple steps can help to use Inhaler effectively (According to ""
National Asthma Guidelines for Medical Practitioners"" published by Asthma Association):
+
+- Take off the cap.
+- Shake the inhaler (at least six times) vigorously before each use.
+- If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
+- Breathe out as full as comfortably possible & hold the inhaler upright.
+- Place the actuator into mouth between the teeth and close lips around the mouthpiece.
+- While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
+- Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
+- If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
+- After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
+- Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.
+
+
Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.
",,"Hypersensitivity to any of the components. Special care is necessary in patients with active or quiescent pulmonary tuberculosis.
","Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. Possible systemic effects include Cushing's syndrome, Cushingoid features, and adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, and glaucoma.
","There is inadequate evidence of safety in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intra-uterine growth retardation.
The use of beclometasone dipropionate in mothers breast feeding their babies requires that the therapeutic benefits of the drug be weighed against the potential hazards to the mother and baby.
","Patients should be instructed in the proper use of the inhaler, and their technique checked, to ensure that the drug reaches the target areas within the lungs. They should also be made aware that Beclometasone Inhaler has to be used regularly, every day, even when they are asymptomatic, for optimum benefit.
",,,,,"The Inhaler should be stored below 30° C, protected from direct sunlight and heat. The canister should not be broken, punctured or burnt, even when apparently empty. Keep away from eyes. Keep out of reach of children.
",10
+1592,Beclometasone Dipropionate + Formoterol Fumarate,beclometasone-dipropionate-formoterol-fumarate-1592,https://medex.com.bd/attachments/Chugw8bAgeHPqYeSqzwEOfrTlrnmLK/beclometasone-dipropionate-formoterol-fumarate-prescribing-information,Respiratory corticosteroids,COPD,"Asthma: Beclomethasone dipropionate/Formoterol fumarate dihydrate is indicated in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting β2-agonist) is appropriate: patients not adequately controlled with inhaled corticosteroids and 'as needed' ... Read more
Asthma: Beclomethasone dipropionate/Formoterol fumarate dihydrate is indicated in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting β2-agonist) is appropriate: patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled rapid-acting β2-agonist or patients already adequately controlled on both inhaled corticosteroids and long-acting β2-agonists.
COPD: Symptomatic treatment of patients with severe COPD (FEV1 <50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
","Respiratory corticosteroids
","Beclomethasone dipropionate given by inhalation at recommended doses has a glucocorticoid antiinflammatory action within the lungs, resulting in reduced symptoms and exacerbations of asthma with less adverse effects than when corticosteroids are administered systemically.
Formoterol is a selective β2-adrenergic agonist that produces relaxation of bronchial smooth muscle in patients with reversible airways obstruction. The bronchodilating effect sets in rapidly, within 1-3 minutes after inhalation, and has a duration of 12 hours after a single dose.
","Adults 18 years and above: One or two inhalations twice daily. The maximum daily dose is 4 inhalations.
Children and adolescents under 18 years: The safety and efficacy in children and adolescents under 18 years of age have not been established yet. No data are available with the drug in children under 12 years of age. Therefore the drug is not recommended for children and adolescents under 18 years until further data become available.
","Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.
Following simple steps can help to use Inhaler effectively (According to ""
National Asthma Guidelines for Medical Practitioners"" published by Asthma Association):
+
+- Take off the cap.
+- Shake the inhaler (at least six times) vigorously before each use.
+- If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
+- Breathe out as full as comfortably possible & hold the inhaler upright.
+- Place the actuator into mouth between the teeth and close lips around the mouthpiece.
+- While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
+- Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
+- If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
+- After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
+- Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.
+
+
Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.
","Beta-blockers (including eye drops) should be avoided in asthmatic patients. If beta-blockers are administered for compelling reasons, the effect of formoterol will be reduced or abolished. On the other hand, concomitant use of other beta adrenergic drugs can have potentially additive effects, therefore caution is required when theophylline or other beta adrenergic drugs are prescribed concomitantly with formoterol. Concomitant treatment with quinidine, disopyramide, procainamide, phenothiazines, antihistamines, monoamine oxidase inhibitors and tricyclic antidepressants can prolong the QTc-interval and increase the risk of ventricular arrhythmias.
","Contraindicated in patients with hypersensitivity to any component of this product.
","As the drug contains beclometasone dipropionate and formoterol fumarate dihydrate, the type and severity of adverse reactions associated with each of the compounds may be expected. Common side effects are pharyngitis, oral candidiasis, headache, dysphonia.
","There are no relevant clinical data on the use of the drug in pregnant women. Animal studies using beclometasone dipropionate and formoterol combination showed evidence of toxicity to reproduction after high systemic exposure. There are no relevant clinical data on the use of the drug in lactation in humans. Although no data from animal experiments are available, it is reasonable to assume that beclometasone dipropionate is secreted in milk, like other corticosteroids.
","The drug should be used with caution (which may include monitoring) in patients with cardiac arrhythmias, especially third degree atrioventricular block and tachyarrhythmias (accelerated and/or irregular heart beat), idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease, particularly acute myocardial infarction, ischaemic heart disease, congestive heart failure, occlusive vascular diseases, particularly arteriosclerosis, arterial hypertension and aneurysm. Caution should also be observed when treating patients with known or suspected prolongation of the QTc interval, either congenital or drug induced (QTc >0.44 seconds). Formoterol itself may induce prolongation of the QTc interval.
",,,,,"Prior to dispensing to the patient: Store in a refrigerator (2-8°C) (for a maximum of 15 months). After dispensing: Store at temperatures not exceeding 30°C (for a maximum of 2 months).
",11
+108,Basiliximab,basiliximab-108,https://medex.com.bd/attachments/X6oO5EYFKrSLMLvBrxBsPMe8SFnrWA/basiliximab-prescribing-information,Cytotoxic immunosuppressants,Organ transplantation,"Basiliximab is an immunosuppressant agent used to prevent immediate transplant rejection in people who are receiving kidney transplants, in combination with other agents. It has been reported that some cases of lichen planus have been successfully treated with basiliximab as an alternative therapy to ciclosporin. No short-term side effects have been reported
","Cytotoxic immunosuppressants
","Basiliximab functions as an IL-2 receptor antagonist by binding with high affinity to the alpha chain of the high affinity IL-2 receptor complex and inhibiting IL-2 binding. Basiliximab is specifically targeted against IL-2Rα, which is selectively expressed on the surface of activated T-lymphocytes. This specific high affinity binding of Basiliximab��to IL-2Rα competitively inhibits IL-2-mediated activation of lymphocytes, a critical pathway in the cellular immune response involved in allograft rejection. While in the circulation, Simulect (basiliximab) impairs the response of the immune system to antigenic challenges. Whether the ability to respond to repeated or ongoing challenges with those antigens returns to normal after Simulect is cleared is unknown
","Adults: In adult patients, the recommended regimen is two doses of 20 mg each. The first 20 mg dose should be given within 2 hours prior to transplantation surgery. The recommended second 20 mg dose should be given 4 days after transplantation. The second dose should be withheld if complications such as severe hypersensitivity reactions to Basiliximab or graft loss occur.
Pediatric: In pediatric patients weighing less than 35 kg, the recommended regimen is two doses of 10 mg each. In pediatric patients weighing 35 kg or more, the recommended regimen is two doses of 20 mg each. The first dose should be given within 2 hours prior to transplantation surgery. The recommended second dose should be given 4 days after transplantation. The second dose should be withheld if complications such as severe hypersensitivity reactions to Basiliximab or graft loss occur.
","Basiliximab is used as part of an immunosuppressive regimen that includes cyclosporine (MODIFIED) and corticosteroids. Basiliximab is for central or peripheral intravenous administration only. Reconstituted Basiliximab should be given either as a bolus injection or diluted to a volume of 25 mL (10-mg vial) or 50 mL (20-mg vial) with normal saline or dextrose 5% and administered as an intravenous infusion over 20 to 30 minutes. Bolus administration may be associated with nausea, vomiting and local reactions, including pain.
Basiliximab should only be administered once it has been determined that the patient will receive the graft and concomitant immunosuppression. Patients previously administered
Basiliximab should only be re-exposed to a subsequent course of therapy with extreme caution due to the potential risk of hypersensitivity.
Parenteral drug products should be inspected visually for particulate matter and discoloration before administration. After reconstitution, Basiliximab should be a clear-to-opalescent, colorless solution. If particulate matter is present or the solution is colored, do not use.
Care must be taken to assure sterility of the prepared solution because the drug product does not contain any antimicrobial preservatives or bacteriostatic agents.
","May diminish response to inactivated vaccines. May enhance the adverse/ toxic effect of live vaccines, avoid concomitant admin.
","Known hypersensitivity to basiliximab or any component of the formulation
","Serious side effect such as:
+
+- Pain or burning when you urinate
+- Easy bruising or bleeding, unusual weakness
+- Tremors, shaking
+- Fever, chills, body aches, flu symptoms, vomiting, diarrhea
+- Trouble breathing
+- Pale skin, feeling light-headed or short of breath, rapid heart rate, trouble
+
","Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. No maternal toxicity, embryotoxicity, or teratogenicity was observed in cynomolgus monkeys 100 days post coitum following dosing with basiliximab during the organogenesis period; blood levels in pregnant monkeys were 13-fold higher than those seen in human patients. Immunotoxicology studies have not been performed in the offspring. Because IgG molecules are known to cross the placental barrier, because the IL-2 receptor may play an important role in development of the immunesystem, and because animal reproduction studies are not always predictive of human response, Basiliximab should only be used in pregnant women when the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should use effective contraception before beginning Basiliximab therapy, during therapy, and for 4 months after completion of Basiliximab therapy.
Nursing Mothers: It is not known whether Basiliximab is excreted in human milk. Because many drugs including human antibodies are excreted in human milk, and because of the potential for adverse reactions, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","Re-exposure to a subsequent course of therapy in patient who has previously received basiliximab. Children, Pregnancy and lactation.
","Renal Impairment: There are no dosage adjustments provided in the manufacturer’s labeling.
Hepatic Impairment: There are no dosage adjustments provided in the manufacturer’s labeling.
","A maximum tolerated dose of Basiliximab has not been determined in patients. During the course of clinical studies, Basiliximab has been administered to adult renal transplantation patients in single doses of up to 60 mg, or in divided doses over 3-5 days of up to 120 mg, without any associated serious adverse events. There has been one spontaneous report of a pediatric renal transplantation patient who received a single 20-mg dose (2.3 mg/kg) without adverse events.
","36 days ± 14 days.
","Reconstitute 10 mg and 20 mg vial with 2.5 ml and 5 ml sterile water for inj, respectively. To prepare the soln for infusion, further dilute with 25 ml (10 mg) or 50 ml (20 mg) NaCl 0.9% solution or dextrose 5% in water.
","Store between 2-8°C. It is recommended that after reconstitution, the solution should be used immediately. If not used immediately, it can be stored at 2º C to 8º C for 24 hours or at room temperature for 4 hours. Discard the reconstituted solution if not used within 24 hours.
",15
+107,Barium Sulfate,barium-sulfate-107,https://medex.com.bd/attachments/lELNCbBiCDRVF7A9dRfuLbTWxlwq9U/barium-sulfate-prescribing-information,Contrast medium for diagnostic procedures,X-ray imaging,"Barium Suphate is used to help doctors examine the esophagus (tube that connect mouth and stomach), stomach and intestine using X-rays or computed tomography (CAT scan, CT Scan; a type of body scan that uses a computer to put together X-ray images to create cross sectional or three dimensional picture ... Read more
Barium Suphate is used to help doctors examine the esophagus (tube that connect mouth and stomach), stomach and intestine using X-rays or computed tomography (CAT scan, CT Scan; a type of body scan that uses a computer to put together X-ray images to create cross sectional or three dimensional picture of the inside of the body). Barium sulphate is a class of medications called radiopaque contrast media. Its works by coating the esophagus, stomach or intestine with a material that is not absorbed into the body so that diseased or damaged areas can be clearly seen by X-ray examination or CT scan.
","Contrast medium for diagnostic procedures
","Barium sulfate increases the absorption of x-rays as they pass through the body, thus delineating body structures, in which barium sulfate is localized.
Barium sulfate is an insoluble material which, because of its density, provides a positive contrast during x-ray examination. Barium sulfate is an inert radiopaque material which is not absorbed or metabolized and is eliminated intact from the body in a manner similar to other non-absorbed inorganic materials. Excretion rate is a function of gastrointestinal transit time.
","Barium Sulphate comes as a powder to be mixed with water, a suspension (liquid), a paste, and a tablet. The powder and water mixture and the suspension may be taken by mouth or may be given as an enema (liquid that is instilled into the rectum), and the paste and tablet are taken by mouth. Barium Sulphate is usually taken one or more times before an X-ray examinations or CT scan. If you are using a Barium Sulphate enema, the enema will be administered by medical staff at the testing center. If you are taking Barium Sulphate by mouth, you may be given the medication after you arrive at the testing center or you may be given the medication to take at home at specific times the night before and/or the day of your test. If you are taking Barium Sulphate at home, take it exactly as directed. Do not take more or less of it or take it more often or at different times than directed. Shake the liquid well before each use to mix the medication evenly. If you are given a powder to mix with water and take at home, be sure that you are also given directions for mixing and that you understand these directions. Ask your doctor or staff at testing center if you have any questions about mixing your medications. You will be given specific directions to follow before and after your test. You may be told to drink only clear liquid after a certain time the day before your test, not to eat or drink after a specific time, and/or to use laxatives or enemas before your test. You may also be told to use laxatives to clear the Barium Sulphate from your body after your test. Be sure that your understand these directions and follow them carefully. Ask your doctor or the staff at the testing center if you are not given directions or if you have questions about.
",,,"Barium sulfate products are contraindicated in patients with known or suspected obstruction of the colon, known or suspected gastrointestinal tract perforation, suspected tracheoesophageal fistula, obstructing lesions of the small intestine, pyloric stenosis or known hypersensitivity to barium sulfate formulations.
","Common side effects are: severe stomach pain, severe cramping, diarrhea, or constipation, sweating, ringing in your ears, confusion, fast heart rate, pale skin, weakness
","Safe use of barium sulfate during pregnancy has not been established. Barium sulfate should be used in pregnant women only if the possible benefits outweigh the potential risks. Radiation is known to cause harm to the unborn fetus exposed in utero.
","General: Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the requisite training and with a thorough knowledge of the particular procedure to be performed. A history of bronchial asthma, atopy, as evidenced by hay fever and eczema, a family history of allergy, or a previous reaction to a contrast agent warrant special attention. Caution should be exercised with the use of radiopaque media in severely debilitated patients and in those with marked hypertension or advanced cardiac disease.
Anaphylactic and allergic reactions have been reported during double contrast examinations in which glucagon has been used.
Ingestion of barium sulfate suspension is not recommended in patients with a history of food aspiration. If barium sulfate suspension is aspirated into the larynx, further administration of the suspension should be immediately discontinued.
Patient preparation for diagnostic gastrointestinal examinations frequently requires cathartics and a liquid diet. The various preparations can result in water loss for the patient. Patients should be rehydrated quickly following a barium sulfate suspension examination of the gastrointestinal tract.
Pregnancy: Safe use of barium sulfate during pregnancy has not been established. Barium sulfate should be used in pregnant women only if the possible benefits outweigh the potential risks. Elective radiography of the abdomen is considered to be contraindicated during pregnancy due to the risk to the fetus from radiation exposure. Radiation is known to cause harm to the unborn fetus exposed in utero.
","Pediatrics: Two deaths of infants from barium aspiration have been reported; however, the volume of aspirated material rather than the nature of the material was probably the responsible factor.
Geriatrics: Diagnostic studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of barium sulfate in the elderly. However, colon distention has caused electrocardiographic changes, especially in geriatric patients with a history of cardiac disease.
","In rare instances, immediate repeat oral examinations may lead to severe stomach cramps and diarrhea. Cases reported implicate a total dose in the range of 30 ounces (900 mL) of a 115% w/v barium sulfate suspension. Instances of this type have resolved spontaneously and they are not considered to be life-threatening.
",,,"Store at 25° C
",11
+1581,Baricitinib,baricitinib-1581,https://medex.com.bd/attachments/DtnHuw1nAk3PGwDNM0cZ79anTUErcM/baricitinib-prescribing-information,Immunosuppressant,Rheumatoid arthritis,"Baricitinib is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.
Limitation of Use: Use of Baricitinib in combination with other ... Read more
Baricitinib is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.
Limitation of Use: Use of Baricitinib in combination with other JAK inhibitors, biologic DMARDs or with potent immunosuppressants such as Azathioprine and cyclosporine is not recommended.
","Immunosuppressant
","Baricitinib is a Janus kinase (JAK) inhibitor. JAKs are intracellular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function. Within the signaling pathway, JAKs phosphorylate and activate Signal Transducers and Activators of Transcription (STATs) which modulate intracellular activity including gene expression. Baricitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs.
","The recommended dose of Baricitinib is 2 mg once daily. Baricitinib may be used as monotherapy or in combination with Methotrexate or other DMARDs.
",,"The recommended dose of Baricitinib in patients taking strong Organic Anion Transporter 3 (OAT3) inhibitors (e.g., probenecid) is 1 mg once daily
","
+- Anemia: Avoid initiation or interrupt Baricitinib in patients with hemoglobin less than 8 g/dL.
+- Lymphopenia: Avoid initiation or interrupt Baricitinib in patients with an Absolute Lymphocyte Count less than 500 cells/mm3.
+- Neutropenia: Avoid initiation or interrupt Baricitinib in patients with an Absolute Neutrophil Count less than 1000 cells/mm3.
+
","It is not known if Baricitinib will harm an unborn baby. Because of the potential for serious adverse reactions in nursing infants, advice an Baricitinib treated woman not to breastfeed.
","It is not known if Baricitinib will harm an unborn baby. Because of the potential for serious adverse reactions in nursing infants, advice an Baricitinib treated woman not to breastfeed.
","
+- Serious Infections: Avoid use of Baricitinib in patients with active, serious infection, including localized infections. If a serious infection develops, interrupt Baricitinib therapy until the infection is controlled. Do not give Baricitinib to patients with active tuberculosis.
+- Thrombosis: Use with caution in patients who may be at increased risk.
+- Gastrointestinal Perforations: Use with caution in patients who may be at increased risk.
+- Laboratory Assessment: Recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes, and lipids.
+- Vaccinations: Avoid use of Baricitinib with live vaccines
+
","Moderate Renal Impairment: Reduce dose to 1 mg once daily.
","In case of an overdose, it is recommended that the patient should be monitored for signs and symptoms of adverse reactions. Patients who develop adverse reactions should receive appropriate treatment.
",,,"Store below 30°C. Protect from light & moisture. Keep all medicines out of the reach of children.
",12
+106,Bambuterol Hydrochloride,bambuterol-hydrochloride-106,https://medex.com.bd/attachments/pFyauSkxXONwhyz4SqqUtLZccyimP0/bambuterol-hydrochloride-tablets-prescribing-information,Short-acting selective & β2-adrenoceptor stimulants,H. pylori infection,"Bambuterol is indicated for Bronchial asthma, chronic bronchitis, emphysema & other lung diseases where bronchospasm is a complicating factor.
","Short-acting selective & β2-adrenoceptor stimulants
","Bambuterol is an adrenergic β2 receptor agonist which predominantly stimulates β2 receptor, thus producing relaxation of bronchial smooth muscle, inhibition of release of endogenous spasmogens, inhibition of edema caused by endogenous mediators & increased mucocilliary clearance.
","Adult or Elderly: The recommended initial dose 10 mg. The dose may be increased to 20 mg after 1-2 weeks depending on the clinical effect.
Children 2-5 years: The recommended normal dose 10 mg (10 ml syrup).
Children 6-12 years: The recommended normal dose 10 mg (10 ml syrup). The dose may be increased to 20 mg.
",,"Succinylcholin, MAOIs (monoamine oxidase inhibitors), β2-blockers, corticosteroids, diuretics, muscle relaxants, sympathomimetic xanthine derivatives. Bambuterol may partly or totally inhibit the effect of β-blockers.
","Bambuterol is contraindicated in hepatic impairment, liver cirrhosis or severely impaired liver function.
","Common side effects are fatigue, nausea, palpitation, headache, dizziness & tremor.
","Pregnant women: There is no definite evidence of ill consequence during pregnancy. Nevertheless, the drug should not be used during the first trimester of pregnancy, unless the expected benefit is thought to outweigh any possible risk to the fetus.
Lactating mother: It is excreted in breast milk. So, patients taking this drug should not breast-feed.
","Reduce the dose in renal impairment, avoid in cirrhosis and severe hepatic impairment. Caution should be observed in patients with severe cardiovascular disorder, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.
","Impaired renal function (GFR 50 ml/min): The recommended starting dose is 5 mg, which may be increased to 10 mg after one to two weeks, depending on the clinical effect.
Impaired hepatic function: Not recommended because of unpredictable conversion to terbutaline.
",,,,"Keep away from light, store in a cool and dry place. Keep out of reach of children.
",11
+1883,Baloxavir Marboxil,baloxavir-marboxil-1883,https://medex.com.bd/attachments/0ph5hrvq8vJRTInzjOzRuDWJQGpo9L/baloxavir-marboxil-prescribing-information,Respiratory viral infections (Influenza),Influenza,"Baloxavir Marboxil is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for:
+
+- Treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours and who are: otherwise healthy, or at high risk of developing influenza-related complications.
... Read more
Baloxavir Marboxil is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for:
+
+- Treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours and who are: otherwise healthy, or at high risk of developing influenza-related complications.
+- Post-exposure prophylaxis of influenza in patients 12 years of age and older following contact with an individual who has influenza.
+
","Respiratory viral infections (Influenza)
","Baloxavir marboxil is a selective inhibitor of influenza cap-dependent endonuclease which prevents polymerase function and therefore influenza virus mRNA replication. It has shown therapeutic activity against influenza A and B virus infections, including strains resistant to current antiviral agents. This drug inhibits an enzyme required for viral replication, thus rapidly treating flu virus infection, and alleviating the symptoms associated with infection. A single dose of this agent was shown to be superior to placebo in relieving influenza symptoms and superior to both oseltamivir and placebo drug in virologic outcomes (marked by decreased viral load). The safety profile of Baloxavir marboxil compared favorably with that of oseltamivir, making it an effective treatment option for treatment of the flu virus, in one single dose.
","Treatment and Post-Exposure Prophylaxis of Influenza: Baloxavir Marboxil should be taken as a single dose as soon as possible and within 48 hours of influenza symptom onset for treatment of acute uncomplicated influenza or following contact with an individual who has influenza. Baloxavir Marboxil should be taken with or without food.
Recommended Single Oral Dose in Patients 12 Years of Age and Older:
+
+- Less than 80 kg: One 40 mg tablet
+- At least 80 kg: One 80 mg tablet
+
",,"
+- Avoid coadministration of Baloxavir Marboxil with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc).
+- Live attenuated influenza vaccines may be affected by antivirals.
+
","Baloxavir Marboxil is contraindicated in patients with a history of hypersensitivity to baloxavir marboxil or any of its ingredients.
","Adverse events reported in at least 1% of adult and adolescent influenza subjects treated with Baloxavir Marboxil included diarrhea (3%), bronchitis (3%), nausea (2%), sinusitis (2%), and headache (1%).
","There are no adequate and well-controlled studies with Baloxavir Marboxil in pregnant women to inform a drug-associated risk of adverse developmental outcomes. There are risks to the mother and fetus associated with influenza virus infection in pregnancy. There are no data on the presence of baloxavir marboxil in human milk, the effects on the breastfed infant, or the effects on milk production.
","Hypersensitivity such as anaphylaxis, angioedema, urticaria, and erythema multiforme: Initiate appropriate treatment if an allergic-like reaction occurs or is suspected.
Risk of bacterial infection: Serious bacterial infections may begin with influenza-like symptoms or may coexist with, or occur as, a complication of influenza. Baloxavir Marboxil has not been shown to prevent such complications. Prescribers should be alert to potential secondary bacterial infections and treat them as appropriate.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+994,Balanced Salt Solution,balanced-salt-solution-994,https://medex.com.bd/attachments/F6OjnQzIhC8AuvB9BaRhfVzWA7Jw54/balanced-salt-solution-prescribing-information,Irrigation during various surgical procedures,Irrigation solution,"This is an isotonic solution for use in irrigating tissues of the eyes. For irrigation during various surgical procedures of the eyes, ears, nose and/or throat.
","Irrigation during various surgical procedures
","This sterile Irrigating Solution is an isotonic solution for use in irrigating tissues of the eyes.
Calcium chloride is used to prevent or treat negative calcium balance. It also regulates action potential excitation threshold to facilitate nerve and muscle performance.
Potassium chloride is a major cation of the intracellular fluid. It plays an active role in the conduction of nerve impulses in the heart, brain and skeletal muscle; contraction of cardiac skeletal and smooth muscles; maintenance of normal renal function, acid-base balance, carbohydrate metabolism and gastric secretion. Sodium chloride is the major extracellular cation. It is important in electrolyte and fluid balance, osmotic pressure control and water distribution as it restores sodium ions. It is used as a source of electrolytes and water for hydration, treatment of metabolic acidosis, priming solution in haemodialysis and treatment of hyperosmolar diabetes. It is also used as diluents for infusion of compatible drug additives.
Magnessium Chloride: Acts as cofactor in numerous enzymatic reactions involving protein synthesis and carbohydrate metabolism; depresses CNS, blocks peripheral neuromuscular transmission, produces anticonvulsant effects.
Sodium chloride plays an important role in controlling the total body water and its distribution. Sodium is the main cation in the extracellular fluid and comprises >90% of total cations. The acetate component is an alternate source of bicarbonate by metabolic conversion in the liver.
","This ocular irrigating solution should be used according to standard format for each surgical procedure
",,,"Contraindicated in patients with known hypersensitivity to the products.
","When the corneal endothelium is abnormal, irrigation or any other trauma may result in bullous keratopathy. Postoperative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported. Their relationship to the use of balanced salt solution has not been established.
","Pregnancy Category: Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
","This solution contains no preservative and should not be used for more than one patient. Use only if container and seal are undamaged and solution is clear. The addition of any medication to isotonic solution may result in damage to intraocular tissue. There have been rare reports of corneal clouding or edema following ocular surgery in which isotonic solution was used as an irrigating solution. As in all surgical procedures appropriate measures should be taken to minimize trauma to the cornea and other ocular tissues.
",,,,,"Protect from light and store between 2° to 25° C. Do not freeze. Keep out of reach of children
",9
+105,Baclofen,baclofen-105,https://medex.com.bd/attachments/mLVOVLHV7hkuhstXpqEjmjjXtbYUZu/baclofen-tablets-prescribing-information,Centrally acting Skeletal Muscle Relaxants,Trigeminal neuralgia,"Baclofen is indicated in-
+
+- spasticity resulting from multiple sclerosis
+- flexor spasms and concomitant pain, clonus and muscular rigidity
+- skeletal muscle spasm resulting from rheumatic disorders
+- spinal cord injuries and other spinal cord diseases
+- cerebrovascular accidents or neoplastic or degenerative brain disease
+
","Centrally acting Skeletal Muscle Relaxants
","Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level by stimulating the GABAB receptors, which inhibits the release of glutamate and aspartate. It may also act at intraspinal sites producing CNS depression. Baclofen also exerts an antinociceptive effect.
","Adult & children over 10 years: 5 mg 3 times daily, preferably with or after food, gradually increased; max. 100 mg daily.
Children <10 years: Treatment is usually started with 2.5 mg (2.5 ml) given 4 times daily then raised according to requirement. Daily maintenance dose-
+
+- 12 month-2 years: 10-20 mg (10-20 ml)
+- 2 years-6 years: 20-30 mg (20-30 ml)
+- 6 years-10 years: 30-60 mg (30-60 ml)
+
",,"
+- Increased sedation may occur if Baclofen is taken with agents acting on the central nervous system, alcohol or synthetic opiates. The risk of respiratory depression is also increased.
+- Combined treatment with Baclofen and antihypertensives is likely to increase the fall in blood pressure; therefore the dosage of antihypertensive medication should be adjusted accordingly.
+- The concomitant administration of Baclofen and tricyclic antidepressants may potentiate the pharmacological effects of Baclofen resulting in pronounced muscular hypotonia.
+- In patients with Parkinsons disease receiving treatment with Baclofen and levodopa and carbidopa, there have been several reports of mental confusion, hallucinations, headaches, nausea and agitation.
+- The concurrent use of MAO inhibitors and Baclofen may result in increased CNS depressant effects. Caution is advised and the dosage of one or both agents should be adjusted accordingly.
+- Caution should be exercised when administering Baclofen and magnesium sulphate or other neuromuscular blocking agents since a synergistic effect may theoretically occur.
+
","Baclofen is contraindicated in patients with hypersensitivity to any component of this product.
","The most common adverse reactions associated with Baclofen are transient drowsiness, daytime sedation, dizziness, weakness and fatigue.
+
+- Central Nervous System: Headache (<10%), insomnia (<10%), and rarely, euphoria, excitement, depression, confusion, hallucinations, paraesthesia, nightmares, muscle pain, tinnitus, slurred speech, co-ordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizures, respiratory depression.
+- Cardiovascular: Hypotension (<10%), rare instances of dyspnoea, palpitation, chest pain, syncope.
+- Gastrointestinal: Nausea (approximately 10%), constipation (<10%) and rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhoea and positive test for occult blood in stool.
+- Genitourinary: Urinary frequency (<10%) and rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, haematuria.
+- Other: Instances of rash, pruritus, ankle oedema, excessive perspiration, weight gain, nasal congestion, visual disturbances, hepatic function disorders and paradoxical increase in spasticity. Muscular hypotonia of a degree sufficient to make walking or movement difficult may occur but is usually relieved by readjusting the dosage. For this purpose, the daytime dosage may be reduced and the evening dosage increased.
+
","Pregnancy category B3. Safe use of Baclofen during pregnancy has not been established. Baclofen crosses the placental barrier. Baclofen should only be administered to pregnant women when in the judgement of the physician concludes that the potential benefits outweigh the possible hazards. Baclofen is excreted in breast milk however evidence to date suggests that the quantities are so small that no undesirable effects on the infant would be expected.
","
+- Lower doses (approximately 5 mg per day) should be used for patients with impaired renal function or those undergoing chronic haemodialysis.
+- Patients suffering not only from spasticity but also from psychotic disorders, schizophrenia, depressive or manic disorders or confusional states should be treated cautiously and closely monitored as exacerbations of these disorders may occur.
+- In patients with epilepsy and muscle spasticity, Baclofen may be used under appropriate supervision and provided that adequate anticonvulsive therapy is continued. Lowering of the convulsion threshold may occur and seizures have been reported after the cessation of Baclofen therapy or with overdose.
+- Baclofen should be used with caution in patients with or with a history of peptic ulcers, cerebrovascular diseases, or hepatic, renal or respiratory failure.
+- Careful monitoring of respiratory and cardiovascular function is essential especially in patients with cardiopulmonary disease and respiratory muscle weakness.
+- During treatment with Baclofen, neurogenic disturbances affecting emptying of the bladder may improve. However in patients with preexisting sphincter hypertonia, acute retention of urine may occur. Baclofen should be used with caution in these circumstances.
+- Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerance to the medicine.
+- Appropriate laboratory tests should be performed periodically in patients with hepatic diseases or diabetes mellitus to ensure that no medicine induced changes in these underlying diseases have occurred.
+
",,"Gastric lavage is important in case of severe overdose.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+104,Bacitracin Zinc + Polymyxin B Sulfate,bacitracin-zinc-polymyxin-b-sulfate-104,,Ophthalmic antibacterial drugs,Diaper rash,"This ophthalmic ointment is indicated in the treatment of bacterial infections of the eye and its adnexa including conjunctivitis, keratitis, corneal ulceration and ulcerative blepharitis. It may be applied to prevent ocular infection both pre and post operatively.
","Ophthalmic antibacterial drugs
","This ophthalmic ointment is a sterile antimicrobial ointment for ophthalmic use, cointaining Polymixin-B sulphate and Bacitracin Zinc.
Polymixin-B sulphate and Becitracin Zinc are both bactericidal antibiotics, The former exerts its action by binding with the cellular membrane and the later by inhibiting bacterial cell wall development.
","Apply the ointment every 3 to 4 hourly for 7 to 10 days, depending on the severity of the infection or as directed by the physician.
",,,"Polytracin is contraindicated in those individuals who have shown hypersensitivity to Polymixin-B sulphate, Becitracin Zinc or to cross sensitizing substances.
","Sometimes this ointment may be absorbed in the blood, but shows no blood related toxicity. Moreover Allergic reaction, eye irritation, eye redness, itching, swelling may occur.
","Bacitracin Zinc: Pregnancy Category C
Polymyxin B Sulphate: Pregnancy Category B
Lactation: Undetermined
",,,,,,,7
+1474,Bacillus Clausii spores,bacillus-clausii-spores-1474,https://medex.com.bd/attachments/8pDYQDNsAld80Of3X2obQgyz1xXqcU/bacillus-clausii-spores-prescribing-information,,Diarrhoea,"Bacillus clausii spores is used for managing the alterations of the intestinal bacterial flora. Bacillus clausii spores restores the equilibrium of the intestinal flora changed during diarrhoea or in the course of thera-pies with antibiotics or chemo-therapy, contributing to correct the consequent dysvitaminosis (that is the imbalance of production and assimilation of the vitamins).
","Other antibiotic
","Bacillus clausii spores is a probiotic which is useful for the management of imbalance of intestinal bacterial flora due to diverse causes. The possible presence of corpuscles visible in the vials of Enterogermina is due to aggregates of Bacillus clausii spores and does not, therefore, indicate that the product has undergone any changes.
","Adults: from 2 to 3 mini bottles a day
Children: from 1 to 2 mini bottles a day
Infants: from 1 to 2 mini bottles a day
Do not exceed the instructed doses without the advice of the professional. Bacillus clausii spores is presented in the form of an oral suspension in water and is available as 5 ml mini bottles. One pack contains 10 ready-to-drink mini bottles.
","Take Bacillus clausii spores at regular intervals during the day. Consult the professional if the condition recurs or if you have noticed any recent change in the nature of problems. Use only for brief periods of Management.
It is necessary to shake the mini bottle before use. To open the mini bottle rotate the upper part and detach it. Take the content as such or dilute it in water or other drinks (for example; Milk, Tea, Orange juice). Once open, consume it within a short period to avoid contamination of the suspension.
",,"Hypersensitivity towards the components or other closely related substances.
","No side effects have been reported with the use of Enterogermina. However, it is important to communicate any undesirable effects.
","Bacillus clausii spores can be used during pregnancy & lactation
","During antibiotic therapy, the product should be administered in the interval between one dose of antibiotic and the next. Keep out of the reach of children. Contact your doctor if the condition worsen after 2-3 days of usage.
",,"Excessive doses of Enterogermina do not produce side effects. However, it is better to follow the recommended doses. While there are no particular problems associated with missing a dose, it is advisable to complete the daily dose for best results. Remember that the correct and careful administration increases its effectiveness.
",,,"The un-opened mini bottles of Enterogermina are stable for a period of 24 months. Do not use Enterogermina after the expiry date on the label. Store at a temperature not higher than 30°C.
",11
+101,Aztreonam,aztreonam-101,https://medex.com.bd/attachments/UNQ7HuyhNQ12GDgNvCyHwOOee788BK/aztreonam-injection-prescribing-information,Other beta-lactam Antibiotics,Urinary tract infection,"Aztreonam is indicated in the treatment of the following infections caused by susceptible aerobic Gram-negative micro-organisms
Urinary tract infections: Pyelonephritis, cystitis (initial and recurrent) and asymptomatic bacteriuria (including those due to pathogens resistant ... Read more
Aztreonam is indicated in the treatment of the following infections caused by susceptible aerobic Gram-negative micro-organisms
Urinary tract infections: Pyelonephritis, cystitis (initial and recurrent) and asymptomatic bacteriuria (including those due to pathogens resistant to the aminoglycosides, cephalosporins or penicillins).
Gonorrhea: Acute uncomplicated urogenital or anorectal infections.
Lower respiratory tract infections: Including pneumonia, bronchitis and lung infections in patients with cystic fibrosis.
Skin and soft tissue infections: Postoperative wounds, ulcers and burns.
Meningitis: Caused by Haemophilusinfluenzae or Neisseria meningitidis.
Gynecological infections: Pelvic Inflammatory Disease (PID), endometritis and pelvic cellulitis.
Intra-abdominal infections: Peritonitis.
Bacteremia/ septicemia: Septicemia caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa,Proteus mirabilis, Serratia marcescens and Enterobacter species.
Bone and joint infections: Osteomyelitis,septic arthritis.
Aztreonam is also indicated for adjunctive therapy to surgery in the management of infections caused by susceptible organisms. Patients with serious Pseudomonas infections may benefit from concurrent use of Aztreonam and an aminoglycoside because of their synergistic action.
","Other beta-lactam Antibiotics
","Aztreonam is a synthetic bactericidal monobactam antibiotic. It inhibits bacterial cell wall synthesis by blocking peptidoglycan crosslinking. The inhibition of bacterial cell wall synthesis occurs due to a high affinity of Aztreonam for penicillin binding protein 3 (PBP3). By binding to PBP3, Aztreonam inhibits the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins. It is possible that Aztreonam interferes with an autolysin inhibitor.
","Adults: The usual dose of Aztreonam is 3 to 4 gm daily (maximum recommended dose is 8 gm daily). The dosage and route of administration should be determined by the susceptibility of the causative organisms, severity of infection and the condition of the patient. In case of Pseudomonas aeruginosa infections, 2 gm every 6 or 8 hours is recommended.
Children: The usual dosage for patients older than one week is 30 mg/kg/dose every 6 or 8 hours. For severe infections in patients 2 years of age or older, 50 mg/kg/dose every 6 or 8 hours is recommended.Dosage information is not yet available for new-born less than 1 week old.
Dosage Guideline for adult:
+
+- Urinary tract infections: 500 mg or 1 gm; 8 or 12 hourly
+- Moderately severe systemic infections: 1 g or 2 gm; 8 or 12 hourly
+- Severe systemic or life-threatening infections: 2 gm; 6 or 8 hourly
+- Maximum recommended dose is 8 gm/ day.
+
+
Dosage Guideline or pediatric:
+
+- Mild to moderate infections: 30 mg/kg; 8 hourly
+- Moderate to severe infections (2 years or older): 50 mg/kg; 6 or 8 hourly
+- Maximum recommended dose is 120 mg/ kg/ day.
+
","Intramuscular administration: The dose should be given by deep injection into a large muscle mass. Aztreonam is well tolerated and should not be administered with any local anesthetic agent. For each gram of Aztreonam add at least 3 ml water for injection BP and shake well.
Intravenous administration: A bolus injection may be used to initiate therapy. The dose should be slowly injected directly into a vein, or the tubing of a suitable administration set, over a period of 3 to 5 minutes.
For infusion: Each gram of Aztreonam should be initially constituted with at least 3 ml of water for injection BP. The resulting solution should be diluted with an appropriate infusion solution to a final concentration not exceeding 2% w/v (at least 50 ml solution per gram Aztreonam). The Aztreonam infusion should be administered over a 20-60 minute period. A number of intravenous solutions may be used as diluents for the administration of Aztreonam by intravenous infusion.These include sodium chloride injection, dextrose and mixed injections of sodium chloride and dextrose, Ringers and lactated Ringers injection,water for injection etc.
","Concomitant administration of probenecid or furosemide and Aztreonam causes clinically insignificant increases in the serum levels of Aztreonam.
","This preparation is contraindicated in patients with known hypersensitivity to Aztreonam or any other component in the formulation.
","Local reactions such as phlebitis/thrombophlebitis following IV administration and discomfort/swelling at the injection site following IM administration may occur. Systemic reactions like diarrhea, nausea and/or vomiting, and rash may occur. Other side effects include anaphylaxis, angioedema, bronchospasm, pancytopenia, neutropenia, thrombocytopenia, anemia, eosinophilia, leukocytosis, thrombocytosis, abdominal cramps, dermatitis, urticaria, pruritus, hypotension, flushing, seizure, weakness, headache, fever, malaise may occur.
","Pregnancy Category B. Aztreonam crosses the placenta and enters the fetal circulation. So it should be used during pregnancy only if the potential benefit justifies the potential risk.
Aztreonam is excreted in breast milk in concentrations that are less than 1% of concentrations determined in simultaneously obtained maternal serum. Temporary discontinuation of nursing is recommended.
","In patients with impaired hepatic or renal function, appropriate monitoring is recommended during therapy.
","Renal Impairment: In patients with impaired renal function, the normal recommended initial dose should be given. This should be followed by maintenance doses as below:
Creatinine clearance (10–30 ml/min): Maintenance dose is half of the initial dose.
Creatinine clearance (Less than 10 ml/min): One quarter of the initial dose.
The normal dose interval should not be altered. In patients on haemodialysis, a supplementary one eighth of the initial dose should be given after each dialysis.
Recommended for children of one week and older. Aztreonam for injection should be administered intravenously to pediatric patients with normal renal function. There are insufficient data regarding intramuscular administration to pediatric patients or dosing in pediatric patients with renal impairment.
","If necessary, Aztreonam may be cleared from the serum by hemodialysis and/or peritoneal dialysis.
",,,"Store in a cool & dry place, protected from light & moisture. Keep all medicines out of reach of children.
",13
+1865,Azithromycin Dihydrate (Ophthalmic),azithromycin-dihydrate-ophthalmic-1865,,Macrolides,Conjunctivitis,"Azithromycin Eye Drops is indicated for the treatment of bacterial conjunctivitis caused by CDC coryneform group G, Haemophilus influenzae, Staphylococcus aureus, Streptococcus mitis group, and Streptococcus pneumonia.
","Macrolides
","Azithromycin is acid-stable and can therefore be taken orally with no need of protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. Time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.
Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.
Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:
+
+- Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
+- Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
+- Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
+- Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
+- Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
+- Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia
+
","Children of one year of age and adults: Instill 1 drop in affected eye(s) twice daily for the first 2 days then once daily for the next 5 days.
Pediatric Use: The safety and effectiveness of Azithromycin Eye Drops in pediatric patients below 1 year of age have not been established.
Children less than one year of age: Not recommended.
",,"Drug interaction studies have not been conducted with Azithromycin Eye Drops.
","Hypersensitivity to any component of the preparation.
","Eye irritation, contact dermatitis, corneal erosion, dry eye, punctate keratitis etc.
","Pregnancy Category B. In the animal studies, no evidence of harm to the fetus due to Azithromycin was found. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if clearly needed. It is not known whether Azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Azithromycin is administered to a nursing woman.
","Azithromycin Eye Drops is indicated for topical ophthalmic use only and should not be administered systemically, injected subconjunctivally, or introduced directly into the anterior chamber of the eye.
",,,,,"Store unopened bottle under refrigeration at 2°C to 8°C. Once the bottle is opened, store it at 25°C for up to 14 days. Discard after the 14 days of opening.
",10
+1765,Stevia Rebaudiana,stevia-rebaudiana-1765,,Herbal and Nutraceuticals,Artificial sweetener,"Stevia can be used as sweetener in different foods like pudding, milk products, jelly, tea, coffee, hot and cold beverage, fruit juice etc.Due to zero calorie sweetener it is an excellent preparation for the health conscious people, diabetes & obese patients. It is also suitable for everyone including children who wants to reduce calorie intake.
","Herbal and Nutraceuticals
","The main glycosides of stevia include stevioside and rebaudoside. Stevioside (6 to 18% in leaves) is the sweetest glycoside which has antidiabetic, sweetening & hypotensive effects.
","Normally 3 to 4 drops in a cup of tea/coffee is enough to sweeten the drink.
",,"Not yet known.
",,"No known side effects are found.
","Should be avoided.
",,,,,,"Keep all medicines out of the reach of children. Store in a cool and dry place protected from light.
",8
+1516,St. John’s Wort,st-johns-wort-1516,,Herbal and Nutraceuticals,Insomnia and sleep disturbances,"St. John’s Wort is indicated in-
+
+- Depression
+- Insomnia
+- Seasonal Affective Disorder (SAD)
+- Obsessive Compulsive Disorder (OCD)
+
","Herbal and Nutraceuticals
","St. John’s Wort is an herb which is most commonly used to treat for mild to moderate depression and conditions that sometimes go along with depression such as anxiety, tiredness, loss of appetite and insomnia. The main components of St. John’s Wort are Hypericin and Hyperforin which are responsible for its effects against depression. Although the exact mechanism of action of St. John’s Wort is unknown but it may inhibit the reuptake of Serotonin and Noradrenaline, inhibit Monoamine Oxidase (MAO), up-regulate Serotonin receptor, and reduce depression.
","The recommended dose of St. John’s Wort capsule in adults is 1 capsule 3 times daily or as prescribed by the physician.
",,"Symptoms of St. John’s Wort overdose may include dry mouth, dizziness and diarrhea.
",,"St. John’s Wort is generally safe for most people. It sometimes may cause dry mouth, dizziness, constipation and diarrhea.
","St. John’s Wort is not recommended for use during pregnancy.Because of the possible risk to the infant, breast-feeding while using this drug is not recommended.
","St. John’s Wort should be used cautiously with drugs metabolized by Cytochrome P450 and drugs that lower the seizure threshold.
",,,,,"Keep out of reach of the children. Keep away from direct sunlight; store in a cool and dry place.
",9
+1513,Spirulina,spirulina-1513,,Herbal and Nutraceuticals,Runny nose,"Spirulina is used for the treatment and prevention of malnutrition, diabetes, arthritis, asthma, hyperglycemia, anemia, allergic rhinitis and to enhance immunity. Spirulina helps to maintain healthy eyes and skin.
","Herbal and Nutraceuticals
","Spirulina has such positive TTutritionafcontent that it is called the world's richest whole-food which can be found naturally. It is very high in protein with low calorie content (only coming in at 2.9 calories per gram) using this as a supplement for protein specifically this is less than % the amount of calories in protein per gram, Spirulina is the highest source of B-12, essential for healthy nerves and tissue, especially for vegetarians. Due to large amount of iron in spirulina, it helps to promote the creation of new red blood cells too. Not only does spirulina contain high protein content within it, but it also has nutrients in it which increase the body's ability to absorb protein, This means that it even makes any other protein being consumed by the person more effective than if they had just consumed the protein alone. ln this way, spirulina may even be a better source of protein than most meal. Spirulina contains a concentration of very single amino acid as well. These are amino acids that the body cannot survive without, but we cannot produce ourselves which means we have to get them through other dietary means. Spirulina contains approximately 100 nutrients and minerals. Furthermore it has fatty acids that help reduce bad cholesterol in our body and antioxidants that help strengthen our immune system, fight free radicals and slow down the aging process. It is recommended to people whose intake of nutritious food is anadequate.
How does it work-
+
+- About 60% of spirulina dry weight is protein which is essential for growth and cell regeneration. Besides this it had sufficient vitamins and minerals within, With its high digestibility, spirulina has proven to fight malnutrition in impoverished communities by helping the body absorb nutrients when it has lost its ability to absorb normal forms of food.
+- Every 10 grams of spirulina can supply up to 70% of the minimum daily requirements for iron. Being rich in iron, magnesium and trace minerals spirulina is easier to absorb than iron supplements to fight anemia effectively.
+- Spirulina is rich in gamma-linolenic acid or GLA, a compound found in breast milk that helps develop healthier babies.
+- Another health benefit of spirulina is that it stimulates beneficial flora like lactobacillus and bifidobacterial in our digestive tract to promote healthy digestion and proper bowel function. It acts as a natural cleanser by eliminating mercury and other deadly toxins commonly ingested by the body.
+
","2 to 4 capsules daily or as advised by the physician.
",,"There are no reports suggesting that spirulina interacts with any conventional medication.
","Spirulina is contraindicated in those who are hypersensitive to any component of this product.
","Spirulina is generally well tolerated. Occasional diarrhea, gastrointestinal discomfort, such as nausea have been reported. Also there are few reports of allergic reactions to spirulina containing supplements.
","Before taking spirulina pregnant or breast-feeding women should talk to the physician.
","Before taking spirulina pregnant or breast-feeding women should talk to the physician.
",,,,,"Store in a cool and dry place. Keep away from direct sunlight. Keep out of reach of the children.
",10
+987,Silymarin [Milk thistle],silymarin-milk-thistle-987,,"Cholagogues, Cholelitholytics & Hepatic Protectors",Jaundice,"Silymarin (Milk thistle) is indicated for the treatment and prevention of-
+
+- Liver disease, (non-alcoholic & alcoholic)
+- Liver cirrhosis, (non-alcoholic & alcoholic)
+- Infectious hepatitis
+- Drug-induced hepatitis
+- Liver disease secondary to diabetes mellitus
+- Toxicity of narcotics
+- Fatty liver
+- Jaundice
+
","Cholagogues, Cholelitholytics & Hepatic Protectors, Herbal and Nutraceuticals
","Silymarin, a flavonoid complex of Silybum marianum or Milk thistle, is the biologically active component. It provides hepatocellular protection through toxin blockade at the membrane level, enhances protein synthesis, antioxidant activity, anti-fibrotic activity and possible anti-inflammatory or immunomodulating effects.
","1 capsule 2 to 3 times daily or as directed by a physician.
",,"Concomitant use of silymarin and butyrophenones or phenothiazines has resulted in the reduction of lipid peroxidation.
","Contraindicated in patient with a known hypersensitivity to silymarin.
","Well tolerated in the recommended dose. Occasionally a mild laxative effect may observe.
","No experience is available about the use of Silymarin 70 mg or 140 mg during pregnancy and lactation. Therefore, if needed Silymarin 70 mg or 140 mg should be taken with caution according to the physician’s advice.
",,,,,,"Store in a cool & dry place, away from light & moisture. Keep out of reach of children.
",9
+1770,Sharbat Musaffi,sharbat-musaffi-1770,,Herbal and Nutraceuticals,Syphilis,"It is a blood purifier. Prevents itch, boils, pimples, and other skin eruptions. Also useful in syphilis and gonorrhea.
","Herbal and Nutraceuticals
",,"50 ml to be mixed with water and take once in a day.
",,,,,,,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",4
+1825,Sharbat Amla,sharbat-amla-1825,,Herbal and Nutraceuticals,Vitamin C deficiency,"This syrup is indicated in Vitamin C deficiency diseases, cough, cold, general weakness, nervous debility, mental fatigue, weakness of memory, indigestion, malnutrition and leanness.
","Herbal and Nutraceuticals
",,"Adult: 2-4 teaspoonfuls 1-2 times daily after meal.
Children: 1-2 teaspoonfuls 1-2 times daily after meal. Or, as directed by the registered physician.
",,"No report is available.
","There is no evidence available in contraindication but it may happen in patients who are hypersensitive to any of its ingredient.
","No significant side effects have been observed in therapeutic dosage.
","The safety of this syrup in pregnancy has not been studied. Therefore, it should be used with caution during pregnancy.
",,,,,,"Keep out of reach of children. Store in a cool & dry place. Protect from Light.
",8
+1761,Saw palmetto (500 mg),saw-palmetto-500-mg-1761,,Herbal and Nutraceuticals,Healthy urinary flow,"This is indicated in urination problems in benign prostatic hyperplasia stages I & II.
","Herbal and Nutraceuticals
",,"1 to 2 g (2-4 capsules) in divided doses daily.
",,"It is believed to exert estrogen, androgen and alpha-adrenergic blocking effects. Because of this, the use of hormones, hormone-like drugs or adrenergic drugs concomitantly may need to be adjusted.
","No absolute contraindications.
","In rare cases stomach problems.
",,,,,,,"Store away from direct light, heat & moisture. Keep at room temperature. Do not use the drug after expiry date.
",7
+1532,Saw Palmetto (160 mg),saw-palmetto-160-mg-1532,,Herbal and Nutraceuticals,Supports normal prostate function,"An advanced blend of minerals & herbs that can help a proactive approach to prostate health. Saw palmetto supports normal prostate function and healthy urinary flow. It contains Zinc which is required for normal reproductive function.
","Herbal and Nutraceuticals
","Saw Palmetto exerts anti-estrogenic activity, increases urinary fow rate; decreases residual urine; decreases painful urination; decreases nocturia; anti-infammatory activities by following possible mechanisms:
+
+- Inhibits action of 5α-reductase, which catalyzes the metabolism of testosterone to DHT, due to the free fatty acid content of the fruit’s lipophilic extracts.
+- Inhibits receptor binding of androgens.
+- Inhibits noncompetitively human α 1-adrenoreceptors.
+- Inhibits both the cyclooxygenase and lipoxygenase pathways in vitro
+- Inhibits growth factors in vitro
+- Binds selectively to and increases apoptotic index for prostate cells
+
","For Adult use only. Usual dosage is 1-2 capsules daily or as advised by the physician.
",,"Saw palmetto might decrease the efects of estrogen in the body. Taking saw palmetto along with birth control pills might decrease the efectiveness of birth control pills.
","Saw palmetto is not indicated for advanced BPH with severe urinary retention. It should not be used without frst ruling out prostate cancer.
","Rare case of GI disturbance has been reported. Ingestion on an empty stomach may cause nausea. Hypertension was reported in 3.1% taking saw palmetto extract.
",,"Saw palmetto might slow blood clotting. There is some concern that it might cause extra bleeding during and after surgery. Stop using saw palmetto at least 2 weeks before a scheduled surgery.
","Safety and efectiveness of Saw palmetto in pediatric population have not been established.
",,,,"Store in a cool and dry place, below 30°C. Protect from light & moisture. Keep the medicine out of reach of children.
",10
+1763,Saribadyarista,saribadyarista-1763,,Herbal and Nutraceuticals,Scabies,"Saribadyarista is effective in skin diseases eg. scabies, itching, boil, pimple & dermatitis. It also improves complexion. Saribadyarista stimulates the natural process of blood purification. It helps the liver in detoxification processes and thus helps in the treatment of skin diseases.
","Herbal and Nutraceuticals
","Saribadyarista is a combination of effective herbs that has hepatoprotective, antiallergic, antifungal, anthelmintic, antibacterial, antiinflammatory and antioxidant properties.
","Adult: 2-4 teaspoonful 1-2 times daily after meal.
Children under 12 years: 1-2 teaspoonful 1-2 times daily after meal or as directed by the registered physician.
",,,"There is no absolute contraindication.
","Not yet known.
",,,,,,,"keep all medicines out of reach of children. Store in cool & dry place, protected from light.
",7
+1691,Sanoon Babla,sanoon-babla-1691,,Herbal and Nutraceuticals,Toothache,"Sanoon Babla is indicated in-
+
+- Pyorrhoea
+- Gingivitis
+- Toothache
+- Foul smell of mouth
+- Dental caries
+- Bleeding gum
+- Plaque
+- Cavities
+- Mouth ulcer
+
","Herbal and Nutraceuticals
","Sanoon Babla is a unique combination of Acacia (Acacia arabica), Catechu (Acacia catechu), Betel nut (Areca catechu), Ginger (Zingiber officinale) and other natural ingredients. It is highly effective in pyorrhea, gingivitis, toothache & foul smell of mouth.
","Take Danta Rakkha tooth powder on a soft tooth brush or on index finger and massage gently both side of teeth & gums, twice daily. Rinse thoroughly with water after the massage/brush.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper usage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1764,Sanjivani Rasayan,sanjivani-rasayan-1764,,Herbal and Nutraceuticals,General weakness,"This is indicated in Physical & mental weakness, Senile debility, Nervous exhaustion & Stress.
","Herbal and Nutraceuticals
","Sanjivani Rasayan is a combination of some effective herbs that have antioxidant, immune enhancing, rejuvenating, anxiolytic, antidepressant and nutritive properties. It is used to combat physical weakness, mental weakness, nervous exhaustion etc. It is very effective in senile debility and stress. It is used for all ages of both male & female patients.
","Adults: 2-4 teaspoonful 2-3 times daily after meal.
Children: 1-2 teaspoonful 2-3 times daily after meal or as directed by the registered physician.
",,,"There is no absolute contraindication.
","There is no significant side effect.
","Not recommended for use during pregnancy. (due to presence of Withania somnifera, Cinnamomum zeylanicum & Crocus sativus). There is no sufficient information for use in lactation.
",,,,,,,7
+1728,Sana + Revand Chini + Neem + Chirata + Tulsi,sana-revand-chini-neem-chirata-tulsi-1728,,Herbal and Nutraceuticals,Vitiligo,"This preparation is indicated for
+
+- blood impurities
+- boil
+- acne
+- pimple
+- blemishes
+- eczema
+- psoriasis
+- scabies
+- nose bleeding
+- constipation
+- obesity
+- general lassitude
+- measles &
+- burning sensation during urination.
+
","Herbal and Nutraceuticals
","The action of major ingredients of this preparation-
+
+- Sana: Keeps stomach clear and helps to prevent skin problems.
+- Revand Chini: Purifies blood, improves liver function and promotes cell repair.
+- Neem: Purifies blood and cures almost every skin disease.
+- Chirata: Purifies blood and keeps it toxin free for better skin conditioning.
+- Tulsi: Improves blood circulation and helps to improve shine on skin.
+
","Syrup:
+
+- Adults: 2-4 teaspoonfuls 1-2 time(s) daily.
+- Children: ½-1 teaspoonful 1-2 time(s) daily.
+
+Capsule: 1 capsule 2 times daily. or as prescribed by the registered physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in therapeutic dosage.
",,"During this treatment, eat slightly less than your appetite demands. Avoid fried, spiced or hard-to-digest foods. Keep out of reach of children. Don’t use the drug after expiry date.
",,,,,"Store in a cool and dry place away from light.
",8
+1714,Salep + Coconut + Poppy Seeds + Almond,salep-coconut-poppy-seeds-almond-1714,,Herbal and Nutraceuticals,Spermatogenesis induction,"This is indicated in-
+
+- General debility
+- Nervous debility
+- Sexual debility
+- Oligospermia
+- Spermatorrhoea
+
","Herbal and Nutraceuticals
","This is a unique combination of Salep (Orchis latifolia), Coconut (Cocos nucifera), Poppy Seeds (Papaver somniferum), Mastic tree (Pistacia vera), Almond (Prunus amygdalus), Walnut (Juglans regia) and other natural ingredients. It is effective in the treatment of sexual debility, nervous debility, general debility, spermatorrhoea and oligospermia. This is also enhances retentive power.
","1 teaspoonful twice daily with milk or honey or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in the therapeutic dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1729,"Salajeet [Mineral Pitch, Red Sage]",salajeet-mineral-pitch-red-sage-1729,,Herbal and Nutraceuticals,Vaginal leucorrhoea,"This is indicated in-
+
+- General debility
+- Spermatorrhoea
+- Polyuria
+- Leucorrhoea
+
","Herbal and Nutraceuticals
","Salajeet is a unique combination of Mineral Pitch (Silajit), Sage (Salvia haematodes) and others natural ingredients. It enhances the activity of insulin, which is beneficial for diabetic patients. It is effective in leucorrhoea and polyuria. Salajeet acts as a powerful antioxidant, it provides protection against degenerative diseases such as heart disease, diabetes and arthritis. It also acts general tonic and effective in spermatorrhoea.
","1 tablet twice daily or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1721,Saffron + Sand Lizard + Nutmeg fruit,saffron-sand-lizard-nutmeg-fruit-1721,,Herbal and Nutraceuticals,Premature ejaculation,"This is indicated in-
+
+- Sexual debility
+- Loss of libido
+- Premature ejaculation
+- Fatigue
+
","Herbal and Nutraceuticals
","This is a unique preparation of Saffron (Crocus sativus), Nutmeg (Myristica fragrans) and other natural ingredients. It is a tonic to increase libido, helps retentive power, and maintains youthful vigour & vitality. It is effective in sexual debility, premature ejaculation and fatigue.
","1-2 tablet(s) to be taken with milk 2 hours before coitus or as prescribed by the physician.
",,,"It is contraindicated for children.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place protect from light.
",8
+126,Betamethasone + Calcipotriol,betamethasone-calcipotriol-126,https://medex.com.bd/attachments/JbrekhKIpbpEaaDH2pZZktWilV14hn/betamethasone-calcipotriol-00050064-for-topical-use-prescribing-information,Betamethasone & Combined preparations,Scalp psoriasis,"
+- This Ointment is indicated for the topical treatment of plaque-type psoriasis vulgaris amenable to topical therapy.
+- This Topical Suspension is indicated for the topical treatment of plaque psoriasis of the scalp and body.
+
","Betamethasone & Combined preparations
","Betamethasone Dipropionate is a potent topically-active corticosteroid producing prompt, marked and prolonged anti-inflammatory, antipruritic, vasoconstrictive and immunosuppressive properties, without curing the underlying condition. These effects can be enhanced under occlusive conditions due to increased penetration of stratum corneum (by approximately a factor of 10).
Calcipotriol is a non-steroidal antipsoriatic agent, derived from vitamin D. Calcipotriol exhibits a vitamin D-like effect by competing for the 1,25(OH)2D3 receptor. Calcipotriol is as potent as 1,25(OH)2D3, the naturally occurring active form of vitamin D, in regulating cell proliferation and cell differentiation, but much less active than 1,25(OH)2D3 in its effect on calcium metabolism. Calcipotriol induces differentiation and suppresses proliferation (without any evidence of a cytotoxic effect) of keratinocytes, thus reversing the abnormal keratinocyte changes in psoriasis. The therapeutic goal envisaged with Calcipotriol is thus a normalization of epidermal growth.
","Ointment: This Ointment is indicated for topical use only. The phototoxic effects have not been studied in psoriasis patients. All psoriasis-affected areas treated with this Ointment should be, where possible, protected from direct sunlight and UV-light with items of clothing.
+
+- Adults: This ointment should be applied topically to the affected area once daily. The maximum daily dose should not exceed 15 gm. The maximum recommended weekly dose of ointment is 100 gm/week. The treated area should not be more than 30% of the body surface. The use of this ointment should be intermittent for up to one year under close medical supervision. Treatment should be limited to four week periods with Calcipotriol used alone for one month between periods of use of this ointment as needed.
+- Children: This ointment is not recommended for use in children and adolescents below the age of 18 years.
+
+
Topical Suspension: Apply required quantity of spray of Topical Suspension once daily to the affected areas and gently rub in using the tips of the fingers. Treatment may be continued for up to 8 weeks. Treatment may be discontinued earlier, if symptoms are cleared. The maximum weekly dose should not exceed 100 gm. Shake before use. This Topical Suspension is not for oral, ophthalmic or intravaginal use.
",,"Additive adverse effects when used with other steroids.
","Betamethasone and Calcipotriol containing preparation is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. It is also contraindicated in patients with known disorders of calcium metabolism. Patients with severe renal insufficiency or severe hepatic disorders are also contraindicated.
","The most common adverse reactions are folliculitis and burning sensation of skin.
","There are no adequate and well-controlled studies in pregnant women. Ointment or suspension should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topically administered calcipotriene or corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Calcipotriol and Betamethasone ointment or suspension is administered to a nursing woman.
","Hypercalcemia and hypercalciuria have been reported. If either occurs, discontinue until parameters of calcium metabolism normalize. Topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome and unmask latent diabetes. Rate of adrenal suppression increased with treatment duration. Systemic absorption may require evaluation for HPA axis suppression. Modify use if HPA axis suppression develops. Potent corticosteroids, use on large areas, prolonged use or occlusive use may increase systemic absorption. Local adverse reactions may include atrophy, striae, irritation, acne form eruptions, hypopigmentation, and allergic contact dermatitis and may be more likely with occlusive use or more potent corticosteroids. Use is not recommended on face, axillae, groin or where atrophy is present. Children may be more susceptible to systemic toxicity when treated with topical corticosteroids.
",,,,,"Store in a cool (below 25ºC) & dry place & protect from light. Do not refrigerate. Keep out of the reach of children.
",10
+1617,Betamethasone,betamethasone-1617,https://medex.com.bd/attachments/q5xdFaXrDMNB5liJsN0JMlcuAd7SZg/betamethasone-prescribing-information,Corticosteroid,Rheumatoid arthritis,"Betamethasone Soluble Tablets belong to a group of medicines called steroids. Their full name is corticosteroids. These corticosteroids occur naturally in the body and help to maintain health and well being. Boosting your body with extra corticosteroids (such as Betamethasone Soluble Tablets) is an ... Read more
Betamethasone Soluble Tablets belong to a group of medicines called steroids. Their full name is corticosteroids. These corticosteroids occur naturally in the body and help to maintain health and well being. Boosting your body with extra corticosteroids (such as Betamethasone Soluble Tablets) is an effective way to treat various illnesses involving inflammation in the body. Betamethasone Soluble Tablets reduce this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it. Many different conditions can be improved by the use of corticosteroids, as they reduce inflammation (redness, tenderness, heat and swelling) in the body. Betamethasone Soluble Tablets are used to treat:
+
+- Asthma
+- Severe allergic reactions
+- Rheumatoid arthritis
+- Autoimmune diseases such as systemic lupus erythematosus (SLE) and polyarteritis nodosa; inflammatory conditions of the skin, kidney (such as acute interstitial nephritis or minimal change nephrotic syndrome), bowels (such as ulcerative colitis and Crohn’s disease) and heart
+- Some connective tissue diseases
+- Certain conditions of the blood
+- Some types of cancer, such as malignant lymphoma
+- Corticosteroids are also used to help prevent organ transplant rejection following organ transplant surgery.
+
","Corticosteroid
","Corticosteroids bind to the glucocorticoid receptor, inhibiting pro-inflammatory signals, and promoting anti-inflammatory signals. Betamethasone phosphate has a short duration of action as it is rapidly hydrolyzed to betamethasone. Corticosteroids have a wide therapeutic window as patients may require doses that are multiples of what the body naturally produces. Patients taking corticosteroids should be counselled regarding the risk of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections.
","Short term treatment:
+
+- 2000-3000 mcg (4-6 tablets) daily for the first few days, then
+- Your doctor may reduce the daily dose by 250-500 mcg (1/2 or 1 tablet) every two to five days, depending upon the response.
+
+Rheumatoid arthritis:
+
+- 500-2000 mcg (1-4 tablets) daily
+- For long-term treatment the dose may be lower.
+
+Most other conditions:
+
+- 1500-5000 mcg (3-10 tablets) daily for one to three weeks
+- Your doctor may then gradually reduce this to a lower dose
+- Larger doses may be needed for mixed connective tissue diseases and ulcerative colitis
+- If you need to take half a tablet you should break one in half. Use the break line on one side of the tablet to help you snap it.
+
",,,"Do not take Betamethasone Soluble Tablets:
+
+- if you are allergic to betamethasone or any of the other ingredients of this medicine
+- if you have an infection and have not yet started taking medicine (e.g. antibiotics) to treat it.
+
","Feeling depressed, including thinking about suicide; Feeling high (mania) or moods that go up and down; Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory; Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.
","If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Taking steroids often or for a long time during pregnancy can slow the baby’s growth in the womb or may temporarily affect the baby’s heart and body movements. If you are breast-feeding, the steroid may enter the baby and lower their hormone levels, if you are taking high doses for a long time.
","Talk to your doctor, pharmacist or nurse before taking Betamethasone Soluble Tablets-
+
+- if you have ever had severe depression or manic depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Betamethasone Soluble Tablets;
+- if any of your close family has had these illnesses;
+- if you have or have ever had tuberculosis (TB);
+- if you have epilepsy (fits), severe mental illness, heart disease, hypertension (high blood pressure), stomach or duodenal ulcers;
+- if you have osteoporosis (thinning of the bones). Post menopausal women are particularly at risk of this;
+- if you or any of your family have ever had glaucoma (raised eye pressure);
+- if you have recently had a heart attack;
+- if you have recently been in contact with someone who has chickenpox, shingles or measles or recently had chickenpox, shingles or measles yourself. This product may make chickenpox, shingles or measles much worse;
+- if you or any of your family are diabetic;
+- if you have an underactive thyroid gland;
+- if you have myasthenia gravis (a disease which causes muscle weakness);
+- if you have ever suffered from muscle wasting due to corticosteroids;
+- if you have liver, kidney or heart disease;
+- if you have just been or are about to be immunised;
+- if you have an infection;
+- if you are pregnant or breast-feeding
+- if you experience blurred vision or other visual disturbances.
+
",,,,,"Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Do not store above 25ºC.
",9
+122,Betahistine Mesylate,betahistine-mesylate-122,,Drugs used in meniere's diseases,Vertigo,"Betahistine Mesylate is indicated in vertigo and dizziness associated with the following diseases: Meniere's disease, Meniere's syndrome, Peripheral vertigo.
","Drugs used in meniere's diseases
","Betahistine Mesilate dilates precapillary sphincters, increasing the blood flow in the inner ear. It controls the permeability of capillaries in the inner ear, thereby removing endolymphatic hydrops. It also improves cerebral circulation, increasing blood flow in the internal carotid artery. Thus, Betahistine Mesylate is clinically useful for the relief of vertigo and dizziness.
Betahistine Mesilate increases microcirculation blood flow in the inner ear, and removes endolymphatic hydrops of the inner ear. It also significantly increases the blood flow of the internal carotid artery.
For discomfort accompanying cerebral disturbances: Betahistine exhibits a marked healing effect on giddiness experienced upon standing, the sensation of instability, and symptoms of dizziness. The heavy feeling in the head and the accompanying discomforts can also be successfully subdued.
For dizziness and the sensation of dizziness due to disturbances in the inner ear: Betahistine improves microcirculation of the inner ear and removes endolymph hydrops, thereby alleviating dizziness in Meniere's disease and Meniere's syndrome. Tinnitus, the sensation of ear obstructions, nausea and vomiting are also effectively allayed. For the prevention of dizzy spells and other residual symptoms: Along with inhibiting the symptoms of dizziness and removing residual symptoms after the attack, continued administration of Betahistine Mesylate also prevents the recurrence of dizzy spells.
As the primary in prescribing for dizziness: By the combined use with antihypertensive agents, therapeutic agents for arteriosclerosis, vitamins and tranquilizers, accompanying symptoms can also be brought into remission and better therapeutic effects obtained.
","Usually, for adults, administer orally 1 to 2 tablets three times per day after meals. The dose may be adjusted according to the age of patient and severity of symptoms.
",,,"Hypersensitivity to betahistine mesylate, pheochromocytoma, peptic ulcer, acute bronchial asthma.
","Digestive: Nausea or vomiting may rarely occur. Hypersensitivity: Hypersensitivity reactions, such as skin rash, may rarely occur.
","Safety of Betahistine during pregnancy has not been established. This drug should be administered to pregnant patients or women suspected of being pregnant, only if the expected therapeutic benefit is thought to outweigh any possible risk.
","Patients with a history of digestive ulcer or an active digestive ulcer, Patients with bronchial asthma, Patients with pheochromocytoma.
",,,,,"Store in cool and dry place. Protect from light & moisture.
",9
+121,Betahistine Dihydrochloride,betahistine-dihydrochloride-121,https://medex.com.bd/attachments/mEP2SiSXFEnPTpy1L5kLZLzbu1qBNo/betahistine-dihydrochloride-prescribing-information,Drugs used in meniere's diseases,Vertigo,"Meniere's disease and Meniere-like syndromes are characterized by attacks of vertigo, tinnitus and/or progressive loss of hearing, usually accompanied by nausea and vomiting.
","Drugs used in meniere's diseases
","The mechanism of action of betahistine is multifactorial. Meniere's disease is thought to result from a disruption of endolymphatic fluid homeostasis in the ear. Betahistine mainly acts as a histamine H1-receptor agonist. The stimulation of H1-receptors in the inner ear causes a vasodilatory effect leading to increased permeability of blood vessels and a reduction in endolymphatic pressure; this action prevents the rupture of the labyrinth, which can contribute to the hearing loss associated with Ménière's disease. Betahistine is also purported to act by reducing the asymmetrical functioning of sensory vestibular organs and increasing vestibulocochlear blood flow, relieving symptoms of vertigo.
In addition to the above mechanisms, betahistine also acts as a histamine H3-receptor antagonist, increasing the turnover of histamine from postsynaptic histaminergic nerve receptors, subsequently leading to an increase in H1-agonist activity. H3-receptor antagonism elevates levels of neurotransmitters including serotonin in the brainstem, inhibiting the activity of vestibular nuclei, thus restoring proper balance and decreasing vertigo symptoms.
","The usual initial dose: 8 mg to 16 mg three times daily taken preferably with meals.
Maintenance dose: Up to 48 mg daily has been recommended. Betahistine is not recommended for use in children.
",,"There are no proven cases of hazardous interactions. Though an antagonism between Betahistine and antihistamines could be expected on a theoretical basis, no such interactions have been reported.
","Betahistine is contraindicated in pheochromocytoma.
","Betahistine is generally well tolerated and there is no known serious adverse effects. In some circumstances gastrointestinal disturbances, headache, rashes and pruritus have been reported.
","In Pregnancy: The safety of Betahistine in human pregnancy has not been completely established, although there is no known teratogenic effect in animals. A careful assessment of potential benefits should be made before prescribing Betahistine in pregnancy.
In Lactation: Betahistine is excreted in the breast milk of nursing mothers in concentrations similar to those found in plasma. Toxicity to the neonate at these concentrations is not known.
","Caution should be exercised in patients with bronchial asthma and peptic ulceration.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+120,Betacarotene + Vitamin C + Vitamin E,betacarotene-vitamin-c-vitamin-e-120,,Anti-oxidant Multivitamin preparations,Vitamin deficiency,"Antioxidant vitamins are used in a wide range of conditions where free radical damage is playing a role. Antioxidant vitamin combination is used in the prevention of coronary heart diseases, certain types of cancer, aging as well as free radical damage caused by excessive exercise, illness, certain ... Read more
Antioxidant vitamins are used in a wide range of conditions where free radical damage is playing a role. Antioxidant vitamin combination is used in the prevention of coronary heart diseases, certain types of cancer, aging as well as free radical damage caused by excessive exercise, illness, certain medications, air pollution, smoke, radiation and pesticides. The main role of the antioxidant vitamins is as follows:
β carotene prevents free radical formation by quenching singlet oxygen, a highly reactive form of oxygen. Vitamin C is another free radical scavenger which deactivates free radicals. It works specially in the plasma, lung fluid, aqueous humour and interstitial fluid. It can increase white blood cell activity; play important roles in the biochemistry of antibodies, prostaglandin E 1 , B and T lymphocytes, and interferon. Vitamin E also scavenges free radicals in the blood along with β carotene and vitamin C. Moreover, vitamin E is essential to protect against some of the ill effects of smog and smoke. In relation to other nutrients vitamin E protects vitamin A from being destroyed in the body.
","Anti-oxidant Multivitamin preparations
","Beta carotene of this tablet is converted to vitamin A (Retinol) when required. Retinol has several biochemical functions e.g. on retina, growth, tissue differentiation, immunological response. It has also some anti-cancer activity.
Vitamin C is the most powerful reducing agent known to be present in living tissues. Vitamin C deficiency produces scurvy. It is a cofactor in numerous biological processes. Vitamin C and molecular oxygen are essential for the conversion of proline to hydroxyproline, dopamine to noradrenaline . Vitamin C is also essential for the synthesis of adrenal steroid hormones. Vitamin C is important in the defense against infection and studies shown that vitamin C is important for the normal functioning of T-lymphocyte and leukocyte. Ascorbic acid has some antiinflammatory activity and protects cells against oxidation of essential molecules. In high doses, (1-2 g daily) ascorbic acid increases iron absorption.
vitamin E seems to be as a defense against oxidative stress and lipid peroxidation. In most cell membranes there is one molecule of tocopherol for every 1000 lipid molecules. Tocopherol mops up peroxide radicals and then needs a supply of reduced hydrogen to restore the steady-state situation. This is usually supplied by ascorbic acid or reduced glutathione.
","This tablet is administered orally. The adult dose of this combination of antioxidant vitamin tablet is 1 tablet daily or as prescribed by the physician.
",,"Cholestyramine, Colestipol, Neomycin cause decreased absorption of β carotene. Circulating vitamin C levels have been shown to be reduced during prolonged administration of oral contraceptives containing Oestrogen, Tetracycline and Aspirin. The decrease in vitamin C level may be due to drug induced impaired absorption or increased utilization of the vitamin for drug metabolism. Vitamin E may enhance the anticoagulant activity of anticoagulant drugs. High doses of vitamin E can impair intestinal absorption of vitamins A and K.
","Carocet is contraindicated in patients with hypersensitivity to any of its components.
","β carotene is comparatively safe even at high and prolonged exposure. Individuals who routinely ingest large amounts of carotenoids can develop hypercarotenosis, which is characterised by a yellowish colouration of the skin and a very high concentration of carotenoids in the plasma. This benign condition, although resembling jaundice, gradually disappears upon correcting the excessive intake of carotenoids.
Vitamin C is generally a safe drug for human use in normal doses. Larger doses may lead to gastrointestinal tract upset and renal stone formation.
Vitamin E is considered safe even in large doses. Doses over 800 mg may cause diarrhoea, abdominal pain or cramps, fatigue and reduced resistance to bacterial infection and transiently raised blood pressure.
","β carotene, vitamin C and vitamin E have no teratogenic effects in humans. However, like any other drugs caution should be taken in prescribing to pregnant women.
","There are some evidences that β carotene may cause harm to heavy smokers and alcoholics. Therefore, caution should be exercised in these cases. Vitamin C should be given with caution to patients with hyperoxaluria. Vitamin E should be used with caution in patients taking anticoagulant drugs, because vitamin E may enhance the anticoagulant activity of these drugs.
",,,,,"Should be stored in a dry place below 30˚C.
",10
+119,Besifloxacin,besifloxacin-119,https://medex.com.bd/attachments/Fjg0mFlgsfZMpWOVufHXB5kLb3y6z7/besifloxacin-prescribing-information,Ophthalmic antibacterial drugs,Inflammation of the cornea,"Besifloxacin ophthalmic suspension is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria:
+
+- Corynebacterium pseudodiphtheriticum
+- Corynebacterium striatum
+- Haemophilus influenzae
+- Moraxella lacunata
+- Staphylococcus aureus
... Read more
Besifloxacin ophthalmic suspension is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria:
+
+- Corynebacterium pseudodiphtheriticum
+- Corynebacterium striatum
+- Haemophilus influenzae
+- Moraxella lacunata
+- Staphylococcus aureus
+- Staphylococcus epidermidis
+- Staphylococcus hominis
+- Staphylococcus lugdunensis
+- Streptococcus mitis group
+- Streptococcus oralis
+- Streptococcus pneumoniae
+- Streptococcus salivarius
+
+Efficacy for this organism was studied in fewer than 10 infections.
","Ophthalmic antibacterial drugs
","Besifloxacin acts against Gram positive and Gram negative bacteria due to the inhibition of both bacterial DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme required for replication, transcription and repair of bacterial DNA. Topoisomerase IV is an essential enzyme required for partitioning of the chromosomal DNA during bacterial cell division.
","Adults and children (1 year of age and older): Instill one drop in the affected eye(s) 3 times a day for 7 days.
Pediatric Use: The safety and effectiveness of Besifloxacin in infants below one year of age have not been established.
",,"No such information found. Topical ophthalmic use only
","Hypersensitivity to the active ingredient or any component of this formulation.
","The most frequently reported ocular adverse event was conjunctival redness, reported in approximately 2% of patients. Other adverse events reported in patients receiving Besifloxacin occurring in approximately 1-2% of patients included: blurred vision, eye pain, eye irritation, eye pruritus and headache.
","Pregnancy Category C. No adequate and well-controlled studies are established in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is not known whether Besifloxacin is secreted in human milk or not. Caution should be exercised when Besifloxacin is administered to a nursing mother.
","This drug is for topical ophthalmic use only and should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. To prevent contamination do not touch the tip of the dropper to eye, eyelid or any surface of the affected eye. Patients should not wear contact lenses during the course of therapy with this drug. Shake well before use.
",,"No data are available regarding the over dose of Besifloxacin.
",,,"Store in a cool, dry place and protected from light. Keep out of the reach of children. Discard the container 4 weeks after opening.
",11
+118,Bepotastine Besilate,bepotastine-besilate-118,https://medex.com.bd/attachments/DhLDDurtSdNwi3yguXiBKxkvAvhib6/bepotastine-besilate-prescribing-information,Ophthalmic Anti-allergic preparations,Conjunctivitis,"Bepotastine Besilate is indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.
","Ophthalmic Anti-allergic preparations
","Bepotastine is direct H1-receptor antagonist and an inhibitor of the release of histamine from mast cells.
","The recommended dose is 1 drop into the affected eye(s) twice a day. Safety and effectiveness in children below the age of 2 years have not been established.
",,"No drug interactions observed but patients who are sensitive to this product molecule should be used with caution.
","Contraindicated in patients with a history of hypersensitivity reactions to Bepotastine Besilate or any of the other ingredients of this product.
","The most common reported side effect occurring in approximately 25% of subjects was a mild taste following instillation. Other side effects occurring in 2-5% of subjects were eye irritation, headache, and nasopharyngitis.
","Pregnancy Category C. There are no adequate and well controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
Lactation: It is not known if Bepotastine Besilate is excreted in human milk. Caution should be exercised when it is administered to a nursing woman.
","To minimize the risk of contamination, do not touch dropper tip to any surface. It should not be used to treat contact lens-related irritation. Patients should be advised not to wear contact lens when using this drop.
",,"If you use more Bepotastine Besilate eye drops than you should, rinse your eye with warm water. Do not put in any more drops until it is time for your next regular dose. Pharmaceutical Precautions
",,,"Store in a cool, dry place & protected from light. Keep out of reach of children. Do not use more than 4 weeks after opening.
",11
+116,Benzyl Penicillin,benzyl-penicillin-116,https://medex.com.bd/attachments/5RGzrBrPNUrllXLiY9lNeFMliAEfiN/benzyl-penicillin-revised-september-2016-prescribing-information,Benzylpenicillin & Phenoxymethyl penicillin,Syphilis,"For use in the treatment of severe infections caused by penicillin G-susceptible microorganisms when rapid and high penicillin levels are required such as in the treatment of septicemia, meningitis, pericarditis, endocarditis and severe pneumonia.
","Benzylpenicillin & Phenoxymethyl penicillin
","Benzylpenicillin has a bactericidal action against gram positive bacteria, gram negative cocci, some other gram negative cross-linking stage of peptidoglycan production through binding and inactivation of transpeptidases on the inner surface of the bacterial cell membrane thus inhibiting bacterial cell wall synthesis. It is inhibited by penicillinase and other β-lactamases.
","Adult:
Oral: Susceptible infections: 125-312 mg 4-6 hrly.
IM/IV: Susceptible infections: 0.6-3.6 g/day in 4-6 divided doses.
IV:
+
+- Bacterial endocarditis: 7.2-12 g/day in divided doses.
+- Intrapartum prophylaxis against group B Streptoccocal infection in neonates Initial: 3 g, followed by 1.5 g 4 hrly until delivery.
+- Meningococcal meningitis; Pneumococcal meningitis: 2.4 g 4 hrly. Max: 18 g/day in meningococcal meningitis.
+
+
Child:IV: Meningococcal meningitis, Pneumococcal meningitis:
+
+- Newborn infants: 100 mg/kg daily in 2 divided doses;
+- 1-4 wk: 150 mg/kg daily in 3 divided doses;
+- >1 mth to 12 yr: 180-300 mg/kg daily in 4-6 divided doses.
+
+
Parenteral: susceptible infections:
+
+- Newborn infants: 50 mg/kg daily in 2 divided doses;
+- 1-4 wk: 75 mg/kg daily in 3 divided doses;
+- >1 mth to 12 yr: 100 mg/kg daily in divided doses, not exceeding 4 g/day.
+
","Should be taken on an empty stomach. Take with a full glass of water on an empty stomach 1 hr before or 2 hr after meals. Do not take acidic beverages within 1 hr of a dose.
","May increase the risk of methotrexate toxicity. Increased plasma concentration with probenecid. Antagonism of bactericidal effect with bacteriostatic antibacterials (e.g. erythromycin, tetracyclines).
","Hypersensitivity to benzylpenicillin and other penicillins.
","Nausea, vomiting, stomatitis, black or hairy tongue, rash, fever, serum-like sickness, convulsions, interstitial nephritis, haemolytic anaemia, granulocytopenia, agranulocytosis, leucopenia, thrombocytopenia
","Pregnancy category B. Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect that was not confirmed in controlled studies in women in the 1st trimester.
Lactation: Monitor electrolyte, hepatic, renal, cardiac and haematologic function; signs and symptoms of anaphylaxis during 1st dose.
","Patient with history of allergy esp β-lactam allergy and/or asthma, seizure disorder. Diabetic patients. Renal impairment. Pregnancy and lactation.
",,"Symptoms: Agitation, confusion, asterixis, hallucinations, stupor, coma, multifocal myoclonus, seizures and encephalopathy, hyperkalaemia.
Management: Symptomatic and supportive treatment.
",,"Loosen the powder, then, hold the vial horizontally and rotate it while slowly directing the stream of diluent against the wall of the vial. Shake the vial vigorously after all the diluent has been added. Depending on the route of admin, reconstitute with sterile water for inj, NaCl 0.9% inj or dextrose 5% inj.
","Store between 20-25°C. Reconstituted soln: Store between 2-8°C.
",13
+115,Benzyl Benzoate,benzyl-benzoate-115,https://medex.com.bd/attachments/U8HyBj4S3fXADZH0Gqj0sa2ENAGvx5/benzyl-benzoate-prescribing-information,Parasiticidal preparations,Scabies,"Benzyl Benzoate is indicated for scabies
","Parasiticidal preparations, Topical Antifungal preparations
","Benzyl benzoate is an acaricide that is used in the treatment of scabies. Benzyl benzoate exerts toxic effects on the nervous system of the parasite, resulting in its death. It is also toxic to mite ova, though its exact mechanism of action is unknown. In vitro, benzyl benzoate has been found to kill the Sarcoptes mite within 5 minutes.
","Adult: Apply 3 times at 12 hourly intervals over the whole body, wash-off 12 hr after the last application.
",,"Irritant to eyes and mucous membranes, allergic dermatitis reactions, drying effects in the elderly.
","Broken or irritated skin; neonates; pregnancy.
","Irritant to eyes and mucous membranes, allergic dermatitis reactions, drying effects in the elderly.
","Pregnancy Category: Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
","Prevent drug from entering the eyes, elderly (drying effects).
",,,,,"Store below 25°C.
",10
+1276,Benzyl Alcohol,benzyl-alcohol-1276,https://medex.com.bd/attachments/eZzGr5WyWFfkOoC3ZQBIbFnAR7O4kU/benzyl-alcohol-injection-prescribing-information,Other scalp preparations,Pediculosis capitis,"Benzyl alcohol lotion is indicated for the topical treatment of head lice infestation in patients 6 months of age and older. Benzyl alcohol Lotion does not have ovicidal activity.
","Other scalp preparations
","Benzyl alcohol inhibits lice from closing their respiratory spiracles, allowing the vehicle to obstruct the spiracles and causing the lice to asphyxiate.
","Adult:
Apply lotion to dry hair, using enough to completely saturate hair & scalp, rinse off with water after 10 minutes. Repeat treatment in 7 days
Amount of Lotion Needed to Cover Scalp and Hair Completely
+
+- Hair length 0-2 inches: 4-6 ounces
+- Hair length 2-4 inches: 6-8 ounces
+- Hair length 4-8 inches: 8-12 ounces
+- Hair length 8-16 inches: 12-24 ounces
+- Hair length 16-22 inches: 24-32 ounces
+- Hair length >22 inches: 32-48 ounces
+
+
Child:
+
+- <6 months: Do not use
+- >6 months: Apply lotion to dry hair, using enough to completely saturate hair & scalp, rinse off with water after 10 minutes; repeat treatment in 7 days
+
",,"No formal drug interaction studies to date.
","Hypersensitivity to any of the active ingredients.
","Generally well tolerated. However, a few allergic reactions may be seen. Irritation, itching, redness, tingling, or numbness at the application site may occur. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
","Pregnancy Category B. Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
Lactation: Excretion in milk unknown; use with caution
","Constant or forceful scratching of the skin/scalp may lead to a bacterial skin infection.
",,,,,,9
+1432,Benzydamine Hydrochloride,benzydamine-hydrochloride-1432,https://medex.com.bd/attachments/N4VnNMRWxFJH8K5xFsMhYtzPZUsPCA/benzydamine-hydrochloride-prescribing-information,Topical anti-inflammatory preparations,Sore throat,"Benzydamine Hydrochloride mouthwash is used to treat many painful conditions affecting the throat or mouth including: Sore throat, Sore tongue or gums, Mouth ulcers, Discomfort caused by dentures, Pain after dental surgery etc.
","Topical anti-inflammatory preparations
","Benzydamine Hydrochloride mouthwash is a Non-Steroidal Anti-Inflammatory Drug (NSAID) with analgesic and local anesthetic properties. The clinical pharmacology of Benzydamine mouthwash is well known. Benzydamine is poorly absorbed in the blood, thereby limiting systemic exposure to the drug when applied topically but ensures high concentration at the site of injury in mouth or throat. Therefore, it provides excellent oropharyngeal pain relief with minimal side effects.
Although Benzydamine is a Non-Steroidal Anti-Inflammatory agent, it possesses a different mechanism of action that distinguishes it from conventional NSAIDs. Benzydamine mouthwash shows analgesic & anti-inflammatory action by inhibiting pro-inflammatory cytokines & reducing vascular permeability. Moreover, Benzydamine mouthwash shows local anesthetic property which provides an immediate effect on pain.
","15 ml of Benzydamine mouthwash should be rinsed or gargled every 1.5-3 hours or as required, for 20-30 seconds. If stinging occurs, it can be diluted with an equal volume of water.
",,,"Patients allergic (hypersensitive) to Benzydamine or other component of mouthwash should not use the preparation. Contact with eye should be avoided. If accidentally get into eyes, they should be immediately washed with cold water.
","Benzydamine Hydrochloride mouthwash can cause side effects, although not everybody gets them. Side effects are generally minor.
+
+- Severe allergic reaction which may include a red and lumpy skin rash, difficulty breathing, swelling of face, mouth, lips or eyelids, unexplained high temperature (fever) and feeling faint. If the swelling affects throat and makes breathing difficult and swallowing difficult, patients should be hospitalized
+- Itchy rash, sometimes with pale, raised areas of skin with red edges (urticaria).
+- A feeling of numbness in mouth.
+- A stinging feeling in mouth- the mouthwash may be diluted with water if you experience stinging. This should help to reduce the stinging effect.
+
","The safety of Benzydamine has not been established in pregnant patients. Risk to benefit ratio should be established if this drug is to be used in these patients.
",,,,,,"Keep away from light, store in cool and dry place under 30º C. Keep out of reach of children.
",8
+114,Benzoyl Peroxide,benzoyl-peroxide-114,https://medex.com.bd/attachments/hW9jkB4Ufq0jg63uQ4U4glyeL7iwM8/benzoyl-peroxide-prescribing-information,Acne treatment preparations,Teeth whitening,"Topical therapy for the treatment of acne vulgaris.
","Acne treatment preparations
","Benzoyl peroxide has mild keratolytic effect and antimicrobial activity due to release of free-radical oxygen which oxidizes bacterial protein. It is active against Staphylococcus epidermidis and Propionibacterium acnes.
","Adult: As 2.5-10% preparation: Apply 1-2 times daily after cleansing, may gradually increase to tid if needed. Start with lower strength preparations. As cleanser: Wash 1-2 times daily.
Child: ≥12 yr Same as adult dose.
",,"There is no known interaction with other medications which might be used cutaneously and concurrently with Benzoyl Peroxide; however, drugs with desquamative, irritant and drying effects should not be used concurrently with Benzoyl Peroxide gel.
","Benzoyl Peroxide gel is contra-indicated in patients with known hypersensitivity to Benzoyl Peroxide.
","The major adverse reaction reported to date with Benzoyl Peroxide cutaneous therapy is irritation of the skin including erythema, burning, peeling, dryness, itching, stinging, feeling of skin tension locally at the site of application. This is reversible when treatment is reduced in frequency or discontinued. Allergic contact dermatitis, including face oedema, may occur.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
","Children, Pregnancy and lactation.
",,"Benzoyl Peroxide gel is a preparation indicated for topical treatment only. If the medication is applied excessively, no more rapid or better results will be obtained and severe irritation might develop. In this event, treatment must be discontinued and appropriate symptomatic therapy should be instituted.
",,,"Store in a cool and dry place, protected from light.
",11
+113,Benzoic Acid + Salicylic Acid,benzoic-acid-salicylic-acid-113,https://medex.com.bd/attachments/jrqjAKHhuWeQ3dPDbGzF9idwJeZQer/benzoic-acid-salicylic-acid-prescribing-information,Other Antifungal preparations,Fungal infections,"Benzoic Acid & Salicylic Acid is indicated for fungal infections, athlete's foot, barber's itch.
","Other Antifungal preparations
","Benzoic acid: Elicits weak antifungal and antibacterial properties; also helps acidify urine.
Salicylic acid: It has a potent keratolytic action and a slight antiseptic action when applied topically. It softens and destroys the stratum corneum by increasing endogenous hydration which causes the horny layer of the skin to swell, soften, and then desquamate. At high concentrations, salicylic acid has a caustic effect. It also possesses weak antifungal and antibacterial activity.
","Apply locally on the affected area 2-3 times per day.
",,"It is not known if this interacts with other topical medications applied to the treatment area. The use of this drug with other topical drugs has not been studied.
","Hypersensitivity.
","Irritation, sensitivity, excessive drying; systemic effects on prolonged use.
","Pregnancy Category-C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","Not for prolonged use in high concentrations and on large areas of the body. Avoid broken skin, mouth, eyes, mucous membranes and anogenital region.
",,,,,,9
+1254,Benzocaine + Camphor + Methanol + Phenol,benzocaine-camphor-methanol-phenol-1254,,Topical Local Anesthetics,Toothache,"This is indicated in sore throat, toothaches, gum pain, canker sores
","Topical Local Anesthetics
","Benzocaine binds to sodium channels and reversibly stabilizes the neuronal membrane which decreases its permeability to sodium ions. Depolarization of the neuronal membrane is inhibited thereby blocking the initiation and conduction of nerve impulses.
Camphor is a naturally occurring compound that is used as a major active ingredient of balms and liniments supplied as topical analgesics. Despite its long history of common medical use, the underlying molecular mechanism of camphor action is not understood.
Menthol is topically applied agents widely used for similar purposes, are known to excite and desensitize sensory nerves by acting on two members of transient receptor potential (TRP) channel superfamily: heat-sensitive TRP vanilloid subtype 1 (TRPV1) and cold-sensitive TRP channel M8, respectively.
Phenol is a potent proteolytic agent. Concentrations in the 5% to 7% range dissolve tissue on contact via proteolysis. In high concentrations when injected next to a nerve, phenol produces a chemical neurolysis which is nonselective across nerve fiber size and most prominent on its outer aspect. Local anesthetic effects occur within 5-10 minutes.
","Adults: apply to the affected area not more than 3 to 4 times daily
Children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily.
Children under 12 years of age: adult supervision should be given in the use of this product
",,"There are no known drug interactions and none well documented.
","Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other ""caine"" anesthetics.
","Benzocaine are more likely to cause contact sensitization. Slight burning, tingling, or stinging may occur.
","Pregnancy Category: Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
","Do not use over deep or puncture wounds, infections, or lacerations. Do not use for more than 7 days. When using this product avoid contact with the eyes, do not exceed recommended dosage. Keep out of reach of children.
",,,,,,9
+1470,Benzocaine + Butamben + Tetracaine Hydrochloride,benzocaine-butamben-tetracaine-hydrochloride-1470,https://medex.com.bd/attachments/pZ3N4WxroB54ehbIVgPWWQb7YpkMO1/benzocaine-butamben-tetracaine-hydrochloride-prescribing-information,Topical Local Anesthetics,Topical anesthesia,"This is a topical anesthetic indicated for the production of anesthesia of all accessible mucous membrane except the eyes. This reparation is indicated to control pain and for use for surgical or endoscopic or other procedures in the ear, nose, mouth, pharynx, larynx, trachea, bronchi and esophagus. It may also be used for vaginal or rectal procedures when feasible.
","Topical Local Anesthetics
","The onset of this topical gel-produced anesthesia is rapid (approximately 30 seconds) and the duration of anesthesia is typically 30-60 minutes, when used as directed. This effect is due to the rapid onset, but short duration of action of Benzocaine coupled with the slow onset, but extended duration of Tetracaine HCI and bridged by the intermediate action of Butamben. It is believed that all of these agents act by reversibly blocking nerve conduction. Speed and duration of action is determined by the ability of the agent to be absorbed by the mucous membrane. It will be excreted in the urine after metabolism.
","Dispense and apply 200 mg of gel (a bead approximately ¼ to ½ inches long) by gently squeezing the tube. Application of gel in excess of 400 mg is contraindicated. Spread thinly and evenly over the desired area using a cotton swab. An appropriate pediatric dosage has not been established for this topical gel. Dosages should be reduced in the debilitated elderly, acutely ill, and very young patients Tissue need not be dried prior to application of this topical gel. It should be applied directly to the site where pain control is required. Anesthesia is produced within one minute with an approximate duration of thirty minutes.
Pediatric Use: Safety and effectiveness of this gel in pediatric patients have not been established.
",,,"This topical gel is not suitable and should never be used for injection. Do not use on the eyes. To avoid excessive systemic absorption, this topical gel should not be applied to large areas of denuded or inflamed tissue. This topical gel should not be administered to patients who are hypersensitive to any of its ingredients or to patients known to have cholinesterase deficiencies. Tolerance may vary with the status of the patient. This topical gel should not be used under dentures or cotton rolls, as retention of the active ingredients under a denture or cotton roll could possibly cause an escharotic effect. Routine precaution for the use of any topical anesthetic should be observed when using this topical gel.
","Hypersensitivity Reactions: Unpredictable adverse reactions (i.e. hypersensitivity, including anaphylaxis) are extremely rare. Localized allergic reactions may occur after prolonged or repeated use of any aminobenzoate anesthetic. The most common adverse reaction caused by local anesthetics is contact dermatitis characterized by erythema and pruritus that may progress to vesiculation and oozing. This occurs most commonly in patients following prolonged self-medication, which is contraindicated. If rash, urticaria, edema, or other manifestations of allergy develop during use, the drug should be discontinued. To minimize the possibility of a serious allergic reaction, this topical gel preparations should not be applied for prolonged periods except under continual supervision. Dehydration of the epithelium or an escharotic effect may also result from prolonged contact.
","Safe use of this gel has not been established with respect to possible adverse effects upon fetal development. Therefore, this gel should not be used during early pregnancy, unless in the judgement of a physician, the potential benefits outweigh the unknown hazards. Routine precaution for the use of any topical anesthetic should be observed when this gel is used.
","On rare occasions, methemoglobinemia has been reported in connection with the use of benzocaine-containing products. Care should be used not to exceed the maximum recommended dosage. If a patient becomes cyanotic, treat appropriately to counteract (such as with methylene blue, if medically indicated).
",,,,,"Store in a cool and dry place, protect from light. Keep out of reach of children.
",9
+1671,β-Sitosterol,β-sitosterol-1671,,Herbal and Nutraceuticals,Wounds,"β-Sitosterol has been used successfully in the treatment of the following wounds:
+
+- Burn
+- Leg ulcer
+- Surgical wound
+- Obstetric wound
+- Cracked nipple
+
","Herbal and Nutraceuticals
",,"A thin layer of β-Sitosterol ointment should be applied to the whole burn/affected area 3-4 times daily.
",,,,"No side effects to the product have been reported so far except for rare allergic reactions to sesame oil.
",,"Avoid contact with eyes or mucous membrane. Avoid accidental ingestion. If swallowed, get medical treatment. β-Sitosterol ointment may vary its physical appearance during storage, especially during the hot season. But it does not lose its effcacy.
",,,,,"Store in a cool & dry place, below 30°C. Protect from direct sunlight & moisture. Keep the medicine out of the reach of children.
",6
+1520,Yohimbine Hydrochloride,yohimbine-hydrochloride-1520,,Herbal and Nutraceuticals,Libido,"Yohimbine is indicated in erectile dysfunction, loss of libido & exhaustion.
","Herbal and Nutraceuticals
","Yohimbe is a potent alpha-2 adrenoceptor blocker and a weak alpha-1 adrenergic antagonist with some antidopaminergic properties. Yohimbe interacts with adrenoceptors that are selectively stimulated by clonidine, alpha-methylnorepinephrine, tramazoline, guanabenz & guanfacin. It also interacts with compounds that are nonselectively stimulated by norepinephrine and epinephrine. Yohimbe has a modest beneficial effect in the management of erectile dysfunction. Because of the alpha-2 adrenergic blockade, the drug is an effective treatment for sexual disorders such as decreased libido and decreased sexual response, caused by selective serotonin reuptake inhibitors.
","1 capsule 3 times daily or as advised by the physician
",,"Theoretically, Yohimbe may counteract the hypotensive effect of antihypertensive medications, resulting inadequate blood pressure control. It may potentiate pharmaceutical MAO-inhibitors
","The drug should not be used by patients with liver and kidney diseases, chronic inflammation of the sexual organs or prostate gland or with a history of gastric or duodenal ulcers
","Anxiety states, elevated blood pressure, exanthema, nausea, insomnia, tachycardia, tremor, mania and vomiting.
",,"Patients taking Yohimbe should avoid alcohol ingestion
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+1704,White Damar + Acacia + Bole Rubra,white-damar-acacia-bole-rubra-1704,,Herbal and Nutraceuticals,Gastric ulcer,"This is indicated in-
+
+- Diarrhoea
+- Gastric ulcer
+- Duodenal ulcer
+- Convulsions
+
","Herbal and Nutraceuticals
","This is a unique medicine prepared with the valuable natural ingredients, which is highly effective in the treatment of diarrhoea. It strengthens the gastrointestinal barrier and prevents gastric & intestinal ulcer. It is also very effective to remove convulsion.
","1-2 tablet(s) 2-3 times daily or as prescribed by the physician.
",,,"There is no known contra-indication.
","No significant side effect has been observed in therapeutic dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1138,Vitamin E [Alpha Tocopherol Acetate],vitamin-e-alpha-tocopherol-acetate-1138,,Vitamin-E Preparations,Vitamin E deficiency and peripheral neuropathy,"As dietary supplement:
+
+- Vitamin E deficiency resulting from impaired absorption
+- Increased requirements due to diet rich in polyunsaturated fats
+- For healthy hair & skin
+- As an antioxidant
+- Hemolytic anemia due to Vitamin E deficiency
+
+Therapeutic
... Read moreAs dietary supplement:
+
+- Vitamin E deficiency resulting from impaired absorption
+- Increased requirements due to diet rich in polyunsaturated fats
+- For healthy hair & skin
+- As an antioxidant
+- Hemolytic anemia due to Vitamin E deficiency
+
+Therapeutic use:
+
+- Cardiovascular disease
+- Heavy metal poisoning
+- Hepatotoxin poisoning
+- Hemolytic anemia
+- Oxygen therapy
+- In nutritional deficiency states.
+
","Herbal and Nutraceuticals, Vitamin-E Preparations
","Vitamin E acts as an antioxidant in the body. Vitamin E protects polyunsaturated fatty acids (which are components of cellular membrane) and other oxygen-sensitive substances such as vitamin A & vitamin C from oxidation. In premature neonates irritability, edema, thrombosis and hemolytic anemia may be caused due to vitamin E deficiency. Creatinuria, ceroid deposition, muscle weakness, decreased erythrocyte survival or increased in vitro hemolysis by oxidizing agents have been identified in adults and children with low serum tocopherol concentrations.
","Betterment of cardiovascular health: 400 IU-800 IU per day
Deficiency syndrome in adults: 200 IU-400 IU per day
Deficiency syndrome in children: 200 IU per day
Thalassemia: 800 IU per day
Sickle-cell anemia: 400 IU per day
Betterment of skin & hair: 200 IU-400 IU per day (Topical use is also established for beautification)
Chronic cold in adults: 200 IU per day
",,"Vitamin E may impair the absorption of Vitamin A & function of Vitamin K and potentiates the effect of Warfarin.
","No known contraindications found.
","Overdosage (>1 gm) have been associated with minor side effects, including hypertension, fatigue, diarrhea and myopathy.
","Vitamin E is safe in pregnancy and lactation, when used as recommended doses. Higher doses are not established.
","It may increase the risk of thrombosis in some patients, such as those taking estrogens.
","Vitamin E is safe for children.
",,,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",11
+1672,Vitamin D3 + Vitamin K1 + Vitamin K2,vitamin-d3-vitamin-k1-vitamin-k2-1672,,Herbal and Nutraceuticals,Bleeding or blood clotting problems,"This is indicated in:
+
+- Support for cardiovascular health
+- Contribute to normal absorption and utilization of calcium and phosphorous in the body
+- Contribute to normal blood clotting
+- Contribute to the maintenance of normal bones
+
","Herbal and Nutraceuticals
","Phylloquinone is often called vitamin K1. Phylloquinone is fat soluble and stable in air and moisture. However, it degrades in sunlight. It is found naturally in a wide variety of green plants. Vitamin K is needed for the post translational modification of certain proteins, mostly required for blood coagulation.
Vitamin K2 is necessary for the activation of osteocalcin, a protein that transports and integrates calcium into bone to ensure a healthy skeleton. Incorporating calcium into the bone matrix means that less calcium is available for harmful deposits in soft body tissues.
Vitamin D3 (Cholecalciferol) is essential for normal bone growth & development and to maintain bone density. It also helps our body to utilize both Calcium & Phosphorus
","Adults and children over 12 years of age: 1-2 capsule daily or as directed by the physician.
",,"Vitamin K antagonizes the effect of coumarin-type anticoagulants. Co-administration of anticonvulsants can impair the action of vitamin K. Cholecalciferol is known to interact with Carbamazepine, Dactinomycin, Diuretics, Fosphenytoin, Miconazole, Phenobarbital, Phenytoin, Primidone.
","Contraindicated in patients with known hypersensitivity to any of the ingredients.
","Well tolerated in recommended dose.
","Vitamin K & D3 is safe in pregnancy & lactation when used as recommended doses.
",,,,,,"Store at a cool & dry place below 30°C temperature, Protect from direct sunlight & moisture. Do not freeze.
",9
+1751,Vaskar Laban [Piper + Zingiber + Cinnamomum],vaskar-laban-piper-zingiber-cinnamomum-1751,,Herbal and Nutraceuticals,Indigestion,"This is indicated in loss of appetite, indigestion.
","Herbal and Nutraceuticals
","Piper longum-
+
+- Chemical constituents: piperine, piplartine, essential oil, two liquid alkaloids-triacontane, sesamin etc.
+- Action: It is used as nerve tonic, carminative, digestive and strengthen muscular system. It can use in haemorroids, splenic disorders.
+
+Zingiber officinale-
+
+- Chemical constituents: Zinziberin, zingerfone, terpenes, cineol, borneol, citral, camphene, phelandrene, gingerol, shogaol, etc.
+- Actions: It is digestive, carminative, stomachic & stimulant. It is used in dyspepsia, flatulent, colic, vomiting and constipation.
+
+Cinnamomum zeylanicum-
+
+- Chemical constituents: Cinnamon contains volatile oil (1-6%), phlobatannin, mucilage, calcium oxalate, sugar and starch. The principal constituent of the volatile oil is cinnamic aldehyde (60-75%).
+- Actions: Cinnamon is pungent, aromatic, astringent, stimulant and carminative. It is employed as flavoring agent. It has antiseptic and antidiarrhoeal properties and is a powerful germicide.
+
","1-2 tablets 2/3 times daily.
",,,"There is no absolute contraindication.
","Not yet known.
",,,,,,,"Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.
",7
+1681,Valerian Root,valerian-root-1681,,Herbal and Nutraceuticals,Spasm,"Valerian Root is indicated in-
+
+- Insomnia
+- Anxiety
+- Nervous excitation
+- Muscle spasm and pain
+- Restlessness
+- Migraine
+- Lack of concentration
+
","Herbal and Nutraceuticals
","Valerian capsule is a special preparation of standardized extract of Valerian root. Valerian is a perennial herb, ranging from 2-5 feet in height, native to Eurasia and North America. Valerian acts as centrally depressive, sedative, tranquilizer, anxiolytic, antioxidant, spasmolytic, analgesic, anti-inflammatory and muscle relaxant.
","1-2 capsule(s) daily 30 minutes before bed time or as prescribed by the physician.
",,,"Valerian is contraindicated in case of hypersensitivity to the plant.
","No significant side effect has been observed in therapeutic dosage. Over dosage may cause headache, depression, nausea, lethargy, uneasiness, bradycardia, arrhythmias and decrease intestinal motility.
",,"Valerian should not be administered during pregnancy, lactating mother and children without medical supervision.
",,,,,"Store in a cool and dry place. Protect from sunlight. Keep out of reach of children.
",8
+1842,Tocotrienol + Tocopherol,tocotrienol-tocopherol-1842,,Herbal and Nutraceuticals,"Maintain healthy skin, hair, nail, teeth, bone, eye and nervous system","
+- Supports healthy hair & skin
+- Supports brain health & cognitive function
+- Powerful antioxidant
+- Helps to maintain healthy blood vessels
+
","Herbal and Nutraceuticals
","Vitamin E is a fat soluble vitamin. Structurally both tocotrienol and tocopherol have a chroman ring as the head but are distinguished by their side chain. Tocopherol has a saturated side chain whereas tocotrienol has three double bonds in its side chain. This is why tocotrienol is sometimes called the unsaturated vitamin E. While very similar in structure to tocopherol, research has shown that tocotrienols have additional biological activities which are not shown by the alpha-tocopherol.
","Adults and above 18 years: 1-2 capsules daily or as directed by the physician.
",,"Patients on cholesterol-lowering medication should only consume the product under medical supervision.
","Contraindicated in patients with known hypersensitivity to any of the ingredients.
","Well tolerated in recommended dose.
","Not recommended for pregnant or lactating women.
",,,,,,"Store at a cool & dry place below 25°C. Protect from direct sunlight & moisture. Do not freeze.
",9
+1724,"Tila Jadeed [Madar, Mace arillus, Nutmeg nut]",tila-jadeed-madar-mace-arillus-nutmeg-nut-1724,,Herbal and Nutraceuticals,Sluggishness,"This is indicated in-
+
+- Sluggishness
+- Feebleness
+- Curvature
+- Shortness
+- Obliquity of male organ.
+
","Herbal and Nutraceuticals
","This is highly effective in sluggishness, feebleness, curvature, shortness and obliquity of male organ. For excessive indulgence in sexual acts or other causes nerve, blood vessel and tissue lost their elasticity and blood cannot store long time in the blood vessel which reduces the erecting time and makes the male organ weak. This preparation strengthens the tissue, stimulates the nerves and muscles as well as the flow of blood in the male organ, thus providing it stiffness and full erection. It also increases the elasticity of male organ.
","Rub gently 5-6 drops on male organ at bed time or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Sexual copulation is strictly prohibited during use. Discontinue if there is any side effect and apply coconut oil on effected portion. Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1843,Tart Cherry,tart-cherry-1843,,Herbal and Nutraceuticals,Antioxidant,"Tart Cherry is indicated in-
+
","Herbal and Nutraceuticals
",,"Once-daily dose with a glass of water or as advised by the physician. At least 3 months repeated course is feasible as advised by the physician.
",,,"Known hypersensitivity to Tart cherry.
","Generally well-tolerated in the recommended dose. Occasionally may cause gastrointestinal discomfort
","Avoid during pregnancy and lactation due to insufficient data.
",,,,,,"Do not store above 30°C. Store away from light & moisture. Keep out of reach of children.
",7
+1682,Tabkheer,tabkheer-1682,,Herbal and Nutraceuticals,Indigestion,"Tabkheer is indicated in-
+
+- Gastroesophageal reflux disorders
+- Flatulence
+- Indigestion
+- Hyperacidity
+
","Herbal and Nutraceuticals
",,"1-2 capsule(s) daily or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been reported in therapeutic dosage.
",,"Keep out of reach of the children.
",,,,,"Store in cool and dry place, protect from light.
",7
+1735,"Suzark [Chir Pine, Chickpea, Pearl]",suzark-chir-pine-chickpea-pearl-1735,,Herbal and Nutraceuticals,Vaginal leucorrhoea,"This is indicated in-
+
+- Gonorrhea
+- Burning sensation during urination
+- Urinary tract infection
+- leucorrhoea
+
","Herbal and Nutraceuticals
","This is a special preparation of Chir Pine (Pinus longifolia), Chickpea (Cicer arietinum) and other natural ingredients, which is highly effective in gonorrhea, burning sensation during urination and urinary tract infection.
","1 tablet twice daily before meal or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,,7
+1734,Suranjan,suranjan-1734,,Herbal and Nutraceuticals,Rheumatoid arthritis,"This is indicated in-
+
+- Gout
+- Rheumatoid arthritis
+- Osteoarthritis
+- Lumbago
+- Capsulitis
+- Bursitis
+- Sciatica
+
","Herbal and Nutraceuticals
","This is a unique combination of Colchicum (Colchicum luteum), Aloe (Aloe barbadensis) and other valuable natural ingredients. It is highly effective in all kinds of rheumatism such as chronic rheumatoid arthritis, osteoarthritis, sciatica, lumbago, gout, joint pain and muscular pain.
","1-2tablet(s) twice daily after meal or as directed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1820,Steviol Glycoside,steviol-glycoside-1820,,Herbal and Nutraceuticals,Artificial sweetener,"Steviol Glycoside can be used as sweetener in different foods like pudding, milk products, jelly, tea, coffee, hot and cold beverage, fruit juice etc. Due to zero calorie sweetener it is an excellent preparation for the health conscious people, diabetes & obese patients. It is also suitable for everyone including children who wants to reduce calorie intake.
","Herbal and Nutraceuticals
",,"As required
",,,,,,,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",4
+111,Benzocaine,benzocaine-111,https://medex.com.bd/attachments/nEgUpYaWEfMxkjjWg4B2336KHBAwcJ/benzocaine-prescribing-information,Local & Surface anesthesia,Toothache,"For the temporary relief of pain due to minor injury or irritation of the mouth and gums like Toothache, Sore gums, Canker sores, Braces, Minor dental procedures, Dentures
","Local & Surface anesthesia
","Benzocaine, an ester local anaesthetic, blocks the initiation and conduction of nerve impulses by decreasing the neuronal membrane’s permeability to Na ions, which results in inhibition of depolarisation with resultant blockade of conduction.
","Apply to the affected area up to 4 times daily or as directed by a doctor/dentist. Children under 12 years of age should be supervised during the use of this product. Children under 2 years of age should be consulted to a doctor/dentist prior to the use of this product. An easy application might be done by fixing applicator on the tube’s nozzle. After application, supplied cap should be fixed on top of the applicator.
",,"May antagonise the therapeutic effect of sulfonamides. Anticholinesterases may inhibit the metabolism benzocaine.
","Epiglottis (oral spray), methaemoglobinaemia.
","Side effects are less common. The side effects include allergies, swelling in the mouth or throatetc.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
","Patient with asthma, bronchitis, emphysema, heart disease; smokers. Children, Pregnancy and lactation.
",,"Symptom: Methaemoglobinaemia, manifested by cyanotic (greyish) skin discolouration, unusual breathing or breathlessness.
Management: Symptomatic and supportive treatment. IV methylene blue 1% may be administered.
",,,"Store between 15-30° C.
",11
+110,Benzathine Penicillin,benzathine-penicillin-110,https://medex.com.bd/attachments/wd3otHrHl4xD0SlOw2VRa9aQqyS0Iy/benzathine-penicillin-revised-27-march-2018-prescribing-information,Long acting penicillin,Uncomplicated pneumococcal pneumonia,"Benzathine Penicillin is indicated in-
+
+- The treatment of penicillin-sensitive infections where initial high blood levels are not required.
+- The prophylaxis of penicillin-sensitive secondary infections especially in children. It is particularly valuable in continuous prophylaxis against rheumatic fever and streptococcal infections.
... Read more
Benzathine Penicillin is indicated in-
+
+- The treatment of penicillin-sensitive infections where initial high blood levels are not required.
+- The prophylaxis of penicillin-sensitive secondary infections especially in children. It is particularly valuable in continuous prophylaxis against rheumatic fever and streptococcal infections.
+- Prophylaxis of streptococcal impetigo
+- Treatment of acute otitis media
+- Treatment of syphilis
+- Treatment of diphtheria carriers
+
","Long acting penicillin
","Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs); which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.
","Treatment of infection: 0.3 to 1.2 million units repeated every five to seven days.
Prophylaxis of rheumatic fever: 1.2 million units every three weeks.
Specific dosage schedule: Treatment of group-A β-haemolytic streptococcal infections: A single intramuscular dose of 600,000 units.
Prevention of rheumatic fever: Monthly injection of a single dose of 1.2 million units is the most effective regimen for preventing further attacks of rheumatic fever.
Treatment of acute otitis media: A single injection of 6 million units.
+
+- Early syphilis- 2.4 million units as a single dose.
+- Late syphilis: 2.4 million units weekly for three successive weeks.
+- Neurosyphilis: Benzylpenicillin, intravenously, 2 to 4 million units every 4 hours for 10 days, followed by benzathine penicillin intramuscularly, 2.4 million units weekly for three successive weeks.
+- Congenital syphilis: Asymptomatic infants with normal cerebrospinal fluid, intramuscularly 50,000 units per kg in a single dose.
+
+Primary and secondary syphilis have been treated with single injections of 2.4 million units of long acting benzathine penicillin (Benzapen) weekly for 2 to 4 weeks with satisfactory results.
",,"No potentially hazardous interactions have been described.
","Hypersensitivity to penicillins
","The toxicity of penicillins is generally low, but in a small number of patients penicillin can cause sensitization and allergic reactions. Acute, lifethreatening anaphylactic reactions are rare, but they do occur.
Intramuscular injection of benzathine penicillin can cause moderate burning discomfort, local pain, and deep muscle soreness and tenderness at the site of injection, lasting for one to three days in about 10% of patients. Some patients had low-grade fever (102˚F) associated with local pain and tenderness. This febrile reaction disappeared within 24 to 48 hours.
","Pregnancy category B. Benzathine Penicillin should not be administered during pregnancy unless in the judgment of the physician such administration is clinically justifiable. Special care should be taken in the first three months of pregnancy.
As penicillin appears in breast milk, it is probably best for a mother to stop breast-feeding while being given penicillin to avoid exposing the infant to the drug unnecessarily.
","Patient with previous hypersensitivity reactions to cephalosporins, history of allergy, asthma, seizure disorder. Not intended for IV or intra-arterial admin or inj near major peripheral nerves of blood vessels. Prolonged use may result in bacterial or fungal superinfection. Renal impairment.
",,,,,"Store between 2-8°C. Do not freeze.
",10
+133,Bisacodyl,bisacodyl-133,https://medex.com.bd/attachments/XSYDnB2lXoF9xOiYYSYWhu0AoZd4sC/bisacodyl-revised-july-2010-prescribing-information,Stimulant purgatives,Osmotic purgative,"Bisacodyl is indicated in the-
+
+- Treatment of constipation.
+- Preparation for radiographic or endoscopic examination of the colon.
+
","Stimulant purgatives
","Bisacodyl is a diphenolic compound. Its chemical structure is similar to that of phenolphthalein. It is widely used as a laxative. Bisacodyl acts on the colon to stimulate peristalsis and on the small bowel and colon to increase intraluminal water and electrolytes. When applied to the caecum, Bisacodyl initiates a response in the entire colon.
","Constipation-
+
+- Adult: 5-10 mg at night; occasionally necessary to increase to 15-20 mg;
+- Child under 10 years: 5 mg.
+
+Before radiological procedures and surgery-
+
+- Adult: 10 mg orally at bed-time for 2 days before the examination.
+- Child: half of the adult dose.
+
",,,"Ileus, intestinal obstruction, acute surgical abdominal conditions such as acute appendicitis, and acute inflammatory bowel diseases, severe dehydration.
","Bisacodyl is free of side effects if taken in the recommended doses. Overuse of bisacodyl may result in diarrhea and malabsorption. Bisacodyl overuse might be expected to deplete potassium.
","Bisacodyl like other medicines, should not be used during pregnancy especially the first trimester. In breastfeeding women, bisacodyl should be cautiously used.
","Excessive use of bisacodyl may lead to fluid and electrolyte imbalance. Chronic use can cause dependence.
",,,,,"Store in a cool and dry place, protected from light.
",9
+611,Biphasic Insulin Aspart [rDNA],biphasic-insulin-aspart-rdna-611,https://medex.com.bd/attachments/n5gxx6lXRznRLOa1kDcnHuRU0jEkAR/biphasic-insulin-aspart-rdna-revised-march-2008-prescribing-information,Combination Insulin,Type 1 DM,"Biphasic Insulin Aspart (rDNA) is indicated to improve glycemic control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
","Combination Insulin
","30% Insulin Aspart and 70% Insulin Aspart Protamine (rDNA) is a human insulin analog suspension containing 30 % soluble Insulin Aspart and 70% Insulin Aspart Protamine crystals. This is a blood glucose lowering agent with an earlier onset and an intermediate duration of action. Insulin Aspart is homologous with regular human insulin with the exception of a single substitution of the proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Saccharomyces cerevisiae (baker’s yeast).
Primary function of insulin, including Insulin Aspart, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, primarily by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.
","The dosage of insulin aspart must be individualized.
Subcutaneous injection: insulin aspart should generally be given immediately (within 5-10 minutes) prior to the start of a meal.
Use in pumps: Change the insulin aspart in the reservoir at least every 6 days, change the infusion set, and the infusion set insertion site at least every 3 days. insulin aspart should not be mixed with other insulins or with a diluent when it is used in the pump.
Intravenous use: insulin aspart should be used at concentrations from 0.05 U/mL to 1.0 U/mL insulin aspart in infusion systems using polypropylene infusion bags. insulin aspart has been shown to be stable in infusion fluids such as 0.9% sodiumchloride.
","Before going for administration of Biphasic Insulin Aspart (rDNA) please follow the below mentioned check list:
+
+- Insulin syringe of the right size (100 units/ml)
+- Prescribed type of insulin injection
+- Check the expiry date on Biphasic Insulin Aspart (rDNA) vial
+- Ensure that the flip off cap on the Biphasic Insulin Aspart (rDNA) vial is intact
+
+After that follow the below mentioned instructions:
+
+- Wash your hands carefully. Shake or roll the vial 10 times to completely Mix the insulin.
+- lnspect the vial. Vial should appear white and cloudy after mixing.
+- When using a new vial, flip off the plastic protective cap, but do not remove the stopper. The tip of the vial should be wiped with an alcohol swab.
+- Draw air into the syringe equal to your insulin dose.
+- Insert needle into vial through rubber top & push plunger to empty the air into the vial.
+- Turn the bottle and syringe upside down. Hold the bottle and syringe firmly in one hand and shake gently. Make sure that the tip of the needle is in the liquid; withdraw the correct dose of insulin into the syringe.
+- Before removing the needle from the vial, check the insulin syringe for air bubbles, which reduces the amount of insulin in it, if bubbles are present, hold the insulin straight up and tap its side until the bubbles float to the top. Push them out with the plunger and withdraw the correct dose again.
+- Lightly pinch up the skin, holding the syringe like a pencil.
+- Insert the needle into the skin & push the plunger slowly. Make sure that the needle is all the way in.
+- Wait for 5 seconds & pull out the syringe. Do not rub the area.
+
","A number of substances affect glucose metabolism and may require dose adjustment and particularly close monitoring.
The following are examples that may increase the blood glucose lowering effect and susceptibility to hypoglycemia: oral anti-diabetic products, pramlintide and angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, propoxyphene, salicylates and sulfonamide antibiotics.
The following substances are examples that may reduce the blood glucose lowering effect: corticosteroids, niacin, danazol, diuretics, sympathomimetic agents, isoniazid, phenothiazine derivatives, somatropin, estrogens, progestogens, atypical antipsychotics and danazol. Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
","Biphasic Insulin Aspart (rDNA) is contraindicated
+
+- During episodes of hypoglycemia
+- In patients with hypersensitivity to Insulin Aspart or any of its excipients.
+
","Side effects of Insulin Aspart are hypoglycemia, lipodystrophy, weight gain, peripheral edema.
","Pregnancy category B. Careful monitoring of glucose control is essential in such patients because insulin requirements change during different stages of pregnancy. Therefore female patients should be advised to tell their physician if they intend to become or if they become pregnant while taking insulin aspart
Lactation: It is unknown whether Insulin Aspart is excreted in human milk as occurs with human insulin. There are no adequate and well-controlled studies of the use of insulin aspart in lactating women. Lactating Women may require adjustments of their insulin doses.
","Dose adjustment and monitoring: Blood glucose should be monitored in all patients treated with insulin. Insulin regimens should be modified cautiously and only under medical supervision.
Renal or hepatic impairment: Reduction in the Insulin Aspart dose may require in these cases.
","Pediatric: Has not been studied in children with type 2 diabetes. Has not been studied in children with type 1 diabetes <2 years of age
","Insulin Aspart overdose may result in hypoglycemia. Mild episodes of hypoglycemia can usually be treated with oral carbohydrates. Severe hypoglycemia may be treated with parenteral glucose or injections of glucagon. Adjustments in drug dosage, meal patterns, or exercise may be needed.
",,,"Store at 2°C to 8°C in a refrigerator. Do not freeze. In case of insulin for recent use need not be refrigerated, try to keep it in a cool place and keep away from heat and light. The insulin in use can be kept under the room temperature for a month.
",13
+1301,Bimatoprost + Timolol,bimatoprost-timolol-1301,https://medex.com.bd/attachments/d7MlfX3LnVGLPAosxtCZtZwNPdLMEj/bimatoprost-timolol-prescribing-information,Other ophthalmic preparations,Open angle glaucoma,"This Eye Drops is indicated for the reduction of intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to mono-therapy.
","Other ophthalmic preparations
","Bimatoprost is believed to lower intraocular pressure (IOP) in humans by increasing outflow of aqueous humor through both the trabecular meshwork and uveoscleral routes. Bimatoprost reduces the pressure in the eye by mimicking the action of a naturally-occuring prostaglandin. Prostaglandins are a group of chemicals found in many places in the body. In the eye, they increase the drainage of the aqueous humour out of the eyeball. Bimatoprost is a synthetic compound related to one of the natural prostaglandins, and works by increasing the drainage of aqueous humour out of the eyeball. Bimatoprost may also lower the rate of aqueous formation in the eye. Both these effects decrease the pressure within the eye.
Similar to propranolol and nadolol, timolol is a non-selective, beta-adrenergic receptor antagonist. Timolol does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic (membrane-stabilizing) activity, but does possess a relatively high degree of lipid solubility. Timolol, when applied topically to the eye, has the action of reducing elevated, as well as normal, intraocular pressure, whether or not accompanied by glaucoma. Elevated intraocular pressure is a major risk factor in the pathogenesis of glaucomatous visual field loss and optic nerve damage.
","The recommended dose is one drop in the affected eye(s) once-daily.
",,"There is a potential for bradycardia when ophthalmic beta blockers solution is administered concomitantly with oral calcium channel blockers, guanethidine, beta-adrenergic blocking agents, parasympathomimetics, anti-arrhythmics and digitalis glycosides. Concomitant ocular medications should be administered at least 5 min apart from the instillations of this Eye Drops
","It is contraindicated in patients with known hypersensitivity to any ingredient of this formulation.
","In clinical trials, Ocular hyperemia was reported in approximately 26% of patients. 5 to 10 % in these clinical studies included decreased visual acuity, eye discomfort, foreign body sensation, pain and pruritis.
","Use in Pregnancy: There are no adequate data from the use of the Bimatoprost / Timolol fixed combination in pregnant women. It should not be used during pregnancy unless clearly necessary.
Use in Lactation: Animal studies showed Bimatoprost is excreted in rat’s milk. & Timolol is excreted in human milk. Therefore, Bimatoprost / Timolol should not be used during breastfeeding.
","Like other topically applied ophthalmic medicinal products, the active substances Timolol/ Bimatoprost may be absorbed systemically. Due to the beta-adrenergic component, Timolol, the same types of cardiovascular, pulmonary and other adverse reactions as seen with systemic beta-blockers may occur. Caution should be exercised in treating patients with severe or unstable and uncontrolled cardiovascular Disease.
","Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
",,,,"Store below 25° C in a dry place protected from light. Keep out of reach of children. Solution can be used up to 28 days after first opening.
",11
+132,Bimatoprost,bimatoprost-132,https://medex.com.bd/attachments/gxAD1IVL5enWaxSAT9UChCnahOK8Rn/bimatoprost-003-ophthalmic-solution-prescribing-information,Drugs for miotics and glaucoma,Open angle glaucoma,"Bimatoprost is indicated for Ocular hypertension, Open-angle glaucoma
","Drugs for miotics and glaucoma
","Bimatoprost is believed to lower intraocular pressure (IOP) in humans by increasing outflow of aqueous humor through both the trabecular meshwork and uveoscleral routes. Bimatoprost reduces the pressure in the eye by mimicking the action of a naturally-occuring prostaglandin. Prostaglandins are a group of chemicals found in many places in the body. In the eye, they increase the drainage of the aqueous humour out of the eyeball. Bimatoprost is a synthetic compound related to one of the natural prostaglandins, and works by increasing the drainage of aqueous humour out of the eyeball. Bimatoprost may also lower the rate of aqueous formation in the eye. Both these effects decrease the pressure within the eye.
","Adult: Instill 1 drop into affected eye(s) once every night.
",,"There is not known drug interactions and none well documented.
","Known hypersensitivity.
","Common side effects are: Burning/stinging/irritation/ redness/discomfort of the eye, Feeling as if something is in your eye, Dry eyes, Watering eyes, Temporary unstable vision, Increased sensitivity to light, Dizziness.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
","May increase pigmentation of the iris, periorbital tissue and eyelashes. Active intraocular inflammation. Safety and efficacy have not been evaluated in the treatment of inflammatory, neovascular or angle closure glaucoma. Ensure at least an interval of 5 minutes between admin of ophthalmic preparations. Contact lenses should be removed prior to admin. Pregnancy, lactation.
",,"Treatment is symptomatic.
",,,"Store at 2-25° C.
",11
+1457,Bilastine,bilastine-1457,https://medex.com.bd/attachments/mfEPBDDHGXxD3TJlPOI0Bw3eGy6SAL/bilastine-20-mg-tablet-prescribing-information,Non-sedating antihistamines,Urticaria,"Bilastine is indicated for symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria.
","Non-sedating antihistamines
","Bilastine is a non-sedating, long-acting histamine antagonist with selective peripheral H 1 receptor antagonist affinity and no affinity for muscarinic receptors. Bilastine inhibits histamine-induced wheal and flare skin reactions for 24 hours following single doses.
","Adults & adolescents (12 years of age and over): 20 mg tablet once daily for symptomatic relief of allergic rhinitis, urticaria and allergic rhinoconjunctivitis. The maximum recommended daily dose is 20 mg Bilastine (1 tablet) and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken. 20 mg Bilastine tablet (1 tablet) once daily should be swallowed with water on an empty stomach to achieve optimal exposure to Bilastine.
Children between 6 to 11 years: 10 mg mouth dissolving tablet for the symptomatic relief of allergic rhinitis, allergic rhinoconjunctivitis and urticaria. The Mouth dissolving tablet is for oral use only. It should be placed in the mouth. It will disperse rapidly in saliva and can be easily swallowed. Alternatively, the mouth dissolving tablet can be dispersed in a tea spoon of water before being swallowed by the children. The maximum recommended daily dose for children in between 6 to 11 years is 10 mg Bilastine mouth dissolving tablet (1 tablet) and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken.
Children between 2 to 11 years: 4 ml once daily.
",,"Concomitant intake of Bilastine and Ketoconazole or Erythromycin or Diltiazem increased C max of Bilastine. The psychomotor performance after concomitant intake of alcohol and Bilastine was similar to that observed after intake of alcohol and placebo. Concomitant intake of Bilastine and Lorazepam 3 mg for 8 days did not potentiate the depressant CNS effects of Lorazepam.
","Bilastine is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients of the tablet.
","The most commonly reported side effects in clinical trial are headache, dizziness, somnolence and fatigue. These adverse events occurred with a comparable frequency in patients receiving placebo.
","There are no or limited amount of data from the use of Bilastine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, parturition or postnatal development. As a precautionary measure, it is preferable to avoid the use of Bilastine during pregnancy. The excretion of Bilastine in milk has not been studied in humans. A decision must be made taking into account the benefit of breast-feeding for the child and the benefit of Bilastine therapy for the mother.
","Co-administration of Bilastine and P-glycoprotein inhibitors (e.g. Ketoconazole, Erythromycin, Cyclosporine, Ritonavir or Diltiazem) should be avoided in patients with moderate or severe renal impairment.
","Efficacy and safety of Bilastine in children under 2 years of age have not been established and there is little clinical experience in children aged 2 to 5 years, therefore Bilastine should not be used in these age groups.
","In clinical trials, after administration of Bilastine at doses 10 to 11 times the therapeutic dose (220 mg as single dose; or 200 mg/day for 7 days) frequency of treatment-emergent adverse events was two times higher than with placebo. The adverse reactions most frequently reported were dizziness, headache and nausea. No serious adverse events and no significant prolongation in the QTc interval were reported.
",,,"Keep below 30°C temperature, protected from light and moisture. Keep out of reach of children.
",12
+993,Bicarbonate Component [HCO3 Hemodialysis Solution],bicarbonate-component-hco3-hemodialysis-solution-993,https://medex.com.bd/attachments/S9zYG5JfFCm5yYsbfLUzVK1i0JkCeY/bicarbonate-component-hco3-hemodialysis-solution-prescribing-information,Haemodialysis solutions,Haemodialysis,"Bicarbonate Component [HCO3 Hemodialysis Solution] solution is indicated in renal failure, Chronic renal failure and Haemodialysis. Bicarbonate serves a crucial biochemical role in the physiological pH buffering system.
","Haemodialysis solutions
","Sodium chloride is the major extracellular cation. It is important in electrolyte and fluid balance, osmotic pressure control and water distribution as it restores sodium ions. It is used as a source of electrolytes and water for hydration, treatment of metabolic acidosis, priming solution in haemodialysis and treatment of hyperosmolar diabetes. It is also used as diluents for infusion of compatible drug additives. Sodium bicarbonate raises blood and urinary pH by dissociation to provide bicarbonate ions, which neutralises the hydrogen ion concentration. It also neutralises gastric acid via production of carbon dioxide.
","Acidic component & Bicarbonate Component should be used in the dilution ratio of-
+
+- Acidic component: 1.00 Volume
+- Bicarbonate Component: 1.83 Volume
+- Purified Water: 34.00 Volume
+
",,"Sodium bicarbonate: Increases toxicity of amphetamines, ephedrine, pseudoephedrine, flecainide, quinidine and quinine. Decreases effects of lithium, chlorpropamide and salicylates due to increased clearance. May affect the absorption of certain drugs due to raised intra-gastric pH. Sodium chloride: May affect serum concentrations of lithium.
","Known hypersensitivity to any of the ingredients of this preparation.
",,,"
+- Bicarbonate Component needs to be used with Acidic component (not to be used alone).
+- Before use, the mixed solution must be diluted with
+- highly purified water.
+- Close the container tightly immediately after use.
+- Discard solution in case of visible solid particles inside.
+- Discard solution after 96 hours of first opening.
+
",,,,,"Keep out of reach of children. Not for Injection. Store below 30°C.
",8
+1289,Bicalutamide,bicalutamide-1289,https://medex.com.bd/attachments/nsqzofUDIwXE8mw7B64SGlzuya34Pb/bicalutamide-revised-july-13-2017-prescribing-information,Hormonal Chemotherapy,Metastatic prostate cancer,"Bicalutamide 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate.
Bicalutamide 150 mg daily is not approved for use alone or with other treatments
","Hormonal Chemotherapy
","Bicalutamide is a non-steroidal androgen receptor inhibitor. It competitively inhibits the action of androgens by binding to cytosol androgen receptors in the target tissue. Prostatic carcinoma is known to be androgen sensitive and responds to treatment that counteracts the effect of androgen and/or removes the source of androgen.
When Bicalutamide is combined with luteinizing hormone releasing hormone (LHRH) analog therapy, the suppression of serum testosterone induced by the LHRH analog is not affected. However, in clinical trials with Bicalutamide as a single agent for prostate cancer, rises in serum testosterone and estradiol have been noted.
In a subset of patients who have been treated with Bicalutamide and an LHRH agonist, and who discontinue Bicalutamide therapy due to progressive advanced prostate cancer, a reduction in Prostate Specific Antigen (PSA) and/or clinical improvement (antiandrogen withdrawal phenomenon) may be observed.
","The recommended dose for Bicalutamide therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening), with or without food. It is recommended that Bicalutamide be taken at the same time each day. Treatment with Bicalutamide should be started at the same time as treatment with an LHRH analog.
",,"May induce torsade de pointes or QT prolongation if co-administered with class IA (e.g. quinidine) or class III (e.g. amiodarone) antiarrhythmic agents, methadone, antipsychotics, moxifloxacin. Enhanced anticoagulant effect of warfarin. Increased adverse effects when used with drugs that may inhibit oxidation (e.g. cimetidine, ketoconazole). May increase serum levels of ciclosporin and Ca channel blockers.
","Females, children, Pregnancy and lactation. Concomitant use of terfenadine, astemizole or cisapride.
","Anaemia; angioedema, urticaria; decreased appetite, DM, wt gain, dehydration, gout; decreased libido, depression, anxiety, hypertonia, confusion, neuropathy, nervousness, dizziness, somnolence; hot flush; abdominal pain, constipation, nausea, dyspepsia, flatulence, anorexia, rectal haemorrhage, dry mouth, melaena; hepatotoxicity, jaundice, hypertransaminasaemia; alopecia, hirsutism, dry skin, pruritus/rash, photosensitivity; haematuria, dysuria, urinary retention, impaired urination, urinary frequency; gynaecomastia, breast tenderness, erectile dysfunction; asthenia, oedema, chest pain, neck pain, fever, sepsis, chills, neoplasm; cough, pharyngitis, bronchitis, pneumonia, rhinitis.
","Pregnancy category X. Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
Nursing Mothers: Bicalutamide is not indicated for use in women.
","Patient with decreased bone density, history of or risk factors for QT prolongation, diabetes, Moderate to severe hepatic and severe renal impairment (CrCl <30 mL/min).
","Renal Impairment: No dosage adjustment is necessary for patients with renal impairment.
Hepatic Impairment: No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. In patients with severe liver impairment (n=4), although there was a 76% increase in the half-life (5.9 and 10.4 days for normal and impaired patients, respectively) of the active enantiomer of bicalutamide no dosage adjustment is necessary.
Pediatric Use: The safety and effectiveness of Bicalutamide in pediatric patients have not been established.
Geriatric Use: In two studies in patients given 50 or 150 mg daily, no significant relationship between age and steady-state levels of total bicalutamide or the active R-enantiomer has been shown.
Women: Bicalutamide has not been studied in women.
","Long-term clinical trials have been conducted with dosages up to 200 mg of Bicalutamide daily and these dosages have been well tolerated. A single dose of Bicalutamide that results in symptoms of an overdose considered to be life threatening has not been established. There is no specific antidote; treatment of an overdose should be symptomatic.
In the management of an overdose with Bicalutamide, vomiting may be induced if the patient is alert. It should be remembered that, in this patient population, multiple drugs may have been taken. Dialysis is not likely to be helpful since Bicalutamide is highly protein bound and is extensively metabolized. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.
",,,"Store at controlled room temperature, 20° to 25° C.
",12
+1579,Betrixaban,betrixaban-1579,https://medex.com.bd/attachments/njZhIh31mkIu4uA4RNXjcyPeUQALFh/betrixaban-prescribing-information,Anti-platelet drugs,Venous thromboembolism,"Betrixaban is indicated for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness and at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.
","Anti-platelet drugs
","Betrixaban is a factor Xa inhibitor that selectively blocks the active site of factor Xa and does not require a cofactor (such as Anti-thrombin III) for activity. Betrixaban inhibits free factor Xa and prothrombinase activity. By directly inhibiting factor Xa, Betrixaban decreases thrombin generation (TG). Betrixaban has no direct effect on platelet aggregation.
","The recommended dose of Betrixaban is an initial single dose of 160 mg, followed by 80 mg once daily. Daily oral doses should be given at the same time of day with food. The recommended duration of treatment is 35 to 42 days.
",,"P-gp Inhibitors: Increase the blood level of Betrixaban.
P-gp Inducers: Decrease the blood level of Betrixaban.
Anticoagulants, Antiplatelets and Thrombolytics: May increase the risk of bleeding
","Betrixaban is contraindicated in patients with active pathological bleeding. It is also contraindicated in patients with severe hypersensitivity reaction to Betrixaban
","Most common adverse reaction is bleeding, epidural or spinal hematoma may develop during spinal/epidural anesthesia or puncture.
","Use in Pregnancy: There are no data with the use of Betrixaban in pregnant women, but treatment is likely to increase the risk of hemorrhage during pregnancy and delivery.
Lactation: No data are available regarding the presence of Betrixaban or its metabolites in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production.
","Risk of Bleeding: Can cause bleeding. Promptly evaluate any signs or symptoms of blood loss.
Spinal/Epidural Anesthesia or Puncture: When neuraxial anesthesia (spinal/epidural anesthesia) or spinal/epidural puncture is employed, patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis. Do not remove an epidural catheter earlier than 72 hours after the last administration of Betrixaban. Do not administer the next Betrixaban dose earlier than 5 hours after the removal of the catheter. If traumatic puncture occurs, delay the administration of Betrixaban for 72 hours.
Severe Renal Impairment: Increase risk of bleeding events.
Concomitant P-gp Inhibitors: Increase risk of bleeding events.
","Patients with Severe Renal Impairment: No dose adjustment is needed for mild or moderate renal impairment (CrCl>30 mL/min). For patients with severe renal impairment (CrCl≥15 to <30 mL/min) the recommended dose of Betrixaban is an initial single dose of 80 mg followed by 40 mg once daily.
Patients with Hepatic Impairment: No dose adjustment is required in patients with mild hepatic impairment. Avoid use in patients with moderate to severe hepatic impairment.
",,,,"Protect from light and moisture, store below 30°C. Keep the medicine out of reach of children.
",11
+131,Bevacizumab,bevacizumab-131,https://medex.com.bd/attachments/cIrJ8jIkvGz4USF0S9PYpiPY4lV2IB/bevacizumab-prescribing-information,Targeted Cancer Therapy,Wet age-related macular degeneration,"Bevacizumab is indiated for-
+
+- Metastatic Colorectal Cancer (mCRC)
+- Non-Squamous Non–Small Cell Lung Cancer (NSCLC)
+- Glioblastoma
+- Metastatic Renal Cell Carcinoma (mRCC)
+- Persistent, Recurrent, or Metastatic Carcinoma of the Cervix
+- Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
+
","Targeted Cancer Therapy
","Bevacizumab binds VEGF and prevents the interaction of VEGF to its receptors (Flt-1 and KDR) on the surface of endothelial cells. The interaction of VEGF with its receptors leads to endothelial cell proliferation and new blood vessel formation in in vitro models of angiogenesis. Administration of bevacizumab to xenotransplant models of colon cancer in nude (athymic) mice caused reduction of microvascular growth and inhibition of metastatic disease progression.
","Metastatic Colorectal Cancer (mCRC): The recommended doses are 5 mg/kg or 10 mg/kg every 2 weeks when used in combination with intravenous 5-FU-based chemotherapy.
+
+- Administer 5 mg/kg when used in combination with bolus-IFL.
+- Administer 10 mg/kg when used in combination with FOLFOX4.
+- Administer 5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks when used in combination with a fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy regimen in patients who have progressed on a first-line Bevacizumab-containing regimen.
+
+
Non-Squamous Non-Small Cell Lung Cancer (NSCLC): The recommended dose is 15 mg/kg every 3 weeks in combination with carboplatin and paclitaxel.
Glioblastoma: The recommended dose is 10 mg/kg every 2 weeks.
Metastatic Renal Cell Carcinoma (mRCC): The recommended dose is 10 mg/kg every 2 weeks in combination with interferon alfa.
Cervical Cancer: The recommended dose of Bevacizumab is 15 mg/kg every 3 weeks as an intravenous infusion administered in combination with one of the following chemotherapy regimens: paclitaxel and cisplatin, or paclitaxel and topotecan.
Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer: The recommended dose is 10mg/ kg every 2 weeks in combination with one of the following intravenous chemotherapy regimens: paclitaxel, pegylated liposomal doxorubicin, or topotecan (weekly); or 15 mg/kg every 3 weeks in combination with topotecan (every 3 weeks).
","Do not administer as an intravenous push or bolus. Administer only as an intravenous (IV) infusion. Do not initiate Bevacizumab until at least 28 days following major surgery. Administer Bevacizumab after the surgical incision has fully healed.
First infusion: Administer infusion over 90 minutes. Subsequent infusions: Administer second infusion over 60 minutes if first infusion is tolerated; administer all subsequent infusions over 30 minutes if infusion over 60 minutes is tolerated.
","A drug interaction study was performed in which irinotecan was administered as part of the FOLFIRI regimen with or without Bevacizumab. The results demonstrated no significant effect of Bevacizumab on the pharmacokinetics of irinotecan or its active metabolite SN38.
In a randomized study in 99 patients with NSCLC, based on limited data, there did not appear to be a difference in the mean exposure of either carboplatin or paclitaxel when each was administered alone or in combination with Bevacizumab. However, 3 of the 8 patients receiving Bevacizumab plus paclitaxel/carboplatin had substantially lower paclitaxel exposure after four cycles of treatment (at Day 63) than those at Day 0, while patients receiving paclitaxel/carboplatin without Bevacizumab had a greater paclitaxel exposure at Day 63 than at Day 0.
","There are no contraindications listed in the manufacturer’s labeling.
","dry mouth, cough, voice changes, loss of appetite, diarrhea, nausea, vomiting, constipation, loss of appetite, mouth sores, headache, back , pain, cold symptoms (stuffy nose, sneezing, sore throat), dry or watery eyes, dry or flaky skin, hair loss, changes in your sense of taste, jaw pain/swelling/numbness, loose teeth, or gum infection.
","Pregnancy Category C. There are no adequate or well controlled studies of bevacizumab in pregnant women. It is not known whether Avastin is secreted in human milk.
","Arterial Thromboembolic Events. Among patients receiving Bevacizumab in combination with chemotherapy, the risk of developing ATE during therapy was increased in patients with a history of arterial thromboembolism, diabetes, or age greater than 65
","The safety, effectiveness and pharmacokinetic profile of Bevacizumab in pediatric patients have not been established. In published literature reports, cases of non-mandibular osteonecrosis have been observed in patients under the age of 18 years who have received Bevacizumab. Bevacizumab is not approved for use in patients under the age of 18 years.
Antitumor activity was not observed among eight children with relapsed glioblastoma treated with Bevacizumab and irinotecan. There is insufficient information to determine the safety and efficacy of Bevacizumab in children with glioblastoma.
","The highest dose tested in humans (20 mg/kg IV) was associated with headache in nine of 16 patients and with severe headache in three of 16 patients.
",,"Use appropriate aseptic technique. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Withdraw necessary amount of Bevacizumab and dilute in a total volume of 100 ml of 0.9% Sodium Chloride Injection, USP. Discard any unused portion left in a vial, as the product contains no preservatives.
","Bevacizumab vials are stable at 2 to 8° C. Bevacizumab vials should be protected from light. Do not freeze or shake. Diluted Bevacizumab solutions may be stored at 2 to 8° C for up to 8 hours. Store in the original carton until time of use. No incompatibilities between Bevacizumab and polyvinylchloride or polyolefin bags have been observed.
",14
+130,Betaxolol Hydrochloride,betaxolol-hydrochloride-130,https://medex.com.bd/attachments/bc5p9xihEZWEXFV2SFCSoIUqWprzTy/betaxolol-hydrochloride-ophthalmic-drops-revised-june-2007-prescribing-information,Drugs for miotics and glaucoma,Open angle glaucoma,"Betaxolol ophthalmic solution has been shown to be effective in lowering intraocular pressure and is indicated in the treatment of ocular hypertension and chronic open-angle glaucoma. May be used alone or in combination with other intraocular pressure-lowering medication.
","Drugs for miotics and glaucoma
","Betaxolol is a selective (beta-1-adrenergic) receptor blocking agent that does not have significant membrane stabilizing (local anesthetic) activity and is free from intrinsic sympathomimetic action. When instilled into the eye, Betaxolol reduces elevated as well as normal intraocular pressure, whether or not accompanied by glaucoma. Optic nerve head damage and visual field loss are results of a sustained elevated intraocular pressure and poor ocular perfusion. The ocular hypotensive action of Betaxolol appears to be mediated by a reduction of aqueous production as demonstrated by tonography and aqueous flurophotometry. Betaxolol ophthalmic solution does not produce miosis or accommodative spasm which is frequently seen with miotic.
The onset of action with Betaxolol can generally be noted within 30 minutes and the maximal effect can usually be detected two hours after topical administration. A single dose provides a 12-hour reduction in intraocular pressure (IOP) and twice daily administration maintains the IOP below 22 mm Hg in most patients.
","0.5% ophthalmic solution: The usual dose is 1 drop of Betaxolol Hydrochloride ophthalmic solution in the affected eye(s) twice daily. In some patients, the intraocular pressure-lowering response may require a few weeks to stabilize. Clinical follow-up should include a determination of the intraocular pressure during the first month of treatment. Thereafter, intraocular pressure should be determined on an individual basis at the judgment of the physician.
0.25% ophthalmic solution: The recommended dose is one to two drops of Betaxolol Hydrochloride ophthalmic solution in the affected eye(s) twice daily.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
",,"Patients who are receiving a beta-adrenergic blocking agent orally and Betaxolol Hydrochloride Ophthalmic Solution should be observed for a potential additive effect either on the intraocular pressure or on the known systemic effects of beta blockade. Close observation of the patient is recommended when a beta blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or bradycardia. Caution should be exercised in patients using concomitant adrenergic psychotropic drugs. In patients with angle-closure glaucoma, the immediate treatment objective is to reopen the angle by constriction of the pupil with a miotic agent. Betaxolol has little or no effect on the pupil. When Betaxolol Hydrochloride Ophthalmic Solution is used to reduce elevated intraocular pressure in angle-closure glaucoma, it should be used with a miotic and not alone.
","Hypersensitivity to any component of this product. Betaxolol should not be used in patients with sinus bradycardia, atrioventricular block greater than first degree, cardiogenic shock, or patients with a history of overt cardiac failure.
","Ocular: Discomfort of short duration, occasional tearing has been reported. Rare instances of decreased corneal sensitivity, erythema, itching sensation, corneal punctuate staining, keratitis, edema and photophobia have been reported.
Systemic: Systemic reactions following administration of Betaxolol hydrochloride ophthalmic solution 0.5% have been rarely reported. These include:
+
+- Cardiovascular: bradycardia, heart block, congestive heart failure.
+- Respiratory: bronchospasm, respiratory failure.
+- Others: Hives, toxic epidermal necrolysis, hair loss and glossitis.
+
","There are no adequate & well controlled studies in pregnant women. Betaxolol ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk. It is not known whether Betaxolol is excreted in human milk. The risk of hypoglycemia & bradycardia in nursing infant has not been evaluated. Breast feeding is not recommended during treatment.
","In patients with angle-closure glaucoma, the immediate treatment objective is to re-open the angle by constriction of the pupil with miotic agent. Betaxolol has no effect on the pupil; therefore, Betaxolol should be used with a miotic to reduce elevated intraocular pressure in angle-closure glaucoma. Beta-adrenergic blocking agents should be administered with caution in patients subjected to spontaneous hypoglycemia or to diabetic patients as these agents may mask the signs and symptoms of acute hypoglycemia.
",,"No information is available on overdosage. A topical overdosage of Betaxolol ophthalmic solution may be flushed from the eye(s) with warm tap water.
",,,"Store at room temperature. It is desirable that the content should not be used more than one month after first opening of the bottle.
",11
+1615,Betamethasone Valerate,betamethasone-valerate-1615,https://medex.com.bd/attachments/IEdHeoAYybMuk0E7xifvPrib1yb4Us/betamethasone-valerate-prescribing-information,Corticosteroid,Psoriasis,"Betamethasone Valerate cream or ointment is indicated for the treatment of-
+
+- Eczema in children and adults including atopic
+- Infantile and descoid eczema
+- Prurigo nodularis
+- Psoriasis (excluding wide spread plaque psoriasis)
+- Neurodermatoses including lichen simplex and lichen planus
... Read more
Betamethasone Valerate cream or ointment is indicated for the treatment of-
+
+- Eczema in children and adults including atopic
+- Infantile and descoid eczema
+- Prurigo nodularis
+- Psoriasis (excluding wide spread plaque psoriasis)
+- Neurodermatoses including lichen simplex and lichen planus
+- Seborrhoic dermatitis
+- Contact sensitivity reaction
+- Discoid lupus erythematoses and may be used as adjunct to systemic steroid therapy in generalized erythroderma.
+
","Corticosteroid
","Betamethasone Valerate BP is a synthetic adrenocorticosteroid, which is glucocorticoid in nature. It is an analog of prednisolone that also possesses a slight degree of mineral corticosteroid activity. Due to its anti-inflammatory, antipruritic and vasoconstrictive activity, it is very effective and suitable for dermatological use. It is absorbed from the skin and inflammation and/or another disease process in the skin increase percutaneous absorption from the skin. Occlusive dressings substantially increase its percutaneous absorption.
","Apply sparingly to the affected area two or three times daily until improvement occurs, then twice daily or less. The usual maximum duration of therapy is three weeks.
",,"There are no significant drug interactions reported with Betamethasone Cream/Ointment.
","Betamethasone Valerate cream or ointment is contraindicated in the following conditions :
+
+- Hypersensitivity to any of the ingredients in the preparation.
+- Rosaceae & acne vulgaris.
+- Perioral dermatitis, perianal & genital pruritis.
+- Viral infections of the skin, e.g. herpes simplex & chicken pox.
+- Primary infected skin lesions caused by fungi or bacteria.
+- Dermatoses in children under one year of age.
+
","The following local adverse reactions are more common with the use of high doses, long term use and with the use of occlusive dressings of Cream/Ointment: dryness, itching, burning, skin thinning, local irritation, features of hypercorticolism, telagiectasia, striaea, skin atrophy. hypertrichosis, change in pigmentation, secondary infection, perioral dermatiis, allergic contact dermatitis, maceration of the skin, acneform eruption, exacerbation of symptoms.
","It should not be used extensively in pregnancy.
","Betamethasone Cream/Ointment is usually well tolerated but if signs of hypersensitivity appear, application should be stopped. Long term continuous topical therapy should be avoided where possible, particularly in children as adrenal suppression may occur even without occlusion. When extensive areas are treated, sufficient systemic absorption may occur to produce symptoms of hypercorticolism. This effect is more likely if occlusive dressings are used, or if the treatment is prolonged. The face or other areas of the body may exhibit atrophic changes after prolonged treatment. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result. Any spread of the infection requires withdrawal of topical corticosteroid therapy.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+1616,Betamethasone Sodium Phosphate,betamethasone-sodium-phosphate-1616,https://medex.com.bd/attachments/fXVcRKkuveZBotpUvo2JEZGvoHSytv/betamethasone-sodium-phosphate-prescribing-information,Corticosteroid,Ocular infections,"Short-term treatment of steroid responsive in inflammatory conditions of the eye after clinical exclusion of bacterial, viral or fungal infections. Non-infected inflammatory conditions of the ear or nose.
","Corticosteroid
","Corticosteroids bind to the glucocorticoid receptor, inhibiting pro-inflammatory signals, and promoting anti-inflammatory signals. Betamethasone phosphate has a short duration of action as it is rapidly hydrolyzed to betamethasone. Corticosteroids have a wide therapeutic window as patients may require doses that are multiples of what the body naturally produces. Patients taking corticosteroids should be counselled regarding the risk of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections.
","Eye: 1 or 2 drops to each affected eye every 1 or 2 hours until control is achieved, then the frequency may be reduced.
Ear: 2 or 3 drops to each affected ear every 2 or 3 hours until control is achieved, then the frequency may be reduced.
Nose: 2 or 3 drops instilled into each nostril 2 or 3 times daily.
",,"Specific drug interaction studies have not been conducted.
",,"Hypersensitivity reactions may occur leading to irritation, burning, stinging, itching and dermatitis. Topical corticosteroid use may result in corneal ulceration, increased intraocular pressure leading to optic nerve damage, reduced visual acuity. Intensive or prolonged use of topical corticosteroids may lead to formation of posterior subcapsular cataracts. In those diseases causing thinning of the cornea or sclera, corticosteroid therapy may result in thinning of the globe leading to perforation. Mydriasis, ptosis and epithelial punctate keratitis have also been reported following ophthalmic use of corticosteroids.
","There are no adequate and well controlled studies for pregnant woman. It should not be used extensively in pregnant woman. There is no information available whether it is secreted in the milk or not.
","Topical corticosteroids should never be given for an undiagnosed red eye. Ophthalmic treatment with corticosteroid preparations should not be repeated or prolonged without regular review to exclude raised intraocular pressure, cataract formation or unsuspected infections.
",,"Long-term intensive topical use may lead to systemic effects.
",,,"This should be protected from light, store below 25°C. Keep out of reach of children. Do not use more than 4 weeks after opening.
",10
+1189,Betamethasone Dipropionate + Salicylic Acid,betamethasone-dipropionate-salicylic-acid-1189,https://medex.com.bd/attachments/F24HVDsdcBUG8eHlBBAxRYofXN8o47/betamethasone-dipropionate-salicylic-acid-prescribing-information,Topical anti-inflammatory preparations,Seborrhea,"This Scalp preparation is used to treat inflammatory, dry and scaly skin disorders, such as Eczema, Psoriasis.
","Topical anti-inflammatory preparations
","Betamethasone Dipropionate is a glucocorticoid which have primarily anti-inflammatory and immunosuppressive effects and Salicylic Acid which has keratolytic properties and is applied topically in the treatment of hyperkeratotic. Keratolytic action helps to facilitate the penetration of the corticosteroids easily and Betamethasone Dipropionate is an effective treatment of dermatoses because of their anti-inflammatory, antipruritic and vasoconstrictive actions.
","Scalp Ointment-
+
+- Adults: Once twice daily. In most cases, the ointment should be applied to the affected area twice daily for two weeks and is reviewed at that time. The maximum weekly dose should not exceed 60 gm.
+- Children: Dosage in children should be limited to 5 days.
+
+
Scalp Lotion-
+
+- Apply few drops of this scalp lotion to the affected area and massage gently and thoroughly onto the scalp or skin. The usual frequency of application is twice daily, in the morning and at night.
+
",,"If other drugs or over-the-counter products use at the same time, this may increase the side effects or cause drug not to work properly. This Scalp preparation may interact with the following products such as Acetaminophen, Atropine, Carbonic anhydrase inhibitors, Chlorpropamide, Glucocorticoids.
","Contraindicated to the hypersensitivity to any of the ingredients of this Scalp preparation. Also contraindicated to use in tuberculosis and most viral lesions of the skin, particularly herpes simplex, vacinia, varicella. This Scalp preparation should not be used in fungal or bacterial skin infections.
","Side effects that have been reported with the application of topical corticosteroids include burning, itching, irritation, dryness, hypopigmentation, perioral dermatitis and allergic contact dermatitis.
","It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and should not be used for prolonged periods of time in pregnant patients. It is not known this drug is secreted in human milk.
","These drugs should not be used in or near the eyes. This Scalp preparation should not be used in various skin infections (Bacterial, Viral or Fungal). If irritation and sensitization develop with the use of this Scalp preparation, treatment should be discontinued. Application of Salicylic Acid to open wounds or damaged skin should be avoided. Long-term continuous therapy should be avoided in all patients irrespective of age.
",,,,,"Store in a cool & dry place, protected from light and keep out of the reach of children.
",10
+123,Betamethasone Dipropionate,betamethasone-dipropionate-123,https://medex.com.bd/attachments/u46pz006PNU0Ly8tBTQlLsjynArnn7/betamethasone-dipropionate-prescribing-information,Corticosteroid,Ulcerative colitis,"Betamethasone Dipropionate cream and ointment is
indicated for the relief of the inflammatory and pruritic manifestations of resistant or severe corticosteroid-responsive dermatoses. These include-
+
+- Atopic eczema
+- Nummular eczema
+- Contact dermatitis
+- Neurodermatitis
+- Anogenital and senile pruritus
+- Lichen planus
+- Psoriasis
+
","Corticosteroid
","Betamethasone Dipropionate is a topical corticosteroid with anti-inflammatory, antipruritic and vasoconstrictive properties. Betamethasone Dipropionate induces peptides called lipocortins. Lipocortins antagonize phospholipase A2, an enzyme that causes the breakdown of leukocyte lysosomal membranes to release arachidonic acid. This action decreases the subsequent formation and release of endogenous inflammatory mediators including prostaglandins, kinins, histamine.
Pharmacokinetics: Betamethasone Dipropionate can be absorbed from normal intact skin. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver.lt excreted by the kidneys.
","Apply a thin film once or twice daily to cover completely the affected area. Patients with chronic psoriasis who have achieved at least a marked improvement in their psoriatic lesion (i.e., approximately 80% improvement) with Betamethasone Dipropionate may be maintained in remission with a pulse dosing regimen consisting of three consecutive applications of up to 3.5 g each of Betamethasone Dipropionate cream and ointment, twelve hours apart (e.g., morning, evening, following morning) to the previously affected areas once each week. For this purpose, Betamethasone Dipropionate cream and ointment should be applied to the lesion sites previously affected and treated. Patients on this pulse dose regimen who relapse should be reverted back to the conventional dosing regimen.
",,"There is no evidence of any kind of interaction.
","Hypersensitivity to Betamethasone Dipropionate, other corticosteroids or any components in this preparation. Like other topical corticosteroids, Betamethasone Dipropionate is contraindicated in viral infections of the skin, such as vaccinia, varicella and Herpes simplex, also tuberculosis, acne rosacea, fungal skin infections (moniliasis), perioral dermatitis and ulcerative conditions.
","The most frequent side effects reported with Betamethasone Dipropionate are mild to moderate transient burning/stinging, dry skin, pruritus, irritation and folliculitis. Rarely reported adverse effects include tingling, prickly skin/tightening or cracking of skin, warm feeling,laminar scaling and perilesional scaling,follicular rash, skin atrophy, erythema, urticaria, vesiculation, telangiectasia, acneiform papules and hyperaesthesia.
Adverse reactions reported with the use of the Betamethasone Dipropionate ointment pulse dose regimen were mild intermittent hypertension and paraesthesia. Other local adverse reactions that have been reported with the use of topical corticosteroids include: itching, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, striae, miliaria and exacerbation of untreated infections
",,"Betamethasone Dipropionate should not be used in or near the eyes, as there is a potential risk of developing glaucoma and cataract. If irritation or sensitisation develops with the use of Betamethasone Dipropionate, treatment should be discontinued and appropriate therapy instituted. In the presence of an infection, an appropriate antifungal or antibacterial agent should be administered. If a favourable response does not occur promptly, Betamethasone Dipropionate should be discontinued until the infection has been controlled adequately.
Corticosteroids are known to be absorbed percutaneously, therefore in patients under prolonged and extensive topical treatment, the possibility of systemic effects should be kept in mind. Betamethasone Dipropionate is not intended for use under occlusive dressings since this will also increase systemic absorption of the corticosteroid. In infants the napkin may act as an occlusive dressing and increase absorption. Suitable precautions should be taken when using topical corticosteroids in patients with stasis dermatitis and other skin diseases with impaired circulation. Prolonged use of topical corticosteroid preparations may produce striae or atrophy of the skin or subcutaneous tissue. If this occurs, treatment should be discontinued.
",,"Acute overdose with the ointment is unlikely and would not be expected to lead to a life-threatening situation. The ointment should not be used for longer than the prescribed time period.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+1226,Betamethasone + Neomycin Sulphate (Topical),betamethasone-neomycin-sulphate-topical-1226,https://medex.com.bd/attachments/qoiM0L2zK3LhGz5McaW1zw2g78R8KD/betamethasone-neomycin-sulphate-topical-prescribing-information,Aural steroid & antibiotic combined preparations,Systemic lupus erythematosus (SLE),"This cream is usually useful for the treatment of superficial infections caused by gram-positive and gramnegative microorganisms. It is also useful in burns, regeneration of new skin in wounds and ulceration, otitis externa, postoperative infections, neuro-dermatitis and eczema. It may be used as an adjunct to systemic steroid therapy in special kind of pyoderma.
","Aural steroid & antibiotic combined preparations
","Betamethasone is an active topical corticosteroid, which produces a rapid response in the inflammatory dermatoses and cures psoriasis types of skin diseases. Neomycin Sulfate is a topical broad-spectrum bactericidal amino-glycoside effective against various kinds of gram-positive and gramnegative pathogens such as Proteus vulgaris, Staphylococcus aureus etc. This preparation has effective penetration and uniform distribution capacity, so it is very effective in hairy and intertriginous places. This preparation is very effective for the treatment of wet ulceration of the skin.
","Use in adults: This preparation should be applied to the affected parts of the skin as a thin layer for 3 to 4 times daily. In chronic conditions, withdrawal of treatment is carried out by decreasing the frequency of application until the cream is applied as infrequently as once a week. Or as directed by the physician.
Use in children: Do not use it on children under 1 year of age. A course of treatment for a child should not normally last more than 5 days unless otherwise stated by your physician.
",,"There are no significant drug interactions reported with Betamethasone Valerate BP and Neomycin Sulphate BP Cream/Ointment.
","This preparation is contraindicated to the patients who are hypersensitive to any of its components. It should not be used for the treatment of otitis externa when the eardrum is perforated. It is contraindicated in skin lesions caused by infection with viruses and fungi.
","This preparation is well tolerated. But prolonged and high doses may cause Cushing's syndrome, acne, thinning and dilatation of blood vessels, particularly when occlusive dressings are used.
","This preparation should not be used extensively in pregnancy.
","Long term continuous topical therapy of this preparation should be avoided, which may produce many resistant micro organisms. So, accurate dose of this preparation should be used in infected areas only.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+1164,Betamethasone + Phenylephrine + Lignocaine,betamethasone-phenylephrine-lignocaine-1164,,Phlebotonic & Vascular protecting preparation,Piles,"Local anorectal conditions like haemorrhoids and fissures where, there is inflammation & pain.
","4-Quinolone preparations, Phlebotonic & Vascular protecting preparation
","Betamethasone is a corticosteroid with mainly glucocorticoid activity. It induces phospholipase A2 inhibitory lipase (lipocortins) and sequentially inhibits the release of arachidonic acid, thereby depressing the formation, release, and activity of prostaglandins, leukotrienes, and other inflammatory mediators.
Phenylephrine is a sympathomimetic with mainly direct effects on alpha-adrenergic receptors and weak beta-adrenergic activity. It causes vasoconstriction of the arterioles of the nasal mucosa and conjunctiva; activates the dilator muscle of the pupil to cause contraction; produces vasoconstriction of arterioles in the body and produces systemic arterial vasoconstriction.
Lidocaine alters signal conduction in neurons by blocking the fast voltage-gated Na+ channels in the neuronal cell membrane responsible for signal propagation. With sufficient blockage, the membrane of the postsynaptic neuron will not depolarize and will thus fail to transmit an action potential.
","Apply locally 2 or 3 times daily initially, using the applicator if internal administration is required, When inflammation is subsiding once-daily application is sufficient in most cases,
",,"Not known
","Topical corticosteroids are contraindicated in: Primarily infected skin lesions caused by viral infections e.g herpes simplex, vaccinia or varicella (chicken pox), by bacteria e.g impetigo, by fungal infections e.g candidiasis, tineasis or by tuberculous infection of the anal region; Sensitivity to any of the components of the product; Dermatoses in children under 1 year of age.
","As with all topical corticosteroids, its use for prolonged periods, may cause systemic absorption, specially in children. Prolonged and intensive treatment with active corticosteroid preparations may also cause local atrophic changes in the skin. There are reports of pigmentation changes and hypertrichosis with topical steroids, and in this situation it should be discontinued. Some patients may experience burning upon application, specially if the mucous membrane is not intact.
","The safe use of topical corticosteroids in human pregnancy has not been fully established. Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intrauterine growth retardation.
Therefore, there may be a very small risk of such effects in the human fetus. So, it should not be used unnecessarily in large amounts or for prolonged period.
","Long-term continuous treatment should be avoided. Discontinue if sensitization occurs.
",,,,,,9
+124,Betamethasone + Neomycin Sulphate (E/E),betamethasone-neomycin-sulphate-ee-124,https://medex.com.bd/attachments/O0SOH2sql3T1DxZnvigdIJxms6X6Pj/betamethasone-neomycin-sulphate-ee-prescribing-information,Ophthalmic steroid - antibiotic combined preparations,Uveitis,"Eye: Inflammatory conditions (eg. uveitis, marginal keratitis, allergic conjunctivitis, blepharitis and episcleritis) where development of bacterial infection is likely.
Ear: Otitis externa and other inflammatory conditions where bacterial infection is present ... Read more
Eye: Inflammatory conditions (eg. uveitis, marginal keratitis, allergic conjunctivitis, blepharitis and episcleritis) where development of bacterial infection is likely.
Ear: Otitis externa and other inflammatory conditions where bacterial infection is present or suspected.
Nose: Inflammatory conditions where infection is present or suspected.
","Ophthalmic steroid - antibiotic combined preparations
","Betamethasone is a corticosteroid which is effective in inflammatory dermatoses. It is also effective in less responsive conditions such as psoriasis. Betamethasone has a 16β-methyl group that enhances the anti-inflammatory action of the molecule and reduces the sodium and water retaining properties of the fluorine atom bound at carbon 9.
Neomycin sulfate is bactericidal against many bacteria which are commonly associated with skin infections. Neomycin is a broad spectrum antibiotic which actively transported across the bacterial cell membrane, binds to a specific receptor protein on the 30s subunit of bacterial ribosomes, and interferes with an initiation complex between mRNA (messenger RNA) and the 30s subunit, inhibiting protein synthesis. DNA may be misread, thus producing nonfunctional proteins; polyribosomes are split apart and are unable to synthesize protein.
","Drops:
+
+- Eye: 1 drop instilled into the eye every one or two hours until control is achieved, when the frequency may be reduced.
+- Ear: 2 or 3 drops instilled into the ear, every two or three hours until control is achieved, when the frequency can be reduced.
+- Nose: 2 or 3 drops instilled into each nostril two or three times daily.
+
+
Eye Ointment: It should be applied thinly and evenly to the conjunctival sac at night (If eye drops used during day) or 3-4 times daily (if ointment used alone).
",,,"Viral, fungal, tuberculous or purulent conditions. Use in the eye is contra-indicated if glaucoma is present or where herpetic keratitis (e.g. dendritic ulcer) is considered a possibility. Inadvertent use of topical steroids in the latter condition can lead to extension of the ulcer and marked visual deterioration. Preparations containing neomycin should not be used for treating otitis externa when the ear drum is perforated, because of the risk of ototoxicity.
","Acute sensitization to neomycin is a rare event but can occur after topical application to the eye. Eye drops containing corticosteroids cause a serious rise in intra-ocular pressure in a small percentage of the population, including most of those with a family history of glaucoma. A milder rise may be experienced by a larger proportion of subjects if treatment is continued for longer than a few weeks. Thinning of the cornea leading to perforation has occurred with use of topical corticosteroids. Cataract is reported to have occurred after unduly prolonged treatment of eye conditions with topical corticosteroids.
","Pregnancy Category-Not Classified. FDA has not yet classified the drug into a specified pregnancy category. Topical administration of corticosteroid to pregnant animals can cause abnormalities of fetal development. The relevance of this finding to human beings has not been established; however, topical steroids should not be used extensively in pregnancy, i.e. in large amounts or for prolonged periods.
","Steroids should not be administered to ""red eyes"" until a definitive diagnosis has been made. Ophthalmological treatment with steroid preparations should not be repeated or prolonged without regular review to exclude raised intra-ocular pressure or unsuspected infections. The unnecessary topical use of neomycin containing products should be avoided in order to minimize the occurrence of neomycin-resistant organisms (and organism cross-resistant to other aminoglycosides).
",,,,,"Store below 25° C
",9
+1242,Betamethasone + Gentamicin,betamethasone-gentamicin-1242,,Other Topical corticosteroids,Psoriasis,"The topical treatment of corticosteroid responsive dermatoses when complicated by secondary infection caused by organisms sensitive to gentamicin or when the possibility of such infection is suspected. The cream is recommended for wet, oozing primary infections, and greasy, secondary infections such ... Read more
The topical treatment of corticosteroid responsive dermatoses when complicated by secondary infection caused by organisms sensitive to gentamicin or when the possibility of such infection is suspected. The cream is recommended for wet, oozing primary infections, and greasy, secondary infections such as pustular acne or infected seborrheic dermatitis. The ointment helps retain moisture and has been useful in infection on dry eczematous or psoriatic skin.
","Other Topical corticosteroids
","Betamethasone dipropionate with gentamicin combines the anti-inflammatory, antipruritic and vasoconstrictive activity of a synthetic corticosteroid, betamethasone dipropionate, with the broad spectrum anti-bacterial effect of gentamicin.
In secondary skin infections, gentamicin facilitates the treatment of the underlying dermatosis by controlling the infection. Bacteria susceptible to the action of gentamicin include sensitive strains of streptococci (group A beta hemolytic, alpha hemolytic), S. aureus (coagulase positive, coagulase negative, and some penicillinase producing strains), and the gram-negative bacteria P. aeruginosa, E. aerogenes, E. coli, Proteus (both indole positive and indole negative), K. pneumoniae, and S. marcescens.
This cream is slightly acidic so that it is within the pH range of the normal skin. On application, it leaves minimum residue without stickiness or greasiness. The presence of petrolatum in both cream and ointment offers lubricating qualities and helps to prevent excessive drying.
","A sufficient quantity of the cream or ointment should be applied to cover completely the affected area and should be massaged gently and thoroughly into the skin. The usual frequency of application is twice daily although some patients may be maintained adequately with less frequent application.
",,,"Viral diseases including vaccinia, varicella, herpes simplex, fungal infections, tuberculosis of the skin and hypersensitivity to any of the components.
","The following local adverse skin reactions have been reported with the use of topical steroids: dryness, itching, burning, local irritation, striae, skin atrophy, hypertrichosis, change in pigmentation and secondary infection. Adrenal suppression has also been reported following topical corticosteroid therapy. Posterior subcapsular cataracts have been reported following systemic use of corticosteroids..
","Since safety of topical corticosteroid use in pregnant women has not been established, drugs of this class should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively in large amounts or for prolonged periods of time in pregnant patients. Since it is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk, a decison should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. This drug should not be used in or near the eyes since the vehicle is not formulated for ophthalmic use.
","Gentamicin is not effective against fungi, yeasts or viruses. Patients with superficial fungus or yeast infections also must receive specific therapy and the use of the drug may have to be discontinued. The use of such topical preparations may result in an overgrowth of non-susceptible organisms.
Suitable precautions should be taken in using topical corticosteroids in patients with stasis dermatitis and other skin diseases with impaired circulation.
Prolonged use of corticosteroid preparations may produce striae or atrophy of the skin or s.c. tissue. If this occurs, treatment should be discontinued.
Causal factors should be sought and eliminated whenever possible and the sensitivity of an infecting organism to gentamicin should be verified.
Patients should be advised to inform subsequent physicians of the prior use of corticosteroids.
While no systemic effects have been observed following the topical application of gentamicin, toxic systemic concentrations can cause permanent impairment of vestibular function in the presence of renal insufficiency or existing 8th cranial nerve damage.
Caution should be exercised if gentamicin is used in individuals who are known to be sensitive to topically applied antibacterials. If irritation or sensitization develops, treatment should be discontinued.
Application over extensive lesions may result in significant systemic absorption producing hypercortisonism manifesting itself by adrenal suppression, moon face, striae and suppression of growth in children.
Patients should be followed up regularly, and the product should be discontinued when the infection has cleared.
Occlusive dressing should not be used.
",,"Symptoms: Excessive prolonged use of topical corticosteroids can suppress pituitary-adrenal function leading to secondary adrenal insufficiency.
Treatment: Correct electrolyte imbalance, if needed. Slow withdrawal of corticosteroids may be needed.
",,,"Store between 2-30° C.
",10
+127,Betamethasone + Clotrimazole,betamethasone-clotrimazole-127,https://medex.com.bd/attachments/cOExt18rVTVETybg6MG5Yn15iQbr4L/betamethasone-clotrimazole-revised-may-2018-prescribing-information,Betamethasone & Combined preparations,Tinea corporis (ringworm),"This topical preparation is indicated for the topical treatment of inflammatory dermal infections like-
+
+- Tinea pedis
+- Tinea cruris
+- Tinea corporis etc.
+
","Betamethasone & Combined preparations
","Clotrimazole is a broad-spectrum antifungal agent used for the treatment of superficial infections caused by species of pathogenic dermatophytes, yeasts and Malassezia furfur. The mechanism of action involves inhibition of the synthesis of ergosterol, a major sterol in the fungal cell membrane. This leads to instability of the cell membrane and eventual death of the fungus. Betamethasone dipropionate is a corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. But the exact mechanism of action of corticosteroids is not clearly known.
","Sufficient topical preparation should be applied onto the affected and surrounding skin areas twice a day, in the morning and evening, for 2 weeks in tinea cruris and tinea corporis and for 4 weeks in tinea pedis. The use of this cream for longer than four weeks is not recommended.
The safety and effectiveness of the preparation have not been established in children below the age of 12 years.
",,"No information is available of drug interaction.
","This topical preparation is contraindicated to those patients who are sensitive to any of its components or to other corticosteroids or to imidazoles. If irritation or sensitization develops with the use of the cream, treatment should be discontinued and appropriate therapy instituted. The cream is contraindicated in facial rosacea, acne vulgaris, perioral dermatits, perianal and genital pruritus, napkin eruptions and bacterial or viral infections. Systemic absorption of topical corticosteroides can produce reversible hypothalmic-pituitary-adrenal (HPA) axis suppression. If HPA axis suppression is noted, an attempt should be made to withdraw the drug or to reduce the frequency of application. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their large skin surface to body mass ratios.
","Adverse reactions reported for the preparation in clinical trials were paresthesia in 1.9% of patients, rash, edema and secondary infection, each in less than 1% of patients. Other adverse reactions reported with the preparation were burning and dry skin in 1.6% of patients and stinging in less than 1% of patients
","There is inadequate evidence of safety in pregnancy. Clotrimazole has no teratogenic effect in animals but is foetotoxic at high oral doses. Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development. Hence the cream should only be used in pregnancy if the benefit justifies the potential risk to the fetus and such use should not be extensive,i.e. in large amounts or for long periods. It is not known whether the components of the preparation are excreted in human milk and therefore caution should be exercised when treating nursing mothers.
",,,"Acute overdose with the cream is unlikely and would not be expected to lead to a life-threatening situation. The cream should not be used for longer than the prescribed time period.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+125,Betamethasone + Clotrimazole + Gentamicin,betamethasone-clotrimazole-gentamicin-125,https://medex.com.bd/attachments/o5tDNmdp8Qm0I5kXXyhei2VNKLYuvP/betamethasone-clotrimazole-gentamicin-prescribing-information,Betamethasone & Combined preparations,Urticaria,"This Cream is indicated for the treatment of corticosteroid-responsive dermatoses when complicated by infections caused by bacteria and fungi. This is also effective in the treatment of tinea pedis, tinea cruris & tinea corporis, acute and chronic eczema.
","Betamethasone & Combined preparations
","This Cream combines the anti-inflammatory, antipruritic and vasoconstrictive actions of Betamethasone Dipropionate with the broad spectrum antifungal activity of Clotrimazole and the wide-spectrum bactericidal antibiotic activity of Gentamicin Sulfate. Clotrimazole appears to act on the fungal cell membrane, causing leakage of cell contents. Gentamicin provides highly effective topical treatment in primary and secondary bacterial infections of the skin.
","Apply gently into the affected skin areas twice daily. Duration of therapy varies depending upon the extent and location of disease and patient response. For effective treatment, This Cream should be applied regularly.
",,"Concomitant use with nephrotoxic drugs including other aminoglycosides, vancomycin and some of cephalosporins; or ototoxic drugs such as ethacrynic acid and furosemide may increase the risk of toxicity.
","This Cream is contraindicated in those patients with a history of sensitivity reactions to any of its components.
","Adverse reactions have been reported very rarely and include hypochromia, burning, erythema, exudation etc.
","Since safety of topical corticosteroid in pregnant women has not been established, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
A decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the lactating mother.
","Do not combine with any other product containing corticosteroid. Not for application to the face, avoid contact with eyes. Not for prolonged use or use in extensive areas, under an occlusive dressing, open wound, injured areas, exterior genital areas and skin folds.
",,,,,,9
+1600,Benzalkonium chloride,benzalkonium-chloride-1600,,Bleaching and Disinfectants,Topical antiseptic,"Higher concentrations of Benzalkonium chloride is used as an antiseptic and disinfectant. This is also widely used as a preservative in eye-drops.
","Bleaching and Disinfectants
","Benzalkonium chloride is a quaternary ammonium antiseptic and disinfectant. It is also used as an antimicrobial preservative for pharmaceutical products. It is also used for the disinfection of rigid contact lenses.
","
+- Tincture of benzalkonium chloride 1:750 is used for the preoperative disinfection of unbroken skin or treatment of superficial injuries.
+- For preoperative disinfection of mucous membranes and denuded skin, benzalkonium chloride solution in concentrations of 1:10000 to 1:2000 is used.
+- For irrigation of the eye, a solution of 1:10000 to 1:5000 is used.
+- For urinary bladder and urethral irrigation, a solution 1:5000 to 1:20000 is used.
+- For vaginal douche and irrigation, benzalkonium chloride solution 1:5000 to 1:20000.
+
",,"Disinfectants containing quaternary ammonium salts should not be used for skin preparation before injections of viscoelastic solutions. Hyaluronic acid will precipitate in the presence of these salts.
","Incompatible with soaps and other anionic surfactants, citrates, iodides, nitrates, permanganates, salicylates, silver salts, tartrates, and zinc oxide and sulfate.
","Repeated application may cause hypersensitivity reactions. May cause nausea and vomiting if ingested.
",,,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",8
+1288,Bendamustine,bendamustine-1288,https://medex.com.bd/attachments/dRgT50icwiBUikg6TEyhuSoqqPfzon/bendamustine-revised-15-september-2016-prescribing-information,Cytotoxic Chemotherapy,Non-Hodgkin lymphoma,"Chronic Lymphocytic Leukemia (CLL): Bendamustine is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established.
Non-Hodgkin Lymphoma (NHL): Bendamustineis ... Read more
Chronic Lymphocytic Leukemia (CLL): Bendamustine is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established.
Non-Hodgkin Lymphoma (NHL): Bendamustineis indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
Also indicated in Multiple myeloma.
","Cytotoxic Chemotherapy
","Bendamustine is a bifunctional mechlorethamine derivative capable of forming electrophilic alkyl groups that covalently bond to other molecules. Through this function as an alkylating agent, bendamustine causes intra- and inter-strand crosslinks between DNA bases resulting in cell death. It is active against both active and quiescent cells, although the exact mechanism of action is unknown.
","Chronic lymphocytic leukaemia: 100 mg/m2 infused over 30-60 min on days 1 and 2 of a 28-day cycle for up to 6 cycles. For severe haematological or non-haematological toxicity: Reduce dose to 50 mg/m2 on days 1 and 2 of each cycle. If severe haematological toxicity recurs, further reduce dose to 25 mg/m2 on days 1 and 2 of each cycle. May consider dose re-escalation in subsequent cycles.
Multiple myeloma: 120-150 mg/m2 infused over 30-60 min on days 1 and 2 of a 28-day cycle. IV or oral prednisone may be given at a dose of 60 mg/m2 on days 1-4 of the cycle.
Non-Hodgkin's lymphoma: 120 mg/m2 infused over 30-60 min on days 1 and 2 of a 21-day cycle for up to 8 cycles. For severe haematological or non-haematological toxicity: Reduced to 90 mg/m2 on days 1 and 2 of each cycle. If severe toxicity recurs, further reduce dose to 60 mg/m2 on days 1 and 2 of each cycle.
",,"May increase plasma levels with CYP1A2 inhibitors (e.g. ciprofloxacin, fluvoxamine). May reduce plasma levels with CYP1A2 inducers (e.g. omeprazole and tobacco smoking).
","Patient with history of hypersensitivity (e.g. anaphylaxis and anaphylactoid reactions); jaundice, severe bone marrow suppression, low leukocyte or platelet count. Severe hepatic impairment. Major surgery <30 days prior to treatment.
","Malignant and pre-malignant disease; pyrexia, nausea, vomiting, cough, headache, fatigue, diarrhoea, constipation, anorexia, wt decrease, rash, stomatitis, lymphopenia, anaemia, thrombocytopenia, leucopenia, neutropenia.
","Pregnancy category D. There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Mild to moderate hepatic and renal impairment. Pregnancy and lactation.
","Hepatic Impairment: Moderate: Reduce dose by 30%.
","Symptoms: Cardiotoxicity, thrombocytopenia.
Management: May perform bone marrow transplantation and transfusions to control haematological effects. It is dialysable to a small extent.
",,"Reconstitute powder for inj by adding 5 ml or 20 ml of sterile water for inj to a vial containing 25 mg or 100 mg, respectively to provide a soln containing 5 mg/ml. The lyophilised powder should be dissolved w/in 5 min, shake well to facilitate dissolution. within 30 min of reconstitution, the appropriate volume should be withdrawn from the vial to further dilute in 500 ml of either NaCl 0.9% inj or dextrose 2.5% and NaCl 0.45% inj to a final concentration of 0.2-0.6 mg/ml.
","Store below 25° C, prior to reconstitution. Protect from light.
",13
+1713,Saffron + Mace arillus + Nutmeg fruit,saffron-mace-arillus-nutmeg-fruit-1713,,Herbal and Nutraceuticals,Premature ejaculation,"
+- Nishat increases libido.
+- Nishat is a natural aphrodisiac.
+- Nishat prevents premature ejaculation.
+- Nishat maintains youthful vigour.
+- Nishat helps retentive power.
+- Nishat ensures pleasant orgasm & post coitus freshness.
+- Nishat relieves physical & mental exhaustion.
+
","Herbal and Nutraceuticals
","Nishat is a unique natural aphrodisiac capsule for youthful vigour and vitality. By virtue of extensive research in Hamdard Laboratories, the unique formulation of Nishat has been developed especially for increasing libido, elevating mood and mental freshness.
","1-2 capsule(s) to be taken with milk 2 hours before coitus or as prescribed by the physician.
",,,"It is contraindicated for children.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place protect from light.
",8
+1967,Bempedoic acid,bempedoic-acid-1967,https://medex.com.bd/attachments/idR2Rst23wU1Eaa2mQ6pbBTR4sgqq4/bempedoic-acid-prescribing-information,,,"Bempedoic acid is an adenosine triphosphate-citrate lyase (ACL) inhibitor indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.
",,"Bempedoic acid is an adenosine triphosphate-citrate lyase (ACL) inhibitor that lowers low-density lipoprotein cholesterol (LDL-C) by inhibition of cholesterol synthesis in the liver. ACL is an enzyme upstream of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase in the cholesterol biosynthesis pathway. Bempedoic acid and its active metabolite, ESP15228, require coenzyme A (CoA) activation by very long-chain acyl-CoA synthetase 1 (ACSVL1) to ETC-1002-CoA and ESP15228-CoA, respectively. ACSVL1 is expressed primarily in the liver. Inhibition of ACL by ETC-1002-CoA results in decreased cholesterol synthesis in the liver and lowers LDL-C in blood via upregulation of low-density lipoprotein receptors.
","The recommended dosage of Bempedoic acid, in combination with maximally tolerated statin therapy, is 180 mg administered orally once daily. Bempedoic acid can be taken with or without food. After initiation of Bempedoic acid, analyze lipid levels within 8 to 12 weeks.
",,"Simvastatin: Avoid concomitant use of Bempedoic Acid with simvastatin greater than 20 mg. Pravastatin: Avoid concomitant use of Bempedoic Acid with pravastatin greater than 40 mg.
",,"
+- Upper respiratory tract infection
+- Muscle spasms
+- Hyperuricemia
+- Back pain
+- Abdominal pain or discomfort
+- Bronchitis
+- Pain in extremity
+- Anemia
+- Elevated liver enzymes
+
","Discontinue Bempedoic Acid when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. There are no available data on Bempedoic Acid use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There is no information regarding the presence of Bempedoic Acid in human or animal milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Breastfeeding is not recommended during treatment with Bempedoic Acid.
","Bempedoic acid inhibits renal tubular OAT2 and may increase blood uric acid levels. In clinical trials, 26% of Bempedoic acid-treated patients with normal baseline uric acid values (versus 9.5% placebo) experienced hyperuricemia one or more times, and 3.5% of patients experienced clinically significant hyperuricemia reported as an adverse reaction (versus 1.1% placebo). Increases in uric acid levels usually occurred within the first 4 weeks of treatment initiation and persisted throughout treatment. After 12 weeks of treatment, the mean placebo-adjusted increase in uric acid compared to baseline was 0.8 mg/dL for patients treated with Bempedoic acid.
Elevated blood uric acid may lead to the development of gout. Gout was reported in 1.5% of patients treated with Bempedoic acid and 0.4% of patients treated with placebo. The risk for gout events was higher in patients with a prior history of gout (11.2% Bempedoic acid versus 1.7% placebo), although gout also occurred more frequently than placebo in patients treated with Bempedoic acid who had no prior gout history (1.0% Bempedoic acid versus 0.3% placebo). Advise patients to contact their healthcare provider if symptoms of hyperuricemia occur. Assess serum uric acid when clinically indicated. Monitor patients for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.
Tendon Rupture: Bempedoic acid is associated with an increased risk of tendon rupture or injury. In clinical trials, tendon rupture occurred in 0.5% of patients treated with Bempedoic acid versus 0% of placebo-treated patients and involved the rotator cuff (the shoulder), biceps tendon, or Achilles tendon. Tendon rupture occurred within weeks to months of starting Bempedoic acid. Tendon rupture may occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders.
Discontinue Bempedoic acid immediately if the patient experiences rupture of a tendon. Consider discontinuing Bempedoic acid if the patient experiences joint pain, swelling, or inflammation. Advise patients to rest at the first sign of tendinitis or tendon rupture and to contact their healthcare provider if tendinitis or tendon rupture symptoms occur. Consider alternative therapy in patients with a history of tendon disorders or tendon rupture.
","Pediatric Use: The safety and effectiveness of Bempedoic acid have not been established in pediatric patients.
Geriatric Use: Of the 3009 patients in clinical trials of Bempedoic acid, 1753 (58%) were 65 years and older, while 478 (16%) were 75 years and older. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.
Renal Impairment: No dosage adjustment is necessary in patients with mild or moderate renal impairment. There is limited experience with Bempedoic acid in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m 2 ), and Bempedoic acid has not been studied in patients with end-stage renal disease (ESRD) receiving dialysis.
Hepatic Impairment: No dosage adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh A or B. Patients with severe hepatic impairment (Child-Pugh C) have not been studied.
",,,,"Keep below 30oC temperature, protected from light & moisture. Keep out of the reach of children.
",9
+1787,Saccharomyces Boulardii,saccharomyces-boulardii-1787,,Herbal and Nutraceuticals,Ulcerative colitis,"Saccharomyces Boulardii is indicated for the prevention and treatment of following conditions:
+
+- Diarrhea associated with antibiotics
+- Traveler's diarrhea
+- Recurring intestinal disease caused by Clostridium difficile
+- Side effects of treatment for Helicobacter pylori
... Read more
Saccharomyces Boulardii is indicated for the prevention and treatment of following conditions:
+
+- Diarrhea associated with antibiotics
+- Traveler's diarrhea
+- Recurring intestinal disease caused by Clostridium difficile
+- Side effects of treatment for Helicobacter pylori
+- Symptoms of acute diarrhea
+- Diarrhea in infants
+- Crohn's disease
+- Ulcerative colitis and IBS
+
","Herbal and Nutraceuticals
","Saccharomyces boulardii strain survives stomach acid to colonize in the intestinal tract while acting as a temporary flora to protect the beneficial organisms of the intestine. Additionally, it works with the body to re establish the microflora, thereby helping to maintain and support healthy immunity, digestion and gut health. It shows the following actions:
Anti-toxin activity: S. boulardii produces proteins that work to neutralize bacterial toxins. This may include the toxins produced by Clostridium diffcile.
Anti-microbial: S. boulardii adheres to pathogens, which decreases their adhesion to the intestinal wall and decreases invasion of enterocytes into the body. These pathogens are then removed during bowel movements.
Enzymatic activity: In healthy adults, S. boulardii increases the enzymatic activities (lactase, alpha glucosidase, alkaline phosphatase). The production of intestinal polyamines by S. boulardii is one of its most relevant and specific mechanisms of action. The polyamines spermidine, spermine, and putrescine enhance the expression of brush border enzymes (such as hydrolases, proteases, and transport molecules).
Immune Enhancement: S. boulardii helps prevent infection by stimulating the immune system along the GI lining by increasing the protective antibody IgA.
Anti-inflammatory: S. boulardii causes a decrease in pro-inflammatory cytokines.
","Adult:
+
+- For diarrhea associated with the use of antibiotics: 250-500 mg of Saccharomyces boulardii two to four times a day.
+- For diarrhea caused by Clostridium difficile: 1 gram of Saccharomyces boulardii daily for 4 weeks along with antibiotic treatment.
+- For reduction in symptoms of acute diarrhea: 250 mg of Saccharomyces boulardii twice a day for 5 days.
+- For diarrhea in Crohn's disease: 250 mg of Saccharomyces boulardii three times daily has been used for up to 9 weeks.
+- For diarrhea in ulcerative colitis: 250 mg of Saccharomyces boulardii three times daily.
+- For treatment of infections due to Helicobacter pylori: 250 mg-500 mg Saccharomyces boulardii twice daily in addition to usual treatment.
+- For diarrhea in Irritable bowel syndrome (IBS): 250 mg capsule twice daily.
+- For traveler's diarrhea: The recommended dosage is 250 mg capsule per day.
+
+Children:
+
+- For reduction in symptoms of acute diarrhea: Children over three months are recommended to take two doses of 250 mg a day for five days. Children under three months are recommended to take 125 mg twice daily for five days.
+
",,"Taking Saccharomyces boulardii with medications for fungal infections (e.g. fluconazole, itraconazole, terbinafine and others) can reduce the effectiveness of it.
","It is contraindicated in patients with a history of hypersensitivity to Saccharomyces boulardii or any other components of this product.
","Saccharomyces boulardii is likely safe for most adults when taken by mouth. It can cause gas in some people.
","There is no available information about the safety of taking Saccharomyces boulardii in pregnancy and lactation.
",,,,,,"Store below 25° C, away from direct sunlight & moisture. Keep out of reach of children.
",9
+1753,Rohitakarista,rohitakarista-1753,,Herbal and Nutraceuticals,Jaundice,"This is indicated in Jaundice, Toxic liver injury, Hepatitis, Chronic indigestion, Anorexia.
","Herbal and Nutraceuticals
","Aphanamixis polystachya: It contains aphanamixin, amoorin, flindissol, melianone, rohitukin that have hepatoprotective, antiviral and antibacterial activities.
Woodfordia fructicosa: It has octacosanol, ß- sitosterol, polystachoside, ellagic acid and polyphenols, which are used in the treatment of liver diseases and bowel complaints.
Emblica officinalis: It is a rich source of vitamin C, which acts as an anti-oxidant. It also contains ellagic & phyllenbic acids, phyllantidine & phyllantine that are used in the treatment of jaundice, dyspepsia, and peptic ulcer. It decreases SGOT, SGPT and LDH. It reduces serum cholesterol, triglycerides, phospholipid & LDL levels. It also decreases glutathione depletion and prevents cytochrome P-450 stimulation.
Terminalia chebula: It contains anthraquinone glycoside, chebulinic acid, tannic acid, gallic acid that are used in enlarged spleen & liver. It promotes digestive power.
Terminalia belerica: It contains tannin, ß-sitosterol, gallic acid, ellagic acid. It has significant hepatoprotective activity and prevents the development of fatty liver. It increases the biliary secretion.
Zingiber officinale: It increases bile secretion & enhances gastrointestinal motility. It has anti-vomiting, anti flatulent and digestive activities.
Piper longum (Root & fruit): It facilitates the regeneration of hepatocytes following toxic liver damage. It has piperine alkaloid that stimulates digestive enzyme activity including that of pancreatic lipase, amylase, trypsin and chymotrypsin.
Elettaria cardamomum: It increases the flow of bile from gall bladder in to the intestine. It has also anti vomiting, anti-flatulent and digestive activities.
Cinnamomum tamala: It contains essential oil, eugenol, terpin and cinnamic aldehyde that has anti-flatulent & digestive activities.
Cinnamomum zeylanicum: It is a very efficient carminative & antispasmodic. It has also hepatoprotective and digestives activities.
","Adult: 2-4 tea-spoonful 2-3 times daily after meal.
Child: 1-2 tea-spoonful 2-3 times daily after meal.
",,,"There is no absolute contraindication.
","Not yet known.
",,,,,,,"Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.
",7
+1726,Rhubarb + Ginger,rhubarb-ginger-1726,,Herbal and Nutraceuticals,Nausea,"This is indicated in-
+
+- Heart burn
+- Abdominal pain due to gases
+- Nausea
+- Flatulence
+- Dyspepsia
+- Constipation
+
","Herbal and Nutraceuticals
","This is a unani medicine prepared with the valuable natural ingredients, which is highly effective in heart burn, flatulence, abdominal pain due to gases, dyspepsia and constipation. It discharges the excessive gas from stomach and bowels and improves the activity of digestive system.
","1 tablet twice daily or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in therapeutic dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool & dry place, away from direct sunlight.
",8
+1707,Rehmin,rehmin-1707,,Herbal and Nutraceuticals,Vaginal leucorrhoea,"Rehmin is indicated in-
+
+- Leucorrhoea
+- Weakness of uterus
+- Menstrual irregularity
+- Dysmenorrhoea
+- Uterine inflammation
+
","Herbal and Nutraceuticals
","This is a unique combination of Betel nut (Areca catechu), Bengle kino (Butea monosperma) and other natural ingredients; it acts as an astringent, anti-inflammatory and emmenagogue. This tablet tones up and restores the normal functions of uterus, prevents urinary discharge; particularly useful for watery discharge from vagina. It is also very effective in leucorrhoea and menstrual irregularity.
","1-2 tablet(s) twice daily before meal or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+100,Azithromycin Dihydrate,azithromycin-dihydrate-100,https://medex.com.bd/attachments/EpvUfi7nq1msZEf632MRAGhVIAqFtU/azithromycin-dihydrate-prescribing-information,,,"Azithromycin is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia, in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, in otitis media, and in skin and soft tissue infections. In sexually ... Read more
Azithromycin is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia, in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, in otitis media, and in skin and soft tissue infections. In sexually transmitted diseases in men and women, Azithromycin is indicated in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.
",,"Azithromycin is acid-stable and can therefore be taken orally with no need of protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. Time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.
Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.
Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:
+
+- Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
+- Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
+- Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
+- Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
+- Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
+- Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia
+
","Oral-
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.
Children:
+
+- 10 mg/kg body weight once daily for 3 days for child over 6 months
+- 200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
+- 300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
+- In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.
+
+
Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:
+
+- 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
+- The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
+- Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.
+
","Reconstitution procedure of suspension-
+
+- Step 01: Shake the bottle well to loosen the powder.
+- Step 02: Add boiled and cooled water up to the water mark of the bottle label.
+- Step 03: Shake until powder is completely mixed with water.
+
+Azithromycin should be taken at least 1 hour before or 2 hours after meal.
","Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids Azithromycin should be avoided because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P-450 system. As macrolides increase the plasma concentration of digoxin and cyclosporin, caution should be exercised while co-administration. There have been no drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone or Cimetidine.
","Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.
","Azithromycin is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhoea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.
","Pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.
","As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment.
",,"There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.
",,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",11
+1634,Azilsartan Medoxomil + Chlorthalidone,azilsartan-medoxomil-chlorthalidone-1634,https://medex.com.bd/attachments/Og8m3tXii7EoMOTK1TdxuOXDmKaH3M/azilsartan-medoxomil-chlorthalidone-prescribing-information,Combined antihypertensive preparations,Stroke,"For the treatment of hypertension, to lower blood pressure:
+
+- In patients not adequately controlled with ARB monotherapy
+- As initial therapy in patients likely to need multiple drugs to help
+
+To achieve blood pressure goals and to reduce the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
","Combined antihypertensive preparations
","Azilsartan medoxomil is an angiotensin II receptor blocker (ARB). Azilsartan helps blood vessels to dilate. It also helps to excrete of Sodium and water from body. This combination also contains a diuretic. Chlorthalidone works in the kidneys to flush excess water and salt (sodium) from the body. Together, these 2 medicines work to help lower blood pressure in people who need more than 1 medicine to treat their high blood pressure (hypertension).
","The recommended starting dose is 40/12.5 mg taken orally once daily. Most of the antihypertensive effect is apparent within 1 to 2 weeks. This combination may be used to provide additional blood pressure lowering for patients not adequately controlled on ARB or diuretic monotherapy treatment. Patients not controlled with azilsartan medoxomil 80 mg may have an additional systolic/diastolic clinic blood pressure reduction of 13/6 mm Hg when switched to this combination 40/12.5 mg.
This combination may be used as initial therapy if a patient is likely to need multiple drugs to achieve blood pressure goals. Patients titrated to the individual components (azilsartan medoxomil and chlorthalidone) may instead receive the corresponding dose of This combination.
",,"Renal clearance of lithium is reduced by diuretics, such as chlorthalidone increasing the risk of lithium toxicity. NSAIDs increase risk of renal dysfunction and interfere with antihypertensive effect
","This is contraindicated in patients with anuria.
","The following potential adverse reactions are-
+
+- Fetal toxicity
+- Hypotension in Volume- or Salt-Depleted Patients
+- Impaired Renal Function
+- Hypokalemia Hyperuricemia
+
","Pregnancy Category D. Use of drugs that affect the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
","
+- In patients with an activated renin-angiotensin-aldosterone system (RAAS), such as volume- and/or salt-depleted patients, this combination can cause excessive hypotension. Correct volume or salt depletion prior to administration of azilsartan and chlorthalidone.
+- In patients with renal artery stenosis, This combination may cause renal failure.
+- Monitor renal function in patients with renal impairment. Consider discontinuing this combination with progressive renal impairment.
+- Heart rhythm problems (e.g., bradycardia, QT prolongation, ventricular tachycardia), liver problems, certain uncorrected mineral imbalances (low potassium/magnesium levels), severe kidney problems.
+
",,,,,"Store in a cool & dry place, away from light and children.
",10
+145,Bromhexine Hydrochloride,bromhexine-hydrochloride-145,https://medex.com.bd/attachments/eaFceLQmL224hASL0GvbN8gOZGB6un/bromhexine-hydrochloride-prescribing-information,Cough expectorants & mucolytics,Bronchitis,"Bromhexine is indicated in the treatment of respiratory tract disorders associated with productive cough. This include-
+
+- Tracheobronchitis
+- Bronchitis with emphysema
+- Bronchiectasis
+- Bronchitis with bronchospasm
+- Chronic inflammatory pulmonary conditions and
+- Pneumoconiosis.
+
","Cough expectorants & mucolytics
","Bromhexine Hydrochloride is an oral mucolytic agent. It disrupts the structure of acid mucopolysaccharide fibres in mucoid sputum and produces less viscous mucus, which makes easier the expectoration. It is rapidly & completely absorbed from the gastrointestinal tract. It is widely distributed into the body tissues.
","The recommended doses for adults and children are stated below:
+
+- Adult & Children over 12 years: 10 ml (2 teaspoons) 3 times daily
+- Children 6-12 years: 5 ml (1 teaspoon) 3 times daily
+- Children 2-6 years: 2.5 ml (1/2 teaspoon) 3 times daily
+- Bromhexine Hydrochloride is not recommended for children under 2 years of age without advice.
+
",,"There are no known significant interactions with other drugs.
","It is contraindicated in known hypersensitivity to Bromhexine Hydrochloride or any of the ingredients of this product.
","Gastrointestinal side effects may occur occasionally. A transient rise in serum aminotransferase values has been reported. Other reported side effects include-headache, vertigo (dizziness) and allergic reactions.
","Use in Pregnancy: Special care is recommended during pregnancy. The benefits of bromhexine must be assessed against possible effects on children.
Use in Lactation: Bromhexine is expected to enter breast milk. Therefore it is not recommended that bromhexine be taken by lactating mothers.
","Since mucolytics may disrupt the gastric mucosa bromhexine should be used with care in patients with a history of peptic ulcer disease. Care is also advisable in asthmatic patients. Clearance of bromhexine and its metabolites may be reduced in patients with severe hepatic or renal impairment.
",,,,,"Keep in a dry place away from light and heat. Keep out of reach of children.
",10
+144,Bromfenac Sodium,bromfenac-sodium-144,https://medex.com.bd/attachments/s20ndy6HkXwFgA2KhUJ7ZYEJmYNTM9/bromfenac-sodium-009-ophthalmic-solution-prescribing-information,Ophthalmic Non-Steroid drugs,Postoperative ocular inflammation,"Bromfenac is indicated for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract extraction
","Ophthalmic Non-Steroid drugs
","Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID). The mechanism of anti-inflammatory activity is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2. Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis and increased intraocular pressure.
","Adults: 1 drop to the problem eye 2 times a day; treatment should start 24 hours after surgery and should continue for 2 weeks
Children: Use and dose must be determined by the doctor.
Pediatric Use: Safety and efficacy in pediatric patients below the age of 18 have not been established yet.
",,,"Bromfenac ophthalmic solution is contraindicated in patients with known hypersensitivity to any ingredients of the formulation.
","The most commonly reported adverse reactions following use of Bromfenac after cataract surgery include: abnormal sensation in eye, conjunctival hyperemia, eye irritation (including burning/stinging), eye pain, eye pruritus, eye redness, headache and iritis. These events were reported in 2-7% of patients
","Pregnancy Category C. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Bromfenac ophthalmic solution is administered to a nursing mother.
","All topical NSAIDs may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. It is recommended that Bromfenac ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. Bromfenac ophthalmic solution should not be administered while wearing contact lenses.
Bromfenac ophthalmic solution contains Sodium Sulfite, a compound that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
",,,,,"Keep out of the reach of children. Store in a cool, dry place, away from heat and direct light. Do not use more than 4 weeks after opening.
",9
+148,Bromelain + Trypsin,bromelain-trypsin-148,,Enzymes,Sprains,"Bromelain & Trypsin is indicated for inflammatory pains, soft tissue inflammation, edema associated with trauma and surgery such as in gynaecological conditions, breast engorgement, fractures, sprains, injuries, hemorrhoid, anal prolapse
","Enzymes
","Trypsin is an enzyme. An enzyme is a protein that speeds up a certain biochemical reaction. Trypsin is found in the small intestine. It can also be made from fungus, plants, and bacteria. But it is usually made for commercial purposes from the pancreas of livestock. Trypsin is given to people who lack enzymes needed for digestion. It is also given in combination with bromelain and rutin for treatment of osteoarthritis.
Bromelain is a protein extract derived from the stems of pineapples, although it exists in all parts of the fresh plant and fruit. The extract has a history of folk medicine use. As a culinary ingredient, it may be used as a meat tenderizer. The term ""bromelain"" may refer to either of two protease enzymes extracted from the plants of the family Bromeliaceae, or it may refer to a combination of those enzymes along with other compounds produced in an extract.
","Initially 2 tabs 3 times daily. Maintenance 1 tab 3 times daily preferably before meals
",,"There are no known drug interactions and none well documented.
","Hypersensitivity.
","Trypsin seems to be safe when used by healthcare professionals for wound cleaning and healing. It can cause side effects such as pain and burning. Not enough is known about the safety of trypsin for its other uses.
","Pregnancy Category-Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
","Allergies: If you are allergic to pineapple, latex, wheat, celery, papain, carrot, fennel, cypress pollen, or grass pollen, you might have an allergic reaction to bromelain.
Surgery: Bromelain might increase the risk of bleeding during and after surgery. Stop using bromelain at least 2 weeks before a scheduled surgery.
",,,,,,9
+143,Bromazepam,bromazepam-143,https://medex.com.bd/attachments/bucccbFWV4MKoKqyr3H6haMIPuXHOH/bromazepam-prescribing-information,Benzodiazepine sedatives,Panic attack,"Bromazepam is indicated in-
+
+- Emotional disturbances, i.e. acute tension and anxiety states. Difficulties in interpersonal contact. Agitation, insomnia, anxious and agitated depressive reactions.
+- Functional disturbances in the cardiovascular and respiratory systems, i.e. pseudoangina pectoris, pericardial anxiety, tachycardia, emotiogenic hypertension, dyspnea and hyperventilation.
... Read more
Bromazepam is indicated in-
+
+- Emotional disturbances, i.e. acute tension and anxiety states. Difficulties in interpersonal contact. Agitation, insomnia, anxious and agitated depressive reactions.
+- Functional disturbances in the cardiovascular and respiratory systems, i.e. pseudoangina pectoris, pericardial anxiety, tachycardia, emotiogenic hypertension, dyspnea and hyperventilation.
+- Disturbances in the gastrointestinal tract, i.e. irritable bowel syndrome, epigastric pain, spasm, bloating diarrhea etc.
+- Disturbances in the urinary tract, i.e. frequency, irritable bladder and dysmenorrhea.
+- Psychosomatic disorder, i.e. psychogenic headache, asthma, gastric and duodenal ulcer.
+- It is also indicated in emotional reactions to chronic organic disease.
+
","Benzodiazepine sedatives
","Bromazepam is a powerful psychotropic agent. In lower dosage, it selectively reduces tension and anxiety. In higher dosage, it shows sedative and muscle-relaxant properties. Bromazepam binds to the GABA-A receptor producing a conformational change and potentiating its inhibitory effects. Other neurotransmitters are not influenced.
","Standard dosage: Average dosage for outpatient therapy is 1.5-3 mg up to three times daily. Treatment of outpatients should begin with low doses, gradually increasing to the optimum level.
In severe cases, especially in hospital: 6-12 mg 2 or 3 times daily. The overall treatment generally should not be more than 8-12 weeks. In certain cases extension beyond the maximum treatment period may be necessary; if so, it should be taken with re-evaluation of the patient's status with special expertise.
Elderly and debilitated patients: Elderly patients and those with impaired hepatic functions require lower doses.
Children: Bromazepam is usually not indicated in children, but if the physician feels bromazepam treatment is appropriate, then the dose should be adjusted to their low bodyweight (about 0.1-0.3 mg/kg bodyweight)
","Bromazepam tablets are for oral administration
","If bromazepam is combined with other centrally active drugs, its sedative effects may be enhanced. These drugs are antidepressants, hypnotics, narcotics, antipsychotics, sedatives, antiepileptic drugs, sedative antihistamines and anesthetics. Co-administration of cimetidine may prolong the eliminiation half-life of bromazepam. Concomitant intake of bromazepam with alcohol should be avoided, because the sedative effect of bromazepam may be intensified by alcohol.
","Bromazepam is contraindicated in patients with known hypersensitivity to bromazepam, severe respiratory insufficiency, severe hepatic insufficiency or sleep apnea syndrome.
","Common side-effects include fatigue, drowsiness, muscle weakness, numbed muscle, reduced alertness, confusion, headache, ataxia etc. These phenomena occur predominantly at the start of therapy and usually disappear with prolonged administration. Anterograde amnesia may occur using therapeutic doses.
","The safety of bromazepam during pregnancy has not been established. As bromazepam is excreted in breast milk, use should be avoided during lactation.
","The use of benzodiazepines and benzodiazepine like agents may lead to the development of physical and psychological dependence upon these products. This dependence depends on the dose and duration of treatment; it is also greater in predisposed patients with a history of alcohol. Once physical dependence has developed, termination of the treatment will be accompanied by withdrawal symptoms. These may consist of headache, muscle pain, extreme anxiety, tension, confusion and irritability. Since the risk of withdrawal phenomena and rebound phenomena is greater after abrupt discontinuation of the treatment, it is recommended that the dosage be decreased gradually. Bromazepam is not recommended for the primary treatment of sleeplessness caused by psychotic illness. Caution should be exercised while driving cars or using machineries.
",,,,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",11
+1566,Brivaracetam,brivaracetam-1566,https://medex.com.bd/attachments/GoUVGbracrEICiMQN5JS07RaAeH6yd/brivaracetam-prescribing-information,Adjunct anti-epileptic drugs,Partial seizures,"Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. As the safety of Brivaracetam injection in pediatric patients has not been established, Brivaracetam injection is indicated for the treatment of partial-onset seizures only in adult patients (16 years of age and older).
","Adjunct anti-epileptic drugs
","The precise mechanism by which Brivaracetam exerts its anticonvulsant activity is not known. Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect.
Brivaracetam binds SV2A with high affinity. SV2A is known to play a role in epileptogenesis through modulation of synaptic GABA release. It is thought that brivaracetam exerts its anti-epileptogenic effects through its binding to SV2A. Brivaracetam is also known to inhibit Na+ channels which may also contribute to its anti-epileptogenic action
","Adults (16 Years and older): The recommended starting dosage for monotherapy or adjunctive therapy is 50 mg twice daily (100 mg per day).
Based on individual patient tolerability and therapeutic response, the dosage may be adjusted down to 25 mg twice daily (50 mg per day) or up to 100 mg twice daily (200 mg per day).
Pediatric Patients (4 Years to less than 16 Years): The recommended dosage is based on body weight and is administered orally twice daily
Injection: for intravenous and adult use only when oral administration is temporarily not feasible; dosing is the same as oral regimen.
","Brivaracetam injection should be administered intravenously over 2 to 15 minutes. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Product with particulate matter or discoloration should not be used. Brivaracetam injection is for single dose only.
","Rifampin: Because of decreased concentrations, increasing Brivaracetam dosage in patients on concomitant rifampin is recommended.
Carbamazepine: Because of increased exposure to carbamazepine metabolite, if tolerability issues arise, consider reducing carbamazepine dosage in patients on concomitant Brivaracetam.
Phenytoin: Because phenytoin concentrations can increase, phenytoin levels should be monitored in patients on concomitant Brivaracetam.
Levetiracetam: Brivaracetam had no added therapeutic benefit when co-administered with levetiracetam.
","Hypersensitivity to brivaracetam or any of the inactive ingredients in Brivaracetam
","Most common adverse reactions (at least 5% for Brivaracetam and at least 2% more frequently than placebo) are somnolence/sedation, dizziness, fatigue, and nausea or vomiting.
","There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as Brivaracetam, during pregnancy. No data are available regarding the presence of brivaracetam in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Studies in lactating rats have shown excretion of brivaracetam or metabolites in milk
","Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and ideation.
Neurological Adverse Reactions: Monitor for somnolence and fatigue, and advise patients not to drive or operate machinery until they have gained sufficient experience on Brivaracetam.
Psychiatric Adverse Reactions: Behavioral reactions including psychotic symptoms, irritability, depression, aggressive behavior, and anxiety; monitor patients for symptoms.
Hypersensitivity: Bronchospasm and Angioedema: Advise patients to seek immediate medical care. Discontinue and do not restart Brivaracetam if hypersensitivity occurs.
Withdrawal of Antiepileptic Drugs: Brivaracetam should be gradually withdrawn.
","Hepatic Impairment: Dose adjustment is recommended for all stages of hepatic impairment.
Renal Impairment: Dose adjustments are not required for patients with impaired renal function.
",,,,"Store at 25°C; excursions permitted between 15°C to 30°C
",12
+141,Brinzolamide + Brimonidine Tartrate,brinzolamide-brimonidine-tartrate-141,https://medex.com.bd/attachments/SH8VufKfpaFuuWnCa0WCCg7oK7foxY/brinzolamide-brimonidine-tartrate-prescribing-information,Drugs for miotics and glaucoma,Open angle glaucoma,"This is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
","Drugs for miotics and glaucoma
","Brinzolamide is a carbonic anhydrase inhibitor which reduce intraocular pressure (IOP) by decreasing aqueous humor secretion in the ciliary processes of the eye.
Brimonidine Tartrate is an alpha 2 adrenergic receptor agonist which reduces IOP by decreasing aqueous humor production and increasing uveoscleral outflow.
","Instill one drop in the affected eye(s) three times daily. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. Shake well before use.
",,"In patients treated with this drop rare instances to drug interactions have occurred with high-dose salicylate therapy, CNS Depressants, Antihypertensives/ Cardiac Glycosides, Tricyclic Antidepressants, Monoamine Oxidase Inhibitors. Therefore, the potential for such drug interactions should be considered in patients receiving Brinzolamide + Brimonidine Tartrate .
","It is contraindicated in patients who are hypersensitivity to Brinzolamide, Brimonidine Tartrate, or to any ingredient in the formulation and Neonates and Infants (under the age of 2 years).
","The most commonly reported side effects include blurred vision, eye irritation, bad taste and dry mouth.
","Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Brinzolamide and Brimonidine Tartrate ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether Brinzolamide or Brimonidine Tartrate are excreted in human milk. Caution should be exercised while giving this ophthalmic suspension to a nursing mother.
","Shake well before use. For ophthalmic use only. Contact lenses should be removed during instillation of Brinzolamide and Brimonidine Tartrate ophthalmic suspension, but may be reinserted 15 minutes after instillation.
","Use in children: Safety & effectiveness in children below the age of 2 years have not been established.
Use in elderly patients: No overall differences in safety and effectiveness have been observed between elderly and other adult patients.
","Although no human data are available, electrolyte imbalance, development of an acidotic state, and possible nervous system effects may occur following an oral overdose of Brinzolamide. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored. Very limited information exists on accidental ingestion of Brimonidine Tartrate in adults; the only adverse event reported to date has been hypotension. Symptoms of Brimonidine Tartrate overdose have been reported in neonates, infants, and children receiving Brimonidine Tartrate as part of medical treatment of congenital glaucoma or by accidental oral ingestion. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.
",,,"Store at room temperature & protect from light. Do not touch dropper tip to any surface. It is desirable that the contents should not be used more than one month after first opening of the bottle. Shake well before use & do not freeze.
",12
+1282,Brinzolamide + Timolol,brinzolamide-timolol-1282,https://medex.com.bd/attachments/2jVVtgks0mXT4ef5X4hQhvki5HQZD0/brinzolamide-timolol-prescribing-information,Drugs for miotics and glaucoma,Open angle glaucoma,"Treatment of elevated IOP in adult patients with open-angle glaucoma or ocular HTN for whom monotherapy provides insufficient IOP reduction.
","Drugs for miotics and glaucoma
","Brinzolamide is a highly specific inhibitor of CA-II, which is the main CA isoenzyme involved in the secretion of aqueous humor. Inhibition of CA in the ciliary process of the eye slows the formation of bicarbonate, and reduces sodium and fluid transport. This results in a reduction in the rate of aqueous humor secretion and the intraocular pressure. Brinzolamide is absorbed systemically following topical ocular administration. Since it has a high affinity for CA-II, brinzolamide binds extensively to red blood cells, where CA-II is primarily found. As sufficient CA-II activity remains, adverse effects resulting from the systemic inhibition of CA by brinzolamide are not observed. The metabolite N-desethyl brinzolamide is also formed. This metabolite binds to CA and accumulates in red blood cells as well. In the presence of brinzolamide, the metabolite binds mainly to carbonic anhydrase I (CA-I).
Like propranolol and nadolol, timolol competes with adrenergic neurotransmitters such as catecholamines for binding at beta(1)-adrenergic receptors in the heart and vascular smooth muscle and beta(2)-receptors in the bronchial and vascular smooth muscle. Beta(1)-receptor blockade results in a decrease in resting and exercise heart rate and cardiac output, a decrease in both systolic and diastolic blood pressure, and, possibly, a reduction in reflex orthostatic hypotension. Beta(2)-blockade results in an increase in peripheral vascular resistance. The exact mechanism whereby timolol reduces ocular pressure is still not known. The most likely action is by decreasing the secretion of aqueous humor.
","1 drop into the affected eye(s) twice daily
",,"Ketoconazole, itraconazole, clotrimazole, ritonavir, troleandromycin; oral Ca-channel blockers, guanethidine, β-blockers, antiarrhythmics, digitalis glycosides, parasympathomimetics; quinidine, cimetidine.
","Bronchial asthma, severe COPD, sinus bradycardia, 2nd or 3rd degree AV block, overt cardiac failure, cardiogenic shock, severe allergic rhinitis, bronchial hyperreactivity, hyperchloraemic acidosis, severe renal impairment.
","Dysgeusia, blurred vision, eye pain & irritation, foreign body sensation.
","No data available
","Control cardiac failure prior to therapy. History of severe cardiac & resp disease. Patients subject to hypoglycemia or labile insulin-dependent diabetes. May mask hyperthyroidism or worsen Prinzmetal's angina, severe peripheral & central circulatory disorders & hypotension. History of atopy or severe anaphylactic reaction to a variety of allergens. Avoid concomitant use of 2 local β-adrenergic blockers or 2 local carbonic anhydrase inhibitors. Close monitoring of IOP in patients with pseudoexfoliative or pigmentary glaucoma. Narrow-angle glaucoma. Monitor patients with compromised corneas eg, patients with DM or corneal dystrophies. Remove contact lenses prior to application; reinsert after 15 min. May impair ability to drive or operate machinery. Pregnancy. Childn <18 yr.
",,,,,"Store in cool and dry place
",10
+142,Brinzolamide,brinzolamide-142,https://medex.com.bd/attachments/ugTnqdKNfRKapm7tfq55SkhBz0kryQ/brinzolamide-prescribing-information,Drugs for miotics and glaucoma,Open angle glaucoma,"Brinzolamide Ophthalmic Suspension is indicated as monotherapy, or as adjunctive therapy to beta-blockers in the treatment of elevated intraocular pressure in ocular hypertension, or open-angle glaucoma.
","Drugs for miotics and glaucoma
","Carbonic anhydrase (CA) is an enzyme found in many tissues of the body including the eye. It catalyses the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid. It exists as a number of isoenzymes, the most active being carbonic anhydrase II (CA-II), found primarily in red blood cells, but also in other tissues. Inhibition of carbonic anhydrase in the ciliary processes of the eye decreases aqueous humor secretion, presumably by slowing the formation of bicarbonate ions with subsequent reduction in sodium and fuid transport.
Following topical ocular administration, brinzolamide inhibits aqueous humor formation and reduces elevated intraocular pressure. Elevated intraocular pressure is a major risk factor in the pathogenesis of optic nerve damage and glaucomatous visual feld loss.
","The recommended dose is one drops of this eye drop in the conjunctival sac of the affected eye(s) twice daily. Some patients may have a better response with one drop three times a day. Shake well before use.
",,"In patients treated with oral carbonic anhydrase inhibitors, rare instances to drug interactions have occurred with high-dose salicylate therapy. Therefore, the potential for such drug interactions should be considered in patients receiving Brinzolamide.
","It is contraindicated in patients who are hypersensitive to any component of this product.
","Reported side effects are blurred vision and bitter, sour or unusual taste. Other side effects are blepharitis, dermatitis, dry eye, foreign body sensation, headache, hyperemia, ocular discharge, ocular discomfort, ocular keratitis, ocular pain, ocular pruritus and rhinitis.
","Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Brinzolamide 1% ophthalmic suspension should be used during pregnancy only if the benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether Brinzolamide 1% ophthalmic suspension is excreted in human milk. So, lactating mother should discontinue nursing or to discontinue the drug, depending upon the importance of the drug to the mother.
","
+- Brinzolamide ophthalmic suspension and its metabolite are excreted predominantly by the kidney. So, it is not recommended in severe renal impaired patients.
+- Brinzolamide ophthalmic suspension has not been studied in patients with hepatic impairment and should be used with caution in such patients.
+- The concomitant administration of Brinzolamide ophthalmic suspension and oral carbonic anhydrase inhibitor is not recommended due to no additional benefits.
+- If hypersensitivity reaction occurs after instillation patients should be advised to discontinue the use of Brinzolamide and consult with physicians.
+
",,"Although no human data are available, electrolyte imbalance, development of an acidosis state, and possible nervous system effects may occur following oral administration of an overdose. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.
",,,"Store at room temperature & protect from light. Do not touch dropper tip to any surface. It is desirable that the contents should not be used more than four weeks after first opening of the bottle. Protect from freezing.
",11
+140,Brimonidine Tartrate + Timolol Maleate,brimonidine-tartrate-timolol-maleate-140,https://medex.com.bd/attachments/bxt7LJCjlFxCUeXcq33EJ5G0yF0GSa/brimonidine-tartrate-timolol-maleate-prescribing-information,Drugs for miotics and glaucoma,Open angle glaucoma,"This eye drop is indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.
","Drugs for miotics and glaucoma
","This eye drops is comprised of two components: Brimonidine Tartrate & Timolol Maleate. Brimonidine Tartrate is a selective alpha-2 adrenergic receptor agonist having a dual mechanism of action. It decreases aqueous humor production and increases nonpressure dependent uveoscleral outflow. Timolol Maleate is a β-adrenergic receptor antagonist that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic (membrane-stabilizing) activity. It lowers IOP by reducing aqueous humor production. Therefore the combination of both drugs gives a rapid onset of action, with peak ocular hypotensive effect seen within two hours of administration.
","Instill 1 drop in the affected eye(s) twice daily.
",,"Specific drug interaction studies have not been conducted.
","Contraindicated in patients with hypersensitivity to any component of this product. Also contraindicated in bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third-degree atrioventricular block, overt cardiac failure and cardiogenic shock.
","The most common side effects are allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperaemia, eye pruritus and ocular burning or stinging.
","There are no adequate and well-controlled studies in pregnant women. Combipres should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Timolol has been detected in human milk but it is not known whether Brimonidine Tartrate is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue taking into account the importance of the drug to the mother.
","Like other topically applied ophthalmic agents, it may be absorbed systemically. Due to the presence of Timolol, the same types of cardiovascular and pulmonary adverse reactions as seen with systemic beta-blockers may occur. Cautions should be exercised in treating patients with severe or unstable and uncontrolled cardiovascular or pulmonary diseases.
","Use in children: Safety and effectiveness in children below the age of 2 years have not been established.
Use in elderly patients: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
",,,,"Store at a cool & dry place, protect from light. Do not use longer than 30 days after the first opening of the bottle. Keep out of the reach of children.
",11
+139,Brimonidine Tartrate,brimonidine-tartrate-139,https://medex.com.bd/attachments/8DmtdnrbuUdRP16AzB95iJg5kNiTDr/brimonidine-tartrate-02-prescribing-information,Drugs for miotics and glaucoma,,"Brimonidine Tartrate 0.2% ophthalmic solution is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Brimonidine Tartrate 0.15% ophthalmic solution is indicated for the control of intraocular pressure in patients with chronic open-angle ... Read more
Brimonidine Tartrate 0.2% ophthalmic solution is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Brimonidine Tartrate 0.15% ophthalmic solution is indicated for the control of intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension.
Brimonidine Tartrate 0.025% ophthalmic solution relieves redness of the eye due to minor eye irritations.
","Drugs for miotics and glaucoma
","Brimonidine is an α-2 adrenoreceptor agonist that is more selective for the α-2 adrenoreceptor than α-1. Topical administration of Brimonidine Tartrate eye drops decreases intraocular pressure (IOP) in humans. When used as directed Brimonidine Tartrate have the action of reducing elevated IOP with minimal effect on cardiovascular parametres. Brimonidine Tartrate eye drops have a rapid onset of action with the peak ocular hypotensive effect occurring at two hours post-dosing. The duration of effect is 12 hours or greater. Fluorophotometric studies in animals and humans suggest that Brimonidine Tartrate has a dual mechanism of action. Brimonidine Tartrate eye drops lower IOP by reducing aqueous humor production and enhancing uveoscleral outflow.
","0.2% ophthalmic solution: The recommended dose is one drop of 0.2% ophthalmic solution in the affected eye(s) three times daily, approximately 8 hours apart. This ophthalmic solution may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart.
0.15% ophthalmic solution: The recommended dose is one drop of 0.15% ophthalmic solution in the affected eye(s) three times daily, approximately 8 hours apart.
0.025% ophthalmic solution: Instill 1 drop in the affected eye(s) every 6-8 hours. Do not use it more than 4 times daily. If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart.
",,"Although specific drug interaction studies have not been conducted with Brimonidine Tartrate ophthalmic solution, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics) should be considered. Alpha-agonists, as a class, may reduce pulse and blood pressure. Caution in using concomitant drugs such as beta-blockers (ophthalmic and systemic), antihypertensives and/or cardiac glycosides is advised. Tricyclic antidepressants have been reported to blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of these agents with Brimonidine Tartrate ophthalmic solution in humans can lead to resulting interference with the IOP lowering effect. No data on the level of circulating catecholamines after administration of Brimonidine Tartrate ophthalmic solution are available. Caution, however, is advised in patients taking Tricyclic antidepressants which can affect the metabolism and uptake of circulating amines.
","Brimonidine Tartrate ophthalmic solution is contraindicated in patients with hypersensitivity to Brimonidine Tartrate. It is also contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy.
","Adverse events occurring in approximately 10-30% of the subjects, in descending order of incidence, included oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions, and ocular pruritus. Events occurring in approximately 3-9% of the subjects, in descending order included corneal staining/erosion, photophobia, eyelid erythema, ocular ache/pain, ocular dryness, tearing, upper respiratory symptoms, eyelid edema, conjunctival edema, dizziness, blepharitis, ocular irritation, gastrointestinal symptoms, asthenia, conjunctival blanching, abnormal vision and muscular pain. The following adverse reactions were reported in less than 3% of the patients: lid crusting, conjunctival hemorrhage, abnormal taste, insomnia, conjunctival discharge, depression, hypertension, anxiety, palpitations/arrhythmias, nasal dryness and syncope.
","There are no adequate and well-controlled studies in pregnant women. In animal studies, Brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. Brimonidine Tartrate ophthalmic solution 0.2% should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk; in animal studies Brimonidine Tartrate was excreted in breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","Although Brimonidine Tartrate ophthalmic solution had minimal effect on the blood pressure of patients in clinical studies, caution should be exercised in treating patients with severe cardiovascular disease. Brimonidine Tartrate ophthalmic solution should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans.
",,,,,"Store below 30°C in a cool and dry place protected from light. Keep out of reach of children. Do not touch the dropper tip to surfaces since this may contaminate the solution. Do not use after 30 days of first opening.
",10
+1641,Brigatinib,brigatinib-1641,https://medex.com.bd/attachments/b5W0dBfIK9VddN15QX0JfdLEQFGy3t/brigatinib-prescribing-information,Cytotoxic Chemotherapy,Metastatic non-small cell lung cancer,"Brigatinib is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic Non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to Crizotinib.
","Cytotoxic Chemotherapy
","Brigatinib is a tyrosine kinase inhibitor with in vitro activity at clinically achievable concentrations against multiple kinases including ALK, ROS1, insulin-like growth factor-1 receptor (IGF-1R), and FLT-3 as well as EGFR deletion and point mutations. Brigatinib inhibited autophosphorylation of ALK and ALK-mediated phosphorylation of the downstream signaling proteins STAT3, AKT, ERK1/2, and S6 in in-vitro and in vivo assays. Brigatinib also inhibited the in vitro proliferation of cell lines expressing EML4-ALK and NPM ALK fusion proteins and demonstrated dose-dependent inhibition of EML4-ALK-positive NSCLC xenograft growth in mice. Brigatinib exposure-response relationships and the time course of the pharmacodynamic response are unknown.
Absorption: Following administration of single oral doses of Brigatinib of 30 to 240 mg, the median time to peak concentration (Tmax) ranged from 1 to 4 hours.
Distribution: Brigatinib is 66% bound to human plasma proteins and the binding is not concentration-dependent in vitro. The blood to plasma concentration ratio is 0.69. Following oral administration of Brigatinib 180 mg once daily, the mean apparent volume of distribution (Vz/F) of Brigatinib at steady-state was 153 L.
Elimination: Following oral administration of Brigatinib 180 mg once daily, the mean apparent oral clearance (CL/F) of Brigatinib at steady-state is 12.7 L/h and the mean plasma elimination half-life is 25 hours.
Metabolism: Brigatinib is primarily metabolized by CYP2C8 and CYP3A4 in vitro. Following oral administration of a single 180 mg dose of radiolabeled Brigatinib to healthy subjects, N-demethylation and cysteine conjugation were the two major metabolic pathways. Unchanged Brigatinib (92%) and its primary metabolite, AP26123 (3.5%), were the major circulating radioactive components. The steady-state AUC of AP26123 was less than 10% of AUC of Brigatinib exposure in patients. The metabolite, AP26123, inhibited ALK with approximately 3-fold lower potency than Brigatinib in vitro.
Excretion: Following oral administration of a single 180 mg dose of radiolabeled Brigatinib to healthy subjects, 65% of the administered dose was recovered in feces and 25% of the administered dose was recovered in urine. Unchanged Brigatinib represented 41% and 86% of the total radioactivity in feces and urine, respectively.
","The recommended dosing regimen for Brigatinib is:
+
+- 90 mg orally once daily for the first 7 days;
+- If 90 mg is tolerated during the first 7 days, the dose should be increased to 180 mg orally once daily.
+
+Brigatinib should be administered until disease progression or unacceptable toxicity. If Brigatinib is interrupted for 14 days or longer for reasons other than adverse reactions, treatment should be resumed at 90 mg once daily for 7 days before increasing to the previously tolerated dose. Brigatinib may be taken with or without food. Patients should be instructed to swallow tablets whole. Tablets should not be crushed or chewed. If a dose of Brigatinib is missed or vomiting occurs after taking a dose, an additional dose should not be administered and take the next dose of Brigatinib should be taken at the scheduled time.
Pediatric Use: The safety and efficacy of Brigatinib in pediatric patients have not been established.
",,"Drugs that may Increase Brigatinib Plasma Concentrations: Strong CYP3A Inhibitors: Coadministration of Itraconazole, a strong CYP3A inhibitor, increased Brigatinib plasma concentrations and may result in increased adverse reactions. Concomitant use of strong CYP3A inhibitors with Brigatinib, including but not limited to certain Antivirals (e.g., Boceprevir, Cobicistat, Indinavir, Lopinavir, Nelfinavir, Ritonavir, Saquinavir), Macrolide antibiotics (e.g., Clarithromycin), Antifungals (e.g., Itraconazole, Ketoconazole, Posaconazole, Voriconazole), and Conivaptan should be avoided. Grapefruit or grapefruit juice should be avoided as it may also increase plasma concentrations of Brigatinib. If concomitant use of a strong CYP3A inhibitor cannot be avoided, the dose of Brigatinib should be reduced by approximately 50%.
Drugs that may Decrease Brigatinib Plasma Concentrations: Strong CYP3A Inducers: Coadministration of Brigatinib with Rifampin, a strong CYP3A inducer, decreased Brigatinib plasma concentrations and may result in decreased efficacy. Concomitant use of strong CYP3A inducers with Brigatinib should be avoided, including but not limited to Rifampin, Carbamazepine, Phenytoin, and St. John's Wort.
Drugs that may have their Plasma Concentrations altered by Brigatinib: CYP3A Substrates: Brigatinib induces CYP3A in vitro and may decrease concentrations of CYP3A substrates. Coadministration of ALUNBRIG with CYP3A substrates, including hormonal contraceptives, can result in decreased concentrations and loss of efficacy of CYP3A substrates.
","It is contraindicated in patients with known hypersensitivity to Brigatinib or any other components of this product.
","
+- Interstitial Lung Disease (ILD)/Pneumonitis
+- Hypertension
+- Bradycardia
+- Visual Disturbance
+- Creatine Phosphokinase (CPK) Elevation
+- Pancreatic Enzyme Elevation
+- Hyperglycemia
+
","Pregnancy: There are no clinical data on the use of Brigatinib in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient of the potential risk to a fetus.
Lactation: There are no data regarding the secretion of Brigatinib in human milk or its effects on the breastfed infant or milk production. Because of the potential for adverse reactions in breastfed infants, lactating women should be advised not to breastfeed during treatment with Brigatinib and for 1 week following the final dose.
Females Reproductive Potential: Females of reproductive potential should be advised to use effective non-hormonal contraception during treatment with Brigatinib and for at least 4 months after the final dose. Patients should be counseled to use a non-hormonal method of contraception since Brigatinib can render some hormonal contraceptives ineffective.
Males Reproductive Potential: Because of the potential for genotoxicity, males with female partners of reproductive potential should be advised to use effective contraception during treatment with Brigatinib and for at least 3 months after the final dose.
Infertility: Based on findings in male reproductive organs in animals, Brigatinib may cause reduced fertility in males.
","Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, and fatal pulmonary adverse reactions consistent with interstitial lung disease (ILD)/pneumonitis have occurred with Brigatinib. It should be withheld in any patient with new or worsening respiratory symptoms, and promptly evaluate for ILD/pneumonitis or other causes of respiratory symptoms (e.g., pulmonary embolism, tumor progression, and infectious pneumonia). Brigatinib should be discontinued permanently for Grade 3 or 4 ILD/pneumonitis or recurrence of Grade 1 or 2 ILD/pneumonitis.
Hypertension: Hypertension was reported in 11% of patients in the 90 mg group who received Brigatinib and 21% of patients in the 90-180 mg group. Grade 3 hypertension occurred in 5.9% of patients overall. Blood pressure should be controlled prior to treatment with Brigatinib. Blood pressure should be monitored after 2 weeks and at least monthly thereafter during treatment with Brigatinib. It should be withheld for Grade 3 hypertension despite optimal antihypertensive therapy. Permanent discontinuation of treatment should be considered with Brigatinib for Grade 4 hypertension or recurrence of Grade 3 hypertension. Caution should be used when administering Brigatinib in combination with antihypertensive agents that cause bradycardia.
Bradycardia: Bradycardia can occur with Brigatinib. Heart rate and blood pressure should be monitored during treatment with Brigatinib. Patients should be monitored more frequently if concomitant use of drug known to cause bradycardia cannot be avoided.
Visual Disturbance: Adverse reactions leading to visual disturbance including blurred vision, diplopia, and reduced visual acuity, were reported in 7.3% of patients receiving Brigatinib in the 90 mg group and 10% of patients in the 90-180 mg group. Patients should be advised to report any visual symptoms. Brigatinib should be withheld and obtained an ophthalmologic evaluation in patients with new or worsening visual symptoms of Grade 2 or greater severity. Upon recovery of Grade 2 or Grade 3 visual disturbances to Grade 1 severity or baseline, Brigatinib should be resumed at a reduced dose. Treatment with Brigatinib should be permanently discontinued for Grade 4 visual disturbances.
Creatine Phosphokinase (CPK) Elevation: Creatine phosphokinase (CPK) elevation occurred in 27% of patients receiving Brigatinib in the 90 mg group and 48% of patients in the 90 mg-180 mg group. Patients should be advised to report any unexplained muscle pain, tenderness, or weakness. CPK levels should be monitored during Brigatinib treatment. Brigatinib should be withheld for Grade 3 or 4 CPK elevation.
Pancreatic Enzyme Elevation: Amylase elevation occurred in 27% of patients in the 90 mg group and 39% of patients in the 90→180 mg group. Lipase elevations occurred in 21% of patients in the 90 mg group and 45% of patients in the 90→180 mg group. Lipase and amylase should be monitored during treatment with Brigatinib. Brigatinib should be withheld for Grade 3 or 4 pancreatic enzyme elevation.
Hyperglycemia: 43% of patients who received Brigatinib experienced new or worsening hyperglycemia. Grade 3 hyperglycemia, based on laboratory assessment of serum fasting glucose levels, occurred in 3.7% of patients. Two of 20 (10%) patients with diabetes Brigatinib or glucose intolerance at baseline required initiation of insulin while receiving Brigatinib. Fasting serum glucose should be assessed prior to initiation of Brigatinib and monitored periodically thereafter. Antihyperglycemic medications should be initiated or optimized as needed. If adequate hyperglycemic control cannot be achieved with optimal medical management, Brigatinib should be withheld until adequate hyperglycemic control is achieved and considered reducing the dose of Brigatinib.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+1562,Brexpiprazole,brexpiprazole-1562,https://medex.com.bd/attachments/q2LRqDtAkd4pIqUgibEPecP6sJu3tl/brexpiprazole-prescribing-information,Benzodiazepine antagonist,Schizophrenia,"Brexpiprazole is an atypical antipsychotic indicated for:
+
+- Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD)
+- Treatment of schizophrenia
+
","Benzodiazepine antagonist
","The mechanism of action of brexpiprazole in the treatment of major depressive disorder or schizophrenia is unknown. However, the efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors.
","Adjunctive Treatment of Major Depressive Disorder: The recommended starting dosage for Brexpiprazole as adjunctive treatment is 0.5 mg or 1 mg once daily, taken orally with or without food. Titrate to 1 mg once daily, then up to the target dosage of 2 mg once daily. Dosage increases should occur at weekly intervals based on the patient's clinical response and tolerability. The maximum recommended daily dosage is 3 mg. Periodically reassess to determine the continued need and appropriate dosage for treatment.
Treatment of Schizophrenia: The recommended starting dosage for Brexpiprazole is 1 mg once daily on Days 1 to 4, taken orally with or without food. The recommended target Brexpiprazole dosage is 2 mg to 4 mg once daily. Titrate to 2 mg once daily on Day 5 through Day 7, then to 4 mg on Day 8 based on the patient’s clinical response and tolerability. The maximum recommended daily dosage is 4 mg.
",,,"Brexpiprazole is contraindicated in patients with a known hypersensitivity to brexpiprazole or any of its components. Reactions have included rash, facial swelling, urticaria, and anaphylaxis.
",,"There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Brexpiprazole during pregnancy.
Lactation studies have not been conducted to assess the presence of brexpiprazole in human milk, the effects of brexpiprazole on the breastfed infant, or the effects of brexpiprazole on milk production. Brexpiprazole is present in rat milk. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for Brexpiprazole and any potential adverse effects on the breastfed infant from Brexpiprazole or from the underlying maternal condition.
","Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-
+
+- Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g. stroke, transient ischemic attack)
+- Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring
+- Tardive Dyskinesia: Discontinue if clinically appropriate
+- Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia and weight gain
+- Pathological Gambling and Other Compulsive Behaviors: Consider dose reduction or discontinuation
+- Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts (CBC) in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. Consider discontinuing Brexpiprazole if a clinically significant decline in WBC occurs in absence of other causative factors
+- Orthostatic Hypotension and Syncope: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope
+- Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold
+
","Dosage Adjustments for Hepatic Impairment: For patients with moderate to severe hepatic impairment, the maximum recommended dosage is 2 mg once daily for patients with MDD, and 3 mg once daily for patients with schizophrenia
Dosage Adjustments for Renal Impairment: For patients with moderate, severe or end-stage renal impairment (creatinine clearance ClCr<60 mL/minute), the maximum recommended dosage is 2 mg once daily for patients with MDD and 3 mg once daily for patients with schizophrenia
Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients
Geriatric Use: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, and cardiac function, concomitant diseases, and other drug therapy.
",,,,"Store Brexpiprazole tablets at 20°C to 25°C; excursions permitted to 15°C to 30°C
",9
+1387,Bortezomib,bortezomib-1387,https://medex.com.bd/attachments/p3hux3ZMjWD5pRdYaOdWricu7rSMnI/bortezomib-prescribing-information,Targeted Cancer Therapy,Multiple myeloma,"Bortezomib is a proteasome inhibitor indicated for:
+
+- Treatment of patients with multiple myeloma
+- Treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy
+
","Targeted Cancer Therapy
","Bortezomib is a reversible inhibitor of the chymotrypsin-like activity of the 26S proteasome in mammalian cells. The 26S proteasome is a large protein complex that degrades ubiquitinated proteins. The ubiquitin-proteasome pathway plays an essential role in regulating the intracellular concentration of specific proteins, thereby maintaining homeostasis within cells. Inhibition of the 26S proteasome prevents this targeted proteolysis, which can affect multiple signaling cascades within the cell. This disruption of normal homeostatic mechanisms can lead to cell death. Experiments have demonstrated that bortezomib is cytotoxic to a variety of cancer cell types in vitro. Bortezomib causes a delay in tumor growth in vivo in nonclinical tumor models, including multiple myeloma.
","The recommended dose of Bortezomib is 1.3 mg/m2 administered as a 3 to 5 second bolus intravenous injection. Dose adjustment may be used to manage adverse events that occur during treatment
",,"Ketoconazole: Co-administration of ketoconazole, a potent CYP3A inhibitor, increased the exposure of bortezomib. Therefore, patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir).
Melphalan-Prednisone: Co-administration of melphalan prednisone increased the exposure of bortezomib. However, this increase is unlikely to be clinically relevant.
Omeprazole: Co-administration of omeprazole, a potent inhibitor of CYP2C19, had no effect on the exposure of bortezomib.
Cytochrome P450: Patients who are concomitantly receiving Bortezomib and drugs that are inhibitors or inducers of cytochrome P450 3A4 should be closely monitored for either toxicities or reduced efficacy
","Bortezomib is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol
","Most commonly reported adverse reactions (incidence ≥30%) in clinical studies include asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia and anemia. Other adverse reactions, including serious adverse reactions, have been reported
","Pregnancy Category D. Women of childbearing potential should avoid becoming pregnant while being treated with Bortezomib. Bortezomib administered to rabbits during organogenesis at a dose approximately 0.5 times the clinical dose of 1.3 mg/m2 based on body surface area caused post implantation loss and a decreased number of live fetuses.
","Women should avoid becoming pregnant while being treated with Bortezomib. Pregnant women should be apprised of the potential harm to the fetus
Peripheral neuropathy, including severe cases, may occur - manage with dose modification or discontinuation. Patients with preexisting severe neuropathy should be treated with Bortezomib only after careful risk-benefit assessment.
Hypotension can occur. Caution should be used when treating patients receiving antihypertensives, those with a history of syncope, and those who are dehydrated.
Patients with risk factors for, or existing heart disease, should be closely monitored.
Acute diffuse infiltrative pulmonary disease has been reported.
Nausea, diarrhea, constipation, and vomiting have occurred and may require use of antiemetic and antidiarrheal medications or fluid replacement.
Thrombocytopenia or neutropenia can occur; complete blood counts should be regularly monitored throughout treatment.
Tumor Lysis Syndrome, Reversible Posterior Leukoencephalopathy Syndrome, and acute hepatic failure have been reported.
",,,,,"Unopened vials may be stored at controlled room temperature 25º C
",10
+138,Bosentan Monohydrate,bosentan-monohydrate-138,https://medex.com.bd/attachments/3w3wC20Q67FJQR4TtnnhjoAuQSgiTx/bosentan-monohydrate-prescribing-information,Anti-hypertensive,Systemic sclerosis,"Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class Ill. Efficacy has been shown in: Some improvements have also been shown in patients with PAH WHO functional class ll.
","Anti-hypertensive, Endothelin receptor antagonist
","Bosentan is a dual endothelin receptor antagonist (ERA) with affinity for both endothelin A and B (ETA and ETB) receptors. Bosentan decreases both pulmonary and systemic vascular resistance resulting in increased cardiac output without increasing heart rate.
The neurohormone endothelin-1 (ET-1) is one of the most potent vasoconstrictors known and can also promote fibrosis, cell proliferation, cardiac hypertrophy and remodelling, and is pro-inflammatory. These effects are mediated by endothelin binding to ETA and ETB receptors located in the endothelium and vascular smooth muscle cells. ET-1 concentrations in tissues and plasma are increased in several cardiovascular disorders and connective tissue diseases, including pulmonary arterial hypertension, scleroderma, acute and chronic heart failure, myocardial ischaemia, systemic hypertension and atherosclerosis, suggesting a pathogenic role of ET-1 in these diseases. In pulmonary arterial hypertension and heart failure, in the absence of endothelin receptor antagonism, elevated ET-1 concentrations are strongly correlated with the severity and prognosis of these diseases
","Tablets are to be taken orally morning and evening, with or without food.
Pulmonary arterial hypertension: ln adult patients, Bosentan treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily.
For paediatric patients aged 2 years or older, the optimal maintenance dose has not been defined in well-controlled studies. However, paediatric pharmacokinetic data have shown that Bosentan plasma concentrations in children were on average lower than in adult patients and were not increased by increasing the dose of Bosentan above 2 mg/kg body weight twice daily.
Discontinuation of treatment: lf the decision to withdraw Bosentan is taken, it should be done gradually while an alternative therapy is introduced.
",,"Increased bosentan levels with CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, diltiazem), CYP2C9 inhibitors (e.g. amiodarone, fluconazole), tacrolimus. Rifampicin initially increases but subsequently decreases bosentan concentration. May decrease plasma levels of warfarin, statins (e.g. simvastatin, lovastatin), hormonal contraceptives, sildenafil, tadalafil.
","
+- Hypersensitivity to the active substance or to any of the excipients
+- Moderate to severe hepatic impairment, i.e., Child-Pugh class B or C.
+- Baseline values of liver aminotransferases, i.e., aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT), greater than 3 times the upper limit of normal
+- Concomitant use of cyclosporine A.
+- Pregnancy
+
+Special warnings and precautions for use Liver aminotransferase levels must be measured prior to initiation of treatment and subsequently at monthly intervals for the duration of treatment with Bosentan. ln addition, liver aminotransferase levels must be measured 2 weeks after any dose increase.
","Treatment with bosentan has been associated with dose dependent elevations in liver aminotransferases and decreases in haemoglobin concentration. Other side effects include Anaemia, haemoglobin decrease, Thrombocytopenia, Neutropenia, leucopenia, Hypersensitivity reactions, Headache, Syncope, Palpitations, Flushing, Hypotension, Gastroesophageal reflux disease, Aminotransferase elevations associated with hepatitis and/or jaundice, Liver cirrhosis, liver failure (rarely), Erythema, Diarrhoea, Oedema, fluid retention.
","Pregnancy: Bosentan is contraindicated in pregnancy.
Use during lactation: lt is not known whether bosentan is excreted into human breast milk. Breast-feeding is not recommended during treatment with Bosentan.
Effects on ability to drive and use machines: Bosentan may cause dizziness, which could affect the ability to drive or use machines.
","Consider discontinuation of therapy if pulmonary oedema occurs. Avoid abrupt withdrawal and consider dose reduction (e.g. half the dose for 3-7 days) to minimise risk of clinical deterioration. Lactation.
","Dosage in hepatic impairment: No dose adjustment is needed in patients with mild hepatic impairment. Bosentan is contraindicated in patients with moderate to severe liver dysfunction.
Dosage in renal impairment: No dose adjustment is required in patients with renal impairment. No dose adjustment is required in patients undergoing dialysis.
Dosage in elderly patients: No dose adjustment is required in patients over the age of 65 years.
","Symptoms: Nausea, vomiting, hypotension, dizziness, sweating and blurred vision.
Management: Symptomatic and supportive treatment.
",,,"Store below 30°C. Store in a cool and dry place, protected from light. Keep out of children’s reach.
",12
+137,Bleomycin Sulfate,bleomycin-sulfate-137,https://medex.com.bd/attachments/ehAYOmrBtiZf2bmDkHRaPFCatKfkpL/bleomycin-sulfate-prescribing-information,Cytotoxic Chemotherapy,Testicular cancer,"Bleomycin sulfate should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents:
Squamous Cell Carcinoma: Head and neck ... Read more
Bleomycin sulfate should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents:
Squamous Cell Carcinoma: Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. The response to Bleomycin sulfate is poorer in patients with previously irradiated head and neck cancer.
Lymphomas: Hodgkin’s disease, non-Hodgkin’s lymphoma.
Testicular Carcinoma: Embryonal cell, choriocarcinoma, and teratocarcinoma. Bleomycin sulfate has also been shown to be useful in the management of Malignant Pleural Effusion
","Cytotoxic Chemotherapy
","Although the exact mechanism of action of bleomycin sulfate is unknown, available evidence indicates that the main mode of action is the inhibition of DNA synthesis with some evidence of lesser inhibition of RNA and protein synthesis.
Bleomycin is known to cause single, and to a lesser extent, double-stranded breaks in DNA. In in vitro and in vivo experiments, bleomycin has been shown to cause cell cycle arrest in G2 and in mitosis. When administered into the pleural cavity in the treatment of malignant pleural effusion, bleomycin sulfate acts as a sclerosing agent.
","Because of the possibility of an anaphylactoid reaction, lymphoma patients should be treated with 2 units or less for the first 2 doses. If no acute reaction occurs, then the regular dosage schedule may be followed.
Squamous cell carcinoma, non-Hodgkin’s lymphoma, testicular carcinoma: 0.25 to 0.50 units/kg (10 to 20 units/m2) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly.
Hodgkin’s disease: 0.25 to 0.50 units/kg (10 to 20 units/m2) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly. After a 50% response, a maintenance dose of 1 unit daily or 5 units weekly intravenously or intramuscularly should be given.
Pulmonary toxicity of Bleomycin sulfat appears to be dose-related with a striking increase when the total dose is over 400 units. Total doses over 400 units should be given with great caution.
Note: When Bleomycin sulfat is used in combination with other antineoplastic agents, pulmonary toxicities may occur at lower doses.
Improvement of Hodgkin’s disease and testicular tumors is prompt and noted within 2 weeks. If no improvement is seen by this time, improvement is unlikely. Squamous cell cancers respond more slowly, sometimes requiring as long as 3 weeks before any improvement is noted.
Malignant Pleural Effusion: 60 units administered as a single dose bolus intrapleural injection
",,"Increased incidence and severity of lung toxicity with previous or concurrent radiotherapy to the chest. Combination with vinca alkaloids may result to a syndrome corresponding to morbus Raynaud, ischaemia which can lead to necrosis of peripheral parts of the body (fingers, toes, nose tip). May reduce the absorption of phenytoin. Increased risk of agranulocytosis with clozapine.
","Acute pulmonary infection or greatly reduced lung function. Concomitant brentuximab, cisplatin or oxygen. Lactation.
","Common side effects of Bleomycin Sulfate include injection site reactions (pain, redness, warmth, itching, or swelling), fever, chills, vomiting, loss of appetite, weight loss, darkening or discoloration of the skin, changes in fingernails or toenails, itching, or pain near your tumor.
","Pregnancy Category D. It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, it is recommended that nursing be discontinued by women receiving Bleomycin Sulfate therapy.
","Caution should be taken in patient with severe heart disease, Renal impairment, Elderly & Pregnancy.
","Pediatric Use: Safety and effectiveness of Bleomycin in pediatric patients have not been established.
Geriatric Use: In clinical trials, pulmonary toxicity was more common in patients older than 70 years than in younger patients
","Symptoms: Hypotension, fever, rapid pulse and general symptoms of shock.
Management: Symptomatic. In case of resp complications, treat with a corticosteroid and a broad-spectrum antibiotic.
",,"IM/SC: Add 1-5 mL or 2-10 mL of sterile water for inj, NaCl 0.9% inj, or bacteriostatic water for inj to the vial labelled as containing 15 IU or 30 IU of bleomycin, respectively, to provide a soln containing 3-15 IU/mL.
IV: Add 5 mL or 10 mL of NaCl 0.9% into the vial labelled as containing 15 IU or 30 IU of bleomycin, respectively, to provide a soln containing ≤3 IU/mL. Admin slowly over a 10-min period. Intrapleural: Dissolve 60 IU of bleomycin in 50-100 mL NaCl 0.9% inj.
","Store between 2-8°C. Protect from light and should not be used after the expiration date is reached.
",13
+1475,Bivalirudin,bivalirudin-1475,https://medex.com.bd/attachments/vBAuOJVOPezE9tBkarq0sGgn0xgdl2/bivalirudin-prescribing-information,Anti-platelet drugs,Unstable angina,"Bivalirudin is indicated for:
+
+- Anticoagulant in Patients Undergoing PTCA/PCI or PCI with HITS/HITTS
+- Unstable Angina/Non-ST-Elevation MI (Off-label)
+- STEMI Undergoing Primary PCI (Off-label)
+- Heparin-induced Thrombocytopenia
+
","Anti-platelet drugs
","Bivalirudin directly inhibits thrombin by specifically binding both to the catalytic site and to the anion-binding exosite of circulating and clot-bound thrombin. Thrombin is a serine proteinase that plays a central role in the thrombotic process, acting to cleave fibrinogen into fibrin monomers and to activate Factor XIII to Factor XIIIa, allowing fibrin to develop a covalently cross-linked framework which stabilizes the thrombus; thrombin also activates Factors V and VIII, promoting further thrombin generation, and activates platelets, stimulating aggregation and granule release. The binding of bivalirudin to thrombin is reversible as thrombin slowly cleaves the bivalirudin-Arg3-Pro4 bond, resulting in recovery of thrombin active site functions.
In in vitro studies, bivalirudin inhibited both soluble (free) and clot-bound thrombin, was not neutralized by products of the platelet release reaction, and prolonged the activated partialthromboplastin time (aPTT), thrombin time (TT), and prothrombin time (PT) of normal human plasma in a concentration-dependent manner. The clinical relevance of these findings is unknown.
","PCI/PTCA: IV Bolus dose of 0.75 mg/kg followed by an infusion of 1.75 mg/kg/h for duration of PCI procedure. Five minutes after bolus dose, obtain ACT and administer additional bolus of 0.3 mg/kg if indicated.
HIT/HITTS: IV Bolus dose of 0.75 mg/kg, followed by a continuous infusion at a rate of 1.75 mg/kg/h for the duration of the procedure.
Continuation of Therapy: IV Infusion may be continued for up to 4 h post-procedure as indicated. After 4 h, an additional IV infusion of 0.2 mg/kg/h for up to 20 h may be given if needed.
Concomitant Therapy: Bivalirudin is intended for concurrent use with aspirin (300 to 325 mg/day).
","
+- For IV administration only. Not for intradermal, subcutaneous, IM, or intra-arterial administration.
+- Reconstitute powder for injection with 5 mL sterile water for injection. Gently swirl until powder is dissolved.
+- For initial bolus infusion, further dilute each reconstituted via in 50 mL of 5% dextrose in water or sodium chloride 0.9% for injection to yield a final concentration of 5 mg/mL.
+- For low rate infusion, further dilute each reconstituted vial in 500 mL of 5% dextrose in water or sodium chloride 0.9% for injection to yield a final concentration of 0.5 mg/mL.
+- Do not mix with the following drugs in the same IV line: alteplase, amiodarone, amphotericin B, chlorpromazine, diazepam, dobutamine, prochlorperazine, reteplase, streptokinase, vancomycin.
+- Reconstituted bivalirudin should be a clear to slightly opalescent, colorless to slightly yellow solution. Do not administer if reconstituted or diluted solution is discolored, cloudy, or contains particulate matter.
+- Maintain meticulous catheter technique, with frequent aspiration and flushing, paying special attention to minimizing conditions of stasis within the catheter or vessels.
+- Discard any unused reconstituted or diluted solution.
+
","Co-administration of Bivalirudin with heparin, warfarin, thrombolytics, or GPIs was associated with increased risks of major bleeding events.
","Bivalirudin is contraindicated in patients with: Active major
bleeding & Hypersensitivity (e.g., anaphylaxis) to Bivalirudin or its components
","
+- Bleeding, Body as a Whole: fever,infection, sepsis;
+- Cardiovascular: hypotension, syncope, vascular anomaly,ventricular fibrillation;
+- Nervous: cerebral ischemia, confusion, facialparalysis;
+- Respiratory: lung edema;
+- Urogenital: kidney failure, oliguria.
+
","Pregnancy Category B. No adequate and well-controlled studies in pregnant women. As animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Bivalirudin is intended for use with aspirin . Because of possible adverse effects on the neonate and the potential for increased maternal bleeding, particularly during the third trimester, Bivalirudin and aspirin should be used together during pregnancy only if clearly needed.
Nursing Mothers: It is not known whether bivalirudin is excreted in human milk. As many drugs are excreted in human milk, caution should be exercised when Bivalirudin is administered to a nursing woman.
","Bleeding Events: Although most bleeding associated with the use of Bivalirudin in PCI/PTCA occurs at the site of arterial puncture, hemorrhage can occur at any site. An unexplained fall in blood pressure or hematocrit should lead to serious consideration of a hemorrhagic event and cessation of Bivalirudin administration. Bivalirudin should be used with caution in patients with disease states associated with an increased risk of bleeding.
Coronary Artery Brachy therapy: An increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Bivalirudin in gamma brachytherapy. If a decision is made to use Bivalirudin during brachytherapy procedures, maintain meticulous catheter technique, with frequent aspiration and flushing, paying special attention to minimizing conditions of stasis within the catheter or vessels.
","Renal Impairment: The clearance of Bivalirudin was reduced approximately 20% in patients with moderate and severe renal impairment and was reduced approximately 80% in dialysis-dependent patients.The infusion dose of Bivalirudin may need to be reduced, and anticoagulant status monitored in patients with renal impairment
+
+- ClCr 30 to 50 mL/min: Administer infusion at rate of 1.75 mg/kg/h.
+- ClCr less than 30 mL/min: Reduce infusion rate to 1 mg/kg/h.
+
+
Hemodialysis: Reduce infusion rate to 0.25 mg/kg/h. No reduction in bolus dose needed.
Pediatric Use: The safety and effectiveness of Bivalirudin in pediatric patients have not been established.
Geriatric Use: Elderly patients experienced more bleeding events than younger patients. Patients treated with Bivalirudin experienced fewer bleeding events in each age stratum, compared to heparin.
","Cases of overdose of up to 10 times the recommended bolus or continuous infusion dose of Bivalirudin have been reported in clinical trials and in postmarketing reports. A number of the reported overdoses were due to failure to adjust the infusion dose of bivalirudin in persons with renal dysfunction including persons on hemodialysis . Bleeding, as well as deaths due to hemorrhage, have been observed in some reports of overdose. In cases of suspected overdosage, discontinue Bivalirudin immediately and monitor the patient closely for signs of bleeding. There is no known antidote to Bivalirudin. Bivalirudin is hemodialyzable
",,"Do not freeze reconstituted or diluted Bivalirudin. Reconstituted material may be stored at 2-8º C for up to 24 hours. Diluted Bivalirudin with a concentration of between 0.5 mg/mL and 5 mg/mL is stable at room temperature for up to 24 hours. Discard any unused portion of reconstituted solution remaining in the vial.
","Store at temperature not exceeding 30º C in a dry place. Do not freeze. Keep out of reach of children
",14
+135,Bisoprolol Hemifumarate,bisoprolol-hemifumarate-135,https://medex.com.bd/attachments/5zKjMca29QvFRGFc9U8ctwX46ZDM6N/bisoprolol-hemifumarate-prescribing-information,Anti adrenergic agent (Beta blockers),Hypertension,"Bisoprolol is indicated in-
+
+- Hypertension
+- Angina
+- Moderate to severe heart failure
+
+Bisoprolol is not recommended for the emergency treatment of hypertensive crises.
","Anti adrenergic agent (Beta blockers), Beta-adrenoceptor blocking drugs, Beta-blockers
","Bisoprolol Hemifumarate is the most selective ß1 blocker. It displays highest level of affinity for the ß1 receptor than any other beta-blocker available up to now. Selectively blocks ß1 adrenergic receptor in the heart and vascular smooth muscle and reduces heart rate and cardiac output resulting in decrease of arterial hypertension. Lipid metabolism can be adversely affected by ß-blockers, in patients with non-ß1 selective ß1-blocker, but Bisoprolol does not cause any change in the cholesterol fraction including the cardioprotective HDL-cholesterol, in long-term therapy.
","Adult: In the treatment of mild to moderate hypertension, Bisoprolol fumarate must be individualized to the needs of the patient. The usual starting dose is 5 mg once daily either added to a diuretic or alone. If the response to 5 mg is inadequate, the dose may be increased to 10 mg and then, if necessary, to 20 mg once daily. An appropriate interval for dose titration is 2 weeks. Increasing the dose beyond 20 mg once daily produces only a small incremental benefit.
Children: Safety and effectiveness in children have not been established.
Patients With Renal or Hepatic Impairment: In patients with hepatic impairment (hepatitis or cirrhosis) or renal dysfunction (creatinine clearance less than 40 mL/min) as in other patients, the initial daily dose should be 5 mg. Because of the possibility of accumulation, caution must be used in dose titration. Since limited data suggest that bisoprolol fumarate is not dialysable, drug replacement is not necessary in patients undergoing dialysis.
Geriatrics: In the elderly, it is not usually necessary to adjust the dose, unless there is also significant renal or hepatic dysfunction
",,"Other β-blocking Agents: Bisoprolol fumarate should not be combined with other β-blocking agents.
Catecholamine-Depleting Drugs: Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be monitored closely because the added β-adrenergic blocking action of bisoprolol fumarate may produce excessive reduction of sympathetic activity.
Centrally Active Antihypertensive Agents: β-blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two drugs are coadministered, the β-blocker should be withdrawn several days before discontinuing clonidine. If replacing clonidine by β-blocker therapy, the introduction of β-blockers should be delayed for several days after clonidine administration has stopped (see also prescribing information for clonidine).
Antiarrhythmic Agents: Bisoprolol fumarate should be used with care when myocardial depressants or inhibitors of A-V conduction, such as certain calcium antagonists (particularly of the phenyl alkylamine (verapamil) and benzothiazepine (diltiazem) classes), or antiarrhythmic agents, such as disopyramide, are used concurrently.
Calcium Channel Blockers: Combined use of β-blockers and calcium channel blockers with negative inotropic effects can lead to prolongation of S-A and A-V conduction, particularly in patients with impaired ventricular function or conduction abnormalities. This may result in severe hypotension, bradycardia and cardiac failure.
","In patients with cardiogenic shock, overt heart failure, second or third degree A-V block, right ventricular failure secondary to pulmonary hypertension and sinus bradycardia.
","Bisoprolol, like any medication, may have some side effects. It is important that you keep your doctor informed of all side effects especially if you experience one of the following for several days. The most common side effects, whether or not caused by Bisoprolol, are: headache, fatigue, urinary tract infection, rhinitis or sinusitis (inflammation in the nose), diarrhea, dizziness, peripheral edema (swelling of the ankles), joint pain, cough, insomnia (trouble sleeping), nausea (feeling like vomiting), and sore throat. You must seek medical attention immediately if you experience an allergic reaction with symptoms of rash, itching, swelling, dizziness or trouble breathing.
Medicines affect different people in different ways. Just because side effects have occurred in other patients does not mean you will get them. Discuss how you feel on Bisoprolol with your doctor or pharmacist. Do not stop or restart Bisoprolol on your own.
","Pregnancy: Bisoprolol fumarate was not teratogenic in rats at doses up to 150 mg/kg/day, which is 375 times the maximum recommended human daily dose. Bisoprolol fumarate was fetotoxic (increased late resorptions) at 50 mg/kg/day and maternotoxic (decreased food intake and body-weight gain) at 150 mg/kg/day. Bisoprolol fumarate was not teratogenic in rabbits at doses up to 12.5 mg/kg/day, which is 31 times the maximum recommended human daily dose, but was embryolethal (increased early resorptions) at 12.5 mg/kg/day. There are no studies in pregnant women. Bisoprolol fumarate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: Small amounts of bisoprolol fumarate (<2% of the dose) have been detected in the milk of lactating rats. It is not known whether this drug is excreted in human milk. If use of bisoprolol fumarate is considered essential, then mothers should stop nursing.
","Monitoring of renal, hepatic and hematopoietic function should be performed at regular intervals during long-term treatment with bisoprolol.
",,,,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",10
+136,Bisoprolol Fumarate + Hydrochlorothiazide,bisoprolol-fumarate-hydrochlorothiazide-136,https://medex.com.bd/attachments/qxJNaIAclWBPkGE3aqelqlXJY16r34/bisoprolol-fumarate-hydrochlorothiazide-prescribing-information,Combined antihypertensive preparations,Hypertension,"Bisoprolol plus Hydrochlorothiazide is indicated in the treatment of Hypertension.
","Combined antihypertensive preparations
","Bisoprolol Fumarate and Hydrochlorothiazide have been used individually and in combination for the treatment of hypertension. The antihypertensive effects of these agents are additive; Hydrochlorothiazide 6.25 mg significantly increases the antihypertensive effect of Bisoprolol Fumarate. The incidence of hypokalemia with the Bisoprolol Fumarate and Hydrochlorothiazide 6.25 mg combination is significantly lower than with Hydrochlorothiazide 25 mg. Bisoprolol Fumarate is a β1-selective (cardioselective) adrenoceptor blocking agent without significant membrane stabilizing or intrinsic sympathomimetic activities in its therapeutic dose range. Hydrochlorothiazide is a benzothiadiazine diuretic. Thiazides affect renal tubular mechanisms of electrolyte reabsorption and increase excretion of sodium and chloride in approximately equivalent amounts
","Bisoprolol is an effective treatment of hypertension in once-daily doses of 2.5 to 40 mg, while Hydrochlorothiazide is effective in doses of 12.5 to 50 mg. In clinical trials of Bisoprolol/Hydrochlorothiazide combination therapy using Bisoprolol doses of 2.5 to 20 mg and Hydrochlorothiazide doses of 6.25 to 25 mg, the antihypertensive effects increased with increasing doses of either component.
Initial Therapy: Antihypertensive therapy may be initiated with the lowest dose of this conbination, one 2.5/6.25 mg tablet once daily. Subsequent titration (14 day intervals) may be carried out with this tablets up to the maximum recommended dose 20/12.5 mg once daily, as appropriate.
Replacement Therapy: The combination may be substituted for the titrated individual components.
Therapy Guided by Clinical Effect: A patient whose blood pressure is not adequately controlled with 2.5-20 mg Bisoprolol daily may instead be given this conbination. Patients whose blood pressures are adequately controlled with 50 mg of hydrochlorothiazide daily, but who experience significant potassium loss with this regimen, may achieve similar blood pressure control without electrolyte disturbance if they are switched to this conbination.
",,"This combination drug may potentiate the action of other antihypertensive agents used concomitantly. This combination drug should not be combined with other beta-blocking agents. Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be closely monitored because the added beta-adrenergic blocking action of Bisoprolol Fumarate may produce excessive reduction of sympathetic activity. In patients receiving concurrent therapy with clonidine, if therapy is to be discontinued, it is suggested that this combination drug be discontinued for several days before the withdrawal of clonidine. This combination drug should be used with caution when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes) or antiarrhythmic agents, such as disopyramide, are used concurrently. Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
","It is contraindicated in patients in cardiogenic shock, overt cardiac failure, second or third degree AV block, marked sinus bradycardia, anuria and hypersensitivity to either component of this product or to other sulfonamide-derived drugs.
","Generally well tolerated. Most side effects have been mild and transient. Side effects which may occur: fatigue, dizziness, headache, bradycardia, arrhythmia, peripheral ischemia, chest pain, palpitations, rhythm disturbances, cold extremities, claudication, orthostatic hypotension, diarrhoea, constipation, nausea, dyspepsia, rhinitis, pharyngitis etc.
","Use in Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Bisoprolol Fumarate and Hydrochlorothiazide should be used during pregnancy only if the potential benefit justifies the risk to the fetus.
Use in Nursing Mothers: Bisoprolol Fumarate alone or in combination with Hydrochlorothiazide has not been studied in nursing mothers. Thiazides are excreted in human breast milk. Small amounts of Bisoprolol Fumarate have been detected in the milk of lactating rats. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","Hyperuricemia or acute gout may be precipitated in certain patients receiving thiazide diuretics. Warning signs or symptoms of fluid and electrolyte imbalance include dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia and gastrointestinal disturbances such as nausea and vomiting. Hypokalemia may develop. If withdrawal of this combination therapy is planned, it should be achieved gradually over a period of about 2 weeks. Patients should be carefully observed.
",,"There are limited data on overdose with this combination product. The most frequently observed signs expected with overdosage of a beta-blocker are bradycardia and hypotension. Lethargy is also common and with severe overdoses, delirium, coma, convulsions, and respiratory arrest have been reported to occur. Congestive heart failure, bronchospasm, and hypoglycemia may occur. With thiazide diuretics, acute intoxication is rare. The most prominent feature of overdose is acute loss of fluid and electrolytes. Signs and symptoms include cardiovascular (tachycardia, hypotension, shock), neuromuscular (weakness, confusion, dizziness, cramps of the calf muscles, paresthesia, fatigue, impairment of consciousness), gastrointestinal (nausea, vomiting, thirst), renal (polyuria, oliguria, or anuria), and laboratory findings (hypokalemia, hyponatremia, hypochloremia, alkalosis, increased BUN [especially in patients with renal insufficiency]).
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+1433,Bisoprolol Fumarate + Amlodipine Besilate,bisoprolol-fumarate-amlodipine-besilate-1433,,Anti-hypertensive,Hypertension,"Bisoprolol & Amlodipine combination is indicated for the treatment of hypertension as substitution therapy in patients adequately controlled with the individual products given concurrently at the same dose level as in the combination, but as separate tablets
","Anti-hypertensive
","This consists of Amlodipine and Bisoprolol Fumarate. Amlodipine is a dihydropyridine calcium antagonist that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine acts directly on vessels to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
Bisoprolol Fumarate is a synthetic, beta1-selective (cardioselective) adrenoceptor blocking agent, lacking intrinsic sympathomimetic and relevant membrane stabilizing activity. It only shows low affinity to the beta2 receptor of the smooth muscles of bronchi and vessels as well as to the beta2-receptors concerned with metabolic regulation. Therefore, bisoprolol is generally not to be expected to influence airway resistance and beta2-mediated metabolic effects. Its beta1-selectivity extends beyond the therapeutic dose range.
","One tablet once daily in patients whose blood pressure is adequately controlled with separately administered monocomponent products of the same doses as the recommended fixed-dose combination.
",,"Combinations not recommended: Calcium antagonists of the verapamil and diltiazem type, centrally-acting antihypertensive drugs.
Combinations to be used with caution: Strong or moderate CYP3A4 inhibitors, CYP3A4 inducers, simvastatin, Tacrolimus, Cyclosporine, class I antiarrhythmic drugs, class III antiarrhythmic drugs, parasympathomimetic drugs, topical beta-blockers (e.g. eye drops), insulin and oral antidiabetic drugs, anesthetic agents, digitalis glycosides, non-steroidal anti-inflammatory drugs (NSAIDs), sympathomimetic agents, antihypertensive agents and other drugs with blood pressure lowering potential.
Combinations to be considered: Mefloquine, Rifampicin, Ergotamine derivatives, MAO inhibitors (except MAO-B inhibitor).
","Acute heart failure or during episodes of heart failure decompensation, obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis), cardiogenic shock, second or third degree AV block, sick sinus syndrome, sinoatrial block, symptomatic bradycardia or hypotension, severe bronchial asthma, severe forms of peripheral arterial occlusive disease or severe forms of Raynaud’s syndrome, untreated phaeochromocytoma metabolic acidosis, hypersensitivity to bisoprolol, amlodipine, dihydropyridine derivates or to any of the excipients.
","Common: Dizziness, headache, somnolence, palpitations, flushing, feeling of coldness or numbness in the extremities, gastrointestinal complaints such as nausea, vomiting, diarrhea, constipation, abdominal pain; edema (e.g. ankle edema), fatigue.
Uncommon: Insomnia, mood changes (incl. anxiety), depression, sleep disorders, hypaesthesia, paresthesia, dysgeusia, tremor, visual disturbances (incl. diplopia), tinnitus, AV conduction disturbances, worsening of pre existing heart failure, bradycardia, hypotension, syncope, dyspnea, bronchospasm in patients with bronchial asthma or a history of obstructive airway disease, rhinitis, dyspepsia, dry mouth, alopecia, purpura, skin discoloration, pruritus, exanthema, arthralgia, myalgia, muscular weakness, muscle cramps, back pain, micturition disorder, nocturia, pollakisuria, potency disorders, gynecomastia, asthenia, chest pain, pain, malaise, weight increase, weight decrease.
Rare: Allergic reactions mainly affecting the skin, nightmares, hallucinations, confusion, decreased tear secretion, hearing disorders, allergic rhinitis, hepatitis, increased triglycerides, increased liver enzymes (ALAT, ASAT).
","Pregnancy and Lactation: Not recommended.
","Patients with heart failure should be treated with caution. An increased risk of a further deterioration of the ventricular pump function cannot be excluded. Since the abrupt withdrawal of bisoprolol may lead to a transitory worsening of the clinical condition, especially in patients with ischemic heart disease, the treatment must not be stopped abruptly. Caution is advised in patients with impaired hepatic function. Beta-blockers should be avoided in patients with obstructive airways diseases unless there are compelling clinical reasons for their use. Due to the bisoprolol component treatment must be used with caution in: bronchospasm (bronchial asthma, chronic obstructive airways disease; concomitant bronchodilating therapy may be recommended); diabetes mellitus showing large fluctuations in blood glucose values, symptoms of hypoglycemia can be masked; strict fasting; ongoing desensitization therapy; first degree AV block; Prinzmetal’s angina; peripheral arterial occlusive disease. Patients with psoriasis or with a history of psoriasis should only be given beta-blockers (e.g. bisoprolol) after a careful balancing of benefits and risks. Symptoms of thyrotoxicosis may be masked. In patients undergoing general anesthesia, the anesthetist must be aware of beta-blockade. If it is thought necessary to withdraw beta blocker therapy before surgery, this should be done gradually and completed about 48 hours before anesthesia.
","Geriatric use: The usual doses can be administered to elderly people; however, caution is advised when the dose is increased.
Pediatric use: The safety and efficacy of Bisoprolol fumarate/amlodipine in children and adolescents below the age of 18 years have not been established. No data are available.
Patients with Liver disease: In case of hepatic impairment elimination of amlodipine may be elongated. Exact dosage recommendations concerning amlodipine have not been established, but the drug should therefore be administered with special caution in these patients. In case of severe hepatic impairment, the daily dose of bisoprolol must not exceed 10 mg.
Patients with Kidney disease: No dosage adjustment is required for patients with mild to moderate renal impairment. Amlodipine is not dialyzable. Amlodipine should be administered with particular caution to patients undergoing dialysis. In case of severe renal impairment (creatinine clearance <20 ml/min) the daily dose of bisoprolol must not exceed 10 mg
","Most common signs expected with overdose of a beta-blocker are bradycardia, hypotension, bronchospasm, acute cardiac insufficiency, hypoglycemia. According to available data gross overdose of amlodipine could result in excessive peripheral vasodilation and possibly reflex tachycardia. Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome have been reported. In general, if overdose occurs, discontinuation of treatment and supportive and symptomatic treatment is recommended.
",,,"Keep in a dry place, below 30°C. Protect from light. Keep out of the reach of children.
",12
+134,Bismuth Subsalicylate,bismuth-subsalicylate-134,https://medex.com.bd/attachments/ruqeSx8slzgRyOn7AJL4WM46Ne7qYZ/bismuth-subsalicylate-prescribing-information,,,"Bismuth Subsalicylate is indicated for-
+
+- upset stomach
+- indigestion
+- heartburn
+- nausea and
+- diarrhea.
+
",,"Antacid action: Bismuth Subsalicylate coats ulcer surface, protecting it from acid and pepsin. It stimulates mucus and bicarbonate secretion and also reacts with HCl, produces bismuth oxychloride and salicylic acid thus reduces HCl.
Anti-diarrheal action: It stimulates absorption of water and electrolytes across the intestinal wall. In infectious diarrhea it binds with toxin produced by E.coli, disrupts cell, causing lysis of H.pylori and prevents adhesion of H.pylori in the cell wall of intestine.
Anti-inflammatory action: When hydrolyzed to salicylic acid, it inhibits prostaglandin G/H synthase ½. Thus reduces inflammation and Coats the irritated tissue to retard the expulsion of fluid.
","Adult (>16): 30 ml in dosing cup provided or 6x5 ml spoonful
Children (10-14 years): 15 mL (3 teaspoons)
Children (5-9 years): 7.5 mL (1.5 teaspoons)
Children (3-4 years): 5 mL (1 teaspoon)
Children under 3 years: Ask a doctor.
Use in the elderly: No special precaution is needed.
Patient is suffering from renal insufficiency: caution should be taken.
Repeat dose every ½ to 1 hour if needed. Not more than 8 doses to be taken in 24 hours.
",,"Bismuth Subsalicylate Contains salicylates therefore care should be exercised if receiving drugs to thin the blood (anticoagulant therapy) or oral therapy for diabetes or treatment for gout or arthritis.
","Bismuth Subsalicylate should not be used by patients hypersensitive to Aspirin or other salicylates or any ingredient in this formulation. Keep all medicines out of reach and sight of children.
","Black stool and black tongue is common with use of Bismuth Subsalicylate. Bismuth Subsalicylate should not be used if symptoms are severe or persist for more than 2 days. Do not exceed the recommended dose, shake the bottle before use. For oral use only.
","There are no adequate data concerning the use of Bismuth Subsalicylate in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition and postnatal development. The potential risk for humans is unknown. Bismuth Subsalicylate should not be used during lactation unless clearly necessary.
","Do not take with aspirin or other salicylates. Caution should be exercised by patients taking medicines for anti-coagulation (thinning of the blood), diabetes or gout.
",,"Bismuth intoxication may present as an acute encephalopathy with confusion, myoclonic movements, tremor, dysarthria and walking and standing disorders. Bismuth intoxication may also cause gastrointestinal disturbances, skin reactions, discoloration of mucous membranes, and renal dysfunction as a result of acute tubular necrosis. Treatment includes gastric lavage, purgation and hydration. Chelating agents may be effective in the early stages following ingestion and haemodialysis may be necessary. Overdose of Bismuth Subsalicylate may also give symptoms of salicylate intoxification e.g. dizziness, tinnitus, sweating, nausea, headache. If symptoms occur, use of Bismuth Subsalicylate should be discontinued. Management of overdose is the same as that for salicylate overdose.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+99,Azilsartan Medoxomil,azilsartan-medoxomil-99,https://medex.com.bd/attachments/WuUIVKqfenn30Aa0AG68n3P8xAcaTf/azilsartan-medoxomil-prescribing-information,Angiotensin-ll receptor blocker,Hypertension,"Azilsartan Medoxomil is indicated for the treatment of hypertension to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily stroke and myocardial infarction. Azilsartan Medoxomil may be used either alone or in combination with other antihypertensive agents.
","Angiotensin-ll receptor blocker
","Azilsartan Medoxomil, a prodrug, is hydrolyzed to Azilsartan in the gastrointestinal tract during absorption. Azilsartan is a selective AT1 subtype angiotensin II receptor antagonist. Azilsartan blocks the vasoconstrictor and aldosterone secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland.
","The recommended dose in adults is 80 mg taken orally once daily. Consider a Starting dose of 40 mg for patients who are treated with high doses of diuretics. If blood pressure is not controlled with Azilsartan alone, additional blood pressure reduction can be achieved by taking Azilsartan with other antihypertensive agents.
",,"No drug interactions have been observed in studies of Azilsartan Medoxomil or Azilsartan given with amlodipine, antacids, chlorthalidone, digoxin, fluconazole, glyburide, ketoconazole, metformin, pioglitazone and warfarin. The antihypertensive effect of Azilsartan may be attenuated by the non-steroidal anti-inflammatory drugs including selective COX-2 inhibitors. Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors or aliskiren is associated with increased risks of hypotension, hyperkalemia and changes in renal function.
","It is contraindicated to co-administer Aliskiren with Azilsartan in patients with Diabetes.
","The most common adverse reaction in adults is diarrhea. The other side effects are nausea, asthenia, fatigue, muscle spasm, dizziness and cough.
","Pregnancy Category D. The risk to the fetus increases if Azilsartan Medoxomil is administered during the second or third trimesters of pregnancy. It is not known whether Azilsartan Medoxomil is excreted in human milk, as many drugs are excreted in human milk and because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
","Use of Azilsartan Medoxomil during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. In patients who are intravascularly volume-depleted (e.g., those treated with high-dose diuretics), symptomatic hypotension may occur. Changes in renal function including renal failure has been reported in renal impaired patient.
","Safety and effectiveness in pediatric patients under 18 years of ages have not been established.
","Limited data are available related to overdose in humans. In the event of and overdose, supportive therapy should be instituted as dictated by the patient’s clinical status. Azilsartan is not dialyzable.
",,,"keep in a dry place away from light and heat. Keep out of the reach of children.
",12
+1300,Azelastine Hydrochloride + Fluticasone Propionate,azelastine-hydrochloride-fluticasone-propionate-1300,https://medex.com.bd/attachments/SDEmVEoCy7JFkNgsKEMasU5ohiENlt/azelastine-hydrochloride-fluticasone-propionate-prescribing-information,Nasal Steroid Preparations,Perennial or seasonal allergic rhinitis,"Azelastine and Fluticasone Nasal Spray is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 6 years of age and older who require treatment with both Azelastine Hydrochloride and Fluticasone Propionate for symptomatic relief.
","Nasal Steroid Preparations
","Azelastine Hydrochloride exhibits histamine H1-receptor antagonist activity in isolated tissues. The major metabolite, desmethylazelastine, also possesses H1-receptor antagonist activity. Fluticasone Propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. The precise mechanism through which Fluticasone Propionate affects allergic rhinitis symptoms is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes etc.) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation.
","Adult: The recommended dosage is one spray each nostril twice daily.
Paediatric: The safety and effectiveness of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray has not been established for patients less than 6 years of age.
","How to use the Nasal Spray-
+
+- Shake the bottle gently and remove the dust cover.
+- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
+- Gently blow the nose to clear the nostrils.
+- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
+- Breathe out through your mouth.
+- Repeat the above steps in the same/ other nostril for consecutive doses.
+
+Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-
+
+- Remove the dust cover.
+- Gently pull off the nasal applicator.
+- Wash the applicator and dust cover in warm water.
+- Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
+- Gently push the applicator back on the top of the bottle and re-fix the dust cover.
+
",,"There is no known contraindication.
","The most common adverse reactions (>2% incidence) are: dysgeusia, epistaxis, and headache.
","Pregnancy category C. There are no adequate and well-controlled clinical trials of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray, Azelastine Hydrochloride only or Fluticasone Propionate only in pregnant women. It should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when administered to a nursing woman.
","Engagement in hazardous occupations requiring complete mental alertness such as driving or operating machinery should be avoided when taking Azelastine and Fluticasone Nasal Spray. Concurrent use of alcohol or other central nervous system (CNS) depressants with this Nasal Spray should also be avoided because of further decreased alertness and impairment of CNS. Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals may appear. If such changes occur, the spray should be discontinued slowly.
",,"There have been no reported over dosages with Azelastine Hydrochloride. Acute Azelastine Hydrochloride overdosage by adults with this dosage form is unlikely to result in clinically significant adverse events, other than increased somnolence. Chronic Fluticasone Propionate overdosage may result in symptoms of hypercorticism.
",,,"Store below 25° C. Protected from light. Do not store in the refrigerator. Keep out of the reach of children.
",11
+98,Azelastine Hydrochloride (Nasal Spray),azelastine-hydrochloride-nasal-spray-98,https://medex.com.bd/attachments/lFLdFYD5CouqaD3zsJQ88EbSQ3v6tC/azelastine-hydrochloride-nasal-spray-prescribing-information,Nasal Anti-histamine preparations,Vasomotor rhinitis,"Azelastine Hydrochloride nasal spray is an H1-receptor antagonist indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.
","Nasal Anti-histamine preparations
","Azelastine, a phthalazinone derivative, exhibits histamine H1 receptor antagonist activity in isolated tissues, animal models and humans. It is administered as a racemic mixture with no difference in pharmacologic activity noted between the enantiomers in invitro studies. The major metabolite, desmethylazelastine, also possesses H1-receptor antagonist activity.
","Seasonal Allergic Rhinitis: The recommended dosage of Azelastine Nasal Spray in adults and adolescent patients 12 years and older with seasonal allergic rhinitis is one or two sprays per nostril twice daily. The recommended dosage of Azelastine Nasal Spray in pediatric patients 5 years to 11 years of age is one spray per nostril twice daily.
Vasomotor Rhinitis: The recommended dosage of Azelastine Nasal Spray in adults and adolescent patients 12 years and older with vasomotor rhinitis is two sprays per nostril twice daily. Administer Azelastine Nasal Spray by the intranasal route only.
Priming: Prime Azelastine Nasal Spray before initial use by releasing 4 sprays or until a fine mist appears. When Azelastine Nasal Spray has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears. Avoid spraying Azelastine Nasal Spray into the eyes.
","How to use the Nasal Spray-
+
+- Shake the bottle gently and remove the dust cover.
+- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
+- Gently blow the nose to clear the nostrils.
+- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
+- Breathe out through your mouth.
+- Repeat the above steps in the same/ other nostril for consecutive doses.
+
+Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-
+
+- Remove the dust cover.
+- Gently pull off the nasal applicator.
+- Wash the applicator and dust cover in warm water.
+- Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
+- Gently push the applicator back on the top of the bottle and re-fix the dust cover.
+
","It is especially important to check before combining Azelastine nasal spray with Alcohol, CNS depressants, Cimetidine & Ketoconazole.
","Contraindicated in patients with a known hypersensitivity to Azelastine or any of its components.
","Headache, dizziness, sneezing, nosebleed, nausea, stinging or itching in nose, dry mouth, sore throat, bitter taste etc.
","Use in pregnancy: The effects of Azelastine during pregnancy have not been adequately studied. Azelastine should be administered during pregnancy, if the potential benefit justifies the potential risks to fetus.
Use in nursing mother: It is not known whether Azelastine is excreted in human milk. However, caution should be exercised when Azelastine is administered to a nursing mother.
","In clinical trials, the occurrence of somnolence has been reported in some patients taking Azelastine nasal spray; due caution should therefore be exercised when driving a car or operating potentially dangerous machinery. Concurrent use of this nasal spray with alcohol or other CNS depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.
","Use in children: The safety and effectiveness of Azelastine nasal spray in patients below 5 years of age have not been established.
",,,,"Keep out of reach of children. Store in a cool and dry place protected from light. Do not freeze.
",12
+1727,Nux-vomica + Black Pepper + Long Pepper,nux-vomica-black-pepper-long-pepper-1727,,Herbal and Nutraceuticals,Rheumatoid arthritis,"This is indicated in-
+
+- Rheumatoid arthritis
+- Osteoarthritis
+- Sexual debility
+- Nervous debility
+- Numbness
+- Sciatica
+- Paralysis & Facial Paralysis
+
","Herbal and Nutraceuticals
","This is a unique unani medicine, prepared with of Nux-vomica (Strychnos nux-vomica), Black Pepper (Piper nigrum), Long Pepper (Piper longum) and other effective natural ingredients. It is very effective in nervous debility, rheumatism, numbness, paralysis, facial paralysis and sexual debility. This is also helps to relieve tremor and sciatica.
","1-2 tablet(s) 1-2 time(s) daily after meal or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in the therapeutic dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1760,Nimbadi Churna,nimbadi-churna-1760,,Herbal and Nutraceuticals,Psoriasis,"This is indicated in skin diseases like Acne vulgaris, Eczema, Psoriasis and Boils.
","Herbal and Nutraceuticals
","
+- Azadirachta indica: It contains nimbin, nimbinene, nimbidin, nimbidinin, azadirone, azadirachtin, p-sitosterol, ascorbic acid, p-hexacosanol and amino acids. The antibacterial, antifungal & blood purifying properties of Neem are useful in skin disorders and keep the skin healthy. It is useful as a tonic and astringent that promotes wound healing. It is beneficial in treating cutaneous diseases such as Acne, Psoriasis and Eczema.
+- Tinospora cordifolia: Its principal constituents are tinosporine, tinosporide, cordifolide, cordifol, columbin and p-sitosterol. It has antiinflammatory, antipyretic, immunomodulator and antioxidant properties. It is useful for removing toxicity from body and improving immune system and the body's resistance against infection.
+- Terminalia chebula: It contains resin, ellagic acid, tannic acid, chebulinic acid and gallic acid. It has antioxidant and antiinflammatory properties. Ellagic acid helps our skin prevent the mutagenic action of some environmental pollutants.
+- Phyllanthus emblica: The principal constituent is vitamin-C. It also contains tannins, glucose, pectin and minerals like iron, phosphorus & calcium. It has antibacterial and antifungal activities.
+- Centratherum anthelminticum: It contains a-gallocatechol, a-pyrocatechol, centratherin and germacranolide. It has anthelmintic activity. It is used in skin diseases.
+- Zingiber officinale: It contains volatile oil, gingerols, shogaols, gingediols and starch. It has antimicrobial, antiinflammatory and antioxidant effects. It has also shown immune system stimulating effect.
+- Embelia ribes: It contains embelin, quercitol, resinoid, tannin & volatile oil. It is astringent & stimulant. It has antibacterial & antiprotozoal properties. It is widely used in skin related ailments due to its cooling effects.
+- Cassia tora: It contains obtusin, anthraquinone glucosides, cassiaside and p-sitosterol. It has antibiotic activity. It cures eczema, dermatosis, itching & all types of skin diseases.
+- Piper longum: It contains 1% essential oil, which exhibits antibacterial activities. It relieves inflammation. Tracbyspermum ammi: It contains an essential oil, protein & fat. It has antibiotic activity.
+- Acorus calamus: It contains volatile oil. It has vermicidal & insecticidal effects. It is used for eczema.
+- Nigella saliva: It contains volatile oil, resin, tannin, saponin, cymene, nigellin, arable acid & carbonic acid. It has been used to treat skin condition such as eczema and boils.
+- Picrorrhiza kurroa: It contains picrorhizin, kutkin, picroside-1, picroside-2, picroside-3, kurrin, kutkiol & glycosides. It has antiinflammatory, antibacterial, tonic & laxative properties. It is used in constipation, dyspepsia, autoimmune disease such as psoriasis and vitiligo.
+- Acacia catechu: It contains catechin, taxifolin and catechutannic acid. Catechin is biologically highly active. It is used as a hemostatic. Taxifolin has antibacterial, antifungal, antiinflammatory and antioxidant properties. It helps in relieving from itching & excessive body temperature. It is used for boils and eruption on the skin. It is also used in dermatological disorders.
+- Curcuma longa: The active constituent is known as curcumin. It has been shown to have a wide range of therapeutic effects. It has strong antioxidant & antiinflammatory properties. It protects the liver from a number of toxic compounds.
+- Berberis aristata: It contains berberine, oxycanthine & berbamine. It has antiinflammatory & antiprotozoal properties.
+- Cyperus rotundus: It contains cyperene-1 and cyperene-2, cyperotundone, p-selinene, cyperenone, a cyperone and essential oil. It has astringent, analgesic, antiinflammatory, antifungal, antiparasitic, anthelmintic and stimulant properties. It is a rich source of minerals like Cu, Mg, Mn & Ni. It is a good skin disorder healer and also helps in early healing of wounds.
+- Cedrus deodara: It contains sesquiterpene, alkaloid & resin. It also contains minerals like calcium and phosphorus. It is a very good pain reliever. It is also beneficial in skin ailments.
+- Saussurea lappa: It contains volatile oil, potassium nitrate, p-sitosterol & essential oil. It has strong antiseptic property. It is used in chronic skin diseases.
+
","2-4 capsules 3 times daily or as prescribed by the physician.
",,,"Not yet known.
","There is no known side effect.
","There is no sufficient information.
",,,,,,"Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.
",8
+1525,Nigella Sativa [Black Seed Oil],nigella-sativa-black-seed-oil-1525,,Herbal and Nutraceuticals,Vomiting,"
+- রােগ প্রতিরােধ ক্ষমতা বাড়াতে, ক্যান্সার প্রতিরােধে এবং এলার্জি চিকিৎসায় কালােজিরা বৈজ্ঞাণিকভাবে প্রমাণিত।
+- শরীরের ক্ষতিকর কোলেস্টেরল (LDL, TG) কমাতে এবং উপকারী কোলেস্টেরল (HDL) বাড়াতে সাহায্য করে।
+- রক্তচাপ নিয়ন্ত্রণে রাখতে সাহায্য করে।
+- বাতজনিত সমস্যা সমাধানে সহায়ক।
+- ডায়াবেটিস রােগীদের রক্তের গ্লুকোজের মাত্রা নিয়ন্ত্রণে সাহায্য করে।
+- থাইরয়েড হরমােনের মাত্রা কমিয়ে এনে হাইপারথাইরয়েডিজম নিয়ন্ত্রণে সহায়ক।
+- শ্বাসকষ্টের রোগীদের কফ, কাশি কমিয়ে ফুসফুসের কার্যকারিতা বৃদ্ধি করতে সাহায্য করে।
+
","Herbal and Nutraceuticals
","কালাে জিরা প্রায় ২০০০ বছরেরও বেশি সময় ধরে ওষুধ হিসাবে ব্যবহৃত হয়ে আসছে। এমনকি কিং টুটের সমাধি থেকেও এটি আবিষ্কৃত হয়েছিল। প্রাচীনকাল থেকেই কালাে জিরা মাথা ব্যথা, দাঁত ব্যথা, নাক বন্ধ এবং পেটের ক্রিমি উপশমে ব্যবহৃত হয়ে আসছে। বর্তমানে কালাে জিরা পরিপাকতন্ত্রের বিভিন্ন সমস্যা, যেমন- গ্যাস্ট্রিক, পেট ব্যথা, ডায়রিয়া, আমাশয়, কোষ্ঠকাঠিন্য এবং অশ্বরােগেও ব্যবহৃত হয়। এছাড়াও এটি হাঁপানি, এলার্জি, ব্রংকাইটিস, এমফিসেমা এবং কনজেশনের মত বিভিন্ন শ্বসনতন্ত্রের সমস্যায় ব্যবহৃত হয়। রক্তচাপ নিয়ন্ত্রণে, চর্বি কমাতে, ক্যান্সার নিরাময়ে এবং রােগ প্রতিরােধ ক্ষমতা বাড়াতেও এর ব্যবহার লক্ষণীয়। মহিলারা মাসিকের সমস্যায় এমনকি দুধের পরিমাণ বাড়াতেও কালােজিরা ব্যবহার করে। কালােজিরা কেমােথেরাপির পার্শ্বপ্রতিক্রিয়া কমাতেও সাহায্য করে। অনেকে বাতের ব্যথা, মাথা ব্যথা এবং ত্বকের নানা সমস্যায় সরাসরি কালােজিরা তেল ব্যবহার করে থাকেন।
","প্রাপ্ত বয়স্ক (১৫ বছরের উপরে): ১ টি করে ক্যাপসুল দিনে ২ বার।
শিশু (৫-১৫ বছরের মধ্যে): প্রতিদিন ১ টি করে ক্যাপসুল অথবা চিকিৎসকের পরামর্শ অনুযায়ী সেব্য।
",,,"৫ বছরের কম বয়সী শিশুদের ক্ষেত্রে ব্যবহার সমীচিন নয়।
","স্বল্পমাত্রায় ওষুধ হিসাবে ব্যবহারে কোন বির���প প্রতিক্রিয়া লক্ষ্য করা না গেলেও, অতিমাত্রায় ব্যবহার কতটুকু নিরাপদ সে বিষয়ে যথেষ্ট তথ্য পাওয়া যায় না।
","গর্ভাবস্থায় এর ব্যবহারে কোন নিষেধাজ্ঞা জানা যাযনি। এটি মাতৃদুগ্ধ উৎপাদন এবং নিঃসরণ বৃদ্ধিতেও বহুল ব্যবহৃত।
","কালােজিরা রক্ত জমাট বাঁধার প্রক্রিয়াকে ব্যহত করে রক্ত ক্ষরণের সম্ভাবনাকে বাড়িয়ে দেয়। তাই এটি ব্লিডিং ডিজঅর্ডারকে আরও বৃদ্ধি করে থাকে। তাছাড়া কালােজিরা অ্যানেস্থেসিয়ার সাথেও সমস্যা সৃষ্টি করে বিধায় এটি যে কোন সার্জারির কমপক্ষে দুই সপ্তাহ আগে থেকে বন্ধ করা উচিৎ।
",,,,,"আলাে থেকে দূরে, শুষ্ক ও ঠাণ্ডা স্থানে রাখুন। সকল ওষুধ শিশুদের নাগালের বাইরে রাখুন।
",9
+1759,Neem,neem-1759,,Herbal and Nutraceuticals,Wounds,"This is indicated in Bacterial & viral skin infections, wound healing, chronic dermatitis, acne vulgaris
","Herbal and Nutraceuticals
","Neem seed oil: Triterpenes & tetranortriterpenes (limonoid and protolimonoids of the gedunin group).
Neem bark: A paraffin alcohol-sugiol, oxyphenol nimbiol, nimbosterol nimbolin A ad nimbolin B.
Neem leave: It’s mainly yield the flavanoid quercetin and nimbosterol as well as a number of limonoids. Quercetin, a polyphenolic flavonoid, is known to have antibacterial and antifungal properties.
Neem is used ayurvedic medicine for skin diseases, leprosy, inflammation, infections, fever, and purification of blood. It is also used antiseptic, astringent, anthelmintic. Neem is mentioned in most Ayurvedic formulations for the treatment of skin disorders, because of its detoxifying properties. The growth of acne- causing bacteria such as propionibacterium acnes (P. acnes) and staphylococcus epidermidis is also inhibited by Neem.
","1-2 tablets, twice daily or as prescribed by the physician.
",,,"There is no absolute contraindication.
","There is no significant side effect associated with the use of Neem in the above mentioned therapeutic doses.
","Not recommended for use during pregnancy. There is no sufficient information for use in lactation.
",,,,,,"Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.
",8
+1693,Natural medicine for diabetes,natural-medicine-for-diabetes-1693,,Herbal and Nutraceuticals,Diabetes mellitus,"This tablet is indicated in diabetes.
","Herbal and Nutraceuticals
","This tablet is a research product of Hamdard Laboratories. It is a proven unani formulation for diabetes. The main ingredient of this tablet is Gymnema (Gymnema sylvestre) is also called gurmar, which is a Hindi name meaning 'destroyer of sugar'. This tablet corrects the functions of pancreas & stimulates insulin secretion. It helps to block the absorption of sugar from gastrointestinal tract and maintains the normal blood sugar level.
","1-2 tablet(s) should be taken 30 minutes before meal twice daily or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Avoid sweet and excess carbohydrate containing foods. Keep out ofreach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1299,Aspirin + Dipyridamole,aspirin-dipyridamole-1299,https://medex.com.bd/attachments/glQRTqFCN5zdTRi1RycN3gb9eBEHR8/aspirin-dipyridamole-prescribing-information,Anti-platelet drugs,Venous thrombosis,"This capsule is a combination antiplatelet agent indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or a complete ischemic stroke due to thrombosis.
","Anti-platelet drugs
","This is a combination of anti-platelet agents Aspirin & Dipyridamole intended for oral administration. Aspirin inhibits platelet aggregation by irreversible inhibition of platelet cyclooxygenase and thus inhibits the generation of thromboxane A2. Dipyridamole inhibits platelet aggregation by inhibiting the uptake of adenosine into platelet, which is a potent mediator of vasodilation. Dipyridamole increases local concentration of adenosine which increases cAMP (cyclic-adenosine monophosphate) level thus decreased ca++ concentration and inhibits platelet aggregation. Dipyridamole also inhibits phosphodiesterase (PDE) especially cyclic-guanosine monophosphate-PDE (cGMP-PDE), which increases cGMP produced by EDRF (endothelium-derived relaxing factor) Nitric oxide a potent vasodilator.
","The recommended dose is one capsule given orally twice daily. One in the morning and one in the evening. Capsules should be swallowed whole without chewing. This can be administered with or without food.
Pediatric Use: The safety and effectiveness of this capsule in pediatric patients have not been studied. So, the use of this preparation in the pediatric population is not recommended.
",,"Co-administration with anticoagulants, antiplatelets or NSAIDS can increase risk of bleeding. Decreased renal function can occur with co-administration with NSAID, beta blockers and diuretics. Dipyridamole may counteract the anticholinesterase effect of cholinesterase inhibitors, thereby potentially aggravating myasthenia gravis.
","Hypersensitivity: This capsule is contraindicated in patients with known hypersensitivity to any of the product components.
Allergy: Aspirin is contraindicated in patients with known allergy to Nonsteroidal anti-inflammatory drugs and in patients with the syndrome of asthma, rhinitis and nasal polyps. Aspirin may cause severe urticaria, angioedema or bronchospasm.
Reye Syndrome: Aspirin should not be used in children or teenagers with viral infections because of the risk of Reye syndrome.
","The most frequently reported adverse reactions are headache, dyspepsia, abdominal pain, nausea and diarrhea.
","Pregnancy Category D. Aspirin can results in excessive blood loss at delivery as well as prolonged gestation and prolonged labor. So this capsule should be avoided in the third trimester of pregnancy and during labor and delivery. Both Dipyridamole and Aspirin are excreted in human milk. This capsule not to be administered to a nursing woman.
","This is not interchangeable with the individual components of Aspirin and Dipyridamole tablets. This increases the risk of Intracranial Hemorrhage & Gastrointestinal Bleeding. Avoid this in patient with peptic ulcer, coronary artery diseases, hypotension & severe renal failure or hepatic insufficiency.
",,"Overdosage of this is likely to be dominated by signs and symptoms of Dipyridamole & Aspirin overdoses. Overdose of Dipyridamole shows hemodynamic effects with various symptoms such as warm feeling, flushes, sweating, restlessness, feeling of weakness, dizziness and a drop in blood pressure and tachycardia might also be observed. The sign of Aspirin overdose includes tinnitus, hyperthermia and hypovolemia. Treatment of overdose consists primarily of supporting vital functions, increasing drug elimination, correcting acid-base disturbances and gastric emptying or lavage as soon as possible after ingestion. Maintain fluid, electrolyte balance and to control the hypoglycemic condition intravenous fluid and infusion of glucose must be administered. Administration of Xanthine derivatives (e.g. aminophylline) may reverse the hemodynamic effects of Dipyridamole overdose.
",,,"Store at cool & dry place. Protect from light. Keep away from reach of children.
",11
+85,Aspirin,aspirin-85,https://medex.com.bd/attachments/jshBNQ3uaGh9bZMVXrqNwEditHlTux/aspirin-prescribing-information-prescribing-information,Anti-platelet drugs,Yellow fever infection,"Aspirin is indicated in the following indications-
+
+- Prophylaxis against arterial occlusive events: Myocardial infarction, myocardial re-infarction, after bypass surgery, acute ischaemic stroke/TIA.
+- Mild to moderate pain: Headache, muscle pain, dysmenorrhoea and toothache etc.
... Read more
Aspirin is indicated in the following indications-
+
+- Prophylaxis against arterial occlusive events: Myocardial infarction, myocardial re-infarction, after bypass surgery, acute ischaemic stroke/TIA.
+- Mild to moderate pain: Headache, muscle pain, dysmenorrhoea and toothache etc.
+- Chronic disease accompanied by pain and inflammation: Osteoarthritis.
+- Antipyretic: Cold fever and influenzae.
+
","Anti-platelet drugs
","By decreasing platelet aggregation, Aspirin inhibits thrombus formation on the arterial side of the circulation, where thrombi are formed by platelet aggregation and anticoagulants have little effect. Aspirin is the analgesic of choice for headache, transient musculoskeletal pain and dysmenorrhoea. It has anti-inflammatory and antipyretic properties, which may be useful. Enteric-coated Aspirin reduces intestinal disturbance and gastrointestinal ulceration due to aspirin.
","Pain, inflammatory diseases and as antipyretic: Aspirin 300 mg 1-3 tablets 6 hourly with a maximum daily dose of 4 gm.
Suspected acute coronary syndrome: 150 mg-300 mg immediately unless there are clear contraindications.
After myocardial infarction: Aspirin 150 mg daily for 1 month. Long-term use of aspirin in a dose of 75 mg daily is recommended thereafter.
Acute ischaemic stroke/Transient ischaemic stroke (TIA): The starting dose is 150 mg-300 mg daily and Aspirin 75 mg daily thereafter.
Following bypass surgery: 75 mg-300 mg daily starting 6 hours post-procedure.
",,"Salicylates may enhance the effect of anticoagulants, oral hypoglycaemic agents, phenytoin and sodium valporate. They inhibit the uricosuric effect of probenecid and may increase the toxicity of sulphonamides. They may also precipitate bronchospasm or induce attacks of asthma in susceptible subjects.
","Aspirin is contraindicated to the children (Reye's syndrome) less than 12 years, in breast-feeding and active peptic ulcer. It is also contraindicated in bleeding due to haemophilia, intracranial haemorrhage and other ulceration.
","Side effects for the usual dosage of Aspirin are mild including nausea, dyspepsia, gastrointestinal ulceration and bronchospasm etc.
","It is especially important not to use aspirin during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Aspirin penetrates into breast milk. So, it should be administered with caution to lactating mothers.
","It should be administered cautiously in asthma, uncontrolled blood pressure, and pregnant women. It should be administered with caution to patients with a nasal polyp and nasal allergy.
",,"Overdosage produces dizziness, tinnitus, sweating, nausea and vomiting, confusion and hyperventilation. Gross overdosage may lead to CNS depression with coma, cardiovascular collapse and respiratory depression. If the overdosage is suspected, the patient should be kept under observation for at least 24 hours, as symptoms and salicylate blood levels may not become apparent for several hours. Treatment of overdosage consists of gastric lavage and forced alkaline diuresis. Haemodialysis may be necessary in severe cases.
",,,"Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.
",11
+164,Calcipotriol Monohydrate,calcipotriol-monohydrate-164,https://medex.com.bd/attachments/sccgeRpsJTDxtHR4y1LanY3OtmP2t5/calcipotriol-monohydrate-prescribing-information,Topical Vitamin D & related preparations,Scalp psoriasis,"Calcipotriol cream & ointment is indicated for the topical treatment of chronic stable plaque type psoriasis vulgaris in adult patients.
","Topical Vitamin D & related preparations
","Calcipotriol is a non-steroidal antipsoriatic agent, derived from vitamin D. Calcipotriol exhibits a vitamin D-like effect by competing for the 1,25(OH)2D3 receptor. Calcipotriol is as potent as 1,25(OH)2D3, the naturally occurring active form of vitamin D, in regulating cell proliferation and cell differentiation, but much less active than 1,25(OH)2D3 in its effect on calcium metabolism. Calcipotriol induces differentiation and suppresses proliferation (without any evidence of a cytotoxic effect) of keratinocytes, thus reversing the abnormal keratinocyte changes in psoriasis. The therapeutic goal envisaged with calcipotriol is thus a normalization of epidermal growth.
","Calcipotriol cream & ointment should be applied topically to the affected area twice daily (i.e. in the morning and in the evening). Less frequent application may be indicated after the initial period of treatment. After satisfactory improvement has occurred, treatment should be discontinued. If recurrence takes place after discontinuation, the treatment may be reinstituted. Experience is lacking in the use of calcipotriol for periods longer than 1 year. The maximum recommended weekly dose of calcipotriol cream is 100 gm/week.
",,,"Calcipotriol cream & ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations. It is also contraindicated in patients with known disorders of calcium metabolism.
","Photosensitivity reactions, skin discolouration, bullous eruption, skin exfoliation, contact dermatitis and allergic reactions have been reported with topical calcipotriol therapy.
","Safety for use in pregnancy has not been established. Therefore calcipotriol should not be used during pregnancy unless benefits clearly outweigh the risks. It is not known whether calcipotriol is excreted in breast milk, therefore, the drug should be used during lactation only if the benefits clearly outweigh the risks. Calcipotriol should not be applied to the chest area during breast feeding to avoid possible ingestion by infants.
","Calcipotriol cream & ointment is not recommended for use in patients with generalized pustular psoriasis, guttate psoriasis and erythrodermic exfoliate psoriasis. Calcipotriol cream & ointment is not recommended for use on the face.
","Calcipotriol cream & ointment should not be used in children, as there is inadequate experience with its use.
",,,,"Store below 25° C, away from light and moisture. Do not freeze. Keep all medicines out of reach of children.
",10
+163,Calamine + Zinc Oxide + Glycerine,calamine-zinc-oxide-glycerine-163,,Local Antipruritic,Urticaria,"This medication is used to relieve pain, itching, and discomfort from minor skin irritations such as poison ivy, poison oak, and poison sumac. It also helps to dry the oozing and weeping caused by irritation due to these plants.
","Local Antipruritic
","Calamine has mild astringent and antipruritic actions. Zinc oxide has astringent, soothing and protective properties and is used in topical preparations for eczema, slight excoriations, wounds and haemorrhoids. It also reflects ultraviolet radiation and can be used as a physical sunscreen.
","Adult: Apply 3-4 times daily for 3-5 days.
","Use this medication on the skin only. Follow all directions on the product package, or use as directed by your doctor. Shake the bottle well before using. Apply the medication with a cotton pad, and allow the medication to dry on the skin. If you are uncertain about any of the information, consult your doctor or pharmacist.
","There are no known drug interactions for calamine/ zinc oxide topical.
","History of hypersensitivity to any of the components.
","A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
","Category Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
","For external use only. Not to be used on open wounds or burns.
","Pediatrics: Appropriate studies on the relationship of age to the effects of calamine have not been performed in the pediatric population.
Geriatrics: Appropriate studies on the relationship of age to the effects of calamine have not been performed in the geriatric population.
",,,,,11
+2035,Caffeine Citrate,caffeine-citrate-2035,https://medex.com.bd/attachments/YbZCTbxNQloL03scmIGlYinsBlqTQQ/caffeine-citrate-prescribing-information,Painkiller Muscle Relaxant,Obstructive sleep apnea (OSA),"Caffeine Citrate is indicated for the treatment of apnea of prematurity.
","Painkiller Muscle Relaxant
","Caffeine is structurally related to other methylxanthines, theophylline and theobromine. It is a bronchial smooth muscle relaxant, a CNS stimulant, a cardiac muscle stimulant and a diuretic. Although the mechanism of action of caffeine in apnea of prematurity is not known, several mechanisms have been hypothesized. These include:
+
+- stimulation of the respiratory center,
+- increased minute ventilation,
+- the decreased threshold to hypercapnia,
+- increased response to hypercapnia,
+- increased skeletal muscle tone,
+- decreased diaphragmatic fatigue,
+- increased metabolic rate,
+- increased oxygen consumption.
+
+Most of these effects have been attributed to antagonism of adenosine receptors, both A1 and A2 subtypes, by caffeine
","Loading Dose: Dose of Caffeine Citrate-20 mg (1 ml) /kg-Route-Intravenous infusion (over 30 minutes) by using a syringe infusion pump-Frequency-One Time
Maintenance Dose: Dose of Caffeine Citrate-5 mg (0.25 ml) /kg-Route-Intravenous infusion (over 10 minutes) by using a syringe infusion pump-Frequency-Every 24 hours (beginning 24 hours after the loading dose)
The duration of treatment of apnea of prematurity in the clinical trial was limited to 10 to 12 days. The safety and efficacy of caffeine citrate for longer periods of treatment have not been established. Vials containing visible particulate matter should be discarded. For single use only. Any unused solution should be discarded.
",,"Few data exist on drug interactions with caffeine in preterm neonates. Based on adult data, lower doses of caffeine may be needed following co-administration of drugs which are reported to decrease caffeine elimination (e.g., cimetidine and ketoconazole) and higher caffeine doses may be needed following co-administration of drugs that increase caffeine elimination (e.g., phenobarbital and phenytoin). Inter-conversion between caffeine and theophylline has been reported in preterm neonates. The concurrent use of these drugs is not recommended.
",,"Few cases of sepsis, hemorrhage, necrotizing enterocolitis, gastritis, gastrointestinal hemorrhage, acidosis, cerebral hemorrhage, dyspnea, lung edema, dry skin, rash, skin breakdown, kidney failure were reported.
","Pregnancy Category C. Caffeine is excreted into breast milk. Breast-feeding mothers of newborn infants treated with Caffeine Citrate should not ingest caffeine-containing foods, beverages or medicinal products containing caffeine.
","Caffeine Citrate should be used with caution in infants with seizure disorders, cardiovascular disease and impaired renal or hepatic function. Serum concentrations of caffeine should be monitored and dose administration of Caffeine Citrate should be adjusted to avoid toxicity in this population.
",,"Serious toxicity has been associated with serum levels greater than 50 mg/L. Signs and symptoms reported after caffeine overdose in preterm infants include fever, tachypnea, insomnia, tremor, hypertonia, seizures, vomiting, hyperglycemia, elevated blood urea nitrogen and elevated total leukocyte concentration. Caffeine levels have been shown to decrease after exchange transfusions. Convulsions may be treated with intravenous administration of diazepam or a barbiturate such as pentobarbital sodium.
",,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",10
+1487,Cabozantinib,cabozantinib-1487,https://medex.com.bd/attachments/7UMvfCgFuUFXUf0Hn2ZKi8Egn90qn1/cabozantinib-prescribing-information,Tyrosine Kinase Inhibitor,Renal cell carcinoma,"Renal Cell Carcinoma: Cabozantinib is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).
Hepatocellular Carcinoma: Cabozantinib is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with Sorafenib.
","Tyrosine Kinase Inhibitor
","In vitro biochemical and/or cellular assays have shown that Cabozantinib inhibits the tyrosine kinase activity of MET, VEGFR-1, -2 and -3, AXL, RET, ROS1, TYRO3, MER, KIT, TRKB, FLT-3, and TIE-2. These receptor tyrosine kinases are involved in both normal cellular function and pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, drug resistance, and maintenance of the tumor microenvironment.
Absorption: Median time to peak cabozantinib concentrations (Tmax) ranged from 3 to 4 hours post-dose. A 19% increase in the Cmax of Cabozantinib compared to a Cabozantinib capsule formulation was observed following a single 140 mg dose. A less than 10% difference in the AUC was observed between Cabozantinib and a Cabozantinib capsule formulation.
Distribution: The oral volume of distribution (Vz/F) of Cabozantinib is approximately 319 L. Cabozantinib is highly protein-bound in human plasma (≥99.7%).
Elimination: The predicted terminal half-life is approximately 99 hours and the clearance (CL/F) at steady state is estimated to be 2.2 L/hr.
Metabolism: Cabozantinib is a substrate of CYP3A4 in vitro.
Excretion: Approximately 81% of the total administered radioactivity was recovered within a 48-day collection period following a single dose of radiolabeled 14 C- Cabozantinib in healthy subjects. Approximately 54% was recovered in feces and 27% in urine. Unchanged Cabozantinib accounted for 43% of the total radioactivity in feces and was not detectable in urine following a 72-hour collection.
","Recommended Dosage for Renal Cell Carcinoma: The recommended dosage of Cabozantinib is 60 mg once daily without food until the patient no longer experiences clinical benefit or experiences unacceptable toxicity.
Recommended Dosage for Hepatocellular Carcinoma: The recommended dosage of Cabozantinib is 60 mg once daily without food until disease progression or unacceptable toxicity. Or, as directed by the registered physicians.
+
+- Stop treatment with Cabozantinib at least 28 days prior to scheduled surgery, including dental surgery.
+- Do not substitute Cabozantinib tablets with Cabozantinib capsules.
+- Do not administer Cabozantinib with food. Administer at least 1 hour before or at least 2 hours after eating.
+- Swallow Cabozantinib tablets whole. Do not crush Cabozantinib tablets.
+- Do not take a missed dose within 12 hours of the next dose.
+- Modify the dose for certain patients with hepatic impairment and for patients taking drugs known to strongly induce or inhibit CYP450.
+
+
Pediatric Use: The safety and effectiveness of Cabozantinib in pediatric patients have not been established.
",,"Strong CYP3A4 Inhibitors: Coadministration of a Cabozantinib capsule formulation with a strong CYP3A4 inhibitor increased the exposure of Cabozantinib, which may increase the risk of exposure-related adverse reactions. Avoid coadministration of Cabozantinib with strong CYP3A4 inhibitors. Reduce the dosage of Cabozantinib if coadministration with strong CYP3A4 inhibitors cannot be avoided. Avoid grapefruit or grapefruit juice which may also increase exposure of Cabozantinib.
Strong CYP3A Inducers: Coadministration of a Cabozantinib capsule formulation with a strong CYP3A4 inducer decreased the exposure of Cabozantinib, which may reduce efficacy. Avoid coadministration of Cabozantinib with strong CYP3A4 inducers. Increase the dosage of Cabozantinib if coadministration with strong CYP3A4 inducers cannot be avoided. Avoid St. John's Wort which may also decrease exposure of Cabozantinib.
","It is contraindicated in patients with known hypersensitivity to Cabozantinib or any other components of this product.
","
+- Hemorrhage
+- Perforations and Fistulas
+- Thrombotic Events
+- Hypertension and Hypertensive Crisis
+- Diarrhea
+- Palmar-plantar Erythrodysesthesia
+- Proteinuria
+- Osteonecrosis of the Jaw
+- Wound Complications
+- Reversible Posterior Leukoencephalopathy Syndrome
+
","Pregnancy: Cabozantinib can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk.
Lactation: There is no information regarding the presence of Cabozantinib or its metabolites in human milk, or their effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in breastfed children, women should be advised not to breastfeed during treatment with Cabozantinib and for 4 months after the final dose.
Contraception: Cabozantinib can cause fetal harm when administered to a pregnant woman.
Females: Females of reproductive potential should be advised to use effective contraception during treatment with Cabozantinib and for 4 months after the final dose.
Infertility: Females and Males: Based on findings in animals, Cabozantinib may impair fertility in females and males of reproductive potential.
","Hemorrhage: Severe and fatal hemorrhages occurred with Cabozantinib. Discontinue Cabozantinib for Grade 3 or 4 hemorrhage. Do not administer Cabozantinib to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.
Perforations and Fistulas: Fistulas, including fatal cases, occurred in 1% of Cabozantinib-treated patients. Gastrointestinal (GI) perforations, including fatal cases, occurred in 1% of Cabozantinib-treated patients. Monitor patients for signs and symptoms of fistulas and perforations, including abscess and sepsis. Discontinue Cabozantinib in patients who experience a fistula that cannot be appropriately managed or a GI perforation.
Thrombotic Events: Cabozantinib increased the risk of thrombotic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism occurred in 2% of Cabozantinib
-treated patients. Fatal thrombotic events occurred in Cabozantinib-treated patients. Discontinue Cabozantinib in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic events that require medical intervention.
Hypertension and Hypertensive Crisis: Cabozantinib can cause hypertension, including hypertensive crisis. Do not initiate Cabozantinib in patients with uncontrolled hypertension. Monitor blood pressure regularly during Cabozantinib treatment. Withhold Cabozantinib for hypertension that is not adequately controlled with medical management; when controlled, resume Cabozantinib at a reduced dose. Discontinue Cabozantinib for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.
Diarrhea: Diarrhea occurred in 63% of patients treated with Cabozantinib. Withhold Cabozantinib until improvement to Grade 1 and resume Cabozantinib at a reduced dose for intolerable Grade 2 diarrhea, Grade 3 diarrhea that cannot be managed with standard antidiarrheal treatments, or Grade 4 diarrhea.
Palmar-Plantar Erythrodysesthesia: Palmar-plantar erythrodysesthesia (PPE) occurred in 44% of patients treated with Cabozantinib. Withhold Cabozantinib until improvement to Grade 1 and resume Cabozantinib at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE.
Proteinuria: Proteinuria was observed in 7% of patients receiving Cabozantinib. Monitor urine protein regularly during Cabozantinib treatment. Discontinue Cabozantinib in patients who develop nephrotic syndrome.
Osteonecrosis of the Jaw: Osteonecrosis of the jaw (ONJ) occurred in <1% of patients treated with Cabozantinib. ONJ can manifest as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration or erosion, persistent jaw pain or slow healing of the mouth or jaw after dental surgery. Perform an oral examination prior to initiation of Cabozantinib and periodically during Cabozantinib. Advise patients regarding good oral hygiene practices. Withhold Cabozantinib for at least 28 days prior to scheduled dental surgery or invasive dental procedures, if possible. Withhold Cabozantinib for development of ONJ until complete resolution.
Wound Complications: Wound complications have been reported with Cabozantinib. Stop Cabozantinib at least 28 days prior to scheduled surgery. Resume Cabozantinib after surgery based on clinical judgment of adequate wound healing. Withhold Cabozantinib in patients with dehiscence or wound healing complications requiring medical intervention.
Reversible Posterior Leukoencephalopathy Syndrome: Reversible Posterior Leukoencephalopathy Syndrome (RPLS), a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, can occur with Cabozantinib. Perform an evaluation for RPLS in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function. Discontinue Cabozantinib in patients who develop RPLS.
Embryo-Fetal Toxicity: Based on data from animal studies and its mechanism of action, Cabozantinib can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Cabozantinib and for 4 months after the last dose.
",,"One case of overdosage was reported following administration of another formulation of cabozantinib; a patient inadvertently took twice the intended dose for 9 days. The patient suffered Grade 3 memory impairment, Grade 3 mental status changes, Grade 3 cognitive disturbance, Grade 2 weight loss, and Grade 1 increase in BUN. The extent of recovery was not documented.
",,,"Store below 30°C in a cool and dry place, away from sunlight. Keep out of reach of children.
",11
+1434,Cabergoline,cabergoline-1434,https://medex.com.bd/attachments/yPQffe7ElEuksTMJfdA0RHCSRjTpuW/cabergoline-prescribing-information,Antiparkinson drugs,Hyperprolactinemia,"It is indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas. It is used to stop breast milk production (lactation) soon after childbirth, stillbirth, abortion or miscarriage. It can also be used to treat other conditions caused by hormonal disturbance ... Read more
It is indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas. It is used to stop breast milk production (lactation) soon after childbirth, stillbirth, abortion or miscarriage. It can also be used to treat other conditions caused by hormonal disturbance which can result in high levels of prolactin being produced. This includes high levels of prolactin caused by tumours of the pituitary gland in both men and women.
","Antiparkinson drugs
","Cabergoline is a long-acting dopamine receptor agonist with a high affinity for D2 receptors. It works by reducing the amount of prolactin that is released from pituitary gland. Results of in vitro studies demonstrate that Cabergoline exerts a direct inhibitory effect on the secretion of prolactin.
","The recommended dosage of Cabergoline Tablet for initiation of therapy is 0.25 mg twice a week. Dosage may be increased by 0.25 mg twice weekly up to a dosage of 1 mg twice a week according to the patient’s serum prolactin level. Before initiating treatment, cardiovascular evaluation should be performed and echocardiography should be considered to assess for valvular disease.
Dosage increases should not occur more rapidly than every 4 weeks. If the patient does not respond adequately, and no additional benefit is observed with higher doses, the lowest dose that achieved maximal response should be used and other therapeutic approaches considered. Patients receiving long term treatment with Cabergoline should undergo periodic assessment of their cardiac status and echocardiography should be considered.
After a normal serum prolactin level has been maintained for 6 months, Cabergoline may be discontinued, with periodic monitoring of the serum prolactin level to determine whether or when treatment with Cabergoline should be reinstituted.
To prevent milk production (lactation): 1 mg (two 0.5 mg tablets) on the first day after delivery.
To stop lactation once after start of breastfeeding: 0.25 mg (one half of Cabergoline 0.5 mg table) every 12 hours for two days. To reduce prolactin levels in other conditions: Initially, 0.25 mg twice a week. Dose may be increased up to maximum dose of 4.5 mg or until have responded fully to treatment.
",,"Cabergoline should not be administered concurrently with D2-antagonists, such as Phenothiazines, Butyrophenones, Thioxanthenes, or Metoclopramide, Chlorpromazine, Domperidone, and medicines to lower blood pressure.
","Cabergoline tablet is contraindicated in patients with:
+
+- Uncontrolled hypertension or known hypersensitivity
+- History of cardiac valvular disorders demonstration of valve leaflet thickening
+- High blood pressure in pregnancy associated with swelling and protein in urine
+- History of pulmonary, pericardial, or retroperitoneal fibrotic disorders & serious mental disease.
+
","Pathological gambling, increased libido, and hypersexuality have been reported in patients treated with dopamine agonists including cabergoline. This has been generally reversible upon reduction of the dose or treatment discontinuation.
","Pregnancy category B. It is not known whether this drug is excreted in human milk.
","Initial doses higher than 1.0 mg may produce orthostatic hypotension. Care should be exercised when administering Cabergoline with other medications known to lower blood pressure, hypersensitivity, severe liver disease & mental illness.
","Pediatric Use: Safety and effectiveness of Cabergoline in pediatric patients have not been established.
Geriatric Use: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Use in patients with hepatic impairment: Since cabergoline is extensively metabolized by the liver, caution should be used, and careful monitoring exercised, when administering Cabergoline to patients with hepatic impairment.
","Over dosage might be expected to produce nasal congestion, syncope, or hallucinations. Measures to support blood pressure should be taken if necessary.
",,,"Store below 25° C. Keep away from light, moisture & out of reach of children.
",12
+1286,Cabazitaxel,cabazitaxel-1286,https://medex.com.bd/attachments/B1bDTb10RiPh8VzzKdlCFintZButKb/cabazitaxel-prescribing-information,Cytotoxic Chemotherapy,Prostate carcinoma,"In combination with prednisone or prednisolone, for patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. Due to high incidence of neutropenia, granulocyte-colony stimulating factor (G-CSF) should be administered within 24-72 hr since 1st cycle of Cabazitaxel administration.
","Cytotoxic Chemotherapy
","Cabazitaxel is a microtubule inhibitor. Cabazitaxel binds to tubulin and promotes its assembly into microtubules while simultaneously inhibiting disassembly. This leads to the stabilization of microtubules, which results in the interference of mitotic and interphase cellular functions. The cell is then unable to progress further into the cell cycle, being stalled at metaphase, thus triggering apoptosis of the cancer cell.
","25 mg/m2 administered as a 1 hr IV infusion every 3 wk in combination with oral prednisone or prednisolone 10 mg administered daily throughout treatment.
",,"May increase plasma conc with strong CYP3A4 inhibitors. May lead to decreased plasma conc with strong CYP3A4 inducers. Vaccination with a live attenuated vaccine should be avoided.
","Neutrophil counts <1,500/mm3; platelets >100,000/mm3, haemoglobin >10 g/dL, creatinine <1.5 x ULN, hepatic impairment (bilirubin ≥1 x ULN, or AST &/or ALT ≥1.5 × ULN); concomitant vaccination with yellow fever vaccine.
","Most commonly in all grades, anemia, leukopenia, neutropenia, thrombocytopenia, diarrhea. Most commonly in ≥3 grade, neutropenia, leukopenia, anemia, febrile neutropenia, diarrhea.
","Pregnancy category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Hypersensitivity reaction; risk of neutropenia; risk of nausea, vomiting, diarrhea, dehydration, peripheral neuropathy; renal failure, cardiac arrhythmias; liver impairment; anemia. Pregnancy & lactation. Elderly.
","Children: The safety and the efficacy of Cabazitaxel in children have not been established.
Elderly: No specific dose adjustment for the use of Cabazitaxel in elderly patients is recommended (see Pharmacology: Pharmacokinetics under Actions, Precautions and Adverse Reactions).
Hepatic Impairment: Cabazitaxel is extensively metabolized by the liver. Patients with mild hepatic impairment [total bilirubin >1 to ≤1.5 x Upper Limit of Normal (ULN) or AST >1.5 x ULN], should have cabazitaxel dose reduced to 20 mg/m2. Administration of cabazitaxel to patients with mild hepatic impairment should be undertaken with caution and close monitoring of safety. Limited efficacy data for cabazitaxel at 15 mg/m2, the maximum tolerated dose in patients with moderate hepatic impairment (total bilirubin >1.5 to ≤3.0 x ULN), are available to recommend this dose in this population. Cabazitaxel should not be given to patients with severe hepatic impairment (total bilirubin >3 x ULN).
Renal Impairment: Cabazitaxel is minimally excreted through the kidney. No dose adjustment is necessary in patients with renal impairment not requiring hemodialysis. Patients presenting end-stage renal disease (CLCR <15 mL/min/1.73 m2), by their condition and the limited amount of available data, therefore these patients should be treated with caution and monitored carefully during treatment.
Concomitant Drug Use: Concomitant drugs that are strong CYP3A inducers or strong CYP3A inhibitors should be avoided (see Pharmacology: Pharmacokinetics under Actions and Interactions). However, if patients require co-administration of a strong CYP3A inhibitor, a 25% cabazitaxel dose reduction should be considered (see Pharmacology: Pharmacokinetics under Actions and Interactions).
",,,,"Store between 15-30° C. Do not refrigerate.
",11
+1397,Butoconazole Nitrate,butoconazole-nitrate-1397,https://medex.com.bd/attachments/BELMxpBroehisiZ7zGuZmD8PqMOWXx/butoconazole-nitrate-prescribing-information,Drugs used in Vaginal and Vulval condition,Vulvovaginal candidiasis,"Butoconazole vaginal cream is indicated for the local treatment of vulvovaginal candidiasis (infections caused by Candida). The diagnosis should be confirmed by KOH smears and/or cultures. Butoconazole vaginal cream is safe and effective in non-pregnant women; however, the safety and effectiveness of this product in pregnant women has not been established.
","Drugs used in Vaginal and Vulval condition
","The exact mechanism of the antifungal action of butoconazole is unknown, however, it is presumed to function as other imidazole derivatives via inhibition of steroid synthesis. Imidazoles generally inhibit the conversion of lanosterol to ergosterol via the inhibition of the enzyme cytochrome P450 14α-demethylase, resulting in a change in fungal cell membrane lipid composition. This structural change alters cell permeability and, ultimately, results in the osmotic disruption or growth inhibition of the fungal cell.
","The recommended dose of Butoconazole is one applicatorful of cream (approximately 5 grams of the cream) intravaginally. This amount of cream contains approximately 100 mg of butoconazole nitrate.
",,,"Butoconazole is contraindicated in patients with a history of hypersensitivity to any of the components of the product.
","Of the 314 patients treated with Butoconazole for 1 day in controlled clinical trials, 18 patients (5.7%) reported complaints such as vulvar/vaginal burning, itching, soreness and swelling, pelvic or abdominal pain or cramping, or a combination of two or more of these symptoms. In 3 patients (1%) these complaints were considered treatment-related. Five of the 18 patients reporting adverse events discontinued the study because of them.
","Pregnancy Category C. In pregnant rats administered 6 mg/kg/day of butoconazole nitrate intravaginally during the period of organogenesis, there was an increase in resorption rate and decrease in litter size; however, no teratogenicity was noted. This dose represents a 130- to 353-fold margin of safety based on serum levels achieved in rats following intravaginal administration compared to the serum levels achieved in humans following intravaginal administration of the recommended therapeutic dose of butoconazole nitrate.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when butoconazole nitrate is administered to a nursing woman
","If clinical symptoms persist, tests should be repeated to rule out pathogens, to confirm the original diagnosis, and to rule out other conditions that may predispose a patient to recurrent vaginal fungal infections.
","Pediatric Use: Safety and effectiveness in children have not been established
",,,,"Store at 25°C
",10
+159,Butenafine Hydrochloride,butenafine-hydrochloride-159,https://medex.com.bd/attachments/lEU1taGPANXYeXoQCfEy0GFCH7vdXg/butenafine-hydrochloride-prescribing-information,Topical Antifungal preparations,Tinea (pityriasis) versicolor,"Butenafine cream is indicated for the topical treatment of the following superficial dermatophytosis: Interdigital tinea pedis (athlete's foot); Tinea corporis (ringworm); Tinea cruris (jock itch) due to E. floccosum, T. mentagrophytes, T. rubrum, and T. tonsurans.
","Topical Antifungal preparations
","Butenafine is a synthetic antifungal agent that is structurally and pharmacologically related to allylamine antifungals. The exact mechanism of action has not been established, but it is suggested that butenafine's antifungal activity is exerted through the alteration of cellular membranes, which results in increased membrane permeability, and growth inhibition.
Butenafine is mainly active against dermatophytes and has superior fungicidal activity against this group of fungi when compared to that of terbinafine, naftifine, tolnaftate, clotrimazole, and bifonazole. It is also active against Candida albicans and this activity is superior to that of terbinafine and naftifine. Butenafine also generates low MICs for Cryptococcus neoformans and Aspergillus spp. as well.
","In the treatment of interdigital tinea pedis, Butenafine should be applied twice daily for 7 days or once daily for 4 weeks. Patients with tinea corporis or tinea cruris should apply Butenafine once daily for two weeks. Sufficient Butenafine cream should be applied to cover affected areas and immediately surrounding skin of patients with interdigital tinea pedis, tinea corporis and tinea cruris.
",,"Potential drug interactions between butenafine HCl cream and other drugs have not been evaluated.
","Butenafine Hydrochloride is contraindicated in individuals who have known or suspected sensitivity to this cream or any of its components.
","Rarely local mild burning or irritation may be experienced. Hypersensitivity reactions may occur.
","Pregnancy Category C. As no adequate and well-controlled studies have been conducted, this drug should be used during pregnancy only if clearly needed. It is not known if butenafine HCl is excreted in human milk. Caution should be exercised in prescribing butenafine HCl to a nursing woman.
","Butenafine cream is not for ophthalmic, oral, or intravaginal use. This is for external use only. If irritation or sensitivity develops with the use of Butenafine cream, treatment should be discontinued and appropriate therapy instituted.
","Safety and efficacy in pediatric patients below the age of 12 years have not been studied.
","Overdosage of butenafine HCl in humans has not been reported to date.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+158,Butamirate Citrate,butamirate-citrate-158,,Cough suppressant,Whooping cough,"Butamirate Citrate is used to relieve dry (non-productive) cough. Dry cough may be caused by a recent viral infection. Butamirate Citrate is also used for pre & post-operative cough sedation in patients who will undergo surgical procedures and bronchoscopy. It can be used in the acute cough of any ... Read more
Butamirate Citrate is used to relieve dry (non-productive) cough. Dry cough may be caused by a recent viral infection. Butamirate Citrate is also used for pre & post-operative cough sedation in patients who will undergo surgical procedures and bronchoscopy. It can be used in the acute cough of any etiology, whooping cough and cough due to acute lower respiratory tract infections (tracheitis, laryngitis, bronchitis) etc.
","Cough suppressant
","Butamirate Citrate acts directly on the brain's cough center to suppress cough. Butamirate Citrate is safe and non-sedating which is neither chemically nor pharmacologically related to opium alkaloids. Butamirate Citrate is rapidly and completely absorbed after oral administration. Maximum concentration is reached within 9 hours with the sustained-release tablet. This is extremely protein-bound and plasma elimination half-life is about 13 hours. The active metabolites of Butamirate Citrate have also antitussive action.
","Use in adult:
+
+- Butamirate Citrate 50 mg tablet: 2-3 tablets daily.
+- Butamirate Citrate syrup: 15 ml 4 times daily.
+
+
Use in children & adolescents:
Butamirate Citrate 50 mg tablet:
+
+- Adolescent over 12 years old: 1-2 tablets daily.
+
+Butamirate Citrate syrup:
+
+- Children (3-6 yrs): 5 ml 3 times daily.
+- Children (6-12 yrs): 10 ml 3 times daily.
+- Adolescent: 15 ml 3 times daily.
+
+Butamirate Citrate pediatric drops:
+
+- Children ( 2 months- 1 yrs): 0.50 ml 4 times daily.
+- Children (1-3 yrs): 0.75 ml 4 times daily.
+
",,"Concomitant use with expectorants should be avoided.
","Hypersensitivity to the active ingredient.
","Tolerance of Butamirate Citrate is good.Adverse reactions such as rash,nausea,diarrhoea and vertigo have been observed in a few rare cases,resolving after dose reduction or treatment withdrawal.
","Butamirate Citrate should not be used during the first trimester of pregnancy. During the remainder of pregnancy, it can be used if indicated by a physician but with caution. As a general rule, for safety reasons, in the absence of data on elimination of the active substance in breast milk, the benefits of Butamirate Citrate administration during breast feeding should be carefully weighed against the risks.
","Butamirate Citrate suppresses the cough reflex and therefore the concomitant use with expectorants should be avoided, since it may lead to mucus retention in the airways, which increases the risk of bronchospasm and respiratory infections. If the cough persists for more than 7 days (more than 3 days in children younger than12 years of age) doctor must be consulted.
",,"Accidental overdose with Butamirate Citrate can cause the following symptoms: drowsiness, nausea, vomiting, diarrhoea, loss of balance and hypotension. Standard emergency procedures should be followed: activated charcoal, saline laxatives and standard cardio-respiratory resuscitation.
",,,"Keep away from light and moisture, store below 30°C. Keep all the medicines out of the reach of children.
",11
+157,Busulfan,busulfan-157,https://medex.com.bd/attachments/6rJIMUZ6Cw14FmkSJGIahz3CcToiWM/busulfan-prescribing-information,Cytotoxic Chemotherapy,Polycythaemia vera,"Busulfan is indicated for Chronic myeloid leukaemia, Polycythemia vera, Essential thrombocythemia, Conditioning regimens for bone marrow transplantation, Conditioning regimens for bone marrow transplantation
","Cytotoxic Chemotherapy
","Busulfan is an alkylating agent that contains 2 labile methanesulfonate groups attached to opposite ends of a 4-carbon alkyl chain. Once busulfan is hydrolyzed, the methanesulfonate groups are released and carbonium ions are produced. These carbonium ions alkylate DNA, which results in the interference of DNA replication and RNA transcription, ultimately leading to the disruption of nucleic acid function. Specifically, its mechanism of action through alkylation produces guanine-adenine intrastrand crosslinks. This occurs through an SN2 reaction in which the relatively nucleophilic guanine N7 attacks the carbon adjacent to the mesylate leaving group. This kind of damage cannot be repaired by cellular machinery and thus the cell undergoes apoptosis.
","Polycythemia vera:
+
+- Adult: 4-6 mg daily continued for 4-6 wk with blood count monitoring, particularly platelet. Further courses may be given if relapse occurs; alternatively, a maintenance therapy approx half the induction dose may be given.
+
+
Chronic myeloid leukaemia:
+
+- Adult: Remission induction: Initially, 0.06 mg/kg daily. Max: 4 mg daily. May increase dose if response is inadequate after 3 wk. Continue until WBC count falls to 15,000-25,000 cells/mm3 (usually 12-20 wk); may stop earlier if platelet count is <100,000 cells/mm3. Maintenance: If WBC count rises to 50,000 cells/mm3 or symptoms return: Resume induction dose; if remission is <3 mth: 0.5-2 mg daily, given as continuous maintenance.
+- Child: Same as adult dose.
+
+
Essential thrombocythemia:
+
",,"Additive myelosuppression with other myelosuppressive agents. Cytotoxic agents may increase risk of pulmonary toxicity. May reduce response to vaccines, possibility of generalised infections with live vaccines. Increased risk of adverse effects if given in conjunction with or soon after radiotherapy. Decreased clearance when used wit cyclophosphamide, itraconazole or paracetamol. Combination with thioguanine may result in oesophageal varices, hepatotoxicity and portal HTN. Increased clearance by phenytoin.
","Patient with chronic myelogenous leukemia whose disease was resistant to prior therapy with the drug; definitive diagnosis of chronic myelogenous leukemia has not firmly established.
","Bone marrow depression, manifested as leucopenia, thrombocytopenia and anaemia; hyperpigmentation, GI disturbances, impaired fertility and gonadal function. Rarely, dry skin, gynaecomastia, cataract formation, at high doses, CNS effects including convulsions.
","Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk
","Discontinue if lung toxicity develops. Severe hepatic or renal impairment. Pregnancy and lactation.
",,"Symptoms: Myelosuppression, bone marrow depression, pancytopenia.
Management: Supportive treatment. Consider haemodialysis.
",,,"Tab: Store below 25°C.
Inj concentrate: Store between 2-8°C.
Do not freeze.
",11
+155,Bupropion Hydrochloride,bupropion-hydrochloride-155,https://medex.com.bd/attachments/jjM1dXVtFfEJ4Mrj85ZRRCtEHdgkxA/bupropion-hydrochloride-prescribing-information,Atypical anti-depressant drugs,Smoking cessation,"Bupropion Hydrochloride is indicated in the treatment of depression. Bupropion is also indicated in smoking cessation.
","Atypical anti-depressant drugs
","Bupropion is a selective inhibitor of the neuronal re-uptake of catecholamines (noradrenaline and dopamine) with minimal effect on the re-uptake of indolamines (serotonin) and does not inhibit monoamine oxidase. While the mechanism of action of bupropion, as with other antidepressants is unknown, it is presumed that this action is mediated by noradrenergic and/or dopaminergic mechanisms.
","The usual adult target dose for Bupropion is 300 mg/day, given as 150 mg, twice daily. Dosing should begin at 150 mg/day given as a single daily dose in the morning. If the 150 mg initial dose is adequately tolerated, an increase to the 300 mg/day target dose, given as 150 mg twice daily, may be made as early as day 4 of dosing. There should be an interval of at least 8 hours between successive doses.
Increasing the dosage above 300 mg/day: As with other antidepressants, the full antidepressant effect of Bupropion Hydrochloride may not be evident until 4 weeks of treatment or longer. An increase in dosage to the maximum of 400 mg/day, given as 200 mg twice daily, may be considered for patients in whom no clinical improvement is noted after several weeks of treatment at 300 mg/day. Bupropion Hydrochloride should be discontinued in patients who do not demonstrate an adequate response after an appropriate period of treatment at 450 mg/day.
Maintenance: The lowest dose that maintains remission is recommended. Although it is not known how long the patient should remain on Bupropion Hydrochloride, it is generally recognised that acute episodes of depression require several months or longer of antidepressant drug treatment.
Child and adolescent: Not recommended for child and adolescent under 18 years of age.
",,"Bupropion should not be given concurrently with or within 14 days of stopping an MAOI. The use of alcohol should be minimised or avoided completely because it may alter the seizure threshold. Similarly, other drugs that lower the seizure threshold, such as other antidepressants, antimalarials, antipsychotics, sedating antihistamines, Quinolones, Tramadol, Theophylline, or systemic corticosteroids, should be used with extreme caution together with Bupropion. Carbamazepine, Phenobarbital, or Phenytoin may induce the metabolism of Bupropion while other drugs such as Cimetidine or Ritonavir may inhibit its metabolism. Interaction may occur between Bupropion and Orphenadrine, Cyclophosphamide, and Ifosfamide. Caution should be exercised when it is given with drugs such as some antidepressants, antipsychotics, β blockers, and type 1C antiarrhythmics.
","It is contraindicated in patients with a seizure disorder. Bupropion Hydrochloride is contraindicated in patients treated with other medications that contain Bupropion because the incidence of seizure is dose dependent. Bupropion may induce seizure and consequently its use is contraindicated in patients with epilepsy. The drug is also contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa because of a higher incidence of seizures noted in such patients treated for bulimia with Bupropion Hydrochloride. The concurrent administration of Bupropion Hydrochloride and a monoamine oxidase (MAO) inhibitor is contraindicated. At least 14 days should elapse between discontinuation of MAO inhibitor and initiation of treatment with Bupropion Hydrochloride. Bupropion Hydrochloride is contraindicated in patients who have shown an allergic response to Bupropion or the other ingredients that make up Bupropion Hydrochloride.
","Agitation, anxiety, and insomnia often occur during the initial stages of Bupropion therapy. Other relatively common side effects reported with Bupropion include fever, dry mouth, headache or migraine, dizziness, nausea and vomiting, constipation, tremor, sweating, and skin rashes. Hypersensitivity reactions, ranging from pruritus and urticaria, less commonly, angio-oedema, dyspnoea, and anaphylactoid reactions have been reported.
","Pregnancy Category C. There are no adequate and well controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Bupropion and its metabolites are secreted in human milk. Because Bupropion is excreted in human milk, a decision should be made whether to discontinue breast feeding or to discontinue the drug.
","It should be used with extreme caution, in patients with history of seizure disorders or in patients with other predisposing factors such as severe hepatic cirrhosis or a CNS tumour, and in those undergoing abrupt withdrawal from alcohol or Benzodiazepines. The use of Bupropion in patients with other risk factors for seizures (for example, alcohol abuse, a history of head trauma, diabetes, and drugs known to lower the seizure threshold) should only be undertaken when there are compelling clinical reasons. Bupropion should be used with caution in patients with bipolar depression or psychoses and in patients with a recent history of myocardial infarction or unstable heart disease and in hepatic or renal impairment.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+153,Bupivacaine Hydrochloride + Dextrose,bupivacaine-hydrochloride-dextrose-153,https://medex.com.bd/attachments/E9YeS9JDIToOXvoI34cRnumWkROhrK/bupivacaine-hydrochloride-dextrose-prescribing-information,Regional anesthesia,Subarachnoid anesthesia,"Bupivacaine Hydrochloride & Dextrose is indicated for-
+
+- Bupivacaine is indicated for lower abdominal surgery (including Caesarean section), urological and lower limb, including hip surgery, lasting 1.5 to 3 hours.
+- Bupivacaine are indicated for intrathecal (subarachnoid, spinal) anesthesia for surgical and obstetrical procedures.
... Read more
Bupivacaine Hydrochloride & Dextrose is indicated for-
+
+- Bupivacaine is indicated for lower abdominal surgery (including Caesarean section), urological and lower limb, including hip surgery, lasting 1.5 to 3 hours.
+- Bupivacaine are indicated for intrathecal (subarachnoid, spinal) anesthesia for surgical and obstetrical procedures.
+- Bupivacaine produces motor blockade of the abdominal muscles makes the solution suitable for performance of abdominal surgery lasting 1.5-2 hours. The duration of motor blockade does not exceed the duration of analgesia.
+
","Regional anesthesia
","Bupivacaineis a long acting anaesthetic agent of the amide type. Bupivacaine & Dextrosehas a rapid onset of action and long duration. The duration of analgesia in the T10-T12 segments is 2-3 hours. Bupivacaine Hydrochloride produces a moderate muscular relaxation of the lower extremities lasting 2-2.5 hours. The motor blockade of the abdominal muscles makes the solution suitable for performance of abdominal surgery lasting 45-60 minutes.
","The doses recommended below should be regarded as a guide for use in the average adult. Spinal anaesthesia for surgery: 2-4 ml (10-20 mg Bupivacaine hydrochloride). The spread of anaesthesia obtained with Bupivacaine depends on several factors including the volume of the solutions and the position if the patients during and following the injection. When injected in the L3-L4 intervertebral space with the patient in the sitting position, 3 ml of Bupivacaine spreads to the T7- T10 spinal segments. With the patient receiving the injection in the horizontal position and then turned supine, the blockade spine spreads to T4-T7 spinal segments. It should be understood that the level of spinal anaesthetic can be unpredictable in a given patient.
",,"Bupivacaine should be used with care in patients receiving antiarrhythmic drugs with local anaesthetic activity, as their toxic effects may be additive. Phenothiazines and Butyrophenones may reduce or reverse the pressor effect of epinephrine.
","Bupivacaine in Dextrose is contraindicated in patients with a known hypersensitivity to it or to any local anaesthetic agent of the amide type. The following conditions preclude the use of spinal anaesthesia: Severe hemorrhage, severe hypotension or shock and arrhythmias, such as complete heart block, which severely restrict cardiac output,Local infection at the site of proposed lumbar puncture ,Septicemia.
","The adverse reaction profile for Bupivacaine is similar to those for other long acting local anesthetics administered intrathecally. Adverse reactions caused by the drug are difficult to distinguish from the physiological effects of the nerve block (e.g. decrease in blood pressure, bradycardia, temporary urinary retention), events caused directly (e.g. nerve trauma) or indirectly (e.g. epidural abscess) by the needle puncture or events associated to cerebrospinal leakage (eg. postdural puncture headache).
","It is reasonable to assume that a large number of pregnant women and women of child-bearing age have been given Bupivacaine. No specific disturbances to the reproductive process have so far been reported, e.g. no increased incidence of malformations. It should be noted that the dose should be reduced in patients in the late stages of pregnancy
With recommended doses, Bupivacaine enters breast milk in such small quantities that there is generally no risk of affecting the breast feed child. At maternal serum levels of up to 0.45 µg/ml produced by the epidural use of Bupivacaine for vaginal delivery, Bupivacaine could not be detected in breast milk during the first 24 hours after delivery (detection limit 0.02 µg/ml).
","Bupivacaine should be given cautiously to the elderly, the debilitated patients and to children, to patients with epilepsy, respiratory impairment, impaired cardiac conduction, bradycardia, severe shock; porphyria; myasthenia gravis. Myocardial depression may be more severe and more resistant to treatment.
","Use in children: Bupivacaine Hydrochloride is not recommended in patients younger than 18 years of age.
Use in elderly and renal impairment: Patients in poor general condition due to ageing or other compromising factors such as partial or complete heart conduction block, advanced liver or renal dysfunction require special attention, although regional anesthesia may be the optimal choice for surgery in these patients.
","Acute emergencies from local anaesthetics are generally related to high plasma levels encountered during therapeutic use or to underventilation (and perhaps apnea) secondary to upward extension of spinal anaesthesia. Hypotension is commonly encountered during the conduct of spinal anaesthesia due to relaxation of sympathetic tone, and sometimes, contributory mechanical obstruction of venous return.
",,,"Store in a cool and dry place. Protect from light.
",12
+152,Bupivacaine Hydrochloride,bupivacaine-hydrochloride-152,https://medex.com.bd/attachments/7NyLukqyM83wLLxCovbCVwpXh8C0Mj/bupivacaine-hydrochloride-prescribing-information,Regional anesthesia,Regional anesthesia,"Bupivacaine is indicated for the production of local or regional anaesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures. The routes of administration and indicated Bupivacaine concentrations are:
+
+- Local infiltration: 0.25%
... Read more
Bupivacaine is indicated for the production of local or regional anaesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures. The routes of administration and indicated Bupivacaine concentrations are:
+
+- Local infiltration: 0.25%
+- Peripheral nerve block: 0.25%, 0.5%
+- Sympathetic block: 0.25%
+- Lumbar epidural: 0.25%, 0.5% and 0.75% (non-obstetrical)
+- Caudal: 0.25%, 0.5%
+
","Regional anesthesia
","Bupivacaine binds to the intracellular portion of voltage-gated sodium channels and blocks sodium influx into nerve cells, which prevents depolarization. Without depolarization, no initiation or conduction of a pain signal can occur.
The rate of systemic absorption of bupivacaine and other local anesthetics is dependent upon the dose and concentration of drug administered, the route of administration, the vascularity of the administration site, and the presence or absence of epinephrine in the preparation.
+
+- Onset of action (route and dose-dependent): 1-17 min
+- Duration of action (route and dose-dependent): 2-9 hr
+- Half life: neonates, 8.1 hr, adults: 2.7 hr
+- Time to peak plasma concentration (for peripheral, epidural, or caudal block): 30-45 min
+- Protein binding: about 95%
+- Metabolism: hepatic
+- Excretion: renal (6% unchanged)
+
","Percutaneous infiltration anesthesia For prolonged action: 9 mg with adrenaline (1 in 200,000), may repeat 2-10 mins later if needed. Max: 90 mg per dental sitting.
Peripheral nerve block: 12.5 mg (as 0.25% solution) or 25 mg (as 0.5% solution). Max: 150 mg/dose.
Sympathetic nerve block: As 0.25% solution: 50-125 mg.
Retrobulbar block: As 0.75% solution: 15-30 mg.
Caudal block In surgery: 37.5-75 mg (as 0.25% solution) or 75-150 mg (as 0.5% solution). Lumbar epidural block In surgery: 25-50 mg (as 0.25% solution) and 50-100 mg (as 0.5% solution).
",,"Bupivacaine should be used with caution in patients receiving other local anaesthetics or agents structurally related to amide‐type local anaesthetics, e.g. certain anti‐arrhythmics, such as lidocaine and mexiletine, since the systemic toxic effects are additive.Specific interaction studies with Bupivacaine and anti arrhythmic drugs class III (e.g. amiodarone) have not been performed, but caution should be advised.
","Hypersensitivity to Bupivacaine, other amide type local anaesthetics or other components of these preparations; Intravenous regional anaesthesia; obstetrical paracervical block anaesthesia.
","Central Nervous System and Neurological: Restlessness, excitement, nervousness, dizziness, tinnitus, blurred vision, miosis, nausea, vomiting, numbness of the tongue and perioral region, chills, tremors, muscle twitching, convulsions.
Cardiovascular System Reactions: Myocardial depression and peripheral vasodilatation resulting hypotension and bradycardia, ventricular arrhythmia, cardiac arrest.
Hypersensitivity: urticaria, pruritus, erythema, angioneurotic edema ,tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and possibly, anaphylactoid reactions.
","There are no adequate and well‐controlled studies in pregnant women of the effect of bupivacaine hydrochloride on the developing fetus. Bupivacaine should not therefore be given in early pregnancy only if the potential benefit justifies the potential risk to the fetus. Bupivacaine enters the mother's milk, but in such small quantities that there is no risk of affecting the child at therapeutic dose levels.
","Readiness for emergencies.The lowest dosage that gives effective anaesthesia should be used in order to avoid high plasma levels and serious systemic side effects. Injection of repeated doses of Bupivacaine Hydrocholoride may cause significant increase in blood levels with each additional dose, due to accumulation of the drug or its metabolites or due to slow metabolic degradation. Tolerance varies with the status of the patient. Debilitated, elderly patients and acutely ill patients should be given reduced doses commensurate with age and physical condition. Caution is advised in administration of repeat doses of Bupivacaine Hydrocholoride to patients with severe liver disease.Local anaesthetic procedures should be used with caution when there is inflammation and/or sepsis in the region of the proposed injection.
","Paediatrics: For children a reduced dose based on body weight and surface area should be used. The dosage should be calculated for each patient individually and modified in accordance with the physician's experience and knowledge of the patient.
Geriatrics: A reduction in dosage may be necessary for elderly patients especially those with compromised cardiovascular and/or hepatic function. Where epidural administration is to be used, a small dose may provide sufficient anaesthesia
Impaired hepatic function: Although bupivacaine is metabolised by the liver, dosage reduction is probably not warranted. However, caution should be exercised with repeated doses.
Impaired renal function: Impairment of renal function is unlikely to affect bupivacaine clearance in the short term (up to 24 hours). However, toxicity due to accumulation may develop with prolonged or repeated administration.
",,,,"Keep in a cool & dry place, protected from light. Keep out of the reach of children.
",11
+151,Bumetanide,bumetanide-151,https://medex.com.bd/attachments/pwGBkOAUYVA6os0luH5kfo4rWCrlcn/bumetanide-prescribing-information,Loop diuretics,Oedema,"Bumetanide is indicated for the treatment of edema associated with- Congestive heart failure, Hepatic ascites and, Renal disease including the nephrotic syndrome
","Loop diuretics
","Bumetanide is a loop diuretic of the sulfamyl category to treat heart failure. It is often used in patients in whom high doses of furosemide are ineffective. There is however no reason not to use bumetanide as a first choice drug. The main difference between the two substances is in bioavailability. It is said to be a more predictable diuretic, meaning that the predictable absorption is reflected in a more predictable effect. Bumetanide is 40 times more potent than furosemide (for patients with normal renal function).
Bumetanide interferes with renal cAMP and/or inhibits the sodium-potassium ATPase pump. Bumetanide appears to block the active reabsorption of chloride and possibly sodium in the ascending loop of Henle, altering electrolyte transfer in the proximal tubule. This results in excretion of sodium, chloride, and water and, hence, diuresis.
","Oral: 1 mg in the morning , repeated after 6-8 hours if necessary, In severe cases , 5 mg daily increased by 5 mg every 12-24 hours according to response. Elderly , 500 micrograms daily may be sufficient.
Parenteral:
+
+- By IV Injection: 1-2 mg, repeated after 20 minutes if necessary. Elderly, 500 micrograms (1 ml of Bumetanide) daily may be sufficient.
+- By IV Infusion: 2-5 mg over 30-60 minutes.Elderly, 500 micrograms (1 ml of Bumetanide) daily may be sufficient.
+- By IM Injection: 1 mg initially then adjusted according to response , Elderly 500 micrograms (1 ml of Bumetanide) daily may be sufficient.
+
",,"Concomitant use of Bumetanide may potentiate the effects of antihypertensive drugs. It shows a tendency to increase the excretion of potassium which can lead to an increase in the sensitivity of the myocardium to the toxic effects of digitalis. As with other diuretics, Bumetanide may cause an increase in blood uric acid.
","Loop diuretics should be avoided in severe hypokalaemia, severe hyponatraemia, anuria, comatose and precomatose states associated with liver cirrhosis and in renal failure.
","The side effects of Bumetanide include: headache, dizziness, fatigue, postural hypotension and gastrointestinal symptoms. Various skin reactions, photosensitivity reactions and metabolic disturbances, including reduced glucose tolerance are less frequent. Electrolyte disturbances can occur especially during long term treatment.
","Pregnancy Category C. There are no adequate and well controlled studies in pregnant woman. It is not known wheather this drug is excreted in human milk.
","Serum potassium should be measured periodically and potassium supplements or potassium sparing diuretics added if necessary.
","Paediatric use: Safety and effectiveness in paediatric patients below the age of 18 have not been established.
","Symptoms would be those caused by excessive diuresis. Empty stomach by gastric lavage or emesis.
",,,"Store in a cool & dry place. Protect from light.
",12
+150,Budesonide + Formoterol Fumarate,budesonide-formoterol-fumarate-150,https://medex.com.bd/attachments/diryDGQG154sGCxp2jrVtLvlTMEIEn/budesonide-formoterol-fumarate-prescribing-information,,,"This is indicated in the regular treatment of asthma. They are also indicated in the symptomatic treatment of severe chronic obstructive pulmonary disease (COPD), with a history of repeated exacerbations despite regular therapy with long-acting bronchodilators.
",,"Budesonide: It is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have a wide range of inhibitory activities against multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic and non-allergic mediated inflammation. These anti-inflammatory actions of corticosteroids may contribute to their efficacy in asthma.
Formoterol Fumarate Dihydrate: It is a long-acting, selective β2 - adrenergic agonist with a rapid onset of action. Inhaled Formoterol Fumarate Dihydrate BP acts locally in the lungs as a bronchodilator. The pharmacological effects of β2-adrenoceptor agonist drugs are attributable to the stimulation of intracellular adenyl cyclase, the enzyme that catalyses the conversion of adenosine triphosphate (ATP) to cyclic AMP. Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibit the release of mediators of immediate hypersensitivity from the cells, especially from mast cells.
","Inhaler (For Asthma)-
+
+- Adults and adolescents (12 years and older): The recommended maintenance dose is 1 puff twice daily or 2 puffs once daily. For some patients a maintenance dose of 2 puffs twice daily may be appropriate (for 160/4.5 mcg/inhalation only). Patients should take 1 additional puff as needed in response to symptoms. If symptoms persist after a few minutes, the additional puff should be taken. Not more than 6 puffs should be taken on any single occasion.
+
+
+- Children: The usual maintenance dose is 1 -2 puffs once or twice daily. Patients should take 1 additional puff as needed in response to symptoms. If symptoms persist after a few minutes, the additional puff should be taken. Not more than 4 puffs should be taken on any single occasion.
+
+
Inhalation Capsule (For Asthma): There are two alternative dosage regimens for the treatment of asthma with Budesonide and Formoterol combination. Budesonide and Formoterol 100 & 200 Inhalation Capsule maintenance and reliever therapy.
Adults and adolescents (12 years and older):
+
+- Maintenance dose: Budesonide and Formoterol 100 & 200 Inhalation Capsule twice daily
+- Reliever dose: 1 additional Inhalation Capsule as needed in response to symptoms. If symptoms persist after a few minutes, an additional Inhalation Capsule should be taken. Not more than 6 Inhalation Capsule should be taken on any single occasion. A total daily dose of more than 8 Inhalation Capsule is not normally needed, however, a total daily dose of up to 12 Inhalation Capsule can be used temporarily.
+
+Children (4 years and older):
+
+- Maintenance dose: Budesonide and Formoterol 100 Inhalation Capsule once daily.
+- Reliever dose: 1 additional Inhalation Capsule as needed in response to symptoms. If symptoms persist after a few minutes, an additional Inhalation Capsule should be taken. Not more than 4 Inhalation Capsule should be taken on any single occasion. A total daily dose of more than 4 Inhalation Capsule is not normally needed, however, a total daily dose of up to 8 Inhalation Capsule could be used temporarily.
+
+
Inhalation Capsule (For COPD): Adults (40 years and older)
+
+- 200 Inhalation Capsule: 2 Inhalation Capsule twice daily. Maximum daily maintenance dose: 4 Inhalation Capsule
+- 400 Inhalation Capsule: 1 Inhalation Capsule twice daily. Maximum daily maintenance dose: 2 Inhalation Capsule.
+
","Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.
Following simple steps can help to use Inhaler effectively (According to ""
National Asthma Guidelines for Medical Practitioners"" published by Asthma Association):
+
+- Take off the cap.
+- Shake the inhaler (at least six times) vigorously before each use.
+- If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
+- Breathe out as full as comfortably possible & hold the inhaler upright.
+- Place the actuator into mouth between the teeth and close lips around the mouthpiece.
+- While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
+- Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
+- If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
+- After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
+- Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.
+
+
Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.
","Concomitant treatment with Ritonavir, Itraconazole, Ketoconazole or other potent CYP3A4 inhibitors should be avoided.
","Hypersensitivity to Budesonide, Formoterol or to Lactose.
","Budesonide: Hoarseness, and candidiasis (thrush) of the mouth and throat can occur in some patients. Cutaneous hypersensitivity reactions have been reported.
Formoterol Fumarate Dihydrate: Tremor, palpitations, and headache have been reported. Cardiac arrhythmias, muscle cramps, and hypersensitivity reactions, including rash, oedema, and angio-oedema, may occur in some patients.
","Administration of Budesonide & Formoterol Fumarate in pregnant women and lactating mother should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus
","Treatment with Budesonide and Formoterol combination should not be initiated to treat a severe exacerbation or if patients have significantly worsening or acutely deteriorating asthma.
","It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be re evaluated with the aim of reducing the dose of inhaled corticosteroid. The benefits of the corticosteroid therapy and the possible risks of growth suppression must be carefully weighed. In addition consideration should be given to referring the patient to a paediatric respiratory specialist.
",,,,"Protect from light, store in cool & dry place. Do not store above 30° C. Keep out of the reach of children. Protect from freezing.
",11
+1653,Budesonide (Tablet),budesonide-tablet-1653,https://medex.com.bd/attachments/49Js6FxlL6RntjoksKsqCe5K8B23uD/budesonide-tablet-prescribing-information,Ulcerative Colitis,Ulcerative colitis,"Budesonide tablet is a glucocorticoid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.
","Ulcerative Colitis
","Budesonide is a synthetic corticosteroid having potent glucocorticoid activity and weak mineralocorticoid activity. It has approximately 200-fold higher affinity for the glucocorticoid receptor than cortisol and 15-fold than prednisolone. Budesonide is effective against inflammatory bowel diseases. It reduces inflammation of colon and also helps heal the lining of the colon.
","Adult: One 9 mg Budesonide extend release tablet should be taken once daily in the morning with or without food for up to 8 weeks or as prescribed by the doctor.
Use in children: Safety and effectiveness of budesonide in pediatric patients have not been established.
Use in Hepatic Impaired patients: Monitor patients for signs and/or symptoms of hypercorticism.
",,"Avoid Cytochrome P450 3A4 inhibitors (e.g. ketoconazole, grapefruit juice). It may cause increased systemic corticosteroid effects. Budesonide does not affect the plasma levels of oral contraceptives.
",,"Common side effects are headache, nausea, upper abdominal pain, fatigue, acne, flatulence, joint pain, urinary tract infection, abdominal distension, constipation.
","Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Budesonide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Budesonide is secreted in human milk. So, a decision should be made whether to discontinue nursing or budesonide taking into account the clinical importance of the drug to the mother.
","
+- Since budesonide is a glucocorticoid, general warnings concerning glucocorticoids should be followed.
+- Risk of impaired adrenal function when transferring from glucocorticoid treatment with higher systemic effects to glucocorticoid treatment with lower systemic effects, such as budesonide. Taper patients slowly from systemic corticosteroids if transferring to budesonide.
+- Potential worsening of infections (e.g., chickenpox, measles, existing tuberculosis, fungal, bacterial, viral, or parasitic infection). Use with caution in patients with these infections.
+- Reduced liver function affects the elimination of glucocorticoid, and increases systemic availability of oral budesonide.
+
",,"If glucocorticoids are used at excessive doses for prolonged periods, systemic glucocorticoid effects such as hypercorticism and adrenal suppression may occur.
",,,"Budesonide extended-release tablets should be stored below 30°C. Store in a cool and dry place protected from light and moisture.
",10
+146,Budesonide (Nebuliser Suspension),budesonide-nebuliser-suspension-146,https://medex.com.bd/attachments/OJc9J1WZwLln302GnBBmJ27yqh3wPw/budesonide-nebuliser-suspension-prescribing-information,Nasal Decongestants & Other Nasal Preparations,Asthma,"Budesonide nebuliser suspension is indicated for the maintenance treatment and as prophylactic therapy of asthma.
","Nasal Decongestants & Other Nasal Preparations, Respiratory corticosteroids
","Budesonide is a synthetic corticosteroid having potent glucocorticoid activity and weak mineralocorticoid activity. It has approximately a 200-fold higher affinity for the glucocorticoid receptor and a 1000-fold higher topical anti-inflammatory potency than cortisol. Corticosteroids have been shown to have a wide range of inhibitory activities against multiple cell types (e.g., mast cell, eosinophil, neutrophil, macrophage, and lymphocyte) and mediators (e.g., histamine, eicosanoids, leukotriene, and cytokine) involved in allergic mediated inflammation.
","Children 3 months to 12 years of age: 0.5-1 mg twice daily.
Adults and elderly: 1-2 mg twice daily.
",,"No significant drug interactions have been reported.
","Hypersensitivity to any of the ingredients of this preparation.
","Sneezing, headache, sore throat, dry mouth, nausea etc. have been reported as the common side effects
","Pregnancy: There are no adequate and well-controlled studies in pregnant women. Budesonide nebuliser suspension, like other corticosteroids, should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is not known whether Budesonide is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be exercised when Budesonide nebuliser suspension is administered to nursing women.
","Budesonide nebuliser suspension should be used with caution in patients with active or quiescent tuberculous infection, untreated fungal, bacterial, or systemic viral infections, or ocular herpes simplex infection.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+1652,Budesonide (Nasal Spray),budesonide-nasal-spray-1652,https://medex.com.bd/attachments/qcShJRObNKvHfdnoIokY1ZRqBSRAmA/budesonide-nasal-spray-prescribing-information,Nasal Decongestants & Other Nasal Preparations,Vasomotor rhinitis,"
+- Prophylaxis and treatment of seasonal and perennial allergic rhinitis.
+- Prophylaxis and treatment of vasomotor rhinitis.
+- Symptomatic relief of nasal polyposis.
+- Prevention against nasal polyps after polypectomy.
+
","Nasal Decongestants & Other Nasal Preparations, Respiratory corticosteroids
","Budesonide is a synthetic corticosteroid having potent glucocorticoid activity and weak mineralocorticoid activity. It has approximately a 200-fold higher affinity for the glucocorticoid receptor and a 1000-fold higher topical anti-inflammatory potency than cortisol. Corticosteroids have been shown to have a wide range of inhibitory activities against multiple cell types (e.g. mast cell, eosinophil, neutrophil, macrophage, and lymphocyte) and mediators (e.g. histamine, eicosanoids, leukotriene, and cytokine) involved in allergic mediated inflammation.
","Adults and children 6 years of age and older: 100 mcg per day administered as one spray per nostril once daily.
Adults (12 years of age and older): The maximum recommended dose is 400 mcg per day administered as four sprays per nostril once daily.
Pediatric Use: Safety and effectiveness in pediatric patients below 6 years of age have not been established.
","How to use the Nasal Spray-
+
+- Shake the bottle gently and remove the dust cover.
+- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
+- Gently blow the nose to clear the nostrils.
+- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
+- Breathe out through your mouth.
+- Repeat the above steps in the same/ other nostril for consecutive doses.
+
+Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-
+
+- Remove the dust cover.
+- Gently pull off the nasal applicator.
+- Wash the applicator and dust cover in warm water.
+- Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
+- Gently push the applicator back on the top of the bottle and re-fix the dust cover.
+
","No significant drug interaction has been reported.
",,"Adverse local reactions following budesonide use are mild and usually transient. Systemic side effects have not been reported during clinical studies of budesonide nasal preparations. Sneezing, headache, sore throat, dry mouth, nausea etc. have been reported as the common side effects.
","Pregnancy: Inhaled budesonide has been assigned to pregnancy category B by the FDA. Budesonide has not been shown to be teratogenic in animals when given in high doses by inhalation. Despite the animal findings, it would appear that the possibility of fetal harm is remote if the inhaled drug is used during pregnancy. Nevertheless, because the studies in humans cannot rule out the possibility of harm, inhaled budesonide should be used during pregnancy only if clearly needed.
Lactation: The amounts of inhaled budesonide excreted into breastmilk are minute and infant exposure is negligible. Reviewers and an expert panel consider inhaled corticosteroids acceptable to use during breastfeeding. When taken by mouth, budesonide is only about 9% bioavailable; bioavailability in the infant is likely to be similarly low for any budesonide that enters the breastmilk.
","Budesonide nasal spray should be used with caution in patients with active or quiescent tuberculous infection, untreated fungal, bacterial, or systemic viral infections, or ocular herpes simplex infection. Patients with recent nasal septal ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid.
",,"Like any other nasally administered corticosteroids, acute overdosing is unlikely in view of the total amount of active ingredient present. Clinically significant systemic adverse events would most likely not occurs if the entire contents of the bottle were administered all at once, via either oral or nasal application. Chronic overdosage may result in signs/symptoms of hypercorticism.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+1654,Budesonide (Inhaler),budesonide-inhaler-1654,https://medex.com.bd/attachments/oAaVWQnb7QNJCxa4lDmql8nik4wT9r/budesonide-inhaler-prescribing-information,Nasal Decongestants & Other Nasal Preparations,Asthma,"Budesonide inhaler is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and paediatric patients six years of age or older. It is also indicated for patients requiring oral corticosteroid therapy for asthma, many of those patients may be able to reduce or eliminate their ... Read more
Budesonide inhaler is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and paediatric patients six years of age or older. It is also indicated for patients requiring oral corticosteroid therapy for asthma, many of those patients may be able to reduce or eliminate their requirement for oral corticosteroids over time. Budesonide inhaler is not indicated for the relief of acute bronchospasm.
","Nasal Decongestants & Other Nasal Preparations, Respiratory corticosteroids
","Budesonide inhaler is a corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity. Corticosteroids have been shown to have a wide range of inhibitory activities against multiple cell types (e.g., mast cells, oeosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic and non-allergic inflammation. These anti-inflammatory actions of Budesonide contribute to its efficacy in asthma.
","Budesonide inhaler should be administered by the orally inhaled route in asthmatic patients age 6 years and older. Individual patients will experience a variable onset and degree of symptom relief. Generally, Budesonide inhaler has a relatively rapid onset of action for an inhaled corticosteroid. Improvement in asthma control following inhaled administration of Budesonide inhaler can occur within 24 hours of initiation of treatment, although maximum benefit may not be achieved for 1 to 2 weeks, or longer. The safety and efficacy of Budesonide inhaler, when administered in excess of recommended doses, have not been established.
Adult: Bronchodilators alone-
+
+- Recommended starting dose: 200 to 400 mcg twice daily
+- Highest recommended dose: 400 mcg twice daily
+
+
Adult: Inhaled corticosteroids**-
+
+- Recommended starting dose: 200 to 400 mcg twice daily
+- Highest recommended dose: 800 mcg twice daily
+
+
Adult: Oral corticosteroids-
+
+- Recommended starting dose: 400 to 800 mcg twice daily
+- Highest recommended dose: 800 mcg twice daily
+
+
Children: Bronchodilators alone-
+
+- Recommended starting dose: 200 mcg twice daily
+- Highest recommended dose: 400 mcg twice daily
+
+
Children: Inhaled corticosteroids**-
+
+- Recommended starting dose: 200 to 400 mcg twice daily
+- Highest recommended dose: 400 mcg twice daily
+
+
Children: Oral corticosteroids-
+
+- Recommended dose: The highest recommended dose in children is 400 mg twice daily
+
+**In patients with mild to moderate asthma who are well controlled on inhaled corticosteroids, dosing with Budesonide inhaler 200 mg or 400 mg once daily may be considered. Budesonide inhaler can be administered once daily either in the morning or in the evening.
If the once daily treatment with Budesonide inhaler does not provide adequate control of asthma symptoms, the total daily dose should be increased and/or administered in divided doses.
Patients maintained on chronic oral corticosteroids: Initially, Budesonide inhaler should be used concurrently with the patient’s usual maintenance dose of systemic corticosteroid. After approximately one week, gradual withdrawal of the systemic corticosteroid is started by reducing the daily or alternate daily dose. The next reduction is made after an interval of one or two weeks, depending on the response of the patient. Generally, these decrement should not exceed 2.5 mg of Prednisone or its equivalent. A slow rate of withdrawal is strongly recommended. During reduction of oral corticosteroids, patients should be carefully monitored for asthma instability, including objective measures of airway function, and for adrenal insufficiency. During withdrawal, some patients may experience symptoms of systemic corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude and depression, despite maintenance or even improvement in pulmonary function. Such patients should be encouraged to continue with Budesonide Inhaler but should be monitored for objective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, the systemic corticosteroid dose should be increased temporarily and thereafter withdrawal should be continued more slowly. During periods of stress or a severe asthma attack, transferred patients may require supplementary treatment with systemic corticosteroids.
","Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.
Following simple steps can help to use Inhaler effectively (According to ""
National Asthma Guidelines for Medical Practitioners"" published by Asthma Association):
+
+- Take off the cap.
+- Shake the inhaler (at least six times) vigorously before each use.
+- If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
+- Breathe out as full as comfortably possible & hold the inhaler upright.
+- Place the actuator into mouth between the teeth and close lips around the mouthpiece.
+- While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
+- Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
+- If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
+- After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
+- Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.
+
+
Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.
",,"Budesonide inhalation aerosol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Hypersensitivity to Budesonide contraindicates the use of Budesonide inhaler.
","The following adverse reactions were reported in patients treated with Budesonide inhaler.
+
+- General: Headache, flu-like syndrome, pain, back pain, fever, neck pain, asthenia.
+- Respiratory system: Respiratory tract infections, pharyngitis, sinusitis, rhinitis, voice alteration, cough aggravation.
+- Digestive system: Oral candidiasis, dyspepsia, gastroenteritis, nausea, abdominal pain, dry mouth, vomiting.
+- Metabolic and Nutritional: Weight gain.
+- Musculoskeletal: Fracture, myalgia, arthralgia.
+- Nervous system: Syncope, hypertonia, migraine.
+- Skin: Ecchymosis.
+- Psychiatric: Insomnia.
+- Resistance Mechanisms: Infection.
+- Special Senses: Taste perversion.
+
",,"During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement of respiratory function. Budesonide inhaler will often permit control of asthma symptoms with less suppression of hypothalamic-pituitary-adrenal (HPA) function than therapeutically equivalent oral doses of Prednisone. Since Budesonide is absorbed into the circulation and can be systemically active at higher doses, the full beneficial effects of Budesonide inhaler in minimising HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose. Since individual sensitivity to effects on cortisol production exists, physicians should consider this fact when prescribing Budesonide inhaler.
","Paediatric studies: There were no clinically relevant differences in the pattern or severity of adverse events in children compared with those reported in adults.
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+149,Bromocriptine Mesylate,bromocriptine-mesylate-149,https://medex.com.bd/attachments/2J8uwX5RK1VHRXDWTd4HJEWSD0nOaR/bromocriptine-mesylate-prescribing-information,Antiparkinson drugs,Restless leg syndrome,"Hyperprolactinemia-Associated Dysfunctions: Dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism.
Prolactin secreting adenomas: ln cases where adenectomy is elected, a course of bromocriptine ... Read more
Hyperprolactinemia-Associated Dysfunctions: Dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism.
Prolactin secreting adenomas: ln cases where adenectomy is elected, a course of bromocriptine mesilate therapy may be used to reduce the tumor mass prior to surgery.
Acromegaly: Parkinson's Disease: Idiopathic or postencephalitic Parkinson's disease- As adjunctive treatment to levodopa (alone or with a peripheral decarboxylase inhibitor).
","Antiparkinson drugs, Motility stimulants/Dopamine antagonist
","Bromocriptine mesilate is a nonhormonal, nonestrogenic agent that inhibits the secretion of prolactin in humans, with little or no effect on other pituitary hormones, except in patients with acromegaly, where it lowers elevated blood levels of growth hormone. Bromocriptine mesilate is a dopamine receptor agonist, which activates post-synaptic dopamine receptors.The dopaminergic neurons in the tuberoinfundibular process modulate the secretion of prolactin from the anterior pituitary by secreting a prolactin inhibitory factor (thought to be dopamine); in the corpus striatum the dopaminergic neurons are involved in the control of motor function. Clinically, it significantly reduces plasma levels of prolactin in patients with physiologically elevated prolactin as well as in patients with hyperprolactinemia.
","General: It is recommended that Bromocriptine mesilate be taken with food. Patients should be evaluated frequently during dose escalation to determine the lowest dosage that produces a therapeutic response.
Hyperprolactinemic lndications: The initial dosage is 0.5 mg to 2.5 mg tablet daily. An additional 2.5 mg tablet may be added to the treatment regimen as tolerated as tolerated every 2-7 days until an optimal therapeutic response is achieved.Based on limited data in children of age 11 to 15 the initial dose is 0.5 to 2.5 mg tablet daily. Dosing may need to be increased as tolerated until a therapeutic response is achieved. The therapeutic dosage ranged from 2.5-10 mg daily in children with prolactin-secreting pituitary adenomas.
Acromegaly: The initial recommended dosage is 0.5 to 2.5 mg on retiring (with food) for 3 days. An additional 0.5 to 2.5 mg should be added to the treatment regimen as tolerated every 3-7 days until patient obtains optimal therapeutic benefit. The maximal dosage should not exceed 100 mg/day.
Parkinson's disease: The basic principle of bromocriptine mesilate therapy is to initiate treatment at a low dosage. The initial dose of Bromocriptine mesilate is 0.5 of a 2.5 mg tablet twice daily with meals. If necessary,the dosage may be increased every 14-28 days by 2.5 mg/day with meals.The safety of bromocriptine mesilate has not been demonstrated in dosages exceeding 100 mg/day.
",,"Bromocriptine may interact with dopamine antagonists, butyrophenones, and certain other agents. Compounds in these categories result in a decreased efficacy of Bromocriptine: phenothi-azines, haloperidol, metodopramide, pimozide. Concomitant use of Bromocriptine with other ergot alkaloids is not recommended.
","
+- Uncontrolled hypertension and sensitivity to any ergot alkaloids. In patients being treated for hyperprolactinemia Bromocriptine mesilate should be withdrawn when pregnancy is diagnosed.
+- Post partum period in women with a history of coronary artery disease & other severe cardiovascular conditions.
+
","Side effects in decreasing order of frequency are: nausea, headache, dizziness, fatigue, lightheadedness, vomiting, abdominal cramps, nasal congestion constipation, diarrhea and drowsiness. A slight hypotensive effect may accompany treatment. The occurrence of adverse reactions may be lessened by temporarily reducing dosage to 0.5 mg. Abnormalities in laboratory tests may include elevations in blood urea nitrogen, SGOT, SGPT, GGPT, CPK, alkaline phosphatase and uric acid,which are usually transient and not of clinical significance
","Pregnancy category B. Bromocriptine should not be used during lactation in postpartum women.
","Safety and efficacy of bromocriptine mesilate have not been established in patients with renal or hepatic disease. Care should be exercised when administering Bromocriptine therapy concomitantly with other medications known to lower blood pressure.The drug should be used with caution in patients with a history of psychosis or cardiovascular disease. If acromegalic patients or patients with prolactinoma or Parkinson's disease are being treated with Bromocriptine during pregnancy, they should be cautiously observed.
","Pediatric use: No data are available for bromocriptine use in pediatric patients under the age of 8 years
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+84,Aspartame,aspartame-84,,Oral nutritional preparations,Sugar substitute,"Used as a diet supplement and sugar substitute.
","Oral nutritional preparations
","Aspartame is a low-calorie sweetener used to sweeten a wide variety of low- and reduced-calorie foods and beverages, including low-calorie tabletop sweeteners. Aspartame is composed of two amino acids, aspartic acid and phenylalanine, as the methyl ester. Aspartic acid and phenylalanine are also found naturally in protein containing foods, including meats, grains and dairy products. Methyl esters are also found naturally in many foods such as fruits and vegetable and their juices. Upon digestion, aspartame breaks down into three components (aspartic acid, phenylalanine and methanol), which are then absorbed into the blood and used in normal body processes. Neither aspartame nor its components accumulates in the body. These components are used in the body in the same ways as when they are derived from common foods.
Aspartame is 180 to 200 times sweeter than sucrose, it is metabolized as a protein and its subsequent amino-acids used up in there respective mechanisms.
","According to individual taste. 1 pellet is equivalent in sweetness to 1 tsf of sugar.
",,"There are no known drug interactions and none well documented.
","Complete biliary obstruction, hypersensitivity.
","Constipation; faecal impaction; haemorrhoids; abdominal discomfort or pain; heartburn; flatulence; nausea; vomiting; diarrhoea; increased bleeding tendency (chronic use); osteoporosis; steatorrhoea (high doses); skin rashes; pruritus of the tongue, skin and perianal region; hyperchloraemic acidosis.
","Pregnancy Category-C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
","If pregnant or breast-feeding, seek advice of a health professional before use.
",,,,,,9
+83,Articaine Hydrochloride + Epinephrine,articaine-hydrochloride-epinephrine-83,https://medex.com.bd/attachments/Tz2mu9DmPWHEUpFccyQWA2dFG7vsF8/articaine-hydrochloride-epinephrine-prescribing-information,Local & Surface anesthesia,Local anaesthesia,"Articaine and Epinephrine is an amide local anesthetic containing a vasoconstrictor indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures.
","Local & Surface anesthesia
","Articaine is an amide local anesthetic. Local anesthetics block the generation and conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination, and conduction velocity of the affected nerve fibers. Epinephrine is a vasoconstrictor added to articaine to slow absorption into the general circulation and thus prolong maintenance of an active tissue concentration.
","Below are the recommended volumes and concentrations of articaine-epinephrine for various types of anesthetic procedures. The dosages suggested below are for normal healthy adults, administered by submucosal infiltration and/or nerve block.
Infiltration: 0.5 mL to 2.5 mL or 20 mg to 100 mg of articaine
Nerve block: 0.5 mL to 3.4 mL or 20 mg to 136 mg of articaine
Oral surgery: 1.0 mL to 5.1 mL or 40 mg to 204 mg of articaine.
For normal healthy adults, the maximum dose of articaine administered by submucosal infiltration and/or nerve block should not exceed 7 mg/kg of body weight.
",,"The administration of local anesthetic solutions containing epinephrine to patients receiving monoamine oxidase inhibitors, nonselective beta-adrenergic antagonists or tricyclic antidepressants may produce severe, prolonged hypertension. Phenothiazines and butyrophenones may reduce or reverse the pressor effect of epinephrine. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential
","Articaine HCl and Epinephrine is contraindicated in patients who are hypersensitive to products containing sulfites. Products containing sulfites may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people
","Common side effects include Pain, headache, facial edema, gingivitis, paresthesia, infection. Other side effects include pain, headache, positive blood aspiration into syringe, swelling, face edema, infection, neck pain, abdominal pain, ear pain, taste perversion, and accidental injury have been reported
Gastrointestinal side effects including nausea and emesis, gingivitis, constipation, diarrhea, dyspepsia, glossitis, gum hemorrhage, mouth ulceration, nausea, stomatitis, tongue edema, tooth disorder, and vomiting have been reported.
Musculoskeletal side effects including trismus, arthralgia, myalgia, back pain, and osteomyelitis have been reported.
General side effects including sleepiness, malaise, and asthenia have been reported.
Nervous system side effects including paresthesia, numbness and tingling, dizziness, dry mouth, facial paralysis, hyperesthesia, increased salivation, nervousness, neuropathy, paresthesia, somnolence, and exacerbation of Kearns-Sayre syndrome have been reported.
Cardiovascular side effects including palpitation, hemorrhage, migraine, syncope, tachycardia, and elevated blood pressure have been reported.
Respiratory side effects including pharyngitis, rhinitis, sinus pain, and sinus congestion have been reported.
","Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women with articaine with epinephrine. This should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether Articaine and Epinephrine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this combination is administered to a nursing woman.
",,"Pediatric Use: Safety of doses greater than 7 mg/kg of articaine in pediatric patients has not been established. Dosages in pediatric patients should be reduced, commensurate with age, body weight, and physical condition.
Renal or Hepatic Insufficiency: No studies have been performed with articaine and epinephrine in renal and hepatic impaired patient.
",,,,,9
+82,Artesunate,artesunate-82,,Anti-malarial drugs,Malaria,"Artesunate, an artemisinin derivative, is a powerful antimalarial drug. It is used for both adults and children. It is indicated for the following conditions:
+
+- Treatment of severe and complicated malaria caused by Plasmodium falciparum both in adults and in children in areas where there is multidrug resistance.
... Read more
Artesunate, an artemisinin derivative, is a powerful antimalarial drug. It is used for both adults and children. It is indicated for the following conditions:
+
+- Treatment of severe and complicated malaria caused by Plasmodium falciparum both in adults and in children in areas where there is multidrug resistance.
+- Treatment of uncomplicated malaria in situations where there is the widespread prevalence of multidrug-resistant Plasmodium falciparum.
+
+Artesunate tablet is also suitable to salvage patients with pernicious malaria and treat malaria caused by Plasmodium falciparum and Plasmodium vivax.
","Anti-malarial drugs
","Artesunate is metabolized to the active DHA. the endoperoxide bridge of DHA reacts with heme, generating free radicals which inhibit protein and nucleic acid synthesis of the Plasmodium parasites during all erythrocytic stages. Reactions with these free radicals can also lead to alkylation of parasitic proteins such as a calcium adenosine triphosphatase and EXP1, a glutathione S-transferase.
","It is to be given by oral route. The oral dose of Artesunate tablet can be defined as follows:
For Artesunate 50 mg tablet:
Adults:
+
+- Two Artesunate 50 tablets twice on the first day, then
+- one Artesunate 50 tablet twice daily for the next four days (4, 2, 2, 2, 2)
+
+Children:
+
+- 1-3 years: 3 Artesunate 50 tablets for 5 days (1, 1⁄2, 1⁄2, 1⁄2, 1⁄2)
+- 4-5 years: 6 Artesunate 50 tablets for 5 days (2, 1, 1, 1, 1)
+- 6-12 years: 8 Artesunate 50 tablets for 5 days (3, 2, 1, 1, 1)
+
+
For Artesunate 100 mg tablet:
Adults: One Artesunate 100 tablet twice on the first day, then half Artesunate 100 tablet twice daily for the next four days (2, 1, 1, 1, 1)
Children:
+
+- 4-5 years: 3 Artesunate 100 tablets for 5 days (1, 1⁄2, 1⁄2, 1⁄2, 1⁄2)
+- 6-12 years: 4 Artesunate 100 tablets for 5 days (11⁄2,1,1⁄2,1⁄2,1⁄2)
+- Patients aged more than 12 years: should be given same as adult dose.
+
+Dosage for the prevention of malaria: Two Artesunate 50 tablets (or one Artesunate 100 tablet) as a single dose once a week, from one week before entering a malaria-affected area to four weeks after leaving the area.
",,"Artesunate may have interaction with other artemisinin drugs i.e. artemether, arteether which have the same effect in prolonging the PQ and QT interval. It has interaction when it is given with other antimalarial drugs (eg. Quinine, quinidine, mafloquine and halofantrine) which have cardiac action. It also has interaction with other drugs which prolong QT interval (such as erythromycin, terfenadine, astemizole, probucol, procainamide, disopyramide, amiodarone, bretylium, bepridil, sotalol, tricyclic antidepressants and neuroleptics).
","Artesunate is contraindicated for patients with known hypersensitivity to Artemisinin and its derivatives or its inactive ingredients.
","Artesunate tablet is well tolerated. No adverse effects have been reported from the treatment of artesunate at recommended dose.
","A WHO report assessing the safety of artemisinin derivatives in pregnancy concluded that these drugs should continue to be available for the treatment of malaria in pregnancy, irrespective of the trimester. WHO also stressed that further study was needed. Therefore Artesunate tablet should be given to pregnant women especially, in first trimester if recommended by Registered Physician. Like many other drugs there is possibility for presence of artesunate in breast milk. Because of potential of adverse effect of artesunate in nursing baby, breast-feeding should be stopped during the treatment of malaria by Artesunate tablet.
","
+- This tablet should be used with caution in patients vomiting severely.
+- For emergency treatment of patients suffering from severe malaria, intravenous or intramuscular injection is preferred.
+- Do not use the drug without the advice of a Registered Physician.
+- Do not exceed the recommended dose.
+
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+1732,Licorice + Yellow Silk Cotton + Mastic tree,licorice-yellow-silk-cotton-mastic-tree-1732,,Herbal and Nutraceuticals,Hyperacidity,"This is indicated in-
+
+- Hyperacidity
+- Gastric ulcer
+- Duodenal ulcer
+
","Herbal and Nutraceuticals
","This is a unique combination of Licorice (Glycyrrhiza glabra), Yellow Silk Cotton (Cochiospermum religiosum) and other precious natural ingredients. It is very effective in hyperacidity, gastric ulcer & duodenal ulcer.
","1 teaspoonful 3 times daily before meal or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1731,Licorice + Vasaka + Basil + Peppermint,licorice-vasaka-basil-peppermint-1731,,Herbal and Nutraceuticals,Tonsillitis,"This is indicated in-
+
+- Influenza
+- Bronchitis
+- Tonsillitis
+- Sore throat
+- Hoarseness
+- Cold and cough
+- Congestion of lungs and head
+
","Herbal and Nutraceuticals
","This is a research product of Hamdard Laboratories. It is an amazing combination valuable medicinal plants of time tested proven efficacy, like Licorice (Glycyrrhiza glabra), Vasaka (Adhatoda vasica), Basil (Ocimum sanctum) etc. This is very effective in the treatment of respiratory disorders. It is effective in cough and other symptoms of colds, bronchitis, tonsillitis, influenza, tuberculosis, sore throat, irritation in the throat and as an expectorant helps loosen phlegm deposit in the airway.
","Adult: 2 tablets to be chewed 3-4 times a day
Children (6-12 years): 1 tablet to be chewed 3-4 times a day or as prescribed by the physician. It is highly effective when taken with hot water.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1697,Lavendar [Lavendula stoechas],lavendar-lavendula-stoechas-1697,,Herbal and Nutraceuticals,Headache,"This is indicated in-
+
+- Chronic catarrh
+- Headache
+- Epilepsy
+- Nervous debility
+- Weak vision
+- Paralysis
+
","Herbal and Nutraceuticals
","This is a unique combination of Lavendar (Lavendula stoechas) and other natural ingredients, which is very effective in the treatment of headache and chronic catarrh. It strengthens the brain, relieves emotional tension, depression and insomnia. It stimulates nerves that beneficial in the treatment of paralysis, epilepsy and weak vision.
","1-2 teaspoonful(s) 1-2 times daily or as prescribed by the physicians.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Protect from light. Keep in cool & dry place.
",8
+1730,Kusta Qalyee [Calcined stannum],kusta-qalyee-calcined-stannum-1730,,Herbal and Nutraceuticals,Vaginal leucorrhoea,"This is indicated in-
+
+- Spermatorrhoea
+- Oligospermia
+- Premature ejaculation
+- Leucorrhoea
+
","Herbal and Nutraceuticals
","This is a unique unani medicine, prepared with the valuable natural ingredients, which is highly effective in the treatment of spermatorrhoea, oligospermia and premature ejaculation. It is also effective in leucorrhoea.
","1-2 tablet(s) 1-2 time(s) daily or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Protect from light. Keep in cool & dry place. Shake well before use.
",8
+1698,Khakshi,khakshi-1698,,Herbal and Nutraceuticals,Typhoid fever,"Khakshi is indicated in-
+
+- Fever
+- Influenza
+- Typhoid
+- Paratyphoid
+- Measles
+- Chickenpox
+
","Herbal and Nutraceuticals
","Khakshi is a unique combination of valuable natural ingredients. The main ingredient of Fevnil Wild Mustard (Sisymbrium irio) contains sinigrin which acts as febrifuge, antibacterial (especially effective against Salmonella typhi, Salmonella paratyphi) and antiviral. Khakshi is very effective in typhoid, paratyphoid, measles & chicken pox. Khakshi is immunostimulant, demulcent, alterative, analgesic & hepatoprotective.
","Adults: 2-4 teaspoonfuls 2-3 times daily.
Children: 1/2-1 teaspoonfuls 2-3 times daily or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place protect from light.
",8
+72,Anastrozole,anastrozole-72,https://medex.com.bd/attachments/eWPbXIu1EEBLiQcs1AYdRkhaDvKqYs/anastrozole-prescribing-information,Hormonal Chemotherapy,Ovulation induction,"Anastrozole is indicated in-
+
+- Treatment of early breast cancer in hormone receptor positive post-menopausal women.
+- Adjuvant treatment of early breast cancer in hormone receptor positive
+- postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.
+- Reduction in the incidence of contralateral breast cancers in post menopausal women receiving Anastrozole as adjuvant treatment for early breast cancer.
+- Treatment of advanced breast cancer in post-menopausal women.
+
","Hormonal Chemotherapy
","Anastrazole exerts its anti-estrogenic effects via selective and competitive inhibition of the aromatase enzyme found predominantly in the adrenal glands, liver, and fatty tissues. Many breast cancers are hormone receptor-positive, meaning their growth is stimulated and/or maintained by the presence of hormones such as estrogen or progesterone. In postmenopausal women, estrogen is primarily derived from the conversion of adrenally-produced androgens into estrogens by the aromatase enzyme- by competitively inhibiting the biosynthesis of estrogen at these enzymes, anastrozole effectively suppresses circulating estrogen levels and, subsequently, the growth of hormone receptor-positive tumours.
","Adults Including the Elderly: One tablet (1 mg) to be taken orally once a day.
Children: The use of Anastrozole is not recommended in children, as efficacy has not been established
Renal Impairment: No dose change is recommended.
Hepatic Impairment: No dose change is recommended.
",,"Tamoxifen and/or other therapies containing estrogen should not be co-administered with Anastrozole.
",,"Very common side effects: Hot flushes, asthenia, joint stiffness, arthritis, headache, nausea, rash etc. Common side effects: Hair thinning, allergic reactions, diarrhea, vomiting, somnolence etc.
","Anastrozole must not be administered during pregnancy or lactation.
","Anastrozole is not recommended for use in children or in pre-menopausal women as safety and efficacy have not been established in these groups of patients.
+
+- Anastrozole has not been investigated in patients with severe hepatic or severe renal impairment. The potential risk/benefit to such patients should be carefully considered before administration of Anastrozole.
+- As Anastrozole lowers circulating estrogen levels, it may cause a reduction in bone mineral density with a possible consequent increased risk of fracture.
+
",,"There is limited clinical experience of overdose of Anastrozole. There are no reports where a patient has taken a dose in excess of 60 mg. No toxicity was observed and no clinically relevant adverse effects have been seen.
",,,"Store in a cool & dry place, protected from light and moisture. Keep out of reach of children.
",10
+71,Ampicillin Sodium,ampicillin-sodium-71,https://medex.com.bd/attachments/Fpptyb2lTEnNl96HJYw2sj6ksgooHU/ampicillin-sodium-oral-suspension-and-capsule-prescribing-information,,,"Ampicillin is indicated in the treatment of infections caused by susceptible strains of the designated organism listed below:
+
+- Infections of the Genitourinary Tract Including Gonorrhea: E. coli, P. mirabilis, enterococci, Shigella, S. typhosa and other Salmonella, and nonpenicillinase-producing N. gononhoeae.
... Read more
Ampicillin is indicated in the treatment of infections caused by susceptible strains of the designated organism listed below:
+
+- Infections of the Genitourinary Tract Including Gonorrhea: E. coli, P. mirabilis, enterococci, Shigella, S. typhosa and other Salmonella, and nonpenicillinase-producing N. gononhoeae.
+- Infections of the Respiratory Tract: Nonpenicillinase-producing H. influenzae and staphylococci, and streptococci including streptococcus pneumoniae.
+- Infections of the Gastrointestinal Tract: Shigella, S. typhosa and other Salmonella, E. coli, P. mirabilis, and enterococci.
+- Meningitis: O. Meningitides.
+
+Bacteriology studies to determine the causative organisms and their sensetivity to ampicillin should be performed. Therapy may be instituted prior to the results of susceptibility testing.
",,"Ampicillin inhibits bacterial cell wall synthesis by binding to 1 or more of the penicillin-binding proteins (PBPs) which in turn inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.
","Intra-articular:Supplement in systemic therapy for treatment of susceptible infections-
+
+- Adult: 500 mg daily.
+- Child: <10 yr Half of adult routine dosage.
+
+
Intraperitoneal:Supplement in systemic therapy for treatment of susceptible infections-
+
+- Adult: 500 mg daily.
+- Child: <10 yr Half of adult routine dosage.
+
+
Intrapleural:Supplement in systemic therapy for treatment of susceptible infections-
+
+- Adult: 500 mg daily.
+- Child: <10 yr Half of adult routine dosage
+
+
Intravenous:Meningitis-
+
+- Adult: 2 gm 6 hrly.
+- Child: 150 mg/kg daily in divided doses.
+
+Intrapartum prophylaxis against group B Streptoccocal infection in neonates-
+
+- Adult: Initially, 2 gm via IV inj followed by 1 gm 4 hrly until delivery.
+
+
Oral:Biliary tract infections, Bronchitis, Endocarditis, Gastroenteritis, Listeriosis, Otitis media, Perinatal streptococcal infections, Peritonitis-
+
+- Adult: 0.25-1 gm 6 hrly.
+- Child: <10 yr Half of adult routine dosage.
+
+Typhoid and paratyphoid fever-
+
+- Adult: 1-2 gm 6 hrly for 2 wk in acute infections, and 4-12 wk in carriers.
+
+Uncomplicated gonorrhoea-
+
+- Adult: 2 gm with 1 gm of probenecid as single dose, recommended to be repeated in female patients.
+
+Urinary tract infections-
+
+
Parenteral:Susceptible infections-
+
+- Adult: 500 mg 6 hrly, via IM or slow IV inj over 3-5 min or by infusion.
+- Child: <10 yr Half of adult routine dosage.
+
+Septicaemia-
+
+- Adult: 150-200 mg/kg daily. Initiate with IV admin for at least 3 days, then continue with IM inj 3-4 hrly. Continue treatment for at least 48-72 hr after the patient has become asymptomatic or when there is evidence of bacterial eradication. Recommended treatment duration for infections caused by group-A β-haemolytic streptococci: At least 10-days, to prevent occurrence of acute rheumatic fever or acute glomerulonephritis.
+- Child: Same as adult dose.
+
","Should be taken on an empty stomach. Take 1 hr before or 2 hr after meals.
","May reduce the efficacy of oral contraceptives. May alter INR while on warfarin and phenindione. May reduce the efficacy of oral typhoid vaccines. May reduce the excretion of methotrexate. Reduced excretion with probenecid and sulfinpyrazone, resulting to increased risk of toxicity. Allopurinol increases ampicillin-induced skin reactions. Reduced absorption with chloroquine. Bacteriostatic antibacterials (e.g. erythromycin, chloramphenicol, tetracycline) may interfere with the bactericidal action of ampicillin.
","Hypersensitivity to ampicillin and other penicillins.
","Nausea, vomiting, diarrhoea, erythematous maculo-papular rashes, sore mouth, black/hairy tongue, rash, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, fever, joint pains, serum sickness-like symptoms, haemolytic anaemia, thrombocytopenia, leucopenia, neutropenia, coagulation disorders, prolonged bleeding time and prothrombin time, CNS toxicity (e.g. convulsions); paraesthesia, nephropathy, interstitial nephritis, hepatitis, cholestatic jaundice, moderate and transient increase in transaminases, Anaphylaxis, Clostridium difficile-associated diarrhoea (CDAD).
","Pregnancy Category B. Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
","Patient with history of β-lactam allergy. During renal impairment, Pregnancy and lactation.
","Renal Impairment: CrCl<10: Dose reduction or increase in dose interval.
","Symptoms: Nausea, vomiting and diarrhoea.
Management: Symptomatic and supportive treatment. May be removed from the circulation by haemodialysis.
",,"Intramuscular: Add 1.5 mL water for inj to 500 mg vial contents.
Intravenous: Dissolve 500 mg in 10 mL water for inj. May be added to infusion fluids or injected, suitably diluted into the drip tube.
Intra-articular: Dissolve 500 mg in up to 5 mL of water for inj or sterile procaine HCl 0.5% soln.
Intraperitoneal: Dissolve 500 mg in up to 10 mL water for inj.
Intrapleural: Dissolve 500 mg in 5-10 mL water for inj.
","Store between 20-25° C. Reconstituted oral susp: Store between 2-8° C (discard after 14 days).
",13
+1239,Amphotericin B,amphotericin-b-1239,https://medex.com.bd/attachments/8OVVG8HGIgVyeIrzwOKy6nP2L4xOAj/amphotericin-b-prescribing-information,Other Antifungal preparations,Visceral leishmaniasis,"Amphotericin B is indicated for the following:
+
+- Empirical therapy for presumed fungal infection in febrile, neutropenic patients.
+- Treatment of Cryptococcal Meningitis in HIV infected patients
+- Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate.
... Read more
Amphotericin B is indicated for the following:
+
+- Empirical therapy for presumed fungal infection in febrile, neutropenic patients.
+- Treatment of Cryptococcal Meningitis in HIV infected patients
+- Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate.
+- Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with Amphotericin B, relapse rates were high following initial clearance of parasites
+
","Other Antifungal preparations
","Amphotericin B is fungistatic or fungicidal depending on the concentration obtained in body fluids and the susceptibility of the fungus. The drug acts by binding to sterols (ergosterol) in the cell membrane of susceptible fungi. This creates a transmembrane channel, and the resultant change in membrane permeability allowing leakage of intracellular components. Ergosterol, the principal sterol in the fungal cytoplasmic membrane, is the target site of action of amphotericin B and the azoles. Amphotericin B, a polyene, binds irreversibly to ergosterol, resulting in disruption of membrane integrity and ultimately cell death.
","Systemic Fungal Infections-
+
+- Test dose: 1 mg IV infused over 20-30 min
+- Load: 0.25-0.5 mg/kg IV infused over 2-6 hour
+- Maintenance: 0.25-1 mg/kg IV qDay OR up to 1.5 mg/kg IV every other day (may increase gradually by 0.25 mg-increments/day)
+
",,"Increased toxicity with flucytosine. Drug induced renal toxicity enhanced in presence of other nephrotoxic medications. Antagonises effects of azole antifungals.
","Amphotericin B is contraindicated in those patients who have demonstrated or have known hypersensitivity to amphotericin B deoxycholate or any other constituents of the product unless, in the opinion of the treating physician, the benefit of therapy outweighs the risk.
","Common side effects are Fever, chills, convulsions, malaise; nausea, vomiting, diarrhoea, anorexia; tinnitus, vertigo, hearing loss; hypotension, hypertension, cardiac arrhythmias; peripheral neuropathy; phloebitis, pain at Inj site, disturbances in renal function and renal toxicity.
","Pregnancy Category B. There have been no adequate and well-controlled studies of Amphotericin B in pregnant women. It is not known whether Amphotericin B is excreted in human milk.
","As with any amphotericin B-containing product the drug should be administered by medically trained personnel. During the initial dosing period, patients should be under close clinical observation. amphotericin B has been shown to be significantly less toxic than amphotericin B deoxycholate; however, adverse events may still occur.
",,,,"Aseptically add 12 mL of Sterile Water for Injection, to each Amphotericin B vial to yield a preparation containing 4 mg amphotericin B/mL. Immediately after the addition of water, shake the vial vigorously for 30 seconds to completely disperse the Amphotericin B. This forms a yellow, translucent suspension. Visually inspect the vial for particulate matter and continue shaking until completely dispersed.
","Unopened vials of lyophilized material are to be stored at temperatures up to 25°C. The reconstituted product concentrate may be stored for up to 24 hours at 2-8° C.
",11
+186,Calcium Orotate,calcium-orotate-186,,Minerals in bone formation,Calcium suppliment,"This medication is used to prevent or treat low blood calcium levels in people who do not get enough calcium from their diets. To fulfill the calcium deficiency or meet extra need of calcium, it may be used in conditions like osteoporosis osteomalacia, rickets, latent tetany, postmenopausal osteoporosis ... Read more
This medication is used to prevent or treat low blood calcium levels in people who do not get enough calcium from their diets. To fulfill the calcium deficiency or meet extra need of calcium, it may be used in conditions like osteoporosis osteomalacia, rickets, latent tetany, postmenopausal osteoporosis, senile osteoporosis, juvenile osteoporosis, drug (phenytoin, phenobarbital, or prednisone) induced osteoporosis, pregnancy and lactation, premenstrual syndrome (PMS), hypoparathyroidism and hip joint plastic surgery.
Calcium Orotate acts against a number of inflammatory diseases like arthritis, psoriasis, lupus, spondylitis, various cardiovascular ailments, encephalitis, retinitis, phlebitis, colitis, and multiple sclerosis. Calcium Orotate helps in controlling weight by suppressing the habit of frequent appetite of chronic overeaters. It is also beneficial in reducing the effects of mood swings and is proved to be quite effective in cognitive enhancement. Calcium Orotate protects the heart by enhancing the efficiency of cardiac muscles. Recent studies on calcium orotate indicate its potential to minimize the risk of colon cancer.
","Minerals in bone formation, Specific mineral preparations
","This contains Calcium Orotate, a calcium supplement with a functional amino acid chelating ligand- orotic acid. Orotic acid assists the transport of calcium through cellular membrane structures, thus facilitating the intracellular uptake of calcium, particularly in bone. Calcium Orotate also helps in the maintenance of healthy cartilage. Furthermore, Orotate is involved in the synthesis of DNA (deoxyribonucleic acid) and RNA (ribonucleic acid) of the various calcium supplements on the market, Calcium Orotate gets high marks because of the compound's ability to penetrate complex cell membranes so that it can be metabolized in cartilage.
","Calcium Orotate 400 mg: As an addition to the daily diet, 2-3 tablets are usually recommended with meal or as directed by a physician.
Calcium Orotate 740 mg: As an addition to the daily diet, 1-2 tablets are usually recommended with meal or as directed by a physician.
",,"Calcium can decrease absorption of the following drugs when taken together: biphosphonates (e.g., alendronate), quinolone antibiotics (e.g., ciprofloxacin, levofloxacin), and tetracycline antibiotics (e.g., doxycycline, minocycline), levothyroxine, phenytoin (an anticonvulsant), and tiludronate disodium (to treat Paget's disease). Thiazide-type diuretics can interact with Calcium supplements, increasing the risks of hypercalcemia and hypercalciuria. Both aluminum- and magnesium-containing antacids increase urinary calcium excretion. Mineral oil and stimulant laxatives decrease calcium absorption. Glucocorticoids, such as prednisone, can cause calcium depletion and eventually osteoporosis when they are used for months. Oral contraceptives as well as estrogen compounds reduce calcium. Anti-inflammatories such as NSAIDs, Aspirin, Ibuprofen deplete calcium. Corticosteroids deplete calcium.
","Calcium Orotate is contraindicated in conditions like incomplete or infrequent bowel movements, kidney stone, kidney disease, increased activity of the parathyroid gland, high amount of Calcium in urine, high amount of Calcium in the blood, extreme loss of body water.
","Bloating and swelling in the abdomen are common side effects of Calcium Orotate. Loss of appetite, upset stomach, constipation, nausea, vomiting, unusual weight loss, increased thirst/urination, weakness, unusual tiredness, formation of kidney stones may occur infrequently.
","Women who are pregnant and breast-feeding need more calcium. Pregnancy related high blood pressure is a common and serious risk for women and their babies, and taking supplemental forms of Calcium Orotate can help to reduce this risk.
","Before taking Calcium Orotate, precaution is needed if the patient is allergic to Calcium Orotate. This drug may contain inactive ingredients, which can cause allergic reactions or other problems. Precaution is needed before using this drug in kidney disease, kidney stones, little or no stomach acid (achlorhydria), heart disease, disease of the pancreas, sarcoidosis difficulty absorbing nutrition from food (malabsorption syndrome).
",,,,,"Keep out of the reach of children. Keep in a cool & dry place. Protect from light.
",10
+2044,Calcium Lactate Gluconate + Coral Calcium + Vitamin C + Vitamin D3,calcium-lactate-gluconate-coral-calcium-vitamin-c-vitamin-d3-2044,,Specific mineral & vitamin combined preparations,Osteoporosis,"This combination is indicated for-
+
+- As an adjunct to specific therapy for osteoporosis
+- Increased demand for Calcium, Vitamin-C and Vitamin-D such as pregnancy, lactation, period of rapid growing (in childhood, addoloscence) and in old age
+- In osteomalacia
+- The prevention and treatment of Calcium deficiency/ Vitamin-D deficiency especially in the housebound and hospitalized elderly subjects
... Read more
This combination is indicated for-
+
+- As an adjunct to specific therapy for osteoporosis
+- Increased demand for Calcium, Vitamin-C and Vitamin-D such as pregnancy, lactation, period of rapid growing (in childhood, addoloscence) and in old age
+- In osteomalacia
+- The prevention and treatment of Calcium deficiency/ Vitamin-D deficiency especially in the housebound and hospitalized elderly subjects
+- As adjuvant in cold and influenza
+- Postmenopausal syndromes
+- Premenstrual symptoms
+- In high body temperatures
+- As alkalizing agent in conditions with systemic acidosis.
+
","Specific mineral & vitamin combined preparations
","Calcium Gluconate is the gluconate salt of calcium. An element or mineral necessary for normal nerve, muscle, and cardiac function, calcium as the gluconate salt helps to maintain calcium balance and prevent bone loss when taken orally. This agent may also be chemopreventive for colon and other cancers.
The Calcium Carbonate from Coral has a chemical structure that is very similar to the composition of human bone. Coral Calcium is similar to other sources but ensures better absorption. Vitamin D3 aids in the absorption of Calcium from GI tract and helps to maintain Calcium balance in the body. Calcium is used as a pharmacological agent in humans almost entirely to remedy the deficiency. Adequate calcium in the blood is so vital to a wide variety of bodily functions that our internal biochemistry will not tolerate a deficiency even for short periods.
Vitamin C is an essential component of the diet as humans cannot synthesize Vitamin C. It is a very powerful reducing agent and plays an important part in the response of the body to stress. It is important in the defense against infections.
Vitamin D is also essential for healthy bones as it aids in calcium absorption from the GI tract. In addition to this it stimulates bone formation. Clinical studies show that calcium and vitamin D has synergistic effects on bone growth as well as in osteoporosis and fracture prevention.
","Adolescents & Adults: 1 effervescent tablet per day.
Children: ½ effervescent tablet per day.
Dissolve one tablet in a glass of water.
",,,,,,,,,,,"Keep away from the reach of children. Store in a cool (below 25°C) & dry place protected from light. Keep the cap tightly closed. To be taken & sold only on the prescription of a registered physician.
",5
+1201,Calcium Lactate Gluconate + Calcium Carbonate + Vitamin D3,calcium-lactate-gluconate-calcium-carbonate-vitamin-d3-1201,https://medex.com.bd/attachments/MuQpFBgHAXzmeeCDSftB0B90wbFRfT/calcium-lactate-gluconate-calcium-carbonate-vitamin-d3-prescribing-information,Specific mineral & vitamin combined preparations,Osteoporosis,"Prevention and treatment of calcium and vitamin D deficiency. Calcium and vitamin D supplement as an adjunct to specific therapy in the prevention and treatment of Osteoporosis for patients who are at risk of calcium and vitamin D deficiency
","Specific mineral & vitamin combined preparations
","Adequate Calcium in the blood is so vital to a wide variety of bodily functions that our internal biochemistry will not tolerate a deficiency even for short periods. Clinical evidence suggests that Calcium is useful for the prevention and treatment of Osteoporosis and associated fractures. Vitamin D is also essential for healthy bones as it aids in Calcium absorption from the GI tract. In addition to this it stimulates bone formation. Clinical studies also show that Calcium and Vitamin D has synergistic effects on bone growth as well as in Osteoporosis and fracture prevention.
","1-2 tablets per day, preferably one tablet each morning and evening or as directed by the physician
","Pour a tablet in a glass of water. The tablet will be dissolved within 1-2 minutes in the water. Drink the solution immediately.
","It has possible interaction with Digoxin, Antacids containing Calcium, Aluminum or Magnesium, other Calcium supplements, Calcitriol, Tetracycline, Doxycycline, Aminocycline or Oxytetracycline etc. So while taking this suppliment with any of these drugs consultations of the physicians is needed.
","Hypercalcemia and hyperparathyroidism, Hypercalciuria and nephrolithiasis, Hypersensitivity to the component of this preparation, Severe renal insufficiencies
","Orally administered Calcium Carbonate may be irritating to the GI tract. It may also cause constipation. Hypercalcemia is rarely produced by administration of Calcium alone, but may occur when large doses are given to patients with chronic renal failure. Also there may be allergic reactions, irregular heartbeats, nausea, vomiting, decreased appetite dry mouth and drowsiness, skin rash.
","This can be used during pregnancy, in case of a calcium and vitamin D deficiency. However, for supplementation starting during the third trimester of pregnancy, the daily intake should not exceed 1500 mg calcium and 1000 IU vitamin D. This preparation can be used during breast-feeding.
","When hypercalcemia occurs discontinuation of the drug is usually sufficient to return serum calcium concentrations to normal. Calcium salts should be used cautiously in patients with sarcoidosis, renal or cardiac disease and in patients receiving cardiac glycosides. Patients with a history of stone formation should also be recommended to increase their fluid intake.
",,"Symptoms of over dose may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, Metallic taste, stomach cramps, unconsciousness, diarrhea, weakness, headache, constipation, dizziness or irritability. The most serious consequence of acute chronic overdose is hypocalcaemia due to Vitamin D toxicity
",,,"Store at a cool and dry place. Protect from light and moisture. Keep out of reach of children. Keep the container tightly closed.
",12
+175,Calcium Lactate Gluconate + Calcium Carbonate + Vitamin C + Vitamin D3,calcium-lactate-gluconate-calcium-carbonate-vitamin-c-vitamin-d3-175,,Specific mineral & vitamin combined preparations,Osteoporosis,"This combination is indicated for-
+
+- As an adjunct to specific therapy for osteoporosis
+- Increased demand for Calcium, Vitamin-C and Vitamin-D such as pregnancy, lactation, period of rapid growing (in childhood, addoloscence) and in old age
+- In osteomalacia
+- The prevention and treatment of Calcium deficiency/ Vitamin-D deficiency especially in the housebound and hospitalized elderly subjects
... Read more
This combination is indicated for-
+
+- As an adjunct to specific therapy for osteoporosis
+- Increased demand for Calcium, Vitamin-C and Vitamin-D such as pregnancy, lactation, period of rapid growing (in childhood, addoloscence) and in old age
+- In osteomalacia
+- The prevention and treatment of Calcium deficiency/ Vitamin-D deficiency especially in the housebound and hospitalized elderly subjects
+- As adjuvant in cold and influenza
+- Postmenopausal syndromes
+- Premenstrual symptoms
+- In high body temperatures
+- As alkalizing agent in conditions with systemic acidosis.
+
","Specific mineral & vitamin combined preparations
","Calcium Gluconate is the gluconate salt of calcium. An element or mineral necessary for normal nerve, muscle, and cardiac function, calcium as the gluconate salt helps to maintain calcium balance and prevent bone loss when taken orally. This agent may also be chemopreventive for colon and other cancers.
Calcium carbonate is a basic inorganic salt that acts by neutralizing hydrochloric acid in gastric secretions. It also inhibits the action of pepsin by increasing the pH and via adsorption. Cytoprotective effects may occur through increases in bicarbonate ion (HCO3-) and prostaglandins. Neutralization of hydrochloric acid results in the formation of calcium chloride, carbon dioxide and water. Approximately 90% of calcium chloride is converted to insoluble calcium salts (e.g. calcium carbonate and calcium phosphate).
Calcium is used as a pharmacological agent in humans almost entirely to remedy deficiency. Adequate calcium in the blood is so vital to a wide variety of bodily functions that our internal biochemistry will not tolerate a deficiency even for short periods.
Vitamin-C is an essential component of the diet as humans cannot synthesize Vitamin-C. It is a very powerful reducing agent and plays an important part in the response of the body to stress. It is important in the defense against infections.
Vitamin-D is also essential for healthy bones as it aids in calcium absorption from the GI tract. In addition to this it stimulates bone formation. Clinical studies show that calcium and vitamin-D has synergistic effects on bone growth as well as in osteoporosis and fracture prevention.
","Adults and children of school age: 1 effervescent tablet daily
Children 3 to 7 years: ½ effervescent tablet daily
Infants: As prescribed by the physician
Dissolve one tablet in half glass (100 ml) of water.
",,"The risk of hypercalcemia should be considered in patients taking thiazide diuretics since these drugs can reduce urinary calcium excretion. Hypercalcemia must be avoided in digitalised patients. Certain foods (e.g. those containing oxalic acid, phosphate or phytinic acid) may reduce the absorption of calcium. Concomitant therapy with phenytoin or barbiturates can decrease the effect of vitamin-D because of metabolic activation. The effect of digitalis and other cardiac glycosides may be accentuated with the oral administration of calcium combined with vitamin-D. Calcium salts may reduce the absorption of thyroxine, bisphosphonates, sodium fluoride, quinolone or tetracycline antibiotics or iron. It is advisable to allow a minimum period of 4 hours before taking the
calcium.
","Absolute contraindications are hypercalcaemia resulting from myeloma, bone metastases or other malignant bone disease, sarcoidosis; primary hyperparathyroidism and Vitamin-D overdosage. It is also contraindicated in severe renal failure and hypersensitivity to any of the tablet ingredients.
","The use of Calcium supplements has rarely given rise to mild gastrointestinal disturbances, such as constipation, flatulence, nausea, gastric pain and diarrhoea. Following administration of Vitamin-D supplements occasional skin rash has been reported. Hypercalciuria, and in rare cases hypercalcaemia have been seen in long-term treatment with Vitamin-D at high doses.
","During pregnancy and lactation treatment with this supplements should always be under the direction of a physician.
During pregnancy and lactation, requirements for calcium and vitamin-D are increased but in deciding on the required supplementation allowances should be made for availability of these agents from other sources.
Overdoses of vitamin-D have shown teratogenic effects in pregnant animals. Vitamin-D and its metabolites pass into the breast milk.
","Patients with mild to moderate renal failure or mild hypercalciuria should be supervised carefully. Periodic checks of plasma Calcium levels and urinary Calcium excretion should be made in patients with mild to moderate renal failure or mild hypercalciuria. In patients with a history of renal stones urinary Calcium excretion should be measured to exclude hypercalciuria. With long-term treatment it is advisable to monitor serum and urinary Calcium levels and kidney function, and reduce or stop treatment temporarily if urinary Calcium exceeds 7.5 mmol/24 hours. Allowances should be made for Calcium and Vitamin-D supplements from other sources.
",,"The most serious consequence of acute or chronic overdose is hypercalcaemia due to Vitamin-D toxicity. Symptoms include nausea, vomiting, polyuria, and constipation. Chronic overdoses can lead to vascular and organ calcification as a result of hypercalcaemia. Treatment should consist of stopping all intakes of calcium and Vitamin-D and rehydration.
",,,"Store at a cool and dry place. Protect from light and moisture. Keep out of reach of children. Keep the container tightly closed.
",11
+174,Calcium Lactate Gluconate + Calcium Carbonate + Vitamin C,calcium-lactate-gluconate-calcium-carbonate-vitamin-c-174,,Specific mineral & vitamin combined preparations,Premenstrual syndrome,"This is indicated in-
+
+- Increased demand for Calcium and Vitamin-C, e.g. pregnancy, lactation, periods of rapid growth (childhood, adolescence), in old age
+- During infectious disease and convalescence
+- Treatment of calcium and vitamin-C deficiency
+- Osteoporosis
+- Premenstrual syndrome
+- Postmenopausal problems
+- Adjuvant in colds and influenza.
+
","Specific mineral & vitamin combined preparations
","Calcium is used as a pharmacological agent in humans almost entirely to remedy deficiency. Adequate calcium in the blood is so vital to a wide variety of bodily functions that our internal biochemistry will not tolerate a deficiency even for short periods.
Vitamin-C is an essential component of the diet as man can not synthesize vitamin-C. It is a very powerful reducing agent. Vitamin-C plays an important part in the response of the body to stress. It is important in the defense against infection.
","Adults and children above 7 years: 1 effervescent tablet daily
Children 3 to 7 years: ½ effervescent tablet daily
Infants: As prescribed by the physician
Dissolve one tablet in half glass (100 ml) of water.
",,"Calcium Gluconate: Co-admin of high calcium doses with thiazide diuretics may result in milk-alkali syndrome and hypercalcaemia. May potentiate digoxin toxicity. Decreases effects of calcium channel blockers. Enhanced absorption with calcitriol (a vitamin D metabolite).
Calcium Carbonate: Co-administration with thiazide diuretics or vit D may lead to milk-alkali syndrome and hypercalcaemia. Decreased absorption with corticosteroids. Decreases absorption of tetracyclines, atenolol, iron, quinolones, alendronate, Na fluoride, Zn and calcium-channel blockers. Enhances cardiac effects of digitalis glycosides and may precipitate digitalis intoxication.
Vitamin C: Deferroxamine, hormonal contraceptives, flufenazine, warfarin, elemental iron, salicylates, warfarin, fluphenazine, disulfiram, mexiletine, vitamin B12.
","Hypercalcemia (e.g. in hyperparathyroidism, vitamin-D overdosage, decalcifying tumors such as plasmocytoma, bone metastases); severe hypercalciuria; severe renal failure.
Patients with hyperoxalauria, glucose-6- phosphate dehydrogenase deficiency, or iron overload. Larger doses may lead to gastrointestinal tract upset.
","In rare cases, mild gastrointestinal disturbances (bloating, diarrhoea) can occur. In predisposed patients prolonged treatment with high doses may promote the formation of calculi in the urinary tract.
","Calcium containing drugs have been widely used in pregnancy by way of oral calcium supplementation or antacid therapy. Calcium Carbonate can be safely used inlactating women. Vitamin-C may be taken safely during pregnancy and lactation
","For patients with mild hypercalciuria (exceeding 300 mg = 7.5 mmol/24 hours), with mild or moderate impairment of renal function or with a history of urinary concrements, monitoring of calcium excretion in the urine is required. If necessary, the dosage should be reduced or therapy should be discontinued. High doses of vitamin-D and derivatives should be avoided during treatment with this preparation unless especially indicated.
Since citrate salts have been reported to increase aluminium absorption, this medicine should be used with caution in patients with severely impaired renal function, especially those receiving aluminium-containing preparations. The sugar content should be taken into account by diabetic patients.
",,"Acute overdosage has not been reported. It would be expected to cause gastrointestinal disturbances but not to result in hypercalcemia, except in patients treated with a very high dosage of vitamin-D and derivatives.
",,,"Store at a cool and dry place and protected from light and moisture.
",11
+185,Calcium Lactate,calcium-lactate-185,https://medex.com.bd/attachments/YYrmTFKn8DHCjE7OCtCdXNT1W1XFPz/calcium-lactate-prescribing-information,Minerals in bone formation,Heartburn,"Calcium Lactate is indicated for heartburn, calcium supplement, calcium deficiencies.
","Minerals in bone formation, Specific mineral preparations
","Calcium is used to prevent or treat negative calcium balance. It also helps facilitate nerve and muscle performance as well as normal cardiac function. Bone mineral component; cofoactor in enzymatic reactions, essential for neurotransmission, muscle contraction, and many signal transduction pathways.
","19-50 year: 1,000 mg elemental Calcium Lactate per day.
>50 year: 1,200 mg elemental Calcium Lactate per day.
",,"May reduce the efficacy of calcium-channel blockers. Concurrent admin of IV calcium salt with cardiac glycosides may lead to serious adverse events. Increased risk of hypercalcaemia when used with thiazide diuretics. May reduce absorption of tetracycline, alendronate, atenolol, iron, quinolone antibiotics, sodium fluoride and zinc.
","Conditions associated with hypercalcaemia and hypercalciuria.
","Gl discomfort e.g. nausea, vomiting, constipation; bradycardia, arrhythmias. Dry mouth, increased thirst or increased urination. Mental confusion, milk-alkali syndrome.
","Pregnancy Category-C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","Sarcoidosis; history of nephrolithiasis. Avoid IV admin of calcium in patients on cardiac glycosides. Increased risk of hypercalcaemia and hypercalciuria in hypoparathyroid patients receiving high doses of vitamin D. Caution when used in patients with history of kidney stones. Patients should be advised to administer vitamin D concurrently to optimise calcium absorption. Pregnancy.
",,,,,,9
+182,Calcium Gluconate,calcium-gluconate-182,https://medex.com.bd/attachments/w8wPFuMjxX0osipA35IPQ9h6Pr25lQ/calcium-gluconate-prescribing-information,Minerals in bone formation,Rickets,"Calcium Gluconate is indicated for Antidote in severe hypermagnesaemia, Severe hyperkalaemia, Hypocalcaemic tetany, Severe acute hypocalcaemia, Hypocalcaemia and calcium deficiency states
","Minerals in bone formation, Specific mineral preparations
","Calcium gluconate is used to prevent or treat negative calcium balance. It also helps facilitate nerve and muscle performance as well as normal cardiac function.
","Intravenous: Antidote in severe hypermagnesaemia, Severe hyperkalaemia:
+
+- Adult: 10 ml of 10% calcium gluconate solution over 2 minutes, repeated every 10 minutes if needed.
+- Child: Neonate and 1 mth-18 yr: 0.5 ml/kg of 10% calcium gluconate solution as a single dose. Max: 20 ml of 10% calcium gluconate solution.
+
+
Intravenous: Hypocalcaemic tetany, Severe acute hypocalcaemia:
+
+- Adult: 2.25 mmol by slow IV inj over 10 minutes, followed by 58-77 ml of 10% calcium gluconate solution in 0.5-1 L of 5% dextrose solution as continuous IV infusion.
+- Child: Neonate and 1 mth-18 yr: 0.5 ml/kg of 10% calcium gluconate solution as a single dose. Max: 20 ml of 10% calcium gluconate solution.
+
",,"Co-administration of high calcium doses with thiazide diuretics may result in milk-alkali syndrome and hypercalcaemia. May potentiate digoxin toxicity. Decreases effects of calcium-channel blockers. Enhanced absorption with calcitriol (a vitamin D metabolite).
","Patients with calcium renal calculi or history of renal calculi. Conditions associated with hypercalcaemia and hypercalciuria.
","GI irritation; soft-tissue calcification, skin sloughing or necrosis after IM/SC inj. Hypercalcaemia characterised by anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, mental disturbances, polydipsia, polyuria, nephrocalcinosis, renal calculi; chalky taste, hot flushes and peripheral vasodilation.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
","Impaired renal function; cardiac disease; hypercalcaemia-associated diseases, e.g. sarcoidosis; other malignancies. Pregnancy.
",,,,,,9
+499,Calcium Folinate [Folinic Acid],calcium-folinate-folinic-acid-499,https://medex.com.bd/attachments/y5Xs886fWHEpOT0mhRiHnJvukPIHzD/calcium-folinate-folinic-acid-tablets-prescribing-information,Supportive Care Therapy,Methotrexate toxicity,"Calcium Folinate is indicated in:
+
+- To diminish the toxicity and counteract the effect of impaired Methotrexate elimination.
+- To treat the Megaloblastic anemia due to folate deficiency, as in sprue, nutritional deficiency.
+- To treat the Megaloblastic anemia of pregnancy and infancy.
+
","Supportive Care Therapy
","Calcium Folinate is a Calcium salt of Folinic acid (citrovorum factor), is a mixture of the diastereoisomers of the 5-formyl derivative of Tetrahydrofolic acid. It is a metabolite of Folic acid and an essential co-enzyme for nucleic acid synthesis used in cytotoxic therapy.
","Oral-
+
+- Reduction of harmful effects of folic acid antagonists: The dose is usually one 5-15 mg tablet every 6 hours for 2 to 3 days.
+- Megaloblastic anemia: In the treatment of Megaloblastic anemia, the dose is one 5-15 mg tablet daily.
+
+Intravenous-
+
+- Advanced Colorectal Cancer: Folinic Acid is administered at 200 mg/m2 by slow intravenous injection followed by 5-fluorouracil at 370 mg/m2 by intravenous injection. Or 20 mg/m 2 by slow intravenous injection followed by 5-fluorouracil at 425 mg/m2 by intravenous injection. Treatment is repeated daily for 5 days. This 5 day treatment course may be repeated at 4 weeks interval, for 2 courses and then may repeated at 4-5 weekly intervals if the patient has recovered completely from the toxic effects of the prior treatment course.
+- Folinic acid rescue after high dose Methotrexate Therapy: Calcium Folinate starts 24 hours after the beginning of the methotrexate infusion at dose of 15mg (10 mg/m2 ) every 6 hours for 10 doses.
+
+Intramuscular-
+
+- Folate deficient megaloboastic anaemia: Up to 1 mg/day. Or, as directed by the registered physician.
+
",,,"Calcium Folinate therapy is contraindicated for the following:
+
+- Known hypersensitivity to Calcium Folinate, or to any components of the product formulation.
+- Pernicious anemia or other Megaloblastic anemia where Vitamin B12 is deficient.
+
","
+- Allergic reaction: one may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing).
+- Fits and fainting.
+
","There are no adequate and well-controlled clinical studies conducted in pregnant or breastfeeding women. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Calcium Folinate is administered to a nursing mother.
","Calcium Folinate treatment may mask pernicious anemia and other Megaloblastic anemia resulting from Vitamin B12 deficiency.
Calcium Folinate should only be used with 5-fluorouracil or Methotrexate under the direct supervision of a clinician experienced in the use of cancer chemotherapeutic agents.
Many cytotoxic medicinal products- direct or indirect DNA synthesis inhibitors- lead to macrocytosis (hydroxycarbamide, cytarabine, mercaptopurine, thioguanine). Such macrocytosis should not be treated with Folinic acid.
In epileptic patients treated with Phenobarbital, Phenytoin, Primidone, and Succinimides, there is a risk to increase the frequency of seizures due to a decrease of plasma concentrations of anti-epileptic drug.
",,"There have been no reported sequelae in patients who have received significantly more Calcium Folinate than the recommended dosage. However, excessive amounts of Calcium Folinate may nullify the chemotherapeutic effect of folic acid antagonists.
",,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",10
+1459,Calcium Dobesilate + Lidocaine + Dexamethasone,calcium-dobesilate-lidocaine-dexamethasone-1459,https://medex.com.bd/attachments/7QT6V0bmhnGSqbHki7YJiPJhG8r0Ol/calcium-dobesilate-lidocaine-dexamethasone-prescribing-information,Drugs used in Ano-rectal region,Soreness and discomfort due to hemorrhoids,"This rectal ointment is indicated in-
+
+- Internal and external hemorrhoids,
+- Anal pruritus
+- Anal eczema
+- Anitis
+- Perianitis
+- Acute hemorrhoidal thrombosis
+- Anal fissure
+- Pre and postoperative treatment in cases of hemorrhoidectomy
+
+A long-lasting treatment is not indicated.
","Drugs used in Ano-rectal region
","Calcium Dobesilate acts on the capillary walls by regulating their impaired physiological functions- i.e. increased permeability and decreased resistance and on different signs of inflammation. It also has an antithrombotic activity. Lidocaine hydrochloride, a local anesthetic, contributes to relieve pain. Dexamethasone Acetate, a Corticosteroid for topical use, possesses anti-inflammatory and antipruritic actions.
","2-3 times daily. Apply in the morning and bedtime and if possible after defecation. If the ointment is preferred, use the applicator by screwing it to the tube. Insert the applicator as deep as possible in the anus then press the tube gently while withdrawing it. In this case, the tube is sufficient for 8 applications. In case of external hemorrhoids or anal pruritus, apply a thin layer of the ointment several times a day. The duration of the treatment is generally of some days. The doctor must be informed if, after 1 to 2 weeks of treatment, the symptomatology has not improved or has worsened.
Calcium Dobesilate, Lidocaine HCI & Dexamethasone Acetate Ointment should be applied 2-3 times daily preferably in the morning and at bedtime, if possible apply after defecation. In the case of internal hemorrhoids apply the ointment by the applicator. In cases of external hemorrhoids and anal pruritus, apply a thin layer of the ointment several times a day. The duration of the treatment is generally of some days. The physician must be informed if, after 1 to 2 weeks of treatment the symptomatology has not improved or has worsened.
Method of use of this ointment:
For internal use-
+
+- Before use remove the cap from the tube.
+- Pierce the tube membrane by inverting the cap.
+- Attach the applicator (supplied) to the tube.
+- Squeeze the tube to fill the applicator and lubricate the tip with ointment for smooth insertion.
+- Insert the applicator gently and to full extend into the anus and squeeze once again from the end of the tube to force the required amount of ointment into the anal canal.
+- Remove the applicator after application and discard it.
+- Try not to have defecation for a couple of hours after an internal application.
+
+
For external use-
+
+- Squeeze the tube of ointment and apply a small amount to the finger.
+- Apply the ointment around the outside of the anus with a finger.
+- Wash the hands thoroughly with warm water and soap after each application.
+- Reattach the cap to tube.
+
",,,"Hypersensitivity towards the components of this preparation.
","Very rare cases have been reported: Modifications of the intestinal transit, temporary burning sensation and local pain. Hypersensitivity reactions together with skin reactions and/or fever can occur. These reactions can be of allergic origin and in this case, the treatment must be discontinued.
","Pregnancy category C. Studies in pregnant women or animals are not available and in humans, it is not known whether Calcium Dobesilate crosses the placental barrier. On the other hand, after topical administration, Lidocaine Hydrochloride and Dexamethasone Acetate are resorbed in variable quantities and can have systemic effects. Moreover, both substances cross the placental barrier. In these conditions, this rectal ointment should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. After oral administration, Calcium Dobesilate is excreted in the maternal milk in low amounts but it is not known whether this is the case with local use. After topical administration, Lidocaine Hydrochloride and Dexamethasone Acetate are excreted in the maternal milk. As a precaution, it should be decided between discontinuating the treatment or the breast-feeding.
","In case of renal insufficiency, this rectal ointment should not be used during longer periods. Avoid long-lasting treatments.
",,"No overdosage information found yet.
",,,"The ointment must be stored protected from heat. Store it below 30°C.
",10
+1438,Calcium Dobesilate,calcium-dobesilate-1438,,Vaso Protective,,"Calcium Dobesilate is indicated for the treatment of hemorrhoidal syndrome, microcirculation disorders of arteovenous origin, clinical signs of chronic venous insufficiency in the lower limbs (pain, cramps, paresthesia, edema, stasis, dermotosis) and in the particular microangiopathy like diabetic retinopathy. It is also indicated in superficial thrombophlebitis as adjuvant therapy.
","Vaso Protective
","Calcium dobesilate acts selectively on the capillary walls regulating their physiological functions of resistance and permeability. It lowers blood viscosity and restores normal blood flow. This action is beneficial in all cases of capillary fragility due to metabolic disturbances (constitutional or acquired), and surgical stress or induced by certain medicines.
","Calcium Dobesilate capsule once or twice daily should be taken with the main meal. Treatment duration, which generally between a few weeks to several months, depends on the disease and its evolution. Dosage should be adapted individually according to the severity of the disease.
",,,"Hypersensitivity. Pregnancy and lactation.
","Rarely gastrointestinal disorders including nausea and diarrhea, skin reactions, fever, articular pain and in very rare cases agranulocytosis have been reported. These reactions are generally spontaneously reversible after treatment withdrawal.
","The safety of Calcium Dobesilate during pregnancy and lactation has not been established. As it is not known whether calcium dobesilate crosses the placental barrier in humans, the drug should be administered during pregnancy only if the benefit to the mother outweighs the potential risk to the fetus. Avoid breastfeeding while using this medicine.
","Dosage should be reduced in case of severe renal insufficiency requiring dialysis. In patient with agranulocytosis, this medication can decrease the number of white blood cells which affect the body’s ability to fight against various infections. If patients experience flu-like symptoms such as cough, sore throat, fever and others, they are advised to seek medical care as soon as possible.
",,"The clinical signs of a possible overdose are not known. If overdose occurs, seek medical advice immediately.
",,,"Store in a cool and dry place, away from light. Keep out of the reach of children.
",10
+168,Calcium Carbonate + Vitamin D3 + Multimineral,calcium-carbonate-vitamin-d3-multimineral-168,,Specific mineral & vitamin combined preparations,Vitamin deficiency,"This preparation is indicated in-
+
+- Prevention and treatment of osteoporosis
+- To maintain strong bone growth
+- For proper functioning of heart, muscle and nerves
+- As nutritional supplement
+- For bone development and regeneration of bone
+- Pregnancy & lactation
... Read more
This preparation is indicated in-
+
+- Prevention and treatment of osteoporosis
+- To maintain strong bone growth
+- For proper functioning of heart, muscle and nerves
+- As nutritional supplement
+- For bone development and regeneration of bone
+- Pregnancy & lactation
+- Deficiency state of Calcium, Vitamin D3, Magnesium, Zinc, Copper, Manganese & Boron
+
","Specific mineral & vitamin combined preparations
","Nutrition is the most important to prevent osteoporosis and other bone related diseases. Calcium, Magnesium & Vitamin D3 are the macronutrients for bone. Without Vitamin D3 very little Calcium is absorbed. Like Calcium, Magnesium increases bone strength and rigidity. Recent epidemiological studies showed that some micronutrients like Copper, Manganese, Zinc & Boron play an important role in bone health. Deficiency of the micronutrients is noticed in patients with osteoporosis.
","2 tablets per day, preferably 1 tablet in the morning and 1 tablet in the evening.
",,"It has possible interaction with Calcium, Aluminium or Magnesium containing Antacids & other Calcium supplements, Calcitriol & other Vitamin D3 supplements; Digoxin, Tetracycline, Doxycycline, Minocycline or Oxytetracycline.
","It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.
","It is generally well tolerated. If there is experience like nausea, vomiting, stomach cramps, dry mouth, increased thirst, increased urination while taking, noticed to physicians. Side effects from micronutrient are rare.
","This combination should be used as directed by physician during pregnancy or while breast-feeding.
","If there is any pre-existing heart disease or kidney disease, precautions should be taken.
",,"Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache & constipation.
",,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",11
+169,Calcium Carbonate [Elemental source] + Vitamin D3,calcium-carbonate-elemental-source-vitamin-d3-169,,Specific mineral & vitamin combined preparations,Rickets,"This combination is used for treatment of osteoporosis, osteomalacia, rickets, tetany and in parathyroid disease. Calcium supplements are often used to ensure adequate dietary intake in conditions such as pregnancy & lactation, osteogenesis and tooth formation (adjunct with definite treatment) and ... Read more
This combination is used for treatment of osteoporosis, osteomalacia, rickets, tetany and in parathyroid disease. Calcium supplements are often used to ensure adequate dietary intake in conditions such as pregnancy & lactation, osteogenesis and tooth formation (adjunct with definite treatment) and therapy with anti-seizure medications. It is also used as routine supplement and phosphate binder in chronic renal failure.
","Specific mineral & vitamin combined preparations
","This is the preparation of Calcium Carbonate and Vitamin D3 (Cholecalciferol). Calcium is necessary for many normal functions of our body, especially bone formation and maintenance. Vitamin D3 helps for the absorption & reabsorption of Calcium. Vitamin D3 also stimulates bone formation. Clinical studies showed that Calcium and Vitamin D3 all together helps in bone growth, and in prevention of osteoporosis & bone fracture.
","Calcium 500 mg and Vitamin D3 200 IU Tablet: 2 tablets daily or 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.
Calcium 500 mg and Vitamin D3 400 IU Tablet: 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.
",,"It has possible interaction with calcium, aluminium or magnesium containing antacids & other calcium supplements, calcitriol & other vitamin D3 supplements; digoxin, tetracycline, doxycycline, minocycline or oxytetracycline.
","It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.
","It is generally well tolerated. If there is experience like nausea, vomiting, stomach cramps, dry mouth, increased thirst, increased urination while taking, noticed to physicians. Constipation may occur.
","This combination should be used as directed by physician during pregnancy or while breast-feeding.
","If there is any pre-existing heart disease or kidney disease, precautions should be taken.
",,"Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache, constipation.
",,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",11
+1548,Calcium Carbonate [Eggshell Source] + Vitamin D3,calcium-carbonate-eggshell-source-vitamin-d3-1548,,Specific mineral & vitamin combined preparations,Osteoporosis,"Calcium and Vitamin D3 is used for the treatment of:
+
+- Bone loss (osteoporosis)
+- Weak bones (osteomalacia, osteopenia)
+- Rickets
+- Decreased activity of the parathyroid gland (hypoparathyroidism)
+- Latent tetany (certain muscle disease)
+
+To
... Read moreCalcium and Vitamin D3 is used for the treatment of:
+
+- Bone loss (osteoporosis)
+- Weak bones (osteomalacia, osteopenia)
+- Rickets
+- Decreased activity of the parathyroid gland (hypoparathyroidism)
+- Latent tetany (certain muscle disease)
+
+To ensure adequate Calcium and Vitamin D3, it may also be used in certain conditions such as:
+
+- Pregnancy and lactation
+- Post-menopausal osteoporosis
+- Senile osteoporosis
+- Drug like- Phenytoin, Phenobarbital or Prednisolone type drug may induce osteoporosis
+
","Specific mineral & vitamin combined preparations
","Calcium plays a very important role in the body. It is necessary for normal functioning of bone, nerve cells, muscle, and other vital organs and the regulatory system of the body. If there is not enough calcium in the blood, then the body will take Calcium from bones, thereby weakening bones and triggers different types of bone disorder. Vitamin D3 helps the body to absorb Calcium. Having the right amounts of Calcium and Vitamin D3 is important for building and keeping strong bones and healthy muscles.
","Route of Administration: Oral. One tablet in the morning and one tablet at night or as directed by the physician. Use in children and adolescents should be directed by the physician.
",,"With Medicine: It has possible interaction with digoxin, antacids containing Calcium, aluminum or magnesium, other Calcium supplements, calcitriol, tetracycline, doxycycline, aminocycline or oxytetracycline etc. So while taking Calcium tablet with any of these drugs consultations of the physicians is needed.
With food & others: The intestinal uptake of Calcium may be reduced by concomitant ingestion of certain foods (e.g. spinach, milk and milk products).
","
+- Hypercalcemia and hyperparathyroidism
+- Hypercalciuria and nephrolithiasis
+- Hypersensitivity to the component of this preparation
+- Severe renal insufficiencies
+- Concomitant digoxin therapy (requires careful monitoring of serum Calcium level
+
","Common Side Effects: Generally orally administered Calcium Carbonate may be irritating to the Gl tract and it may also cause constipation but eggshell Calcium is safe for long-term use without causing any Gl discomfort or constipation. Rare Side Effects: Kidney stone, hypercalcemia, alkalosis, loss of appetite.
","It should be used as directed by the physician during Pregnancy and Lactation.
","When hypercalcemia occurs, discontinuation of the drug is required. Patients with a history of kidney stone formation should also be recommended to increase their fluid intake.
",,"Symptoms of overdose may include nausea and vomiting, dry mouth, loss of appetite, metallic taste, diarrhea, weakness, headache, irritability or dizziness etc.
",,,"Store in a cool (below 30°C) and dry place, away from light. Keep out of the reach of children.
",11
+1200,Calcium Carbonate [Coral source] + Vitamin D3,calcium-carbonate-coral-source-vitamin-d3-1200,,Specific mineral & vitamin combined preparations,Rickets,"This is indicated for the treatment & prevention of osteoporosis, osteomalacia, tetany, hypoparathyroidism, disorders of osteogenesis. Also used as supplement in case of inadequate intake of Calcium in childhood diet, rickets, pregnancy & lactation, elderly patients. Other indications include pancreatitis, phosphate binder in chronic renal failure etc.
","Specific mineral & vitamin combined preparations
","This is a Calcium and Vitamin D3 preparation where Calcium Carbonate is sourced from coral origin. The Calcium Carbonate from Coral has a chemical structure that is very similar to the composition of human bone. Coral Calcium is similar to other sources but ensures better absorption. Vitamin D3 aids in the absorption of Calcium from GI tract and helps to maintain Calcium balance in the body.
","One tablet once or twice daily with plenty of water or as directed by the physician. Taking in full stomach ensures better absorption.
",,"Oral Calcium can reduce the absorption of tetracycline & fluoride preparations and minimum 3 hours time should be allowed between ingestion of these medications. Thiazide diuretics reduces the renal excretion of Calcium. Phenytoin, barbiturates, glucocorticoids may induce metabolism of Vitamin D3. Concomitant ingestion of certain foods like spinach, cereals, milk and its derivatives may reduce the intestinal uptake of Calcium.
","Hypersensitivity to any of the components, hypocalcaemia resulting from overdose of Vitamin D3, hyperparathyroidism, bone metastases, severe renal insufficiency, severe hypercalciuria, renal calculi etc.
","Flatulence, diarrhoea, constipation, upper GI discomfort etc. are rare manifestation. Hypercalcaemia due to prolong use has rarely been reported.
","This can be given to pregnant and lactating mothers as per recommendation of physician.
","In presence of mild hypercalciuria, careful monitoring with reduction of dose may be needed. Plasma and serum Calcium level should be monitored in mild to moderate renal impairment and also in case of long-term use. Patients with renal stones or with such previous history should also take precautions.
",,"At high doses it may result in nausea, vomiting, dizziness, anorexia, abdominal cramps, headache, constipation, irritability etc. Treatment includes cessation of therapy and adequate rehydration.
",,,"Store at temperature of below 30°C, protect from light & moisture. Keep out of reach of children.
",11
+1772,Calcium Carbonate [Algae source] + Vitamin D3,calcium-carbonate-algae-source-vitamin-d3-1772,,Specific mineral & vitamin combined preparations,Rickets,"
+- Treatment of osteoporosis, rickets, osteomalacia, tetany and hypoparathyroidism
+- In pregnancy and lactation due to increased demand
+- In kidney disease and pancreatitis
+- During therapy with antiseizure medications
+- The prevention and treatment of Calcium and Vitamin D3 deficiency
+
","Specific mineral & vitamin combined preparations
","This is combination of Calcium (Algae Source) & Vitamin D3. Calcium (Algae Source) is an essential element and plays vital role in the body. It makes body's framework stronger by building bones. Clinical evidence suggests that calcium is useful for prevention and treatment of osteoporosis and associated fractures. Vitamin D3 is also essential for healthy bones as it aids in calcium absorption from the Gl tract. In addition to this it stimulates bone formation. Controlled clinical studies show that Calcium and Vitamin D3 have synergistic effects on bone growth as well as in osteoporosis and fracture prevention.
","Usual adult dose: 1 tablet in the morning and 1 tablet at night. Tablet should be taken orally.
",,"With medicine:
+
+- Calcium salts reduce absorption of bisphosphonates, ciprofloxacin, fluorides, iron, levothyroxine, tetracycline and zinc
+- Absorption of calcium salts is reduced by corticosteroids
+- Increased risk of hypercalcemia when Calcium and Vitamin D3 given with thiazides and related diuretics
+
+With food and others: No clinically significant food drug interaction have been reported.
","
+- Hypocalcemia and hypercalciuria
+- Metastatic calcification
+- Hypersensitivity to any of the components of Calcium and Vitamin D3 preparation
+
","Common side effects of Calcium and Vitamin D3 may include an irregular heartbeat, nausea, dry mouth, weakness, headache, a metallic taste in mouth, muscle or bone pain and drowsiness. Rare side effects are high amount of Calcium in blood, constipation, diarrhoea, loss of appetite.
","During pregnancy & lactation: Calcium and Vitamin D3 should be used considering the risk-benefit ratio.
","Caution should be taken in patients with renal impairment, sarcoidosis, hypercalcemia and hypercalciuria.
","Not recommended for children under 12 years.
","At high doses it may result in nausea, vomiting, dizziness, anorexia, abdominal cramps, headache, constipation etc. Treatment includes cessation of therapy & adequate rehydration.
",,,"Store below 30°C and away from light & moisture. Keep out of the reach of children.
",12
+173,Calcium Carbonate,calcium-carbonate-173,https://medex.com.bd/attachments/4ebsX7KANYJGqyVZDosXkS5ps0IklT/calcium-carbonate-prescribing-information,Minerals in bone formation,,"250 mg or 500 mg tablet: This is used for the treatment or prevention of calcium depletion in patients in whom dietary measures are inadequate. Conditions that may be associated with calcium deficiency include hypoparathyroidism, achlorhydria, chronic diarrhea, vitamin D deficiency ... Read more
250 mg or 500 mg tablet: This is used for the treatment or prevention of calcium depletion in patients in whom dietary measures are inadequate. Conditions that may be associated with calcium deficiency include hypoparathyroidism, achlorhydria, chronic diarrhea, vitamin D deficiency, steatorrhea, sprue, pregnancy and lactation, menopause, pancreatitis, renal failure, alkalosis, and hyperphosphataemia. Calcium Carbonate is being used increasingly often to treat hyperphosphataemia in chronic renal failure as well as those on continuous ambulatory peritoneal dialysis (CAPD) and haemodialysis. Many patients are unable to tolerate sufficient doses for complete phosphate control and require additional measures such as stringent dietary phosphate restriction or relatively small doses of aluminium hydroxide. Calcium Carbonate containing preparations can provide short-term relief of dyspeptic systems but are no longer recommended for long-term treatment of peptic ulceration.
1000 mg tablet: This is indicated for the management of conditions associated with hyperidity and for fast relief of acid indigestion, heartburn, sour stomach and upset stomach.
","Minerals in bone formation, Specific mineral preparations
","Calcium carbonate reacts with gastric acid to produce a salt and water. For calcium carbonate the postulated chemical reaction is: CaCO3+2HCl = CaCl2+H2O+CO2. Two grams of calcium carbonate will readily bring 100 ml of hydrochloric acid to a pH above 6. The increase in gastric pH diminishes the activity of pepsin in the gastric secretion. Up to 30% of the oral calcium load may be absorbed.
","250 mg or 500 mg tablet: Calcium Carbonate is always used orally and when used as an antacid the recommended doses for adults are equivalent to 540-2000 mg Calcium Carbonate per day, doses for children being half of those for adults. As a dietary supplement, such as for the prevention of osteoporosis, 1250-3750 mg Calcium Carbonate (500-1500 mg calcium) daily is recommended in general, but again this will need to be tailored to the individual patient depending on any specific disease such as Calcium deficiency, malabsorption or parathyroid function. In pregnancy and lactation the recommended daily dose of calcium is 1200-1500 mg. In chronic renal failure the doses used vary from 2.5-9.0 gm Calcium Carbonate per day and need to be adjusted according to the individual patient. To maximize effective phosphate binding in this context the Calcium Carbonate should be given with meals.
1000 mg tablet: 2000-3000 mg tablet when symptoms occur; may be repeated hourly if needed or as directed by the physician.
",,"Calcium Carbonate may enhance the cardiac effects of digoxin and other cardiac glycosides, if systemic hypercalcaemia occurs. Calcium Carbonate may interfere with the absorption of concomitantly administered tetracycline preparations and in chronic renal failure modification of vitamin D therapy may be required to avoid hypercalcaemia when Calcium Carbonate is used as the primary phosphate binder.
","
+- Hypercalcaemia and hyperparathyroidism
+- Hypercalciuria and nephrolithiasis
+- Zollinger-Ellison syndrome
+- Concomitant digoxin therapy (requires careful monitoring of serum calcium level)
+
+When hypercalcaemia occurs, discontinuation of the drug is usually sufficient to return serum calcium concentrations to normal. Calcium salts should be used cautiously in patients with sarcoidosis, renal or cardiac disease, and in patients receiving cardiac glycosides.
","Orally administered Calcium Carbonate may be irritating to the GI tract. It may also cause constipation. Hypercalcaemia is rarely produced by administration of calcium alone, but may occur when large doses are given to patients with chronic renal failure.
","Calcium containing drugs have been widely used in pregnancy by way of oral calcium supplementation or antacid therapy. Calcium Carbonate can be used in lactating women too.
",,"Use in children: Calcium carbonate has been extensively studied in children and infants with chronic renal failure and is both safe and effective.
Use in elderly: In case of elderly patients with renal failure when calcium carbonate is taken constipation may be troublesome one for this group. For this reason, monitoring of serum calcium and phosphate is of course indicated for elderly patients.
",,,,"Store in a cool, dry place in controlled room temperature.
",10
+171,Calcium Acetate,calcium-acetate-171,https://medex.com.bd/attachments/Zwm0fI0Obbmr5jrUSCkKRHXeJQLj7Q/calcium-acetate-prescribing-information,,,"Calcium Acetate is indicated for the control of hyperphosphatemia in end stage renal disease (ESRD) and does not promote aluminum absorption.
",,"Calcium Acetate when taken with meals, combines with dietary phosphate to form insoluble Calcium Phosphate which is excreted in the feces. Maintenance of serum phosphorus below 6.0 mg/dl is generally considered as a clinically acceptable outcome of treatment with phosphate binders. Calcium Acetate is highly soluble at neutral pH, making the Calcium readily available for binding to phosphate in the proximal small intestine. Orally administered Calcium Acetate from pharmaceutical dosage forms has been demonstrated to be systemically absorbed up to approximately 40% under fasting conditions and up to approximately 30% under non fasting conditions. This range represents data from both healthy subjects and renal dialysis patients under various conditions.
","The recommended initial dose of Calcium Acetate for the adult dialysis patient is 2 tablets with each meal. The dosage may be increased gradually to bring the serum phosphate level below 6 mg/dl, as long as hypercalcemia does not develop. Most patients require 3-4 tablets with each meal.
Pediatric Use: The safety and efficacy of Calcium Acetate have not been established.
Geriatric Use: In clinical studies, no overall differences in safety or effectiveness were observed between the geriatric and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
",,"Calcium Acetate may decrease the bioavailability of tetracycline.
","Calcium Acetate is contraindicated in patients with hypercalcemia.
","Patients may occasionally experience nausea during Calcium Acetate therapy. Hypercalcemia may occur during treatment with Calcium Acetate. Mild hypercalcemia (Ca >10.5 mg/dl) may be asymptomatic or manifest itself as constipation, anorexia, nausea and vomiting. More severe hypercalcemia (Ca >12 mg/dl) is associated with confusion, delirium, stupor and coma. Mild hypercalcemia is easily controlled by reducing the Calcium Acetate dose or temporarily discontinuing therapy. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing Calcium Acetate therapy. Decreasing dialysate calcium concentration could reduce the incidence and severity of Calcium Acetate induced hypercalcemia. The long-term effect of Calcium Acetate on the progression of vascular or soft-tissue calcification has not been determined. Isolated cases of pruritus have been reported which may represent allergic reactions.
","Teratogenic Effects: Category C. Animal reproduction studies have not been conducted with Calcium Acetate. It is also not known whether Calcium Acetate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Calcium Acetate should be given to a pregnant woman only if clearly needed.
","Excessive dosage of Calcium Acetate induces hypercalcemia; therefore, early in the treatment during dosage adjustment serum calcium should be determined twice weekly. Should hypercalcemia develop, the dosage should be reduced or the treatment discontinued immediately depending on the severity of hypercalcemia. Calcium Acetate should not be given to patients on digitalis, because hypercalcemia may precipitate cardiac arrhythmias. Calcium Acetate therapy should always be started at low dose and should not be increased without careful monitoring of serum calcium. The patient should be informed about compliance with dosage instructions, adherence to instructions about diet and avoidance of the use of nonprescription antacids. Patients should be informed about the symptoms of hypercalcemia.
",,"Administration of Calcium Acetate in excess of the appropriate daily dosage can cause severe hypercalcemia.
",,,"Store at 15o C to 30o C in a dry place protected from light. Keep out of reach of children.
",10
+167,Calcium + Vitamin D3 + Vitamin C + Vitamin E + Multimineral,calcium-vitamin-d3-vitamin-c-vitamin-e-multimineral-167,,Specific mineral & vitamin combined preparations,Vitamin deficiency,"This combination is indicated to maintain strong bones and teeth as well as the health of the muscles and nerves. It is also indicated for the prevention & treatment of osteoporosis & post-menopausal osteoporosis. It is needed for bone development and constant regeneration of bone as well.
","Specific mineral & vitamin combined preparations
","This medicine is an absolute bone health formula with more than half a dozen key nutrients. Calcium decreases the rate of bone loss from the femoral neck, the spine and the total body. Since calcium is a nutrient, not a drug, the positive effects of supplemental calcium are most pronounced among women with low to moderate calcium intake. Vitamin D3 helps the body to absorb calcium which helps to reduce age-related bone loss and bone fractures related to osteoporosis. Magnesium helps the body to absorb both calcium and vitamin D3. It also helps to synthesize proteins. Low magnesium status has been associated with postmenopausal osteoporosis. The trace minerals Zinc, Copper and Manganese all play a role in bone development. Zinc is a part of an antioxidant enzyme that helps to prevent cellular destruction, which can cause problems with bone growth and maturation. Copper keeps bones free from thinning. Fifty percent of the total copper content in the body is in the bones and muscles. Manganese, in combination with other trace minerals, helps to prevent bone loss and osteoporosis. Boron works with magnesium and vitamin D3 to enhance calcium absorption and helps to maintain calcium levels in the body. Vitamin C works as an antioxidant. It is also essential for the formation of collagen and aids in iron absorption. Vitamin E serves as an antioxidant, protects biological membranes and stabilizes cellular functions.
","2 tablets per day, preferably 1 tablet in the morning and 1 tablet in the evening or as directed by the physician.
",,"The risk of hypercalcaemia is increased if calcium salts are given with thiazide diuretics as these drugs reduce urinary calcium excretion. The effects of digitalis glycosides on the heart are enhanced by calcium. Calcium salts may reduce the absorption of fluoride, some fluoroquinolones, tetracyclines and iron.
","Hypersensitivity to any of the ingredients. Periodic checks of plasma calcium levels and urinary calcium excretion should be made in patients with mild to moderate renal failure or mild hypercalciuria.
","Calcium salts may cause mild gastrointestinal side effects such as constipation, flatulence, nausea, abdominal pain & bloating. Hypercalcaemia & in rare cases hypercalciuria have been seen with long term intake of calcium at high doses. Side effects from micronutrients are rare.
","Recommended in pregnancy and lactation.
","If there is any pre-existing heart disease or kidney disease, precautions should be taken.
","Data is insufficient regarding use in children.
","Symptoms of overdose may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metalic taste, stomach cramps, unconsciousness, diarrhoea, weakness, headache, constipation, dizziness or irritability.
",,,"Store in a dry and cool place, away from direct light.
",12
+166,Calcitriol + Calcium Citrate,calcitriol-calcium-citrate-166,,Specific mineral & vitamin combined preparations,Rickets,"Calcitriol & Calcium combination is indicated for Osteoporosis, Hypoparathyroidism, Hypocalcaemia, Osteomalacia rickets, Renal osteodystrophy.
","Specific mineral & vitamin combined preparations
","Calcium salt can be used in the prevention and treatment of calcium deficiency states or negative calcium balance. It is also used as an adjunct in the prevention and treatment of osteoporosis.
Calcitriol promotes calcium absorption in the intestines and retention at the kidneys thus increasing serum calcium levels. It also increases renal tubule phosphate resorption consequently decreasing serum phosphatase levels, PTH levels and bone resorption.
","Hyperparathyroidism in renal failure: 0.25 mcg/day or alternate day. May increase slowly.
Hypoparathyroidism or pseudohypoparathyroidism: 0.5-2 mcg once daily.
Vitamin D dependent rickets: 0.015-0.02 mcg/kg/day. Maintenance: 0.03-0.06 mcg/kg/day. Max: 2 mcg/day.
Hyperparathyroidism in dialysis patients: 0.5-4 mcg 3 times/wk. Max: 8 mcg 3 times/wk.
Hyperparathyroidism in renal failure: 0.5 mcg 3 times/wk, may increase by 0.25-0.5 mcg at 2-4 wk intervals. Maintenance: 0.5-3 mcg 3 times/wk.
",,"Calcium: Co-administration with thiazide diuretics or vit D may lead to milk-alkali syndrome and hypercalcaemia. Decreased absorption with corticosteroids. Decreases absorption of tetracyclines, atenolol, iron, quinolones, alendronate, Na fluoride, Zn and calcium-channel blockers. Enhances cardiac effects of digitalis glycosides and may precipitate digitalis intoxication.
Calcitriol: Hypermagnesaemia may develop in patients on chronic renal dialysis. Hypercalcaemia in patients on digitalis may precipitate cardiac arrhythmias. Intestinal absorption of calcitriol may be reduced by cholestyramine and colestipol. Phenytoin, barbiturates may decrease the T1/2 of calcitriol. May develop hypercalcaemia with thiazide diuretics.
","Hypercalcaemia; evidence of vitamin D toxicity, pregnancy & lactation.
","Weakness; headache; somnolence; nausea; vomiting; dry mouth; constipation; muscle pain; bone pain; metallic taste; polyuria; polydipsia; anorexia; irritability; weight loss; nocturia; mild acidosis; reversible azotemia; generalized vascular calcification; nephrocalcinosis; conjunctivitis (calcific); pancreatitis; photophobia; rhinorrhoea; pruritus; hyperthermia; decreased libido; elevated BUN; albuminuria; hypercholesterolaemia; elevated AST and ALT; ectopic calcification; hypertension; cardiac arrhythmias.
","Pregnancy Category-C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","Idiopathic hypercalcaemia. Pediatric doses must be individualised and monitored under close medical supervision. Coronary disease, renal function impairment and arteriosclerosis, especially in the elderly. Hypoparathyroidism.
",,,,,,9
+165,Calcitriol,calcitriol-165,https://medex.com.bd/attachments/POQbTDhhRj8HFCA7ORB4RBdW3X31P9/calcitriol-capsule-and-oral-solution-prescribing-information,Vitamin in bone formation,Secondary hyperparathyroidism,"Calcitriol is indicated in-
+
+- Post-menopausal osteoporosis
+- Renal osteodystrophy
+- Postsurgical hypoparathyroidism
+- Idiopathic hypoparathyroidism
+- Pseudohypoparathyroidism
+- Secondary hyperparathyroidism in patients with moderate to severe chronic renal failure (pre-dialysis)
+- Vitamin D dependent rickets
+
","Vitamin in bone formation, Vitamin-D preparations
","Calcitriol is one of the most important active metabolites of vitamin D3. It is normally formed in the kidneys from its precursor, 25-hydroxycholecalciferol. Calcitriol promotes intestinal absorption of calcium and regulates bone mineralization. The key role of Calcitriol is the regulation of calcium homeostasis, which includes stimulation effects on osteoblastic activity in the skeleton.
","The optimal daily dose of Calcitriol capsule must be carefully determined for each patient on the basis of serum calcium level.
In Post-menopausal Osteoporosis: The recommended dose of Calcitriol capsule is 0.25 mcg twice daily.
In Renal Osteodystrophy (dialysis patients): The initial daily dose is 0.25 mcg of Calcitriol capsule. In patients with normal or only slightly reduced calcium levels, doses of 0.25 mcg every other day are sufficient.
In Hypoparathyroidism and Rickets: The recommended initial dosage of Calcitriol capsule is 0.25 mcg/day which given in the morning. If within 2-4 weeks satisfactory response is not observed by usual dose then dose may be increased at 2-4 weeks intervals.
The recommended intravenous initial dose of Calcitriol injection, depending on the severity of the hypocalcemia and/or secondary hyperparathyroidism, is 1 mcg (0.02 mcg/kg) to 2 mcg administered three times weekly, approximately every other day. Doses as small as 0.5 mcg and as large as 4 mcg three times weekly have been used as an initial dose. If a satisfactory response is not observed, the dose may be increased by 0.5 to 1 mcg at two to four week intervals.
",,"Concomitant treatment with a thiazide diuretics increases the risk of hypercalcemia. Calcitriol dosage must be determined with care in patients undergoing treatment with digitalis as hypercalcemia in such patients may precipitate cardiac arrhythmias. Magnesium containing drugs (e.g.,antacids) may cause hypermagnesemia.
","Calcitriol is contraindicated in patients with known hypersensitivity to any of its ingredients. Calcitriol is also contraindicated in all diseases associated with hypercalcemia.
","Occasional symptoms include anorexia, headache, vomiting and constipation. Chronic effects may include dystrophy, fever, polyuria, dehydration, apathy and urinary tract infection.
","There is no evidence that vitamin D is teratogenic in humans. Calcitriol may be used during pregnancy only if the benefits outweigh the potential risk to the fetus. Mothers may breast feed while taking Calcitriol but serum calcium levels of the mother and infant should be monitored.
","During Calcitriol therapy if the serum calcium levels rise to 1 mg/100 ml above normal or serum creatinine rises to >120 µmol/l, the dosage of Calcitriol should be substantially reduced or treatment stopped.
","Secondary hyperparathyroidism in patients with moderate to severe chronic renal failure (pre-dialysis)-
+
+- The recommended initial dosage of Calcitriol is 0.25 mcg/day in adults and pediatric patients 3 years of age or older. This dosage may be increased if necessary to 0.5 mcg/day.
+- For pediatric patients less than 3 years of age, the recommended initial dosage of Calcitriol is 10 to 15 ng/kg/day.
+- In Elderly: No dosage adjustment are required.
+
",,,,"keep in a dry place away from light and heat. Keep out of the reach of children.
",11
+69,Amoxicillin Trihydrate,amoxicillin-trihydrate-69,https://medex.com.bd/attachments/VPa5Cdp47AxpVmdom2ovtPDnt1ZCS7/amoxicillin-trihydrate-prescribing-information,Broad spectrum penicillins,Skin and skin sructure infections,"Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
+
+- Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
+- Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
... Read more
Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
+
+- Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
+- Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
+- Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
+- Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
+- Venereal disease (i.e. acute uncomplicated gonorrhoea)
+- In dental abscess, it is used as short-term therapy.
+- It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
+
","Broad spectrum penicillins
","Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
","Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
+
+- Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
+- Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
+- Pneumonia: Recommended dose is 500-1000 mg three times daily.
+- Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
+- Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
+- Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
+- In renal impairment: it may be necessary to reduce the total daily dosage.
+
","Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
","Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
","Amoxicillin is contraindicated in penicillin hypersensitive patients.
","Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
","US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
","The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
",,,,"Amoxycillin 500 mg Injection:
+
+- Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
+- Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
+
","Keep in a dry place away from light and heat. Keep out of the reach of children.
",12
+70,Amoxicillin + Clavulanic Acid,amoxicillin-clavulanic-acid-70,https://medex.com.bd/attachments/gPyL7xZuvzMdijW9H0yJME2ssAUBeR/amoxicillin-clavulanic-acid-prescribing-information,Broad spectrum penicillins,Severe or recurrent respiratory tract infections,"Co-amoxiclav is indicated for short-term treatment of bacterial infections at the following sites:
+
+- Upper respiratory tract infections (including ENT) e.g.tonsillitis,sinusitis,otitis media.
+- Lower respiratory tract infections e.g.acute and chronic bronchitis, lobar and bronchopneumonia.
... Read more
Co-amoxiclav is indicated for short-term treatment of bacterial infections at the following sites:
+
+- Upper respiratory tract infections (including ENT) e.g.tonsillitis,sinusitis,otitis media.
+- Lower respiratory tract infections e.g.acute and chronic bronchitis, lobar and bronchopneumonia.
+- Genito-urinary tract infections e.g.cystitis,urethritis,pyelonephritis.
+- Skin and soft tissue infections.
+- Bone and joint infections e.g.osteomyelitis.
+- Other infections e.g.septic abortion,puerperal sepsis,intra-abdominal sepsis etc.
+
","Broad spectrum penicillins
","Pharmacodynamic properties: Co-amoxiclav is an antibacterial combination consisting of the antibiotic Amoxicillin and the (3-lactamase inhibitor Clavulanic Acid. Amoxicillin has a broad spectrum of bactericidal activity against many Gram-positive & Gram-negative microorganisms but it is susceptible to degradation by (3-lactamases and therefore the spectrum of activity does not include microorganisms, which produce these enzymes. Clavulanic acid possesses the ability to inactivate a wide range of beta-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins. Thus Clavulanic acid in this preparation protects Amoxicillin from degradation by (3-lactamase enzymes and effectively extends the antibiotic spectrum to embrace a wide range of microorganisms.
Pharmacokinetic properties: The pharmacokinetics of the two components of Co-amoxiclav is closely matched. Peak serum levels of both occur about one hour after oral administration. Absorption of Co-amoxiclav is optimized at the start of a meal. Both clavulanate and Amoxicillin have low levels of serum binding; about 70% remains free in the serum. Doubling the dosage of Co-amoxiclav approximately doubles the serum levels achieved.
","Adults and children over 12 years:
Tablet:
+
+- The usual adult dose is one 625 mg Tablet every 12 hours or one 375 mg Tablet every 8 hours.
+- For more severe infections and infections of the respiratory tract, the dose should be one 1 gm Tablet every 12 hours or one 625 mg Tablet every 8 hours.
+
+
Suspension:
+
+- Children 6-12 years: 2 teaspoonful every 8 hours.
+- Children 1-6years: 1 teaspoonful every 8 hours.
+- Children below 1 year: 25 mg/kg/day in divided doses every 8 hours, for example a 7.5 kg child would require 2 ml suspension t.i.d, Treatment should not be extended beyond 14 days without review.
+
+
Forte suspension:
+
+- The usual recommended daily dosage: 25/3.6 mg/kg/day in mild to moderate infections (upper respiratory tract infections e.g. recurrent tonsilitis, lower respiratory infections, and skin and soft tissue infections)।
+- For serious infections: 45/6.4 mg/kg/day for the treatment of more serious infections (upper respiratory tract infections, e.g. otitis media and sinusitis, lower respiratory infections e.g. bronchopneumonia, and urinary tract infections).
+
+Children of 2 to 12 years:
Mild to moderate infections:
+
+- 25/3.6 mg/kg/day (Suspension)
+- 2-6 years (13-21 kg) 2.5 ml suspension b.i.d
+- 7-12years (22-40kg) 5 ml suspension b.i.d
+
+Serious infections:
+
+- 45/6.4 mg/kg/day (Forte Suspension)
+- 2-6 years (13-21 kg) 5 ml suspension b.i.d
+- 7-12 years (22-40 kg) 10 ml suspension b.i.d
+
+
IV InjectionAdults-
+
+- Usually, 1.2 gm every 8 hours
+- Increased in more serious infections to 1.2 gm every 6 hours
+- For surgical prophylaxis: The usual dose is 1.2 gm at induction, for high risk procedures (eg. colorectal surgery) up to 2-3 gm may be given every 8 hours.
+
+Children-
+
+- 0 to 3 months: 30 mg/kg every 8 hours. (every 12 hours in the perinatal period and in premature infants.
+- 3 months to 12 years: Usually 30 mg/kg every 8 hours increased in more serious infection to 30 mg/kg every 6 hours.
+
","Oral dosage form: This may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanic acid are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanic acid should be taken at the start of the meal.
IV injection is not suitable for intramuscular or subcutaneous administration. The reconstituted vial can be administered intravenously by injection (over 2 minutes) or slow intravenous infusion (30 minutes). The contents of the content of the vial must be used within 20 minutes and thereafter any unused material should be discarded.
","Prolongation of bleeding time and prothrombin time have been reported in some patients receiving Co-amoxiclav. In common with other broad-spectrum antibiotics, Co-amoxiclav may reduce the efficacy of oral contraceptives and patients should be warned accordingly. Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. There are no data on the concomitant use of Co-amoxiclav and allopurinol.
","History of Penicillin hypersensitivity. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics e.g. cephalosporins. Also contraindicated for patients with a previous history of Co-amoxiclav or Penicillin-associated cholestatic jaundice.
","Side effects, as with Amoxicillin, are uncommon and mainly of a mild and transitory nature. Diarrhoea, pseudomembranous colitis, indigestion, nausea, vomiting and candidiasis have been reported, if gastrointestinal side effects occur with oral therapy, that may be reduced by taking Co-amoxiclav at the start of meals. Hepatitis and cholestatic jaundice have been reported rarely but are usually reversible. Urticarial and erythematous rashes sometimes occur. Rarely erythema multiforme, Stevens-Johnson Syndrome and exfoliative dermatitis have been reported. In common with other beta-lactam antibiotics, angioedema and anaphylaxis have been reported.
","Animal studies with orally and parenterally administered Co-amoxiclav have shown no teratogenic effect. The drug has been used orally in human pregnancy in a limited number of cases with no untoward effect; however, the use of Co-amoxiclav in pregnancy is not recommended unless considered essential by the physician. During lactation, trace quantities of Amoxicillin can be detected in breast milk.
","Co-amoxiclav should be used with care in patients on anticoagulation therapy or with severe hepatic dysfunction. In patients with moderate or severe renal impairment, dosage should be adjusted. During the administration of a high dose of Co-amoxiclav adequate fluid intake and urinary output should be maintained to minimize the possibility of crystalluria.
","The dose should be adjusted in case of patients with renal impairment
Adult:
+
+- Mild impairment (Creatinine clearance> 30ml/minute): No changein dosage.
+- Moderate impairment (Creatinine clearance 10-30 ml/minute): One 375 Tablet or one 625 Tablet 12 hourly or 1.2 gm IV followed by 0.6 gm IV 12 hourly.
+- Severe impairment (Creatinine clearance <10 ml/minute): Not more than one 375 mg tablet 12 hourly or 1.2 gm IV followed by 0.6 gm IV 24 hourly. Dialysis decreases serum concentrations of this preparation and an additional 0.6 gm IV dose may need to be given during dialysis and at the end of dialysis.
+
+
Children:
+
+- A similar reduction in dosage should be made for children.
+- Administration hepatic impairment: Dose with caution; monitor hepatic function at regular intervals.
+
","Problems of overdose with Co-amoxiclav are unlikely to occur, if encountered gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Co-amoxiclav may be removed from the circulation by haemodialysis.
",,"IV injection: 1.2 gm IV injection can be reconstituted by dissolving the powder in 20 ml Water for Injection BP. This IV injection should not be reconstituted or mixed with: Dextrose solution, Sodium Bicarbonate solution for injection, Protein Hydrolysates or other Proteinaceous fluids, blood or plasma, Intravenous lipids. However, the reconstituted solution may be injected into the drip tubing of infusion fluids containing glucose, bicarbonate and dextran over a period of 3-4 minutes.
","This should be stored below 25°C, protected from light and moisture. Once reconstituted suspension should be kept in the refrigerator (but not frozen) and should be usedby 7 days. Once reconstituted vial must be used within 20 minutes.
",14
+1712,Herbal cough syrup [Glycyrrhiza Glabra],herbal-cough-syrup-glycyrrhiza-glabra-1712,,Herbal and Nutraceuticals,Tonsillitis,"This syrup is indicated in-
+
+- Cough
+- Catarrh
+- Catarrhal fever & Catarrhal pain
+- Headache & Sore throat
+- Bronchitis
+- Tonsillitis
+- Hoarseness of voice
+
","Herbal and Nutraceuticals
","It contains Licorice (Glycyrrhiza glabra), Sebesten Plum (Cordia dichotoma), Common Mallow (Malva sylvestris), Marsh Mallow (Althaea officinalis) and other valuable natural ingredients, which have been recognized as the most efficacious herbal cure for cough cold, bronchitis and inflammatory diseases of the respiratory tract.
","1 sachet of Joshina be dissolved in a cup of hot water to be taken 2-3 times daily or as directed by the physician. If sweetened with 2 or 3 crushed Sualin tablets, it enhances its effects.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1515,Herbal cough syrup [Adhatoda Vasica],herbal-cough-syrup-adhatoda-vasica-1515,,Herbal and Nutraceuticals,Whooping cough,"This herbal cough syrup liquefies phlegm. It soothes irritation of the throat. Helps to relieve hoarseness. It is a remedy for all types of cough such as dry irritable cough, allergic & smokers cough.
","Herbal and Nutraceuticals
","
+- Adhatoda vasica (Basok): Relieves cough & bronchial spasm. It liquefies mucous.
+- Piper longum (Pipul): Relieves cold allergy & asthma.
+- Glycyrrhiza glabra (Jashthi Modhu) : Relieves irritation of throat. Enhances the immune system. It is anti-inflammatory, demulcent & expectorant.
+- Piper nigrum (Marich): It is fungistatic, bacteriostatic & anti-inflammatory.
+- Zingiber officinale (Shunthi): It is antihistaminic. Very much effective in common cold.
+- Terminalia chebula (Haritaki): It removes toxin from the body. It has beneficial effect on all tissues.
+- Vitis venifera (Kismiss): Relieves cough and general tonic.
+- Acorus calamus (Bacha): Helps in bronchial catarrh & intermittent fever.
+- Saussurea lappa (Kur): It is antiseptic & disinfectant. It is very useful in bronchial asthma.
+- Syzygium aromaticum (Labango): Useful in cough & other respiratory diseases. It prevents bad breath.
+- Cinnamomum zeylanicum (Darchini): It is antibacterial & antifungal and relieves cough due to its soothing action.
+- Elettaria cardamomum (Elachi): It is aromatic in nature and shows antimicrobial activity.
+- Cinnamomum tamala (Tejpata): It is a tonic & appetizer agent.
+- Pistacia integerrima (Kakra sringi): It helps in asthma.
+- Myrica nagi ( Kotfal): It is a remedy for sore throat.
+- Woodfordia fruticosa (Daiful): It is good anti-infective agent and is useful in relieving cough due to its soothing action.
+- Tulsi extract & other ingredients: Tulsi extract & some other ingredients are added to DEVAS syrup for relieving acute cough.
+
","Children under 12 years: 1-2 teaspoonful (5-10 ml) 2-3 times a day. '
Adult: 3 teaspoonful (15 ml) 2-3 times a day.
Some warm water may be added for better results.
",,"No report is available.
","No report is available on contraindication. It may be happen in patients who are hypersensitive to any of its ingredients.
","This syrup is proven as safe. It is well tolerated. In high dose diarrhea, vomiting may occur.
","The safety of this syrup in pregnancy has not been studied. Therefore, it should be used with caution during pregnancy.
",,,,,,"Keep out of reach of children. Keep away from direct sunlight. Store in a cool and dry place.
",9
+2065,Hazmina,hazmina-2065,https://medex.com.bd/attachments/P1E5qLXUXHhLMo7euaEACtDYQqKhuj/hazmina-prescribing-information,Herbal and Nutraceuticals,Indigestion,"Digestive and carminative to correct indigestion, dyspepsia, flatulence, constipation, abdominal pain due to gases, stomach and liver disorders.
","Herbal and Nutraceuticals
","Hazmina is a specialized formulation of several herbs and natural ingredients that helps to control acidity, flatulence, and indigestion. It even tones up the digestive system as a whole. It also makes a fine balance between liver function and gastric activities.
","Adults: 2 teaspoonfuls 2-3 times daily.
Children: 1⁄2-1 teaspoonful 2-3 times daily or as directed by the registered physician.
",,"No report is available.
","No report is available on contraindication.
","No significant side effect has been observed in proper dosages.
","The safety of Hazmina in pregnancy has not been established. Therefore, it should be used with caution during pregnancy.
",,,,,,"Store in a cool & dry place away from direct sunlight. Keep it out of reach of children.
",9
+1771,Habb-e-Nishat,habb-e-nishat-1771,,Herbal and Nutraceuticals,Erectile dysfunction,"This is indicated in Erectile dysfunction, low virility, fluidity of semen and spermatorrhoaea.
","Herbal and Nutraceuticals
","Myristica fragrans (Mace): It is especially effective in helping with male sexual disorders. It increases sexual activity, libido and potency without any conspicuous adverse effects. It also helps to improve circulation of blood in the body and stimulate the brain.
Penaeus spp: It acts as an aphrodisiac and exhilarant. Improves quality blood production.
Argyeria speciosa: This herb is commonly used as an aphrodisiac and is useful in male sex disorders like early ejaculations. It stimulates nervous system.
Myristica fragrans (Nut Meg): It contains volatile oil, proteins, fats, starch and mucilage, acts as aphrodisiac, nervous stimulant and increases blood circulation.
Calx of Tin: It is useful in spermatorrhea, nocturnal emission and premature ejaculation.
Natural Silicate of magnesia & iron: It acts as antidote and exhilarant.
Crocus sativus: It has stimulating action on the nervous system and also has aphrodisiac action.
","2 tablets with milk one hour before coitus.
",,,,,,,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",5
+1703,Guggul + Barberry + Chebulic Myrobalan,guggul-barberry-chebulic-myrobalan-1703,,Herbal and Nutraceuticals,Haemorrhoids (Piles),"This is indicated in Haemorrhoid (bleeding piles), Constipation.
","Herbal and Nutraceuticals
","This is a special preparation of synergistically acting natural active ingredients such as Guggul (Commiphora mukul), Berberry (Berberis aristata), Chebulic Myrobalan (Terminalia chebula), Emblic Myrobalan (Phyllanthus emblica) etc. Hanrhoid-B acts as powerful astringent, anti-hemorrhagic, which is very effective in the treatment of Bleeding Haemorrhoids. It helps to relive swelling and inflammation of rectal mucosa. It also acts as laxative, analgesic and antiseptic.
","2 tablets twice daily or as prescribed by the physician.
",,,"There is no known contra-indication.
","No significant side effect has been observed in therapeutic dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+56,Aminocaproic acid,aminocaproic-acid-56,https://medex.com.bd/attachments/Rga7Twzq9YIiSwwmRYMSoU8ITnHAnb/aminocaproic-acid-prescribing-information,Anti-fibrinolytic drugs,Traumatic hyphema,"Aminocaproic acid used to treat excessive postoperative bleeding, especially after procedures in which a great amount of bleeding is expected, such as cardiac surgery. It can be given orally or intravenously. A meta-analysis found that lysine analogs like Aminocaproic acid significantly reduced blood ... Read more
Aminocaproic acid used to treat excessive postoperative bleeding, especially after procedures in which a great amount of bleeding is expected, such as cardiac surgery. It can be given orally or intravenously. A meta-analysis found that lysine analogs like Aminocaproic acid significantly reduced blood loss in patients undergoing coronary artery bypass grafting. Aminocaproic acid can also be used to treat the overdose and/or toxic effects of the thrombolytic pharmacologic agents tissue plasminogen activator and streptokinase.
","Anti-fibrinolytic drugs, Haemostatic drugs
","The fibrinolysis-inhibitory effects of Aminocaproic acid appear to be exerted principally via inhibition of plasminogen activators and to a lesser degree through antiplasmin activity.
","Dosage of Aminocaproic acid must be adjusted to individual cases according to the severity of the hemmohagic event. It must however born in mind that Aminocaproic acid cleared rapidly by renal rough, so that administration must be repeated every 4-6 hours. The average dose is 8-16 gm a day.i.e. 1 ampule of Aminocaproic acid according to the case, every 6 hours.
Aminocaproic acid is equally effective by mouth and intarvenous injection. In cases of particular severity, or when it is sought to obtain a high blood concentration quickly it is advisable to start treatment by intravenous rough, with slow injection of two Aminocaproic acid ampules with an interval of 30-60 minutes between them, continuing with divided doses until a dosage of 20-25 grams in the 24 hour is reached.
In any case, administration of the drug must be continued until complete cessation of all symptoms. Aminocaproic acid could be intravenously administered, following suitable dilution in Physiological solution.
",,,"
+- Aminocaproic acid should not be used when there is evidence of an active intravascular clotting process.
+- When there is uncertainty as to whether the cause of bleeding is primary fibrinolysis or disseminated intravascular coagulation (DIC), this distinction must be made before administering Aminocaproic acid Injection.
+- The following tests can be applied to differentiate the two conditions:
+- Platelet count is usually decreased in DIC but normal in primary fibrinolysis.
+- Protamine paracoagulation test is positive in DIC; a precipitate forms when protamine sulfate is dropped into citrated plasma. The test is negative in the presence of primary fibrinolysis.
+- The euglobulin clot lyses test is abnormal in primary fibrinolysis but normal in DIC.
+- Aminocaproic acid Injection must not be used in the presence of DIC without concomitant heparin.
+
","Mild muscle pain or weakness; headache, tired feeling; nausea, vomiting, stomach pain, diarrhea; (in men) decreased amount of semen when having an orgasm; stuffy nose, watery eyes; vision problems, ringing in your ears; or Mild skin rash.
","Pregnancy Category C. Animal reproduction studies have not been conducted with aminocaproic acid. It is also not known whether aminocaproic acid can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Aminocaproic Acid Injection should be given to a pregnant woman only if clearly needed.
","Safety and efficacy have not been established in patients younger than 18 years.
",,,,,"Store in a cool, dry place, protected from light. Store the suspension below 30° C. Keep out of reach of children.
",9
+1662,Amino Acid Keto Analogues,amino-acid-keto-analogues-1662,,Other genito-urinary preparations,Chronic renal failure,"Prevention and treatment of damages due to faulty or deficient protein metabolism in chronic kidney disease in connection with a limited dietary protein intake of 40 g/day or less (adult). Usually, this applies to patients whose glomerular filtration rate (GFR) is less than 25 mL/min.
","Other genito-urinary preparations
","Amino Acid Keto Analogues tablets are administered for nutrition therapy in chronic kidney disease. Amino Acid Keto Analogues allow the intake of essential amino acids while minimizing the amino-nitrogen intake. The use of Amino Acid Keto Analogues in combination with a very low protein diet allows reducing nitrogen intake while preventing the deleterious consequences of inadequate dietary protein intake and malnutrition.
","Adult dose (70 kg body weight): 4 to 8 tablets three times daily during meals. The tablets must not be chewed. Ingestion during meals facilitates proper absorption and the metabolization into the corresponding amino acids.
Pediatric population: No experience has been gained so far with the administration in pediatric patients.
",,"Concomitant administration of calcium-containing drugs may cause or aggravate elevated serum calcium levels. Drugs that form hardly soluble compounds with calcium (e.g. tetracyclines, quinolines such as ciprofloxacin and norfloxacin as well as drugs containing iron, fluoride or estramustine) should not be taken at the same time with Amino Acid Keto Analogues to avoid disturbed absorption of the active substances. An interval of at least two hours should elapse between the ingestion of Amino Acid Keto Analogues and these drugs.
","Hypersensitivity to the active substances or to any of the excipients, Hypercalcaemia, Disturbed amino acid metabolism.
","Hypercalcaemia (Very Rare), If hypercalcaemia occurs, the intake of vitamin D should be reduced. In case of persisting hypercalcaemia, the dose of Amino Acid Keto Analogues as well as the intake of any other calcium sources has to be reduced.
","There are no adequate data from the use of Amino Acid Keto Analogues in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women. No experience has been made so far with the use during lactation.
","
+- The serum calcium level should be monitored regularly
+- Ensure sufficient calorie intake
+- In the presence of hereditary phenylketonuria, attention should be given to the fact that Amino Acid Keto Analogues contains phenylalanine
+- Monitoring of the serum phosphate levels is needed in case of concomitant administration of aluminium hydroxide
+
",,,,,"Store at a temperature not exceeding 30°C in a dry place. Protect from light & moisture.
",10
+57,Amino Acid + Glucose + Electrolytes,amino-acid-glucose-electrolytes-57,https://medex.com.bd/attachments/K6Ve0KzuEY7qHAP3KTCuRh4spP4y0E/amino-acid-glucose-electrolytes-prescribing-information,Parenteral nutritional preparations,Prevent nitrogen loss,"This is indicated as a source of amino acids, glucose and electrolytes in adult and pediatric patients needing IV nutrition. This is particularly suitable for patients with basal amino acid requirements.
","Parenteral nutritional preparations
","A crystalline amino acid solution provides crystalline amino acids to promote protein synthesis and wound healing, and to reduce the rate of endogenous protein catabolism. Amino Acids given by central venous infusion in combination with concentrated dextrose, electrolytes, vitamins, trace metals, and ancillary fat supplements, constitutes total parenteral nutrition (TPN). Amino Acids can also be administered by peripheral vein with dextrose and maintenance electrolytes.
","Adults: The nitrogen requirement for maintenance of body protein mass depends on the patient's condition (nutritional state and degree of metabolic stress). The requirements are 0.10-0.15g nitrogen/kg/day (no or minor metabolic stress and normal nutritional state), 0.15-0.20g nitrogen/kg/day (moderate metabolic stress with or without malnutrition) and up to 0.20-0.25g nitrogen/kg/day (severe catabolism as in burns, sepsis and trauma). The dosage range is 0.10-0.25 g nitrogen/kg/day corresponds to 11-27 ml/kg/day. In obese patients, the dose should be based on the estimated ideal weight. Depending upon the patient’s requirements, 1000-2000 ml may be infused intravenously per 24 hours. This should be infused slowly; at a rate not exceeding 500 ml in 3 hours corresponding to approximately at rates 1.4-2.8 ml (30-60 drops) per minute.
Infants and children: In infants & children, a maximal rate of infusion of 30 ml/kg body weight/day is recommended, with a step-wise increase in the rate of administration during the first week of treatment.
",,"At the recommended dosage this solution has no pharmacological effect and is expected not to interact with other medicaments.
","This preparation is contraindicated in patients with inborn errors of amino acids metabolism, severe liver damage & severe uremia when dialysis facilities are not available. Due to the content of the glucose, this preparation is contraindicated in patients with hyperosmolar nonketotic diabetic coma. This preparation is also contraindicated in patients with known hypersensitivity to any of its ingredients.
","This preparation is usually well tolerated. Nausea occurs rarely. Vomiting, flushing and sweating have been observed during infusion of the solution at rates exceeding the recommended maximal rate. Transient increases in liver test during intravenous nutrition have been reported. The reasons are at present unclear. The underlying disease and the components and their amount in the intravenous feeding regimens have been suggested. Hypersensitivity reactions have been reported. As with all hypertonic infusion solution, thrombophlebitis may occur when peripheral veins are used. The incidence may be reduced by the simultaneous infusion of 10% fat emulsion.
","Successful and safe administration of amino acid solution during pregnancy in human has been reported. Animal reproduction studies have not been carried out with 7% amino acid IV infusion with 10% glucose & electrolytes.
","Hyperphenylalaninemia has been noted in severely ill, premature infants. In these patients, monitoring of the phenylalanine level is recommended and the infusion rate to be adjusted as needed. This preparation should be used with caution in patients with diabetes mellitus, severe heart failure or with renal function in combination with fluid restriction or oliguria/anuria of other origin. In patient with hyperglycemia, administration of exogenous insulin might be necessary. Do not use if the solution is turbid or contains particles. Discard any unused portion.
",,,,,"Protect from light and store between 15°C to 25°C temperature. Avoid freezing. Keep away from the reach of children.
",10
+1788,Amino Acid + Dextrose + Eloctrolytes,amino-acid-dextrose-eloctrolytes-1788,,Parenteral nutritional preparations,Supplement for intravenous nutrition,"This is used for a source of amino acids, glucose and electrolytes in adult and pediatric patients needing IV nutrition. This is particularly suitable for patients with basal amino acid requirements.
","Parenteral nutritional preparations
",,"Adults: The nitrogen requirement for maintenance of body protein mass depends on the condition of the patient (nutritional state and degree of metabolic stress). The requirements are 0.1-0.15 g nitrogen/kg body weight/day (no or minor metabolic stress and normal nutritional state), 0.15-0.2 g nitrogen/kg body weight/day (moderate metabolic stress with or without malnutrition) and up to 0.2-0.25 g nitrogen/kg body weight/day (severe catabolism as in burns, sepsis and trauma). The dosage range 0.1-0.25 g nitrogen/kg body weight/day corresponds to 11-27 mL Amino Acid IV Infusion with 10% Glucose and Electrolytes /kg body weight/day, respectively.
Obese patient: In obese patients, the dose should be based on the estimated ideal weight. Depending upon patient requirements, up to 1000-2000 mL of Amino Acid IV Infusion with 10% Glucose and Electrolytes may be infused IV per 24 hrs. Amino Acid IV Infusion with 10% Glucose and Electrolytes should be infused slowly, at a rate not exceeding 1000 mL in 6 hrs corresponding to approximately 2.8 mL/min. In patients with basal amino acids requirements, the less concentrated Amino Acid IV Infusion with 10% Glucose and Electrolytes may be used.
Infants and Children: In children and infants, a maximal rate of infusion of 30 mL Amino Acid IV Infusion with 10% Glucose and Electrolytes/kg body weight/day is recommended, with a stepwise increase in the rate of administration during the 1st week of treatment.
",,"At the recommended dosage the amino acid have no pharmacological effects and is not expected to interact with other medicaments.
","Patients with inborn errors of amino acid metabolism, severe liverdysfunction and in severe uremia when dialysis facilities are not available. Due to the content of glucose,this drug is contraindicated in patients with hyperosmolar nonketotic diabetic coma.
","Nausea occurs rarely. Transient increases in liver tests during IV nutrition have been reported. Hypersensitivity reactions have been reported with amino acid solutions. As with all hypertonic infusion solutions, thrombophlebitis may occur when peripheral veins are used. Hyperphenylalaninemia may occur in severely ill, premature infants.
","No specific studies have been performed to assess the safety of Amino Acids+Electrolytes+Glucose in pregnancy and lactation. The prescriber should consider the benefit/risk relationship before administering this combination to pregnant or breastfeeding women.
","This IV infusion is accompanied by increased urinary excretion of the trace elements copper and, in particular zinc, which should be taken into account in the dosing of trace elements, particularly during long-term IV nutrition. Hyperphenylalaninemia has been noted in severely ill premature infants. In these patients, monitoring of the phenylalanine level is recommended and the infusion rate adjusted as needed. This should be used with caution in patients with diabetes mellitus, severe heart failure or with renal function in combination with fluid restrictions or oliguria/anuria of other origin. In patients with hyperglycemia, administration of exogenous insulin might be necessary.
",,"If Amino Acid, Glucose & Electrolytes combination is administered at a higher rate than recommended, there is an augmented risk for nausea, vomiting and sweating. When peripheral veins are used thrombophlebitis may occur. Osmotic diuresis with dehydration may occur if the dosage recommendations are exceeded. There is also a risk of symptoms related to hyperglycemia. In case of symptoms due to overdose, the infusion should be slowed down or discontinued.
",,,"Protect from light and store between 15°C to 25°C temperature. Avoid freezing.
",10
+205,Carboxymethylcellulose Sodium,carboxymethylcellulose-sodium-205,https://medex.com.bd/attachments/M2B94yFKVM6fhIaddEyTu0DrxX78fC/carboxymethylcellulose-sodium-prescribing-information,,,"It is used as a lubricant to relieve irritation and discomfort due to dryness of the eye or due to exposure to wind or sun.
",,"Carboxymethylcellulose binds to the surface of corneal epithelial cells via its glucopyranose subunits binding to glucose receptors GLUT-1. The residence time of carboxymethylcellulose bound to corneal cells is approximately 2 hours as indicated by a short-term binding assay. Binding of carboxymethylcellulose to the matrix proteins stimulated corneal epithelial cell attachment, migration, and re-epithelialization of corneal wounds.
This eye drop contains Carboxymethylcellulose Sodium similar to normal tears which acts as an ocular lubricant. It provides a lubricating and hydrating protective shield on the ocular surface.
","Instill 1 drop in the affected eye(s) 4 times a day or as needed.
",,"Not known.
","This eye drop is contraindicated in patients with known hypersensitivity to any ingredient of the product.
","Burning, Eye Irritation or Pruritus, Visual disturbance, Ocular discharge were reported with this eye drop.
","Safe use during pregnancy and lactation has not been established.
","Concomitant ocular medication should be administered 15 minutes prior to the instillation of this eye drop.
","Pediatric use: This eye drop should not be used in infants and small children under 3 years.
Geriatric use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
",,,,"The drug is to be used within 30 days after the first opening. Store at temperature not exceeding 30°C in a dry place. Protect from light. The bottle is to be closed strongly immediately after use. Keep away from the reach of children.
",10
+1401,Carboprost Tromethamine,carboprost-tromethamine-1401,https://medex.com.bd/attachments/q3Fy9Nz5kNQ1yR8rlsUTNKgm2oVLSp/carboprost-tromethamine-prescribing-information,Drugs acting on the Uterus,Postpartum haemorrhage,"Carboprost Sterile Solution is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion:
+
+- Failure of expulsion of the fetus during the course of treatment by another method;
... Read more
Carboprost Sterile Solution is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion:
+
+- Failure of expulsion of the fetus during the course of treatment by another method;
+- Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity;
+- Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus;
+- Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion.
+
+Carboprost is indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. Prior treatment should include the use of intravenously administered oxytocin, manipulative techniques such as uterine massage and, unless contraindicated, intramuscular ergot preparations. Studies have shown that in such cases, the use of Carboprost has resulted in satisfactory control of hemorrhage, although it is unclear whether or not ongoing or delayed effects of previously administered ecbolic agents have contributed to the outcome. In a high proportion of cases, Carboprost used in this manner has resulted in the cessation of life threatening bleeding and the avoidance of emergency surgical intervention.
","Drugs acting on the Uterus
","Carboprost tromethamine administered intramuscularly stimulates in the gravid uterus myometrial contractions similar to labor contractions at the end of a full term pregnancy. Whether or not these contractions result from a direct effect of carboprost on the myometrium has not been determined. Nonetheless, they evacuate the products of conception from the uterus in most cases.
Postpartum, the resultant myometrial contractions provide hemostasis at the site of placentation.
Carboprost tromethamine also stimulates the smooth muscle of the human gastrointestinal tract. This activity may produce the vomiting or diarrhea or both that is common when carboprost tromethamine is used to terminate pregnancy and for use postpartum. In laboratory animals and also in humans carboprost tromethamine can elevate body temperature. With the clinical doses of carboprost tromethamine used for the termination of pregnancy, and for use postpartum, some patients do experience transient temperature increases.
In laboratory animals and in humans large doses of carboprost tromethamine can raise blood pressure, probably by contracting the vascular smooth muscle. With the doses of carboprost tromethamine used for terminating pregnancy, this effect has not been clinically significant. In laboratory animals and also in humans carboprost tromethamine can elevate body temperature. With the clinical doses of carboprost tromethamine used for the termination of pregnancy, some patients do experience temperature increases. In some patients, carboprost tromethamine may cause transient bronchoconstriction.
","Abortion and Indications 1-4: An initial dose of 1 mL of Carboprost Sterile Solution (containing the equivalent of 250 micrograms of carboprost) is to be administered deep in the muscle with a tuberculin syringe. Subsequent doses of 250 micrograms should be administered at 1½ to 3½ hour intervals depending on uterine response.
An optional test dose of 100 micrograms (0.4 mL) may be administered initially. The dose may be increased to 500 micrograms (2 mL) if uterine contractility is judged to be inadequate after several doses of 250 micrograms (1 mL).
The total dose administered of carboprost tromethamine should not exceed 12 milligrams and continuous administration of the drug for more than two days is not recommended.
For Refractory Postpartum Uterine Bleeding: An initial dose of 250 micrograms of Carboprost Sterile Solution (1 mL of Carboprost) is to be given deep, intramuscularly. In clinical trials it was found that the majority of successful cases (73%) responded to single injections. In some selected cases, however, multiple dosing at intervals of 15 to 90 minutes was carried out with successful outcome. The need for additional injections and the interval at which these should be given can be determined only by the attending physicians as dictated by the course of clinical events. The total dose of Carboprost should not exceed 2 milligrams (8 doses).
",,"Carboprost may augment the activity of other oxytocic agents. Concomitant use with other oxytocic agents is not recommended.
","
+- Hypersensitivity (including anaphylaxis and angioedema) to Carboprost Sterile Solution
+- Acute pelvic inflammatory disease
+- Patients with active cardiac, pulmonary, renal or hepatic disease
+
","The most frequent adverse reactions observed are related to its contractile effect on smooth muscle, especially gastrointestinal effects like vomiting, nausea, diarrhea and pyrexia. Endometritis, retained placental fragments, and excessive uterine bleeding occurred as the most common complications after abortion with Carboprost.
","Pregnancy category C. Animal studies do not indicate that Carboprost is teratogenic, however, it has been shown to be embryotoxic in rats and rabbits and any dose which produces increased uterine tone could put the embryo or fetus at risk.
","
+- Use Carboprost by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities.
+- Use Carboprost cautiously in patients with a history of asthma, hypo- or hypertension, cardiovascular, renal or hepatic disease, anemia, jaundice, diabetes or epilepsy and compromised (scarred) uteri.
+- In few patients with chorioamnionitis, uterus may not respond to Carboprost.
+- Cervix should always be carefully examined immediately post-abortion.
+
",,,,,,9
+204,Carboplatin,carboplatin-204,https://medex.com.bd/attachments/bBXZWMJbBT4cefBFF3GfJk4zScWN8O/carboplatin-prescribing-information,Cytotoxic Chemotherapy,Stomach carcinoma,"Initial Treatment of Advanced Ovarian Carcinoma: Carboplatin is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimenconsists of Carboplatin and cyclophosphamide. ... Read more
Initial Treatment of Advanced Ovarian Carcinoma: Carboplatin is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimenconsists of Carboplatin and cyclophosphamide. Two randomizedcontrolled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups.
There is limited statistical power to demonstrate equivalence in overal pathologic complete response rates and long-term survival ( ≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.
Secondary Treatment of Advanced Ovarian Carcinoma: Carboplatin is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin.
Within the group of patients previously treated with cisplatin, those who have developed progressive disease while receiving cisplatin therapy may have a decreased response rate.
","Cytotoxic Chemotherapy
","Carboplatin is an alkylating agent which binds covalently to DNA. It modifies the cell cycle by interfering with DNA structure and function.
","Previously untreated patients: 400 mg/m2 as single short term IV infusion over 15-60 min. Therapy should not be repeated until 4 wk after the previous course and/or until the neutrophil count is at least 2,000 cells/mm3 and the platelet count is at least 100,000 cells/mm3.
Patients previously treated with myelosuppresive therapy or patients with poor performance status: Reduce initial dosage by 20-25% (300-320 mg/m2).
",,"Administration of a liver vaccine may be dangerous during treatment with carboplatin. The renal effects of nephrotoxic compounds may be potentiated by carboplatin.
","Carboplatin injection should not be employed in patients with severe bone marrow depression or significant bleeding. It is contraindicated in patients with a history of severe allergic reactions to cisplatin or other platinum containing compounds.
","Bone marrow suppression, gastrointestinal effects, nephrotoxicity, nervous system, ototoxicity, allergic reactions, alopecia, mucositis.
","Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk
","Much less renal toxicity than cisplatin so no need for a vigorousm hydration schedule or forced diuresis. If AUC dosing is not used, dose should be reduced to 250 mg/m2 for creatinine clearance of 41 to 59 ml/min and to 200 mg/m2 for clearance of 16 to 40 ml/min. Corticosteroids & antihistamines are employed to alleviate symptoms.
","Renal Impairment:
+
+- CrCl (16-40 ml/min)- 200 mg/m2.
+- CrCl (41-59 ml/min)- 250 mg/m2.
+
",,,"150 mg injection should be reconstituted with 15 ml of sodium chloride solution (0.9%) or water for injection.
450 mg injection should be reconstituted with 45 ml of sodium chloride solution (0.9%) or water for injection.
The reconstituted solution should be diluted by 300 ml (for 150 mg) & 900 ml (for 450 mg) of 5% glucose for injection or 0.9% sodium chloride solution for infusition.
","Store at 25° C. Protect from light.
",12
+203,Carbonyl Iron + Folic Acid + Zinc Sulfate + Vitamin B Complex + Vitamin C,carbonyl-iron-folic-acid-zinc-sulfate-vitamin-b-complex-vitamin-c-203,,"Iron, Vitamin & Mineral Combined preparation",Vitamin or mineral supplement,"This capsule is indicated for the treatment and prophylaxis of iron, folic acid, zinc, vitamin-B complex and vitamin-C deficiency, especially during pregnancy and lactation.
","Iron, Vitamin & Mineral Combined preparation
","
+- Carbonyl Iron is more effective and safer choice of Iron supplementation as it has higher bioavailability, low toxicity and better Gl tolerance.
+- Folic acid is required to maintain normal healthy development of the neural tube and is vital for cell division from a single cell to a fully developed baby.
+- Vitamin B Complex is required for the growth and development of unborn babies.
+- Vitamin C plays a role In the structure of collagen in the fetal membrane.
+- Zinc is a critical nutrient for fetal growth & development, central nervous system development & function and ensures better maternal & infant health
+
","Adult: One capsule daily before food or as directed by the physician.
Use in Children & Adolescents: Upon consultation with a doctor, recommended to use in children & adolescents.
",,"Carbonyl Iron decreases the absorption of tetracycline antibiotics, quinolone antibiotics, levodopa, levothyroxine, methyldopa and penicillamine. Folic Acid interacts with antiepileptics, so plasma concentrations of phenobarbital, phenytoin and primidone are possibly reduced.
","It is contraindicated in patients with a known hypersensitivity to any of the ingredients. Iron therapy is contraindicated in the presence of haemolytic anaemia.
","Allergic sensitization has been reported following oral administration of Folic acid. Oral iron preparation may cause constipation, particularly in older patients.
","Use of any drug during first trimester of pregnancy should be avoided if possible. Thus administration of Iron during the first trimester requires definite evidence of Iron deficiency. Prophylaxis of Iron deficiency where inadequate diet calls for supplementary Zinc and Folic acid is justified during the remainder of the pregnancy.
","Care should be taken in patients who may develop iron overload, such as those with hemochromatosis, hemolytic anemia or red cell aplasia. Iron chelates with tetracycline and absorption may be impaired.
",,"Symptoms of Carbonyl Iron include decreased energy, nausea, abdominal pain, tarry stool, weak, rapid pulse, fever, coma, seizures.
",,,"Store at temperature not exceeding 30°C in a dry place. Protect from moisture.
",11
+202,Carbonyl Iron + Folic Acid + Zinc Sulfate,carbonyl-iron-folic-acid-zinc-sulfate-202,,"Iron, Vitamin & Mineral Combined preparation",Pregnancy,"It is indicated for the treatment and prophylaxis of Iron, Folic Acid and Zinc deficiency especially during pregnancy and lactation.
","Iron, Vitamin & Mineral Combined preparation
","This timed-release capsule is the combined preparation of Carbonyl Iron, Folic Acid and Zinc Sulphate Monohydrate. It contains Carbonyl Iron with not less than 98% Iron content. Carbinyl Iron, having high bioavailability and low toxicity is safer and more effective choice for iron supplementation.
","Adult: One Capsule daily before food or as directed by the physician.
",,"Carbonyl Iron decreases the absorption of tetracycline antibiotics, quinolone antibiotics, levodopa, levothyroxine, methyldopa and penecillamine. Folic Acid interacts with antiepileptics, so plasma concentrations of phenobarbital, phenytoin and primidone are possibly reduced.
","It is contraindicated in patients with known hypersensitivity to any of its component or those with Iron overload.
","Gastrointestinal irritations such as nausea, anorexia, vomiting, discomfort, constipation and diarrhoea may occur. Patients may complain of dark stool. Carbonyl Iron pellets incorporated into the capsules to reduce the possibility of gastrointestinal irritations. Rarely there may be allergic reactions.
","Use of any drug during first trimester of pregnancy should be avoided if possible. Thus administration of Iron during the first trimester requires definite evidence of Iron deficiency. Prophylaxis of Iron deficiency where inadequate diet calls for supplementary Zinc and Folic acid is justified during the remainder of pregnancy.
","Special care should be taken in patients with Iron overload states, such as haemochromatosis, haemolytic anaemia or red blood cell aplasia. Failure to response to the treatment requires further investigations to exclude other causes of anaemia. In patients with renal failure there may be the risk of Zinc accumulation.
",,"Symptoms of Carbonyl Iron include decreased energy, nausea, abdominal pain, tarry stool, weak, rapid pulse, fever, coma, seizures.
",,,"Store below 30°C. and keep away from light and moisture. Keep all medicines out of the reach of children.
",11
+244,Carbonyl Iron + Folic Acid,carbonyl-iron-folic-acid-244,,Iron & Vitamin Combined preparations,Pregnancy,"This capsule is used for the treatment, control, prevention, & improvement of the following diseases, conditions and symptoms:
+
+- Iron deficiency
+- Treatment of megaloblastic anemias due to a deficiency of folic acid
+- Treatment of anemias of nutritional origin, pregnancy, infancy, or childhood
+- This may also be used for purposes not listed here.
+
","Iron & Vitamin Combined preparations
","This capsule is used for Iron deficiency, Treatment of megaloblastic anemias due to a deficiency of folic acid, Treatment of anemias of nutritional origin, Pregnancy, Infancy, Or childhood and other conditions. This capsule may also be used for purposes not listed in this medication guide.
This capsule contains Carbonyl Iron and Folic Acid as active ingredients. It works by producing red blood cells as well as transporting oxygen in the body; acting on megaloblastic bone marrow to produce a normoblastic marrow.
","One capsule daily. In more severe cases, 2 capsules a day may be required or as directed by the physician.
",,"If you use other drugs or over the counter products at the same time, the effects of this capsule may change. This may increase your risk for side-effects or cause your drug not to work properly. Tell your doctor about all the drugs, vitamins, and herbal supplements you are using, so that you doctor can help you prevent or manage drug interactions. It may interact with the following drugs and products:
+
+- Alcohol
+- Antibiotics
+- Barbiturates
+- Bisphosphonates
+- Diphenylhydantoin
+- Levodopa
+- Levothyroxine
+- Methotrexate
+- Methyldopa
+- Nitrofurantoin
+
","Hypersensitivity to this capsule is a contraindication. In addition, this capsule should not be used if you have the following conditions: Hypersensitivity, Intolerance to the drug.
","The following is a list of possible side-effects that may occur from all constituting ingredients of this capsule. This is not a comprehensive list. These side-effects are possible, but do not always occur. Some of the side-effects may be rare but serious. Consult your doctor if you observe any of the following side-effects, especially if they do not go away.
+
+- Constipation
+- Diarrhea
+- Stomach cramps
+- Upset stomach
+- Allergic reactions
+- Anorexia
+- Nausea
+- Abdominal distention
+- Flatulence
+- Bitter or bad taste
+- Altered sleep patterns
+- Difficulty in concentrating
+- Irritability
+
",,"Before using this capsule, inform your doctor about your current list of medications, over the counter products (e.g. vitamins, herbal supplements, etc.), allergies, pre-existing diseases, and current health conditions (e.g. pregnancy, upcoming surgery, etc.). Some health conditions may make you more susceptible to the side-effects of the drug. Take as directed by your doctor or follow the direction printed on the product insert. Dosage is based on your condition. Tell your doctor if your condition persists or worsens. Important counseling points are listed below.
+
+- Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient
+- Avoid alcohol consumption, especially if having alcoholic cirrhosis
+- Avoid taking antacids within 2 hours while taking this medicine
+- Do not take this medicine if you have too much iron builds
+- Folic acid in doses above 0.1 mg daily may obscure the diagnosis of pernicious anemia
+- Pregnant, planning to become pregnant or breastfeeding
+- Risk of obscuring the diagnosis of pernicious anemia
+- Take this medicine without meal
+- Vitamin B12 is use to treat pernicious anemia
+
",,,,,"Store medicines at room temperature, away from heat and direct light. Do not freeze medicines unless required by package insert. Keep medicines away from children.
",9
+201,Carbocisteine,carbocisteine-201,https://medex.com.bd/attachments/uykFKYVyB5X9b9CTGKQWWSvWwiAeNs/carbocisteine-capsule-prescribing-information,Cough expectorants & mucolytics,Mucolytic,"Carbocisteine is indicated for- Acute bronchitis, Chronic bronchitis, Bronchial asthma, Upper respiratory tract inflammation (pharyngitis, laryngitis), Cystic fibrosis Bronchiectasis, Pulmonary tuberculosis, Drainage in chronic sinusitis and pneumonia, Drainage in otitis media in children.
","Cough expectorants & mucolytics
","Carbocisteine reduces goblet cell hyperplasia and therefore plays a role in the management of disorders characterised by abnormal mucous. Carbocisteine loosens thick sputum effectively by reducing its viscosity and thereby helps to expectorate that mucus more easily from the respiratory tract. The mucolytic action happens in several mechanisms. It breaks the disulphide bonds, which cross-link certain glycoprotein molecules in the mucus, the mucus produced under the influence of Carbocisteine has high sialomucin and low fucomucin content. This combined effect ultimately reduces the viscosity of the sputum and increases its volume.
","Adult: Initially, 2.25 g daily in divided doses, then 1.5 g daily in divided doses as condition improves.
Child: 2-5 year: 62.5-125 mg 4 times daily; 6-12 year 250 mg tid.
Should be taken with food.
",,"Neither hazardous nor therapeutically useful interactions have been reported.
","Contraindicated in active peptic ulceration and in patients with hypersensitivity to the drug.
","Gastrointestinal discomfort, nausea, diarrhoea, gastrointestinal bleeding, palpitation, dizziness, headache, heartburn and skin rash may occur.
","There is no information on the use of Carbocisteine during lactation. While there are no reports of teratogenic effects, the manufacturers do not recommend the use of Carbocisteine in the first trimester.
","No specific precaution is recommended but Carbocisteine should be used with caution in patients with a recent history of peptic ulcer and recurrent gastrointestinal bleeding.
",,"Symptoms: GI disturbance.
Management: May perform gastric lavage, followed by observation.
",,,"Store in a cool and dry place protected from light.
",11
+200,Carbimazole,carbimazole-200,https://medex.com.bd/attachments/QfouuBKMJiguJBhMvzcI68u9ISBvzu/carbimazole-prescribing-information,Anti-thyroid drugs,Thyrotoxicosis,"Carbimazole is indicated in the management of hyperthyroidism, thyrotoxicosis (including thyroid storm), and also for the preparation of patients for thyroidectomy. Carbimazole can also be used in combination with radio-active ablative therapy
","Anti-thyroid drugs
","Carbimazole is metabolised to thiamazole which is responsible for its antithyroid action. It blocks the production of thyroid hormones through inhibition of the organification of iodide and the coupling of iodothyronine residues.
","10 mg to 60 mg daily according to the severity of the disorder. The dose should be gradually reduced to the smallest amount which will control the disease. Daily dosage should be divided.
",,"Carbimazole may interact adversely with other medicines. Iodine or iodine excess may decrease the response to Carbimazole, requiring an increase in dosage or longer duration of therapy with antithyroid agents. As thyroid and metabolic status of patient decreases toward normal, response to oral anticoagulants may decrease, however, if thioamide-induced hypoprothrombinemia occurs, anticoagulant effects may be enhanced. Adjustment of oral anticoagulant dosage on the basis of prothrombin time is recommended. Serum concentrations of digoxin and digitoxin have been reported to increase as the thyroid and metabolic status of patients taking antithyroid agents decreased, reduction in dosage of any digitalis glycoside may be necessary as patients become euthyroid.
","Hypersensitivity to carbimazole or other thiourea antithyroid agents
","Nausea, headache, arthralgia, fever, jaundice, malaise, mild gastric distress, skin rashes, pruritus, taste disturbance; bone marrow depression including neutropenia, eosinophilia, leucopenia. Rarely, pancytopenia/aplastic anaemia and isolated thrombocytopenia, haemolytic anaemia.
","Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk
","Caution should be taken in patients with intrathoracic goitre. Mild to moderate hepatic impairment. Caution also should be taken in children, pregnancy and lactation.
",,"Overdose or accidental poisoning may result in hypothyroidism and goitre. If blood dyscrasias occur, the drug should be immediately withdrawn. Further treatment is symptomatic and supportive.
",,,"Store below 25° C.
",11
+197,Carbetocin,carbetocin-197,https://medex.com.bd/attachments/FODMtL4SzmBvpab8JApXRUztckdQ8L/carbetocin-prescribing-information,Drugs acting on the Uterus,Uterine atony,"Carbetocin is indicated for the prevention of uterine atony and postpartum haemorrhage (excessive bleeding) following delivery of the infant by elective caesarean section under epidural or spinal anaesthesia.
","Drugs acting on the Uterus
","Carbetocin is a drug used to control postpartum hemorrhage, bleeding after giving birth. It is an analogue of oxytocin, and its action is similar to that of oxytocin; it causes contraction of the uterus. Carbetocin binds to oxytocin receptors present on the smooth musculature of the uterus, resulting in rhythmic contractions of the uterus, increased frequency of existing contractions, and increased uterine tone. The oxytocin receptor content of the uterus is very low in the non-pregnant state, and increases during pregnancy, reaching a peak at the time of delivery.
","A single intravenous dose of 100 mcg of carbetocin injection is administered by bolus injection, slowly over 1 minute, only when infant delivery has been completed by caesarean section under epidural or spinal anaesthesia. carbetocin is to be used as a single dose only.
",,"No specific drug interactions have been reported with carbetocin.
","Because of its long duration of action relative to oxytocin, uterine contractions produced by carbetocin cannot be stopped by simply discontinuing the medication. Therefore, carbetocin should not be administered prior to delivery of the infant for any reason, including elective or medical induction of labour. Inappropriate use of carbetocin during pregnancy could theoretically mimic the symptoms of oxytocin overdosage, including hyperstimulation of the uterus with strong (hypertonic) or prolonged (tetanic) contractions, tumultuous labour, uterine rupture, cervical and vaginal lacerations, postpartum haemorrhage, utero-placental hypoperfusion and variable deceleration of foetal heart, foetal hypoxia, hypercapnia, or death. Carbetocin should not be used in patients with a history of hypersensitivity to oxytocin or carbetocin. Carbetocin should not be used in patients with cardio vascular disease, especially coronary artery disease, valvular heart disease, cardiomyopathy and heart failure. Carbetocin is not intended for use in children.
","10-40% of patients experienced nausea, vomiting, abdominal pain, itching skin, increased body temperature, trembling and weakness. Infrequent adverse events (1-5% of patients) included back pain, dizziness, metallic taste, anaemia, sweating, chest pain, dyspnoea, chills, tachycardia and anxiety.
","Use of carbetocin injection is contraindicated during pregnancy. Small amounts of carbetocin has been shown to cross over from plasma into the breast milk of nursing women. The small amount of carbetocin ingested by infant would not be expected to present a significant safety concern.
","
+- In patients who may not have an adequate uterine contraction after a single injection of carbetocin, more aggressive treatment with additional doses of oxytocin or ergometrine is warranted.
+- As carbetocin is closely related in structure to oxytocin, hyponatraemia may occur.
+- Carbetocin should be used cautiously in the presence of epilepsy, migraine, asthma or any state in which a rapid addition to extracellular water may produce hazard for an already overburdened system.
+- Patients with eclampsia and pre-eclampsia should be monitored for changes in blood pressure.
+- Carbetocin is not recommended for use in elderly patients.
+
",,"Overdosage of carbetocin can be expected to produce enhanced pharmacological effects associated with uterine hyperactivity and pain. Treatment consists of symptomatic and supportive management.
",,,"Store at 2-8°C. Do not freeze. Keep away from light. Once the ampoule has been opened, the product should be used immediately.
",11
+196,Carbamazepine,carbamazepine-196,https://medex.com.bd/attachments/gDeaZVOUhYqGpXGmTOj7xKipG2c2IB/carbamazepine-prescribing-information,Primary anti-epileptic drugs,Unipolar and bipolar depression,"Carbamazepine is indicated for-
+
+- partial and secondary generalized tonic-clonic seizures
+- Primary generalized tonic-clonic seizures
+- Trigeminal neuralgia
+- Prophylaxis of bipolar disorder
+
","Primary anti-epileptic drugs
","Carbamazepine depresses activity in the nucleus ventralis of the thalamus, reduces synaptic propagation of excitatory impulses or decreases summation of temporal stimulation leading to neural discharge by limiting influx of Na ions across cell membrane or other unknown mechanisms. It stimulates the release of antidiuretic hormone (ADH) and potentiates its action in promoting reabsorption of water.
","Epilepsy:
+
+- Adults and children over 12 years of age- Initial: Either 200 mg b.i.d. for tablets and controlled release tablets, or 1 teaspoon q.i.d. for suspension (400 mg/day). Increase at weekly intervals by adding up to 200 mg/day using a b.i.d or a t.i.d. or q.i.d. regimen of the either formulations until the optimal response is obtained.
+- Children 12-15 years of age- Dosage generally should not exceed 1000 mg daily, and 1200 mg daily in patients above 15 years of age. Doses up to 1600 mg daily have been used in adults in rare instances. Maintenance: usually 800-1200 mg daily.
+- Children 6-12 years of age- Initial: Either 100 mg b.i.d. for tablets or controlled release tablets, or 1/2 teaspoon q.i.d. for suspension (200 mg/day). Increase at weekly intervals by adding up to 100 mg/day using a b.i.d. or a t.i.d.or q.i.d. regimen of the either formulations until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily. Maintenance:usually 400-800 mg daily.
+- Children under 6 years of age- Initial: 10-20 mg/kg/day b.i.d.or t.i.d. as tablets, or q.i.d. as suspension. Increase weekly to achieve optimal clinical response administered t.i.d. or q.i.d. Maintenance: Ordinarily, optimal clinical response is achieved at daily doses below 35 mg/kg. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the therapeutic range. No recommendation regarding the safety of Carbamazepine for use at doses above 35 mg/kg/24 hours can be made.
+
+
Combination therapy: Carbamazepine may be used alone or with other anticonvulsants. When added to existing anticonvulsant therapy, the drug should be added gradually while the other anticonvulsants are maintained or gradually decreased, except phenytoin, which may have to be increased.
Trigeminal Neuralgia: Initial: On the first day,either 100 mg b.i.d. for tablets or controlled release tablets, or 1/2 teaspoon q.i.d. for suspension, for a total daily dose of 200 mg. This daily dose may be increased by up to 200 mg/day using increments of 100 mg every 12 hours for tablets or controlled release tablets, or 50 mg (1/2 teaspoon) q.i.d. for suspension, only as needed to achieve freedom from pain. A total dose of 1200 mg daily shouldn't be exceeded. Maintenance: Control of pain can be maintained in most patients with 400-800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even to discontinue the drug. The tablets or syrup can be taken without regards to meal.
",,"Galactorrhoea has been reported in few women on oral contraceptives within the first two months of Carbamazepine treatment Hepatic enzyme inducers such as Carbamazepine and Phenytoin may interact with Carbamazepine by increasing its metabolism. So an increase in dosage of Carbamazepine may be required.
","This medicine should not be used if anybody is allergic to one or any of its ingredients. It can not be used also in the following conditions:
+
+- Problems with the electrical message pathways in the heart (atrioventricular block)
+- History of decreased blood cell production by the bone marrow (bone marrow depression)
+- Hereditary blood disorders called porphyrias
+- Allergy to tricyclic antidepressants
+- People who have taken a monoamine-oxidase inhibitor antidepressant (MAOI) in the last 14 days
+
","The common side effects are dizziness, drowsiness, ataxia, dry mouth, abdominal pain, nausea, vomiting, anorexia, leucopenia, proteinuria, bradycardia, heart failure and hypotension. Erythematous skin rash, aplastic anemia may also be observed.
The most severe adverse reactions have been observed in the hemopoietic system, the skin and the cardiovascular system.The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. This medicine may cause increased sensitivity to the sun. Exposure to the sun, sunlamps, or tanning booths should be avoided if the increased sensitivity is seen. A sunscreen or protective clothing may be helpful at outside for a prolonged period.
","Pregnancy category D. Carbamazepine and its epoxide metabolite are transferred to breast milk. Because of the potential serious side effects, decision should me made whether to discontinue nursing or discontinue the drug.
","This medicine may cause dizziness and drowsiness.Special care should be taken while performing potentially hazardous activities, such as driving or operating machinery.
This medicine may cause skin reactions. If any rash,skin peeling, itching, or other unexplained skin reaction is seen while taking this medicine the concerned doctor should be informed immediately.
This medicine may rarely cause liver problems.For this reason, consultation with doctor is needed if unexplained itching, yellowing of the skin or eyes, unusually dark urine, nausea and vomiting, abdominal pains, and loss of appetite or flu-like symptoms.
Carbamazepine decreases the blood levels of hormonal contraceptives containing estrogen and/or progesterone, which may make the contraceptive ineffective or result in breakthrough bleeding.
Women taking this medicine who require contraception should be prescribed a contraceptive containing at least 50 micrograms of oestrogen,or use non-hormonal methods of contraception, such as condoms.
Taking this medicine should not be stopped suddenly unless the doctor tells. Otherwise, as suddenly stopping treatment is likely to make the symptoms return.If this medicine is stopped, it should normally be done gradually, under the supervision of a specialist.
Caution should be taken in-
+
+- Mixed seizures including absence seizures
+- Elderly people
+- History of heart disease
+- History of kidney disease
+- History of liver disease
+- History of psychotic illness
+- Raised pressure in the eye (intraocular pressure), eg.glaucoma
+- History of blood disorders that were caused by any other medication
+- History of previous Carbamazepine therapy that was interrupted due to side effects or allergy
+
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+195,Captopril,captopril-195,https://medex.com.bd/attachments/g8FRsxlP00N62AqoDf4wr8iqueziE4/captopril-prescribing-information,Angiotensin-converting enzyme (ACE) inhibitors,Myocardial infarction,"Hypertension: Mild to moderate hypertension as an adjunct to thiazide therapy in patients who have not responded effectively to thiazide treatment alone.
Severe hypertension: Where standard therapy has failed. Cardopril is effective alone or in combination ... Read more
Hypertension: Mild to moderate hypertension as an adjunct to thiazide therapy in patients who have not responded effectively to thiazide treatment alone.
Severe hypertension: Where standard therapy has failed. Cardopril is effective alone or in combination with other antihypertensive agents especially thiazide type of diuretics. The blood pressure lowering effect of Cardopril and thiazides are approximately additive.
Congestive heart failure: It is also used as an adjunct to the treatment of severe congestive heart failure.
","Angiotensin-converting enzyme (ACE) inhibitors
","Captopril competitively inhibits the conversion of angiotensin I (ATI) to angiotensin II (ATII), thus resulting in reduced ATII levels and aldosterone secretion. It also increases plasma renin activity and bradykinin levels. Reduction of ATII leads to decreased Na and water retention. This promotes vasodilation and BP reduction.
","Diabetic nephropathy:
+
+- Adult: Type 1 diabetics: 75-100 mg/day in divided doses.
+
+
Post-myocardial infarction:
+
+- Adult: May be started 3-16 days after MI. Initially, 6.25 mg/day followed by 12.5 mg tid for 2 days, then 25 mg tid. Maintenance: 75-150 mg/day in 2 or 3 divided doses.
+
+
Hypertension:
+
+- Adult: Initially, 12.5 mg bid, 1st dose preferably at bedtime to avoid precipitous fall in BP, gradually increased at 2-4-wk intervals according to response. Maintenance: 25-50 mg bid. Max: 50 mg tid. Patients on diuretics: 6.25 mg bid.
+- Child: Neonates and infants: 0.15 mg/kg. Max: 6 mg/kg in 2 or 3 divided doses according to response. Childn and adolescents: 0.3 mg/kg. Max: 6 mg/kg in 2 or 3 divided doses according to response.
+- Elderly: Initially, 6.25 mg bid.
+
+
Heart failure:
+
+- Adult: Initially, 6.25-12.5 mg bid or tid. Maintenance: 25 mg bid or tid. Max: 50 mg tid.
+- Child: Initially, 0.25 mg/kg/day, increased up to 2.5 or 3.5 mg/kg/day in 3 divided doses.
+
",,"Concurrent treatment with NSAIDs reduces hypotensive action and increases the risk of nephrotoxicity. Additive hyperkalaemic effect with K supplements, K-sparing diuretics, and other drugs (e.g. heparin). May increase risk of leucopenia with procainamide, allopurinol, cytostatic or immunosuppressants. May increase risk of lithium toxicity. Increased risk of nitritoid reactions with gold (Na aurothiomalate).
","Angioedema related to previous ACE inhibitor treatment, hereditary or idiopathic angioneurotic oedema. Concomitant use with aliskiren in diabetic patients. Pregnancy.
","Neutropenia, anaemia and thrombocytopenia; proteinuria, elevated blood urea and creatinine, elevated serum potassium and acidosis; hypotension, tachycardia; rashes usually pruritic, may occur; Reversible and usually self limiting taste impairment has been reported. Stomatitis resembling aphthous ulcers has also been reported.
","Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk
","Patients with bilateral renal artery stenosis, collagen vascular disease, aortic or mitral valve stenosis, volume and/or Na depletion. Renal impairment. Lactation.
",,"Symptoms: Severe hypotension, shock, stupor, bradycardia, electrolyte disturbances and renal failure.
Management: Perform gastric lavage, administer adsorbent and sodium sulfate with in 30 min of ingestion; NaCl 0.9% IV infusion. Treatment with angiotensin-II may also be considered. Administer atropine in case of extensive vagal reactions or bradycardia. Pacemaker is also an option. Elimination may be enhanced by haemodialysis.
",,,"Store below 30° C
",11
+194,Capsaicin,capsaicin-194,https://medex.com.bd/attachments/xTbMM9KTx3wpdzmcUe0t40NgIQyth2/capsaicin-prescribing-information,Topical Analgesics,Trigeminal neuralgia,"Capsaicin is indicatd for- Rheumatoid arthritis, Osteoarthritis, Pain due to diabetic neuropathy, Joint pain, Post-herpetic neuralgia, Post-surgical neuropathic pain, Nerve Pain, Back pain, Muscle pain, Fibromyalgia, Bursitis, Pruritis (itching)
","Topical Analgesics, Topical anti-inflammatory preparations
","Although the precise mechanism of action of Capsaicin is not fully understood, current evidence suggests that Capsaicin exerts an analgesic effect by depleting and preventing reaccumulation of Substance P in peripheral sensory neurons. Substance P is thought to be the principal chemomediator of pain impulses from the periphery to the central nervous system.
","18 years of age and older: Apply a thin film of Capsaicin cream to affected area 3 to 4 times daily. A burning sensation may occur upon application, but generally disappears with regular use. Application schedules of 3 to 4 times a day for 2 weeks provides optimum pain relief.
",,,"Capsaicin cream is contraindicated on broken or irritated skin. It is also contraindicated in patients with known hypersensitivity to capsaicin or any of the excipients used in this product.
","Capsaicin may cause transient burning on application. This burning is observed more frequently when the application schedules are more than 3-4 times daily. The burning can be enhanced if too much cream is used and if it is applied just before or after a bath or shower.
","The safety of Capsaicin during pregnancy or lactation has not been established in either humans or animals.
","Capsaicin cream should not be applied to broken or irritated skin. Applied area should not be tightly bandaged. Do not get on mucous membranes and into eyes or on contact lenses. If this occurs, rinse the affected area thoroughly with water. Do not apply the cream on the heat treated area as this may increase the burning sensation. In case of accidental ingestion, seek physician advice immediately.
",,"Sufficient information on overdose of Capsaicin is not available.
",,,"Keep at cool and dry place, away form light. Keep out of the reach of children.
",10
+247,Caprylic + Capric Triglyceride,caprylic-capric-triglyceride-247,https://medex.com.bd/attachments/m4e6VrFbFOzSM4tqpxkeHjJoeEBOVo/caprylic-capric-triglyceride-prescribing-information,Emollients & combined preparations,"Repairs, restores & protects dry skin & sensitive skin conditions","Repairs, restores & protects dry skin & sensitive skin conditions
","Emollients & combined preparations
","With physiological lipids to protect & maintain healthy skin.The Derma Membrane Structure (DMS) base, used uniquely in Physiogel products, is made up of natural lipids similar to the skin's (epidermis) physiologic lipids which are natural and essential components of normal healthy skin, hence, revitalizes very dry, irritated and sensitive skin or helps retain skin moisture and prevents skin dryness, thus, regenerates the skin lipid barrier, reduces water loss and provides protection against environmental triggers.
","Cream: Apply a thin film once or bd on hands, face & particularly dry areas.
Lotion: Apply once or bd. Ideal for the entire body.
",,"There are no known drug interactions and none well documented.
","Hypersensitivity.
","Some possible side effects and reactions include rash, redness and itchiness.
","Pregnancy Category - Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
","Discontinue use and consult a dermatologist if undue irritation develops or increases. Avoid contact with eyes or mucous membranes. In case of contact, rinse thoroughly with water.
",,,,,,9
+193,Capecitabine,capecitabine-193,https://medex.com.bd/attachments/JUjeUrsnaOMtKIvQMfefkxL7TFK4Aa/capecitabine-prescribing-information,Cytotoxic Chemotherapy,Carcinoma of the colon or rectum,"Capecitabine is a nucleoside metabolic inhibitor with antineoplastic activity indicated for:
+
+- Adjuvant Colon Cancer: Patients with Dukes'C colon cancer.
+- Metastatic Colorectal Cancer: First-line as monotherapy when treatment with fluoropyrimidine therapy alone is preferred.
... Read more
Capecitabine is a nucleoside metabolic inhibitor with antineoplastic activity indicated for:
+
+- Adjuvant Colon Cancer: Patients with Dukes'C colon cancer.
+- Metastatic Colorectal Cancer: First-line as monotherapy when treatment with fluoropyrimidine therapy alone is preferred.
+- Metastatic Breast Cancer: In combination with docetaxel after failure of prior anthracycline containing therapy.
+- As monotherapy in patients resistant to both paclitaxel and an anthracycline-containing regimen.
+
","Cytotoxic Chemotherapy
","Capecitabine is a preparation of Capecitabine, an orally-administered chemotherapeutic agent used in the treatment of cancers. Capecitabine is a prodrug, that is enzymatically converted to fluorouracil (antimetabolite) in the tumour, where it inhibits DNA synthesis and slows growth of tumour tissue.
Capecitabine is a prodrug that is selectively tumour-activated to its cytotoxic moiety, fluorouracil, by thymidine phosphorylase, an enzyme found in higher concentrations in many tumours compared to normal tissues or plasma. Fluorouracil is further metabolized to two active metabolites, 5-fluoro-2'-deoxyuridine 5-monophosphate (FdUMP) and 5-fluorouridine triphosphate (FUTP), within normal and tumour cells. These metabolites cause cell injury by two different mechanisms. First, FdUMP and the folate cofactor, N5-10 methylenetetrahydrofolate, bind to thymidylate synthase (TS) to form a covalently bound ternary complex. This binding inhibits the formation of thymidylate from 2-deoxyuridylate. Thymidylate is the necessary precursor of thymidine triphosphate, which is essential for the synthesis of DNA, therefore a deficiency of this compound can inhibit cell division. Secondly, nuclear transcriptional enzymes can mistakenly incorporate FUTP in place of uridine triphosphate (UTP) during the synthesis of RNA. This metabolic error can interfere with RNA processing and protein synthesis through the production of fraudulent RNA.
","Monotherapy: 1250 mg/m2 twice daily orally for 2 weeks followed by a one-week rest period in 3-week cycles
Adjuvant treatment: Is recommended for a total of 6 months (8 cycles)
In combination with docetaxel: The recommended dose of Capecitabine is 1250 mg/m2 twice daily for 2 weeks followed by a 7-day rest period, combined with docetaxel at 75 mg/m2 as a 1-hour IV infusion every 3 weeks. Capecitabine dosage may need to be individualized to optimize patient management. Capecitabine dosage has to be reduced by 25% in patients with moderate renal impairment.
Example: A person whose body weight is 64 kg and height is 1.64 m has a body surface area of 1.7 m2 and should take 4 tablets of 500 mg and 1 tablet of 150 mg two times daily.
The tablets should be taken in morning and evening as prescribed by doctor. The tablets should be taken within 30 minutes after the end of a meal (breakfast and dinner) and swallowed whole with water. Tablets should not be cut or crushed. Capecitabine should only be prescribed by a doctor experienced in the use of anticancer medicines.
",,"
+- Anticoagulants: Anticoagulant response (INR or prothrombin time) should be monitored frequently in order to adjust the anticoagulant dose as needed.
+- Phenytoin: Phenytoin levels should be monitored in patients taking Capecitabine concomitantly with phenytoin. The phenytoin dose may need to be reduced.
+- Leucovorin: The concentration of 5-fluorouracil is increased and its toxicity may be enhanced by leucovorin.
+- CYP2C9 substrates: Care should be exercised when Capecitabine is co-administered with CYP2C9 substrates.
+- Food: Reduced both the rate and extent of absorption of Capecitabine.
+
","
+- Severe Renal Impairment
+- Hypersensitivity
+- leucopenia, neutropenia or thrombocytopenia
+- Severe reactions to fluoropyrimidine therapy
+- Complete DPD deficiency
+- Pregnant or breast-feeding
+
","Abdominal pain, Rash, dry or itchy skin, Tiredness, loss of appetite (anorexia), Diarrhea, Vomiting, Nausea, Stomatitis, Hand-and-foot skin-reaction, Fever, Infection, Chest pain, Steven-Johnson syndrome
","Pregnancy category D. Capecitabine can cause fetal harm. Women are advised of the potential risk to the fetus. It is not known whether Capecitabine is excreted in human breast milk.No studies have been conducted to assess the impact of Capecitabine on milk production or its presence in human breast milk. As the potential for harm to the nursing infant is unknown, breast-feeding should be discontinued while receiving treatment with Capecitabine and for 2 weeks after the final dose.
","Coagulopathy: Anticoagulant response should be monitored (e.g. INR) and anticoagulant dose must be adjusted accordingly. Otherwise may result in bleeding, death.
Diarrhea: Capecitabine treatment should be stopped immediately until diarrhea resolves or decreases to grade 1. Standard antidiarrheal treatments recommended. Otherwise may get severe.
Cardiotoxicity: Common in patients with a prior history of coronary artery disease.
Increased Risk of Severe or Fatal Adverse Reactions in Patients with Low or Absent Dihydropyrimidine Dehydrogenase (DPD) Activity: Capecitabine should be withhold or permanently discontinued in patients with evidence of acute early-onset or unusually severe toxicity, which may indicate near complete or total absence of DPD activity.
Dehydration and Renal Failure: Capecitabine treatment should be stopped until dehydration is corrected. Potential risk of acute renal failure secondary to dehydration.
Mucocutaneous and Dermatologic Toxicity: Severe mucocutaneous reactions, Steven-Johnson Syndrome. (SJS) and Toxic Epidermal Necrolysis (TEN), have been reported. Capecitabine should be permanently discontinued in patients who experience a severe mucocutaneous reaction during treatment. Capecitabine may induce hand-and-foot syndrome. Capecitabine treatment should be interrupted until the hand-and-foot syndrome event resolves or decreases in intensity.
Hyperbilirubinemia: Capecitabine treatment should be interrupted immediately until the hyperbilirubinemia resolves or decreases in intensity.
Hematologic: Patients should not be treated with neutrophil counts <1.5x109/L or thrombocyte counts <100x109/L.
",,"The manifestations of acute overdose include nausea, vomiting, diarrhea, mucositis, gastrointestinal irritation and bleeding, and bone marrow depression. Medical management of overdose should include customary therapeutic and supportive medical interventions aimed at correcting the presenting clinical manifestations and preventing their possible complications.
",,,"Keep in a dry place and store below 30°C. Protect from light and keep out of the reach of children.
",11
+192,Candesartan Cilexetil + Hydrochlorothiazide,candesartan-cilexetil-hydrochlorothiazide-192,https://medex.com.bd/attachments/9l4TupkQDJkFh9vpg3OsOi23lQjh0u/candesartan-cilexetil-hydrochlorothiazide-prescribing-information,Combined antihypertensive preparations,Hypertension,"This is indicated for the treatment of hypertension, congestive heart failure.
","Combined antihypertensive preparations
","Candesartan Cilexetil-Hydrochlorothiazide combines an angiotensin II receptor blocker, Candesartan Cilexetil and a diuretic, Hydrochlorothiazide.
Candesartan Cilexetil is an ester prodrug that is hydrolysed in the body to the active form Candesartan during absorption from the gastrointestinal tract. Candesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues (eg, vascular smooth muscle, adrenal gland).
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly by increasing sodium excreation. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume with consequent increase in plasma renin activity, aldosterone secretion, urinary potassium loss, and decrease in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so coadministration of Candesartan tends to reverse the potassium loss associated with Hydrochlorothiazide.
","The usual dose is one tablet once daily.
",,"No significant drug interactions have been reported for Candesartan Cilexetil with other drugs such as glyburide, nifedifine, digoxin, warfarin, hydrochlorothiazide and oral contraceptives. Alcohol, barbiturates, or narcotics- Potentiation of orthostatic hypotension may occur. Antidiabetic drugs (oral agents and insulin)- Dosage adjustment of the antidiabetic drug may be required. Other antihypertensive drugs- Additive effect or potentiation. Skeletal muscle relaxants, tubocurarine- Possible increased responsiveness to the muscle relaxant. NSAID can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics.
","Candesartan Cilexetil & Hydrochlorothiazide is contraindicated in patients who are hypersensitive to any component of this product. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
","Mild and transient in nature. The overall incidence of adverse events is comparable to placebo. Side effects are headache, upper respiratory tract infection, back pain, influenza-like symptoms.
","Use in pregnancy & lactation is not recommended.
","No patient receiving this combination was discontinued due to increases or decreases in serum potassium. Overall, the combination of candesartan cilexetil and hydrochlorothiazide had no clinically significant effect on serum potassium.
","Use in pediatric patient: Safety and effectiveness in pediatric patients have not been established.
",,,,,10
+191,Candesartan Cilexetil,candesartan-cilexetil-191,https://medex.com.bd/attachments/ttoDusG7G4iIMfGi7TOJVJ16ijV3HL/candesartan-cilexetil-prescribing-information,Angiotensin-ll receptor blocker,Hypertension,"Candesartan Cilexetil is indicated for hypertension, heart failure with impaired left ventricular systolic function.
","Angiotensin-ll receptor blocker
","Candesartan Cilexetil is an ester prodrug that is hydrolysed in the body to the active form Candesartan during absorption from the gastro-intestinal tract. Candesartan is angiotensin II receptor (type AT1) antagonist. Candesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues (eg, vascular smooth muscle, adrenal gland).
","Hypertention: initially 8 mg (hepatic impairment 2 mg, renal impairment or intravascular volume depletion 4 mg) once daily, increased if necessary at intervals of 4 weeks to max 32 mg once daily; usual maintenance dose 8 mg once daily.
Heart failure: initially 4 mg once daily, increased at intervals of at least 2 weeks to target dose of 32 mg once daily or to max tolerated dose.
",,"No significant drug interactions have been reported in studies of Candesartan Cilexetil given with other drugs such as glyburide, nifedipine, digoxin, warfarin, hydrochlorothiazide and oral contraceptives in healthy volunteers. Because candesartan is not metabolised by the cytochrome P-450 system and has no effects on P-450 enzymes, interactions with drugs that inhibit, or are metabolised by, those enzymes could not be expected.
","Hypersensitivity to any component of this product. Pregnancy, breast-feeding, cholestasis.
","Side-effects are usually mild. Symptomatic hypotension including dizziness may occur, particularly in patients with intravascular volume depletion (e.g. those taking high dose diuretics). Hyperkalemia occurs occassionally; angioedema has also been reported with some angiotension II receptor antagonist. Also vertigo, headache; rarely hepatitis, blood disorders, hyponatraemia, back pain, arthralgia, myalgia, rash, urticaria, pruritous.
","When pregnancy is detected, Candesartan Cilexetil should be discontinued as soon as possible. It should be used in lactation.
","Candesartan should be used with caution in renal artery stenosis, aortic or mitral valve stenosis and in obstructive hypertropic cardiomyopathy. Monitoring of plasma-potassium concentration is advised, particularly in the elderly and in patients with renal impairment; lower initial doses may be appropriate in these patients.
","Use in pediatric: Safety and effectiveness in pediatric patients have not been established.
",,,,"Store in a cool & dry place. Protect from light and moisture
",11
+245,Canagliflozin Hemihydrate,canagliflozin-hemihydrate-245,https://medex.com.bd/attachments/BjtIG3OpOIzuGmY7T9jYTap4oFDIEx/canagliflozin-hemihydrate-prescribing-information,Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors,Type 2 DM,"Canagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
","Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors
","Canagliflozin is an inhibitor of subtype-2 sodium-glucose co-transport protein (SGLT2), which is responsible for at least 90% of the glucose reabsorption in the kidney. Blocking this transporter reduces the reabsorption of glucose from renal tubules, leading to more excretion of glucose in urine.
","The recommended starting dose is 100 mg once daily, taken before the first meal of the day. Dose can be increased to 300 mg once daily who have CrCl>60 ml/min or who requires additional glycemic control. No dose adjustment is required for mild renal impairment. For moderate renal impairment (CrCl 45-60 ml/min) Canagliflozin 100 mg is recommended.
",,"UGT inducers (e.g. rifampin, phenytoin): Canagliflozin exposure is reduced. Consider increasing dose from 100 mg to 300 mg.
Digoxin: Canagliflozin may slightly increase the concentration of digoxin in the body when both drugs are being taken.
","History of serious hypersensitivity reaction to Canagliflozin, severe renal impairment, End Stage Renal Disease (ESRD), or on dialysis patients.
","The most common adverse reactions of Canagliflozin are female genital mycotic infections, urinary tract infection and increased urination. Other side effects of Canagliflozin include low blood pressure, increases potassium blood levels (hyperkalemia), low blood glucose and increases Low-Density Lipoprotein (LDL-C).
","Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. For nursing mother discontinue drug or nursing.
","Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
",,,,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",10
+246,Camphor + Menthol + Oil Clove + Oil Eucalyptus + Oil Turpentine,camphor-menthol-oil-clove-oil-eucalyptus-oil-turpentine-246,,Topical Analgesics,Strains,"Stiffness, Congestion, Muscle aches, Sprains, Strains, Back pain, Joint pain, Cold, Flu, Catarrh, Headache
","Topical Analgesics, Topical anti-inflammatory preparations
","Camphor acts as a cough suppressant & topical analgesic. Eucalyptus Oil acts as a cough suppressant. Menthol acts as a acts as cough suppressant & topical analgesic
","Topical: Rub gently 3-4 mintues on the chest and back 2-3 times daily. Cover the rubbed area with warm clothes.
Inhalation: 1 tsf of ointment to be dissolved in boiled water and inhale the steam by mouth or nose as required.
",,"There are no known drug interactions and none well documented.
","Children under 3 years. History of convulsion.
","Redness, irritation, rash or pruritis may occur with sensitive skin.
","Pregnancy Category-Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
","Avoid contact with eyes. Should not be applied to wounds or damaged skin. Wash hand thoroughly after applying.
",,,,,,9
+1574,Calcium Polystyrene Sulfonate,calcium-polystyrene-sulfonate-1574,https://medex.com.bd/attachments/K5mddVx4jfjrHdXwmcLMJd9XoImYQV/calcium-polystyrene-sulfonate-prescribing-information,Hyperkalaemia Products,Hyperkalemia,"Calcium Polystyrene Sulfonate is indicated in patients with hyperkalemia associated with anuria or severe oliguria. It reduces serum level of potassium and removes excess potassium from the body. Calcium Polystyrene Sulfonate is indicated in all states of hyperkalemia due to acute and chronic renal ... Read more
Calcium Polystyrene Sulfonate is indicated in patients with hyperkalemia associated with anuria or severe oliguria. It reduces serum level of potassium and removes excess potassium from the body. Calcium Polystyrene Sulfonate is indicated in all states of hyperkalemia due to acute and chronic renal failure, abortion, complicated labor, incompatible blood transfusion, crush injury, prostectomy, severe burns, surgical shock, cases of severe glomerulonephritis and pyelonephritis. Calcium Polystyrene Sulfonate can also be useful in patients requiring dialysis and can also be used during the period of under dialysis to control blood potassium levels.
","Hyperkalaemia Products
","Calcium Polystyrene Sulfonate acts by a cumulative process throughout the gastrointestinal tract, removing potassium ions which are excreted in the feces. Calcium Polystyrene Sulfonate passes through the colon and comes into contact with fluids containing increased amounts of potassium. The result is that potassium is taken up in increasing amounts in exchange for calcium ions. The length of time Calcium Polystyrene Sulfonate remains in the body is a decisive factor in its effectiveness. For this reason oral administration is more effective than rectal administration
","Calcium Polystyrene Sulfonate is for oral or rectal administration only. Treatment with the resin should be given as soon as the serum potassium level rises above 6 mmol/L.
Adults (Including the Elderly)-
+
+- Oral: For adults the usual dose is 15 g, 3 or 4 times a day. The resin is given by mouth as a suspension in a little water or for greater palatability, the resin may be made into a paste with some sweetened vehicle but not orange juice or other fruit juices that are known to contain potassium. The amount of fluid usually ranges from 3 to 4 ml for per gram of resin.
+- Rectal: In cases where oral administration is not possible Calcium Polystyrene Sulfonate may be given rectally as a suspension of 30 g resin in 100 ml of 2% methylcellulose and 100 ml of water as a daily retention enema.
+
+Pediatrics-
+
+- Oral: Children should be given 1 g/kg body weight of Calcium Polystyrene Sulfonate daily in divided doses in acute hyperkalemia. In maintenance therapy the dose may be reduced to 0.5 g/kg body weight daily in divided doses.
+- Rectal: It can be given rectally suspended in a proportional amount of 10% dextrose in water. Following retention of the enema, the colon should be irrigated to ensure adequate removal of the resin.
+
+Neonates-
+
+- Oral administration of Calcium Polystyrene Sulfonate is contraindicated in neonates.
+- Only rectal administration should be considered. With rectal administration, the minimum effective dosage within the range of 0.5 g/kg to 1 g/kg should be given diluted as for adults and with adequate irrigation to ensure recovery of the resin.
+
",,"Concomitant use of Calcium Polystyrene Sulfonate is not recommended with Sorbitol, Digitalis drugs, Cation donating agents, Non-absorbable cation-donating antacids and laxatives, Aluminum hydroxide, Lithium, Thyroxine.
","Calcium Polystyrene Sulfonate should not be administered to patients with Serum potassium <5 mmol/L and a conditions associated with hypercalcemia, hyperparathyroidism, multiple myeloma, sarcoidosis or metastic carcinoma, history of hypersensitivity to polystyrene sulfonate resins and obstructive bowel disease. Oral administration of Calcium Polystyrene Sulfonate is contraindicated in neonates.
","Nausea, vomiting, gastric irritation, anorexia, constipation and occasionally diarrhea, fecal impaction, Gastrointestinal stenosis and intestinal obstruction, Gastrointestinal ischemia, ischemic colitis, rectal haemorrhage, gastrointestinal tract ulceration or necrosis, Hypomagnesemia, Hypercalcemia etc. Some cases of acute bronchitis and bronchopneumonia have been reported.
","Calcium Polystyrene Sulfonate is not absorbed from the gastrointestinal tract. No data are available about the use of this in human pregnancy and lactation.
","During treatment with Calcium Polystyrene Sulfonate the possibility of severe potassium depletion should be considered. To prevent serious hypokalemia, administration of the resin should be discontinued as soon as the serum potassium level falls to 5 mmol/L. Hypomagnesemia and hypercalcemia may occur.
Patients should be monitored for all electrolyte disturbances. In the event of clinically significant constipation, treatment with the resin should be discontinued until normal bowel motions are resumed. Magnesium-containing laxatives should not be used. The patient should be positioned carefully when ingesting the resin to avoid aspiration which may lead to bronchopulmonary complications.
",,"Clinical signs and symptoms of hypokalemia including irritability, confusion, delayed thought processes, muscle weakness, hyporeflexia and eventually frank paralysis. Apnea may be a serious consequence of this progression. Electrocardiographic changes may be consistent with hypokalemia or hypercalcemia; cardiac arrhythmia may occur.
",,,"Store at below 30°C in a dry place protected from light. Keep out of reach of children.
",11
+187,Calcium Pantothenate,calcium-pantothenate-187,,Minerals in bone formation,Peripheral neuritis,"Calcium Pantothenate is used as a calcium supplement, dietary supplements, burning feet syndrome, greying hair, peripheral neuritis, muscular cramps.
","Minerals in bone formation, Specific mineral preparations
","Calcium is used to prevent or treat negative calcium balance. It also helps facilitate nerve and muscle performance as well as normal cardiac function. Bone mineral component; cofoactor in enzymatic reactions, essential for neurotransmission, muscle contraction, and many signal transduction pathways.
","Slow intravenous or deep intramuscular as required or as directed by physician.
",,"There are no known drug interactions and none well documented.
","Contraindicated in patients with hypercalcaemia, hypercalciuria.
","Mild gastrointestinal disturbances, bradicardia, arrythmia and irritation after IV injection
","Pregnancy Category-C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","Renal impairment, sarcoidosis, concurrent administration of thiazide diuretics may increase the risk of hypercalcaemia.
",,,,,,9
+55,Amino Acid + D-Sorbitol + Electrolytes,amino-acid-d-sorbitol-electrolytes-55,https://medex.com.bd/attachments/2pInMHTEZSMA6hZJI4GwMoicmoJVk9/amino-acid-d-sorbitol-electrolytes-prescribing-information,Parenteral nutritional preparations,Protein supply for peritoneal nutrition,"Amino acid is indicated as a source of amino acids for protein synthesis in patients needing intravenous nutrition. Amino acid is particularly suitable for patients with basal amino acid requirements. Amino acid is also indicated in faster recovery in surgery, burns, renal insufficiency, hepatic insufficiency and effective management of cancer.
","Parenteral nutritional preparations
","This IV solution is a sterile aqueous solution of crystalline Amino Acid and D-Sorbitol with electrolytes, which are necessary as the nitrogen source for parenteral nutrition. Nitrogen provided in the form of essential and non-essential amino acids. This IV solution contains all 18 essential and non-essential amino acids needed for protein synthesis. The amino acid composition is such that positive nitrogen balance can be achieved in the postoperative period and during extended periods of intravenous nutrition. The solution is clear, colorless to pale yellow colored, having a p H lying in the range of 5.0 to 7.0.
","The nitrogen requirement for maintenance of body protein mass depends on the patient's condition (nutritional state and degree of metabolic stress).
+
+- No or minor metabolic stress and normal nutritional state: 0.10-0.15 g nitrogen/kg/day,
+- Moderate metabolic stress with or without malnutrition: 0.15-0.20 g nitrogen/kg/day,
+- Severe catabolism as in burns, sepsis and trauma: up to 0.20-0.25 g nitrogen/kg/day.
+
+The dosage range 0.10-0.25 g nitrogen/kg/day corresponds to 15-35 ml Amino acids IV/kg/day.
In obese patients, the dose should be based on the estimated ideal weight. Depending upon patients requirements, 1000-2000 ml Amino acids IV may be infused intravenously per 24 hours. Amino acids IV should be infused slowly, at rates 1.4-2.8 ml (30-60 drops) per minute.
In children and infants: The rate of infusion is 28-35 ml/kg body weight per day is recommended, with a step-wise increase in the rate of administration during the frst week.
",,"At the recommended dosage the amino acid have no pharmacological effects and is not expected to interact with other medicaments.
","This is contraindicated in patients with inborn errors of amino acids metabolism, severe liver dysfunction and in severe uremia when dialysis facilities are not available. Due to the content of glucose, Amino Acids IV infusion and 10% Glucose with Electrolytes is contraindicated in patients with hyperosmolar nonketotic diabetic coma.
","This preparation is usually well tolerated. Nausea occurs rarely. Vomiting, flushing and sweating have been observed during infusion of Amino acid at rates exceeding the recommended maximal rate. Transient increases liver test during intravenous nutrition have been reported. The reasons are at present unclear. Hypersensitivity reactions have been reported. As with all hypertonic infusion solutions, thrombophlebitis may occur when peripheral veins are used. The incidence may be reduced by the simultaneous infusion of 10% fat emulsion. If given to severely ill, premature infants, hyperphenylalaninemia may occur.
","Successful and safe administration of amino acid solutions during pregnancy in the human has been reported. Animal reproduction studies have not been carried out with Amino acid.
","IV infusion of amino acids is accompanied by increased urinary excretion of the trace elements copper and in particular zinc, which should be taken into account in the dosing of trace elements, particularly during long-term IV nutrition. Hyperphenylalaninemia may occur in severely ill, premature infants. In these patients, monitoring of the phenylalanine level is recommended and the infusion rate adjusted as needed. Amino Acids IV infusion and 10% Glucose with Electrolytes should be used with caution in patients with diabetes mellitus, severe heart failure or with renal function in combination with fluid restrictions or oliguria/anuria of another origin. In patients with hyperglycemia, administration of exogenous insulin might be necessary. In severely malnourished patients refeeding carbohydrates can trigger thiamine (vitamin B1 ) deficiency syndrome. Those at high risk are patients with a history of alcohol abuse, anorexia nervosa, prolonged fasting or starvation and pregnant women with hyperemesis gravidarum. In this kind of patients, parenteral nutrition containing glucose should be given with caution and parenteral administration of thiamine should be considered before and during the administration of glucose. Monitoring of serum potassium and blood glucose is recommended if Amino Acids IV infusion and 10% Glucose with electrolytes is infused rapidly or in a large quantity. For patients with hypophosphatemia, an additional supply of phosphate is recommended.
",,"If Amino Acids IV infusion and 10% Glucose with Electrolytes is administered at a higher rate than recommended, there is an augmented risk for nausea, vomiting and sweating. When peripheral veins are used thrombophlebitis may occur. Osmotic diuresis with dehydration may occur if the dosage recommendations are exceeded. There is also a risk of symptoms related to hyperglycemia with Amino Acids IV infusion and 10% Glucose with Electrolytes. In case of symptoms due to overdose, the infusion should be slowed down or discontinued.
",,,"Protect from light and store between 15°C to 25°C temperature. Avoid freezing. Keep out of reach of children.
",11
+1708,Dinar,dinar-1708,,Herbal and Nutraceuticals,Jaundice,"This is indicated in-
+
+- Jaundice
+- Hepatitis
+- Ascites
+- Pleurisy
+- Alveolitis
+- Constipation
+- Uterine inflammation
+
","Herbal and Nutraceuticals
","Dinar is an effective herbal preparation containing Chicory (Cichorium endivia), Borage (Borago officinialis), Dodder (Cuscuta reflexa) and other natural ingredients. It helps to promotes bile flow, clears the obstructions of liver, gallbladder and billiary passage. Dinar is very effective in jaundice, hepatitis, constipation, metritis, ascites and pleurisy. It acts prebiotic, stimulates the growth and activities of probiotic (beneficial bacteria), which play the vital role as a safe gourd of health.
","Adults: 2-3 teaspoonfuls twice daily.
Children: 1/2-1 teaspoonful twice daily or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place protect from light.
",8
+1718,Devil’s Cotton + Ashoka bark + Aswagandha,devils-cotton-ashoka-bark-aswagandha-1718,,Herbal and Nutraceuticals,Vaginal leucorrhoea,"This is indicated in-
+
+- Menstrual irregularity
+- Dysmenorrhoea
+- Amenorrhoea
+- Leucorrhoea
+- Metritis
+- Anaemia
+
","Herbal and Nutraceuticals
","This is a uterotonic, specific for female disorders, prepared with valuable natural ingredients like Devil’s Cotton (Abroma augusta), Ashoka Tree (Saraca indica) bark, Aswagandha (Withania somnifera) etc. which acts solely on female reproductive system. This is a general nevine tonic for women. It tones up the nerves, regulates menstrual cycle and cures inflammatory pelvic disorders. It is scientifically prepared herbal syrup which regulates the development of female sexual characteristics and established healthy menstrual functions.
","Menstrual irregularity and dysmenorrhoea: After menstruation till the start of next period, 2 teaspoonfuls to be taken at night
Amenorrhoea: 2 teaspoonfuls to be taken at night
Leucorrhoea: 2 teaspoonfuls to be taken at night
Metritis: 2 teaspoonfuls mixed with lukewarm water to be taken at night
Anaemia: 2 teaspoonfuls to be taken at night. In chronic cases one dose of 2 teaspoonfuls to be taken in the morning as well or as prescribed by the physician.
",,,"It is contraindicated for children.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place protect from light.
",8
+1786,Devil's Claw,devils-claw-1786,https://medex.com.bd/attachments/AJ6EoqIkvkz4XyC94LJIfcIeELADRi/devils-claw-prescribing-information,Herbal and Nutraceuticals,Osteoarthritis (degenerative arthritis),"Back pain: Taking devil's claw by mouth seems to reduce low-back pain. Devil's claw seems to work about as well as some non-steroidal anti-inflammatory drugs (NSAIDs).
Osteoarthritis: Taking devil's claw alone or along with nonsteroidal anti-inflammatory ... Read more
Back pain: Taking devil's claw by mouth seems to reduce low-back pain. Devil's claw seems to work about as well as some non-steroidal anti-inflammatory drugs (NSAIDs).
Osteoarthritis: Taking devil's claw alone or along with nonsteroidal anti-inflammatory drugs (NSAIDs) seems to help decrease osteoarthritis-related pain. Some evidence suggests that devil's claw works about as well as diacerhein (a slow-acting drug for osteoarthritis that is not available in the U.S.) for improving osteoarthritis pain in the hip and knee after 16 weeks of treatment. Some people taking devil's claw seem to be able to lower the dose of NSAIDs they need for pain relief. This evidence comes from a study that used a specific powdered devil's claw root product (Harpadol, Arkopharma) containing 2% of the devil's claw ingredient harpagoside (9.5 mg/capsule) and 3% total iridoid glycosides (14.5 mg per capsule). Another specific devil's claw extract (Doloteffin, Ardeypharm) 2400 mg/day providing 60 mg/day of the harpagoside ingredient has also been used.
","Herbal and Nutraceuticals
","Devil's claw contains chemicals that might decrease inflammation and swelling and resulting pain.
","For osteoarthritis: A specific powdered devil's claw root product (Harpadol, Arkopharm) dosed at 2.6 grams/day. This dose provides a total of 57 mg of harpagoside, one of the active ingredients, and 87 mg of total iridoid glycosides, another active ingredient. Another specific devil's claw extract (Doloteffin, Ardeypharm) dosed at 2400 mg/day has also been used.
For back pain: A specific devil's claw extract (Doloteffin, Ardeypharm) that provides 50-100 mg of the active ingredient harpagoside daily.
",,,,"Devil's claw is possibly safe for most adults when taken by mouth in appropriate doses for up to a year. The most common side effect is diarrhea. About 8% of the people participating in one research study developed diarrhea. Other possible side effects include nausea, vomiting, abdominal pain, headaches, ringing in the ears, loss of appetite, and loss of taste. It can also cause allergic skin reactions, menstrual problems, and changes in blood pressure. However, not enough is known about the safety of using devil's claw long-term or applying it to the skin.
","Devil's claw is possibly safe. It might harm the developing fetus. Avoid use in pregnancy. It is also best to avoid using devil's claw while breast-feeding. Not enough is known yet about its safety during breast-feeding.
","Heart problems, high blood pressure, low blood pressure: Since devil's claw can affect heart rate, heartbeat, and blood pressure, it might harm people with disorders of the heart and circulatory system. If you have one of these conditions, talk with your healthcare provider before starting devil's claw.
Diabetes: Devil's claw might lower blood sugar levels. Using it along with medications that lower blood sugar might cause blood sugar to drop too low. Monitor blood glucose levels closely. Your healthcare provider might need to adjust your dose of diabetes medications.
Gallstones: Devil's claw might increase bile production. This could be a problem for people with gallstones. Avoid using devil's claw.
Peptic ulcer disease (PUD): Since devil's claw might increase the production of stomach acids, it might harm people with stomach ulcers. Avoid using devil's claw.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",8
+1701,Datura + Rhubarb + Ginger,datura-rhubarb-ginger-1701,,Herbal and Nutraceuticals,Pain,"This tablet is indicated in-
+
+- Pyrexia
+- Dyspnoea
+- Pain
+- Exhaustion
+- Convulsion due to excessive bile
+
","Herbal and Nutraceuticals
","This is a very effective preparation of Datura (Datura stramonium), Ginger (Zingiber officinale) and other ingredients. It is very effective in pyrexia and dyspnoea. This also acts as an analgesic.
","1-2 tablet(s) twice daily or as prescribed by the physicians.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Protect from light. Keep in cool & dry place.
",8
+1733,Date palm + Betel nut + Acacia,date-palm-betel-nut-acacia-1733,,Herbal and Nutraceuticals,Vaginal leucorrhoea,"This is indicated in-
+
+- Weakness of uterus
+- Leucorrhoea
+- Infertility
+- Spermatorrhoea
+- Premature ejaculation
+
","Herbal and Nutraceuticals
","This is an amazing combination of time tested effective medicinal plants, acts as a wonderful uterotonic, helps in increasing the retentive power of the uterus and removes debility after childbirth. It used for 1-11/2 month(s) by the both partners helps in effective conception in woman. It is also helpful for males in spermatorrhoea, oligospermia, nocturnal emissions, and premature ejaculation and helps to remove leucorrhoea in females.
","2-3 teaspoonfuls 1-2 times daily or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Protect from light. Keep in cool & dry place. Shake well before use.
",8
+2054,Alpha Lipoic Acid,alpha-lipoic-acid-2054,,,,"This tablet has potent antioxidant and neurotrophic properties. This helps you cope with the pain caused by:
+
+- Peripheral and diabetic neuropathies
+- Sciatica, backache, cervical syndrome, carpal tunnel syndrome
+- Migraine headaches
+
",,"α-Lipoic Acid is a substance which can be naturally found in animal and plant tissues and maintains its activity both in aqueous cell compartments and in those lipid membrane ones. Chromium Picolinate is a biologically active organic Chromium. Selenium and Zinc are essential minerals. It contains Vitamins of the B group, including the Vitamin B1 (Thiamine), also known as Antineuritic Vitamin.
Medical Pharmaquality is a dietary supplement containing an antioxidant combination with 600 mg alpha lipoic acid, trace elements (selenium, zinc and picolino chromium) and vitamins (B1, B5, B6, biotin and vitamin E) that have strong anti-inflammatory effects and neurotrophic properties. Alpha lipoic acid, zinc, selenium, picoline chromium and vitamin E help protect cells from oxidative stress. peripheral nerves (neuritis), protects the nervous system from degenerative phenomena. Picolinate chromium, zinc and biotin can help regulate glucose levels. Medical Pharmaquality can contribute to the relief of discomfort due to peripheral and diabetic neuropathies, sciatica, back pain, cervical syndrome, carpal tunnel syndrome, migraines. The retard form of this (prolonged-release) tablet ensures effectiveness with just one tablet per day.
","It is recommended to take 1 tablet daily, preferably on an empty stomach.
",,,"Contraindicated in people receiving treatment for diabetes.
",,,"The Food Supplements should not be understood as a substitute for a varied and balanced diet and a healthy lifestyle. Do not exceed the recommended daily dose. Keep out of reach of children under 3 years of age. Do not take in case of hypersensitivity or allergy to one or more components. Before the possible use of the product, if you should be in treatment with hypoglycaemic pharmaceuticals, please consult with your own physician.
",,,,,,5
+1871,Alogliptin Benzoate,alogliptin-benzoate-1871,https://medex.com.bd/attachments/GgEMxt1gx1UdvwZV4f5cOrfs1gfMAO/alogliptin-benzoate-prescribing-information,Dipeptidyl Peptidase-4 (DPP-4) inhibitor,Type 2 DM,"Alogliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes mellitus.
","Dipeptidyl Peptidase-4 (DPP-4) inhibitor
","Alogliptin is a DPP-4 inhibitor that slows the inactivation of the incretin hormones, thereby increasing their bloodstream concentrations and reducing fasting and postprandial glucose concentrations in a glucose-dependent manner in patients with type 2 diabetes mellitus. Increased concentrations of the incretin hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are released into the bloodstream from the small intestine in response to meals. These hormones cause insulin release from the pancreatic beta cells in a glucose-dependent manner but are inactivated by the DPP-4 enzyme within minutes. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, reducing hepatic glucose production. In patients with type 2 diabetes, concentrations of GLP-1 are reduced but the insulin response to GLP-1 is preserved.
","The recommended dose in patients with normal renal function or mild renal impairment is 25 mg once daily or as directed by the physicians.
",,"Alogliptin is primarily renally excreted. Cytochrome (CYP) P450-related metabolism is negligible. No significant drug-drug interactions are observed with the CYP-substrates or inhibitors tested or with renally excreted drugs.
","History of a serious hypersensitivity reaction to Alogliptin-containing products, such as anaphylaxis, angioedema or severe cutaneous adverse reactions.
","Common side effects are nasopharyngitis, headache and upper respiratory tract infection.
","Pregnancy Category B. No adequate or well-controlled studies in pregnant women have been conducted with Alogliptin. Alogliptin tablets should be used during pregnancy only if clearly needed. It is not known whether Alogliptintin is excreted in human milk. caution should be exercised when Alogliptin is administered to a nursing woman.
","Acute pancreatitis: If pancreatitis is suspected, promptly Alogliptin should be discontinued.
Hypersensitivity: There have been postmarketing reports of serious hypersensitivity reactions in patients treated with Alogliptin such as anaphylaxis, angioedema and severe cutaneous adverse reactions. In such cases, promptly Alogliptin should be discontinued.
Hepatic effects: Postmarketing reports of hepatic failure, sometimes fatal. Causality can not be excluded. If liver injury is detected, promptly interrupt Alogliptin and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart Alogliptin if liver injury is confirmed and no alternative etiology can be found.
Hypoglycemia: When an insulin secretagogue (e.g. sulfonylurea) or insulin is used in combination with Alogliptin, a lower dose of the insulin secretagogue or insulin may be required to minimize the risk of hypoglycaemia.
Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Alogliptin or any other antidiabetic drug.
","Pediatric Use: Safety and effectiveness of Alogliptin in pediatric patients have not been established.
Geriatric Use: Of the total number of patients (N=8507) in clinical safety and efficacy studies treated with Alogliptin, 2064 (24.3%) patients were 65 years and older and 341 (4%) patients were 75 years and older. No overall differences in safety or effectiveness were observed between patients 65 years and over and younger patients. While this clinical experience has not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.
Hepatic Impairment: No dose adjustments are required in patients with mild to moderate hepatic impairment (Child-Pugh Grade A and B) based on insignificant change in systemic exposures (e.g., AUC) compared to subjects with normal hepatic function in a pharmacokinetic study. Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh Grade C). Use caution when administering Alogliptin to patients with liver disease.
Patients with Renal Impairment:
+
+- No dose adjustment of Alogliptin is necessary for patients with mild renal impairment (creatinine clearance ≥60 mL/min).
+- The dose of Alogliptin is 12.5 mg once daily for patients with moderate renal impairment (creatinine clearance ≥30 to <60 mL/min).
+- The dose of Alogliptin is 6.25 mg once daily for patients with severe renal impairment (creatinine clearance ≥15 to <30 mL/min) or with end-stage renal disease (ESRD) (creatinine clearance <15 mL/min or requiring hemodialysis).
+- Patients requiring hemodialysis can receive their dose of alogliptin without regard to the timing of the dialysis.
+
","The highest doses of Alogliptin administered in clinical trials were single doses of 800 mg to healthy subjects and doses of 400 mg once daily for 14 days to patients with type 2 diabetes (equivalent to 32 times and 16 times the maximum recommended clinical dose of 25 mg, respectively). No serious adverse events were observed at these doses. In the event of an overdose, it is reasonable to institute the necessary clinical monitoring and supportive therapy as dictated by the patient's clinical status. Per clinical judgment, it may be reasonable to initiate removal of unabsorbed material from the gastrointestinal tract. Alogliptin is minimally dialyzable; over a 3-hour hemodialysis session, approximately 7% of the drug was removed. Therefore, hemodialysis is unlikely to be beneficial in an overdose situation. It is not known if Alogliptin is dialyzable by peritoneal dialysis.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+44,Almotriptan,almotriptan-44,https://medex.com.bd/attachments/pmuXvtLp0xtOYvS3OIQtSV6ijaT97G/almotriptan-prescribing-information,5-HT Agonists,Migraine headache,"Almotriptan is prescribed to treat the acute headache phase of migraine attacks with or without aura. Almotriptan is the only oral triptan approved in the USA for the treatment of migraine in adolescent from 12 to 17 years of age.
","5-HT Agonists
","Almotriptan is a selective and potent serotonin (5-hydroxytryptamine 1B/1D) agonist. Almotriptan binds to specific serotonin receptors on meningeal arteries inhibiting the release of vasoactive peptides and causing constriction of the arteries. It has a limited effect on arteries supplying blood to the brain and little effect on cardiac and pulmonary vessels.
","Acute Treatment of Migraine Attacks: The recommended dose of Almotriptan in adults and adolescents age 12 to 17 years is 6.25 mg to 12.5 mg, with the 12.5 mg dose tending to be a more effective dose in adults. If the headache is relieved after the initial almotriptan malate dose but returns, the dose may be repeated after 2 hours. The maximum daily dose should not exceed 25 mg. The safety of treating an average of more than four migraines in a 30-day period has not been established.
Hepatic Impairment: The recommended starting dose of almotriptan malate in patients with hepatic impairment is 6.25 mg. The maximum daily dose should not exceed 12.5 mg over a 24-hour period
Renal Impairment: The recommended starting dose of almotriptan malate in patients with severe renal impairment is 6.25 mg. The maximum daily dose should not exceed 12.5 mg over a 24-hour period
",,"These drugs have been reported to cause prolonged vasospastic reactions. Cases of life-threatening serotonin syndrome have been reported during combined use of triptans and selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs).
","As with other 5-HT1B/1D receptor agonists, almotriptan should not be used in patients with a history, symptoms or signs of ischaemic heart disease (myocardial infarction, angina pectoris, documented silent ischaemia, Prinzmetal's angina) or severe hypertension and uncontrolled mild or moderate hypertension. Concomitant administration with ergotamine, ergotamine derivatives (including methysergide) and other 5-HT1B/1D agonists is contraindicated.
","Serious cardiac reactions, including myocardial infarction, have occurred following the use of almotriptan malate Tablets. These reactions are extremely rare and most have been reported in patients with risk factors predictive of CAD (Coronary Artery Disease).
","Pregnancy Category C. There is no data regarding excretion of almotriptan in human milk.
","Hypersensitivity to the active substance or to any of the excipients. Patients with severe hepatic impairment, with a previous cerebrovascular accident (CVA) or transient ischaemic attack (TIA) Peripheral vascular disease.
",,,,,"Keep below 30° C temperature in a dry place. Protected from light. Do not freeze. Keep out of the reach of children.
",10
+39,Almitrine Bismesylate + Raubasine,almitrine-bismesylate-raubasine-39,,Cerebral vasodilator & Neurosensory oxygenator drugs,Vestibular and visual disorders of ischaemic aetiology,"This tablet is indicated for-
+
+- Reduction of neurological damage & accelerates recovery after cerebral stroke
+- Minor age-related neurological disorders
+- Some visual disorders related to the circulation
+- Some disorders of the inner ear related to circulation (hearing loss, dizziness, buzzing sounds in the ear).
+
","Cerebral vasodilator & Neurosensory oxygenator drugs
","Almitrine Bismesylate & Raubasine combines raubasine, a vasodilator; and almitrine, a respiratory stimulant. Raubasine has a adrenolytic activity which is predominantly related to a post-synaptic blocking effect. Furthermore, under conditions of cerebral hypoxia, almitrine causes an increase in the partial pressure of oxygen in arterial blood (Pa02); almitrine causes an increase in the Pa02 and an increase in the oxygen saturation in arterial blood (Sa02), without modifying ventilatory parameters.
","1 tablet once or twice daily (taken separately, several hours apart), without exceeding 2 tablets per day. Or, as directed by the registered physicians.
",,"Do not associate with MAO-l (monoamine oxidase inhibitor), Not to be used concurrently with other almitrine-containing preparations.
","This tablet is contraindicated in patients with hypersensitivity to any of the ingredients of it or severe hepatic impairment.
","Weight loss, nausea, sensations of heaviness or burning in the stomach, gastrointestinal disorders, diarrhoea or constipation, insomnia, drowsiness, agitation, anxiety, dizziness, palpitations.
","It is not recommended in pregnancy. It should be used with caution only when the expected benefit to the mother is greater than the possible risk to the fetus.
","Due to the presence of lactose, this drug should not be used in the case of galactosemia, of glucose and galactose malabsorption syndrome or of lactose deficiency (rare metabolic diseases). Do not exceed the recommended dose.
",,"Signs include tachycardia, arterial hypotension, polypnoea and respiratory alkalosis.
",,,"Store at a cool and dry place, protected from light and moisture. Keep out of reach of children.
",11
+1369,Allylestrenol,allylestrenol-1369,,Female Sex hormones,Threatened abortion,"Allylestrenol is indicated in:
+
+- Intra Uterine Growth Retardation (IUGR)
+- Threatened abortion
+- Habitual abortion
+- Threatened premature delivery
+
","Female Sex hormones
","Allylestrenol has been found to have a relatively weak progestational effect on the human endometrium. To obtain a full secretory endometrium in oestrogen-primed castrated women or to postpone menstruation (with an oestrogen added) in normal ovulating women, doses of allylestrenol were required which were higher than those recommended for the treatment/prevention of abortion.
In vitro studies have shown that allylestrenol stimulates the synthesis of progesterone in the human placenta. It also brought about a significant (p/. 0,01) increase in the production of some specific placental enzymes (cystine aminopeptidase and heat-stable alkaline phosphatase).
Histological and histochemical changes indicating an increased activity have been found in the placenta, particularly in the syncytiotrophoblast of women with a normal and threatened pregnancy, treated with allylestrenol. The stimulatory effect of allylestrenol on placental function was also suggested by the increased level of placental hormones (pregnanediol, oestriol, HCG and HPL) and enzymes (oxytocinase, CAP) in the maternal urine and plasma, which followed the administration of the drug e.g. in the early weeks as well as in the last trimester of pregnancy.
A study in full-term pregnant women revealed that allylestrenol in high doses (up to 100 mg daily) did suppress the intensity of spontaneous uterine contractions, but had no effect on the sensitivity of the uterine muscle to oxytocin, and no adverse effect on the progress of normal delivery.
Studies in non-pregnant women with and without endocrinological disorders have shown that allylestrenol has no oestrogenic or androgenic properties and no adverse effects on the adrenal function.
No abnormal liver function tests or water and salt retention were observed in healthy female volunteers (non pregnant) who were given allylestrenol.
","Intra Uterine Growth Retardation: 1 tablet three times a day at least two months. Dose to be reduced if symptoms improve.
Threatened abortion: 1 tablet three times daily until symptoms disappear.
Habitual abortion: 1-2 tablets daily as soon as pregnancy is diagnosed. The administration should be continued for at least one month after the end of the critical period.
Threatened premature delivery: Dosage must be determined individually. High dosages (up to 40 mg daily) have been used.
In case of a missed dose, it should be taken as soon as the patient remembers & she should continue the regular dosing schedule. A double dose is not recommended.
",,,"
+- Breast Cancer or history of problem with the breasts like- Nodules,an abnormal Mammogram, or Fibrocystic Diseases.
+- Severe liver disease such as Cholestatic Jaundice or Hepatitis, Hepatic Cell Tumours, Rotor Syndrome and Dubin Jhonson Syndrome.
+- Undiagnosed vaginal bleeding
+- Toxaemia of Pregnancy
+- Crisis Seizures, Migraines
+
","Treatment with Allylestrenol (especially a long term treatment) is known to cause some gastrointestinal complaints such as vomiting, nausea, and sometimes epigastric discomfort.
","Allylestrenol is specifically designed to be taken during pregnancy. It should be discontinued after delivery as it may affect a nursing infant to a small but noticeable degree.
","Patients with the following conditions should be cautious: Heart disease, congestive heart failure, sick sinus syndrome, coronary artery disease, seizures, epilepsy, renal dysfunction, migraine headaches, or breathing diseases including asthma, emphysema, chronic bronchitis, or COPD, breast-feeding.
","It should not be used for children younger than 16 years old.
","Symptoms of overdose may include unusual drowsiness; rapid pulse; fainting; unusual muscle movement or rigidity of the face, neck, or limbs; seizures; and loss of consciousness.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+1850,Cefprozil,cefprozil-1850,https://medex.com.bd/attachments/xTIveQwrtZkmHa8yp04iRnAIv7u6TW/cefprozil-prescribing-information,Second generation Cephalosporins,Upper and lower respiratory tract infections,"Cefprozil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains. Infections include:
+
+- Lower respiratory tract infections: acute bronchitis, acute exacerbations of chronic bronchitis, community acquired pneumonia.
+- Upper respiratory tract and ear infections: otitis media, sinusitis, tonsillitis and pharyngitis.
+- Uncomplicated skin and soft tissue infections.
+
","Second generation Cephalosporins
","Cefprozil is a preparation of Cefprozil, which is a semi synthetic, second-generation cephalosporin antibiotic indicated for the treatment of patients with mild to moderate infections caused by susceptible strains.
+
+- Ensures treatment success in pediatric GAS pharyngitis/tonsillitis
+- A drug of choice for pediatric patients with tonsilopharyngitis
+- Guarantees treatment success in SSTI
+
+Cefprozil is a semi synthetic, second-generation cephalosporin antibiotic. Cefprozil is active in vitro against both gram positive and gram negative bacteria. The bactericidal activity of cefprozil results from the inhibition of cell wall synthesis via affinity for penicillin-binding proteins (PBPs).
","Adults (13 years and older)-Upper Respiratory Tract:
+
+- Pharyngitis/Tonsillitis: 500 q24h for 10 days
+- Acute Sinusitis (For moderate to severe infections, the higher dose should be used): 250 q12h or 500 q12h for 10 days
+
+Lower Respiratory Tract:
+
+- Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis: 500 q12h for 10 days.
+
+Skin And Skin Structure:
+
+- Uncomplicated Skin and Skin Structure Infections 250 q12h or 500 q24h or 500 q12h for 10 days.
+
+
Children (2 years–12 years)-Upper Respiratory Tract:
+
+- Pharyngitis/Tonsillitis: 7.5 mg/kg q12h for 10 days
+
+Skin And Skin Structure:
+
+- Uncomplicated Skin and Skin Structure Infections 20 mg/kg q24h for 10 days.
+
+
Infants & Children (6 months–12 years)-Upper Respiratory Tract:
+
+- Otitis Media: 15 mg/kg q12h for 10 days
+- Acute Sinusitis (For moderate to severe infections, the higher dose should be used): 7.5 mg/kg q12h or 15 mg/kg q12h for 10 days.
+
",,"Nephrotoxicity has been reported following concomitant administration of aminoglycoside antibiotics and cephalosporin antibiotics. Concomitant administration of probenecid doubled the AUC for cefprozil.
","Hypersensitivity to cephalosporin antibiotics.
","The adverse reactions to cefprozil are similar to those observed with other orally administered cephalosporins. Cefprozil was usually well tolerated in controlled clinical trials. The most common adverse effects of cefprozil are diarrhea, nausea, vomiting, abdominal pain, rash, urticaria, dizziness, hyperactivity, insomnia, confusion etc.
","Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Small amounts of cefprozil (<0.3% of dose) have been detected in human milk following administration of a single 1 gram dose to lactating women. Caution should be exercised when cefprozil is administered to a nursing woman, since the effect of cefprozil on nursing infants is unknown.
","In patients with known or suspected renal impairment, careful clinical observation and appropriate laboratory studies should be done prior to and during therapy. Prolonged use of cefprozil may result in the overgrowth of nonsusceptible organisms. Cefprozil should be prescribed with caution in individuals with a history of gastrointestinal disease particularly colitis.
",,,,,"Cefprozil powder for suspension should be stored in a cool, dry place (preferably below 30°C) and should be protected from light. Keep out of reach of children.
",10
+221,Cefpodoxime Proxetil + Clavulanic Acid,cefpodoxime-proxetil-clavulanic-acid-221,,Third generation Cephalosporins,Urinary tract infection,"It is indicated in the following infections -
+
+- Acute bacterial exacerbation of chronic bronchitis
+- Acute community acquired pneumonia
+- Pharyngitis or tonsillitis
+- Skin and soft tissue infections
+- Urinary tract infections
+- Uncomplicated gonorrhea
+- Acute maxillary sinusitis
+
","Third generation Cephalosporins
","Cefpodoxime is a third generation semi-synthetic Cephalosporin, exhibits activity against several Gram positive as well as Gram negative microorganisms. This compound is also stable in beta lactamase environment. Cefpodoxime exhibits exceptional activity against methicillin susceptible Staphylococci, Streptococcus pneumoniae, Haemophilus influenzae, Neisseria spp. and Moraxella catarrhalis.
Clavulanic acid is a natural inhibitor of beta lactamase which are produced by Streptomyces clavuligerus. It binds to beta lactamase moieties and inactivates them, thus restricting the Cefpodoxime destruction.
","For adults (Age 12 years and older):
+
+- Acute bacterial exacerbation of chronic bronchitis: 1 tablet 12 hourly for 10 days
+- Acute community acquired pneumonia: 1 tablet 12 hourly for 14 days
+- Pharyngitis or tonsillitis: ½ tablet 12 hourly for 5 to 10 days
+- Skin and soft tissue infections: 2 tablet 12 hourly for 7 to 14 days
+- Urinary tract infections: ½ tablet 12 hourly for 7 days
+- Uncomplicated gonorrhea: Single dose
+- Acute maxillary sinusitis: 1 tablet 12 hourly for 10 days
+
+For children: Children 2 months to 12 years- 10 mg/kg/day in divided dose, every 12 hours.
",,"Concomitant administration of Cefpodoxime at high doses with antacids or H2 blockers reduces peak plasma levels of Cefpodoxime.
","Cefpodoxime is contraindicated in patients with known hypersensitivity to Cephalosporins.
","Cefpodoxime is well tolerated. Most common gastrointestinal adverse effects are diarrhea, vomiting and abdominal pain.
","US FDA pregnancy category of Cefpodoxime & Clavulanic Acid is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.
","Cefpodoxime should be administered with caution to patients receiving concurrent treatment with diuretics.
",,,,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",10
+220,Cefpodoxime Proxetil,cefpodoxime-proxetil-220,https://medex.com.bd/attachments/dbN1xxhB9gnSs6dvZOpQmMQGkOBqui/cefpodoxime-proxetil-prescribing-information,Third generation Cephalosporins,Urinary tract infection,"Cefpodoxime is indicated for the treatment of infections caused by susceptible microorganism, listed below:
+
+- Acute otitis media caused by Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenza, Moraxella catarrhalis (including beta-lactamase producing strains).
+- Pharyngitis/tonsillitis caused by Streptococcus pyogenes.
... Read more
Cefpodoxime is indicated for the treatment of infections caused by susceptible microorganism, listed below:
+
+- Acute otitis media caused by Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenza, Moraxella catarrhalis (including beta-lactamase producing strains).
+- Pharyngitis/tonsillitis caused by Streptococcus pyogenes.
+- Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase producing strains), Streptococcus pneumoniae and Moraxella catarrhalis.
+- Community acquired pneumonia caused by S. pneumoniae or H. influenza (including beta-lactamase-producing strains).
+- Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis.
+- Skin and skin structure infections caused by Staphylococcus aureus, Streptococcus pyogenes.
+- Uncomplicated urinary tract infections caused by E. coli, Klebsiella pneumoniae, Proteus mirabilis or Staphylococcus saprophyticus.
+- Uncomplicated gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains).
+- Rectal gonococcal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains).
+
","Third generation Cephalosporins
","Cefpodoxime is an oral 3rd generation cephalosporin, which has good stability to beta lactamases and activity against Gram negative and Gram positive bacteria. It is indicated for the treatment of infections either before the infecting organism has been identified. It is a prodrug its active metabolite is Cefpodoxime. Approximately 29 to 33% of Cefpodoxime excreted unchanged in the urine in 12 hours.
","Adults and Adolescents (13 years and older)
+
+- Pharyngitis/tonsillitis: 100 mg 12 hourly, 5 to 10 days
+- Acute maxillary sinusitis: 200 mg 12 hourly, 10 day
+- Community acquired pneumonia: 200 mg 12 hourly, 14 days
+- Acute bacterial exacerbations of chronic bronchitis: 200 mg 12 hourly, 10 days
+- Skin and skin structure: 400 mg 12 hourly, 7 to 14 days
+- Uncomplicated urinary tract infection: 100 mg 12 hourly, 7 days
+- Uncomplicated gonorrhea: single dose of 200 mg
+- Rectal gonococcal infections in women: single dose of 200 mg
+
+Infants and Pediatric Patients (2 months to 12 years)
+
+- Acute otitis media: 5 mg/kg body weight 12 hourly, 5 days
+- Pharyngitis /tonsillitis: 5 mg/kg body weight 12 hourly, 5 to 10 days
+- Acute maxillary sinusitis: 5 mg/kg body weight 12 hourly, 10 days
+
",,"Cefpodoxime concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduces peak plasma levels and the extent of absorption respectively. Renal excretion of Cefpodoxime is inhibit by probenecid.
","Cefpodoxime is contraindicated in patients with known allergy to cephalosporins.
","Cefpodoxime has very few side effects. Possible side effects include gastrointestinal disorders (such as- diarrhea, nausea, vomiting and abdominal pain), rash, urticaria and itching.
","US FDA pregnancy category of Cefpodoxime is B. There is, however, no adequate and well-controlled study in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.
","In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of Cefpodoxime should be reduced. Cefpodoxime should be administered with caution to patients receiving concurrent treatment with potent diuretics. As with other antibiotics, prolonged use of Cefpodoxime may result in overgrowth of non-susceptible organisms.
","Patients with severe renal impairment (creatinin clearance <30 ml/min) the dosing intervals should be increased to 24 hourly. The dosage adjustment is not require in cases of hepatic impairment.
",,,"Step 1: Shake the bottle well to loosen the powder.
Step 2: Add boiled and cooled water in the bottle.
Step 3: Shake until powder is completely mixed with water.
","Keep in a dry place away from light and heat. Keep out of the reach of children.
",12
+219,Cefpirome Sulphate,cefpirome-sulphate-219,https://medex.com.bd/attachments/Gd5huVpeMyyK3OI9OigE5S1PLGMJgh/cefpirome-sulphate-prescribing-information,Fourth generation Cephalosporins,Susceptible infections,"Cefpirome is indicated in:
+
+- Severe infections, such as septicemia, bacteremia and infections in immunosuppressed neutropenic patients with hematological malignancies
+- Lower respiratory infections including pneumonia
+- Severe urinary tract infections including pyelonephritis
+- Skin and soft tissue infections
... Read more
Cefpirome is indicated in:
+
+- Severe infections, such as septicemia, bacteremia and infections in immunosuppressed neutropenic patients with hematological malignancies
+- Lower respiratory infections including pneumonia
+- Severe urinary tract infections including pyelonephritis
+- Skin and soft tissue infections
+- Bone and joint infections
+- Infections in immunocompromised patients
+- Other infections
+
","Fourth generation Cephalosporins
","Cefpirome binds to one or more of the penicillin-binding proteins (PBPs) which inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell wall, thus inhibiting biosynthesis and arresting cell wall assembly resulting in bacterial cell death.
","Adult: 1-2 gm every 12 hour via IV injection over 3-5 minutes or infuse over 20-30 minutes.
Elderly: There are no special precautions for its use in the elderly provided dosage is adjusted accordingly to renal function.
Cefpirome is administered only through the parenteral route. The dosage is dependent upon the severity and site of infection, the susceptibility of the infecting microorganisms and age, weight and renal function of the patient. The drug is administered through intravenous injection or infusion. The following dosages are recommended for moderate to severe infections in adult patients with normal renal function:
+
+- Complicated upper & lower urinary tract infections: 1 gm 12 hourly. Total daily dose not more then 2 gm
+- Skin & soft tissue infections: 1 gm 12 hourly. Total daily dose not more then 2 gm
+- Lower respiratory tract infections: 1 to 2 gm 12 hourly. Total daily dose not more then 2 to 4 gm
+- Bacteraemia or septicaemia and severe infections: 2 gm 12 hourly. Total daily dose not more then 4 gm
+- Infections in neutropenic patients: 2 gm 12 hourly. Total daily dose not more then 4 gm
+
+Dose reduction is necessary in patients with markedly reduced renal function. After an initial dose of 0.5 -2 gm to establish a high serum concentration, the dose should be reduced by 50% for clearances of 49-21 ml/min or 75% for clearances of 20 ml/min. In end-stage renal disease, a supplementary dose equal to 50% of the recommended daily dose should be administered after each hemodialysis
treatment.
",,"Drug interactions have not been observed with Cefpirome.
","Cefpirome is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
","Cefpirome is generally well tolerated. There are no predictable life threatening effects of Cefpirome. Adverse gastrointestinal reactions include diarrhea, nausea, vomiting, pseudomembraneous colitis, abdominal pain and have been noted 3.86% of the patients. Superficial phlebitis, thrombophlebitis and infection site reaction have been reported in 2.31% of patients receiving intravenous Cefpirome.
","The safety of Cefpirome has not been established in pregnancy and as with all agents it should be administered with caution, especially during the early months of pregnancy. As Cefpirome is excreted in human breast milk, either Cefpirome treatment should be discontinued or breast feeding ceased.
","Allergy to penicillin or to cephalosporins; renal impairment, monitor renal and haematological status; pregnancy and lactation.
",,"No cases of over dosage are known. However, general supportive care with monitoring of renal, hematological and hepatic function and coagulation status is recommended.
","The duration of treatment depends on the patient’s clinical and bacteriological response.
","It is highly recommended to use the reconstituted solution immediately. During reconstitution the following procedure to be recommended and after reconstitution use within specified time line maintaining storage condition.
Step 1: Add recommended volume of solvent slowly. Remove the syringe needle.
Step 2: Gently shake the vial to dissolve the powder. Carbon dioxide is released & a clear solution will be obtained.
Step 3: Now insert the needle in the free space of the reconstituted vial & withdraw the pressurized air from the free space.
Step 4: Finally withdraw the solution from the vial by syringe.
","Cefpirome vial should be stored below 25° C, protected from light and moisture. Reconstituted solution can be stored for up to 6 hours at room temperature and 24 hours in refrigerator (at 2-8° C) when prepared in water for injection.
",13
+1274,Cefoxitin,cefoxitin-1274,https://medex.com.bd/attachments/qDM07CtFAoAnO40G7eNK8c3I4HlvTM/cefoxitin-prescribing-information,Second generation Cephalosporins,Urinary tract infection,"Cefoxitin is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below.
Lower respiratory tract infections, including pneumonia and lung abscess, caused by Streptococcus ... Read more
Cefoxitin is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below.
Lower respiratory tract infections, including pneumonia and lung abscess, caused by Streptococcus pneumoniae, other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus(including penicillinaseproducing strains), Escherichia coli, Klebsiella species, Haemophilus influenzae, and Bacteroides species.
Urinary tract infections caused by Escherichia coli, Klebsiella species, Proteus mirabilis, Morganella morganii, Proteus vulgarisand Providencia species (including P. rettgeri).
Intra-abdominal infections, including peritonitis and intra-abdominal abscess, caused by Escherichia coli, Klebsiella species, Bacteroides species including Bacteroides fragilis, and Clostridium species.
Gynecological infections, including endometritis, pelvic cellulitis, and pelvic inflammatory disease caused by Escherichia coli, Neisseria gonorrhoeae (including penicillinase-producing strains), Bacteroides species including B. fragilis, Clostridium species, Peptococcus niger, Peptostreptococcus species, and Streptococcus agalactiae. Cefoxitin, like cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when Cefoxitin is used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added.
Septicemia caused by Streptococcus pneumoniae, Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli, Klebsiella species, and Bacteroides species including B. fragilis.
Bone and joint infections caused by Staphylococcus aureus (including Penicillinaseproducing strains).
Skin and skin structure infections caused by Staphylococcus aureus (including penicillinase-producing strains), Staphylococcus epidermidis, Streptococcus pyogenes and other streptococci (excluding enterococci e.g., Enterococcus faecalis), Escherichia coli, Proteus mirabilis, Klebsiella species, Bacteroides species includingB. fragilis, Clostridium species, Peptococcus niger, and Peptostreptococcus species.
","Second generation Cephalosporins
","Cefoxitin inhibits bacterial cell wall synthesis by binding to 1 or more of the penicillin-binding proteins (PBPs) which in turn inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis and arresting cell wall assembly resulting in bacterial cell death.
","Intravenous:
Abdominal infections, Bone and joint infections, Gynaecological infections, Respiratory tract infections, Skin and skin structure infections, Urinary tract infections:
+
+- Adult: 1-2 g 6-8 hrly, up to 12 g daily given in 4-6 divided doses in severe infections. Doses are given by slow inj over 3-5 min or, by intermittent or continuous infusion.
+- Child: ≥3 mth 80-160 mg/kg daily in 4-6 equally divided doses. Max: 12 g daily.
+
+Prophylaxis of surgical infections:
+
+- Adult: 2 g 30-60 min prior to surgery, then 6 hrly for not more than 24 hr. For caesarean section: 2 g as a single dose as soon as the umbilical cord is clamped; a further 2 g dose 4 hr and 8 hr after the initial dose may be given if necessary.
+- Child: ≥3 mth 30-40 mg/kg 30-60 min prior to surgery, then 6 hrly for not more than 24 hr.
+
",,"Reduces renal clearance with probenecid. Concurrent use of nephrotoxic agents (e.g. aminoglycosides, colistin, polymyxin B, vancomycin) may increase the risk of nephrotoxicity.
","Hypersensitivity to cefoxitin and other cephalosporins.
","Hypersensitivity reactions (e.g. maculopapular or erythematous rash, exfoliative dermatitis, pruritus, urticaria, eosinophilia, fever, angioedema); elevated serum creatinine and/or BUN concentrations, anaemia; transient increase in serum AST (SGOT), ALT (SGPT), LDH and alkaline phosphatase levels; jaundice; thrombophlebitis. Rarely, oliguria, renal toxicity, neutropenia, transient leucopenia, granulocytopenia, thrombocytopenia, bone marrow depression; GI effects (e.g. nausea, vomiting, diarrhoea).
","Pregnancy Category B. Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
","Patient with history of penicillin allergy, GI disease (particularly colitis) and seizure disorder. Renal impairment. Pregnancy and lactation.
","Haemodialysis patient: Repeat loading dose after each dialysis session.
+
+- CrCl <5 ml/min: 0.5-1 g 24-48 hrly.
+- CrCl 5-9 ml/min: 0.5-1 g 12-24 hrly.
+- CrCl 10-29 ml/min: 1-2 g 12-24 hrly.
+- CrCl 30-50 ml/min: 1-2 g 8-12 hrly.
+
",,,"As intermittent inj: Dissolve cefoxitin 1 g in 10 ml and 2 g in 10 ml or 20 ml of sterile water for inj.
As intermittent or continuous infusion: Add 50 ml or 100 ml of dextrose 5% or 10% inj, NaCl 0.9% inj, or other compatible IV soln to cefoxitin 1 g or 2 g.
","Store between 2-25° C.
",12
+218,Cefotaxime,cefotaxime-218,https://medex.com.bd/attachments/uAcr1T7l2cfhWoqTnIoR4rH5HrPcaP/cefotaxime-prescribing-information,Third generation Cephalosporins,Urinary tract infection,"Cefotaxime is indicated for the treatment of the following infections either before the infecting organism has been identified or when caused by bacteria of established sensitivity: Septicaemia Respiratory Tract Infections such as acute or chronic bronchitis, bacterial pneumonia, infected bronchiectasis ... Read more
Cefotaxime is indicated for the treatment of the following infections either before the infecting organism has been identified or when caused by bacteria of established sensitivity: Septicaemia Respiratory Tract Infections such as acute or chronic bronchitis, bacterial pneumonia, infected bronchiectasis, lung abscess and postoperative chest infections Urinary Tract Infections such as acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria Soft-tissue Infection such as cellulitis, peritonitis and wound infections Bone and Joint Infections such as osteomyelitis, septic arthritis Obstetric and gynaecological infections: such as pelvic inflammatory disease Gonorrhoea particularly when penicillin has failed or is unsuitable Other Bacterial Infections: meningitis and other sensitive infections suitable for parenteral antibiotic therapy Prophylaxis: The administration of Cefotaxime prophylactically may reduce the incidence of certain post operative infections in patients undergoing surgical procedures that are classified as contaminated or potentially contaminated or in clean operation where infection would have serious effects.
","Third generation Cephalosporins
","Cefotaxime binds to 1 or more of the penicillin binding proteins (PBPs) which inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell wall, thus inhibiting biosynthesis and arresting cell wall assembly resulting in bacterial cell death. Cefotaxime is a broad spectrum bactericidal 3rd generation parenteral cephalosporin antibiotic. Cefotaxime is exceptionally active against gram-negative organisms sensitive or resistant to first or second generation cephalosporins. It is similar to other cephalosporins in activity against gram-positive bacteria.
","Adults: The recommended dosage for mild to moderate infections is 1 gm every 12 hourly. However, dosage may be varied according to the severity of infection, sensitivity of causative organisms and condition of the patient. In severe infections dosage may be increased up to 12 gm daily given in 3 or 4 divided doses. For infections caused by sensitive Pseudomonas spp. daily doses of greater than 6 gm will usually be required
Children: The usual dosage range is 100-150 mg/kg/day in 2 to 4 divided doses. However, in very severe infections doses of up to 200 mg/kg/day may be required.
Neonates: The recommended dosage is 50 mg/kg/day in 2 to 4 divided doses. In severe infections 150-200 mg/kg/day, in divided doses, have been given.
Dosage in gonorrhoea: 500 mg as a single dose.
",,"Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.
","Cefotaxime is contraindicated in patients who have shown hypersensitivity to cefotaxime or the cephalosporin group of antibiotics.
","Adverse reactions to Cefotaxime have occurred relatively infrequently and have generally been mild and transient. Effects reported include candidiasis, rashes, fever, transient rises in liver transaminase and/or alkaline phosphatase and diarrhoea. As with all cephalosporins, pseudomembranous colitis may rarely occur during treatment. If this occurs the drug should be stopped and specific treatment instituted.As with other cephalosporins, changes in renal function have been rarely observed with high doses of Cefotaxime. Administration of high doses of cephalosporins particularly in patients with renal insufficiency may result in encephalopathy. Hypersensitivity reactions have been reported, these include skin rashes, drug fever and very rarely anaphylaxis.
","Although studies in animals have not shown any adverse effect on the developing foetus, the safety of Cefotaxime in human pregnancy has not been established. Consequently, Cefotaxime should not be administered during pregnancy especially during first trimester, without carefully weighing the expected benefit against possible risks. Cefotaxime is excreted in the milk.
","Cefotaxime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. Because high and prolonged antibiotic concentrations can occur from usual doses in patients with transient or persistent reduction of urinary output because of renal insufficiency, the total daily dosage should be reduced when Cefotaxime is administered to such patients. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organism. There is no clinical evidence supporting the necessity of changing the dosage of Cefotaxime in patients with even profound renal dysfunction.
","Dosage in renal impairment: Because of extra-renal elimination, it is only necessary to reduce the dosage of Cefotaxime in severe renal failure (GFR<5 ml/min = serum creatinine approximately 751 micromol/litre). After an initial loading dose of 1 gm, daily dose should be halved without change in the frequency of dosing. In all other patients, dosage may require further adjustment according to the course of infection and the general condition of the patient.
",,,,"Store below 25°C, protected from light and moisture. Use reconstituted solution immediately. Reconstituted solution is stable for up to 24 h if stored between 2° to 8°C.
",11
+1415,Cefoperazone Sodium,cefoperazone-sodium-1415,https://medex.com.bd/attachments/e8x4coKy1CPF3DEmFljEkzaLUH95hG/cefoperazone-sodium-prescribing-information,Third generation Cephalosporins,Urinary tract infection,"Cefoperazone is indicated for the treatment of the following infections when caused by susceptible organisms: Respiratory Tract Infections, Peritonitis & Other Intra-abdominal Infections, Bacterial Septicemia, Skin and Skin Structures Infections, Pelvic Inflammatory Disease, Endometritis & Other Infections of the Female Genital Tract, Urinary Tract Infections, Enterococcal Infections etc.
","Third generation Cephalosporins
","Cefoperazone is a bactericidal Cephalosporin antibiotic which is resistant to most beta-lactamases and active against a wide range of aerobic & anaerobic, Gram positive & Gram negative bacteria. The bactericidal action of Cefoperazone results from the inhibition of bacterial cell wall synthesis. Cefoperazone has a high degree of stability in the presence of beta-lactamases produced by most Gram negative pathogens. Cefoperazone is usually active against organisms which are resistant to other beta-lactam antibiotics because of beta-lactamase production.
","Sterile Cefoperazone Sodium can be administered by IM or IV injection (following dilution).
Adult: 2 to 4 grams per day administered in equally divided doses every 12 hours. In severe infections or infections caused by less sensitive organisms, the total daily dose and/or frequency may be increased. Patients have been successfully treated with a total daily dosage of 6-12 grams divided into 2,3, or 4 administrations ranging from 1.5 to 4 grams per dose. When treating infections caused by Streptococcus pyogenes, therapy should be continued for at least 10 days.
",,,"Cefoperazone is contraindicated in patients with known allergy to the Cephalosporin-class of antibiotics.
","Hypersensitivity: As with all Cephalosporins, hypersensitivity manifested by skin reactions (1 patient in 45), drug fever (1 in 260), or a change in Coombs’ test (1 in 60) has been reported. These reactions are more likely to occur in patients with a history of allergies, particularly to Penicillin.
","Pregnancy Category B.This drug should be used during pregnancy only if clearly needed. Only low concentrations of Cefoperazone is excreted in human milk. Although Cefoperazone passes poorly into breast milk of nursing mothers, caution should be exercised when Cefoperazone is administered to a nursing woman.
","Cefoperazone is extensively excreted in bile. The serum half-life of Cefoperazone is increased 2-4 fold in patients with hepatic disease and/or biliary obstruction. In general, total daily dosage above 4 gm should not be necessary in such patients. If higher dosages are used, serum concentrations should be monitored.
","Children use: Safety and effectiveness in children have not been established.
Geriatric use: Reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
",,,"Cefoperazone for intravenous or intramuscular use may be initially reconstituted with compatible solution. Solutions should be allowed to stand after reconstitution to allow any foaming to dissipate to permit visual inspection for complete solubilization. Vigorous and prolonged agitation may be necessary to solubilize Cefoperazone in higher concentrations (above 333 mg Cefoperazone/ml). The maximum solubility of Cefoperazone is approximately 475 mg Cefoperazone/ml of compatible diluent.
","Cefoperazone is to be stored in a dry place, below 25°C and protected from light prior to reconstitution. The reconstituted solution may be stored for 24 hours if kept in room temperature (below 25°C).
",11
+217,Cefixime Trihydrate,cefixime-trihydrate-217,https://medex.com.bd/attachments/Ry660BZmAuPanIOxJUU8IeUdFLALpc/cefixime-trihydrate-prescribing-information,Third generation Cephalosporins,Urethritis,"Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:
+
+- Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
+- Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
... Read more
Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:
+
+- Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
+- Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
+- Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
+- Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
+- Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.
+
","Third generation Cephalosporins
","Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.
","The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.
Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.
Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following
+
+- ½-1 year: 75 mg daily.
+- 1-4 years: 100 mg daily.
+- 5-10 years: 200 mg daily.
+- 11-12 years: 300 mg daily
+- In typhoid fever, dosage should be 10 mg/kg/day for 14 days.
+
+
Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.
",,"Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.
","It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.
","The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.
","There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.
","The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.
",,"Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.
",,,"Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.
",11
+215,Cefepime Hydrochloride,cefepime-hydrochloride-215,https://medex.com.bd/attachments/c1wKQih1Ph5rtOIlZ34DXE26nGUJLQ/cefepime-hydrochloride-prescribing-information,Fourth generation Cephalosporins,Urinary tract infection,"Cefepime is indicated for the treatment of the following infections caused by susceptible strains of the microorganisms:
+
+- Pneumonia (moderate to severe): caused by Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species.
... Read more
Cefepime is indicated for the treatment of the following infections caused by susceptible strains of the microorganisms:
+
+- Pneumonia (moderate to severe): caused by Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species.
+- Febrile Neutropenia: Cefepime as monotherapy is indicated for empiric treatment of febrile neutropenic patients. In patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. Insufficient data exist to support the efficacy of cefepime monotherapy in such patients.
+- Uncomplicated and Complicated Urinary Tract Infections (including pyelonephritis): caused by Escherichia coli or Klebsiella pneumoniae, when the infection is severe, or caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, when the infection is mild to moderate, including cases associated with concurrent bacteremia with these microorganisms.
+- Uncomplicated Skin and Skin Structure Infections: caused by Staphylococcus aureus (methicillin- susceptible strains only) or Streptococcus pyogenes.
+- Complicated Intra-abdominal Infections (used in combination with metronidazole): caused by Escherichia coli, viridians group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis.
+
","Fourth generation Cephalosporins
","Cephalosporins are bactericidal and have the same mode of action as other beta-lactam antibiotics (such as penicillins). Cephalosporins disrupt the synthesis of the peptidoglycan layer of bacterial cell walls. The peptidoglycan layer is important for cell wall structural integrity, especially in Gram-positive organisms. The final transpeptidation step in the synthesis of the peptidoglycan is facilitated by transpeptidases known as penicillin binding proteins (PBPs).
","Cefepime should be administered intravenously over approximately 30 minutes.
+
+- Moderate to Severe Pneumonia due to S. pneumoniae, *P. aeruginosa, K. pneumoniae, or Enterobacter species: 1-2 gm IV 12 hourly for 10 days.
+- Empiric therapy for febrile neutropenic patients: 2 gm IV 8 hourly for 7** days.
+- Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli, K. pneumoniae, or P. mirabilis*: 0.5-1 gm IV/IM*** 12 hourly for 7-10 days.
+- Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae*: 2 gm IV 12 hourly for 10 days.
+- Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes: 2 gm IV 12 hourly for 10 days.
+- Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by E. coli, viridans group streptococci, P. aeruginosa, K. pneumoniae, Enterobacter species, or B. fragilis: 2 gm IV 12 hourly for 7-10 days.
+
+
Note:*including cases associated with concurrent bacteremia.
**or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re evaluated frequently.
*** IM route of administration is indicated only for mild to moderate, uncomplicated or complicated UTls due to E. coli when the IM route is considered to be a more appropriate route of drug administration.
",,"Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with Cefepime because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.
","Cefepime is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillin, or other betalactum antibiotics.
","Cefepime is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillin, or other betalactum antibiotics.
","Pregnancy Category B. There are, however, no adequate and well-controlled studies of cefepime use in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefepime is excreted in human breast milk in very low concentrations (0.5 pg/ml). Caution should be exercised when cefepime is administered to a nursing woman.
","
+- Prescribing Cefepime in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
+- As with other antimicrobials, prolonged use of Cefepime may result in overgrowth of non susceptible microorganisms. Repeated evaluation of the patient's condition is essential.
+- Many cephalosporins, including cefepime, have been associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy. Prothrombin time should be monitored in patients at risk.
+- Cefepime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
+- Arginine has been shown to alter glucose metabolism and elevate serum potassium transiently when administered at 33 times the amount provided by the maximum recommended human dose of Cefepime. The effect of lower doses is not presently known.
+
","Pediatric Use (2 months up to 16 years): The maximum dose for pediatric patients should not exceed the recommended adult dose. The usual recommended dosage in pediatric patients up to 40 kg in weight for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia is 50 mg/kg/dose, administered every 12 hours (50 mg/kg/dose, every 8 hours for febrile neutropenic patients), for durations as given above.
Geriatric Use: Serious adverse events have occurred in geriatric patients with renal insufficiency given unadjusted doses of cefepime, including life-threatening or fatal occurrences of the following: encephalopathy, myoclonus, and seizures. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored.
Impaired Hepatic Function: No adjustment is necessary for patients with impaired hepatic function.
Impaired Renal Function: In patients with impaired renal function (creatinine clearance<60 ml/min), the dose of Cefepime should be adjusted to compensate for the slower rate of renal elimination.
","Patients who receive an overdose should be carefully observed and given supportive treatment. In the presence of renal insufficiency, hemodialysis, not peritoneal dialysis, is recommended to aid the removal of cefepime from the body. Accidental overdosing has occurred when large doses were given to patients with impaired renal function. Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and neuromuscular excitability.
",,"For IV the resulting solution should be injected directly into the vein over a period of three to five minutes or injected into the tubing of an administration set while the patient is receiving a compatible IV fluid.
Intravenous: Cefepime is compatible with Sterile Water for Injection. It is also compatible at concentrations between 1 mg/ml and 40 mg/ml with the following IV infusion fluids: 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, M/6 Sodium Lactate Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, Lactated Ringers and 5% Dextrose Injection.
Intramuscular: Cefepime is compatible with the following diluent such as: Sterile Water for Injection, 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol or 0.5% or 1% Lidocaine Hydrochloride.
500 mg (IV) vials for intravenous administration:
+
+- Amount of WFI to be added: 5 ml
+- Approximate available volume: 5.6 ml
+
+500 mg (IM) vials for intramuscular administration:
+
+- Amount of WFI to be added: 1.3 ml
+- Approximate available volume: 1.8 ml
+
+1 gm (IV) vials for Intravenous administration:
+
+- Amount of WFI to be added: 10 ml
+- Approximate available volume: 11.3 ml
+
+1 gm (IM) vials for intramuscular administration:
+
+- Amount of WFI to be added: 2.4 ml
+- Approximate available volume: 3.6 ml
+
+2 gm (IV) vials for Intravenous administration:
+
+- Amount of WFI to be added: 10 ml
+- Approximate available volume: 12.5 ml
+
","Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.
",13
+212,Cefditoren,cefditoren-212,https://medex.com.bd/attachments/zJAx6MQDnK2uKrvbyxvO0VRRlD0BHV/cefditoren-prescribing-information,Third generation Cephalosporins,Tonsillitis,"Cefditoren is indicated for the treatment of mild to moderate infections in adults and adolescents (12 years of age or older) which are caused by susceptible strains of the designated microorganisms in the conditions listed below:
+
+- Acute Bacterial Exacerbation of Chronic Bronchitis
+- Community Acquired Pneumonia
... Read more
Cefditoren is indicated for the treatment of mild to moderate infections in adults and adolescents (12 years of age or older) which are caused by susceptible strains of the designated microorganisms in the conditions listed below:
+
+- Acute Bacterial Exacerbation of Chronic Bronchitis
+- Community Acquired Pneumonia
+- Pharyngitis
+- Tonsillitis
+- Uncomplicated Skin and Skin-Structure Infections
+
","Third generation Cephalosporins
","Cefditoren is a preparation of Cefditoren Pivoxil which is a broad spectrum third generation cephalosporin antibiotic. Cefditoren is a prodrug which is hydrolyzed by esterases during absorption, and the drug is distributed in the circulating blood as active Cefditoren. Cefditoren has antibacterial activity against gram-positive and gram-negative pathogens. The bactericidal activity of Cefditoren results from the inhibition of cell wall synthesis via affinity for penicillin- binding proteins (PBPs). Cefditoren is stable in the presence of a variety of ß-lactamases, including penicillinases and some cephalosporinases.
","Cefditoren should be taken after meals.
Community-Acquired Pneumonia: 400 mg twice daily for 14 days.
Acute Exacerbation of Chronic Bronchitis: 400 mg twice daily for 10 days.
Pharyngotonsillitis and Acute Sinusitis: 200 mg twice daily for 10 days.
Uncomplicated Skin and Soft Structure Infections: 200 mg twice daily for 10 days.
",,"Antacids and Famotidine (intravenous administration) reduced the oral absorption of Cefditoren. As with other ß-lactam antibiotics, co-administration of probenecid with Cefditoren Pivoxil resulted in an increase in the plasma exposure of Cefditoren. Multiple doses of Cefditoren had no effect on the pharmacokinetics of ethinyl estradiol, the estrogenic component in most oral contraceptives.
","Cefditoren is contraindicated in patients with known allergy to the cephalosporin class of antibiotics or any of its components. Cefditoren contain sodium caseinate, a milk protein. Patients with milk protein hypersensitivity (not lactose intolerance) should not be administered Cefditoren.
","The most common side effects of Cefditoren are diarrhea, nausea, headache, abdominal pain, vaginal moniliasis, dyspepsia, vomiting, abnormal dreams, allergic reaction, anorexia, constipation, dizziness, dry mouth and fever.
","Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. Cefditoren should be used during pregnancy only if clearly needed. Animal studies show that Cefditoren excreted in breast milk. Caution should be exercised when Cefditoren is administered to nursing women.
","Cefditoren is not recommended when prolonged antibiotic treatment is necessary, since other pivalate-containing compounds have caused clinical manifestations of carnitine deficiency when used over a period of months. Prescribing Cefditoren in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
","Children: Use of Cefditoren is not recommended for pediatric patients less than 12 years of age. The safety and efficacy of Cefditoren tablets in this population, including any effects of altered carnitine concentration, have not been established.
Geriatric: No dose adjustments are necessary in geriatric patients with normal (for their age) renal function.
Patients with renal insufficiency: No dose adjustment is necessary for patients with mild renal impairment (ClCr: 50-80 mL/min/1.73 m2). It is recommended that not more than 200 mg BID be administered to patients with moderate renal impairment (ClCr: 30-49 mL/min/1.73 m2) and 200 mg QD be administered to patients with severe renal impairment (ClCr: <30 mL/min/1.73 m2 ). The appropriate dose in patients with end-stage renal disease has not been determined.
Patients with hepatic disease: No dose adjustments are necessary for patients with mild or moderate hepatic impairment.
","Information on Cefditoren overdosage in humans is not available. However, with other ß-lactam antibiotics, adverse effects following overdosage have included nausea, vomiting, epigastric distress, diarrhea, and convulsions. Hemodialysis may aid in the removal of Cefditoren from the body, particularly if renal function is compromised.
",,,"Store in a cool (below 25°C) and dry place protected from light.
",12
+211,Cefdinir,cefdinir-211,https://medex.com.bd/attachments/jMiHzu3B42f8difJVzRAEad67aL9Iz/cefdinir-capsules-prescribing-information,Third generation Cephalosporins,Uncomplicated cystitis,"Cefdinir is indicated for the treatment of Community Acquired Pneumonia, Acute Exacerbation of Chronic Bronchitis, Acute Maxillary Sinusitis, Pharyngitis, Tonsillitis, Uncomplicated Skin and Skin Structure, Infections
","Third generation Cephalosporins
","Cefdinir binds to 1 or more of the penicillin-binding proteins (PBPs) which inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell wall, thus inhibiting biosynthesis and arresting cell wall assembly resulting in bacterial cell death.
","Adult: 600 mg daily as a single or in 2 divided doses for 5-10 days.
Child: ≥6 months: 14 mg/kg daily as a single or in 2 divided doses. Max: 600 mg daily.
",,"Antacids: Cefdinir should be taken at least 2 hours interval of antacid administration.
Iron supplement: Cefdinir should be taken at least 2 hours interval of iron supplement administration.
Probencid: It inhibits the renal excretion of cefdinir.
","Cefdinir is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.
","Common side effects are Diarrhea, Vaginal moniliasis, Nausea & Vomiting, Headache, Rash etc.
","Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Following administration of single 600 mg doses, Cefdinir was not detected in human breast milk.
","Cefdinir, as with other broad-spectrum antibiotics, should be prescribed with caution in individuals with a history of colitis. In patients with transient or persistent renal insufficiency (creatinine clearance <30 ml/min), the total daily dose of Cefdinir should be reduced.
",,"Symptoms: Nausea, vomiting, epigastric distress, diarrhoea, convulsions.
Management: Haemodialysis may be useful in the event of a serious toxic reaction particularly if renal function is compromised.
",,,"Store between 20-25° C.
",11
+1454,Cefazolin Sodium,cefazolin-sodium-1454,https://medex.com.bd/attachments/quCiitCZmubgZF3nKmdvt7V6Cg0YEa/cefazolin-sodium-prescribing-information,First generation Cephalosporins,Urinary tract infection,"Cefazolin is indicated in the treatment of the following serious infections due to susceptible organisms: Respiratory Tract Infections, Urinary Tract Infections, Skin and Skin Structure Infections, Biliary Tract Infections, Bone and Joint Infections, Genital Infections, Septicemia, Endocarditis and Perioperative Prophylaxis.
","First generation Cephalosporins
","Cefazolin is a 1st generation broad spectrum parenteral Cephalosporin antibiotic.It interferes with the synthesis of bacterial cell wall by inhibiting transpeptidase enzyme. As a result the bacterial cell wall is weakened,the cell swells and then ruptures.
","Adult Dose
+
+- Moderate to severe infection: 500 mg to 1 gm for every 6 to 8 hours
+- Mild infections caused by susceptible Gram-positive cocci: 250 mg to 500 mg for every 8 hours
+- Acute uncomplicated urinary tract infections: 1 gm for every 12 hours
+- Pneumococcal pneumonia: 500 mg for every 12 hours
+- Severe life-threatening infections (e.g. Endocarditis, Septicemia): 1 gm to 1.5 gm for every 6 hours. In rare instances, doses up to 12 gm per day can be used
+
+
Perioperative Prophylactic Use: To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:
+
+- 1 gm IM or IV administered half hour to 1 hour prior to the start of surgery.
+- For lengthy operative procedures (e.g. 2 hours or more), 500 mg to 1 gm IM or IV during surgery.
+- 500 mg to 1 gm IM or IV every 6 to 8 hours for 24 hours postoperatively.
+
+In surgery where the occurrence of infection may be particularly devastating (e.g. open-heart surgery and prosthetic arthroplasty), the prophylactic administration may be continued for 3 to 5 days following the completion of surgery.
",,"Probenecid may decrease renal tubular secretion of Cephalosporins when used concurrently, resulting in increased and more prolonged Cephalosporin blood levels.
","Cefazolin is contraindicated in patients with known allergy to the Cephalosporin group of Antibiotics.
","Common side effects include:Injection site reactions (pain, swelling, skin rash, or a hard lump), diarrhea, stomach pain, stomach cramps, nausea, vomiting, loss of appetite, skin rash or itching, hives, white patches or sores inside the mouth or on the lips, vaginal itching or discharge,heartburn, gas,rectal itching,confusion, weakness, hypotension, drowsiness, headache and allergic reactions.
","Pregnancy Category B. Cefazolin is present in very low concentrations in the milk of nursing mothers.Caution should be exercised when Cefazolin is administered to a nursing woman.
","
+- As with all Cephalosporins, Cefazolin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly Colitis.
+- As with other β-lactam antibiotics, seizures may occur if inappropriately high doses are administered to patients with impaired renal function.
+
","Patients with Impaired Renal Function:
+
+- Creatinine clearance 35 to 54 ml/min: 1 unit dose (based on unit doses of 500 mg & 1 gm) Every 8 hours
+- Creatinine clearance 11 to 34 ml/min: ½ unit dose (based on unit doses of 500 mg & 1 gm) Every 12 hours
+- Creatinine clearance 10 ml/min: ½ unit dose (based on unit doses of 500 mg & 1 gm) Every 18 to 24 hours
+
+
Patients with Hepatic Insufficiency: No dosage adjustment is necessary in patients with hepatic insufficiency.
Pediatric Dose: In pediatric patients, a total daily dosage of 25 to 50 mg per kg of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderate infections. Total daily dosage may be increased to 100 mg per kg of body weight for severe infections. Safety for use in premature infants and in neonates has not been established.
",,,"The content of one vial is to be dissolved in 2 ml (for 500 mg IM/IV Injection) & 2.5 ml (for 1 gm IM/IV Injection) Water for Injection.
","After reconstitution, Cefazolin is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C). Reconstituted solution may range in color from pale yellow to yellow without a change in potency.
",12
+210,Cefadroxil Monohydrate,cefadroxil-monohydrate-210,https://medex.com.bd/attachments/ucMy6y3rGQovfeITQrPZNExH4dWwkd/cefadroxil-monohydrate-capsules-prescribing-information,First generation Cephalosporins,Urinary tract infection,"It is indicated for the treatment of upper respiratory tract infections (pharyngitis and tonsillitis) caused by Streptococcus pyogenes (group-A beta-hemolytic Streptococci) and Streptococcus pneumoniae; urinary tract infections caused by E. coli, Proteus mirabilis, and Klebsiella species and skin & ... Read more
It is indicated for the treatment of upper respiratory tract infections (pharyngitis and tonsillitis) caused by Streptococcus pyogenes (group-A beta-hemolytic Streptococci) and Streptococcus pneumoniae; urinary tract infections caused by E. coli, Proteus mirabilis, and Klebsiella species and skin & soft tissue infections caused by Staphylococci (including penicillinase producing bacteria) and Streptococci.
","First generation Cephalosporins
","Cefadroxil inhibits bacterial cell wall synthesis by binding to 1 or more of the penicillin-binding proteins (PBPs) which in turn inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis and arresting cell wall assembly resulting in bacterial cell death.
","Adult:
+
+- Pharyngitis and Tonsillitis: 1 g per day in one or two divided doses.
+- Urinary Tract Infections: 1 or 2 g per day in one or two divided doses.
+- Skin and Skin Structure Infections: 1 g per day in one or two divided doses.
+
+Children: 30 mg/kg daily in divided doses every 12 hours.
It may be taken with meals or on empty stomach. Administration with food may be helpful in diminishing potential gastrointestinal complaints.
",,"There is no significant drug interaction with other drugs.
","Cefadroxil is contraindicated in patients with a history of hypersensitivity to Cefadroxil or any of the ingredients of it.
","Generally Cefadroxil is well tolerated. However, the most commonly reported side effects are gastrointestinal disturbances and hypersensitivity phenomena.
","US FDA pregnancy category of Cefadroxil is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefadroxil have been shown to be excreted in human milk. So, caution should be exercised when Cefadroxil is administered during lactation.
","Use of this antibiotic may cause pseudomembranous colitis; so caution should be taken during diagnosis in patients who develop diarrhea in association with Cefadroxil therapy.
",,,,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",10
+209,Cefaclor Monohydrate,cefaclor-monohydrate-209,https://medex.com.bd/attachments/VH7x93HT3BjjWjG03fySkgJLD3fXx1/cefaclor-monohydrate-tablets-prescribing-information,Second generation Cephalosporins,Urinary tract infection,"Cefaclor is indicated in the treatment of the following infections: Otitis media, Lower respiratory tract infections, including pneumonia, bronchitis and acute exacerbation of chronic bronchitis, Upper respiratory tract infections, including pharyngitis and tonsillitis, Urinary tract infections, including pyelonephritis and cystitis, Skin and soft tissue infections, Sinusitis
","Second generation Cephalosporins
","Cefaclor is a second generation cephalosporin antibiotic which has stability against b-lactamase inactivation and possesses a broad spectrum of activity. Cefaclor is active against the following organisms in vitro: Alpha and beta haemolytic Streptococci, Staphylococci; including coagulase-positive, coagulase negative and penicillinase-producing strains, Streptococcus pneumoniae, Streptococcus pyogenes (Group A b-haemolytic Streptococci), Branhamella catarrhalis, Escherichia coli, Proteus mirabilis, Klebsiella species Haemophilus influenzae, including ampicillin-resistant strains. Cefaclor is generally effective in the eradication of Streptococci from the nasopharynx.
","Adult-
+
+- Usual dose: 250 mg 8 hrly.
+- Bronchitis & pneumonia: 250 mg tid.
+- Sinusitis: 500 mg tid for 10 days.
+- Pneumonia & other more severe infections: Max: 4 gm/day for 28 days.
+- Acute gonococcal urethritis: 3 gm as a single dose combined with probenecid 1 gm.
+
+Children-
+
+- Recommended dose: 20 mg/kg/day in divided doses 8 hrly.
+- Bronchitis & pneumonia: 20 mg/kg/day in divided doses tid.
+- Serious infections, sinusitis, otitis media & infections: caused by less susceptible organisms 40 mg/kg/day in divided doses. Max: 1 gm/day.
+
","May be taken with or without food.
","The nephrotoxicity of aminoglycoside antibiotics such as gentamicin and tobramicin may be enhanced by any cephalosporin. Therefore, one should be cautious in concomitant use of these categories of drugs.
","Cefaclor is contraindicated in patients with known allergy to the Cephalosporin group of antibiotics.
","Gastro-intestinal: Diarrhoea, nausea and vomiting have been reported. Hypersensitivity: Allergic reactions such as eruptions, pruritis and urticaria have been observed. These reactions usually subside upon discontinuation of therapy. Serum sickness like reactions have been reported.
Haematological: Eosinophilia, thrombocytopenia, transient lymphocytosis and leucopenia may occur rarely. Hepatic: Transient hepatitis and cholestatic jaundice, slight elevation in AST, ALT or alkaline phosphate values have been reported rarely.
Renal: Reversible interstitial nephritis has occurred rarely, also slight elevations in blood urea or serum creatinine or abnormal urinalysis.
Central Nervous System: Reversible hyperactivity, nervousness, confusion, hypertonia, dizziness, hallucinations and somnolence have been reported rarely.
","There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Small amounts of Cefaclor have been detected in mother's milk. The effect on nursing infants is not known. Caution should be exercised when Cefaclor is administered to a nursing woman.
","Cefaclor should be administered with caution in the presence of markedly impaired renal function. Dosage adjustments for patients with moderate or severe renal impairment are not usually required.
",,"Symptoms: Nausea, vomiting, epigastric distress and diarrhoea would be anticipated.
Treatment: Unless 5 times the normal total daily dose has been ingested, gastrointestinal decontamination will not be necessary. General management may consist of supportive therapy.
",,,"Store in a cool and dry place. Protect from light.
",12
+2033,Casirivimab + Imdevimab,casirivimab-imdevimab-2033,https://medex.com.bd/attachments/xXhXlwQmSmnWMIwQtngy3munNYBPAi/casirivimab-imdevimab-prescribing-information,,,"This is indicated for:
+
+- Treatment of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.
+- Prevention of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg.
+
",,"Casirivimab (IgG1κ) and imdevimab (IgG1λ) are two recombinant human monoclonal antibodies which are unmodified in the Fc regions. Casirivimab and imdevimab bind to non-overlapping epitopes of the spike protein receptor-binding domain (RBD) of SARS-CoV-2. This prevents RBD binding to the human ACE2 receptor, so preventing virus entry into cells.
","The dosage in adult patients and in adolescent patients 12 years of age and older weighing at least 40 kg is 600 mg of casirivimab and 600 mg of imdevimab administered as a single intravenous infusion or by subcutaneous injection.
Post-exposure prophylaxis: The dosage in adult patients and in adolescent patients 12 years of age and older weighing at least 40 kg is 600 mg of casirivimab and 600 mg of imdevimab administered as a single intravenous infusion or by subcutaneous injection. Casirivimab with imdevimab should be given as soon as possible after contact with a case of COVID-19.
Pre-exposure prophylaxis: The initial dose in adult patients and in adolescent patients 12 years of age and older weighing at least 40 kg is 600 mg of casirivimab and 600 mg of imdevimab administered as a single intravenous infusion or by subcutaneous injection. Subsequent doses of 300 mg of casirivimab and 300 mg of imdevimab administered as a single intravenous infusion or by subcutaneous injection may be given every 4 weeks until prophylaxis is no longer required. There are no data on repeat dosing beyond 24 weeks (6 doses).
",,,"Hypersensitivity to the active substances or to any of the excipients.
",,"Pregnancy: There are no or limited amount of data from the use of casirivimab and imdevimab in pregnant women. Animal studies have not been performed with respect to reproductive toxicity. Human immunoglobulin G1 (IgG1) antibodies are known to cross the placenta. It is unknown whether the potential transfer of casirivimab and imdevimab provides any treatment benefit or risk to the developing foetus. However, as casirivimab and imdevimab directly target the spike protein of SARS-CoV-2 and in view of lack of cross reactivity with reproductive or foetal tissues in the tissue cross reactivity studies, negative effects on developing foetus are not expected. This drug should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the foetus considering all associated health factors. If a woman becomes pregnant while taking this medicine, the individual should be informed that any potential risk to the foetus is unknown.
Breast-feeding: It is unknown whether casirivimab and imdevimab are excreted in human milk, but maternal IgG is known to be transferred to milk during the first days after birth. As casirivimab and imdevimab directly target the spike protein of SARS-CoV-2 and in view of low systemic absorption after oral ingestion of antibodies, administration of this drug whilst breast-feeding can be considered when clinically indicated.
","Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Subcutaneous administration for treatment of COVID-19: The clinical efficacy of this drug when administered by the subcutaneous route for treatment of COVID-19 has not been evaluated in clinical trials. The pharmacokinetics of casirivimab and imdevimab in the first 48 hours after subcutaneous administration of 600 mg of each monoclonal antibody indicate lower serum exposures compared to intravenous administration of the same dose. It is unknown whether differences in initial systemic exposure result in differences in clinical efficacy. It is recommended that the subcutaneous route of administration is used only if intravenous administration is not feasible and would lead to a delay in treatment.
Hypersensitivity reactions including anaphylaxis: Hypersensitivity reactions, including anaphylaxis, have been reported with administration of casirivimab and imdevimab. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care.
Infusion-related reactions: Infusion-related reactions (IRRs) have been observed with intravenous administration of casirivimab and imdevimab. IRRs observed in clinical studies were mostly moderate in severity and were typically observed during or within 24 hours of infusion. The frequently reported signs and symptoms for these reactions included nausea, chills, dizziness (or syncope), rash, urticaria and flushing. However, infusion-related reactions may present as severe or life threatening events and may include other signs and symptoms. If an IRR occurs, the infusion may be interrupted, slowed or stopped.
","
+- Elderly: No dosage adjustment is required.
+- Renal impairment: No dosage adjustment is required.
+- Hepatic impairment: No dosage adjustment is required (see section 5.2).
+- Pediatric population: The safety and efficacy of casirivimab and imdevimab in children <12 years of age has not yet been established. No data are available.
+
","Doses up to 4 000 mg each of casirivimab and imdevimab (approximately 7-times the recommended dose) have been administered in clinical trials. The safety profile for 8 000 mg intravenous was not substantially different to that for the recommended dose. There is no known specific antidote for casirivimab and imdevimab overdose. Treatment of overdose should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
",,,"Store in a refrigerator (2°C-8°C). Do not freeze. Do not shake. Keep the vials in the original carton in order to protect from light.
",9
+208,Carvedilol,carvedilol-208,https://medex.com.bd/attachments/Kj1uK23PsjqBRpNfjmXOXjH72sdxGi/carvedilol-prescribing-information,Alpha adrenoceptor blocking drugs,Myocardial infarction,"Carvedilol is indicated for the treatment of mild, moderate or severe heart failure of ischemic or cardiomyopathic origin, in conjunction with digitalis, diuretics and ACE inhibitor, to reduce the progression of disease as evidenced by cardiovascular death, cardiovascular hospitalization, or the need ... Read more
Carvedilol is indicated for the treatment of mild, moderate or severe heart failure of ischemic or cardiomyopathic origin, in conjunction with digitalis, diuretics and ACE inhibitor, to reduce the progression of disease as evidenced by cardiovascular death, cardiovascular hospitalization, or the need to adjust other heart failure medications. Carvedilol may be used in patients unable to tolerate an ACE inhibitor. Carvedilol may be used in patients who are not receiving digitalis, hydralazine or nitrate therapy.
","Alpha adrenoceptor blocking drugs, Beta-adrenoceptor blocking drugs, Beta-blockers
","Carvedilol is a cardiovascular drug whose main pharmacological action is non-selective antagonism of β-adrenergic receptors but which also possesses appreciable a-adrenergic antagonistic activity. It also has antiproliferative properties and is a scavenger of reactive free oxidant radicals. It is used in the treatment of hypertension, angina pectoris and congestive heart failure.
","In hypertension: initially, 12.5 mg once daily, increased after 2 days to the usual dose of 25 mg once daily; if necessary the dose may be further increased at intervals of at least 2 weeks to maximum 50 mg daily in single or divided doses. In elderly patients, the initial dose of 12.5 mg daily may provide satisfactory control.
In angina pectoris: the recommended dose for initiation of therapy is 12.5 mg twice daily for the first 2 days. Thereafter, the recommended dosage is 25 mg twice daily. For elderly patients, the maximum daily dose is 50 mg daily in divided doses.
In heart failure: initially, 3.125 mg twice daily (with food) may be given, the dose may be increased at intervals of at least 2 weeks to 6.25 mg twice daily, then to 12.5 mg twice daily, then to 25 mg twice daily. The dose may be increased to the highest dose tolerated, maximum 25 mg twice daily in patients less than 85 kg body-weight and 50 mg twice daily in patients over 85 kg.
",,"Digoxin: In normal healthy volunteers a single dose of carvedilol taken together with a single dose of digoxin resulted in significantly increased levels of digoxin 24 hours later. Patients with congestive heart failure stabilized on digoxin have been given carvedilol concomitantly without any adverse effects. Increased monitoring of digoxin is recommended when initiating, adjusting, or discontinuing the dose of carvedilol.
Rifampin: Pretreatment with rifampin resulted in a 60% decrease in Cmax and AUC.
Warfarin: Carvedilol did not alter the in vitro plasma protein binding of warfarin.
Clonidine: β-receptor antagonists potentiate the pressor reaction which may follow the sudden withdrawal of treatment with clonidine although, in theory, the a-blocking action of carvedilol should modify the pressure rise.
","Carvedilol is contraindicated in patients with decompensated heart failure requiring intravenous inotropic therapy, bronchial asthma or related bronchospastic conditions, second or third-degree AV block, sick sinus syndrome (unless a permanent pacemaker is in place), cardiogenic shock or severe bradycardia.
","Postural hypotension, dizziness, headache, fatigue, gastro-intestinal disturbances, bradycardia; occasionally diminished peripheral circulation, peripheral oedema and painful extremities, dry mouth, dry eyes, eye irritation or disturbed vision, impotence, disturbances of micturition, influenza-like symptoms, rarely angina, AV block, exacerbation of intermittent claudication or Raynaud's phenomenon, allergic skin reactions, exacerbation of psoriasis, nasal stuffiness, wheezing, depressed mood, sleep disturbances, paresthesia, heart failure, changes in liver enzymes, thrombocytopenia, leukopenia are also reported.
","Carvedilol should not be used during breast-feeding, since no studies have been performed in lactating women and animal studies have shown that carvedilol is excreted in breast milk. Safety and efficacy in children have not been established with carvedilol. Carvedilol should not be used during pregnancy as no studies have been performed in this group. Animal studies have shown that carvedilol crosses the placental barrier. No information is available on the safety and efficacy of Carvedilol use in neonates.
","Take caution in hepatic impairment and in heart failure monitor clinical status for 2-3 hours after initiation and after increasing each dose. Before increasing dose ensure that the renal function and heart failure are not deteriorating
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+1621,Carmellose Sodium,carmellose-sodium-1621,https://medex.com.bd/attachments/a8NPPfXFoAQItpUHlWAWPHmQP4Ca5g/carmellose-sodium-prescribing-information,Drugs for Dry eyes,Eye irritation,"Carmellose Sodium is a substitute for tears, and contains the lubricant called carmellose sodium. It is used for the treatment of the symptoms of dry eye (such as soreness, burning, irritation or dryness) caused by you not producing enough tears to keep the eye wet.
","Drugs for Dry eyes
",,"The recommended dose is 1-2 drops of Carmellose Sodium in the affected eye/each affected eye, 4 times a day or as often as needed. You do not need to remove contact lenses before using Carmellose Sodium. Make sure that the single-dose container is intact before use. The solution should be used immediately after opening. To avoid contamination or possible eye injury, do not let the open-end of the single-dose container touch your eye or anything else. Wash your hands before use.
",,"Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription. If you are using other eye drops, leave at least 15 minutes between putting in the other drops and Carmellose Sodium.
","If you are hypersensitive (allergic) to carmellose sodium or any of the other ingredients of this medicine.
","Common side effects are eye irritation (including burning and discomfort), eye pain, itchy eyes, visual disturbance.
","You can use Carmellose Sodium if you are pregnant and when you are breast-feeding.
","If irritation, pain, redness or changes in vision occur or if you feel your condition is getting worse, stop taking this medicine and consult your doctor or pharmacist.
",,,,,"Keep this medicine out of the sight and reach of children. Do not store above 25°C.
",9
+1437,Carisoprodol,carisoprodol-1437,https://medex.com.bd/attachments/1eNyIVtukUSRVYv0RqVOhI4Od4O5dP/carisoprodol-prescribing-information,Locally acting Skeletal Muscle Relaxants,Sedation,"Carisoprodol is indicated for-
+
+- The relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
+- Sedation and decrease anxiety in patients with severe pain.
+- Used as an adjunct in physical therapy in injuries.
+
","Locally acting Skeletal Muscle Relaxants
","Carisoprodol is a GABA-A receptor indirect agonist with CNS chloride channel conductance effect. GABA receptor agonists typically produce sedative effect and may also cause other effects such as anxiolytic, anticonvulsant and muscle relaxant. Metabolite of Carisoprodol, Meprobamate, has anxiolytic and sedative properties. Carisoprodol decreases the impulses from brain and spinal cord to the muscle. This causes the muscle to relax and hence decrease the spasm. It has no direct action on muscle itself.
","Adults (18 years and older): The recommended dose of Carisoprodol is 250 mg three times daily and at bedtime (4 times daily). The recommended maximum duration of Carisoprodol use is up to two or three weeks. Caution should be taken in patients with renal and hepatic impairment and also with reduced CYP2C19 activity.
",,"
+- Caution should be exercised with patients who take other CNS depressants (eg. alcohol, benzodiazepines, opioids, tricyclic antidepressants) with Carisoprodol.
+- Co-administration of CYP2C19 inhibitors (Omeprazole, Fluvoxamine) with Carisoprodol could result in increased exposure of Carisoprodol. Co-administration of CYP2C19 inducers (Rifampin) with Carisoprodol could result in decreased exposure of arisoprodol.
+
","Carisoprodol is contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate.
","Common side effects are drowsiness, dizziness and headache.
","Pregnancy category C. Maternal use of Carisoprodol may lead to reduced or less effective infant feeding (due to sedation) and/or decresed milk production. Caution should be exercised when Carisoprodol is administered to a nursing woman.
","Due to sedative properties, may impair ability to perform hazardous tasks such as driving or operating machinery. Additive sedative effects when used with other CNS depressants including alcohol. Cases of Drug Dependence, Withdrawal, and Abuse. Seizures
",,"Overdosage of Carisoprodol commonly produces CNS depression. Death, coma, respiratory depression, hypotension, seizures have been reported with Carisoprodol overdosage. Basic life support measures should be instituted in Carisoprodol overdose. Induced emesis is not recommended due to the risk of CNS and respiratory depression. Gastric lavage should be considered soon after ingestion (within one hour). Circulatory support should be administered with volume infusion and vasopressor agents if needed. Seizures should be treated with intravenous benzodiazepines and the reoccurrence of seizures may be treated with phenobarbital. In cases of severe CNS depression, airway protective reflexes may be compromised and tracheal intubation should be considered for airway protection and respiratory support.
",,,"Store in cool and dry place at room temperature 20°-25°C, away from direct light. Keep out reach of children.
",11
+207,Carboxymethylcellulose Sodium + Hypromellose,carboxymethylcellulose-sodium-hypromellose-207,,Drugs for Dry eyes,Dry eye,"This medication is used to relieve the dryness and pain associated with reduced or abnormal tear production.
","Drugs for Dry eyes
","Carboxymethylcellulose Sodium & Hypromellose both of them are polymer in nature. It is a clear and colorless aqueous solution. This medication lubricates the surface of the eye in the same way as natural tears. It can therefore be used to relieve the dryness and pain associated with reduced or abnormal tear production.
","For Adults and Children: Instill 1 or 2 drops in the affected eye(s) as needed.
",,,"Known sensitivity or allergy to any ingredient of the formulation.
","Common side effects are blurred vision, matting or stickiness of eyelashes.
","Carboxymethylcellulose Sodium & Hypromellose have not been shown to cause birth defects or other problems during pregnancy and breastfeeding.
","If you experience eye pain, changes in vision, continued redness or irritation of the eye or if your symptoms continue for more than 3 days or become worse, check with your doctor.
","This drug does not cause different side effects or problems in children than it does in adults.
",,,,"Store in a cool, dry place and protected from light, Keep out of the reach of children, Do not use more than 4 weeks after opening.
",10
+206,Carboxymethylcellulose Sodium + Glycerin,carboxymethylcellulose-sodium-glycerin-206,https://medex.com.bd/attachments/xdjj3bVhUBkp8tjPZmRgbB1pdlHh3c/carboxymethylcellulose-sodium-glycerin-prescribing-information,Drugs for Dry eyes,Irritation and discomfort of the eye,"This Sterile Eye Drops is indicated for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
","Drugs for Dry eyes
","The combination of Carboxymethylcellulose Sodium and Glycerin relieves the symptoms of dry eye in two ways. Firstly it provides lubricating and hydrating protective shield on the ocular surface of the eye and then it works below the tear film to provide protection to the cornea.
","Instill 1 drop in the affected eyes as needed. It can be used in children.
",,,"It is contraindicated in patients with known hypersensitivity to any ingredient of this formulation.
","Vision may be temporarily blurred when this product is first used. Also, minor burning/ stinging/ irritation may temporarily occur.
","Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Carboxymethylcellulose Sodium and Glycerin should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: Carboxymethylcellulose Sodium or Glycerin has not been measured in human milk. Caution should be exercised when the combination of Carboxymethylcellulose Sodium and Glycerin is administered to a nursing mother.
","Consult doctor if irritation, eye pain or visual changes worsen or persist beyond 72 hours.
",,,,,"Store below 30°C. Protect from light. Do not use longer than 1 month after 1st opening. Do not freeze.
",9
+1966,Bitter Melon [Korola],bitter-melon-korola-1966,,Herbal and Nutraceuticals,,"Regulate Blood sugar level, Improve pancreatic & liver function, boost immunity & natural source of vitamin C.Helps in easy digestion
","Herbal and Nutraceuticals
","It is a slender, climbing annual vine with long stalked leaves & yellow,solitary male and female flowers borne on the leaf axils. The fruit, usually oblong, resembles a warty gourd or a small cucumber. The young fruit is emerald green, turning to orange-yellow when ripe. At maturity, the fruit splits into three irregular valves that curl backwards and release numerous reddishbrown or white seeds encased in scarlet arils. Bitter melon grows in topical areas, including parts of amazone, East Africa, India,Asia & the Caribbean.
","1-2 Capsules twice daily 20-30 minutes after meals or as advised by the registered physician.
",,"If Bitter Melon and an antidiabetic agent are used together, blood glucose level should be monitored regularly.
","Bitter Melon has proven to be relatively safe & effective in controlled clinical studies. No absolute contraindication.
","A balanced formulation of bitter melon is well tolerated. No Significant side effect has been observed in proper dosage.
","Bitter melon should not be used in pregnant & lactating mother.
",,,,,,"Keep out of reach of the children, keep away from direct sunlight. Keep store in a cool and dry place.
",9
+1535,Biotin,biotin-1535,,Herbal and Nutraceuticals,Hair loss,"Biotin is indicated in-
+
+- Hair loss
+- Weak, brittle, splitting or soft nails
+- Eczema & dermatitis.
+
","Herbal and Nutraceuticals
","Biotin is an essential vitamin that is also known as vitamin H. It is involved in vital physiological function like fatty acid synthesis, amino acid catabolism and gluconeogenesis. It acts as a cofactor in the enzymatic carboxylation of pyruvate and acetyl-CoA. Biotin influences the growth and differentiation of epidermal cells and is therefore important for the formation and renewal of the skin, hair and nails. It functions as a coenzyme for mitochondrial carboxylases in hair roots and improves the keratin structure. Biotin deficiency may result in hair loss and a variety of systemic symptoms such as dermatitis, and aciduria. Biotin is one of the most prescribed nutritional supplements for any kind of hair loss.
","Biotin dose varies depending on disease condition and age group.
In adults: Generally 1-3 tablets per day or as advised by the physician.
In children: biotin deficiency affects between 1 week and 2 years of age and usually exhibits seizures, hypotonia, developmental delay, ataxia, hyperventilation, and coma. In this case, 5-10 tablets daily, crushed and mixed with water or any kind of fruit juice or as advised by the physician.
+
Recommended dietary allowance:
+
Infants-
+
+- 0-6 months: 5 mcg/day
+- 7-12 months: 6 mcg/day
+
+Children-
+
+- 1-3 years: 8 mcg/day
+- 4-8 years: 12 mcg/day
+
+Males and females-
+
+- 9-13 years: 20 mcg/day
+- 14-18 years: 25 mcg/day
+- ≥19 years: 30 mcg/day
+
+
Pregnancy: 30 mcg/day
+
Lactation: 35 mcg/day
+
",,"There are indications that anticonvulsant drugs lower the plasma level of biotin. Antibiotic use may decrease the biotin contribution to the body made by the microflora of the large intestine. Excessive consumption of raw egg whites interferes with biotin absorption.
","Contraindicated in patients with known hypersensitivity to any of the ingredients.
","Well tolerated in the recommended dose. No biotin toxicity has been reported in individuals supplemented with as much as 200 mg orally or 20mg intravenously per day.
","Sufficient clinical data is not available to use in pregnant women and lactating mother.
",,,,,,"Store in a cool and dry place, away from light and moisture. Keep out of reach of children.
",9
+1526,Bilberry fruit [Vaccinium myrtillus L],bilberry-fruit-vaccinium-myrtillus-l-1526,,Herbal and Nutraceuticals,Night blindness,"Bilberry fruit is indicated in Retinopathy (hypertensive and diabetic), Night blindness, Cataracts, Macular degeneration, Retinitis pigmentosa and Hemorrhagic retinopathy.
","Herbal and Nutraceuticals
","Bilberry extract is used to treat Retinopathy, Cataracts, Macular degeneration, Retinitis pigmentosa, Hemorrhagic retinopathy. Bilberry anthocyanins regenerate rhodopsin are indicated in the treatment of poor night vision and cataracts. Bilberry is also used to treat microcirculatory disorders which include varicose veins, atherosclerosis, venous insufficiency.
MECHANISM OF ACTION:
+
+- Inhibits enzymatic cleavage of collagen by the enzymes secreted by leucocytes during Inflammation.
+- By inhibiting retinal phosphoglucomutase and glucose-6-phosphatase it confers retinal protection.
+- Reduces microvascular impairments due to ischemic reperfusion injury, with preservation of endothelium, attenuation of leukocyte adhesion and improvement of capillary perfusion.
+- Produces dose dependent inhibition of platelet aggregation and clot retraction.
+- Decreases basement membrane collagen hydrolysis by significantly reducing permeability of the blood-brain barrier and increases recovery rate of the BBB caused by permeability-increasing agents.
+
","One 160 mg capsule should be taken 2-3 times daily or as per the instruction of a physician.
",,"None known. Very high doses ( more than 170 mg anthocyanins daily for 30-60 days) may interact with warfarin or other antiplatelet drugs.
","None known
","None known.
","No known restriction.
",,,,,,"Store at a cool, dry place below 30°C temperature and away from direct sunlight. Keep the medicine out of the reach of children.
",9
+1717,Belgiri [Bael fruit + Connessi bark],belgiri-bael-fruit-connessi-bark-1717,,Herbal and Nutraceuticals,Shigellosis,"This is indicated in-
+
+- Diarrhoea
+- Amoebiasis (Amoebic dysentery)
+- Shigellosis (Bacillary dysentery)
+- Giardiasis
+- Irritable bowel syndrome (IBS)
+- Gastroenteritis
+- Peptic ulcer
+- Flatulence
+- Indigestion
+- Hyperacidic complications
+
","Herbal and Nutraceuticals
","This preparation is a unique combination of Bael (Aegle marmelos) fruit and Connessi (Holarrhena antidysenterica) bark, which is highly effective in diarrhoea, dysentery (Amoebic & Bacillary dysentery), giardiasis and helminthiasis. This preparation relieves drug induced gastrointestinal troubles. This preparation acts against various pathogenic microbes such as bacteria like Shigella sp., Escheriachia coli, Salmonella sp., etc. parasites like Entamoeba histolytica, Giardia lamblia and some worm’s like Ascaris lumbricoides, Ancylostoma duodenale, Taenia solium etc. This preparation is well tolerated & safe for both children & adults.
","Adults: 2 teaspoonfuls 3-4 times daily.
Children: 1 teaspoonful 3-4 times daily or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in the therapeutic dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1686,Barsina,barsina-1686,,Herbal and Nutraceuticals,Vitiligo,"Barsina is indicated in Vitiligo or Leucoderma.
","Herbal and Nutraceuticals
","Barsina is a unique unani medicine, prepared with Psoralea (Psoralia corylifolia), Chebulic Myrobalan (Terminalia chebula), Ginger (Zingiber officinale) and other valuable natural ingredients which are highly effective in vitiligo.
","1-2 capsule(s) twice daily or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been reported in therapeutic dosage.
",,"Keep out of reach of the children.
",,,,,"Store in cool and dry place, protect from light.
",8
+1893,Adhatoda vasica + Centella asiatica,adhatoda-vasica-centella-asiatica-1893,,,,"This syrup is indicated in-
+
+- Cough
+- Dry Cough
+- Bronchitis
+- Chronic lung infection
+- Rhinitis
+- Flu & headache
+
",,"Adhatoda vasica Contains alkaloid vasicine which has expectorant qualities so it is useful for bronchitis and other chest conditions of upper respiratory tract. The soothing action of vasac helps irritation in the throat and the expectorant action helps loosen phlegm deposits in the airway and expels it out. Honey reduces mucus secretion and cough.
","Children: 1/2-1 teaspoonful 2-3 times daily.
Adult: 2-4 teaspoonful 2-3 times daily.
Or as directed by the registered physician.
",,"There is no data available.
","It is contraindicated in patients known to have hypersensitivity to the drug or any of its components.
","There is no data available.
","The safety of the Syrup in pregnancy & lactation has not been established. Therefore, it should be used with caution during pregnancy & lactation.
","There is no data available.
",,,,,"Keep out of reach of children. Keep away from direct sunlight. Store in a cool and dry place.
",9
+23,Adenosine,adenosine-23,https://medex.com.bd/attachments/bO1j7PKXCn0h1YJ5AFIQHxuYokfvVI/adenosine-injection-for-intravenous-use-prescribing-information,Paroxysmal supraventricular tachycardia (PSVT),Supraventricular tachycardia,"Intravenous Adenosine is indicated for the following: Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome).
","Paroxysmal supraventricular tachycardia (PSVT)
","This preparation is a sterile, nonpyrogenic solution for rapid bolus intravenous injection. Adenosine injection slows conduction time through the A-V node, can interrupt the reentry pathways through the A-V node, and can restore normal sinus rhythm in patients with paroxysmal supraventricular tachycardia.
","Adult:
+
+- Initial dose: 6 mg given as rapid IV bolus (administered over 1-2 second period).
+- Repeat administration: If the first dose does not result in elimination of the supraventricular tachycardia within 1-2 minutes, 12 mg should be given as rapid intravenous bolus. This 12 mg dose may be repeated for second time if required.
+
+
Pediatric: The dosages used in neonates, infants, children and adolescents were equivalent to those administered to adults on a weight basis.
+
+- Body weight < 50 kg: Initial dose - 0.05 to 0.1 mg/kg as a rapid IV bolus given either centrally or peripherally. A saline flush should follow.
+- Body weight > 50 kg: The adult dose is recommended. Doses greater than 12 mg are not recommended for adult and pediatric patients.
+
+
Repeat administration: If conversion of PSVT does not occur within 1-2 minutes, additional bolus injections of adenosine can be administered at incrementally higher doses, increasing the amount given by 0.05 to 0.1 mg/kg. A saline flush should follow. This process should continue until sinus rhythm is established or a maximum single dose of 0.3 mg/kg is used.
",,"Intravenous Adenosine injection has been effectively administered in the presence of other cardioactive drugs, such as Quinidine, beta- adrenergic blocking agents, Calcium channel blocking agents and angiotensin converting enzyme inhibitors without any change in the adverse reaction profile. Digoxin and Verapamil use may be rarely associated with ventricular fibrillation when combined with Adenosine. Because of the potential for additive or synergistic depressant effects on the SA and AV nodes, however, Adenosine should be used with caution in the presence of these agents. The use of Adenosine in patients receiving Digitalis may be rarely associated with ventricular fibrillation. The effects of Adenosine are antagonized by Methylxanthines, such as, Caffeine and Theophylline.
","Intravenous Adenosine is contraindicated in:
+
+- Second- or third-degree A-V block (except in patients with a functioning artificial pacemaker).
+- Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker).
+- Known hypersensitivity to Adenosine.
+
","Cardiovascular: Facial flushing, headache, sweating, palpitations, chest pain, hypotension. Respiratory: Shortness of breath/dyspnea, chest pressure, hyperventilation, head pressure.
Central Nervous System: Lightheadedness, dizziness, tingling in arms, numbness, apprehension, blurred vision, burning sensation, heaviness in arms, neck and back pain.
Gastrointestinal: Nausea, metallic taste, tightness in throat, pressure in groin. In post-market clinical experience with Adenosine, cases of prolonged asystole, ventricular tachycardia, ventricular fibrillation, transient increase in blood pressure, bradycardia, hypotension, atrial fibrillation and bronchospasm, in association with Adenosine use, have been reported.
","US FDA pregnancy category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
",,,"The half-life of Adenosine is less than 10 seconds. Thus, adverse effects are generally rapidly self-limiting. Treatment of any prolonged adverse effects should be individualized and be directed toward the specific effect. Methylxanthines, such as, Caffeine and Theophylline, are competitive antagonists of Adenosine.
",,,"Store in cool dry place protected from light. Keep out of reach of children. Do not refrigerate as crystallization may occur. If crystallization has occurred, dissolve crystals by warming to room temperature. The solution must be clear at the time of use.
",10
+15,Adefovir Dipivoxil,adefovir-dipivoxil-15,https://medex.com.bd/attachments/fSQXfx8JfqKXVLNbDnw17jpXfWFIo8/adefovir-dipivoxil-prescribing-information,Hepatic viral infections (Hepatitis B),Hepatitis B virus,"Adefovir Dipivoxil is indicated for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
","Hepatic viral infections (Hepatitis B)
","Adefovir dipivoxil is a diester prodrug of adefovir. Adefovir is an acyclic nucleotide analog with activity against human hepatitis B virus (HBV). Adefovir is phosphorylated to the active metabolite, adefovir diphosphate, by cellular kinases. Adefovir diphosphate inhibits HBV DNA polymerase (reverse transcriptase) by competing with the natural substrate deoxyadenosine triphosphate and by causing DNA chain termination after its incorporation into viral DNA. The approximate oral bioavailability of adefovir from a 10 mg single dose is 59%. In vitro binding of adefovir to human plasma or human serum proteins is 4%. Adefovir is excreted through renal route by a combination of glomerular filtration and active tubular secretion.
","The recommended dose of Adefovir in chronic hepatitis B patients with adequate renal function is 10 mg, once daily, taken orally, without regard to food.
",,"The pharmacokinetics of adefovir was unchanged when adefovir dipivoxil was coadministered with lamivudine, trimethoprim/ sulfamethoxazole and acetaminophen. When adefovir dipivoxil was co-administered with ibuprofen (800 mg three times daily), increases in adefovir Cmax (33%), AUC (23%) and urinary recovery were observed due to higher oral bioavailability of adefovir.
","Adefovir dipivoxil is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product.
","The most common side effects of adefovir dipivoxil are weakness, headache, stomach pain and nausea. Severe acute exacerbations of hepatitis have been reported in patients who have discontinued anti-hepatitis B therapy, including therapy with adefovir dipivoxil. In patients at risk of or having underlying renal dysfunction, chronic administration of adefovir dipivoxil may result in nephrotoxicity. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals.
","Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Adefovir dipivoxil should be used during pregnancy only if clearly needed and after careful consideration of the risks and benefits. It is not known whether adefovir is excreted in human milk. Mothers should be instructed not to breast-feed if they are taking adefovir dipivoxil.
","Patients who discontinued adefovir dipivoxil should be monitored at repeated intervals over a period of time for hepatic function. The patients at risk of or having underlying renal dysfunction should be monitored closely for renal function and may require dose adjustment.
","Pediatric use: Safety and effectiveness in pediatric patients have not been established.
Geriatric use: In general, caution should be exercised when prescribing to elderly patients since they have greater frequency of decreased renal or cardiac function due to concomitant disease or other drug therapy.
Dose Adjustment in Renal Impairment: the dosing interval of Adefovir should be adjusted in patients with baseline creatinine clearance <50 ml/min using the following suggested guidelines:
+
+- CrCl ≤ 50 ml/min: 10 mg
+- CrCl 20-49 ml/min: 10 mg every 48 hours
+- CrCl 10-19 ml/min: 10 mg every 72 hours
+- Haemodialysis patients: 10 mg every 7 days following dialysis
+
","Doses of adefovir dipivoxil 500 mg daily for 2 weeks and 250 mg daily for 12 weeks have been associated with gastrointestinal side effects. If overdose occurs the patient must be monitored for evidence of toxicity and standard supportive treatment applied as necessary.
",,,"Store at cool and dry place. Protect from light and moisture. Keep all the medicines out of the reach of children.
",12
+11,Adapalene + Benzoyl peroxide,adapalene-benzoyl-peroxide-11,https://medex.com.bd/attachments/yYWdAqOpdDlc48cRIlaaYoTfKYlu6L/adapalene-benzoyl-peroxide-gel-01-25-prescribing-information,Topical retinoid and related preparations,Acne vulgaris,"Adapalene & Benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
","Topical retinoid and related preparations
","Adapalene & Benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that Adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes. Adapalene binds with specific retinoic acid nuclear receptors that normalize the differentiation of follicular epithelial cells resulting in decreased microcomedone formation. Benzoyl peroxide is an oxidizing agent with bacteriocidal and keratolytic effects.
","Apply a thin film of Adapalene & Benzoyl peroxide gel to affected areas of the face and/or trunk once daily after washing. Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek). Avoid the eyes, lips and mucous membranes. Adapalene & Benzoyl peroxide is not for oral, ophthalmic, or intravaginal use.
Pediatric use: The safety and effectiveness of Adapalene and Benzoyl peroxide gel in pediatric patients under the age of 12 years have not been established.
",,"Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. No formal drug-drug interaction studies were conducted.
","Should not be administered to individuals who are hypersensitive to any of its component.
","Erythema, scaling, dryness, and stinging/ burning may occur. Most commonly reported adverse events are dry skin, contact dermatitis, application site burning, application site irritation, and skin irritation.
","There are no well-controlled trials in pregnant women treated with Adapalene and Benzoyl peroxide. Animal reproduction studies have not been conducted with the combination gel or Benzoyl peroxide. Furthermore, such studies are not always predictive of human response; therefore, this preparation should be used during pregnancy only if the potential benefit justifies the risk to the fetus. It is not known whether Adapalene or Benzoyl peroxide is excreted in human milk following use. Caution should be exercised when administered to a nursing woman.
","Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided.
",,,,,"Store in a cool (below 25°C) and dry place protected from light and moisture. Keep out of the reach of children. Keep the tube tightly closed after use.
",10
+14,Adapalene,adapalene-14,https://medex.com.bd/attachments/RwK8nOhYrxQDVk4EOC8ycBoCgMsIWT/adapalene-gel-03-prescribing-information,Topical retinoid and related preparations,Keratosis pilaris,"Adapalene cream or gel is indicated for topical treatment of acne vulgaris.
","Topical retinoid and related preparations
","Adapalene acts on retinoid receptors that are commonly found in the skin of face, back and chest. Biochemical and pharmacological studies have demonstrated that Adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of that represent important features in the pathology of acne vulgaris. Adapalene binds with specific retinoic acid nuclear receptors that normalize the differentiation of follicular epithelial cells resulting in decreased microcomedone formation. Absorption of Adapalene through human skin is low.
","Adapalene 0.1%: It should be applied to the affected areas of skin, once daily at night-time.
Adapalene 0.3%: It should be applied to the entire face and any other affected areas of the skin, once daily in the evening.
Children below 12 years of age: Safety and effectiveness in children below 12 years of age have not been established.
","A thin film of gel or cream should be applied to the skin areas where lesions present, using enough to cover the entire affected areas lightly.
","Concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, products with high concentrations of alcohol, astringents, spices or lime) should be approached with caution. Exercise particular caution in using preparations containing sulfur, resorcinol or salicylic acid in combination with Adapalene. If any of these preparations have been used, it is advisable not to start therapy with Adapalene until the effects of such preparations in skin have subsided. If combined use of both medications is important, it is better to use in two different times.
","Adapalene should not be administered to individuals who are hypersensitive to Adapalene or any of its components.
","Erythema, scaling, dryness, pruritus, burning sensation, skin irritation, stinging unburn, acne flares, etc. are commonly seen during the first month of therapy but usually lessen with continued use of the medication.
","Use Adapalene during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in breast milk. Exercise caution when administering Adapalene to a nursing mother.
","Adapalene should not be applied to cuts, abrasions, eczematous or sunburned skin.
",,,,,"Store in a cool (below 25°C) and dry place protected from light and moisture. Keep out of the reach of children. Keep the tube tightly closed after use.
",11
+1705,Aloe + Black Pepper + Henbane,aloe-black-pepper-henbane-1705,,Herbal and Nutraceuticals,Obesity,"This is indicated in-
+
+- Constipation
+- Flatulence
+- Anorexia
+- Colic
+- Obesity
+- Hypercholesterolaemia
+
","Herbal and Nutraceuticals
","This is a unique unani medicine prepared with various natural ingredients, such as Aloe (Aloe baradensis), Black pepper (Piper nigrum), Henbane (Hyoscyamus niger) and other natural medicinal ingredients. The synergistic action of these natural ingredients makes this tablet, an effective remedy for flatulence, constipation and colic. It discharges the excessive stool from the bowels and increases appetite. It also helps to reduce obesity.
","1-2 tablet(s) daily with milk at bed time or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in proper dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+243,Chloramphenicol + Lidocaine Hydrochloride,chloramphenicol-lidocaine-hydrochloride-243,,Aural Anti-bacterial preparations,Otic infections,"Acute bacterial ear infections
","Aural Anti-bacterial preparations
","Chloramphenicol inhibits bacterial protein synthesis by binding to 50s subunit of the bacterial ribosome, thus preventing peptide bond formation by peptidyl transferase. It has both bacteriostatic and bactericidal action against H. influenzae, N. meningitidis and S. pneumoniae.
Lidocaine is an amide type local anaesth. It stabilises the neuronal membrane and inhibits Na ion movements, which are necessary for conduction of impulses. In the heart, lidocaine reduces depolarisation of the ventricles during diastole and automaticity in the His-Purkinje system. Duration of action potential and effective refractory period are also reduced.
","Otic/Aural Otitis externa: Instill 2-3 drops into the ear bid-tid.
",,"Decreased effects of iron and vitamin B12 in anaemic patients. Phenobarbitone and rifampin reduce efficacy of chloramphenicol. Impairs the action of oral contraceptives.
Potentially Fatal: Increases the effect of oral anticoagulants, oral hypoglycaemic agents, phenytoin. Avoid concomitant administration with drugs that depress bone marrow function.
","History of hypersensitivity or toxic reaction to the drug; Perforated ear drum. Herpes simplex and other virul conditions of the eye or ear, mycosis.
","Ototoxicity.
","Pregnancy Category C & B. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
","Avoid prolonged use. Discontinue immediately if local hypersensitivity reactions occur.
",,,,,,9
+1847,Chloramphenicol (Oral),chloramphenicol-oral-1847,https://medex.com.bd/attachments/gEIn0WQ3XkxFOHfD2FNVR8BMIifu0l/chloramphenicol-oral-prescribing-information,Macrolides,Bacterial infections,"Chloramphenicol is an antibiotic that is clinically useful for, and should be reserved for, serious infections caused by organisms susceptible to its antimicrobial effects when less potentially hazardous therapeutic agents are ineffective or contraindicated. However, chloramphenicol may be chosen to ... Read more
Chloramphenicol is an antibiotic that is clinically useful for, and should be reserved for, serious infections caused by organisms susceptible to its antimicrobial effects when less potentially hazardous therapeutic agents are ineffective or contraindicated. However, chloramphenicol may be chosen to initiate antibiotic therapy on the clinical impression that one of the conditions below is believed to be present. In vitro sensitivity tests should be performed concurrently so that the drug may be discontinued as soon as possible if less potentially dangerous agents are indicated by such tests. The decision to continue use of chloramphenicol, rather than another antibiotic when both are suggested by in vitro studies to be effective against a specific pathogen, should be based upon severity of the infection, susceptibility of the pathogen to the various antimicrobial drugs, and the efficacy of the various drugs in the infection
","Macrolides
","In vitro, chloramphenicol exerts mainly a bacteriostatic effect on a wide range of Gram-negative and Gram positive bacteria and is active against rickettsiae, the lymphogranuloma-psittacosis group and Vibrio cholerae. It is particularly active against Salmonella typhi and Haemophilus influenzae. The mode of actions is through interference or inhibition of protein synthesis in intact cells and cell-free systems. Antagonism has been demonstrated in vitro between chloramphenicol, erythromycin, clindamycin and lincomycin. Chloramphenicol is rapidly absorbed from the GI tract. Chloramphenicol palmitate is hydrolyzed in the GI tract and is absorbed as free chloramphenicol.
Following oral administration of a single one gram dose of chloramphenicol base to healthy adults, average peak plasma chloramphenicol concentrations of about 11 mcg/ml were attained with 1-3 hours. Cumulative dosing gave a peak of 18 mcg/ml after the fifth dose of one gram, every 6 hours. Mean serum levels were 8-14 mcg/ml over a 48 hour period.
Most of the drug is excreted in the urine. Despite the small proportion of unchanged drug excreted in the urine, the concentration of free chloramphenicol in the urine is relatively high. From 8% to 12% of the antibiotic is excreted as free chloramphenicol. The remainder is excreted as inert metabolites, mainly glucuronate. Small amounts of active drug are found in bile and feces. Chloramphenicol diffuses rapidly, but its distribution is not uniform. Highest concentrations are found in liver and kidney, and lowest concentrations are found in brain and cerebrospinal fluid (CSF). Chloramphenicol enters CSF even in the absence of meningeal inflammation, appearing in concentrations about half of those found in the blood.
","Chloramphenicol, like other potent drugs, should be prescribed at recommended doses known to have therapeutic activity. Inhibition of the majority of sensitive organisms may be expected at concentrations of 5 to 20 mcg/ml. The desired concentration of active drug in serum should fall within this range over most of the treatment period. Dosage of 50 mg/kg/day divided into 4 doses at intervals of 6 hours will usually achieve and sustain levels of this order.
Except in certain circumstances (e.g. premature infants and neonates and individuals with hepatic or renal impairment) lower doses may not achieve these concentrations. Close observation of the patient should be maintained and in the event of any adverse reactions, dosage should be reduced or the drug discontinued, if other factors in the clinical situation permit.
Adults: should receive 50 mg/kg/day in divided doses [approximately one 250 mg capsule per each 4.5 kg (10 lbs) of body weight or one 500 mg capsule per each 9 kg (20 lbs) of body weight] in divided doses at 6 hour intervals. In exceptional cases, patients with infections due to moderately resistant organisms may require increased dosage up to 100 mg/kg/day to achieve serum levels inhibiting the pathogen, but these high doses should be decreased as soon as possible.
Adults with impairment of hepatic or renal function, or both, may have reduced ability to metabolize and excrete the drug. In instances of impaired metabolic processes, dosages should be adjusted accordingly.
Pediatric patients: Dosage of 50 mg/kg/day divided at 6 hour intervals is effective against most susceptible organisms. Severe infections (eg., bacteremia or meningitis), especially when adequate cerebrospinal fluid concentrations are desired, may require dosage up to 100 mg/kg/day; however, it is recommended that dosage be reduced to 50 mg/kg/day as soon as possible. Children with impaired hepatic or renal function may retain excessive amounts of the drug.
Newborn infants: A total of 25 mg/kg/day in 4 equal doses at 6-hour intervals usually produces and maintains concentrations in serum and tissues adequate to control most infections for which the drug is indicated.
",,"Chloramphenicol has been shown to retard the biotransformation of tolbutamide, phenytoin, and dicoumarol in man. Chloramphenicol should be used with caution if administered concomitantly with lincomycin, clindamycin, or erythromycin. In vitro experiments have demonstrated that binding sites for erythromycin, lincomycin, clindamycin and chloramphenicol overlap and competitive inhibition may occur. Rifampin therapy can reduce Chloramphenicol concentrations.
","Chloramphenicol is contraindicated in individuals with a history of hypersensitivity and/or toxic reaction to the product or its components. It must not be used in the treatment of trivial infections or where it is not indicated, as in colds, viral influenza, infections of the throat or as a prophylactic agent to prevent bacterial infections.
",,,"It is essential that adequate hematologic functions be closely monitored during treatment with the drug. While hematologic determinations may detect early peripheral hematologic changes, such as leukopenia, reticulocytopenia, or granulocytopenia, before they become irreversible, such determinations cannot be relied on to detect bone marrow depression prior to development of aplastic anemia
",,"Levels exceeding 25 mcg/ml are frequently considered toxic. Chloramphenicol toxicity can be evidenced by serious hemopoietic effects such as aplastic anemia, thrombocytopenia, leukopenia, as well as increasing serum iron levels, nausea, vomiting and diarrhea. In the case of serious overdosage, charcoal hemoperfusion may be effective in removing chloramphenicol from plasma. Exchange transfusion is of questionable value following massive overdosage, especially in neonates and infants.
",,,"Store in a cool dry place. Keep bottle securely closed. Protect from light.
",9
+237,Chloramphenicol (Ophthalmic),chloramphenicol-ophthalmic-237,https://medex.com.bd/attachments/7cizMA26ckUVYBFrwM4pAlGUM2uhDi/chloramphenicol-ophthalmic-capsules-suspension-prescribing-information,Macrolides,Whipple’s disease,"Chloramphenicol is indicated for the treatment of ocular infections involving the conjunctiva and/or cornea caused by chloramphenicol-susceptible organisms. Such as Staphylococcus aureus, Streptococcus pneumoniae, E.coli, H. influenzae, Klebsiella/Enterobacter spp, Moraxella lacunata, and Neisseria species.
","Ear Anti-Infectives & Antiseptics, Eye Anti-Infectives & Antiseptics, Macrolides
","Chloramphenicol is a broad-spectrum bacteriostatic antibiotic which acts through the inhibition of bacterial protein synthesis by interfering with the transfer of activated amino acids from soluble RNA to ribosomes.
","Adult and Children: Instill 1 or 2 drops in the conjunctival sac 4-6 times per day for the first 72 hours and then every 4 hours thereafter. Treatment should be continued for approximately 7 days, but should not be continued for more than 3 weeks without re-evaluation by the physician.
",,"Chymotrypsin may be inhibited if given simultaneously with Chloramphenicol.
","It is contraindicated in individuals with a history of hypersensitivity to Chloramphenicol or any ingredients of the preparation.
","The systemic adverse reaction has not been observed within short-term topical use of Chloramphenicol. The most frequently reported adverse reactions have been burning, stinging, conjunctival hyperemia, blood dyscrasia, allergic or inflammatory reactions, vesicular and maculopapular dermatitis.
","Safety for use in pregnancy and lactation has not been established. Therefore, use only when considered essential by the physicians.
","Chloramphenicol ophthalmic solution should never be given for minor infections or for prophylaxis. Repeated course and prolonged treatment should be avoided. Blood dyscrasias (granulocytopenia, thrombocytopenia and moderate anaemia) may occur after prolonged ophthalmic use.
",,"Accidental ingestion of the medicine is unlikely to cause any toxicity due to low content of antibiotic.
",,,"Store in a cool (between 2°C-8°C) and dry place, protect from light, keep out of reach of children. Do not touch the dropper tip to the surface since this may contaminate the solution. Do not use after 30 days of the first opening.
",11
+236,Chlorambucil,chlorambucil-236,https://medex.com.bd/attachments/5sOGUmqZit5a0uTcCIKwZiKaHnp0g7/chlorambucil-prescribing-information,Cytotoxic Chemotherapy,Waldenstrom's macroglobulinaemia,"Hodgkin's disease, certain forms of non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, Waldenstrom's macroglobulinaemia.
","Cytotoxic Chemotherapy
","Chlorambucil produces its anti-cancer effects by interfering with DNA replication and damaging the DNA in a cell. The DNA damage induces cell cycle arrest and cellular apoptosis via the accumulation of cytosolic p53 and subsequent activation of Bax, an apoptosis promoter.
Chlorambucil alkylates and cross-links DNA during all phases of the cell cycle, inducing DNA damage via three different methods of covalent adduct generation with double-helical DNA:
+
+- Attachment of alkyl groups to DNA bases, resulting in the DNA being fragmented by repair enzymes in their attempts to replace the alkylated bases, preventing DNA synthesis and RNA transcription from the affected DNA.
+- DNA damage via the formation of cross-links which prevents DNA from being separated for synthesis or transcription.
+- Induction of mispairing of the nucleotides leading to mutations.
+
+The precise mechanisms by which Chlorambucil acts to kill tumor cells are not yet completely understood.
","Hodgkin's disease: 200 mcg/kg/day for 4-8 wk.
Non-Hodgkin's lymphoma: 100-200 mcg/kg/day for 4-8 wk. Maintenance: Reduced daily dosage of intermittent courses of treatment.
Chronic lymphocytic leukaemia: Initially, 150 mcg/kg/day until the total leukocyte count falls to 10,000 microliter. Treatment may be resumed 4 wk after at a dose of 100 mcg/kg/day.
Waldenstrom's macroglobulinaemia: Starting dose of 6-12 mg daily until leucopenia occurs followed by 2-8 mg daily.
","Should be taken on an empty stomach: Ensure adequate hydration. Swallow whole, do not chew/crush.
",,"Pregnancy (1st trimester) & lactation.
","Bone marrow suppression, seizures in childn with nephrotic syndrome, nausea, vomiting, diarrhoea, oral ulceration. Rarely, irreversible bone marrow failure, allergic reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, seizures, movement disorders, interstitial pulmonary fibrosis, interstitial pneumonia, hepatotoxicity, jaundice, sterile cystitis, drug fever
","Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Monitor FBC closely. Bone marrow suppression reversible only if withdrawn early enough. Should not be given to patients who have recently undergone radio- or chemotherapy. In lymphocytic infiltration of bone marrow or hypoplastic bone marrow, max daily dose is 0.1 mg/kg. Childn with nephrotic syndrome, patients on high pulse dosing regimens, history of seizure disorders. Renal or hepatic impairment. Ensure adequate contraceptive precautions. Pregnancy.
",,,,,,9
+1290,Cetuximab,cetuximab-1290,https://medex.com.bd/attachments/EOmmYcKdCQqiqXDHpAfHUhvR8trNut/cetuximab-prescribing-information,Targeted Cancer Therapy,Head & neck cancer,"Squamous Cell Carcinoma Of The Head And Neck (SCCHN): Cetuximab is indicated in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck.
Cetuximab is indicated in ... Read more
Squamous Cell Carcinoma Of The Head And Neck (SCCHN): Cetuximab is indicated in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck.
Cetuximab is indicated in combination with platinum-based therapy with 5-FU for the first-line treatment of patients with recurrent locoregional disease or metastatic squamous cell carcinomaof the head and neck.
Cetuximab, as a single agent, is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck for whom prior platinum-based therapy has failed.
K-Ras Wild-Type, EGFR-Expressing Colorectal Cancer: Cetuximab is indicated for the treatment of K-Ras wild-type, epidermal growth factor receptor (EGFR)- expressing, metastatic colorectal cancer (mCRC) as determined by FDA-approved tests for this use
+
+- In combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for first-line treatment
+- In combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy
+- As a single agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.
+
","Targeted Cancer Therapy
","Cetuximab is a recombinant human/mouse chimeric monoclonal antibody. It binds specifically to the epidermal growth factor receptor (EGFR), thus competitively inhibiting the binding of epidermal growth factor (EGF) and other ligands. This blocks phosphorylation and activation of receptor-associated kinases, thus inhibiting cell growth, inducing apoptosis and decreases matrix metalloproteinase and vascular EGF production.
","Squamous Cell Carcinoma Of The Head And Neck:
+
Cetuximab in combination with radiation therapy or in combination with platinum-based therapy with 5-FU:
+
+- The recommended initial dose is 400 mg/m2 administered one week prior to initiation of a course of radiation therapy or on the day of initiation of platinum-based therapy with 5-FU as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min). Complete Cetuximab administration 1 hour prior to platinum-based therapy with 5-FU.
+- The recommended subsequent weekly dose (all other infusions) is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) for the duration of radiation therapy (6–7 weeks) or until disease progression or unacceptable toxicity when administered in combination with platinum-based therapy with 5-FU. Complete Cetuximab administration 1 hour prior to radiation therapy or platinumbased therapy with 5-FU.
+
+
Cetuximab monotherapy:
+
+- The recommended initial dose is 400 mg/m2 administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min).
+- The recommended subsequent weekly dose (all other infusions) is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity.
+
+
Colorectal Cancer:
+
+- Determine EGFR-expression status using FDA-approved tests prior to initiating treatment. Also confirm the absence of a Ras mutation prior to initiation of treatment with Cetuximab.
+- The recommended initial dose, either as monotherapy or in combination with irinotecan or FOLFIRI (irinotecan, 5-fluorouracil, leucovorin), is 400 mg/m2 administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min). Complete Cetuximab administration 1 hour prior to FOLFIRI.
+- The recommended subsequent weekly dose, either as monotherapy or in combination with irinotecan or FOLFIRI, is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity. Complete Cetuximab administration 1 hour prior to FOLFIRI.
+
+
Recommended Premedication: Premedicate with an H1 antagonist (eg, 50 mg of diphenhydramine) intravenously 30–60 minutes prior to the first dose; premedication should be administered for subsequent Cetuximab doses based upon clinical judgment and presence/severity of prior infusion reactions.
","Do not administer cetuximab as an intravenous push or bolus. Administer via infusion pump or syringe pump. Do not exceed an infusion rate of 10 mg/min. Administer through a low protein binding 0.22-micrometer in-line filter.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The solution should be clear and colorless and may contain a small amount of easily visible, white, amorphous, cetuximab particulates. Do not s hake or dilute.
",,,"Fatigue, pain, headache, fever, confusion, anxiety, insomnia, chills, rigors, depression. Acneiform rash, rash, dry skin, pruritus, nail changes, hypomagnesaemia, abdominal pain, constipation, diarrhoea, vomiting, nausea, wt loss, weakness, bone pain.
","Pregnancy: category C. Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether Cetuximab is secreted in human milk. IgG antibodies, such as Cetuximab, can be excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Cetuximab, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If nursing is interrupted, based on the mean half-life of cetuximab, nursing should not be resumed earlier than 60 days following the last dose of Cetuximab.
","Infusion rate should be reduced if patient exhibits signs of toxicity. Discontinue treatment if there is severe infusion reactions. Caution when used in patients with history of coronary artery disease, heart failure and arrhythmias. Monitor serum electrolytes during and after (for at least 8 wk) cetuximab therapy. Exposure to sunlight may worsen skin reactions. Risk of interstitial lung disease in patients with preexisting lung disease. Dose should be modified if there is occurrence of severe acneiform rash, refer to product insert/SPG for dosing guidelines.
","Dose modification in cases of severe acneiform rash (grade 3 or 4):
+
+- 1st occurrence: Delay infusion by 1-2 wk. If improvement, continue at 250 mg/m2; discontinue if no improvement.
+- 2nd occurrence: Delay infusion by1-2 wk. If improvement, continue at reduced dose of 200 mg/m2; discontinue if no improvement.
+- 3rd occurrence: Delay infusion by 1-2 wk. If improvement, continue at reduced dose of 150 mg/m2; discontinue if no improvement. 4th occurrence: Discontinue therapy.
+
","The maximum single dose of cetuximab administered is 1000 mg/m2 in one patient. No adverse events were reported for this patient.
",,,"Store vials under refrigeration at 2° to 8° C. Do not freeze.
",11
+235,Cetrorelix Acetate,cetrorelix-acetate-235,https://medex.com.bd/attachments/BLv1EmLeKAm8cn30UZvXH1SIY2HR79/cetrorelix-acetate-prescribing-information,Drugs affecting (inhibiting) gonadotrophin,In vitro fertilization,"Cetrorelix is indicated for assisted reproductive technologies
","Drugs affecting (inhibiting) gonadotrophin
","Cetrorelix, a synthetic decapeptide analog of naturally occurring gonadorelin, is a gonadorelin antagonist. It competitively blocks gonadorelin receptors on the anterior piyuitary gonadotroph and the subsequent transduction pathway, inducing a rapid, reversible suppression of gonadotrophin secretion.
","Adult: 250 mcg/day, given either in the morning beginning on the day 5 or 6 of ovarian stimulation or in the evening beginning on day 5, and continued until ovulation induction.
",,,"Hypersensitivity. Moderate to severe renal or hepatic impairment. Women with severe allergic conditions. Pregnancy and lactation.
","Mild and transient reactions at Inj site, nausea, headache, ovarian hyperstimulation syndrome, systemic hypersensitivity reactions.
","Pregnancy Category X. Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
","Women with active allergic conditions or a history of allergies; childn; elderly >65 yrs
",,,,,"Store cetrorelix acetate at room temperature, between 15 to 30° C
",9
+1477,Cetirizine Hydrochloride (Ophthalmic),cetirizine-hydrochloride-ophthalmic-1477,https://medex.com.bd/attachments/tigmskbt7Ght7tOpb3zD8V48RJEQBb/cetirizine-hydrochloride-ophthalmic-prescribing-information,Ophthalmic Anti-allergic preparations,Itching,"Cetirizine 0.24% ophthalmic solution is indicated for the treatment of ocular itching associated with allergic conjunctivitis.
","Ophthalmic Anti-allergic preparations
","Cetirizine, an antihistamine, is a histamine-1 (H1) receptor antagonist. Its effects are mediated via selective inhibition of H1 histamine receptors. The antihistaminic activity of cetirizine has been documented in a variety of animal and human models. In vivo and ex vivo animal models have shown negligible anticholinergic and antiserotonergic activity. In vitro receptor binding studies have shown no measurable affinity for other than H1 receptors.
In healthy subjects, bilateral topical ocular dosing of one drop of cetirizine ophthalmic solution 0.24% resulted in a mean cetirizine plasma Cmax of 1.7 ng/mL following a single dose and 3.1 ng/mL after twice-daily dosing for one week. The observed mean terminal half-life of cetirizine was 8.6 hours following a single dose and 8.2 hours after twice-daily dosing of Cetirizine for one week.
","Adults and children (age 2 years and above): The recommended dosage is to instill one drop in the affected eye(s) twice daily (approximately 8 hours apart).
",,,,"The most common adverse reactions are ocular hyperemia, instillation site pain and visual acuity reduction.
","Pregnancy: There is no adequate or well-controlled study with Cetirizine 0.24% ophthalmic solution in pregnant women. It should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is not known whether the systemic absorption resulting from topical ocular administration of Cetirizine could produce detectable quantities in human breast milk. There is no adequate information regarding the effects of Cetirizine on breastfed infants, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for this drug and any potential adverse effects on the breastfed child from Cetirizine.
","Care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle to prevent contaminating the tip and solution. Keep the bottle closed when not in use. Patients should be advised not to wear a contact lens if their eye is red. Remove contact lenses prior to instillation of the drug. Lenses may be reinserted after 10 minutes following the drug administration.
","Pediatric use: The safety and effectiveness have been established in pediatric patients two years of age and older.
Geriatric use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
",,,,"Do not store above 30⁰C. Do not freeze. Protect from light. Do not use more than 4 weeks after opening. Keep out of the reach of children.
",9
+234,Cetirizine Hydrochloride,cetirizine-hydrochloride-234,https://medex.com.bd/attachments/1hcJhQcplogszKCNAnFDxWPMWTqUxv/cetirizine-hydrochloride-tablets-prescribing-information,Sedating Anti-histamine,Urticaria,"It is indicated for the relief of symptoms associated with seasonal & perennial allergic rhinitis. It is also indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria and allergen induced asthma.
","Sedating Anti-histamine
","Cetirizine Hydrochloride is a potent H1 receptor antagonist without any significant anticholinergic and antiserotonic effects. At pharmacologically active dose levels, it has almost no drowsiness effect and does not cause behavioral changes. It inhibits the histamine-mediated early phase of the allergic reaction and also reduces the migration of inflammatory cells and the release of mediators associated with the late phase of the allergic reaction.
Pharmacokinetics: Cetirizine 10 mg achieves peak plasma concentrations of 257 mcg/L within one hour of administration (980 mcg/L in children). Food does not affect the extent of absorption, but it may slightly reduce the rate. Peak blood levels 0.3 micrograms/ml are reached between thirty & sixty minutes after administration of 10 mg dose of Cetirizine. Its plasma half-life is approximately 11 hours. Absorption is very consistent from one subject to the next. Its renal clearance is 30 ml/minute and the excretion half-life is approximately nine hours.
","Adults and Children 6 years and older: 1 tablet or 2 teaspoonfuls daily (or 1 teaspoonful twice daily).
Children 2-6 years: 1 teaspoonful once daily or 1/2 teaspoonful twice daily.
Children 6 months to 2 years : 1/2 teaspoonful once daily. The dose in children 12-23 months of age can be increased to a maximum dose as 1/2 teaspoonful every 12 hours.
",,"No clinically significant drug interactions have been found with Theophylline, Azithromycin, Pseudoephedrine, Ketoconazole or Erythromycin and with other drugs.
","It is contraindicated in patients with a history of hypersensitivity to Cetirizine or hydroxyzine.
","The most common side effects that occurred more frequently on Cetirizine is somnolence.
","US FDA Pregnancy Category of Cetirizine Hydrochloride is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cetirizine Hydrochloride has been shown to be excreted in human milk. So, caution should be exercised when Cetirizine Hydrochloride is administered to a nursing woman.
","Caution should be exercised when driving a car or operating a heavy machinery.
",,,,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",10
+233,Cetalkonium Chloride + Choline Salicylate,cetalkonium-chloride-choline-salicylate-233,https://medex.com.bd/attachments/GsU6zECRDpmCSNN85e6s1N64n5G6jg/cetalkonium-chloride-choline-salicylate-prescribing-information,Non-steroidal Anti-inflammatory Drugs (NSAIDs),Mouth ulcers,"This is indicated for the fast relief of pain, discomfort and inflammation caused by Mouth ulcer/Aphthous ulcer/Canker sore, Cold sore/Fever blister, Denture sore, Irritation from braces, Gum swelling, and sore spots due to orthodontic device.
","Non-steroidal Anti-inflammatory Drugs (NSAIDs), Preparations for Oral Ulceration & Inflammation
","Choline salicylate has an analgesic & anti-inflammatory effect. Like salicylic acid Choline salicylate has no antithrombotic activity. The pharmacological actions of choline salicylate are thought to be primarily mediated through inhibition of prostaglandin production. Cetalkonium chloride is an antiseptic, being bactericidal towards both Gram-positive and Gram-negative organisms.
Absorption: Choline salicylate is absorbed from the gut
Distribution: Throughout extracellular water and most tissues
Plasma Half-life: 2-4 hours
Excretion: Mainly in the Urine
Protein binding: 80-90%
","Adult: Wash hands, apply ½ inch of gel on to the sore area. This can be repeated after every 3 hours.
",,"Salicylates may enhance the effect of anticoagulants and inhibit the action of uricosurics.
","Not to be used in:
+
+- If allergic to salicylates, e.g. Aspirin
+- If have an active peptic ulcer
+
","Salicylates may produce bronchospasm and induce asthma attacks in susceptible patients.
","There is clinical evidence of the safety of salicylates in pregnancy. This medicine may pass into breast milk in very small amounts but is unlikely to have any adverse effects on a nursing infant.
","Do not exceed the recommended dose.
",,,,,"Store in a cool and dry place, away from light. Keep out of the reach of children.
",10
+1640,Ceritinib,ceritinib-1640,https://medex.com.bd/attachments/VAaC8xcmvK0gstsRX97QIQh2B6o02p/ceritinib-prescribing-information,,,"Ceritinib is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
",,"Ceritinib is a kinase inhibitor. Targets of Ceritinib inhibition identified in either biochemical or cellular assays at clinically relevant concentrations include ALK, insulin- like growth factor 1 receptor (IGF-1R), insulin receptor (InsR), and ROS1. Among these, Ceritinib is most active against ALK. Ceritinib inhibited autophosphorylation of ALK, ALK-mediated phosphorylation of the downstream signaling protein STAT3, and proliferation of ALK dependent cancer cells in in vitro and in vivo assays.
Absorption: After a single oral administration of Ceritinib in patients, peak plasma levels (Cmax) of Ceritinib were achieved at approximately 4 to 6 hours, and AUC and C max increased dose proportionally over 50 to 750 mg under fasted conditions. The absolute bioavailability of Ceritinib has not been determined.
Distribution: Ceritinib is 97% bound to human plasma proteins, independent of drug concentration. The apparent volume of distribution is 4230 L following a single 750 mg fasted Ceritinib dose in patients. Ceritinib also has a slight preferential distribution to red blood cells, relative to plasma, with a mean in vitro blood-to-plasma ratio of 1.35.
Elimination: Following a single 750 mg fasted Ceritinib dose, the geometric mean apparent plasma terminal half life (t½) of Ceritinib was 41 hours in patients. Ceritinib demonstrates nonlinear PK over time. The geometric mean apparent clearance of Ceritinib was lower at steady-state (33.2 L/h) after 750 mg daily dosing than after a single 750 mg dose (88.5 L/h).
Metabolism: In vitro studies demonstrated that CYP3A was the major enzyme involved in the metabolic clearance of Ceritinib. Following oral administration of a single 750 mg radiolabeled Ceritinib dose under fasted conditions, Ceritinib as the parent compound was the main circulating component (82%) in human plasma.
Excretion: Following oral administration of a single 750 mg radiolabeled Ceritinib dose under fasted conditions, 92.3% of the administered dose was recovered in the feces (with 68% as unchanged parent compound) while 1.3% of the administered dose was recovered in the urine.
","Patients should be selected for treatment of metastatic NSCLC with Ceritinib based on the presence of ALK positivity in tumor specimens. The recommended dose of Ceritinib is 450 mg orally once daily with food until disease progression or unacceptable toxicity. If a dose of Ceritinib is missed, that dose should be made up unless the next dose is due within 12 hours. If vomiting occurs during the course of treatment, an additional dose should not be administered and the next scheduled dose of Ceritinib should be continued. Or, as directed by the registered physician.
",,"Effect of Other Drugs on Ceritinib: Strong CYP3A Inhibitors: A strong CYP3A4/P-gp inhibitor (ketoconazole) increased the systemic exposure of Ceritinib so it should be avoided. If concomitant use of strong CYP3A inhibitors including certain antivirals (e.g., ritonavir), macrolide antibiotics (e.g., telithromycin), antifungals (e.g., ketoconazole), and nefazodone is unavoidable, the Ceritinib dose should be reduced by approximately one third, rounded to the nearest multiple of the 150 mg dosage strength. After discontinuation of a strong CYP3A inhibitor, the Ceritinib dose should be resumed that was taken prior to initiating the strong CYP3A inhibitor. Grapefruit and grapefruit juice should not be consumed as they may inhibit CYP3A.
Strong CYP3A Inducers: A strong CYP3A4/P-gp inducer (Rifampin) decreased the systemic exposure of Ceritinib. Concurrent use of strong CYP3A inducers (e.g., Carbamazepine, Phenytoin, Rifampin, and St. John's Wort) should be avoided during treatment with Ceritinib.
Effect of Ceritinib on Other Drugs: CYP3A Substrates: Ceritinib increased the systemic exposure of a sensitive CYP3A substrate (Midazolam) so it should be avoided. If concomitant use is unavoidable, dose reduction of the sensitive CYP3A substrates should be considered. If Ceritinib is coadministered with other CYP3A substrates, it should be referred to the CYP3A substrate labeling for dosage recommendation with strong CYP3A inhibitors.
CYP2C9 Substrates: Ceritinib increased the systemic exposure of a CYP2C9 substrate (Warfarin). The frequency of INR monitoring should be increased if coadministration with warfarin is unavoidable as the anti-coagulant effect of Warfarin may be enhanced. Coadministration of Ceritinib should be avoided with CYP2C9 substrates for which minimal concentration changes may lead to serious toxicities. If concomitant use of such CYP2C9 substrates is unavoidable, dose reduction should be considered for the coadministered CYP2C9 substrates.
","It is contraindicated in patients with known hypersensitivity to Ceritinib or any other components of this product.
","
+- Gastrointestinal Adverse Reactions
+- Hepatotoxicity
+- Interstitial Lung Disease/Pneumonitis
+- QT Interval Prolongation
+- Hyperglycemia
+- Bradycardia
+- Pancreatitis
+
","Ceritinib can cause fetal harm when administered to a pregnant woman. If it is used during pregnancy or if the patient becomes pregnant while taking it, the patient should be apprised of the potential hazard to the fetus. There are no data regarding the presence of Ceritinib or its metabolites in human milk, the effects of Ceritinib on the breastfed infant, or its effects on milk production. Because of the potential for serious adverse reactions including gastrointestinal adverse reactions, hepatotoxicity, pneumonitis, bradycardia and pancreatitis, a woman should be advised not to breastfeed during treatment with Cerinib and for 2 weeks following completion of therapy.
","Gastrointestinal Adverse Reactions: Severe gastrointestinal toxicity occurred in patients treated with Ceritinib 750 mg under fasted conditions. Diarrhea, nausea, vomiting, or abdominal pain occurred in 95% of 925 patients, including severe cases (Grade 3 or 4) in 14% of patients treated with Ceritinib across clinical studies. Diarrhea, nausea, vomiting, or abdominal pain leading to dose interruptions or reductions occurred in 36% of patients and leading to treatment discontinuation occurred in 1.6% of patients. Patients should be monitored and managed using standards of care, including antidiarrheals, antiemetics, or fluid replacement, as indicated. Based on the severity of the adverse drug reaction, Ceritinib should be withheld with resumption at a reduced dose.
Hepatotoxicity: Drug-induced hepatotoxicity occurred in patients treated with Ceritinib. Elevations in alanine aminotransferase (ALT) greater than 5 times the upper limit of normal (ULN) occurred in 28% and elevations in aspartate aminotransferase (AST) greater than 5 times ULN occurred in 16% of 925 patients across clinical studies. Concurrent elevations in ALT greater than 3 times the ULN and total bilirubin greater than 2 times the ULN, with alkaline phosphatase less than 2 times the ULN occurred in 0.3% of patients across clinical studies. Approximately 1.0% of patients required permanent discontinuation due to hepatotoxicity. It should be monitor with liver laboratory tests including ALT, AST, and total bilirubin once a month and as clinically indicated, with more frequent testing in patients who develop transaminase elevations. Based on the severity of the adverse drug reaction, Ceritinib should be withheld with resumption at a reduced dose, or permanently discontinue Ceritinib.
Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD/pneumonitis occurred in patients treated with Ceritinib. Across clinical studies, ILD/pneumonitis was reported in 2.4% of 925 patients treated with Ceritinib. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 3 or 4 ILD/pneumonitis was reported in 1.3% of patients, with fatal events reported in 0.2% of patients. Ten patients (1.1%) discontinued Ceritinib across clinical studies due to ILD/pneumonitis. Patients should be monitored for pulmonary symptoms indicative of ILD/pneumonitis.
QT Interval Prolongation: QTc interval prolongation, which may lead to an increased risk for ventricular tachyarrhythmia (e.g., torsades de pointes) or sudden death, occurred in patients treated with Ceritinib. Across clinical studies, 6% of 919 patients with at least one post-baseline ECG assessment experienced a QTc interval increase over baseline of greater than 60 msec. Approximately 1.3% of patients taking Ceritinib 750 mg fasted were found to have a QTc greater than 500 msec. When possible, use of Ceritinib should be avoided in patients with congenital long QT syndrome. Periodic monitoring should be conducted with electrocardiograms (ECGs) and electrolytes in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, or those who are taking medications that are known to prolong the QTc interval.
Hyperglycemia: Hyperglycemia occurred in patients receiving Ceritinib. Across clinical studies, CTCAE Grade 3 or 4 hyperglycemia, based on laboratory values, occurred in 13% of 925 patients. Fasting serum glucose should be monitored prior to the start of Ceritinib treatment and periodically thereafter as clinically indicated. Based on the severity of the adverse drug reaction, Ceritinib should be withheld until hyperglycemia is adequately controlled, then resume Ceritinib at a reduced dose.
Bradycardia: Bradycardia occurred in patients receiving Ceritinib. Across clinical studies, sinus bradycardia, defined as a heart rate of less than 50 beats per minute (bpm), was noted as a new finding in 1% of 925 patients. Bradycardia was reported as an adverse drug reaction in 1% of patients. No patient required discontinuation and 0.1% required interruption with subsequent dose reduction for bradycardia. Using Ceritinib should be avoided in combination with other agents known to cause bradycardia (e.g., beta-blockers, nondihydropyridine calcium channel blockers, clonidine, and digoxin) to the extent possible. Heart rate and blood pressure should be regularly monitored. In cases of symptomatic bradycardia that is not life threatening, Ceritinib should be withheld until recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above, evaluate the use of concomitant medications, and adjust the dose of Ceritinib.
Pancreatitis: Pancreatitis occurred in patients receiving Ceritinib. Pancreatitis, including one fatality, occurred in less than 1% of patients receiving Ceritinib in clinical studies. CTCAE Grade 3 or 4 elevations of amylase occurred in 7% of patients receiving Ceritinib across clinical studies, while CTCAE Grade 3 or 4 elevations of lipase occurred in 14% of patients. Lipase and amylase should be monitored prior to the start of Ceritinib treatment and periodically thereafter as clinically indicated. Based on the severity of the laboratory abnormalities, Ceritinib should be withheld with resumption at a reduced dose.
Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animal studies, Ceritinib can cause fetal harm when administered to a pregnant woman. Pregnant women should be advised of the potential risk to a fetus. Females of reproductive potential should be advised to use effective contraception during treatment with Ceritinib and for 6 months following completion of therapy. Based on the potential for genotoxicity, males with female partners of reproductive potential should be advised to use condoms during treatment with Ceritinib and for 3 months following completion of therapy.
","Females: Ceritinib can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should be advised to use effective contraception during treatment with Ceritinib and for 6 months following completion of therapy.
Males: Based on the potential for genotoxicity, males with female partners of reproductive potential should be advised to use condoms during treatment with Ceritinib and for 3 months following completion of therapy.
Pediatric Use: The safety and effectiveness of Ceritinib in pediatric patients have not been established.
Geriatric Use: Of the 925 patients in clinical studies of Ceritinib, 18% were 65 years or older, while 5% were 75 years or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
Hepatic Impairment: For patients with severe hepatic impairment (Child-Pugh C), the dose of Ceritinib should be reduced by approximately one-third, rounded to the nearest multiple of the 150 mg dosage strength. No dose adjustment is recommended in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.
",,,,"Store below 30°C in a cool and dry place, away from sunlight. Keep out of reach of children.
",10
+231,Cephalexin,cephalexin-231,https://medex.com.bd/attachments/RAYLFHIouLeZsSzLpRaiYAstaj205v/cephalexin-prescribing-information,First generation Cephalosporins,Urinary tract infection,"Cephalexin is indicated for the treatment of the following infections when caused by susceptible organisms.
+
+- Respiratory tract infections: Acute and chronic bronchitis and infected bronchiectasis.
+- Genito-urinary tract infections: Acute and chronic nephritis, cystitis, urethritis and prostatitis, prophylaxis of recurrent urinary tract infections.
... Read more
Cephalexin is indicated for the treatment of the following infections when caused by susceptible organisms.
+
+- Respiratory tract infections: Acute and chronic bronchitis and infected bronchiectasis.
+- Genito-urinary tract infections: Acute and chronic nephritis, cystitis, urethritis and prostatitis, prophylaxis of recurrent urinary tract infections.
+- Skin and soft tissue infections: Caused by staphylococci and/or streptococci.
+- Ear, Nose and Throat infections: Otitis media, mastoiditis, sinusitis, follicular tonsillitis and pharyngitis.
+- Bone infections: Caused by staphylococci and/or P. mirabilis.
+
","First generation Cephalosporins
","Cephalexin is a semisynthetic analogue of Cephalosporin C. It kills bacteria by interfering in the synthesis of the bacterial cell wall. Peptidoglycan is a heteropolymeric structure that provides the cell wall with mechanical stability. The final stage in the synthesis of peptidoglycan involves the completion of the cross-linking and the terminal glycine residue of the Pentaglycine Bridge is linked to the fourth residue of the pentapeptide (d-alanin). The transpeptidase enzyme that performs this step is inhibited by penicillins and cephalosporins. As a result the bacterial cell wall is weakened, the cell swells and then ruptures. Cephalexin is a first generation cephalosporin that is active by mouth.
","Adult:
+
+- The usual dose is 250 mg to 500 mg every 6 hour.
+- For skin and soft tissue infections, streptococcal pharyngitis and uncomplicated cystitis, in patients over 15 years of age: 500 mg of the drug may be administered every 12 hour.
+- In severe or deep seated infections the dose can be increased up to 3 g to 6 g daily.
+
+
Children: The dosage range is 25-100 mg/kg/day in divided doses to a maximum of 4 g daily
Children's Weight Recommended Dose:
+
+- 10 kg (22 Ibs): 62.5 mg to 125 mg qid or 125 mg to 250 mg bid
+- 20 kg (44 Ibs): 125 mg to 250 mg qid or 250 mg to 500 mg bid
+- 40 kg (88 Ibs): 250 mg to 500 mg qid or 500 mg to 1 g bid
+
+For streptococcal pharyngitis, skin and soft tissue infections and in patients over 1 year of age the total daily dose may be divided and administered every 12 hour. In the therapy of otitis media 75-100 mg/kg/day in four divided doses may be required. In the treatment of β haemolytic streptococcal infections a therapeutic dosage of the drug should be given at least for 10 days.
",,,"Cephalen is contraindicated in patients with known hypersensitivity to the cephalosporin group of antibiotics.
","Side effects include nausea, vomiting, diarrhoea and abdominal discomfort. Symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment. Skin rash, angio oedema, rise in serum aminotransferases, eosinophilia, neutropenia have been reported very rarely. Superinfection with resistant micro organisms, particularly candida may follow the treatment.
","Pregnancy Category B. Cefalexin may be used during pregnancy when it is considered essential. Cefalexin is found in the milk of nursing mothers, hence caution should be taken when it is administered to nursing mothers.
","Cefalexin should be given with caution in patients with renal impairment. Under such condition, careful clinical observation should be made because safe dosage may be lower than the usually recommended. The urine of patients receiving Cefalexin may give a false positive reaction for glucose with copper reduction reagent. Positive results to Coombs’ test have been reported. Although there is no evidence of teratogenicity in animal tests, Cefalexin may be used during pregnancy when it is considered essential. Cefalexin is found in the milk of nursing mothers, hence caution should be taken when it is administered to nursing mothers.
",,,,,"Should be stored in cool and dry place.
",9
+232,Cephradine,cephradine-232,,First generation Cephalosporins,Urinary tract infection,"Cephradine is indicated for the treatment of infections caused by sensitive Gram-positive and Gram-negative bacteria. These include-
+
+- Undesirable Upper respiratory tract infections: sinusitis, pharyngitis, tonsillitis, laryngo-tracheo bronchitis and otitis media, and also
... Read more
Cephradine is indicated for the treatment of infections caused by sensitive Gram-positive and Gram-negative bacteria. These include-
+
+- Undesirable Upper respiratory tract infections: sinusitis, pharyngitis, tonsillitis, laryngo-tracheo bronchitis and otitis media, and also
+- Lower respiratory tract infections: bronchitis (acute and chronic), lobar pneumonia and bronchopneumonia.
+- Urinary tract infections: cystitis, urethritis and pyelonephritis.
+- Skin and soft tissue infections: abscess, cellulitis, furunculosis and impetigo.
+
+The following microorganisms are susceptible, in vitro to Cephradine:
+
+- Gram-positive: Staphylococci (both penicillin sensitive and resistant strains and penicillinase-producing species), Streptococci, Streptococci pyogenes (beta haemolytic), Streptococcus pneumonia.
+- Gram-negative: Escherichia coli, Klebsiella spp, Proteus mirabilis, Haemophilus influenza, Shigella spp, Salmonella spp (including Salmonella typhi), Neisseria spp Many strains of E.coli and Staphylococcus aureus that produce the enzyme penicillinase and thus are ampicillin resistant, are susceptible to Cephradine which is unaffected by this enzyme.
+
","First generation Cephalosporins
","Cephradine is a semisynthetic broad spectrum bactericidal antibiotic, it is active against infections caused by both gram-positive and gram-negative microorganisms. Both penicillinase producing and nonproducing staphylococci are sensitive to Cephradine. The main site of action of Cephradine is the cell wall of bacteria. Cell wall of sensitive organism contains peptidoglycan. Cephradine inhibits cross-linking process and as a result cell wall with many pores are formed, thus lysis of bacteria occur due to external osmotic pressure.
","For oral administration-
Adults:
+
+- Urinary tract infections: 500mg four times daily or 1g twice daily. Infections which are severe or chronic may necessitate the administration of higher doses. Where complications arise including prostatitis and epididymitis continued intensive treatment is required.
+- Respiratory tract infections: 250 to 500mg four times daily or 500mg to 1g twice daily, dependent on the site and severity of the infection.
+- Skin and soft tissue infections: 250 to 500mg four times daily or 500mg to 1g twice daily, again dependent on the site and severity of the infection.
+
+Children:
+
+- Total daily dose of 25 to 50mg/kg given in two or four equally divided doses.
+- Otitis media: Total daily dose of 75 to 100mg/kg given in divided doses 6 to 12 hourly.
+- Maximum daily dosage: 4 gm
+
+Elderly: The normal adult dose is appropriate. Patients with impaired renal or hepatic function should be monitored during treatment.
For injectable administration-
+
+- Adult: The usual dose is 2-4 gm daily in four equally divided doses up to 8 gm daily. For prophylaxis a single preoperative dose of 1-2 gm intramuscularly or intravenously is given.
+- Children: The dose is 50-100 mg/kg daily in four equally divided doses, up to 300 mg/kg daily in severe infection.
+
",,"The concomitant use of nephrotoxic drugs such as aminoglycosides with Cefradine may increase the risk of kidney damage. Diuretics (e.g. frusemide, ethacrynic acid) and probenecid enhanced the possibility of renal toxicity.
","Cephradine should not be used in patients with known or suspected hypersensitivity to cephalosporins.
","Limited essentially to gastro-intestinal disturbances and on occasions to hypersensitivity phenomena. The latter are more likely to occur in individuals, who have previously demonstrated hypersensitivity and thos with a history of allergy, asthma, hay fever or urticaria. Skin reactions have occasionally been reported. Rare- Glossitis, heartburn, dizziness, tightness in the chest, nausea, vomiting, diarrhoea, abdominal pain, vaginitis, candida overgrowth. Skin and hypersensitivity reactions include urticaria, skin rashes, joint pains, oedema.
+
+- Blood and lymphatic system disorders- Unknown: blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia)
+- Immune system disorders- Unknown: Fever, serum sickness like reactions, anaphylaxis
+- Psychiatric disorders- Unknown: Confusion, sleep disturbances
+- Nervous system disorders- Unknown: hyperactivity, hypertonia, dizziness, nervousness; Rarely: Headache
+- Hepatobiliary disorders- Frequency unknown: Liver, enzyme disturbances, transient hepatitis, cholestatic jaundice
+- Renal and urinary disorders- Unknown: Reversible interstitial nephritis
+- Investigations- Unknown: Elevation of blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase.
+
","Although animal studies have not demonstrated any teratogenicity, safety in pregnancy has not been established. Cephradine is excreted in breast milk and should be used with caution in lactating mothers. Since the medicine may cause dizziness, patients should be cautioned about operating hazardous machinery, including automobiles.
","
+- Prolonged use of an anti-infective may result in the development of superinfection due to the emergence of resistant organisms.
+- Cephradine should be administered with care to patients hypersensitive to penicillins because of the risk of cross-sensitivity between beta-lactam antibiotics.
+- Cephalosporin antibiotics may cause a positive result in Coombs’ testing. When Coombs testing is performed on neonates whose mothers received cephalosporins prior to labour, it should be noted that a positive result may be due to the drug.
+- Cephradine may cause a false positive urine glucose result when Benedict’s or Fehling’s solutions or tablets such as Clinitest are used in the testing. This does not occur with enzyme-based tests (e.g. Clinistix, Diastix).
+- Dosage adjustment is necessary in renal impairment.
+- This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
+
","Renal Impairment: The following doses are recommended (based on 500 mg every 6 hours) for patients not on haemodialysis:
+
+- CrCl: >20 ml/min: 500 mg every 6 hours
+- CrCl: 5-20 ml/min: 250 mg every 6 hours
+- CrCl: <5 ml/min: 250 mg every 50-70 hours.
+
+Recommendations for patients on chronic, intermittent haemodialysis:
+
+- 250 mg at the start of haemodialysis
+- 250 mg 6 to 12 hours after the start
+- 250 mg 36 to 48 hours after the start
+- 250 mg at the start of the next haemodialysis session if more than 30 hours have elapsed since the last dose.
+
+Additional Information for all patients Regardless of patient age or weight, higher doses of up to 1 gm four times daily may be required for infections which are chronic or severe. Treatment should continue for at least 2 to 3 days after symptoms have resolved or bacteria have been eradicated. To reduce the possibility of rheumatic fever or glomerulonephritis resulting from infections with haemolytic streptococci, treatment should be continued for at least 10 days. Throughout treatment of chronic urinary tract infections and for several months thereafter, regular bacteriological and clinical monitoring is required.
Doses below those recommended above should not be prescribed. Paediatric dosages should not exceed those specified for adults, regardless of severity of infection. It may be necessary to continue Cephradine therapy for several weeks in persistent infections. Patients may be transferred from intramuscular/intravenous Cephradine therapy to oral treatment at the same dosage level.
","The symptoms of Sefrad overdose are non-specific and are generally nausea, vomiting, diarrhoea and gastric upsets. Treatment is mainly supportive although gastric lavage will be necessary if a large amount has been ingested.
",,,"Cephradine Suspension should be freshly prepared. Reconstituted Suspension should be used within 7 days if kept at room temperature or within 14 days, if kept in a refrigerator. Cephradine Injection solutions should be used within 2 hours when kept at room temperature. When stored at 5°C, solutions retain potency for 12 hours. Reconstituted solutions may vary in colour from light to straw yellow; however, this does not affect the potency. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician
",12
+1801,Celiprolol Hydrochloride,celiprolol-hydrochloride-1801,https://medex.com.bd/attachments/A3EEOZcISlqrLgMhyAad6cdDS2F3qR/celiprolol-hydrochloride-prescribing-information,Beta-blockers,Lower the blood pressure,"Celiprolol Hydrochloride belongs to a group of medicines called beta-blockers. It works by slowing your heart rate or lowering your blood pressure. It is used to treat high blood pressure (hypertension).
","Beta-blockers
","Celiprolol is a vasoactive beta-1 selective adrenoceptor antagonist with partial beta-2 agonist activity. The beta-2 agonist activity is thought to account for its mild vasodilating properties. It lowers blood pressure in hypertensive patients at rest and on exercise. The effects on heart rate and cardiac output are dependent on the pre-existing background level of sympathetic tone. Under conditions of stress such as exercise, celiprolol attenuates chronotropic and inotropic responses to sympathetic stimulation. However, at rest minimal impairment of cardiac function is seen.
","Adults including the elderly: the recommended starting dose is 200 mg of Celiprolol Hydrochloride once a day. If needed after 2 to 4 weeks, your doctor will increase your dose to 400 mg once a day. The maximum dose is 400 mg once a day. If you have the impression that the effect of Celiprolol Hydrochloride tablets is too strong or too weak, talk to your doctor or pharmacist.
Adults with liver or kidney problems: if you have kidney problems, your doctor may give you a lower dose than stated above and increase it as needed. A reduction in dosage by half may be appropriate in patients with moderate impairment of kidney function (creatinine clearance in the range of 15-40 ml per minute). Celiprolol Hydrochloride is not recommended for patients with severely impaired kidney function (creatinine clearance less than 15 ml per minute). Use of low doses of Celiprolol Hydrochloride is recommended in patients with liver problems.
","Always take this medicine exactly as your doctor has told you. Swallow the tablets whole with a glass of water. Take the tablets preferably first thing in the morning, one hour before food or two hours after food. To help you remember to take your medicine, try to get into the habit of taking it at the same time each day, preferably first thing in the morning.
",,"Do not take Celiprolol Hydrochloride if you:
+
+- are allergic to celiprolol hydrochloride or any of the ingredients of this medicine. Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
+- have suffered an allergic reaction to a beta-blocker (propranolol, sotalol, timolol etc.) in the past
+- suffer from an irregular/very slow heartbeat (known as bradycardia) or low blood pressure (hypotension)
+- suffer from heart failure which is not under control (heart failure is a condition in which your heart is not pumping blood as well as it should), have an abnormal heart rhythm, difficulty breathing and swollen ankles
+- suffer from missed heart beats (heart block) or other heart problems or you suffer from hardened arteries
+- have severe kidney problems
+- have, or have had, episodes of asthma, wheezing or other severe breathing problems
+- have a rare tumour called a phaeochromocytoma that is not being treated
+- have abnormal levels of acid in your blood (metabolic acidosis), usually as a result of severe illness
+- are already taking theophylline (an anti-asthma medicine).
+- have late stage peripheral arterial occlusive disease or Raynaud’s syndrome.
+
","Serious side effects: Allergic reaction: a rash, swallowing or breathing problems, swelling of your face, lips, throat or tongue. You get flu like symptoms, swollen or painful joints, increased sensitivity to sunlight, hair loss, abdominal pain, anaemia. This may mean you have a condition called Systemic Lupus Erythematosus (SLE). These symptoms will usually go away after Celiprolol Hydrochloride has been stopped. These are very serious side effects. If you have them you may have had a serious allergic reaction to Celiprolol Hydrochloride. You may need urgent medical attention or hospitalization.
Common side effects (may affect up to 1 in 10 people): Dizziness or light headedness, weakness, or fainting especially when standing up from a lying position. These could be signs of low blood pressure. Skin rashes, excessive itching
","If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advise before taking this medicine. If your doctor cannot find any safer alternative you may be given Celiprolol Hydrochloride. If you take Celiprolol Hydrochloride during pregnancy, you should tell your midwife. In the new born of the treated mother, activity of these kind of medicines remains for several days. The effects can include slow heart beat, heart failure or having trouble breathing. Therefore close monitoring of the neonate is recommended for the first 3 to 5 days of life. If you are already taking Celiprolol Hydrochloride and have just found out you are pregnant, you should talk to your doctor immediately. You should not breast-feed if you are taking Celiprolol Hydrochloride. If you are breast-feeding or planning to breast-feed you should talk to your doctor or pharmacist before taking this medicine.
","Take special care and consult your doctor before taking Celiprolol Hydrochloride if you:
+
+- have liver or kidney problems
+- have Prinzmetal’s angina (chest pain while resting)
+- have poor blood circulation e.g. Raynaud’s, Burger’s Disease. Symptoms of Raynaud’s disease include fingers and toes changing colour when cold and tingling or painful on warming up. Your doctor will closely monitor you while taking this medicine.
+- have inadequate circulation of blood through the coronary arteries.
+- have ever had a skin condition known as psoriasis. Your doctor will stop this medicine if you have.
+- have asthma or breathing problems due to long term lung problems (called bronchitis or emphysema)
+- have a thyroid problem as the effects of an overactive thyroid gland (thyrotoxicosis) may be hidden by beta blocker medicine
+- have a history of severe allergies, particularly to other medicines, including anaphylactic reactions
+- need anti-allergic treatment eg. following a wasp or bee sting; your doctor may wish to interupt your Celiprolol Hydrochloride treatment to prevent a possible allergic reaction.
+- are diabetic. Patients with diabetes should be aware that the symptoms of low blood pressure (hypoglycaemia) may be hidden by beta blocker medicines
+- have any heart failure that is under control with medication. Your doctor will give this medicine under strict medical surveillance
+- have a slow or irregular heartbeat.
+
","Use in children: Celiprolol Hydrochloride is not recommended for use in children.
Use in elderly: Your doctor may decide to lower your dose of Celiprolol Hydrochloride if necessary.
","You may have symptoms such as slow heart beats, low blood pressure, feeling dizzy or weak, difficulty in breathing, wheezing or heart problems. Contact your doctor or go to the nearest hospital causalty department immediately. Take this leaflet or some tablets with you so your doctor will know what you have taken.
",,,"Keep container in the outer carton. Do not store above 25°C. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
",12
+228,Celecoxib,celecoxib-228,https://medex.com.bd/attachments/7GKNvYzqktkFrnTclLZMjSTW02pdO9/celecoxib-prescribing-information,Drugs for Osteoarthritis,Spondylitis,"Celecoxib is indicated-
+
+- For the relief of the signs and symptoms of osteoarthritis.
+- For the relief of the signs and symptoms of rheumatoid arthritis.
+- For the regression and prevention of colorectal adenomatous polyps in patients with familial adenomatous polyposis (FAP).
+
","Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Celecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor, non-steroidal anti-inflammatory drug (NSAID). It exhibits anti-inflammatory, analgesic and antipyretic properties. The mechanism of action of Celecoxib is believed to be due to the inhibition of prostaglandin synthesis, via the inhibition of cyclooxygenase-2 (COX-2) enzyme. At therapeutic concentration, Celecoxib does not inhibit cyclooxygenase-1 (COX-1) isoenzyme.
","Osteoarthritis: The recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily.
Rheumatoid arthritis: The recommended oral dose is 100 to 200 mg twice daily.
Familial adenomatous polyposis (FAP): Usual medical care for FAP patients should be continued while on Celecoxib. To reduce the number of adenomatous colorectal polyps in patients with FAP, the recommended oral dose is 400 mg (2x200 mg capsules) twice daily to be taken with food.
",,"ACE inhibitors: Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given into consideration in patients taking Celecoxib concomitantly with ACE inhibitors.
Frusemide: NSAIDs can reduce the natriuretic effect of Frusemide and thiazides in some patients.
Aspirin: Celecoxib can be used with low dose Aspirin. However, concomitant administration of Aspirin with Celecoxib may result in an increased rate of gastrointestinal ulceration or similar complications, compared to the use of Celecoxib alone.
Fluconazole: Concomitant administration of Fluconazole at 200 mg qid resulted in a two fold increase in Celecoxib plasma concentration. Celecoxib should be introduced at the lowest recommended dose in patients receiving Fluconazole.
Lithium: Patients on Lithium treatment should be closely monitored when Celecoxib is introduced or withdrawn.
Warfarin: Caution should be used when administering Celecoxib with Warfarin since these patients are at increased risk of bleeding complications.
Co-administration of Celecoxib with aluminium and magnesium-containing antacid should be avoided, because they may reduce the amount of Celecoxib that the body absorbs.
","Celecoxib is contraindicated in patients with known hypersensitivity to Celecoxib. It should not be given to patients who have demonstrated allergic type reactions to Sulphonamides (Celecoxib contains a sulphonamide side chain). Celecoxib should not be given to patients who have demonstrated asthma, urticaria or allergic type reactions after taking Aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic like reactions to NSAIDs have been reported in such patients.
","Adverse events occurring in ≥2% of patients at recommended doses - Abdominal pain 4.1%, diarrhoea 5.6%, dyspepsia 8.8%, flatulence 2.2%, nausea 3.5%, back pain 2.8%, peripheral oedema 2.1%, accidental injury 2.9%, dizziness 2.0%, headache 15.8%, insomnia 2.3%, pharyngitis 2.3%, rhinitis 2.0%, sinusitis 5.0%, upper respiratory tract infections 8.1%, rash 2.2%. The following adverse events occurred in 0.1-1.9% of patients-
+
+- General: Allergy aggravated, allergic reaction, asthenia, chest pain, oedema generalised, face oedema, fatigue, fever, hot flushes, influenza like symptoms, pain, peripheral pain.
+- Gastrointestinal: Constipation, diverticulitis, dysphagia, oesophagitis, gastritis, gastroenteritis, gastro-oesophageal reflux disease, haemorrhoids, hiatal hernia, melaena, dry mouth, stomatitis, tenesmus, tooth disorder, vomiting.
+- Cardiovascular: Aggravated hypertension, angina pectoris, coronary artery disease, myocardial infarction.
+- Nervous system: Leg cramps, hypertonia, hypoesthesia, migraine, neuralgia, neuropathy, paresthesia, vertigo. Female reproductive system : Breast fibroadenosis, breast neoplasm, breast pain, dysmenorrhoea, menstrual disorder, menorrhagia, vaginitis.
+- Male reproductive system: Prostatic disorder.
+- Resistance mechanism disorders: Herpes simplex, herpes zoster, bacterial infection, fungal infection, infection of soft tissue, viral infection, moniliasis, moniliasis genital, otitis media.
+- Hearing and vestibular: Deafness, ear abnormality, earache, tinnitus.
+- Heart rate and rhythm: Palpitation, tachycardia.
+- Respiratory: Bronchitis, bronchospasm, bronchospasm aggravated, coughing, dyspnoea, laryngitis, pneumonia.
+- Liver and biliary system: Peptic function abnormal, increased AST and ALT.
+- Musculoskeletal: Arthralgia, arthrosis, accidental fracture, myalgia, neck stiffness, synovitis, tendinitis.
+- Urinary system: Albuminuria, cystitis, dysuria, haematuria, micturition frequency, renal calculus, urinary incontinence, urinary tract infection.
+- Metabolic and nutritional: Blood urea nitrogen (BUN), CPK, creatinine, alkaline phosphatase, are increased. Hypercholesterolaemia, hyperglycaemia, hypokalaemia. Bodyweight is also increased.
+- Psychiatric: Anorexia, anxiety, increased appetite, depression, nervousness, somnolence.
+- Haemic: Anaemia, ecchymosis, epistaxis, thrombocythaemia.
+- Skin and appendages: Alopecia, dermatitis, photosensitivity reaction, pruritus, rash erythematous, rash maculopapular, skin disorder, dry skin, increased sweating, urticaria.
+- Application site disorders: Cellulitis, contact dermatitis, skin nodule.
+- Special senses: Taste perversion.
+- Vision: Blurred vision, cataract, conjunctivitis, eye pain, glaucoma.
+
","Celecoxib should be used during pregnancy only if the potential benefit justifies the potential risk to fetus. But in late pregnancy Celecoxib should be avoided because it may cause premature closure of ductus arteriosus. It is not known whether Celecoxib is excreted in human milk. Because many drugs are excreted in human milk and because of potential for serious adverse reactions in nursing infants from Celecoxib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","Celecoxib, at doses up to 200 mg bid, can be administered without regard to timing of meal. Higher doses (400 mg bid) should be administered with food.
","Geriatric: Dose adjustment in the elderly is not generally necessary. However, for patients of less than 50 kg in body weight, initiate therapy at the lowest recommended dose.
Paediatric: The safety and efficacy of Celecoxib is not established in pediatric patients.
Hepatic insufficiency: Celecoxib capsules should be introduced at a reduced dose in patients with moderate hepatic impairment. The use of Celecoxib in patients with severe hepatic impairment is not recommended.
","Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. No information is available regarding the removal of Celecoxib by hemodialysis but based on its high degree of plasma protein binding (>97%) dialysis is unlikely to be useful in overdose. Emesis and/or activated charcoal and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine, hemodialysis or hemoperfusion may not be useful due to high protein binding.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+227,Cefuroxime Axetil + Clavulanic Acid,cefuroxime-axetil-clavulanic-acid-227,,Second generation Cephalosporins,Urinary tract infection,"It is indicated for the treatment of infections caused by sensitive bacteria.
+
+- Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
+- Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
... Read more
It is indicated for the treatment of infections caused by sensitive bacteria.
+
+- Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
+- Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
+- Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
+- Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, E. coli.
+- Acute bacterial exacerbation of chronic bronchitis and secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
+- Uncomplicated skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
+- Uncomplicated urinary tract infections caused by E.coli or Klebsiella pneumoniae.
+- Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
+- Uncomplicated Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
+- Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
+- Septicemia caused by Staphylococcus aureus, Streptococcus pneumoniae, E.coli, Haemophilus influenzae (including ampicillin-resistant strains) & Klebsiella spp.
+- Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis & Staphylococcus aureus (penicillinase and non-penicillinase producing strains)
+- Switch therapy (Injectable to oral)
+
","Second generation Cephalosporins
","Cefuroxime is a bactericidal second generation cephalosporin antibiotic which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. Cefuroxime inhibits bacterial cell wall synthesis by interfering with the transpeptidation process.
Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.
","Adolescents and adults (13 years and older)-
+
+- Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
+- Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
+- Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
+- Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
+- Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
+- Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
+- Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose
+- Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
+- MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
+- Early Lyme disease: 500 mg b.i.d. for 20 days
+
+Paediatric Patients (3 months to 12 years)-
+
+- Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
+- Acute otitis media: 30 mg/kg/day b.i.d for 10 days
+- Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
+- Impetigo: 30 mg/kg/day b.i.d for 10 days
+
","Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.
","Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.
","Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.
","Generally Cefuroxime-Clavulanic Acid is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.
","While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.
","Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.
",,,,,"Store in a cool, dry place (below 30o C), away from light and moisture. Keep out of the reach of children.
",11
+226,Cefuroxime Axetil,cefuroxime-axetil-226,https://medex.com.bd/attachments/zKfe0N6w8JTmbxHc5IKSAWttF3wNVB/cefuroxime-axetil-tablets-oral-suspension-prescribing-information,Second generation Cephalosporins,Urinary tract infection,"It is indicated for the treatment of infections caused by sensitive bacteria.
+
+- Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
+- Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
... Read more
It is indicated for the treatment of infections caused by sensitive bacteria.
+
+- Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
+- Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
+- Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
+- Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, E. coli
+- Acute bacterial exacerbation of chronic bronchitis and Secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
+- Skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
+- Urinary tract infections caused by E.coli or Klebsiella pneumoniae.
+- Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
+- Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
+- Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
+
","Second generation Cephalosporins
","Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.
","Tablet or Suspension-
+Adolescents and adults (13 years and older)-
+
+- Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
+- Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
+- Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
+- Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
+- Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
+- Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
+- Uncomplicated Gonorrhoea: 1000 mg Single dose
+- Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
+- MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
+- Early Lyme disease: 500 mg b.i.d. for 20 days
+
+Paediatric Patients (3 months to 12 years)-
+
+- Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
+- Acute otitis media: 30 mg/kg/day b.i.d for 10 days
+- Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
+- Impetigo: 30 mg/kg/day b.i.d for 10 days
+
+
+
Parenteral-
+
+- Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
+- Children (above 3 months of age): 30 - 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
+- Neonate: 30 - 100 mg/kg/day given in 2 or 3 equally divided doses.
+- Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
+- Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.
+
Acute exacerbations of chronic bronchitis: 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)
+- In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).
+
+In Meningitis:
+
+- Adult: 3 gm IV injection three times daily.
+- Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
+- Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.
+
+In bone and joint infections:
+
+- Adult: 1.5 gm IV injection four times daily.
+- Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.
+
","The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5o C
","No potentially hazardous interactions have been reported.
","Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.
","Adverse effects to Cefuroxime have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.
","US FDA pregnancy category of Cefuroxime is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.
","Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis. Cephalosporin antibiotics may in general be given safely to patients who are hypersensitive to penicillin although cross reactions have reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.
",,,,"For 750 mg intramuscular injection: Add 3 ml water for injection to vial and then shake gently for dispersion.
For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.
For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.
","Store in a cool, dry place (below 30o C), away from light & moisture. Keep out of the reach of children.
",12
+225,Ceftriaxone Sodium,ceftriaxone-sodium-225,https://medex.com.bd/attachments/nl4wG1qceRM6xSq6qrfMkCkrX3vrym/ceftriaxone-sodium-prescribing-information,Third generation Cephalosporins,Urinary tract infection,"Ceftriaxone is indicated for the treatment of the following major infections:
+
+- Lower respiratory tract infections
+- Acute Bacterial Otitis Media
+- Skin and skin structure infections
+- Urinary tract infections
+- Gonorrhea
+- Bacterial Septicemia
+- Bone and joint infections
... Read more
Ceftriaxone is indicated for the treatment of the following major infections:
+
+- Lower respiratory tract infections
+- Acute Bacterial Otitis Media
+- Skin and skin structure infections
+- Urinary tract infections
+- Gonorrhea
+- Bacterial Septicemia
+- Bone and joint infections
+- Meningitis
+- Prevention of postoperative infections
+- Perioperative prophylaxis of infections associated with surgery
+
","Third generation Cephalosporins
","Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).
","Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
+
+- Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
+- Uncomplicated gonococcal infections: 250 mg IM as a single dose
+- Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery
+
+
Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
+
+- Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
+- Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
+- Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day
+
+
Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.
","Preparation of Solutions for Intramuscular / Intravenous Injections:
+
+- For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
+- For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.
+
+The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).
","No drug interactions have been reported.
","Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.
","Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.
","Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.
","As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.
","Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).
","There is no specific antidote. Treatment of overdosage should be symptomatic.
",,,"Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.
",13
+224,Ceftibuten Dihydrate,ceftibuten-dihydrate-224,https://medex.com.bd/attachments/axRiTVJ7E8V1ht9Dlag3ohUrSXUJQ9/ceftibuten-dihydrate-prescribing-information,Third generation Cephalosporins,Urinary tract infection,"Ceftibuten is indicated for the treatment of individuals with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.
+
+- Acute Bacterial Exacerbations of Chronic Bronchitis: Due to Haemophilus influenzae (including β-lactamase producing strains), Moraxella catarrhalis (including (β-lactamase producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only).
... Read more
Ceftibuten is indicated for the treatment of individuals with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.
+
+- Acute Bacterial Exacerbations of Chronic Bronchitis: Due to Haemophilus influenzae (including β-lactamase producing strains), Moraxella catarrhalis (including (β-lactamase producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only).
+- Acute Bacterial Otitis Media: Due to Haemophilus influenzae (including β-lactamase producing strains), Moraxella catarrhalis (including β-lactamase producing strains) or Streptococcus pyogenes.
+- Pharyngitis and Tonsillitis: Due to Streptococcus pyogenes.
+
","Third generation Cephalosporins
","Ceftibuten is the dihydrate salt of Ceftibuten, is a semi-synthetic Cephalosporin antibiotic for oral administration. Ceftibuten exerts its bactericidal action by binding to essential target proteins of the bacterial cell wall. This binding leads to inhibition of cell-wall synthesis.
","Otitis Media-
+
+- Adult Dosage: 400 mg orally every 24 hours for 10 days
+- Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days
+
+Tonsillitis/Pharyngitis-
+
+- Adult Dosage: 400 mg orally every 24 hours for 10 days
+- Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days
+
+Bronchitis-
+
+- Adult Dosage: 400 mg orally every 24 hours for 10 days
+- Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 days
+
+Cystitis-
+
+- Adult Dosage: 400 mg orally every 24 hours for 7 days
+- Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 7 days
+
+Pneumonia-
+
+- Adult Dosage: 200 mg orally every 12 hours for 7 to 14 days
+- Pediatric Dosage: >12 years: 200 mg orally every 12 hours for 7 to 14 days
+
+Sinusitis-
+
+- Adult Dosage: 400 mg orally every 24 hours for 10 to 14 days
+- Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 to 14 days
+
+Urinary tract Infection-
+
+- Adult Dosage: 400 mg orally every 24 hours for 10 days
+- Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days
+
",,"Theophylline & Antacid do not alter the pharmacokinetic profile of Ceftibuten. Ranitidine increases the Cmax & AUC of Ceftibuten.
","Ceftibuten is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
","Nausea, headache, diarrhea, dyspepsia, dizziness, abdominal pain, vomiting.
","Pregnancy Category B. There are no controlled data on the use of Ceftibuten in pregnant women. Ceftibuten should be used in pregnancy only when the benefit clearly outweighs the risk. It is not known whether Ceftibuten (recommended dosage) is excreted in human milk. Because many drugs are excreted in human milk, caution should be excercised when Ceftibuten is administered to nursing women.
","As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. The dose of Ceftibuten may require adjustment in patients with varying degrees of renal insufficiency. Ceftibuten should be prescribed with caution to individuals with a history of gastrointestinal disease, particularly colitis.
","Renal Impairment-
+
+- CrCl 5 to 29 ml/min: 2.25 mg/kg or 100 mg orally once a day
+- CrCl 30 to 49 ml/min: 4.5 mg/kg or 200 mg orally once a day
+
+Hepatic Impairment: Dose adjustment is not necessary.
",,,"
+- The small bottle contains purified water and large bottle contains granules
+- Pour the purified water completely into large bottle
+- Tighten the cap of large bottle and shake the bottle for at least one minute
+- Use a measuring cup or dropper for reconstituted suspension
+
+Prepared suspension to be consumed within 14 days of preparation if kept in a refrigerator. Shake the bottle well each time before use.
","Store below 25°C, protected from light and moisture. For Suspension: After reconstitution, the suspension may be used for 14 days while stored at 2° to 8°C. Keep out of reach of children.
",12
+223,Ceftazidime Pentahydrate,ceftazidime-pentahydrate-223,https://medex.com.bd/attachments/9sS1qgTdFZdc4MkWucNYUyaiuuSDxC/ceftazidime-pentahydrate-prescribing-information,Third generation Cephalosporins,Urinary tract infection,"Ceftazidime Injection is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases:
Lower Respiratory Tract Infections, including pneumonia, caused by Pseudomonas aeruginosa and other Pseudomonas ... Read more
Ceftazidime Injection is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases:
Lower Respiratory Tract Infections, including pneumonia, caused by Pseudomonas aeruginosa and other Pseudomonas spp., Haemophilus influenzae, including ampicillin-resistant strains; Klebsiella spp.; Enterobacter spp.; Proteus mirabilis; Escherichia coli; Serratia spp.; Citrobacter spp.; Streptococcus pneumoniae; and Staphylococcus aureus (methicillin susceptible strains).
Skin and Skin Structure Infections caused by Pseudomonas aeruginosa; Klebsiella spp.; Escherichia coli; Proteus spp., including Proteus mirabilis and indole-positive Proteus, Enterobacter spp.; Serratia spp.; Staphylococcus aureus (methicillin susceptible strains); and Streptococcus pyogenes (group A beta-hemolytic streptococci).
Urinary Tract Infections, both complicated and uncomplicated, caused by Pseudomonas aeruginosa; Enterobacter spp.; Proteus spp., including Proteus mirabilis and indole-positive Proteus, Klebsiella spp.; and Escherichia coli.
Bacterial Septicemia caused by Pseudomonas aeruginosa, Klebsiella spp., Haemophilus influenzae, Escherichia coli, Serratia spp., Streptococcus pneumoniae and Staphylococcus aureus (methicillin susceptible strains).
Bone and Joint Infections caused by Pseudomonas aeruginosa, Klebsiella spp., Enterobacter spp., and Staphylococcus aureus (methicillin susceptible strains).
Gynecologic Infections, including endometritis, pelvic cellulitis, and other infections of the female genital tract caused by Escherichia coli.
Intraabdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella spp., and Staphylococcus aureus (methicillin susceptible strains) and polymicrobial infections caused by aerobic and anaerobic organisms and Bacteroides spp.
Central Nervous System Infections, including meningitis, caused by Haemophilus influenzae and Neisseria meningitidis, Pseudomonas aeruginosa and Streptococcus pneumoniae.
","Third generation Cephalosporins
","Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibiotic for parenteral administration. Ceftazidime is bactericidal in action exerting its effect by inhibition of enzymes responsible for cell-wall synthesis. A wide range of gram-negative organisms is susceptible to ceftazidime in vitro, including strains resistant to gentamicin and other aminoglycosides. In addition, ceftazidime has been shown to be active against gram-positive organisms. It is highly stable to most clinically important beta-lactamases, plasmid or chromosomal, which are produced by both gram-negative and gram-positive organisms and, consequently, is active against many strains resistant to ampicillin and other cephalosporins.
","The usual adult dosage is 1 gram administered intravenously or intramuscularly every 8 to 12 hours. The dosage and route should be determined by the susceptibility of the causative organisms, the severity of infection and the condition, and renal function of the patient.
Ceftazidime is to be used by the parenteral route, the dosage depending upon the severity, sensitivity & type of infections and the age, weight & renal function of the patient.
Adults: The adult dosage range for ceftazidime is 1 to 6 gm per day 8 or 12 hourly (IM/IV) in the majority of infections, 1 gm 8 hourly or 2 gm 12 hourly should be given.
+
+- In urinary tract infections and many less serious infections: 500 mg or 1 gm 12 hourly is usually adequate.
+- In severe infections, especially immunocompromised patients, including those with neutropenia: 2 gm 8 or 12 hourly should be administered. When used as a prophylactic agent in prostatic surgery 1 gm should be given at the induction of anesthesia. A second dose should be considered at the time of catheter removal.
+
+
Elderly: In view of the reduced clearance of Ceftazidime in acutely ill elderly patients, the daily dosage should not normally exceed 3 gm, especially in those over 80 years of age.
+
+- Cystic fibrosis: In fibrocystic adults with normal renal function who have pseudomonal lung infections, high doses of 100 to 150 mg/kg/day as three divided doses should be used.
+
+
Infants and Children: The usual dosage range for children aged over two months is 30 to 100 mg/kg/day, given as two or three divided doses. Doses up to 150 mg/kg/day (maximum 6 gm daily) in three divided doses may be given to infected immunocompromised or fibrocystic children or children with meningitis.
Neonates and Children up to 2 months of age: The usual dosage range is 25 to 60 mg/kg/day as two divided doses.
","Ceftazidime may be given intravenously or by deep IM injection into a large muscle mass such as the upper outer quadrant of the gluteus maximus or lateral proof of the thigh. Intra-arterial administration should be avoided. For IV/IM administration, Ceftazidime should be reconstituted with the supplied Sterile Water for Injection.
",,"Ceftazidime is contraindicated in patients who have shown hypersensitivity to Ceftazidime or the cephalosporin group of antibiotics.
","The most common side-effects are local reactions following IV injection and allergic and gastrointestinal reactions. Hypersensitivity reactions are pruritus, rash, and fever. Angioedema and anaphylaxis have been reported very rarely. Gastrointestinal symptoms are diarrhea, nausea, vomiting, and abdominal pain. Central nervous system reactions included headache, dizziness, and paresthesia.
","Pregnancy: No adequate and well-controlled studies in pregnant women have been conducted with Ceftazidime. Because animal reproduction studies are not always predictive of human response this drug should be used during pregnancy only if clearly needed.
Lactation: Ceftazidime is excreted in human milk in low concentrations. Because many drugs are excreted in human milk and because the safety of the component of the injections in nursing infants has not been established, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","The total daily dosage should be reduced when Ceftazidime is administered to patients with renal insufficiency. Ceftazidime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
","Impaired Renal Function: Ceftazidime is excreted by the kidneys, almost exclusively by glomerular filtration. Therefore, in patients with impaired renal function (glomerular filtration rate <50 mL/min), it is recommended that the dosage of ceftazidime be reduced to compensate for its slower excretion. In patients with suspected renal insufficiency, an initial loading dose of 1 gram of Ceftazidime may be given. An estimate of GFR should be made to determine the appropriate maintenance dosage.
Dosage in peritoneal dialysis: Ceftazidime may also be used in peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD). As well as using Ceftazidime intravenously, it can be incorporated into the dialysis fluid (usually 125 to 250 mg for 2L of dialysis fluid).
Impaired Hepatic Function: No adjustment in dosage is required for patients with hepatic dysfunction.
","Ceftazidime overdosage has occurred in patients with renal failure. Reactions have included seizure activity, encephalopathy, asterixis, neuromuscular excitability, and coma. Patients who receive an acute overdosage should be carefully observed and given supportive treatment.
",,"Single-dose vial Administration Amount of WFI to be added: 250 mg IM in 1.5 ml, 250 mg IV in 5 ml, 500 mg IM in 1.5 ml, 500 mg IV in 5 ml and 1 g IM in 3 ml, 1 g IV in 10 ml.
","Store below 25°C, protected from light and moisture. Reconstituted solutions are stable for up to 24 h if stored between 2°-8°C.
",13
+2029,Ceftazidime + Avibactam,ceftazidime-avibactam-2029,https://medex.com.bd/attachments/4KyRwv6wbd6I65A7zpDfgRE3z8vPs0/ceftazidime-avibactam-prescribing-information,,,"This is indicated in adults and paediatric patients aged 3 months and older for the treatment of the following infections:
+
+- Complicated intra-abdominal infection (cIAI)
+- Complicated urinary tract infection (cUTI), including pyelonephritis
+- Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP)
... Read more
This is indicated in adults and paediatric patients aged 3 months and older for the treatment of the following infections:
+
+- Complicated intra-abdominal infection (cIAI)
+- Complicated urinary tract infection (cUTI), including pyelonephritis
+- Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP)
+
+Treatment of adult patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. This is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults and paediatric patients aged 3 months and older with limited treatment options. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
",,"Ceftazidime inhibits bacterial peptidoglycan cell wall synthesis following binding to penicillin binding proteins (PBPs), which leads to bacterial cell lysis and death. Avibactam is a non β-lactam, β-lactamase inhibitor that acts by forming a covalent adduct with the enzyme that is stable to hydrolysis. It inhibits both Ambler class A and class C β-lactamases and some class D enzymes, including extended-spectrum β-lactamases (ESBLs), KPC and OXA-48 carbapenemases, and AmpC enzymes. Avibactam does not inhibit class B enzymes (metallo-β-lactamases) and is not able to inhibit many class D enzymes.
","It is recommended that this should be used to treat infections due to aerobic Gram-negative organisms in adults and paediatric patients aged 3 months and older with limited treatment options only after consultation with a physician with appropriate experience in the management of infectious diseases.
+
+- Complicated intra-abdominal infection: 2 g/0.5 g, every 8 hours for 5-14 days.
+- Complicated urinary tract infection (cUTI), including pyelonephritis: 2 g/0.5 g every 8 hours for 5-10 days.
+- Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP): 2 g/0.5 g Every 8 hours for 7-14 days.
+- Bacteraemia associated with, or suspected to be associated with any of the above infections: 2 g/0.5 g Every 8 hours. Duration of treatment should be in accordance with the site of infection.
+- Infections due to aerobic Gram-negative organisms in patients with limited treatment options: 2 g/0.5 g Every 8 hours. Guided by the severity of the infection, the pathogen(s) and the patient’s clinical and bacteriological progress.
+
",,,"Hypersensitivity to the active substances or to any of the excipients. Hypersensitivity to any cephalosporin antibacterial agent. Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other type of β-lactam antibacterial agent (e.g. penicillins, monobactams or carbapenems).
","severe allergic reactions: signs include sudden swelling of your lips, face, throat or tongue, a severe rash or other severe skin reactions, difficulty swallowing or breathing. This reaction may be life-threatening. diarrhoea that keeps getting worse or does not go away, or stools that contains blood or mucus-this may happen during or after treatment is stopped with this combination. If this happens do not take medicines that stop or slow bowel movement.
","Animal studies with ceftazidime do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Animal studies with avibactam have shown reproductive toxicity without evidence of teratogenic effects. Ceftazidime/avibactam should only be used during pregnancy if the potential benefit outweighs the possible risk. Ceftazidime is excreted in human milk in small quantities. It is unknown whether avibactam is excreted in human milk. A risk to newborns/infants cannot be excluded. A decision must be made whether to discontinue breast feeding or to discontinue/abstain from ceftazidime/avibactam therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
","This medicinal product does not require any special storage conditions. Store in the original package in order to protect from light.
","Elderly: No dosage adjustment is required in elderly patients.
Renal impairment: No dosage adjustment is required in patients with mild renal impairment.
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+1716,Almond + Coconut + Edible Pine + Salep,almond-coconut-edible-pine-salep-1716,,Herbal and Nutraceuticals,Nocturnal enuresis,"This is indicated in
+
+- Spermatorrhoea
+- Oligospermia
+- Sexual debility
+- Nocturnal emission
+
","Herbal and Nutraceuticals
","This is a unique formulation of Almond (Prunus amygdalus), Coconut (Cocos nucifera), Edible Pine (Pinus gerardiana), Salep (Orchis latifolia), Mastic tree (Pistacia lentiscus), which enhances retentive power and relieves oligospermia. It also prevents sparmatorrhoea and premature ejaculation. This preparation enhances viscosity of semen & prolongs the duration of coitus and ensures post coitus freshness.
","1-2 teaspoonful(s) twice daily with or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in the therapeutic dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1715,Acacia + Dates + Asparagus + Edible Pine,acacia-dates-asparagus-edible-pine-1715,,Herbal and Nutraceuticals,Gonorrhoea,"This is indicated in-
+
+- Sexual debility
+- Spermatorrhoea
+- Oligospermia
+- Gonorrhoea
+
","Herbal and Nutraceuticals
","This is a unique formulation of Acacia (Acacia arabica), Dates (Phoenix dactylifera), Asparagus (Asparagus racemosus), Edible Pine (Pinus gerardiana), Hazel nut (Corylus avellana), Levant cotton (Gossypium herbaceum), Clove (Eugenia caryophyllus), Nutmeg (Myristica fragrans) etc. It helps to relives sparmatorrhoea, oligospermia and sexual debility. It is an ideal aphrodisiac and nervine tonic.
","1 teaspoonful twice daily before meal for 2-3 months or as prescribed by the physician.
",,,"There is no known contraindication.
","No significant side effect has been observed in the therapeutic dosage.
",,"Keep out of reach of the children.
",,,,,"Store at cool and dry place, protect from light.
",8
+1752,Abhayarista,abhayarista-1752,,Herbal and Nutraceuticals,Piles,"This is indicated in-
+
+- Haemorrhoid
+- Bleeding piles
+- Constipation
+- Indigestion
+- Hyperacidity
+- Carminative
+
","Herbal and Nutraceuticals
","Terminalia chebula: It contains chebulinic acid, tannic acid, gallic acid, resin, tannin and glycoside. It prevents haemorrhoid, bleeding, constipation and improve digestive power.
Vitis vinifera: It contains sugar gum, tannin, tartaric, citric, racemic and malic acids, chlondes of potassium and sodium, iron, albumin etc. It is used as demulcent, diuretic, laxative, stomachic and tonic. It is also used in dyspepsia.
Madhuca indica: It contains glycoside saponin, sapogenin, B-sitosterol and sterol glucoside. It is used in haemorrhoids and constipation.
Embelia ribes: It contains hydroquinone embelin alkaloid christembine, tannin, quercifol and volatile oil that have carminative, laxative, stomachic and anthelmintic activities. It is also used to improve digestive power.
Tribulus terrestris: It contains alkaloids, pedalitin, diosmetin and dinatin. It is cooling, tonic, and carminative. It is used in piles and remove inflammation.
Piper chaba: It contains pipperin, pippalartin, pipperleguminin, sterols, glycosides etc. It cures piles, cough and indigestion.
Coriandrum sativum: It contains a-pinene, limonene, B-phellandrene, linalool, geraniol, linalys acetate etc. It has carminative, stomachic, refrigerant and antibacterial activity. It can help to remove dyspepsia.
Zingiber officinale: It contains zingiberenen, zingerfone, terpenes, cineol, borneol, citrol, camphene, phelandrene, gingerol shogaol etc. It is digestive, carminative, stomachic ano stimulant. It also use in dyspepsia, flatulent, colic and constipation.
Operculina turpethum: It contains glycosidium resin, glycoside (turoethin) and volatile oil. If is a good laxative and helpful in other abdominal troubles. It is also helpful in managing the normal body temperature.
Salmalia malabarica: It contains minerals, starch, protein, fatty acid tannic acid and gallic acid. It is cooling, stimulant, tonic and demulcent. It is useful in haemorrhoid.
","Adult: 2-4 teaspoonful 2-3 times daily after meal.
Children: 1-2 teaspoonful 2-3 times daily after meal.
",,,"There is no absolute contraindications.
","There is no significant side effect.
","Not recommended for use during pregnancy and lactation.
",,,,,,"Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.
",8
+1833,23 herb formula to increase breast milk,23-herb-formula-to-increase-breast-milk-1833,,Herbal and Nutraceuticals,Promote the quality and quantity of milk,"This is a natural formula meant to promote the quality and quantity of milk. This is 100% safe and effective. It can be used as a tonic for physically weak nursing mothers. Breast milk production may increase within a couple of days. However, in order to ensure the best results, the mother should continue taking this preparation for at least 15 days.
","Herbal and Nutraceuticals
",,,,,,,,,,,,,,2
+27,Acarbose,acarbose-27,https://medex.com.bd/attachments/juAhLogLVI7rFQ37M2nziXLQYyXyzk/acarbose-prescribing-information,Alpha-Glucosidase inhibitor,Type 2 DM,"Acarbose is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
","Alpha-Glucosidase inhibitor
","In contrast to sulfonylureas, Acarbose does not enhance insulin secretion. The antihyperglycemic action of acarbose results from a competitive, reversible inhibition of pancreatic alpha-amylase and membrane-bound intestinal alpha-glucoside hydrolase enzymes. Pancreatic alpha-amylase hydrolyzes complex starches to oligosaccharides in the lumen of the small intestine, while the membrane-bound intestinal alpha-glucosidases hydrolyze oligosaccharides, trisaccharides, and disaccharides to glucose and other monosaccharides in the brush border of the small intestine. In diabetic patients, this enzyme inhibition results in a delayed glucose absorption and a lowering of postprandial hyperglycemia. Because its mechanism of action is different, the effect of Acarbose to enhance glycemic control is additive to that of sulfonylureas, insulin or metformin when used in combination. In addition, Acarbose diminishes the insulinotropic and weight-increasing effects of sulfonylureas. Acarbose has no inhibitory activity against lactase and consequently would not be expected to induce lactose intolerance.
","The recommended starting dosage of Acarbose is 25 mg given orally three times daily at the start (with the first bite) of each main meal. However, some patients may benefit from more gradual dose titration to minimize gastrointestinal side effects. This may be achieved by initiating treatment at 25 mg once per day and subsequently increasing the frequency of administration to achieve 25 mg t.i.d. Maintenance Dosage Once a 25 mg t.i.d. dosage regimen is reached, dosage of Acarbose should be adjusted at 4–8 week intervals based on one-hour postprandial glucose or glycosylated hemoglobin levels, and on tolerance. The dosage can be increased from 25 mg t.i.d. to 50 mg t.i.d. Some patients may benefit from further increasing the dosage to 100 mg t.i.d. The maintenance dose ranges from 50 mg t.i.d. to 100 mg t.i.d.
",,"Certain drugs tend to produce hyperglycemia and may lead to loss of blood glucose control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel-blocking drugs, and isoniazid. When such drugs are administered to a patient receiving Acarbose, the patient should be closely observed for loss of blood glucose control. When such drugs are withdrawn from patients receiving Acarbose in combination with sulfonylureas or insulin, patients should be observed closely for any evidence of hypoglycemia.
Patients Receiving Sulfonylureas or Insulin: Sulfonylurea agents or insulin may cause hypoglycemia. Acarbose given in combination with a sulfonylurea or insulin may cause a further lowering of blood glucose and may increase the potential for hypoglycemia. If hypoglycemia occurs, appropriate adjustments in the dosage of these agents should be made. Very rarely, individual cases of hypoglycemic shock have been reported in patients receiving Acarbose therapy in combination with sulfonylureas and/or insulin.
","Acarbose is contraindicated in patients with known hypersensitivity to the drug. Precose is contraindicated in patients with diabetic ketoacidosis or cirrhosis. Acarbose is also contraindicated in patients with inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction. In addition, Acarbose is contraindicated in patients who have chronic intestinal diseases associated with marked disorders of digestion or absorption and in patients who have conditions that may deteriorate as a result of increased gas formation in the intestine.
","Diarrhea, gas, upset stomach, constipation, or stomach pain may occur in the first few weeks of treatment as your body adjusts to this medication but usually improve with time. Follow your prescribed diet to help lessen these side effects. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
","Pregnancy Category B. The safety of Acarbose in pregnant women has not been established. A small amount of radioactivity has been found in the milk of lactating rats after administration of radiolabeled acarbose. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, Acarbose should not be administered to a nursing woman.
","Because of its mechanism of action, Acarbose when administered alone should not cause hypoglycemia in the fasted or postprandial state. Sulfonylurea agents or insulin may cause hypoglycemia. Because Acarbose given in combination with a sulfonylurea or insulin will cause a further lowering of blood glucose, it may increase the potential for hypoglycemia. Hypoglycemia does not occur in patients receiving metformin alone under usual circumstances of use, and no increased incidence of hypoglycemia was observed in patients when Acarbose was added to metformin therapy.
Oral glucose (dextrose), whose absorption is not inhibited by Acarbose, should be used instead of sucrose (cane sugar) in the treatment of mild to moderate hypoglycemia. Sucrose, whose hydrolysis to glucose and fructose is inhibited by Acarbose, is unsuitable for the rapid correction of hypoglycemia. Severe hypoglycemia may require the use of either intravenous glucose infusion or glucagon injection.
","Pediatric Use: safety and effectiveness of Acarbose in pediatric patients have not been established.
Geriatric Use: of the total number of subjects in clinical studies of Acarbose in the United States, 27% were 65 and over, while 4% were 75 and over. No overall differences in safety and effectiveness were observed between these subjects and younger subjects.
","Unlike sulfonylureas or insulin, an overdose of Acarbose will not result in hypoglycemia. An overdose may result in transient increases in flatulence, diarrhea, and abdominal discomfort which shortly subside. In cases of overdosage the patient should not be given drinks or meals containing carbohydrates (polysaccharides, oligosaccharides and disaccharides) for the next 4–6 hours.
",,,"Store below 25° C. Protect from moisture.
",12
+2040,Acalabrutinib,acalabrutinib-2040,https://medex.com.bd/attachments/dNgwLuBed8A0JOrBs2LkWcC8rcqCrF/acalabrutinib-prescribing-information,Tyrosine Kinase Inhibitor,Lymphoma,"Acalabrutinib is a kinase inhibitor indicated for the treatment of adult patients with:
+
+- Mantle cell lymphoma (MCL) who have received at least one prior therapy
+- This indication is approved under accelerated approval based on overall response rate Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials
+- Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
+
","Tyrosine Kinase Inhibitor
","Acalabrutinib is a small-molecule inhibitor of BTK. Acalabrutinib and its active metabolite, ACP-5862, form a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signaling molecule of the B cell antigen receptor (BCR) and cytokine receptor pathways. In B cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion. In nonclinical studies, acalabrutinib inhibited BTK-mediated activation of downstream signaling proteins CD86 and CD69 and inhibited malignant B-cell proliferation and tumor growth in mouse xenograft models.
","The recommended dose is 100 mg orally approximately every 12 hours; swallow whole with water and with or without food. Advise patients not to break, open, or chew capsules. Manage toxicities using treatment interruption, dose reduction, or discontinuation. Avoid Acalabrutinib in patients with severe hepatic impairment.
",,"
+- CYP3A Inhibitors: Avoid co-administration with strong CYP3A inhibitors. Dose adjustments may be recommended
+- CYP3A Inducers: Avoid co-administration with strong CYP3A inducers. Dose adjustments may be recommended
+- Gastric Acid Reducing Agents: Avoid co-administration with proton pump
+
",,"Most common adverse reactions (incidence ≥30%) were: anemia, neutropenia, upper respiratory tract infection, thrombocytopenia, headache, diarrhea, and musculoskeletal pain.
","Based on findings in animals, Acalabrutinib may cause fetal harm and dystocia when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. No data are available regarding the presence of Acalabrutinib or its active metabolite in human milk, its effects on the breastfed child, or on milk production.
","
+- Serious and Opportunistic Infections: Monitor for signs and symptoms of infection and treat promptly
+- Hemorrhage: Monitor for bleeding and manage appropriately
+- Cytopenias: Monitor complete blood counts regularly
+- Second Primary Malignancies: Other malignancies have occurred, including skin cancers and other solid tumors. Advise patients to use sun protection
+- Atrial Fibrillation and Flutter: Monitor for symptoms of arrhythmias and manage
+
",,,,,"Do not store above 30⁰C. Keep away from light and out of the reach of children.
",9
+1294,Abiraterone Acetate,abiraterone-acetate-1294,https://medex.com.bd/attachments/GwfKxGdNFq7PdGkfU2rcee5Gd4UmUz/abiraterone-acetate-prescribing-information,Cytotoxic Chemotherapy,Metastatic prostate cancer,"Abiraterone Acetate is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with
+
+- Metastatic castration-resistant prostate cancer (CRPC).
+- Metastatic high-risk castration-sensitive prostate cancer (CSPC).
+
","Cytotoxic Chemotherapy
","Abiraterone is an orally active inhibitor of the steroidal enzyme CYP17A1 (17 alpha-hydroxylase/C17,20 lyase). It inhibits CYP17A1 in a selective and irreversible manner via covalent binding mechanism. CYP17A1 is an enzyme that catalyzes the biosynthesis of androgen and is highly expressed in testicular, adrenal, and prostatic tumor tissue. More specifically, abiraterone inhibits the conversion of 17-hydroxyprognenolone to dehydroepiandrosterone (DHEA) by the enzyme CYP17A1 to decrease serum levels of testosterone and other androgens.
","Metastatic castration-resistant prostate cancer: Abiraterone 1,000 mg orally once daily with prednisone 5 mg orally twice daily.
Metastatic castration-sensitive prostate cancer: Abiraterone 1,000 mg orally once daily with prednisone 5 mg orally once daily.
Patients receiving Abiraterone should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. Abiraterone must be taken on an empty stomach with water at least 1 hour before or 2 hours after a meal. Do not crush or chew tablets.
Dose Modification:
+
+- For patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the Abiraterone starting dose to 250 mg once daily.
+- For patients who develop hepatotoxicity during treatment, hold Abiraterone until recovery. Retreatment may be initiated at a reduced dose. Abiraterone should be discontinued if patients develop severe hepatotoxicity.
+
",,"CYP3A4 Inducers: Avoid concomitant strong CYP3A4 inducers during Abiraterone treatment. If a strong CYP3A4 inducer must be co-administered, increase the Abiraterone dosing frequency.
CYP2D6 Substrates: Avoid co-administration of Abiraterone with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate.
","Hypersensitivity to the Abiraterone acetate or to any of the excipients of Abiraterone.
","The most common adverse reactions are fatigue, arthralgia, hypertension, nausea, edema, hypokalemia, hot flush, diarrhea, vomiting, upper respiratory infection, cough, and headache.
","The safety and efficacy of Abiraterone have not been established in females. Based on findings from animal studies and the mechanism of action, Abiraterone can cause fetal harm and potential loss of pregnancy. There are no human data on the use of Abiraterone in pregnant women. The safety and efficacy of Abiraterone have not been established in females. There is no information available on the presence of abiraterone acetate in human milk, or on the effects on the breastfed child or milk production.
","Mineralocorticoid excess: Closely monitor patients with cardiovascular disease. Control hypertension and correct hypokalemia before treatment. Monitor blood pressure, serum potassium and symptoms of fluid retention at least monthly.
Adrenocortical insufficiency: Monitor for symptoms and signs of adrenocortical insufficiency. Increased dosage of corticosteroids may be indicated before, during and after stressful situations.
Hepatotoxicity: Can be severe and fatal. Monitor liver function and modify, interrupt, or discontinue Abiraterone dosing as recommended.
Increased fractures and mortality in combination with radium Ra 223 dichloride: Use of Abiraterone plus prednisone/prednisolone in combination with radium Ra 223 dichloride is not recommended.
Embryo-Fetal Toxicity: Abiraterone can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception.
",,"Human experience of overdose with Abiraterone is limited. There is no specific antidote. In the event of an overdose, stop Abiraterone, undertake general supportive measures, including monitoring for arrhythmias and cardiac failure and assess liver function.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+2043,Abemaciclib,abemaciclib-2043,https://medex.com.bd/attachments/FeIjZxunLLEWBIIqIIYQgKj7uyJ0rR/abemaciclib-prescribing-information,Protein kinase inhibitor,Breast cancer,"Abemaciclib is a kinase inhibitor indicated:
+
+- in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20% as determined by an FDA approved test.
... Read more
Abemaciclib is a kinase inhibitor indicated:
+
+- in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20% as determined by an FDA approved test.
+- in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
+- in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
+- as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
+
","Protein kinase inhibitor
","Abemaciclib is an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6). These kinases are activated upon binding to D-cyclins. In estrogen receptor-positive (ER+) breast cancer cell lines, cyclin D1 and CDK4/6 promote phosphorylation of the retinoblastoma protein (Rb), cell cycle progression, and cell proliferation. In vitro, continuous exposure to abemaciclib inhibited Rb phosphorylation and blocked progression from G1 into S phase of the cell cycle, resulting in senescence and apoptosis. In breast cancer xenograft models, abemaciclib dosed daily without interruption as a single agent or in combination with antiestrogens resulted in reduction of tumor size.
","Abemaciclib tablets are taken orally with or without food.
+
+- Recommended starting dose in combination with fulvestrant, tamoxifen, or an aromatase inhibitor: 150 mg twice daily.
+- Recommended starting dose as monotherapy: 200 mg twice daily.
+- Dosing interruption and/or dose reductions may be required based on individual safety and tolerability.
+
",,"CYP3A Inhibitors: Avoid concomitant use of ketoconazole. Reduce the Abemaciclib dose with concomitant use of other strong and moderate CYP3A inhibitors.
CYP3A Inducers: Avoid concomitant use of strong and moderate CYP3A inducers.
",,"Most common adverse reactions (incidence ≥20%) were diarrhea, neutropenia, nausea, abdominal pain, infections, fatigue, anemia, leukopenia, decreased appetite, vomiting, headache, alopecia, and thrombocytopenia.
","Based on findings from animal studies and the mechanism of action, Abemaciclib can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of abemaciclib to pregnant rats during the period of organogenesis caused teratogenicity and decreased fetal weight at maternal exposures that were similar to the human clinical exposure based on area under the curve (AUC) at the maximum recommended human dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Abemaciclib and for 3 weeks after the last dose.
","Diarrhea: Abemaciclib can cause severe cases of diarrhea, associated with dehydration and infection. Instruct patients at the first sign of loose stools to initiate antidiarrheal therapy, increase oral fluids, and notify their healthcare provider.
Neutropenia: Monitor complete blood counts prior to the start of Abemaciclib therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated.
Interstitial Lung Disease (ILD)/Pneumonitis: Severe and fatal cases of ILD/pneumonitis have been reported. Monitor for clinical symptoms or radiological changes indicative of ILD/pneumonitis. Permanently discontinue Abemaciclib in all patients with Grade 3 or 4 ILD or pneumonitis.
Hepatotoxicity: Increases in serum transaminase levels have been observed. Perform liver function tests (LFTs) before initiating treatment with Abemaciclib. Monitor LFTs every two weeks for the first two months, monthly for the next 2 months, and as clinically indicated.
Venous Thromboembolism: Monitor patients for signs and symptoms of thrombosis and pulmonary embolism and treat as medically appropriate.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of potential
","Pediatric Use: The safety and effectiveness of Abemaciclib have not been established in pediatric patients.
Geriatric Use: No overall differences in safety or effectiveness of Abemaciclib were observed between these patients and younger patients.
Renal Impairment: No dosage adjustment is required for patients with mild or moderate renal impairment.
Hepatic Impairment: No dosage adjustments are necessary in patients with mild or moderate hepatic impairment
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+24,Abacavir + Lamivudine + Zidovudine,abacavir-lamivudine-zidovudine-24,https://medex.com.bd/attachments/JjAbumA6DAWAzCnAt5cT4iKWEvz5Ik/abacavir-lamivudine-zidovudine-prescribing-information,Drugs for HIV / Anti-retroviral drugs,HIV infection,"This is indicated in combination with other antiretrovirals or alone for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
","Drugs for HIV / Anti-retroviral drugs
","Abacavir is a carbocyclic synthetic nucleoside analogue and an antiviral agent. Intracellularly, abacavir is converted by cellular enzymes to the active metabolite carbovir triphosphate, an analogue of deoxyguanosine-5'-triphosphate (dGTP). Carbovir triphosphate inhibits the activity of HIV-1 reverse transcriptase (RT) both by competing with the natural substrate dGTP and by its incorporation into viral DNA. Viral DNA growth is terminated because the incorporated nucleotide lacks a 3'-OH group, which is needed to form the 5′ to 3′ phosphodiester linkage essential for DNA chain elongation.
Lamivudine is a synthetic nucleoside analogue and is phosphorylated intracellularly to its active 5'-triphosphate metabolite, lamivudine triphosphate (L-TP). This nucleoside analogue is incorporated into viral DNA by HIV reverse transcriptase and HBV polymerase, resulting in DNA chain termination.
Zidovudine, a structural analog of thymidine, is a prodrug that must be phosphorylated to its active 5′-triphosphate metabolite, zidovudine triphosphate (ZDV-TP). It inhibits the activity of HIV-1 reverse transcriptase (RT) via DNA chain termination after incorporation of the nucleotide analogue. It competes with the natural substrate dGTP and incorporates itself into viral DNA. It is also a weak inhibitor of cellular DNA polymerase α and γ.
","Recommended dosage for adults and pediatric patients weighing at least 40 kg: The recommended dosage is one tablet taken orally twice daily with or without food.
Due to fixed-dose tablet and cannot be dose adjusted, this is not recommended for:
+
+- Pediatric patients who weigh less than 40 kg.
+- Patients with creatinine clearance less than 50 ml/minute
+- Patients with mild hepatic impairment.
+
",,"Abacavir: In a trial of 11 HIV-1-infected subjects receiving methadone-maintenance therapy with 600 mg twice daily (twice the currently recommended dose), oral methadone clearance increased. This alteration will not result in a methadone dose modification in the majority of patients; however, an increased methadone dose may be required in a small number of patients.
Lamivudine: Coadministration of single doses of lamivudine and sorbitol resulted in a sorbitol dose-dependent reduction in lamivudine exposures. When possible, avoid use of sorbitol-containing medicines with lamivudine-containing medicines
Zidovudine: Concomitant use of zidovudine with the following drugs should be avoided since an antagonistic relationship has been demonstrated in vitro: Stavudine, Doxorubicin, Nucleoside analogues, e.g., ribavirin
","This is contraindicated in patients:
+
+- Who have the HLA-B*5701 allele
+- With prior hypersensitivity reaction to abacavir, lamivudine, or zidovudine.
+- With moderate or severe hepatic impairment.
+
","The most commonly reported adverse reactions (incidence at least 10%) in clinical trials were nausea, headache, malaise and fatigue, and nausea and vomiting.
","Pregnancy Category C. There are no adequate and well-controlled studies of this preparation in pregnant women. This drug should be used during pregnancy only if the potential benefits outweigh the risks. Women infected with HIV should be instructed not to breastfeed due to potential for HIV transmission.
","Serious and sometimes fatal hypersensitivity reactions have occurred with abacavir, a component of this preparation. These hypersensitivity reactions have included multi-organ failure and anaphylaxis and typically occurred within the first 6 weeks of treatment with abacavir (median time to onset was 9 days); although abacavir hypersensitivity reactions have occurred any time during. Patients who carry the HLA-B*5701 allele are at a higher risk of abacavir hypersensitivity reactions; although, patients who do not carry the HLA-B*5701 allele have developed hypersensitivity reactions. Hypersensitivity to abacavir was reported in approximately 206 (8%) of 2,670 patients in 9 clinical trials with abacavir-containing products where HLA-B*5701 screening was not performed. The incidence of suspected abacavir hypersensitivity reactions in clinical trials was 1% when subjects carrying the HLA-B*5701 allele were excluded. In any patient treated with abacavir, the clinical diagnosis of hypersensitivity reaction must remain the basis of clinical decision making.
",,"There is no known specific treatment for overdose with this preparation. If overdose occurs, the patient should be monitored and standard supportive treatment applied as required.
",,,"Store at a dry and cool place. Protect from light and moisture. Keep the medicine out of the reach of children.
",11
+1776,Ciclopirox Olamine (Nail Lacquer),ciclopirox-olamine-nail-lacquer-1776,https://medex.com.bd/attachments/Atilz8YhEwi7NURu1np1pULzaHGreO/ciclopirox-olamine-nail-lacquer-prescribing-information,Other preparations,Onychomycosis,"Ciclopirox Nail Lacquer is indicated as a topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails (without lunula involvement) due to Trichophyton rubrum.
","Other preparations
","Ciclopirox is a synthetic antifungal agent. Ciclopirox Nail Lacquer is a clear, colorless to slightly yellowish solution. It is intended for topical use on fingernails and toenails and immediately adjacent skin In contrast to the azoles and other antimycotic drugs, the mechanism of action of Ciclopirox is poorly understood. However, loss of function of certain catalase and peroxidase enzymes of fungi has been Implicated as the mechanism of action, as well as various other components of cellular metabolism.
","
+- Before starting treatment, any loose nail or nail material should be removed using nail clippers or nail files. If one has diabetes or problems with numbness in toes or fingers, he/she should talk to the health care provider before trimming the nails or removing any nail material
+- Ciclopirox Nail Lacquer should be applied evenly over the entire nail plate once daily (preferably at bedtime or eight hours before washing) to all affected nails with the applicator brush provided. If possible, It should be applied to the underside of the nail and to the skin beneath it. The nail lacquer should be allowed to dry approximately 30 seconds before putting on socks or stockings
+- Ciclopirox Nail Lacquer should be applied daily over the previous coat
+- Once a week. Ciclopirox Nail Lacquer should be removed with an alcohol pad (nail polish remover). Using scissors, clippers, or nail files, the damaged nail should be removed as much as possible.
+- This cycle (steps 2 through 4) should be repeated throughout the duration of therapy (6 months to 48 weeks).
+
",,"No studies have been conducted to determine whether Ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. Therefore, the concomitant use of Ciclopirox 8% topical solution and systemic antifungal agents for onychomycosis is not recommended.
","Ciclopirox Nail Lacquer is contraindicated in individuals who have shown hypersensitivity to any of its components.
","Commonly redness/burning of treated skin or changes in shape/color of the nail may occur. Very serious allergic reaction to Ciclopirox is rare.
","Pregnancy Category B. There are no adequate or well-controlled studies of topically applied ciclopirox in pregnant women. Ciclopirox Nail Lacquer should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when Ciclopirox Nail Lacquer is administered to a nursing woman.
","If a reaction suggesting sensitivity or chemical irritation occurs with the use of Ciclopirox Nail Lacquer there is no relevant clinical experience with patients with insulin treatment should be discontinued. So far dependent diabetes or who have diabetic neuropathy. The risk of removal of the unattached, infected nail should be carefully considered before prescribing to patients with a history of insulin-dependent diabetes mellitus or diabetic neuropathy.
Ciclopirox Nail Lacquer is not for ophthalmic oral, or intravaginal use. For use on nails and immediately adjacent skin only.
","Use in Children: Ciclopirox Nail Lacquer is considered sale for use in children of 12 years and older. No clinical trials have been conducted in the pediatric population.
",,,,"Do not store above 30°C. Protect Ciclopirox Nail Lacquer from heat. Keep the bottle tightly closed Keep away from light and out of the reach of children.
",11
+293,Ciclopirox Olamine (Cream),ciclopirox-olamine-cream-293,https://medex.com.bd/attachments/8pfKo52HhbGzh0yru6CvpGqS8Pq6Zw/ciclopirox-olamine-cream-077-cream-prescribing-information,Topical Antifungal preparations,Tinea (pityriasis) versicolor,"Ciclopirox Cream is indicated for the topical treatment of the following dermal infections: Tinea pedis, Tinea cruris and Tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum and Microsporum canis, candidiasis (moniliasis) due to Candida albicans, and Tinea ... Read more
Ciclopirox Cream is indicated for the topical treatment of the following dermal infections: Tinea pedis, Tinea cruris and Tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum and Microsporum canis, candidiasis (moniliasis) due to Candida albicans, and Tinea (pityriasis) versicolor due to Malassezia furfur. Ciclopirox Cream is also highly effective against some gram negative & some gram-positive bacteria. Owing to its anti-inflammatory effects, Ciclopirox Olamine alone is sufficient to treat mild to moderate inflammatory fungal infections
","Topical Antifungal preparations
","Ciclopirox Olamine is a synthetic broad spectrum antifungal agent that inhibits the growth of pathogenic dermatophytes, yeasts, and Malassezia furfur. Ciclopirox Olamine exhibits fungicidal activity in vitro against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, and Candida albicans. The mode of action of Ciclopirox Olamine was studied mainly in Candida albicans. It is presumed that Ciclopirox Olamine mediated growth inhibition or death of fungal cells is primarily caused by in vitro cellular depletion of some essential substrates and/or ions and that such effects are brought about through blockage of their uptake from the medium.In addition to its broad spectrum of antifungal action, Ciclopirox also exerts antibacterial activity against many Gram-positive and Gram-negative bacteria. Theanti-inflammatory effects of Ciclopirox have been demonstratedin human polymorphonuclear cells, where Ciclopirox has inhibited the synthesis of prostaglandin and leukotriene. Ciclopirox can also exhibit its anti-inflammatory effects by inhibiting the formation of 5-lipoxygenase and cyclooxygenase.
","Ciclopirox Cream should be gently massaged onto the affected and surrounding skin areas twice daily for four weeks. Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment. If a patient shows no clinical improvement after four weeks of treatment with Ciclopirox cream, the diagnosis should be redetermined. Patients with Tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.
Use in children: Safety and effectiveness in children below the age of 10 years have not been established.
",,,"Ciclopirox Olamine cream is contraindicated in individuals who have shown hypersensitivity to any of its components.
","Ciclopirox Olamine cream is well tolerated with a low incidence of adverse reactions reported in clinical trials.
","Pregnancy category B. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ciclopirox Olamine cream or is administered to nursing women.
","Ciclopirox Olamine cream is not for ophthalmic use.
",,,,,"Store below 25°C, protect from light.Keep out of the reach of children.
",9
+254,Ciclesonide (Nasal Spray),ciclesonide-nasal-spray-254,https://medex.com.bd/attachments/2rnXMayBTn4fgtnXsEeEVxzRuK57Gd/ciclesonide-nasal-spray-prescribing-information,Respiratory corticosteroids,Perennial or seasonal allergic rhinitis,"Ciclesonide nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in patients aged 6 years and older and perennial allergic rhinitis in patients aged 12 years and older.
","Respiratory corticosteroids
","Ciclesonide nasal spray is a corticosteroid with anti-inflammatory activity. It is an aqueous suspension of ciclesonide for topical administration to the nasal mucosa by means of a metering and atomizing spray pump. It is necessary to prime the pump before first use or after a period of non-use (4 days or more).
","1 spray (50 micrograms/spray) in each nostril once a day. The maximum total daily dosage should not exceed 2 sprays in each nostril (200 micrograms/day).
Priming information: Gently shake the bottle and prime Ciclesonide nasal spray by actuating eight times before using for the first time or when not used for 4 consecutive days.
","How to use the Nasal Spray-
+
+- Shake the bottle gently and remove the dust cover.
+- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
+- Gently blow the nose to clear the nostrils.
+- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
+- Breathe out through your mouth.
+- Repeat the above steps in the same/ other nostril for consecutive doses.
+
+Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-
+
+- Remove the dust cover.
+- Gently pull off the nasal applicator.
+- Wash the applicator and dust cover in warm water.
+- Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
+- Gently push the applicator back on the top of the bottle and re-fix the dust cover.
+
",,,"Ciclesonide nasal spray is absorbed less into rest of the body; therefore fewer side effects are seen. However, few side-effects like headache, dizziness, nosebleed, stuffy nose, earache may occur.
","Pregnancy category C. Ciclesonide nasal spray should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. It is not known if Ciclesonide is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be used when administered to nursing women.
","Ciclesonide nasal spray should be used with caution in patients with active or quiescent tuberculosis infection of the respiratory tract or in patients with untreated fungal, bacterial or systemic viral infections or ocular herpes simplex. Rare instances of nasal septal perforation, cataract, and glaucoma have been reported following intranasal application. Development of localized infections of the nose and pharynx with Candida albicans has rarely occurred. Although systemic effects have been minimal with recommended doses of Ciclesonide nasal spray, potential risk increases with larger doses. Therefore, larger than recommended doses of Ciclesonide nasal spray should be avoided.
",,,,,"Store at a temperature not exceeding 30°C. Do not refrigerate. Protect from light and moisture. Keep away from eyes. Keep out of the reach of children. The bottle should be discarded after 120 actuations or 4 months after opening the pouch.
",9
+1840,Ciclesonide (Inhalation Aerosol),ciclesonide-inhalation-aerosol-1840,https://medex.com.bd/attachments/0PlkYwiRoiWa8f4brVCCk83madWegA/ciclesonide-inhalation-aerosol-prescribing-information,Respiratory corticosteroids,Asthma,"Ciclesonide inhalation aerosol is indicated for treatment to control persistent asthma in adults (18 years and older).
","Respiratory corticosteroids
","Ciclesonide, which is a new once daily inhaled corticosteroid, is an ester prodrug that requires hydrolyzation by endogenous esterases in the lung to form its active metabolite (B-9207-021). The activated ciclesonide has an approximately 100-fold greater affinity for glucocorticoid receptors compared with the parent compound and produces high local anti-inflammatory activity.
","Ciclesonide is for inhalation use only. The recommended starting dose of Ciclesonide is 160 micrograms once daily which is usually also the maximum dose. Dose reduction to 80 micrograms once daily may be an effective maintenance dose for some patients. Ciclesonide should preferably be administered in the evening although morning dosing of Ciclesonide has also been shown to be effective. There is no need to adjust the dose in elderly patients or those with hepatic or renal impairment. Patients with severe asthma are at risk of acute attacks and should have regular assessments of their asthma control including pulmonary function tests. Increasing use of short-acting bronchodilators to relieve asthma symptoms indicates deterioration of asthma control. If patients find that short-acting relief bronchodilator treatment becomes less effective, or they need more inhalations than usual, medical attention must be sought. In this situation, patients should be reassessed and consideration given to the need for increased anti-inflammatory treatment therapy (e.g. higher doses of Ciclesonide or a course of oral corticosteroids). Severe asthma exacerbations should be managed in the usual way.
","Before using your inhaler for the first time, or if it has not been used for a week or more, ""test fire"" it, i.e. release one puff into the air.
How to use your inhaler correctly:
+
+- Remove the mouthpiece cover, and check the mouthpiece thoroughly to see that it is clean. Shake the inhaler vigorously.
+- Hold the inhaler as shown between index finger and thumb. Breathe out gently through your mouth and immediately place the mouthpiece in your mouth between your teeth (Do not bite it).
+- Grip the mouthpiece firmly with your lips. Tilt your head slightly backwards. Start breathing in slowly through your mouth. At the same time press the canister as shown, to release one dose while continuing to breathe in steadily and deeply.
+- Remove the inhaler from your mouth. Hold the breath at least for 10 seconds, or as long as it is comfortable. Breathe out slowly.
+- If another dose is required, wait for at least 1 minute and repeat the whole process. After use, place the cover to close the mouthpiece.
+- Shake well before each use.
+
+
How to clean your inhaler:
+
+- Gently pull the metal canister out of the plastic body of the inhaler, remove the mouthpiece cover.
+- Rinse the plastic body and the mouthpiece cover in warm water but do not put the metal canister into water.
+- Leave to dry in warm place, avoid excessive heat.
+- Replace the canister and the mouthpiece cover correctly.
+- Clean your inhaler at least once a week.
+
","Co-administration with a potent inhibitor of the cytochrome P450 3A4 system (e.g. ketoconazole, itraconazole and ritonavir or nelfinavir) should be considered with caution. The risk of clinical adverse effect (eg cushingoid syndrome) cannot be excluded.
","Hypersensitivity to Ciclesonide or any of the excipients.
","Common (1-10%): Paradoxical bronchospasm; uncommon (0.1-1%): Bad taste, application site reactions, application site dryness, hoarseness, cough after inhalation, rash and eczema.
Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. Patients with severe hepatic impairment should be monitored for potential systemic effects.
","As with other inhaled glucocorticoids, Ciclesonide should only be used during pregnancy or lactation if the potential benefit to the mother justifies the potential risk to the mother, foetus or child. The lowest effective dose of Ciclesonide needed to maintain adequate asthma control should be used.
","As with all inhaled corticosteroids, Ciclesonide should be administered with caution in patients with active or quiescent pulmonary tuberculosis, fungal, viral, or bacterial infections, and only if these patients are adequately treated. As with all inhaled corticosteroids, Ciclesonide is not indicated in the treatment of status asthmaticus where intensive measures are required, or to relieve acute asthma symptoms for which an inhaled short-acting bronchodilator is required. Patients should be advised to have such rescue medication available. Patients transferred from oral steroids should be monitored regularly and their dose of systemic steroid reduced cautiously. Treatment with Ciclesonide should not be stopped abruptly.
",,,,,"The inhaler should be stored below 30°C, protected from direct sunlight and heat. The canister should not be broken, punctured or burnt, even when apparently empty. Keep away from eyes. Keep out of reach of children.
",11
+1176,Choriogonadotropin Alpha,choriogonadotropin-alpha-1176,https://medex.com.bd/attachments/ivaqoFKEYKORw3L7Xz9QU0B5QZm4iq/choriogonadotropin-alpha-prescribing-information,Female Sex hormones,Male Hypogonadotropic Hypogonadism,"Choriogonadotropin alfa injection is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted ... Read more
Choriogonadotropin alfa injection is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer. Choriogonadotropin alfa PreFilled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure.
Selection Of Patients:
+
+- Before treatment with gonadotropins is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. This should include an assessment of pelvic anatomy. Patients with tubal obstruction should receive Choriogonadotropin Alfa PreFilled Syringe only if enrolled in an in vitro fertilization program.
+- Primary ovarian failure should be excluded by the determination of gonadotropin levels.
+- Appropriate evaluation should be performed to exclude pregnancy.
+- Patients in later reproductive life have a greater predisposition to endometrial carcinoma as well as a higher incidence of anovulatory disorders. A thorough diagnostic evaluation should always be performed in patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities before starting FSH and Choriogonadotropin Alfa PreFilled Syringe therapy.
+- Evaluation of the partner's fertility potential should be included in the initial evaluation.
+
","Female Sex hormones
","The physicochemical, immunological, and biological activities of recombinant hCG are comparable to those of placental and human pregnancy urine-derived hCG. Choriogonadotropin alfa stimulates late follicular maturation and resumption of oocyte meiosis, and initiates rupture of the pre-ovulatory ovarian follicle. Choriogonadotropin alfa, the active component of Choriogonadotropin Alpha PreFilled Syringe, is an analogue of Luteinizing Hormone (LH) and binds to the LH/hCG receptor of the granulosa and theca cells of the ovary to effect these changes in the absence of an endogenous LH surge. In pregnancy, hCG, secreted by the placenta, maintains the viability of the corpus luteum to provide the continued secretion of estrogen and progesterone necessary to support the first trimester of pregnancy. Choriogonadotropin Alpha PreFilled Syringe is administered when monitoring of the patient indicates that sufficient follicular development has occurred in response to FSH treatment for ovulation induction.
","Infertile Women Undergoing Assisted Reproductive Technologies (ART): Choriogonadotropin Alfa PreFilled Syringe 250 μg should be administered one day following the last dose of the follicle stimulating agent. Choriogonadotropin Alfa PreFilled Syringe should not be administered until adequate follicular development is indicated by serum estradioland vaginal ultrasonography. Administration should be withheld in situations where there is an excessive ovarian response, as evidenced by clinically significant ovarian enlargement or excessive estradiol production.
Infertile Women Undergoing Ovulation Induction (OI): Choriogonadotropin Alfa PreFilled Syringe should not be administered until adequate follicular development is indicated by serum estradiol and vaginal ultrasonography. Choriogonadotropin Alfa PreFilled Syringe 250 μg should be administered one day following the last dose of the follicle stimulating agent. Choriogonadotropin Alfa PreFilled Syringe administration should be withheld in situations where there is an excessive ovarian response, as evidenced by multiple follicular development, clinically significant ovarian enlargement or excessive estradiol production.
","For Subcutaneous Use Only. Directions For Administration Of Choriogonadotropin Alfa Prefilled Syringe is intended for a single subcutaneous injection. Any unused material should be discarded. Choriogonadotropin Alfa PreFilled Syringe may be self-administered by the patient. Follow the directions below for injecting Choriogonadotropin Alfa PreFilled Syringe.
Step 1: Wash your hands thoroughly with soap and water.
Step 2: Carefully clean the injection site: Make yourself comfortable by sitting or lying down. Carefully clean the injection site on the stomach with an alcohol wipe and allow it to air-dry.
Step 3: Administer your injection: Carefully remove the needle cap from the syringe. Do not touch the needle or allow the needle to touch any surface. Inject the prescribed dose as directed by your doctor, nurse or pharmacist.
Step 4: Gently withdraw the needle: Discard the needle and syringe into your safety container. Place gauze over the injection site. If any bleeding occurs, apply gentle pressure. If bleeding does not stop within a few minutes, place a clean piece of gauze over the injection site and cover it with an adhesive bandage.
Step 5: Storage and clean up: Remember that your injection materials must be kept sterile and cannot be reused.
","Drng & other interactions: No clinically significant drug interactions have been reported during hCG therapy. Following administration, Ovidrel (choriogonadotrophin alfa) may interfere for up to ten days with the immunological determination of serum/urinary hCG, leading to a false positive pregnancy test. During Ovidrel therapy, a minor thyroid stimulation is possible of which the clinical relevance is unknown.
","Choriogonadotropin Alpha PreFilled Syringe is contraindicated in women who exhibit:
+
+- Prior hypersensitivity to hCG preparations or one of their excipients.
+- Primary ovarian failure.
+- Uncontrolled thyroid or adrenal dysfunction.
+- An uncontrolled organic intracranial lesion such as a pituitary tumor.
+- Abnormal uterine bleeding of undetermined origin
+- Ovarian cyst or enlargement of undetermined origin
+- Sex hormone dependent tumors of the reproductive tract and accessoryorgans.
+- Pregnancy.
+
","Injection site inflammation and reaction, flatulence, diarrhea, hiccup, ectopic pregnancy, breast pain, intermenstrual bleeding, vaginal hemorrhage, cervical lesion, leukorrhea, ovarian hyperstimulation, uterine disorders, vaginitis, vaginal discomfort, body pain, back pain, fever, dizziness, headache, hot flashes, malaise, paraesthesias, rash, emotional lability, insomnia, upper respiratory tract infection, cough, dysuria, urinary tract infection, urinary incontinence, albuminuria, cardiac arrhythmia, genital moniliasis, genital herpes, leukocytosis, heart murmurand cervical carcinoma.
","Pregnancy Category X. Intrauterine death and impaired parturition were observed in pregnant rats given a dose of urinary-hCG (500 IU) equivalent to three times the maximum human dose of 10,000, based on body surface area.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if hCG is administered to a nursing woman.
","Gonadotropins, including Choriogonadotropin Alpha PreFilled Syringe (choriogonado-tropin alfa injection), should only be used by physicians who are thoroughly familiar with infertility problems and their management. Like other hCG products, Choriogonadotropin Alpha PreFilled Syringe is a potent gonadotropic substance capable of causing OvarianHyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascularcomplications. The risks of gonadoptropin treatment should be considered for women with risk factors of thromboembolic events such as prior medical or family history. Gonadotropin therapy requires a certain time commitment by physicians and supportive health professionals, and requires the availability of appropriate monitoring facilities. Safe and effective induction of ovulation and use of Choriogonadotropin Alpha PreFilled Syringe in women requires monitoring of ovarian response with serum estradiol and transvaginal ultrasound on a regular basis.
","Pediatric Patients: Safety and effectiveness in pediatric patients has not been established.
Geriatric Patients: Safety and effectiveness in geriatric patients has not been established.
",,,,"The Choriogonadotropin Alfa PreFilled Syringe must be stored refrigerated between 2-8° C before being dispensed to the patient. Patients should store the pre-filled syringe refrigerated to allow the product to be used until the expiry date shown on the syringe or carton. The Choriogonadotropin Alfa PreFilled Syringe may be stored by the patient for no more than 30 days at room temperature up to 25° C but must be used within those 30 days. Protect from light. Store in original package. Discard unused material.
",12
+905,Cholera Saline,cholera-saline-905,,Intravenous fluid preparations,Vomiting,"Cholera Saline contains different electrolytes which are usually depleted in various conditions e.g. diarrhoea, vomiting, profuse sweating etc. So, this saline is indicated in cholera, also in diarrhoea, vomiting, fluid loss, to replenish and restore the normal electrolyte balance of the body.
","Intravenous fluid preparations
",,"The volume and rate of infusion of Cholera Saline depends upon the requirements of the patient and the judgement of the physician. It usually varies with age, weight and clinical condition of the patient.
","Administration Procedure:
+
+- Check infusion set and infusion solution prior to use
+- Pull moderately to tear off the protective cover of the Eurohead
+- Hold lightly the Eurohead but not the bag
+- Open the flow regulator fully and hold the giving set on the top white area, but not the membrane venting region
+- Insert the spike of the administration set to the Eurohead and fit the connector of the administration set firmly to the needle
+- Gradually allow the fluid to flow down to the needle tip and close
+- Remove the protective cover of the needle
+- Locate the venipuncture site and clean the site with an antiseptic solution, and then insert the needle
+- Securely tape the puncture site
+- Securely tape the wings and tubing
+- Start infusion while adjusting drip speed
+
",,,"
+- Severe burning, pain, or swelling around the IV needle;
+- Warmth, redness, oozing, or bleeding where the IV was placed;
+- fever, ongoing cough.
+
",,"Since Cholera Saline contains different electrolytes, it should be infused with caution in patients where electrolyte imbalance may cause detrimental effects, e.g. in pregnancy, renal impairment, heart failure, pulmonary congestion, head injury etc. or in patients receiving potassium sparing diuretics.
",,,,,"Should be stored at controlled room temperature.
",7
+251,Chlorthalidone,chlorthalidone-251,https://medex.com.bd/attachments/nXuoTR0JoQiJjMnqM9GuYHqz3Zm7Xx/chlorthalidone-prescribing-information,Thiazide diuretics & related drugs,Oedema,"Chlorthalidone is indicated in the management of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis and corticosteroid and estrogen therapy.
","Thiazide diuretics & related drugs
","Chlorthalidone is a thiazide-type Diuretic- Antihypertensive, used for the treatment of hypertension. It may be used alone or in association with other antihypertensive agents. Chlortalidone is also indicated for adjunctive therapy of edema associated with: renal disease; congestive heart failure of mild to moderate degree (functional class II, Ill), when glomerular filtration rate is greater than 30 ml/min; ascites due to cirrhosis of the liver in stable patients; estrogen therapy; corticosteroid therapy.
Chlorthalidone inhibits the reabsorption of sodium and chloride in the distal renal tubule thus promoting water loss. The higher urine volume increases potassium loss. Little information is available on the absorption of the drug. Its long elimination half-life and clinical experience place it as a long-acting thiazide derivative. The longer-acting agents appear to cause increased potassium loss.
Although a mild diuretic, its combination with loop diuretics is particularly potent because the latter presents much more sodium chloride to the distal tubule.
The blood pressure lowering effects are initially due to volume reduction but the persisting effect includes other undetermined mechanisms that reduce peripheral resistance. A high salt intake reverses its antihypertensive effect.
The major portion of an absorbed dose of Chlorthalidone is excreted by the kidneys with an elimination half life averaging 50 hours. Metabolism and hepatic excretion into the bile constitute a minor way of elimination. Within 120 hours, about 70% of the dose is excreted in the urine and in the feces, mainly in an unchanged form.
","Therapy should be initiated with the lowest possible dose, and be titrated thereafter to gain maximum therapeutic benefit while keeping side effects to a minimum (e.g. determine the minimum effective maintenance dose for each patient). A single dose daily or every other day is given in the morning with food is recommended.
Hypertension: Usual adult dose is 25 to 50 mg daily. The clinically useful dosage range is 12.5 to 50 mg daily. Doses greater than 50 mg per day increase metabolic complications and are rarely of therapeutic benefit. For a given dose, the full effect is reached after 3 to 4 weeks. If the decrease in blood pressure obtained using doses of 25 or 50 mg/day proves inadequate, combined treatment with other antihypertensive drugs (such as beta-blockers and ACE inhibitors) is recommended. When adding an ACE inhibitor, Chlorthalidone is to be reduced or discontinued.
Edema of Specific Origin: The lowest effective dose is to be identified by titration. Maintenance doses should not exceed 50 mg/day and should be administered over limited periods only. The dosage should be individually adapted to the clinical picture and patient response. For long-term therapy, the lowest possible dosage sufficient to maintain an optimal effect should be employed; this applies particularly to elderly patients.
The therapeutic effect of Chlorthalidone occurs even without salt restriction and is well sustained during continued use.
The elderly: This is a suitable drug for treating hypertension in the elderly, in particular systolic hypertension. Dose of 50 mg daily, or less, should be used to avoid hypovolemia and hypokalemia.
",,"Other interactions: Patients with Special Diseases and Conditions in patients with impaired hepatic function or progressive liver disease, caution should be exercised since even minor alterations in fluid and electrolyte balance or of serum ammonia may precipitate hepatic coma. Treatment with thiazide diuretics should be initiated cautiously in postsympathectomy patients since the antihypertensive effects may be enhanced. A cautious dosage schedule should be adopted in patients with severe coronary or cerebral ateriosderosis.
Drug Interactions-
Antihypertensive Agents: Diuretics potentiate the action of curare derivatives and antihypertensive agents (e.g. guanethidine, methyldopa, beta-blockers, vasodilators, calcium antagonists, ACE inhibitors).
Digitalis: Thiazide-induced hypokalemia or hypomagnesemia may increase the likelihood of digitalis-induced cardiac arrhythmias (see also Precautions).
Corticosteroids: The hypokalemic effects of diuretics may be increased by corticosteroids, ACTH and amphotericin. Insulin and Oral Antidiabetic Agents: It may be necessary to adjust the dosage of insulin or oral antidiabetic agents in response to changes in glucose tolerance that Chlorthalidone may produce.
NSAIDs: Concomitant administration of certain NSAIDs (e.g. indomethacin) may weaken the diuretic and antihypertensive activity of thiazides, and there have been isolated reports of a deterioration of renal function in predisposed patients.
Curare Derivatives and Ganglionic Blocking Agents: Thiazides may increase responsiveness to curare derivatives and ganglionic blocking agents.
Allopurinol: Co-administration of thiazide diuretics may increase the incidence of hypersensitivity reactions to allopurinol.
Amantadine: Co-administration of thiazide diuretics may increase the risk of adverse effects from amantadine.
Antineoplastic Agents (e.g. cyclophosphamide, methotrexate): Concomitant use of thiazide diuretics may reduce renal excretion of cytotoxic agents and enhance the myelo suppressive effects. Anticholinergics (e.g. atropine, biperiden): The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents, apparently due to a decrease in gastrointestinal motility and rate of gastric emptying.
Cholestyramine: Absorption of thiazide diuretics is decreased by cholestyramine, therefore a decrease in pharmacological effect may be expected.
Vitamin D: Concomitant use of thiazide diuretics may decrease urinary excretion of calcium, and co-administration of Vitamin D may potentiate the increase in serum calcium.
Cyclosporin: Concomitant treatment with diuretics may increase the risk of hyperuricemia and gout-type complications.
Calcium Salts: Concomitant use of thiazide-type diuretics may cause hypercalcemia by increasing tubular calcium reabsorption.
Diazoxide: Thiazide diuretics may enhance the hyperglycemic effect of diazoxide.
","Anuria, severe renal failure (creatinine clearance lower than 30 mL/min), severe hepatic failure, refractory hypokalemia or conditions involving enhanced potassium loss, hyponatremia, hypercalcemia, symptomatic hyperuricemia (history of gout or uric acid calculi). Hypersensitivity or suspected hypersensitivity to Chlorthalidone and other sulfonamide derivatives or their excipients.
Should be used with caution in patients with renal disease or with impaired hepatic function. Because of the possibility of progression of renal damage, periodic determination of the BUN and serum creatinine are indicated. Should there be an elevation of either parameter, treatment should be discontinued. Like thiazides, Chlorthalidone may lose its diuretic efficacy when glomerular filtration rate drops below 30 mL/min, a point at which treatment with loop diuretics may be more appropriate.
Electrolytes: As with thiazide diuretics, kaluresis induced by Chlorthalidone is dose dependent, and there is inter-individual variability in magnitude. With 25 mg/day, serum potassium concentration decreases average 0.5 mmol/L. If chronic treatment is contemplated, serum potassium concentrations should be determined initially, and then 3 to 4 weeks later. If thereafter, potassium balance is not disturbed further, concentrations should be assessed every 4 to 6 months. Conditions that may alter potassium balance include: vomiting, diarrhea, malnutrition, change in renal function (e.g. nephrosis), liver cirrhosis, hyperaldosteronism, or concomitant use of corticosteroids or ACTH. Titrated co-administration of an oral potassium salt (e.g. KCI) may be considered in patients: receiving digitalis; exhibiting signs of coronary heart disease, unless they are also receiving an ACE inhibitor; on high doses of a beta-adrenergic agonist; whose plasma potassium concentrations are less than 3.0 mmol/L.
","Electrolytes and Metabolic Disorders: Frequent: mainly at higher doses, hypokalemia, hyperuricemia and rise in blood lipids. Occasional: hyponatremia, hypomagnesemia and hyperglycemia. Rare: hypercalcemia, glycosuria, worsening of diabetic metabolic state and gout.
Isolated cases: hypochloremic alkalosis.
Dermatology: Occasional: urticaria and other forms of skin rash. Rare: photosensitization.
Liver: Rare: Intrahepatic cholestasis or jaundice.
Cardiovascular: Occasional: postural hypotension, which may be aggravated by alcohol, anesthetics or sedatives. Rare: cardiac arrhythmias.
CNS: Occasional: dizziness, slow mentation and decreased reaction time.
","Pregnancy: Chlorthalidone, like other diuretics, can cause placental hypoperfusion. Since they do not prevent or alter the course of EPH (edema, proteinuria, hypertension) preeclampsia, these drugs must not be used to treat hypertension in pregnant women. The use of Chlorthalidone for other indications (e.g. heart disease) in pregnancy should be avoided, particularly in the first trimester, unless the potential benefits outweigh the possible risks (e.g. when there are no safer altenatives).
Lactation: Chlorthalidone appears in breast milk, attaining concentrations of approximately 4% of maternal blood levels. Therefore use in nursing mothers should be avoided.
","Renal impairment: Chlorthalidone dosage should be reduced in moderate renal failure - every 24 or 48 h - and should not be used in advanced renal failure.
Liver disease: There is a risk of precipitating hepatic encephalopathy in patients with liver cirrhosis and ascites.
Use in pregnancy: It is better to avoid Chlorthalidone as it crosses the placenta.
Use in Lactation: In lactating mother, significant amount of Chlorthalidone enter breast milk; like other long-acting thiazides, it can suppress lactation. Chlorthalidone should not be prescribed for lactating mother.
",,"Symptoms of acute overdosage include nausea, weakness, dizziness, and disturbances of electrolyte balance. The oral LD 50 of the drug in the mouse and the rat is more than 25,000 mg/kg body weight. The minimum lethal dose (MLD) in humans has not been established. There is no specific antidote, but gastric lavage is recommended, followed by supportive treatment. Where necessary, this may include intravenous dextrose-saline with potassium, administered with caution.
",,,"Store in a cool and dry place, protected from light.
",11
+250,Chlorpromazine Hydrochloride,chlorpromazine-hydrochloride-250,https://medex.com.bd/attachments/e0bsOvJurc22yOZy7RY5pdQiwydN79/chlorpromazine-hydrochloride-tablets-injection-prescribing-information,Anti-emetic drugs,Vomiting,"Chlorpromazine is indicated in the following conditions:
+
+- Schizophrenia and other psychoses (especially paranoid), mania and hypomania.
+- In anxiety psychomotor agitation excitement, violent or dangerously impulsive behaviour. Chlorpromazine is used as an adjunct in the short-term management of these conditions.
... Read more
Chlorpromazine is indicated in the following conditions:
+
+- Schizophrenia and other psychoses (especially paranoid), mania and hypomania.
+- In anxiety psychomotor agitation excitement, violent or dangerously impulsive behaviour. Chlorpromazine is used as an adjunct in the short-term management of these conditions.
+- Intractable hiccup.
+- Nausea and vomiting of terminal illness (where other medicines have failed or are not available).
+- Childhood schizophrenia and autism.
+
","Anti-emetic drugs, Phenothiazine drugs, Phenothiazine related drugs
","Chlorpromazine is a neuroleptic that acts by blocking the postsynaptic dopamine receptor in the mesolimbic dopaminergic system and inhibits the release of hypothalamic and hypophyseal hormones. It has antiemetic, serotonin-blocking, and weak antihistaminic properties and slight ganglion-blocking activity.
","Schizophrenia, Psychoses, Anxiety and Agitation
+Oral-
+
+- Adult: Initially 25 mg three times daily or 75 mg at bedtime increasing by daily amounts of 25 mg to an effective maintenance dose. This is usually in the range 75 to 300 mg daily, but some patients may require up to 1 g daily.
+- Children: Under 1 Year: Do not use unless need is life saving. 1-5 Years: 0.5 mg/kg bodyweight every 4 - 6 hours to a maximum recommended dose of 40 mg daily. 6-12 Years: A third to half the adult dose, to a maximum recommended dose of 75 mg daily.
+- Elderly: Start with a third to a half the usual adult dose with a more gradual increase in dosage.
+
+Intramuscular-
+
+- Adult: For acute relief of symptoms 25 - 50 mg every 6-8 hours.
+- Children: Under 1 Year: Do not use unless need is life saving. 1-5 Years: 0.5 mg/kg bodyweight every 6 - 8 hours. Dosage is not advised to exceed 40 mg daily. 6-12 Years: 0.5 mg/kg bodyweight every 6-8 hours. Not to exceed 75 mg daily.
+- Elderly: Doses in the lower range for adults should be sufficient to control symptoms, i.e. 25 mg, 8 hourly.
+
+
Intractable Hiccup (Adult)
+
+- Oral: 25-50 mg three or four times daily.
+- Intramuscular: 25-50 mg every 6-8 hours.
+- Intravenous Infusion: If other routes of administration are inappropriate, give 25-50 mg in 500-1000 ml sodium chloride by slow intravenous infusion every 6-8 hours.
+
+
Nausea and Vomiting of Terminal Illness
+Oral-
+
+- Adults: 10-25 mg every 4-6 hours.
+- Children: Under 1 Year: Do not use unless need is life saving. 1-5 Years: 0.5 mg/kg every 4 - 6 hours. Maximum daily dosage should not exceed 40 mg. 6-12 Years: 0.5 mg/kg every 4 - 6 hours. Maximum daily dosage should not exceed 75 mg.
+- Elderly: Initially a third to half the adult dose. The physician should then use their clinical judgement to obtain control.
+
+Intramuscular-
+
+- Adults: 25 mg initially, then 25 - 50 mg every 3 - 4 hours until vomiting stops, then drug to be taken orally.
+- Children: Under 1 Year: Do not use unless need is life saving. 1-5 Years: 0.5 mg/kg 6 - 8 hourly. It is advised that maximum daily dosage should not exceed 40 mg. 6-12 Years: 0.5 mg/kg every 6 - 8 hours. It is advised that maximum daily dosage should not exceed 75 mg.
+
","May be taken with or without food. May be taken with meals to reduce GI discomfort.
","Interactions resulting in decreased chlorpromazine levels: Food, alcohol and benztropine can reduce the absorption of chlorpromazine. Antacids can slow the absorption of chlorpromazine. Lithium and chronic administration of barbiturates can lead to increased clearance of chlorpromazine.
Interactions resulting in increased chlorpromazine levels: Tricyclic antidepressants decrease the clearance of chlorpromazine and may lead to increased serum levels. Administration of chlorpromazine with CYP1A2 inhibitors, in particular strong (such as ciprofloxacin and fluvoxamine) or moderate (such as oral contraceptives and vemurafenib) inhibitors leads to an increase in chlorpromazine plasma concentrations. Therefore, patients may experience any chlorpromazine dose-dependent adverse drug reaction.
","Chlorpromazine should never be used in the following circumstances:
+
+- Circulatory collapse.
+- CNS depression, e.g. coma or drug intoxication.
+- Previous history of a hypersensitivity reaction (e.g. jaundice or blood dyscrasia) to phenothiazines, especially chlorpromazine itself, or to any of the excipients contained in the tablets or injection.
+- Bone marrow depression.
+- Phaeochromocytoma.
+- Hepatic failure or active hepatic disease.
+- Chlorpromazine Injection contains sodium metabisulfite and sodium sulfite and may cause allergic-type reactions including anaphylactic symptoms and asthmatic episodes in susceptible people.
+
","The following adverse effects have been reported for chlorpromazine or phenothiazines in
general.
+
+- Cardiovascular: Postural hypotension, ECG Changes.
+- Dermatological
+- Contact dermatitis, photosensitivity, urticarial, maculopapular, petechial or oedematous reactions.
+- Endocrine: Elevated prolactin levels, impaired thermoregulation, hyperglycaemia, other hypothalamic effects.
+- Gastrointestinal: Dry mouth, constipation.
+- Immunological: Raised ANA titre, positive SLE cells.
+- Genitourinary: Urinary retention.
+- Haematological: Leucopenia, agranulocytosis, eosinophilia, hemolytic anaemia, aplastic anaemia, thrombocytopenic purpura and pancytopenia have been reported.
+
","Pregnancy category C. Studies in animals by oral route have shown reproductive toxicity (dose-related embryo fetotoxicity: increased resorptions and dead foetuses). Increased incidence of malformations was observed in mice but only at doses inducing maternal mortality. There is inadequate animal data regarding reproductive toxicity with chlorpromazine by parenteral route. In humans, the teratogenic risk of chlorpromazine has not been evaluated. Different prospective epidemiological studies conducted with other phenothiazines have yielded contradictory results regarding teratogenic risk. Chlorpromazine has been found to be excreted in breast milk in variable amounts, therefore it is not recommended for nursing mothers unless the expected benefits outweigh any potential risk.
","Chlorpromazine generally should not be used in epilepsy, Parkinson’s disease, hypoparathyroidism, myasthenia gravis and prostatic hypertrophy.
","Elderly: The elderly are relatively more susceptible to the adverse effects of chlorpromazine. The starting dose should be about half the usual adult dose and dosage increments should be gradual and reviewed regularly.
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+249,Chlorpheniramine Maleate,chlorpheniramine-maleate-249,https://medex.com.bd/attachments/0faAhEK3HmQlOpHnIypHdIjomD2BAm/chlorpheniramine-maleate-syrup-prescribing-information,Sedating Anti-histamine,Watery eye,"Chlorpheniramine Maleate is indicated in the following indications-
+
+- Urticaria
+- Sensitivity reactions
+- Angioneurotic edema
+- Vasomotor rhinitis
+- Cough
+- Common cold
+- Motion sickness and
+- Other allergic conditions.
+
","Sedating Anti-histamine
","Chlorpheniramine Maleate is an alkylamine antihistamine. It is one of the most potent histamine H1-receptor blocking agents which is used as a potent antihistamine. This generally causes less sedation than promethazine. Chlorpheniramine Maleate exerts its effects by blocking H1-receptor competitively.
","Adult- Usual adult dose is 4 mg every 4-6 hours, maximum 24 mg daily.
Child-
+
+- 6-12 years: 2 mg every 4-6 hours, maximum 12 mg daily.
+- 2-5 years: 1 mg every 4-6 hours, maximum 6 mg daily.
+- 1-2 years: 1 mg twice daily.
+
+Below 1 year the use of Chlorpheniramine Maleate is not recommended.
",,"Chlorphenamine maleate has been reported to be incompatible with calcium chloride, kanamycin sulfate, noradrenaline acid tartrate, pentobarbital sodium, and meglumine adipiodone.
","Chlorpheniramine is contraindicated in patients hypersensitive to this agent, in newborn or premature infants.
","Chlorpheniramine is well-tolerated, but sometimes drowsiness, dizziness, muscular weakness, and gastrointestinal upset may occur.
","This drug should not be used in lactating mother and in pregnancy especially during the first trimester of pregnancy.
","Chlorpheniramine should be used with caution in patients with glaucoma and prostatic hypertrophy. During therapy with chlorpheniramine, caution should be taken in driving vehicles and operating machinery.
",,"CNS depression (including sedation, apnea, CV collapse), CNS stimulation (including insomnia, hallucination, tremors, convulsions), tinnitus, blurred vision, dizziness, ataxia, hypotension. Stimulation and atropine-like signs and symptoms (including dry mouth, fixed dilated pupils, flushing, hyperthermia, Gl symptoms) are more likely in children.
",,,"Store in a cool (Below 25°C temperature) and dry place protected from light. Keep out of the reach of children.
",11
+296,Chloroxylenol + Triclosan,chloroxylenol-triclosan-296,,Chlorhexidine & Chloroxylenol preparations,Sunburn,"Chloroxylenol & Triclosan is indicated in Insect bites, Sunburn, Cuts, Scratches, Abrasions, Disinfection of the skin, Minor burns, Sore lips, Minor skin infections, Chapped roughened hands, Cracked itchy skin
","Chlorhexidine & Chloroxylenol preparations
","It is bactericidal against most gram-positive bacteria. Chloroxylenol is used in hospitals and households for disinfection and sanitation. It is also commonly used in antibacterial soaps, wound-cleansing applications and household antiseptics such as Dettol liquid (to which it contributes its distinctive odor), cream and ointments.
Triclosan, a chlorinated bisphenol antiseptic, is active against fungi, gram-positive and gram-negative bacteria.
","Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily.
children under 2 years of age: consult a doctor
",,"There are no known drug interactions and none well documented.
","Hypersensitivity
","Skin sensitivity; irritation of conjunctiva, mucosal irritation; reversible brown staining of the teeth; tongue discoloration and burning sensation; transient taste disturbance; parotid gland swelling.
","Pregnancy Category: Not Classified
FDA has not yet classified the drug into a specified pregnancy category.
","Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days
",,,,,,9
+1227,Chloroxylenol,chloroxylenol-1227,https://medex.com.bd/attachments/wKP3reRgy6N5T28AIKDmSb82vwtSar/chloroxylenol-prescribing-information,Chlorhexidine & Chloroxylenol preparations,Sunburn,"Disinfectant for skin and gloved hands; obstetrics, antiseptic lubricant for vaginal examinations and on forceps; for hand antisepsis .
","Chlorhexidine & Chloroxylenol preparations
","Chloroxylenol is used in hospitals and households for disinfection and sanitation. It is also commonly used in antibacterial soaps, wound-cleansing applications and household antiseptics such as liquid (to which it contributes its distinctive odor), cream and ointments.
","Wash with one table spoonful of Chloroxylenol to a tumbler of water (1 in 13) for urgent application, undiluted Chloroxylenol may be used but not in a sensitive skin.
",,"There are no known drug interactions and none well documented.
","Hypersensitivity
","Skin sensitivity; irritation of conjunctiva, mucosal irritation; reversible brown staining of the teeth; tongue discoloration and burning sensation; transient taste disturbance; parotid gland swelling.
","Pregnancy Category-Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
","Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days
",,,,,,9
+248,Chloroquine Phosphate,chloroquine-phosphate-248,https://medex.com.bd/attachments/c6mHXHTNdk3Hu4kEdiByuNmufGQBNq/chloroquine-phosphate-tablets-prescribing-information,Anti-malarial drugs,Systemic lupus erythematosus (SLE),"Chloroquine Phosphate is indicated in the following cases:
+
+- Treatment of malaria
+- Prophylaxis and suppression of malaria
+- Treatment of amoebic hepatitis and abscess
+- Treatment of discoid and systemic and systemic lupus erythematosus
+- Treatment of rheumatoid arthritis
+
","Anti-malarial drugs
","Chloroquine is used for malarial prophylaxis (as a suppressive) and in managing acute attacks of malaria. It is highly active against erythrocytic forms of P. vivax, P. malariae and P. falciparum. It influences Hb digestion by increasing intravesicular pH in malaria parasite cells and interferes with the nucleoprotein synthesis of the patient. It is also effective in extra intestinal amoebiasis. In RA chloroquine and more effectively hydroxychloroquine have a disease-modifying effect.
","Treatment of Malaria-
Partially immune adults:
+A single dose of 4 tablets. In severe attacks, the dosage schedule for non-immune adults should be adopted.
+
Partially immune children:
+
+- Under 1 year: 1-2 single dose (in 5 ml spoonful)
+- 1-3 years: 3-4 single dose (in 5 ml spoonful)
+- 3-6 years: 4-6 single dose (in 5 ml spoonful)
+- 6-9 years: 6-9 single dose (in 5 ml spoonful)
+
+In severe attacks, the dosage schedule for non-immune children should be adopted.
+
Non-immune adults:
+
+- P. falciparum infections: 4 tablets initially, 2 tablets after 6 to 8 hours and then 2 tablets per day for 2 days
+- P. vivax group infections: A single dose of four tablets followed by a course of treatment with primaquine phosphate (15 mg base daily for fourteen days)
+
+
Non-immune Children:
+Under 1 year:
+
+- 1-2 initial dose (in 5 ml spoonful)
+- 1 dose to be taken 6 hours later and then daily for 2 days (in 5 ml spoonful)
+
+1-3 years:
+
+- 3-4 initial dose (in 5 ml spoonful)
+- 1-2 dose to be taken 6 hours later and then daily for 2 days (in 5 ml spoonful)
+
+3-6 years:
+
+- 4-6 initial dose (in 5 ml spoonful)
+- 2-3 dose to be taken 6 hours later and then daily for 2 days (in 5 ml spoonful)
+
+6-9 years :
+
+- 6-9 initial dose (in 5 ml spoonful)
+- 3-5 dose to be taken 6 hours later and then daily for 2 days (in 5 ml spoonful)
+
+
+
Prophylaxis and suppression of Malaria-
+
Adults: 2 tablets taken once a week, on the same day each week, during exposure to risk and continued for 6 weeks after leaving the malarious area.
Children (Syrup): The following doses should be taken once a week, on the same day each week, during exposure to risk and continued for 6 weeks after leaving the malarious area.
+
+- Under 1 year: 1 single dose (in 5 ml spoonful)
+- 1-3 years: 2 single dose (in 5 ml spoonful)
+- 3-6 years: 2-3 single dose (in 5 ml spoonful)
+- 6-9 years: 3-5 single dose (in 5 ml spoonful)
+
+
Children (Tablets): For practical purpose, children over 12 years may be treated as adults and for those below this age, the following proportions may be applied.
+
+- Under 1 year: ⅛ adult dose (¼ tablet)
+- 1-4 years: ¼ adult dose (½ tablet)
+- 4-8 years: ½ adult dose (1 tablet)
+- 8-12 years: ¾ adult dose (1.5 tablet)
+
",,"Concomitant therapy with phenylbutazone predisposes to dermatitis, antagonises effect of neostigmine and pyridostigmine, reduces bioavailability of ampicillin. Cimetidine inhibits metabolism of chloroquine raising plasma levels.
","There is no absolute contraindication to the use of chloroquine.
","Choroquine is well tolerated at the standard dosage regimens, side effects such as headache and gastrointestinal disturbances which may occur are not of a serious nature. Where prolonged high dose is required side effects can be of greater severity and patients may develop skin eruptions, occasional depigmentation or loss of hair, difficulty in accommodation, blurring of vision. Corneal opacities disappear completely when the drug is stopped. Rarely thrombocytopenia, agranulocytosis and aplastic anemia have been reported.
The most serious toxic hazard of prolonged therapy with doses is the occasional development of irreversible retinal damage. For this reason considerable caution is needed in the use of choroquine for long-term high dosage therapy and such use should only be considered when no other drug is available. Defects in visual accommodation may occur on first taking choloquine and patients should be warned regarding driving or operating machinery.
","As with all other drugs, the use of choroquine during pregnancy should be avoided if possible, unless in the case of threatening infections, in the judgment of the physician, when the potential benefit outweighs the risk.
","Caution is necessary when giving choroquine to patients with porphyria who also have hepatic dysfunction or cirrhosis as the drug may precipitate severe constitutional symptoms and an increase in the amount of porphyrins excreted in the urine. This reaction is especially apparent in alcoholics. Patients receiving choloquine continuously at higher dose levels for a period longer than 12 months or at weekly intervals for a period of more than 3 years as prophylactic against malaria (or the consumption exceeds 1.6 g/Kg) should undergo ophthalmic examination at three months interval.
","Amoebic hepatitis: Four tablets daily for two days followed by one tablet twice daily for two or three weeks.
Lupus erythomatosus: One tablet twice daily for one to two weeks followed by a maintenance dose of one tablet daily.
",,,,"Store at room temperature in a dry place, away from light.
",11
+1642,Chlorhexidine hydrochloride + Nystatin,chlorhexidine-hydrochloride-nystatin-1642,https://medex.com.bd/attachments/6s74QyWGgs60nbZXm3pOveLobsf3ey/chlorhexidine-hydrochloride-nystatin-prescribing-information,Chlorhexidine & Chloroxylenol preparations,Tinea corporis (ringworm),"It is used to treat skin infections caused by either fungi and/or bacteria, such as-
+
+- Ringworm
+- Athlete's foot and
+- Infected nappy rash
+
","Chlorhexidine & Chloroxylenol preparations
","Nystatin is a fungistatic and fungicidal antibiotic primarily effective against Candida albicans. Chlorhexidine has activity against a wide range of bacteria. Nystatin is poorly absorbed from the gastrointestinal tract. It is not absorbed through the skin or mucous membranes when applied topically
","Route of administration: Topically
Child: Apply 2-3 times a day, continuing for 7 days after lesions have healed.
Adult: Apply 2-3 times a day, continuing for 7 days after lesions have healed. Or as directed by the physician.
",,"There are no known drug interactions.
","Known hypersensitivity to the active substances, especially in those with a history of possible chlorhexidine-related allergic reactions.
","Common side effects: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash and skin irritation. Rare side effects: Severe allergic reactions, leading to a drop in blood pressure and even to unconsciousness.
","This cream should be administered with caution during the early months of pregnancy.
","For external use only. Avoid contact with eyes. If sensitivity occurs, or if new infection appears, discontinue use and institute alternative therapy. This cream contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, including generalized allergic reactions and anaphylactic shock. This cream should not be administered to Anyone with a potential history of an allergic reaction to a chlorhexidine-containing compound.
",,"This is poorly absorbed from the gastrointestinal tract. In the event of accidental oral ingestion, routine measures such as gastric lavage should be performed as soon as possible after ingestion.
",,,"Store below 30°C temperature & dry place, protected from light. Keep out of the reach of children.
",11
+242,Chlorhexidine Hydrochloride + Cetrimide,chlorhexidine-hydrochloride-cetrimide-242,,Chlorhexidine & Chloroxylenol preparations,Sunburn,"Cetrimide & Chlorhexidine Hydrochloride is indicated in Insect bites, Sunburn, Disinfection, Cuts, Scratches, Blisters, Grazes, Nappy rash, Cracked and itchy skin, Cleansing and irrigating the skin or dirty wounds
","Chlorhexidine & Chloroxylenol preparations
","Cetrimide is a quaternary ammonium antiseptic; it has bactericidal activity against both gram-positive and gram-negative organisms. Chlorhexidine is an antimicrobial agent; it is active against a wide range of gram-negative and gram-positive vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses.
","Adult and children: Apply 2-3 times daily or as directed.
",,"There are no known drug interactions and none well documented.
","Not to be used in the eye, ear, mucous membrane or body cavities.
","Repeated application may lead to skin irritation.
","Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","Prolonged and repeated use may increase risk of hypersensitivity reactions. Blood, soap, cotton or other organic matter may decrease antibacterial efficacy.
",,,,,,9
+239,Chlorhexidine Gluconate + Isopropyl alcohol,chlorhexidine-gluconate-isopropyl-alcohol-239,https://medex.com.bd/attachments/pzUPPlFwKOuENf0F72XFxeEvfVu3jN/chlorhexidine-gluconate-isopropyl-alcohol-prescribing-information,Chlorhexidine & Chloroxylenol preparations,Preoperative hand disinfection,"For the disinfection of clean and intact skin. For pre-operative surgical hand disinfection, hand disinfection on the ward prior to aseptic procedures or after handling contaminated materials. For disinfection of the patients’ skin prior to surgery or other invasive procedures
","Chlorhexidine & Chloroxylenol preparations
","Chlorhexidine is a very potent cationic chemoprophylactic agent that has a broad-spectrum of activity against gm+ve and gm-ve bacteria. It is both bacteriostatic and bactericidal depending on its concentration. The bactericidal effect, which is achieved at high concentrations, is due to the binding of the cationic to negatively charged bacterial cell walls and extramicrobial complexes. Bacteriostatic effect is achieved at low concentrations which causes an alteration of bacterial cell osmotic equilibrium and leakage of potassium and phosphorus.
","Pre-operative surgical hand disinfection: Dispense 5 ml of solution and spread thoroughly over both hands and forearms, rubbing vigorously. When dry apply a further 5 ml and repeat the procedure.
Antiseptic hand disinfection on the ward: Dispense 3 ml of solution and spread thoroughly over the hands and wrists rubbing vigorously until dry.
Disinfection of patients skin: Prior to surgery apply the solution to a sterile swab and rub vigorously over the operation site for a minimum of 2 minutes. Chlorhexidine Gluconate is also used for preparation of the skin prior to invasive procedures such as venepuncture.
",,"Chlorhexidine is incompatible with soaps and other anionic agents. Hypochlorite bleaches may cause brown stains to develop in fabrics which have previously been in contact with chlorhexidine solutions.
","Chlorhexidine Gluconate is contraindicated for persons who have previously shown a hypersensitivity reaction to chlorhexidine. However, such reactions are extremely rare.
","Irritative skin reactions can occasionally occur. Generalised allergic reactions have also been reported but are extremely rare
","No untoward effects are known
","Avoid contact with brain, meninges, middle ear or sensitive tissues and eyes. Do not inject or use in body cavities.
",,"Symptoms: Pharyngeal oedema, necrotic lesions of the esophagus and elevated serum aminotransferase concentrations.
Management: Gastric lavage using milk, raw egg, gelatin or mild soap, or employ appropriate supportive measures.
",,,"Do not store above 25° C.
",11
+241,Chlorhexidine Gluconate + Cetrimide,chlorhexidine-gluconate-cetrimide-241,https://medex.com.bd/attachments/Sb0od0Rf1TiQsIto3rjbSM2TINhU8a/chlorhexidine-gluconate-cetrimide-prescribing-information,Chlorhexidine & Chloroxylenol preparations,Wounds,"For cleansing and irrigating the skin and dirty wounds where an added surfactant effect is required.
","Chlorhexidine & Chloroxylenol preparations
","Chlorhexidine: Chlorhexidine is an antiseptic and disinfectant which is effective against a wide range of vegetative Gram-positive and Gram-negative organisms, some viruses and some fungi. It is ineffective against bacterial spores at room temperature, and acid-fast bacteria are inhibited but not killed. It is more active against Gram-positive than Gram-negative bacteria and some species of Pseudomonas and Proteus are relatively less susceptible. Chlorhexidine is most active at a neutral or slightly acid pH and its activity may be reduced by blood and other organic matter.
Cetrimide: Cetrimide is a quaternary ammonium disinfectant with properties typical of cationic surfactants. Solutions of these surfactants have emulsifying and detergent properties and bactericidal activity against both Gram-positive and Gram-negative organisms but higher concentrations are necessary to kill the latter. The combined detergent and antibacterial properties of cetrimide make it useful in cleansing dirty or infected wounds. It is however, relatively ineffective against bacterial spores, acid-fast bacteria, viruses and fungi.
","Rinse the area to be cleaned with water, apply the minimum amount of irrigation necessary to cover the wound area and wash gently. Rinse again thoroughly. Apply to wound as necessary. Discard remaining solution after use.
Paediatric Use: Use with care in neonates, particularly in premature infants. Chlorhexidine may cause irritation or chemical burns.
",,,"Known hypersensitivity to either chlorhexidine or cetrimide. Do not use to irrigate the brain, meninges, eyes or perforated eardrum.
","Irritative skin reactions and hypersensitivity reactions to chlorhexidine have been reported. In the event that these reactions occur, discontinue use. Cetrimide may have a prolonging effect on the wound healing process.
","Pregnancy: There are no adequate data from the use of chlorhexidine and cetrimide in pregnant women. The potential risk for humans is unknown but is most likely very low since chlorhexidine and cetrimide are poorly absorbed following topical application.
Breastfeeding: It is not known whether chlorhexidine and cetrimide are excreted in breast milk. There are no adequate data from the use of chlorhexidine and cetrimide in breast-feeding women. However, it is unlikely that the products are excreted in breast milk, since the products are poorly absorbed. After topical usage of the product, as a general precaution, rinse nipples thoroughly with water before breastfeeding.
","For external use only. Not for injection, for irrigation only. Not isotonic and is haemolytic. Cetrimide may have a prolonging effect on the wound healing process. Use of this antiseptic should be restricted to infection control and cleansing of wounds rather than general wound management.
",,"While accidental ingestion is unlikely to cause any systemic effects due to poor absorption of chlorhexidine and cetrimide, ingestion of high concentrations could cause irritation of the gastrointestinal mucosa/gastritis. Gastric lavage might be needed. Symptomatic treatment should be employed. If swallowed, wash out mouth, drink plenty of milk or water and seek medical advice. In case of overdose, seek medical attention or contact a poison control centre.
",,,"Store below 25°C. Protect from light. Single use only. Discard unused portion.
",10
+1492,Chlorhexidine Gluconate [7.1%],chlorhexidine-gluconate-71-1492,,Bleaching and Disinfectants,Prophylaxis of omphalitis,"Chlorhexidine Gluconate 7.1% Solution is indicated for prophylaxis of omphalitis (infection of the umbilical cord) in newborn.
","Bleaching and Disinfectants
","Chlorhexidine is a broad-spectrum biocide effective against Gram-positive bacteria, Gramnegative bacteria and fungi. It has both bacteriostatic and bactericidal action, depending on its concentration. Chlorhexidine kills by disrupting the cell membrane. Upon application in vitro, Chlorhexidine can kill nearly 100% of Gram-positive and Gram-negative bacteria within 30 seconds. Since Chlorhexidine formulations can destroy the majority of categories of microbes, there is limited risk for the development of opportunistic infections.
Chlorhexidine is cationic in nature and binds strongly to skin. Data relating to topical administration in neonates are limited. There are no data on metabolism of Chlorhexidine following topical administration.
","Immediately after cutting the cord, 7.1% Chlorhexidine Gluconate should be applied to the tip of the cord, the stump and around the base of the stump.
","Chlorhexidine ব্যবহারের পূর্বে ও পরে হাত ভালো করে সাবান ও পানি দিয়ে ধুয়ে ফেলুন। Chlorhexidine এর ড্রপার বোতল চেপে সলিউশনটি নবজাতকের জন্মের পরপর কাটা নাড়ীর অগ্রভাগ, চারপাশ ও গোড়ায় এমনভাবে লাগান যেন সম্পূর্ণ নাড়ীটি ভালো ভাবে ভিজে যায়। Chlorhexidine লাগানোর পর নাড়ী কোন কিছু দিয়ে মুছবেন না। একবার Chlorhexidine লাগানোর পর নাড়ী শুষ্ক রাখুন ও নাড়ীতে অন্য কোন কিছুই লাগাবেন না। চোখে লাগাবেন না।
",,,,"Not applicable for the intended patient population.
","For external use only. Do not inject or swallow. Keep out of the eyes and ears and do not use over large areas of the body. If the product comes into contact with the eyes, wash out promptly and thoroughly with clean water. There have been reports of hypersensitivity and skin irritation after topical administration of Chlorhexidine, including generalized allergic reactions and anaphylactic shock. The prevalence of Chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be very rare. The application of this product should be discontinued and immediate medical help should be sought in case of any symptoms which may indicate an allergic reaction. If skin irritation or redness occurs, prompt medical advice should be sought.
",,,,,"শিশুদের নাগালের বাইরে রাখুন। আলো থেকে দূরে, ঠাণ্ডা (৩০° সে. এর নিচে) ও শুষ্ক স্থানে রাখুন। কেবলমাত্র রেজিস্টার্ড চিকিৎসকের ব্যবস্থাপত্র অনুযায়ী ব্যবহার্য ও বিক্রয়যোগ্য।
",8
+1494,Chlorhexidine Gluconate [4%],chlorhexidine-gluconate-4-1494,https://medex.com.bd/attachments/ND8bZqwmcIgLnaqWDP8iWjg4GX03dB/chlorhexidine-gluconate-4-prescribing-information,Other antibacterial preparation,Bacterial infections,"Chlorhexidine Gluconate (4%) is indicated in-
+
+- Surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
+- Healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
+- Patient preoperative skin preparation: for the preparation of the patient's skin prior to surgery
+- Skin wound and general skin cleansing.
+
","Other antibacterial preparation
","Chlorhexidine is a very potent cationic chemoprophylactic agent that has a broad-spectrum of activity against gm+ve and gm-ve bacteria. It is both bacteriostatic and bactericidal depending on its concentration. The bactericidal effect, which is achieved at high concentrations, is due to the binding of the cationic to negatively charged bacterial cell walls and extramicrobial complexes. Bacteriostatic effect is achieved at low concentrations which causes an alteration of bacterial cell osmotic equilibrium and leakage of potassium and phosphorus.
","হাত ধোয়ায়: পানিতে হাত ভিজিয়ে নিন। প্রায় ৫ মিলি Chlorhexidine নিয়ে ১ মিনিট ধরে হাত ধুতে থাকুন ; নখের প্রতি বিশেষ মনযোগ দিন। পরিষ্কার পানিতে হাত ধুয়ে ফেলুন ও শুকিয়ে নিন। দ্রুত ব্যাকটেরিয়া বিনাশী ত্বক পরিষ্কারক দ্রবণ, যা শল্য চিকিৎসার পূর্বে হাতকে সংক্রামক জীবাণুমুক্ত করে এবং হাসপাতালের ওয়ার্ডসমূহে নিয়মিত ব্যবহারে বহুমুখী সংক্রামণের ঝুঁকি কমায়।
শল্য চিকিৎসায় অস্ত্রপচার এর পূর্বে হাত ধোয়ায়: পানিতে হাতের কুনুই পর্যন্ত ভিজিয়ে নিন। প্রায় ৫ মিলি Chlorhexidine নিয়ে ১ মিনিট ধরে হাত ধুতে থাকুন; নখ পরিষ্কারের জন্য ব্রাশ বা র্স্ক্যাপার ব্যাবহার করুন। পরিষ্কার পানিতে হাত ধুয়ে ফেলুন। একই পদ্ধতিতে ২ মিনিট ধরে পুনরায় হেক্সিস্ক্রাব ব্যাবহার করুন।
",,,"Do not use
+
+- if you are allergic to chlorhexidine gluconate or any other ingredients
+- in contact with meninges
+- in the genital area
+- as a preoperative skin preparation of the head or face.
+
",,,"শিশুদের নাগালের বাইরে রাখুন। চোখ, মস্তিষ্ক, মেনিঞ্জেস ও মধ্যকর্ণ হতে দূরে রাখুন । চোখের সংপর্শে এলে তাৎক্ষনিকভাবে পর্যাপ্ত পানি দিয়ে চোখ ধুয়ে ফেলুন । আলো থেকে দূরে, ঘরে স্বাভাবিক তাপমাত্রায় রাখুন। ক্লোরহেক্সিডিন সাবান ও অন্যান্য অ্যানায়নিক এর সাথে ইনকমপিটেবল । কেবলমাত্র দেহের বহিরাংশে ব্যাবহারের জন্য ।
",,,,,"Store in a cool and dry place, protected from light.
",7
+1493,Chlorhexidine Gluconate [1%],chlorhexidine-gluconate-1-1493,,Other antibacterial preparation,Topical antiseptic,"It is used as an antiseptic cream and lubricant by healthcare professionals when examining women during pregnancy or for gynecological problems.
","Other antibacterial preparation
","Chlorhexidine is a very potent cationic chemoprophylactic agent that has a broad-spectrum of activity against gm+ve and gm-ve bacteria. It is both bacteriostatic and bactericidal depending on its concentration. The bactericidal effect, which is achieved at high concentrations, is due to the binding of the cationic to negatively charged bacterial cell walls and extramicrobial complexes. Bacteriostatic effect is achieved at low concentrations which causes an alteration of bacterial cell osmotic equilibrium and leakage of potassium and phosphorus.
","Chlorhexidine Gluconate cream is used by healthcare professionals during a physical examination. Some will be spread onto the gloved hand of the examiner and some will be applied around the birth canal and perineum of the patient. This cream is for the use on the skin or vagina only.
",,"Advice of healthcare professional should be sought if using or have recently used any other drugs. Hypochlorite bleaches may cause brown stains to develop in fabrics which have previously been in contact with preparations containing Chlorhexidine.
","Chlorhexidine Gluconate cream is contraindicated for patients who are hypersensitive to Chlorhexidine.
","Allergic reactions like sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (specially affecting the whole body) may occur.
","Chlorhexidine Gluconate cream is safe during pregnancy and lactation.
","Avoid application to the ears and eyes, and any deep cuts involving the head or spine.Wash out with water if necessary. If mixed with soap or detergents its effectiveness may reduce. If swallowed treat symptomatically and with gastric lavage using milk, raw egg, gelatin or mild soap.
",,,,,"Keep in a cool and dry place protected from light. Shake the bottle well before use.
",10
+240,Chlorhexidine Gluconate [0.2%],chlorhexidine-gluconate-02-240,https://medex.com.bd/attachments/fU1DuKf2SnIJE9eALfAWUen3qiLJCN/chlorhexidine-gluconate-02-prescribing-information,Other antibacterial preparation,Surface disinfection,"Chlorhexidine Gluconate Mouthwash is an antimicrobial solution which inhibits the formation of dental plaque. It is indicated as an aid in the treatment and prevention of gingivitis and in the maintenance of oral hygiene, particularly in situations where tooth brushing cannot be adequately employed ... Read more
Chlorhexidine Gluconate Mouthwash is an antimicrobial solution which inhibits the formation of dental plaque. It is indicated as an aid in the treatment and prevention of gingivitis and in the maintenance of oral hygiene, particularly in situations where tooth brushing cannot be adequately employed (e.g. following oral surgery, in mentally or physically handicapped patients). It may also be used in a post-peridontal surgery or treatment regimen to promote gingival healing.
","Other antibacterial preparation
","Chlorhexidine is a very potent cationic chemoprophylactic agent that has a broad-spectrum of activity against gm+ve and gm-ve bacteria. It is both bacteriostatic and bactericidal depending on its concentration. The bactericidal effect, which is achieved at high concentrations, is due to the binding of the cationic to negatively charged bacterial cell walls and extramicrobial complexes. Bacteriostatic effect is achieved at low concentrations which causes an alteration of bacterial cell osmotic equilibrium and leakage of potassium and phosphorus.
","Adults: Thoroughly rinse the mouth for about one minute with 10 ml twice daily. In the dental surgery the patient should be instructed to rinse the mouth for one minute prior to treatment. Chlorhexidine Gluconate is incompatible with anionic agents which are usually present in conventional dentifrices. These should therefore be used before Chlorhexidine Gluconate (rinsing the mouth between applications) or at a different time of day.
For the treatment of gingivitis a course of about one month is advisable although some variation in response is to be expected. In the case of aphthous ulceration and oral candidal infections treatment should be continued for 48 hours after clinical resolution. For the treatment of dental stomatitis the dentures should be cleansed and soaked in Chlorhexidine Gluconate mouthwash for fifteen minutes twice daily.
Children and the Elderly: The normal adult dose is appropriate for elderly patients and children of 12 years and over unless otherwise recommended by the dentist or the physician. Children under 12 years of age should not use the product unless recommended by a healthcare professional. Route of administration: External (oral) use.
",,"Soaps, other anionic agents, borates, bicarbonates, carbonates, chlorides, citrates, nitrates, phosphates & sulfates.
","Hypersensitivity.
","Skin sensitivity; mucosal irritation; reversible brown staining of the teeth; tongue discoloration and burning sensation; transient taste disturbance; parotid gland swelling.
","Pregnancy Category B. Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
","Avoid contact with middle ear or sensitive tissues and eyes. Do not inject or use in body cavities.Avoid eating, drinking, or brushing your teeth just after using this medication
",,,,,"Store in a cool and dry place, protected from light.
",10
+1845,Clascoterone,clascoterone-1845,https://medex.com.bd/attachments/6v5y1PoTKOOLzBcJo9jxid36HKhuh3/clascoterone-prescribing-information,Acne treatment preparations,Acne vulgaris,"Clascoterone cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
","Acne treatment preparations
","Acne is a multifactorial skin condition characterized by excess sebum production, epithelial hyperkeratinization, proliferation of the skin commensal bacteria, and inflammation. Circulating and locally synthesized natural ligands, testosterone and dihydrotestosterone (DHT), serve as causative factors in both males and females. Upon binding of DHT, the DHT-androgen receptor complex dimerizes and translocates to the nucleus where it promotes the transcription of genes involved in acne pathogenesis, including proliferation and differentiation of sebocytes, excess sebum production, and inflammatory cytokine production. Clascoterone is a potent antagonist at ARs and competes for androgens in binding to the receptor, thereby inhibiting downstream signalling of ARs that promote acne.
Androgenetic alopecia is also an androgen-dependent and highly genetic condition. Dihydrotestosterone (DHT) binds to ARs expressed on dermal papilla cells (DPC) in the scalp to induce AR-mediated transcription of genes that contribute to androgenic alopecia. By blocking the interaction between DHT and aARs, clascoterone inhibits AR-regulated transcription and DHT-induced IL-6 synthesis.
","Cleanse the affected area gently. After the skin is dry, apply a thin uniform layer of Clascoterone cream twice per day, in the morning and the evening, to the affected area. Avoid accidental transfer of Clascoterone cream into eyes, mouth or other mucous membranes. If contact with mucous membranes occurs, rinse thoroughly with water. Clascoterone cream is for topical use only. This cream is not for ophthalmic, oral or vaginal use.
",,,,"Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In two identical multicenter, randomized, double-blind, vehicle-controlled trials, 1421 subjects 12 years and older with facial acne vulgaris applied Clascoterone cream or vehicle twice daily for 12 weeks. Overall, 62% of the subjects were female, and 38% were male, 91% of the patients were Caucasian, and the mean age was 19.7 years.
Local skin reactions (edema, erythema/redness, pruritus, scaling/dryness, skin atrophy, stinging/burning, striae rubrea, telangiectasia) were observed during the 12-week treatment and occurred in a similar percentage of subjects treated with vehicle.
","Pregnancy: There are no available data on Clascoterone cream use in pregnant women to evaluate for a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneous administration of clascoterone to pregnant rats and rabbits during organogenesis at doses 8 or 39 times the maximum recommended human dose (MRHD), respectively, increased malformations in rats and post-implantation loss and resorptions in rabbits. The background risk of major birth defects and miscarriage for the indicated population is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Lactation: There are no data regarding the presence of clascoterone or metabolite in human milk, the effects on the breastfed infant or the effects on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of clascoterone to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clascoterone and any potential adverse effects on the breastfed child from clascoterone or from the underlying maternal condition.
","Local Skin Reactions: Clascoterone cream may induce local irritation (erythema/redness, pruritus, scaling/ dryness). Concomitant use with other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect and products with high concentrations of alcohol, astringents, spices or lime) should be limited. The product should not be applied to cuts, abrasions, eczematous or sunburned skin.
Hypothalamic-pituitary-adrenal (HPA) Axis Suppression: Hypothalamic-pituitary-adrenal (HPA) axis suppression was observed and may occur during or after treatment with clascoterone. In the PK trial, all subjects returned to normal HPA axis function at follow-up 4 weeks after stopping treatment. Conditions which augment systemic absorption include use over large surface areas, prolonged use, and the use of occlusive dressings. If HPA axis suppression develops, an attempt should be made to withdraw the drug. Pediatric patients may be more susceptible to systemic toxicity.
","Pediatric Use: Safety and effectiveness of Clascoterone cream for the topical treatment of acne vulgaris have been established in 641 pediatric patients, aged 12 to 18 years in two identical multicenter, randomized, double-blind, vehicle-controlled, 12-week trials and 2 open-label pharmacokinetic studies. Safety and effectiveness of Clascoterone cream for the topical treatment of acne vulgaris has not been established in pediatric patients under 12 years of age.
Geriatric Use: Clinical studies of Clascoterone cream did not include sufficient numbers of subjects aged 65 years of age and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+271,Clarithromycin,clarithromycin-271,https://medex.com.bd/attachments/QxF94JRCkNGaoBS0lATpAEoQF9vEvQ/clarithromycin-tablet-oral-suspension-prescribing-information,Macrolides,Tonsillitis,"Clarithromycin is indicated in-
+
+- Streptococcal pharyngitis
+- Sinusitis
+- Infective exacerbations of chronic bronchitis
+- Community-acquired pneumonia
+- Atypical pneumonia
+- Skin and soft tissue infection
+- Adjunct in the treatment of duodenal ulcers by eradication of H.pylori.
+
","Macrolides
","Clarithromycin acts by inhibiting microsomal protein synthesis in susceptible organisms mainly by binding to the donor site on the 50S subunit of the bacterial ribosome and preventing translocation to that site. Clarithromycin is active against most Gram-positive bacteria and Chlamydia, some Gram-negative bacteria and Mycoplasmas. Clarithromycin's activity is the same as, or greater than, that of Erythromycin in vitro against most Gram-positive bacteria. Clarithromycin is more acid-stable than Erythromycin and therefore, is better tolerated. Clarithromycin has twice the activity of Erythromycin against H. influenzae. Most species of Gram-negative bacteria are resistant to Clarithromycin because of failure to penetrate the target.
","Adults:
+
+- Pharyngitis / Tonsillitis 250 mg every 12 hours for 10 days.
+- Acute maxillary sinusitis 500 mg every 12 hours for 14 days.
+- Chronic bronchitis 250-500 mg every 12 hours for 7-14 days.
+- Pneumonia 250 mg every 12 hours for 7-14 days.
+- Uncomplicated skin & skin structure infections 250 mg every 12 hours for 7-14 days.
+- Community-acquired upper and lower respiratory tract infections 250-500 mg every 12 hours for 5-14 days.
+
+Children:
+
+- Bodyweight under 8 kg: 7.5 mg/kg twice daily.
+- Bodyweight of 8-11 kg (1-2 years): 2.5 ml (Half teaspoonful) twice daily.
+- Bodyweight of 12-19 kg (3-6 years): 5 ml (One teaspoonful) twice daily.
+- Bodyweight of 20-29 kg (7-9 years): 7.5 ml (One & half teaspoonfuls) twice daily.
+- Bodyweight of 30-40 kg (10-12 years): 10 ml (Two teaspoonfuls) twice daily.
+
","Clarithromycin may be given with or without meals.
","Theophylline: Concomitant use of Clarithromycin who are receiving Theophylline may be associated with an increase in serum Theophylline concentrations. Terfenadine: Clarithromycin may alter the metabolism of Terfenadine.
","Hypersensitivity to Clarithromycin, Erythromycin, or any of the macrolide antibiotics. Patients receiving Terfenadine who have pre-existing cardiac abnormalities or electrolyte disturbances.
","Clarithromycin is generally well tolerated. Side effects include nausea, vomiting, diarrhoea and abdominal pain. Stomatitis and glossitis have also been reported. Other side effects include headache, allergic reactions ranging from urticaria and mild skin reactions to anaphylaxis. Taste perversion may occur. There have been reports of transient central nervous system side effects including anxiety, dizziness, insomnia and hallucination.
","The drug may be used in neonates and children in appropriate doses. Breast milk from mothers receiving Clarithromycin should not be given to infants until treatment is completed. There is as yet little experience in the treatment of pregnant patients and Clarithromycin is not recommended.
","Clarithromycin is principally excreted by the liver and kidney. Caution should be taken in administering this antibiotic to patients with impaired hepatic and renal function. Prolonged or repeated use of Clarithromycin may result in an overgrowth of non-susceptible bacteria or fungi. If superinfection occurs, Clarithromycin should be discontinued and appropriate therapy should be instituted.
",,"Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce gastro-intestinal symptoms. One patient who had a history of bipolar disorder ingested 8 grams of clarithromycin and showed altered mental status, paranoid behaviour, hypokalemia and hypoxemia. Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum levels are not expected to be appreciably affected by haemodialysis or peritoneal dialysis.
",,,"Store in a cool and dry place, protected from light & moisture. The reconstituted suspension must be used within 7 days if kept at room temperature and within 14 days when stored in a refrigerator. Keep out of reach of children.
",12
+1441,Citric Acid Monohydrate,citric-acid-monohydrate-1441,,Cough suppressant,Dry cough,"Citric Acid Monohydrate is indicated for the management of dry cough.
","Cough suppressant
","Citric Acid Monohydrate helps to reduce the dry cough and soothes the throat from any related discomfort and pain. Citric Acid is a demulcent which relieves irritation of the mucous membrane in the throat by forming a protective film. Citric Acid is absorbed after oral administration. It is found naturally in the body and is widely distributed.
","1-5 years: 5 ml upto 4 times daily
6-12 years: 10 ml upto 4 times daily
>12 years & Adults: 20 ml upto 3-4 times daily
",,"No drug-drug interaction has been found.
","It is contraindicated for the hypersensitivity to any of the ingredients of this medicine.
","There are no known side effects from using this medicine when used as directed. If taken excessively above the stated dose, glycerol present in the medicine may cause headache, stomach upset and diarrhea.
","There are no or limited amount of data from the use of Citric Acid Monohydrate in pregnant women. There is insufficient information on the excretion of Citric Acid Monohydrate & its metabolites in human milk.
","Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
",,,,,"Keep in a cool and dry place, away from light. Keep out of the reach of children.
",10
+269,Citicoline Sodium,citicoline-sodium-269,https://medex.com.bd/attachments/4T7iLyHwBZ6PWIe8nDHS0P96opab2N/citicoline-sodium-tablets-prescribing-information,CNS stimulant drugs,Parkinson’s disease,"Citicoline Sodium is indicated in-
+
+- Cerebrovascular disease e.g. ischemia due to stroke, where Citicoline accelerates the recovery of consciousness & overcoming motor deficit. Treatment within the first 24 hours after onset in patients with moderate to severe stroke increases the probability of complete recovery in 3 months.
... Read more
Citicoline Sodium is indicated in-
+
+- Cerebrovascular disease e.g. ischemia due to stroke, where Citicoline accelerates the recovery of consciousness & overcoming motor deficit. Treatment within the first 24 hours after onset in patients with moderate to severe stroke increases the probability of complete recovery in 3 months.
+- Cerebral insufficiency (e.g. dizziness, memory loss, poor concentration & disorientation) due to head trauma or brain injury.
+- Cognitive dysfunction due to degenerative disease (Alzheimer's disease)
+- Parkinson's disease: Citicoline has been shown to be effective as co-therapy for Parkinson's disease.
+
","CNS stimulant drugs
","Citicoline is a naturally occurring substance that is an essential intermediate in the synthesis of structural phospholipids of cell membrane. Oral dose of Citicoline is metabolized to choline & cytidine. These then enter into the systemic circulation, cross the blood-brain barrier and recombine to form Citicoline within the central nervous system. Citicoline activates the biosynthesis of structural phospholipids in the neuronal membrane, promotes rapid repair of injured cell surface & mitochondrial membrane & increases the level of various neurotransmitters like acetylcholine & dopamine. Citicoline has neuroprotective effects in situations of hypoxia & ischemia, as well as improved learning & memory performance in animal models for the aging brain. Citicoline inhibits the activation of Phospholipase A2 to prevent apoptotic & necrotic cell death.
","Oral:
+
+- Immediate treatment of stroke due to a clot (ischemic stroke): 500-2000 mg of Citicoline per day, start within 24 hours of stroke.
+- For decline in thinking skills due to stroke: 1000-2000 mg of Citicoline per day.
+- Chronic cerebrovascular disease: 1000 mg daily in divided dose with or between meals for ongoing disease of the blood vessels that serve the brain.
+
+Injection:
+
+- 1 to 2 injections daily.
+- Adjust dosage according to the severity.
+- Can be administered through intramuscular (IM), or intravenous (IV) [ 3 to 5 minutes] route.
+
",,"Citicoline may enhance the effects of levodopa, carbidopa & entacapone. Citicoline must not be administered with products containing meclophenoxate.
","Patients with hypertonic of the parasympathetic nervous system.
","Occasionally Citicoline may exert stimulating action of the parasympathetic system as well as a fleeting & discrete hypotensive effect.
","There are no adequate & well controlled studies of Citicoline during pregnancy & lactation. Citicoline should be used during pregnancy & lactation only if the potential benefits justify the potential risks.
","In case of persistent intracranial hemorrhage, it is recommended not to exceed the dose of 1000 mg of Citicoline daily.
","Geriatric use: No dosage adjustment is required & the usual dose can be administered.
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+268,Citalopram Hydrobromide,citalopram-hydrobromide-268,https://medex.com.bd/attachments/K04nzFiHdgbnKFEbHNOu4OIBfdkJue/citalopram-hydrobromide-prescribing-information,SSRIs & related anti-depressant drugs,Trichotillomania,"Citalopram is indicated for depressive illness and panic disorder. It is also indicated in substance abuse disorders and alcohol dependence. Citalopram has also been given in variety of anxiety disorders including obsessive-compulsive disorder and social phobia. It is also effective in generalized anxiety ... Read more
Citalopram is indicated for depressive illness and panic disorder. It is also indicated in substance abuse disorders and alcohol dependence. Citalopram has also been given in variety of anxiety disorders including obsessive-compulsive disorder and social phobia. It is also effective in generalized anxiety disorder, post-traumatic stress disorder, premenstrual syndrome, idiopathic Parkinson's disease and eating disorder.
","SSRIs & related anti-depressant drugs
","Citalopram is bicyclic phthalane derivative and a selective serotonin re-uptake inhibitor, with little or no effect on noradrenaline, dopamine and GABA re-uptake. The inhibitory activity explains the antidepressant property of citalopram. It has no or very low affinity for 5-HT1AA, 5-HT2A, D1 and D2 receptors, α1, α2, β-adrenergic, histamine H1, muscarinic, cholinergic, benzodiazepine and opioid receptors.
","Depression, Depressive phase of bipolar disorder:
+
+- Adult: Initially, 20 mg/day, increased to max 40 mg/day after at least 1 wk.
+- Child: Contraindicated.
+- Elderly: 10 mg/day. Max: 20 mg/day.
+
+Panic disorder with or without agoraphobia:
+
+- Adult: Initially, 10 mg/day, increased to 20 mg/day after 1 wk.
+- Child: Contraindicated.
+- Elderly: 10 mg/day. Max: 20 mg/day.
+
",,"Ketoconazole, Itraconazole or Macrolide antibiotics and Citalopram co-administration decreases the metabolism of Citalopram. Omeprazole and Citalopram co-administration might decrease the clearance of Citalopram.
","Citalopram should not be used if the patient enters a manic phase. Concomitant use in patients taking MAO inhibitor is contraindicated. Citalopram is contraindicated in patients with a hypersensitivity to this drug or any of its ingredients.
","SSRIs are less sedating and have fewer antimuscarinic and cardiotoxic effects than tricyclic antidepressants. However, side-effects may be seen, includes gastro-intestinal effects (nausea, vomiting, dyspepsia, abdominal pain, diarrhoea, constipation), anorexia with weight loss, palpitations, tachycardia, postural hypotension, cough, confusion, impaired concentration, amnesia, urinary retention, sweating, movement disorders, urticaria, anaphylaxis, arthralgia, myalgia and photosensitivity.
","Pregnancy: There are no adequate and well-controlled studies in pregnant women; therefore, Citalopram should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: Citalopram is excreted in human breast milk. So, the decision whether to continue or discontinue either nursing or Citalopram therapy should take into account the risks of Citalopram exposure for the infants and the benefits of Citalopram treatment for the mother.
","Caution should be taken in patients with epilepsy, concurrent electroconvulsive therapy, history of mania, cardiac disease, diabetes mellitus, angle-closure glaucoma, history of bleeding disorders, hepatic and renal impairment. Abrupt withdrawal of Citalopram should be avoided.
",,"Symptoms: Dizziness, sweating, nausea, vomiting, tremor, somnolence and sinus tachycardia. Rarely, amnesia, confusion, coma, seizures, hyperventilation, cyanosis, rhabdomyolysis and ECG changes (e.g. QT prolongation, sinus bradycardia, ventricular arrhythmias, nodal rhythm, torsade de pointes and left bundle branch block).
Management: Symptomatic and supportive treatment. Maintain and ensure adequate ventilation and oxygenation. Gastric evacuation by lavage and use of activated charcoal should be considered. Frequently monitor cardiac function and vital signs.
",,,"Store at 25° C.
",11
+267,Cisplatin,cisplatin-267,https://medex.com.bd/attachments/eKf0f7zexjH8N4VgLdcfmuuFQk2hj9/cisplatin-prescribing-information,Cytotoxic Chemotherapy,Stomach carcinoma,"Cisplatin is indicated as first line therapy for lung cancer, head & neck cancer and for the treatment of advanced and metastatic ovarian carcinoma, bladder carcinoma and testis carcinoma.
","Cytotoxic Chemotherapy
","Cisplatin modifies cell cycle by interfering with DNA structure and function. Effects are most prominent during the S phase but cells are killed at all stages. Cisplatin synergises with other anticancer drugs e.g. fluorouracil. It has a narrow therapeutic margin and is highly toxic.
","Metastatic ovarian cancer: As monotherapy: 100 mg/m2 per cycle, given as a single dose infused in 0.9% sodium chloride or glucose once every 4 wk. For combination therapy with cyclophosphamide: 75-100 mg/m2 on day 1 of every 4-wk cycle.
Metastatic testicular tumours: 20 mg/m2 BSA daily for 5 days per cycle.
Advanced bladder cancer: 50-70 mg/m2 per cycle once every 3-4 wk, depending on the extent of prior exposure to radiation and/or chemotherapy treatment. An initial dose of 50 mg/m2 every 4 wk may be used in heavily pre-treated patients.
Usual dosage and schedule: 40 to 120 mg/m2 I.V. on day 1 as infusion every 3 weeks. 15 to 20 mg/m2 I.V. on days 1 to 5 as infusion every 3 to 4 weeks. The usual dose in adults and children when used as single agent therapy is 50-100 mg/m2.
",,"Synergistic with 5-fluorouracil and etoposide. Efficacy increased and toxicity reduced when combined with radioprotecting agent WR 2721. At doses ≤100 mg, cisplatin is an ideal drug to combine with other cytotoxic drugs; unlike other antineoplastic drugs, it causes little myelosuppression.
","Cisplatin is contraindicated in patients with pre-existing renal impairment. Cisplatin should not be employed in myelosuppressed patients, or patients with hearing impairment. It is also contraindicated in patients with a history of allergic reactions to cisplatin or other platinum-containing compounds.
","Severe nausea and vomiting. Serious toxic effects on the kidneys, bone marrows and ears. Hypomagnesaemia, hypocalcaemia, hyperuricaemia. Peripheral neuropathies, papilloedema, optic neuritis, seizures. Ototoxicity (children) manifested as tinnitus, loss of hearing, deafness or vestibular toxicity.
","Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Patients with renal or hepatic disorder, myelosuppression. Monitor renal, neurological and auditory function. Perform blood counts regularly. Maintain adequate hydration before and 24 hr after admin to minimise nephrotoxicity.
",,"Acute overdosage may result in kidney failure, liver failure, deafness, ocular toxicity, significant myelosuppression, intractable nausea and vomiting and/or neuritis. Death may also occur following overdosage. Treatment should include general supportive measures.
",,"Cisplatin lyophilized powder for injection 10 mg and 50 mg should be reconstituted with 10 ml and 50 ml of water for inj. respectively.
Cisplatin solution after reconstitution should be added to 2 liters of 5% glucose or 0.9% saline and intravenously administered in 6-8 hours; after administration an adequate hydration and diuresis should be maintained during 24 hours.
","Stability: The cisplatin remaining in vial following initial entry is stable for 28 days protected from light or for 7 days under fluorescent room light.
Storage: Product should be stored at controlled room temperature 25° C and protected from light.
",12
+265,Ciprofloxacin + Hydrocortisone Acetate,ciprofloxacin-hydrocortisone-acetate-265,https://medex.com.bd/attachments/BHTAtXPxMynWELW9mBzD4wJOOoGasF/ciprofloxacin-hydrocortisone-acetate-prescribing-information,Aural steroid & antibiotic combined preparations,Steroid-responsive inflammatory ocular conditions,"This is indicated in Steroid responsive inflammatory ocular conditions, Otitis media, Otitis externa, Ocular inflammation associated with infection, Post-operative inflammation of ear and eye, Corneal Ulcers, Bacterial Conjunctivitis
","Aural steroid & antibiotic combined preparations
","Ciprofloxacin promotes breakage of double-stranded DNA in susceptible organisms and inhibits DNA gyrase, which is essential in reproduction of bacterial DNA.
Hydrocortisone is a corticosteroid used for its anti-inflammatory and immunosuppressive effects. Its anti-inflammatory action is due to the suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. It may also be used as replacement therapy in adrenocortical insufficiency.
","Eye: Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcer is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
Eye: Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.
Ear: Four drops instilled into the affected ear twice daily for seven days. The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the suspension should be instilled. This position should be maintained for 60 seconds. Repeat, if necessary, for the opposite ear.
",,"May increase plasma concentrations of CYP1A2 substrates (e.g. clozapine, ropinirole, theophylline). Enhances effect of oral anticoagulants (e.g. warfarin) and glibenclamide. Increased toxicity of methotrexate. Plasma concentrations may be increased by probenecid. Reduced absorption with oral multivitamins and mineral supplements containing divalent or trivalent cations (e.g. Fe, Zn, Ca) and antacids containing Al, Ca or Mg. Concomitant use with class IA antiarrhythmics (e.g. quinidine, procainamide), class III antiarrhythmics (e.g. amiodarone, sotalol), TCAs, macrolides and antipsychotics may result in additive effects on QT interval prolongation. Concurrent use with corticosteroids may increase risk of severe tendon disorders. Increased risk of CNS stimulation with NSAIDs. Altered serum concentrations of phenytoin.
Potentially Fatal: Marked elevation in serum levels of tizanidine which is associated with potentiated hypotensive and sedative effect.
Thiazides may enhance hyperglycaemia and hypokalaemia caused by corticosteroids. Increased incidence of peptic ulcer or Gl bleeding with concurrent NSAIDs admin. Response to anticoagulants altered. Dose of antidiabetics and antihypertensives needs to be increased. Decreases serum cone of salicylates and antimuscarinic agents. Ethanol may enhance gastric mucosal irritation. Reduced efficacy with concurrent use of carbamazepine, phenytoin, primidone, barbiturates and rifampicin. Mutual inhibition of metabolism between ciclosporin and corticosteroids increase plasma cone of both drugs. Enhanced effect in women taking oestrogens or oral contraceptives.
","Known hypersensitivity to any ingredient of the product. Herpes simplex and other viral conditions, mycosis, glaucoma, newborn babies, fungal diseases of ocular or auricular structures.
","The most frequently reported drug-related adverse reactions seen with Ciprofloxacin are transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness and eye pain. Rare reports of dizziness have been received.
The reactions due to the steroid component are elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior sub-capsular cataract formation and delayed wound healing.
","Pregnancy Category C+D.Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Lactation: Excretion in breast milk unknown; not recommended.
","Prolonged use may result in overgrowth of nonsusceptible organisms including fungi; in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision and posterior sub capsular cataract formation. Patients wearing contact lenses must not use the drops during the time the lenses are worn.
","Paediatric Use:
+
+- Ear: Safety and effectiveness of this suspension in pediatric (6 months of age and older) patients for ear application have been established.
+- Eye: Safety and effectiveness of this suspension in pediatric patients for eye application have not been established.
+
",,,,"Should be stored in cool and dry place.
",11
+264,Ciprofloxacin + Dexamethasone,ciprofloxacin-dexamethasone-264,https://medex.com.bd/attachments/qGO9NyyD8PK8ocMmzZ7qa0KmlIzs9i/ciprofloxacin-dexamethasone-prescribing-information,Aural steroid & antibiotic combined preparations,Steroid-responsive inflammatory ocular conditions,"Eye: This combination eye drop is indicated for the treatment of steroid responsive inflammatory ocular conditions where bacterial infections or risk of bacterial infections co-exist. The use of a combination drug with an anti-infective component is indicated where the risk of infection ... Read more
Eye: This combination eye drop is indicated for the treatment of steroid responsive inflammatory ocular conditions where bacterial infections or risk of bacterial infections co-exist. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The combination can also be used for post-operative inflammation and any other ocular inflammation associated with infection.
Ear: It is indicated for the treatment of ear infections accompanied by inflammation such as otitis externa, otitis media and chronic suppurative otitis media etc. The combination can also be used for post-operative inflammation of ear.
","Aural steroid & antibiotic combined preparations
","Dexamethasone is glucocorticoid. It has an anti-inflammatory and anti-allergic action. It is used topically in the treatment of inflammatory conditions of the anterior segment of the eye. It reduces prostaglandin synthesis by inhibiting the enzyme phospholipase A2. Also, Dexamethasone inhibits the chemotactic infiltration of neutrophils into the site of inflammation.
Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive organisms, possessing the greatest antibacterial activity of all quinolones. The bactericidal action of Ciprofloxacin results from interference with the enzyme DNA gyrase which is needed for the synthesis of bacterial DNA.
","For Eye: 1 drop to be instilled into conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to 1 drop every two hours.
For Ear:
+
+- Acute otitis media in pediatric patients with typanastomy tube: 4 drops instilled into the affected ear 2 times daily for 7 days.
+- Acute otitis externa: 4 drops instilled into the affected ear 2 times daily for 7 days.
+
+Frequency should be decreased gradually or warranted in clinical signs. Care should be taken not to discontinue therapy prematurely.
",,"Specific drug interaction studies have not been conducted with ophthalmic Ciprofloxacin and Dexamethasone. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, enhance the effects of the oral anticoagulant warfarin and its derivatives and have been associated with transient elevations in serum creatinine in patients receiving cyclosporin concomitantly.
","Known hypersensitivity to any ingredient of the product. Herpes simplex and other viral conditions, mycosis, glaucoma, newborn babies, fungal diseases of ocular or auricular structures.
","Frequently reported adverse reactions are transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, photophobia, conjunctivitis/ keratitis, Periocular/ facial edema, foreign body sensation, blurred vision, tearing, dryness, and eye pain. Elevation of IOP with development of glaucoma, and delayed wound healing may rarely occur.
","Use in pregnancy: This should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether topical administration of corticosteroids would result in sufficient systemic absorption to produce detectable quantities in human milk. It is also not known whether ciprofloxacin is excreted in human milk following topical administration. Because many drugs are excreted in human milk, caution should be exercised when the combination is administered to a nursing woman.
","Prolonged use may result in overgrowth of nonsusceptible organisms including fungi; in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision and posterior sub capsular cataract formation. Patients wearing contact lenses must not use the drops during the time the lenses are worn.
","Use in children: Safety & effectiveness for the use of this eye drops in children below the age of one year have not been established.
",,,,"Store in a cool and dry place, away from light. Keep out of reach of children. Shake well before each use.
",11
+266,Ciprofloxacin (Ophthalmic),ciprofloxacin-ophthalmic-266,https://medex.com.bd/attachments/eTgclzOOxWFR0NbKwiV3hGjeaS6M7Y/ciprofloxacin-ophthalmic-prescribing-information,Aural Anti-bacterial preparations,Superficial ophthalmic infections,"Ciprofloxacin 0.3% Eye/Ear Drops is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
+
+- Corneal Ulcers: Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae.
... Read more
Ciprofloxacin 0.3% Eye/Ear Drops is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
+
+- Corneal Ulcers: Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae.
+- Bacterial Conjunctivitis: Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae. It is also indicated in the treatment of keratitis, kerato-conjunctivitis, blepharitis, blepharo-conjunctivitis, dacryocistitis, prophylaxis of ocular infections due to Neisseria gonorrhea or Chlamydia trachomatis, prevention of ocular infections after removal of a corneal or physical agent before or after ocular surgery.
+- Ear: Otitis externa, acute otitis media, chronic suppurative otitis media. Prophylaxis in otic surgeries such as mastoid surgery.
+
","Aural Anti-bacterial preparations, Ophthalmic antibacterial drugs
","Ciprofloxacin is a synthetic broad-spectrum antimicrobial agent for intravenous administration. The bactericidal action of Ciprofloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination.
","Corneal ulcers: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first 6 hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill 2 drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelization has not been occurred.
Bacterial conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.
Ear infections: For all infections, 2-3 drops every 2-3 hours initially, reducing the frequency of the instillation with control of infection. Treatment should be continued at least 7 days.
",,"Specific drug interaction studies have not been observed with ophthalmic Ciprofloxacin.
","Hypersensitivity to quinolone group of antibacterials or any of the components of the formulation.
","Local burning or discomfort, itching, foreign body sensation, crystalline precipitates, lid margin crusting, conjunctival hyperemia and a bad taste following administration. Photophobia and nausea may be reported.
","Do not use unless the potential benefits outweigh the potential risk during pregnancy. It is not known whether excretion in human milk occurs following topical ophthalmic administration. Caution should be exercised in the nursing mothers.
","Prolonged ocular use of Ciprofloxacin may result in overgrowth of non-susceptible organisms, including fungi. Ciprofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction.
","Pediatric use: Safety and effectiveness in children under 1 year of age have not been established.
","A topical overdose may be flushed from the eye/s with warm tap water.
",,,"Store below 30° C in a cool and dry place protected from light. Keep out of reach of children. Do not touch the dropper tip to surfaces since this may contaminate the solution. Do not use after 30 days of first opening.
",12
+263,Ciprofloxacin,ciprofloxacin-263,https://medex.com.bd/attachments/IiNBVhoIMYxnz6YJ0r43BluPHLylgj/ciprofloxacin-tablet-oral-suspension-prescribing-information,Anti-diarrhoeal Antimicrobial drugs,Urinary tract infection,"Ciprofloxacin is indicated for the treatment of Respiratory Tract Infections,Urinary tract infections, Pelvic Inflammatory Diseases, Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera), Typhoid fever, Intra-abdominal infections, Prostatitis, Skin and Soft Tissue Infections, Bone and Joint Infections ... Read more
Ciprofloxacin is indicated for the treatment of Respiratory Tract Infections,Urinary tract infections, Pelvic Inflammatory Diseases, Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera), Typhoid fever, Intra-abdominal infections, Prostatitis, Skin and Soft Tissue Infections, Bone and Joint Infections, Gonorrhea, Neutropenic patients with fever due to bacterial infection, Meningitis, Surgical prophylaxis.
","4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs
","Ciprofloxacin is a synthetic fluoroquinolone. It has bactericidal activity against a wide range of gram-positive and gram-negative organisms. It inhibits bacterial DNA synthesis by binding with the bacterial enzyme-DNA gyrase and topoisomerase IV which are responsible for DNA supercoiling.
","Tablet: Adult:
+
+- Respiratory Tract Infections: 500 to 750 mg twice daily (7 to 14 days)
+- Urinary tract infections: 250 to 750 mg twice daily (3 to 10 days)
+- Pelvic Inflammatory Diseases: 500 to 750 mg twice daily (14 days)
+- Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera): 500 mg twice daily (1 to 5 days)
+- Typhoid fever: 500 mg twice daily (7 days)
+- Intra-abdominal infections: 500 to 750 mg twice daily (5 to 14 days)
+- Prostatitis: 500 to 750 mg twice daily (2 to 6 weeks)
+- Skin and Soft Tissue Infections: 500 to 750 mg twice daily (7 to 14 days)
+- Bone and Joint Infections: 500 to 750 mg twice daily (max. 3 months)
+- Gonorrhea: 500 mg as a single dose
+- Neutropenic patients with fever due to bacterial infection: 500 to 750 mg twice daily co-administered with appropriate antibacterials.
+- Meningitis: 500 mg as a single dose.
+- Surgical prophylaxis: 500 mg as a single dose, 60 minutes before the procedure.
+
+
Suspension: Pediatric: 10-20 mg/kg (max. 750 mg) twice daily (10 to 21 days). The duration of therapy depends on the type and severity of the infection.
Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.
For IV infusion:
+
+- Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days
+- Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
+- Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days
+- Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
+- Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6weeks
+- Intraabdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days
+- Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days
+- Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.
+
","Instruction for the use of Ciprofloxacin IV infusion-
+
+- Check the bag for minute leaks by squeezing the inner bag firmly. If leaks are found, or if seal is not intact, discard the solution.
+- Do not use if the solution is cloudy or a precipitate is present.
+- Do not use flexible bags in series connections.
+- Close flow control clamp of administration set.
+- Remove cover from port at bottom of bag.
+- Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
+- Suspend bag from hanger.
+- Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Ciprofloxacin IV infusion.
+- Open flow control clamp to expel air from set.Close clamp.
+- Regulate rate of administration with flow control clamp
+
+
Duration of treatment: The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings. For acute infections the usual treatment period is 5 to 10 days. Generally treatment should be continued for 3 days after the signs and symptoms of the infection have been disappeared.
","Concurrent administration of Ciprofloxacin should be avoided with Magnesium or Aluminum containing antacids or sucralfate or with other products containing Calcium, Iron or Zinc. These products may be taken two hours after or six hours before Ciprofloxacin. Ciprofloxacin should not be taken concurrently with milk or other dairy products, since absorption of Ciprofloxacin may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the absorption of Ciprofloxacin.
","It is contraindicated in patients who have known hypersensitivity to Ciprofloxacin or other quinolones.
","Side effects include- nausea and other gastrointestinal disturbances, headache, dizziness, joint pain and skin rashes.
","There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and mother. Ciprofloxacin is excreted in human milk. Due to the potential risk of articular damage, Ciprofloxacin should not be used during lactation.
","Patients receiving Ciprofloxacin should be instructed to drink fluids liberally. It should be used with caution in patients with suspected or known CNS disorders such as epilepsy or other factors which predispose to seizures and convulsion. Avoid in patients with known QT prolongation, hypokalemia.
","Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in pediatric population.
","Overdose following Ciprofloxacin administration may lead to seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria, haematuria, & reversible renal toxicity.
",,,"Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.
",13
+1884,Ciprofibrate,ciprofibrate-1884,https://medex.com.bd/attachments/ZXddM2Bqo1GLQG2Z6QlUTU5YFcqpcd/ciprofibrate-prescribing-information,,,"Ciprofbrate is indicated as an adjunct to diet, exercise and weight reduction for the following:
+
+- Treatment of severe hypertriglyceridemia with or without low HDL cholesterol.
+- Mixed hyperlipidemia when a statin is contraindicated or not tolerated.
+
",,"Ciprofbrate reduces both LDL & VLDL and hence the levels of triglyceride and cholesterol associated with these lipoprotein fractions. It also increases levels of HDL cholesterol. Ciprofbrate is effective in the treatment of hyperlipidemia associated with high plasma concentrations of LDL and VLDL. There is evidence that treatment with fibrates may reduce coronary heart disease events.
","Adults: The recommended dose is Ciprofbrate 100 mg per day. This dose should not be exceeded.
Patients with renal insufficiency: In moderate renal impairment (creatinine clearance 30-80 ml/min/1.73 m2) it is recommended that dosage be reduced to one tablet every other day. Patients should be carefully monitored. Ciprofbrate should not be used in severe renal impairment (creatinine clearance <30 ml/min/1.73 m2).
Patients with hepatic insufficiency: Use with caution in patients with impaired hepatic function. Ciprofbrate treatment should be discontinued in case of increased AST and ALT levels to more than 3 times the upper limit of normal or if cholestatic liver injury is evidenced.
Elderly: As for adults but precautions should be taken for Age more than 70 years.
Paediatric population: Not recommended since safety and efficacy in children has not been established.
",,"Other fibrates & HMG CoA reductase inhibitors: As Risk of myopathy, rhabdomyolysis and myoglobinuria may be increased if Ciprofbrate is used in combination with other fibrates and HMG CoA reductase inhibitors.
Oral anticoagulant therapy: Caution should be exercised when Ciprofbrate is taken with oral anticoagulants. Concomitant oral anticoagulant therapy should be given at a reduced dosage and adjusted according to INR.
","
+- Hypersensitivity to the active substance or to any of the excipients
+- Severe hepatic impairment
+- Severe renal impairment (creatinine clearance <30 ml/min/1.73 m2)
+- Pregnancy and lactation or when pregnancy is suspected
+- Concurrent use with another fibrate
+
","Headache, Dizziness, Somnolence, Vertigo, Nausea, Vomiting, Diarrhoea, Dyspepsia, Abdominal pain, Rash, Alopecia, Myalgia, Fatigue.
","There is no evidence that Ciprofbrate is teratogenic but signs of toxicity at high doses were observed in teratogenicity tests in animals. As there are no data on its use in human pregnancy, Ciprofbrate is contraindicated during pregnancy. As there are no data on its use in lactation, Ciprofbrate is contraindicated in nursing mothers.
","Special warnings: Patients with rare hereditary problems of galactose intolerance, lactose deficiency or glucose-galactose malabsorption should not take this medicine.
Myalgia/myopathy: Patients should be advised to report unexplained muscle pain, tenderness or weakness immediately.
Patients with impaired hepatic function: Periodic hepatic function tests are recommended (every 3 months for the first 12 months of treatment). Ciprofbrate treatment should be discontinued in case of increased AST and ALT levels to more than 3 times the upper limit of normal or if cholestatic liver injury is evidenced.
",,,,,"Store below 30°C. Protect from light and moisture. Keep the medicine out of reach of children.
",9
+262,Cinnarizine + Dimenhydrinate,cinnarizine-dimenhydrinate-262,https://medex.com.bd/attachments/WidZzlW5w9Do0KuIlSeNegSoigdevH/cinnarizine-dimenhydrinate-prescribing-information,Anti vertigo drugs,Vertigo,"Cerebral circulatory disorders:
+
+- Prophylaxis and maintenance therapy for symptoms of cerebral vascular spasms and arteriosclerosis such as: dizziness, ear buzzing (tinnitus), vascular headache, unsociability and irritability, fatigue, sleep rhythm disorders such as premature awakening, involutional depressions, loss of memory and lack of concentration, incontinence and other disorders due to aging.
... Read more
Cerebral circulatory disorders:
+
+- Prophylaxis and maintenance therapy for symptoms of cerebral vascular spasms and arteriosclerosis such as: dizziness, ear buzzing (tinnitus), vascular headache, unsociability and irritability, fatigue, sleep rhythm disorders such as premature awakening, involutional depressions, loss of memory and lack of concentration, incontinence and other disorders due to aging.
+- Sequelae of cerebral and cranial trauma.
+- Postapoplectic disorders.
+- Migraine.
+
+
Peripheral circulatory disorders: Prophylaxis and maintenance therapy for symptoms of vascular spasms and arteriosclerosis (obliterating arteritis, thromboangitis obliterans, Raynaud's disease, diabetes, acrocyanosis pernio, etc.) such as intermittent claudication, trophic disturbances, pregangrene, trophic and varicose ulcers, paraesthesia, nocturnal cramps, cold extremities.
Disorders of balance:
+
+- Prophylaxis and maintenance therapy for symptoms of labyrinthine arteriosclerosis; vestibular irritability; Meniere's syndrome such as vertigo, dizziness, giddiness, syncopal attacks, tinnitus, nystagmus, nausea and vomiting.
+- Prophylaxis of motion sickness.
+
","Anti vertigo drugs
","This contains two active ingredients Cinnarizine and Dimenhydrinate. The two substances belong to different groups of medicines. Cinnarizine is part of a group called calcium antagonists. Dimenhydrinate belongs to a group called antihistamines. Both substances work by reducing symptoms of vertigo (a feeling of dizziness or spinning) and nausea (feeling sick). The combination product is more effective than the individual compounds.
","Adults: 1 tablet three times daily, to be taken after meals. Children and
adolescents under the age of 18 years: Not recommended
Elderly: Dosage as for adults.
",,"Concurrent use of alcohol, CNS depressants or tricyclic antidepressants may potentiate the sedative effects of either these drugs or of Cinnarizine and Dimenhydrinate. Therefore, it is advisable to avoid these drugs while taking Cinnarizine and Dimenhydrinate.
","Cinnarizine and Dimenhydrinate should not be used by patients with severe hepatic impairment. Cinnarizine and Dimenhydrinate is contra-indicated in patients with known hypersensitivity to the active substances or to any of the excipients. Cinnarizine and Dimenhydrinate should not be used in patients with angle-closure glaucoma, convulsions, suspicion of raised intracranial pressure, and alcohol abuse or urine retention due to urethroprostatic disorders.
","Drowsiness, dry mouth, headache, and stomach pain may occur. Rare side effects are impaired vision, allergic reactions, light sensitivity, and difficulty in urinating. Other possible reactions which may occur: weight gain, constipation, tightness of the chest, jaundice, worsening of angle-closure glaucoma, uncontrollable movements, unusual excitement and restlessness, severe skin reactions.
","Dimenhydrinate and cinnarizine should not be used during pregnancy and lactation.
","Cinnarizine and Dimenhydrinate do not reduce blood pressure significantly; however, it should be used with caution in hypotensive patients. Cinnarizine and Dimenhydrinate should be taken after meals to minimize any gastric irritation. Caution should be exercised when administering Cinnarizine and Dimenhydrinate to patients with Parkinson’s disease.
",,"Drowsiness, dizziness and ataxia with anticholinergic effects such as dry mouth, flushing of the face, dilated pupils, tachycardia, pyrexia, headache and urinary retention. General supportive measures should be used to treat respiratory insufficiency or circulatory failure. Gastric lavage with isotonic sodium chloride solution is recommended.
",,,"Store in a cool (below 30°C) and dry place. Keep away from light and out of reach of children.
",11
+261,Cinnarizine,cinnarizine-261,https://medex.com.bd/attachments/tL0bauXtVpCyjHxoR67ueVoQf92EUY/cinnarizine-prescribing-information,Anti vertigo drugs,Vertigo,"It is mainly used for the symptomatic treatment of nausea and vertigo due to Meniere's disease and other labyrinthine disturbances and for the prevention and treatment of motion sickness. It is also used in the management of various vascular disorders.
Cerebral circulatory disorders:
... Read more
It is mainly used for the symptomatic treatment of nausea and vertigo due to Meniere's disease and other labyrinthine disturbances and for the prevention and treatment of motion sickness. It is also used in the management of various vascular disorders.
Cerebral circulatory disorders:
+
+- Prophylaxis and maintenance therapy for symptoms of cerebral vascular spasms and arteriosclerosis such as dizziness, ear buzzing (tinnitus), vascular headache, unsociability and irritability, fatigue, sleep rhythm disorders such as premature awakening, involutional depressions, loss of memory and lack of concentration, incontinence and other disorders due to aging.
+- Sequel of cerebral and cranial trauma.
+- Post-apoplectic disorders.
+- Migraine.
+
+
Peripheral circulatory disorders: Prophylaxis and maintenance therapy for symptoms of vascular spasms and arteriosclerosis (obliterating arteritis, thromboangitis obliterans, Raynaud's disease, diabetes, acrocyanosis, perrio, etc.) such as: intermittent claudication, trophic disturbances, pregangrene, trophic and varicose ulcers, paraesthesia, nocturnal cramps, cold extremities.
Disorders of balance:
+
+- Prophylaxis and maintenance therapy for symptoms of labyrinthine arteriosclerosis, vestibular irritability, Meniere's syndrome, such as vertigo, dizziness, giddiness, syncopal attacks, tinnitus, nystagmus, nausea and vomiting.
+- Prophylaxis of motion sickness.
+
","Anti vertigo drugs
","Cinnarizine acts as an antihistamine, labyrinthine sedative and a peripheral antivasoconstrictor. Cinnarizine is a selective calcium antagonist, inhibiting the influx of Ca2+ intracellularly. It prevents the Ca2+ dependent contraction of arterial smooth muscle by inhibiting Ca2+ influx through smooth muscle calcium channels and thereby, improves vestibular symptoms and prevents peripheral arterial disease
","Usual adult dose: 15 to 30 mg three times daily.
Children (5 to 12 years): Half of the adult dose.
Motion sickness: A dose of 30 mg two hours before the start of the journey and 15 mg every 8 hours during the journey.
Peripheral arterial diseases: 75 mg two or three times daily.
",,"No drug interactions have been seen with Cinnarizine when administered concomitantly with antihypertensives, diuretics, anticoagulants or hypoglycaemics.
","There are no specific contraindications. It has been found to decrease blood pressure significantly. However, the drug should be used with reasonable caution in hypotensive patients.
","Side effects such as somnolence and gastrointestinal disturbances are extremely rare. They are transient and may be readily prevented by achieving the optimal dosage gradually. Allergic skin reactions and fatigue have been reported on rare occasions. An aggravation or appearance of extrapyramidal symptoms has been reported extremely rarely in elderly people during prolonged therapy. The treatment should be reduced or stopped in such cases.
","The safety of Cinnarizine in human pregnancy has not been established although studies in animals have not demonstrated teratogenic effects. Therefore, it is not advisable to administer Cinnarizine in pregnancy
","Cinnarizine may cause drowsiness; patients affected in this way should not drive or operate machinery. Avoid alcoholic drink.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+260,Cinchocaine Hydrochloride,cinchocaine-hydrochloride-260,https://medex.com.bd/attachments/DUA5wF9iYNJdqAt1qKw5LBjwRGZOsI/cinchocaine-hydrochloride-prescribing-information,Local & Surface anesthesia,Surface anaesthesia,"Cinchocaine is indicated for Surface anaesthesia, Haemorrhoids
","Local & Surface anesthesia
","Cinchocaine prevents or diminishes nerve impulse conduction near to the site of admin. It also has membrane-stabilising effect owing to decrease of permeability of the nerve cell to sodium ions.
","Surface anesthesia: Use up to 1% cream or ointment topically for adult or as directed by physician
",,,"Complete heart block; pyogenic infection at or near the skin. Application to inflamed or infected tissues or to damaged skin mucosa; instillation into the middle ear.
","Restlessness; excitement; nervousness; paraesthesias; dizziness; tinnitus; blurred vision; nausea; vomiting; muscle twitching; tremors; convulsions; hypotension; bradycardia; arrhythmias; cardiac arrest.
","Pregnancy Category A. A number of epidemiological studies suggest that there could possibly be an increased risk of oral clefts among newborns of women who were treated with systemic glucocorticosteroids during the first trimester of pregnancy. As a general rule, topical preparations containing corticoids should not be applied during the first trimester of pregnancy.
Lactation: The excretion of effective amounts of glucocorticoid with the breast milk is improbable.
","Elderly; debilitated patients; child; epilepsy; impaired cardiac conduction or respiratory function; shock; hepatic impairment; myasthenia gravis. Do not to rub or touch the eye while anaesthesia persists. Avoid application for prolonged periods and to extensive areas. Pregnancy, lactation.
",,,,,"Store below 25°C.
",9
+1224,Cinchocaine + Hydrocortisone + Neomycin + Esculin,cinchocaine-hydrocortisone-neomycin-esculin-1224,,Compound steroidal preparations,Pruritus ani,"This is indicated for-
+
+- Internal and external hemorrhoids
+- Post-partum hemorrhoidal condition
+- Anal pruritus, peri-anal eczema, anal fissures and proctitis
+- Post-hemorrhoidectomy application to relieve pain and discomfort
+
","Compound steroidal preparations, Drugs used in Ano-rectal region
","Cinchocaine is a local anesthetic which relieves severe pain and relaxes sphincteric spasm. Hydrocortisone acts as an anti-inflammatory and anti-pruritic agent and thereby eliminates itching and inflammation. Neomycin is a broad-spectrum antibiotic which eradicates most infections which may already be present or arise in lesions of the anorectal area. Esculin improves skin vasculature and is effective in management of cellulitis.
","Ointment: A small quantity of the ointment should be applied with finger in the painful pruritic area in the morning and evening and after each stool. For deep application nozzle should be attached to the tube and inserted to full extent and should be squeezed gently from the lower end while withdrawing.
Suppository: One suppository in the morning and one in the evening, and one after each stool.
Use in children: Not recommended for children.
",,,"Contraindicated in patients hypersensitive to any component of the product.
","Side effects which have been reported for individual constituents may occur and appropriate precautions should be taken when using this preparation.
","Use in pregnancy: The safe use of topical corticosteroids during pregnancy has not been fully established.
","Like most of the steroids under certain circumstances hydrocortisone may be absorbed in sufficient amount to produce systemic effects. So, long term use should be avoided. Adrenal suppression may occur even without occlusion. When used for prolonged period striae may occur. Skin sensitisation may occur due to Neomycin. Absorption of the antibiotic from wound or inflamed skin may occur and this may affect the hearing irreversibly. Hence this preparation should not be given to extensively damaged skin.
",,,,,"Keep in a cool dry place protected from light. Keep out of reach of children.
",9
+259,Cinchocaine + Hydrocortisone + Framycetin + Esculin,cinchocaine-hydrocortisone-framycetin-esculin-259,https://medex.com.bd/attachments/ED9LsTBw6rjbrRmYj3SlUpPTs0jDjI/cinchocaine-hydrocortisone-framycetin-esculin-prescribing-information,Compound steroidal preparations,Pruritus ani,"This is indicated for the treatment of-
+
+- Internal and external haemorrhoids
+- Haemorrhoids post-partum
+- Anal pruritus, peri-anal eczema, anal fissures and proctitis
+- Post-haemorrhoidectomy application to relieve pain and discomfort
+
","Compound steroidal preparations, Drugs used in Ano-rectal region
","The local anaesthetic Cinchocaine Hydrochloride prevents or relieves the severe pain sometimes encountered in strangulated haemorrhoids, fissures and perianal haematomata, whilst the corticosteroid (Hydrocortisone) acts as a decongestant, anti-inflammatory and anti-pruritic agent and by so doing eliminates itching, inflammation and mucous discharge. The broad spectrum antibiotic, Framycetin Sulphate, will eradicate most infections which may already be present or arise in lesions of the anorectal area and Esculin has a skin protective action.
","Ointment: Apply the ointment in a small quantity with the finger, on the painful or pruritic area, morning and evening and after each stool. For deep application, insert the cannula or applicator to full extent and squeeze tube gently from lower end whilst withdrawing.
Suppository: A suppository is inserted morning and evening, and after each stool.
",,,"Known hypersensitivity to any of the four ingredients. Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously, teratogenicity following topical application cannot be excluded. Therefore this product should not be used during pregnancy. Topical corticosteroid preparations are contraindicated in the treatment of herpes simplex, vaccinia or varicella, or tuberculous infection of the anal region.
","Long-term continuous treatment with topical corticosteroids should be avoided as far as possible as this may cause atrophic changes in the skin leading to thinning, loss of elasticity, dilatation of superficial blood vessels, telangiectasia and ecchymoses. These changes are particularly likely to occur when occlusive dressings are used. Systemic absorption of topically applied corticosteroids may occur, particularly under the following conditions: when large quantities are used or when application is made to wide areas of the body, or to damaged skin; when potent topical corticosteroids are used, and when the occlusive dressing technique is applied. Depression of the hypothalamic-pituitary-adrenal axis with consequent suppression of the adrenal gland may occur. These effects are most likely to be severe in children. Growth may be retarded and a Cushingoid state may be produced. Benign intracranial hypertension has been rarely reported.
","The safe use of topical corticosteroids during pregnancy has not been fully established. Therefore, during pregnancy, they should not be used unnecessarily on extended areas, in large amounts or for prolonged periods of time.
","Discontinue use if sensitization occurs. Other specific measures against infections, allergy, and other causal factors must not be neglected. The possibility, however rare, that prolonged use of this preparation might produce systemic corticosteroid effects, should be borne in mind. Patients should be advised to inform subsequent physicians of the previous use of hydrocortisone.
","Not recommended for use in children.
",,,,"Store at a cool and dry place, protected from light. Store below 25° C. Do not freeze.
",10
+258,Cinacalcet,cinacalcet-258,https://medex.com.bd/attachments/keoA1PkvbgO4KKdl7SCVPeS1uQvIdZ/cinacalcet-prescribing-information,Calcium Regulator,Secondary hyperparathyroidism,"Cinacalcet is indicated in-
+
+- For the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis
+- For the treatment of hypercalcemia in patients with parathyroid carcinoma
+- For the treatment of hypercalcaemia in patients with primary hyperparathyroidism who still have high calcium level after removal of the parathyroid gland
+
","Calcium Regulator
","Cinacalcet is a calcimimetic agent. It lowers parathyroid hormone (PTH) secretion by increasing the sensitivity of the calcium-sensing receptor of the parathyroid gland to activation by extracellular calcium. PTH reduction leads to concomitant decrease in serum calcium and phosphorus concentrations.
","Hypercalcaemia associated with parathyroid carcinoma or primary hyperparathyroidism: ≥18 yr, initial: 30 mg bid. Titrate dose every 2-4 wk in sequential doses of 60 mg bid, 90 mg bid, and 90 mg 3-4 times daily as needed until serum calcium levels normalised. Max: 90 mg 4 times/day.
Secondary hyperparathyroisim in patients with chronic kidney disease on dialysis: ≥18 yr, initial: 30 mg once daily. Titrate dose every 2-4 wk in steps of 30 mg as necessary to achieve intact parathyroid hormone (iPTH) levels of 150-300 pg/mL. Max: 180 mg once daily. May be used alone or in combination with vitamin D sterols and/or phosphate binders.
",,"Cinacalcet is a strong CYP2D6 inhibitor and may increase serum concentrations of amitriptyline, nortriptyline and desipramine. Cinacalcet may decrease serum concentrations of tacrolimus. CYP3A4 inhibitors such as ketoconazole, erythromycin may increase plasma concentrations of Cinacalcet.
","Cinacalcet is contraindicated in patients with hypersensitivity to any components of this product.
","The common side effects of Cinacalcet are nausea, vomiting, anorexia; dizziness, paraesthesia, asthenia; reduced testosterone concentrations; myalgia; rash; less commonly dyspepsia, diarrhoea, and seizures; hypotension and heart failure also reported.
","There are no adequate and well-controlled studies in pregnant women. Cinacalcet should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It Only for the use of Medical Professionals is not known whether this drug is excreted in human milk. Considering the potential for clinically significant adverse reactions in infants from Cinacalcet; it is recommended that breast-feeding be discontinued during treatment with Cinacalcet.
","Cinacalcet treatment should not be initiated if serum calcium is less than the lower limit of the normal range (8.4 mg/dL). Serum-calcium concentration should be measured before initiation of treatment and within 1 week after starting treatment or adjusting dose, then monthly for secondary hyperparathyroidism and every 2–3 months for primary hyperparathyroidism and parathyroid carcinoma; treatment should not be initiated in patients with hypocalcaemia; in secondary hyperparathyroidism PTH concentration should be measured 1–4 weeks after starting treatment or adjusting dose, then every 1–3 months; dose adjustment may be necessary if smoking started or stopped during treatment; hepatic impairment; pregnancy.
","Pediatric use: The safety and efficacy of Cinacalcet in pediatric patients have not been established
Geriatric Use: No dosage adjustment is required for geriatric patients over 65 years of age.
Patients with renal impairment: No dosage adjustment is necessary for renal impaired patients
Patients with hepatic impairment: In patients with moderate and severe hepatic impairment, PTH and serum calcium concentrations should be closely monitored throughout treatment with Cinacalcet.
","Overdosage may lead to hypocalcaemia. Provide treatment to correct serum calcium levels. Haemodialysis are unlikely to be useful.
",,,"Store in a cool dry place below 30ºC. Protect from light
",12
+256,Cilostazol,cilostazol-256,https://medex.com.bd/attachments/LLfbZ9VRpaTPmmFAAwoSRQ28UUJgFD/cilostazol-prescribing-information,Peripheral Vasodilator drugs: Intermittent Claudication,Intermittent angioneurotic dysbasia,"Cilostazol is indicated for the reduction of symptoms of intermittent claudication, as indicated by an increased walking distance.
","Peripheral Vasodilator drugs: Intermittent Claudication
","Cilostazol is a preparation of Cilostazol which is a quinolinone derivative. The mechanism of action is to specifically inhibit cellular phosphodiesterase III (PDE III) and suppress cAMP degradation with a resultant increase in cAMP in platelets and blood vessels, leading to inhibition of platelet aggregation and vasodilation.
","The recommended dosage of Cilostazol is 100 mg bid, taken at least half an hour before or two hours after breakfast and dinner. A dose of 50 mg bid should be considered during coadministration of Fluconazole, Ketoconazole, Itraconazole, Erythromycin, Clarithromycin, Fluvoxamine, Fluoxetine, Nefazodone, Sertraline and Diltiazem.
Pediatric use: The safety and effectiveness of Cilostazol in pediatric patients have not been established.
",,"Pharmacokinetic studies have demonstrated that Omeprazole and Erythromycin significantly increased the systemic exposure of Cilostazol and/or its major metabolites. Population pharmacokinetic studies showed higher concentrations of Cilostazol among patients concurrently treated with Diltiazem.
","Cilostazol is contraindicated in patients with congestive heart failure of any severity. Cilostazol is also contraindicated in patients with known or suspected hypersensitivity to any of its components.
","The most common side effects are headache, diarrhoea, vomiting, leg cramps, rash etc. The less frequent side effects are anorexia and edema.
","There are no adequate and well controlled studies in pregnant women. Transfer of Cilostazol into milk has been reported in experimental animals. Because of the potential risk to nursing infants, a decision should be made to discontinue nursing or to discontinue Cilostazol.
","Cilostazol should be used with caution in patients with any degree of heart failure. There is no information with respect to the efficacy or safety of the concurrent use of Cilostazol and Clopidogrel.
",,,,,"Store in a cool & dry place, protected from light and moisture.
",10
+1377,Cilnidipine,cilnidipine-1377,https://medex.com.bd/attachments/VDp17c5KT0n9PYF05PmoH6790gUHrs/cilnidipine-prescribing-information,Calcium-channel blockers,Hypertension,"Cilnidipine is indicated for the management of hypertension for end-organ protection. It is reported to be useful in elderly patients and in those with diabetes and albuminuria. Cilnidipine has been increasingly used in patients with chronic kidney disease
Hypertension is the term used to ... Read more
Cilnidipine is indicated for the management of hypertension for end-organ protection. It is reported to be useful in elderly patients and in those with diabetes and albuminuria. Cilnidipine has been increasingly used in patients with chronic kidney disease
Hypertension is the term used to describe the presence of high blood pressure. The blood pressure is generated by the force of the blood pumped from the heart against the blood vessels. Thus hypertension is caused when there is too much pressure on the blood vessels and this effect can damage the blood vessel
","Calcium-channel blockers
","Cilnidipine is a dihydropyridine calcium-channel blocker. Cilnidipine binds to the dihydropy-ridine binding sites of the L-type voltage dependent calcium channel and inhibits Ca2+ influx across the cell membranes of vascular smooth muscle cells via this channel, consequently vascular smooth muscle is relaxed, causing vasodilation. Cilnidipine inhibits Ca2+ influx via N-type voltage dependent calcium channels in the sympathetic nerve cell membrane. The inhibition of Ca2+ influx via N-type voltage dependent calcium channel was observed over a similar range of drug concentrations to those inhibiting L-type voltage dependent Ca2+ channels. Consequently, release of norepinephrine from sympathetic nerve terminals would be inhibited. Cilnidipine is considered to suppress the reflex increase in heart rate after blood pressure reduction.
","Adults: 5-10 mg once daily after breakfast. Maximum dose: 20 mg once daily.
Pediatric use: The safety of Cilnidipine in pediatric patients has not been established.
Elderly use: Since the elderly may be more susceptible to hypotension, therapy should be initiated with the lowest possible dose (5 mg).
",,"Other anti-hypertensive, antipsychotics that cause hypotension, quinidine, carbamazepine, phenytoin, rifampicin, cimetidine, erythromycin.
","Cilnidipine is contraindicated in patients with known sensitivity to Cilnidipine or any of the excipients or patients having cardiogenic shock, recent MI or acute unstable angina and severe aortic stenosis.
","The most common side effects of Cilnidipine are: Dizziness; flushing; headache; hypotension; peripheral oedema; palpitations; GI disturbances; increased micturition frequency; lethargy; eye pain; depression.
","Cilnidipine should not be administered in pregnant woman or woman having possibilities of being pregnant. It is also advisable to avoid the administration of Cilnidipine to nursing mothers. However, if the administration is indispensable, the patient should be instructed to discontinue lactation.
","Cilnidipine should be administered with care in the following patients: patients with serious hepatic dysfunction, patients with a history of serious adverse reactions to calcium antagonists. During the discontinuation, the dosage should be gradually decreased under close observation.
",,,,,"Store below 30°C, protected from light and moisture. Keep away from reach out of the children.
",10
+1667,Ciclopirox Olamine (Shampoo),ciclopirox-olamine-shampoo-1667,https://medex.com.bd/attachments/NPNTEiURtWRXzt0uzlNmZyg9NK0qkh/ciclopirox-olamine-shampoo-prescribing-information,Topical Antifungal preparations,Seborrheic dermatitis of the scalp,"Shampoo is indicated in the treatment of Seborrheic dermatitis, Dandruff, Inflammation and Swelling of the scalp.
","Topical Antifungal preparations
","Ciclopirox Olamine is a synthetic broad spectrum antifungal agent that inhibits the growth of pathogenic dermatophytes, yeasts, and Malassezia furfur. Ciclopirox Olamine exhibits fungicidal activity in-vitro against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, and Candida albicans. The mode of action of Ciclopirox Olamine was studied mainly in Candida albicans. It is presumed that Ciclopirox Olamine mediated growth inhibition or death of fungal cells is primarily caused by in-vitro cellular depletion of some essential substrates and/or ions and that such effects are brought about through blockage of their uptake from the medium. In addition to its broad spectrum of antifungal action, Ciclopirox also exerts antibacterial activity against many Gram-positive and Gram-negative bacteria. The anti-inflammatory effects of Ciclopirox have been demonstrated in human polymorphonuclear cells, where Ciclopirox has inhibited the synthesis of prostaglandin and leukotriene. Ciclopirox can also exhibit its anti-inflammatory effects by inhibiting the formation of 5-lipoxygenase and cyclooxygenase.
","Wet hair and apply approximately 1 teaspoon (5 ml) of Ciclopirox Olamine Shampoo to the scalp. Up to 2 teaspoons (10 ml) may be used for long hair. Lather and leave on hair and scalp for 3 minutes. A timer may be used. Avoid contact with eyes. Treatment should be repeated twice per week for 4 weeks, with a minimum of 3 days between applications.
",,,"This Shampoo is contraindicated in individuals who have shown hypersensitivity to any of its components.
","Ciclopirox Olamine Shampoo is well tolerated with a low incidence of adverse reactions reported in clinical trials.
","Pregnancy category B. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ciclopirox Olamine Shampoo or is administered to nursing women.
","Ciclopirox Olamine Shampoo is not for ophthalmic, oral, or intravaginal use.
","No clinical trials have been conducted in subjects younger than 16 years.
",,,,"Keep away from light and moisture. Store below 30°C. Keep out of the reach of children.
",10
+295,Clostridium Botulinum Toxin Type A Neurotoxin,clostridium-botulinum-toxin-type-a-neurotoxin-295,https://medex.com.bd/attachments/ClaMphPEun910bB9a84ny5vswZVKya/clostridium-botulinum-toxin-type-a-neurotoxin-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Strabismus,"This is indicated in Muscle spasm, Strabismus, Blepharospasm, Achalasia, Cervical dystonia, Limb spasticity, Overactive bladder, Chronic migraine, Severe Primary Axillary Hyperhidrosis, Glabellar and lateral Canthal lines (cosmetic purpose).
","Drugs used in Cerebral Palsy, Vaccines, Anti-sera & Immunoglobulin
","Neurotoxin from Clostridium botulinum; prevents ACh release from presynaptic membrane, causing temporary calming of muscle contractions by blocking the transmission of nerve impulses.
Botulinum Toxin Type A blocks the signals between the nerve & its muscle. When this happens a lot of the limb tightness disappears which in tum, allows the muscle a better chance to grow normally. Just as important, Botulinum Toxin Type A therapy can put off surgery a little longer. By encouraging normal movement, child's body is given the chance to grow.
","Glabellar lines: Inject 4 units (0.1 ml) into each of 5 sites, 2 in each corrugator muscle and 1 in procerus muscle for a total dose of 20 units
Canthal lines: Inject 4 units (0.1 ml) into 3 sites per side (6 total injection points) in the lateral orbicularis oculi muscle for a total of 24 units/0.6 ml (12 units per side)
Duration of activity is approximately 3-4 months. More frequent dosing not recommended.
Blepharospasm: 1.25- 2.5 units IM; not to exceed 200 units in 30 days.
Strabismus: 1.25- 5 units IM; <25 units per injection.
Chronic Migraine: Recommended total dose 155 units, as 0.1 ml (5 units) IM injections per each site divided across 7 head/neck muscles q12wk.
Overactive Bladder: Indicated for adults with overactive bladder symptoms (urge incontinence, urgency, frequency) who cannot use or do not adequately respond to anticholinergic medication.
100 units (divided into 20 intradetrusor injections of 5 units each) administered using cystoscopy.
",,"There are no known drug interactions and none well documented.
","As with other immunoglobulin preparations, it should not be used in individuals with a prior history of severe reaction to other human immunoglobulin preparations. Individuals with selective immunoglobulin A deficiency have the potential for developing antibodies to immunoglobulin A and could have anaphylactic reactions to the subsequent administration of blood products that contain immunoglobulin A.
","Serious adverse reactions were not observed in clinical trials. The most common adverse reaction was skin rash. Other reactions such as chills, muscle cramps, back pain, fever, nausea, vomiting, and wheezing were the most frequent adverse reactions observed during the clinical trials of similarly-prepared human IGIV products.
","Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","Patient Monitoring for Administration Patients should be well hydrated prior to the initiation. Assess renal function, including the measurement of blood urea nitrogen (BUN) or serum creatinine prior to the initial infusion. Periodic monitoring of renal function tests and urine output is particularly important in patients judged to have a potential risk for developing acute renal failure. Increases in serum creatinine and BUN have been observed as soon as one to two days following treatment with other IGIV products. During administration, monitor the patient's vital signs continuously and observe the patient carefully for any associated symptoms.
",,,,,,9
+286,Clopidogrel Bisulphate,clopidogrel-bisulphate-286,https://medex.com.bd/attachments/wQGODqTZHqpiIplcy7aoKRdYt7wrjH/clopidogrel-bisulphate-prescribing-information,Anti-platelet drugs,Unstable angina,"Acute Coronary Syndrome (ACS): It is indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)]. It is indicated to reduce the rate of myocardial infarction ... Read more
Acute Coronary Syndrome (ACS): It is indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)]. It is indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI).
Recent MI, recent Stroke, or established Peripheral Arterial Disease: In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke it is indicated to reduce the rate of MI and stroke.
","Anti-platelet drugs
","Clopidogrel is a prodrug. It inhibits platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Dose-dependent inhibition of platelet aggregation can be seen 2 hours after single oral doses. Repeated doses of 75 mg per day inhibit ADP-induced platelet aggregation on the first day, and inhibition reaches steady state between Day 3 and Day 7.
","Acute Coronary Syndrome: In patients who need an antiplatelet effect within hours, initiate clopidogrel with a single 300 mg (4 tablets) oral loading dose and then continue at 75 mg once daily. Initiating it without a loading dose will delay establishment of an antiplatelet effect by several days.
Recent MI, Recent Stroke, or Established Peripheral Arterial Disease: 75 mg once daily orally without a loading dose.
It is given orally with or without food.
",,"
+- NSAIDs, warfarin, selective serotonin and serotonin norepinephrine reuptake inhibitors (SSRIs, SNRIs): Increases risk of bleeding
+- CYP2C19 inhibitors (omeprazole or esomeprazole): Avoid concomitant use of omeprazole or esomeprazole
+- Repaglinide (CYP2C8 substrates): Avoid concomitant use of Clopidogrel with Repaglinide as it increases plasma concentrations of Repaglinide
+
","Clopidogrel is contraindicated in the following conditions: Hypersensitivity to the drug substance or any component of the product. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
","Clopidogrel is generally well tolerated drug.
+
+- Common side effects: Bleeding, Diarrhoea, gastrointestinal discomfort, haemorrhage, Skin reactions.
+- Rare side effects: Acquired haemophilia, anaemia, angioedema, arthralgia, arthritis, bone marrow disorders.
+
","There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed. It is unknown whether clopidogrel is excreted in human breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","
+- As it is a prodrug, so metabolism to its active metabolite is impaired by genetic variations in CYP2C19 (poor metabolizer) and by the drugs that inhibit CYP2C19 such as Omeprazole and Esomeprazole. Concomitant use with these drugs and in CYP2C19 poor metaboliser may reduce the antiplatelet activity of Clopidogrel.
+- As it inhibits platelet aggregation for the lifetime of the platelet (7-10 days), risk of bleeding may increase. To restore hemostasis, platelet transfusions within 4 hours of the loading dose or 2 hours of the maintenance dose may be less effective.
+- Discontinuation of Clopidogrel increases the risk of cardiovascular events. Discontinue 5 days prior to elective surgery that has a major risk of bleeding. Resume Clopidogrel as soon as hemostasis is achieved.
+- Thrombotic Thrombocytopenic Purpura (TTP) has been reported that requires urgent treatment including plasmapheresis (plasma exchange).
+- Hypersensitivity including rash, angioedema or hematologic reaction has been reported in patients receiving clopidogrel or history of hypersensitivity to other thienopyridines.
+
","Safety and effectiveness in pediatric populations have not been established. No dosage adjustment is necessary in elderly patients.
","Overdose following clopidogrel administration may lead to bleeding complications. Based on biological plausibility, platelet transfusion may restore clotting ability.
",,,"Keep below 30°C temperature in a dry place. Protected from light. Do not freeze. Keep out of the reach of children.
",12
+86,Clopidogrel + Aspirin,clopidogrel-aspirin-86,,Anti-platelet drugs,Transient ischemic attack,"Acute Coronary Syndrome (ACS): It is indicated to reduce the rate of Myocardial Infarction (MI) and Stroke in patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation Myocardial Infarction (NSTEMI)] and acute ST-segment elevation ACS [ST-elevation Myocardial ... Read more
Acute Coronary Syndrome (ACS): It is indicated to reduce the rate of Myocardial Infarction (MI) and Stroke in patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation Myocardial Infarction (NSTEMI)] and acute ST-segment elevation ACS [ST-elevation Myocardial Infarction (STEMI)].
Recent MI, recent Stroke, or established Peripheral Arterial Disease: In patients with established peripheral arterial disease or with a history of recent Myocardial Infarction (MI) or recent Stroke it is indicated to reduce the rate of MI and Stroke.
","Anti-platelet drugs
","Clopidogrel is a prodrug. It inhibits platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Dose-dependent inhibition of platelet aggregation can be seen at 2 hours after single oral doses. Repeated doses of 75 mg per day inhibit ADP-induced platelet aggregation on the first day, and inhibition reaches steady state between Day 3 and Day 7.
Aspirin inhibits platelet aggregation by irreversible inhibition of platelet cyclooxygenase and thus inhibiting the generation of thromboxane A2 a powerful inducer of platelet aggregation and vasoconstriction.
","The recommended oral dose is one tablet daily.
",,"Oral anticoagulants, NSAIDs, Metamizole, SSRIs, CYP2C19 inhibitors increase the risk of bleeding. It shows interaction with Tonofovir, Valproic acid, Varicella vaccine, Acetazolamide and Nicorandil.
","This combination is contraindicated in the following conditions: Hypersensitivity to the drug substance or any component of the product. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
","This combination is generally well tolerated.
","There are no adequate and well-controlled studies in pregnant women. It should be used during first and second trimesters of pregnancy only if clearly needed. It is contraindicated during the third trimester of pregnancy. It is unknown whether Clopidogrel is excreted in human breast milk but Aspirin is known to be excreted in human milk. This Drug should be discontinued during the breast feeding.
","
+- This combination may prolongs the bleeding time.
+- Thrombotic thrombocytopenic purpura (TTP): TTP has been reported rarely following use of this combination.
+- Reye's syndrome: Reye's syndrome may develop in individuals who have chicken pox, influenza or flu symptoms. Hypersensitivity including rash, angioedema or hematologic reaction has been reported in patients receiving this combination or history of hypersensitivity to other thienopyridines
+
","It should not be given to children, particularly those under 12 years, unless the expected benefits outweight the possible risks. Aspirin may be a contributory factor in the causation of Reye’s syndrome in some children.
","Clopidogrel overdose may lead to bleeding complications. Based on biological plausibility, platelet transfusion may restore clotting ability. In moderate aspirin intoxication dizziness, headache, tinnitus, confusion, and gastrointestinal symptoms may occur which can be treated by inducing vomiting followed by gastric lavage if needed. In severe Aspirin intoxication respiratory alkalosis respiratory acidosis, metabolic acidosis, hyperthermia, perspiration, dehydration can occur. It can be treated with haemodialysis and other symptomatic treatment.
",,,"Keep in a cool & dry place (below 30o C), protected from light & moisture. Keep out of the reach of children.
",12
+285,Clonidine Hydrochloride,clonidine-hydrochloride-285,https://medex.com.bd/attachments/xfHb1IXLCzNLYzvOsMtCaWqEBf4oYY/clonidine-hydrochloride-prescribing-information,Centrally acting antihypertensive drugs (central sympatholytic),Social anxiety disorder,"Clonidine is indicated in Anxiety, Cancer pain, Generalized anxiety disorder, Hypertension, Hypertensive crisis, Menopausal flushing, Migraine, Panic disorder, Severe anxiety disorders, Social anxiety disorder
","Centrally acting antihypertensive drugs (central sympatholytic)
","Clonidine stimulates α2-adrenoceptors in the brain stem which results in reduced sympathetic outflow from the CNS, and a decrease in peripheral resistance, heart rate, BP and renal vascular resistance.
","Adults: The dose of Clonidine tablets must be adjusted according to the patient's individual blood pressure response. The following is a general guide to its administration.
Initial Dose: 0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose.
Maintenance Dose: Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed.
",,"Increased hypotensive effect with other antihypertensives e.g. diuretics, β-blockers, vasodilators, Ca antagonists, ACE inhibitors. Reduced antihypertensive effect and induced orthostatic hypotension with TCAs or neuroleptics with α-receptor blocking properties. Reduced therapeutic effect with NSAIDs.
","Severe bradyarrhythmia secondary to 2nd- or 3rd-degree AV block or sick sinus syndrome.
","Headache, dizziness, drowsiness, dry mouth, constipation, depression, anxiety, nausea, fatigue, anorexia, parotid pain, paraesthesia, delusional perception, sleep disturbances, vivid dreams, impotence and loss of libido, urinary retention or incontinence, orthostatic hypotension, itching or burning sensations in the eye, accommodation disorder, decreased lacrimation, fluid retention, pruritus and rashes (transdermal), bradycardia, other ECG disturbances, heart failure, hallucinations, cramp, Raynaud's syndrome, gynaecomastia, transient abnormalities in LFTs.
","Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Patient with cerebrovascular disease, ischaemic heart disease including MI, occlusive peripheral vascular disorders (e.g. Raynaud's disease), or those w/ history of depression. Avoid abrupt withdrawal. Renal impairment. Pregnancy and lactation.
","Renal Impairment: Patients with renal impairment may benefit from a lower initial dose. Patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.
","Symptoms: Lethargy, pupillary constriction, hypotension, hypothermia, bradycardia, decreased or absent reflexes, irritability, miosis, weakness, somnolence (including coma) and resp depression (including apnoea). Paradoxical HTN may occur.
Management: Perform gastric lavage following recent ingestion or admin activated charcoal and/or a cathartic. Supportive treatment may include admin of atropine sulfate for symptomatic bradycardia; IV fluids and/or inotropic sympathomimetic agents for hypotension; vasodilators for HTN. Naloxone may be used as adjunct for clonidine-induced resp depression, hypotension and/or coma.
",,,"Store between 20-25°C.
",12
+284,Clonazepam,clonazepam-284,https://medex.com.bd/attachments/mHybmwOfUAViyJfOyTLy823AHDF4Mg/clonazepam-tablet-prescribing-information,Adjunct anti-epileptic drugs,,"It is indicated for the treatment of panic disorder, with or without agoraphobia. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks.
It is also indicated ... Read more
It is indicated for the treatment of panic disorder, with or without agoraphobia. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks.
It is also indicated alone or as an adjunct in the treatment of the Lennox-Gastaut Syndrome (petit mal variant), akinetic and myoclonic seizures. It may be indicated in patients with absence seizures (petit mal) who have failed to respond to succinimides.
The effectiveness of Clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use Clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
","Adjunct anti-epileptic drugs, Benzodiazepine hypnotics
","Clonazepam exhibits pharmacological properties which are common to benzodiazepines and include anticonvulsive, sedative, muscle relaxing and anxiolytic effects. The central actions of benzodiazepines are mediated through an enhancement of the GABAergic neurotransmission at inhibitory synapses. In the presence of benzodiazepines the affinity of the GABA receptor for the neurotransmitter is enhanced through positive allosteric modulation resulting in an increased action of released GABA on the postsynaptic transmembrane chloride ion flux.
There are also animal data showing an effect of clonazepam on serotonin. Animal data and electroencephalographic investigations in man have shown that clonazepam rapidly suppresses many types of paroxysmal activity including the spike and wave discharge in absences seizures (petit mal), slow spike wave, generalized spike wave, spikes with temporal or other locations as well as irregular spikes and waves. Generalized EEG abnormalities are more regularly suppressed than focal abnormalities. According to these findings clonazepam has beneficial effects in generalized and focal epilepsies.
","Oral:
+
+- Adults: The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg.
+
+
+- The initial dose for adults with panic disorder is 0.25 mg given in two divided dose. An increase to the target dose for most patients of 1 mg/day may be made after 3 days.
+- Pediatric Patients: In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses.
+
+
Injection:
+
+- Infants and children: half of a vial (0.5 mg) by slow IV injection or by IV infusion.
+
+
+- Adults: 1 vial (1 mg) by slow IV injection or by IV infusion. This dose can be repeated as required (1-4 mg are usually sufficient to reverse the status). In adults, the rate of injection must not exceed 0.25 - 0.5 mg per minute (0.5-1.0 ml of the prepared solution) and a total dose of 10 mg should not be exceeded.
+
",,"Clonazepam does not appear to alter the pharmacokinetics of phenytoin, carbamazepine or phenobarbital. The effect of Clonazepam on the metabolism of other drugs has not been investigated.
","It should not be used in patients with a history of hypersensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.
","The most frequently occurring side effects of Clonazepam are referable to CNS depression. Experience in treatment of seizures has shown that drowsiness has occurred in approximately 50% of patients and ataxia in approximately 30%. In some cases, these may diminish with time; behavior problems have been noted in approximately 25% of patients. Abnormal eye movements, aphonia, coma, tremor, vertigo, confusion, depression, amnesia, hallucinations, hysteria, increased libido, insomnia, psychosis & palpitations may also occur.
","Pregnancy: From preclinical studies it cannot be excluded that clonazepam possesses the possibility of producing congenital malformations. From epidemiological evaluations there is evidence that anticonvulsant drugs act as teratogens. However, it is difficult to determine from published epidemiological reports which drug or combination of drugs is responsible for defects in the newborn. The possibility also exists that other factors e.g. genetic factors or the epileptic condition itself may be more important than drug therapy in leading to birth defects. Under these circumstances, the drug should only be administered to pregnant women if the potential benefits outweigh the risk to the foetus. During pregnancy, Clonazepam may be administered only if there is a compelling indication. Administration of high doses in the last trimester of pregnancy or during labour can cause irregularities in the heartbeat of the unborn child and hypothermia, hypotonia, mild respiratory depression and poor feeding in the neonate. It should be borne in mind that both pregnancy itself and abrupt discontinuation of the medication can cause exacerbation of epilepsy. Withdrawal symptoms in newborn infants have occasionally been reported with benzodiazepines.
Nursing Mothers: Although the active ingredient of Clonazepam has been found to pass into the maternal milk in small amounts only, mothers undergoing treatment with this drug should not breastfeed. If there is a compelling indication for Clonazepam, breastfeeding should be discontinued.
","When used in patients in whom several different types of seizure disorders coexist, Clonazepam may increase the incidence or precipitate the onset of generalized tonic-clonic seizures. This may require the addition of appropriate anticonvulsants or an increase in their dosages. The concomitant use of valproic acid and Clonazepam may produce absence status.
","Pediatric Use: In infants and small children Rivotril may cause increased production of saliva and bronchial secretion. Therefore special attention must be paid to maintaining patency of the airways.
Geriatric Use: Benzodiazepine pharmacologic effects appear to be greater in elderly patients than in younger patients even at similar plasma benzodiazepine concentrations, possibly because of age-related changes in drug–receptor interactions, post-receptor mechanisms and organ function.
Renal Impairment: Renal impairment does not affect the pharmacokinetics of clonazepam. Based on pharmacokinetic criteria, no dose adjustment is required in patients with renal impairment.
Hepatic Impairment: Plasma protein binding of clonazepam in cirrhotic patients is significantly different from that in healthy subjects (free fraction 17.1±1.0% vs 13.9±0.2%). Although the influence of hepatic impairment on clonazepam pharmacokinetics has not been further investigated, experience with another closely related nitrobenzodiazepine (nitrazepam) indicates that clearance of unbound clonazepam might be reduced in liver cirrhosis.
","Symptoms: Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdose of Clonazepam is seldom life-threatening if the drug is taken alone, but may lead to areflexia, apnoea, hypotension, cardiorespiratory depression and coma. Coma, if it occurs, usually lasts a few hours but it may be more protracted and cyclical, particularly in elderly patients. Increased frequency of seizures may occur in patients at supratherapeutic plasma concentrations. Benzodiazepine respiratory depressant effects are more serious in patients with respiratory disease. Benzodiazepines increase the effects of other central nervous system depressants, including alcohol.
Treatment: Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects. Further absorption should be prevented using an appropriate method e.g. treatment within 1-2 hours with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure. If CNS depression is severe consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants). Refer to the prescribing information for flumazenil, for further information on the correct use of this drug.
",,"Slow intravenous injection: The contents of the vial must be diluted with 1 ml of water for injection prior to administration so as to avoid local irritation of the veins. The injection solution should be prepared immediately before use. IV injection should be administered slowly with continuous monitoring of EEG, respiration and blood pressure.
Intravenous infusion: Clonazepam (the vial) can be diluted for infusion in a ratio of 1 vial (1 mg) to at least 85 ml diluting media. The diluting media can be any of the following: sodium chloride 0.9%; sodium chloride 0.45% + glucose 2.5%; glucose 5% or glucose 10%. These mixtures are stable for 24 hours at room temperature. Infusion bags other than PVC should be used for infusing Clonazepam. If PVC infusion bags are used then the mixture should be infused immediately or within 4 hours. The infusion time should not exceed 8 hours. Do not prepare Clonazepam infusions using sodium bicarbonate solution, as precipitation of the solution may occur.
Intramuscular injection: The IM route should be used only in exceptional cases or if IV administration is not feasible.
","Keep in a dry place away from light and heat. Keep out of the reach of children.
",13
+283,Clomipramine Hydrochloride,clomipramine-hydrochloride-283,https://medex.com.bd/attachments/w6pumdXIuXGEL5n9YYDyu3TuhHuTmu/clomipramine-hydrochloride-apotex-prescribing-information,Tricyclic & related anti-depressant drugs,Trichotillomania,"Clomipramine Hydrochloride is used to treat depression, obsessions and phobias (irrational fears). It is also used to treat muscular weakness (cataplexy) associated with repeat attacks of extreme sleepiness (narcolepsy) in adults.
","Tricyclic & related anti-depressant drugs
","Clomipramine hydrochloride belongs to a group of medicines called ""tricyclic antidepressants"". This is thought to work either by increasing the amount of chemical ""messengers"" in the brain or by making their effects last longer. Clomipramine is a potent inhibitor of serotonin re-uptake in the brain. Significant antagonism at cholinergic and α1-receptors. Weak antagonism at dopamine receptors. It has also antidepressant, sedative and anticholinergic effects.
","The usual dosages for adults are as follows:
+
+- For depression: 10 mg to 150 mg daily. Severe cases may need even higher doses.
+- For obsessions and phobias: 10 mg to 150 mg daily.
+- For cataplexy: 10 mg to 75 mg daily.
+
+The elderly: Elderly patients often need a lower dose because they are more likely to experience side effects.
","Swallow this capsules whole with a drink of water. Keep taking your medicine until your doctor tells you to stop. Do not stop because you do not feel any better. This medicine may take up to 4 weeks to work. The medicine may be taken as one dose at night or as smaller doses at intervals during the day.
","In particular, do not take this if you are taking the following: medicines for depression called monoamine oxidase inhibitors (MAOIs), or have taken them within the last 3 weeks.
","
+- Known hypersensitivity to clomipramine and any of the excipients in the tablets.
+- Cross-hypersensitivity to tricyclic antidepressants of the dibenzazepine group.
+- Concomitant use with a monoamine oxidase (MAO) inhibitor, or within 14 days before or after treatment with an irreversible MAO inhibitor, or within 14 days before moclobemide, a reversible MAO inhibitor.
+- Acute and recovery stages of myocardial infarction.
+- Congenital long QT syndrome.
+
","Very common side effects are increase in appetite and weight gain, headaches, dizziness, nausea, constipation, dry mouth, increased sweating, shaking hands, tremor, difficulty in passing urine, problems with their eyes, feeling tired or sleepy, sexual disturbances, restlessness.
","Pregnancy category C. As clomipramine passes into human milk, babies should be weaned or clomipramine gradually withdrawn.
","Check with your doctor or pharmacist before taking your medicine if:
+
+- you have epilepsy (fits)
+- you have an overactive thyroid gland
+- you have a tumour (cancer) of the adrenal gland (such as phaeochromocytoma or neuroblastoma)
+- you have low blood pressure
+- you wear contact lenses
+- you have had severe constipation for a long time
+- you find yourself thinking about suicide
+- you have had a head injury and suffered brain damage
+- you are going to have ECT (electroconvulsive therapy)
+- you have an irregular heart beat or other problems with your heart
+- you have been diagnosed as having a low level of potassium in your blood (hypokalemia)
+- you have schizophrenia or any other mental disorder
+- you are elderly
+- you have glaucoma(increased pressure in the eye)
+- you have liver or kidney disease
+- you have any blood disorder
+- you have difficulties in passing urine (e.g. due to diseases of the prostate)
+
","Older people: Elderly patients generally need lower doses than young and middle-aged patients. Side effects are more likely to occur in older patients.
Use in Children and Adolescents (<18 years): The safety and efficacy of clomipramine for the treatment of depression or other psychiatric disorders in children and adolescents aged less than 18 years has not been satisfactorily established. Clomipramine should not be used in this age group for the treatment of depression or other psychiatric disorders
",,,,"Keep out of the reach and sight of children. The capsules should be protected from heat and moisture.
",12
+282,Clomiphene Citrate,clomiphene-citrate-282,https://medex.com.bd/attachments/cozj1MEMJ9ET4BxQIxcJ70YkxZbbNN/clomiphene-citrate-prescribing-information,Drugs for Infertility,Stimulate ovulation,"Clomiphene citrate is chiefly indicated for the treatment of ovulatory failure in female patients who wish to become pregnant. This therapy will not be successful unless the patient though unovulatory, is capable of ovulation & her partner is fertile.
Clomiphene citrate is also indicated ... Read more
Clomiphene citrate is chiefly indicated for the treatment of ovulatory failure in female patients who wish to become pregnant. This therapy will not be successful unless the patient though unovulatory, is capable of ovulation & her partner is fertile.
Clomiphene citrate is also indicated for the Polycystic ovary syndrome, Menorrhagia caused by hyperplastic endometrium, Amenorrhea with galactorrhea syndrome, Psychogenic amenorrhea syndrome, Secondary amenorrhea of unknown cause, Amenorrhea during post oral contraceptive period
","Drugs for Infertility
","Clomiphene has mainly antiestrogenic effects and some estrogenic effects. The mechanism in stimulating ovulation is unknown but is believed to be related to its antiestrogenic properties. By clomiphene competing with estrogen for binding sites at the hypothalamic level, the gonadotropins, follicle-stimulating hormone (FSH) and luteinizing hormone (LH), secretion is increased, which results in ovarian follicle maturation, followed by the preovulatory LH surge, ovulation, and the subsequent development of the corpus luteum. Usefulness in male infertility is also likely related to the increases in FSH and LH secretion.
","The usual dose for the first course of Clomiphene is 50 mg (1 tablet) a day for 5 days in the early follicular phase of the cycle, following normal menstruation or a progestagen-induced withdrawal bleeding. Many regimes have been used, but most common begin either on day 2 or day 5. If this dose induces ovulation, there is no need to increase the dose in the following courses. If this dose induces ovulation, but pregnancy does not occur, stimulation with Clomiphene Citrate is to be continued, but up to 6 stimulative courses. If the first course does not induce ovulation, the second course should be started with 100 mg a day (2 tablets of 50 mg taken in a single dose) for 5 days. If ovulation is not induced, 2 more stimulative courses of the same dose should be given. If the next three stimulative courses do not produce a successful result, the therapeutic trial is considered to be finished. If ovulation is induced, but pregnancy does not occur, maximum 6 courses with Clomiphene are recommended. However, if menstrual bleeding does not occur, the patient should be examined carefully for the possible pregnancy, and the next course of therapy should be delayed until the correct diagnosis has been determined.
",,"No drug interaction has been reported during the administration of Clomiphene citrate.
","Clomiphene citrate is contraindicated during pregnancy, in patients with liver diseases, ovarian cysts, bleeding of undetermined origin, patients with neoplasm of endometrium.
","Clomiphene Citrate is well tolerated. However a few side effects like dizziness, headache, nausea, vomiting, depression, fatigue, insomnia, vasomotor flushing, and allergic reaction may occur. Rarely ovarian enlargement and cyst formation may occur. All these effects disappear promptly after the treatment is discontinued.
","This is not recommended in pregnancy. In some cases Clomiphene citrate may reduce lactation, if it is administered to a woman during lactating period. So it should be avoided during lactational period.
","Clomiphene citrate should be used with caution in longer maintenance therapy, with alcoholic drinks & antidepressants.
",,"No such effects of acute over dosage of Clomiphene citrate have been reported. However, in case of over dosage, a few sign symptoms of nausea, vomiting, vasomotor flushes, scotoma, and ovarian enlargement with pelvic or abdominal pain may occur. In the event of over dosage appropriate supportive measures should be employed.
",,,"Clomiphene Citrate tablet should be stored below 25° C and protected from light & moisture.
",11
+281,Clobetasone Butyrate,clobetasone-butyrate-281,https://medex.com.bd/attachments/5fgDC7GyyX5tAk7tZG9dYXOOY7Vy19/clobetasone-butyrate-prescribing-information,Clobetasol / Clobetasone & Combined Preparations,Seborrhoeic dermatitis,"Clobetasone preparations are indicated for the treatment of eczema and dermatitis of all types including atopic eczema, photodermatitis, otitis externa, primary irritant allergic dermatitis (including napkin rash), intertrigo, prurigo nodularis, seborrhoeic dermatitis and insect bite reactions. Clobetasone may be used as a maintenance therapy between courses of one of the more active topical steroids.
","Clobetasol / Clobetasone & Combined Preparations
","Clobetasone Butyrate is a topically active corticosteroid, which provides an exceptional combination of activity and safety. It is more effective in the treatment of eczemas than 1% Hydrocortisone, or the less active synthetic steroid preparations that are in common use. It has little effect on hypothalamic-pituitary-adrenal function. All topical corticosteroids can cause cutaneous atrophy if grossly misused. However, study in animal and human models indicates that Clobetasone Butyrate causes less thinning of the epidermis than the other topical steroid tested.
","Apply to the affected area up to four times a day until improvement occurs, when the frequency of application may be reduced.
",,"Potentially hazardous interactions- none has been reported. Potentially useful interactions- none has been reported.
","Pregnancy (in high doses), Presence of acute infections, Treatment of rosacea, Leg ulcers, Acne vulgaris, Widespread plaque psoriasis. Child <1 yr.
","Local atrophic changes; pigmentation changes & hypertrichosis. Increased liability to infection. Infections may be masked. Acute adrenal insufficiency. Growth retardation in child. Cushingoid symptoms. Amenorrhoea, hyperhidrosis, skin thinning
","There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the human fetus.
","May be absorbed in sufficient amounts to cause systemic effects when applied topically to large areas, broken skin or under occlusive dressings. Peptic ulcer, osteoporosis, psychoses or severe psychoneuroses. Not to be used indiscriminately for pruritus. CHF or hypertension. Diabetes mellitus, epilepsy, glaucoma, infectious diseases, ocular herpes simplex, chronic renal failure and uraemia. Active or doubtfully quiescent tuberculosis. Local treatment of eye disorders. Elderly. Prolonged use on the face.
",,"Acute overdosage is very unlikely to occur, in the case of chronic overdosage or misuse the features of hypercorticism may appear and in this situation topical steroids should be discontinued.
",,,"Store below 30˚ C. Do not freeze. Protect from light.
",11
+279,Clobetasol Propionate + Salicylic Acid,clobetasol-propionate-salicylic-acid-279,,Clobetasol / Clobetasone & Combined Preparations,Warts,"This ointment is indicated for the relief of the inflammatory manifestations of hyperkeratotic and dry corticosteroid responsive dermatoses such as, psoriasis, chronic atopic dermatitis, neurodermatitis (licehen Simplex, Chronicus), lichen planus, eczema (including nummular eczema, hand eczema, eczematous ... Read more
This ointment is indicated for the relief of the inflammatory manifestations of hyperkeratotic and dry corticosteroid responsive dermatoses such as, psoriasis, chronic atopic dermatitis, neurodermatitis (licehen Simplex, Chronicus), lichen planus, eczema (including nummular eczema, hand eczema, eczematous dermatitis), seborrheic dermatitis of the scalp, ichthyosis vulgaris and other ichthyotic conditions.
","Clobetasol / Clobetasone & Combined Preparations
","Clobetasol Propionate high potency corticosteroid. Corticosteroids decrease inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; and reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation.
Salicylic acid has a potent keratolytic action and a slight antiseptic action when applied topically. It softens and destroys the stratum corneum by increasing endogenous hydration which causes the horny layer of the skin to swell, soften, and then desquamate. At high concentrations, salicylic acid has a caustic effect. It also possesses weak antifungal and antibacterial activity.
","Adult: Apply a thin layer of this ointment to the affected skin areas twice daily and rub in gently & completely. For some patients, adequate maintenance therapy may be achieved with less frequent application. As with other higher active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. It should not be used with occlusive dressing. Treatment beyond 2 consecutive weeks is not exceeding 50 gm/week because of the potential for the drug to suppress the hypothalamic pituitary adrenal axis.
Children: Use in pediatric patients under 12 years of age is not recommended.
","For external use only.
","There has been no report of interaction with Clobetasol Propionate ointment and cream. There are no known interactions of Salicylic Acid when used as indicated. However, topical salicylic acid may increase the absorption of other topically applied medicines. Concomitant use of Salicylic Acid Ointment and other topical medicines on the same area of skin should therefore be avoided.
","ClobetasolPropionatev is contraindicated in patients with hypersensitivity to Clobetasol Propionate. This preparation is contraindicated also in the treatment of primary infected bacterial or fungal skin lesions if no anti-infective agent is used simultaneously, in primary cutaneous viral infections (i.e., herpes simplex, vaccinia and varicella) and in tuberculous skin lesions. Clobetasol Propionate is also contraindicated in dermatoses in children under one year of age, including dermatitis and diaper eruptions. Salicylic Acid is contraindicated in patients displaying salicylate hyersensitivity, or sensitivity to any other ingredient in the preparation.
","As with other topical corticosteroids, prolonged use of large amounts of Clobetasol Propionate or treatment of extensive areas can result in sufficient systemic absorption to produce the features of hypercortisolism. This effect is more likely to occur in infants and children, and if occlusive dressings are used. Local atrophy may occur after prolonged treatment. In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked the pustular form of the diseases. Clobetasol Propionate is usually well tolerated, but if signs of hypersensitivity appear, application should be stopped immediately. Possible sensitivity reactions, drying and irritation when using Salicylic Acid.
","Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development. The relevance of this finding to human beings has not been established. The safe use of Clobetasol Propionate during lactation has not been established. However, the administration of Clobetasol Propionate during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. Drugs of this class should not be used extensively in pregnant patients in large amounts or for prolonged periods of time. Whilst there are no known contra-indications to the use of Salicylic Acid ointment during pregnancy and lactation, the safety has not been established. Salicylic Acid ointment shold therefore be used with caution.
","Not for prolonged use in high concentrations and on large areas of the body. Impaired peripheral circulation or diabetes. Avoid broken skin, mouth, eyes, mucous membranes and anogenital region.
",,"Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse, the features of hypercortisolism may appear and in this situation topical steroids should be discontinued gradually. However, because of the risk of acute adrenal suppression this should be done under medical supervision. Symptoms osslystemic salicylate poisoning (tinnitus, dizziness and deafness) have been reported after the application of Salicylic Acid to large areas of skin and for prolonged periods. Salicylism may also occur in the unlikely event of large quantities being ingested. Salicylism is ullikely to occur if Salicylic Acid ointment is used as indicated. Salicylate poisoining is usually associated with plasma concentrations >350 mg/L. Most adult deaths occur in patients whose concentrations exceed 700 ml/L. Single doses less than 100 mg/kg are unlikely to cause serious poisoning.
",,,"Store in a cool and dry place, protected from light.
",12
+1578,Clobetasol Propionate + Ofloxacin + Ornidazole + Terbinafine,clobetasol-propionate-ofloxacin-ornidazole-terbinafine-1578,,Clobetasol / Clobetasone & Combined Preparations,Vaginitis,"This cream is indicated in the treatment of-
+
+- Mixed and complicated Fungal, Protozoal & Bacterial infections,
+- Mild to moderate vaginitis,
+- Candidiasis and trichomoniasis,
+- Pruritus vulvae,
+- Dermatitis,
+- Eczema,
+- Genito-urinary infections.
+
","Clobetasol / Clobetasone & Combined Preparations
","This cream is a combination cream which exhibits anti-bacterial, anti-fungal, anti-protozoal & anti-inflammatory actions. Ofloxacin is a broad-spectrum antibiotic that acts against many gram-positive & gram-negative bacteria. Ornidazole belongs to the nitroimidazole group of antibiotics and is used to treat amoeba and trichomonas infections. Terbinafine is an Allylamine antifungal that inhibits biosynthesis of Ergosterol (an essential components if fungal cell membrane) via inhibition of Squalene Epoxidase enzyme causing fungal cell death. Clobetasol is a potent corticosteroid which exhibits anti-inflammatory, anti-pruritic and vasoconstrictive properties.
","Apply by gently rubbing onto the affected area twice daily.
",,"No hazardous interactions have been reported.
","Contraindicated in patients hypersensitive to any of the components of the formulation.
","Burning, itching, irritation, dry skin
","The safe use of this preparation during pregnancy & lactation has not been established.
","Do not shallow. For external use only
",,,,,"Store below 30°C. keep away from light and out of the reach of children. Do not freeze.
",10
+278,Clobetasol Propionate + Neomycin Sulphate + Nystatin,clobetasol-propionate-neomycin-sulphate-nystatin-278,https://medex.com.bd/attachments/3ehYWyetWyQkcRW598qHRnD1gK3Fws/clobetasol-propionate-neomycin-sulphate-nystatin-prescribing-information,Clobetasol / Clobetasone & Combined Preparations,Severe inflammatory skin disorders,"This preparation is indicated in-
+
+- Short courses treatment of recalcitrant eczemas.
+- Neurodermatoses.
+- Psoriasis (excluding widespread plaque psoriasis) where secondary bacterial infection or fungal infection is present, suspected or likely to occur.
+- Other inflammatory conditions which do not respond satisfactorily to less active steroids.
+
","Clobetasol / Clobetasone & Combined Preparations
","Clobetasol Propionate is a very potent corticosteroid. It is prescribed to treat severe inflammatory skin disorders such as eczema and psoriasis that have not responded to weaker corticosteroids. Neomycin Sulphate is an antibiotic of the aminoglycoside type and is used to treat infections with bacteria. Nystatin is an antifungal that kills fungi and yeasts by interfering with their cell membranes. The mechanism of the topical steroids like Clobetasol, in general, is unclear. However, Clobetasol Propionate is highly active corticosteroid with topical anti-inflammatory activity. The major effect of Clobetasol Propionate on skin is a nonspecific anti-inflammatory response, partially due to vasoconstriction and decrease in collagen synthesis. Neomycin binds to the ribosomal 30s and 50s sub-units of susceptible bacteria and inhibits protein synthesis. Neomycin also causes a misreading of the genetic codes of the mRNA template and this causes incorrect amino acids to be incorporated into the growing polypeptide chain. Nystatin acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components.
","Adults: Apply sparingly to the affected area once or twice daily until improvement occurs. In very resistant lesion, especially where there is hyperkeratosis, the anti-inflammatory effect of this preparation can be enhanced (if necessary) by occluding the treatment area with polythene. Treatment should not be continued for more than 7 days without medical supervision. If a longer course is necessary, it is recommended that treatment should not be continued for more than 4 weeks without the patient's condition being reviewed.
Elderly: This preparation is suitable for use in elderly. Caution should be exercised in cases where a decrease in renal function exists and significant systemic absorption of Neomycin Sulphate may occur.
Children: This preparation is suitable for use in children (2 years and over) at the same dose as adults. A possibility of increased absorption exists in very young children, thus this cream/ointment is not recommended for use in neonates and infants (younger than 2 years).
",,"Neomycin Sulphate can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents following significant systemic absorption. However, if used in accordance with the recommendations, systemic exposure to Neomycin Sulphate is expected to be minimal and drug interactions are unlikely to be significant. No hazardous interactions have been reported with use of Clobetasol Propionate or Nystatin.
","This medication is contraindicated in rosacea, acne vulgaris and perioral dermatitis, primary cutaneous viral infection (eg-Herpes simplex, chicken pox) and hypersensitivity to the preparation.
","As with other topical corticosteroids, prolonged use of large amount or treatment of extensive areas can result in sufficient systemic absorption to produce the features of hypercortisolism. The effect is more likely to occur in infants and children and if occlusive dressings are used. Prolonged and intensive treatment with highly active corticosteroid preparations may cause local atrophic changes in the skin such as thinning, striae, and dilatation of the superficial blood vessels, particularly when occlusive dressings are used, or when skin folds are involved. There are reports of pigmentation changes and hypertrichosis with topical steroids.
","There is little information to demonstrate the possible effect of topically applied Neomycin in pregnancy and lactation. However, Neomycin present in the maternal blood can cross the placenta and may give rise to a theoretical risk of foetal toxicity, thus the use of the preparation is not recommended in pregnancy and lactation. The safety of Clobetasol Propionate has not been established in lactating mothers.
","Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression can occur readily even without occlusion. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result. If this medication does enter the eye, the affected eye should be thoroughly washed with copious amount of water.
",,"Acute overdosage is very unlikely to occur. No overdose-related problem yet reported. However, in the case of chronic overdosage or misuse, the features of hypercortisolism may appear and in this situation, topical steroids should be discontinued gradually.
",,,"Store below 25°C temperature. Do not freeze. Keep out of reach of children.
",11
+280,Clobetasol Propionate (Topical Preparation),clobetasol-propionate-topical-preparation-280,https://medex.com.bd/attachments/AjVxxUWTw779PYgY1HbiH4yPUU0aGi/clobetasol-propionate-topical-preparation-cream-ointment-prescribing-information,Other Topical corticosteroids,Vitiligo,"Clobetasol Propionate is indicated for adults, elderly and children over 1 year in following dermatoses.
+
+- Psoriasis (excluding widespread plaque psoriasis)
+- Recalcitrant dermatoses
+- Lichen planus
+- Discoid lupus erythematosus
+- Other skin conditions which do not respond satisfactorily to less potent steroids
+
","Other Topical corticosteroids
","Clobetasol Propionate is a very potent topical corticosteroid. It has anti-inflammatory, antipruritic and vasoconstrictive properties. It shows anti-inflammatory activity via multiple mechanisms to inhibit late phase allergic reactions. It decreases the density of mast cells, chemotaxis and activation of eosinophils. It also reduces cytokine production and inhibits the metabolism of arachidonic acid.
","Adults, elderly and children over 1 year: Apply a thin layer of Clobetasol Propionate Cream or Ointment to the affected skin areas twice daily and rub in gently and completely. Repeated short courses of Clobetasol Propionate may be used to control exacerbations. In more resistant lesions, especially where there is hyperkeratosis, the effect of Clobetasol can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response. Clobetasol Propionate is super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks. The maximum weekly dose should not be exceeded 50 gm/week. In case of children, courses should be limited if possible to five days and reviewed weekly.
","Route of administration: Cutaneous. Creams are especially appropriate for moist or weeping surfaces. Ointments are especially appropriate for dry, lichenified or scaly lesions.
","Co-administered drugs that can inhibit CYP3A4 (eg ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure.
","It is contraindicated in patient with hypersensitivity to any component of the preparation. It should not be used in rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritus, pruritus without inflammation, untreated cutaneous infections.
","The most reported side effects are burning and stinging sensation. Less frequent adverse reactions are itching, skin atrophy, cracking and fissuring of the skin. Cushing syndrome has been reported in infants and adults as a result of prolonged use of topical Clobetasol Propionate formulations.
","There are limited data from the use of Clobetasol Propionate cream in pregnant women. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to humans has not been established. However, the administration of Clobetasol Propionate Cream during pregnancy and lactation should only be considered if the expected benefit to the mother outweighs the possible risks of treatment.
It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol Propionate Cream is administered to a nursing woman.
","In case of using occlusive dressings, the skin should be cleansed before a fresh dressing is applied. Topical corticosteroids should be used with caution in psoriasis as rebound relapses, and development of local or systemic toxicity due to impaired barrier function of the skin may occur. If used on the face, treatment should be limited to 5 days. When Clobetasol Propionate used on eyelids, care should be taken to avoid the eyes as cataract and glaucoma might result from repeated exposure.
","In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur. Children are more susceptible to the use of topical corticosteroids which develops atrophic changes.
","Acute overdosage is very unlikely to occur, however, in the case of chronic over-dosage or misuse the features of hypercortisolism may occur and in this situation topical steroid should be discontinued.
",,,"Keep below 30°C temperature, protected from light and moisture. Do not freeze. Keep out of the reach of children.
",13
+1582,Clobetasol Propionate (Scalp Preparation),clobetasol-propionate-scalp-preparation-1582,,Other Topical corticosteroids,Seborrheic dermatitis of the scalp,"Clobetasol Propionate scalp solution is indicated in the topical therapy of recalcitrant corticosteroid-responsive dermatoses of the scalp, including recalcitrant cases of psoriasis and seborrheic dermatitis.
","Other Topical corticosteroids
","Clobetasol Propionate is a very potent topical corticosteroid. It has anti-inflammatory, antipruritic and vasoconstrictive properties. It shows anti-inflammatory activity via multiple mechanisms to inhibit late phase allergic reactions. It decreases the density of mast cells, chemotaxis and activation of eosinophils. It also reduces cytokine production and inhibits the metabolism of arachidonic acid.
","Clobetasol Propionate spray: Apply required quantity of spray of once or twice daily to the affected areas of the scalp and gently rub in. The total dose applied should not exceed 50 ml weekly. If necessary, Clobetasol Propionate scalp solution may be massaged into the scalp using the tips of the fingers. Therapy should be discontinued if no response is noted after one week or as soon as the lesion heals. It is advisable to use Clobetasol Propionate scalp solution for brief periods only.
Clobetasol Propionate shampoo: It should be applied to the dry (not wet) scalp once a day to the affected areas only. It should be massaged gently into the lesions and left in place for 15 minutes before lathering and rinsing. Treatment should be limited to 4 consecutive weeks. Total dosage of shampoo should not exceed 50 g per week. Under 18 years this preparation is not recommended.
Scalp Solution: Apply required quantity of spray of Clobetasol Scalp Solution once or twice daily to the affected areas of the scalp and gently rub in. The total dose applied should not exceed 50 ml weekly. If necessary, Clobetasol Scalp Solution may be massaged into the scalp using the tips of the fingers. Therapy should be discontinued if no response is noted after one week or as soon as the lesion heals. It is advisable to use Clobetasol Scalp Solution for brief periods only.
",,,"
+- Infections of the scalp
+- Hypersensitivity to the preparation
+- Use is not indicated in dermatoses in children under one year of age
+
","As with other corticosteroids, prolonged use of large amounts or treatment of extensive areas, can result in sufficient systemic absorption to produce the features of hypercortisolism. This effect is more likely to occur in infants and children, and if occlusive dressings are used. Local atrophy may occur after prolonged treatment. In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked the pustular form of the disease. If signs of hypersensitivity appear with the use of Clobetasol Propionate Scalp Solution then application should be stopped immediately.
","Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established; however, topical steroids should not used extensively in pregnancy, i.e. in large amounts for prolonged periods. The safe use of Clobetasol Propionate during lactation has not been established.
","Care must be taken to keep the preparation away from the eyes. Long-term continuous therapy with Clobetasol Propionate scalp solution should be avoided where possible, particularly in infants and children, as adrenal suppression can occur even without occlusion. Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, risk of generalized pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used on psoriasis, careful patient supervision is important. Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and systemic administration of antimicrobial agents. Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and so the skin should be cleansed before a fresh dressing is applied.
",,,,,"Keep below 30��C temperature, protected from light and moisture. Do not freeze. Keep out of the reach of children.
",9
+277,Clobazam,clobazam-277,https://medex.com.bd/attachments/ZPeCf63HXmGsayM1aLnhZaUyHpltZx/clobazam-prescribing-information,Benzodiazepine hypnotics,Tension,"Acute and chronic anxiety states which may produce the following symptoms in particular: anxiety, tension, restlessness, excitement, irritability, sleep disturbances from emotional causes, psychovegetative and psychosomatic disorders (for example, in the cardiovascular or gastrointestinal area), and ... Read more
Acute and chronic anxiety states which may produce the following symptoms in particular: anxiety, tension, restlessness, excitement, irritability, sleep disturbances from emotional causes, psychovegetative and psychosomatic disorders (for example, in the cardiovascular or gastrointestinal area), and emotional instability.
In patients with depression or anxiety associated with depression, Clobazam must be used only in conjunction with adequate concomitant treatment. Use of benzodiazepines alone, can precipitate suicide in such patients. Before treatment of anxiety states associated with emotional instability, it must first be determined whether the patient suffers from a depressive disorder requiring adjunctive or different treatment.
In patients with schizophrenic or other psychotic illnesses, use of benzodiazepines is recommended only for adjunctive, i.e. not for primary treatment.
As adjunctive therapy in patients with epilepsy who are not adequately stabilized with their anticonvulsant monotherapy.
","Benzodiazepine hypnotics
","Clobazam binds at distinct binding sites associated with the chloride ionopore at the post-synaptic GABA receptor. These GABA receptors are in various locations in the CNS (limbic, reticular formation) and clobazam increases the duration of time for which the chloride ionopore is open. As a result, hyper polarization and stabilization of the membrane occur as the post-synaptic inhibitory effect of GABA is enhanced.
","General Dosage: Dosage and duration of treatment must be adjusted to the indication, the severity of the condition and the individual clinical response. Due regard must be paid to the possibility of interference with alertness and reaction time. The fundamental principle is to keep the dose as low as possible.
+
Treatment of anxiety states-
+Adults and adolescents over 15 years of age: The initial dose is usually 20 mg clobazam daily. If necessary, the daily dose may be increased. Generally, it is recommended that a total daily dose of 30 mg is not exceeded.
Elderly: Increased responsiveness and higher susceptibility to adverse effects may be present in elderly patients and require low initial doses and gradual dose increments under careful observation. A maintenance dose of 10 to 15 mg clobazam daily is frequently sufficient.
Children from 3 to 15 years of age: Increased responsiveness and higher susceptibility to adverse effects may be present in children and require low initial doses and gradual dose increments under careful observation. A daily dose of 5 to 10 mg clobazam is frequently sufficient. Benzodiazepines must not be given to children without careful assessment of the need for their use.
Secondary dosage adjustment: After the improvement of the symptoms, the dose may be reduced.
Timing of doses: If the dose is to be spread throughout the day, it is recommended that the larger portion be taken in the evening.
Duration of treatment: The duration of treatment must be as short as possible. The patient must be reassessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment, especially where the patient is free of symptoms. Generally, the overall duration of treatment (i.e. including tapering-of process) must not exceed 8 to 12 weeks. In certain cases, extension beyond the maximum treatment period may be necessary; treatment must not be extended without a re-evaluation of the patient's status using special expertise. It is strongly recommended that prolonged periods of uninterrupted treatment be avoided, since they may lead to dependence.
Discontinuation of treatment: It is strongly recommended that after prolonged treatment clobazam is not withdrawn suddenly but rather that the dose is reduced gradually under medical supervision; otherwise, withdrawal symptoms may occur.
+Treatment of epilepsy in combination with one or more other anticonvulsants-
+Adults and adolescents over 15 years of age: It is recommended that administration be started at small doses (5 to 15 mg daily), if necessary, increasing the dose gradually to a maximum daily dose of about 80 mg.
Children from 3 to 15 years of age: It is recommended that normally treatment be started at 5 mg daily. A maintenance dose of 0.3 to 1.0 mg/kg body weight daily is usually sufficient. Higher susceptibility to adverse effects may be present in children and require gradual dose increments under careful observation; Benzodiazepines must not be given to children without careful assessment of the need for their use.
Elderly: Higher susceptibility to adverse effects may be present in elderly patients and require low initial doses and gradual dose increments under careful observation.
Timing of doses: If the dose is spread throughout the day, it is recommended that the larger portion be taken in the evening. Doses of up to 30 mg clobazam can also be administered as a single evening dose.
Duration of treatment: The patient must be re-assessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment.
Discontinuation of treatment: At the end of treatment- to include cases in which response to therapy has been poor- it is strongly recommended that clobazam is not withdrawn suddenly but rather that the dose is reduced gradually; otherwise an increased susceptibility to seizures as well as other withdrawal symptoms may occur.","The tablets can be administered whole, or crushed and mixed in applesauce. The 10 mg tablets can be divided into equal halves of 5 mg. Clobazam can be given with or without food.
","Alcohol: Concomitant consumption of alcohol can increase the bioavailability of clobazam by 50% and therefore lead to increased clobazam effects.
Central nervous system depressant drugs: Especially when clobazam is administered in higher doses, a mutually potentiating effect is to be expected if other central nervous system depressant drugs (such as antipsychotics, anxiolytics, certain antidepressant agents, anticonvulsant drugs, sedative antihistamines, anaesthetics, hypnotics or narcotic analgesics, or other sedatives) are taken at the same time. Special caution is also necessary when clobazam is administered in cases of intoxication with such substances or with lithium.
Opioids: The concomitant use of benzodiazepines, including clobazam, and opioids increases the risk of sedation, respiratory depression, coma, and death because of the additive CNS depressant effect. Limit dosage and duration of concomitant use of benzodiazepines and opioids.
Anticonvulsants: If clobazam is administered simultaneously with anticonvulsants in the treatment of epilepsy, the dosage must be adjusted under regular medical supervision (EEG monitoring), as there may be interactions with the patient's basic anticonvulsant medication. In patients receiving concomitant treatment with valproic acid, there may be a slight to moderate rise in plasma valproic acid concentration. Phenytoin plasma levels may rise if patients receive concomitant treatment with clobazam. Where possible, it is recommended that blood levels of concomitantly administered valproic acid or phenytoin be monitored. Carbamazepine and phenytoin may cause an increase in the metabolic conversion of clobazam to the active metabolite N-desmethyl clobazam. Stiripentol increases plasma levels of clobazam and its active metabolite N-desmethylclobazam, through inhibition of CYP3A and CYP2C19. Monitoring of blood levels is recommended, prior to initiation of stiripentol, and then once new steady-state concentration has been reached, i.e. after 2 weeks approximately.
Narcotic analgesics: If clobazam is used concomitantly with narcotic analgesics, possible euphoria may be enhanced; this may lead to increased psychological dependence.
Muscle relaxants: The effects of muscle relaxants and nitrous oxide may be enhanced.
CYP 2C19 inhibitors: Strong and moderate inhibitors of CYP2C19 may result in increased exposure to N-desmethylclobazam (N-CLB), the active metabolite of clobazam. Dosage adjustment of clobazam may be necessary when co-administered with strong CYP2C19 inhibitors (e.g., cannabidiol containing medicinal products, fuconazole, fuvoxamine, ticlopidine) or moderate CYP2C19 inhibitors (e.g. omeprazole).
CYP 2D6 substrates: Clobazam is a weak CYP2D6 inhibitor. Dose adjustment of drugs metabolized by CYP2D6 (e.g. dextromethorphan, pimozide, paroxetine, nebivolol) may be necessary.
","Clobazam must not be used-
+
+- In patients with hypersensitivity to clobazam or any of the excipients of Clobazam.
+- In patients with myasthenia gravis (risk of aggravation of muscle weakness).
+- In patients with severe respiratory insufciency (risk of deterioration).
+- In patients with sleep apnoea syndrome (risk of deterioration).
+- In patients with severe impairment of liver function (risk of precipitating encephalopathy).
+- In breast-feeding women Benzodiazepines must not be given to children without careful assessment of the need for their use.
+- Clobazam must not be used in children between the ages of 6 months and 3 years, other than in exceptional cases for anticonvulsant treatment where there is a compelling indication.
+
","Metabolism and nutrition disorders: Common: decreased appetite
Psychiatric disorders: Common: irritability, aggression, restlessness, depression (pre-existing depression may be unmasked), drug tolerance (especially during prolonged use), agitation.
Nervous system disorders: Very common: somnolence, especially at the beginning of treatment and when higher doses are used; Common: sedation, dizziness, disturbance in attention, slow speech/dysarthria/ speech disorder (particularly with high doses or in long-term treatment, and are reversible), headache, tremor, ataxia.
Eye Disorders: Uncommon: diplopia (particularly with high doses or in long-term treatment and is reversible)
Respiratory, thoracic and mediastinal disorders: Not known: respiratory depression respiratory failure (particularly in patients with pre-existing compromised respiratory function e.g. in patients with bronchial asthma or brain damage)
Gastrointestinal disorders: Common: dry mouth, nausea, constipation
Skin and subcutaneous disorders: Uncommon: rash; Not known: photosensitivity reaction urticaria; Steven Johnson syndrome, toxic epidermal necrolysis (including some cases with fatal outcome);
Musculoskeleteal and connective tissue disorders: Not known: muscle spasms, muscle weakness
General disorders and administration site conditions: Very common: fatigue, especially at the beginning of treatment and when higher doses are used. Not known: slow response to stimuli, hypothermia
Investigations: Uncommon: weight increased (particularly with high doses or in long-term treatment).
","Pregnancy: Clobazam is not recommended during the first trimester of pregnancy and in women of childbearing potential not using contraception. Clobazam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have demonstrated reproductive toxicity. Clobazam crosses the placenta. In the post-marketing safety database, limited data on exposed pregnancies are available with clobazam. A large amount of data collected from cohort studies has not demonstrated evidence of the occurrence of malformations following exposure to benzodiazepines during the first trimester of pregnancy. However, in certain epidemiological case-control studies, an increased incidence of cleft lip and palate was observed with benzodiazepines. Cases of reduced fetal movement and fetal heart rate variability have been described after administration of benzodiazepines during the second and/or third trimester of pregnancy. Administration of clobazam during the late phase of pregnancy or during childbirth can result in the occurrence of neonatal respiratory depression (including respiratory distress and apnea), which may be associated with other disorders such as sedation signs, hypothermia, hypotonia, and feeding difficulties (which may result in poor weight gain) in the newborn (signs and symptoms of the so-called ""floppy infant syndrome""). Moreover, infants born to mothers who have taken benzodiazepines over longer periods during the later stages of pregnancy may have developed physical dependence and may be at risk of developing a withdrawal syndrome in the postnatal period. Appropriate monitoring of the newborn in the postnatal period is recommended. Women of childbearing potential should be informed of the risks and benefits of the use of Clobazam during pregnancy. If a woman plans a pregnancy or becomes pregnant, carefully evaluate the risks and benefits and whether treatment with Clobazam should be discontinued. If Clobazam treatment is to be continued, use Clobazam at the lowest effective dose.
Lactation: Clobazam must not be used in breastfeeding women, since clobazam passes into breast milk.
","Serious Skin Reactions: Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with clobazam in both children and adults during the post-marketing experience. A majority of the reported cases involved the concomitant use of other drugs, including antiepileptic drugs that are associated with serious skin reactions. SJS/TEN could be associated with a fatal outcome. Patients should be closely monitored for signs or symptoms of SJS/TEN, especially during the first 8 weeks of treatment. Clobazam should be immediately discontinued when SJS/TEN is suspected. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered.
Respiratory depression: Clobazam can cause respiratory depression, especially if administered in high doses. Therefore in patients with chronic or acute respiratory insufficiency, respiratory function must be monitored and a dose reduction may be necessary. Clobazam is contraindicated in patients with severe respiratory insufficiency.
Muscle weakness: Clobazam can cause muscle weakness. Clobazam is contraindicated in patients with myasthenia gravis.
Renal and hepatic impairment: In patients with impairment of renal or hepatic function, responsiveness to clobazam and susceptibility to adverse effects are increased, and a dose reduction may be necessary. In long-term treatment, renal and hepatic function must be checked regularly.
Elderly patients: In the elderly, due to the increased sensitivity to adverse reactions such as drowsiness, dizziness, muscle weakness, there is an increased risk of fall that may result in serious injury. A dose reduction is recommended.
Tolerance in epilepsy: In the treatment of epilepsy with benzodiazepines- including Clobazam, consideration must be given to the possibility of a decrease in anticonvulsant efficacy (development of tolerance) in the course of treatment.
CYP2C19 poor metabolizers: In patients who are CYP2C19 poor metabolizers, levels of the active metabolite N-desmethylclobazam are expected to be increased as compared to extensive metabolizers. Dosage adjustment of clobazam may be necessary (e.g. low starting dose with careful dose titration).
Suicidality: Several epidemiological studies show an increased incidence of suicide and suicide attempt in patients with or without depression, treated with other benzodiazepines and hypnotics. There are very limited data available for clobazam in these studies. Cases of suicidal behavior have been reported with clobazam in post-marketing surveillance. All of these cases had confounding factors.
Concomitant use of CYP2C19 inhibitors: The concomitant use of clobazam with CYP2C19 inhibitors, including cannabidiol containing medicinal products, dietary supplements and recreational products may result in increased exposure to N-desmethylclobazam (NCLB). Such increases might lead to increased adverse effects, such as somnolence and sedation. When used with medicinal products that are CYP2C19 inhibitors dosage adjustment of clobazam may be necessary. Dietary supplements and recreational products containing cannabidiol must not be taken in combination with clobazam as they contain unknown quantities of cannabidiol and are of variable quality
",,,,,"Do not use the medicine later than the date of expiry. Store below 30° and protect from light. Keep out of the reach of children.
",11
+276,Clioquinol + Flumetasone Pivalate,clioquinol-flumetasone-pivalate-276,https://medex.com.bd/attachments/rpBnPUM7a1fCh1qWNA7653Gc8fdHtE/clioquinol-flumetasone-pivalate-prescribing-information,Aural steroid & antibiotic combined preparations,Inflammation of the external ear,"This combination is indicated for the treatment of external ear inflammation and infections (otitis externa) and fungal infections of the outer ear (otomycosis).
","Aural steroid & antibiotic combined preparations, Ophthalmic steroid - antibiotic combined preparations
","Flumetasone Pivalate is a potent difluorinated glucocorticoid designed for local application. It exerts an anti-inflammatory, anti-allergic, vasoconstrictive and anti-proliferative effect. In inflammatory skin diseases of the external auditory meatus it affords prompt relief and eliminates symptoms such as pruritus and also reduces swelling.
Clioquinol is a halogenated hydroxyquinoline derivative which exerts bacteriostatic action. It is active against a broad spectrum of microorganisms including fungi (e.g., Candida, Microsporum, Trichophyton) and Gram-positive bacteria (e.g. Staphylococci). It is also effective against Gram-negative bacteria.
","For adults and children (aged 2 years and over): The recommended dose is 2 to 3 drops twice daily for the prescribed period of time (usually not longer than 10 days). Before you apply the medication, you should warm the ear drops to body temperature by holding the bottle in the palm of your hands. Do not heat it above body temperature.
",,"Topical use of Clioquinol-containing preparations may lead to a marked increase in protein-bound iodine (PBI).
","This medication is contraindicated in patients with: Punctured eardrum, Pre-existing tuberculosis of the skin, Fungal or viral infections of the skin(Chickenpox, Herpes simplex, Herpes zoster), Known hypersensitivity to corticosteroids, Iodine, Clioquinol, Flumetasone pivalate, Hydroxyquinolones or Quinolone derivatives or any of the ingredients of this formulation.
","Occasionally burning sensation, itching or skin rash may occur. Treatment should be discontinued if severe irritation or sensitization develops.
","Pregnancy: No reports of adverse effects in human pregnancy have been received to date. However, when using this product in pregnancy, the risk-benefit relationship should be carefully considered.
Lactation: It is not known whether Flumetasone Pivalate or Clioquinol passes into breast milk. Caution should be exercised when Flumetanol is administered to a nursing mother.
","Prior to the beginning of therapy, the ear-drum should be checked by the physician. If there is a risk that perforation of the ear-drum may occur, this ear drops should not be used. If no improvement occurs within about 1 week, the therapy should be discontinued. It is then advisable to identify the pathogens and to institute an appropriate treatment. This ear drop should not be allowed to come in contact with the conjunctiva.
","Children under 2 years of age is contraindicated.
","Application to extensive or eroded areas of skin may lead to increased PBI values within 1 week. If signs and symptoms resembling those of thyrotoxicosis occur, the preparation should be withdrawn at once.
",,,"Keep out of the reach of children. Store in a cool, dry place, away from heat and direct light. Do not use more than 4 weeks after opening.
",12
+275,Clindamycin + Tretinoin,clindamycin-tretinoin-275,https://medex.com.bd/attachments/QAAsLhZDVKMgTUh7a8TQZ08d4S3xS8/clindamycin-tretinoin-prescribing-information,Topical antibiotic & retinoid preparations,Acne vulgaris,"Clindamycin and Tretinoin gel is indicated for the topical treatment of Acne vulgaris.
","Topical antibiotic & retinoid preparations
","This is a combination of lincosamide antibiotic Clindamycin phosphate and retinoid Tretinoin. Clindamycin binds with the 50s ribosomal subunit of susceptible bacteria and prevents elongation of peptide chain by interfering with the peptidyl transfer, thereby suppressing bacterial protein synthesis. Clindamycin inhibits the activity of Propionibacterium acne as reduces the occurrence of acne. Tretinoin decreases the cohesiveness of follicular epithelial cells and increases the turn over thereby brings the comedones out.
","Before sleep: Wash the face gently with a mild soap and water, then pat the skin dry. Apply the Gel with finger tips through the face gently.
In the morning: Apply a sunscreen after the application of Gel. Do not wash your face more than 2 or 3 times a day. Apply the sunscreen cream as needed.
Safety and effectiveness in children below 12 years of age have not been established.
",,"
+- Concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, products with high concentrations of alcohol, astringents, spices or lime) should be approached with caution.
+- While using concomitantly with Erythromycin, the activity of both Clindamycin and Erythromycin are decreased. So, Clindamycin should not be used with Erythromycin concomitantly.
+- While using concomitantly with neuromuscular medicine, the activity of the neuromuscular medicine is increased. So, care should be taken during these concomitant uses.
+
","Clindamycin and Tretinoin should not be administered to individuals who are hypersensitive to Clindamycin or Tretinoin or any other component of the Gel.
","Erythema, scaling, nasopharyngitis, dry skin, cough, sinusitis and diarrhea are the common side effects.
","It is not known whether Clindamycin or Tretinoin is excreted in human milk. Exercise special caution while applying Clindamycin or Tretinoin to a nursing mother.
","Clindamycin and Tretinoin should not be applied to eyes, nose, ear, lips, cut, burn and other infections. After the application of the Gel, keep away from sunlight.
",,,,,"Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+274,Clindamycin + Benzoyl peroxide,clindamycin-benzoyl-peroxide-274,https://medex.com.bd/attachments/4jkZgZt69Lpkd6o0WxY1siYGGjbpqY/clindamycin-benzoyl-peroxide-prescribing-information,"Benzoyl peroxide, Azelaic acid & other preparations",Acne vulgaris,"Indicated in acne vulgaris.
","Benzoyl peroxide, Azelaic acid & other preparations
","Clindamycin is a semi-synthetic derivative of lincomycin. It inhibits bacterial protein synthesis by reversibly binding to the 50S ribosomal subunits thus blocking the transpeptidation or translocation reactions of susceptible organisms.
Benzoyl peroxide has mild keratolytic effect and antimicrobial activity which is attributed to its potent oxidizing activity. Clindamycin and Benzoyl peroxide are both active against Propionibacterium acnes, an organism associated with acne vulgaris.
","Apply to the affected areas once or twice daily (morning and evening) after the skin is gently washed and patted dry.
",,"May enhance the action of neuromuscular blocking agents (e.g. atracurium). May antagonise the effects of parasympathomimetics. May competitively inhibit the effects of macrolides, ketolides, streptogramins, linezolid and chloramphenicol. Increased coagulation tests (prothrombin time/INR) and/or bleeding with vit K antagonists (e.g. warfarin, acenocoumarol, fluindione). PABA sunscreens may transiently discolour fabric.
","Hypersensitivity to Clindamycin, lincomycin, benzoyl peroxide, or any component of the formulation; history of regional enteritis, ulcerative colitis, pseudomembranous colitis or antibiotic-associated colitis.
","Application site pain, Application site exfoliation, Application site irritation, Erythema, Burning, Pruritus, Sunburn, Scaling, Drynes, Colitis, Peelin.
","Pregnancy Category- C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Lactation: Excretion in milk is unknown/ not recommended
","Avoid contact with mouth, eyes, lips & mucous membranes; abraded or eczematous skin. May discolor hair & dyed fabrics. Pregnancy & lactation.
",,,,"Refer to individual product recommendations. Some combination products require reconstitution at the time of dispensing by dissolving the Clindamycin powder with purified water, add the solution to the Benzoyl peroxide gel provided and stir until the gel appears homogenous.
",,10
+1834,Clindamycin (Vaginal Cream),clindamycin-vaginal-cream-1834,https://medex.com.bd/attachments/QFbefIfAAmOmWvWLmUFV8Nd416pWxz/clindamycin-vaginal-cream-prescribing-information,Macrolides,Bacterial vaginosis,"Clindamycin cream is indicated in the treatment of bacterial vaginosis. Clindamycin cream can be used to treat non pregnant women and pregnant women during the second and third trimester.
","Macrolides
","Clindamycin Phosphate is a water soluble ester that derived from the parent antibiotic Lincomycin. Clindamycin inhibits bacterial protein synthesis by binding preferentially to the 50s ribosomal subunit and affects the process of peptide chain initiation. In vitro Clindamycin is active against most strains of the following organisms that have been reported to be associated with bacterial vaginosis:
+
+- Bacteroides spp.
+- Gardnerella vaginalism
+- Mobiluncus spp.
+- Mycoplasma hominis
+- Peptostreptococcus spp.
+
","One applicator full (approximately 5 gram) intravaginally at bedtime for 7 consecutive days. In patients in whom a shorter treatment course is desirable, a 3-day regimen has been shown to be effective.
",,,"Clindamycin cream is not recommended in children under 12 years of age.
","Clindamycin may results the following side effects. Genital tract: vaginitis, vulvo-vaginal irritation Central nervous system: dizziness, headache, vertigo.Gastro-intestinal: heartburn, nausea, vomiting, diarrhea, constipation, abdominal pain. Dermatological: rash, exanthema. Hypersensitivity: urticaria.
","There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. This drug should be used during the first trimester of pregnancy only if clearly needed. There is no restriction to use Clindamycin cream during the second and third trimester. It is not known if clindamycin is excreted in breast milk following the use of vaginally administered Clindamycin phosphate. However, orally and parenterally administered Clindamycin has been reported to appear in breast milk.
","The patient should be instructed not to engage in vaginal intercourse, or use other vaginal products during treatment with this product. This cream contains mineral oil that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. Therefore, use of such products within 72 hours following treatment with Clindamycin cream is not recommended.
",,"Intravaginal overdose is not possible. Accidental ingestion of the product could be accompanied by effects related to therapeutic levels of oral clindamycin.
",,,"Store the tube below 25 °C, away from light & moisture. Keep out of the reach of children.
",10
+1588,Clindamycin (Lotion),clindamycin-lotion-1588,https://medex.com.bd/attachments/6fONSnVwRprUWQ7iNlktN623qGSigK/clindamycin-lotion-prescribing-information,Macrolides,Bacterial vaginosis,"Clindamycin lotion is indicated in the treatment of acne vulgaris. Other uses of topical Clindamycin lotion are:
+
+- Skin infections such as erythrasma caused by Corynebacterium minutissimum; rosacea, periorificial dermatitis, folliculitis, stasis, chronic lymphaedema and familial pemphigus.
+- Dermal ulcers.
+
","Macrolides
","Clindamycin is a lincosamide antibiotic used in the treatment of infections caused by susceptible microorganisms. Clindamycin is a semisynthetic antibiotic derived from lincomycin. It has antiacne and antibacterial activity. It binds with the 50s subunit of the bacterial ribosome and inhibits the early stage of protein synthesis. It is highly potent against gram positive and anaerobic bacteria.
Microbiology: Aerobic gram-positive cocci, including: Staphylococcus aureus, Staphylococcus epidermidis (penicillinase and non-penicillinase producing strains), Streptococci, Pneumococci. Anaerobic gram-negative bacilli, including: Bacteroides species, Fusobacterium species. Anaerobic gram-positive non-spore forming bacilli, including: Propionibacterium species, Eubacterium species, Actinomyces species. Anaerobic and microaerophilic gram-positive cocci, including: Peptococcus species, Peptostreptococcus species, Microaerophilic streptococci, C. perfringes
","At first, wash the face or affected area gently with warm water or soap. When the skin is completely dried (about 30 minutes later) apply a thin film of Clindamycin lotion to the entire affected area twice daily. The Applied area should not be washed within 3 hours. Noticeable improvement is usually seen after about 6 weeks. However, 8 to 12 weeks of treatment may be required for maximum benefit. Eye, lip or nose contact should be avoided while applying Clindamycin lotion.
",,"Clindamycin enhances the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.
",,"Side effects are usually rare. Possible side-effects may includes skin rash, itching, oily skin, dryness, erythema, burning, change in skin color, diarrhea, colitis, GI disturbance etc.
","There is no adequate data for safe use in pregnancy. Animal studies showed no adverse effects on the fetus. It is not known that whether Clindamycin is excreted through breast milk following topical administration. However, Clindamycin lotion can be used during lactation with caution.
","Clindamycin lotion is not for oral, ophthalmic, or Intravaginal use. Avoid exposure to sunlight and sunlamps. Wear sunscreen daily.
",,"Intravaginal overdose is not possible. Accidental ingestion of the product could be accompanied by effects related to therapeutic levels of oral clindamycin.
",,,"Store the tube below 25 °C, away from light & moisture. Keep out of the reach of children.
",10
+273,Clindamycin,clindamycin-273,https://medex.com.bd/attachments/coL9w2M3pJEZ1RgJXe2S182W1UDhUG/clindamycin-oral-solution-prescribing-information,Macrolides,Toxic shock syndrome,"Clindamycin has been shown to be effective in the treatment of the following infections when caused by susceptible anaerobic bacteria or susceptible strains of gram positive bacteria such as Streptococci, Staphylococci and Pneumococci; Upper respiratory infections, Lower respiratory infections, Skin ... Read more
Clindamycin has been shown to be effective in the treatment of the following infections when caused by susceptible anaerobic bacteria or susceptible strains of gram positive bacteria such as Streptococci, Staphylococci and Pneumococci; Upper respiratory infections, Lower respiratory infections, Skin and soft tissue infections, Bone and joint infections, Pelvic infections, Intra-abdominal infections, Septicemia and endocarditis, Dental infections. As an alternative therapy when used in combination with quinine or amodiaquine for the treatment of multi-drug resistant Plasmodium falciporum infection.
","Macrolides
",,"Dosage of Clindamycin Capsule:
+
+- Serious Infections: 150 mg-300 mg every six hours.
+- More severe infections: 300 mg-450 mg every six hours.
+
+To avoid the possibility of oesophageal irritation, Clindacin capsules should be taken with a full glass of water.
Several researches has found that Clindamycin 300 mg capsule provides plasma concentration over MIC
90 for more than 12 hours. This finding supports the twice-daily dosing of Clindacin 300 mg capsule, particularly in SSTIs & RTIs. However, in case of bone & joint infections, diabetic foot infections dose of Clindamycin should be 300 mg capsule 3-4 times daily.
Dosage of Clindamycin Powder for oral solution:
+
+- Serious infections: 8-12 mg/kg/day divided into 3 or 4 equal doses.
+- Severe infections: 13-16 mg/kg/day divided into 3 or 4 equal doses.
+- More severe infections: 17-25 mg/kg/day divided into 3 or 4 equal doses.
+
+In pediatric patients weighing 10 kg or less, 1/2 teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose.
Dosage of Clindamycin IV/IM Injection:
Adults-
+
+- Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes: 600-1200 mg/day in 2- 4 equal doses.
+- More severe infections: 1200-2700 mg/day in 2-4 equal doses.
+- For more serious infections: these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes, these doses may be increased.
+- Doses of as much as 4800 mg daily have been given intravenously to adults. Single intramuscular injections of greater than 600 mg are not recommended.
+
+Neonates (less than 1 month): 15 to 20 mg/kg/day in 3 to 4 equal doses. The lower effective dosage may be adequate for small prematures.
Pediatric patients (1 month of age to 16 years):
+
+- 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections.
+- Parenteral therapy may be changed to Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.
+- In cases of (3-hemolytic streptococcal infections, treatment should be continued for at least 10 days.
+
",,"Clindamycin enhances the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.
","Clindamycin is contraindicated in patients previously found to be sensitive to clindamycin or any of the ingredients of this medicine.
","The adverse effects have been reported with the use of clindamycin are- abdominal pain, oesophagitis and oesophagial ulcer, nausea, vomiting and diarrhoea, pruritus, skin rashes, urticaria.
","Pregnancy Category B. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal concentrations. Clindamycin should be used in pregnancy only if clearly needed. Clindamycin has been reported to appear in breast milk. Therefore, it is not recommended for nursing mothers if not clearly needed.
","Clindamycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
","Use in newborns and infants: When Clindamycin is administered to newborns and infants (birth to 16 years), appropriate monitoring of organ system functions is desirable.
Geriatric use: Dose adjustment of Clindamycin is not necessary.
","Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Overdosage should be treated with simple gastric lavage. No specific antidote is known.
",,"Direction for reconstitution (powder for oral solution): Shake the bottle well to loosen the powder. Add 80 ml of boiled and cooled water to the dry mixture in the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in solution. Keep the bottle tightly closed. The reconstituted solution should be used within 2 weeks if kept at room temperature.
Dilution of Clindamycin injection for intravenous use: Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml. Infusion rates should not exceed 30 mg per minute.
+
+- Administration of more than 1200 mg in a single 1 hour infusion is not recommended.
+- Single IM injections of greater than 600 mg are not recommended. Dilution is not required for intramuscular administration.
+- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
+
+
Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of Clindamycin phosphate Sterile Solution (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.
Physico-Chemical Stability of diluted solutions of Clindacin Injection-
+
+- Room temperature: 16 days at 25°C.
+- Refrigeration: 32 days at 4°C.
+
","Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+1877,Conjugated Estrogen + Bazedoxifene,conjugated-estrogen-bazedoxifene-1877,https://medex.com.bd/attachments/BeoN7hefJyu51nRtyy3ANfFnAlxvzL/conjugated-estrogen-bazedoxifene-prescribing-information,Female Sex hormones,Osteoporosis,"This is a combination of conjugated estrogens with an estrogen agonist/antagonist indicated for treatment of the following conditions in women with a uterus:
+
+- Treatment of moderate to severe vasomotor symptoms associated with menopause
+- Prevention of postmenopausal osteoporosis
+
","Female Sex hormones
","This tablet pairs conjugated estrogens with bazedoxifene. Conjugated estrogens and bazedoxifene function by binding to and activating estrogen receptors (ER) α and β, which vary in proportion from tissue to tissue. Conjugated estrogens are composed of multiple estrogens and are agonists of ER- α and β. Bazedoxifene is an estrogen agonist/antagonist that acts as an agonist in some estrogen-sensitive tissues and an antagonist in others (e.g., uterus). The pairing of conjugated estrogens with bazedoxifene produces a composite effect that is specific to each target tissue. The bazedoxifene component reduces the risk of endometrial hyperplasia that can occur with the conjugated estrogens component.
",,,"No drug interaction studies were conducted with This tablet. Estrogens are metabolized partially by CYP3A4. Concomitant use of this tablet with CYP3A4 inhibitors may increase the exposure of conjugated estrogens and thereby may increase the risk of endometrial hyperplasia.
","
+- Undiagnosed abnormal uterine bleeding
+- Known, suspected, or past history of breast cancer
+- Known or suspected estrogen-dependent neoplasia
+- Active or past history of venous thromboembolism
+- Active or past history of arterial thromboembolism
+- Hypersensitivity (angioedema, anaphylaxis) to estrogens, bazedoxifene, or any ingredients
+- Known hepatic impairment or disease
+- Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders
+- Pregnancy, women who may become pregnant, and nursing mothers
+
","In four prospective, randomized, placebo-controlled trials the common adverse reactions (incidence ≥5%) were muscle spasms, nausea, diarrhea, dyspepsia, abdominal pain upper, oropharyngeal pain, dizziness, and neck pain.
","Pregnancy Category X. This tablet must not be used in women who are or may become pregnant. No studies were performed on animals to evaluate the effects on reproduction with conjugated estrogens/bazedoxifene. This tablet should not be used by lactating women. It is not known whether this drug is excreted in human milk. Detectable amounts of estrogens have been identified in the milk of mothers receiving conjugated estrogens. Estrogen administration to nursing mothers has been shown to decrease the quantity and quality of the milk
","
+- Women taking this tablet should not take progestins, additional estrogens or additional estrogen agonist/antagonists
+- Cardiovascular disorders, including venous thromboembolism, pulmonary embolism, stroke, and retinal vascular thrombosis
+- Malignant neoplasms, including endometrial cancer, breast cancer, and ovarian cancer
+- Estrogens increase the risk of gallbladder disease
+- Discontinue estrogen if loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs
+- Monitor thyroid function in women on thyroid replacement therapy
+
","Pediatric Use: This tablet is not indicated for use in children.
Geriatric Use: This tablet was not studied in women aged 75 or older; use in this population is not recommended. An increased risk of probable dementia in women over 65 years of age was reported in the Women’s Health Initiative Memory ancillary studies of the Women’s Health Initiative.
Renal Impairment: This tablet was not studied in women with renal impairment; use in this population is not recommended.
Body Mass Index: Women with BMI >27 kg/m 2 may have an increased risk of endometrial hyperplasia.
","In case of overdosage, there is no specific antidote, and the treatment should be symptomatic. Symptoms of overdosage of estrogen-containing products in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding may occur.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+304,Conjugated Estrogen (Tablet),conjugated-estrogen-tablet-304,https://medex.com.bd/attachments/CNXJkGOSifjDLS3h3BEXPXMM5s7VWC/conjugated-estrogen-tablet-tablets-prescribing-information,Female Sex hormones,Vaginal dryness,"Conjugated Estrogens vaginal cream is indicated in the treatment of atrophic vaginitis, dyspareunia and kraurosis vulvae. Conjugated Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia.
","Female Sex hormones
","Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic equilibrium of metabolic interconversions, estradiol is the principal intracellular human estrogen and is substantially more potent than its metabolites, estrone and estriol, at the receptor level.
The primary source of estrogen in normally cycling adult women is the ovarian follicle, which secretes 70 to 500 mcg of estradiol daily, depending on the phase of the menstrual cycle. After menopause, most endogenous estrogen is produced by conversion of androstenedione, which is secreted by the adrenal cortex, to estrone in the peripheral tissues. Thus, estrone and the sulfate-conjugated form, estrone sulfate, are the most abundant circulating estrogen in postmenopausal women.
Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. To date, two estrogen receptors have been identified. These vary in proportion from tissue to tissue. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and follicle stimulating hormone (FSH), through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these gonadotropins seen in postmenopausal women.
","Menopausal vasomotor symptoms: 0.45 mg/day, up to 1.25 mg/day. Attempt to discontinue medication at 3-6-mth intervals.
Vulvular and vaginal atrophy: 0.3 mg/day.
Female hypogonadism: 0.3-0.625 mg/day in a cyclical regimen. Add progestin treatment once skeletal maturity is achieved.
Female castration, Primary ovarian failure: 1.25 mg/day in a cyclical regimen. Palliation in prostate carcinoma 1.25-2.5 mg 3 times/day.
Osteoporosis prophylaxis in postmenopausal women: Initial: 0.3 mg/day in a cyclical or continuous regimen depending on patient's condition.
",,"The metabolism of estrogens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes, such as anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz).
Ritonavir and nelfinavir, although known as strong inhibitors, by contrast exhibit inducing properties when used concomitantly with steroid hormones.
","Known or suspected pregnancy; undiagnosed abnormal uterine bleeding; known, suspected, or history of past breast cancer; known or suspected estrogen-dependent neoplasia (e.g., endometrial cancer, endometrial hyperplasia); active or history of arterial thromboembolic disease (e.g., stroke, myocardial infarction or venous thromboembolism (such as deep venous thrombosis, pulmonary embolism); active or chronic liver dysfunction or disease; known thrombophilic disorders (e.g., protein C, protein S, or antithrombin deficiency); hypersensitivity to any component of this medication.
","Breast pain, tenderness or enlargement, Headache/migraine, Gut disturbances, such as nausea, abdominal pain, bloating, flatulence, indigestion, Legcramps, Fatigue, Weightchanges, Vaginalthrush, Depression, Anxiety, Dizziness, Changes in sex drive, Rise in blood pressure, Gall bladder disease, Swelling of the ankles due to to fluid retention (peripheral oedema), Skin reactions such as rash and itch, Steepening of corneal curvature which may make contact lenses uncomfortable, Premenstrual-like symptoms, Disturbance in liver function, Irregular brown patches on the skin, usually of the face (chloasma), Blood clots in the blood vessels.
","For women with a uterus: If pregnancy occurs during medication with Conjugated Oestrogens treatment should be withdrawn immediately. The results of most epidemiological studies to date relevant to inadvertent foetal exposure to estrogens indicate no teratogenic or foetotoxic effects.
Lactation: Conjugated Oestrogens is not indicated during lactation.
","Asthma, epilepsy, migraine; heart or kidney dysfunction; CV disease; cerebrovascular disorders; diabetes, hypercalcaemia; gall bladder disease; porphyria. Children. Lactation.
Lactation: Use controversial; estrogens are excreted into breast milk in small quantities; use with caution
",,"Symptoms of overdosage of estrogen containing products in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment if necessary should be symptomatic.
",,,"Do not store above 25° C. Store at room temperature.
",11
+1780,Conjugated Estrogen (Cream),conjugated-estrogen-cream-1780,,Female Sex hormones,Vaginitis,"Conjugated Estrogen cream is indicated in the following indications-
+
+- Moderate-to-severe vasomotor symptoms associated with estrogen deficiency.
+- Prevention and management of osteoporosis associated with estrogen deficiency.
+- Atrophic vaginitis and Kraurosis Vulvae.
+- Female hypoestrogenism.
+- Treatment of moderate to severe Dyspareunia.
+
","Female Sex hormones
","Estrogens are important in the development and maintenance of the female urogenital system and secondary sex characteristics. They promote growth and development of the vagina, uterus, and fallopian tubes, and enlargement of the breasts. Indirectly, they contribute to the shaping of the skeleton, maintenance of tone and elasticity of urogenital structures, changes in the epiphyses of the long bones associated with the pubertal growth spurt and its termination, growth of axillary and pubic hair, and pigmentation of the nipples and genital tissues. However, in the preovulatory or anovulatory cycle, estrogen is the primary determinant in the onset menstruation. Eestrogen also affects the release of pituitary gonadotropins. The pharmacologic effects of conjugated estrogens are similar to those of endogenous estrogens. In responsive tissues (female urogenital organs, breasts, hypothalamus, pituitary) estrogens enter the cell and are transported into the nucleus. As a result of estrogenic activity, specific RNA and protein synthesis occurs.
Osteoporosis associated with estrogen deficiency: Estrogen replacement therapy is the most effective single modality for the prevention of osteoporosis (loss of bone mass) in postmenopausal women. Estrogen reduces bone resorption and retards or halts postmenopausal bone loss. One clinical study demonstrated that even when estrogen was started as late as fifteen years after menopause, further loss of bone mass was prevented but no restoration of bone mass was observed. The effect on bone mass conservation is sustained only as long as conjugated estrogen therapy is continued. Different ethnic groups are at different risk for osteoporosis.
Atrophic vaginitis and Kraurosis Vulvae: Atrophic vaginitis and Kraurosis Vulvae associated with estrogen deficiency. In the absence of estrogen stimulation, the vulvar and vaginal tissues shrink, the vaginal walls become thin and dry, and rugal folds disappear. Tenderness and pruritus, with resulting dysuria and dyspareunia, may occur. Fissures and ulcerations of tissue with spotting or bleeding may result from coitus. These changes are reversible with the administration of estrogen replacement therapy.
Female Hypoestrogenism: Estrogen replacement therapy is indicated in hypoestrogenism related to female hypogonadism or primary ovarian failure. Primary ovarian failure starting early in life will lead to delayed closure of the epiphyses and retarded bone maturation. Long term estrogen deficiency in any age group will usually lead to osteoporosis (for efficacy with estrogen replacement therapy see osteoporosis). Estrogen therapy is associated with the appearance of female characteristics in these patients.
","Atrophic Vaginitis and Kraurosis Vulvae: Administer cyclic regimen (daily for 21 days followed by 7 days off) intravaginally. Start at 0.5 gm dosage strength; may adjust dosage (0.5 to 2 gm) based on individual response.
Moderate to Severe Dyspareunia: Treats symptom of vulvar and vaginal atrophy due to menopause 0.5 gm intravaginally in a twice-weekly (eg, Monday and Thursday) continuously or in a cyclic regimen of daily administration for 21 days followed by 7 days off.
","Step 1: Remove cap from tube.
Step 2: Screw nozzle end of applicator onto tube.
Step 3: Gently squeeze tube from the bottom to force sufficient cream into the barrel to provide the prescribed dose.
Step 4: Unscrew applicator from tube.
Step 5: Place the applicator into the vaginal opening.
Step 6: To deliver medication, press plunger downward.
To cleanse: Pull plunger to remove it from barrel. Wash with mild soap and warm water. Do not boil.
","Rifampin reportedly decreases estrogenic activity during concomitant use with estrogen. This effect has been attributed to enhanced metabolism of estrogen, presumably by induction of hepatic microsomal enzymes.
","
+- Known or suspected cancer of the breast.
+- Known or suspected estrogen-dependent neoplasia.
+- Known or suspected pregnancy.
+- Undiagnosed abnormal genital bleeding.
+- Active thrombophlebitis or thromboembolic disorders.
+- Hypersensitivity to any of the components of Conjugated Estrogen vaginal cream.
+
","The most serious adverse reactions associated with the use of estrogen are indicated under Warnings and Precautions. The following additional adverse reactions have been reported with estrogenic therapy.
+
+- Genitourinary System: Breakthrough bleeding, spotting, change in menstrual flow, amenorrhea.
+- Breasts: Tenderness, enlargement, secretion.
+- Gastrointestinal: Nausea, vomiting, abdominal cramps, bloating, cholestatic jaundice.
+- Skin: Chloasma or melasma which may persist when drug is discontinued, alopecia, rash.
+- Eyes: Steepening of the corneal curvature; intolerance to contact lenses.
+- Central Nervous System: Headache, migraine, dizziness; chorea.
+- Miscellaneous: Increase or decrease in weight; edema; changes in libido, aggravation of porphyria.
+
+Common side effects include Headache, Breast pain, Irregular vaginal bleeding or spotting, stomach or abdominal cramps, bloating, Nausea and vomiting, Hair loss, Fluid retention, Vaginal yeast infection, Reactions from inserting Conjugated Estrogen Vaginal Cream, such as vaginal burning, irritation and itching.
Uncommon side Effects Heart attack, Stroke, Blood clots, Dementia, Breast cancer, Cancer of the lining of the uterus (womb), Cancer of the ovary, High blood pressure, High blood sugar, Gallbladder disease, Enlargement of benign tumors of the uterus
(fibroids), Severe allergic reaction.
","Estrogen should not be used during pregnancy. Estrogen therapy during pregnancy is associated with an increased risk of congenital defects in the reproductive organs of the male and female fetus, an increased risk of vaginal adenosis, squamous cell dysplasia of the cervix, and vaginal cancer in the female later in life. There is no indication for estrogen therapy during pregnancy. Estrogens are effective in the prevention or treatment of threatened or habitual abortion.
As a general principle, the administration of any drug to nursing mothers should be done only when clearly necessary since many drugs are excreted in human milk.
","Estrogen therapy without the addition of a progestogen in women with a uterus has been reported to increase the risk of endometrial hyperplasia/carcinoma. The risk appears to depend on both duration of treatment and estrogen dose. The patient should be reassessed at least on an annual basis. Studies have indicated a reduced risk of endometrial cancer when a progestogen is administered with estrogen replacement therapy. There are possible additional risks which may be associated with the inclusion of a progestogen in hormone replacement therapy regimens. These include adverse effects on carbohydrate and lipid metabolism. An increased risk of gallbladder disease in women receiving postmenopausal estrogen has been reported. Some studies have suggested a possible increased incidence of breast cancer in those women on estrogen therapy taking higher doses for prolonged periods of time. Women on this therapy should have regular breast examinations and should be instructed in breast self-examination. Doses of Conjugated Estrogen used should not exceed the recommended doses.
A complete medical and family history should be obtained prior to the initiation of any estrogen therapy. The pretreatment and periodic physical examinations should include special reference to blood pressure, breasts, abdomen, and pelvic organs, and should include a Papanicolaou smear. Where no pathologic cause is found for abnormal vaginal bleeding, dose reduction of cycling may be indicated. Women on estrogen replacement therapy have not been reported to have an increased risk of thrombophlebitis and/or thromboembolic disease. However, there is insufficient information regarding women who have a history of thromboembolic disease to determine risk. Estrogen may be poorly metabolized in patients with impaired liver function and they should be administered with caution in such patients.
",,"Overdosage of estrogen may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of Conjugated Estrogen therapy with institution of appropriate symptomatic care.
",,,"Store in a cool (below 30°C) and dry place, protected from light and moisture.
",12
+1429,Colistimethate Sodium,colistimethate-sodium-1429,https://medex.com.bd/attachments/z9BcrJe17HR2X9UgBpqPSKOFq0kCC3/colistimethate-sodium-prescribing-information,Other antibacterial preparation,Bacterial infections,"Colistimethate is indicated for the treatment of acute or chronic infections caused by sensitive strains of certain gram-negative bacilli. It is particularly indicated in the infection caused by sensitive strains of Pseudomonas aeruginosa. Colistimethate is not indicated for infections due to Proteus ... Read more
Colistimethate is indicated for the treatment of acute or chronic infections caused by sensitive strains of certain gram-negative bacilli. It is particularly indicated in the infection caused by sensitive strains of Pseudomonas aeruginosa. Colistimethate is not indicated for infections due to Proteus or Neisseria. Colistimethate is very effective in the treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa.
","Other antibacterial preparation
","Colistimethate is a surface active agent which penetrates into and disrupts the bacterial cell membrane. Colistimethate is polycationic and has both hydrophobic and lipophilic moieties. It interacts with the bacterial cytoplasmic membrane, changing its permeability. This effect is bactericidal. There is also evidence that polymyxins enter the cell and precipitate cytoplasmic components, primarily ribosomes.
","Maintenance dose: 9 MIU/day in 2-3 divided doses. In patients who are critically ill, a loading dose of 9 MIU should be administered.
Renal impairment patients: Dose adjustments in renal impairment patients are necessary. Dose reductions are recommended for patients with creatinine clearance < 50 ml/min. Twice daily dosing is recommended.
+
+- Creatinine clearance <50-30 ml/min: daily dose 5.5-7.5 MIU
+- Creatinine clearance <30-10 ml/min: daily dose 4.5-5.5 MIU
+- Creatinine clearance <10 ml/min: daily dose 3.5 MIU
+
+Haemodialysis (HD) patients:
+
+- No-HD days: 2.25 MIU/day (2.2-2.3 MIU/day).
+- HD days: 3 MIU/day (Should be given after the HD session) Twice daily dosing is recommended.
+
+
Pediatric population: The dose should be based on lean body weight.
+
+- Children ≤40 kg: 75,000-150,000 IU/kg/day divided into 3 doses.
+- Children >40 kg: >150,000 IU/kg/day has been reported in children with cystic fibrosis.
+
+
Hepatic impairment patients: There are no data in patients with hepatic impairment. Caution is advised when administering colistimethate sodium in these patients.
","Direct Intermittent Administration- Slowly inject one-half of the total daily dose over a period of 3 to 5 minutes every 12 hours.
Continuous Infusion- Slowly inject one-half of the total daily dose over 3 to 5 minutes. Add the remaining half of the total daily dose of Colistimethate for injection to one of the following:
+
+- 0.9% NaCl
+- 5% dextrose in 0.9% NaCl
+- 5% dextrose in water
+- 5% dextrose in 0.45% NaCl
+- 5% dextrose in 0.225% NaCl
+- Lactated Ringer's solution
+
+There are not sufficient data to recommend usage of Colistimethate for injection with other drugs or other than the above listed infusion solutions. Administer the second half of the total daily dose by slow intravenous infusion, starting 1 to 2 hours after the initial dose, over the next 22 to 23 hours. In the presence of impaired renal function, reduce the infusion rate depending on the degree of renal impairment. The choice of intravenous solution and the volume to be employed are dictated by the requirements of fluid and electrolyte management. Any infusion solution containing Colistimethate sodium should be freshly prepared and used for no longer than 24 hours.
Alternative method- As per specialized references for intermittent infusion: Prescribed dose can be diluted in 50-100 ml 0.9% NaCl and administer over 30-60 minutes in IV route.
","Colistimethate should not be given with certain antibiotics like- aminoglycosides and polymyxin due to report of interfere with the nerve transmission at the neuromuscular junction. It should not be given with muscle relaxants e.g., tubocurarine and other drugs including ether, succinylcholine, gallamine, decamethonium and sodium citrate. The concomitant use of Sodium Cephalothin and Colistimethate should be avoided.
","The use of Colistimethate Sodium Parenteral is contraindicated for patients with a history of sensitivity to the drug or any of its components.
","The following adverse reactions have been reported: gastrointestinal upset, tingling of extremities and tongue, slurred speech, dizziness, vertigo and paresthesia, generalized itching, urticaria and rash, fever, increased blood urea nitrogen (BUN), elevated creatinine and decreased creatinine clearance, respiratory distress and apnea, nephrotoxicity and decreased urine output.
","There are no adequate and well-controlled studies about the use of Colistimethate in pregnant women. Since colistimethate is transferred across the placental barrier in humans, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Colistimethate is excreted in human breast milk. Therefore, caution should be exercised when administered to nursing women.
","Colistimethate should be used with caution in patient with impaired renal function. When actual renal impairment is present, Colistimethate may be used, but the greatest caution should be exercised and the dosage should be reduced in proportion to the extent of the impairment. Colistimethate should be used with caution in neonates, infants and children.
",,"Overdosage with colistimethate sodium can cause neuromuscular blockade characterized by paresthesia, lethargy, confusion, dizziness, ataxia, nystagmus, disorders of speech and apnea. Respiratory muscle paralysis may lead to apnea, respiratory arrest and death. Overdosage with the drug can also cause acute renal failure, manifested as decreased urine output and increases in serum concentrations of B.U.N and creatinine. As in any case of overdose, Colistimethate Sodium therapy should be discontinued and general supportive measures should be utilized.
",,"For IM injection: Reconstitute the contents of the vial with 2 ml water for injection only.
For bolus injection: Reconstitute the contents of the vial with 5 ml water for injection.
For infusion: The contents of the reconstituted vial may be diluted, usually with 50 ml-100ml 0.9% sodium chloride.
","Before reconstitution: Store below 30°C. After reconstitution: Store at 2°C to 8°C (Do not freeze) and use within 24 hours.
",13
+252,Colecalciferol [Vitamin D3],colecalciferol-vitamin-d3-252,https://medex.com.bd/attachments/f9Y3oo4zJQIQ2XVRUhh4KkAgPaaXwJ/colecalciferol-vitamin-d3-capsules-prescribing-information,Vitamin in bone formation,Rickets,"Colecalciferol (Vitamin D3) is indicated in the treatment & prevention of Vitamin D3 deficiency. It is also indicated as an adjunct to specific therapy for osteoporosis, osteomalacia, hypocalcaemia, tetany and rickets in patients with vitamin D3 deficiency. Cholecalciferol, synthetic form of Vitamin-D ... Read more
Colecalciferol (Vitamin D3) is indicated in the treatment & prevention of Vitamin D3 deficiency. It is also indicated as an adjunct to specific therapy for osteoporosis, osteomalacia, hypocalcaemia, tetany and rickets in patients with vitamin D3 deficiency. Cholecalciferol, synthetic form of Vitamin-D which is essential for normal bone growth and development and to maintain bone density. It is also necessary for utilization of both calcium and Phosphorus. Babies need Vitamin-D3 for healthy growth & development. It acts as a hormone.
","Vitamin in bone formation, Vitamin-D preparations
","Colecalciferol (Vitamin D3) helps for the absorption & reabsorption of Calcium & Phosphorous. Vitamin D3 is essential for normal bone growth & to maintain bone density. It also reduces the severity of bacterial infection, improves lung function, prevents the risk of cancer (breast, colorectal) & helps to maintain adequate insulin levels for type 2 diabetes patients.
","For capsule: Adults:
+
+- Treatment of Vitamin D3 deficiency: 40000 IU once weekly for 7 weeks. Doses for maintenance therapy is 1400-2000 IU/day. To confirm the target level of 25 hydroxyvitamin D, measurement of it should be determined 3-4 months after initiating the maintenance therapy.
+- Prevention of Vitamin D3 deficiency: 20000 IU every 4 weeks. Higher doses may be required in certain situations.
+- Addition to specific therapy for osteoporosis: 20000 IU once a month.
+
+
For capsule: Children (12-18 years):
+
+- Treatment of Vitamin D3 deficiency: 20000 IU once every 2 weeks for 6 weeks.
+- Prevention of Vitamin D3 deficiency: 20000 IU every 6 weeks.
+
+
For film-coated tablet: 1000 IU (1-2 tablets) daily, or as directed by physician. Take the medicine with food or within 1 hour after a meal.
For oroflash or chewable tablets: 1000 IU to 2000 IU daily, or as directed by physician. Take the medicine with food or within 1 hour after a meal. Place the tablet in mouth swallow after chewing.
For Syrup:
For patients with risk of Cholecalciferol deficiency:
+
+- 0-1 yr: 400 IU/ day (2 ml)
+- >1 Yr: 600 lU/ day (3 ml)
+
+For Cholecalciferol deficient patients:
+
+- 0-1 yr: 2000 IU/ day (+50000 IU/week ) for 6 weeks
+- 1 -18 yrs: 2000 IU/ day for 6 weeks.
+
+
Injection: Prevention:
+
+- Infants receiving Vitamin D enriched milk: 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. every 6 months.
+- Nursed infants or infants not receiving Vitamin D enriched milk or young children up to 5 years of age: 1 ampoule (1ml) i.e. 2,00000 I.U. every 6 months.
+- Adolescents: 1 ampoule (1ml) i.e. 2,00000 I.U. every 6 months during winter.
+- Pregnancy: 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. from the 6th or 7th month of pregnancy.
+- Elderly: 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. every 3 months. Digestive disorders, concomitant treatment with antiepileptics & other particular condition not described above; 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. or 1 ampoule (1ml) i.e. 2,00000 I.U. every 3 or 6 months.
+
+
Injection: Vitamin D deficiency:
+
+- 1 ampoule (1ml) i.e. 2,00000 I.U. which can be repeated 1 to 6 months later. Or, as directed by the registered physician.
+
",,"It interferes with phenytoin, barbiturates, glucocorticoids, certain laxative (such as liquid paraffin), actinomycin and imidazole antifungal agents.
","It is contraindicated in patients with known hypersensitivity to Vitamin D3.
","The general side effects are hypercalcaemia, hypercalciuria, skin rash, pruritus, urticaria, nausea, abdominal pain.
","Studies have shown safe use of doses up to 4000 IU during pregnancy. The recommended daily intake for pregnant women is 400 IU, however, in women who are considered to be Vitamin D3 deficient a higher dose may be required. During pregnancy women should follow the advice of their medical practitioner as their requirements may vary depending on the severity of their disease and their response to treatment
Vitamin D3 and its metabolites are excreted in breast milk. Overdose in infants induced by nursing mothers has not been observed; however, when prescribing additional vitamin D3 to a breast-fed child the practitioner should consider the dose of any additional vitamin D3 given to the mother.
","It should be used with caution in patients with impaired renal function.
","The safety & efficacy of Vitamin D3 in children under 12 years have not been established.
","It can lead to hypervitaminosis D.
",,,"Keep below 30º C temperature, protected from light & moisture. Keep out of the reach of children.
",12
+303,Colchicine,colchicine-303,https://medex.com.bd/attachments/fAKVqyEmbL8KPG8FsDWVmxnu3qpT84/colchicine-prescribing-information,Drugs used in Gout,Vasculitis,"Colchicine are indicated for treatment of acute gout flares. And also indicated in Familial Mediterranean fever (FMF) in adults and children 4 years or older.
","Drugs used in Gout
","An acute attack of gout apparently occurs as a result of an inflammatory reaction to crystals of monosodium urate that are deposited in the joint tissue from hyperuric body fluids; the reaction is aggravated as more urate crystals accumulate. Leukocytes migrate to the sites where urate crystals have been deposited and try to engulf the crystals by phagocytosis. As a result lactic acid and proinflammatory enzymes are released which cause inflammation with severe pain, redness, and swelling of the affected joint. Lactic acid favors a local decrease in pH that enhances uric acid deposition. Colchicine inhibits the phagocytosis of uric acid by leukocytes & also diminishes the lactic acid production directly. Thus interrupts the cycle of urate crystal deposition and inflammatory response that sustains the acute attack of gout.
Colchicine is absorbed when given orally, reaching a mean Cmax of 2.5 ng/mL (range 1.1 to 4.4 ng/mL) in 1 to 2 hours after a single dose administered under fasting conditions. The mean apparent volume of distribution is approximately 5 to 8 L/kg. Colchicine binding to serum protein is low (39 ± 5%), primarily to albumin regardless of concentration. CYP3A4 is involved in the metabolism of Colchicine to 2-O-demethylcolchicine and 3-O-demethylcolchicine. Plasma levels of these metabolites are minimal (less than 5% of parent drug). Following multiple oral doses (0.6 mg twice daily), the mean elimination half-life is 26.6 to 31.2 hours.
","Acute gouty arthritis:
+
+- First dose- 1 to 1.2 mg (two 0.5 mg or two 0.6 mg tablets) at a time every 2 hours until pain and inflammation aborted.
+- The total amount of colchicine needed to control pain and inflammation during an attack usually ranges from 4 to 8 mg.
+- Articular pain and swelling typically reduced within 12 hours and are usually gone in 24 to 48 hours, An interval of three days between colchicine courses is advised in order to minimize the possibility of cumulative toxicity.
+
+For prophylaxis during intercritical periods:
+
+- To reduce the frequency of their severity, colchicine may be administered continuously.
+- In patients who have less than one attack per year, the usual dose is 0.5 or 0.6 mg per day, three or four days a week.
+- For cases involving more than one attack per year, the usual dose is 0.5 or 0.6 mg daily.
+- Severe cases may require two or three 0.5 mg or 0.6 mg tablets daily.
+
+For prophylaxis against attacks of gout in patients undergoing surgery:
+
+- In patients with gout, an attack may be precipitated by even a minor surgical procedure. One 0.5 mg tablet or one 0.6 mg tablet three times daily should be administered for three days before and three days after surgery.
+
",,"Co-administration of P-gp and/or CYP3A4 inhibitors (e.g., clarithromycin or cyclosporine) have been demonstrated to alter the concentration of Colchicine
","Patients with renal or hepatic impairment should not be given Colchicine in conjunction with Permeability glycoprotein (P-gp) or strong CYP3A4 inhibitors (e.g., clarithromycin or cyclosporine).
","Blood dyscrasias: Myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, and aplastic anemia have been reported. Diarrhea and pharyngolaryngeal pain may occur.
","Pregnancy Category C. There are no adequate and well-controlled studies with Colchicine in pregnant women. Colchicine is excreted into human milk. Caution should be exercised when administered to a nursing woman.
",,"Pediatric Use: Gout is rare in pediatric patients. Safety and effectiveness of Colchicine in pediatric patients have not been established.
","The exact dose of colchicine that produces significant toxicity is unknown. Fatalities have occurred after ingestion of a dose as low as 7 mg over a 4-day period, while other patients have survived after ingesting more than 60 mg. A review of 150 patients who overdosed on colchicine found that those who ingested less than 0.5 mg/kg survived and tended to have milder toxicities, such as gastrointestinal symptoms, whereas those who took 0.5 to 0.8 mg/kg had more severe reactions, such as myelosuppression.
",,,"Store below 30°C temperature. Protect from light and moisture. Keep the medicine out of reach of children.
",11
+300,Cod Liver Oil,cod-liver-oil-300,,Specific combined vitamin preparations,Vitamin A deficiency,"
+- For the betterment of healthy body, bone, teeth, and muscles. It is widely taken to ease the pain and joint stiffness associated with arthritis
+- Promotes resistance towards cough, cold, chest and bronchial troubles. It has anti-thrombotic, anti-arrhythmic, anti-inflammatory, anti-hypertensive effects
... Read more
+- For the betterment of healthy body, bone, teeth, and muscles. It is widely taken to ease the pain and joint stiffness associated with arthritis
+- Promotes resistance towards cough, cold, chest and bronchial troubles. It has anti-thrombotic, anti-arrhythmic, anti-inflammatory, anti-hypertensive effects
+- Decreases the triglycerides and increases HDL level
+- Facilitates the normal growth, development and function of the central nervous system of fetus and infant
+- Helps to prevent vitamin A & Vitamin D deficiency
+- Pregnant women using Cod Liver Oil have infants with a lower risk for juvenile type 1 diabetes
+
","Specific combined vitamin preparations
","Cod Liver Oil is one of the most effective providers of Omega-3 Fatty Acids, and an excellent source of Vitamin A and Vitamin D. It contains Eicosapentaenoic Acid (EPA: 18%) & Docosahexaenoic Acid (DHA: 12%) which are been clinically proven to have positive effects on heart, bone, brain, health. They also help to nourish skin, hair, and nails.
","Capsule-
+
+- Adults and children over 6 years: Take 1-2 capsule(s) 3 times a day with meals, or as professionally prescribed.
+- Children under 6 years: Only as professionally prescribed.
+- Pregnant and lactating women: Take 1 capsule 3 times a day with meals.
+
+Emulsion-
+
+- Infant: ½ tsf daily.
+- Child (1-4 year): 1 tsf daily
+- Child over 4 years: 1.5 tsf daily
+
",,"The absorption of Cod Liver Oil may be reduced by taking barbiturates or anti-convulsants.
","Hypervitaminosis of Vitamin A, D or E and hypersensitivity to any of the ingredients in this preparation.
","Prolonged usage of large amounts can lead to hypervitaminosis symptoms of which include dry mouth, rough skin, painful joints swelling, fatigue, anorexia, loss of weight, vomiting and other gastrointestinal disturbances. These may disappear on discontinuation of supplementation.
","Safety of amounts exceeding 6,000 Units of Vitamin A daily during pregnancy has not been established yet. The recommended daily allowance (RDA) of vitamin A is 5,000
Units for nursing mothers.
","The product has to be protected from light. Liver storage should be adequate before discontinuation of the therapy. Patients with chronic renal failure should be suggested Cod Liver Oil with caution.
",,"When taken in large amounts, Cod Liver Oil can lead to complications including increased risk for hemorrhagic stroke and internal bleeding.
",,,"Store in a cool and dry place protected from light and moisture.
",11
+902,Coal Tar Solution,coal-tar-solution-902,,Coal-tar preparations,Seborrhea,"Polytar Scalp Shampoo effectively controls dandruff, stubborn dandruff and scalp psoriasis. Polytar has a unique formulation containing: natural tars to clear scales, relieve itching and inflammation, and slow the rate of skin cell growth oils to moisturise the scalp.
","Coal-tar preparations, Emollients & combined preparations
","Polytar Scalp Shampoo is a thick, coal-tar based shampoo that soothes irritated skin on the scalp, reducing itchiness, scaling, and inflammation.
These symptoms are often experienced by people with scalp psoriasis or other related skin conditions such as eczema. In these cases, a specially formulated shampoo is required, as standard shampoos often contain irritants that make the condition worse.
Coal tar is proven to provide relief for psoriasis sufferers. It is a thick oil that works on patches of inflamed red skin covered in scales. It moisturises and nourishes the skin to reduce scales and dandruff, and soothes it to make it feel less itchy.
This shampoo can be used by adults and children aged 12 or over.
","Polytar Scalp Shampoo should be used by adults and children over the age of 12, once or twice per week for an initial period of 4 weeks.
First, wet your hair and then massage a small amount of the shampoo into the scalp and any affected areas nearby, using the fingertips. After it has lathered, rinse the scalp well. Repeat this process, ensuring that the shampoo is in contact with scalp for around 3-5 minutes in total over the two applications.
For use for longer than a period of 4 weeks, consult a doctor and use as directed.
",,,"Hypersensitivity
","In rare cases, Polytar Scalp Shampoo is associated with skin reactions due to allergies (rashes, swelling, difficulty breathing). Other possible rare side effects include eye irritation, hair loss, itchy and redskin, change of hair colour or texture, and burning sensations on the skin.
If you are taking other medications, speak to your doctor before using this shampoo, as certain antibiotics and tranquilizers increase sensitivity to sunlight.
","Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","Keep Polytar Scalp Shampoo away from children, in a cool place. Use eternally only and take care not to get any in the eyes.
Avoid using this product if you are allergic to coal tar or any of the listed ingredients. It is not suitable for use by children below the age of 12, and never use on open, damaged, or blistered skin.
In some cases, especially where excessive shampoo is used or it is used more frequently than advised, irritation may occur. This may also occur if the shampoo is in contact with sensitive or inflamed skin. If you experience such a reaction, stop using it.
While using this shampoo, avoid strong sunlight and sunbeds, as some people become extra-sensitive to UV radiation. It’s best to wear protective clothing and sunscreen until you know how you will react. Also, if you are taking other medicines that make you more sensitive to sunlight, seek your doctor’s advice before using this shampoo.
If you are pregnant, avoid using it in the first trimester of pregnancy; consult with your doctor before using while breastfeeding.
",,,,,,8
+299,Coal Tar + Precipitated Sulphur + Salicylic Acid,coal-tar-precipitated-sulphur-salicylic-acid-299,https://medex.com.bd/attachments/zJHUYPEw8qc1oICfoMG62zd6bdgMqq/coal-tar-precipitated-sulphur-salicylic-acid-prescribing-information,Coal-tar preparations,Seborrhoeic dermatitis,"This Scalp Ointment has mild, antipruritic, antiseptic and keratolytic properties. It is indicated in the treatment of common scaly skin disorders of the scalp such as psoriasis, eczema, seborrhoeic dermatitis and dandruff.
","Coal-tar preparations
","Coal Tar has antipruritic, keratoplastic and keratolytic properties. It slows down excessive epidermal cell turnover and is often used topically either alone or in combination with other drugs (e.g. salicyclic acid, sulfur) in conditions such as dandruff, seborrheic dermatitis or psoriasis.
Precipitated Sulpher is converted to hydrogen sulfide (H2S) through reduction, partly by bacteria. H2S kills bacteria (possibly including Propionibacterium acnes which plays a role in acne) fungi, and parasites such as scabies mites.
Salicylic Acid has a potent keratolytic action and a slight antiseptic action when applied topically. It softens and destroys the stratum corneum by increasing endogenous hydration which causes the horny layer of the skin to swell, soften, and then desquamate. At high concentrations, salicylic acid has a caustic effect. It also possesses weak antifungal and antibacterial activity.
","Adults, children over 12 years and the elderly: Apply to the affected areas of the scalp and remove after one hour using warm water and shampoo. Repeat the process daily for three to seven days until control has been obtained. With mild scaliness use intermittently as necessary.
Children 6-12 years: To be used under medical supervision only.
Children under 6 years: Not recommended.
","Coal Tar ointment is for external use only, ie applied onto the skin. Follow your doctor’s instructions and check the leaflet on how to use. In severe scaly scalp conditions it is usually necessary to apply Coal Tar ointment daily for 3-7 days until control has been obtained. With mild scaliness use intermittently as necessary, eg once a week.
+
+- Pierce the tube membrane by inverting the cap. This scalp applicator to the threaded portion of the tube.
+- Part the hair and apply a thin ribbon of Coal Tar ointment to the affected areas of the scalp. Take care to avoid contact with the eyes. Gently rub in the ointment and leave in contact with scalp for approximately one hour. Wash the hands immediately afterwards.
+- After One hour remove the ointment by showering or rinsing with warm water. If after the first week there is no improvement or after 4 weeks symptoms persist, consult your doctor. If you accidentally get some into your eyes wash it out immediately with plenty of cold tap water. If irritation of the eyes develops consult your doctor or pharmacist.
+
",,"Cool tar Scalp Ointment is contraindicated in patients known to be sensitive to sulfur, salicylates, coal tar or in the presence of local infections. Warnings & Precautions: Do not use if the tube membrane is already perforated. Avoid contact with the eyes and wash your hands. Discontinue use if irritation develops. If symptoms persist after four weeks, consult your doctor.
","Coal Ta ointment may occasionally cause irritation of the skin, inflammation of the hair follicles and rarely photosensitivity of the skin.
","To be used at the discretion of the physician.
",,,"Overdose is extremely unlikely If necessary, remove medication by washing with warm water and treat symptomatically.
",,,"Store in a cool and dry place, protected from light.
",10
+298,Coal Tar,coal-tar-298,https://medex.com.bd/attachments/WM7OSlacIHdznQH7z4UuWkC3pop7fQ/coal-tar-prescribing-information,Coal-tar preparations,Seborrhoeic dermatitis,"Coal Tar Cream is indicated for psoriasis. Soritar Cream has a keratoplastic and antipruritic effect in psoriasis.
","Coal-tar preparations
","Coal tar has antipruritic, keratoplastic and keratolytic properties. It slows down excessive epidermal cell turnover and is often used topically either alone or in combination with other drugs (e.g. salicyclic acid, sulfur) in conditions such as dandruff, seborrheic dermatitis or psoriasis.
","Adults and children over 12 years of age: Ensure that the lesions are clean. Apply a thin layer of Coal Tar Cream two or three times a day on to the affected areas massage in gently and leave to dry.
For young children under 12 years of age and the elderly: The emulsion may be diluted by mixing it with a few drops of cooled freshly boiled in the palm of the hand.
","For topical application only.
",,"Coal Tar should not be used when a patient has known sensitivity to Coal Tar or any of the other ingredients. If you have folliculitis and acne vulgaris. Coal Tar Cream should not be used on patients who have disease characterised by photosensitivity such as lupus erythematosus or allergy to sunlight. Coal Tar Cream should not be applied to inflamed or broken skin. Warnings and precautions: For topical administration only. Coal Tar Cream may cause skin irritation, should this occur the treatment should be reviewed and if necessary discontinued. Coal Tar enhances photosensitivity of the skin after applying Coal Tar Cream exposure to direct sunlight should be avoided. Use with care near the eyes and mucous membranes. If any emulsion should accidentally enter the eye, flush with normal saline solution or water. Do not apply to genital and rectal areas. Apply with caution to the face do not get in the eyes. Hydrogenated polyoxyl castor oil may cause skin reactions. Methyl and propyl hydroxybenzoates may cause allergic reactions that might be cause a delayed reaction.
","Skin and subcutaneous tissue disorders: Skin irritation, photosensitivity of the skin, Coal Tar Cream may cause acne-like eruptions of the skin. There is an increased risk of skin cancer in psoriatic patients treated with a combination of Coal Tar Cream and UVB radiation has been reported. However epidemiological studies of patients treated with Coal Tar Cream on its own are inconclusive. The risk of toxicity should be taken into account when considering the prescribing this product for the patient.
","There is no direct evidence of the safety in pregnant and lactating mother. Coal tar preparations have been in use for many years without apparent ill-consequence. No harmful effects on the health of the child is anticipated with the proper use of coal tar. However it is recommended that the use of coal tar in pregnancy and lactation is restricted to intermittent use in low concentrations on a small percentage of body’s surface, use during the first trimester be avoided.
",,,"There is no evidence that an overdose of topical Coal Tar Cream would be harmful other than a hypersensitivity to coal tar. Ingestion of Coal Tar Cream may require gastric lavage depending on the quantity taken and should be treated symptomatically.
",,,"Store in a cool and dry place, protected from light.
",10
+1244,Coagulation Factor VIIa [Eptacog Alfa],coagulation-factor-viia-eptacog-alfa-1244,https://medex.com.bd/attachments/ESx6IKqn4FFZyzLXDTsSNCVF3jaVUw/coagulation-factor-viia-eptacog-alfa-prescribing-information,Anti-fibrinolytic drugs,Hemophilia,"Coagulation Factor VIIa is indicated in Bleeding episodes in patients with haemophilia, Bleeding episodes due to surgery or invasive procedures in patients with factor VII deficiency, Bleeding episodes due to surgery or invasive procedures in Glanzmann's thrombasthenia
","Anti-fibrinolytic drugs
","Recombinant factor VIIa is a biosynthetic preparation of activated factor VII produced by recombinant DNA technology. It is a vitamin K-dependent glycoprotein. It promotes haemostasis by activating the extrinsic pathway of the coagulation cascade. It replaces deficient activated coagulation factor VII, which complexes with tissue factor and may activate coagulation factor X and factor IX. Factor VIIa is given as the recombinant form, eptacog alfa (activated).
","Bleeding episodes in patients with haemophilia:
+
+- Adult: As activated eptacog alfa: Initially, 90 mcg/kg given via IV bolus over 2-5 min. Additional dose may be given as needed to achieve or maintain haemostasis, initially 2-3 hrly. May adjust dose or dosing interval according to response. May continue therapy for up to 3 wk or more in cases of serious bleeding episodes.
+
+Bleeding episodes due to surgery or invasive procedures in patients with factor VII deficiency:
+
+- Adult: As activated eptacog alfa: 15-30 mcg/kg 4-6 hrly via IV bolus over 2-5 min until haemostasis is achieved.
+
+Bleeding episodes due to surgery or invasive procedures in Glanzmann's thrombasthenia:
+
+- Adult: As activated eptacog alfa: 90 mcg/kg 2 hrly via IV bolus over 2-5 min, give at least 3 doses.
+
",,"Increased risk of thromboembolism with activated or non-activated prothrombin complex concentrate.
","Hypersensitivity to recombinant coagulation factor VIIa or to mouse, hamster or bovine protein. Rare hereditary problems of fructose intolerance, glucose malabsorption or sucrose-isomaltase insufficiency.
","Nausea, vomiting, skin reactions, fever, headache and changes in BP. Rarely, anaphylaxis.
","It is preferable to avoid use during pregnancy. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
It is unknown whether eptacog alfa is excreted in human breast milk. The excretion of eptacog alfa in milk has
not been studied in animals.
","Advanced atherosclerotic disease, crush injury, septicemia or disseminated intravascular coagulation. Patients w/ history of CHD, liver disease, undergoing major surgery, at risk of thromboembolic phenomena or disseminated intravascular coagulation. Remote possibility of hypersensitivity to mouse IgG, bovine IgG & other residual culture proteins. Monitor prothrombin time & factor VII coagulant activity in factor VII deficient patients. Pregnancy & lactation. Neonates.
",,,,"Add the recommended diluent (histidine), swirl gently until dissolved.
","Store between 2-25° C prior to reconstitution. Do not freeze. Protect from light.
",11
+297,Clozapine,clozapine-297,https://medex.com.bd/attachments/jCnEa7Od86DMesUtU8Ahg2KG4Wp8iC/clozapine-prescribing-information,Atypical neuroleptic drugs,Severe anxiety disorders,"Clozapine is indicated in-
+
+- Schizophrenia in patients unresponsive to, or intolerant of, conventional antipsychotic drugs.
+- Psychosis in Parkinson's disease.
+
","Atypical neuroleptic drugs
","Clozapine is classified as an 'atypical' antipsychotic drug because of its profile of binding to dopamine receptors and its effects on various dopamine-mediated behaviors differ from those exhibited by other typical antipsychotic drug products. In particular, although Clozapine does interfere with the binding of dopamine at D1, D2, D3 and D5 receptors, and has a high affinity for the D4 receptor. This evidence, consistent with the view that Clozapine is preferentially more active at limbic than at striatal dopamine receptors. This may explain the relative freedom of Clozapine from extrapyramidal side effects. Clozapine also acts as an antagonist at adrenergic, cholinergic, histaminergic and serotonergic receptors.
","Schizophrenia: Adult over 16 years, 12.5 mg once or twice (elderly 12.5 mg once) on first day then 25-50 mg (elderly 25-37.5 mg) on second day then increased gradually (if well tolerated) in steps of 25-50 mg daily (elderly max. increment 25 mg daily) over 14-21 days up to 300 mg daily in divided doses (larger dose at night, up to 200 mg daily may be taken as a single dose at bedtime); if necessary may be further increased in steps of 50-100 mg once (preferably) or twice weekly; usual dose 200-450 mg daily (max. 900 mg daily)
Psychosis in Parkinson's disease: Adult over 16 years, 12.5 mg at bedtime then increased according to response in steps of 12.5 mg up to twice weekly; usual dose range 25-37.5 mg at bedtime, usual maximum 50 mg daily; exceptionally, dose may be increased further in steps of 12.5 mg weekly to maximum 100 mg daily in 1-2 divided doses.
",,"Myelosuppression may be aggravated with concomitant use of myelosuppressants. Clozapine may interact with other CNS active drugs or alcohol. Orthostatic hypotension may occur with benzodiazepine usage or other psychotropics. Since Clozapine is highly bound to proteins. It may be displaced by other drugs, which are also highly protein bound. Conversely, Clozapine may also displace protein bound drugs (e.g. warfarin, digoxin). Cimetidine may decrease plasma Clozapine levels.
Although concomitant administration of Carbamazepine and Clozapine is not recommended, it should be noted that discontinuation of concomitant Carbamazepine may result in an increase in plasma Clozapine levels. A reduced Clozapine dosage should be used when it is combined with drugs like fluvoxamine, paroxetine and sertraline. The action of hypotensive drugs may be potentiated. Other anticholinergic drug action may also be increased. Administration of adrenaline should generally be avoided due to possibility of reversal of adrenaline effect due to alpha adrenergic blockade by Clozapine. Concomitant use of Clozapine with other drugs metabolized by cytochrome P450 2D6 (such as phenothiazines, antidepressants, propafenone, flecainide and encainide) or those that inhibit this enzyme such as quinidine; require lower doses of either Clozapine or the other drugs.
","Severe cardiac disorders (e.g. myocarditis); renal impairment (avoid if creatinine clearance less than 10 ml/minute); history of neutropenia or agranulocytosis; bone-marrow disorders; paralytic ileus; alcoholic and toxic psychoses; history of circulatory collapse; drug intoxication; coma or severe CNS depression; uncontrolled epilepsy; breast-feeding.
","Common side effects are constipation, dizziness or lightheadedness (mild), drowsiness, headache (mild), increased watering of mouth, nausea or vomiting, unusual weight gain. Less common side effects include abdominal discomfort or heartburn, dryness of mouth.
","There are no adequate studies of Clozapine in pregnant women. Studies in animals suggest no important effects on the fetus. Clozapine can be used in pregnancy if the physician feels that it is necessary. Animal studies suggest that Clozapine is secreted in breast milk. Therefore, women taking Clozapine should not nurse their infants.
","Medication should not be stopped abruptly; should be tapered off over 1-2 weeks. If conditions warrant abrupt discontinuation (leukopenia, myocarditis, cardiomyopathy), monitor patient for psychosis and cholinergic rebound (headache, nausea, vomiting, diarrhea). Elderly patients are more susceptible to adverse effects (including agranulocytosis, cardiovascular, anticholinergic, and tardive dyskinesia). Significant risk of agranulocytosis, potentially life-threatening. WBC testing should occur weekly for the first 6 months of therapy; thereafter, if acceptable WBC counts are maintained (WBC 3000/mm3, ANC 1500/mm3) then WBC counts can be monitored every other week. WBCs must be monitored weekly for the first 4 weeks after therapy discontinuation. Use with caution in patients receiving other marrow suppressive agents. Eosinophilia has been reported to occur with Clozapine and may require temporary or permanent interruption of therapy.
Cognitive and/or motor impairment (sedation) is common with Clozapine, resulting in impaired performance of tasks requiring alertness (eg, operating machinery or driving). Use with caution in patients at risk of seizures, including those with a history of seizures, head trauma, brain damage, alcoholism, or concurrent therapy with medications which may lower seizure threshold. Has been associated with benign, self-limiting fever (<100.4°F, usually within first 3 weeks). However, dozapine may also be associated with severe febrile reactions, including neuroleptic malignant syndrome (NMS). Clozapine's potential for extrapyramidal symptoms appear to be extremely low.
May cause anticholinergic effects; should be used with caution in patients with urinary retention, benign prostatic hyperplasia, narrow-angle glaucoma, xerostomia, visual problems, constipation, or history of bowel obstruction. May cause hyperglycemia; in some cases may be extreme and associated with ketoacidosis, hyperosmolar coma, or death. Use with caution in patients with diabetes or other disorders of glucose regulation; monitor for worsening of glucose control. Use with caution in patients with hepatic disease or impairment; hepatitis has been reported as a consequence of therapy.
May cause orthostatic hypotension and tachycardia; should be used with caution in patients at risk of hypotension or in patients where transient hypotensive episodes would be poorly tolerated (cardiovascular disease or cerebrovascular disease). Concurrent use of psychotropics and benzodiazepines may increase the risk of severe cardiopulmonary reactions.
Myocarditis, pericarditis, pericardial effusion, cardiomyopathy, and CHF have also been associated with clozapine. Fatalities due to myocarditis have been reported; highest risk in the first month of therapy, however, later cases also reported. Myocarditis or cardiomyopathy should be considered in patients who present with signs/symptoms of heart failure (dyspnea, fatigue, orthopnea, paroxysmal nocturnal dyspnea, peripheral edema), chest pain, palpitations, new electrocardiographic abnormalities (arrhythmias, ST-T wave abnormalities), or unexplained fever. Patients with tachycardia during the first month of therapy should be closely monitored for other signs of myocarditis. Discontinue clozapine if myocarditis is suspected; do not rechallenge in patients with clozapine-related myocarditis. The reported rate of cardiomyopathy in clozapine treated patients is similar to that in the general population. The majority of patients were over 50 years of age and were taking clozapine for >6 months. Clozapine should be discontinued in patients with confirmed cardiomyopathy unless benefit clearly outweighs risk. Rare cases of thromboembolism, including pulmonary embolism and stroke resulting in fatalities, have been associated with clozapine.
",,"The most commonly reported signs and symptoms associated with Clozapine overdose are: altered states of consciousness, including drowsiness, delirium and coma; tachycardia; hypotension; respiratory depression or failure; hypersalivation. Aspiration pneumonia and cardiac arrhythmias have also been reported. Seizures have occurred in a minority of reported cases. Fatal overdoses have been reported with Clozapine, generally at doses above 2500 mg. There have also been reports of patients recovering from overdoses well in excess of 4 gm.
Management of Overdose: Should be established and maintained an airway; should be ensured adequate oxygenation and ventilation. Activated charcoal, which may be used with sorbitol, may be as or more effective than emesis or lavage, and should be considered in treating overdosage. Cardiac and vital signs monitoring is recommended along with general symptomatic and supportive measures. Additional surveillance should be continued for several days because of the risk of delayed effects. Avoid epinephrine and derivatives when treating hypotension, and quinidine and procainamide when treating cardiac arrhythmia. There are no specific antidotes for Clozapine. Forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit. ln managing overdosage, the physician should consider the possibility of multiple drug involvement.
",,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",11
+292,Cloxacillin Sodium,cloxacillin-sodium-292,https://medex.com.bd/attachments/cB8FmURFg7ayHlmcVgu5wfDqWvlKea/cloxacillin-sodium-capsules-oral-solution-prescribing-information,Penicillinase-resistant penicillins,UTI caused by Staphylococcus Aureus,"গ্রাম-পজিটিভ জীবাণু দ্বারা সৃষ্ট সংক্রমণের চিকিৎসায় ক্লক্সাসিলিন নির্দেশিত। পেনিসিলিনেজ উৎপাদনক্ষম স্টেফাইলোকক্কাই জনিত সংক্রমণের চিকিৎসায়ও এটি নির্দেশিত। এ জাতীয় সংক্রমণের মধ্যে রয়েছেঃ
স্কিন ও সফ্ট টিস্যু সংক্রমণ: ফোঁড়া (boils), পূজাশয় (abscess), কার্বাংকল, ফারানকুলোসিস, সেলুলাইটিস, সংক্রমিত ক্ষত (infected wounds), সংক্রমিত পোড়া (infected burns), ত্বক প্রতিস্থাপন প্রতিরক্ষা (protection for skin grafts), ত্বকের বিভিন্ন সংক্রমণ যেমন আলসার, একজিমা ও একনি।
রেসপিরেটরী ট্র্যাক্ট, নাক, কান ও গলার সংক্রমণ: নিউমোনিয়া, ফুসফুসের পূজাশয় (lung abscess), এমপায়েমা, সাইনোসাইটিস, ফ্যারিনজাইটিস, টনসিলাইটিস, কুইনসি, অটাইটিস মিডিয়া ও এক্সটারণা।
ক্লক্সাসিলিন-সংবেদনশীল (sensitive), জীবাণু জনিত অন্যান্য সংক্রমণ: অসটিওমায়েলাইটিস, এনটেরাইটিস, এনডোকারডাইটিস, ইউরিনারী ট্র্যাক্ট সংক্রমণ ও সেপটিসেমিয়া।
","Penicillinase-resistant penicillins
",,"প্রাপ্তবয়স্কদের প্রচলিত মাত্রা-
খাওয়ার জন্য: ৫০০ মিগ্রা দিনে চার বার আহারের আধা থেকে এক ঘন্টা আগে।
ইনজেকশন হিসেবে:
+
+- মাংসপেশীতে ইনজেকশন হিসেবে: ২৫০ মিগ্রা চার থেকে ছয় ঘন্টা পর পর।
+- শিরাপথে ইনজেকশন হিসেবে: ৫০০ মিগ্রা চার থেকে ছয় ঘন্টা পর পর। প্রয়োজনবোধে উপরোল্লিখিত মাত্রাকে দ্বিগুণ করা যেতে পারে।
+- প্লুরাল কেভিটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা দিনে এক বার।
+- জয়েন্ট কেভিটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা দিনে এক বার।
+
+
শিশুদের প্রচলিত মাত্রা-
খাওয়ার জন্য: ২ থেকে ১০ বৎসর পর্যন্ত- প্রাপ্তবয়স্ক মাত্রার অর্ধেক। ২ বৎসরের নীচে- প্রাপ্তবয়স্ক মাত্রার এক-চতুর্থাংশ।
ইনজেকশন হিসেবে:
+
+- মাংসপেশীতে ইনজেকশন হিসেবে: ২৫০ মিগ্রা এর সাথে ১.৫ মিলি কিংবা ৫০০ মিগ্রা এর সাথে ২ মিলি ওয়াটার ফর ইনজেকশন বিপি মিশিয়ে দ্রবীভূত করতে হবে।
+- শিরাপথে ইনজকেশন হিসাবে: ৫০০ মিগ্রা এর সাথে ৫-১০ মিলি ওয়াটার ফর ইনজকেশন বিপি মিশিয়ে দ্রবীভূত করতে হবে। এরপর এই দ্রবণকে তিন থেকে চার মিনিট ধরে ধীরে ধীরে শরীরে প্রয়োগ করতে হবে। ক্লক্সাসিলিন ইনজকেশনকে ইনফিউশন উপযোগী যে কোন তরলে মিশিয়ে দেয়া যায় অথবা যথাযথ ভাবে হালকা করে ড্রপি টউিবে তিন থেকে চার মিনিট ধরে ধীরে ধীরে প্রয়োগ করা যায়।
+- প্লুরাল কেভেটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা এর সাথে ৫ থেকে ১০ মিলি ওয়াটার ফর ইনজকেশন বিপি মিশিয়ে দ্রবীভূত করে প্রয়োগ করতে হবে।
+- জয়েন্টে কেভেটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা এর সাথে অনধকি ৫ মিলি ওয়াটার ফর ইনজকেশন বিপি অথবা ০.৫% লিগনোকেইন হাইড্রোক্লোরাইড দ্রবণ মিশিয়ে দ্রবীভূত করে প্রয়োগ করতে হবে।
+
",,,"পেনিসিলিনে অতি-সংবেদনশীল (hypersensitive) রোগীদের ক্ষেত্রে ক্লক্সাসিলিন প্রয়োগ নিষিদ্ধ।
","ক্���ক্সাসিলিন এর পার্শ্ব-প্রতিক্রিয়া অন্যান্য পেনিসিলিনের মতই। এগুলো সাধারণতঃ মৃদু ও ক্ষণস্থায়ী হয়ে থাকে। এই সমস্ত পার্শ্ব-প্রতিক্রিয়ার মধ্যে রয়েছে জ্বর, ডায়রিয়া, অজীর্ণ (indigestion), র্যাশ-আরটিকারিয়েল অথবা ইরিথিমেটাস জাতীয়। যে কোন ধরণের র্যাশে রোগীকে এ ওষুধ দেয়া বন্ধ করতে হবে।
",,"যে সব রোগীর এলার্জির পূর্ব ইতিহাস আছে তাদের বেলায় ক্লক্সাসিলিন সতর্কতার সাথে ব্যবহার করতে হবে। ক্লক্সাসিলিন সাব-কনজাংটিভাল ইনজেকশন হিসেবে অথবা চোখের ড্রপস হিসেবে দেয়া যাবে না।
ক্লক্সাসিলিন সিরাপ ও ড্রপস ব্যবহরের আগে তাৎক্ষনিকভাবে তৈরী করে ঠাণ্ডা স্থানে (সম্ভব হলে রেফ্রিজারেটরে) রাখতে হবে। সংমিশ্রিত সিরাপ ও ড্রপস সাধারণ তাপমাত্রায় রাখলে পাঁচ দিনের মধ্যে অথবা রেফ্রিজারেটরে রাখলে সাত দিনের মধ্যে ব্যবহার করতে হবে। মাংসপেশীতে বা শিরাপথে প্রয়োগের জন্য প্রস্তুতকৃত ক্লক্সাসিলিন দ্রবণ তৈরীর ৩০ মিনিটের মধ্যে ব্যবহার করতে হবে। অবশ্য ক্লক্সাসিলিন এর জলীয় দ্রবণ স্বাভাবিক তাপমাত্রায় (২৫° সেঃ) অনধিক ২৪ ঘন্টা পর্যন্ত কার্যকর থাকে।
শিরাপথের প্রয়োগোপযোগী অধিকাংশ তরলের সাথেই ক্লক্সাসিলিন মেশানো যায়। তবে কখনোই আমিষ জাতীয় তরল (যেমন প্রোটিন হাইড্রোলাইসেটস) এর সাথে মেশানো যাবে না।
",,,,,"ক্লক্সাসিলিন এর সকল ডোসেজ ফরমকে ঠান্ডা ও শুকনো স্থানে রাখতে হবে। ক্লক্সাসিলিন ইনজেকশন ভায়ালকে অনধিক ২৫° সেঃ তাপমাত্রায় সংরক্ষণ করুন।
",7
+1607,Clove oil,clove-oil-1607,,Oral preparations,Pharyngitis,"Clove oil is indicated in Bad breath (Halitosis), Tooth decay, Oral thrush, Dental pain, Inflammation of the mouth and pharynx.
","Oral preparations
","Clove oil is a herbal medicine which main ingredient is clove oil. It contains a large amount of eugenol that is commonly used in the treatment of oral infections and inflammation of the mucous membranes of the mouth and throat. Clove oil is effective, safe and well tolerated for all age groups
","Adult: Should be taken 5 ml Clove oil with 10 ml-15 ml water and gurgle for 30 seconds of morning & bedtime daily.
Children: Should be taken 2.5 ml Clove oil with 10 ml water and gurgle for 30 seconds of morning & bedtime daily. Also undiluted clove oil is used in temporary relief of toothache due to dental cavity. Repeat administration after 20 minutes, then every 2 hours thereafter if necessary.
",,,,"In concentrated form oil of clove may be irritating to mucosal tissues.
","There are no known problems with the use of Clove oil during pregnancy and lactation.
",,,,,,"Store below 30°C. temperature & dry place, protected from light. Keep all medicines out of reach of children.
",7
+290,Clotrimazole + Hydrocortisone,clotrimazole-hydrocortisone-290,https://medex.com.bd/attachments/4wBxizrqwS90AZdSUdmi9aEYI1Dcb4/clotrimazole-hydrocortisone-prescribing-information,Hydrocortisone & Combined preparations,Dermatophytosis,"The treatment of fungal infections where co-existing symptoms of inflammation e.g. itching, require rapid relief.
+
+- All dermatomycoses due to dermatophytes (e.g. Trichophyton species), moulds and other fungi.
+- All dermatomycoses due to yeasts (Candida species).
+- Skin diseases showing secondary infection with these fungi
+- The treatment of nappy rash where infection due to Candida albicans is present.
+
","Hydrocortisone & Combined preparations
","Clotrimazole is a broad-spectrum antifungal agent active on dermatophytes, yeasts and other fungi. Hydrocortisone is a glucocorticoid with both glucocorticoid and to a lesser extent mineralocorticoid activity. Hydrocortisone is used for replacement therapy in adrenocortical insufficiency.
","Apply thinly and evenly to the affected area twice daily.
",,,"It is contraindicated in patients with known hypersensitivity to any of the components of this preparation.
","Rarely local mild burning or irritation may be experienced. Hypersensitivity reactions may occur.
",,"In infants, the napkins may act as an occlusive dressing and increase absorption. Treatment should be for a maximum period of seven days.
",,,,,"Keep in a cool and dry place. Keep out of the reach of children.
",8
+291,Clotrimazole (Vaginal tablet),clotrimazole-vaginal-tablet-291,https://medex.com.bd/attachments/iFLPGmUe8SMBBsvfPAx7CBqoIqdjDq/clotrimazole-vaginal-tablet-prescribing-information,Topical Antifungal preparations,Vulvovaginal candidiasis,"Clotrimazole rectal preparation is indicated in vaginal itching, burning and discharge associated with recurrent vaginal yeast infections (Vaginal candidiasis) and also in viginitis due to Candida species as well as Mycotic infections complicated by other microorganisms sensitive to the drug.
","Drugs used in Vaginal and Vulval condition, Topical Antifungal preparations
","Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of pathogenic dermatophytes, yeasts, moulds and bacteroids. Clotrimazole is also active against certain gram-positive bacteria especially Staphylococci and Tricomonas. Like other imidazoles, Clotrimazole alters the permeability of fungal cell walls by interfering with cell wall lipids. At fungi static levels the main effect is inhibition of ergosterol synthesis but at higher concentrations there is an additional mechanism of membrane damage unrelated to sterol synthesis.
","Clotrimazole 100 mg & 200 mg vaginal preparation-
+
+- First infections: In general, a 3-day treatment is sufficient for Candida vaginitis. On 3 consecutive nights, Clotrimazole 200 mg vaginal preparation is inserted as deeply as possible into the vagina. This is best achieved when lying on one's back with the knees slightly bent.
+- Re-infections: In general, a 6-day treatment is sufficient. This applies also to mixed infections with the above-mentioned causative organisms. On six consecutive nights, 1 Clotrimazole 100 mg vaginal preparation is inserted as deeply as possible into the vagina. If necessary, 2 Clotrimazole 100 mg (1 in the morning and 1 in the evening) or 1 Clotrimazole 200 mg daily can be used for 6-12 days. Treatment should be timed so as to avoid the menstrual period and be finished before the onset of menstruation. To avoid re-infection, the partner should undergo local treatment with Clotrimazole cream at the same time.
+
+
Clotrimazole 500 mg vaginal preparation: Single dose, complete treatment with one vaginal tablet. The tablet should be inserted as deeply as possible into the vagina. This is best achieved when lying on one's back with the knees slightly bent. It is recommended that the treatment should be timed so as to avoid the menstrual period. For prevention of re-infection the partner should be treated locally with Clotrimazole cream at the same time.
Clotrimazole vaginal preparation are colorless and do not stain the underwear.
","
+- Pull out plunger until it stops. Place a vaginal tablet into the applicator
+- Insert applicator containing the tablet carefully as deeply as possible into the vagina (best lying on your back)
+- Push plunger until it stops, there by depositing the tablet into the vagina. Remove the applicator
+- After use, remove plunger completely by pulling it out of the applicator
+- Then wash it in warm (not boiling) soapy water, rinse and dry carefully
+
+Note: Pregnant women must follow physician's instructions
","No information is available.
","It is contraindicated in patients with known hypersensitivity to any of the components of this product.
","Since there is practically no Clotrimazole absorption through the vaginal skin, no systemic effect is expected. The local tolerance of Clotrimazole vaginal tablet is generally good. Local irritation or burning sensation may occur in a very few cases but these symptoms are not considered harmful.
","It is recommended that Clotrimazole should be used in pregnancy only when considered necessary by the physician. Clotrimazole is very poorly absorbed into the blood and the body after application to the skin or the vagina. Studies in women in their second or third trimesters have demonstrated no ill effects. It is not known if Clotrimazole is secreted in breast milk. Clotrimazole suppository can be used during pregnancy, but only under the supervision of Physician.
",,,,,,"Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+1785,Clotrimazole (Vaginal suppository),clotrimazole-vaginal-suppository-1785,,Topical Antifungal preparations,Vaginitis,"Clotrimazole vaginal suppository is used in candidal vaginitis.
","Drugs used in Vaginal and Vulval condition, Topical Antifungal preparations
","Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of pathogenic dermatophytes, yeasts, moulds and bacteroids. Clotrimazole is also active against certain gram-positive bacteria especially Staphylococci and Tricomonas. Like other imidazoles, Clotrimazole alters the permeability of fungal cell walls by interfering with cell wall lipids. At fungi static levels the main effect is inhibition of ergosterol synthesis but at higher concentrations there is an additional mechanism of membrane damage unrelated to sterol synthesis.
","One suppository should be inserted intravaginally daily (preferably at night) for three consecutive days. The suppository should be inserted into the vagina, as high as possible. This is best achieved when lying back with legs bent up. Or as directed by the physicians.
",,,"Clotrimazole is contraindicated for patients who are hypersensitive to Clotrimazole.
","Occasional skin irritation or burning sensation may occur in a very few cases which are not considered harmful.
","Clotrimazole is very poorly absorbed into the blood and the body after application to the skin or the vagina. Studies in women in their second or third trimesters have demonstrated no ill effects. It is not known if Clotrimazole is secreted in breast milk. Clotrimazole suppository can be used during pregnancy, but only under the supervision of a Physician.
","Constituents of the vaginal suppository may be incompatible with rubber in both contraceptive condoms and diaphragms. During period this treatment won't have good result. Avoid oral or ophthalmic use.
","Clotrimazole vaginal suppository is not recommended for paediatric use.
",,,,"Keep all medicines out of reach of children. Store in a cool & dry place, protected from light.
",10
+289,Clotrimazole (Topical),clotrimazole-topical-289,https://medex.com.bd/attachments/Bp1Kvq9jCvoHQ2VZUitsGmC0ncM8QN/clotrimazole-topical-creamlotionsolutionpowder-prescribing-information,Drugs for subcutaneous and mycoses,Superficial dermatophyte infections and pityriasis versicolor,"
+- All dermatomycoses due to dermatophytes (e.g.Trichophyton species).
+- All dermatomycoses due to yeasts (Candida species).
+- Dermatomycoses due to moulds and other fungi.
+- Skin diseases showing superinfections with these fungi.
+
+Some examples of skin infections
... Read more
+- All dermatomycoses due to dermatophytes (e.g.Trichophyton species).
+- All dermatomycoses due to yeasts (Candida species).
+- Dermatomycoses due to moulds and other fungi.
+- Skin diseases showing superinfections with these fungi.
+
+Some examples of skin infections included in above points are interdigital mycoses (e.g. athlete's foot), paronychias (associated with nail mycoses), mycoses in skin folds, Candida vulvitis, Candida balanitis, Pityriasis versicolor, erythrasma.
","Drugs for subcutaneous and mycoses, Topical Antifungal preparations
","Clotrimazole acts primarily by damaging the permeability barrier in the cell membrane of fungi. Clotrimazole causes inhibition of ergosterol biosynthesis, an essential constituent of fungal cell membranes. If ergosterol synthesis is either completely or partially inhibited, the cell is no longer able to construct an intact and functional cell membrane. Because ergosterol directly promotes the growth of fungal cells in a hormone‐like fashion, rapid onset of the above events leads to dose-dependent inhibition of fungal growth.
Though decreased ergosterol, due to the inhibition of lanosterol 14-demethylase (also known as CYP51) is accepted to be primarily responsible for the antimycotic properties of clotrimazole, this drug also shows other pharmacological effects. These include the inhibition of sarcoplasmic reticulum Ca2+ ATPase, depletion of intracellular calcium, and blocking of calcium‐dependent potassium channels and voltage‐dependent calcium channels. The action of clotrimazole on these targets accounts for other effects of this drug that are separate from its antimycotic activities.
","Clotrimazole Cream: This should be thinly applied 2-3 times daily to the infected sites and rubbed in. On account of the excellent efficacy, a small amount of cream is usually sufficient for an area about the size of the palm. For the treatment to become a complete success, reliable and sufficiently long-time application of Clotrimazole Cream is important. The duration of treatment varies; it depends among other factors on the extent and localization of the disease.
Recommended duration of treatment-
+
+- Dermatomycoses: 3-4 weeks
+- Candida vulvitis and Candida balanitis: 1-2 weeks
+- Erythrasma and Pityriasis Versicolor: 3 weeks (approximately)
+
+In fungal infection of the feet, to prevent relapse, treatment should be continued for about 2 weeks beyond the disappearance of all signs of disease. After washing, the feet should be thoroughly dried (particularly spaces between the toes). Clotrimazole Cream is odorless, can be washed off and does not stain clothing.
Clotrimazole topical solution: Apply this sparingly to the affected areas and rub in gently, two or three times daily.
",,"No information is available.
","Hypersensitivity to Clotrimazole.
","When applied topically, Clotrimazole is well tolerated.With external application, systemic effects are not observed. Local irritation or burning sensation may occur in a very few cases but these symptoms are not considered harmful.
","It is recommended that Clotrimazole should be used in pregnancy only when considered necessary by the physician.
",,,,,,"Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+287,Clotrimazole (Eye ointment),clotrimazole-eye-ointment-287,,Ophthalmic Anti-fungal Products,Fungal eye infections,"Clotrimazole Sterile Eye Ointment is indicated for the treatment of fungal keratitis due to filamentous fungi and Candida species.
","Ophthalmic Anti-fungal Products
","Clotrimazole kills fungi and yeasts by interfering with their cell membranes. It works by stopping the production of ergosterol, which is an essential component of fungal cell membranes resulting in increased membrane permeability and leakage of essential constituents of the fungal cells.
","Eye ointment: It should be applied thinly and evenly to the conjunctival sac every 4 hours daily or as advised by a physician.
",,,"Clotrimazole ointment is contraindicated in individuals sensitive to its components.
","Rarely patients may experience burning or irritation immediately after applying the ointment.
","Pregnancy category B. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. Clotrimazole should be used only if clearly indicated during the first trimester of pregnancy.
It is not known whether this drug is excreted in human milk, caution should be exercised when Clotrimazole is used by a nursing woman.
","If irritation or sensitivity develops with the use of Clotrimazole ointment, treatment should be discontinued.
","Une in children: Safety and effectiveness in children have been established for Clotrimazole when used as indicated and in the recommended dosage.
",,,,,9
+288,Clotrimazole (Ear drop),clotrimazole-ear-drop-288,,Aural Anti-fungal preparations,Fungal infections,"Clotrimazole Ear Drop is indicated for the treatment of fungal infections of the ear.
","Aural Anti-fungal preparations
","Clotrimazole kills fungi and yeasts by interfering with their cell membranes. It works by stopping the production of ergosterol, which is an essential component of fungal cell membranes resulting in increased membrane permeability and leakage of essential constituents of the fungal cells.
","Instill 2-3 drops of Clotrimazole Ear Drops in the affected ear two or three times daily. The treatment should be continued for at least two weeks after the disappearance of all signs of infection to prevent re-infection.
",,"There have been reports of a heat reaction when this medication used concomitantly with Sofradex drops in the ear.
","Individuals who have hypersensitivity to any of its components.
","Clotrimazole is generally well tolerated after local application but the few side effects have been reported infrequently like erythema, stinging, edema, pruritus and general irritation.
","Clotrimazole is recommended during pregnancy only after first consulting a doctor. Because systemic absorption of clotrimazole following topical application is marginal, there should be no risk for the infant during lactation.
","If local intolerance develops, consider withdrawal of the medicine and institution of appropriate therapy. Clotrimazole ear drop is not intended for ophthalmic use.
",,"In case of accidental oral ingestion, supportive measures should be taken.
",,,"Protect from light, store in cool & dry place. Keep out of the reach of children. Protect from freezing. Do not use more than 4 weeks after opening.
",11
+2071,Dacomitinib,dacomitinib-2071,https://medex.com.bd/attachments/SfOilcgi0PmoNrthRO7O47kEENCMJc/dacomitinib-prescribing-information,Cytotoxic Chemotherapy,Metastatic non-small cell lung cancer,"Dacomitinib is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.
","Cytotoxic Chemotherapy
","Dacomitinib is an irreversible inhibitor of the kinase activity of the human EGFR family (EGFR/HER1, HER2, and HER4) and certain EGFR activating mutations (exon 19 deletion or the exon 21 L858R substitution mutation). In vitro dacomitinib also inhibited the activity of DDR1, EPHA6, LCK, DDR2, and MNK1 at clinically relevant concentrations. Dacomitinib demonstrated dose-dependent inhibition of EGFR and HER2 autophosphorylation and tumor growth in mice bearing subcutaneously implanted human tumor xenografts driven by HER family targets including mutated EGFR. Dacomitinib also exhibited antitumor activity in orally-dosed mice bearing intracranial human tumor xenografts driven by EGFR amplifications.
","The recommended dosage of Dacomitinib is 45 mg taken orally once daily, until disease progression or unacceptable toxicity occurs. Dacomitinib can be taken with or without food. Take Dacomitinib the same time each day. If the patient vomits or misses a dose, do not take an additional dose or make up a missed dose but continue with the next scheduled dose. First dose reduction Dose Level-30 mg Dose (Once Daily) Second dose reduction Dose Level-15 mg Dose.
",,"Proton Pump Inhibitors (PPIs): Avoid use with DACOMITINIB; use locally-acting antacids or H2-receptor antagonist; administer DACOMITINIB at least 6 hours before or 10 hours after H2-receptor antagonist
CYP2D6 Substrates: Avoid concomitant use with DACOMITINIB where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities
",,"Most common adverse reactions (incidence >20%) are diarrhea, rash, paronychia, stomatitis, decreased appetite, dry skin, decreased weight, alopecia, cough, and pruritus.
","Dacomitinib can cause fetal harm when administered to a pregnant woman. There is no information regarding the presence of dacomitinib or its metabolites in human milk or their effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in breastfed infants from Dacomitinib, advise women not to breastfeed during treatment with Dacomitinib and for at least 17 days after the last dose.
","Interstitial Lung Disease (ILD): Permanently discontinue Dacomitinib if ILD is confirmed
Diarrhea: Withhold and reduce the dose of DACOMITINIB based on the severity
Dermatologic Adverse Reactions: Withhold and reduce the dose of DACOMITINIB based on the severity
Embryo-Fetal Toxicity: Dacomitinib can cause fetal harm. Advise females of reproductive potential to use effective contraception.
","Pediatric Use: The safety and effectiveness of Dacomitinib in pediatrics have not been established.
Renal Impairment: No dosage modification is recommended for patients with mild or moderate renal impairment (ClCr 30 to 89 mL/min estimated by Cockcroft-Gault). The recommended dose of Dacomitinib has not been established for patients with severe renal impairment (ClCr<30 mL/min)
",,,,"Do not store above 30⁰C. Keep away from light and out of the reach of children.
",10
+1302,Daclatasvir + Sofosbuvir,daclatasvir-sofosbuvir-1302,,Hepatic viral infections (Hepatitis C),Direct acting antiviral agent (DAA) against the hepatitis C virus,"Sofosbuvir directly targets the Hepatitis C virus to stop it from making copies of itself in the liver. Sofosbuvir attaches itself to the genetic information, called RNA, to block the virus from multiplying. And Daclatasvir is a direct-acting antiviral agent (DAA) against the hepatitis C virus.
","Hepatic viral infections (Hepatitis C)
","Sofosbuvir is an inhibitor of the hepatitis C virus (HCV) NS5B ribonucleic acid (RNA)-dependent RNA polymerase, which is essential for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator. In a biochemical assay, GS-461203 inhibited the polymerase activity of the recombinant NS5B from HCV genotype 1b, 2a, 3a and 4a with a 50% inhibitory concentration (IC50) value ranging from 0.7-2.6 micrometer. GS-461203 (the active metabolite of sofosbuvir) is not an inhibitor of human deoxyribonucleic acid (DNA) and RNA polymerases, nor an inhibitor of mitochondrial RNA polymerase.
Daclatasvir stops HCV viral RNA replication and protein translation by directly inhibiting HCV protein NS5A. NS5A is critical for HCV viral transcription and translation.
",,,,,,,,,,,,,3
+316,Daclatasvir,daclatasvir-316,https://medex.com.bd/attachments/Xl0vIvizIMjfMQHQi1Uw0K0rzvLrUx/daclatasvir-prescribing-information,Hepatic viral infections (Hepatitis C),Chronic hepatitis C,"Daclatasvir is indicated in combination with Sofosbuvir for the treatment of chronic hepatitis C virus (HCV) infection in adults.
","Hepatic viral infections (Hepatitis C)
","Daclatasvir is a direct acting antiviral agent (DAA) against the Hepatitis C Virus (HCV). Daclatasvir is an inhibitor of NS5A, a nonstructural protein encoded by HCV. Daclatasvir binds to the N-terminus of NS5A and inhibits both viral RNA replication and virion assembly. Characterization of Daclatasvir-resistant viruses, biochemical studies, and computer modeling data indicate that Daclatasvir interacts with the N-terminus within Domain 1 of the protein, which may cause structural distortions that interfere with NS5A functions.
","Recommended Dosage: The recommended dose of Daclatasvir is 60 mg once daily, to be taken orally with or without meals.
Daclatasvir must be administered in combination with other medicinal products. The Summary of Product Characteristics for the other medicinal products in the regimen should also be consulted before initiation of therapy with Daclatasvir. Recommended regimens and treatment duration are provided in table below:
For the regimen of Daclatasvir+Sofosbuvir, data for 12-week treatment duration are available only for treatment-naïve patients with genotype 1 infection. For Daclatasvir+Sofosbuvir with or without Ribavirin, data are available for patients with advanced liver disease (≥F3) without cirrhosis. The recommended use of Daclatasvir+Sofosbuvir in genotype 4 is based on extrapolation from genotype 1. For the regimen of Daclatasvir+Peginterferon alfa + Ribavirin, data are available for treatment-naïve patients.
+
+- The dose of Ribavirin, when combined with Daclatasvir, is weight-based (1,000 or 1,200 mg in patients <75 kg or ≥75 kg, respectively).
+- Dose modification, interruption and discontinuation: Dose modification of Daclatasvir to manage adverse reactions is not recommended. If treatment interruption of components in the regimen is necessary because of adverse reactions, Daclatasvir must not be given as monotherapy.
+- There are no virologic treatment stopping rules that apply to the combination of Daclatasvir with Sofosbuvir.
+- Treatment discontinuation in patients with inadequate on-treatment virologic response during treatment with Daclatasvir, Peginterferon alfa and Ribavirin.
+
+Dose recommendation for concomitant medicines:
+
+- Strong inhibitors of cytochrome P450 enzyme 3A4 (CYP3A4): The dose of Daclatasvir should be reduced to 30 mg once daily when coadministered with strong inhibitors of CYP3A4.
+- Moderate inducers of CYP3A4: The dose of Daclatasvir should be increased to 90 mg once daily when coadministered with moderate inducers of CYP3A4.
+- Missed doses: Patients should be instructed that, if they miss a dose of Daclatasvir, the dose should be taken as soon as possible if remembered within 20 hours of the scheduled dose time. However, if the missed dose is remembered more than 20 hours after the scheduled dose, the dose should be skipped and the next dose taken at the appropriate time.
+
",,"Potential for Other Drugs to Affect Daclatasvir: Daclatasvir is a substrate of CYP3A. Therefore, moderate or strong inducers of CYP3A may decrease the plasma levels and therapeutic effect of Daclatasvir. Strong inhibitors of CYP3A (eg, clarithromycin, itraconazole, ketoconazole, ritonavir) may increase the plasma levels of Daclatasvir.
Potential for Daclatasvir to Affect Other Drugs: Daclatasvir is an inhibitor of P-glycoprotein transporter (P-gp), organic anion transporting polypeptide (OATP) 1B1 and 1B3, and breast cancer resistance protein (BCRP). Administration of Daclatasvir may increase systemic exposure to medicinal products that are substrates of P-gp, OATP 1B1 or 1B3, or BCRP, which could increase or prolong their therapeutic effect or adverse reaction.
","Daclatasvir is contraindicated in combination with drugs that strongly induce CYP3A and, thus, may lead to lower exposure and loss of efficacy of Daclatasvir. Contraindicated drugs include, but are not limited to, Anticonvulsants (phenytoin, carbamazepine), Antimycobacterial agents (rifampin), Herbal Products st.Jhon’s wort (Hypericum perforatum).
","The following serious adverse reactions are described below and elsewhere in the labeling: Serious Symptomatic Bradycardia When Coadministered with Sofosbuvir and Amiodarone. One can get any of the following symptoms: Fainting or near-fainting, dizziness or lightheadedness, not feeling well, weakness, tiredness, shortness of breath, chest pain, confusion, memory problems.
","No data with Daclatasvir in pregnant women are available to inform a drug-associated risk. No information regarding the presence of Daclatasvir in human milk, the effects on the breastfed infant, or the effects on milk production is available.
","Risk of adverse reactions or loss of virologic response due to drug interactions. The concomitant use of Daclatasvir and other drugs may result in known or potentially significant drug interactions, some of which may lead to:
+
+- loss of therapeutic effect of Daclatasvir and possible development of resistance
+- dosage adjustments of concomitant medications or Daclatasvir
+- possible clinically significant adverse reactions from greater exposures of concomitant drugs or Daclatasvir
+
+
Serious Symptomatic Bradycardia When Coadministered with Sofosbuvir and Amiodarone and patients counseling: Postmarketing cases of symptomatic bradycardia and cases requiring pacemaker intervention have been reported when Amiodarone is coadministered with Sofosbuvir in combination with another HCV direct-acting antiviral, including Daclatasvir. Patients who are taking Sofosbuvir in combination with Daclatasvir who need to start Amiodarone therapy due to no other alternative treatment options should undergo cardiac monitoring.
","Elderly: No dose adjustment of Daclatasvir is required for patients aged ≥65 years.
Renal impairment: No dose adjustment of Daclatasvir is required for patients with any degree of renal impairment.
Hepatic impairment: No dose adjustment of Daclatasvir is required for patients with mild (Child-Pugh A, score 5-6), moderate (Child-Pugh B, score 7-9) or severe (Child-Pugh C, score ≥10) hepatic impairment.
Paediatric population: The safety and efficacy of Daclatasvir in children and adolescents aged below 18 years have not yet been established. No data are available.
","There is no known antidote for overdose of Daclatasvir. Treatment of overdose with Daclatasvir should consist of general supportive measures, including monitoring of vital signs and observation of the patient’s clinical status. Because Daclatasvir is highly protein bound (>99%), dialysis is unlikely to significantly reduce plasma concentrations of the drug.
",,,"Store at room temperature below 30°C, protect from light. keep out of the reach of children.
",12
+1388,Dacarbazine,dacarbazine-1388,https://medex.com.bd/attachments/EmvpfJReC9L76l42xmmNGk3nbl04tV/dacarbazine-prescribing-information,Cytotoxic Chemotherapy,Metastatic melanoma,"Dacarbazine is indicated in the treatment of metastatic malignant melanoma. In addition, Dacarbazine is also indicated for Hodgkin’s disease as a second-line therapy when used in combination with other effective agents
","Cytotoxic Chemotherapy
","Dacarbazine is a non-cell cycle specific antineoplastic agent. The exact mechanism of action by which it exerts cytotoxic effects is still unclear. However, three possible mechanisms have been postulated, including inhibition of DNA synthesis by acting as a purine analog, action as an alkylating agent, and interaction with sulfydryl group in the inhibition of bacterial cell growth.
","Malignant Melanoma: The recommended dosage is 2 to 4.5 mg/kg/day for 10 days. Treatment may be repeated at 4 week intervals. An alternate recommended dosage is 250 mg/m2/day IV for 5 days. Treatment may be repeated every 3 weeks.
Hodgkin’s Disease: The recommended dosage of Dacarbazine in the treatment of Hodgkin’s disease is 150 mg/m2/day for 5 days, in combination with other effective drugs. Treatment may be repeated every 4 weeks. An alternative recommended dosage is 375 mg/m2 on day 1, in combination with other effective drugs, to be repeated every 15 days.
",,"Increased metabolism when used with enzyme inducers (e.g. barbiturates, rifampicin, phenytoin). May potentiate the effect of mercaptopurine, azathioprine, allopurinol. May impair immune response to vaccines. May enhance the effects of methoxsalen due to photosensitisation.
","Dacarbazine is contraindicated in patients who have demonstrated a hypersensitivity to it in the past.
","Symptoms of anorexia, nausea and vomiting are the most frequently noted of all toxic reactions. Over 90% of patients are affected with the initial few doses. The vomiting lasts 1 to 12 hours and is incompletely and unpredictably palliated with phenobarbital and/or prochlorperazine. Rarely, intractable nausea and vomiting have necessitated discontinuance of therapy with Dacarbazine for Injection. Rarely, Dacarbazine for Injection has caused diarrhea. Some helpful suggestions include restricting the patient’s oral intake of food for 4 to 6 hours prior to treatment. The rapid toleration of these symptoms suggests that a central nervous system mechanism may be involved, and usually these symptoms subside after the first 1 or 2 days.
","Pregnancy Category C. Dacarbazine for Injection has been shown to be teratogenic in rats when given in doses 20 times the human daily dose on day 12 of gestation. Dacarbazine when administered in 10 times the human daily dose to male rats (twice weekly for 9 weeks) did not affect the male libido, although female rats mated to male rats had higher incidence of resorptions than controls. In rabbits, dacarbazine daily dose 7 times the human daily dose given on Days 6 to 15 of gestation resulted in fetal skeletal anomalies. There are no adequate and well controlled studies in pregnant women. Dacarbazine for Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for tumorigenicity shown for Dacarbazine for Injection in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","Hospitalization is not always necessary but adequate laboratory study capability must be available. Extravasation of the drug subcutaneously during intravenous administration may result in tissue damage and severe pain. Local pain, burning sensation and irritation at the site of injection may be relieved by locally applied hot packs. Carcinogenicity of dacarbazine was studied in rats and mice. Proliferative endocardial lesions, including fibrosarcomas and sarcomas were induced by dacarbazine in rats. In mice, administration of dacarbazine resulted in the induction of angiosarcomas of the spleen.
",,"Give supportive treatment and monitor blood cell counts.
",,"Dacarbazine 200 mg/vial is reconstituted with 19.7 mL of Sterile Water for Injection. The resulting solution contains 10 mg/mL of dacarbazine having a pH of 3.0 to 4.0. The calculated dose of the resulting solution is drawn into a syringe and administered only intravenously. The reconstituted solution may be further diluted with 5% dextrose injection or sodium chloride injection and administered as an intravenous infusion. After reconstitution and prior to use, the solution in the vial may be stored at 4°C for up to 72 hours or at normal room conditions (temperature and light) for up to 8 hours. If the reconstituted solution is further diluted in 5% dextrose injection or sodium chloride injection, the resulting solution may be stored at 4°C for up to 24 hours or at normal room conditions for up to 8 hours. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. There is no general agreement that all the procedures recommended in the guidelines are necessary or appropriate.
","Store in a refrigerator 2°C to 8°C
",12
+1304,Dabigatran Etexilate Mesylate,dabigatran-etexilate-mesylate-1304,https://medex.com.bd/attachments/wO5Oste9W3tKlzU5sSEWGt9uCDXRti/dabigatran-etexilate-mesylate-prescribing-information,Fibrinolytics (Thrombolytics),Stroke,"Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation: Dabigatran Etexilate Mesylate is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
Treatment of Deep Venous Thrombosis and Pulmonary Embolism ... Read more
Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation: Dabigatran Etexilate Mesylate is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
Treatment of Deep Venous Thrombosis and Pulmonary Embolism: Dabigatran Etexilate Mesylate is indicated for the treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5-10 days.
Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism: Dabigatran Etexilate Mesylate is indicated to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in patients who have been previously treated.
Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism Following Hip Replacement Surgery: Dabigatran Etexilate Mesylate is indicated for the prophylaxis of deep vein thrombosis and pulmonary embolism, in patients who have undergone hip replacement surgery.
","Anti-coagulants, Anti-platelet drugs, Fibrinolytics (Thrombolytics)
","Dabigatran and its acyl glucuronides are competitive, direct thrombin inhibitors. Because thrombin (serine protease) enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of a thrombus. Both free and clot-bound thrombin, and thrombin-induced platelet aggregation are inhibited by the active moieties.
At recommended therapeutic doses, dabigatran etexilate prolongs the coagulation markers such as aPTT, ECT, and TT. INR is relatively insensitive to the exposure to dabigatran and cannot be interpreted the same way as used for warfarin monitoring. The aPTT test provides an approximation of Dabigatran Etexilate’s anticoagulant effect. The average time course for effects on aPTT, following approved dosing regimens in patients with various degrees of renal impairment is shown in Figure 2. The curves represent mean levels without confidence intervals; variations should be expected when measuring aPTT. While advice cannot be provided on the level of recovery of aPTT needed in any particular clinical setting, the curves can be used to estimate the time to get to a particular level of recovery, even when the time since the last dose of Dabigatran Etexilate is not precisely known. In the RE-LY trial, the median (10 th to 90 th percentile) trough aPTT in patients receiving the 150 mg dose was 52 (40 to 76) seconds.
","Reduction in Risk of Stroke and Systemic Embolism in Non-valvular AF-
+
+- CrCl >30 mL/min: 150 mg twice daily
+- CrCl 15 to 30 mL/min: 75 mg twice daily
+- CrCl <15 mL/min or on dialysis: Dosing recommendations cannot be provided
+- CrCl 30 to 50 mL/min with concomitant use of P-gp inhibitors: Reduce dose to 75 mg twice daily if given with P-gp inhibitors dronedarone or systemic ketoconazole.
+- CrCl <30 mL/min with concomitant use of P-gp inhibitors: Avoid co-administration
+
+Treatment of DVT and PE, Reduction in the Risk of Recurrence of DVT and PE-
+
+- CrCl >30 mL/min: 150 mg twice daily
+- CrCl ≤30 mL/min or on dialysis: Dosing recommendations cannot be provided
+- CrCl <50 mL/min with concomitant use of P-gp inhibitors: Avoid co-administration
+
+Prophylaxis of DVT and PE Following Hip Replacement Surgery-
+
+- CrCl >30 mL/min: 110 mg for first day, then 220 mg once daily
+- CrCl ≤30 mL/min or on dialysis: Dosing recommendations cannot be provided
+- CrCl <50 mL/min with concomitant use of P-gp inhibitors: Avoid co-administration.
+
+
Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation: For patients with creatinine clearance (CrCl) >30 mL/min, the recommended dose of Dabigatran Etexilate is 150 mg taken orally, twice daily. For patients with severe renal impairment (CrCl 15-30 mL/min), the recommended dose of Dabigatran Etexilate is 75 mg twice daily. Dosing recommendations for patients with a CrCl <15 mL/min or on dialysis cannot be provided.
Treatment of Deep Venous Thrombosis and Pulmonary Embolism: For patients with CrCl >30 mL/min, the recommended dose of Dabigatran Etexilate is 150 mg taken orally, twice daily, after 5-10 days of parenteral anticoagulation. Dosing recommendations for patients with a CrCl ≤30 mL/min or on dialysis cannot be provided.
Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism: For patients with CrCl >30 mL/min, the recommended dose of Dabigatran Etexilate is 150 mg taken orally, twice daily after previous treatment. Dosing recommendations for patients with a CrCl ≤30 mL/min or on dialysis cannot be provided.
Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism Following Hip Replacement Surgery: For patients with CrCl >30 mL/min, the recommended dose of Dabigatran Etexilate is 110 mg taken orally 1-4 hours after surgery and after hemostasis has been achieved, then 220 mg taken once daily for 28-35 days. If Dabigatran Etexilate is not started on the day of surgery, after hemostasis has been achieved initiate treatment with 220 mg once daily. Dosing recommendations for patients with a CrCl ≤30 mL/min or on dialysis cannot be provided
",,"Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation: The concomitant use of Dabigatran Etexilate with P-gp inducers (e.g., rifampin) reduces exposure to dabigatran and should generally be avoided. P-gp inhibition and impaired renal function are the major independent factors that result in increased exposure to dabigatran. Concomitant use of P-gp inhibitors in patients with renal impairment is expected to produce increased exposure of dabigatran compared to that seen with either factor alone. In patients with moderate renal impairment (CrCl 30-50 mL/min), reduce the dose of Dabigatran Etexilate to 75 mg twice daily when administered concomitantly with the P-gp inhibitors dronedarone or systemic ketoconazole. The use of the P-gp inhibitors verapamil, amiodarone, quinidine, clarithromycin, and ticagrelor does not require a dose adjustment of Dabigatran Etexilate. These results should not be extrapolated to other P-gp inhibitors. The concomitant use of Dabigatran Etexilate and P-gp inhibitors in patients with severe renal impairment (CrCl 15-30 mL/min) should be avoided.
Treatment and Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism: Avoid use of Dabigatran Etexilate and P-gp inhibitors in patients with CrCl <50 mL/min.
Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism Following Hip Replacement Surgery: In patients with CrCl ≥50 mL/min who have concomitant administration of P-gp inhibitors such as dronedarone or systemic ketoconazole, it may be helpful to separate the timing of administration of dabigatran and the P-gp inhibitor by several hours. The concomitant use of Dabigatran Etexilate and P-gp inhibitors in patients with CrCl <50 mL/min should be avoided.
","Dabigatran Etexilate is contraindicated in patients with:
+
+- Active pathological bleeding.
+- History of a serious hypersensitivity reaction to Dabigatran Etexilate (e.g., anaphylactic reaction or anaphylactic shock).
+- Mechanical prosthetic heart valve.
+
","The following clinically significant adverse reactions are described elsewhere in the labeling:
+
+- Increased Risk of Thrombotic Events after Premature Discontinuation
+- Risk of Bleeding
+- Spinal/Epidural Anesthesia or Puncture
+- Thromboembolic and Bleeding Events in Patients with Prosthetic Heart Valves
+- Increased Risk of Thrombosis in Patients with Triple-Positive Antiphospholipid Syndrome
+
","Pregnancy: The limited available data on Dabigatran Etexilate use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes. There are risks to the mother associated with untreated venous thromboembolism in pregnancy and a risk of hemorrhage in the mother and fetus associated with the use of anticoagulant
Lactation: There are no data on the presence of dabigatran in human milk, the effects on the breastfed child, or on milk production. Dabigatran and/or its metabolites were present in rat milk. Breastfeeding is not recommended during treatment with Dabigatran Etexilate.
","Bleeding: Dabigatran Etexilate can cause serious and fatal bleeding
Bioprosthetic heart valves: Dabigatran Etexilate use not recommended
Increased Risk of Thrombosis in Patients with Triple-Positive Antiphospholipid Syndrome: Dabigatran Etexilate use not recommended
","Pediatric Use: The safety and effectiveness of Dabigatran Etexilate in pediatric patients have not been established.
Geriatric Use: Of the total number of patients in the RE-LY study, 82% were 65 and over, while 40% were 75 and over. The risk of stroke and bleeding increases with age, but the risk-benefit profile is favorable in all age groups.
","Accidental overdose may lead to hemorrhagic complications. In the event of hemorrhagic complications, initiate appropriate clinical support, discontinue treatment with Dabigatran Etexilate, and investigate the source of bleeding. A specific reversal agent (idarucizumab) is available. Dabigatran is primarily eliminated by the kidneys with a low plasma protein binding of approximately 35%. Hemodialysis can remove dabigatran; however, data supporting this approach are limited. Using a high-flux dialyzer, blood flow rate of 200 mL/min, and dialysate flow rate of 700 mL/min, approximately 49% of total dabigatran can be cleared from plasma over 4 hours. At the same dialysate flow rate, approximately 57% can be cleared using a dialyzer blood flow rate of 300 mL/min, with no appreciable increase in clearance observed at higher blood flow rates. Upon cessation of hemodialysis, a redistribution effect of approximately 7% to 15% is seen. The effect of dialysis on dabigatran’s plasma concentration would be expected to vary based on patient specific characteristics. Measurement of aPTT or ECT may help guide therapy
",,,"Store Dabigatran Etexilate at room temperature 20°C to 25°C. After opening the bottle, use Dabigatran Etexilate within 4 months. Safely throw away any unused Dabigatran Etexilate after 4 months. Keep Dabigatran Etexilate in the original bottle or blister package to keep it dry (protect the capsules from moisture). Do not put Dabigatran Etexilate in pill boxes or pill organizers. Tightly close your bottle of Dabigatran Etexilate right away after you take your dose. Keep Dabigatran Etexilate and all medicines out of the reach of children.
",12
+1790,D-chiro-inositol,d-chiro-inositol-1790,https://medex.com.bd/attachments/4pWAMj7Yz8pEji22HtsO63dABvDeer/d-chiro-inositol-prescribing-information,Trophic Hormones & Related Synthetic Drugs,Polycystic ovarian syndrome,"D-chiro-inositol capsule is indicated for the treatment and prevention of-
+
+- Polycystic ovary syndrome (PCOS)
+- Anovulation
+- Menstrual disorders such as amenorrhea
+- Hyperandrogenism complaints such as hirsutism,
+- Alopecia, acanthosis nigricans, acne
+- Ovarian hyperthecosis.
+
","Trophic Hormones & Related Synthetic Drugs
","D-chiro-inositol is extracted by a patented process from Carob (Ceratonia siliqua) pod that mostly found in Southern Europe. Deficiency of D-chiro-inositol in peripheral tissue causes insulin resistance that leads to hyperandrogenism in ovaries which results polycystic ovary syndrome (PCOS). D-chiro-inositol helps to regulate the balance between androgen and estrogen by decreasing luteinizing hormone and serum testosterone level. It improves glucose tolerance and reduces circulating insulin. It reduces oxidative stress on follicle and decreases total cholesterol and triglyceride levels. D-chiro-inositol has been clinically proven as an effective treatment of ovarian cyst and PCOS associated metabolic disorders. It helps to improve and regulate normal ovulation after two weeks of administration. It also reduces hyperandrogenism related skin disorders like hirsutism, alopecia, acanthosis nigricans and acne. It lowers cardiovascular risk in women who are suffering from PCOS by controlling arterial pressure.
","Orally 1-2 capsules daily or as advised by the physician. Duration of the treatment should be minimum 2 months.
",,"Concurrent use with digoxin may result in increased digoxin toxicity.
","Contraindicated in patient with known hypersensitivity to D-chiro-inositol.
","Well tolerated in recommended dose.
","Several human studies have been conducted with inositol has no clinically relevant adverse effects.
",,,,,,"Store at temperature of below 30˚C, protect from light & moisture. Keep out of reach of children.
",9
+315,Cytarabine,cytarabine-315,https://medex.com.bd/attachments/6nmdbnai4c8NHta2ra2cY7eA4ALGDS/cytarabine-prescribing-information,Cytotoxic Chemotherapy,Non-Hodgkin lymphoma,"Cytarabine is indicated in Leukaemic meningitis, Induction and maintenance of remission in acute leukaemias
","Cytotoxic Chemotherapy
","Cytarabine inhibits deoxyribonucleic acid (DNA) synthesis specifically at the S-phase of the cell cycle. It also has an antiviral and immunosuppressant activity.
","Intrathecal (Adult)-
+
+- Leukaemic meningitis: 5-75 mg/m2 or 30-100 mg once every 2-7 days to once daily for 4 or 5 days.
+- For lymphomatous meningitis: 50 mg every 2 wk for 5 doses, then every 4 wk for 5 doses.
+
+Parenteral (Adult)-
Induction and maintenance of remission in acute leukaemias:
+
+- As monotherapy: 200 mg/m2 daily by continuous IV infusion for 5 days, at intervals of approx 2 wk.
+- In combination therapy: 100 mg/m2 bid by rapid IV inj or 100 mg/m2 daily by continuous IV infusion both for 7 days. Maintenance: 1-1.5 mg/kg once or twice wkly via IV or SC.
+
",,"May reduce efficacy of 5-fluorocytosine, digoxin, gentamicin. May increase risk of neurotoxicity with other cytotoxic agents (intrathecal).
","Patient with active meningeal infection.
","Nausea, vomiting, fever, rash, diarrhoea, anorexia, oral and anal inflammation or ulceration, hepatic dysfunction, headache, weakness, confusion, thrombocytopenia, fatigue.
","Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Patient with previous drug-induced bone marrow suppression. Renal or hepatic impairment. Pregnancy and lactation.
",,"Symptoms: Irreversible CNS toxicity and death. Severe arachnoiditis including encephalopathy.
Management: Therapy cessation followed by treatment of ensuing bone marrow depression including whole blood or platelet transfusion and antibiotics. Maintain vital functions.
",,"Intravenous: Reconstitute with bacteriostatic water for inj (standard-dose), further dilute in 250-1,000 ml NaCl 0.9% or dextrose 5% in water for infusion.
Intrathecal: Reconstitute with preservative free NaCl 0.9%, further dilute with Elliot’s B soln, NaCl 0.9% or lactated Ringer’s inj to preferred final vol (up to 12 ml).
","IV/SC: Store between 15-25°C. Intrathecal: Store between 2-8°C. Avoid freezing.
",12
+324,Cyproterone Acetate + Ethinyl Estradiol,cyproterone-acetate-ethinyl-estradiol-324,https://medex.com.bd/attachments/R9yTVJbJ1zYSojQAV63RtAvLhXvbcD/cyproterone-acetate-ethinyl-estradiol-prescribing-information,Oral Hormonal preparations for Acne,Prostate carcinoma,"For the treatment of women with severe acne, unresponsive to oral antibiotic and other available treatments, with associated symptoms of androgenization, including seborrhea and mild hirsutism.
","Oral Contraceptive preparations, Oral Hormonal preparations for Acne
","Cyproterone is a steroid compound with potent antiandrogenic, progestogenic and antigonadotrophic activity. It exerts its antiandrogenic effect by blocking androgen receptors. It also reduces androgen synthesis by a negative feedback effect on the hypothalamo-pituitary-ovarian systems. The estrogen component (Ethinylestradiol) increases levels of sex hormone binding globulin (SHBG) and thus reduces the free circulating plasma levels of androgens. Cyproterone has no tendency to reduce SHBG levels.
If used alone in women,Cyproterone leads to menstrual cycle disturbances which are avoided when combined with Ethinylestradiol. When this tablet is administered in a cyclic manner, it has the added effect of preventing ovulation and possible conception.
The components of this tablet are rapidly absorbed after oral administration. Due to the long terminal half-life of Cyproterone, a 4-fold increase in plasma levels occurs after 6 to 12 days of daily dosing. Long-term therapy (36 months) with this product did not have a significant influence on lipid metabolism. A trend to increase plasma cholesterol and triglyceride levels was observed. There was a slight decrease in low density lipoprotein (LDL) with a simultaneous increase in high density lipoprotein (HDL).
","This tablet should not be prescribed solely for its contraceptive properties. If patient compliance is uncertain and contraception is necessary, then a supplementary nonhormonal contraceptive method should be considered.
First Treatment Course: The patient is instructed to take 1 tablet daily for 21 consecutive days beginning on day 1 of her menstrual cycle. (For the first cycle only the first day of menstrual flow is considered Day 1). The tablets are then discontinued for 7 days (1 week). Withdrawal bleeding should usually occur during the period that the patient is off the tablets.The first cycle will be somewhat shorter than usual, whereas all following cycles will last 4 weeks. The patient should be instructed to take the first tablet from the blister pack out of the section marked with the corresponding day (for example ""Mon"" for Monday) of the week and swallow it with some liquid. The patient should be instructed to take the tablet at the same time each day.
Subsequent Courses: The patient begins her next and all subsequent 21-day course of tablets (following the same 21 days on, 7 days off) on the same day of the week that she began her first course. She begins taking her tablets 7 days after discontinuation,regardless of whether or not withdrawal bleeding is still in progress.
Treatment should be continued for several months,since improvement may not be observed for at least 3 months. The need to continue treatment with This tablet should be evaluated periodically by the treating physician. This drug should be discontinued 3 to 4 cycles after signs have completely resolved.
Pregnancy should be ruled out before continuing treatment with This tablet in patients who have missed a menstrual period, if pregnancy is suspected, medication should be discontinued.
Missed dose: If the patient forgets to take a tablet at the usual time, the tablet may be taken within the next 12 hours. If more than 12 hours have elapsed from the time of usual administration, the patient must discard the missed tablet and continue to take the remaining tablets in the pack at the usual time in order to avoid premature withdrawal bleeding during this cycle. A supplementary nonhormonal method of contraception must be employed until the pack is empty to prevent pregnancy which would necessitate immediate discontinuation of this treatment.
",,"Concurrent use of the following drugs may result in reduced efficacy of this tablet and increased incidence of breakthrough bleeding: Ampicillin, Analgesics, Antihistamines, Antimigraine preparations, Chloramphenicol, Griseofulvin, Isoniazid, Neomycin, Nitrofurantain, Penicillin V, Phenylbutazone, Sulfonamides and Tetracycline.
Concurrent use of anticoagulants with estrogen/progestogen combinations may reduce the anticoagulant effect. Effectiveness of the following drugs may be altered when used concurrently: Antihypertensive, Benzodiazepines (those that undergo oxidative degradation), Beta-adrenergic blockers,Caffeine, Corticosteroids, Hypoglycemic, Phenothiazine, Theophylline, Tricyclic antidepressants and Vitamins.
Concurrent use of the following drugs may reduce the efficacy of this tablet because of accelerated estrogen metabolism caused by the induction of hepatic enzymes: Carbamazepine, Phenobarbital, Phenytoin, Pyrimidine and Rifampicin.
Diabetics using estrogen/progestogen combinations may require adjustment of their antidiabetic medication. Concurrent administration of vitamin C (ascorbic acid) with estrogen/ progestogen combinations has been reported to result in a significant rise in plasma Ethinylestradiol levels.
Rule out pregnancy before treatment is begun. Because of the antiandrogenic action of this tablet,feminization of male fetuses has occurred in animal studies and may possibly occur in humans.
","
+- Thrombophlebitis, thromboembolic disorders, or a history of these conditions
+- Cerebrovascular disorders
+- Myocardial infarction or coronary artery diseases
+- Active liver disease or hepatic adenomas or carcinomas
+- History of cholestatic jaundice
+- Known or suspected carcinoma of the breast
+- Known or suspected estrogen-dependent neoplasia
+- Undiagnosed abnormal vaginal bleeding
+- Any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields
+- When pregnancy is suspected or diagnosed
+- Previous or existing liver tumors
+- Severe diabetes with vascular changes
+- A history of otosclerosis with deterioration during pregnancy.
+
","Common side effects are Bleeding, Dizziness, Depression, Weight gain, Headache, Edema, Breast pain, Lactation, Blood clot, Gallstones.
.
","Fetal abnormalities have been reported to occur in the offspring of women who have taken estrogen/progestogen combinations in early pregnancy. Rule out pregnancy as soon as it is suspected. The use of estrogen/progestogen combinations during the period a mother is breast-feeding her infant may not be advisable. The hormonal components are excreted in breast milk and may reduce its quantity and quality. The long-term effects on the developing child are not known. This drug may cause fluid retention, conditions such as epilepsy.
","Predisposing Factors for Coronary Artery Diseases: In women with predisposing factors for coronary artery disease (such as cigarette smoking, hypertension; hypercholesterolemia, obesity, diabetes and increasing age), the use of estrogen or progestogen combinations have been reported as an additional risk factor. After the age of 35 years, estrogen or progestogen combinations should be considered only in exceptional circumstances and when the risk/benefit ratio has been carefully weighed by both the patient and the physician. Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from the use of this class of medication. This risk increases with age and heavy smoking (15 or more cigarettes per day) and is more marked in women over 35 years of age. Women who use such medication should not smoke. Estrogen/progestogen combinations may cause an increase in plasma lipoproteins and should be administered with caution to women known to have pre-existent hyperlipoproteinemia. Lipid profiles should be determined regularly in these patients. The combination of obesity, hypertension and diabetes is particularly hazardous to women who are taking this class of medication. To avoid this triad of conditions develop, the patient should be placed on an alternate form of therapy.
Discontinue medication at the earliest manifestation of: Thromboembolic and cardiovascular disorders such as: thrombophlebitis, pulmonary embolism, cerebrovascular disorders, myocardial ischemia, mesenteric thrombosis and retinal thrombosis. The use of estrogen/progestogen-combination products should be avoided in conditions which predispose to venous stasis and to vascular thrombosis, e.g. immobilization after accidents or confinement to bed during long-term illness. Under such conditions other nonhormonal methods of treatment should be considered. For use when surgery is contemplated, see Precautions.
+
+- Visual defects, partial or complete.
+- Papilledema, or ophthalmic vascular lesions.
+- Severe headache of unknown etiology, or worsening of pre-existing migraine headache.
+- Onset of jaundice or hepatitis.
+- Itching of the whole body.
+
+
Hypertension: Patients with essential hypertension whose blood pressure is wellcontrolled may be given the drug but only under close supervision. If a significant elevation of blood pressure in previously normotensive or hypertensive subjects occurs at any time during the administration of the drug, cessation of medication is necessary.
Migraine and Headache: The onset or exacerbation of migraine or the development of headache of a new pattern which is recurrent persistent or severe, requires discontinuation of medication and evaluation of the cause.
Diabetes: Diabetic patients, or those with a family history of diabetes, should be observed closely to detect any alterations in carbohydrate metabolism. Patients predisposed to diabetes who can be kept under close supervision may be given estrogen/progestogen combinations under strict medical supervision. Young diabetic patients whose disease is of recent origin, well-controlled, and not associated with hypertension or other signs of vascular disease such as ocular fundal changes should be closely observed.
",,"Symptoms and Treatment:There have been no reports of overdose with this tablet. There are no specific antidotes and treatment should be symptomatic, based on the knowledge of the pharmacological action of the constituents.
",,,"Store below 30°C and in dry place. Protect from light. Keep out of the reach of children.
",11
+1195,Cyclosporine (Ophthalmic),cyclosporine-ophthalmic-1195,https://medex.com.bd/attachments/vk1dE6BzT7qQSv4uIOtnYTLjgzDzJV/cyclosporine-ophthalmic-prescribing-information,Drugs for Dry eyes,Scleritis,"Cyclosporine Ophthalmic Emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with dry eye syndrome (keratoconjunctivitis sicca).
In addition to this, several clinical studies have showed that ... Read more
Cyclosporine Ophthalmic Emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with dry eye syndrome (keratoconjunctivitis sicca).
In addition to this, several clinical studies have showed that cyclosporine is effective in the management of different eye diseases like vernal keratoconjunctivitis, posterior blepharitis, non-infectious uveitis, superior limbic keratoconjunctivitis, phlyctenular keratoconjunctivitis and meibomian gland diseases.
","Drugs for Dry eyes
","Cyclosporine is an immunosuppressive agent when administered systemically. In patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, topical Cyclosporine is thought to act as a partial immunomodulator.
","One drop of Cyclosporine eye drop should be instilled twice a day in each eye approximately 12 hours apart. Cyclosporine eye drop can be used concomitantly with artificial tears, allowing a 15-minute interval between products.
",,,"Cyclosporine is contraindicated in patients with active ocular infections and in patients with known or suspected hypersensitivity to any of the ingredients in the formulation.
","The most common adverse event was ocular burning. Other events reported included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring).
","Pregnancy: There are no adequate and well-controlled studies of Cyclosporine Ophthalmic Emulsion in pregnant women. It should be administered to pregnant women if clearly needed.
Lactation: Cyclosporine is known to be excreted in human milk following systemic administration but excretion in human milk after topical treatment has not been investigated. Although blood concentrations are undetectable after topical administration of Cyclosporine eye drop, caution should be exercised when Cyclosporine is administered to a nursing woman.
","Cyclosporine eye drop should not be administered while wearing contact lenses. Patients with decreased tear production typically should not wear contact lenses. If contact lenses are worn, they should be removed prior to the administration of this formulation. Lenses may be reinserted 15 minutes following administration of Cyclosporine eye drop.
",,,,,,8
+1194,Cyclosporine,cyclosporine-1194,https://medex.com.bd/attachments/1t78isXUr6RJxmu4xbcO6wr81Xl2OD/cyclosporine-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Urticaria,"Transplantation indications: Solid organ transplantation, Bone marrow transplantation
Non-transplantation indications: Endogenous uveitis, Nephrotic syndrome, Rheumatoid arthritis, Psoriasis, Atopic dermatitis.
","Immunosuppressant, Vaccines, Anti-sera & Immunoglobulin
","Cyclosporine binds to cyclophilin. The complex then inhibits calcineurin which is normally responsible for activating transcription of interleukin 2. Cyclosporine also inhibits lymphokine production and interleukin release. In ophthalmic applications, the precise mechanism of action is not known. Cyclosporine emulsion is thought to act as a partial immunomodulator in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.
","Solid organ transplantation: Initially 10 to 15 mg/kg given in 2 divided doses starting 12 hours before surgery and to continue for 1 to 2 weeks post-operatively. Maintenance dose should be gradually reached to 2 to 6 mg/kg given in 2 divided doses.
+
Bone marrow transplantation: Initially 12.5 to 15 mg/kg given in 2 divided doses, starting on the day before transplantation. Maintenance treatment of 12.5 mg/Kg in 2 divided doses should be continued for at least 3 months (and preferably for 6 months) before the dose is gradually decreased to zero by 1 year after transplantation.
Endogenous uveitis: Initially 5 mg/kg per day orally given in 2 divided doses are recommended. For maintenance treatment, the dose should be slowly reduced to the lowest effective level.
Nephrotic syndrome: Initially 5 mg/kg for adults and 6 mg/kg for children given in 2 divided doses. In case of renal impairement, the initial dose should not exceed 2.5 mg/kg per day. For maintenance treatment, the dose should be slowly reduced to the lowest effective level.
Rheumatoid arthritis: For the first 6 weeks, the recommended dose is 3 mg/kg per day in 2 divided doses. To achieve full effectiveness, up to 12 weeks of Cyclosporine therapy may be required. For maintenance treatment, the dose has to be titrated individually according to tolerability.
Psoriasis & Atopic dermatitis: Initially 2.5 mg/kg per day orally given in 2 divided doses and 5 mg/kg per day for patients whose condition requires rapid improvement. For maintenance treatment, doses have to be titrated individually to the lowest effective level.
",,"Drugs that decrease Cyclosporine levels: Barbiturates, carbamazepine, oxcarbazepine, phenytoin, nafcillin, sulfadimidine i.v., rifampicin, octreotide, probucol, orlistat, hypericum perforatum, ticlopidine, sulfinpyrazone, terbinafine, bosentan.
Drugs that increase Cyclosporine levels: Macrolide antibiotics (e.g., erythromycin, azithromycin and clarithromycin), ketoconazole, fluconazole, itraconazole, voriconazole, diltiazem, nicardipine, verapamil, lercanidipine, metoclopramide, oral contraceptives, danazol, methylprednisolone (high dose), allopurinol, amiodarone, cholic acid and derivatives, protease inhibitors, imatinib, colchicine.
Other relevant drug interactions: Cyclosporine may reduce the clearance of digoxin, colchicine, prednisolone and HMG-CoA reductase inhibitors (statins).
","Hypersensitivity to Cyclosporine or to any of the excipients of Cyclosporine.
","Renal dysfunction; Hypertension; Tremor, headache, paraesthesia; Anorexia, nausea, vomiting, abdominal pain, diarrhoea, gingival hyperplasia and hepatic dysfunction; Hyperlipidaemia, hyperuricaemia, hyperkalaemia, hypomagnesaemia; Muscle cramps, myalgia and rarely muscle weakness, myopathy; Usually uncommon but anaemia, thrombocytopenia can occur; Hypertrichosis and allergic rashes.
","Pregnancy: There are no adequate and well-controlled studies in pregnant women and, therefore, Cyclosporine should not be used during pregnancy unless the potential benefit to the mother justifies the potential risk to the foetus.
Lactation: Cyclosporine passes into breast milk. Mothers receiving treatment with Cyclosporine should not breast-feed.
","Cyclosporine increases the risk of developing lymphomas and other malignancies, particularly those of the skin. So patients should be warned to avoid excess ultraviolet light exposure.
Cyclosporine may develop bacterial, fungal, parasitic and viral infections. So therapeutic strategies should be employed for long-term immunosuppressive therapy.
A reversible increase in serum creatinine and urea may occur during the first few weeks of Cyclosporine therapy and usually responding to dose reduction. In elderly patients, renal function should be monitored with particular care.
Regular monitoring of blood pressure is required during Cyclosporine therapy; if hypertension develops, appropriate antihypertensive treatment must be instituted.
Cyclosporine enhances the risk of hyperkalaemia, especially in patients with renal dysfunction. Caution is also required when Cyclosporine is co-administered with potassium sparing drugs. Cyclosporine enhances the clearance of magnesium. If considered necessary, magnesium supplementation should be given. Caution should be observed in treating patients with hyperuricaemia. During treatment with Cyclosporine, vaccination may be less effective; the use of live-attenuated vaccines should be avoided.
Non-transplant patients with impaired renal function, uncontrolled hypertension, uncontrolled infections, or any kind of malignancy should not receive Cyclosporine.
",,"Renal dysfunction, which resolve following drug withdrawal, may occur. Elimination can be achieved only by nonspecific measures, including gastric lavage, as Cyclosporine is not dialyzable to any great extent, nor is it cleared well by charcoal hemoperfusion.
",,,"Sporium oral solution should be used within 2 months of opening the bottle and be stored between 15 to 30° C, preferably not below 20° C for prolonged periods, as it contains oily components which tend to solidify at low temperatures. A jelly-like formation may occur below 20° C, which is reversible at temperatures up to 30° C. Slight sediment may still be observed which does not affect the efficacy and safety of the product.
",11
+1204,Cyclophosphamide,cyclophosphamide-1204,https://medex.com.bd/attachments/9YJpHChjADpHagfF6QjAgopQrcb8bE/cyclophosphamide-prescribing-information,Cytotoxic Chemotherapy,Vasculitis,"Malignant Diseases:
+Cyclophosphamide is indicated for the treatment of:
+
+- Malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma
... Read more
Malignant Diseases:
+Cyclophosphamide is indicated for the treatment of:
+
+- Malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma
+- Multiple myeloma
+- Leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenousand monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration)
+- Mycosis fungoides (advanced disease)
+- Neuroblastoma (disseminated disease)
+- Adenocarcinoma of the ovary
+- Retinoblastoma
+- Carcinoma of the breast
+
+Cyclophosphamide, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs.
+
Minimal Change Nephrotic Syndrome in Pediatric Patients:
+Cyclophosphamide is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatrics patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy.
","Cytotoxic Chemotherapy
","Cyclophosphamide is a prodrug which is converted in the body to the active metabolites. It acts at any stage of the cell cycle. It prevents cell division by cross-linking deoxyribonucleic acid (DNA) strands and reducing DNA synthesis. It also exerts a potent immunosuppressive effect.
","Intravenous (Adult)-
+Malignancies:
+
+- Low dose regimen: 2-6 mg/kg wkly as a single dose;
+- Moderate dose regimen: 10-15 mg/kg wkly as a single dose;
+- High dose regimen: 20-40 mg/kg as a single dose every 10-20 days.
+
+Alternatively,
+
+- 80-300 mg/m2 daily as a single dose, or
+- 300-600 mg/m2 wkly as a single dose, or
+- 600-1,500 mg/m2 as a single dose or
+- Short infusion at 10- to 20-day intervals.
+
+
Oral (Child)-
+Nephrotic syndrome:
+
+- 2 mg/kg daily for 8-12 wk.
+- Max cumulative dose: 168 mg/kg.
+- Max duration: 90 days.
+
+
Oral (Adult)-
+Malignancies:
+
+- Low dose regimen: 2-6 mg/kg wkly in divided dose.
+- Alternatively, 100-300 mg daily in divided doses, or
+- 50-250 mg/m2 daily or 80-300 mg/m2 daily in divided doses.
+
","Should be taken on an empty stomach. Preferably taken on an empty stomach, but may be taken with meals to minimise GI irritation. Ensure adequate fluid intake. Swallow whole.
","Increased risk of cardiotoxicity with doxorubicin or other cardiotoxic drugs. May increase incidence of mucositis with protease inhibitors. May increase haematotoxicity and/or immunosuppression with ACE inhibitors, natalizumab, paclitaxel, thiazide diuretics, zidovudine. May increase pulmonary toxicity with amiodarone. May increase nephrotoxicity with amphotericin B. May result to acute water intoxication with indometacin. May increase risk of hepatotoxicity with azathioprine. May increase incidence of hepatic veno-occlusive disease and mucositis with busulfan. May increase risk of haemorrhagic cystitis with previous or concomitant radiotherapy. May result to acute encephalopathy with metronidazole. May increase risk of thromboembolic complications. May alter the effect of warfarin. May increase immunosuppressive effect of ciclosporin. May result to prolonged apnoea with depolarising muscle relaxants (e.g. suxamethonium).
","Patient with bone marrow aplasia, urinary outflow obstruction, UTI, acute infection, drug- or radiation-induced urothelial toxicity. Pregnancy.
","Alopecia, skin and nails hyperpigmentation, nausea and vomiting, mucositis, inappropriate antidiuretic hormone secretion, carbohydrate metabolism disturbances, gonadal suppression, interstitial pulmonary fibrosis.
","Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Patient with DM, severe immunosuppression, acute porphyria, pre-existing CV disease or those at risk for cardiotoxicity. Renal and hepatic impairment. Lactation.
",,"Symptoms: Urotoxicity, myelosuppression, cardiotoxicity (including cardiac failure), stomatitis, veno-occlusive hepatic disease.
Management: Supportive treatment. May consider haemodialysis. Cystitis prophylaxis with mesna may be useful for urotoxicity.
",,"Reconstitute with 25 mL for a 500 mg vial, 50 mL for a 1,000 mg vial or 100 mL for a 2,000 mg vial to a concentration of 20 mg/mL using NaCl 0.9% for direct IV push, or NaCl 0.9% or sterile water for inj for IV infusion. Gently swirl to mix. For IV infusion, dilute further with dextrose 5% in water, NaCl 0.45% or dextrose 5% and NaCl 0.9% inj to a minimum concentration of 2 mg/mL.
","Store at or below 25°C.
",13
+1851,Cyclopentolate Hydrochloride,cyclopentolate-hydrochloride-1851,https://medex.com.bd/attachments/Tf8V6zyvr09mu64w9pQiD5ovsF6y2Z/cyclopentolate-hydrochloride-prescribing-information,Anticholinergics,Mydriasis,"Cyclopentolate is used mainly to produce mydriasis and cycloplegia for diagnostic purposes.
","Anticholinergics
","Cyclopentolate is an anticholinergic agent that induces relaxation of the sphincter of the iris and the ciliary muscles. When applied topically to the eyes, it causes a rapid, intense cycloplegic and mydriatic effect that is maximal in 15 to 60 minutes; recovery usually occurs within 24 hours. The cycloplegic and mydriatic effects are slower in onset and longer in duration in patients who have dark pigmented irises.
","To produce mydriasis and cycloplegia for diagnostic purposes, in adults and children over 1 year: 1 drop instilled in the eye(s), followed by a second drop 5 minutes later, if necessary. Drops should be administered 40 to 50 minutes prior to the procedure. To minimize systemic absorption, finger pressure should be applied to the lacrimal sac for 2 to 3 minutes following administration. Alternatively, the eyelids should be kept closed for 2 to 5 minutes following installation. Patients with heavily pigmented irises may require larger doses. Complete recovery from mydriasis and cycloplegia should occur within 24 hours.
Use in children: Infants and young children and children with blond hair or blue eyes may be especially sensitive to the effects of cyclopentolate, increasing the chance of side effects during treatment. Use of cyclopentolate in children has been associated with psychotic reactions and behavioral disturbances.
",,"Cyclopentolate may affect the action of concomitantly administered drugs such as: antihistamines, isoniazid, MAO inhibitors, phenothiazines, procainamide, disopyramide, propranolol, quinidine and tricyclic antidepressants. Anticholinergic agents, such as cyclopentolate, antagonize miosis and ciliary body contraction induced by cholinesterase inhibitors and cholinergic agonists.
","Cyclopentolate is contraindicated in patients with angle-closure glaucoma or in patients with shallow anterior chambers. Cyclopentolate should not be used in patients, especially children, who have previously experienced a severe systemic reaction to the drug, or in patients with hypersensitivity to any component of a cyclopentolate formulation.
","Blinding acute angle-closure glaucoma and raised intraocular pressure may occur during cyclopentolate therapy. The mydriasis may be reduced by the intraocular application of pilocarpine, physostigmine or isoflurophate. Transient burning sensation of the eye is more likely with the 0.5% solution. Systemic effects, resulting from excessive absorption from mucosal surfaces or from ingestion of the drug, may include xerostomia, flushing, tachycardia and urinary retention. More severe systemic effects are tachypnea, scarlatiniform rash, delirium, psychosis, fever, stupor, coma, respiratory failure and death.
",,"Cyclopentolate may cause increased intraocular pressure. Angle-closure glaucoma may be induced by cyclopentolate in patients with higher susceptibility to increased intraocular pressure including the elderly and individuals with shallow anterior chambers.
Cyclopentolate may cause an increase in intraocular pressure which if sustained, can potentially lead to irreversible loss of vision. The drug should be discontinued and the physician consulted immediately if eye pain, blurring of vision, rapid pulse or dizziness occurs. Patients may require the use of dark glasses following the application of cyclopentolate, due to photophobia associated with mydriasis. Patients should be advised to contact their physician if blurred vision and photophobia continue for more than 48 hours after discontinuing cyclopentolate. Systemic absorption of topical cyclopentolate from the nasal mucosal surfaces may result in systemic adverse effects. This is particularly the case in children, who are most susceptible to the drug's adverse effects. If signs of systemic toxicity appear, such as dry mouth, tachycardia or dizziness, the dosage schedule should be reduced or the drug discontinued.
",,,,,"Store in a cool and dry place, away from light. Keep out of reach of children.
",9
+312,Cyclobenzaprine Hydrochloride,cyclobenzaprine-hydrochloride-312,https://medex.com.bd/attachments/14D3wRMQBGCZDNE5XGOtqeDQ5tqnnX/cyclobenzaprine-hydrochloride-prescribing-information,Locally acting Skeletal Muscle Relaxants,Muscle spasm,"Cyclobenzaprine is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.
","Locally acting Skeletal Muscle Relaxants
","Cyclobenzaprine, a centrally-acting skeletal muscle relaxant, is structurally related to tricyclic antidepressants, thus they share similar properties. It acts on the brain stem, decreasing tonic-somatic motor activities influencing both the α and δ motor systems. It is used as an adjunct in the symptomatic treatment of painful muscle spasms associated with musculoskeletal conditions.
","Adult: 5 mg tid, may increase to 10 mg tid if needed. Treatment should not last more than 2-3 wk. Max: 60 mg.
Elderly: Initiate with 5 mg with less frequent dosing.
Pediatric: Safety and effectiveness of Cyclobenzaprine Hydrochloride in pediatric patients below 15 years of age have not been established.
",,"Plasma concentration may be increased with the use of cimetidine, diltiazem, disulfiram, methylphenidate, ritonavir, and verapamil. Side-effects are increased by adrenaline, amiodarone, general anesthetics, SSRIs, antihistamines, antimuscarinics, antipsychotics, anxiolytics and hypnotics, clozapine, disopyramide, diuretics, flecainide, MAOIs, moclobemide, moxifloxacin, nefopam, nicorandil, noradrenaline, phenothiazine, pimozide, procainamide, propafenone, quinidine, selegiline, sibutramine, sotalol, terfenadine, thioridazine, and tramadol. Effects of adrenergic neurone blockers, clonidine, barbiturates, nitrates, and primidone are reduced while effects of baclofen, opioid analgesics, and thyroid hormones are enhanced with concomitant use of cyclobenzaprine. Carbamazepine and rifampicin may increase metabolism of cyclobenzaprine. Effects may be antagonized by oestrogens. Avoid use with brimonidine, entacapone, artemether with lumefantrine, or sibutramine. CNS effects may be enhanced by other CNS depressants.
","Recent MI, arrhythmias, severe liver disease.
","The adverse reactions reported most frequently with Cyclobenzaprine Hydrochloride are drowsiness, dry mouth and dizziness. The incidence of these common adverse reactions is lower in the surveillance program than in the controlled clinical studies.
","Pregnancy category B. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Cyclobenzaprine Hydrochloride is administered to a nursing mother
","Because of its atropine-like action, Cyclobenzaprine Hydrochloride should be used with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic medication.
","Dose in hepatic impairment: Cyclobenzaprine should be used with caution in subjects with mild hepatic impairment starting with the 5 mg dose and titrating slowly upward. The use of Cyclobenzaprine in subjects with moderate to severe impairment is not recommended.
","Although rare, deaths may occur from over dosage with Cyclobenzaprine Hydrochloride. Signs and symptoms of toxicity may develop rapidly after Cyclobenzaprine overdose; therefore, hospital monitoring is required as soon as possible.
",,,,11
+2057,Cyclizine Hydrochloride,cyclizine-hydrochloride-2057,https://medex.com.bd/attachments/nGVRDZ5NS3HodfSKEmIgin6Rrh1zai/cyclizine-hydrochloride-prescribing-information,Anti-emetic drugs,Motion sickness,"Cyclizine Hydrochloride Tablets contain the active substance cyclizine hydrochloride, which belongs to a group of medicines called antihistamines which can be used to help stop you feeling sick (nausea) or being sick (vomiting).
Cyclizine Hydrochloride Tablets may be used by adults and children ... Read more
Cyclizine Hydrochloride Tablets contain the active substance cyclizine hydrochloride, which belongs to a group of medicines called antihistamines which can be used to help stop you feeling sick (nausea) or being sick (vomiting).
Cyclizine Hydrochloride Tablets may be used by adults and children aged 6 years and over. Cyclizine Hydrochloride Tablets may be used if you suffer from travel or motion sickness; nausea caused by cancer treatment (radiography) or other medicines; or if you have had an operation, as general anesthetics can sometimes cause sickness.
Cyclizine Hydrochloride Tablets can also be used to treat sickness caused by some inner ear problems such as Meniere’s disease.
","Anti-emetic drugs
",,"Adults: The recommended dose is one tablet up to three times daily.
Children over 12 years: The recommended dose is one tablet up to three times daily.
Children from 6 to 12 years: The recommended dose is half a tablet up to three times a day. The tablet can be divided into equal doses along the line scored on one side of the tablet.
Children under 6 years: Do not give this medicine to children under the age of 6. The tablets should be swallowed with a little water.
",,"Other medicines and Cyclizine Hydrochloride Tablets. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines especially the following: medicines for problems such as depression, anxiety or difficulty in sleeping; strong painkillers such as pethidine; any medicine which belong to a group of medicines called anticholinergics.
Cyclizine Hydrochloride Tablets with food and drink: Alcohol should be avoided when you are taking Cyclizine Hydrochloride Tablets.
","Do not take Cyclizine Hydrochloride Tablets:
+
+- if you are allergic to cyclizine hydrochloride or any of the other ingredients of this medicine (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing)
+- if you have been drinking alcohol. The anti-vomiting properties of cyclizine may increase the toxicity of alcohol.
+
","The following side effects are reported with a not known frequency (frequency cannot be estimated from the available data): skin rashes or itching, drowsiness, lack of coordination, headache, a dry mouth, nose or throat, blurred vision, involuntary rolling of the eyes, fast heartbeat, irregular heartbeat, difficulty in passing water, constipation, heartburn (reflux), feeling sick, being sick, diarrhea, stomach pain, loss of appetite, restlessness, nervousness, euphoria.
","If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
","Talk to your doctor, pharmacist or nurse before taking Cyclizine Hydrochloride Tablets if you:
+
+- suffer from an eye disease caused by a rise of pressure within the eye (glaucoma)
+- suffer from urinary retention (experience difficulty passing urine)
+- have an obstructive bowel condition
+- have any liver problems
+- suffer from phaeochromocytoma (tumour of the medulla of the adrenal glands)
+- suffer from high blood pressure
+- have epilepsy
+- are a man and you suffer from an enlarged prostate gland (difficulty or slowness passing urine)
+- have been told your heart is not working properly (heart failure)
+- suffer from an inherited disorder which can lead to a sensitivity to sunlight (porphyria).
+
",,"Symptoms of overdose include dry mouth, nose and throat, blurred vision, fast or irregular heartbeat, difficulty passing urine, drowsiness, dizziness, lack of balance and coordination, weakness, excitability, disorientation, impaired judgment, hallucinations, muscle spasm, involuntary movements, convulsions, high temperature and difficulty breathing. If you take more Cyclizine Hydrochloride Tablets than you should, contact your doctor or nearest hospital emergency department immediately. Remember to take this leaflet and/or the package with you to show the doctor what you have taken.
",,,"Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month. Store this medicine in a safe place below 25°C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
",10
+311,Cyanocobalamin,cyanocobalamin-311,https://medex.com.bd/attachments/nzlDSkT0Ru2QTkAZhiyHeLpmCaOPaY/cyanocobalamin-prescribing-information,Vitamin-B preparations,Vitamin B12 deficiency,"This preparation is indicated in Pernicious anemia,Vitamin B12 deficiency due to low intake from food,Thyrotoxicosis, Hemorrhage, Malignancy, Liver or kidney disease,Gastric bypass surgery, Total or partial gastrectomy, Gluten enteropathy or sprue, Folic acid deficiency, Macrocytic anaemia
","Vitamin-B preparations
","Vitamin B12 (cyanocobalamin) is required for the maintenance of normal erthropoiesis, nucleprotein and myelin synthesis, cell reproduction and normal growth; Coenzyme; metabolic functions include protein synthesis and carbohydrate metabolism. Plays role in cell replication and hematopoiesis.
","Usual Adult Dose for Pernicious Anemia
Initial dose: 1000 mcg intramuscularly or deep subcutaneous once a day for 6 to 7 days
If clinical improvement and reticulocyte response is seen from the above dosing:
+
+- 100 mcg every other day for 7 doses, then
+- 100 mcg every 3 to 4 days for 2 to 3 weeks, then
+- Maintenance dose: 100 to 1000 mcg monthly
+
+Administer concomitant folic acid if needed. Chronic treatment should be done with an oral preparation in patients with normal intestinal absorption.
Usual Adult Dose for B12 Nutritional Deficiency: 25 to 2000 mcg orally daily
Usual Adult Dose for Schilling Test: 1000 mcg intramuscularly is the flushing dose
Usual Pediatric Dose for B12 Nutritional Deficiency: 0.5 to 3 mcg daily
",,"Absorption reduced by antibiotics, aminosalicylic acid, anticonvulsants, biguanides, cholestyramine, cimetidine, colchicine, K salts, methyldopa.
","Leber's disease, tobacco amblyopia.
","Arthralgia (12%), Dizziness (12%), Headache (12%), Nasopharyngitis (12%), Anaphylaxis, Angioedema, Congestive heart failure, Peripheral vascular disease,Pulmonary edema, Diarrhea, Dyspepsia, Polycythemia vera, Sore throat, Nervousness, Rhinitis, Glossitis, Hypoesthesia
","Pregnancy Category A. Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
Lactation: Drug distributed in milk.
","Intensive treatment of B12-deficient megaloblastic anemia may cause hypokalemia and sudden death. Use with caution in patients with Leber optic nerve atrophy. Thrombocytosis may occur with treatment of severe vitamin B12 megaloblastic anemia
",,,,,,9
+306,Crotamiton,crotamiton-306,https://medex.com.bd/attachments/KXGxKagfG2CxOS8nLV0qSEcLvrlxZ1/crotamiton-prescribing-information,Parasiticidal preparations,Scabies,"Crotamiton lotion is indicated for the treatment of itching and skin irritation caused by, for example sunburn, dry eczema, itchy dermatitis, allergic rashes, hives, nettle rash, chickenpox, insect bites and stings, heat rashes and personal itching. Crotamiton lotion is also indicated for the treatment of pruritus after scabies
","Local Antipruritic, Parasiticidal preparations
","Crotamiton is an antiparasitic that is toxic to the scabies mite. Crotamiton also relieves itching by producing what is called a counter-irritation. As crotamiton evaporates from the skin, it produces a cooling effect. This cooling effect helps to divert your body's attention away from the itching.
","Pruritus: Adults (including the elderly) and children: Apply to the affected area 2-3 times daily. Crotamiton lotion will provide relief from irritation for 6-10 hours after each application. Crotamiton lotion can be used in children. There are no special dosage recommendations in the elderly.
Pruritus after scabies: Adults (including the elderly): After the patient has taken a warm bath, the skin should be well dried and Crotamiton lotion rubbed into the entire body surface (excluding the face and scalp) until no traces of the preparation remain visible on the surface. The application should be repeated once daily, preferably in the evening, for a total of 3-5 days. Depending on the response, special attention should be paid to sites that are particularly susceptibly to infestation by the mites (eg interdigital spaces, wrists, axillae and genitalia). Areas where there is pus formation should be covered with a dressing impregnated with Crotamiton lotion. While the treatment is in progress the patient may take a bath shortly before the next application. After completion of the treatment, a cleansing bath should be taken followed by a change of bed linen and underclothing.
Pruritus after scabies: Children: Application as described for adults but in children under 3 years of age Crotamiton lotion should not be applied more than once a day
",,,"Acute exudative dermatoses. Crotamiton 10% lotion is contra-indicated in patients with known hypersensitivity to crotamiton. Crotamiton 10% lotion should not be used in or around the eyes since contact with the eyelids may give rise to conjunctival inflammation.
","Occasionally irritation of the skin or contact allergy may occur. In such cases the preparation should be discontinued.
","Pregnancy Category C. There is no experience to judge the safety of Crotamiton lotion in pregnancy, therefore Crotamiton lotion is not recommended during pregnancy, especially in the first three months. It is not known whether the active substance passes into breast milk. Nursing mothers should avoid applying Crotamiton lotion in the area of the nipples.
","For external use only. Pregnancy.
","Children: Application as described for adults but in children under 3 years of age Cronix lotion should not be applied more than once a day.
","No information is available on overdosage following topical application. Oral ingestion of the drug may cause burning sensation of the mouth, irritation of the buccal, esophageal, and gastric mucosa, nausea, vomiting and abdominal pain. No known specific antidote. Empty stomach by emesis or gastric lavage followed by symptomatic treatment.
",,,"Store at 15-30° C.
",11
+1379,Crizotinib,crizotinib-1379,https://medex.com.bd/attachments/eJQbPeHihZvTUqF3EeKKI39NH5nIOR/crizotinib-prescribing-information,Targeted Cancer Therapy,Metastatic non-small cell lung cancer,"Crizotinib is a kinase inhibitor indicated for the treatment of patients with-
+
+- Metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive
+- Metastatic NSCLC whose tumors are ROS1-positive
+
","Targeted Cancer Therapy
","Crizotinib is an inhibitor of receptor tyrosine kinases including ALK, Hepatocyte Growth Factor Receptor (HGFR, c-Met), ROS1 (c-ros), and Recepteur d'Origine Nantais (RON). Translocations can affect the ALK gene resulting in the expression of oncogenic fusion proteins. The formation of ALK fusion proteins results in activation and dysregulation of the gene’s expression and signaling which can contribute to increased cell proliferation and survival in tumors expressing these proteins. Crizotinib demonstrated concentration-dependent inhibition of ALK, ROS1, and c-Met phosphorylation in cell-based assays using tumor cell lines and demonstrated antitumor activity in mice bearing tumor xenografts that expressed echinoderm microtubule-associated protein-like 4 (EML4)- or nucleophosmin (NPM)-ALK fusion proteins or c-Met.
","Recommended Dose: 250 mg orally, twice daily
Geriatric Use: No differences in safety or efficacy were observed between older and younger patients. Clinical studies of Crizotinib in patients with ROS1-positive metastatic NSCLC did not include sufficient numbers of patients age 65 years and older to determine whether they respond differently from younger patients
Pediatric Dose: The safety and effectiveness of Crizotinib in pediatric patients have not been established.
Renal impairment: 250 mg orally, once daily in patients with severe renal impairment (creatinine clearance <30 mL/min) not requiring dialysis. No starting dose adjustment is needed for patients with mild (ClCr 60-89 mL/min) or moderate (ClCr 30-59 mL/min) renal impairment based on a population pharmacokinetic analysis.
Hepatic Impairment: Caution should be used in patients with hepatic impairment
",,"CYP3A Inhibitors: Concurrent use of Crizotinib should be avoided with strong CYP3A inhibitors including but not limited to atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, and voriconazole
CYP3A Inducers: Concurrent use of Crizotinib should be avoided with strong CYP3A inducers including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John’s Wort
CYP3A Substrates: Concurrent use of Crizotinib should be avoided with CYP3A substrates with narrow therapeutic indices including but not limited to alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus
",,"The most common adverse reactions (≥25%) are vision disorders, nausea, diarrhea, vomiting, edema, constipation, elevated transaminases, fatigue, decreased appetite, upper respiratory infection, dizziness, and neuropathy.
","Based on its mechanism of action, Crizotinib can cause fetal harm when administered to a pregnant woman. There are no available data on the use of Crizotinib during pregnancy. Females of reproductive potential should be advised of the potential risk to a fetus and use of effective contraception.
There is no information regarding the presence of Crizotinib in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for adverse reactions in breastfed infants patients should not breastfeed during treatment with Crizotinib and for 45 days after the final dose.
","Hepatotoxicity: Patients should undergo periodic liver testing. Crizotinib should be temporarily suspended, dose reduced or permanently suspended
Interstitial lung disease (ILD)/ Pneumonitis: Drug should be permanently discontinued in patients with ILD/ Pneumonitis
QT interval prolongation: Electrocardiograms and electrolytes in patients who have a history of or predisposition for QTc prolongation, or who are taking medications that prolong QT should be monitored. Crizotinib should be temporarily suspended, dose reduced or permanently suspended
Bradycardia: Crizotinib can cause bradycardia. Heart rate and blood pressure should be regularly monitored. Crizotinib should be temporarily suspended, dose reduced or permanently suspended
Severe visual loss: Ophthalmological evaluation should be performed. Crizotinib should be discontinued in severe visual loss
Embryo-fetal toxicity: Crizotinib can cause fetal harm. Females of reproductive potential should be advised of the potential risk to a fetus and use of effective contraception
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+1803,Crisaborole,crisaborole-1803,https://medex.com.bd/attachments/gmfLkAXnZxij1JTE1ZaLFZdtorlJzK/crisaborole-prescribing-information,Topical anti-inflammatory preparations,Atopic dermatitis,"Crisaborole is indicated for topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months of age and older.
","Topical anti-inflammatory preparations
","The active ingredient, Crisaborole, is a phosphodiesterase-4 (PDE-4) inhibitor, mainly acting on phosphodiesterase 4B (PDE4B), which causes inflammation. Chemically, Crisaborole is a phenoxybenzoxaborole. It contains a boron atom that helps penetrate the skin and is essential for its binding activity. Inhibition of PDE4B appears to suppress the release of tumor necrosis factor alpha (TNFα), interleukin-12 (IL-12), IL-23 and other cytokines, proteins believed to be involved in the immune response and inflammation.
","Apply a thin layer of Crisaborole twice daily to affected areas. Crisaborole is for topical use only and not for ophthalmic, oral, or intravaginal use.
",,"In vitro studies using human liver microsomes indicated that under the conditions of clinical use, Crisaborole and metabolite 1 are not expected to inhibit cytochrome P450 (CYP) 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, and 3A4. In vitro human liver microsomes studies for metabolite 2 showed that it did not inhibit activities of CYP2C19, 2D6, and 3A4.
",,"Allergic reactions- Crisaborole may cause allergic reactions at or near the application site. These can be serious and may include hives, itching, swelling, and redness. The most common side effect of Crisaborole is application site pain, such as burning or stinging.
","Pregnancy: There is no available data with Crisaborole in pregnant women to inform the drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, there were no adverse developmental effects observed with oral administration of crisaborole in pregnant rats and rabbits during organogenesis at doses up to 3 and 2 times, respectively, the maximum recommended human dose (MRHD).
Lactation: There is no information available on the presence of crisaborole in human milk. Crisaborole is systemically absorbed. The lack of clinical data during lactation precludes a clear determination of the risk of crisaborole to a breastfed infant.
","Hypersensitivity reactions, including contact urticaria have occurred in patients treated with Crisaborole. If signs and symptoms of hypersensitivity occur, discontinue Crisaborole immediately and initiate appropriate therapy.
",,,,,"Do not store above 30°C temperature. Keep away from light and out of the reach of children.
",9
+1656,COVID Vaccine,covid-vaccine-1656,,"Vaccines, Anti-sera & Immunoglobulin",Increases immunity,"Increases immunity against Corona Virus.
","Vaccines, Anti-sera & Immunoglobulin
",,"The total number of these vaccine doses, if they are approved to be utilised in the course of time, should be enough to vaccine half of the country's over 1.3 billion population given the fact that most of the vaccine candidates against the coronavirus require two doses.
",,,,,,,,,,,,3
+1873,Copper Peptide + Procapil + Niacinamide + Biotin + L-Arginine,copper-peptide-procapil-niacinamide-biotin-l-arginine-1873,,Miscellaneous topical agents,Hair loss,"
+- Helps in substantial Hair growth.
+- It Prevents hair loss.
+- It delicays androgenic alopecia.
+- It Reduces premature greying of hair.
+- It Prevents split hair.
+- It Provides complete nourishment to the scalp and hair.
+
","Miscellaneous topical agents
","Procapil: Targets the root cause of hair loss. It strengthens hair and prevents hair loss naturally. Increases blood flow in the scalp which allows the hair to be well nourished, resulting in thickening of thin starving hair. Procapil activates a number of genes responsible for tissue repair mechanisms, thus provides protectingand repairing effects, keepinghair strongandhealthy.
Copper Peptide: Boosts the hair growth, health & appearance. Increases the proliferation of fibroblasts and keratinocytes; nerve outgrowth and hair follicle size, thus boosts the hair health andappearance.
","Take approximate quantity of Nemus Hair Serum in your palm and gently massage on the scalp till it absorbs. For best results apply before bed time.
",,,"Hypersensitivity to the active substance or to any of the excipients.
",,,,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",6
+329,Desloratadine,desloratadine-329,https://medex.com.bd/attachments/IyYRQw8j72OgHIuJNWDtIEG3Uysn6V/desloratadine-prescribing-information,Non-sedating antihistamines,Watery eye,"Desloratadine is indicated for the relief of symptoms associated with seasonal and perennial allergic rhinitis, such as sneezing, nasal discharge & itching, congestion or stuffiness, as well as ocular itching, tearing and redness, itching of palate and coughing. Desloratadine is also indicated for ... Read more
Desloratadine is indicated for the relief of symptoms associated with seasonal and perennial allergic rhinitis, such as sneezing, nasal discharge & itching, congestion or stuffiness, as well as ocular itching, tearing and redness, itching of palate and coughing. Desloratadine is also indicated for the relief of symptoms associated with chronic idiopathic urticaria such as the relief of itching and the size & number of hives.
","Non-sedating antihistamines
","Desloratadine, the major active metabolite of Loratadine, is a non-sedating; long acting tricyclic histamine antagonist with selective H1-receptor histamine antagonist activity. Desloratadine also inhibits histamine release from human mast cell.
","Pediatric drops:
+
+- Child 6-11 months of age: 2 ml drops once daily.
+- Child 1-2 years of age: 2.5 ml drops once daily.
+
+Syrup:
+
+- Child 6-11 months of age: 2 ml once daily.
+- Child 1-5 years of age: 2.5 ml once daily.
+- Child 6-11 years of age: 5 ml once daily.
+- Adults & >12 years of age: 10 ml once daily.
+
+Tablet:
+
+- Adults and children 12 years of age and over: 1 tablet daily
+
",,"No clinically relevant drug interactions have been reported.
","Desloratadine is contraindicated in patients having hypersensitivity to this medication or to any of its ingredients or Loratadine.
","Less common side effects may include headache, nausea, fatigue, dizziness, pharyngitis, dyspepsia and myalgia.
","Pregnancy Category C. The safe use of Desloratadine during pregnancy has not been established. Therefore, Desloratadine is not to be used during pregnancy unless clearly indicated. Desloratadine passes into breast milk, therefore a decision should be made whether to discontinue nursing or to discontinue Desloratadine taking into account the importance of the drug to the mother.
","In adult patients with liver or renal impairment: A starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. If the patient has medical or familial history of seizures.
","Recommended in the use in children & adolescents.
","No clinically relevant adverse effects have been reported.
",,,"Store in a cool & dry place, protected from light. Store below 30°C. Keep all medicines out of the reach of children.
",12
+1664,Dequalinium Chloride,dequalinium-chloride-1664,https://medex.com.bd/attachments/m0iNkuHhY9WYTGUWO4iGLlxq5bAVKT/dequalinium-chloride-prescribing-information,Other antibacterial preparation,Bacterial vaginosis,"Dequalinium chloride, the active ingredient in Fluomizin, belongs to the family of anti-infective and antiseptic drugs. Dequalinium chloride is active against the bacteria which cause bacterial vaginosis. Fluomizin is used for the treatment of bacterial vaginosis. It is inserted into the vagina for treatment at the site of infection.
","Other antibacterial preparation
",,"
+- Adult: The recommended dose is 1 vaginal tablet daily for 6 days.
+- Children and adolescents: There is insufficient experience of the use of Fluomizin in children and adolescents under 18 years of age.
+- Women above 55 years and elderly: There is insufficient experience of the use of Fluomizin in women above 55 years.
+
","
+- Use every evening before bed.
+- Wash your hands before opening the blister pack.
+- Lie down in a reclining position with the legs slightly bent. Insert one vaginal tablet deeply into the vagina.
+- You should stop the treatment during the heavy bleeding period of your menstruation and resume afterwards.
+- Do not stop treatment early, even if you no longer have any discomfort (e.g. itching, discharge, smell). A treatment of less than 6 days may result in your symptoms returning.
+- Dequalinium contains ingredients which do not dissolve completely, and the remains of the tablet are occasionally found in the underwear. This won’t affect the effectiveness of the treatment. The tablet will not stain your underwear but for your own comfort you can use a sanitary towel or panty liner.
+- If your vagina is dry, the vaginal tablet might not dissolve and be discharged as an intact tablet. As a consequence, the treatment is not optimal. In this case the vaginal tablet can be moistened with a drop of water before insertion.
+
",,"Do not use Dequalinium Chloride:
+
+- if you are allergic to the active substance dequalinium chloride or any of the other ingredients of this medicine.
+- if you have ulcers on your vagina or cervix.
+- if you have not yet had your first period.
+
","Sometimes the symptoms of vaginal infections (such as itching, burning and discharge) can get worse at the beginning of the treatment, before they start to get better. You should continue with the treatment, but if the complaints persist see your doctor for advice as soon as possible. Common side effects are Vaginal discharge; vaginal itching or vaginal burning; Vaginal yeast infection (thrush).
","If you are pregnant, think you may be pregnant or plan to have a baby ask your doctor or pharmacist for advice before using Dequalinium. Tell your doctor or pharmacist if you are breast-feeding or if you plan to breast-feed. Based on previous experience and since Dequalinium acts locally, no harmful effects on pregnancy and/or the unborn and breast fed infant are expected. Dequalinium should only be used during pregnancy and during breast-feeding if medically needed. Ask your doctor or pharmacist for advice before taking any medicine.
","
+- Intravaginal use of soaps, spermicides and vaginal douches (vaginal washes) is not recommended during treatment with Fluomizin.
+- As with all vaginal infections, unprotected sexual intercourse during treatment with Fluomizin is not recommended.
+- Fluomizin does not reduce the effectiveness of latex condoms.
+- This product may reduce the effectiveness of non-latex condoms or diaphragms. Consequently, you should use alternative methods of contraception for at least 12 hours following the treatment.
+- Do not use Fluomizin within 12 hours before birth to minimize exposure of the newborn to dequalinium chloride. Please inform your doctor otherwise.
+- You should stop the treatment during the heavy bleeding period of your menstruation and resume afterwards.
+- You should talk to your doctor if the symptoms persist at the end of the treatment or in case the symptoms return.
+
",,"
+- Using a higher daily dose or increasing the recommended duration might increase the risk of vaginal ulcerations. If you have accidentally used too many vaginal tablets, tell your doctor.
+- Do not use a double dose to make up for a forgotten tablet.
+- A treatment of less than 6 days may result in a relapse. Therefore, do not stop treatment early, even when you have no discomfort (e.g. itching, discharge, smell) anymore.
+
",,,"Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month.
",10
+327,Denosumab,denosumab-327,https://medex.com.bd/attachments/PEF5PWfCsXaBHlkPtGxqYLJZk9h7Wm/denosumab-prescribing-information,Inhibiting bone resorption,Prostate carcinoma,"Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or bone surgery) in patients with bone metastases from solid tumours.
","Inhibiting bone resorption
","Denosumab binds to Receptor activator of nuclear factor kappa-B ligand (RANKL), a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. Denosumab prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone.
","Subcutaneous Injection: 120 mg once every 4 wk into thigh, abdomen or upper arm. Ca & vitamin D supplements should be given whilst undergoing treatment.
",,"In subjects with postmenopausal osteoporosis, Denosumab (60 mg subcutaneous injection) did not affect the pharmacokinetics of midazolam, which is metabolized by cytochrome P450 3A4 (CYP3A4), indicating that it should not affect the pharmacokinetics of drugs metabolized by this enzyme in this population
","Hypersensitivity to denosumab or to any of the excipients.
","Dyspnoea, Hypocalcaemia, hypophosphataemia, Osteonecrosis of the Jaw (ONJ).
","Pregnancy Category D. There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Correct preexisting hypocalcaemia prior to therapy. Osteonecrosis of the jaw (ONJ). Perform oral & dental exam with preventive dentistry prior to treatment. Avoid invasive dental procedures & maintain good oral hygiene while on treatment. Atypical femoral fractures. Severe renal impairment (CrCl <30 ml/min) or in patients receiving dialysis. Concomitant use with other denosumab-containing prep. Pregnancy & lactation. Children.
",,"There is no experience with overdose in clinical studies. Denosumab has been administered in clinical studies using doses up to 180 mg every 4 weeks (cumulative doses up to 1,080 mg over 6 months), and no additional adverse reactions were observed.
",,,"Should be stored in cool and dry place.
",11
+1975,Delafloxacin,delafloxacin-1975,https://medex.com.bd/attachments/Njyqblxe01CBj52YBd59TkaYHXGN9d/delafloxacin-prescribing-information,4-Quinolone preparations,Skin and skin sructure infections,"Acute Bacterial Skin and Skin Structure Infections: Delafloxacin is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA] ... Read more
Acute Bacterial Skin and Skin Structure Infections: Delafloxacin is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, Enterococcus faecalis, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
Community-Acquired Bacterial Pneumonia: Delafloxacin is indicated in adults for the treatment of community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible [MSSA] isolates only), Klebsiella pneumoniae, Escherichia coli, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, Chlamydia pneumoniae, Legionella pneumophila, and Mycoplasma pneumoniae.
Usage: To reduce the development of drug-resistant bacteria and maintain the effectiveness of Delafloxacin and other antibacterial drugs, Delafloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
","4-Quinolone preparations
","Delafloxacin inhibits the activity of bacterial DNA topoisomerase IV and DNA gyrase (topoisomerase II). This interferes with bacterial DNA replication by preventing the relaxation of positive supercoils introduced as part of the elongation process. The resultant strain inhibits further elongation. Delafloxacin exerts concentration-dependent bacteriocidal activity.
The antibacterial activity of delafloxacin appears to best correlate with the ratio of area under the concentration-time curve of free delafloxacin to minimal inhibitory concentration (fAUC/MIC) for Gram-positive organisms such as Staphylococcus aureus and Gram-negative organisms such as Escherichia coli based on animal models of infection.
","Delafloxacin Tablets: Administer Delafloxacin at least 2 hours before or 6 hours after antacids containing magnesium, or aluminum, with sucralfate, with metal cations such as iron, or with multivitamin preparations containing zinc or iron, or with didanosine buffered tablets for oral suspension or the pediatric powder for oral solution. Delafloxacin Tablets can be taken with or without food. If patients miss a dose, they should take it as soon as possible anytime up to 8 hours prior to their next scheduled dose. If less than 8 hours remain before the next dose, wait until their next scheduled dose.
Delafloxacin Injection: Do NOT administer Delafloxacin for Injection with any solution containing multivalent cations, e.g., calcium and magnesium, through the same intravenous line. Do NOT co-infuse Delafloxacin for Injection with other medications.
Acute bacterial skin and skin structure infections: 300 mg of Delafloxacin for Injection every 12 hours over 60 minutes by intravenous infusion Or 300 mg of Delafloxacin for Injection every 12 hours over 60 minutes by intravenous infusion, then switch to a 450 mg Delafloxacin tablet orally every 12 hours at the discretion of the physician Or 450 mg Delafloxacin tablet orally every 12 hours for 5 to 14 days.
Community-Acquired Bacterial Pneumonia: 300 mg of Delafloxacin for Injection every 12 hours over 60 minutes by intravenous infusion Or 300 mg of Delafloxacin for Injection every 12 hours over 60 minutes by intravenous infusion, then switch to a 450 mg Delafloxacin tablet orally every 12 hours at the discretion of the physician Or 450 mg Delafloxacin tablet orally every 12 hours for 5 to 10 days.
",,"Fluoroquinolones form chelates with alkaline earth and transition metal cations. Oral administration of Delafloxacin with antacids containing aluminum or magnesium, with sucralfate, with metal cations such as iron, or with multivitamins containing iron or zinc, or with formulations containing divalent and trivalent cations such as didanosine buffered tablets for oral suspension or the pediatric powder for oral solution, may substantially interfere with the absorption of Delafloxacin, resulting in systemic concentrations considerably lower than desired. Therefore, Delafloxacin should be taken at least 2 hours before or 6 hours after these agents. There are no data concerning an interaction of intravenous Delafloxacin with oral antacids, sucralfate, multivitamins, didanosine, or metal cations. However, Delafloxacin should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line
","Delafloxacin is contraindicated in patients with known hypersensitivity to delafloxacin or any of the fluoroquinolone class of antibacterial drugs, or any of the components of Delafloxacin.
","Most common adverse reactions (incidence ≥2%) are nausea, diarrhea, headache, transaminase elevations, and vomiting.
","Pregnancy: The limited available data with Delafloxacin use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriages. When delafloxacin (as the N-methyl glucamine salt) was administered orally to rats during the period of organogenesis, no malformations or fetal death were observed at up to 7 times the estimated clinical exposure based on AUC. When rats were dosed intravenously in late pregnancy and through lactation, there were no adverse effects on offspring at exposures approximating the clinical intravenous (IV) exposure based on AUC.
Lactation: There are no data available on the presence of delafloxacin in human milk, the effects on the breast-fed infant, or the effects on milk production. Delafloxacin is excreted in the breast milk of rats. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Delafloxacin and any potential adverse effects on the breast-fed child from Delafloxacin or from the underlying maternal condition.
","Hypersensitivity Reactions: May occur after first or subsequent doses of Delafloxacin. Discontinue Delafloxacin at the first sign of a skin rash or any other sign of hypersensitivity. Clostridium difficile-associated diarrhea: Evaluate if diarrhea occurs.
","Pediatric Use: Use in patients under 18 years of age is not recommended. Safety and effectiveness in pediatric patients below the age of 18 years have not been established.
Geriatric use: Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone. This risk is further increased in patients receiving concomitant corticosteroid therapy.
Renal Impairment: Closely monitor serum creatinine levels in patients with severe renal impairment (eGFR 15 29 mL/min/1.73 m2 ) receiving intravenous delafloxacin. If serum creatinine level increases occur, consider changing to oral delafloxacin. Discontinue Delafloxacin if eGFR decreases to <15 mL/min/1.73 m2.
Hepatic Impairment: No dosage adjustment is necessary for Delafloxacin in patients with hepatic impairment
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+1970,Dehydroepiandrosterone,dehydroepiandrosterone-1970,,,,"Adequately powered, long-term clinical trials are lacking to support therapeutic use of dehydroepiandrosterone (DHEA) and dehydroepiandrosterone sulfate (DHEAS) supplementation (hereafter jointly referred to as DHEA/S). Reviews of clinical trials found no convincing evidence to support a place in therapy ... Read more
Adequately powered, long-term clinical trials are lacking to support therapeutic use of dehydroepiandrosterone (DHEA) and dehydroepiandrosterone sulfate (DHEAS) supplementation (hereafter jointly referred to as DHEA/S). Reviews of clinical trials found no convincing evidence to support a place in therapy for DHEA in improving cognitive function or physical strength in elderly patients, or in treating postmenopausal symptoms in women, hyperlipidemia or insulin resistance, schizophrenia, or cancer. Some evidence exists to support the use of DHEA/S supplementation in women with diminished ovarian reserves, in subpopulations of elderly women with osteoporosis, and in mild systemic lupus erythematosus. DHEA is recommended as third-line monotherapy or adjunctive therapy for treatment of major depressive disorder (MDD) by Canadian Network for Mood and Anxiety Treatments (CANMAT) clinical guidelines, and limited data suggest a potential role for DHEA as an anxiolytic.
",,"The sulfate derivative of DHEA has been shown to act as a noncompetitive antagonist of gamma-aminobutyric acid (GABA) receptors, as well as a positive allosteric modulator of N-methyl-D-aspartate receptors. In humans, neuroprotective, antioxidant, antihypertensive, and anti-inflammatory effects have also been reported. Serum DHEA levels peak in 60 to 480 minutes after administration.
","Adrenal insufficiency: 50 mg/day for 3 months is considered a replacement dose, while 200 mg/day achieves supraphysiological circulating levels and is considered a pharmacological dose.
Anorexia nervosa: 100 mg/day for 6 months was used in a pilot study.
Diminished ovarian reserve: 50 to 75 mg/day (in divided doses) has been used in clinical studies of assisted reproduction.
Exercise training–induced muscle damage: 100 mg/day of Dehydroepiandrosterone supplementation was administered over 5 days in a study in young men undergoing exercise training.
Major depressive disorder: Doses ranging from 30 to 450 mg/day for 6 to 8 weeks have been used in clinical studies.
Metabolic syndrome: 100 mg/day for 3 months has been used in a study evaluating effects against metabolic syndrome in pre-and postmenopausal women.
Postmenopausal women: 25 mg/day has been suggested because this dose minimizes androgenic adverse effects; however, only studies in which at least 50 mg/day was used demonstrated positive outcomes as hormonal replacement therapy.
",,"Supraphysiologic serum DHEAS levels due to DHEA supplementation have been documented to interfere with commercially available progesterone assays, yielding false-positive increases in serum progesterone.
","Use of Dehydroepiandrosterone is not recommended in breast or prostate cancer.
","Studies in adrenal insufficiency suggest DHEA is generally well tolerated. However, data from long-term studies are lacking. Observed adverse effects include mania and hypomania, acne, hirsutism, gynecomastia, testicular changes, increased blood pressure, and decreased high-density lipoprotein (HDL) levels.
Use caution in individuals with psychiatric disorders; agitation, confusion, anxiety, paranoia, and suicidal thoughts have been reported. Use of hormones like DHEA may cause erythrocytosis. Use caution in individuals with diabetes, as DHEA may increase insulin resistance or sensitivity. Use caution in individuals with liver dysfunction, as DHEA may exacerbate this condition. Use caution in individuals with polycystic ovarian syndrome, as DHEA may worsen this condition.
","Information regarding safety and efficacy in pregnancy and lactation is lacking. Dehydroepiandrosterone supplementation has been evaluated for use in improving oocyte production in infertility.
",,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",8
+1795,Degarelix Acetate,degarelix-acetate-1795,https://medex.com.bd/attachments/8e2F3caspTOyfdkBxRqJVtyeSvpbb5/degarelix-acetate-80-mg-injection-prescribing-information,Drugs affecting (inhibiting) gonadotrophin,Prostate carcinoma,"Degarelix Acetate is a gonadotrophin releasing hormone (GnRH) antagonist indicated for treatment of adult male patients with advanced hormone-dependent prostate cancer.
","Drugs affecting (inhibiting) gonadotrophin
","Degarelix is a selective gonadotrophin releasing-hormone (GnRH) antagonist that competitively and reversibly binds to the pituitary GnRH receptors, thereby rapidly reducing the release of the gonadotrophins, luteinizing hormone (LH) and follicle stimulating hormone (FSH), and thereby reducing the secretion of testosterone (T) by the testes. Prostatic carcinoma is known to be androgen sensitive and responds to treatment that removes the source of androgen. Unlike GnRH agonists, GnRH antagonists do not induce a LH surge with subsequent testosterone surge/tumour stimulation and potential symptomatic flare after the initiation of treatment.
A single dose of 240 mg degarelix, followed by a monthly maintenance dose of 80 mg, rapidly causes a decrease in the concentrations of LH, FSH and subsequently testosterone. The serum concentration of dihydrotestosterone (DHT) decreases in a similar manner to testosterone.
Degarelix is effective in achieving and maintaining testosterone suppression well below medical castration level of 0.5 ng/ml. Maintenance monthly dosing of 80 mg resulted in sustained testosterone suppression in 97% of patients for at least one year. No testosterone microsurges were observed after re-injection during degarelix treatment. Median testosterone levels after one year of treatment were 0.087 ng/ml (interquartile range 0.06-0.15) N=167.
","Starting dose: 240 mg administered as two consecutive subcutaneous injections of 120 mg each.
Maintenance dose (monthly administration): 80 mg administered as one subcutaneous injection.
The first maintenance dose should be given one month after the starting dose.
The therapeutic effect of degarelix should be monitored by clinical parameters and prostate specific antigen (PSA) serum levels. Clinical studies have shown that testosterone (T) suppression occurs immediately after administration of the starting dose with 96% of the patients having serum testosterone levels corresponding to medical castration (T≤0.5 ng/ml) after three days and 100% after one month. Long term treatment with the maintenance dose up to 1 year shows that 97% of the patients have sustained suppressed testosterone levels (T≤0.5 ng/ml).
In case the patient's clinical response appears to be sub-optimal, it should be confirmed that serum testosterone levels are remaining sufficiently suppressed.
Since degarelix does not induce a testosterone surge it is not necessary to add an anti androgen as surge protection at initiation of therapy.
","Degarelix must be reconstituted prior to administration. Degarelix is for subcutaneous use only, not to be administered intravenously. Intramuscular administration is not recommended as it has not been studied. Degarelix is administered as a subcutaneous injection in the abdominal region. The injection site should vary periodically. Injections should be given in areas where the patient will not be exposed to pressure e.g. not close to waistband or belt and not close to the ribs.
","No formal drug-drug interaction studies have been performed. Since androgen deprivation treatment may prolong the QTc interval, the concomitant use of degarelix with medicinal products known to prolong the QTc interval or medicinal products able to induce torsades de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics, etc. should be carefully evaluated. Degarelix is not a substrate for the human CYP450 system and has not been shown to induce or inhibit CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4/5 to any great extent in vitro. Therefore, clinically significant pharmacokinetic drug-drug interactions in metabolism related to these isoenzymes are unlikely.
","Hypersensitivity to the active substance or to any of the excipients of this preparation.
","The most commonly observed adverse reactions during degarelix therapy in the confirmatory phase III study (N=409) were due to the expected physiological effects of testosterone suppression, including hot flushes and weight increase (reported in 25% and 7%, respectively, of patients receiving treatment for one year), or injection site adverse reactions. Transient chills, fever or influenza like illness were reported to occur hours after dosing (in 3%, 2% and 1% of patients, respectively).
The injection site adverse reactions reported were mainly pain and erythema, reported in 28% and 17% of patients, respectively, less frequently reported were swelling (6%), induration (4%) and nodule (3%). These events occurred primarily with the starting dose whereas during maintenance therapy with the 80 mg dose, the incidence of these events pr 100 injections was: 3 for pain and <1 for erythema, swelling, nodule and induration. The reported events were mostly transient, of mild to moderate intensity and led to very few discontinuations (<1%). Serious injection site reactions were very rarely reported such as injection site infection, injection site abscess or injection site necrosis that could require surgical treatment/drainage.
","There is no relevant indication for use of Degarelix Acetate in women. Degarelix Acetate may inhibit male fertility as long as the testosterone is suppressed.
",,"Elderly, hepatically or renal impaired patients: There is no need to adjust the dose for the elderly or in patients with mild or moderate liver or kidney function impairment. Patients with severe liver or kidney impairment have not been studied and caution is therefore warranted.
Paediatric population: There is no relevant use of Degarelix Acetate in children and adolescents in the treatment of adult male patients with advanced hormone-dependent prostate cancer.
","There is no clinical experience with the effects of an acute overdose with degarelix. In the event of an overdose the patient should be monitored and appropriate supportive treatment should be given, if considered necessary.
",,,"This medicinal product does not require any special storage conditions. Chemical and physical in-use stability has been demonstrated for 2 hours at 25°C. From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
",12
+326,Deflazacort,deflazacort-326,https://medex.com.bd/attachments/IhoCgLM68fLSXPFOcxvyWZLD8525qf/deflazacort-prescribing-information,Glucocorticoids,Allergic and inflammatory disorders,"Deflazacort is indicated in-
+
+- Anaphylaxis, asthma, severe hypersensitivity reactions
+- Rheumatoid arthritis, juvenile chronic arthritis, polymyalgia rheumatica
+- Systemic lupus erythematosus, dermatomyositis, mixed connective tissue disease (other than systemic sclerosis), polyartritis nodosa, sarcoidosis
... Read more
Deflazacort is indicated in-
+
+- Anaphylaxis, asthma, severe hypersensitivity reactions
+- Rheumatoid arthritis, juvenile chronic arthritis, polymyalgia rheumatica
+- Systemic lupus erythematosus, dermatomyositis, mixed connective tissue disease (other than systemic sclerosis), polyartritis nodosa, sarcoidosis
+- Pemphigus,bullous pemphigoid, pyoderma gangrenosum
+- Minimal change nephrotic syndrome, acute interstitial nephritis
+- Rheumatic carditis
+- Ulcerative colitis, Crohn's disease
+- Uveitis, optic neuritis
+- Autoimmune haemolytic anaemia, idiopathic thrombocytopenic purpura
+- Acute and lymphatic leukaemia, malignant lymphoma, multiple myeloma
+- Immune suppression in transplantation
+
","Glucocorticoids
","Deflazacort provides anti-inflammatory action by inhibiting Phospholipase A2 enzyme which is responsible for prostaglandin synthesis. Besides Deflazacort decreases the release of certain chemicals that are important in the immune system. By decreasing the release of these chemicals Deflazacort provides immunosuppressive action.
","Adults-
+
+- For acute disorders: Up to 120 mg/day Deflazacort may need to be given initially. Maintenance doses in most conditions are within the range of 3-18 mg/day.
+- Rheumatoid arthritis: The maintenance dose is usually within the range of 3-18 mg/day. The smallest effective dose should be used and increased if necessary.
+- Bronchial asthma: In the treatment of an acute attack, high doses of 48-72 mg/day may be needed depending on severity and gradually reduced once the attack has been controlled. For maintenance in chronic asthma, doses should be titrated to the lowest dose that controls symptoms.
+- Other conditions: The dose of Deflazacort depends on clinical need titrated to the lowest effective dose for maintenance. Starting doses may be estimated on the basis of ratio of 5 mg prednisone or prednisolone to 6 mg.
+
+
Children: There has been limited exposure of children to Deflazacort in clinical trials. In children, the indications for glucocorticoids arethe same as for adults, but it is important that the lowest effective dosage is used. Alternate day administration may be appropriate. Doses of Deflazacort usually lie in the range 0.25-1.5 mg/kg/day.
The following ranges provide general guidance:
+
+- Juvenile chronic arthritis: The usual maintenance dose is between 0.25-1.0 mg/kg/day.
+- Nephrotic syndrome: Initial dose of usually 1.5 mg/kg/day followed by down titration according to clinical need.
+- Bronchial asthma: On the basis of the potency ratio, the initial dose should be between 0.25-1.0 mg/kg on alternate days.
+
+
Deflazacort withdrawal: In patients who have received more than physiological doses of systemic corticosteroids (approximately 9 mg per day or equivalent) for greater than 3 weeks, withdrawal should not be abrupt. How dose reduction should be carried out depends largely on whether the disease is likely to relapse as the dose of systemic corticosteroids is reduced.
",,"Deflazacort is metabolized in the liver. It is recommended to increase the maintenance dose of Deflazacort if drugs which are liver enzyme inducers are co-administered, e.g. rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone and aminoglutethimide. For drugs which inhibit liver enzymes, (e.g. ketoconazole) it may be possible to reduce the maintenance dose of Deflazacort.
","Hypersensitivity to or any of the ingredients. Patients receiving live virus immunization.
","GI disturbances, musculoskeletal, endocrine, neuropsychiatric, ophthalmic, fluid and electrolyte disturbances; susceptible to infection, impaired healing, hypersensitivity, skin atrophy, striae, telangiectasia, acne, myocardial rupture following recent Ml, thromboembolism.
","Pregnancy: Deflazacort does cross the placenta. However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intrauterine growth retardation. As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks.
Nursing Mother: Corticosteroids are excreted in breast milk, although no data are available for Deflazacort. Doses of up to 50 mg daily of Deflazacort are unlikely to cause systemic effects in the infant. Infants of mothers taking higher doses than this may have a degree of adrenal suppression but the benefits of breastfeeding are likely to outweigh any theoretical risk.
","The following clinical conditions require special caution and frequent patient monitoring is necessary-
+
+- Cardiac disease or congestive heart failure (except in the presence of active rheumatic carditis), hypertension, thromboembolic disorders. Glucocorticoids can cause salt and water retention and increased excretion of potassium. Dietary salt restriction and potassium supplementation may be necessary.
+- Gastritis or oesophagitis, diverticulitis, ulcerative colitis if there is the probability of impending perforation, abscess or pyogenic infections, fresh intestinal anastomosis, active or latent peptic ulcer.
+- Diabetes mellitus or family history, osteoporosis, myasthenia gravis, renal insufficiency.
+- Emotional instability or psychotic tendency, epilepsy.
+- Previous corticosteroid-induced myopathy.
+- Liver failure.
+- Hypothyroidism and cirrhosis, which may increase the glucocorticoid effect.
+- Ocular herpes simplex because of possible corneal perforation.
+
","Hepatic Impairment: In patients with hepatic impairment, blood levels of may be increased. Therefore the dose of Deflazacort should be carefully monitored and adjusted to the minimum effective dose.
Renal Impairment: In renally impaired patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary.
Elderly: In elderly patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary. The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age.
",,,,"Store in a cool (below 25°C) and dry place, protected from light & moisture. Keep out of the reach of children.
",11
+1465,Deferoxamine Mesylate,deferoxamine-mesylate-1465,https://medex.com.bd/attachments/ZMeV5EAviNQsxnsckKNuZNGaWzizxH/deferoxamine-mesylate-prescribing-information,Carboxylic acids and derivatives,Iron overload,"Deferoxamine Mesylate is indicated for:
+
+- Acute iron intoxication.
+- Chronic iron overload due to transfusion-dependent anemias.
+- Diagnosis of aluminum overload (deferoxamine mesylate) infusion test.
+- Chronic aluminum overload in patients with End-Stage Renal Failure (ESRF) under maintenance dialysis.
+
","Carboxylic acids and derivatives
","Deferoxamine works in treating iron toxicity by binding trivalent (ferric) iron (for which it has a strong affinity), forming ferrioxamine, a stable complex which is eliminated via the kidneys. 100 mg of deferoxamine is capable of binding approximately 8.5 mg of trivalent (ferric) iron. Deferoxamine works in treating aluminum toxicity by binding to tissue-bound aluminum to form aluminoxamine, a stable, water-soluble complex. The formation of aluminoxamine increases blood concentrations of aluminum, resulting in an increased concentration gradient between the blood and dialysate, boosting the removal of aluminum during dialysis. 100 mg of deferoxamine is capable of binding approximately 4.1 mg of aluminum.
","Deferoxamine mesylate should only be given parenterally. The dose should not exceed 6.0 grams in a twenty-four hour period. Although Deferoxamine can be given by intramuscular injection, in most cases it exerts a considerably greater effect when administered by continuous infusion either intravenously (especially in cases of acute iron intoxication) or subcutaneously (especially in patients with chronic iron overload).
Rapid intravenous injection of Deferoxamine exceeding 15 mg/kg/h has produced flushing of the skin, urticaria, hypotension and shock
",,"Concomitant use of Prochlorperazine: Concurrent treatment with Deferoxamine and prochlorperazine, a phenothiazine derivative, may lead to temporary impairment of consciousness.
Concomitant use of Vitamin C: Where an iron-overload is associated with ascorbic acid deficiency, oral administration of Vitamin C in the standard dosage (150 - 250 mg daily) may serve to enhance excretion of the iron complex in response to Deferoxamine. Larger doses of Vitamin C fail to produce an additional effect.
Concomitant use of Erythropoietin: There is evidence that aluminum intoxication causes reduced erythropoiesis. In dialysis patients with iron and/or aluminum overload receiving Deferoxamine and erythropoietin, it is important to adjust the dosage of the latter when necessary. Regular monitoring of iron stores should also be conducted.
","Patients who are hypersensitive to deferoxamine mesylate or component of the container, except where desensitization is successful.
",,"Pregnant Women: There are no adequate and well-controlled studies conducted in pregnant women.Studies in animals (rabbits) have shown reproductive toxicity. The risk to the fetus/mother is unknown. Women of childbearing potential with chronic iron and/or aluminum overload should not receive deferoxamine unless the use of an effective form of contraception, established before treatment, is continued throughout treatment and for at least the first month after treatment. During pregnancy, particularly in the first trimester, deferoxamine should only be used if the hazard of acute iron intoxication is considered to be greater than the potential teratogenic hazard of deferoxamine.
Nursing Women: It is not known whether deferoxamine mesylate passes into the breast milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse drug reactions in breast-fed newborns/infants, a decision should be made whether to abstain from breast-feeding or to abstain from using the medicinal product, taking into account the importance of the medicinal product to the mother.
","Therapy with Deferoxamine should be initiated and maintained by physician experienced in the treatment of chronic iron overload due to blood transfusions. It should be noted that some of the signs and symptoms reported as adverse effects may in fact be manifestations of the underlying disease (iron and/or aluminum overload). As with all medicines, Deferoxamine should be kept out of reach of children. Rapid intravenous injection of Deferoxamine exceeding 15 mg/kg/h has produced flushing of the skin, urticaria, hypotension and shock
Vitamin C supplements should not be given to patients with cardiac failure because impairment of cardiac function may be experienced in patients with severe chronic iron overload receiving combined treatment of Deferoxamine with high doses of vitamin C (more than 500 mg daily)
",,"Since Ddeferoxamine mesylate is available only for parenteral administration, acute intoxication is unlikely to occur.
",,,"Store between 15-25 °C. Do not store above 25°C.
",10
+325,Deferiprone,deferiprone-325,https://medex.com.bd/attachments/EuVOxcHhgwz8Pgx2dsQSSHjK7rZV5o/deferiprone-prescribing-information,Antidote preparations,,"Deferiprone is indicated for the treatment of iron overload patients with thalassemia major when deferoxamine therapy is contraindicated or inadequate. Deferiprone therapy should be initiated and maintained by a physician experienced in the treatment of patients with thalassemia.
","Antidote preparations
","Deferiprone is a chelating agent with an affinity for ferric ion (iron III). Deferiprone binds with ferric ions to form neutral 3:1 (deferiprone:iron) complexes that are stable over a wide range of pH values. Deferiprone has a lower binding affinity for other metals such as copper, aluminum and zinc than for iron.
","In adults and children over 6 years: this medicine may be given by mouth in doses of 25mg/kg three times daily. Doses above 100mg/kg daily are not recommended. Or, as directed by the registered physician.
",,"The safety of concurrent use of Deferiprone and Vitamin C has not been formally studied. Based on the reported adverse interaction that can occur between deferoxamine and Vitamin C, caution should be used when administering concurrent Deferiprone and Vitamin C. It should not be given with aluminium containing antacids.
","It is contraindicated for hypersensitivity to the active substance or any of the excipients.
","Gastrointestinal disorders such as diarrhoea, nausea, vomiting and abdominal pain are common during deferiprone treatment and may require temporary reduction in dose. A reddish brown discoloration of the urine is also common. Other adverse effects that have been reported include arthralgia and increased liver enzymes.
","Deferiprone is not recommended for use in pregnant & lactating women.
","Deferiprone has been shown to cause neutropenia including agranulocytosis. The patients neutrophil count should be monitored every week. Caution is advised in patients with hepatic or renal impairment.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+323,Deferasirox,deferasirox-323,https://medex.com.bd/attachments/zon2xkKzuKjqFZ42iBLUowsuFbaKRb/deferasirox-prescribing-information,Antidote preparations,Iron overload,"Deferasirox is indicated for the treatment of chronic iron overload due to blood transfusions in adult and paediatric patients (aged 2 years and over).
","Antidote preparations
","Deferasirox is an orally active chelator that is selective for iron (as Fe3+ ). It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio. Although deferasirox has very low affinity for zinc and copper there are variable decreases in the serum concentration of these trace metals after the administration of deferasirox. The clinical significance of these decreases is uncertain.
","2 years children & Adult Dose:
Chronic Iron overload: Initially, 20 mg/kg daily. Adjust dosage every 3-6 months as needed based on trends in serum ferritin concentrations (monitor monthly). Adjust dosage in increments of 5 or 10 mg/kg daily (up to maximum dosage of 30 mg/kg daily) according to the patient’s clinical response and therapeutic goals. Consider temporarily interrupting therapy if serum ferritin concentrations are consistently <500 mcg/L.
","Deferasirox must be taken once daily on an empty stomach at least 30 minutes before food, preferably at the same time each day. The tablets are dispersed by stirring in a glass of water or apple or orange juice (100 to 200 mL) until a line suspension is obtained. After the suspension has been swallowed, any residue must be resuspended in a small volume of water or juice and swallowed. The tablets must not be chewed or swallowed whole. Dispersion in carbonated drinks or milk is not recommended due to foaming and slow dispersion, respectively.
","May chelate Al when used with Al-containing antacids. Decreased exposure with colestyramine and potent inducers of UGT enzymes (e.g. carbamazepine, rifampicin, phenytoin). May increase serum concentration of CYP1A2 (e.g. duloxetine, theophylline) and CYP2C8 (e.g. repaglinide, paclitaxel) substrates, and decrease serum concentrations of CYP3A4 substrates (e.g. ciclosporin, hormonal contraceptives, simvastatin).
","Creatinine clearance <40 mL/min or serum creatinine >2 times the age-appropriate upper limit of normal. High risk myelodysplastic syndrome (MDS) patients and patients with other hematological and non-hematological malignancies who are not expected to benefit from chelation therapy due to the rapid progression of their disease. Hypersensitivity to the active substance or to any of the excipients.
","Serum creatinine increase, Abdominal pain, Nausea, Vomiting, Diarrhea, Proteinuria, Pyrexia, Headache, Cough , Nasopharyngitis, Pharyngolaryngeal pain, Influenza, Rash, Respiratory tract infection, Bronchitis, ALT increased, Arthralgia, back pain, Acute tonsillitis, Rhinitis, Fatigue, Ear infection, Transaminitis, Urticaria, Anaphylaxis, Angioedema, Cytopenias, including agranulocytosis, neutropenia and thrombocytopenia; leukocytoclastic vasculitis
","Pregnancy: No clinical data on exposed pregnancies are available for deferasirox. Studies in animals have shown some reproductive toxicity at maternally toxic doses. The potential risk for humans is unknown. As a precaution, it is recommended that Deferasirox not be used during pregnancy unless clearly necessary.
Breast-feeding: In animal studies, Deferasirox was found to be rapidly and extensively secreted into maternal milk. No effect on the offspring was noted. It is not known if Deferasirox is secreted into human milk. Breast-feeding while taking Deferasirox is not recommended.
","Moderate hepatic impairment. Children. Pregnancy and lactation.
","Dosage Modification for Adverse Renal Effects: Interrupt therapy if a progressive increase in SCR (Serum Creatinine Concentration) beyond the ULN occurs. Once SCR returns to within normal limits, reinitiate therapy at a lower dosage followed by gradual dosage escalation if clinical beneht is expected to outweigh potential risks. Reduce dosage by 10 mg/kg daily if SCR at 2 consecutive visits increases to a level >33% above the average pretreatment value and the increase cannot be attributed to other causes.
Dosage Modifcation for Adverse Hepatic Effects: Consider dosage adjustment or interruption of therapy in patients with severe, persistent, progressive, or unexplained elevations of liver function test results.
","Single doses up to 40 mg/kg in normal subjects have been well tolerated. Acute signs of overdose may include nausea, vomiting, headache, and diarrhea. Overdose may be treated by induction of emesis or by gastric lavage, and by symptomatic treatment.
",,"Completely disperse tab by stirring in water, orange or apple juice. Disperse 1 gm in 210 ml of liq. Following admin, any residue should be resuspended in a small vol of liq.
","Store at 25° C. Protect from moisture.
",14
+1230,Daunorubicin,daunorubicin-1230,https://medex.com.bd/attachments/3UspGcOMf39x3MQkVn5cl2ppafSZBC/daunorubicin-prescribing-information,Cytotoxic Chemotherapy,Leukemia,"Daunorubicin in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.
","Cytotoxic Chemotherapy
","Daunorubicin has antimitotic and cytotoxic activity through a number of proposed mechanisms of action. It forms complexes with DNA by intercalation between base pairs. It inhibits topoisomerase II activity by stabilizing the DNA- topoisomerase II complex, preventing the religation portion of the ligation- religation reaction that topoisomerase II catalyzes. Single strand and double-strand DNA breaks result. It may also inhibit polymerase activity, affect the regulation of gene expression, and produce free radical damage to DNA. It possesses an antitumor effect against a wide spectrum of animal tumors, either grafted or spontaneous.
Distribution: Daunorubicin is rapidly and widely distributed in tissues, with the highest levels in the spleen, kidneys, liver, lungs and heart. The drug binds to many cellular components, particularly nucleic acids. There is no evidence that it crosses the blood-brain barrier, but the drug apparently crosses the placenta.
Metabolism and Elimination: Daunorubicin is extensively metabolized in the liver and other tissues, mainly by cytoplasmic aldo-keto reductases, producing daunorubicinol, the major metabolite which has antineoplastic activity. Approximately 40% of the drug in the plasma is present as daunorubicinol within 30 minutes and 60% in 4 hours after a dose of Daunorubicin. Further metabolism via reduction cleavage of the glycosidic bond, 4-O demethylation, and conjugation with both sulfate and glucuronide have been demonstrated. Simple glycosidic cleavage of Daunorubicin or Daunorubicinol is not a significant metabolic pathway in man. Twenty-five percent of an administered dose of Daunorubicin is eliminated in an active form by urinary excretion and an estimated 40% by biliary excretion.
","Parenteral drug products should be inspected visually for particulate matter prior to administration.
Representative Dose Schedules and Combination for the Approved Indication of Remission Induction in Adult Acute Nonlymphocytic Leukemia: In Combination: For patients under age 60, Daunorubicin 45 mg/m2/day IV on days 1, 2, and 3 of the first course and on days 1, 2 of subsequent courses AND cytosine arabinoside 100 mg/m2/day IV infusion daily for 7 days for the first course and for 5 days for subsequent courses. For patients 60 years of age and above, Daunorubicin 30 mg/m2/day IV on days 1, 2, and 3 of the first course and on days 1, 2 of subsequent courses AND cytosine arabinoside 100 mg/m2/day IV infusion daily for 7 days for the first course and for 5 days for subsequent courses. This Daunorubicin dose-reduction is based on a single study and may not be appropriate if optimal supportive care is available.
Representative Dose Schedule and Combination for the Approved Indication of Remission Induction in Pediatric Acute Lymphocytic Leukemia: In Combination: Daunorubicin 25 mg/m2 IV on day 1 every week, Vincristine 1.5 mg/m2 IV on day 1 every week, prednisone 40 mg/m2 PO daily. Generally, a complete remission will be obtained within four such courses of therapy; however, if after four courses the patient is in partial remission, an additional one or, if necessary, two courses may be given in an effort to obtain a complete remission. In children less than 2 years of age or below 0.5 m2 body surface area, it has been recommended that the Daunorubicin dosage calculation should be based on weight (1 mg/kg) instead of body surface area.
Representative Dose Schedules and Combination for the Approved Indication of Remission Induction in Adult Acute Lymphocytic Leukemia: In Combination: Daunorubicin 45 mg/m2/day IV on days 1, 2, and 3 and Vincristine 2 mg IV on days 1, 8, and 15; prednisone 40 mg/m2/day PO on days 1 through 22, then tapered between days 22 to 29; L-asparaginase 500 IU/kg/day x 10 days IV on days 22 through 32. Or, as directed by the registered physicians.
",,"The use of Daunorubicin in a patient who has previously received Doxorubicin increases the risk of cardiotoxicity. Daunorubicin should not be used in patients who have previously received the recommended maximum cumulative doses of Doxorubicin or Daunorubicin. Cyclophosphamide used concurrently with Daunorubicin may also result in increased cardiotoxicity. Dosage reduction of Daunorubicin may be required when used concurrently with other myelosuppressive agents. Hepatotoxic medications, such as high-dose Methotrexate, may impair liver function and increase the risk of toxicity.
","It is contraindicated in patients with known hypersensitivity to Daunorubicin or any other components of this product.
","Dose-limiting toxicity includes myelosuppression and cardiotoxicity. Other reactions include:
+
+- Cutaneous: Reversible alopecia occurs in most patients. Rash, contact dermatitis and urticaria have occurred rarely.
+- Gastrointestinal: Acute nausea and vomiting occur but are usually mild. Antiemetic therapy may be of some help. Mucositis may occur 3 to 7 days after administration. Diarrhea and abdominal pain have occasionally been reported.
+- Local: If extravasation occurs during administration, severe local tissue necrosis, severe cellulitis, thrombophlebitis or painful induration can result.
+- Acute Reactions: Rarely, anaphylactoid reaction, fever, and chills can occur. Hyperuricemia may occur, especially in patients with leukemia, and serum uric acid levels should be monitored.
+
","Pregnancy Category D. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Daunorubicin, mothers should be advised to discontinue nursing during Daunorubicin therapy.
","Therapy with Daunorubicin requires close patient observation and frequent complete blood-count determinations. Cardiac, renal, and hepatic function should be evaluated prior to each course of treatment. Appropriate measures must be taken to control any systemic infection before beginning therapy with Daunorubicin. It may transiently impart a red coloration to the urine after administration, and patients should be advised to expect this.
Daunorubicin Hydrochloride Injection must be given into a rapidly flowing intravenous infusion. It must never be given by the intramuscular or subcutaneous route. Severe local tissue necrosis will occur if there is extravasation during administration.
Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure may occur either during therapy or months to years after termination of therapy. The incidence of myocardial toxicity increases after a total cumulative dose exceeding 400 to 550 mg/m2 in adults, 300 mg/m2 in children more than 2 years of age, or 10 mg/kg in children less than 2 years of age.
Severe myelosuppression occurs when used in therapeutic doses; this may lead to infection or hemorrhage.
It is recommended that Daunorubicin Hydrochloride be administered only by physicians who are experienced in leukemia chemotherapy and in facilities with laboratory and supportive resources adequate to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The physician and institution must be capable of responding rapidly and completely to severe hemorrhagic conditions and/or overwhelming infection.
Dosage should be reduced in patients with impaired hepatic or renal function.
",,,,"The sterile vial contents provide 20 mg of Daunorubicin, with 5 mg of Daunorubicin per ml. The desired dose is withdrawn into a syringe containing 10 ml to 15 ml of 0.9% sodium chloride injection, USP and then injected into the tubing or sidearm in a rapidly flowing IV infusion of 5% Dextrose injection, USP or 0.9% Sodium Chloride Injection, USP. Daunorubicin Hydrochloride should not be administered mixed with other drugs or heparin.
","Store unopened vials in the refrigerator, 2°-8°C. Contains no preservatives. Discard unused portions. Protect from light. If Daunorubicin contacts the skin or mucosae, the area should be washed thoroughly with soap and water. Procedures for proper handling and disposal of anticancer drugs should be considered.
",11
+1292,Dasatinib,dasatinib-1292,https://medex.com.bd/attachments/sAm9z57hAuMuFvVk3JcRf4yroAmSrx/dasatinib-prescribing-information,Targeted Cancer Therapy,Chronic myeloid leukaemia,"Dasatinib is indicated for the treatment of adults with:
+
+- Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
+- Chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.
... Read more
Dasatinib is indicated for the treatment of adults with:
+
+- Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
+- Chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.
+- Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
+
","Targeted Cancer Therapy
","Dasatinib, at nanomolar concentrations, inhibits the following kinases: BCR-ABL, SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFRβ. Based on modeling studies, dasatinib is predicted to bind to multiple conformations of the ABL kinase. In vitro, dasatinib was active in leukemic cell lines representing variants of imatinib mesylate sensitive and resistant disease. Dasatinib inhibited the growth of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) cell lines overexpressing BCR-ABL. Under the conditions of the assays, dasatinib was able to overcome imatinib resistance resulting from BCR-ABL kinase domain mutations, activation of alternate signaling pathways involving the SRC family kinases (LYN, HCK), and multi-drug resistance gene overexpression.
","The recommended starting dosage of Dasatinib for:
+
+- Chronic phase CML is 100 mg administered orally once daily.
+- Accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL is 140 mg administered orally once daily.
+
+Tablets should not be crushed or cut; they should be swallowed whole. Dasatinib can be taken with or without a meal, either in the morning or in the evening.
In clinical studies, treatment with Dasatinib was continued until disease progression or until no longer tolerated by the patient. The effect of stopping treatment on long-term disease outcome after the achievement of a cytogenetic response (including complete cytogenetic response [CCyR]) or major molecular response (MMR) is not known.
",,"Concomitant use with drugs that have narrow therapeutic index (e.g. alfentanil, cisapride, ciclosporin, fentanyl, pimozide, quinidine, simvastatin, sirolimus, tacrolimus, ergot alkaloids) as it may increase the serum levels of these drugs. Increased risk of bleeding and thrombocytopenia with antiplatelet drugs, anticoagulants, and NSAIDs.
","Concomitant use with CYP3A4 inhibitors (e.g. atazanavir, clarithromycin, erythromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole or grapefruit juice); CYP3A4 inducers (e.g. carbamazepine, dexamethasone, phenytoin, phenobarbital, rifampicin or St John's wort); antacid. Pregnancy.
","Reversible myelosuppression, neutropenia, anaemia, thrombocytopenia, fluid retention, pulmonary arterial HTN, QT prolongation, cardiac failure, arrhythmias, HTN, musculoskeletal pain, GI disturbances, headache, chills, fatigue, asthenia, myalgia, chest pain, arthralgia, pyrexia, mucositis, flushing, colitis, electrolyte disturbances, appetite and wt disturbances, rash, dermatitis, hyperhidrosis, pruritus, acne.
","Pregnancy category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Patients with predisposing factors for QT prolongation (e.g. congenital long QT syndrome, hypokalaemia, hypomagnesaemia, on antiarrhythmic therapy, or receiving cumulative high doses of anthracyclines). Hepatic impairment. Lactation.
","Pediatric Use: The safety and efficacy of Dasatinib in patients less than 18 years of age have not been established.
Geriatric Use: No differences in confirmed Complete Cytogenetic Response (cCCyR) and MMR were observed between older and younger patients. Of the 2712 patients in clinical studies of Dasatinib, 617 (23%) were 65 years of age and older, and 123 (5%) were 75 years of age and older. While the safety profile of Dasatinib in the geriatric population was similar to that in the younger population, patients aged 65 years and older are more likely to experience the commonly reported adverse reactions of fatigue, pleural effusion, diarrhea, dyspnea, cough, lower gastrointestinal hemorrhage, and appetite disturbance, and more likely to experience the less frequently reported adverse reactions of abdominal distention, dizziness, pericardial effusion, congestive heart failure, hypertension, pulmonary edema, and weight decrease, and should be monitored closely.
Hepatic Impairment: No dosage adjustment is necessary in patients with hepatic impairment. Caution is recommended when administering Dasatinib to patients with hepatic impairment.
Renal Impairment: There are currently no clinical studies with Dasatinib in patients with impaired renal function. Less than 4% of dasatinib and its metabolites are excreted via the kidney.
","Symptoms: Significant platelet count reduction. Management: Closely monitor for myelosuppression. Supportive and symptomatic treatment.
",,,"Dasatinib tablets should be stored at 20°C to 25°C
",12
+322,Darifenacin,darifenacin-322,https://medex.com.bd/attachments/DYTV0loB5FfD5I2fhguHv8983gZYfY/darifenacin-prescribing-information,BPH/ Urinary retention/ Urinary incontinence,Urinary frequency and urgency,"Darifenacin is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.
","BPH/ Urinary retention/ Urinary incontinence
","Darifenacin is a potent, competitive and selective muscarinic receptor antagonist which has greater binding affinity for muscarinic M3 receptors. M3 receptors are involved in the contraction of the detrusor muscle of the bladder, GI smooth muscle, saliva production, and iris sphincter function. Darifenacin may increase volume threshold in patients with involuntary detrusor contraction, thus increase bladder capacity.
","Darifenacin 7.5 mg once daily; may increase dose to 15 mg once daily if no adequate response after 2 wk of therapy. Darifenacin should be taken with liquid. It can be taken with or without food, and should be swallowed whole and not chewed, divided or crushed.
For patients with moderate hepatic impairment or when co-administered with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and nefazadone), the daily dose of Darifenacin should not exceed 7.5 mg.
",,"Darifenacin has known drug-drug interaction with CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, nelfinavir etc.). The concomitant use of Darifenacin with other anticholinergic agents may increase the frequency and/or severity of dry mouth, constipation, blurred vision and other anticholinergic pharmacological effects.
","Patient with urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, and in patients who are at risk for these conditions.
","The most common side effects are dry mouth & constipation. Other less commonly reported side effects include- abnormal vision, back pain, dry skin, hypertension, vomiting, peripheral edema, weight gain, arthralgia, bronchitis, pharyngitis, rhinitis, sinusitis, rash, pruritus, urinary tract disorder and vaginitis.
","Pregnancy Category C. Darifenacin should be used during pregnancy only if the benefit to the mother outweighs the potential risk to the fetus.
Lactation: It is not known whether Darifenacin is excreted into human milk and therefore caution should be exercised before Darifenacin is administered to a nursing woman.
","Darifenacin should be used with caution in the patient at risk for urinary retention & decreased gastrointestinal motility, with impaired renal & hepatic impairment.
",,"Overdosage with antimuscarinic agents can result in severe antimuscarinic effects. ECG monitoring is recommended when event of overdosage is occurred. Darifenacin has been administered in clinical trials at doses up to 75 mg (five times the maximum therapeutic dose) and signs of overdose were limited to abnormal vision.
",,,"Store at 25° C. Protect from light.
",11
+1376,Darbepoetin Alfa,darbepoetin-alfa-1376,https://medex.com.bd/attachments/zAItmCFBIO8xnE1JAo4mz7vkJqFyw5/darbepoetin-alfa-prescribing-information,Haematopoietic Agents,Anaemia,"Anemia Due To Chronic Kidney Disease: Darbepoetin Alfa is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.
Anemia Due To Chemotherapy In Patients With Cancer: ... Read more
Anemia Due To Chronic Kidney Disease: Darbepoetin Alfa is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.
Anemia Due To Chemotherapy In Patients With Cancer: Darbepoetin Alfa is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
","Haematopoietic Agents
","Darbepoetin alfa stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. Erythropoietin interacts with progenitor stem cells to increase red cell production. Binding of erythropoietin to the erythropoietin receptor leads to receptor dimerization, which facilitates activation of JAK-STAT signaling pathways within the cytosol. Activated STAT (signal transducers and activators of transcription) proteins are then translocated to the nucleus where they serve as transcription factors which regulate the activation of specific genes involved in cell division or differentiation.
","Usual Adult Dose for Anemia Associated with Chronic Renal Failure:
+Chronic Kidney Disease (CKD) Patients Not on Dialysis:
+
+- Initial dose: 0.45 mcg/kg IV or subcutaneously once every 4 weeks as appropriate
+- Comments: Initiate treatment only when hemoglobin is less than 10 g/dL, rate of hemoglobin decline indicates likelihood of requiring RBC transfusion, and reducing risk of alloimmunization and/or other RBC transfusion-related risks is a goal.
+
+CKD Patients on Dialysis:
+
+- Initial dose: 0.45 mcg/kg IV or subcutaneously once a week or 0.75 mcg/kg once every 2 weeks as appropriate
+- Comments: Initiate treatment when hemoglobin is less than 10 g/dL. IV route is recommended for patients on hemodialysis.
+
+
+
Usual Adult Dose for Anemia Associated with Chemotherapy:
+
+- Initial dose: 2.25 mcg/kg subcutaneously once a week or 500 mcg subcutaneously once every 3 weeks
+- Duration of therapy: Until completion of chemotherapy course
+- Comments: Initiate treatment if hemoglobin is less than 10 g/dL and a minimum of 2 additional months of chemotherapy is planned. Use the lowest dose necessary to avoid RBC transfusions.
+- Use: Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy.
+
",,"Antagonism of hypotensive effect and increased risk of hyperkalemia with ACE inhibitors and angiotensin II receptor antagonists. Ethanol.
","Darbepoetin is contraindicated in patients with:
+
+- Uncontrolled hypertension
+- Pure red cell aplasia (PRCA) that begins after treatment with Darbepoetin or other erythropoietin protein drugs
+- Serious allergic reactions to Darbepoetin
+
","Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism; Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with cancer; Hypertension; Seizures; Serious allergic reaction; Severe Cutaneous Reactions
","Pregnancy Category C. It is not known whether Darbepoetin Alfa is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Darbepoetin Alfa is administered to a nursing woman.
","Pregnancy and lactation, children. Hypertension; history of seizures; hepatic impairment; sickle cell anaemia; sudden stabing migraine-like pain (warning sign of hypotensive crisis); exclude other causes of anaemia; ischaemic vascular disease; thrombocytosis; epilepsy; malignant disease; increase in heparin dose may be needed; increased risk of thrombosis when used for anaemia before orthopedic surgery; CV disease including recent MI/cerebrovascular accident. Monitor haemoglobin, BP and electrolytes; platelet count for 1st 8 wk.
","Pediatric Use:
+
+- Pediatric Patients With CKD: Darbepoetin safety and efficacy were similar between adults and pediatric patients with CKD when Darbepoetin was used for initial treatment of anemia or patients were transitioned from treatment with epoetin alfa to Darbepoetin
+- Pediatric Patients With Cancer: The safety and efficacy of Darbepoetin in pediatric patients with cancer have not been established.
+
+
Geriatric Use: Of the 1801 patients with CKD in clinical studies of Darbepoetin, 44% were age 65 and over, while 17% were age 75 and over. Of the 873 patients in clinical studies receiving Darbepoetin and concomitant cancer chemotherapy, 45% were age 65 and over, while 14% were age 75 and over. No differences in safety or efficacy were observed between older and younger patients.
","Darbepoetin overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Darbepoetin dosage and/or with phlebotomy, as clinically indicated. Cases of severe hypertension have been observed following overdose with ESAs
",,,"Store at 2°C to 8°C. Do not freeze. Do not shake. Protect from light; store Darbepoetin Alfa in the carton until use. Do not use Darbepoetin Alfa that has been shaken or frozen.
",12
+1550,Dapsone,dapsone-1550,https://medex.com.bd/attachments/tWfuNQMffb0J1ZkgHzFa3Qkfl8qbal/dapsone-prescribing-information,Acne treatment preparations,Acne vulgaris,"Dapsone is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
","Acne treatment preparations
","Dapsone has both anti-infammatory and antimicrobial properties. A combination of these activities may account for its efcacy in acne. Anti-infammatory efects include inhibition of neutrophil myeloperoxidase and eosinophil peroxidase activity, suppression of hypochlorous acid production, scavenging of reactive oxygen species, suppression of neutrophil activity, and inhibition of chemoattractant-induced signal transduction. Antimicrobial activity, similar to that of sulfones and sulfonamides, is by inhibition of bacterial dihydropteroate synthase in the folic acid metabolic pathway. This mechanism is efective against microorganisms synthesizing their own folic acid. In vitro susceptibility testing has demonstrated some activity for Dapsone against Propionibacterium species, including Propionibacterium acnes (P. acnes).
","After the skin is gently washed and patted dry, apply approximately a pea-sized amount of Dapsone in a thin layer to the entire face once daily. In addition, a thin layer may be applied to other afected areas once daily. Rub in Dapsone, gently and completely. If there is no improvement after 12 weeks, treatment with Dapsone should be reassessed. Not for oral, ophthalmic or intravaginal use.
",,"Trimethoprim/ sulfamethoxazole (TMP/ SMX) increases the systemic level of Dapsone and its metabolites.
Topical benzoyl peroxide used at the same time as Dapsone may result in temporary local yellow or orange skin discoloration.
","Those who are hypersensitive to Dapsone.
","Most common (incidence ≥ 0.9%) effects are application site dryness and pruritus.
","Pregnancy Category C. There are no adequate and well controlled studies in pregnant women. Dapsone should be used during pregnancy only if the potential beneft justifes the potential risk to the fetus.
Although systemic absorption of Dapsone following topical application of Dapsone is minimal relative to oral Dapsone administration, it is known that Dapsone is excreted in human milk. Because of the potential for oral Dapsone to cause adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Dapsone, taking into account the importance of the drug to the mother.
","Methemoglobinemia: Cases of methemoglobinemia have been reported. Discontinue Dapsone if signs of methemoglobinemia occur.
Hemolysis: Some patients with Glucose-6-Phosphate Dehydrogenase (G6PD) defciency using topical Dapsone developed laboratory changes suggestive of hemolysis.
","Pediatric Use: Safety and efectiveness of Dapsone have not been established in pediatric patients below the age of 12 years.
Geriatric Use: Clinical trials of Dapsone did not include sufcient numbers of subjects aged 65 years and over to determine whether they respond diferently from younger subjects.
",,,,"Store in a cool & dry place. Keep out of reach of children. Do not freeze.
",11
+320,Dapoxetine Hydrochloride,dapoxetine-hydrochloride-320,https://medex.com.bd/attachments/rhBMHKIVy3W1gLABOK5kjHWRGq8P0y/dapoxetine-hydrochloride-prescribing-information,Drugs for Erectile Dysfunction,Premature ejaculation,"Indicated for the treatment of premature ejaculation (PE) in men 18 to 64 years of age, who have all of the following:
+
+- Persistent or recurrent ejaculation with minimal sexual stimulation before, on or shortly after penetration and before the patient wishes.
+- Marked personal distress or interpersonal difficulty as a consequence of PE and poor control over ejaculation.
+
","Drugs for Erectile Dysfunction
","The mechanism of action is thought to be related to inhibition of neuronal reuptake of serotonin and subsequent potentiation of serotonin activity. The central ejaculatory neural circuit comprises spinal and cerebral areas that form a highly interconnected network. The sympathetic, parasympathetic, and somatic spinal centers, under the influence of sensory genital and cerebral stimuli integrated and processed at the spinal cord level, act in synergy to command physiologic events occurring during ejaculation. Experimental evidence indicates that serotonin (5-HT), throughout brain descending pathways, exerts an inhibitory role on ejaculation. To date, three 5-HT receptor subtypes 5-HT(1A), 5-HT(1B), and 5-HT(2C) have been postulated to mediate 5-HT's modulating activity on ejaculation.
","Adult (18 to 64 years of age): The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. If the effect of 30 mg is insufficient and the side effects are acceptable, the dose may be increased to the maximum recommended dose of 60 mg. The maximum recommended dosing frequency is one dose every 24 hours.
",,"CNS active medicinal products: The use of Dapoxetine in combination with CNS active medicinal products has not been systematically evaluated in patients with premature ejaculation. Consequently, caution is advised if the concomitant administration of Dapoxetine and such medicinal products is required.
PDE5 inhibitors: Tadalafil did not affect the pharmacokinetics of Dapoxetine. Sildenafil caused slight changes in Dapoxetine pharmacokinetics, which are not expected to be clinically significant. However, Dapoxetine should be prescribed with caution in patients who use PDE5 inhibitors due to possible reduced orthostatic tolerance.
Tamsulosin: Concomitant administration of single or multiple doses of 30 mg or 60 mg Dapoxetine to patients receiving daily doses of Tamsulosin did not result in changes in the pharmacokinetics of Tamsulosin. However, Dapoxetine should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance.
Warfarin: There are no data evaluating the effect of chronic use of Warfarin with Dapoxetine; therefore, caution is advised when Dapoxetine is used in patients taking Warfarin chronically.
Ethanol: Concomitant use of alcohol and Dapoxetine could increase the chance or severity of adverse reactions such as dizziness, drowsiness, slow reflexes, or altered judgment. Combining alcohol with Dapoxetine may increase these alcohol-related effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Dapoxetine.
","
+- Patients with known hypersensitivity to Dapoxetine Hydrochloride.
+- Patients with significant pathological cardiac conditions such as heart failure (NYHA class II-IV), conduction abnormalities (second or third degree AV block or sick sinus syndrome) not treated with a permanent pacemaker, significant ischemic heart disease of significant valvular disease.
+- Concomitant treatment with monoamine oxidase inhibitors (MAOIs), thioridazine. Similarly, MAOIs or thioridazine should not be administered within 7 days after Dapoxetine has been discontinued.
+- Concomitant treatment with serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs) or other medicinal/herbal products with serotonergic effects or within 14 days of discontinuing treatment with these medicinal/herbal products.
+
","Dizziness, Headache, Somnolence, Tremor, Blurred vision, Tinnitus, Sinus congestion, Nausea, Diarrhea, Abdominal pain, Dry mouth, Fatigue, Insomnia, Hypertension.
","Dapoxetine is not indicated for use by women. It is not known either dapoxetine or its metabolites are excreted through human breast milk.
","Patient with bleeding disorders, epilepsy, susceptibility to angle-closure glaucoma or raised intraocular pressure. Not intended for use in women. Known CYP2D6 poor metabolisers.
",,"There were no unexpected adverse events in a clinical pharmacology study of Dapoxetine with daily doses up to 240 mg. In general, symptoms of overdose with SSRIs include serotonin-mediated adverse reactions such as somnolence, gastrointestinal disturbances such as nausea and vomiting, tachycardia, tremor, agitation and dizziness. In cases of overdose, standard supportive measures should be adopted as required.
",,,"Store below 30°C. Protect from light and moisture. Keep out of reach of children
",11
+339,Dapagliflozin Propanediol,dapagliflozin-propanediol-339,https://medex.com.bd/attachments/cEXycbeMH7dMoK0KbtN7KypzftiYQb/dapagliflozin-propanediol-prescribing-information,Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors,Type 2 DM,"Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
","Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors
","Dapagliflozin is a highly potent, selective, and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2) that improves glycemic control in patients with type 2 diabetes mellitus by reducing renal glucose reabsorption leading to urinary excretion of excess glucose (glucuresis).
","5 mg orally once a day. May increase to 10 mg orally once a day in patients tolerating therapy with 5 mg and requiring additional glycemic control
",,"Hypoglycemia may occur with concomitant use with insulin & insulin secretagogues eg sulfonylureas. Decrease in Cmax & AUC with rifampin. Increase in Cmax & AUC with mefenamic acid. Increased thiazide & loop diuretic effects; may increase risk of dehydration & hypotension. Pioglitazone.
","Hypersensitivity to dapagliflozin propanediol or to any of the excipients. Moderate to severe renal impairment; end-stage renal disease; active bladder cancer. Pregnancy (2nd & 3rd trimester) & lactation.
","Renal impairment, Female genital mycotic infections, Urinary tract infection, Increased urination, Male genital mycotic infections, Dyslipidemia, Constipation, Discomfort with urination, Extremity pain, Volume depletion, Hypersensitivity
","Pregnancy Category-C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","CV disease, history of hypotension, UTI, Children, Elderly. Unknown whether distributed in human breast milk; breastfeeding women should discontinue dapagliflozin or nursing taking into account the importance of the drug to the mother
","Renal Impairment: No dosage adjustment is indicated based on renal function. The efficacy is dependent on renal function. lt is not recommended for use in patients with moderate to severe renal impairment (patients with CrCI <60 mL/min or eGFR <60 mL/min/1.73 m2).
",,,,,10
+319,Dantrolene Sodium,dantrolene-sodium-319,https://medex.com.bd/attachments/VYDCnWcwtq8dBjKIsHtChglAwC6TEG/dantrolene-sodium-capsules-prescribing-information,Centrally acting Skeletal Muscle Relaxants,Stroke,"In Chronic Spasticity: Dantrolene is indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuronal disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis). It is of particular benefit to the patients whose functional ... Read more
In Chronic Spasticity: Dantrolene is indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuronal disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis). It is of particular benefit to the patients whose functional rehabilitation has been retarded by the sequelae of spasticity. Such patients must have presumably reversible spasticity where relief of spasticity will aid in restoring residual function. Dantrolene is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. Occasionally, subtle but meaningful improvement in spasticity may occur with Dantrolene therapy. In such instances, information regarding improvement should be solicited from the patient. Brief withdrawal of Dantrolene for a period of 2 to 4 days will frequently demonstrate exacerbation of the manifestations of spasticity and may serve to confirm a clinical impression.
A decision to continue the administration of Dantrolene on a long-term basis is justified if introduction of the drug into the patient's regimen:
+
+- produces a significant reduction in painful and/or disabling spasticity such as clonus, or
+- permits a significant reduction in the intensity and/or degree of nursing care required, or
+- rids the patient of any annoying manifestation of spasticity considered important by the patient himself.
+
+
In Malignant Hyperthermia: Oral Dantrolene is also indicated preoperatively to prevent or attenuate the development of signs of malignant hyperthermia in known, or strongly suspect, malignant hyperthermia susceptible patients who require anesthesia and/or surgery. Oral Dantrolene should be administered following a malignant hyperthermic crisis to prevent recurrence of the signs of malignant hyperthermia.
","Centrally acting Skeletal Muscle Relaxants
","Dantrolene produces relaxation by affecting the contractile response of the skeletal muscle at a site beyond the myoneural junction, directly on the muscle itself. In skeletal muscle, Dantrolene dissociates the excitation-contraction coupling, probably by interfering with the release of Ca++ from the sarcoplasmic reticulum.
","For Use in Chronic Spasticity:
+
+- Adults: The following gradual titration schedule is suggested. Some patients will not respond until higher daily dosage is achieved. Each dosage level should be maintained for seven days to determine the patient's response. If no further benefit is observed at the next higher dose, dosage should be decreased to the previous lower dose.
+- Starting dose is 25 mg twice per day and it can be increased to 25-50 mg per day per week. Maximum accepted dosage is 400 mg per day.
+- Paediatric Patients: The following gradual titration schedule is suggested. Some patients will not respond until higher daily dosage is achieved. Each dosage level should be maintained for seven days to determine the patient's response. If no further benefit is observed at the next higher dose, dosage should be decreased to the previous lower dose.
+- 0.5 mg/kg once daily for seven days, then 0.5 mg/kg 3 times for 7 days, 1 mg/kg 3 times for 7 days, 2 mg/kg 3 times a day, Therapy with a dose 4 times daily may be necessary for some individuals.
+
+For Malignant Hyperthermia
+
+- Preoperatively: Administer 4 to 8 mg/kg/day of oral Dantrolene in 3 or 4 divided doses for one or two days prior to surgery, with the last dose being given approximately 3 to 4 hours before scheduled surgery with a minimum of water.
+- Post Crisis Follow-up: Oral Dantrolene should also be administered following a malignant hyperthermia crisis, in doses of 4 to 8 mg/kg per day in four divided doses, for a one to three day period to prevent recurrence of the manifestations of malignant hyperthermia.
+
",,"Drowsiness may occur with Dantrolene therapy, and the concomitant administration of CNS depressants such as sedatives and tranquilizing agents may result in further drowsiness. Hepatotoxicity has occurred more often in women over 35 years of age receiving concomitant estrogen therapy.
","Active hepatic disease, such as hepatitis and cirrhosis.
","The most frequently occurring side effects of Dantrolene have been drowsiness, dizziness, weakness, general malaise, fatigue, and diarrhea. These are generally transient, occurring early in treatment, and can often be obviated by beginning with a low dose and increasing dosage gradually until an optimal regimen is established. Diarrhea may be severe and may necessitate temporary withdrawal of Dantrolene therapy. If diarrhea recurs upon readministration of Dantrolene, therapy should probably be withdrawn permanently
","Pregnancy Category C. Dantrolene capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Dantrolene should not be used in nursing mothers.
","In view of the potential for liver damage in long-term Dantrolene use, therapy should be stopped if benefits are not evident within 45 days. Patients should be cautioned against driving a motor vehicle or participating in hazardous occupations while taking Dantrolene. Caution should be exercised in the concomitant administration of tranquilizing agents. Dantrolene might possibly evoke a photosensitivity reaction; patients should be cautioned about exposure to sunlight while taking it. It is important to recognize that fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur with Dantrolene therapy. At the start of Dantrolene therapy, it is desirable to do liver function studies (SGOT, SGPT, alkaline phosphatase, total bilirubin) for a baseline or to establish whether there is preexisting liver disease. Liver function studies (e.g., SGOT or SGPT) should be performed at appropriate intervals during Dantrolene therapy. Some patients have revealed a return to normal laboratory values in the face of continued therapy while others have not. If symptoms compatible with hepatitis, accompanied by abnormalities in liver function tests or jaundice appear, Dantrolene should be discontinued. If caused by Dantrolene and detected early, the abnormalities in liver function characteristically have reverted to normal when the drug was discontinued. Dantrolene therapy has been reinstituted in a few patients who have developed clinical and/ or laboratory evidence of hepatocellular injury. If such reinstitution of therapy is done, it should be attempted only in patients who clearly need Dantrolene and only after previous symptoms and laboratory abnormalities have cleared. The patient should be hospitalized and the drug should be restarted in very small and gradually increasing doses. Laboratory monitoring should be frequent and the drug should be withdrawn immediately if there is any indication of recurrent liver involvement. Dantrolene should be used with particular caution in females and in patients over 35 years of age in view of apparent greater likelihood of drug-induced, potentially fatal, hepatocellular disease in these groups.
Dantrolene should be used with caution in patients with impaired pulmonary function, and in patients with severely impaired cardiac function due to myocardial disease. It should be used with caution in patients with a history of previous liver disease or dysfunction.
","Usage in Paediatric Patients: The long-term safety of Dantrolene in paediatric patients under the age of 5 years has not been established. Because of the possibility that adverse effects of the drug could become apparent only after many years, a benefit-risk consideration of the long-term use of Dantrolene is particularly important in pediatric patients.
",,,,"Store in a cool & dry place, protected from light.
",11
+318,Danazol,danazol-318,https://medex.com.bd/attachments/tlXQzIN7mr8CyizMKZEwRhJ2PKsJxX/danazol-prescribing-information,Drugs affecting (inhibiting) gonadotrophin,Uterine fibroids,"Danazol is indicated for the following treatment-
+
+- Endometriosis
+- Benign breast disease
+- Menorrhagia
+- Gynecomastia
+- Preoperative thinning of the endometrium before hysteroscopic endometrial ablation.
+
","Drugs affecting (inhibiting) gonadotrophin
","As a gonadotropin inhibitor, danazol suppresses the pituitary-ovarian axis possibly by inhibiting the output of pituitary gonadotropins. Danazol also depresses the preovulatory surge in output of follicle-stimulating hormone (FSH) and luteinizing hormone (LH), thereby reducing ovarian estrogen production. Danazol may also directly inhibits ovarian steroidogenesis; bind to androgen, progesterone, and glucocorticoid receptors; bind to sex-hormone-binding globulin and corticosteroid-binding globulin; and increases the metabolic clearance rate of progesterone. Another mechanism of action by which danazol may use to facilitate regression of endometriosis is by decreasing IgG, IgM, and IgA concentrations, as well as phospholipid and IgG isotope autoantibodies. In the treatment of endometriosis, as a consequence of suppression of ovarian function, danazol causes both normal and ectopic endometrial tissues to become inactive and atrophic. This leads to anovulation and associated amenorrhea. In fibrocystic breast disease, the exact mechanism of action of danazol is unknown, but may be related to suppressed estrogenic stimulation as a result of decreased ovarian production of estrogen. A direct effect on steroid receptor sites in breast tissue is also possible. This leads to a disappearance of nodularity, relief of pain and tenderness, and possibly changes in the menstrual pattern. In terms of hereditary angioedema, danazol corrects the underlying biochemical deficiency by increasing serum concentrations of the deficient C1 esterase inhibitor, resulting in increased serum concentrations of the C4 component of the complement system.
","Preoperative thinning of the endometrium:
+
+- Adult: 400-800 mg daily, in up to 4 divided doses for 3-6 week.
+
+Benign breast disorders:
+
+- Adult: Initially, 100-400 mg daily in 2 divided doses adjusted according to response and continued for 3-6 month.
+
+Hereditary angioedema:
+
+- Adult: Initially, 200 mg bid-tid reduced thereafter according to patient's response.
+
+Endometriosis:
+
+- Adult: 200-800 mg daily in 2 divided doses adjusted according to response, for 3-6 month or if necessary, up to 9 month.
+
+Menorrhagia:
+
+- Adult: 200 mg once daily. Review treatment 3 month later.
+
+Gynaecomastia:
+
+- Adult: Male adolescents: Initially, 200 mg daily, may increase to 400 mg daily after 2 month if no response occurs; adult men: Initial: 400 mg daily in up to 4 divided doses. Usual treatment duration: 6 month.
+- Child: Male adolescents: Initially, 200 mg daily increased to 400 mg after 2 month if no response occurs. Treatment usually up to 6 months.
+
",,"Insulin: Patients taking danazol may show increased insulin resistance. The significance of this is not known but such patients should be carefully monitored.
Estrogens and progestogens: Theoretically danazol may interact with exogenous estrogens and/or progestogens. It has been suggested that danazol acts by binding to estrogen, progesterone or androgen receptors at various levels in the hypothalamic pituitary-ovarian axis. Therefore, women of child bearing age should use effective, non hormonal methods of contraception.
Anticonvulsant therapy: Danazol may affect the plasma concentration of carbamazepin and possibly the patient's response to this agent and to phenytoin. A similar interaction is possible for phenobarbital.
Antihypertensive therapy: Danazol can oppose the action of antihypertensive agents, possibly through effects on fluid retention.
Cyclosporine: Danazol can increase the plasma concentration of cyclosporine.
Migraine therapy: Danazol itself may provoke migraine and it may possibly reduce the effectiveness of medication to prevent the condition.
","
+- Pregnancy and breast-feeding
+- Impaired hepatic, renal, or cardiac function
+- Porphyria
+- Thromboembolic disease
+- Androgen-dependent tumor
+- Abnormal vaginal bleeding that has not been fully investigated.
+- Hypersensitivity to danazol.
+
","Oedema, weight gain, sweating, acne, hirsutism, flushing, oily skin or hair, deepening of the voice, clitoral hypertrophy, amenorrhoea, hepatic dysfunction, CNS or GI disturbances, benign intracranial hypertension, reduction in breast size, visual disturbances, elevated LFT values.
","Category X: Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
","Epilepsy, migraine; cardiac, hepatic, renal disorders. Severe hypertension, diabetes, polycythaemia, history of thrombosis; children.
",,"There have been no incidents of acute overdosage with Danazol and it is unlikely that any immediate serious reaction will be seen from a single excessive dose. In case of the acute overdosage, the drug should be removed by gastric lavage and the patient should be kept under observation.
",,,"Store at 15-30°C.
",11
+317,Dalteparin Sodium,dalteparin-sodium-317,https://medex.com.bd/attachments/GNLCe9cSFdfzODBQoKgaTmbDtApzfH/dalteparin-sodium-prescribing-information,Parenteral anti-coagulants,Unstable angina,"Prophylaxis of clotting in extracorporeal circulation in haemodialysis or haemofiltration, Prophylaxis of clotting in extracorporeal circulation in haemodialysis or haemofiltration, Unstable angina, Prophylaxis of venous thromboembolism during surgical procedures, Venous thromboembolism
","Parenteral anti-coagulants
","Dalteparin Na is an antithrombotic agent, which acts mainly through its ability to potentiate the inhibition of factor Xa and thrombin by antithrombin. It has a relatively higher ability to potentiate factor Xa inhibition than to prolong aPTT.
","Intravenous-
+
+- Prophylaxis of clotting in extracorporeal circulation in haemodialysis or haemofiltration: 30-40 U/kg IV inj, then 10-15 U/kg/hr as IV infusion.
+
+Subcutaneous-
+
+- Venous thromboembolism: 200 U/kg/day as a single or in 2 divided doses in pregnant and high-risk patients. Max: 18,000 U/day.
+- Prophylaxis of venous thromboembolism during surgical procedures Moderate risk: 2,500 U given 1-2 hr pre-op then 2,500 U once daily for 5-7 days or until the patient is fully ambulant. High risk: 2,500 U given 1-2 hr before and 8-12 hr after the procedure then 5,000 U daily.
+- Unstable angina: 120 U/kg 12 hrly continued for 5-8 days w/ low-dose aspirin. Max: 10,000 U 12 hrly.
+
",,"Increased risk of haemorrhage with other anticoagulant/ antiplatelet agents (e.g. aspirin/ dipyridamole, glycoprotein IIb/ IIIa receptor antagonists, vit K antagonists, NSAIDs, cytostatics, dextran, thrombolytics, sulfinpyrazone, probenecid, etacrynic acid). Reduced anticoagulant effect with antihistamines, cardiac glycosides, tetracycline and ascorbic acid.
","Hypersensitivity. Active major bleeding, severe coagulation disorders; lumbar puncture; sympathetic block; brain, spinal cord, eye or ear surgery; severe hypertension
","Elevated serum transaminase levels (AST and ALT), allergic reactions (e.g. pruritus, rash, fever, inj site reaction, bullous eruption), pain on inj site. Epidural or spinal haematomas that may result in permanent paralysis, severe haemorrhage, thrombocytopenia.
","Pregnancy Category B. Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
","Patient with increased risk of bleeding complications (e.g. following surgery or trauma, haemorrhagic stroke, thrombocytopenia or defective platelet function, uncontrolled HTN, hypertensive or diabetic retinopathy). Increased risk of spinal or epidural haematomas in patient undergoing neuraxial anaesth or spinal puncture esp with post-op use of indwelling epidural catheters. Hepatic and renal impairment. Pregnancy and lactation.
",,"Symptoms: Haemorrhagic complications.
Management: Administer protamine sulfate by slow IV inj at a dose of 1 mg for every 100 anti-Xa U of dalteparin Na given.
",,,"Store between 20-25°C.
",11
+346,Dextromethorphan + Pseudoephedrine + Triprolidine,dextromethorphan-pseudoephedrine-triprolidine-346,https://medex.com.bd/attachments/1PZlhA3ef5V9m9qoUap9USGaIhUKrA/dextromethorphan-pseudoephedrine-triprolidine-prescribing-information,Combined cough suppressants,Non-productive cough,"This preparation temporarily relieves these symptoms due to common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
+
+- Non-productive cough due to minor throat or bronchial irritation
+- Runny Nose
+- Sneezing
+- Itching of the nose or throat
+- Itchy & watery eyes
+- Nasal congestion
+
","Combined cough suppressants
","This preparation is a mixture of antitussive, decongestant and antihistamine agent. Dextromethorphan is a safe, effective, non-narcotic antitussive agent which has a central action on the cough centre in the medulla. Although structurally related to Morphine, it has no analgesic and habit forming properties and in general it has little sedative activity. Phenylephrine is a decongestant that shrinks blood vessels in the nasal passage. Phenylephrine is used for the temporary relief of stuffy nose, sinus, and ear symptoms caused by the common cold, flu, allergies, sinusitis & bronchitis. This medication works by decreasing swelling in the nose and ears, thereby lessening discomfort and making it easier to breathe. Triprolidine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms include rash, watery eyes, itchy eyes/nose/throat/skin, cough, runny nose, and sneezing. It is a potent competitive histamine H1-receptor antagonist of the pyrrolidine class with mild central nervous system depressant properties which may cause drowsiness. By antagonizing another natural substance acetylcholine, it helps dry up some body fluids to relieve symptoms such as watery eyes and runny nose.
","Adults & Children over 12 years: 1 teaspoonful (5 ml) 4 times a day every 4 hours interval.
6-12 years: 1/2 teaspoonful 4 times a day every 4 hours interval.
Use in children and adolescents: A physician's advice should be obtained before administering this combination to children less than 6 years.
",,"Taking certain MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking isocarboxazid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, or tranylcypromine during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication.
","It should be avoided in patients with liver disease or asthmatic patients and is contraindicated in patients taking monoamine oxidase inhibitors or within 2 weeks from stopping such treatment
","It may cause drowsiness and constipation. Other side effects that may occur include GIT discomfort. No apparent evidence of physical dependence of the morphine type.
","There are no specific data on use of this combination during pregnancy & lactation.
","This preparation may cause drowsiness. If affected, do not drive motor vehicle or operate machinery. Avoid alcoholic drink while on this medication. Use with caution in patients with epilepsy, prostatic hypertrophy, glaucoma, hepatic disease, hypertension, heart disease, diabetes, hyperthyroidism. If symptoms do not improve within one week or accompanied with high fever, consult a physician before continuing use.
",,"In cases of over dosage, hospital admission is strongly advised. Over dosage may produce respiratory depression, paranoid psychosis, delusions, hallucinations and convulsion.
",,,"Store in a cool and dry place (below 30°C temperature), away from light. Keep out of the reach of children.
",11
+1303,Dextromethorphan + Phenylephrine + Triprolidine,dextromethorphan-phenylephrine-triprolidine-1303,https://medex.com.bd/attachments/pZLzdpFGtfjHc9EAvkPTP6yYP8Pv6L/dextromethorphan-phenylephrine-triprolidine-prescribing-information,Combined cough suppressants,Sneezing,"Temporarily relieves these symptoms due to common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
+
+- cough due to minor throat or bronchial irritation
+- runny nose
+- sneezing
+- itching of the nose or throat
+- itchy, watery eyes
+- nasal congestion
+- reduces swelling of nasal passages
+
","Combined cough suppressants
","This preparation is a mixture of antitussive, decongestant and antihistamine agent. Dextromethorphan is a safe, effective, non-narcotic antitussive agent which has a central action on the cough centre in the medulla. Although structurally related to Morphine, it has no analgesic and habit forming properties and in general it has little sedative activity. Phenylephrine is a decongestant that shrinks blood vessels in the nasal passage. It is used to treat nasal and sinus congestion of the tubes that drain fluid from inner ear. Triprolidine provides symptomatic relief in conditions believed to depend wholly or partly upon the triggered release of histamine. It is a potent competitive histamine H1-receptor antagonist of the pyrrolidine class with mild central nervous system depressant properties which may cause drowsiness.
","Adults & Children 12 years of age and older: 1 teaspoonful (5 ml) every 4 hours, or as directed by a doctor.
Children 6 to under 12 years of age: ½ teaspoonful (2.5 ml) every 4 hours, or as directed by a doctor.
Children below 2 years old: Not to be used in children below 2 years old. To be used with caution, and as advised by the physician for children age 2 to 6 years.
","Take with or without food. Take with food if it causes an upset stomach. Measure liquid doses carefully. Use the measuring device that comes with this medicine.
","Taking certain MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking isocarboxazid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, or tranylcypromine during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Caution should be excercised while taking this drug with antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray), antispasmodics (e.g. atropine, belladonna alkaloids), beta blockers (e.g. metoprolol, atenolol), drugs for Parkinson’s disease (e.g. anticholinergics such as benztropine, trihexyphenidyl), guanethidine, certain inhaled anesthetics (e.g. halothane), methyldopa, reserpine, scopolamine, tricyclic antidepressants (e.g. amitriptyline, desipramine), anti seizure drugs (e.g. carbamazepine), medicine for sleep or anxiety (e.g. alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g. codeine), psychiatric medicines (e.g. chlorpromazine, risperidone, amitriptyline, trazodone).
","It should be avoided in patients with liver disease or asthmatic patients and is contraindicated in patients taking monoamine oxidase inhibitors or within 2 weeks from stopping such treatment, known hypersensitivity to phenylephrine hydrochloride, dextromethorphan hydrobromide and during acute attacks of asthma. It is contraindicated in patients with severe hypertension or severe coronary artery disease.
","It may cause drowsiness, dottiness and constipation. Other side effects that may occur include GIT discomfort. No apparent evidence of physical dependence of the morphine type. Other less common side effects may include transient hypertension, dry mouth, restlessness, palpitations, allergic reactions such as rashes, tightness of chest, thickening of bronchial secretions, toxic psychosis and blood dyscrasia.
","As with any other drugs, use in pregnancy and lactation is best avoided.
","This preparation may cause drowsiness. If affected, do not drive motor vehicle or operate machinery. Avoid alcoholic drink while on this medication. Use with caution in patients with epilepsy, prostatic hypertrophy, glaucoma, hepatic disease, hypertension, heart disease, diabetes, hyperthyroidism, patients with stenosing peptic ulcer, pyloro-duodenal obstruction or bladder neck obstruction, unless under the medical advice and supervision. If symptoms do not improve within one week or accompanied with high fever, consult a physician before continuing use.
",,"In cases of over dosage, hospital admission is strongly advised. Over dosage may produce respiratory depression, paranoid psychosis, delusions, hallucinations, and convulsion. Treatment should include emptying the stomach by aspiration or gastric lavage. Nervous stimulation and convulsions should be treated with a sedative such as diazepam intramuscularly. If marked excitation is present, a sedative such as diazepam or a short-acting barbiturate may be given.
Severe over dosage of phenylephrine hydrochloride may produce hypertension and associated reflex bradycardia. Treatment measures include early gastric lavage and symptomatic and supportive measures. The hypertensive effects may be treated with an alpha-receptor blocking agent (such as phentolamine mesilate 6-10 mg) given intravenously, and the bradycardia treated with atropine, preferable only after the pressure has been controlled.
",,,"Keep out of the reach of children. Keep in a cool & dry place. Protect from light.
",12
+348,Dextran + Sodium Chloride,dextran-sodium-chloride-348,,Plasma expanders,Venous thrombosis,"This is indicated in Aid in Hysteroscopy, Thromboembolic disorders, Prophylaxis of pulmonary embolism or venous thrombosis in moderate- to high-risk patients undergoing surgery, Prophylaxis of postoperative thromboembolic disorders, Hypovolaemic shock.
","Plasma expanders
","Dextran produce expansion of plasma volume. It also reduces blood viscosity and inhibits sludging or aggregation of red blood cells.
Sodium chloride is the major extracellular cation. It is important in electrolyte and fluid balance, osmotic pressure control and water distribution as it restores sodium ions. It is used as a source of electrolytes and water for hydration, treatment of metabolic acidosis, priming solution in haemodialysis and treatment of hyperosmolar diabetes. It is also used as diluents for infusion of compatible drug additives.
","Intrauterine-Aid in hysteroscopy:
+
+- Adult: As dextran 70: 50-100 mL of a 32% solution instilled into the uterus as a rinsing and dilatation fluid.
+
+
Intravenous-Thromboembolic disorders:
+
+- Adult: As dextran 40: Initially, 500 ml of a 10% solution in sodium chloride 0.9% or glucose 5% infused over 4-6 hr, followed by 500 ml infused over 4-6 hr on the next and subsequent alternate days for not more than 10 days.
+- Child: As dextran 40: Up to 5 ml/kg in infants and 10 ml/kg in children.
+
+
Intravenous-Prophylaxis of pulmonary embolism or venous thrombosis in moderate- to high-risk patients undergoing surgery:
+
+- Adult: As dextran 70: Initially, 500-1000 mL of a 6% solution in sodium chloride 0.9% or glucose 5% infused over 4-6 hr during or immediately after surgery, followed by 500 mL on the next day and on subsequent alternate days for up to 2 wk after surgery in high-risk patients.
+
+
Intravenous-Prophylaxis of postoperative thromboembolic disorders:
+
+- Adult: As dextran 40: 500 ml of a 10% solution in sodium chloride 0.9% or glucose 5% infused over 4-6 hr during or at the end of the surgery. Dose may be repeated the following day and treatment may be continued on alternate days for up to 10 days in high-risk patient.
+- Child: As dextran 40: Up to 10 ml/kg in children.
+
+
Intravenous-Hypovolaemic shock:
+
+- Adult: As dextran 40: Initially, 10 ml/kg given by rapid infusion as a 10% solution in sodium chloride 0.9% or glucose 5%. Doses may be given daily for up to 5 days. As dextran 70: Initially, 500-1000 mL of a 6% solution in sodium chloride 0.9% or glucose 5% infused at a rate of 20-40 mL/min. Maintenance: 10 ml/kg/day for3 days (Dextran 70).
+
",,"Dextran: Enzyme inducers e.g. phenytoin or carbamazepine and enzyme inhibitors e.g. cimetidine.
Sodium Chloride: May affect serum concentrations of lithium.
","Hypersensitivity. Severe renal disease with oliguria or anuria. Marked cardiac decompensation. Pregnancy.
","GI disturbances; headache, dizziness; allergic reactions; raised liver enzyme values; alopecia; bone marrow suppression.
","Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Lactation.
",,,,,"Store at 25°C.
",10
+345,Dextran + Hypromellose,dextran-hypromellose-345,https://medex.com.bd/attachments/0CqtKijflPg5cX73jfRwcCDk5sgi7v/dextran-hypromellose-prescribing-information,Drugs for Dry eyes,Dry eye,"As a lubricant and artificial tear in dry eye and other ocular irritation syndromes associated with deficient tear or mucous secretion. This combination also prevents cornea to damage in patients with keratoconjunctivitis and for ocular lubrication. It is also used for the temporary relief of burning and irritation due to dryness of the eye and for use as the protectant against further irritation.
","Drugs for Dry eyes
","Dextran & Hypromellose combination Eye drops acts like natural tears, which provides smoothing relief to dry, itchy, burning and irritated eyes. It helps eyes to stay moist
healthy and protects against further irritation. This unique combination of ingredients works together to retain moisture on the eye and slow evaporation of the tear film.
Hypromellose promotes corneal wetting by stabilizing and thickening the precorneal tear film and prolonging the tear film breakup time, which is usually shortened in dry eye conditions. Also acts to lubricate and protect the eye. Dextran is a complex branched glucan composed of chains of varying lengths. It is used medicinally as an antithrombotic, to reduce blood viscosity, and as a volume expander in hypovolaemia.
","Adults and children: One or two drops three times daily or as directed by the physician.
",,,"This product contains Benzalkonium Chloride and should not be used when soft contact lenses are being worn.
","There are no known side effects with the use of it, however, if the patient experiences any reaction in eye or other part of the body after using this medication then consult with doctor
","There is insufficient evidence as to the safety in pregnancy and lactation. Therefore, this product should only be used in pregnancy and lactation if it is considered essential by the physician.
","If irritation persists or if the condition does not improve, patient should seek further advice from doctor.
",,,,,"Store below 25°C and do not freeze. Do not use after 30 days of first opening. Keep the container closed tightly after each opening. Keep out of the reach of children.
",9
+349,Dextran + Dextrose,dextran-dextrose-349,https://medex.com.bd/attachments/FuKbZk2TryZUXa1EajxFobQYFQU0v4/dextran-dextrose-prescribing-information,Plasma expanders,Venous thrombosis,"This is indicated in thromboembolic disorders, hypovolaemic shock, pulmonary embolism, venous thrombosis
","Plasma expanders
","Dextrans produce expansion of plasma volume. It also reduces blood viscosity and inhibits sludging or aggregation of red blood cells.
Dextrose is a monosaccharide that is used as a source of calories and water for hydration. It helps to reduce loss of body protein and nitrogen. It also promotes glycogen deposition in the liver. When used with insulin, it stimulates the uptake of potassium by cells, especially in muscle tissue, thus lowering serum potassium levels.
","Adult: IV Hypovolaemic shock As dextran 40 (10% soln): 10 mL/kg/day for up to 5 days.
Thromboembolic disorders:
+
+- As dextran 40 (10% soln): Initial: 500 ml on day 1, followed by 500 ml on day 2 and subsequently on alternate days up to 10 days. Prophylaxis of post-op thromboembolic disorders. 500 ml during or at the end of surgery. May repeat dose next day and continue treatment on alternate days for up to 10 days in high-risk patients.
+
+
Child: As dextran 40: Up to 5 ml/kg in infants and 10 ml/kg in children.
","Hypersensitivity. Severe renal disease with oliguria or anuria. Marked cardiac decompensation. Pregnancy.
","Dextran:
+
+- Enzyme inducers e.g. phenytoin or carbamazepine
+- enzyme inhibitors e.g. cimetidine.
+
",,"Congestive heart failure, Mild hypotension, Tightness of chest, Thrombocytopenia, Anaphylaxis, Injection site infection/phlebitis, Acute renal failure, Acidosis (if NaCI soln used), Pulmonary edema, Wheezing
","Pregnancy Category - C
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","Caution should be taken during pregnency
",,,,,,9
+1565,Dexpanthenol,dexpanthenol-1565,,Miscellaneous topical agents,Scaly or itchy scalps,"Dexpanthenol is indicated in-
+
+- For prevention and treatment of diaper rash in infants.
+- For prevention and treatment of cracked or sore nipples in nursing women.
+- For prevention and treatment of chafed, cracked or split skin.
+- For treatment of light skin wounds and dry skin
+
","Miscellaneous topical agents
","Dexpanthenol is an alcohol derivative of pantothenic acid, a component of the B complex vitamins and an essential component of a normally functioning epithelium. Dexpanthenol is enzymatically cleaved to form pantothenic acid, which is an essential component of Coenzyme A, which acts as a cofactor in many enzymatic reactions that are important for protein metabolism in the epithelium.
Dermatological effects of the topical use of dexpanthenol include increased fibroblast proliferation and accelerated re-epithelialization in wound healing. Furthermore, it acts as a topical protectant, moisturizer, and has demonstrated anti-inflammatory properties
","Check with the doctor or pharmacist if you are unsure how to use Dexpanthenol.
The usual dosage is generally:
+
+- Diaper rash: Apply a thin layer on the baby’s bottom at every diaper change.
+- Nipples: Apply a thin layer on the nipples after each nursing session. Wash the nipples thoroughly before the next nursing session.
+- Dry/cracked skin or light wounds and chafed skin: Apply to the dry areas and/or to the wound up to 3 times a day.
+
+Do not exceed the recommended dose, Do not swallow. This medicine is intended for external use only.
",,,,"As with any medicine, use of Dexpanthenol may cause side effects in some users. Do not be alarmed by the list of side effects. You may not suffer from any of them. Discontinue use and refer to a doctor immediately in the event of: Allergic reaction and/or allergic skin reaction such as: atopic dermatitis, allergic dermatitis, pruritus, redness, rash, eczema, urticaria, local irritation or blistering. If a side effect occurs, worsens, or if you suffer from a side effect not mentioned in this leaflet, consult with the doctor.
",,,,,,,"Do not store above 30 degree Celsius. Keep away from light and out of the reach of children.
",6
+1403,Dexmedetomidine Hydrochloride,dexmedetomidine-hydrochloride-1403,https://medex.com.bd/attachments/kZsGt3v4FyrjkmabL1BgCNYSzMlGxI/dexmedetomidine-hydrochloride-prescribing-information,Miscellaneous sedatives & hypnotics,Sedation,"Dexmedetomidine Hydrochloride Injection is a central alpha-2 adrenergic agonist indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures
","Miscellaneous sedatives & hypnotics
","Dexmedetomidine is a specific and selective alpha-2 adrenoceptor agonist. By binding to the presynaptic alpha-2 adrenoceptors, it inhibits the release if norepinephrine, therefore, terminate the propagation of pain signals. Activation of the postsynaptic alpha-2 adrenoceptors inhibits the sympathetic activity decreases blood pressure and heart rate.
","Dilute in 0.9% Sodium Chloride Injection to concentration of 4 mcg/mL prior to administration.
To be administered only by health care providers skilled in the management of patients in the operating room setting.
Administer intravenously using a controlled infusion device. Administration duration should not exceed 24 hours.
Continuously monitor blood pressure, heart rate, and oxygen levels during administration and as clinically appropriate after discontinuation.
Initiation of Procedural Sedation:
+
+- More invasive procedures or awake fiberoptic intubation: 1 mcg/kg over 10 minutes
+- Less invasive procedures such as ophthalmic surgery: 0.5 mcg/kg over 10 minutes
+
+Maintenance of Procedural Sedation
+
+- All procedures except awake fiberoptic intubation: Generally, initiate at 0.6 mcg/kg/hour and titrate to achieve desired clinical effect with dosages ranging from 0.2 to 1 mcg/kg/hour.
+- Awake fiberoptic intubation: Administer 0.7 mcg/kg/hour until the endotracheal tube is secured
+
",,"Anesthetics, sedatives/hypnotics, opioids: Can potentiate sedating effects. Consider reducing dosage of dexmedetomidine HCl or co-administered drug.
","None
","The most common adverse reactions (incidence greater than 10%) were hypotension, respiratory depression, and bradycardia.
","Pregnancy: There are no studies conducted with dexmedetomidine hydrochloride in pregnant women to inform any drug-associated risks.
Lactation: There is no information regarding the presence of dexmedetomidine hydrochloride in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production.
","Bradycardia and Sinus Arrest: Consider decreasing or stopping dexmedetomidine HCl infusion; decreasing or stopping other medications that depress sinus node function; administering anticholinergic agents (e.g., glycopyrrolate, atropine); and/or administering pressor agents.
Hypotension: Consider decreasing or stopping dexmedetomidine HCl infusion; increasing rate of intravenous fluid administration; elevating lower extremities, and/or administering pressor agents.
Transient Hypertension: Observed primarily during administration of loading dose. Consider reducing loading infusion rate.
Arousability: Patients can become aroused/alert with stimulation; this alone should not be considered as lack of efficacy.
Prolonged exposure to dexmedetomidine beyond 24 hours may be associated with tolerance and tachyphylaxis and a dose-related increase in adverse events.
","Geriatric patients (age greater than 65 years): Recommended loading infusion dosage for initiation of procedural sedation is 0.5 mcg/kg over 10 minutes. Consider dosage reduction for maintenance
Hepatic impairment: Consider dosage reduction for initiation and maintenance of procedural sedation.
",,,,,10
+344,Dexlansoprazole,dexlansoprazole-344,https://medex.com.bd/attachments/34dyT7NJ5y8lfz7bOdgucc0IO8PBOT/dexlansoprazole-prescribing-information,Proton Pump Inhibitor,Oesophagitis,"Healing of Erosive Esophagitis: Dexlansoprazole is indicated for the healing of all grades of erosive esophagitis (EE) for up to 8 weeks.
Maintenance of Healed Erosive Esophagitis: Dexlansoprazole is indicated to maintain healing of EE and relief of heartburn ... Read more
Healing of Erosive Esophagitis: Dexlansoprazole is indicated for the healing of all grades of erosive esophagitis (EE) for up to 8 weeks.
Maintenance of Healed Erosive Esophagitis: Dexlansoprazole is indicated to maintain healing of EE and relief of heartburn for up to 6 months.
Symptomatic Non-Erosive Gastroesophageal Reflux Disease: Dexlansoprazole is indicated for the treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD) for 4 weeks.
","Proton Pump Inhibitor
","Dexlansoprazole delayed-release capsule is a Proton Pump Inhibitor (PPI) which suppresses gastric acid secretion by specific inhibition of the (H+/K+)-ATPase in the gastric parietal cell. By acting specifically on the proton pump, Dexlansoprazole blocks the final step of acid production. It is the R-enantiomer of lansoprazole (A racemic mixture of the R- and S-enantiomers). Dexlansoprazole is supplied as a Dual Delayed Release (DDR) formulation in a capsule for oral administration. This capsule contains a mixture of two types of enteric coated granules with different pH-dependent dissolution profiles. The dual delayed release formulation in dexlansoprazole, plasma concentration-time profile with two distinct peaks; the first peak occurs 1 to 2 hours after administration, followed by a second peak within 4 to 5 hours. After oral administration, mean Cmax and AUC value of Dexlansoprazole increased approximately dose proportionally. Dexlansoprazole is extensively metabolized in the liver and excreated by urine.
","Dexlansoprazole dosing recommendations-
+
+- Maintenance of Healed erosive esophagitis and relief of heartburn: 30 mg Once daily
+- Symptomatic Non-Erosive GERD: 30 mg Once daily for 4 weeks
+- Healing of erosive esophagitis: 60 mg Once daily for up to 8 weeks
+
","Dexlansoprazole can be taken without regard to food. It should be swallowed whole.
Alternatively, Dexlansoprazole capsules can be administered as follows:
+
+- Open capsule
+- Sprinkle intact granules on one tablespoon
+- Swallow immediately.
+
+Granules should not be chewed.
If a capsule is missed at its usual time, it should be taken as soon as possible. But if it is too close to the time of the next dose, only the prescribed dose should be taken at the appointed time. A double dose should not be taken.
","With medicine: Atazanavir, Warfarin, Tacrolimus, Clopidogrel & Methotrexate. With food & others: No data available.
","Dexlansoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.
","Common side effects: Diarrhea, abdominal pain, nausea, vomiting & flatulence.
","Pregnancy Category B. There is no adequate and well-controlled studies with Dexlansoprazole in pregnant women. There is no adequate and well-controlled studies with Dexlansoprazole in Lactating mother.
","Gastric Malignancy, Clostridium difficile Associated Diarrhea, Bone fracture, Hypomagnesemia, and concomitant use of Dexlansoprazole with Methotrexate.
","Use in children & adolescents: Safety and effectiveness of Dexlansoprazole in patients below 12 years age have not been established.
Geriatric use: No dose adjustment is necessary for elderly patients.
Renal impairment: No dose adjustment of Dexlansoprazole is necessary for patients with renal
impairment.
Hepatic impairment: No dose adjustment for Dexlansoprazole is necessary for patients with mild hepatic impairment. A maximum daily dose of Dexlansoprazole 30 mg should be considered for patients with moderate hepatic impairment.
","There have been no reports of a significant overdose of Dexlansoprazole. Multiple doses of Dexlansoprazole 120 mg and a single dose of Dexlansoprazole 300 mg did not result in death or other severe adverse events.
",,,"Store below 30°C temperature & in a dry place, protected from light. Keep all medicines out of reach of children.
",13
+343,Dexketoprofen,dexketoprofen-343,https://medex.com.bd/attachments/i4QJewqooXLwxhkycHs5FrVluYga2T/dexketoprofen-prescribing-information,Drugs for Osteoarthritis,Rheumatic disorders,"Symptomatic treatment of pain and inflammation of mild or moderate intensity, such as musculo-skeletal pain, menstrual pain, & dental pain
","Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Dexketoprofen is the S(+)-enantiomer of Ketoprofen and is responsible for the analgesic and anti-inflammatory activity of Ketoprofen. The inactive R(-)-enantiomer does not contribute to the therapeutic properties of Ketoprofen but adds to the metabolic load. Dexketoprofen has been formulated as a trometamol salt. Its high solubility in water means a rapid absorption through the gut wall which results in a more rapid onset of action than Ketoprofen. Peak plasma concentrations are attained more quickly than other widely used analgesics with an onset of action of 30 minutes. Dexketoprofen trometamol, given as a tablet, is rapidly absorbed, with a time to maximum plasma concentration (tmax) of between 0.25 and 0.75 hours, whereas the tmax for the S-enantiomer after the racemic drug, administered as tablets or capsules prepared with the free acid, is between 0.5 and 3 hours. Peak plasma concentrations of 1.4 and 3.1 mg/L are reached after administration of Dexketoprofen trometamol 12.5 and 25 mg, respectively. From 70 to 80% of the administered dose is recovered in the urine during the first 12 hours, mainly as the acyl-glucuronoconjugated parent drug. No R(-)-Ketoprofen is found in the urine after administration of Dexketoprofen [S(+)-Ketoprofen], confirming the absence of bioinversion of the S(+)-enantiomer in humans. The anti-inflammatory potency of Dexketoprofen was always equivalent to that demonstrated by twice the dose of Ketoprofen.
","The dose of Dexketoprofen 25 mg tablets depends on the type, severity, and duration of pain. The recommended dose is generally 1 tablet every 8 hours, with no more than 3 tablets daily. The elderly and patients with renal or hepatic impairment should start treatment with a total daily dose of no more than 2 tablets. Normally it is recommended to take the tablets with food. In the case of acute pain, it is recommended that tablets be taken at least 30 minutes before meals. Dexketoprofen is not recommended for children.
",,"Any of the following drugs cannot be used at the same time while taking Dexketoprofen. Other non-steroidal anti-inflammatory drugs, anticoagulant medicines; lithium; methotrexate; hydantoins (a type of medicine used for epilepsy) or some antibiotics of sulphonamide type (e.g. sulfamethoxazole); medications used to treat high blood pressure (ACE inhibitors, diuretics and beta-blockers); pentoxifylline; zidovudine; cyclosporine or tacrolimus; some oral medicines for diabetes (sulphonylureas); thrombolytic medicines; probenecid; cardiac glycosides; mifepristone; and quinolone antibiotics.
","Dexketoprofen tablets are not recommended to use in patients who are allergic to this product or aspirin or other non-steroidal anti-inflammatory medicines; who have suffered attacks of asthma, bronchospasm, acute rhinitis, nasal polyps, urticaria, angioedema (swollen face, eyes, lips, or tongue, or difficulty in breathing) after taking aspirin or other non-steroidal anti-inflammatory medicines; who have or previously suffered from a peptic ulcer or chronic gastro-intestinal disorders; who had previously gastro-intestinal haemorrhage (bleeding); who have suffered bronchial asthma; who have severe heart failure, moderate to severe renal dysfunction or severely impaired hepatic function; who have a bleeding disorder, a blood clotting disorder or are taking an anticoagulant; and who are pregnant or breast-feeding.
","As with all medicines, Dexketoprofen 25 mg tablets may cause some unwanted effects in some patients. These are described below and are characteristic of non-steroidal antiinflammatory drugs:
+
+- Common (1-10%): nausea, vomiting, diarrhoea, stomach pain or heartburn.
+- Uncommon (0.1-1%): sleep disorders, nervousness, headache, dizziness, vertigo, palpitations, constipation, dry mouth, flatulence, skin rash, fatigue, hot flushes, shivering, general malaise.
+- Rare (0.01 0.1%): stomach ulceration, gastric haemorrhage or perforation; pins and needles, high blood pressure, water retention, slowed breathing rate, hepatic enzymes increased, increased sweating.
+- Very rare/isolated cases (<0.01%): blurred vision, ringing in the ear, low blood pressure, haematological reactions, hepatic or renal damage, dermatological and photosensitivity reactions, bronchospasm or anaphylaxis.
+- In patients with systemic lupus erythematosus or mixed connective tissue disease, antiinflammatory medicines may rarely cause isolated cases of fever, headache and rigidity of the nape (back of the neck).
+
","The use of Dexketoprofen tablets during pregnancy or breast-feeding is not recommended.
","Precaution should be exercised during using Dexketoprofen tablets in patient who are allergic to any other NSAIDs; who have kidney disease, liver disease, heart disease or fluid retention conditions; and who have blood disorder, systemic lupus erythematosus or mixed connective tissue disease.
","Should not be given to children.
",,,,"Store at a cool & dry place protected from light and moisture. Keep out of reach of children.
",11
+342,Dexibuprofen,dexibuprofen-342,https://medex.com.bd/attachments/g9dDT4U1Uev4xiztze9dYlACkl1xEI/dexibuprofen-tablets-prescribing-information,Drugs for Osteoarthritis,Rheumatic disorders,"Dexibuprofen is indicated in-
+
+- The relief of sign and symptoms of osteoarthritis.
+- Indicated in rheumatoidal disorders such as osseous rheumatism, ankylosing spondilitis, juvenile arthritis, muscular rheumatism, degenerative joint diseases
+- Acute symptomatic treatment of painful menstruation (primary dysmenorrhoea)
... Read more
Dexibuprofen is indicated in-
+
+- The relief of sign and symptoms of osteoarthritis.
+- Indicated in rheumatoidal disorders such as osseous rheumatism, ankylosing spondilitis, juvenile arthritis, muscular rheumatism, degenerative joint diseases
+- Acute symptomatic treatment of painful menstruation (primary dysmenorrhoea)
+- Common headache and fever
+- Symptomatic treatment of mild to moderate pain, such as muscle pain, headache and dental pain
+- As an adjuvant with common cold and influenza associated with headache.
+
","Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Dexibuprofen (S (+)-ibuprofen) is considered as the pharmacologically active enantiomer of racemic ibuprofen. Like racemic ibuprofen, Dexibuprofen is a non-steroidal anti-inflammatory drug with analgesic action. Like ibuprofen, Dexibuprofen acts by inhibiting prostaglandin synthesis.
Pharmacokinetics: Dexibuprofen is absorbed primarily from the small intestine. After metabolic transformation in the liver (hydroxylation, carboxylation) the pharmacologically inactive metabolites are completely excreted, mainly by the kidneys (90%), but also in the bile. The elimination half-life is 1.8-3.5 hours; the plasma protein binding is about 99%. Maximum plasma levels are reached about 2 hours after oral administration. The administration of dexibuprofen with a meal delays the time to reach maximum concentrations (from 2.1 hours after fasting conditions to 2.8 hours after non-fasting conditions) and decreases the maximum plasma concentrations (from 20.6 to 18.1 mcg/ml, which is of no clinical relevance), but has no effect on the extent of absorption.
","The dosage must be adjusted to the seriousness of the syndrome and the complaints of the patient. During chronic pain, the dosage must be adapted to the lowest effective dose.
The recommended dosage: 600-900 mg Dexibuprofen per day, at 2-3 divided doses. The dosage can be raised temporarily up to 1200 mg Dexibuprofen per day in patients with acute disorders or exacerbations. The maximum daily dose is 1200 mg.
At dysmenorrhea: A dosage of 600 up to 900 mg Dexibuprofen per day, at a divided dose.
",,"The reported drug interactions of Dexibuprofen are similar to that of racemic mixture of ibuprofen. Drug interactions is noticed with simultaneous use of anticoagulant, hydantoine and sulfonamide, ticlopidine, lithium, other NSAID's, ACE inhibitors, beta blockers, cyclosporine, tacrolimus, corticosteroids, digoxin, methotrexate, pentoxyfiline, phenytoine, probenecid, sulfinpyrazon, sulfonylurea, thiazide and thiazide type diuretics, and zidovudine.
","Dexibuprofen is contraindicated in patients with previous history of hypersensitivity to Dexibuprofen, or another NSAID, or any other component of the product. Patients, who experience attack of asthma, arouse bronchospasm, acute rhinitis, urticaria or edema after use of similar drugs (e.g. aspirin or other NSAID's). It is also contraindicated in patients with active or suspected hemorrhage, Crohn's disease or ulcerative colitis, patients with serious heart diseases, kidney function impairment (GFR <30ml/min), and liver function impairment.
","Clinical experience has shown that adverse effects of Dexibuprofen are similar to those of racemic ibuprofen. Common side-effects are dyspepsia, diarrhea, fatigue, and headache, nausea, vomiting, abdominal pain, hypersensitivity reactions - bleeding, ulcer.
","Pregnancy: Although no teratogennic impact has been observed in the animal-experimental research with dexibuprofen or ibuprofen, the use should be avoided during the pregnancy. However, animal reproduction studies are not always predictive of human response. Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during late pregnancy should be avoided.
Lactation: Studies at people have shown that racimic ibuprofen proceed in small to negligible degree in mother milk. So, Dexibuprofen should be used with cautions in nursing mothers.
","Dexibuprofen should be used with particular caution in patients with bronchial asthma or other chronic diseases of the pulmonary tract as well as in persons prone to allergy. The drug should be used in patients with hepatic, renal or cardiac insufficiency and with hypertension not responding to any treatment. Consultation with a doctor is recommended for patients with systemic lupus or with other autoimmunological disease before beginning therapy using the drug. Dexibuprofen should be used with extreme cautions in active and suspected hemorrhagic conditions such as gastro-duodenal ulcers, ulcerative colitis, Crohn's disease, alcoholism. Allergic reactions to the drug may appear even for the first-time user and in such case, it should immediately be stopped.
","Hepatic impairment: Patients with mild to moderate liver function impairments must start with low amounts, and must closely be monitored. Dexibuprofen should not be used in patients with serious liver function impairments.
Renal impairment: The start amount must be reduced at patients with mild to moderate kidney function impairments. Dexibuprofen cannot be used patients with serious kidney function impairments.
Children Dose: Although Dexibuprofen is not licensed for use in children under 18 years of age in the UK, some countries permit such use. For example, in Switzerland, Dexibuprofen has been given to children aged 6 years and over at a dose of 10 to 15 mg/kg daily in 2-4 divided doses.
For elderly people: Lowest effective dose is recommended. The dosage can be raised to adult dosage if well tolerated.
","Dexibuprofen has low acute toxicities. Symptoms of toxicity occur at doses between 80 and 100 mg/kg body weight. Mild symptoms are abdominal pain, nausea, vomiting, lethargy, headache, tinnitus and ataxia. Moderate to serious symptoms, such as flatulence, hypotension, hypothermia, metabolic acidosis, reduced kidney function, coma, and apnoea. The treatment must be symptomatic: there is no specific antidote. In case of large quantities of Dexibuprofen, activated charcoal should be administered. Vomiting can be induced only when life-threatening quantities of the substance ingested and the procedure can be carried out within 60 minutes after ingestion. Dialysis and hemodialysis are of little value as Dexibuprofen binds strongly to plasma protein.
",,,"Do not store above 30°C. Keep away from light and out of the reach of children
",12
+341,Dexamethasone + Tobramycin,dexamethasone-tobramycin-341,https://medex.com.bd/attachments/fYhsYAOZhdpfNik8JMAhw6tGS2liW2/dexamethasone-tobramycin-prescribing-information,Ophthalmic steroid - antibiotic combined preparations,Pink eye,"This sterile Eye Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.
","Ophthalmic steroid - antibiotic combined preparations
","Like other amino-glycosides, the bactericidal activity of Tobramycin is accomplished by specific inhibition of normal protein synthesis in susceptible bacteria, but at the present time, very little is known about this action. It is thought that inhibition of protein synthesis is due to an action on ribosome that causes bacterial misreading of messenger RNA. The action of Dexamethasone is to inhibit the phospholipase A2, the first step in prostaglandin synthesis. Also Dexamethasone inhibits the chemo-tactic infiltration of neutrophils into the site of inflammation. The result is that its anti-inflammatory activity is 25 times greater and its overall therapeutic effectiveness 8-10 times greater than that of hydrocortisone.
","Insert 1 drop into the conjunctival sac 3-5 times per day. During the initial 24 to 48 hours, the dosage may be increased to 1 drop every 2 hours.
",,"No specific interaction studies were performed with this combination eye drops. In case of concomitant therapy with other topical ophthalmic medicines, an interval of 10 minutes should be allowed between successive applications.
","Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella and other viral disease of the cornea and conjunctiva. Mycobacterial infections of the eye caused by, but not limited to, acid-fast bacilli such as Mycobacterium tuberculosis, Mycobacterium leprae, or Mycobacterium avium. Fungal diseases of ocular structures. Untreated purulent infection of the eye. Hypersensitivity to any component of the medication.
","The most frequent side effects to topical ocular Tobramycin are localized ocular toxicity and hypersensitivity, including lid itching and swelling and conjuntival erythema. The reactions due to the steroid component are elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsule cataract formation.
","Safety for use during pregnancy and lactation in humans has not been established
","Shake the bottle well before use. To prevent contamination do not touch the tip of the bottle to affected eye, eyelid or any surface of of the affected eye. Keep the bottle tightly closed after use.
","Use in paediatric: Safety and effectiveness in paediatric patients below 2 years have not been established.
","Overdose of this eye drops may be flushed from the eye(s) with lukewarm tap water.
",,,"Store at room temperature. Close the bottle immediately after use. Do not use for longer than one month after opening the bottle.
",12
+340,Dexamethasone + Neomycin Sulphate + Polymyxin B Sulphate,dexamethasone-neomycin-sulphate-polymyxin-b-sulphate-340,https://medex.com.bd/attachments/IRDOjiU2irGRTs5DFCw7HojrfVreZW/dexamethasone-neomycin-sulphate-polymyxin-b-sulphate-prescribing-information,Ophthalmic steroid - antibiotic combined preparations,Ocular infections,"This is indicated in ocular inflammation when concurrent use of an antimicrobial is judged necessary.
","Ophthalmic steroid - antibiotic combined preparations
","Dexamethasone (Corticosteroids) suppress inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroid may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case. The anti-infective component in the combination is included to provide action against specific organisms susceptible to it.
Neomycin Sulphate is considered active against the following microorganisms: Staphylococcus aureus, Corynebacterium diphtheriae, Streptococcus Viridans, Escherichia coli,Klebsiella pneumoniae, Proteus vulgaris, Aerobacter aerogenes, and Haemophilus influenzae.
Polymyxin B Sulphate is considered active against the following microorganism: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Koch-Weeks bacillus.
When a decision to administer both a corticosteroid and an antimicrobial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered, plus assured compatibility of ingredients when both types of drugs are in the same formulation and, particularly, that the correct volume of drug is delivered and retained.
","Eye drops: One drop topically into the conjunctival sac(s). In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily.
Eye ointment: It should be applied thinly and evenly to the conjunctival sac(s) at night (if eye drops used during the day) or 3-4 times daily (if eye ointment used alone).
",,"There are no known drug interactions and none well documented.
","Epithelial herpes simplex keratitis (dentritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Hypersensitivity to a component of the medication (Hypersensitivity to the antibiotic component occurs at a higher rate than other component). The use of these combinations is always contraindicated after uncomplicated removal of a corneal foreign body.
","Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available. Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. The reactions due to the steroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage, posterior sub-capsular cataract formation and delayed wound healing.
","Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Lactation: Unknown if excreted in breast milk; minimal systemic absorption with ophthalmic administration
","Prolonged use may cause glaucoma, damage to the optic nerve, defects in visual acuity and fields of vision, posterior subcapsular cataract formation and increased risk of secondary ocular infections. Increased risk of perforations in diseases which can cause thinning of the cornea or sclera. Corticosteroids may mask infection or worsen existing infections in acute purulent conditions of the eye. Regular monitoring of the intraocular pressure is recommended if product is used for 10 days. Long term application of topical corticosteroids may also increase the risk of ocular fungal infections. Neomycin sulfate may cause cutaneous sensitisation. Pregnancy and lactation.
",,,,,,9
+238,Dexamethasone + Chloramphenicol,dexamethasone-chloramphenicol-238,https://medex.com.bd/attachments/9TQfYaNQj7gTZD4qa03jiNHwnESsSx/dexamethasone-chloramphenicol-prescribing-information,Ophthalmic steroid - antibiotic combined preparations,Post-herpetic keratitis,"Eye: This combination is indicated in acute purulent conjunctivitis, fresh inflammation of the superficial and deeper corneal layers and corneal ulceration. It is also used in keratitis disciformis and the more deep-seated forms of post-herpetic keratitis, allergic conjunctivitis, allergic ... Read more
Eye: This combination is indicated in acute purulent conjunctivitis, fresh inflammation of the superficial and deeper corneal layers and corneal ulceration. It is also used in keratitis disciformis and the more deep-seated forms of post-herpetic keratitis, allergic conjunctivitis, allergic blepharitis, acute and chronic iritis, chronic anterior uveitis and corneal injury from chemical radiation or thermal burns, or penetration of foreign bodies. The combination is used in steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or arisk of bacterial ocular infection exists. The combination can also be used for post-operative inflammation and any other ocular inflammation associated with infection.
Ear: This combination is indicated in otitis externa, otitis media and chronic suppurative otitis media.
","Ophthalmic steroid - antibiotic combined preparations
","Dexamethasone is a glucocorticoid. It has an anti-inflammatory and anti-allergic action. It is used topically in the treatment of inflammatory conditions of the anterior segment of the eye. Dexamethasone is absorbed rapidly after oral administration with a half-life of about 190 minutes. Sufficient absorption may occur after topical application to the skin and eye to produce systemic effects.
Chloramphenicol is a broad spectrum bacteriostatic antibiotic active against a wide variety of gram-negative and gram-positive organisms. Chloramphenicol exerts its antibacterial effect by binding to bacterial ribosomes and inhibiting bacterial protein synthesis at an early stage
","Eye:
+
+- Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is 1 to 2 drops instilled into the conjunctival sac (s) every 2 hours for 2 days and 1 or 2 drops every 4 hours for the next 5(five days) while awake.
+- Corneal Ulcers: The recommended dosage regimen for the treatment of comeal ulcer is 2 drops in the affected eye (s) every 15 minutes for the first 6 hours then 2 drops into the affected eye(s) every 30 minutes for the remainder of first day. On the second day, instill 2 drops in the affected eye (s) hourly. On the 3 to 14 days, place 2 drops in the affected eye (s) every 4 hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
+
+
Ear: For all infections, 2 to 3 drops every 2 to 3 hours initially. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.
",,"If Chloramphenicol is absorbed from eye when taking anticoagulants e.g. warfarin, there may be an increase in the effect of this medicine. Action of Chloramphenicol will be inhibited if given simultaneously with Phenobarbital. The therapeutic efficacy of Dexamethasone may be reduced with the concomitant administration of phenytoin, phenobarbitone, ephedrine and rifampicin.
","The combination is contraindicated in epithelial herpes simplex cornealis, fungal, viral, tuberculous and other infections of the eye and in glaucoma. Myelosuppression during previous exposure to Chloramphenicol. Hypersensitivity to Chloramphenicol & Dexamethasone Phosphate or to any other ingredients of the preparations.
","Adverse reactions seen with Chloramphenicol are transient ocular burning or discomfort and other reported reactions include stinging, redness, itching, conjunctivitis, foreign body sensation, photophobia, blurred vision, dryness and eye pain. Allergic sensitization may occur with the local use of Chloramphenicol. Elevation of intraocular pressure with possible development of glaucoma, infrequent optic nerve damage and posterior subcapsular cataract formation.
","There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Chloramphenicol and Dexamethasone ophthalmic solution is administered to a nursing mother.
","The possibility of persistent fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Prolonged use of steroids containing products may result in posterior subcapsular cataract formation and glaucoma with optic nerve damage. Intraocular pressure monitoring is needed. Prolonged use of antibiotics may result in the overgrowth of non-susceptible organisms, including fungi. If new infections appear during treatment, the drug should be discontinued and alternative therapy should be instituted.
",,,,,"Keep in a cool and dry place, away from light & keep out of the reach of children. Do not use after 30 days of first opening.
",10
+337,Dexamethasone (Ophthalmic),dexamethasone-ophthalmic-337,https://medex.com.bd/attachments/ycNBMb2BwSaUXXLYVhS1jDayphAdlB/dexamethasone-ophthalmic-prescribing-information,,,"Eye: Dexamethasone Phosphate is indicated for treatment of steroid responsive inflammatory conditions of the conjunctiva, cornea and anterior segment of the eye such as: anterior uveitis, iritis, cyclitis, allergic and vernal conjunctivitis, herpes zoster keratitis, superficial punctate ... Read more
Eye: Dexamethasone Phosphate is indicated for treatment of steroid responsive inflammatory conditions of the conjunctiva, cornea and anterior segment of the eye such as: anterior uveitis, iritis, cyclitis, allergic and vernal conjunctivitis, herpes zoster keratitis, superficial punctate keratitis and non-specific superficial keratitis.
Also indicated for the treatment of corneal injury from chemical, radiation or thermal burns or following penetration by foreign bodies. Indicated for post operative use to reduce inflammatory reactions and suppress graft reaction.
Ear: Indicated in the steroid responsive inflammatory conditions of the external auditory meatus, such as allergic otitis externa, selected purulent and non-purulent infective otitis externa.
",,"Dexamethasone is a synthetic glucocorticoid which decreases inflammation by inhibiting the migration of leukocytes and reversal of increased capillary permeability. It suppresses normal immune response.
","Eye:
+
+- As 0.1% drop: The frequency of instillation of drops and the duration of treatment will vary depending upon the severity of the underlying condition and the response to treatment. Severe inflammations require one to two drops instilled into the eye every thirty to sixty minutes until a satisfactory response occurs. Subconjunctival or systemic steroid therapy should be considered if there is no response. When a favourable response has been observed reduce the dosage towards one drop every four hours.
+- As 0.05% ointment: Apply 0.5-1 inch ribbon of ointment into the conjunctival sac(s) up to 4 times daily. Reduce to once daily dosing once conditon has improved.
+
+
Ear: Instill two or three drops to the ear at two or three hour interval. The frequency of dosage and duration of the treatment may vary with the type of lesion and severity.
",,"None relevant to topical use.
","Epithelial herpes simplex keratitis (dendritic keratitis), acute infections stages of vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva, Mycobacterial infection of the eye, Fungal diseases of ocular or auricular structures, perforation of a drum membrane. Hypersensitivity to any ingredient of this product.
","Glaucoma with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, perforation of the globe. Rarely, stinging and burning may occur.
","Pregnancy category C. There is no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: Caution should be exercised when Dexamethasone ophthalmic solution is administered to a nursing woman.
","The possibility of persistent fungal infections of the cornea should be considered after prolonged corticosteroid dosing. There have been reports of bacterial keratitis associated with the use of multiple dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.
","Pediatric Use: Safety and efficacy in pediatric patients below the age of 18 have not been established.
","Long-term intensive topical use may lead to systemic effects. Oral ingestion of the contents of the bottle (up to 10 ml) is unlikely to lead to any serious adverse effects.
",,,"Store below 30° C in a cool and dry place protected from light. Keep out of reach of children. Do not touch the dropper tip to surfaces since this may contaminate the solution. Do not use after 30 days of first opening.
",11
+335,Dexamethasone,dexamethasone-335,https://medex.com.bd/attachments/5bc7h0O7Jwgu8jSYEV3Gqqdv9ImIRj/dexamethasone-injection-prescribing-information,,,"Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis and serum sickness.
Collagen disease ... Read more
Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis and serum sickness.
Collagen disease: Like lupus erythematosus, rheumatoid arthritis etc.
Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus and severe erythema multiforme (Stevens-Johnson syndrome).
Endocrine disorders: Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, hypercalcemia associated with cancer and nonsuppurative thyroiditis.
Gastrointestinal diseases: Regional enteritis and ulcerative colitis.
Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults and selected cases of secondary thrombocytopenia.
Neoplastic diseases: Leukemias and lymphomas.
Nervous system: Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury.
Ophthalmic diseases: Temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
Renal diseases: To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.
Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
Miscellaneous: Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.
",,"Dexamethasone is a synthetic glucocorticoid which decreases inflammation by inhibiting the migration of leukocytes and reversal of increased capillary permeability. It suppresses normal immune response.
","In general, glucocorticoid dosage depends on the severity of the condition and the response of the patient. If no favourable response is noted within a couple of days, continuation of glucocorticoid therapy is undesirable. In chronic conditions requiring long-term therapy the lowest dosage that provides adequate, but not necessarily complete, relief should be used.
For tablet:
+
+- In adult patients, daily oral dosages vary from 1 mg to 10 mg and in children from 0.03-0.20 mg/kg body weight,according to the individual response.
+- In some patients higher dosages may be temporarily required,to control the disease. As soon as circumstances permit,dosage should be decreased.
+- For a short dexamethasone suppression test 1 mg dexamethasone is given at 11 p.m. and plasmacortisol measured the next morning.
+- Patients who do not show a decrease in cortisol can be exposed to a longer test: 0.5 mg dexamethasone is given at 6-hour intervals
+- for 48 hours followed by 2 mg every 6 hours for a further 48 hours. 24-hour urine collections are made before, during and at the end of the test for the determination of 17 alpha-hydroxycorticoids.
+
+For injection:
+
+- Dexamethasone can be given by intravenous (IV), intramuscular (IM) or local injection. Dexamethasone injections can also be diluted with an infusion fluid or be injected directly into the infusion line.
+- Intravenous injections of massive doses should be given slowly, over a period of several minutes.
+- Intramuscular administration should be given by deep intramuscular injection,to prevent atrophy of the subcutaneous adipose tissues.
+- Intra-articular injections should be given under strictly aseptic conditions as glucocorticoids decrease the resistance to infection. When diluted with these infusion fluids, Dexamethasone will keep its potency for at least 24 hours (at room temperature and in daylight conditions). As infusion fluids, Sodium chloride 0.9%, Anhydrous glucose 5%, Invert sugar 10%, Sorbitol 5%, Ringer's solution, Hartman's solution (Ringer-lactate) etc.can be used.
+- The dosage of Dexamethasone depends on the severity of the condition and the response of the patient.
+- For systemic therapy in adults, daily doses of 0.05-0.20 mg/kg body weight are usually sufficient. For emergencies (e.g. anaphylaxis, acute severe asthma, cerebral edema) substantially higher doses are required. An initial dose of 10-20 mg IV is followed by 6 mg IV or IM every 6 hours,until a satisfactory result has been obtained. Thereafter the dosage has to be tapered off gradually.
+
+For local therapy, the following doses are recommended:
+
+- Intra-articularly: 2-4 mg in large and 0.8-1 mg in small joints
+- Intrabursally: 2-4 mg;in tendon sheaths:0.4-1 mg
+- The frequency of these injections may vary from every 3-5 days to every 2-3 weeks
+
",,"
+- Diuretics and/or cardiac glycosides, since potassium loss may be enhanced.This is a particular risk in patients using cardiac glycosides; since hypokalaemia increases the toxicity of these drugs.
+- Antidiabetics, since glucocorticoids may impair glucose tolerance, thereby increasing the need for antidiabetic drugs.
+- Non-steroidal anti-inflammatory drugs, since the incidence and/or severity of gastro-intestinal ulceration may increase.
+- Oral anti-coagulants since glucocorticoids may alter the need for these drugs.
+- Glucocorticoids may be less effective when used concomitantly with liver enzyme inducing drugs,such as rifampicin, ephedrine, barbiturates, phenytoin and primidone.
+- If patients undergoing long-term therapy with glucocorticoids are concomitantly given salicylates, any reduction in glucocorticoid dosage should be made with caution, since salicylate intoxication has been reported in such cases.
+- Antacids;especially those containing magnesium trisilicate,have been reported to impair the gastro-intestinal absorption of glucocorticoids. Therefore, doses of one agent should be spaced as far as possible from the other.
+
","
+- Gastric and duodenal ulcers.
+- Systemic and ophthalmic fungal infections.
+- Viral infections, e.g. varicella and herpes genitalis infections. Viral infections of the eye.
+- Glaucoma.
+- Hypersensitivity to corticosteroids
+
","The following adverse reactions have been associated with prolonged systemic glucocorticoid therapy.
Endocrine and metabolic disturbances: Cushing-like syndrome, hirsutism, menstrual irregularities, premature epiphyseal closure, secondary adrenocortical and pituitary unresponsiveness, decreased glucose tolerance, negative nitrogen and calcium balance.
Fluid and electrolyte disturbances: Sodium and fluid retention, hypertension, potassium loss, hypokalaemic alkalosis.
Musculo-skeletal effects: Myopathy, abdominal distension, osteoporosis, aseptic necrosis of femoral and humeral heads.
Gastro-intestinal effects: Gastric and duodenal ulceration, perforation and haemorrhage.
Dermatological effects: Impaired wound healing, skin atrophy, striae, petechiae and ecchymoses, bruising, facial erythema, increased sweating, acne.
Central Nervous System effects: Psychic disturbances ranging from euphoria to frank psychotic manifestations,convulsions,in children pseudotumor cerebri (benign intracranial hypertension) with vomiting and papilloedema.
Ophthalmic effects: Glaucoma, increased intraocular pressure, posterior subcapsular cataracts.
Immunosuppressive effects: Increased susceptibility to infections, decreased responsiveness to vaccination and skin tests.
","Pregnancy Category C.There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Glucocorticoids appear in breast milk.Mothers taking high dosages of corticosteroids should be advised not to breast-feed
","General: The lowest possible dose of corticosteroids should be used to control the condition under treatment.The reduction should be gradual.
Cardio-renal: These agents should be used with caution in patients with congestive heart failure,hypertension, or renal insufficiency.
Endocrine: Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage.
Gastrointestinal: Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.
Musculoskeletal: Special consideration should be given to patients at increased risk of osteoporosis (e.g.,postmenopausal women) before initiating corticosteroid therapy.
Neuro-psychiatric: An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with myasthenia gravis or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). Psychic derangements may appear ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations.
","In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose.
","Overdosage is unlikely, however, treatment of overdosage is by supportive and symptomatic therapy
",,,"Tablet: Store in a cool & dry place, protected from light & moisture.
Injection: Store below 30° C, protected from light.Do not freeze. Keep medicines out of the reach of children
",11
+334,Desvenlafaxine,desvenlafaxine-334,https://medex.com.bd/attachments/su8R68HpfJccIdfM0BodnqpVDrB0SQ/desvenlafaxine-prescribing-information,Serotonin-norepinephrine reuptake inhibitor (SNRI),Depression,"Desvenlafaxine, a serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder (MDD). The efficacy of Desvenlafaxine has been established in four short-term (8-week, placebo-controlled studies) and two maintenance studies in adult outpatients who met DSM-IV criteria for major depressive disorder.
","Serotonin-norepinephrine reuptake inhibitor (SNRI)
","Desvenlafaxine is the principal active metabolite of venlafaxine. The exact mechanism is unknown, but is thought to be related to the potentiation of serotonin and norepinephrine in the CNS, through inhibition of their reuptake.
","The recommended dose for Desvenlafaxine is 50 mg once daily, with or without food. The 50 mg dose is both a starting dose and the therapeutic dose. Desvenlafaxine should be taken at approximately the same time each day. Tablets must be swallowed whole with fluid and not divided, crushed, chewed, or dissolved.
In clinical studies, doses of 10 mg to 400 mg per day were studied. In clinical studies, doses of 50 mg to 400 mg per day were shown to be effective, although no additional benefit was demonstrated at doses greater than 50 mg per day and adverse reactions and discontinuations were more frequent at higher doses.
The 25 mg per day dose is intended for a gradual reduction in dose when discontinuing treatment. When discontinuing therapy, gradual dose reduction is recommended whenever possible to minimize discontinuation symptoms
",,"Increased risk of bleeding with aspirin or other NSAIDs, warfarin and other anticoagulants.
","Concurrent use or within 14 days of discontinuing MAOIs (e.g. linezolid, IV methylene blue). Initiation of MAOI at least 7 days after discontinuing desvenlafaxine.
","Suicidal thinking/ behaviour, HTN, mydriasis, seizure, hyponatraemia, interstitial lung disease and eosinophilic pneumonia; nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, sexual function disorders in males (e.g. anorgasmia, decreased libido, abnormal orgasm, delayed ejaculation, erectile dysfunction, ejaculation disorder, ejaculation failure, sexual dysfunction).
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Patient with pre-existing HTN or other conditions that may be compromised by increased BP, raised intraocular pressure, personal or family history of mania or hypomania; CV, cerebrovascular or lipid metabolism disorders; seizure disorder. Avoid abrupt withdrawal. Renal and moderate to severe hepatic impairment. Pregnancy and lactation.
","Hepatic impairment (Moderate to severe): 50 mg daily. Max: 100 mg once daily.
Renal Impairment:
+
+- CrCl <30 or ESRD: 25 mg daily or 50 mg every other day. Supplemental doses should not be given after dialysis.
+- CrCl (30-50): Max 50 mg once daily.
+
",,,,"Store between 20-25° C.
",11
+1402,Desoximetasone,desoximetasone-1402,https://medex.com.bd/attachments/LTebd2zVPkssrZAenMMXBGlvqefSeH/desoximetasone-prescribing-information,Other Topical corticosteroids,Anti - inflammatory treatment,"Desoximetasone Emollient Cream indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-inflammatory and pruritic manifestations of corticosteroid
","Other Topical corticosteroids
","The precise mechanism of the antiinflammatory activity of topical steroids in the treatment of steroid-responsive dermatoses, in general, is uncertain. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. This is achieved first by the drug binding to the glucocorticoid receptors which then translocates into the nucleus and binds to DNA causing various activations and repressions of genes. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
","Apply a thin film of Desoximetasone Emollient Cream to the affected skin areas twice daily. Rub in gently
",,,"Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
",,"Pregnancy Category C
",,,"Topically applied corticostero systemic effects
",,,,7
+333,Desonide,desonide-333,https://medex.com.bd/attachments/u4SqJqGqkrYbeQ32QbyjXHv534MbRX/desonide-prescribing-information,Other Topical corticosteroids,Atopic dermatitis,"Desonide gel is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.
","Other Topical corticosteroids
","Desonide gel contains Desonide which is a synthetic nonfluorinated corticosteroid for topical dermatologic use. Topical corticosteroids have anti-inflammatory, antipruritic and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. Corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.
","Desonide gel is for external use only. Gel should be applied as a thin layer to the affected areas two times daily and rubbed in gently. Therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, treatment should be discontinued and Desonide gel should not be used with occlusive dressings.
Pediatric use: The safety and effectiveness of Desonide gel in pediatric patients less than 3 months of age have not been evaluated, and therefore its use in this age group is not recommended.
",,,"Desonide gel is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
","The most common local side effects are burning, rash and pruritus at the application site. The following additional local side effects have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, secondary infection, skin atrophy, striae, and miliaria.
","Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Therefore, Desonide gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Caution should be exercised when Desonide gel is administered to a nursing woman.
","Desonide gel is to be used as directed by the physician. It is for external use only and avoid contact with the eyes. It should not be used on the underarm or groin areas of pediatric patients. If irritation develops, Desonide gel should be discontinued and appropriate therapy instituted. Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. If a favorable response does not occur promptly, use of Desonide gel should be discontinued until the infection has been adequately controlled.
",,"Topically applied Desonide gel can be absorbed in sufficient amounts to produce systemic effects.
",,,"Store in a cool & dry place. Protect from light.
",10
+331,Desogestrel,desogestrel-331,https://medex.com.bd/attachments/YjGdiBX3yPq6uATtEiAt1F1tRDZ5X5/desogestrel-prescribing-information,Oral Contraceptive preparations,Oral contraceptives,"Desogestrel is used to provide contraceptive efficacy in women who want to prevent pregnancy. Desogestrel has proved to be highly efficacious as a contraceptive pill and is an alternative for women who have a weak tolerance levels for the estrogen hormones or who are lactating or breast feeding.
","Oral Contraceptive preparations
",,"One tablet at the same time each day, taken continuously without a break. Tablets should be taken within 3 hours of the same time each day.
When and how to take the tablets: Each strip of Desogestrel contains 28 tablets. Arrows are printed on the front side of the strip, between the tablets. If you turn the strip over, next to each tablet is printed the day of the week each tablet should be taken. Take your tablet at about the same time each day. Swallow each tablet whole with water. Each time you start a new strip of Desogestrel; take a tablet in the top row. For example if you start on Wednesday, you should take the tablet from the top row marked that particular day. You should continue to take one tablet a day until the strip is empty, always follow the direction indicated by the arrows. In this way you can easily check whether you have taken your daily tablet. You may have some bleeding during the use of Desogestrel but you must continue to take your tablets as normal. When a strip is empty, you must start with a new pack of Desogestrel on the next day without interruption and without waiting for a bleed. You can stop taking Desogestrel whenever you want. From the day you stop, you are no longer protected against pregnancy.
Starting first pack of Desogestrel: If you are not using hormonal contraception at present (or in the past month) wait for your period to begin. On the first day of your period take the first Desogestrel tablet. If you take your first tablet on days 2 to 5 of your period use an additional barrier method of contraception for the first 7 days of tablet taking.
When change from a combined pill: Start Desogestrel on the day after the last active tablet of the combined pill; in this case additional contraceptive precautions are not necessary.
When change from a mini-pill, injection, implant or hormonal IUD: Switch on any day from another mini pill. Start Desogestrel the day an implant or IUD is removed or the day your next injection would be due, additional contraceptive precau-tions are not necessary.
If you have a baby or abortion: Start immediately after first trimester abortion, additional contraceptive precautions are not necessary. After delivery or second trimester abortion, start before periods return. If more then 21 days have elapsed, pregnancy must be ruled out and an additional barrier method of contraception should be used for the first 7 days.
If you forget to take one or more tablets
+
+- If you are more than 12 hours late: Take a tablet as soon as you remember and take the next one at the usual time. This may mean taking two tablets in one day. This is not harmful. (If you have forgotten more than one tablet you don't need to take the earlier missed ones). You are not protected against pregnancy. Continue to take your tablets as usual but you must also use an extra method, such as a condom, for the next seven days. If you are more than 12 hours late taking your tablet and have had sex it is safe to use emergency contraception.
+- If you are less than 12 hours late: Take the tablet as soon as you remember, and take the next tablet at the usual time. The contraceptive action of Desogestrel is maintained. If you missed one or more tablets in the first week of tablet intake and had intercourse in the week before missing the tablets, there is a possibility of becoming pregnant. The more consecutive tablets you have missed, the higher the risk that the contraceptive efficacy is decreased.
+
+
If you vomit or use medical charcoal: If you vomit or use medical charcoal within 3 - 4 hours after taking your Desogestrel tablet, the active ingredient may not have been completely absorbed. Follow the advice for missed tablets.
",,"Enzyme-inducing drugs may result in increased clearance and lead to breakthrough bleeding and contraceptive failure. This may be seen with hydantoins, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, rifabutin, felbamate, ritonavir, griseofulvin and products containing St John's Wort. Reduced absorption of etonogestrel may be seen with medical charcoal.
","Known or suspected pregnancy, active venous thromboembolic disorder, presence or history of severe hepatic disease with current abnormal liver function tests, progestogen dependent tumors, undiagnosed vaginal bleeding, hypersensitivity to ingredients.
","Common: irregular bleeding, amenorrhoea, headache, weight gain, breast pain, nausea, acne, mood changes, decreased libido. Less common: Vaginitis, dysmenorrhoea, ovarian cysts, vomiting, alopecia, fatigue, difficulty wearing contact lenses. Rare: Rash, urticaria, erythema nodosum.
","Not recommended for use during pregnancy. Desogestrel does not affect the production or quality of breast milk. Small amounts of the metabolite etonogestrel are excreted with the milk. Long term follow-up data are not available, however 7 month data do not indicate a risk to the nursing infant
","Epidemiological studies have associated the use of combined OCs with an increased incidence of venous thromboembolism (VTE, deep venous thrombosis and pulmonary embolism). It is unclear whether desogestrel used alone carries the same risk. Discontinue in the event of a thrombosis. Consider stopping prior to long term immobilization due to surgery or illness. Benefit/risk assessment should be made in women with liver cancer. Caution patients with a history of thromboembolic disorders. Patients with diabetes should be carefully monitored. Effects on bone density are unknown.
",,"No serious deleterious effects have been reported from an overdose. Other symptoms may include nausea, vomiting and in young girls, slight vaginal bleeding. Treatment should be symptomatic.
",,,"Store at room temperature (below 30°C). Do not use it after the expiry date stated on the package.
",10
+1794,Desmopressin Acetate,desmopressin-acetate-1794,https://medex.com.bd/attachments/VeU6Bnn5d55VwddBl48PWVLUHReKJ0/desmopressin-acetate-60-mcg-tablet-prescribing-information,Synthetic analogue of ADH,Diabetes insipidus,"Desmopressin Acetate sublingual tablet is indicated for the treatment of-
+
+- Primary Nocturnal Enuresis
+- Nocturia and
+- Central Diabetes Insipidus
+
","Synthetic analogue of ADH
","By mimicking the actions of endogenous ADH, desmopressin acts as a selective agonist of V2 receptors expressed in the renal collecting duct (CD) to increase water re-absorption and reduce urine production. Desmopressin has been shown to be more potent than ADH in increasing plasma levels of factor VIII activity in patients with hemophilia and von Willebrand's disease Type I. Desmopressin demonstrates markedly diminished pressor activity. Desmopressin administered intranasally has an antidiuretic effect about one-tenth that of an equivalent dose administered by injection.
Upon binding of desmopressin to V2 receptors in the basolateral membrane of the cells of the distal tubule and collecting ducts of the nephron, adenylyl cyclase is stimulated. The resulting intracellular cascades in the collecting duct lead to increased rate of insertion of water channels, called aquaporins, into the lumenal membrane and enhanced the permeability of the membrane to water.
","Treatment of diabetes insipidus: Dosage is individual in diabetes insipidus but the total daily sublingual dose normally lies in the range of 120 micrograms to 720 micrograms. A suitable starting dose in adults and children is 60 micrograms three times daily, administered sublingually. This dosage regimen should then be adjusted in accordance with the patient's response. For the majority of patients, the maintenance dose is 60 micrograms to 120 micrograms sublingually three times daily.
Post-hypophysectomy polyuria/polydipsia: The dose of Desmopressin Acetate Melt should be controlled by measurement of urine osmolality.
","Desmopressin Acetate Melt is for sublingual use.
","Substances which are known to induce SIADH e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine and carbamazepine, may cause an additive antidiuretic effect leading to an increased risk of water retention and/or hyponatraemia. NSAIDs may induce water retention and/or hyponatraemia. Concomitant treatment with loperamide may result in a 3-fold increase of desmopressin plasma concentrations, which may lead to an increased risk of water retention and/or hyponatraemia. Although not investigated, other drugs slowing intestinal transport might have the same effect. A standardised 27% fat meal significantly decreased the absorption (rate and extent) of a 0.4mg dose of oral desmopressin tablets. Although it did not significantly affect the pharmacodynamic effect (urine production and osmolality), there is the potential for this to occur at lower doses. If a diminution of effect is noted, then the effect of food should be considered before increasing the dose.
","Desmopressin Acetate Melt is contraindicated in cases of cardiac insufficiency and other conditions requiring treatment with diuretic agents. Before prescribing Desmopressin Acetate Melt, the diagnoses of psychogenic polydipsia and alcohol abuse should be excluded.
","Side-effects include headache, stomach pain and nausea. Isolated cases of allergic skin reactions and more severe general allergic reactions have been reported. Very rare cases of emotional disorders including aggression in children have been reported. Treatment with desmopressin without concomitant reduction of fluid intake may lead to water retention/hyponatraemia with accompanying symptoms of headache, nausea, vomiting, weight gain, decreased serum sodium and in serious cases, convulsions.
","Pregnancy: Data on a limited number (n=53) of exposed pregnancies in women with diabetes insipidus indicate rare cases of malformations in children treated during pregnancy. To date, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women. Blood pressure monitoring is recommended due to the increased risk of pre-eclampsia.
Lactation: Results from analyses of milk from nursing mothers receiving high dose desmopressin (300 micrograms intranasally) indicate that the amounts of desmopressin that may be transferred to the child are considerably less than the amounts required to influence diuresis.
","Care should be taken with patients who have reduced renal function and/or cardiovascular disease. In chronic renal disease the antidiuretic effect of Desmopressin Acetate Melt would be less than normal. Precautions to prevent fluid overload must be taken in:
+
+- conditions characterised by fluid and/or electrolyte imbalance.
+- patients at risk for increased intracranial pressure.
+
",,"An overdose of Desmopressin Acetate Melt leads to a prolonged duration of action with an increased risk of water retention and/or hyponatraemia. Although the treatment of hyponatraemia should be individualised, the following general recommendations can be given. Hyponatraemia is treated by discontinuing the desmopressin treatment, fluid restriction and symptomatic treatment if needed.
",,,"Store in the original package in order to protect from moisture and light.
",12
+365,Difluprednate,difluprednate-365,https://medex.com.bd/attachments/7lZseCDaeB7GcTQ2qTNXupy3MDlrrb/difluprednate-prescribing-information,Ophthalmic Steroid preparations,Ocular inflammation,"Difluprednate is indicated for the treatment of inflammation and pain associated with ocular surgery. It is also indicated for the treatment of uveitis, pseudophakic cystoid macular edema(CME), ocular surface diseases, e.g. blepharitis & corneal inflammation.
","Ophthalmic Steroid preparations
","Corticosteroids inhibit the inflammatory response to a variety of inciting agents and may delay or slow healing. They inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Difluprednate is structurally similar to other corticosteroids.
","For the treatment of inflammation and pain associated with ocular surgery: Instill 1 drop into the conjunctival sac of the affected eye 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period, followed by 2 times daily for a week and then a taper based on the response.
For the treatment of endogenous anterior uveitis: Instill 1 drop into the conjunctival sac of the affected eye 4 times daily for 14 days followed by tapering as clinically indicated.
For blepharitis: Instill 1 drop into the conjunctival sac of the affected eyes 2 times daily for 1 week & then once daily for 1 week.
For pseudophakic cystoid macular edema: Instill 1 drop into the conjunctival sac of the affected eyes 2 times daily.
",,"Specific drug interaction studies have not been conducted with Difluprednate 0.05% ophthalmic emulsion.
","Difluprednate is contraindicated in most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
","Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects; posterior subcapsular cataract formation; secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera. Ocular adverse reactions occurring with Difluprednate included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis for patient with ocular surgery.
","Pregnancy Category C. Difluprednate has been shown to be embryotoxic and teratogenic when administered subcutaneously to rabbits. Since use of Difluprednate during human pregnancy has not been evaluated so Difluprednate should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus. It is not known whether use of Difluprednate passes into breast milk. Caution should be exercised when it is administered to a nursing mothers.
","
+- Prolonged use of corticosteroids may result in glaucoma & posterior subcapsular cataract formation. If this product is used for 10 days or longer, IOP should be monitored.
+- Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.
+- Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application.
+- Do not touch dropper tip to any surface as this may contaminate this preparation.
+
","Pediatric Use: Difluprednate was evaluated in 0 to 3 years of age for the treatment of inflammation following cataract surgery. A similar safety profile was observed in pediatric patients comparing Difluprednate to Prednisolone Acetate ophthalmic suspension 1%.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
","Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.
",,,"Store at room temperature, protect from light and freezing. It is desirable that the contents should not be used more than 1 month after first opening of the bottle.
",12
+1854,Diflorasone Diacetate,diflorasone-diacetate-1854,https://medex.com.bd/attachments/B4OnVmxpvmThxvKT1LawBOQz22yX9P/diflorasone-diacetate-cream-prescribing-information,Other Topical corticosteroids,Pruritic skin conditions,"Diflorasone Diacetate cream & ointment are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
","Other Topical corticosteroids
","Like other topical corticosteroids, Diflorasone Diacetate has anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of the anti-inflammatory activity of the topical corticosteroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
","Apply to the affected areas as a thin film from one to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy should be instituted.
Safety and effectiveness of Diflorasone Diacetate cream & ointment in paediatric patients have not been established. Paediatric patients are at greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids.
",,,"Diflorasone Diacetate is contraindicated in those patients with a history of hypersensitivity to the preparation.
","The following adverse effects have been reported infrequently with topical corticosteroids. These reactions include burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infections, skin atrophy, striae and miliaria.
","Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Therefore caution should be exercised when topical corticosteroids are administered to a nursing woman.
","Systemic absorption of topical corticosteroids may cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of cushing's syndrome, hyperglycemia, and glucosuria. Patients receiving large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.
",,,,,"Store in a cool and dry place, protected from light. Do not freeze. Keep all medicines out of the reach of children.
",9
+363,Diethylcarbamazine Citrate,diethylcarbamazine-citrate-363,https://medex.com.bd/attachments/YoCF3gb9rpIAS16jcwWw401BTceQHM/diethylcarbamazine-citrate-prescribing-information,Other Anti-protozoals,Toxocariasis,"Diethylcarbamazine is indicated for Filariasis, Lymphatic filariasis, Pulmonary eosinophilia, Loiasis, Toxocariasis.
","Other Anti-protozoals
","The mechanism of action of diethylcarbamazine is thought to involve sensitizing the microfilariae to phagocytosis. One study showed that diethylcarbamazine's activity against Brugia malayi microfilariae is dependent on inducible nitric-oxide synthase and the cyclooxygenase pathway. It confirmed the important role of the arachidonic acid metabolic pathway in diethylcarbamazine's mechanism of action in vivo and showes that in addition to its effects on the 5-lipoxygenase pathway, it targets the cyclooxygenase pathway and COX-1.
","Inital: 1 mg/kg/day, may increase to 6 mg/kg/day over 3 days, then maintain for 3 wk. Prophylaxis of loiasis 300 mg/wk.
",,"There are no known drug interactions and none well documented.
","Pregnancy, hypersensitivity; lactation; infants, elderly or debilitated patients; impaired renal function; cardiac disease.
","Fever, headache, vomiting, dizziness, drowsiness, nausea, chills.
Potentially Fatal: Severe hypersensitivity reactions may occur especially in the treatment of onchocerciasis where rare Mazzotti reaction characterised by rash, itching, headache, muscle and joint pains, tachycardia, postural hypotension may start within 2 hr of drug administration. Encephalitis and retinal haemorrhage.
","Pregnancy Category- X. Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
","Patients with poor health.
Lactation: not known if excreted in breast milk
",,,,,,9
+1864,Dienogest + Estradiol Valerate,dienogest-estradiol-valerate-1864,https://medex.com.bd/attachments/uPEnLiO2NE4ANtaadVqaorKFYDt8kx/dienogest-estradiol-valerate-prescribing-information,Female Sex hormones,Contraception,"This is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. The efficacy of this tablet in women with a body mass index (BMI) of >30 kg/m 2 has not been evaluated. Treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception.
","Drugs for menopausal symptoms: Hormone replacement therapy, Female Sex hormones
","COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.
","Take one tablet daily by mouth at the same time every day. Tablets must be taken in the order directed on the blister pack. Do not skip or delay intake by more than 12 hours.
",,"Drugs or herbal products that induce certain enzymes (for example CYP3A4) may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs.
","
+- A high risk of arterial or venous thrombotic diseases
+- Undiagnosed abnormal uterine bleeding
+- Breast cancer or other estrogens- or progestin-sensitive cancer
+
","The most common adverse reactions (≥2%) in clinical trials for Natazia are headache (including migraines) 13%, breast pain 7%, menstrual disorders 7%, nausea or vomiting 6%, acne 4%, mood changes (3%) and increased weight 3%.
",,"
+- Vascular risks: Stop this tablet if a thrombotic event occurs. Stop this tablet at least 4 weeks before and through 2 weeks after major surgery. Start this tablet no earlier than 4 weeks after delivery, in women who are not breastfeeding.
+- Liver disease: Discontinue this tablet if jaundice occurs.
+- High blood pressure: Do not prescribe this tablet for women with uncontrolled hypertension or hypertension with vascular disease.
+- Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking this tablet. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.
+- Headache: Evaluate significant change in headaches and discontinue this tablet if indicated.
+- Uterine bleeding: Evaluate irregular bleeding or amenorrhea.
+- CYP3A4 induction: Women taking strong CYP3A4 inducers (for example, carbamazepine, phenytoin, rifampicin, and St. John’s wort) should not choose this tablet as their oral contraceptive due to the possibility of decreased contraceptive efficacy.
+
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+362,Dienogest,dienogest-362,https://medex.com.bd/attachments/p5y99j3wncgmRB3PeAMurDhhCoBskj/dienogest-prescribing-information,Female Sex hormones,Endometriosis,"Dienoaest is indicated for the treatment of endometriosis. This is the preparation of Dienogest which belongs to the class of medications called progestins. Progestins reduce the effects of estrogen on tissues such as the endometrium (lining of the uterus) and the breast. By reducing the growth effect ... Read more
Dienoaest is indicated for the treatment of endometriosis. This is the preparation of Dienogest which belongs to the class of medications called progestins. Progestins reduce the effects of estrogen on tissues such as the endometrium (lining of the uterus) and the breast. By reducing the growth effect of estrogen on the endometrium, Dienogest helps to reduce the pelvic pain experienced by women with endometriosis.
","Female Sex hormones
","Dienogest acts as an agonist at the progesterone receptor (PR) with weak affinity that is comparable to that of progesterone but has a very potent progestagenic effect in the endometrium, causing endometrial atrophy after prolonged use. It promotes antiproliferative, immunologic and antiangiogenic effects on endometrial tissue. Dienogest reduces the level of endogenous production of oestradiol and thereby suppressing the trophic effects of oestradiol on both the eutopic and ectopic endometrium. Continous administration of dienogest results in hyperprogestogenic and moderately hypoestrogenic endocrine environment, which causes initial decidualization of endometrial tissue. It is an antagonist at androgen receptors, improve androgenic symptoms such as acne and hirsutism [A16570].
","Tablet-taking can be started on any day of the menstrual cycle. The dosage of Dienogest is 2 mg daily without any break, taken preferably at the same time each day with some liquid as needed. Tablet must be taken continuously without regard to vaginal bleeding. When a pack is finished, the next one should be started without interruption.
In the event of missed tablet(s), the woman should take 2 mg only, as soon as she remembers, and should then continue the next day to take the tablet at her usual time. A tablet not absorbed due to vomiting or diarrhea should likewise be replaced by 2 mg.
",,"Progestogens including Dienogest are metabolized mainly by the cytochrome P450 3A4 system . Therefore, inducers or inhibitors of CYP3A4 may affect the progestogen drug metabolism. Known CYP3A4 inhibitors like azole antifungals (e.g, ketoconazole, itraconazole, fluconazole), cimetidine, verapamil, macrolides (e.g, erythromycin, clarithromycin and roxithromycin), diltiazem, protease inhibitors (e.g, ritonavir, saquinavir, indinavir, nelfinavir), antidepressants (e.g, nefazodone, fluvoxamine, fluoxetine) may increase plasma levels of progestogens and result in adverse reactions.
","Hypersensitivity to dienogest or to any of the excipients of Dienogest. Dienogest should not be used in the presence of any of the conditions such as, Active venous thromboembolic disorder; arterial and cardiovascular disease, (e.g, myocardial infarction, cerebrovascular accident, ischemic heart disease); diabetes mellitus with vascular involvement; presence or history of severe hepatic disease as long as liver function values have not returned to normal; presence or history of liver tumors (benign or malignant); known or suspected sex hormone-dependent malignancies and undiagnosed vaginal bleeding.
","Undesirable effects are more common during the 1st months after start of intake of Dienogest, and subside with duration of treatment. The following undesirable effects have been reported in users of Dienogest. The most frequently reported undesirable effects during treatment that were considered at least possibly related to Dienogest were headache (9%), breast discomfort (5.4%), depressed mood (5.1%) and acne (5.1%).
+
+- Nervous System Disorders: Headache, migraine.
+- Cardiac Disorders: Uncommon: Unspecified circulatory system disorder, palpitations.
+- Vascular Disorders: Uncommon: Hypotension.
+- Gastrointestinal Disorders: Common: Nausea, abdominal pain, flatulence.
+- Metabolism and nutrition disorders: Weight increase (3.6%)
+- Psychiatric Disorders: Depressed mood, irritability, nervousness, altered mood.
+
","There are limited data from the use of Dienogest in pregnant women. Animal studies and data from women exposed to Dienogest during pregnancy reveal no special risks on pregnancy, embryonic/fetal development, birth or development after birth for humans. However, Dienogest should not be administered to pregnant women because there is no need to treat endometriosis during pregnancy.
Treatment with Dienogest during lactation is not recommended. Physiochemical properties and animal data indicate excretion of Dienogest in breast milk. A decision must be made whether to discontinue breastfeeding or to abstain from Dienogest therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
","Before starting Dienogest treatment, pregnancy must be excluded. During treatment, patients are advised to use nonhormonal methods of contraception (e.g, barrier method) if contraception is required.
As Dienogest is a progestogen-only preparation, it can be assumed that special warnings and special precautions for use of other progestogen-only preparations are also valid for the use of Dienogest .
+
+- Changes in Bleeding Pattern: Dienogest treatment affects the menstrual bleeding pattern in the majority of women.
+- Hepatic Impairment: Dienogest is contraindicated in patients with present or past severe hepatic disease.
+- Impairment of Fertility: Based on available data, ovulation is inhibited in the majority of patients during treatment with Dienogest. However, Dienogest is not a contraceptive. If contraception is required, a nonhormonal method should be used.
+
","Use in Children: Dienogest is not indicated in children prior to menarche. The safety and efficacy of Dienogest in adolescents (menarche to 18 years) has not yet been established.
Use in the Elderly: There is no relevant indication for the use of Dienogest in the geriatric population.
","Acute toxicity studies performed with Dienogest did not indicate a risk of acute adverse effects in case of inadvertent intake of a multiple of the daily therapeutic dose. There is no specific antidote. Dienogest 20-30 mg/day (10-15 times higher dose than in Dienogest) over 24 weeks of use were very well tolerated.
",,,"Keep in a cool and dry place. Protect from light. Keep out of the reach of children.
",12
+361,Dicycloverine Hydrochloride,dicycloverine-hydrochloride-361,https://medex.com.bd/attachments/yogYG3IGFcerofZqItox1SjLYaejMk/dicycloverine-hydrochloride-prescribing-information,Anticholinergics (antimuscarinics)/ Anti-spasmodics,Spasm,"Dicycloverine is indicated in:
+
+- Functional bowel/irritable bowel syndrome
+- Urinary incontinence secondary to unstable detrusor muscle
+- Infantile colic
+- GIT spasm
+- Colicky abdominal pain
+- Diverticulitis
+- Abdominal colic
+
","Anticholinergics (antimuscarinics)/ Anti-spasmodics
","Dicycloverine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent. Chemically, it is [Bicyclohexyl-]1-carboxylic acid, 2-(diethylammo) ethyl ester, hydrochloride. Dicycloverine relieves smooth muscle spasm of the gastrointestinal tract. Dicycloverine HCl Injection is a sterile, pyrogen-free, aqueous solution for intramuscular injection (Not For Intravenous Use). It works at specific receptors, called cholinergic (or muscarinic) receptors, located on the involuntary muscle in the walls of the gut. By binding to these receptors dicycloverine prevents certain chemicals produced by the body from interacting with these receptors. This causes the gut muscle to relax, relieving the pain of colic produced by gut muscle contraction and spasm.
","For oral dosage forms:
+
+- Adults:10 to 20 mg three times a day.
+- Children over 6 months of age: 5 to 10 mg three times a day.
+
+For injectable dosage form:
+
+- Adults: Intramuscular injection. Not for intravenous use. The recommended intramuscular dose is 80 mg daily (in 4 equally divided doses).
+
+Oral dicycloverine Hydrochloride should be started as soon as possible and the intramuscular form should not be used for periods longer than 1 or 2 days.
Children: Dose must be determined by the doctor.
",,,,"Insomnia, mydriasis, cycloplegia, increased ocular tension, urinary hesitancy, palpitations, dyspnea.
","Pregnancy Category B. Dicycloverine was neither teratogenic nor embryocidal in animal trial. It, like other drugs should be used during pregnancy only if clearly needed. There are no data on the secretion of this drug into breast milk. Dicycloverine should be used cautiously in case of lactating mother.
","Use with caution in patients with autonomic neuropathy, hepatic or renal disease, ulcerative colitis, coronary heart disease, congestive heart failure, cardiac tachyarrhythmia, hiatal hernia, known or suspected prostatic hypertrophy.
",,"Toxic reaction seldom occurs with dicycloverine. The signs and symptoms of overdosage are headache; nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dryness of the mouth; difficulty in swallowing; and CNS stimulation.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+358,Diclofenac Sodium + Misoprostol,diclofenac-sodium-misoprostol-358,https://medex.com.bd/attachments/PONm1XNEaJEsp91F0vwu2ReFFnzEVQ/diclofenac-sodium-misoprostol-prescribing-information,Drugs for Osteoarthritis,Rheumatoid arthritis,"This combination is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications.
","Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","It is a combination product containing Diclofenac Sodium, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic properties and Misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin E 1 analog. The mechanism of action of Diclofenac Sodium, like other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition. NSAIDs inhibit prostaglandin synthesis. A deficiency of prostaglandins within the gastric and duodenal may lead to diminish bicarbonate and mucosal secretion and may contribute to mucosal damage caused by NSAIDs. Misoprostol can increase bicarbonate and mucous production & prevents gastric and duodenal ulcers.
","Osteoarthritis: The recommended dosage for maximal GI mucosal protection is Diclofenac Sodium 50 mg & Misoprostol 200 µg tid. For patients who experience intolerance, Diclofenac Sodium 75 mg & Misoprostol 200 µg bid or Diclofenac Sodium 50 mg & Misoprostol 200 µg bid can be used.
Rheumatoid arthritis: The recommended dosage is Diclofenac Sodium 50 mg & Misoprostol 200 µg tid or qid. For patients who experience intolerance, Diclofenac Sodium 75 mg & Misoprostol 200 µg bid or Diclofenac Sodium 50 mg & Misoprostol 200 µg bid can be used.
",,"Aspirin: Concomitant administration with aspirin is not recommended because Diclofenac Sodium is displaced from its binding sites by aspirin, resulting in lower plasma concentrations, peak plasma levels and AUC values.
Digoxin: Elevated digoxin levels have been reported in patients receiving digoxin and Diclofenac Sodium. Antihypertensives: NSAIDs can inhibit the activity of antihypertensives, including ACE inhibitors.
Warfarin: The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious bleeding greater than users of either drug alone.
Oral hypoglycaemics: Diclofenac Sodium does not alter glucose metabolism in healthy people nor it alters the effects of oral hypoglycaemics. Diclofenac Sodium may alter diabetic patient’s response to insulin or oral hypoglycaemics.
Antacids: Antacids reduce the bioavailability of Misoprostol. Antacids may also delay absorption of Diclofenac Sodium.
Diuretics: The Diclofenac Sodium component like other NSAIDs, can inhibit the activity of diuretics. Concomitant therapy with potassium-sparing diuretics may be associated with increased serum potassium levels.
","This is contraindicated in patients with hypersensitivity to Diclofenac, Misoprostol or to other prostaglandins. This should not be given to patients who have experienced asthma, urticaria or other allergic-type reactions after taking aspirin or other NSAIDs.
","The most common reported side effects are abdominal pain, diarrhea and other GI symptoms. Diarrhea and abdominal pain developed early in the course of therapy and were usually self-limited (resolved after 2 to 7 days). Rare instances of profound diarrhea leading to severe dehydration have been reported in patients receiving Misoprostol.
","Because of the abortifacient property of the Misoprostol component, this is contraindicated in women who are pregnant. Diclofenac Sodium has been found in the milk of nursing mothers. Diclofenac Sodium plus Misoprostol is not recommended for use by nursing mothers.
","Patients with an underlying condition such as inflammatory bowel disease or those in whom dehydration should be monitored carefully if Diclofenac Sodium plus Misoprostol is prescribed.
","Paediatric use: Safety and effectiveness of Diclofenac Sodium and Misoprostol combination in paediatric patients have not been established.
Geriatric use: No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some elderly person cannot be ruled out. As with any NSAID, the elderly are likely to tolerate adverse events less well than younger patients.
","Misoprostol: Convulsions, sedation, tremor, dyspnoea, diarrhoea, abdominal pain, fever, palpitations, hypotension, bradycardia. Management: Supportive treatment.
Diclofenac: Lethargy, drowsiness, nausea, vomiting, epigastric pain, GI bleeding. HTN, acute renal failure, resp depression, anaphylactoid reactions and coma may occur rarely
",,,"Store in a cool and dry place below 25º C. Protect from light.
",12
+1453,Diclofenac Sodium + Methyl Salicylate + Linseed Oil + Menthol,diclofenac-sodium-methyl-salicylate-linseed-oil-menthol-1453,https://medex.com.bd/attachments/TAN8HJny4QX4r3EKaqebYRkRdWzndb/diclofenac-sodium-methyl-salicylate-linseed-oil-menthol-prescribing-information,Non-steroidal Anti-inflammatory Drugs (NSAIDs),Pain and inflammation associated with musculoskeletal and joint disorders,"Indicated for the quick relief from pain, swelling and inflammation due to musculo-skeletal disorders such as sprains, strains, tendinitis, bursitis, hands, neck & shoulder pain, sciatica, muscle stiffness, joint pain, back ache and lumbago.
","Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Diclofenac Diethylamine is systemically absorbed through the skin; it inhibits the enzyme cyclooxygenase, thus reducing the formation of PGE2. Moreover, it also increases the uptake of Arachidonic acid into the cellullar pool. Menthol is a vasodilator. It dilates the blood vessels, produces a feeling of coolness and produces analgesia. Methyl salicylate is a known anti-inflammatory agent.
","Approximately one-inch band of gel should be applied to the affected site three to four times daily with rubbing till the film disappears. Safety and effectiveness in pediatric patients have not been established.
",,,"Known hypersensitivity to any part of the preparation.
","Usually well tolerated. Extremely low frequency of hypersensitivity reactions.
","The safety of this gel has not been established during pregnancy. There are no well-controlled studies of diclofenac in pregnant women.
","For external use only. Avoid contact with the eyes. Stop use and ask a doctor if condition worsens or does not improve within 7 days. Keep out of the reach of children. If swallowed, get medical help or contact a poison control center right away.
",,,,,"Store below 25°C. Protect from light. Do not freeze. Keep out of reach of children. Close cap tightly after each application.
",9
+356,Diclofenac Sodium + Lidocaine Hydrochloride,diclofenac-sodium-lidocaine-hydrochloride-356,,Drugs for Osteoarthritis,Osteoarthritis (degenerative arthritis),"The injection contains Diclofenac Sodium that is used to relief all grades of pain and inflammation in a wide range of conditions including:
+
+- Arthritic conditions such as rheumatoid arthritis, osteoarthritis, juvenile chronic arthritis, ankylosing spondylitis, acute gout.
+- Acute musculoskeletal disorders such as periarthritis (e.g., Frozen shoulder), tendinitis, tenosynovitis, bursitis.
... Read more
The injection contains Diclofenac Sodium that is used to relief all grades of pain and inflammation in a wide range of conditions including:
+
+- Arthritic conditions such as rheumatoid arthritis, osteoarthritis, juvenile chronic arthritis, ankylosing spondylitis, acute gout.
+- Acute musculoskeletal disorders such as periarthritis (e.g., Frozen shoulder), tendinitis, tenosynovitis, bursitis.
+- Other painful conditions resulting from trauma including, fracture, low back pain, sprains, strains, dislocations, control of pain and inflammation in orthopaedic, dental and other minor surgeries, postoperative pain, pain of renal colic etc.
+
+The injection also contains Lidocaine which acts as a local anaesthetic. Therefore the possibility of pain at the injection site, which is most likely to occur after intramuscular injection, is minimized if the Lidocaine containing injection is used in the above indications.
","Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Diclofenac Sodium is a potent nonsteroidal antiinflammatory drug (NSAID) with marked analgesic and antipyretic properties. It also has some uricosuric effects. The action of Diclofenac appeared to be associated with the inhibition of prostaglandin synthesis. Diclofenac may inhibit synthesis of prostaglandins by inhibiting cyclooxygenase, an enzyme that catalyses the formation of prostaglandin precursors from arachidonic acid. Peak plasma concentration is achieved within half an hour following injection. Lidocaine is the most widely used local anaesthetic drug. It acts more rapidly and is more stable than most other local anaesthetics. It is a very useful surface anaesthetic. Like other local anaesthetics, Lidocaine impairs the generation and conduction of nerve impulses by slowing depolarization. The onset of anaesthesia of Lidocaine Hydrochloride is more rapid and the duration is 1-2 hours.
","Adult: One ampoule once (or in severe cases, twice) daily by intramuscular injection.
Renal colic: One ampoule once daily intramuscularly. A second dose may be administered after 30 minutes if necessary.
Children: In Juvenile chronic arthritis, 1-3 mg of Diclofenac Sodium per kg body weight daily in divided doses.
Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, commensurate with age and physical status, or as prescribed by the physician.
",,"Lithium and Digoxin: Diclofenac may increase plasma concentrations of Lithium and Digoxin.
Anticoagulants: There are isolated reports of an increased risk of haemorrhage with the combined use of Diclofenac and anticoagulant therapy, although clinical investigations do not appear to indicate any influence on anticoagulant effect.
Antidiabetic agents: Clinical studies have shown that Diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect.
Cyclosporin: Cases of nephrotoxicity have been reported in patients receiving Cyclosporin and Diclofenac concomitantly.
Methotrexate: Cases of serious toxicity have been reported when Methotrexate and NSAIDs are given within 24 hours of each other.
Quinolone antimicrobials: Convulsions may occur due to an interaction between quinolones and NSAIDs. Therefore, caution should be exercised when considering concomitant therapy of NSAIDs and quinolones.
Other NSAIDs and steroids: Co-administration of Diclofenac with other systemic NSAIDs and steroids may increase the frequency of unwanted effects. With Aspirin, the plasma levels of each are lowered, although no clinical significance is known.
Diuretics: Various NSAIDs are liable to inhibit the activity of diuretics. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels. So, serum potassium should be monitored.
","It is contraindicated for those patients who are hypersensitive to Diclofenac. In patients with active or suspected peptic ulcer or gastrointestinal bleeding or for those patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by Aspirin or other NSAIDs possessing prostaglandin synthetase inhibiting activity Diclofenac is also contraindicated. Because of the presence of Lidocaine, this injection is also contraindicated for those patients who are hypersensitive to local anaesthetics of the amide type, although the incidence is very rare. In patients with Adams-Stokes syndrome or with severe degrees of SA, AV, or intraventricular heart block in the absence of an artificial pacemaker, and for those patients who are hypersensitive to any of the excipients used in the formulation (Sodium Metabisulphite, Disodium Edetate, Benzyl Alcohol, Sodium Hydroxide, Propylene Glycol), this injection is also contraindicated.
","Side effects to Diclofenac Sodium and Lidocaine injection are usually mild and transient. However if serious side effects occur the injection should be discontinued. Gastrointestinal discomfort, nausea, diarrhea and occasionally bleeding may occur. In very rare instances, injection site disorder may occur. In isolated cases, abscesses and local necrosis may occur. The adverse effects due to Lidocaine mainly involve the CNS, are usually of short duration, and are dose related. The CNS reactions may be manifested by drowsiness, dizziness, disorientation, confusion, lightheadedness etc.
","It should not be prescribed during pregnancy unless there are compelling reasons for doing so. The lowest effective dosage should be used. These types of drugs are not recommended during the last trimester of pregnancy. Very small quantities of Diclofenac may be detected in breast milk, but no undesirable effects on the infant are to be expected.
","Renal: Patients with severe hepatic, cardiac or renal insufficiency or the elderly should be kept under close observation, since the use of NSAIDs may result in deterioration of renal function. The lowest effective dose should be used and renal function should be monitored.
Hepatic: If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), Diclofenac should be discontinued. All patients who are receiving long term treatment with NSAIDs should be monitored as a precautionary measure (e.g., renal, hepatic function and blood counts).
",,,,,"Store at temparature not exceeding 30°C in a dry place. Protected from light.
",10
+359,Diclofenac Sodium (Ophthalmic),diclofenac-sodium-ophthalmic-359,https://medex.com.bd/attachments/EgF7UL64I4aivLNiXGgGW52Dw01IsN/diclofenac-sodium-ophthalmic-prescribing-information,Ophthalmic Non-Steroid drugs,Ocular inflammation,"Diclofenac Sodium ophthalmic preparation is indicated in-
+
+- Inhibition of miosis during cataract surgery.
+- Post-operative inflammation after cataract surgery and other ocular surgical procedures.
+- Pre-operative and post-operative prevention of cystoid macular edema (CME) associated with lens extraction & intraocular lens implantation.
... Read more
Diclofenac Sodium ophthalmic preparation is indicated in-
+
+- Inhibition of miosis during cataract surgery.
+- Post-operative inflammation after cataract surgery and other ocular surgical procedures.
+- Pre-operative and post-operative prevention of cystoid macular edema (CME) associated with lens extraction & intraocular lens implantation.
+- Post-traumatic inflammation in penetrating and non- penetrating wounds (as an adjuvant to local anti-infective therapy).
+- Non-infected chronic conjunctivitis, keratoconjunctivitis.
+
","Ophthalmic Non-Steroid drugs
","Diclofenac Eye Drops contains Diclofenac Sodium, a potent non-steroidal anti-inflammatory drug with analgesic property. Diclofenac Sodium produces anti-inflammatory effect by inhibiting cyclooxygenase activity with a reduction in the tissue prostaglandin ( such as PgE2 and Pg F2α) .
","Ophthalmic (Adult)-
+
+- Postoperative ocular inflammation: Instill into the appropriate eye 4 times daily starting 24 hr after surgery for up to 28 days.
+- Inflammation and discomfort after strabismus surgery: Instill 1 drop 4 times daily for the 1st wk; then tid in the 2nd wk, bid in the 3rd wk, and as required for the 4th wk.
+- Pain and discomfort after radial keratotomy: Instill 1 drop before surgery followed by 1 drop immediately after surgery, and then 1 drop 4 times daily for up to 2 days.
+- Pain after accidental trauma: Instill 1 drop 4 times daily for up to 2 days.
+- Control of inflammation after argon laser trabeculoplasty: Instill 1 drop 4 times during the 2 hr before procedure followed by 1 drop 4 times daily, up to 7 days after procedure.
+- Prophylaxis of intra-operative miosis: Instill into appropriate eye 4 times w/in 2 hr before surgery.
+- Post-photorefractive keratectomy pain: Instill into the affected eye twice, an hr before surgery, then 1 drop twice at 5-min intervals immediately after surgery, then every 2-5 hr while awake for up to 24 hr.
+- Seasonal allergic conjunctivitis: Instill 1 drop before surgery followed by 1 drop immediately after surgery, and then 1 drop 4 times daily for up to 2 days.
+
",,"No drug interaction is reported. There should be at least 5 minutes interval when another ophthalmic solution (e.g., steroid) is given.
","Hypersensitivity to any of the components Like other non steroidal anti-inflammatory agents, Diclofenac Sodium eye drops is contraindicated in patients in whom attacks of asthma, urticaria or acute rhinitis have been observed following application of acetyl salicylic acid or other cyclo-oxygenase inhibitors
","Mild to moderate burning sensation in 5-15% patients which is transient in nature and almost never necessitated discontinuation of treatment. Other less common side-effects are sensitivity to light, bad taste, feeling of pressure, allergic reactions etc.
","The safety of Diclofenac eye drops in pregnancy & lactation has not been established and its use therefore is not recommended unless the potential benefit to the mother outweighs the possible risk to the child.
","Diclofenac eye drops may mask the signs of infection. So physicians should be alert to the development of infections in patients receiving the drug. During prolonged use, it is recommended that physicians conduct periodic examinations of the eye, including measurement of the intraocular pressure. Contact lenses should not be worn during treatment.
",,"Accidental ingestion of Diclofenac Sodium presents virtually no risk of unwanted effects, since one 5 ml bottle of eye drop solution contains only 5 mg of Diclofenac Sodium, which is equivalent to about 3% of the recommended maximum oral dose for adults.
",,,"Close the bottle immediately after use. Do not use for more than four weeks after opening. Store at room temperature.
",11
+357,Diclofenac Sodium,diclofenac-sodium-357,https://medex.com.bd/attachments/E3be8nBw5XF5i87saE2nZ74gE0VCeJ/diclofenac-sodium-tablet-prescribing-information,Drugs for Osteoarthritis,Tendonitis,"Rheumatology: Inflammatory and degenerative forms of rheumatism, chronic involutive, polyarthritis, ankylosing spondylarthritis, osteoarthritis, spondylarthroses, acute gout, peri-articular rheumatic disorders.
Surgery and Traumatology: Sprain, bruises, dislocations ... Read more
Rheumatology: Inflammatory and degenerative forms of rheumatism, chronic involutive, polyarthritis, ankylosing spondylarthritis, osteoarthritis, spondylarthroses, acute gout, peri-articular rheumatic disorders.
Surgery and Traumatology: Sprain, bruises, dislocations, fractures, softtissue injuries, surgical interventions.
Obstetrics and Gynecology: Primary dysmenorrhoea, episiotomy, adnexitis, endometritis, parametritis, salpingitis, and mastitis.
Otorhinolaryngology: As pre-operative medication for the prevention of pain, inflammation, and swelling.
Dentistry: Post-operative and post-traumatic pain, inflammation, and swelling.
Other indications: For the prevention of pain and treatment of inflammation and swelling of patients operated in the urogenital tract, renal and biliary colic.
","Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Dilofenac Sodium is a potent non-steroidal anti-inflammatory drug (NSAID) with pronounced anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. It has also some uricosuric effect. Diclofenac exerts its effect by inhibiting prostaglandin biosynthesis which plays a major role in causing inflammation, pain and fever. Diclofenac is rapidly and completely absorbed from the gastro-intestinal tract when taken with or after meal. Peak plasma concentrations are reached within an average of 2 hours after ingestion of it. At therapeutic concentrations, it is 99.7% bound to plasma proteins. Diclofenac is metabolized in the liver and undergoes first pass metabolism.
","Diclofenac FC Tablet: Adults: 75-150 mg daily in 2 to 3 divided doses, preferably after food. Dose should be reduced in long term use.
Diclofenac SR Tablet:
+
+- Adult: 1 tablet daily, taken whole with liquid, preferably at meal times. If necessary, the daily dose can be increased to 150 mg by supplementation with conventional tablets.
+- Children: 1-3 mg of diclofenac/kg body wt. daily in divided doses.
+- Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, although the pharmacokinetics of diclofenac sodium is not impaired to any clinically relevant extent in elderly patients.
+
+
Diclofenac Dispersible Tablet:
+
+- Adults: The recommended daily dosage is 2-3 tablets and the maximum daily dose is 150 mg. In milder cases, 2 tablets of Diclofenac DT per day are sufficient. Diclofenac DT should preferably be taken before meals.
+- Children: Diclofenac is not recommended in children for other indications except juvenile rheumatoid arthritis where the recommended dose is 1-3 mg/kg body weight. Diclofenac DT is to be dropped into a half-glass of water and the liquid is to be stirred to aid dispersion before swallowing. There is no information on the use of Diclofenac DT for more than 03 months.
+
+
Diclofenac TR Capsule: One capsule daily. Diclofenac TR should be taken preferably after mealtimes.
Diclofenac Suppository: For adults: 50 mg suppository 2-3 times daily. Maximum daily dose is 150 mg.
Diclofenac injection: For adults the usual dose is 1 ampoule daily. In serious cases this dose may be increased up to 2 ampoules daily.
Diclofenac Gel: For external use only. Depending on the size of area to be treated, 2-4 g of Diclofenac gel should be applied to the skin 3-4 times daily. To the affected area gel should be rubbed in lightly. This gel may also be given in addition to further treatment with other dosage forms of Diclofenac.
",,,"Contraindicated to the patients hypersensitive to any ingredient of the products. Peptic ulcer, hypersensitivity to Diclofenac like other non-steroid anti-inflammatory agents, Diclofenac is also contra-indicated in asthmatic patient in whom attack with asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibitor. This Gel should not be used under occlusive airtight dressings.
","Diclofenac Sodium is generally well tolerated. Adverse effects are mild, rare and transient. At the starting of the treatment, however, patients may be sometimes complaining of epigastric pain, eructation, nausea and diarrhea or dizziness or headache. These effects are usually mild in nature. Peripheral edema and skin reactions, such as rash and eczema have also been encountered. Diclofenac Sodium Gel may cause local irritation and reddening of the skin and skin rash.
","During pregnancy, Diclofenac should be employed only for compelling reasons. The lowest effective dose should be used. These types of drugs are not recommended during the first trimester of pregnancy. In view of insufficient clinical data, Diclofenac Sodium Gel is not recommended during pregnancy. A very insignificant quantity of Diclofenac may be detected in breast milk but no undesirable effects on the infant to be expected.
","In rare instances where peptic ulceration or gastrointestinal bleeding occurs in patients under treatment with Diclofenac. In patients with advanced age should be kept under close observation. Diclofenac Sodium Gel should not be allowed to come in contact with the eyes or mucus membranes, after application the hands should be washed properly and not to be taken by mouth.
",,,,,"Store in a cool and dry place, protected from light. Store below 30°C. Keep out of the reach of children.
",9
+1184,Diclofenac Potassium,diclofenac-potassium-1184,https://medex.com.bd/attachments/c9tdjUrIYil7ufm58sAqMRcatQQ3An/diclofenac-potassium-tablet-immediate-release-prescribing-information,Drugs for Osteoarthritis,Tendonitis,"Short-term treatment in the following acute conditions:
+
+- Post-traumatic pain, inflammation and swelling,e.g.due to sprains
+- Post-operative pain, inflammation and swelling,e.g.following dental or orthopaedic surgery
+- Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis
... Read more
Short-term treatment in the following acute conditions:
+
+- Post-traumatic pain, inflammation and swelling,e.g.due to sprains
+- Post-operative pain, inflammation and swelling,e.g.following dental or orthopaedic surgery
+- Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis
+- Migraine attacks
+- Painful syndromes of the vertebral column
+- Non-articular rheumatism
+- As an adjuvant in severe painful inflammatory infections of the ear, nose, or throat, e.g. pharyngotonsillitis, otitis.
+
","Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","The mechanism of action of Diclofenac Potassium, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).
Diclofenac is a potent inhibitor of prostaglandin synthesis in vitro. Diclofenac concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because diclofenac is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.
","Adults: Following an initial loading dose of 50 mg, 25-50 mg is to be taken every eight hours if necessary.
Migraine: An initial loading dose of 50 mg, then if necessary a further 25-50 mg after 2 hours. The maximum daily dose is 150 mg. The tablets should be swallowed whole with liquid, preferably before meals.
Children: Children over 14 years of age: upto 75 mg daily in divided doses.
",,"Diclofenac may have the following drug interactions:
+
+- Lithium and Digoxin: Diclofenac may increase plasma concentrations of Lithium and Digoxin.
+- Anticoagulant:There are isolated reports of and increased risk of haemorrhage with the combined use of Diclofenac and anticoagulant therapy.
+- Cyclosporin: Cases of nephrotoxicity have been reported in patients receiving Cyclosporin and Diclofenac concomitantly.
+- Methotrexate: Cases of serious toxicity have been reported when Methotrexate and NSAIDs are given within 24 hours of each other.
+- Diuretics: Like other NSAIDs, Diclofenac may inhibit the activity of diuretics.
+- Other NSAIDs and steroids; Co-administration of Diclofenac with other systemic NSAIDs and steroids may increase the frequency of unwanted effects.
+
","Diclofenac Potassium tablets are contraindicated in patients with known hypersensitivity to Diclofenac. Diclofenac should not be given to patients who have experienced asthma, urticaria, or allergic type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. Diclofenac is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
","Side-effects of Diclofenac are usually mild and transient. However, if serious side-effects occur. Diclofenac should be discontinued. Occasional: epigastric pain, other gastro-intestinal disorders (e.g., nausea, vomiting, diarrhoea, abdominal cramps, dyspepsia,flatulence,anorexia). Rare: gastro-intestinal bleeding, peptic ulcer (with or without bleeding or perforation), bloody diarrhoea.
","Diclofenac should not be prescribed during pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage should be used. This type of drugs are not recommended during the last trimester of pregnancy. Very small quantities of diclofenac may be detected in breast milk, but no undesirable effects on the infant are to be expected.
",,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+1483,Diclofenac Diethylamine + Mephenesin + Menthol + Methyl Salicylate + Turpentine Oil,diclofenac-diethylamine-mephenesin-menthol-methyl-salicylate-turpentine-oil-1483,,Topical Analgesics,Pain,"This topical gel is a Non-steroidal anti-inflammatory (NSAID) drug used to treat pain associated with conditions like gout, migraine, rheumatoid arthritis, sprains of muscles and joints etc.
","Topical Analgesics
","Diclofenac Diethylamine, Mephenesin, Menthol, Methyl Salicylate, Turpentine oil works by reducing pain and delayed onset muscle soreness; relieving pruritus; providing relief from painful conditions; providing relief of musculoskeletal aches and pains; reducing the pain.
","Depending on the size of the area to be treated, 2-4 gm of this gel should be applied to the skin 3-4 times daily to the affected area and rubbed in lightly.
",,,"It is contraindicated in patients who have hypersensitivity to this gel. In addition, This gel should not be used if one has the following conditions:
+
+- children less than 12 years old
+- cuts
+- infected skin
+
","The most commonly reported side-effects of this gel are itching, blisters, allergic contact dermatitis, anaphylactic reactions, pruritus, and rash.
","Not recommended.
","This gel should not be allowed to come in contact with the eyes or mucous membranes. After application, the hands should be washed unless they are the sites being treated. Not to be taken by mouth.
",,,,,"It should be stored in a cool and dry place, protected from light and moisture.
",9
+1852,Diazoxide,diazoxide-1852,https://medex.com.bd/attachments/ZgCR4UgI3GFMkZMboacIjBBS2KH7y9/diazoxide-prescribing-information,Combination Oral hypoglycemic preparations,Hypoglycemia,"Diazoxide tablets are used orally in the treatment of intractable hypoglycemia.
Hypoglycaemia: Diazoxide administered orally is indicated for the treatment of intractable hypoglycaemia with severe symptoms from a variety of causes including idiopathic hypoglycaemia in infancy, leucine-sensitive ... Read more
Diazoxide tablets are used orally in the treatment of intractable hypoglycemia.
Hypoglycaemia: Diazoxide administered orally is indicated for the treatment of intractable hypoglycaemia with severe symptoms from a variety of causes including idiopathic hypoglycaemia in infancy, leucine-sensitive or unclassified; functional islet cell tumours both malignant and benign if inoperable, extra-pancreatic neoplasms producing hypoglycaemia; glycogen storage disease; hypoglycaemia of unknown origin. Diazoxide also causes salt and water retention.
","Combination Oral hypoglycemic preparations
","As a diuretic, Diazoxide inhibits active chloride reabsorption at the early distal tubule via the Na-CI cotransporter, resulting in an increase in the excretion of sodium, chloride, and water. Thiazides like Diazoxide also inhibit sodium ion transport across the renal tubular epithelium through binding to the thiazide sensitive sodium-chloride transporter. This results in an increase in potassium excretion via the sodium-potassium exchange mechanism. The antihypertensive mechanism of Diazoxide is less well understood although it may be mediated through its action on carbonic anhydrases in the smooth muscle or through its action on the large-conductance calcium-activated potassium (KCa) channel, also found in the smooth muscle. As a antihypoglycemic, Diazoxide inhibits insulin release from the pancreas, probably by opening potassium channels in the beta cell membrane.
Pharmacodynamics: Diazoxide is a potassium channel activator. Its mechanism of action revolves around enhancing cell membrane permeability to potassium ions. This action consequently elicits the relaxation of local smooth muscles. This switches off voltage-gated calcium ion channels which inhibits the generation of an action potential.
","For both adults and children: a starting oral dose of 5mg/kg body weight divided into 2 or 3 equal doses per 24 hours will establish the patient's response and thereafter the dose can be increased until the symptoms and blood glucose level respond satisfactorily. Regular determinations of the blood glucose in the initial days of treatment are essential. The usual maintenance dose is 3-8mg/kg/day given in two or three divided doses.
Patients with renal impairment: Reduced doses may be required in patients with impaired renal function.
In children with leucine-sensitive hypoglycaemia: A dosage range of 15- 20mg/kg/day is suggested.
In adults with benign or malignant islet-cell tumours producing large quantities of insulin: High dosages of up to 1,000mg per day have been used.
",,"Drugs potentiated by Diazoxide therapy include: oral diuretics, antihypertensive agents and anticoagulants. Phenytoin levels should be monitored as increased dosage may be needed if administered concurrently with diazoxide. The risk of hyperglycaemia may be increased by concurrent administration of corticosteroids or oestrogen-progestogen combinations.
","In the treatment of hypoglycaemia, Diazoxide is contraindicated in all cases which are amenable to surgery or other specific therapy. Hypersensitivity to any component of the preparation or other thiazides
","The adverse reactions are thrombocytopenia, pancreatitis, hypotension, diarrhea, heart failure etc.
","Pregnancy: Reproduction studies using the oral preparation in rats have revealed increased fetal resorptions and delayed parturition, as well as fetal skeletal anomalies; evidence of skeletal and cardiac teratogenic effects in rabbits has been noted with intravenous administration. The drug has also been demonstrated to cross the placental barrier in animals and to cause degeneration of the fetal pancreatic beta cells. Since there are no adequate data on fetal effects of this drug when given to pregnant women, safety in pregnancy has not been established. When the use of Diazoxide is considered, the indications should be limited to those specified above for adults, and the potential benefits to the mother must be weighed against possible harmful effects to the fetus. Diazoxide Tablets are only to be used in pregnant women when the indicated condition is deemed to put the mother's life at risk. Prolonged oral therapy of Diazoxide during pregnancy has been reported to cause alopecia in the newborn.
Nursing mothers: Information is not available concerning the passage of Diazoxide in breast milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions from Diazoxide in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","In the treatment of hypoglycaemia it is necessary that the blood pressure be monitored regularly. Retention of sodium and water is likely to necessitate therapy with an oral diuretic such as frusemide or ethacrynic acid The dosage of either of the diuretics mentioned may be up to 1g daily. It must be appreciated that if diuretics are employed then both the hypotensive and hyperglycaemic activities of Diazoxide will be potentiated and it is likely that the dosage of Diazoxide will require adjustment downwards. In patients with severe renal failure it is desirable to maintain, with diuretic therapy, urinary volumes in excess of 1 litre daily. Hypokalaemia should be avoided by adequate potassium replacement.
Diazoxide should be used with caution in patients with cardiac failure or impaired cardiac reserve in whom sodium and water retention may worsen or precipitate congestive heart failure. A direct effect on myocardium and cardiac function cannot be excluded.
Diazoxide should be used with care in patients with impaired cardiac or cerebral circulation and in patients with aortic coarctation, aortic stenosis, arteriovenous shunt, heart failure or other cardiovascular disorders in which an increase in cardiac output could be detrimental.
Diazoxide should be administered with caution to patients with hyperuricaemia or a history of gout, and it is advisable to monitor serum uric acid concentration.
Whenever Diazoxide is given over a prolonged period regular haematological examinations are indicated to exclude changes in white blood cell and platelet counts.
Also in children there should be regular assessment of growth, bone and psychological maturation.
The very rapid, almost complete protein binding of Diazoxide requires cautious dosage to be used in patients whose plasma proteins may be lower than normal
",,"Excessive dosage of Diazoxide can result in hyperglycaemia. Severe hyperglycaemia may be corrected by giving insulin and less severe hyperglycaemia may respond to oral hypoglycaemics. Hypotension may be managed with intravenous fluids and in severe cases may require sympathomimetics.
",,,"Store below 30°C. Store in the original container in order to protect from moisture. Keep Diazoxide out of reach and sight of the children.
",11
+355,Diazepam,diazepam-355,https://medex.com.bd/attachments/hljg20t7Tfv7Lz53zWCHrG4F7ADfL4/diazepam-tablets-prescribing-information,Primary anti-epileptic drugs,Severe anxiety disorders,"Diazepam is indicated for the short-term treatment of mild to moderate anxiety, excitation, agitation, fear, aggressiveness, etc. Anxiety reactions caused by stressed conditions, anxiety states with somatic expression, acute alcohol withdrawal, status epilepticus, premedication for surgical procedures, febrile convulsions, insomnia of hospitalized patients.
","Benzodiazepine sedatives, Centrally acting Skeletal Muscle Relaxants, Primary anti-epileptic drugs
","Diazepam attaches to the specific site on the GABA receptor and potentiates the effect of GABA, which acts by opening chloride ion channels into cells.
Diazepam is absorbed rapidly and completely after oral administration. Peak Plasma concentration reaches within 15-90 minutes. Mean plasma half-life is 30 hours. Plasma protein binding is 98-99%. Diazepam is metabolized in the liver with only traces of the unchanged drug excreted in urine. A very small proportion of the metabolites is excreted through the bile into the intestine and eliminated with the feces. After rectal administration in suppository form diazepam is significantly absorbed and peak concentration reaches within 1.5-2 hours.
","Oral:
+
+- Anxiety: 2 mg thrice daily, increased if necessary to 15-30 mg daily in divided doses. Elderly (or debilitated), half of the adult dose.
+- Insomnia associated with anxiety: 5-15 mg at bedtime.
+- Night terrors and somnambulism in Child: 1-5 mg at bedtime.
+
+IM/slow IV injection (large vein, a rate below 5 mg/minute):
+
+- For severe acute anxiety, control of acute panic attacks, and acute alcohol withdrawal: 10 mg repeated if necessary after not less than 4 hours.
+- Febrile convulsion in children: Slow IV in a dose of 250 mcg/kg.
+
+Rectal:
+
+- In case of children- A dose of 500 mcg/kg (maximum 10 mg), repeated if necessary.
+
",,"Concomitant intake with alcohol is not recommended. Sedation may be increased due to concomitant use of neuroleptics (antipsychotics), hypnotics, sedative antihistamines and CNS depressants e.g., general anesthetics, narcotic analgesics or antidepressants. Diazepam clearance is increased by concomitant administration of phonobarbitone and is decreased by administration of cimetidine. Omeprazole and isoniazide inhibit diazepam metabolism.
","Diazepam is contraindicated in myasthenia gravis, pulmonary insufficiency, respiratory depression and hypersensitivity to bezodiazepine.
","Diazepam is generally well tolerated. Higher doses may cause somnolence, dizziness, light headedness, confusion and ataxia.
","Diazepam and its active metabolites cross the placental barrier and also pass into breast milk. So, it should be avoided if possible during pregnancy and lactation. US FDA pregnancy category D.
","Prolonged use and abrupt withdrawal should be avoided. Diazepam should be used with caution in respiratory disease, muscle weakness, history of drug or alcohol abuse, in hepatic or renal impairment.
",,"Sedation, muscle weakness, profound sleep or paradoxical excitation. In more severe cases symptoms may include ataxia, hypotonia, hypotension, respiratory depression and rarely coma and death.
",,,"Store in a cool (below 25˚C temperature) and dry place protected from light.
",11
+1260,Diabasic Sodium Phosphate + Monobasic Sodium Phosphate,diabasic-sodium-phosphate-monobasic-sodium-phosphate-1260,https://medex.com.bd/attachments/zA1rOrt9NVpfneW3sek7rX9OFN3VJw/diabasic-sodium-phosphate-monobasic-sodium-phosphate-prescribing-information,Enema & bowel cleansing solution,Cleansing of the colon,"For the relief of occasional constipation. For use where bowel cleansing is required, such as before and after lower bowel surgery, delivery and post-partum, before proctoscopy, sigmoidoscopy or colonoscopy and before radiological examinations of the lower bowel.
","Enema & bowel cleansing solution
","It acts as a saline laxative when administered by the rectal route. Fluid accumulation in the lower bowel produces distension and promotes peristalsis and bowel movement on the rectum, sigmoid and descending colon. These phenomena results in rapid evacuation.
","Adults, Elderly and Children over 12 years old: 118 ml delivered dose, not more than once daily or as directed by a physician. Additional liquids by mouth are recommended. Encourage patients to drink large amounts of clear liquids to prevent dehydration.
",,"Use with caution in patients taking calcium channel blockers, diuretics, lithium treatment or other medications that might affect electrolyte levels as hyperphosphataemia, hypocalcaemia, hypokalae- mia, hypernatraemic dehydration and acidosis may occur. No other sodium phosphate preparations including sodium phosphate oral solution or tablets should be given concomitantly. As hypernatraemia is associated with lower lithium levels, concomitant use of this medicine and lithium therapy could lead to a fall in serum lithium levels with a lessening of effectiveness.
","Do not use in patients with, Congestive heart failure, impairment of renal function, gastrointestinal obstruction, Megacolon, Paralytic ileus, Perforation, Active inflammatory bowel disease, Imperforate anus, Dehydration, Children under 2 years of age, Hypersensitivity to active ingredients or to any of the excipients of the product.
","Phosphate Enema is well tolerated when used as indicated. However, adverse events possibly associated with the use of phosphate enema have been infrequently reported. In some cases, adverse events may occur, especially if the enema is misused.
","As there is no relevant data available to evaluate the potential for fetal malformation or other feto-toxic effects when administered during pregnancy it should only be used as directed by a physician at the time of delivery or postpartum. As sodium phosphate may pass into the breast milk, it is advised that breast milk is expressed and discarded for at least 24 hours after receiving this medicine.
","Use with caution in patients, with impaired renal function, with pre-existing electrolyte disturbances or who are taking diuretics which may affect electrolyte levels, Who are taking medications known to prolong the QT interval, Ascites, With a colostomy.
",,"Using more than 133 ml in 24 hours can be harmful. In case of excessive dose, recovery from the toxic effects can normally be achieved by rehydration. Treatment of electrolyte imbalance may require immediate medical intervention with appropriate electrolyte and fluid replacement therapy.
",,,"Store below 25° C. Protect from light. Do not refrigerate. Keep out of the reach of children.
",11
+179,Dextrose & Hartmann's Solution,dextrose-hartmanns-solution-179,https://medex.com.bd/attachments/Y5gezfWnRLGQldpApyDCKn6cheOBe4/dextrose-hartmanns-solution-prescribing-information,Intravenous fluid preparations,Source of water,"This solution is indicated as a source of water, electrolytes and calories or as an alkalinizing agent.
","Intravenous fluid preparations
","This is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration.
","As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations. The dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low weight infants, because of the increased risk of hyperglycemia/ hypoglycemia. Additives may be incompatible. Administration Procedure:
+
+- Check infusion set and infusion solution prior to use
+- Pull moderately to tear off the protective cover of the Eurohead
+- Hold lightly the Eurohead but not the bag
+- Open the flow regulator fully and hold the giving set on the top white area, but not the membrane venting region
+- Insert the spike of the administration set to the Eurohead and fit the connector of the administration set firmly to the needle
+- Gradually allow the fluid to flow down to the needle tip and close
+- Remove the protective cover of the needle
+- Locate the veinpuncture site and clean the site with an antiseptic solution, and then insert the needle
+- Securely tape the puncture site
+- Securely tape the wings and tubing
+- Start infusion while adjusting drip speed.
+
",,"There are no known drug interactions and none well documented.
","Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.
","Allergic reactions or anaphylactoid symptoms such as localized or generalized urticaria and pruritus; periorbital, facial, and/or laryngeal edema, coughing, sneezing, and/or difficulty with breathing have been reported during administration. The reporting frequency of these signs and symptoms is higher in women during pregnancy.
","Teratogenic effect and pregnancy category C. This solution should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk.
","Do not uses if the solution is cloudy contain particles or date expired. Infusion of fluid should be immediately discontinued if rigor arises for any reason during the process.
","Pediatric Use: Safety and effectiveness of this solution in pediatric patients have not been established by adequate and well controlled trials.
Geriatric Use: Clinical studies of this solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
",,,,"Should be stored at controlled room temperature.
",11
+350,Dextrose,dextrose-350,https://medex.com.bd/attachments/zU4YJb3hCNt5Sfam9pZoCWmhldg3g1/dextrose-prescribing-information,Intravenous fluid preparations,Fluid and electrolyte imbalance,"Dextrose is administered in the treatment of carbohydrate and fluid depletions. It is mainly used to replace water deficiency and should be given alone when there is no significant loss of electrolytes. Water depletion (dehydration) tends to occur when these losses are not matched by a comparable intake ... Read more
Dextrose is administered in the treatment of carbohydrate and fluid depletions. It is mainly used to replace water deficiency and should be given alone when there is no significant loss of electrolytes. Water depletion (dehydration) tends to occur when these losses are not matched by a comparable intake, as for example may occur in coma or dysphagia or in the aged person who may not drink water in sufficient amount on their own initiative. It provides a readily metabolizable nutrient. One litre of 5% solution provides about 170 calories. Glucose solutions are also given in regimens with calcium bicarbonate, and insulin for the emergency management of hyperkalaemia. They are also given, after correction of hyperglycaemia, during treatment of diabetic ketoacidosis, when they must be accompanied by continuing insulin infusion. Dextrose also may act as a suitable vehicle for the slow intravenous infusion of numerous drugs.
","Intravenous fluid preparations
","Dextrose is a form of glucose (sugar). Dextrose 5% in water is injected into a vein through an IV to replace lost fluids and provide carbohydrates to the body. Dextrose 5% in water is used to treat low blood sugar (hypoglycemia), insulin shock, or dehydration (fluid loss). Dextrose 5% in water is also given for nutritional support to patients who are unable to eat because of illness, injury, or other medical condition.
","5% dextrose solution: The dose of Dextrose infusion is variable. It is dependent on individual patient requirements. For 5% dextrose solution, the dose frequently ranges from 500 to 1000 ml. The maximum rate of infusion that will not cause glycosuria is 0.5 g/kg/hour. About 95% is retained when the rate is 0.8 g/kg/hr. the maximum rate of glucose utilization is about 800 mg per kg body weight per hour.
25% dextrose solution: The volume and rate of infusion of dextrose solution will depend upon the requirements of the individual patient and the judgment of the physician. The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg/hr. The usual recommended flow rate for adult is 10-35 drops per minute infused intravenously. It should not be administered by SC or IM route. 25% dextrose solution should be infused through the largest available peripheral vein.
","
+- Check infusion set and infusion solution prior to use.
+- Pull moderately to tear off the protective cover of the Eurocap.
+- Hold lightly the Eurocap but not the bottle body.
+- Open the flow regulator fully and hold the giving set on the top white area, but not the memorane venting region.
+- Insert the spike of the administration set to the Eurocap and fit the connector of the administration set firmly to the needle.
+- Gradually allow the fluid to flow down to the needletip and close.
+- Remove the protective cover of the needle.
+- Locate the venpuncture site and clean the site with an antiseptic solution, and then insert the needle.
+- Securely tape the puncture site.
+- Securely tape the wings and tubing
+- Start infusion while adjusting drip speed.
+
",,"Do not take this medicine and tell your doctor if: You should not use this medication if you are allergic to dextrose. Before using dextrose 5% in water, tell your doctor if you have diabetes, breathing problems, an electrolyte imbalance, kidney or liver disease, a food or drug allergy, or if you receive regular blood transfusions.
","
+- severe burning, pain, or swelling around the IV needle;
+- warmth, redness, oozing, or bleeding where the IV was placed;
+- fever, ongoing cough;
+- high blood sugar, headache, trouble concentrating, memory problems, weakness, feeling unsteady, hallucinations, fainting, seizure, shallow breathing or breathing that stops;
+- low potassium or anxiety, sweating, pale skin, severe shortness of breath, wheezing, pain, fast or uneven heart rate.
+
","FDA pregnancy category C. It is not known whether dextrose 5% in water will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether dextrose 5% in water passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
","Serum glucose concentration should be carefully monitored. Concurrent use of insulin may be needed in case of diabetic patients. Dextrose solution should not be mixed with whole blood as haemolysis and clumping may occur. Infusion of fluid should be immediately discontinued if rigor arises for any reasons during the process. Do not use if the solution is cloudy, contains particles, or after expiry date.
Take special care with dextrose. Check with your doctor before taking this medicine if: You should not use this medication if you are allergic to dextrose.
To make sure you can safely use dextrose 5% in water, tell your doctor if you have any of these other conditions:
+
+- diabetes;
+- breathing problems;
+- an electrolyte imbalance (such as low levels of potassium in your blood);
+- kidney or liver disease;
+- any allergy to foods or medicines; or
+- if you receive regular blood transfusions.
+
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+1774,Dextromethorphan Hydrobromide + Guaifenesin,dextromethorphan-hydrobromide-guaifenesin-1774,https://medex.com.bd/attachments/8qJLiaZJBRfAZ9BdaQsfZNOCB0jAlh/dextromethorphan-hydrobromide-guaifenesin-prescribing-information,Combined cough expectorants,Dry cough,"This preparation provides relief from all the symptoms associated with common cold such as dry cough, chest congestion etc.
","Combined cough expectorants, Cough expectorants & mucolytics
","This tablet is a combination of Guaifenesin and Dextromethorphan HBr. Dextromethorphan is a cough suppressant and gives relief from cough by blocking the cough centre in the brain. Guaifenesin is an expectorant. It reduces the viscosity of cough by increasing the flow of fluids in the bronchial secretion thereby facilitating the expectoration of cough.
","Adults and children 12 years and older: 1 or 2 tablets every 12 hours and not more than 4 tablets daily.
+
+- Do not crush, chew, or break tablet
+- Take with a full glass of water
+- This product can be administered without regard for the timing of meals.
+
",,,"This tablet is contraindicated in patients with known hypersensitivity to Dextromethorphan and Guaifenesin. Moreover, the patients who are taking monoamine oxidase inhibitor (MAOI) certain drugs or for 2 weeks after stopping the MAOI drug cannot take this preparation.
","Common side effects are hypersensitivity, rash, nausea & vomiting.
","There is no information regarding safety in pregnancy and lactation. So consultation with physician is must before use in this case.
",,"Usage in children: This tablet is not indicated for the children under 12 years of age.
",,,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",9
+347,Dextromethorphan Hydrobromide,dextromethorphan-hydrobromide-347,https://medex.com.bd/attachments/pWL5rwStPY8jQ2nq3xiGrch2ifrJoR/dextromethorphan-hydrobromide-prescribing-information,Cough suppressant,Non-productive cough,"Dextromethorphan is indicated in Chronic dry cough or unproductive cough; Acute dry cough which is interfering with normal function or sleep.
","Cough suppressant
","Dextromethorphan suppresses the cough reflex by a direct action on the cough center in the medulla of the brain. Dextromethorphan shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist and acts as a non-competitive channel blocker. It is one of the widely used antitussives, and is also used to study the involvement of glutamate receptors in neurotoxicity.
","Adults and Children over 12 years: 15 to 30 mg three to four times per day. However, 60 mg doses up to four times per day have been used without increased side effects.
Children between 6 and 12 years: 5-15 mg up to four times per day.
Children between 2 and 6 years: 2.5-5 mg up to four times per day.
",,"The following medicines should be taken carefully while concomitantly use with Dextromethorphan: Amiodarone, Fluoexetine, Quinidine, CNS depressants and Monoamine oxidase (MAO) inhibitors.
","Hypersensitivity to Dextromethorphan or any other component.
","Adverse effects with Dextromethorphan are rare, but nausea and dizziness sometimes occur. The drug produces no analgesia or addiction and little or no CNS depression. Excitation, confusion and respiratory depression may occur after overdosage.
","Pregnancy: Adequate and well-controlled studies in human have not been done. However, Dextromethorphan has not been reported to cause birth defects.
Lactation: It is not known whether dextromethorphan passes into breast milk. However, Dextromethorphan has not been reported to cause problems in nursing babies.
","Do not use Dextromethorphan to control a cough that is associated with smoking, asthma, or emphysema, or a cough that is productive (produces sputum or phlegm).
",,"Symptoms: In mild overdose, tachycardia, hypertension, vomiting, mydriasis, diaphoresis, nystagmus, euphoria, loss of motor coordination, and giggling; in moderate intoxication, in addition to those listed above, hallucinations and a plodding ataxic gait; in severely intoxication, agitation or somnolence.
Management: treatment is symptomatic and supportive. Naloxone may be useful in reversing toxicity.
",,,"Store at 15-30° C
",11
+386,Donepezil Hydrochloride,donepezil-hydrochloride-386,https://medex.com.bd/attachments/EXoNlLxba69LcNVljHaxDBBtcHbfvO/donepezil-hydrochloride-prescribing-information,Drugs for Dementia,Mild to moderate dementia in Alzheimer’s disease,"Donepezil is indicated for the symptomatic treatment of mild to moderate dementia of Alzheimer's type.
","Drugs for Dementia
","Donepezil Hydrochloride is a centrally acting anticholinesterase agent. It binds reversibly with acetylcholinesterase and inactivates it, thus inhibiting hydrolysis of acetylcholine. As a result the concentration of acetylcholine increases at cholinergic synapses in the brain.
","5 mg once daily orally at bed time. The 5 mg/day dose should be maintained for at least one month in order to allow the earliest clinical responses to treatment to be assessed and to allow steady-state concentrations of donepezil hydrochloride to be achieved. Following a one-month clinical assessment of treatment at 5 mg/day, the dose can be increased to 10 mg/day (once-a-day dosing). Since food does not affect the rate or extent of absorption of donepezil, it can be administered with or without food.
",,"Drugs with anticholinergic properties and which cross into the brain, such as atropine, benztropine produce the opposite effects of Donepezil and should be avoided during therapy with donepezil. Medication with carbamazepine, dexamethasone, phenobarbital, phenytoin may reduce the effect of donepezil whereas ketoconazole, quinidine, cimetidine may increase the effects.
","Donepezil is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives.
","Generally well tolerated but some patients may experience nausea, vomiting & diarrhoea. These adverse events are of mild intensity and transient, resolving during continued treatment without the need for dose modification. Less frequent side effects are insomnia, fatigue, anorexia, muscle cramps, generalized seizure etc.
","There are no adequate and well controlled studies in pregnant woman. Donepezil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Donepezil Hydrochloride is secreted in human breast milk or not. Donepezil is not indicated in nursing mother.
","Caution should be taken in sick sinus syndrome or other supraventricular conduction abnormalities, patients at risk of developing peptic ulcers, asthma, obstructive airway disease and during anaesthetic procedure.
","Renal & hepatic impairment: A similar dose schedule can be followed for patients with renal or mild to moderate hepatic impairment as clearance of donepezil hydrochloride is not affected by these conditions.
Use in children: There are no adequate and well controlled trials in document to safety and efficacy of Donepezil hydrochloride in any illness occurring in children. Donepezil is not recommended for use in children.
","Symptoms of overdose includes nausea, vomiting, salivation. Over dosage with very high dose of donepezil may result in cholinergic crisis characterized by severe nausea, vomiting, salivation, bradycardia, hypotension, increasing muscle weakness, respiratory depression, collapse and convulsion. As in any case of over dose, general supportive measures should be utilized. In case of cholinergic crisis hospitalization of the patient is required.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+380,Domperidone Maleate,domperidone-maleate-380,https://medex.com.bd/attachments/dWdLGuiM7Mw5rBBI3Rx1dQJ9IO6yow/domperidone-maleate-tablets-oral-suspension-prescribing-information,Motility Stimulants,Vomiting,"Dyspeptic symptom complex, often associated with delayed gastric emptying, gastroesophageal reflux and esophagitis:
+
+- Epigastric sense of fullness, feeling of abdominal distension, upper abdominal pain
+- Eructation, flatulence, early satiety
+- Nausea and vomiting
... Read more
Dyspeptic symptom complex, often associated with delayed gastric emptying, gastroesophageal reflux and esophagitis:
+
+- Epigastric sense of fullness, feeling of abdominal distension, upper abdominal pain
+- Eructation, flatulence, early satiety
+- Nausea and vomiting
+- Heartburn with or without regurgitations of gastric contents in the mouth
+- Non-ulcer dyspepsia
+
+
Acute nausea and vomiting of the functional, organic, infectious, dietetic origin or induced by radiotherapy or drug therapy or induced in migraine.
Parkinson's disease: In dopamine-agonist induced nausea and vomiting.
Radiological studies: Speeding barium transit in follow-through radiological studies.
","Motility Stimulants, Motility stimulants/Dopamine antagonist, Prokinetic drugs
","Domperidone is a dopamine antagonist that principally blocks the dopamine receptors located in the ChemoreceptorTrigger Zone (CTZ) and stomach. Its gastroprokinetic action is based on its blocking effect of dopamine receptors that have an influence on the motility of the gastrointestinal tract. Due to its weak penetration across the blood-brain barrier, Domperidone has almost no effect on the dopaminergic receptors in the brain, therefore, excluding psychotropic and neurologic side effects. Domperidone restores normal motility and tone of the upper gastrointestinal tract, facilitates gastric emptying, enhances antral and duodenal peristalsis and regulates contraction of the pylorus. Domperidone also increases esophageal peristalsis and lower esophageal sphincter pressure, and thus prevents regurgitation of gastric content.
","Domperidone should be taken 15-30 minutes before meals and, if necessary, before retiring.
The usual recommended oral dose of Domperidone is as follows:
+
+- Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily. The maximum dose of Domperidone is 80 mg daily.
+- Children: 2-4 ml suspension/10 kg body weight or 0.4-0.8 ml paediatric drops/10 kg body weight, every 6-8 hours daily.
+
+In dyspeptic symptom:
+
+- Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily.
+- Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily.
+
+In acute and sub-acute conditions (mainly in acute nausea and vomiting):
+
+- Adults: 20 mg (2 tablets or 20 ml suspension), every 6-8 hours daily
+- Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily. (In acute nausea and vomiting maximum period of treatment is 12 weeks).
+
+By rectum in suppositories:
+
+- Adults (including elderly): 30-60 mg every 4-8 hours.
+- Children: The maximum daily dose rectally in children's is 30 mg for those weighting 10 to 25 kg. The dose may be divided throughout day if necessary.
+- The maximum period of treatment is 12 weeks.
+
",,"Domperidone may reduce the risk of hypoprolactemic effect of bromocriptine. The action of Domperidone on Gl function may be antagonized by antimuscarinics and opoid analgesics. Care should be exercised when domperidone is administered in combination with MAO (monoamine oxidase) inhibitors.
","Domperidone is contraindicated to patients having known hypersensitivity to this drug and in the case of neonates. Domperidone should not be used whenever gastrointestinal stimulation might be dangerous i.e., gastrointestinal hemorrhage, mechanical obstruction or perforation. Also contraindicated in patients with prolactin releasing pituitary tumor (prolactinoma).
","Domperidone may produce hyperprolactinemia (1.3%).This may result in galactorrhea, breast enlargement, and soreness and reduced libido. Dry mouth (1%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhea (0.2%), skin rash and itching (0.1%) may occur during treatment with domperidone. Extra-pyramidal reactions are seen in 0.05% of patients in clinical studies.
","The safety of domperidone has not been proven and it is therefore not recommended during pregnancy. Animal studies have not demonstrated the teratogenic effect in the fetus. Domperidone may precipitate galactorrhea and improve post-natal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.
","Domperidone should be used with absolute caution in the case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood-brain barrier. Since domperidone is highly metabolized in liver, it should be used with caution in patient with hepatic impairment.
",,"There are no reported cases of overdose.
",,,"Store below 30°C, Protected from light & moisture. Keep out of children's reach.
",11
+378,Docusate Sodium (Oral),docusate-sodium-oral-378,https://medex.com.bd/attachments/HLUWqrGUL4sSocGlC6RNbfzu7G7dTN/docusate-sodium-oral-prescribing-information,Stool softener,Constipation,"Docusate Sodium oral preparations are indicated to prevent and treat chronic constipation, as follows:
+
+- soften hard, dry stools in order to ease defecation and reduce straining at stool;
+- in the presence of hemorrhoids and anal fissure, prevent hard, dry stools and reduce straining.
... Read more
Docusate Sodium oral preparations are indicated to prevent and treat chronic constipation, as follows:
+
+- soften hard, dry stools in order to ease defecation and reduce straining at stool;
+- in the presence of hemorrhoids and anal fissure, prevent hard, dry stools and reduce straining.
+
+Docusate Sodium oral preparations are also used as an adjunct in abdominal radiological procedures.
","Stool softener
","Docusate sodium works by allowing more water to be absorbed by the stool. Docusate does not stay in the gastrointestinal tract, but is absorbed into the bloodstream and excreted via the gallbladder after undergoing extensive metabolism. The effect of docusate may not necessarily be all due to its surfactant properties. Perfusion studies suggest that docusate inhibits fluid absorption or stimulates secretion in the portion of the small intestine known as the jejunum.
","Route of administration: Oral.
+
+- Adults and elderly: One to five Docusate Sodium oral preparations should be taken daily in divided doses. Treatment should be commenced with large doses, which should be decreased as the condition of the patient improves.
+- For use with barium meals: Four Docusate Sodium oral preparations to be taken with the meal.
+- Children under 12 years: Not recommended.
+
",,"Docusate Sodium softgel capsules should not be taken concurrently with mineral oil.
","Docusate Sodium softgel capsule is contra-indicated in patients with hypersensitivity to Docusate Sodium.
","Rarely, Docusate Sodium softgel capsules can cause diarrhea, nausea, abdominal cramps or skin rash.
","There are no adequate data from the use of the drug in pregnant women. Animal studies are insufficient with respect to effects on pregnancy and embryonic foetal development. The potential risk for humans is unknown. During wide use, no adverse consequences have been reported. Use in pregnancy only if the benefits outweigh the risks. Docusate sodium is excreted in breast milk and should therefore, be used with caution in lactating mothers.
","Docusate Sodium capsule should not be administered when abdominal pain, nausea, vomiting or intestinal obstruction is present. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Organic disorders should be excluded prior to the administration of any laxative. The treatment of constipation with any medicinal product is only adjuvant to a healthy lifestyle and diet, for example, increased intake of fluids and dietary fiber and advice on appropriate physical activity. If laxatives are needed every day, or if there is persistent abdominal pain, patients need to consult with physicians. Do not use this medicine if patients are intolerant to small quantities of sugar (sorbitol, fructose).
",,"In rare cases of overdose, excessive loss of water and electrolytes should be treated by encouraging the patient to drink plenty of fluid. Electrolyte loss should be replenished where appropriate.
",,,"Store in a cool and dry place, protected from light.
",11
+1813,Docusate Sodium (Ear drop),docusate-sodium-ear-drop-1813,https://medex.com.bd/attachments/vwBIszyqRkAfVYKK0j5otqHom5JcOl/docusate-sodium-ear-drop-prescribing-information,Cerumenolytic,Removal of earwax,"Docusate Sodium ear drops is indicated as an aid in the removal of ear wax.
","Cerumenolytic
","Ear wax which often obstructs the external auditory meatus of the ear contains less than 50% of fatty matter derived from secretions of the sebaceous ceruminous glands. The majority of the wax consists of desquamated epithelium, foreign matter and shed hairs. This non-fatty material forms a matrix holding together the granules of fatty matter to form the ceruminous mass. The addition of oils or solvents binds the mass more firmly together, but aqueous solutions, if they are able to penetrate the matrix, cause a disintegration of the ceruminous mass. Docusate Sodium ear drops, because of their low surface tension and miscibility, rapidly penetrate the dry matrix of the ceruminous mass, reducing the solid ear wax to a semi-solid debris.
","Adults (including the elderly): Apply Docusate Sodium ear drops sufficient to fill the affected ear on not more than two consecutive nights.
Children (from 1 year): As for adult dose.
If the Docusate Sodium is not ejected, ear-syringing might be required, patients should consult their doctor.
","To apply, tilt head to one side so that the ear is facing up. Then gently pull the ear lobe up & backward in case of adults and children older than 3 years. In case of pediatric patients gently pull the ear lobe down & backward. Gently drip the Docusate Sodium ear drops into blocked ear until it is full. Moisten a cotton wool ball with Docusate Sodium ear drops. Place the cotton wool ball in the ear to act like a plug. In the morning remove the cotton wool ball.
","Interaction with other medicinal products and other forms of interaction: Unknown.
","Docusate Sodium is contraindicated in patients with perforation of the eardrum or inflammation of the ear.
","Immune system disorders: hypersensitivity/allergic reactions; Skin disorders: contact dermatitis and allergic skin reactions; General disorders: Application site reactions rarely including transient stinging or irritation may occur.
","Docusate Sodium can be used in case of pregnancy & lactation. As it is a non-systemic application, there is no information to suggest that Docusate Sodium ear drops should not be used during pregnancy and lactation.
","If pain or inflammation is experienced, treatment should be discontinued.
",,"Excess Docusate Sodium ear drops may seep from the ear and treatment of any resulting adverse events, such as skin irritation should be symptomatic.
",,,"Keep away from light and moisture, store below 25°C.
",12
+376,Docetaxel Trihydrate,docetaxel-trihydrate-376,https://medex.com.bd/attachments/gVSrxaywYlvyevHNh5Anpfb3aJSswK/docetaxel-trihydrate-prescribing-information,Cytotoxic Chemotherapy,Stomach carcinoma,"Docetaxel is a microtubule inhibitor indicated for:
+
+- Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC
+- Non-small Cell Lung Cancer (NSCLC) ... Read more
Docetaxel is a microtubule inhibitor indicated for:
+
+- Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC
+- Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC
+- Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer
+- Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction
+- Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN
+
","Cytotoxic Chemotherapy
","Docetaxel is an antineoplastic agent, which acts by disrupting the microtubular network in cells that is essential for vital mitotic and interphase cellular functions. Docetaxel promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly. Docetaxel binds to free tubulin thereby decreasing the critical intracellular concentration of tubulin. The promoted polymerization of microtubules leads to the production of microtubule bundles without normal function and to the stabilization of microtubules, resulting in the inhibition of mitosis in cells. The binding of Docetaxel to microtubules does not alter the number of protofilaments in the bound microtubules; in that, it differs from other spindle poisons. Docetaxel was found to be cytotoxic in vitro against various murine and human tumor cell lines, and against freshly excised human tumor cells in clonogenic assays. In addition, Docetaxel was found to be active on a number of cell lines overexpressing the p-glycoprotein, which is encoded by the multidrug resistant gene.
","Administer in a facility equipped to manage possible complications (e.g., anaphylaxis). Administer intravenously (IV) over 1 hr every 3 weeks. PVC equipment is not recommended. Use only a 21 gauge needle to withdraw docetaxel from the vial.
+
+- BC locally advanced or metastatic: 60 mg/m2 to 100 mg/m2 single agent
+- BC adjuvant: 75 mg/m2 administered 1 hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 cycles
+- NSCLC: after platinum therapy failure: 75 mg/m2 single agent
+- NSCLC: chemotherapy-naive: 75 mg/m2 followed by cisplatin 75 mg/m2
+- HRPC: 75 mg/m2 with 5 mg prednisone twice a day continuously
+- GC: 75 mg/m2 followed by cisplatin 75 mg/m2 (both on day 1 only) followed by fluorouracil 750 mg/m2 per day as a 24-hr IV (days 1-5), starting at end of cisplatin infusion
+- SCCHN: 75 mg/m2 followed by cisplatin 75 mg/m2 IV (day 1), followed by fluorouracil 750 mg/m2 per day as a 24-hr IV (days 1–5), starting at end of cisplatinin fusion; for 4 cycles
+- SCCHN: 75 mg/m2 followed by cisplatin 100 mg/m2 IV (day 1), followed by fluorouracil 1000 mg/m2 per day as a 24-hr IV (days 1–4); for 3 cycles
+
+
For all patients:
+
+- Premedicate with oral corticosteroids
+- Adjust dose as needed
+
",,"Docetaxel is a CYP3A4 substrate. In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds that induce, inhibit, or are metabolized by cytochrome P450 3A4.
","Docetaxel is contraindicated in patients with:
+
+- Neutrophil counts of <1500 cells/mm3
+- A history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80. Severe reactions, including anaphylaxis, have occurred
+
","The most common adverse reactions across all docetaxel indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia. Incidence varies depending on the indication. Adverse reactions are described according to indication. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
","Based on findings in animal reproduction studies and its mechanism of action, docetaxel can cause fetal harm when administered to a pregnant woman. There is no information regarding the presence of docetaxel in human milk, or on its effects on milk production or the breastfed child. No lactation studies in animals have been conducted.
","
+- Docetaxel should be administered under the supervision of a physician experienced in the use of antineoplastic agents
+- There is a higher risk of developing severe adverse reactions including toxic death and fatal gastrointestinal hemorrhage in patients with hepatic impairment
+- Docetaxel therapy should not be given to patients with neutrophil counts of less than 1,500 cells/mm3
+- Fatal cases of enterocolitis, including ischemic colitis, colitis and neutropenic enterocolitis have been reported
+- Severe hypersensitivity reactions, with a potential fatal outcome, requiringb immediate discontinuation of Docetaxel may occur. Patients should be closely monitored
+- Treatment related acute myeloid leukemia may occur. No studies have been conducted to assess the carcinogenic potential of Docetaxel
+
",,"There were a few reports of overdosage. There is no known antidote for docetaxel overdose. In case of overdose, the patient should be kept in a specialised unit and vital functions closely monitored. In case of overdosage, exacerbation of adverse events may be expected. The primary anticipated complications of overdosage would consist of bone marrow suppression, peripheral neurotoxicity and mucositis. Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose. Other appropriate symptomatic measures should be taken, as needed.
",,,"Store between 2°C and 25°C and protected from light. Freezing does not adversely affect the product.
",11
+375,Dobutamine,dobutamine-375,https://medex.com.bd/attachments/jnURah3hGaSdeGYqul27amCqEJGDjd/dobutamine-prescribing-information,Inotropic-sympathomimetics,Heart failure,"Dobutamine Hydrochloride is indicated when inotropic support is necessary for the treatment of patients with hypoperfusion states in whom cardiac output is insufficient to meet circulatory demands. Dobutamine Hydrochloride is also indicated when inotropic support is required for the treatment of patients ... Read more
Dobutamine Hydrochloride is indicated when inotropic support is necessary for the treatment of patients with hypoperfusion states in whom cardiac output is insufficient to meet circulatory demands. Dobutamine Hydrochloride is also indicated when inotropic support is required for the treatment of patients in whom abnormally increased ventricular filling pressures introduce the risk of pulmonary congestion and oedema.
","Inotropic-sympathomimetics
","Dobutamine exerts positive inotropic effect on the myocardium by stimulating β1-adrenergic receptors, thereby increasing myocardial contractility, stroke vol and cardiac output.
","Recommended Dosage: The rate of infusion needed to increase cardiac output has ranged from 2.5 to 10 mcg/kg/min in the majority of patients. Frequently, doses up to 20 mcg/kg/min are required for adequate haemodynamic improvement. On rare occasions, infusion rates up to 40 mcg/kg/min have been reported.
The rate of administration and the duration of therapy should be adjusted according to the patient's response, The indicators are: haemodynamic parameters such as heart rate and rhythm, arterial pressure, and, whenever possible, cardiac output and measurements of ventricular filling pressures and signs of pulmonary congestion. Concentrations up to 5,000 mg/L have been administered to humans. The final volume administered should be determined by the fluid requirements of the patient. Rather than abruptly discontinuing therapy with Dobutamine Hydrochloride, it is often advisable to decrease the dosage gradually.
Rates of Infusion Based on Concentration of Dobutamine Hydrochloride. The rates of fluid infusion that are required to deliver specific dosages are a function of the concentration of Dobutamine Hydrochloride in the infusate. The following table provides a guideline of infusion rates (mL/kg/min) required for 3 frequently used concentrations of Dobutamine Hydrochloride (250, 500, and 1000 mg/L).
","Because of its short half-life, Dobutamine Hydrochloride must be administered as a continuous intravenous infusion. Following the initiation of a constant rate infusion, or upon changing the rate, a steady-state dobutamine plasma concentration is achieved within approximately 10 minutes. Thus, loading doses or bolus injections are not necessary and are not recommended.
","The potency of Dobutamine Hydrochloride may be decreased if the patient is given b-adrenergic receptor antagonists. In such a case, the unopposed a-agonist effects of Dobutamine Hydrochloride may become apparent, including peripheral vasoconstriction and hypertension. Conversely, a-adrenergic blockade may make the b-1 and b-2 effects apparent, resulting in tachycardia and vasodilatation.
There has been no overt indication of medicine interactions in clinical studies in which Dobutamine Hydrochloride was administered concurrently with other medicines, including digitalis preparations, furosemide, spironolactone, lidocaine, nitroglycerin, nitroprusside, isosorbide dinitrate, morphine, atropine, heparin, protamine, potassium chloride, folic acid, and paracetamol.
","Dobutamine Hydrochloride is contraindicated in patients who have shown previous manifestations of hypersensitivity to Dobutamine Hydrochloride.
","Increased Heart Rate, Blood Pressure, And Ventricular Ectopic Activity: A 10- to 20-mm increase in systolic blood pressure and an increase in heart rate of 5 to 15 beats/minute have been noted in most patients (see WARNINGS regarding exaggerated chronotropic and pressor effects). Approximately 5% of patients have had increased premature ventricular beats during infusions. These effects are dose related.
Hypotension: Precipitous decreases in blood pressure have occasionally been described in association with dobutamine therapy. Decreasing the dose or discontinuing the infusion typically results in rapid return of blood pressure to baseline values. In rare cases, however, intervention may be required and reversibility may not be immediate.
Reactions At Sites Of Intravenous Infusion: Phlebitis has occasionally been reported. Local inflammatory changes have been described following inadvertent infiltration. Isolated cases of cutaneous necrosis (destruction of skin tissue) have been reported.
Miscellaneous Uncommon Effects: The following adverse effects have been reported in 1% to 3% of patients: nausea, headache, anginal pain, nonspecific chest pain, palpitations, and shortness of breath. Isolated cases of thrombocytopenia have been reported.
Administration of dobutamine, like other catecholamines, can produce a mild reduction in serum potassium concentration, rarely to hypokalemic levels.
Longer-Term Safety: Infusions of up to 72 hours have revealed no adverse effects other than those seen with shorter infusions.
","Since there are no adequate and well controlled studies in pregnant women, Dobutamine Hydrochloride should not be used during pregnancy unless the potential benefits outweigh the potential risks to the foetus.
It is not known whether this medicine is excreted in human milk. Because many medicines are excreted in human milk, caution should be exercised when Dobutamine Hydrochloride is administered to a nursing woman. If a mother requires dobutamine treatment, breastfeeding should be discontinued for the duration of the treatment.
","During the administration of Dobutamine Hydrochloride, as with any parenteral catecholamine, heart rate and rhythm, arterial blood pressure, and infusion rate should be monitored closely. When initiating therapy, electrocardiographic monitoring is advisable until a stable response is achieved.
",,"Signs And Symptoms: Toxicity from dobutamine hydrochloride is usually due to excessive cardiac β- receptor stimulation. The duration of action of dobutamine hydrochloride is generally short (T½= 2 minutes) because it is rapidly metabolized by catechol-0-methyltransferase. The symptoms of toxicity may include anorexia, nausea, vomiting, tremor, anxiety, palpitations, headache, shortness of breath, and anginal and nonspecific chest pain. The positive inotropicand chronotropic effects of dobutamine on the myocardium may cause hypertension, tachyarrhythmias, myocardial ischemia, and ventricular fibrillation. Hypotension may result from vasodilation.
Treatment: To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians' Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.
The initial actions to be taken in a dobutamine hydrochloride overdose are discontinuing administration, establishing an airway, and ensuring oxygenation and ventilation. Resuscitative measures should be initiated promptly. Severe ventricular tachyarrhythmias may be successfully treated with propranolol or lidocaine. Hypertension usually responds to a reduction in dose or discontinuation of therapy.
Protect the patient's airway and support ventilation and perfusion. If needed, meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. If the product is ingested, unpredictable absorption may occur from the mouth and the gastrointestinal tract. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emisis of lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal.
Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of dobutamine hydrochloride.
",,,"Store between 15-30° C.
",12
+147,Dithranol + Boric Acid + Salicylic Acid,dithranol-boric-acid-salicylic-acid-147,,Dithranol & combined preparations,Psoriasis,"এই অয়েন্টমেন্ট নিন্মোক্ত উপসর্গে নির্দেশিত-
+
","Dithranol & combined preparations
","ডাইথ্রানল: ডাইথ্রানল চর্মের এপিডার্মাল কোষে ATP সরবরাহ বন্ধ করে দিতে পারে, ফলে Keratinocytes এ শক্তি সরবরাহ বন্ধ হয়ে যায়। এই প্রক্রিয়া অন্ততঃ পক্ষে আংশিক ভাবে সোরাইসিসের উপর ডাইথ্রানলের আরোগ্যকর কার্যকারিতা ব্যাখ্যা করা যেতে পারে। ইহার ছত্রাক ধ্বংসের ক্ষমতা রয়েছে।
স্যালিসাইলিক এসিড: ইহা একটি Keratolytic agent. স্যালিসাইলিক এসিড desquamation এর গতি বাড়িয়ে দেয়, ফলে এই প্রক্রিয়ার মাধ্যমে আক্রমণকারী ছত্রাক দূরীভ���ত করে এবং ঔষধ চর্মের ভিতরে প্রবেশে সহায়তা করে। Keratolysis প্রক্রিয়ায় চর্মের এপিডার্মিসের শক্ত অংশ (horny layer) খসে যায়। স্যালিসাইলিক এসিড আন্তঃকোষীয় সংযোজক পদার্থকে (Intercellular cement) দ্রবীভূত করে desquamation প্রক্রিয়া সম্পন্ন করে। উক্ত সংযোজক পদার্থ চর্মের Stratum Corneum এর আঁইশকে Scales সংযুক্ত করে রাখে। স্যালিসাইলিক এসিড প্রধানতঃ খোলস বা আঁইশ খসানো বর্ধিত করে এর কার্যকারিতা প্রদর্শন করে।
বোরিক এসিড: এর ব্যাক্টেরিয়া এবং ছত্রাকের উৎপাদন দমনের (bacteriostatic and fungistatic properties) ক্ষমতা রয়েছে।
","
+- ক্ষতস্থান গরম পানিতে খুব ভাল করে ধুয়ে ফেলুন।
+- তারপর শুকনো ক্ষতস্থানে অল্প পরিমাণে মলম লাগিয়ে দিন (ক্ষতের বাইরে লাগাবেন না)।
+- মলম দিনে একবার, প্রয়োজনবোধে বা চিকিৎসকের পরামর্শ অনুসারে দুইবার ক্ষত না সারা পর্যন্ত নিয়মিতভাবে ব্যবহার করুন।
+- ক্ষত সেরে যাবার পর সম্পূর্ণভাবে আরোগ্য হওয়ার জন্য ৩-৪ দিন পর্যন্ত সামান্য পরিমাণ ব্যবহার করুন।
+
",,"If you use other drugs or over the counter products at the same time, the effects of this ointment may change. This may increase your risk for side-effects or cause your drug not to work properly. Tell your doctor about all the drugs, vitamins, and herbal supplements you are using, so that you doctor can help you prevent or manage drug interactions. this ointment may interact with the following drugs and products:
+
+- Fluocinolone
+- Hydroquinone
+- Isotretinoin
+- None reported
+- Riboflavin
+- Tretinoin
+
","Hypersensitivity to this ointment is a contraindication. In addition, this ointment should not be used if you have the following conditions:
+
+- Acute or actively inflamed psoriatic eruptions
+- After shaving or bathing
+- Avoid use on dentures
+- Breastfeeding
+- Children
+- Do not apply bandage or heating pad
+- Facial psoriasis
+- Genital warts
+- Hypersensitivity
+- Hypersensitivity to this drug
+
","The following is a list of possible side-effects that may occur from all constituting ingredients of this ointment. This is not a comprehensive list. These side-effects are possible, but do not always occur. Some of the side-effects may be rare but serious. Consult your doctor if you observe any of the following side-effects, especially if they do not go away.
+
+- Contact allergic reactions
+- Irritation in skin areas surrounding treated lesions
+- Soreness
+- Temporary discoloration of hair and fingernails
+- Mild cold or burning sensation at the site of application
+- Severe allergic reaction
+- Cardiovascular defects
+- Skeletal variations
+- Mild kidney lesions
+- Infertility
+
","Not recommended during pregnancy. FDA has not yet classified the drug into a specified pregnancy category.
","ক্ষতস্থানের বাইরে স্বাভাবিক চর্মে এবং চোখ বা চোখের নিকটবর্তী স্থানে এই টপিক্যাল অয়েন্টমেন্ট ব্যবহার নিষেধ। এই মলমের কোন উপাদানের প্রতি সংবেদনশীলতা থাকলে এর ব্যবহার করা যাবে না। মলম ব্যবহারের পর ভাল করে হাত ধুয়ে ফেলতে হবে।
",,,,,"Store medicines at room temperature, away from heat and direct light. Do not freeze medicines unless required by package insert. Keep medicines away from children.
",10
+373,Disopyramide Phosphate,disopyramide-phosphate-373,https://medex.com.bd/attachments/XXsVtWYFM6XHHTpCIda2uvb9bkYlvr/disopyramide-phosphate-prescribing-information,Membrane stabilizing agent (Sodium channel blockers),Ventricular tachycardia,"Disopyramide is indicated for the ventricular arrhythmias, especially after myocardial infarction, supraventricular arrhythmias.
","Membrane stabilizing agent (Sodium channel blockers)
","Disopyramide’s Class 1a activity is similar to that of quinidine in that it targets sodium channels to inhibit conduction. Disopyramide depresses the increase in sodium permeability of the cardiac Myocyte during Phase 0 of the cardiac action potential, in turn decreasing the inward sodium current. This results in an increased threshold for excitation and a decreased upstroke velocity.
Disopyramide prolongs the PR interval by lengthening both the QRS and P wave duration. This effect is particularly well suited in the treatment of ventricular tachycardia as it slows the action potential propagation through the atria to the ventricles.
Disopyramide does not act as a blocking agent for beta or alpha adrenergic receptors, but does have a significant negative inotropic effect on the ventricular myocardium. As a result, the use of disopyramide may reduce contractile force up to 42% at low doses and up to 100% in higher doses leading to heart failure.
This provides a possible treatment for atrial and ventricular fibrillation, as it restores pacemaker control of the tissue to the SA and AV nodes
","The recommended dose of Disopyramide is 400 mg /day in 4 divided doses (100 mg capsule 6 hourly).
Patients with renal insufficiency should take 100 mg capsule according to the schedule given below:
Creatinine clearance (ml/min) >15: Approximate dosing q 8 hrq 12 hrq 24 hr
Patients in whom rapid control of ventricular arrhythmia is essential, an initial loading dose of 300 mg Disopyramide is recommended, followed by the appropriate maintenance dosage.
",,,"Disopyramide is contraindicated in the pre-existing A-V heart block, shock, glaucoma, urinary retention and known hypersensitivity to the drug.
","Usually Disopyramide is well tolerated but occasionally in some cases dry mouth/ nose/ eye, nausea, vomiting, diarrhea, bloating, blurred vision, urinary problems, headache, skin rash, dizziness, nervousness & impotence (1-3%) may occur.
","Pregnancy: There are no adequate and well-controlled studies in pregnant women. Disopyramide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: Because of the potential for serious adverse reactions in nursing infants from Disopyramide, a decision should be made whether to discontinue nursing or to discontinue the drug , taking into account the importance of the drug to the mother
","Disopyramide should not be administered to patients with cardiomyopathy and associated congestive heart failure unless the patient is digitalized and adequately compensated. Disopyramide should be used with caution in the presence of digitalis intoxication.
",,"Deliberate or accidental over dosage of oral Disopyramide may be followed by apnea, loss of consciousness & loss of spontaneous respiration. In such a case immediate hospitalization and all life saving measures should be taken.
",,,,9
+371,Dipyridamole,dipyridamole-371,https://medex.com.bd/attachments/uqNM8qYy0pUO0ofbf4td5Ycgs54ROR/dipyridamole-tablets-100-mg-prescribing-information,Anti-platelet drugs,Transient ischemic attack,"Dipyridamole is indicated in Prophylaxis of thromboembolism following cardiac valve replacement, Secondary prophylaxis of stroke or transient ischaemic attack
","Anti-platelet drugs
","Dipyridamole causes an accumulation of adenosine, adenine nucleotides and cAMP by inhibiting the activity of adenosine deaminase and phosphodiesterase thus inhibiting platelet aggregation and may cause vasodilation.
","Prophylaxis of thromboembolism following cardiac valve replacement:
+
+- Adult: 300-600 mg/day in divided doses with an oral anticoagulant.
+- Child: 5 mg/kg/day in divided doses.
+
+Secondary prophylaxis of stroke or transient ischaemic attack:
+
+- Adult: As modified-release preparation: 200 mg bid, with or without aspirin.
+
","Should be taken on an empty stomach. Take 1 hr before meals. May be taken with meals to reduce GI discomfort.
","Aminophylline may reverse vasodilatation effect. Useful combination with aspirin in prevention of thromboembolism. Efficacy reduced by concurrent admin of antacids. Concurrent use may increase the cardiotoxic effects of adenosine.
","Hypersensitivity. Peptic ulcer.
","GI disturbances, headache, dizziness, faintness, facial flushing, skin rash, liver dysfunction, angina. Large doses may lower BP.
","Pregnancy Category B. Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
","In patients with rapidly worsening angina, subvalvular aortic stenosis, haemodynamic instability associated with recent MI or coagulation disorders esp when given IV during myocardial imaging. Hypotension, unstable angina, aortic stenosis. Pregnancy and lactation. Safety and efficacy are not established in childn < 12 yrs.
",,"Symptoms: warm feeling, flushes, sweating, restlessness, weakness, dizziness, hypotension and tachycardia.
Management: treatment is symptomatic. Empty stomach by gastric lavage. Haemodialysis unlikely to be useful.
",,,"Store below 25° C.
",12
+1974,"Diphtheria, Tetanus, Pertussis, Poliomyelitis Vaccine",diphtheria-tetanus-pertussis-poliomyelitis-vaccine-1974,https://medex.com.bd/attachments/pQQRJyDvye1gdTclmbDcSdurn9SApj/diphtheria-tetanus-pertussis-poliomyelitis-vaccine-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Diphtheria,"This vaccine is indicated for the prevention of diphtheria, tetanus, pertussis and poliomyelitis:
+
+- for primary vaccination in infants from the age of 2 months, for booster vaccination, one year after primary vaccination during the second year of life,
+- for booster vaccination between 5 and 13 years of age, according to official recommendations.
+
","Vaccines, Anti-sera & Immunoglobulin
",,"This vaccine must be administered according to the official recommendations in effect. Primary vaccination: 3 injections given at an interval of one month, i.e. according to the official schedule, at the age of 2, 3, 4 months.
Booster vaccination: 1 injection one year after primary vaccination, i.e. usually, between 16 and 18 months. Booster vaccination between 5 and 13 years of age: 1 injection. For primary vaccination and for the first booster dose, this vaccine may be administered by reconstituting the Haemophilus influenzae type b conjugate vaccine (Act-HIB) or administered at the same time as this vaccine, but at two separate injection sites.
Administer via the intramuscular route. Administration should preferably be performed in the antero-lateral side of the thigh (middle third) in infants and in the deltoid area in children
",,"This vaccine can be administered simultaneously with the M-M-RVAXPRO vaccine or with the HBVAXPRO vaccine, but in two separate sites This vaccine can be associated or combined with the Haemophilus influenzae type b conjugate vaccine (Act-HIB).
","Hypersensitivity:
+
+- to any of the active substances of this vaccine,
+- to any of the excipients listed in section 6.1,
+- to glutaraldehyde, neomycin, streptomycin, or polymyxin B (used during the manufacturing process and which may be present as traces)
+- to a pertussis vaccine (acellular or whole cell).
+
+Life-threatening reaction after previous administration of the same vaccine or a vaccine containing the same substances. Vaccination must be postponed in case of febrile or acute disease. Evolving encephalopathy. Encephalopathy within 7 days of administration of a previous dose of any vaccine containing pertussis antigens (whole cell or acellular pertussis vaccines).
","The safety profile is described below according to the clinical data generated in France, South Korea, Chile and Thailand. In clinical studies in children who received TETRAXIM as a primary series, stand alone or combined with the Act- HIB vaccine, the most frequently reported reactions are local injection-site reactions, abnormal crying, loss of appetite and irritability. These signs and symptoms usually occur within 48 hours following the vaccination and may continue for 48-72 hours. They resolve spontaneously without requiring specific treatment. The frequency of injection-site reactions tends to increase at booster vaccination compared with the frequency observed for primary series. The safety profile of TETRAXIM does not differ significantly according to age groups. However certain reactions (myalgia, malaise, headache) are specific to children aged 2 years or more.
",,"The immunogenicity of this vaccine may be reduced by immunosuppressive treatment or immunodeficiency. It is then recommended to wait until the end of the treatment or disease before vaccinating. Nevertheless, vaccination of subjects with chronic immunodeficiency such as HIV infection is recommended even if the immune response may be limited. If Guillain-Barre syndrome or brachial neuritis has occurred in subjects following receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks of vaccination. Vaccination is usually justified for infants whose primary immunization schedules are incomplete (i.e. fewer than three doses administered).
Do not inject via the intravascular route: make sure the needle does not penetrate a blood vessel. Do not inject via the intradermal route. As with all injectable vaccines, This vaccine must be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
",,,,,"Keep out of the reach and sight of children. Store at +2°C to +8°C. Transportation should also be at +2°C to +8 °C. Do not freeze. Discard solution if frozen. Protect from light.
",8
+1973,"Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Influenzae Vaccine",diphtheria-tetanus-pertussis-hepatitis-b-poliomyelitis-influenzae-vaccine-1973,https://medex.com.bd/attachments/Vk7rvUpcTDNJfrYuBrAVg15uW1jkMk/diphtheria-tetanus-pertussis-hepatitis-b-poliomyelitis-influenzae-vaccine-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Diphtheria,"DTaP-IPV-HB-Hib is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib).
","Vaccines, Anti-sera & Immunoglobulin
",,"Primary Vaccination: Three injections at an interval of one to two months (at least four weeks apart).
Booster: At least 6 months after the last dose of first course. This vaccine should be used according to the local vaccination programme.
This should be administered intramuscularly. The recommended injection sites are generally the anterolateral aspect of the upper thigh in infants and toddlers and the deltoid muscle in older children. The intradermal or intravascular route must not be used.; ensure that the needle does not penetrate a blood vessel. Separate syringes, separate injection sites and preferably separate limbs must be used in case of the concomitant administration with other vaccines.
",,,"History of an anaphylactic reaction after a previous administration of this vaccine Encephalopathy within 7 days of administration of a previous dose of any vaccine containing pertussis antigens (whole cell or acellular pertussis vaccines). Uncontrolled neurologic disorder, uncontrolled epilepsy.
","Serious Allergic reactions (anaphylactic reaction): Difficulty in breathing, blueness of tongue/lips, a rash, swelling of face/throat, sudden and dizziness, loss of consciousness, accelerated heart rate with respiratory disorders. Serious allergic reactions are a rare possibility (may up to 1 in 1,000 people) after receiving this vaccine. Other side effects:
+
+- Very common: Anorexia, crying, somnolence, vomiting, pain redness and swelling at injection site, irritability, Fever
+- Common side effects: Prolonged crying, diarrhoea, induration
+- Uncommon side effects: Allergicreaction, lump at injection site, High fever.
+
",,"Vaccination must be postponed in cases of moderate or severe febrile and/or acute disease; the administration of Hexaxim must be carefully considered in individuals who have a history of serious or severe reactions within 48 hours following administration of a vaccine containing similar components. As with all injectable vaccines, the vaccine must be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration. If any of the following events are known to have occurred after receiving any pertussis-containing vaccine, the decision to give further doses of pertussis containing vaccine should be carefully considered:
+
+- The temperature of ≥40°C within 48 hours not due to another identifiable cause;
+- Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination;
+- Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination;
+- Convulsions with or without fever, occurring within 3 days of vaccination. Take special care in case of Guillain Barré Syndrome, Brachial neuritis, acute or chronic renal insufficiency, epilepsy.
+
",,,,,"Keep out of the reach and sight of children. Store at +2°C to +8°C. Transportation should also be at +2°C to +8 °C. Do not freeze. Discard solution if frozen. Protect from light.
",7
+1206,Diphtheria + Pertussis + Tetanus [DPT],diphtheria-pertussis-tetanus-dpt-1206,https://medex.com.bd/attachments/wW127zz01SV8IeQ73tRLxgjlHODxAU/diphtheria-pertussis-tetanus-dpt-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Tetanus,"Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed is a vaccine indicated for active booster immunization against tetanus, diphtheria and pertussis. This Vaccine Adsorbed is approved for use as a single dose in persons 10 through 64 years of age
","Vaccines, Anti-sera & Immunoglobulin
","Diphtheria, Tetanus and Pertussis vaccine prepared from diphtheria formol toxoid, tetanus formol toxoid and pertussis vaccine (killed B pertusis not less than 4 IU from not more than 20000 million organism/0.5 ml); 0.5 ml ampoule: Injection.
","Child: Under 5 yrs, primary immunisation-3 doses of 0.5 ml vaccine by IM or deep SC injection, each dose at an interval of minimum 4 weeks; Over 5 yrs, not recommended.
",,"When Diphtheria, Pertussis & Tetanus vaccine was administered concomitantly with trivalent inactivated influenza vaccine (TIV) to adults 19-64 years of age, a lower antibody response was observed for pertactin antigen as compared to Diphtheria, Pertussis & Tetanus vaccine administered alone.
Immunosuppressive therapies may reduce the immune response to Diphtheria, Pertussis & Tetanus vaccine.
Do not mix this vaccine with any other vaccine in the same syringe or vial
","
+- Severe allergic reaction (eg, anaphylaxis) to any component of Diphtheria, Pertussis & Tetanus vaccine or any other diphtheria toxoid, tetanus toxoid and pertussis antigencontaining vaccine.
+- Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous pertussis antigen-containing vaccine.
+
","The most common solicited injection site reactions occurring within 0-14 days following vaccination with this were:
+
+- For Adolescents 11-17 years of age: pain (77.8%), swelling (20.9%), erythema (20.8%).
+- For Adults 18-64 years of age: pain (65.7%), swelling (21.0%), erythema (24.7%).
+
+The most common solicited systemic reactions occurring within 0-14 days following vaccination with this were:
+
+- For Adolescents 11-17 years of age: headache (43.7%), body ache or muscle weakness (30.4%), tiredness (15.1%).
+- For Adults 18-64 years of age: headache (33.9%), body ache or muscle weakness (21.9%).
+
","Safety and effectiveness of this vaccine have not been established in pregnant women.
","For one presentation of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed, the tip caps of the prefilled syringes may contain natural rubber latex, which may cause allergic reactions in latex sensitive individuals.
If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following a subsequent dose of this vaccine
Progressive or unstable neurologic conditions are reasons to defer this vaccination.
Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine should not receive Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed unless at least 10 years have elapsed since the last dose of a tetanus toxoid containing vaccine.
Syncope (fainting) can occur in association with administration of injectable vaccines, including Diphtheria, Pertussis & Tetanus vaccine. Procedures should be in place to prevent falling injury and manage syncopal reactions.
",,,,,,9
+382,Diphenhydramine Hydrochloride + Zinc Acetate,diphenhydramine-hydrochloride-zinc-acetate-382,https://medex.com.bd/attachments/MER4QPOPuxjymrYYfbc0FuYKrE1gWm/diphenhydramine-hydrochloride-zinc-acetate-prescribing-information,Local Antipruritic,Sunburn,"This cream is used to temporarily relieve pain and itching associated with: insect bites, minor burns, sunburn, minor skin irritations, minor cuts, scrapes, rashes due to poison ivy, poison oak, and poison sumac, dries the oozing and weeping of poison ivy, poison oak, and poison sumac.
","Local Antipruritic, Topical Antihistamines
","Diphenhydramine is an antihistamine and works as a topical anti-allergic and analgesic by blocking the releases of histamine at its sources. Zinc is used as a skin protectant.
","Adults & children above 2 years: Apply to the affected area 3 to 4 times daily. Before application of cream, the skin should be clean, cool and dry. Should not have a hot shower or bath before applying. Apply the cream lightly on the skin until the cream disappears. It is important to include all skin surfaces, such as between the fingers and toes, under the nails and on the soles of the feet.
For babies under 2 years: Initially consult with the physician, if it is recommended, apply to the face, neck, ears and scalp as well, only avoiding the area immediately around the eyes and mouth. Leave cream on for at least 8 hours, before washing off. Reapply to any area that may be washed during the 8 hours treatment time (such as after washing the hands).
",,,"Use of cream is contraindicated in individuals with a known allergy to its components, other pyrethroids or pyrethrins.
","Contact dermatitis with mild erythematous vesicular lesions and papules has occasionally been reported.
","In the absence of specific studies in pregnant women its use in pregnancy should only follow medical advice. However, teratogenic effects would not be anticipated. Although caution should be exercised in administration of diphenhydramine to nursing mothers, levels in breast milk following topical application are likely to be very low.
","For external use only. Flammable, keep away from fire or flame. Do not use on large areas of the body with any other product containing diphenhydramine, even should not be taken by mouth. Consult with the physician before use on chicken pox, on measles. When using this product, avoid contact of eyes.
",,,,,"Store below 30°C. Protect from light. Do not freeze.
",9
+370,Diphenhydramine Hydrochloride,diphenhydramine-hydrochloride-370,https://medex.com.bd/attachments/RgE9T271LHPc9Lxp9OuTd4uE3vjHlC/diphenhydramine-hydrochloride-oral-solution-prescribing-information,Sedating Anti-histamine,Wheezing,"Diphenhydramine is indicated for the treatment of followings:
+
+- Seasonal, perennial, vasomotor rhinitis
+- Urticaria, angioneurotic oedema, anaphylaxis
+- Pruiritic conditions
+- Premedication for emesis and motion sickness
+- Miscellaneous like meniere's disease and parkinsonism
+
","Sedating Anti-histamine
","Diphenhydramine is an antihistamine with anticholinergic and sedative effects. It competes with histamine for H1-receptor sites on effector cells in the GI tract, blood vessels and respiratory tract.
","Adult-
+
+- Most allergic conditions: 25-50 mg three times a day with a further 50 mg at night.
+
+Children-
+
+- 1 to 5 years of age: 5 mg i.e., 2.5 ml of elixir 4 times a day
+- More than 6 years of age: 10 mg i.e. 5 ml of elixir 4 times a day
+
",,"Diphenhydramine administration significantly reduces the absorption of the antituberculous agent para-aminosalicyclic acid (PAS) from the gastrointestinal tract. CNS depressants may potentiate the sedative action of Diphenhydramine. Anticholinergic drugs may potentiate Diphenhydramine’s anticholinergic side effects.
","Known hypersensitivity to Diphenhydramine Hydrochloride, Ammonium chloride is contra-indicated in presence of impaired hepatic or renal function.
","Side effect includes sedation, dizziness, tinnitus, fatigue, ataxia, blurred vision, diplopia, euphoria, and epigastric discomfort.
","Category B: There are no adequate and well controlled studies in pregnant women using diphenhydramine hydrochloride. Therefore, diphenhydramine hydrochloride should be used in pregnancy only if clearly needed. Diphenhydramine hydrochloride has been reported to be excreted in breast milk and thus, use of diphenhydramine hydrochloride in lactating mother is not recommended.
","Caution should be exercised with patients in whom drowsiness is undesirable e.g., drivers, machine operators. Concomitant consumption of alcohol or central nervous system (CNS) depressants will potentiate drowsiness.
",,"Symptoms: Impaired consciousness; psychosis, seizures, antimuscarinic symptoms (e.g. mydriasis, tachycardia, tachyarrhythmias), resp failure, rhabdomyolysis; acute delirium with visual and auditory hallucination (topical).
Management: Supportive and symptomatic treatment. Convulsions and marked CNS stimulation may be treated with IV diazepam.
",,,"Store between 15-30° C. Protect from moisture.
",11
+1463,Diphenhydramine + Levomenthol,diphenhydramine-levomenthol-1463,https://medex.com.bd/attachments/iSMtxHr0OEDNv7ddMHfCOo2trW51cV/diphenhydramine-levomenthol-prescribing-information,Combined cough expectorants,Productive cough,"This preparation is indicated for the relief of cough and associated congestive symptoms. It is also used to relieve runny nose, sneezing, watery eyes, itchy nose/eyes/throat and other allergic symptoms.
","Combined cough expectorants
","Diphenhydramine possesses antitussive and antihistaminic properties. It relieves cough centrally (brain stem) and treats sneezing, runny nose and allergy (itchy eyes, nose, skin). Levomenthol has decongestant and anti-inflammatory properties which helps soothe cough and reduces congestion and inflammation in the nasal passage and lungs that makes breathing easier.
","Adults and Children over 12 years: The recommended dose is 10 ml of syrup 4 times a day. Maximum daily dose is 40 ml syrup.
",,"Diphenhydramine may potentiate the effects of alcohol, codeine, CNS depressants, the effects of anticholinergics (ex- some psychotropic drugs and atropine) and other antihistamines. MAO inhibitors potentiate and intensify the anticholinergic effects of antihistamines.
","This preparation is contraindicated in individuals with known hypersensitivity to the product or any of its constituents and in individuals with chronic or persistent cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by the physician. It should not be administered to patients currently receiving monoamine oxidase inhibitors (MAOIs) or those patients who have received treatment with MAOIs within the last two weeks.
","Diphenhydramine may cause drowsiness, dizziness, gastrointestinal disturbance, dry mouth/nose/throat, difficulty in urination or blurred vision
","Diphenhydramine has been in widespread use for many years without ill consequence. However, it is known to cross the placenta and has been detected in breast milk. Therefore, it is only used when the potential benefit of treatment to the mother exceeds any possible hazards to the developing fetus or suckling infant.
","This preparation may cause drowsiness. Caution should be exercised in patients with moderate to severe renal or hepatic dysfunction or urinary retention when using this preparation. Diphenhydramine should not be taken by individuals with narrow-angle glaucoma or symptomatic prostatic hypertrophy.
",,"The signs and symptoms of overdose may include drowsiness, hyperpyrexia and anticholinergic effects. With higher doses, CNS excitation including hallucinations and coma or cardiovascular collapse may appear. Treatment of overdose should be symptomatic and supportive, rapid gastric emptying (with Syrup of Ipecac-induced emesis or gastric lavage and activated charcoal) may be useful. Seizures may be controlled with Diazepam or Thiopental Sodium and Physostigmine IV may be efficacious to antagonise severe antichlolinergic symptoms.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+1476,Diphenhydramine + Dextromethorphan + Levomenthol,diphenhydramine-dextromethorphan-levomenthol-1476,https://medex.com.bd/attachments/v0W2OoATP6LIE1oilymejzbp7Vjgy5/diphenhydramine-dextromethorphan-levomenthol-prescribing-information,Combined cough expectorants,Dry cough,"This syrup is indicated as an antitussive, for the relief of persistent, dry, irritating cough and aids restful sleep.
","Combined cough expectorants, Combined cough suppressants
","Dextromethorphan Hydrobromide is a non-opioid antitussive drug. It exerts its antitussive activity by acting on the cough center in the medulla oblongata, raising the threshold for the cough reflex. Levomenthol has mild local anesthetic and decongestant properties. Diphenhydramine Hydrochloride possesses antitussive, antihistaminic, anticholinergic properties.
","Adults and children over 12 years: 2 teaspoonfuls of syrup 4 times a day or as directed by the physicians. Do not take more than 8 teaspoonfuls of syrup in 24 hours.
Use in children & Adolescents: The efficacy and safely of Dextromethorphan Hydrobromide have not been established in pediatric patients and adolescents.
",,"This syrup contains Diphenhydramine Hydrochloride and therefore may potentiate the effects of alcohol, and other CNS depressants. As Diphenhydramine Hydrochloride possess some anticholinergic activity, the effects of anticholinergics (e.g. some psychotrophic drugs and atropine) may be potentiated by this product. This may result in tachycardia, mouth dryness, gastrointestinal disturbances (e.g. colic), urinary retention and headache. The concomitant use of a Dextromethorphan Hydrobromide containing product and monoamine oxidase inhibitors can occasionally result in symptoms such as hyperpyrexia, hallucinations, gross excitation or coma.
","This syrup is contraindicated in individuals with known hypersensitivity to the product or any of its components. This medicine is contraindicated in individuals who are taking, or have taken, monoamine oxidase inhibitor within the preceding two weeks. Dextromethorphan, In common with other centrally acting antitussive agents, should not be given to subjects in, or at risk of developing respiratory failure.
","This syrup may cause drowsiness, dizziness, nausea, vomiting, gastrointestinal disturbance, dry mouth, nose and throat difficulty in urination, or blurred vision.
","Pregnancy: Both Diphenhydramine Hydrochloride and Dextromethorphan Hydrobromide have been in widespread use for many years without apparent ill consequences. However, there is insufficient information on the effects of the administration of Dextromethorphan Hydrobromide during human pregnancy.
Lactation: It is not known whether dextromethorphan or its metabolites are excreted in breast milk. Diphenhydramine Hydrochloride is known to cross the placenta and has also been detected in breast milk. The syrup should therefore only be used when the potential benefit of treatment to the mother exceeds any possible hazards to the developing fetus or suckling infant.
","This syrup may cause drowsiness; if affected, individuals should not drive or operate machinery. Diphenhydramine Hydrochloride should not be taken by individuals with narrow-angle glaucoma or symptomatic prostatic hypertrophy. Caution is particularly recommended for adolescents and young adults as well as in patients with a history of drug abuse or psychoactive substances.
",,"With higher doses, and particularly in children, hallucinations and convulsions may appear; with massive doses, coma or cardiovascular collapse may follow. Treatment of overdose should be symptomatic and supportive. Measures to promote rapid gastric emptying and in cases of acute poisoning the use of activated charcoal may be useful. Naloxone has been used successfully as a specific antagonist to dextromethorphan toxicity in children. Convulsions may be controlled with diazepam and thiopental sodium.
",,,"Store at a temperature not exceeding 30°C in a dry place. Protect from liqht & moisture. Keep out of the reach of children.
",11
+1839,Diltiazem Hydrochloride (SR tablet),diltiazem-hydrochloride-sr-tablet-1839,,Calcium-channel blockers,Supraventricular tachycardia,"Diltiazem Hydrochloride sustained release tablet is indicated in the prophylaxis and treatment of angina pectoris. It is used in the management of classical and vasospastic angina pectoris. It has also been used in the treatment of essential hypertension. It is used for prophylaxis of some selected supraventricular tachyarrhythmias.
","Calcium-channel blockers
","Diltiazem hydrochloride is a calcium channel antagonist. It is a peripheral and coronary vasodilator with some negative inotropic activity. Diltiazem inhibits cardiac conduction particularly at the sino-atrial and atrioventricular nodes. Diltiazem has the following actions:
Antianginal: A direct dilatation of coronary arteries and arterioles proved oxygen supply to myocardial tissues. In addition dilatation of the peripheral vasculature reduces systemic pressure of cardiac ""after load"" which results in lessened stress and reduced oxygen requirements of the myocardial tissues.
Antiarrhythmic: The inhibited influx of calcium ions in cardiac tissues result in slowed electrophysiological activity through the S-A and A-V nodes without affecting accessory bypass conduction or altering normal atrial action potential or intraventricular conduction.
Antihypertensive: Reduces peripheral vascular resistance as a result of vasodilatation. More than 90% of an oral dose is rapidly absorbed. Protein binding is very high. Peak plasma concentration reaches within 30-60 minutes. It is metabolised in the liver and excreted (60%) through bile.
","Mild to moderate hypertension: initially 90 mg or 120 mg twice daily (elderly once daily); up to 360 mg daily may be required (elderly upto 240 mg) daily.
Angina: initially 90 mg or 120 mg twice daily in divided doses may be required (elderly up to 240 mg daily).
",,"Concomitant prophylactic therapy with short-or long-acting nitrates may be administered safely during diltiazem therapy. Diltiazem recommended caution and careful dosage titration when diltiazem is administered concomitantly with other drugs that can affect cardiac contractility and/ or conduction.
","Diltiazem Hydrochloride sustained release tablet is contraindicated in patients with known hypersensitivity to the drug, sick sinus syndrome, second or third degree AV block, severe hypertension or acute myocardial infarction and rediographically documented pulmonary congestion.
","Bradycardia, sino-atrial block, atrioventricular block, hypertension, malaise, headache, hot flushes, GIT disturbances, oedema, hepatitis and depression reported.
","There are no adequate and controlled studies to date with diltiazem in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risk to the fetus. Because diltiazem is distributed into milk, women receiving the drug should not breastfeed their infants; an alternative method of infant feeding should be used if diltiazem therapy is considered necessary in nursing women.
",,,,,,"Keep medicine out of the reach of children. Store in a cool and dry place.
",9
+368,Diltiazem Hydrochloride (FC tablet),diltiazem-hydrochloride-fc-tablet-368,,Calcium-channel blockers,Tachycardia,"Diltiazem Hydrochloride film coated tablet is used for the prophylaxis and treatment of chronic stable (classical) and vasopastic angina pectoris and has also been used alone or in combination in the management of hypertension, also, Diltiazem is effective in myocardial infarction, coronary artery spasm, arrhythmias, Raynaud's phenomenon, oesophageal motility disorder and migraine.
","Calcium-channel blockers
","Diltiazem is a calcium-channel blocker with peripheral and coronary vasodilator properties. It lowers blood pressure and has some effect on cardiac conduction. Diltiazem interferes with the influx of calcium ions through the channels of active cell membranes.
","Adult: The usual dose of Diltiazem Hydrochloride film coated tablet is 60 mg thrice daily. However patient's response may vary and dosage requirements can differ significantly between individual patients. If necessary, the divided dose may be increased to 180-300 mg/day. Dosage may be started as 30 mg four times daily and increasing at 1 to 2 days intervals until the optimum response is achieved. Higher doses upto 480 mg/day have been used with benefit in some patients especially in unstable angina. Elderly and patients with impaired hepatic or renal function: The recommended starting dose is 60 mg twice daily. The heart rate should be measured regularly and the dose should not be increased if the heart rate falls below 50 beats per minute.
Children: Not recommended.
",,"Digoxin, Propranolol, Cyclosporin, Theophylline, Cimetidine, Lithium & Carbamazepine.
","Diltiazem is contraindicated to the patients of severe bradycardia, sick sinus syndrome, pregnancy, second or third degree AV block.
","With Diltiazem headache, ankle oedema, hypertension, dizziness, flushing, rashes (toxic erythema), nausea and Gl disturbances may occur. Transient elevation in liver enzyme values and occasionally hepatitis have been reported. Diltiazem may depress cardiac conduction and has occasionally led to AV block, bradycardia and rarely asystoleor sinus arrest.
",,"Diltiazem should be used with care in patients with lesser degrees of AV block or bradycardia; also in patients with impaired left ventricular function. Caution should be required in patients with impaired liver or kidney function.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+367,Diloxanide Furoate,diloxanide-furoate-367,https://medex.com.bd/attachments/fb27O9fLU3CYiwOBxzkNKqH4osliWP/diloxanide-furoate-prescribing-information,Amoebicides,Intestinal amoebiasis,"Diloxanide is indicated for intestinal amoebiasis
","Amoebicides
","Diloxanide is a luminal amoebicide which is hydrolysed in the gut, thus releasing the free diloxanide which acts as an amoebicide. It is given alone in asymptomatic cyst passers. For patients with active amoebic infections, it can be administered with a 5-nitroimidazole e.g. metronidazole or tinidazole.
","Adult: The recommended dose is 500 mg 3 times/day for 10 days. May repeat course if needed.
Child: >25 kg: 20 mg/kg daily in 3 divided doses for 10 days, repeated if necessary.
",,"There are no known drug interactions and none well documented.
","Hypersensitivity.
","The frequency of these side-effects is unknown flatulence, itching, urticaria, vomiting
","Pregnancy Category- Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
","Caution should be exercised in pregnant and breastfeeding women. Avoid excess dosage.
",,,,,,9
+366,Digoxin,digoxin-366,https://medex.com.bd/attachments/mne39l9NguIWCqZ5s787D9SbYm06cH/digoxin-oral-solution-prescribing-information,Positive Inotropic drugs,Supraventricular arrhythmias,"Digoxin is indicated in:
+
+- Heart failure.
+- Atrial fibrillation with an uncontrolled ventricular rate.
+- Acute left ventricular failure.
+- Chronic left ventricular failure and conjestive heart failure,especially when caused by hypertensive valvular (especially mitral valvular) disease or ischaemic heart disease.
+
","Positive Inotropic drugs
","Digoxin is a cardiac glycoside used in the management of particularly atrial fibrillation and in heart failure.The principal actions of digoxin are an increase in the force of myocardial contraction (positive inotropic activity and a reduction in the conductivity of the heart particularly in conduction through the atrioventricular node. Digoxin also has a direct action on vascular smooth muscle and indirect effects mediated primarily by the autonomic nervous system and particularly by an increase in vagal activity.
","By oral administration:
+
+- Rapid digitalization: 1-1.5 mg in divided doses over 24 hours
+- Less urgent digitalization: 250-500 micrograms daily (higher dose may be divided)
+- Maintenance: 62.5-500 micrograms daily (higher dose may be divided) according to renal function and in atrial fibrillation on heart rate response.
+- Usual range: 125-250 micrograms daily (lower dose may be divided) according to renal function and in atrial fibrilation on heart rate response.
+- Usual range: 125-250 micrograms daily (lower dose may be appropriate in the elderly).
+
",,"Potassium-depleting diuretics increase the effects of digitalis. Calcium particularly if administered rapidly by the intravenous route, may produce serious arrhythmia in digitalized patients. Quinidine, verapamil, amiodarone, propafenone, indomethacin, itraconazole, alprazolam, spironolactone, erythromycin, clarithromycin (and possibly other macrolide antibiotics) and tetracycline increase digoxin serum level. Besides antacids, kaolinpectin, sulfasalazine, neomycin, penicillamine, calestipol, metoclopramide, rifampin may interfere with intestinal absorption of digoxin resulting low serum concentrations of the drug.
","
+- Ventricular fibrillation.
+- Hypersensitivity to digoxin or other digitalis preparation.
+
","Usually associated with excessive dosage include anorexia, nausea, vomiting, diarrhoea, abdominal pain, visual disturbance, headache, fatigue, drowsiness, confusion, delirium, hallucination, depression, arrhythmia, heart block, intestinal ischaemia, gynaecomastia on long term use, thrombocytopenia reported. Digoxin can be safely used in pregnancy
","Digoxin is excreted in breast milk but in concentration below those found in plasma and therefore poses no hazard to the breast-fed infant.
",,"Neonates: Digoxin can be used in neonates.
Children: Digoxin can be used in children.
The elderly: Partly because of reduced renal function and partly because their tissues are more sensitive to the effects of digitalis, the elderly require a lower maintenance dose of digoxin than younger adults.
",,,,"Store in a cool and dry place.Keep out of the reach of children.
",10
+1404,Eflornithine Hydrochloride,eflornithine-hydrochloride-1404,https://medex.com.bd/attachments/aS7UlY69ulFDqlSf9xAq0qDXCgAKjJ/eflornithine-hydrochloride-prescribing-information,Hair Growth Inhibitor,Reduction of unwanted facial hair in women,"Eflornithine Hydrochloride cream, 13.9% is indicated for the reduction of unwanted facial hair in women. Eflornithine Hydrochloride has only been studied on the face and adjacent involved areas under the chin of affected individuals. Usage should be limited to these areas of involvement.
","Hair Growth Inhibitor
","Eflornithine prevents hair growth by inhibiting the anagen phase of hair production. This occurs by eflornithine irreversibly binding (also called suicide inhibition) to ornithine decarboxylase (ODC) and physically preventing the natural substrate ornithine from accessing the active site.
","Adults: Apply a thin layer of Eflornithine cream, 13.9% to affected areas of the face and adjacent involved areas under the chin and rub in thoroughly. Do not wash treated area for at least 4 hours. Use twice daily at least 8 hours apart or as directed by a physician. The patient should continue to use hair removal techniques as needed in conjunction with Eflornithine (Wonica should be applied at least 5 minutes after hair removal). Cosmetics or sunscreens may be applied over treated areas after cream has dried.
Elderly: No apparent differences in safety were observed between older patients and younger patients.
Children: The safety and effectiveness of this product have not been established in pediatric patients less than 12 years of age.
",,"It is not known whether Eflornithine has any interaction with other topically applied drug products.
","Eflornithine is contraindicated in patients with a history of sensitivity to any components of the preparation.
","Adverse events were primarily mild in intensity and generally resolved without medical treatment or discontinuation of Eflornithine. Side effects can include acne, barbae, pseudofolliculitis, stinging skin, headache, burning skin, dry skin, erythema (redness), pruritus (itching), tingling skin, dyspepsia, skin irritation, rash, alopecia, dizziness, folliculitis, hair ingrown, facial edema, anorexia, nausea, asthenia, vertigo
","Pregnancy Category C. It is not known whether or not Eflornithine Hydrochloride is excreted in human milk. Caution should be exercised when Eflornithine is administered to a nursing woman.
","For external use only. Transient stinging or burning may occur when applied to abraded or broken skin.
",,"Overdosage information with Eflornithine is unavailable. However, if very high topical doses (e.g., multiple tubes per day) or oral ingestion has been encountered (a 30 gm tube contains 4.2 gm of Eflornithine Hydrochloride), the patient should be monitored, and appropriate supportive measures should be administered as necessary.
",,,"Store at 25°C, excursions permitted to 15°C-30°C. Do not freeze.
",11
+404,Efavirenz,efavirenz-404,https://medex.com.bd/attachments/jI1f1PlsyNjRI9xs6RFAWTRr7YZAkE/efavirenz-prescribing-information,Drugs for HIV / Anti-retroviral drugs,HIV infection,"Efavirenz in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection. This indication is based on analyses of plasma HIV- RNA levels and CD4 cell counts in controlled studies of up to 24 weeks in duration. At present, there are no results from controlled trials evaluating long term suppression of HIVRNA with Efavirenz.
","Drugs for HIV / Anti-retroviral drugs
","Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) with activity against HIV-1. It blocks the RNA- and DNA-dependent polymerase activities including HIV-1 replication.
","Adults: The recommended dosage of Efavirenz is 600 mg orally, once daily, in combination with a protease inhibitor and/or nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Pediatric Patients: Following table describes the recommended dose of Efavirenz for pediatric patients 3 years of age or older and weighing between 10 and 40 kg. The recommended dosage of Efavirenz for pediatric patients weighing greater than 40 kg is 600 mg, once daily.
+
+- 10 to <15 kg: 200 mg
+- 15 to < 20 kg: 250 mg
+- 20 to < 25 kg: 300 mg
+- 25 to < 32.5 kg: 350 mg
+- 32.5 to < 40 kg: 400 mg
+- 40 kg: 600 mg
+
","It is recommended that Efavirenz be taken on an empty stomach, preferably at bedtime.
","Additive CNS effects w/ psychoactive drugs. May alter plasma warfarin concentrations. May reduce plasma concentrations of HIV integrase inhibitors (e.g. dolutegravir), other HIV NNRTIs (e.g. etravirine), HMG-CoA reductase inhibitors (e.g. simvastatin). Plasma concentrations of efavirenz is increased and that of voriconazole is reduced when given concomitantly. Reduced plasma concentrations w/ rifampicin.
","Hypersensitivity. Severe hepatic impairment. Lactation. Concomitant admin with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, ergot alkaloids, St John’s wort.
","Rashes, psychiatric or CNS disturbances, amnesia, agitation, confusion, dizziness, vertigo, headache, euphoria, insomnia or somnolence, impaired concentration, abnormal thinking or dreaming, depersonalisation, convulsions, hallucinations, nausea, vomiting, diarrhoea, pancreatitis, fatigue, hepatic failure, photoallergic dermatitis; autoimmune disorders (e.g. Graves’ disease, polymyositis, Guillain-Barre syndrome), osteonecrosis. Accumulation or redistribution of body fat (lipodystrophy) including central obesity, peripheral and facial wasting, buffalo hump, breast enlargement, cushingoid appearance. Metabolic abnormalities e.g. hypercholesterolaemia, hyperglycaemia, hypertriglyceridaemia, hyperlactataemia, insulin resistance.
","Category D: There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Lactation: Efavirenz may pass through breast milk and cause serious harm to the baby. It should not be used during lactation.
","Patient with history of seizures and psychiatric disorders; acute porphyria. Patients receiving voriconazole or rifampicin (weighing ≥50 kg). Discontinue if severe rash or fever develops. Moderate hepatic and severe renal impairment. Childn. Pregnancy.
","Paediatric use: Efavirenz has not been studied in pediatric patients below 3 years of age or who weigh less than 10 kg.
Women taking hormone-based birth control: Women should not rely only on hormone-based birth control, such as pills, injections, or implants, because Efavirenz may make these contraceptives ineffective.
","Symptoms: Increased adverse CNS effects including involuntary muscle contractions.
Management: Supportive and symptomatic treatment. May administer activated charcoal.
",,,"Store at 25°C.
",13
+403,Econazole Nitrate + Triamcinolone Acetonide,econazole-nitrate-triamcinolone-acetonide-403,https://medex.com.bd/attachments/SuSro89criE3I9wdQfJeuZ8LQDeaH4/econazole-nitrate-triamcinolone-acetonide-prescribing-information,Triamcinolone & Combined preparations,Tinea corporis (ringworm),"Econazole Nitrate & Triamcinolone Acetonide indicated for the treatment of:
+
+- Eczematous Mycoses
+- Psoriasis
+- Tinea Pedis (Athlete’s foot)
+- Tinea Corporis (Ring worm)
+- Tinea Cruris (Jock itch)
+- Inflammatory Intertrigo
+- Diaper Dermatitis
... Read more
Econazole Nitrate & Triamcinolone Acetonide indicated for the treatment of:
+
+- Eczematous Mycoses
+- Psoriasis
+- Tinea Pedis (Athlete’s foot)
+- Tinea Corporis (Ring worm)
+- Tinea Cruris (Jock itch)
+- Inflammatory Intertrigo
+- Diaper Dermatitis
+
+Onychomycoses- for the treatment of onychomycoses, local therapy with Econazole/Triamcinolone cream, combined with an oral antimycotic, is recommended.
","Triamcinolone & Combined preparations
",,"Adults: This cream should be applied sparingly to the skin lesion no more than 2 times daily, preferably once in the morning and once in the evening. This cream should not be applied with an occlusive dressing, or to large areas of skin on the body. The duration of treatment with this cream should continue until the inflammatory symptoms subside but not longer than 2 weeks; after 2 weeks of therapy with this cream, continue therapy as needed with a preparation containing econazole or econazole nitrate alone.
Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight. Caution should be exercised.
",,"Econazole: compound metabolized by CYP3A4/2C9 oral anticoagulants (warfarin & acenocoumarol).
Triamcinolone: lowering of plasma salicylates levels. Increased risk of Gl bleeding and ulceration with NSAIDs. Antagonised blood glucose-lowering effects of the antidiabetics. Increased risk of Hyperkalemia with amphotericin B, beta-blockers, potassium-depleting diuretics, theophylline. Increased clearance of the triamcinolone with ciclosporin, carbamazepine, phenytoin, barbiturate, rifampicin.
","This Cream is contraindicated-
+
+- In individuals who have shown hypersensitivity to any of its ingredients.
+- Like any other dermatological preparation containing corticosteroids, this Cream is contraindicated in specific skin conditions such as tuberculous, varicella, herpes simplex or other viral infections of the skin, or fresh vaccination sites.
+- Decubitus ulcers: Viral, bacterial or fungal skin infections (e.g. tuberculosis of the skin, syphilis of the skin, herpes simplex, herpes zoster, chickenpox).
+- Rosacea and rosacea-like dermatitis.
+
","Rarely, transient local mild irritation, itching & redness may occur immediately after application. Econazole has the minimal allergenic effect and is well tolerated, even by delicate skin. Adrenal suppression on long term continuous topical steroid therapy may occur, particularly in infants or children, or when occlusive dressings are applied. It should be noted that an infant's napkin may act as an occlusive dressing.
","Pregnancy: Not the Econazole but the Triamcinolone Acetonide crosses the placenta and topical administration of corticosteroids during pregnancy can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established. However, topical steroids in large amounts or for prolonged periods
should not be used in pregnancy.
Lactation: Negligible amount of econazole and to some extent Triamcinolone may be excreted in small amounts in breast milk. So this cream should not be prescribed to the lactating mother or if prescribed lactation should be withheld during treatment.
","
+- For external use only. This Cream is not for ophthalmic or oral use.
+- If a reaction suggesting hypersensitivity or chemical irritation should occur, use of the medication should be discontinued.
+- Corticosteroids applied to the skin can be absorbed in sufficient amounts to produce systemic effects, including adrenal suppression. Systemic absorption may be increased by various factors such as application over a large skin surface area, application to damaged skin, application under occlusive skin dressings and prolonged duration of therapy.
+- Topical corticosteroids are associated with skin thinning and atrophy, striae, telangiectasis and purpura.
+- Topical corticosteroids may lead to increased risk of dermatological superinfection or opportunistic infection.
+
+
Children: Increased caution is required when treating children. Compared to adults, the nature of a child's skin and the larger skin surface area relative to body weight may lead to an increased absorption of the corticosteroid via the child's skin. This cream should be used in children only for short periods of time (less than 2 weeks) and on small areas (less than 10% of body surface area).
Visual disturbance may be associated with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR).
",,"This Cream is for cutaneous application only. Corticosteroids applied to the skin, including triamcinolone, can be absorbed in sufficient amounts to produce systemic effects. In the event of accidental ingestion, treat symptomatically. If this cream is accidentally applied to the eyes, wash with clean water or saline and seek medical attention if symptoms persist.
",,,"Store in a cool (below 30°C) and dry place, away from light. Keep out of the reach of children.
",10
+402,Econazole Nitrate,econazole-nitrate-402,https://medex.com.bd/attachments/xRLxRXwYFJmPy8PKdODS7e82FZLZuk/econazole-nitrate-cream-prescribing-information,Topical Antifungal preparations,Vulvovaginal candidiasis,"Econazole Nitrate is indicated for topical application-
+
+- In the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum,
... Read more
Econazole Nitrate is indicated for topical application-
+
+- In the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum,
+- In the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.
+
","Drugs used in Vaginal and Vulval condition, Topical Antifungal preparations
","Econazole Nitrate interferes with fungal oxidative enzymes to cause lethal accumulation of H2O2. They also reduce the formation of ergosterol, an important constituent of fungal cell wall.
","Econazole vaginal tablet: One tablet should be inserted deep into the vagina at bed time for three consecutive nights. Treatment should be continued even if menstruation occurs. Although a three night course of treatment is often sufficient longer courses are advisable for women with recurrent vaginal infections.
Econazole 30 gm cream: The supplied applicator should be filled with econazole cream and then inserted deep into the vagina at bedtime once or twice daily.
Econazole 10 gm cream: Apply sparingly to the affected area once or twice daily until improvement occurs.
Sufficient Econazole cream should be applied to cover affected areas once daily in patients with tinea pedis, tinea cruris, tinea corporis, and tinea versicolor, and twice daily (morning and evening) in patients with cutaneous candidiasis. Early relief of symptoms is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks and tinea pedis for one month in order to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.
",,"Warfarin: Concomitant administration of econazole and warfarin has resulted in enhancement of anticoagulation effect. Most cases reported product application with use under occlusion, genital application, or application to large body surface area which may increase the systemic absorption of econzole nitrate. Monitoring of International Normalized Ratio (INR) and/or prothrombin time may be indicated especially for patients who apply econazole to large body surface areas, in the genital area, or under occlusion.
Carcinogenicity Studies: Long-term animal studies to determine carcinogenic potential have not been performed.
","Econazole is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.
","During clinical trials, approximately 3% of patients treated with econazole nitrate 1% cream reported side
effects thought possibly to be due to the drug, consisting mainly of burning, itching, stinging, and erythema. One case of a pruritic rash has also been reported.
","Intravaginal administration in humans has not shown prolonged gestation or other adverse reproductive effects attributable to econazole nitrate therapy.
Pregnancy Category C. Econazole nitrate should be used in the first trimester of pregnancy only when the physician considers it essential to the welfare of the patient. The drug should be used during the second and third trimesters of pregnancy only if clearly needed.
It is not known whether econazole nitrate is excreted in human milk. Caution should be exercised when econazole nitrate is administered to a nursing woman.
","Econazole nitrate is not for ophthalmic use. If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued. For external use only. Avoid introduction of Econazole Nitrate Cream into the eyes.
",,"Overdosage of econazole nitrate in humans has not been reported to date.
",,,"Do not use later than date of expiry. Keep all medicine out of the reach of children. To be dispensed only on the prescription of a registered physician.
",11
+401,Ebastine,ebastine-401,https://medex.com.bd/attachments/EPGCRsu5GWMQ4l7aaYcgrrgox40sga/ebastine-film-coated-tablets-prescribing-information,Non-sedating antihistamines,Urticaria,"Ebastine is indicated for the symptomatic treatment of:
+
+- Seasonal and Perennial Allergic Rhinitis.
+- Chronic Idiopathic Urticaria.
+
","Non-sedating antihistamines
","Ebastine is a long-acting and selective H1-histamine receptor antagonist. After repeated administration, inhibition of peripheral receptors remains at a constant level. Ebastine is rapidly absorbed and undergoes extensive first-pass metabolism following oral administration. Ebastine is almost totally converted to the pharmacologically active acid metabolite, carebastine.
","Tablet:
+
+- Adults (more than 12 years of age): 10 mg (one tablet) once daily.
+- Children (6-12 years of age): 5 mg (half tablet) once daily.
+
+Syrup:
+
+- Children (2-5 years of age): 2.5 ml once daily (upto 5 ml in severe cases such as Perennial Allergic Rhinitis).
+- Children (6-12 years of age): 5 ml once daily (upto 10 ml in severe cases such as Perennial Allergic Rhinitis).
+
+Ebastine may be taken with or without food.
",,"Ebastine in combination with either ketoconazole or erythromycin increases in plasma level of ebastine and prolonged QTc interval. Ebastine does not interact with the pharmacokinetics of theophylline, warfarin, cimetidine, diazepam or alcohol. The sedation effect of alcohol and diazepam may be enhanced.
","Patients with a known hypersensitivity to Ebastine or any of its ingredients.
","The most common side-effects are headache, dry mouth and drowsiness. Less commonly reported side effects include abdominal pain, dyspepsia, nausea and insomnia.
",,,,"No clinically meaningful signs or symptoms were observed up to 100 mg given once daily. There is no specific antidote for Ebastine. In case of accidental overdoses, gastric lavage, monitoring of vital functions including ECG and symptomatic treatment should be carried out.
",,,"Store below 30°C at a cool and dry place, away from light. Keep out of reach of children
",9
+400,Dydrogesterone,dydrogesterone-400,https://medex.com.bd/attachments/4acIy8zXirOfiwltno8zEgQqOCsN1Q/dydrogesterone-prescribing-information,Female Sex hormones,Uterine bleeding,"Progesterone deficiencies:
+
+- Treatment of threatened miscarriage
+- Treatment of habitual miscarriage
+- Treatment of dysmenorrhoea
+- Treatment of endometriosis
+- Treatment of secondary amenorrhoea
+- Treatment of irregular cycles
+- Treatment of dysfunctional uterine bleeding
... Read more
Progesterone deficiencies:
+
+- Treatment of threatened miscarriage
+- Treatment of habitual miscarriage
+- Treatment of dysmenorrhoea
+- Treatment of endometriosis
+- Treatment of secondary amenorrhoea
+- Treatment of irregular cycles
+- Treatment of dysfunctional uterine bleeding
+- Treatment of infertility due to luteal insufficiency
+- Luteal support as part of an Assisted Reproductive Technology (ART)
+
+
Hormone Replacement Therapy: To counteract the effects of unopposed oestrogen on the endometrium in hormone replacement therapy for women with disorders due to natural or surgical induced menopause with an intact uterus.
","Female Sex hormones
","Dydrogesterone is an orally-active progestogen which produces a complete secretory endometrium in an oestrogen-primed uterus thereby providing protection against the increased risk for endometrium hyperplasia and carcinogenesis induced by oestrogens. It is indicated in all cases of endogenous progesterone deficiency. Dydrogesterone has no oestrogenic, no androgenic, no thermogenic, no anabolic and no corticoid activity.
","Always take Presentation 10 mg tablet exactly as your doctor has prescribed.
Presentationerone deficiencies:
+
+- Threatened miscarriage: 40 mg (four tablets) at once, then 10 mg (one tablet) every eight hours until symptoms remit.
+- Habitual miscarriage: 10 mg (one tablet) twice daily until the twentieth week of pregnancy.
+- Dysmenorrhoea: 10 mg (one tablet) twice daily from day 5 to day 25 of the menstrual cycle.
+- Endometriosis: 10 mg (one tablet) two or three times daily from day 5 to day 25 of the cycle or continuously.
+- Dysfunctional bleeding (to arrest bleeding): 10 mg (one tablet) twice daily for five to seven days. Presentation should be given with oestrogen.
+- Dysfunctional bleeding (to prevent bleeding): 10 mg (one tablet) twice daily from day 11 to day 25 of the cycle. Presentation should be given with oestrogen.
+- Amenorrhoea: An oestrogen once daily from day 1 to day 25 of the cycle, together with 10 mg Presentation twice daily from day 11 to day 25 of the cycle.
+- Irregular cycles: 10 mg (one tablet) twice daily from day 11 to day 25 of the cycle.
+- Infertility due to luteal insufficiency: 10 mg (one tablet) daily from day 14 to day 25 of the cycle. The treatment should be continued for at least 6 consecutive cycles. It is advisable to continue this treatment during the first month of any pregnancy using the doses stated with respect to habitual miscarriage.
+- Luteal support as part of an Assisted Reproductive Technology (ART) treatment: 10 mg three times daily (three tablets daily) starting at the day of oocyte retrieval and continuing for 10 weeks if pregnancy is confirmed.
+
+
Hormone Replacement Therapy: In combination with continuous oestrogentherapy, take one tablet daily for 14 consecutive days of a 28 day cycle. In combination with cyclical oestrogen therapy take one tablet daily during the last 12 to 14 days of oestrogen therapy. For doctors: If endometrial biopsies or ultrasound reveal inadequate Presentationational response, 20 mg Dydrogesterone should be prescribed. For patients: If you are not sure what type of oestrogen therapy you are on, talk to your Doctor before taking Presentation. There is no relevant use of Dydrogesterone before menarche. The safety and efficacy of Dydrogesterone in adolescents aged 12 to 18 years has not been established.
",,,"Known hypersensitivity to the active substance or to any of the excipients. Known or suspected progestogen dependent neoplasms (e.g. meningioma).
","The most commonly reported adverse drug reactions of patients treated with Dydrogesterone in clinical trials of indications without oestrogen treatment are migraines/headache, nausea, menstrual disorders and breast pain/tenderness.
","It is estimated that more than 10 million pregnancies have been exposed to Dydrogesterone. So far there were no indications of a harmful effect of Dydrogesterone use during pregnancy. No data exist on excretion of Dydrogesterone in mother's milk. Experience with other progestogens indicates that progestogens and the metabolites pass to mother's milk in small quantities. Whether there is a risk to the child is not known. Therefore Dydrogesterone should not be used during the lactation period.
","Before initiating dydrogesterone treatment for abnormal bleeding the etiology for the bleeding should be clarified. Breakthrough bleeding and spotting may occur during the first months of treatment. If breakthrough bleeding or spotting appears after some time on therapy, or continues after treatment has been discontinued, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy. If one of the following disorders occurs during use for the first time or gets worse, stopping the treatment should be considered.
+
+- Severe headache, migraine or symptoms that may indicate cerebral ischemia.
+- Marked increase in blood pressure.
+- Occurrence of venous thromboembolism (VTE)
+
+In cases of habitual or threatened abortion, the viability of the foetus should be ascertained. It is also necessary to monitor during treatment whether the pregnancy is still progressing and whether the embryo is still alive. Patients with a history of depression must be carefully monitored; if severe depression recurs, treatment with dydrogesterone must be stopped
",,"Dydrogesterone was well tolerated after oral dosing (maximum daily dose is 360 mg). No reports of ill effects from overdose have been recorded. If a large overdose is discovered within two or three hours and treatment seems desirable, gastric lavage is recommended. There are no specific antidotes and treatment should be symptomatic.
",,,"Store at below 30°C in a dry place protected from light. Keep out of reach of children.
",10
+399,Dutasteride,dutasteride-399,https://medex.com.bd/attachments/4wGRIOUjlvuOtOuBlmeZ222cuI9C0K/dutasteride-prescribing-information,BPH/ Urinary retention/ Urinary incontinence,Benign prostatic hyperplasia (BPH),"Dutasteride is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
+
+- Improve symptoms
+- Reduce the risk of acute urinary retention
+- Reduce the risk of the need for BPH-related surgery
+
","BPH/ Urinary retention/ Urinary incontinence
","Dutasteride is a dual inhibitor of 5α-reductase. It inhibits both type 1 and type 2, 5α-reductase isoenzymes, which are responsible for the conversion of testosterone to 5α-dihydrotestosterone (DHT). DHT is the androgen primarily responsible for hyperplasia of glandular prostatic tissue.
","The recommended dose is Dutasteride 0.5 mg orally once daily. The capsules should be swallowed whole. Dutasteride may be administered with or without food.
",,"Care should be taken when administering Dutasteride to patients taking potent, chronic CYP3A4 inhibitors. Dutasteride does not inhibit the in vitro metabolism of model substrates for the major human cytochrome P450 isoenzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) at a concentration of 1,000 ng/ml, 25 times greater than steady-state serum concentrations in humans. In vitro studies demonstrate that Dutasteride does not displace Warfarin, Diazepam, or Phenytoin from plasma protein binding sites, nor do these model compounds displace Dutasteride.
","Dutasteride is contra-indicated for use in women and children and for patients with known hypersensitivity to Dutasteride, and other 5 a-reductase inhibitors. Warnings: Exposure of women-risk to male fetus: Dutasteride is absorbed through the skin. Therefore, women who are pregnant or may be pregnant should not handle Dutasteride capsules because of the possibility of absorption of Dutasteride and the potential risk of a fetal anomaly to a male fetus. If contact is made with leaking capsules, the contact area should be washed immediately with soap and water.
","
+- Sexual problems (such as decreased sexual interest/ ability, decrease in the amount of semen/ sperm released during sex)
+- Impotence (trouble getting or keeping an erection)
+- Testicle pain or swelling
+- Increased breast size
+- Breast tenderness.
+
","Pregnancy Category X. Dutasteride is contraindicated for use in women.
","Lower urinary tract symptoms of BPH can be indicative of other urological diseases, including prostate cancer. Patients should be assessed to rule out other urological diseases prior to treatment with Dutasteride. Patients with a large residual urinary volume and/or severely diminished urinary flow may not be good candidates for 5 a-reductase inhibitor therapy and should be carefully monitored for obstructive uropathy. Blood Donation: Men being treated with Dutasteride should not donate blood until at least 6 months have passed following their last dose. The purpose of this deferred period is to prevent administration of Dutasteride to a pregnant female transfusion recipient.
","Pediatric use: Dutasteride is not indicated for use in the pediatric population. Safety and effectiveness in the pediatric population have not been established.
Geriatric use: No overall differences in safety or efficacy were observed between elderly and adult subjects.
Elderly use: No dosage adjustment is necessary for subjects with renal impairment or for the elderly.
Hepatic impairment: Due to the absence of data in patients with hepatic impairment, no dosage recommendation can be made.
","In volunteer studies, single doses of Dutasteride up to 40 mg (80 times the therapeutic dose) for 7 days have been administered without significant safety concerns. In a clinical study, daily doses of 5 mg (10 times the therapeutic dose) were administered to 60 subjects for 6 months with no additional adverse effects to those seen at therapeutic doses of 0.5 mg. There is no specific antidote for Dutasteride. Therefore, in cases of suspected overdosage symptomatic and supportive treatment should be given as appropriate, taking the long half-life of Dutasteride into consideration.
",,,"Store in a cool and dry place, protected from light
",12
+398,Duloxetine Hydrochloride,duloxetine-hydrochloride-398,https://medex.com.bd/attachments/ZA5SJBsSIW2YfPeR4BFnW7fPexoSt7/duloxetine-hydrochloride-prescribing-information,Serotonin-norepinephrine reuptake inhibitor (SNRI),Urinary incontinence,"Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for-
+
+- Major Depressive Disorder (MDD)
+- Generalized Anxiety Disorder (GAD)
+- Diabetic Peripheral Neuropathic Pain (DPNP)
+- Fibromyalgia and
+- Chronic Musculoskeletal Pain.
+
","Serotonin-norepinephrine reuptake inhibitor (SNRI)
","Duloxetine Hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Duloxetine is a less potent inhibitor of dopamine reuptake. Duloxetine has no significant affinity for dopaminergic, adrenergic, cholinergic, histaminergic, opioid, glutamate, and GABA receptors in vitro. Duloxetine does not inhibit monoamine oxidase (MAO). Orally administered Duloxetine hydrochloride is well absorbed. Elimination of Duloxetine is mainly through hepatic metabolism.
","Major Depressive Disorder (MDD)-
+
+- Starting Dose: 40 mg/day to 60 mg/day
+- Target Dose: Acute: 40 mg/day (20 mg twice daily) to 60 mg/day (once daily or as 30 mg twice daily); Maintenance: 60 mg/day
+- Maximum Dose: 120 mg/day
+
+Generalized Anxiety Disorder (GAD)-
+
+- Starting Dose: 60 mg/day
+- Target Dose: 60 mg/day (once daily)
+- Maximum Dose: 120 mg/day
+
+Diabetic Peripheral Neuropathic Pain (DPNP)-
+
+- Starting Dose: 60 mg/day
+- Target Dose: 60 mg/day (once daily)
+- Maximum Dose: 60 mg/day
+
+Fibromyalgia-
+
+- Starting Dose: 30 mg/day
+- Target Dose: 60 mg/day (once daily)
+- Maximum Dose: 60 mg/day
+
+Chronic Musculoskeletal Pain-
+
+- Starting Dose: 30 mg/day
+- Target Dose: 60 mg/day (once daily)
+- Maximum Dose: 60 mg/day
+
+Some patients may benefit from starting at 30 mg once daily. There is no evidence that doses greater than 60 mg/day confers an additional benefit, while some adverse reactions were observed to be dose-dependent. A gradual dose reduction is recommended to avoid discontinuation symptoms.
",,"Both CYP1A2 and CYP2D6 isozymes are responsible for Duloxetine metabolism. When Duloxetine was co-administered with fluvoxamine, a potent CYP1A2 inhibitor, the AUC, Cmax and t of Duloxetine was increased. Other drugs that inhibit CYP1A2 metabolism include cimetidine and quinolone antimicrobials such as ciprofloxacin and enoxacin would be expected to have similar effects and these combinations should be avoided. Because CYP2D6 is involved in Duloxetine metabolism, concomitant use of Duloxetine with potent inhibitors of CYP2D6 may result in higher concentrations of Duloxetine.
","Duloxetine is contraindicated in patients with a known hypersensitivity to this drug or any of the inactive ingredients. Duloxetine is not approved for use in treating bipolar depression. Duloxetine should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease. In clinical trials, Duloxetine was associated with an increased risk of mydriasis; therefore, it should be used cautiously in patients with controlled narrow-angle glaucoma.
","The most commonly observed adverse events in Duloxetine hydrochloride treated patients were nausea, dizziness, dry mouth, constipation, decreased appetite, fatigue, somnolence, increased sweating, hyperhidrosis and asthenia. It may slightly increase blood pressure. No clinically significant differences were observed for QT, PR, and QRS intervals between Duloxetine-treated and placebo-treated patients.
","Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women; therefore, Duloxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Labor and Delivery: The effect of Duloxetine on labor and delivery in humans is unknown. Duloxetine should be used during labor and delivery only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is unknown whether or not Duloxetine and/or it's metabolites are excreted into human milk, but nursing while on Duloxetine is not recommended
","All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes. Blood pressure should be measured prior to initiating treatment and periodically measured throughout treatment. Patients should be cautioned about the risk of bleeding associated with the concomitant use of Duloxetine and NSAIDs, aspirin, or other drugs that affect coagulation. Duloxetine should be used cautiously in patients with a history of mania. Duloxetine should be prescribed with care in patients with a history of a seizure disorder.
","Use in the pediatric population: Safety and efficacy in pediatric patients have not been established
","There is limited clinical experience with Duloxetine overdose in humans. There is no specific antidote to Duloxetine. In case of acute overdose, treatment should consist of those general measures employed in the management of overdose with any drug. An adequate airway, oxygenation, and ventilation should be assured, and cardiac rhythm and vital signs should be monitored. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion or in symptomatic patients. Activated charcoal may be useful in limiting the absorption of Duloxetine from the gastrointestinal tract.
",,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",12
+1599,Dulaglutide,dulaglutide-1599,https://medex.com.bd/attachments/f8jBV2B1QSmjOSIQo9Bev1uTNekaaU/dulaglutide-prescribing-information,GLP-1 receptor agonists,Type 2 DM,"Dulaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated:
+
+- As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
+- To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.
+
","GLP-1 receptor agonists
","Dulaglutide contains dulaglutide, which is a human GLP-1 receptor agonist with 90% amino acid sequence homology to endogenous human GLP-1 (7-37). Dulaglutide activates the GLP-1 receptor, a membrane-bound cell-surface receptor coupled to adenylyl cyclase in pancreatic beta cells. Dulaglutide increases intracellular cyclic AMP (cAMP) in beta cells leading to glucose-dependent insulin release. Dulaglutide also decreases glucagon secretion and slows gastric emptying.
","The recommended initiating dose of Dulaglutide is 0.75 mg once weekly. The dose may be increased to 1.5 mg once weekly for additional glycemic control. The maximum recommended dose is 1.5 mg once weekly. Administer Dulaglutide once weekly, any time of day, with or without food. Dulaglutide should be injected subcutaneously in the abdomen, thigh, or upper arm.
If a dose is missed, instruct patients to administer as soon as possible if there are at least 3 days (72 hours) until the next scheduled dose. If less than 3 days remain before the next scheduled dose, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule. The day of weekly administration can be changed if necessary as long as the last dose was administered 3 or more days before.
",,"Dulaglutide slows gastric emptying and thus has the potential to reduce the rate of absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with Dulaglutide. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with Dulaglutide. In clinical pharmacology studies, Dulaglutide did not affect the absorption of the tested, orally administered medications to a clinically relevant degree.
","Dulaglutide is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2. Dulaglutide is contraindicated in patients with a prior serious hypersensitivity reaction to Dulaglutide or any of the product components.
","The most common adverse reactions, reported in ≥5% of patients treated with Dulaglutide are: nausea, diarrhea, vomiting, abdominal pain, and decreased appetite
","Dulaglutide should be used during pregnancy only if the potential benefit justifies the potential risk to fetus. There are no data on the presence of dulaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. The presence of dulaglutide in milk of treated lactating animals was not determined. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Dulaglutide and any potential adverse effects on the breastfed infant from Dulaglutide or from the underlying maternal condition.
","Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapies in patients with history of pancreatitis.
Hypoglycemia: When Dulaglutide is used with an insulin secretagogue (e.g., a sulfonylurea) or insulin, consider lowering the dose of the sulfonylurea or insulin to reduce the risk of hypoglycemia.
Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) have occurred. Discontinue Dulaglutide and promptly seek medical advice.
Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.
Severe Gastrointestinal Disease: Use may be associated with gastrointestinal adverse reactions, sometimes severe. Has not been studied in patients with severe gastrointestinal disease and is not recommended in these patients.
Diabetic Retinopathy Complications: Have been reported in a cardiovascular outcomes trial. Monitor patients with a history of diabetic retinopathy.
","Pediatric Use: Safety and effectiveness of Dulaglutide have not been established in pediatric patients. Dulaglutide is not recommended for use in pediatric patients younger than 18 years.
Hepatic Impairment: There is limited clinical experience in patients with mild, moderate, or severe hepatic impairment. Therefore, Dulaglutide should be used with caution in these patient populations.
Renal Impairment: No dosage adjustment recommended. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.
","Overdoses have been reported in clinical studies. Effects associated with these overdoses were primarily mild or moderate gastrointestinal events (e.g., nausea, vomiting) and non-severe hypoglycemia. In the event of overdose, appropriate supportive care (including frequent plasma glucose monitoring) should be initiated according to the patient’s clinical signs and symptoms.
",,,"Store Dulaglutide in the refrigerator at 2°C to 8°C. Do not use Dulaglutide beyond the expiration date. If needed, each single-dose pen can be kept at room temperature, not to exceed 30°C for a total of 14 days. Do not freeze Dulaglutide.
",12
+397,Drotaverine,drotaverine-397,,Anticholinergics,Tetanus,"Spastic conditions of the gastrointestinal tract, irritable bowel syndrome-
+
+- Biliary colics and spastic conditions of the biliary tract: Cholecystolithiasis, cholecystitis, cholangitis.
+- Renal colics and spastic conditions of the urogenital tract: Nephrolithiasis, ureterolithiasis, pyelitis, cystitis.
... Read more
Spastic conditions of the gastrointestinal tract, irritable bowel syndrome-
+
+- Biliary colics and spastic conditions of the biliary tract: Cholecystolithiasis, cholecystitis, cholangitis.
+- Renal colics and spastic conditions of the urogenital tract: Nephrolithiasis, ureterolithiasis, pyelitis, cystitis.
+- Spastic conditions of the uterus: Dysmenorrhea, imminent abortion, uterine tetanus.
+
","Anticholinergics
","Drotaverine has antispasmodic effect mediated via inhibition of phosphodiesterase-IV, specific for smooth muscle. It has a rapid and direct action on the smooth muscle. It acts to correct cyclic AMP and Ca imbalance at the spastic site, thereby relieving smooth muscle spasm and pain.
","Oral-
+
+- Adults: 1 to 2 tablets, 3 times daily
+- Children (over 6 years): 1/2 to 1 tablet, 1-2 times daily.
+- Children (1-6 years): 1/4 to 1/2 tablet, 1-2 times daily.
+
+Injection-
+
+- Adults: 1 to 2 ampoules, intramuscularly or subcutaneously, 1-3 times daily.
+- For the management of acute stone colics: 1 or 2 ampoules by slow intravenous injection.
+
",,"May attenuate the action of levodopa. Concurrent use of analgesics, antimuscarinics or benzodiazepines. Additive beneficial effect with concurrent use of analgesics, antimuscarinics or benzodiazepines.
","Drotaverine is contraindicated in patients with known hypersensitivity to the products and its constituents.
","The common side effects are headache, dizziness, rhinitis, sinusitis, gastrointestinal upset, nausea, pharyngitis, edema and fatigue.
","As with most drugs, the use of Drotaverine Hydrochloride should be avoided during pregnancy and lactation unless essential.
","Caution should be taken for patients suffering from liver and kidney disease.
",,,,,,9
+1663,Drospirenone,drospirenone-1663,https://medex.com.bd/attachments/8v0EQXOZGzv31blqNEcmmGIgdka9jP/drospirenone-prescribing-information,Oral Contraceptive preparations,Oral contraceptives,"Drospirenone is indicated for oral contraception.
","Oral Contraceptive preparations
","Drospirenone is a Progestin-only pill which is a synthetic form of progesterone. The hormonal component of Drospi inhibit ovulation by Suppressing gonadotropin release, Secondary mechanisms, which may contribute to the effectiveness of Drospi as a contraceptive, include changes in the cervical mucus (which increase the difficulty of sperm penetration) and changes in the endometrium (which reduce the likelihood of implantation). Drospirenone has antimineralocorticoid activity, counteracting oestrogen related sodium retention. Drospirenone exerts antiandrogenic activity.
","Drospirenone (white active and light pink inert tablets) is swallowed whole once a day. Take one tablet daily for 28 consecutive days; one white active tablet daily during the first 24 days and one light pink inert tablet daily during the 4 following days. Tablets must be taken every day at about the same time of the day so that the interval between two tablets is always 24 hours.
",,"Drugs or herbal products that induce certain enzymes (for example, CYP3A4) may decrease the effectiveness of Drospirenone or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with Drospirenone.
","
+- Renal impairment
+- Adrenal insufficiency
+- Presence or history of progestin sensitive cancers
+- Liver tumors, benign or malignant, or hepatic impairment
+- Undiagnosed abnormal uterine bleeding
+
","The following clinically significant Side Effects are described elsewhere in other sections of the labeling:
+
+- Hyperkalemia
+- Bleeding Irregularities and Amenorrhea
+- Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
+
",,"Before you take Drospirenone, do not take this medicine and tell your doctor if you are already taking the following medicines: efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, rifabutin, rufinamide, aprepitant, products containing St. John's wort. Take special care while taking Drospirenone Hyperkalemia Thromboembolic Disorders, Bone Loss, Liver Disease Ectopic Pregnancy, Risk of Hyperglycemia in Patients with Diabetes, Bleeding Irregularities, and Amenorrhea, Depression.
",,,,,"Store below 30°C and dry place. Keep away from light. Keep out of the reach of children.
",9
+395,Doxylamine Succinate,doxylamine-succinate-395,https://medex.com.bd/attachments/mVvFG75udOlMfI0AKZCgYMs5sRzezU/doxylamine-succinate-prescribing-information,Sedating Anti-histamine,Watery eye,"Doxylamine is indicated for Hypersensitivity reactions, Insomnia
","Anti-emetic drugs, Sedating Anti-histamine
","Doxylamine is an antihistamine derived from monoethanolamine possessing antimuscarinic and pronounced sedative effects.
","Hypersensitivity reactionn: 25 mg every 4-6 hr. Max: 150 mg daily.
Insomnia: 25 mg given 30 minutes before retiring at night.
Should be taken with food. Take with food or milk.
",,"Enhance effects of CNS depressants eg alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives and antipsychotics. Atropine, TCAs, MAOIs. Can mask signs of ototoxicity caused by aminoglycosides.
","Severe liver disease; avoid alcohol; premature infants or full-term neonates.
","Acute dystonic reactions and long-lasting impaired consciousness in child. CNS depression including slight drowsiness to deep sleep, lassitude, dizziness, incoordination. Headache, psychomotor impairment and antimuscarinic effects. Rarely rashes and hypersensitivity reactions, blood disorders, convulsions, sweating, myalgia, extrapyramidal effects, tremor, confusion, tinnitus, hypotension, hair loss.
","Category A: Controlled studies in women fail to demonstrate a risk to the fetus in the 1st trimester (and there is no evidence of a risk in later trimesters), and the possibility of fetal harm remains remote.
","May impair ability to drive and operate machinery. Angle-closure galucoma, urinary retention, prostatic hypertrophy or pyloroduodenal obstruction; epilepsy; hepatic impairment. Elderly. Lactation.
",,,,,"Store at 15-30°C.
",10
+394,Doxycycline Hydrochloride,doxycycline-hydrochloride-394,https://medex.com.bd/attachments/vn5OVDC5O986xz3dRnxMeLIWz6QX8h/doxycycline-hydrochloride-prescribing-information,Tetracycline group of drugs,Uncomplicated gonorrhoea,"Doxycycline Hydrochloride is indicated in the following infections caused by susceptible microorganisms:
+
+- Respiratory tract infections: Pneumonia, influenza, sinusitis, bronchitis, tonsillitis, tracheitis.
+- Gastrointestinal tract infections: Cholera, traveler's diarrhea, shigella dysentery, acute intestinal amebiasis.
... Read more
Doxycycline Hydrochloride is indicated in the following infections caused by susceptible microorganisms:
+
+- Respiratory tract infections: Pneumonia, influenza, sinusitis, bronchitis, tonsillitis, tracheitis.
+- Gastrointestinal tract infections: Cholera, traveler's diarrhea, shigella dysentery, acute intestinal amebiasis.
+- Chlamydial infections: Lympho-granuloma venereum, psittacosis, trachoma.
+- Sexually transmitted diseases: Non gonococcal urethritis, acute pelvic inflammatory disease, uncomplicated urethral and endocervical or rectal infections, gonorrhoea, syphilis, pyelonephritis, cystitis.
+- Other infections: Impetigo, furunculosis, inclusion conjunctivitis, brucellosis, tularemia, cellulitis, acne and Q-fever.
+
","Tetracycline group of drugs
","Doxycycline Hydrochloride is a semisynthetic tetracycline antibiotic with broad spectrum activity. It is primarily a bacteriostatic antibiotic. It has a similar spectrum of activity to other tetracyclines but in particular is more active against Staphylococcus aureus and Nocardia. The drug is often active against penicillin-resistant strains of Staphylococcus aureus and against strains of those organisms that are resistant to other Tetracyclines. Certain Gram-negative strains of E. coli, Proteus mirabilis and Klebsiella, which are often resistant to Tetracycline, may be sensitive to Doxycycline. In addition, 70-90% of the various anaerobes are sensitive to Doxycycline and Bacteroides fragilis is more likely to be sensitive to Doxycycline than to other tetracyclines.
Doxycycline is active against most strains of Haemophilus influenzaeand is particularly useful for infections with H. ducreyi, Actinomyces, Brucella and Vibrio cholerae. It is also active against Nocardia, Chlamydia, Mycoplasma and a wide range of Rickettsiae. Doxycycline is active against spirochetes such as Borellia recurrentis, Treponema pallidum and Treponema pertenue. It is also active against Plasmodium falciparum.
","Usual dose: 200 mg on first day, then 100 mg daily for 7-10 days.
Severe infections (including refractory urinary tract infections): 200 mg daily for 10 days.
Acne: 100 mg daily.
Uncomplicated genital chlamydia, non-gonococcal urethritis: 100 mg twice daily for 7-21 days (14-21 days in pelvic inflammatory disease).
","Capsules should be swallowed whole with plenty of fluid during meals while sitting or standing.
","Absorption of tetracyclines is impaired by antacid containing aluminium, calcium or magnesium, and iron containing preparation. Absorption of tetracyclines is also impaired by bismuth salicylate. Barbiturates, carbamazepine and phenytoin decrease half-life of doxycycline. Concurrent use of tetracyclines may render oral contraceptive less effective. Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosages. It is advisable to avoid giving tetracyclines in conjunction with penicillin.
","Doxycycline is contraindicated to the patients who have shown hypersensitivity to any of the tetracyclines. Doxycycline is contraindicated to the children under 8 years of age. It is also contraindicated to pregnant women and to the lactating mothers.
","Nausea, vomiting, diarrhoea, skin rashes, hemolytic anaemia, eosinophilia may be reported.
","Doxycycline should be avoided in pregnant women, because of the risk of both staining and effect on bone growth in the foetus. Doxycyclines enter breast milk, and mothers taking these drugs should not breastfeed their child.
","The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of teeth. Tetracyclines drugs, therefore should not be used in this age group.
",,,,,"Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.
",11
+393,Doxorubicin Hydrochloride,doxorubicin-hydrochloride-393,https://medex.com.bd/attachments/9c65ijnuemsndZNN69fBa2thEiiEXa/doxorubicin-hydrochloride-prescribing-information,Cytotoxic Chemotherapy,Small cell lung cancer,"Doxorubicin is an anthracycline topoisomerase II inhibitor indicated for:
+
+- Ovarian cancer: After failure of platinum-based chemotherapy.
+- AIDS-related Kaposi’s Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy.
... Read more
Doxorubicin is an anthracycline topoisomerase II inhibitor indicated for:
+
+- Ovarian cancer: After failure of platinum-based chemotherapy.
+- AIDS-related Kaposi’s Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy.
+- Multiple Myeloma: In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy.
+
","Cytotoxic Chemotherapy
","Doxorubicin is a cytotoxic anthracycline antibiotic. The cytotoxic action results from its binding to DNA and inhibition of nucleic acid synthesis. Doxorubicin has been shown to produce regression in a variety of disseminated malignancies.
","Administer Doxorubicin at an initial rate of 1 mg/min to minimize the risk of infusion reactions. If no infusion related reactions occur, increase rate of infusion to complete administration over 1 hour. Do not administer as bolus injection or undiluted solution.
+
+- Ovarian cancer: 50 mg/m2 IV every 4 weeks
+- AIDS-related Kaposi’s Sarcoma: 20 mg/m2 IV every 3 weeks
+- Multiple Myeloma: 30 mg/m2 IV on day 4 following bortezomib
+
",,"Doxorubicin interacts with a number of other drugs e.g. antibiotics (aminoglycosides), steroids, aminophylline and propranolol.
","Cardiac disease, neonates, pregnancy and lactation, prior irradiation to mediastinum. IM/SC admin. Severe myelosuppression due to previous treatment with antitumour agents or radiotherapy.
","Leucopenia, thrombocytopenia, nausea, vomiting, diarrhoea. Rarely facial flushing, rash, alopecia. Blurred vision, headache, seizures, paraesthesia, confusion, malaise, lethargy, skin pigmentation.
","Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Elderly, children, hepatic impairment. Monitor blood counts and ECG.
","Hepatic Impairment-
serum-bilirubin: 12-30 mcg/ml: Half the normal dose;
serum-bilirubin: >30 mcg/ml: Quarter of the usual dose.
","Acute overdosage may increase the toxic effects of mucositis, leukopenia and thrombocytopenia. Treatment includes hospitalisation of the severely myelosuppressed patient, antimicrobials, platelet transfusions and symptomatic treatment of mucositis. Use of haemopoietic growth factor (G-CSF, GM-CSF) may be considered. Cumulative dosage increases risk of cardiomyopathy and resultant congestive heart failure which may be managed with digitalis preparations, diuretics, and after load reducers such as ACE inhibitors.
",,,"Powder for injection: Store at 15-30°C.
Solution for injection & liposomal formulations: Refrigerate at 2-8°C. Do not freeze.
",12
+392,Doxophylline,doxophylline-392,https://medex.com.bd/attachments/S8JdUwRFD6gWa5fRXmq7cE3gcLzhvH/doxophylline-prescribing-information,Bronchodilator,Severe bronchospasm,"Doxophylline is used to treat in following indications:
+
+- Bronchial asthma
+- Bronchospasm
+- Chronic obstructive pulmonary disease (COPD)
+- Pulmonary disease with spastic bronchial component.
+
","Bronchodilator, Methyl xanthine derivatives
","Doxophylline is a novel bronchodilator. It structurally differs from Theophylline due to the presence of a dioxolane group in position 7. Doxophylline selectively inhibits phosphodiesterase 4 thereby relaxes bronchial smooth muscle. However, differently from Theophylline, Doxophylline appears to have decreased affinities toward adenosine A1 and A2 receptors, which may account for the better safety profile of the drug. Doxophylline is reported to inhibit platelet activating factor (PAF) and generation of leukotriene production.
","Elderly: 200 mg tablet two or three times daily.
Adults: 400 mg tablet two or three times daily or as prescribed by the physician.
Children:
+
+- >12 years of age: 10 ml syrup or 200 mg tablet two or three times daily.
+- 6-12 years of age: 6-9 mg/kg body weight two times daily, i.e. if body weight is 10 kg, 3 ml (60 mg) two times daily or as prescribed by the physician.
+
+If required daily dose of Doxophylline is 400 mg then Doxophylline SR tablet to be taken once daily or as prescribed by the physician
",,"Doxophylline should not be administered together with other xanthine derivatives. Toxic synergism with ephedrine has been documented for xanthines. Like other xanthines, concomitant therapy with troleandomycin, lincomycin, clindamycin, allopurinol, cimetidine, ranitidine, propranolol and anti-flu vaccine may decrease the hepatic clearance of xanthines causing an increase in blood levels. No evidence of a relationship between Doxophylline serum concentrations and toxic events have been reported.
","Doxophylline is contraindicated in acute myocardial infarction. It is also contraindicated in patients with hypotension, in lactating women & patients who have shown hypersensitivity to its components.
","Doxophylline rarely causes serious side effects, however possible side effects are similar for taking excess amount of caffeine. These include: nausea, vomiting, headache, upset stomach and heartburn.
","Animal reproduction studies indicate that, Doxophylline does not cause fetal harm when administered to pregnant animals or can not affect reproduction capacity. However, since there is limited experience in human during pregnancy, xanthines should be given to pregnant women only if clearly needed. Doxophylline is contraindicated in nursing mothers.
","The half-life of xanthine derivatives is influenced by a number of known variables. It may be prolonged in patients with liver disease, in patients with congestive heart failure and in those patients taking certain other drugs like erythromycin, troleandomycin, lincomycin, allopurinol, cimetidine, propanolol and anti-flu vaccine. In these cases, a lower dose of Doxophylline may be needed. Phenytoin, other anticonvulsants and smoking may cause an increase in clearance with a shorter mean half-life. In these cases higher doses of Doxophylline may be needed.
",,"In case of overdose severe cardiac arrhythmias and tonic-clonic seizure may occur. These effects may represent the first signs of intoxication. The appearance of side effects may require discontinuation of the treatment which, if necessary, at the physician’s discretion, may be resumed at lower doses after all signs and symptoms of toxicity have subsided.
As there is no specific antidote, in case of overdose a symptomatic treatment of cardiovascular collapse should be instituted.
",,,"Keep in a dry place away from light and heat. Keep out of the reach of children. Doxophylline should be used only on prescription of specialist physician.
",11
+391,Doxepin (Topical),doxepin-topical-391,https://medex.com.bd/attachments/72edRBuLglP4uiMQBsmQ3GUBiTUfbQ/doxepin-topical-prescribing-information,Local Antipruritic,Pruritus,"Doxepin cream is indicated for the short-term (upto 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus.
","Local Antipruritic
","Doxepin hydrochloride is one of a class of agents known as dibenzoxepin tricyclic antidepressant compounds. Although doxepin HCl does have H1 and H2 histamine receptor blocking actions, the exact mechanism by which doxepin exerts its antipruritic effect is unknown. It can produce drowsiness in significant numbers of patients, and this sedation may reduce awareness, including awareness of pruritic symptoms.
","Adult and child over 12 years: apply thinly 3-4 times daily; usual max. 3 g per application; usual total max. 12 g daily; coverage should be less than 10% of body surface area.
Use in Children: The use of Doxiderm cream in pediatric patients is not recommended. Safe conditions for use of cream in children have not been established.
Use in Elderly Patients: Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
",,"Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 like MAO inhibitors, cimetidine, alcohol may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. MAO inhibitors should be discontinued at least two weeks prior to the cautious initiation of therapy with Doxepin cream.
","Patients with untreated narrow-angle glaucoma or a tendency to urinary retention because doxepin has an anticholinergic effect. Individuals who have shown previous sensitivity to any of its components
","Drowsiness, local burning, stinging, irritation, tingling, rash; systemic side-effects such as antimuscarinic effects, headache, fever, dizziness, gastro-intestinal disturbances has been reported.
","Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Doxepin is excreted in human milk after oral administration. It is possible that doxepin may also be excreted in human milk following topical application of Doxepin cream.
","Cautions should be exercised if there is susceptibility to angle-closure glaucoma, urinary retention, severe liver impairment, mania and also in pregnancy and breast-feeding. Drowsiness may affect performance of skilled tasks (e.g. driving) so patient should be careful.
",,"If overdosage with topical application of Doxepin cream occur, the signs and symptoms may include cardiac dysrhythmias, severe hypotension, convulsions, and CNS depression, including coma. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of tricyclic antidepressant toxicity. Other signs of overdose may include confusion, disturbed concentration, transient visual hallucinations, dilated pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, hyperpyrexia.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+390,Doxepin (Oral),doxepin-oral-390,https://medex.com.bd/attachments/Ax3NPEzXClJPyzIi8wmgHycjG9E2u7/doxepin-oral-prescribing-information,Tricyclic & related anti-depressant drugs,Insomnia and sleep disturbances,"Doxepin is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.
","Tricyclic & related anti-depressant drugs
","Doxepin binds with high affinity to the histamine H1 receptor (Ki<1 nM) where it functions as an antagonist. The exact mechanism by which doxepin exerts its sleep maintenance effect is unknown but is believed due to its antagonism of the H1 receptor.
","Dosing in Adults: The recommended dose of Doxepin for adults is 6 mg once daily. A 3 mg once daily dose may be appropriate for some patients, if clinically indicated.
Dosing in the Elderly: The recommended starting dose of Doxepin in elderly patients (≥65 years old) is 3 mg once daily. The daily dose can be increased to 6 mg, if clinically indicated.
Administration: Doxepin should be taken within 30 minutes of bedtime. To minimize the potential for next day effects, Doxepin should not be taken within 3 hours of a meal. The total Doxepin dose should not exceed 6 mg per day.
Pediatric Use: The safety and effectiveness of Doxepin in pediatric patients have not been evaluated.
",,"Cytochrome P450 Isozymes: Doxepin is primarily metabolized by hepatic cytochrome P450 isozymes CYP2C19 and CYP2D6, and to a lesser extent, by CYP1A2 and CYP2C9. Inhibitors of these isozymes may increase the exposure of doxepin. Doxepin is not an inhibitor of any CYP isozymes at therapeutically relevant concentrations. The ability of Doxepin to induce CYP isozymes is not known.
Cimetidine: Doxepin exposure is doubled with concomitant administration of cimetidine, a nonspecific inhibitor of CYP isozymes. A maximum dose of 3 mg is recommended in adults and elderly when cimetidine is co administered with Doxepin.
Alcohol: When taken with Doxepin, the sedative effects of alcohol may be potentiated.
CNS Depressants and Sedating Antihistamines: When taken with Doxepin, the sedative effects of sedating antihistamines and CNS depressants may be potentiated.
Tolazamide: A case of severe hypoglycemia has been reported in a type II diabetic patient maintained on tolazamide (1 g/day) 11 days after the addition of oral doxepin (75 mg/day).
","Hypersensitivity: Doxepin is contraindicated in individuals who have shown hypersensitivity to doxepin HCl,
any of its inactive ingredients, or other dibenoxepines.
Co-administration with Monoamine Oxidase Inhibitors (MAOIs): Serious side effects and even death have been reported following the concomitant use of certain drugs with MAO inhibitors. Do not administer Doxepin if patient is currently on MAOIs or has used MAOIs within the past two weeks. The exact length of time may vary depending on the particular MAOI dosage and duration of treatment.
Glaucoma and Urinary Retention: Doxepin is contraindicated in individuals with untreated narrow-angle glaucoma or severe urinary retention.
","The following serious adverse reactions are as follows:
+
+- Abnormal thinking and behavioral changes
+- Suicide risk and worsening of depression
+- CNS Depressant effects
+
","Pregnancy Category C. There are no adequate and well-controlled studies of Doxepin in pregnant women. Doxepin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Administration of doxepin to pregnant animals resulted in adverse effects on offspring development at doses greater than the maximum recommended human dose (MRHD) of 6 mg/day.
Doxepin is excreted in human milk after oral administration. There has been a report of apnea and drowsiness occurring in a nursing infant whose mother was taking the higher dose of doxepin used to treat depression. Caution should be exercised when Doxepin is administered to nursing women.
","Need to Evaluate for Comorbid Diagnoses: Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Exacerbation of insomnia or the emergence of new cognitive or behavioral abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with hypnotic drugs.
Abnormal Thinking and Behavioral Changes: Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a hypnotic, with amnesia for the event) have been reported with hypnotics. These events can occur in hypnotic-naive as well as in hypnotic-experienced persons. Although behaviors such as ""sleep-driving"" may occur with hypnotics alone at therapeutic doses, the use of alcohol and other CNS depressants with hypnotics appears to increase the risk of such behaviors, as does the use of hypnotics at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of Doxepin should be strongly considered for patients who report a ""sleep-driving"" episode. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a hypnotic. As with ""sleep-driving"", patients usually do not remember these events. Amnesia, anxiety and other neuro-psychiatric symptoms may occur unpredictably.
Suicide Risk and Worsening of Depression: In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including completed suicides), has been reported in association with the use of hypnotics. Doxepin, the active ingredient in Doxepin, is an antidepressant at doses 10- to 100-fold higher than in Doxepin. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Risk from the lower dose of doxepin in Doxepin can not be excluded. It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+389,Dorzolamide + Timolol,dorzolamide-timolol-389,https://medex.com.bd/attachments/IFOvf5U0l8IjsBXyZxVBo5ILia4ZNm/dorzolamide-timolol-prescribing-information,Drugs for miotics and glaucoma,Open angle glaucoma,"This Eye Drops is indicated for the treatment of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta blockers.
","Drugs for miotics and glaucoma
","Dorzolamide, a carbonic anhydrase inhibitor, has actions similar to acetazolamide. By inhibiting carbonic anhydrase in the ciliary processes of the eye, dorzolamide decreases aqueous humor secretion. Used together, there is additional intraocular pressure reduction compared to using either component alone, but the reduction is not as much as concomitant admin of dorzolamide tid and timolol bid.
Timolol maleate, a nonselective β-adrenergic blocker, reduces aqueous humor formation.
","Instill one drop in the conjunctival sac of the affected eye(s) twice daily.
",,"Additive hypotension and bradycardia with oral calcium channel blockers, catecholamine-depleting drugs or β-blockers, antiarrhythmics (e.g. amiodarone), digitalis glycosides, parasympathomimetics, narcotics and MAOIs. Additive systemic side effects with oral carbonic anhydrase or β-blockers; avoid concurrent use. Additive systemic β-blockade with CYP2D6 inhibitors (e.g. quinidine, SSRIs) and timolol.
","Contraindicated in patients who are hypersensitive to any of the components of this preparation.
","Mild burning, ocular hyperemia, blurred vision may occur.
","Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. This Eye Drops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: Caution should be exercised when This Eye Drops is administered to a nursing mother.
","For ophthalmic use only. Patients should remove their contact lenses prior to instilling this preparation and should not insert their lenses until 15 minutes after instillation of the preparation.
","Use in children: Safety and effectiveness in children below the age of 2 years have not been established.
Use in elderly patients: No overall differences in safety and effectiveness have been observed between elderly and other adult patients.
",,,,"Store between 15-30°C. Protect from light.
",11
+388,Doripenem,doripenem-388,https://medex.com.bd/attachments/riQh9zZ8QpdwWP6dzphE1MobX3TWlW/doripenem-prescribing-information,Other beta-lactam Antibiotics,Urinary tract infection,"To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doripenem and other antibacterial drugs, Doripenem should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are ... Read more
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doripenem and other antibacterial drugs, Doripenem should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting and modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Complicated Intra-Abdominal Infections: Doripenem injection is indicated as a single agent for the treatment of complicated intra-abdominal infections caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides caccae, Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Streptococcus intermedius, Streptococcus constellatus and Peptostreptococcus micros.
Complicated Urinary Tract Infections, Including Pyelonephritis: Doripenem injection is indicated as a single agent for the treatment of complicated urinary tract infections, including pyelonephritis caused by Escherichia coli including cases with concurrent bacteremia, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa and Acinetobacter baumannii.
","Other beta-lactam Antibiotics
","Doripenem is a synthetic broad-spectrum carbapenem β-lactam antibiotic with potent in vitro antibacterial activity against aerobic and anaerobic gm+ve and gm-ve bacteria including Pseudomonas aeruginosa. It inhibits bacterial cell wall synthesis by binding to several penicillin-binding proteins, which in turn inhibits the final transpeptidase step of peptidoglycan synthesis in bacterial cell walls.
","Intravenous-
+
+- Complicated intra-abdominal infections: 500 mg 8 hrly infused over 1 hr for 5-14 days. May switch to an appropriate oral therapy, after at least 3 days of parenteral therapy.
+- Complicated UTI, Pyelonephritis: 500 mg 8 hrly infused over 1 hr for 10 days. May switch to an appropriate oral therapy, after at least 3 days of parenteral therapy.
+- Patient with concurrent bacteraemia: Duration can be extended up to 14 days.
+
+
Renal impairment-
+
+- CrCI (30-50 ml/min): 250 mg every 8 hr by IV infusion over 1 hr
+- CrCI (11 -29 ml/min): 250 mg every 12 hr by IV infusion over 1 hr
+
",,"Increased plasma concentration with probenecid. May decrease plasma levels of valproic acid thus, increasing the risk of seizures.
","Hypersensitivity to doripenem, other carbapenem antibacterial agents; history of anaphylactic reaction to β-lactams (e.g. penicillins, cephalosporins).
","Headache, nausea, diarrhoea, rash, pruritus, phlebitis, elevated hepatic enzymes, oral candidiasis, anaemia, vulvomycotic infection, thrombocytopenia, neutropenia.
","Pregnancy Category B. Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
","Patient with known or suspected CNS disorders (e.g. brain lesions, history of seizures). Not intended for treatment of any type of pneumonia. Renal impairment. Pregnancy and lactation. Monitoring Parameters Monitor renal function and for signs of anaphylaxis during 1st dose. Consider haematologic assessment during prolonged therapy.
",,,,,"Reconstituted suspension may be held for 1 hr prior to dilution in infusion bag. Following dilution of the suspension with NaCl 0.9%, stability is 8 hr at room temperature or 24 hr between 2-8°C. Stability of solution when diluted with dextrose 5% injection is 4 hr at room temperature or 24 hr between 2-8°C.
",10
+387,Dopamine Hydrochloride,dopamine-hydrochloride-387,https://medex.com.bd/attachments/pRyX3vId7FswnidFjVRNLaPI07INnc/dopamine-hydrochloride-prescribing-information,Inotropic-sympathomimetics,Hypotension,"Dopamine is recommended for the correction of haemodynamic imbalance present in-
+
+- Acute hypotension or shock associated with myocardial infarction, endotoxic septicaemia, trauma and renal failure.
+- As an adjunct after open heart surgery, where there is persistent hypotension after correction of hypovolaemia.
+- In chronic cardiac decompensation as in congestive failure.
+
","Inotropic-sympathomimetics
","Dopamine is a preparation of Dopamine hydrochloride which can stimulate α, β and dopamine receptors. It is a natural catecholamine formed by the decarboxylation of 3,4-dihydroxyphenylalanine (DOPA). Dopamine is a precursor to norepinephrine in noradrenergic nerves and is also a neurotransmitter in certain areas of the central nervous system, especially in the nigrostriatal tract and in a few peripheral sympathetic nerves. It produces positive chronotropic and inotropic effects on the myocardium, resulting in increased heart rate and cardiac contractility. This is accomplished directly by exerting an agonist action on β-adrenoceptors and indirectly by causing release of norepinephrine from storage sites in sympathetic nerve endings. Dopamine does not cross the blood-brain barrier and so does not activate dopamine receptors in the brain.
","Adult dose: Where appropriate, the circulating blood volume must be restored with a suitable plasma expander or whole blood, prior to administration of dopamine. Begin infusion of dopamine hydrochloride solution at dosage of 2 to 5 micrograms/kg/min in patients who are likely to respond to a modest increment of heart force and renal perfusion.
In more seriously ill patients, begin infusion of dopamine hydrochloride solution at dosage of 5 micrograms/kg/min and increase gradually using 5 to 10 micrograms/kg/min increment up to 20 to 50 micrograms/kg/min as needed. If dosage in excess of 50 micrograms/kg/min are required, it is suggested that urine output should be checked frequently. In patients who do not respond to this doses, additional increments of dopamine may be given in an effort to achieve adequent blood pressure, urine flow and perfusion.
For patients with severe, refractory, chronic congestive heart failure doses should be started on 0.5 to 2 micrograms/kg/min, and the dose increased by 1 to 3 micrograms/kg/min as urinary output increases.
ECG, blood pressure and urine output should be monitored. Cardiac output and pulmonary wedge pressure should be monitored if possible.
Children less than 12 years old: The safety and efficacy of dopamine in children under 12 years has not been established.
Geriatric patients: No variation in dosage is suggested for geriatric patients. However, close monitoring is required for blood pressure, urine flow, and peripheral tissue perfusion.
","Rate of administration: After dilution dopamine hydrochloride is administered intravenously through a suitable intravenous catheter or needle. An intravenous drip chamber or other suitable metering device is essential for controlling the rate of flow in drops per minute. Each patient must be individually titrated to the desired haemodynamic and/or renal response with dopamine hydrochloride. In titrating to the desired increase in systolic blood pressure, the optimum dosage rate for renal response may be exceeded, thus necessitating a reduction in rate after the haemodynamic condition is stabilized. Administration rate greater than 50 micrograms/kg/minute have safely been used in advanced circulatory decompensation states. If unnecessary fluid expansion is of concern, adjustment of drug concentration may be preferred over increasing the flow rate of a less concentrated dilution.
","The action of dopamine hydrochloride is potentiated by monoamine oxidase inhibitors (MAOI's). The concurrent administration of cyclopropane or halogenated hydrocarbon anesthetics may cause ventricular arrhythmias. The cardiac effects of dopamine hydrochloride are antagonized by β - adrenergic blocking agents such as Propranolol and Metoprolol. The ergot alkaloids should be avoided because of the possibility of excessive vasoconstriction. Tricyclic antidepressants and guanethidine may potentiate the pressor response to dopamine hydrochloride. Hypotension and bradycardia have been observed in patients receiving Phenytoin. Dopamine hydrochloride may increase the effect of diuretic agents. Peripheral vasoconstriction may be antagonized by α - adrenergic blocking agents, such as Phentolamine. Other vasodilators may also be useful in patients with heart failure, allowing greater inotropic and renal effects without the associated vasoconstriction. Care must be taken to avoid hypotension.
","Dopamine hydrochloride is contraindicated in patients with known hypersensitivity to dopamine or any of its ingredients. It should not be used in patients with phaeochromocytoma, uncorrected tachyarrhythmias, or ventricular fibrillation. Dextrose solution without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility of pseudoagglutination of red cells.
","The most frequent reported adverse reactions are ectopic beats, nausea, vomiting, tachycardia, anginal pain, palpitations, dyspnoea, headache, hypotension, hypertension and vasoconstriction. Other less frequent adverse reactions are aberrant ventricular conduction, bradycardia, piloerection, mydriasis, widened QRS complex, azotaemia and elevated blood pressure. Peripheral ischemic gangrene in patients with pre-existing vascular disease. Fatal ventricular arrhythmias have been reported on rare occasions.
","Animal studies have revealed no evidence of teratogenic effects from dopamine hydrochloride. The drug may be used in pregnant women when in the judgment of the physician the expected benefits outweigh the potential for risk to the fetus. It is not known if dopamine hydrochloride is excreted in breast milk, nor is the effect on the infant known. It is not recommended for breast-feeding mothers unless the expected benefits outweigh any potential risks
","Dopamine hydrochloride should not be administered in the presence of uncorrected tachyarrhythmia or ventricular fibrillation. It is metabolized in the tissues and blood by monoamine oxidase (MAO) and catechol-O-methyltransferase (COMT). Dopamine hydrochloride and its metabolites are almost completely excreted in the urine. Patients who have been treated with monoamine oxidase inhibitors (MAOI) prior to the administration of dopamine will require substantially reduced dosages of later. The starting dose in such patients should be reduced to at least one-tenth (1/10) of the usual dose. Excess administration of potassium-free solutions may result in significant hypokalemia. The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentration, overhydration, congested states or pulmonary oedema. Closely monitoring is advised in patients with impaired renal and hepatic function.
Hypovolaemia should be corrected where necessary prior to treatment with dopamine hydrochloride. If a disproportionate rise in diastolic blood pressure (i.e. a marked decrease in pulse pressure) is observed, the infusion rate should be decreased and the patients observed carefully for further evidence of predominant vasoconstriction activity, unless such effect is desired. Dopamine hydrochloride infusion should be withdrawn gradually, to avoid unnecessary hypotension. Patients with a history of peripheral vascular disease (e.g. atherosclerosis, arterial embolism, Raynaud's disease, cold injury, diabetic endarteritis and Buerger's disease) should be closely monitored for any changes in color or temperature of the skin in the extremities. If ischemia occurs and is thought to be the result of vasoconstriction, the benefits of continued dopamine hydrochloride infusion should be weighed against the risk of possible necrosis. These changes may be reversed by either decreasing the rate or discontinuing the infusion. Dopamine hydrochloride in 5% dextrose solution should be infused into a large vein whenever possible to prevent the possibility of infiltration of perivascular tissue adjacent to the infusion site. Extravasations may cause necrosis and sloughing of the surrounding tissue. Ischaemia can be reversed by infiltration of the affected area with 10-15ml of saline containing 5 to 10mg Phentolamine mesylate. Dopamine hydrochloride should be used with extreme caution in patients inhaling cyclopropane or halogenated hydrocarbon anaesthetics due to the arterial arrhythmogenic potential. Dextrose solutions should be used with caution in patients with known subclinical or over diabetes mellitus.
",,"In case of accidental overdosage, as evidenced by excessive blood pressure elevation, reduce the rate of administration or temporarily discontinue dopamine hydrochloride until the patients condition stabilized. Since the duration of action of dopamine hydrochloride is quite short, no additional measures are usually necessary. If these measures fail to stabilize the patient's condition, use of the short-acting α-adrenergic blocking agent such as Phentolamine should be considered.
",,"Dopamine hydrochloride must be diluted before administration to patients. Transfer contents of one or more ampoules by aseptic technique to either 250 ml or 500 ml of one of the following sterile intravenous solutions: 0.9% Sodium Chloride, 5% Dextrose, 5% Dextrose and 0.9% Sodium Chloride, 5% Dextrose in 0.45% Sodium Chloride, 5% Dextrose in Ringer's Lactate, Sodium Lactate (1/6 Molar), Ringer's Lactate. Dopamine hydrochloride has been found to be stable for a minimum of 24 hours after dilution in the sterile intravenous solutions listed above. However, as with all intravenous admixtures, dilution should be made just prior to administration. Do not add dopamine hydrochloride solution to sodium bicarbonate or other alkaline intravenous solutions, since the drug is inactivated in alkaline solution. Mixing of dopamine hydrochloride with alteplase in the same container should be avoided as visible particulate matter has been observed. It is recommended that dopamine should not be added to amphotericin B solution because amphotericin B is physically unstable in dopamine-containing solutions.
","Store below 25°C and protect from light.
",13
+424,Eptifibatide,eptifibatide-424,https://medex.com.bd/attachments/Z63hSEj5mZWI5Q80Cr0OzA62tj0Pls/eptifibatide-prescribing-information,Anti-platelet drugs,Unstable angina,"Eptifibatide is indicated in-
+
+- Patients with acute coronary syndrome (unstable angina/non-ST- segment elevation myocardial infarction), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI).
+- Patients undergoing PCI, including those undergoing intracoronary stenting.
+
","Anti-platelet drugs
","Eptifibatide is a cyclic heptapeptide containing six amino acids and one mercaptopropionyl (des-amino cysteinyl) residue. Integril binds to the platelet receptor glycoprotein (GP) IIb/IIIa of human platelets and reversibly inhibits platelet aggregation by preventing the binding of fibrinogen, von Willebrand factor, and other adhesive ligands to GP IIb/IIIa.
","Patients with ACS (Acute Coronary Syndrome):
+
Normal renal function: 180 μg/kg IV bolus of as soon as possible following diagnosis followed by a continuous infusion of 2 μg/kg/min.
Creatinine clearance: 180 μg/kg IV bolus of as soon as possible following diagnosis followed by a continuous infusion of 1 μg/kg/min
.
+
+- Infusion should continue until hospital discharge or initiation of coronary artery bypass graft surgery (CABG), up to 72 hours.
+- If a patient is to undergo PCI, the infusion should be continued until hospital discharge or for up to 18 to 24 hours after the procedure, whichever comes first, allowing for up to 96 hours of therapy.
+
+
Patients with PCI ( Percutaneous Coronary Intervention):
+
Normal renal function: 180 μg/kg IV bolus immediately before PCI followed by a continuous infusion of 2 μg/kg/min & a second bolus of 180 μg/kg (given 10 minutes after the first bolus)
Creatinine clearance: 180 μg/kg IV bolus immediately before PCI followed by a continuous infusion of 1 μg/kg/min & a second bolus of 180 μg/kg (given 10 minutes after the first bolus)
+
+- Infusion should be continued until hospital discharge, or for up to 18 to 24 hours, whichever comes first. A minimum of 12 hours of infusion is recommended.
+- In patients who undergo CABG surgery, INTEGRILIN infusion should be discontinued prior to surgery.
+
","1. Integril solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
2. Integril may be administered in the same IV line as alteplase, atropine, dobutamine, heparin, lidocaine, meperidine, metoprolol, midazolam, morphine, nitroglycerin, or verapamil. Integril should not be administered through the same IV line as furosemide.
3. Integril may be administered in the same IV line with 0.9% NaCl or 0.9% NaCl/5% dextrose. With either vehicle, the infusion may also contain up to 60 mEq/L of KCl.
4. The bolus dose(s) of Integril should be withdrawn from the 10-mL vial into a syringe. The bolus dose(s) should be administered by IV push.
5. Immediately following the bolus dose administration, a continuous infusion of Integril should be initiated. When using an intravenous infusion pump, Integril should be administered undiluted directly from the 100 mL vial. The 100-mL vial should be spiked with a vented infusion set. Care should be taken to center the spike within the circle on the stopper top.
","• In various clinical studies, eptifibatide was used concomitantly with unfractionated heparin and aspirin. In another study, clopidogrel or ticlopidine were used routinely starting the day of PCI. Because eptifibatide inhibits platelet aggregation, caution should be employed when it is used with other drugs that affect hemostasis, including thrombolytics, oral anticoagulants, NSAIDS and dipyridamole. To avoid potentially additive pharmacologic effects, concomitant treatment with other inhibitors of platelet receptor GP IIb/IIIa should be avoided
• Enoxaparin did not alter the pharmacokinetics of Integril
","contraindicated in patients with:
+
+- A history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days.
+- Severe hypertension (systolic blood pressure > 200 mm Hg or diastolic blood pressure > 110 mm Hg) not adequately controlled on antihypertensive therapy.
+
","Bleeding is the most common adverse effect. Adverse reactions include intracranial hemorrhage & stroke, thrombocytopenia, allergic reactions and hypotension.
","Pregnancy: Category B. Animal studies revealed no evidence of harm to the fetus due to Integril. There are, however, no adequate and well-controlled studies in pregnant women with Integril.
Lactating Mothers: It is not known whether Integril is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Integril is administered to a nursing mother.
",,"Use in Children: Safety and effectiveness of Integril in pediatric patients have not been studied.
","• There has been only limited experience with overdosage of Integril. Symptoms of acute toxicity were loss of righting reflex, dyspnea, ptosis, and decreased muscle tone in rabbits, and petechial hemorrhages in the femoral and abdominal areas of monkeys.
• From in vitro studies, eptifibatide is not extensively bound to plasma proteins and thus may be cleared from plasma by dialysis.
",,,"• Vials should be stored refrigerated at 2-8° C
• Vials may be transferred to room temperature storage for up to 2 months.
• Unused portion left in the vial should be discarded.
• Vials should be protected from light until administration.
",12
+423,Epoetin Beta,epoetin-beta-423,https://medex.com.bd/attachments/NWYC4WIUCtIY7RQnWrddOvhiGQxAdW/epoetin-beta-prescribing-information,Drugs for Haemolytic Hypoplastic & Renal Anemia,To reduce the need for allogenic blood tranfusion,"Epoetin Beta is indicated for:
+
+- Treatment of symptomatic anemia associated with chronic kidney disease (CKD) in patients on dialysis.
+- Treatment of symptomatic renal anemia in patients not yet undergoing dialysis.
+- Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 g and a gestational age of less than 34 weeks.
... Read more
Epoetin Beta is indicated for:
+
+- Treatment of symptomatic anemia associated with chronic kidney disease (CKD) in patients on dialysis.
+- Treatment of symptomatic renal anemia in patients not yet undergoing dialysis.
+- Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 g and a gestational age of less than 34 weeks.
+- Treatment of symptomatic anemia in adult patients with non-myeloid malignancies receiving chemotherapy.
+- Increasing the yield of autologous blood from patients in a pre-donation programme.
+
+Its use in this indication must be balanced against the reported increased risk of thromboembolic events. Treatment should only be given to patients with moderate anemia (Hb 10–13 g/dl [6.21–8.07 mmol/l], no iron deficiency) if blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
","Drugs for Haemolytic Hypoplastic & Renal Anemia
","Epoetin beta is identical in its amino acid and carbohydrate composition to erythropoietin that has been isolated from the urine of anemic patients. Erythropoietin is a glycoprotein that stimulates the formation of erythrocytes from its committed progenitors. It acts as a mitosis-stimulating factor and differentiation hormone. Erythropoietin is a glycoprotein that, as a growth factor, primarily stimulates the formation of erythrocytes from its committed progenitors. It acts as a mitosis-stimulating factor and differentiation hormone.
","Therapy with Recormon should be initiated by physicians experienced in the above- mentioned indications. As anaphylactoid reactions were observed in isolated cases, it is recommended that the first dose be administered under medical supervision. Substitution by any other biological medicinal product requires the consent of the prescribing physician.
Lyophilisate and solvent for solution for injection: The multidose preparation can be used for several patients. To avoid the risk of cross-infection, always follow aseptic techniques and use disposable sterile syringes and needles for each administration.
Solution for injection in pre-filled syringe: The Recormon pre-filled syringe is ready for use. Under no circumstances should more than one dose be administered per syringe; the medicinal product is for single use only.
Treatment of patients with anemia due to chronic kidney disease: The reconstituted solution can be administered subcutaneously or intravenously. In case of intravenous administration, the solution should be injected over approx. 2 minutes, e.g. in hemodialysis patients via the arterio-venous fistula at the end of dialysis. For non-hemodialysed patients, subcutaneous administration should always be preferred in order to avoid puncture of peripheral veins. In CKD patients, the aim of treatment is to reach a target Hb level of 10–12 g/dl. An Hb level of 12 g/dl should not be exceeded. If the rise in hemoglobin is greater than 2 g/dl (1.3 mmol/l) in 4 weeks, an appropriate dose reduction should be considered. In the presence of hypertension or existing cardiovascular, cerebrovascular or peripheral vascular diseases, the weekly increase in Hb and the target Hb should be determined individually taking into account the clinical picture. Patients should be monitored closely to ensure that the lowest dose of Recormon is used to provide adequate control of the symptoms of anemia.
",,"No dedicated clinical interaction studies have been performed. Clinical experience has not given evidence for potential interaction of Recormon with other medicinal products. In animal experiments epoetin did not increase the myelotoxicity of cytostatic medicinal products like etoposide, cisplatin, cyclophosphamide, and fluorouracil.
","Epoetin Beta is contraindicated in patients with:
+
+- Known hypersensitivity to the active substance or any of the excipients.
+- Poorly controlled hypertension.
+
+In the indication ""increasing the yield of autologous blood"", Recormon must not be used
in patients who, in the month preceding treatment, have suffered a myocardial infarction
or stroke, patients with unstable angina pectoris, or patients who are at increased risk of
deep venous thrombosis such as those with a history of venous thromboembolic disease.
","Rarely (≥1/10,000 to ≤1/1,000), skin reactions such as rash, pruritus, urticaria or injection site reactions may occur. In very rare cases (≤1/10,000) anaphylactoid reactions have been reported. However, in controlled clinical studies no increased incidence of hypersensitivity reactions was found. In very rare cases (≤1/10,000), particularly when starting treatment, flu-like symptoms such as fever, chills, headaches, pain in the limbs, malaise and/or bone pain have been reported. These reactions were mild or moderate in nature and subsided after a couple of hours or days.
","Pregnancy: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. For epoetin beta, all safety information with regard to exposure to Recormon during pregnancies has been gained from post-marketing experience. A review of the available post-marketing data does not show evidence of a causal association between harmful effects with respect to pregnancy, embryonal/fetal development or postnatal development and treatment with Recormon. However in the absence of clinical study data, caution should be exercised when prescribing to pregnant women.
Lactation: Only limited experience in human lactation has been gained. Endogeneous erythropoietin is excreted in breast milk and readily absorbed by the neonatal gastrointestinal tract. A decision on whether to continue or discontinue breastfeeding or to continue or discontinue therapy with epoetin beta should be made taking into account the benefit of breastfeeding to the child and the benefit of epoetin beta therapy to the woman.
",,"Pediatric use: Results of pediatric clinical studies have shown that, on average, the younger the patients, the higher the Recormon doses required. Nevertheless, the recommended dosing schedule should be followed as the individual response cannot be predicted.
Geriatric use: No dedicated studies in geriatric patients were performed. A large proportion of geriatric patients were included in clinical trials with Recormon. A need for special dose adjustments in the geriatric population was not identified.
Hepatic Impairment: No dedicated clinical trials were conducted in patients with hepatic impairment. No special dosage Instructions are available.
","The therapeutic range of Recormon is wide and individual response to therapy must be considered when Recormon treatment is initiated. Overdose can result in manifestations of an exaggerated pharmacodynamic effect, e.g. excessive erythropoiesis which may be associated with life-threatening complications of the cardiovascular system. In case of excessive hemoglobin levels, Recormon should be temporarily withheld. If clinically indicated, phlebotomy may be performed.
",,,"Store in a refrigerator 2°C–8°C. Keep the vial/cartridge/pre-filled syringe in the outer carton, in order to protect from light
",11
+421,Eplerenone,eplerenone-421,https://medex.com.bd/attachments/nQ6rbzqtZqZuRtNxixQmQ7a7R18XtT/eplerenone-prescribing-information,Potassium-sparing diuretics,Oedema,"Congestive heart failure after an acute myocardial infarction, Hypertension.
","Potassium-sparing diuretics, Potassium-sparing diuretics & Aldosterone antagonists
","Eplerenone selectively binds to the mineralocorticoid receptor and blocks the binding of aldosterone, a key component in the renin-angiotensin-aldosterone-system, which is involved in the regulation of BP and pathophysiology of CV disease. Aldosterone binds to mineralocorticoid receptors in both epithelial (e.g. kidney, GI tract) and nonepithelial (e.g. heart, blood vessels, brain) tissues; causing increases in BP by inducing Na reabsorption, vascular remodelling, water retention, endothelial dysfunction and possibly other mechanisms.
","Congestive Heart Failure after an acute Myocardial Infarction: The recommended dose of Eplerenone is 50 mg once daily. Treatment should be initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily preferably within 4 weeks as tolerated by the patient. Eplerenone may be administered with or without food.
Hypertension: Eplerenone may be used alone or in combination with other antihypertensive agents. The recommended starting dose of Eplerenone is 50 mg administered once daily. For patients with an inadequate blood pressure response to 50 mg once daily the dosage of Eplerenone should be increased to 50 mg twice daily. Higher dosages of Eplerenone are not recommended either because they have no greater effect on blood pressure than 100 mg or because they are associated with an increased risk of hyperkalemia.
",,"May increase risk of hyperkalaemia with ACE inhibitors and/or angiotension receptor blocker, ciclosporin, tacrolimus, trimethoprim. May reduce antihypertensive effect with NSAIDs, glucocorticoids, tetracosactide. May enhance hypotensive effect of α1-blockers (e.g. alfuzosin, prazosin), TCAs, amifostine, baclofen, neuroleptics. May increase plasma level with mild to moderate CYP3A4 inhibitors (e.g. fluconazole, erythromycin, saquinavir, amiodarone, diltiazem, verapamil).
","Eplerenone is contraindicated in-
+
+- Hyperkalaemia
+- Severe renal impairment (creatinine clearance less than 30 ml/min)
+- Severe hepatic impairment
+- Concomitant use with potent CYP3A4 inhibitors like Ketoconazole, Itraconazole, Nefazodone, Troleandomycin, Clarithromycin, Ritonavir, and Nelfinavir or other
+- Potassium-sparing diuretics are also contraindicated
+
","Headache, dizziness, diarrhea, stomach pain, nausea, cough or flu-like symptoms may occur. Symptoms of a serious allergic reaction like: rash, itching, swelling, severe dizziness, trouble breathing can occur.
","Pregnancy: There are no adequate and well-controlled studies in pregnant women. Eplerenone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: The concentration of Eplerenone in human breast milk after oral administration is unknown. Because many drugs are excreted in human milk and because of the unknown potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
","Eplerenone should be used with caution in hyperkalemia, severe kidney disease, diabetic patients with congestive heart failure after an acute myocardial infarction including those with proteinuria.
","Pediatric use: The safety and effectiveness of Eplerenone has not been established in pediatric patients.
Geriatric use: No differences in overall incidence of effectivity or safety was observed in elderly patients.
","Symptoms: Hyperkalaemia, hypotension.
Management: Symptomatic and supportive treatment. Admin activated charcoal. Initiate standard therapy for hyperkalaemia.
",,,"Store below 30°C in a cool and dry place, protected from light and moisture. Keep out of children’s reach.
",12
+420,Epirubicin Hydrochloride,epirubicin-hydrochloride-420,https://medex.com.bd/attachments/Q1os2SwZAJq8SmMoDZsRzWKlUHRch9/epirubicin-hydrochloride-prescribing-information,Cytotoxic Chemotherapy,Stomach carcinoma,"Epirubicin Injection is an anthracycline topoisomerase II inhibitor indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer
","Cytotoxic Chemotherapy
","Epirubicin, an anthracycline with cytotoxic properties. It inhibits DNA and RNA synthesis by steric obstruction after intercalating between DNA base pairs that triggers DNA cleavage by by topoisomerase II. It also inhibits DNA helicase and generates cytotoxic free radicals.
","Acute leukaemias; Lymphoma; Multiple myeloma; Solid tumours:
+
+- As a single agent: 60-90 mg/m2 3-4 wkly.
+- Max (total cumulative dose): 0.9-1 g/m2.
+- Palliative care: 12.5-25 mg/m2 once wkly.
+
+Adjuvant treatment in axillary-node positive breast cancer: Recommended starting doses: 100-120 mg/m
2 as a single dose on day 1 or as 2 divided doses on days 1 and 8 of each 28-day cycle. Repeat for 6 cycles.
Intravesical Local treatment of bladder carcinoma: As 0.1% soln: 50 mg/wk for 8 wk; reduce dose if chemical cystitis develops.
For carcinoma in-situ: 80 mg in 50 mL wkly.
For prevention of recurrence in patients who have undergone transurethral resection: 50 mg/wk for 4 wk, followed by 50 mg/mth for 11 mth; retain soln in the bladder for 1 hr during each administration.
",,"Paclitaxel and other anthracyclines. Cimetidine, heparin. Antineoplastic drugs, cardiotoxic drugs, radiation, hepatoactive drugs.
","Cardiac impairment, severe or recent Ml; previous full cumulative doses of anthracyclines. Hypersensitivity; severe hepatic dysfunction. Not for intravesical use where invasive tumours have penetrated the bladder wall; urinary infections, bladder inflammation or catheterisation problems. Pregnancy, lactation.
","In early breast cancer, acute adverse events occurring in ≥10% of patients are leucopenia, neutropenia, anemia, thrombocytopenia, amenhorrhea, lethargy, nausea/vomiting, mucositis, diarrhea, infection, conjunctivitis/keratitis, alopecia, local toxicity and rash/itch.
Long term adverse events occurring at a frequency of 1-2% are asymptomatic drops in LVEF and CHF and secondary leukemia.
","Discontinue nursing prior to taking Epirubicin. Not known if excreted in breast milk
","Previous extensive radiotherapy, bone infiltration by tumour, severe renal and hepatic dysfunction. May cause tumor lysis syndrome or radiation recall. Elderly women >70 yr. CV disease, hypertensive cardiomyopathy; monitor hematological and cardiac function regularly. Extravasation during IV admin may result in severe local tissue necrosis. Do not give via IM/SC routes as extravasation can lead to severe local necrosis
",,,,,,9
+419,Epinastine Hydrochloride,epinastine-hydrochloride-419,https://medex.com.bd/attachments/F6hFXkxorAVlhVIr24x5Yj8jAgAQT6/epinastine-hydrochloride-prescribing-information,Ophthalmic Non-Steroid drugs,Conjunctivitis,"Epinastine sterile ophthalmic solution is indicated for the treatment of signs and symptoms of allergic conditions of the anterior segment of the eye.
","Ophthalmic Non-Steroid drugs
","Epinastine is a topically active antihistamine that antagonizes both histamine H1 and H2 receptors. Moreover, it has mast cell stabilizing activity and prevents the release of inflammatory mediators from the blood vessel. Epinastine does not penetrate the blood-brain barrier and therefore is not expected to induce side effects on the central nervous system.
","Instill 1 drop in the affected eye(s) twice daily.
",,,"Contraindicated in patients who are hypersensitive to Epinastine or to any of the components of this preparation.
","The most frequently reported side effects are mild burning sensation, folliculosis, hyperemia, pruritus, cold symptoms and upper respiratory infections.
","There are no adequate and well-controlled studies on pregnant women. Epinastine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Epinastine is excreted in human milk. Caution should be exercised when Epinastine is administered to a nursing mother.
","For ophthalmic use only. Patients should be advised not to wear contact lenses if their eye is red.
","Use in children: Safety and effectiveness in children below the age of 3 years have not been established.
Use in elderly patients: No overall differences in safety and effectiveness have been observed between elderly and other adult patients.
",,,,"Store in a cool & dry place, protect from light. Do not use longer than one month after the first opening. Keep out of the reach of children.
",10
+418,Ephedrine Hydrochloride,ephedrine-hydrochloride-418,https://medex.com.bd/attachments/ZBfYd2Uol2kMvW0AqPBHDC0hlKIedw/ephedrine-hydrochloride-prescribing-information,Other adrenoceptor stimulants,Hypotension,"Ephedrine is indicated to reverse hypotension induced by spinal or epidural anaesthesia. It is of little value in hypotensive crisis due to shock, circulatory collapse, or haemorrhage.
","Other adrenoceptor stimulants, Vasoconstrictor/Venotonic
","Ephedrine is a stimulant drug, belonging to a group of medicines known as sympathomimetics. Specifically it is both an alpha and beta adrenergic agonist. In addition, Ephedrine enhances the release of norepinephrine, a strong endogenous alpha agonist. The action of this compound is notably similar to that of the body's primary adrenergic hormone epinephrine (adrenaline), which also exhibits action toward both alpha and beta receptors. When administered, Ephedrine will notably increase the activity of the central nervous system, as well as have a stimulatory effect on other target cells.
","To reverse hypotension induced by spinal or epidural anaesthesia 3 to 6 mg (or at most 9 mg) Ephedrine Hydrochloride is given by slow intravenous injection and repeated every 3 to 4 minutes as required; the maximum total dose is 30 mg. Ephedrine has also been given by intramuscular or subcutaneous injection.
",,"Administration of Ephedrine may cause a hypertensive crisis in patients receiving an Monoamine Oxidase Inhibitor (including an Reversible Inhibitor of Monoamine Oxidase type A). Ephedrine should be avoided or used with care in patients undergoing anaesthesia with cyclopropane, halothane, or other volatile anaesthetics. An increased risk of arrhythmias may occur if given to patients receiving cardiac glycosides, quinidine, or tricyclic antidepressants, and there is an increased risk of vasoconstrictor or pressor effects in patients receiving ergot alkaloids or oxytocin
","The use of Ephedrine is contraindicated in the presence of coronary thrombosis. It should be used with caution in patients with organic heart disease, cardiac decompensation, hyperthyroidism, hypertension, and angina pectoris, and in patients receiving digitalis.
","Adverse effects reported are nausea, vomiting, anorexia; tachycardia (sometimes bradycardia), arrhythmias, anginal pain, vasoconstriction with hypertension, vasodilation with hypotension, dizziness and flushing; dyspnoea; headache, anxiety, restlessness, confusion, psychoses, insomnia, tremor; difficulty in micturition, urine retention; sweating, hypersalivation; changes in blood-glucose concentration; very rarely angle-closure glaucoma.
","Pregnancy: Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Lactation: Ephedrine Hydrochloride is distributed into breast milk, and therefore Ephedrine Hydrochloride Injection is not recommended for use during lactation because of the risk of adverse effects in the infant.
","Ephedrine should be given with care to patients with hyperthyroidism, diabetes mellitus, ischemic heart disease, hypertension, renal impairment, or angle-close glaucoma. In patients with prostatic enlargement, Ephedrine may increase difficulty with micturition. Use in pregnancy and lactation: Increased fetal heart rate reported with parenteral Ephedrine. Irritability and disturbed sleep have been reported in breast-fed infants.
",,"When given in sufficiently large doses Ephedrine gives rise in most patients to certain minor reactions, such as giddiness, headache, nausea, vomiting, sweating, palpitations, difficulty in micturition, tremors, anxiety, restlessness and insomnia; some patients may exhibit these symptoms even with the usual therapeutic dosage.
",,,"Store in a cool, dry place, protected from light. Keep all medicines out of reach of children.
",11
+417,Eperisone Hydrochloride,eperisone-hydrochloride-417,https://medex.com.bd/attachments/GrchtT0umtTba5xPtGZ6SRVsAa7Bgx/eperisone-hydrochloride-prescribing-information,Centrally acting Skeletal Muscle Relaxants,Rigidity,"Improvement of muscular hypertonic symptoms in the following diseases Cervical syndrome, periarthritis of the shoulder, lumbago. Spastic paralysis in the following disease: Cerebrovascular disease,spastic spinal paralysis, cervical spondylosis, postoperative sequelae (including cerebrospinal tumor) ... Read more
Improvement of muscular hypertonic symptoms in the following diseases Cervical syndrome, periarthritis of the shoulder, lumbago. Spastic paralysis in the following disease: Cerebrovascular disease,spastic spinal paralysis, cervical spondylosis, postoperative sequelae (including cerebrospinal tumor), sequelae to trauma (spinal trauma, head injury), amyotrophic lateral sclerosis, cerebral palsy, spinocerebellar degeneration, spinal vascular diseases and other encephalomyelopathies.
","Centrally acting Skeletal Muscle Relaxants
","Eperisone is centrally-acting skeletal muscle relaxant used to improve myotonic symptoms.
","For adults: Usually 3 tablets per day in three divided doses after each meal. The dosage should be adjusted depending on the patient age and severity of symptoms.
",,"Avoid concomitant use with tolperisone HCl and methocarbamol.
","Eperisone is contraindicated in patients with a history of hypersensitivity to Eperisone Hydrochloride.
","The side effects of Eperisone are very rare, only a few cases have been observed. These are excessive relaxation, stomachache, nausea, vertigo, anorexia, drowsiness, skin rashes, diarrhea, vomiting, indigestion, GI disturbances, insomnia, headache, constipation, etc.
","Eperisone should only be used in pregnant women if the expected therapeutic benefits are evaluated to outweight the possible risks of treatment. The safety of Eperisone has not been established in pregnant women. The drug should not be used during lactation.
",,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+416,Epalrestat,epalrestat-416,https://medex.com.bd/attachments/HZk8tBopVxcKo1ndLI6kHKGjbmuDKw/epalrestat-prescribing-information,Aldose reductase inhibitor,Neuropathy,"Epalrestat consequently improves peripheral neuropathy due to sorbitol accumulation. It is usually used to improve numbness, pain and abnormality of vibration sensation/heart rate variability associated with diabetic peripheral neuropathy.
","Aldose reductase inhibitor
","Epalrestat is aldose reductase inhibitor. The aldose reductase inhibitors have a distinct mechanism of action, affecting the underlying disease process in diabetic neuropathy, although the extent of the polyol pathway involvement is yet to be determined. This medicine suppresses accumulation of sorbitol in cells by inhibiting action of aldose reductase which converts glucose of sugar to sorbitol. Epalrestat may improve motor and sensory nerve conduction velocity and subjective neuropathy symptoms.
","In general, for adults, take 1 tablet (50 mg of the active ingredient) at a time, 3 times a day before meals. The dosage may be adjusted according to your age and symptoms.
",,"There are no known drug interactions and none well documented.
","
+- If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
+- If you are pregnant or breastfeeding.
+- If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
+
","The most commonly reported adverse reactions include abdominal pain, nausea, rash, itch, erythema and blister.
","Pregnancy category is not classified. FDA has not yet classified the drug into a specified pregnancy category
","Your urinary color may turn yellowish brown or red due to color of the component of this medicine. Do not worry about the change.
",,,,,"Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
",10
+413,Entecavir,entecavir-413,https://medex.com.bd/attachments/7xmwJ12VQEjTnOK9dLQhCsRps7R7VJ/entecavir-prescribing-information,Hepatic viral infections (Hepatitis B),Chronic hepatitis B,"Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevation in serum aminotransferases (ALT or AST) or histologically active disease.
","Hepatic viral infections (Hepatitis B)
","By competing with the natural substrate deoxyguanosine triphosphate, entecavir functionally inhibits all three activities of the HBV polymerase (reverse transcriptase, rt):
+
+- Base priming,
+- Reverse transcription of the negative strand from the pregenomic messenger RNA, and
+- Synthesis of the positive strand of HBV DNA. Upon activation by kinases, the drug can be incorporated into the DNA which has the ultimate effect of inhibiting the HBV polymerase activity.
+
","The recommended dose of Entecavir for chronic hepatitis B virus infection in nucleoside-treatment-naive adults and adolescents 16 years of age is 0.5 mg once daily. For Lamivudine-refractory or known Lamivudine or Telbivudine resistance mutations, the recommended dose of Entecavir is 1 mg once daily. For patients with decompensated liver disease (adult) the recommended dose of Entecavir is 1 mg once daily. Entecavir should be administered on an empty stomach (at least 2 hours after a meal or 2 hours before the next meal).
Missed Dose: If it is almost time for next dose, skip the missed dose and take the next dose at the proper time. Nobody should take a double dose to make up for the missed dose.
",,"Co-administration of Entecavir with Lamivudine or Adefovir dipivoxil did not result in significant drug interactions. The effects of co-administration of Entecavir with other drugs that are eliminated through renal or are known to affect renal function have not been evaluated and patients should be monitored closely for adverse events when coadministered with such drugs.
","Entecavir is contraindicated in patients with previously demonstrated hypersensitivity to Entecavir or any component of the product.
","The most common adverse events are headache, fatigue, dizziness and nausea.
","There are no data on the effect of Entecavir on the transmission of HBV from mother to infant. Therefore, appropriate care should be taken. It is not known whether it is excreted in human milk. Mothers should be instructed not to breastfeed if they are taking Entecavir.
","Lactic acidosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals.
Exacerbations of hepatitis after discontinuation of treatment: Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including Entecavir.
","Pediatric: Safety and effectiveness of Entecavir in pediatric patients below the age of 2 years have not been established.
Geriatric: Clinical studies of Entecavir did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. But care should be taken in dose selection, and it may be useful to monitor renal function.
Dose adjustment in renal impairment: Dose adjustment is recommended for patients with CrCl <50 ml/min including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) as shown below:
+
+- CrCl ≥50 ml/min: 0.5 mg every 24 hours
+- CrCl 30 to <50 ml/min: 0.5 mg every 48 hours
+- CrCl 10 to <30 ml/min: 0.5 mg every 72 hours
+- CrCl <10 ml/min or Hemodialysis or CAPD: 0.5 mg every 7 days
+
","There is no experience of Entecavir overdosage reported in patients. Healthy subjects who received up to 20 mg daily for up to 14 days and single doses up to 40 mg had no unexpected adverse events. If overdosage occurs, the patient must be monitored for evidence of toxicity and standard supportive treatment as necessary.
",,,"Keep in a dry place and store below 30°C. Protect from light and keep out of the reach of children.
",12
+412,Entacapone,entacapone-412,https://medex.com.bd/attachments/5O8W8HfKsz2rZhaHvBaIFvElHvMZHY/entacapone-prescribing-information,Antiparkinson drugs,Parkinson’s disease,"Adjunct to levodopa treatment in Parkinson's disease
","Antiparkinson drugs
","Entacapone decreases the metabolic loss of levodopa to 3-O-methyldopa (3-OMD) through inhibition of COMT enzyme leading to an increased levodopa concentration, thus, extending the duration and effect in the brain.
","200 mg with each levodopa/dopa decarboxylase inhibitor dose. Max: 200 mg 10 times daily (2,000 mg daily). Gradually reduce levodopa dose by approx 10-30% or increase dosing interval w/in the 1st few wk of starting treatment.
May be taken with or without food.
",,"May interfere with metabolism of other drugs metabolised by COMT (e.g. rimiterole). May aggravate levodopa-induced orthostatic hypotension. Risk of dopaminergic effects with dopamine agonists (e.g. bromocriptine), selegiline, amantadine. May form chelates with Fe in the GI tract. Additive sedative effects with other CNS depressants.
","Phaeochromocytoma, history of neuroleptic malignant syndrome and/or non-traumatic rhabdomyolysis. Hepatic impairment. Concomitant use w/ non-selective MAOIs.
","Abdominal pain, nausea, vomiting, diarrhoea, constipation, colitis, dry mouth, dyskinesia, dizziness, nightmares, insomnia, hallucinations, confusion, fatigue, increased sweating, behavioural disturbances; urine, skin, hair, beard and nail discolourations; cholestatic hepatitis, rhabdomyolysis. Rarely, agitation, urticaria, erythematous or maculopapular rash, anorexia, wt decrease, increased liver enzymes.
","Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Patient with biliary obstruction, ischaemic heart disease. Avoid abrupt withdrawal. Pregnancy and lactation.
",,"Symptoms: Decreased activity, confusion, somnolence, hypotonia, urticaria, skin discolouration.
Management: Symptomatic treatment.
",,,"Store at 25°C.
",11
+411,Enoxaparin Sodium,enoxaparin-sodium-411,https://medex.com.bd/attachments/hq90Iw15d5UXhNMJwFK4n7eWo1fxJh/enoxaparin-sodium-prescribing-information,Parenteral anti-coagulants,Venous thromboembolism,"Enoxaparin is indicated in:
+
+- Treatment of deep vein thrombosis, with or without pulmonary embolism.
+- Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin.
+- Prevention of thrombus formation in the extra-corporal circulation during haemodialysis.
... Read more
Enoxaparin is indicated in:
+
+- Treatment of deep vein thrombosis, with or without pulmonary embolism.
+- Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin.
+- Prevention of thrombus formation in the extra-corporal circulation during haemodialysis.
+- Prophylaxis of venous thromboembolic disease (prevention of blood clot formation in the veins), in particular those which may be associated with orthopedic or general surgery.
+- Prophylaxis of venous thromboembolic disease in medical patients bedridden due to acute illness, including cardiac insufficiency, respiratory failure, severe infections, rheumatic diseases.
+
","Parenteral anti-coagulants
","Enoxaparin Sodium is a low molecular weight heparin with a high anti-Xa activity and low anti-lla or antithrombin activity. At doses required for the various indications, Enoxaparin Sodium does not increase bleeding time. At preventive doses, Enoxaparin Sodium causes no notable modification of activated Partial Thromboplastin Time (aPTT). It neither influences platelet aggregation nor binding of fibrinogen to platelets. Enoxaparin Sodium is primarily metabolised in the liver.
","Treatment of deep vein thrombosis, with or without pulmonary embolism: Subcutaneously 100 anti-Xa lU/kg twice daily for 10 days or Subcutaneously 150 anti-Xa lU/kq once daily for 10 days. Oral anticoagulant therapy should be initiated when appropriate and Enoxaparin Sodium treatment should be continued until a therapeutic anticoaqulant effect has been achieved.
Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin: Subcutaneously 100 anti-Xa lU/kg twice daily for 2- 8 days. Should be administered concurrently with oral aspirin (100 to 325 mg once daily). Treatment with Enoxaparin Sodium in these patients should be prescribed fora minimum of 2 days and continued until clinical stabilization.
Prevention of thrombus formation in extra corporeal circulation during hemodialysis: Recommended dose is 100 anti-Xa lU/kg. For patients with a high risk of hemorrhage, the dose should be reduced to 50 anti-Xa lU/kg for double vascular access or 75 anti-Xa lU/kg for single vascular access. During hemodialysis, Enoxaparin Sodium should be introduced into the arterial line of the circuit at the beqinninq of the dialysis session.
Prophylaxis of venous thromboembolic disease in surgical patients:
+
+- Patients undergoing general surgery with a moderate risk of thromboembolism (e.g. abdominal surgery): Subcutaneously 2000 anti-Xa IU (0.2 ml) or 4000 anti-Xa IU (0.4 ml) once daily for 7 to 10 days. The first injection should be given 2 hours before the surgical procedure.
+- Patients undergoing orthopedic surgery with a high risk of thromboembolism: Subcutaneously 4000 anti-Xa IU (0.4 ml) once daily for 7 to 10 days. The first injection should be given 12 hours before the surgical procedure. Longer treatment duration may be appropriate in some patients like continued therapy with 4000 anti-Xa IU once daily for 3 weeks following the initial therapy has been proven to be beneficial in orthopaedic surqery.
+
+
Prophylaxis of venous thromboembolic disease in medical patients: Subcutaneously 4000 anti-Xa IU (0.4 ml) once daily for 6- 14 days.
",,"It is recommended that agents which affect hemostasis should be discontinued prior to Enoxaparin Sodium therapy unless strictly indicated. These agents include medications such as: acetylsalicylic acid (and derivatives), NSAIDs (including ketorolac), ticlopidine,clopidogrel,dextran 40,glucocorticoids, thrombolytics and anticoagulants, other antiplatelet aggregation agents including glycoprotein llb/llla antagonists. If the combination is indicated, should be used with careful clinical and laboratory monitoring.
","Patients with known hypersensitivity to Enoxaparin Sodium, heparin or other low molecular weight heparins. Patients with active major bleeding and conditions with a high risk of uncontrolled hemorrhage including recent hemorrhagic stroke.
","Haemorrhage (bleeding), Thrombocytopenia, elevations of serum aminotransferase. Pain, bluish marks at injection sites to skin rash at injection sites. Cases of neuraxial hematomas with the concurrent use of Enoxaparin and spinal/epidural anesthesia or spinal puncture have resulted in varying degrees of neurologic injuries.
","Pregnancy category B. In humans, there is no evidence that Enoxaparin Sodium crosses the placental barrier. As there are no adequate and well-controlled studies in pregnant women, Enoxaparin Sodium should be used during pregnancy only if clearly needed. Pregnant women with mechanical prosthetic heart valves may be at a higher risk for thromboembolism.
It is not known whether Enoxaparin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue Enoxaparin, taking into account the importance of Enoxaparin to the mother and the known benefits of nursing.
","Enoxaparin Sodium should be injected by deep subcutaneous route in prophylactic and curative treatment and by intravascular route during hemodialysis. Do not administer by the intramuscular route. Enoxaparin Sodium should be used with caution in conditions with increased potential for bleeding, such as impaired hemostasis, history of peptic ulcer, recent ischemic stroke, uncontrolled severe arterial hypertension, diabetic retinopathy and recent neuro- or ophthalmologic surgery, concomitant use of medications affecting hemostasis. It is recommended that the platelet counts be measured before the initiation of the treatment and regularly thereafter during treatment.
","Dose in Elderly Patients: No dosage adjustment is necessary, unless kidney function is impaired.
Dose in Renal Impairment: Although no dosage adjustment is recommended in patients with moderate (creatinine clearance: 30-50 ml/min) and mild (creatinine clearance: 50 80 ml/min) renal impairment, all such patients should be observed carefully for signs and symptoms of bleeding. For patients with severe (creatinine clearance <30 ml/min) renal impairment, following dosage adjustments are recommended: Prophylactic dose ranges: 2000 antiXa IU once daily; Therapeutic dose ranges: 100 anti-Xa lU/kg once daily.
Dose in Hepatic Impairment: Caution should be used in hepatically impaired patients.
","Accidental overdosage following administration of Enoxaparin may lead to hemorrhagic complications. Injected Enoxaparin may be largely neutralized by the slow i.v. injection of protamine sulfate (1% solution) The dose of protamine sulfate should be equal to the dose of Enoxaparin injected: 1 mg protamine sulfate should be administered to neutralize 1 mg Enoxaparin.
",,,"Store in a cool and dry place, protect from light and moisture. Do not store above 25°C. Do not store in a refrigerator or freezer. Keep out of the reach of children
",12
+1556,Encephalitis Vaccine,encephalitis-vaccine-1556,https://medex.com.bd/attachments/P0qrh5mZeHah1D79Xs5uOIr3cwcAmV/encephalitis-vaccine-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Encephalitis virus vaccine,"Encephalitis Vaccine is indicated for active immunisation against Japanese encephalitis in adults, adolescents, children and infants aged 2 months and older. Encephalitis Vaccine should be considered for use in individuals at risk of exposure through travel or in the course of their occupation.
","Vaccines, Anti-sera & Immunoglobulin
","The mechanism of action of Japanese encephalitis (JE) vaccines is not well understood. Studies in animals have shown that the vaccine triggers the immune system to produce antibodies against Japanese encephalitis virus that are most often protective. Challenge studies were performed in mice that were treated with human Encephalitis Vaccine antisera. These studies showed that almost all mice that had a Plaque Reduction Neutralization Test titre of at least 1:10 were protected from a lethal Japanese encephalitis virus challenge.
","Adults (18 to ≤ 65 years of age): The primary vaccination series consists of two separate doses of 0.5 ml each, according to the following conventional schedule:
+
+- First dose: Day 0.
+- Second dose: 28 days after first dose.
+
+Rapid schedule: Persons aged 18 to ≤65 years can be vaccinated in a rapid schedule as follows:
+
+- First dose: Day 0.
+- Second dose: 7 days after first dose.
+
+With both schedules, primary immunisation should be completed at least one week prior to potential exposure to Japanese encephalitis virus (JEV). It is recommended that vaccinees who received the first dose of Encephalitis Vaccine complete the primary 2-dose vaccination course with Encephalitis Vaccine. If the primary immunization of two injections is not completed, full protection against the disease might not be achieved. There is data that a second injection given up to 11 months after the first dose results in high seroconversion rates.
Booster dose: A booster dose (third dose) should be given within the second year (i.e. 12-24 months) after primary immunization, prior to potential re-exposure to JEV. Persons at continuous risk for acquiring Japanese encephalitis (laboratory personnel or persons residing in endemic areas) should receive a booster dose at month 12 after primary immunization. Long-term seroprotection data following a first booster dose administered 12-24 months after primary immunization suggest that a second booster should be given 10 years after the first booster dose, prior to potential exposure to JEV.
Elderly (>65 years of age): The primary vaccination series consists of two separate doses of 0.5 ml each, according to the following conventional schedule:
+
+- First dose: Day 0.
+- Second dose: 28 days after first dose.
+
+
Pediatric Population:
Children and adolescents from 3 years to <18 years of age: The primary vaccination series consists of two separate doses of 0.5 ml according to the following schedule:
+
+- First dose: Day 0.
+- Second dose: 28 days after first dose.
+
+Children from 2 months to <3 years of age: The primary vaccination series consists of two separate doses of 0.25 ml according to the following schedule:
+
+- First dose: Day 0.
+- Second dose: 28 days after first dose.
+
","The vaccine should be administered by intramuscular injection into the deltoid muscle. In infants, the anterolateral aspect of the thigh may be used as injection site. Encephalitis Vaccine should never be injected intravascularly. When Encephalitis Vaccine is administered concomitantly with injectable vaccines, they should be given with separate syringes at opposite sites. Exceptionally, Encephalitis Vaccine can also be administered subcutaneously to patients with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration. Subcutaneous administration could lead to a suboptimal response to the vaccine. However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route.
",,"Hypersensitivity to the active substance or to any of the excipients or to the residues protamine sulphate, formaldehyde, bovine serum albumin, host cell DNA, sodium metabisulphite, host cell protein. Individuals who show hypersensitivity reactions after receiving the first dose of the vaccine should not be given the second dose. Administration must be postponed in persons with acute severe febrile conditions.
","Very common: headache, muscle pain, injection site pain, injection site tenderness, tiredness.
Common: Nausea, influenza like illness, fever, other injection site reactions (e.g. redness, hardening, swelling, itching).
Uncommon: vomiting, skin rash, changes in the lymph-nodes, migraine (throbbing headache, often accompanied by nausea and vomiting and sensitivity to light), dizziness, vertigo (spinning sensation), diarrhoea, belly pain, excessive sweating, itching, chills, general condition of feeling unwell, musculoskeletal stiffness, joint pain, weakness, abnormal laboratory liver test results (hepatic enzymes increased).
","Pregnancy: There are limited amount of data from the use of Encephalitis Vaccine in pregnant women. In animal studies findings of unclear clinical relevance have been identified. As a precautionary measure, the use of Encephalitis Vaccine during pregnancy should be avoided.
Breast-feeding: It is unknown whether Encephalitis Vaccine is excreted in human milk. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to Encephalitis Vaccine is negligible. However, in the absence of data and as a precautionary measure the use of Encephalitis Vaccine during lactation should be avoided.
Fertility: A study in rats did not indicate vaccine-related effects on female reproduction, foetal weight, survival and development of the off-spring.
",,"Children below 2 months of age: The safety and efficacy of Encephalitis Vaccine in children younger than 2 months has not been established. No data are available.
",,,,"Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original package in order to protect from light.
",10
+409,Enalapril Maleate,enalapril-maleate-409,https://medex.com.bd/attachments/Rrl8HbmCmIQB2N60PPwOnf6MLGAY9u/enalapril-maleate-prescribing-information,Angiotensin-converting enzyme (ACE) inhibitors,Hypertension,"Enalapril is indicated in-
+
+- All grades of essential hypertension and renovascular hypertension either alone or in combination with other antihypertensive agents especially thiazide diuretics.
+- Prevention of symptomatic heart failure.
+- Treatment of congestive heart failure (adjunct), usually in combination with diuretics and digitalis.
... Read more
Enalapril is indicated in-
+
+- All grades of essential hypertension and renovascular hypertension either alone or in combination with other antihypertensive agents especially thiazide diuretics.
+- Prevention of symptomatic heart failure.
+- Treatment of congestive heart failure (adjunct), usually in combination with diuretics and digitalis.
+- Prevention of coronary ischaemic events in patients with left ventricular dysfunction.
+
+Enalapril is also used either alone or as an adjunct in the treatment of angina, diabetic nephropathy and Raynaud's disease.
","Angiotensin-converting enzyme (ACE) inhibitors
","Enalapril, after hydrolysis to enalaprilate, inhibits Angiotensin Converting Enzyme (ACE). ACE is a peptidyl dipeptidase that catalyses the conversion of angiotensin I to the vasoconstrictor substance angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. The beneficial effects of enalapril in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin aldosterone system
","Hypertension: Initially 5 mg once daily if used alone or 2.5 mg daily if used in addition to diuretic, in elderly patients or in patients with renal impairment. Usual maintenance dose is 10-20 mg once daily. However, in severe hypertension it may be increased to a maximum of 40 mg once daily.
Heart failure (adjunct) and asymptomatic left ventricular dysfunction: Initially 2.5 mg under close medical supervision. Usual maintenance dose is 20 mg daily in 1-2 divided doses
",,"Combination with other antihypertensive agents such as b blockers, Methyldopa, calcium antagonists and diuretics may increase the antihypertensive efficacy. Adrenergic blocking drugs should only be combined with Enalapril under careful supervision. Concomitant Propranolol may reduce the bioavailability of Enalapril, but this does not appear to be of any clinical significance. Concomitant therapy with Lithium may increase the serum Lithium concentration.
","Aortic stenosis or outflow tract obstruction. Renovascular disease. Severe resistant HTN. Peripheral vascular disease or generalized atherosclerosis.
","Dizziness and headache are more commonly reported side effects. Fatigue and asthenia were reported in 2-3% of patients. Other side effects occurred in less than 2% of patients and included hypotension, orthostatic hypotension, syncope, nausea, diarrhoea, muscle cramps, rash and cough.
Less frequently renal dysfunction, renal failure and oliguria have been reported. Angioedema, hyperkalemia and hyponatremia have also been reported rarely
","Category D: Contraindicated in pregnancy. The drug is excreted in trace amount in human milk and caution should be exercised if given to nursing mothers.
","Assess renal function; regular WBC counts in patient w/ collagen vascular disease eg SLE & scleroderma. Patient receiving immunosuppressive therapy; those prone to salt or water depletion. Pregnancy.
","Use in the elderly (over 65 years): The starting dose should be 2.5 mg. Enaril is effective in the treatment of hypertension in the elderly. The dose should be titrated according to need for the control of blood pressure.
","symptoms-
+
+- Lightheadedness, dizziness, or fainting
+- Decrease in urine output
+- Drowsiness, headache, or back pain
+- Slow or irregular heartbeat.
+
+
Management-
+
+- Fluids through an intravenous line (IV)
+- Medications to increase blood pressure
+- Other treatments based on complications that occur
+- Closely monitoring the heart and lungs.
+
",,,,11
+1580,Empagliflozin + Metformin Hydrochloride,empagliflozin-metformin-hydrochloride-1580,https://medex.com.bd/attachments/dZKPUe8Tgnw7rnj1wNBTUrVF3UnHAg/empagliflozin-metformin-hydrochloride-prescribing-information,Combination Oral hypoglycemic preparations,Type 2 DM,"This tablet is indicated for the treatment of adults with type 2 diabetes mellitus as an adjunct to diet and exercise:
+
+- In patients insufficiently controlled on their maximally tolerated dose of Metformin alone
+- In combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with Metformin and these medicinal products
... Read more
This tablet is indicated for the treatment of adults with type 2 diabetes mellitus as an adjunct to diet and exercise:
+
+- In patients insufficiently controlled on their maximally tolerated dose of Metformin alone
+- In combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with Metformin and these medicinal products
+- In patients already being treated with the combination of Empagliflozin and Metformin as separate tablets.
+
","Combination Oral hypoglycemic preparations
","Empagliflozin is an inhibitor of Sodium-Glucose Co-Transporter 2 (SGLT2). SGLT2 is the predominant transporter, responsible for reabsorption of glucose from the kidney back into the circulation. By inhibiting SGLT2, Empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose and thereby increases urinary glucose excretion.
Metformin Hydrochloride is a biguanide type oral antihyperglycemic drug, used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. It does not produce hypoglycemia. Metformin Hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
","The dosage should be individualized based on effectiveness and tolerability. Take this combination twice daily with meals. Dose escalation should be gradual to reduce the gastrointestinal side effects due to Metformin Hydrochloride. Maximum recommended daily dose of Metformin Hydrochloride is 2000 mg and Empagliflozin is 25 mg.
Recommended individualized starting dose:
+
+- In patients on Metformin Hydrochloride, switch to this combination containing Empagliflozin 5 mg with a similar total daily dose of Metformin Hydrochloride.
+- In patients on Empagliflozin, switch to this combination containing Metformin Hydrochloride 500 mg with a similar total daily dose of Empagliflozin.
+- In patients already treated with Empagliflozin and Metformin Hydrochloride separately switch to this combination containing the same total daily doses of each component.
+- In patients with volume depletion not previously treated with Empagliflozin, correct this condition before initiating this combination.
+
+
Renal impaired patient: Assess renal function before initiating this combination. In patients with an eGFR below 45 mL/min/1.73 m
2 is contraindicated.
Pediatric patients under 18 years of age: Safety and effectiveness in pediatric patients under 18 years of age have not been established.
",,"Diuretics: Co-administration of Empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.
Insulin or Insulin Secretagogues: Co-administration of Empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia.
Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.
Drugs that Reduce Metformin Clearance: Drugs that reduce Metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of Metformin.
Carbonic Anhydrase Inhibitors: Carbonic anhydrase inhibitors may increase risk of lactic acidosis.
Drugs Affecting Glycemic Control: Thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid produce hoperglycemia. When such drugs are administered to a patient receiving Empagliflozin and Metformin combination, the patient should be closely observed to maintain adequate glycemic control. When such drugs are withdrawn from a patient receiving Empagliflozin and Metformin combination, the patient should be observed closely for hypoglycemia.
Alcohol: Alcohol can potentiate the effect of Metformin on lactate metabolism. Warn patients against excessive alcohol intake.
","
+- Hypersensitivity to Empagliflozin and Metformin
+- Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)
+- Diabetic pre-coma
+- Severe renal failure (GFR <30 ml/min)
+- Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock
+- Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction, shock
+- Hepatic impairment, acute alcohol intoxication, alcoholism
+
","Most common adverse reactions associated with Empagliflozin (5% or greater incidence) were urinary tract infection and female genital mycotic infections. Most common adverse reactions associated with Metformin (>5%) are diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache. The following important adverse reactions are given below:
+
+- Very common: Hypoglycemia (when used with sulphonylurea or insulin), Gastrointestinal symptoms
+- Common: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection. Urinary tract infection (including pyelonephritis and urosepsis), thirst, taste disturbance, pruritus (generalised), rash, Increased urination, serum lipids increased
+- Uncommon: Volume depletion, urticaria, dysuria, blood creatinine increased/Glomerular filtration rate decreased, Haematocrit increased
+- Rare: Diabetic ketoacidosis.
+
","Advise females of the potential risk to a fetus especially during the second and third trimesters. This is not recommended when breastfeeding.
","Lactic Acidosis: Postmarketing cases of Metformin Hydrochloride-associated lactic acidosis. If lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of this combination.
Hypotension: Before initiating this combination assess and correct volume status in patients with renal impairment, the elderly, in patients with low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms of hypotension after initiating therapy and increase monitoring in clinical situations where volume contraction is expected.
Ketoacidosis: Before initiating this combination assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue this combination, evaluate and treat promptly.
Acute kidney injury & impairment in renal function: Consider temporarily discontinuing this combination in settings of reduced oral intake or fluid losses. If acute kidney injury occurs, discontinue this combination promptly and institute treatment.
Urosepsis, Pyelonephritis, Fournier’s gangrene & Genital mycotic infections: Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.
Hypoglycemia: Consider lowering the dose of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating this combination.
Vitamin B12 Deficiency: Metformin Hydrochloride may lower vitamin B12 levels. Monitor hematologic parameters annually.
Increased LDL-C: Monitor and treat as appropriate.
Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with this combination.
",,"In controlled clinical studies single doses of up to 800 mg Empagliflozin (equivalent to 32-times the highest recommended daily dose) in healthy volunteers and multiple daily doses of up to 100 mg Empagliflozin (equivalent to 4-times the highest recommended daily dose) in patients with type 2 diabetes did not show any toxicity. Hypoglycaemia has not been seen with Metformin doses of up to 85 g, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. In the event of an overdose, treatment should be initiated as appropriate to the patient's clinical status. The most effective method to remove lactate and Metformin is haemodialysis. The removal of Empagliflozin by haemodialysis has not been studied
",,,"Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.
",11
+2046,Empagliflozin + Linagliptin,empagliflozin-linagliptin-2046,https://medex.com.bd/attachments/1bgiqm3lrFyZbhwO5KBTpUtLZgybUs/empagliflozin-linagliptin-prescribing-information,,,"This is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Empagliflozin is indicated to reduce ... Read more
This is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.
",,"Empagliflozin: Sodium-glucose co-transporter 2 (SGLT2) is the predominant transporter responsible for the reabsorption of glucose from the glomerular filtrate back into the circulation. Empagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increasing urinary glucose excretion.
+
+
Linagliptin: Linagliptin is an inhibitor of DPP-4, an enzyme that degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Thus, linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation. Both incretin hormones are involved in the physiological regulation of glucose homeostasis. Incretin hormones are secreted at a low basal level throughout the day and levels rise immediately after meal intake. GLP-1 and GIP increase insulin biosynthesis and secretion from pancreatic beta cells in the presence of normal and elevated blood glucose levels. Furthermore, GLP-1 also reduces glucagon secretion from pancreatic alpha cells, resulting in a reduction in hepatic glucose output.
","Assess renal function before initiating and as clinically indicated. The recommended dose of this is 10 mg empagliflozin and 5 mg linagliptin once daily, taken in the morning, with or without food. Dose may be increased to 25 mg empagliflozin and 5 mg linagliptin once daily.
Pediatric Patients: The safety and effectiveness in pediatric patients have not been established.
Geriatric Patients: Higher incidence of adverse reactions related to volume depletion and reduced renal function.
Renal Impairment: Higher incidence of adverse reactions related to reduced renal function.
",,,,"The most common side effects are:
+
+- urinary tract infection
+- stuffy or runny nose and sore throat
+- upper respiratory tract infection
+
","Advise females of the potential risk to a fetus, especially during the second and third trimesters. This is not recommended when breastfeeding.
","Pancreatitis: There have been reports of acute pancreatitis, including fatal pancreatitis. If pancreatitis is suspected, promptly discontinue this tablet.
Ketoacidosis: Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue this tablet, evaluate and treat promptly. Before initiating this tablet, consider risk factors for ketoacidosis. Patients on this tablet may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.
Volume Depletion: Before initiating this tablet, assess volume status and renal function in patients with impaired renal function, elderly patients, or patients on loop diuretics. Monitor for signs and symptoms during therapy.
Urosepsis and Pyelonephritis: Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.
Hypoglycemia: Consider lowering the dose of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating this tablet.
Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Serious, life-threatening cases have occurred in both females and males. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment.
Genital Mycotic Infections: Monitor and treat as appropriate.
Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema, and exfoliative skin conditions) have occurred with empagliflozin and linagliptin. If hypersensitivity reactions occur, discontinue this tablet, treat promptly, and monitor until signs and symptoms resolve.
Arthralgia: Severe and disabling arthralgia has been reported in patients taking DPP-4 inhibitors. Consider as a possible cause for severe joint pain and discontinue drug if appropriate.
Bullous Pemphigoid: There have been reports of bullous pemphigoid requiring hospitalization. Tell patients to report the development of blisters or erosions. If bullous pemphigoid is suspected, discontinue this tablet.
Heart Failure: Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of this tablet in patients who have known risk factors for heart failure. Monitor for signs and symptoms.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",7
+1275,Empagliflozin,empagliflozin-1275,https://medex.com.bd/attachments/uSY4XDq0cTuR3mJswmoKMRQc22cP8Z/empagliflozin-prescribing-information,Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors,Type 2 DM,"Empagliflozin is indicated in:
+
+- As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
+- To reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease.
+
","Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors
","Empagliflozin is a sodium glucose co-transporter-2 (SGLT-2) inhibitor. SGLT2 co-transporters are responsible for reabsorption of glucose from the glomerular filtrate in the kidney. The glucuretic effect resulting from SGLT2 inhibition reduces renal absorption and lowers the renal threshold for glucose, resulting in increased glucose excretion. Additionally, it contributes to reduced hyperglycaemia, assists weight loss, and reduces blood pressure.
","The recommended dose of Empagliflozin is 10 mg once daily, taken in the morning, with or without food. In patients tolerating Empagliflozin, the dose may be increased to 25 mg once daily. In patients with volume depletion, correcting this condition prior to initiation of Empagliflozin is recommended.
",,"Diuretics: Co-administration of Empagliflozin with diuretics resulted in increased urine volume.
Insulin or Insulin Secretagogues: Co-administration of Empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia.
Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.
Interference with 1,5-anhydroglucitol (1,5-AG) Assay: Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.
","Empagliflozin is contraindicated in patients with history of serious hypersensitivity reaction to Empagliflozin or any of its ingredients, severe renal impairment, end-stage renal disease, or dialysis.
","The most common adverse reactions associated with Empagliflozin are urinary tract infections and female genital mycotic infections. Others common side effects includes dehydration, hypotension, weakness, dizziness and increased thirstiness.
","There are no adequate and well-controlled studies of Empagliflozin in pregnant women. Empagliflozin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Empagliflozin is excreted in human milk. It is not recommended when breastfeeding.
","Assessment of renal function is recommended prior to initiation of Empagliflozin and periodically thereafter. Empagliflozin should not initiated in patients with an eGFR less than 45 ml/min/1.73 m2. No dose adjustment is needed in patients with an eGFR greater than or equal to 45 ml/min/1.73 m2.
",,"In the event of an overdose with Empagliflozin the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, perform clinical monitoring, and institute supportive treatment) should be employed. Removal of Empagliflozin by hemodialysis has not been studied.
",,,"Keep in a cool & dry place (below 30° C), protected from light & moisture. Keep out of the reach of children.
",11
+415,Emollient [Cepalin+Allantoin],emollient-cepalinallantoin-415,,Emollients & combined preparations,Skin moisturization,"Relief of dry skin associated with contact dermatitis, senile pruritus, atopic dermatitis, ichthyosis & related dry skin conditions.
","Emollients & combined preparations
","It softens and hydrates skin. It is also a mild cleanser for dry, sensitive skin. It helps reduce dryness and leaves the skin feeling soft and smooth.
","Parents of children with eczema should try to bathe their child in an emollient wash product once a day. Emollient creams should be used frequently; the weekly recommended amount for children is 250 g per week. On a day to day basis, it is recommended to apply an emollient cream at least 3 to 4 times a day. Add a bath emollient to the water to help prevent the skin from drying out. After bathing, apply an emollient cream to all areas of the skin to lock in the moisture Apply an emollient cream about 20 minutes before bedtime to allow it to soak in to the skin
",,"There are no known drug interactions and none well documented.
","Patients with a history of hypersensitivity to any of the components of the preparation. Acne or greasy skin.
","Skin irritation in people hypersensitive to any of the ingredients.
","Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","This preparation is for external use only. Avoid contact with the eyes. This preparation contains cetostearyl alcohol and potassium sorbate which may cause skin irritation. Discontinue use if skin irritation occurs.
",,,,,,9
+1469,Eluxadoline,eluxadoline-1469,https://medex.com.bd/attachments/R2aEHfVfvCOPORzW3blpKS38pZSDX1/eluxadoline-prescribing-information,Prokinetic drugs,Reduce peristalsis,"Eluxadoline is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).
","Carboxylic acids and derivatives, Prokinetic drugs
","Eluxadoline is a mu-opioid receptor agonist, kappa opioid receptor agonist & delta opioid receptor antagonist. Eluxadoline works directly in intestine to reduce peristalsis, also makes the nerves in intestine less sensitive to stimulation.
","The recommended dosage in adults is 100 mg twice daily taken with food.
The recommended dosage is 75 mg twice daily taken with food in patients who:
+
+- are unable to tolerate the 100 mg dose.
+- are receiving concomitant OATP1B1 inhibitors.
+- have mild or moderate hepatic impairment.
+
+Discontinue Eluxadoline in patients who develop severeconstipation.
If a dose is missed, take the next dose at the regular time; do not take 2 doses at once
",,"Oral Contraceptive, Cyclosporine, Probenecid, Rosuvastatin.
","Known or suspected biliary duct obstruction, sphincter of oddi disease or dysfunction & pancreatitis.
","Most common adverse reactions are constipation, nausea and
abdominal pain.
","Pregnancy: Not established.
Lactation: Not established.
","Sphincter of Oddi spasm and Pancreatitis.
Patients who should be monitored closely-
+
+- without a gallbladder
+- with new or worsening abdominal pain
+- with nausea and vomiting
+- with acute biliary pain
+- with liver or pancreatic enzyme elevation
+
","Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Hepatic Impairment: It is contraindicated in patients with severe hepatic impairment.
",,,,"Store in a cool & dry place, protect from light. Keep out of the reach of children.
",11
+414,Eltrombopag Olamine,eltrombopag-olamine-414,https://medex.com.bd/attachments/z74VnBaq0pLKbcGYUb3TwQt61XnU91/eltrombopag-olamine-prescribing-information,Haemostatic drugs,Idiopathic thrombocytopenic purpura,"Eltrombopag Olamine is indicated in Chronic Immune (Idiopathic) Thrombocytopenia, Chronic Hepatitis C-associated Thrombocytopenia, Severe Aplastic Anemia.
","Haemostatic drugs
","Eltrombopag is an orally bioavailable, small-molecule TPO-receptor agonist that interacts with the transmembrane domain of the human TPO-receptor. Eltrombopag is a stimulator of STAT and JAK phosphorylation. Unlike recombinant TPO or romiplostim, Eltrombopag does not activate the AKT pathway in any way. It should be noted that when given to patients with aplastic anemia, other lineages besides platelet count were increased, suggesting that either eltrombopag enhanced the effect of TPO in vivo; or there is a yet uncovered mechanism of action at work.
","Chronic Immune (Idiopathic) Thrombocytopenia-
+
+- Adult and Pediatric Patients 6 Years and Older with ITP: Initiate Eltrombopag at a dose of 50 mg once daily, except in patients who are of East Asian ancestry (such as Chinese, Japanese, Taiwanese or Korean) or who have mild to severe hepatic impairment (Child-Pugh Class A,B,C). For patients of East Asian ancestry with ITP, initiate Eltrombopag at a reduced dose of 25 mg once daily. For patients with ITP and mild, moderate or severe hepatic impairment (Child-Pugh Class A,B,C), initiate Eltrombopag at a reduced dose of 25 mg once daily.
+- For patients of East Asian ancestry with ITP and hepatic impairment (Child-Pugh Class A,B,C), consider initiating Eltrombopag at a reduced dose of 12.5 mg once daily. Pediatric Patients with ITP Aged 1 to 5 Years: Initiate Eltrombopag at a dose of 25 mg once daily.
+
+
Chronic Hepatitis C-associated Thrombocytopenia-
+
+- Initiate Eltrombopag at a dose of 25 mg once daily. Monitoring and Dose Adjustment: Adjust the dose of Eltrombopag in 25-mg increments every 2 weeks as necessary to achieve the target platelet count required to initiate antiviral therapy. Monitor platelet counts every week prior to starting antiviral therapy. During antiviral therapy, adjust the dose of Eltrombopag to avoid dose reductions of Peginterferon. Monitor CBCs with differentials, including platelet counts, weekly during antiviral therapy until a stable platelet count is achieved. Monitor platelet counts monthly thereafter. Do not exceed a dose of 100 mg daily. Monitor clinical hematology and liver tests regularly throughout therapy with Eltrombopag.
+
+
Severe Aplastic Anemia-
+
+- Initiate Eltrombopag at a dose of 50 mg once daily. For patients with severe aplastic anemia of East Asian ancestry or those with mild, moderate or severe hepatic impairment (Child-Pugh Class A,B,C), initiate Eltrombopag at a reduced dose of 25 mg once daily.
+
",,"Take Eltrombopag at least 2 hours before or 4 hours after any medications or products containing polyvalent cations such as antacids, calcium-rich foods and mineral supplements.
","There are no contraindications for Eltrombopag
","The most common side effects of Eltrombopag in adults when used to treat chronic ITP are: In adult patients with ITP, the most common adverse reactions (greater than or equal to 5% and greater than placebo) were: nausea, diarrhea, upper respiratory tract infection, vomiting, increased ALT, myalgia and urinary tract infection. In pediatric patients age 1 year and older with ITP, the most common adverse reactions (greater than or equal to 10% and greater than placebo) were upper respiratory tract infection and nasopharyngitis.
In patients with chronic hepatitis C-associated thrombocytopenia, the most common adverse reactions (greater than or equal to 10% and greater than placebo) were: anemia, pyrexia, fatigue, headache, nausea, diarrhea, decreased appetite, influenza-like illness, asthenia, insomnia, cough, pruritus, chills, myalgia, alopecia and peripheral edema. In patients with severe aplastic anemia, the most common adverse reactions (greater than or equal to 20%) were: nausea, fatigue, cough, diarrhea and headache.
","Pregnancy Category C. There are no adequate and well controlled studies of Eltrombopag usein pregnancy. In animal reproduction and developmental toxicity studies, there was evidence ofembryolethality and reduced fetal weights at maternally toxic doses. Eltrombopag should beused in pregnancy only if the potential benefit to the mother justifies the potential risk to thefetus.
Nursing Mothers: It is not known whether Eltrombopag is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Eltrombopag, a decision should be made whether to discontinue nursing or to discontinue Eltrombopag taking into account the importance of Eltrombopag to the mother.
","Hepatotoxicity: Monitor liver function before and during therapy.
Thrombotic or Thromboembolic Complications: Portal vein thrombosis has been reported in patients with chronic liver disease receiving Eltrombopag. Monitor platelet counts regularly.
","Pediatric Use:The safety and efficacy of Eltrombopag in pediatric patients 1 year and older with chronic ITP were evaluated in two double-blind, placebo-controlled. The pharmacokinetics of Eltrombopag has been evaluated in 168 pediatric patients 1 year and older with ITP dosed once daily for dosing recommendations for pediatric patients 1 year and older. The safety and efficacy ofEltrombopag in pediatric patients younger than 1 year with ITP have not yet been established. The safety and efficacy of Eltrombopag in pediatric patients with thrombocytopenia associated with chronic hepatitis C and severe aplastic anemia have not been established.
Geriatric Use: Of the 106 patients in two randomized clinical trials of Eltrombopag 50 mg in chronic ITP, 22% were 65 years of age and over, while 9% were 75 years of age and over. In the two randomized clinical trials of Eltrombopag in patients with chronic hepatitis C and thrombocytopenia, 7% were 65 years of age and over, while fewer than 1% were 75 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger patients in the placebo-controlled trials, but greater sensitivity of some older individuals cannot be ruled out.
Hepatic Impairment: Hepatic impairment influences the exposure of Eltrombopag. Reduce the initial dose of Eltrombopag in patients with chronic ITP (adult and pediatric patients 6 years and older only) or severe aplastic anemia who also have hepatic impairment (Child-Pugh Class A, B, C). No dosage adjustment is necessary for patients with chronic hepatitis C and hepatic impairment.
Renal Impairment: No adjustment in the initial dose of Eltrombopag is needed for patients with renal impairment. Closely monitor patients with impaired renal function when administering Eltrombopag.
","In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications.
In one report, a subject who ingested 5,000 mg of Eltrombopag had a platelet count increase to a maximum of 929 x 109/L at 13 days following the ingestion. The patient also experienced rash, bradycardia, ALT/AST elevations and fatigue. The patient was treated with gastric lavage, oral Lactulose, Intravenous fluids, Omeprazole, Atropine, Furosemide, Calcium, Dexamethasone, andPlasmapheresis; however, the abnormal platelet count and liver test abnormalities persisted for 3 weeks. After 2 months follow-up, all events had resolved without sequelae.
In case of an overdose, consider oral administration of a metal cation-containing preparation, such as Calcium, Aluminum, or Magnesium preparations to chelate Eltrombopag and thus limit absorption. Closely monitor platelet counts. Reinitiate treatment with Eltrombopag in accordance with dosing and administration recommendations.
",,,"Store in a cool and dry place, away from light and moisture. Keep out of the reach of children.
",12
+1647,Elagolix,elagolix-1647,https://medex.com.bd/attachments/OqDsz6QBWxuVFKQ3MwDKnMbnfoQ481/elagolix-prescribing-information,Gonadotropin-releasing hormone (GnRH) antagonist,Endometriosis,"Elagolix is indicated for the management of moderate to severe pain associated with endometriosis.
","Gonadotropin-releasing hormone (GnRH) antagonist
","Endometriosis develops when tissue that is similar to the kind that is normally located in the uterus starts to grow outside of the uterus. Such growth leads to various symptoms like pain during periods, pelvic pain between periods, and pain during sexual intercourse. The growths themselves are referred to as lesions and frequently develop on the ovaries, fallopian tubes, and other areas around the uterus, including the bowel or bladder. The growth of these lesions is dependent upon the estrogen hormone.
Elagolix is an orally-administered, nonpeptide small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist that inhibits endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland Label. Administration of elagolix results in dose-dependent suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to decreased blood concentrations of the ovarian sex hormones, estradiol and progesterone.
","Exclude pregnancy before starting Elagolix or start Elagolix within 7 days from the onset of menses. Take Elagolix at approximately the same time each day, with or without food.
Initiate treatment with Elagolix 150 mg once daily-
+
+- Maximum Treatment Duration: 24 months
+- Coexisting Condition: None
+
+Consider initiating treatment with Elagolix 200 mg twice daily-
+
+- Maximum Treatment Duration: 6 months
+- Coexisting Condition: Dyspareunia
+
+Initiate treatment with Elagolix 150 mg once daily. Use of 200 mg twice daily is not recommended-
+
+- Maximum Treatment Duration: 6 months
+- Coexisting Condition: Moderate hepatic impairment (Child-Pugh Class B)
+
",,"May potentiate P-gp substrates (eg. Digoxin), CYP2C19 substrates (eg. Dose limit of Omeprazole is upto 40mg daily). May antagonize CYP3A substrates. Antagonizes oral Midazolam, Rosuvastatin; consider increasing their doses. Maybe antagonized by CYP3A inducers. Reduces efcacy with estrogen-containing contraceptives.
","Elagolix is contraindicated in women:
+
+- Who are pregnant
+- Exposure to ORILISSA early in pregnancy may increase the risk of early pregnancy loss.
+- With known osteoporosis because of the risk of further bone loss
+- With severe hepatic impairment because of the risk of bone loss
+- With concomitant use of strong organic anion transporting polypeptide (OATP) 1B1 inhibitors (e.g., cyclosporine and gemfibrozil)
+
","Most common adverse reactions (>5%) in clinical trials included hot flushes and night sweats, headache, nausea, insomnia, amenorrhea, anxiety, arthralgia, depression-related adverse reactions and mood changes.
","Exposure to Elagolix early in pregnancy may increase the risk of early pregnancy loss. Use of Elagolix is contraindicated in pregnant women. Discontinue Elagolix if pregnancy occurs during treatment. The limited human data with the use of Elagolix in pregnant women are insufficient to determine whether there is a risk for major birth defects or miscarriage. Although two cases of congenital malformations were reported in clinical trials with Elagolix, no pattern was identified and miscarriages were reported at a similar incidence across treatment groups. There is no information on the presence of elagolix or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production.
There are no adequate animal data on the excretion of Elagolix in milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Elagolix and any potential adverse effects on the breastfed child from Elagolix.
","
+- Bone Loss: Dose- and duration-dependent decreases in bone mineral density (BMD) that may not be completely reversible. Assess BMD in women with additional risk factors for bone loss
+- Reduced Ability to Recognize Pregnancy: Elagolix may alter menstrual bleeding, which may reduce the ability to recognize pregnancy. Perform testing if pregnancy is suspected. Discontinue if pregnancy is confirmed
+- Suicidal Ideation and Mood Disorders: Advise patients to seek medical attention for suicidal ideation, suicidal behavior, new onset or worsening depression, anxiety, or other mood changes
+- Hepatic Transaminase Elevations: Dose-dependent elevations in serum alanine aminotransferase (ALT). Counsel patients on signs and symptoms of liver injury
+- Potential for Reduced Efficacy with Estrogen-Containing Contraceptives: Use non-hormonal contraception during treatment and for one week after discontinuing Elagolix.
+
","
+- No dose adjustment of Elagolix is required in women with any degree of renal impairment or end-stage renal disease (including women on dialysis)
+- No dosage adjustment of Elagolix is required in women with mild hepatic impairment.
+- Safety and effectiveness of Elagolix in patients less than 18 years of age have not been established.
+
","In case of overdose, patients should be monitored for any signs or symptoms of adverse reactions and initiate appropriate symptomatic treatment, as needed.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+435,Estriol (Oral),estriol-oral-435,https://medex.com.bd/attachments/57M7FHwxXj7izbRQzh7DIw1cMdnzwy/estriol-oral-prescribing-information,Female Sex hormones,Vaginitis,"Estriol tablet is indicatd in-
+
+- Atrophy of the lower urogenital tract related to oestrogen deficiency, notably for the treatment of vaginal complaints such as dyspareunia, dryness and itching, for the prevention of recurrent infections of the vagina and lower urinary tract, in the management of micturition complaints (such as frequency and dysuria) and mild urinary incontinence.
... Read more
Estriol tablet is indicatd in-
+
+- Atrophy of the lower urogenital tract related to oestrogen deficiency, notably for the treatment of vaginal complaints such as dyspareunia, dryness and itching, for the prevention of recurrent infections of the vagina and lower urinary tract, in the management of micturition complaints (such as frequency and dysuria) and mild urinary incontinence.
+- Pre and postoperative therapy in postmenopausal women undergoing vaginal surgery
+- Climacteric complaints such as hot flushes and night sweating
+- A diagnostic aid in case of a doubtful atrophic cervical smear
+- Infertility due to cervical hostility.
+
","Drugs for Infertility, Drugs for menopausal symptoms: Hormone replacement therapy, Female Sex hormones
","Estriol induces the normalization of the vaginal epithelium and thus helps to restore the normal microflora and the physiological pH in the vagina. As a result, it increases the resistance of the vaginal epithelial cells to infection and inflammation. In comparison to other estrogens, estriol is short acting. In the years just before and after the menopause (which can be natural or surgically induced) estriol can be used in the treatment of symptoms and complaints related to estrogen deficiency. Estriol is particularly used in the treatment of urogenital symptoms.
After oral administration, estriol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma levels of unconjugated estriol are reached within 1 hr of administration. Nearly all (90%) estriol is bound to albumin in the plasma and unlike other estrogens; estriol is hardly bound to sex hormone-binding globulin. The metabolism of estriol consists mainly of conjugation and deconjugation during enterohepatic circulation. Estriol, a metabolic end product, is mainly excreted via the urine in the conjugated form. Only a small fraction is excreted via the feces, mainly as unconjugated estriol.
","It is important that the total daily dose is taken at one time. It may be taken with or without food.
+
+- Atropy of the lower urogenital tract: 4-8 mg/day for the first weeks, followed by a gradual reduction, based on relief of symptoms, until a maintenance dosage (e.g. 1-2 mg/day) is reached.
+- Pre and postoperative therapy in postmenopausal women undergoing vaginal surgery: 4-8 mg/day in the 2 weeks before surgery; 1-2 mg/day in the 2 weeks after surgery.
+- Climacteric complaints such as hot flushes and night sweating: 4-8 mg/day during the first weeks, followed by a gradual reduction. For maintenance therapy the lowest effective dosage should be used.
+- A diagnostic aid in case of a doubtful atrophic cervical smear: 2-4 mg/day for 7 days before taking the next smear.
+- Infertility due to cervical hostility: In general 1-2 mg/day on days 6-15 of the menstrual cycle. However, for some patients dosages as low as 1 mg/day are sufficient, whereas others may need up to 8 mg/day. Therefore, the dosage should be increased each month until an optimal effect on the cervical mucus is obtained.
+
",,"There are strong indications that estrogens, estriol included, can increase the pharmacologic effects of certain corticosteroids. If necessary, the dosage of the corticosteroid should be reduced. There are also some indications, mainly obtained with other estrogens or oral contraceptives, that concurrent use of estriol with activated charcoal, barbiturates, hydantoins and rifampicin may possibly decrease the effectiveness of estriol.
","Contraindicated in pregnancy, known or suspected estrogen-dependent tumours, undiagnosed vaginal bleeding, untreated endometrial hyperplasia, known or suspected breast cancer.
","Breast tension or pain, nausea, spotting, fluid retention and cervical hypersecretion may occasionally occur and be indicative of too high dosage. Headache, hypertension, leg cramps and vision disturbances are seldom observed. In general, most of these adverse reactions disappear after the 1 st week of treatment.
Breast enlargement, vaginal candidiasis, change in vaginal bleeding pattern, vomiting, stomach cramps, cholestatic jaundice, chloasma or melasma, erythema multiforme, erythema nodosum, hemorrhagic eruption, mental depression, chorea, increasing or decreasing body weight, edema, changes in libido.
","Estriol is contraindicated during pregnancy. Use Estriol in breastfeeding women only if really needed, as estriol is excreted in the milk and it may decrease the quality and quantity of the milk production.
","During prolonged treatment with estrogens, periodic medical examinations are advisable. With vaginal infections, a concomitant specific treatment is recommended. In order to prevent endometrial stimulation, the daily dose should not exceed 8 mg nor should this maximum dose be used for longer than several weeks. Patients with any of the following conditions should be monitored: A history of latent or overt cardiac failure, fluid retention due to renal dysfunction, hypertension, epilepsy or migraine (or a history of these conditions), severe liver disorders, endometriosis, fibrocystic mastopathy, porphyria, hyperlipoproteinaemia, a history during pregnancy or previous use of steroids of severe pruritus, cholestatic jaundice or herpes gestationis. Estrogen is reported to increase the risk of endometrial carcinoma in postmenopausal women. Use with precaution in gallbladder disorders, hypercalcemia, additional progestin, hypercoagulability, urethral bleeding and mastodynia.
",,"Symptoms that may occur in the case of an acute overdosage are nausea, vomiting and possibly withdrawal bleeding in females. No specific antidote is known. If necessary, a symptomatic treatment should be instituted.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+1832,Estradiol Valerate,estradiol-valerate-1832,https://medex.com.bd/attachments/QKTK7Kv8VsUTI8Xfi7aNGfV6Yebi6G/estradiol-valerate-prescribing-information,Female Sex hormones,Ovulation induction,"Estradiol Valerate is indicated for Hormone Replacement Therapy in:
+
+- Ovulation Induction
+- Intrauterine Insemination
+- In vitro fertilization
+
+Estradiol valerate is an estrogen medication. In women, it is used in hormone therapy for menopausal symptoms.
","Drugs for menopausal symptoms: Hormone replacement therapy, Female Sex hormones
",,"Ovulation Induction:
+
+- Estradiol valerate: 2 mg twice daily for 5 days (from 8th day to 12th day of cycle)
+- Letrozole: 2.5 mg twice daily for 5 days (from 3rd day till 7th day of cycle)
+- Duration: 3 cycles
+
+Intrauterine Insemination:
+
+- Estradiol Valerate: 6 or 8 mg daily in 3 or 4 divided doses (from 8th day till 12th day of cycle)
+- Duration: 3 cycles
+
+In vitro fertilization:
+
+- Estradiol Valerate: 6 mg in 3 divided doses daily. From 1st to 28th day of the cycle 600 mg progesterone in 3 divided doses daily from 14th to 28th day of the cycles
+- Duration: 8 weeks of the cycle
+
",,,"Substances increasing the clearance of sex hormones (diminished efficacy by enzyme-induction), e.g.: The metabolism of oestrogens may be increased by concomitant use of substances known to induce drug- metabolising enzymes, specifically cytochrome P450 enzymes, such as anticonvulsants (e.g. barbiturates, phenytoin, primidone, carbamazepine) and anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz) and possibly also felbamate, griseofulvin, oxcarbazepine, topiramate and products containing the herbal remedy St. John's Wort (Hypericum perforatum). Clinically, an increased metabolism of oestrogens and progestogens may lead to decreased effect and changes in the uterine bleeding profile. Enzyme induction can already be observed after a few days of treatment. Maximal enzyme induction is generally seen within a few weeks. After cessation of drug therapy enzyme induction may be sustained for about 4 weeks.
Substances decreasing the clearance of sex hormones (enzyme inhibitors): Strong and moderate CYP3A4 inhibitors such as azole antifungals (e.g. fluconazole, itraconazole, ketoconazole, voriconazole), verapamil, macrolides (e.g. clarithromycin, erythromycin), diltiazem and grapefruit juice can increase plasma concentrations of the oestrogen.
","The following diseases are reported more often in women using HRT compared to women not using HRT:
+
+- breast cancer
+- abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer)
+- ovarian cancer
+- blood clots in the veins of the legs or lungs (venous thromboembolism)
+- heart disease
+- stroke
+- probable memory loss if HRT is started over the age of 65 Other side effects that have been linked to the use of Estradiol Valerate and other oral hormone replacement therapies
+- During the first few months of treatment you may experience some vaginal bleeding at unexpected times (breakthrough bleeding and spotting). These symptoms normally lessen with continued treatment. If they don’t, contact your doctor (see section 2 HRT and cancer/Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)’ for more information)
+- breast pain, tenderness or enlargement, breast discharge
+- painful periods, changes in vaginal secretions, pre-menstrual symptoms, increased size of fibroids in the womb, thrush, changes to the neck of the womb
+- indigestion, a feeling of being bloated, passing wind, feeling or being sick, abdominal pain, gall bladder disease
+- skin rashes or discolouration, itching, eczema, acne, unusual hair loss or hair growth, increased skin pigment especially on the face (chloasma other conditions for more information), some rare skin problems
+- headache, migraine, dizziness, anxiety or depressive symptoms, fatigue
+- fast or irregular heartbeat (palpitations), high blood pressure, inflammation of veins usually in the legs
+- fluid retention leading to swelling of parts of the body
+- changes in body weight and sex drive, increased appetite
+- muscle cramps, leg pains
+- nose bleeds, visual disturbances (such as blurred vision), discomfort with contact lenses, allergic-type reactions, a worsening of glucose tolerance, bladder inflammation, rare disorders (porphyria, chorea).
+
",,"Conditions that need supervision: If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised. It should be taken into account that these conditions may recur or be aggravated during treatment with It, in particular:
+
+- Leiomyoma (uterine fibroids) or endometriosis
+- Risk factors for, thromboembolic disorders » Risk factors for oestrogen dependent tumours, e.g. 1st degree heredity for breast cancer
+- Hypertension
+- Liver disorders (e.g. liver adenoma)
+- Diabetes mellitus with or without vascular involvement
+- Cholelithiasis
+- Migraine or (severe) headache
+- Systemic lupus erythematosus
+- A history of endometrial hyperplasia
+- Epilepsy
+- Asthma
+- Otosclerosis
+- Hereditary angioedema.
+
+
If you forget to take Estradiol Valerate: If the woman forgets to take a tablet at the usual time, she may take it within the following 12 hours. If the woman is more than 12 hours late the forgotten tablet should not be taken and the remaining tablets taken at the usual time on the right days. A missed dose may lead to breakthrough bleeding or spotting.
",,,,,"Store below 30°C and dry place. Keep away from light. Keep out of the reach of children.
",7
+434,Estradiol,estradiol-434,https://medex.com.bd/attachments/nnZq96a25JTvAqbmMFZIbRWPjvp7km/estradiol-tablets-prescribing-information,Female Sex hormones,Vaginitis,"Short term treatment of climacteric complaints after the cessation of monthly bleeding, or deficiency symptoms after oophorectomy or radiological castration for non-carcinomatous diseases, such as hot flushes, outbreaks of sweat, sleep disturbances, depressive moods, irritability, headaches, dizziness ... Read more
Short term treatment of climacteric complaints after the cessation of monthly bleeding, or deficiency symptoms after oophorectomy or radiological castration for non-carcinomatous diseases, such as hot flushes, outbreaks of sweat, sleep disturbances, depressive moods, irritability, headaches, dizziness. Estradiol also has a favourable influence on bladder irritation (a not infrequent occurrence in the climacteric), signs of cutaneous and mucosal involution (particularly in the genital region) which normally occur with advancing age.
","Female Sex hormones
",,"Hormone therapy should only be continued as long as the benefit in alleviation of severe symptoms outweighs the risk. A complete medical history should be taken and a physical examination should be conducted prior to the initiation or reinstitution of HRT, should be repeated periodically. The frequency and nature of these examinations should be based on established practice guidelines, 6 monthly reviews are generally considered appropriate, and be adapted to the individual woman, but should generally include pelvic organs, including routine cervical cytology, abdomen, breasts and blood pressure. The need for continued therapy should be reconsidered at each review. Unless otherwise prescribed by the doctor, 1 tablet Estradiol is taken daily and the tablets are to be swallowed whole with some liquid. Each pack covers 30 days and treatment is continuous, which means that the next pack follows immediately without a break. It does not matter at what time of the day the patient takes her tablet, but once she has selected a particular time, she should keep it to every day. If she forgets to take a tablet at the usual time, she may take it within the following 12 to 24 hours. If the treatment is discontinued for longer, irregular bleeding may occur. Treatment may be started at any time provided that pregnancy has been excluded. High-dosed and long-term use of unopposed oestrogens during the climacteric may increase the incidence of endometrial carcinoma. Endometrial hyperplasia should be avoided in unopposed oestrogen treatment. It is therefore mandatory to add a progestogen for the last 10-14 days of each month of therapy. As a general rule, Estradiol treatment should be discontinued every 6 months in order to verify the persistence of complaints requiring treatment. It is essential to adhere to the dosage scheme prescribed by the doctor and to keep the appointments made for gynaecological check-ups.
",,"Interaction with laboratory tests: The use of sex steroids may influence biochemical parameters of, for example, liver, thyroid, adrenal and renal function, plasma levels of (carrier) proteins such as corticosteroid-binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism, and parameters of coagulation and fibrinolysis.
Interactions with other medicines: Long-term treatment with hepatic enzyme-inducing drugs (e.g. several anticonvulsants and antimicrobials) can increase the clearance of sex hormones and may reduce clinical efficacy. Such hepatic enzyme-inducing properties have been established for hydantoins, barbiturates, primidone, carbamazepine, and rifampicin and are also suspected for oxcarbazepine, topiramate, felbamate, griseofulvin and the herbal remedy St John’s Wort (hypericum perforatum). Maximal enzyme induction is generally not seen before 2-3 weeks but may be sustained for at least 4 weeks after cessation of drug therapy. In rare cases, reduced oestradiol levels have been observed under the simultaneous use of certain antibiotics (e.g. penicillins and tetracycline). Substances which undergo substantial conjugation (e.g. paracetamol) may increase the bioavailability of oestradiol by competitive inhibition of the conjugation system during absorption. In individual cases, the requirement for oral antidiabetics or insulin can change as a result of the effect on glucose tolerance.
","HRT should not be started in the presence of any of the conditions listed below. Should any of the following conditions appear during HRT use, the product should be stopped immediately. Pregnancy and Lactation, undiagnosed vaginal bleeding, known or suspected cancer of the breast, known or suspected premalignant conditions or malignancies, if sex steroid-influenced, presence or history of liver tumours (benign or malignant), severe hepatic disease, acute arterial thromboembolism (e.g. myocardial infarction, stroke), active deep vein thrombosis, thromboembolic disorders, or a documented history of these conditions, a high risk of venous or arterial thrombosis, severe hypertriglyceridemia, Idiopathic cholestatic jaundice of pregnancy or jaundice with prior combined oral contraceptive use or combined HRT use, Otosclerosis with deterioration during pregnancy, Severe diabetes with vascular changes known hypersensitivity to any of the components of Estradiol.
",,"Pregnancy category B3. Estradiol is contraindicated during pregnancy. If pregnancy occurs during medication with Estradiol, treatment must be discontinued immediately. In animal studies, maternal administration of high doses of synthetic oestrogens produced urogenital malformations in the offspring. However, the relevance of the animal findings for the clinical use of 17b-oestradiol is uncertain. Estradiol is contraindicated during lactation
","The benefits and risks of HRT must be carefully weighed, including consideration of the emergence of risks as therapy continues. estrogens with or without progestogens should be prescribed at the lowest effective doses and for the shortest duration consistent with the treatment goal and risks for the individual women. If any of the conditions/risk factors mentioned below is present or deteriorates, an individual risk-benefit analysis should be done before HRT is started or continued. The potential for an increased synergistic risk of thrombosis should be considered in women who possess a combination of risk factors or exhibit a greater severity of an individual risk factor. This increase risk may be greater than a simple cumulative risk of the factor. HRT should not be prescribed in case of a negative risk benefit assessment.
","Paediatric use: Estradiol is not indicated for use in children and adolescents.
Patients with hepatic impairment: Estradiol has not been studied in hepatic impaired patients. Estradiol is contraindicated in women with severe hepatic disease.
","Acute toxicity studies indicate that even in the case of inadvertent intake of a multiple of the therapeutic dose, no acute toxicity risk is to be expected. Overdose may cause nausea and vomiting and withdrawal bleeding may occur in some women. Management of acute overdose should be supportive.
",,,"Store in a cool (below 30°C) and dry place, away from light & children.
",10
+1462,Esomeprazole + Amoxicillin + Clarithromycin,esomeprazole-amoxicillin-clarithromycin-1462,https://medex.com.bd/attachments/LPAXYDsmf80xTM1sgpNd8BAoohinDy/esomeprazole-amoxicillin-clarithromycin-prescribing-information,Anti H. pylori drugs,H. pylori infection,"This combination is indicated for the eradication of H. pylori in active chronic gastric, duodenal and gastric ulcers.
","Anti H. pylori drugs
","Esomeprazole exerts its stomach acid-suppressing effects by preventing the final step in gastric acid production by covalently binding to sulfhydryl groups of cysteines found on the (H+, K+)-ATPase enzyme at the secretory surface of gastric parietal cells. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. As the binding of esomeprazole to the (H+, K+)-ATPase enzyme is irreversible and new enzyme needs to be expressed in order to resume acid secretion, esomeprazole's duration of antisecretory effect that persists longer than 24 hours
Amoxicillin is similar to penicillin in its bactericidal action against susceptible bacteria during the stage of active multiplication. It acts through the inhibition of cell wall biosynthesis that leads to the death of the bacteria.
Clarithromycin acts by inhibiting microsomal protein synthesis in susceptible organisms mainly by binding to the donor site on the 50S subunit of the bacterial ribosome and preventing translocation to that site.
","Each tablet twice daily for 7-14 days or as per the physician’s advice
",,"Esomeprazole is metabolized through the cytochrome P450 system, specially through the CYP3A isozymes. Studies have shown that Esomeprazole does not have clinically significant interactions with other drugs metabolized by the cytochrome P450 system, such as warfarin, antipyrine, indomethacin, ibuprofen, phenytoin, propranolol, prednisolone, diazepam, clarithromycin or terfenadine in healthy subject.
Clarithromycin use in patients who are receiving theophylline may be associated with an increase of serum theophylline concentrations.
There have been reports of interactions of clarithromycin with carbamazepine, cyclosporine, tactrolimus, hexobarbital, phenytoin, alfetanil, disopyramide, lovastatin, bromocriptine, valproate, terfenadine, cisapride, pimozide & astemizole.
","This is contraindicated in patients with known hypersensitivity to any of its component.
","H. pylori eradication therapy is generally well tolerated. Adverse events reported during clinical trials were not unexpected given the component substances. Common adverse reactions included diarrhoea and nausea.
","This should only be given to pregnant women if its use is considered essential. The safety of this combination for use during breast feeding of infants has not been established.
","Serious and occasionally fatal hypersensitivity reactions have been reported in patients on Amoxicillin therapy. These reactions are more apt to occur in indivduals with a history of penicillin hypersensitivity. Clarithromycin should not used in pregnant women except in clinical circumstances where no alternative is appropriate.
","GERIATRIC USE: Although this regimen has not been specifically studied in the elderly, dosage adjustment is not needed during therapy with individual components. It is therefore unlikely to require dosage adjustment with this combination
",,,,"Store in a cool (below 30 degree C) and dry place.
",11
+1669,Esomeprazole (MUPS tablet),esomeprazole-mups-tablet-1669,,,,"Esomeprazole MUPS tablet is indicated in:
+
+- Gastro-esophageal Reflux Disease (GERD).
+- Risk reduction in NSAID associated gastric ulcer.
+- H. pylori eradication (Triple therapy).
+- Zollinger-Ellison syndrome and idiopathic hypersecretion.
+
",,"Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+ ATPase in the gastric parietal cell. Esomeprazole (S-isomer of omeprazole) is the first single optical isomer of proton pump inhibitor, provides better acid control than racemic proton pump inhibitors.
","Erosive esophagitis-
+
+- Adult (≥18 years): 40 mg once daily for 4 weeks.
+- Children & adolescents (12-18 years): 40 mg once daily for 4 weeks.
+
+Maintenance of healing of erosive esophagitis-
+
+- Adult (≥18 years): 20 mg once daily.
+- Children & adolescents (12-18 years): 20 mg once daily.
+
+Risk reduction in NSAID associated gastric ulcer-
+
+- Adult (≥18 years): 20 mg once daily for 4-8 weeks.
+
+H. pylori eradication (Esomeprazole MUPS tablet with 1000 mg Amoxicillin and 500 mg Clarithromycin)-
+
+- Adult (≥18 years): 20 mg twice daily for 7 days.
+- Children & adolescents (12-18 years): 20 mg twice daily for 7 days.
+
+Zollinger-Ellison syndrome and idiopathic hypersecretion-
+
+- Adult (≥18 years): 40-80 mg twice daily.
+
+
Children 1-11 years:
+
+- Erosive esophagitis: Weight <20 kg: 10 mg once daily for 8 weeks. Weight ≥20 kg: 10 mg or 20 mg once daily for 8 weeks
+- Maintenance of healing of erosive esophagitis: 10 mg once daily
+
+Children below the age of 1 year: Esomeprazole MUPS tablet is not approved for use in children younger than 1 year.
","Esomeprazole MUPS tablets should be swallowed whole with liquid. The tablets should not be chewed or crushed. If required, the tablets can also be dispersed in half a glass of non-carbonated water (mineral water is not suitable). No other liquids should be used. Stir until the tablets disintegrate and drink the liquid with the pellets immediately or within 30 minutes. Rinse the glass with half a glass of water and drink. The pellets must not be chewed or crushed.
","Esomeprazole is extensively metabolized in the liver by CYP2C19 and CYP3A4. In vitro and in vivo studies have shown that Esomeprazole is not likely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1 and 3A4. No clinically relevant interactions with drugs metabolized by these CYP enzymes would be expected. Drug interaction studies have shown that Esomeprazole does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin.
Esomeprazole may potentially interfere with CYP2C19, the major Esomeprazole metabolizing enzyme. Co-administration of Esomeprazole 30 mg anddiazepam, a CYP2C19 substrate has resulted in a 45% decrease in clearance of diazepam. Increased plasma levels of diazepam have been observed 12 hours after dosing and onwards. Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin).
Co-administration of oral contraceptives, diazepam, phenytoin, or quinidine do not seem to change the pharmacokinetic profile of Esomeprazole.
Combination Therapy with Clarithromycin: Co-administration of esomeprazole, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of esomeprazole and 14-hydroxyclarithromycin.
","Esomeprazole is contraindicated in patient with known hypersensitivity to any of the formulation.
","The most frequently occurring adverse events reported with Esomeprazole include headache, diarrhoea, nausea, flatulence, abdominal pain, constipation and dry mouth. There are no difference in types of related adverse events seen during maintenance treatment upto 12 months compared to short term treatment.
","The manufacturer advises caution. It is not known if Esomeprazole or its metabolites appear in human breast milk.
","Esomeprazole should be used carefully if the patient has severe liver dysfunction and severe renal impairment. Taking a proton pump inhibitor like Esomeprazole may slightly increase the risk of hip, wrist and spine fracture, particularly when it is taken over a period of more than one year.
",,,,,"Store in a cool & dry place below 25ºC, protect from light. Keep out of reach of children.
",10
+1674,Esmolol Hydrochloride,esmolol-hydrochloride-1674,https://medex.com.bd/attachments/YbAjcDwX7yzVJCY1A8ikcfXjv1FUKr/esmolol-hydrochloride-prescribing-information,Anti adrenergic agent (Beta blockers),Tachycardia,"Esmolol Hydrochloride is a beta adrenergic blocker indicated for the short-term
treatment of:
+
+- Control of ventricular rate in supraventricular tachycardia including atrial fibrillation and atrial flutter and control of heart rate in noncompensatory sinus tachycardia.
+- Control of perioperative tachycardia and hypertension.
+
","Anti adrenergic agent (Beta blockers)
","Esmolol Hydrochloride is a beta-1 selective (cardioselective) adrenergic receptor blocking agent with rapid onset, a very short duration of action, and no significant intrinsic sympathomimetic or membrane stabilizing activity at therapeutic dosages. Its elimination half-life after intravenous infusion is approximately 9 minutes. Esmolol Hydrochloride inhibits the beta 1 receptors located chiefly in cardiac muscle, but this preferential effect is not absolute and at higher doses it begins to inhibit beta 2 receptors located chiefly in the bronchial and vascular musculature.
","Administer intravenously. Titrate using ventricular rate or blood pressure at ≥4 minute intervals. Supraventricular tachycardia (SVT) or noncompensatory sinus tachycardia-
+
+- Optional loading dose: 500 mcg per kg infused over one minute
+- Then 50 mcg per kg per minute for the next 4 minutes
+- Adjust dose as needed to a maximum of 200 mcg per kg per minute
+- Additional loading doses may be administered
+
+Perioperative tachycardia and hypertension-
+
+- Loading dose: 500 mcg per kg over 1 minute for gradual control (1 mg per kg over 30 seconds for immediate control).
+- Than 50 mcg per kg per minute for gradual control (150 mcg per kg per minute for immediate control) adjusted to a maximum of 200 (tachycardia) or 300 (hypertension) mcg per kg per minute.
+
",,"
+- Digitalis glycosides: Risk of bradycardia
+- Anticholinesterases: Prolongs neuromuscular blockade
+- Antihypertensive agents: Risk of rebound hypertension
+- Sympathomimetic drugs: Dose adjustment needed
+- Vasoconstrictive and positive inotropic effect substances: Avoid concomitant use
+
","
+- Severe sinus bradycardia
+- Heart block greater than first degree
+- Sick sinus syndrome
+- Decompensated heart failure
+- Cardiogenic shock
+- Coadministration of IV cardiodepressant calcium-channel antagonists (e.g. verapamil) in close proximity to Esmolol hydrochloride
+- Pulmonary hypertension
+- Known hypersensitivity to esmolol
+
","Most common adverse reactions (incidence> 10%) are symptomatic hypotension (hyperhidrosis, dizziness) and asymptomatic hypotension.
","Pregnancy Category C. Esmolol hydrochloride has been shown to produce increased fetal resorptions with minimal maternal toxicity in rabbits when given in doses approximately 8 times the maximum human maintenance dose (300 mcg/kg/min). There are no adequate and well-controlled studies in pregnant women. Esmolol Hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Esmolol Hydrochloride, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","
+- Risk of hypotension, bradycardia, and cardiac failure: Reduce or discontinue use
+- Risk of exacerbating reactive airway disease
+- Diabetes mellitus: Increases the effect of hypoglycemic agents and masks hypoglycemic tachycardia
+- Risk of unopposed alpha-agonism and severe hypertension in untreated pheochromocytoma
+- Risk of myocardial ischemia when abruptly discontinued in patients with coronary artery disease
+
","Pediatric Use: The safety and effectiveness of Esmolol Hydrochloride in pediatric patients have not been established.
Geriatric Use: Clinical studies of Esmolol Hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects.
Hepatic Impairment: No special precautions are necessary in patients with hepatic impairment because Esmolol Hydrochloride is metabolized by red-blood cell esterases.
Renal Impairment: No dosage adjustment is required for esmolol in patients with renal impairment receiving a maintenance infusion of esmolol 150 mcg/kg for 4 hours.
",,,,"Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+433,Esomeprazole,esomeprazole-433,https://medex.com.bd/attachments/6DiDqjfz4lTajk26wePfh9XI6gE6ke/esomeprazole-tablets-granules-prescribing-information,,,"Esomeprazole is indicated:
+
+- To relieve from chronic heartburn symptoms and other symptoms associated with GERD
+- For the healing of erosive esophagitis
+- For maintenance of healing of erosive esophagitis
+- In combination with amoxicillin and clarithromycin for eradication of Helicobacter pylori infection in patients with duodenal ulcer disease.
... Read more
Esomeprazole is indicated:
+
+- To relieve from chronic heartburn symptoms and other symptoms associated with GERD
+- For the healing of erosive esophagitis
+- For maintenance of healing of erosive esophagitis
+- In combination with amoxicillin and clarithromycin for eradication of Helicobacter pylori infection in patients with duodenal ulcer disease.
+- Zollinger-Ellison Syndrome
+- Acid related Dyspepsia
+- Duodenal & Gastric ulcer
+
",,"Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. Esomeprazole (S-isomer of omeprazole) is the first single optical isomer of proton pump inhibitor, provides better acid control than racemic proton pump inhibitors.
Absorption: Esomeprazole capsules contain an enteric-coated pellet formulation of esomeprazole magnesium. After oral administration peak plasma levels (Cmax) occur at approximately 1.5 hours (Tmax). The Cmax increases proportionally when the dose is increased, and there is a three-fold increase in the area under the plasma concentration-time curve (AUC) from 20 to 40 mg. At repeated once daily dosing, the systemic bioavailability is approximately 90% compared to 64% after a single dose. The AUC after administration of a single dose of esomeprazole is decreased by 33-53% after food intake compared to fasting conditions. Esomeprazole should be taken at least one hour before meals.
Distribution: Esomeprazole is 97% bound to plasma proteins. Plasma protein binding is constant over the concentration range of 2 20 mmol/L. The apparent volume of distribution at steady state in healthy volunteers is approximately 16 L.
Metabolism: Esomeprazole is extensively metabolized in the liver by the cytochrome P450 (CYP) enzyme system. The metabolites of esomeprazole lack anti-secretory activity. The major part of esomeprazole’s metabolism is dependent upon the CYP2C19 isoenzyme, which forms the hydroxy and desmethyl metabolites. The remaining amount is dependent on CYP3A4 which forms the sulphone metabolite.
Excretion: The plasma elimination half-life of esomeprazole is approximately 1–1.5 hours. Less than 1% of parent drug is excreted in the urine. Approximately 80% of an oral dose of esomeprazole is excreted as inactive metabolites in the urine, and the remainder is found as inactive metabolites in the faeces.
Combination Therapy with Antimicrobials: Esomeprazole magnesium 40 mg once daily is given in combination with clarithromycin 500 mg twice daily and amoxicillin 1000 mg twice daily for 7 days. The mean steady state AUC and Cmax of Esomeprazole increased by 70% and 18%, respectively, during triple combination therapy compared to treatment with Esomeprazole alone. The pharmacokinetic parameters for clarithromycin and amoxicillin are similar during triple combination therapy and administration of each drug alone. However, the mean AUC and Cmax for 14-hydroxyclarithromycin are increased by 19% and 22%, respectively, during triple combination therapy compared to treatment with clarithromycin alone. This increase in exposure to 14-hydroxyclarithromycin is not considered to be clinically significant.
","Healing of Erosive Esophagitis: 20 mg or 40 mg Once Daily for 4-8 Weeks. The majority of patients are healed within 4 to 8 weeks. For patients who don't heal after 4-8 weeks, an additional 4-8 weeks of treatment may be considered. Maintenance of Healing of Erosive
Esophagitis: 20 mg Once Daily (Clinical studies did not extend 6 months).
Symptomatic GERD: 20 mg Once Daily for 4 Weeks. If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.
Helicobacter Pylori eradication: Triple Therapy to reduce the risk of Duodenal Ulcer recurrence-Esomeprazole 40 mg Once Daily for 10 days, Amoxicillin 1000 mg Twice Daily for 10 days, Clarithromycin 500 mg Twice Daily for 10 days.
Zollinger-Ellison Syndrome: The dose is 20-80 mg once daily. The dosage should be adjusted individually and treatment continued as long as clinically indicated.
Acid-related Dyspepsia: 20-40 mg once daily for 2-4 weeks according to the response.
Duodenal ulcer: 20 mg once daily for 2-4 weeks. Gastric ulcer: 20-40 mg once daily for 4-8 weeks.
Injection: The recommended adult dose is 40 mg Esomeprazole given once daily by intravenous injection (not less than 3 minutes) or intravenous infusion (10 to 30 minutes). Esomeprazole IV injection should not be administered concomitantly with any other medications through the same intravenous site. Treatment with Esomeprazole IV injection should be discontinued as soon as the patient is able to resume treatment with Esomeprazole delayed-release capsules. Safety and effectiveness in paediatric patients have not been established.
","Esomeprazole tablet or capsule: should be swallowed whole and taken one hour before a meal.
Direction for use of Delayed-Release Oral Suspension: Whole contents of the packet should be taken into a small glass containing 15 ml. of water. The mixer should be stirred well and leave 2 to 3 minutes to thicken. Stir again and drink within 30 minutes. If any medicine remains after drinking, add more water, stir, and drink immediately. If the suspension is to be administered through a nasogastric or gastric tube, the volume of water in the syringe should be 15 ml. & immediately shake the syringe and leave 2 to 3 minutes to thicken. Shake the syringe and inject it through the nasogastric or gastric tube into the stomach within 30 minutes. An appropriately sized syringe should be used. Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.
Esomeprazole IV Injection: Esomeprazole IV should be given as a slow intravenous injection. The solution for IV injection is obtained by adding to the vial 5 ml of the solvent (WFI) provided. After reconstitution, the injection should be given slowly over a period of at least 3 minutes. The solution should be used within 12 hours of reconstitution when stored at room temperature up to 30°C. No refrigeration is required. The reconstituted solution should not be used if it contains visible particulate.
","Esomeprazole is extensively metabolized in the liver by CYP2C19 and CYP3A4. In vitro and in vivo studies have shown that Esomeprazole is not likely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1 and 3A4. No clinically relevant interactions with drugs metabolized by these CYP enzymes would be expected. Drug interaction studies have shown that Esomeprazole does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin.
Esomeprazole may potentially interfere with CYP2C19, the major Esomeprazole metabolizing enzyme. Co-administration of Esomeprazole 30 mg and diazepam, a CYP2C19 substrate has resulted in a 45% decrease in clearance of diazepam. Increased plasma levels of diazepam have been observed 12 hours after dosing and onwards. Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin).
Co-administration of oral contraceptives, diazepam, phenytoin, or quinidine do not seem to change the pharmacokinetic profile of Esomeprazole.
Combination Therapy with Clarithromycin: Co-administration of esomeprazole, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of esomeprazole and 14-hydroxyclarithromycin.
","Esomeprazole is contraindicated in-patient with known hypersensitivity to any of the formulation.
","The most frequently occurring adverse events reported with Esomeprazole include headache, diarrhoea, nausea, flatulence, abdominal pain, constipation and dry mouth. There are no difference in types of related adverse events seen during maintenance treatment upto 12 months compared to short term treatment.
","There are no adequate and well-controlled studies in pregnant women. Animal studies have revealed no teratogenic effects. The excretion of esomeprazole in milk has not been studied. Breast-feeding should be therefore be discontinued if the use of esomeprazole is considered essential.
","General: Symptomatic response to therapy with esomeprazole does not preclude the presence of gastric malignancy.
Information for patients: Esomeprazole capsules should be taken at least one hour before meals. For patients who have difficulty swallowing capsules, one tablespoon of applesauce can be added to an empty bowl and the Esomeprazole capsules can be opened, and the pellets inside the capsule carefully emptied onto the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellet/applesauce mixture should not be stored for future use. Antacids may be used while taking esomeprazole.
","Paediatric Use: Safety and effectiveness in paediatric patients have not been established.
Geriatric Use: No overall differences in safety and efficacy have been observed between the elderly and younger individuals, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out
Hepatic Insufficiency: No dosage adjustment is recommended for patients with mild to moderate hepatic insufficiency. However, in patients with severe hepatic insufficiency, a dose of 20 mg once daily should not be exceeded.
Renal Insufficiency: The Pharmacokinetics of Esomeprazole in patients with renal impairment are not expected to be altered relative to healthy volunteers as less than 1% of Esomeprazole is excreted unchanged in the urine.
","A single oral dose of Esomeprazole at 510 mg/kg (about 103 times the human dose on a body surface area basis), has been lethal to rats. The major signs of acute toxicity are reduced motor activity, changes in respiratory frequency, tremor, ataxia, and intermittent clonic convulsions. There have been no reports of overdose with Esomeprazole. No specific antidote for Esomeprazole is known. Since Esomeprazole is extensively protein bound, it is not expected to be removed by dialysis. In the event of overdosage, treatment should be symptomatic and supportive. As with the management of any overdose, the possibility of multiple drug ingestion should be considered.
",,"Infusion: Reconstitute one sterile single-dose vial of Esomeprazole IV Injection with 5 ml of the solvent (WFI) provided and further diluting the resulting solution within 0.9% Sodium Chloride solution or 5% Dextrose solution to make a final volume of 50 ml. The resultant infusion should be given intravenously over a period of 10-30 minutes. Chemical and physical in-use stability has been demonstrated for 12 hours after reconstitution with 0.9% Sodium Chloride solution or for 6 hours after reconstitution with 5% Dextrose solution. From a microbial point of view, the product should be used immediately. Any unused portion should be discarded.
","Store at a temperature not exceeding 30°C in a dry place. Protect from light and moisture. Keep out of reach of children.
",13
+431,Eslicarbazepine Acetate,eslicarbazepine-acetate-431,https://medex.com.bd/attachments/c1TijHnwAvU6yNgGcefjrU4UIbY8IJ/eslicarbazepine-acetate-prescribing-information,Adjunct anti-epileptic drugs,Partial seizures,"Eslicarbazepine acetate is indicated as an add-on therapy for partial seizure with or without secondary generalization.
","Adjunct anti-epileptic drugs
","Eslicarbazepine acetate is converted into the anti-epileptic medicine Eslicarbazepine in the body. Epilepsy is caused by excessive electrical activity in the brain. For electrical impulses to travel along nerves there needs to be a rapid movement of sodium into the nerve cells. Eslicarbazepine acetate is thought to work by blocking ‘voltage-gated sodium channels’, which stops sodium entering the nerve cells. This reduces the activity of the nerve cells in the brain, reducing the intensity and the number of seizures.
","Adult: Eslicarbazepine acetate must be added to existing anticonvulsant therapy. The recommended starting dose is 400 mg once daily which should be increased to 800 mg once daily after one or two weeks. Based on individual response the dose may be increased to 1200 mg once daily
Elderly (over 65 years of age): Caution should be exercised in the treatment of elderly patients as there is limited safety information on the use of Eslicarbazepine acetate in these patients.
Paediatric: The safety and efficacy of Eslicarbazepine acetate below 18 years has not yet been established. No data are available
",,"Carbamazepine: Based on individual response, the dose of Eslicarbazepine acetate may need to be increased if used concomitantly with carbamazepine.
Phenytoin: The dose of Eslicarbazepine acetate may need to be increased and the dose of phenytoin may need to be decreased.
Oral contraceptives: Administration of Eslicarbazepine acetate 1,200 mg once daily to female subjects using a combined oral contraceptive showed an average decrease of 37% and 42% in systemic exposure to levonorgestrel and ethinyloestradiol, respectively. Therefore, women of childbearing potential must use adequate contraception during treatment with Eslicarbazepine acetate.
Simvastatin: The dose of Simvastatin shall be increased if used with Eslicarbazepine.
","Hypersensitivity to the active substance, to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine) or to any of the excipients.
","The use of Eslicarbazepine acetate is associated with increase in the PR interval. Adverse reactions associated with PR interval prolongation (e.g. AV block, syncope, bradycardia) may occur.
","There are no data from the use of Eslicarbazepine acetate in pregnant women. Studies in animals have shown reproductive toxicity. If women receiving Eslicarbazepine acetate become pregnant or plan to become pregnant, the use of Exalief should be carefully re-evaluated.
It is unknown whether Eslicarbazepine acetate is excreted in human breast milk.
","Eslicarbazepine acetate has been associated with some central nervous system adverse reactions, such as dizziness and somnolence, which could increase the occurrence of accidental injury.
Eslicarbazepine acetate may decrease the effectiveness of hormonal contraceptives. Additional non-hormonal forms of contraception are recommended when using Eslicarbazepine acetate.
As with other anti-epileptic medicinal products, if Eslicarbazepine acetate is to be discontinued it is recommended to withdraw it gradually to minimize the potential of increased seizure frequency.
Concomitant use of Eslicarbazepine acetate with oxcarbazepine is not recommended because this may cause overexposure to the active metabolites.
Rash developed as an adverse reaction in 1.1% of total population treated with Eslicarbazepine acetate in placebo-controlled add-on studies in epileptic patients. If signs or symptoms of hypersensitivity develop, Eslicarbazepine acetate must be discontinued. Hyponatraemia has been reported as an adverse reaction in less than 1% of patients treated with Eslicarbazepine acetate.
","Patients with renal impairment: Caution should be exercised in the treatment of patients with renal impairment and the dose should be adjusted according to creatinine clearance (CLCR) as follows:
+
+- CLCR >60 ml/min: no dose adjustment required
+- CLCR 30-60 ml/min: initial dose of 400 mg every other day for 2 weeks followed by a once daily dose of 400 mg.
+- CLCR <30 ml/min: use is not recommended in patients with severe renal impairment due to insufficient data
+
+
Patients with hepatic impairment: No dose adjustment is needed in patients with mild to moderate hepatic impairment. The pharmacokinetics of Eslicarbazepine acetate has not been evaluated in patients with severe hepatic impairment and use in these patients is therefore not recommended.
",,,,"Store in a cool and dry place, protected from light and moisture. Keep the medicine out of the reach of children.
",11
+430,Escitalopram Oxalate,escitalopram-oxalate-430,https://medex.com.bd/attachments/nm2eRZYV1EBkVwWNj0AK7I6V83YPvz/escitalopram-oxalate-tablets-prescribing-information,SSRIs & related anti-depressant drugs,Trichotillomania,"Escitalopram Oxalate is indicated in the-
+
+- Treatment of major depressive episodes.
+- Treatment of panic disorder with or without agoraphobia.
+- Treatment of social anxiety disorder (social phobia).
+- Treatment of generalised anxiety disorder.
+- Treatment of obsessive-compulsive disorder.
+
","SSRIs & related anti-depressant drugs
","Escitalopram is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer of the racemic bicyclic phthalate derivative citalopram. Escitalopram is at least 100 fold more potent than the R-enantiomer with respect to inhibition of 5-HT reuptake. Escitalopram has no or very low affinity for serotonergic or other receptors including alpha- and beta-adrenergic Dopamine, Histamine, Muscarinic and benzodiazepine receptors.
","Safety of daily doses above 20 mg has not been demonstrated. Escitalopram Oxalate is administered as a single daily dose and may be taken with or without food.
Major depressive episodes: Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. Usually, 2-4 weeks are necessary to obtain an antidepressant response. After the symptoms resolve, treatment for at least 6 months is required for consolidation of the response.
Panic disorder with or without agoraphobia: An initial dose of 5 mg is recommended for the first week before increasing the dose to 10 mg daily. The dose may be further increased, up to a maximum of 20 mg daily, dependent on individual patient response. Maximum effectiveness is reached after about 3 months. The treatment lasts several months.
Social anxiety disorder: Usual dosage is 10 mg once daily. Usually, 2-4 weeks are necessary to obtain symptom relief. The dose may subsequently, depending on individual patient response, be decreased to 5 mg or increased to a maximum of 20 mg daily. Social anxiety disorder is a disease with a chronic course, and treatment for 12 weeks is recommended to consolidate response. Long-term treatment of responders has been studied for 6 months and can be considered on an individual basis to prevent relapse; treatment benefits should be re-evaluated at regular intervals. Social anxiety disorder is a well-defined diagnostic terminology of a specific disorder, which should not be confounded with excessive shyness. Pharmacotherapy is only indicated if the disorder interferes significantly with professional and social activities. The place of this treatment compared to cognitive behavioural therapy has not been assessed. Pharmacotherapy is part of an overall therapeutic strategy.
Generalised anxiety disorder: Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily. Long term treatment of responders has been studied for at least 6 months in patients receiving 20 mg/day. Treatment benefits and dose should be re-evaluated at regular intervals.
Obsessive-Compulsive Disorder: Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily. As OCD is a chronic disease, patients should be treated for a sufficient period to ensure that they are symptom-free. Treatment benefits and dose should be re-evaluated at regular intervals.
","Escitalopram should generally be administered once daily, morning or evening with or without food.
","As SSRI or related antidepressants should not be started until 2 weeks after stopping an MAOI. Conversely, an MAOI should not. be started until at least a week after an SSRI or related antidepressant has been stopped (2 weeks in the case of paroxetine and sertraline, at least 5 weeks in the case of fluoxetine).
","Escitalopram is contraindicated in patients with known hypersensitivity to Escitalopram or Citalopram or any of the inactive ingredients of the drug product. Concomitant use of escitalopram in patients taking monoamine oxidase/pimozide is contraindicated.
","SSRIs are less sedating and have fewer antimuscarinic and cardiotoxic effects than tricyclic antidepressants. Side-effects of the SSRIs include gastrointestinal effects (dose-related and fairly common include nausea, vomiting, dyspepsia, abdominal pain, diarrhoea, constipation), anorexia with weight loss (increased appetite and weight gain also reported) and hypersensitivity reactions including rash, urticaria, angioedema, anaphylaxis, arthralgia, myalgia, and photosensitivity; other side-effects include dry mouth, nervousness, anxiety, headache, insomnia, tremor, dizziness, asthenia, hallucinations, drowsiness, convulsions, galactorrhoea, sexual dysfunction, urinary retention, sweating, hypomania or mania, movement disorders and dyskinesias, visual disturbances.
","When treating a pregnant woman with Escitalopram during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. It is excreted in human breast milk. The decision whether to continue or discontinue either nursing or Escitalopram therapy should take into account the risk of citalopram exposure for the infant and the benefits Escitalopram treatment for the mother.
","SSRIs should be used with caution in patients with epilepsy (avoid if poorly controlled, discontinue if convulsions develop), concurrent electroconvulsive therapy (prolonged seizures reported with fluoxetine), history of mania, cardiac disease, diabetes mellitus, angle-closure glaucoma, concomitant use of drugs that increase risk of bleeding, history of bleeding disorders (especially gastro-lntestinal bleeding), hepatic and renal impairment.
","Elderly patients (>65 years of age): Initial dosage is 5 mg once daily. Depending on the individual patient response the dose may be increased to 10 mg daily. The efficacy of escitalopram in social anxiety disorder has not been studied in elderly patients.
Children and adolescents (<18 years): Escitalopram Oxalate should not be used in the treatment of children and adolescents under the age of 18 years.
Reduced renal function: Dosage adjustment is not necessary in patients with mild or moderate renal impairment. Caution is advised in patients with severely reduced renal function (CLCR less than 30 ml/min).
Reduced hepatic function: An initial dose of 5 mg daily for the first two weeks of treatment is recommended in patients with mild or moderate hepatic impairment. Depending on individual patient response, the dose may be increased to 10 mg daily. Caution and extra careful dose titration is advised in patients with severely reduced hepatic function.
Poor metabolizers of CYP2C19: For patients who are known to be poor metabolisers with respect to CYP2C19, an initial dose of 5 mg daily during the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased to 10 mg daily. Discontinuation symptoms seen when stopping treatment. Abrupt discontinuation should be avoided.
When stopping treatment with escitalopram the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of discontinuation symptoms. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.
","Symptoms: Symptoms seen in a reported overdose of escitalopram include symptoms mainly related to the central nervous system (ranging from dizziness, tremor, and agitation to rare cases of serotonin syndrome, convulsion, and coma), the gastrointestinal system (nausea/vomiting), and the cardiovascular system (hypotension, tachycardia, QT interval, prolongation, and arrhythmia) and electrolyte/fluid balance conditions (hypokalaemia, hyponatremia).
Management: There is no specific antidote. Establish and maintain an airway, ensure adequate oxygenation and respiratory function. Gastric lavage and the use of activated charcoal should be considered. Gastric lavage should be carried out as soon as possible after oral ingestion. Cardiac and vital signs monitoring are recommended along with general symptomatic supportive measures. ECG monitoring is advised in case of overdose, in patients with congestive heart failure/bradyarrhythmias, in patients using concomitant medications that prolong the QT-interval, or in patients with altered metabolism, e.g. liver impairment.
",,,"Store below 30°C temperature and protect from light & moisture. Keep the medicine out of the reach of children.
",13
+422,Erythropoietin Alfa,erythropoietin-alfa-422,https://medex.com.bd/attachments/rDLM3Onmwf5z9ljpEgnJziarl9WfKj/erythropoietin-alfa-prescribing-information,Drugs for Haemolytic Hypoplastic & Renal Anemia,To reduce the need for allogenic blood tranfusion,"Erythropoietin alfa is an erythropoiesis-stimulating agent (ESA) indicated for:
Treatment of anemia due to:
+
+- Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis.
+- Zidovudine in HIV-infected patients.
+- The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
... Read more
Erythropoietin alfa is an erythropoiesis-stimulating agent (ESA) indicated for:
Treatment of anemia due to:
+
+- Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis.
+- Zidovudine in HIV-infected patients.
+- The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
+
+Reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery.
Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 gm and gestational age of less than 34 weeks.
","Drugs for Haemolytic Hypoplastic & Renal Anemia
",,"Evaluation of Iron Stores and Nutritional Factors: Evaluate the iron status in all patients before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating Erythropoietin alfa.
For all patients with CKD: When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
+
+- Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Avoid frequent dose adjustments.
+- If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Erythropoietin alfa by 25% or more as needed to reduce rapid responses.
+- For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.
+- For patients who do not respond adequately over a 12-week escalation period, increasing the Erythropoietin alfa dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue Erythropoietin alfa if responsiveness does not improve.
+
+
For patients with CKD on dialysis:
+
+- Initiate Erythropoietin alfa treatment when the hemoglobin level is less than 10 g/dL.
+- If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Erythropoietin alfa.
+- The recommended starting dose for adult patients is 50 to 100 units/kg3 times weekly intravenously or subcutaneously. For pediatric patients, a starting dose of 50 units/kg3 times weekly intravenously or subcutaneously is recommended. The intravenous route is recommended for patients on hemodialysis.
+
+
For patients with CKD not on dialysis: Consider initiating Erythropoietin alfa treatment only when the hemoglobin level is less than 10 g/dL and the following considerations apply:
+
+- The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and,
+- Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal.
+- If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of Erythropoietin alfa, and use the lowest dose of Erythropoietin alfa sufficient to reduce the need for RBC transfusions.
+- The recommended starting dose for adult patients is 50 to 100 units/kg 3 times weekly intravenously or subcutaneously.
+
+
Zidovudine-treated HIV-infected Patients: Starting Dose: The recommended starting dose in adults is 100 units/kg as an intravenous or subcutaneous injection 3 times per week.
Dose Adjustment-
+
+- If hemoglobin does not increase after 8 weeks of therapy, increase Erythropoietin alfa dose by approximately 50 to 100 units/kg at 4- to 8-week intervals until hemoglobin reaches a level needed to avoid RBC transfusions or 300 units/kg.
+- Withhold Erythropoietin alfa if hemoglobin exceeds 12 g/dL. Resume therapy at a dose 25% below the previous dose when hemoglobin declines to less than 11 g/dL.
+- Discontinue Erythropoietin alfa if an increase in hemoglobin is not achieved at a dose of 300 units/kg for 8 weeks.
+
+
Patients on Cancer Chemotherapy: Initiate Erythropoietin alfa in patients on cancer chemotherapy only if the hemoglobin is less than 10 g/dL, and if there is a minimum of two additional months of planned chemotherapy. Use the lowest dose of Erythropoietin alfa necessary to avoid RBC transfusions.
+
+- Adults: 150 units/kg subcutaneously 3 times per week until completion of a chemotherapy course or 40,000 units subcutaneously weekly until completion of a chemotherapy course.
+- Pediatric Patients (5 to 18 years): 600 units/kg intravenously weekly until completion of a chemotherapy course.
+- Prevention of anemia of prematurity: Erythropoietin alfa is administered subcutaneously at a dose of 3x250 IU/kg b.w. per week. Treatment should start as early as possible, preferably by day 3 of life. Premature infants who have received a transfusion before starting Erythropoietin alfa treatment are not likely to benefit as much as infants who have not had a transfusion. The treatment should last for 6 weeks.
+
","Preparation and Administration-
+
+- Do not shake. Do not use Erythropoietin alfa that has been shaken or frozen.
+- Protect syringe from light.
+- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use any syringe exhibiting particulate matter or discoloration.
+- Discard unused portions of Erythropoietin alfa.
+
","There are no known clinically significant drug interactions but the effect of Erythropoietin alfa may be potentiated by the simultaneous therapeutic administration of a haematinic agent such as ferrous sulphate when a deficiency state exists.
","
+- Uncontrolled hypertension.
+- Serious allergic reactions to Erythropoietin alfa.
+- Patients who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin should not receive Erythropoietin alfa or any other erythropoietin.
+
","Adverse reactions in 5% of Erythropoietin alfa treated patients in clinical studies were:
+
+- Patients with CKD: Hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection.
+- Zidovudine-treated HIV-infected Patients: Pyrexia, cough, rash, and injection site irritation.
+- Cancer Patients on Chemotherapy: Nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, headache, depression, dysphagia, hypokalemia, and thrombosis.
+- Surgery Patients: Nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension.
+- Premature infants: A fall in serum ferritin values is very common (>10%)
+
","There are no adequate and well-controlled studies in pregnant women. Studies in animals have shown reproduction toxicology. Consequently:
+
+- In chronic renal failure patients, Erythropoietin alfa should be used in pregnancy only if the potential benefit outweighs the potential risk to the foetus.
+- In pregnant or lactating surgical patients participating in an autologous blood predonation programme, the use of Erythropoietin alfa is not recommended.
+
+It is not known whether exogenous Erythropoietin alfa is excreted in human milk. Erythropoietin alfa should be used with caution in nursing women. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Erythropoietin alfa should be made taking into account the benefit of breast feeding to the child and the benefit of Erythropoietin alfa therapy to the woman.
",,,"The therapeutic margin of Erythropoietin alfa is very wide. Erythropoietin alfa overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Erythropoietin alfa dosage and/or with phlebotomy, as clinically indicated. Cases of severe hypertension have been observed following overdose with ESAs.
",,,"Store at 2ºC to 8ºC. Do not freeze or shake. This temperature range should be closely maintained until administration to the patient. Store in original package in order to protect from light.
",10
+429,Erythropoietin,erythropoietin-429,https://medex.com.bd/attachments/DEuk8Tx70KWShudejt81bvRyNvf9az/erythropoietin-prescribing-information,Drugs for Haemolytic Hypoplastic & Renal Anemia,Increase yield of autologous blood,"Erythropoietin is indicated for the treatment of-
+
+- Anemia associated with Chronic Renal Failure, including patients on dialysis and patients not on dialysis.
+- Anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy.
... Read more
Erythropoietin is indicated for the treatment of-
+
+- Anemia associated with Chronic Renal Failure, including patients on dialysis and patients not on dialysis.
+- Anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy.
+- Anemic patients (hemoglobin >10 to <13 g/dL) are scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions.
+- Anemia related to therapy with zidovudine in HIV-infected patients.
+
","Drugs for Haemolytic Hypoplastic & Renal Anemia
",,"Treatment of anemia in chronic renal failure: Erythropoietin is administered to maintain hemoglobin concentration between 11 to 12 g/dl and hematocrit of 33-36 % in adults.
Starting dose:
+
+- Adult: Usually 50 to 100 lU/kg three times in a week (TIW) by IV or Subcutaneous route.
+- Pediatric: 50 lU/kg TIW by IV or Subcutaneous route.
+
+Dose adjustment: Dose should be increased if hematocrit doses not increase by 5 to 6 points after 8 weeks therapy, and hematocrit is below suggested target range. Dose should be reduced when hematocrit approaches 36% or hematocrit increases >4 points in any 2-week period.
Maintenance dose: Maintenance dose must be individualized for each patient. In patients undergoing dialysis, the median maintenance dose is 75 lU/kg TIW, with a range from 12.5 to 525 lU/kg TIW as directed by the physician. In CRF patients not on dialysis, maintenance dose is 75 to 150 lU/kg/week.
Treatment of Anemia in Cancer Patients on Chemotherapy:
Starting dose:
+
+- Adult: 150 lU/kg TIW by Subcutaneous route or 40,000 IU Subcutaneous route weekly.
+- Pediatric: 25 to 300 lU/kg 3 to 7 times per week by Subcutaneous or IV route.
+
+Dose adjustment: If the response is not satisfactory, the dose should be increased to 300 lU/kg TIW. If the hematocrit exceeds 40%, the dose should be withheld until the hematocrit falls to 36%.The dose should be reduced to 25% when treatment is resumed and titrated to maintain the desired hematocrit.
Surgery Patients: The recommended dose is 300 lU/kg/day subcutaneously for 10 days before surgery, on the day of surgery, and for 4 days after surgery. An alternate dose schedule is 600 lU/kg subcutaneously in once weekly dose (21, 14, and 7 days before surgery) plus a fourth dose on the day of surgery.
Zidovudine-treated HIV-infected Patients:
Starting dose
+
+- Adult: 100 lU/kg as an IV or Subcutaneous injection TIW for 8 weeks.
+- Pediatric: 50 to 400 lU/kg 2 to 3 times per week by Subcutaneous or IV route.
+
+Dose adjustment: If the response is not satisfactory, the dose should be increased by 50-1001U/kg TIW. Response should be evaluated every 4 to 8 weeks thereafter and the dose adjusted accordingly by 50 to 100 lU/kg increments TIW.
Maintenance dose: The dose is titrated to maintain the hematocrit between 33-36%.
","
+- Do not shake. It is not necessary to shake Erythropoietin. Prolonged vigorous shaking may denature any glycoprotein, rendering it biologically inactive.
+- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
+- Administer as an intravenous injection over 1-2 minutes. In patients on dialysis, the injection should follow the dialysis procedure. Slow injection over 5 minutes may be beneficial to those who experience flu-like symptoms.
+- Do not administer by intravenous infusion or in conjunction with other drug solutions.
+- For the subcutaneous route, a maximum of 1 ml_ at one injection site should generally not be exceeded. In the case of larger volumes, more than one site should be chosen for the injection.
+
",,"Erythropoietin is contraindicated in patients with:
+
+- Uncontrolled hypertension
+- Known hypersensitivity to mammalian cell-derived products
+- A history of hypersensitivity to Erythropoietin or any component of the preparation.
+
","General: Headache, dizziness, fever, malaise, arthralgia and occasionally hyperkalemia. Cardiovascular: Hypertension is the most common side effect, palpitations. Gastrointestinal: Nausea, vomiting, anorexia and diarrhea may occur occasionally. Allergic reactions.
","Pregnancy Category C. Since there are no controlled studies of erythropoietin in pregnant women, and because animal reproduction studies are not always predictive of human responses, erythropoietin should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when erythropoietin is administered to a nursing woman.
","Erythropoietin should be used with caution in those patients with controlled hypertension, ischaemic vascular disease, history of seizures, or suspected allergy to the product.
Iron evaluation: Prior to and during Erythropoietin therapy, the patient's iron stores, including transferrin saturation and serum ferritin, should be evaluated. Transferrin saturation should be at least 20%, and ferritin should be at least 100 ng/ml. Virtually all patients will require supplemental Iron to increase or maintain transferrin saturation to levels that will adequately support erythropoiesis.
",,"Doses of up to 1500 lU/kg TIW for 3 to 4 weeks have been administered to adults without any direct toxic effects. If the suggested target range is exceeded, drug therapy may be temporarily withheld until the hemoglobin returns to the suggested target range. If polycythemia is of concern, phlebotomy may be indicated to decrease the hemoglobin.
",,,"Erythropoietin should be stored at 2°C to 8°C. Protect from light. Do not freeze & avoid shaking.
",10
+428,Erythromycin (Lotion),erythromycin-lotion-428,https://medex.com.bd/attachments/9ZRe8kvXPcsjDyKUAuF31fKwmHyeZm/erythromycin-lotion-prescribing-information,Topical antibiotics for Acne,Diaper rash,"For topical treatment of acne, pimples & bacterial skin infections susceptible to Erythromycin.
","Topical antibiotics for Acne
","Erythromycin is a bacteriostatic macrolide antibiotic. But may be bactericidal in high concentrations. Although the mechanism by which Erythromycin acts in reducing the inflammatory lesions of acne vulgaris is unknown, it is presumably due to the antibiotic action of the drug.
","Apply in morning and evening to the affected areas. Before applying thoroughly wash with warm water and soap, rinse and pat dry all areas to be treated. Apply with fingertips or applicator. Wash hands after use. Spread the medication lightly rather than rubbing it in. Acne lesions on the face, neck, shoulders, chest and back may be treated in this manner. Additional containers may be used, if needed. Each container should be used once and discarded.
",,"Clindamycin interacts with Erythromycin.
","Hypersensitivity to Erythromycin or to any of the other ingredients of the lotion.
","Erythema, desquamation, burning sensation, eye irritation, tenderness, dryness, oily skin etc.
","Safety for use during pregnancy has not been established. Use only when the potential benefits outweigh potential hazards to the fetus. Erythromycin is excreted in breast milk. Exercise caution when administering to a nursing mother.
","For external use only. Keep away from eyes, nose, mouth and other mucous membrane. Use of antibiotics (especially prolonged or repeated therapy) may result in bacterial or fungal overgrowth of non-susceptible organisms. Such overgrowth may lead to a secondary infection. Take appropriate measures if superinfections occur.
","Safety and effectiveness in children less than 12 years have not been established.
",,,,"Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+427,Erythromycin (Oral),erythromycin-oral-427,https://medex.com.bd/attachments/y3tHw6Ql7z0NQkiqnS4eACIo5K2wpc/erythromycin-oral-tablets-prescribing-information,Macrolides,Susceptible infections,"Erythromycin is highly effective in the treatment of a wide variety of clinical infections.
+
+- Upper respiratory tract infections: Tonsilitis, Peritonsillar abscess, Pharyngitis, laryngitis, Sinusitis. Secondary infections in colds and influenza.
+- Lower respiratory tract infections ... Read more
Erythromycin is highly effective in the treatment of a wide variety of clinical infections.
+
+- Upper respiratory tract infections: Tonsilitis, Peritonsillar abscess, Pharyngitis, laryngitis, Sinusitis. Secondary infections in colds and influenza.
+- Lower respiratory tract infections: Tracheitis, acute and chronic bronchitis.
+- Ear infections: Otitis media, otitis externa, mastoiditis.
+- Eye infections: Blepharitis, established trachoma.
+- Skin and Soft tissue infections: Boils and carbuncles, impetigo, abscesses, pustular acne, paromychia, cellulitis, erysipelas.
+- Gastrointestinal tract infections: Cholecystitis, staphylococcal enterocolitis.
+- Prophylaxis: Pre and post-operative, trauma, burns, rheumatic fever.
+- Other infections: Osteomyelitis, diptheria, scarlet fever, whooping cough.
+
","Anti-diarrhoeal Antimicrobial drugs, Macrolides
","Erythromycin inhibits microsomal protein synthesis in susceptible organisms by inhibiting the translocation process. Specific binding to the 50S subunit or 70S ribosome occurs in these organisms but there is no binding to the stable 80S mammalian ribosome. Erythromycin is active against many Grampositive bacteria, some Gram-negative bacteria and against mycoplasmas and chlamydia.
Absorption: Erythromycin base is destroyed by acid and is therefore administered in the form of stable ester. The rates of absorption of the base and esters are diminished by the presence of food. The stearate is hydrolyzed in the intestine and the free erythromycin absorbed.
Blood concentration: After an oral dose of 500 mg. of the base of stearate, peak serum concentrations of 0.9 to 1.4 or 0.4 to 1.8 mg/ml. respectively are attained in 1 to 4 hours. Half-life: The serum half-life is 1.2 to 4 hours. In subjects with oliguria, the half-life is about 5 hours.
Distribution: Erythromycin is widely distributed throughout body tissue and fluids with some retention in the liver and spleen, protein binding of erythromycin base is 73%. Erythromycin enters the cerebrospinal fluid when the meninges are inflamed. It also crosses the placenta and is excreted in the milk.
Excretion: 5 to 15 % of the dose of erythromycin is excreted in the urine and large amounts of the unchanged active substance are excreted in the bile.
","Adult and Children over 8 years: 250-500 mg every six hours for mild to moderate infections. This may be increased upto 4 gm. or more daily in severe cases.
Elderly: No special dosage recommendation. Erythromycin may be administered if desired, three times daily or twice daily by giving one-third or half of the total daily requirement 8 hourly or 12 hourly respectively.
Children aged 2 to 8 years: 250 mg. every six hours or 30-50 mg/kg body weight per day divided into four equal dosage.
Infants and Children upto 2 years: 500 mg. in divided doses or 30-50 mg/kg body weight in divided doses.
",,"Recent data from studies of erythromycin reveals that its use in patients who are receiving high dosage of theophylline may be associated with an increase of serum theophylline levels and potential theophylline toxicity. In such cases this dose of theophylline should be reduced.
","Known hypersensitivity to Erythromycin.
","Allergic reactions are rare and mild although anaphylaxis has occurred. Occasionally there is abdominal discomfort after oral administration, sometimes with nausea and vomiting. This discomfort usually subsides after a few days without it being necessary to reduce the dosage.
","Clinical and Laboratory studies have been shown no evidence in human of teratogenicity or toxicity. However, caution should be exercised when prescribing this drug to pregnant patients and lactating mothers since erythromycin crosses the placental barrier and is excreted in breast milk.
","Erythromycin should be given with care in patients with impaired hepatic function, as erythromycin is excreted principally in the bile.
",,"In case of overdosage, Erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted. Erythromycin is not removed by peritoneal dialysis or haemodialysis.
",,"Direction for reconstitution of suspension: Shake the bottle to loosen powder. Add 60 ml or 100 ml of boiled and cooled water to the dry powder of the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in suspension.
Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 7 days.
","Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+2058,Ertugliflozin,ertugliflozin-2058,https://medex.com.bd/attachments/M9xkWWe6egoBOu8qjh25NMnNJ9JGi3/ertugliflozin-prescribing-information,Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors,Type 2 DM,"Ertugliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
","Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors
","SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Ertugliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, ertugliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
","Prior to Initiation of Ertugliflozin: Assess renal function prior to initiation of Ertugliflozin and as clinically indicated. In patients with volume depletion, correct this condition before initiating Ertugliflozin.
Recommended Dosage:
+
+- The recommended starting dose of Ertugliflozin is 5 mg once daily, taken in the morning, with or without food.
+- For additional glycemic control, the dose may be increased to 15 mg once daily in patients tolerating Ertugliflozin.
+- Use of Ertugliflozin is not recommended in patients with an eGFR less than 45 mL/min/1.73 m2.
+- Ertugliflozin is contraindicated in patients on dialysis.
+
+
Pediatric Use: The safety and effectiveness of Ertugliflozin in pediatric patients under 18 years of age have not been established.
Geriatrics: Higher incidence of adverse reactions related to reduced intravascular volume.
Renal Impairment: Higher incidence of adverse reactions related to reduced intravascular volume and renal function.
",,,"
+- Hypersensitivity to ertugliflozin or any excipient in Ertugliflozin, reactions such as angioedema have occurred.
+- Patients on dialysis.
+
","The following important adverse reactions are described elsewhere in the labeling:
+
+- Ketoacidosis
+- Lower Limb Amputation
+- Volume Depletion
+- Urosepsis and Pyelonephritis
+- Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues
+- Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene)
+- Genital Mycotic Infections
+
","Based on animal data showing adverse renal effects, Ertugliflozin is not recommended during the second and third trimesters of pregnancy. There is no information regarding the presence of Ertugliflozin in human milk, the effects on the breastfed infant, or the effects on milk production. Ertugliflozin is present in the milk of lactating rats. Since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be risk to the developing human kidney. Because of the potential for serious adverse reactions in a breastfed infant, advise women that the use of Ertugliflozin is not recommended while breastfeeding.
","Ketoacidosis: Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue, evaluate, and treat promptly. Before initiating, consider risk factors for ketoacidosis. Patients may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.
Lower Limb Amputation: Consider factors that may increase the risk of amputation before initiating Ertugliflozin. Monitor patients for infections or ulcers of lower limbs, and discontinue if these occur.
Volume Depletion: May result in acute kidney injury. Before initiating, assess and correct volume status in patients with renal impairment or low systolic blood pressure, elderly patients, or patients on diuretics. Monitor for signs and symptoms during therapy.
Urosepsis and Pyelonephritis: Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.
Hypoglycemia: Consider a lower dose of insulin or insulin secretagogue to reduce risk of hypoglycemia when used in combination.
Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Serious, life-threatening cases have occurred in both females and males. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment.
Genital Mycotic Infections: Monitor and treat if indicated.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+1262,Ertapenem,ertapenem-1262,https://medex.com.bd/attachments/vz9brRQDCbC6eIqhTin1l9DgGsQcfh/ertapenem-prescribing-information,Other beta-lactam Antibiotics,Urinary tract infection,"Ertapenem is a penem antibacterial indicated in adult patients and pediatric patients (3 months of age and older) for the treatment of the following moderate to severe infections caused by susceptible bacteria:
+
+- Complicated intra-abdominal infections.
+- Complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis.
... Read more
Ertapenem is a penem antibacterial indicated in adult patients and pediatric patients (3 months of age and older) for the treatment of the following moderate to severe infections caused by susceptible bacteria:
+
+- Complicated intra-abdominal infections.
+- Complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis.
+- Community-acquired pneumonia.
+- Complicated urinary tract infections including pyelonephritis.
+- Acute pelvic infections including postpartum endomyometritis,
+- septic abortion and post surgical gynecologic infections.
+- Ertapenem is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery.
+
","Other beta-lactam Antibiotics
","The bactericidal activity of ertapenem results from the inhibition of cell wall synthesis and is mediated through ertapenem binding to penicillin binding proteins (PBPs). In Escherichia coli, it has strong affinity toward PBPs 1a, 1b, 2, 3, 4 and 5 with preference for PBPs 2 and 3. Ertapenem is stable against hydrolysis by a variety of beta-lactamases, including penicillinases, and cephalosporinases and extended spectrum beta-lactamases. Ertapenem is hydrolyzed by metallo-beta-lactamases.
","Ertapenem should be infused over 30 minutes in both the Treatment and Prophylactic regimens. Dosing considerations should be made in adults with advanced or end-stage renal impairment and those on hemodialysis.
Treatment regimen:
+
+- Adults and pediatric patients 13 years of age and older. The dosage should be 1 gram once a day intravenously or intramuscularly.
+- Patients 3 months to 12 years of age should be administered 15 mg/kg twice daily (not to exceed 1 g/day intravenously or intramuscularly.)
+- Intravenous infusion may be administered in adults and pediatrics for up to 14 days or intramuscular injection for up to 7 days.
+
+Prophylaxis regimen for adults:
+
+- 1 gram single dose given 1 hour prior to elective colorectal surgery.
+
",,"
+- Co-administration with probenecid inhibits the renal excretion of ertapenem and is therefore not recommended.
+- The concomitant use of ertapenem and valproic acid/divalproex sodium is generally not recommended. Anti-bacterials other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium.
+
","Known hypersensitivity to product components or anaphylactic reactions to β-lactams. Due to the use of lidocaine HCl as a diluent, Ertapenem administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide-type.
","Adults: The most common adverse reactions (≥5%) in patients treated with Ertapenem, including those who were switched to therapy with an oral antimicrobial, were diarrhea, nausea, headache and infused vein complication. In the prophylaxis indication, the overall adverse experience profile was generally comparable to that observed for ertapenem in other clinical trials.
Pediatrics: Adverse reactions in this population were comparable to adults. The most common adverse reactions (≥5%) in pediatric patients treated with Ertapenem, including those who were switched to therapy with an oral antimicrobial, were diarrhea, vomiting and infusion site pain.
","Pregnancy Category B. There are, however, no adequate and well-controlled trials in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Ertapenem is excreted in human breast milk. Caution should be exercised when Ertapenem is administered to a nursing woman. Ertapenem should be administered to nursing mothers only when the expected benefit outweighs the risk.
","
+- Serious hypersensitivity (anaphylactic) reactions have been reported in patients receiving β-lactams.
+- Seizures and other central nervous system adverse experiences have been reported during treatment.
+- Co-administration of Ertapenem with valproic acid or divalproex sodium reduces the serum concentration of valproic acid potentially increasing the risk of breakthrough seizures.
+- Clostridium deficits-associated diarrhea (ranging from mild diarrhea to fatal colitis): Evaluate if diarrhea occurs.
+- Caution should be taken when administering Ertapenem intramuscularly to avoid inadvertent injection into a blood vessel.
+
","Pediatric Use: Safety and effectiveness of Ertapenem in pediatric patients 3 months to 17 years of age are supported by evidence from adequate and well-controlled trials in adults, pharmacokinetic data in pediatric patients, and additional data from comparator-controlled trials in pediatric patients 3 months to 17 years of age.
Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function
Patients with Renal Impairment: Dosage adjustment is necessary in patients with creatinine clearance 30 mL/min or less.
Patients with Hepatic Impairment: The pharmacokinetics of ertapenem in patients with hepatic impairment have not been established.
","No specific information is available on the treatment of overdosage with Ertapenem. Intentional overdosing of Ertapenem is unlikely. Intravenous administration of Ertapenem at a dose of 2 g over 30 min or 3 g over 1-2h in healthy adult volunteers resulted in an increased incidence of nausea. In clinical trials in adults, inadvertent administration of three 1 g doses of Ertapenem in a 24 hour period resulted in diarrhea and transient dizziness in one patient. In pediatric clinical trials, a single intravenous dose of 40 mg/kg up to a maximum of 2 g did not result in toxicity. In the event of an overdose, Ertapenem should be discontinued and general supportive treatment given until renal elimination takes place. Ertapenem can be removed by hemodialysis; the plasma clearance of the total fraction of ertapenem was increased 30% in subjects with end-stage renal disease when hemodialysis (4 hour session) was performed immediately following administration. However, no information is available on the use of hemodialysis to treat overdosage.
",,,"Ertapenem 1 g single dose should be prepared with diluent containers containing 50 mL or 100 mL of 0.9% Sodium Chloride Injection. When prepared with this diluent, Ertapenem for Injection maintains satisfactory potency for 6 hours at room temperature (25°C) or for 24 hours under refrigeration (5°C) and used within 4 hours after removal from refrigeration. Solutions of Ertapenem should not be frozen.
",12
+426,Erlotinib,erlotinib-426,https://medex.com.bd/attachments/8fTdrqP2CYh9g10VUvD7QN4uv3VPv6/erlotinib-prescribing-information,Targeted Cancer Therapy,Pancreatic cancer,"First-line treatment of patients with metastatic Non-Small Cell Lung cancer (NSCLC) whose tumors have Epidermal Growth Factor Receptor (EGFR) exon 19 deletions or exon 21 substitution mutations as detected.
Maintenance treatment of patients with locally advanced or metastatic NSCLC whose ... Read more
First-line treatment of patients with metastatic Non-Small Cell Lung cancer (NSCLC) whose tumors have Epidermal Growth Factor Receptor (EGFR) exon 19 deletions or exon 21 substitution mutations as detected.
Maintenance treatment of patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum based first-line chemotherapy.
Treatment of locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.
First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.
","Targeted Cancer Therapy
",,"NSCLC: The recommended daily dose of Erlotinib for NSCLC is 150 mg taken on an empty stomach, i.e., at least one hour before or two hours after the ingestion of food. Treatment should continue until disease progression or unacceptable toxicity occurs.
Pancreatic Cancer: The recommended daily dose of Erlotinib for pancreatic cancer is 100 mg taken once daily in combination with gemcitabine. Take Erlotinib on an empty stomach, i.e., at least one hour before or two hours after the ingestion of food. Treatment should continue until disease progression or unacceptable toxicity occurs.
Reduce Erlotinib by 50 mg decrements: If severe reactions occur with concomitant use of strong CYP3A4 inhibitors (such as atazanavir, Clarithromycin, Indinavir, Itraconazole, Ketoconazole, Nefazodone, Nelfinavir, Ritonavir, Saquinavir, Telithromycin, Voriconazole or grapefruit or grapefruit juice] or when using concomitantly with an inhibitor of both CYP3A4 and CYP1A2 (e.g., Ciprofloxacin).
Increase Erlotinib by 50 mg increments as tolerated for: Concomitant use with CYP3A4 inducers, such as rifampin, rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital, or St. John's Wort. Increase doses by 50 mg increments at 2 week intervals to a maximum of 450 mg. Avoid concomitant use, if possible.
Concurrent cigarette smoking: Increase by 50 mg increments at 2 week intervals to a maximum of 300 mg. Immediately reduce the dose of Erlotinib to the recommended dose (150 mg or 100 mg daily) upon cessation of smoking.
",,"Anticoagulants: Interaction with coumarin-derived anticoagulants, including warfarin, leading to increased International Normalized Ratio (INR) and bleeding adverse reactions.
CYP3A4 inhibitors: Erlotinib is metabolized predominantly by CYP3A4. Co-treatment with the potent CYP3A4 inhibitor ketoconazole increased Erlotinib AUC by 67%. When Erlotinib was co-administered with Ciprofloxacin, an inhibitor of both CYP3A4 and CYP1A2, the Erlotinib exposure [AUC] and maximum concentration [Cmax] increased by 39% and 17%, respectively.
CYP3A4 inducers: Pre-treatment with the CYP3A4 inducer Rifampicin for 7-11 days prior to Erlotinib decreased Erlotinib AUC by 58% to 80%. Dose modifications are recommended.
Drugs affecting gastric pH: Co-administration of Erlotinib with omeprazole decreased Erlotinib AUC by 46% and co-administration of Erlotinib with Ranitidine 300 mg decreased Erlotinib AUC by 33%.
",,"The most common adverse reactions (20%) with Erlotinib from a pooled analysis of studies were rash, diarrhea, anorexia, fatigue, dyspnea, cough, nausea, and vomiting. The following serious adverse reactions, which may include fatalities.
+
+- Interstitial Lung Disease (ILD)
+- Renal Failure
+- Hepatotoxicity with or without Hepatic Impairment
+- Gastrointestinal Perforation
+- Bullous and Exfoliative Skin Disorders
+- Myocardial Infarction/Ischemia
+- Cerebrovascular Accident
+- Microangiopathic Hemolytic Anemia with Thrombocytopenia
+- Ocular Disorders
+- Hemorrhage in Patients Taking Warfarin
+
","Pregnancy category D. Based on its mechanism of action, Erlotinib can cause fetal harm when administered to a pregnant woman. It is not known whether Erlotinib is present in human milk. Because many drugs are present in human milk and because of the potential for serious adverse reactions in nursing infants from Erlotinib, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
","
+- Interstitial Lung Disease (ILD): Occurs in 1.1% of patients. Withhold Erlotinib for acute onset of new or progressive unexplained pulmonary symptoms, such as dyspnea, cough and fever. Discontinue Erlotinib if ILD is diagnosed.
+- Renal Failure: Monitor renal function and electrolytes, particularly in patients at risk of dehydration. Withhold Erlotinib for severe renal toxicity.
+- Hepatotoxicity with or without hepatic impairment including hepatic failure and hepatorenal syndrome: Monitor periodic liver testing. Withhold or discontinue Erlotinib for severe or worsening liver tests.
+- Gastrointestinal perforations-discontinue Erlotinib.
+- Bullous and exfoliative skin disorders-discontinue Erlotinib.
+- Myocardial infarction (Ml)/ischemia: The risk of Ml is increased in patients with pancreatic cancer.
+
","Pediatric use: The safety and effectiveness of Erlotinib in pediatric patients have not been established.
Geriatric use: No overall differences in safety or efficacy were observed between subjects 65 years and older and those younger than 65.
","Single oral doses of Erlotinib up to 1,000 mg in healthy subjects and weekly doses up to 1,600 mg in cancer patients have been tolerated. Repeated twice-daily doses of 200 mg single-agent Erlotinib in healthy subjects were poorly tolerated after only a few days of dosing. Based on the data from these studies, an unacceptable incidence of severe adverse reactions, such as diarrhea, rash, and liver transaminase elevation, may occur above the recommended dose. In case of suspected overdose, Erlotinib should be withheld and symptomatic treatment instituted.
",,,"Store at a temperature not exceeding 30°C in a dry place. Protect from light and moisture.
",10
+1797,Eribulin Mesylate,eribulin-mesylate-1797,https://medex.com.bd/attachments/XA9sYPcE5cZvYThmfTosxH6gt1DWJ9/eribulin-mesylate-prescribing-information,Targeted Cancer Therapy,Metastatic breast carcinoma,"Eribulin Mesylate is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
","Targeted Cancer Therapy
","Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates. Eribulin exerts its effects via a tubulin-based antimitotic mechanism leading to G2/M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged mitotic blockage.
","The recommended dose of Eribulin Mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
The recommended dose of Eribulin Mesylate in patients with mild hepatic impairment (Child-Pugh A) is 1.1 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
The recommended dose of Eribulin Mesylate in patients with moderate hepatic impairment (Child-Pugh B) is 0.7 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
The recommended dose of Eribulin Mesylate in patients with moderate renal impairment (creatinine clearance of 30-50 mL/min) is 1.1 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
",,"Effects of Other Drugs on Eribulin Mesylate: No drug-drug interactions are expected with CYP3A4 inhibitors or P-gp inhibitors. The effect of ketoconazole, a strong inhibitor of cytochrome P450 3A4 (CYP3A4) and a P-gp inhibitor, on the pharmacokinetics (PK) of eribulin was studied in an open-label, two-treatment, two-sequence, two-way crossover trial in 12 patients with advanced solid tumors. The mean dose-normalized AUC values were similar when eribulin was administered with or without ketoconazole (ratio of the mean AUC: 0.97; 90% CI: 0.83, 1.12).
Effect of Eribulin Mesylate on Other Drugs: Eribulin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4 enzymes or induce CYP1A2, CYP2C9, CYP2C19 or CYP3A4 enzymes at relevant clinical concentrations. Eribulin is not expected to alter the plasma concentrations of drugs that are substrates of these enzymes
",,"The most common adverse reactions (incidence ≥25%) were neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, and constipation.
","Pregnancy Category D. There are no adequate and well-controlled studies with Eribulin Mesylate in pregnant women. It is not known whether Eribulin Mesylate is excreted into human milk. No studies in humans or animals were conducted to determine if Eribulin Mesylate is excreted into milk. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in human milk-fed infants from Eribulin Mesylate, a decision should be made whether to discontinue nursing or to discontinue Eribulin Mesylate taking into account the importance of the drug to the mother.
","Neutropenia: Monitor peripheral blood cell counts and adjust dose as appropriate.
Peripheral Neuropathy: Monitor for signs of neuropathy. Manage with dose delay and adjustment.
Use in Pregnancy: Fetal harm can occur when administered to a pregnant woman.
QT Prolongation: Monitor for prolonged QT intervals in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. Avoid in patients with congenital long QT syndrome.
","Pediatric Use: The safety and effectiveness of Eribulin in pediatric patients below the age of 18 years have not been established.
Geriatric Use: Study 1 did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. Of the 827 subjects who received the recommended dose and schedule of Eribulin in clinical studies, 15% (121/827) were 65 and older, and 2% (17/827) patients were 75 and older. No overall differences in safety were observed between these subjects and younger subjects.
Hepatic Impairment: A lower starting dose is recommended for patients with mild (Child-Pugh A) and moderate (Child-Pugh B) hepatic impairment. Patients with severe hepatic impairment (Child-Pugh C) were not studied.
Renal Impairment: A lower starting dose is recommended for patients with moderate (CrCl 30-50 mL/min) renal impairment. Patients with severe (CrCl < 30 mL/min) renal impairment were not studied.
","Overdosage of Eribulin has been reported at approximately 4 times the recommended dose, which resulted in Grade 3 neutropenia lasting seven days and a Grade 3 hypersensitivity reaction lasting one day. There is no known antidote for Eribulin overdose.
",,,"Store at 25°C; excursions permitted to 15°-30°C. Do not freeze. Store the vials in their original cartons.
",11
+162,Ergotamine Tartrate + Caffeine,ergotamine-tartrate-caffeine-162,https://medex.com.bd/attachments/dS3puEXe1x70gtqNtYPBqJDW3U74pv/ergotamine-tartrate-caffeine-tablets-prescribing-information,Ergot Alkaloids,Acute migraine attacks,"Ergotamine Tartrate and caffeine are indicated as therapy to abort or prevent vascular headache; e.g., migraine, migraine variants or so-called “histaminic cephalalgia.”
","Ergot Alkaloids
","Ergotamine is an α-adrenergic blocker with a direct stimulating effect on the smooth muscle of peripheral and cranial blood vessels, it also depresses central vasomotor centers.
Caffeine is also a cranial vasoconstrictor.
","Usual Adult Dose for Cluster Headache:
+Oral, Sublingual: 2 mg ergotamine in fixed combination with caffeine given as quickly as possible after the first symptom of headache. Additional 1 mg doses can be given every 30 minutes until the headache has been aborted or until a total dose of 6 mg has been reached or 10 mg/week.
Rectal: 2 mg ergotamine in fixed combination with caffeine given as quickly as possible after the first symptom of headache. An additional 2 mg dose can be given 1 hour later if the first dose fails to abort the headache. The total dose should not exceed 4 mg/attack or 10 mg/week.
+
Usual Adult Dose for Migraine:
+Oral, Sublingual: 2 mg ergotamine in fixed combination with caffeine given as quickly as possible after the first symptom of headache. Additional 1 mg doses can be given every 30 minutes until the headache has been aborted or until a total dose of 6 mg has been reached or 10 mg/week.
Rectal: 2 mg ergotamine in fixed combination with caffeine given as quickly as possible after the first symptom of headache. An additional 2 mg dose can be given 1 hour later if the first dose fails to abort the headache. The total dose should not exceed 4 mg/attack or 10 mg/week.",,,"Not to be used with potent inhibitors of CYP3A4 and protease inhibitors. Hyperthyroidism, renal or hepatic impairment. Pre existing vascular disease including coronary disease, obliterative vascular disease, angina, claudication, peripheral ischaemia, Raynaud's syndrome and hypertension. Not to be used when there is sepsis. Pregnancy and lactation.
","Increased BP, hypotension, rapid and weak pulse, palpitations, arrhythmias, precordial pain, coronary infarction, fibrotic thickening of the heart valves. Cerebral ischaemia and thrombosis, blurred vision, sleep disturbances, urinary retention, muscle cramps and joint pains.
GI symptoms such as nausea, vomiting, constipation, abdominal pain. Dysaesthesia, paraesthesia, formication, tremor, convulsions, headache, extrapyramidal effects. Anxiety, depression, confusion, hallucinations, psychomotor impairment.
","Pregnancy: Category X. This medicine should not be used during pregnancy as it may be harmful to the unborn baby.
Lactation: Significant amounts of this medicine may pass into breast milk. It should not be used by breastfeeding mothers as it may be harmful to the nursing infant.
","Not to be taken regularly or used for migraine prophylaxis. Increased risk of arterial constriction and other symptoms of ergotism. Discontinue treatment when symptoms of arterial occlusion occur e.g. numbness and tingling of the extremities. Caution when used in patients with infective hepatitis, cardiac disease or anaemia. GI tract obstructive disease, glaucoma, prostatic hypertrophy or urinary retention may be worsened by cyclizine. May increase risk of retroperitoneal and/or pleuropulmonary fibrosis. Not recommended for use with other vasoconstrictors. Elderly.
","Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Renal Dose Adjustments: Contraindicated in patients with renal dysfunction
Liver Dose Adjustments: Contraindicated in patients with liver dysfunction
","Acute overdosage:
+
+- Symptoms: Nausea, vomiting, diarrhoea, extreme thirst, coldness, weakness, tingling and itching of the skin, rapid and weak pulse, hypotension, shock, confusion, convulsions and unconsciousness. BP may be difficult to measure; may result in fatalities. Further symptoms of peripheral vasoconstriction or CV disturbances may occur but be delayed.
+- Treatment includes using activated charcoal to reduce absorption. General supportive measures should be instituted. IV vasodilators such as sodium nitroprusside infusion may be required to relieve vasospasm. Peritoneal dialysis and forced diuresis may be used to remove ergotamine from the body.
+
+Chronic overdosage:
+
+- Symptoms: Peripheral ischaemia of the extremities, especially the feet and legs. Gangrene may develop in the toes and fingers. Anginal pain, tachycardia or bradycardia and BP fluctuations may occur. Excessive use may lead to pleural and peritoneal fibrosis. Rebound headache may occur and is a major withdrawal symptom following the development of ergotamine dependence.
+- Treatment: IV vasodilators e.g. nitroprusside and nitroglycerin may be used to re-establish normal blood flow. Captopril may be used to reverse the effects of chronic overdosage with ergotamine.
+
",,,"Store below 25°C.
",11
+425,Ergometrine Maleate,ergometrine-maleate-425,https://medex.com.bd/attachments/wTrxWWTEvXTeXQDyelGVvWuuSjGSFe/ergometrine-maleate-prescribing-information,Drugs acting on the Uterus,Uterine bleeding,"Active management of the third stage of labour, Treatment and prophylaxis of postpartum haemorrhage, Excessive uterine bleeding, Postpartum and post-abortion bleeding
","Drugs acting on the Uterus
","Ergometrine causes contraction of the uterine muscle. At low doses, there is an increase in frequency and amplitude of contractions while at higher doses, the basal tone of the uterus is increased. Ergometrine also causes vasoconstriction of peripheral and cerebral vessels.
","Intramuscular (Adult)-
+
+- Active management of the third stage of labour: 0.5 mg given with 5 units of oxytocin after delivery of the anterior shoulder of the infant or immediately after delivery.
+- Treatment and prophylaxis of postpartum haemorrhage: 0.2 mg, may repeat in severe bleeding every 2-4 hr as needed.
+
+Intravenous (Adult)-
+
+- Excessive uterine bleeding: 0.2 mg via IV inj over at least 1 minute. May follow with oral doses of 0.2 to 0.4 mg 2-4 times daily until the danger of atony or haemorrhage has passed (usually 48 hr).
+
+Oral (Adult)-
+
+- Postpartum and post-abortion bleeding: 0.2 to 0.4 mg 2-4 times daily until danger of uterine atony and haemorrhage has passed (usually 48 hr). Max duration: 1 wk postpartum.
+
",,"Halothane causes relaxation of uterine muscle and may interfere with ergometrine action. Enhanced uterotonic effect with prostaglandins and oxytocin. Concurrent admin with CYP3A4 inhibitors may lead to vasospasm, cerebral ischaemia and/or ischaemia of extremities.
","Pregnancy, 1st and 2nd stage of labour, patients with preeclampsia, eclampsia or threatened spontaneous abortion; porphyria.
","Nausea, vomiting, abdominal pain, diarrhoea; headache, dizziness; tinnitus; chest pain, palpitation, bradycardia, transient hypertension and other cardiac arrhythmias; dyspnoea, sometimes rashes, shock
","Pregnancy Category X. Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
","Breech and abnormal foetal presentation; hypertension; chronic anaemia; hepatic, renal, respiratory or cardiac impairment; toxemia; lactation; hypocalcaemia. Monitor BP, pulse and uterine response.
",,"Symptoms include peripheral vasoconstriction, encephalopathy, convulsions, respiratory failure, acute renal failure and temporary lactose intolerance. Treatment is supportive.
",,,"Intramuscular: Active management of the third stage of labour: Refrigerate at 2-8°C.
Intravenous: Refrigerate at 2-8°C.
Oral: Store below 25°C.
",11
+1284,Erdosteine,erdosteine-1284,https://medex.com.bd/attachments/MCieFSHinEyR6XDJM9wiNCuFKMQTZa/erdosteine-prescribing-information,Cough expectorants & mucolytics,Chronic obstructive pulmonary disease (COPD),"Erdosteine is a mucolytic drug used in the treatment of acute and chronic respiratory diseases. It also improves the symptoms associated with short episodes of chronic bronchitis.
","Cough expectorants & mucolytics
","Erdosteine is a prodrug that is metabolised into N-thiodiglycolyl-homocysteine whereby free thiol groups are formed leading to the opening of the disulphide bonds of the bronchial mucoproteins, thus reducing the viscosity of mucus and purulent sputum. It also antagonises the local formation of free radicals and inhibits elastase enzyme activity and bacterial adhesion to epithelial cells.
","The usual dose of elderly patients and adults above 18 years is 1 capsule twice daily for 10 days. But study shows that in chronic cases Erdosteine can be given up to 12 months or as directed by the physician. Erdosteine capsule may be taken with or without food.
",,,"It is contraindicated to patients who have hypersensitivity to Erdosteine. It should not be used in patients with creatinine clearance <25 ml/min, or with severe liver failure.
","Common side effect is epigastric pain. Other side effects include headache, cold, taste alterations, nausea, vomiting, diarrhea, angioedema and other skin allergic reactions.
","The use of Erdosteine in pregnant or breast-feeding women is not recommended.
","It should be used with caution in mild liver failure. In that case, should not exceed a dose of 300 mg per day.
","Renal Impairment: CrCl <25 ml/min: Contraindicated.
Hepatic Impairment:
+
+- Mild to moderate: Max: 300 mg daily.
+- Severe: Contraindicated.
+
",,,,"Keep in a dry place away from light and heat. Keep out of reach of children
",10
+1651,Ethyl Butylacetylaminopropionate,ethyl-butylacetylaminopropionate-1651,,Miscellaneous topical agents,Insect repellent,"This cream acts against dengue, chikungunya, zika, malaria, and filariasis. It protects up to 8 hours. Ethyl Butylacetylaminopropionate is used for over 30 years.
","Miscellaneous topical agents
","Ethyl butylacetylaminopropionate (trade name IR3535) is an insect repellent. As ethyl butylacetylaminopropionate is solely a repellent, it has no killing action and does not give rise to selection pressure or development of resistance. It is a colorless and almost odorless oil and is intended to be applied to the skin of humans and animals. It has a broad efficacy against various insects like mosquitoes, ticks, lice, and other bugs. Ethyl butylacetylaminopropionate is safe for use on infants, pregnant and breastfeeding women. It is biodegradable and completely degraded in the environment within a very short time.
","Apply liberally on exposed areas of the body as often as needed. For best results, reapply every 8 hours.
",,,,,,"Do not apply to eyes, lips, mouth, cuts, and wounds, or irritated skin. This is for external use only.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",6
+444,Etodolac,etodolac-444,https://medex.com.bd/attachments/tZ6FjWdwmWfPcnBjEi0IDgInOOn3ch/etodolac-prescribing-information,Drugs for Osteoarthritis,Rheumatoid arthritis,"Etodolac is indicated-
+
+- For acute and long-term use in the management of signs and symptoms: Osteoarthritis, Rheumatoid arthritis
+- For the management of acute pain
+- Acute gout
+
","Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Similar to other NSAIDs, the anti-inflammatory effects of etodolac result from inhibition of the enzyme cycooxygenase (COX). This decreases the synthesis of peripheral prostaglandins involved in mediating inflammation. Etodolac binds to the upper portion of the COX enzyme active site and prevents its substrate, arachidonic acid, from entering the active site. Etodolac was previously thought to be a non-selective COX inhibitor, but it is now known to be 5-50 times more selective for COX-2 than COX-1. Antipyresis may occur by central action on the hypothalamus, resulting in peripheral dilation, increased cutaneous blood flow, and subsequent heat loss.
","Adults and over 18 years:
+
+- Etodolac 300 mg capsule: 600 mg daily in 1-2 divided doses
+- Etodolac 600 mg ER tablet: Once daily
+
+Pediatric: Safety and effectiveness in pediatric patients below the age of 18 years have not been established.
",,"Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors. When Etodolac is administered with Aspirin, its protein binding is reduced, although the clearance of free Etodolac is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of Etodolac and Aspirin is not generally recommended because of the potential of increased adverse effects.
","Etodolac is contraindicated in patients with known hypersensitivity to Etodolac. Etodolac should not be given to patients who have experienced asthma, urticaria or other allergic type reactions after taking Aspirin or other NSAIDs.
","The common side effects of Etodolac involve the gastrointestinal system. It can cause abdominal pain, constipation, diarrhea, dyspepsia, flatulence, heartburn, nausea, Gl ulcers, vomiting. Other events including abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritis, rashes, tinnitus etc.
","There are no adequate and well-controlled studies in pregnant women. It should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Etodolac is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother.
","Etodolac should be given with caution in patients with severe hepatic reactions, pre existing asthma, fluid retention, hypertension or heart failure. If clinical sings and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g. eosinophilia, rash etc.), it should be discontinued.
",,"Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain which are generally reversible with supportive care.
",,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",11
+1585,Ethyl Alcohol + Hydrogen peroxide + Glycerol,ethyl-alcohol-hydrogen-peroxide-glycerol-1585,https://medex.com.bd/attachments/u3iy2GkX3ri7lwF2Yw9NKwTC05LMQs/ethyl-alcohol-hydrogen-peroxide-glycerol-prescribing-information,Bleaching and Disinfectants,Disinfection,"For the disinfection of clean and intact skin. For pre-operative surgical hand disinfection, hand disinfection on the ward prior to aseptic procedures or after handling contaminated materials. For disinfection of the patients’ skin prior to surgery or other invasive procedures
","Bleaching and Disinfectants
","Glycerol: used as humectant, but other emollients may be used for skin care, provided that they are cheap, widely available and miscible in water and alcohol and do not add to toxicity, or promote allergy.
Hydrogen peroxide: used to inactivate contaminating bacterial spores in the solution and is not an active substance for hand antisepsis.
Any further additive to both formulations should be clearly labelled and be non-toxic in case of accidental ingestion.
A colorant may be added to allow differentiation from other fluids, but should not add to toxicity, promote allergy, or interfere with antimicrobial properties. The addition of perfumes or dyes is not recommended due to risk of allergic reactions.
","As required
",,,,,,,,,,,"Should be stored in cool and dry place
",5
+443,Ethosuximide,ethosuximide-443,https://medex.com.bd/attachments/8LB1OodKOxyv9iHZPhC2SUUKsQlvd0/ethosuximide-prescribing-information,Primary anti-epileptic drugs,Seizures,"Ethosuximide is indicated for the control of absence (petit mal) epilepsy.
","Primary anti-epileptic drugs
","Ethosuximide suppresses the paroxysmal three cycle per second spike and wave activity associated with lapses of consciousness which is common in absence (petit mal) seizures. The frequency of epileptiform attacks is reduced, apparently by depression of the motor cortex and elevation of the threshold of the central nervous system to convulsive stimuli.
","Ethosuximide is administered by the oral route. The initial dose for patients 3 to 6 years of age is 250 mg per day; for patients 6 years of age and older, 500 mg per day. The dose thereafter must be individualized according to the patient's response. Dosage should be increased by small increments. One useful method is to increase the daily dose by 250 mg every four to seven days until control is achieved with minimal side effects. Dosages exceeding 1.5 g daily, in divided doses, should be administered only under the strictest supervision of the physician. The optimal dose for most pediatric patients is 20 mg/kg/day. This dose has given average plasma levels within the acceptedtherapeutic range of 40 to 100 mcg/mL. Subsequent dose schedules can be based on effectiveness and plasma level determinations.
Ethosuximide may be administered in combination with other anticonvulsants when other forms of epilepsy coexist with absence (petit mal). The optimal dose for most pediatric patients is 20 mg/kg/day.
",,"Isoniazid may increase the serum concentration of ethosuximide, leading to toxicity. Antipsychotics, antidepressants, MAOIs, and mefloquine may antagonise anticonvulsant effects of ethosuximide. Plasma conc of ethosuximide may be reduced by carbamazepine, phenobarbital, phenytoin, and primidone; and affected by valproate. Chloroquine or hydroxychloroquine may increase risk of convulsions. Isoniazid.
","Hypersensitivity. Pregnancy and lactation.
","Blood toxicities and disorders; headache, fatigue, lethargy, drowsiness, dizziness, ataxia, hiccup and mild euphoria; more rarely, psychotic states, rashes, hepatic and renal changes, and haematological disorders. SLE, erythema multiforme. Gum hypertrophy, swelling of tongue, irritability, hyperactivity, sleep disturbances, night terrors, inability to concentrate, aggressiveness, increased libido, myopia, vag bleeding.
","Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Hepatic or renal impairment, porphyria. Complete blood cell count, liver function tests, and urinalysis should be performed periodically. May increase the risk of grand mal seizures when used alone in mixed types of epilepsy. Avoid sudden withdrawal. May impair ability to drive or operate machinery.
",,,,,,9
+1677,Ethinyl Estradiol + Lynestrenol (0.05 mg),ethinyl-estradiol-lynestrenol-005-mg-1677,,Oral Contraceptive preparations,Oral contraceptives,"লাইনেসট্রেনল ও ইথিনাইল এস্ট্রাডিয়েল একটি কম্বাইন্ড গর্ভনিরোধক পিল যা খাওয়ার গর্ভনিরোধক হিসাবে নির্দেশিত।
","Oral Contraceptive preparations
",,"মাসিক শুরু হওয়ার প্রথম দিনেই প্রথম প্যাকেটের প্রথম ট্যাবলেটটি খেতে হবে। ব্রান্ড বদল করে অন্য ব্রান্ডের খাওয়ার গর্ভনিরোধক ব্যবহারের বেলায়ও একই পদ্ধতি অনুসরণ করতে হবে। ২২ দিনের এক দিনও ছেদ না ঘটিয়ে প্রতিদিন একই সময়ে একটি করে বড়ি খেতে হবে। বাকি ৬ দিন হল ট্যাবলেট-মুক্ত সময়। বড়ি মুক্ত সময়ের মেয়াদ ওই ৬ দিন শেষ হওয়ার পর পরবর্তী প্যাকেটে ট্যাবলেট খাওয়া শুরু করতে হবে।
","আপনি যদি বর্তমানে কোন ট্যাবলেট না খানঃ
+
+- পরবর্তী মাসিক শুরু হওয়া পর্যন্ত অপেক্ষা করুন। মাসিক শুরুর প্রথম দিন হতে প্যাকেটের উপরের সারি থেকে নির্দিষ্ট দিন চিহ্নিত প্রথম এই ট্যাবলেট খাওয়া শুরু করুন, যেমন আপনার মাসিক যদি বুধবার শুরু হয় তাহলে প্যাকেটের উপরের সারি থেকে বুধবার চিহ্নিত ট্যাবলেটটি খান । একই নিয়মে প্রতিদিন একই সময়ে তীর চিহ্ন অনুসরণ করে ১ টি করে ট্যাবলেট খেয়ে ২২ টি ট্যাবলেট খাওয়া শেষ করুন। মনে রাখবেন আপনার মাসিকের প্রথম দিন থেকে ট্যাবলেট খাওয়া শুরু করলে এবং কোন ট্যাবলেট খাওয়া ভুলে না গেলে আপনাকে অতিরিক্ত কোন সতর্কতামূলক জন্মনির���ধক ব্যবস্থা গ্রহণ করতে হবেনা ।
+- আপনার মাসিকের যদি ইতিমধ্যে ৫ দিন অতিক্রান্ত হয়ে যায় তাহলে মাসিক শুরুর দিনকে প্রথম দিন হিসাব করে পঞ্চম দিন থেকে প্রথম ট্যাবলেট খাওয়া শুরু করুন । এই ৫ দিনের মধ্যে মাসিকের নিঃসরণ বন্ধ হয়ে গেলেও কোন অসুবিধা নাই । তীর চিহ্ন অনুসরণ করে পুরা প্যাকেটের ট্যাবলেট (১ নং পয়েন্টে বর্ণিত নিয়মানুযায়ী) খাওয়া শেষ করুন । এই ক্ষেত্রে ট্যাবলেট গ্রহনের প্রথম ১৪ দিন আপনার সঙ্গীকে অবশ্যই অতিরিক্ত সতর্কতামূলক জন্ম নিরোধক ব্যবস্থা (যেমন- কনডম) ব্যবহার করতে হবে ।
+- যদি আপনার মাসিক ৫ দিনের বেশী সময় আগে শুরু হয়ে থাকে সেক্ষেত্রে আপনাকে এই ট্যাবলেট গ্রহনের জন্য পরবর্তী মাসিক শুরু হওয়া পর্যন্ত অপেক্ষা করতে হবে।
+
",,"
+- কার্ডিওভাসকুলার ব্যাধি, যেমন- থ্রোম্বফ্লেবাইতিস ও থ্রোম্বএম্বলিক প্রসেস অথবা অতীতে এসব অবস্থার সৃষ্টি হলে।
+- মারাত্মক রকমের উচ্চ রক্তচাপ।
+- লিভারের মারাত্মক রকমের রোগ অথবা যদি পরীক্ষায় দেখা যায় লিভার ফাংশন স্বাভাবিক অবস্থায় ফিরে আসতে ব্যর্থ হয়েছিল এমন পূর্ব বিবরণ জানা থাকলে, কোলেস্ট্যাটিক জন্ডিস; গর্ভাবস্থায় জন্ডিস অথবা স্টেরয়েড ব্যবহারের ফলে জন্ডিসের পূর্ব বিবরণ থাকলে; রোটোর সিনড্রোম ও ডুবিন-জনসন সিনড্রোম।
+- এস্ট্রোজেন-নির্ভর টিউমার থাকলে অথবা সন্দেহ করলে।
+- এন্ডোমেট্রিয়াল হাইপারপ্লাসিয়া।
+- অজ্ঞাত কারণে ভ্যাজাইনাল রক্তস্রাব হলে।
+- পোরফাইরিয়া।
+- হাইপার লাইপোপ্রোটিনামিয়া, বিশেষ করে কার্ডিওভাসকুলার রোগের সম্ভাবনা বাড়িয়ে দিতে পারে এমন রিস্ক ফ্যাক্টরের উপস্থিতিতে।
+- গর্ভাবস্থায় বা তার আগে সিভিয়ার প্রুরাইটাসে অথবা হারপেস জেসটেশনাইটিস-এ স্টেরয়েড ব্যবহারের পূর্ব বিবরণ থাকলে।
+- আপনার বয়স যদি ৩৫ বছরের বেশী হয় এবং আপনি যদি ধুমপায়ী হন তাহলে এই পিল খেতে আপনাকে অবশ্যই ধুমপান পরিহার করতে হবে।
+
","প্রাথমিক পর্যায়ে কারও কারও সাময়িক কিছু পার্শ্ব প্রতিক্রিয়া যেমন, মাথা ব্যাথা, বমি বমি ভাব, ওজন বৃদ্ধি, মানসিকতার পরিবর্তন, স্তনে ব্যাথা, উচ্চ রক্তচাপ, ধমনীতে রক্ত জমাট বাধা, যকৃত এবং বৃক্কের কার্যক্ষমতার অসুবিধা ইত্যাদি হতে পারে।
","গর্ভাবস্থায় ইহা ব্যবহার করা যাবে না।
","আপনি যদি এক বা ���কাধিক ট্যাবলেট খাওয়া ভুলে যানঃ
যদি নির্দিষ্ট সময়ে ট্যাবলেট খাওয়া না হয় এবং ১২ ঘন্টা অতিক্রম না করে তাহলে যখনই মনে পড়বে তখনই ভুলে যাওয়া ট্যাবলেটটি খেয়ে নিন। পরবর্তী ট্যাবলেট গুলি নিয়মানুযায়ী সঠিক সময়ে খাবেন। এই ক্ষেত্রে ট্যাবলেটের পূর্ণ কার্যক্ষমতা বজায় থাকবে। যদি ১২ ঘন্টার বেশী সময় পার হয় তবে ট্যাবলেটের কার্যক্ষমতা কমে যায়। এক্ষেত্রে পরবর্তী দিন আপনাকে দুটি ট্যাবলেট খেতে হবে। প্রথম ভুলে যাওয়া ট্যাবলেটটি যখন মনে পড়বে তখনই খাবেন এবং অপরটি নিয়মানুযায়ী দিনের নির্দিষ্ট সময়ে খাবেন। পুরা প্যাকেটের ট্যাবলেট নিয়ম মত খাওয়া শেষ করুন। এক্ষেত্রে পরবর্তী ১৪ দিন অথবা আপনার পরবর্তী মাসিকের শুরু, যেটা সর্বাধিক সেই পর্যন্ত আপনার সঙ্গীকে অবশ্যই অতিরিক্ত সতর্কতামূলক জন্ম নিরোধক ব্যবস্থা (যেমন-কনডম) ব্যবহার করতে হবে।
",,,,"আলো থেকে দূরে, ২°C-৩০°C তাপমাত্রায় শুষ্ক স্থানে রাখুন। শিশুদের নাগালের বাইরে রাখুন। অতিরিক্ত শুষ্ক , ঠান্ডা এবং আলোবিহীন স্থানে সংরক্ষণ করুন।
",,9
+442,Ethinyl Estradiol + Lynestrenol (0.0375 mg),ethinyl-estradiol-lynestrenol-00375-mg-442,,Oral Contraceptive preparations,Oral contraceptives,"লাইনেসট্রেনল ও ইথিনাইল এস্ট্রাডিয়েল একটি কম্বাইন্ড গর্ভনিরোধক পিল যা খাওয়ার গর্ভনিরোধক হিসাবে নির্দেশিত।
","Oral Contraceptive preparations
",,"প্রতিদিন যথাসম্ভব একই সময়ে নির্দেশ অনুযায়ী পিল খেতে হবে। আপনার মাসিক শুরুর প্রথম দিনই পিল খেতে শুরু করবেন। মাসিকের ২-৫ দিনের ভিতরে যে কোন দিন পিল খাওয়া শুরু করা যায় , কিন্তু সেইক্ষেত্রে প্রথম মাসে পিল খাওয়াকালীন প্রথম সাত দিন কনডম ব্যবহার করা উচিত। প্রতিদিন ১ টি করে , পর পর ২২ দিন পিল খাবেন। ৬ দিনের পিল মুক্ত সময়ের পর পরবর্তী নতুন প্যাকেট থেকে পিল খাওয়া শুরু করবেন ।
এই ৬ দিনের ভিতরেই আপনার মাসিক হবে যা কখনো কখনো পরবর্তী প্যাকেট শুরুর আগে পর্যন্ত চলতে পারে। মাসিক চলতে থাকলেও এই পিল এর পরবর্তী প্যাকেট সপ্তম দিনে আরম্ভ করুন। আপনি যত দিন সন্তান না চাইবেন , ততদিন এই নিয়মে পিল খাওয়া চালিয়ে যাবেন।
",,"অ্যাম্পিসিলিন, টেট্রাসাইক্লিন, বারবিচুরেটস, হাইড্যান্টয়েনস, প্রিমিডন, কার্বামাজেপিন ও রিফামপিসিন এই জাতীয় কিছু কিছু ঔষধ পিলের কার্যকারিতা কমিয়ে দিতে পারে। পিল খাওয়াকালীন সময়ে যদি আরও কোন ঔষধ কোন কা���নে খাওয়ার প্রয়োজন পড়ে তাহলে অবশ্যই ডাক্তারের সাথে পরামর্শ করুন।
","যে সব ক্ষেত্রে আপনি কম্বাইন্ড গর্ভনিরোধক ব্যবহার করতে পারবেন না-
+
+- ভেনাস থ্রম্বসিস বর্তমানে উপস্থিত অথবা পূর্বে ছিল
+- কার্ডিওভাসকুলার অ্যাক্সিডেন্ট ও মায়োকার্ডিয়াল ইনফারকশন অথবা ব্যাধির পূর্ব লক্ষণ
+- ডায়াবেটিস মেলিটাসের সঙ্গে সংবহণ নালী সংক্রান্ত লক্ষণ থাকলে
+- মারাত্মক রকমের উচ্চ রক্তচাপ
+- সিভিয়ার ডিসলিপোপ্রোটিনেমিয়া
+- জন্মগত অথবা অন্য কোন ভাবে ভেনাস অথবা আর্টারিয়াল থ্রম্বসিসের প্রবণতা থাকলে
+- জনন অঙ্গসমূহ, স্তন অথবা লিভারে ম্যালিগন্যান্ট অবস্থার কথা জানা থাকলে অথবা সন্দেহ করলে
+- লিভারের জটিল রোগ থাকলে এমনকি লিভার ফাংশন স্বাভাবিক অবস্থায় ফিরে আসতে ব্যর্থ হওয়ার পূর্ব বিবরন থাকলে
+- অজ্ঞাত কারণে ভ্যাজাইনাল ব্লিডিং হলে
+- এই পিলের যে কোন উপাদানে অতি সংবেদনশীলতা থাকলে
+
","প্রাথমিক পর্যায়ে কারও কারও সাময়িক কিছু পার্শ্ব প্রতিক্রিয়া যেমন মাথা ব্যাথা, মাথা ঘোরা, বমি বমি ভাব অথবা পিল খাওয়াকালীন সময়ে সামান্য ফোটা ফোঁটা আকারে মাসিক হতে পারে। কিন্তু নিয়মিত পিল খেতে থাকলে স্বাভাবিকভাবেই এই সমস্ত উপসর্গ দুই থেকে তিন মাসের মধ্যে দূরীভূত হয়ে যাবে। এই সকল উপসর্গের জন্য অতিরিক্ত চিন্তিত হবার কোন কারণ নাই। তবে পার্শ্ব প্রতিক্রিয়া যদি আরও বেশি দিন চলতে থাকে তখন অবশ্যই ডাক্তারের পরামর্শ নিতে হবে।
","গর্ভধারণ করলে অথবা এ ব্যাপারে সন্দেহ দেখা দিলে কম্বাইন্ড গর্ভনিরোধক ব্যবহার করতে পারবেন না।
","যদি নির্দিষ্ট সময়ে পিল না খাওয়া হয় এবং যদি ১২ ঘন্টা অতিক্রম না করে তা হলে পিলের কার্যক্ষমতা বজায় থাকে। এক্ষেত্রে যখনই মনে পড়বে তখনই পিলটি খেয়ে নিন এবং পরের পিল গুলি সঠিক সময়ে খাবেন।
যদি ১২ ঘন্টার বেশী সময় পার হয় তবে পিলের কার্যক্ষমতা কমে যায়। তখন আপনাকে নিম্নলিখিত নিয়ম পালন করতে হবে। মনে রাখবেন ১ম ও ৩য় সপ্তাহে যে কোন দিন পিল খেতে ভুলে গেলে বিশেষ সতর্কতার প্রয়োজন। অন্যথায় গর্ভধারনের ঝুঁকি বেশি হতে পারে।
প্রথম সপ্তাহে পিল খেতে ভুলে গেলে এবং ভুলে যাওয়ার আগে ঐ সন্তাহে যৌন মিলন করে থাকলে ডাক্তারের পরামর্শ নিন । যদি যৌন মিলন না করে থাকেন তাহলেঃ
+
+- ভুলে যাওয়া ট্যাবলেটটি খান
+- সাতদিন অতিরিক্ত সাবধানতা গ্রহন করুন
+- প্যাক শেষ করুন
+
+দ্বিতীয় সপ্তাহে পিল খেতে ভুলে গেলেঃ
+
+- ভুলে যাওয়া ট্যাবলেটটি খান
+- প্যাক শেষ করুন
+
+তৃতীয় সপ্তাহে পিল খেতে ভুলে গেলেঃ
+
+- ভুলে যাওয়া ট্যাবলেটটি খান
+- প্যাক শেষ করুন
+- ট্যাবলেটহীন বিরতি বাদ দিন
+- পরবর্তী প্যাক শুরু করুন
+
+অথবা
+
+- বর্তমান প্যাক বন্ধ করুন
+- ট্যাবলেটহীন বিরতি পালন করুন
+- ভুলে যাওয়া ট্যাবলেটের দিনসহ ৬ দিনের বেশি নয়
+- পরবর্তী প্যাক শুরু করুন
+
+প্যাকের একাধিক পিল ভুলে গেলে অবশ্যই ডাক্তারের পরামর্শ নিতে হবে। আপনি যদি প্যাকের পিল খেতে ভুলে যান এবং প্রথম পিল মুক্ত দিনে আপনার মাসিক না হয় তবে আপনি গর্ভবতী হতে পারেন। পরবর্তী প্যাক আরম্ভের আগে ডাক্তারের পরামর্শ নিন।
সতর্কতাঃ
অন্যান্য শারীরিক অবস্থা, যার জন্য সংবহনগত সমস্যা দেখা দিতে পারে, কিন্তু কম্বাইন্ড গর্ভনিরোধক ব্যবহারের সঙ্গে কোন সম্পর্ক নাই এই সকল ক্ষেত্রে অবশ্যই সতর্কতার প্রয়োজন। যেমন- ডায়াবেটিস মেলিটাস, সিষ্টেমিক লুপাস এরিথমেটোসাস, হিমোলাইটিক ইউরেমিক সিনড্রোম, পেটের নাড়িতে দীর্ঘস্থায়ী প্রদাহ ইত্যাদি এই সকল ক্ষেত্রে অবশ্যই সতর্কতার প্রয়োজন আছে। ঘন ঘন মাইগ্রেন দেখা দেওয়া, টিউমার, লিভারের কার্যকারিতার দীর্ঘদিনের সমস্যা এই সকল ক্ষেত্রেও সতর্কতার প্রয়োজন। বাচ্চাকে বুকের দুধ দিচ্ছেন এমন মহিলাদেরও সতর্কতার প্রয়োজন কারণ কম্বাইন্ড গর্ভনিরোধক পিল বুকের দুধের পরিমান এবং গুনগতমানের পরিবর্তন করতে পারে। ডায়াবেটিক আছে এমন মহিলারা খাওয়ার কম্বাইন্ড গর্ভনিরোধক ব্যবহারকালে বিশেষ করে যখন খাওয়া শুরু করবেন, তখন সতর্কতার প্রয়োজন। যে সব মহিলার ক্ষেত্রে ক্লোয়েসমা গ্রাভিডেরামের পূর্ব বিবরণ রয়েছে তারা চড়া রোদ উপেক্ষা করবেন।
কম্বাইন্ড গর্ভনিরোধক পিল ব্যবহারকারীদের নিম্নলিখিত অনাকাঙ্খিত সমস্যাসমূহ, যেমন স্তনের স্পর্শকাতরতা, মাথাধরা, মাইগ্রেন, কন্টাক্টলেন্সে অস্বস্তিবোধ হওয়া, ত্বকের বিভিন্ন সমস্যা, ইডিমা, শারীরিক ওজনের পরিবর্তন ইত্যাদি দেখা দিলে ডাক্তারের পরামর্শ নিন।
",,,,,"আলো থেকে দূরে, ২°C-২৫°C তাপমাত্রায় শুষ্ক স্থানে রাখুন। শিশুদের নাগালের বাইরে রাখুন।
",9
+441,Ethinyl Estradiol + Levonorgestrel + Ferrous Fumarate,ethinyl-estradiol-levonorgestrel-ferrous-fumarate-441,https://medex.com.bd/attachments/sYlTg5IoVaSKEAUXeKgAKjejl5GK8s/ethinyl-estradiol-levonorgestrel-ferrous-fumarate-prescribing-information,Oral Contraceptive preparations,Oral contraceptives,"This pill is indicated in-
+
+- Inhibit Ovulation
+- Inhibit sperm to enter into the uterus by condensing uterine mucus
+- Inhibit fertilized egg to accept by uterus by protecting the growth of membrane inside the uterus
+- It reduces the movement of sperm by minimizing normal movement of fallopian tube. So sperms die as it takes long time to come into contact of Ova
... Read more
This pill is indicated in-
+
+- Inhibit Ovulation
+- Inhibit sperm to enter into the uterus by condensing uterine mucus
+- Inhibit fertilized egg to accept by uterus by protecting the growth of membrane inside the uterus
+- It reduces the movement of sperm by minimizing normal movement of fallopian tube. So sperms die as it takes long time to come into contact of Ova
+
+This pill is Suitable for:
+
+- Women aged between 15-69 years (except smoker and who use tobacco regularly)
+- Women who want an effective, temporary contraceptive method
+- Women who is suffering from anemia due to excessive blood loss during menstruation
+- Women having irregular menstruation cycle
+- Breastfeeding mother (if child age is more than 6 months).
+
","Oral Contraceptive preparations
","This pill is an effective, temporary and short term birth control management for women. This tablet contains two hormones, Levonorgestrel and Ethinyl Estradiol. Every single strip contains 28 tablets from which 21 tablets contains hormone and 7 tablets contains Iron. Combination oral contraceptives lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanism may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.
","One should start taking this tablet from the first day of menstruation. It can be starts any day in first 5 days of menstruation. One tablet should be taken same time of each day with food, but best time is after dinner or before sleeping at night. Start your dose with one white tablet each day for 3 (three) weeks. After that, take one brown color tablet each day for 7(seven) days. If menstruation starts while taking brown color tablet, don’t stop the medicine. If not pregnant is confirmed then dose can be start from any day of menstruation, but after menstruation must have to use condom during sexual intercourse for next 7 (seven) days. When 7(seven) brown tablet finished, either menstruation starts or not, start the dose from beginning with white Tablet.
If forget to take tablet for a day, one should take the tablet as soon as patient noticed it, and take another tablet as the dose of present day. If forget to take the tablet for consecutive two days, then this contraceptive will not work. However, to maintain the date of menstruation cycle one should take two tablets at a time as soon as patient noticed it.
",,"With medicine: Drugs or herbal products that induce certain enzymes, including CYP3A4 may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with COCs.
With food and other: It is recommended to avoid caffeine, dairy foods, phytic acid containing food while taking the drug.
","Contraindicated in case of known hypersensitivity to any of the components of this product.
","Common: Headache, nausea, mood changes including depression, vaginal infections, irregular vaginal bleeding, pain and discomfort. Rare: liver tumors, jaundice, high blood pressure & gallbladder problem.
","This pill is contraindicated in pregnancy. Discontinue this pill if pregnancy occurs. Combined hormonal contraceptives (CHCs) and/or metabolites are present in human milk and in breast-fed infants. CHCs including this pill can reduce milk production in breastfeeding females.
","
+- Thrombotic disorder and other vascular problems: Stops this pill if a thrombotic disorder occurs. Stop at least 4 weeks before through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery in women who are not breastfeeding
+- Liver disease: Discontinue this pill if jaundice occurs
+- High blood pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop this pill if blood pressure rises significantly
+- Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking this pill. Consider an alternative contraceptive method for women with uncontrolled dyslipidemia
+- Headache: Evaluate significant change in headaches and discontinue this pill if indicated
+- Bleeding irregularities and amenorrhea: Evaluate irregular bleeding or amenorrhea
+
","Safety and efficacy of this pill have been established in women of reproductive age. Efficacy is expected to be the same in post-pubertal adolescents under the age of 18 years as for users 18 years and older. Use of this product before menarche is not indicated.
","There have been no reports of serious illness effects from overdose of oral contraceptives including ingestion by children. Over dosage may cause withdrawal bleeding in females and nausea.
",,,"Store below 30°C, protected from light & moisture. Keep all medicines out of reach of children.
",12
+1179,Ethinyl Estradiol + Gestodene,ethinyl-estradiol-gestodene-1179,https://medex.com.bd/attachments/EZzwjHCU0J6FsWvRoZdoCYwAPBdwej/ethinyl-estradiol-gestodene-prescribing-information,Oral Contraceptive preparations,Oral contraceptives,"This pill is indicated for the prevention of pregnancy.
","Oral Contraceptive preparations
","This contains two active ingredients, Gestodene and Ethinylestradiol. Ethinylestradiol is a synthetic version of oestrogen and Gestodene is a synthetic form of progesterone. If this tablet is taken according to instructions the egg cells (normally released by the ovary each month) are prevented from maturing to the point where they can be fertilized. Secondary mechanisms, which may contribute to the effectiveness of Gestop 28 as a contraceptive, include changes in the cervical mucus (which increase the difficulty of sperm penetration) and changes in the endometrium (which reduce the likelihood of implantation).
","How to Take this pill: To achieve maximum contraceptive effectiveness, Gestodene & Ehinylestradiol must be taken in the order directed on the package and at intervals not exceeding 24 hours. Women should be instructed to take the tablets at about the same time every day, preferably after the evening meal or at bedtime. One tablet is to be taken daily for 28 consecutive days. Each subsequent pack is started on the day after the current pack is completed.
+
+- If you have decided to take Gestodene & Ehinylestradiol for contraception, wait for your next menstruation begins.
+- From the first day of your menstruation, start taking the first white tablet from the left corner of the top row (with arrow mark indicating begin) of your Gestodene & Ehinylestradiol tablet pack.
+- Continue taking one white tablet each day along the arrow mark.
+- After taking 21 white tablets for 21 days, then continue taking the light red placebo tablet every day from the last row in the pack for next 7 days.
+- It is most likely that your menstruation will start while taking the light red inactive tablets. Do not discontinue taking the light red inactive tablets. Taking of the light red tablets for 7 days will help you keep your tablet taking routine. If your menstruation does not start during this time, check with your doctor to make sure you are not pregnant.
+- After completing the seven light red inactive tablets, start taking white active tablets from another Gestodene & Ehinylestradiol pack and continue taking the tablet as long as you don't want to be pregnant.
+
+
Management of Missed Tablets: If you forgot to take a tablet one day, take the missed tablet as soon as you remember. This may mean taking two tablets the very next day. Additionally you should use some other method of contraception while you are taking the tablets & until your next menstruation.
+
If you forget to take the tablets for two continuous days, then it is likely that you will no longer be protected against pregnancy. You should therefore discontinue taking the tablet and adopt some other temporary methods (condom/foam tablet) till your next menstruation. Discard the unfinished pack of tablets and start taking tablets from the very first white tablet of the top row from a fresh pack from the first day of next menstruation.
+
How to Delay a Period: To delay a period you should continue with another new pack of Gestodene & Ehinylestradiol just after finishing the white active tablet of the present pack (that is no need to take light redplacebo tablet of present pack). The extension can be carried on for as long as wished until the end of the second pack. When you wish your period to begin, just stop tablet taking. While using the second pack woman may have some breakthrough bleeding or spotting. Start with your next pack after the usual 7 day light red inactive tablet interval.
+
Advice in Case of Vomiting: If vomiting occurs within 3-4 hours after white active tablet taking, absorption may not be complete. In such an event, the advice concerning Management of Missed Tablets is applicable. The woman must take the extra active tablet(s) needed from a back up pack after vomiting.
",,"
+- Interactions between ethinyloestradiol and other drugs may lead to decreased or increased ethinyloestradiol concentrations, respectively. Decreased ethinyloestradiol serum concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the oral contraceptive. Example of substances that may decrease serum ethinyloestradiol concentrations include rifampicin, phenytoin, primidone, rifabutin, dexamethasone, griseofulvin, topiramate, some protease inhibitors, modafinil, ritonavir and barbiturates.
+- Certain antibiotics including ampicillin, other penicillins and tetracyclines may reduce the efficacy of oral contraceptives.
+- During concomitant use of Gestodene & Ehinylestradiol & other drugs that may lead to decreased ethinyloestradiol serum concentrations, it is recommended that a non hormonal back-up method of contraception to be used in addition to the regular intake of this pill.
+
",,"At the initial stage some women may experience side-effects like dizziness, headache, nausea, diarrhea, abdominal pain, weight gain, fluid retension, depression, mood changes, breast pain, breast tenderness, rash, vaginal discharge, erythema etc. If taken regularly, such types of side-effects normally lessen with time. If she continues to have the side effects beyond 2-3 months, she could consult with a doctor.
","Use during pregnancy: The administration of this pill is contraindicated during pregnancy.
Use during lactation: The use of this pill during breast-feeding is not recommended.
","Some medications may interfere with the efficacy of the tablet. Contact your doctor if you are taking any drugs, such as antibiotics, rifampicin or medicines for seizures. You may have to use another method of contraception during this time.
",,"Symptoms of oral contraceptive overdosage in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness, fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.
",,,"Store in a cool, dry place. Keep away from light & out of reach of children.
",10
+1888,Ethinyl Estradiol + Drospirenone + Levomefolate,ethinyl-estradiol-drospirenone-levomefolate-1888,https://medex.com.bd/attachments/2laBCM7aBQVIHFUESrwWobR2w5bN00/ethinyl-estradiol-drospirenone-levomefolate-prescribing-information,Oral Contraceptive preparations,Oral contraceptives,"Oral Contraceptive: This is indicated for use by women to prevent pregnancy.
Premenstrual Dysphoric Disorder (PMDD): This contraceptive preparation is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose ... Read more
Oral Contraceptive: This is indicated for use by women to prevent pregnancy.
Premenstrual Dysphoric Disorder (PMDD): This contraceptive preparation is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of This contraceptive preparation for PMDD when used for more than three menstrual cycles has not been evaluated. The essential features of PMDD according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. In this disorder, these symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school, or with usual social activities and relationships with others. Diagnosis is made by healthcare providers according to DSM-IV criteria, with symptomatology assessed prospectively over at least two menstrual cycles. In making the diagnosis, care should be taken to rule out other cyclical mood disorders. This contraceptive preparation has not been evaluated for the treatment of premenstrual syndrome (PMS).
Acne: This is indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. This contraceptive preparation should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
Folate Supplementation: This contraceptive preparation is indicated in women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.
","Oral Contraceptive preparations
",,"How to Take this contraceptive pill: Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly. To achieve maximum contraceptive and PMDD effectiveness, this contraceptive pill must be taken as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered.
How to Start this contraceptive pill: Instruct the patient to begin taking this contraceptive pill either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start).
Day 1 Start: During the first cycle of this contraceptive pill use, instruct the patient to take one pink contraceptive pill daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one pink contraceptive pill daily for 24 consecutive days, followed by one light orange tablet daily on Days 25 through 28. this contraceptive pill should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. this contraceptive pill can be taken without regard to meals. If this contraceptive pill is first taken later than the first day of the menstrual cycle, this contraceptive pill should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as backup during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.
Sunday Start: During the first cycle of this contraceptive pill use, instruct the patient to take one pink contraceptive pill daily, beginning on the first Sunday after the onset of her menstrual period. She should take one pink contraceptive pill daily for 24 consecutive days, followed by one light orange tablet daily on Days 25 through 28. this contraceptive pill should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. this contraceptive pill can be taken without regard to meals. this contraceptive pill should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as backup during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.
The patient should begin her next and all subsequent 28-day regimens of this contraceptive pill on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her pink tablets on the next day after ingestion of the last light orange folate tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of this contraceptive pill is started later than the day following administration of the last light orange tablet, the patient should use another method of contraception until she has taken a pink contraceptive pill daily for seven consecutive days.
When switching from a different birth control pill: When switching from another birth control pill, this contraceptive pill should be started on the same day that a new pack of the previous oral contraceptive would have been started.
",,"Drugs or herbal products that induce certain enzymes (for example, CYP3A4) may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs.
","
+- Renal impairment
+- Adrenal insufficiency
+- A high risk of arterial or venous thrombotic diseases
+- Undiagnosed abnormal uterine bleeding
+- Breast cancer or other estrogen- or progestin-sensitive cancer
+- Liver tumors or liver disease
+- Pregnancy
+
","The most frequent adverse reactions (≥ 2%) in contraception, acne and folate clinical trials are headache/migraine (5.9%), menstrual irregularities (4.1%), nausea/vomiting (3.5%) and breast pain/tenderness (3.2%). The most frequent adverse reactions (≥ 2%) in PMDD clinical trials are menstrual irregularities (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and affect lability (2.1%)
","Nursing mothers: Not recommended; can decrease milk production.
","Vascular risks: Stop this contraceptive pill if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. COCs containing DRSP may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing levonorgestrel or some other progestins. Before initiating this contraceptive pill in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE.
Hyperkalemia: DRSP has antimineralocorticoid activity. Do not use in patients predisposed to hyperkalemia. Check serum potassium concentration during the first treatment cycle in women on long-term treatment with medications that may increase serum potassium concentration.
Liver disease: Discontinue this contraceptive pill if jaundice occurs.
High blood pressure: Do not prescribe this contraceptive pill for women with uncontrolled hypertension or hypertension with vascular disease.
Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking this contraceptive pill. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.
Headache: Evaluate significant change in headaches and discontinue this contraceptive pill if indicated.
Uterine bleeding: Evaluate irregular bleeding or amenorrhea.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+1635,Ethinyl Estradiol + Drospirenone (HRT),ethinyl-estradiol-drospirenone-hrt-1635,,Drugs for menopausal symptoms: Hormone replacement therapy,Hormone replacement therapy,"Hormone replacement therapy (HRT) for the treatment of:
+
+- Climacteric syndrome in postmenopausal women including vasomotor symptoms (such.as hot flushes and sweating attacks), sleep disorders, depressed moods, nervousness and atrophic, urogenital conditions caused by deficient endogenous estrogen production due to natural menopause, hypogonadism, castration or primary ovarian failure in women with an intact uterus.
+- Prevention of postmenopausal osteoporosis.
+
","Drugs for menopausal symptoms: Hormone replacement therapy
","173-estradiol, which is chemically and biologically identical to endogenous human E2, and the synthetic progestogen, DRSP. 173-estradiol provides hormone replacement during and after the climacteric. The addition of DRSP helps to provide bleeding control and opposes the development of endometrial hyperplasia caused by estrogens.
Effects of estradiol: The loss of the ovarian function, accompanied by a depletion of estrogen and progesterone production, leads to the menopausal syndrome, characterized by vasomotor and organic symptoms. Hormone replacement therapy is indicated to eliminate these complaints. Of all physiological estrogens, E2 is the most potent one with the highest affinity to the estrogen receptor. Estrogen target organs include, in particular, uterus, hypothalamus, pituitary, vagina, breast, bones (osteoclasts).
Other effects of estrogens include reduction of insulin and blood glucose concentrations local vasoactive effects mediated by receptors, and receptor-independent effects on vascular smooth muscle. Estrogen receptors have been identified in the heart and coronary arteries. Oral administration of natural estrogens is advantageous in certain cases of hypercholesterolemia in order to maximize beneficial metabolic liver effects on lipids.
","How to start: Women who do not take estrogens or women who change from a continuous combination product may start treatment at any time. Women changing from a continuous sequential or cyclic HRT should complete the current cycle of therapy before initiating this therapy.
Dosage: One tablet is taken daily.
Missed tablets: In case a tablet is forgotten, it should be taken as soon as possible. If more than 24 hours have elapsed, no extra tablet needs to be taken. If several tablets are forgotten, bleeding may occur
","Each pack covers 28 days of treatment. Treatments continuous, which means that the next pack follows immediately without a break. The tablets are to be swallowed whole with some liquid irrespective of food intake. The tablets should preferably be taken at the same time every day. For the treatment of postmenopausal symptoms, the lowest effective dose should be used. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used.
","An increased clearance of sex hormones due to hepatic enzyme induction may reduce the clinical efficacy of the drug and eventually cause irregular bleeding. Such hepatic enzyme-inducing properties have been established for hydantoins, barbiturates, primidone, carbamazepine, and rifampicin and are also suspected for oxcarbazepine, topiramate, felbamate and griseofulvin. The mechanism of this interaction appears to be based on the hepatic enzyme-inducing properties of these drugs. Maximal enzyme induction is generally not seen for 2-3 weeks but may then be sustained for at least 4 weeks after the cessation of drug therapy. In rare cases reduced E2 levels have been observed under the simultaneous use of certain antibiotics (e.g. penicillins and tetracycline).
The main metabolites of DRSP are generated without involvement of the cytochrome P450 system. Inhibitors of this enzyme system are therefore unlikely to influence the metabolism of DRSP. Nevertheless, inhibitors of'CYP3A4, like cimetidine, ketoconazole and others, may inhibit the metabolism of E2.
+
+- Interaction with alcohol
+- Acute alcohol ingestion during use of HRT may lead to elevations
+- Known or suspected premalignant conditions or malignancies, if sex steroid-influenced
+- Presence or history of liver tumors (benign or malignant)
+- Severe hepatic disease
+- Presence or history of severe renal disease as long as renal function values have not returned to normal
+- Acute arterial thromboembolism (e.g. myocardialinfarction, stroke)
+- Active deep venous thrombosis,thromboembolic disorders,or a documented history of these conditions
+- A high risk of venous or arterial thrombosis
+- Severe hypertriglyceridemia
+- Pregnancy or lactation (see section 4.6 Pregnancy and lactation)
+- Hypersensitivity to the active substances or to any of the excipients
+
","Hormone replacement therapy (HRT) should not be started in the presence of any of the conditions listed below. The product should be stopped immediately, if any of the conditions appear during HRT use.
+
+- Undiagnosed abnormal genital bleeding
+- Known or suspected cancer of the breast
+- Known or suspected premalignant conditions or malignancies, if sex steroid-influenced
+
+The excess risk disappears within a few years after stopping HRT. HRT increases the density of mammographic images which may adversely affect the radiological detection of breast cancer in some cases.
Endometrial cancer: Prolonged exposure to unopposed estrogens increases the risk of development of endometrial hyperplasia or carcinoma. The addition of DRSP opposes the development of endometrial hyperplasia caused by estrogens.
Liver tumors: In rare cases benign, and even more rarely, malignant liver tumors have been observed after the use of hormonal substances such as those contained in HRT products. In isolated cases, these tumors led to life-threatening intra-abdominal hemorrhage.
","The most commonly reported adverse drug reactions (ADRs) with Ethinylestradiol & Drospirenone are breast pain, female genital tract bleeding and gastrointestinal and abdominal pains. They occur in >6% of users. Bleeding irregularities usually subside during continued treatment. The frequency of bleeding decreases with the duration of treatment. Serious adverse reactions are arterial and venous thromboembolic events as well as breast cancer
","Ethinylestradiol & Drospirenone must not be used during pregnancy and lactation. If pregnancy occurs during medication with Ethinylestradiol & Drospirenone, treatment must be discontinued immediately. Small amounts of DRSP are excreted with the milk.
","Before initiating therapy, all conditions/risk factors mentioned below should be considered when determining the individual benefit/risk of treatment for the patient. During HRT use, therapy should be discontinued immediately in case a contraindication is discovered, as well as in the following situations:
+
+- Migrainous or frequent and unusually severe headaches that occur for the first time or other symptoms that are possible prodromal of cerebrovascular occlusion.
+- Recurrence of cholestatic jaundice or cholestatic pruritus which occurred first during pregnancy or previous use of sex steroids.
+- Symptoms of a thrombotic event.
+
+In the event of new onset or deterioration of the following conditions or risk factors, the individual benefit/risk analysis should be re-done, taking into consideration the possible necessity of discontinuing therapy. The potential for an increased synergistic risk of thrombosis should be considered in women who possess a combination of risk factors or exhibit a greater severity of an individual risk factor. This increased risk may be greater than a simple cumulative risk of the factors. HRT should not be prescribed in case of a negative risk benefit assessment.
Venous thromboembolism: Both randomized-controlled and epidemiological studies have suggested an increased relative risk of developing venous thromboembolism (VTE), i.e. deep venous thrombosis or pulmonary embolism. Benefit/Risk should therefore be carefully weighed in consultation with the patient when prescribing HRT to women with a risk factor for VIE. Generally recognized risk factors for VTE include a personal history, a family history (the occurrence of VTE in a direct relative at a relatively early age may indicate genetic disposition) and severe obesity. The risk of VTE also increases with age. There is no consensus about the possible role of varicose veins in VTE. The risk of VTE may be temporarily increased with prolonged immobilization, major elective or post-traumatic surgery, or major trauma. Depending on the nature of the event and the duration of the immobilization, consideration should be given to a temporary discontinuation of HRT.
","Children and adolescents: This is not indicated for use in children and adolescents.
Geriatric patients: There are no data suggesting a need for dosage adjustment in elderly patients.
Patients with hepatic impairment: In women with mild or moderate hepatic impairment, DRSP is well tolerated. This is
contraindicated in women with severe hepatic disease
Patients with renal impairment: In women with mild or moderate renal impairment, a slight increase of DRSP exposure was observed but is not expected to be of clinical relevance. This is contraindicated in women with severe renal disease.
","Acute toxicity studies indicate that, even in the case of inadvertent intake of a multiple of the therapeutic dose, no acute toxicity risk is to be expected. In clinical studies up to 100 mg of DRSP and estrogen/ progestogen preparations containing 4 mg E2 were well tolerated.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",13
+396,Ethinyl Estradiol + Drospirenone (24 tablet),ethinyl-estradiol-drospirenone-24-tablet-396,https://medex.com.bd/attachments/XKqQnyhDdUCauydGEViwnRIqtPmoIC/ethinyl-estradiol-drospirenone-24-tablet-prescribing-information,Oral Contraceptive preparations,Premenstrual dysmorphic disorder,"This tablet is indicated for:
+
+- As an oral contraceptive
+- Treatment of moderate acne vulgaris
+- Treatment of premenstrual dysphoric disorder (PMDD)
+
","Oral Contraceptive preparations
","This contains two active ingredients- Ethinylestradiol and Drospirenone. Ethinylestradiol is a synthetic version of estrogen and Drospirenone is a synthetic form of progesterone. The hormonal components of this preparation inhibit ovulation by suppressing gonadotropin release. Secondary mechanisms, which may contribute to the effectiveness of this tablet as a contraceptive, include changes in the cervical mucus (which increase the difficulty of sperm penetration) and changes in the endometrium (which reduce the likelihood of implantation).
Drospirenone has antimineralocorticoid activity, counteracting estrogen-related sodium retention. In combination with Ethinyloestradiol, Drospirenone displays a favorable lipid profile with an increase in high-density lipoprotein HDL. Drospirenone exerts antiandrogenic activity and does not counteract the ethinyloestradiol-related sex hormone-binding globulin increase which is useful for binding and inactivating the endogenous androgens.
","To achieve maximum contraceptive effectiveness tablets must be taken in the order directed on the package every day at about the same time. Tablet-taking should be started with the first pink tablet of the upper row & have to continue daily for 24 consecutive days. After completion of pink tablet, white tablet should be taken from 25th day to 28th day. Withdrawal bleeding usually starts on days 2-3 after starting the white tablets & don't stop taking white tablets though your menstruation is already started. Each subsequent new pack is started on the day after the last white tablet of the previous pack.
No preceding hormonal contraceptive use in the past month: Tablet taking has to start on day 1 of the woman’s menstrual cycle. The woman should be instructed to take the first light pink active tablet from the upper row of this tablet according to the direction and in this case no additional methods of contraception are required. Starting on days 2-5 is allowed, but during the first cycle a barrier method is recommended in addition for the first 7 days of tablet-taking.
Changing from another combined hormonal pill or vaginal ring or transdermal patch: In case of combined hormonal pill, woman should start with the first light pink tablet of upper row on the day after the last active tablet of her previous COC. In case of a vaginal ring or transdermal patch has been used, the woman should start using this tablet preferably on the day of removal.
Changing from a progestogen-only-method (minipill, injection, implant) or from a progestogen-releasing intrauterine system (IUS): The woman may switch any day from the minipill (or from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due), but should in all of these cases be advised to additionally use a barrier method (like-condom) for the first 7 days of tablet-taking.
Following first-trimester abortion: The woman may start immediately and in this case no need to take additional contraceptive method.
Following delivery or second-trimester abortion: Women are advised to start at day 21 to 28 after delivery or second-trimester abortion. When starting later, the woman are advised to additionally use a barrier method (like-condom) for the first 7 days of tablet-taking.
","Management of Missed Tablets: Missed white pills from the last row of the blister are placebo tablets and thus can be disregarded. But if you forgot to take a light pink tablet one day, take the missed tablet as soon as you remember. This may mean taking two tablets the very next day. Additionally you should use some other method of contraception (like a condom) until next 7 days. If you forget to take the tablets for two continuous days, then it is likely that you will no longer be protected against pregnancy. You should therefore discontinue taking the tablet and adopt some other temporary methods (condom/foam tablet) till your next menstruation. Discard the unfinished pack of tablets and start taking tablets from the light pink tablet of the top row of a fresh pack from the first day of next menstruation.
If you have missed a period after taking tablet: If you have taken all of your pills at the right time and you have not vomited or used other medicines then you are very unlikely to be pregnant. Continue to take tablet as usual. If you miss your period twice in a row, you may be pregnant. Tell your doctor immediately. Do not start the next pack of this tablet until your doctor has checked you are not pregnant.
How to Delay a Period: To delay period women should continue with another new pack of this tablet just after finishing the light pink active tablet of the present pack (that is no need to take white placebo tablet of present pack). The extension can be carried on for as long as wished until the end of light pink color tablet of the second pack. When women wish their period to begin, just stop tablet taking. While using the second pack woman may have some breakthrough bleeding or spotting. Start with your next pack after the usual 4 day white inactive tablet interval.
Advice in case of Vomiting: If vomiting occurs within 3-4 hours after light pink tablet taking, absorption may not be complete. In such an event, the advice concerning management of missed tablets is applicable. The woman must take the extra active tablet (light pink color) needed from a back up pack after vomiting.
","Interactions between ethinylestradiol and other drugs may lead to decreased or increased ethinylestradiol concentrations, respectively. Decreased ethinylestradiol serum concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the oral contraceptive. Example of substances that may decrease serum ethinylestradiol concentrations include rifampicin, phenytoin, primidone, rifabutin, dexamethasone, griseofulvin, topiramate, some protease inhibitors, modafinil, ritonavir and barbiturates. Certain antibiotics including ampicillin, other penicillins and tetracyclines may reduce the efficacy of oral contraceptives. During concomitant use of this tablet & other drugs that may lead to decreased ethinylestradiol serum concentrations, it is recommended that a non hormonal back-up method of contraception to be used in addition to the regular intake of this tablet.
","This tablet should not be used:
+
+- Known or suspected pregnancy
+- If you have heart disease, clotting of blood in the vein
+- If you suffer from liver disease or jaundice
+- If you suffer from high blood pressure, migraine, feel something hard in your breast, diabetes with vascular involvement, experience excessive bleeding for which no reason has yet been ascertained
+- The presence or a history of venous or arterial thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction or of a cerebrovascular accident)
+- History of migraine with focal neurological symptoms
+- Pancreatitis or a history thereof if associated with severe hypertriglyceridaemia
+- Severe renal insufficiency or acute renal failure
+- Presence or history of liver tumours (benign or malignant)
+- Undiagnosed vagina! bleeding
+- Hypersensitivity to any of the components of this preparation.
+
","Different types of tablet suit to different types of woman. At the initial stage some women may experience side-effects like dizziness, headache, breast pain, nausea or unscheduled uterine bleeding. These symptoms may occur in >3% of users. After starting one brand of oral contraceptive tablets, if you feel any inconvenience such as migraine, changes in eyesight or speech, unusual pain or swelling in your legs, sharp chest pains or shortness of breath, rash, yellow skin or a rise in blood pressure take immediate advice from your doctor.
","Use during pregnancy: This is contraindicated during pregnancy. Pregnancy must be excluded before starting this tablet. If pregnancy occurs during use of this tablet, the preparation must be withdrawn immediately. Women who discontinue oral contraceptives with the intent of becoming pregnant, a non-hormonal method of contraception is recommended for three months before attempting to conceive.
Use during lactation: Lactation may be influenced by combined pill as they may reduce the quantity and change the composition of breast milk, therefore the use of estrogen containing combined pill should generally not be recommended until the nursing mother has completely weaned her child. Small amounts of the contraceptive steroids and/or their metabolites may be excreted with the milk.
","If any circulatory disorder (like- myocardial infarction, deep venous thrombosis, pulmonary embolism, cerebrovascular injury etc) or other risk factors(like smoking, obesity, hypertension, dyslipidemia, migraine, atrial fibrillation etc) are present, the benefits of COC use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start using it. In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors after taking pill, the woman should contact with her physician. The physician should then decide on whether its use should be discontinued.
","Pediatric Use: This is only indicated after menarche. There is no data suggesting the need for a dosage adjustment.
Use in the Elderly: This is not indicated after menopause.
","Symptoms of oral contraceptive overdose may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.
",,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",13
+1804,Ethinyl Estradiol + Drospirenone (21 tablet),ethinyl-estradiol-drospirenone-21-tablet-1804,,Oral Contraceptive preparations,Oral contraceptives,"This is indicated in oral contraception.
","Oral Contraceptive preparations
","This is a combined oral contraceptive tablet containing the synthetic progestogen, drospirenone and the synthetic estrogen, ethinylestradiol. The contraceptive effect of this tablet is based on the interaction of various factors, the most important of which are seen as the inhibition of ovulation and the changes in cervical secretion. When this tablet is taken according to instructions, the egg cells are prevented from maturing to the point at which they can be fertilized, the cervical mucus remains thick so as to constitute a barrier to sperm and the endometrium is rendered unreceptive to implantation. As well as protection against pregnancy, estrogen/progestogen combinations have several positive properties which, next to the negative properties, can be useful in deciding on the method of birth control. The cycle is more regular and the menstruation is often less painful and bleeding is lighter.
Drospirenone has antimineralocorticoid activity, counteracting estrogen related sodium retention. In combination with ethinylestradiol, drospirenone displays a favourable lipid profile with an increase in high-density lipoprotein HDL. Drospirenone exerts antiandrogenic activity and does not counteract the ethinylestradiol-related sex hormone binding globulin (SHBG) increase which is useful for binding and inactivating the endogenous androgens. Drospirenone is devoid of any androgenic, estrogenic, glucocorticoid and antiglucocorticoid activity. This in combination with the antimineralocorticoid and antiandrogenic properties, gives drospirenone a biochemical and pharmacological profile closely resembling the natural hormone progesterone.
","When and how to take the tablets: The this tablet pack contains 21 tablets. On the pack, each tablet is marked with the day of the week on which it is to be taken. Take your tablet at about the same time each day, with some water if necessary. Follow the direction of the arrows until all 21 tablets have been taken. During the next 7 days don't take any tablet. A period should begin during these 7 days (the withdrawal bleed), unusually it will start on day 2-3 after the last this tablettablet. Start taking your next pack on the 8th day even if your period continues. This means that you will always start new packs on the same day of the week and also that you have your withdrawal bleed on about the same days each month.
Starting your first pack of this tablet: When no hormonal contraceptive has been used in the past month. Start taking this tablet on the first day of your cycle, i.e. the first day of menstrual bleeding. Take a tablet marked with that day of the week. For example, if your period starts on a Sunday, take a tablet marked Sunday. Then follow thedaysin order. You may also start on days 2-5 of your cycle, but in that case make sure you also use an additional contraceptive method (barrier method) for the first 7 days of tablet-taking in the first cycle.
When changing form another combined Pill: You can start taking this tablet the day after you have the last tablet from your present Pill pack (this means no tablet-free break). If your present Pill pack also contains inactive tablets you can start this tablet on the day after taking the first active tablet (if you are not sure which this is, ask your doctor or pharmacist). You can also start later, but never later than the day following the tablet free break of your present Pill (or the day after the last inactive tablet of your present Pill).
When changing from progestogen-only Pill (Mini Pill): You can stop taking the mini pill any day and start taking this tablet the next day, at the same time. But make sure you also use an additional-contraceptive method (a barrier method) for the first 7 days of tablet-taking when having intercourse.
When changing from an Injectable or Implant: Start using this tablet when your next injection is due or on the day that your implant is removed. But make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet-taking when having intercourse.
After having a baby: If you have just had a baby, your doctor may tell you to wait until after your first normal period before you start taking this tablet. Sometimes it is possible to start sooner. Your doctor will advise you. If you are breast-feeding and want to take this tablet you should discuss this first with your doctor.
After a miscarriage or an abortion: Your doctor will advise you.
If too many this tablet tablets are taken (overdose): There have been no reports of serious harmful effects from taking too many this tablet tablets at one time. If you have taken several tablets at a time, you may have nausea, vomiting or vaginal bleeding. If you discover that a child has taken this tablet ask your doctor for advice.
When you want to stop taking this tablet: You can stop taking this tablet at any time you want. If you do not want to become pregnant, ask your doctor about other methods of birth control. If you stop taking this tablet because you want to get pregnant, it is generally recommended that you wait until you have had a natural period before trying to conceive.
","If you forget to take tablets
+
+- If you are less than 12 hours late in taking a tablet, the reliability of the Pill is maintained. Take the tablet as soon as you remember and take the next tablets at the usual times.
+- If you are more than 12 hours late in taking any tablet, the reliability of the Pill may be reduced. The more consecutive tablets you have missed, the higher the risk that the contraceptive efficacy is decreased. There is a particularly high risk of becoming pregnant if you miss tablets at the beginning or at the end of the pack. Therefore, you should follow the rules given below.
+
+More than one tablet forgotten in a pack: Ask your doctor for advice.
+
+- 1 tablet missed in week 1: Take the missed tablet as soon as your remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. Use extra contraceptive precautions (barrier method) for the next 7 days. If you had sexual intercourse in the week before missing the tablets, there is a possibility of becoming pregnant. So tell your doctor immediately.
+- 1 tablet missed in week 2: Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. The reliability of the Pill is maintained. You need not use extra contraceptive precautions.
+- 1 tablet missed in week 3: You may choose either of the following options, without the need for extra contraceptive precautions.
+
+Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. Start the next pack as soon as the current pack is finished so that no gap is left between packs. You may not have a withdrawal bleed until the end of the second pack but you may have spotting or breakthrough bleeding on tablet-taking days. Or
Stop taking tablets from your current pack, have a tablet-free break of 7 days or less (also count the day you missed your tablet) and continue with the next pack. When, following this method, you can always start your next pack on the same day of the week as you usually do.
If you have forgotten tablets in a pack and you do not have the expected period in the first normal tablet-free break, you may be pregnant. Consult your doctor before you start with the next pack.
you vomit: If you vomit within 3 to 4 hours after taking your this tablet tablet, the active ingredients may not have been completely absorbed. This is like missing a tablet. Therefore, follow the advice for missed tablets.
you want to delay your period: you can delay your period if you start with your next pack of this tablet immediately after finishing your current pack. You can continue with this pack for as long as you wish, until this pack is empty. When you wish your period to begin, just stop tablet taking. While using the second pack you may have some breakthrough bleeding or spotting on tablet-taking days. Start with your next pack after the usual 7 days tablet free break.
you want to change the starting day of your period: If you take your tablets as directed, you will have your period on about the same day every 4 weeks. If you want to change this, just shorten, (never lengthen) the next tablet- free break. For example, if your period usually starts on a Friday and in future you want it to start on Tuesday (3 days earlier) you should now start your next pack 3 days sooner than you usually do. If you make your tablet-free break very short (e.g. 3 days or less) you may not have bleeding during the break. You may have some breakthrough bleeding or spotting during the use of the next pack.
you have unexpected bleeding: With all Pills, for the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) between your periods. You may need to use sanitary protection, but continue to take your tablets as normal. Irregular vaginal bleeding usually stops once your body has adjusted to the Pill (usually after about 3 tablet-taking cycles). If it continues, becomes heavy or starts again, tell your doctor.
you have missed a period: If you have taken all of your tablets at the right time and you have not vomited or used other medicines then you are very unlikely to be pregnant. Continue to take this tablet as usual.
If you miss your period twice in row, you may be pregnant. Tell your doctor immediately. Do not start the next pack of this tablet until your doctor has checked you are not pregnant.
",,"Preparations containing estrogen/progestogen combinations should not be used in the presence of any of the conditions listed below. If any of the conditions appear for the first time during their use, the product should be stopped immediately.
+
+- Thrombosis (venous or arterial) present or in history (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident)
+- Presence or history of prodromi of a thrombosis (e.g.transient ischaemic attack, angina pectoris)
+- Presence or history of migraine with focal neurological symptoms
+- Diabetes mellitus with vascular involvement
+- Disturbed lipometabolism
+- The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis may also constitute a contraindication
+- Pancreatitis or a history thereof if associated with severe hypertriglyceridemia
+- Presence or history of severe hepatic disease as long as liver function values have not returned to normal
+- Severe renal insufficiency or acute renal failure
+- Presence or history of liver tumours (benign or malignant)
+- Known or suspected malignant conditions of the genital organs or the breasts, if sex steroid-influenced
+- Undiagnosed vaginal bleeding
+- Known or suspected pregnancy
+- Hypersensitivity to any of the components of this tablet.
+
","Like other contraceptives some undesirable effects may have seen with this tablet, these include venous and arterial thromboembolic disorders. The following undesirable effects have been reported in users of COCs and whether this association is causal has not been confirmed: Nausea, abdominal pain, Vomiting, diarrhoea, Weight increased, Fluid retention, Headache, Migraine, Depressed mood, mood altered, Breast pain, breast tenderness, Libido decreased, Breast hypertrophy, Rash, urticaria. In women with hereditary angioedema exogenous estrogens may induce or exacerbate symptoms of angioedema.
","The Pill and Breastfeeding: This tablet is generally not recommended for use during breast feeding. If you wish to take the Pill while breastfeeding, please seek the advice of your doctor.
The Pill and Pregnancy: This tablet must not be used by women who are pregnant or who think they may be pregnant.
","The clinical and epidemiological evidence for estrogen/progestogen combinations like this tablet is predominantly based on experience with COCs in general. Therefore, the following warnings related to the use of COCs apply also to the use of this tablet. Also, increased risk of arterial, venous thrombotic and thromboembolic diseases such as myocardial infarction, deep venous thrombosis, pulmonary embolism and of cerebrovascular accidents. These events occur rarely.
+
+- Cervical cancer
+- Hypertriglyceridemia
+- Blood pressure
+- Jaundice
+- Erythematosus
+- Haemolytic uraemic syndrome
+- Sydenham's chorea
+- Herpes gestationis
+- Otosclerosis-related hearing loss.
+- Hereditary angioedema
+- Acute or chronic disturbances of liver or kidney
+- Crohn's disease and ulcerative colitis
+- Chloasma
+
+
The Pill and other Medicines: Some medicines may stop the Pill from working properly. These include medicines used for the treatment of epilepsy (e.g. primidone, phenyton, barbiturates) and tuberculosis (e.g. rifampicin); and antibiotics (e.g. ampilicllin, tetracyclines, griseofulvin); for some other infectious diseases. Always tell the doctor, who prescribes the Pill, which medicines you are already using. Also tell other doctor/dentist who prescribes another medicine (or the dispensing pharmacist) that you use this tablet. They can tell you if you need to take additional contraceptive precautions and if so, for how long.
The Pill and Ability to Drive: There are no observed effects.
",,,,,"Store below 30°C. Store all drugs properly and keep them out of reach of children.
",10
+1807,Ethinyl Estradiol + Desogestrel + Ferrous Fumarate,ethinyl-estradiol-desogestrel-ferrous-fumarate-1807,,Oral Contraceptive preparations,Oral contraceptives,"Contraception, Oral contraceptives
","Oral Contraceptive preparations
",,,,,,,,,,,,,,2
+332,Ethinyl Estradiol + Desogestrel (0.03 mg),ethinyl-estradiol-desogestrel-003-mg-332,https://medex.com.bd/attachments/7rzpoaR54X6FtHL32iUlGp1pjRB52u/ethinyl-estradiol-desogestrel-003-mg-prescribing-information,Oral Contraceptive preparations,Oral contraceptives,"This is indicated to prevent pregnancy. Oral contraceptives are a very effective method of birth control. When taken correctly (without missing tablets), the chance of becoming pregnant is very low.
","Oral Contraceptive preparations
",,"This pack contains 21 tablets. On the pack, each tablet is marked with the day of the week on which it is to be taken. Take your tablet at about the same time each day, with some water if necessary. Follow the direction of the arrows until all 21 tablets have been taken. During the next 7 days you take no tablets. A period should begin during these 7 days (the withdrawal bleed). Usually, it will start on day 2-3 after the last tablet. Start taking your next pack on the 8th day even if your period continues. This means that you will always start new packs on the same day of the week, and also that you have your withdrawal bleed on about the same days, each month.
Starting your first pack of this tablet-
+
+- When no hormonal contraceptive has been used in the past month: Start taking this tablet on the first day of your cycle, i.e. the first day of menstrual bleeding. Take a tablet marked with that day of the week. For example, if your period starts on a Friday, take a tablet marked Friday. Then follow the day's in order. You may also start on days 2-5 of your cycle, but in that case make sure you also use an additional contraceptive method (barrier method) for the first 7 days of tablet taking in the first cycle.
+- When changing from another combined Pill: You can start taking this tablet the day after you take the last tablet from your present Pill pack (this means no tablet free break). If your present Pill pack also contains inactive tablets you can start this tablet on the day after taking the last active tablet (if you are not sure which this is, ask your doctor or pharmacist). You can also start later, but never later than the day following the tablet-free break of your present Pill (or the day after the last inactive tablet of your present Pill).
+- When changing from a progestagen-only Pill (minipill): You can stop taking the minipill any day and start taking this tablet the next day, at the same time. But make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet taking when having intercourse.
+- When changing from an injectable or implant: Start using this tablet when your next injection is due or on the day that your implant is removed. But make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet-taking when having intercourse.
+- After having a baby: If you have just had a baby, your doctor may tell you to wait until after your first normal period before you start taking this tablet. Sometimes it is possible to start sooner. Your doctor will advise you. If you are breast-feeding and want to take this tablet, you should discuss this first with your doctor.
+- After a miscarriage or an abortion: Your doctor will advise you.
+
+
If too many this tablet are taken (overdose): There have been no reports of serious harmful effects from taking too many this tablets at one time. If you have taken several tablets at a time, you may have nausea, vomiting or vaginal bleeding. If you discover that a child has taken this tablet, ask your doctor for advice.
When you want to stop taking this tablet: You can stop taking this tablet at any time you want. If you do not want to become pregnant, ask your doctor about other methods of birth control.
If you stop taking this tablet because you want to get pregnant, it is generally recommended that you wait until you have had a natural period before trying to conceive. This helps you to work out when the baby will be due.
","If you forget tablets:
+
+- If you are less than 12 hours late in taking a tablet, the reliability of the Pill is maintained. Take the tablet as soon as you remember and take the next tablets at the usual times.
+- If you are more than 12 hours late in taking any tablet, the reliability of the Pill may be reduced. The more consecutive tablets you have missed, the higher the risk that the contraceptive efficacy is decreased. There is a particularly high risk of becoming pregnant if you miss tablets at the beginning or at the end of the pack. Therefore you should follow the rules given below.
+
+More than one tablet forgotten in a pack: Ask your doctor for advice.
1 tablet missed in week 1: Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. Use extra contraceptive precautions (barrier method) for the next 7 days. If you had sexual intercourse in the week before missing the tablets, there is a possibility of becoming pregnant. So tell your doctor immediately.
1 tablet missed in week 2: Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. The reliability of the Pill is maintained. You need not use extra contraceptive precautions.
1 tablet missed in week 3: You may choose either of the following options, without the need for extra contraceptive precautions.
Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. Start the next pack as soon as the current pack is finished so that no gap is left between packs. You may not have a withdrawal bleed until the end of the second pack but you may have spotting or breakthrough bleeding on tablet-taking days. Or
Stop taking tablets from your current pack, have a tabletfree break of 7 days or less (also count the day you
missed your tablet) and continue with the next pack. When following this method, you can always start your next pack on the same day of the week as you usually do.
If you have forgotten tablets in a pack and you do not have the expected period in the first normal tablet-free break, you may be pregnant. Consult your doctor before you start with the next pack.
you vomit: If you vomit within 3 to 4 hours after taking your this tablet, the active ingredients may not have been completely absorbed. This is like missing a tablet. Therefore, follow the advice for missed tablets.
you want to delay your period: you can delay your period if you start with your next pack of this tablet immediately after finishing your current pack. You can continue with this pack for as long as you wish, until this pack is empty. When you wish your period to begin, just stop tablet taking. While using the second pack you may have some breakthrough bleeding or spotting on tablet-taking days. Start with your next pack after the usual 7 day tablet-free break.
you want to change the starting day of your period: If you take your tablets as directed, you will have your period on about the same day every 4 weeks. If you want to change this, just shorten, (never lengthen) the next tablet-free break. For example, if your period usually starts on a Friday and in future you want it to start on Tuesday (3 days earlier) you should now start your next pack 3 days sooner than you usually do. If you make your tablet-free break very short (e.g. 3 days or less) you may not have a bleeding during the break. You may have some breakthrough bleeding or spotting during the use of the next pack.
You have unexpected bleeding: With all Pills, for the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) between your periods. You may need to use sanitary protection, but continue to take your tablets as normal. Irregular vaginal bleeding usually stops once your body has adjusted to the pill (usually after about 3 tablet-taking cycles). If it continues, becomes heavy or starts again, tell your doctor.
you have missed a period: If you have taken all of your tablets at the right time, and you have not vomited, or used other medicines then you are very unlikely to be pregnant. Continue to take this tablet as usual. If you miss your period twice in a row, you may be pregnant. Tell your doctor immediately. Do not start the next pack of this tablet until your doctor has checked you are not pregnant.
",,"Do not use the combined Pill if you have any of the conditions listed below. If any of these apply to you, tell your doctor before starting to use this tablet. Your doctor may advise you to use a different type of Pill or an entirely different (non-hormonal) method of birth control.
+
+- If you have, or have ever had a disorder affecting the blood circulation. In particular, those conditions relating to thrombosis. Thrombosis is the formation of a blood clot. This may occur in the blood vessels of the legs (deep vein thrombosis), the lungs (pulmonary embolism), the heart (heart attack), the brain (stroke), or other parts of the body.
+- If you have or have ever had a condition that may be a first sign of a heart attack (such as angina pectoris or chest pain) or stroke (such as transient ischaemic attack or small reversible stroke).
+- If you have diabetes mellitus with blood vessel damage.
+- If you have jaundice (yellowing of the skin) or severe liver disease.
+- If you have or have had cancer of the breast or the genital organs.
+- If you have or have had a benign or malignant tumour in the liver.
+- If you have any unexplained vaginal bleeding.
+- If you are pregnant or think you might be pregnant.
+- If you are allergic to any of the ingredients of this tablet.
+
+If any of these conditions appear for the first time while using the Pill, stop taking it at once and consult your doctor. In the meantime, use non-hormonal contraceptive measures.
","Possible side effects: The following side effects have been reported by users of the Pill, although they need not be caused by the Pill. These side effects may occur in the first few months that you are using the Pill and usually lessen with time.
+
+- breast tenderness, pain and secretion;
+- headache;
+- changes in sexual drive; depressive moods;
+- contact lens intolerance;
+- nausea, vomiting and feeling sick;
+- changes in vaginal secretion;
+- various skin reactions;
+- fluid retention;
+- changes in body weight;
+- hypersensitivity reactions.
+
","The Pill and Breastfeeding: This tablet is generally not recommended for use during breast feeding. If you wish to take the Pill while breastfeeding, please seek the advice of your doctor.
The Pill and Pregnancy: This tablet must not be used by women who are pregnant, or who think they may be pregnant.
","Before you start to use this tablet: If the combined Pill is used in the presence of any of the conditions listed below you may need to be kept under close observation. Your doctor can explain this to you. Therefore, if any of these apply to you, tell your doctor before starting to use this tablet
+
+- you smoke;
+- you have diabetes;
+- you are overweight;
+- you have high blood pressure;
+- you have a heart valve disorder or a certain heart rhythm disorder;
+- you have an inflammation of your veins (superficial phlebitis);
+- you have varicose veins;
+- anyone in your immediate family has had a thrombosis, a heart attack or a stroke;
+- you suffer from migraine;
+- you suffer from epilepsy;
+- you or someone in your immediate family have or had high blood levels of cholesterol or triglycerides (fatty substances);
+- anyone in your immediate family has had breast cancer;
+- you have liver or gallbladder disease;
+- you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
+- you have systemic lupus eryhematosus (SLE; a disease affecting the skin all over the body);
+- you have haemolytic uraemic syndrome (HUS; a disorder of blood coagulation causing failure of the kidneys);
+- you have sickle cell disease;
+- you have or have had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face): if so, avoid too much exposure to the sun or ultraviolet radiation.
+
+If any of the above conditions appear for the first time, recur or worsen while using the Pill, you should contact your doctor.
The Pill and Thrombosis: A thrombosis is the formation of a blood clot, which may block a blood vessel. A thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis). If this blood clot breaks away from the veins where it is formed, it may reach and block the arteries of the lungs, causing a so-called ""Pulmonary embolism."" Deep venous thrombosis is a rare occurrence. It can develop whether or not you are taking the Pill. It can also happen if you become pregnant. The risk is higher in Pill-users than in non-users, but it is not as high as the risk during pregnancy.
Blood clots can also occur very rarely in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke). Extremely rarely blood clots can occur in the liver, gut, kidney or eye.
Very occasionally a thrombosis may cause serious permanent disabilities or may even be fatal.
The risk of having a heart attack or stroke increases, as you get older. It also increases the more you smoke. When using the Pill you should stop smoking, especially if you are older than about 35 years of age.
If you develop high blood pressure while using the Pill, you may be told to stop using it.
The risk of having a deep venous thrombosis is temporarily increased as a result of an operation or immobilisation (for example, when you have your leg or legs in plaster or splints). In women who use the Pill, the risk may be yet higher. Tell your doctor you are using the Pill well in advance of any expected hospitalisation or surgery. Your doctor may tell you to stop taking the Pill several weeks before surgery or at the time of immobilisation. Your doctor will also tell you when you can start taking the Pill again after you are back on your feet. If you notice possible signs of a thrombosis, stop taking the Pill and consult your doctor immediately.
The Pill and cancer: Breast cancer has been diagnosed, slightly more often in women who use the Pill than in women of the same age who do not use the Pill. This slight increase in the numbers of breast cancer diagnoses gradually disappears during the course of the 10 years after stopping use of the Pill. It is not known whether the difference is caused by the Pill. It may be that the women were examined more often, so that the breast cancer was noticed earlier. In rare cases benign liver tumours and even more rarely, malignant liver tumours have been reported in users of the Pill. These tumours may lead to internal bleeding. Contact your doctor immediately if you have severe pain in your stomach.
Cervical cancer has been reported to occur more often in women using the Pill for a long time. This finding may not be caused by the Pill but may be related to sexual behaviour and other factors.
The Pill and other Medicines: Some medicines may stop the Pill from working properly. These include medicines used for the treatment of epilepsy (eg. primidone, phenytoin, barbiturates) and tuberculosis (eg. rifampicin); and antibiotics (eg. ampcillin, tetracyclines, griseofulvin) for some other infectious diseases. Always tell the doctor, who prescribes the Pill, which medicines you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that you use this tablet. They can tell you if you need to take additional contraceptive precautions and if so, for how long.
The Pill and Ability to Drive: There are no observed effects.
",,,,,"Store in a cool & dry place in between 2-25° C, protect from light. Keep out of the reach of children.
",9
+1805,Ethinyl Estradiol + Desogestrel (0.02 mg),ethinyl-estradiol-desogestrel-002-mg-1805,,Oral Contraceptive preparations,Oral contraceptives,"The benefits of taking the pill include:
+
+- It is one of the most reliable reversible methods of contraception if used correctly
+- It does not interrupt sex
+- It usually makes period regular, lighter and less painful
+- It may help with pre-menstrual symptoms
+
","Oral Contraceptive preparations
",,"Take this tablet every day for 21 days as described below: This tablet comes in strips of 21 pills, each marked with a day of the week.
+
+- Take your pill at the same time every day.
+- Start by taking a pill marked with the correct day of the week.
+- Follow the direction of the arrows on the strip. Take one pill each day, until you have finished all 21 pills.
+- Swallow each pill whole, with water if necessary. Do not chew the pill.
+- After you have taken all 21 pills in the strip, you have seven days when you take no pills. So, if you take the last pill of one pack on a Friday, you will take the first pill of your next pack on the Saturday of the following week.
+
+Within a few days of taking the last pill from the strip, you should have a withdrawal bleed like a period. This bleed may not have finished when it is time to start your next strip of pills.
You don't need to use extra contraception during these seven pill-free days.
Starting this tablet:
+
+- As a new user icrolon or starting the pill again after a break. Either take your first pill on the first day of your next period. By starting in this way, you will have contraceptive protection with your first pill.
+- Or if your period has already begun start taking this tablet on day 5 (counting the first day of your period as day 1) whether or not your bleeding has stopped. You must also use extra contraception, such as condoms, until you have taken the first seven pills correctly.
+
","Changing to this pill from another contraceptive Pill-
+
+- If you are currently on a 21-day pill, start taking jUicrolon the next day after the end of the previous strip. You will have contraceptive protection with your first pill but you will not have a bleed until after you finish your first strip of this pill.
+- If you are currently on a 28-day pill, start taking this pill the day after your last active pill. You will have contraceptive protection with your first pill.
+- You will not have a bleed until after you finish your first strip of this pill.
+- Or if you are taking a Progestogen-only Pill (POP), start. This pill on the first day of bleeding, even if you have already taken the POP for that day. You will have contraceptive cover straight away. If you don't usually have any bleeding while you are taking a Progestogen-only Pill, you can stop taking it any day and start this pill the next day. You will need to use extra contraception, such as a condom, for seven days.
+- Changing to this pill from a Progestogen-only injection, implant of Progestogen releasing intrauterine device (IUD). Start taking this pill when your next injection is due or on the day that your implant or IUD is removed. Make sure you also use an additional contraceptive method, such as a condom, for the first 7 days that you are taking this pill.
+
+
Starting this pill after a miscarriage or abortion: If you have had a miscarriage or an abortion, your doctor may tell you to start taking this pill straight away. This means that you will have contraceptive protection with your first pill. Contraception after having a baby if you have just had a baby, ask your doctor for advice about contraception.
If you are not breast-feeding:
+
+- You can start taking this pill three weeks after the birth or more than three weeks after the birth but you need to use extra contraception, such as a condom until you have taken the first seven pills correctly.
+- If you have had sex since birth there is a chance that you could be pregnant, you should therefore use another form of contraception, such as a condom. In this case, take your first this pill on the first day of your next period.
+
+A missed pill:
+
+- If you have missed any of the pills in a strip and you do not bleed in the first pill-free break, you may be pregnant. Contact your doctor or family planning clinic or do a pregnancy test yourself.
+- If you start a new strip of pills late or make your ""week off"" longer than seven days, you may not be protected from pregnancy.
+- If you had sex in the last seven days, ask your doctor, family planning nurse or pharmacist for advice. You may need to consider emergency contraception. You should also use extra contraception, such as a condom, for seven days.
+
+
A lost pill: If you lose a pill, either take the last pill of the strip in place of the lost pill. Then take all the other pills on their proper days. Your cycle will be one day shorter than normal, but your contraceptive protection won't be affected. After your seven pill-free days you will have a new starting day, one day earlier than before.
If you are sick or have diarrhea: If you are sick (vomit) or have very bad diarrhoea your body may not get its usual dose of hormones from that pill. If you vomit within 3 to 4 hours after taking your pill, this is like missing a pill. You must follow the advice for missed pills. If you have severe diarrhoea for more than 12 hours after taking. This pill follow the instructions for if you are more than 12 hours late, A missed pill. Talk to your doctor if your stomach upset carries on or gets worse. He or she may recommend another form of contraception.
Missed a period- could you be pregnant: Occasionally, you may miss a withdrawal bleed. This could mean that you are pregnant, but that is very unlikely if you have taken your pills correctly. Start your next strip at the normal time. If you think that you might have put yourself at risk of pregnancy (for example, by missing pills or taking other medicines), or if you miss a second bleed, you should do a pregnancy test.
Taking more than one pill should not cause harm: It is unlikely that taking more than one pill will do you any harm, but you may feel sick, vomit or have some vaginal bleeding. Talk to your doctor if you have any of these symptoms.
You can delay a period: If you want to delay having a period, finish the strip of pills you are taking. Start the next strip the next day without a break. Take this strip the usual way. After the second strip, leave seven pill-free days as usual, then start your next strip of pills in the normal way. When you use the second strip, you may have some unexpected bleeding or spotting on the days that you take the pill, but don't worry.
When you want to get pregnant: If you are planning a baby, it’s best to use another method of contraception after stopping this pill until you have had a proper period. Your doctor or midwife relies on the date of your last natural period before you get pregnant to tell you when your baby is due. However, it will not cause you or the baby any harm if you get pregnant straight away.
",,"You should not use this tablet if you have or ever had any of the conditions listed below:
+
+- A blood clot in a blood vessel of legs (Deep Vein Thrombosis, DVT), lungs (Pulmonary Embolus, PE) or other organs
+- A disorder affecting blood clotting- for instance, protein C deficiency, protein S deficiency, antithrombin-lll deficiency, Factor V Leiden or antiphospholipid antibodies
+- Need an operation or off to feet for a long time
+- A heart attack or stroke
+- Angina pectoris
+- Any of the following diseases that may increase risk of a clot in the arteries: Severe diabetes with blood vessel damage, Very high blood pressure, A very high level of fat in the blood (cholesterol or triglycerides), A condition known as hyperhomocysteinaemia
+- A type of migraine called ""migraine with aura""
+- Severe liver disease or liver tumour
+- Cancer affected by sex hormones- such as some cancers of the breast, womb lining or ovary
+- Vaginal bleeding that has not been explained by doctor
+- Allergy (hypersensitivity) to any of the ingredients in this tablet
+
+If you suffer from any of these or get them for the first time while taking this tablet contact your doctor as soon as possible stop taking this tablet.
","
+- Migraine or headache (see a doctor as soon as possible if this is your first migraine or it’s worse than usual, or if the headache is severe, unusual or long lasting)
+- Putting on weight or losing weight
+- Breast problems, such as painful or tender breasts; producing a milky fluid from the nipples
+- Depression or mood changes
+- Changes in sexual desire
+- Heart or circulation problems, such as increased blood pressure, swollen hands, ankles or feet (a sign of fluid retention)
+- Changes in vaginal secretions (Irregular vaginal bleeding)
+- Skin problems; such as, rash, bruise-like swelling to the shins (erythema nodosom)
+- Stomach problems; such as, nausea, vomiting
+- Discomfort of the eyes who wears contact lenses
+
","Do not use this tablet if you are pregnant. If you think you might be pregnant, do a pregnancy test to confirm that you are before you stop taking this tablet. This tablet is not recommended for use in breastfeeding. Ask your doctor or family planning nurse about alternative contraception.
","If you ever need to take another medicine at the same time as being on the pill, always tell your doctor, pharmacist or dentist that you're taking this tablet. Also check the leaflets that come with all your medicines to see if they can be taken with hormonal contraceptives.
Some medicines can stop this tablet from working properly-for example:
+
+- Some medicines used to treat epilepsy (Primidone, Phenytoins, Barbiturates, Carbamazepine, Oxcarbazepine, Topiramate, Felbamate)
+- Medicine to treat tuberculosis (Rifampicin)
+- Certain HIV medicines (Ritonavir)
+- Certain antibiotics (Penicillins, Tetracyclines)
+- St. John’s Wort (a herbal remedy)
+- Griseofulvin (an antifungal drug)
+
+If you do need to take one of these medicines, this tablet may not be suitable for you or you may be able to take this tablet and use extra contraception for a while. This tablet can also affect how well other medicines work. For example, Cyclosporine and Lamotrigine.
Taking these medicines with food and drink: There are no special instructions about food and drink while on this tablet.
Bleeding between periods should not last long: A few women have a little unexpected bleeding or spotting while they are taking this pill, especially during the first few months. Normally, this bleeding is nothing to worry about and will stop after a day or two. Keep taking this pill as usual; the problem should disappear after the first few strips. You may also have unexpected bleeding if you are not taking your pills regularly, so try to take your pill at the same time every day. Also, unexpected bleeding can sometimes be caused by other medicines. Make an appointment to see your doctor if you get breakthrough bleeding or spotting that:
+
+- Carries on for more than the first few months
+- Starts after you’ve been taking this pill for a while
+- Carries on even after you’ve stopped taking this pill
+
",,,,,"Store in a cool & dry place, protect from light & moisture. Keep out of the reach of children.
",9
+1456,Ethanol + Isopropyl alcohol,ethanol-isopropyl-alcohol-1456,,Bleaching and Disinfectants,Topical antiseptic,"They are liquids used primarily as a topical antiseptic. They also have multiple industrial and household uses. The term ""rubbing alcohol"" has become a general non-specific term for either isopropyl alcohol (isopropanol) or ethyl alcohol (ethanol) rubbing-alcohol products.
","Bleaching and Disinfectants
","Ethanol and isopropyl alcohol are both members of the alcohol family and have similar disinfectant properties. Ethanol is the type of alcohol present in alcoholic beverages. Isopropyl alcohol is also known as isopropanol, 2-propanol or rubbing alcohol. When used as disinfectants, both are typically at a concentration of 70 percent in water.
","
+- শুকেনা হােতর তালুেত ১-২ বার ক্লিন জেল প্রয়োগ করুন।
+- দুই হােতর তালু একসােথ ভােলাভােব ঘষুন।
+- আঙুেলর মােঝ ও নেখর ভেতরেও প্রয়োগ করুন এবং না শুকােনা পর্যন্ত ঘষুন।
+- কেয়ক সেকেন্ডর মধ্যেই হাত শুিকিয় জীবাণু মুক্ত হয়ে যাবে
+
",,,,,,"শিশুদের নাগােলর বাইের রাখুন ।
",,,,,"আলো ও তাপ থেকে দূরে, ঘরের স্বাভাবিক তপমাত্রায় রাখুন
",6
+438,Ethambutol,ethambutol-438,https://medex.com.bd/attachments/DQTO2wNXwiHS69Mp944JA1l6fYKtlc/ethambutol-prescribing-information,Anti-Tubercular Chemotherapeutics,Tuberculosis,"Ethambutol is indicated for the treatment of pulmonary tuberculosis. It should not be used as the sole antituberculous drug, but should be used in conjunction with at least one other antituberculous drug. Selection of the companion drug should be based on clinical experience, considerations of ... Read more
Ethambutol is indicated for the treatment of pulmonary tuberculosis. It should not be used as the sole antituberculous drug, but should be used in conjunction with at least one other antituberculous drug. Selection of the companion drug should be based on clinical experience, considerations of comparative safety, and appropriate in vitro susceptibility studies. In patients who have not received previous antituberculous therapy, ie, initial treatment, the most frequently used regimens have been the following:
+
+- Ethambutol plus isoniazid
+- Ethambutol plus isoniazid plus streptomycin.
+
+In patients who have received previous antituberculous therapy, mycobacterial resistance to other drugs used in initial therapy is frequent. Consequently, in such retreatment patients, Ethambutol should be combined with at least one of the second line drugs not previously administered to the patient and to which bacterial susceptibility has been indicated by appropriate in vitro studies. Antituberculous drugs used with Ethambutol have included cycloserine, ethionamide, pyrazinamide, viomycin and other drugs. Isoniazid, aminosalicylic acid, and streptomycin have also been used in multiple drug regimens. Alternating drug regimens have also been utilized.
","Anti-Tubercular Chemotherapeutics
","Ethambutol appears to inhibit the synthesis of 1 or more metabolites in susceptible bacteria resulting in impairment of cellular metabolism, arrest of multiplication, and cell death. It is active against susceptible bacteria only when they are undergoing cell division.
","Ethambutol should not be used alone, in initial treatment or in retreatment. Ethambutol should be administered on a once every 24-hour basis only. Absorption is not significantly altered by administration with food. Therapy, in general, should be continued until bacteriological conversion has become permanent and maximal clinical improvement has occurred.
Ethambutol is not recommended for use in pediatric patients under thirteen years of age since safe conditions for use have not been established.
Initial Treatment: In patients who have not received previous antituberculous therapy, administer Ethambutol 15 mg/kg of body weight, as a single oral dose once every 24 hours. In the more recent studies, isoniazid has been administered concurrently in a single, daily, oral dose.
Retreatment: In patients who have received previous antituberculous therapy, administer Ethambutol 25 mg/kg of body weight, as a single oral dose once every 24 hours. Concurrently administer at least one other antituberculous drug to which the organisms have been demonstrated to be susceptible by appropriate in vitro tests. Suitable drugs usually consist of those not previously used in the treatment of the patient. After 60 days of Ethambutol administration, decrease the dose to 15 mg/kg of body weight, and administer as a single oral dose once every 24 hours.
During the period when a patient is on a daily dose of 25 mg/kg, monthly eye examinations are advised.
Renal Impairment: Dose adjustment may be needed as determined by blood levels of ethambutol.
","Should be taken with food.
","Delayed or reduced absorption with aluminium hydroxide.
","Ethambutol is contraindicated in patients who are known to be hypersensitive to this drug. It is also contraindicated in patients with known optic neuritis unless clinical judgment determines that it may be used. Ethambutol is contraindicated in patients who are unable to appreciate and report visual side effects or changes in vision
","Retrobulbar neuritis with reduction in visual acuity, constriction of visual field, central or peripheral scotoma and green-red colour blindness of 1 or both eyes. Reduced renal clearance of urate and may precipitate acute gout. Confusion, disorientation, hallucinations, headache, dizziness, malaise, jaundice or transient liver dysfunction, peripheral neuropathy, thrombocytopenia, pulmonary infiltrates, eosinophilia and GI disturbances (e.g. nausea, vomiting, anorexia, abdominal pain). Rarely, retinal haemorrhage, hypersensitivity reactions including rashes, pruritus, leucopenia, fever, and joint pains.
","Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Patient with ocular defects (e.g. cataracts, recurrent ocular inflammatory conditions, diabetic neuropathy). Renal impairment. Pregnancy and lactation.
",,,,,"Store between 20-25°C. Protect from light, moisture and excessive heat.
",11
+1631,Etanercept,etanercept-1631,https://medex.com.bd/attachments/buVsDUkAUWfLc9StZ8LAqj79jofDPj/etanercept-prescribing-information,Immunosuppressant,Rheumatoid arthritis,"Adults with Rheumatoid Arthritis (RA): Etanercept indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). Etanercept ... Read more
Adults with Rheumatoid Arthritis (RA): Etanercept indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). Etanercept can be initiated in combination with methotrexate (MTX) or used alone for the treatment of active rheumatoid arthritis (RA) in adults when one or more disease modifying antirheumatic drugs (DMARDs), including methotrexate (unless contraindicated), has proved inadequate.
Pediatric patients with Juvenile Idiopathic Arthritis(JIA): Etanercept indicated for the treatment of polyarticular-course juvenile idiopathic arthritis (JIA) in children and adolescents from the age of 2 years when the response to one or more DMARDs has proven inadequate.
Adults with Psoriatic Arthritis (PsA): Etanercept is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (PsA). Etanercept can be used in combination with methotrexate (MTX) in patients who do not respond adequately to MTX alone.
Adults with Ankylosing Spondylitis (AS): Etanerceptis indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS).
Adults with Plaque Psoriasis (PsO): Etanercept is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.
Pediatric patients with Plaque Psoriasis (PsO): Etanercept is indicated for the treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years, who are inadequately controlled by or are intolerant to systemic therapies or phototherapies.
","Immunosuppressant
","Etanercept is a tumor necrosis factor (TNF) blocker. This is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Etanercept is a TNF alpha inhibitor that binds specifically to tumor necrosis factor (TNF) and blocks its interaction with cell surface TNF receptors. TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF are found in the synovial fluid of RA patients. It plays an important role in the inflammatory processes of rheumatoid arthritis (RA), polyarticular-course juvenile rheumatoid arthritis (JRA) and the resulting joint pathology.
","Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis: Patients aged 18 years or older- 50 mg Etanercept per week administered either once weekly (as one subcutaneous injection using a 50 mg syringe or as two 25 mg injections given at the same time) or 25 mg Etanercept twice weekly (72 to 96 hours apart) as a subcutaneous injection. Methotrexate, glucocorticoids, salicylates, nonsteroidal anti- inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with Etanercept in adults. 25 mg once weekly gives a slower response and may be less effective.
Plaque psoriasis: The dose of etanercept is 50 mg syringe once weekly (as one subcutaneous injection using a 50 mg syringe or as two 25 mg injections given at approximately the same time) or 25 mg twice weekly (72 to 96 hours apart) as a subcutaneous injection. Higher responses may be achieved from initial treatment with a dose of 50 mg twice weekly for up to 12 weeks, followed, if necessary, by a dose of 50 mg once weekly or 25 mg twice weekly.
Adult patients may be treated intermittent or continuously based on physician judgment and individual patient needs. Treatment should be discontinued in patients who show no response after 12 weeks. With intermittent use, treatment cycles subsequent to the initial cycle should use a dose of 50 mg once weekly. No dose adjustment is required for elderly and or patient with renal and hepatic impairment. Patient weighs less than 62.5kg should be accurately dosed on an mg/kg basis. Patients weighing 62.5 kg or more may be fixed-dose prefilled syringe.
Juvenile idiopathic arthritis: Children (⩾2 to <18 years): 0.4mg/kg (up to maximum of 25 mg per dose) twice weekly (72 to 96 hours apart). Glucocoticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with etanercept in children. Etanercept has not been studied in children <2 years of age.
Pediatric plaque psoriasis: Children (⩾6 to <18 years): 0.8mg/kg (up to a maximum of 50 mg per dose) once weekly for up to 24 weeks. Treatment should be discontinued in patients who show no response after 12 weeks. If retreatment of etanercept is indicated, the above guidance on treatment duration should be followed. The dose should be 0.8 mg/kg (up to maximum of 50 mg per dose) once weekly.
","Administer etanercept as subcutaneous injections in the thigh, abdomen or upper arm. Given each new injection at least 3 cm from a previous site. Do not use in the area where the skin is tender, bruised, red or hard. The injection should be performed under supervision of qualified healthcare professional. Before injection, single-use prefilled syringe should be allowed to reach room temperature (approximately 15-30 minutes). The needle cover should not be removed while allowing the pre-filled syringe to reach at room temperature. Before disposal of blank PFS, please activate the needle guard to avoid any chance of needle-stick injury.
",,"If any hypersensitivity to etanercept or to any component of the formulation. Incase of sepsis or risk of sepsis. Treatment with etanercept should not be initiated in patients with serious active infections, including chronic or localized infection.
","Very common: Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); injection site reactions (including bleeding, bruising, redness, itching, pain, and swelling). Reactions at the injection site (these do not occur as often after the first month of treatment. Some patients have developed a reaction at an injection site that was used before.
Common: Allergic reactions; fever; itching; antibodies directed against normal tissue (autoantibody formation).
Uncommon: Serious infections (including pneumonia, deep skin infections, joint infections, blood infection, and infections at various sites); low blood platelet count; skin cancer (excluding melanoma); localized swelling of the skin (angio edema); hives (elevated patches of red or pale skin that often itch); eye inflammation; psoriasis (new or worsening); rash; inflammation or scarring of the lungs; inflammation of the blood vessels affecting multiple organs.
","The safe use of etanercept during pregnancy has not been established. Use etanercept during pregnancy only if clearly needed. The safe use of etanercept during lactation has not been established. It is not known whether etanercept is excreted in human milk. Following subcutaneous administration to lactating rats, etanercept was excreted in the milk and detected in the serum of the pups. Because immunoglobulins and many medicinal products can be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue etanercept while nursing.
","Special warning and special precautions for use-
+
+- Allergic reactions
+- Infections/surgery
+- Infections/diabetes
+- Infections/monitoring
+- Tuberculosis
+- Hepatitis-B
+- Hepatitis-C
+- Blood disorders
+- Nervous system and eye disorders
+- Congestive heart failure
+- Cancer
+- Chickenpox
+- Latex
+- Alcohol abuse
+- Wegener's granulomatosis
+- Anti-diabetic medicine
+
",,"The maximum tolerated dose of etanercept has not been established in humans. Single intravenous doses up to 60 mg/m2 have been administered to healthy volunteers in an endotoxemia study without evidence of dose-limiting toxicities. The highest dose level evaluated in rheumatoid arthritis patients has been an intravenous loading dose of 32 mg/m2 followed by subcutaneous doses of 16 mg/m2 (25 mg) administered twice weekly. No dose-limiting toxicities were observed during clinical trials of rheumatoid arthritis patients. There is no known antidote to etanercept.
",,,"Etanercept should be stored in refrigerator at 2-8°C. Do not freeze. Do not shake. Keep away from light. Keep out of reach of children.
",11
+437,Eszopiclone,eszopiclone-437,https://medex.com.bd/attachments/AvujZHYmcbzdLRK5hNEYywQMISS047/eszopiclone-prescribing-information,Miscellaneous sedatives & hypnotics,Insomnia and sleep disturbances,"Eszopiclone is indicated for the treatment of insomnia, including difficulty falling asleep and difficulty maintaining sleep through the night. Eszopiclone is the first sedative approved long-term use
","Miscellaneous sedatives & hypnotics
","Eszopiclone may interact with Gama-aminobutyric acid (GABA) receptor complexes at binding domains located close to or allosterically coupled to benzodiazepine receptors.
","The usual dose to improve or maintain sleep in most adults is 2 or 3 mg. Persons over the age of 65 years usually are treated with 1 or 2 mg. Eszopiclone should be taken immediately before going to bed since the onset of sedation may occur as rapidly as 10 minutes. It should be taken only by individuals who intend to sleep for at least 8 hours since its effects may last up to six hours.
",,"Alcohol (which causes sedation) and drugs that have sedating effects should not be used with Eszopiclone since their sedating effects, when added to those of Eszopiclone, may cause excessive sedation.
","Depression, Severe Chronic Obstructive Lung Disease, Severe Liver Disease, Weakened Patient, Having thoughts of Suicide.
","Eszopiclone is generally well tolerated. However few side effects like fatigue, anorexia, nausea, unpleasant taste in the mouth, mood problems, abdominal pain, dyspepsia, asthenia, nervousness, dizziness and confusion have been reported.
","Pregnancy: Category C. There is no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.
Nursing Mothers: It is not known whether the drug is excreted in breast milk. As many drugs are excreted in breast milk, caution should be exercised when Eszopiclone is administered to a nursing mother.
","Eszopiclone like all sedatives should be taken immediately before bedtime to avoid short-term memory impairment, hallucinations, impaired coordination, dizziness and lightheadedness
",,"There is limited clinical experience with the overdose of Eszopiclone. In clinical trials one case of overdose with up to 36 mg of Eszopiclone has been reported in which the subject fully recovered. Intravenous fluids should be administered as needed & Flumazenil may be useful.
",,,"Store at 25°C.
",11
+1608,Estriol (Vaginal),estriol-vaginal-1608,https://medex.com.bd/attachments/agdMlaDkuXxMFjFRURXFx4RPSpbknE/estriol-vaginal-prescribing-information,Female Sex hormones,Oestrogen deficiency,"Estriol cream is indicated for the defficiency of estrogen. During menopause, the amount of estrogens produced by a woman's body gradually drops. Shortage of estrogens causes the vaginal wall to become thin and dry which leads to painful sexual intercourse. Estriol cream is used to relieve painful sexual ... Read more
Estriol cream is indicated for the defficiency of estrogen. During menopause, the amount of estrogens produced by a woman's body gradually drops. Shortage of estrogens causes the vaginal wall to become thin and dry which leads to painful sexual intercourse. Estriol cream is used to relieve painful sexual intercourse. This is used in postmenopausal women with at least 12 months since their last natural period. If the ovaries are removed surgically (ovariectomy) before menopause, the decrease in estrogen production occurs very abruptly.
","Drugs for Infertility, Drugs for menopausal symptoms: Hormone replacement therapy, Female Sex hormones
","Estriol Cream is a Hormone Replacement Therapy (HRT). It contains the female hormone estriol (an estrogen). During menopause Estriol is used in vagina which is slowly released and absorbed into the surrounding area and into the bloodstream.
Estriol induces the normalization of the vaginal epithelium and thus helps to restore the normal microflora and the physiological pH in the vagina. As a result, it increases the resistance of the vaginal epithelial cells to infection and inflammation. In comparison to other estrogens, estriol is short acting. In the years just before and after the menopause (which can be natural or surgically induced) estriol can be used in the treatment of symptoms and complaints related to estrogen deficiency. Estriol is particularly used in the treatment of urogenital symptoms.
","Estriol cream should be used as per physician's advice. Each dose of cream contains 0.5 mg estriol.
+
+- For vulvo-vaginal complaints associated with menopause: Initially one dose of cream per day for 3 weeks. Later you may only need one dose of cream twice a week.
+- Before surgery: One dose of cream daily 2 weeks before the operation. When having a Pap smear your doctor may recommend a daily application of cream for 7 days.
+
","How to apply the cream:
+
+- Remove cap from the tube, invert it, and use the sharp point to open the tube.
+- Pull the plunger up to the ring. Now attach it to the opening of the tube.
+- Squeeze the tube slowly to fill the applicator to the ring-mark (where the plunger stops).
+- Remove the tube.
+- To apply the cream, lie down; insert the applicator deep into the vagina.
+- Slowly push the plunger all the way in until the applicator is empty
+- After use, pull the plunger out of the barrel beyond the point of resistance and wash both parts in warm, soapy water. Do not use detergents. Rinse well and dry afterwards. Do not put the applicator in hot or boiling water.
+- The applicator can be re-assembled by fully inserting the plunger into the barrel beyond the point where resistance is felt.
+- Discard the applicator once the tube is empty. Take Estriol cream before taking rest or going to sleep.If you forget a dose, use it as soon as you remember. But if you remember your missed dose at the time of your next dose, do not use an extra dose. Do not use a double dose to make up for the missed dose. This may increase the chance of you getting an unwanted side effect.
+
","Interaction is found with Anticoagulants,corticosteroid hormones, succinylcholine, theophyllines, and medicines for epilepsy, medicines for fungal or bacterial infections, viral infections, and herbal preparations containing St John's Wort. As a result irregular bleeding may occur.
","Do not use Estriol cream if:
+
+- You have or have ever had breast cancer, or if you are suspected of having it, ovarian cancer, heart attack, stroke, angina, liver disease , thrombosis, pulmonary embolism, vaginal cancer.
+- You are pregnant or think you may be pregnant
+- You have any unexplained vaginal bleeding, blood clotting disorder, endometrial hyperplasia, porphyria, and various kind of allergic reaction.
+- Jaundice, migraine pain, high blood pressure & breathing problem
+- You have had an allergic reaction to estriol, or any of the other ingredients of estriol
+
","
+- Local irritation or itching of vagina, Swelling and increased tenderness of the breasts, Increased vaginal discharge, Nausea, Fluid retention in the tissues, usually marked by swollen ankles or feet.
+- In most patients these side effects will disappear after the first weeks of treatment. Tell your doctor if vaginal bleeding occurs or if any side effect becomes troublesome or persists.
+- Other side effects which may occur with HRT are benign and malignant hormone-dependent tumors such as endometrial cancer, heart attack and stroke, gall bladder disease, skin problems such as rashes, discoloration or red patches on the skin, various skin diseases with blisters and nodules or bleeding into the skin, venous thromboembolism or deep leg or pelvic venous thrombosis and pulmonary embolism (see Before you use Estriol Cream). Using HRT for several years slightly increases the risk of breast cancer.
+
","This medicine is contraindicated during pregnancy & lactation.
","Patients should keep under doctor’s observation for any Hormone Replacement Therapy (HRT). Same role is applicable for the application of Estriol cream. Doctor will give continuous advice regarding risks & benefts of the drug. But in case of jaundice, sudden high blood pressure, migraine, severe headache or pregnancy, the use of Estriol cream will be stopped immediately. Children’s are not allowed to use Estriol cream.
",,,,,"Store below 25°C. Protect from light and moisture. Keep out of reach of children.
",11
+461,Ferrous Ascorbate + Folic Acid + Zinc Sulfate,ferrous-ascorbate-folic-acid-zinc-sulfate-461,,"Iron, Vitamin & Mineral Combined preparation",Pregnancy,"It is indicated on prophylaxis of iron deficiency especially when inadequate diet calls for supplementary zinc and iron during pregnancy and anemia.
","Iron, Vitamin & Mineral Combined preparation
","Ferrous Ascorbate, Folic Acid & Zinc is a combination of three nutritional supplements. Ferrous Ascorbate is a combination of iron and vitamin C. Iron replenishes the iron stores in your body and corrects iron deficiency anemia. Vitamin C (ascorbate) is added to enhance the absorption of iron in the body. Folic Acid is a form of vitamin B. It plays a vital role in the formation of red blood cells, which carry oxygen throughout the body. It is also essential in pregnancy due to its role in the development of the unborn baby's brain and spinal cord. Zinc is a micromineral that provides nutrition.
","Adult & Elderly: One tablet a day before or after meal (food independent absorption) or as directed by the physician. In more severe cases, two tablets a day may be required as prescribed by the physician.
Pediatric patients: Safety and effectiveness in pediatric patients have not been established.
",,"Iron chelates with tetracycline. Since oral iron products interfere with absorption of oral tetracycline antibiotics, this product should not be taken within two hours of each other. Occasional gastrointestinal discomfort may be minimized by taking with meals. Absorption of iron may be impaired by concurrent administrations of penicillamine and antacid. In patients with renal failure, a risk of zinc accumulation may exist.
","It is contraindicated in patients with haemolytic anaemia and in conditions with increased hypersensitivity to any of its components and increased body iron content.
","Side effects of iron, folic acid and zinc supplementation are mild and transient. These include epigastric pain, nausea, constipation, vomiting, diarrhoea, heart burn, etc. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
","If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, before taking or continuing the drug. Administration in first trimester of pregnancy should be avoided unless definite evidence of iron deficiency is observed. Prophylaxis of iron deficiency is justified during the remainder of pregnancy specifically when zinc supplementation is required.
","Care should be taken in patients who may develop iron overload, such as those with haemochromatosis, haemolytic anemia or red cell aplasia. Failure to respond to treatment may indicate other causes of anemia and should be further investigated.
",,"The clinical course of acute iron overdosage can be variable. Initial symptoms may include abdominal pain, nausea, vomiting, diarrhoea, tarry stools, melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+460,Ferrous Ascorbate,ferrous-ascorbate-460,,Oral Iron preparations,Iron deficiency,"Ferrous Ascorbate is indicated in the treatment of iron deficiency anemia.
","Oral Iron preparations
","Ferrous ascorbate, a synthetic molecule of ascorbic acid and iron. Iron replenishes the iron stores in your body and corrects iron deficiency anemia. Vitamin C (ascorbate) is added to enhance the absorption of iron in the body.
","Adult & Elderly: One tablet a day before or after meal (food independent absorption) or as directed by the physician. In more severe cases, two tablets a day may be required as prescribed by the physician.
Pediatric patients: Safety and effectiveness in pediatric patients have not been established.
",,,"It is contraindicated in hemosiderosis, hemochromatosis, hemolytic anemia.
","The treatment of a neurotic patient was interrupted because of nausea and regurgitation. In pregnant women, the incidence of pyrosis and chronic constipation is slightly increased.
",,"Oral iron preparations may aggravate existing peptic ulcer, regional enteritis and ulcerative colitis. Iron compounds taken orally can impair the absorption of tetracycline antibiotics. Antacids given concomitantly with iron compounds decrease iron absorption.
",,"The chance of poisoning is rare in adults with iron overdose.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+1508,Ferric Pyrophosphate Citrate,ferric-pyrophosphate-citrate-1508,https://medex.com.bd/attachments/abGC7CvufutKgzuWdM62E9ir6eQcHR/ferric-pyrophosphate-citrate-prescribing-information,Parenteral Iron Preparations,Iron deficiency,"Ferric Pyrophosphate Citrate is indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).
","Parenteral Iron Preparations
",,"Inspect Ferric Pyrophosphate Citrate ampoule for signs of precipitation prior to mixing with the bicarbonate concentrate. Ferric Pyrophosphate Citrate should only be added to the bicarbonate concentrate and should not be added to acid concentrate mixtures. Add Ferric Pyrophosphate Citrate to bicarbonate concentrate used for generation of hemodialysate. The final concentration of iron (III) in the final hemodialysate is 2 micromolar (110 mcg/L). Multiple ampoules can be added to the master bicarbonate mix at each center at a ratio of one ampoule to each 2.5 gallons of bicarbonate concentrate.
Administer Ferric Pyrophosphate Citrate to patients at each dialysis procedure for as long as patients are receiving maintenance hemodialysis therapy for CKD.
Hemodialysis solutions should be used within 24 hours of the preparation of the Ferric Pyrophosphate Citrate /bicarbonate concentrate mixture.
",,"Formal drug interaction studies have not been performed for Ferric Pyrophosphate Citrate.
",,"The most common side effects are headache, peripheral edema, asthenia, AV fistula thrombosis, urinary tract infection, AV fistula site hemorrhage, pyrexia, fatigue, hypotension, muscle spasms, pain in extremity, back pain, and dyspnea.
","Pregnant women Category C. Lactating mothers It is not known whether Ferric Pyrophosphate Citrate is present in human milk or not.
","Hypersensitivity Reactions: Anaphylactic-type reactions, shock, hypotension, loss of consciousness and collapse can occur. Monitor patients for signs and symptoms of hypersensitivity during and after hemodialysis until he/she is clinically stable. Personnel and therapies should be immediately available for the treatment of serious hypersensitivity reactions.
Iron laboratory testing: Iron status should be determined on pre-dialysis blood samples. Post dialysis serum iron parameters may overestimate serum iron and transferrin saturation.
",,"No data are available regarding overdose of Ferric Pyrophosphate Citrate.
",,,"Keep in a cool and dry place, away from light. Keep out of reach of children.
",9
+1879,Ferric Derisomaltose,ferric-derisomaltose-1879,https://medex.com.bd/attachments/p49iycTlVAopWEBzkbcqTeSYw0ddV8/ferric-derisomaltose-prescribing-information,Parenteral Iron Preparations,Iron deficiency,"Ferric Derisomaltose is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients:
+
+- who have intolerance to oral iron or have had unsatisfactory response to oral iron.
+- who have non-hemodialysis dependent chronic kidney disease.
+
","Parenteral Iron Preparations
","This is an iron replacement product containing ferric derisomaltose for intravenous infusion. Ferric derisomaltose is an iron carbohydrate complex with a matrix structure composed of interchanging layers of ferric hydroxide and the carbohydrate derisomaltose. Derisomaltose consists of linear, hydrogenated isomaltooligosaccharides with an average molecular weight of 1000 Da and a narrow molecular weight distribution that is almost devoid of mono- and disaccharides. Ferric derisomaltose is a complex of iron (III) hydroxide and derisomaltose, an iron carbohydrate oligosaccharide that releases iron. Iron binds to transferrin for transport to erythroid precursor cells to be incorporated into hemoglobin.
","For patients weighing 50 kg or more: Administer 1,000 mg of Ferric Derisomaltose by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs.
For patients weighing less than 50 kg: Administer Ferric Derisomaltose as 20 mg/kg actual body weight by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs.
The dosage of Ferric Derisomaltose is expressed in mg of elemental iron. Each mL of Ferric Derisomaltose contains 100 mg of elemental iron. Only administer Ferric Derisomaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions
","Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Ferric Derisomaltose is single-dose only. Discard unused portion.
+
+- Withdraw the appropriate volume of Ferric Derisomaltose and dilute in 100 mL to 500 mL of 0.9% Sodium Chloride Injection, USP.
+- Final diluted concentration should be more than 1 mg iron/mL.
+- Compatibility of Ferric Derisomaltose with other drugs has not been established. Ferric Derisomaltose should not be mixed with or physically added to solutions containing other drugs.
+- Administer the prepared solution via intravenous infusion over at least 20 minutes.
+- Following dilution with 0.9% Sodium Chloride Injection, USP, Ferric Derisomaltose solution may be stored at room temperature for up to 8 hours.
+- Extravasation of Ferric Derisomaltose may cause brown discoloration at the extravasation site which may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Ferric Derisomaltose administration at that site.
+
",,"Ferric Derisomaltose is contraindicated in patients with a history of serious hypersensitivity to Ferric Derisomaltose or any of its components. Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse.
","Most commonly reported adverse reactions (incidence ≥1%) are rash and nausea.
","There are no available data on Ferric Derisomaltose use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Published studies on the use of intravenous iron products in pregnant women have not reported an association with adverse developmental outcomes. However, these studies cannot establish or exclude the absence of any drug-related risk during pregnancy because the studies were not designed to assess for the risk of major birth defects.
The available data on the use of Ferric Derisomaltose in lactating women demonstrate that iron is present in breast milk. However, the data do not inform the potential exposure of iron for the breastfed child or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Ferric Derisomaltose in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.
","Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferric Derisomaltose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Ferric Derisomaltose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferric Derisomaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Ferric Derisomaltose is contraindicated in patients with prior serious hypersensitivity reactions to Ferric Derisomaltose or any of its components. In clinical trials in patients with IDA and CKD, serious or severe hypersensitivity were reported in 0.3% (6/2008) of the Ferric Derisomaltose treated subjects. These included 3 events of hypersensitivity in 3 patients; 2 events of infusion-related reactions in 2 patients and 1 event of asthma in one patient.
Iron Overload: Excessive therapy with parenteral iron can lead to excess iron storage and possibly iatrogenic hemosiderosis or hemochromatosis. Monitor the hematologic response (hemoglobin and hematocrit) and iron parameters (serum ferritin and transferrin saturation) during parenteral iron therapy. Do not administer Ferric Derisomaltose to patients with iron overload
","Pediatric Use: Safety and effectiveness have not been established in pediatric patients.
","Excessive dosages of Ferric Derisomaltose may lead to the accumulation of iron in storage sites potentially leading to hemosiderosis and hemochromatosis. Avoid use of Ferric Derisomaltose in patients with iron overload.
",,,"Store at 20° to 25°C; excursions permitted to 15° to 30°C. Do not freeze.
",12
+1606,Ferric Citrate,ferric-citrate-1606,https://medex.com.bd/attachments/yzjJjbqCOx0vkMmwnN3Erf809FJLhW/ferric-citrate-prescribing-information,Oral Iron preparations,Iron deficiency,"Ferric Citrate is a phosphate binder indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. Ferric Citrate is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis.
","Oral Iron preparations
","Hyperphosphatemia in chronic kidney disease on dialysis: Ferric iron binds dietary phosphate in the GI tract and precipitates as ferric phosphate. This compound is insoluble and is excreted in the stool. By binding phosphate in the GI tract and decreasing absorption, ferric citrate lowers the phosphate concentration in the serum.
Iron deficiency anemia in chronic kidney disease not on dialysis: Ferric iron is reduced from the ferric to the ferrous form by ferric reductase in the GI tract. After transport through the enterocytes into the blood, oxidized ferric iron circulates bound to the plasma protein transferrin, and can be incorporated into hemoglobin.
","Hyperphosphatemia in chronic kidney disease on dialysis:
+
+- Starting dose is 2 tablets orally 3 times per day with meals.
+- Adjust dose by 1 to 2 tablets as needed to maintain serumphosphorus at target levels, up to a maximum of 12 tablets daily. Dose can be titrated at 1-week or longer intervals.
+
+Iron deficiency anemia in chronic kidney disease not on dialysis:
+
+- Starting dose is 1 tablet orally 3 times per day with meals.
+- Adjust dose as needed to achieve and maintain hemoglobin goal, up to a maximum of 12 tablets daily.
+
",,"When clinically significant drug interactions are expected, consider separation of the timing of administration. Consider monitoring clinical responses or blood levels of the concomitant medication.
","Ferric Citrate is contraindicated in patients with iron overload syndromes.
","Most common adverse reactions (incidence ≥5%) are discolored feces, diarrhea, constipation, nausea, vomiting, cough, abdominal pain, and hyperkalemia.
","There are no available data on Ferric Citrate use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. There are no human data regarding the effect of Ferric Citrate in human milk, the effects on the breastfed child, or the effects on milk production.
","Iron absorption from Ferric Citrate may lead to excessive elevations in iron stores. Increases in serum ferritin and transferrin saturation (TSAT) levels were observed in clinical trials. In a 56-week safety and efficacy trial evaluating the control of serum phosphate levels in patients with chronic kidney disease on dialysis in which concomitant use of intravenous iron was permitted, 55 (19%) of patients treated with Ferric Citrate had a ferritin level >1500 ng/mL as compared with 13 (9%) of patients treated with active control. Assess iron parameters (e.g., serum ferritin and TSAT) prior to initiating Ferric Citrate and monitor iron parameters while on therapy. Patients receiving intravenous iron may require a reduction in dose or discontinuation of intravenous iron therapy.
","Pediatric Use: The safety and efficacy of Ferric Citrate have not been established in pediatric patients.
Geriatric Use: Clinical studies of Ferric Citrate included 292 subjects aged 65 years and older (104 subjects aged 75 years and older). Overall, the clinical study experience has not identified any obvious differences in responses between the elderly and younger patients in the tolerability or efficacy of Ferric Citrate.
","No data are available regarding overdose of Ferric Citrate in patients. In patients with chronic kidney disease, the maximum dose studied was 2,520 mg ferric iron (12 tablets of Ferric Citrate) per day. Iron absorption from Ferric Citrate may lead to excessive elevations in iron stores, especially when concomitant intravenous iron is used.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+459,Ferric Carboxymaltose,ferric-carboxymaltose-459,https://medex.com.bd/attachments/lhVHyNqZMAskSHArHGlL765SLxKNVg/ferric-carboxymaltose-prescribing-information,Parenteral Iron Preparations,Iron deficiency anemia,"Ferric Carboxymaltose is indicated for the treatment of iron deficiency anemia in adult patients-
+
+- Who have intolerance to oral iron or have had unsatisfactory response to oral iron
+- Who have non-dialysis dependent chronic kidney disease.
+
","Parenteral Iron Preparations
","Non-dextran, IV is a colloidal iron hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron; replaces iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin Macrophage engulf FCM from blood and control iron release. Transferrin saturates and, Iron into the liver, spleen and Bone marrow.
","For patients weighing 50 kg or more: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course.
For patients weighing less than 50 kg: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course.
The dosage of Ferric Carboxymaltose is expressed in mg of elemental iron. Each mL of Ferric Carboxymaltose contains 50 mg of elemental iron. Ferric Carboxymaltose treatment may be repeated if iron deficiency anemia reoccurs.
Administer Ferric Carboxymaltose intravenously, either as an undiluted slow intravenous push or by infusion. When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. When administered via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes.
When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Ferric Carboxymaltose solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL.
Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Ferric Carboxymaltose is intended for single use only. Any unused drug remaining after injection must be discarded.
Avoid extravasation of Ferric Carboxymaltose since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Ferric Carboxymaltose administration at that site.
",,"There are no known drug interactions and none well documented.
","Hypersensitivity to any of its components.
","Nausea, Hypertension, Flushing, Decreased blood phosphorus, Dizziness, Vomiting, Pruritus, Rash, Urticaria, Wheezing, Injection site discoloration, Headache, Increased alanine aminotransferase), Dysgeusia, Hypotension, Constipation, Serious anaphylactic/anaphylactoid reactions
","Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferric carboxymaltose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Ferric carboxymaltose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferric carboxymaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but not limited to, pruritus, rash, urticaria, wheezing, or hypotension may occur.
Hypertension: Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Ferric carboxymaltose administration.
",,,,,"Do not store above 30°C. Do not freeze.
",10
+1584,Fenticonazole Nitrate [Vaginal Tablet],fenticonazole-nitrate-vaginal-tablet-1584,,Topical Antifungal preparations,Vulvovaginal candidiasis,"Fenticonazole Nitrate vaginal tablet is indicated for:
+
+- Genital candidiasis (vulvovaginitis, colpitis, infectious fluor)
+- Trichomonasis
+- Vaginal infections sustained by mixed forms of Trichomonas vaginalis and Candida albicans.
+
","Topical Antifungal preparations
","Fenticonazole is a potent broad-spectrum antimycotic agent. It exerts fungistatic and fungicidal actions on dermatophytes, pathogenic yeasts, dimorphous fungi and molds. In addition, Fenticonazole is active against gram-positive bacteria and is therefore indicated in mycoses associated with bacterial super infections. Fenticonazole is also active, both in vitro and in vivo, against Trichomonas vaginalis. Fenticonazole exerts its unique antimycotic action through following three ways:
+
+- Inhibiting the biosynthesis of ergosterol leading to the damage of fungal cell membrane.
+- Causing certain changes in oxidative and peroxidative enzyme activities inside fungal cell. This leads to an intracellular build-up of toxic concentrations of hydrogen peroxide resulting in cell necrosis.
+- Inhibiting the secretion of aspartic proteases (responsible for pathogenicity) by Candida albicans.
+
+The amount of Fenticonazole absorbed by the transcutaneous route is negligible.
","Trichomonas or mixed (Trichomonas and Candida albicans) vaginal infections: One 600 mg VT (followed by a second administration 24 hours later, if necessary).
Candida albicans infections: One single 600 mg VT administration in the evening. Should the symptoms persist, a second administration may be repeated after three days. The tablet must be introduced deep into the vagina and pushed well up to the fornix. To avoid re-infection, it is recommended that the partner undergoes concurrent treatment with Fenticonazole Cream or similar Azole Cream.
",,,"Contraindicated in case of hypersensitivity to Fenticonazole and other Imidazoles.
","After intravaginal administration slight transient burning (which usually disappears rapidly) may occasionally happen. Prolonged topical application may cause sensitisation reactions. Fenticonazole is generally well tolerated by the mucous membranes; only exceptionally mild and transient erythematous reactions have been reported. After topical application or intravaginal administration, a slight burning sensation may occur, usually subsiding soon. Should more persistent irritation occur or resistant micro-organism develop, suspend the treatment and seek the doctor's advice. Due to poor absorption of Fenticonazole, no systemic effects should occur, provided the above instructions are carefully observed.
","It is not recommended in pregnancy. Safety in breastfeeding has not been established.
",,"Fenticonazole Nitrate is not recommended for children.
","As systemic absorption is very low, the possibility of overdose is rare. In case of accidental swallowing, emesis or gastric lavage should be done. After vomiting, active charcoal along with water/lemon juice and laxative should be given to the patient.
",,,"Store below 25°C. Protect from light & moisture.
",10
+458,Fenticonazole Nitrate [Vaginal Cream],fenticonazole-nitrate-vaginal-cream-458,https://medex.com.bd/attachments/ukFcofaTbxkZ5foc6m7FSu5ri2HRIi/fenticonazole-nitrate-vaginal-cream-vaginal-cream-prescribing-information,Topical Antifungal preparations,Vulvovaginal candidiasis,"Fenticonazole Nitrate is used for the treatment of vulvovaginal candidiasis.
","Topical Antifungal preparations
","Fenticonazole is a broad-spectrum antimycotic agent with activity against dermatophytes and yeasts. Fenticonazole has also been shown to exhibit antibacterial action, with a spectrum of activity that includes bacteria commonly associated with vaginal infections and antiparasitic action against the protozoan Trichomonas vaginalis. Therefore, Fenticonazole may be an ideal topical alternative to multi-agent treatment of mixed infections involving mycotic, bacterial, dermatophyte and/or Trichomonas spp.
","Route of application is intravaginal. For adults, one applicator full (about 5 gm) is to be administered into the vagina in the morning and evening for three days.
After each application, clean it carefully with warm water and soap. Do not use water which is hotter than 50°C or solvents. Then wipe the applicator and store in its packet. Always wash your hands with mild soap and warm water afterwards. Fenticonazole is not greasy and can easily be removed with water.
","Follow the instructions to use Fenticonazole cream-
+
+- Screw the applicator onto the tube in place of the cap.
+- Squeeze the tube gently at its lower end, so as to fill the applicator at 5 gm mark. Unless prescribed by the physician, the applicator must be completely filled up to 5 gm.
+- After taking measured amount cream, remove the applicator from the tube, which should be closed immediately with the cap.
+- In a lying down position, with knees raised and spread apart, delicately insert the applicator into the vagina as deeply as possible. Push the piston to penetrate cream completely, then pull out the applicator without touching the piston.
+
","Not investigated. Since systemic absorption of Fenticonazole after application is low, interactions with other drugs are unlikely.
","Hypersensitivity to Fenticonazole or any component of the formulation.
","After intravaginal administration, slight transient burning may occasionally occur, which usually disappears rapidly.
","Since there is no data of use during pregnancy or lactation, So Fenticonazole should not be used without physician's advice.
","It should not be used in conjunction with barrier contraceptives. In the event of a hypersensitivity reaction or development of resistant organisms, treatment should be discontinued and take physician consultation.
","The use of Fenticonazole vaginal cream in children is not recommended.
","Because of the low systemic absorption after vaginal application, overdosage is unlikely.
",,,"Protect from light & moisture. Keep below 30° C temperature, protected from light & moisture. Do not freeze. Keep out of the reach of children.
",13
+455,Fentanyl Citrate,fentanyl-citrate-455,https://medex.com.bd/attachments/IXpdRHCdJjy9cH9M6b7xCg2YJudUse/fentanyl-citrate-injection-prescribing-information,Opioid analgesics,Relieve pain,"Fentanyl is indicated for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg of oral morphine/day, at least ... Read more
Fentanyl is indicated for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg of oral morphine/day, at least 25 mcg of transdermal Fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
","Opioid analgesics
","Fentanyl is an opioid analgesic. Fentanyl interacts predominately with the opioid mu-receptor but also binds to kappa and delta-type opioid receptors. These mu-binding sites are discretely distributed in the human brain, spinal cord, and other tissues. In clinical settings, Fentanyl exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation. Fentanyl may increase the patient's tolerance for pain and decrease the perception of suffering, although the presence of the pain itself may still be recognized. In addition to analgesia, alterations in mood, euphoria and dysphoria, and drowsiness commonly occur. Fentanyl depresses the respiratory centers, depresses the cough reflex, and constricts the pupils.
","Oral-
+
+- Starting Dose: The initial dose of Fentanyl should be 100 mcg.
+- Re-dosing patients within a single episode: Dosing may be repeated once during a single episode of breakthrough pain if pain is not adequately relieved by one Fentanyl dose. Re-dosing may occur 30 minutes after the start of administration of Fentanyl and the same dosage strength should be used.
+- Increasing the dose: Titration should be initiated using multiples of the 100 mcg Fentanyl tablet. Patients require to titrate above 100 mcg can be instructed to use two 100 mcg tablets (one on each side of the mouth in the buccal cavity). If this dose is not successful in controlling the breakthrough pain episode, the patient may be instructed to place two 100 mcg tablets on each side of the mouth in the buccal cavity (total of four 100 mcg tablets). Titrate above 400 mcg by 200 mcg increments bearing in mind using more than 4 tablets simultaneously has not been studied and it is important to minimize the number of strengths available to patients at any time to prevent confusion and possible overdose. To reduce the risk of overdose during titration, patients should have only one strength of Fentanyl tablet available at any one time.
+- Dosage Adjustment: Generally, the dose of Fentanyl should be increased when patients require more than one dose per breakthrough pain episode for several consecutive episodes.
+
+
Injection-
+
+- Fentanyl injection can be administered intravenously either as a bolus or by infusion & by intramuscular route also. The dose of fentanyl should be individualized according to age, body weight, physical status, underlying pathological condition, use of other drugs and type of surgery and anesthesia.
+
+
+- Doses in excess of 200mcg are for use in anesthesia only. As a premedicant, 1-2 ml fentanyl may be given intramuscularly 45 minutes before induction of anesthesia. After IV administration in unpremedicated adult patients, 2ml fentanyl may be expected to provide sufficient analgesia for 10-20 minutes in surgical procedures involving low pain intensity. 10 ml fentanyl injected as a bolus gives analgesia lasting about one hour. The analgesia produced is sufficient for surgery involving moderately painful procedures. Giving a dose of 50mcglkg fentanyl will provide intense analgesia for some four to six hours, for intensely stimulating surgery.
+
+
+- Fentanyl may also be given as an infusion. In ventilated patients, a loading dose of fentanyl may be given as a fast infusion of approximately 1 mcg/kg/min for the first 10 minutes followed by an infusion of approximately 0.1 mcg/kg/min. Alternatively the loading dose of fentanyl may be given as a bolus. Infusion rates should be titrated to individual patient response; lower infusion rates may be adequate. Unless it is planned to ventilate post operatively, the infusion should be terminated at about 40 minutes before the end of surgery.
+
+
+- Lower infusion rates, e.g. 0.05-0.08 mcg/kg/min. are necessary if spontaneous ventilation .is to be maintained. Higher infusion rates (up to 3 mcg/kg/min) have been used in cardiac surgery. Fentanyl is chemically incompatible with the induction agents thiopentone & methohexitone because of wide differences in pH
+
+
+- Use in elderly and debilitated patients: It is wise to reduce the dosage in the elderly and debilitated patients. The effect of the initial dose should be taken into account in determining supplemental doses.
+
+
Transdermal-Intractable chronic pain:
+
+- Adult: Patches deliver fentanyl in doses that range from: 12-100 mcg/hr. Doses should be individually titrated based on previous use of opioids. Opioid-naive patients: Initially, ≤25 mcg/hr; it is recommended to initially titrate w/ low doses of short-acting opioids before starting fentanyl patches. Patients receiving a strong opioid analgesic: Initial dose should be based on the previous 24-hr opioid requirements. During transfer to fentanyl patches, previous opioid treatment should be phased out gradually. If patient requires doses >100 mcg/hr, >1 patch may be used; consider alternative or additional therapy if doses >300 mcg/hr are required. Replace patch every 72 hr and apply the new patch to a different site; avoid using the same area of skin for a few days.
+- Elderly: Dose reduction may be needed.
+
","Tablet Administration: Patients should remove the tablet from the blister strip and immediately place the entire tablet in the buccal cavity (above a rear molar, between the upper cheek and gum). Patients should not attempt to split the tablet. The tablet should not be chewed or swallowed, as this will result in lower plasma concentrations than when taken as directed. The tablet should be left between the cheek and gum until it has disintegrated, which usually takes approximately 14-25 minutes. After 30 minutes, if remnants from the tablet remain, they may be swallowed with a glass of water.
","Co-administration of different antifungals, macrolide antibiotics, CNS depressant drugs like ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, and nefazadone may enhance or prolong the effects of Fentanyl. The concomitant use of amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil with Fentanyl may also result in an increase in Fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression.
","Fentanyl is contraindicated in the management of acute or postoperative pain. This product must not be used in opioid non-tolerant patients. Fentanyl is contraindicated in patients with known intolerance or hypersensitivity to any of its components or the drug Fentanyl.
","As with other narcotic analgesics, the most common serious adverse reactions reported to occur with Fentanyl are respiratory depression, apnoea, muscular rigidity, myoclonic movements, and bradycardia. Respiratory depression is more likely to occur with intravenous administration if a dose is given too rapidly and it rarely occurs with intramuscular administration.
","Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Fentanyl should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Fentanyl is excreted in human milk; therefore Fentanyl should not be used in nursing women because of the possibility of sedation and/or respiratory depression in their infants.
","Opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g. driving a car or operating machinery). Patients taking Fentanyl should be warned of these dangers and should be counseled accordingly. The use of concomitant CNS active drugs requires special patient care and observation.
Chronic pulmonary disease: Fentanyl should be titrated with caution in patients with chronic obstructive pulmonary disease or pre-existing medical conditions predisposing them to respiratory depression.
Head injuries and increased intracranial pressure: Opioids may obscure the clinical course of a patient with a head injury and should be used only if clinically warranted.
Cardiac disease: Intravenous Fentanyl may produce bradycardia. Therefore, Fentanyl should be used with caution in patients with bradyarrhythmias.
Hepatic or renal disease: Fentanyl should be used with caution because of the hepatic metabolism and renal excretion of Fentanyl.
",,"In insufficient overdosage, Fentanyl would produce narcosis, marked skeletal muscle rigidity. Cardio-respiratory depression and cyanosis may also occur. In the presence of hypoventilation or apnoea, oxygen should be administered and respiration should be assisted. A specific narcotic antagonist, such as naloxane, should be available for use as indicated to manage respiratory depression.
",,,"Store between 20-25°C. Protect from light.
",12
+454,Fenofibrate,fenofibrate-454,https://medex.com.bd/attachments/u99tvQGLCTfeEKW7ZF660fM0fCCXHy/fenofibrate-prescribing-information,Fibrates,Hypertriglyceridaemia,"Fenofibrate is indicated for hyperlipidemias of type lla, llb, III, IV & V in patients who have not responded adequately to diet & other appropriate measures.
","Fibrates
","Fenofibrate is a fibric acid derivative. Fenofibrate is rapidly hydrolyzed after oral ingestion to its pharmacologically active form, fenofibric acid. Fenofibric acid produces reductions in total cholesterol, LDL cholesterol, Apo-lipoprotein B, Total triglycerides and VLDL. In addition, treatment with Fenofibrate results in increases in HDL and apo-proteins apoAI apoAII. Fenofibrate also reduces serum uric acid levels in hyperuricemic and normal individuals by increasing the urinary excretion of uric acid. The micronised form of Nofiate (Fenofibrate) has enhanced absorption over the non-micronised formulation.
","
+- For the treatment of adult patients with hypercholesterolemia or mixed hyperlipidemia, the initial dose of Fenofibrate is 200 mg per day.
+- For adult patients with hypertriglyceridemia, the initial dose is 67 to 200 mg per day.
+- Dose should be individualized according to patient response. Fenofibrate should be given with meal there by, optimizing the bioavailability of the medication. Or, as directed by the registered physician.
+
",,"Fenofibrate has been reported to potentiate the anticoagulant effects of warfarin. When administered with antidiabetic drug it may improve glucose tolerance and have additive effect. Fenofibrate may also increase the nephrotoxicity of cyclosporine. Due to a potential increase in the risk of rhabdomyolysis, cautions should be taken against the use of Fenofibrate with HMG-CoA reductase inhibitors. However, the use of low-dose statins with Fenofibrate appears to be well tolerated.
","Fenofibrate is contraindicated in patients with hypersensitivity to Fenofibrate, severe renal or hepatic impairment, existing gall bladder disease, breast feeding mothers, photosensitivity to ketoprofen.
","Gastro-intestinal (e.g. nausea, anorexia, gastric pain), pruritus, urticaria, impotence, also headache, dizziness, vertigo, fatigue, hair loss; myotoxicity.
","Fenofibrate is not recommended for pregnant women.
","Special care needed in patients with renal disease, as progressive increases in serum creatinine concentration or failure to follow dosage guidelines may result in myotoxicity; discontinue if myotoxicity suspected or creatinine kinase concentration increases significantly. Liver function tests recommended every 3 months for first year.
",,"There is no specific treatment for overdose with Fenofibrate. General supportive care of the patients is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. Because Fenofibrate is highly bound to plasma proteins, hemodialysis should not be considered.
",,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",11
+453,Febuxostat,febuxostat-453,https://medex.com.bd/attachments/QN26w61w3nBhWXlTbaekvvl5SwKgqr/febuxostat-prescribing-information,Drugs used in Gout,Uric acid nephropathy,"Febuxostat is indicated for the chronic management of hyperuricemia in patients with gout. Febuxostat is not recommended for the treatment of asymptomatic hyperuricemia.
","Drugs used in Gout
","Febuxostat is a non-purine, selective xanthine oxidase (XO) inhibitor. It decreases serum uric acid level by inhibiting xanthine oxidase, which is responsible for uric acid production. Xanthine oxidase breaks down hypoxanthine to xanthine and thus to uric acid. Febuxostat is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations.
","Febuxostat is recommended at 40 mg or 80 mg once daily. The recommended starting dose of Febuxostat is 40 mg once daily. For patients who do not achieve a serum uric acid less than 6 mg /dL after 2 weeks with 40 mg, Febuxostat 80 mg is recommended. Febuxostat can be administered without regard to food or antacid use. No dose adjustment is necessary when administering Febuxostat to patients with mild to moderate renal or hepatic impairment.
",,"Concomitant administration of Febuxostat with azathioprine, mercaptopurine or theophylline could increase plasma concentrations of these drugs resulting in severe toxicity.
","Febuxostat is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline.
","The most common adverse events associated with the use of Febuxostat may include liver function abnormalities, nausea, arthralgia, and rash.
","Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Febuxostat should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Caution should be exercised when Febuxostat is administered to a nursing woman.
","Gout Flare: An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including Febuxostat. If a gout flare occurs during treatment, Febuxostat need not be discontinued. Prophylactic therapy (i.e., non-steroidal anti-inflammatory drug (NSAID) or colchicine upon initiation of treatment) may be beneficial for up to six months.
Cardiovascular Events: A higher rate of cardiovascular thromboembolic events was observed in patients treated with febuxostat than allopurinol in clinical trials. Monitor for signs and symptoms of MI and stroke.
Liver Enzyme Elevation: Transaminase elevations have been observed in febuxostat -treated patients. Monitor liver function tests periodically.
","Pediatric Use: Safety and effectiveness in pediatric patients under 18 years of age have not been established
","Febustat was studied in healthy subjects in doses up to 300 mg daily for seven days without evidence of dose-limiting toxicities.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+1547,Favipiravir,favipiravir-1547,https://medex.com.bd/attachments/YrTivu0NI4KJLpdoDCeyhI00g23NJI/favipiravir-prescribing-information,Anti-viral drugs,Influenza,"Treatment of novel or re-emerging pandemic influenza virus infections (limited to cases in which other influenza antiviral drugs are ineffective or not sufficiently effective).
","Anti-viral drugs
","Favipiravir is a new antiviral drug against influenza. It is metabolized into favipiravir ribosyl triphosphate (favipiravir RTP) by an intracellular enzyme, and favipiravir RTP selectively inhibits RNA polymerase (RNA-dependent RNA polymerase) of the influenza virus, preventing replication of the influenza virus. It is a drug with a mechanism of action different from that of the existing influenza antiviral drugs and effective against all types and sub-types of human influenza A, B, and C viruses in vitro, showing a wide range of anti-viral activity against various influenza virus strains including avian and swine viruses.
","The usual adult dosage is 1600 mg of Favipiravir administered orally twice daily on Day 1, followed by 600 mg orally twice daily from Day 2 to Day 5 or as directed by physicians. The total treatment duration should be 5 days.
",,"In animal studies, decreased RBC production,and increases in liver function parameters such as AST, ALP, ALT and total bilirubin, and increased vacuolization in hepatocytes. Toxicity information regarding Favipiravir in humans is not readily available.
","Favipiravir is contraindicated for pregnant women and women who may possibly be pregnant.
","Most common side effects are Diarrhea and increase of blood uric acid levels.
","Favipiravir may cause delayed development or death of embryos during the early stage of pregnancy. Should not be given during pregnancy.
","Favipiravir should not be given in pregnant women, requirement of the confirmation of non-pregnancy in women of childbearing potential before use, thorough contraception measures from the start of the treatment to 7 days after the end of the treatment. Caution should be taken for Hepatic and renal impaired patient or use Favipiravir as per the direction of registered Physician
","This drug is only approved as an experimental drug and still a lot of studies is needed about it’s efficacy and also toxic reactions and use in children.
","In animal studies, decreased RBC production,and increases in liver function parameters such as AST, ALP, ALT and total bilirubin, and increased vacuolization in hepatocytes. Toxicity information regarding Favipiravir in humans is not readily available.
",,,"Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.
",12
+452,Famotidine,famotidine-452,https://medex.com.bd/attachments/IQh306Fg2jJ4z1wH3JteFQiJmFkrCa/famotidine-oral-prescribing-information,,,"Famotidine is indicated in-
+
+- Gastric ulcer
+- Duodenal ulcer
+- Anastomotic ulcer
+- Acute stress ulcer
+- Reflux esophagitis and
+- Zollinger-Ellison syndrome.
+
+Famotidine is also indicated for the treatment of acute gastritis, chronic gastritis in the acute exacerbation stage.
",,"Famotidine is a histamine H2-receptor antagonist. Famotidine completely inhibits the action of histamine on H2- receptors of parietal cell. It inhibits basal, overnight and pentagastrin stimulated gastric acid secretion. The H2- receptor antagonist activity of Famotidine is slowly reversible, since the drug dissociates slowly from H2-receptor.
","Tablet:
+
+- For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastro-intestinal hemorrhage, reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Famotidine 20 mg twice daily (after breakfast and after supper or before bed time) or Famotidine 40 mg can be administered orally once daily at bed time.
+- For the treatment of acute gastritis, chronic gastritis in acute exacerbation stage: Usual dosage for adults is Famotidine 20 mg orally twice a day (after breakfast and after supper or before bed time). Also Famotidine 40 mg can be orally administered once a day (before bed time), dosage should be adjusted according to age and symptoms. Most ulcer patients heal within 4-8 weeks. For maintenance therapy the recommended oral dose is 20 mg once daily. Or, as directed by the registered physician.
+
+
Powder for Suspension: Gastroesophageal Reflux Disease(GERD):
+
+- <1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8 weeks once daily in patients
+- Age 3 to 11 months: 0.5 mg/kg/dose twice daily up to 8 weeks
+- Age 1 to 2 months: 0.5 mg/kg/dose once daily up to 8 weeks
+- Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks
+
+Patients 1-16 years of age:
+
+- Gastroesophageal Reflux Disease(GERD): 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
+- Duodonal ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
+- Peptic ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
+- Maintenance therapy: 40 mg at daily night.
+- Reflux esophagitis: 2 mg/kg/day
+- Zollinger-Ellison Syndrome: 40 mg 3 times daily.
+
+
Intravenous Injection: In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection Premixed or Famotidine Injection may be administered until oral therapy can be instituted. The recommended dosage for Famotidine Injection Premixed and Famotidine Injection in adult patients is 20 mg intravenously q 12 h. The doses and regimen for parenteral administration in patients with GERD have not been established.
Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.
",,"No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.
","Known hypersensitivity to any component of the drug.
","Eruption, constipation, diarrhoea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness or insomnia may rarely occur.
","Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Famotid is administered to a nursing woman.
","The drug should be used in the minimum required amount depending upon the conditions of the diseases. The drug should be administered carefully with elderly patients, patients with renal failure and hepatic disorders.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+451,Famciclovir,famciclovir-451,https://medex.com.bd/attachments/VxKtgfmE0lPaSM5MmkBz6JhsqxIfZU/famciclovir-prescribing-information,Herpes simplex & Varicella-zoster virus infections,Varicella zoster (chickenpox),"Herpes zoster (shingles), Recurrent herpes labialis, Genital herpes, Acute treatment of recurrent mucocutaneous herpes in HIV-infected patients, Acute treatment of recurrent episodes of genital herpes, Suppression of recurrent episodes of genital herpes
","Herpes simplex & Varicella-zoster virus infections
","Famciclovir rapidly undergoes biotransformation to penciclovir, which has inhibitory activity against HSV types 1 (HSV-1) and 2 (HSV-2), varicella-zoster virus (VZV). Thymidine kinase then phosphorylates penciclovir to a monophosphate form, which is then converted to penciclovir triphosphate. This inhibits HSV-2 DNA polymerase by competing with deoxyguanosine triphosphate, thus inhibiting herpes viral DNA synthesis and replication.
","Oral (Adult)-Herpes zoster (shingles): 500 mg tid for 7 days. Immunocompromised patients: 500 mg tid for 10 days.
Haemodialysis patients: 250 mg after each dialysis run during 7 days. Immunocompromised patients: Same dose but treatment is given for 10 days.
+
+- CrCl (mL/min) <20: 250 mg once daily for 7 days.
+- CrCl (mL/min) 20-39: 500 mg once daily for 7 days.
+- CrCl (mL/min) 40-59: 500 mg bid for 7 days.
+
+
Recurrent herpes labialis: 1.5 g as a single dose.
Haemodialysis patients: 250 mg after dialysis run.
+
+- CrCl (mL/min) <20: 250 mg as a single dose.
+- CrCl (mL/min) 20-39: 500 mg as a single dose.
+- CrCl (mL/min) 40-59: 750 mg as a single dose.
+
+
Genital herpes: 1st episode: 250 mg tid for 5 days. Immunocompromised patients: 500 mg bid for 7 days.
Haemodialysis patients: 250 mg after each dialysis run during 5 days.
+
+- CrCl (mL/min) <20: 250 mg once daily for 5 days.
+- CrCl (mL/min) 20-39: 250 mg bid for 5 days.
+
+
Acute treatment of recurrent mucocutaneous herpes in HIV-infected patients: 500 mg bid for 7 days.
Haemodialysis patients: 250 mg after each dialysis run during 7 days.
+
+- CrCl (mL/min) <20: 250 mg once daily for 7 days.
+- CrCl (mL/min) 20-39: 500 mg once daily for 7 days.
+
+
Acute treatment of recurrent episodes of genital herpes: 125 mg bid for 5 days or 1 g bid for 1 day. Immunocompromised patients: 500 mg bid for 7 days.
Haemodialysis patients: 125 mg after each dialysis run during 5 days. Haemodialysis patients (immunocompromised): 250 mg after each dialysis run during 7 days.
+
+- CrCl (mL/min) <20: 125 mg once daily for 5 days.
+- CrCl (mL/min) ≥20: 125 mg bid for 5 days.
+- CrCl (mL/min) <20: Immunocompromised: 250 mg once daily for 7 days.
+- CrCl (mL/min) 20-39: Immunocompromised: 500 mg once daily for 7 days.
+
+
Suppression of recurrent episodes of genital herpes: 250 mg bid. Immunocompromised patients: 500 mg bid. Suppressive treatment is interrupted every 6-12 mth for observation.
Haemodialysis patients: 125 mg after each dialysis run. Haemodialysis patients (immunocompromised): 250 mg after each dialysis run.
+
+- CrCl (mL/min) 20: 125 mg once daily. Immunocompromised: 250 mg once daily.
+- CrCl (mL/min) 20-39: 125 mg bid. Immunocompromised: 500 mg once daily.
+
",,"Reduced renal excretion resulting to increased plasma concentration w/ probenecid. Raloxifen may reduce the formation of penciclovir, the active metabolite of famciclovir.
","Hypersensitivity to famciclovir and penciclovir.
","Headache, nausea, diarrhoea, fatigue, dizziness, fever, paraesthesia, somnolence, vomiting, constipation, anorexia, abdominal pain, flatulence, dyspepsia; increased serum levels of ALT, alkaline phosphatase, total bilirubin and albumin; pruritus, pharyngitis, sinusitis, injury, generalised pain, rigors, back pain, arthralgia; increased serum phosphate, Na and K levels; abnormal leukocyte counts, purpura, angioedema.
","Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
","Renal impairment. Pregnancy and lactation.
",,"Acute renal failure in patients with renal disease. Management: Supportive and symptomatic treatment. May be removed by haemodialysis.
",,,"Store at 20-25°C.
",11
+449,Ezetimibe,ezetimibe-449,https://medex.com.bd/attachments/uCNtmCAmRhEusu5ae0gcVjWrz3Nl2y/ezetimibe-prescribing-information,Ezetimibe,Obesity,"Primary Hypercholesterolemia: Ezetimibe co-administered with statin is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolemia who are not appropriately controlled with a statin alone.
Ezetimibe monotherapy ... Read more
Primary Hypercholesterolemia: Ezetimibe co-administered with statin is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolemia who are not appropriately controlled with a statin alone.
Ezetimibe monotherapy is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolemia in whom a statin is considered inappropriate or is not tolerated.
Prevention of Cardiovascular Events: Ezetimibe is indicated to reduce the risk of cardiovascular events in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) when added to ongoing statin therapy or initiated concomitantly with a statin.
Homozygous Familial Hypercholesterolaemia (HoFH): Ezetimibe co-administered with a statin, is indicated as adjunctive therapy to diet for use in patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).
Homozygous Sitosterolemia (Phytosterolemia): Ezetimibe is indicated as adjunctive therapy to diet for use in patients with homozygous familial sitosterolemia
","Ezetimibe
","Ezetimibe localises at the brush border of the small intestine and inhibits absorption of cholesterol via the sterol transporter, Niemann-Pick C1-Like1 (NPC1L1). This results in decreased delivery of cholesterol to the liver, reduction of hepatic cholesterol stores and increased clearance of cholesterol from the blood.
","The recommended dose of Ezetimibe is 10 mg once daily. Ezetimibe can be administered with or without food.
",,"Fibrates may increase cholesterol excretion into the bile, leading to cholelithiasis. In a preclinical study in animals, Ezetimibe increased cholesterol in the gallbladder bile. Coadministration of Ezetimibe with fibrates is not therefore recommended until use in patients is studied.
","Hypersensitivity to any component of this medication. The combination of Ezetimibe
with an HMG-CoA reductase inhibitor is contraindicated in patients with active liver
disease or unexplained persistent elevations in serum transaminases.
","Clinical studies of Ezetimibe (administered alone or with an HMG-CoA reductase
inhibitor) demonstrated that Ezetimibe was generally well tolerated. The overall
incidence of adverse events reported with Ezetimibe was similar to that reported with
placebo, and the discontinuation rate due to adverse events was also similar for Ezetimibe
and placebo.
","There are no adequate and well-controlled studies of Ezetimibe in pregnant women. Ezetimibe should be used during pregnancy only if the potential benefit justifies the risk to the fetus
","Exclude or treat secondary causes of dyslipidaemia prior to initiating therapy. Renal and hepatic impairment. Pregnancy and lactation.
","Pediatric Use-
10 to 17 years: No dosage adjustment is required. The clinical experience in pediatric and adolescent patients is however limited. When Ezetimibe is administered with statin, the dosage instructions for statin, in adolescents should be consulted.
Children < 10 years: Ezetimibe is not recommended for use in children below age 10 due to insufficient data on safety and efficacy.
","No cases of overdosage with Ezetimibe have been reported. Administration of Ezetimibe,
50 mg/day, to 15 subjects for up to 14 days was generally well tolerated. In the event of
an overdose, symptomatic and supportive measures should be employed.
",,,"Store in a cool & dry place protected from light and moisture. Keep out of reach of children.
",12
+457,Everolimus,everolimus-457,https://medex.com.bd/attachments/c7i6PvFipUIh7FkN1LTKxHMdmHwbeu/everolimus-prescribing-information,Immunosuppressant,Tuberous sclerosis,"Everolimus is indicated in advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer (Advanced HR+ BC), Advanced Neuroendocrine Tumors (NET); Advanced Renal Cell Carcinoma (RCC); Renal Angiomyolipoma With Tuberous Sclerosis Complex (TSC); Subependymal Giant Cell Astrocytoma ... Read more
Everolimus is indicated in advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer (Advanced HR+ BC), Advanced Neuroendocrine Tumors (NET); Advanced Renal Cell Carcinoma (RCC); Renal Angiomyolipoma With Tuberous Sclerosis Complex (TSC); Subependymal Giant Cell Astrocytoma (SEGA) With Tuberous Sclerosis Complex (TSC)
In combination with ciclosporin for microemulsion & corticosteroids for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving an allogeneic renal or cardiac transplant. In combination with tacrolimus & corticosteroids for the prophylaxis of organ rejection in patients receiving hepatic transplant.
","Immunosuppressant
","Everolimus, a proliferation signal inhibitor, prevents allograft rejection in rodent and nonhuman primate models of allotransplantation. It exerts its immunosuppressive effect by inhibiting the proliferation and thus, clonal expansion, of antigen-activated T cells which is driven by T cell-specific interleukins eg, interleukin-2 and interleukin-15. Everolimus inhibits an intracellular signaling pathway that normally leads to cell proliferation when triggered by the binding of these T cell growth factors to their receptors. The blockage of this signal by everolimus causes cells to be arrested at the G1 stage of the cell cycle.
At the molecular level, everolimus forms a complex with the cytoplasmic protein FKBP-12. In the presence of everolimus, the growth factor-stimulated phosphorylation of the p70 S6 kinase is inhibited. Since p70 S6 kinase phosphorylation is under the control of FRAP (also called m-TOR), this finding suggests that the everolimus-FKBP-12 complex binds to and thus, interferes with the function of FRAP. FRAP is a key regulatory protein which governs cell metabolism, growth and proliferation; disabling FRAP function thus explains the cell cycle arrest caused by everolimus.
","General kidney & heart transplant population: Initially 0.75 mg bd administered as soon as possible after transplantation.
Hepatic transplant: 1 mg bd with initial dose starting 4 wk after transplantation.
Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer, Advanced NET, Advanced RCC, And Renal Angiomyolipoma With TSC: The recommended dose is 10 mg, to be taken once daily at the same time every day. Administer either consistently with food or consistently without food. Everolimus Tablets should be swallowed whole with a glass of water. Do not break or crush tablets. Continue treatment until disease progression or unacceptable toxicity occurs.
",,"CYP3A4 inhibitors &/or inducers, CYP2D6 substrates with narrow therapeutic index, PgP inhibitors, rifampicin, ACE inhibitors, grapefruit juice & live vaccines.
","Patients with hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients. Hypersensitivity reactions manifested by symptoms including, but not limited to, anaphylaxis, dyspnea, flushing, chest pain, or angioedema (e.g., swelling of the airways or tongue, with or without respiratory impairment) have been observed with everolimus and other rapamycin derivatives
","Stomatitis, Constipation, Infections, Asthenia, Fatigue, Cough, Diarrhea, Rash, Anemia, Nausea, Anorexia, Edema, peripheral, Dyspnea, Pyrexia, Vomiting, Headache, Epistaxis, Decreased lymphocytes, Grade 3, Increased glucose, Grade 3, Pneumonitis, Pruritus, Dry skin, Decreased Hgb, Grade 3, Menstrual irregularities, Dysgeusia, Hypertension, Hemorrhage, Tachycardia, CHF
","Pregnancy Category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Lactation: Distribution into breast milk is unknown; not recommended
","Patients taking concomitant ACE inhibitor therapy may be at increased risk for angioedema. Interstitial lung disease/noninfectious pneumonitis; monitor for clinical symptoms or radiological changes; fatal cases have occurred; manage by dose reduction or discontinuation until symptoms resolve, and consider use of corticosteroids; pulmonary hypertension (including pulmonary arterial hypertension) as a secondary event reported
Elicits immunosuppressive effects and may increase risk for infections; some infections have been severe or fatal; monitor for signs and symptoms and treat promptly. Pneumocystis jiroveci pneumonia, some with a fatal outcome, reported; this may be associated with concomitant use of corticosteroids or other immunosuppressive agents
Mouth ulcers, stomatitis, and oral mucositis are common; management includes mouthwashes (without alcohol or peroxide) and topical treatments May delay wound healing and increase wound-related complications (eg, dehiscence, wound infection, incisional hernia, lymphocele, and seroma)
+
+- Cases of renal failure (including acute renal failure), some fatal, have been observed
+- May cause angioedema and fluid accumulation
+- Decreases Hgb, lymphocytes, ANC, platelets; increases cholesterol, TG, glucose, creatinine
+- Elevations of serum creatinine, urinary protein, blood glucose, and lipids may occur;
+- decreases in hemoglobin, neutrophils, and platelets may also occur; monitor renal
+- function, blood glucose, lipids, and hematologic parameters prior to treatment and periodically thereafter
+- May impair male fertility
+- Child-Pugh Class C hepatic impairment
+- Avoid use of live vaccines during treatment and close contact with live vaccine recipients
+- Can cause fetal harm when administered to a pregnant woman; advise female patients of reproductive potential to use highly effective contraception while receiving everolimus and for up to 8 weeks after ending treatment.
+
",,,,,,9
+1322,Eucalyptol+ Menthol + Thymol,eucalyptol-menthol-thymol-1322,,Topical Analgesics,Teeth whitening,"Eucalypytol, Menthol & Thymol mouthwash is indicated for Gingivitis, Oral hygiene, Cavities, Bad breath, Plaque, Gum disease, Teeth cleaner & brighter.
","Topical Analgesics, Topical anti-inflammatory preparations
",,"Rinse with 20 ml Antiseptic Mouthwash for 30 seconds, twice daily (morning and evening). Then rinse with water. Do not swallow. Not indicated below 12 years of age.
",,,"Hypersensitivity
","Do not rinse, eat, or smoke for thirty minutes after using a mouthwash. Doing so will diminish the effects of the mouthwash.
","FDA has not yet classified the drug into a specified pregnancy category.
","Do not swallow. It is not indicated below 12 years of age. Keep out of the reach of children. Keep in a cool and dry palace. Do not use if cap seal is broken.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",8
+447,Eucalyptol + Menthol + Methyl Salicylate + Thymol + Sodium Fluoride,eucalyptol-menthol-methyl-salicylate-thymol-sodium-fluoride-447,,Oral preparations,Plaque,"Dental cavities, Tooth decay, Bad breath, Dental plaque, Gingivitis
","Oral preparations
","Eucalyptol is a natural organic compound which is a colorless liquid. It is a cyclic ether and a monoterpenoid. Eucalyptol is an ingredient in many brands of mouthwash and cough suppressant. It controls airway mucus hypersecretion and asthma via anti-inflammatory cytokine inhibition.
Menthol: It provides cooling sensation by stimulation of cooling receptor and gives local anesthetic action
Methyl Salicylate: It penetrates and reaches at high concentration in pain regions and inhibit the prostaglandin synthesis and relieves pain effectively
Thymol, one of the chemicals in thyme, is used with another chemical, chlorhexidine, as a dental varnish to prevent tooth decay. In foods, thyme is used as a flavoring agent. In manufacturing, red thyme oil is used in perfumes. It is also used in soaps, cosmetics, and toothpastes.
Fluoride salts are often added to municipal drinking water (as well as certain food products in some countries) for the purposes of maintaining dental health. The fluoride enhances the strength of teeth by the formation of fluorapatite, a naturally occurring component of tooth enamel. Toothpaste often contains sodium fluoride to prevent cavities, although tin(II) fluoride is generally considered superior for this application.
","Adults and children 6 years of age and older: Rinse full strength for 1 minute with 10 ml in morning and night. Do not swallow.
Children under 6 years of age: Consult a dentist or doctor.
",,"There are no known drug interactions and none well documented.
","Hypersensitivity
","Local irritation of mouth, nausea & vomiting.
","Pregnancy Category: Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
","Do not swallow. It is not indicated below 12 years of age. Do not rinse, eat, or smoke for thirty minutes after using a mouthwash. Doing so will diminish the effects of the mouthwash.
",,,,,"Store in a cool & dry place. Keep out of reach of children. Cold weather may cloud this product but its antiseptic & anticavity properties are not affected.
",10
+446,Etoricoxib,etoricoxib-446,https://medex.com.bd/attachments/AJI21sx4CJ59xlzZgTw3kNp70sA9QC/etoricoxib-prescribing-information,Non-steroidal Anti-inflammatory Drugs (NSAIDs),Rheumatoid arthritis,"Etoricoxib is indicated for the symptomatic relief of-
+
+- Osteoarthritis (OA)
+- Rheumatoid arthritis (RA)
+- Ankylosing spondylitis, and
+- The pain and signs of inflammation associated with acute gouty arthritis.
+- For the short-term treatment of moderate pain associated with dental surgery.
+
","Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.
","Adult and adolescent over 16 years:
+
+- Osteoarthritis: The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy.
+- Rheumatoid arthritis: The recommended dose is 90 mg once daily.
+- Ankylosing spondylitis: The recommended dose is 90 mg once daily.
+- Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
+- Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.
+
+Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.
",,"With medicine:
+
+- Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
+- Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
+- Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
+- Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
+- Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.
+
+With food & others: Take without regards to meals.
","
+- Hypersensitivity to the active substance or to any of the excipients.
+- Active peptic ulceration or active gastro-intestinai (Gl) bleeding.
+- Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
+- Pregnancy and lactation.
+- Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score 10).
+- Estimated renal creatinine clearance <30 ml/min.
+- Children and adolescents under 16 years of age.
+- Inflammatory bowel disease.
+- Congestive heart failure (NYHA ll-IV).
+- Patients with hypertension whose blood pressure is persistently elevated above 140/90 mmHg and has not been adequately controlled.
+- Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
+
","Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.
","The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.
","
+- Caution is advised with treatment of patients most at risk of developing a gastrointestinal complication with NSAIDs; the elderly, patients using any other NSAID or acetylsalicylic acid concomitantly or patients with a prior history of gastrointestinal disease, such as ulceration and Gl bleeding.
+- Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with Etoricoxib after careful consideration.
+- Administration of Etoricoxib may cause a reduction in prostaglandin formation and, secondarily, in renal blood flow, and thereby impair renal function. Monitoring of renal function in such patients should be considered.
+- Caution should be exercised in patients with a history of cardiac failure, left ventricular dysfunction, or hypertension and in patients with pre-existing edema from any other reason.
+- Any patients with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormalliver function test has occurred, should be monitored. If signs of hepatic insufficiency occur, or if persistently abnormal liver function tests (three times the upper limit of normal) are detected, Etoricoxib should be discontinued.
+- Etoricoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
+- Etoricoxib may mask fever and other signs of inflammation. Caution should be exercised when co-administering Etoricoxib with warfarin or other oral anticoagulants.
+
",,"Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.
",,,"Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.
",11
+456,Etoposide,etoposide-456,https://medex.com.bd/attachments/TRNObaKvzkxTK7KbGNRWasruVzAkfL/etoposide-capsule-prescribing-information,Cytotoxic Chemotherapy,Testicular cancer,"Small Cell Lung Cancer: Etoposide Capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.
Etoposide is also indicated in Testicular cancer, Small cell lung cancer
","Cytotoxic Chemotherapy
","Etoposide is a derivative of podophyllotoxin that inhibits DNA synthesis resulting in the arrest of the cell cycle. At low doses, it inhibits cells from entering cell cycle and at high doses, cells entering mitosis are lysed.
","Intravenous (Adult)-
+Small cell lung cancer: 35 mg/m2/day for 4 days to 50 mg/m2/day for 5 days. May repeat course at 3-4 wkly intervals after recovery from any toxicity. Inj must be diluted with 5% dextrose or normal saline to give a final concentration of 0.2-0.4 mg/ml and injected over 30-60 minutes. When given via oral capsules: the recommended dose is twice the IV dose rounded to the nearest 50 mg.
Testicular cancer: For combination therapy: 50-100 mg/m2/day from days 1-5, or 100 mg/m2 on days 1, 3 and 5. May repeat course at 3-4 wkly intervals after recovery from any toxicity. Inj must be diluted with 5% dextrose or normal saline to give a final concentration of 0.2-0.4 mg/ml and injected over 30-60 minutes.
+Oral (Adult)-
+Small cell lung cancer: Twice the IV dose, rounded to the nearest 50 mg.",,"Synergism with other cytotoxic drugs. Caution when admin with drugs that inhibit phosphatase activity. Cyclosporin A may reduce the clearance of etoposide.
","Hypersensitivity, pregnancy, lactation.
","Leukopenia, Nausea and Vomiting, Thrombocytopenia, Alopecia, Anorexia, Diarrhea, Leukopenia, Anemia, Pancytopenia, Stomatitis, Hepatic toxicity, Type 1 hypersensitivity, Orthostatic hypotension, Peripheral neuropathy
Malaise,Shivering,Asthenia,Fever,Mucous membrane inflammation, Hyperuricemia, Local soft tissue toxicity has been reported following extravasation;
","Pregnancy category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Lactation: not known if excreted in breast milk, discontinue drug or do not nurse
","Skin reactions may occur with accidental exposure; renal or hepatic disease. Periodic CBCs should be done before, during and after therapy. Increased risk of etoposide-toxicity in patients with low serum albumin. Acrylic material has been shown to crack and leak when used with undiluted etoposide inj.
","Renal impairment: CrCI: 15-50 ml/min- 75% of the recommended dose.
",,,,,10
+480,Fluocinolone Acetonide,fluocinolone-acetonide-480,https://medex.com.bd/attachments/6nk43fuTjXhchpcNxTHoDpvFfNv7vx/fluocinolone-acetonide-cream-prescribing-information,Fluocinolone & Combined Preparations,Tularaemia,"This cream or ointment are suitable for treating a wide variety of local inflammatory, pruritic and allergic disorders of the skin. This is particularly suitable for topical application in:
+
+- Eczema and dermatitis: Atopic eczema, seborrhoeic eczema, discoid eczema, otitis externa, contact dermatitis, neurodermatitis.
... Read more
This cream or ointment are suitable for treating a wide variety of local inflammatory, pruritic and allergic disorders of the skin. This is particularly suitable for topical application in:
+
+- Eczema and dermatitis: Atopic eczema, seborrhoeic eczema, discoid eczema, otitis externa, contact dermatitis, neurodermatitis.
+- Prurigo, Psoriasis, lichen planus. Discoid lupus erythematosus.
+
+This is indicated for inflammatory dermatoses, where secondary bacterial infection is present or likely to occur.
","Fluocinolone & Combined Preparations
","Fluocinolone acetonide is a corticosteroid primarily used in dermatology to reduce skin inflammation and relieve itching. It is a synthetic hydrocortisone derivative. Fluocinolone acetonide was also found to strongly potentiate TGF-β-associated chondrogenesis of bone marrow mesenchymal stem/progenitor cells, by increasing the levels of collagen type II by more than 100 fold compared to the widely used dexamethasone.
","A small quantity of cream or ointment is applied lightly up to two or three times a day, and massaged gently and thoroughly into the skin. These recommendations apply to both children and adults, including the elderly.
",,,"Primary infections of the skin and in rosacea, acne, perioral dermatitis, anogenital pruritis and napkin eruption. Also known hypersensitivity to neomycin.
","Side-effects are extremely rare, but as with all topical corticosteroids, patient may show hypersensitivity reaction.
","Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development, including cleft palate intrauterine growth retardation. There may be a small risk of such effects on the human fetus. When topical steroid treatment is necessary, minimize the amount and length of treatment.
","Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development, including cleft palate intrauterine growth retardation. There may be a small risk of such effects on the human fetus. When topical steroid treatment is necessary, minimize the amount and length of treatment.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+477,Flunarizine,flunarizine-477,https://medex.com.bd/attachments/A9ALQvtGpV6So1YnIohtJIQpxYgcsj/flunarizine-prescribing-information,Miscellaneous prophylactic migraine preparations,Vertigo,"Flunarizine is indicated for
+
+- Prophylaxis of classic (with aura) or common (without aura) migraine
+- Symptomatic treatment of vestibular vertigo (due to a diagnosed functional disorder of the vestibular system).
+- Peripheral Vascular Disease (PVD)
+- Motion sickness
+- Refractory epilepsy resistant to conventional antiepileptic therapy.
+
","Miscellaneous prophylactic migraine preparations
","Flunarizine is the difluorinated derivative of cinnarizine. It is a selective calcium channel antagonist. By reducing excessive transmembrane influx of calcium Flunarizine prevents cellular calcium overload. It does not interfere with normal cellular calcium homeostasis. Flunarizine also has some antihistaminic and sedative properties. It binds at an affinity of 99% to plasma protein.
","Migraine Prophylaxis:
+
+- Starting Dose: 10 mg at night in patients less than 65 years of age and 5 mg daily in patients older than 65 years. If, during this treatment depressive, extrapyramidal or other unacceptable symptoms occur, administration should be discontinued. If, after 2 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued.
+- Maintenance Treatment: If a patient is responding satisfactorily and if a maintenance treatment is needed, the dose should be decreased to 5 days treatment at the same daily dose with two successive medicine free days every week. Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and it should be re-initiated only if the patient relapses.
+
+
Peripheral Vascular disease: 10 mg twice daily, up to 30 mg per day if required.
Vertigo & motion sickness: 10-20 mg daily for adults and 5 mg daily for children (> 40 kg).
Epileptic seizure: 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy
",,"Galactorrhoea has been reported in few women on oral contraceptives within the first two months of Flunarizine treatment. Hepatic enzyme inducers such as Carbamazepine and Phenytoin may interact with flunarizine by increasing its metabolism. So an increase in dosage of flunarizine may be required.
","Hypersensitivity to Flunarizine. Flunarizine is contra-indicated in patients with a history of depressive illness, or with pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders.
","Drowsiness and/or fatigue, as well as weight gain and/or increased appetite may occur. The following adverse experiences have been reported during chronic treatment with Flunarizine: depression, of which female patients with a history of depressive illness may be particularly at risk; extrapyramidal symptoms (such as bradykinesia, rigidity, akathisia, orofacial dyskinesia, tremor), of which elderly patients seem particularly at risk. Infrequently reported adverse reaction are: heartburn; nausea; gastralgia; insomnia; anxiety; galactorrhoea; dry mouth; muscle ache; skin rash.
","Safety in pregnancy and lactation has not been established.
","Flunarizine may lead to drowsiness which is aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be cautioned against driving motor vehicles or performing other potentially hazardous tasks where a loss of mental alertness may lead to accidents. Flunarizine is not suited for aborting a migraine attack. The possible occurrence of an attack is therefore no reason to increase the dose of Flunarizine. This treatment may give rise to extrapyramidal and depressive symptoms and reveal Parkinsonism, especially in predisposed patients such as the elderly. Flunarizine should therefore be used with caution in such patients.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+1405,Fludrocortisone Acetate,fludrocortisone-acetate-1405,https://medex.com.bd/attachments/TcPAFQl6A3sSWOB6tL7RfPvL49fT61/fludrocortisone-acetate-prescribing-information,Corticosteroid,Salt losing adrenogenital syndrome,"Used for oral mineralocorticoid replacement therapy in:
+
+- Primary and secondary adrenocortical insufficiency in Addison’s disease
+- Salt losing adrenogenital syndrome
+- Postural hypotension
+
","Corticosteroid
","Fludrocortisone binds the mineralocorticoid receptor (aldosterone receptor). This binding (or activation of the mineralocorticoid receptor by fludrocortisone) in turn causes an increase in ion and water transport and thus raises extracellular fluid volume and blood pressure and lowers potassium levels.
","Primary and secondary Adrenocortical Insufficiency in Addison’s disease: Usual dose may range from 0.2 mg 3 times weekly to 0.2 mg daily. If hypertension occurs, reduce dosage to 0.05 mg daily. Administer concomitantly with Cortisone or hydrocortisone.
Salt-Losing Adrenogenital Syndrome: 0.1 to 0.2 mg/day.
Postural Hypotension: 0.1-0.4 mg daily to diabetic patients with postural hypotension; 0.05-0.2 mg daily to patients with postural hypotension secondary to Levodopa therapy.
",,"Interactions can occur with following drugs: Amphotericin B, potassium depleting diuretics, anticholinesterases, anticoagulants, antidiabetics. Antitubercular drugs, cyclosporine, digitalis glycosides, oral contraceptives and ketoconazole .
","In case of adrenal insufficiency, no absolute contraindications are applicable. In the treatment of non-endocrine diseases where pharmacological dose are more likely to be used, the contraindications to be considered carefully. Relative contraindications include: systemic fungal infection, hypersensitivity to Fludrocortisone, diabetic mellitus, osteoporosis and acute infection.
","Most adverse reactions are caused by the drug’s mineralocorticoid activity (retention of sodium andwater) include erythema, purpura, vertigo, pancreatitis, increased intraocular pressure, muscular weakness, hypertension, edema, cardiac enlargement, congestive heart failure, steroid myopathy, peptic ulcer, osteoporosis, convulsions, menstrual irregularities, potassium loss, hypokalemic alkalosis, allergic and anaphylactic reaction etc. When Fludrocortisones is used in the small dosages recommended, side effects are not usually a problem; however the above mentioned unwanted effects should be kept in mind, particularly when Fludrocortisones is used over a prolonged period of time or in conjunction with cortisone or a similar glucocorticoid.
","Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Fludrocortisone is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.
Lactation: There are no data on the excretion of fludrocortisone into human milk. However, corticosteroids (systemic therapy) are distributed into breast milk and could cause growth suppression and/or other adverse effects in nursing infants. The manufacturer recommends that caution be used when administering Fludrocortisone to nursing women.
","Because of its marked effect on sodium retention, the use of Fludrocortisone in the treatment of conditions other than those indicated herein is not advised. Fludrocortisone should be used with caution in patients suffering from different infections (like tuberculosis, measles, chicken pox, herpes zoster or threadworm infestation), congestive cardiac failure, hypertension, renal insufficiency, osteoporosis, drug-induced secondary adrenocortical insufficiency, peptic ulcer, intestinal anastomosis and ulcerative colitis.
",,"Overdose is unlikely; however, treatment of overdose is by supportive and symptomatic therapy.
",,,"Store in a cool and dry place, protected from light.
",11
+1258,Fludarabine Phosphate,fludarabine-phosphate-1258,https://medex.com.bd/attachments/SJ5o6XPnssnL8YUdgJwLfNrXYq5vVO/fludarabine-phosphate-tablets-prescribing-information,Cytotoxic Chemotherapy,Non-Hodgkin lymphoma,"Fludarabine Phosphate is indicated for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. The safety and effectiveness of Fludarabine ... Read more
Fludarabine Phosphate is indicated for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. The safety and effectiveness of Fludarabine Phosphate in previously untreated or non-refractory patients with CLL have not been established.
","Cytotoxic Chemotherapy
","Fludarabine phosphate is rapidly dephosphorylated to 2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-ATP. This metabolite appears to act by inhibiting DNA polymerase alpha, ribonucleotide reductase and DNA primase, thus inhibiting DNA synthesis leading to cell death. The mechanism of action of this antimetabolite is not completely characterized and may be multi-faceted.
","Intravenous (Adult):
Chronic lymphocytic leukaemia: 25 mg/m2 BSA daily given by bolus inj or by IV infusion over 30 minutes for 5 consecutive days. Courses may be repeated every 28 days, usually for up to 6 cycles.
Oral (Adult):
Chronic lymphocytic leukaemia: 40 mg/m2 BSA daily for 5 consecutive days. Courses may be repeated every 28 days, usually for up to 6 cycles.
",,"Co-administration with pentostatin may lead to pulmonary toxicity. Reduced metabolic activation of fludarabine with cytarabine. Reduced therapeutic efficacy with dipyridamole and other adenosine uptake inhibitors.
","Renal impairment (CrCl <30 mL/min); decompensated haemolytic anaemia. Pregnancy and lactation. Concomitant use of live vaccines.
","Fever, chills, cough, dyspnoea, pneumonia; GI disturbances, stomatitis; oedema; tumour lysis syndrome; skin rashes; haemolytic anaemia, haemorrhagic cystitis; neurological disturbances including peripheral neuropathy, agitation, confusion, visual disturbances and coma. Progressive encephalopathy and blindness (high doses).
","Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Routine monitoring of blood counts and Hb conc. Monitor for signs of autoimmune haemolytic anaemia; elderly. Avoid contact with skin and eyes; avoid inhalation. Myelosuppression may be cumulative and severe increasing risk of opportunistic infections. Increased risk of tumour lysis syndrome in patients with high tumour burden.
","Renal Impairment:
+
+- CrCl 30-70: May reduce the doses by up to 50%
+- Severe impairment: Avoid
+
",,,,"Refrigerate at 2-8° C
",11
+475,Fluconazole (Ophthalmic),fluconazole-ophthalmic-475,,Ophthalmic Anti-fungal Products,Fungal corneal ulcers,"For the treatment of fungal corneal ulcers/ keratitis.
","Ophthalmic Anti-fungal Products
","Fluconazole is fungistatic in action. It inhibits cytochrome P-450 14-α demethylase in susceptible fungi which leads to accumulation of lanosterol and decreased concentration of ergosterol thereby altering cellular membrane resulting in increased membrane permeability, leakage of essential elements and impaired uptake of precursor molecules to DNA.
","Instill 1 drop to be instilled into the affected eye(s) 5 times daily.
",,"Fluconazole can alter pharmacokinetics of certain drugs undergoing hepatic metabolism.
","The drug is contraindicated in patients with hypersensitivity to azoles.
","This drug is generally well tolerated. Eosinophillia has been reported in some patients.
","Use in pregnancy: Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Fluconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: Nursing mother should not be given as the drug is excreted in breast milk in concentration similar to plasma.
","Use of fluconazole may result in overgrowth of non-susceptible strains of candida other than Candida albicans
",,,,,"Keep out of the reach of children. Store in a cool, dry place, away from heat and direct light. Do not use more than 4 weeks after opening the bottle
",10
+474,Fluconazole,fluconazole-474,https://medex.com.bd/attachments/vuwGom8S3H2ObKkGjpBbDJZnnUy1XV/fluconazole-gelatin-capsules-prescribing-information,Drugs for subcutaneous and mycoses,Vaginal candidiasis or thrush,"Fluconazole is indicated for the treatment of vaginal candidiasis, oropharyngeal & esophageal candidiasis and cryptococcal meningitis. It is also effective for the treatment of urinary tract infection caused by candida, peritonitis and systemic candida infections (including candidemia, disseminated candidiasis and pneumonia).
","Drugs for subcutaneous and mycoses
","Fluconazole is a triazole antifungal agent. It is a potent inhibitor of fungal cytochrome P-450 dependent enzymes. Cytochrome P-450 enzyme system is essential component of fungal cell membrane which is responsible for the synthesis of ergosterol.
","Adult (oral)-
+
+- Vaginal candidiasis: 150 mg as a single dose.
+- Oropharyngeal candidiasis: 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of this infection generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse.
+- Esophageal candidiasis: 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/day may be used. Patients should be treated for a minimum of three weeks and for at least two weeks following resolution of symptoms.
+- Systemic candida infections: Optimal therapeutic dosage and duration of therapy have not been established. Sometimes, doses of up to 400 mg daily have been used.
+- Urinary tract infections caused by candida and peritonitis: 50-200 mg daily have been used.
+- Cryptococcal meningitis: 400 mg on the first day, followed by 200 mg once daily.
+- Prophylaxis in patients undergoing bone marrow transplantation: 400 mg once daily.
+
+Child (oral):
+
+- Doses of 3-6 mg/kg daily have been used. Doses up to 12 mg/kg is recommended.
+
+
Intravenous-
+
+- Adult: Invasive candidal infections including candidaemia and disseminated candidiasis and cryptococcal infections including meningitis, by IV, 400 mg initially then 200 mg daily, increased if necessary to 400 mg daily, treatment continued according to response (at least 6-8 weeks for cryptococcal meningitis)
+- Child: 6-12 mg/kg daily (every 72 hours in neonate up to 2 weeks old, every 48 hours in neonate 2-4 weeks old); maximum 400 mg daily. Prevention of relapse of cryptococcal meningitis, by IV, 100-200 mg daily.
+
",,"Concomitant use of cyclosporin or phenytoin with Fluconazole increases the plasma level of cyclosporin or phenytoin. Concomitant use of Fluconazole & warfarin prolongs the prothrombin time. Rifampicin level is decreased when used with Fluconazole.
","Fluconazole should not be used in patients with known hypersensitivity to Fluconazole or to related triazole compounds.
","Fluconazole is well tolerated. Most common side effects of using Fluconazole includes nausea, vomiting, abdominal pain, diarrhoea, headache and skin rash.
","US FDA Pregnancy category of Fluconazole is C. So, Fluconazole should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
","Fluconazole should be administered with caution to patients having proarrhythmic conditions.
",,,,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",10
+473,Flucloxacillin Sodium,flucloxacillin-sodium-473,https://medex.com.bd/attachments/k4l3TzgZvVPPgs7AbN05Q4r5kXIa9u/flucloxacillin-sodium-capsules-oral-solution-prescribing-information,Penicillinase-resistant penicillins,Wounds,"Flucloxacillin is indicated for the treatment of infections due to Gram-positive organisms, including infections caused by penicillinase producing staphylococci. These indications include:
+
+- Skin and soft tissue infections: Boils, abscess, carbuncles, infected skin conditions (e.g. ulcer, eczema, acne, furunculosis, cellulitis, infected wounds, infected burns, otitis media and externa, impetigo).
... Read more
Flucloxacillin is indicated for the treatment of infections due to Gram-positive organisms, including infections caused by penicillinase producing staphylococci. These indications include:
+
+- Skin and soft tissue infections: Boils, abscess, carbuncles, infected skin conditions (e.g. ulcer, eczema, acne, furunculosis, cellulitis, infected wounds, infected burns, otitis media and externa, impetigo).
+- Respiratory tract infections: Pneumonia, lung abscess, empyema, sinusitis, pharyngitis, tonsillitis, quinsy.
+- It is also used for the treatment of other infections i.e. osteomyelitis, enteritis, endocarditis, urinary tract infection, meningitis, septicaemia caused by Flucloxacillin-sensitive organisms.
+- As a prophylactic agent, it is used during major surgical procedures where appropriate; for example, cardiothoracic and orthopedic surgery.
+
","Penicillinase-resistant penicillins
","Flucloxacillin is active against Gram-positive organisms including penicillinase producing strains. It has little activity against Gram-negative bacilli. Flucloxacillin acts by inhibiting the formation of cell wall of bacteria. Flucloxacillin is isoxazolyl penicillin which combined the properties of resistance to hydrolysis by penicillinase, gastric acid stability and activity against gram-positive bacteria. Flucloxacillin is a bactericidal antibiotic that is particularly useful against penicillinase-producing staphylococci. Flucloxacillin kills bacterial cellwall, thus interfering with peptidoglycan synthesis. Peptidoglycan is a heteropolymeric structure that provides the cell wall with its mechanical stability. The final stage of peptidoglycan synthesis involves the completion of the cross-linking with the terminal glycine residue of the pentaglycin bridge linking to the fourth residue of the pentapeptide (D-alanine). The transpeptidase enzyme that performs this step is inhibited by Flucloxacillin. As a result the bacterial cellwall is weakened, the cell swells and then ruptures. Flucloxacillin resists the action of bacterial penicillinase probably because of the steric hindrance induced by the acyl side chain which prevents the opening of the β- lactam ring.
","Oral administration:
+
+- Adult: 250 mg four times daily. Dosage may be doubled in severe infections. In osteomyelitis and endocarditis, up to 8 gm daily is used in 6-8 hourly divided doses.
+- Children (2-10 years): 1/2 of adult dose.
+- Children (Under 2 years): 1/4 of adult dose.
+
+Parenteral administration:
Adult or Elderly:
+
+- Intramuscular Injection: 250 mg four times daily.
+- Intravenous Injection: 250 mg-1 g four times daily by slow injection over 3 to 4 minutes or by intravenous infusion.
+- All systemic doses may be doubled in severe infections: doses up to 8 g daily have been suggested for endocarditis or osteomyelitis.
+
+Children:
+
+- 2-10 years: half of the adult dose.
+- Under 2 years: a quarter of the adult dose.
+
","Oral doses should be administered 1 hour before meal.
","Concurrent use of Flucloxacillin and may result in increased level of Flucloxacillin in blood for prolonged period.
","Flucloxacillin is contraindicated in penicillin hypersensitive patients.
","There have been some common side effects of gastrointestinal tract such as nausea, vomiting, diarrhoea, dyspepsia and other minor gastrointestinal disturbances. Besides these rashes, urticaria, purpura, fever, interstitial nephritis, hepatitis and cholestatic jaundice have been reported.
","US FDA Pregnancy Category of Flucloxacillin is B. There are, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Flucloxacillin have been shown to be excreted in human milk. So, caution should be exercised when Flucloxacillin is administered to a lactating mother.
","Flucloxacillin should be used with caution in patients with evidence of hepatic dysfunction. Caution should also be exercised in the treatment of patients with an allergic diathesis.
","In severe renal failure (creatinine clearance <10 ml/min), a reduction in dose or an extension of dose interval should be considered.
",,,"Flucloxacillin has been used in other routes in conjunction with systemic therapy. It has been administered in a dose of 250 mg to 500 mg daily by intraarticular injection, dissolved if necessary in a 0.5% solution of lignocaine hydrochloride, and by intrapleural injection in a dose of 250 mg daily. Using powder for injection, 125 mg-250 mg has been dissolved in 3 ml of sterile water and inhaled by nebuliser four times daily.
","Keep in a dry place away from light and heat. Keep out of the reach of children.
",13
+2048,Flibanserin,flibanserin-2048,https://medex.com.bd/attachments/SOCBJdJFGXJb5Powj92EY8vBfiL1tE/flibanserin-prescribing-information,Serotonin-norepinephrine reuptake inhibitor (SNRI),,"Flibanserin is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to:
+
+- A co-existing medical or psychiatric condition,
... Read more
Flibanserin is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to:
+
+- A co-existing medical or psychiatric condition,
+- Problems within the relationship, or
+- The effects of a medication or other drug substance.
+
+Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation or partner.
","Serotonin-norepinephrine reuptake inhibitor (SNRI)
","Flibansetrin has high affinity for serotonin receptors in the brain: it acts as an agonist on 5-HT1A and an antagonist on 5-HT2A. In vivo, flibanserin binds equally to 5-HT1A and 5-HT2A receptors. However, under higher levels of brain 5-HT (i.e., under stress), flibanserin may occupy 5-HT2A receptors in higher proportion than 5-HT(1A) receptors. It may also moderately antagonize D4 (dopamine) receptors and 5-HT2B and 5-HTB2C. Its action on neurotransmitter receptors may contribute to reduction in serotonin levels and increase in dopamine and norepinephrine levels, all of which may play part in reward processing.
","The recommended dosage of Flibanserin is 100 mg administered orally once per day at bedtime. Flibanserin is dosed at bedtime because administration during waking hours increases the risks of hypotension, syncope, accidental injury, and central nervous system (CNS) depression (such as somnolence and sedation). If a dose of Flibanserin is missed at bedtime, instruct the patient to take the next dose at bedtime on the next day. Instruct the patient to not double the next dose.
Pediatric Use: Flibanserin is not indicated for use in pediatric patients.
Geriatric Use: Flibanserin is not indicated for use in geriatric patients. Safety and effectiveness have not been established in geriatric patients.
",,"
+- Oral Contraceptives and Other Weak CYP3A4 Inhibitors: Increases flibanserin exposures and incidence of adverse reactions.
+- Strong CYP2C19 Inhibitors: Increases flibanserin exposure which may increase risk of hypotension, syncope, and CNS depression.
+- CYP3A4 Inducers: Use of flibanserin not recommended; flibanserin concentrations substantially reduced.
+- Digoxin: Increases digoxin concentrations, which may lead to digoxin toxicity. Increase monitoring of digoxin concentrations.
+
","Flibanserin is contraindicated: with use of alcohol, with concomitant use with moderate or strong CYP3A4 inhibitors, in patients with hepatic impairment.
","Most common adverse reactions are Dizziness, Somnolence, Nausea, Fatigue, Insomnia, Dry mouth.
","There are no studies of Flibanserin in pregnant women to inform whether there is a drug-associated risk in humans. Flibanserin is excreted in rat milk. It is unknown whether flibanserin is present in human milk, whether Flibanserin has effects on the breastfed infant, or whether Flibanserin affects milk production. Because of the potential for serious adverse reactions including sedation in a breastfed infant, breastfeeding is not recommended during treatment with Flibanserin.
","Hypotension and Syncope with Flibanserin Alone: Patients with pre-syncope should immediately lie supine and promptly seek medical help if symptoms do not resolve.
Central Nervous System (CNS) Depression (e.g., Somnolence, Sedation): Can occur with Flibanserin alone. Exacerbated by other CNS depressants, and in settings where flibanserin concentrations are increased. Patients should avoid activities requiring full alertness (e.g., operating machinery or driving) until at least 6 hours after each dose and until they know how Flibanserin affects them.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+472,Flavoxate Hydrochloride,flavoxate-hydrochloride-472,https://medex.com.bd/attachments/F4Fv59mdKblaI0cCwqx2nD3iFz9B67/flavoxate-hydrochloride-100-mg-tablets-prescribing-information,BPH/ Urinary retention/ Urinary incontinence,Urinary frequency and urgency,"Flavoxate is indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis and urethrocystitis.
","BPH/ Urinary retention/ Urinary incontinence
","Flavoxate acts as a direct antagonist at muscarinic acetylcholine receptors in cholinergically innervated organs. Its anticholinergic-parasympatholytic action reduces the tonus of smooth muscle in the bladder, effectively reducing the number of required voids, urge incontinence episodes, urge severity and improving retention, facilitating increased volume per void.
","Adults and children over 12 years of age: 100 mg to 200 mg 3 times a day. With improvement of symptoms, the dose may be reduced.
Pediatric Use: Safety and effectiveness in children below the age of 12 years have not been established.
",,,"Flavoxate is contraindicated in patients who have any of the following obstructive conditions: pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the lower urinary tract.
","Gastrointestinal: Nausea, vomiting, dry mouth.
CNS: Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness.
Hematologic: Leukopenia (which is reversible upon discontinuation of the drug).
Cardiovascular: Tachycardia and palpitation.
Allergic: Urticaria and other dermatoses, eosinophilia and hyperpyrexia.
Ophthalmic: Increased ocular tension, blurred vision, disturbance in eye accommodation.
","Pregnancy: Pregnancy Category B. This drug should be used during pregnancy only if clearly needed.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Caution should be exercised when flavoxate is administered to a nursing woman.
","Flavoxate should be given cautiously in patients with suspected glaucoma
",,,,,"Store Flavoxate at room temperature, between 20 and 25 degrees C
",9
+2055,Finerenone,finerenone-2055,https://medex.com.bd/attachments/izqOmK3lgEf5lrsUNQTTexneNZnJFv/finerenone-prescribing-information,,,"Finerenone is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
",,"Finerenone is a nonsteroidal, selective antagonist of the mineralocorticoid receptor (MR), which is activated by aldosterone and cortisol and regulates gene transcription. Finerenone blocks MR mediated sodium reabsorption and MR overactivation in both epithelial (e.g., kidney) and nonepithelial (e.g., heart, and blood vessels) tissues. MR overactivation is thought to contribute to fibrosis and inflammation. Finerenone has a high potency and selectivity for the MR and has no relevant affinity for androgen, progesterone, estrogen, and glucocorticoid receptors.
","Prior to Initiation of Kerendia: Measure serum potassium levels and estimated glomerular filtration rate (eGFR) before initiation. Do not initiate treatment if serum potassium is >5.0 mEq/L.
Recommended Starting Dosage: The recommended starting dose of Kerendia is based on eGFR.
+
+- ≥60 eGFR (mL/min/1.73 m2): Starting dose 20 mg once daily
+- ≥25 to <60 eGFR (mL/min/1.73 m2): Starting dose 10 mg once daily
+- <25 eGFR (mL/min/1.73 m2): Not Recommended
+
+For patients who are unable to swallow whole tablets, Kerendia may be crushed and mixed with water or soft foods such as applesauce immediately prior to use and administered orally
",,"Strong CYP3A4 Inhibitors: Finerenone is a CYP3A4 substrate. Concomitant use with a strong CYP3A4 inhibitor increases finerenone exposure, which may increase the risk of Finerenone adverse reactions. Concomitant use of Finerenone with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice.
Moderate and Weak CYP3A4 Inhibitors: Finerenone is a CYP3A4 substrate. Concomitant use with a moderate or weak CYP3A4 inhibitor increases finerenone exposure, which may increase the risk of Finerenone adverse reactions. Monitor serum potassium during drug initiation or dosage adjustment of either Finerenone or the moderate or weak CYP3A4 inhibitor, and adjust Finerenone dosage as appropriate.
Strong and Moderate CYP3A4 Inducers: Finerenone is a CYP3A4 substrate. Concomitant use of Finerenone with a strong or moderate CYP3A4 inducer decreases finerenone exposure, which may reduce the efficacy of Finerenone. Avoid concomitant use of Finerenone with strong or moderate CYP3A4 inducers.
","Finerenone is contraindicated in patients: Who are receiving concomitant treatment with strong CYP3A4 inhibitors, With adrenal insufficiency.
","The following serious adverse reactions are discussed elsewhere in the labeling: Hyperkalemia.
","There are no available data on Kerendia use in pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal studies have shown developmental toxicity at exposures about 4 times those expected in humans. The clinical significance of these findings is unclear. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
There are no data on the presence of finerenone or its metabolite in human milk, the effects on the breastfed infant or the effects of the drug on milk production. In a pre-and postnatal developmental toxicity study in rats, increased pup mortality and lower pup weight were observed at about 4 times the AUC unbound expected in humans. These findings suggest that finerenone is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because of the potential risk to breastfed infants from exposure to Finerenone, avoid breastfeeding during treatment and for 1 day after treatment.
","Hyperkalemia: Finerenone can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia. Measure serum potassium and eGFR in all patients before initiation of treatment with Finerenone and dose accordingly. Do not initiate Finerenone if serum potassium is >5.0 mEq/L. Measure serum potassium periodically during treatment with Finerenone and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium.
","Pediatric Use: The safety and efficacy of Kerendia have not been established in patients below 18 years of age.
Geriatric Use: Of the 2827 patients who received Kerendia in the FIDELIO-DKD study, 58% of patients were 65 years and older, and 15% were 75 years and older. No overall differences in safety or efficacy were observed between these patients and younger patients. No dose adjustment is required.
Hepatic Impairment: Avoid use of Kerendia in patients with severe hepatic impairment (Child Pugh C). No dosage adjustment is recommended in patients with mild or moderate hepatic impairment (Child Pugh A or B). Consider additional serum potassium monitoring in patients with moderate hepatic impairment (Child Pugh B)
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+471,Finasteride [For B.P.H.],finasteride-for-bph-471,https://medex.com.bd/attachments/JHrx4kCqwb6eZrPR65VkBNwo60wgWe/finasteride-for-bph-prescribing-information,BPH/ Urinary retention/ Urinary incontinence,Supports normal prostate function,"Finasteride is indicated for the treatment and control of benign prostatic hyperplasia (BPH)-
+
+- To cause regression of the enlarged prostate
+- To improve urinary flow
+- To improve the symptoms associated with BPH.
+
","BPH/ Urinary retention/ Urinary incontinence
","Finasteride, a competitive inhibitor of the 5α reductase enzyme which is used in the treatment of benign prostatic hyperplasia. It is selective for 5α reductase type 2 enzyme and has no affinity for androgen receptors. The development of the prostate gland and subsequent BPH is dependent upon conversion of testosterone to dihydrotestosterone (DHT) within the prostate. Finasteride belongs to a new class of specific inhibitors of 5α reductase, an intracellular enzyme, which metabolises testosterone into the more potent androgen, DHT. Finasteride has no affinity for the androgen receptor.
","The recommended dosage is one 5 mg tablet daily. Although early improvement may be seen, treatment for at least six months may be necessary to assess whether a beneficial response has been achieved. Thereafter, treatment should be continued.
",,"No clinically important drug interactions have been identified. Finasteride does not appear to significantly affect the cytochrome P450 linked drug metabolising enzyme system. Compounds which have been tested in man include Propranolol, Digoxin, Glibenclamide, Warfarin, Theophylline, and antipyrine.
","Hypersensitivity to any component of this medication. Finasteride use is also contraindicated in women and paediatric patient
","Finasteride is well tolerated. In clinical studies, the following adverse experiences have been reported as possibly drug related in 1% of patients treated for 12 months with 5 mg Finasteride daily: impotence (3.7%), decreased libido (3.3%), and decreased volume of ejaculate (2.8%).
","Finasteride is contraindicated in women who are or may become pregnant. Finasteride is not indicated for use in women. It is not known whether finasteride is excreted in human milk.
Exposure to finasteride-risk to male fetus: Crushed or broken Finasteride Tablets should not be handled by women who are or may become pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. Similarly, small amounts of finasteride have been recovered from the semen in subjects receiving Finasteride 5 mg/day. It is not known whether a male fetus may be adversely affected if his mother is exposed to the semen of a patient being treated with finasteride. Therefore, when the patients sexual partner is or may become pregnant, the patient should either avoid exposure of his partner to semen (e.g. by use of a condom) or discontinue Finasteride
","General: Since the beneficial response to Finasteride may not be manifested immediately, patients with large residual urine volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy.
Prostate cancer: Digital rectal examination, as well as, other evaluations for prostate cancer, should be performed on patients with BPH prior to initiating therapy with Finasteride and periodically thereafter. Finasteride causes a decrease in serum concentration of markers of prostatic cancer such as prostate specific antigen (PSA); therefore, reduction of serum levels of these markers in patients with BPH treated with Finasteride does not rule out concomitant prostate cancer. No clinical benefit has yet been demonstrated in patients with prostate cancer treated with Finasteride.
","Renal insufficiency: Dosage adjustments are not necessary in patients with renal insufficiency since pharmacokinetic studies did not indicate any change in the disposition of Finasteride.
Hepatic insufficiency: There are no data available in patients with hepatic insufficiency.
Elderly: No dosage adjustment is required in elderly patients.
",,,,"Store at cool and dry place (below 30°C). Protect from light and moisture. Keep all the medicines out of the reach of children.
",11
+1220,Finasteride [For Androgenic Alopecia],finasteride-for-androgenic-alopecia-1220,https://medex.com.bd/attachments/jM2RZjzzfRwYl7ReQoqv9k0FbUEeAv/finasteride-for-androgenic-alopecia-prescribing-information,Miscellaneous topical agents,Androgenic alopecia,"Finasteride is indicated for the treatment of male pattern hair loss (androgenic alopecia) in men only.
","Miscellaneous topical agents
","Finasteride, a competitive inhibitor of steroid Type II 5α reductase, an intracellular enzyme that converts the androgen testosterone into 5α dihydrotestosterone (DHT). Finasteride is a competitive and specific inhibitor of Type II 5α reductase, an intracellular enzyme that converts the androgen testosterone into DHT. Finasteride has no affinity for the androgen receptor and has no androgenic or antiandrogenic effects. Inhibition of Type II 5α reductase blocks the conversion of testosterone to DHT, resulting in significant decreases in serum and tissue DHT concentrations. In men with male pattern hair loss, the balding scalp contains miniaturised hair follicles and increased amounts of DHT compared with hairy scalp. Administration of Finasteride decreases scalp and serum DHT concentrations in these men.
","The recommended dosage is 1 mg once a day. Recur may be administered with or without meals. In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit. Withdrawal of treatment leads to reversal of effect within 12 months.
",,"No drug interactions of clinical importance have been identified.
","Hypersensitivity to any component of this medication. Finasteride use is also contraindicated in women and paediatric patient.
","Finasteride is well tolerated. In clinical studies, the following adverse reactions were reported as possibly drug related in >1% of patients treated for 12 months with Finasteride 1 mg daily : decreased libido (1.8%), erectile dysfunction (1.3%), ejaculation disorder (1.2%) and decreased volume of ejaculate (0.8%).
","No data found
","Caution should be used in the administration of Recur in patients with liver function abnormalities, as Finasteride is metabolised extensively in the liver. Women who are or may potentially be pregnant should not handle crushed or broken tablets of Recur.
",,,,,,9
+470,Filgrastim,filgrastim-470,https://medex.com.bd/attachments/TN1vGAtVS2GRL8krjPOg2KPDJ1SSqZ/filgrastim-us-fda-prescribing-information,Haematopoietic Agents,Peripheral blood progenitor cell collection and therapy,"Filgrastim is indicated to those:
+
+- Cancer patients receiving myelosuppressive chemotherapy
+- Patients with Acute Myeloid Leukemia receiving induction or consolidation chemotherapy
+- Cancer patients receiving bone marrow transplant
+- Patients with severe neutropenia
+- Peripheral blood progenitor cell collection and therapy
+
","Haematopoietic Agents
","Filgrastim is a granulocyte-colony stimulating factor which binds to cell surface receptors on haemetopoietic cells thus stimulating the development of granulocytes to increase their migration and cytotoxicity.
Filgrastim is a glycoprotein which regulates the production and release of functional neutrophils from the bone marrow. Filgrastim causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes. Elevations of neutrophil counts are dose-dependent at recommended doses. Following termination of Filgrastim therapy, circulating neutrophil counts decrease by 50% within 1 to 2 days, and to normal levels within 1 to 7 days.
","Parenteral-
+Chemotherapy-induced neutropenia: 5 mcg/kg daily as a single daily SC inj, as a continuous IV or SC infusion, or as a daily IV infusion over 15-30 minutes, starting not
Bone marrow transplantation: 10 mcg/kg daily by IV infusion over 30 min or 4 hr or continuous IV or SC infusion over 24 hr. Adjust according to response.
+
Subcutaneous-
+Mobilisation of peripheral blood progenitor cells for autologous peripheral blood stem cell transplantation: 10 mcg/kg daily, as a single inj or by continuous infusion, for 4-7 days until the last leucapheresis procedure. If it is given after myelosuppressive chemotherapy: 5 mcg/kg daily by inj; given from the 1st day after chemotherapy completion until expected neutrophil nadir is passed and neutrophil count has returned to normal range, so that leucapheresis can be performed.
Congenital neutropenia: 12 mcg/kg daily in single or divided doses. Adjust according to response. In patients with cyclic or idiopathic neutropenia: 5 mcg/kg daily in single or divided doses. Adjust according to response.
HIV infection and persistent neutropenia: Initially, 1 mcg/kg daily. Dose may be increased to 4 mcg/kg daily until normal neutrophil count is achieved. Maintenance: 300 mcg daily. Max: 4 mcg/kg daily.",,"Drug interactions between Filgrastim and other drugs have not been fully evaluated. Drugs which may potentiate the release of neutrophils, such as lithium should be used with caution.
","Filgrastim is contraindicated in patients hypersensitive to the drug, any ingredient in the formulation, or proteins derived from Escherichia coli.
","Musculoskeletal pain, bone pain, hypersensitivity reactions, splenic enlargement, hepatomegaly, thrombocytopaenia, anaemia, epistaxis, headache, nausea, vomiting, diarrhoea, urinary abnormalities (dysuria, proteinuria, haematuria), osteoporosis, exacerbation of rheumatoid arthritis, transient decrease in blood glucose, raised uric acid, cutaneous vasculitis, transient hypotension.
","Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Filgrastim should not be administered within 24 hours before and after chemotherapy The possibility of Filgrastim acting as a growth factor for any tumor type cannot be excluded. To avoid adverse effects of excessive neutrophils complete blood count is recommended twice per week during treatment. Filgrastim is given by subcutaneous or intravenous infusion as required
","Pediatric precautions: Filgrastim has been used in children 3 months to 18 years of age without unusual adverse effect. However, safety and efficacy of the drug in neonates or patients with autoimmune neutropenia of infancy have not been established.
","The possibility of Filgrastim acting as a growth factor for any tumor type and adverse effects of excessive neutrophils may occur in overdose of Filgrastim.
",,"Dilution of Filgrastim conc less than 5 mcg/ml is not recommended at any time. Filgrastim may be diluted in 5% dextrose as required
","Refrigerate at 2-8° C. Do not freeze.
",13
+468,Fexofenadine Hydrochloride,fexofenadine-hydrochloride-468,https://medex.com.bd/attachments/SbCMYk3GAp0W6EAJX8iCYyhkcNKcAy/fexofenadine-hydrochloride-prescribing-information,Non-sedating antihistamines,Urticaria,"Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.
","Non-sedating antihistamines
","Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. It is rapidly absorbed after oral administration and peak plasma concentration is reached in 2-3 hours. It does not appear to cross the blood brain barrier.
","Seasonal Allergic Rhinitis-Adults and children 12 years and older:
+
+- Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
+- In case of impaired renal function: 60 mg once daily
+
+Children from 6 to 11 years:
+
+- Tablet: 30 mg twice daily or 60 mg once daily
+- In case of impaired renal function: 30 mg once daily
+
+Children from 2 to 11 years
+
+- Suspension: 30 mg or 5 ml twice daily
+- In case of impaired renal function: 30 mg or 5 ml once daily
+
+
Chronic Idiopathic Urticaria-
Adults and children 12 years and older:
+
+- Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
+- In case of impaired renal function: 60 mg once daily
+
+Children from 6 to 11 years:
+
+- Tablet: 30 mg twice daily or 60 mg once daily
+- In case of impaired renal function: 30 mg once daily
+
+Children from 6 months to less than 2 years:
+
+- Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
+- In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily
+
+Children from 2 to 11 years:
+
+- Suspension: 30 mg or 5 ml (1 tsp) twice daily
+- In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily
+
+
",,"Plasma concentration of Fexofenadine Hydrochloride have been increased when given with erythromycin or ketoconazole. Aluminium and magnesium hydroxide containing antacid reduces the absorption of Fexofenadine Hydrochloride.
","Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.
","Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.
","US FDA pregnancy category of Fexofenadine Hydrochloride is C. So, Fexofenadine Hydrochloride should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
","Caution should be exercised in elderly patient and patient with decreased renal function.
",,"In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.
",,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",11
+467,Ferrous Sulfate + Folic Acid + Zinc Sulfate,ferrous-sulfate-folic-acid-zinc-sulfate-467,,"Iron, Vitamin & Mineral Combined preparation","Iron, Folic Acid and zinc deficiency during pregnancy and lactation","This is indicated for the treatment and prophylaxis of Iron, Folic Acid and Zinc deficiency especially during pregnancy and lactation.
","Iron, Vitamin & Mineral Combined preparation
",,"Adult or Elderly: 1 capsule daily. In more severe cases, 2 capsules daily may be required.
Children: Aged over 1 year: 1 capsule daily. The capsule may be opened and the pellets to be mixed with soft cool food, but they must not be chewed.
",,,"Do not use in patients hypersensitive to the components of the product or those with iron overload.
","Dark stools are usual during iron therapy and nausea and other symptoms of gastrointestinal irritation such as anorexia, vomiting, discomfort, constipation and diarrhoea are sometimes encountered. Zinc may also produce a gastrointestinal upset. These timed-release capsules are designed to reduce the possibility of gastrointestinal irritation. There have been rare reports of allergic reactions
","Use of any drug during the first trimester of pregnancy should be avoided if possible. Thus administration of Iron during the first trimester requires definite evidence of Iron deficiency where inadequate diet calls for supplementary Zinc and Folic acid is justified during the remainder of the pregnancy.
","Care should be taken in patients who may develop Iron overloads, such as those with haemochromatosis, haemolytic anaemia or red cell aplasia. Failure to respond to treatment may indicate other causes of anaemia and should be further investigated. Iron & Zinc chelate with tetracycline and absorption of all three agents may be impaired. The absorption of Zinc may be reduced in the presence of Iron. Absorption of Iron may be impaired by penicillamine and by antacids. Such potential interactions can be reduced by separating the administration of each product by several hours. In patients with renal failure a risk of Zinc accumulation could exist.
",,"Iron overdosage is dangerous, particularly in children and requires immediate attention. Gastric lavage should be carried out in the early stages, or if this is not possible vomiting should be induced. These procedures should not be undertaken where signs of the corrosive effects of zinc are present. Give oral desferrioxamine (2 gm for a child or 5 gm for an adult) and demulcent. If serum Iron levels at 4 hours or more post-ingestion are over 5mg/l in a child or 8 mg/l in adults, or if the patient is in shock of coma, intravenous desferrioxamine should be used. Zinc Sulphate in gross over dosage is corrosive. Symptoms are those of gastrointestinal irritation leading in severe cases to haemorrhage, corrosion of the mucosa and possible later stricture formation. Gastric lavage or emesis should be avoided. Demulcents such as milk should be given. Chelating agents such as Dimercaprol, Penicillamine or Edetic Acid have been recommended.
Symptomatic and supportive measures should be given as required. The timed-release capsule presentation may delay excessive absorption of Iron and Zinc and allow more time for initiation of appropriate counter-measure.
",,,"Protected from light and moisture, store below 30˚C. Keep out of reach of children.
",9
+466,Ferrous Sulfate + Folic Acid,ferrous-sulfate-folic-acid-466,,Iron & Vitamin Combined preparations,Iron and folic acid deficiency in pregnancy,"This capsule is a haematinic preparation for the treatment and prophylaxis of iron and folic acid deficiency, especially during pregnancy and lactation.
","Iron & Vitamin Combined preparations
","Iron is an essential constituent of the body, being necessary for haemoglobin formation and for the oxidative processes of living tissues. Iron is primarily absorbed from the duodenum and upper jejunum. The ferrous salt form is absorbed three times more readily than the ferric salt form. The adult male has a requirement of only 13 µg/kg per day (about 1 mg), whereas the menstruating female requires about 21 µg/kg per day (about 1.4 mg). In the last two trimesters of pregnancy, requirements increase to about 80 µg/kg per day (5 to 6 mg). Folic acid is an important factor in cell division and without it, division stops. Adequate folic acid is required for normal erythropoiesis. Deficiency of Folic Acid causes megaloblastic anaemia
","1 (one) capsule a day, throughout pregnancy and lactation. Some patients may need a higher dose because of dietary or other factors.
",,"The absorption of both iron salts and tetracyclines is diminished when they are taken concomitantly by mouth. The absorption of iron salts may also be decreased by magnesium trisilicate-containing antacid.
","Contraindicated in patients receiving repeated blood transfusions or in patients with anaemias not produced by iron deficiency unless iron deficiency is also present.
","Because iron salts are astringent, gastrointestinal irritation may occur. Nausea and epigastric pain are dose related.
",,"Iron chelates with antacid and tetracycline and absorption of all these may be impaired if taken concurrently. However, the administration of tetracycline during pregnancy is contraindicated.
",,"Symptoms of overdosage with iron salts include epigastric pain, nausea and vomiting, haematemesis and circulatory collapse. In severe cases encephalopathy, acute hepatic necrosis and acute renal failure may develop after a latent period. The timed release capsule presentation of ferrous sulfate may delay excessive absorption of iron and allow more time for the initiation of appropriate counter measures. Treatment consists of gastric lavage followed by the introduction of 5 gm desferrioxamine into the stomach. Serum iron levels should be monitored, in severe cases intravenous desferrioxamine should be given together with supportive and symptomatic measures as required.
",,,"Do not store above 25°C temperature, keep away from light and wet place. Keep out of reach of children.
",10
+465,Ferrous Sulfate,ferrous-sulfate-465,,Oral Iron preparations,Anaemia,"Ferrous Sulfate is indicated in the treatment and prevention of iron deficiency anaemia and anaemia of pregnancy where routine administration of iron is necessary.
","Oral Iron preparations
",,"Adult-
+
+- Initial therapeutic dose: 3-4½ teaspoonful daily in divided doses or as prescribed by the physician.
+- Maintenance dose: 1½ teaspoonful daily, but if needed up to 1.8g (9 teaspoonful) daily can be given.
+
+Children-
+
+- Under 1 year: ¼ th teaspoonful thrice daily or as directed by physician
+- 1-5 years: 1 teaspoonful thrice daily
+- 6-12 years: 1½ teaspoonful twice daily.
+
+Mix with water or fruit juice to avoid temporary staining of teeth. Do not mix with milk.
",,"Absorption of iron salt and Tetracycline is diminished when taken concomitantly by mouth. If treatment with both drugs is required iron salt should be given 3 hours before or 2 hours after Tetracycline. Absorption of iron is also decreased in the presence of antacids or when taken with tea.
","Iron therapy is contraindicated in haemachromatosis and haemosiderosis.It should not be given to patients receiving repeated blood transfusion or with anaemia not produced by iron deficiency.
","Therapeutic doses of iron may cause gastrointestinal symptoms like diarrhoea, nausea and vomiting. Although iron is better absorbed between meals, side effects can be reduced by taking it with or immediately after food. Continuous administration may sometimes cause constipation. Iron containing liquid medication may cause temporary staining of teeth (this is less likely when diluted).
",,"Should be administered with caution when given to patients with iron storage or iron absorption disease, haemoglobinopathies or existing gastrointestinal disease.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",8
+464,Ferrous Gluconate,ferrous-gluconate-464,,Oral Iron preparations,Iron deficiency anemia,"Iron-deficiency anemia.
","Oral Iron preparations
","Ferrous gluconate is used in the prevention and treatment of iron-deficiency anaemia. It replaces iron found in haemoglobin, myoglobin and enzymes. It also allows transportation of oxygen via haemoglobin.
","Iron-deficiency anaemia:
+
+- Adult: 60 mg bid up to 60 mg 4 times daily. Prevention: 60 mg daily.
+- Child: Severe: 4-6 mg/kg/day in 3 divided doses; Mild to moderate: 3 mg/kg/day in 1-2 divided doses. Prevention: 1-2 mg/ kg/ day.
+
+Should be taken on an empty stomach. Best taken on an empty stomach. May be taken with meals to reduce GI discomfort.
",,"Concurrent admin with antacids/ H2 antagonists may reduce absorption of iron. Chloramphenicol may delay response to iron. Iron may reduce the absorption of levodopa, methyldopa and penicillamine when given together. Absorption may be reduced when used with quinolones or tetracyclines. Concurrent admin with vitamin C may increase iron absorption.
","Haemochromatosis, haemolytic anemia.
","GI symptoms e.g. stomach cramping, constipation, nausea, vomiting, dark stools, heartburn, diarrhea, teeth staining, urine discoloration.
","Pregnancy Category- A. Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
","Avoid in patients with peptic ulcer, enteritis, or ulcerative colitis and those who receive frequent blood transfusions. Not to be used in premature infants until the vitamin E stores (deficient at birth) are replenished. Avoid prolonged treatment (>6 mth) except in patients with continuous menorrhagia or bleeding.
",,"Overdose may lead to severe iron toxicity, espcially in children.
",,,,10
+463,Ferrous Fumarate + Folic acid,ferrous-fumarate-folic-acid-463,,Iron & Vitamin Combined preparations,Iron deficiency anemia,"For treatment of iron deficiency and prevention of concomitant Folic acid deficiency in adults. For maintenance of maternal haematopoiesis during pregnancy particularly when diet is abnormal or substandard.
","Iron & Vitamin Combined preparations
","Iron is an essential constituent of the body being necessary for haemoglobin formation and for the oxidative processes of living tissues. Iron salts should only be given for the treatment and as prophylaxis of Iron deficiency anaemia. Iron deficiency anaemias are most often the result of chronic haemorrhage, nutritional deficiency, pregnancy or parasite infestation or malabsorption of iron.
A deficiency of Folic acid typically during pregnancy has long been known to cause a megaloblastic anaemia. The vitamin is not storable in the body and the combination of fetal demand during pregnancy and malnutrition can lead to a deficiency, hence anaemia. It has been observed that the rapid production of red blood cells following treatment with iron may deplete body folate if there is inadequate intake; combination of folic acid and ferrous fumerate avoids the complication. Iron and Folic acid are absorbed in the proximal small intestine particularly the duodenum. Ferrous Fumerate & Folic acid supplements replenish iron deficiency. Thereby arresting the anaemia process. Absorbed iron is taken upto the bone marrow's tissues that form blood cells where it is used to synthesize haemoglobin.
","In anaemia: The usual dose is one tablet or capsule daily.
In severe or refractory iron deficiency anaemia: The usual dose is one tablet or capsule twice daily may be given.
In Pregnancy, it is recommended that the dose should be started at the first antenatal consultation and continued until 3 months after delivery.
",,"When Ferrous Fumerate & Folic acid combination and Tetracycline are taken concomitantly, absorption of both drugs are reduced. Concurrent administration of antacid may reduce absorption of iron. Serum anticonvulsant levels may be reduced by administration of folate.
","This is contraindicated in patients with pernicious anaemia and anaemia other than those due to iron deficiency. The nature and causes of anaemia should be established. Absorption of Ferrous Fumerate & Folic acid is inhibited by Magnesium trisillicate and Antacid containing carbonate.
","Gastric distress, abdominal cramps, diarrhoea, allergic reaction.
","There is no contraindication in pregnancy and lactation.
","Administration of Ferrous Fumerate & Folic acid during the first trimester of pregnancy may be undesirable. Very few pregnant women are not protected by physiological doses of Folic acid. If anaemia is developed despite prophylaxis with Ferrous Fumerate & Folic acid, patients should be investigated further. Some postgastrectomy patients show poor absorption of iron. Care is needed when treating patients with peptic ulcer.
",,,,,,9
+462,Ferrous Fumarate,ferrous-fumarate-462,,Oral Iron preparations,Iron deficiency anemia,"Ferrous Fumarate is used to prevent or treat iron deficiency anaemia. The prevention of iron deficiency during pregnancy usually requires a combination of iron and folic acid. Iron is usually found in foods and is necessary for the normal development of red blood cells. A lack of iron affects the development ... Read more
Ferrous Fumarate is used to prevent or treat iron deficiency anaemia. The prevention of iron deficiency during pregnancy usually requires a combination of iron and folic acid. Iron is usually found in foods and is necessary for the normal development of red blood cells. A lack of iron affects the development of the red blood cells and causes a reduction in the number of red blood cells found in the body (iron deficiency anaemia).
","Oral Iron preparations
","Ferrous fumarate is an iron preparation that is used in the prevention and treatment of iron deficiency. The amount of elemental iron is 330 mg/g of ferrous fumarate.
","Iron-deficiency anemia:
+
+- Adult: Usual dose range: Up to 600 mg daily. May increase up to 1.2 g daily if necessary.
+- Child: Preterm neonate: 0.6-2.4 ml / kg daily; up to 6 yr: 2.5-5 ml bid.
+
+Should be taken on an empty stomach. Best taken on an empty stomach. May be taken with meals to reduce GI discomfort.
",,"Oral absorption of iron may be increased when taken with ascorbic acid. May reduce the absorption of quinolones and tetracyclines when taken concurrently via the oral route. Concurrent admin with antacids may reduce the absorption of ferrous fumarate from the GI tract. May reduce the absorption of penicillamine in the gut when taken concurrently.
","Patients with a known hypersensitivity to any of the ingredients. Hemochroma
","Like all medicines, Ferrous Fumarate Tablets can sometimes cause side effects, although not everybody gets them. They might be:
+
+- Heartburn
+- Feeling sick or being sick
+- Diarrhoea or constipation.
+
+Also, you might find your stools are darker in color after you have taken this medicine. This is quite commonly seen with all iron preparations and is normal.
","Pregnancy Category- Not Classified. FDA has not yet classified the drug into a specified pregnancy category
","Patients with intestinal strictures and diverticular disease. May worsen diarrhoea in patients with inflammatory bowel disease. May cause constipation and faecal impaction in elderly. Avoid prolonged admin (>6 mth) except in patients with continued bleeding, menorrhagia or repeated pregnancies. Not for routine use in treatment of haemolytic anaemia unless an iron-deficient state exists. Parenteral iron should not be used concurrently with oral iron treatment. Avoid use in patients receiving repeated blood tranfusions. Pregnancy.
",,"Symptoms: Nausea, vomiting, abdominal pain, diarrhoea, haematemesis and rectal bleeding. Hypotension, coma and hepatocellular necrosis may occur later.
Treatment: Empty stomach contents by gastric lavage within 1 hr of ingestion. In severe toxicity, IV desferrioxamine may be given. Whole bowel irrigation may also be considered in severe poisoning.
",,,,10
+492,Fluticasone Propionate (Nasal Spray),fluticasone-propionate-nasal-spray-492,https://medex.com.bd/attachments/8qt428XLAMklvgBzN4ITAvKXeAcxTC/fluticasone-propionate-nasal-spray-prescribing-information,Fluocinolone & Combined Preparations,Rhinitis,"Fluticasone Propionate is indicated for-
+
+- The prophylaxis and treatment of seasonal allergic rhinitis including hay fever and perennial rhinitis.
+- It has potent anti-inflammatory activity on the nasal mucosa without detectable systemic activity.
+
","Fluocinolone & Combined Preparations, Nasal Steroid Preparations
","Following topical administration into the nasal mucosa, Fluticasone propionate produces anti-inflammatory and vasoconstrictor effects. The exact mechanism of these actions remains unknown but may involve a reduction in the following: number of mediator cells (basophil, leukocytes and mast cells) at the epithelial level, number of eosinophils, the sensitivity of sensory nerves to mechanical stimuli, secretory response to cholinergic receptor stimulation, and fibroblast activity. Other mechanisms may involve - inhibition of capillary dilation and permeability, stabilization of lysosomal membranes and subsequent prevention of release of proteolytic enzymes.
","Adults & children over 12 years: 2 sprays in each nostril once a day preferably in the morning. In some cases 2 sprays into each nostril twice daily, not exceeding 4 sprays.
Children under 12 years (4-11 years): 1 spray in each nostril once a day. The maximum total daily dosage should not exceed 4 sprays. For perennial rhinitis in children, there are insufficient clinical data to recommend its use.
Children below 4 years: The safety and effectiveness of Fluticasone Propionate nasal spray in children below 4 years of age have not been established.
Patients should use Fluticasone Propionate Nasal Spray at regular intervals as directed since its effectiveness depends on its regular use. Or as directed by the physician.
","How to use the Nasal Spray-
+
+- Shake the bottle gently and remove the dust cover.
+- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
+- Gently blow the nose to clear the nostrils.
+- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
+- Breathe out through your mouth.
+- Repeat the above steps in the same/ other nostril for consecutive doses.
+
+Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-
+
+- Remove the dust cover.
+- Gently pull off the nasal applicator.
+- Wash the applicator and dust cover in warm water.
+- Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
+- Gently push the applicator back on the top of the bottle and re-fix the dust cover.
+
",,"Fluticasone Propionate nasal spray is contraindicated in patients with a hypersensitivity to any of its ingredients.
","Fluticasone Propionate nasal spray is absorbed less into the rest of the body, therefore fewer side effects are seen. With the nasal spray, drying of the nose and throat, unpleasant taste and smell and an increase in the incidence of nosebleeds may occur.
","There are no adequate and well-controlled studies in pregnant women. Fluticasone Propionate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Fluticasone Propionate is excreted in human breast milk. Because other corticosteroids are excreted in human milk, caution should be exercised when Fluticasone Propionate nasal spray is administered to a nursing woman.
","Rare instances of wheezing, nasal septum perforation, cataracts, glaucoma and increased intraocular pressure have been reported following the intranasal application of corticosteroids, including Fluticasone Propionate. Although systemic effects have been minimal with recommended doses of Fluticasone Propionate nasal spray. Potential risk increases with larger doses. Therefore, larger than recommended doses of Fluticasone Propionate nasal spray should be avoided.
",,,,,"Keep all medicines out of reach of the children. Store in a cool and dry place protected from light.
",10
+1643,Fluticasone Propionate (Inhaler),fluticasone-propionate-inhaler-1643,https://medex.com.bd/attachments/C6vCn8Rz4hpmsF41dIuTCicUVjtWJ9/fluticasone-propionate-inhaler-prescribing-information,Fluocinolone & Combined Preparations,Asthma,"Fluticasone Propionate HFA is an inhaled corticosteroid (ICS) indicated for: Maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older.
","Fluocinolone & Combined Preparations, Respiratory corticosteroids
","Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Fluticasone propionate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is 18 times that of dexamethasone, almost twice that of beclomethasone-17-monopropionate (BMP), the active metabolite of beclomethasone dipropionate, and over 3 times that of budesonide. Data from the McKenzie vasoconstrictor assay in man are consistent with these results. The clinical significance of these findings is unknown.
Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation. These anti-inflammatory actions of corticosteroids contribute to their efficacy in asthma.
Though effective for the treatment of asthma, corticosteroids do not affect asthma symptoms immediately. Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment. When corticosteroids are discontinued, asthma stability may persist for several days or longer.
Trials in subjects with asthma have shown a favorable ratio between topical anti-inflammatory activity and systemic corticosteroid effects with recommended doses of orally inhaled fluticasone propionate. This is explained by a combination of a relatively high local anti-inflammatory effect, negligible oral systemic bioavailability (<1%), and the minimal pharmacological activity of the only metabolite detected in man.
","Adult and adolescent patients aged 12 Years and older: The starting dosage is based on previous asthma therapy and asthma severity, including consideration of patients’ current control of asthma symptoms and risk of future exacerbation. The recommended starting dosage for patients aged 12 years and older who are not on an inhaled corticosteroid (ICS) is 88 mcg twice daily, approximately 12 hours apart. For other patients, and for patients who do not respond adequately to the starting dosage after 2 weeks of therapy, higher dosages may provide additional asthma control. The maximum recommended dosage for patients aged 12 years and older is 880 mcg twice daily.
Pediatric patients aged 4 to 11 years: The recommended dosage for patients aged 4 to 11 years is 88 mcg twice daily, approximately 12 hours apart.
","Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.
Following simple steps can help to use Inhaler effectively (According to ""
National Asthma Guidelines for Medical Practitioners"" published by Asthma Association):
+
+- Take off the cap.
+- Shake the inhaler (at least six times) vigorously before each use.
+- If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
+- Breathe out as full as comfortably possible & hold the inhaler upright.
+- Place the actuator into mouth between the teeth and close lips around the mouthpiece.
+- While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
+- Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
+- If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
+- After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
+- Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.
+
+
Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.
","Inhibitors of Cytochrome P450 3A4: Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with Fluticasone Propionate HFA is not recommended because increased systemic corticosteroid adverse effects may occur.
Ritonavir: A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations. During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression.
Ketoconazole: Coadministration of orally inhaled fluticasone propionate (1,000 mcg) and ketoconazole (200 mg once daily) resulted in a 1.9-fold increase in plasma fluticasone propionate exposure and a 45% decrease in plasma cortisol area under the curve (AUC), but had no effect on urinary excretion of cortisol.
","The use of Fluticasone Propionate Inhaler is contraindicated in the following conditions: Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Hypersensitivity to any of the ingredients.
","Most common adverse reactions (incidence >3%) are upper respiratory tract infection or inflammation, throat irritation, sinusitis, dysphonia, candidiasis, cough, bronchitis, and headache.
","There are insufficient data on the use of Fluticasone propionate HFA in pregnant women. There are clinical considerations with the use of Fluticasone propionate HFA in pregnant women. There are no available data on the presence of fluticasone propionate in human milk, the effects on the breastfed child, or the effects on milk production. Other corticosteroids have been detected in human milk.
","
+- Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk.
+- Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infections; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
+- Risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to Fluticasone propionate HFA.
+- Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue Fluticasone propionate HFA slowly.
+- Assess for decrease in bone mineral density initially and periodically thereafter.
+- Monitor growth of pediatric patients.
+- Glaucoma and cataracts may occur with long-term use of ICS. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use Fluticasone propionate HFA long term.
+
","Pediatric Use: The safety and effectiveness of Fluticasone Propionate Inhaler in children aged 4 years and older have been established
","Chronic overdosage may result in signs/symptoms of hypercorticism. Inhalation by healthy volunteers of a single dose of 1,760 or 3,520 mcg of fluticasone propionate CFC inhalation aerosol was well tolerated. Fluticasone propionate given by inhalation aerosol at dosages of 1,320 mcg twice daily for 7 to 15 days to healthy human volunteers was also well tolerated. Repeat oral doses up to 80 mg daily for 10 days in healthy volunteers and repeat oral doses up to 20 mg daily for 42 days in subjects were well tolerated. Adverse reactions were of mild or moderate severity, and incidences were similar in active and placebo treatment groups.
",,,"Store at room temperature between 20°C and 25°C. Keep away from light & moisture. Keep out of the reach of children.
",13
+491,Fluticasone Furoate,fluticasone-furoate-491,https://medex.com.bd/attachments/8ol4UmWCSUTZ2hzkyrJFhncEjwcOqK/fluticasone-furoate-inhalation-powder-prescribing-information,Nasal Steroid Preparations,Perennial or seasonal allergic rhinitis,"Fluticasone Furoate Nasal Spray is indicated for the treatment of the symptoms of seasonal and perennial allergic rhinitis in patients aged 2 years and older.
Fluticasone Furoate inhalation powder is indicated for the once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 5 years and older. This is not indicated for the relief of acute bronchospasm.
","Nasal Steroid Preparations
","Fluticasone Furoate is a synthetic trifluorinated corticosteroid with potent anti inflammatory activity. Like other corticosteroids Fluticasone Furoate is found to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g.- histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation.
","Fluticasone Furoate Nasal Spray:
+
+- Adults & Children over 12 years: 2 sprays in each nostril once a day. In some cases 2 sprays into each nostril twice daily, not exceeding 4 sprays.
+- Children under 12 years (2-11 Years): 1 spray in each nostril once a day. Patients should use Fluticasone Furoate nasal spray at regular intervals as directed since its effectiveness depends on its regular use.
+- Children (under 2 years of age): There are no data to recommend use of Fluticasone Furoate Nasal Spray for the treatment of seasonal or perennial allergic rhinitis in children under 2 years of age.
+
+
Fluticasone Furoate Inhalation Capsule: should be administered as 1 inhalation once daily by the orally inhaled route. Fluticasone Furoate should be used at the same time every day. Do not use fluticasone furoate more than 1 time every 24 hours.
+
+- Adults and Adolescents Aged 12 Years and Older: The starting dosage for Fluticasone Furoate should be based upon patients' asthma severity.
+- The usual recommended starting dose for adults and adolescents aged 12 years and older not on an inhaled corticosteroid (ICS) is 100 mcg.
+- For other adults and adolescents aged 12 years and older, the starting dose should be based on previous asthma drug therapy and disease severity.
+- For adults and adolescents aged 12 years and older who do not respond to Fluticasone Furoate 100 mcg after 2 weeks of therapy, replacement with Fluticasone Furoate 200 mcg may provide additional asthma control.
+
+If a dosage regimen of Fluticasone Furoate fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, e.g., replacing the current strength of Fluticasone Furoate with a higher strength, initiating an ICS and long- acting beta 2 -agonist (LABA) combination product, or initiating oral corticosteroids, should be considered.
The highest recommended daily dose in adults and adolescents aged 12 years and older is 200 mcg. After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to help reduce the possibility of side effects.
Pediatric Patients Aged 5 to 11 Years: The recommended dosage for children aged 5 to 11 years is 50 mcg administered once daily
","How to use the Nasal Spray-
+
+- Shake the bottle gently and remove the dust cover.
+- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
+- Gently blow the nose to clear the nostrils.
+- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
+- Breathe out through your mouth.
+- Repeat the above steps in the same/ other nostril for consecutive doses.
+
+Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-
+
+- Remove the dust cover.
+- Gently pull off the nasal applicator.
+- Wash the applicator and dust cover in warm water.
+- Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
+- Gently push the applicator back on the top of the bottle and re-fix the dust cover.
+
","Potent inhibitors of cytochrome P450 3A4 (CYP3A4) may increase exposure to Fluticasone Furoate. Coadministration of ritonavir is not recommended. Use caution with coadministration of other potent CYP3A4 inhibitors, such as ketoconazole.
Special instruction: Patients should be instructed that the device must be primed: before first use, and if the cap is left off or if the device does not seem to be working or if the nasal spray has not been used for 30 days or more. In order to prime the device, the nasal spray needs to be shaken vigorously for about 10 seconds with the cap on. The patient must then press the button firmly all the way in, approximately 6 times until a fine mist is seen. Once primed, the patient must shake the nasal spray vigorously each time before use.
","Fluticasone Furoate nasal spray is contraindicated in patients with a hypersensitivity to any of its ingredients.
","Fluticasone Furoate nasal spray is absorbed less into the rest of the body, therefore fewer side effects are seen. With the nasal spray, drying of the nose and an increase in the incidence of nosebleeds may occur.
Most common adverse reactions of Fluticasone Furoate inhalation capsule reported in ≥5% of adult and adolescent subjects are nasopharyngitis, bronchitis, upper respiratory tract infection, and headache. Most common adverse reactions reported in ≥3% of pediatric subjects aged 5 to 11 years are pharyngitis, bronchitis, and viral infection.
","Use in pregnancy: Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Fluticasone Furoate nasal spray should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus.
Use in lactation: It is not known whether Fluticasone Furoate is excreted in human breast milk. However, since other corticosteroids have been detected in human milk, caution should be exercised when Fluticasone Furoate is administered to a nursing woman.
","Rarely, immediate hypersensitivity reactions or contact dermatitis may occur after the administration of Fluticasone Furoate nasal spray. Rare instances of wheezing, nasal septum perforation, cataracts, glaucoma and increased intraocular pressure have been reported following the intranasal application of corticosteroids, including Fluticasone Furoate. Although systemic effects have been minimal with recommended doses of Fluticasone Furoate nasal spray, potential risk increases with larger doses. Therefore, larger than recommended doses of Fluticasone Furoate nasal spray should be avoided.
","Geriatric use: In general, dose selection for the elderly patient should be cautious, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Use in hepatic impairment: Use Fluticasone Furoate with caution in patients with severe hepatic impairment.
Use in renal impairment: No dosage adjustment is required in patients with renal impairment.
",,,,"Store at a temperature not exceeding 30°C. Do not refrigerate. Protect from light and moisture. Keep out of the reach of children.
",12
+490,Flutamide,flutamide-490,https://medex.com.bd/attachments/QbI7aQ1WC8VwTsXkuiiAHAhGEXpEzn/flutamide-prescribing-information,Hormonal Chemotherapy,Prostate carcinoma,"Flutamide is indicated for use in combination with LHRH agonists for the management of locally confined Stage B2-C and Stage D2 metastatic carcinoma of the prostate.
Stage B2-C Prostatic Carcinoma: Treatment with Flutamide ... Read more
Flutamide is indicated for use in combination with LHRH agonists for the management of locally confined Stage B2-C and Stage D2 metastatic carcinoma of the prostate.
Stage B2-C Prostatic Carcinoma: Treatment with Flutamide and the LHRH agonist should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy.
Stage D2 Metastatic Carcinoma: To achieve benefit from treatment, Flutamide should be initiated with the LHRH agonist and continued until progression.
","Hormonal Chemotherapy
","Flutamide is a nonsteroidal 'pure' antiandrogen which acts directly on the target tissues either by blocking androgen uptake or by inhibiting cytoplasmic and nuclear binding of androgen.
","Oral (Adult)-
Palliative treatment of prostatic carcinoma: 250 mg tid preferably at least 3 days before gonadorelin analogue treatment. May be taken with or without food.
",,"Increased prothrombin time in patients on long-term warfarin treatment.
","Hypersensitivity, severe hepatic impairment, pregnancy and lactation.
","Hot flushes, loss of libido, impotence, gynaecomastia, nausea, vomiting, diarrhoea, increased appetite, sleep disturbances, skin reactions, anaemias, headache, dizziness, malaise, anxiety, hypertension, gastric and chest pain, oedema, blurred vision, hepatitis, jaundice, rash, thirst, pruritus, SLE-like syndrome, drowsiness, confusion, depression, nervousness.
","Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Perform liver function tests before starting treatment and at regular intervals. Treatment is not recommended in patients whose ALT values exceed twice the upper limit of normal. Regular assessment of prostate specific antigen level may help to monitor disease progression. Advise patient against discontinuing drug on their own. Exercise caution in patients with cardiac disease.
",,,,,"Store at 25° C.
",10
+489,Flurbiprofen,flurbiprofen-489,https://medex.com.bd/attachments/EU9Y59Agdz1kmAJtvih4OXnveYXMJW/flurbiprofen-prescribing-information,Drugs for Osteoarthritis,Rheumatoid arthritis,"Carefully consider the potential benefits and risks of Flurbiprofen and other treatment options before deciding to use Flurbiprofen . Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Flurbiprofen is indicated:
+
+- For relief of the signs and symptoms of rheumatoid arthritis.
+- For relief of the signs and symptoms of osteoarthritis.
+
","Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Flurbiprofen inhibits prostaglandin synthesis by decreasing the activity of cyclooxygenase resulting in reduced prostaglandin levels. It is also a potent inhibitor of platelet aggregation.
","After observing the response to initial therapy with Flurbiprofen , the dose and frequency should be adjusted to suit an individual patient's needs. For relief of the signs and symptoms of rheumatoid arthritis or osteoarthritis, the recommended starting dose of Flurbiprofen is 200 to 300 mg per day, divided for administration two, three, or four times a day. The largest recommended single dose in a multiple-dose daily regimen is 100 mg.
","Should be taken with food.
","Reduced antihypertensive effect of ACE inhibitors, angiotensin II receptor antagonists and β-blockers. Slight reduction in blood glucose concentration in patients with DM receiving certain antidiabetic agents (e.g. glyburide, metformin). Reduced diuretic effect of furosemide and thiazides. May increase toxicity of lithium and methotrexate. May increase risk of bleeding with antiplatelets, anticoagulants, SSRIs, corticosteroids.
","Known hypersensitivity to flurbiprofen, history of asthma, urticaria, or allergic-type reactions precipitated by aspirin or other NSAIDs, NSAID-related history of GI bleeding or perforation, treatment of perioperative pain in the setting of CABG surgery. Pregnancy (3rd trimester) and lactation.
","Oedema, abdominal pain, constipation, diarrhoea, dyspepsia/heartburn, liver enzyme elevations, flatulence, nausea, vomiting, wt change, headache, nervousness, CNS stimulation (e.g. anxiety), CNS inhibition (e.g. somnolence), rhinitis, vision changes, dizziness/vertigo, tinnitus, signs and symptoms of UTI, rash. Ocular hyperaemia, eye irritation, fibrosis, miosis, mydriasis.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Patients with known CV disease or risk factors for CV disease, fluid retention. Hepatic and renal impairment. Lactation.
",,"Symptoms: Headache, nausea, vomiting, epigastric pain, GI bleeding, diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting and occasionally convulsions, acute renal failure and liver damage.
Management: Supportive and symptomatic treatment. Admin activated charcoal w/in 1 hr after ingestion. In adults, gastric lavage should be considered.
",,,"Store between 15-25° C.
",12
+488,Flurazepam,flurazepam-488,https://medex.com.bd/attachments/erXPkE4LnSs8loUE5j7y0QYdV64Vhk/flurazepam-prescribing-information,Benzodiazepine hypnotics,Insomnia and sleep disturbances,"Flurazepam is indicated in the following conditions-
+
+- Insomnia is characterized by difficulty in falling asleep, frequent nocturnal awakenings or early morning awakenings
+- Recurring insomnia or poor sleeping habits
+- In acute or chronic medical situations requiring restful sleep.
+
","Benzodiazepine hypnotics
","Flurazepam, a benzodiazepine derivative, is a hypnotic agent which does not appear to decrease dream time as measured by rapid eye movements (REM). Furthermore, it decreases sleep latency and number of awakenings for a consequent increase in total sleep time. Flurazepam binds to an allosteric site on GABA-A receptors. Binding potentiates the action of GABA on GABA-A receptors by opening the chloride channel within the receptor, causing chloride influx and hyperpolarization.
","Adult: Usual dosage is 30 mg at bedtime. In some patients, 15 mg may sufficient.
Elderly or debilitated: 15 mg is usually sufficient for a therapeutic response.
Children: Not recommended.
In hepatic and renal impairment: Dosage may need to be reduced in patients with impaired hepatic or renal function.
",,"Flurazepam potentiates other CNS depressants such as alcohol, barbiturates, sedative antidepressants, antihistamines and antipsychotic drugs. Cimetidine moderately prolongs the already long half-life of the active metabolite desalkyl flurazepam. Antacids may delay the absorption of benzodiazepines.
","Patients with known hypersensitivity to benzodiazepines or any other ingredients of the capsule.
","Dizziness, drowsiness, light-headedness, staggering, ataxia have occurred, particularly in elderly or debilitated persons. Severe sedation, lethargy, disorientation and coma have been reported.
","Pregnancy category-C. Flurazepam is contraindicated in pregnant women. Lactating mothers should avoid it.
","Since the risk of the development of oversedation, dizziness, confusion or ataxia increases substantially with larger doses in elderly and debilitated patients, it is recommended that in such patients the dosage should be limited to 15 mg. The usual precautions are indicated for severely depressed patients or those in whom there is any evidence of latent depression; particularly the recognition that suicidal tendencies may be present and protective measures may be necessary. The usual precautions should be observed in patients with chronic pulmonary insufficiency.
",,"Flurazepam overdosage includes somnolence, confusion and coma. Respiration, pulse and blood pressure should be monitored as in all cases of drug overdosage. General supportive measures should be employed, along with immediate gastric lavage.
",,,"Capsules should be stored in a dry place at 20°-25°C temperature.
",11
+486,Fluphenazine Decanoate,fluphenazine-decanoate-486,https://medex.com.bd/attachments/uwlyXfgfgVuyAt5THOVVphRcrCm7qQ/fluphenazine-decanoate-prescribing-information,Phenothiazine drugs,Tourette syndrome,"In the long-term management of psychotic disorders including:
+
+- Schizophrenia
+- Mania and
+- Organic brain syndrome.
+
","Phenothiazine drugs
","Fluphenazine blocks postsynaptic mesolimbic dopaminergic D1 and D2 receptors in the brain; depresses the release of hypothalamic and hypophyseal hormones and is believed to depress the reticular activating system thus affecting basal metabolism, body temperature, wakefulness, vasomotor tone, and emesis.
","Fluphenazine Decanoate by deep intramuscular injection into the gluteal muscle, test dose 12.5 mg (6.25 mg in elderly), then after 4-7 days 12.5-100 mg repeated at intervals of 14-35 days, adjusted according to response; it is not recommended for children.
",,"Fluphenazine reverses antihypertensive effects of Guanethidine, Methyldopa and Clonidine. It also causes lithium toxicity by interacting with it. Antacids may reduce bioavailability of phenothiazines. Additive CNS depressant effects produced with alcohol, barbiturates, hypnotics, sedatives, opiates and antihistamines.
","Fluphenazine Decanoate oily Injection is contraindicated in patients with hypersensitivity to the drug. Also contraindicated in comatose or severely depressed states, blood dyscrasias, liver disease, pregnancy (3rd trimester), lactation.
","The side effects include tardive dyskinesia, sedation, mental confusion; hypotension; hyperprolactinaemia leading to galactorrhoea and amenorrhoea in women; loss of libido, impotence and sterility in males. Also include allergic reactions, cholestatic jaundice, corneal and lens deposists, skin pigmentation. Other potential adverse reactions are agranulocytosis; neuroleptic syndrome.
","The safety for the use of Fluphenazine decanoate during pregnancy has not yet been established; therefore the possible hazards should be weighed against the potential benefits when administering this drug to pregnant patients.
","Special precaution should be practiced in presence of convulsive disorders; hepatic, renal, cerebrovascular, respiratory and cardiovascular diseases. Also precaution should be observed in case of phenochromocytoma; bone marrow suppression; elderly or debilitated patients.
",,,,,"Store at 15-30°C.
",10
+487,Fluphenazine + Nortriptyline,fluphenazine-nortriptyline-487,,Combined anxiolytics & anti-depressant drugs,Gastric problems,"This is indicated in
+
+- Mild to moderate mixed anxiety/depression
+- Emotional disturbance
+- Sleep disorder
+- Gastric problems
+
","Combined anxiolytics & anti-depressant drugs
","Nortriptyline hydrochloride is a tricyclic antidepressant. Nortriptyline inhibits the uptake of norepinephrine and serotonin at nerve terminals. In contrast to its parent compound amitriptyline which is equally potent in inhibiting the uptake of norepinephrine and serotonin, Nortriptyline has a greater effect on norepinephrine reuptake than on serotonin reuptake.
Fluphenazine is a tranquilizer of the phenothiazine type with piperazine side chain. Fluphenazine primarily acts as a neuroleptic drug whose main therapeutic effect is believed to reside in potent dopamine (specially D2) receptor antagonism.
","Adults: One tablet 2 to 3 times daily.
",,"Interactions with barbiturates, alcohol, and narcotic drugs may occur, so central depressants should be administered with caution.
","It is contraindicated in :
+
+- History of gradual epilepsy or organic brain damage
+- Blood dyscrasia
+- Severe cardiac insufficiency
+- Renal or liver damage
+- Patients taking monoamine oxidase inhibitor (MAOI)
+- Younger children
+- Hypersensitivity to any component of the preparation
+
","Tardive dyskinesias have been reported in phenothiazine therapy; usually after prolonged courses given at doses adequately to control psychotic illness. Blood dyscrasia, Malignant Neuroleptic syndrome and sudden death have been reported rarely. Agranulocytosis is a rare but potentially fatal adverse effect of Nortriptyline Hydrochloride.
","The safety in human pregnancy has not been yet established. The use of this drug in lactation is not recommended, as it is excreted in breast milk.
","Precautions should be taken in patients with glaucoma, prostate enlargement, cardiac failure and myocardial infarction, and in concurrent administration with CNS depressants. The drug may impair alertness and abilities to drive a car or operate machinery.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+485,Flupentixol + Melitracen,flupentixol-melitracen-485,https://medex.com.bd/attachments/SX14JCvZZr1FiSPgm3R6nE9VJEConD/flupentixol-melitracen-prescribing-information,Combined anxiolytics & anti-depressant drugs,Psychosis,"Flupentixol and Melitracen tablet is indicated in-
+
+- Anxiety
+- Depression
+- Apathy
+- Psychogenic depression.
+- Depressive neurosses.
+- Masked depression.
+- Psychosomatic affections accompanied by anxiety and apathy.
+- Menopausal depressions.
+- Dysphoria and depression in alcoholics and drug addicts.
+
","Combined anxiolytics & anti-depressant drugs
","This consists of two well known and well proven compounds: flupentixol-a neuroleptic with anxiolytic and antidepressant properties of its own when given in small doses, and melitracen-a bipolar thymoleptic with activating properties in low doses. In combination the compounds render a preparation with antidepressant, anxiolytic and activating properties. Maximal serum concentration is reached in about 4 hours after oral administration of flupentixol and in about 4 hours after oral administration of melitracen. The biological half-life of flupentixol is about 35 hours and that of melitracen is about 19 hours. The combination of flupentixol and melitracen does not seem to influence the pharmacokinetic properties of the individual compounds.
","Adults: Usually 2 tablets orally daily in the morning and noon. In severe cases, the morning dose may be increased to 2 tablets.
Elderly patients: 1 tablet in the morning.
Maintenance dose: Usually 1 tablet orally in the morning. In cases of insomnia or severe restlessness, additional treatment with a sedative in the acute phase is recommended.
",,"This tablet may enhance the response to alcohol, barbiturates and other CNS depressants. Simultaneous administration of MAO-inhibitors may cause hypertensive crises. Neuroleptics and thymoleptics reduce the antihypertensive effect of guanethidine and similar acting compounds and thymoleptics enhance the effects of adrenaline and noradrenaline.
","
+- The immediate recovery phase after myocardial infarction.
+- Defects in bundle-branch conduction.
+- Untreated narrow-angle glaucoma.
+- Acute alcohol, barbiturate and opiate intoxications.
+- This tablet should not be given to patients who have received an MAO-inhibitor within two weeks.
+- Not recommended for excitable or overactive patients since its activating effect may lead to exaggeration of these characteristics.
+
","In the recommended doses side effects are rare. These could be transient restlessness and insomnia.
","This tablet should preferably not be given during pregnancy and lactation.
","If previously the patient has been treated with tranquillizers with sedative effect these should be withdrawn gradually.
",,"In cases of overdosage the symptoms of intoxications by melitracen, especially of anticholinergic nature, dominate. More rarely extrapyramidal symptoms due to flupentixol occur. Symptomatic and Supportive. Gastric lavage should be carried out as soon as possible and activated charcoal may be administered. Measures aimed at supporting the respiratory and cardiovascular systems should be instituted. Epinephrine (adrenaline) must not be used for such patients. Convulsions may be treated with diazepam and extrapyramidal symptoms with biperiden.
",,,"Store at a temperature not exceeding 30°C in a dry place. Protect from light. Keep out of reach of children.
",11
+484,Flupentixol,flupentixol-484,https://medex.com.bd/attachments/aONRddwJ2DDNq6lEuzIHfpKFO5cZcT/flupentixol-prescribing-information,SSRIs & related anti-depressant drugs,Schizophrenia,"Psychoses, Depression with or without anxiety, Psychoses
","SSRIs & related anti-depressant drugs
","Flupentixol is a thioxanthene antipsychotic that inhibits dopamine-mediated effects by blocking postsynaptic dopamine receptors in the CNS.
","Oral-
Depression with or without anxiety:
+
+- Adult: Initially, 1 mg daily increased after 1 wk to 2 mg daily and then to a max of 3 mg daily, last dose should be given not later than 4 p.m. Doses >2 mg should be given in 2 divided doses. Discontinue treatment if there is no improvement within 1 wk of using the max dose.
+- Elderly: Initially, 0.5 mg daily increased after 1 wk to 1 mg daily with the last dose given not later than 4 p.m. Max: 2 mg daily in 2 divided doses.
+
+Psychoses:
+
+- Adult: Initially, 3-9 mg bid, adjusted according to response. Max: 18 mg daily.
+- Elderly: Initial dose: ¼ or ½ of the usual initial dose.
+
+
Intramuscular-
Psychoses:
+
+- Adult: Initially, 20 mg (1 ml of a 2% oily solution) is given as test dose. After at least 7 days and depending on the response, subsequent doses of 20-40 mg may be given at intervals of 2-4 wk. Usual maintenance dose: 50 mg every 4 wk to 300 mg every 2 wk. Up to 400 mg wkly may be used in severe or resistant cases.
+- Elderly: Initial dose: ¼ or ½ of the usual initial dose.
+
","May be taken with or without food.
","May potentiate the adverse effects of drugs with antimuscarinic effects e.g. TCAs. Reduced efficacy of levodopa. Increases adverse extrapyramidal symptoms with dopamine antagonists (metoclopramide and prochlorperazine).
","Hypersensitivity. Extremely excitable and overactive patients; mania; porphyria; coma; preexisting CNS depression; bone-marrow supression; phaeochromocytoma. Lactation.
","Rigidity, tremors, restlessness, tardive dyskinesia, insomnia, dryness of mouth, wt gain, sexual dysfunction, galactorrhoea and menstrual disturbances.
Potentially Fatal: Neuroleptic malignant syndrome (hyperthermia, hypertonicity of skeletal muscles, unconsciousness and autonomic nervous system instability).
","Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus
","Patients with convulsive disorders; advanced hepatic, renal, CV or resp disease; tasks requiring mental alertness; elderly (especially with dementia), and debilitated patients; neuroleptics with sedative effect must be withdrawn gradually; history of angle-closure glaucoma; urinary retention; prostatic hyperplasia; breast cancer, prolactin dependent tumours; parkinsonism; myasthenia gravis; pregnancy; Avoid direct sunlight.
",,,,,"Store below 25° C.
",11
+483,Fluoxetine Hydrochloride,fluoxetine-hydrochloride-483,https://medex.com.bd/attachments/Yjfs5ObQaq64U1frbqUKxRVlkG9fRG/fluoxetine-hydrochloride-prescribing-information,Phenothiazine related drugs,Obsessive-compulsive disorder (OCD),"Fluoxetine is indicated for the treatment of-
+
+- depressive illness
+- bulimia nervosa
+- obsessive compulsive disorder.
+
","Phenothiazine related drugs
","Fluoxetine has been shown to selectively inhibit the reuptake of serotonin at the presynaptic neuronal membrane which causes increased synaptic concentration of serotonin in the CNS. This result in numerous functional changes associated with enhanced serotonergic neurotransmission. Fluoxetine appears to have no effect on the reuptake of norepinephrine and dopamine and does not exhibit anticholinergic, antihistaminic or α1 adrenergic blocking activity at usual therapeutic doses.
","Initial treatment: Recent studies suggest that 20 mg/day of Fluoxetine may be sufficient to obtain satisfactory antidepressant response. Consequently, a dose of 20 mg/day administered in the morning is recommended as the initial dose.
A dose increase may be considered after several weeks if no clinical improvement is observed. Dosage above 20 mg/day, should be administered on a bid schedule (i.e. morning and noon) and should not exceed a maximum dose of 80 mg/day. As with other antidepressants, the full antidepressant effect may be delayed until 4 weeks of treatment or longer. As with many other medications, a lower or less frequent dosage should be used in patients with renal and/or hepatic impairment.
A lower or less frequent dosage should also be considered for patients, such as elderly, with concurrent disease or on multiple medication. A recommended maximum dose for elderly patients is 60 mg per day.
Maintenance treatment: It is generally agreed among expert psychopharmacologists that acute episode of depression requires several months or longer sustained pharmacologic therapy. Fluoxetine is also used in dosage of 60 mg daily for the management of bulimia nervosa.
Use in children: The use of Fluoxetine in children is not recommended as safety and efficacy have not been established.
",,"
+- MAO inhibitors: Sometimes serious fatal reactions have been reported with concomitant use.
+- Antidepressants: There have been greater than two fold increases of previously stable plasma levels of other antidepressants.
+- Lithium: There have been reports of increased or decreased lithium levels when used concomitantly with Fluoxetine.
+- Antipsychotics: Elevation of blood levels of haloperidol and clozapine has been observed in patients receiving concomitant Fluoxetine.
+- Anticonvulsants: Patients on stable dose of phenytoin and carbamazepine have developed elevated plasma anticonvulsant concentrations and clinical anticonvulsant toxicity following initiation of concomitant fluoxetine treatment.
+- CNS active drugs: Caution is advised if concomitant administration of Fluoxetine is required.
+
","Fluoxetine Hydrochloride is contraindicated in patients known to be hypersensitive to it.
Monoamine oxidase inhibitors: There have been reports of serious, sometimes fatal reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs and changes of mental status that include extreme agitation progressing to delirium and coma) in patients receiving Fluoxetine in combination with monoamine oxidase inhibitors (MAOIs), and in patients who have recently discontinued Fluoxetine and are then started on MAOIs. Some cases presented with features resembling neuroleptic malignant syndrome. Therefore, Fluoxetine should not be used in combination with MAOI, or within 14 days of discontinuing therapy with MAOI. Since Fluoxetine and its major metabolites have very long elimination half-lives, at least 5 weeks should be allowed after stopping Fluoxetine and before starting MAOI.
","Gastrointestinal: Nausea, vomiting, dyspepsia, dry mouth, and diarrhoea.
Neurological: Anxiety, nervousness, insomnia/ drowsiness and fatigue.
Others: Excessive sweating, pruritus, skin rashes associated with liver, kidney and lung involvement. It has therefore been advised that Fluoxetine therapy should be discontinued in any patient who develops a skin rash.
","In animal studies, no teratogenicity or harmful effect was found. Because animal reproductive studies are not always predictive of human responses, Fluoxetine should be used in pregnancy only if clearly needed. As Fluoxetine is excreted in human milk, caution should be exercised when Fluoxetine is administered to nursing women.
","As Fluoxetine undergoes hepatic metabolism and renal excretion, it should be used with caution and in reduced doses in patients with impaired hepatic or renal function. Because of its epileptogenic effect, it should be used with caution in patients with epilepsy or a history of such disorders. Fluoxetine may alter glycaemic control and therefore caution is also warranted in diabetic subjects. Depressed patients with suicidal tendencies should be carefully supervised during treatment. Fluoxetine is not usually considered a suitable form of therapy for the depressive component of bipolar (manic depressive) illness as mania may be precipitated.
",,,,,"Protect from light & moisture. Keep in cool & dry place. Store below 30°C. Keep all the medicines out of the reach of children.
",10
+5,Fluorouracil,fluorouracil-5,https://medex.com.bd/attachments/nVm1C2x22ej5DN9PMybVMAjVCst2CK/fluorouracil-prescribing-information,,,"Fluorouracil is indicated alone or in combination for-
+
+- Carcinoma of the colon or rectum
+- Carcinoma of the stomach and exocrine pancreas
+- Carcinoma of the liver
+- Carcinoma of the breast
+- Carcinoma of the bladder
+- Carcinoma of the lung
+- Epithelial ovarian carcinoma
+- Cervical carcinoma.
+
",,"Fluorouracil is inactive as such in mammalian cells but is converted into the active 5-fluorodeoxyuridine monophosphate (FdUMP) by a variety of different metabolic pathways. The drug works by inhibiting the enzyme thymidylate kinase which results in reduced formation of thymidine and thus of DNA. The active metabolite FdUMP appears to form a stable complex with the folate cofactor N-5, 10-methylene tetrahydrofolate which inactivates thymidylate kinase. Fluorouracil as FdUMP is also incorporated into RNA which results in fluorination of RNA. The effect of fluorouracil on living cells is limited mainly to those in the proliferative phase but while cells in the G2 and S phase are most affected there may be effects at any stage of the cell cycle.
","Intravenous 5-fluorouracil can be delivered by rapid intravenous bolus injection or slow infusion. The vial contents can rapidly be injected directly into a peripheral vein, the commonest schedules being: 12-13.5 mg/Kg (500 mg/m2) daily for 5 days repeated at 4-weekly intervals. Slow intravenous infusion requires the drug, to be diluted in 500 ml of dextrose 5% solution, then infused over 2-3 hr on 5 successive days.
For palliative management of cancer: Initial Dose: 12 mg/kg intravenously once daily for 4 successive days. Maximum Dose: 800 mg/day. If no toxicity is observed, 6 mg/kg may be administered on the 6th, 8th, 10th, and 12th day (No therapy is given on days 5, 7, 9, or 11). Discontinue at the end of day 12, even with no apparent toxicity.
Poor risk patients and those who are not in an adequate nutritional state: Initial Dose: 6 mg/kg/day for 3 days. Maximum Dose: 400 mg/day. If no toxicity is observed, 3 mg/kg may be administered on days 5, 7, and 9 (No therapy is to be administered on days 4, 6, or 8). Discontinue at the end of day 9, even with no apparent toxicity.
Maintenance therapy: In instances where toxicity has not been a problem, it is recommended that therapy be continued using either of the following schedules:
+
+- Repeat the dosage of the first course every 30 days after the last day of the previous course, or
+- When the toxic signs resulting from the initial course of therapy have subsided, administer a maintenance dose of 10 to 15 mg/kg/week as a single dose. Maximum Dose: 1g/week .The reaction by the patient to the previous course of therapy should be taken into account and the dosage should be adjusted accordingly.
+
+
Usual adult dose for cervical cancer: In combination with cisplatin 1 gm/m2 IV on day 1. The cycle is repeated every 21 days.
Usual pediatric dose for malignant disease: The manufacturer has reported that the safety and effectiveness of fluorouracil have not been established in children. However, the drug has been used in children following adult guidelines.
Intra-arterial infusion: Fluorouracil has also been given by intra-arterial infusion for adult in doses of 5 to 7.5 mg/kg body weight is dissolved in 20-100 ml of 5% Dextrose solution and administered 10-20 days by using an infusion pump.
Combination with radiation: Usual adult daily dose of 5-10 mg/kg body weight is given in combination with radiation according to systemic administration method or intra-arterial infusion method.
Combination with other anticancer drugs: Fluorouracil is used alone or in combination in the adjuvant treatment of breast and gastro-intestinal cancer, and palliation of inoperable malignant neoplasms, especially those of the gastro-intestinal tract, breast, head and neck, liver, genito-urinary system, and pancreas. It is also used with cyclophosphamide and methotrexate in the combination chemotherapy of breast cancer. A usual adult dose of 5 to 10 mg/kg body weight daily is given in combination with other anticancer drugs every day or intermittently once to twice a week by systemic administration method or intra-arterial infusion method.
",,"Pre-treatment with cimetidine for 4 weeks led to increased plasma concentrations of fluorouracil following intravenous and oral administration in 6 patients. The effect was probably due to a combination of hepatic enzyme inhibition and reduced hepatic blood flow.
","It is contraindicated in patients that are severely debilitated or in patients with bone marrow suppression due to either radiotherapy or chemotherapy. It is likewise contraindicated in pregnant or breastfeeding women. It should also be avoided in patients that do not have malignant illnesses.
","Potentially life-threatening effects: Severe effects from 5-fluorouracil are related to the dosage and duration of therapy.
Cardiac effects: Occasional case reports associating 5-fluorouracil therapy with 'ischemic cardiac events' evidence against the autoimmune phenomenon is the fact that in several cases cardiotoxicity occurred within several hours of the first dose.
Hematological effects: Potentially lethal effects caused by severe hematological toxicity may develop within the first 10 days of treatment being instituted but generally resolves within 3 weeks. At the recommended dose and schedule it is rather uncommon for hematological toxicity to be severe. Any ontribute to severe effects from 5-fluorouracil on the blood-forming cells. Thus extensive prior irradiation or the concomitant use of cytotoxic drugs tend to exacerbate the severity of the hematological side effects of 5-fluorouracil.
Neurological effects: Effects on the central nervous system have been occasionally reported and cerebral ataxia is dose-dependent with an incidence of between 3.1 and 7%. Acute cerebellar syndromes and myelopathy have been described following intrathecal 5-fluorouracil. Neurological syndromes may occur rarely after carotid artery perfusion in head and neck cancer. Other effects Allergic reaction (including difficulty in breathing, closing of the throat, swelling of the lips, tongue, or face, or hives), decreased bone marrow function and blood problems (extreme fatigue, easy bruising or bleeding, black, bloody or tarry stools, or fever, chills, or signs of infection), hand-foot syndrome (tingling, pain, redness, swelling or tenderness of the hands and feet), severe vomiting, diarrhoea, frequent bowel movements or watery stools, or sores in the mouth or throat, or stomach pain or heartburn or black, bloody or tarry stools. Other less serious side effects may include mild to moderate nausea, vomiting or loss of appetite, balance problems, confusion, rash and itching, or temporary hair loss. Conjunctivitis, both acute and chronic can proceed to tear duct stenosis and ectropion following prolonged administration. Very chronic administration, extending beyond 3 months, of low dosage has been associated with low systemic toxicity but includes the possibility of painful and tender hands and feet associated with erythema of the extremities.
","Fluorouracil is contraindicated throughout pregnancy. The literature pertaining to pregnancy and cytotoxic drugs is necessarily limited but it appears in general that risk of teratogenesis diminishes with the advancement of pregnancy. Therefore most cytotoxic drugs are absolutely contraindicated in the first trimester and 5-fluorouracil, used in the first trimester has been reported to cause multiple congenital abnormalities. There are many case reports, however, of pregnancy being conducted successfully with combination chemotherapy being given to the mother during the second and third trimesters. Because of the age of the population and the natural history of the tumors treated, most of the data on long-term follow-up pertain to therapy for leukemias. More data need to be accrued on the subsequent development of neonates before it is certain that any of these compounds are free of late effects.
It is not known whether fluorouracil is excreted in human milk. Because fluorouracil inhibits DNA, RNA and protein synthesis, mothers should not nurse while receiving this drug.
","5-fluorouracil is highly toxic drug with a narrow margin of safety. Therefore patients should be carefully supervised, since therapeutic response is unlikely to occur without some evidence of toxicity. Daily dose should not exceed 1 gram. Treatment should be discontinued promptly when one of the following signs of toxicity appears: Leucopenia (WBC under 3500/mm3). Thrombocytopenia (platelet under 100000/mm3). Stomatitis ( the first small ulceration at the inner margin of the lips is a signal for stopping treatment). Severe diarrhoea (frequent bowel movements and watery stools). Gastro-intestinal ulceration and bleeding.
","Neonates: No dosage recommendations are made for neonates.
Children: Safety and effectiveness in children have not been established.
The elderly: No special precautions are required, doses being adjusted for the patient's weight and height.
","Cases of deliberate overdose are unknown but excessive toxicity because of the hematological effects as described above. There is no specific antidote to 5-fluorouracil toxicity; treatment consists in supportive care. In addition to the hematological toxicity other toxicities will occur with overdose. Sign and symptoms are qualitatively similar to the side effects. Treatment should be performed promptly and appropriate drugs are given to control symptoms of overdose.
",,"5-Fluorouracil is a cytotoxic anticancer drug and, caution should be exercised in handling 5-Fluorouracil. Special, trained personnel should reconstitute the drug. Preparation requires a room reserved for this purpose. The work surface should be covered with disposable plastic-backed absorbent paper. Smoking, eating and drinking are prohibited in the room. The handling staff must have a set of appropriate equipment, particularly long-sleeved coats, protective masks, caps, protective goggles, sterile disposable gloves, worktop protection sheets and waste collection containers and bags. If 5-Fluorouracil solution contacts the skin, wash the skin immediately and thoroughly with soap and water. Following topical exposure, events have included tingling, burning and redness. If 5-Fluorouracil contacts mucous membranes, the membranes should be flashed thoroughly with water. Pregnant women must be warned and avoid handling cytotoxic agents. All broken containers must be treated with the same precautions and regarded as contaminated waste. Contaminated waste is to be disposed of by incineration in rigid containers labeled for this purpose or must be destroyed as per the government rules.
","Store the vial in original carton not exceeding 25℃. Do not refrigerate. Protect from light.
",12
+482,Fluorometholone Acetate,fluorometholone-acetate-482,https://medex.com.bd/attachments/4qqfUS4pphu62GzfBTFtGbCPtCSMq8/fluorometholone-acetate-prescribing-information,Ophthalmic Steroid preparations,Ocular inflammation,"Fluorometholone Acetate ophthalmic suspension is indicated for the treatment of-
+
+- Acute and chronic non-infectious conjunctivitis and keratitis of allergic origin.
+- Non-infectious inflammation of the anterior chamber of the eye (including anterior uveitis, episcleritis and scleritis).
... Read more
Fluorometholone Acetate ophthalmic suspension is indicated for the treatment of-
+
+- Acute and chronic non-infectious conjunctivitis and keratitis of allergic origin.
+- Non-infectious inflammation of the anterior chamber of the eye (including anterior uveitis, episcleritis and scleritis).
+- Post-operative irritative conditions after strabismus, cataract and glaucoma surgery.
+
","Ophthalmic Steroid preparations
","Fluorometholone is a corticosteroid with an excellent anti-inflammatory action with no significant influence on the intraocular pressure. The anti-inflammatory activity of Fluorometholone is at least 40 times stronger than that of Hydrocortisone. Corticosteroids are thought to act by the introduction of phospholipase A2 inhibitory proteins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandin and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. In comparison with other corticosteroids Fluorometholone is more rapidly degraded in tissue and therefore has less effect on the intraocular pressure. The immunosuppressive action of Fluorometholone is less pronounced than that of Dexamethasone.
","1 drop instilled into the conjunctival sac 2-4 times daily. During the initial 24 to 48 hours the dosage may be safely increased to 1 drop every hour. Care should be taken not to discontinue therapy prematurely. Shake well before use.
",,"Specific drug interaction studies have not been conducted with Fluorometholone ophthalmic suspension.
","
+- Hypersensitivity to any ingredient of the formulation.
+- Infectious conjunctivitis or keratitis.
+- Injuries and ulcerous processes of cornea, especially infections caused by virus, bacteria and fungi.
+- Dry eyes, especially keratoconjunctivitis sicca.
+- Glaucoma.
+
","Glaucoma with optic nerve damage, visual acuity or field defects, cataract formation, secondary ocular infection following suppression of host immunity, perforation of the globe.
","Safety of the use of topical steroids during pregnancy and lactation has not been established. Fluorometholone ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
","Shake well before using. If this product is used for 10 days or longer, intraocular pressure should be monitored.
",,,,,"Store in a cool, dry place and protected from light. Keep out of the reach of children. Discard the container 4 weeks after opening.
",10
+1217,Fluorometholone + Tetrahydrozoline,fluorometholone-tetrahydrozoline-1217,https://medex.com.bd/attachments/1DrJpQviqPLty4enYwgQiOzz54ucf8/fluorometholone-tetrahydrozoline-prescribing-information,Ophthalmic Steroid preparations,Scleritis,"This eye drops is indicated in acute allergic, noninfectious conjunctivitis & keratitis, severe swelling & hyperaemia, noninfectious inflammation of the anterior segment of the eye (including anterior uveitis, episcleritis & scleritis) and post-operative conditions.
","Ophthalmic Steroid preparations
","Fluorometholone is thought to act by the induction of phospholipase A2 inhibitory proteins which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. On the other hand, Tetrahydrozoline is an alpha agonist which constricts the conjunctival blood vessels and thereby relieves the redness of the eye.
","Use in adult: Instill 1 drop into the conjunctival sac 2-3 times daily. The dose may be increased for severe and adult patient to 1 drop hourly for first one to two days.
Use in children: Safety & effectiveness in children below 2 years of age have not been established.
",,,"It is contraindicated in infectious conjunctivitis or keratitis, injuries or ulcerous processes of the cornea, glaucoma, diseases associated with stromal damage of the cornea or sclera & dry eyes.
","Mild burning sensation, reversible increase in intraocular pressure, reactive hyperemia, cataract & corneal defects, glaucoma, systemic effects (chronic use).
","There are no adequate and well-controlled studies of Fluorometholone & Tetrahydrozoline in pregnancy or while breast-feeding. Therefore, this combination should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.
","Avoid prolonged use. This preparation should be used after a careful risk benefit evaluation in case of patients with severe blood circulation diseases, metabolic disturbances, under treatment with MAOIs & other potentially hypertensive drugs, history of cataract, herpes simplex infection, rhinitis sicca.
",,"When the product is used as directed, there is almost no likelihood of an overdose. No information on overdosage with fluorometholone is available. Overdosage with fluorometholone is unlikely to cause acute problems. The symptoms of acute overdosage with tetryzoline are CNS, cardiac and psychiatric disturbances, mydriasis, cyanosis and fever. CNS functions may be inhibited under certain circumstances.
The following measures are possible in case of accidental ingestion and the occurrence of symptoms of intoxication: administration of activated charcoal, gastric lavage, artificial ventilation with oxygen, use of phentolamine to lower blood pressure (5 mg in saline solution, given i.v.). Vasopressors are contraindicated. Antipyretic and anticonvulsive therapy can be administered as necessary.
",,,"Should not be used after the date marked ""EXP"" on the pack. This must be kept out of the reach and sight of children.
",10
+1216,Fluorometholone + Gentamicin,fluorometholone-gentamicin-1216,,Ophthalmic steroid - antibiotic combined preparations,Ocular inflammation,"Inflammation associated with infections in the anterior segment of the eye due to bacteria susceptible to Gentamicin it is also indicated in postoperative infection.
","Ophthalmic steroid - antibiotic combined preparations
","Gentamicin belongs to the group of aminoglycoside antibiotics. It covers a broad spectrum of gram-positive and gram-negative pathogens, including Pseudomonas aeruginosa, Staphylococci, Haemophilus influenzae H. aegypticus, Klebsiella, Enterobacteria, Proteus, Escherichia coli, Shigella and Salmonella. It inhibits specifically bacterial protein synthesis. Fluorometholone is a synthetic fluorinated corticosteroid possessing anti-inflammatory properties. The combination brings concomitantly the bacterial treatment or prophylaxis and the anti-inflammatory effect. In addition, the presence of gentamicin protects from a risk of potential aggravation of a bacterial infection due to the steroid.
","Sterile Ophthalmic Suspension:
+
+- Bacterial infection: The dosage depends on the severity of the disease. The application of 1 drop 5 times daily into the conjunctival sac of the affected eye is recommended. In severe cases the dosage can be increased up to 1 drop per hour for 1 to 2 days.
+- Ocular postoperative infection: 1 drop 4 times daily into the conjunctival sac for 1 week. Then a reduced application frequency is recommended for the remaining part of the treatment.
+
+Sterile Eye Ointment:
+
+- Bacterial infection: Apply 3-4 times daily into the affected eye.
+- Ocular postoperative infection: To support the therapy with Ophthalmic Suspension during the night apply ointment before retiring.
+
",,,"
+- Hypersensitivity to any of the components. Injuries and ulceration of the cornea. Viral infections (e.g. Herpes simplex, Vaccinia) or mycosis.
+- Eye tuberculosis.
+- Glaucoma.
+
","A transient burning sensation may occur after instillation. Rare: Hypersensitivity reactions including eczema of the eyelid and puncture keratitis. Prolonged use of topical steroids may delay wound healing, increase of IOP, develop cataract and cause thinning of cornea & sclera.
","No controlled studies in humans are available. Administration during pregnancy and lactation is therefore not recommended, except for compelling reasons.
","
+- Steroids can mask, activate or aggravate ocular infections.
+- Long-term treatment with steroid may enhance thinning of cornea and sclera and rarely perforation of the cornea has been reported.
+- In case no improvement is observed after 7-8 days of treatment, other therapeutical means should be considered.
+- Patients experiencing blurred vision after application of the product, particularly the ointment, should refrain from driving vehicles or operating machinery.
+- Contact lenses should be removed before each application.
+
",,,,,"Store in a cool and dry place, protect from light. Do not use longer than 30 days after first opening. Keep out of reach of children.
",9
+551,Fluormetholone + Neomycin Sulphate,fluormetholone-neomycin-sulphate-551,https://medex.com.bd/attachments/dH1XtuF3RHesoEkzA88p6yjjZnNmJ4/fluormetholone-neomycin-sulphate-prescribing-information,Ophthalmic steroid - antibiotic combined preparations,Ocular inflammation,"This ophthalmic solution is used for the treatment of conjunctivitis (sticky eyes) due to organisms sensitive to neomycin. This may be used for the treatment of infections at the front of the eye by bacteria sensitive to the antibiotic neomycin. This can be used following removal of something ... Read more
This ophthalmic solution is used for the treatment of conjunctivitis (sticky eyes) due to organisms sensitive to neomycin. This may be used for the treatment of infections at the front of the eye by bacteria sensitive to the antibiotic neomycin. This can be used following removal of something from your eye, as well as before and after surgery, where there is a possibility of infection with susceptible organisms.
","Ophthalmic steroid - antibiotic combined preparations
","There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Their primary target is the cytosolic glucocorticoid receptor. After binding the receptor the newly formed receptor-ligand complex translocates itself into the cell nucleus, where it binds to many glucocorticoid response elements (GRE) in the promoter region of the target genes. The DNA bound receptor then interacts with basic transcription factors, causing the increase in expression of specific target genes.
Like other aminoglycoside antibiotic drugs, neomycin inhibits bacterial ribosomes by binding to the 30S ribosomal subunit of susceptible bacteria and disrupting the translational machinery of bacterial protein synthesis. Bacterial translation is normally initiated by the mRNA binding to the 30S ribosomal subunit and subsequent binding with 50S subunit for elongation.
","The usual dose for adults is one to two drops in eye two to four times a day. During the first 24 to 48 hours, the dose may be safely increased to one drop every hour or as directed by physician.
","You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it. Apply your eye drops in the following way:
+
+- Wash your hands. Shake the bottle well before use. Tilt your head back and look at the ceiling.
+- Gently pull the lower eyelid down until there is a small pocket.
+- Turn the bottle upside down and squeeze it to release one or two drops into each eye that needs treatment.
+- Let go of the lower lid, and close your eye. Press your finger against the corner of your eye (the side where your eye meets your nose) for one minute.
+
",,"Do not use this ophthalmic solution:
+
+- If you are hypersensitive (allergic) to fluorometholone or neomycin sulfate or to any of the other ingredients of this preparation.
+- If you have an eye infection (with pus) caused by micro-organisms not sensitive to the antibiotic neomycin;
+- If you have an active viral or fungal infection of the eye;
+- If you have tuberculosis of the eye;
+- If you have glaucoma;
+- If you are pregnant or breastfeeding.
+
","The following side effects may occur: Increased eye pressure (glaucoma), loss of part of the usual field of vision, blurred vision, cataracts (cloudy lens), eye irritation, red eye, eye pain, foreign body sensation, eyelid or eye swelling, itchy or watery eye, ulcers on the surface of the eye, secondary eye infections from fungi or viruses, skin rash, allergic reactions, change in your sense of taste.
","This ophthalmic solution should not be used during pregnancy and breastfeeding. It is unknown whether the active ingredients of this preparation are excreted in breast milk. Therefore it is not recommended for mothers who are breast feeding.
","If you use this ophthalmic solution for a long period of time:
+
+- It may cause the pressure inside your eye (intraocular pressure) to increase which can lead to glaucoma. The pressure in your eye should be regularly measured.
+- It may cause cataracts (cloudy lens), lack of clearness of vision, or a delay in wound healing of the eye.
+- Damage to the front part of the eye (due to a fungal infection), may occur during or after the use of this ophthalmic solution.
+- It may increase the risk of corneal damage, cause thinning of the cornea or small ulcerations in the surface of your eye.
+- It may also suppress the body’s immune response which leads to secondary eye infections.
+
","The safety and efficacy in children aged 2 years or younger has not been established.
",,,,"Store at or below 25°C. Do not freeze. Do not use 30 days after first opening the bottle, even if there is still some liquid remaining.
",11
+481,Fluorescein Sodium,fluorescein-sodium-481,https://medex.com.bd/attachments/ciGtjdG3NYaRgTvlrmzDtWie7fBeUz/fluorescein-sodium-prescribing-information,Preparations for Ophthalmic diagnosis,Fitting of hard contact lenses,"Fluorescein does not stain a normal cornea but conjunctival abrasions are stained yellow or orange, corneal abrasions or ulcers are stained a bright green and foreign bodies are surrounded by a green ring. Fluorescein can be used in diagnostic examinations including Goldmann tonometry and in the fitting of hard contact lenses
","Preparations for Ophthalmic diagnosis
","Fluorescein sodium responds to electromagnetic radiation and light between the wavelengths of 465- 490 nm and fluoresces, i.e., emits light at wavelengths of 520-530 nm. Thus, the hydrocarbon is excited by blue light and emits light that appears yellowish-green. Following intravenous injection of fluorescein sodium in an aqueous solution, the unbound fraction of the fluorescein can be excited with a blue light flash from a fundus camera as it circulates through the ocular vasculature, and the yellowish green fluorescence of the dye is captured by the camera. In the fundus, the fluorescence of the dye demarcates the retinal and/or choroidal vasculature under observation, distinguishing it from adjacent areas/structures.
","Ophthalmic-
Aid in the fitting of hard contact lenses, Detection of corneal lesions and foreign bodies, Diagnostic ophthalmic procedures:
+
+- Adult: Apply 1% or 2% solution as eye drops or as sterile papers impregnated with fluorescein sodium. May also be given in combination with a local anaesthetic: as a 0.25% solution with oxybuprocaine HCl or proxymetacaine HCl.
+
",,"None known
","Acute necrotising pancreatitis (oral fluorescein dilaurate).
","Nausea and vomiting (IV); extravasation is painful; hypersensitivity reactions; transient yellow coloration of skin and urine; staining of the skin, clothing and soft contact lenses.
","Safety for use in pregnancy and lactation has not been established, therefore use only when considered essential by the physician
","Special care should be taken to avoid microbial contamination. Pseudomonas aeruginosa grows well in fluorescein solutions, therefore, a single dose solution is preferred.
",,,,,"Store below 25°C. Do not freeze. Protect from light.
",10
+479,Fluocinolone Acetonide + Neomycin Sulfate,fluocinolone-acetonide-neomycin-sulfate-479,https://medex.com.bd/attachments/ffeLKFoXMGD7eb9pEzyhZrg0OXI0B0/fluocinolone-acetonide-neomycin-sulfate-prescribing-information,Topical Antifungal preparations,Tularaemia,"This cream or ointment are suitable for treating a wide variety of local inflammatory, pruritic and allergic disorders of the skin. This is particularly suitable for topical application in:
+
+- Eczema and dermatitis: Atopic eczema, seborrhoeic eczema, discoid eczema, otitis externa, contact dermatitis, neurodermatitis.
... Read more
This cream or ointment are suitable for treating a wide variety of local inflammatory, pruritic and allergic disorders of the skin. This is particularly suitable for topical application in:
+
+- Eczema and dermatitis: Atopic eczema, seborrhoeic eczema, discoid eczema, otitis externa, contact dermatitis, neurodermatitis.
+- Prurigo, Psoriasis, lichen planus. Discoid lupus erythematosus.
+
+This is indicated for inflammatory dermatoses, where secondary bacterial infection is present or likely to occur.
","Fluocinolone & Combined Preparations, Topical Antifungal preparations
","Fluocinolone acetonide is a corticosteroid primarily used in dermatology to reduce skin inflammation and relieve itching. It is a synthetic hydrocortisone derivative. Fluocinolone acetonide was also found to strongly potentiate TGF-β-associated chondrogenesis of bone marrow mesenchymal stem/progenitor cells, by increasing the levels of collagen type II by more than 100 fold compared to the widely used dexamethasone.
Neomycin Sulfate actively transported across the bacterial cell membrane, binds to a specific receptor protein on the 30 S subunit of bacterial ribosomes, and interferes with an initiation complex between mRNA (messenger RNA) and the 30 S subunit, inhibiting protein synthesis.
","A small quantity of cream is applied lightly up to two or three times a day, and massaged gently and thoroughly into the skin. These recommendations apply to both children and adults, including the elderly.
",,,"Primary infections of the skin and in rosacea, acne, perioral dermatitis, anogenital pruritis and napkin eruption. Also known hypersensitivity to neomycin.
","Side-effects are extremely rare, but as with all topical corticosteroids, patient may show hypersensitivity reaction.
","Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development, including cleft palate intrauterine growth retardation. There may be a small risk of such effects on the human fetus. When topical steroid treatment is necessary, minimize the amount and length of treatment.
","The appropriate anti-infective cover should be given in the presence of viral or fungal infection. Prolonged use should be avoided in conditions where absorption of neomycin is possible. Do not apply to the external auditory canal of patients with perforated eardrums. Long-term continuous topical steroid therapy can produce atrophic skin changes. Do not apply to the face for prolonged periods. Prolonged use or treatment of extensive areas can produce adrenal suppression, especially in infants and children.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+478,Fluocinolone Acetonide + Hydroquinone + Tretinoin,fluocinolone-acetonide-hydroquinone-tretinoin-478,https://medex.com.bd/attachments/FIhXmeYO5QUv8hUmzFms4LGde7R3mm/fluocinolone-acetonide-hydroquinone-tretinoin-prescribing-information,Hydroquinone Preparations,Melasma,"This cream is indicated for the short-term treatment of moderate to severe melasma of the face, after starting the treatment avoid presence of sun. Use a sunscreen of at least SPF 30 or more.
","Hydroquinone Preparations
","This cream contains three active ingredients Fluocinolone Acetonide, Hydroquinone and Tretinoin. All of them are used to treat melasma. However, the mechanism of action of the active ingredients in This cream in the treatment of melasma is unknown but Fluocinolone Acetonide is a corticosteroid for topical dermatological use and is classified therapeutically as an anti-inflammatory. Hydroquinone is classified therapeutically as a depigmenting agent, which may interrupt one or more steps in the tyrosine-tyrosinase pathway of melanin synthesis. Tretinoin is classified therapeutically as a keratolytic agent.
","This cream should be applied once daily at night. It should be applied at least 30 minutes before bedtime. Gently wash the face and neck with a mild cleanser. Rinse and pat the skin dry. Apply a thin film of the cream to the hyperpigmented areas of melasma including about ½ inch of normal-appearing skin surrounding each lesion. Rub lightly and uniformly into the skin. During the day, use sunscreen and wear protective clothing. Avoid sunlight exposure. Patients may use moisturizers and/or cosmetics during the day.
Pediatric Use: The safety and effectiveness of this cream in pediatric patients have not been established.
",,"Avoid use of medicated or abrasive soaps, cleansers, soaps, cosmetics with drying effects, products with high concentration of alcohol, astringent & other irritants or keratolytic drugs. Also avoid concomitant use of medications with photosensitizing effects.
","This cream is contraindicated in individuals with a history of hypersensitivity, allergy or intolerance to this product or any of its components.
","A very few patients may get severe allergic reactions from this cream. They may have trouble breathing or severe asthma attacks. While patients use this cream, skin may develop mild to moderate redness, peeling, burning, dryness or itching.
","Pregnancy Category C. This cream contains the teratogen, tretinoin, which may cause embryo-fetal death, altered fetal growth, congenital malformations and potential neurologic deficits. It is difficult to interpret the animal studies on teratogenicity with this cream, because the availability of the dermal applications in these studies cannot be assured and comparison with clinical dosing is not possible. There are no adequate and well controlled studies in pregnant women. This cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: Corticosteroids, when systemically administered, the drug appear in human milk. It is not known whether topical application of this cream could result in sufficient systemic absorption to produce detectable quantities of Fluocinolone Acetonide, Hydroquinone or Tretinoin in human milk. Because many drugs are secreted in human milk, caution should be exercised when this cream is administered to nursing women.
","This cream contains Hydroquinone and Tretinoin that may cause mild to moderate irritation. Local irritation, such as skin reddening, peeling, mild burning sensation, dryness and pruritus may be expected at the site of application. Transient skin reddening or mild burning sensation does not preclude treatment. If a reaction suggests hypersensitivity or chemical irritation, the use of the medication should be discontinued. This cream also contains the corticosteroid Fluocinolone Acetonide. Systemic absorption of topical corticosteroids can produce reversible Hypothalamic-Pituitary-Adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia and glucosuria can also be produced by systemic absorption of topical corticosteroid while on treatment. If HPA axis suppression is noted, the use of this cream should be discontinued. Recovery of HPA axis function generally occurs upon discontinuation of topical corticosteroids.
",,,,,"Store in a cool & dry place, protected from light. Do not freeze. Keep out of reach of children.
",10
+1822,Fluocinolone Acetonide + Clioquinol,fluocinolone-acetonide-clioquinol-1822,,Topical Antifungal preparations,Psoriasis,"This cream is indicated in inflammatory skin conditions such as eczema, dermatitis or psoriasis that are infected or likely to become infected.
","Fluocinolone & Combined Preparations, Topical Antifungal preparations
","Fluocinolone is a type of medicine called a topical corticosteroid. Corticosteroids are medicines used for reducing inflammation. Inflammation of the skin happens as a result of allergy or irritation of the skin, and is caused by the release of various substances that are important in the immune system. These substances cause blood vessels to widen and result in the irritated area becoming red, swollen, itchy and painful, such as is seen in dermatitis or eczema.
When fluocinolone is applied to the skin it works by acting inside the cells to decrease the release of these inflammatory substances. This reduces swelling, redness and itch.
There is a range of potencies of corticosteroids available for application to the skin. This medicine contains fluocinolone 0.025% and is classed as a potent corticosteroid. It is prescribed to treat various inflammatory skin disorders, such as eczema and dermatitis, that have not responded to milder steroids.
Clioquinol has antifungal and antibacterial actions. It works by preventing the growth and multiplication of the organisms.
The combination of fluocinolone and clioquinol is used to treat inflammatory skin disorders that are either infected or likely to become infected.
This cream is more suitable for moist, weeping areas of skin, while the thicker, more greasy ointment is more suitable for dry, scaly areas of skin.
","This medicine is for external use on the skin only. The cream or ointment should be applied thinly and evenly to the affected area(s). Avoid getting the medicine in the eyes, or in contact with the inside of the mouth or nose. Rinse with cold water if accidental contact occurs. Wash your hands thoroughly after applying this medicine, unless the hands are the area being treated. If your doctor has advised you to use dressings with this medicine, the skin should be cleansed before applying the cream/ointment under a fresh dressing.
",,"This medicine is not known to affect other medicines. However, as with all medicines, it is important to tell your doctor or pharmacist what medicines you are already using, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before using any new medicines while using this one, to make sure that the combination is safe.
If you are using other medicines on the same area of skin it is recommended that you leave several minutes between applying each product. This is to allow each product time to be absorbed and avoid them mixing on the skin.
If you apply moisturisers shortly before or after applying this medicine these can dilute the corticosteroid and potentially make it less effective. Try to apply your moisturisers at a different time of day, or at least 30 minutes before or after this one.
","This cream should not be used in
+
+- Children under one year of age.
+- Allergy to iodine.
+- Primary bacterial skin infections, such as impetigo.
+- Primary fungal skin infections such as thrush, ringworm, athlete's foot.
+- Viral skin infections, such as chickenpox, shingles, cold sores or herpes simplex.
+- Acne.
+- Chronic inflammatory disorder of the facial skin (acne rosacea).
+- Inflammatory rash around the mouth (perioral dermatitis).
+- Itching around the back passage and genitals.
+- Nappy rash.
+- Widespread plaque psoriasis.
+
","Medicines and their possible side effects can affect individual people in different ways. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect. The following side effects are known to be associated with this medicine.
+
+- Skin irritation at site of application, such as burning, itching and redness.
+- Allergic inflammation of the skin (contact dermatitis).
+- Thinning of the skin.
+- Changes in skin pigmentation.
+- Stretch marks (striae).
+- Groupings of fine blood vessels becoming prominent under the skin (telangiectasia).
+
","Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
This medicine should not be used during pregnancy unless considered essential by your doctor. If it is prescribed by your doctor it should not be used on large areas of skin, underneath airtight dressings, or for prolonged periods of time. Consult your doctor for further information.
This medicine should not be used during breastfeeding unless considered essential by your doctor. If it is prescribed by your doctor it should not be used on large areas of skin, underneath airtight dressings or for prolonged periods of time. If it is applied to the breasts it should be washed off carefully before breastfeeding and then reapplied afterwards.
",,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+508,Fusidic Acid (Ophthalmic),fusidic-acid-ophthalmic-508,https://medex.com.bd/attachments/Auy3uRPvFGAkPCkuTVF9BkCwWzah0m/fusidic-acid-ophthalmic-prescribing-information,Macrolides,Conjunctivitis,"Fusidic Acid is indicated for the topical treatment of superficial bacterial infections of the eye and its adnexa. These may include - bacterial conjunctivitis, blepharoconjunctivitis, blepharitis, sty and keratitis. It may also be used for the management of corneal and conjunctival abrasions and foreign body injuries.
","Macrolides
","Fusidic acid is an antimicrobial agent that inhibits bacterial protein synthesis. Fusidic acid interferes with amino acid transfer from aminoacyl-tRNA to protein on the ribosomes. Fusidic acid is active against a wide range of gram-positive organisms. The sustained release formulation ensures prolonged contact with the conjunctival sac. Fusidic acid penetrates well into the aqueous humor.
","Adults and children (≥ 2 years): Instill one drop in the affected eye(s) twice daily for 7 days. Treatment should be continued for at least 48 hours after the eye returns to normal.
",,"Synergistic action with antistaphylococcal penicillin. Antagonism with ciprofloxacin.
","Fusidic acid viscous eye drops is contraindicated in patients who are hypersensitive to any component of this preparation.
","Fusidic acid is generally associated with very few adverse effects. The most frequently reported treatment-related side-effect is slight stinging or irritation.
","Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Fusidic acid should be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not clear if enough medication from the eye drop would pass into breast milk. Caution should be exercised while giving this eye drops to a nursing mother
","
+- For ophthalmic use only
+- To avoid possible contamination of the drops, do not touch the tube nozzle or to any surface
+- Do not wear contact lenses during the treatment
+- If more than one topical eye drug is being used, the drugs should be administered at least five (5) minutes interval between applications
+
","Use in children: Safety & effectiveness in children below the age of 2 years have not been established.
",,,,"Store between 2-25°C. Discard 1 mth after opening.
",11
+506,Furosemide + Spironolactone,furosemide-spironolactone-506,https://medex.com.bd/attachments/oUlmRDUYPYOVydabIFGxxmTzW0dFQv/furosemide-spironolactone-prescribing-information,Potassium-sparing diuretics,Hypertension,"Frusemide & Spironolactone combination is indicated in-
+
+- Essential hypertension
+- Chronic congestive heart failure
+- Hepatic cirrhosis, with collection of fluid in the abdominal cavity (ascites)
+- Swelling due to excess fluid retention (edema)
+- Hyperaldosteronism
+- Resistant edema associated with secondary hyperaldosteronism
+
","Potassium-sparing diuretics, Potassium-sparing diuretics & Aldosterone antagonists
","Spironolactone (potassium sparing diuretic) and Furosemide (loop diuretic) have different but complementary mechanisms and sites of action. Therefore, when given together they produce additive or synergistic diuretic. The Furosemide component inhibits the Na+/K+/2Cl- co-transporter in the ascending Loop of Henle and blocks the reabsorption of sodium, potassium and chloride ions; thereby increasing the quantity of sodium and the volume of water excreted in the urine. This characteristically induces potassium loss. The spironolactone component inhibits the reabsorption of sodium in exchange for potassium at the distal tubule by antagonising the action of aldosterone so that sodium excretion is greatly favoured and the excess loss of potassium, induced by the Furosemide, is reduced
","Furosemide 20 and spironolactone 50 mg: 1 to 4 tablets daily (20 to 80 mg of Furosemide and 50 to 200 mg of spironolactone) according to the patient’s response.
Furosemide 40 and spironolactone 50 mg: For previously stabilized patients requiring a higher dosage of spironolactone and Furosemide, This tablet can be used at a dose of one to two tablets daily (Furosemide 40 to 80 mg and spironolactone 50 to 100 mg).
Use in children: Spironolactone and Furosemide is not suitable for use in children. Spironolactone and Furosemide may both be excreted more slowly in the elderly.
",,"When taken together with ACE inhibitors or potassium salts there is an increased risk of hyperkalemia. Spironolactone increases the levels of cardiac glycosides such as digoxin in the blood and this may result in digitalis toxicity. Corticosteroids may cause hypokalemia if they are used with Spironolactone. The blood pressure lowering and diuretic effects of Furosemide may be reduced or abolished when used together with indomethacin and possibly other non-steroidal anti-inflammatory drugs (NSAIDs). Furosemide may increase the ototoxicity of aminoglycoside antibiotics. Simultaneous administration of sucralfate and Furosemide may reduce the natriuretic and anti-hypertensive effect of Furosemide.
","Contraindicated in patients with anuria, acute renal insufficiency, rapidly deteriorating or severe impairment of renal function (creatinine clearance <30 ml/min), hyperkalaemia, Addison's disease and in patients who are hypersensitive to Spironolactone, Furosemide or sulphonamides.
","Spironolactone may give rise to headache and drowsiness and gastrointestinal distress, including cramp and diarrhoea. Ataxia, mental confusion, and skin rashes have been reported as side effect. Gynaecomastia is not uncommon and in rare cases breast enlargement may persist. Other endocrine disorders including hirsutism, deepening of the voice, menstrual irregularities and impotence. Transient increase in blood-urea-nitrogen concentrations may occur and mild acidosis has been reported. Spironolactone may cause hyponatremia and hyperkalemia. Excessive diuresis may result in dehydration and reduction in blood volume with circulatory collapse with the possibility of vascular thrombosis and embolism particularly in elderly patients. Serious depletion of potassium and magnesium may lead to cardiac arrhythmias.
","Pregnancy: Spironolactone and its metabolites may cross the placental barrier. The use of spironolactone in pregnant women requires that the anticipated benefit be weighed against the possible hazards to the mother and fetus. Animal teratology studies indicate that Furosemide may cause fetal abnormalities. Therefore, Furosemide should only be used in women in child bearing age when appropriate contraceptive measures are taken or if the potential benefits justify the potential risks to the fetus.
Lactation: Metabolites of Spironolactone have been detected in breast milk. If use of Spironolactone is considered essential, an alternative method of infant feeding should be instituted. Furosemide is excreted in breast milk and breast-feeding should be discontinued if treatment is essential.
","Caution should be taken in patients liable to electrolyte deficiency. This preparation should also be used with caution in diabetes, enlarged prostate, hypotension and in hypovolemia.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+505,Furosemide,furosemide-505,https://medex.com.bd/attachments/g8j3VujsZGZLHpVpowEKqD9uAGhB2e/furosemide-tablets-prescribing-information,Loop diuretics,Tumor lysis syndrome,"Furosemide is indicated in-
+
+- Fluid retention associated with chronic congestive cardiac failure (if diuretic treatment is required).
+- Fluid retention associated with acute congestive cardiac failure.
+- Fluid retention associated with chronic renal failure.
+- Maintenance of fluid excretion in acute renal failure, including that due to pregnancy or burns.
... Read more
Furosemide is indicated in-
+
+- Fluid retention associated with chronic congestive cardiac failure (if diuretic treatment is required).
+- Fluid retention associated with acute congestive cardiac failure.
+- Fluid retention associated with chronic renal failure.
+- Maintenance of fluid excretion in acute renal failure, including that due to pregnancy or burns.
+- Fluid retention associated with nephrotic syndrome (if diuretic treatment is required).
+- Fluid retention associated with liver disease (if necessary to supplement treatment with aldosterone antagonists).
+- Hypertension.
+- Hypertensive crisis (as a supportive measure).
+- Support of forced diuresis.
+
","Loop diuretics
","Furosemide is a monosulphonyl diuretic. It is an effective diuretic that retains its activity even in low glomerular filtration rate (GFR). Furosemide has a distinctive action on renal tubular function. It affects a peak diuresis far greater than that observed with other agents. Other features are (I) prompt onset of action (II) inhibition of sodium and chloride transport in the ascending limb of the loop of Henle and (III) independence of their action from acid-base balance changes. Furosemide acts primarily to inhibit electrolyte reabsorption in the thick ascending limb of the loop of Henle. Furosemide is readily absorbed from the gastrointestinal tract and considerable proportions are bound to plasma proteins. It is rapidly excreted in the urine. With an hour after intravenous injection, its effect is evident in about 5 minutes and last for about 2 hours.
","Furosemide 40 mg Tablet-
Edema:
+
+- Adults: The initial adult dose is 40 mg daily, reduced to 20 mg daily or 40mg on alternate days. In some patients daily doses of 80mg or higher (given in divided doses) may be required. The individually determined single dose should then be given once or twice daily (eg, at 8 am and 2 pm). For resistant edema, 80-120 mg daily. In patients with clinically severe edematous states the dose of furosemide may be carefully titrated up to 600 mg/day. When doses exceeding 80 mg/day are given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable.
+- Children: Neonate: 0.5-2 mg/kg every 12-24 hours (every 24 hours if postmenstrual age under 31 weeks).
+- Child 1 month-12 years: 0.5-2 mg/kg 2-3 times daily (every 24 hours if postmenstrual age less than 31 weeks); higher doses may be required in resistant edema; max. 12 mg/kg daily, not to exceed 80 mg daily.
+- Child 12-18 years:20-40 mg daily, increased in resistant edema to 80-120 mg daily.
+- Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.
+
+Hypertension:
+
+- Adults: The usual initial dose of furosemide for hypertension is 80 mg, usually divided into 40 mg twice a day. Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents.
+- Children: The usual dose is 1 - 3 mg/kg body weight daily up to a maximum dose of 40mg/day.
+- Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.
+
+
Furosemide 250 mg Tablet: For selected patients with advanced chronic renal failure, diuretic therapy may be started with Furosemide orally. If conventional doses (80 to 160 mg orally) fail to produce an adequate diuresis, a single dose of 250 mg is given as a starting dose. If a satisfactory diuresis does not ensue within 4-6 hours, the initial dose may be doubled to 500 mg. The criterion of optimal dosage is a urinary output of at least 2.5 liters per day. A maximum daily dose of 1000 mg should not be exceeded.
Furosemide Syrup: Furosemide Liquid has an exceptionally wide therapeutic range, the effect being proportional to the dosage. Furosemide Liquid is best given as a single dose either daily or on alternate days. The usual initial daily dose is 40 mg. This may require adjustment until the effective dose is achieved as a maintenance dose. In mild cases, 20 mg daily or 40 mg on alternate days may be sufficient, whereas in cases of resistant edema, daily doses of 80 mg and above may be used as one or two daily, or intermittently. Severe cases may require gradual titration of the furosemide dosage up to 600 mg daily. The recommended maximum daily dose of furosemide administration is 1,500 mg.
Furosemide Injection-
Edema:
Adults: Doses of 20-50 mg intramuscularly or intravenously may be given initially. If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours. If doses greater than 50 mg are required it is recommended that they should be given by slow intravenous infusion. The recommended maximum daily dose of furosemide administration is 1,500 mg.
By slow intravenous injection:
+
+- Neonate: 0.5-1 mg/kg every 12-24 hours (every 24 hours if postmenstrual age under 31 weeks).
+- Child 1 month-12 years: 0.5-1 mg/kg repeated every 8 hours as necessary;maximum 2 mg/kg (max. 40 mg) every 8 hours.
+- Child 12-18 years: 20-40 mg repeated every 8 hours as necessary; higher doses may be required in resistant cases.
+
+By continuous intravenous infusion:
+
+- Child 1 month-18 years: 0.1-2 mg/kg/hour (following cardiac surgery, initially 100 micrograms/kg/hour, doubled every 2 hours until urine output exceeds 1 mL/kg/hour).
+- Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.
+
+Hypertension:
+
+- Adults: Doses of 20 to 50 mg intramuscularly or intravenously may be given initially. If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours. If doses greater than 50 mg are required it is recommended that they should be given by slow intravenous infusion. The recommended maximum daily dose of furosemide administration is 1,500 mg. Children: Parenteral doses for children range from 0.5-1.5 mg/kg body weight daily up to a maximum total daily dose of 20 mg.
+- Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.
+
",,"A marked fall in blood pressure may be seen when ACE inhibitors are added to furosemide therapy. Serum lithium levels may be increased when lithium is given concomitantly with furosemide. The toxic effects of nephrotoxic antibiotics may be increased by concomitant administration of potent diuretics such as furosemide.
","Furosemide is contraindicated in anuria, electrolyte deficiency and pre-comatose states associated with liver cirrhosis. Hypersensitivity to furosemide or sulphonamides.
","As with other diuretics, electrolytes and water balance may be disturbed as a result of diuresis of prolonged therapy. Prolonged use can produce alkalosis. It may also cause uric acid retention and may rarely produce acute gout. Furosemide may provoke hyperglycemia and glycosuria.
","Pregnancy category C. Furosemide should be cautiously used in cardiogenic shock complicated by pulmonary oedema and in the first trimester of pregnancy. Blood pressure and pulse during rapid diuresis should be monitored. Caution should be observed in patients liable to electrolyte deficiency. In case of nursing mother, furosemide may inhibit lactation or may pass into breast milk. In that case it should be used with caution.
","Patients with prostatic hypertrophy or impairment of micturition have an increased risk of developing acute retention. A marked fall in blood pressure may be seen when ACE inhibitors are added to furosemide therapy. The toxic effects of nephrotoxic antibiotics may be increased by concomitant administration of potent diuretics such furosemide.
Driving a vehicle or performing other hazardous tasks: Some adverse effects (e.g. an undesirably pronounced fall in blood pressure) may impair the patient's ability to concentrate and react, and, therefore, constitute a risk in situations where these abilities are of special importance (e.g. operating a vehicle or machinery).
",,"Signs and symptoms: The clinical picture in acute or chronic overdose depends primarily on the extent and consequences of electrolyte and fluid loss, e.g. hypovolaemia, dehydration, haemoconcentration, cardiac arrhythmias (including AV block and ventricular fibrillation).
+
Management: No specific antidote to furosemide is known. If ingestion has only just taken place, attempts may be made to limit further systemic absorption of the active ingredient by measures such as gastric lavage or those designed to reduce absorption (e.g. activated charcoal).
",,,"Protect from light. Do not use it later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.
",11
+507,Fucidic Acid + Betamethasone,fucidic-acid-betamethasone-507,https://medex.com.bd/attachments/ypB4TEh3aHp4W5RWBWRxWVz9bDunY6/fucidic-acid-betamethasone-prescribing-information,Betamethasone & Combined preparations,Seborrhoeic dermatitis,"This cream is indicated for the treatment of eczematous dermatoses including atopic eczema, discoid eczema, stasis eczema and seborrhoeic eczema when secondary bacterial infection is confirmed or suspected.
","Betamethasone & Combined preparations
","Betamethasone is a topical fluorinated corticosteroid that has an anti-inflammatory and antipruritic effect. Fusidic acid is a potent topical antibacterial agent which is effective against Staphylococcus aureus, Streptococci, Corynebacteria, Neiserria and certain Clostridia and Bacteroides.
","Apply this cream or ointment to the affected area twice daily. Max duration is 2 weeks.
",,"Fucidic Acid: Synergistic action with antistaphylococcal penicillin. Antagonism with ciprofloxacin.
Betamethasone: Increased hyperglycaemia and hypokalaemia with thiazide diuretics. Increased incidence of peptic ulcer or Gl bleeding with concurrent NSAIDs admin. Response to anticoagulants altered. Dose of antidiabetics and antihypertensives needs to be increased. Decreases serum cone of salicylates and antimuscarinic agents.
Potentially Fatal: Reduced efficacy with concurrent use of carbamazepine, phenytoin, primidone, barbiturates and rifampicin. Enhanced effect in women taking oestrogens or oral contraceptives.
","Skin lesions of viral, fungal or bacterial origin (e.g. herpes or varicella), skin manifestations in relation to TB or syphilis, perioral dermatitis and rosacea, ulcerative condition.
","Hypersensitivity, contact dermatitis, eczema (aggravated condition), skin burning sensation, pruritus, dry skin, application site pain or irritation. Rarely, erythema, urticaria (including rash erythematous and generalised rash), application site swelling or vesicles.
","Topical administration of any corticosteroid to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established; however, topical steroids should not be used extensively in pregnancy, i.e. in large amounts or for prolonged periods
","May increase risk of developing antibiotic resistance. Stasis dermatitis and other skin disease w/ impaired circulation. Not to be used for >7 days if there is no clinical improvement. Avoid prolonged continuous treatment esp in infants and children. Pregnancy and lactation.
",,,,,"Do not store above 25º C. Store in original container.
",10
+504,Fructose,fructose-504,,,,"Fructose is used intravenously as a carbohydrate nutrient. It is converted to liver glycogen and metabolized more rapidly than dextrose without requiring insulin and thus may be used in diabetic patients. Fructose is indicated in patients requiring fluid replacement and caloric feeding. It is better ""nitrogen sparer"" than glucose.
",,,"The volume and rate of infusion of fructose IV solution will depend upon the requirements of the patient and the judgement of attending physician. But the rate of infusion of fructose should not exceed 0.5-1 gm/kg body weight per hour.The usual recommended flow rate for adult is 30-75 drops per minute infused intravenously.
","
+- Check infusion set and infusion solution prior to use.
+- Pull moderately to tear off the protective cover of the Eurocap.
+- Hold lightly the Eurocap but not the bottle body.
+- Open the flow regulator fully and hold the giving set on the top white area, but not the memorane venting region.
+- Insert the spike of the administration set to the Eurocap and fit the connector of the administration set firmly to the needle.
+- Gradually allow the fluid to flow down to the needletip and close.
+- Remove the protective cover of the needle.
+- Locate the venpuncture site and clean the site with an antiseptic solution, and then insert the needle.
+- Securely tape the puncture site.
+- Securely tape the wings and tubing
+- Start infusion while adjusting drip speed.
+
",,"Fructose is contraindicated in certain inborn errors of fructose metabolism, methyl alcohol poisoning, hyperuricemia, liver failure, and lactic acidosis.
","Intravenous administration of fructose may cause lactic acidosis and hyperuricemia.The rapid infusion of fructose results in facial flushing, abdominal pain and sweating.
",,"Fructose should not be given to patients with hereditary fructose intolerance. It should be given with caution to patients with impaired kidney function or severe liver damage. Infusion of fluid should be immediately discontinued if rigor arises for any reason during the process. Do not use if the solution is cloudy, contains particles, or after expiry date.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",7
+1374,Fosfomycin Trometamol,fosfomycin-trometamol-1374,https://medex.com.bd/attachments/w9dzagwLPBUFuObp8xI6tGVfGfI3Sn/fosfomycin-trometamol-prescribing-information,Intracellular antibiotic,Uncomplicated UTI,"It is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women caused by susceptible strains of Escherichia coli and Enterococcus faecalis.
","Intracellular antibiotic
","Fosfomycin has in vitro activity against a broad range of gram-positive and gram-negative aerobic microorganisms, associated with uncomplicated urinary tract infections. Fosfomycin Trometamol is a phosphonic acid derivative. It is a synthetic, broad spectrum, bactericidal antibiotic for oral administration. The bactericidal action of Fosfomycin is due to its inactivation of the enzyme enolpyruvyl transferase, thereby irreversibly blocking the condensation of uridine diphosphate N-acetylglucosamine with p-enolpyruvate, one of the first steps in bacterial cell wall synthesis.
","The recommended dosage for women 18 years of age and older for acute cystitis is one sachet of Fosfomycin with or without food. This medicine should not used in children.
Preparation: At first pour the 100 ml purified water in a glass. Then add full contents of one Fosfomycin sachet into purified water and stir to dissolve completely. Drink full mixture immediately after preparation.
",,"When Fosfomycin is coadministered with metoclopramide, which increases gastrointestinal motility, lowers the serum concentration and urinary excretion of fosfomycin. Other drugs that increase gastrointestinal motility may produce similar effects.
","Fosfomycin is contraindicated in patients with known hypersensitivity to the drug and patients with severe renal insufficiency and patients undergoing haemodialysis.
","In clinical trials, the most frequently reported adverse events occurring in >1% of the study population regardless of drug relationship were: diarrhea 10.4%, headache 10.3%, vaginitis 7.6%, nausea 5.2%, rhinitis 4.5%, back pain 3.0%, dysmenorrhea 2.6%, pharyngitis 2.5%, dizziness 2.3%, abdominal pain 2.2%, pain 2.2%, dyspepsia 1.8%, asthenia 1.7%, and rash 1.4%.The following adverse events occurred in clinical trials at a rate of less than 1%, regardless of drug relationship: abnormal stools, anorexia, constipation, dry mouth, dysuria, ear disorder, fever, flatulence, flu syndrome, hematuria, infection, insomnia, lymphadenopathy, menstrual disorder, migraine, myalgia, nervousness, paresthesia, pruritus, SGPT increased, skin disorder, somnolence, and vomiting.
","Fosfomycin is pregnancy category B. This drug should not be used during pregnancy unless the benefit outweighs the risk. A decision should be made to discontinue breastfeeding or to not administer the drug, taking into account the importance of the drug to the mother.
","Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Fosfomycin. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. Do not use more than one single dose of Fosfomycin to treat a single episode of acute cystitis. Repeated daily doses of Fosfomycin did not improve the clinical success or microbiological eradication rates compared to single dose therapy, but did increase the incidence of adverse events.
",,"When Fosfomycin is coadministered with metoclopramide, which increases gastrointestinal motility, lowers the serum concentration and urinary excretion of fosfomycin. Other drugs that increase gastrointestinal motility may produce similar effects.
",,,"Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light.
",11
+1976,Formoterol Fumarate + Glycopyrrolate + Budesonide,formoterol-fumarate-glycopyrrolate-budesonide-1976,https://medex.com.bd/attachments/MqOmn07TLCXzNjuBGVx3hFNYjchXZZ/formoterol-fumarate-glycopyrrolate-budesonide-prescribing-information,Combined bronchodilators,COPD,"This inhaler is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). This Inhaler is not indicated for the relief of acute bronchospasm or for the treatment of asthma.
","Combined bronchodilators
","This Inhaler is a pressurized metered-dose inhaler that delivers a combination of micronized Budesonide, an inhaled corticosteroid (ICS), micronized glycopyrrolate (an anticholinergic), and micronized formoterol fumarate, an inhaled long-acting beta2-adrenergic agonist (a LABA), for oral inhalation. ICS medicines such as budesonide help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems. Anticholinergic medicines, such as glycopyrrolate, and LABA medicines, such as formoterol fumarate help the muscles around the airways in the lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.
","The recommended dosage of is two inhalations twice daily, once in the morning and again in the evening, by oral inhalation. Do not take more than two inhalations twice daily. After inhalation, rinse mouth with water without swallowing
",,"
+- Strong cytochrome P450 3A4 inhibitors (e.g. ritonavir): Use with caution. May cause systemic corticosteroid effects.
+- Other adrenergic drugs may potentiate effect: Use with caution.
+- Diuretics, xanthine derivatives or steroids may potentiate hypokalemia or ECG changes. Use with caution.
+- Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of formoterol fumarate on cardiovascular system.
+- Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm.
+- Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administration of this spray with other anticholinergic-containing drugs.
+
","This is contraindicated in patients who have demonstrated hypersensitivity to budesonide, glycopyrrolate, formoterol, or any of the excipients.
","Serious asthma-related events-hospitalizations, intubations, death, Candida albicans infection, increased risk of pneumonia, immunosuppression and risk of infections, hypercorticism and adrenal suppression, paradoxical bronchospasm, hypersensitivity reactions including anaphylaxis, cardiovascular effects, reduction in bone mineral density, worsening of narrow-angle glaucoma and cataracts, worsening of urinary retention
","There are no adequate and well-controlled studies with this inhaler or with two of its individual components, Glycopyrrolate or Formoterol Fumarate, in pregnant women to inform a drug-associated risk. There are no available data on the effects of this inhaler on the breastfed child or on milk production. Budesonide, like other ICS, is present in human milk. There are no available data on the presence of Glycopyrrolate or Formoterol Fumarate in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this inhaler and any potential adverse effects on the breastfed child from this inhaler or from the underlying maternal condition.
","The safety and efficacy of this inhaler in patients with asthma have not been established. this inhaler is not indicated for the treatment of asthma. This inhaler has not been studied in patients with acutely deteriorating COPD. The use of this inhaler in this setting is not appropriate. This inhaler should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. This inhaler has not been studied in the relief of acute symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled short-acting beta2-agonist. When beginning treatment with this inhaler, patients who have been taking inhaled, short-acting beta2-agonists on a regular basis (e.g., four times a day) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief of acute respiratory symptoms. When prescribing this inhaler, the healthcare provider should also prescribe an inhaled, short acting beta 2-agonist and instruct the patient on how it should be used. Increasing inhaled beta 2-agonist use is a signal of deteriorating disease for which prompt medical attention is indicated.
The daily dosage of this inhaler should not be increased beyond the recommended dose. As with other inhaled drugs containing beta2-adrenergic agents, this inhaler should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medications containing LABA, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.
Patients using this inhaler should not use another medicine containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason.
this inhaler contains budesonide, an ICS. Localized infections of the mouth and pharynx with Candida albicans have occurred in subjects treated with orally inhaled drug products containing budesonide. When such an infection develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while treatment with this inhaler continues.
Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap.
Patients who are using drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids.
Particular care is needed for patients who have been transferred from systemically active corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients during and after transfer from systemic corticosteroids to less systemically available ICS. Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible.
Effects of budesonide on the HPA axis are not observed with the therapeutic doses of budesonide in this inhaler. However, exceeding the recommended dosage or co-administration with a strong cytochrome P450 3A4 (CYP3A4) inhibitor may result in HPA dysfunction.
It is possible that systemic corticosteroid effects, such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients who are sensitive to these effects. If such effects occur, appropriate therapy should be initiated as needed.
Caution should be exercised when considering the co-administration of this inhaler with long-term ketoconazole, and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) because adverse effects related to increased systemic exposure to budesonide may occur.
As with other inhaled therapies, this inhaler can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with this inhaler, it should be treated immediately with an inhaled, short-acting bronchodilator; this inhaler should be discontinued immediately and alternative therapy should be instituted.
Immediate hypersensitivity reactions have been reported after administration of Budesonide, Glycopyrrolate or Formoterol Fumarate, the components of this inhaler. If signs suggesting allergic reactions occur, in particular, angioedema (including difficulties in breathing or swallowing, swelling of tongue, lips, and face), urticaria, or skin rash, this inhaler should be stopped at once and alternative treatment should be considered.
Formoterol fumarate, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and also cardiac arrhythmias, such as supraventricular tachycardia and extrasystoles. If such effects occur, this inhaler may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiographic changes, such as flattening of the Twave, prolongation of the QTc interval, and ST segment depression, although the clinical significance of these findings is unknown. Therefore, this inhaler should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension
","Hepatic impairment: Budesonide and formoterol fumarate systemic exposure may increase in patients with severe hepatic impairment. Monitor patients for signs of increased drug exposure.
Renal impairment: In patients with severe renal impairment, use should be considered only if the potential benefit of the treatment outweighs the risk.
Pediatric Use: This is not indicated for use in children. The safety and effectiveness of this spray have not been established in pediatric patients.
Geriatric Use: Based on available data, no adjustment of the dosage of This in geriatric patients is necessary, but greater sensitivity in some older individuals cannot be ruled out.
","No cases of overdose have been reported with this inhaler; therefore, the risks associated with overdosage for the individual components described below apply to this inhaler. Treatment of overdosage consists of discontinuation of this inhaler together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. Cardiac monitoring is recommended in case of overdosage.
Budesonide: If used at excessive doses for prolonged periods, systemic corticosteroid effects, such as hypercorticism may occur.
Glycopyrrolate: High doses of Glycopyrrolate, a component of this inhaler, may lead to anticholinergic signs and symptoms such as nausea, vomiting, dizziness, lightheadedness, blurred vision, increased intraocular pressure (causing pain, vision disturbances or reddening of the eye), obstipation, or difficulties in voiding.
Formoterol Fumarate: An overdose of Formoterol Fumarate would likely lead to an exaggeration of effects that are typical for beta2-agonists: seizures, angina, hypertension, hypotension, tachycardia, atrial and ventricular tachyarrhythmias, nervousness, headache, tremor, palpitations, muscle cramps, nausea, dizziness, sleep disturbances, metabolic acidosis, hyperglycemia, hypokalemia. As with all sympathomimetic medications, cardiac arrest, and even death may be associated with overdosage of Formoterol Fumarate.
",,,"Pressurized canister, do not puncture, break or incinerate even when empty as canister may explode. Avoid exposure to direct sunlight or heat. Clean your inhaler regularly as per direction. Do not store above 30° C. Keep in a dry place. Protect from light and keep out of the reach of children. Keep away from eyes. Discard within three months after removing from the foil pouch. For best results, the canister should be at room temperature before use. Shake well before each use.
",12
+502,Formoterol Fumarate,formoterol-fumarate-502,https://medex.com.bd/attachments/qe6jI1cOZ8sDpeSCkn2yUzRzOYWA8T/formoterol-fumarate-prescribing-information,Long-acting selective β-adrenoceptor stimulants,Emphysema,"Treatment of Asthma: Formoterol Fumarate is indicated for the treatment of asthma and in the prevention of bronchospasm only as concomitant therapy with a long-term asthma control medication, such as an inhaled corticosteroid, in adults and children 5 years of age and ... Read more
Treatment of Asthma: Formoterol Fumarate is indicated for the treatment of asthma and in the prevention of bronchospasm only as concomitant therapy with a long-term asthma control medication, such as an inhaled corticosteroid, in adults and children 5 years of age and older with reversible obstructive airways disease, including patients with symptoms of nocturnal asthma.
Prevention of Exercise-Induced Bronchospasm: Formoterol Fumarate is also indicated for the acute prevention of exercise-induced bronchospasm in adults and children 5 years of age and older, when administered on an occasional, as-needed basis. Use of Formoterol Fumarate as a single agent for the prevention of exercise-induced bronchospasm may be clinically indicated in patients who do not have persistent asthma. In patients with persistent asthma, use of Formoterol Fumarate for the prevention of exercise-induced bronchospasm may be clinically indicated, but the treatment of asthma should include a long-term asthma control medication, such as an inhaled corticosteroid.
Maintenance Treatment of Chronic Obstructive Pulmonary Disease: Formoterol Fumarate is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with Chronic Obstructive Pulmonary Disease including chronic bronchitis and emphysema.
","Long-acting selective β-adrenoceptor stimulants
","Formoterol fumarate is a long-acting β2-adrenergic receptor agonist (β2-agonist). Inhaled formoterol fumarate acts locally in the lung as a bronchodilator. In vitro studies have shown that formoterol has more than 200-fold greater agonist activity at β2-receptors than at β1-receptors. Although β2-receptors are the predominant adrenergic receptors in bronchial smooth muscle and β1-receptors are the predominant receptors in the heart, there are also β2-receptors in the human heart comprising 10%-50% of the total beta-adrenergic receptors. The precise function of these receptors has not been established, but they raise the possibility that even highly selective β2-agonists may have cardiac effects.
The pharmacologic effects of β2-adrenoceptor agonist drugs, including formoterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3', 5'-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
In vitro tests show that formoterol is an inhibitor of the release of mast cell mediators, such as histamine and leukotrienes, from the human lung. Formoterol also inhibits histamine-induced plasma albumin extravasation in anesthetized guinea pigs and inhibits allergen-induced eosinophil influx in dogs with airway hyper-responsiveness. The relevance of these in vitro and animal findings to humans is unknown.
","Inhalation Acute bronchospasm; Reversible airways obstruction:
+
+- As inhalation cap: 12 mcg twice daily, up to 24 meg twice daily in severe cases.
+- As dry powder inhaler: 6 or 12 mcg 1 -2 times/day, up to to 24 mcg twice daily in sever cases. As metered doses from aerosol inhaler: 12 or 24 mcg twice daily.
+
+
Prevention of exercise-induced bronchospasm: 6 or 12 mcg at least 15 mins before exercise. Additional doses may be given 12 hr later.
",,"Concomitant treatment with xanthine derivatives, steroids or diuretics may potentiate a possible hypokalaemic effect of beta-agonists. Increased susceptibility to cardiac arrhythmias in patients treated with digitalis. Concomitant use with quinidine, disopyramide, procainamide, phenothiazines, antihistamines, MAOI or TCAs can prolong the QT-interval and increase the risk of ventricular arrhythmias. L-dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2-sympathomimetics. beta-adrenergic blockers can inhibit the effect of formoterol. Increased risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons.
","Hypersensitivity.
","Common side effects are Viral infection, Bronchitis, Chest infection, Dyspnea , Chest pain, Tremor, Dizziness, Angina, Arrhythmias, Hypo/hypertension, Tachycardia, Hypokalemia, Hyperglycemia, Metabolic acidosis, Headache, Insomnia, Paradoxical bronchospasm, Severe asthma exacerbation
","Pregnancy Category-C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Lactation: Not known if it is excreted in breast milk or not.
","Thyrotoxicosis; severe CV disorders e.g. ischaemic heart disease, tachyarrhythmias or severe heart burn; prolonged QT-interval. DM; pregnancy; lactation; children, do not initiate or increase the dose during an exacerbation. May produce paradoxical bronchospasm.
",,,,,"Prior to dispensing: Store in a refrigerator, 2°C to 8°C
After dispensing to patient: Store at 20°C to 25°C
",10
+501,Fondaparinux Sodium,fondaparinux-sodium-501,https://medex.com.bd/attachments/8d85hGANjQ0aFVqLHSFLq5y4e7g6vq/fondaparinux-sodium-prescribing-information,Parenteral anti-coagulants,Venous thromboembolism,"Prophylaxis Of Deep Vein Thrombosis- Fondaparinux is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):
+
+- In patients undergoing hip fracture surgery, including extended prophylaxis;
+- In patients undergoing hip replacement surgery;
... Read more
Prophylaxis Of Deep Vein Thrombosis- Fondaparinux is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):
+
+- In patients undergoing hip fracture surgery, including extended prophylaxis;
+- In patients undergoing hip replacement surgery;
+- In patients undergoing knee replacement surgery;
+- In patients undergoing abdominal surgery who are at risk for thromboembolic complications.
+
+
Treatment Of Acute Deep Vein Thrombosis: Fondaparinux is indicated for the treatment of acute deep vein thrombosis when administered in conjunction with warfarin sodium.
Treatment Of Acute Pulmonary Embolism: Fondaparinux is indicated for the treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital.
","Parenteral anti-coagulants
","Fondaparinux, a synthetic pentasaccharide, acts as a selective inhibitor of activated factor X. It works by binding selectively to antithrombin III and potentiates the neutralisation of factor Xa. This will interrupt the blood coagulation cascade and inhibit both thrombin formation and thrombus development.
","Superficial vein thrombosis: 2.5 mg once daily for 30-45 days.
Venous thromboembolism:
+
+- 50-100 kg: 7.5 mg once daily;
+- >100 kg: 10 mg once daily.
+- Treatment duration: 5-9 days, or until oral anticoagulation is established.
+
+Prophylaxis of deep vein thrombosis in abdominal and orthopaedic surgery: 2.5 mg once daily, starting 6-8 hr after surgery, continue for at least 5-9 days. In high-risk patients, 6-14 days or up to 32 days in hip fracture.
",,"Increased risk of bleeding with (e.g. desirudin, fibrinolytic drugs, glycoprotein IIb/IIIa-receptor antagonists, heparin, heparinoids or LMWH).
","Hypersensitivity. Active clinically significant bleeding, acute bacterial endocarditis.
","Hip-fracture, hip-replacement, or knee-replacement surgery: Anaemia, fever, nausea, oedema, constipation, rash, vomiting, insomnia, increased wound drainage, hypokalaemia, UTI, dizziness, purpura, hypotension, confusion, bullous eruption, urinary retention, haematoma, major bleeding, diarrhoea, dyspepsia, post-op haemorrhage, and headache. Treatment of venous thromboembolism: Constipation, headache, insomnia, fever, nausea, UTI, and coughing. Abdominal surgery: Post-op wound infection and haemorrhage, fever, surgical site reaction, anaemia, HTN, pneumonia, vomiting.
","Pregnancy Category B. Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
Lactation: Unknown whether drug is excreted in milk; use with caution
","Patient with increased risk of haemorrhage (e.g. congenital or acquired bleeding disorders, history or active Gl ulceration, intracranial haemorrhage, recent brain, spinal or ophth surgery)
",,,,,"Store below 25° C. Do not freeze.
",10
+1177,Follitropin Beta,follitropin-beta-1177,https://medex.com.bd/attachments/CZ9dn6Hb6yxkgPSmvnImRTozQUwEk7/follitropin-beta-prescribing-information,Drugs for Infertility,Ovulation induction,"Follitropin beta injection is indicated for the development of multiple follicles in ovulatory patients participating in an Assisted Reproductive Technology (ART) program. Follitropin beta is also indicated for the induction of ovulation and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure.
","Drugs for Infertility
","Follitropin beta is a human FSH preparation of recombinant DNA origin. It stimulates ovarian follicular growth in women who do not have primary ovarian failure.
","Ovulation induction: IM or SC admin: Initiate with 75 IU daily for up to 14 days, may increase by 37.5 IU at wkly intervals. Once follicular growth or serum estradiol levels indicates an adequate response, administer a single dose of hCG (5,000-10,000 IU) after the last dose to induce ovulation. Withhold hCG if the ovaries are abnormally enlarged or if abdominal pain occurs. Max: 300 IU/day.
Assisted reproductive technologies: IM or SC admin: 150-225 IU /day for at least 1st 4 days of treatment. Adjust dose based on individual ovarian response. Usual maintenance dose: 75-300 IU for 6-12 days; 375-600 IU for poor responders. Max (clinical studies): 600 IU/day. Upon adequate follicular development, a single dose of hCG (5,000-10,000 IU) is administered for final oocyte maturation. Oocyte retrieval can be done 34-36 hr later. Withhold hCG if ovaries are abnormally enlarged on the last day of follicular treatment.
",,"No drug-drug interaction studies have been performed.
","Abnormal genital bleeding of undetermined origin, hormone sensitive malignancies; ovary, breast, uterus, hypothalamus, testes or pituitary gland tumor; ovarian cysts or enlargement not due to the polycystic ovary syndrome; high levels of FSH indicating primary gonadal failure (ovarian or testicular); uncontrolled thyroid or adrenal dysfunction; presence of any cause of infertility other than anovulation; hypersensitivity; pregnancy, lactation.
","Ovarian cysts, mild to severe inj site reactions, headache, mild to moderate OHSS, abdominal pain, GI disturbances. Rarely, severe OHSS, ovarian torsion, thromboembolism, mild systemic allergic reactions.
","Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
","May result in multiple births. Ovarian hyperstimulation syndrome (OHSS), serious pulmonary conditions and thromboembolic events may occur. Evaluate patients for hypothyroidism, adrenocortical deficiency, hyperprolactinaemia, pituitary and hypothalamic tumors before starting therapy.
",,"May lead to OHSS and multiple gestations.
",,,"Store at 2-8°C.
",11
+1595,Follitropin Alfa + Lutropin Alfa,follitropin-alfa-lutropin-alfa-1595,https://medex.com.bd/attachments/VT8vzy0FrQyWpEP5tbOz3uKeWgwCTn/follitropin-alfa-lutropin-alfa-prescribing-information,Drugs for Infertility,Infertility,"This injection is indicated for the stimulation of follicular development in adult women with severe LH and FSH deficiency. In clinical trials, these patients were defined by an endogenous serum LH level < 1.2 IU/L.
","Drugs for Infertility
","This injection is a preparation of recombinant human follicle stimulating hormone (follitropin alfa, r-hFSH) and recombinant human luteinising hormone (lutropin alfa, r-hLH) produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. In clinical trials the efficacy of the combination of follitropin alfa and lutropin alfa has been demonstrated in women with hypogonadotropic hypogonadism. In the stimulation of follicular development in anovulatory women deficient in LH and FSH, the primary effect resulting from administration of lutropin alfa is an increase in oestradiol secretion by the follicles, the growth of which is stimulated by FSH.
In clinical trials, patients with severe FSH and LH deficiency were defined by an endogenous serum LH level < 1.2 IU/L as measured in a central laboratory. However, it should be taken into account that there are variations between LH measurements performed in different laboratories. In these trials the ovulation rate per cycle was 70-75%.
","In LH and FSH deficient women (hypogonadotrophic hypogonadism), the objective of this injection therapy is to develop a single mature Graafian follicle from which the oocyte will be liberated after the administration of human chorionic gonadotrophin (hCG). This injection should be given as a course of daily injections. Since these patients are amenorrhoeic and have low endogenous oestrogen secretion, treatment can commence at any time.
Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and oestrogen response.
A recommended regimen commences with one vial of this injection daily. If less than one vial daily is used, the follicular response may be unsatisfactory because the amount of lutropin alfa may be insufficient.
If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7-14 day intervals and preferably by 37.5-75 IU increments using a licensed follitropin alfa preparation. It may be acceptable to extend the duration of stimulation in any one cycle to up to 5 weeks.
When an optimal response is obtained, a single injection of 250 micrograms of r-hCG or 5,000 IU to 10,000 IU hCG should be administered 24-48 hours after the last this injection. The patient is recommended to have coitus on the day of, and on the day following, hCG administration. Alternatively, intrauterine insemination (IUI) may be performed.
Luteal phase support may be considered since lack of substances with luteotrophic activity (LH/hCG) after ovulation may lead to premature failure of the corpus luteum.
If an excessive response is obtained, treatment should be stopped and hCG withheld. Treatment should recommence in the next cycle at a dose of FSH lower than that of the previous cycle.
","This injection is intended for subcutaneous administration. The first injection should be performed under direct medical supervision. The powder should be reconstituted immediately prior to use with the solvent provided. Self-administration should only be performed by patients who are well motivated, adequately trained and with access to expert advice.
","This injection should not be administered as a mixture with other medicinal products, in the same injection, except follitropin alfa for which studies have shown that co-administration does not significantly alter the activity, stability, pharmacokinetic nor pharmacodynamic properties of the active substances.
","This injection is contraindicated in patients with:
+
+- hypersensitivity to the active substances or to any of the excipients
+- tumours of the hypothalamus and pituitary gland
+- ovarian enlargement or ovarian cyst unrelated to polycystic ovarian disease and of unknown origin
+- gynaecological haemorrhages of unknown origin
+- ovarian, uterine or mammary carcinoma
+
+This injection must not be used when an effective response cannot be obtained, such as:
+
+- primary ovarian failure
+- malformations of sexual organs incompatible with pregnancy
+- fibroid tumours of the uterus incompatible with pregnancy
+
",,"There is no indication for the use of this injection during pregnancy. Data on a limited number of exposed pregnancies indicate no adverse reactions of follitropin alfa and lutropin alfa on pregnancy, embryonal or foetal development, parturition or postnatal development following controlled ovarian stimulation. No teratogenic effect of such gonadotropins has been reported in animal studies. In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of this injection. This not indicated during breast-feeding.
","This injection contains potent gonadotrophic substances capable of causing mild to severe adverse reactions, and should only be used by physicians who are thoroughly familiar with infertility problems and their management.
Gonadotrophin therapy requires a certain time commitment by physicians and supportive health care professionals, as well as the availability of appropriate monitoring facilities. In women, safe and effective use of this injection calls for monitoring of ovarian response with ultrasound, alone or preferably in combination with measurement of serum oestradiol levels, on a regular basis. There may be a degree of interpatient variability in response to FSH/LH administration, with a poor response to FSH/LH in some patients. The lowest effective dose in relation to the treatment objective should be used in women.
","Elderly: There is no relevant indication for the use of this injection in the elderly population. Safety and effectiveness of this medicinal product in elderly patients have not been established.
Renal and hepatic impairment: Safety, efficacy, and pharmacokinetics of this medicinal product in patients with renal or hepatic impairment have not been established.
Paediatric population: There is no relevant use of this medicinal product in the paediatric population.
",,,,"Do not store above 25°C. Store in the original package in order to protect from light.
",11
+500,Follitropin Alfa,follitropin-alfa-500,https://medex.com.bd/attachments/IucNxUZh2tV68XaJfF18OQzn619c8s/follitropin-alfa-prescribing-information,Drugs for Infertility,Spermatogenesis induction,"Women: Follitropin alfa is indicated for the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure. Follitropin alfa is also indicated ... Read more
Women: Follitropin alfa is indicated for the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure. Follitropin alfa is also indicated for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program.
Men: Follitropin alfa for injection is indicated for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.
","Drugs for Infertility
","Follitropin alfa is a human FSH preparation of recombinant DNA origin. It stimulates ovarian follicular growth in women who do not have primary ovarian failure and stimulates spermatogenesis in men with hypogonadotrophic hypogonadism.
","Female infertility: Dose should be individualised. Recommended initial: 75 IU/day; may increase by up to 37.5 IU after 14 days; further increases of the same magnitude may be made every 7 days, if needed. Max: 300 IU/day. If response is appropriate, administer hCG 1 day after the last dose.
Assisted reproductive technologies Initial: 150-225 IU/day for at least 4 days, to be started on day 2 or 3 of cycle, until follicular development is adequate. Adjust dose based on ovarian response. Usual max: 450 IU/day. Once follicular development is adequate, administer hCG to induce final follicular maturation. Withhold hCG if ovaries are abnormally enlarged.
Spermatogenesis induction 150 IU 3 times/week with continued chorionic gonadotrophin for at least 4 mth. Max: 300 IU 3 times/week
",,"Other ovulation stimulating agents (eg hCG, clomiphene citrate) may potentiate the follicular response, concurrent use of GnRH agonist-induced pituitary desensitisation may increase the dosage of Gonal-f needed to elicit an adequate ovarian response.
","Hypersensitivity. Abnormal genital bleeding of undetermined origin, sex hormone sensitive malignancies of the reproductive tract and accessory organs, an organic intracranial lesion e.g. pituitary tumor, ovarian cysts or enlargement of undetermined origin, high levels of FSH indicating primary gonadal failure, uncontrolled thyroid or adrenal dysfunction, pregnancy, lactation.
","Ovarian cysts, mild to severe Inj site reactions, headache, mild to moderate ovarian hyperstimulation syndrome (OHSS), abdominal pain, GI disturbances. Rarely, severe OHSS, ovarian torsion, thromboembolism, mild systemic allergic reactions.
","Pregnancy category X. Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
","May result in multiple births. Ovarian hyperstimulation syndrome, serious pulmonary conditions and thromboembolic events may occur. Evaluate patients for hypothyroidism, adrenocortical deficiency, hyperprolactinaemia, pituitary and hypothalamic tumors before starting therapy.
",,,,,"Store at 2-25° C.
",10
+1410,Follicle Stimulating Hormone [Urofollitropin],follicle-stimulating-hormone-urofollitropin-1410,https://medex.com.bd/attachments/BzBAMCZL4cH3P9nijvKdnmB5S8sVtT/follicle-stimulating-hormone-urofollitropin-prescribing-information,Drugs for Infertility,Ovulation induction,"In the Female:
+
+- Ovulation Induction: FSH administered IM or SC with HCG in a sequential manner, which is indicated for ovulation induction in patients who have previously received pituitary suppression.
+- Multi-follicular Development: During ART FSH administered IM in conjunction with HCG is indicated for multiple follicular developments (controlled ovarian stimulation) during ART cycles in patients who have previously received pituitary suppression.
... Read more
In the Female:
+
+- Ovulation Induction: FSH administered IM or SC with HCG in a sequential manner, which is indicated for ovulation induction in patients who have previously received pituitary suppression.
+- Multi-follicular Development: During ART FSH administered IM in conjunction with HCG is indicated for multiple follicular developments (controlled ovarian stimulation) during ART cycles in patients who have previously received pituitary suppression.
+- Polycystic Ovarian Syndrome (PCOS): Used to treat Polycystic Ovarian Syndrome (PCOS) related infertility
+
+In the Male: Male infertility treatment in combination with HCG Induction of Spermatogenesis in men deficient spermatogenesis due to Hypogonadotrophic-hypogonadism.
","Drugs for Infertility, Trophic Hormones & Related Synthetic Drugs
","FSH is a product containing a highly purified preparation of human follicle stimulating hormone (FSH-HP) extracted from the urine of postmenopausal women. Third generation of urinary gonadotrophins FSH-HP;Use of monoclonal antibodies specific to FSH resulted in further refinements in manufacture, and the production of highly purified (HP) urinary FSH. The presence of LH is less than 0.1% per 75 IU of FSH & Unidentified urinary proteins are less than 5% in Human FSH-HP. FSH consists of two non-covalently linked glycoproteins designated as the alfa and beta subunits. The alfa subunit has 92 amino acids of which two are modified by attachment of carbohydrates. The beta subunit has 111 amino acids of which two are modified by attachment of carbohydrates. FSH is a sterile, lyophilized powder intended for subcutaneous (SC) or intramuscular (IM) injection after reconstitution with sterile 0.9% Sodium Chloride Injection. Each vial of FSH contains 75 International Units (IU) of Follicle Stimulating Hormone (FSH) which is reconstituted with diluents. The in vivo biological activity of Urofollitropin (FSH) for injection, purified is determined by using reference standards calibrated against the First International Standard for follicle- stimulating hormone (FSH, Urofollitropin), Urinary, and Human for Bioassay, National Institute for Biological Standards and Control (NIBSC) at its 46th meeting in 1995. FSH is a glycoprotein that is acidic and water-soluble.
","There are great inter-and intra-individual variations in the response of the ovaries to exogenous gonadotrophins. This makes it impossible to set a uniform dosage scheme. The dosage should, therefore, be adjusted individually depending on the ovarian response. This requires ultrasonography and monitoring of oestradiol levels. There should be consideration to minimize the risk of unwanted ovarian hyperstimulation. FSH can be given either alone, or in combination with a GnRH analogue to prevent premature luteinisation. In the latter case, especially when using a GnRH agonist, a higher total treatment dose of FSH may be required to achieve an adequate follicular response. Clinical experience with FSH is based on up to three treatment cycles in both indications. Overall experience with IVF indicates that in general the treatment success rate remains stable during the first four attempts and gradually declines thereafter.
Ovulation Induction in Women: Starting daily dose of 50 international units (IU) of FSH is administered subcutaneously or intramuscularly for at least the first 7 days. The dose is increased by 25 or 50 international units (IU) at weekly intervals until follicular growth and/or serum estradiol levels indicate an adequate response. When an acceptable pre-ovulatory state is achieved, final oocyte maturation is achieved with 5000 to 10,000 international units (IU) of human chorionic gonadotropin (HCG). The woman and her partner should have intercourse daily, beginning on the day prior to the administration of HCG and until ovulation becomes apparent
Assisted Reproductive Technology (ART): In Women; Starting dose of 150 to 225 international units (IU) of FSH is administered intramuscularly for at least the first 4 days of treatment. Subsequent doses are adjusted based upon ovarian response as determined by ultrasound evaluation of follicular growth and serum estradiol levels. Final oocyte maturation is induced with a dose of 5000-10,000 international units of HCG Oocyte (egg) retrieval is performed 34 to 36 hours later
Polycystic Ovarian Hyperstimulation (PCOS): FSH injections are therefore given each morning as an intramuscular injection. It is best to start with the lowest dose of FSH per day (using 50 IU per day). These doses are used for 4 to 6 days at a time. The ovarian response is determined by measuring oestrogen levels in the blood. When the oestrogen begins to rise, the FSH is successfully growing an egg or eggs. If there is no response to a dose of FSH in 5- 6 days of injections the dose will be increased. The normal dose increments are 75 units, 112 units, 150 units and 225 units per day. Most patients respond with 75 to 150 IU per day. However it is very important that increments are only made cautiously.
Dosage in Male: Induction of Spermatogenesis in Men Pre-treatment with HCG alone (1500 international units (IU) twice weekly) is required. If serum testosterone levels have not normalized after 8 weeks of HCG treatment, the dose may be increased to 3000 international units (IU) twice a week. After normalization of serum testosterone levels, administer 450 international units (IU) per week (225 international units twice weekly or 150 international units (IU) three times weekly) of FSH subcutaneously with the same pre-treatment HCG dose used to normalize testosterone level.
","To prevent painful injections and minimize leakage from the injection site FSH should be slowly administered intramuscularly or subcutaneously. The subcutaneous injection site should be alternated to prevent lipoathrophy. Any unused solution should be discarded. Subcutaneous injection of FSH may be carried out by patient or partner, provided that proper instructions are given by the physician. Self administration of FSH should only be performed by patients who are well-motivated, adequately trained and with access to expert advice.
","No drug/drug interaction studies have been conducted for Urofollitropin in humans
","
+- Tumours of the ovary, breast, uterus, pituitary or hypothalamus
+- Pregnancy or lactation
+- Undiagnosed vaginal bleeding
+- Hypersensitivity to the active substance or to any of the excipients
+- Primary ovarian failure
+- Fibroid tumors of the uterus incompatible with pregnancy
+- Primary testicular failure
+
","FSH sometimes excites the ovaries too much. This may cause pelvic pain or breathing problems. It may also make you urinate less. In rare cases, patients with this problem have had serious lung problems, including fluid in the lungs, troublebreathing, and worsening of asthma blood clots and strokes, severe pelvic pain, chest pain, or abdominal pain, Nausea, Vomiting, Sudden weight gain, Bloating, Trouble, breathing. FSH may cause twins or multiple births. The most common side effects with FSH are headache, vaginal bleeding, nausea, and hot flashes. Sometimes there is a reaction at the spot where you give yourself the injection. This can include bruising, pain, or redness.
","Pregnancy Category X. FSH must not be used during pregnancy and lactation.
","The presence of uncontrolled non gonodalendocrinopathies (e.g. thyroid, adrenal or pituitary disorders) should be excluded
+
+- In pregnancies occurring after induction of ovulation with gonadotrophin preparations, there is an increased risk of multiple gestations (Multiple birth)
+- There has been no reports of hypersensitivity to FSH, but there remains the possibility of anaphylactic responses
+- The first injection of FSH should be performed under direct medical supervision
+- Since infertile women undergoing assisted reproduction, and particularly IVF, often have tubal abnormalities the incidence of ectopic pregnancies might be increased. Early ultrasound confirmation that a pregnancy is intrauterine is therefore important.
+- Rates of pregnancy loss in women undergoing assisted reproduction techniques are higher than in the normal population.
+- Unwanted ovarian hyperstimulation in the treatment of female patients, ultrasonographic assessment of follicular development, and determination of oestradiol levels should be performed prior to treatment and at regular intervals during treatment. Apart from the development of a high number of follicles, oestradiol levels may rise very rapidly, e.g. more than a daily doubling for two or three consecutive days, and possibly reaching excessively high values. The diagnosis of ovarian hyperstimulation may be confirmed by ultrasound examination. If this unwanted ovarian hyperstimulation occurs (i.e. not as part of controlled
+- ovarian hyperstimulation in medically assisted reproduction programs), the administration of FSH should be discontinued. In that case pregnancy should be avoided and HCG must be withheld, because it may induce, in addition to multiple ovulation, the ovarian hyperstimulation syndrome (OHSS).
+- In men, semen analysis is recommended 4 to 6 months after the beginning of treatment in assessing the response
+
",,"No data on acute toxicity of FSH in humans is available, but the acute toxicity of FSH and of urinary gonadotrophin preparations in animal studies has been shown to be very low. Too high a dosage of FSH may lead to hyperstimulation of the ovaries.
",,"To prepare the solution, inject 1 ml of sterile saline for injection into the vial of 75 IU FSH. Do not shake, but gently swirl until the solution is clear. Generally FSH dissolves immediately. Check the liquid in the container; if it is not clear or contains particles, do not use it. For patients requiring a single injection from multiple vials of FSH up to 4 vials can be reconstituted with 1 ml of sterile saline for injection. This can be accomplished by reconstituting a single vial as described above. Then draw the entire contents of the first vial into a syringe and inject the contents into a second vial of lyophilized Urofollitropin. Gently swirl the second vial, once again checking to make sure the solution is clear and free of particles. This step can be repeated with 2 additional vials for a total up to 4 vials (300 IU) of 75 IU FSH.
","Store at 2°C to 8°C (in a refrigerator). Do not keep in deep freeze. Can be stored below 25°C for a maximum of 3 months. Protect from light & keep in dry place .
",13
+498,Folic Acid + Zinc Sulfate Monohydrate,folic-acid-zinc-sulfate-monohydrate-498,,Specific mineral & vitamin combined preparations,Zinc & folic acid deficiency,"This tablet is indicated for the treatment and prophylaxis of Folic Acid and Zinc deficiencies.
","Specific mineral & vitamin combined preparations
","This tablet is a special preparation of Folic Acid & Zinc Sulfate Monohydrate. Zinc is an essential trace element required for human nutrition and involved in a number of body enzyme system. Severe Zinc deficiency causes skin lesion, alopecia, diarrhoea, increased susceptibility of infections, cognitive impairment, etc. Folic Acid is a member of the B-Vitamins group. It is reduced in the body to tetrahydrofolate, which is the coenzyme for various metabolic processes including the synthesis of purine and pyrimidine nucleotides, and hence the synthesis of DNA. It is also involved in some amino acid conversions. Deficiency of Folic Acid may cause megaloblastic anaemia, develops when the dietary intake is inadequate, as in malnutrition, from malabsorption, from increased utilization as in pregnancy of conditions such as haemolytic anaemia, and as a result of administration of folate antagonists.
","Orally 1 tablet daily or as directed by the physician.
",,"A large amount of Calcium decreases the absorption of Zinc. In case of Folic Acid, no drug interactions have been reported.
","Zinc is contraindicated in patients having hypersensitivity to Zinc. Folic Acid is contraindicated in untreated cobalamine deficiency
","Folic Acid & Zinc is well tolerated in the recommended dose. Occasionally gastrointestinal disturbances like abdominal pain, dyspepsia, nausea, vomiting, fever and respiratory distress may occur.
","Recommended during pregnancy & lactation.
",,,"Zinc Sulfate is corrosive in overdose. Symptoms are corrosion and inflammation of the mucous membrane of the mouth and stomach.
",,,"Store at temperature of below 30°C, protect from light & moisture. Keep out of reach of children.
",10
+495,Folic Acid,folic-acid-495,https://medex.com.bd/attachments/uqxON99mSGUACtYOtZWIbRSTQ7eEOE/folic-acid-tablets-5-mg-prescribing-information,Drugs for Megaloblastic Anemia,Nutritional supplement,"Folic acid is indicated for the treatment of-
+
+- Folic acid deficiency
+- Megaloblastic anemia
+- Anemias of nutritional origins, pregnancy, infancy, or childhood.
+
","Drugs for Megaloblastic Anemia, Vitamin-B preparations
","Folic acid, as it is biochemically inactive, is converted to tetrahydrofolic acid and methyltetrahydrofolate by dihydrofolate reductase (DHFR). These folic acid congeners are transported across cells by receptor-mediated endocytosis where they are needed to maintain normal erythropoiesis, synthesize purine and thymidylate nucleic acids, interconvert amino acids, methylate tRNA, and generate and use formate. Using vitamin B12 as a cofactor, folic acid can normalize high homocysteine levels by remethylation of homocysteine to methionine via methionine synthetase.
","Adults-
+
+- Initially: 5 mg daily for 4 months.
+- maintenance: 5 mg every 1-7 days depending on the underlying disease.
+
+Children-
+
+- Up to 1 year: 500 mcg/kg daily.
+- Over 1 year: Same as adult dose.
+
",,"None has been reported.
","Folic acid is contraindicated in patients who have shown previous intolerance to the drug.
","Folic acid is generally well tolerated. Gastro-intestinal disturbances may occur. Hypersensitivity reactions have been reported rarely.
","No special precautions are known.
","It should be used with caution in patients who may have folate dependent tumours. It should never be given alone or in conjunction with inadequate amounts of vitamin B12 for the treatment of undiagnosed megaloblastic anaemia. Although folic acid may produce a haematopoietic response in patients with a megaloblastic anaemia due to vitamin B12 deficiency it should not be given alone in vitamin B12 deficiency states as it may precipitate the onset of subacute combined degeneration of the cord. In elderly people a cobalamin absorption test should be done before long term folate. No harmful results found from short courses of folate.
",,,,,"Store below 30°C in a dry place, away from light. Keep out of the reach of children.
",10
+494,Fluvoxamine Maleate,fluvoxamine-maleate-494,https://medex.com.bd/attachments/FQuCFxSuZpPx7CiP0Hzia8XXugTciB/fluvoxamine-maleate-prescribing-information,SSRIs & related anti-depressant drugs,Obsessive-compulsive disorder (OCD),"Maprotiline Hydrochloride is indicated in-
+
+- Obsessive-Compulsive Disorder
+- Depressive illness
+- Panic Disorder
+- Eating Disorders
+- Chronic Tension Headache
+
","SSRIs & related anti-depressant drugs
","The exact mechanism of action of fluvoxamine has not been fully determined but appears to be linked to its inhibition of CNS neuronal uptake of serotonin. Fluvoxamine blocks the reuptake of serotonin at the serotonin reuptake pump of the neuronal membrane, enhancing the actions of serotonin on 5HT1A autoreceptors. Studies have also demonstrated that fluvoxamine has virtually no affinity for α1- or α2-adrenergic, β-adrenergic, muscarinic, dopamine D2, histamine H1, GABA-benzodiazepine, opiate, 5-HT1, or 5-HT2 receptors, despite having an affinity for binding to σ1 receptors.
","Adults: The recommended starting dose for Fluvoxamine Maleate Tablets in adult patients is 50 mg, administered as a single daily dose at bedtime. In the controlled clinical trials establishing the effectiveness of Fluvoxamine Maleate Tablets in OCD, patients were titrated within a dose range of 100 to 300 mg/day. Consequently, the dose should be increased in 50 mg increments every 4 to 7 days, as tolerated, until the maximum therapeutic benefit is achieved, not to exceed 300 mg per day. It is advisable that a total daily dose of more than 100 mg should be given in two divided doses. If the doses are not equal, the larger dose should be given at bedtime.
Pediatric Population (children and adolescents): The recommended starting dose for Fluvoxamine Maleate Tablets in pediatric populations (ages 8-17 years) is 25 mg, administered as a single daily dose at bedtime. In a controlled clinical trial establishing the effectiveness of Fluvoxamine Maleate Tablets in OCD, pediatric patients (ages 8-17) were titrated within a dose range of 50 to 200 mg/day. Physicians should consider age and gender differences when dosing pediatric patients. The maximum dose in children up to age 11 should not exceed 200 mg/day. Therapeutic effects in female children may be achieved with lower doses. Dose adjustment in adolescents (up to the adult maximum dose of 300 mg) may be indicated to achieve therapeutic benefit. The dose should be increased in 25 mg increments every 4 to 7 days, as tolerated until the maximum therapeutic benefit is achieved. It is advisable that a total daily dose of more than 50 mg should be given in two divided doses. If the two divided doses are not equal, the larger dose should be given at bedtime.
Elderly or Hepatically Impaired Patients: Elderly patients and those with hepatic impairment have been observed to have a decreased clearance of fluvoxamine maleate. Consequently, it may be appropriate to modify the initial dose and the subsequent dose titration for these patient groups.
",,"Drugs Inhibiting or Metabolized by Cytochrome P450: Fluvoxamine inhibits several cytochrome P450 isoenzymes (CYP1A2, CYP2C9, CYP3A4, and CYP2C19).
Carbamazepine: Elevated carbamazepine levels and symptoms of toxicity with coadministration (7.2).
Sumatriptan: Rare postmarketing reports of weakness, hyperreflexia, and incoordination following use of an SSRI and sumatriptan. Monitor appropriately if concomitant treatment is clinically warranted.
Tacrine: Coadministration increased tacrine C max and AUC five- and eight-fold and caused nausea, vomiting, sweating, and diarrhea.
Tricyclic Antidepressants (TCAs): Coadministration significantly increased plasma TCA levels. Use caution; monitor plasma TCA levels; reduce TCA dose if indicated.
Tryptophan: Severe vomiting with coadministration.
Diltiazem: Bradycardia with coadministration.
Propranolol or metoprolol: Reduce dose if coadministered and titrate more cautiously
","Coadministration of tizanidine, thioridazine, alosetron, pimozide.
Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with Fluvoxamine Maleate Tablets or within 14 days of stopping treatment with Fluvoxamine Maleate Tablets. Do not use
Fluvoxamine Maleate Tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start Fluvoxamine Maleate Tablets in a patient who is being treated with linezolid or intravenous methylene blue.
","Most common reactions in controlled trials with adult OCD and depression patients (incidence ≥5% and at least twice that for placebo) were nausea, somnolence, insomnia, asthenia, nervousness, dyspepsia, abnormal ejaculation, sweating, anorexia, tremor, and vomiting. Using the above rule, the following events were also identified: anorgasmia, decreased libido, dry mouth, rhinitis, taste perversion, and urinary frequency in patients with OCD; and agitation, depression, dysmenorrhea, flatulence, hyperkinesia, and rash in pediatric patients with OCD.
","Consider both potential risks and benefits when treating a pregnant woman. Infants exposed to SSRIs late in pregnancy have developed various complications and may be at risk for persistent pulmonary hypertension of the newborn (PPHN). Fluvoxamine is secreted in human breast milk.
","Fluvoxamine Maleate should be used with caution in patients with a history of mania, seizures, suicide, concomitant ECT, cardiac disease, diabetes mellitus, angle-closure glaucoma, history of bleeding disorders (especially gastrointestinal bleeding), hepatic and renal impairment. Fluvoxamine maleate may also impair the performance of skilled tasks (driving).
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+493,Fluvastatin,fluvastatin-493,https://medex.com.bd/attachments/yRv0YV9PuE5xMphR7CgJA7tWhgG1qO/fluvastatin-prescribing-information,Other Anti-anginal & Anti-ischaemic drugs,Obesity,"Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted ... Read more
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate.
","Other Anti-anginal & Anti-ischaemic drugs, Statins
","Fluvastatin acts by competitively inhibiting HMG-CoA reductase, the enzyme for cholesterol synthesis. It reduces total cholesterol, triglycerides, LDL and VLDL concentrations in plasma. It also increases HDL concentrations.
","Oral-Hyperlipidaemias:
+
+- Adult: Initially, 20-40 mg once daily in the evening, may increase at intervals of 4 wk to max 80 mg/day.
+- Child: Heterozygous familial hypercholesterolaemia: 9-16 yr 20 mg once daily. If necessary, may increase dose at 6-wkly intervals to 40 mg bid or 80 mg once daily as modified-release.
+
+May be taken with or without food
",,"Bleeding and increased prothrombin time with coumarin anticoagulants. May increase the risk of myopathy rhabdomyolysis with HIV protease inhibitors, colchicine, bezafibrate, ciprofibrate or niacin (nicotinic acid), ciclosporin and fluconazole. Reduced bioavailability with concomitant rifampicin.
","Acute liver disease or unexplained persistent elevation of serum aminotransferases. Pregnancy and lactation. Avoid admin of two 40 mg conventional cap at one time.
","Headache, nausea, abdominal pain, dyspepsia, diarrhoea, bronchitis, sinusitis, insomnia, fatigue, myopathy, myalgia and UTI. Increased blood creatinine phosphokinase and transaminase.
","Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
","History of liver disease and hereditary muscular disorders; high alcohol intake; patients who undergone major surgery and under immunosuppressive agents. Manage hypothyroidism prior to treatment. Severe renal impairment.
","Mild to moderate renal impairment: No dosage adjustment needed.
","Management: Symptomatic and supportive treatment.
",,,"Store between 15-30° C.
",12
+1460,Fluticasone Propionate + Formoterol Fumarate,fluticasone-propionate-formoterol-fumarate-1460,https://medex.com.bd/attachments/dXFl3XuTpfh7hHcXAsv8133z43TOrl/fluticasone-propionate-formoterol-fumarate-prescribing-information,Respiratory corticosteroids,COPD,"Asthma: This fixed-dose combination of Fluticasone Propionate and Formoterol Fumarate is indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting ß2 agonist) is appropriate:
+
+- For patients not adequately controlled with inhaled corticosteroids and ""as required"" inhaled short-acting ß2 agonist. Or,
... Read more
Asthma: This fixed-dose combination of Fluticasone Propionate and Formoterol Fumarate is indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting ß2 agonist) is appropriate:
+
+- For patients not adequately controlled with inhaled corticosteroids and ""as required"" inhaled short-acting ß2 agonist. Or,
+- For patients already adequately controlled on both an inhaled corticosteroid and a long-acting ß2 agonist.
+
+Fluticasone Propionate 125 mcg and Formoterol Fumarate 5 mcg inhaler are indicated in adults and adolescents aged 12 years and above.
COPD: Fluticasone Propionate and Formoterol Fumarate is recommended when a long-acting ß2 agonist/Inhaled corticosteroid is indicated & patients are unable to use other long-acting ß2 agonist/Inhaled corticosteroid.
Fluticasone Propionate 125 mcg and Formoterol Fumarate 5 mcg inhaler is indicated in adults only.
","Respiratory corticosteroids
","This inhaler (a pressurised inhalation, suspension) which contains two active ingredients:
+
+- Fluticasone propionate which belongs to a group of medicines called steroids. Steroids help to reduce swelling and inflammation in the lungs.
+- Formoterol fumarate dihydrate which belongs to a group of medicines called long-acting beta 2 agonists. Long-acting beta 2 agonists are long-acting bronchodilators which help the airways in your lungs to stay open, making it easier for you to breathe.
+
+Together these two active ingredients help to improve your breathing. It is advised that you should use this medicine every day as directed by your doctor or asthma nurse.
This medicine helps to prevent breathing problems such as asthma and helps to stop you becoming breathless and wheezy. However, it does not work if you are already having an asthma attack i.e. you are already breathless and wheezing. You will need to use a fast acting ‘reliever’ medicine such as salbutamol if this happens.
","Patients will need to be trained on the use of the inhaler and their asthma should be regularly reassessed by a doctor, so that the strength of this inhaler they are receiving remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Patients should be given the strength of this inhaler containing the appropriate Fluticasone Propionate dosage for the severity of their disease.
Asthma:
Fluticasone Propionate 125 mcg & Formoterol Fumarate 5 mcg inhaler only
+
+- The recommended dose for adults and adolescents aged 12 years and above: Two inhalations (puffs) twice daily normally taken in the morning and in the evening.
+- For adults only: The total daily dose can be further increased if asthma still remains poorly controlled by administering the highest strength of this combination product- i.e. Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg inhaler- two inhalations (puffs) twice daily. This highest strength is for use in adults only; it should not be used in adolescents aged 12 years and above.
+- Children under 12 years: No data are available for this strength of this inhaler in children.
+- This inhaler in any strength is not recommended for use in children less than 12 years of age.
+
+Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg inhaler only
+
+- The recommended dose for adults: Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg inhaler- two inhalations (puffs) twice daily normally taken in the morning and in the evening.
+- Adolescents under 18 years and children: No data are available for this strength of this inhaler in children or adolescents. This inhaler in any strength is not recommended for use in children less than 12 years of age.
+- This inhaler 250 microgram/10 microgram per actuation should not be used in adolescents.
+
+
COPD: Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg, two inhalations (puffs) twice daily normally taken in the morning and in the evening.
","Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.
Following simple steps can help to use Inhaler effectively (According to ""
National Asthma Guidelines for Medical Practitioners"" published by Asthma Association):
+
+- Take off the cap.
+- Shake the inhaler (at least six times) vigorously before each use.
+- If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
+- Breathe out as full as comfortably possible & hold the inhaler upright.
+- Place the actuator into mouth between the teeth and close lips around the mouthpiece.
+- While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
+- Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
+- If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
+- After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
+- Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.
+
+
Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.
","No formal drug interaction studies have been performed with this inhaler. Fluticasone Propionate, an individual component of this inhaler, is a substrate of CYP 3A4. The effects of short-term co-administration of strong CYP 3A4 inhibitors (e.g. Ritonavir, Atazanavir, Clarithromycin, Indinavir, Itraconazole, Nelfinavir, Saquinavir, Ketoconazole, Telithromycin) together with this inhaler is of minor clinical relevance, but caution needs to be taken in long-term treatment and co-administration with such drugs should be avoided if possible.
","this inhaler should not be used to treat acute asthma symptoms for which a fast and short-acting bronchodilator is required. Patients should be advised to have their medicine to be used for relief in an acute asthma attack available at all times.
The prophylactic use of this inhaler in exercise-induced asthma has not been studied. For such use, a separate rapid-acting bronchodilator should be considered. Patients should be reminded to take their this inhaler maintenance dose as prescribed, even when asymptomatic. Patients should not be initiated on this inhaler during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma. Serious asthma-related adverse events and exacerbations may occur during treatment with this inhaler. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on this inhaler.
This inhaler should not be used as the first treatment for asthma.
This inhaler should be administered with caution in patients with pulmonary tuberculosis, quiescent tuberculosis or patients with fungal, viral or other infections of the airway. This inhaler should be used with caution in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders, such as ischaemic heart disease, cardiac arrhythmias or severe heart failure. Caution must be observed when treating patients with existing prolongation of the QTc interval. Formoterol itself may induce prolongation of the QTc interval.
As for all ß2 agonists, additional blood sugar controls should be considered in diabetic patients. As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. This inhaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). It is important, therefore, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained.
","Undesirable effects which have been associated with this inhaler during clinical development are given in the table below, listed by system organ class. The following frequency categories form the basis for classification of the undesirable effects as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 < 1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
","Pregnancy: There are limited data on the use of Fluticasone Propionate and FormoterolFumarate, either administered alone or together but administered from separate inhalers, or on the use of this fixed-dose combination, this inhaler in pregnant women. Studies in animals have shown reproductive toxicity. Administration of this inhaler is not recommended during pregnancy, and should only be considered if expected benefit to the mother is greater than any possible risk to the fetus. If this is the case, then the lowest effective dose needed to maintain adequate asthma control should be used.
Breastfeeding: It is not known whether Fluticasone Propionate or FormoterolFumarateare excreted in human breast milk. Therefore, a decision must be made whether to discontinue breastfeeding or to discontinue/abstain from this inhaler therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility: There are no data available on effects on fertility following administration of this inhaler. In animal studies, no effects on fertility have been seen following administration of the individual active substances at clinically relevant doses.
",,"Special patient groups: There is no need to adjust the dose in elderly patients.
Hepatic or renal: There are no data available for use of this inhaler in patients with hepatic or renal impairment.
Paediatric population: It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of inhaled corticosteroid, if possible, to the lowest dose at which effective control of asthma is maintained. In addition, consideration should be given to referring the patient to a paediatric respiratory specialist.
Only limited data are available in respect of the use of this inhaler in children under 12 years of age. This inhaler is not recommended for use in children under 12 years of age until further data become available.
","There are no data available from clinical trials on overdose with this inhaler, however, data on overdose with both single drugs are given below:
FormoterolFumarate: An overdose of Formoterol would likely lead to an exaggeration of effects that are typical for ß2 agonists; in which case the following adverse experiences may occur: angina, hypertension or hypotension, palpitations, tachycardia, arrhythmia, prolonged QTc interval, headache, tremor, nervousness, muscle cramps, dry mouth, insomnia, fatigue, malaise, seizures, metabolic acidosis, hypokalaemia, hyperglycaemia, nausea and vomiting.
Fluticasone Propionate: Acute overdose with Fluticasone Propionate usually does not constitute a clinical problem. The only harmful effect after inhalation of a large amount of the drug over a short period is suppression of hypothalamic pituitary adrenocortical (HPA) axis function. HPA axis function usually recovers in a few days, as verified by plasma cortisol measurements. Treatment with the inhaled corticosteroid should be continued at the recommended dose to control asthma.
",,,"Store in a cool and dry place, protected from light.
",12
+1341,Fluticasone Propionate (Topical),fluticasone-propionate-topical-1341,https://medex.com.bd/attachments/Q2ClQfT26OVvRlX9DMVnFlzVb5o6VR/fluticasone-propionate-topical-cream-prescribing-information,Fluticasone & combined preparations topical,Pruritic skin conditions,"Fluticasone Propionate is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid responsive eczema/dermatitis.
","Fluticasone & combined preparations topical
","Fluticasone propionate is a glucocorticoid with high topical anti-inflammatorypotency, but a low HPA-axis suppressive activity after dermal administration. It, therefore, has a therapeutic index which is greater than most of the commonly available steroids. Fluticasone propionate has a high degree of selectivity for the glucocorticoid receptor. In vitro studies show that fluticasone propionate has a strong affinity for, and agonist activity at, human glucocorticoid receptors. This receptor is believed to be responsible for the anti-inflammatory properties of glucocorticoids. Fluticasone propionate has weak affinity forthe progesterone receptor, andvirtually no affinity for the mineralocorticoid, estrogen, or androgen receptors. The therapeutic potency of glucocorticoids is related to the half-life of the glucocorticoid-receptor complex. The half-life of the Fluticasone propionate glucocorticoid-receptor complex is approximately 10 hours.
","Cream: Apply a thin layer of Fluticasone propionate cream to the affected skin areas once daily.
Ointment: Apply a thin layer of Fluticasone propionate Ointment to the affected skin areas twice daily.
",,"No information is available.
","Fluticasone propionate is contraindicated in Rosacea, Acne vulgaris, Perioral dermatitis, Primary cutaneous viral infections (e.g., Herpes simplex, chicken pox), Hypersensitivity to any of the ingredients, Perianal and genital pruritus, etc. The use of Fluticasone propionate is not indicated in the treatment of primarily infected skin lesions caused by infection with fungi or bacteria and dermatoses in children under one year of age, including dermatitis and napkin eruptions.
","The fluticasone propionate preparations are usually well tolerated; local burning and pruritus have been reported. If signs of hypersensitivity appear, application should be stopped immediately. Prolonged and intensive treatment with potent corticosteroid preparations may cause local atrophic changes in the skin such as thinning, striae, dilatation of the superficial blood vessels, hypertrichosis and hypopigmentation.
Secondary infection, particularly when occlusive dressings are used or when skin folds are involved and allergic contact dermatitis have also been reported with corticosteroid use. Exacerbation of the signs and symptoms of the dermatoses have been reported with corticosteroid use.
Prolonged use of large amounts of corticosteroids, or treatment of extensive areas, can result in sufficient systemic absorption to produce the features of hypercorticism. This effect is more likely to occur in infants and children, and if occlusive dressings are used. In infants, the napkin may act as an occlusive dressing.
","Administration of fluticasone propionate during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. The excretion of fluticasone propionate into human breast milk has not been investigated. Plasma levels in patients following dermal application of fluticasone propionate at recommended doses are likely to be low. When fluticasone propionate is used in breastfeeding mothers, the therapeutic benefits must be weighed against the potential hazards to the mother and baby.
","Fluticasone propionate has a very low propensity for systemic absorption, nevertheless, prolonged application of high doses to large areas of the body surface, especially in infants and small children might lead to adrenal suppression. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. The face, more than other areas of the body, may exhibit atropic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating severe eczema. Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and systemic administration of antimicrobial agents. Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressing, and so the skin should be cleansed before a fresh dressing is applied.
",,"Acute overdosage is very unlikely to occur, however, in case of chronic overdosage or misuse the features of hypercorticism may appear, and in this situation, as with any corticosteroid, the application should be discontinued. Overdosage by ingestion of fluticasone propionate cream or ointment is extremely unlikely to occur due to the very low oral bioavailability of fluticasone propionate.
",,,"Store below 30°C.Do not freeze.
",11
+1342,Fluticasone Propionate (Nebuliser Suspension),fluticasone-propionate-nebuliser-suspension-1342,https://medex.com.bd/attachments/UaUZpQbD9xREde5wdbsKStRm5LZwLj/fluticasone-propionate-nebuliser-suspension-prescribing-information,Fluocinolone & Combined Preparations,Asthma,"Adults and adolescents over 16 years of age: Prophylactic management in severe asthma (patients requiring high dose inhaled or oral corticosteroid therapy).
Children and adolescents from 4 to 16 years of age: Treatment of mild to moderate acute exacerbations of asthma.
","Fluocinolone & Combined Preparations, Respiratory corticosteroids
","Fluticasone propionate is a synthetic, trifluorinated glucocorticoid with potent anti-inflammatory activity. In vitro assays using human lung cytosol preparations have established fluticasone propionate as a human glucocorticoid receptor agonist with an affinity 18 times greater than dexamethasone, almost twice that of beclomethasone-17-monopropionate (BMP), the active metabolite of beclomethasone dipropionate, and over 3 times that of budesonide. Data from the McKenzie vasoconstrictor assay in man are consistent with these results.
The precise mechanisms of glucocorticoid action in asthma are unknown. Inflammation is recognized as an important component in the pathogenesis of asthma. Glucocorticoids have been shown to inhibit multiple cell types (e.g., mast cells, eosinophils, basophils, lymphocytes, macrophages, and neutrophils) and mediator production or secretion (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in the asthmatic response. These anti-inflammatory actions of glucocorticoids may contribute to their efficacy in asthma.
Though highly effective for the treatment of asthma, glucocorticoids do not affect asthma symptoms immediately. However, improvement following inhaled administration of fluticasone propionate can occur within 24 hours of beginning treatment, although maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment. When glucocorticoids are discontinued, asthma stability may persist for several days or longer.
","Adults and adolescents over 16 years (prophylactic management in severe asthma): 0.5-2 mg twice daily. The recommended initial dose is 2 mg twice daily. The dosage should then be adjusted until control is achieved or reduced to the minimum effective dose according to the individual response.
Children and adolescents 4 to 16 years of age (treatment of acute exacerbations of asthma): 1 mg twice daily.
",,"Clinically significant drug interactions mediated by Fluticasone Propionate are unlikely.
","Fluticasone Propionate Nebuliser Suspension is contraindicated in patients with a history of hypersensitivity to any component of the preparation.
","Candidiasis of the mouth and throat and/or hoarseness is commonly reported. Patients may find it helpful to rinse out their mouth with water after inhalation. As with other inhalation therapy, paradoxical bronchospasm may occur rarely, with an immediate increase in wheezing after dosing. There have also been rare reports of hypersensitivity reactions manifesting as angioedema, bronchospasm and very rarely, anaphylactic reactions. Other adverse events that may occur rarely include depression of plasma cortisol in adult patients on higher doses, bone density reduction, growth retardation, cataract, glaucoma.
","Pregnancy category B3. There is inadequate evidence of safety of Fluticasone Propionate in human pregnancy. However, as with other drugs the administration of Fluticasone Propionate during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
Use in Lactation: The excretion of Fluticasone Propionate into human breast milk has not been investigated.
","Fluticasone Propionate Nebuliser Suspension should not be used for the treatment of severe acute exacerbations of asthma in children and adolescents as efficacy in this situation has not been established. Patients receiving treatment with nebulised Fluticasone Propionate must be warned that if their clinical condition deteriorates, or if a dose fails to give the usual relief, they should not increase the dose or the frequency of administration, but should seek medical advice. Prolonged therapy with inhaled Fluticasone Propionate Nebuliser Suspension should be reduced gradually and not stopped abruptly, and this should be done under medical supervision.
",,"Acute inhalation of Fluticasone Propionate doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not need emergency action as adrenal function is recovered in a few days, and can be verified by plasma cortisol measurements. However, if higher than recommended dosage is continued over prolonged periods, some degree of adrenal suppression may result. Monitoring of adrenal reserve may be necessary. In cases of Fluticasone Propionate overdose, therapy may still be continued at a suitable dosage for symptom control.
",,,"Store below 30°C. Protect from frost and light. Do not freeze. Store upright. Once ampoules have been removed from their pack, they should be protected from light and used within 28 days. Opened ampoules should be refrigerated and used within 12 hours of opening.
",11
+522,Glibenclamide,glibenclamide-522,https://medex.com.bd/attachments/NfWRRJZyhP92s9P9mMXPAWwGAN8Xnj/glibenclamide-prescribing-information,Sulfonylureas,Type 2 DM,"Glibenclamide is used in the treatment of non insulin dependent diabetes melitus (NIDDM). It is ineffective in completely pancreatectomized patients and in juvenile-onset type of diabetes, in which the pancreas has lost all or nearly all of its capacity to secrete insulin. Such patients require insulin and attempts to control them with oral therapy are dangerous and doomed to failure.
","Sulfonylureas
","Glibenclamide is an orally effective hypoglycaemic agent that reduces blood sugar concentration by stimulating secretion of endogenous insulin from the pancreatic β-cells. It stimulates the mobilization of endogenous insulin with a lower dosage and with few incidence of side effects that any available anti-diabetic. Hypoglycaemic action associated with short-term therapy appears to include reduction of basal hepatic glucose production and enhancement of peripheral insulin action at target sites.
","Initially stabilization dosage: Glibenclamide half tablet (2.5 mg) should be taken initially during or immediately after breakfast. 3-5 days after initiation of the drug, the blood sugar level and urine sugar level should be checked. Daily dose of ½ tablet (2.5 mg) may be continued as maintenance therapy if good control has been achieved. If the result is not good, increment of daily dose in steps of ½ tablet (2.5 mg) is necessary at intervals of 3-5 days up to a maximum of 3 tablets. Daily doses in excess of 10 mg may be taken in 2 divided doses. Patients should be given ½ to 1 tablet of Glibenclamide in changing over from other oral anti-diabetics with a similar action.
Change over from insulin to Glibenclamide: The mildly diabetic patient whose insulin requirement is fewer than 20 units daily, can be started on the initial dosage of Glibenclamide with immediate discontinuation of insulin. If the insulin requirement is moderate or high, the changeover should be made gradually by giving insulin and Glibenclamide simultaneously and slowly cutting down the dose of insulin.
When insulin requirements are increased as in fever, surgical interventions or trauma, the Glibenclamide alone is inadequate and the patient must be given insulin to carry him or her through such critical situation.
This changeover from insulin to Glibenclamide is strictly for NIDDM of fairly recent onset which is being controlled on small doses of insulin. This should preferably be done in hospital or with daily medical supervision.
",,"Alcohol, cyclophosphamide, dicoumarol, monoamino oxidase inhibitors, phenylbutazone, propranolol and other beta-adrenergic blocking agents and certain long-acting sulphonamides may enhance the hypoglycemic effect of Glibenclamide
","Severe metabolic de-compensation with acidosis, pre-comatose states and diabetic coma, severe renal or hepatic dysfunction or serious impairment of typhoid or adrenal function; pregnancy, diabetes mellitus complicated by fever, trauma or gangrene.
","Glibenclamide is well tolerated. Few side effects that may arise include nausea, vomiting, epigastric pain, dizziness, weakness, paraesthesia and headache. Allergic skin reactions and haemopoietic reactions (leukopenia, thrombocytopenia, etc.) are occasionally observed.
","There is no information on the use of Glibenclamide in human pregnancy but it has been in wide, general use for many years without apparent ill consequence. Animal studies have shown no hazard. It has not yet been established whether Glibenclamide is transferred to human milk. However, other sulphonylureas have been found in milk and there is no evidence to suggest that Glibenclamide differs from the group in this respect.
","Weight reduction is of the greatest importance in the treatment of diabetes. A vigorous effort must be made by the patient and the physician to reduce the patient's weight as an integral part of diabetic treatment, irrespective of the drug chosen.
",,"Symptoms: Hypoglycaemia.
Management: Mild hypoglycaemic symptoms without loss of consciousness or neurologic findings may be treated with oral glucose and adjust drug dosage and/or meal patterns.
",,,"Should be stored in a dry place below 30˚ C.
",11
+1587,Glecaprevir + Pibrentasvir,glecaprevir-pibrentasvir-1587,https://medex.com.bd/attachments/qakA1EuERlgZf1TbqTVf8bHx16UEqA/glecaprevir-pibrentasvir-prescribing-information,Hepatic viral infections (Hepatitis C),Chronic hepatitis C,"This is a fixed-dose combination of glecaprevir, a hepatitis C virus (HCV) NS3/4A protease inhibitor, and pibrentasvir, an HCV NS5A inhibitor, and is indicated for the treatment of patients with chronic HCV genotype (GT) 1, 2, 3, 4, 5 or 6 infection without cirrhosis and with compensated cirrhosis (Child-Pugh ... Read more
This is a fixed-dose combination of glecaprevir, a hepatitis C virus (HCV) NS3/4A protease inhibitor, and pibrentasvir, an HCV NS5A inhibitor, and is indicated for the treatment of patients with chronic HCV genotype (GT) 1, 2, 3, 4, 5 or 6 infection without cirrhosis and with compensated cirrhosis (Child-Pugh A). This is also indicated for the treatment of adult patients with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both.
","Hepatic viral infections (Hepatitis C)
","Glecaprevir is an inhibitor of the HCV NS3/4A protease, which is a viral enzyme necessary for the proteolytic cleavage of the HCV encoded polyprotein into mature forms of the NS3, NS4A, NS4B, NS5A, and NS5B proteins. These multifunctional proteins, including NS3, are essential for viral replication. The N-terminal of NS3 protein confers serine protease activity, whileThe C-terminus of NS3 encodes a DExH/D-box RNA helicase which hydyolyzes NTP as an energy source to unwind double-stranded RNA in a 3′ to 5′ direction during replication of viral genomic RNA. NS4A is a cofactor for NS3 that directs the localization of NS3 and modulates its enzymatic activities. Glecaprevir disrupts the intracellular processes of the viral life cycle through inhibiting the NS3/4A protease activity of cleaving downstream junctions of HCV polypeptide and proteolytic processing of mature structural protein.
NS5A is a phosphoprotein that plays an essential role in replication, assembly and maturation of infectious viral proteins. The basal phosphorylated form of NS5A, which is maintained by C-terminal serine cluster, is key in ensuring its interaction with the viral capsid protein, or the core protein. By blocking this interaction, pibrentasvir inhibits the assembly of proteins and production of mature HCV particles. NS5A also interacts with viral and cellular proteins to form the HCV replicase complex, and supports the RNA replication of HCV
","Testing Prior to the Initiation of Therapy: Test all patients for HBV infection by measuring HBsAg and anti-HBc.
Recommended dosage: Three tablets (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg) taken orally once daily with food.
See recommended treatment duration in tables below-
Treatment-Naïve Patients: HCV Genotype 1, 2, 3, 4, 5, or 6
+
+- No Cirrhosis: 8 weeks
+- Compensated Cirrhosis (Child-Pugh A): 12 weeks
+
+Treatment-Experienced Patients: HCV Genotype 1
+
+- Patients Previously Treated With a Regimen Containing: An NS5A inhibitor without prior treatment with an NS3/4A protease inhibitor
+- No Cirrhosis: 16 weeks
+- Compensated Cirrhosis (Child-Pugh A): 16 weeks
+
+Treatment-Experienced Patients: HCV Genotype 1
+
+- Patients Previously Treated With a Regimen Containing: An NS3/4A PI without prior treatment with an NS5A inhibitor
+- No Cirrhosis: 12 weeks
+- Compensated Cirrhosis (Child-Pugh A): 12 weeks
+
+Treatment-Experienced Patients: HCV Genotype 1, 2, 4, 5 or 6
+
+- Patients Previously Treated With a Regimen Containing: PRS
+- No Cirrhosis: 8 weeks
+- Compensated Cirrhosis (Child-Pugh A): 12 weeks
+
+Treatment-Experienced Patients: HCV Genotype 3
+
+- Patients Previously Treated With a Regimen Containing: PRS
+- No Cirrhosis: 16 weeks
+- Compensated Cirrhosis (Child-Pugh A): 16 weeks
+
",,"Carbamazepine, efavirenz, and St. John’s wort may decrease concentrations of glecaprevir and pibrentasvir. Coadministration of carbamazepine, efavirenz containing regimens, and St. John’s wort with this preparation is not recommended.
","Patients with severe hepatic impairment (Child-Pugh C). Coadministration with atazanavir and rifampin
","In subjects receiving this preparation, the most commonly reported adverse reactions (greater than 10%) are headache and fatigue.
","No adequate human data are available to establish whether or not this preparation poses a risk to pregnancy outcomes. It is not known whether the components of this preparation are excreted in human breast milk, affect human milk production, or have effects on the breastfed infant. When administered to lactating rodents, the components of this preparation were present in milk, without effect on growth and development observed in the nursing pups. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for this preparation and any potential adverse effects on the breastfed child from this preparation or from the underlying maternal condition.
","Risk of Hepatitis B Virus Reactivation: Test all patients for evidence of current or prior HBV infection before initiation of HCV treatment. Monitor HCV/HBV coinfected patients for HBV reactivation and hepatitis flare during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
","Renal Impairment: No dosage adjustment is required in patients with mild, moderate or severe renal impairment, including those on dialysis
Hepatic Impairment: No dosage adjustment is required in patients with mild hepatic impairment (Child-Pugh A). This is not recommended in patients with moderate hepatic impairment (Child-Pugh B). Safety and efficacy have not been established in HCV-infected patients with moderate hepatic impairment. This is contraindicated in patients with sev.
","In case of overdose, the patient should be monitored for any signs and symptoms of toxicities. Appropriate symptomatic treatment should be instituted immediately. Glecaprevir and pibrentasvir are not significantly removed by hemodialysis.
",,,"Store at or below 30°C
",12
+521,Gentian Violet,gentian-violet-521,,Crystal violet/ Gentian violet preparations,Topical antiseptic,"Topical antiseptic as first aid to help prevent infection in minor cuts, scrapes and burns
","Crystal violet/ Gentian violet preparations
","In aqueous solutions Gentian violet (GV) dissociates into positive (GV+)and negative ions (Cl-) that penetrate through the wall and membrane of both gram-positive and gram-negative bacterial cells. The GV+ interacts with negatively charged components of bacterial cells including the lipopolysaccharide (on the cell wall), the peptidoglycan and DNA. A similar cell penetration and DNA binding process is thought to take place for fungal cells as well. Because Gentian violet is a mutagen and mitotic poison, cell growth is consequently inhibited. A photodynamic action of gentian violet, apparently mediated by a free-radical mechanism, has recently been described in bacteria and in the protozoan T. cruzi. Evidence also suggests that gentian violet dissipates the bacterial (and mitochondrial) membrane potential by inducing permeability. This is followed by respiratory inhibition. This anti-mitochondrial activity might explain gentian violet's efficacy towards both bacteria and yeast with relatively mild effects on mammalian cells.
","Clean the affected area and apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage.
",,"There are no known drug interactions and none well documented.
","Do not apply to an ulcerative lesion as this may cause tattoing of the skin.
","Redness, irritation, swelling or pain persists or increases of if infection occurs.
","Pregnancy Category- Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
","Stop use if the condition persists or gets worse. Do not use longer than 1 week.
",,,,,,9
+1385,Gentamicin Sulfate (Topical),gentamicin-sulfate-topical-1385,https://medex.com.bd/attachments/xuVUK7Muv6MzzksrEnFb3VDM3tCswz/gentamicin-sulfate-topical-prescribing-information,Topical Antibiotic preparations,Bacterial skin infections,"Indicated for Burn, Eczema, Seborrhetic dermatitis, Ecthyma, Excoriation, Folliculitis, Furunculosis, Insect bites and stings, Lacerations and abrasions, Paronychia, Pyoderma gangrenosum, Skin cysts and abscesses, Stasis ulcers and infected skin ulcers, Bacterial, fungal or viral superinfection, Sycosis barbae, minor surgical wounds, infected contact dermatitis caused by susceptible organisms.
","Topical Antibiotic preparations
","Gentamicin Sulphate is an aminoglycoside antibiotic. It is a proven bactericidal antibiotic active against Gram-positive & Gram-negative pathogens including E. coli, Klebsiella, Proteus, Pseudomonas aeruginosa and penicillin resistant strains of Staph. aureus. In common with other aminoglycoside antibiotics, it appears to interfere with protein synthesis of the bacterial cell.
","Apply 3 times daily. Before application, the area should be washed with soap and water and dried thoroughly. If crusts present, it should be removed before the application of ointment to provide maximum contact with the infecting organisms.
",,,"Gentamicin injection and Gentamicin ointment are contraindicated to patients hypersensitive to Gentamicin. It is contraindicated in pregnancy and myasthenia gravis.
","Itching, redness, swelling or other signs of irritation.
","Pregnancy Category D. Small amounts of Gentamicin have been detected in breast milk. So, it is recommended that breastfeeding should be discontinued during treatment.
","Gentamicin Ointment should not be applied to patients hypersensitive to Gentamicin.
",,,,,"Store below 30°C and protected from light.
",9
+1384,Gentamicin Sulfate (Ophthalmic),gentamicin-sulfate-ophthalmic-1384,https://medex.com.bd/attachments/XhefASezu12uAWXYEpPq53WaF5vMeN/gentamicin-sulfate-ophthalmic-prescribing-information,Ophthalmic antibacterial drugs,tympanoplasty,"Blepharitis, blepharoconjunctivitis, conjunctivitis, dacryocystitis, keratitis, keratoconjunctivitis, acute meibomianitis, and corneal ulcers caused by susceptible organisms. Otorrhea associated with external otitis, chronic suppurative otitis media or subacute purulent otitis media; or postoperative otorrhea, such as that following fenestration, mastoidectomy or tympanoplasty.
","Ophthalmic antibacterial drugs
","Gentamicin sulphate actively transported across the bacterial cell membrane, binds to a specific receptor protein on the 30S subunit of bacterial ribosomes and interferes with an initiation complex between mRNA (messenger RNA) and the 30 S subunit, inhibiting protein synthesis. DNA may be misread, thus producing nonfunctional proteins; polyribosomes are split apart and are unable to synthesize protein.
Eye drops may be absorbed following topical application to the eye. Ear drops may be absorbed following topical application to the ear, especially if the eardrum is perforated or if tissue damage is present.
Gentamicin sulphate is active against many strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Niesseria gonorrhoea, Pseudomonus aeruginosa, and Serratia marcescens.
","Eye: 1-2 drops instilled in affected eye up to 6 times a day or more frequently if required (severe infections may require 1-2 drops every 15-20 minutes initially, reducing the frequency of instillation gradually as the infection is controlled).
Ear: The area should be cleaned and 2-3 drops should be instilled every 3-4 times a day and at night, or more frequently if required.
",,"None has been reported so far with topical and Eye/Ear drops.
","This drug is contraindicated in individuals with a history of sensitivity reaction to any of its components. Use of topical Gentamicin may occasionally allow overgrowth of nonsusceptible organisms, including fungi.
","In patients with dermatoses treated with gentamicin, irritation (erythema and pruritus) had been reported in small number of cases. Itching, redness, swelling or other signs of irritation may develop. With the eye/ear drop bacterial and corneal ulcer have developed during treatment with gentamicin. Most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non specific conjunctivitis, conjunctival epithelial defects, and conjunctival hyperemia.
","Consideration should be given the possibility of foetal ototoxicity when gentamicin is applied topically to large denuded areas of skin. For Gentamicin Eye/Ear Drops safety profile in pregnancy is not yet established and should be administered when considered essential.
","If these occurs or if irritation, sensitization develops, treatment with gentamicin should be discontinued and appropriate therapy instituted. Gentamicin ear/eye drops is not for injection. It should never be injected subconjunctivally, nor it should be directly introduced into the anterior chamber of the eye.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children. To avoid contamination, do not touch the tip of the container to the eye, eyelid or any surface.
",10
+1505,Gentamicin Sulfate (Injection),gentamicin-sulfate-injection-1505,,Aminoglycosides,Urinary tract infection,"Gentamicin Injection is indicated in the treatment of serious infections caused by susceptible strains of the microorganisms including: Pseudomonas aeruginosa, Proteus sp, Escherichia coli, Klebsiella, Enterobacter, Serratia and Staphylococcus spp.
Gentamicin Injection is used for ... Read more
Gentamicin Injection is indicated in the treatment of serious infections caused by susceptible strains of the microorganisms including: Pseudomonas aeruginosa, Proteus sp, Escherichia coli, Klebsiella, Enterobacter, Serratia and Staphylococcus spp.
Gentamicin Injection is used for the treatment of the following conditions when caused by susceptible organisms: Septicaemia, Meningitis, Respiratory tract infections, Infected wounds, Skin and skin structure infection, bone and soft tissue infections including peritonitis, septic abortion and burns complicated by sepsis, urinary tract infections.
","Aminoglycosides
","Gentamicin Sulfate is an aminoglycoside antibiotic. This is a proven bactericidal antibiotic active against a broad spectrum of Gram-negative pathogens including E. coli, Klebsiella, Proteus spp, Enterobacter, Pseudomonas aeruginosa and Serratia species. It is also active against some Gram-positive organisms (e.g. penicillin & methicillin resistant strains of Staphylococcus aureus). In vitro, Gentamicin is also active against Salmonella and Shigella. Gentamicin interferes with bacterial protein synthesis by binding primarily to the 30S sub-units of bacterial ribosomes in susceptible organisms. Cell death results. Other mechanisms of action may contribute to the bactericidal effect of Gentamicin.
","Gentamicin is given by the intramuscular route normally. But intravenous administration may be used if required. The dosage is the same for either route of administration.
Adult: In case of adults, the usual dose is 3-5 mg/kg/day in three divided doses 8 hourly for 7 to 10 days. In patients with impaired renal function, the interval between doses should be increased to 12 hours when the creatinine clearance is 30-70 ml/min, 24 hours for 10-30 ml/min, 48 hours for 5-10 ml/min or may be given as directed by the physician.
Pediatric: Up to 2 weeks: 3 mg/kg/every 12 hours 2 weeks to 12 years: 2 mg/kg/every 8 hours or as directed by the physician.
Intravenous administration: For I.V. administration, the prescribed dose of Gentamicin should be diluted with 100-200 ml sterile normal saline or 5% glucose in water. The concentration of Gentamicin in the solution should not exceed 1 mg/ml. Infusion periods of 30 minutes to 2 hours have been advocated. Gentamicin Injection should be discarded following a single use.
",,"Concurrent use with other potentially nephrotoxic or ototoxic drug substances should be avoided. Potent diuretics such as ethacrynic acid or frusemide may potentiate ototoxic effects of gentamicin. As gentamicin is inactivated by solutions containing beta-lactam antibiotics (penicillins & cephalosporins), the two drugs should not be administered simultaneously.
",,"Vestibular damage, reversible nephrotoxicity, auditory ototoxicity may occur. Symptoms are dizziness, vertigo, tinnitus, roaring in the ears, rarely hearing loss. Adverse renal effects may be also caused, more frequently in patients with a history of renal impairment treated with larger doses than recommended.
","Safety for use in pregnancy and lactation has not been established. Gentamicin crosses the placenta and there is a risk of ototoxicity in the fetus. Gentamicin should only be used where the seriousness of the mother's condition justifies the risk. Small amounts of gentamicin have been detected in breast milk. Therefore it is recommended that breastfeeding be discontinued during therapy unless the expected benefits outweigh any potential risk.
",,,,,,"Should be stored in cool and dry place
",8
+520,Gentamicin + Hydrocortisone Acetate,gentamicin-hydrocortisone-acetate-520,https://medex.com.bd/attachments/o8yWv6c9J50qVZm9HoSwit47SNhaDT/gentamicin-hydrocortisone-acetate-prescribing-information,Hydrocortisone & Combined preparations,Susceptible infections,"Gentamicin & Hydrocortisone ear drops is indicated for the treatment of chronic suppurative otitis media, otitis externa and as prophylactic treatment of otitis externa following trauma. Gentamicin & Hydrocortisone ear drops is also indicated for post-operative local use in surgery to infected ... Read more
Gentamicin & Hydrocortisone ear drops is indicated for the treatment of chronic suppurative otitis media, otitis externa and as prophylactic treatment of otitis externa following trauma. Gentamicin & Hydrocortisone ear drops is also indicated for post-operative local use in surgery to infected mastoid cavities.
Gentamicin & Hydrocortisone cream is indicated for redness, itching, and swelling of the skin
","Hydrocortisone & Combined preparations, Ophthalmic steroid - antibiotic combined preparations
","Gentamicin is an aminoglycoside that binds to 30s and 50s ribosomal subunits of susceptible bacteria disrupting protein synthesis, thus rendering the bacterial cell membrane defective.
Hydrocortisone is a corticosteroid used for its anti-inflammatory and immunosuppressive effects. Its anti-inflammatory action is due to the suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. It may also be used as replacement therapy in adrenocortical insufficiency.
","Ear Drops-
+For Middle Ear Infection: Instill 2-4 drops in the affected ear three to four times a day and at night, or more frequently if required. The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled. The tragus should then be pumped 5 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for two minutes. Repeat, if necessary, for the opposite ear. Discard unused portion after therapy is completed. For Ear
Canal Infection: Instill 2-4 drops in the affected ear three to four times a day and at night, or more frequently if required. The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for two minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear. Discard unused portion after therapy is completed.
+
Cream-
+For redness, itching, and swelling of the skin: Apply to the affected area of the skin two or three times per day.","Ear Drops need to shake well immediately before use.
","Gentamicin: Additive effect with other neurotoxic and/or nephrotoxic drugs including cephalosporins, methicillin, amphotericin B, ciclosporin, cisplatin, potent diuretics (e.g. ethacrynic acid, furosemide) and neuromuscular blocking agents (e.g. succinylcholine, tubocurarine). May potentiate the effect of anticoagulants (e.g. warfarin, phenindione). May antagonise the effect of neostigmine and pyridostigmine. Increased risk of hypocalcaemia with bisphosphonates. Increased risk of neuromuscular blockade with botulinum toxin. Indometacin may increase the plasma concentration of gentamicin in neonates.
Hydrocortisone: Thiazides may enhance hyperglycaemia and hypokalaemia caused by corticosteroids. Increased incidence of peptic ulcer or Gl bleeding with concurrent NSAIDs admin. Response to anticoagulants altered. Dose of antidiabetics and antihypertensives needs to be increased. Decreases serum cone of salicylates and antimuscarinic agents. Ethanol may enhance gastric mucosal irritation. Reduced efficacy with concurrent use of carbamazepine, phenytoin, primidone, barbiturates and rifampicin. Mutual inhibition of metabolism between ciclosporin and corticosteroids increase plasma cone of both drugs. Enhanced effect in women taking oestrogens or oral contraceptives.
","History of hypersensitivity to aminoglycoside; pregnancy; hepatic impairment.
","Allergic contact dermatitis, Transient irritation, burning, stinging, Increased redness, lacrimation
","Pregnancy Category- C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","Concurrent use of neuromuscular blocking agents; myasthenia gravis, parkinsonism; conditions predisposing to ototoxicity and nephrotoxicity; lactation. Monitor plasma concentrations of gentamicin in patients receiving high doses or prolonged courses, in infants, elderly, patients with renal impairment, cystic fibrosis or significant obesity. Monitor auditory and renal functions.
",,,,,,10
+1182,Gemifloxacin,gemifloxacin-1182,https://medex.com.bd/attachments/3DHKjd0802mjAG8YJ8vcQBs7liE8fc/gemifloxacin-prescribing-information,4-Quinolone preparations,Pneumonia,"Gemifloxacin is indicated for the treatment of the following bacterial infections in adults caused by sensitive organisms as follows-
+
+- Acute bacterial exacerbation of chronic bronchitis: caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.
... Read more
Gemifloxacin is indicated for the treatment of the following bacterial infections in adults caused by sensitive organisms as follows-
+
+- Acute bacterial exacerbation of chronic bronchitis: caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.
+- Community-acquired pneumonia (of mild to moderate severity): caused by Streptococcus pneumoniae (including multi-drug resistant strains), Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Klebsiella pneumoniae.
+
","4-Quinolone preparations
","Gemifloxacin is a fluoroquinolone antibiotic. It is bactericidal with minimum bactericidal concentrations. Gemifloxacin acts by inhibiting DNA synthesis through inhibition of the bacterial type II topoisomerases, DNA gyrase, and/or topoisomerase IV (TOPO IV) which are both essential for bacterial growth.
Gemifloxacin is rapidly absorbed after oral administration. It is widely distributed throughout the body. Studies in healthy subjects showed that gemifloxacin is distributed rapidly into target tissues and body fluids such as the lung (epithelial lining fluid, alveolar macrophages, bronchial tissue) and nasal secretions.
Following oral administration of gemifloxacin, approximately 36% and 61% of the dose is excreted in the urine and feces, respectively, as unchanged drug and metabolites. AUC values were generally only slightly higher (approx. 10%) in women than in men. No dose adjustment is required based on gender
","Acute bacterial exacerbation of chronic bronchitis: 320 mg once daily for 5 days.
Community-acquired pneumonia (Mild to moderate severity):
+
+- Due to known or suspected S. pneumoniae, H. influenzae, M. pneumoniae, or C. pneumoniae infection: One 320 mg tablet daily for 5 days.
+- Due to known or suspected multi-drug resistant Streptococcus pneumoniae, K.pneumoniae, or M. catarrhalis infection: One 320 mg tablet daily for 7 days.
+
",,"Gemifloxacin absorption is significantly reduced when aluminium or magnesium containing antacids and iron salts are concomitantly administered. Gemifloxacin should be taken at least 2 hours before or 3 hours after these agents. Gemifloxacin should be taken at least 2 hours before sucralfate administration. No clinically significant interactions have been observed when Gemifloxacin was co-administered with omeprazole theophylline, digoxin, warfarin and oral contraceptives.
","Known hypersensitivity to Gemifloxacin and other quinolones, Patients who have previously suffered tendon damage with fluoroquinolones. Gemifloxacin should not be used in children under 18 years of age.
","The general adverse events include abdominal pain, diarrhea, headache, nausea, rash and vomiting. Some side effects have been infrequently reported such as fungal overgrowth in body, dizziness and insomnia, urticaria, pruritis and a maculopapular erythmatous skin rash.
","Gemifloxacin should not be used in pregnant or lactating women. The safety and efficacy of Gemifloxacin in pregnant or lactating women have not been established.
","For patients with severe impairment of renal function, alteration of the dosage regimen to 160 mg once daily is necessary. Adequate hydration of patients receiving Gemifloxacin should be maintained to prevent the formation of a highly concentrated urine and crystalluria. Gemifloxacin may cause dizziness; if this occurs, patients should not operate an automobile or machinery or engage in activities requiring mental alertness or co-ordination.
Tendinitis and tendon ruptures may occur in any age group during treatment with quinolones, including Gemifloxacin, but particularly in elderly patients or when corticosteroids are being co-administered. Gemifloxacin should be discontinued if tendinitis is suspected or at the first sign of pain or inflammation and the affected limb should be rested. In clinical studies with Gemifloxacin a small mean increase in QTc interval was observed. Gemifloxacin should be used with caution in patients predisposed to QTc interval prolongation or in patients taking other medications that are known to prolong the QTc interval. Gemifloxacin should be used with caution in patients with epilepsy.
","Renal impairment: Dose adjustment in patients with mild/moderate renal impairment is not required. Some modification of dosage is recommended for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
+
+- Creatinine Clearance (>40 ml/min): See usual dosage
+- Creatinine Clearance (<40 ml/min): 160 mg once daily
+- Patients on haemodialysis or continuous ambulatory peritoneal dialysis therapy should receive 160 mg once daily.
+
+
Hepatic impairment: Gemifloxacin may be given to patients with hepatic impairment, with no requirement for dose adjustment.
Elderly patients: Dose adjustment is not required.
","No specific antidote is known. Dialysis does not remove Gemifloxacin sufficiently to be useful in overdose. In the event of acute oral overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage; the patient should be carefully observed, treated symptomatically and adequate hydration should be maintained.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+1168,Gemfibrozil,gemfibrozil-1168,https://medex.com.bd/attachments/xXxkEPtTJOP0tw0F0Lt9K9EuE7kmlG/gemfibrozil-prescribing-information,Dyslipidaemic Agents,Obesity,"Gemfibrozil is used as a hypolipidemic agent in conjunction with dietary modification. It is recommended in the treatment of type IIa, type IIb, type III, type IV and type V hyperlipoproteinemia.
","Dyslipidaemic Agents
","Gemfibrozil is an anti-lipemic agent. Gemfibrozil decreases serum triglycerides in healthy individuals and patients with hyper-triglyceridemia. It decreases very low-density lipoprotein (VLDL)- triglyceride concentration and to a lesser extent, LDL triglyceride concentration. HDL-triglyceride is usually decreased slightly. Gemfibrozil usually increases the HDL-cholesterol fraction in healthy individuals and patients with hyperlipoproteinemia, an action that may be beneficial in slowing the progression of atherosclerosis and in reducing the risk of coronary heart disease.
Gemfibrozil also inhibits synthesis of VLDL carrier apolipoprotein B, leading to a decrease in VLDL production. How gemfibrozil raises HDL concentration is not known. Gemfibrozil inhibits lipolysis of fat in adipose tissue and decreases the hepatic uptake of plasma free fatty acids, thereby reducing hepatic triglyceride production.
Gemfibrozil is rapidly and completely absorbed from the gastrointestinal tract. Peak concentration in plasma occurs within 1 to 2 hours; the half-life is about 1.5 hours. About 70% of a dose is excreted in the urine; little is excreted in the faeces.
","The usual dose by mouth is 1.2 gm daily in 2 divided doses given 30 minutes before morning and evening meal. The dosage range may vary between 0.9-1.5 gm daily or as directed by the physician.
",,"Concomitant anticoagulant dosage may need to be reduced and frequent determinations of prothrombin carried out to confirm that the desired prothrombin level has been re-established. There have been reports of severe myositis with marked elevation of creatinine kinase and myoglobinuria when Gemfibrozil and lovastatin were used concomitantly. In most subjects who have had an unsatisfactory lipid response to either drug alone, the possible benefit of combined therapy with lovastatin and Gemfibrozil does not outweigh the risks of severe myopathy, rhabdomyolysis and acute renal failure.
","It is contraindicated in case of alcoholism, hepatic impairment, gallstone, and pregnancy and to patients hypersensitive to Gemfibrozil.
","The most frequent adverse effect involves the G. I. Tract. Abdominal pain and epigastric pain or dyspepsia is common adverse G. I. effects. Other adverse reaction includes pruritus, rash, headache, dizziness, blurred vision, painful extremities and rarely myalgia.
","Safe use in human pregnancy has not been established. It is not known whether gemfibrozil is secreted in human milk. Like most drugs, gemfibrozil should normally be avoided during pregnancy and lactation.
","Risk benefit must be considered in case of lactating mother. Before initiation long-term treatment lipid profile, blood counts, renal activity, annual eye examination and liver function tests should be done.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+518,Gemcitabine,gemcitabine-518,,Cytotoxic Chemotherapy,Uncomplicated pneumococcal pneumonia,"Ovarian Cancer: Gemcitabine in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
Breast Cancer: Gemcitabine in combination ... Read more
Ovarian Cancer: Gemcitabine in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
Breast Cancer: Gemcitabine in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
Non-Small Cell Lung Cancer: Gemcitabine is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer.
Pancreatic Cancer: Gemcitabine is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine is indicated for patients previously treated with 5-FU.
","Cytotoxic Chemotherapy
","Gemcitabine is a synthetic pyrimidine nucleoside and cytarabine analogue which is metabolised intracellularly to active diphosphate and triphosphate nucleosides. It inhibits DNA synthesis by inhibiting DNA polymerase and ribonucleotide reductase. It also induces apoptosis and is primarily active against cells in the S-phase, but may also arrest cells at the G1-S border.
","Intravenous (Adult)-
+
+- Advanced non-small cell lung cancer: 1000 mg/m2 on days 1, 8 and 15 of each 28-day cycle; or 1250 mg/m2 on days 1 and 8 of each 21-day cycle.
+- Pancreatic carcinoma: 1000 mg/m2 once wkly for up to 7 wk followed by 1 wk of rest. Continue thereafter with once wkly infusions for 3 consecutive wk out of 4.
+- Ovarian carcinoma: To be given before carboplatin: 1000 mg/m2 on days 1 and 8 of each 21-day cycle.
+- Breast cancer: Usually in combination with a taxane such as paclitaxel: 1250 mg/m2 on days 1 and 8 of each 21-day cycle.
+- Bladder cancer: To be given before cisplatin. 1000 mg/m2 on days 1, 8 and 15 of each 28-day cycle.
+
",,"May increase the anticoagulant effect of warfarin when used together.
","Concurrent radical radiotherapy; pregnancy, lactation; hypersensitivity
","Bone marrow suppression as manifested by leukopenia, thrombocytopenia, anaemia and myelosuppression. Mild GI effects; rashes; renal impairment, pulmonary toxicity, influenza-like symptoms; interstitial pneumonia, pulmonary oedema. Proteinuria, haematuria and haemolytic uraemic syndrome. Elevation of serum transaminase.
","Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Children, hepatic and renal impairment. May impair ability to drive or operate machinery. Discontinue on 1st sign of microangiopathic haemolytic anaemia. Prolonged infusion time (>60 minutes) and more frequent than wkly dosing may increase toxicity. Monitor CBC before every dose. Increased risk of haemolytic uraemic syndrome and/or thrombocytcpenic purpura which may lead to irreversible renal failure.
",,,,,"Store at 25° C.
",10
+517,Gefitinib,gefitinib-517,https://medex.com.bd/attachments/YoPQ3rqedU4UnMoXFDgY309Sylf86A/gefitinib-prescribing-information,Targeted Cancer Therapy,Non-small cell lung cancer,"Gefitinib is a tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
... Read more
Gefitinib is a tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
Limitation of Use: Safety and efficacy of Gefitinib have not been established in patients whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations.
","Targeted Cancer Therapy
","Gefitinib inhibits the epidermal growth factor receptor (EGFR) tyrosine kinase by binding to the adenosine triphosphate (ATP)-binding site of the enzyme. Thus the function of the EGFR tyrosine kinase in activating the Ras signal transduction cascade is inhibited; and malignant cells are inhibited. Gefitinib is the first selective inhibitor of the EGFR tyrosine kinase which is also referred to as Her1 or ErbB-1. EGFR is overexpressed in the cells of certain types of human carcinomas - for example in lung and breast cancers. Overexpression leads to inappropriate activation of the apoptotic Ras signal transduction cascade, eventually leading to uncontrolled cell proliferation.
","The recommended dose of Gefitinib is 250 mg orally once daily with or without food until disease progression or unacceptable toxicity. Do not take a missed dose within 12 hours of the next dose.
",,"Concomitant use with CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine, barbiturates) may reduce serum gefitinib levels. Plasma concentrations may be increased with potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole). Increased INR or bleeding events with warfarin. May increase plasma levels of metoprolol. May exacerbate vinorelbine-induced neutropenia. Decreased plasma levels and potential reduction in efficacy with drugs that affect gastric pH (e.g. PPIs, H2-receptor antagonists).
","Hypersensitivity. Lactation.
","Common side effects are pruritus, rash, angioedema, urticaria, epistaxis, haematuria, alopecia, dry mouth and skin, nausea, vomiting, anorexia, stomatitis, diarrhoea, nail disorders, asthenia, pyrexia, proteinuria, eye pain, corneal erosion or ulcer, aberrant eyelash growth and elevations in blood creatinine. Rarely, pancreatitis, erythema multiforme, toxic epidermal necrolysis, corneal membrane sloughing, ocular ischemia, or ocular haemorrhage.
","Pregnancy category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Interstitial lung disease (ILD): ILD occurred in patients taking Gefitinib. Gefitinib should be withheld for worsening of respiratory symptoms. It should be discontinued if ILD is confirmed.
Hepatotoxicity: Periodic liver function testing should be performed. Gefitinib should be withheld for Grade 2 or higher for ALT and/or AST elevations. It should be discontinued for severe hepatic impairment.
Gastrointestinal perforation: Gefitinib should be discontinued for gastrointestinal perforation.
Diarrhea: Gefitinib should be withheld for Grade 3 or higher diarrhea.
Ocular Disorders including Keratitis: Gefitinib should be withheld for signs and symptoms of severe or worsening ocular disorders including keratitis. It should be discontinued for persistent ulcerative keratitis.
Bullous and Exfoliative Skin Disorders: Gefitinib should be withheld for Grade 3 or higher skin reactions or exfoliative conditions.
Embryo-fetal Toxicity: Gefitinib can cause fetal harm. Potential risk of Gefitinib to a fetus should be advised and effective contraception should be used.
","Pediatric Use: The safety and effectiveness of Gefitinib in pediatric patients have not been established.
Geriatric Use: No overall differences in safety were observed between patients 65 years and older and those younger than 65 years. There is insufficient information to assess for differences in efficacy between older and younger patients.
Administration to patients who have difficulty swallowing solids: Immerse Gefitinib tablets in 4 to 8 ounces of water by dropping the tablet in water, and stir for approximately 15 minutes. Immediately drink the liquid or administer through a naso-gastric tube. Rinse the container with 4 to 8 ounces of water and immediately drink or administer through the naso-gastric tube.
",,,,"Store between 20-25° C.
",11
+338,Gatifloxacin + Dexamethasone,gatifloxacin-dexamethasone-338,,Ophthalmic steroid - antibiotic combined preparations,Steroid-responsive inflammatory ocular conditions,"This Sterile Eye Drops is indicated for steroid responsive ocular inflammatory conditions with involvement of bacteria like blepharitis, scleritis, episcleritis, iritis, cyclitis, iridocyclitis, choroiditis, optic neuritis and chronic anterior uveitis, disciform and interstitial keratitis, allergic corneal marginal ulcers, corneal injury from chemical radiation or thermal burns.
","Ophthalmic steroid - antibiotic combined preparations
","Dexamethasone is a synthetic glucocorticoid which decreases inflammation by inhibiting the migration of leukocytes and reversal of increased capillary permeability. It suppresses normal immune response.
Gatifloxacin inhibits bacterial DNA gyrase and Topoisomerase IV, the enzymes responsible for replication, transcription and repair of bacterial DNA.
","Instill 1-2 drops into the conjunctival sac 3 to 4 times daily.
",,,"This is contraindicated in epithelial herpes simplex keratitis (Dendritic keratitis), vaccinia, varicella, and in many other viral diseases of the conjunctiva and cornea. It is also contraindicated in mycobacterial infection of the eye, fungal diseases of ocular structures and in individuals hypersensitive to any of the components of the medication.
","Mild burning, chemosis, redness may occur.
","Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Gatifloxacin + Dexamethasone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: Caution should be exercised when Gatifloxacin + Dexamethasone is administered to a nursing mother.
","For ophthalmic use only. If the product is used for 10 days or more, intraocular pressure should be monitored routinely.
","Use in children: Safety and effectiveness in pediatric patients have not been established.
","Overdose through local administration is not known. In case of accidental oral intake, specific measures to reduce resorption should be taken. There is no specific antidote.
",,,"Store at room temperature. Protect from light. Close the bottle immediately after use. Do not use for longer than one month after opening the bottle.
",11
+515,Gatifloxacin (Oral),gatifloxacin-oral-515,https://medex.com.bd/attachments/1q8AgZPhJPiwNwqzW3N7dxcdS3GBFm/gatifloxacin-oral-prescribing-information,4-Quinolone preparations,Urinary tract infection,"Gatifloxacin is indicated in the following infections:
+
+- Acute bacterial exacerbation of chronic bronchitis due to Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Staphylococcus aureus.
+- Acute sinusitis due to Streptococcus pneumoniae or Haemophilus influenzae.
... Read more
Gatifloxacin is indicated in the following infections:
+
+- Acute bacterial exacerbation of chronic bronchitis due to Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Staphylococcus aureus.
+- Acute sinusitis due to Streptococcus pneumoniae or Haemophilus influenzae.
+- Community-acquired pneumonia due to Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Staphylococcus aureus, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Legionella pneumophila.
+- Uncomplicated skin and skin structure infections (i.e., simple abscesses, furuncles, folliculitis, wound infections, and cellulitis) due to Staphylococcus aureus or Streptococcus pyogenes.
+- Uncomplicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.
+- Complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.
+- Pyelonephritis due to Escherichia coli.
+- Uncomplicated urethral and cervical gonorrhea due to Neisseria gonorrhoeae.
+- Acute, uncomplicated rectal infections in women due to Neisseria gonorrhoeae.
+
","4-Quinolone preparations
","Gatifloxacin is a fluoroquinolone antibacterial which acts by inhibiting DNA synthesis in susceptible organisms via inhibition of both DNA gyrase (essential for bacterial reproduction) and topoisomerase IV (essential during bacterial cell division).
","
+- Acute Bacterial Exacerbation of Chronic Bronchitis: 400 mg 5 days
+- Acute Sinusitis: 400 mg 10 days
+- Community-acquired Pneumonia: 400 mg 7-14 days
+- Uncomplicated Skin and Skin Structure Infections: 400 mg 7-10 days
+- Uncomplicated Urinary Tract Infections: 400 mg Single Dose or 200 mg 3 days
+- Complicated Urinary Tract Infections: 400 mg 7-10 days
+- Acute Pyelonephritis: 400 mg 7-10 days
+- Uncomplicated Urethral Gonnorrhea in Men: 400 mg Single dose
+
","Gatifloxacin can be administered without regard to food.
",,"Gatifloxacin is contraindicated in patients with a history of hypersensitivity of Gatifloxacin, quinolone antimicrobial agents, or any other components of this product.
","Gatifloxacin is generally well tolerated. The most common side effects that can occur while taking this drug are usually mild and include nausea, vomiting, stomach pain, diarrhea, dizziness,and headache .
","Pregnancy: Gatifloxacin should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.
Lactation: It is not known whether Gatifloxacin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when gatifloxacin is administered to a nursing woman.
","Gatifloxacin should be administered with caution in the presence of renal insufficiency.
","Renal Impaired patient:
+
+- Creatinine Clearance 40 mL/min: 400 mg every day.
+- Creatinine Clearance < 40 mL/min: 400 mg 200 mg every day.
+
+
Dialysis patients:
+
+- Hemodialysis: 400 mg 200 mg every day.
+- Continuous peritoneal dialysis: 400 mg 200 mg every day.
+
+
Pediatric use: The safety and effectiveness of Gatifloxacinacin in pediatric populations (<18 years of age) have not been established.
","Gatifloxacin exhibits a low potential for acute toxicity in animal studies. In the event of acute oral overdose, the stomach should be emptied by inducing vomiting or by gastric lavage. The patient should be carefully observed (including ECG monitoring) and given symptomatic and supportive treatment. Adequate hydration should be maintained.
",,,,11
+514,Gatifloxacin (Ophthalmic),gatifloxacin-ophthalmic-514,https://medex.com.bd/attachments/WLwCR2VKS4HVSkbMiKfpvjxejXhfgY/gatifloxacin-ophthalmic-03-ophthalmic-solution-prescribing-information,Ophthalmic antibacterial drugs,Inflammation of the cornea,"Gatifloxacin eye drops is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
+
+- Aerobic Gram-Positive Bacteria: Corynebacterium propinquum, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis, Streptococcus pneumoniae
+- Aerobic Gram-Negative Bacteria: Haemophilus influenzae.
+
","Ophthalmic antibacterial drugs
","The antibacterial action of gatifloxacin results from inhibition of DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division. The mechanism of action of fluoroquinolones including gatifloxacin is different from that of aminoglycoside, macrolide, and tetracycline antibiotics. Therefore, gatifloxacin may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to gatifloxacin. There is no crossresistance between gatifloxacin and the aforementioned classes of antibiotics. Cross resistance has been observed between systemic gatifloxacin and some other fluoroquinolones. Resistance to gatifloxacin in vitro develops via multiple-step mutations.
","0.3% eye drops-
+The recommended dosage regimen for the treatment of bacterial conjunctivitis is:
+
+- Days 1 and 2: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times daily.
+- Days 3 through 7: Instill one drop up to 4 times daily while awake.
+
+
0.5% eye drops-
+
Patients 1 year of age or older: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times on Day 1. Instill one drop two to four times daily in the affected eye(s) while awake on Days 2 through 7.
",,"Specific drug interaction studies have not been conducted with gatifloxacin eye drops. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving systemic cyclosporine concomitantly.
","Gatifloxacin eye drops is contraindicated in patients with a history of hypersensitivity to Gatifloxacin, to other quinolones, or to any of the components in this medication. Gatiflox 0.3% eye drops should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.
","The most frequently reported adverse events in the overall study population were conjunctival irritation, increased lacrimation etc.
","Pregnancy Category C. Because there are no adequate and well-controlled studies in pregnant women, Gatifloxacin 0.3% eye drops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Gatifloxacin is administered to a nursing woman.
","Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis. Avoid contaminating the applicator tip with material from the eye, fingers or other source.
","Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
","An overdose of this medication is unlikely to threaten life.
",,,"Store in a cool and dry place, away from light. Keep out of reach of children.
",12
+513,Ganciclovir (Ophthalmic),ganciclovir-ophthalmic-513,https://medex.com.bd/attachments/Sp3JBwhutGbJDi42Lku1EwpaYlWH4J/ganciclovir-ophthalmic-ophthalmic-gel-prescribing-information,Ophthalmic Anti-viral Products,Herpes simplex keratitis,"It is a topical eye antiviral that is indicated for the treatment of acute herpetic keratitis (dendritic ulcers)
","Ophthalmic Anti-viral Products
","This eye gel contains the active ingredient, Ganciclovir, which is a guanosine derivative that, upon phosphorylation, inhibits DNA replication by herpes simplex viruses (HSV). Ganciclovir is transformed by viral and cellular thymidine kinases (TK) to ganciclovir triphosphate, which acts as an antiviral agent by inhibiting the synthesis of viral DNA in two ways: competitive inhibition of viral DNA-polymerase and direct incorporation into viral primer strand DNA, resulting in DNA chain termination and prevention of DNA replication.
","The recommended dosing regimen for Ganciclovir eye gel 0.15% is 1 drop in the affected eye 5 times per day (approximately every 3 hours while awake) until the corneal ulcer heals and then 1 drop 3 times per day for 7 days.
",,,"It is contraindicated to the patients with known hypersensitivity to Ganciclovir.
","Most common adverse reactions reported in patients were blurred vision (60%), eye irritation (20%), punctate keratitis (5%), and conjunctival hyperemia (5%).
","Pregnancy Category C. Ganciclovir has been shown to be embryo toxic in rabbits and mice following intravenous administration and teratogenic in rabbits. Fetal resorptions were present in at least 85% of rabbits and mice administered 60 mg/kg/day and 108 mg/kg/day (approximately 10,000x and 17,000x the human ocular dose of 6.25 mcg/kg/day), respectively, assuming complete absorption.
Nursing Mothers: It is not known whether topical eye ganciclovir administration could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when it is administered to nursing mothers.
","It is indicated for topical eye use only. Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with it.
","Pediatric Use: Safety and efficacy in pediatric patients below the age of 2 years have not been established.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
","Overdose through local or accidental oral administration is not likely.
",,,"Store at 15°C to 30°C in a dry place protected from light. It is desirable that the contents should not be used more than one month after first opening of the tube.
",11
+1414,Gadoversetamide,gadoversetamide-1414,https://medex.com.bd/attachments/2gQk9JQdJHKwO5UJ5FAAocknH4SdQf/gadoversetamide-prescribing-information,Contrast medium for diagnostic procedures,"Intravenous use in MRI to visualize lesions with abnormal vascularity in the brain, spine and associated tissues","Gadoversetamide is a gadolinium-based paramagnetic contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use:
+
+- In patients with abnormal blood-brain barrier or abnormal vascularity of the brain, spine and associated tissues
+- To provide contrast enhancement and facilitate visualization of lesions with abnormal vascularity in the liver in patients who are highly suspect for liver structural abnormalities on computed tomograph
+
","Contrast medium for diagnostic procedures
","Gadoversetamide is a paramagnetic agent that develops a magnetic moment when placed in a magnetic field. The relatively large magnetic moment can enhance the relaxation rates of water protons in its vicinity, leading to an increase in signal intensity (brightness) of tissues.
","Bolus peripheral intravenous injection at a dose of 0.2 mL/kg (0.1 mmol/kg). Follow injection with a 5 mL normal saline flush. Complete imaging procedure within 1 hour of injection
",,"Drug interactions with other contrast agents and other drugs have not been studied.
","Chronic, severe kidney disease (glomerular filtration rate, GFR<30 mL/min/1.73m2), acute kidney injury. Prior hypersensitivity reactions to gadolinium, versetamide or any of the inert ingredients
","Most common adverse reactions (incidence >2%) are: headache, vasodilatation, taste perversion, dizziness, nausea and paresthesia.
","use Gadoversetamide only if imaging is essential during pregnancy and cannot be delayed. Radiolabeled gadoversetamide (153Gd) was excreted in the milk of lactating rats receiving a single intravenous dose of 0.1 mmol/kg. Women should discontinue nursing and discard breast milk up to 72 hours after Gadoversetamide administration
","Nephrogenic Systemic Fibrosis (NSF) has occurred in patients with impaired elimination of Gadolinium Based Contrast Agents (GBCAs). Higher than recommended dosing or repeat dosing appears to increase the risk.
Hypersensitivity reactions including fatal reactions have occurred, particularly in patients with history of allergy, drug reactions, or other hypersensitivity-like disorders. Monitor these patients closely during and after administration of gadoversetamide.
Gadolinium is retained for months or years in brain, bone, and other organs.
Acute Kidney Injury (AKI) has occurred in patients with preexisting renal insufficiency. Use the lowest necessary dose of gadoversetamide in these patients.
Interference with laboratory measurements of serum iron, copper and zinc and in the measurement of serum calcium using the ortho-cresophthalin complexone (OCP) colorimetric method has occurred.
","Pediatric Use: The safety and effectiveness of Gadoversetamide in pediatric patients have not been established. Pediatric patients may be particularly vulnerable to adverse GBCA reactions due to renal immaturity or unrecognized renal insufficiency.
Geriatric Use: Since gadoversetamide is cleared from the body by glomerular filtration, the risk of adverse reactions may be greater in patients with impaired renal function (GFR ≥30 and <90 mL/min/1.73m2). Due to the risk for NSF, estimate the GFR through laboratory testing for patients >60 years of age
","Clinical consequences of overdosage with Gadoversetamide have not been reported. Treatment of overdose is directed toward supporting vital functions and prompt institution of symptomatic therapy. Gadoversetamide has been shown to be dialyzable
",,,"Gadoversetamide should be stored at 20°C to 25°C and protected from light and freezing. Gadoversetamide may be stored at 37°C for up to one month in a contrast media warmer utilizing circulating warm air. For periods longer than one month, store at 20°C to 25°C
",12
+511,Gadodiamide,gadodiamide-511,https://medex.com.bd/attachments/Lzp13q4h2K2p9YuA6ZMU8xtQ53gk7O/gadodiamide-prescribing-information,Contrast medium for diagnostic procedures,"Intravenous use in MRI to visualize lesions with abnormal vascularity in the brain, spine and associated tissues","CNS (Central Nervous System): Gadodiamide is a gadolinium-based contrast agent indicated for intravenous use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial ... Read more
CNS (Central Nervous System): Gadodiamide is a gadolinium-based contrast agent indicated for intravenous use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues.
Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic And Retroperitoneal Regions): Gadodiamide is a gadolinium-based contrast agent indicated for intravenous use in MRI to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space.
","Contrast medium for diagnostic procedures
","The paramagnetic properties of Gadodiamide provides contrast enhancement during MRI. There were no clinically significant deviations from pre-injection values in haemodynamic and blood and urine laboratory parameters following intravenous injection of gadodiamide in healthy volunteers. However, a minor transient change in serum iron levels 8 to 48 hours after gadodiamide injection was observed.
Gadodiamide does not cross the intact blood-brain barrier. Administration of Gadodiamide causes signal enhancement from areas where blood-brain barrier dysfunction has been induced by pathological processes, and may provide greater diagnostic yield than unenhanced MRI. Lack of enhancement need not indicate absence of pathology since some types of low grade malignancies or inactive MS-plaques fail to enhance; it can be used for differential diagnosis between different pathologies.
","No special preparation of the patient is required. Gadodiamide should be drawn into the syringe immediately before use.The vial is intended for one patient only. Contrast medium not used in one examination must be discarded.
CNS (Central Nervous System):
+
+- Adults: The recommended dose of Gadodiamide is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection.
+- Pediatric Patients (2-16 years): The recommended dose of Gadodiamide is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection.
+
+Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic And Retroperitoneal Regions):
+
+- Adult and Pediatric Patients (2-16 years of age): For imaging the kidney, the recommended dose of Gadodiamide is 0.1 mL/kg (0.05 mmol/kg). For imaging the intrathoracic (noncardiac), intra-abdominal, and pelvic cavities, the recommended dose of Gadodiamide is 0.2 mL/kg (0.1 mmol/kg)
+
",,"There are no known drug interactions and none well documented.
","Chronic, severe kidney disease (glomerular filtration rate < 30 ml/ min/1.73 m2), or acute kidney injury prior hypersensitivity reaction, should not be used in patients known to have hypersensitivity to Gadodiamide or its constituents.
","Nephrogenic systemic fibrosis, Hypersensitivity reactions
","Pregnancy category B3. No effects of Gadodiamide on reproductive performance were seen in rats at doses up to 1.0 mmol/kg. In rabbits, there is an increased incidence of litters with skeletal or visceral abnormalities at doses up to 0.5 and 1.0 mmol/kg. However, these effects are possibly attributable to maternal toxicity rather than a direct effect of the drug. There are no adequate and well-controlled studies of Gadodiamide in pregnant women. Gadodiamide should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Use in Lactation: It is not known whether Gadodiamide is excreted in human milk. Breast-feeding should be discontinued prior to administration and should not be recommenced until at least 24 hours after the administration of Gadodiamide.
","Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast enhanced MRI or other modalities.
The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73m2) as well as patients with acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function.
","Use in Children: The safety and effectiveness of Gadodiamide have been established for whole body magnetic resonance imaging in children from 6 months of age.The safety and effectiveness in infants and neonates have been established in the evaluation of lesions within the brain and spine.
There is no experience with Gadodiamide in children below 6 months of age with severe hepatic or renal disease, or with premature infants below 4 weeks, or those with a post-conceptional age of less than 30 weeks.
Use in elderly patients: Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.
","Clinical consequences of overdose have not been reported and acute symptoms of toxicity are unlikely in patients with a normal renal function. Treatment is symptomatic. There is no antidote for this contrast medium. In patients with delayed elimination due to renal insufficiency and in patients who have received excessive doses, the contrast medium can be eliminated by haemodialysis.
",,,"Store at temperatures not exceeding 25° C. Protect from light.
",12
+510,Gabapentin,gabapentin-510,https://medex.com.bd/attachments/GGuZTfj9qx9i0w84yuuo8qGTwFwkk9/gabapentin-prescribing-information,Adjunct anti-epileptic drugs,Trigeminal neuralgia,"Gabapentin is indicated for-
+
+- Neuropathic Pain.
+- Adjunctive therapy in partial seizure and secondary generalized seizure.
+
","Adjunct anti-epileptic drugs
","Gabapentin is an anti-convulsant. It is a structural analog of gamma-amino-butyric-acid (GABA). All pharmacological actions following administration of Gabapentin are due to the activity of parent compound. Gabapentin binds with the alpha-2-delta subunit of voltage gated L-type Calcium channel, and inhibits branched chain amino acid transferase & probably inhibits neurotransmitter release of excitatory amino acid.
","Neuropathic Pain: The treatment may be initiated as a single 300 mg dose on Day-1, than 300 mg twice on Day-2 and 300 mg thrice on Day-3. The dose can be subsequently be titrated up as needed for pain relief to a daily dose of 1800 mg (divided TID).
Epilepsy:
+
+- Patients over 12 years of age: the effective dose of Gabapentin is 900 to 1800 mg/day given in three divided doses. The starting dose is 300 mg three times a day.
+- Paediatric patients age 3-12 year: the starting dose should range from 10-15 mg/kg/day in 3 divided doses, and the effective dose reached by upward titration over a period of approximately three days.
+
","Gabapentin can be taken orally with or without food.
","Antacids may reduce the bioavailability of Gabapentin by up to 20 %. Cimetidine may alter its reanal excretion. Gabapentin does not interact with other anti-epileptic drug or with oral contraceptive preparations.
","Gabapentin is contraindicated in patients who have known hypersensitivity to the drug.
","Fatigue, Dizziness, ataxia, weight gain, peripheral edema, dry mouth and somnolence may occur.
","Pregnancy category C. it should be used during pregnancy only if potential benefits justifies the potential risk to the fetus. Gabapentin may be secreted through the breast milk. So it should be used during lactation only if potential benefits justifies the potential risk to the baby.
","Patients should be instructed to take Gabapentin only as prescribed. While using Gabapentin patients should be instructed either not to drive a car or to operate other complex machinery until they have gained sufficient experiences about Gabapentin whether or not it affects their mental and/or motor performance adversely.
","In case of renal impaired patients Gabapentin doses must be reduced.
",,,,"Store below 25°C temperature. Protect from light and moisture. Keep all the medicines out of the reach of the children.
",12
+509,Fusidic acid + Hydrocortisone,fusidic-acid-hydrocortisone-509,https://medex.com.bd/attachments/eN1LLcmMnjfRR3XUsYGhCNhX72TASc/fusidic-acid-hydrocortisone-prescribing-information,Hydrocortisone & Combined preparations,Seborrhoeic dermatitis,"In following skin diseases where bacterial infections are already present or suspected to occur-
+
+- Primary irritant dermatitis
+- Contact allergic dermatitis
+- Eczema (atopic, infantile, discoid, stasis)
+- Seborrhoeic dermatitis
+
","Hydrocortisone & Combined preparations
","Fusidic Acid BP 2% & Hydrocortisone Acetate BP 1% combination cream contains the potent topical antibacterial action of Fusidic Acid with the anti-inflammatory & anti-pruritic effects of Hydrocortisone Acetate. When applied topically, Fusidic Acid is effective against Staphylococci, Streptococci, Corynebacteria, Neisseria and certain Clostridia & Bacteroides. Fusidic Acid is an antimicrobial agent that acts as an inhibitor of protein synthesis in the microorganism. It interferes with translocation step by stabilizing the ribosome-guanosine diphosphate elongation factor G-complex. This prevents binding of aminoacyl t-RNA to the ribosome and thereafter stops transfer of additional amino acids to the growing polypeptide. In humans, Hydrocortisone is the principal naturally occurring glucocorticosteroid. In pharmaceutical dosage, its main action is to reduce the response of the skin to injury (i.e. anti-in ammatory). It also has immuno suppressant & anti-mitotic actions.
","Adults: This Cream should be applied 3 times daily and gently massaged onto the affected areas for 2 weeks. A shorter course should be considered if symptoms improve.
Children: It is not recommended in children under 3 years of age.
",,"If absorbed systemically, Fusidic Acid may inhibit the metabolism of drugs that undergo extensive biotransformation in the liver, but no evidence for this is available. No hazardous drug interactions are reported with topical Hydrocortisone Acetate.
","This preparation is contraindicated in patients with hypersensitivity to Fusidic Acid, Hydrocortisone Acetate, or other components of the cream. As with other topical antibiotic/corticosteroid combination preparations, it is contraindicated in bacterial infections due to non-susceptible organisms, fungal infections, tuberculosis of the skin, syphilitic skin infections, chicken pox, eruptions following vaccinations and viral diseases of the skin in general.
","Fusidic Acid has been reported to cause mild irritation at the application site, but did not usually require discontinuation of therapy. Reports of hypersensitivity reactions have been rare. Adverse effects are generally local and include: dryness, itching, burning, local irritation, striae, skin atrophy, atrophy of subcutaneous tissues, telangiectasia, hypertrichosis, change in pigmentation and secondary infection. If applied to the face, acne rosacea or perioral dermatitis can occur.
","The safety of Fusidic Acid and/or topical Hydrocortisone Acetate during pregnancy or lactation has not been established. The use of this cream during pregnancy or lactation requires that the potential bene ts be weighed against the risks to the fetus or nursing infant.
","Fusidic Acid and Hydrocortisone Acetate should not be used in or near the eye because of the possibility of conjuctival irritation by Fusidic Acid. When used under occlusive dressing, over extensive areas or on the face, scalp, axillae and scrotum, suffcient absorption may occur, giving rise to adrenal suppression and other systemic effects.
","Use in children: Clinical trials with Fusidic Acid & Hydrocortisone Acetate have not demonstrated any increased incidence of adverse effects in children 3 years and over. There are no data from randomized, controlled clinical trials on the safety and efficacy of this combination in children under 3 years of age.
",,,,"Store below 30°C, away from light and moisture. Keep out of the reach of children.
",11
+1972,Fusidic acid + Betamethasone,fusidic-acid-betamethasone-1972,https://medex.com.bd/attachments/S2KBnDc016Kq2dqJoKoM6mE6gWwYgy/fusidic-acid-betamethasone-prescribing-information,Other Topical corticosteroids,Seborrhoeic dermatitis,"This cream is indicated in eczema and dermatitis with secondary infections including atopic dermatitis, allergic and seborrhoeic dermatitis and primary irritant dermatitis.
","Other Topical corticosteroids
","Fusidic acid is only effective against gram-positive bacteria such as Streptococcus, Staphylococcus aureus and Corynebacterium minutissimum. The antibacterial action of fusidic acid results from inhibition of bacterial protein synthesis. The drug interferes with amino acid transfer from aminoacyl-tRNA to protein on the ribosomes. Betamethasone induces lipocortin which inhibits phospholipase A-2 enzyme which results in the inhibition of different inflammartory mediators synthesis like prostaglandins, cinins, histamines.
Pharmacokinetics: Fusidic acid can penetrate intact human skin. As much as 2% of the amount of topically applied fusidic acid penetrates intact skin. The degree of penetration depends on factors such as the duration of exposure to fusidic acid and the condition of the skin. Fusidic acid is excreted mainly in the bile with little excreted in the urine. Dermal absorption and potency of any topical corticosteroid including betamethasone depends on the vehicle in which the steroid is delivered. Absorption of betamethasone may be higher in certain body areas such as the face, groin, axilla, or on injured or inflamed skin such as the lesions of atopic dermatitis.
","Adults: It should be applied 2 times daily and gently massaged into the affected areas for 2 weeks. A shorter course should be considered if symptoms improve.
Children: It is not recommended in children under 3 years of age.
",,"Other topical (skin-applied) medications contain corticosteroids.
","Topical hydrocortisone is contraindicated in viral tuberculosis and fungal skin infections. Hypersensitivity to any of the components.
","Possible side effects are allergic reactions, headache, skin rash, redness or itching, unusual tiredness or weakness, yellow eyes or skin.
","Fusidic acid and betamethasone should not be used in pregnancy. Both of them have been detected in the breast milk, so nursing mothers are advised not to use the drug.
","Long term continuous therapy should be avoided, particularly in the face, on flexures and intertriginous areas and in infants and children.
",,,,,"Keep out of reach of children. Store in a dry place, below 25˚C temperature and protected from light.
",10
+1836,Glycopyrronium Bromide (Oral solution),glycopyrronium-bromide-oral-solution-1836,https://medex.com.bd/attachments/ZNyoka7bwiCWYfMz4uvV6FnKSvA7v2/glycopyrronium-bromide-oral-solution-prescribing-information,Anticholinergics (antimuscarinics)/ Anti-spasmodics,Cerebral palsy,"Glycopyrronium Bromide is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).
","Anticholinergics (antimuscarinics)/ Anti-spasmodics
","Glycopyrrolate is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including salivary glands. Glycopyrrolate indirectly reduces the rate of salivation by preventing the stimulation of these receptors. Glycopyrrolate inhibits the action of acetylcholine on salivary glands thereby reducing the extent of salivation.
","Glycopyrronium Bromide oral solution must be measured and administered with an accurate measuring device. Initiate dosing at 0.02 mg/kg orally three times daily and titrate in increments of 0.02 mg/kg every 5-7 days based on therapeutic response and adverse reactions. The maximum recommended dosage is 0.1 mg/kg three times daily not to exceed 1.5-3 mg per dose based upon weight.
During the four-week titration period, dosing can be increased with the recommended dose titration schedule while ensuring that the anticholinergic adverse events are tolerable. Prior to each increase in dose, review the tolerability of the current dose level with the patient’s caregiver.
Glycopyrronium Bromide oral solution should be dosed at least one hour before or two hours after meals. The presence of high-fat food reduces the oral bioavailability of this oral solution if taken shortly after a meal
",,"Digoxin tablets: Use with glycopyrrolate can increase digoxin serum levels. Monitor patients and consider use of alternative dosage forms of digoxin.
Amantadine: Effects of glycopyrrolate may be increased with concomitant administration of amantadine. Consider decreasing the dose of glycopyrrolate during concomitant use.
Atenolol or metformin: Glycopyrrolate may increase serum levels of atenolol or metformin. Consider dose reduction when used with glycopyrrolate.
Haloperidol or levodopa: Glycopyrrolate may decrease serum levels of haloperidol or levodopa. Consider a dose increase when used with glycopyrrolate.
","Glycopyrronium Bromide oral solution is contraindicated in:
+
+- Patients with medical conditions that preclude anticholinergic therapy (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis).
+- Patients taking solid oral dosage forms of potassium chloride. The passage of potassium chloride tablets through the gastrointestinal (GI) tract may be arrested or delayed with coadministration of Glycopyrronium Bromide oral solution.
+
","
+- Gastrointestinal: Abdominal distention, abdominal pain, stomach discomfort, chapped lips, flatulence, retching, dry tongue
+- General Disorders: Irritability, pain
+- Infections: Pneumonia, sinusitis, tracheostomy infection, upper respiratory tract infection, urinary tract infection
+- Investigations: Heart rate increase
+- Metabolism and Nutrition: Dehydration
+- Nervous System: Headache, convulsion, dysgeusia, nystagmus
+- Psychiatric: Agitation, restlessness, abnormal behavior, aggression, crying, impulse control disorder, moaning, mood altered
+- Respiratory: Increased viscosity of bronchial secretion, nasal congestion, nasal dryness
+- Skin: Dry skin, pruritus, rash
+- Vascular: Pallor
+
","There are no available data in pregnant women for Glycopyrronium Bromide to inform decisions concerning any drug-associated risks. There are no data on the presence of glycopyrrolate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Glycopyrronium Bromide and any potential adverse effects on the breastfed infant from Glycopyrronium Bromide or from the underlying maternal condition.
","Constipation or Intestinal Pseudo-obstruction: Constipation is a common dose-limiting adverse reaction that sometimes leads to glycopyrrolate discontinuation. Assess patients for constipation, particularly within 4-5 days of initial dosing or after a dose increase. Intestinal pseudo-obstruction has been reported and may present as abdominal distention, pain, nausea or vomiting.
Incomplete Mechanical Intestinal Obstruction: Diarrhea may be an early symptom of incomplete mechanical intestinal obstruction, especially in patients with ileostomy or colostomy. If the incomplete mechanical intestinal obstruction is suspected, discontinue treatment with Glycopyrronium Bromide and evaluate for intestinal obstruction.
High Ambient Temperatures: In the presence of high ambient temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs such as Glycopyrronium Bromide. Advise patients/caregivers to avoid exposure of the patient to hot or very warm environmental temperatures.
Operating Machinery or an Automobile: Glycopyrronium Bromide may produce drowsiness or blurred vision. As appropriate for a given age, warn the patient not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery, or performing hazardous work while taking Glycopyrronium Bromide.
Anticholinergic Drug Effects: Use Glycopyrronium Bromide with caution in patients with conditions that are exacerbated by anticholinergic drug effects including:
+
+- Autonomic neuropathy
+- Renal disease
+- Ulcerative colitis- Large doses may suppress intestinal motility to the point of producing a paralytic ileus and for this reason may precipitate or aggravate ""toxic megacolon"", a serious complication of the disease
+- Hyperthyroidism
+- Coronary heart disease, congestive heart failure, cardiac tachyarrhythmias, tachycardia, and hypertension
+- Hiatal hernia associated with reflux esophagitis, since anticholinergic drugs may aggravate this condition
+
","Pediatric Use: Glycopyrronium Bromide was evaluated for chronic severe drooling in patients aged 3-16 years with neurologic conditions associated with problem drooling. Glycopyrronium Bromide has not been studied in subjects under the age of 3 years.
Geriatric Use: Clinical studies of Glycopyrronium Bromide did not include subjects aged 65 and over.
Renal Impairment: Because glycopyrrolate is largely renally eliminated, Glycopyrronium Bromide should be used with caution in patients with renal impairment
","Because glycopyrrolate is a quaternary amine which does not easily cross the blood-brain barrier, symptoms of glycopyrrolate overdosage are generally more peripheral in nature rather than central compared to other anticholinergic agents. In case of accidental overdose, therapy may include:
+
+- Maintain an open airway, providing ventilation as necessary.
+- Managing any acute conditions such as hyperthermia, coma and or seizures as applicable, and managing any jerky myoclonic movements or choreoathetosis which may lead to rhabdomyolysis in some cases of anticholinergic overdosage.
+- Administering a quaternary ammonium anticholinesterase such as neostigmine to help alleviate-peripheral anticholinergic effects such as anticholinergic induced ileus.
+- Administering activated charcoal orally as appropriate.
+
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+553,Glycopyrronium Bromide (Injection),glycopyrronium-bromide-injection-553,https://medex.com.bd/attachments/ydYRaa7C7THtIUYQN8PBdhxOLwEyQ4/glycopyrronium-bromide-injection-injection-prescribing-information,Anticholinergics (antimuscarinics)/ Anti-spasmodics,Reverse residual neuromuscular blockade,"In Anesthesia:
+
+- As a pre-operative antimuscarinic agent to reduce salivary, tracheobronchial and pharyngeal sections and to reduce the acidity of the gastric contents.
+- As a pre-operative or intra-operative antimuscarinic to attenuate or prevent intra-operative bradycardia with the use of suxamethonium or due to cardiac vagal reflexes.
... Read more
In Anesthesia:
+
+- As a pre-operative antimuscarinic agent to reduce salivary, tracheobronchial and pharyngeal sections and to reduce the acidity of the gastric contents.
+- As a pre-operative or intra-operative antimuscarinic to attenuate or prevent intra-operative bradycardia with the use of suxamethonium or due to cardiac vagal reflexes.
+- To protect against the peripheral muscarinic actions of anticholinesterases such as neostigmine and pyridostigmine, used to reverse residual neuromuscular blockade produced by non-depolarizing muscle relaxants.
+
+
In Peptic Ulcer: For use in adults as adjunctive therapy for the treatment of a peptic ulcer when the rapid anticholinergic effect is desired or when oral medication is not tolerated.
","Anticholinergics (antimuscarinics)/ Anti-spasmodics
","Glycopyrronium bromide is a quaternary ammonium antimuscarinic with peripheral effects. It is used in anesthetic practice. Given as a premedication before general anesthesia, it diminishes the risk of vagal inhibition of the heart and reduces salivary and bronchial secretions. Intra-operatively, it may be given to reduce bradycardia and hypotension induced by drugs such as suxamethonium, halothane or propofol. Glycopyrronium bromide may be used before or with anticholinesterases such as neostigmine to prevent their muscarinic adverse effects. Antimuscarinic drugs are competitive inhibitors of the actions of acetylcholine at the muscarinic receptors of autonomic effector sites innervated by parasympathetic(cholinergic postganglionic) nerves, as well as being inhibitors of the action of acetylcholine on smooth muscle lacking cholinergic innervation. Peripheral antimuscarinic effects that are produced as the dose increases are: decreased production of secretions from the salivary, bronchial and sweat glands; dilatation of the pupils (mydriasis) and paralysis of accommodation (cyclopegia); increased heart rate; inhibition of micturition and reduction in gastrointestinal tone; inhibition of gastric acid secretion. Quaternary ammonium compounds are sparingly lipid soluble and do not readily pass lipid membranes such as the blood brain barrier. Central effects are negligible.
","Pre-anesthetic Use:
+
+- Adults: 0.2 mg to 0.4 mg intravenously or intramuscularly before the induction of anesthesia. Alternatively, a dose of 0.004 to 0.005 mg/kg up to a maximum of 0.4 mg may be used. Larger doses may result in profound and prolonged antisialogogue effect, which may be unpleasant for the patient.
+- Children (1 month to 12 years of age): 0.004 to 0.008 mg/kg up to a maximum of 0.2 mg intravenously or intramuscularly before the induction of anesthesia. Larger doses may result in profound and prolonged antisialogogue effect which may be unpleasant for the patient.
+
+
Intraoperative Use: When used to treat arrhythmias associated with traction reflexes, the usual attempts should be made to determine the aetiology of the arrhythmia and the surgical or anesthetic manipulations necessary to correct parasympathetic imbalance should be performed.
+
+
+- Adults: In those situations where intraoperative use is indicated, a single dose of 0.2 to 0.4 mg (or 0.004 to 0.005 mg/kg up to a maximum of 0.4 mg) by intravenous injection should be used. This dose may be repeated if necessary.
+- Children (1 month to 12 years of age): In those situations where intraoperative use is indicated, a single dose of 0.004 to 0.008 mg/kg or up to a maximum of 0.2 mg by intravenous injection should be used. This dose may be repeated if necessary.
+
+
Reversal of Neuromuscular Blockade:
+
+- Adults: 0.2 mg intravenously per 1 mg neostigmine or the equivalent dose of pyridostigmine. Alternatively, a dose of 0.01-0.015 mg intravenously with 0.05 mg/kg neostigmine or equivalent dose of pyridostigmine. Glycopyrronium may be administered simultaneously from the same syringe with the anticholinesterase; greater cardiovascular stability results from this method of administration.
+- Children (1 month to 12 years of age): 0.01 mg/kg intravenously with 0.05 mg/kg neostigmine or the equivalent dose of pyridostigmine. Glycopyrronium may be administered simultaneously from the same syringe with the anticholinesterase; greater cardiovascular stability results from this method of administration.
+
+
",,"Many drugs have antimuscarinic effects; concomitant use of two or more of such drugs can increase side-effects such as dry mouth, urine retention and constipation. Concomitant use can also lead to confusion in the elderly. Anticholinergic agents may delay absorption of other medication given concomitantly. Concurrent administration of anticholingergics and corticosteroids may result in increased intraocular pressure. Concurrent use of anticholinergic agents with slow-dissolving tablets of digoxin may cause increased serum digoxin levels.
+
+- Ritodrine: tachycardia
+- Increased antimuscarinic side-effects: amantadine; tricyclic antidepressants; antihistamines; clozapine; disopyramaide; MAOIs; nefopam; pethidine; phenothiazines (increased antimuscarinic side effects of phenothiazines but reduced plasma concentrations)
+- Possibly increased antimuscarinic side-effects: tricyclic (related) antidepressants
+- Domperidone/Metoclopramide: antagonism of effect on gastro-intestinal activity
+- Ketoconazole: reduced absorption of ketoconazole
+- Levodopa: absorption of levodopa possibly reduced
+- Memantine: effects possibly enhanced by memantine
+- Nitrates: possibly reduced effect of sublingual nitrates (failure to dissolve under the tongue owing to dry mouth)
+- Parasympathomimetics: antagonism of effect
+
",,"Side effects of antimuscarinics such as glycopyrronium bromide are basically extensions of the fundamental pharmacological action. These include constipation, transient bradycardia (followed by tachycardia, palpitations and arrhythmias), reduced bronchial secretions, urinary urgency and retention, dilatation of the pupils with loss of accommodation, photophobia, dry mouth, flushing and dryness of the skin. Side effects that occur occasionally include confusion (particularly in the elderly), nausea, vomiting and giddiness. The following reported adverse reactions are extensions of glycopyrronium bromide’s fundamental pharmacological actions:
+
+- Cardiovascular: Tachycardia, ventricular fibrillation, bradycardia, palpitation and arrhythmia, hypertension, hypotension, cardiac arrest, heart block, prolonged QTc interval.
+- Dermatological: Flushing and inhibition of sweating, severe allergic reactions or drug idiosyncrasies including urticaria and other dermal manifestations, pruritus, dry skin.
+- Gastrointestinal: Nausea, vomiting, dry mouth, constipation, taste alterations, including loss of taste.
+- Genitourinary: Urinary hesitancy and retention, impotence.
+- Ocular: Blurred vision due to mydriasis, cycloplegia, photophobia, increased ocular tension.
+- Nervous System: Inhibition of transmission at neuromuscular junction, headache, nervousness, drowsiness, dizziness, seizure, insomnia, some degree of mental confusion, especially in the elderly, hyperexcitability in children.
+- Pregnancy and perinatal: Suppression of lactation.
+- Respiratory System: Respiratory arrest.
+- General: Hyperpyrexia bloated feeling, anaphylaxis/anaphylactoid reaction, and hypersensitivity. Injection site reactions including pruritus, oedema, erythema, pain have been reported rarely.
+
","Data on the use of glycopyrronium bromide in pregnant women, other than on delivery, are not forthcoming, nor is there documentation concerning excretion in breast milk. Although glycopyrronium bromide does not readily cross the placenta, the injection should only be prescribed to pregnant women when clearly necessary. Caution is advised when considering administration to a lactating mother.
","Antimuscarinics should be used with caution (due to increased risk of side effects) in Down’s syndrome, in children and in the elderly. They should also be used with caution in gastro-esophageal reflux disease, diarrhea, ulcerative colitis, acute myocardial infarction, hypertension, conditions characterized by tachycardia (including hyperthyroidism, cardiac insufficiency, cardiac surgery) because of the increase in heart rate produced by their administration, coronary artery disease and cardiac arrhythmias, pyrexia (due to inhibition of sweating), pregnancy and breast feeding. Because of prolongation of renal elimination, repeated or large doses of glycopyrronium bromide should be avoided in patients with uremia. Large doses of quaternary anticholinergic compounds have been shown to block end plate nicotinic receptors. This should be considered before using glycopyrronium bromide in patients with myasthenia gravis. It is known that the administration of anticholinergic agents during inhalation anesthesia can result in ventricular arrhythmias.
","Pediatric Use: Arrhythmias associated with the use of glycopyrronium bromide intravenously as a premedication or during anesthesia appear to be more likely in pediatric patients than in adults. Infants, patients with Down's syndrome and pediatric patients with spastic paralysis or brain damage may experience an increased response to anticholinergics, thus increasing the potential for side effects. A paradoxical reaction characterized by hyperexcitability may occur in pediatric patients taking large doses of anticholinergics including glycopyrronium bromide. Infants and young children are especially susceptible to the toxic effects of anticholinergics. Safety and effectiveness of long-term IV use has not been established in pediatric patients. Long-term use of Glycopyrronium is therefore not recommended in pediatric patients.
Elderly Use: Clinical studies of glycopyrronium bromide did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or drug therapy.
","Glycopyrronium bromide is a quaternary ammonium agent and symptoms of overdosage are peripheral rather than central in nature. Excessive peripheral anticholinergic effects may be countermanded by giving intravenously a quaternary ammonium anticholinesterase such as neostigmine methylsulphate in increments of 0.25 mg in adults. The dose may be repeated every 5-10 minutes until anticholinergic over-activity is reversed or up to a maximum of 2.5 mg. Proportionately smaller doses should be used in children.
",,,"Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+1466,Glycopyrronium Bromide (Inhalation capsule),glycopyrronium-bromide-inhalation-capsule-1466,https://medex.com.bd/attachments/WEBcSIyjWlauG60uV0HAQk9PNAWzjM/glycopyrronium-bromide-inhalation-capsule-prescribing-information,Bronchodilator,Emphysema,"Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
","Bronchodilator
","Glycopyrronium is a long-acting, specific antimuscarinic agent, in clinical medicine often called an anticholinergic. It has a similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, inhibition of M3-receptors at the smooth muscle results in relaxation. The high potency and slow receptor dissociation found its clinical correlate in significant and long-acting bronchodilation in patients with COPD.
","The recommended dosage of Glycopyrronium is the inhalation of the contents of one capsule once daily with the ConviHaler device at the same time of day.
",,"Although no formal drug interaction studies have been performed, Glycopyrronium inhalation powder has been used concomitantly with other drugs, commonly used in the treatment of COPD, including sympathomimetic bronchodilators, methylxanthines, oral and inhaled steroids without clinical evidence of drug interactions.
","Hypersensitivity to the active substance or to any of the excipients.
","Inhaled medicines may cause inhalation-induced bronchospasm, dehydration, dry mouth, constipation, dizziness, insomnia, skin and subcutaneous tissue disorders, immune system disorders.
","There is a limited amount of data from the use of Glycopyrronium in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant doses. Glycopyrronium should not be used in pregnant or nursing women unless the expected benefit outweighs any possible risk to the unborn child or the infant.
","Glycopyrronium, as a once-daily maintenance bronchodilator, should not be used for the initial treatment of acute episodes of bronchospasm, i.e. rescue therapy. Immediate hypersensitivity reactions may occur after administration of Glycopyrronium inhalation powder. As with other anticholinergic drugs, Glycopyrronium should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction.
",,"High doses of Glycopyrronium may lead to anticholinergic signs and symptoms. However, there were no systemic anticholinergic adverse effects following a single inhaled dose of up to 150 micrograms Glycopyrronium in healthy volunteers.
",,,"Should be stored at temperature not exceeding 25ºC but do not freeze. Should be stored in cool and dry place, protected from light.
",11
+533,Glycine,glycine-533,https://medex.com.bd/attachments/tWgrEwHvTL8PY7SXrbjRnUP96OZcSC/glycine-prescribing-information,Irrigation Solution used in Urological Surgery,Supports normal prostate function,"This is indicated as irrigating fluid of choice in:
+
+- Transurethral resection of prostate.
+- Endoscopic procedures within the urinary tract.
+- Urinary bladder surgery etc.
+
","Irrigation Solution used in Urological Surgery
","Glycine irrigation solution contains glycine which is an amino acid and a non-electrolyte. It is therefore non-conductive and suitable for irrigation purpose. Glycine Irrigation Solution minimizes the risk of intravascular haemolysis which can occur from absorption of plain water. Glycine Irrigation Solution is rapidly degraded in the liver by glycine oxidase.
","The total volume of solution used for irrigation depends on the judgment of the attending surgeon. Height from the operating table of 60 cm (approx. 2ft) is likely to cause increased intravascular absorption of glycine.
","Administration Procedure:
+
+- Check infusion set and infusion solution prior to use
+- Pull moderately to tear off the protective cover of the Eurohead
+- Hold lightly the Eurohead but not the bag
+- Open the flow regulator fully and hold the giving set on the top white area, but not the membrane venting region
+- Insert the spike of the administration set to the Eurohead and fit the connector of the administration set firmly to the needle
+- Gradually allow the fluid to flow down to the needle tip and close
+- Remove the protective cover of the needle
+- Locate the veinpuncture site and clean the site with an antiseptic solution, and then insert the needle
+- Securely tape the puncture site
+- Securely tape the wings and tubing
+- Start infusion while adjusting drip speed
+
","Additives may be incompatible. When introducing additives, use aseptic technique, mix thoroughly and do not store.
","Glycine Irrigation Solution is not for injection in any route. It is contraindicated in patients with anuria.
","Large intravenous doses of glycine are known to cause nausea and salivation. Other consequences of systemic absorption of glycine include electrolyte loss, diuresis, edaema, thirst, dehydration, cardiovascular and pulmonary disorders.
",,"Patients with cardiovascular disease should be evaluated after transurethral resection of prostate using glycine. Care should be exercised if the liver or kidney is impaired. Aseptic technique is essential while using glycine. Unused portion should be discarded. Do not use if the bottle is leaking, solution is cloudy, contains particles or after expiry date.
",,,,,"Store at controlled room temperature, protect from light and heat
",10
+530,Glycerol + Liquid Sugar,glycerol-liquid-sugar-530,,Combined cough suppressants,Sore throat,"Glycerol & Liquid Sugar is indicated in- relief of dry, irritating cough and sore throat. It also assists in relieving productive cough.
","Combined cough suppressants
","Glycerol is an osmotic dehydrating agent that possesses hygroscopic and lubricating properties. It causes plasma osmolality leading to the movement of water into the plasma from the extravascular spaces via osmosis.
","Adults including the elderly and children over 5 years: Two 5 ml spoonful (10 ml)
Children 1 to 5 years: One 5 ml spoonful (5 ml)
Children 3 month to 1 year: ½ to 1 spoonful (2.5 to 5 ml)
The dose should be repeated three or four times a day as required.
",,,"Hypersensitivity or intolerance to any of the ingredients.
","This medicine is unlikely to cause side effects unless the patient is allergic to the ingredients.
","The safety of this medicine during pregnancy and lactation has not been established, but is not considered to constitute a hazard during these periods.
","Diabetics should take note of the carbohydrate content of this product. Do not give to children under one year. Keep all medicines out of the reach of children.
",,"Over dosage would not be expected to cause any problems and treatment would be merely symptomatic and supportive.
",,,"Should be stored in a cool and dry place, protected from light.
",10
+552,Glycerol + Hypromellose + Polyethylene Glycol 400,glycerol-hypromellose-polyethylene-glycol-400-552,,Drugs for Dry eyes,Watery eye,"It is indicated for the symptomatic relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. It is also indicated for the treatment of keratoconjunctivitis sicca.
","Drugs for Dry eyes
","This eye drop is an almost colorless, clear aqueous lubricant sterile ocular solution administered to the eye(s). After topical application of this eye drop, it spreads rapidly over the conjunctiva and cornea forming a lubricating and protective film. Polyethylene Glycol 400 increases the stability of tear film and due to greater muco-adhesive properties hypromellose helps the tear film to attach with the ocular surface. Glycerin restores moisture to the dry eye. Electrolytes which are similar to the natural tears maintain good corneal epithelial surface.
","1 to 2 drops in the affected eye(s) up to 4 times daily.
",,"If several medicines are to be administered to the eye, there should be an interval of at least 5 minutes between each application.
","This eye drops is contraindicated in patients with known hypersensitivity to any ingredient of the product.
","Occasionally mild, transient burning or sticky sensation and very rarely irritation or hypersensitivity reactions reported. Blurred vision after application may occur.
","There is no experience regarding the safety of this eye drops in human pregnancy or lactation. If pregnant or breast feeding, ask a doctor before use.
","Remove contact lenses before using this drug. Do not use if this solution changes color or becomes cloudy. Don't touch tip of container to any surface to avoid contamination and replace cap after each use.
",,,,,"Store at room temperature. It is desirable that the contents should not be used more than 4 weeks after first opening of the bottle.
",10
+1620,Glycerol,glycerol-1620,,Miscellaneous topical agents,Skin irritations,"This Jelly is indicated to enhance the comfort and ease of intimate activity with or without latex condoms. This personal lubricant can be safely applied directly to a genital body orifice or a latex condom. The product can be used inside condoms to facilitate application or outside for lubrication during intercourses.
","Miscellaneous topical agents
",,"Apply the desired amount of lubricant to your intimate areas. Reapply as needed. This Jelly is not applicable for pediatric Use.
",,"Drug interaction-related data not found. If any abnormality consults with the doctor.
","This Jelly is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.
","No common side effects have been reported with this preparation. Few allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); new or worsening skin irritation may occur.
","It may feel strange to have sex as the baby grows within, but so long as you're having a normal, healthy pregnancy, intercourse is generally considered safe but be sure to consult with doctor if you have any questions about safety. Avoid use if pregnant unless prescribed by physician. No known risk found during the lactation period.
","Discontinue if irritation or discomfort occurs. Do not eat and keep the gel away from nose, eye and open wounds.
This Jelly is not a contraceptive and does not contain a spermicide. Keep out of reach of children and away from eyes and ears. Do not use if quality seal on the opening of the tube or bottle is broken or missing. Avoid use if pregnant or breast feeding unless prescribed by your doctor. Glycerol-based lubricants may slow sperm down, so if you're trying to have a baby, talk to your doctor before use.
",,,,,"Store at room temperature below 30°C. Do not freeze.
",9
+1479,Glycerin + Hypromellose + Polyethylene glycol + Tetrahydrozoline + Zinc Sulfate,glycerin-hypromellose-polyethylene-glycol-tetrahydrozoline-zinc-sulfate-1479,https://medex.com.bd/attachments/4adykrXIX1GQ3VBKMRW3pCNdlz1os1/glycerin-hypromellose-polyethylene-glycol-tetrahydrozoline-zinc-sulfate-prescribing-information,Other ophthalmic preparations,Skin infections,"This eye drop is indicated-
+
+- For the relief of discomfort and redness of the eye due to minor eye irritations.
+- Relieves dryness of the eye.
+- For the temporary relief of burning and irritation due to exposure to wind or sun.
+- For protection against further irritation.
+
","Other ophthalmic preparations
",,"
+- Put 1 to 2 drops in the affected eye(s) up to 4 times a daily
+- Children under 6 years of age: ask a doctor
+
",,,"Stop use and ask a doctor if
+
+- you feel eye pain
+- changes in vision occur
+- redness or irritation of the eye lasts
+- the condition worsens or lasts more than 72 hours
+
","Possible side effects include: temporary stinging or burning; redness, itching and watering of the eye
","If pregnant or breast-feeding, ask a health professional before use.
","When using this product-
+
+- pupils may become enlarged temporarily
+- overuse may cause more eye redness
+- remove contact lenses before using
+- do not use if this solution changes color or becomes cloudy
+- do not touch tip of container to any surface to avoid contamination
+- replace cap after each use
+
",,,,,"Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
",8
+531,Glycerin,glycerin-531,https://medex.com.bd/attachments/9jXQNbIqqm8RSDZcUkxDphvxIwNMtS/glycerin-prescribing-information,Osmotic purgatives,Lubrication,"Glycerin suppository is used for the relief of occasional constipation.
","Osmotic purgatives
","Glycerin is a hyperosmotic laxative, given rectally, which usually produces a bowel movement within 15 minutes to 1 hour. Hyperosmotic laxatives encourage bowel movements by drawing water into the bowel from surrounding tissues. This produces a softer stool mass and increases bowel action. These products are used for fast, predictable relief of occasional constipation.
","Children under 2 years: As directed by the physician.
Children (2 to 6 years): Only 1 Glycerin 1.15 Suppository per day or as directed by the physician.
Adults and Children (From 6 years): Only 1 Glycerin 2.30 Suppository per day or as directed by the physician
Insert suppository well up into the rectum. Suppository does not need to melt completely to produce laxative action.
",,,"Sensitivity to the ingredients. Do not use unless the patient to be treated is, in fact, constipated.
","When glycerin used rectally may cause rectal discomfort or a burning sensation.
","Pregnancy category C. There are no controlled data in human pregnancy.
",,,,,,"Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.
",8
+1889,Glucose 19% + Vamin 18 Novum + Intralipid 20%,glucose-19-vamin-18-novum-intralipid-20-1889,https://medex.com.bd/attachments/nQUkukn9VbpL65b23SDj1kwvSBuoQU/glucose-19-vamin-18-novum-intralipid-20-prescribing-information,Parenteral nutritional preparations,Parenteral nutrition,"This parenteral nutrition is indicated for patients and children above 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.
","Parenteral nutritional preparations
",,"The dose should be individualized and the choice of bag size should be made with regard to the patients clinical condition, body weight and nutritional requirements. To provide total parenteral nutrition, trace elements and vitamins should be given additionally.
Adult patients: The nitrogen requirements for maintenance of body protein mass depend on the patients condition (e.q. nutritional state and degree of catabolic stress). The requirements are 0.10-0.15 g nitrogen/kg/day in the normal nutritional state or in conditions with mild metabolic stress. In patients with moderate to high metabolic stress with or without malnutrition, the requirements are in the range of 0.15-0.30g nitrogen/kg/day (1.0-2.0 g amino acid/kg/day). The corresponding commonly accepted requirements are 2.0-6.0 g for glucose and 1.0-2.0g for fat. The dose range of 0.10-0.20 g nitrogen/kg/day (0.7-1.3 g amino acid/kg/day) which covers the need of the majority of the patients. This corresponds to 19 ml-38 ml/kg/day. For a 70-kg-patient this is equivalent to 1330 ml-2660 ml of this solution per day. The total energy requirement depends on the patient's clinical condition and is most often between 25 - 35 kcal/kg/ day. In obese patients the dose should be based on the estimated ideal weight. This solution is produced in four sizes intended for patients with high, moderately increased, basal, or low nutritional requirements. To provide total parenteral nutrition, trace elements and vitamins should be given additionally.
Children: The ability to metabolize individual nutrients must determine the dosage. In general the infusion for small children (2-10 years) should start with a low dose i.e. 12.5-25 ml/kg (corresponding to 0.49-0.98 g fat/kg/day,0.41-0.83 g amino acids/kg/day and 1.2-2.4 g glucose/kg/day) and increased by10-15ml/kg/day up to maximum dosage of 40 ml/kg/day. For children over 10 years of age, the dosage for adults can be applied. The use of this parenteral nutrition is not recommended in children under 2 years of age in whom the amino acid cysteine may be considered conditionally essential.
","Infusion rate: The maximum infusion rate for glucose is 0.25 g/kg/hour. Amino acid dosage should not exceed 0.1 g/kg/hour. Fat dosage should not provide more than 0.15 g/kg/hour. The infusion rate should not exceed 2.6 ml/kg body weight/hour (corresponding to 0.25 g glucose, 0.09 g amino acid and 0.1g fat/kg). The recommended infusion period is 12-24 hours. This parenteral nutrition is recommended to be infused only into a central vein. The infusion may be continued for as long as required by the patient's clinical condition.
",,"
+- Hypersensitivity to egg-, soya- or peanut protein or to any of the active substances or excipients. Severe hyperlipaemia
+- Severe liver insufficiency
+- Severe blood coagulation disorders
+- Inborn errors of amino acid metabolism
+- Severe renal insufficiency without access to haemofiltration or dialysis
+- Acute shock
+- Hyperglycemia, which requires more than 6 units insulin/h
+- Pathologically elevated serum levels of any of the included electrolytes.
+- General contra-indications to infusion therapy acute pulmonary oedema, hyper hydration and decompensated cardiac insufficiency and hypotonic dehydration
+- Haemophagocytotic syndrome
+- Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes, acute myocardial infarction, metabolic acidosis, severe sepsis and hyperosmolar coma)
+- Infants under 2 years of age
+
","Intralipid may cause a rise in body temperature (incidence <3%) and, less frequently, shivering, chills and nausea/vomiting (incidence <1%). Transient increases in liver enzymes during intravenous nutrition have also been reported. As with all hypertonic solutions for infusion, thrombophlebitis may occur if peripheral veins are used. Reports of other undesirable effects in conjunction with Intralipid infusions are extremely rare; less than one adverse event per million infusions. Hypersensitivity reactions (anaphylactic reaction, skin rash, urticaria), respiratory symptoms (e.g. tachypnoea) and hyper/hypotension have been described. Haemolysis, reticulocytosis, abdominal pain, headache, tiredness and priapism have been reported.
Fat overload syndrome: An impaired capacity to eliminate Intralipid (the fat component in this parenteral nutrition) may lead to the fat overload syndrome as a result of over-dosage, but also at recommended rates of infusion in association with a sudden change in the patients clinical condition, such as renal function impairment or infection. The fat overload syndrome is characterised by hyperlipidaemia, fever, fat infiltration, hepatomegaly, splenomegaly, anaemia, leucopenia, thrombocytopenia, blood coagulation disorders and coma. All symptoms are usually reversible if the infusion is discontinued.
",,"The ability to eliminate fat should be monitored. It is recommended that this is done by measuring serum triglycerides after a fat-free period of 5-6 hours. The serum concentration of triglycerides should not exceed 3 mmol/l during infusion. The bag size, especially the volume and the quantitative composition, should be carefully chosen. These volumes should be adjusted according to the hydration and nutritional status of the children. One reconstituted bag is for single use. Disturbances of the electrolyte and fluid balance (e g. abnormally high or low serum levels of the electrolytes) should be corrected before starting the infusion.
Special clinical monitoring is required at the beginning of any intravenous infusion. Should any abnormal sign occur, the infusion must be stopped. Since an increased risk of infection is associated with the use of any central vein, strict aseptic precautions should be taken to avoid any contamination during catheter insertion and manipulation.
This solution should be given with caution in conditions of impaired lipid metabolism due to renal insufficiency, uncompensated diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism (with hypertriglyceridemia or sepsis. If this solution is given to patients with these conditions, close monitoring of serum triglyceride concentrations is mandatory.
",,"Nausea, vomiting and sweating have been observed during infusion of amino acids at rates exceeding the recommended maximum rate. If symptoms of overdose occur, the infusion should be slowed down or discontinued. Additionally, an overdose might cause fluid overload, electrolyte imbalances, hyperglycemia, and hyperosmolality. In some rare serious cases, haemodialysis, haemofiltration or haemo diafiltration may be necessary.
",,,"Store at 25°C. Do not freeze. It is recommended to store.
",9
+1880,Glucose 11% + Vamin 18 Novum + Intralipid 20%,glucose-11-vamin-18-novum-intralipid-20-1880,https://medex.com.bd/attachments/3R1FxiE3m8KbCUNJ4Mqu6DvIYpUWQy/glucose-11-vamin-18-novum-intralipid-20-prescribing-information,Parenteral nutritional preparations,Negative nitrogen balance,"This parenteral nutrition is indicated for patients and children above 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.
","Parenteral nutritional preparations
",,"The dose should be individualized and the choice of bag size should be made with regard to the patient's clinical condition, body weight, and nutritional requirements
Adult patients: The nitrogen requirements for maintenance of body protein mass depend on the patient's condition (e.g. nutritional state and degree of catabolic stress). The requirements are 0.10-0.15 g nitrogen/kg/day in the normal nutritional state. In patients with moderate to high metabolic stress with or without malnutrition, the requirements are in the range of 0.15-030 g nitrogen/kg/day (1.0-2.0 g amino acid/kg/day); The corresponding commonly accepted requirements are 2-6 g for glucose and 1.0-2.0 g for fat.
The total energy requirement depends on the patient's clinical condition and is often between 20-30 kcal/kg/day In obese patients, the dose should be based on the estimated ideal weight. This solution is produced in three sizes intended for patients with moderately increased, basal or low nutritional requirements. To provide total parenteral nutrition, the addition of trace elements, vitamins and supplemental electrolytes may be required. The dose range of 0.10-0 15 g N/kg/day (0.7-1.0 g amino acid/kg/day) and total energy of 20-30 kcal body weight/day corresponds to approx. 27-40 ml/kg/day.
Children: The ability to metabolize individual nutrients must determine the dosage. In general the infusion for small children (2-10 years) should start with a low dose l.e. 14-28 ml/kg (corresponding to 0.49-0.98 g fat/kg/day, 0.34-0.67 g amino acids/kg/day and 0.95-1.9 g glucose/kg/day) and increased by 10-15 ml/kg/day up to maximum dosage of 40 ml/kg/day. For children over 10 years of age the dosage for adults can be applied. The use of this solution is not recommended in children under 2 years of age in whom the amino acid cysteine may be considered conditionally essential.
","Infusion rate: The maximum infusion rate for glucose is 0.25 g/kg/hour Amino acid dosage should not exceed 0.1 g/kg/hour Fat dosage should not provide more than 0.15 g/kg/hour The infusion rate should not exceed 3.7 ml/kg/hour (corresponding to 0.25 g glucose, 0.09 g amino acids, 0.13 g fat per kg body weight). The recommended infusion period for individual bags of this solution is 12-24 hours.
Method and duration of administration: Intravenous infusion into a Perifer or central vein. The infusion may be continued for as long as required by the patient's clinical condition. In order to minimize the risk of thrombophlebitis, daily rotation of the infusion site is recommended.
","The soybean oil present in this intravenous preparation has vitamin K1. Vitamin K1 can reverse the anticoagulant activity of coumarin and coumarin derivatives, including warfarin, which works by blocking recycling of vitamin K1. Monitor laboratory parameters for anticoagulant activity in patients who are on both this intravenous preparation and coumarin or coumarin derivatives.
","
+- Hypersensitivity to egg-, soya- or peanut protein or to any of the active substances or excipients. Severe hyperlipaemia
+- Severe liver insufficiency
+- Severe blood coagulation disorders
+- Inborn errors of amino acid metabolism
+- Severe renal insufficiency without access to haemofiltration or dialysis
+- Acute shock
+- Hyperglycemia, which requires more than 6 units insulin/h
+- Pathologically elevated serum levels of any of the included electrolytes.
+- General contra-indications to infusion therapy acute pulmonary oedema, hyper hydration and decompensated cardiac insufficiency and hypotonic dehydration
+- Haemophagocytotic syndrome
+- Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes, acute myocardial infarction, metabolic acidosis, severe sepsis and hyperosmolar coma)
+- Infants under 2 years of age
+
","The infusion may cause a rise in body temperature (incidence <3%) and, less frequently, shivering, chills and nausea/vomiting (incidence<1 %). Transient increases in liver enzymes during intravenous nutrition have also been reported. Reports of other undesirable effects in conjunction with the included components are extremely rare. Hypersensitivity reactions (anaphylactic reaction, skin rash, urticaria), respiratory symptoms (e.g. tachypnoea) and hyper/hypotension have been described. Haernolvsis. reticulocytosis, abdominal pain, headache, nausea, vomiting, tiredness and priapism have been reported.
",,"The ability to eliminate fat should be monitored. It is recommended that this is done by measuring serum triglycerides after a fat-free period of 5-6 hours. The serum concentration of triglycerides should not exceed 3 mmol/l during infusion. The bag size, especially the volume and the quantitative composition, should be carefully chosen. These volumes should be adjusted according to the hydration and nutritional status of the children. One reconstituted bag is for single use. Disturbances of the electrolyte and fluid balance (e g. abnormally high or low serum levels of the electrolytes) should be corrected before starting the infusion.
Special clinical monitoring is required at the beginning of any intravenous infusion. Should any abnormal sign occur, the infusion must be stopped. Since an increased risk of infection is associated with the use of any central vein, strict aseptic precautions should be taken to avoid any contamination during catheter insertion and manipulation.
This solution should be given with caution in conditions of impaired lipid metabolism due to renal insufficiency, uncompensated diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism (with hypertriglyceridemia or sepsis. If this solution is given to patients with these conditions, close monitoring of serum triglyceride concentrations is mandatory.
",,"Nausea, vomiting and sweating have been observed during infusion of amino acids at rates exceeding the recommended maximum rate. An impaired capacity to eliminate fat may lead to the fat overload syndrome as a result of overdosage, but also at recommended rates of infusion in association with a sudden change in the patient's clinical condition, such as renal function impairment or infection. The fat overload syndrome is characterised by hyperlipaemia, fever, fat infiltration, hepatomegaly, splenomegaly, anaemia, leucopenia, thrombocytopenia, blood coagulation disorders and coma. These changes are invariably reversible on discontinuation of the fat infusion If symptoms of overdose occur, the infusion should be slowed down or discontinued. In some rare serious cases, hemodialysis. haemofiltration or haemo-diafiltration may be necessary.
",,,"Store at 25°C. Do not freeze. It is recommended to store.
",10
+354,Glucosamine Sulfate + Diacerein,glucosamine-sulfate-diacerein-354,,Stimulation of Cartilage formation,Rheumatoid arthritis,"This tablet is indicated in-
+
+- Osteoarthritis
+- Rheumatoid arthritis
+- Bone and Joint injuries
+
","Stimulation of Cartilage formation
","Glucosamine: Glucosamine (2-amino-2-deoxy-alpha-D-glucose) is a natural amino sugar, produced by the body and found in certain foods. It is the most fundamental building block required for biosynthesis of glycosaminoglycans (GAGs) like Hyaluronic Acid, Keratan Sulfate and Chondroitin Sulfate. GAGs binds with protein and form proteoglycans, the essential building block of articular cartilage. When cartilage in a joint deteriorates, Osteoarthritis develops. It also helps to form ligaments, tendon, nails and various other connective tissues. When we take artificially synthesized Glucosamine Sulfate supplement, it increases Glucosamine level in the body, thus facilitates production and repair of cartilage. Glucosamine also activates chondrocytes in the cartilage which help produce GAGs and proteoglycans.
In humans, about 90 percent of glucosamine, administered as an oral dose of glucosamine sulfate, is absorbed from the digestive tract. Predominantly metabolized by liver & excreted through urine.
Diacerein: This is used for the treatment of Osteoarthritis. It has also analgesic, antipyretic and anti-inflammatory activity. It release in vitro and directly inhibits InterLeukin-1(IL-1) synthesis, which is the main cytokine involved in cartilage destruction. Due to specific mode of action, it have been shown to have disease-modifying effect in experimental models of osteoarthritis and in human subjects with finger joint and knee osteoarthritis.
Oral bioavailability of Diacerein 56%. Concurrent intake of food delays the time to peak concentration but associated with a 25% increase in absorption. Therefore, diacerein is best given with food. Mainly binds with protein albumin. Diacerein is metabolized extensively (100%) in liver following oral dosing. Urinary excretion of diacerein in the form of its metabolites has ranged between 35% and 60%.
","Use in adults: One tablet twice daily with food.
Use in children and adolescents: The safety and effectiveness of children and adolescents under the age of 18 years have not been established.
",,"Decrease absorption of Diacerein with aluminium and/ or magnesium hydroxide antacids. Increase risk of diarrhea with laxatives or antibiotics.
","Contraindicated for those who shows hypersensitivity to Glucosamine or Diacerein.
","No serious adverse effect has been reported. Nausea, vomiting, diarrhea, epigastria pain, headache, skin rashes & intense yellow coloring of urine may be occurred.
","This tablet is contraindicated during pregnancy and breastfeeding.
","Caution should be practised when administering this tablet in case of patients who are allergic to Glucosamine or Diacerein.
",,"There is no data available regarding overdose of this combination.
",,,"Store in cool & dry place below 30ºC, protect from light & moisture. Keep out of reach of children.
",11
+1613,Glucosamine Sulfate + Chondroitin + Camphor + Peppermint oil,glucosamine-sulfate-chondroitin-camphor-peppermint-oil-1613,,Topical Analgesics,Tendonitis,"This pain-relieving cream is applied topically and provides powerful pain relief of osteoarthritis pain, sprains, simple backache, tendonitis, minor arthritis pain.
","Topical Analgesics
","Glucosamine is sugar protein that is believed to help in developing and renewing cartilage and keep it lubricated for better joint movement and flexibility.
Chondroitin helps to maintain fluid and flexibility in the joints. The combination of chondroitin and glucosamine is widely used to aid in maintaining healthy joints. It is also used as a nutritional supplement in people with osteoarthritis or other inflammatory joint disorders.
Camphor is a strong smelling compound, chemically manufactured from turpentine oil. When applied to the skin, it stimulates nerve endings to relieve pain, itching and to relieve osteoarthritis.
Peppermint Oil is a strong smelling ingredient can be applied to the skin to treat muscle pain, nerve pain and joint pain.
","For the management of osteoarthritis the recommended dose is twice daily into painful muscle and joints for 2-4 week. Apply gently to painful muscles and joints, until this pain relieving cream disappears. Repeat as necessary.
",,"This medicine is not known to interact significantly with other medicines.
",,"There are no known systemic side effects unless people have an allergy or skin sensitivity to camphor or one of the inactive ingredients.
","It should not be used during pregnancy & lactation.
","Do not apply on broken or irritated skin or if excessive irritation develops. Do not bandage tightly or use a heating pad. Do not swallow. Avoid eye contact or mucous membranes.
",,,,,"Store in a cool and dry place, away from light. keep out of reach of children.
",9
+253,Glucosamine Sulfate + Chondroitin,glucosamine-sulfate-chondroitin-253,,Stimulation of Cartilage formation,"Vascular complications (e. g., atherosclerosis)","Indicated for the treatment of osteoarthritis of knee, hip, spine, hand, and other locations as a dietary supplement. It is also beneficial in rheumatoid arthritis, sport injuries, migraine, different skin problems (e.g., psoriasis), vascular complications (e. g., atherosclerosis), kidney stones, and inflammatory bowel disease (e.g., ulcerative colitis, leaky gut syndrome).
","Stimulation of Cartilage formation
","Glucosamine is a natural amino-sugar, produced by the body and found in certain foods. It is the most fundamental building block required for biosynthesis of glycosaminoglycans (GAGs) like Hyaluronic Acid, Keratan Sulfate, and Chondroitin Sulfate. GAGs binds with protein and form proteoglycans, the essential building block of articular cartilage. When cartilage in a joint deteriorates,Osteoarthritis develops. It also helps to form ligaments, tendon, nails, and various other connective tissues.When we take artificially synthesized Glucosamine Sulfate supplement, it increases Glucosamine level in the body, thus facilitates production and repair of cartilage. Glucosamine also activates chondrocytes in the cartilage which help produce GAGs and proteoglycans.
Chondroitin Sulfate is a glycosaminoglycan (acid muco polysaccharide) found in connective tissue, especially in the articular cartilage of all mammals. Chondroitin Sulfate supplement acts similarly as Glucosamine Sulfate, since it also provide substrate for proteoglycans. Chondroitin also protects existing healthy cartilage from premature decline by preventing the MMP (Matrix metalloproteinase) enzyme that breakdowns the proteoglycans.
Combining Glucosamine with Chondroitin Sulfate shows synergistic effect. Data supports that this combination has been shown to be very much effective in severe cases of Osteoarthritis that treats both sign and symptoms of Osteoarthritis & modifies disease progression. It prevents Osteoarthritis in case of normal adults. In Osteoarthritic pain it is as effective as NSAIDs with significantly better tolerability and clinical compliance. It is also helpful during the repair phase of musculo-skeletal soft tissue injuries such as tendon or ligament strains
","250/200 mg tablet: 1 to 2 tablets, three times daily. Dose may be adjusted according to the response of the drug and body weight. Doses can be tapered after 60 days as per requirement of the individual and for cost convenience. Typical dosage recommendation, based on body weight is as follows-
+
+- Under 54 Kg: 1000 mg Glucosamine Sulfate & 800 mg Chondroitin Sulfate per day
+- 54 Kg to 91 Kg: 1500 mg Glucosamine Sulfate & 1200 mg Chondroitin Sulfate per day
+- Over 91 Kg: 2000 mg Glucosamine Sulfate & 1600 mg Chondroitin Sulfate per day.
+
+
750/600 mg tablet: 1 tablet two times daily or as directed by the physician.
",,"There have been no reports of significant drug interactions of Glucosamine and Chondroitin with Antibiotics/ Antidepressants/ Antihypertensives/ Nitrates/ Antiarrythmics/ Anxiolytics/ Hypoglycemic agents/ Antisecretives/ Antiasthmatics. Chondroitin may enhance the blood thinning effects of anticoagulants like Warfarin, Heparin.
","There are no known contraindications for Glucosamine and Chondroitin. But proven hypersensitivity (e. g. allergic to shellfish or sulfur) to Glucosamine and Chondroitin is a contraindication.
","Safety studies with Glucosamine Sulfate & Chondroitin Sulfate show no demonstrable side effects. Rarely occurring side effects (such as, mild & reversible intestinal flatulence) are almost like placebo.
","Women who are pregnant or who could become pregnant should not supplement with Glucosamine Sulfate or Chondroitin Sulfate. Glucosamine and Chondroitin has not been studied enough to determine their effects on a developing fetus. No studies have evaluated the use of Glucosamine and Chondroitin during pregnancy or lactation. It should be taken with caution and medical advice during pregnancy and lactation.
","Patients with Diabetes Mellitus are advised to monitor blood glucose levels regularly when taking Glucosamine. No special studies were formed in patients with renal or hepatic insufficiency. The toxicological and pharmacokinetic profile of Glucosamine and Chondroitin does not indicate limitations for these patients. However, administration to patients with severe hepatic or renal insufficiency should be under appropriate medical supervision. Children should not be supplemented with Glucosamine and Chondroitin.
",,,,,"Store in a cool and dry place, protected from light.
",10
+529,Glucosamine Hydrochloride,glucosamine-hydrochloride-529,,Stimulation of Cartilage formation,Rheumatoid arthritis,"Indicated for the treatment of osteoarthritis of knee, hip, spine, and other locations. Also indicated as dietary supplement.
","Stimulation of Cartilage formation
","Glucosamine is a naturally occurring compound for the body's production of joint lubricants and shock absorbers necessary to maintain healthy cartilage and joint function. Glucosamine hydrochloride is a prodrug for glucosamine that is well absorbed after oral administration and diffuses into several tissues, including bones and articular cartilages. The active ingredient in the treatment of osteoarthritis is glucosamine. The hydrochloride acid salt is the delivery vehicle. Once it has entered the stomach, after oral administration the salt's job is done and it is the glucosamine that is released to perform its function.
Data supports Glucosamine as the first anti-osteoarthritic drug that treats both sign and symptoms of osteoarthritis & modifies disease progression. It is as effective as NSAIDs with significantly better tolerability and clinical compliances.
","500 mg tablet three times daily or as directed by the physician. A single dose of 1500 mg daily may also be effective. Obese individuals may need higher doses, based on body weight.
",,"There have been no reports of significant drug interactions of Glucosamine with antibiotics, antidepressants, antihypertensives, nitrates, antiarrhythmics, anxiolytic, hypoglycaemic agents, anti-secretives.
","There are no known contraindications for Glucosamine. But proven hypersensitivity to Glucosamine is a contraindication.
","Safety studies with Glucosamine show no demonstrable toxicity. Rarely occurring side effects like mild & reversible intestinal flatulence are almost like placebo.
","Women who are pregnant or who could become pregnant should not supplement with glucosamine. Glucosamine has not been studied enough to determine their effects on a developing fetus. And no studies have evaluated the use of Glucosamine during pregnancy or lactation. It should be taken with caution and medical advice during pregnancy and lactation.
","Diabetics are advised to monitor blood glucose levels regularly while taking Glucosamine. No special studies were formed in patients with renal and/or hepatic insufficiency. The toxicological and pharmacokinetic profile of the product does not indicate limitations for these patients. However, administration to these patients with severe hepatic or renal insufficiency should be under appropriate medical supervision.
",,,,,"Should be stored in cool and dry place.
",10
+528,Glipizide + Metformin Hydrochloride,glipizide-metformin-hydrochloride-528,https://medex.com.bd/attachments/hozSXdFvfE8nFCGgPWviK58E4AeTAG/glipizide-metformin-hydrochloride-prescribing-information,Combination Oral hypoglycemic preparations,Type 2 DM,"Glipizide & Metformin is indicated as initial therapy, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone and as second-line therapy when diet, exercise, and initial treatment ... Read more
Glipizide & Metformin is indicated as initial therapy, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone and as second-line therapy when diet, exercise, and initial treatment with a Sulfonylurea or Metformin do not result in adequate glycemic control in patients with type 2 diabetes
","Combination Oral hypoglycemic preparations
","Metformin is a biguanide antihyperglycemic agent, which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacological mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Unlike sulfonylurea, metformin does not produce hypoglycemia in either patient with type 2 diabetes or normal subjects and does not cause hyperinsulinemia.
Glipizide is a sulfonylurea which appears to lower blood glucose by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. Extrapancreatic effects may play a part in the mechanism of action of oral sulfonylurea hypoglycemic drugs.
","Glipizide & Metformin should be given once or twice daily with meals and should be initiated at a low dose, with gradual dose escalation.
Glipizide & Metformin as Initial Therapy: The recommended starting dose is 250 mg/2.5 mg once a day with meal.
Glipizide & Metformin as Second-Line Therapy: The recommended starting dose is 500 mg/2.5 mg or 500 mg/5 mg twice daily with the morning and evening meals. The maximum recommended daily dose is 2000 mg Metformin/20 mg Glipizide.
",,"Cimetidine reduces the renal clearance of Metformin. Alcohol potentiates the antihyperglycemic & hyperlactataemic effect of Metformin. It may enhance the effects of anti-coagulants. Such patients receiving the two drugs may need adjustment of the anti-coagulant dosage. Nifedipine appears to enhance the absorption of Metformin but Metformin has minimal effects on Nifedipine. The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including nonsteroidal anti-inflammatory agents, some azoles, and other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, monoamine oxidase inhibitors, and beta adrenergic blocking agents.
","Hypersensitivity to the drug, renal impairment, diabetic coma and ketoacidosis, chronic renal diseases, congestive heart failure, trauma, dehydration, alcohol dependence, pregnancy, breast-feeding etc.
","The most common side effects of Glipizide & Metformin are hypoglycemia,
diarrhea, nausea/vomiting, abdominal pain, headache, musculoskeletal pain etc.
","Contraindicated during Pregnancy & Lactation
","Metformin is known to be substantially excreted by the kidney, and the risk of Metformin accumulation and lactic acidosis is increased with the degree of impairment of renal function. Thus, patients with serum creatinine levels above the upper limit of normal should not receive Metformin. In patients with advanced age, Metformin should be carefully titrated to establish minimum dose for adequate glycemic control, because aging is associated with reduced renal function. Metformin therapy should be temporarily suspended for any surgical procedure and should not be restarted until the patient’s oral intake has resumed and renal function has been evaluated as normal. During concomitant therapy with sulfonylurea, blood glucose should be monitored. Metformin & insulin therapy should be carried out in hospital until the correct ratio of the two drugs has been established. The metabolism and excretion of Glipizide may be slowed in patients with impaired renal and/or hepatic function. If hypoglycemia should occur in such patients, it may be prolonged and appropriate management should be instituted.
",,,,,"Store below 25ºC in a cool and dry place.
",10
+527,Glipizide,glipizide-527,https://medex.com.bd/attachments/Khc6pRQ8Wnv1psOcin1QEGxmtuI9T0/glipizide-prescribing-information,Sulfonylureas,Type 2 DM,"Glipizide is indicated as an adjunct to diet for the control of hyperglycaemia and its associated symptomatology in the treatment of non-insulin-dependent diabetes mellitus (NIDDM type II) when diet modification has not been proved effective on its own. In certain patients who are receiving insulin ... Read more
Glipizide is indicated as an adjunct to diet for the control of hyperglycaemia and its associated symptomatology in the treatment of non-insulin-dependent diabetes mellitus (NIDDM type II) when diet modification has not been proved effective on its own. In certain patients who are receiving insulin, the concurrent use of Glipizide would allow a reduction in the daily dose of insulin.
Use of Glipizide must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, short term administration may be required if diet control alone results in transient control of blood glucose level.
During maintenance, if satisfactory lowering of blood glucose is no longer achieved, use of Glipizide should be discontinued.
","Sulfonylureas
","Glipizide lowers blood glucose by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells. The extrapancreatic effects of Glipizide are increase in insulin sensitivity and decrease in hepatic glucose production.
","Like any other oral hypoglycaemic agent, dosage of Glipizide is not fixed and may be adjusted through periodic monitoring of blood glucose level. Short term administration of Glipizide may be sufficient during periods of transient loss of control of blood glucose in patients, usually controlled well on diet.
In general, Glipizide should be given approximately 30 minutes before a meal to achieve the maximum reduction in postprandial hyperglycaemia.
+
+- Initial dose: The recommended starting dose is 5 mg, given before breakfast. Geriatric patients or those with liver disease may be started on 2.5 mg.
+- Dosage adjustments: Dosage adjustment may be done at intervals of several days by an increment of 2.5-5 mg, as determined by blood glucose response. If response to a single dose is not satisfactory, dividing that dose might prove effective. The maximum recommended once daily dose is 15 mg. Doses above 15 mg should ordinarily be divided and given before meals of adequate calorie content. The maximum recommended total daily dose is 40 mg.
+- Maintenance: Some patients may be effectively controlled on a once daily regimen, while others show better response with divided dosing. Total daily dose above 30 mg have been safely given on bid basis to long term patients. Patients can usually be stabilized on a dosage ranging from 2.5 to 30 mg daily.
+
+
In elderly, debilitated or malnourished patients, and patients with impaired renal or hepatic function: The initial and maintenance dosing should be conservative to avoid hypoglycaemic reactions.
Patients receiving insulin: Many stable non-insulin-dependent diabetic patients receiving Insulin may be safely placed on Glipizide if the physician decides to do so.
Patients receiving other oral hypoglycaemic agents: As with other sulphonylurea, no transition period is necessary while transferring patients to Glipizide. Patients should be observed carefully for any possible hypoglycaemic effect due to overlapping of drug effects.
Pediatric Use: Safety and effectiveness in children have not been established.
",,"The hypoglycaemic action of sulphonylurea may be potentiated by certain drugs including non-steroidal anti inflammatory agents and other drugs that are highly protein bound e.g., Salicylates, Sulphonamides, Chloramphenicol, Probenecid, Coumarins, Monoamine Oxidase Inhibitors, and β adrenergic blocking agents. When such drugs are administered to a patient receiving Glipizide, the patients should be observed closely for hypoglycaemia. When such drugs are withdrawn from a patient receiving Glipizide, the patient should be observed closely for loss of control on blood glucose.
Certain drugs tend to produce hyperglycaemia and may lead to loss of control on blood glucose. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, oestrogens, oral contraceptives, Phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs and Isoniazid. When such drugs are administered to or withdrawn from a patient receiving Glipizide, the patient should be closely observed for loss of control on blood glucose. Diabetic control may be altered also in patients treated with cyclophosphamide.
","Glipizide is contraindicated in the following conditions :
+
+- Patients who are hypersensitive to Glipizide or any component of the product
+- Juvenile onset diabetes
+- Severe or unstable ‘brittle’ diabetes
+- Diabetes complicated by ketosis and acidosis, major surgery, severe sepsis or severe trauma
+- Severe renal, hepatic or thyroid impairment, co-existent renal and hepatic disease
+
","The majority of side effects have been dose related, transient, and responded to dose reduction or withdrawal of the medication.
Gastrointestinal: Gastrointestinal complaints were reported with the following approximate incidences like nausea, diarrhoea, constipation and gastralgia. They appear to be dose related and usually disappear on division or reduction of dosage. Cholestatic jaundice may occur rarely with these kind of drugs and Glipizide should be discontinued if this occurs.
Dermatological: Allergic skin reactions including erythema, morbilliform or maculopapular eruption, urticaria, pruritus and eczema have been reported. They frequently disappear with continued therapy. However, if they persist, the drug should be discontinued.
Haematologic: Leucopenia, agranulocytosis, thrombocytopenia, haemolytic anaemia, aplastic anaemia and pancytopenia have been reported with sulphonylureas.
Metabolic: Hepatic porphyria and disulphiram like reactions have been reported with sulphonylurea.
Endocrine reactions: Cases of hyponatraemia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion have been reported with this and other sulphonylureas.
Miscellaneous: Dizziness, drowsiness and headache have been reported in patients treated with Glipizide. They are usually transient and seldom require discontinuation of therapy.
","Pregnancy: Glipizide should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Prolonged severe hypoglycaemia (4-10 days) has been reported in neonates born to mothers who were receiving sulphonylurea (e.g., Glipizide) at the time of delivery. So, if Glipizide is used during pregnancy, it should be discontinued at least one month before the expected delivery date.
Lactation: Although it is not known whether Glipizide is excreted in human milk, some sulphonylurea drugs are known to be so. Breast feeding is not therefore recommended while taking this medication.
","Hypoglycaemia: All sulphonylurea drugs are capable of producing severe hypoglycaemia. Proper patient selection, dosage and instructions are important to avoid hypoglycaemic episodes. Renal or hepatic insufficiency may cause elevated blood levels of Glipizide and the latter may also diminis gluconeogenic capacity, both of which increase the risk of serious hypoglycaemic reactions. Elderly, debilitated or malnourished patients and those with adrenal or pituitary insufficiency are particularly susceptible to the hypoglycaemic actions of glucose lowering drugs. Patients should be instructed to take their meals regularly and not to exercise excessively without additional calorie intake.
Renal and hepatic disease: The metabolism and excretion of Glipizide may be slowed in patients with impaired renal and/or hepatic function. These patients may suffer from prolonged hypoglycaemia and appropriate measures should be instituted.
Loss of control on blood glucose: When a patient stabilized on any antidiabetic regimen is exposed to stress such as fever, trauma, infection or surgery, a loss of control on blood glucose may occur. At that time it may be necessary to discontinue Glipizide and administer Insulin.
The effectiveness of any oral hypoglycaemic drug including Glipizide, in lowering blood glucose to a desired level, decreases in many patients over a period of time, which may be due to secondary failure, i.e., progression of the severity of the diabetes or diminished responsiveness to the drug.
",,,,,"The tablets should be protected from moisture and humidity and stored at room temperature (below 30° C).
",10
+1471,Glimepiride + Metformin,glimepiride-metformin-1471,https://medex.com.bd/attachments/GC14PEVnWMsBH5ypt4CAzgvnwpygU0/glimepiride-metformin-prescribing-information,Combination Oral hypoglycemic preparations,Type 2 DM,"This tablet is indicated as an adjunct to diet and exercise in type 2 diabetes mellitus patients-
+
+- In case that the monotherapy with glimepiride or metformin does not result in adequate glycemic control.
+- Replacement of combination therapy of glimepiride and metformin.
+
","Combination Oral hypoglycemic preparations
","Glimepiride is a sulfonylurea antidiabetic agent which decreases blood glucose concentration. The primary mechanism of action of Glimepiride appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. Glimepiride acts in concert with glucose by improving the sensitivity of beta cells to physiological glucose stimulus, resulting in insulin secretion. In addition, extrapancreatic effects like reduction of basal hepatic glucose production, increased peripheral tissue sensitivity to insulin and glucose uptake may also play role in the activity of Glimepiride. In non-fasting diabetic patients, the hypoglycaemic action of a single dose of Glimepiride persists for 24 hours.
Metformin Hydrochloride is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin Hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
","
+- The dosage of this tablet is governed by the desired blood glucose level. The dosage of this tablet must be the lowest which is sufficient to achieve the desired metabolic control. During treatment with this tablet glucose levels in blood and urine must be measured regularly.
+- Mistakes, e.g. forgetting to take a dose, must never be corrected by subsequently taking a larger dose.
+- As an improvement in control of diabetes is, in itself, associated with higher insulin sensitivity, glimepiride requirements may fall as treatment proceeds. To avoid hypoglycaemia timely dose reduction or cessation of this tablet therapy must therefore be considered.
+- The highest recommended dose per day should be 8 mg of glimepiride and 2000 mg of metformin.
+- In order to avoid hypoglycaemia the starting dose of this tablet should not exceed the daily doses of glimepiride or metformin already being taken.
+- When switching from combination therapy of glimepiride plus metformin as separate tablets, this combination should be administered on the basis of dosage currently being taken.
+
","This tablet must be swallowed whole and not crushed or chewed.
","For Glimepiride:
+
+- Glimepiride is metabolized by cytochrome P450 2C9 (CYP2C9). This should be taken into account when glimepiride is coadministered with inducers (e.g. rifampicin) or inhibitors (e.g. fuconazole) of CYP 2C9.
+- Potentiation of the blood-glucose-lowering efect and, thus, in some instances hypoglycaemia may occur when one of the following drugs is taken, for example: insulin and other, oral antidiabetics; ACE inhibitors; anabolic steroids and male sex hormones; chloramphenicol; coumarin derivatives; cyclophosphamide; disopyramide; fenfuramine; fenyramidol; fbrates; fuoxetine; guanethidine; ifosfamide; MAO inhibitors; miconazole; fuconazole; para-aminosalicylic acid; pentoxifylline (high dose parenteral); phenylbutazone; azapropazone; oxyphenbutazone; probenecid; quinolones; salicylates; sulfnpyrazone; clarithromycin; sulfonamide antibiotics; tetracyclines; tritoqualine; trofosfamide.
+- Weakening of the blood-glucose-lowering efect and, thus raised blood glucose levels may occur when one of the following drugs is taken, for example: acetazolamide; barbiturates; corticosteroids; diazoxide; diuretics; epinephrine (adrenaline) and other sympathomimetic agents; glucagon; laxatives (after protracted use); nicotinic acid (in high doses); oestrogens and progestogens; phenothiazines; phenytoin; rifampicin; thyroid hormones.
+- H2 receptor antagonists, beta-blockers, clonidine and reserpine may lead to either potentiation or weakening of the blood-glucose-lowering efect. Under the infuence of sympatholytic drugs such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation to hypoglycaemia may be reduced or absent.
+- Both acute and chronic alcohol intake may potentiate or weaken the blood-glucose-lowering action of glimepiride in an unpredictable fashion.
+- The efect of coumarin derivatives may be potentiated or weakened.
+- Bile acid sequestrant: Colesevelam binds to glimepiride and reduces glimepiride absorption from the gastrointestinal tract. Glimepiride should be administered at least 4 hours prior to colesevelam.
+
+For Metformin: Concomitant use not recommended:
+
+- Alcohol: Alcohol intoxication is associated with an increased risk of lactic acidosis, particularly in case of fasting, malnutrition or hepatic insufciency. Avoid consumption of alcohol and alcohol-containing medications
+- Iodinated contrast agents: Metformin must be discontinued prior to, or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable.
+- Combinations requiring precautions for use: Some medicinal products can adversely afect renal function which may increase the risk of lactic Acidosis. When starting or using such products in combination with metformin, close monitoring of renal function is necessary. Glucocorticoids, beta-2-agonists, and diuretics have intrinsic hyperglycemic activity. Inform the patient and perform more frequent blood glucose monitoring. ACE-inhibitors may decrease the blood glucose levels. Metformin may decrease the anticoagulant efect of phenprocoumon. Therefore, a close monitoring of the INR is recommended. Levothyroxine can reduce the hypoglycemic efect of metformin. Monitoring of blood glucose levels is recommended, especially when thyroid hormone therapy is initiated or stopped, and the dosage of metformin must be adjusted if necessary.
+
+Organic cation transporters (OCT): Metformin is a substrate of both transporters OCT1 and OCT2. Co-administration of metformin with:
+
+- Inhibitors of OCT1 (such as verapamil) may reduce efcacy of metformin.
+- Inducers of OCT1 (such as rifampicin) may increase gastrointestinal absorption and efcacy of metformin.
+- Inhibitors of OCT2 (such as cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole) may decrease the renal elimination of metformin and thus lead to an increase in metformin plasma concentration.
+- Inhibitors of both OCT1 and OCT2 (such as crizotinib, olaparib) may alter efcacy and renal elimination of metformin.
+
+Caution is therefore advised, especially in patients with renal impairment, when these drugs are coadministered with metformin, as metformin plasma concentration may increase. If needed, dose adjustment of metformin may be considered as OCT inhibitors/inducers may alter the efcacy of metformin.
","For Glimepiride-
+
+- In patients hypersensitive to glimepiride, metformin, other sulfonylureas, other sulfonamides, or any of the excipients of Amaryl M.
+- In pregnant women.
+- In breastfeeding women.
+
+No experience has been gained concerning the use of glimepiride in patients with severe impairment of liver function and in dialysis patients. In patients with severe impairment of hepatic function, change-over to insulin is indicated, not least to achieve optimal metabolic control.
For Metformin-
+
+- Hypersensitivity to metformin or any of the excipients.
+- Any type of acute metabolic acidosis such as lactic acidosis Diabetic ketoacidosis, diabetic pre-coma.
+- Severe Renal failure or renal disfunction (e.g., serum creatine levels >135 μmol/L in males and >110 μmol/L in females), GFR < 30 mL/min.
+- Acute conditions with the potential to alter renal function such as Dehydration, severe infection, intravascular administration of iodinated contrast agents etc.
+- Acute or chronic disease which may cause tissue hypoxia such as cardiac or respiratory failure, recent myocardial infarction, shock
+- Hepatic insufciency.
+- Acute alcohol intoxication, alcoholism.
+- Lactation.
+
","For Glimepiride:
Metabolism and nutrition disorders-
+
+- As a result of the blood-glucose-lowering action of glimepiride, Hypoglycaemia which may also be prolonged.
+- The clinical picture of a severe hypoglycaemic attack may resemble that of a stroke.
+
+Eye disorders: Especially at the start of treatment, there may be temporary visual impairment due to the change in blood glucose levels. The cause is a temporary alteration in the turgidity and hence the refractive index of the lens, this being dependent on blood glucose level.
Gastrointestinal disorders-
+
+- Occasionally, Gastrointestinal symptoms such as nausea, vomiting, sensations of pressure or fulness in the epigastrium, abdominal pain and diarrhea may occur.
+- In isolated cases, there may be hepatitis, elevation of liver enzyme levels and/or cholestasis and jaundice, which may progress to life-threatening liver failure.
+- Dysgeusia (frequency not known)
+
+Blood and lymphatic system disorders-
+
+- Changes in the blood picture may occur: Rarely, thrombocytopenia and, in isolated cases, leucopenia, hemolytic anemia, erythrocytopenia, granulocytopenia, agranulocytosis or pancytopenia may develop. Cases of severe thrombocytopenia with platelet count less than 10,000/μl and thrombocytopenic purpura have been reported in post-marketing experience (frequency not known).
+
+Skin and subcutaneous tissue disorders: Alopecia (frequency not known)
General disorders-
+
+- Occasionally, Allergic or pseudo allergic reactions may occur, e.g. in the form of itching, urticaria or rashes. Such mild reactions may develop into serious reactions with dyspnoea and a fall in blood pressure, sometimes progressing to shock.
+- In isolated cases, a decrease in serum sodium concentration and allergic vasculitis or hypersensitivity of the skin to light may occur.
+
+Investigations: Glimepiride, like all sulfonylureas, can cause weight gain (frequency not known)
For Metformin:
+
+- Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite (>10%) are very common. These occur most frequently during initiation of therapy and resolve spontaneously in most cases.
+- Metallic taste (3%) is common
+- Decrease of vitamin B12 absorption with decrease of serum levels has been observed in patients treated long-term with metformin and appears generally to be without clinical signifcance (<0.01%). However, Cases of peripheral neuropathy in patients with vitamin B12 defciency have been reported in post-marketing experience (frequency not known). (frequency unknown)
+- Lactic acidosis (0.03 cases/1000 patient-years) is very rare
+- Hemolytic anemia (frequency unknown)
+- Reduction of thyrotropin level in patients with hypothyroidism (frequency unknown)
+- Hypomagnesemia in the context of diarrhea (frequency unknown)
+- Encephalopathy (frequency unknown)
+- Photosensitivity (frequency unknown)
+- Hepatobiliary disorders: Reports of liver function tests abnormalities and hepatitis resolving upon metformin discontinuation
+
","Pregnancy-
+
+- For Glimepiride: Glimepiride must not be taken during pregnancy. Otherwise, there is risk of harm to the child. The patient must change over to insulin during pregnancy. Patients planning a pregnancy must inform their physician. It is recommended that such patients change over to insulin.
+- For Metformin: When the patient plans to become pregnant and during pregnancy, diabetes should not be treated with metformin but insulin should be used to maintain blood glucose levels as close to normal as possible in order to lower the risk of fetal malformations associated with abnormal blood glucose levels.
+
+Lactation-
+
+- For Glimepiride: To prevent possible ingestion with the breast milk and possible harm to the child, glimepiride must not be taken by breast-feeding women. If necessary the patient must change over to insulin, or must stop breastfeeding.
+- For Metformin: Metformin is excreted into milk in lactating rats. Similar data is not available in humans and a decision should be made whether to discontinue nursing or to discontinue metformin, taking into account the importance of the compound to the mother.
+
","For Glimepiride: In the initial weeks of treatment, the risk of hypoglycemia may be increased and necessitates especially careful monitoring. If risk factors for hypoglycemia are present, it may be necessary to adjust the dosage of glimepiride or the entire therapy. This also applies whenever illness occurs during therapy or the patient's life-style changes. It is known from other sulfonylureas that, despite initially successful countermeasures, hypoglycaemia may recur. Patients must, therefore, remain under close observation. Severe hypoglycaemia further requires immediate treatment and follow-up by a physician and, in some circumstances, in-patient hospital care. Treatment of patients with G6PD-defciency with sulfonylurea agents can lead to hemolytic anaemia. Since glimepiride belongs to the class of sulfonylurea agents, caution should be used in patients with G6PD-defciency and a non-sulfonylurea alternative should be considered.
For Metformin: Regular monitoring of thyroid-stimulating hormone (TSH) levels is recommended in patients withhypothyroidism. Long-term treatment with metformin has been associated with a decrease in vitamin B12 serumlevels which may cause peripheral neuropathy. Monitoring of the vitamin B12 level is recommended.
","Children: Data is insufficient to recommend pediatric use of this tablet.
Renal impairment: A GFR should be assessed before initiation of treatment with metformin-containing products and at least annually thereafter. In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months. The maximum daily dose of metformin should preferably be divided into 2-3 daily doses. Factors that may increase the risk of lactic acidosis should be reviewed before considering the initiation of metformin in patients with GFR<60 mL/min. If no adequate strength of this tablet is available, individual monocomponents should be used instead of the fixed dose combination.
GFR 60-89 ml/min:
+
+- Metformin: Maximum daily dose is 3000 mg. Dose reduction may be considered in relation to declining renal function.
+- Glimepiride: The highest recommended dose per day should be 8 mg of glimepiride.
+
+GFR 45-59 ml/min:
+
+- Metformin: Maximum daily dose is 2000 mg. The starting dose is at most half of the maximum dose.
+
+GFR 30-44 ml/min:
+
+- Metformin: Maximum daily dose is 1000 mg. The starting dose is at most half of the maximum dose.
+
+GFR <30 ml/min:
+
+- Metformin: Metformin is contraindicated
+- Glimepiride: Change-over to insulin is indicated, not least to achieve optimal metabolic control.
+
","For Glimepiride: Acute overdosage, as well as long-term treatment with too high a dose of glimepiride, may lead to severe life-threatening hypoglycaemia. As soon as an overdose of glimepiride has been discovered, a physician must be notifed without delay. The patient must immediately take sugar, if possible in the form of glucose unless a physician has already undertaken responsibility for treating the overdose. Careful monitoring is essential until the physician is confdent that the patient is out of danger. It must be remembered that hypoglycaemia may recur after initial recovery. Admission to hospital may sometimes be necessary even as a precautionary measure. In particular, signifcant overdoses and severe reactions with signs such as loss of consciousness or other serious neurological disorders are medical emergencies and require immediate treatment and admission to hospital. If, for example, the patient is unconscious, an intravenous injection of concentrated glucose solution is indicated (for adults starting with 40 ml of 20% solution, for example). Alternatively in adults, administration of glucagon, e.g. in doses of 0.5 to 1 mg i.v., s.c. or i.m., may be considered. In particular when treating hypoglycaemia due to accidental intake of glimepiride in infants and young children, the dose of glucose given must be very carefully adjusted in view of the possibility of producing dangerous hyperglycaemia, and must be controlled by close monitoring of blood glucose. Patients who have ingested life-threatening amounts of glimepiride require detoxifcation (e.g. by gastric lavage and medicinal charcoal). After acute glucose replacement has been completed it is usually necessary to give an intravenous glucose infusion in lower concentration so as to ensure that the hypoglycaemia does not recur. The patient's blood glucose level should be carefully monitored for at least 24 hours. In severe cases with a protracted course, hypoglycaemia, or the danger of slipping back into hypoglycaemia, may persist for several days.
For Metformin: Hypoglycaemia has not been seen with metformin doses of up to 85 g, although Lactic acidosis has occurred in such circumstances. High overdose or concomitant risks of metformin may lead to lactic acidosis Lactic acidosis is a medical emergency and must be treated in hospital. The most efective method to remove lactate and metformin is haemodialysis. Pancreatitis may occur in the context of a metformin overdose.
",,,"Store in a cool (not exceeding 25°C) and dry place, protected from light.
",13
+524,Glimepiride,glimepiride-524,https://medex.com.bd/attachments/RmTCJqI2VVHzRQhHRA08OFFMSfJlAP/glimepiride-prescribing-information,Sulfonylureas,Type 2 DM,"Glimepiride is indicated in following conditions-
+
+- Glimepiride is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin dependent (Type II) diabetes mellitus (NIDDM) whose hyperglycaemia cannot be controlled by diet and exercise alone.
+- Glimepiride may be used concomitantly with metformin when diet, exercise, and Glimepiride or metformin alone does not result in adequate glycaemic control.
... Read more
Glimepiride is indicated in following conditions-
+
+- Glimepiride is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin dependent (Type II) diabetes mellitus (NIDDM) whose hyperglycaemia cannot be controlled by diet and exercise alone.
+- Glimepiride may be used concomitantly with metformin when diet, exercise, and Glimepiride or metformin alone does not result in adequate glycaemic control.
+- Glimepiride is also indicated for use in combination with insulin to lower blood glucose in patients whose hyperglycaemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycaemic agent.
+- Combined use of Glimepiride and insulin may increase the potential for hypoglycaemia.
+
","Sulfonylureas
","Glimepiride is a sulfonylurea antidiabetic agent which decreases blood glucose concentration. The primary mechanism of action of Glimepiride appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. Glimepiride acts in concert with glucose by improving the sensitivity of beta cells to physiological glucose stimulus, resulting in insulin secretion. In addition, extrapancreatic effects like reduction of basal hepatic glucose production, increased peripheral tissue sensitivity to insulin and glucose uptake may also play role in the activity of Glimepiride. In non-fasting diabetic patients, the hypoglycaemic action of a single dose of Glimepiride persists for 24 hours.
","In principle, the dosage of Glimepiride is governed by the desired blood sugar level. The dosage of Glimepiride must be the lowest which is sufficient to achieve the desired metabolic control. The initial and the maintenance doses are set based on the results of regular check of glucose in blood and urine. Monitoring of glucose levels in blood and urine also serves to detect either primary or secondary failure of therapy.
Initial dose and dose titration: the usual initial dose is 1 mg once daily, if necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of 1 to 2 weeks, and carried out stepwise, as follows: 1 mg -> 2 mg -> 3 mg -> 4 mg -> 6 mg.
Dose in patients with well controlled diabetes: the usual dose range in patients with well controlled diabetes is 1 to 4 mg daily.
Distribution of doses: Timing and distribution of doses are decided by the physician, in consideration of the patient's current life-style. Normally, a single daily dose is sufficient. This should be taken immediately before a substantial breakfast or if none is taken immediately before the first main meal. It is very important not to skip meals after taking the drug.
Secondary dosage adjustment: As control of diabetes improves, sensitivity to insuiin increases; therefore, Glimepiride requirement may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Glimepiride therapy must be considered. A dose adjustment must also be considered whenever the patient's weight or life-styie changes, or other factors arise which cause an increased susceptibility to hypo or hyperglycaemia.
Changeover from other oral antidiabetics to Glimepiride: There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When substituting Glimepiride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from maximum dose of other oral blood sugar lowering agents. Any dose increase should be in accordance with guideline given above in 'initial dose and dose titration'. Consideration must be given to the potency and duration of action of the previous blood sugar lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia.
","Glimepiride tablet must be swallowed with sufficient amount of liquid.
","Based on experience with Glimepiride and known interactions for other sulfonylureas, the following interactions must be considered.
In addition to insulin and other oral antidiabetic agents, drugs which may potentiate the hypoglycaemic action of Glimepiride include: ACE inhibitors, aminosalicylic acid, anabolic steroids and male sex hormones, azapropazone, chloramphenicol, ciofibrate, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluconazole, fluoxetine, guanethidine, ifosfamide, MAO-inhibitors, miconazole, oxpentifylline (high dose parenteral), oxyphenbutazone, para-aminosalicylic acid, phenylbutazone, probenecid, quinolones, salicylates, sulphinpyrazone, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide.
Drugs which may attenuate the hypoglycaemic action of Glimepiride include:
+
+- Acetazoiamide, barbiturates, calcium channel blockers, corticosteroids, diazoxide, diuretics, glucagon, isoniazid, laxatives, nicotinic acid (high doses), oestrogens, phenothiazines, phenytoin, progestagens, rifampicin, sympathomimetic agents, thyroid hormones.
+- H2 receptor antagonists, beta-blockers, clonidine and reserpine may lead to either potentiation or weakening of the blood-glucose-lowering effect.
+- Concomitant treatment with a beta-receptor blocker, clonidine, guanethidine or reserpine may mask the warning symptoms of a hypoglycaemic attack.
+- Acute and chronic aicohol intake may either potentiate or attenuate the activity of Glimepiride in an unpredictable fashion.
+
","Glimepiride is not suitable for the treatment of insulin dependent (type I) diabetes mellitus, or for the treatment of diabetic ketoacidosis, nor for the treatment of diabetic coma. Glimepiride must not be used in patients hypersensitive to Glimepiride, other sulfonylureas, other sulfonamides, severe hepatic dysfunction, severe impairment of renal function and dialysis patients.
","Hypoglycaemia, temporary visual impairment, nausea, vomiting, diarrhoea, abdominal pain, urticaria, fall in blood pressure.
","Glimepiride must not be taken during pregnancy; a changeover to insulin is necessary. Patients planning a pregnancy must inform their physician, and should change over to insulin. Ingestion of Glimepiride with breast milk feeding may harm the child. Therefore, Glimepiride must not be taken by breastfeeding women. Either a changeover or complete discontinuation of breastfeeding is necessary.
","in the initial weeks of treatment, the risk of hypoglycaemia may be increased and necessitates careful monitoring. If such risk present it may be necessary to adjust the dosage of Glimepiride, Hypoglycaemia can almost be promptly controlled by immediate intake of carbohydrates (glucose or sugar).
",,"Overdosage of sulfonylureas, including Glimepiride, can produce hypoglycaemia. Mild hypoglycaemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycaemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medicai emergencies requiring immediate hospitalization. If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dl. Patients should be closely monitored for a minimum of 24 to 48 hours, because hypoglycaemia may recur after apparent clinical recovery.
",,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",12
+523,Gliclazide,gliclazide-523,https://medex.com.bd/attachments/NX3F3qrpcdNOt3IbtUVAXOApOdlfqJ/gliclazide-30-mg-60-mg-prescribing-information,Sulfonylureas,Type 2 DM,"Gliclazide is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulphonylurea group). Gliclazide is used in a certain form of diabetes (type 2 diabetes Mellitus) in adults, when diet, exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level.
","Sulfonylureas
","Gliclazide is a second generation sulfonylurea drug that has hypoglycaemic and potentially useful hematological properties. It stimulates the release of insulin from pancreatic β-cells by facilitating Ca+2 transport across the β-cell membranes and decreases hepatic glucose output.
","Film-coated tablet: The usual initial dose is 40 to 80 mg daily. The dose can be increased up to 320 mg daily in divided doses when needed. The drug should be taken before meal. For children, Gliclazide is not used because it is contraindicated in juvenile-onset diabetes.
Modified release preparation: Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dose is determined by the doctor, depending on your blood and possibly urine sugar levels. Change in external factors (weight reduction, lifestyle, stress) or improvements in the blood sugar control may require changed gliclazide doses.
The recommended daily dose is one to four tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment. Gliclazide MR tablet is for oral use. Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day). Swallow your whole tablet(s) in one piece. Do not chew or crush. You must always eat a meal after taking your tablet(s).
If a combination therapy of gliclazide with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor a GLP-1 receptor agonist or insulin is initiated your doctor will determine the proper dose of each medicine individually for you. If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you should contact your doctor or pharmacist.
If you take more Gliclazide tablets than you should: If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately. The signs of overdose are those of low blood sugar (hypoglycaemia). The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the emergency services. The same should be done if somebody, (for instance a child), has taken the product unintentionally. Unconscious patients must not be given food or drink. It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.
If you forget to take Gliclazide tablet: It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Gliclazide MR tablet, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Gliclazide MR tablet: As the treatment for diabetes is usually lifelong, you should discuss with your doctor before stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia) which increases the risk of developing complications of diabetes. If you have any further questions on the use of this product, ask your doctor or pharmacist.
",,"Other medicines and Gliclazide: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the follow ng medicines is taken:
+
+- other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists or insulin),
+- antibiotics (sulphonamides, clarithromycin)
+- medicines to treat high blood pressure or heart failure (beta-blockers. ACE-inhibitors such as captopril, or enalapril)
+- medicines to treat fungal infections (miconazole, fluconazole)
+- medicines to treat ulcers in the stomach or duodenum (H2 receptor antagonists),
+- medicines to treat depression (monoamine oxidase inhibitors)
+- painkiller or antirheumatics (phenylbutazone, ibuprofen)
+- medicines containing alcohol
+
+The blood-glucose-lowering effect of gliclazide may be weakened and raised blood sugar levels may occur when one of the following medicines is taken:
+
+- medicines to treat disorders of the central nervous system (chlorpromazine)
+- medicines reducing inflammation (corticosteroids)
+- medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline)
+- medicines to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol)
+- St John's Wort- Hypericum perforatum- preparations
+
+Blood glucose disturbance (low blood sugar and high blood sugar) can occur when a medicine belonging to a class of antibiotics called fluoroquinolones is taken at the same time as gliclazide especially in elderly patients.
Gliclazide may increase the effects of medicines that reduce blood clotting (warfarin).
Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking gliclazide.
Gliclazide with food and drink: Gliclazide can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.
Driving and using machines: Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too high (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (for instance when driving a car or using machines). Please ask your doctor whether you can drive a car if you:
+
+- have frequent episodes of low blood sugar (hypoglycaemia)
+- have few or no warning signals of low blood sugar (hypoglycaemia)
+
+Gliclazide contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
","Do not take Gliclazide:
+
+- if you are allergic to gliclazide or to other medicines of the same group (sulfonylurea), or to other related medicines (hypoglycaemic sulfonamides)
+- if you have insulin-dependent diabetes (type 1)
+- if you have ketone bodies and sugar in your urine (this may mean you have diabetic ketoacidosis), a diabetic pre-coma or coma
+- if you have severe kidney or liver disease
+- if you are taking medicines to treat fungal infections
+- if you are breastfeeding
+
","Like all medicines, Gliclazide can cause side effects, although not everybody gets them. The most commonly observed side effect is low blood sugar (hypoglycaemia). If left untreated these symptoms could progress to drowsiness, loss of consciousness or possibly coma. If an episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by eating sugar, you should seek immediate medical attention.
Liver disorders: There have been isolated reports of abnormal iiver function, which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.
Skin disorders: Skin reactions such as rash, redness, itching, hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. Rash may progress to widespread blistering or peeling of the skin. If you develop this, stop taking, seek urgent advice from a doctor and tell him that you are taking this medicine. Exceptionally, signs of severe hypersensitivity reactions have been reported: initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature.
Blood disorders: Decrease in the number of cells in the blood (e.g. platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever have been reported. These symptoms usually vanish when the treatment is discontinued.
Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are reduced when Gliclazide is taken with a meal as recommended.
Eye disorders: Your vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels.
As for another sulfonylurea, the following adverse events have been observed: cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (for instance jaundice) which in most cases disappeared after withdrawal of the sulfonylurea, but may lead to life-threatening liver failure in isolated cases.
Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.
","Gliclazide is not recommended for use during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You must not take Gliclazide while you are breastfeeding.
","Talk to your doctor before taking Gliclazide. You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, to observe the dietary regimen, have physical exercise and, where necessary, reduce weight During gliclazide treatment regular monitoring of your blood (and possibly urine) sugar level and also your glycated haemoglobin (HbA1c) is necessary. In the first few weeks of treatment, the risk of having reduced blood sugar levels (hypoglycaemia) may be increased. So particularly close medical monitoring is necessary.
Low blood sugar (Hypoglycaemia) may occur:
+
+- if you take meals irregularly or skip meals altogether,
+- if you are fasting
+- if you are malnourished
+- if you change your diet
+- if you increase your physical activity and carbohydrate intake does not match this increase,
+- if you drink alcohol, especially in combination with skipped meals,
+- if you take other medicines or natural remedies at the same time,
+- if you take too high doses of gliclazide,
+- if you suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, pituitary gland or adrenal cortex),
+- if your kidney function or liver function is severely decreased.
+
+if you have low blood sugar you may have the following symptoms: headache, intense hunger, nausea, vomiting, weariness, sleep disorders, restlessness, aggressiveness, poor concentration, reduced alertness and reaction time, depression, confusion, speech or visual disorders, tremor, sensory disturbances, dizziness and helplessness.
The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).
If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self-control, your breathing may be shallow and your heartbeat slowed down, you may become unconscious.
In most cases the symptoms of low blood sugar vanish very quickly when you consume .some form of sugar, (for instance, glucose tablets, sugar cubes, sweet juice, sweetened tea).
You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.
Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (for instance those acting on the central nervous system and beta-blockers).
If you are in stressful situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet sufficiently reduced the blood sugar when you have not complied with the treatment plan prescribed by your doctor if you take St. John’s Wort (Hypericum perforatum) preparations or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.
Blood glucose disturbances (low blood sugar and high bold sugar) can occur when Gliclazide is prescribed at the same time as medicines to a class of antibiotics called fluoroquinolone, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring your blood glucose.
If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking this medicinal product.
Gliclazide is not recommended for use in children due to lack of data.
",,,,,"Keep out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month. Store below 30°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
",10
+543,Hepatitis B Vaccine [rDNA],hepatitis-b-vaccine-rdna-543,https://medex.com.bd/attachments/xoZ1ZuVqvfTYrPrCeHZAWF4aq8u7SH/hepatitis-b-vaccine-rdna-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Active immunisation against hepatitis B,"Hepatitis B Vaccine is indicated for active immunization against infection caused by all known subtypes of Hepatitis B virus. As Hepatitis D (caused by the delta virus) does not occur in the absence of Hepatitis B infection, it can be expected that Hepatitis D will also be prevented by Hepatitis B vaccination ... Read more
Hepatitis B Vaccine is indicated for active immunization against infection caused by all known subtypes of Hepatitis B virus. As Hepatitis D (caused by the delta virus) does not occur in the absence of Hepatitis B infection, it can be expected that Hepatitis D will also be prevented by Hepatitis B vaccination.
Immunization is recommended in persons of all ages, especially those who are, or will be, at increased risk of exposure to Hepatitis B virus, for example:
A baby whose mother is infected can be infected at birth.
Children, adolescents, and adults can become infected by:
+
+- Contact with blood and body fluids through breaks in the skin such as bites, cuts, or sores
+- Contact with objects that have blood or body fluids on them such as toothbrushes, razors or monitoring and treatment devices for diabetes
+- Having unprotected sex with an infected person
+- Sharing needles when injecting drugs
+- Being stuck with a used needle
+- Household contacts of people infected with Hepatitis B
+- Residents and staff in institutions for the developmental^ disabled
+- Kidney dialysis patients
+- People who travel to countries where Hepatitis B is common
+- People with HIV infection
+- Persons with hemophilia, thalassemia, sickle cell anemia, cirrhosis
+
+Military personnel identified as being at increased risk.
Morticians and Embalmers.
Prisoners.
Users of illicit injectable drugs.
Others: Police, fire department personnel, who render first aid or medical assistance, and any others who, through their work or personal life-style, may be exposed to the Hepatitis B virus.
","Vaccines, Anti-sera & Immunoglobulin
",,"Neonates, infants and children upto 19 years of age: The recommended dose of Hepatitis B vaccine (rDNA) is >10 mcg of antigen protein in 0.5 ml.
Adults 19 years of age and older: The recommended dose of Hepatitis B vaccine (rDNA) is >20 mcg of antigen in 1 ml.
Primary immunization schedule for all ages:
The usual immunization schedule consists of 3 doses of vaccine-
+
+- First dose: at elected date
+- Second dose: 1 month after first dose
+- Third dose: 6 months after first dose
+
+or accelerated schedule consists of 4 doses of vaccine-
+
+- First dose: at elected date
+- Second dose: 1 month after first dose
+- Third dose: 2 months after first dose
+- Fourth dose: 12 months after first dose
+
+Accelerated schedule confer protection more quickly and is expected to provide better patient compliance.
Neonate born to hepatitis B surface antigen-positive mother, 4 doses of 10 micrograms:
+
+- First dose: at birth with Hepatitis B immunoglobulin injection (separate site)
+- Second dose: 1 month after first dose
+- Third dose: 2 months after first dose
+- Fourth dose: 12 months after first dose
+
+
For travellers departing within 1 month, adult over 18 years,
+
+- First dose: at elected date
+- Second dose: 7 days after first dose
+- Third dose: 21 days after first dose
+- Fourth dose: 12 months after first dose
+
+
Renal insufficiency (including haemodialysis patients), adult and child over 16 years 4 doses of 40 micrograms-
+
+- First dose: at the appropriate date
+- Second dose: 1 month after first dose
+- Third dose: 2 months after first dose
+- Fourth dose: 6 months after first dose
+
+Immunization schedule and booster doses may need to be adjusted in those with low antibody concentration.
Booster vaccinations: For persons with normal immune status who have been vaccinated, booster doses of
Hepatitis B vaccine has not been established. However, booster doses are recommended for hemodialysis patients or other immunocompromised persons.
","Method of administration: Hepatitis B Vaccine is for intramuscular injection only. Do not inject intravenously. Hepatitis B Vaccine should be given intramuscularly in the deltoid muscle of adult and children or in the anterolateral aspect of thigh in children under 1 year.
Preparation for administration: The vaccine should be shaken well before use to obtain a homogenous turbid white suspension. Do not shake vigorously. The vaccine should be inspected visually for particulate matter and discoloration prior to administration. If either of these conditions exists, the vaccine should not be administered. The vaccine should be used as supplied; no dilution is necessary
Co-administration: Hepatitis B vaccine can be given at the same time with other vaccine as Diphtheria, Tetanus, Pertussis (DTP), Polio (OPV), Measles, Mumps and Rubella (MMR), Haemophilus influenzae b, Hepatitis A and BCG vaccines at separate sites and with separate syringes. It should not be mixed with other vaccines or medicinal products in the same syringe.
",,"Hypersensitivity to any component of the vaccine, including yeast, is a contraindication. This vaccine is contraindicated in patients with previous hypersensitivity to any Hepatitis B virus containing vaccine.
","Hepatitis B vaccine is generally well tolerated. Most recipients of Hepatitis B vaccine experience some reactions upon vaccination. These are generally moderate and short. They mainly consist of local reactions at the injection site (erythema, induration and tenderness). Systemic reactions (malaise, headache, diarrhea, vomiting, myalgia and elevated temperature) are reported less commonly. In very rare cases allergic type reactions (pruritus, rash, urticaria) may be observed.
","The effect of Hepatitis B on fetal development or reproduction capacity has not been evaluated. However, it should only be used during pregnancy when there is a high risk of infection. Adequate human data on use during lactation and adequate animal reproduction studies are not available. It may be administered to nursing mothers only if clearly needed.
",,,,,,"Keep out of the reach and sight of children. Store at +2°C to +8°C. Transportation should also be at +2°C to +8°C. Protect from light. Do not freeze.
",8
+1430,Hepatitis b immune globulin,hepatitis-b-immune-globulin-1430,https://medex.com.bd/attachments/rp9L0strQGy51H30Mod98jfMXimOWy/hepatitis-b-immune-globulin-imm-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Sexual Exposure to an HBsAg-positive Person,"in order to prevent recurrence of hepatitis B virus infection after liver transplantation for liver failure caused by hepatitis B virus. In order to give rapidly available antibodies against hepatitis B virus to prevent hepatitis B in the following cases:
+
+- In case of accidental exposure in non-immunised subjects (that is persons who have not been vaccinated against the hepatitis B virus; including persons whose vaccination is incomplete or status unknown).
... Read more
in order to prevent recurrence of hepatitis B virus infection after liver transplantation for liver failure caused by hepatitis B virus. In order to give rapidly available antibodies against hepatitis B virus to prevent hepatitis B in the following cases:
+
+- In case of accidental exposure in non-immunised subjects (that is persons who have not been vaccinated against the hepatitis B virus; including persons whose vaccination is incomplete or status unknown).
+- In haemodialysed patients (that is patients with a severe renal failure that need a blood purification by an artificial kidney), until vaccination has become effective
+- In the newborn of a hepatitis B virus carrier-mother.
+- In subjects who did not show an immune response after vaccination (that is persons in which the vaccination did not become effective) and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B virus.
+
","Vaccines, Anti-sera & Immunoglobulin
",,"In order to prevent recurrence of hepatitis B virus infection after liver transplantation for liver failure caused by hepatitis B virus:
+
In adults: The suggested posology is 2000 IU IM every 15 days in the period after the transplantation, excluding the first week. This posology should be modified in the long-term treatment to ensure the maintenance of the serous level of HBsAg antibodies above 100 IU/l in HBV-DNA negative patients and above 500 IU/l in HBV-DNA positive patients.
The concomitant use of adequate virostatic agents should be considered, if appropriate, as a standard in hepatitis B reinfection prophylaxis.
Pediatric population: There is no relevant use of UMAN BIG in the pediatric population in the indication prevention of hepatitis B virus recurrence after liver transplantation for hepatitis B induced liver failure.
+In order to prevent hepatitis B:
+Prevention of hepatitis B in case of accidental exposure in non-immunised subjects: at least 500 IU (International Units), depending on the intensity of exposure, as soon as possible after exposure, and preferably within 24 - 72 hours.
+Immunoprophylaxis of hepatitis B in haemodialysed patients:
+8-12 IU/kg with a maximum of 500 IU, every 2 months until the vaccination has become effective Prevention of hepatitis B in the newborn, of a hepatitis B virus carrier-mother, at birth or as soon as possible after birth: 30-100 IU/kg. The hepatitis B immunoglobulin administration may need to be repeated until the vaccination has become effective.
In all these situations, vaccination against hepatitis B virus is highly recommended. The first vaccine dose can be injected the same day as human hepatitis B immunoglobulin, however in different sites.
If you have not shown an immune response after vaccination (no measurable hepatitis B antibodies), and in case a continuous prevention is necessary, the doctor may consider the administration of 500 IU (to adults) and 8 IU/kg (to children) every 2 months.","Hepatitis b immune globulin should be administered by intramuscular route. The product should be brought to room or body temperature before use. Remove the central protection from the rubber stopper and draw the solution with an injection syringe. Change the needle and inject. Once the solution is withdrawn from the container into the syringe, the medicinal product must be administered immediately. The liquid preparation is clear and colorless or pale-yellow or light brown. Do not use solutions that are cloudy or have deposits.
If a large volume (>2 ml for children or >5 ml for adults) is required, it is recommended to administer this in divided doses at different sites. Any unused product or waste material should be disposed of in accordance with local requirements.
","Hepatitis b immune globulin must not be mixed with other medicinal products.
","If you are allergic (hypersensitive) to human immunoglobulins or to any of the other ingredients of Hepatitis b immune globulin. For example, if you have a deficiency of immunoglobulin A (IgA), you may develop, in the blood, antibodies against the immunoglobulin A. Hepatitis b immune globulin contains small quantity of IgA and therefore severe allergic reactions could occur. The physician must therefore weigh the benefit of treatment with Hepatitis b immune globulin against the potential risk of allergic reactions.
","Hypersensitivity, Anaphylactic shock, Headache, Tachycardia, Hypotension, Vomiting, Erythema, Itching, Malaise
","Pregnancy: The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the fetus and the neonate are to be expected.
Breastfeeding: Immunoglobulins are excreted into the milk and may contribute to the transfer of protective antibodies to the neonate.
Fertility: Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.
Driving and using machines: No effects on ability to drive and use machines have been observed
","Who administers Hepatitis b immune globulin to you should ensure that the product is not administered into a blood vessel, this could cause an acute (o severe) crisis of the circulatory system, known as shock?
If you are a carrier of HBsAg, there is no benefit in administering this product. Serious allergic reactions are rare.
Rarely, the human anti-hepatitis B immunoglobulins can induce a sudden fall in blood pressure with disorder of breathing, faints, sometimes fever and skin reactions (anaphylactic reaction). This can happen even if you have tolerated previous treatments with immunoglobulins.
If your doctor or who administers to you the product should suspect an allergic or anaphilactic reaction must stop immediately the administration. In case of shock, your doctor should follow the standard medical treatment for shock.
The product contains 3.9 mg sodium per ml. This must be taken into consideration, depending on the total amount of product that you must assume, if you are on a low salt diet.
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include:
+
+- A careful selection of blood and plasma donors to make sure that those at risk of carrying infections are excluded;
+- The testing of the donations to ensure that there are no infective agents and/or viruses;
+- The inclusion, during manufacturing process of steps capable of inactivating or removing viruses.
+
+Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging infectious agents or other types of infections.
The measures taken are considered effective for viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and for hepatitis A virus (HAV).
The measures taken may be of limited value against viruses such as parvovirus B19. Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective.
It is strongly recommended that every time you receive a dose of Hepatitis b immune globulin the name and batch number of the product are recorded in order to maintain a record of the batches used.
",,"Consequences of an overdose are not known
",,,"Store in a refrigerator (2-8°C). Keep in the outer carton in order to protect from light. Keep out of the reach and sight of children
",11
+542,Hepatitis A Vaccine,hepatitis-a-vaccine-542,https://medex.com.bd/attachments/e51Tm71bJafDm2vS3YpQD0dTg6SeMA/hepatitis-a-vaccine-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Hepatitis A virus,"Hepatitis A Vaccine is indicated for active immunization against disease caused by hepatitis A virus (HAV). Hepatitis A Vaccine is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV.
","Vaccines, Anti-sera & Immunoglobulin
","The hepatitis A virus belongs to the picornavirus family. It is one of several hepatitis viruses that cause systemic disease with pathology in the liver. The incubation period for hepatitis A averages 28 days (range: 15 to 50 days). The course of hepatitis A infection is extremely variable, ranging from asymptomatic infection to icteric hepatitis and death. The presence of antibodies to HAV confers protection against hepatitis A infection. However, the lowest titer needed to confer protection has not been determined.
","Children and Adolescents: Primary immunization for children and adolescents (12 months through 18 years of age) consists of a single 0.5 mL dose and a 0.5 mL booster dose administered anytime between 6 and 12 months later. The preferred sites for intramuscular injections are the anterolateral aspect of the thigh in young children or the deltoid muscle of the upper arm in older children.
Adults: Primary immunization for adults consists of a single 1 mL dose and a 1 mL booster dose administered anytime between 6 and 12 months later. In adults, the injection should be given in the deltoid region.
","Preparation For Administration: Shake well before use. With thorough agitation, Hepatitis A Vaccine is a homogeneous, turbid, white suspension. Do not administer if it appears otherwise. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.
For the prefilled syringes, attach a sterile needle and administer intramuscularly.
For the vials, use a sterile needle and sterile syringe to withdraw the vaccine dose and administer intramuscularly. Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. Use a separate sterile needle and syringe for each individual.
Hepatitis A Vaccine should be administered by intramuscular injection only. Hepatitis A Vaccine should not be administered in the gluteal region; such injections may result in suboptimal response. Do not administer this product intravenously, intradermally, or subcutaneously.
","Reduced response to vaccination when used concurrently with immunosuppressants such as corticosteroids or antineoplastics.
","Hypersensitivity. Vaccines prepared in egg cultures are contraindicated in patients with hypersensitivity reactions to egg. Severe immunodeficiency. Malignant disease being treated with chemotherapy or radiotherapy and for at least 6 mth after stopping treatment. Patients with compromised immune system such as those on high-dose systemic corticosteroids, immunosuppressants or HIV positive.
","Transient soreness, erythema, induration at inj site. Fever, malaise,
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Nursing Mothers: It is not known whether Hepatitis A Vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Hepatitis A Vaccine is administered to a nursing woman.
","Alcohol or disinfectant used for cleaning the skin prior to inj should be allowed to evaporate completely before vaccination to prevent vaccine inactivation.
","Pediatric Use: The safety and effectiveness of Hepatitis A Vaccine, doses of 360 EL.U. or 720 EL.U., have been evaluated in more than 22,000 subjects 1 year to 18 years of age. The safety and effectiveness of Hepatitis A Vaccine have not been established in subjects younger than 12 months of age.
Geriatric Use: Clinical studies of Hepatitis A Vaccine did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in overall safety between these subjects and younger adult subjects.
Hepatic Impairment: Subjects with chronic liver disease had a lower antibody response to Hepatitis A Vaccine than healthy subjects
",,,,"Store refrigerated between 2° to 8° C . Do not freeze. Discard if the vaccine has been frozen. Do not dilute to administer.
",12
+566,Heparin Sodium,heparin-sodium-566,https://medex.com.bd/attachments/b1uy8QNnHOBQ2LFBTazYJPBLmggFS9/heparin-sodium-prescribing-information,Parenteral anti-coagulants,Unstable angina,"Heparin sodium is indicated for:
Atrial fibrillation with embolization:
+
+- Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation);
+- Prevention of clotting in arterial and heart surgery;
+- Anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension;
... Read more
Heparin sodium is indicated for:
Atrial fibrillation with embolization:
+
+- Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation);
+- Prevention of clotting in arterial and heart surgery;
+- Anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension;
+- (In a low-dose regimen) for prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdomino-thoracic surgery or who for other reasons are at risk of developing thromboembolic disease
+- Prophylaxis and treatment of pulmonary embolism;
+- Prophylaxis and treatment of peripheral arterial embolism.
+
","Parenteral anti-coagulants
","Heparin inhibits reactions that lead to the clotting of blood and the formation of fibrin clots both in vitro and in vivo. Heparin acts at multiple sites in the normal coagulation system. Small amounts of heparin in combination with antithrombin III (heparin cofactor) can inhibit thrombosis by inactivating activated Factor X and inhibiting the conversion of prothrombin to thrombin. Once active thrombosis has developed, larger amounts of heparin can inhibit further coagulation by inactivating thrombin and preventing the conversion of fibrinogen to fibrin. Heparin also prevents the formation of a stable fibrin clot in inhibiting the activation of the fibrin stabilizing factor.
Bleeding time is usually unaffected by heparin. Clotting time is prolonged by full therapeutic doses of heparin; in most cases, it is not measurably affected by low doses of heparin.
","Intravenous-Prophylaxis of re-occlusion of the coronary arteries following thrombolytic therapy in myocardial infarction
+
+- Adult: 60 U/kg (max: 4,000 U) or a bolus of 5,000 U if streptokinase was used, followed by 12 U/kg/hr (max: 1,000 U/hr) w/ a treatment duration of 48 hr.
+
+
Intravenous-Peripheral arterial embolism, Unstable angina, Venous thromboembolism
+
+- Adult: 75-80 U/kg or 5,000 U (10,000 U in severe pulmonary embolism) IV loading dose followed by 18 U/kg or 1,000-2,000 U/hr continuous infusion. Alternatively, intermittent inj of 5,000-10,000 U 4-6 hrly.
+- Child: 50 U/kg loading dose, followed by an infusion of 15-25 U/kg/hr.
+- Elderly: Lower dosages may be required.
+
+
Subcutaneous-Prophylaxis of postoperative venous thromboembolism
+
+- Adult: 5,000 U given 2 hr before surgery then 8-12 hrly for 7 days or until the patient is ambulant.
+
+
Subcutaneous-Venous thromboembolism
+
+- Adult: 15,000-20,000 U 12 hrly or 8,000-10,000 U 8 hrly.
+- Child: 250 U/kg bid.
+- Elderly: Lower dosages may be required.
+
",,"Enhanced anticoagulant effect with other drugs affecting platelet function or the coagulation system (e.g. platelet aggregation inhibitors, thrombolytic agents, salicylates, NSAIDs, vit K antagonists, dextrans, activated protein C). Decreased anticoagulant effect with gyceryl trinitrate infusion. Increased risk of hyperkalaemia with ACE inhibitors or angiotensin II antagonists.
","Current or history of heparin-induced thrombocytopenia; generalised or local haemorrhagic tendency, including uncontrolled severe HTN, severe liver insufficiency, active peptic ulcer, acute or subacute septic endocarditis, intracranial haemorrhage or injuries and operations on the CNS, eyes and ears, and in women with abortus imminens; epidural anaesth during birth; locoregional anaesth in elective surgical procedures (in patients receiving heparin for treatment rather than prophylaxis).
","Hypersensitivity reactions (e.g. chills, fever, urticaria, asthma, rhinitis); painful, ischaemic and cyanosed limbs; osteoporosis (in long-term admin), suppression of aldosterone synthesis leading to hyperkalaemia, cutaneous necrosis, delayed transient alopecia, priapism, rebound hyperlipaemia; increased serum concentrations of AST and ALT, prolonged prothrombin time; local irritation, erythema, mild pain, haematoma or ulceration on inj site.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Nursing Mothers: Due to its large molecular weight, heparin is not likely to be excreted in human milk, and any heparin in milk would not be orally absorbed by a nursing infant. Benzyl alcohol present in maternal serum is likely to cross into human milk and may be orally absorbed by a nursing infant. Exercise caution when administering Heparin Sodium Injection to a nursing mother.
","Patient with increased risk of bleeding complications, HTN, DM, pre-existing metabolic acidosis. Do not use in catheter lock flushing. Hepatic and renal impairment. Elderly. Pregnancy and lactation.
","Pediatric Use: There are no adequate and well controlled studies on heparin use in pediatric patients. Pediatric dosing recommendations are based on clinical experience. Carefully examine all Heparin Sodium Injection vials to confirm choice of the correct strength prior to administration of the drug. Pediatric patients, including neonates, have died as a result of medication errors in which vials have been confused with “catheter lock flush” vials
","Symptoms: Bleeding (nose bleeds, blood in urine or tarry stools may be noted as the 1st sign of bleeding).
Management: May give protamine sulfate by slow IV infusion over 10 min to treat severe bleeding (1 mg of protamine sulfate neutralises approx 100 U of heparin). Max: 50 mg as a single dose.
",,,"Store between 20-25° C. Protect from freezing.
",12
+181,Hartmann's Solution,hartmanns-solution-181,https://medex.com.bd/attachments/BSJveNCD2ogGxSfqCqbA8Af9JzY024/hartmanns-solution-prescribing-information,Haemodialysis solutions,Vomiting,"This is used to treat hypovolemia caused by surgery, hemorrhage and trauma. Excessive sweating, severe diarrhoea or vomiting, excess loss of fluid by nephritic kidneys, inadequate intake of fluid and electrolytes etc. that may lead to typical hypovolemic shock may be corrected with this solution ... Read more
This is used to treat hypovolemia caused by surgery, hemorrhage and trauma. Excessive sweating, severe diarrhoea or vomiting, excess loss of fluid by nephritic kidneys, inadequate intake of fluid and electrolytes etc. that may lead to typical hypovolemic shock may be corrected with this solution . Severe plasma loss caused by intestinal obstruction, burns or other denuding conditions of the skin may be treated with this solution. It is mainly used as a fluid and electrolyte replenisher. It may be used as an alternative to Sodium Bicarbonate in the treatment of metabolic acidosis associated with dehydration and to alkalinized urine.
","Haemodialysis solutions
",,"The volume and rate of infusion will depend upon the requirements of the patients and the judgement of the physician. It usually varies with age, weight and clinical condition of the patient. The recommended flow rate is up to 100-drops/minute/70 kg body weight. In burn patients the dose of Hartmann's solution according to the Parkland formula: 4 ml/kg body weight% of Body surface area (BSA) burn (e.g. for a 30% BSA burn of a person having 60 kg body weight, 4 x 60 x 30 ml = 7200 ml of Hartmann's solution would be required in 24 hours). Half of this within 8 hr, the remainder over 16 hr.
","
+- Check infusion set and infusion solution prior to use
+- Pull moderately to tear off the protective cover of the Eurohead
+- Hold lightly the Eurohead but not the bag
+- Open the flow regulator fully and hold the giving set on the top white area, but not the membrane venting region
+- Insert the spike of the administration set to the Eurohead and fit the connector of the administration set firmly to the needle
+- Gradually allow the fluid to flow down to the needle tip and close
+- Remove the protective cover of the needle
+- Locate the veinpuncture site and clean the site with an antiseptic solution, and then insert the needle
+- Securely tape the puncture site
+- Securely tape the wings and tubing
+- Start infusion while adjusting drip speed
+
",,"Do not take this medicine and tell your doctor if: Hartmann's solution may be relatively contraindicated in patients with diabetes mellitus, as one of the isomers of lactate is gluconeogenic.
","Hands, ankles and feet may become mildly swollen from fluid retention. Rarely, the lungs can also be affected, which may cause breathing difficulty. Other possible symptoms include nausea, vomiting, headache, dizziness, drowsiness, confusion, and inflammation or swelling of the veins around the site of the injection.
","Pregnancy Category C. Animal reproduction studies have not been conducted with Lactated Ringer’s Irrigation. It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.
","Hartmann's solution should not be administered rapidly or for prolonged periods. Since the solution contains different electrolytes, it should be infused with caution in patients where electrolyte imbalance may cause detrimental effects; e.g. in pregnancy, renal impairment, heart failure, pulmonary congestion, etc. or to patients receiving potassium sparing diuretics. In Pregnancy: Pregnancy Category C. Infusion of fluid should be immediately discontinued if rigor arises for any reason during the process. Do not use if the solution is cloudy, contains particles, or after expiry date. Infusion of fluid should be immediately discontinued if rigor arises for any reason during the process. Do not use if the solution is cloudy, contains particles, or after expiry date.
",,,,,"Electrosal should be stored at controlled room temperature.
",9
+541,Halothane,halothane-541,,General (Inhalation) anesthetics,General anaesthesia,"Halothane is a volatile anaesthetic which is suitable for the induction and maintenance of anaesthesia for all types of surgery and in patients of all ages.
","General (Inhalation) anesthetics
","When inhaled, Halothane is absorbed through the alveoli into the bloodstream. In the bloodstream, Halothane circulates through the body to the principal site of action, the brain. Here Halothane causes a progressive depression of the central nervous system, beginning with the higher centers (cerebral cortex) and spreading to the vital centers in the medulla. This depression is reversible. However, its mode of action, like all anaesthetic agents, is unknown.
Halothane has a relatively low solubility in blood and therefore alveoli/blood concentrations equilibrate rapidly. The triexponential decline in Halothane blood concentrations following the end of administration is thought to represent distribution into three compartments; the vessel rich group (brain/heart/liver), the musculature and adipose tissue. Approximately 80% of the inhaled Halothane is eliminated unchanged by the lungs. The remaining 20% is metabolized in the liver by oxidative and under hypoxic conditions, reductive pathways. The main metabolites are trifluoroacetic acid, bromide and chloride salts (via the oxidative pathway) and fluoride salts (via the reductive pathway). The concentrations of metabolites peak 24 hours post-operatively and are eliminated by renal excretion during the following week.
","A number of anaesthetic vaporisers specially designed for use with Halothane are available. Open, semi-open, semi-closed and closed circuit systems have all been used with good results.
For induction of anaesthesia:
+
+- Adult: A concentration of 2-4% Halothane in Oxygen or Nitrous Oxide may be used.
+- Children: A concentration of 1.5-2% Halothane in Oxygen or Nitrous Oxide is used.
+
+For maintenance of anaesthesia:
+
+- Adults and children: A concentration of 0.5-2% is usually required for maintenance of anaesthesia. The lower concentration is usually most suitable for elderly patients.
+
",,"Increased risk of ventricular dysrhythmias with epinephrine. Increased risk of malignant hyperthermia with suxamethonium. Prolonged recovery from anaesth with concurrent use of ketamine for induction. May potentiate response to non-depolarising muscle relaxants, hypotensive agents (e.g. hexamethonium bromide, trimetaphan camsilate).
","Halothane can induce liver damage; however, the incidence of severe liver damage (jaundice, which may lead to hepatic failure as a consequence of massive hepatic cell necrosis) is unknown. The risk of developing hepatic failure appears to be increased by repeated exposure. Although short intervals of time between exposures are likely to increase the risk of hepatotoxicity, even long intervals between exposures may
not eliminate the risks, since some patients have developed severe reactions following Halothane given many years after the previous exposures. On the information which is available at the present time, it is advised that the following
precautions be taken
+
+- A careful anaesthetic history should be taken prior to use, to determine previous exposure and previous reactions following Halothane anaesthesia.
+- Repeated exposure to Halothane within a period of at least 3 months should be avoided unless there are overriding clinical circumstances.
+- History of unexplained jaundice and pyrexia in a patient following exposure to
+- Halothane is a contraindication to its future use in that patient unless absolutely essential.
+- Patients should be informed if they have developed a reaction possibly related to Halothane anaesthesia; such patients should be provided with a medical alert card stating the problem.
+
","Post-op nausea, vomiting, and shivering; resp depression, hypotension, skeletal muscle relaxation, bradycardia.
","Category C: Although the data from experimental investigations in animals cannot be directly related to man, it would be prudent to avoid general anaesthesia with inhalation agents during early pregnancy, except where such use is essential.
Lactation: There are no well controlled studies with Halothane in lactating women. Halothane has been detected in breast milk of lactating women, but the effect of Halothane on breast feed neonates has not been established. However, Halothane has been in wide use for over 30 years without apparent ill consequence
","Caution should be exercised during administration of adrenaline to patients anaesthetised with Halothane as dysrhythmias may be precipitated. For this reason the dose of adrenaline should be restricted and beta-receptor antagonists administered if necessary. Ensure adequate room ventilation when Halothane is being used. Keep the concentration of Halothane in air as low as possible.
Effect on ability to drive or operate machinery: Patients should be advised that performance at skilled tasks, such as driving and operating machinery, may be impaired for some time after general anaesthesia.
Accidental ingestion: Cases of ingestion must be treated symptomatically.
",,,,,"Bottles of Halothane must be securely closed and stored in a cool dry place, protected from light. Halothane must be kept in the original container until immediately prior to its use.
Whilst in the liquid phase, Halothane must not be diluted or contaminated; however, in the vapour phase it may be administered together with Oxygen or a mixture of Nitrous Oxide and Oxygen.
",10
+540,Haloperidol,haloperidol-540,https://medex.com.bd/attachments/dIqEYUCSOQ7ZRZ9nsMJaeVbJ4kfZh5/haloperidol-injection-prescribing-information,"Drugs used in tremor, tics & related disorder",Unipolar and bipolar depression,"In low doses-
+
+- nervousness, anxiety states and associated psychic disorders as irritability gressiveness, psychic lability and insomnia
+- functional disorders caused by anxiety states such as trembling, thorax oppression, gastrointestinal hypermotility and digestive disorders
+- tics and stuttering
... Read more
In low doses-
+
+- nervousness, anxiety states and associated psychic disorders as irritability gressiveness, psychic lability and insomnia
+- functional disorders caused by anxiety states such as trembling, thorax oppression, gastrointestinal hypermotility and digestive disorders
+- tics and stuttering
+- nausea and vomiting
+
+In higher doses-
+
+- psychomotor agitation in mania, dementia, acute and chronic schizophrenia, alcoholism
+- delusions and hallucinations in acute and chronic schizophrenia, acute confusion
+- choreatic movements
+- behavior and character disorders in children
+- tics and stuttering
+- vomiting
+
","Butyrophenone drugs, Drugs used in tremor, tics & related disorder
","Haloperidol is a butyropherone derivative with antipsychotic properties that has been considered particularly effective in the management of hyperactivity, agitation and mania. Haloperidol is an effective neuroleptic and also possesses antiemetic properties. It may also exhibit hypothermic and anorexiant effects and potentiate the action of barbiturates, general anesthetics and other CNS depressant drugs. Haloperidol is a quick acting substance and has a duration of action of about 12 hours after one single administration. The optimum daily therapy consists of 2 administrations.
","Tablet-
Initial dose for adults-
+
+- Moderate symptomatology: 0.5 mg to 3.0 mg 2 to 3 times daily
+- Severe symptomatology: 3.0 mg to 5.0 mg 2 to 3 times daily
+- Elderly patients: 0.5 mg to 4.5 mg 2 to 3 times daily
+- Chronic or Resistant patients: 3.0 mg to 6.0 mg 2 to 3 times daily
+
+Patients who remain severely disturbed or inadequately controlled may require dose adjustment. Daily dose upto 100 mg may be necessary in some cases to achieve optimal response.
Children: A suggested dose for the management of behaviour disorders in disturbed and schizophrenic children is 50 microgram per kg body weight.
Injection (intramuscular or intravenous)-
Schizophrenia and other psychosis, mania:
+
+- Initially 2-10 mg, then every 4-8 hours according to response to total maximum 18 mg daily
+- Severely disturbed patients may require an initial dose of up to 18 mg
+- Elderly (or debilitated) initially half adult dose
+- For children not recommended.
+
",,"Haloperidol has been reported to interfere with the anticoagulant properties of phenindione in an isolated case and the possibility should be kept in mind of a similar effect occurring when haloperidol is used with other anticoagulants. Haloperidol may antagonize the action of epinephrine and other sympathomimetic agents and reverse the blood pressure lowering effects of adrenergic-blocking agents, such as guanethidine. Enhanced CNS effects may occur when haloperidol is used in combination with methyldopa. Haloperidol inhibits the metabolization of tricyclic antidepressants, thereby increasing plasma levels of these drugs. This may result in increased tricyclic antidepressant toxicity (anticholinergic effects, cardiovascular toxicity, lowering of seizure threshold). Haloperidol may impair the antiparkinson effects of levodopa. If an antiparkinson agent is used concomitantly with haloperidol, both drugs should not be discontinued simultaneously, since extrapyramidal symptoms may occur due to the slower excretion rate of haloperidol.
","Comatose states and CNS depression due to alcohol or other depressant drugs; severe depressive states; previous spastic diseases; lesions of the basal ganglia; Parkinson's syndrome, except in the case of dyskinesias due to levodopa treatment; sensitivity to haloperidol; senile patients with pre-existing Parkinson-like symptoms.
","Haloperidol is a safe neuroleptic. Headache, vertigo, insomnia are the more common side effects encountered. Drowsiness, lethargy, stupor, confusion, restlessness, agitation, anxiety, euphoria and exacerbation of psychotic symptoms including hallucinations also may occur. Dry mouth, blurred vision, urinary retention, heartburn, nausea, vomiting, anorexia, diarrhea and hypersalivation have also been reported.
","Safety for use in pregnancy and lactation has not been established; do not administer to women of childbearing potential or nursing mothers unless, in the opinion of the physician, the expected benefits of the drug outweigh the potential hazard to the fetus or child. Haloperidol is excreted in breast milk.
","Haloperidol may lower the convulsive threshold and has been reported to trigger seizures in previously controlled known epileptics. When instituting haloperidol therapy in these patients, adequate anticonvulsant medication should be maintained concomitantly. As with other antipsychotic agents, haloperidol should be administered cautiously to patients with severe impairment of liver or kidney function and to patients with known allergies or history of allergies to other neuroleptic drugs. Caution is also advised in patients with pheochromocytoma and conditions predisposing to epilepsy such as alcohol withdrawal and brain damage. Since the drug may have a possible potentiating effect on potent analgesics or hypnotics, caution is recommended when prescribing it to patients who are regularly treated with such drugs.
",,"In general, the symptoms of overdosage would be an exaggeration of known pharmacologic effects and adverse reactions, the most prominent of which would be: severe extrapyramidal reactions, hypotension or sedation.The patient would appear comatose with respiratory depression and hypotension which could be severe enough to produce a shock-like state.
",,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",11
+1639,Halobetasol Propionate + Tazarotene,halobetasol-propionate-tazarotene-1639,https://medex.com.bd/attachments/2qvTSW4JqMFmFearJeoHyu6KVuK3kp/halobetasol-propionate-tazarotene-prescribing-information,Other Topical corticosteroids,Plaque psoriasis,"This Lotion is a combination of halobetasol propionate and tazarotene indicated for the topical treatment of plaque psoriasis in adults.
","Other Topical corticosteroids
","Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in plaque psoriasis is unknown. Tazarotene is a retinoid prodrug which is convert d to its active form, tazarotenic acid, the carboxylic acid of tazarotene, by deesterification. Tazarotenic acid binds to all three members of the retinoic acid receptor (RAR) family: RARα, RARβ and RARγ, but shows relative selectivity for RARβ, and RARγ and may modify gene expression. The clinical significance of these findings for the treatment of plaque psoriasis is unknown.
A vasoconstrictor assay in healthy subjects with this lotion indicated that it is in the high to super-high range of potency as compared to other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence. The potential for hypothalamic-pituitary-adrenal (HPA) axis suppression was evaluated in a study in adult subjects with moderate to severe plaque psoriasis. A median dose of 8.2 grams this lotion was applied once daily for 8 weeks and 20 subjects were assessed for HPA axis suppression at Weeks 4 and 8. HPA axis suppression was observed in 3 out of 20 (15%) subjects at Week 4. None of the 20 (0%) subjects had HPA axis suppression at Week 8. In this study, the criteria for HPA axis suppression was a serum cortisol level of less than or equal to 18 micrograms per deciliter 30 minutes after stimulation with cosyntropin (adrenocorticotropic hormone).
","Apply a thin layer of this lotion once daily to cover only affected areas and rub in gently. If a bath or shower is taken prior to application, the skin should be dry before applying the lotion. The total dosage should not exceed approximately 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Do not use with occlusive dressings unless directed by a physician. Discontinue treatment when control is achieved. Avoid the application of this lotion on the face, groin, or in the axillae. This lotion is not for oral, ophthalmic, or intravaginal use.
",,,"This lotion is contraindicated in pregnancy.
","The most common side effects are redness, itching, swelling, burning, stinging, application site pain, inflamed hair follicles (folliculitis), thinning of the skin (atrophy), peeling and rash.
","Based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, This Lotion may cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy. Safety in pregnant females has not been established. There are no data on the presence of tazarotene, halobetasol propionate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production after treatment with This Lotion.
","
+- This lotion contains tazarotene, which is a teratogenic substance. In females of reproductive potential, obtain a negative pregnancy test within 2 weeks prior to initiating treatment and advise patients to use an effective method of contraception during treatment.
+- Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency during or after treatment.
+- Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria.
+- Systemic absorption may require evaluation for HPA axis suppression.
+- Use of potent corticosteroids on large areas, for prolonged durations, under occlusive dressings, or on an altered skin barrier may increase systemic exposure.
+- Local Adverse Reactions: Local adverse reactions may include atrophy, striae, telangiectasias, and folliculitis. If these effects occur, discontinue at least until the integrity of the skin has been restored. DUOBRII Lotion should not be used on eczematous skin, as it may cause severe irritation.
+- Photosensitivity and Risk for Sunburn: Avoid exposure to sunlight, sunlamps, and weather extremes. DUOBRII Lotion should be administered with caution if the patient is also taking drugs known to be photosensitizers.
+- Ophthalmic Adverse Reactions: Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist
+
","Safety and effectiveness of this lotion in pediatric patients under the age of 18 years have not been evaluated.
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+538,Halobetasol Propionate,halobetasol-propionate-538,https://medex.com.bd/attachments/Gxsq5R4nTZTcINnSDdBmCdLL7po20Q/halobetasol-propionate-prescribing-information,Other Topical corticosteroids,Psoriasis,"Halobetasol Propionate 0.05% is a super-high potent corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 gm/week because of the potential for the drug to suppress the Hypothalamic-Pituitary-Adrenal (HPA) axis.
","Other Topical corticosteroids
","Like other topical corticosteroids, halobetasol propionate has anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of the anti-inflammatory activity of the topical corticosteroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2 .
","Apply a thin layer of Halobetasol Cream or Ointment to the affected skin once or twice daily, as directed by the physician, and rub in gently and completely. Halobetasol 0.05% is a super-high potency corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 gm/week should not be used. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Halobetasol should not be used with occlusive dressings.
",,,"Halobetasol Propionate Cream/Ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
","The following adverse effects have been reported infrequently with topical corticosteroids. These reactions include burning, itching, dryness, folliculitis acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin atrophy, secondary infections, striae and miliaria.
","Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Therefore caution should be exercised when topical corticosteroids are administered to a nursing woman.
","Systemic absorption of topical corticosteroids may cause reversible Hypothalamic-Pituitary-Adrenal (HPA) axis suppression, manifestations of cushing's syndrome, hyperglycemia, and glucosuria. Patients receiving large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.
","Use in children under 12 years of age is not recommended. Safety and effectiveness of Halobetasol Propionate cream & ointment in paediatric patients have not been established. Paediatric patients are at greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids.
",,,,"Store below 30°C. Keep all medicines out of reach of children.
",10
+537,Halcinonide,halcinonide-537,https://medex.com.bd/attachments/IBwVePzmM4KV9VTtClB3TyyTo0fbxZ/halcinonide-prescribing-information,Other Topical corticosteroids,Skin infections,"Halcinonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
","Other Topical corticosteroids
","The precise mechanism of action of topical corticosteroids is unclear. However they possess anti-inflammatory, antipruritic, and vasoconstrictive actions. New research indicates that halcinonide activates MBP (myelin basic protein) expression via smoothened receptor activation. This finding suggests that halcinonide could be used in the treatment of multiple sclerosis therapy as an alternative to Dexamethasone or Methylprednisolone.
","Apply the 0.1% Halcinonide Cream to the affected area two to three times daily. Rub in gently.
",,,"Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations, Primary infectious (viral, fungal, bacterial) ulcers, acne vulgaris.
","Prolonged application causes epidermal thinning, contact dermatitis, perioral dermatitis, papular disorder, mild depigmentation; telangiectasia, striae (especially face and flexures). Application on eyelids and surrounding skin can raise intraocular pressure, cataracts, glaucoma, corneal ulcers and raised intracranial pressure. Systemic absorption with adrenal suppression may be seen when applied to large areas, when skin is broken or under occlusive dressing.
","Pregnancy Category C. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.
","Neonates, childn, elderly, hepatic failure. Not to be applied over large areas under occlusive dressings. Caution when applied to areas of broken skin. Pregnancy, lactation.
","Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.
HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
Geriatric Use: Of approximately 3000 patients included in clinical studies of 0.1% Halcinonide cream , 14% were 60 years or older, while 4% were 70 years or older. No overall differences in safety were observed between these patients and younger patients. Efficacy data have not been evaluated for differences between elderly and younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
","Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects
",,,"Should be stored in cool and dry place
",11
+560,Halazone,halazone-560,,Water purifying agent,Water disinfection,"Tablets for solution 4 mg, are used for making water free form Bacteria and Germs responsible for water borne diseases. The mass of each tablet is 100 mg which releases 2 mg of chlorine sufficient to chlorinate 1 liter of water. Dissolve one tablet in one litre of water to be treated and allow 30 minutes time to react. Water will then be ready for potable purposes.
","Water purifying agent
","Halazone's disinfecting activity is mainly due to the hypochlorous acid (HClO) released by hydrolysis of the chlorine-nitrogen bonds when the product is dissolved in water: (R1)(R2)NCl+H2O → HOCl+(R1)(R2)NH
The hypochlorous acid is a powerful oxidizer and chlorinating agent that destroys or denatures many organic compounds.
Halazone Tablets have a prominent status among water purification tablets for ensuring hygienic quality of water with its effective bactericidal activity in water. Halazone Tablets are a powerful purifier of drinking water in small quantities.
","4 mg: To treat 1 liter water.
20 mg: To treat 5 liter water
40 mg: To treat 10 liters water.
80 mg: To treat 20 liters water.
100 mg: To treat 25 liters water.
200 mg: To treat 50 liters water.
400 mg: To treat 100 liters water.
",,,,,,,,,,,"Should be stored in cool and dry place.
",5
+559,Haemophilus Influenzae Type B Vaccine [Conjugated],haemophilus-influenzae-type-b-vaccine-conjugated-559,https://medex.com.bd/attachments/MpSfGE5Hm6GCTE4cVnZI8G75BlKLm9/haemophilus-influenzae-type-b-vaccine-conjugated-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Septicemia,"Active immunisation against invasive disease caused by Haemophilus influenzae type b in children from 2 months of age. This vaccine does not stimulate protection against diseases caused by different Haemophilus Influenzae serotypes and from other meningitis types caused by different pathogen agents.
","Vaccines, Anti-sera & Immunoglobulin
","Haemophilus influenzae type b (Hib) bacteria are surrounded by polysaccharide capsules, which make the bacteria resistant to attack by white blood cells. However, human blood serum contains antibodies, which render the bacteria vulnerable to attack. The vaccine, which is composed of the purified polysaccharide from Hib bacterial cells, stimulates production of anticapsular antibodies and provides active immunity to the Haemophilus influenzae type b bacteria represented by the polysaccharide in the vaccine.
Haemophilus b polysaccharide vaccine, unlike the conjugate vaccine, predominantly stimulates B-cells to produce antibodies. This is known as being T-cell independent and is characteristic of polysaccharide vaccines. The initial stimulation of T-cells followed by stimulation of B cells (known as a T-cell response) is particularly important in young children to ensure adequate and persisting antibody production. Stimulation of T-cells also results in an anamnestic response to future doses of the vaccine and future natural exposure to Haemophilus influenzae type b. The poor T-cell response stimulated by the polysaccharide vaccine is thought to be one reason why the polysaccharide vaccine is not adequately immunogenic in children up to 18 months of age and may not be fully immunogenic in children 18 to 24 months of age. In addition, lack of initial T-cell stimulation probably is the reason that repeat doses of the polysaccharide vaccine do not boost the antibody response consistently.
","Primary series-
+
+- Under 13 months of age: Three 0.5 ml doses, with an interval of at least four weeks between doses, the first dose to be given not earlier than two months of age.
+- 13 months of age and over: A single 0.5 ml dose. This vaccine is not recommended for healthy children aged more than four years.
+
+Booster-
+
+- Following completion of a primary series in which all three doses were administered before the age of 6 months, an additional (fourth) dose of Hib conjugate vaccine should be administered. The timing of the Hib conjugate booster dose should be in accordance with official recommendations.
+- Children who were primed with this vaccine may be boosted with this vaccine or with another Hib conjugate vaccine. Similarly, This vaccine may be used to boost children who were primed with other Hib conjugate vaccines.
+
","
+- The vaccine should be shaken before use.
+- This should be administered intramuscularly in the anterolateral area of the thigh in infants. Do not administer intravascularly.
+- One dose is 0.5 ml. For single and ten dose/vial presentations a sterile syringe and sterile needle should be used for each injection.
+- Patients with thrombocytopenia or bleeding disorders may be vaccinated by the subcutaneous route.
+
","In clinical studies, concomitant administration of this vaccine with various vaccines containing the following antigens did not affect immune responses to these other antigens: diphtheria and tetanus toxoids, whole cell or acellular pertussis components, polioviruses (live attenuated), hepatitis B, or live attenuated measles, mumps and rubella viruses. As with other vaccines it may be expected that in patients receiving immunosuppressive therapy or patients with immunodeficiency, an adequate immune response may not be achieved. Different injectable vaccines must not be mixed in the same syringe and should be administered at different injection sites.
","Do not vaccinate in case of any known hypersensitivity to the vaccine components or a severe reaction to a previous dose. This vaccine will not harm individuals previously infected with the Hib bacteria. As with other vaccines, vaccination should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor non-febrile infection, however, is not a contra-indication to vaccination.
","Very common adverse reactions are tenderness, erythema, induration, unusual crying, irritability, vomiting, diarrhoea, change in eating habits, sleepiness, fever.
","No reproductive studies have been conducted in animals since vaccination against Hib in adults is uncommon. There is no accurate information on the safety of this vaccine in pregnancy therefore this vaccine should not be used in pregnancy or during lactation.
","In the presence of congenital or acquired immune deficiency, this vaccine may be administered but a protective immune response may not be elicited. Although a limited immune response to the diphtheria toxin component may occur, vaccination with this vaccine does not substitute for routine diphtheria vaccination. This vaccine does not elicit protection against diseases caused by other H.influenzae serotypes and does not protect against meningitis caused by other pathogenic agents. This vaccine should under no circumstances be administered intravascularly.
",,,,,"This vaccine has a shelf life of 2 years provided that the packaging is integral and the product correctly stored. Do not use the product after the expiry date. This vaccine should be stored and transported at a temperature between 2°C and +8°C.
",11
+1452,Guaifenesin + Levomenthol + Diphenhydramine,guaifenesin-levomenthol-diphenhydramine-1452,,Combined cough expectorants,Productive cough,"This syrup is indicated for the relief of cough, associated congestive symptoms and aiding restful sleep
","Combined cough expectorants
","Guaifenesin is reported to reduce the viscosity of tenacious sputum end is used as an expectorant. Levomenthol has mild local anesthetic and decongestant properties. Diphenhydramine Hydrochloride possesses antitussive, antihistaminic, and anticholinergic properties.
","For adults and children over 12 years: 2 teaspoonfuls syrup 4 times a day or as directed by the physicians. Do not take more than 8 teaspoonful syrup in 24 hours.
Use in Children & Adolescents: The efficacy and safety of Guaifenesin have not been established in pediatric patients and adolescents.
",,"This syrup contains Diphenhydramine Hydrochloride and therefore may potentiate the effects of alcohol, and other CNS depressants. As Diphenhydramine Hydrochloride possess some anticholinergic activity, the effects of anticholinergics (e.g. some psychotrophic drugs and atropine) may be potentiated by this product. This may result in tachycardia, mouth dryness, gastrointestinal disturbances (e.g. colic), urinary retention and headache.
","This syrup is contraindicated in individuals with known hypersensitivity to the product or any of its components. This medicine should not be administered to patients who have received treatment with MAOIs within last two weeks.
","This syrup may cause drowsiness, dizziness, nausea and vomiting, gastro-intestinal disturbance, dry mouth, nose and throat difficulty in urination or blurred vision.
","As with any other medicine, care should be taken In administration during pregnancy. This product has not been associated with adverse effects in the human fetus or suckling infant.
","This syrup may cause drowsiness; if affected, individuals should not drive or operate machinery. Diphenhydramine Hydrochloride should not be taken by individuals with narrow-angle glaucoma or symptomatic prostatic hypertrophy. This product should not be used for persistent or chronic cough, such as occurs with asthma, or where cough is accompanied by excessive secretions unless directed by a physician.
",,"When taken in excess, Guaifenesin may cause renal calculi. Treatment of overdose should be symptomatic and supportive.
",,,"Store at a temperature not exceeding 30° C in a dry place. Protect from light & moisture. Keep out of the reach of children.
",11
+1455,Guaifenesin + Dextromethorphan + Menthol,guaifenesin-dextromethorphan-menthol-1455,,Combined cough expectorants,Sore throat,"Fast & effective relief of Chest congestion, Cough, Sore throat
","Combined cough expectorants, Combined cough suppressants
","Guaifenesin is an expectorant. It helps loosen congestion in the chest and throat, making it easier to cough out through the mouth.
Dextromethorphan Hydrobromide is a cough suppressant. It affects the signals in the brain that trigger cough reflex.
Menthol is an organic compound made synthetically or obtained from corn mint, peppermint, or other mint oils. It has local anesthetic and counterirritant qualities, and it is widely used to relieve minor throat irritation.
","Adult Use Only (12 years and over): 2 teaspoonful syrup (10 ml) every 6 hours. Maximum 8 teaspoonful syrup (40 ml)/day.
",,"Possible reactions systemically may occur with acetaminophen / hydrocodone, diphenhydramine, escitalopram, acetaminophen / codeine, alprazolam and ondansetron.
","If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
","Common side effects may include:
+
+- Dizziness, drowsiness;
+- Gastrointestinal disturbance
+- Feeling nervous, restless, anxious, or irritable
+
+Do not use for children less than 12 years of age.
","Dextromethorphan Hydrobromide-guaifenesin have been assigned to pregnancy category C by the FDA. There are no controlled data on this combination product in human pregnancy.
Dextromethorphan Hydrobromide-guaifenesin is only recommended for use during pregnancy when benefit outweighs risk.
There are no data on the excretion of dextromethorphan-guaifenesin into human milk. In nursing infants, a decision should be made to discontinue. There are no human studies on the use of menthol during pregnancy; thus, its risk is undetermined.
","Talk to a doctor before using this product if you have asthma, chronic lung disease or shortness of breath, persistent/chronic cough, or taking a drug for depression, including monoamine oxidase (MAO) inhibitor drugs.
",,"Overdosage with guaifenesin is unlikely to produce toxic effects since its toxicity is low. In severe cases of overdosage, treatment should be aimed at reducing further absorption of the drug. Gastric emptying (emesis and/or gastric lavage) is recommended as soon as possible after ingestion. Overdosage with Dextromethorphan Hydrobromide may produce excitement and mental confusion. Very high doses may produce respiratory depression. One case of toxic psychosis (hyper-activity, marked visual and auditory hallucinations) after ingestion of a single 300 mg dose of Dextromethorphan Hydrobromide has been reported. Menthol can be harmful in large amounts. Symptoms may include abdominal pain, diarrhea, nausea and vomiting, dizziness, rapid breathing etc.
",,,"Keep out of the reach of children. Keep in a cool & dry place. Protect from light.
",11
+535,Griseofulvin [Microsize],griseofulvin-microsize-535,https://medex.com.bd/attachments/Cuq1wusFFLVI2UZ6Gmawq6uZY6WW3p/griseofulvin-microsize-oral-suspension-prescribing-information,Other Antifungal preparations,Nail fungal infections,"Major indications for griseofulvin are:
+
+- Tinea capitis (ringworm of the scalp)
+- Tinea corporis (ringworm of the body)
+- Tinea pedis (athlete's foot)
+- Tinea unguium (onychomycosis; ringworm of the nails)
+- Tinea cruris (ringworm of the thigh)
... Read more
Major indications for griseofulvin are:
+
+- Tinea capitis (ringworm of the scalp)
+- Tinea corporis (ringworm of the body)
+- Tinea pedis (athlete's foot)
+- Tinea unguium (onychomycosis; ringworm of the nails)
+- Tinea cruris (ringworm of the thigh)
+- Tinea barbae (barber's itch)
+
+Griseofulvin inhibits the growth of those genera of fungi that commonly cause ringworm infections of the hair, skin, and nails, such as:
+
+- Trichophyton rubrum
+- Trichophyton tonsurans
+- Trichophyton mentagrophytes
+- Trichophyton interdigitalis
+- Trichophyton verrucosum
+- Trichophyton sulphureum
+- Trichophyton schoenleini
+- Microsporum audouini
+- Microsporum canis
+- Microsporum gypseum
+- Epidermophyton floccosum
+- Trichophyton megnini
+- Trichophyton gallinae
+- Trichophyton crateriform
+
+
Note: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical anti-fungal agents alone.
","Other Antifungal preparations
","Griseofulvin is fungistatic, however the exact mechanism by which it inhibits the growth of dermatophytes is not clear. It is thought to inhibit fungal cell mitosis and nuclear acid synthesis. It also binds to and interferes with the function of spindle and cytoplasmic microtubules by binding to alpha and beta tubulin. It binds to keratin in human cells, then once it reaches the fungal site of action, it binds to fungal microtubes thus altering the fungal process of mitosis.
","Accurate diagnosis of the infecting organism is essential. Identification should be made either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium.
Medication must be continued until the infecting organism is completely eradicated as indicated by appropriate clinical or laboratory examination. Representative treatment periods are tinea capitis, 4 to 6 weeks; tinea corporis, 2 to 4 weeks; tinea pedis, 4 to 8 weeks; tinea unguium- depending on rate of growth- fingernails, at least 4 months; toenails, at least 6months.
General measures in regard to hygiene should be observed to control sources of infection or reinfection. Concomitant use of appropriate topical agents is usually required, particularly in treatment of tinea pedis since in some forms of athlete's foot, yeasts and bacteria may be involved. Griseofulvin will not eradicate the bacterial or monilial infection.
Adults: A daily dose of 500 mg will give a satisfactory response in most patients with tinea corporis, tinea cruris, and tinea capitis. For those fungus infections more difficult to eradicate such as tinea pedis and tinea unguium, a daily dose of 1.0 gm is recommended.
Children: Approximately 5 mg per pound of body weight per day is an effective dose for most children. On this basis the following dosage schedule for children is suggested:
+
+- Children weighing 30 to 50 pounds: 125 mg to 250 mg daily.
+- Children weighing over 50 pounds: 250 mg to 500 mg daily.
+
","Should be taken with food. Take immediately after meals.
","Patients on warfarin-type anticoagulant therapy may require dosage adjustment of the anticoagulant during and after griseofulvin therapy. Concomitant use of barbiturates usually depresses griseofulvin activity and may necessitate raising the dosage.
The concomitant administration of griseofulvin has been reported to reduce the efficacy of oral contraceptives and to increase the incidence of breakthrough bleeding.
","This drug is contraindicated in patients with porphyria, hepatocellular failure, and in individuals with a history of hypersensitivity to griseofulvin.
Two cases of conjoined twins have been reported in patients taking griseofulvin during the first trimester of pregnancy. Griseofulvin should not be prescribed to pregnant patients.
","When adverse reactions occur, they are most commonly of the hypersensitivity type such as skin rashes, urticaria and rarely, angioneurotic edema or erythemamultiforme-like drug reaction, and may necessitate withdrawal of therapy and appropriate countermeasures. Paresthesias of the hands and feet have been reported rarely after extended therapy. Other side effects reported occasionally are oral thrush, nausea, vomiting, epigastric distress, diarrhea, headache, fatigue, dizziness, insomnia, mental confusion and impairment of performance of routine activities.
Proteinuria and leukopenia have been reported rarely. Administration of the drug should be discontinued if granulocytopenia occurs. When rare, serious reactions occur with griseofulvin, they are usually associated with high dosages, long periods of therapy, or both.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Patients on prolonged therapy with any potent medication should be under close observation. Periodic monitoring of organ system function, including renal, hepaticand hemopoietic, should be done.
Since griseofulvin is derived from species of penicillin, the possibility of cross sensitivity with penicillin exists; however, known penicillin-sensitive patients have been treated without difficulty.
Since a photosensitivity reaction is occasionally associated with griseofulvin therapy, patients should be warned to avoid exposure to intense natural or artificial sunlight. Should a photosensitivity reaction occur, lupus erythematosus may be aggravated.
",,,,,"Store between 15-30° C.
",11
+534,Granisetron,granisetron-534,https://medex.com.bd/attachments/rRVNX1mxiQkIysscjOMUEqoaLzPdmz/granisetron-tablets-prescribing-information,Supportive Care Therapy,Vomiting,"Granisetron Tablet is indicated for Nausea and vomiting associated with initial and repeat course of emetogenic cancer therapy, including high dose of cisplatin. Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.
Granisetron ... Read more
Granisetron Tablet is indicated for Nausea and vomiting associated with initial and repeat course of emetogenic cancer therapy, including high dose of cisplatin. Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.
Granisetron Injection is indicated for: The prevention of nausea and vomitng associated with initial and repeat courses of emetogenic cancer chemotherapy, therapy including high dose cisplatin. The prevention and treatment of post operative nausea and vomiting.
","Anti-emetic drugs, Supportive Care Therapy
","Granisetron is a highly selective 5-HT3 receptor antagonist with little or no affinity for other serotonin receptors. It blocks serotonin peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone.
Serotonin receptors of the 5-HT3 type are located peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. During chemotherapy that induces vomiting, mucosal enterochromaffin cells release serotonin, which stimulates 5-HT3 receptors. This evokes vagal afferent discharge, inducing vomiting. Animal studies demonstrate that, in binding to 5-HT3 receptors, granisetron blocks serotonin stimulation and subsequent vomiting after emetogenic stimuli such as cisplatin. In the ferret animal model, a single granisetron injection prevented vomiting due to high-dose cisplatin or arrested vomiting within 5 to 30 seconds.
In most human studies, granisetron has had little effect on blood pressure, heart rate or ECG. No evidence of an effect on plasma prolactin or aldosterone concentrations has been found in other studies.
","Tablet-
+
Emetogenic Chemotherapy: The recommended adult dosage of oral Granisetron is 2 mg once daily or 1 mg twice daily. In the 2 mg once-daily regimen, two 1 mg tablets is given up to 1 hour before chemotherapy. In the 1 mg twice-daily regimen, the first 1 mg tablet is given up to 1 hour before chemotherapy, and the second tablet is given 12 hours after the first. Either regimen is administered only on the day(s) chemotherapy is given. Continued treatment, while not on chemotherapy, has not been found to be useful.
+
Injection-
+
Chemotherapy Induced Nausea and Vomiting:
+
+- Adults: The recommended dosage for Granisetron Injection is 10 mcg/kg administered intravenously within 30 minutes before initiation of chemotherapy, and only on the day(s) chemotherapy is given. Granisetron Injection may be administered intravenously either undiluted over 30 seconds, or diluted with 0.9% Sodium Chloride or 5% Dextrose and infused over 5 minutes. As a general precaution, Granisetron Injection should not be mixed in solution with other drugs.
+- Paediatric Patients: The recommended dose in paediatric patients 2 to 16 years o f age is 10 mcg/kg. Paediatric patients under 2 years o f age have not beenstudied.
+- Geriatric Patients, Renal Failure Patients or Hepatically Impaired Patients: No dosage adjustment is required.
+
+
Treatment of Postoperative Nausea and Vomiting:
+
+- Adults: The recommended dosage for prevention of postoperative nausea and vomiting is, a single dose of 1 mg of Granisetron should be diluted to 5 ml andadministered as a slow intravenous injection (over 30 seconds). Administration should be completed prior to induction of anesthesia. The recommended dosage for the treatment of nausea and vomiting after surgery is 1 mg of Granisetron undiluted, administered intravenously over 30 seconds.
+- Paediatric Patients: Safety and effectiveness of Granisetron Injection have not been established in paediatric patients for the prevention or treatment of post operative nausea or vomiting.
+- Geriatricpatients, Renal Failure Patients or Hepatically Impaired Patients: No dosage adjustment is required.
+
",,"Induced metabolism with phenobarbital. Risk of serotonin syndrome with other serotonergic agents e.g. SSRIs, and serotonin and norepinephrine reuptake inhibitors (SNRIs). Altered clearance with CYP enzyme inducers or inhibitors. Concomitant use with drugs known to prolong QT interval may result in clinical consequences.
","Granisetron is contraindicated in patients with known hypersensitivity to granisetron.
","Headache, insomnia, constipation, diarrhoea, elevated hepatic transaminases; QT prolongation; bradycardia, palpitations, sick sinus syndrome, chest pain. Application site reactions (transdermal): Rash, pain, erythema, pruritus, irritation, burn, vesicles, urticaria, discolouration; patch non-adhesion.
","Pregnancy Category B. No evidence of impaired fertility or harm to the animal fetus have been found. However, this drug may be used in pregnancy only if clearly needed. It is not known whether granisetron is excreted in human milk. So cautions hould be exercised when granisetron is administered to a nursing mother.
","Patient with cardiac co-morbidities, on cardiotoxic chemotherapy and/or woth concomitant electrolyte abnormalities. May mask progressive ileus and/or gastric distention. Childn. Pregnancy and lactation.
","Pediatric Uses: Safety and effectiveness of granisetron in paediatric patients under 2 years have not been established.
Geriatric use: Efficacy and safety were maintained with increasing age
",,,,"Store between 15-30°C. Protect from light.
",11
+555,Gramacidin + Neomycin + Polymixin B,gramacidin-neomycin-polymixin-b-555,https://medex.com.bd/attachments/zMnVSVCnOxJK2RKraevCwirvk2Rxl2/gramacidin-neomycin-polymixin-b-prescribing-information,Ophthalmic antibacterial drugs,Superficial bacterial infections,"Gramicidin, Neomycin and Polymyxin B Sulfates ophthalmic solution is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.
","Ophthalmic antibacterial drugs
","Neomycin is bactericidal for many gram-positive and gram-negative organisms. It is an aminoglycoside antibiotic which inhibits protein synthesis by binding with ribosomal RNA and causing misreading of the bacterial genetic code.
Polymyxin B is bactericidal for a variety of gram-negative organisms. It increases the permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane.
Gramicidin is bactericidal for a variety of gram-positive organisms. It increases the permeability of the bacterial cell membrane to inorganic cations by forming a network of channels through the normal lipid bilayer of the membrane.
","Instill one or two drops into the affected eye every 4 hours for 7 to 10 days. In severe infections, dosage may be increased to as much as two drops every hour.
",,,"This product is contraindicated in those persons who have shown hypersensitivity to any of its components.
","Adverse reactions have occurred with the anti-infective components of this product. The exact incidence is not known. Reactions occurring most often are allergic reactions including itching, swelling, and conjunctival erythema . More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely. Local irritation on instillation has also been reported.
","Pregnancy Category C. Adequate animal reproductive studies have not been conducted with gramicidin, neomycin & polymyxin B. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only if clearly needed.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.
","As with other antibiotic preparations, prolonged use of this product may result in overgrowth of nonsusceptible organisms including fungi. If superinfection occurs, appropriate measures should be initiated.
Bacterial resistance to this product may also develop. If purulent discharge, inflammation or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.
There have been reports of bacterial keratitis associated with the use of topical ophthalmic products in multiple-dose containers which have been inadvertently contaminated by patients, most of whom had a concurrent corneal disease or a disruption of the ocular epithelial surface .
Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.
","Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
",,,,"Should be stored in cool and dry place
",10
+1554,Golimumab,golimumab-1554,https://medex.com.bd/attachments/tvbn0xB0smUnejMzSDtXB88v4dGWRs/golimumab-prescribing-information,Drugs used for Rheumatoid Arthritis,Ulcerative colitis,"Golimumab is a tumor necrosis factor (TNF) blocker indicated for the treatment of adult patients with:
+
+- Moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate
+- Active psoriatic arthritis (PsA) alone, or in combination with methotrexate
+- Active ankylosing spondylitis (AS)
... Read more
Golimumab is a tumor necrosis factor (TNF) blocker indicated for the treatment of adult patients with:
+
+- Moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate
+- Active psoriatic arthritis (PsA) alone, or in combination with methotrexate
+- Active ankylosing spondylitis (AS)
+- Moderate to severe Ulcerative colitis (UC) with an inadequate response or intolerant to prior treatment or requiring continuous steroid therapy inducing and maintaining clinical response, improving endoscopic appearance of the mucosa during induction, inducing clinical remission, achieving and sustaining clinical remission in induction responders
+
","Drugs used for Rheumatoid Arthritis
","Golimumab is a human monoclonal antibody that binds to both the soluble and transmembrane bioactive forms of human TNFα. This interaction prevents the binding of TNFα to its receptors, thereby inhibiting the biological activity of TNFα (a cytokine protein). There was no evidence of the golimumab antibody binding to other TNF superfamily ligands; in particular, the golimumab antibody did not bind or neutralize human lymphotoxin. Golimumab did not lyse human monocytes expressing transmembrane TNF in the presence of complement or effector cells.
Elevated TNFα levels in the blood, synovium, and joints have been implicated in the pathophysiology of several chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. TNFα is an important mediator of the articular inflammation that is characteristic of these diseases. The exact mechanism by which golimumab treats ulcerative colitis is unknown. Golimumab modulated the in vitro biological effects mediated by TNF in several bioassays, including the expression of adhesion proteins responsible for leukocyte infiltration (E-selectin, ICAM-1 and VCAM-1) and the secretion of proinflammatory cytokines (IL-6, IL-8, G-CSF and GM-CSF).
","Dosage in Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis: The Golimumab dose regimen is 50 mg administered by subcutaneous injection once a month. For patients with rheumatoid arthritis (RA), Golimumab should be given in combination with methotrexate and for patients with psoriatic arthritis (PsA) or ankylosing spondylitis (AS), Golimumab may be given with or without methotrexate or other nonbiologic Disease Modifying Antirheumatic Drugs (DMARDs). For patients with RA, PsA, or AS, corticosteroids, non-biologic DMARDs, and/or NSAIDs may be continued during treatment with Golimumab.
Dosage in Moderately to Severely Active Ulcerative Colitis: The recommended Golimumab induction dosage regimen is a 200-mg subcutaneous injection at Week 0, followed by 100 mg at Week 2, and then maintenance therapy with 100 mg every 4 weeks.
",,"
+- Abatacept: Increased risk of serious infection
+- Anakinra: Increased risk of serious infection
+- Live vaccines/therapeutic infectious agents: Avoid use with Golimumab
+
",,"Most common adverse reactions (incidence > 5%) are upper respiratory tract infection, nasopharyngitis, injection site reactions
","There are no adequate and well-controlled trials of Golimumab in pregnant women. There is no information regarding the presence of Golimumab in human milk, the effects on
breastfed infants, or the effects on milk production.
","Serious Infections: Do not start Golimumab during an active infection. If an infection develops, monitor carefully, and stop Golimumab if infection becomes serious
Invasive Fungal Infections: For patients who develop a systemic illness on Golimumab, consider empiric antifungal therapy for those who reside in or travel to regions where mycoses are endemic
Hepatitis B Reactivation: Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop Golimumab and begin antiviral therapy
Malignancies: Incidence of lymphoma was greater than in the general U.S. population. Cases of other malignancies have been observed among patients receiving TNF blockers
Congestive Heart Failure: Worsening, or new onset, may occur. Stop Golimumab if new or worsening symptoms occur
Demyelinating Disorders: Exacerbation or new onset may occur
Lupus-like Syndrome: Discontinue Golimumab if symptoms develop
Hypersensitivity Reactions: Serious systemic hypersensitivity reactions including anaphylaxis may occur
","Pediatric Use: Effectiveness of Golimumab in pediatric patients less than 18 years of age has not been established.
",,,,"Golimumab must be refrigerated at 2ºC to 8ºC and protected from light. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake
",10
+1892,Glycopyrronium Bromide + Formoterol Fumarate,glycopyrronium-bromide-formoterol-fumarate-1892,https://medex.com.bd/attachments/IxocpshUY0Qb7NIRetvjoB5XrmFNhy/glycopyrronium-bromide-formoterol-fumarate-prescribing-information,,,"It is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
",,"This preparation contains two bronchodilators: Glycopyrronium is a long-acting muscarinic antagonist (LAMA) and Formoterol is a long-acting β2-adrenergic agonist (LABA) with a rapid onset of action. Glycopyrronium has similar afnity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological efects through inhibition of the M3 receptor at the smooth muscle leading to bronchodilation. Formoterol causes direct relaxation of airway smooth muscle as a consequence of the increase in cyclic AMP through activation of adenylyl cyclase.
","Adults: Should be administered as 2 puffs twice daily, in the morning and in the evening.
Use in patients with severe renal impairment should be considered if the potential benefit of the treatment outweighs the risk.
",,"
+- Other adrenergic drugs may potentiate efect. Use with caution.
+- Xanthine derivatives, steroids, diuretics or non-potassium sparing diuretics may potentiate hypokalemia or EDG changes. Use with caution.
+- Diuretics: Use with caution.
+- Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate efect of formoterol fumarate on cardiovascular system.
+- Beta-Blockers: Use with caution and only when medically necessary.
+- Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administrations of this combination with other anticholinergic-containing drugs.
+
","All LABAs are contraindicated in patients with asthma without use of a long-term asthma control medication. This preparation is also contraindicated in patients with hypersensitivity to glycopyrronium bromide, formoterol fumarate or to any component of the product.
","The most common adverse reactions include cough and urinary tract infection. Possible side efects are sudden breathing problems, headache, tremor, nervousness, rash, swelling of the face, mouth and tongue, hives, increase blood pressure, chest pain, irregular heartbeat, muscle spasm, muscle weakness, eye pain or discomfort and urinary retention.
","There are no data on the use of this preparation in pregnant women.
","
+- This combination should not be used with an additional medicine containing a LABA because of risk of overdose.
+- Not indicated for the relief of acute bronchospasm
+- Do not initiate in acutely deteriorating COPD or to treat acute symptoms
+- If paradoxical bronchospasm occurs, discontinue this combination and institute alternative therapy
+- Use with caution in patients with cardiovascular disorders
+- Use with patients with convulsive disorders, thyrotoxicosis, diabetes mellitus and ketoacidosis.
+- Be alert to hypokalemia and hyperglycemia
+- Worsening of narrow angle glaucoma may occur. Use with caution with patients with narrow-angle glaucoma
+- Worsening of urinary retention may occur. Use with caution with patients with prostatic hyperplasia or bladder-neck obstruction
+
",,,,,"Do not store above 30°C. Do not expose to temperatures higher than 50°C. Do not pierce the pressurized container. Keep out of the reach of the children.
",9
+2028,Glycopyrronium Bromide (Respirator Solution),glycopyrronium-bromide-respirator-solution-2028,,Bronchodilator,Emphysema,"Glycopyrrolate is indicated for the long-term maintenance treatment for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
","Bronchodilator
","Glycopyrrolate is a long-acting muscarinic antagonist which has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation.
","The recommended dose of Glycopyrrolate is the inhalation one ampoule twice-daily. It should be administered at the same time of the day, (1 ampoule in the morning and 1 ampoule in the evening), every day.
",,"Sympathomimetics and Steroids: In clinical studies, concurrent administration of glycopyrrolate and other drugs commonly used in the treatment of COPD including sympathomimetics (long and short-acting beta2 agonists), anticholinergics (short-acting anti-muscarinic antagonists), oral and inhaled steroids showed no increases in adverse drug reactions.
Anticholinergics: There is a potential for an additive interaction with concomitantly used anticholinergic medications. Therefore, avoid unnecessary co-administration of glycopyrrolate with other anticholinergic containing drugs as this may lead to an increase in anticholinergic effects.
","Glycopyrrolate is contraindicated in patients with a hypersensitivity to glycopyrrolate or any of the ingredients (Sodium Chloride, Citric Acid Monohydrate, Sodium Hydroxide, Hydrochloric Acid and Water for Injection).
","The following adverse reactions are found:
+
+- shortness of breath,
+- urinary tract infection,
+- wheezing,
+- upper respiratory tract infection,
+- runny nose,
+- fatigue.
+
","There are no adequate and well-controlled studies in pregnant women. Glycopyrrolate should only be used during pregnancy if the expected benefit to the patient outweighs the potential risk to the fetus. Glycopyrrolate is not indicated for use in children.
","Glycopyrrolate should not be initiated in patients during acutely deteriorating or potentially life-threatening episodes of COPD. Glycopyrrolate should not be used as rescue therapy for the treatment of acute episodes of bronchospasm.
",,"An overdose of glycopyrrolate may lead to anticholinergic signs and symptoms such as nausea, vomiting, dizziness, lightheadedness, blurred vision, increased intraocular pressure (causing pain, vision disturbances, or reddening of the eye), obstipation or difficulties in voiding
",,,"Keep in a dry place and store below 30°C. Protect from light and keep out of the reach of children.
",11
+1196,Hydrogen peroxide,hydrogen-peroxide-1196,https://medex.com.bd/attachments/47Bpdqrs5XBvnNVoudgpskBVD05juQ/hydrogen-peroxide-prescribing-information,Oxidising agent with antibacterial and antiviral properties,Wound cleansing,"Hydrogen peroxide is a mild antiseptic used on the skin to prevent infection of minor cuts, scrapes, and burns. It may also be used as a mouth rinse to help remove mucus or to relieve minor mouth irritation (e.g., due to canker/cold sores, gingivitis) ... Read more
Hydrogen peroxide is a mild antiseptic used on the skin to prevent infection of minor cuts, scrapes, and burns. It may also be used as a mouth rinse to help remove mucus or to relieve minor mouth irritation (e.g., due to canker/cold sores, gingivitis). This product works by releasing oxygen when it is applied to the affected area. The release of oxygen causes foaming, which helps to remove dead skin and clean the area. This product should not be used to treat deep wounds, animal bites, or serious burns.
","Oxidising agent with antibacterial and antiviral properties
","Hydrogen peroxide is an oxidising agent with antibacterial and antiviral activity. It is used as an antiseptic, disinfectant, and deodorant. It also has a mild haemostatic action. It exerts its antiseptic action partly by its ready release of oxygen when applied to tissues, but this effect is reduced in the presence of organic matter. The mechanical effect of effervescence may be more useful for wound cleansing than the antimicrobial action.
","Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist. Do not use in the eyes or apply over large areas of skin.
If you are using this product on the skin, clean the affected area before use. Apply a small amount of product on the affected area, usually 1 to 3 times daily or as directed by your doctor. If you apply a bandage after using this product, let the area dry first.
If you are using this product as a mouth rinse, mix with an equal amount of water before using. Swish in the mouth over the affected area for at least 1 minute, then spit out. Do not swallow this product. Rinse up to 4 times daily or as directed by your dentist or doctor.
Use this product regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day.
Tell your doctor if your condition does not improve in 7 days or if it worsens. If you think you may have a serious medical problem, seek immediate medical attention.
",,"If you are using this product under your doctor's direction, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
","Inj or instillation of hydrogen peroxide into closed body cavities.
","Irritating burns on the skin and mucous membranes (strong solutions); reversible hypertrophy of the papillae of the tongue with continued use as mouthwash; gas embolism, rupture of the colon, proctitis, ulcerative colitis and gangrene of the intestines have occurred following colonic lavage with hydrogen peroxide solution.
","This product is safe to use during pregnancy. It is unlikely that this product passes into breast milk. Consult your doctor before breast-feeding.
","Before using hydrogen peroxide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
",,,,,"Store at 15-30° C.
",10
+1882,Hydrocortisone Butyrate,hydrocortisone-butyrate-1882,https://medex.com.bd/attachments/hrQV5G6q2uNEoCeoO5FGbG6qDtCi26/hydrocortisone-butyrate-prescribing-information,,,"প্রাপ্তবয়স্কদের ক্ষেত্রে কর্টিকোস্টেরয়েডের প্রতিক্রিয়াশীল ডার্মাটোসিস প্রদাহজনিত ঘটনা এবং চুলকানি থেকে পরিত্রানের জন্য টপিক্যাল হাইড্রোকর্টিসােন বিউটাইরেট ব্যবহার করা হয়। ৩ মাস থেকে ১৮ বছর বয়সের পেডিয়াট্রিক রােগীদের মৃদু থেকে মাঝারি এটোপিক ডার্মাটাইটিসের চিকিৎসায় ব্যবহার করা হয়।
",,"টপিক্যাল কর্টিকোস্টেরয়েডগুলাে প্রদাহনাশক , এন্টিরাইটিক এবং রক্তনালীর সংকোচক জাতীয় গুণাগুণ বহন করে। কর্টিকোস্টেরয়েড সমূহ ফসপপালাইপেজ এ -২ নিরোধক প্রােটিন- লিপােকটিনসমূহকে উদ্দীপ্ত করার মাধ্যমে কাজ করে থাকে। এই প্রােটিনসমূহ এরাকিডোনিক এসিডের নিঃসরণকে বাধা দিয়ে প্রদাহ সৃষ্টিকারী প্রােস্টাগ্লান্ডিন এবং লিউকোট্রেইনের মত শক্তিশালী উপাদানসমূহের কাজ নিয়ন্ত্রণ করে। কোষঝিল্লির যসপােলিপিড থেকে ফসপােলাইপেজ এ -২ এনজাইমের ক্রিয়ায় এরাকিডােনিক এসিড তৈরি হয়। এরাকিডােনিক এসিড কোষঝিল্লির ফসপােলিপিড থেকে ফসপােলাইপেজ এ -২ এনজাইমের ক্রিয়ার মাধ্যমে তৈরি হয়।
","প্রাপ্তবয়স্কদের কর্টিকোস্টেরয়েড সংবেদনশীল ডার্মাটোসিসের জন্য রােগের তীব্রতার উপর নির্ভর করে আক্রান্ত স্থানে দৈনিক দুই থেকে তিন বার পাতলা করে ক্রীমের প্রলেপ দিয়ে মসূনভাবে প্রয়ােগ করতে হবে। ৩ মাস থেকে ১৮ বছরের বয়সীদের এটোপিক ডার্মাটাইটিসের জন্য দৈনিক দুইবার করে আক্রান্ত স্থানে ক্রিমের পাতলা প্রলেপ দিয়ে মসৃণভাবে ব্যবহার করতে হবে। চিকিৎসকের নির্দেশনা ব্যতীত ডায়াপার অঞ্চলে হাইড্রোকর্টিসােন বিউটাইবেট প্রয়ােগ করা থেকে বিরত থাকতে হবে। রােগ নিয়ন্ত্রিত হলে ক্রীম প্রয়ােগ বন্ধ রাখতে হবে। ওষুধ প্রয়ােগের দুই সপ্তাহের মধ্যে কোন উন্নতি না হলে রোগ নির্ণয়ের পূনর্মূল্যায়ন প্রয়ােজন হতে পারে। ক্রীমের ব্যবহার ২ সপ্তাহ থেকে ৪ সপ্তাহে উন্নীত কার ক্ষেত্রে এইচপিএর এক্সিস নিবারণ এবং স্থানীয় পার্শ্বপ্রতিক্রিয়া বিবেচনায় নিতে হবে। হাইড্রোকর্টিসােন বিউটাইরেট ৪ সপ্তাহের বেশি ব্যবহারের কার্যকারিতা এবং নিরাপত্তা সুনির্দিষ্ট নয়। চিকিৎসকের পরামর্শ ব্যতীত অকুসিভ ড্রেসিং (টাইট পরিধেয়) এর ক্ষেত্রে হাইড্রোকর্টিসােন বিউটাইরেট ব্যবহার করবেন না।
শিশুদের ক্ষেত্রে ব্যবহারঃ তিন মাসের কম বয়সী শিশুদের প্রয়ােগের ক্ষেত্রে ওষুধের নিরাপত্তা এবং কার্যকারিতা সুপ্রতিষ্ঠিত নয়।
বয়স্কদের ক্ষেত্রে ব্যবহারঃ ৬৫ বছরের ঊর্ধ্ব বয়সীদের ক্ষেত্রে ওষুধের নিরাপত্তা এবং কার্যকারিতা সুপ্রতিষ্ঠিত নয়।
",,"হাইড্রোকর্টিসােন বিউটাইরেট এর সাথে কোন ঔষধের প্রতিক্রিয়া নেই।
","হাইড্রোকর্টিসােন বিউটাইরেট এর যে কোন উপাদানের প্রতি সংবেদনশীল প্রতিক্রিনা থাকলে এটি ব্যবহার করা যাবে না।
","প্রথমবার প্রয়ােগের ক্ষেত্রে ত্বকের ব্যবহার্য স্থানে জ্বালা, চুলকানি, শুষ্কত��, লালচেভাব দেখা দিতে পারে। শরীরের সাথে সামঞ্জস্যতার ভিত্তিতে এই প্রভাব সমূহ কয়েকদিনের মধ্যেই অদৃশ্য হয়ে যায়।
","গর্ভকালীন সময়: গর্ভাবস্থায় এই ক্রীম ব্যবহারের কোন পর্যাপ্ত এবং সুনিয়ন্ত্রিত গবেষণা নেই। তাই জ্বণের ঝুঁকির তুলনায় গর্ভবতী মায়ের সুফলতার হার বেশি হলে এই ক্রীমটি ব্যবহার করা যাবে। নিম্ন মাত্রায় সিস্টেমিক সংবহনে প্রয়ােগ করলে পরীক্ষাগারের প্রাণিতে কর্টিকোস্টেরয়েডসমূহ টেরাটোজেনেসিটি প্রদর্শন করে। কিছু কর্টিকোস্টেরয়েড পরীক্ষাগারের প্রাণিতে ত্বকে প্রয়ােগের ফলে টেরাটোজেনেসিটি প্রদর্শন করে।
স্তন্যদানকালীন সময়: কর্টিকোস্টেরয়েডসমূহ ত্বকে প্রয়ােগ করলে তা শােষিত হয়ে মাতৃদুদ্ধে সনাক্তমাত্রায় উপস্থিত থাকার বিষয়ে কোন তথ্য জানা নেই। সিস্টেমিক সংবহনে প্রয়ােগ করলে তা মাতৃদুদ্ধে এমন মাত্রায় উপস্থিত থাকে যা শিশুর দেহে কোন ক্ষতিকর প্রভাব তৈরি করে। তবুও স্তন্যদানকালীন সময়ে ত্বকে কর্টিকোস্টেরয়েড প্রয়ােগের ক্ষেত্রে সাবধানতা অবলম্বন করা জরুরি।
","টপিকাল কর্টিকোস্টেরয়েডসমূহ সিস্টেমিক সংবহনে শােষণ হলে অস্থায়ীভাবে হাইপােথ্যালামিক পিটুইটারি- এড্রেনাল অক্ষের ক্রিয়া কমিয়ে দিতে পারে, তাছাড়া কিছু রােগীর ক্ষেত্রে কুশিং সিনড্রোম, হাইপারগ্লাইসেমিয়া এবং গ্লাইকোজুরিয়ার লক্ষণ দেখা দিতে পারে। অধিক কার্যকরী কর্টিকোস্টেরয়েড ব্যবহার, ত্বকের অধিকাংশ অঞ্চলে ব্যবহার, দীর্ঘমেয়াদি ব্যবহার, টাইট পরিধেয় এইসব ক্ষেত্রে সিস্টেমিক সংবহনে শােষণের মাত্রা বাড়তে পারে। শিশুদের দেহে টপিক্যাল কর্টিকোস্টেরয়েডসমূহ তুলনামূলক বেশি শােষণ হওয়ায় তাদের ক্ষেত্রে। সিস্টেমিক বিষক্রিয়ার আশঙ্কা বেশি থাকে। ঔষধ প্রয়ােগের কারণে স্থানীয় জ্বালাতন দেখা দিলে ওষুধ প্রয়ােগ বন্ধ করে উপযুক্ত ঔষধ নির্বাচন করতে হবে। ত্বকের সংক্রমণ (ইনফেকশন) উপস্থিত থাকলে উপযুক্ত এন্টিফাংগাল বা এন্টি ব্যাকটেরিয়াল উপকরণ প্রয়ােগ করতে হবে। আশানুরূপ প্রতিক্রিয়া না পাওয়া গেলে সংক্রমণ পুরােপুরি নিয়ন্ত্রণ না হওয়া পর্যন্ত কর্টিকোস্টেরয়েড প্রয়ােগ বন্ধ করা উচিত।
",,,,,"২৫° সে. এর উপরে সংরক্ষণ করা যাবে না। আলাে থেকে দূরে রাখুন। ফ্রিজে রাখবেন না। শিশুদের নাগালের বাইর�� রাখুন।
",9
+580,Hydrocortisone Acetate + Neomycin Sulphate,hydrocortisone-acetate-neomycin-sulphate-580,,Local Antipruritic,Wounds,"This preparation is indicated in Allergic skin conditions, Anal or vulvar pruritus, Anal pruritus, Burns, Eczema, Infected wounds & ulcers, Pain and itching caused by sunburn, Pruritic skin conditions, Pruritus, Pruritus and eczema, Pyogenic & seborrhoeic dermatitis, Seborrhoeic dermatitis, Ulcers, Vaginal or rectal irritation, Wounds
","Hydrocortisone & Combined preparations, Local Antipruritic
","Hydrocortisone is a corticosteroid used for its anti-inflammatory and immunosuppressive effects. Its anti-inflammatory action is due to the suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. It may also be used as replacement therapy in adrenocortical insufficiency.
Neomycin is an aminoglycoside antibiotic. It binds to 30S ribosomal subunits of bacterial ribosome thus inhibiting protein synthesis and generating errors in genetic code transcription causing cell death. It acts against many gram-negative aerobes and some gram-positive aerobes. It lacks activity against fungi, viruses and most anaerobic bacteria
","Adult: Apply this preparation into the affected area as directed by physician.
",,"Hydrocortisone: Thiazides may enhance hyperglycaemia and hypokalaemia caused by corticosteroids. Increased incidence of peptic ulcer or Gl bleeding with concurrent NSAIDs admin. Response to anticoagulants altered. Dose of antidiabetics and antihypertensives needs to be increased. Decreases serum cone of salicylates and antimuscarinic agents. Ethanol may enhance gastric mucosal irritation. Reduced efficacy with concurrent use of carbamazepine, phenytoin, primidone, barbiturates and rifampicin. Mutual inhibition of metabolism between ciclosporin and corticosteroids increase plasma cone of both drugs. Enhanced effect in women taking oestrogens or oral contraceptives.
Neomycin: Additive nephrotoxic and neurotoxic effect with other aminoglycosides (e.g. paromomycin), bacitracin, cisplatin, vancomycin, amphotericin B, polymyxin B, colistin and viomycin. Enhanced toxicity with potent diuretics (e.g. ethacrynic acid, furosemide). May impair the absorption of other drugs (e.g. phenoxymethylpenicillin, digoxin, methotrexate and some vit). May reduce the efficacy of OCs. May enhance the effect of acarbose. May enhance the effect of non-depolarising muscle relaxants. May antagonise the parasympathomimetic effect of neostigmine and pyridostigmine. May increase the risk of hypocalcaemia in patients receiving bisphosphonates. May alter INR when given with anticoagulants. May inactivate oral typhoid vaccine.
","Viral/ fungal infections, tubercular or syphilitic lesions, bacterial infections unless used in conjunction with appropriate chemotherapy.
","Burning, itching, irritation, hypopigmentaion, skin atrophy, striae.
","Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","CHR hypertension, DM, epilepsy, elderly, patients on prolonged therapy. Gradual withdrawal, pregnancy and lactation.
",,,,,,9
+1777,Hydrocortisone Acetate + Benzyl Benzoate + Bismuth Subgallate + Bismuth Oxide + Balsam Peru + Zinc Oxide,hydrocortisone-acetate-benzyl-benzoate-bismuth-subgallate-bismuth-oxide-balsam-peru-zinc-oxide-1777,,Other Topical corticosteroids,Acute hemorrhoidal thrombosis,"This ointment is indicated for the comprehensive symptomatic treatment of internal and external hemorrhoids and pruritus ani.
","Other Topical corticosteroids
","This ointment provides antiseptic, astringent, emollient and anti-inflammatory actions. Bismuth oxide, zinc oxide, and bismuth subgallate exert a protective action on mucous membranes They are mildly astringent and are reported to have antiseptic properties Balsam Peru has protective properties and a very mild antiseptic action by virtue of its content of cinnamic and benzoic acids. It is believed to promote the growth of epithelial cells, Benzyl benzoate is used as a solubilizing agent and has mild antiseptic and preservative properties. Hydrocortisone acetate has anti-inflammatory action.
","Adults (over 18 years): To be applied sparingly to the affected area at night, in the morning and after each evacuation up to a maximum of 4 applications a day. Thoroughly cleanse the affected area, dry and apply ointment on a gauze dressing. For internal conditions use the rectal applicator provided. Use for a maximum period of one week. This is topical administration only.
Pediatric Use: This medicine is not recommended for children under 18 years old.
",,"Concurrent use with other corticosteroid preparations either topically or orally may increase the likelihood of systemic effects.
","Tubercular, fungal and most viral lesions including herpes simplex vaccinia and varicella, History of sensitivity to any of the constituents.
","Prolonged or excessive use may produce systemic corticosteroid effects, and use for periods longer than seven days is not recommended. Rarely, there are sensitivity reactions and Patients may occasionally experience transient burning on application especially if the anoderm is not intact.
","There is inadequate evidence of safety in human pregnancy and there may be a very small risk of cleft palate and intrauterine growth retardation as well as suppression of the neonatal hypothalamic-pituitary-adrenal axis. No special precautions required for use during lactation, So Use in pregnancy only when there is no safer alternative and when the disease itself carries risks for the mother or child.
","As with all products containing topical steroids, the possibility of systemic absorption should be borne in mind. Prolonged or excessive use may produce systemic corticosteroid effects, and use for periods longer than seven days is not recommended. The product should be discontinued and the patient advised to consult a medical practitioner if symptoms do not improve or worsen or if rectal bleeding occurs.
",,,,,"Do not store above 30°C & keep in a dry place. Protect from light. Do not freeze Keep out of the reach of children.
",10
+1190,Hydrocortisone Acetate,hydrocortisone-acetate-1190,https://medex.com.bd/attachments/mnj3rZqaLigqYQhJk8RBhPxv7PMbyO/hydrocortisone-acetate-prescribing-information,Other Topical corticosteroids,Vitiligo,"The anti-inflammatory activity of Hydrocortisone Acetate is its main therapeutic property. It also has immunosuppressant and antimitotic actions. Hydrocortisone Acetate is indicated in:
+
+- Primary irritant dermatitis
+- Contact allergic dermatitis
+- Eczema: atopic, infantile, discoid, stasis
... Read more
The anti-inflammatory activity of Hydrocortisone Acetate is its main therapeutic property. It also has immunosuppressant and antimitotic actions. Hydrocortisone Acetate is indicated in:
+
+- Primary irritant dermatitis
+- Contact allergic dermatitis
+- Eczema: atopic, infantile, discoid, stasis
+- Seborrheic dermatitis
+- Lichen simplex and pruritus ani
+- Flexural psoriasis
+- Skin irritations, itching and rashes, for example those caused by insect bites, minor thermal burns, sunburn, etc
+
","Other Topical corticosteroids
","Hydrocortisone binds to the cytosolic glucocorticoid receptor. After binding the receptor the newly formed receptor-ligand complex translocates itself into the cell nucleus, where it binds to many glucocorticoid response elements (GRE) in the promoter region of the target genes. The DNA bound receptor then interacts with basic transcription factors, causing the increase in expression of specific target genes. The anti-inflammatory actions of corticosteroids are thought to involve lipocortins, phospholipase A2 inhibitory proteins which, through inhibition arachidonic acid, control the biosynthesis of prostaglandins and leukotrienes. Specifically glucocorticoids induce lipocortin-1 (annexin-1) synthesis, which then binds to cell membranes preventing the phospholipase A2 from coming into contact with its substrate arachidonic acid. This leads to diminished eicosanoid production. The cyclooxygenase (both COX-1 and COX-2) expression is also suppressed, potentiating the effect. In other words, the two main products in inflammation Prostaglandins and Leukotrienes are inhibited by the action of Glucocorticoids. Glucocorticoids also stimulate the lipocortin-1 escaping to the extracellular space, where it binds to the leukocyte membrane receptors and inhibits various inflammatory events: epithelial adhesion, emigration, chemotaxis, phagocytosis, respiratory burst and the release of various inflammatory mediators (lysosomal enzymes, cytokines, tissue plasminogen activator, chemokines etc.) from neutrophils, macrophages and mastocytes. Additionally the immune system is suppressed by corticosteroids due to a decrease in the function of the lymphatic system, a reduction in immunoglobulin and complement concentrations, the precipitation of lymphocytopenia, and interference with antigen-antibody binding.
","Hydrocortisone Acetate should be applied in a small quantity to the affected area 2 or 3 times daily.
",,,"
+- Infections: bacterial, viral, fungal.
+- Skin ulcers.
+- Hypersensitivity to the preparation.
+
","Hydrocortisone Acetate 1% cream is usually well-tolerated, but if signs of hypersensitivity appear, application should be stopped.
","There is inadequate evidence for safety in human pregnancy. It is recommended that topical corticosteroids should not be used extensively during pregnancy. It is highly unlikely that sufficiently high blood levels of Hydrocortisone are achieved during topical therapy to reach breast milk.
","In infants and children, long-term continuous topical therapy should be avoided where possible, as adrenal suppression can occur. As with all corticosteroids, prolonged application to the face is undesirable.
",,"Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse, the features of hypercorticism may appear and in this situation topical steroids should be discontinued.
",,,"Store in a cool and dry place, away from light. Keep out of reach of children.
",10
+577,Hydrocortisone + Neomycin Sulphate + Polymixin B,hydrocortisone-neomycin-sulphate-polymixin-b-577,https://medex.com.bd/attachments/dyNj6IGTsqNCNGqQAF9qZYkRqDr4YR/hydrocortisone-neomycin-sulphate-polymixin-b-valeant-prescribing-information,Ophthalmic steroid - antibiotic combined preparations,Ocular inflammation,"Hydrocortisone, Neomycin Sulphate & Polymixin B ear drops are indicated for the treatment of bacterial ear infections. It will not work for other types of ear infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.
","Ophthalmic steroid - antibiotic combined preparations, Ophthalmic Steroid preparations
","Polymyxin B sulphate and neomycin sulphate belong to a group of medicines called antibiotics. They kill the germs that can cause ear infections. The anti-infective components in the combination are included to provide action against specific organisms susceptible to them. Neomycin sulfate and polymyxin B sulfate together are considered active against the following microorganisms: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against Serratia marcescens and streptococci, including Streptococcus pneumoniae.
Hydrocortisone belongs to a group of medicines called steroids. It helps to reduce the swelling and irritation caused by the infection. Hydrocortisone suppress the inflammatory response to a variety of agents and they may delay healing. Since Hydrocortisone may inhibit the body’s defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.
","Adults and children over 3 years old: Apply 3 drops into the affected ear up to four times a day, for up to 7 days. Make sure you finish the course of this drop which your doctor has prescribed.
","
+- Shake the closed bottle gently before each use
+- Clean and dry the ears
+- Do not use soap, it may stop the medicine working
+- Do not put the drops in your eyes.
+
","Additive toxicity with neurotoxic, ototoxic or nephrotoxic drugs. Increased neuromuscular blockade and possibly respiratory depression with neuromuscular blocking agents if significant amounts of neomycin absorbed significantly.
","Contraindicated-
+
+- if you are allergic (hypersensitive) to polymyxin B sulphate, neomycin sulphate, hydrocortisone or any of the other ingredients of this preparation.
+- if you are allergic (hypersensitive) to aminoglycoside antibiotics such as framycetin, kanamycin or gentamicin
+- if you have a perforated ear drum
+- if you have either a viral, fungal or tubercular (TB) infection
+- for a child under 3 years old.
+
","The following side effects rarely may happen with this medicine: seem to get worse instead of better, become red, scaly and itchy.
","Do not use this preparation if you are pregnant or plan to get pregnant. Do not breast-feed while using this.
","Caution should be taken if you have kidney problems. If you have a long-standing infection of your outer ear.
",,,,,"Keep out of the reach and sight of children. Do not store above 25°C. Should be stored in the carton to protect it from light.
",11
+576,Hydrocortisone + Lidocaine,hydrocortisone-lidocaine-576,https://medex.com.bd/attachments/wMzHYpIfV8y1hLGJC0AXlxKxQyTvr1/hydrocortisone-lidocaine-prescribing-information,Drugs used in Ano-rectal region,Soreness and discomfort due to hemorrhoids,"Hydrocortisone plus Lidocaine cream is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.
","Drugs used in Ano-rectal region
","Hydrocortisone is a corticosteroid used for its anti-inflammatory and immunosuppressive effects. Its anti-inflammatory action is due to the suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. It may also be used as replacement therapy in adrenocortical insufficiency.
Lidocaine is an amide type local anesthesia. It stabilises the neuronal membrane and inhibits Na ion movements, which are necessary for conduction of impulses. In the heart, lidocaine reduces depolarisation of the ventricles during diastole and automaticity in the His-Purkinje system. Duration of action potential and effective refractory period are also reduced.
","Apply twice daily around the anal opening in a thin layer using an applicator.
",,"This cream should be used with caution together with dental injection anaesthesia, other local anaesthetics or agents structurally related to local anaesthetics of amide type eg, antiarrhythmic drugs (eg, mexiletine), as the toxic effects of these drugs are additive.
Patients treated with class III antiarrhythmic drugs (eg, amiodarone) should be closely observed and ECG monitoring should be considered, as the cardiac effects of lidocaine and class III antiarrhythmic drugs can be additive.
Drugs that inhibit the metabolism of lidocaine (eg, cimetidine or ?-blockers) may cause potentially toxic plasma concentrations when lidocaine is given in repeated high doses over a long time period. Such interactions are of no clinical importance following short-term treatment with lidocaine at recommended doses.
","Patients with a history of hypersensitivity to any of its ingredients.
","Side effects like Rectal bleeding, Swelling of the skin, Adrenal suppression, Anaphylaxis, Angioedema, Cushing syndrome, Hirsutism, Acne, Cutaneous and subcutaneous atrophy, Dry scaly skin, Urticaria.
","Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Lactation: Unknown if distributed in breast milk; exercise caution
","If extensive areas are treated, the possibility of systemic absorption exists. Systemic absorption of topical steroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glycosuria in some patients. If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy.
",,,,,,9
+575,Hydrocortisone,hydrocortisone-575,https://medex.com.bd/attachments/ZJwNGICOgBzlEPt896ugvD3ubJHNVO/hydrocortisone-tablets-prescribing-information,Glucocorticoids,Supplement in adrenal insufficiency during minor surgery under general anaesthesia,"Hydrocortisone is indicated for use in the following conditions:
+
+- Primary or secondary adrenocortical insufficiency
+- Acute adrenocortical insufficiency
+- Shock unresponsive to conventional therapy
+- Congenital adrenal hyperplasia
+- Hypercalcemia associated with cancer
... Read more
Hydrocortisone is indicated for use in the following conditions:
+
+- Primary or secondary adrenocortical insufficiency
+- Acute adrenocortical insufficiency
+- Shock unresponsive to conventional therapy
+- Congenital adrenal hyperplasia
+- Hypercalcemia associated with cancer
+- Nonsuppurative thyroiditis
+- Rheumatic Disorders
+- Dermatologic Diseases (Allergic States, Severe seborrheic dermatitis, Severe psoriasis, Pemphigus, Severe erythema multiforme)
+- Control of severe or incapacitating allergic conditions (Bronchial asthma, Contact dermatitis, Atopic dermatitis, Serum sickness, Seasonal or perennial allergic rhinitis, Drug hypersensitivity reactions, Urticarial transfusion reactions, Acute noninfectious laryngeal edema)
+- Ophthalmic Diseases (Herpes zoster ophthalmicus, Iritis, iridocyclitis, Chorioretinitis, Diffuse posterior uveitis and choroiditis, Optic neuritis)
+- Gastrointestinal Diseases
+- Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
+- Loeffler's syndrome
+- Aspiration pneumonitis
+- Hematologic Disorders (Acquired, autoimmune hemolytic anemia, Idiopathic thrombocytopenic purpura in adults, Secondary thrombocytopenia, Erythroblastopenia)
+- Neoplastic Diseases (Leukemias and lymphomas in adults, Acute leukemia of childhood)
+- Edematous States
+- Acute exacerbations of multiple sclerosis
+
","Glucocorticoids
","Hydrocortisone inhibits prostaglandin synthesis by inhibiting the enzyme phospholipase A2. Hydrocortisone reduces various vasoactive agents released during inflammation. It also controls the rate of protein synthesis.
","Tablet: The initial dosage of Hydrocortisone Tablets may vary from 20 mg to 240 mg of hydrocortisone per day depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, Hydrocortisone Tablets should be discontinued and the patient transferred to other appropriate therapy.
It should be emphasized that dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patients. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If, after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually, rather than abruptly.
Injection:
+
+- Adult: By IM injection or slow IV injection or infusion. The initial dose of Hydrocortisone sterile powder is 100 mg to 500 mg, depending on the severity of the condition. This dose may be repeated at intervals of 2, 4 or 6 hours as indicated by the patient's response and clinical condition.
+- Children: By slow IV injection, up to 1 year 25 mg, 1-5 years 50 mg, 6-12 years 100 mg.
+
",,"Drugs that induce hepatic enzymes such as Phenobarbital, Phenytoin and Rifampin may increase the clearance of corticosteroids and may require increases in corticosteroid dose to achieve the desired response. Drugs such as Troleandomycin and Ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance. Therefore, the dose of corticosteroid should be titrated to avoid steroid toxicity.
","Hydrocortisone is contraindicated in severe systemic fungal infections and patients with known hypersensitivity to any component of this product.
","Hydrocortisone is generally well tolerated except in prolonged high doses. It may cause cardiac arrhythmia, esophageal candidiasis, menstrual irregularity, decreased carbohydrate & glucose tolerance, fluid retention, increased appetite, weight gain, euphoria, mood swings, depression, insomnia, acne etc.
","This should be prescribed in pregnancy and lactation only if absolutely required.
","Hydrocortisone should be used with caution in patients with a history of peptic ulceration as it increases the incidence of peptic ulceration. This drug should be used with caution in patients with congestive heart failure, hypertension, glaucoma, diabetic mellitus and epilepsy.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+573,Hydrochlorothiazide + Triamterene,hydrochlorothiazide-triamterene-573,https://medex.com.bd/attachments/vMSnUd8v6l2vWDMCwBxHF9li6FppSD/hydrochlorothiazide-triamterene-prescribing-information,Combined antihypertensive preparations,Oedema,"This drug is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This medication is a combination of two ""water pills"" (diuretics): triamterene and hydrochlorothiazide. This ... Read more
This drug is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This medication is a combination of two ""water pills"" (diuretics): triamterene and hydrochlorothiazide. This combination is used by people who have developed or are at risk for having low potassium levels on hydrochlorothiazide. It causes you to make more urine, which helps your body get rid of extra salt and water.
This medication also reduces extra fluid in the body (edema) caused by conditions such as heart failure, liver disease, or kidney disease. This can lessen symptoms such as shortness of breath or swelling in your ankles or feet.
","Combined antihypertensive preparations
","Triamterene directly inhibits the exchange of Na for K and hydrogen in the distal renal tubule. Hydrochlorothiazide increases the excretion of Na and Cl ions, and consequently of water, by reducing electrolyte reabsorption from the renal tubules.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so co-administration of anangiotensin converting enzyme (ACE) inhibitor tends to reverse the potassium loss associated with these diuretics.
","Hypertension: Initially, 1 tablet (Hydrochlorothiazide 25 mg and Triamterene 50 mg) daily after the morning meal, adjust thereafter according to response. Max: 4 tab daily.
Oedema: Initially, 1 tablet (Hydrochlorothiazide 25 mg and Triamterene 50 mg) bid. Maintenance: 1 tab daily or 2 tab on alternate days. Max: 4 tab daily.
","Take this medication by mouth as directed by your doctor, usually once daily in the morning with or without food. It is best to avoid taking this medication within 4 hours of your bedtime to prevent having to get up to urinate.
If you also take certain drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take this product at least 4 hours before or at least 4 to 6 hours after these medications.
The dosage is based on your medical condition and response to treatment. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.
","May reduce the renal clearance of lithium. May antagonise diuretic effect with NSAIDs, corticosteroids, oestrogens, combined OCs. Enhanced effect with other hypotensive agents, baclofen, tizanidine. May decrease arterial responsiveness to norepinephrine. Increases responsiveness to tubocurarine. Risk of acute renal failure with indometacin. Increased risk of hyperkalaemia with reboxetine, tacrolimus. Increased risk of ototoxicity and nephrotoxicity with platinum compounds (e.g. cisplatin).
","Hyperkalaemia (≥5.5 mEq/L), hypercalcaemia, diabetic ketoacidosis, Addison’s disease, progressive renal failure, increasing hepatic dysfunction. Concomitant use with K supplements, other K-conserving drugs, including ACE inhibitors.
","Nausea, vomiting, diarrhoea, dizziness, weakness, hypotension, headache, muscle cramps, dry mouth, thirst, anaphylaxis, rash, metabolic acidosis, pancreatitis. Rarely, SLE and photosensitivity.
","Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Patients with prediabetes or DM, diabetic nephropathy, predisposition to gout, history of renal lithiasis. Hepatic or renal impairment. Pregnancy and lactation.
",,"Symptoms: Electrolyte imbalance, nausea, vomiting, weakness, polyuria, lassitude, fever, flushed face, hyperactive deep tendon reflexes, hypotension, cardiac arrhythmias.
Management: Induce immediate evacuation through emesis or gastric lavage. Pressor agents e.g. norepinephrine may be given in case of hypotension.
",,,"Store between 20-25°C. Protect from light.
",12
+549,Hydrochlorothiazide,hydrochlorothiazide-549,https://medex.com.bd/attachments/5plsW22MlluWfziD8HwyNmC2VRArOF/hydrochlorothiazide-prescribing-information,Thiazide diuretics & related drugs,Oedema,"Edema associated with congestive heart failure, hepatic cirrhosis, premenstrual tension and oedema due to various forms of renal dysfunction (i.e. nephrotic syndrome, acute glomerulonephritis, chronic renal failure). Hypertension, either alone or as an adjunct to other antihypertensive drugs.
","Thiazide diuretics & related drugs
","Thiazides such as hydrochlorothiazide promote water loss from the body (diuretics). They inhibit Na+/Cl- reabsorption from the distal convoluted tubules in the kidneys. Thiazides also cause loss of potassium and an increase in serum uric acid. Thiazides are often used to treat hypertension, but their hypotensive effects are not necessarily due to their diuretic activity. Thiazides have been shown to prevent hypertension-related morbidity and mortality although the mechanism is not fully understood. Thiazides cause vasodilation by activating calcium-activated potassium channels (large conductance) in vascular smooth muscles and inhibiting various carbonic anhydrases in vascular tissue.
","Edema: initially 25 to 50 mg daily, reduced for maintenance if possible; maximum 100 mg daily.
Hypertension: 25 mg daily, increased to 50 mg daily if necessary.
Elderly: in some patients, especially the elderly an initial dose of 12.5 mg daily may be sufficient.
Children: An initial dose for children has been 1 to 2 mg per kg body-weight in 2 divided doses. Infants under 6 months may need doses up to 3 mg per kg daily.
",,"Alcohol, barbiturates or narcotics: Co-administration may potentiate orthostatic hypotension. Oral and parenteral antidiabetic drugs may require adjustment of dosage with concurrent use. Other antihypertensive drugs may have an additive effect. Discontinuation of diuretic therapy 2-3 days before the initiation of treatment with an ACE inhibitor may reduce the likelihood of first-dose hypotension. The antihypertensive effect of the drug may be enhanced in the post-sympathectomy patient.
Cholestyramine and colestipol resin: Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resin. Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively. Corticosteroids or ACTH may intensify any Thiazide-induced electrolyte depletion, particularly hypokalaemia. Pressor amines such as adrenaline may show decreased arterial responsiveness when used with hydrochlorothiazide, but this reaction is not enough to preclude their therapeutic usefulness. Non-depolarising muscle relaxants such as tubocurarine may possibly interact with Hydrochlorothiazide to increase muscle relaxation. Non-steroidal anti-inflammatory drugs may attenuate the diuretic and antihypertensive effects of diuretics.
Drug/laboratory tests: Because thiazides may affect calcium metabolism, Hydrochlorothiazide may interfere with tests for parathyroid function.
","Anuria, hypersensitivity to Hydrochlorothiazide or to other sulphonamide-derived drugs, severe renal or hepatic failure, Addison’s disease, hypercalcemia, concurrent lithium therapy.
","Gastro-intestinal system: Anorexia, gastric irritation, nausea, vomiting, cramps, diarrhoea, constipation, jaundice (intrahepatic cholestatic jaundice), pancreatitis, salivary gland inflammation.
Central nervous system: Dizziness, vertigo, paraesthesiae, headache, yellow vision.
Heamatological: Leucopenia, agranulocytosis, thrombocytopenia, aplastic anaemia, haemolytic anaemia.
Cardiovascular: Hypotension, including orthostatic hypotension.
Hypersensitivity: Purpura, photosensitivity, rash, urticaria, necrotising angiitis (vasculitis, cutaneous vasculitis), fever, respiratiory distress including pneumonitis and pulmonary oedema, anaphylactic reactions, toxic epidermal necrolysis.
Metabolic: Hyperglycaemia, glycosuria, hyperuricaema, electrolyte imbalance including hyponatraemia and hypokalaemia.
Renal: Renal dysfunction, interstitial nephritis, renal failure.
Other: Muscle spasm, weakness, restlessness, transient blurred vision, impotence. Whenever side-effects are moderate to severe, thiazide dosage should be reduced or therapy was withdrawn.
","Use in pregnancy: Thiazides cross the placental barrier and appear in cord blood. The use of Hydrochlorothiazide when pregnancy is present or suspected requires, therefore, that the benefits of the drug be weighed against possible hazards to the fetus. These hazards include fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions, which have occurred in the adult. The routine use of diuretics in otherwise healthy pregnant women with or without mild oedema is not recommended, because their use may be associated with hypovolaemia, increased blood viscosity and decreased placental perfusion.
Use in breastfeeding mothers: Thiazides appear in breast milk. If use of the drug is deemed essential, the patient should stop breast-feeding.
","Patients should be carefully monitored for signs of fluid and electrolyte imbalance (hyponatraemia, hypochloraemic alkalosis, hypokalaemia and hypomagnesaemia). It is particularly important to make serum and urine electrolyte determinations when the patient is vomiting excessively or receiving parenteral fluids. Warning signs or symptoms of fluid and electrolyte imbalance include: dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, seizures, confusion, muscle pains or cramps, muscle fatigue, hypotension, oliguria, tachycardia, and gastro-intestinal disturbances such as nausea and vomiting. Hypokalaemia may develop, especially with brisk diuresis, when severe cirrhosis is present, or after prolonged therapy. Hypokalaemia can sensitise or exaggerate the response of the heart to the toxic effects of digitalis (e.g. increased ventricular irritability). Sensitivity reactions may occur in patients with or without history of allergy or bronchial asthma. Hypokalaemia may be avoided or treated in the adult by concurrent use of amiloride hydrochloride, a potassium conserving agent. It may also be avoided by giving potassium chloride or foods with a high potassium content. Diuretic-induced hyponatraemia is usually mild and asymptomatic. Dilutional hyponatraemia may occur in oedematous patients in hot weather; and, except in rare instances when hyponatraemia is life-threatening, appropriate therapy is water restriction rather than administration of salt. Thiazides may decrease serum protein bound iodine levels without signs of thyroid disturbances. Thiazides may decrease urinary calcium excretion, and may also cause intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism. Thiazides should be discontinued before carrying out tests for parathyroid function. When creatinine clearance falls below 30ml/min, thiazide diuretics become ineffective. Uraemia may be precipitated or increased by chlorothiazide. Cumulative effects of the drug may develop in patients with impaired renal function. If increasing uraemia and oliguria occur during treatment of renal disease, Hydrochlorothiazide should be discontinued. Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Hyperuricaemia may occur, or gout may be precipitated, in certain patients receiving thiazide therapy. Thaizide therapy may impair glucose tolerance. Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported. Latent diabetes may become manifest during thiazide administration.
",,"The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalaemia, hypochloraemia, hyponatraemia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalaemia may accentuate cardiac arrhythmias. In the event of overdosage, symptomatic and supportive measures should be employed. If ingestion is recent, emesis should be induced or gastric lavage performed. Dehydration, electrolyte imbalance, hepatic coma and hypotension should be corrected by established methods. If required, give oxygen or artificial respiration for respiratory impairment.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+2053,Hyaluronic Acid,hyaluronic-acid-2053,,,,"This is indicated in-
+
+- Relieve symptoms of knee osteoarthritis (OA)
+- Reduces Joint pain
+- Improves joint mobility
+- Reduces inflammation and swelling
+
",,"Hyaluronic Acid (HA) is a natural organic compound synthesized by fibroblasts and is composed of repeating disaccharide units formed by Glucuronic acid and N-acetylglucosamine acid. The main function of HA, in most biological processes, is to maintain the structural and functional characteristics of tissues. The biosynthesis of HA decreases with age and traumas. Boswellia (containing AKBA at 10%) is useful for the joint function.
This tablet has patented triple-coating technology with two different molecular weights of Hyaluronic acid. The purpose of the different molecular weight is to allow the higher molecular weight to be broken down by the stomach acids and the lower molecular weight to be absorbed through the synovial fluids so to ensures the ingredients will reach the joints unchanged and will not break into the stomach by the acids that are there.
This is made from Hyaluronic acid extracted from Fermented vegetables which is a 100% Vegetarian product. It has all-natural ingredients. This is a new technology. Hyaluronic acid content N-Acetyl Glucosamine and Glucuronic which is a natural polymer. These are the important functions in articular cartilage and synovial fluid which can help in cases of stiffness and mild knee, shoulder, hip, knee, and to improve their mobility. This tablet also consists of AKBA, 3-O-Acetil-11-Keto-β-Boswellico of Boswellia Serrata. It is a powerful anti-inflammatory which helps to reduce the swelling of the joints and improve the joint mobility.
This modified-release triple-layer tablet, based on high molecular weight Hyaluronic Acid and Boswellia containing AKBA at 10%, is developed with a patented process to improve the stability and bioavailability of the Formulation.
","Take one tablet a day, preferably before or during meals, with plenty of water.
",,,,"There have been no known side effects reported so far. But if you have any specific allergies, we recommend you to consult with your doctor before taking this supplement.
",,"Food Supplements should not be understood as a substitute for a varied and balanced diet and a healthy lifestyle. Do not exceed the recommended daily dose. Keep out of reach of children under 3 years of age. It is not to be taken during pregnancy or breastfeeding.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",6
+1056,Human Tetanus Immunoglobulin,human-tetanus-immunoglobulin-1056,https://medex.com.bd/attachments/BXzjiE0JEstWt4UkqcVc0Sl51DbrrD/human-tetanus-immunoglobulin-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Tetanus,"Indications and uses Human Tetanus Immunoglobulin is indicated for -
+
+- Prophylaxis of tetanus following injury in patients whose immunization is incomplete or uncertain.
+- Therapeutically in the treatment of tetanus.
+
+Tetanus immunoglobulin should always be administered
... Read moreIndications and uses Human Tetanus Immunoglobulin is indicated for -
+
+- Prophylaxis of tetanus following injury in patients whose immunization is incomplete or uncertain.
+- Therapeutically in the treatment of tetanus.
+
+Tetanus immunoglobulin should always be administered in conjunction with an active tetanus vaccination unless there are contraindications or confirmations of adequate vaccination.
","Vaccines, Anti-sera & Immunoglobulin
","Human clostridium tetani toxoid immune globulin prevents tetanus toxoid from damaging tissue and producing the symptoms associated with tetanus. The immune globulin binds to tetanus toxiod, interfering with the normal interaction of the toxoid with human tissue. This prevents the toxoid from invading the nervous system and producing painful muscle spasms as well as autonomic dysfunction. The Clostridium tetani bacterium is killed either via antibiotic treatment of the host's immune system and immune globulin-bound toxoid is likely broken down by phagocytic immune cells.
","Post-exposure prophylaxis of tetanus:
+
+- For adults and children single dose of 250 IU should be given. The dose may be increased to 500 IU in case of:
+- Infected wounds where surgically appropriate treatment cannot be achieved within 24 hours
+- Deep or contaminated wounds with tissue damage and reduced oxygen supply, as well as foreign body injury (e.g., bites, stings or shots)
+- Burns, congelations
+- Tissue necrosis
+- Septicaemic abortion
+- Adults weighing more than the average
+
+In case of extensive bums, it is advisable to administer a second injection of 250 IU human tetanus immunoglobulin after the exsudative phase of the burn has subsided (about 36 hours after onset of the bum).
At the same time, 0.5 ml of tetanus vaccine in a different extremity with a separate syringe and complete immunization schedule is required to be administered.
Therapy of clinically manifest tetanus: For adults and children single doses of 3,000 to 6,000 IU (in combination with other appropriate clinical procedures).
","Administrations: Human Tetanus Immunoglobulin should only be administered by intramuscular injection. Human tetanus immunoglobulin should not be administered by intravenously.
Do not use solutions which are cloudy or contain residues (deposits/particles)
Human tetanus immunoglobulin is a ready for use solution and should be administered at body temperature. If comparatively large total volumes are required, it is advisable to administer them in divided doses at different sites
In the presence of a severe coagulation disorder where intramuscular injections are contraindicated, human tetanus immunoglobulin may be given subcutaneously (under the skin) for prophylaxis. Afterwards the injection site should be compressed with a swab. However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route
Co-administration: Immunoglobulin administration may impair the efficacy of live, attenuated virus vaccines such as measles, rubella, mumps and varicella vaccines for a period of up to three months.
After administration of human tetanus immunoglobulin an interval of at least three months should elapse before vaccination with live, attenuated virus vaccines. In the case of measles, this impairment may persist for up to five months. Therefore, patients receiving measles vaccine should have their antibody status checked.
","May reduce the efficacy of live vaccines.
","
+- Known hypersensitivity to any of the components of the product
+- Known hypersensitivity to human immunoglobulins
+- Like any other intramuscular injections, human tetanus immunoglobulin is not advocated for patients with bleeding disorders
+- In patients with a history of immunoglobulin A (IgA) deficiency or severe anaphylactic reactions to plasma products, the risk-benefit ratio must be considered
+
","Adverse reaction following administration of human tetanus immunoglobulin is infrequent and mild, but severe local and systemic reactions have occurred rarely.
+
+- Local reactions at the injection site: Local pain, tenderness or swelling.
+
+In rare cases the following adverse reactions may occur:
+
+- Immune system disorders: Allergic reactions including fall in blood pressure, dyspnoea, cutaneous reactions, in isolated cases reaching as far as anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration of immunoglobulins.
+- Generalized reactions: Chills, fever, headache, malaise, nausea, vomiting, arthralgia and moderate back pain.
+- Heart and vascular disorders: Cardiovascular reactions particularly if the product is inadvertently injected intravascularly.
+
","The safety for use of human tetanus immunoglobulin in human pregnancy has not been established in controlled clinical trials. Long lasting clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the fetus and the neonate are to be expected.
","Should not be administered intravenously
A separate sterile syringe must be used for each patient to prevent the possible transmission of hepatitis B and other infectious diseases.
Should be administered with caution to individuals who have exhibited systemic allergic reactions to immunoglobulin. Epinephrine (0.1~0.5ml, 1:1000) should be available for immediate treatment.
In patients who have severe thrombocytopenia or any coagulation disorder that would contra-indicated intramuscular injection, human tetanus immunoglobulin should be given only if the expected benefits out way the risks.
While administering human tetanus immunoglobulin care should be taken to drawback the plunger of the syringe before injection in order to be certain that the needle is not in blood vessel.
Human tetanus immunoglobulin is prepared from human plasma is pasteurized in its bulk condition to reduce the risk of viruses infections but freedom from the risk of unknown viruses (Parvovirus B-19, etc) cannot be assumed. The infused patient is continuously checked for long time after injection.
",,"Not applicable.
",,,"Keep out of the reach and sight of children. Store at +2 °C to +8 °C. Transportation should also be in designed packs to maintain the product temperature +2 °C to +8 °C. Do not freeze. Discard vaccine if frozen. Protect from light
",12
+1603,"Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18)",human-papillomavirus-quadrivalent-types-6-11-16-and-18-1603,https://medex.com.bd/attachments/XCmZI2ZCvEFqdxfXSPkgsNnLDEyCHg/human-papillomavirus-quadrivalent-types-6-11-16-and-18-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Cervical cancer,"Human Papillomavirus Quadrivalent is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine:
+
+- Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16 and 18.
... Read more
Human Papillomavirus Quadrivalent is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine:
+
+- Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16 and 18.
+- Genital warts (condyloma acuminata) caused by HPV types 6 and 11.
+
+And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:
+
+- Cervical intraepithelial neoplasia (CIN) grade 2/3 and Cervical adenocarcinoma in situ (AIS).
+- Cervical intraepithelial neoplasia (CIN) grade 1.
+- Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3.
+- Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3.
+- Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3.
+
","Vaccines, Anti-sera & Immunoglobulin
","HPV only infects human beings. Animal studies with analogous animal papillomaviruses suggest that the efficacy of L1 VLP vaccines may involve the development of humoral immune responses. Human beings develop a humoral immune response to the vaccine, although the exact mechanism of protection is unknown.
","0.5 ml suspension for intramuscular injection at the following schedule: 0, 2 months, 6 months.
","For intramuscular use only. Shake well before use. Thorough agitation immediately before administration is necessary to maintain suspension of the vaccine. Human Papillomavirus Quadrivalent should not be diluted or mixed with other vaccines. After thorough agitation, Human Papillomavirus Quadrivalent is a white, cloudy liquid. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use the product if particulates are present or if it appears discolored. Human Papillomavirus Quadrivalent should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh. Syncope has been reported following vaccination with Human Papillomavirus Quadrivalent and may result in falling with injury; observation for 15 minutes after administration is recommended.
","Results from clinical studies indicate that Human Papillomavirus Quadrivalent may be administered concomitantly (at a separate injection site) with RECOMBIVAX HB [hepatitis B vaccine (recombinant)]
Results from clinical studies indicate that Human Papillomavirus Quadrivalent may be administered concomitantly (at a separate injection site) with Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] and Adacel [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)]
","Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of Human Papillomavirus Quadrivalent.
","The most common adverse reaction was headache. Common adverse reactions (frequency of at least 1.0% and greater than AAHS control or saline placebo) are fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus, and bruising.
","Pregnancy Category B. Reproduction studies have been performed in female rats at doses equivalent to the recommended human dose and have revealed no evidence of impaired female fertility or harm to the fetus due to Human Papillomavirus Quadrivalent. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human responses, Human Papillomavirus Quadrivalent should be used during pregnancy only if clearly needed. It is not known whether Human Papillomavirus Quadrivalent is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Human Papillomavirus Quadrivalent is administered to a nursing woman.
","Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with Human Papillomavirus Quadrivalent. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position.
","Pediatric Use: Safety and effectiveness have not been established in pediatric patients below 9 years of age.
Geriatric Use: The safety and effectiveness of Human Papillomavirus Quadrivalent have not been evaluated in a geriatric population, defined
as individuals aged 65 years and over.
","There have been reports of administration of higher than recommended doses of Human Papillomavirus Quadrivalent. In general, the adverse event profile reported with overdose was comparable to recommended single doses of Human Papillomavirus Quadrivalent.
",,,"Store refrigerated at 2 to 8°C. Do not freeze. Protect from light. Human Papillomavirus Quadrivalent should be administered as soon as possible after being removed from refrigeration.
",13
+563,Human Papillomavirus Bivalent (Types 16 & 18),human-papillomavirus-bivalent-types-16-18-563,https://medex.com.bd/attachments/zX27YoA4uA1FKBvPHTarokCpjKGSxI/human-papillomavirus-bivalent-types-16-18-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Premalignant cervical lesions and cervical cancer,"Papillomavirus vaccine is indicated in females from 9 years of age onwards for the prevention of persistent infection, premalignant cervical lesions and cervical cancer (squamous cell carcinoma and adenocarcinoma) caused by oncogenic human papillomaviruses (HPV).
","Vaccines, Anti-sera & Immunoglobulin
","Human Papillomavirus (HPV) type 16 and 18 cause about 70% of cervical cancer. HPV bivalent (types 16 and 18) vaccine is a non-infectious vaccine produced by recombinant technology, which contains virus-like particles (VLP) of the major capsid LI protein of oncogenic HPV types 16 and 18. Efficacy of vaccine may be mediated by the production of IgG neutralizing antibodies against the HPV-L1 capsid proteins.
","Adult: Females 10-25 yr (or between 10-45 yr in some countries): 3 doses of 0.5 ml each given at 0,1 and 6 mth, preferably administered into deltoid muscle.
Child: Not recommended for use in girls beiow 9 yr of age.
",,"Immunosuppressive therapies e.g. irradiation, cytotoxic drugs and corticorsteroids may reduce a patient's immune response to the vaccine.
","Known hypersensitivity to any component. Postpone admin in patient suffering from an acute febrile illness.
","Injection site pain, erythema, and inflammation Fatigue, Headache, Myalgia, GI symptoms, Arthralgia
","Pregnancy Category- B. Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester. Unknown whether distributed in breast milk
","Observe patient for 15 min after admin as syncope, sometimes accompanied by transient tonic clonic movements and other seizure-like activity may occur during recovery. Caution in patients with thrombocytopenia or other coagulation disorders as IM admin can cause bleeding. Not to be administered by IV, SC, or intradermal route. Immunocompromised individuals may have diminished immune response to the vaccine. As vaccination will not provide protection against every HPV infection or existing HPV infections, routine cervical screening should still be performed. Not recommended for use during pregnancy; caution in lactation.
",,,,,"Store refrigerated at 2 to 8°C. Do not freeze. Protect from light. Human Papillomavirus Bivalent should be administered as soon as possible after being removed from refrigeration.
",10
+1789,Human Milk based Amino Acid,human-milk-based-amino-acid-1789,,Parenteral nutritional preparations,Parenteral nutrition,"Parenteral nutrition
","Parenteral nutritional preparations
",,,,,,,,,,,,,,2
+1347,Human Menopausal Gonadotrophin,human-menopausal-gonadotrophin-1347,,Female Sex hormones,Stimulation of follicle growth,"Sterility in females with hypo- or normogonadotropic ovarian insufficiency: Stimulation of follicle growth.
Sterility in males with hypo- or normogonadotropic hypogonadism: In combination with HCG to stimulate spermatogenesis.
","Female Sex hormones
","Pharmacodynamic properties: Human Menopausal Gonadotrophin directly affects the ovaries and the testes. Human Menopausal Gonadotrophin has gametotropic and steroidogenic effect. In the ovaries, the FSH-component in Human Menopausal Gonadotrophin induces an increase in the number of growing follicles and stimulates their development. FSH increase the production of estradiol in the granulose cells by aromatizing androgens that originate in the Theca cells under the influence of the LH-component. In the testes, FSH induces the transformation of premature to mature Sertoli cells. It mainly causes the maturation of the seminal canals and development of the spermatozoa. However, a high concentration of androgens within the testes is necessary and can be attained by a prior treatment using HCG.
Pharmacokinetic properties: Human Menopausal Gonadotrophin is not effective when taken orally and is injected i.m. or s.c. Human Menopausal Gonadotrophin's biological effectiveness is mainly due to its FSH and LH content. The pharmacokinetics of Human Menopausal Gonadotrophin following i.m. or s.c. administration were tested product specifically. The maximum serum level of FSH is reached 6-48 hours hours after i.m. injection and 6-36 hours after s.c. injection respectively. After that, the serum level decreases by a half-life of 56 hours (i.m.) and 51 hours (s.c.) respectively. Administered Human Menopausal Gonadotrophin is predominantly discharged renally.
","Sterility in females: The dosage of Human Menopausal Gonadotrophin for the induction of follicle growth in normo-or hypogonadotropic women varies according to the individual. The amount depends on ovarian reaction and should be checked by ultrasound examinations of the ovarian and measuring estradiol levels. If the Human Menopausal Gonadotrophin dosage is too high for the treated individual, multiple uni-and bilateral follicle growth can occur. Human Menopausal Gonadotrophin is administered intramuscularly or subcutaneously and in general, the therapy is begun with a daily dosage corresponding to 75-150 IU FSH. If the ovaries do not respond, the dosage can slowly be increased until a rise in estradiol secretion and follicle growth is evident. Treatment with the same dosage of Human Menopausal Gonadotrophin continues until the pre-ovulatory estradiol serum level is attained. If the level rises too quickly, the dosage should be reduced. To induce ovulation, 5000 or 10000 IU HCG are injected i.m. 1 to 2 days after the last Human Menopausal Gonadotrophin administration.
Note: After a Human Menopausal Gonadotrophin dosage too high for the corresponding individual has been administered the following HCG administration can cause an unintentional hyperstimulation of the ovaries.
Sterility in males: Initially, 2 X 5000 IU HCG a week are administered until a normal testosterone serum level is reached. Then, an additional dose of Human Menopausal Gonadotrophin (3 X 75-150 IU FSH + 75 - 150 IU LH) per week is administered for a few months.
","Method of Administration: Human Menopausal Gonadotrophin is administered by intramuscular or subcutaneous injection.
Selection of patients:
Women:
+
+- Before treatment with Human Menopausal Gonadotrophin is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. This should include a hysterosalpingogram (to rule out uterine and tubal pathology) and documentation of anovulation by means of basal body temperature, serial vaginal smears, examination of cervical mucus, and determination of serum (or urine) progesterone, urinary pregnanediol and endometrial biopsy.
+- Primary ovarian failure should be excluded by the determination of gonadotropin levels.
+- Careful examination should be made to rule out the presence of an early pregnancy.
+- Patients in late reproductive life have a greater predilection to endometrial carcinoma as well as a higher incidence of anovulatory disorders. Cervical dilation and curettage should always be done for abnormal uterine bleeding or other signs of endometrial abnormalities.
+
+Men:
+
+- Patient selection should be made based on a documented lack of pituitary function. Prior to hormonal therapy, these patients will have low testosterone levels and low or absent gonadotropin levels. Patients with primary hypogonadotropic hypogonadism will have a subnormal development of masculinization, and those with secondary hypogonadotropic hypogonadism will have decreased masculinization.
+
","Interaction with other medicaments are unknown. Human Menopausal Gonadotrophin can be injected together with HCG when treating infertile males.
","In females:
+
+- Pregnancy,
+- Enlargement of the ovaries or cysts that is not caused by polycystic ovarian syndrome,
+- Gynecological bleeding whose cause is unknown,
+- Tumors in the uterus, ovaries and breasts,
+- Prior hypersensitivity to Menotrophins or to any of the excipients,
+- A high FSH level indicating primary ovarian failure,
+- The presence of uncontrolled thyroid and adrenal dysfunction,
+- The presence of any cause of infertility other than anovulation.
+
+In males:
+
+- Carcinoma of the prostate.
+- Tumors in the tests,
+- Normal gonadotrophin levels indicating normal pituitary function,
+- Elevated gonadotrophin levels indicating primary testicular failure,
+- Infertility disorders other than hypogonadotropic hypogonadism.
+
+The following conditions should be properly treated before Human Menopausal Gonadotrophin therapy is begun:
+
+- Dysfunctions of the thyroid gland and cortex of the suprarenal gland,
+- Hyperprolactinemia,
+- Tumors in the pituitary or in the hypothalamic glands.
+
",,"There is no indication for Human Menopausal Gonadotrophin to be used during pregnancy and lactation period
","In pregnancies occurring after induction of ovulation with gonadotropic preparations, there is an increased risk of miscarriage, multiples and ectopic pregnancies. Human Menopausal Gonadotrophin should not be administered to induce ovulation in females whose ovaries have unintentionally been hyper-stimulated. When treating sterile women, ovarian activity should be checked (ultrasound and estradiol levels in serum respectively) prior to HMG administration. During treatment, these tests should be carried out every one to two days until stimulation occurs. Ovarian reaction can also be measured using a cervix index. Close supervision is imperative during treatment. Treatment should be immediately discontinued if unintentional hyper-stimulation occurs. This warning is particularly important with respect to patients with polycystic ovarian disease. The severe form of ovarian hyper-stimulation syndrome may be life-threatening and is characterized by large ovarian cysts (prone to rupture), ascites, very often hydrothorax and occasionally thromboembolic phenomena.
",,"Treatment with Human Menopausal Gonadotrophin can lead to hyper-stimulation of the ovaries. This, however, mostly becomes clinically relevant only after HCG has been administered to induce ovulation (please see Undesirable effects paragraph). No therapy is necessary when a slight hyper-stimulation is present (Level I) accompanied by a slight enlargement of the ovaries (over size 5-7 cm), excessive steroid secretion, and abdominal pain. The patient should be informed, however, and carefully watched. Clinical supervision and symptomatic treatment, and perhaps an intravenous volume replacement in case of high hemoglobin concentration, is necessary if hyper-stimulation (Level II) with ovarian cysts (ovary size 8-10 cm) is present, accompanied by abdominal symptoms, nausea, and vomiting. Hospitalization is imperative when serious hyper-stimulation (Level III) with large ovarian cysts (ovary size more than 10 cm) is present accompanied by ascites, hydrothorax, enlarged abdomen, abdominal pain, dyspnea, salt retention, hemoglobin concentration, increased blood viscosity, and platelet aggregation with the danger of thromboembolisms. Undesirable effects Sensitivity to Human Menopausal Gonadotrophin - Febrile reaction which may be accompanied by chills, musculoskeletal aches or pain, malaise and fatigue have occurred after the administration of Human Menopausal Gonadotrophin. It is not clear whether or not these were pyrogenic responses or possible allergic reactions. In addition, reports of ""flu-like symptoms"" including fever, Chills, musculoskeletal aches, joint pains, nausea, headache and malaise have been received - Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal cramps, bloating). - Pain, rash, swelling and/or irritation at the site of injection. - Body rashes. - Dizziness, tachycardia, dyspnea, tachypnea. The following medical events have been reported subsequent to pregnancies resulting from Human Menopausal Gonadotrophin therapy: - Ectopic pregnancy. - Congenital abnormalities
",,,"Store at 2°C to 8°C, Do not freeze. Store below 25°C for single period of not more than 3 months. Protect from light and keep in dry place. The reconstituted solution of the vial should be used immediately after piercing of the rubber stopper. Discard any remaining solution.
",11
+548,Human Immunoglobulin-G [IgG],human-immunoglobulin-g-igg-548,https://medex.com.bd/attachments/6YDzufH35cIo2BpCJJrxCHda6etOlr/human-immunoglobulin-g-igg-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Primary antibodies deficiency,"Human immunoglobulin-G (IgG) is indicated in:
+
+- Treatment of primary immunodeficiency
+- For combined therapy with antibiotics in severe bacterial or viral infections
+- A-/Hypogammaglobulinemia
+- Idiopathic Thrombocytopenic Purpura
+- Guillain-Barre Syndrome
+- Kawasaki Syndrome
+
","Vaccines, Anti-sera & Immunoglobulin
",,"Neonates and infants: 5 ml (250 mg)/kg body weight daily on 3 consecutive days. Further infusion may be required depending on the clinical course.
Children and adults:
+
+- For combined therapy with antibiotics in severe bacterial or viral infections and A-/Hypogammaglobulinemia: The usual dosage for adults and children is 2500-5000 mg and 50-150 mg/kg respectively (as a single dose) by intravenous drip infusion or direct intravenous infusion. In case of intravenous injection, it should be injected very slowly.
+- For Idiopathic Thrombocytopenic Purpura: The usual dose is 200-400 mg/kg daily given for 5 consecutive days. The additional doses are discontinued if an adequate response does not occur.
+
+
For Guillain-Barre Syndrome: The usual dosage is 400 mg/kg daily given for 5 consecutive days.
For Kawasaki Syndrome: The usual dosage is 400 mg/kg daily given for 5 consecutive days (approximately) or 2000 mg daily by intravenous drip infusion. It is recommended that the administration start within 7 days from the onset of Kawasaki Syndrome.
","The human normal immunoglobulin is for intravenous use only. For intravenous injection, it should be injected very slowly. The product should be warmed to room or body temperature before use. The human normal immunoglobulin should be infused intravenously at the following rates:
0.01~0.02 ml/kg/min for first 30 minutes and then infusion rate can be gradually increased maximum 0.06 ml/kg/min, if no abnormal sign appears from patients. This infusion can be recalculated by hourly basis; it is 0.6~1.2 ml/kg/hr and 3.6 ml/kg/hr (maximum).
General cautions:
+
+- The human normal immunoglobulin is for intravenous use only.
+- When a needle is inserted through the rubber stopper, the needle should be inserted vertically and slowly. If a needle is inserted in a tilted or twisted direction, rubber fragments may be mixed with medicinal product. If there are any rubber fragments, discard the product.
+- The vial should be inspected for visible particulate matter and color prior to administration. Do not use the vial if particles are detected. Do not use if turbid.
+- Several vials may be pooled into an empty sterile solution container by using aseptic technique, if large doses are to be administered.
+- The human normal immunoglobulin cannot be diluted with intravenous fluids. Other medications cannot be injected into the intravenous tubing being used for the human normal immunoglobulin. In case of idiopathic Thrombocytopenic Purpura for children, spontaneous remission should be considered.
+- Additional administration to patients with Kawasaki Syndrome should be conducted when the effectiveness of immunoglobulin is insufficient (e.g. symptomatic remission) or additional administration is clearly necessary.(Safety and efficacy for additional administration has not been established)
+- Patients should be aware of the risk and discuss with their healthcare professionals and contact them if any signs or symptoms of thrombosis during or after receiving this product develop.
+- Healthcare professionals should be aware of the risk for thrombosis with human normal immunoglobulin products and discuss with their patients the risk of thrombosis associated with this product.
+
+There is a possibility that live vaccines (measles, mumps, rubella and varicella vaccine etc.) do not work for the patients who were treated with human normal immunoglobulin. Therefore vaccination should be delayed for 3 months after administration. If human normal immunoglobulin is administered within 14 days after vaccination, re-vaccination should be taken after more than 3 months post administration.
After a large bolus (more than 200 mg/kg) administration for the ITP and Kawasaki disease, use of live vaccines should be delayed more than 6 months. In case of low risk of measles infection, measles vaccination can be delayed more than 11 months.
","May interfere with the immune response to live measles vaccine, live mumps vaccine, live rubella vaccine and live varicella vaccine, therefore these vaccines should be given at least 3 wk before or 3 mth after the admin of the immunoglobulins.
","Contraindicated in patients who have had a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of human normal immunoglobulin.
","
+- Symptoms of shock may occur. If dyspnea, wheeze, chest pain, hypotension or weak pulse are watched, administration should be discontinued and 0.1-0.5 ml epinephrine (1:1000) or the administration of cortisone should be considered.
+- Rapid administration can cause hypotension.
+- Liver function disorders or jaundice accompanying and increase in ALT or AST may occur. Caution should be taken and proper treatment should be followed if needed.
+- Renal failure may occur with the use of human normal immunoglobulin. If dehydration, hypouresis, increase of creatinine or increase of BUN etc is observed, administration should be discontinued and proper treatment should be taken.
+- Aseptic meningitis from a large volume of IVIG administration may occur.
+- Decrease in platelets may occur. Other possible undesirable effects include drowsiness, chill, chest pain, abdominal pain, gluteal pain and anxiety etc.
+
","Safety for a pregnant woman has not been established. The possibility of parvovirus B-19 infection cannot be excluded from the administration of human normal immunoglobulin. In case of parvovirus B-19 infection, fetal disturbances (Abortion, Hydrops fetalis, fetal death) may occur. Human normal immunoglobulin should be given to a pregnant woman only if the expected benefit justifies the possible risk. Use of this product has not been evaluated in nursing mothers.
","Human normal immunoglobulin, manufactured from human plasma, has the potential to transmit hepatitis viruses or other viruses. Accordingly, patients with hemophilia or immunodeficiency are recommended to be appropriately vaccinated (Hepatitis A vaccine, etc.), and the attending physician should monitor patients regularly to check any sign of virus infection.
Thrombosis may occur regardless of the route of administration and in the absence of known risk factors (advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity and cardiovascular risk factors). For patients at risk of thrombosis, administer at the minimum concentration possible and at the minimum rate of infusion practicable.
Severe hypersensitivity reactions and anaphylactic reactions with a fall in blood pressure may occur. Patients with antibodies to IgA have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.
Patients with renal disorder (Renal function may deteriorate), Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis and death have been reported in patients receiving IVIG. It should be ensured that patients are not volume-depleted before administration of the IVIG. For patients judged to be at risk for developing renal dysfunction, including patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs, IVIG should be administered at the minimum dose and rate of infusion practicable.
Patients with hemolytic anemia or anemia from blood loss (Human parvovirus B19 infection may occur. In case of infection, continuous anemia may occur.) Patients with cerebrovascular and cardiovascular disorders or case history thereof for example, (Elderly patients with ischemic disease, cardiovascular disorder, cerebrovascular disorders or case of history thereof: a large bolus administration can cause thrombus or embolism such as cerebral infarction, a myocardial infarction, etc, due to blood viscosity increase.)
Patients with high risk of thrombus or embolism (Thrombus or embolism may occur due to an increase of blood viscosity due to large bolus administration.)
Patients with low heart function.
Aseptic Meningitis Syndrome (AMS) has been reported to occur following high dose (e.g. over 1.0 g per kg body weight) of IVIG treatment or rapid infusion of IVIG. The symptoms of AMS usually begin within several hours to 2 days following IVIG treatment. Discontinuation of IVIG treatment has resulted in remission of AMS within several days without sequelae. AMS is characterized by the following signs and symptoms: severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea and vomiting.
Patients should take caution with IgA deficiency. (IVIG may cause anaphylaxis to patients who have anti-IgA)
Human normal immunoglobulin may contain blood group antibodies that may act as hemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin test result and hemolysis. Delayed hemolytic anemia can develop subsequent to IVIG therapy due to enhanced red blood cell sequestration and acute hemolysis, consistent with intravascular hemolysis, has been reported.
Non-cardiogenic pulmonary edema has been reported in patients following IVIG treatment. Transfusion-related acute lung injury is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Symptoms typically appear within 1 to 6 hours after transfusion.
",,,,,"Store and transport at 2°C to 8°C. Protect from light. Do not freeze. Keep out of the reach and sight of children
",10
+547,Human Chorionic Gonadotrophin,human-chorionic-gonadotrophin-547,https://medex.com.bd/attachments/LO2WGBAdJYHt0IXy5K9wQhDOR7M6Mf/human-chorionic-gonadotrophin-prescribing-information,Female Sex hormones,Male Hypogonadotropic Hypogonadism,"In the female:
+
+- Ovulation induction in infertility due to anovulation or impaired follicle-ripening.
+- Preparation of follicles for puncture in controlled ovarian hyperstimulation programs (ART).
+- Luteal phase support.
+- Threatened and habitual abortion
+
+In
... Read moreIn the female:
+
+- Ovulation induction in infertility due to anovulation or impaired follicle-ripening.
+- Preparation of follicles for puncture in controlled ovarian hyperstimulation programs (ART).
+- Luteal phase support.
+- Threatened and habitual abortion
+
+In the male:
+
+- Hypogonadotropic hypogonadism (also cases of idiopathic dysspermias have shown a positive response to gonadotropins).
+- Delayed puberty associated with insufficient gonadotropic pituitary function.
+- Cryptorchidism, (not due to anatomical obstruction)
+- Used to treat oligospermia
+
","Female Sex hormones
","Pharmacodynamic Properties: Highly Purified Human Chorionic Gonadotrophin has LH activity. LH is indispensable in normal female and male gamete growth and maturation, and gonadal steroid production.
+
+- In the female: Human Chorionic Gonadotrophin is given as a substitute for the endogenous mid-cycle LH surge to induce the final phase of follicular maturation, leading to ovulation. Human Chorionic Gonadotrophin is also given as a substitute for endogenous LH during the luteal phase.
+- In the male: Human Chorionic Gonadotrophin is given to stimulate Leydig cells to promote the production of testosterone.
+
+
Pharmacokinetic Properties: Maximal Human Chorionic Gonadotrophin plasma levels will be reached approximately six hours after a single injection of Human Chorionic Gonadotrophin . Human Chorionic Gonadotrophin is for approximately 80 percent metabolized, predominantly in the kidneys. Following intramuscular injection (IM) the apparent elimination half-life of Human Chorionic Gonadotrophin is about 2 days. On basis of the recommended dose regimens and elimination half-life, accumulation does not occur.
","After addition of the solvent to the freeze-dried substance, the reconstituted Human Menopausal Gonadotrophin solution should be slowly administered intramuscularly.
In the female: Ovulation induction and preparation of follicles for puncture: Usually, one injection of 5000- 10000IU Human Menopausal Gonadotrophin to complete treatment with an FSH-containing preparation.
Luteal phase support: Two repeat injections of 2500 to 5000IU. Each may be given within nine days following ovulation or embryo transfer (for example on day 3, 6 and 9 after ovulation induction).
Threatened & habitual abortion: 5000IU Human Menopausal Gonadotrophin will be given as deep intramuscular injection twice weekly from the time of diagnosis (all before the 7th week of gestation)
In the male: Hypogonadotropic hypogonadism: 2500 to 5000 IU Human Menopausal Gonadotrophin, two times per week. If the main complaint is sterility, additional doses of an FSH-containing (50IU FSH) are to be administered daily or two to three times a week. This treatment should be continued for at least three months before any improvement in spermatogenesis can be expected. During this treatment testosterone replacement therapy should be suspended. Once achieved, the improvement may in some cases be maintained by Human Menopausal Gonadotrophin alone.
",,"No interactions of clinical relevance are known.
","Known or suspected androgen-dependent tumours, such as prostatic carcinoma or breast carcinoma in the male.
","Allergic reactions have occasionally been reported with the use of urinary gonadotrophin preparations. These mostly involve local reactions such as pain and rash at the injection site, and generalized reactions such as rash and fever.
In the female: Unwanted ovarian hyperstimulation syndrome. Which is Characteristic symptoms of unwanted ovarian hyperstimulation and the ovarian hyperstimulation syndrome are included under 'Special warnings and special precautions for use'.
In the Male: Water and sodium retention is occasionally seen after administration of high dosages; this is regarded as a result of excessive androgen production. Treatment with Human Chorionic Gonadotrophin leads to increased androgen production.
Therefore: Patients with latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine (or a history of these conditions) should be kept under close medical supervision, since aggravation or recurrence may occasionally be induced as a result of increased androgen production. Human Chorionic Gonadotrophin should be used cautiously in prepubertal boys to avoid premature epiphyseal closure or precocious sexual development. Skeletal maturation should be monitored regularly.
","Pregnancy Category X. Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
Use in lactation: It must not be used during lactation
","In pregnancies occurring after induction of ovulation with gonadotropic preparations, there is an increased risk of multiplets birth. Unwanted ovarianhyperstimulation: In patients treated for infertility due to anovulation or impaired follicular ripening, the prior administration of an FSH containing preparation may lead to unwanted ovarian hyperstimulation. Therefore ultrasonic assessment of follicular development and determinations nations of estrogen levels should be performed prior to FSH-treatment and at regular intervals during FSH-treatment. Estrogen levels may rise very rapidly, e.g. more than a daily doubling for two or three consecutive days, and possibly reach excessively high values. If this unwanted ovarian hyperstimulation occurs (i.e. not as part of a treatment preparing for IVF/ET or GIFT/ZIFT), the administration of the FSH-containing preparation should be discontinued immediately. In that case Human Chorionic Gonadotrophin must not be given, because the administration of an LH-active gonadotrophin at this stage may induce, in addition to multiple ovulations, the ovarian hyperstimulation syndrome. This warning is particularly important with respect to patients with polycystic ovarian disease. Clinical symptoms of mild ovarian hyperstimulation syndrome are gastro-intestinal problems (pain, nausea, diarrhoea), painful breasts, and mild to moderate enlargement of ovaries and ovarian cysts. In rare cases severe ovarian hyperstimulation syndrome occurs, which may be life-threatening. This is characterized by large ovarian cysts (prone to rupture), ascites, often hydrothorax and occasionally
","Pediatric Use: Induction of androgen secretion by HCG may induce precocious puberty in pediatric patients treated for cryptorchidism. Therapy should be discontinued if signs of precocious puberty occur.
Geriatric Use: Clinical studies of Chorionic gonadotropin for injection did not include subjects aged 65 and over.
","The acute toxicity of urinary gonadotropin preparations has been shown to be very low. There are no symptoms of an acute parenteral overdose known in humans.
",,,"There are two options:
+
+- Store at 2°C-8°C (in refrigerator). Do not freeze.
+- Store below 25°C for a single period of not more than 3 months.
+
+Protect from light & keep in dry place.
",12
+546,Human Anti-D Immunoglobulins,human-anti-d-immunoglobulins-546,https://medex.com.bd/attachments/9olBUDB7kcO11TKtwuyW3NyXyCQnjT/human-anti-d-immunoglobulins-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Rhesus disease,"Pregnancy and Other Obstetrical Conditions in Rh-Negative Women, Unless the Father or Baby are Conclusively Rh Negative:
+
+- Pregnancy/delivery of an Rh-positive baby irrespective of the ABO groups of the mother and baby
+- Abortion/threatened abortion at any stage of gestation
... Read more
Pregnancy and Other Obstetrical Conditions in Rh-Negative Women, Unless the Father or Baby are Conclusively Rh Negative:
+
+- Pregnancy/delivery of an Rh-positive baby irrespective of the ABO groups of the mother and baby
+- Abortion/threatened abortion at any stage of gestation
+- Ectopic pregnancy
+- Antepartum fetal-maternal hemorrhage (suspected or proven) resulting from antepartum hemorrhage (e.g., placenta previa), amniocentesis, chorionic villussampling, percutaneous umbilical blood sampling, other obstetrical manipulative procedure (e.g., version) or abdominal trauma
+- Transfusion of Rh incompatible blood or blood products
+
+
Transfusion: Prevention of Rh immunization in any Rh-negative person after incompatible transfusion of Rh-positive blood or blood products (e.g., red blood cells, plateletconcentrates, granulocyte concentrates)
","Vaccines, Anti-sera & Immunoglobulin
","Anti-D immunoglobulin prevents a rhesus-negative mother from actively forming antibodies to foetal rhesus-positive RBCs that may pass into the maternal circulation during childbirth, abortion, or certain other sensitising events. It is also used in idiopathic thrombocytopenic purpura to prevent excessive bleeding.
","One dose 250 mcg should be given IM immediately or as soon as possible after delivery, or abortion of a Rh-positive child, preferably within 48 hours, but not later than 72 hours post-partum.
Following any potentially sensitizing episode (e.g stillbirth, amniocentesis) up to 20 weeks of gestation 125 mcg per episode (after 20 weeks of gestation, 250 mcg) immediately or within 72 hours.
For antenatal prophylaxis 250 mcg should be given in week 28 & also week 34 of pregnancy. The injection must only be given deep intramuscularly. Do not inject intravenously.
",,"Live vaccines should only be admin at least 3 mth after the last dose of immunoglobulin admin.
","Splenectomised or rhesus-negative patients, in whom the resultant haemolysis may exacerbate pre-existing anaemia. Hypersensitivity.
","Hypersensitivity reactions such as hives, wheezing, urticaria, Pain and tenderness at inj site. Fever, chills, nausea, facial flushing, headache.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","For postpartum usage, it is to be used only for maternal admin. Not for rhesus-positive individuals. Patients should be observed for 20 minutes after admin.
",,,,,"Should be stored in cool and dry place.
",10
+544,Homatropine Hydrobromide,homatropine-hydrobromide-544,https://medex.com.bd/attachments/Fp9zejWCNH6s6pHdbmYAi8ASqB2fj6/homatropine-hydrobromide-prescribing-information,Mydriatic and Cycloplegic agents,Uveitis,"Homatropine Hydrobromide sterile Eye Drops is indicated for use as a mydriatic and cycloplegic agent.
","Mydriatic and Cycloplegic agents
","Homatropine, a tertiary amine antimuscarinic, produces dilation and loss of accommodation by blocking the response of iris sphincter muscle and the accommodative ciliary muscle to cholinergic stimulation.
","Mydriasis and cycloplegia for refraction:
+
+- Adult: Instill 1 or 2 drops of 2% solution, or 1 drop of 5% solution immediately before the procedure, repeat at 5-10 minute intervals if necessary.
+- Child: Instill 1 drop of 2% soln immediately before the procedure, repeat at 10-min intervals if necessary.
+
+Uveitis:
+
+- Adult: Instill 1-2 drops of 2% or 5% solution bid-tid up to every 3-4 hr as needed.
+- Child: 3 mth- 2 yr: instill 1 drop of 0.5% soln once daily or on alternate days. >2 yr: instill 1 drop of 1% or 2% soln bid.
+
",,"Effects may be increased by drugs with antimuscarinic effect such as; some antihistamines; phenothiazines; antipsychotics; TCAs; MAOIs or parasympathomimetics.
","Contraindicated in patients with closed-angle glaucoma or with a narrow angle between the iris and the cornea.
","Hypersensitivity may occur as conjunctivitis.
","Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Matropin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether Homatropine is excreted in human milk. Caution should be exercised when Matropin is administered to a nursing mother.
","Should be used with caution in patients with prostatic enlargement and in patients suffering from paralytic ileus or pyloric stenosis.
","Use in children: Should not be used in children below the age of 3 months
","Ataxia, incoherent speech, restlessness, hallucinations, disorientation, failure to recognize people and tachycardia. Psychotic reactions and behavioural disturbances (in children). SC/IM/IV Physostigmine salicylate 1-2 mg to control central and peripheral effects. Small doses of short-acting barbiturate eg. thiopentone sodium 100 mg to control excitement.
",,,,11
+593,Ibuprofen,ibuprofen-593,https://medex.com.bd/attachments/lKVQd6S29Kl8HFiYrWJa7gJwCvNPJp/ibuprofen-tablets-prescribing-information,Drugs for Osteoarthritis,Yellow fever infection,"Ibuprofen is indicated in the following indications-
+
+- Rheumatoid arthritis
+- Osteoarthritis
+- Gouty arthritis
+- Juvenile polyarthritis
+- Ankylosing spondylitis
+- Synovitis
+- Low back pain
+- Dysmenorrhoea
+- Fever
+- Migraine
+- Soft tissue injuries
+- Pain & Inflammation in dental and musculoskeletal origin.
+
","Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Ibuprofen has a high level of anti-inflammatory, anti-pyretic, and analgesic activity. The analgesic effects of Ibuprofen are due to both a peripheral and a central effect. Ibuprofen is a potent inhibitor of the enzyme cyclooxygenase, which thus results in a marked reduction in prostaglandin synthesis. Ibuprofen also inhibits the synthesis of some lipo-oxygenase products. Ibuprofen thus quickly relieves pain and stiffness, reduces swelling, and improves the movement of different joints of arthritis sufferers.
","Adults: The dose is initially, 400 mg 3 times daily. A dose of 2400 mg daily should not be exceeded.
Children:
+
+- 3-6 months (body-weight over 5 kg): ½ tsp (2.5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
+- 6 months-1 year: ½ tsp (2.5 ml) 3-4 times daily; max. 30 mg/kg daily in 3-4 divided doses.
+- 1-4 years: 1 tsp (5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
+- 4-7 years: 1½ tsp (7.5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
+- 7-10 years: 2 tsp (10 ml) 3 times daily; upto 30 mg/kg (max. 2.4 gm) daily in 3-4 divided doses.
+- 10-12 years: 3 tsp (15 ml) 3 times daily; upto 30 mg/kg (max. 2.4 gm) daily in 3-4 divided doses.
+
+
children weighing less than 5 kg: Not recommended for children weighing less than 5 kg.
In juvenile rheumatoid arthritis: up to 30-40 mg/kg of body weight daily in 3-4 divided doses may be taken or as directed by the physician.
",,,"Ibuprofen is contraindicated in patients who have shown the previous hypersensitivity to Ibuprofen, and in patients with severe or active peptic ulceration.
","Upset stomach, vomiting, heartburn, nausea may occur.
","Adverse effects of Ibuprofen on the developing fetus cannot be fully excluded. Ibuprofen should not be used during pregnancy and for nursing mothers unless the potential benefits to the mothers outweigh the potential risks.
","Ibuprofen should be used with caution and the lowest effective doses should be given if there is a history of gastrointestinal hemorrhage or ulcer. Patients on long-term therapy with Ibuprofen require ocular monitoring at regular intervals, as changes in ocular function have been reported. Patients with systemic lupus erythematosus are more likely than others to develop hypersensitivity to Ibuprofen. Ibuprofen should be prescribed with caution in patients with asthma and in patients with a history of hypersensitivity to other nonsteroidal anti-inflammatory agents.
",,,,,"Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.
",9
+1382,Ibrutinib,ibrutinib-1382,https://medex.com.bd/attachments/YrZq34PKgp1Y8nAGYb0pMipLs1Hutj/ibrutinib-prescribing-information,Targeted Cancer Therapy,Waldenström's macroglobulinemia,"Mantle Cell Lymphoma: Ibrutinib is indicated for the treatment of patients with Mantle Cell Lymphoma (MCL) who have received at least one prior therapy.
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Ibrutinib is indicated for the treatment of patients ... Read more
Mantle Cell Lymphoma: Ibrutinib is indicated for the treatment of patients with Mantle Cell Lymphoma (MCL) who have received at least one prior therapy.
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Ibrutinib is indicated for the treatment of patients with chronic lymphocytic leukemia. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma with 17p deletion Ibrutinib is indicated for the treatment of patients with chronic lymphocytic leukemia.
Waldenstrom Macroglobulinemia (WM): Ibrutinib is indicated for the treatment of patients with Waldenstrom Macroglobulinemia (WM).
Marginal Zone Lymphoma: Ibrutinib is indicated for the reatment of patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD 20-based therapy.
","Targeted Cancer Therapy
","Ibrutinib is a small-molecule inhibitor of BTK. Ibrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signaling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. BTK’s role in signaling through the B-cell surface receptors results in activation of pathways necessary for B-cell trafficking, chemotaxis, and adhesion. Nonclinical studies show that ibrutinib inhibits malignant B-cell proliferation and survival in vivo as well as cell migration and substrate adhesion in vitro.
","Mantle Cell Lymphoma and Marginal Zone Lymphoma: The recommended dose of Ibrutinib for MCL and MZL is 560 mg (four 140 mg capsules) orally once daily until disease progression or unacceptable toxicity.
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Waldenstrom Macroglobulinemia (WM): The recommended dose of Ibrutinib for CLL/SLL and WM is 420 mg (three 140 mg capsules) orally once daily until disease progression or unacceptable toxicity. The recommended dose of Ibrutinib for CLL/SLL when used in combination with bendamustine and rituximab (administered every 28 days for up to 6 cycles) is 420 mg (three 140 mg capsules) orally once daily until disease progression or unacceptable toxicity.
","Administer Ibrutinib orally once daily at approximately the same time each day.
Swallow the capsules whole with water. Do not open, break, or chew the capsules.
","CYP3A Inhibitors: Co-administration with strong and moderate CYP3A inhibitors should be avoided. If a moderate CYP3A inhibitor must be used, Ibrutinib dose should be reduced
CYP3A Inducers: Co-administration with strong CYP3A inducers should be avoided
","Hypersensitivity to the active substance or to any of the excipients.
","The following adverse reactions are discussed in more detail in other sections of the labeling: Hemorrhage, Infections, Cytopenias, Atrial Fibrillation, Hypertension, Second Primary Malignancies and Tumor Lysis Syndrome. Additional Important Adverse Reactions: Diarrhea, Visual Disturbance.
","Pregnancy: Ibrutinib, a kinase inhibitor, can cause fetal harm based on findings from animal studies. In animal reproduction studies, administration of Ibrutinib to pregnant rats and rabbits during the period of organogenesis at exposures up to 2-20 times the clinical doses of 420-560 mg daily produced embryofetal toxicity including malformations. If Ibrutinib is used during pregnancy or if the patient becomes pregnant while taking Ibrutinib, the patient should be apprised of the potential hazard to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
Lactation: There is no information regarding the presence of Ibrutinib or its metabolites in human milk, the effects on the breast fed infant, or the effects on milk production.
",,"Pediatric Use: The safety and effectiveness of Ibrutinib in pediatric patients has not been established.
Geriatric Use: Of the 905 patients in clinical studies of Ibrutinib, 62% were ≥ 65 years of age, while 21% were ≥75 years of age. No overall differences in effectiveness were observed between younger and older patients. Anemia (all grades) and Grade 3 or higher pneumonia occurred more frequently among older patients treated with Ibrutinib.
Hepatic Impairment: Ibrutinib is metabolized in the liver. In a hepatic impairment study, data showed an increase in Ibrutinib exposure. The safety of Ibrutinib has not been evaluated in cancer patients with mild to severe hepatic impairment by Child-Pugh criteria. Monitor patients for signs of Ibrutinib toxicity and follow dose modification guidance as needed. It is not recommended to administer Ibrutinib to patients with moderate or severe hepatic impairment.
","There is no specific experience in the management of Ibrutinib over dose in patients. One healthy subject experienced reversible Grade 4 hepatic enzyme increases (AST and ALT) after a dose of 1680 mg. Closely monitor patients who ingest more than the recommended dosage and provide appropriate supportive treatment.
",,,"Store in a dry place below 30°C, protect from light. Keep out of the reach of children.
",12
+1571,Ibandronic Acid + Calcium Carbonate + Vitamin D3,ibandronic-acid-calcium-carbonate-vitamin-d3-1571,,Bisphosphonate preparations,Osteoporosis,"This kit is indicated for the treatment and prevention of Osteoporosis. It increases Bone Mineral Density (BMD) and reduces the incidence of vertebral fractures.
","Bisphosphonate preparations
","Ibandronic Acid (Ibandronate Sodium Monohydrate) is a nitrogen- containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The action of Ibandronate on bone tissue is based on its affinity for hydroxyapatite, which is part of the mineral matrix of bone. Ibandronate inhibits osteoclast activity and reduces bone resorption and turnover. In postmenopausal women, it reduces the elevated rate of bone turnover, leading to, on average, a net gain in bone mass.
The combination of Coral Calcium and Colecalciferol is composed of Calcium Carbonate with small amounts of Magnesium and other Trace minerals. Coral Calcium ensures better absorption than Calcium of other Calcium Carbonate origin due to its chemical structure that is very similar to the composition of human bone Calcium Carbonate. Vitamin-D aids in the absorption of Calcium from GI tract and helps to maintain Calcium balance in the body.
","One tablet of Ibandronic Acid 150 mg once monthly on the same date of each month is recommended. To maximize clinical benefit of Ibandronic acid, two tablets of Calcium 500 mg and Vitamin D3 200 IU per day are usually recommended in divided dosage or as directed by the physician.
Day 1: Take the Ibandronic Acid tablet on an empty stomach at least 60 minutes before the first food or drink (other than water) of the day or before taking any oral medication or supplementation including Calcium, Antacid and/or Vitamins
+
+- Swallow tablet whole with a glass of plain water while standing or sitting in an upright position
+- Avoid lying down for 60 minutes
+- Do not chew or suck the tablet
+
+
Day 2-31: One tablet of Calcium and Vitamin D should be taken at the morning and at the evening after meal
+
+- Tablets should be taken in order as directed on the blister strip for ease of dose tracking.
+
+
Pediatric patient: Safety and effectiveness in pediatric patients have not been established.
",,"Ibandronic Acid: Products containing calcium and other multivalent cations (such as aluminum, magnesium, iron), including milk, food, and antacids are likely to interfere with absorption of Ibandronate. It is also found to interact with H2 blockers such as Ranitidine in several clinical trials..
Calcium (Coral) and Vitamin-D: Oral Calcium can reduce the absorption of tetracycline & fluoride preparations and minimum 3 hours’ time should be allowed between ingestion of these medications. Thiazide diuretics reduce the renal excretion of Calcium. Phenytoin, barbiturates, glucocorticoids may induce metabolism of Vitamin D. Concomitant intake of certain foods like spinach, cereals, milk and its derivatives may reduce the intestinal uptake of Calcium.
","Ibandronic Acid is contraindicated in conditions like: abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia. Inability to stand or sit upright for at least 60 minutes, Hypocalcemia, known hypersensitivity to Ibandronic Acid.
Calcium & Vitamin D3: Hypersensitivity to any of the component of this preparation. It is also contraindicated in case of hypercalcemia, hyperparathyroidism, hypercalciuria, nephrolithiasis, severe renal insufficiencies, concomitant Digoxin therapy (requires careful monitoring of serum calcium level), renal calculi and Zollinger Ellison syndrome.
","Ibandronic Acid: Common side effects include Hypertension, Dyspepsia, Nausea, Diarrhea, Abdominal Pain, Arthralgia, Back Pain, Localized Osteoarthritis, Myalgia, Muscle Cramp, Influenza, Nasopharyngitis, Bronchitis, Urinary Tract Infection, Upper Respiratory Tract Infection, Headache, Dizziness, Skin rash, Insomnia etc.
Calcium & Vitamin D3: Most common side effects are flatulence, diarrhea, constipation, upper GI discomfort etc. Hypercalciuria and hypercalcemia due to prolong use has rarely been reported.
","Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. This kit should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.
Nursing mother: It is not known whether this kit is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this kit is administered to a nursing woman.
","Ibandronic Acid:
+
+- Upper Gastrointestinal Adverse Reactions: Ibandronic acid like other bisphosphonates administered orally may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects, caution should be used when Ibandronic acid is given to patients with active upper gastrointestinal problems (such as known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers).
+- Hypocalcaemia and Mineral Metabolism: Treat hypocalcemia and other disturbances of bone and mineral metabolism before starting therapy.
+- Musculoskeletal Pain: Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking Ibandronic acid and other bisphosphonates.
+- Jaw Osteonecrosis: Osteonecrosis, primarily in the jaw, has been reported in patients treated with bisphosphonates. Most cases have been in cancer patients undergoing dental procedures, but some have occurred in patients with postmenopausal osteoporosis or other diagnoses.
+
+Calcium and Vitamin-D: In mild hypercalciuria reduction of dose is sufficient to return to normal serum Calcium concentration. Plasma and serum Calcium level should be monitored in mild to moderate renal impairment patients and also in case of long term use. Patients with renal stone or with such previous history should be recommended to increase their fluid intake.
",,"No specific information is available on the treatment of over dosage of Ibandronic acid. However, based on knowledge of this class of compounds, oral over dosage may result in hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events.
",,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",11
+1199,Ibandronic Acid & Calcium Orotate,ibandronic-acid-calcium-orotate-1199,,Minerals in bone formation,Post-menopausal osteoporosis,"This Kit is indicated for the treatment and prevention of osteoporosis in women (especially after menopause) & men. It increases bone mineral density (BMD) and reduces the incidence of vertebral fractures.
","Minerals in bone formation, Specific mineral preparations
",,"One tablet of Ibandronic Acid 150 mg once monthly of the same date of each month is recommended. To maximize the clinical benefit of Ibandronic Acid, two tablets of Calcium Orotate per day are usually recommended in divided dosage.
To maximize absorption and clinical benefit, Ibandronic Acid tablet of this Kit should be taken at least 60 minutes before the first food or drink (other than water) of the day or before taking any oral medication or supplementation, including calcium, antacids, or vitamins.
To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, Ibandronic Acid tablet should be swallowed whole with a full glass of plain water (250 ml) while the patient is standing or sitting in an upright position. Patients should not lie down for 60 minutes after taking Ibandronic Acid tablet.
Ibandronic Acid 150 mg tablet of this Kit should be taken on the same date of each month (i.e., the patients Ibandronic Acid day)
If the once monthly dose is missed, and the patients next scheduled Ibandronic Acid day is more than 7 days away, the patient should be instructed to take one Ibandronic Acid 150 mg tablet in the morning following the date that it is remembered. The patient should then return to taking one Ibandronic Acid 150 mg tablet every month in the morning of their chosen day, according to their original schedule.
If the once monthly dose is missed, and the patients next scheduled Ibandronic Acid day is only 1 to 7 days away, the patient must wait until the subsequent month’s scheduled Ibandronic Acid day to take their tablet. The patient should then return to taking one Ibandronic Acid 150 mg tablet every month in the morning of their chosen day according to their original schedule.
The Patient must not take two Ibandronic Acid 150 mg tablets within the same week.
Start taking Calcium Orotate tablets from the next day of Ibandronic Acid day (from day-2 and onwards).
",,"Ibandronic Acid: Products containing calcium and other multivalent cautions (such as aluminium, magnesium, iron) are likely to interfere with absorption of Ibandronic Acid. Ibandronic Acid should be taken at least 60 minutes before any oral medications. Aspirin, NSAIDs, and bisphosphonates are all associated with gasrointestinal irritation, caution should be exercised in the concomitant use of aspirin of NSNADs with Ibandronic Acid.
Calcium Orotate: Calcium can decrease the absorption of the other drugs such as bisphosphonates (e.g., alendronate/risedronate), quinolone antibiotics (e.g., ciprofloxacin, levofloxacin), and tetracycline antibiotic (e.g., doxycycline, levofloxacin).
","Ibandronic Acid: Abnormalities of the esophagus, hypocalcemia, known hypersensitivity to Ibandronic Acid or any of its components.
Calcium Orotate: Incomplete bowel movements, Kidney stone, Kidney disease and lung disease.
","Ibandronic Acid: Common side effects include Hypertension, Dyspepsia, Nausea, Diarrhea, Abdominal Pain, Arthralgia, Back Pain, Localized Osteoarthritis, Myalgia, Muscle Cramp, Influenza, Nasopharyngitis, Bonchitis, Urinary Tract Infection, Upper Respiratory Tract Infection, Headache, Dizziness, Skin Rash, Insomnia etc.
Calcium Orotate: Bloating and swelling in the abdomen are common side effects of Calcium Orotate, loss of appetite, upset stomach, constipation, nausea, vomiting, unusual weight loss, mood changes, bone/muscle pain, headache, increased thirst/urination, weakness, unusual tiredness, formation of kidney stones may occur infrequently.
","There are no adequate and well-controlled studies in pregnant women for this kit. This kit should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus. It is not known whether this kit is excreted in human milk. Caution should be exercised when this kit is administered to a nursing woman.
","Ibandronic Acid:
+
+- Ibandronic Acid of this Kit may cause local irritation of the upper gastrointestinal mucosa.
+- Adequate intake of Calcium is important in all patient hypocalcaemia
+- Severe and occasionally incapacitating bone joint, and/or muscle pain has been reported in patients taking Ibandronic Acid.
+- Ibandronic Acid is not recommended for use in patients with severe renal impairment (Creatinine clearance of <30 ml/min).
+
+Calcium Orotate: Before taking Calcium Orotate, precaution is needed if the patient is allergic to Calcium Orotate. Any Calcium supplement taken without food may increase the risk of kidney stones. Therefore, it is advisable that Calcium Orotate be taken with food.
","Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Renal and hepatic impaired patient: No dose adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is equal to or greater than 30 ml/min. No dose adjustment is required for patients with hepatic impairment.
",,,,"Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.
",10
+592,Ibandronic Acid,ibandronic-acid-592,https://medex.com.bd/attachments/6ELgMJ3qLGRPGJDQlFuCNF12O3XtGH/ibandronic-acid-injection-prescribing-information,Bisphosphonate preparations,Hypercalcaemia of malignancy,"Ibandronic acid is indicated for the treatment of postmenopausal osteoporosis, to reduce the risk of fractures.
Treatment of Osteoporosis: Osteoporosis may be confirmed by the finding of low bone mass (T-score <-2.0 SD) and the presence or history of osteoporotic fracture, or a low bone mass (T-score <-2.5 SD) in the absence of documented pre-existing osteoporotic fracture.
","Bisphosphonate preparations
","The pharmacodynamic action of ibandronic acid is inhibition of bone resorption. In vivo, ibandronic acid prevents experimentally induced bone destruction caused by cessation of gonadal function, retinoids, tumors or tumor extracts. In young (fast growing) rats, the endogenous bone resorption is also inhibited, leading to increased bone mass compared with untreated animals. Animal models confirm that ibandronic acid is a highly potent inhibitor of osteoclastic activity. In growing rats, there was no evidence of impaired mineralization even at doses greater than 5,000 times the dose required for osteoporosis treatment. The high potency and therapeutic margin of ibandronic acid allows for more flexible dosing regimens and intermittent treatment with long drug-free intervals at comparatively low doses.
Ibandronic acid is a highly potent bisphosphonate belonging to the nitrogen-containing group of bisphosphonates, which act on bone tissue and specifically inhibit osteoclast activity, It does not interfere with osteoclast recruitment. The selective action of ibandronic acid on bone tissue is based on the high affinity of this compound for hydroxyapatite, which represents the mineral matrix of the bone. Ibandronic acid reduces bone resorption, with no direct effect on bone formation. In postmenopausal women, it reduces the elevated rate of bone turnover towards premenopausal levels, leading to a progressive net gain in bone mass. Daily or intermittent administration of ibandronic acid results in reduced bone resorption as reflected in reduced levels of serum and urinary biochemical markers of bone turnover, increased BMD and a decreased incidence of fractures.
","The recommended dose of Ibandronic acid for treatment is one 150 mg film-coated tablet once a month. The tablet should preferably be taken on the same date each month. Ibandronic acid should be taken 60 minutes before the first food or drink (other than water) of the day or any other oral medication or supplementation (including calcium):
+
+- Tablets should be swallowed whole with a full glass of plain water (180 to 240 ml) while the patient is sitting or standing in an upright position. Patients should not lie down for 60 minutes after taking Ibandronic acid.
+- Plain water is the only drink that should be taken with Ibandronic acid. Please note that some mineral waters may have a higher concentration of calcium and therefore should not be used.
+- Patients should not chew or suck the tablet because of a potential for oropharyngeal ulceration. Patients should receive supplemental calcium or vitamin D if dietary intake is inadequate. In case a once-monthly dose is missed, patients should be instructed to take one Ibandronic Acid 150 mg tablet the morning after the tablet is remembered unless the time to the next scheduled dose is within 7 days. Patients should then return to taking their dose once a month on their originally scheduled date. If the next scheduled dose is within 7 days, patients should wait until their next dose and then continue taking one tablet once a month as originally scheduled. Patients should not take two 150 mg tablets within the same week.
+
",,"It is likely that calcium supplements, antacids and some oral medications containing multivalent cations (such as aluminium, magnesium, iron) are likely to interfere with the absorption of Ibandronic Acid. Therefore, patients must wait 60 minutes after taking Ibandronic Acid before taking other oral medications. Pharmacokinetic interaction studies in postmenopausal women have demonstrated the absence of any interaction potential with tamoxifen or hormone replacement therapy (estrogen). No interaction was observed when co-administered with melphalan/prednisolone in patients with multiple myeloma. In healthy male volunteers and postmenopausal women, i.v. ranitidine caused an increase in ibandronic acid bioavailability of about 20 %, probably as a result of reduced gastric acidity. However, since this increase is within the normal range of the bioavailability of ibandronic acid, no dosage adjustment is required when Ibandronic Acid is administered with H2-antagonists or other drugs which increase gastric pH.
In relation to disposition, no drug interactions of clinical significance are considered likely, since ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and has been shown not to induce the hepatic cytochrome P450 system in rats. Furthermore, plasma protein binding is low at therapeutic concentrations and ibandronic acid is therefore unlikely to displace other drugs. Ibandronic acid is eliminated by renal excretion only and does not undergo any biotransformation. The secretory pathway appears not to include known acidic or basic transport systems involved in the excretion of other drugs. In a one-year study in postmenopausal women with osteoporosis (BM16549). the incidence of upper gastrointestinal events in patients concomitantly taking aspirin or NSAIDs was similar in patients taking Ibandronic Acid 2.5 mg daily or 150mg once monthly. Of over 1500 patients enrolled in study BM 16549 comparing monthly with daily dosing regimens of ibandronic acid, 14% of patients used histamine (H2) blockers or proton pump inhibitors. Among these patients, the incidence of upper gastrointestinal events in the patients treated with Ibandronic Acid 150 mg once monthly was similar to that in patients treated with Ibandronic Acid 2.5 mg daily.
","Ibandronic Acid is contraindicated in patients with known hypersensitivity to ibandronic acid or to any of the excipients. Ibandronic Acid is contraindicated in patients with uncorrected hypocalcemia. As with all bisphosphonates indicated in the treatment of osteoporosis, pre-existing hypocalcemia needs to be corrected before initiating therapy with Ibandronic Acid. As with several bisphosphonates, Ibandronic Acid is contraindicated in patients with abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia. Ibandronic Acid is contraindicated in patients who are unable to stand or sit upright for at least 60 minutes.
","The main side effects of ibandronic acid are dyspepsia, nausea, diarrhea, abdominal pain, muscle aches, headaches, dizziness.
","Pregnancy: Ibandronic Acid should not be used during pregnancy. There was no evidence for a direct fetal toxic or teratogenic effect of ibandronic acid in daily orally treated rats and rabbits and there were no adverse effects on the development in F1 offspring in rats. Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class. They include a decreased number of implantation sites, interference with natural delivery (dystocia), and an increase in visceral variations (renal pelvis ureter syndrome). Specific studies for the monthly regimen have not been performed. There is no clinical experience with Ibandronic Acid in pregnant women.
Nursing Mothers: Ibandronic Acid should not be used during lactation. In lactating rats treated with 0.08 mg/kg/day IV. ibandronic acid, the highest concentration of ibandronic acid in breast milk was 8.1 ng/ml and was seen in the first 2 hours after i.v. administration. After 24 hours, the concentration in milk and plasma was similar, and corresponded to about 5 % of the concentration measured after 2 hours.
","Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Ibandronic Acid therapy. Adequate intake of calcium and vitamin D is important in all patients. Orally administered bisphosphonates may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Ibandronic Acid is given to patients with active upper gastrointestinal problems (e.g. known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers). Adverse experiences such as esophagitis, esophageal ulcers and esophageal erosions, in some cases severe and requiring hospitalization, rarely with bleeding or followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates. The risk of severe esophageal adverse experiences appears to be greater in patients who do not comply with the dosing instruction and/or who continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation. Patients should pay particular attention and be able to comply with the dosing instructions.
Physicians should be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue Ibandronic Acid and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn. While no increased risk was observed in controlled clinical trials there have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications. Since NSAIDs and bisphosphonates are both associated with gastrointestinal irritation, caution should be taken during concomitant medication with Ibandronic Acid. Osteonecrosis of the jaw (ONJ) has been reported in patients treated with bisphosphonates. Most cases have been in cancer patients undergoing dental procedures, but some have occurred in patients with postmenopausal osteoporosis or other diagnoses. Known risk factors for osteonecrosis of the jaw include a diagnosis of cancer, concomitant therapies (e.g., chemotherapy, radiotherapy, corticosteroids), and co-morbid disorders (e.g., anemia, coagulopathy, infection, pre-existing dental disease). Most reported cases have been in patients treated with bisphosphonates intravenously but some have been in patients treated orally. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit-risk assessment.
","Patients with renal impairment: No dosage adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is ≥30 ml/min. Below 30 ml/min creatinine clearance, the decision to administer Ibandronic Acid should be based on an individual risk-benefit assessment.
Patients with hepatic impairment: No dosage adjustment is necessary.
+
Elderly: No dosage adjustment is necessary.
+
+
Children: Safety and efficacy have not been established in patients less than 18 years old.
","No specific information is available on the treatment of overdosage with ibandronic acid. However, oral overdosage may result in upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer. Milk or antacids should be given to bind ibandronic acid. Owing to the risk of esophageal irritation, vomiting should not be induced and the patient should remain fully upright.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+591,Hypromellose + Carbomer,hypromellose-carbomer-591,https://medex.com.bd/attachments/FVZ9hyx5awLaNRa80Dxuc0E8qyrGHu/hypromellose-carbomer-prescribing-information,Drugs for Dry eyes,Unstable tear film,"This Gel is a substitute tear fluid for the alleviation of dry eye conditions as well as for the management of an unstable tear film.
","Drugs for Dry eyes
","This eye for all patients with ocular discomfort. The slight hypotonicity of the gel is rapidly ""neutralised"" by the slightly hypertonic tear fluid caused by dry eyes.
","Instill 1 drop in the conjunctival sac of the affected eye(s), as needed. The frequency of administration depends on the severity of the condition. On average, one drop is administered 1-3 times daily. If needed, This Gel may be administered more frequently.
",,,"Hypersensitivity to any of the ingredients of this product.
","This Gel is very well tolerated by users. However, some cases of burning, stinging, allergic reactions or red eyes after instillation have been reported. Transient blurring of vision after administration has also been reported.
","Use in pregnancy & lactation: There is no experience regarding the safety of this Gel in human pregnancy or lactation.
","
+- If eye pain, changes in vision, continued redness or irritation of the eye are noticed, this Gel must be discontinued and a doctor should be consulted.
+- If this gel colour is change or becomes cloudy, the product should not be used.
+- It should never be injected subconjunctivally, nor should be directly introduced into the anterior chamber of the eye.
+- It is not intended to be used during surgery.
+
","Use in children: Studies in the pediatric population have not been performed.
Use in elderly patients: There is no indication that dosage needs to be modified for the elderly.
",,,,,9
+1544,Hypromellose,hypromellose-1544,,Drugs for Dry eyes,,"Ophthalmic Solution: Hypromellose dye drop is indicated in tear deficiency due to:
+
+- Impaired lacrimal secretion and
+- Functional disorders as a result of topical or systemic diseases or
+- Caused by deficient or incomplete eyelid closure.
+
+
Ophthalmic Gel ... Read more Ophthalmic Solution: Hypromellose dye drop is indicated in tear deficiency due to:
+
+- Impaired lacrimal secretion and
+- Functional disorders as a result of topical or systemic diseases or
+- Caused by deficient or incomplete eyelid closure.
+
+
Ophthalmic Gel: Hypromellose enriched with Carbomer 980 is a long-acting eye gel for lubricating the surface of the eye for all patients with ocular discomfort. The slight hypotonicity of the gel is rapidly ""neutralized"" by the slightly hypertonic tear fluid caused by dry eyes.
","Drugs for Dry eyes
","Hypromellose is a semisynthetic, inert and viscoelastic polymer used as an ophthalmic lubricant. Hypromellose acts as a lubricant and artificial tear in the symptomatic treatment of dehydration of the cornea and conjunctiva due to impaired lacrimal secretion and functional disorders as a result of topical or systemic diseases, or caused by deficient or incomplete eyelid closure.
","Ophthalmic Solution: Therapy of dry eye syndrome requires an individual dosage regimen.
+
+- The usual dose of 0.3% Hypromellose is 1 drop into the conjunctival sac 3 to 5 times per day or as directed by the physician.
+- The dose of 0.5% Hypromellose will be different for different patients. Follow your doctor's directions.
+
+
Ophthalmic Gel: Instill 1 or 2 drops in the conjunctival sac of the affected eye(s), as needed. The frequency of administration depends on the severity of the condition. On average, one drop is administered 1-3 times daily. If needed, Hypromellose may be administered more frequently.
",,"Hypromellose can be used in combination with contact lenses. No compatibility study with lens material is available.
","Hypersensitivity to this drug or to any ingredient in the formulation or component of the container.
","Common side effects are brief blurred vision or a slight stinging sensation on instilling Hypromellose. Hypromellose enriched with Carbomer 980 is very well tolerated by users. However, some cases of burning, stinging, allergic reactions or red eyes after instillation have been reported. Transient blurring of vision after administration has also been reported.
","There is no experience regarding the safety of Hypromellose in human pregnancy or lactation. Studies in the pediatric population have not been performed.
","If eye pains, changes in vision, continued redness or irritation of the eye are noticed Hypromellose must be discontinued and a doctor should be consulted. If Hypromellose changes color or becomes cloudy, the product should not be used.
",,,,,"Store in a cool dry place, away from light. Keep out of reach of children. Do not touch tip of the tube surface since this may contaminate the gel. After one month of the opening do not use the medicine of tube.
",10
+589,Hyoscine Hydrobromide,hyoscine-hydrobromide-589,https://medex.com.bd/attachments/irqO4y9yOlNuVEwJbGwpC33TQmNVXs/hyoscine-hydrobromide-prescribing-information,Anti-emetic drugs,Motion sickness,"Hyoscine Hydrobromide is indicated in the prevention and control of nausea and vomiting associated with motion sickness/travel sickness.
","Anti-emetic drugs
","Hyoscine Hydrobromide is a type of medicine called an antimuscarinic (or anticholinergic). Hyoscine hydrobromide is sometimes known as scopolamine. It is thought to prevent motion sickness by stopping the messages sent from the vestibular system to reach an area of the brain called the vomiting centre. This area of the brain coordinates the vomiting reflex.
","Adults and children over 13 years: 2 tablets (Maximum 4 tablets in 24 hours).
Children age 7-12 years: 1-2 tablets (Maximum 2 tablets in 24 hours).
Children age 4-7 years: 1 tablet (Maximum 2 tablets in 24 hours).
Children age 3-4 years: half a tablet (Maximum 1 tablet in 24 hours).
Children under 3 years: Not recommended under 3 years or as directed by the physician.
","Ideally, take tablets 30 minutes before the journey.
","Additive sedative effects with alcohol or other CNS depressants. Reduced effects with acetylcholinesterase inhibitors (donepezil, galantamine, rivastigmine, tacrine).
","Hyoscine Hydrobromide is contraindicated in Glaucoma/Blindness.
","Dry mouth, dizziness, blurred vision, difficulty with micturition.
","Not recommended during pregnancy and lactation.
","May cause drowsiness, if affected do not drive or operate machinery. May be potentiated by concurrent phenothiazines, tricyclic antidepressants or alcohol. Absorption may be reduced by aluminium hydroxide preparations.
","Children: This product only be given to children over 3 years old
",,,,"Store in a cool & dry place. Keep out of the reach of children.
",12
+588,Hyoscine Butylbromide,hyoscine-butylbromide-588,https://medex.com.bd/attachments/9vzt56WnTUc0SOa2ojxTecNU8wtijm/hyoscine-butylbromide-prescribing-information,Anticholinergics (antimuscarinics)/ Anti-spasmodics,Pancreatitis,"হায়োসিন বিউটাইলব্রোমাইড একটি এন্টিকোলিনার্জিক ওষুধ, এবডোমিনাল ক্যাভিটির বিভিন্ন অংশের নরম মাংসপেশীর (smooth muscle) উপর যার খিঁচুনিবিরোধী (antispasmodic) ক্রিয়া রয়েছে। হায়োসিন বিউটাইলব্রোমাইড ট্যাবলেট গ্যাসট্রো ইন্টেসটিনাল ট্র্যাক্টে অথবা জেনিটো-ইউরিনারী ট্র্যাক্টের ভিসেরাল খিঁচুনি জনিত লক্ষণসমূহে নির্দেশিত। স্পাসমোডিক ডিসমেনোরিয়াতেও এটি নির্দেশিত। হায়োসিন বিউটাইলব্রোমাইড ইনজেকশন গ্যাসট্রো-ইন্টেসটিনাল খিঁচুনি এবং রেনাল অথবা পিত্তের (billary) তীব্র ব্যথাতেও নির্দেশিত। রেডিওলজীতে প্রতিবন্ধকতার পার্থক্যমূলক রোগ নির্ণয়ে, পাইলোগ্রাফীতে খিঁচুনি ও ব্যথা কমাতে এবং গ্যাসট্রো-ডিওডেনাল এনডোস্কোপীর মত রোগ নির্ণয়ের অন্যান্য পদ্ধতিতেও খিঁচুনির ���মস্যা দূর করার জন্য হায়োসিন বিউটাইলব্রোমাইড ইনজেকশন ব্যবহার করা হয়।
","Anticholinergics (antimuscarinics)/ Anti-spasmodics
",,"খাওয়ার জন্য-
+
+- প্রাপ্ত বয়স্ক: ২০ মিগ্রা দিনে চার বার। স্পাসমোডিক ডিসমেনোরিয়ার ক্ষেত্রে ঋতুস্রাব (menstruation) শুরুর সম্ভাব্য তারিখের কমপক্ষে দুদিন আগে থেকে চিকিৎসা শুরু করতে হবে এবং স্রাব শুরুর তিনদিন পরে পর্যন্ত তা অব্যাহত রাখতে হবে।
+- শিশু ৬ থেকে ১২ বৎসর পর্যন্ত: ১০ মিগ্রা দিনে তিনবার অথবা চিকিৎসকের নির্দেশ অনুযায়ী।
+
+ইনজেকশন হিসেবে-
+
+- প্রাপ্তবয়স্ক: মাংসপেশীতে বা শিরাপথে প্রয়োগের জন্য সাধারণ মাত্রা হচ্ছে ২০ মিগ্রা (১টি এ্যাম্পুল), প্রয়োজনে যা কিনা ৩০ মিনিট পর পুনরায় প্রয়োগ করতে হবে। এনডোস্কোপীর ক্ষেত্রে এই মাত্রা আরো ঘন ঘন প্রয়োগ করতে হবে।
+
",,,"যে সব রোগীর প্রস্টেটিক বৃদ্ধি ঘটেছে তাদের ক্ষেত্রে এর ব্যবহার নিষিদ্ধ এবং বৃদ্ধদের ক্ষেত্রে এটি সতর্কতার সাথে ব্যবহার করতে হবে। যে সব রোগী প্যারালাইটিক ইলিয়াস অথবা পাইলোরিক ষ্টেনোসিসে ভুগছেন তাদের ক্ষেত্রেও ওষুধটির ব্যবহার নিষিদ্ধ। সম্ভাব্য মাইড্রিয়াটিক ক্ষতির কারণে যে সব রোগীর গ্লুকোমা রয়েছে তাদের ক্ষেত্রেও এটির ব্যবহার নিষিদ্ধ ।
","হায়োসিন বিউটাইলব্রোমাইড এর পার্শ্ব-প্রতিক্রিয়ার মধ্যে রয়েছে মুখ শুকিয়ে যাওয়া, পিউপিল এর প্রসরণ (dilatation), ইন্ট্রা-অকিউলার প্রেসার বৃদ্ধি, ফ্লাসিং, ত্বক শুকিয়ে যাওয়া, ব্র্যাডিকার্ডিয়া এবং তারপরেই ট্যাকিকার্ডিয়া ও এরিমিয়া। কখনো কখনো ক্লান্তি, বমি, মাথা ঝিমঝিম (giddiness) এবং ষ্ট্যাগারিং হতে পারে।
","গর্ভাবস্থার প্রথম তিন মাসে অন্যান্য ওষুধের মতো একেও সতর্কতার সাথে ব্যবহার করতে হবে।
","সাবধানতা: হায়োসিন ঝিমুনি সৃষ্টি করতে পারে ও মানসিক সতর্কতা নিজে করে নিস্তেজ করে দিতে পারে। যে সকল রোগী হায়োসিন দিয়ে চিকিৎসাধীন রয়েছে তাদের গাড়ী বা অন্যান্য যানবাহন অথবা মানসিক একাগ্রতার অভাবে দুর্ঘটনা ঘটতে পারে এমন কোন যন্ত্রপাতি চালানো উচিত নয়। রোগীদের মদ্যপান করা থেকেও বিরত থাকা উচিত।
সতর্কতা: থাইরোটক্সিকোসিস, কার্ডিয়াক অপর্যাপ্ততা (insufficiency) বা ফেলিওর এবং হৃদপিন্ডে অস্ত্রোপচারের ক্ষেত্রে এই ওষুধ হৃদপিন্ডের গতি আরো বাড়িয়�� দিতে পারে বলে এর ব্যবহারে সতর্কতা অবলম্বন করা উচিত। অন্যান্য এন্টিকোলিনার্জিক ওষুধসমূহ যেমন এমানটেডিন, কোন কোন এন্টিহিস্টামিন, বিউটাইরোফেনন ও ফেনোথায়াজিন এবং ট্রাইসাইক্লিক এন্টিডিপ্রেসেন্ট হায়োসিনের সাথে একত্রে প্রয়োগের ফলে হায়োসিনের ক্রিয়া বেড়ে যেতে পারে বিধায় এ সব ক্ষেত্রে হায়োসিন ব্যবহার করতে হলে এর মাত্রা কমিয়ে নেয়া প্রয়োজন হতে পারে।
",,,,"ডেক্সট্রান কিংবা ০.৯% সোডিয়াম ক্লোরাইড ইনজেকশনের তরল দিয়ে হায়োসিন বিউটাইলব্রোমাইড ইনজেকশনকে তরলীকরণ করা যাবে।
","মেয়াদ উত্তীর্ণের পর ব্যবহার করবেন না। সকল ওষুধ শিশুদের নাগালের বাইরে রাখুন। কেবলমাত্র রেজিস্টার্ড চিকিৎসকের ব্যবস্থাপত্র অনুযায়ী বিতরণযোগ্য।
",9
+1559,Hylan G-F 20,hylan-g-f-20-1559,https://medex.com.bd/attachments/nG6MNfNeor6Uc8KaMUoHvqnWM0r9zn/hylan-g-f-20-prescribing-information,Drugs for Osteoarthritis,Osteoarthritis (degenerative arthritis),"Hylan G-F is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, e.g., acetaminophen.
","Drugs for Osteoarthritis
","Joints contain a fluid, called synovial fluid, which acts as a lubricant and shock absorber. Patients with osteoarthritis have synovial fluid that is thinner than normal, and, therefore, it is less effective as a lubricant and shock-absorber. Hylan G-F 20 is an elastic fluid that is made from a substance called hyaluronan, that is found in normal joint fluid. Hyaluronan is the key substance in joint fluid that provides the shock-absorbing quality to the fluid, and it is essential for the proper functioning of joints. When Hylan G-F 20 is injected into the knee of a patient with osteoarthritis, the drug helps to restore the shock-absorbing effect of the fluid within the knee. This can reduce pain, resulting in a more active lifestyle.
","Hylan G-F 20 is administered by intra-articular injection once a week (one week apart) for a total of three injections. Strict aseptic administration technique must be followed.
+
+- Using an 18- to 22-gauge needle, remove synovial fluid or effusion before each Hylan G-F 20 injection.
+- Do not use the same syringe for removing synovial fluid and for injecting Hylan G-F 20 however the same 18- to 22-gauge needle should be used.
+- Twist the tip cap before pulling it off, as this will minimize product leakage.
+- To ensure a tight seal and prevent leakage during administration, secure the needle tightly while firmly holding the luer hub.
+
",,"No information provided.
","Do not administer to patients with known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations. Do not inject Hylan G-F in the knees of patients having knee joint infections or skin diseases or infections in the area of the injection site
","The most commonly reported adverse events associated with Hylan G-F 20 are the following: Pain in the injected knee, Swelling in the injected knee, Joint effusion
","Pregnancy: The safety and effectiveness of Hylan G-F 20 have not been established in pregnant women.
Nursing mothers: It is not known if Hylan G-F 20 is excreted in human milk. The safety and effectiveness of Hylan G-F 20 have not been established in lactating women.
","
+- The effectiveness of a single treatment cycle of less than three injections (2 mL each) of Hylan G-F 20 has not been established.
+- The safety and effectiveness of Hylan G-F 20 in locations other than the knee and for conditions other than osteoarthritis have not been established.
+- The safety and effectiveness of the use of Hylan G-F 20 concomitantly with other intra-articular injectables have not been established.
+- Use caution when injecting Hylan G-F 20 into patients who are allergic to avian proteins, feathers, and egg products.
+- The safety and effectiveness of Hylan G-F 20 in severely inflamed knee joints have not been established.
+- Strict aseptic administration technique must be followed.
+- STERILE CONTENTS. The syringe is intended for single use. The contents of the syringe must be used immediately after its packaging is opened. Discard any unused Hylan G-F 20.
+- Do not use Hylan G-F 20 if package is opened or damaged. Store in original packaging (protected from light) at room temperature below 86°F (30°C). DO NOT FREEZE.
+- Remove synovial fluid or effusion before each Hylan G-F 20 injection.
+- Hylan G-F 20 should be used with caution when there is evidence of lymphatic or venous stasis in the leg to be injected.
+
+Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because hyaluronan can precipitate in their presence. Do not inject Hylan G-F extra-articularly or into the synovial tissues and capsule. Local and systemic adverse events, generally in the area of the injection, have occurred following extra-articular injection of Hylan G-F. Intravascular injections of Hylan G-F may cause systemic adverse events.
","Pediatrics: The safety and effectiveness of Hylan G-F have not been established in pediatric patients. Pediatric patients are defined as patients ≤ 21 years of age.
",,,,"Do not use Hylan G-F 20 if the package has been opened or damaged. Store in original packaging (protected from light) at room temperature below 86°F (30°C). DO NOT FREEZE.
",11
+587,Hydroxyzine Hydrochloride,hydroxyzine-hydrochloride-587,https://medex.com.bd/attachments/Z73VcdJWVYxbZgJcMBv26MmGBej0F5/hydroxyzine-hydrochloride-prescribing-information,Sedating Anti-histamine,Urticaria,"Hydroxyzine Hydrochloride is indicated-
+
+- For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.
+- Management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and histamine-mediated pruritus.
... Read more
Hydroxyzine Hydrochloride is indicated-
+
+- For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.
+- Management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and histamine-mediated pruritus.
+- As a sedative when used as premedication and following general anesthesia.
+
+The effectiveness of Hydroxyzine as an antianxiety agent for long-term use (>4 months) has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.
","Sedating Anti-histamine
","Hydroxyzine Hydrochloride is an anxiolytic antihistamine of the piperazine class which is a H1 receptor antagonist. Hydroxyzine is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system. Primary skeletal muscle relaxation has been demonstrated experimentally. Bronchodilator activity and antihistaminic and analgesic effects have been demonstrated experimentally and confirmed clinically. An antiemetic effect, both by the apomorphine test and the veriloid test, has been demonstrated. Hydroxyzine is rapidly absorbed from the gastrointestinal tract and clinical effects are usually noted within 15 to 30 minutes after oral administration.
","For symptomatic relief of anxiety and tension-
+
+- Adults: 50-100 mg 4 times daily.
+- Children (>6 years): 50-100 mg (5-10 teaspoonfuls) daily in divided doses.
+- Children (<6 years): 50 mg (5 teaspoonfuls) daily in divided doses.
+
+Pruritus due to allergic conditions-
+
+- Adults: 25 mg 3 to 4 times daily.
+- Children ( 6 years): 50-100 mg (5-10 teaspoonfuls) daily in divided doses.
+- Children (<6 years): 50 mg (5 teaspoonfuls) daily in divided doses.
+
+As a sedative (premedication and following general anesthesia)-
+
+- Adults: 50-100 mg.
+- Children: 0.6 mg/kg of body weight.
+
",,"Hydroxyzine may potentiate Meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. Simultaneous administration of Hydroxyzine with monoamine oxidase inhibitors should be avoided.
","Hydroxyzine is contraindicated in patients with a known hypersensitivity to Hydroxyzine or any of its ingredients.
","Side effects reported with the administration of Hydroxyzine Hhydrochloride are usually mild and transitory in nature. More common side effects include drowsiness, headache, psychomotor impairment, and antimuscarinic effects such as urinary retention, dry mouth, blurred vision, and gastrointestinal disturbances. Other rare side-effects of antihistamines include hypotension, palpitation, arrhythmias, extrapyramidal effects, dizziness, confusion, depression, sleep disturbances, tremor, convulsions, hypersensitivity reactions (including bronchospasm, angioedema, and anaphylaxis, rashes, and photosensitivity reactions), blood disorders, liver dysfunction, and angle-closure glaucoma.
","Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, Hydroxyzine is contraindicated in early pregnancy. It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, Hydroxyzine should not be given to nursing mothers.
","The potentiating action of Hydroxyzine must be considered when the drug is used in conjunction with central nervous system depressants such as narcotics, non-narcotic analgesics, and barbiturates. Therefore, when central nervous system depressants are administered concomitantly with Hydroxyzine, their dosage should be reduced. Since drowsiness may occur with the use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking Hydroxyzine. Patients should be advised against the simultaneous use of other CNS depressant drugs and cautioned that the effect of alcohol may be increased.
","Use in renal impairment patient: In case of renal impairment, half of the normal dose should be given.
Use in the elderly patient: In the elderly, it is advised to start with half the recommended dose due to the prolonged action.
","The most common manifestation of Hydroxyzine overdosage is hypersedation. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.
If vomiting has not occurred spontaneously, it should be induced. Immediate gastric lavage is also recommended. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated. Hypotension, though unlikely, may be controlled with intravenous fluids and Levarterenol or Metaraminol. Epinephrine should not be used as Hydroxyzine counteracts its pressor action.
There is no specific antidote. It is doubtful that hemodialysis would be of any value in the treatment of overdosage with Hydroxyzine. However, if other agents such as barbiturates have been ingested concomitantly, hemodialysis may be indicated. There is no practical method to quantitate Hydroxyzine in body fluids or tissue after its ingestion or administration.
",,,"Store in a cool & dry place. Protect from light. Keep out of the reach of children.
",12
+586,Hydroxyurea,hydroxyurea-586,https://medex.com.bd/attachments/bEaeQqsKHr8UI08aIImOGXazM7EQAS/hydroxyurea-prescribing-information,Cytotoxic Chemotherapy,Sickle-cell disease,"Hydroxyurea is indicated for the treatment of resistant chronic myeloid leukemia, locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation.
","Cytotoxic Chemotherapy
","Hydroxyurea is converted to a free radical nitroxide (NO) in vivo, and transported by diffusion into cells where it quenches the tyrosyl free radical at the active site of the M2 protein subunit of ribonucleotide reductase, inactivating the enzyme. The entire replicase complex, including ribonucleotide reductase, is inactivated and DNA synthesis is selectively inhibited, producing cell death in S phase and synchronization of the fraction of cells that survive. Repair of DNA damaged by chemicals or irradiation is also inhibited by hydroxyurea, offering potential synergy between hydroxyurea and radiation or alkylating agents. Hydroxyurea also increases the level of fetal hemoglobin, leading to a reduction in the incidence of vasoocclusive crises in sickle cell anemia. Levels of fetal hemoglobin increase in response to activation of soluble guanylyl cyclase (sGC) by hydroxyurea-derived NO.
","Malignancies Chronic myeloid leukaemia: 20-30 mg/kg/day.
Solid tumours: 80 mg/kg every third day. With radiotherapy, start treatment 7 days before initiation of radiotherapy.
Sickle-cell disease: Initial: 15 mg/kg/day. Max: 35 mg/kg/ day. Adjust based on response and blood counts.
Essential thrombocythemia: 15 mg/kg/day. Adjust based on platelet counts.
",,"Impairs immune response to vaccines; possible infection with live vaccines, zidovudine, zalcitabine. May alter action of oral anticoagulants and phenytoin.
","Severe bone-marrow suppression, severe anaemia, WBC <3000/mm3 or platelet count <100,000/mm3. Pregnancy and lactation. Hypersensitivity.
","Gl disturbances, Nausea, Vomiting, Constipation, Diarrhea, Hyperuricemia, Renal failure, Rash, Hyperpigmentation. Pulmonary oedema, dermatological reactions, headache, dizziness. Disorientation, drowsiness, hallucinations, convulsions, alopecia.
","Pregnancy category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Lactation: Excreted in breast milk, do not nurse
","Regular monitoring of uric acid concentrations, blood counts, renal and hepatic function is recommended. Prior irradiation therapy. Elderly. Avoid use of live vaccines.
",,,,,,9
+1543,Hydroxypropyl Methylcellulose,hydroxypropyl-methylcellulose-1543,,Drugs for Dry eyes,Surgical aid in the anterior segment,"Hydroxypropyl Methylcellulose is indicated as a surgical aid (medical device) during surgicalprocedures involving the anterior chamber of the eye, including extraction of the lens and insertion of intra-ocular lenses. It maintains the depth of the anterior chamber during the whole surgical procedure ... Read more
Hydroxypropyl Methylcellulose is indicated as a surgical aid (medical device) during surgicalprocedures involving the anterior chamber of the eye, including extraction of the lens and insertion of intra-ocular lenses. It maintains the depth of the anterior chamber during the whole surgical procedure and permits greater operative precision without the risk of damaging the endothelium of the cornea or other intra-ocular tissues.
","Drugs for Dry eyes
","Hydroxypropyl Methylcellulose is a non pyrogenic viscoelastic solution that occupies space and protects tissue. When used in anterior segment surgeries, it allows for more efficient manipulation with less trauma to the ocular tissues, such as the corneal endothelium, by maintaining a deep chamber. The viscoelastic properties of Hydroxypropyl methylcellulose facilitate pushing back the vitreous face, which prevents the formation of a postoperative flat chamber.
","Each pre-filled syringe is for single intraocular use only. The quantity injected into the anterior chamber of the eye must be adjusted according to the volume of the aqueous humour and the anatomical structure to be protected.
",,"There are no specific drug interactions noted.
","At present, there are no known contraindications to the use of Hydroxypropyl Methylcellulose when used as recommended.
","Hydroxypropyl Methylcellulose has been extremely well tolerated after injection into the human eye. A transient rise in intraocular pressure postoperatively has been reported in some cases. Rarely, postoperative inflammatory reactions (iritis, hypopyon), as well as incidents of corneal edema and corneal decompensation, have been reported with viscoelastic agents.
","Pregnancy: Hydroxypropyl Methylcellulose has not been shown to cause birth defects or other problems in humans.
Lactation: It has not been reported to cause problems in nursing babies.
","Precautions are limited to those normally associated with the ophthalmic surgical procedure being performed. There may be transient increased intraocular pressure following surgery because of pre-existing glaucoma or due to the surgery itself. For these reasons, the following precautions should be considered. Hydroxypropyl Methylcellulose should be removed from the anterior chamber at the end of surgery. If the postoperative intraocular pressure increases above expected values, appropriate therapy should be administered.
Warning-
+
+- For intraocular use only
+- For single use only
+
",,"Mechanical blockage of drainage at the trabecular level may cause a transient increase in intraocular pressure after surgery.
",,,"Store in a cool and dry place,away from light. Do not freeze. Keep out of the reach of children.
",11
+1411,Hydroxyprogesterone Caproate,hydroxyprogesterone-caproate-1411,https://medex.com.bd/attachments/wkIwbhXmQ2xp5VZJRQsItsVCO7oO9x/hydroxyprogesterone-caproate-prescribing-information,Hormone preparations for other uses,Reduce the risk of preterm birth in women,"
+- Indicated for reducing the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth
+- Indicated for prevention of preterm labor in a singleton pregnancy for patients aged 16 years or older who have a history of spontaneous preterm birth
+
","Hormone preparations for other uses
","The mechanism by which progesterone prevents preterm birth is not well understood, but many pathways are likely involved. (1) Progesterone plays a vital role in regulation of the female reproductive system and is important for successful implantation of the embryo and maintenance of pregnancy. It acts by binding to progesterone receptors in the uterus, ovaries, breasts and in the central nervous system. These receptors exist in 2 isoforms, PR-A and PR-B. Progesterone binding to these receptors ultimately leads to regulation of gene transcription. (2) This results in an anti-inflammatory effect which blunts the proinflammatory state that occurs with initiation of labor, and maintains uterine queiscence by stabilizing progesterone acting on the myometrium.
","Administer intramuscularly at a dose of 500 mg or 250 mg once weekly. Begin treatment between 16 weeks, 0 days and 20 weeks, 6 days of gestation. Continue administration once weekly until week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first.
Administration-
+
+- Clean the ampoule top with an alcohol swab before use.
+- Draw up 1 ml of drug into a 2 ml syringe.
+- After preparing the skin, inject in the upper outer quadrant of the gluteus maximus. The solution is viscous and oily. Slow injection (over one minute or longer) is recommended.
+- Applying pressure to the injection site may minimize bruising and swelling.
+
",,,"
+- Current or history of thrombosis or thromboembolic disorders.
+- Known or suspected breast cancer, other hormone-sensitive cancer, or history of these conditions.
+- Undiagnosed abnormal vaginal bleeding unrelated to pregnancy.
+- Cholestatic jaundice of pregnancy.
+- Liver tumors, benign or malignant, or active liver disease.
+- Uncontrolled hypertension.
+
","Most Common: Injection site reactions (pain, swelling, pruritus, nodule), Hives, Itching, nausea, and diarrhea. Call your doctor if you get any of the symptoms below:
+
+- Blood clots Symptoms: Leg swelling, Redness in your leg, a spot on your leg that is warm to touch, Leg pain that worsens when you bend your foot.
+- Allergic reactions: Hives, Itching, Swelling of the face.
+
","Pregnancy: Category B. No adequate and well-controlled studies in women during first trimester of pregnancy. Teratogenic risks to infants following in utero exposure to the drug not demonstrated in a study of pregnant women receiving the drug during their second and third trimesters, as well as in a follow-up safety study of their infants. Not intended to stop active preterm labor; effect of drug for this use unknown.
Lactation: Detectable amounts of progestins identified in the breast milk of women receiving progestins. No adverse effects of progestins on breastfeeding performance or on health, growth, or development of infants, Discontinue drug at 37 weeks of gestation or upon delivery.
","
+- Thromboembolic disorders: Discontinue if thrombosis or thromboembolism occurs. Allergic reactions: Consider discontinuing if allergic reactions occur.
+- Decreased glucose tolerance: Monitor pre-diabetic and diabetic women receiving Hydroxyprogesterone Caproate.
+- Fluid retention: Monitor women with conditions that may be affected by fluid retention, such as pre-eclampsia, epilepsy, cardiac or renal dysfunction.
+- Depression: Monitor women with a history of clinical depression; discontinue Hydroxyprogesterone Caproate if depression recurs.
+- Jaundice: Carefully monitor women who develop jaundice while receiving Hydroxyprogesterone Caproate and consider whether the benefit of use warrants continuation.
+- Hypertension: Carefully monitor women who develop hypertension while receiving Hydroxyprogesterone Caproate and consider whether the benefit of use warrants continuation.
+
","Pediatric Use: Not indicated for use in pediatric patients. Safety and efficacy not established in pediatric patients <16 years of age. Limited number of women<18 years of age studied; safety and efficacy expected to be the same in women >16 years of age compared with those > 18 years of age.
Geriatric Use: Not evaluated in women >65 years of age. Not intended for use in postmenopausal women. Safety and efficacy not established in postmenopausal women.
Hepatic Impairment: Contraindicated in patients with liver tumors (benign or malignant) or active liver disease. Effect of hepatic impairment on pharmacokinetics of the drug not evaluated.
Renal Impairment: Effect of renal impairment on pharmacokinetics of the drug not evaluated.
","No adverse events associated with overdosage has been reported.
",,,"Store at controlled room temperature between 15°C to 30°C. Protects from light. Keep out of the reach of children.
",11
+898,Hydroxyethyl Starch + Sodium Chloride,hydroxyethyl-starch-sodium-chloride-898,https://medex.com.bd/attachments/t0Zq0GbLxsZswEAHzznaR2cipAQ2Nq/hydroxyethyl-starch-sodium-chloride-prescribing-information,Plasma expanders,Therapeutic dilution of blood,"Hydroxyethyl starch (HES 130/0.4) in an isotonic electrolyte solution for intravenous infusion. It belongs to a group of medicines known as plasma volume substitutes. They work by increasing and maintaining the circulating blood volume for several hours. This helps to keep your blood pressure stable ... Read more
Hydroxyethyl starch (HES 130/0.4) in an isotonic electrolyte solution for intravenous infusion. It belongs to a group of medicines known as plasma volume substitutes. They work by increasing and maintaining the circulating blood volume for several hours. This helps to keep your blood pressure stable. This solution is used for the treatment and prevention of low blood volumes (hypovolaemia) in adults and children.
","Plasma expanders
",,"This solution will be given to you by, or under the direct supervision of, your physician, who will closely control the amount of this solution given to you.
Mode of administration: You will receive this medicine by infusion into a vein (intravenous drip). The speed of infusion, along with the amount of solution infused, will depend on your specific requirements, the disease for which the product is being used, and by reference to the maximum daily dose.
Dosage: Your doctor will decide on the correct dose for you to receive. The recommended maximum daily dose is up to 50 ml of this solution per kg of body weight.
Use in children and adolescents: Your doctor may give the product to children after careful evaluation of advantages and disadvantages.
If you have received more of this solution than you should: Your doctor will ensure that you receive the right amount of this solution. However, different people need different doses, and if the dose does prove too much for you, your doctor may stop this solution immediately and, if necessary, administer medicine that removes water from the body (diuretic). If you have any further questions on the use of this product, please ask your doctor or pharmacist
",,"The safety and compatibility of other additives, other than citrate anticoagulant, have not been established. Incompatibilities: In the absence of incompatibility studies this medicinal product must not be mixed with other medicinal products.
","Do not use this solution if you:
+
+- suffer from severe generalized infection (sepsis)
+- have a severe liver disease
+- have a known allergy (hypersensitivity) to hydroxyethyl starch
+- have a clinical condition where too much fluid in your body is a potential problem, especially if you have too much fluid in your lungs (pulmonary edema) or if you suffer from a condition in which your heart cannot pump enough blood to other organs of your body (congestive heart failure)
+- have pre-existing blood clotting (coagulation) or bleeding disorders
+- suffer from kidney failure and you produce little or no urine if this is not caused by low blood volumes (hypovolaemia)
+- receive dialysis treatment
+- have a severe increase of potassium, sodium or chloride levels in your blood (severe hyperkalaemia, severe hypernatraemia or severe hyperchloraemia)
+- suffer from bleeding in the brain (intracranial bleeding).
+
","Common (may affect up to 1 in 10 people):
+
+- Itching is a known side effect of hydroxyethyl starches when used over long periods of time and at high doses.
+- Other effects are associated with the dilution of the blood, which occurs at high dosages, such as prolonged blood clotting time.
+- The level of the enzyme serum amylase can arise during the administration of hydroxyethyl starch and can interfere with the diagnosis of inflammation of the pancreas (pancreatitis). However, this solution does not cause pancreatitis.
+
","For this solution, no clinical data on exposed pregnancies are available. Your doctor will only give this solution after having weighed the benefits versus the potential risk to the baby. It is not known whether this drug is excreted in human milk. Your doctor will advise you whether to interrupt breastfeeding or not.
","It is important to tell your doctor if you have:
+
+- impairment of your liver function
+- problems with your heart or circulation
+- blood clotting (coagulation) disorders
+- problems with your kidneys
+
+In case of certain serious diseases, your doctor will consider using salt solutions instead of this solution. This solution should be avoided if you have kidney disease and must not be used if you are treated with dialysis.
",,,,,"Keep this medicine out of the sight and reach of children. Do not freeze. Do not store above 25°C.
",9
+1636,Hydroxyethyl Cellulose + Glycerin,hydroxyethyl-cellulose-glycerin-1636,,Miscellaneous topical agents,Lubrication,"Helps lubricating in sexual intercourse specially for post menopausal women to reduce irritation, for lubrication during vaginal examinations, endoscopy, catheterization for gloves and instruments.
","Miscellaneous topical agents
","Hydroxyethyl Cellulose and Glycerin are colorless, odorless, non-toxic viscous liquid. Both are used in medical, pharmaceutical and personal care preparations for improving smoothness & providing lubrication.
","Apply as required.
",,,"Usually well-tolerated. People with prior history of sensitivity or allergic reaction to this product or any of its ingredients should not use it.
",,,"Only for external use. When using this product do not get into eyes.
",,,,,"Store in a cool & dry place, protected from light. Keep out of reach of children.
",7
+584,Hydroxychloroquine Sulphate,hydroxychloroquine-sulphate-584,https://medex.com.bd/attachments/sTCNwjevNXA79e2JI5SF6USNZwjezK/hydroxychloroquine-sulphate-prescribing-information,Anti-malarial drugs,Systemic lupus erythematosus (SLE),"Hydroxychloroquine Sulphate is indicated in-
+
+- Acute and chronic rheumatoid arthritis
+- Systemic Lupus Erythematosus (SLE)
+- Malaria
+
","Anti-malarial drugs, Disease-modifying antirheumatic drugs (DMARDs), Drugs used for Rheumatoid Arthritis
","Hydroxychloroquine Sulphate synthetically produced version of quinine. It acts as an immunosuppressant by inhibiting production of rheumatoid and acute phase reactants. It also accumulates in white blood cells, stabilizing lysosomal membranes and inhibiting the activity of many enzymes, including collagenase and the proteases that cause cartilage breakdown. It also acts by disrupting cell walls of infected red blood cells and kills the developing parasites.
","Hydroxychloroquine Sulphate tablets are for oral administration and are taken with food to avoid stomach upset.
Acute and chronic rheumatoid arthritis: 400 to 600 mg daily. When good response is obtained (usually 4 to 8 weeks), dose can be reduced to 50%.
Systemic Lupus Erythematosus (SLE): 400 mg once or twice daily for several weeks or months depending on response of the patients. Maintenance dose is 200 to 400 mg daily.
Malaria: In adults, an initial dose of 800 mg followed by 400 mg in 6-8 hours and 400 mg on each of two consecutive days. For children a total dose representing 25 mg/kg is administered in 3 days as follows.
+
+- First dose: 10 mg base/kg (but not exceeding a single dose of 620 mg base).
+- Second dose: 5 mg base/kg (but not exceeding a single dose of 310 mg base) 6 hours after first dose.
+- Third dose: 5 mg base/kg 18 hours after second dose.
+- Fourth dose: 5 mg base/kg 24 hours after third dose.
+
",,,,"Generally Hydroxychloroquine Sulphate is well tolerated. However, few side effects like nausea, vomiting, stomach upset, loss of appetite, diarrhea, tiredness, weakness or headache and visual problem may occur the first several days.
","During pregnancy, this drug should be used only if clearly needed. Since small amounts of this medication are found in breast milk consult your doctor before medication.
","Children are especially sensitive to the 4-aminoquinoline compounds. Patients should be strongly warned to keep these drugs out of the reach of children. Opthalmologic examination requires in every 12 months.
",,"Symptoms of overdose consist of headache, drowsiness, visual disturbances, cardiovascular collapse, and convulsions, followed by sudden and early respiratory and cardiac arrest. Gastric lavage until the stomach is completely emptied.
",,,"Store below 30° C.
",9
+583,Hydroxocobalamin,hydroxocobalamin-583,https://medex.com.bd/attachments/fqPDaQDLkkznyAJyerLLwuFRRGmvW9/hydroxocobalamin-prescribing-information,Antidote preparations,Pernicious anemia,"Hydroxocobalamin is indicated for the treatment of known or suspected cyanide poisoning.
Identifying Patients with Cyanide Poisoning: Cyanide poisoning may result from inhalation, ingestion, or dermal exposure to various cyanide-containing compounds, including smoke from ... Read more
Hydroxocobalamin is indicated for the treatment of known or suspected cyanide poisoning.
Identifying Patients with Cyanide Poisoning: Cyanide poisoning may result from inhalation, ingestion, or dermal exposure to various cyanide-containing compounds, including smoke from closed-space fires. Sources of cyanide poisoning include hydrogen cyanide and its salts, cyanogenic plants, aliphatic nitriles, and prolonged exposure to sodium nitroprusside.
The presence and extent of cyanide poisoning are often initially unknown. There is no widely available, rapid, confirmatory cyanide blood test. Treatment decisions must be made on the basis of clinical history and signs and symptoms of cyanide intoxication. If clinical suspicion of cyanide poisoning is high, Hydroxocobalamin should be administered without delay.
In some settings, panic symptoms including tachypnea and vomiting may mimic early cyanide poisoning signs. The presence of altered mental status (e.g., confusion and disorientation) and/or mydriasis is suggestive of true cyanide poisoning although these signs can occur with other toxic exposures as well.
Smoke Inhalation: Not all smoke inhalation victims will have cyanide poisoning and may present with burns, trauma, and exposure to other toxic substances making a diagnosis of cyanide poisoning particularly difficult. Prior to administration of Hydroxocobalamin, smoke-inhalation victims should be assessed for the following:
+
+- Exposure to fire or smoke in an enclosed area
+- Presence of soot around the mouth, nose or oropharynx
+- Altered mental status
+
+Although hypotension is highly suggestive of cyanide poisoning, it is only present in a small percentage of cyanide-poisoned smoke inhalation victims. Also indicative of cyanide poisoning is a plasma lactate concentration ≥ 10 mmol/L (a value higher than that typically listed in the table of signs and symptoms of isolated cyanide poisoning because carbon monoxide associated with smoke inhalation also contributes to lactic acidemia). If cyanide poisoning is suspected, treatment should not be delayed to obtain a plasma lactate concentration.
Use with Other Cyanide Antidotes: Caution should be exercised when administering other cyanide antidotes simultaneously with Hydroxocobalamin, as the safety of co-administration has not been established. If a decision is made to administer another cyanide antidote with Hydroxocobalamin, these drugs should not be administered concurrently in the same intravenous line.
","Antidote preparations, Drugs for Megaloblastic Anemia
","Vitamin B12 with hydroxyl group complexed to cobalt which can be displaced by cyanide resulting in cyanocobaiamin that is renally excreted.
","Thirty mcg daily for 5 to 10 days followed by 100 to 200 mcg monthly injected intramuscularly. If the patient is critically ill, or has neurologic disease, an infectious disease or hyperthyroidism, considerably higher doses may be indicated. However, current data indicate that the optimum obtainable neurologic response may be expected with a dosage of vitamin B12 sufficient to produce good hematologic response. Children may be given a total of 1 to 5 mg over a period of 2 or more weeks in doses of 100 mcg, then 30 to 50 mcg every 4 weeks for maintenance.
",,"
+- history of interaction with ARI Sodium Iodide (II23) 1 -12 MBq (sodium iodide i-123)
+- ARI Sodium Iodide (1123) 100-750 MBq (sodium iodide i-123) arsenic trioxide
+- Chloracol (chloramphenicol) chloramphenicol
+- Chloromycetin (chloramphenicol)
+- Chloromycetin Sodium Succinate (chloramphenicol)
+- Hicon (sodium iodide-i-131) lodotope (sodium iodide-i-131) sodium iodide i-123 sodium iodide-i-131 Trisenox (arsenic trioxide)
+
","Hypersensitivity to any component of this medication.
","Mild transient diarrhea, itching, transitory exanthema, feeling of swelling of entire body, and anaphylaxis. A few patients may experience pain after injection of hydroxocobalamin.
","Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","The validity of diagnostic vitamin B12 or folic acid blood assays could be compromised by medications, and this should be considered before relying on such tests for therapy.
Vitamin B12 is not a substitute for folic acid and since it might improve folic acid deficient megaloblastic anemia, indiscriminate use of vitamin B12 could mask the true diagnosis.
Hypokalemia and thrombocytosis could occur upon conversion of severe megaloblastic to normal erythropoiesis with B12 therapy. Therefore, serum potassium levels and the platelet count should be monitored carefully during therapy.
Vitamin B12 deficiency may suppress the signs of polycythemia vera. Treatment with vitamin B12 may unmask this condition.
",,,,,"Should be stored in cool and dry place
",10
+381,Hydroquinone + Octyldimethyl + Dioxybenzone + Oxybenzone,hydroquinone-octyldimethyl-dioxybenzone-oxybenzone-381,,Sunblock Preparation,Senile lentigines,"Hydroquinone is indicated -
+
+- For the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines and other unwanted areas of melanin hyperpigmentation.
+- To reduce hyperpigmentation caused by photosensitization associated with inflammation or with the use of certain cosmetics.
+
","Sunblock Preparation
","Hydroquinone is a topical depigmentating agent used in hyperpigmentation conditions by suppressing melanocyte metabolic processes. It also increases melanin excretion from melanocytes and prevents its production.
Octyldimethyl P-aminobenzoate is used topically as a sunscreen. It is used to prevent sunburn, but unlikely to prevent drug-related or other photosensitivity reactions associated with UVA light.
Dioxybenzone (benzophenone-8) is an organic compound used in sunscreen to block UVB and short-wave UVA (ultraviolet) rays. It is a derivative of benzophenone. It is a yellow powder with a melting point of 68 °C. It is insoluble in water, but moderately soluble in ethanol and isopropanol.
Oxybenzone: Although benzophenones are primarily UV-B absorbers, oxybenzone absorbs well through UV-A II. Oxybenzone can be considered a broad-spectrum absorber. It significantly augments UV-B protection when used in a given formula.
","Adult: This cream should be applied to the affected area and rubbed in well twice daily or as directed by a physician. Most discolorations begin to lighten after 3 or 4 weeks of treatment but it may take longer. After desired bleaching, use only as needed to maintain results of treatment. After reduction of hyperpigmentation, use of sunscreen agents and/or protective clothing should continue on bleached skin to prevent repigmentation.
Children: Safety and efficacy in paediatric patients below the age of 12 years have not been established.
",,"There are no known drug interactions and none well documented.
","Hydroquinone is contraindicated to patients with prior history of hypersensitivity or allergic reaction to hydroquinone or other ingredients in the preparation. Sunburn or depilatory usage. Children <12 yr.
","Transient erythema, mild burning sensations; hyperpigmentation. Staining and corneal opacities. Tremors and convulsions after systemic absorption. Occasionally, hypersensitivity.
","Pregnancy Category-C. It is not known whether this cream can cause fetal harm when used topically on a pregnant woman or affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should be used in pregnant woman only when clearly indicated.
Lactation: It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by a nursing mother.
","Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin to check in 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, further treatment is not advised. If no bleaching or lightening effect is noted after 2 months of treatment, the medication should be discontinued.Contact with the eyes and lips should be avoided. Hydroquinone should not be applied to cut or abraded skin. Avoid contact with eyes and on abraded or sunburnt skin.
Avoid unnecessary exposure to sunlight. Limit application to area no larger than face and neck or hands and arms. Not advised to use when itching, vesicle formation, or excessive inflammation occurs. Discontinue application if there is no improvement after 2 mth of treatment.
",,,,,,9
+582,Hydroquinone,hydroquinone-582,https://medex.com.bd/attachments/xP3RY19u07byOgjnMBgedSyOuv3lH3/hydroquinone-prescribing-information,Hydroquinone Preparations,Senile lentigines,"Hydroquinone is indicated -
+
+- For the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines and other unwanted areas of melanin hyperpigmentation.
+- To reduce hyperpigmentation caused by photosensitization associated with inflammation or with the use of certain cosmetics.
+
","Hydroquinone Preparations
","Hydroquinone is a topical depigmentating agent that produces a reversible depigmentation of the skin by inhibiting enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine and suppressing melanocyte metabolic processes.
","Apply a thin film of Hydroquinone Cream to the effected area once daily, at least 30 minutes before bedtime. Gently wash the face and neck with a mild cleanser. Rinse and pat the skin dry. Apply Hydroquinone Cream to the hyperpigmented areas of melasma including about ½ inch of normal appearing skin surrounding each lesion. Rub lightly and uniformly into the skin.
Therapy should be discontinued when control is achieved. During the day, use a sunscreen of SPF 30, and wear protective clothing. Avoid sunlight exposure. Patients may use moisturizers and/or cosmetics during the day. Hydroquinone Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
",,,"Hydroquinone is contraindicated to patients with prior history of hypersensitivity or allergic reaction to hydroquinone or other ingredients in the preparation.
","No systemic adverse reactions have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur in which case the medication should be discontinued.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Lactation: It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by a nursing mother.
","Hydroquinone is a skin bleaching agent which may produce unwanted cosmetic effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this medication.
Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin to check in 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, further treatment is not advised. If no bleaching or lightening effect is noted after 2 months of treatment, the medication should be discontinued.
Contact with the eyes and lips should be avoided. Hydroquinone should not be applied to cut or abraded skin.
",,"There have been no systemic reactions from the use of topical hydroquinone. Some patients may experience a transient reddening of skin and mild burning sensation which does not preclude treatment.
",,,"Store between 20-25° C. Protect from light.
",10
+607,Inositol Nicotinate,inositol-nicotinate-607,https://medex.com.bd/attachments/4WzW6l9pHRS7smCTng9Zi84BCWjq9O/inositol-nicotinate-500-mg-tablets-prescribing-information,Nicotinic acid group,Raynaud's disease,"Inositol Nicotinate has a fairly broad range of therapeutic applications. The most well researched conditions include the hyperlipidemias, Raynaud's disease and intermittent claudication. Promising applications, which bear further investigation, include its use for stasis ulcers, dysmenorrhea, dermatitis herpetiformis, alcoholism, diabetes, cancer prevention and hypertension.
","Nicotinic acid group, Oral nutritional preparations
","Inositol Niacinate is a vasodilator and lipid-lowering agent. It improves circulation by releasing histamine, which causes the blood vessels to dilate and breaks up a protein needed for the clotting of blood. It also prevents the formation of lipids in the body, which helps to lower cholesterol and triglyceride levels.
","Recommended dosage for lipid-lowering and improving conditions related to peripheral vascular insufficiency ranges from 1500 mg to 4000 mg daily, in divided dosages of two to three times daily.
",,,"Inositol nicotinate is contraindicated to children, early stage of stroke & people who have recently had a heart attack. It should not be used if anyone is allergic to one or any of its ingredients
","The most common side effects are headache, rash, paraesthesia, dizziness, nausea and vomiting, flushing, excessive fluid retention in the body tissues, postural hypotension, fainting
","Pregnancy: There is no information available about the safety of this medicine during pregnancy, therefore it is not recommended for use during pregnancy, unless considered essential by your doctor. Seek medical advice from your doctor.
Lactation: There is no information available regarding the safety of this medicine during breastfeeding
","Cautions should be exercised in patients with angina not well controlled by medical treatment and decreased blood supply through the vessels of the brain (cerebrovascular insufficiency).
",,"Both acute and chronic toxicities have been reported from the use of highdose niacin. Reactions to niacin range from acute symptoms of flushing, pruritis, and GI complaints to chronic symptoms of hepatotoxicity, hyperuricemia, and impaired glucose tolerance. On the other hand, no adverse effects have been reported from the use of inositol hexaniacinate in dosages as high as four grams daily
",,,"Should be stored in cool and dry place
",10
+1552,Infliximab,infliximab-1552,https://medex.com.bd/attachments/17PACxgpnA2jsGFv1HmR2l4i7AGdGi/infliximab-prescribing-information,Targeted Cancer Therapy,Ulcerative colitis,"Crohn’s Disease:
+
+- Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
+- Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease.
... Read more
Crohn’s Disease:
+
+- Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
+- Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease.
+
+Pediatric Crohn’s Disease:
+
+- Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
+
+Ulcerative Colitis:
+
+- Reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
+
+Pediatric Ulcerative Colitis:
+
+- Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
+
+Rheumatoid Arthritis in combination with methotrexate:
+
+- Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active disease.
+
+Ankylosing Spondylitis:
+
+- Reducing signs and symptoms in patients with active disease.
+
+Psoriatic Arthritis:
+
+- Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function.
+
+Plaque Psoriasis:
+
+- Treatment of adult patients with chronic severe (i.e., extensive and /or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.
+
","Targeted Cancer Therapy
","Infliximab neutralizes the biological activity of TNFα by binding with high affinity to the soluble and transmembrane forms of TNFα and inhibits binding of TNFα with its receptors. Infliximab does not neutralize TNFα (lymphotoxin-α), a related cytokine that utilizes the same receptors as TNFα. Biological activities attributed to TNFα include: induction of pro inflammatory cytokines such as interleukins (IL) 1 and 6, enhancement of leukocyte migration by increasing endothelial layer permeability and expression of adhesion molecules by endothelial cells and leukocytes, activation of neutrophil and eosinophil functional activity, induction of acute phase reactants and other liver proteins, as well as tissue degrading enzymes produced by synoviocytes and/or chondrocytes. Cells expressing transmembrane TNFα bound by infliximab can be lysed in vitro or in vivo. Infliximab inhibits the functional activity of TNFα in a wide variety of in vitro bioassays utilizing human fibroblasts, endothelial cells, neutrophils, B and T lymphocytes and epithelial cells. The relationship of these biological response markers to the mechanism(s) by which Infliximab exerts its clinical effects is unknown. Anti-TNFα antibodies reduce disease activity in the cotton-top tamarin colitis model, and decrease synovitis and joint erosions in a murine model of collagen-induced arthritis. Infliximab prevents disease in transgenic mice that develop polyarthritis as a result of constitutive expression of human TNFα, and when administered after disease onset, allows eroded joints to heal.
","Crohn’s Disease: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some adult patients who initially respond to treatment may benefit from increasing the dose to 10 mg/kg if they later lose their response.
Pediatric Crohn’s Disease: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Ulcerative Colitis: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Pediatric Ulcerative Colitis: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Rheumatoid Arthritis: In conjunction with methotrexate, 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some patients may benefit from increasing the dose up to 10
mg/kg or treating as often as every 4 weeks.
Ankylosing Spondylitis: 5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks.
Psoriatic Arthritis and Plaque Psoriasis: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
","Infliximab is administered by intravenous infusion over a period of not less than 2 hours.
","Use with anakinra or abatacept- increased risk of serious infections
","Infliximab doses >5 mg/kg in moderate to severe heart failure. Previous severe hypersensitivity reaction to Infliximab or known hypersensitivity to inactive components of Infliximab or to any murine proteins.
","Most common adverse reactions (>10%)- infections (e.g. upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.
","Pregnancy Category B. It is not known whether Infliximab can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
It is not known whether Infliximab is excreted in human milk or absorbed systemically after ingestion. Because many drugs and immunoglobulins are excreted in human milk, and because of the potential for adverse reactions in nursing infants from Infliximab, women should not breast-feed their infants while taking Infliximab.
","Serious infections- do not give Infliximab during an active infection. If an infection develops, monitor carefully and stop Infliximab if infection becomes serious.
Invasive fungal infections- for patients who develop a systemic illness on Infliximab, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic
Malignancies- the incidence of malignancies including lymphoma was greater in Infliximab treated patients than in controls. Due to the risk of HSTCL carefully assess the risk/benefit especially if the patient has Crohn’s disease or ulcerative colitis, is male, and is receiving azathioprine or 6-mercaptopurine treatment.
Hepatitis B virus reactivation- test for HBV infection before starting Infliximab. Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop Infliximab and begin anti-viral therapy.
Hepatotoxicity- rare severe hepatic reactions, some fatal or
necessitating liver transplantation. Stop Infliximab in cases of jaundice and/or marked liver enzyme elevations.
Heart failure- new onset or worsening symptoms may occur.
Cytopenias- advise patients to seek immediate medical attention if signs and symptoms develop, and consider stopping Infliximab.
Hypersensitivity- serious infusion reactions including anaphylaxis or serum sickness-like reactions may occur.
Demyelinating disease- exacerbation or new onset may occur.
Lupus-like syndrome- stop Infliximab if syndrome develops.
Live vaccines or therapeutic infectious agents- should not be given with Infliximab. Bring pediatric patients
","Pediatric Use: Infliximab has not been studied in children with Crohn’s disease or ulcerative colitis<6 years of age.
",,,,"Infliximab must be refrigerated at 2ºC to 8ºC. Do not use Infliximab beyond the expiration date (Exp) located on the carton and the vial. This product contains no preservative.
",12
+1802,Indomethacin (Rectal),indomethacin-rectal-1802,https://medex.com.bd/attachments/XoYkfpcKEPaORblFvwIPbyAylhChqG/indomethacin-rectal-prescribing-information,Drugs for Osteoarthritis,Rheumatoid arthritis,"Indomethacin is indicated for the treatment of rheumatoid arthritis, ankylosing spondylitis, osteoarthritis (degenerative joint disease), gout, acute non-articular rheumatism (bursitis, synovitis, tendinitis).
","Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) having properties of antipyretic and analgesic effects. A great number of pharmacological studies have proved that Indomethacin has strong anti-inflammatory, analgesic and antipyretic properties. Unlike the corticosteroids, the effect of Indomethacin is not related to the pituitary gland or the adrenals.
","100 mg at night and in the morning if required.
",,"It may interact with anticoagulants, lithium, diuretics, Beta-blockers, diflunisal, aspirin, probenecid and sulfonylureas.
","It is contraindicated in previously hypersensitive patient.
","Headache, usually in the morning and mild vertigo may occur during the early weeks of therapy. These symptoms are transient and usually disappear with continued use or by reduction of the dose. Gastrointestinal reactions such as nausea, vomiting, diarrhea, epigastric and abdominal pain are often due to large doses of the drug and disappear when the dose is reduced.
","Not recommended for pregnant women, because at the present time clinical studies are insufficient.
",,"Use in children: Not recommended for children.
",,,,"Keep in a cool place, away from light & moisture. Keep out of the reach of children.
",10
+605,Indomethacin (Oral),indomethacin-oral-605,https://medex.com.bd/attachments/65JXWhXgdXqtHW82ptAFFePHk1tAPP/indomethacin-oral-25-mg-capsule-prescribing-information,Drugs for Osteoarthritis,Rheumatoid arthritis,"Indomethacin is indicated in-
+
+- Rheumatoid arthritis
+- Ankylosing spondylitis
+- Osteoarthritis (degenerative joint disease)
+- Gout
+- Acute non-articular rheumatism (bursitis, synovitis, tendinitis).
+
","Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Indomethacin is NSAID having property of antipyretic and analgesic effect. A great number of pharmacological studies have proved that Indomethacin has strong anti-inflammatory, analgesic, and antipyretic properties. Unlike the corticosteriods, the effect of Indomethacin is not related to the pituitary gland or the adrenals. Indomethacin is absorbed promptly following oral administration and peak plasma levels occur within 2 hours. Approximately two thirds of this amount is excreted in the urine and the remainder is excreted in the feces. About 90% of a single dose is excreted in 24-48 hours. In a number of controlled clinical trials, Indomethacin has proved to be of great value in the treatment of rheumatic diseases, It relieves pain, reduces joints swelling edema and improves joint mobility.
","75 mg sustained-release capsule:
+
+- Rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis (degenerative joint disease): The initial dose is 75 mg sustained-release capsule once daily. If severe then twice daily is required.
+- Acute attacks of gout: May control with a dose of 75 mg sustained-release capsule twice daily.
+- Acute non-articular rheumatism (bursitis, synovitis, tendinitis): 1-2 sustained-release capsule daily according to the severity of this case.
+
+25 mg capsule:
+
+- Rheumatic diseases: 50-200 mg daily in divided doses
+- Acute gout: 150-200 mg daily in divided doses
+- Dysmenorrhea: up to 75 mg daily
+
",,"It may interact with anticoagulants, Lithium, diuretics, antihypertensive drugs, diflunisal and sulfonylureas.
","Indomethacin is contraindicated in patients with ulcer, gastritis, active ulcerative colitis, and it should be used with caution in patients with a history of these disorders. In these cases, administration of Indomethacin suppositories should be preferred. It is also contraindicated in the previously hypersensitive patients.
","Headaches, usually in the morning and kild vertigo may occur during the early weeks of therapy. These symptoms are transient and usually disappear with continued use or by reduction of the dose. Rare case of mild psychic disturbances was also reported which subsided after few days of treatment, Gastrointestinal reactions such as nausea, vomiting, diarrhoea, epigastric and abdominal pain are often due to large doses of the drug and disappear when the dose is reduced. Administration of the capsule immediately after meals with an antacid it necessary, minimize the frequency and the severity of these untoward effects.
",,"Indomethacin capsule should be used with caution with psychiatric problems, epilepsy or parkinsonism since the drug may aggravate these conditions. It is not recommended for pregnant women, because at the present time clinical studies are insufficient. Indomethacin is not given nomally in neonates except when used to assist closure of a patent ductus arteriosus.
",,,,,"Store in a cool and dry place protected from light. Keep out of the reach of children.
",9
+604,Indapamide + Perindopril Arginine,indapamide-perindopril-arginine-604,https://medex.com.bd/attachments/Hthdc8CAkpPU6nyRKdqbt7ViM5FISI/indapamide-perindopril-arginine-prescribing-information,Combined antihypertensive preparations,Ischaemic heart disease,"Indapamide & Perindopril combination is indicated in essential hypertension.
","Combined antihypertensive preparations
","Perindopril is an ACE inhibitor, which acts by inhibiting the conversion of angiotensin I to angiotensin II, reducing the activity of the sympathetic nervous system and inhibiting enzyme kininase, which is involved in the conversion of bradykinin and other substances.
Indapamide is a sulfonamide derivative with an indole ring. It inhibits the reabsorption of sodium in the cortical dilution segment, thus increasing urinary output, resulting in an antihypertensive effect.
","2 mg perindopril / 0.625 mg indapamide is indicated for the initial treatment of mild to moderate essential hypertension.
4 mg perindopril / 1.25 mg indapamide and 8 mg perindopril / 2.5 mg indapamide) are indicated in the treatment of mild to moderate essential hypertension in patients for whom combination therapy is appropriate.
4 mg perindopril / 1.25 mg indapamide and 8 mg perindopril / 2.5 mg indapamide are not indicated for initial therapy. Patients in whom perindopril and indapamide are initiated simultaneously can develop symptomatic hypotension.
Patients should be titrated on the individual drugs. If the fixed combination represents the dosage determined by this titration, the use of (4 mg perindopril / 1.25 mg indapamide) and (8 mg perindopril / 2.5 mg indapamide) may prove to be more convenient in the management of patients. If during maintenance therapy dosage adjustment is necessary, it is advisable to use individual drugs
The safety and efficacy of perindopril / indapamide in renovascular hypertension and in congestive heart failure have not been established and therefore, their use in this condition is not recommended.
Geriatrics (> 65 years of age): Although the blood pressure response and safety profile of in patients >65 years old were comparable to those of the younger adult patients, greater sensitivity of some elderly patients cannot be ruled out.
Pediatrics: The safety and effectiveness of in children have not been established. Its use in this age group, therefore, is not recommended.
",,"Increased risk of lithium toxicity. May cause and potentiate orthostatic hypotension when used with alcohol, barbiturates, neuroleptics, narcotics or other antihypertensives. Increased risk of acute renal insufficiency in dehydrated patients when used with systemic NSAIDs or high dose salicylates. May increase risk of hypoglycaemia in patients on concurrent treatment with hypoglycaemic sulfonamides/insulin. Concurrent use with baclofen may potentiate antihypertensive effect. May reduce antihypertensive effect when used with corticosteroids or tetracosactide. Increased risk of hyperkalaemia when used with potassium-sparing diuretics or potassium supplements. May increase hypotensive effect of certain anaesthetic drugs. Increased risk of leucopenia when used with allopurinol, immunosuppressants, procainamide or systemic corticosteoids. Additive hypotensive effect when used with other antihypertensives.
","Absolute: Known allergy to perindopril Erbumine, indapamide, or sulfonamides; history of Quincke's edema linked to previous ACE inhibitor therapy; severe renal failure; serious liver disorder; hypokalemia; pregnancy; lactation.
Relative: Combination therapy with lithium, potassium salts, potassium-sparing diuretics, and certain medicines which can cause heart rhythm disorders.
","Asthenia, dizziness, headache, mood swings and/or sleep disturbances, cramps, hypotension, allergic reactions, skin rashes, gastrointestinal disorders, dry cough, dry mouth, risk of dehydration in the elderly and in patients suffering from heart failure; changes in blood test results may occur.
","There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
","Disorders of electrolyte balance, diabetes, gout, hypotension, or strict sodium-free diets, heart or renal failure, atherosclerosis, renal artery stenosis, elderly.
","Renal failure:
+
+- Creatinine clearance (CrCl) >30 ml/min: No dosage modification.
+- Creatinine clearance (CrCl) <30 ml/min: Treatment contraindicated.
+
","Symptoms include hypotension, nausea, vomiting, cramps, dizziness, sleepiness mental confusion, oliguria which may progress to anuria. Salt and water disturbances (low sodium levels, low potassium levels) may also occur. Gastric lavage or administration of activated charcoal may be used to remove the ingested drug. Monitor and maintain fluid and electrolyte balance.
",,,"Store below 30° C.
",12
+2032,Indapamide + Amlodipine,indapamide-amlodipine-2032,https://medex.com.bd/attachments/aCroY6nCfhNbadTu9tbIOsAgq9DDSA/indapamide-amlodipine-prescribing-information,Combined antihypertensive preparations,Essential hypertension,"This is indicated as substitution therapy for treatment of essential hypertension in patients already controlled with indapamide and amlodipine given concurrently at the same dose level.
","Combined antihypertensive preparations
","Indapamide is a sulphonamide derivative with an indole ring, pharmacologically related to thiazide diuretics, which acts by inhibiting the reabsorption of sodium in the cortical dilution segment. It increases the urinary excretion of sodium and chlorides and, to a lesser extent, the excretion of potassium and magnesium, thereby increasing urine output and having an antihypertensive action.
Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle. The mechanism of the antihypertensive action of amlodipine is due to a direct relaxant effect on vascular smooth muscle.
","One tablet per day as single dose, preferably to be taken in the morning, to be swallowed whole with water and not chewed. The fixed dose combination is not suitable for initiation therapy. If a change of the posology is required, titration should be done with the individual components.
Pediatric population: The safety and efficacy of this medicine in children and adolescents have not been established. No data are available.
Patients with renal impairment: In severe renal impairment (creatinine clearance below 30 ml/min), treatment is contraindicated. In patients with mild to moderate renal impairment, no dose adjustment is needed. Older people can be treated with this medicine according to renal function.
Patients with hepatic impairment: In severe hepatic impairment, treatment is contraindicated. Dosage recommendations of amlodipine have not been established in patients with mild to moderate hepatic impairment; therefore dose selection should be cautious and should start at the lower end of the dosing range
",,,"
+- hypersensitivity to the active substances, to other sulphonamides, to dihydropyridine derivatives or to
+- any of the excipients
+- severe renal failure (creatinine clearance below 30 ml/min)
+- hepatic encephalopathy or severe impairment of liver function
+- hypokalaemia
+- lactation
+- severe hypotension
+- shock (including cardiogenic shock)
+- obstruction of the outflow tract of the left ventricle (e.g., high-grade aortic stenosis)
+- hemodynamically unstable heart failure after acute myocardial infarction
+
","The most commonly reported adverse reactions with indapamide and amlodipine given separately are somnolence, dizziness, headache, palpitations, flushing, abdominal pain, nausea, ankle swelling, oedema and fatigue.
","If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. This medicine is not recommended during pregnancy. When a pregnancy is planned or confirmed, the switch to an alternative treatment should be initiated as soon as possible. You must not take this medicine if you are breastfeeding. Tell your doctor immediately if you are breastfeeding or about to start breastfeeding.
","You should inform your doctor if you have or have had any of the following conditions:
+
+- recent heart attack,
+- if you have heart failure, any heart rhythm problems, if you have coronary artery disease (heart disease caused by poor blood flow in the blood vessels of the heart),
+- if you have problems with your kidneys,
+- severe increase in blood pressure (hypertensive crisis),
+- you are elderly and your dose needs to be increased,
+- if you take other medicines,
+- if you are malnourished,
+- if you have liver problems,
+- if you have diabetes,
+- if you suffer from gout,
+- if you need to have a test to check how well your parathyroid gland is working,
+- if you had photosensitivity reactions.
+
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+603,Indapamide,indapamide-603,https://medex.com.bd/attachments/fbP58OrnMNakPT7qaphUFiwLiIzVD8/indapamide-prescribing-information,Thiazide diuretics & related drugs,Oedema,"Indapamide is indicated in the treatment of essential hypertension . It is effective in treating hypertension in patients with renal function impairment, although its diuretic effect is reduced. Indapamide is also indicated for the treatment of salt and fluid retention associated with congestive heart failure.
","Thiazide diuretics & related drugs
","Indapamide is a diuretic antihypertensive. It appears to cause vasodilation, probably by inhibiting the passage of calcium and other ions (sodium, potassium) across membranes. It has an extra-renal antihypertensive action resulting in a decrease in vascular hyperreactivity and a reduction in total peripheral and arteriolar resistance.
","One tablet daily preferably in the morning. In more sever case Indapamide can be combine with other categories of anti-hypertensive agent. The safety and effectiveness in pediatric patients have not been established
",,"Other antihypertensive: Indapamide may add to or potentiate the action of other antihypertensive drugs.
Norepinephrine: Indapamide like thiazides, may decrease arterial responsiveness to norepinephrine.
Lithium: In general, diuretics should not be given concomitantly with lithium because they reduce its renal clearance and add a high risk of lithium toxicity.
","This drug must not be taken in the following conditions:
+
+- Hypersensitivity to sulfonamides
+- Severe renal failure
+- Hepatic encephalopathy or severe hepatic failure
+- Hypokalaemia
+
","Side effects of Indapamide include headache, anorexia, gastric irritation,nausea, vomiting, constipation, diarrhoea etc.
","There are no adequate and well-controlled studies in pregnant women and so Indapamide is not recommended. Mothers taking Indapamide should not breast feed.
","Monitoring of potassium and uric acid serum levels is recommended, especially in subjects with a predisposition or sensitivity to hypokalemia and in patients with gout. Although no allergic manifestations have been reported during clinical trials, patients with a history of allergy to sulfonamide derivatives should be closely monitored.
",,"Symptoms: These could include: allergies, skin rashes, epigastric pain, nausea, photosensitivity, dizziness, weakness and paraesthesia.
Treatment: Treatment is supportive and symptomatic, directed at correcting the electrolyte abnormalities.
",,,"Store in a cool and dry place. Protect from light and moisture.
",11
+601,Indacaterol Maleate,indacaterol-maleate-601,https://medex.com.bd/attachments/a9ilXbW6kCLl8vOQPnwuPIPNYoxFXL/indacaterol-maleate-75-mcg-inhalation-powder-prescribing-information,Long-acting selective β-adrenoceptor stimulants,COPD,"Indacaterol is indicated for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
","Long-acting selective β-adrenoceptor stimulants
",,"Indacaterol capsules must not be swallowed as the intended effects on the lungs will not be obtained. The contents of Indacaterol capsules are only for oral inhalation and should only be used with the device.
The recommended dosage of Indacaterol is the once-daily inhalation of the contents of one 75 mcg, 150 mcg, 300 mcg Indacaterol capsule using the device.
Indacaterol should be administered once daily every day at the same time of the day by the orally inhaled route only. If a dose is missed, the next dose should be taken as soon as it is remembered. Do not use Indacaterol more than one time every 24 hours.
No dosage adjustment is required for geriatric patients, patients with mild and moderate hepatic impairment, or renally impaired patients. No data are available for subjects with severe hepatic impairment. Indacaterol is not indicated for use in the pediatric population. Safety and efficacy have not been established.
",,"Indacaterol shows interaction with Adrenergic Drugs, Xanthine Derivatives, Steroids, or Diuretics. Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of Indacaterol. The ECG changes or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by β2-agonists. Indacaterol, as with other β2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval. β-adrenergic receptor antagonists (beta-blockers) and Indacaterol may interfere with the effect of each other when administered concurrently.
","All LABA are contraindicated in patients with asthma without use of a long-term asthma control medication. Indacaterol powder is not indicated for the treatment of asthma. Indacaterol is contraindicated in patients with a history of hypersensitivity to Indacaterol or to any of the ingredients.
","The most commonly reported adverse effects were cough, nasopharyngitis, headache, nausea, oropharyngeal pain. Some other also reported of hypersensitivity reactions, paradoxical bronchospasm, tachycardia, pruritis and dizziness.
","Pregnancy Category C. There are no adequate and well-controlled studies with Indacaterol powder in pregnant women. Indacaterol powder should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known that the active component of Indacaterol powder, Indacaterol is excreted in human milk. Because many drugs are excreted in human milk and because Indacaterol has been detected in the milk of lactating rats, caution should be exercised when Indacaterol powder is administered to nursing women.
","Rarely, serious (sometimes fatal) breathing problems have happened to people with asthma using a long-acting inhaled beta agonist (salmeterol). Since Indacaterol is similar to salmeterol, it might cause these serious breathing problems. Indacaterol has not been shown to be safe or effective to treat asthma and is not approved for this use.
",,"The expected signs and symptoms associated with over dosage of Indacaterol powder are those of excessive beta-adrenergic stimulation and occurrence or exaggeration of any of the signs and symptoms, e.g., angina, hypertension or hypotension, tachycardia, with rates up to 200 bpm, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis and insomnia. As with all inhaled sympathomimetic medications, cardiac arrest and even death may be associated with an over dose of Indacaterol powder.
",,,"Indacaterol capsules must always be stored in the blister, and only removed immediately before use. Keep in a cool & dry place. Keep out of the reach of children.
",10
+2059,Indacaterol + Glycopyrronium + Mometasone Furoate,indacaterol-glycopyrronium-mometasone-furoate-2059,https://medex.com.bd/attachments/JGzKcSHRwxRHSo7w8nefBzKtNa8LO0/indacaterol-glycopyrronium-mometasone-furoate-prescribing-information,,,"This is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta 2-agonist and a medium or high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous 12 months. This is not indicated for the relief of acute bronchospasm.
",,"Indacaterol: Indacaterol is a long-acting beta 2-adrenergic agonist for once-daily administration. The pharmacological effects of beta 2 -adrenoceptor agonists, including indacaterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3’, 5’-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle. In vitro studies have shown that indacaterol is a weak partial agonist at beta 1 -receptors with a potency more than 24-fold greater at beta 2 -receptors compared to beta 1-receptors and is a full agonist at beta 3 -receptors with a potency 20-fold greater at beta 2-receptors compared to beta 3-receptors. When inhaled, indacaterol acts locally in the lung as a bronchodilator. Indacaterol is a nearly full agonist at the human beta 2-adrenergic receptor with nanomolar potency. In isolated human bronchus, indacaterol has a rapid onset of action and a long duration of action. Although beta 2-adrenergic receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta 1-receptors are the predominant receptors in the human heart, there are also beta 2-adrenergic receptors in the human heart comprising 10% to 50% of the total adrenergic receptors. The precise function of beta 2-adrenergic receptors in the heart is not known, but their presence raises the possibility that even highly selective beta 2-adrenergic agonists may have cardiac effects.
Glycopyrronium: Glycopyrronium is an inhaled long-acting muscarinic receptor antagonist (anti-cholinergic). Glycopyrronium works by blocking the broncho-constrictor action of acetylcholine on airway smooth muscle cells thereby dilating the airways. Of the five known muscarinic receptor subtypes (M1-5), only subtypes M1-3 have a defined physiological function in the human lung. Glycopyrronium is a high affinity muscarinic receptor antagonist of these three receptor subtypes. It demonstrated 4- to 5-fold selectivity for the human M3 and M1 receptors over the human M2 receptor in competition binding studies. It has a rapid onset of action, as evidenced by observed receptor association/dissociation kinetic parameters and by the onset of action after inhalation in clinical studies. The long duration of action can be partly attributed to sustained drug concentrations in the lungs as reflected by the prolonged terminal elimination half-life of glycopyrronium after inhalation via the inhaler in contrast to the half-life after intravenous administration.
Mometasone furoate: Mometasone furoate is a synthetic corticosteroid with high affinity for glucocorticoid receptors and local anti-inflammatory properties. Studies in asthmatic patients have demonstrated that inhaled mometasone furoate provides a favorable ratio of pulmonary to systemic activity. It is likely that much of the mechanism for the effects of mometasone furoate lies in its ability to inhibit the release of mediators of the inflammatory cascade. In vitro, mometasone furoate inhibits the release of leukotrienes (LT) from leukocytes of allergic patients. In cell culture, mometasone furoate demonstrated high potency in inhibition of synthesis and release of IL-1, IL-5, IL-6 and TNF-alpha. It is also a potent inhibitor of LT production and an extremely potent inhibitor of the production of the Th2 cytokines, IL-4 and IL-5, from human CD4+ T-cells.
","Patients should be made aware that inhalation capsules should be used regularly, even when asymptomatic.
When treating patients with asthma, physicians should only prescribe inhalation capsules for patients not adequately controlled on a long-term asthma control medication containing a LABA and a medium or high dose inhaled corticosteroid and who experienced one or more asthma exacerbations in the previous year.
As with other inhaled drugs containing beta 2-adrenergic agents, inhalation capsules should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA, as an overdose may result. When beginning treatment with inhalation capsules patients who have been taking rapid onset, short duration, inhaled beta 2-agonists on a regular basis (e.g., q.i.d) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief if they develop acute respiratory symptoms while taking inhalation capsules.
It is crucial to inform patients that inhalation capsules should not be used to treat acute symptoms of asthma. Patients should be prescribed a rapid onset, short duration inhaled bronchodilator (e.g., salbutamol) to relieve acute symptoms such as shortness of breath and advised to have this available for use at all times.
The recommended dose for patients 18 years of age and older: Inhalation of the content of 150/50/160 micrograms one capsule once daily in patients not adequately controlled with a combination of a long-acting beta 2-agonist and a medium or high dose of an inhaled corticosteroid. The maximum recommended dose is 150/50/160 micrograms once daily.
",,,"This is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
",,"Pregnant Women: There are insufficient data on the use of indacaterol, glycopyrronium and mometasone furoate in pregnant women to inform a drug-associated risk. Indacaterol and glycopyrronium were not teratogenic in rats and rabbits following subcutaneous or inhalation administration respectively. In animal reproduction studies with pregnant mice, rats and rabbits, mometasone furoate caused increased fetal malformations and decreased fetal survival and growth. This should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the fetus.
Breast-feeding: There is no information available on the presence of indacaterol, glycopyrronium or mometasone in human milk, on the effects on a breastfed child, or on the effects on milk production. Other inhaled corticosteroids, similar to mometasone furoate, are transferred into human milk. Indacaterol, glycopyrronium and mometasone furoate have been detected in the milk of lactating rats. Glycopyrronium reached up to 10-fold higher concentrations in the milk of lactating rats than in the blood of the dam after intravenous administration.
",,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",6
+1676,Indacaterol + Glycopyrronium,indacaterol-glycopyrronium-1676,https://medex.com.bd/attachments/05O474v5IplSuXEzGY8ZavGz7x7hDh/indacaterol-glycopyrronium-prescribing-information,Combined bronchodilators,COPD,"Indacaterol & Glycopyrronium combination is indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
","Combined bronchodilators
","Indacaterol Maleate is a selective β2-adrenergic agonist. Its chemical name is (R)-5-[2-(5,6-Diethylindan-2-ylamino)-1-hydroxyethyl]-8 hydroxy-1H-quinolin-2-one maleate. Indacaterol Maleate has a molecular weight of 508.56 and its empirical formula is C24H28N2O3.C4H4O4. Indacaterol Maleate is a white to very slightly grayish or very slightly yellowish powder. Indacaterol Maleate is freely soluble in N methylpyrrolidone and dimethylformamide, slightly soluble in methanol, ethanol, propylene glycol and polyethylene glycol 400, very slightly soluble in water, isopropyl alcohol and practically insoluble in 0.9% sodium chloride in water, ethyl acetate and n-octanol. Glycopyrronium is a long-acting, specific antimuscarinic agent, in clinical medicine often called an anticholinergic. It has a similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, inhibition of M3-receptors at the smooth muscle results in relaxation. The high potency and slow receptor dissociation found its clinical correlate in significant and long-acting bronchodilation in patients with COPD.
","Indacaterol 110 µg and Glycopyrronium 50 µg: The recommended dosage of Indacaterol & Glycopyrronium combination DPI is inhalation of the contents of one capsule once daily with the ConviHaler device.
Indacaterol 27.5 µg & Glycopyrronium 15.6 µg: The recommended dosage of Indacaterol & Glycopyrronium combination DPI is inhalation of the contents of one capsule twice daily with the ConviHaler device.
",,"Adrenergic drugs, xanthine derivatives, steroids, or diuretics, non-potassium sparing diuretics, monoamine oxidase inhibitors, tricyclic antidepressants, QTc prolonging drugs, beta-blockers, inhibitors of cytochrome P450 3A4 and P-gp efflux transporter may interact with Indacaterol.
",,"Inhaled medicines may cause inhalation-induced bronchospasm, dehydration, dry mouth, constipation dizziness, insomnia, skin and subcutaneous tissue disorders & immune system disorders.
","There is a limited amount of data from the use of Indacaterol and Glycopyrronium combination in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant doses. Indacaterol and Glycopyrronium combination should not be used in pregnant or nursing women unless the expected benefit outweighs any possible risk to the unborn child or the infant.
","Indacaterol and Glycopyrronium combination is as a twice daily maintenance bronchodilator should not be used for the initial treatment of acute episodes of bronchospasm, i.e. rescue therapy. Immediate hypersensitivity reactions may occur after administration of Indacaterol and Glycopyrronium combination inhalation powder. As with other anticholinergic drugs, Glycopyrronium should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction.
",,"An overdose of indacaterol is likely to lead to exaggerated effects typical of beta2-adrenergic stimulants, i.e. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalaemia and hyperglycaemia. High doses of Glycopyrronium may lead to anticholinergic signs and symptoms.
",,,"Do not store above 30°C. Keep away from light and out of the reach of children. Protect from freezing. Insert the ConviCap in the ConviHaler just prior to use to protect from deterioration by moisture.
",10
+1210,Inactivated Polio Vaccine,inactivated-polio-vaccine-1210,https://medex.com.bd/attachments/a6o6q15ESca7VzzIZyBxVsttWduEp0/inactivated-polio-vaccine-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Active immunisation against Poliomyelitis,"Primary active immunization: Poliomyelitis vaccine is indicated for active immunization of infants, children and adults for the prevention of poliomyelitis caused by poliovirus types 1, 2 and 3. It is recommended that all infants, unimmunized children and adolescents not previously ... Read more
Primary active immunization: Poliomyelitis vaccine is indicated for active immunization of infants, children and adults for the prevention of poliomyelitis caused by poliovirus types 1, 2 and 3. It is recommended that all infants, unimmunized children and adolescents not previously immunized be vaccinated routinely against paralytic poliomyelitis.
Immune deficiency and altered immune status: Patients with immuno-deficiencies status are at a greater risk of developing paralysis when exposed to poliovirus. Oral polio vaccine is contraindicated in such a patient.
Altered immune states due to disease and compromised immune system due to treatment with corticosteroids should be immunized with IPV according to the dosage schedule. Patients with altered immune status may or may not develop protective immune response after administration of IPV.
","Vaccines, Anti-sera & Immunoglobulin
","Inactivated poliovirus vaccine induces the production of neutralizing antibodies against each type of virus. Administration of the second dose results in rapid increase of antibody levels indicating existance of immunological memory. IPV is able to induce secretory antibody (IgA) produced in the pharynx and gut and reduces pharyngeal excretion of poliovirus.
","Primary dose schedule of polio vaccine (IPV) along with OPV:
+
+- At birth- OPV;
+- At 6th week- IPV+OPV;
+- At 10th week- IPV+OPV;
+- At 14th week- IPV+OPV;
+- At 15-18th months- IPV+OPV;
+- At 4-5 years- OPV.
+
+Polio vaccine (IPV) alone:
+
+- 1st dose- at 2 months
+- 2nd dose- at 4 months
+- 3rd dose- at 6-18 months
+- Booster dose- at 4-6 years.
+
","After preparation of the injection site, immediately administer 0.5 ml of polio vaccine intramuscularly. For patients with thrombocytopenia or bleeding disorders, the injection should be given subcutaneously. Lateral aspect of the mid thigh is the preferred site in infants and small children. In older children and adults, it should be administered in deltoid area. Shake well before use. Do not administer vaccine intravenously.
",,"Polio vaccine should not be administered to subjects with known hypersensitivity to any component of the vaccine, or to subjects that have shown any signs of hypersensitivity after previous administration of IPV vaccine. Vaccination of persons with an acute, febrile illness should be deferred until recovery.
","Following vaccine administration, a mild erythematous reaction and induration has been observed at the site of injection, in rare cases. In a few instances, the erythema may be accompanied by moderate fever.
","Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
",,,,,,"Keep refrigerated (between +2°C and +8°C). Protect from light. Do not freeze.
Shelf-Life: 36 months.
",9
+606,Inactivated Influenza Vaccine,inactivated-influenza-vaccine-606,https://medex.com.bd/attachments/CElieIhfdho23WQwF0arrB3in7bvLo/inactivated-influenza-vaccine-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Influenza A and B,"Prophylaxis of influenza (flu), especially in those who run an increased risk of associated complications. The use of Inactivated Influenza Vaccine should be based on official recommendations.
","Vaccines, Anti-sera & Immunoglobulin
",,"Dosage:
+
+- Adults and children over 36 months of age: 0.5ml
+- Children from 6 to 35 months of age: clinical data are limited. Doses of 0.25 ml or 0.5 ml have been used.
+
+
Administrations: For children who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks. If half a dose (0.25 ml) is to be administered, discard half the contained volume (up to the mark indicated on the syringe barrel), before injection. Immunisation should be carried out by intramuscular or deep subcutaneous injection. The vaccine should be allowed to reach room temperature before use. Shake before use. Seroprotection is generally obtained within 2 to 3 weeks. The duration of postvaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually 6-12 months.
",,"Inactivated Influenza Vaccine may be given at the same time as other vaccines. Immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified. The immunological response may be diminished if the patient is undergoing immunosuppressant treatment. Following influenza vaccination, false positive results in serology tests using the ELISA method (blood test) to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed. The Western Blot technique disproves the false-positive ELISA results. The transient false positive reactions could be due to the IgM response by the vaccine.
","Hypersensitivity to the active substances, to any of the excipients and to residues, e.g. eggs, chicken proteins, such as ovalbumin. The vaccine may contain residues of the following substances, e.g. kanamycin and neomycin sulphate, formaldehyde, cetyltrimethylammonium bromide (CTAB) and polysorbate 80. Immunisation shall be postponed in patients with febrile illness or acute infection.
",,"The limited data from vaccinations in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine. The use of this vaccine may be considered from the second trimester of pregnancy. For pregnant women with medical conditions that increase their risk of complications from influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy. Inactivated Influenza Vaccine may be used during lactation.
","Antibody response in patients with endogenous (due to illness) or iatrogenic (due to medicine) immunosuppression (poor immune response) may be insufficient. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. Inactivated Influenza Vaccine should under no circumstances be administered intravascularly.
",,,,,"Inactivated Influenza Vaccine must be stored in a refrigerator (2°C-8°C). Do not freeze. Keep the syringe in the outer carton in order to protect from light. Any unused product or waste material should be disposed of in accordance with local requirements.
",8
+1509,Inactivated Hepatitis A vaccine,inactivated-hepatitis-a-vaccine-1509,https://medex.com.bd/attachments/oOusZ5pKs64nFmi5PmW9bYKPPsoZ5U/inactivated-hepatitis-a-vaccine-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Active immunisation against hepatitis A,"The vaccine is indicated for the active immunization of adults and children from 12 months of age against infection caused by Hepatitis A virus.
","Vaccines, Anti-sera & Immunoglobulin
","The hepatitis A virus belongs to the picornavirus family. It is one of several hepatitis viruses that cause systemic disease with pathology in the liver. The incubation period for hepatitis A averages 28 days (range: 15 to 50 days). The course of hepatitis A infection is extremely variable, ranging from asymptomatic infection to icteric hepatitis and death. The presence of antibodies to HAV confers protection against hepatitis A infection. However, the lowest titer needed to confer protection has not been determined.
","Hepatitis A vaccine should be given intramuscularly only. Do not inject it intravenously. The primary immunization consists of two doses, the first dose is at the selected date and the second dose will be at 6 months later.
Children 12 months to 15 years: The recommended dose is 0.5 ml
+
+- First dose: At the elected date
+- Second dose: 6 months after the first dose
+
+Children 16 years and above: The recommended dose is 1 ml
+
+- First dose: At the elected date
+- Second dose: 6 months after the first dose
+
","Method of administration: Hepatitis A vaccine should be injected intramuscularly in the deltoid region in adults and children and in the anterolateral part of the thigh in young children under 1 year. The vaccine should not be administered intramuscularly in the gluteal region or subcutaneously/intradermally since administration by these routes may result in less antibody response than optimal. Hepatitis A vaccine should be inspected visually for any foreign particulate matter and/or discoloration prior to administration. Before use, the vial should be well shaken to obtain a slightly milky-white suspension. The vaccine must be used as supplied.
Co-administration: Since Hepatitis A vaccine is an inactivated vaccine, its concomitant use with other inactivated vaccines is unlikely to result in interference with immune responses. When concomitant administration of other vaccines is considered necessary, the vaccines must be given with different syringes and at different injection sites. Concomitant administration of Hepatitis B, typhoid, yellow fever, cholera (injectable) or tetanus vaccine does not interfere with Hepatitis A vaccine immune response. Concomitant administration of Hepatitis A vaccine and human immune globulin may be considered when a subject is at risk of being exposed to Hepatitis A before adequate antibody titre can be reached. Hepatitis A vaccine and human immune globulin should be administered at separate injection sites.
",,"People who are allergic to any component of the vaccine. People who suffer from serious diseases, fever, and any immune disease
","Reactions at the site of injection are common but can be recovered within 72 hours without any treatment. Some of the mild and temporary adverse reactions are: pain and redness at the site of injection, fever after vaccination.
","The vaccine should be given to a pregnant woman only if clearly needed. The vaccine should be used with caution for lactating women.
","
+- Shake well before use
+- The product should be used with caution for people who or whose family has the history of convulsion or epilepsy, chronic diseases and allergic symptoms
+- Do not use the product if any crack of the container, foreign particulate matter, or out of expiry date
+- This product should be used immediately after opening
+- Adrenaline and other first aid medicines should be prepared at the vaccination place in serious allergic reaction. The people after vaccination should remain under medical supervision for 30 minutes
+- The vaccine must not be frozen
+
",,,,,"Keep out of the reach and sight of children Store and transport at 2°C to 8°C. Protect from light
",10
+1423,Imiquimod,imiquimod-1423,https://medex.com.bd/attachments/7yu79neDJFuga53vSmgZHEQj3Ne8ly/imiquimod-prescribing-information,Immunosuppressant,Basal cell carcinoma,"Imiquimod cream is indicated for the topical treatment of-
+
+- External genital and perianal warts in adults.
+- Small superficial basal cell carcinomas in adults.
+- Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and/or acceptability of cryotherapy and other topical treatment options are contraindicated or less appropriate.
+
","Immunosuppressant, Miscellaneous topical agents
","Imiquimod is a toll-like receptor-7 agonist enhancing both the innate and acquired immune response. It activates the production of numerous compounds, including IFN-α, IL-1, -6, -8, -10, -12, and TNF-α, stimulates natural killer cells and the proliferation of B-cells. It also activates Langerhans cells and promotes their migration to the regional lymph nodes. Imiquimod stimulates TH-1 cells to produce IFN-g, which in turn can activate cytotoxic T lymphocytes. These cells provide long-term immune memory, which can offer future protection against the previously encountered virus or tumor.
","External genital warts in adults: Imiquimod cream should be applied 3 times per week (example: Monday, Wednesday, and Friday; or Tuesday, Thursday, and Saturday) prior to normal sleeping hours, and should remain on the skin for 6 to 10 hours. Imiquimod cream treatment should continue until the clearance of visible genital or perianal warts or for a maximum of 16 weeks per episode of warts.
Imiquimod cream should be applied in a thin layer and rubbed on the clean wart area until the cream vanishes. Only apply to affected areas and avoid any application on internal surfaces. Imiquimod cream should be applied prior to normal sleeping hours. During the 6 to 10 hour treatment period, showering or bathing should be avoided. After this period it is essential that Imiquimod cream is removed with mild soap and water. Application of an excess of cream or prolonged contact with the skin may result in a severe application site reaction. A single use sachet is sufficient to cover a wart area of 20 cm2 (approx. 3 inches2). Sachets should not be re-used once opened. Hands should be washed carefully before and after application of cream. Uncircumcised males treating warts under the foreskin should retract the foreskin and wash the area daily.
Superficial basal cell carcinoma in adults: Apply Imiquimod cream for 6 weeks, 5 times per week (example: Monday to Friday) prior to normal sleeping hours, and leave on the skin for approximately 8 hours. Before applying Imiquimod cream, patients should wash the treatment area with mild soap and water and dry thoroughly. Sufficient cream should be applied to cover the treatment area, including one centimetre of skin surrounding the tumour. The cream should be rubbed into the treatment area until the cream vanishes. The cream should be applied prior to normal sleeping hours and remain on the skin for approximately 8 hours. During this period, showering and bathing should be avoided. After this period it is essential that Imiquimod cream is removed with mild soap and water. Sachets should not be re-used once opened. Hands should be washed carefully before and after application of cream. Response of the treated tumour to Imiquimod cream should be assessed 12 weeks after the end of treatment. If the treated tumour shows an incomplete response, a different therapy should be used. A rest period of several days may be taken if the local skin reaction to Imiquimod cream causes excessive discomfort to the patient, or if infection is observed at the treatment site. In this latter case, appropriate other measures should be taken.
Actinic keratosis in adults: Treatment should be initiated and monitored by a physician. Imiquimod cream should be applied 3 times per week (example: Monday, Wednesday and Friday) for four weeks prior to normal sleeping hours, and left on the skin for approximately 8 hours. Sufficient cream should be applied to cover the treatment area. After a 4-week treatment-free period, clearance of Actinic Keratosis should be assessed. If any lesions persist, treatment should be repeated for another four weeks. An interruption of dosing should be considered if intense local inflammatory reactions occur or if infection is observed at the treatment site. In this latter case, appropriate other measures should be taken. Each treatment period should not be extended beyond 4 weeks due to missed doses or rest periods. If the treated area does not show complete clearance at a follow-up examination about 8 weeks after the last 4-weeks course of treatment, an additional 4-weeks course of Imiquimod treatment may be considered. A different therapy is recommended if the treated lesion(s) shows insufficient response to Imiquimod. Actinic keratosis lesions that have cleared after one or two courses of treatment and subsequently recur can be re-treated with one or two further courses of Imiquimod cream following an at least 12 weeks treatment pause. Before applying Imiquimod cream, patients should wash the treatment area with mild soap and water and dry thoroughly. Sufficient cream should be applied to cover the treatment area, including one centimetre of skin surrounding the tumour. The cream should be rubbed into the treatment area until the cream vanishes. The cream should be applied prior to normal sleeping hours and remain on the skin for approximately 8 hours. During this period, showering and bathing should be avoided. After this period it is essential that Imiquimod cream is removed with mild soap and water. Sachets should not be re-used once opened. Hands should be washed carefully before and after application of cream.
Information applicable to all indications: If a dose is missed, the patient should apply the cream as soon as he/she remember and then he/she should continue with the regular schedule. However the cream should not be applied more than once a day.
",,"No interaction studies have been performed. This includes studies with immunosuppressive drugs. Interactions with systemic drugs would be limited by the minimal percutaneous absorption of Imiquimod cream. Due to its immunostimulating properties, Imiquimod cream should be used with caution in patients who are receiving immunosuppressive medication.
","Imiquimod cream is contraindicated in patients with hypersensitivity to imiquimod or cream excipients.
","Reported side effects are pustules, genital candidiasis, vaginitis, bacterial infection, fungal infection, upper respiratory tract infection, vulvitis, rhinitis, influenza, lymphadenopathy, anorexia, insomnia, depression, irritability, headache, paraesthesia, dizziness, migraine, somnolence, conjunctival irritation, eyelid oedema, tinnitus, flushing, pharyngitis, nasal congestion, pharyngo laryngeal pain, nausea, abdominal pain, diarrhoea, vomitting, rectal disorder, rectal tenesmus, dry mouth, pruritus, folliculitis, rash erythematous, eczema, rash, increased sweating, urticaria, erythema, face oedema, skin ulcer, myalgia, arthralgia, back pain, pain in extremity, dysuria, genital pain in male, penile disorder, dyspareunia, erectile dysfunction, uterovaginal prolapse, vaginal pain, vaginitis atrophic, vulval disorder, and general disorders and administration site disorders such as pruritus, pain, burning, irritation, erythema, reaction, bleeding, papules, rash, inflammation asthenia, malaise, rigors, lethargy, discomfort, fatigue, discharge, oedema, scar, ulcer, vesicle, warmth, pyrexia etc. Reports have been received of localised hypopigmentation and hyperpigmentation following Imiquimod cream use. Clinical studies investigating the use of Imiquimod for the treatment of actinic keratosis have detected a 0.4% frequency of alopecia at the treatment site or surrounding area. Reductions in haemoglobin, white blood cell count, absolute neutrophils and platelets have been observed in clinical trials.
","Use in Pregnancy B1. No human study is available. Imiquimod cream should only be used during pregnancy, if the potential benefit justifies the potential risk of fetus. No human study is available. Imiquimod cream should only be used during lactation if the potential benefit justifies the potential risk to the new-born baby.
","Hypersensitivity to the active substance or to any of the excipients.
","Use in Children: Imiquimod cream is not recommended below the age of 12 years.
Use in Elderly: Imiquimod cream is recommended in elderly patient.
Effect on ability to drive and use machineries: Imiquimod cream is unlikely to produce any effect.
","When applied topically, systemic overdosage with Imiquimod cream is unlikely due to minimal percutaneous absorption. Persistent dermal overdosing of Imiquimod cream could result in severe local skin reactions. Following accidental ingestion, nausea, emesis, headache, myalgia and fever could occur after a single dose of 200 mg Imiquimod which corresponds to the content of approximately 16 sachets. The most clinically serious adverse event reported following multiple oral doses of ≥ 200 mg was hypotension which resolved following oral or intravenous fluid administration.
",,,"Store in a cool & dry place, protected from light. Store at 4°-25°C.
",12
+597,Imipramine Hydrochloride,imipramine-hydrochloride-597,https://medex.com.bd/attachments/4mPfRrCg1tJigW9rG4aNuEaL5FzG71/imipramine-hydrochloride-tablets-prescribing-information,Tricyclic & related anti-depressant drugs,Urinary incontinence,"Imipramine Hydrochloride is indicated in-
+
+- Depressive illness
+- Nocturnal enuresis in children.
+
","Tricyclic & related anti-depressant drugs, Tricyclic Anti-depressant
","Imipramine works by inhibiting the neuronal reuptake of the neurotransmitters norepinephrine and serotonin. It binds the sodium-dependent serotonin transporter and sodium-dependent norepinephrine transporter reducing the reuptake of norepinephrine and serotonin by neurons. Depression has been linked to a lack of stimulation of the post-synaptic neuron by norepinephrine and serotonin. Slowing the reuptake of these neurotransmitters increases their concentration in the synaptic cleft, producing knock-on effects in protein kinase signaling which is thought to contribute to changes in neurotransmission and brain physiology which relieves symptoms of depression.
","Depression:
+
+- Initially up to 75 mg daily in divided doses increased gradually to 150-200 mg (up to 300 mg in hospital patients)
+- Up to 150 mg may be given as a single dose at bedtime
+- Elderly initially 10 mg daily, increased gradually to 30-50 mg daily
+- Child not recommended for depression
+
+Nocturnal enuresis:
+
+- Child 7-8 years: 25 mg
+- 8-11 years: 25-50 mg
+- Over 11 years: 50-75 mg at bedtime; max
+
+Period of treatment (including gradual withdrawal): 3 months-full physical examinations before the further course.
",,"Methylphenidate may increase the effects of imipramine. This is usually avoided by reducing the dosage of imipramine. Imipramine may increase the depressant action of alcohol. Dangerously high blood pressure has resulted from the combination of imipramine, and members of monoamine oxidase (MAO) inhibitors. Because of this, imipramine should never be taken in combination with MAO inhibitors. Patients taking any MAO inhibitors, for example phenelzine sulfate or tranylcypromine sulfate, should stop the MAO inhibitor then wait at least 14 days before starting imipramine or any other tricyclic antidepressant. The same holds true when discontinuing imipramine and starting an MAO inhibitor. The anticholinergic (drying out) effects of imipramine are additive with other anticholinergic drugs such as benztropine, biperiden, trihexyphenidyl, and antihistamines.
","Imipramine should not be given in conjunction with, or within 14 days of treatment with a MAO inhibitor. The combined therapy of this type could lead to the appearance of serious interactions such as hypertensive crises, hyperactivity, hyperpyrexia, spasticity, severe convulsions or coma and death may occur. Imipramine is contraindicated in patients with existing severe hepatic or renal damage, and those with a history of blood dyscrasias. Imipramine is contraindicated in patients who have shown hypersensitivity to the drug or hypersensitivity to tricyclic antidepressants belonging to the dibenzazepine group. Imipramine is contraindicated for use during the acute recovery phase following myocardial infarction. It should not be used in patients with convulsive disorders or glaucoma.
","The most frequent of side effects are dry mouth, constipation, urinary retention, increased heart rate, sedation, irritability, dizziness, and decreased coordination. Dry mouth, if severe to the point of causing difficulty speaking or swallowing, may be managed by dosage reduction or temporary discontinuation of the drug. Imipramine usage has been linked to both increases and decreases in blood pressure and heart rate. Heart attacks, congestive heart failure, and strokes have been reported. Confusion, disorientation, delusions, insomnia, and anxiety have also been reported as side effects in a small percentage of people taking imipramine. Problems associated with the skin (loss of sensation, numbness and tingling, rashes, spots, itching and puffiness), seizures, and ringing in the ears have also been reported. Nausea, vomiting, loss of appetite, diarrhea, and abdominal cramping are all side effects associated with imipramine usage in a small number of people.
","Pregnancy category D. Limited data suggest that imipramine is likely to be excreted in human breast milk. Known risk of damage to fetus.
","Imipramine should be used cautiously and with close physician supervision in people, especially the elderly, who have benign prostatic hypertrophy, urinary retention, and glaucoma, especially angle-closure glaucoma. The sedative effect is increased when imipramine is taken with other central nervous system depressants, such as alcoholic beverages, sleeping medications, other sedatives, or antihistamines. Imipramine may increase heart rate and stress on the heart. It may be dangerous for people with cardiovascular disease, especially those who have recently had a heart attack, to take this drug or other antidepressants in the same pharmacological class. Older people and persons with a history of heart disease may develop heart arrhythmias, heart conduction abnormalities, congestive heart failure, heart attack, abnormally rapid heart rates and strokes. Until a therapeutic dosage has been determined, people starting imipramine should be closely watched for signs of suicide. The risk of suicide is increased when imipramine is taken in overdose or combined with alcohol. Manic episodes and the emergence of symptoms of pre-existing psychotic states have been reported when imipramine therapy is started.
",,"Children have been reported to be more sensitive than adults to an acute overdosage of imipramine. An acute overdose in infants or young children must be considered serious and potentially fatal.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+255,Imipenem + Cilastatin,imipenem-cilastatin-255,https://medex.com.bd/attachments/aawMRAdToKFGaTbqrujuf41d7pUzSS/imipenem-cilastatin-prescribing-information,Other beta-lactam Antibiotics,Urinary tract infection,"The activity of Cilastatin & Imipenem against an unusually broad spectrum of pathogens makes it particularly useful in the treatment of polymicrobic mixed aerobic/anaerobic infections as well as initial therapy prior to the identification of the causative organisms. Cilastatin & Imipenem is ... Read more
The activity of Cilastatin & Imipenem against an unusually broad spectrum of pathogens makes it particularly useful in the treatment of polymicrobic mixed aerobic/anaerobic infections as well as initial therapy prior to the identification of the causative organisms. Cilastatin & Imipenem is indicated for the treatment of the following infections due to susceptible organisms:
+
+- Intra-abdominal infections
+- Lower respiratory tract infections
+- Gynaecological infections
+- Septicaemia
+- Genitourinary tract infections
+- Bone and joint infections
+- Skin and soft tissue infections
+- Endocarditis
+
","Other beta-lactam Antibiotics
","Imipenem acts as an antimicrobial through the inhibition of cell wall synthesis of various gram-positive and gram-negative bacteria. This inhibition of cell wall synthesis in gram-negative bateria is attained by binding to pencillin binding proteins (PBPs). In E. coli and selected strains of P. aeruginosa, imipenem has shown to have the highest affinity to PBP-2, PBP-1a, and PBP-1b. This preferential binding to PBP-2 and PBP-1b results in the direct conversion of the individual cell to a spheroblast, which leads to rapid cell lysis and death without filament formation.
Cilastatin is a specific and reversible renal dehydropeptidase-I inhibitor. Since the antibiotic, imipenem, is hydrolyzed by dehydropeptidase-I, which resides in the brush border of the renal tubule, cilastatin is administered with imipenem to block the metabolism and thus the inactivation of imipenem so that antibacterial levels of imipenem can be attained in the urine. The drug also prevents the metabolism of leukotriene D4 to leukotriene E4 through the inhibition of leukotriene D4 dipeptidase.
","The total daily dosage of Imipenem should be based on the type or severity of infection and given in equally divided doses based on consideration of degree of susceptibility of the pathogens, renal function and body-weight.
Imipenem & Cilastatin IV: Up to 500 mg dose should be given over 20 to 30 minutes; > 500 mg dose should be infused over 40 to 60 minutes. In patients who develop nausea during the infusion, the rate of infusion may be slowed.
Adult: Normal daily dose is 1-2 g administered in 3-4 divided doses. For the treatment of moderate infection, a 1 g b.i.d. dosage regimen may also be used. In infections due to less susceptible organisms, the daily dosage may be increased to a maximum of 4 g/day or 50 mg/kg/day, whichever is lower.
+
+- Mild infection: 250 mg 6 hourly (1 gm/day)
+- Moderate infection: 500 mg 8 hourly or 1 gm 12 hourly (1.5-2 gm/day)
+- Severe infection with fully susceptible microorganism: 500 mg 6 hourly (2gm/day)
+- Severe infection with less susceptible organisms (primarily some strains of P. aeruginosa): 1 gm 3-4 times daily (3-4 gm/day)
+
+Paediatric Dosing Schedule:
+
+- ≥ 3 months of age: the recommended dose for non-CNS infections is 15-25 mg/kg/dose administered every six hours. The maximum daily dose for treatment of infections with fully susceptible organisms is 2.0 g per day, and of infections with moderately susceptible organisms is 4.0 g/day. Higher doses (up to 90 mg/kg/day in older children) have been used in patients with cystic fibrosis.
+- ≤3 months of age: Following dosage schedule is recommended for non-CNS infections:
+- <1 week of age: 25 mg/kg every 12 hrs
+- 1-4 weeks of age: 25 mg/kg every 8 hrs
+- 4 weeks-3 months of age: 25 mg/kg every 6 hrs.
+
+Imipenem is not recommended for the therapy of meningitis. If meningitis is suspected, an appropriate antibiotic should be used. Imipenem and cilastatin for injection is not recommended in pediatric patients <30 kg with impaired renal function, as no data are available.
",,"Concurrent admin with probenecid may increase the half-life of cilastatin. Increased risk of generalised seizures when used concurrently with ganciclovir.
","Contraindicated in patients who have demonstrated hypersensitivity to this product.
","Most common side effects with imipenem are nausea and vomiting. Other side effects reported with this drug are diarrhea, rash, thrombophlebitis, thrombocytosis, neutro-penia, eosinophilia and derangements of liver and renal functions. Use of imipenem is not recommended for patient with history of anaphylactic reaction with penicillin.
","Pregnancy: Category C. There are no adequate and well controlled studies in pregnant women. Cispenam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: Imipenem has been detected in human milk. If the use of Cispenam is deemed essential, the patient should stop nursing.
","Caution when used in patients with known hypersensitivity to other β-lactams due to possibility of cross-sensitivity. CNS disorders such as epilepsy; renal, hepatic impairment; pregnancy, lactation.
","Dosage adjustment in renal impairment:
+
+- CrCl >71: No changes.
+- CrCl 41-70: Max 37.5 mg/kg/day or 3 g/day. (Range: 9.4 - 37.5 mg/kg/day) divided q6-8h.
+- CrCl 21-40: Max 25 mg/kg/day or 2 g/day. (Range: 6.25 - 25 mg/kg/day) divided q6-12h.
+- CrCl 6-20: Max 12.5 mg/kg/day (max dose 1 g/day). Range: 6.25 - 12.5 mg/kg/day) divided q12h. (Usual: 250mg q12h)
+- Dialysis Hemodialysis: 125 - 500 mg q12h. (Max 12.5 mg/kg/day). Give dose after dialysis.
+- Peritonial Dialysis: 125 - 250 mg q12h
+
","In the case of overdosage, discontinue Imipenem/Cilastatin, treat symptomatically, and institute supportive measures as required. Imipenem/Cilastatin Sodium is hemodialyzable.
",,,,11
+596,Imatinib Mesylate,imatinib-mesylate-596,https://medex.com.bd/attachments/FoHwz0HFEH6ObBTMcSOxZoB3At2RAJ/imatinib-mesylate-prescribing-information,Targeted Cancer Therapy,,"
+- Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in chronic phase.
+- Patients with Philadelphia chromosome positive chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.
... Read more
+- Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in chronic phase.
+- Patients with Philadelphia chromosome positive chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.
+- Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
+- Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy
+- Adult patients with myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
+- Adult patients with aggressive systemic mastocytosis without the D816V c-Kit mutation or with c-Kit mutational status unknown.
+- Adult patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the FIP1L1-PDGFR a fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRa fusion kinase negative or unknown.
+- Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans.
+- Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors.
+- Adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive GIST.
+
","Targeted Cancer Therapy, Tyrosine Kinase Inhibitor
","Imatinib is a small molecule protein-tyrosine kinase inhibitor that potently inhibits the activity of the Bcr-Abl tyrosine kinase (TK), as well as several receptor TKs: Kit, the receptor for stem cell factor (SCF) coded for by the c-Kit proto-oncogene, the discoidin domain receptors (DDR1 and DDR2), the colony stimulating factor receptor (CSF-1R) and the platelet-derived growth factor receptors alpha and beta (PDGFR-alpha and PDGFR beta). Imatinib can also inhibit cellular events mediated by activation of these receptor kinases.
Absorption and Distribution: Imatinib is well absorbed after oral administration with Cmax achieved within 2 4 hours post-dose. Mean absolute bioavailability is 98%. Mean Imatinib AUC increases proportionally with increasing doses ranging from 25 mg to 1,000 mg. There is no significant change in the pharmacokinetics of Imatinib on repeated dosing, and accumulation is 1.5- to 2.5- fold at a steady state when Imatinib is dosed once daily. At clinically relevant concentrations of Imatinib, binding to plasma proteins in in vitro experiments is approximately 95%, mostly to albumin and 1-acid glycoprotein.
Metabolism: CYP3A4 is the major enzyme responsible for metabolism of Imatinib. Other cytochrome P450 enzymes, such as CYP1A2, CYP2D6, CYP2C9, and CYP2C19, play a minor role in its metabolism. The main circulating active metabolite in humans is the N-demethylated piperazine derivative, formed predominantly by CYP3A4. It shows in vitro potency similar to the parent Imatinib. The plasma AUC for this metabolite is about 15% of the AUC for Imatinib. The plasma protein binding of N-demethylated metabolite CGP74588 is similar to that of the parent compound.
Excretion: Imatinib elimination is predominately in the feces, mostly as metabolites. Based on the recovery of compound(s) after an oral 14C-labeled dose of Imatinib, approximately 81% of the dose was eliminated within 7 days, in feces (68% of dose) and urine (13% of dose). Unchanged Imatinib accounted for 25% of the dose (5% urine, 20% feces), the remainder being metabolites. Following oral administration in healthy volunteers, the elimination half-lives of Imatinib and its major active metabolite, the N-demethyl derivative (CGP74588), are approximately 18 and 40 hours, respectively.
","Adults with Ph+ CML CP: 400 mg/day
Adults with Ph+ CML AP or BC: 600 mg/day
Pediatrics with Ph+ CML CP: 340 mg/m2/day
Adults with Ph+ ALL: 600 mg/day
Pediatrics with Ph+ ALL: 340 mg/m2/day
Adults with MDS/MPD: 400 mg/day
Adults with ASM: 100 mg/day or 400 mg/day
Adults with HES/CEL: 100 mg/day or 400 mg/day
Adults with DFSP: 800 mg/day
Adults with metastatic and/or unresectable GIST: 400 mg/day
Adjuvant treatment of adults with GIST: 400 mg/day
Patients with mild to moderate hepatic impairment: 400 mg/day
Patients with severe hepatic impairment: 300 mg/day
All doses of Imatinib should be taken with a meal and a large glass of water. Doses of 400 mg or 600 mg should be administered once daily, whereas a dose of 800 mg should be administered as 400 mg twice a day. Imatinib can be dissolved in water or apple juice for patients having difficulty swallowing. Daily dosing of 800 mg and above should be accomplished using the 400-mg tablet to reduce exposure to iron.
",,"Agents Inducing CYP3A Metabolism: Concomitant administration of Imatinib and strong CYP3A4 inducers may reduce total exposure of imatinib; consider alternative agents.
Agents Inhibiting CYP3A Metabolism: Concomitant administration of Imatinib and strong CYP3A4 inhibitors may result in a significant imatinib exposure increase. Grapefruit juice may also increase plasma concentrations of imatinib; avoid grapefruit juice).
Interactions with Drugs Metabolized by CYP3A4: Imatinib will increase plasma concentration of CYP3A4 metabolized drugs (e.g., triazolo-benzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, etc.). Use caution when administering Imatinib with CYP3A4 substrates that have a narrow therapeutic window. Because warfarin is metabolized by CYP2C9 and CYP3A4, use low-molecular weight or standard heparin instead of warfarin in patients who require anticoagulation.
Interactions with Drugs Metabolized by CYP2D6: Use caution when administering Imatinib with CYP2D6 substrates that have a narrow therapeutic window.
",,"The following serious adverse reactions are described elsewhere in the labeling:
+
+- Fluid Retention and Edema
+- Hematologic Toxicity
+- Congestive Heart Failure and Left Ventricular Dysfunction
+- Hepatotoxicity
+- Hemorrhage
+- Gastrointestinal Disorders
+- Hypereosinophilic Cardiac Toxicity
+- Dermatologic Toxicities
+- Hypothyroidism
+- Growth Retardation in Children and Adolescents
+- Tumor Lysis Syndrome
+- Impairments Related to Driving and Using Machinery
+- Renal Toxicity
+
","Women of childbearing potential: Women of childbearing potential must be advised to use effective contraception during treatment and for at least 15 days after stopping treatment with Imatinib.
Pregnancy: There are limited data on the use of imatinib in pregnant women. There have been post-marketing reports of spontaneous abortions and infant congenital anomalies from women who have taken Imatinib. Studies in animals have however shown reproductive toxicity and the potential risk for the foetus is unknown. Imatinib should not be used during pregnancy unless clearly necessary. If it is used during pregnancy, the patient must be informed of the potential risk to the foetus.
Breast-feeding: There is limited information on imatinib distribution on human milk. Studies in two breast feeding women revealed that both imatinib and its active metabolite can be distributed into human milk. The milk plasma ratio studied in a single patient was determined to be 0.5 for imatinib and 0.9 for the metabolite, suggesting greater distribution of the metabolite into the milk. Considering the combined concentration of imatinib and the metabolite and the maximum daily milk intake by infants, the total exposure would be expected to be low (-10% of a therapeutic dose). However, since the effects of low-dose exposure of the infant to imatinib are unknown, women should not breast-feed during treatment and for at least 15 days after stopping treatment with Imatinib.
Fertility: In non-clinical studies, the fertility of male and female rats was not affected, although effects on reproductive parameters were observed. Studies on patients receiving Imatinib and its effect on fertility and gametogenesis have not been performed. Patients concerned about their fertility on Imatinib treatment should consult with their physician.
","
+- Edema and severe fluid retention have occurred. Weigh patients regularly and manage unexpected rapid weight gain by drug interruption and diuretics.
+- Cytopenias, particularly anemia, neutropenia, and thrombocytopenia, have occurred. Manage with dose reduction, dose interruption, or discontinuation of treatment. Perform complete blood counts weekly for the first month, biweekly for the second month, and periodically thereafter.
+- Severe congestive heart failure and left ventricular dysfunction have been reported, particularly in patients with comorbidities and risk factors. Monitor and treat patients with cardiac disease or risk factors for cardiac failure.
+- Severe hepatotoxicity, including fatalities may occur. Assess liver function before initiation of treatment and monthly thereafter or as clinically indicated. Monitor liver function when combined with chemotherapy known to be associated with liver dysfunction.
+- Grade 3/4 hemorrhage has been reported in clinical studies in patients with newly diagnosed CML and with GIST. Gl tumor sites may be the source of Gl bleeds in GIST. Gastrointestinal (Gl) perforations, some fatal, have been reported.
+- Cardiogenic shock/left ventricular dysfunction has been associated with the initiation of Imatinib in patients with conditions associated with high eosinophil levels (e.g., HES, MDS/MPD, and ASM).
+- Bullous dermatologic reactions (e.g., erythema multiforme and Stevens-Johnson syndrome) have been reported with the use of Imatinib.
+- Hypothyroidism has been reported in thyroidectomy ZyvaxatX patients undergoing levothyroxine replacement. Closely monitor TSH levels in such patients.
+- Fetal harm can occur when administered to a pregnant woman. Apprise women of the potential harm to the fetus, and to avoid pregnancy when taking Imatinib.
+- Growth retardation occurring in children and pre-adolescents receiving Imatinib has been reported. Close monitoring of growth in children under Imatinib treatment is recommended.
+- Tumor Lysis Syndrome. Close monitoring is recommended.
+- Reports of motor vehicle accidents have been received in patients receiving Imatinib. Caution patients about driving a car or operating machinery.
+- Renal Toxicity. A decline in renal function may occur in patients receiving Imatinib. Evaluate renal function at baseline and during therapy, with attention to risk factors for renal dysfunction.
+
",,"Experience with doses higher than the recommended therapeutic dose is limited. In the event of overdose the patient should be observed and an appropriate symptomatic treatment given. Generally, the reported outcome in these cases was ""improved"" or ""recovered"". Events that have been reported at different dose ranges are as follows:
Adult Population:
+
+- 1200 to 1600 mg (duration varying between 1 to 10 days): Nausea, vomiting, diarrhoea, rash, erythema, oedema, swelling, fatigue, muscle spasms, thrombocytopenia, pancytopenia, abdominal pain, headache, decreased appetite.
+- 1800 to 3200 mg (as high as 3200 mg daily for 6 days): Weakness, myalgia, increased creatine phosphokinase,
+- increased bilirubin, gastrointestinal pain.
+- 6400 mg (single dose): One case reported in the literature of one patient who experienced nausea, vomiting, abdominal pain, pyrexia, facial swelling, decreased neutrophil count, and increased transaminases.
+- 8 to 10 g (single dose): Vomiting and gastrointestinal pain have been reported.
+
+
Paediatric population: One 3-year-old male exposed to a single dose of 400 mg experienced vomiting, diarrhoea and anorexia and another 3-year-old male exposed to a single dose of 980 mg experienced decreased white blood cell count and diarrhoea. In the event of overdose, the patient should be observed and appropriate supportive treatment given.
",,,"Store below 30°C, in a cool and dry place. Keep away from light. Keep out of the reach of children.
",10
+599,Iloperidone,iloperidone-599,https://medex.com.bd/attachments/pY07oFskCwpVANULhY5bp0gFQFBep3/iloperidone-prescribing-information,Piperidinyl-benzisoxazole derivative,Schizophrenia,"Iloperidone is indicated for the treatment of schizophrenia in adults.
When deciding among the alternative treatments available for this condition, the prescriber should consider the finding that iloperidone is associated with prolongation of the QTc interval. Prolongation of the QTc interval ... Read more
Iloperidone is indicated for the treatment of schizophrenia in adults.
When deciding among the alternative treatments available for this condition, the prescriber should consider the finding that iloperidone is associated with prolongation of the QTc interval. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointestype arrhythmia, a potentially fatal polymorphic ventricular tachycardia which can result in sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether iloperidone will cause torsade de pointes or increase the rate of sudden death is not yet known.
Patients must be titrated to an effective dose of iloperidone. Thus, control of symptoms may be delayed during the first 1 to 2 weeks of treatment compared to some other antipsychotic drugs that do not require a similar titration. Prescribers should be mindful of this delay when selecting an antipsychotic drug for the treatment of schizophrenia
","Piperidinyl-benzisoxazole derivative
","Iloperidone shows high affinity and maximal receptor occupancy for dopamine D2 receptors in the caudate nucleus and putamen of the brains of schizophrenic patients. The improvement in cognition is attributed to iloperidone's high affinity for α adrenergic receptors. Iloperidone also binds with high affinity to serotonin 5-HT2a and dopamine 3 receptors. Iloperidone binds with moderate affinity to dopamine D4, serotonin 5-HT6 and 5-HT7, and norepinephrine NEα1 receptors. Furthermore, iloperidone binds with weak affinity to serotonin 5-HT1A, dopamine D1, and histamine H1 receptors.
","Initial dose: 1 mg orally twice a day
Titration: Increase in increments of not more than 2 mg twice daily as tolerated.
Target dose: 6 to 12 mg twice a day
Maximum dose: 24 mg/day
This drug must be titrated slowly to avoid orthostatic hypotension; because of the need to titrate slowly, control of symptoms may be delayed during the first 1 to 2 weeks of treatment.
",,"There are no known drug interactions and none well documented.
","Hypersensitivity.
","Dizziness (20%), Dry mouth (15%), Nausea (10%), Somnolence (10%), Tachycardia, Diarrhea, Ejaculation failure, Myalgia, Nasal congestion, Orthostatic hypotension, Palpitations, Urinary incontinence, Weight gain
","Pregnancy Category-C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Lactation: Not known if excreted in breast milk, do not nurse.
","This drug is not approved for the treatment of patients with dementia-related psychosis. Prolongs QT interval; caution with other drugs/conditions that increase QTc. Risk of neuroleptic malignant syndrome and extrapyramidal symptoms. May cause anticholinergic side effects (eg., confusion, agitation). Blood dyscrasias (leukopenia, neutropenia, agranulocytosis) may occur. Orthostatic hypotension may occur.
","Renal Dose Adjustments: No adjustment recommended.
Liver Dose Adjustments-
+
+- Mild hepatic impairment: No adjustment recommended.
+- Moderate hepatic impairment: Use with caution.
+- Severe hepatic impairment: Not recommended.
+
",,,,,10
+595,Ifosfamide,ifosfamide-595,https://medex.com.bd/attachments/a1zMQTTF9ds5NmBXGfFfo6tTSMCN2Q/ifosfamide-ifosfamide-prescribing-information,Cytotoxic Chemotherapy,Testicular cancer,"Ifosfamide is indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. It should be used in combination with Mesna for prophylaxis of hemorrhagic cystitis.
","Cytotoxic Chemotherapy
","Ifosfamide is converted to its active metabolites via hepatic microsomal enzymes. These active metabolites act as alkylating agents, disrupting DNA and protein synthesis of the target cells. It is routinely given with mesna to reduce urothelial toxicity.
","Lymphoma, Sarcoma, Solid tumours: Different licensed dosage regimens are available.
+
+- Regimen 1: 8-12 gm/m2 divided over 3-5 days, repeat course every 2-4 wk.
+- Regimen 2: 6 gm/m2 divided over 5 days, repeat course every 3 wk.
+- Regimen 3: 5-6 gm/m2 (max: 10 gm), give as a single 24-hr infusion, repeat course every 3-4 wkly.
+
+
Germ cell testicular carcinoma: 1.2 gm/m
2/day for 5 days via slow infusion over at least 30 minutes, repeat treatment every 3 wk or after recovery from haematological toxicity. To be given with mesna and adequate hydration of at least 2 L of oral or IV fluid per day.
",,"Causes enhanced toxicity with allopurinol, cisplatin. Ifosfamide enhances the anticoagulant effect of warfarin. CYP2A6 inducers (e.g. amobarbital, pentobarbital, phenobarbital, rifampin and secobarbital) may reduce serum levels of ifosfamide while the inhibitors (e.g. isoniazid, methoxsalen and miconazole) may increase its serum levels. CYP3A4 inducers (e.g. aminoglutethimide, carbamazepine, nafcillin, nevirapine, phenobarbital, phenytoin, and rifamycins) may reduce serum levels of ifosfamide while the inhibitors (e.g. azole antifungals, clarithromycin, diclofenac, doxycycline, erythromycin, imatinib, isoniazid) may increase its serum levels.
","Hypersensitivity; severe bone-marrow depression. Pregnancy, lactation.
","Confusion, alopoecia, nausea, vomiting, phloebitis, somnolence, depression, hallucinations. Wound healing may be impaired during ifosfamide use.
Potentially Fatal: Severe myelosuppression, haemorrhagic cystitis, nephrotoxicity, cardiotoxicity, coma.
","Category D: There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Hepatic or renal dysfunction, compromised bone marrow reserve. Use with mesna and ensure high oral/IV fluid intake to reduce urotoxic effects.
","Renal Impairment: CrCl <10: Administer 75% of dose.
",,,"Add 20 ml of sterile water for inj or sterile bacteriostatic water for inj containing benzyl alcohol or parabens for each 1 g of the drug to produce solutions of 50 mg/ml.
","Store at 20-25° C.
",12
+594,Idoxuridine,idoxuridine-594,,Ophthalmic Anti-viral Products,Herpes simplex keratitis,"Idoxuridine Eye drops is used for Skin infection, Eyes infection, Infection of reproduction organs, Herpes simplex infections of skin, External reproductive organs infection, External eyes area infection and other conditions. Idoxuridine Eye drops may also be used for purposes not listed in this medication guide.
","Ophthalmic Anti-viral Products
","Herpes simplex virus utilizes thymidine in the synthesis of deoxyribonucleic acid (DNA), a metabolite necessary for reproduction. Idoxuridine is identical in chemical structure to thymidine except that the 5-methyl group is replaced by iodine. When idoxuridine is substituted for thymidine in DNA, the cell is unable to utilize the DNA and reproduction ceases.
","Herpes simplex keratitis: As 0.1% solution: Instill 1 drop in the affected eye(s) every hour. Taper to every 2 hr or 4 times daily. Continue treatment for at least 7 days.
",,"Corticosteroids may accelerate spread of viral infection.
","Contraindicated in hypersensitivity to any ingredient of this preparation.
","Common side effects are eye irritation or pain, redness, itching, swelling of the eye, increased sensitivity to light and glare
","Idoxuridine should be administered with caution in pregnancy or in women of childbearing potential. Idoxuridine has been reported to cross the placental barrier and to produce fetal malformations in rabbits when administered topically to the eyes of pregnant females in doses similar to those used clinically.
","For topical use only. Do not exceed the frequency or duration of recommended dosage. The incidence of some adverse reactions increases with prolonged use. Idoxuridine is not effective in corneal inflammations following herpes simplex keratitis in which the virus is not present. Some strains of herpes simplex appear resistant to the action of Idoxuridine.
",,,,,"Store medicines at room temperature, away from heat and direct light. Do not freeze medicines unless required by package insert. Keep medicines away from children.
",10
+626,Irbesartan,irbesartan-626,https://medex.com.bd/attachments/nKUeVzoqPW0nzBaKM2HxDD56ndSSro/irbesartan-prescribing-information,Angiotensin-ll receptor blocker,Hypertension,"Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive drug regimen.
","Angiotensin-ll receptor blocker
","Irbesartan is an angiotensin II receptor antagonist. It blocks the vasoconstricting and aldosterone-secreting effects of angiotensin II by binding to AT1 receptors.
","Adult: The usual recommended initial and maintenance dose is Irbesartan 150 mg once daily, with or without food. Irbesartan at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg. However, initiation of therapy with Irbesartan 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years. In patients insufficiently controlled with Irbesartan 150 mg once daily, the dose of Irbesartan can be increased to Irbesartan 300 mg, or other anti-hypertensive agents can be added. In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Irbesartan. In hypertensive type 2 diabetic patients, therapy should be initiated at Irbesartan 150 mg once daily and titrated up to Irbesartan 300 mg once daily as the preferred maintenance dose for treatment of renal disease. The demonstration of renal benefit of Irbesartan in hypertensive type 2 diabetic patients is based on studies where Irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure.
Elderly: although consideration should be given to initiating therapy with Irbesartan 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly
Paediatric: Irbesartan is not recommended for use in children and adolescents due to insufficient data on safety and efficacy.
",,"Diuretics and other antihypertensive agents: prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Irbesartan.
Potassium supplements and potassium-sparing diuretics: based on experience with the use of other drugs that affect the renin-angiotensin system, concomitant use of potassiumsparing diuretics, potassium supplements, salt substitutes containing potassium or other drugs that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended.
Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. Similar effects have been very rarely reported with irbesartan so far. Therefore, this combination is not recommended. If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Non-steroidal anti-inflammatory drugs: When angiotensin II antagonists are administered simultaneously with non-steroidal anti- inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid > 3 g/day and non-selective NSAIDs), attenuation of the antihypertensive effect may occur. Additional information on irbesartan interactions: In clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide. Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation. No significant pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was coadministered with warfarin, a drug metabolised by CYP2C9. The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated. The pharmacokinetic of digoxin was not altered by coadministration of irbesartan.
","Concomitant use with aliskiren in patients with diabetes and renal impairment (GFR <60 ml/min). Pregnancy.
","Diarrhoea, fatigue, dyspepsia or heartburn, dizziness, orthostatic hypotension, nausea, vomiting, musculoskeletal pain, thrombocytopaenia, hyperkalaemia, elevated serum creatinine.
","Pregnancy: Irbesartan is contraindicated in the second and third trimesters of pregnancy. In the second and third trimesters, substances that act directly on the renin-angiotensin-system can cause foetal or neonatal renal failure, foetal skull hypoplasia and even foetal death. As precautionary measure, irbesartan should preferably not be used during first trimester of pregnancy. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy. If pregnancy is diagnosed, irbesartan should be discontinued as soon as possible, skull and renal function should be checked with echography if, inadvertently, the treatment was taken for a long period.
Lactation: Irbesartan is contraindicated during lactation. It is not known whether irbesartan is excreted in human milk. Irbesartan is excreted in the milk of lactating rats. Precautions: Intravascular volume depletion: symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of Irbesartan.
","Patients with unilateral or bilateral renal artery stenosis, depletion of intravascular volume, aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Renal impairment. Lactation.
","Renal impairment: no dosage adjustment is necessary in patients with impaired renal function. A lower starting dose of Irbesartan 75 mg should be considered for patients undergoing haemodialysis. Intravascular volume depletion: volume and/or sodium depletion should be corrected prior to administration of Irbesartan.
Hepatic impairment: no dosage adjustment is necessary in patients with mild to moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment.
Hypertensive patients with type 2 diabetes and renal disease: the effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease. In particular, they appeared less favourable in women and non-white subjects.
Hyperkalaemia: as with other drugs that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Irbesartan, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure. Close monitoring of serum potassium in patients at risk is recommended.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti-hypertensive drugs acting through inhibition of the renin-angiotensin system. Therefore, the use of Irbesartan is not recommended.
General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensinaldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure. As with any anti-hypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
","Experience in adults exposed to doses of up to 900 mg/day for 8 weeks revealed no toxicity. The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose. No specific information is available on the treatment of overdosage with Irbesartan. The patient should be closely monitored, and the treatment should be symptomatic and supportive. Suggested measures include induction of emesis and/or gastric lavage. Activated charcoal may be useful in the treatment of overdosage. Irbesartan is not removed by haemodialysis.
",,,"Store in a cool and dry place, protected from light.
",12
+1309,Ipratropium Bromide (Nebuliser Solution),ipratropium-bromide-nebuliser-solution-1309,,Anticholinergic bronchodilators,Severe bronchospasm,"Ipratropium Nebuliser Solution is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
","Anticholinergic bronchodilators
","Ipratropium Bromide is a quaternary ammonium compound with anticholinergic properties. It appears to inhibit vagal reflexes by antagonising the action of acetylcholine (the transmitter agent released from the vagus nerve). Anticholinergics prevent the increase in intracellular concentration of cyclic guanosine monophosphate (cyclic GMP) caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle.
","Children over 3 years: The usual dose is 0.4-2.0 ml Ipratropium Bromide Solution (100-500 micrograms) up to three times daily.
Adults (including elderly and adolescents) over 12 years of age: The usual dose is 0.4-2.0 ml Ipratropium Bromide Solution (100-500 micrograms) up to four times daily.
",,,"Ipratropium Bromide solution should not be taken by patients with known hypersensitivity to atropine or its derivatives or to any other component of the product.
","Allergic-type reactions such as skin rash, angio-oedema of the tongue, lips and face, urticaria (including giant urticaria), laryngospasm and anaphylactic reactions have been reported, with positive rechallenge in some cases.
","The safety of Ipratropium Bromide during human pregnancy has not been established. The benefits of using Ipratropium Bromide during a confirmed or suspected pregnancy must be weighed against possible hazards to the unborn child. It is not known whether Ipratropium Bromide is excreted into breast milk.
","Ipratropium Bromide should be used with caution in patients predisposed to narrow-angle glaucoma, or with prostatic hyperplasia or bladder-neck obstruction.
",,,,,"Should be stored in cool and dry place
",9
+624,Ipratropium Bromide (Inhaler),ipratropium-bromide-inhaler-624,https://medex.com.bd/attachments/t4mDbOP0DLw55cxxXCRmsxrm61gaUb/ipratropium-bromide-inhaler-prescribing-information,Anticholinergic bronchodilators,Emphysema,"Ipratropium inhaler is indicated for-
+
+- As bronchodilator in treatment of chronic reversible airway obstruction as in asthma and Chronic Obstructive Pulmonary Disease (COPD) including chronic bronchitis and emphysema.
+- Treatment of acute reversible airways obstruction.
+
","Anticholinergic bronchodilators
","Ipratropium bromide causes bronchodilation by blocking the action of acetylcholine at parasympathetic site in bronchial smooth muscle. It also inhibits serous and seromucous gland secretions by nasal application.
","Adults: The usual dose is 1-2 puffs (20 µg/puff) three or four times daily. Single-dose up to 80 µg (4 puffs) may be required to obtain maximum benefit during early treatment. Patients may take additional inhalations as required: however, the total number of inhalations should not exceed 12 puffs in 24 hours.
Children:
+
+- 6-12 years: Usually 1-2 puffs two to three times daily.
+- Bellow 6 years: The usual dose is 1 puff (20 µg) three times daily.
+
+In order to ensure that the inhaler is used correctly, the administration should be supervised by an adult.
No specific information on the use of the product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.
","Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.
Following simple steps can help to use Inhaler effectively (According to ""
National Asthma Guidelines for Medical Practitioners"" published by Asthma Association):
+
+- Take off the cap.
+- Shake the inhaler (at least six times) vigorously before each use.
+- If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
+- Breathe out as full as comfortably possible & hold the inhaler upright.
+- Place the actuator into mouth between the teeth and close lips around the mouthpiece.
+- While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
+- Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
+- If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
+- After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
+- Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.
+
+
Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.
","Ipratropium bromide has been used concomitantly with other drugs, including sympathomimetic bronchodilators, methylxanthines, steroids and cromolyn sodium, commonly used in treatment of COPD, without any adverse drug reactions, there are no studies fully evaluating the interaction effects of lpratropium bromide and these drugs in respect to effectiveness.
","Known hypersensitivity to ipratropium bromide, Atropine or its derivative. Also contraindicated in patients with a history of hypersensitivity to soya lecithin or related food products such as soyabean, lecithin and peanut.
","Idiosyncratic reactions to lpratropium bromide are rare. Severe adverse effects due to inhibition of muscarinic receptors and ganglion blockade are theoretically possible but unlikely with the metered-dose aerosol. Regular use of ipratropium can lead to a dry mouth through inhibition of salivary flow.
Other most common adverse reactions reported are - dryness of the oropharynx (5%); cough, exacerbation of symptoms, & imitation from aerosol (3%); headache (2%); nausea, dizziness, blurred vision/difficulty in accommodation & drying of secretions (1%).
Less frequently reported adverse reactions include tachycardia, nervousness, paresthesias, drowsiness, co-ordination difficulty, itching, flushing, alopecia, constipation, tremor & mucosal ulceration. Case of precipitation or worsening of narrow-angle glaucoma, acute eye pain & hypotension also have been reported. Allergic-type reactions such as skin rash, angio-oedema of tongue, lips & face, urticaria (including giant urticaria), laryngospasm and anaphylactic reaction have been also reported; with positive rechallenge in some cases.
Ipratropium bromide dose not produce adverse effects on mucociliary clearance, in contrast to atropine and other muscarinic antagonists. There is no evidence that in the therapeutic does range ipratropium bromide has any adverse effect on bronchial secretion.
","The safety of Ipratropium Bromide during human pregnancy has not been established. The benefits of using Ipratropium Bromide during a confirmed or suspected pregnancy must be weighed against possible hazards to the unborn child. It is not known whether Ipratropium Bromide is excreted into breast milk.
","Patients should be advised that temporary blurring of vision, precipitation or worsening of narrow angle glaucoma or eye pain may result if the aerosol is sprayed into the eyes. If recommended dosage does not provide relief or symptoms become worse, patients should seek immediate medical attention. While taking ipratropium bromide inhalation aerosol, other inhaled drugs should not be used unless prescribed.
lpratropium bromide inhalation aerosol is not indicated for the initial treatment of acute episodes of bronchospasm where rapid response is required. Drugs with faster onset may be preferable as initial therapy in this situation. Immediate hypersensitivity reactions may occur after administration of ipratropium bromide, as demonstrated by rare cases of urticaria, angio-oedema, rash, bronchospasm and oropharyngeal oedema.
",,"Acute overdosage by inhalation is unlikely since ipratropium bromide is not well absorbed systematically after administration as aerosol. Inhaled dosage of 5 mg of ipratropium bromide produce an increase in heart rate and palpitation. Single doses of ipratropium bromide 30 mg by mouth caused anticholinergic side effects but which were not considered severe enough to require specific reversal.
",,,"The inhaler should be stored in a dry and cool place. Protected from direct sunlight and heat. Keep away from eyes. Keep out of reach of children. The canister should not be broken, punctured or burnt, even when apparently empty.
",12
+623,Iopamidol,iopamidol-623,https://medex.com.bd/attachments/1EmO1XAoaWX3AMQ4fPdqWMxcCW1dVs/iopamidol-prescribing-information,Contrast medium for diagnostic procedures,Radiographic contrast medium for diagnostic procedures,"Neuroradiology: Lumber myelography, thoraco-cervical myelography
Angiography: Cerebral angiography, selective coronary angiography, left ventriculography, aortography, angiocadiography, selective visceral arteriography, peripheral arteriography ... Read more
Neuroradiology: Lumber myelography, thoraco-cervical myelography
Angiography: Cerebral angiography, selective coronary angiography, left ventriculography, aortography, angiocadiography, selective visceral arteriography, peripheral arteriography, digital subtraction angiography, venography, urography
Other diagnostic procedures: Contrast enhancement in CT scanning, arthrography, fistulography.
","Contrast medium for diagnostic procedures
","Iopamidol, an organic Iodine compound and used as a non-ionic water soluble radiographic contrast medium. Iopamidol blocks X-rays as they pass through the body, thereby allowing body structures not containing Iodine to be visualized. The degree of opacity produced by Iopamidol is directly proportional to the total amount of the iodinated contrast agent in the path of the X-rays. The visualization of body structures is dependent upon the distribution and elimination of Iopamidol.
","Adult dosage:
+
+- Neurology: Lumber myelography: Iopamidol 370, 6-13 ml,
+- Thoraco-cervical myelography: Iopamidol 370, 6-13 ml.
+- Urography: Iopamidol 370, 40-80 ml IV up to 1.5 ml/kg in severe renal disease.
+
+Children:
+
+- Usual Dose: 1-2.5 ml/kg
+- Other Diagnostic Procedure: Contrast enhancement in CT scanning: Iopamidol 370, 0.5-2.0 ml/kg
+
+
Angiography: Cerebral angiography: Iopamidol 370, 6-13 ml
Selective coronary arteriography: Iopamidol 370, 4-8 ml/artery
Peripheral arteriography: Iopamidol 370, 20-50 ml
Venography: Iopamidol 370, 24-60 ml
Angiocardiography: Iopamidol 370, 30-80 ml
Left ventriculography: Iopamidol 370, 30-80 ml
Percutaneous transfemoral or renal arteriography: Iopamidol 370, 30 ml
Selective renal arteriography: Iopamidol 370, 5-10 ml
Hepatic angiography: Iopamidol 370, 70 ml
Coeliac angiography: Iopamidol 370, 40-70 ml
Superior mesenteric angiography: Iopamidol 370, 25-50 ml
Inferior mesenteric angiography: Iopamidol 370, 5-30 ml
Digital subtraction angiography: 30-50 ml (10-20 ml/sec) of Iopamidol 370, IV 25 ml (left ventricle), 2-5 ml (coronary arteries) ,15 ml/sec. of Iopamidol 370 i.a for cardiac imaging
","NEURORADIOLOGY-
Lumber myelography: A slow sub-arachnoid injection is made through a fine lumber puncture needle into one of the lower interspinous spaces (L3-L4 or L4-L5). Optimum contrast appears immediately after injections and films should be obtained promptly.
Thoraco-cervical myelography: Following a slow sub-arachnoid injection the patient should be turned on his/her side and tilted 10o-20o head down under fluoroscopic control. In this manner it is possible to control movement of the contrast medium column into the dorsal region.
If the cervical region is to be examined, the contrast medium should be run into the cervical region first, before the examination of the dorsal areas where it is progressively diluted. Iopamidol 300/370 may also be injected sub-occipitally or by lateral puncture technique .Care should be taken to ensure that the contrast medium does not move intracranially. It is generally recommended that in intrathecal use the patient should remain with a raised bed head and be kept well hydrated; following hydration it is preferable that the patient be allowed to be ambulatory .
ANGIOGRAPHY-
Cerebral angiography: Any current technique is suitable for radiological visualization of the cerebral vasculature with Iopamidol 370/300 injection. Carotid and vertebral angiography, performed by catheterization or percutaneous injection techniques, require rapid injection which, if necessary, may be repeated.
Peripheral arteriography and venography: Percutaneous injection into the appropriate blood vessel is used for visualization of peripheral arteries and veins.
Angiocardiography, left ventriculography, selective coronary arteriography: Iopamidol 370/300 injection may be administered by rapid injection through a catheter into a suitable peripheral artery or vein. It can also be introduced under pressure through a cardiac catheter in to any of the heart chambers, or injected into large vessel for immediate visualization. The contrast medium may also be administered during selective catheterization of the coronary arteries.
Aortography: The contrast medium may be introduced directly or by intra-arterial injection for visualization of the aorta and its main branches.
Selective visceral angiography: Visualization can be achieved by selective catheterization and injection into the hepatic, coeliac or mesenteric arteries.
Digital subtraction angiography: For cardiac imaging the contrast medium may be administered intra-arterially by selective catheterization to provide substrated images. Iopamidol 370/300 injected intravenously either centrally or peripherally is also recommended for use this modality.
UROGRAPHY-
The contrast medium injected intravenously and rapidly eliminated through the kidneys. In patients with severe renal failure, high dose urography should be used.
OTHER DIAGNOSTIC PROCEDURES-
Arthrography: Visualization of joint cavities and articular surfaces can be achieved either single or double contrast examination.
Contrast enhancement in CT scanning: Contrast enhancement for brain scans can be achieved between one and three minutes after i.v. injection. Iopamidol 370/300 are also be used for total body scanning examinations after i.v.administration as a bolus, as a drip infusion or by combination of the two methods.
","Iopamidol may interfere with thyroid function. Biguanide compete for excretion in the kidneys with contrast media and this could lead to reduction in kidney function. Patient taking Metformin or other Biguanides should therefore not take any doses of Metformin for 48 hours before or 48 hours after the X-ray examination.
","There are no definite or absolute contraindications to the use of Amidol, with the possible exception of waldenstrom's macroglobulinemia, multiple myeloma and severe liver and kidney disease.
","Common side effects are arrhythmias, arterial spasm, flushing, vasodilatation, angina, cardiopulmonary arrest; dizziness, confusion, paraesthesia, visual disturbances, seizure, paralysis, coma, temporary amnesia; inj site pain, pallor, periorbital and facial oedema; coughing, sneezing, rhinitis, asthma, apnoea, laryngeal oedema, chest tightness; watery itchy eyes, lachrymation, conjunctivitis; muscle spasm, involuntary leg movement; tremors, malaise; severe retching and choking, abdominal pain; urogenital pain, haematuria.
","Iopamidol injection should be administered in pregnancy only if the procedure is considered essential by the physician.
","May inhibit blood coagulation. Multiple myeloma or other paraproteinaemia. Sickle-cell disease. Known or suspected phaeochromocytoma (monitor closely). Hyperthyroidism. Ensure adequate hydration. History of a previous sensitivity to a contrast medium, sensitivity to iodine, bronchial asthma, hay fever and food allergy. Monitor patients with CHF. Avoid angiography in patients with homocystinuria. Severe arterial or venous disease. Severe renal impairment, combined renal and hepatic disease or anuria, especially when large doses are used. Pregnancy and lactation.
",,"Treatments of an overdose is directed toward the support of all vital functions and prompt institution of symptomatic therapy.
",,,"Store at 20-25° C
",12
+621,Iohexol,iohexol-621,https://medex.com.bd/attachments/0aoZvWybRYTbiwCW4jaCPxmkkRmWLz/iohexol-research-brand-prescribing-information,Contrast medium for diagnostic procedures,Radiographic contrast medium for diagnostic procedures,"Iohexol is an X-ray contrast medium for use in adults and children for cardioangiography, arteriography, urography, phlebography and CT-enhancement. Lumbar, thoracic, cervical myelography and computed tomography of the basal cisterns, following subarachnoid injection. It is also indicated for arthrography ... Read more
Iohexol is an X-ray contrast medium for use in adults and children for cardioangiography, arteriography, urography, phlebography and CT-enhancement. Lumbar, thoracic, cervical myelography and computed tomography of the basal cisterns, following subarachnoid injection. It is also indicated for arthrography, endoscopic retrograde pancreatography (ERP), endoscopic retrograde cholangiopancreatography (ERCP), herniography, hysterosalpingography, sialography and studies of the gastrointestinal tract when the use of barium sulphate is unsatisfactory, undesirable or contraindicated.
The dosage varies depending on the type of examination, age, weight, cardiac output and general condition of the patient and the technique used. Usually the same iodine concentration and volume is used as with other iodinated X-ray contrast media in current use. Adequate hydration should be assured before and after administration as for other contrast media.
+
","Contrast medium for diagnostic procedures
","Iohexol provides opacification of blood vessels and permits radiographic visualisation until sufficient haemodilution occurs or sufficient contrast medium has left the site of injection. Being a non-ionic compound, Iohexol yields solutions of lower osmolality than the conventional ionic contrast media. Intravenous or intra-arterial injection of Iohexol causes less pain and sensation of heat than conventional ionic media with similar iodine content. Iohexol solutions cause less cardiac and vascular disturbances on intravascular injection. The transit time of Iohexol through the coronary vascular system is slightly increased compared with conventional ionic contrast media, probably due to the increased viscosity of Iohexol at comparable iodine concentrations. The period of maximal opacification of the renal vessels may begin as early as 30 seconds after IV injection. Urograms become apparent in about 1 to 3 minutes with optimal contrast occurring between 5 to 15 minutes. In nephropathic conditions, particularly when excretory capacity has been altered, the rate of excretion may vary unpredictably, and opacification may be delayed after injection. Severe renal impairment may result in a lack of diagnostic opacification of the collecting system. The initial concentration and volume of the medium, in conjunction with appropriate patient manipulation and the volume of CSF into which the medium is placed, will determine the extent of diagnostic contrast that can be achieved. Following subarachnoid injection, Iohexol will continue to provide good diagnostic contrast by conventional radiography for at least 30 minutes. Slow diffusion of Iohexol takes place throughout the CSF as well as transfer into the circulation. At approximately 1 hour, contrast of diagnostic quality will not usually be available for conventional myelography. However, sufficient contrast for CT myelography will be available for several hours. If CT myelography is to follow, it should be deferred for several hours to allow the degree of contrast to decrease. Following lumbar subarachnoid placement, irrespective of the position in which the patient is later maintained, slow upward diffusion of Iohexol takes place throughout the CSF. CSF contrast enhancement for CT scanning may be expected in the thoracic region in about 1 hour, in the cervical region in about 2 hours and in the basal cisterns in 3 to 4 hours after administration into the lumbar subarachnoid space.
","Injection As iohexol soln containing 6-350 mg iodine/mL: Dose and strength used depends on the procedure and route of administration.
+
Injection-
+Angiocardiography:
+
+- Adult: Ventriculography: 350 mg iodine/ml: 30-60 ml, usual: 40 ml, may be repeated as necessary. If with selective coronary arteriography: max 250 ml. Selective coronary arteriography: 350 mg iodine/ml: 3-14 ml per inj, usual: 5 ml. Aortic root and arch study when used alone: 350 mg iodine/ml: 20-75 ml, usual 50 ml. Multiple procedures: 350 mg iodine/ml: max 250 ml.
+- Child: Ventriculography: 350 mg iodine/ml: 1-1.5 ml/kg, usual: 1.25 ml/kg; 300 mg iodine/ml: 1.5-2 ml/kg, usual 1.75 ml/kg. Max: 5 ml/kg; 350 mg iodine/ml: 250 ml; 300 mg iodine/ml: 291 ml. Pulmonary angiography: 350 mg iodine/ml: 1 ml/kg. Multiple procedures: Max: 5 ml/kg; 350 mg iodine/ml: 250 ml; 300 mg iodine/ml: 291 ml.
+
+Aortography and selective visceral arteriography
+
+- Adult: Use 300 or 350 mg iodine/ml solution, single inj. Aorta: 50-80 ml; major branches: 30-60 ml; renal arteries: 5-15 ml. Repeat as necessary. Max: 300 mg iodine/ml: 291 ml; 350 mg iodine/ml: 250 ml.
+- Child: Use 350 mg iodine/ml solution: 1 ml/kg, single dose. Max: 5 ml/kg up to 250 ml.
+
+Voiding cystourethrography:
+
+- Adult: Use diluted solutions using sterile water for inj to concentrations of 50-100 mg iodine/ml. Usual volume: 50 mg iodine/ml solution: 50-600 ml; 100 mg iodine/ml: 50-300 ml.
+- Child: Children: Use diluted solutions using sterile water for inj to concentrations of 50-100 mg iodine/ml: 50-300 ml.
+
+Hysterosalpingography:
+
+- Adult: 240 mg iodine/ml: 15-20 ml; 300 mg iodine/ml: 15-20 ml.
+
+Arthrography:
+
+- Adult: Knee: 240 mg iodine/ml: 5-15 ml; 300 mg iodine/ml: 5-15 ml; 350 mg iodine/ml: 5-10 ml. Shoulder: 240 mg iodine/ml: 3 ml; 300 mg iodine/ml: 10 ml. Temporomandibular: 300 mg iodine/ml: 0.5-1 ml. Lower volumes are recommended for double-contrast examinations; higher volumes are recommended fro single-contrast examinations.
+
+Herniography:
+
+- Adult: 240 mg iodine/ml: 50 ml.
+
+Excretory urography:
+
+- Adult: Use 300 or 350 mg iodine/ml solution: 200-350 mg iodine/kg.
+- Child: Use 300 mg iodine/ml solution: 0.5-3 ml/kg, usual: 1-1.5 ml/kg; max: 3 ml/kg.
+
+Endoscopic retrograde cholangiopancreatography (ERCP), Endoscopic retrograde pancreatography (ERP):
+
+- Adult: Use 240 mg iodine/ml: 10-50 ml.
+
+
Intra-arterial-
+Peripheral arteriography:
+
+- Adult: Aortofemoral runoffs: 350 mg iodine/ml: 20-70 ml; 300 mg iodine/ml: 30-90 ml. Selective arteriograms (femoral/iliac): 350 mg iodine/ml: 10-30 ml; 300 mg iodine/ml: 10-60 ml. Venography (per leg): 240 mg iodine/ml: 20-150 ml; 300 mg iodine/ml: 40-100 ml.
+
+Cerebral arteriography:
+
+- Adult: Use 300 mg iodine/ml solution: Common carotid artery: 6-12 ml; internal carotid artery: 8-10 ml; external carotid artery: 6-9 ml; vertebral artery: 6-10 ml.
+
+Digital subtraction angiography:
+
+- Adult: Use 140 mg iodine/ml solution: Aorta: 20-45 ml at 8-20 ml/sec; carotid: 5-10 ml at 3-6 ml/sec; femoral: 9-20 ml at 3-6 ml/sec; vertebral: 4-10 ml at 2-8 ml/sec; renal: 6-12 ml at 3-6 ml/sec; other branches of the aorta (includes subclavian, axillary, innominate and iliac): 8-25 ml at 3-10 ml/sec.
+
+
Intrathecal-
+Contrast-enhanced computerized tomography:
+
+- Adult: Lumbar (via lumbar inj): 180 mg iodine/ml: 10-17 ml; 240 mg iodine/ml: 7-12.5 ml. Thoracic (via lumbar or cervical inj): 240 mg iodine/ml: 6-12.5 ml; 300 mg iodine/ml: 6-10 ml. Cervical (via lumbar inj): 240 mg iodine/ml: 6-12.5 ml; 300 mg iodine/ml solution: 6-10 ml. Cervical (via C1-2 inj): 180 mg iodine/ml: 7-10 ml; 240 mg iodine/ml: 6-12.5 ml; 300 mg iodine/ml: 4-10 ml. Total columnar (via lumbar inj): 240 mg iodine/ml: 6-12.5 ml; 300 mg iodine/ml: 6-10 ml.
+- Child: Use 180 mg iodine/ml solution. 0-<3 mth: 240 ml; 3-<36 mth: 4-8 ml; 3-<7 yr: 5-10 ml; 7-<13 yr: 5-12 ml; 13-18 yr: 6-15 ml.
+
+
Intravenous-
+Contrast-enhanced computerized tomography of the abdomen:
+
+- Adult: In conjunction with dilute oral admin, use 300 mg iodine/ml solution: 100-150 ml. The oral dose is administered 20-40 min prior to IV dose and image acquisition.
+- Child: In conjunction with dilute oral admin, use 240 or 300 mg iodine/ml solution: 1-2 ml/kg; max 3 ml/kg. The oral dose is administered 30-60 min prior to IV dose and image acquisition.
+
+Digital subtraction angiography:
+
+- Adult: 350 mg iodine/ml: 30-50 ml, as a bolus at 7.5-30 ml/second using a pressure injector, usually for 3 or more inj; max: 250 ml.
+
+Contrast-enhanced computerized tomography:
+
+- Adult: Head imaging by inj: 300 mg iodine/ml: 70-150 ml; 350 mg iodine/ml: 80 ml. Head imaging by infusion: 240 mg iodine/ml: 120-250 ml. Body imaging by inj: 300 mg iodine/ml: 50-200 ml; 350 mg iodine/ml: 60-100 ml.
+- Child: Head imaging: 240 or 300 mg iodine/ml: 1-2 ml/kg. Max: 28 g iodine with 240 mg iodine/ml solution or 35 g iodine with 300 mg iodine/ml solution.
+
","Dose and strength used depends on the procedure and route of administration.
","Use of contrast media may result in a transient impairment of renal function and this may precipitate lactic acidosis in diabetics who are taking metformin (see Warnings and Precautions). Patients treated with interleukin-2 less than two weeks previously have been associated with an increased risk for delayed reactions (flu-like symptoms or skin reactions). All iodinated contrast media may interfere with tests on thyroid function, thus the iodine binding capacity of the thyroid may be reduced for up to several weeks. High concentrations of contrast media in serum and urine can interfere with laboratory tests for bilirubin, proteins or inorganic substances (e.g. iron, copper, calcium and phosphate). These substances should therefore not be assayed on the day of examination.
","Manifest thyrotoxicosis. History of serious reaction to Iohexol.
","Flushing or a sensation of heat; pain, extravasation, thrombophlebitis at the inj site; nausea, vomiting, headache, and dizziness; urticaria, pruritus, pallor, sweating, metallic taste, weakness, coughing, rhinitis, sneezing, lachrymation, visual disturbances; hypotension, tachycardia, bradycardia, transient ECG abnormalities, haemodynamic disturbances; dyspnoea, bronchospasm, angioedema, severe urticaria; convulsions, paraesthesia, paralysis; acute renal failure; thromboembolism, disseminated intravascular coagulation, thrombocytopenia; hyperthyroidism, thyroid storm thyrotoxicosis.
","Use in Pregnancy: The safety of Iohexol for use in human pregnancy has not been established. An evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to reproduction, development of the embryo or foetus, the course of gestation and peri- and postnatal development. Since whenever possible, radiation exposure should be avoided during pregnancy, the benefits of an X-ray examination, with or without contrast media, should be carefully weighed against the possible risk. Iohexol should not be used in pregnancy unless the benefit outweighs the risk and it is considered essential by the physician.
Use during Lactation: Breast feeding may be continued normally when iodinated contrast media are given to the mother.
","A positive history of allergy, asthma, or untoward reactions to iodinated contrast media indicates a need for special caution. Premedication with corticosteroids or histamine H1 and H2 antagonists might be considered in these cases. The risk of serious reactions in connection with use of Iohexol is regarded as minor. However, iodinated contrast media may provoke anaphylactoid reactions or other manifestations of hypersensitivity. A course of action should therefore be planned in advance, with necessary drugs and equipment available for immediate treatment, should a serious reaction occur. It is advisable always to use an indwelling cannula or catheter for quick intravenous access throughout the entire X-ray procedure. Non-ionic contrast media have less effect on the coagulation system in vitro, compared to ionic contrast media. When performing vascular catheterisation procedures one should pay meticulous attention to the angiographic technique and flush the catheter frequently (e.g.: with heparinised saline) so as to minimise the risk of procedure-related thrombosis and embolism. Adequate hydration should be assured before and after contrast media administration. This applies especially to patients with multiple myeloma, diabetes mellitus, renal dysfunction, as well as to infants, small children and elderly patients. Young infants (age < 1 year) and especially neonates are susceptible to electrolyte disturbance and haemodynamic alterations. Care should also be taken in patients with serious cardiac disease and pulmonary hypertension as they may develop haemodynamic changes or arrhythmias. Patients with acute cerebral pathology, tumours or a history of epilepsy are predisposed for seizures and merit particular care. Also alcoholics and drug addicts have an increased risk for seizures and neurological reactions. A few patients have experienced a temporary hearing loss or even deafness after myelography, which is believed to be due to a drop in spinal fluid pressure by the lumbar puncture per se. To prevent acute renal failure following contrast media administration, special care should be exercised in patients with pre-existing renal impairment and diabetes mellitus as they are at risk. Patients with paraproteinemias (myelomatosis and Waldenström's macroglobulinemia) are also at risk
",,"Preclinical data indicate a high safety margin for Iohexol and no fixed upper dose level has been established for routine intravascular use. Symptomatic overdosing is unlikely in patients with normal renal function unless the patient has received an excess of 2000 mg I/kg body-weight over a limited period of time. The duration of the procedure is important for the renal tolerability of high doses of contrast media (t½ ~ 2 hours). Accidental overdosing is most likely following complex angiographic procedures in children, particularly when multiple injections of contrast medium with high-concentration are given. In cases of overdose, any resulting water or electrolyte imbalance must be corrected. Renal function should be monitored for the next 3 days. If needed, haemodialysis may be used for clearance of excessive contrast medium. There is no specific antidote.
",,"Like all parenteral products, Iohexol should be inspected visually for particulate matter, discoloration and the integrity of the container prior to use. The product should be drawn into the syringe immediately before use. Vials are intended for single use only, any unused portions must be discarded. The 500 ml contrast medium bottles should only be used in connection with auto injectors/pumps approved for this volume. A single piercing procedure should be used. The line running from the auto injector/pump to the patient must be exchanged after each patient. Any unused portions of the contrast medium remaining in the bottle and all connecting tubes must be discarded at the end of the day. When convenient, smaller bottles can also be used. Instructions from the manufacturer of the auto injector/pump must be followed.
","Store at room temperature below 30° C and protect from light and secondary X-rays. The product in glass vials and bottles may be stored at 37° C for up to 3 months prior to use.Do not freeze.
",13
+1417,Iodixanol,iodixanol-1417,https://medex.com.bd/attachments/ITiRfkuPeaiMmYcrD5UsveO1aM5mWk/iodixanol-prescribing-information,Contrast medium for diagnostic procedures,Peripheral venography,"Iodixanol injection is a radiographic contrast agent indicated for the following:
+
Intra-arterial Procedures:
+Adults and pediatric patients 12 years of age and over:
+
+- Intra-arterial digital subtraction angiography (270 and 320 mg Iodine/mL).
+- Angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography (320 mg Iodine/mL).
... Read more
Iodixanol injection is a radiographic contrast agent indicated for the following:
+
Intra-arterial Procedures:
+Adults and pediatric patients 12 years of age and over:
+
+- Intra-arterial digital subtraction angiography (270 and 320 mg Iodine/mL).
+- Angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography (320 mg Iodine/mL).
+
+Pediatric patients less than 12 years of age:
+
+- Angiocardiography, cerebral arteriography, and visceral arteriography (320 mg Iodine/mL).
+
+
+
Intravenous Procedures:
+Adults and pediatric patients 12 years of age and over:
+
+- Computed tomography (CT) imaging head and body and excretory urography (270 and 320 mg Iodine/mL).
+- CT imaging peripheral venography (270 mg Iodine/mL).
+- Coronary computed tomography angiography (CCTA) to assist diagnostic evaluation of patients with suspected coronary artery disease (320 mg Iodine/mL).
+
+Pediatric patients less than 12 years of age:
+
+- CT imaging of the head and body and excretory urography (270 mg Iodine/mL).
+
","Contrast medium for diagnostic procedures
","Intravascular injection of iodixanol opacifies vessels in the path of flow of the contrast agent, permitting visualization of internal structures. In imaging of the body, iodinated contrast agents diffuse from the vascular into the extravascular space. In a normal brain with an intact blood-brain barrier, contrast does not diffuse into the extravascular space. In patients with a disrupted bloodbrain barrier, contrast agent accumulates in the interstitial space in the region of disruption.
","Individualize the combination of volume and concentration of Iodixanol Injection considering age, body weight, size of the vessel, rate of blood flow within the vessel, and other applicable factors. For the adult patients, the maximum recommended total dose of iodine is 80 grams. Patients should be adequately hydrated prior to and following the intravascular administration of iodinated contrast agents.
",,,"Not indicated for intrathecal use
","Most common adverse reactions (incidence greater than 0.5%) in adult patients after Iodixanol injection: Discomfort, warmth, pain
Cardiovascular: angina. Gastrointestinal: diarrhea, nausea, vomiting.
Nervous System: agitation, anxiety, insomnia, nervousness, dizziness, headache, migraine, unusual skin sensations, sensory disturbance, fainting, sensation of spinning.
Skin: itchy rash, severe itching, hives.
Special Senses: Smell, taste, and vision alteration. Pediatric patients experienced similar adverse reactions.
","Pregnancy:There are no data with iodixanol use in pregnant women to inform any drug-associated risks.
Lactation: A lactating woman may pump and discard breast milk for 10 hours after Iodixanol administration
","Hypersensitivity Reactions: life-threatening or fatal reactions can occur. Always have emergency equipment and trained personnel available.
Contrast Induced Acute Kidney Injury: Acute injury including renal failure can occur. Minimize dose and maintain adequate hydration to minimize risk.
Cardiovascular reactions: hemodynamic disturbances including shock and cardiac arrest may occur during or after administration.
","Geriatrics: Exercise caution in dose selection for elderly patients
Pediatric Use: The safety and efficacy of Iodixanol have been established in pediatric patients down to birth for angiocardiography, cerebral arteriography, visceral arteriography, CT imaging of the head and body, and excretory urography. The safety and efficacy of Iodixanol have also been established in pediatric patients 12 years and older for intra-arterial digital subtraction angiography, peripheral arteriography, CT imaging peripheral venography and CCTA.
","The adverse effects of overdosage of any contrast agent may be life-threatening and affect mainly the pulmonary and cardiovascular systems. Treatment of an overdosage is directed toward the support of all vital functions and prompt institution of symptomatic therapy. Iodixanol Injection does not bind to plasma or serum protein and can be dialyzed.
",,,"Store Iodixanol at controlled room temperature, 20°C-25°C; excursions permitted to 15°C-30°C
",11
+951,Intravenous Fat Emulsion,intravenous-fat-emulsion-951,https://medex.com.bd/attachments/MX4RUlXhsJZ7pOWrYncdEnZfBNHOJS/intravenous-fat-emulsion-prescribing-information,Parenteral nutritional preparations,Renal impairment,"This is a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time (usually for >5 days). It is a source of essential fatty acids when a deficiency occurs. Part of the intravenous diet in all parenteral nutrition indications including:
... Read more
This is a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time (usually for >5 days). It is a source of essential fatty acids when a deficiency occurs. Part of the intravenous diet in all parenteral nutrition indications including:
Preoperative and postoperative nutritional disturbances where an improved nitrogen balance is required;
Nutritional disorders or disturbances of nitrogen balance due to inadequate or failing intestinal absorption caused by tumours in the gastrointestinal tract, acute or chronic intestinal diseases (peritonitis, ulcerative colitis, terminal ileitis);
Burns, to reduce the frequently excessive nitrogen losses; Prolonged unconsciousness, eg. following cranial trauma or poisoning in cases where enteral feeding is inappropriate or impossible;
Impaired renal function where a concentrated source of energy may be indicated to reduce protein breakdown;
Cachexia and Patients with essential fatty acid deficiency who cannot maintain or restore a normal essential fatty acid pattern by oral intake.
","Parenteral nutritional preparations
","This is a preparation of 10% refined soyabean oil intended to be used as an intravenous nutrient. This prevents Essential Fatty Acid Deficiency (EFAD) and corrects the clinical manifestations of EFAD. However, for patients requiring complete parenteral nutrition, complementary vitamin supplements are required. This are prepared from either soyabean or safflower oil and provide a mixture of neutral triglycerides, predominantly unsaturated fatty acids. The major components of fatty acids are linoleic, oleic, palmitic acids. In addition, This contains 1.2% egg yolk phospholipids as an emulsifier and glycerol to adjust tonicity. IV Fat emulsions are isotonic and may be given by central or peripheral venous route. This is formulated as a concentrated source of energy to be used together with carbohydrates and amino acids in parenteral nutrition, it is isotonic, and provides a source of basal phosphate requirements and a source of vitamin E.
","Total Parenteral nutrition: As a part of TPN, administer IV via a peripheral vein or by central venous catheter. Fat emulsion should comprise no more than 60% of the patient's total caloric intake, with carbohydrates and amino acids comprising the remaining 40% or more of caloric intake. Adult: Initial infusion rate is 1 ml/min for the first 15 to 30 mins. If no adverse reactions occur, the infusion rate can be increased to 2 ml/min. Infuse only 500 ml the first day and increase dose the following day. Do not exceed a daily dosage of 2.5 g/kg. Children: Initial infusion rate is 0.1 ml/min for the first 10 to 15 mins. If no adverse reactions occur, the infusion rate can be increased to 1 g/kg in 4 hours. Do not exceed a daily dosage of 3 g/kg. Infants: Starts at 0.5 g/kg/24 hours and may be increased in relation to the infant's ability to eliminate fat. The maximum recommended dosage is 3 g/kg/24 hours. Fatty acid deficiency: To correct EFAD, supply 8% to 10% of the caloric intake by IV fat emulsion to provide an adequate amount of linoleic acid. Do not store partially used bags for later use. Do not use filters. Do not use any bag in which there appears to be separation of the emulsion.
",,"Some drugs, like insulin, may interfere with the body's lipase system. This kind of interaction seems, however, to be of only limited clinical importance. Heparin in clinical doses causes a transient increase in lipolysis in plasma, resulting in a transient decrease in triglyceride clearance due to depletion of lipoprotein lipase.
","This is contraindicated in conditions with severely disordered fat metabolism, such as in severe liver damage and acute shock. Hypersensitivity to egg-, soya- or peanut protein or to any of active substances or excipients.
","This IV infusion may cause a rise in body temperature (incidence <3%) and, less frequently, shivering, chills and nausea/vomiting (incidence <1%). Reports of other adverse events in conjunction with 10% fat emulsion infusion are extremely rare, less than one report of certain events per one million infusions. Hypersensitivity reactions (anaphylactic reaction, skin rash, urticaria), respiratory symptoms (tachypnoea) and circulatory effects (hypertension, hypotension) have been described. Thrombosis, haemolysis, reticulocytosis, abdominal pain, tiredness, priapism and neurological adverse reactions including headaches, flushing, dyspnoea, slight pressure over the eyes and dizziness have been reported.
","No data found
","This injection contains soya oil and egg lecithin which may rarely cause allergic reactions. Cross allergic reaction has been observed between soya-bean and peanut. Fat metabolism may be disturbed in conditions such as renal insufficiency, uncompensated diabetes, pancreatitis, certain forms of liver insufficiency, metabolic disorders and sepsis. This injection should be administered with caution as a strong correlation exists between C-reactive protein and the agglutination of This injection in seriously ill patients. This injection should be given with caution to neonates and premature infants with hyperbilirubinaemia and in cases with suspected pulmonary hypertension. In low birthweight infants, the risk of lipid infusions may outweigh potential benefits due to further diminution of defences against infection. In infants, metabolism of lipids in peripheral tissues may be diminished by infection and heparin administration. In neonates receiving long term parenteral nutrition, particularly premature neonates, platelet count, liver function tests and serum triglyceride concentration should be monitored. Use in Pregnancy & Lactation: Absolute safety of the foetus and the nursing infant has not been established. Therefore, This injectionTM should be administered with caution during pregnancy and lactation.
",,"Impaired capacity to eliminate this may lead to fat overload syndrome as a result of overdosage. It may also occur at recommended rates of infusion in association with a sudden change in the clinical condition such as renal function impairment or infection. Fat overload syndrome is characterised by bone marrow depression, anaemia, thrombocytopenia, hepatosplenomegaly, splenomegaly, hyperlipaemia, fever, fat infiltration, focal seizures and shock. All symptoms are usually reversible if the infusion of this is discontinued.
",,,"Store at room temperature (not exceeding 25° C). Protect from freezing and light. Emulsion which has been frozen should be discarded. Any remaining emulsion from an opened bag must be discarded. Do not use if the emulsion is discolored. This contains no preservatives.
",11
+619,Interferon Alfa-2a [Recombinant],interferon-alfa-2a-recombinant-619,,Immunological Chemotherapy,Renal cell carcinoma,"Interferon alfa-2a is indicated for the treatment of chronic hepatitis C and hairy cell leukemia in patients 18 years of age or older. In addition, it is indicated for chronic phase, Philadelphia chromosome (Ph) positive chronic myelogenous leukemia (CML) patients who are minimally pretreated ... Read more
Interferon alfa-2a is indicated for the treatment of chronic hepatitis C and hairy cell leukemia in patients 18 years of age or older. In addition, it is indicated for chronic phase, Philadelphia chromosome (Ph) positive chronic myelogenous leukemia (CML) patients who are minimally pretreated (within 1 year of diagnosis).
For Patients With Chronic Hepatitis C: Interferon alfa-2a is indicated for use in patients with chronic hepatitis C diagnosed by HCV antibody and/or a history of exposure to hepatitis C who have compensated liver disease and are 18 years of age or older. A liver biopsyand a serum test for the presence of antibody to HCV should be performed to establish the diagnosis of chronic hepatitis C. Other causes of hepatitis, including hepatitis B, should be excluded prior to therapy with Interferon alfa-2a .
","Immunological Chemotherapy
","Interferon alfa-2a has antiviral, antitumour and immunomodulatory activity. It inhibits replication of a wide range of RNA and DNA viruses. It also exerts antiproliferative effects on normal and malignant cells. Interferon alfa-2a suppresses antibody formation through an effect on B-lymphocytes and inhibits onset of delayed hypersensitivity.
","Renal cell carcinoma: In an escalating dose of 3 million unit 3 times/week for 1 week, then 9 million unit 3 times/week for 1 week, then 18 million unit 3 times/week thereafter for 3-12 month.
Chronic hepatitis B: 2.5-5 million unit/m2 3 times/week for 4-6 month. Chronic hepatitis C with ribavirin: 3-4.5 million unit 3 times/week for 6 month. Monotherapy: 3 million unit 3 times/ week for 12 month. Hairy cell leukaemia 3 million unit/day for 16-24 week. Maintenance: 3 million unit 3 times/week, up to 24 week.
AIDS related Kaposi's sarcoma: In an escalating dose of 3 million unit/day for 3 days, 9 million unit/day for 3 days, 18 million unit/day for 3 days, and 36 million unit/day (if tolerated) on days 10-84. thereafter max tolerated dose (up to 36 million u) 3 times/week.
Chronic myeloid leukaemia: In an escalating dose of 3 million unit/day for 3 days, 6 million unit/day for 3 days, and 9 million unit/day thereafter. For responders after 12 week: Continue treatment until haematological response is complete or up to 18 month. Follicular lymphoma As adjunct to chemotherapy: 6 million unit/m2/day on days 22-26 of each 28-day cycle.
Cutaneous T-cell lymphoma: In an escalating dose of 3 million unit/day for 3 days, then 9 million unit/day for 3 days, and then 18 million unit/day to complete 12 week of treatment. Thereafter, max tolerated dose (up to 18 million unit) 3 times/week for at least 12 month in responders.
Melanoma: 3 million unit 3 times/week for 18 month. Start treatment no later than 6 week after surgery.
",,"Reduces clearance of theophylline. Enhanced myelosuppression with other myelosuppressive drugs (e.g. zidovudine). Drugs metabolised by CYP450 pathway (monitor for changes in pharmacologic or adverse effects of concomitant drug). Increased risk of toxicity of centrally acting drugs. Increased risk of renal failure with interleukin-2.
","Interferon Alfa-2a is contraindicated in
+
+- patients with a history of hypersensitivity to recombinant interferon alfa-2a or any component of the preparation.
+- patients with severe pre-existing cardiac disease or with any history of cardiac illness. No direct cardiotoxic effect has been demonstrated, but it is likely that acute, self-limiting toxicities (e.g. fever, chills) frequently associated with administration of Interferon Alfa-2a may exacerbate pre-existing cardiac conditions.
+- severe renal, hepatic or myeloid dysfunction.
+- seizure disorders and/or compromised central nervous system function.
+- chronic hepatitis with advanced, decompensated hepatic disease.
+- chronic hepatitis patients who are being or have recently been treated with immunosuppressive agents, excluding short-term ""steroid withdrawal"".
+- CML patients with an HLA-identical relative who are potential candidates for allogeneic bone marrow transplantation in the immediate future.
+- neonates, children up to 3 years, and premature infants. Interferon Alfa-2a solution for injection contains benzyl alcohol. There have been reports of permanent neuropsychiatric deficits and multiple system organ failure associated with benzyl alcohol.
+
","Depressive illness, suicidal behaviour, irritability, insomnia, anxiety. Flu-like symptoms. Headache, dizziness, paraesthesia, confusion, impaired concentration, alteration in taste or smell. Gl disturbances. Dryness of oropharynx, epistaxis, rhinitis, arrhythmia, sinusitis. Inj site reaction, alopecia, rash, dry skin or pruritus. Conjunctivitis, menstrual irregularity, visual disturbances. Coughing, dyspnoea. Myalgia, joint or bone pain, arthritis or polyarthritis. Bone marrow depression.
","Pregnancy Category: Interferon Alfa-2a should be administered only if the benefit to the woman justifies the potential risk to the foetus. Although animal tests do not indicate that Roferon-A is a teratogen, harm to the foetus from use during pregnancy cannot be excluded. When doses greatly in excess of the recommended clinical dose were administered to pregnant rhesus monkeys in the early to mid foetal period, an abortifacient effect was observed.
Nursing mothers: It is not known whether Interferon Alfa-2a is secreted in human milk. A decision must be taken whether to suspend breast-feeding or to discontinue the medicine, taking into account the importance of the medicine to the mother.
","History of depression (monitor for signs). Perform regular neuropsychiatric monitoring. Seizure disorders and/or compromised CNS function. Preexisting or any history of cardiac disease. Monitor CBC prior to and during therapy. Myelosuppression or concurrent use of myelosuppressive drugs. Hypothyroidism, hyperthyroidism, DM. Perform ophthalmological exam on patients with preexisting ophthalmologic disorders (e.g. diabetic or hypertensive retinopathy). Monitor patients with impaired renal function.
",,,,,,9
+617,Insulin Lispro Protamine + Insulin Lispro,insulin-lispro-protamine-insulin-lispro-617,https://medex.com.bd/attachments/eCUYWgfUiDhWCNsikFtUkw4W5N747t/insulin-lispro-protamine-insulin-lispro-75-25-prescribing-information,Combination Insulin,Type 1 DM,"A mixture of 75% insulin lispro protamine suspension and 25% insulin lispro injection, (rDNA origin), is indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia.
A mixture of 50% insulin lispro protamine suspension and 50% insulin lispro injection, (rDNA ... Read more
A mixture of 75% insulin lispro protamine suspension and 25% insulin lispro injection, (rDNA origin), is indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia.
A mixture of 50% insulin lispro protamine suspension and 50% insulin lispro injection, (rDNA origin), is also indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia.
","Combination Insulin
","Insulin lispro is a short-acting biosynthetic human insulin analogue. Insulin lispro protamine is an intermediate-acting glucose-lowering agent; it is a suspension of crystals produced from combining insulin lispro and protamine sulfate under appropriate conditions for crystal formation. They are used together for the regulation of glucose metabolism.
","Combination rapid-onset (faster than regular insulin) and intermediate-acting insulins in fixed dose. Dose regimen varies among patients depending on metabolic needs; typical daily insulin requirements range between 0.5-1 unit/kg
",,"Effects may be increased by: oral antidiabetic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAOIs, propoxyphene, salicylates, somatostatin analog (e.g., octreotide), sulfonamide antibiotics. Effects may be decreased by: corticosteroids, niacin, danazol, diuretics, sympathomimetic agents, isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, oral contraceptives, lithium. Signs of hypoglycaemia may be masked by beta-blockers, clonidine.
","Insulin Lispro Protamine & Insulin Lispro is contraindicated during episodes of hypoglycemia and in patients sensitive to insulin lispro or any of the excipients contained in the formulation
","Hypoglycaemia; hypokalemia, oedema; pruritus; pulpitation, nausea, rash; hypersensitivity reactions; lipoatropy or lipohypertrophy with SC Inj.
","Pregnancy Category B. Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
Lactation: Unknown whether distributed in breast milk; compatible with breast feeding, but lactating women may require dosage adjustment; caution advised
","Renal or hepatic impairment; pregnancy, lactation; transferring from other insulin. Monitor serum glucose, potassium, electrolytes, HbA1c and lipid profile. Concomitant illness esp infections.
",,,,,"Store at 2-8° C in a refrigerator. Do not freeze. In case of insulin for recent use need not be refrigerated, try to keep it in a cool place and keep away from heat and light. The insulin in use can be kept under the room temperature for a month.
",10
+616,Insulin Lispro,insulin-lispro-616,https://medex.com.bd/attachments/emX2iouS4YepbpDvysXy7dsdnioYOc/insulin-lispro-prescribing-information,Rapid Acting Insulin,Type 1 DM,"Insulin Lispro is an insulin analogue that is indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. Insulin Lispro has a more rapid onset and a shorter duration of action than human regular insulin. Therefore, in patients with type 1 diabetes, Insulin Lispro ... Read more
Insulin Lispro is an insulin analogue that is indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. Insulin Lispro has a more rapid onset and a shorter duration of action than human regular insulin. Therefore, in patients with type 1 diabetes, Insulin Lispro should be used in regimens that include a longer-acting insulin. However, in patients with type 2 diabetes, Insulin Lispro may be used without a longer-acting insulin when used in combination therapy with sulfonylurea agents.
","Rapid Acting Insulin
","Insulin Lispro (insulin lispro, rDNA origin) is a human insulin analogue that is a rapid-acting, parenteral blood glucose-lowering agent. Chemically, it is Lys(B28), Pro(B29) human insulin analogue, created when the amino acids at positions 28 and 29 on the insulin B -chain are reversed. Insulin Lispro is synthesized in a special non-pathogenic laboratory strain of Escherichia coli bacteria that has been genetically altered by the addition of the gene for insulin lispro. The blood glucose lowering effect of insulin lispro is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
","Adult: SC Dosing regimen should be individualised and adjusted based on patient's glycaemic response. Usual range is 0.5-1 unit/kg/day.
Type 1 diabetes mellitus: Approximately one third of the total daily insulin requirements SC; rapid-acting or short-acting, premeal insulin should be used to satisfy the remainder of the daily insulin requirements
Usual daily maintenance range: 0.5-1 unit/kg/day in divided doses; nonobese may require 0.4-0.6 unit/kg/day; obese may require 0.8-1.2 units/kg/day
Type 2 diabetes mellitus: If inadequately controlled with oral medication: 10 units/day SC (or 0.1 -0.2 unit/kg/day) of intermediate- or long-acting insulin given at bedtime generally recommended; as an alternative, rapid-acting formulations, such as insulin lispro, given before meals have also been used; dose must be adjusted carefully.
",,"Insulin requirements may be increased by medications with hyperglycemic activity such as corticosteroids, isoniazid, certain lipid-lowering drugs (e.g., niacin), estrogens, oral contraceptives, phenothiazines, and thyroid replacement therapy. Insulin requirements may be decreased in the presence of drugs that increase insulin sensitivity or have hypoglycemic activity, such as oral antidiabetic agents, salicylates, sulfa antibiotics, certain antidepressants (monoamine oxidase inhibitors), angiotensin-converting-enzyme inhibitors, Angiotensin II receptor blocking agents, beta-adrenergic blockers, inhibitors of pancreatic function (e.g., octreotide), and alcohol. Beta-adrenergic blockers may mask the symptoms of hypoglycemia in some patients.
","Insulin Lispro is contraindicated by patients hypersensitivity to insulin lispro or the other excipients.
","Clinical studies comparing Insulin Lispro with Regular human insulin did not demonstrate a difference in frequency of adverse events between the two treatments. Adverse events commonly associated with human insulin therapy include the following: Body as a Whole: allergic reactions. Skin and Appendages: injection site reaction, lipodystrophy, pruritus, rash. Other: hypoglycemia.
","Pregnancy Category B. All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. This background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is essential for patients with diabetes or history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. In patients with diabetes or gestational diabetes insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring of glucose control is essential in these patients. Therefore, female patients should be advised to tell their physicians if they intend to become, or if they become pregnant while taking Insulin Lispro.
Nursing Mothers: It is unknown whether insulin lispro is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when insulin lispro is administered to a nursing woman. Use of insulin lispro is compatible with breastfeeding, but women with diabetes who are lactating may require adjustments of their insulin doses.
","Renal or hepatic impairment; pregnancy, lactation; transferring from other insulin. Monitor serum glucose, potassium, electrolytes, HbA1c and lipid profile. Concomitant illness esp infections.
","Pediatric Use: Insulin Lispro is approved for use in children for subcutaneous daily injections. Only the U-100 formulation of Insulin Lispro is approved for use in children by continuous subcutaneous infusion in insulin pumps. Insulin Lispro has not been studied in pediatric patients younger than 3 years of age. Insulin Lispro has not been studied in pediatric patients with type 2 diabetes. As in adults, the dosage of Insulin Lispro must be individualized in pediatric patients based on metabolic needs and results of frequent monitoring of blood glucose.
Geriatric Use: Of the total number of subjects (n=2834) in eight clinical studies of Insulin Lispro, twelve percent (n=338) were 65 years of age or over. The majority of these had type 2 diabetes. HbA1c values and hypoglycemia rates did not differ by age. Pharmacokinetic/pharmacodynamic studies to assess the effect of age on the onset of Insulin Lispro action have not been performed.
Renal Impairment: Patients with renal impairment may be at increased risk of hypoglycemia and may require more frequent Insulin Lispro dose adjustment and more frequent blood glucose monitoring.
Hepatic Impairment: Patients with hepatic impairment may be at increased risk of hypoglycemia and may require more frequent Insulin Lispro dose adjustment and more frequent blood glucose monitoring
","Excess insulin administration may cause hypoglycemia and hypokalemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.
",,,"Store at 2°C - 8°C in a refrigerator. Do not freeze. In case of insulin for recent use need not be refrigerated, try to keep it in a cool place and keep away from heat and light. The insulin in use can be kept under the room temperature for a month.
",12
+1225,Insulin Human [rDNA] + Isophane Insulin Human,insulin-human-rdna-isophane-insulin-human-1225,https://medex.com.bd/attachments/O5EU0UnQ04SZJLGmm82b1s6El00fdN/insulin-human-rdna-isophane-insulin-human-prescribing-information,Medium Acting Insulin,Type 1 DM,"Treatment of all patients with type 1 diabetes. Treatment of patients with type 2 diabetes who are not adequately controlled by diet and/ or oral hypoglycemic agents.
For the initial stabilization of diabetes in patients with diabetic ketoacidosis, hyperosmolar non-ketotic syndrome and during ... Read more
Treatment of all patients with type 1 diabetes. Treatment of patients with type 2 diabetes who are not adequately controlled by diet and/ or oral hypoglycemic agents.
For the initial stabilization of diabetes in patients with diabetic ketoacidosis, hyperosmolar non-ketotic syndrome and during periods of stress such as severe infections and major surgery in diabetic patients. Treatment of gestational diabetes.
","Medium Acting Insulin
","Insulin Human (rDNA) is human insulin made by recombinant DNA technology. It has the same structure and function as natural insulin. Insulin regulates the glucose metabolism and stimulates the ingestion and utilization of glucose by liver, muscle and fat tissue. It also lowers blood glucose by accelerating glycogenesis and inhibiting gluconeogenesis.
Insulin Human (rDNA) 30/70 & Insulin Human (rDNA) 50/50 start action within 30 minutes after injection, reach peak level within 2-8 hours and last about 24 hours.
","The average range of total daily insulin requirement for maintenance therapy in type 1 diabetic patients lies between 0.5 and 1.0 IU/kg. In pre-pubertal children it usually varies from 0.7 to 1.0 IU/kg, whereas in insulin resistant cases, e.g. during puberty or due to obesity, the daily insulin requirement may be substantially higher. Initial dosages for type 2 diabetic patients are often lower, e.g. 0.3 to 0.6 IU/kg/day.
The dosage form, the dosage and the administration time of the insulin are different due to the individual differences of each patient. In addition, the dosage is also affected by food, working style and exercising intensity. Therefore, patients should use the insulin under doctor's instruction.
","An injection should be followed by a meal or snack containing carbohydrates within 30 minutes. Injection is administered subcutaneously in the upper arm, thigh, buttock or abdominal wall. A subcutaneous injection into the abdominal wall results in a faster absorption than from other injection sites. Insulin Human (rDNA) 30/70 & Insulin Human (rDNA) 50/50 are never to be administered intravenously.
Preparation before use:
+
+- Clean your hands.
+- Shake or rotate the vial gently to mix the solution uniformly and check if the insulin has the normal appearance.
+- In case of using a new vial, flip off the plastic protective cap and wipe the rubber plug with an alcohol swab.
+- Draw air into your syringe equal to the amount of insulin needed.
+- Puncture the needle into the vial and inject the air.
+- Turn the bottle and syringe upside down and withdraw correct dose of insulin into the syringe.
+- Before pulling out the needle, check if there are any bubbles remain in the syringe. If so, put the syringe upright and tap the syringe to discharge the air bubbles.
+
+Injection site:
+
+- Choose the area where skin is less tight, such as the upper arm, thigh, buttock or abdomen.
+- To avoid tissue damage, choose a site for each injection that is at least 1 cm from the previous injection site.
+
+Injection method:
+
+- Cleanse the skin with alcohol where the injection is to be made.
+- Put the needle in such a position as to form 45° angle with the skin.
+- Puncture the needle into skin and inject insulin.
+- Keep the needle under the skin for at least 6 seconds to make sure the entire dose is injected.
+- Pull the needle out and apply gentle pressure over the injected site for several seconds.
+- Do not rub the injection site.
+
","When using oral contraceptive drug, adrenal cortical hormone, thyroid hormone, etc., the drugs that can result in the rise of blood glucose; you might need to increase the amount of Insulin. When using drugs with hypoglycemic activities, salicylate, sulfanilamide and other anti-depressants, which will result in the decrease of blood glucose, the dosage of insulin should be reduced.
","Hypoglycemia or the patients who have allergic reaction to insulin or any of the excipients.
","Hypoglycemia is the most common adverse effect during insulin treatment and symptoms of hypoglycemia may occur suddenly. Few cases of the allergic reaction such as red and swollen or itching are reported. It usually disappears in a few days. In some instances, the allergy may be caused by other reasons rather than insulin, such as disinfectant and poor injection technique.
","There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not pass the placental barrier. Insulin treatment of the nursing mother presents no risk to the baby.
","Inadequate dosing or discontinuation especially in type 1 diabetes, may lead to hyperglycemia. Hypoglycemia may occur if the insulin dose is too high in relation to the insulin requirement. Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycemia.
",,"Excessive use of insulin may lead to hypoglycemia during the treatment. Slight to moderate hypoglycemia may suddenly occur. It is important to get immediate treatment when hypoglycemia occurs. If you have frequent hypoglycemia, you should consult your doctor to discuss possible changes in therapy, diet plans, and/or exercise programs to help you avoid hypoglycemia.
",,,"Store at 2°C - 8°C in a refrigerator. Do not freeze. In case of insulin for recent use need not be refrigerated, try to keep it in a cool place and keep away from heat and light. The insulin in use can be kept under the room temperature for a month.
",12
+608,Insulin Human [Long-Acting],insulin-human-long-acting-608,https://medex.com.bd/attachments/6pWZgBFWLheDWUqcWIUnuiXxaqv2MX/insulin-human-long-acting-prescribing-information,Long Acting Insulin,Type 1 DM,"Treatment of all patients with type 1 diabetes. Treatment of patients with type 2 diabetes who are not adequately controlled by diet and/ or oral hypoglycemic agents. For the initial stabilization of diabetes in patients with diabetic ketoacidosis, hyperosmolar non-ketotic syndrome and during periods ... Read more
Treatment of all patients with type 1 diabetes. Treatment of patients with type 2 diabetes who are not adequately controlled by diet and/ or oral hypoglycemic agents. For the initial stabilization of diabetes in patients with diabetic ketoacidosis, hyperosmolar non-ketotic syndrome and during periods of stress such as severe infections and major surgery in diabetic patients. Treatment of gestational diabetes.
","Long Acting Insulin
","The blood glucose lowering effect of insulin is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver. Insulatard is a long-acting insulin. Onset of action is within 1½ hours, reaches a maximum effect within 4-12 hours and the entire time of duration is approximately 24 hours.
Insulin in the blood stream has a half-life of a few minutes. Consequently, the time-action profile of an insulin preparation is determined solely by its absorption characteristics. This process is influenced by several factors (e.g. insulin dosage, injection route and site, thickness of subcutaneous fat, type of diabetes). The pharmacokinetics of insulins is therefore affected by significant intra- and inter-individual variation
","Dosage is individual and determined in accordance with the needs of the patient. The individual insulin requirement is usually between 0.3 and 1.0 IU/kg day. The daily insulin requirement may be higher in patients with insulin resistance (e.g. during puberty or due to obesity) and lower in patients with residual, endogenous insulin production.
The physician determines one or several daily injections are necessary. Insulatard may be used alone or mixed with fast-acting insulin. In intensive insulin therapy the suspension may be used as basal insulin (evening and/or morning injection) with fast-acting insulin given at meals. In patients with diabetes mellitus optimised glycaemic control delays the onset of late diabetic complications. Close blood glucose monitoring is recommended.
","For subcutaneous use. Insulatard is usually administered subcutaneously in the thigh. If convenient, the abdominal wall, the gluteal region or the deltoid region may also be used. Subcutaneous injection into the thigh results in a slower and less variable absorption compared to the other injection sites. Injection into a lifted skin fold minimises the risk of unintended intramuscular injection.
Keep the needle under the skin for at least 6 seconds to make sure the entire dose is injected. Injection sites should be rotated within an anatomic region in order to avoid lipodystrophy. Insulin suspensions are never to be administered intravenously. Insulatard is accompanied by a package leaflet with detailed instruction for use to be followed. The vials are for use with insulin syringes with corresponding unit scale. When two types of insulin are mixed, draw the amount of fast-acting insulin first, followed by the amount of long-acting insulin
","A number of medicinal products are known to interact with the glucose metabolism. Physicians must therefore take possible interactions into account and should always ask their patients about any medicinal products they take.
The following substances may reduce insulin requirement: Oral hypoglycaemic agents (OHA), monoamine oxidase inhibitors (MAOI), non-selective beta-blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates and alcohol.
The following substances may increase insulin requirement: Thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol. Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia. Octreotide/lanreotide may both decrease and increase insulin requirement. Alcohol may intensify and prolong the hypoglycaemic effect of insulin.
","Hypoglycaemia, Hypersensitivity to human insulin or to any of the excipients
","Hypoglycemia is the most common adverse effect during insulin treatment and symptoms of hypoglycemia may occur suddenly. Few cases of the allergic reaction such as red and swollen or itching are reported. It usually disappears in a few days. In some instances, the allergy may be caused by other reasons rather than insulin, such as disinfectant and poor injection technique.
","There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not pass the placental barrier.
","Inadequate dosage or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia. Usually the first symptoms of hyperglycaemia set in gradually, over a period of hours or days. They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite as well as acetone odour of breath In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal. Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia. Patients whose blood glucose control is greatly improved e.g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and should be advised accordingly Usual warning symptoms may disappear in patients with longstanding diabetes.
",,"A specific overdose of insulin cannot be defined. However, hypoglycaemia may develop over sequential stages
",,,"Store in a refrigerator (2°C-8°C). Do not freeze. Keep the container cartridge or vial in the outer carton in order to protect from light.
During use: do not refrigerate. Do not store vials above 25°C and cartridges above 30°C. Protect from excessive heat and sunlight.
",12
+1563,Insulin Human [Fast-Acting],insulin-human-fast-acting-1563,https://medex.com.bd/attachments/jxUPkW3CCHIwegNoAOJNzYVD29qd12/insulin-human-fast-acting-prescribing-information,Rapid Acting Insulin,Type 1 DM,"Treatment of all patients with type 1 diabetes. Treatment of patients with type 2 diabetes who are not adequately controlled by diet and/ or oral hypoglycemic agents. For the initial stabilization of diabetes in patients with diabetic ketoacidosis, hyperosmolar non-ketotic syndrome and during periods ... Read more
Treatment of all patients with type 1 diabetes. Treatment of patients with type 2 diabetes who are not adequately controlled by diet and/ or oral hypoglycemic agents. For the initial stabilization of diabetes in patients with diabetic ketoacidosis, hyperosmolar non-ketotic syndrome and during periods of stress such as severe infections and major surgery in diabetic patients. Treatment of gestational diabetes.
","Rapid Acting Insulin
","The blood glucose lowering effect of insulin is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver. Insulatard is a long-acting insulin. Onset of action is within 1½ hours, reaches a maximum effect within 4-12 hours and the entire time of duration is approximately 24 hours.
Insulin in the blood stream has a half-life of a few minutes. Consequently, the time-action profile of an insulin preparation is determined solely by its absorption characteristics. This process is influenced by several factors (e.g. insulin dosage, injection route and site, thickness of subcutaneous fat, type of diabetes). The pharmacokinetics of insulins is therefore affected by significant intra- and inter-individual variation
","Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure. Eat a meal or snack containing carbohydrates within 30 minutes of the injection to avoid low blood sugar. Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.
","For subcutaneous use. Insulatard is usually administered subcutaneously in the thigh. If convenient, the abdominal wall, the gluteal region or the deltoid region may also be used. Subcutaneous injection into the thigh results in a slower and less variable absorption compared to the other injection sites. Injection into a lifted skin fold minimises the risk of unintended intramuscular injection.
Keep the needle under the skin for at least 6 seconds to make sure the entire dose is injected. Injection sites should be rotated within an anatomic region in order to avoid lipodystrophy. Insulin suspensions are never to be administered intravenously. Insulatard is accompanied by a package leaflet with detailed instruction for use to be followed. The vials are for use with insulin syringes with corresponding unit scale. When two types of insulin are mixed, draw the amount of fast-acting insulin first, followed by the amount of long-acting insulin.
",,,"Low blood sugar (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 people.
Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
","If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. This insulin can be used during pregnancy. Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby. There are no restrictions on treatment with this insulin during breast-feeding.
","
+- If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.
+- If you exercise more than usual or if you want to change your usual diet, as this may affect your blood sugar level.
+- If you are ill, carry on taking your insulin and consult your doctor.
+- If you are going abroad, travelling over time zones may affect your insulin needs and the timing hereof.
+
","Use in children and adolescents: Can be used in children and adolescents.
Use in special patient groups: If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.
",,,,"Store in a refrigerator at 2°C-8°C. Keep away from the cooling element. Do not freeze.
",10
+615,Insulin Glulisine,insulin-glulisine-615,https://medex.com.bd/attachments/bX0RDfMm0lpm9Sju7TAEpDd39TOxNM/insulin-glulisine-prescribing-information,Rapid Acting Insulin,Type 1 DM,"Insulin Glulisine is indicated to improve glycemic control in adults and children with diabetes mellitus.
","Rapid Acting Insulin
","Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including insulin glulisine. Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, and enhance protein synthesis. The glucose lowering activities of Insulin Glulisine and of regular human insulin are equipotent when administered by the intravenous route. After subcutaneous administration, the effect of Insulin Glulisine is more rapid in onset and of shorter duration compared to regular human insulin.
","Insulin Glulisine is a recombinant insulin analog that is equipotent to human insulin (i.e. one unit of Insulin Glulisine has the same glucose lowering effect as one unit of regular human insulin) when given intravenously. When given subcutaneously, Insulin Glulisine has a more rapid onset of action and a shorter duration of action than regular human insulin.
The dosage of Insulin Glulisine must be individualized. Blood glucose monitoring is essential in all patients receiving insulin therapy. The total daily insulin requirement may vary and is usually between 0.5 to 1 Unit/kg/day. Insulin requirements may be altered during stress, major illness, or with changes in exercise, meal patterns, or coadministered drugs.
","Subcutaneous administration: Insulin Glulisine should be given within 15 minutes before a meal or within 20 minutes after starting a meal. Insulin Glulisine given by subcutaneous injection should generally be used in regimens with an intermediate or long acting insulin. Insulin Glulisine should be administered by subcutaneous injection in the abdominal wall, thigh, or upper arm. Injection sites should be rotated within the same region (abdomen, thigh or upper arm) from one injection to the next to reduce the risk of lipodystrophy
Continuous subcutaneous infusion (insulin pump): Insulin Glulisine may be administered by continuous subcutaneous infusion in the abdominal wall. Do not use diluted or mixed insulins in external insulin pumps. Infusion sites should be rotated within the same region to reduce the risk of lipodystrophy. The initial programming of the external insulin infusion pump should be based on the total daily insulin dose of the previous regimen.
Intravenous administration: Insulin Glulisine can be administered intravenously under medical supervision for glycemic control with close monitoring of blood glucose and serum potassium to avoid hypoglycemia and hypokalemia. For intravenous use, Insulin Glulisine should be used at concentrations of 0.05 Units/mL to 1 Unit/mL insulin glulisine in infusion systems using polyvinyl chloride (PVC) bags. Insulin Glulisine has been shown to be stable only in normal saline solution (0.9% sodium chloride). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer insulin mixtures intravenously.
","Possible absence of hypoglycaemic warning symptoms with beta-blockers. Decreased hypoglycaemic effect with corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, phenothiazine derivatives, somatropin, sympathomimetic agents, thyroid hormones, oestrogens, progestins (e.g. in oral contraceptives), protease inhibitors and atypical antipsychotics (e.g. olanzapine and clozapine). Increased hypoglycaemic effect with oral antidiabetic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics. Decreased insulin resistance with octreotide and lanreotide. Increased risk of wt gain and peripheral oedema with pioglitazone, rosiglitazone. Decreased effect of sermorelin.
","Insulin Glulisine is contraindicated during episodes of hypoglycemia, in patients who are hypersensitive to Insulin Glulisine or to any of its excipients.
When used in patients with known hypersensitivity to Insulin Glulisine or its excipients, patients may develop localized or generalized hypersensitivity reactions
","Some times severe, life-threatening allergic reactions can happen with insulin. If you think you are having a severe allergic reaction, get medical help right away. Signs of insulin allergy include:
+
+- rash all over your body
+- shortness of breath
+- wheezing (trouble breathing)
+- fast pulse
+- sweating
+- low blood pressure
+
","Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Nursing mothers: It is unknown whether insulin glulisine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Insulin Glulisine is administered to a nursing woman. Use of Insulin Glulisine is compatible with breast feeding, but women with diabetes who are lactating may require adjustments of their insulin doses.
","Renal or hepatic impairment. Regular monitoring of blood glucose and HbA1c. Rotate Inj sites to reduce lipodystrophy . Pregnancy, lactation.
","Pediatric use: The safety and effectiveness of subcutaneous injections of Insulin Glulisine have been established in pediatric patients (age 4 to 17 years) with type 1 diabetes. Insulin Glulisine has not been studied in pediatric patients with type 1 diabetes younger than 4 years of age and in pediatric patients with type 2 diabetes. As in adults, the dosage of Insulin Glulisine must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucose
Geriatric use: In clinical trials (n=2408), Insulin Glulisine was administered to 147 patients ≥65 years of age and 27 patients ≥75 years of age. The majority of this small subset of elderly patients had type 2 diabetes. The change in HbA1c values and hypoglycemia frequencies did not differ by age. Nevertheless, caution should be exercised when Insulin Glulisine is administered to geriatric patients.
Renal impairment: Dose reduction may be needed
Hepatic impairment: Dose reduction may be needed
","Excess insulin may cause hypoglycemia and, particularly when given intravenously, hypokalemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.
",,,"Unopened Insulin Glulisine vials and cartridge systems should be stored in a refrigerator 2°C-8°C. Protect from light. Insulin Glulisine should not be stored in the freezer and it should not be allowed to freeze. Discard if it has been frozen. Unopened vials/cartridge systems not stored in a refrigerator must be used within 28 days.
Opened vials, whether or not refrigerated, must be used within 28 days. If refrigeration is not possible, the open vial in use can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 25°C.
",13
+614,Insulin Glargine [rDNA],insulin-glargine-rdna-614,https://medex.com.bd/attachments/D6veZ4CNHUHoK0HGELV1RSXmA8gy4v/insulin-glargine-rdna-prescribing-information,Long Acting Insulin,Type 1 DM,"Insulin Glargine is indicated to improve glycemic control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
","Long Acting Insulin
","Insulin Glargine is a sterile solution of insulin glargine for use as a subcutaneous injection. Insulin glargine is a recombinant human insulin analogue that is a long-acting (up to 24-hour duration of action), parenteral blood glucose lowering agent. Insulin Glargine is produced by recombinant DNA technology. Primary function of insulin glargine is regulation of glucose metabolism. Insulin and its analogues lower blood glucose by stimulation peripheral glucose uptake, primarily by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis and enhances protein synthesis.
","Insulin Glargine exhibits a relatively constant glucose-lowering profile over 24 hours that permits once-daily dosing. Potency of insulin glargine is approximately the same as human insulin.
Insulin Glargine is recommended for once daily subcutaneous administration & may be administered at any time during the day. However, once started should be administered at the same time every day. The dose of Insulin Glargine must be individualized based on clinical response. Blood glucose monitoring is essential in all patients with diabetes. In patients with type 1 diabetes, Insulin Glargine must be used in regimens with short-acting insulin. Insulin Glargine is not recommended for intravenous administration. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia.
Initiation of Insulin Glargine therapy:
+
+- The recommended starting dose of Insulin Glargine in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. Short-acting, premeal insulin should be used to satisfy the remainder of the daily insulin requirements.
+- The recommended starting dose of Insulin Glargine in patients with type 2 diabetes who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted to the patient's needs.
+
+
Converting to Insulin Glargine from other insulin therapies: If changing from a treatment regimen with an intermediate-or long-acting insulin to a regimen with Insulin Glargine , the amount and timing of shorter-acting insulins and doses of any oral anti-diabetic drugs may need to be adjusted.
+
+- If transferring patients from once-daily NPH insulin to once-daily Insulin Glargine , the recommended initial Insulin Glargine dose is the same as the dose of NPH that is being discontinued.
+- If transferring patients from twice-daily NPH insulin to once-daily Insulin Glargine , the recommended initial Insulin Glargine dose is 80% of the total NPH dose that is being discontinued.
+
","Insulin Glargine should be injected subcutaneously once daily at any time of day, but at the same time everyday.
Cartridge:
+
+- Insert the Insulin Glargine cartridge into the pen correctly and equip the needle. Gently turn the pen upside down for 8-10 times until the insulin in the cartridge becomes uniformly mixed.
+- Adjust the dosage button to get correct dose. After removal of the needle cap and discharge air bubbles in the cartridge, it is ready to be injected. In order to avoid cross contamination, do not let the needle touch anything during the process of preparation.
+
+Vial:
+
+- Firstly, clean your hands. Shake or rotate the vial gently to mix the solution uniformly and check if the insulin has the normal appearance.
+- If using a new Insulin Glargine bottle then flip off the plastic protective cap and wipe the rubber stopper with an alcohol swab.
+- Draw air into your syringe equal to the amount of Insulin Glargine needed. Puncture the needle into the vial and inject the air.
+- Turn the bottle and syringe upside down. Withdraw correct dose of Insulin Glargine into the syringe. Before pulling out the needle, check if there are any bubbles remain in the syringe.
+- If so, put the syringe upright and tap the syringe to discharge the air bubbles.
+
+
Injection Site: Choose the area where skin is less tight, such as the upper arm, thigh, buttock and abdomen, etc. To avoid tissue damage, choose a site for each injection that is at least 1 cm from the previous injection site.
Injection Method: Cleanse the skin with alcohol where the injection is to be made. Put the needle in such a position as to form 45° angle with the skin. Puncture the needle into skin and inject insulin. Then pull the needle out and apply gentle pressure over the injected site for several seconds. Do not rub the injection site.
","A number of drugs affect glucose metabolism and may require dose adjustment.
The following substances may reduce the Insulin as well as Insulin glargine requirements: Oral anti-diabetic products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, propoxyphene, pentoxifylline, salicylates and sulfonamide antibiotics.
The following substances may increase the Insulin as well as Insulin glargine requirements: Thiazides, glucocorticoids, thyroid hormones, beta-sympathomimetics, growth hormone and danazol. Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin.
","Insulin glargine is contraindicated in patients with hypersensitivity to insulin glargine or any of its excipients.
","Side effects of Insulin glargine are hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, and rash.
","Pregnancy category C. Insulin glargine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is unknown whether insulin glargine is excreted in human milk. Because many drugs, including human insulin, are excreted in human milk, caution should be exercised when Insulin glargine is administered to a nursing woman. Lactating women may require adjustments in insulin dose & diet.
","Dose adjustment and monitoring: Blood glucose should be monitored in all patients treated with insulin. Insulin regimens should be modified cautiously and only under medical supervision.
Administration: Insulin glargine must not be diluted or mixed with any other insulin or solution. It should not be administered subcutaneously via an insulin pump or intravenously because severe hypoglycemia can occur.
Renal or hepatic impairment: Reduction in the Insulin glarginedose may require in these cases.
","Use in Renal/ Hepatic impairment: Reduction in the insulin glargine doses may be required in these cases.
","Insulin glargine overdose may result in hypoglycemia. Mild episodes of hypoglycemia can usually be treated with oral carbohydrates. Severe hypoglycemia may be treated with parenteral glucose or injections of glucagon. Adjustments in drug dosage, meal patterns, or exercise may be needed.
",,,"Store at 2° C to 8° C in a refrigerator. Do not freeze. In case of insulin for recent use need not to be refrigerated, try to keep it in a cool place and keep away from heat and light. The insulin in use can be kept under the room temperature for a month.
",13
+613,Insulin Detemir,insulin-detemir-613,https://medex.com.bd/attachments/Um9wZxqE8215vyDFUCA7342RIBuXND/insulin-detemir-prescribing-information,Long Acting Insulin,Type 1 DM,"Insulin Detemir is a long-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.
Important Limitations of Use: Not recommended for treating diabetic ketoacidosis. Use intravenous, rapid acting or short-acting insulin instead.
","Long Acting Insulin
","The primary activity of insulin detemir is the regulation of glucose metabolism. Insulins, including insulin detemir, exert their specific action through binding to insulin receptors. Receptor-bound insulin lowers blood glucose by facilitating cellular uptake of glucose into skeletal muscle and adipose tissue and by inhibiting the output of glucose from the liver. Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis, and enhances protein synthesis.
","Adult: In insulin-naive patients with type 2 DM who are not well controlled on oral antidiabetic drugs: Initial: 0.1 -0.2 unit/kg once daily in the evening or 10 unit 1-2 times/day, adjust subsequently based on glycaemic control.
In patients on basal insulin only: May substitute with insulin detemir on a unit-for-unit basis based on the current basal insulin dosage, adjust subsequently to achieve glycaemic targets.
",,"Possible absence of hypoglycaemic warning symptoms with beta-blockers. Increased blood sugar with thiazide diuretics, corticosteriods, chlorpromazine, tibolone, isoniazid, niacin, some calcium-channel blockers such as diltiazem or nifedipine, diazoxide, lithium and thyroid hormones. Increased risk of hypoglycemia with disopyramide, larges doses of aspirin, gatifloxacin, MAOIs, mebanazine, nandrolone, pegvisomant, testosterone. Decreased insulin resistance with octreotide and lanreotide. Increased risk of wt gain and peripheral oedema with pioglitazone, rosiglitazone. Decreased effect of sermorelin.
","Insulin Detemir is contraindicated in patients with hypersensitivity to Insulin Detemir or any of its excipients. Reactions have included anaphylaxis
","Hypoglycaemia, lipodystrophy, pruritus, rash, wt gain, sodium retention and oedema. Inj site reactions e.g. pain, itching, hives, swelling and inflammation. Influenza-like symptoms, Pallor, Palpitation, Tachycardia, Mental confusion, Weakness, Blurred vision, Itching, Hunger, Nausea.
","Pregnancy Category B. Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
Nursing Mothers: It is unknown whether Insulin detemir is excreted in human milk. Because many drugs, including human insulin, are excreted in human milk, use caution when administering Insulin detemir to a nursing woman. Women with diabetes who are lactating may require adjustments of their insulin doses.
","Renal or hepatic impairment. Regular monitoring of blood glucose and HbA1c. Continuous rotation of the inj site within a given area to reduce inj site reactions. Pregnancy, lactation
","Pediatric Use: The pharmacokinetics, safety and effectiveness of subcutaneous injections of Insulin Detemir have been established in pediatric patients (age 6 to 17 years) with type 1 diabetes. Insulin Detemir has not been studied in pediatric patients younger than 6 years of age with type 1 diabetes. Insulin Detemir has not been studied in pediatric patients with type 2 diabetes. The dose recommendation when converting to Insulin Detemir is the same as that described for adults. As in adults, the dosage of Insulin Detemir must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucose.
Geriatric Use: In controlled clinical trials comparing Insulin Detemir to NPH insulin or insulin glargine, 64 of 1624 patients (3.9%) in the type 1 diabetes trials and 309 of 1082 patients (28.6%) in the type 2 diabetes trials were≥65 years of age. A total of 52 (7 type 1 and 45 type 2) patients (1.9%) were ≥75 years of age. Nooverall differences in safety or effectiveness were observed between these patients and younger patients, but small sample sizes, particularly for patients ≥65 years of age in the type 1 diabetes trials and for patients ≥75 years of age in all trials limits conclusions. Greater sensitivity of some older individuals cannot be ruled out. In elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemia. Hypoglycemia may be difficult to recognize in the elderly.
","An excess of insulin relative to food intake, energy expenditure, or both may lead to severe and sometimes prolonged and life-threatening hypoglycemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid recurrence of hypoglycemia
",,,"Unused (unopened) Insulin Detemir should be stored in the refrigerator between 2° and 8°C. Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze. Do not use Insulin Detemir if it has been frozen. Unused (unopened) Insulin Detemir can be kept until the expiration date printed on the label if it is stored in a refrigerator. Keep unused Insulin Detemir in the carton so that it stays clean and protected from light.
If refrigeration is not possible, unused (unopened) Insulin Detemir can be kept unrefrigerated at room temperature, below 30°C as long as it is kept as cool as possible and away from direct heat and light. Unrefrigerated Insulin Detemir should be discarded 42 days after it is first kept out of the refrigerator, even if the FlexPen or vial still contains insulin.
",12
+618,Insulin Degludec + Insulin Aspart Premixed,insulin-degludec-insulin-aspart-premixed-618,https://medex.com.bd/attachments/go2zAKSl9pCaNW0IV7ZGKEtj3knw5Z/insulin-degludec-insulin-aspart-premixed-prescribing-information,Combination Insulin,Type 1 DM,"Insulin degludec (a long-acting human insulin analog) and insulin aspart (a rapid-acting human insulin analog) indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus
","Combination Insulin
","Insulin degludec and insulin aspart binds specifically to the human insulin receptor and results in the same pharmacological effects as human insulin.
The blood glucose-lowering effect of insulin is due to the facilitated uptake of glucose following the binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
","This is a soluble insulin product consisting of the basal insulin degludec and the rapid-acting prandial insulin aspart.
This is to be dosed in accordance with the individual patient's needs. Dose-adjustments are recommended to be primarily based on fasting plasma glucose measurements.
Patients with type 2 diabetes mellitus: The recommended total daily starting dose is 10 units with meal(s) followed by individual dosage adjustments.
Patients with type 1 diabetes mellitus: The recommended starting dose is 60-70% of the total daily insulin requirements. This is to be used once-daily at meal-time in combination.
","This can be administered once- or twice-daily with the main meal(s). When needed, the patient can change the time of administration as long as this insulin is dosed with the largest meal when taken once daily.
In patients with type 2 diabetes mellitus this insulin can be administered alone, in combination with oral anti-diabetic medicinal products, and in combination with bolus insulin.
In type 1 diabetes mellitus, this insulin is combined with short-/rapid-acting insulin at the remaining meals.
","There are no known drug interactions and none well documented.
","Hypersensitivity to the active substances or to any of the excipients.
","Hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain
","Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
There are no data on the presence of insulin degludec in human milk, the effects on the breastfed infant, or the effect on milk production. Insulin degludec is present in rat milk. One small published study reported that exogenous nsulin, including insulin aspart, was present in human milk. However, there is insufficient information to determine the effects of insulin aspart on the breastfed infant and no available information on the effects of insulin aspart on milk production.
","Hypoglycaemia: Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycaemia. Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. Concomitant illness, especially infections and fever, usually increases the patient's insulin requirement. Concomitant diseases in the kidney, liver or diseases affecting the adrenal, pituitary or thyroid gland may require changes in the insulin dose.
Hyperglycaemia: Administration of rapid-acting insulin is recommended in situations with severe hyperglycaemia. Inadequate dosing and/or discontinuation of treatment in patients requiring insulin may lead to hyperglycaemia and potentially to diabetic ketoacidosis. Furthermore, concomitant illness, especially infections, may lead to hyperglycaemia and thereby cause an increased insulin requirement.
Eye disorder: Intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Avoidance of accidental mix-ups: Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between this and other insulin products.
Older patients (> 65 years old): Insulin Degludec & Insulin Aspart Premixed can be used in older patients. Glucose-monitoring is to be intensified and the insulin dose adjusted on an individual basis.
Paediatric population: This Insulin has been administered to children and adolescents up to 18 years of age for the investigation of pharmacokinetic properties. Safety and efficacy have not been investigated in children and adolescents.
","Renal and hepatic impairment: This insulin can be used in renal and hepatic impaired patients. Glucose-monitoring is to be intensified and the insulin dose adjusted on an individual basis.
",,,,,11
+612,Insulin Degludec,insulin-degludec-612,https://medex.com.bd/attachments/dAasLobssLYx7ijYfqceMriLjoFUb0/insulin-degludec-prescribing-information,Long Acting Insulin,Type 1 DM,"Insulin Degludec is indicated for once-daily treatment of adults with diabetes mellitus to improve glycemic control. Insulin Degludec is not recommended for the treatment of diabetic ketoacidosis.
","Long Acting Insulin
","The primary activity of insulin, including Insulin Degludec, is regulation of glucose metabolism. Insulin and its analogues lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin also inhibits lipolysis and proteolysis, and enhances protein synthesis. Insulin Degludec forms multihexamers when injected into the subcutaneous tissue resulting in a subcutaneous insulin degludec depot. The protracted time action profile of Insulin Degludec is predominantly due to delayed absorption of insulin degludec from the subcutaneous tissue to the systemic circulation and to a lesser extent due to binding of insulin degludec to circulating albumin.
","Insulin Degludec is ultra long-acting basal insulin for once-daily at any time of the day, preferably at the same time every day.
Patients with type 2 diabetes mellitus: The recommended daily starting dose is 10 units followed by individual dosage adjustments.
Patients with type 1 diabetes mellitus: Insulin Degludec is to be used once-daily with meal-time insulin and requires subsequent individual dosage adjustments.
In patients with type 2 diabetes mellitus, Insulin Degludec can be administered alone or in any combination with oral anti-diabetic medicinal products, GLP-1 receptor agonists and bolus insulin. In type 1 diabetes mellitus, Insulin Degludec must be combined with short-/rapid-acting insulin to cover mealtime insulin requirements. On occasions when administration at the same time of the day is not possible, Insulin Degludec allows for flexibility in the timing of insulin administration. A minimum of 8 hours between injections should always be ensured. Patients who forget a dose, are advised to take it upon discovery and then resume their usual once-daily dosing schedule.
",,"Decreased hypoglycaemic effect with corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, phenothiazine derivatives, somatropin, sympathomimetic agents, thyroid hormones, oestrogens, progestins (e.g. in oral contraceptives), protease inhibitors and atypical antipsychotic (e.g. olanzapine and clozapine). Increased hypoglycaemic effect with oral antidiabetic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics. Decreased insulin resistance with octreotide and lanreotide. Increased risk of wt gain and peripheral oedema with pioglitazone, rosiglitazone. Decreased effect of sermorelin.
","Hypersensitivity to the active substance or to any of the excipients. Hypoglycaemia, Hyperglycaemia, Eye disorder.
","Nasopharyngitis, Severe hypoglycemic episode, Upper respiratory tract infection, Headache, Diarrhea, Sinusitis, Gastroenteritis, Injection site reactions, Peripheral edema
","Pregnant Women: There is no clinical experience from well-controlled studies with Insulin degludec in pregnant women. Animal reproduction studies have not revealed any differences between insulin degludec and human insulin regarding embryotoxicity and teratogenicity. Animal reproduction studies are not always predictive of human response; therefore, Insulin degludec should not be used during pregnancy unless the potential benefits to the mother justify the potential risks to the fetus
Nursing Women: There is no clinical experience from well controlled studies with Insulin degludec during breast-feeding. It is unknown whether insulin degludec is excreted in human milk. In rats, insulin degludec was secreted in milk; the concentration in milk was lower than in plasma.
","Insulin Degludecs must not be injected into a vein (intravenously) or a muscle (intramuscularly) and must not be used in infusion pumps.
There is no experience with Insulin Degludec in children and adolescents under 18 years of age.
","Geriatrics (≥ 65 years of age): No overall clinical differences in safety or effectiveness have been observed between elderly and adult patients.
Pediatrics (< 18 years of age): Insulin Degludec is not indicated for use in the pediatric population
",,,,,10
+2066,Insulin Aspart + Insulin Aspart Protamine,insulin-aspart-insulin-aspart-protamine-2066,,Rapid Acting Insulin,Type 2 DM,"This is a mixture of Insulin Aspart and Insulin Aspart Protamine indicated to improve glycemic control in patients with diabetes mellitus.
","Rapid Acting Insulin
","Insulin Aspart & Insulin Aspart Protamine is a human insulin analog suspension containing 30% Insulin Aspart & 70% Insulin Aspart Protamine used to lower blood glucose. Insulin Aspart is homologous with regular human insulin with the exception of a single substitution of the Amino Acid Proline by Aspartic Acid in position B28, and is produced by recombinant DNA technology utilizing Saccharomyces cerevisiae (baker's yeast). The primary activity of insulin, including Insulin Aspart is the regulation of glucose metabolism. Insulin, and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.
","This insulin is typically dosed twice daily (with each dose intended to cover 2 meals or a meal and a snack). Individualize and adjust the dosage based on the individual's metabolic needs, blood glucose monitoring results and glycemic control goal. Dosage adjustments may be needed with changes in physical activity, changes in meal patterns, changes in renal or hepatic function or during acute illness. Dosage adjustment may be needed when switching from another insulin to this insulin. Or, as directed by the registered physician. Blood glucose should be monitored in all patients treated with insulin. Insulin regimens should be modified cautiously and only under medical supervision.
Renal and Hepatic Impairment: Reduction the dose may require in these cases.
","Before injecting this Insulin:
+
+- Always check insulin labels before administration to make sure it is the right type of insulin.
+- Inject this subcutaneously in the abdominal region, buttocks, thigh, or upper arm.
+- Administer the dose within 15 minutes before meal initiation. For patients with type 2 diabetes, the dose may also be given after meal initiation.
+- Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy.
+- According to the instruction given with MyPen, insert the cartridge into the pen correctly & equip the needle.
+- Roll the cartridge between your palms 10 times- it is important that the cartridge is kept horizontal (level with the ground). Move the cartridge up and down 10 times so that the glass ball moves from one end of the cartridge to the other.
+- Repeat the rolling and moving procedures until the liquid appears uniformly white and cloudy. Do not use the cartridge if the resuspended insulin does not look uniformly white and cloudy.
+- This must be resuspended immediately before use. Resuspension is easier when the insulin has reached room temperatue.
+- Remove the needle cap, discharge air bubbles in the cartridge.
+- Adjust the dosage button to get correct dose & inject to the specific site.
+- Always use a new needle for each injection to prevent contamination.
+- Do not administer this insulin intravenously or use in insulin infusion pumps.
+- Do not use this insulin past the expiration date printed on the label.
+- Do not mix this insulin with any other insulins.
+- Complete the other stages of injection without delay.
+- Check that there are at least 12 units of insulin left in the cartridge to allow even resuspension. If there are less than 12 units left, use a new cartridge.
+
","A number of drugs affect glucose metabolism and may require dose adjustment. The following substances may reduce the insulin requirements: anti-diabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analog and sulfonamide antibiotics. The following substances may increase the insulin requirements: atypical antipsychotics, corticosteroids, danazol, diuretics, estrogen, glucagon, isoniazid, niacin, oral contraceptives, phenothiazine, progestogens, preotease inhibitors, somatropin, sympathomimetic agents and thyroid hormones. Beta-blockers, clonidine, lithium salts, alcohol and pentamidine may either potentiate or weaken the blood glucose lowering effect of insulin. Beta-blockers, clonidine, guanethidine and reserpine may blunt the signs and symptoms of hypoglycemia.
","Insulin Aspart is contraindicated during episodes of hypoglycemia, in patients with hypersensitivity to this drug or one of its excipients.
","Most common side effects are hypoglycemia, hypersensitivity and allergic reactions, hypokalemia, injection site reaction, lipodystrophy, pruritus and rash.
","Pregnancy category B. There are no available data in pregnant women to inform a drug-associated risk. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy. There are no data on the presence of Insulin in human milk, the effect on breastfed infants, or the effect on milk production.
",,,"Excess insulin administration may cause hypoglycemia and, particularly when given intravenously, hypokalemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. Hypokalemia must be corrected appropriately.
",,,"Storage when not in use: Store in a refrigerator (2°C to 8°C). Do not freeze. After removing from the refrigerator, it is recommended to allow to reach room temperature before resuspending the insulin for the first time use.
Storage during use: This is being used is not kept in the refrigerator. It can be kept at room temperature (below 30°C) for up to 4 weeks. Keep the cartridge in the outer carton in order to protect from light. This must be protected from excessive heat and light.
",11
+610,Insulin Aspart,insulin-aspart-610,https://medex.com.bd/attachments/35rTgao0NpnO64r19Snxg39aK9MeXN/insulin-aspart-prescribing-information,Rapid Acting Insulin,Type 1 DM,"Insulin Aspart is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.
","Rapid Acting Insulin
","The primary activity of Insulin Aspart is the regulation of glucose metabolism. Insulin Aspart bind to the insulin receptors on muscle and fat cells and lower blood glucose by facilitating the cellular uptake of glucose and simultaneously inhibiting the output of glucose from the liver.
","Dosage of Insulin Aspart is individual and determined by the physician in accordance with the needs of the patient. In patients with type 2 diabetes, Insulin Aspart can be given in mono therapy or in combination with oral antidiabetic drugs when the blood glucose is inadequately controlled with those oral antidiabetic drugs alone. For patients with type 2 diabetes, the recommended starting dose of Insulin Aspart is 6 IU at breakfast and 6 IU at dinner (evening meal). Insulin Aspart can also be initiated once daily with 12 IU at dinner (evening meal). When using Insulin Aspart once daily, it is generally recommended to move to twice-daily when reaching 30 units by splitting the dose into equal breakfast and dinner doses. If twice daily dosing with Insulin Aspart results in recurrent daytime hypoglycaemic episodes, the morning dose can be split into morning and lunchtime doses (thrice daily dosing).
The dose should not be increased if hypoglycemia occurred within three days. Dose adjustments can be made once a week until target HbA1c is reached. In patients with type 1 diabetes the individual insulin requirement is usually between 0.5 and 1.0 IU/kg/day. Insulin Aspart may fully or partially meet this requirement. When transferring a patient from biphasic human insulin to Insulin Aspart, start with the same dose and regimen. Then titrate according to individual needs (according to the titration guidelines in table above). Insulin Aspart can be used in elderly patients; however there is limited experience with the use of Insulin Aspart in combination with OADs in patients older than 75 years.
","Administer 5-10 min before meal
","A number of drugs affect glucose metabolism and may require dose adjustment. The following substances may reduce the Insulin as well as Insulin Aspart requirements: Oral anti-diabetic products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, propoxyphene, pentoxifylline, salicylates and sulfonamide antibiotics. The following substances may increase the Insulin as well as Insulin Aspart requirements: Thiazides, glucocorticoids, thyroid hormones, beta-sympathomimetics, growth hormone and danazol. Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood glucose lowering effect of insulin.
","Insulin Insulin Aspart is contraindicated-
+
+- during episodes of hypoglycemia
+- in patients with hypersensitivity to Insulin Aspart or one of its excipients
+
","Side effects of Insulin Aspart are hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus and rash.
","Pregnancy category B. There are no restrictions on treatment with Insulin Aspart during lactation. Insulin treatment of the nursing mother should not affect the baby. However, dosage may need to be adjusted.
","Dose adjustment and monitoring: Blood glucose should be monitored in all patients treated with insulin. Insulin regimens should be modified cautiously and only under medical supervision.
","Renal Impairment: Decreased dose may be necessary.
Hepatic Impairment: Decreased dose may be necessary.
","A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high doses relative to the patient’s requirement are administered. Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products. Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously. Glucose must also be given intravenously if the patient does not respond to glucagon within 10 to 15 minutes. Upon regaining consciousness administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
",,,"Store at 2°C to 8°C in a refrigerator. Do not freeze. Protect from light.
",13
+1869,Isotretinoin (Topical),isotretinoin-topical-1869,,Topical retinoid and related preparations,Acne vulgaris,"Isotretinoin topical gel is indicated for the treatment of mild to moderate inflammatory and non-inflammatory acne vulgaris.
","Topical retinoid and related preparations
","Isotretinoin produces its effects through altering progress through the cell cycle, cell differentiation, survival, and apoptosis. These actions reduce sebum production, preventing the blockage of pores, and growth of acne causing bacteria. Isotretinoin and 4-oxo-isotretinoin both significantly reduce the production of sebum. Isotretinoin has little to no affinity for retinol binding proteins (RBPs) and retinoic acid nuclear receptors (RARs). Tretinoin and 4-oxo-tretinion bind to the RAR-γ receptor, which is suspected to be part of the action of acne treatment by isotretinoin. Isotretinoin induces apoptosis in sebocytes, leading to a decrease in sebum production. Isotretinoin also reduces the formation of comedones by reducing hyperkeratinization through an unknown mechanism. Isotretinoin does not directly kill bacteria but it does reduce the size of sebum ducts and makes the microenvironment less hospitable to acne causing bacteria. It may also increase immune mechanisms and alter chemotaxis of monocytes to reduce inflammation.
","Apply Isotretinoin 0.05% gel cautiously over the affected area once or twice daily. Patients should be advised that 6-8 weeks of treatment may be required before a therapeutic effect is observed. The safety and efficacy of Isotretinoin have not been established in children since acne vulgaris rarely present in this age group. There are no specific recommendations for use in the elderly. Acne vulgaris does not present in the elderly.
",,"Concomitant topical medication should be used with caution during therapy with Isotretinoin. Particular caution should be exercised when using preparations containing a peeling agent (for example Benzoyl Peroxide) or abrasive cleansers.
","Isotretinoin 0.05% gel is contra-indicated in patients with known hypersensitivity to Isotretinoin.
","In normal use, Isotretinoin may cause stinging, burning or irritation; erythema and peeling at the site of application may occur. If undue irritation occurs, treatment should be interrupted temporarily and resumed once the reaction subsides. If irritation persists, treatment should be discontinued. Reactions will normally resolve on discontinuation of therapy.
","Pregnancy Category B. There is inadequate evidence of the safety of topically applied Isotretinoin in human pregnancy. Isotretinoin has been associated with teratogenicity in humans when administered systemically. Reproduction studies conducted in rabbits using Isotretinoin applied topically at up to 60 times the human dose have, however, revealed no harm to the foetus. The use of Isotretinoin should be avoided during pregnancy. Percutaneous absorption of Isotretinoin from Isotretinoin 0.05% gel is negligible. It is not known, however, whether Isotretinoin is excreted in human milk. Isotretinoin should not be used during lactation.
","Contact with the mouth, eyes and mucous membranes and with abraded or eczematous skin should be avoided. Care should be taken not to let the medication accumulate in skin fold areas and in the angles of the nose. Application to sensitive areas of skin, such as the neck, should be made with caution. Although Tretinoin has not been shown to initiate or promote carcinogenesis in humans, Tretinoin applied topically to albino hairless mice had resulted in a dose-related acceleration in ultraviolet-B radiation induced cutaneous tumours. The same author also observed the opposite effect in another study of low, non-irritating concentrations of Tretinoin. The significance of these findings as related to man is unknown; however, caution should be observed in patients with a personal or family history of cutaneous epithelioma. Exposure to sunlight of areas treated with Isotretinoin should be avoided or minimised. When exposure to strong sunlight cannot be avoided a sunscreen product and protective clothing should be used. Patients with sunburn should not use Isotretinoin due to the possibility of increased sensitivity to sunlight. The use of sunlamps should be avoided during treatment.
",,"Acute overdosage of Isotretinoin has not been reported to date. Accidental ingestion of Isotretinoin resulting in overdosage of Isotretinoin could be expected to induce symptoms of hypervitaminosis A. These include severe headaches, nausea or vomiting, drowsiness, irritability and pruritus.
",,,"Store in a cool and dry place, protected from light.
",11
+640,Isotretinoin (Oral),isotretinoin-oral-640,https://medex.com.bd/attachments/n7J8NnN2wxrkDdSdm60hl5rBpdbZta/isotretinoin-oral-prescribing-information,Oral retinoids for Acne,Acne vulgaris,"Isotretinoin is indicated in severe forms of acne (such as nodular or conglobate acne or acne at risk of permanent scarring) resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy.
","Oral retinoids for Acne
","Isotretinoin produces its effects through altering progress through the cell cycle, cell differentiation, survival, and apoptosis. These actions reduce sebum production, preventing the blockage of pores, and growth of acne causing bacteria. Isotretinoin and 4-oxo-isotretinoin both significantly reduce the production of sebum. Isotretinoin has little to no affinity for retinol binding proteins (RBPs) and retinoic acid nuclear receptors (RARs). Tretinoin and 4-oxo-tretinion bind to the RAR-γ receptor, which is suspected to be part of the action of acne treatment by isotretinoin. Isotretinoin induces apoptosis in sebocytes, leading to a decrease in sebum production. Isotretinoin also reduces the formation of comedones by reducing hyperkeratinization through an unknown mechanism. Isotretinoin does not directly kill bacteria but it does reduce the size of sebum ducts and makes the microenvironment less hospitable to acne causing bacteria. It may also increase immune mechanisms and alter chemotaxis of monocytes to reduce inflammation.
","The capsules should be taken with food once or twice daily. Isotretinoin should only be prescribed by or under the supervision of physicians with expertise in the use of systemic retinoids for the treatment of severe acne and a full understanding of the risks of Isotretinoin therapy and monitoring requirements.
Adults including adolescents and the elderly: Isotretinoin therapy should be started at a dose of 0.5 mg/kg daily. The therapeutic response to Isotretinoin and some of the adverse effects are dose-related and vary between patients. This necessitates individual dosage adjustment during therapy. For most patients, the dose ranges from 0.5-1.0 mg/kg per day. Long-term remission and relapse rates are more closely related to the total dose administered than to either duration of treatment or daily dose. It has been shown that no substantial additional benefit is to be expected beyond a cumulative treatment dose of 120-150 mg/kg. The duration of treatment will depend on the individual daily dose. A treatment course of 16-24 weeks is normally sufficient to achieve remission. In the majority of patients, complete clearing of the acne is obtained with a single treatment course. In the event of a definite relapse a further course of Isotretinoin therapy may be considered using the same daily dose and cumulative treatment dose. As further improvement of the acne can be observed up to 8 weeks after discontinuation of treatment, a further course of treatment should not be considered until at least this period has elapsed.
Patients with severe renal insufficiency: In patients with severe renal insufficiency treatment should be started at a lower dose (e.g. 10 mg/day). The dose should then be increased up to 1 mg/kg/day or until the patient is receiving the maximum tolerated dose.
Children: Isotretinoin is not indicated for the treatment of prepubertal acne and is not recommended in patients less than 12 years of age due to a lack of data on efficacy and safety.
Patients with intolerance: In patients who show severe intolerance to the recommended dose, treatment may be continued at a lower dose with the consequences of a longer therapy duration and a higher risk of relapse. In order to achieve the maximum possible efficacy in these patients the dose should normally be continued at the highest tolerated dose.
",,"Additive adverse effects with vit A or its derivatives. Decreased efficacy of microdosed progesterone (use 2 forms of contraception).Increased risk of local irritation with topical keratolytic or exfoliative anti-acne agents. Oxidising agents (e.g. benzoyl peroxide) may reduce the efficacy of topical isotretinoin.
","Isotretinoin is contraindicated in women who are pregnant or breastfeeding. Isotretinoin is contraindicated in women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met. Isotretinoin is also contraindicated in patients with hypersensitivity to Isotretinoin or to any of the excipients. Isotretinoin is also contraindicated in patients with hepatic insufficiency, with excessively elevated blood lipid values, with hypervitaminosis A, receiving concomitant treatment with tetracyclines.
This medicinal product is contraindicated in women of childbearing potential unless all of the following conditions of the Pregnancy Prevention Programme are met: She has severe acne (such as nodular or conglobate acne or acne at risk of permanent scarring) resistant to adequate courses of standard therapy with systemic anti-bacterials and topical therapy. She understands the teratogenic risk. She understands the need for rigorous follow-up, on a monthly basis. She understands and accepts the need for effective contraception, without interruption, 1 month before starting treatment, throughout the duration of treatment and 1 month after the end of treatment. At least one and preferably two complementary forms of contraception including a barrier method should be used. Even if she has amenorrhea she must follow all of the advice on effective contraception. She should be capable of complying with effective contraceptive measures. She is informed and understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy. She understands the need and accepts to undergo pregnancy testing before, during and 5 weeks after the end of treatment. She has acknowledged that she has understood the hazards and necessary precautions associated with the use of Isotretinoin. These conditions also concern women who are not currently sexually active unless the prescriber considers that there are compelling reasons to indicate that there is no risk of pregnancy. The prescriber must ensure that the patient complies with the conditions for pregnancy prevention as listed above, including confirmation that she has an adequate level of understanding. The patient has acknowledged the aforementioned conditions. The patient has used at least one and preferably two methods of effective contraception including a barrier method for at least 1 month prior to starting treatment and is continuing to use effective contraception throughout the treatment period and for at least 1 month after cessation of treatment. Negative pregnancy test results have been obtained before, during and 5 weeks after the end of treatment. The dates and results of pregnancy tests should be documented.
","Some of the side effects associated with the use of Isotretinoin are dose-related. The side effects are generally reversible after altering the dose or discontinuation of treatment, however some may persist after treatment has stopped. The following symptoms are the most commonly reported undesirable effects with Isotretinoin: dryness of the skin, dryness of the mucosae e.g. of the lips (cheilitis), the nasal mucosa (epistaxis) and the eyes (conjunctivitis).
The incidence of the adverse events was calculated from pooled clinical trial data involving 824 patients and from post-marketing data. Frequency categories are defined as Very common (³1/10), Common (³1/100 to <1/10), Uncommon (³1/1,000 to <1/100), Rare (³1/10,000 to <1/1,000), Very rare (³1/10,000 to <1/1,000) and not known (cannot be estimated from the available data. Infections: Very Rare: Gram positive (mucocutaneous) bacterial infection Blood and lymphatic system disorders: Very common: Anaemia, red blood cell sedimentation rate increased, thrombocytopenia, thrombocytosis; Common: Neutropenia; Very Rare: Lymphadenopathy Immune system disorders: Rare: Allergic skin reaction, anaphylactic reactions, hypersensitivity Metabolism and nutrition disorders: Very Rare: Diabetes mellitus, hyperuricaemia Psychiatric disorders: Rare: Depression, depression aggravated, aggressive tendencies, anxiety, mood alterations. Very Rare: Abnormal behaviour, psychotic disorder, suicidal ideation suicide attempt, suicide Nervous system disorders: Common: Headache; Very Rare: Benign intracranial hypertension, convulsions, drowsiness, dizziness Eye disorders: Very Common: Blepharitis, conjunctivitis, dry eye, eye irritation; Very Rare: Blurred vision, cataract, colour blindness (colour vision deficiencies), contact lens intolerance, corneal opacity, decreased night vision, keratitis, papilloedema (as sign of benign intracranial hypertension), photophobia, visual disturbances. Ear and labyrinth disorders: Very Rare: Hearing impaired Vascular disorders: Very Rare: Vasculitis (for example Wegener's granulomatosis, allergic vasculitis) Respiratory, thoracic and mediastinal disorders: Common: Epistaxis, nasal dryness, nasopharyngitis, Very Rare: Bronchospasm (particularly in patients with asthma), hoarseness Gastrointestinal disorders: Very Rare: Colitis, ileitis, dry throat, gastrointestinal haemorrhage, haemorrhagic diarrhoea and inflammatory bowel disease, nausea, pancreatitis Hepatobiliary disorders: Very Common: Transaminase increased; Very rare: Hepatitis Skin and subcutaneous tissues disorders: Very Common: Pruritus, rash erythematous, dermatitis, cheilitis, dry skin, localised exfoliation, skin fragility (risk of frictional trauma), Rare: Alopecia, Very Rare: Acne fulminans, acne aggravated (acne flare), erythema (facial), exanthema, hair disorders, hirsutism, nail dystrophy, paronychia, photosensitivity reaction, pyogenic granuloma, skin hyperpigmentation, sweating increased. Musculo-skeletal and connective tissue disorders: Very Common: Arthralgia, myalgia, back pain (particularly in children and adolescent patients), Very Rare: Arthritis, calcinosis (calcification of ligaments and tendons), epiphyses premature fusion, exostosis, (hyperostosis), reduced bone density, tendonitis. Renal and urinary disorders: Very Rare: Glomerulonephritis. General disorders and administration site conditions: Very Rare: Granulation tissue (increased formation of), malaise. Overdose Isotretinoin is a derivative of vitamin A. Although the acute toxicity of Isotretinoin is low, signs of hypervitaminosis A could appear in cases of accidental overdose. Manifestations of acute vitamin A toxicity include severe headache, nausea or vomiting, drowsiness, irritability and pruritus. Signs and symptoms of accidental or deliberate overdosage with Isotretinoin would probably be similar. These symptoms would be expected to be reversible and to subside without the need for treatment. Pharmaceutical precautions Store in a cool and dry place protected from light.
","Pregnancy is an absolute contraindication to treatment with Isotretinoin. If pregnancy does occur in spite of these precautions during treatment with Isotretinoin or in the month following, there is a great risk of very severe and serious malformation of the foetus. The foetal malformations associated with exposure to Isotretinoin include central nervous system abnormalities (hydrocephalus, cerebellar malformation/abnormalities, microcephaly), facial dysmorphia, cleft palate, external ear abnormalities (absence of external ear, small or absent external auditory canals), eye abnormalities (microphthalmia), cardiovascular abnormalities (conotruncal malformations such as tetralogy of Fallot, transposition of great vessels, septal defects), thymus gland abnormality and parathyroid gland abnormalities. There is also an increased incidence of spontaneous abortion. If pregnancy occurs in a woman treated with Isotretinoin, treatment must be stopped and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice. Isotretinoin is highly lipophilic, therefore the passage of Isotretinoin into human milk is very likely. Due to the potential for adverse effects in the child exposed via mothers’ milk, the use of Isotretinoin is contraindicated in nursing mothers.
","Contraception: Female patients must be provided with comprehensive information on pregnancy prevention and should be referred for contraceptive advice if they are not using effective contraception. As a minimum requirement, female patients at potential risk of pregnancy must use at least one effective method of contraception. Preferably the patient should use two complementary forms of contraception including a barrier method. Contraception should be continued for at least 1 month after stopping treatment with Isotretinoin, even in patients with amenorrhea.
Pregnancy testing: According to local practice, medically supervised pregnancy tests with a minimum sensitivity of 25mIU/mL are recommended to be performed in the first 3 days of the menstrual cycle, as follows.
Prior to starting therapy: In order to exclude the possibility of pregnancy prior to starting contraception, it is recommended that an initial medically supervised pregnancy test should be performed and its date and result recorded. In patients without regular menses, the timing of this pregnancy test should reflect the sexual activity of the patient and should be undertaken approximately 3 weeks after the patient last had unprotected sexual intercourse. The prescriber should educate the patient about contraception. A medically supervised pregnancy test should also be performed during the consultation when Isotretinoin is prescribed or in the 3 days prior to the visit to the prescriber, and should have been delayed until the patient had been using effective contraception for at least 1 month. This test should ensure the patient is not pregnant when she starts treatment with Isotretinoin.
Follow-up visits: Follow-up visits should be arranged at 28 day intervals. The need for repeated medically supervised pregnancy tests every month should be determined according to local practice including consideration of the patient’s sexual activity and recent menstrual history (abnormal menses, missed periods or amenorrhea). Where indicated, follow-up pregnancy tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the prescriber.
End of treatment: Five weeks after stopping treatment, women should undergo a final pregnancy test to exclude pregnancy.
Prescribing and dispensing restrictions: Prescriptions of Isotretinoin for women of childbearing potential should be limited to 30 days of treatment and continuation of treatment requires a new prescription. Ideally, pregnancy testing, issuing a prescription and dispensing of Isotretinoin should occur on the same day. Dispensing of Isotretinoin should occur within a maximum of 7 days of the prescription.
Male patients: The available data suggest that the level of maternal exposure from the semen of the patients receiving Isotretinoin, is not of a sufficient magnitude to be associated with the teratogenic effects of Isotretinoin. Male patients should be reminded that they must not share their medication with anyone, particularly not females.
Additional precautions: Patients should be instructed never to give this medicinal product to another person, and to return any unused capsules to their pharmacist at the end of treatment. Patients should not donate blood during therapy and for 1 month following discontinuation of Isotretinoin because of the potential risk to the foetus of a pregnant transfusion recipient.
Psychiatric disorders: Depression, depression aggravated, anxiety, aggressive tendencies, mood alterations, psychotic symptoms, and very rarely, suicidal ideation, suicide attempts and suicide have been reported in patients treated with Isotretinoin. Particular care needs to be taken in patients with a history of depression and all patients should be monitored for signs of depression and referred for appropriate treatment if necessary. However, discontinuation of Isotretinoin may be insufficient to alleviate symptoms and therefore further psychiatric or psychological evaluation may be necessary.
Skin and subcutaneous tissues disorders: Acute exacerbation of acne is occasionally seen during the initial period but this subsides with continued treatment, usually within 7-10 days, and usually does not require dose adjustment. Exposure to intense sunlight or to UV rays should be avoided. Where necessary a sun-protection product with a high protection factor of at least SPF 15 should be used. Aggressive chemical dermabrasion and cutaneous laser treatment should be avoided in patients on Isotretinoin for a period of 5-6 months after the end of the treatment because of the risk of hypertrophic scarring in atypical areas and more rarely post inflammatory hyper or hypopigmentation in treated areas. Wax depilation should be avoided in patients on Isotretinoin for at least a period of 6 months after treatment because of the risk of epidermal stripping. Concurrent administration of Isotretinoin with topical keratolytic or exfoliative anti-acne agents should be avoided as local irritation may increase. Patients should be advised to use a skin moisturising ointment or cream and a lip balm from the start of treatment as Isotretinoin is likely to cause dryness of the skin and lips. There have been post-marketing reports of severe skin reactions (e.g. erythema multiforme (EM), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)) associated with Isotretinoin use. As these events may be difficult to distinguish from other skin reactions that may occur, patients should be advised of the signs and symptoms and monitored closely for severe skin reactions. If a severe skin reaction is suspected, Isotretinoin treatment should be discontinued. Allergic reactions: Anaphylactic reactions have been rarely reported, in some cases after previous topical exposure to retinoids. Allergic cutaneous reactions are reported infrequently. Serious cases of allergic vasculitis, often with purpura (bruises and red patches) of the extremities and extracutaneous involvement have been reported. Severe allergic reactions necessitate interruption of therapy and careful monitoring.
Eye disorders: Dry eyes, corneal opacities, decreased night vision and keratitis usually resolve after discontinuation of therapy. Dry eyes can be helped by the application of a lubricating eye ointment or by the application of tear replacement therapy. Intolerance to contact lenses may occur which may necessitate the patient to wear glasses during treatment. Decreased night vision has also been reported and the onset in some patients was sudden. Withdrawal of Isotretinoin may be necessary.
Musculo-skeletal and connective tissue disorders: Myalgia, arthralgia and increased serum creatine phosphokinase values have been reported in patients receiving Isotretinoin, particularly in those undertaking vigorous physical activity. Bone changes including premature epiphyseal closure, hyperostosis, and calcification of tendons and ligaments have occurred after several years of administration at very high doses for treating disorders of keratinisation. The dose levels, duration of treatment and total cumulative dose in these patients generally far exceeded those recommended for the treatment of acne.
Benign intracranial hypertension: Cases of benign intracranial hypertension have been reported, some of which involved concomitant use of tetracyclines. Signs and symptoms of benign intracranial hypertension include headache, nausea and vomiting, visual disturbances and papilloedema. Patients who develop benign intracranial hypertension should discontinue Isotretinoin immediately.
Hepatobiliary disorders: Liver enzymes should be checked before treatment, 1 month after the start of treatment, and subsequently at 3 monthly intervals unless more frequent monitoring is clinically indicated. Transient and reversible increases in liver transaminases have been reported. In many cases these changes have been within the normal range and values have returned to baseline levels during treatment. However, in the event of persistent clinically relevant elevation of transaminase levels, reduction of the dose or discontinuation of treatment should be considered.
Renal insufficiency: Renal insufficiency and renal failure do not affect the pharmacokinetics of Isotretinoin. Therefore, Isotretinoin can be given to patients with renal insufficiency. However, it is recommended that patients are started on a low dose and titrated up to the maximum tolerated dose.
Lipid Metabolism: Serum lipids (fasting values) should be checked before treatment, 1 month after the start of treatment, and subsequently at 3 monthly intervals unless more frequent monitoring is clinically indicated. Elevated serum lipid values usually return to normal on reduction of the dose or discontinuation of treatment and may also respond to dietary measures. Isotretinoin has been associated with an increase in plasma triglyceride levels. Isotretinoin should be discontinued if hypertriglyceridaemia cannot be controlled at an acceptable level or if symptoms of pancreatitis occur. Levels in excess of 800mg/dL or 9mmol/L are sometimes associated with acute pancreatitis, which may be fatal.
Gastrointestinal disorders: Isotretinoin has been associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders. Patients experiencing severe (hemorrhagic) diarrhoea should discontinue Isotretinoin immediately.
High Risk Patients: In patients with diabetes, obesity, alcoholism or a lipid metabolism disorder undergoing treatment with Isotretinoin, more frequent checks of serum values for lipids and/or blood glucose may be necessary. Elevated fasting blood sugars have been reported, and new cases of diabetes have been diagnosed during Isotretinoin therapy.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+639,Isosorbide Mononitrate,isosorbide-mononitrate-639,https://medex.com.bd/attachments/GZKMaAdUm9qrshE2Afu0HleJ4oq44Z/isosorbide-mononitrate-20-mg-tablet-prescribing-information,Nitrates: Coronary vasodilators,Ischaemic heart disease,"Isosorbide Mononitrate is indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
","Nitrates: Coronary vasodilators
","Isosorbide mononitrate is the major active metabolite of isosorbide dinitrate (ISDN), and most of the clinical activity of the dinitrate is attributable to the mononitrate. The principal pharmacological action of isosorbide mononitrate is relaxation of vascular smooth muscle and consequent dilatation of peripheral arteries and veins, especially the latter. Dilation of the veins promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure and pulmonary capillary wedge pressure (preload). Arteriolar relaxation reduces systemic vascular resistance, systolic arterial pressure, and mean arterial pressure (afterload). Dilatation of the coronary arteries also occurs. The relative importance of preload reduction, afterload reduction and coronary dilatation remains undefined.
","Tablet: The usual oral dose is 1 tablet (20 mg) 2 times daily, first dose in the morning and another 7 hours apart. Although maintenance doses ranging from 20 mg to 120 mg (1-6 tablets), a dose of 10 mg (1/2 tablet) is suitable when lower dosage is used at the starting of treatment or as directed by a registered physician.
Sustained Release Capsule: The usual oral dose is 1 capsule (50 mg) daily or as directed by the registered physician.
",,"
+- Concomitant use of Isosorbide Mononitrate with phosphodiesterase inhibitors in any form is contraindicated.
+- Concomitant use of Isosorbide Mononitrate with riociguat, a soluble guanylate cyclase stimulator, is contraindicated.
+- The vasodilating effects of isosorbide mononitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.
+- Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary.
+
","Isosorbide mononitrate is contraindicated in patients who are allergic to it. Do not use Isosorbide Mononitrate in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia. Do not use Isosorbide Mononitrate in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.
","Headache, feelings of dizziness, hypotension may occur sometimes.
","Pregnancy Category B: Reproduction studies performed in rats and rabbits at doses of up to 540 and 810 mg/kg/day, respectively, have revealed no evidence of harm to the fetus due to isosorbide mononitrate. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Isosorbide Mononitrate should be used during pregnancy only if clearly needed.
Nursing Mothers: It is not known whether isosorbide mononitrate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when isosorbide mononitrate is administered to a nursing woman.
","Severe hypotension, particularly with upright posture, may occur with even small doses of isosorbide mononitrate. This drug should therefore be used with caution in patients who may be volume depleted or who, for whatever reason, are already hypotensive. Hypotension induced by isosorbide mononitrate may be accompanied by paradoxical bradycardia and increased angina pectoris.
Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy. In industrial workers who have had long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance clearly occurs. Chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers, demonstrating the existence of true physical dependence. The importance of these observations to the routine, clinical use of oral isosorbide mononitrate is not known.
Patients should be told that the antianginal efficacy of Isosorbide Mononitrate tablets can be maintained by carefully following the prescribed schedule of dosing (two doses taken seven hours apart). For most patients, this can be accomplished by taking the first dose on awakening and the second dose 7 hours later.
As with other nitrates, daily headaches sometimes accompany treatment with isosorbide mononitrate. In patients who get these headaches, the headaches are a marker of the activity of the drug. Patients should resist the temptation to avoid headaches by altering the schedule of their treatment with isosorbide mononitrate, since loss of headache may be associated with simultaneous loss of antianginal efficacy. Aspirin and/or acetaminophen, on the other hand, often successfully relieve isosorbide mononitrate-induced headaches with no deleterious effect on isosorbide mononitrate’s antianginal efficacy.
Treatment with isosorbide mononitrate may be associated with light-headedness on standing, especially just after rising from a recumbent or seated position. This effect may be more frequent in patients who have also consumed alcohol.
",,"Symptoms: Most common symptoms are hypotension, throbbing headache, tachycardia, and flushing. Methemoglobinemia may occur with massive doses.
Treatment: Treatment consists of placing patients in recumbent position and administering fluids; alpha-adrenergic vasopressors may be required. Methemoglobinemia should be treated with methyline blue at a dose of 1-2 mg/kg IV slowly.
",,,"Store at 20°-30°C.
",11
+1306,Isopropyl Alcohol + Hydrogen Peroxide + Glycerol,isopropyl-alcohol-hydrogen-peroxide-glycerol-1306,,Bleaching and Disinfectants,Preoperative hand disinfection,"This hand sanitizer is generally used to decrease infectious agents on the hands and is the most commonly used disinfectant in pharmaceutical industries. The important thing is that only 70% solution of isopropyl alcohol acts as a disinfectant killing all surface microorganisms. It is used to disinfect hands and equipment surface in pharmaceuticals.
","Bleaching and Disinfectants
","Isopropyl Alcohol is an isomer of propyl alcohol with antibacterial properties. Although the exact mechanism of isopropanol's disinfecting action is not known, it might kill cells by denaturing cell proteins and DNA, interfering with cellular metabolism, and dissolving cell lipo-protein membranes. Isopropanol is used in soaps and lotions as an antiseptic. 70 % isopropyl alcohol solution kills microorganisms by dissolving plasma membrane of the cell wall.
Glycerol: used as humectant, but other emollients may be used for skin care, provided that they are cheap, widely available and miscible in water and alcohol and do not add to toxicity, or promote allergy.
Hydrogen peroxide: used to inactivate contaminating bacterial spores in the solution and is not an active substance for hand antisepsis.
","Alcohol-based hand sanitizer is more convenient compared to hand washing with soap and water in most situations in the healthcare setting. It is generally more effective at killing microorganisms and better tolerated than soap and water. Alcohol-based hand sanitizer is recommended only if soap and water are not available. Using guideline is given bellow-
+
+- Apply product to the palm of one hand.
+- Rub hands together.
+- Rub the product over all surfaces of hands and fingers until hands are dry.
+
",,,"Isopropyl Alcohol is contraindicated in patients with known Hypersensitivity.
","Inhaling large amounts of isopropyl alcohol can cause nausea, vomiting, irritation of the nose and mucous membranes, throat irritations, and even difficulty with breathing as coughing can occur making it difficult for you to catch your breath. Isopropyl alcohol may cause burning, stinging, or a cold feeling where the medicine is applied.
",,"Isopropyl Alcohol is highly flammable in the presence of heat, sparks, or an open flame. When handling isopropyl alcohol in a work environment (to best to avoid any contact with skin) protective clothing should be always be worn, including safety gloves and goggles. Isopropyl alcohol should be kept away from heat, sparks, flames and other sources of ignition, as well as strong oxidizers, acetaldehyde, chlorine, ethylene oxide, acids, and isocyanates. A flammable safety cabinet is the best storage option.
",,,,,"Isopropyl alcohol should be stored in a tightly closed container in a cool & dry place, protected from light, well-ventilated area. Due to the chemical's extreme flammability, it must be kept away from all possible ignition sources, including heat, sparks, and flames. Keep out of reach of children.
",8
+1823,Isopropyl alcohol,isopropyl-alcohol-1823,,Other antibacterial preparation,Antiseptic skin cleanser,"For the disinfection of clean and intact skin. For pre-operative surgical hand disinfection, hand disinfection on the ward prior to aseptic procedures or after handling contaminated materials. For disinfection of the patients' skin prior to surgery or other invasive procedures
","Other antibacterial preparation
","Isopropyl Alcohol is an isomer of propyl alcohol with antibacterial properties. Although the exact mechanism of isopropanol's disinfecting action is not known, it might kill cells by denaturing cell proteins and DNA, interfering with cellular metabolism, and dissolving cell lipo-protein membranes. Isopropanol is used in soaps and lotions as an antiseptic. 70 % isopropyl alcohol solution kills microorganisms by dissolving plasma membrane of the cell wall.
","Squeeze thumbnail size amount in your palm then briskly rub hands together until dry. Use as often as required.
","To completely remove germs from hands wash your hand with this Anti-Germ Hand Wash for 20 seconds using the below WHO recommended 7 steps:
+
+- Step 1: Wet Hands. Wet your hands and apply enough liquid soap to create a good lather.
+- Step 2: Rub Palms Together.
+- Step 3: Rub the Back of Hands.
+- Step 4: Interlink Your Fingers.
+- Step 5: Cup Your Fingers.
+- Step 6: Clean the Thumbs.
+- Step 7: Rub Palms with Your Fingers.
+
",,,,,"
+- Highly Flammable. Keep away from fire or flame
+- For external use only
+- Avoid eyes. In case of contact with eye, flush with water
+- Discontinue use if skin irritation occurs
+- Keep out of reach of children
+
",,,,,"Isopropyl alcohol should be stored in a tightly closed container in a cool & dry place, protected from light, well-ventilated area. Due to the chemical's extreme flammability, it must be kept away from all possible ignition sources, including heat, sparks, and flames. Keep out of reach of children.
",7
+637,Isopropamide + Trifluoperazine,isopropamide-trifluoperazine-637,,Phenothiazine related drugs,Tension,"This preparation may be employed to advantage in the treatment of a wide range of gastrointestinal disorders, including such conditions as peptic ulcer, gastritis, hyperchlorhydria, functional diarrhea, irritable or spastic colon, pyloroduodenal irritability, pylorospasm, acute nonspecific gastroenteritis ... Read more
This preparation may be employed to advantage in the treatment of a wide range of gastrointestinal disorders, including such conditions as peptic ulcer, gastritis, hyperchlorhydria, functional diarrhea, irritable or spastic colon, pyloroduodenal irritability, pylorospasm, acute nonspecific gastroenteritis, biliary dyskinesia and chronic cholelithiasis, duodenitis, gastrointestinal spasm; it may also be used to treat genitourinary spasm. This preparation is particularly indicated where anxiety, tension, worry, or other emotional factors are thought to be wholly or partially responsible for the digestive dysfunction
","Anticholinergics (antimuscarinics)/ Anti-spasmodics, Phenothiazine related drugs
","Trifluoperazine inhibits dopamine D2 receptors in the brain. It has weak anticholinergic and sedative effects but strong extrapyramidal and antiemetic effects. It controls severely disturbed, agitated or violent behaviour but may also be used for nonpsychotic anxiety.
","Since both components of this preparation are inherently long-acting, a single tablet twice daily (every 12 hours) can provide continuous 24-hour control of symptoms of ulcer and other gastrointestinal disorders.
In addition to the convenience of twice-daily dosage, this tablet can provide significant therapeutic advantages: continuous reduction of gastric secretion; continuous inhibition of spasm and motility; continuous relief of anxiety and tension; continuous control of nausea and vomiting.
",,"Increased CNS depression with CNS depressants such as opiates or other analgesics, barbiturates or other sedatives, general anaesthetics, or alcohol. Increased risk of side effects with drugs with antimuscarinic properties e.g. TCA, antiparkinsonian drugs. Antagonised effects of dopaminergic drugs such as levodopa. Increased risk of hypotension with antihypertensives, trazodone. Reverses antihypertensive effect of guanethidine. Increased risk of severe extrapyramidal side-effects or severe neurotoxicity with lithium. Possible decrease in absorption with antacids.
","Because of the antiemetic action of the trifluoperazine component, this should not be used where nausea and vomiting are believed to be evidence of intestinal obstruction or brain tumor.
","The usual anticholinergic side effects are dry mouth, blurred vision, urinary hesitancy and retention, and constipation–have been encountered with this tablet.
","Use during pregnancy should be restricted to those cases where the potential benefit to the mother outweighs the potential risk to the fetus. Adequate human data on use during lactation and adequate animal reproduction studies are not available.
","Use with caution in elderly patients, in patients with cardiac impairment, hyperthyroidism, or hiatal hernia associated with reflux esophagitis (anticholinergic drugs may aggravate this condition).
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+634,Isoniazid,isoniazid-634,https://medex.com.bd/attachments/zg4APokTmR0R1MtmQopN1UL4BbW2Vf/isoniazid-prescribing-information,Anti-Tubercular Chemotherapeutics,Tuberculosis,"Isoniazid is indicated for the treatment of all forms of tuberculosis in which organisms are susceptible.
","Anti-Tubercular Chemotherapeutics
","Isoniazid inhibits the synthesis of mycoloic acids in susceptible bacteria which results in loss of acid-fastness and disruption of bacterial cell wall. At therapeutic levels, it is bacteriocidal against actively growing intracellular and extracellular Mycobacterium tuberculosis organisms.
","Adult:
+
+- Active tuberculosis: 5 mg/kg/day. Max: 300 mg/day or 15 mg/kg up to 900 mg/day, 2 or 3 times wkly.
+- Latent tuberculosis: 300 mg/day for 6 mth. Nontuberculous mycobacterial infections 5 mg/kg/day for at least 12 mth of culture-negative sputum. Max: 300 mg/day.
+
+
Child:
10-15 mg/kg/day, max 300 mg/day q 12-24 hourly
With directly observed biweekly therapy, dosage is 20-30 mg/kg, max 900 mg/dose twice weekly
",,"Inhibit the hepatic metabolism of antiepileptics (e.g. carbamazepine, ethosuximide, primidone, phenytoin), benzodiazepines (e.g. diazepam, triazolam), chlorzoxazone, theophylline, disulfiram, sometimes leading to increased toxicity. Increased metabolism of enflurane, resulting in potentially nephrotoxic levels of fluoride. Increased concentrations and enhanced effects or toxicity of clofazimine, cycloserine and warfarin. Reduced absorption with Al-containing antacids. Increased risk of peripheral neuropathy with zalcitabine and stavudine.
","Acute liver disease or history of hepatic damage during INH therapy; hypersensitivity.
","Peripheral neuropathy (dose-related incidence, 10-20% incidence with 10 mg/kg/d), Loss of appetite, Nausea, Vomiting, Stomach pain, Weakness 1-10%, Dizziness, Slurred speech, Lethargy, Progressive liver damage (increases with age; 2.3% in pts > 50 yo), Hyperreflexia, Agranulocytosis, Anemia, Megaloblastic anemia, Thrombocytopenia, Systemic lupus erythematosus, Seizure
","Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Lactation: distributed into milk but safe for nursing infants
","Renal or hepatic impairment; convulsive disorders; history of psychosis; patients at risk of neuropathy or pyridoxine deficiency eg, diabetic, alcoholic, malnourished, uraemic, infected with HIV. Careful monitoring of hepatic function is necessary for black and hispanic women. Check hepatic function before and during treatment. Pregnancy and lactation.
",,,,,,9
+633,Isoflurane,isoflurane-633,https://medex.com.bd/attachments/1Qi08sQNBSpzUVasilY3U2m1RdtjiA/isoflurane-prescribing-information,General (Inhalation) anesthetics,Obstetric analgesia,"Isoflurane may be used for induction and maintenance of general anesthesia. Adequate data have not been developed to establish its application in obstetrical anesthesia.
","General (Inhalation) anesthetics
","Isoflurane may be used for induction and maintenance of general anesthesia. Adequate data have not been developed to establish its application in obstetrical anesthesia.
Induction of and recovery from Isoflurane anesthesia are rapid. Isoflurane has a mild pungency, which limits the rate of induction, although excessive salivation or tracheobronchial secretions do not appear to be stimulated. Pharyngeal and laryngeal reflexes are readily obtunded. The level of anesthesia may be changed rapidly with Isoflurane. Isoflurane is a profound respiratory depressant. Respiration must be monitored closely and supported when necessary. As anesthetic dose is increased, tidal volume decreases and respiratory rate is unchanged. This depression is partially reversed by surgical stimulation, even at deeper levels of anesthesia. Isoflurane evokes a sigh response reminiscent of that seen with diethyl ether and enflurane, although the frequency is less than with enflurane.
Blood pressure decreases with induction of anesthesia but returns toward normal with surgical stimulation. Progressive increases in depth of anesthesia produce corresponding decreases in blood pressure. Nitrous oxide diminishes the inspiratory concentration of Isoflurane required to reach a desired level of anesthesia and may reduce the arterial hypotension seen with Isoflurane alone. Heart rhythm is remarkably stable. With controlled ventilation and normal PaCO2, cardiac output is maintained despite increasing depth of anesthesia, primarily through an increase in heart rate, which compensates for a reduction in stroke volume. The hypercapnia, which attends spontaneous ventilation during Isoflurane anesthesia further increases heart rate and raises cardiac output above awake levels. Isoflurane does not sensitize the myocardium to exogenously administered epinephrine in the dog. Limited data indicate that subcutaneous injection of 0.25 mg of epinephrine (50 mL of 1:200,000 solution) does not produce an increase in ventricular arrhythmias in patients anesthetized with Isoflurane.
Muscle relaxation is often adequate for intra-abdominal operations at normal levels of anesthesia. Complete muscle paralysis can be attained with small doses of muscle relaxants. All commonly used muscle relaxants are markedly potentiated with Isoflurane, the effect being most profound with the nondepolarizing type. Neostigmine reverses the effect of nondepolarizing muscle relaxants in the presence of Isoflurane. All commonly used muscle relaxants are compatible with Isoflurane.
Isoflurane can produce coronary vasodilation at the arteriolar level in selected animal models; the drug is probably also a coronary dilator in humans. Isoflurane, like some other coronary arteriolar dilators, has been shown to divert blood from collateral dependent myocardium to normally perfused areas in an animal model (“coronary steal”). Clinical studies to date evaluating myocardial ischemia, infarction and death as outcome parameters have not established that the coronary arteriolar dilation property of Isoflurane is associated with coronary steal or myocardial ischemia in patients with coronary artery disease
","Premedication: Premedication should be selected according to the need of the individual patient, taking into account that secretions are weakly stimulated by Isoflurane, and the heart rate tends to be increased. The use of anticholinergic drugs is a matter of choice.
Inspired Concentration: The concentration of Isoflurane being delivered from a vaporizer during anesthesia should be known. This may be accomplished by using:
Vaporizers calibrated specifically for Isoflurane;
Vaporizers from which delivered flows can be calculated, such as vaporizers delivering a saturated vapor, which is then diluted. The delivered concentration from such a vaporizer may be calculated using the formula:
% Isoflurane = 100 PvFv/FT (PA - PV)Where:
+
+- PA= Pressure of atmosphere
+- PV= Vapor pressure of Isoflurane
+- FV= Flow of gas through vaporizer (mL/min)
+- FT= Total gas flow (mL/min)
+
+Isoflurane contains no stabilizer. Nothing in the agent alters calibration or operation of these vaporizers.
Induction: Induction with Isoflurane in oxygen or in combination with oxygen-nitrous oxide mixtures may produce coughing, breath holding, or laryngospasm. These difficulties may be avoided by the use of a hypnotic dose of an ultra-short-acting barbiturate. Inspired concentrations of 1.5 to 3.0% Isoflurane usually produce surgical anesthesia in 7 to 10 minutes.
Maintenance: Surgical levels of anesthesia may be sustained with a 1.0 to 2.5% concentration when nitrous oxide is used concomitantly. An additional 0.5 to 1.0% may be required when Isoflurane is given using oxygen alone. If added relaxation is required, supplemental doses of muscle relaxants may be used.
The level of blood pressure during maintenance is an inverse function of Isoflurane concentration in the absence of other complicating problems. Excessive decreases may be due to depth of anesthesia and in such instances may be corrected by lightening anesthesia.
",,"Enhances effects of neuromuscular blockers. May sensitise the myocardium to adrenaline and other sympathomimetics. Enhances hypotensive effects of ACE inhibitors, TCAs, MAOIs, antihypertensives, antipsychotics or beta-blockers. May have synergistic effects with CNS depressants.
","Known or suspected susceptibility to malignant hyperthermia. Porphyria.
","Nausea, Vomiting, Shivering, Dose-dependent hypotension, Arrhythmias, Malignant hyperthermia (rare), Elevations in white blood count, May decrease creatinine and increase BUN, Ileus, severe (fatal), Hepatic dysfunction (postoperative period),Respiratory depression may occur
","Pregnancy Category C. Isoflurane has been shown to have a possible anesthetic-related fetotoxic effect in mice when given in doses 6 times the human dose. There are no adequate and well-controlled studies in pregnant women. Isoflurane should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Isoflurane is administered to a nursing woman.
","Perioperative hyperkalaemia; raised intracranial pressure. May impair ability to drive or operate machinery. Pregnancy and lactation. Do not allow carbon dioxide absorbents in anaesthetic apparatus to dry out when delivering isoflurane to minimise the risk of developing elevated carboxyhaemoglobin levels.
",,,,,"Store at room temperature 15°-30°C. Isoflurane contains no additives and has been demonstrated to be stable at room temperature for periods in excess of five years.
",10
+1572,Irrigating Solution,irrigating-solution-1572,https://medex.com.bd/attachments/GdOxkcvg1xlB7QHnJVPIJOlDFkITBn/irrigating-solution-prescribing-information,Other ophthalmic preparations,Removal of foreign bodies,"Eye Relief removes loose foreign material, air pollutants (smog or pollen), chlorinated water for washing the eye to relieve irritation, stinging, discomfort, itching, burning
","Other ophthalmic preparations
","Eye Relief, eye irrigating solution for eye wash can be used for daily or emergency eye cleansing. Boric Acid has mild antibiotic properties against fungal or bacterial infection. Boric Acid is used in eye wash to cleanse or irrigate the eyes. Boric Acid provides soothing relief from eye irritation, and helps remove pollutants from the eye such as smog, chlorine, or other chemicals
","Instill in the affected eyes as needed or prescribed by the physician.
Using without Eye Cup
+
+- Flush the affected eye(s) as needed
+- Control the rate of flow of solution by pressure on the bottle
+- Do not touch dropper tip to eye
+
+Using with Eye Cup
+
+- Fill the cup upto the 5 ml round mark with Eye Relief eye wash solution and apply the cup to the affected eye(s), pressing tightly to prevent leakage
+- Tilt the head backward. Open eyelids wide and rotate eyeball to wash the eye throughly
+- Rinse cup with clean water after each use
+- Close the cap after use
+
",,,"No data available.
",,"Safe use during pregnancy and lactation has not been established. If pregnant or breast-feeding, ask your doctor before use.
","
+- Do not use if you have open wounds in or near the eyes, and get medical help right away
+- Do not use if solution changes color or becomes cloudy
+- Remove contact lenses before using
+- Do not touch tip of container to any surface to avoid contamination
+- Replace cap after use
+- Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye
+- Condition worsens or persists
+- If swallowed, get medical help or contact a Poison Control Center right away.
+
",,,,,"Store at 15°C to 30°C in a dry place protected from light. It is desirable that the contents should not be used more than one month after first opening of the bottle. Keep out of reach of children.
",8
+406,Iron Sucrose Injection [Elemental Iron],iron-sucrose-injection-elemental-iron-406,https://medex.com.bd/attachments/wUPQt4WFWDaUSNhOWGMOwGM3BeyQUS/iron-sucrose-injection-elemental-iron-prescribing-information,Parenteral Iron Preparations,Peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients receiving an erythropoietin,"This is indicated for the treatment of Iron deficiency in the following indications:
+
+- Where there is a clinical need for a rapid Iron supply
+- In patients who can not tolerate oral Iron therapy or who are non-compliant
+- In active inflammatory bowel disease where oral Iron preparations are ineffective
... Read more
This is indicated for the treatment of Iron deficiency in the following indications:
+
+- Where there is a clinical need for a rapid Iron supply
+- In patients who can not tolerate oral Iron therapy or who are non-compliant
+- In active inflammatory bowel disease where oral Iron preparations are ineffective
+- Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients receiving an erythropoietin
+- Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients not receiving an erythropoietin
+- Hemodialysis dependent-chronic kidney disease (HDD-CKD) patients receiving an erythropoietin
+- Peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients receiving an erythropoietin
+- It is also indicated in the treatment of Iron deficiency anaemia in patients undergoing surgical procedures, patients donating blood, postpartum patients.
+
","Parenteral Iron Preparations
","The therapeutic class of Iron Sucrose is haematinic. Iron Sucrose Injection USP is a brown, sterile, aqueous, complex of Polynuclear Iron (III) Hydroxide in Sucrose for Intravenous use. The drug product contains approximately 30% Sucrose w/v (300 mg/ml) and has a pH of 10.5-11.1. Following intravenous administration, Iron Sucrose Injection is dissociated into Iron and Sucrose by the reticuloendothelial system, and Iron is transferred from the blood to a pool of Iron in the liver and bone marrow. Ferritin, an Iron storage protein, binds and sequesters Iron in a nontoxic form, from which Iron is easily available. Iron binds to plasma transferrin, which carries Iron within the plasma and the extracellular fluid to supply the tissues. The transferrin receptor, located in the cell, and the transferrin-receptor complex is returned to the cell membrane. Transferrin without Iron (apotransferrin) is then released to the plasma. The intracellular Iron becomes (mostly) haemoglobin in circulating red blood cells (RBCs). Transferrin synthesis is increased and ferritin production reduced in Iron deficiency. The converse is true when Iron is plentiful. Its elimination halflife is 6 h, total clearance is 1.2 L/h, non-steady state apparent volume of distribution is 10.0 L and steady state apparent volume of distribution is 7.9 L. In Iron Sucrose, its Iron component appears to distribute mainly in blood and to some extent in extravascular fluid. A significant amount of the administered Iron distributes in the liver, spleen and bone marrow and that the bone marrow is an Iron trapping compartment and not a reversible volume distribution. The sucrose component is eliminated mainly through urinary excretion.
","Adults and Elderly: 5-10 ml Iron Sucrose Injection (100-200 mg Iron) once to three times a week depending on the hemoglobin level.
Children: There is limited data on children under study conditions. If there is a clinical need, it is recommended not to exceed 0.15 ml Iron Sucrose Injection (3 mg Iron) per kg body weight once to three times per week depending on the haemoglobin level.
","Intravenous injection: Iron Sucrose Injection can also be administered undiluted by slow intravenous injection at the (normal) recommended rate of 1 ml Iron Sucrose Injection (20 mg Iron) per minute [5 ml Iron Sucrose Injection (100 mg Iron) in 2 to 5 minutes]. A maximum of 10 ml Iron Sucrose Injection (200 mg Iron) can be injected per injection. Before administration of the therapeutic dose in a new patient, a test dose of 1 ml Iron Sucrose Injection (20 mg Iron) in adults and in children with a body weight greater than 14 kg and half the daily dose (1.5 mg Iron/kg) in children with a body weight less than 14 kg should be injected over 1 to 2 minutes. If no adverse reactions occur within a waiting period of 15 minutes, the remaining portion of the injection can be administered at recommended speed. After an injection the arm of the patient should be extended.
Infusion: Iron Sucrose Injection should preferably be administered by drip infusion (in order to reduce the risk of hypotensive episodes and paravenous injection) in a dilution of 1 ml Iron Sucrose Injection (20 mg Iron) in max. 20 ml 0.9% w/v Sodium Chloride [5 ml (100 mg Iron) in max. 100 ml 0.9% w/v NaCI etc. up to 25 ml (500 mg Iron) in max. 500 ml 0.9% w/v NaCI]. Dilution must take place immediately prior to infusion and the solution should be administered as follows: 100 mg Iron in at least 15 minutes; 200 mg Iron in at least 30 minutes; 400 mg Iron In at least 1.5 hours, and 500 mg Iron in at least 3.5 hours. Further of the maximum tolerated single dose of 7 mg Iron/kg body weight, an Infusion time of at least 3.5 hours has to be respected, independently of the total dose.
Before administration of the therapeutic dose in a new patient the first 20 mg Iron in adults and in children with a body weight greater than 14 kg and half the daily dose (1.5 mg lron/kg) in children with a body weight less than 14 kg should be infused over 15 minutes as a test dose. If no adverse reactions occur, the remaining portion of the infusion can be administered at recommended speed.
","Drug-drug interactions involving Iron Sucrose have not been studied. Iron Sucrose Injection should not be administered concomitantly with oral iron preparations since the absorption of oral Iron is reduced. Even oral Iron therapy should not be given until 5 days after last injection.
","The use of Iron Sucrose is contraindicated in patients with evidence of Iron overload, in patients with known hypersensitivity to Iron Sucrose or any of its inactive components, and in patients with anaemia not caused by Iron deficiency. It is also contraindicated in patients with history of allergic disorders including asthma, eczema and anaphylaxis, liver disease and infections.
","
+- Adverse reactions, whether or not related to Iron Sucrose injection are as follows: hypotension, cramps/leg cramps, nausea, headache, vomiting, and diarrhea. Some of these symptoms may be seen in patients with chronic renal failure or on hemodialysis not receiving intravenous iron.
+- Body as a Whole: headache, fever, pain, asthenia, unwell, malaise, accidental injury. Cardiovascular Disorders
+- General: hypotension, chest pain, hypertension, hypervolemia.
+- Gastrointestinal Disorders: nausea, vomiting, abdominal pain, elevated liver enzymes.
+- Central and Peripheral Nervous System: dizziness.
+- Musculoskeletal System: cramps/leg cramps, musculoskeletal pain.
+- Respiratory System: dyspnea pneumonia, cough.
+- Skin and appendages: pruritus, application site reaction.
+- Hypersensitivity reactions: In safety studies, several patients experienced mild or moderate hypersensitivity reactions presenting with wheezing, dyspnea, hypotension, rashes, or pruritus. Anaphylactoid reactions including patients who experienced serious or life-threatening reactions (anaphylactic shock, loss of consciousness or collapse, bronchospasm with dyspnea, or convulsion) associated with Iron Sucrose administration can occur. So, patients should be given a small test dose initially.
+
","Pregnancy Category-B. No adequate and well controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Iron Sucrose is administered to a nursing woman.
","General: Because body Iron excretion is limited and excess tissue Iron can be hazardous, caution should be exercised to withhold Iron administration in the presence of evidence of tissue Iron overload. Patients receiving Iron Sucrose require periodic monitoring of hematologic and haematinic parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Iron therapy should be withheld in patients with evidence of Iron overload. Transferrin saturation values increase rapidly after IV administration of Iron Sucrose; thus, serum Iron values may be reliably obtained 48 hours after IV dosing.
Hypersensitivity Reactions: Serious hypersensitivity reactions have been rarely reported in patients receiving Iron Sucrose. Several cases of mild or moderate hypersensitivity reactions were observed in these studies.
Hypotension: Hypotension has been reported frequently in hemodialysis patients receiving intravenous Iron. Hypotension following administration of Iron Sucrose may be related to rate of administration and total dose administered. Caution should be taken to administer Iron Sucrose according to recommended guidelines.
","Pediatric Use: Safety and effectiveness of Iron Sucrose in pediatric patients have not been established.
Geriatric Use: No overall differences in safety were observed between the elder subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Injection into dialyser: Iron Sucrose Injection may be administered directly into the venous limb of the dialyser under the same conditions as for intravenous injection.
Hemodialysis Dependent-Chronic Kidney Disease Patients (HDD-CKD): Iron Sucrose Injection may be administered undiluted as a 100 mg slow intravenous injection over 2 to 5 minutes or as an infusion of 100 mg, diluted in a maximum of 100 ml of 0.9% NaCI over a period of at least 15 minutes per consecutive hemodialysis session for a total cumulative dose of 1,000 mg.
Non-Dialysis Dependent-Chronic Kidney Disease Patient (NDD-CKD): Iron Sucrose Injection is administered as a total cumulative dose 1000 mg over a 14 day period as a 200 mg slow IV injection undiluted over 2 to 5 minutes on 5 different occasions within the 14 day period.
","Dosages of Iron Sucrose Injection in excess of Iron needs may lead to accumulation of Iron in storage sites leading to hemosiderosis. Periodic monitoring of Iron parameters such as serum ferritin and transferrin saturation may assist in recognizing Iron accumulation. Iron Sucrose should not be administered to patients with Iron overload and should be discontinued when serum ferritin levels equal or exceed established guidelines. Particular caution should be exercised to avoid Iron overload where anaemia unresponsive to treatment has been incorrectly diagnosed as Iron deficiency anaemia. Symptoms associated with overdosage or infusing Iron Sucrose too rapidly included hypotension, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema. and cardiovascular collapse. Most symptoms have been successfully treated with IV fluids, hydrocortisone, and/or antihistamines. Infusing the solution as recommended or at a slower rate may also alleviate symptoms.
",,,"Store in a cool (15°C- 30°C) & dry place, protected from light. Keep out of the reach of children. Do not freeze.
",13
+631,Iron Polymaltose Complex + Vitamin B Complex + Zinc,iron-polymaltose-complex-vitamin-b-complex-zinc-631,,Iron & Vitamin Combined preparations,Vitamin deficiency,"This syrup is indicated for the treatment and prevention of Iron, Vitamin B complex and Zinc deficiencies, specially during pregnancy and lactation.
","Iron & Vitamin Combined preparations
","This syrup is the preparation of Iron, Vitamin B complex and Zinc. In this preparation, Iron is present as Iron (III) Hydroxide Polymaltose Complex. Iron (III) Hydroxide Polymaltose Complex facilitates a controlled absorption of the iron when it comes in contact with the mucosal cell surface. Due to non-ionic nature, this Iron (III) Hydroxide Polymaltose Complex is more stable than conventional Iron form.
","Adults: 5 ml-10 ml (1-2 teaspoonful) 3 times daily or as recommended by the physician.
Children: 5 ml (1 teaspoonful) 3 times daily or as recommended by the physician.
Infants: 0.33 ml/kg body weight daily or as recommended by the physician.
",,"Since Iron is complex bound, ionic interaction with foodstuff components (phytates, oxalates, tannin etc.) and concomitant administrations of medicaments (tetracyclines, antacids) are unlikely to occur.
","It is contraindicated in patients with a known hypersensitivity to any of the ingredients of this product.
","This syrup is generally well tolerated. However, a few side effects of oral Iron preparations, including nausea, vomiting, constipation or diarrhoea may occur.
","Recommended in pregnancy & lactation
","Caution should be taken in the conditions where there is a risk of Iron overload, such as hemochromatosis, thalassemia, hemosiderosis or hemolytic anemia.
","Recommended in children
","In case of overdose, epigastric pain, diarrhoea, vomiting, metabolic acidosis and convulsion may occur. Should seek emergency medical attention in case of overdose. Initially an emetic should be given and then gastric lavage & general supportive measures should be employed.
",,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",12
+407,Iron Polymaltose Complex + Folic Acid + Zinc Sulfate,iron-polymaltose-complex-folic-acid-zinc-sulfate-407,,"Iron, Vitamin & Mineral Combined preparation","Iron, Folic Acid and zinc deficiency during pregnancy and lactation","This tablet is indicated for the treatment and prevention of Iron, Folic Acid and Zinc deficiencies.
","Iron, Vitamin & Mineral Combined preparation
","This tablet is the preparation of Iron, Folic Acid and Zinc. In this preparation, Iron is present as Iron (III) Hydroxide Polymaltose Complex, a noble Iron preparation. It contains non-ionic Ferric Iron and Polymaltose in a stable complex. This complex facilitates a controlled absorption of the Iron when it comes in contact with the mucosal cell surface. Due to non-ionic nature, Iron (III) Hydroxide Polymaltose Complex is more stable than conventional Iron form. Folic Acid helps in the proper development of the fetus. Zinc keeps enzymes working and helps to metabolize proteins.
","One tablet daily. Two tablets may be required a day in severe cases or as directed by the physician.
",,"Since Iron is complex bound, ionic interaction with foodstuff components (phytates, oxalates, tannin etc.) and concomitant administration of medicaments (tetracyclines, antacids) are unlikely to occur.
","This tablet is contraindicated in patients with a known hypersensitivity to any of the ingredients of this product.
","This tablet is generally well tolerated. However, a few side effects of oral Iron preparations, including nausea, vomiting, constipation or diarrhoea may occur rarely.
","Use of any drug during the first trimester of pregnancy should be avoided if possible. Thus administration of Iron in the first trimester requires definite evidence of Iron deficiency.
","As with all Iron preparations, dark coloration of the stool may occur which is without clinical significance.
",,"No intoxication or Iron overloaded has been reported in case of overdose.
",,,"Keep in a cool & dry place away from light and moisture. Keep out of the reach of children.
",11
+405,Iron Polymaltose Complex + Folic Acid + Zinc + Vitamin B-Complex,iron-polymaltose-complex-folic-acid-zinc-vitamin-b-complex-405,,Iron & Vitamin Combined preparations,Zinc & folic acid deficiency,"This is indicated for the treatment and prophylaxis of Zinc, Iron, Folic Acid, B-vitamins deficiency, especially during pregnancy and lactation.
","Iron & Vitamin Combined preparations
","This is a special preparation of Iron Polymaltose Complex, Folic Acid, Zinc, and B vitamins. Iron Polymaltose Complex is a water soluble, macromolecular complex of poly nuclear iron (III) hydroxide and partially hydrolysed dextrin (Polymaltose). It does not interact with the food components and other medications and so there is no decrease in bioavailability of Iron Polymaltose Complex. This makes sure that with the consumption of this complex, iron gets utilized at a faster rate in the haemoglobin synthesis. Folic acid prevents neural tube defects. Zinc is essential for many metabolic processes, blood formation, wound healing and for immune system. Thiamine is essential for the functioning of the nervous and digestive systems. Riboflavin is important for digestion, immune system support and energy production. Pyridoxin is important for brain development, production of red blood cells, metabolism of proteins and to reduce morning sickness. Nicotinamide is important for energy, blood pressure and circulation.
","One capsule daily. In more severe cases, 2 capsules a day may be required or as directed by the physician.
",,"No drug interactions have been reported.
","This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
","Generally well tolerated. However, a few allergic reactions may be seen.
","Recommended during pregnancy & lactation.
","Care should be taken in patients who may develop iron overloads, such as those with haemochromatosis, haemolytic anaemia or red cell aplasia. Iron chelates with tetracycline and absorption may be impaired.
",,"Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children below 6 years. Avoid higher doses if you have liver disease or hemochromatosis; excess can cause bloody diarrhea, vomiting, acidosis, darkened stools, abdominal pain. Symptoms may clear in a few hours. Riboflavin is reported to be completely safe and no toxic symptoms have been reported so far. Higher doses of Nicotinamide may cause vomiting, diarrhea. Sensory neuropathy was observed in individuals consuming more than 200 mg Pyridoxine for very long periods. No case of Folic acid overdose has been reported. Zinc toxicity has been seen in both acute and chronic forms. Ingestion of 150 to 450 mg of zinc per day has been associated with low copper status, altered iron function, reduced immune function, and reduced levels of high-density lipoproteins. So, Zinc at its RDA dosage does not cause any significant effect.
",,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",11
+630,Iron Polymaltose Complex,iron-polymaltose-complex-630,,Oral Iron preparations,Iron deficiency,"Iron Polymaltose Complex is indicated for the-
+
+- Treatment of latent iron deficiency and iron deficiency anaemia including macrocytic anaemia,nutritional anaemia of infants, anaemia due to excessive haemorrhage and anaemia associated with infections and malignant disease.
+- Prevention and treatment of iron deficiency anaemia before, during and after pregnancy and during lactation.
... Read more
Iron Polymaltose Complex is indicated for the-
+
+- Treatment of latent iron deficiency and iron deficiency anaemia including macrocytic anaemia,nutritional anaemia of infants, anaemia due to excessive haemorrhage and anaemia associated with infections and malignant disease.
+- Prevention and treatment of iron deficiency anaemia before, during and after pregnancy and during lactation.
+- For prophylactic therapy of iron deficiency to cover the recommended daily dietary allowances (RDA).
+
","Oral Iron preparations
","Iron Polymaltose Complex is a polysaccharide-iron complex, which is a novel iron preparation used in the treatment of iron deficiency anaemia. Iron, an essential constituent of the body, is necessary for haemoglobin formation and for the oxidative process of living tissue. This preparation contains non-ionic ferric iron and polymaltose in a stable complex. This facilitates a controlled absorption of the ferric iron when it comes in contact with the mucosal cell surface. Being non-ionic, it does not release any free radicals and thus takes care of all the toxic effects found due to the release of free radicals by the traditional ionized iron salt preparations. It does not interact with the food components and other medications and so, unlike ferrous salts, there is no decrease in bioavailability of Iron Polymaltose Complex. This makes sure that with the consumption of this complex, iron gets utilized at a faster rate in the haemoglobin and myoglobin synthesis.
","Dosage and duration of therapy are dependent upon the extent of iron deficiency and should be taken as directed by the physician.
+
+- Adults: 10 ml once or twice daily
+- Children (6-12 years): 10 ml daily
+- Children (2-6 years): 5 ml daily
+- Premature infants & Infants: 3.33 mg of elemental iron/kg body weight.
+
",,"Generally no interactions have been observed. Since, the iron is complex bound, ionic interactions with foodstuff components (phytates, oxalates, tannin, etc.) and concomitantly administered medicaments (tetracycline, antacids) are unlikely to occur.
","
+- In conditions where there is a risk of iron overload e.g. haemochromatosis, thalassemia or
haemosiderosis.
+- In case of hypersensitivity to iron or any other ingredients of the syrup.
+
","This preparation is well tolerated. However, a few side effects of oral iron preparations, including nausea, vomiting, constipation or diarrhoea may occur.
","Administration of drugs during first trimester of pregnancy requires careful assessment of potential risk versus benefits to be gained and should not be administered unless clearly indicated. For the remainder of the pregnancy, iron therapy may be indicated but only on advice of a physician. Iron is excreted in breast milk but not in clinically significant concentrations.
","Initially epigastric pain, diarrhea and vomiting; and may include metabolic acidosis, convulsions, and coma after apparent recovery. Speed is essential for effective treatment which is dependent upon removing excess iron from the alimentary tract prior to absorption. Initially an emetic should be given, followed by gastric lavage with 1% sodium bicarbonate, and oral administration of desferrioxamine to complex with residue.
",,"In case of overdosage, initially epigastric pain, diarrhoea and vomiting can occur and may include metabolic acidosis, convulsions and coma after apparent recovery. Should seek emergency medical attention in case of overdose. Initially an emetic should be given and then gastric lavage and general supportive measures should be employed.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+1673,Iron Hydroxide Polymaltose + Folic acid + Zinc Sulfate Monohydrate,iron-hydroxide-polymaltose-folic-acid-zinc-sulfate-monohydrate-1673,,"Iron, Vitamin & Mineral Combined preparation",Zinc & folic acid deficiency,"This is indicated in the prevention and treatment of Iron, Folic Acid and Zinc deficiencies.
","Iron, Vitamin & Mineral Combined preparation
",,"One tablet daily or two tablets may be required a day in severe cases or as directed by the physician.
",,,,,,,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",4
+629,Iron + Folic Acid + Vitamin B Complex + Vitamine C + Zinc Sulfate,iron-folic-acid-vitamin-b-complex-vitamine-c-zinc-sulfate-629,,Iron & Vitamin Combined preparations,Vitamin deficiency,"This is indicated for the treatment and prophylaxis of Zinc, Iron, Folic Acid, B-vitamins and Vitamin-C deficiency especially during pregnancy and lactation.
","Iron & Vitamin Combined preparations
","Zinc sulfate precipitates protein and this is responsible for the astringent and weak antiseptic activity of Zn sulfate. It also produces mild vasodilation. Zinc sulfate can also be used orally or systemically as a zinc supplement. 220 mg of zinc sulfate (heptahydrate) contains 50 mg of elemental zinc.
Iron is an essential mineral, with several important roles in the body. For example, it helps to make red blood cells, which carry oxygen around the body. A lack of iron can lead to iron deficiency anaemia. Liver is a good source of iron, don't eat it if you are pregnant. This is because it is also rich in vitamin A which, in large amounts, can harm your unborn baby.
Folic acid is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. It is also essential in the synthesis and maintenance of nucleoprotein in erythropoesis. It also promotes WBC and platelet production in folate-deficiency anaemia.
Nicotinamide is a vitamin B3 derivative. It is incorporated into coenzymes nicotinamide adenine dinucleotide (NAD) and nicotinamide adenine dinucleotide phosphate (NADP), which are involved in multiple cellular metabolic pathways.
Vitamin C is necessary for collagen formation and tissue repair; plays a role in oxidation/reduction reactions as well as other metabolic pathways including synthesis of catecholamines, carnitine, and steroids; also plays a role in conversion of folic acid to folinic acid.
Vitamin B complex: The building blocks for good health come from a variety of foods, even if they are from the same family of nutrients. Such is the case with vitamin B, a key player in maintaining cell health and keeping you energized.
Not all types of vitamin B do the same thing. Additionally, the different types of vitamin B all come from different types of foods.
Vitamin B deficiencies can lead to health problems. Sometimes a doctor will prescribe a supplement when they think you’re not getting enough.
","One capsule daily. In more severe cases, 2 capsules a day may be required or as directed by the physician.
",,,"This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
","Generally well tolerated. However, a few allergic reactions may be seen.
","Recommended.
","Care should be taken in patients who may develop iron overload, such as those with haemochromatosis, haemolytic anaemia or red cell aplasia. Iron chelates with tetracycline and absorption may be impaired.
",,"Accidental overdose of iron containing products is a leading cause of fatal poisoning in children below 6 years. Avoid higher doses if you have liver disease or haemochromatosis; excess can cause bloody diarrhea, vomiting, acidosis, darkened stools, abdominal pain. Symptoms may clear in a few hours.
Riboflavin is reported to be completely safe and no toxic symptoms have been reported so far. Higher doses of Nicotinamide may cause vomiting, diarrhea. Sensory neuropathy was observed in individuals consuming more than 200 mg Pyridoxine for very long periods. No case of Folic acid overdodage has been reported.
Acute ingestion of Ascorbic acid, even of massive doses, is unlikely to cause significant effects.
Zinc toxicity has been seen in both acute and chronic forms. Ingestion of 150 to 450 mg of zinc per day have been associated with low copper status, altered iron function, reduced immune function, and reduced levels of high-density lipoproteins. So, Zinc at its RDA dosages dose not cause any significant effect.
",,,"Store in a dry place below 25 °C. Protect from light.
",10
+628,Iron + Folic acid + Vitamin B complex + Vitamin C,iron-folic-acid-vitamin-b-complex-vitamin-c-628,,Iron & Vitamin Combined preparations,Vitamin deficiency,"This is indicated for the treatment and prophylaxis of Iron, Folic acid, Vitamin B complex and Vitamin C deficiency, or to meet extra need of these vitamins and minerals especially in pregnancy or when planning for pregnancy.
","Iron & Vitamin Combined preparations
","Iron is an essential mineral, with several important roles in the body. For example, it helps to make red blood cells, which carry oxygen around the body. A lack of iron can lead to iron deficiency anaemia. Liver is a good source of iron, don't eat it if you are pregnant. This is because it is also rich in vitamin A which, in large amounts, can harm your unborn baby.
Folic acid is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. It is also essential in the synthesis and maintenance of nucleoprotein in erythropoesis. It also promotes WBC and platelet production in folate-deficiency anaemia.
Vitamin C is necessary for collagen formation and tissue repair; plays a role in oxidation/reduction reactions as well as other metabolic pathways including synthesis of catecholamines, carnitine, and steroids; also plays a role in conversion of folic acid to folinic acid.
Vitamin B complex: The building blocks for good health come from a variety of foods, even if they are from the same family of nutrients. Such is the case with vitamin B, a key player in maintaining cell health and keeping you energized.
Not all types of vitamin B do the same thing. Additionally, the different types of vitamin B all come from different types of foods.
Vitamin B deficiencies can lead to health problems. Sometimes a doctor will prescribe a supplement when they think you’re not getting enough.
","Recommended adult dose is one capsule daily. In more severe deficiency states, 2 capsules a day may be required or as directed by the physician.
",,"Care should be taken when given to patients with Iron storage or Iron absorption disease. Iron form chelates with antacids and Tetracycline and absorption of all these may be impaired if taken concurrently
","This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Iron therapy is contraindicated in haemachromatosis and haemosiderosis, and in patients receiving repeated blood transfusion or with anaemia not due to by iron deficiency. It should be given cautiously to patients taking Levodopa as one of the ingredients (Pyridoxine) reduces the effect of Levodopa.
","Generally well tolerated. However, a few allergic reactions may be seen.
","It is recommended during pregnancy and lactation.
","Care should be taken in patients who may develop iron overload, such as those with hemochromatosis, haemolytic anaemia or red cell aplasia. Iron chelates with tetracycline and absorption may be impaired.
",,"Accidental overdose of iron containing products is a leading cause of fatal poisoning in children fewer than 6. Avoid higher doses if you have liver disease or hemochromatosis; excess can cause bloody diarrhea, vomiting, acidosis, darkened stools, abdominal pain. Symptoms may clear in a few hours. Riboflavin is reported to be completely safe and no toxic symptoms have been reported so far. Higher doses of Nicotinamide may cause vomiting, diarrhea. Sensory neuropathy was observed in individuals consuming more than 200 mg Pyridoxine for very long periods. No cases of Folic acid overdosages have been reported. Acute ingestion of Ascorbic acid, even of massive doses, is unlikely to cause significant effects.
",,,"Store in a dry place below 25° C. Protect from light.
",11
+659,Iron + Folic Acid + Vitamin A + Vitamin C + Zinc,iron-folic-acid-vitamin-a-vitamin-c-zinc-659,https://medex.com.bd/attachments/IYgV2y3tckaE2w0vWGN8zjCNamnViY/iron-folic-acid-vitamin-a-vitamin-c-zinc-prescribing-information,"Iron, Vitamin & Mineral Combined preparation",Vitamin deficiency,"Anemia is one of the leading causes of malnutrition among children under five years of age. In Bangladesh, more than 50% of under five children have been suffering from iron deficiency anemia (IDA). This powder is effective for treatment and prevention of anemia. It is a tasteless and odorless micronutrient ... Read more
Anemia is one of the leading causes of malnutrition among children under five years of age. In Bangladesh, more than 50% of under five children have been suffering from iron deficiency anemia (IDA). This powder is effective for treatment and prevention of anemia. It is a tasteless and odorless micronutrient powder.
This preparation is used for-
+
+- Prevents and treats micronutrient deficiencies and improves overall nutrition status of children (6-24 months).
+- Increases brain development and physical growth.
+- Increases attention to and improves concentration in different activities such as education, games & sports, etc.
+- Enhances learning ability and memory functions.
+- Increases resistance to diseases and reduces infections.
+- Increases appetite.
+
","Iron, Vitamin & Mineral Combined preparation
",,"This is most suited to children from the age of 6-23 months. As recommended by WHO, this preparation is very effective in addressing iron and micronutrient deficiency anemia among under five children.
The dose is-
+
+- Feed this to children by mixing with semi-solid or soft food (rice, hotchpotch, suji etc).
+- When child becomes hungry, mix one sachet of this preparation with a small quantity of child’s main meal of the day and feed it in full within half-an hour.
+- Feed one sachet of this preparation to a child daily to be continued for 2 months, then 4 months interval and continue for another 2 months. Following same process, feed this preparation to children up to 59 months of age.
+
",,,"This is prohibited for children affected thalassemia, sickle cell anemia, and HIV/AIDS.
","Apparently this has no side effect but due to the presence of iron in this preparation, stool of a child could be hard or soft and it’s color may also be blackish and after few days it would become normal.
",,"
+- This is not applicable for children who are hospitalized or affected by acute malnutrition. In case of recovery and if the child begins to take food normally and then this could be fed again.
+- This preparation should not be mixed with too hot, liquid or hard food.
+- Do not feed This preparation to your child while it (sachet) is torn, abandoned or it’s shelf life expired.
+
",,,,,"This should be stored in a dry place protected from light where temperature might be below 30°C.
",7
+658,Irinotecan Hydrochloride,irinotecan-hydrochloride-658,https://medex.com.bd/attachments/YFzUUaSWUUEjqRdxG1dN7MOrnkseaF/irinotecan-hydrochloride-prescribing-information,Cytotoxic Chemotherapy,Stomach carcinoma,"Irinotecan Injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum.
Irinotecan is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.
","Cytotoxic Chemotherapy
","Irinotecan inhibits the action of topoisomerase I. Irinotecan prevents religation of the DNA strand by binding to topoisomerase I-DNA complex. The formation of this ternary complex interferes with the moving replication fork, which induces replication arrest and lethal double-stranded breaks in DNA. As a result, DNA damage is not efficiently repaired and apoptosis (programmed cell death) occurs.
","Administer as a 90-minute intravenous infusion followed by LV and 5-FU. A reduction in the starting dose by one dose level may be considered for patients with any of the following conditions: prior pelvic/abdominal radiotherapy, performance status of 2, or increased bilirubin levels.
Refractory colorectal malignancies: 125 mg/m2 once wkly for 4 wk, followed by a 2 wk rest period.
Metastatic colorectal cancer: As 1st line treatment: 125 mg/m2 on days 1,8,15 and 22 of a 6-wk cycle.
",,"Diuretics increase risks of dehydration secondary to vomiting/diarrhoea; prophylactic dexamethasone as an antiemetic may enhance lymphocytopenia; prochlorperazine may increase incidence of akathisia; antineoplastic agents (myelosuppression and diarrhoea). St John's wort, ketoconazole may reduce irinotecan exposure.
","Patients with a known hypersensitivity to the drug or its excitements.
","Anemia, Leukopenia, Neutropenia,Thrombocytopenia, Elevated bilirubin, Diarrhea, Nausea, Asthenia, Abdominal pain, Vomiting , Alopecia, Fever, Constipation, Anorexia, Mucositis, Pain, Dyspnea, Cough, Dizziness, Infection, Rash, Abdominal fullness, AST increased , Dyspepsia, Edema, Ascites/jaundice, Vasodilation, Thromboembolism, Hypotension, Neutropenic fever, Headache, Insomnia, Orthostatic hypotension
","Pregnancy Category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
","Early diarrhea is usually transient and infrequently severe. It may be accompanied by cholinergic symptoms of rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing, and intestinal hyperperistalsis that can cause abdominal cramping. Bradycardia may also occur.
Late diarrhea can be life threatening since it may be prolonged and may lead to dehydration, electrolyte imbalance, or sepsis.Late diarrhea can be complicated by colitis, ulceration, bleeding, ileus, obstruction, and infection. Cases of megacolon and intestinal perforation have been reported.
",,,,,"Store at controlled room temperature 15° to 30°C. Protect from light. Keep the vial in the carton until the time of use.
",10
+565,Irbesartan + Hydrochlorothiazide,irbesartan-hydrochlorothiazide-565,https://medex.com.bd/attachments/TCAF3q0jgWdzmguqzXsGjos3QrIHqJ/irbesartan-hydrochlorothiazide-prescribing-information,Combined antihypertensive preparations,Hypertension,"Irbesartan & Hydrochlorothiazide tablet are indicated for the treatment of hypertension. This tablet may be used in patients whose blood pressure is not adequately controlled on monotherapy. This tablet may also be used as initial therapy in patients who are likely to need multiple drugs to achieve ... Read more
Irbesartan & Hydrochlorothiazide tablet are indicated for the treatment of hypertension. This tablet may be used in patients whose blood pressure is not adequately controlled on monotherapy. This tablet may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of Irbesartan & Hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks.
Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy.
","Combined antihypertensive preparations
","Irbesartan: Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the RAS and also stimulates aldosterone synthesis and secretion by adrenal cortex, cardiac contraction, renal resorption of sodium, activity of the sympathetic nervous system, and smooth muscle cell growth. Irbesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively binding to the AT1 angiotensin II receptor. There is also an AT2 receptor in many tissues, but it is not involved in cardiovascular homeostasis.
Irbesartan is a specific competitive antagonist of AT1 receptors with a much greater affinity (more than 8500-fold) for the AT1 receptor than for the AT2 receptor, and no agonist activity.
Blockade of the AT1 receptor removes the negative feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and circulating angiotensin II do not overcome the effects of irbesartan on blood pressure.
Irbesartan does not inhibit ACE or renin or affect other hormone receptors or ion channels known to be involved in the cardiovascular regulation of blood pressure and sodium homeostasis. Because irbesartan does not inhibit ACE, it does not affect the response to bradykinin; whether this has clinical relevance is not known.
Hydrochlorothiazide: Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so coadministration of an angiotensin II receptor antagonist tends to reverse the potassium loss associated with these diuretics.
","Initial therapy: Irbesartan 150 mg & Hydrochlorothiazide 12.5 mg orally once a day; may increase after 1 to 2 weeks.
Add-on/Replacement therapy: Irbesartan 150 to 300 mg & Hydrochlorothiazide 12.5 to 25 mg orally once a day
Maximum dose: Irbesartan 300 mg & Hydrochlorothiazide 25 mg orally once a day
",,"Other antihypertensives, lithium, K-sparing diuretics, K supplements, salt substitutes containing K. CNS depressants, antidiabetics, cholestyramine & colestipol resins, corticosteroids, ACTH, digitalis glycosides, antiarrhythmics, NSAIDs, tubocurarine, antigout medications, Ca salts. Alcohol; diazoxide, atropine, beperiden, amantadine, cyclophosphamide, methotrexate.
","Irbesartan and Hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to any component of this product. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Do not coadminister aliskiren with Irbesartan and Hydrochlorothiazide tablets in patients with diabetes
","Irbesartan: Hyperkalemia (19%), Chest pain (2%), Tachycardia (1%), Abnormal urination (2%), Musculoskeletal pain (6%), Flu-like syndrome (3%), Edema (3%), Tachycardia (1%), Chest pain (2%), Creatinine increased (1%), Increased BUN (2%), Dizziness (10%), URI (9%), Orthostatic hypotension (5%), Fatigue (4%), Diarrhea (3%), Dyspepsia (2%)
Hydrochlorothiazide: Anorexia, Epigastric distress, Hypotension, Orthostatic hypotension, Photosensitivity, Anaphylaxis, Anemia, Confusion, Erythema multiforme, Stevens-Johnson syndrome, Exfoliative dermatitis including toxic epidermal necrolysis, Dizziness, Hypokalemia and/or hypomagnesemia, Hyperuricemia, Headache
","Pregnancy Category D. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Irbesartan and Hydrochlorothiazide as soon as possible.
Thiazides cross the placenta, and use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.
Nursing Mothers: It is not known whether irbesartan is excreted in human milk, but irbesartan or some metabolite of irbesartan is secreted at low concentration in the milk of lactating rats.
Thiazides appear in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
","Child: Do not nurse
Lactation: Discontinue drug or do not nurse
","Renal Dose Adjustments:
+
+- Mild to moderate renal dysfunction (CrCl 30 mL/min or greater): No adjustment recommended
+- Severe renal dysfunction (CrCl less than 30 mL/min): Not recommended
+
+
Liver Dose Adjustments: Caution recommended
","Irbesartan: No data are available in regard to overdosage in humans. However, daily doses of 900 mg for 8 weeks were well tolerated. The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose. Irbesartan is not removed by hemodialysis.
To obtain up-to-date information about the treatment of overdosage, a good resource is a certified regional Poison Control Center. Telephone numbers of certified Poison Control Centers are listed in the Physicians’ Desk Reference (PDR). In managing overdose, consider the possibilities of multiple-drug interactions, drug-drug interactions, and unusual drug kinetics in the patient.
Laboratory determinations of serum levels of irbesartan are not widely available, and such determinations have, in any event, no established role in the management of irbesartan overdose.
Acute oral toxicity studies with irbesartan in mice and rats indicated acute lethal doses were in excess of 2000 mg/kg, about 25- and 50-fold the MRHD (300 mg) on a mg/m2 basis, respectively.
Hydrochlorothiazide: The most common signs and symptoms of overdose observed in humans are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. The oral LD50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats.
",,,"Should be stored in cool and dry place
",12
+650,L-Lysine Hydrochloride,l-lysine-hydrochloride-650,,Dressing products for wounds/burns/ulcers,Wounds,"For the treatment and prevention of infection in cuts, wounds abrasion, surgical incisions and burns. For the treatment of decubitus or stasis ulcers, advance chronic wounds, infected traumatic lesions etc.
","Dressing products for wounds/burns/ulcers
","The active ingredient, Lysine hydrochloride is an essential amino acid, soluble in water; has been observed to promote in-situ cellular expansion in acute and chronic wound beds, in presence of blood plasma derived growth factor(s). The essential amino acid promotes healing of wounds by active and controlled regeneration of in-situ cells. It also protects the wounds against common organisms.
","Gel or Ointment may be used as often as required, preferably at an interval of 24, 48, 72 hrs. The affected areas should be cleaned with normal saline and/or surgically if necessary till the wound bed looks red/few bleeding points appear in the cleaned wound bed. Then gel should be applied liberally. The areas may be covered with a moist dressing and/or a bandage.
",,,"Not to be used in known cases of hypersensitivity to the amino acid. No other known contraindication is known for this essential amino acid.
","Slight itching sensation might be there on application.
","No information provided.
","In cases of discomfort on application, please consult with the physician.
",,"No known adverse reactions/side effects are known for the essential amino acid.
",,,"Store in a cool and dry place, protected from light.
",10
+649,Ketotifen Fumarate (Oral),ketotifen-fumarate-oral-649,https://medex.com.bd/attachments/HRT26OK8e9AgPvtUFIls9wwpZurN2N/ketotifen-fumarate-oral-prescribing-information,Cromoglycate & related drugs,Asthma prophylaxis,"Ketotifen is indicated in the following conditions-
+
+- For the prophylactic treatment of bronchial asthma.
+- Symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.
+- For alleviating the complications of itching, pain and tenderness associated with neurofibroma.
+- Symptomatic treatment of allergy such as hayfever, urticaria.
+
","Cromoglycate & related drugs
","Ketotifen has anti-allergic properties and has been used similarly, to sodium chromoglycate in the prophylactic treatment of asthma. It also has the properties of an antihistamine. Ketotifen possesses marked anti-anaphylactic properties and is effective in preventing an asthmatic attacks. Ketotifen exerts as sustained inhibitory effect on histamine reactions, which can be clearly dissociated from its anti-anaphylactic properties. Experimental investigations in asthmatic subjects have shown that Ketotifen is as effective orally as a selective mast cell stabilizer administered by inhalation. Antihistamines were ineffective in those tests. The effectiveness of Ketotifen has been studied in long-term clinical trials. Asthma attacks were reduced in number, severity and duration and in some cases, the patients were completely freed from attacks. Progressive reduction of corticosteroids and/or bronchodilators was also possible. The prophylactic activity of Ketotifen may take several weeks to become fully established. Ketotifen will not abort established attacks of asthma.
","Adults: 1 mg twice daily with food. If necessary the dose may be increased to 2 mg twice daily in severe cases.
Children above 3 years: 1 mg twice daily with food. Patients known to be easily sedated should begin treatment with 0.5 to 1 mg at night for the first few days or as directed by the physician.
Use in elderly: Same as adult dose or as advised by the physician.
",,"Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohols. A reversible fall in the platelet count has been observed in a few patients receiving Tifen concomitantly with oral antidiabetic agents and it has been suggested that this combination should therefore be avoided.
","A reversible fall in the platelet count has been observed in a few patients receiving Ketotifen concomitantly with oral antidiabetic agent and it has been suggested that this combination should therefore be avoided. Although there is no evidence of any teratogenic effect, recommendations for Ketotifen in pregnancy or when breast feeding can not be given.
","Drowsiness and in isolated cases, dry mouth and slight dizziness may occur at the beginning of treatment but usually disappear spontaneously after a few days.
","Although there is no evidence of any teratogenic effect, Ketotifen in pregnancy and lactation is not recommended.
","It is important to continue the previous treatment for a minimum of two weeks after starting Ketotifen to avoid the possibility of exacerbation of asthma. This applies specially to systemic corticosteroids and ACTH because of the possible existence of adrenocortical insufficiency in steroid dependent patient. If inter current infection occurs, Ketotifen treatment must be supplemented by specific antimicrobial therapy. During the first day of treatment with Ketotifen, reactions may be impaired and patients should be warned not to take charge of vehicle or machinery until the effect of Ketotifen treatment on the individual is known. Patients should be advised to avoid alcoholic drinks. Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohol.
",,"The reported features of overdosage include confusion, drowsiness, headache, bradycardia, respiratory depression etc. should be watched for. Elimination of the drug with gastric lavage or emessis is recommended. Otherwise, general supportive treatment is all that is required shall be instituted.
",,,"Store in a cool and dry place, protect from light. Keep out of the reach of children.
",11
+1311,Ketotifen Fumarate (Ophthalmic),ketotifen-fumarate-ophthalmic-1311,https://medex.com.bd/attachments/9W18a07yxEJguLRYf9BK4QyMOalfn6/ketotifen-fumarate-ophthalmic-prescribing-information,Ophthalmic Non-Steroid drugs,Watery eye,"Ketotifen eye drop is indicated for the treatment of signs & symptoms (itchy, watery, red & swollen eyes and eyelids) of allergic conjunctivitis including vernal kerato-conjunctivitis, vernal-keratitis, blepharitis, blepharo-conjunctivitis, and giant papillary conjunctivitis.
","Ophthalmic Non-Steroid drugs
","Ketotifen is a potent anti-allergic substance possessing a powerful and sustained non-competitive histamine (H1) receptor blocking property. Ketotifen inhibits the release of mediators (e.g histamine, leukotrienes and prostaglandins) from cells responsible for type-(I) allergic reactions. Ketotifen also stabilizes mast cells, decreases chemotaxis, activation of degranulation of eosinophils.
","Adults and children 3 years and older: 1 drop in the affected eye(s) twice daily, every 8-12 hours, not more than twice per day.
Children under 3 years of age: Consult with a doctor.
",,"If Ketotifen eye drops is used concomitantly with other eye medications there must be an interval of at least 5 minutes between the two medications.
","Hypersensitivity to Ketotifen or any of the components
","Common side effects are burning, stinging, punctate corneal epithelial erosion, Blurring of vision upon drug instillation, dry eyes, eyelid disorder, conjunctivitis, eye pain, photophobia, subconjunctival haemorrhage.
","There are no adequate data from the use of ketotifen eye drops in pregnant women. Systemic levels after ocular administration are much lower than after oral use. Caution should be exercised when prescribing to pregnant women. Although animal data following oral administration show excretion into breast milk, topical administration to humans is unlikely to produce detectable quantities in breast milk. ketotifen 0.25% eye drops can be used during lactation.
","The formulation of Ketotifen 0.025% eye drops contains benzalkonium chloride as a preservative, which may be deposited in soft contact lenses; therefore this eye drops should not be instilled while the patient is wearing lenses. The lenses should be removed before application of the drops and not reinserted earlier than 15 minutes after use.
",,"No case of overdose has been reported. Oral ingestion of the contents of a 5 ml bottle would be equivalent to 1.25 mg of Ketotifen which is 60% of a recommended oral daily dose for a 3 years old child. Clinical results have shown no serious signs or symptoms after oral ingestion of up to 20 mg of Ketotifen.
",,,"Store in a cool and dry place protected from light and moisture. Keep out of reach of children. Do not touch the dropper tip to any surface since this may contaminate the solution. Do not use after 30 days of first opening.
",11
+1307,Ketorolac Tromethamine (Ophthalmic),ketorolac-tromethamine-ophthalmic-1307,https://medex.com.bd/attachments/BgeMzk1E0AsgO5Hixi8AhTJS3Kqyli/ketorolac-tromethamine-ophthalmic-prescribing-information,Non opioid analgesics,Postoperative eye inflammation,"Ketorolac Tromethamine is indicated for seasonal allergic conjunctivitis and for pain and inflammation in ocular surgery. It is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.
","Non opioid analgesics, Non-Opioid Analgesics
","Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) chemically related to indomethacin and tolmetin. Ketorolac tromethamine is a racemic mixture of [-]S- and [+]R-enantiomeric forms, with the S-form having analgesic activity. Its antiinflammatory effects are believed to be due to inhibition of both cylooxygenase-1 (COX-1) and cylooxygenase-2 (COX-2) which leads to the inhibition of prostaglandin synthesis leading to decreased formation of precursors of prostaglandins and thromboxanes from arachidonic acid. The resultant reduction in prostaglandin synthesis and activity may be at least partially responsible for many of the adverse, as well as the therapeutic, effects of these medications. Analgesia is probably produced via a peripheral action in which blockade of pain impulse generation results from decreased prostaglandin activity. However, inhibition of the synthesis or actions of other substances that sensitize pain receptors to mechanical or chemical stimulation may also contribute to the analgesic effect. In terms of the ophthalmic applications of ketorolac - ocular administration of ketorolac reduces prostaglandin E2 levels in aqueous humor, secondary to inhibition of prostaglandin biosynthesis.
","For the treatment of relief of ocular itching due to seasonal allergic conjunctivitis, one drop (0.25 mg) four times a day. For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop should be applied to the affected eye(s) four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period. It has been safely administered in conjunction with other ophthalmic medications such as antibiotics, beta blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics.
",,"No information available.
","Contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.
","Transient stinging and burning on instillation, allergic reactions, corneal edema, iritis, ocular inflammation, ocular irritation, superficial keratitis and superficial ocular infections. Corneal infiltrates, corneal ulcer, eye dryness, headaches, and visual disturbance (blurry vision)
","Pregnancy Category C: There is no adequate and well-controlled studies in pregnant women. The drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The use of drug during late pregnancy should be avoided.
Nursing Mothers: Caution should be exercised when ophthalmic solution is administered to a nursing woman.
","All topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDS and topical steroids may increase the potential for healing problems. Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.
There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs. With some nonsteroidal antiinflammatory drugs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues in conjunction with ocular surgery.
","Pediatric Use: Safety and efficacy in pediatric patients below the age of 3 have not been established.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
",,,,"Store in a cool and dry place, away from light Keep out of reach of children.
",11
+648,Ketorolac Tromethamine,ketorolac-tromethamine-648,https://medex.com.bd/attachments/C9hXI3bjZBt7ytZQQQ33A4vS07cRrz/ketorolac-tromethamine-nasal-spray-prescribing-information,Drugs used for Rheumatoid Arthritis,Soft tissue inflammation,"Ketorolac Tromethamine is indicated for the short-term management of moderate to severe acute post-operative pain.
","Drugs used for Rheumatoid Arthritis, Non-Opioid Analgesics
","Ketorolac Tromethamine is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAIDs). It acts by inhibiting the cyclooxygenase enzyme system and hence inhibits the prostaglandin synthesis. It demonstrates a minimal anti-inflammatory effect at its analgesic dose.
","Tablet-
+Recommended dose is 10 mg every 4-6 hours. It should be used short-term only (up to 7 days) and are not recommended for chronic use. Doses exceeding 40 mg/day is not recommended.
+
Injection-
+Ketorolac injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Ketorolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.
Single-Dose Treatment-
IM Dosing (Adult):
+
+- Patients <65 years of age: One dose of 60 mg.
+- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg.
+
+IV Dosing (Adult):
+
+- Patients <65 years of age: One dose of 30 mg.
+- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg.
+
+IV or IM Dosing (2 to 16 years of age):
+
+- IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg.
+- IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg.
+
+Multiple-Dose Treatment (IV or IM)-
+
+- Patients <65 years of age: The recommended dose is 30 mg Ketorolac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.
+- Conversion from Parenteral to Oral Therapy: Ketorolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Ketorolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac IM should be replaced by Ketorolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days.
+
",,"Other NSAIDs or aspirin: Increase the side effects of ketorolac Tromethamine.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
","Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs. It should not be used in children under 16 years of age. lt is also contraindicated as prophylactic analgesic before surgery.
","Commonly occurring side effects are nausea, vomiting, gastro-intestinal bleeding, melana, peptic ulcer, pancreatitis, anxiety, drowsiness, headache, excessive thirst, fatigue, bradycardia, hypertension, palpitation, chest pain, infertility in female and pulmonary edema.
","US FDA Pregnancy category of Ketorolac Tromethamine is C. So, Ketorolac Tromethamine should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
","Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected peptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction.
",,,,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",10
+1773,Ketoprofen (Topical),ketoprofen-topical-1773,https://medex.com.bd/attachments/Bi8mQZEsPwNBW3SG9Pm4WZSVhqNw1b/ketoprofen-topical-prescribing-information,Non-steroidal Anti-inflammatory Drugs (NSAIDs),Pain,"For the symptomatic treatment of mild to moderate local pain associated with muscle and/or joints injuries, e.g. sport injuries.
","Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic actions. In addition to the inhibition of prostaglandin synthesis, it stabilizes lysosomal membranes in vitro and in vivo, inhibits leukotriene synthesis in vitro at high concentrations, and also exhibits antibradykinin activity in vivo. Ketoprofen produces analgesia by inhibiting the synthesis of prostaglandins peripherally and centrally. It has also been suggested that Ketoprofen causes the suppression of prostaglandin synthesis in the CNS (probably in the hypothalamus) leading to its antipyretic effect.
","Adults: The gel should be applied on to the painful or inflamed area two to three times daily. The amount of gel should be adjusted so that it covers the painful area. The total daily dose shall not exceed 15 grams per day. The length of treatment should not exceed one week. The gel should be massaged onto the skin for a few minutes.
Children: The safety and efficacy of Ketoprofen gel in children have not been established.
",,"Interactions are unlikely as serum concentrations following topical administration are low.
","Ketoprofen gel must not be used in patients with:
+
+- Known hypersensitivity reactions, such as symptoms of asthma, allergic rhinitis or urticaria, to ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid, or other non-steroidal anti-inflammatory agents.
+- History of hypersensitivity to any of the excipients.
+- History of photosensitivity reactions.
+- History of cutaneous reactions to ketoprofen, tiaprofenic acid, fenofibrate, UV blockers or perfumes.
+
+Ketoprofen gel must not be used on pathological skin changes such as eczema or acne; or in infected skin or open wounds. Do not use Ketoprofen gel if you cannot avoid sun exposure, even hazy sun, including UV light from solarium, during treatment and for 2 weeks after its discontinuation.
","Immune System disorders- Not known: Anaphylactic shock, angioedema, hypersensitivity reactions.
Gastrointestinal disorders- Although plasma levels after administration of Ketoprofen gel are much lower than those reached after oral administration, systemic gastrointestinal side effects (such as nausea, abdominal pain, vomiting, and flatulence) are possible under rare circumstances depending on the amount of gel applied and the application of the gel to a large area of skin. Uncommon: Nausea. Not known: Abdominal pain, vomiting, flatulence.
Skin and Subcutaneous tissue disorders- Uncommon: Erythema, pruritus, eczema. Rare: Photosensitivity reactions, dermatitis bullous, urticaria. Localised skin reactions have been reported which may spread outside the application site. Not known: Burning sensations, Stevens-Johnson syndrome.
Renal and Urinary disorders- Very rare: Worsening renal insufficiency.
","
+- During the first and second trimester: As the safety of ketoprofen in pregnant women has not been evaluated, the use of Ketoprofen during the first and second trimester of pregnancy should be avoided.
+- During the third trimester: During the third trimester of pregnancy, all prostaglandin synthetase inhibitors including ketoprofen may induce cardiopulmonary and renal toxicity in the fetus. At the end of the pregnancy, prolonged bleeding time in both mother and child may occur.
+- Ketoprofen is not recommended in nursing mothers.
+
","
+- The gel should be used with caution in patients with reduced heart, liver or renal function.
+- The gel must not be used with occlusive dressings.
+- The gel must not come into contact with mucous membranes of the eyes.
+- Serious skin reactions, such as Stevens-Johnson Syndrome (SJS), have been reported in association with the use of NSAIDs, including Ketoprofen Gel. Patients should be informed about the signs and symptoms of serious skin manifestations. Treatment should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
+- Treatment should be discontinued immediately upon development of any skin reaction, including cutaneous reactions after co-application of octocrylene -containing products.
+- Protect the treated region with clothing when outdoor, even in the absence of direct sun. This should be done during treatment with the product and for 2 weeks following its discontinuation to avoid the risk of photosensitization.
+- Careful and prolonged hand washing should be carried out after each use of the gel.
+
",,"Overdose is unlikely to be caused by topical administration. If accidentally ingested, the gel may cause systemic adverse effects depending on the amount ingested. However, if they occur, treatment should be symptomatic and supportive in accordance with overdosage of oral anti-inflammatory agents.
",,,"To be stored below 25°C. The tube should be closed after use. Keep all medicines out of the reach of children. Do not use later than the date of expiry. To be dispensed only on the prescription of a registered physician
",11
+647,Ketoprofen (oral & injection),ketoprofen-oral-injection-647,https://medex.com.bd/attachments/gEnvqwamlaMIRsoVuJDMTQeBvtCQmi/ketoprofen-oral-injection-oral-prescribing-information,Drugs for Osteoarthritis,Rheumatic disorders,"The indications of ketoprofen are based on its anti-inflammatory, analgesic and antipyretic properties. Ketoprofen is indicated for symptomatic treatment of:
+
+- Rheumatoid arthritis
+- Degenerative joint diseases
+- Musculoskeletal and joint disorders such as tendinitis, sprain
... Read more
The indications of ketoprofen are based on its anti-inflammatory, analgesic and antipyretic properties. Ketoprofen is indicated for symptomatic treatment of:
+
+- Rheumatoid arthritis
+- Degenerative joint diseases
+- Musculoskeletal and joint disorders such as tendinitis, sprain
+- Pain, regardless of the origin, such as dental pain, headache and primary dysmenorrhea.
+
","Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic actions. In addition to the inhibition of prostaglandin synthesis, it stabilizes lysosomal membranes in vitro and in vivo, inhibits leukotriene synthesis in vitro at high concentrations, and also exhibits antibradykinin activity in vivo. Ketoprofen produces analgesia by inhibiting the synthesis of prostaglandins peripherally and centrally. It has also been suggested that Ketoprofen causes the suppression of prostaglandin synthesis in the CNS (probably in the hypothalamus) leading to its antipyretic effect.
Ketoprofen is rapidly and almost completely absorbed from the GI tract. It is approximately 99% bound to plasma protein, mainly albumin. Following single or multiple oral doses in healthy adults, the elimination half-life of the drug has averaged 1.1-4 hours. It is rapidly and extensively metabolized in the liver, principally via conjugation with glucoronic acid. Following a single oral dose of Ketoprofen in healthy adults, about 50-90% of the drug is excreted in urine and about 1-8% in faeces within 1-5 days ; most urinary excretion occurs within 12-24 hours and most faecal excretion occurs within 24-48 hours. In case of IM injection, peak concentration of approximately 10 mg/L is reached at about 0.5-0.75 hour after a 100 mg dose. The elimination half-life is approximately 1.88 hour.
","Anti-inflammatory dosage: The recommended starting dose is 150 to 300 mg/day in 3 divided doses. Once the maintenance dosage has been established (usually 100 to 200 mg/day), the patient may be tried on a twice daily dose regimen. Alternatively, switching to the once daily form at the same dosage may be considered. The recommended maximum daily dose is 300 mg.
Management of pain and primary dysmenorrhea: The usual recommended dose is 25 to 50 mg, every 6 to 8 hours as necessary. The total daily dose should not exceed 300 mg.
","The oral forms should be taken with fluids, preferably with food.
","Not recommended drug associations Other NSAIDs (including cyclooxygenase-2 selective inhibitors) and high dose salicylates: Increased risk of gastrointestinal ulceration and bleeding. Anticoagulants Increased risk of bleeding.
+
+- Heparin
+- Vitamin K antagonists (such as warfarin)
+- Platelet aggregation inhibitors (such as ticlopidine, clopidogrel)
+- Thrombin inhibitors (such as dabigatran)
+- Direct factor Xa inhibitors (such as apixaban, rivaroxaban, edoxaban)
+
+If coadministration is unavoidable, patient should be closely monitored.
+
+- Lithium: Risk of elevation of lithium plasma levels, sometimes reaching toxic levels due to decreased lithium renal excretion. Where necessary, plasma lithium levels should be closely monitored and the lithium dosage levels adjusted during and after NSAID therapy.
+- Methotrexate at doses greater than 15mg/week: Increased risk of haematologic toxicity of methotrexate, particularly if administered at high doses (>15 mg/week), possibly related to displacement of protein-bound methotrexate and to its decreased renal clearance.
+- Drug associations requiring precautions for use Medicinal products and therapeutic categories that can promote hyperkalemia (i.e. potassium salts, potassium-sparing diuretics, ACE inhibitors and angiotensin II antagonists, NSAIDs, heparins (low molecular-weight or unfractioned), cyclosporin, tacrolimus and trimethoprim): The risk of hyperkalemia can be enhanced when the drugs mentioned above are administered concomitantly.
+- Corticosteroids: increased risk of gastrointestinal ulceration or bleeding.
+- Diuretics: Patients and particularly dehydrated patients taking diuretics are at a greater risk of developing renal failure secondary to a decrease in renal blood flow caused by prostaglandin inhibition. Such patients should be rehydrated before initiating co-administration therapy and renal function monitored when the treatment is started.
+- ACE inhibitors and Angiotensin II Antagonists: In patients with compromised renal function (e.g. dehydrated patients or elderly patients the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclooxygenase may result in further deterioration of renal function, including possible acute renal failure.
+- Nicorandil: In patients concomitantly receiving nicorandil and NSAIDs, there is an increased risk for severe complications such as gastrointestinal ulceration, perforation and hemorrhage.
+- Cardiac glycosides: A pharmacokinetic interaction between ketoprofen and digoxin has not been demonstrated. However, caution is advised, in particular in patients with renal impairment, since NSAIDs may reduce renal function and decrease renal clearance of cardiac glycosides.
+- Cyclosporin: Increased risk of nephrotoxicity.
+- Tacrolimus: Increased risk of nephrotoxicity.
+- Methotrexate at doses lower than 15mg/week: During the first weeks of combination treatment, full blood count should be monitored weekly. If there is any alteration of the renal function or if the patient is elderly, monitoring should be done more frequently.
+- Pentoxifylline: There is an increased risk of bleeding. More frequent clinical monitoring and monitoring of bleeding time is required.
+- Tenofovir: Concomitant administration of tenofovir disoproxil fumarate and NSAIDs may increase the risk of renal failure.
+- Drug associations to be taken into account Antihypertensive agents (beta-blockers, angiotensin converting enzyme inhibitors, diuretics): Risk of decreased antihypertensive potency (inhibition of vasodilator prostaglandins by NSAIDs).
+- Thrombolytics: Increased risk of bleeding. Probenecid: Concomitant administration of probenecid may markedly reduce the plasma clearance of ketoprofen.
+- Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.
+
","Ketoprofen is contraindicated in patients who have a history of hypersensitivity reactions such as asthmatic attacks or other allergic-type reactions to ketoprofen, ASA or other NSAIDs. Severe, rarely fatal, anaphylactic reactions have been reported in such patients. Ketoprofen is also contraindicated in the following cases:
+
+- Severe heart failure
+- Active or history of peptic ulcer/hemorrhage
+- History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy
+- Severe hepatic insufficiency
+- Severe renal insufficiency
+- Third trimester of pregnancy
+- Rectitis or history of proctorrhagia (rectal administration)
+
","
+- Blood and lymphatic system disorders- Rare: haemorrhagic anaemia; Unknown: agranulocytosis, thrombocytopenia, bone marrow failure, hemolytic anemia, leucopenia
+- Immune system disorders- Unknown: anaphylactic reactions (including shock) Psychiatric disorders; Unknown: depression, hallucinations, confusion, mood altered
+- Nervous system disorders- Uncommon: headache, dizziness, somnolence, Rare: paraesthesia; Unknown: aseptic meningitis, convulsions, dysgeusia, vertigo
+- Eye disorders- Rare: vision blurred
+- Ear and labyrinth disorders- Rare: tinnitus
+- Cardiac disorders- Unknown: exacerbation of heart failure, atrial fibrillation
+- Vascular disorders- Unknown: hypertension, vasodilatation, vasculitis (including leukocytoclastic vasculitis)
+- Respiratory, thoracic and mediastinal disorders- Rare: asthma; Unknown: bronchospasm (particularly in patients with known hypersensitivity to ASA and other NSAIDs)
+- Gastrointestinal disorders- Common: dyspepsia, nausea, abdominal pain, vomiting; Uncommon: constipation, diarrhoea, flatulence, gastritis; Rare: stomatitis, peptic ulcer; Unknown: exacerbation of colitis and Crohn’s disease, gastrointestinal haemorrhage and perforation, pancreatitis
+- Hepatobiliary disorders- Rare: hepatitis, transaminases increased
+- Skin and subcutaneous disorders- Uncommon: rash, pruritis; Unknown: photosensitivity reaction, alopecia, urticaria, angioedema, bullous eruption including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis Renal and urinary disorders- Unknown: renal failure acute, tubulointerstitial nephritis, nephritic syndrome, renal function tests abnormal
+- General disorders and administration site conditions- Uncommon: oedema Metabolism and nutritional disorders; Unknown: hyponatremia, hyperkalemia Investigations; Rare: weight increased.
+
","During the first and second trimester: As the safety of ketoprofen in pregnant women has not been evaluated, the use of Ketoprofen during the first and second trimester of pregnancy should be avoided. During the third trimester of pregnancy: Prodenid is contraindicated during the last trimester of pregnancy. Ketoprofen is not recommended in nursing mothers.
","Oral Forms: NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as their condition may be exacerbated. At the start of treatment, renal function must be carefully monitored in patients with heart failure, cirrhosis and nephrosis, in patients receiving diuretic therapy, in patients with chronic renal impairment, particularly if the patient is elderly. In these patients, administration of ketoprofen may induce a reduction in renal blood flow caused by prostaglandin inhibition and lead to renal decomposition.
Caution is required in patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.
Increased risk of atrial fibrillation has been reported in association with the use of NSAIDs.Hyperkalemia may occur, especially in patients with underlying diabetes, renal failure, and/or concomitant treatment with hyperkalemia promoting agents. Potassium levels must be monitored under these circumstances.
As with other NSAIDs, in the presence of an infectious disease, it should be noted that the antiinflammatory, analgesic and the antipyretic properties of ketoprofen may mask the usual signs of infection progression such as fever.
In patients with abnormal liver function tests or with a history of liver disease, transaminase levels should be evaluated periodically, particularly during long-term therapy. Rare cases of jaundice and hepatitis have been described with ketoprofen.
If visual disturbances such a blurred vision occur, treatment should be discontinued. The use of NSAIDs may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of the NSAID should be considered.
","Elderly: It is advisable to reduce the initial dosage and maintain such patients on the minimal effective dose.
Hepatic impairment: These patients should be carefully monitored and kept at the minimal effective daily dosage.
Renal impairment: It is advisable to reduce the initial dosage and maintain such patients on the minimal effective dose.
","Cases of overdose have been reported with doses up to 2.5 g of ketoprofen. In most instances, the symptoms observed have been benign and limited to lethargy, drowsiness, nausea, vomiting and epigastric pain. There are no specific antidotes to ketoprofen overdosages. In cases of suspected massive overdosages, a gastric lavage is recommended and symptomatic and supportive treatment should be instituted to compensate for dehydration, to monitor urinary excretion and to correct acidosis, if present. If renal failure is present, hemodialysis may be useful to remove circulating drug.
",,,"Protect from light. Store below 30°C. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.
",13
+646,Ketoconazole (Tablet),ketoconazole-tablet-646,https://medex.com.bd/attachments/O1anU7Ww9UGDDp4KP0so51jhmx1ubW/ketoconazole-tablet-tablets-prescribing-information,Drugs for subcutaneous and mycoses,Vaginitis,"Treatment of superficial and deep mycoses:
+
+- Infections of the skin, hair and nails by dermatophytes and/or yeasts (dermatomycosis, onychomycosis, perionyxis, pityriasis versicolor, chronic mucocutaneous candidiasis etc.) especially when topical treatment is difficult or not very effective, owing to involvement of large skin surfaces or to lesions affecting deeper dermal layers, nails and hairs
... Read more
Treatment of superficial and deep mycoses:
+
+- Infections of the skin, hair and nails by dermatophytes and/or yeasts (dermatomycosis, onychomycosis, perionyxis, pityriasis versicolor, chronic mucocutaneous candidiasis etc.) especially when topical treatment is difficult or not very effective, owing to involvement of large skin surfaces or to lesions affecting deeper dermal layers, nails and hairs
+- Yeast infection of the mouth (oral thrush, perleche) and the gastrointestinal tract
+- Vaginal candidiasis, especially chronic recurrent cases or cases responding poorly to topcial treatment
+- Systemic mycotic infections such as systemic candidiasis, paracoccidioidomycosis, histoplasmosis, coccidioidomycosis etc.
+
+Maintenance treatment to prevent recurrence in systemic mycotic infections and in chronic mucocutaneous candidiasis.
Prophylactic treatment to prevent mycotic infection in patients with reduced host defenses, e.g., patients with cancer, organ transplant and burns.
","Drugs for subcutaneous and mycoses
","Ketoconazole interferes with biosynthesis of triglycerides and phopholipids by blocking fungal CYP450, thus altering cell membrane permeability in susceptible fungi. It also inhibits other fungal enzymes resulting in the accumulation of toxic concentrations of hydrogen peroxide.
","Vaginal candidiasis: 1 tablet (200 mg) tablet twice daily for 5 days.
All other indications: 1 tablet (200 mg) once daily until at least one week after the symptoms have disappeared and the cultures have become negative.
","Ketoconazole should be taken at meal times for maximal resorption. Because resorption depends on intact gastric activity, the concomitant treatment with agents that reduce gastric secretion (anticholinergic drugs, antacids, H2 blockers) should be avoided. When indicated, such drugs should be taken not earlier than two hours after ketoconazole. If clinical responsiveness is insufficient within the expected time, the dose of ketoconazole may be doubled (400 mg once daily).
","Reduced absorption with antimuscarinics, antacids, H2-blockers, PPIs and sucralfate. Reduced plasma concentrations with rifampicin, isoniazid, efavirenz, nevirapine, phenytoin. May also reduce concentrations of isoniazid and rifampicin. May reduce efficacy of oral contraceptives. May increase serum levels of CYP3A4 substrates e.g. digoxin, oral anticoagulants, sildenafil, tacrolimus.
","Ketoconazole is contraindicated in pregnancy and in patients with acute liver pathology.
","Ketoconazole is very well tolerated. Nausea and itching may occasionally occur. In some patients, an idosyncratic liver reaction may occur (incidence 1:10000).
","Pregnancy category C. There is no adequate and well controlled studies in pregnant women. Ketoconazole Tablets should not be used during pregnancy and lactation.
","In patients with a previous history of liver disease, liver enzyme levels should be monitored during treatment. When patients develop symptoms indicative of liver reaction, such as nausea or fatigue, accompanied with pale faeces, dark urine or jaundice, Ketoconazole therapy should be stopped immediately
",,,"
+- Pityriasis versicolor: 1 to 6 weeks
+- Dermatomycoses: 2 to 8 weeks
+- Onychomycoses: 1 to 12 months
+- Mycoses of hair and scalp: 1 to 2 months
+- Chronic mucocutaneous candidiasis : 1 to 12 months
+- Oral mycoses: 5 to 10 days
+- Systemic candidiasis: 1 to 2 months
+- Paracoccidioidomycosis,histoplasmosis
+- and other systemic mycosis: 1 month to 2 years
+
",,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+1627,Ketoconazole (Shampoo),ketoconazole-shampoo-1627,https://medex.com.bd/attachments/TqVWffL5PgA0hIOYHV07rJ5CEQwsPU/ketoconazole-shampoo-prescribing-information,Drugs for subcutaneous and mycoses,Seborrhoeic dermatitis,"ketoconazole 2% shampoo is indicated for the treatment and prophylaxis of infections in which the yeast Malassezia (previously called Pityrosporum) is involved, such as pityriasis versicolor (localized), seborrhoeic dermatitis and pityriasis capitis (dandruff).
","Drugs for subcutaneous and mycoses
","Ketoconazole 2% shampoo is a broad spectrum imidazole-dioxolane, synthetic antifungal agent which inhibits the in vitro growth of the following common dermatophytes and yeasts by altering the permeability of the cell membrane: dermatophytes: Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton floc-cosum; yeasts: Candida albicans, Malassezia ovale (Pityrosporum ovale) and C. tropicalis; and the organism responsible for tinea versicolor, Malassezia furfur (Pityrosporum orbiculare).
","The affected areas of the skin or the scalp should be washed with ketoconazole 2% shampoo, which should be left on the skin/scalp for 3 to 5 minutes before rinsing.
Treatment:
+
+- Pityriasis versicolor: Once daily for 5 days.
+- Seborrhoeic dermatitis and pityriasis capitis: Twice weekly for 2 to 4 weeks.
+
+Prophylaxis:
+
+- Pityriasis versicolor: Once daily for 3 days during a single treatment course before the summer.
+- Seborrhoeic dermatitis and pityriasis capitis: Once every 1 or 2 weeks
+
",,"No information was found for the Shampoo form of Ketoconazole.
","Contraindicated in patients with known hypersensitivity to ketoconazole.
","Topical treatment with ketoconazole shampoo 2% is generally well tolerated. As with other shampoos, a local burning sensation, itching or contact dermatitis (due to irritation or allergy) may occur on exposed areas. Oily and dry hair have been reported rarely with the use of ketoconazole shampoo 2%.
","Since ketoconazole is not absorbed through the skin after topical application, pregnancy and lactation are not a contraindication for the use of ketoconazole shampoo 2%.
","In patients who have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using ketoconazole shampoo 2%, to prevent any potential rebound effect. Increased hair shedding is often associated with seborrhoeic dermatitis and dandruff, and has been rarely reported with the use of ketoconazole shampoo 2%. Avoid contact with the eyes. If the shampoo should get into the eyes, they should be bathed with water.
",,"Not expected as ketoconazole shampoo 2% is intended for external use only. In the event of accidental ingestion, only supportive measures should be carried out. To avoid aspiration, emesis or gastric lavage should not be performed.
",,,"Store in a cool and dry place, protected from light.
",11
+1628,Ketoconazole (Cream),ketoconazole-cream-1628,https://medex.com.bd/attachments/0TV3mUUiN7qfQs5IyeKbGo9eMXWV13/ketoconazole-cream-prescribing-information,Drugs for subcutaneous and mycoses,Tinea (pityriasis) versicolor,"Ketoconazole 2% cream is used for topical application in the treatment of dermatophyte infections of the skin such as tinea corporis, tinea cruris (dhobie itch), tinea manus and tinea pedis (athlete’s foot) infections due to Trichophyton spp, Microsporon spp and Epidermophyton spp. Ketoconazole ... Read more
Ketoconazole 2% cream is used for topical application in the treatment of dermatophyte infections of the skin such as tinea corporis, tinea cruris (dhobie itch), tinea manus and tinea pedis (athlete’s foot) infections due to Trichophyton spp, Microsporon spp and Epidermophyton spp. Ketoconazole 2% cream is also indicated for the treatment of cutaneous candidosis (including vulvitis), candidal intertrigo (sweat rash), tinea (pityriasis) versicolor and seborrhoeic dermatitis caused by Malassezia (previously called Pityrosporum) spp.
","Drugs for subcutaneous and mycoses
","Ketoconazole interacts with 14-α-sterol demethylase, a cytochrome P-450 enzyme necessary for the conversion of lanosterol to ergosterol. This results in inhibition of ergosterol synthesis and increased fungal cellular permeability due to reduced amounts of ergosterol present in the fungal cell membrane. This metabolic inhibition also results in accumulation of 14α-methyl-3,6-diol, a toxic metabolite. The increase in membrane fluidity is also thought to produce impairment of membrane-bound enzyme systems as components become less closely packed.
","Tinea pedis: Ketoconazole cream should be applied to the affected areas twice daily. The usual duration of treatment for mild infections is 1 week. For more severe or extensive infections (e.g. involving the sole or sides of the feet) treatment should be continued until a few days after all signs and symptoms have disappeared in order to prevent relapse.
For other infections: Ketoconazole cream should be applied to the affected areas once or twice daily, depending on the severity of the infection. The treatment should be continued until a few days after the disappearance of all signs and symptoms. The usual duration of treatment is: tinea versicolor 2-3 weeks, tinea corporis 3-4 weeks. The diagnosis should be reconsidered if no clinical improvement is noted after 4 weeks. General measures in regard to hygiene should be observed to control sources of infection or reinfection. Seborrhoeic dermatitis is a chronic condition and relapse is highly likely.
Administrations: For topical administration only.
",,,"Ketoconazole 2% w/w cream is contra-indicated in patients with known hypersensitivity to Ketoconazole.
","Commonly observed adverse reactions to Ketoconazole cream in clinical trials were skin application site burning sensation, erythema and pruritus. Uncommon adverse reactions are application site bleeding, discomfort, dryness, inflammation, irritation, paraesthesia and reaction; bullous eruption, dermatitis contact, rash, skin exfoliation and sticky skin.
","There are no adequate and well-controlled studies in pregnant or lactating women. To date, no other relevant epidemiological data are available. Data on a limited number of exposed pregnancies indicate no adverse effects of topical Ketoconazole on pregnancy or on the health of the foetus/newborn child. Animal studies have shown reproductive toxicity following oral administration of Ketoconazole. No effects on the breastfed newborn/infant are anticipated.
","Not for ophthalmic use. If a potent topical corticosteroid has been used previously in the treatment of seborrhoeic dermatitis, a recovery period of 2 weeks should be allowed before using Ketoconazole 2% w/w cream, as an increased incidence of steroid induced skin sensitisation has been reported when no recovery period is allowed.
",,"Exaggerated topical application may lead to erythema, oedema and a burning sensation, which will disappear upon discontinuation of the treatment. If accidental ingestion of Ketoconazole 2% w/w cream occurs, no special measures have to be taken.
",,,"Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+645,Ketamine,ketamine-645,https://medex.com.bd/attachments/sxVUNhT2rQNa2eNGgs4FDnZP4GWuEa/ketamine-prescribing-information,General (Intravenous) anesthetics,Induction of anesthesia,"Ketamine is recommended for:
+
+- As the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. Ketamine is best suited for short procedures and it can be used with additional doses, for longer procedures.
+- For the induction of anesthesia prior to the administration of other general anesthetic agents.
+- To supplement low-potency agents, such as nitrous oxide.
+
","General (Intravenous) anesthetics
","Ketamine is a noncompetitive N-methyl-D-aspartate receptor antagonist that blocks glutamate. It has a direct action on the cortex and limbic system. It produces a cataleptic-like state wherein the patient is withdrawn from the surrounding environment.
","Adult:General Anesthesia-
+
+- IV Induction: 1-4.5 mg/kg single dose
+- IM Induction: 6.5-13mg
+- IV Infusion: 1-2mg/kg at 0.5mg/kg/min
+
+
Maintenance: The maintenance dose should be adjusted according to the patient's anesthetic needs and whether an additional anesthetic is employed. Increments of one-half to the full induction dose may be repeated as needed for maintenance of anesthesia.
Rapid sequence Intubation, Induction - 2mg/kg IV
Pediatric:General Anesthesia:
+
+- IV Induction: 1-2 mg/kg IV; range: 4-13 mg/kg
+- IM Induction: 5-10 mg/kg; range: 0.5-4.5 mg/kg
+- Maintenance: 0.01-0.03 mg/kg/min continuous IV infusion
+
+
Maintenance: The maintenance dose should be adjusted according to the patient's anesthetic needs and whether an additional anesthetic is employed. Increments of one-half to the full induction dose may be repeated as needed for maintenance of anesthesia.
","Rate of Administration: It is recommended that ketamine should be administered slowly (over a period of 60 seconds). More rapid administration may result in respiratory depression and enhanced pressor response.
The 100 mg/ml concentration of ketamine should not be injected intravenously without proper dilution. It is recommended the drug be diluted with an equal volume of either Sterile Water for Injection, USP, Normal Saline, or 5% Dextrose in Water.
","Prolonged recovery time with barbiturates or narcotics. May potentiate neuromuscular blocking effects of atracurium and tubocurarine including resp depression with apnoea. May increase risk of bradycardia, hypotension or decreased cardiac output with halogenated anaesthetics. May potentiate CNS depression and risk of resp depression with CNS depressants (e.g. phenothiazines, sedating H1-blockers, skeletal muscle relaxants). May antagonise hypnotic effect of thiopental. May increase risk of HTN with thyroid hormones. May increase risk of hypotension with antihypertensive agents. Reduction in seizure threshold resulting in unpredictable extensor-type seizures when given concurrently with theophylline.
","CV disease including severe HTN; patients with increased intraocular or CSF pressure.
","Emergence reactions (e.g. vivid dreams, hallucinations, confusion, irrational behaviour); increased muscle tone sometimes resembling seizures; temporary HTN and tachycardia, hypotension, bradycardia, arrhythmias, apnoea, laryngospasm, resp depression, diplopia, nystagmus, nausea, vomiting, lacrimation, hypersalivation, raised intraocular and CSF pressure, transient rash and pain at inj site, cystitis.
","Pregnancy: The safe use of ketamine in pregnancy has not been established, and such use is not recommended.
Lactation: Ketamine is likely to be excreted in breast milk and therefore breastfeeding should be discontinued when ketamine is in use.
","Patient with cardiac decompensation, chronic alcoholic or acutely alcohol-intoxicated patients, pre-anaesth elevated CSF pressure, globe injuries, increased intraocular pressure (e.g. glaucoma), neurotic traits or psychiatric illness (e.g. schizophrenia, acute psychosis), acute intermittent porphyria, seizures, hyperthyroidism, pulmonary or upper resp infection, intracranial mass lesions, head injury, or hydrocephalus, hypovolaemia, dehydration, cardiac disease esp coronary artery disease (e.g. CHF, myocardial ischaemia, MI). Pregnancy and lactation.
",,"Symptoms: Resp depression.
Management: Employ supportive ventilation. Mechanical support of respiration is preferred to admin of analeptics.
",,"To prepare a dilute solution containing 1 mg of ketamine per ml, aseptically transfer 10 ml (50 mg per ml vial) to 500 ml of Dextrose Injection, 5% or Sodium Chloride Injection, 0.9% and mix well. The resultant solution will contain 1 mg of ketamine per ml.
","Store between 20-25° C.
",13
+1622,Kanamycin,kanamycin-1622,,Ophthalmic antibacterial drugs,Bacterial ocular infections,"Kanamycin is in a group of drugs called aminoglycosides. It fights bacteria in the body. Kanamycin is used to treat serious infections caused by bacteria. Kanamycin may also be used for other purposes not listed in this medication guide.
","Ophthalmic antibacterial drugs
",,,,,,,,,,,,,,2
+1472,Ivermectin (Topical),ivermectin-topical-1472,https://medex.com.bd/attachments/hkKGDbk6X7nok7Ot6VmPkMUOaMpdu5/ivermectin-topical-prescribing-information,Miscellaneous topical agents,Head lice,"Ivermectin is indicated for topical treatment of head lice infestations in patients 6 months of age and older.
","Miscellaneous topical agents
","Ivermectin, a member of the avermectin class, causes death of parasites, primarily through binding selectively and with high affinity to glutamate-gated chloride channels, which occur in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligandgated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA). The selective activity of compounds of this class is attributable to the fact that some mammals do not have glutamate-gated chloride channels, the avermectins have a low affinity for mammalian ligand-gated chloride channels, and Ivermectin does not readily cross the blood-brain barrier in humans.
","Only for topical use in scalp & scalp hair. It is not for oral, ophthalmic or intravaginal use. Apply the Lotion to dry hair in an amount sufficient (up to 1 tube) to thoroughly coat the hair and scalp. After 10 minutes, rinse off with water. The tube is intended for single use. Discard any unused portion. Contact with eyes should be avoided
","
+- Your hair and scalp must be completely dry before applying Ivermectin Lotion
+- Apply Ivermectin Lotion directly to dry hair and scalp.
+- Completely cover your scalp and hair closest to the scalp first, and then apply outwards towards the ends of your hair.
+- Rub Ivermectin Lotion throughout your hair.
+- It is important to completely cover your entire head so that all lice and eggs are exposed to the lotion. Be sure that each hair is coated from the scalp to the tip.
+- Use sufficient quantities to completely cover hair and scalp.
+- Allow Ivermectin Lotion to stay on your hair and scalp for 10 minutes after it has been applied. Start timing after you have completely covered your hair and scalp with Ivermectin Lotion.
+- After 10 minutes, completely rinse Ivermectin Lotion from your hair and scalp using water only.
+- After application of Ivermectin Lotion, you or anyone who helps you to apply the lotion should wash hands properly
+
",,,"Common side effects are-
+
+- Conjunctivitis
+- Ocular hyperemia
+- Eye irritation
+- Dandruff
+- Dry skin
+- Skin burning sensation etc.
+
","Pregnancy Category C. There are no adequate and well-controlled studies with Ivermectin Lotion in pregnant women. Ivermectin Lotion should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Following oral administration, Ivermectin is excreted in human milk in low concentrations. This has not been evaluated following topical administration. Caution should be exercised when Ivermectin Lotion is administered to a nursing woman.
","Accidental ingestion in pediatric patients may occur administer only under direct adult supervision.
Tips to prevent the spreading of lice:
+
+- Avoid direct head-to-head contact with anyone known to have live, crawling lice.
+- Do not share combs, brushes, hats, scarves, bandannas, ribbons, hair bands, towels, helmets, or other hair-related personal items with anyone else, whether they have lice or not.
+- After finishing treatment with anti-lice medicine, check everyone in your family for lice after one week. Be sure to talk to your healthcare provider about treatments for those who have lice.
+
",,,,,"Keep away from light & wet place. Keep out of reach of children.
",9
+644,Ivermectin (Tablet),ivermectin-tablet-644,https://medex.com.bd/attachments/3aKTB9RP2cp0PEFpvpGQJGjOjhPMEl/ivermectin-tablet-prescribing-information,Anthelmintic,,"Strongyloidiasis of the intestinal tract: Ivermectin is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs ... Read more
Strongyloidiasis of the intestinal tract: Ivermectin is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin.
Onchocerciasis: Ivermectin is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C).
","Anthelmintic
","Ivermectin selectively binds and with high affinity to glutamate-gated chloride ion channels, which occur in invertebrate nerve and muscle cells leading to an increase in the permeability of cell membranes to chloride ions with hyperpolarization of the nerve or muscle cell and, ultimately, death of the parasite.
","For Treatment (If COVIO Positive): 2 Tablets of Ivermectin 6 mg once daily for 5 days. (2+0+0 for 5 days).
For Prophylaxis: Single-dose as mentioned below to be taken on Day 1 & same dose on Day 7.
+
+- Body Weight 15-24 kg: 1 Tablet of Ivermectin 3 mg
+- Body Weight 25-35 kg: 1 Tablet of Ivermectin 6 mg
+- Body Weight 36-50 kg: 1 Tablet of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
+- Body Weight 51-65 kg: 2 Tablets of Ivermectin 6 mg
+- Body Weight 66-79 kg: 2 Tablets of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
+- Body Weight >80 kg: 3 Tablets of Ivermectin 6 mg
+
+
Strongyloidiasis: The recommended dosage of Ivermectin for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg/kg of body weight. Patients should take tablets on an empty stomach with water. In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection.
Dosage Guidelines for Ivermectin for Strongyloidiasis:
+
+- Body Weight (kg) 15-24: Dose 3 mg/kg
+- Body Weight (kg) 25-35: Dose 6 mg/kg
+- Body Weight (kg) 36-50: Dose 9 mg/kg
+- Body Weight (kg) 51-65: Dose 12 mg/kg
+- Body Weight (kg) 66-79: Dose 15 mg/kg
+- Body Weight (kg) >80: Dose 200 mcg/kg
+
+
Onchocerciasis: The recommended dosage of Ivermectin is a single oral dose designed to provide approximately 150 mcg of Ivermectin per kg of body weight on an empty stomach with water, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months.
Dosage Guidelines for Ivermectin for Onchocerciasis:
+
+- Body Weight (kg) 15-25: Dose 3 mg/kg
+- Body Weight (kg) 26-44: Dose 6 mg/kg
+- Body Weight (kg) 45-64: Dose 9 mg/kg
+- Body Weight (kg) 65-84: Dose 12 mg/kg
+- Body Weight (kg) >85: Dose 150 mcg/kg
+
",,"Post-marketing reports of increased INR (International Normalized Ratio) have been rarely reported when ivermectin was co-administered with warfarin.
","It is contraindicated in patients who are hypersensitive to any component of this product.
","Strongyloidiasis: In four clinical studies involving a total of 109 patients given either one or two doses of 170 to 200 mcg/kg of Ivermectin, the following adverse reactions were reported as possibly, probably, or definitely related to Ivermectin.
+
+- Body as a whole: asthenia/fatigue (0.9%), abdominal pain (0.9%)
+- Gastrointestinal: anorexia (0.9%), constipation (0.9%), diarrhea (1.8%), nausea (1.8%), vomiting (0.9%) Nervous System/Psychiatric: dizziness (2.8%), somnolence (0.9%), vertigo (0.9%), tremor (0.9%)
+- Skin: pruritus (2.8%), rash (0.9%), and urticaria (0.9%).
+
+
Onchocerciasis: arthralgia/synovitis (19.3%), axillary lymph node enlargement and tenderness (11.0% and 4.4%, respectively), cervical lymph node enlargement and tenderness (5.3% and 1.2%, respectively), inguinal lymph node enlargement and tenderness (12.6% and 13.9%, respectively), other lymph node enlargement and tenderness (3.0% and 1.9%, respectively), pruritus (27.5%), skin involvement including edema, papular and pustular or frank urticarial rash (22.7%), and fever (22.6%), abnormal sensation in the eyes, eyelid edema, anterior uveitis, conjunctivitis, limbitis, keratitis, and chorioretinitis or choroiditis. These have rarely been severe or associated with loss of vision and have generally resolved without corticosteroid treatment. The following adverse reactions have been reported since the drug was registered overseas: hypotension (mainly orthostatic hypotension), worsening of bronchial asthma, toxic epidermal necrolysis, and Stevens-Johnson syndrome.
","Pregnancy Category C. Ivermectin does not appear to be selectively fetotoxic to the developing fetus. There are, however, no adequate and well-controlled studies in pregnant women. Ivermectin should not be used during pregnancy since safety in pregnancy has not been established.
Nursing Mothers: Ivermectin is excreted in human milk in low concentrations. Treatment of mothers who intend to breast feed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to the newborn
","Historical data have shown that microfilaricidal drugs, such as diethylcarbamazine citrate (DEC-C), might cause cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological reactions in patients with onchocerciasis. These reactions are probably due to allergic and inflammatory responses to the death of microfilariae. Patients treated with Ivermectin for onchocerciasis may experience these reactions in addition to clinical adverse reactions possibly, probably, or definitely related to the drug itself. The treatment of severe Mazzotti reactions has not been subjected to controlled clinical trials. Oral hydration, recumbency, intravenous normal saline, and/or parenteral corticosteroids have been used to treat postural hypotension. Antihistamines and/or aspirin have been used for most mild to moderate cases. After treatment with microfilaricidal drugs, patients with hyperreactive onchodermatitis (sowda) may be more likely than others to experience severe adverse reactions, especially edema and aggravation of onchodermatitis. Rarely, patients with onchocerciasis who are also heavily infected with Loa loa may develop a serious or even fatal encephalopathy either spontaneously or following treatment with an effective microfilaricide. In these patients, the following adverse experiences have also been reported: back pain, conjunctival hemorrhage, dyspnea, urinary and/or fecal incontinence, difficulty in standing/walking, mental status changes, confusion, lethargy, stupor, or coma.
","Pediatric Use: Safety and effectiveness in pediatric patients weighing less than 15 kg have not been established.
Geriatric Use: Clinical studies of Ivermectin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
",,,,"Keep in a dry place, below 30°C. Protect from light. Keep out of the reach of children.
",11
+1152,Ivabradine,ivabradine-1152,https://medex.com.bd/attachments/bivPpeCZ7dnL05WRHeL4mn8TU6jEAR/ivabradine-prescribing-information,Other Anti-anginal & Anti-ischaemic drugs,Chronic stable angina,"Symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm. Ivabradine is indicated:
+
+- In patients unable to tolerate or with a contra-indication to the use of beta-blockers or
+- In combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is > 60 bpm.
+
","Other Anti-anginal & Anti-ischaemic drugs
","Ivabradine is a pure heart rate lowering agent. It acts by selective and specific inhibition of the cardiac pacemaker I f current that controls the spontaneous diastolic depolarization in the sinus node and regulates heart rate. By decreasing heart rate, Ivabradine decreases the cardiac workload and therefore oxygen consumption. Concomitantly, Ivabradine prolongs diastole allowing increased perfusion of coronary arteries and increased oxygen supply to the heart. The cardiac effects are specific to the sinus node with no effect on intra-atrial, atrioventricular or intraventricular conduction times, nor on myocardial contractility or ventricular repolarization.
","Adult: The usual recommended starting dose of Ivabradine is 5 mg twice daily which may be increased after 3-4 weeks of treatment to 7.5 mg twice daily, depending on therapeutic response. Usual dose is 1 tablet in the morning and 1 tablet in the evening during meals. If the heart rate decreases persistently below 50 bpm at rest or if symptoms related to bradycardia, the dose must be adjusted downwards to 2.5 mg twice daily (one half of the 5 mg tablet twice daily). Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist.
Elderly: Consider a lower starting dose (2.5 mg twice daily i.e. one half 5 mg tablet twice daily).
",,"QT wave prolonging medicinal products is not recommended. Cardiovascular QT wave prolonging medicinal products (e.g. quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone). Non cardiovascular QT wave prolonging medicinal products (e.g. pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin). The concomitant use of cardiovascular and non cardiovascular QT wave prolonging medicinal products with ivabradine should be avoided since QT wave prolongation may be exacerbated by heart rate reduction. If the combination appears necessary, close cardiac monitoring is needed.
","History of hypersensitivity to Ivabradine or any of the excipients, resting heart rate below 60 bpm before treatment, cardiogenic shock, acute myocardial infarction, severe hypotension (<90/50 mmHg), severe hepatic insufficiency, sick sinus syndrome, sino-atrial block, heart failure, pacemaker dependent, unstable angina, 3rd degree AV block, combination with strong cytochrome P-450 3A4 inhibitors (such as azole antifungals, macrolide antibiotics, HIV protease inhibitors).
","Visual symptoms, blurred vision, bradycardia, 1st degree AV block, ventricular extrasystoles, headaches, and dizziness.
","Studies in rats have shown no effect on fertility in males and females. There are no or limited amount of data from the use of ivabradine in pregnant women. Therefore, ivabradine is contra indicated during pregnancy. Animal studies indicate that ivabradine is excreted in milk. Therefore, ivabradine is contra-indicated during breast-feeding.
","Mild to moderate hypotension, atrial fibrillation, patients with congenital QT syndrome or treated with QT wave prolonging medicinal products, Moderate hepatic insufficiency, severe renal insufficiency.
","
+- Renal insufficiency: Use with caution in patients with creatinine clearance
+- Hepatic impairment: Use with caution in patients with moderate hepatic impairment; Contraindicated in severe hepatic impairment.
+- Children and adolescents: Not recommended.
+
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+643,Itraconazole,itraconazole-643,https://medex.com.bd/attachments/Td80EdjjncQRIebvHGWCoMvCqki15q/itraconazole-prescribing-information,Drugs for subcutaneous and mycoses,Tinea corporis (ringworm),"Itraconazole is indicated in-
+
+- Tinea corporis, Tinea cruris, Tinea pedis, Tinea manus,
+- Vulvovaginal candidiasis,
+- Fungal keratitis,
+- Pityriasis versicolor,
+- Oropharyngeal candidiasis,
+- Onychomycosis,
+- Histoplasmosis,
+- Systemic Infections: (Aspergillosis, Candidiasis and Cryptococcus when other drugs are effective)
... Read more
Itraconazole is indicated in-
+
+- Tinea corporis, Tinea cruris, Tinea pedis, Tinea manus,
+- Vulvovaginal candidiasis,
+- Fungal keratitis,
+- Pityriasis versicolor,
+- Oropharyngeal candidiasis,
+- Onychomycosis,
+- Histoplasmosis,
+- Systemic Infections: (Aspergillosis, Candidiasis and Cryptococcus when other drugs are effective)
+- Antifungal prophylaxis: To prevent systemic fungal infection in severely neutropenic patients.
+
","Drugs for subcutaneous and mycoses
","Itraconazole is an orally active triazole antifungal agent, having broad-spectrum activity and a favourable pharmacokinetic profile. Itraconazole inhibits cytochrome p-450 dependent enzymes resulting in impairment of the biosynthesis of ergoesterol, a major component of the cell membrane of yeast and fungal cells.
","Tinea corporis, Tinea cruris: 100 mg daily for 2 weeks.
Tinea pedis, Tinea manus: 100 mg daily for 4 weeks.
Vulvovaginal candidiasis: 200 mg twice daily for 1 day or 200 mg daily for 3 days.
Fungal keratitis: 200 mg daily for 3 weeks.
Pityriasis versicolor: 200 mg daily for 1 week.
Oropharyngeal candidiasis: 100 mg daily (200 mg for AIDS patients) for 15 days.
Onychomycosis: 200 mg daily for 3 months; or 200 mg twice daily for 7 days (course), subsequent courses repeated after 21 day interval; fingernails 2 courses and toenails 3 courses.
Histoplasmosis: 200 mg 1-2 times daily.
Systemic Infections: (Aspergillosis, Candidiasis and Cryptococcus when other drugs are effective) 200 mg once daily, increased in invasive or in cryptococcal meningitis to 200 mg twice daily.
Antifungal prophylaxis: To prevent systemic fungal infection in severely neutropenic patients: 100mg daily. Or as directed by the physician.
",,"Itraconazole inhibits the metabolism of Cyclosporine and Warfarin. Interaction with Terfenadine, Phenobarbitone, Midazolam has been reported.
","The drug is contraindicated in patients with a known history of hypersensitivity to it. The drug is also contraindicated in pregnant women and patients with known severe hepatic disease. It is also contraindicated with Rifampicin therapy.
","Nausea, abdominal pain, dyspepsia, constipation, headache, dizziness, raised liver enzymes, hepatitis, cholestatic jaundice, peripheral neuropathy have been reported.
","Not recommended during pregnancy & lactation, unless otherwise indicated by the physician.
","Hepatic enzyme value should be monitored in patients with preexisting hepatic function abnormalities. It should also be done periodically in all patients receiving continuous treatment for more than one month or at any time a patients develops sign and symptoms suggestive liver dysfunction.
","The efficacy and safety of the Itraconazole capsule have not been established in pediatric patients.
","There is no experience of overdosage with itraconazole.
",,,"Store below 30°C, away from light & in a dry place. Keep out of the reach of children.
",12
+642,Isradipine,isradipine-642,,Calcium-channel blockers,Hypertension,"Isradipine is indicated in the management of hypertension. It may be used alone or concurrently with thiazide-type diuretics.
","Calcium-channel blockers
","Isradipine is a dihydropyridine Calcium channel blocker. It prevents Ca++ ions from entering the slow channels or select voltage-sensitive areas of vascular smooth muscle and myocardium during depolarisation, producing a relaxation of coronary vascular smooth muscle and coronary vasodilation.
","Adult: Initially, 2.5 mg bid, increase if necessary after 3-4 wk to 5 mg bid, or 10 mg bid as required.
Elderly: Initially, 1.25 mg bid. Maintenance: 2.5 or 5 mg once daily.
Hepatic Impairment: Initially 1.25 mg bid. Maintenance: 2.5 or 5 mg once daily.
May be taken with or without food.
",,"Concurrent admin with enzyme-inducing drugs (e.g. rifampicin, phenobarbital, carbamazepine) reduced plasma concentrations of isradipine. Increased bioavailability with cimetidine. May increase serum levels with CYP3A4 inhibitors (e.g. macrolides, HIV protease inhibitors, azole antifungals, delavirdine).
","Cardiogenic shock, within 1 mth of MI, unstable angina, treatment of hypertensive crisis.
","Headache, dizziness, palpitations, tachycardia, peripheral oedema, flushing, dyspnoea, abdominal discomfort, rash, pruritus, polyuria, fatigue, malaise.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus
","Patients with CHF, severe aortic stenosis, hypertrophic cardiomyopathy with outflow tract obstruction. Hepatic impairment. Pregnancy and lactation.
",,"Symptoms: Excessive peripheral vasodilation with subsequent marked and prolonged systemic hypotension and tachycardia.
Management: Symptomatic and supportive treatment. Emesis, gastric lavage, admin of activated charcoal followed in 30 min by a saline cathartic. A vasoconstrictor (e.g. epinephrine) may be useful in restoring normotensive state. Refractory hypotension or AV conduction disturbances may be treated with IV Ca salts or glucagon.
",,,"Store below 30° C.
",11
+1816,Ispaghula Husk + Ispaghula Seed + Tinnevelly Senna Pods,ispaghula-husk-ispaghula-seed-tinnevelly-senna-pods-1816,,Bulk-forming laxatives,Constipation,"This is indicated in constipation.
","Bulk-forming laxatives
",,,,,,,,,,,,,,2
+1502,Ispaghula [Psyllium] Husk,ispaghula-psyllium-husk-1502,https://medex.com.bd/attachments/A5B0pWeNr2oJczktPBRXOGc3CvILjI/ispaghula-psyllium-husk-prescribing-information,Bulk-forming laxatives,Constipation,"Psyllium Husk is indicated in-
+
+- Constipation
+- Raised levels of cholesterol
+- Hemorrhoids or piles
+- Irritable bowel syndrome (IBS)
+- Reduces blood glucose level
+
+Psyllium also provides easy bowel movement with smooth stool. So, it is desirable in patients with anal fissures, colon cancer, post anal & rectal surgery and during pregnancy.
","Bulk-forming laxatives
",,"Usual dose: 1 spoonful 1-3 times daily or as per doctor's advice.
Adults and children over 12 years: 1 spoonful with water 2 times daily or as per doctor's advice.
Children 6 to 12 years: ½ to 1 spoonful with water depending on age and size, in the morning and at bedtime or as per doctor's advice.
Children below 6 years: Not recommended except as directed by the physician.
An additional glass of water is helpful after taking this gel.
","
+- Take one spoonful with the provided spoon.
+- Put this husk into an empty glass.
+- Fill glass with water (150 ml or 2/3 of the glass) stir & drink immediately.
+
","No significant interaction has been observed with other medicine.
","Contraindicated in patients with gastrointestinal tract obstruction or threatening obstruction of the bowel.
","Common side effects are flatulence, abdominal distension, gastro-intestinal obstruction.
",,,,,,,"Store in a cool and dry place. Keep out of reach of children.
",8
+1844,Lanthanum Carbonate,lanthanum-carbonate-1844,https://medex.com.bd/attachments/XAlOzbWo1Wbex1lL2NBpDezNrZGW09/lanthanum-carbonate-prescribing-information,Drugs used in chronic kidney dialysis,End-stage renal failure,"Lanthanum Carbonate is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD).
","Drugs used in chronic kidney dialysis
","Lanthanum Carbonate is a phosphate binder that reduces absorption of phosphate by forming insoluble Lanthanum phosphate complexes that pass through the Gl tract unabsorbed. Both serum phosphate and calcium phosphate product are reduced as a consequence of the reduced dietary phosphate absorption.
In vitro studies have shown that Lanthanum binds phosphate in the physiologically relevant pH range of 3 to 7. In simulated gastric fluid, Lanthanum binds approximately 97% of the available phosphate at pH 3-5 and 67% at pH 7, when Lanthanum is present in a two-fold molar excess to phosphate. Bile acids have not been shown to affect the phosphate binding affinity of Lanthanum. In order to bind dietary phosphate, Lanthanum Carbonate must be administered with or immediately after meals.
","The recommended initial total daily dose of Lanthanum Carbonate is 1,500 mg in divided doses. Titrate every 2 to 3 weeks based on serum phosphate level. Take Lanthanum Carbonate with or immediately after meals.
Lanthanum Carbonate Chewable Tablets: Do not swallow tablets whole. Chew or crush tablet completely before swallowing.
",,"Drugs Binding to Antacids: There is a potential for Lanthanum Carbonate to interact with compounds which bind to cationic antacids (i.e., aluminum-,magnesium-, or calcium-based); therefore, do not administer such compounds within 2 hours of dosing with Lanthanum Carbonate.
Quinolone Antibiotics: Co-administration of Lanthanum Carbonate with quinolone antibiotics may reduce the extent of their absorption. The bioavailability of oral ciprofloxacin was decreased by approximately 50% when taken with Lanthanum Carbonate in a single-dose study in healthy volunteers. Administer oral quinolone antibiotics at least 1 hour before or 4 hours after Lanthanum Carbonate. When oral quinolones are given for short courses, consider eliminating the doses of Lanthanum Carbonate that would normally be scheduled near the time of quinolone intake to improve quinolone absorption.
Levothyroxine: the bioavailability of levothyroxine was decreased by approximately 40% when taken together with Lanthanum Carbonate. Administer thyroid hormone replacement therapy at least 2 hours before or 2 hours after dosing with Lanthanum Carbonate and monitor thyroid stimulating hormone (TSH).
","Contraindicated in bowel obstruction, including ileus and fecal impaction.
","The most common adverse reactions for Lanthanum Carbonate were gastrointestinal events, such as nausea, vomiting, and abdominal pain and they generally abated over time with continued dosing. The following adverse reactions have been identified during post-approval use of Lanthanum Carbonate constipation, dyspepsia, allergic skin reactions, and tooth injury while chewing the tablet.
","Pregnancy: Available data from case reports with use of Lanthanum Carbonate in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Use a non-Lanthanum containing phosphate binder in a pregnant woman.
Lactation: There are no data on the presence of Lanthanum Carbonate from Lanthanum Carbonate in human milk, the effects on the breastfed infant, or the effects on milk production. Use a non-Lanthanum containing phosphate binder in a lactating woman.
","Gastrointestinal Adverse Effects: Serious cases of gastrointestinal obstruction, ileus, subileus, gastrointestinal perforation, and fecal impaction have been reported in patients taking Lanthanum, some requiring surgery or hospitalization. During treatment with Lanthanum Carbonate, physicians and patients should remain vigilant for signs and symptoms of gastrointestinal disorders, especially constipation and abdominal pain/distention, which may indicate bowel obstruction, ileus, or subileus. Treatment with Lanthanum Carbonate should be re-evaluated in patients who develop severe constipation or other severe gastrointestinal signs and symptoms. Advise patients who are prescribed Lanthanum Carbonate Chewable Tablets to chew the tablet completely and not to swallow them whole. Serious gastrointestinal complications have been reported in association with unchewed or incompletely chewed tablets.
","Pediatric Use: The safety and efficacy of Lanthanum Carbonate in pediatric patients have not been established. The use of Lanthanum Carbonate in this population is not recommended.
Geriatric Use: Of the total number of patients in clinical studies of Lanthanum Carbonate, 32% (538) were >65 years of age, while 9.3% (159) were >75 years of age. No overall differences in safety or effectiveness were observed between patients >65 years of age and younger patients.
","The symptoms associated with overdose are adverse reactions such as headache, nausea and vomiting. In clinical trials in healthy adults, gastrointestinal (Gl) symptoms were reported with daily doses up to 6,000 mg/day of Lanthanum Carbonate administered with food.
",,,"Store in a cool (below 30° C) and dry place, away from light. Keep out of the reach of children.
",12
+76,Lansoprazole + Amoxicillin + Clarithromycin,lansoprazole-amoxicillin-clarithromycin-76,https://medex.com.bd/attachments/NzZxGVd8OE3eoO7YuRXsJ68MTbvK9W/lansoprazole-amoxicillin-clarithromycin-prescribing-information,Anti H. pylori drugs,Gastric ulcer,"This is indicated for the eradication of H. pylori in active chronic gastric, duodenal and gastric ulcers.
","Anti H. pylori drugs
","Lansoprazole is a proton-pump inhibitor which inhibits the stomach's production of gastric acids. Amoxicillin is a penicillin antibiotic. It acts by inhibiting the synthesis of bacterial cell walls.lt inhibits cross-linkage between the linear peptidoglycan polymer chains that make up a major component of the cell walls of both Gram-positive and Gram-negative bacteria. Clarithromycin is a macrolide antibiotic.It prevents bacteria from growing by interfering with their protein synthesis. It binds to the subunit 50S of the bacterial ribosome and thus inhibits the translation of peptides
","Adult dose: One strip twice daily for 7-14 days or as per the physician's advice.
Geriatric use: Elderly patients may suffer from asymptomatic renal and hepatic dysfunction. Care should be taken when administering to these patients.
",,"
+- Lansoprazole is metabolized through the cytochrome P450 system,specially through the CYP3A and CYP2C19 isozymes.Studies in healthy subjects have shown that Lansoprazole does not have clinically significant interactions with other drugs metabolized by the cytochrome P450 system, such as warfarin, antipyrine, indomethacin, ibuprofen, phenytoin, propranolol, prednisolone, diazepam, clarithromycin or terfenadine.
+- Clarithromycin use in patients who are receiving theophylline may be associated with increase of serum theophylline concentrations.
+- There have been reports of interactions of erythromycin and/or clarithromycin with carbamazepine, cyclosporine, tacrolimus, hexobarbital, phenytoin, alfetanil, disopyramide, lovastatin, bromocriptine, valproate, terfenadine, cisapride, pimozide & astemizole.
+
","This is contraindicated in patients with known hypersensitivity to any of its component.
","Adverse reactions which were reported as possibly or probably related to treatment (>3%) in clinical trials when all three components of this therapy were given concomitantly are listed below and divided by body systems. Digestive system: Nausea, vomiting, diarrhea, dark stools, dry mouth, glossitis, oral moniliasis, stomatitis, tongue discoloration. Musculoskeletal System: myalgia. Nervous System: confusion, headache, dizziness; Skin: skin reactions. Urogenital System: vaginitis,vaginal moniliasis.
","There were no adequate and well-controlled studies in pregnant women. This should be used during pregnancy only if the potential benefit justifies the potential risk of the mother. Amoxicillin is excreted in human milk in very small amounts. Because of the potential for serious adverse reactions in nursing infants. A decision should be made whether to discontinue nursing or to discontinue the drug therapy, taking into account the importance of the therapy to the mother.
","Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on Amoxicillin therapy. These reactions are more appropriate to occur in individuals with a history of penicillin hypersensitivity. Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate.
",,,,,"Store in a cool and dry place, protected from light.
",10
+663,Lansoprazole,lansoprazole-663,https://medex.com.bd/attachments/CQ1y2KpPbg9w6Qb6lfOXdNL1d4ffJb/lansoprazole-prescribing-information,Proton Pump Inhibitor,Peptic ulcer disease,"Lansoprazole is indicated for:
+
+- Short term treatment of active duodenal ulcer
+- Maintenance of healed duodenal ulcers
+- Short term treatment of active benign gastric ulcers
+- Short term treatment of active erosive esophagitis
+- Maintenance of healing of erosive esophagitis
... Read more
Lansoprazole is indicated for:
+
+- Short term treatment of active duodenal ulcer
+- Maintenance of healed duodenal ulcers
+- Short term treatment of active benign gastric ulcers
+- Short term treatment of active erosive esophagitis
+- Maintenance of healing of erosive esophagitis
+- Pathological hypersecretory conditions including Zollinger- Ellison Syndrome
+- H. pylori eradication to reduce the risk of duodenal ulcer recurrence
+
","Proton Pump Inhibitor
","Lansoprazole is a substituted benzimidazole, and is also known as PPI due to its property to block the final step of acid secretion by inhibiting H+/K+ ATPase enzyme system in gastric parietal cell. Both basal and stimulated acid are inhibited.
","Benign gastric ulcer: 30 mg daily in the morning for 8 weeks.
Duodenal ulcer: 30 mg daily in the morning for 4 weeks; maintenance 15 mg.
NSAID-associated duodenal or gastric ulcer: 15-30 mg daily for 4 weeks, followed by a further 4 weeks if not fully healed.
Zollinger-Ellison syndrome (and other hypersecretory conditions): Initially 60 mg once daily adjusted according to response; daily doses of 120 mg or more is given in two divided doses.
Gastroesophageal reflux disease: 30 mg daily in the morning for 4 weeks, followed by a further 4 weeks if not fully healed; maintenance 15-30 mg daily.
Acid-related dyspepsia: 15-30 mg daily in the morning for 2-4 weeks.
",,"Lansoprazole appears to be a selective inhibitor of the cytochrome P-450 monooxygenase system; there may be an effect on hepatic clearance, but there have been no reports to date of clinically relevant interactions. There is some uncertainty over the effect of Lansoprazole on the oral combined contraceptive pill. Further assessment is currently underway. Physiological changes similar to those found with Omeprazole are likely to take place because of the reduction in gastric acid, which is likely to influence the bacterial colonization of the stomach and duodenum and also vitamin B12 absorption.
","Lansoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.
","Severe or irreversible adverse effects: The possible induction of carcinoid tumors by profound acid suppression, and a rise in serum gastrin may occur. There is a rise in serum gastrin levels in the first 3 months of treatment, which are then maintained though at a lower level than those found in pernicious anaemia. Long term treatment with a proton pump inhibitor in patients with Helicobacter pylori infection may accelerate the development of atrophic gastritis.
Symptomatic adverse effect: Dose dependent diarrhoea occurs with an incidence of about 4% at 30 mg per day, rising to 8% at 60 mg per day. Headache occurs in 2-3% of treated patients
","Lansoprazole should be avoided in pregnancy unless there are compelling reasons.
","Gastric malignancy should be ruled out. Hepatic impairment. Pregnancy and lactation.
","Neonates:There is no relevant human data. The drug is not recommended for use with neonates.
Children: The youngest person to have received Lansoprazole in clinical trials was 13 years old.
The Elderly: No problems have been encoun- tered in clinical use and there has been no increase in adverse drug reaction in the elderly.
",,,,"Store at 25° C.
",11
+656,Lamotrigine,lamotrigine-656,https://medex.com.bd/attachments/fMeSkew5b0oQpHiwSP9VP2LFn3KdC6/lamotrigine-prescribing-information,Primary anti-epileptic drugs,Unipolar and bipolar depression,"Lamotrigine is indicated for:
Epilepsy-combination therapy in patients aged 2 years and older:
+
+- partial-onset seizures
+- primary generalized tonic-clonic seizures
+- generalized seizures of Lennox-Gastaut syndrome
+
+Epilepsy-monotherapy in patients aged 16 years and older.
Adults with Bipolar Disorder.
","Primary anti-epileptic drugs
","The exact mechanism of action of lamotrigine is not fully elucidated, as it may exert cellular activities that contribute to its efficacy in a range of conditions. Although chemically unrelated, lamotrigine actions resemble those of phenytoin and carbamazepine, inhibiting voltage-sensitive sodium channels, stabilizing neuronal membranes, thereby modulating the release of presynaptic excitatory neurotransmitters.
Lamotrigine likely acts by inhibiting sodium currents by selective binding to the inactive sodium channel, suppressing the release of the excitatory amino acid, glutamate. The mechanism of action of lamotrigine in reducing anticonvulsant activity is likely the same in managing bipolar disorder. Studies on lamotrigine have identified its binding to sodium channels in a fashion similar to local anesthetics, which could explain the demonstrated clinical benefit of lamotrigine in some neuropathic pain states.
Lamotrigine displays binding properties to several different receptors. In laboratory binding assays, it demonstrates weak inhibitory effect on the serotonin 5-HT3 receptor. Lamotrigine also weakly binds to Adenosine A1/A2 receptors, α1/α2/β adrenergic receptors, dopamine D1/D2 receptors, GABA A/B receptors, histamine H1 receptors, κ-opioid receptor (KOR), mACh receptors and serotonin 5-HT2 receptors with an IC50>100 µM. Weak inhibitory effects were observed at sigma opioid receptors. An in vivo study revealed evidence that lamotrigine inhibits Cav2.3 (R-type) calcium currents, which may also contribute to its anticonvulsant effects.
","Epilepsy-
Table-1: Escalation Regimen for Lamotrigine in Patients Older than 12 Years with Epilepsy
+Weeks 1 & 2:
+
+- In patients not taking Carbamazepine, Phenytoin, Phenobarbital, Primidone or Valproate: 25 mg every day
+- In patients taking Valproate: 25 mg every other day
+- In patients taking Carbamazepine, Phenytoin, Phenobarbital or Primidone and not taking Valproate: 50 mg/day
+
+Weeks 3 & 4:
+
+- In patients not taking Carbamazepine, Phenytoin, Phenobarbital, Primidone or Valproate: 50 mg/day
+- In patients taking Valproate: 25 mg every day
+- In patients taking Carbamazepine, Phenytoin, Phenobarbital or Primidone and not taking Valproate: 100 mg/day (in 2 divided doses)
+
+Week 5 onward to maintenance:
+
+- In patients not taking Carbamazepine, Phenytoin, Phenobarbital, Primidone or Valproate: Increase by 50 mg/day every 1 to 2 weeks
+- In patients taking Valproate: Increase by 25 to 50 mg/day every 1 to 2 weeks
+- In patients taking Carbamazepine, Phenytoin, Phenobarbital or Primidone and not taking Valproate: Increase by 100 mg/day every 1 to 2 weeks
+
+Usual maintenance dose:
+
+- In patients not taking Carbamazepine, Phenytoin, Phenobarbital, Primidone or Valproate: 225 to 375 mg/day (in 2 divided doses)
+- In patients taking Valproate: 100 to 200 mg/day with Valproate alone 100 to 400 mg/day with Valproate and other drugs that induce glucuronidation (in 1 or 2 divided doses)
+- In patients taking Carbamazepine, Phenytoin, Phenobarbital or Primidone and not taking Valproate: 300 to 500 mg/day (in 2 divided doses)
+
+
Table-2: Escalation Regimen for Lamotrigine in Patients Aged 2 to 12 Years with EpilepsyWeeks 1 & 2:
+
+- In patients not taking Carbamazepine, Phenytoin, Phenobarbital, Primidone or Valproate: 0.3 mg/kg/day in 1 or 2 divided doses
+- In patients taking Valproate: 0.15 mg/kg/day in 1 or 2 divided doses
+- In patients taking Carbamazepine, Phenytoin, Phenobarbital or Primidone and not taking Valproate: 0.6 mg/kg/day (in 2 divided doses)
+
+Weeks 3 & 4:
In patients not taking Carbamazepine, Phenytoin, Phenobarbital, Primidone or Valproate: 0.6 mg/kg/day (in 2 divided doses)
+
+- In patients taking Valproate: 0.3 mg/kg/day in 1 or 2 divided doses
+- In patients taking Carbamazepine, Phenytoin, Phenobarbital or Primidone and not taking Valproate: 1.2 mg/kg/day (in 2 divided doses)
+
+Week 5 onward to maintenance:
+
+- In patients not taking Carbamazepine, Phenytoin, Phenobarbital, Primidone or Valproate: The dose should be increased every 1 to 2 weeks as follows-calculate 0.6 mg/kg/day
+- In patients taking Valproate: The dose should be increased every 1 to 2 weeks as follows-calculate 0.3 mg/kg/day
+- In patients taking Carbamazepine, Phenytoin, Phenobarbital or Primidone and not taking Valproate: The dose should be increased every 1 to 2 weeks as follows-calculate 1.2 mg/kg/day
+
+Usual maintenance dose:
+
+- In patients not taking Carbamazepine, Phenytoin, Phenobarbital, Primidone or Valproate: 4.5 to 7.5 mg/kg/day (maximum 300 mg/day in 2 divided doses)
+- In patients taking Valproate: 1 to 3 mg/kg/day with Valproate alone 1 to 5 mg/kg/day (maximum 200 mg/day in 1 or 2 divided doses)
+- In patients taking Carbamazepine, Phenytoin, Phenobarbital or Primidone and not taking Valproate: 5 to 15 mg/kg/day (maximum 400 mg/day in 2 divided doses)
+
+
Table-3: The Initial Weight-Based Dosing Guide for Patients Aged 2 to 12 Years Taking Valproate (Weeks 1 to 4) with EpilepsyWeeks 1 & 2:
+
+- If the patients weight is 6.7 kg to 14 kg: 2 mg every other day
+- If the patients weight is 14.1 kg to 27 kg: 2 mg every day
+- If the patients weight is 27.1 kg to 34 kg: 4 mg every day
+- If the patients weight is 34.1 kg to 40 kg: 5 mg every day
+
+Weeks 3 & 4:
+
+- If the patients weight is 6.7 kg to 14 kg: 2 mg every day
+- If the patients weight is 14.1 kg to 27 kg: 4 mg every day
+- If the patients weight is 27.1 kg to 34 kg: 8 mg every day
+- If the patients weight is 34.1 kg to 40 kg: 10 mg every day
+
+
Bipolar disorder-
Table-4: Escalation Regimen for Lamotrigine in Adults with Bipolar DisorderWeeks 1 & 2:
+
+- In patients not taking Carbamazepine, Phenytoin, Phenobarbital, Primidone or Valproate: 25 mg daily
+- In patients taking Valproate: 25 mg every other day
+- In patients taking Carbamazepine, Phenytoin, Phenobarbital or Primidone and not taking Valproate: 50 mg daily
+
+Weeks 3 & 4:
+
+- In patients not taking Carbamazepine, Phenytoin, Phenobarbital, Primidone or Valproate: 50 mg daily
+- In patients taking Valproate: 25 mg daily
+- In patients taking Carbamazepine, Phenytoin, Phenobarbital or Primidone and not taking Valproate: 100 mg daily (in divided doses)
+
+Week 5:
+
+- In patients not taking Carbamazepine, Phenytoin, Phenobarbital, Primidone or Valproate: 100 mg daily
+- In patients taking Valproate: 50 mg daily
+- In patients taking Carbamazepine, Phenytoin, Phenobarbital or Primidone and not taking Valproate: 200 mg daily (in divided doses)
+
+Week 6:
+
+- In patients not taking Carbamazepine, Phenytoin, Phenobarbital, Primidone or Valproate: 200 mg daily
+- In patients taking Valproate: 100 mg daily
+- In patients taking Carbamazepine, Phenytoin, Phenobarbital or Primidone and not taking Valproate: 300 mg daily (in divided doses)
+
+Week 7:
+
+- In patients not taking Carbamazepine, Phenytoin, Phenobarbital, Primidone or Valproate: 200 mg daily
+- In patients taking Valproate: 100 mg daily
+- In patients taking Carbamazepine, Phenytoin, Phenobarbital or Primidone and not taking Valproate: up to 400 mg daily (in divided doses)
+
",,"Lamotrigine interacts with Oral contraceptives, Atazanavir/ritonavir, Carbamazepine, Levetiracetam, Lithium, Lopinavir/ritonavir , Olanzapine, Phenobarbital/primidone , Phenytoin, Pregabalin etc.
",,"Common side effects of Lamotrigine include-dizziness, tremor, headache, rash, blurred vision, fever, lack of coordination, abdominal pain, infections, sleepiness, back pain, vomiting, diarrhea, tiredness, insomnia, dry mouth, stuffy nose, sore throat.
","Pregnancy Category C. Lamotrigine is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Lamotrigine, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
","Serious skin rashes, Blood Dyscrasias, Suicidal Behavior, Aseptic Meningitis can occur in both adult and pediatric population.
","Pediatric Use:
+
+- Epilepsy: Safety and effectiveness of Lamotrigine used as adjunctive treatment for partial onset seizures were not demonstrated in very young pediatric patient's aged 1 to 24 months.
+- Bipolar Disorder: Safety and effectiveness of Lamotrigine for the maintenance treatment of bipolar disorder were not established in pediatric patient's aged 10 to 17 years.
+
","Overdose has resulted in ataxia, nystagmus, seizures (including tonic-clonic seizures), decreased level of consciousness, coma, and intraventricular conduction delay.
",,,"Store below 30°C. Protect from light and moisture. Keep out of the reach of children.
",11
+662,Lamivudine + Zidovudine + Nevirapine,lamivudine-zidovudine-nevirapine-662,https://medex.com.bd/attachments/cI92dnnCNMthQMfp40QjIcqWyTk18N/lamivudine-zidovudine-nevirapine-prescribing-information,Drugs for HIV / Anti-retroviral drugs,HIV infection,"A fixed dose combination of Lamivudine, Zidovudine and Nevirapine is recommended for HIV-1 infected patients who are able to tolerate maintenance therapy with Nevirapine 200 mg twice daily. All three drugs are to be administered twice daily and each tablet contains half of the daily dose for each component ... Read more
A fixed dose combination of Lamivudine, Zidovudine and Nevirapine is recommended for HIV-1 infected patients who are able to tolerate maintenance therapy with Nevirapine 200 mg twice daily. All three drugs are to be administered twice daily and each tablet contains half of the daily dose for each component. Twice daily formulation in single tablet for three drugs is convenient for patients to take, ensuring higher rate of compliance.
","Drugs for HIV / Anti-retroviral drugs
","Lamivudine, Zidovudine & Nevirapine synergistically reduce the viral resistance and inhibit reverse transcriptase via DNA chain termination.
Lamivudine: Intracellularly, Lamivudine is phosphorylated to its active 5’-triphosphate metabolite, Lamivudine triphosphate (L-TP). The principal mode of action of L-TP is inhibition of reverse transcription (RT) via DNA chain termination after incorporation of the nucleoside analogue. Following oral administration, Lamivudine is rapidly absorbed and extensively distributed. Binding to plasma protein is low.
Zidovudine: Intracellularly, Zidovudine is phosphorylated to its active 5’-triphosphate metabolite, Zidovudine triphosphate (ZDV-TP). The principal mode of action of ZDV-TP is inhibition of RT via DNA chain termination after incorporation of the nucleoside analogue. Following oral administration, Zidovudine is rapidly absorbed and extensively distributed. Binding to plasma protein is low. Zidovudine is eliminated primarily by hepatic metabolism.
Nevirapine: Nevirapine binds directly to reverse transcriptase (RT) and blocks the RNA-dependent and DNA-dependent DNA polymerase activities by causing a disruption of the enzyme's catalytic site. The activity of nevirapine does not compete with template or nucleoside triphosphates.
","Adult dose: One tablet twice daily. This fixed dose combination is not recommended for patients who have not been on initial lower dose of Nevirapine 200 mg once daily for 2 weeks and /or have not tolerated this dose. After successful therapy with low dose Nevirapine for two weeks, patients can be switched over to 200 mg bid dose provided they have not demonstrated any hypersensitivity reaction (rash, abnormal liver function tests) during their initial exposure to Nevirapine. Monitoring of patients for their liver function tests etc. is desirable prior to initiating therapy with Nevirapine and monitoring at frequent intervals once therapy with fixed dose combination is continued.
Dosage adjustment:
+
+- Lamivudine: For patients with low body weight (<50 kg) where dosage adjustment may be required, it is preferable not to use this fixed dose combination.
+- Zidovudine: Because it is a fixed dose combination, this should not be prescribed for patients requiring dosage adjustment such as those with reduced renal function (creatinine clearance 50 ml/min) or those experiencing dose imiting adverse events.
+- Nevirapine: For patients who experience severe rash or rash with constitutional complaints during the initial low dose Nevirapine phase of 14 days with once daily dose of 200 mg; neither, dose should be increased to twice daily nor they should receive triple fixed dose combination until the rash is resolved. Similarly for patients with abnormal liver function tests, Nevirapine therapy should be stopped till liver function return to normal and careful restart is advisable after extended observation. In event of recurrence, Nevirapine therapy can not be restarted.
+- For patients where Nevirapine therapy has to be restarted after an interruption, daily dose of Nevirapine 200 mg for 14 days should be followed with twice daily dose in absence of any hypersensitivity reaction. Studies have not been documented to suggest dosage of Nevirapine in patients with hepatic dysfunction, renal insufficiency or undergoing dialysis.
+
",,"Zidovudine: acyclovir and valacyclovir may increase CNS depression. Increased risk of haematologic toxicity with ganciclovir, valganciclovir, dapsone, doxorubicin, vincristine and vinblastine. Doxorubicin may reduce phophorylation; fluconazole may increase levels/effects; increased risk of hepatic decompensation or haematologic toxicities with interferon and ribavirin (also increases risk of pancreatitis and lactic acidosis). Methadone may increase effects/levels. Increased risk of myalgia, malaise and/or fever, maculopapular rash and effects/levels with probenecid. Stavudine may decrease antiviral activity; valproic acid may increase plasma levels (AUC increased by 80%).
Lamivudine: Increased risk of hepatic decompensation or haematologic toxicities with interferon and ribavirin (also increases risk of mitochondrial toxicity, pancreatitis and lactic acidosis). Ganciclovir and valganciclovir may increase effects and toxicity; sulfamethoxazole/ trimethoprim may increase AUC and decrease clearance (increasing levels and effects).
","History of hypersensitivity to Lamivudine, Zidovudine, Nevirapine and to any of the excipients available in formulation. Not to be used as initial therapy because initial therapy requires 200 mg once daily of Nevirapine whereas fixed dose combination allows for 200 mg twice daily of Nevirapine.
","Lamivudine: Pancreatitis, paresthesia, peripheral neuropathy, cough, dizziness, fatigue, gastrointestinal problems, headache, insomnia, anaemia, neutropenia, drug induced skin rash, hair loss.
Zidovudine: Headache (which may be severe, has been reported in up to 63% of patients receiving Zidovudine and asthenia has been reported in 9-69%), malaise and fatigue, fever or chills, nausea (61% cases), diaphoresis, dyspnoea, rash and taste perversion have been reported. Skin rashes and myalgia has been reported in patients receiving Zidovudine. Myopathy and myositis with pathologic changes similar to that produced by HIV infection, have been associated with prolonged use of Zidovudine. The major adverse effect is bone marrow toxicity resulting in severe anaemia and/or neutropenia. Patients with low serum folate or vitamin B12 concentrations may be at increased risk for developing bone marrow toxicity during Zidovudine therapy. There also are limited data suggesting that bone marrow of patients with fulminant acquired immunodeficiency syndrome (AIDS) may be more sensitive to Zidovudine induced toxicity than that of patients with less advanced disease (eg, AIDS related complex). Anaemia and granulocytopenia usually resolve when Zidovudine is discontinued or when dosage is decreased. Lactic acidosis (in the absence of hypoxaemia) and severe hepatomegaly with steatosis, including some fatalities, have been reported in patients receiving Zidovudine.
Nevirapine: More frequent incidences are skin rash, diarrhoea, gastrointestinal problems, headache, nausea and stomach pain. Incidence of less frequents are aphthous stomatitis, fever, hepatitis and Stevens Johnson syndrome.
","Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","For the following conditions, assess risk to patient and take action as needed, chronic hepatitis B, hepatomegaly with steatosis, lactic acidosis, liver function impairment, severe renal function impairment, peripheral neuropathy.
",,,,,"Should be stored in cool and dry place
",10
+655,Lamivudine + Zidovudine,lamivudine-zidovudine-655,https://medex.com.bd/attachments/4a56RJQNj8fOdTlvma0idtoOHWoxzv/lamivudine-zidovudine-prescribing-information,Drugs for HIV / Anti-retroviral drugs,HIV infection,"Lamivudine and zidovudine tablets, a combination of 2 nucleoside analogue reverse transcriptase inhibitors, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection
","Drugs for HIV / Anti-retroviral drugs
","Lamivudine and Zidovudine are synthetic nucleoside analogues with activity against human immunodeficiency virus (HIV).
Lamivudine: Intracellularly, Lamivudine is phosphorylated to its active 5’-triphosphate metabolite, Lamivudine triphosphate (L-TP). The principal mode of action of L-TP is inhibition of reverse transcription (RT) via DNA chain termination after incorporation of the nucleoside analogue. Following oral administration, Lamivudine is rapidly absorbed and extensively distributed. Binding to plasma protein is low.
Zidovudine: Intracellularly, Zidovudine is phosphorylated to its active 5’-triphosphate metabolite, Zidovudine triphosphate (ZDV-TP). The principal mode of action of ZDV-TP is inhibition of RT via DNA chain termination after incorporation of the nucleoside analogue. Following oral administration, Zidovudine is rapidly absorbed and extensively distributed. Binding to plasma protein is low. Zidovudine is eliminated primarily by hepatic metabolism.
","Recommended Dosage for Adults and Adolescents: The recommended dosage of lamivudine and zidovudine tablets in HIV-1-infected adults and adolescents weighing greater than or equal to 30 kg is 1 tablet (containing 150 mg of lamivudine and 300 mg of zidovudine) taken orally twice daily.
Recommended Dosage for Pediatric Patients: The recommended dosage of lamivudine and zidovudine tablets for pediatric patients who weigh greater than or equal to 30 kg and for whom a solid oral dosage form is appropriate is 1 tablet administered orally twice daily on an empty stomach. Before prescribing lamivudine and zidovudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a lamivudine and zidovudine tablet, the liquid oral formulations should be prescribed.
Not Recommended Due to Lack of Dosage Adjustment Because lamivudine and zidovudine tablets are a fixed-dose formulation and cannot be dose adjusted, lamivudine and zidovudine tablets are not recommended for:
+
+- Pediatric patients weighing less than 30 kg
+- Patients with creatinine clearance less than 50 mL per minute
+- Patients with hepatic impairment
+- Patients experiencing dose-limiting adverse reactions. Liquid and solid oral formulations of the individual components of lamivudine and zidovudine tablets are available for these populations.
+
",,"Cross-resistance may develop when given with emtricitabine. Exacerbation of anaemia with concomitant use of zidovudine with ribavirin. Increased adverse effects to zidovudine with nephrotoxic or myelosuppressive drugs (e.g. systemic pentamide, dapsone, pyrimethamine, co-trimoxazole, amphotericin, flucytosine, ganciclovir, interferon, vincristine, vinblastine, doxorubicin). Lamivudine and zalcitabine may inhibit the intracellular phosphorylation of one another. Antagonistic effect when zidovudine is used concomitantly with stavudine or doxorubicin.
","This is contraindicated in patients with previously demonstrated clinically significant hypersensitivity to any of the components of the product. Reduction of doses of Lamivudine is recommended for patients with low body weight (less than 50 kg or 110 lb); therefore, patients with low body weight should not receive Lamivudine & Zidovudine.
","Side effects of this medicine-
+
+- More common: Chills, fever, pale skin; sore throat; unusual tiredness or weakness, headache
+- Less common: Abdominal pain, burning, tingling, numbness, or pain in the hands, arms, feet, or legs, muscle tenderness and weakness, nausea, skin rash, vomiting, yellow eyes or skin. Coughing, decreased appetite, diarrhea, dizziness and trouble in sleeping may occurs
+
","Pregnancy Category C. There arc no adequate and well controlled studies of this drug in pregnant women. This drug should be used during pregnancy only if the potential benefits outweigh the risks. The Centers for Disease Control and Prevention recommend that HIV-infected mothers should not breast-feed their infants to avoid risking postnatal transmission of HIV. Because of the potential for HIV transmission and the potential for serious adverse effects in nursing infants, mothers should be instructed not to breast feed if they are receiving efavirenz.
","Patients with HIV and Hepatitis B virus Coinfection: Safety and efficacy of Lamivudine have not been established for treatment of chronic hepatitis B in patients dually infected with HIV and HBV. Emergence of hepatitis B virus variants associated with resistance to Lamivudine has also been reported in HIV-infected patients who have received Lamivuuine-containing antiretroviral regimens in the presence of concurrent infection with Hepatitis B virus. Post-treatment exacerbations of hepatitis have also been reported.
Patients with Impaired Renal Function: Reduction of the dosages of Lamivudine and Zidovudine is recommended for patients with impaired renal function. Patients with creatinine clearance <50 ml/min should not receive this combination tablet.
Fat Redistribution: Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast
enlargement, and cushingoid appearance have been observed in patients receiving antiretroviral therapy.
",,,,,"Stored at a cool and dry place, protected from light and moisture. Keep the medicine out of the reach of children.
",10
+654,Lamivudine [For HIV Infection],lamivudine-for-hiv-infection-654,https://medex.com.bd/attachments/Bln2GZ5FsuGhBAyY71pXO8JBs11U3C/lamivudine-for-hiv-infection-prescribing-information,Drugs for HIV / Anti-retroviral drugs,HIV infection,"Lamivudine in combination with other antiretroviral agents is indicated for the treatment of HIV infection.
","Drugs for HIV / Anti-retroviral drugs
","Lamivudine is a synthetic nucleoside analogue. Lamivudine is phosphorylated intracellularly to lamivudine triphosphate. Incorporation of the monophosphate form into viral DNA occurs by hepatitis B virus (HBV) polymerase. As a result DNA chain is terminated. Lamivudine triphosphate also inhibits the RNA and DNA dependent DNA polymerase activities of HIV-1 reverse transcriptase (RT). Lamivudine triphosphate is a very weak inhibitor of mammalian alpha, beta, and gamma-DNA polymerases.
","Adults and adolescents over 12 years of age: The recommended dose for HIV infection is 300 mg daily. This is administered as 150 mg twice daily.
Children:
+
+- Three months to 12 years of age: The recommended dose for HIV infection is 4 mg/kg twice daily up to a maximum of 300 mg daily.
+- Less than three months of age: The limited data available are insufficient to propose specific dosage recommendations.
+
","Lamivudine may be administered with or without food.
","The possibility of interactions with other medicinal products administered concurrently should be considered, particularly when the main route of elimination is active renal secretion. Administration of trimethoprim/sulfamethoxazole 160 mg/800 mg results in a 40% increase in Lamivudine exposure. Lamivudine and zalcitabine may inhibit the intracellular phosphorylation of one another. Therefore, use of Lamivudine in combination with zalcitabine is not recommended.
","Hypersensitivity to Lamivudine or to any of the excipients.
","The following adverse events have been reported during therapy for HIV disease with Lamivudine.
Blood and lymphatic systems disorders-
+
+- Uncommon: Neutropenia, anaemia and thrombocytopenia
+- Very rare: Pure red cell aplasia
+
+Nervous system disorders-
+
+- Common: Headache, insomnia
+- Very rare: Cases of peripheral neuropathy (or paraesthesia).
+
+Respiratory, thoracic and mediastinal disorders
+
+- Common: Cough, nasal symptoms-
+
+Gastrointestinal disorders-
+
+- Common: Nausea, vomiting, abdominal pain or cramps, diarrhea
+- Rare: Rises in serum amylase. Cases of pancreatitis have been reported.
+
+Hepatobiliary disorders-
+
+- Uncommon: Transient rises in liver enzymes (AST, ALT).
+- Rare: Hepatitis
+
+Skin and subcutaneous tissue disorders-
+
+- Common: Rash, alopecia
+
+Musculoskeletal and connective tissue disorders-
+
+- Common: Arthralgia, muscle disorders
+- Rare: Rhabdomyolysis, Lipodystrophy
+
+General disorders and administration site conditions-
+
+- Common: Fatigue, malaise, fever.
+
+Cases of lactic acidosis, usually associated with severe hepatomegaly and hepatic steatosis, have been reported with the use of nucleoside analogues.
","Pregnancy Category C. The safety of Lamivudine in human pregnancy has not been established.
Lactation: Following oral administration Lamivudine excreted in breast milk at similar concentrations to those found in serum. That’s why it is recommended that mothers taking Lamivudine do not breast-feed their infants.
","Lamivudin is not recommended for use as monotherapy. In pediatric patients with a history of prior antiretroviral nucleoside exposure, a history of pancreatitis, or other significant risk factors for the development of pancreatitis, Lamivudine should be used with caution. Treatment with Lamivudine should be stopped immediately if clinical signs, symptoms, or laboratory abnormalities suggestive of pancreatitis occur
Lactic Acidosis/Severe Hepatomegaly with Steatosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including Lamivudine and other antiretrovirals. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Particular caution should be exercised when administering Lamivudine to any patient with known risk factors for liver disease.
In patients with moderate to severe renal impairment, the dose should be adjusted. Patients receiving Lamivudin or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with associated HIV diseases.
","Renal impairment: Lamivudine concentrations are increased in patients with moderate to severe renal impairment due to decreased clearance. The dose should therefore be adjusted.
Adults and adolescents over 12 years:
+
+- CrCl 50 ml/min: first dose 150 mg & maintenance dose 150 mg twice daily
+- CrCl 30 to <50 ml/min: first dose 150 mg & maintenance dose 150 mg once daily
+- CrCl 15 to 29 ml/min: first dose 150 mg & maintenance dose 100 mg once daily
+- CrCl 5 to 14 ml/min: first dose 150 mg & maintenance dose 50 mg once daily
+- CrCl <5 ml/min: first dose 50 mg & maintenance dose 25 mg once daily
+
+
Hepatic Impairment: Data obtained in patients with moderate to severe hepatic impairment shows that Lamivudine pharmacokinetics are not significantly affected by hepatic dysfunction. Based on these data, no dose adjustment is necessary in patients with moderate or severe hepatic impairment unless accompanied by renal impairment.
",,,,"Tablet: Store in a cool and dry place, protect from light and moisture.
Oral Solution: Store in a cool and dry place, protect from light.
",12
+1312,Lamivudine [For Chronic Hepatitis B],lamivudine-for-chronic-hepatitis-b-1312,https://medex.com.bd/attachments/8i5rbqpt4XhtA7CgmK0Rik47FlgCdW/lamivudine-for-chronic-hepatitis-b-prescribing-information,Hepatic viral infections (Hepatitis B),Hepatitis B virus,"Lamivudine is indicated for the treatment of chronic hepatitis B associated with evidence of hepatitis B viral replication and active liver inflammation.
","Hepatic viral infections (Hepatitis B)
","Lamivudine is a synthetic nucleoside analogue. Lamivudine is phosphorylated intracellularly to lamivudine triphosphate. Incorporation of the monophosphate form into viral DNA occurs by hepatitis B virus (HBV) polymerase. As a result DNA chain is terminated. Lamivudine triphosphate also inhibits the RNA and DNA-dependent DNA polymerase activities of HIV-1 reverse transcriptase (RT). Lamivudine triphosphate is a very weak inhibitor of mammalian alpha, beta, and gamma-DNA polymerases.
","The recommended oral dose of Lamivudine for the treatment of chronic hepatitis B in adults is 100 mg once daily.
",,"Trimethoprim 160 mg / Sulfamethoxazole 800 mg once daily has been shown to increase lamivudine exposure (AUC). The effect of higher doses of trimethoprim /sulfamethoxazole on lamivudine pharmacokinetics has not been investigated.
","Lamivudine is contraindicated in patients hypersensitive to any of the components of the product.
","Several serious adverse events reported with lamivudine (lactic acidosis and severe hepatomegaly with steatosis, post treatment exacerbations of hepatitis B, pancreatitis, and emergence of viral mutants associated with reduced drug susceptibility and diminished treatment response). Malaise, fatigue, fever, ENT infections, sore throat, nausea, vomiting, abdominal discomfort, pain, diarrhea, myalgia, arthralgia, headache, skin rashes may occur. Lactic acidosis and severe hepatomegaly with steatosis, have been reported.
","There is no adequate and well-controlled study in pregnant women. Lamivudine should be used during pregnancy only if the potential benefits outweigh the risks. Although it is not known if lamivudine is excreted in human milk, there is the potential for adverse effects from lamivudine in nursing infants. Mothers should be instructed not to breast feed if they are receiving lamivudine.
","Patients should be assessed before beginning treatment and during treatment with lamivudine by a physician experienced in the management of chronic hepatitis B.
","It is recommended that doses of Lamivudine should be adjusted in accordance with renal function. Dosage adjustment of Lamivudine in accordance with creatinine clearance is as follows:
+
+- CrCl 50 ml/min: 100 mg once daily
+- CrCl 30-49 ml/min: 100 mg first dose, then 50 mg once daily
+- CrCl 15-29 ml/min: 100 mg first dose, then 25 mg once daily
+- CrCl 5-14 ml/min: 35 mg first dose, then 15 mg once daily
+- CrCl <5 ml/min: 35 mg first dose, then 10 mg once daily
+
+
Use in children: Safety and efficacy of lamivudine for the treatment of chronic hepatitis B in children have not been established.
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+653,Lactulose,lactulose-653,https://medex.com.bd/attachments/uF1q5WyyVDNDYiFulZipARDNpIsttu/lactulose-prescribing-information,Osmotic purgatives,Osmotic laxative,"Constipation (Chronic Constipation): In every case of chronic constipation, initial treatment should consist of a diet rich in fiber (vegetables, salads, fruits etc.) a generous amount of liquids and much physical exercise. Lactulose is only to be taken when these measures prove insufficient.
... Read more
Constipation (Chronic Constipation): In every case of chronic constipation, initial treatment should consist of a diet rich in fiber (vegetables, salads, fruits etc.) a generous amount of liquids and much physical exercise. Lactulose is only to be taken when these measures prove insufficient.
Intestinal flora disturbances:
+
+- In damaged to intestinal flora (e.g. following long-term antibiotic treatment)
+- gall bladder diseases
+- intestinal diseases ( Colitis, Diverticulosis, Megacolon)
+
+Increased blood ammonia levels (hyper ammoniemia in hepatopathy, portal-systemic encephalopathy)
","Osmotic purgatives
","Lactulose is a synthetic disaccharide. Lactulose is metabolized in the colon by the saccharolytic bacteria, producing low molecular weight organic acids (mainly lactic acid), which lowers the pH of the colon contents, promote the retention of water by an osmotic effect; thus increasing peristaltic activity. Lactulose is minimally absorbed; therefore, the pharmacokinetics of the absorbed material are not relevant to the principal therapeutic action.
","In constipation ( chronic constipation):
+
+- Adults: Initially 3-6 tea-spoons daily, In long-term therapy 1½-6 tea-spoons daily
+- Children up to 14 years: Initially 3 tea-spoons daily, In long-term therapy 1-2 tea-spoons daily
+- Infants and toddlers: Initially 1-2 tea-spoons daily, In long-term therapy 1 tea-spoon daily
+
+In damaged intestinal flora:
+
+- Adults: 1-2 tea-spoons daily
+- Children: 1 tea-spoon daily
+
+For reduction of blood ammonia level:
+
+- Hyper-ammoniemia in hepatopathy: a maximum of 18-30 tea-spoons daily.
+- In portal systemic encephalopathy: hourly doses of 6-9 tea-spoons of Lactulose solution may be used to induce the rapid laxation. When the laxative effect has been achieved, the dose may then be reduced.
+
",,"There is no significant drug interactions with lactulose. The glycosidic effect of cardiac glycosides can be intensified by potassium deficiency in abuse.
","Hypersensitivity to either galactose and or lactose; galactose-free diet, gastro-cardial symptom complex, suspected intestinal obstruction.
","Occasionally flatulence, cramp and abdominal discomfort can occur at the beginning of treatment; this is rapidly eliminated by reducing the dose. Overdose can result in diarrhoea. In abuse, loss of electrolytes (primarily potassium).
","US FDA Pregnancy Category of Lactulose is B. Studies show that Lactulose has no adverse effects. Decisions regarding use during pregnancy and lactation must be made by registered physician.
","Lactulose should be administered with care to patients who are intolerant to lactulose. The dose used in the treatment of (pre) coma hepaticum is usually much higher and may need to be taken into consideration for diabetics.
",,"There have been no reports of accidental overdosage. In the event of acute overdosage it is expected that diarrhoea and abdominal cramps would be the major symptoms.
",,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",11
+2008,Lactobacillus Rhamnosus GG,lactobacillus-rhamnosus-gg-2008,,,,"Probiotics contain different types of micro-organisms such as yeast (saccharomyces boulardii) and bacteria (such as lactobacillus, bifidobacterium). Micro-organisms (flora) are naturally found in the stomach/intestines/vagina. Some conditions (such as antibiotic use, travel) can change the ... Read more
Probiotics contain different types of micro-organisms such as yeast (saccharomyces boulardii) and bacteria (such as lactobacillus, bifidobacterium). Micro-organisms (flora) are naturally found in the stomach/intestines/vagina. Some conditions (such as antibiotic use, travel) can change the normal balance of bacteria/yeast. Probiotics are used to improve digestion and restore normal flora.Probiotics have been used to treat bowel problems (such as diarrhea, irritable bowel), eczema, vaginal yeast infections, lactose intolerance, and urinary tract infections.Probiotics are available in foods (such as yogurt, milk, juices, soy beverages) and as dietary supplements (capsules, tablets, powders). Different products have different uses. Check the label for information on uses for your particular product.Some diet supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details regarding the particular brand you use.The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.
",,,"For general use as a dietary supplement: Dose: 1 capsule per day
Concurrently with antibiotics: Dose: 1 capsule twice a day throughout antibiotic therapy and for one week after antibiotic therapy
Traveling: Dose: 1 capsule twice daily throughout the trip. It is best to start 2 to 3 days prior to travel.
",,"Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
",,"An increase in stomach gas or bloating may occur. If this effect persists or worsens, notify your doctor or pharmacist promptly. A very serious allergic reaction to this product is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
","During pregnancy, this product should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown whether this product passes into breast milk. Consult your doctor before breastfeeding.
","Before using this product, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
If you have any of the following health problems, consult your doctor or pharmacist before using this product: diarrhea lasting more than 2 days (especially if you also have a high fever), weakened immune system (such as due to chemotherapy, HIV infection), recurring vaginal infections, recurring urinary tract infections.
Liquid products, foods, powders, or chewable tablets may contain sugar and/or aspartame. Caution is advised if you have diabetes, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
",,,,,"Different types of probiotics may have different storage needs. Some may require refrigeration while others should not be refrigerated. Check the product package for instructions on how to store your product.
",7
+661,Lactitol Monohydrate,lactitol-monohydrate-661,https://medex.com.bd/attachments/SpSAEQR65wQvug8caTN3ovd5hufZ1A/lactitol-monohydrate-prescribing-information,Osmotic purgatives,Hepatic encephalopathy,"Lactitol Monohydrate is indicated in chronic idiopathic constipation (CIC), acute and chronic portal systemic encephalopathy.
","Osmotic purgatives
","Lactitol Monohydrate is a disaccharide derivatives consisting of galactose and sorbitol, which is only minimally absorbed and is not hydrolysed by the disaccharidases of the GIT and thus reaches the colon unchanged. In the colon it is broken down to short chain low molecular weight organic acids by the intestinal flora, resulting in an increase in osmotic pressure in the colon, thereby causing an increase in the stool water content and stool volume, which explains the laxative effect. Lactitol Monohydrate produces its effect in the lumen of the colon, where it is virtually 100% bioavailable. It is absorbed only in minimal amounts. Up to 2% can be found unchanged in the urine.
","Lactitol can be mixed with hot or cold beverages, puddings etc. Dosage will require adjustment to obtaine one daily bowel movement in constipated patients and two daily bowel movements in patients with portal systemic encephalopathy.
In constipation: In adult: The initial daily dosage should be 20 g taken in a single dose with the morning or evening meal. After a few days, a daily dose of 10 g may be sufficient.
Children: The mean dosage is 0.25 g/kg body weight daily.
+
+- 1 to 6 years: 2.5 to 5 gm
+- 6 to 12 years: 5 to 10 gm
+- 12 to 16 years: 10 to 20 gm
+
+The effect of lactitol has been found mostly to occur within a few hours after intake. But in some cases the first laxative response may be delayed until the second or third day of administration. Therefore patients should be advised to maintain an adequate daily fluid intake.
In portal systemic encephalopathy: The dose should be adjusted according to the severity of the patient’s disease and their individual response. The initial recommended dose is 0.5 to 0.7 gm/kg body weight daily, divided into three daily doses with meals.
",,"Antacids and neomycin should not be given simultaneously with Lactitol to cirrhotic patients with portal systemic encephalopathy. Lactitol may increase potassium loss caused by other drugs e.g. thiazide diuretics, corticosteroids, carbenoxolone, amphotericin B and it may enhance the risk of toxic effects of glycosides in patients receiving concomitant therapy.
","Patients with known hypersensitivity to any of the ingredients of this preparation.
","At the start of the treatment with lactitol may produce abdominal discomforts such as flatulence, pain, cramps or sensation of fullness. Such effects tend to diminish or disappear after a few days of regular intake of Lactitol. Occasionally, nausea or anal pruritus has been reported in some cases.
","Lactitol is minimally absorbed systemically following oral administration, and it is unknown whether maternal use will result in fetal exposure to the drug. There are no data on the presence of lactitol in human or animal milk, the effects on the breastfed infant, or the effects on milk production.
","
+- Elderly or debilitated patients receiving long-term treatment with lactitol should have their serum electrolytes monitored regularly.
+- As for all laxatives, pre-existing fluid or electrolyte imbalance should be corrected before starting treatment with lactitol.
+- Following treatment of Lactitol, hydrogen may accumulate in the bowel. Patients who need to undergo electrocauterisation procedure should therefore have a thorough bowel cleansing with a non-fermentable solution.
+- Lactitol is not recommended in case s of ileostomy or colostomy.
+- Prolonged use of laxatives without interruption should be avoided.
+
",,,,,"Store in a cool, dry place and away from light. Keep out of reach of children.
",10
+660,Lactic acid + Sodium PCA,lactic-acid-sodium-pca-660,,Emollients & combined preparations,Skin care,"This medication is used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations (e.g., diaper rash, skin burns from radiation therapy). Emollients are substances that soften and moisturize the skin and ... Read more
This medication is used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations (e.g., diaper rash, skin burns from radiation therapy). Emollients are substances that soften and moisturize the skin and decrease itching and flaking. Some products (e.g., zinc oxide, white petrolatum) are used mostly to protect the skin against irritation (e.g., from wetness).
","Emollients & combined preparations
","Lactic acid: It is commonly used for lubricating and moisturising skin, thus relieving dryness and itch.
Sodium PCA: It is a keratolytic agent. It encourages exfoliation of the skin and opening up of the plugged follicles, which helps re-establish the normal skin- cell replacement cycle. For milder acne, salicylic acid helps unclog pores to resolve and prevent lesions.
","Use as required on affected areas.
",,,"Hypersensitivity
","Most emollients can be used safely and effectively with no side effects. However, burning, stinging, redness, or irritation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
","Pregnancy category is not classified. FDA has not yet classified the drug into a specified pregnancy category.
","Before using this product, tell your doctor or pharmacist if you are allergic to any of the ingredients in the product; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
",,,,,,8
+1837,Lactic acid + Citric acid + Potassium bitartrate,lactic-acid-citric-acid-potassium-bitartrate-1837,https://medex.com.bd/attachments/x28eNCxnQra2ULYKTlrYFqn5XLTgLg/lactic-acid-citric-acid-potassium-bitartrate-prescribing-information,Miscellaneous topical agents,Contraception,"This is a combination of lactic acid, citric acid, and potassium bitartrate indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.
","Miscellaneous topical agents
",,"The combination of lactic acid, citric acid, and potassium bitartrate comes as a gel in a pre-filled applicator to be applied into the vagina. It is usually applied into the vagina immediately before (up to one hour) before each act of vaginal intercourse. If more than one act of vaginal intercourse occurs within one hour, apply another dose into the vagina. Do not apply more or less of it or apply it more often than prescribed by your doctor.
Lactic acid, citric acid, and potassium bitartrate vaginal gel may be used at any time during the menstrual cycle. It may be used with hormonal contraceptives (birth control pills, patches, or implants); latex, polyurethane and polyisoprene condoms; or a vaginal diaphragm. Do not use this medication along with a contraceptive vaginal ring. Lactic acid, citric acid, and potassium bitartrate vaginal gel may be applied after your doctor has told you that it is safe to resume vaginal intercourse after childbirth, abortion, or miscarriage.
","To use the lactic acid, citric acid, and potassium bitartrate vaginal gel, follow these steps:
+
+- Wash your hands with soap and water before opening the foil pouch.
+- Remove the pre-filled applicator and plunger rod from the foil pouch.
+- Slowly insert the plunger rod into the pre-filled applicator. Push until you feel the tip of the plunger rod connect to the inside of the pre-filled applicator.
+- Do not push hard or continue to push after the tip of the plunger rod connects to the inside of the pre-filled applicator as it could cause the gel to go into the pink cap. Use a new pre-filled applicator if the gel enters the pink cap.
+- After the plunger rod is connected to the pre-filled applicator, remove the pink cap from the pre-filled applicator. The extra space between the gel and the end of the pre-filled applicator is normal.
+- Hold the pre-filled applicator at the grooved area closest to the plunger rod. Gently insert the pre-filled applicator into the vagina as far as it will comfortably go while you continue to hold the plunger rod. You can do this while sitting with your knees apart, lying on your back with your knees bent, or while standing with your feet apart or knees bent.
+- While the pre-filled applicator is inserted in your vagina, use your index finger to push the plunger rod down until it stops to ensure that you receive the entire dose. It is normal for a small amount of gel to be left in the applicator.
+- Gently remove the plunger rod and pre-filled applicator from the vagina. Discard the used pre-filled applicator and cap in the trash.
+
",,,"Most common adverse reactions (≥2%) were vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal mycotic infection, urinary tract infection, vulvovaginal discomfort, bacterial vaginosis, vaginal discharge, genital discomfort, dysuria, and vulvovaginal pain.
","There is no use in pregnancy; therefore, discontinue this during pregnancy. There are no data on the presence of lactic acid, citric acid, and potassium bitartrate or their metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.
","Before using lactic acid, citric acid, and potassium bitartrate vaginal,
+
+- tell your doctor and pharmacist if you or your sexual partner are allergic to lactic acid, citric acid, and potassium bitartrate, any other medications, or any of the ingredients in lactic acid, citric acid, and potassium bitartrate vaginal gel. Ask your pharmacist for a list of the ingredients.
+- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take or use. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
+- tell your doctor if you have or had urinary tract infections or problems with urination.
+- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using lactic acid, citric acid, and potassium bitartrate vaginal, call your doctor.
+
","Pediatric Use: The safety and effectiveness of this gel have been established in females of reproductive potential. Efficacy is expected to be the same for post-menarchal females under the age of 17 as for users 17 years and older. The use of this gel before menarche is not indicated.
",,,,"Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture
",9
+1151,Lactase,lactase-1151,,,,"Prevention of symptoms of lactose intolerance-
+
+- Infantile colic
+- Abdominal pain
+- Bloating
+- Flatulence
+- Diarrhea
+- Borborygmi
+
",,"Lactase is an enzyme that helps to prevent symptoms of lactose intolerance by breaking down milk sugar (lactose) to produce glucose and galactose via hydrolysis and making dairy foods easier to digest.
","Adult: 1 tablet (300 mg) with dairy food. If needed dose can be adjusted up to 2 tablets (600 mg) at a time.
Infants: Add lactase enzyme to breast milk or formula in the following directions-
Breast Milk:
+
+- Express a few tablespoons (2-3 tablespoons) of breast milk into sterilized container
+- Add 4 drops of lactase paediatric drops
+- Give mixture to infant on a spoon or oral syringe before initiating breastfeeding
+- Breast feed as normal
+
+Formula:
+
+- Add 4 drops of lactase paediatric drops to warm (not hot) formula
+- Wait 30 minutes, shaking formula occasionally
+
+Making formula in advance:
+
+- Add 2 drops of lactase paediatric drops to warm formula
+- Store in refrigerator for minimum 4 hours
+- Feed Infant as normal
+- Use within 12 hour
+- Discard any unused formula
+
+
Children: Effective & safe in children above 4 years of age.
",,"No information for lactase interactions has been found yet.
","This drug is contraindicated in patients with known hypersensitivity to lactase or any other components of the product.
","There are no major side effects reported. The very few side effects may include rash, difficulty in breathing, tightness in chest etc.
","It is unknown if lactase may cause harm to the fetus. Therefore, lactase should be given during pregnancy only when clearly needed. It is unknown if lactase is excreted in breast milk. Thus, lactase should be given during lactation only when clearly needed.
",,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",8
+1418,Lacosamide,lacosamide-1418,https://medex.com.bd/attachments/KFP43lQdOVLhXzXhL3GvDzIjrhaK2N/lacosamide-prescribing-information,Atypical anti-depressant drugs,Seizures,"Lacosamide is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
As the safety of Lacosamide injection has not been established in pediatric patients, Lacosamide injection is indicated for the treatment of partial-onset seizures only in adult patients (17 years of age and older)
","Atypical anti-depressant drugs
","It is proposed that lacosamide's inhibition of sodium channels is responsible for analgesia. Lacosamide may be selective for inhibiting depolarized neurons rather than neurons with normal resting potentials. Pain and nociceptor hyperexcitability are associated with neural membrane depolarization. Lacosamide binds to collapsin response mediator protein-2 (CRMP-2), a phosphoprotein which is expressed primarily in the nervous system and is involved in neuronal differentiation and control of axonal outgrowth. The role CRMP-2 of binding in seizure control is hasn't been elucidated.
","Adults (17 years and older): Initial dosage for monotherapy is 100 mg twice daily; initial dosage for adjunctive therapy is 50 mg twice daily; maximum recommended dosage for monotherapy and adjunctive therapy is 200 mg twice daily
Pediatric Patients 4 Years to less than 17 years: The recommended dosage is based on body weight and is administered orally twice daily. Increase dosage based on clinical response and tolerability, no more frequently than once per week
Injection: for intravenous and adult use only when oral administration is temporarily not feasible; dosing regimen is the same as oral regimen; administer over 15 to 60 minutes; obtaining ECG before initiation is recommended in certain patients
",,"Strong CYP3A4 or CYP2C9 Inhibitors: Patients with renal or hepatic impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 may have a significant increase in exposure to Lacosamide. Dose reduction may be necessary in these patients.
Concomitant Medications that Prolong PR Interval: Lacosamide should be used with caution in patients on concomitant medications that prolong PR interval, because of a risk of AV block or bradycardia, e.g., beta-blockers and calcium channel blockers. In such patients, obtaining an ECG before beginning Lacosamide, and after Lacosamide is titrated to steady-state, is recommended. In addition, these patients should be closely monitored if they are administered Lacosamide through the intravenous route
","None
","Adjunctive therapy: Most common adverse reactions in adults (≥10% and greater than placebo) are diplopia, headache, dizziness, nausea
Monotherapy: Most common adverse reactions are similar to those seen in adjunctive therapy studies
Pediatric patients: Adverse reactions are similar to those seen in adult patients
","Pregnancy: Based on animal data, may cause fetal harm
","Monitor patients for suicidal behavior and ideation
Lacosamide may cause dizziness and ataxia
Cardiac Rhythm and Conduction Abnormalities: Obtaining ECG before beginning and after titration to steady-state maintenance is recommended in patients with known cardiac conduction problems, taking drugs known to induce PR interval prolongation, or with severe cardiac disease; closely monitor these patients
Lacosamide may cause syncope
Lacosamide should be gradually withdrawn to minimize the potential of increased seizure frequency
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity: Discontinue if no alternate etiology
","Dose adjustment is recommended for severe renal impairment. Dose adjustment is recommended for mild or moderate hepatic impairment; use in patients with severe hepatic impairment is not recommended
",,,,"Store at 20°C to 25°C
",11
+652,Lacidipine,lacidipine-652,https://medex.com.bd/attachments/U1hsi1xlwDz4islkdm9YiotmuMPQIL/lacidipine-prescribing-information,Calcium-channel blockers,Stroke,"Lacidipine is indicated for the treatment of hypertension either alone or in combination with other antihypertensive agents, including ß-blockers, diuretics, ACE-inhibitors etc.
","Calcium-channel blockers
","Lacidipine inhibits the influx of calcium into smooth muscle cells by the competitive inhibition of voltage-dependent calcium 'L' channels. This action results in the inhibition of the effects triggered by the influx of calcium into the cells, such as the activation of the contractile proteins in smooth muscle.
","The recommended initial dose of Lacidipine is 2 mg once daily. The dose may be increased to 4 mg and then, if necessary, to 6 mg after 3 to 4 weeks. Lacidipine should be taken preferably in the morning.
",,"The plasma concentration of Lacidipine may be increased by simultaneous administration of cimetidine. No specific pharmacodynamic interaction problems have been identified in studies with common antihypertensive agents or with digoxin, tolbutamide or warfarin.
","Hypersensitivity to any ingredient of this product, cardiogenic shock, unstable angina, aortic stenosis, avoid within 1 month of myocardial infarction, impaired left ventricular function.
","Lacidipine is generally well tolerated. Some individuals may experience minor side effects like flushing, palpitation, edema, headache, dizziness, rarely gastro-intestinal disturbances, gum hyperplasia, mood disturbances, asthenia, polyuria, muscle cramps, skin rash etc.
","Pregnancy: There are no data on the safety of Lacidipine in human pregnancy. Lacidipine provides no evidence of a teratogenic effect in animal study.
Lactation: Milk transfer studies in animals have shown that Lacidipine (or its metabolites) are likely to be excreted into breast milk. There is, however, no clinical experience of Lacidipine in pregnancy and lactation. Accordingly, Lacidipine should not be used during pregnancy or lactation.
","Cardiac conduction abnormalities, poor cardiac reserves, hepatic impairment, withdraw if ischemic pain occurs shortly after initiating treatment or if cardiogenic shock develops, avoid grape fruit juice.
","Use in Neonates: There are no data on safety or efficacy of Lacidipine in neonates.
Use in children: Treatment with Lacidipine have not been evaluated in Children.
Hepatic Impairment: Severe: Reduce dose.
","Symptoms: Prolonged peripheral vasodilation associated with hypotension and tachycardia, bradycardia or prolonged AV conduction.
Management: Symptomatic and supportive treatment.
",,,"Store in a cool and dry place, protect from light and moisture. Keep out of the reach of children.
",12
+651,Labetalol Hydrochloride (Tablet),labetalol-hydrochloride-tablet-651,https://medex.com.bd/attachments/s2wgeHWW2IiewQUqdsuRmWDYPilQOr/labetalol-hydrochloride-tablet-tablets-prescribing-information,Alpha adrenoceptor blocking drugs,Hypotensive anaesthesia,"Labetalol Hydrochloride indicated in the management of hypertension. Labetalol tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.
","Alpha adrenoceptor blocking drugs, Beta-adrenoceptor blocking drugs
","Labetalol non-selectively antagonizes beta-adrenergic receptors, and selectively antagonizes alpha-1-adrenergic receptors. Following oral administration, labetalol has 3 times the beta-blocking ability than alpha-blocking ability. This increases to 6.9 times following intravenous administration. Antagonism of alpha-1-adrenergic receptors leads to vasodilation and decreased vascular resistance. This leads to a decrease in blood pressure that is most pronounced while standing. Antagonism of beta-1-adrenergic receptors leads to a slight decrease in heart rate. Antagonism of beta-2-adrenergic receptors leads to some of the side effects of labetalol such as bronchospasms, however this may be slightly attenuated by alpha-1-adrenergic antagonism. Labetalol leads to sustained vasodilation over the long term without a significant decrease in cardiac output or stroke volume, and a minimal decrease in heart rate.
","Adult: The recommended initial dosage is 100 mg twice daily whether used alone or added to a diuretic regimen. The usual maintenance dosage of Labetalol Hydrochloride is between 200 and 400 mg twice daily.
Patients with severe hypertension: May require from 1,200 to 2,400 mg per day, with or without thiazide diuretics. Titration increments should not exceed 200 mg twice daily.
Elderly Patients: The majority of elderly patients will require between 100 and 200 mg twice daily.
",,"Labetalol in combination with tricyclic antidepressants may cause tremor; Cimetidine has been shown to increase the bioavailability of Labetalol. If Labetalol is used with nitroglycerin in patients with angina pectoris, additional antihypertensive effects may occur; Care should be taken if Labetalol is used concomitantly with calcium antagonists of the verapamil type; Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
",,"Most side effects are mild and transient and occur early in the course of treatment. The incidences of adverse reactions include Fatigue, Asthenia, Headache, Nausea, Vomiting, Dyspepsia, Abdominal pain, Diarrhea, Taste distortion, Dizziness, Paresthesia, Nasal stuffiness, Increased sweating, Edema, Postural hypotension, Bradycardia, Dyspnea, Rash, Vision abnormality and Vertigo.
","Pregnancy Category C. Teratogenic studies were performed with Labetalol in rats and rabbits at oral doses up to approximately six and four times the maximum recommended human dose (MRHD), respectively. No reproducible evidence of fetal malformations was observed. Labetalol Hydrochloride given to pregnant women with hypertension did not appear to affect the usual course of labor and delivery. Small amounts of Labetalol (approximately 0.004% of the maternal dose) are excreted in human milk. Caution should be exercised when Labetalol tablets are administered to a nursing woman.
","Labetalol Hydrochloride should be used with caution in patients with Impaired Hepatic Function, Congestive Heart Failure, Exacerbation of Ischemic Heart Disease, Nonallergic Bronchospasm, Pheochromocytoma, Diabetes Mellitus and Hypoglycemia.
",,"Overdosage with Labetalol causes excessive hypotension and sometimes, excessive bradycardia. If overdosage with Labetalol follows oral ingestion, gastric lavage or pharmacologically induced emesis (using syrup) may be useful for removal of the drug shortly after ingestion. The following additional measures should be employed if necessary: Excessive bradycardia-administer atropine or epinephrine; Cardiac failure-administer a digitalis glycoside and a diuretic; Hypotension-administer vasopressors, e.g., norepinephrine; Bronchospasm administer epinephrine and/or an aerosolized beta2-agonist; Seizures-administer diazepam. In severe beta blocker overdose resulting in hypotension and/or bradycardia, glucagon has been shown to be effective when administered in large doses (5 to 10 mg rapidly over 30 seconds, followed by continuous infusion of 5 mg per hour that can be reduced as the patient improves).
",,,"Labetalol tablets should be stored below 30°C. Keep out of the reach of children. Store in a cool and dry place protected from light.
",10
+1821,Labetalol Hydrochloride (Injection),labetalol-hydrochloride-injection-1821,,Alpha adrenoceptor blocking drugs,Severe hypertension,"Labetalol Injection is indicated in Hypertension (including hypertension in pregnancy, hypertension after stroke, hypertension with angina, and hypertension following acute myocardial infarction); hypertensive crisis; Anaesthesia when a hypotensive technique is indicated.
","Alpha adrenoceptor blocking drugs, Beta-adrenoceptor blocking drugs
","Labetalol is a competitive antagonist at b1 and b2 adrenoreceptors and has some intrinsic activity at b2 adrenoreceptors. Labetalol has, in addition to its b-blocking action, a competitive antagonist action at postsynaptic a-adrenoreceptors. In isolated tissues Labetalol is four to eight times more potent at b than a-adrenoreceptors.
","Bolus Injection: If it is essential to reduce the blood pressure quickly a dose of 50 mg should be given by intravenous injection (over a period of at least one minute) and, if necessary, repeated at five minute intervals until a satisfactory response occurs. The total dose should not exceed 200 mg.
Intravenous Infusion: For intravenous infusion the injcetion should be diluted with a suitable intravenous infusion fluid to a concentation of 1 mg/1 ml. Compatible fluids include solution of 5% Dextrose, 0.9% Sodium Chloride and mixture of Sodium Chloride and Dextrose Injection.
Hypertension in pregnancy: Initially 20 mg/hour, then doubled every 30 minutes until a satisfactory response is obtained or a dosage of 160 mg/hour is reached.
Hypertension following acute myocardial infarction: Initially 15 mg/hour and gradually increased to a maximum of 120 mg/hour depending on the control of blood pressure.
Hypertension after stroke: 10-20 mg by intravenous injection over 1 to 2 minutes may repeat or doubled every 10 minutes. (max. dose 300 mg).
Hypertension due to other causes: Infuse at a rate of about 2 mg/min until a satisfactory response is obtained, then stop infusion. The effective dose is usually 50-200 mg but larger doses may be needed, especially in patients with phaeochromocytoma.
Hypotensive anaesthesia: The recommended starting dose of Labetalol Injection is 10-20 mg intravenously depending on the age and condition of the patient. Patients for whom halothane is contraindicated usually require a higher initial dose of 25-30 mg. If satisfactory hypotension is not achieved after 5 minutes, increments of 5-10 mg should be given until the desired level of blood pressure is attained.
",,"Labetalol may enhance the hypotensive effects of halothane. Care should be taken if labetalol is used concomitantly with either Class I antiarrhythmic agents or calcium antagonists of the verapamil type. The hypotensive effect of Labetalol may be reduced when used in combination with prostaglandin synthetase inhibitors (NSAIDs). Dosage adjustments may therefore be necessary. Concomitant use of tricyclic antidepressants may increase the incidence of tremor. Cimetidine may increase the bioavailability of Labetalol and care is required in oral dosing of the latter.
","Labetalol is contraindicated for patients known to have hypersensitivity to the medicine. Labetalol is contraindicated in second or third degree heart block, infranodal A-V block, uncontrolled heart failure, sick-sinus syndrome, cardiogenic shock and other conditions associated with severe and prolonged hypotension or severe bradycardia, and bronchial asthma or other obstructive lung disorders.
","Adverse effects reported are postural hypotension (avoid upright position during and for 3 hours after intravenous administration), tiredness, weakness, headache, rashes, scalp tingling, difficulty in micturition, epigastric pain, nausea, vomiting; liver damage.
","Labetalol should only be used during the first trimester of pregnancy if the potential benefit outweighs the potential risk. Labetalol is excreted in breast milk in small amounts. Caution should be exercised when labetalol is administered to breast feeding women.
","There have been rare reports of severe hepatocellular injury with Labetalol therapy. The hepatic injury is usually reversible and has occurred after both short and long term treatment. If there is laboratory evidence of liver injury or the patient is jaundiced, Labetalol therapy should be stopped and not re-started. Particular care should be taken when Labetalol is to be used in patients with hepatic impairment. Labetalol should be used with caution in patients with peripheral vascular disease as their symptoms may be exacerbated.
",,"Profound cardiovascular effects are to be expected, e.g. excessive, posture-sensitive hypotension and sometimes bradycardia. Patients should be laid supine with the legs raised. Use a cardiac glycoside and a diuretic in cardiac failure; for bronchospasm, administer a b 2 -agonist per aerosol. Intravenous atropine 0.25 to 3 mg should be given to relieve bradycardia. Intravenous noradrenaline 5 to 10 mg initially, repeated according to response may be preferable to isoprenaline to improve circulation. Alternatively, noradrenaline may be infused at a rate of 5 mg per minute until the response is satisfactory. In severe overdose, intravenous glucagon may be preferred: an initial bolus dose of 5 to 10 mg in dextrose or saline should be followed by an intravenous infusion of 5 mg/hour or as sufficient to maintain cardiac output.
",,,"Store in a cool & dry place protected from light. Keep out of reach of children.
",11
+1339,L-Ornithine L-Aspartate + Pancreatin,l-ornithine-l-aspartate-pancreatin-1339,,Digestive Enzyme,Pancreatitis,"L-Ornithine-L-Aspartate / Pancreatin is used for the treatment, control, prevention, & improvement of the following diseases, conditions and symptoms:
+
+- Hepatic encephalopathy
+- Digestion of food
+- Inflammatory disease of the pancreas
+
","Digestive Enzyme
","Pancreatin is a preparation of Pancreatin having protease, lipase and amylase enzyme activity. Pancreatin hydrolyses fats to glycerol and fatty acids, changes protein into proteoses and derived substances and converts starch into dextrins and sugars. Pancreatin is employed in the conditions where the secretion of pancreatic juice is defcient.
Hepatic encephalopathy continues to be a major clinical problem and the current decade has not witnessed major therapeutic breakthroughs in this area. L-ornithine-L-aspartate (LOLA) is not frequently used as there are still some reservations about its benefits. The present study aimed to assess the effectiveness and safety of LOLA in the management of hepatic encephalopathy.
","1-2 tablets daily
",,"If you use other drugs or over the counter products at the same time, the effects of L-Ornithine-L-Aspartate / Pancreatin may change. This may increase your risk for side-effects or cause your drug not to work properly. Tell your doctor about all the drugs, vitamins, and herbal supplements you are using, so that you doctor can help you prevent or manage drug interactions. L-Ornithine-L-Aspartate / Pancreatin may interact with the following drugs and products:
+
+- Herbal products
+- Over-the-counter medicines
+- Prandase
+- Precose
+- Vitamins
+
","Hypersensitivity to L-Ornithine-L-Aspartate / Pancreatin is a contraindication. In addition, L-Ornithine-L-Aspartate / Pancreatin should not be used if you have the following conditions:
+
+- Gastrectomy
+- Hypersensitivity
+- Pancreatectomy
+- Pregnant
+
","The following is a list of possible side-effects that may occur in medicines that contain L-Ornithine-L-Aspartate / Pancreatin. This is not a comprehensive list. These side-effects are possible, but do not always occur. Some of the side-effects may be rare but serious. Consult your doctor if you observe any of the following side-effects, especially if they do not go away.
+
+- Nausea
+- Vomiting
+- Abdominal
+- Stomach pain
+- Bloating
+- Diarrhea
+
","No data had found
","Before using L-Ornithine-L-Aspartate / Pancreatin, inform your doctor about your current list of medications, over the counter products (e.g. vitamins, herbal supplements, etc.), allergies, pre-existing diseases, and current health conditions (e.g. pregnancy, upcoming surgery, etc.). Some health conditions may make you more susceptible to the side-effects of the drug. Take as directed by your doctor or follow the direction printed on the product insert. Dosage is based on your condition. Tell your doctor if your condition persists or worsens. Important counseling points are listed below.
+
+- Avoid taking higher quantity than recommended dose
+- Avoid use of this drug if allergic to it
+- Consult your doctor before taking the drug in case of pregnancy or lactation
+- Drink plenty of water when taking pancreatin
+- Need doctor's consultation in abdominal cramps, blood in stools and loose motions
+- Planning to get pregnant or breastfeeding
+
",,,,,,9
+1440,L-Ornithine L-Aspartate,l-ornithine-l-aspartate-1440,,Digestive Enzyme,Liver disease,"This is indicated for the treatment of Hepatic Encephalopathy, Acute Liver Failure, Hyperammonemia due to Acute and Chronic Hepatitis, Fatty Liver, Alcoholic Liver damage, Adjunct to hepatotoxic drugs, Liver Cirrhosis, Post hepatitis convalescence etc.
","Digestive Enzyme
","L-Ornithine L-Aspartate is a stable combination of two important endogenous Amino Acids, L-Ornithine and L-Aspartate. After administration, it quickly breaks down into L-Ornithine and L-Aspartate. L-Ornithine being a substrate of urea cycle, converts toxic ammonia into non-toxic urea which is eliminated via kidneys, helping the diseased liver to carry out its normal function smoothly (detoxification). The process lowers the elevated level of ammonia in blood (hyperammonemia) which is a common problem in most of the liver diseases. L-Aspartate is an essential component of citric acid cycle which liberates energy (ATP), and thus helps in regeneration of damaged liver cells.
","Sachet: 1-2 sachets granules is dissolved in a large amount of fluid (e.g. in a glass of water or juice) and is taken orally 3 times a day during or after meals.
Injection (Infusion Concentrate): The recommended dose is up to 20 gm (4 ampoules daily). In case of loss of consciousness (pre-coma) and clouding of consciousness (coma) up to 8 ampoules within 24 hours, depending on the severity of the condition.
","
+- L-Ornithine L-Aspartate infusion concentrate can be added to any of the conventional intravenous fluids (0.9% Sodium Chloride, 5% Dextrose and Ringer's lactate etc.)
+- The normal dilution rate is 1 ampoule per 100 ml of I.V. fluid. However, the dose should not exceed 6 ampoules per 500 ml infusion. The solution mixtures were stable up to 24 hours.
+- Infusion Rate: 5 gm/h at maximum.
+
","No data regarding the interactions of L-Ornithine L-Aspartate was found.
",,"Very rarely side effects like nausea and vomiting occur. These side effects are usually transient and do not necessitate the withdrawal of the drug.
","The administration in pregnancy and lactation should be avoided.
","Monitoring of serum and urinary urea levels at regular intervals should be done.
",,,,,"Store in a cool and dry place, keep away from light.
",10
+1657,Levodopa + Benserazide,levodopa-benserazide-1657,https://medex.com.bd/attachments/qPpr58O8K6BbxFAqDien1B2k3yTIqo/levodopa-benserazide-prescribing-information,Antiparkinson drugs,Protects from Parkinson's disease,"Levodopa & benserazide is indicated for the treatment of all forms of Parkinson's syndrome with the exception of medicine-induced parkinsonism. Levodopa & benserazide dispersible is a formulation which is suitable for patients with dysphagia (difficulties in swallowing) or who require a formulation ... Read more
Levodopa & benserazide is indicated for the treatment of all forms of Parkinson's syndrome with the exception of medicine-induced parkinsonism. Levodopa & benserazide dispersible is a formulation which is suitable for patients with dysphagia (difficulties in swallowing) or who require a formulation with a more rapid onset of action, e.g. patients suffering from early morning and afternoon akinesia, or who exhibit ""delayed on"" or ""wearing off"" phenomena. Levodopa & benserazide HBS is indicated for patients presenting with all types of fluctuations in response, especially those related to fluctuations in plasma levels (i.e. ""peak dose dyskinesia"" and ""end of dose deterioration"") and for better control of nocturnal symptoms. Further experience is required to determine whether it is also advantageous to use Levodopa & benserazide HBS in new Parkinson patients.
","Antiparkinson drugs
","Dopamine, which acts as a neurotransmitter in the brain, is not present in sufficient quantities in the basal ganglia of parkinsonian patients. Levodopa or L-DOPA (3,4-dihydroxy phenylalanine) is an intermediate in dopamine biosynthesis. Levodopa (dopamine precursor) is used as a prodrug to increase dopamine levels since it is able to cross the blood-brain barrier whereas dopamine itself cannot. Once levodopa has entered the central nervous system, it is metabolised to dopamine by aromatic L-amino acid decarboxylase After administration, levodopa is rapidly decarboxylated to dopamine in extracerebral as well as cerebral tissues. As a result, most of the levodopa administered is not available to the basal ganglia, and the dopamine produced peripherally frequently causes unwanted effects. It is therefore particularly desirable to inhibit extracerebral decarboxylation of levodopa. This can be achieved by simultaneous administration of levodopa and benserazide, a peripheral decarboxylase inhibitor. This preparation is a combination of these two substances in a ratio of 4:1- this ratio having proved optimal in clinical trials and therapeutic use- and is just as effective as large doses of levodopa given alone.
","Standard dosage: Treatment with this combination should be introduced gradually; dosage should be assessed individually and titrated for optimal effect. The following dosage instructions should therefore be regarded as guidelines.
Initial therapy: In the early stages of Parkinson’s disease, it is advisable to start treatment with one capsule of this combination 62.5 three to four times daily. As soon as tolerability of the initial dosing schedule is confirmed, the dosage should be increased slowly in accordance with the patient’s response. An optimal effect is generally achieved with a daily dosage of this combination corresponding to 300-800 mg of levodopa 75-200 mg benserazide, to be divided into 3 or more doses. Between 4 and 6 weeks may be needed to achieve the optimal effect. If it proves necessary to further, increase the daily dosage, this should be done on a monthly basis.
Maintenance therapy: The average maintenance dosage is 1 capsule of this combination 125 three to six times daily. The number of individual doses (not less than 3) and their distribution throughout the day must be titrated for optimal effect. this combination HBS and this combination dispersible may substitute standard this combination to achieve an optimal effect.
","When taking standard this combination capsules or this combination HBS, patients must always ensure that they swallow the whole capsule without chewing it. this combination dispersible tablets are to be dispersed in a quarter of a glass of water (approx. 25-50 ml). The tablets disintegrate completely, producing a milky-white dispersion within a few minutes. Because of rapid sedimentation, it is advisable to stir the dispersion before drinking. this combination dispersible tablets should be taken within half an hour of preparing the dispersion.
Where possible, this combination should be taken at least 30 minutes before or 1 hour after meals, so that the competitive effect of dietary protein on levodopa uptake can be avoided and to facilitate a more rapid onset of action. Undesirable gastrointestinal effects, which may occur mainly in the early stages of the treatment, can largely be controlled by taking this combination with a low protein snack (e.g. biscuits) or liquid or by increasing the dose slowly.
",,"This combination is contraindicated in:
+
+- Patients with known hypersensitivity to levodopa or benserazide or any of the excipients.
+- Patients receiving non-selective monoamine oxidase (MAO) inhibitors due to the risk of hypertensive crisis. However, selective MAO-B inhibitors, such as selegiline and rasagiline, or selective MAO-A inhibitors, such as moclobemide, are not contraindicated. Combination of MAO-A and MAO-B inhibitors is equivalent to non-selective MAO inhibition, and hence this combination should not be given concomitantly with this combination.
+- Patients with decompensated endocrine, renal or hepatic function, cardiac disorders, psychiatric diseases with a psychotic component or closed angle glaucoma. Because levodopa may activate a malignant melanoma, this combination should not be used in patients with suspicious, undiagnosed lesions or a history of melanoma.
+- The management of patients with intention tremor and Huntington’s chorea.
+- Patients less than 30 years old (skeletal development must be complete).
+
",,"Pregnancy Category B3. This combination is contraindicated during pregnancy and in women of childbearing potential in the absence of adequate contraception. If pregnancy occurs in a woman taking this combination, the medicine must be discontinued (as advised by the prescribing physician). The safe use of this combination during lactation has not been established. Since it is not known whether benserazide passes into breast milk, mothers requiring this combination treatment should not nurse their infants, since the occurrence of skeletal malformations in the infants cannot be excluded.
",,"Renal impairment: Levodopa and benserazide are both extensively metabolised and less than 10% of levodopa is excreted unchanged through the kidneys. No dose reduction is therefore necessary in case of mild or moderate renal insufficiency. Pharmacokinetic data with levodopa in renal impaired patients are not available. This combination is well tolerated by uraemic patients undergoing haemodialysis.
Hepatic impairment: Levodopa is mainly metabolised by the aromatic amino acid decarboxylase that is abundantly present in the intestinal tract, in the kidney and heart in addition to the liver. Pharmacokinetic data with levodopa in hepatic impaired patients are not available.
Paediatric use: This combination is contraindicated in patients less than 30 years old
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+678,Levocetirizine Dihydrochloride,levocetirizine-dihydrochloride-678,https://medex.com.bd/attachments/X6nD3znoTgB9YgIDTgAMyzFwxUzwSU/levocetirizine-dihydrochloride-prescribing-information,Non-sedating antihistamines,Urticaria,"Levocetirizine is indicated in the treatment of symptoms associated with allergic conditions such as perennial allergic rhinitis, seasonal allergic rhinitis and chronic idiopathic urticaria.
","Non-sedating antihistamines
","This preparation contains Levocetirizine Dihydrochloride. Levocetirizine is the active (Levo) isomer of cetirizine. It is a new highly effective and well-tolerated nonsedating antihistamine with potent antiallergic properties. It has a two-fold higher affinity for H1 receptors than cetirizine. Levocetirizine has a rapid and long-acting action, allowing once-a-day administration.
","Adult and children 12 years of age and older: The recommended dose is 5 mg once daily.
Children 6 to 11 years of age: The recommended dose is 2.5 mg (1/2 tablet or 1 teaspoon oral solution) once daily.
Children 6 months to 5 years of age: The recommended dose is 1.25 mg (1/2 teaspoon oral solution) once daily.
",,"Levocetirizine is not known to have any interactions with other drugs.
","Hypersensitivity to levocetirizine, cetirizine or its parent compound hydroxyzine. Patients with severe renal impairment (creatinine clearance: <10 ml/min) should not be administered levocetirizine.
","Generally, levocetirizine is well tolerated. However, a few side effects like headache, dry mouth, fatigue and skin rash have been reported rarely.
","Pregnancy Catagory B. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, levocetirizine should be used during pregnancy only if clearly needed. Since levocetirizine is excreted in breast milk it is not recommended for use by nursing mothers.
","Epileptic patients and patients at risk of convulsions. Renal impairment. Pregnancy and lactation.
","Pediatric use: The recommended dose for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in patients 6 months to 17 years of age is based on extrapolation of efficacy from adults 18 years of age and older.
Geriatric use: In clinical studies, each approved indication did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients.
Hepatic impairment: No dosage adjustment is required in patients with solely hepatic impairment.
Renal impairment:
+
+- Mild renal impairment (creatinine clearance: 50-80 ml/min): a dose of 2.5 mg once daily is recommended.
+- Moderate renal impairment (creatinine clearance: 30-50 ml/min): a dose of 2.5 mg once every other day is recommended.
+- Severe renal impairment (creatinine clearance: 10-30 ml/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended.
+- End-stage renal disease patients (creatinine clearance: <10 ml/min) and patients undergoing hemodialysis: should not receive Levocetirizine.
+
","No clinically relevant adverse events have been reported in case of overdose. However in the event of overdosage, symptomatic and supportive treatment is recommended.
",,,"Store at a temperature not exceeding 30°C in a dry place. Protect from light.
",12
+677,Levocarnitine,levocarnitine-677,https://medex.com.bd/attachments/3eIzkputMJ5vEchQr9TTO8VaPL2QXB/levocarnitine-prescribing-information,Drugs for muscular energy metabolism,Male infertility,"Levocarnitine is indicated in-
+
+- Chronic Fatigue Syndrome
+- Heart Diseases
+- Congestive Heart Failure
+- Kidney Disease
+- High Cholesterol
+- Intermittent Claudication
+- Dementia and memory impairment
+- Down Syndrome
+- Male infertility
+- Hyperthyroidism
+
","Drugs for muscular energy metabolism
","Levocarnitine is a naturally occurring substance required in mammalian energy metabolism. It has been shown to facilitate long-chain fatty acid entry into cellular mitochondria, thereby delivering substrate for oxidation and subsequent energy production. Fatty acids are utilized as an energy substrate in all tissues except the brain. In skeletal and cardiac muscle, fatty acids are the main substrate for energy production.
","Levocarnitine tablet-
+
+- Adults: 330 mg two or three times daily. Depending on clinical response.
+- Infants and children: 50 to 100 mg/kg/day in divided doses, with a maximum of 3 g/day. Dosage should begin at 50 mg/kg/day. The exact dosage will depend on clinical response.
+
+Levocarnitine solution (For oral use only. Not for parenteral use)-
+
+- Adults: The recommended dosage of Levocarnitine 100 ml solution is 10 to 30 ml/day. Higher doses should be administered with caution. Dosage should be started at 10 ml/day and be increased slowly while assessing tolerance and therapeutic response.
+- Infants and children: The recommended dosage of Levocarnitine 100 ml solution is 50 to 100 mg/kg/day. Dosage should be started at 50 mg/kg/day and be increased slowly to a maximum of 30 ml. /day. Levocarnitine oral solution can be given from 2-spoonful to 6-spoonful in divided dose as directed by physicians. Higher doses should be administered with caution.
+
+Note: Levocarnitine 100 ml solution may be consumed alone or dissolved in drink or other liquid food. Doses should be spaced evenly throughout the day preferably during or following meals and should be consumed slowly in order to maximize tolerance.
",,,,"Generally, Levocarnitine is well tolerated. However, few side effects including transient nausea and vomiting, abdominal cramps, and diarrhoea may occur.
","There is no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Levocarnitine supplementation in nursing mothers has not been specifically studied. In nursing mothers receiving levocarnitine, any risks to the child of excess carnitine intake need to be weighed against the benefits of levocarnitine supplementation to the mother. Consideration may be given to discontinuation of nursing or of levocarnitine treatment.
","Gastrointestinal reactions may result from a too rapid consumption of Levocarnitine. The safety and efficacy of oral levocarnitine has not been evaluated in patients with renal insufficiency. Chronic administration of high doses of oral levocarnitine in patients with severely compromised renal function or in ESRD patients on dialysis may result in accumulation of the potentially toxic metabolites, trimethylamine (TMA) and trimethylamine-N oxide (TMAO), since these metabolites are normally excreted in the urine.
",,"There have been no reports of toxicity from levocarnitine overdosage.
",,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",9
+676,Levobupivacaine Hydrochloride,levobupivacaine-hydrochloride-676,,Regional anesthesia,Surgical anaesthesia,"For the production of local or regional anesthesia for surgery and obstetrics, and for post-operative pain management
","Regional anesthesia
","Levobupivacaine is a long acting local anaesthetic of the amide type. It is the S-enantiomer of bupivacaine. It blocks nerve conduction in sensory and motor nerves mainly by interacting with voltage sensitive sodium channels on the cell membrane. It also interferes with impulse transmission and conduction in other tissues. Levobupivacaine is given as the hydrochloride for infiltration anaesthesia and regional nerve blocks including epidural block. It is contraindicated in obstetric paracervical block and IV regional anaesthesia (Bier's block). The 0.75% solution is also contraindicated for epidural blocks in obstetrics.
","Acute pain: Pain relief during labour: 15-50 mg (6-20 ml) of a 0.25% solution, to be given as a bolus dose; alternatively, dose may be given via continuous infusion at 5-12.5 mg (4-10 ml) per hr using 0.125% solution or 5-12.5 mg (8-20 ml) per hr using 0.0625% solution.
Postoperative pain: 10-25 mg (4-10 ml) per hr of a 0.25% solution, 12.5-18.75 mg (10-15 ml) per hr of a 0.125% solution or 12.5-18.75 mg (20-30 ml) per hr of a 0.0625% solution; dose may be given as an epidural infusion. Max: 150 mg/dose; 400 mg/day.
Peripheral nerve block: 2.5-150 mg or 1-2 mg/kg (0.4 ml/kg) of a 0.25 or 0.5% solution. Not to exceed 40 ml. Max: 150 mg/dose; 400 mg/day.
Surgical anaesthesia: Epidural block: 50-100 mg (10-20 ml) of a 0.5% solution or 75-150 mg (10-20 ml) of a 0.75% solution. Caesarean section: 75-150 mg (15-30 ml) of a 0.5% solution. Spinal block: 15 mg (3 ml) of a 0.5% solution. Max: 150 mg/dose; 400 mg/day.
Infiltration anaesthesia:
+
+- Adult: Up to 150 mg (60 ml) of a 0.25% solution. For peribulbar block in ophth procedures: 37.5-112.5 mg (5-15 ml) of a 0.75% solution. Max: 150 mg/dose; 400 mg/day.
+- Child: For ilioinguinal or iliohypogastric blocks in children <12 yr: 0.625-2.5 mg/kg (0.25-0.5 ml/kg) of a 0.25 or 0.5% solution.
+
",,"Plasma levels may be reduced when used with enzyme-inducing drugs such as rifampicin. Substrates for or inhibitors of CYP3A4 and CYP1A2 may affect the plasma levels of levobupivacaine.
","Not to be used in IV regional anesth (Bier's block) and paracervical block in obstetrics. Do not use 0.75% solution for epidural block in obstetrics. Hypovolaemia, complete heart block.
","CNS effects such as restlessness, anxiety, dizziness, confusion, respiratory depression and convulsions. Neuromuscular and skeletal weakness, blurred vision, pupillary constriction, tinnitus. Hypotension, bradycardia and CV collapse which may lead to cardiac arrest. Rarely, hypersensitivity reactions.
","Pregnancy Category B. Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
","Epilepsy, respiratory impairment, impaired cardiac conduction, bradycardia, severe shock, acute porphyria, myasthenia gravis, renal or hepatic impairment. Pregnancy, lactation. Reduce dose in elderly or debilitated patients. Resuscitative equipment should be available. Do not use solutions containing adrenaline for anesth in appendages. Do not use solutions containing preservatives for caudal or epidural block.
",,,,"When needed, dilutions should be made with normal saline.Not to be used in IV regional anesth (Bier's block) and paracervical block in obstetrics. Do not use 0.75% solution for epidural block in obstetrics. Hypovolaemia, complete heart block.
","To be used immediately after opening. After dilution in normal saline: Chemical and physical in-use stability at 20-22°C for 7 days.
",11
+1259,Levobunolol,levobunolol-1259,https://medex.com.bd/attachments/50xQ0R6aAhU97eF1QxXTSErad1b5dG/levobunolol-prescribing-information,Drugs for miotics and glaucoma,Open angle glaucoma,"Levobunolol ophthalmic solution has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma or ocular hypertension.
","Drugs for miotics and glaucoma
","Levobunolol is a nonselective β-adrenergic blocking agent. It causes the reduction of intraocular pressure by decreasing the production of aqueous humour.
","The recommended starting dose is one to two drops of Levobunolo ophthalmic solution 0.5% in the affected eye(s) once a day. Typical dosing with Levobunolol 0.25% is one to two drops twice daily. In patients with more severe or uncontrolled glaucoma, Levobunolo 0.5% can be administered b.i.d. As with any new medication, careful monitoring of patients is advised. Dosages above one drop of Levobunolol 0.5% b.i.d. are not generally more effective. If the patient's IOP is not at a satisfactory level on this regimen, concomitant therapy with dipivefrin and/or epinephrine, and/or pilocarpine and other miotics, and/or systemically administered carbonic anhydrase inhibitors, such as acetazolamide, can be instituted. Patients should not typically use two or more topical ophthalmic beta-adrenergic blocking agents simultaneously.
",,"Additive hypotensive effect with catecholamine-depleting drug (e.g. reserpine), Ca channel blockers, β-adrenergic blockers, digitalis glycosides, antiarrhythmics, guanethidine, parasympathomimetics. Mydriasis may occur when used with epinephrine.
","Levobunolol ophthalmic solution is contraindicated in those individuals with bronchial asthma, or with a history of bronchial asthma, or severe chronic obstructive pulmonary disease; sinus bradycardia; second and third degree atrioventricular block; overt cardiac failure; cardiogenic shock; or hypersensitivity to any component of these products.
","Common side effects are ocular stinging, burning, blepharoconjunctivitis, blepharitis, decreased visual acuity, band keratopathy, erythema, iridocyclitis, conjunctivitis and itching sensation; bradycardia, CVA, syncope, arrhythmia, heart block, hypotension, cerebral ischaemia, bronchospasm. Rarely, reduced corneal sensitivity and tearing.
","There are no adequate and well-controlled studies in pregnant women. Levobunolol ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether this drug is excreted in human milk. Systemic beta-blockers and topical timolol maleate are known to be excreted in human milk. Caution should be exercised when Levobunolol is administered to a nursing woman.
","Patients with diminished pulmonary function, nonallergic bronchospasm, inadequate cardiac function, DM, myasthenia gravis. May mask signs and symptoms of hypoglycaemia and hyperthyroidism. Avoid abrupt withdrawal as it may precipitate thyroid storm. Pregnancy and lactation.
","Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
","No data are available regarding overdosage in humans. Should accidental ocular overdosage occur, flush eye(s) with water or normal saline. If accidentally ingested, efforts to decrease further absorption may be appropriate (gastric lavage). The most common signs and symptoms to be expected with overdosage with administration of a systemic beta-adrenergic blocking agent are symptomatic bradycardia, hypotension, bronchospasm, and acute cardiac failure. Should these symptoms occur, discontinue Levobunolol therapy and initiate appropriate supportive therapy. The following supportive measures should be considered:
Symptomatic bradycardia: Use atropine sulfate intravenously in a dosage of 0.25 mg to 2 mg to induce vagal blockade. If bradycardia persists, intravenous isoproterenol hydrochloride should be administered cautiously. In refractory cases the use of a transvenous cardiac pacemaker should be considered.
Hypotension: Use sympathomimetic pressor drug therapy, such as dopamine, dobutamine or levarterenol. In refractory cases the use of glucagon hydrochloride may be useful.
Bronchospasm: Use isoproterenol hydrochloride. Additional therapy with aminophylline may be considered.
Acute cardiac failure: Conventional therapy with digitalis, diuretics and oxygen should be instituted immediately. In refractory cases the use of intravenous aminophylline is suggested. This may be followed, if necessary, by glucagon hydrochloride which may be useful.
Heart block (second or third degree): Use isoproterenol hydrochloride or a transvenous cardiac pacemaker.
",,,,11
+675,Levetiracetam,levetiracetam-675,https://medex.com.bd/attachments/0W8Ziic3xvs6tUanQHhgIxFsmoXUwu/levetiracetam-tablets-syrup-prescribing-information,Adjunct anti-epileptic drugs,Seizures,"Levetiracetam is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levetiracetam is indicated as adjunctive therapy-
+
+- in the treatment of partial-onset seizures with or without secondary generalization in adults, adolescents, children and infants from 1 month of age with epilepsy.
... Read more
Levetiracetam is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levetiracetam is indicated as adjunctive therapy-
+
+- in the treatment of partial-onset seizures with or without secondary generalization in adults, adolescents, children and infants from 1 month of age with epilepsy.
+- in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
+- in the treatment of primary generalized tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
+
","Adjunct anti-epileptic drugs
",,"Adults and adolescents from 16 years of age: The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks. The dose can be further increased by 250 mg twice daily every two weeks depending upon the clinical response. The maximum dose is 1500 mg twice daily.
Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more: The initial therapeutic dose is 500 mg twice daily. This dose can be started on the first day of treatment. Depending upon the clinical response and tolerability, the daily dose can be increased up to 1,500 mg twice daily. Dose changes can be made in 500 mg twice daily increases or decrease every two to four weeks.
Pediatric population: The tablet formulation is not adapted for use in infants and children under the age of 6 years. Oral solution is the preferred formulation for use in this population. In addition, the available dose strengths of the tablets are not appropriate for initial treatment in children weighing less than 25 kg, for patients unable to swallow tablets or for the administration of doses below 250 mg. In all of the above cases, oral solution should be used.
+
+- Monotherapy: The safety and efficacy of levetiracetam in children and adolescents below 16 years as monotherapy treatment have not been established.
+- Add-on therapy: Oral solution is the preferred formulation for use in infants and children under the age of 6 years. For children 6 years and above, oral solution should be used for doses under 250 mg, for doses not in multiples of 250 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets. The lowest effective dose should be used. The starting dose for a child or adolescent of 25 kg should be 250 mg twice daily with a maximum dose of 750 mg twice daily. Dosing for children 50 kg or greater is the same as in adults.
+- Add-on therapy: For infants aged from 1 month to less than 6 months: The oral solution is the formulation to use in infants.
+
","The flm-coated tablets must be taken orally, swallowed with a sufcient quantity of liquid and may be taken with or without food. The daily dose is administered in two equally divided doses.
","Antiepileptic medicinal products: Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not influence the serum concentrations of existing antiepileptic medicinal products (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these antiepileptic medicinal products did not influence the pharmacokinetics of levetiracetam.
Probenecid: Probenecid (500 mg four times daily), a renal tubular secretion blocking agent, has been shown to inhibit the renal clearance of the primary metabolite but not of levetiracetam. Nevertheless, the concentration of this metabolite remains low.
Methotrexate: Concomitant administration of levetiracetam and methotrexate has been reported to decrease methotrexate clearance, resulting in increased/prolonged blood methotrexate concentration to potentially toxic levels. Blood methotrexate and levetiracetam levels should be carefully monitored in patients treated concomitantly with the two drugs.
Laxatives: There have been isolated reports of decreased levetiracetam efficacy when the osmotic laxative macrogol has been concomitantly administered with oral levetiracetam. Therefore, macrogol should not be taken orally for one hour before and for one hour after taking levetiracetam.
Food and alcohol: The extent of absorption of levetiracetam was not altered by food, but the rate of absorption was slightly reduced. No data on the interaction of levetiracetam with alcohol are available.
","Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients.
","Most common adverse reactions (incidence ≥ 5% more than placebo) include:
+
+- Adult patients: somnolence, asthenia, infection and dizziness
+- Pediatric patients: fatigue, aggression, nasal congestion, decreased appetite, and irritability
+
","Levetiracetam is not recommended during pregnancy and in women of childbearing potential not using contraception unless clinically necessary. Levetiracetam is excreted in human breast milk. Therefore, breastfeeding is not recommended. However, if levetiracetam treatment is needed during breastfeeding, the benefit/risk of the treatment should be weighed considering the importance of breastfeeding. No impact on fertility was detected in animal studies. No clinical data are available, the potential risk for humans is unknown.
","Renal impairment: The administration of levetiracetam to patients with renal impairment may require dose adjustment. In patients with severely impaired hepatic function, assessment of renal function is recommended before dose selection.
Acute kidney injury: The use of levetiracetam has been very rarely associated with acute kidney injury with a time to onset ranging from a few days to several months.
Blood cell counts: Rare cases of decreased blood cell counts (neutropenia, agranulocytosis, leucopenia, thrombocytopenia and pancytopenia) have been described in association with levetiracetam administration, generally at the beginning of the treatment. Complete blood cell counts are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders.
Suicide: Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents (including levetiracetam). A meta-analysis of randomized placebo-controlled trials of anti-epileptic medicinal products has shown a small increased risk of suicidal thoughts and behaviour. The mechanism of this risk is not known. Therefore patients should be monitored for signs of depression and/or suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of depression and/or suicidal ideation or behaviour emerge.
Paediatric population: The tablet formulation is not adapted for use in infants and children under the age of 6 years. Available data in children did not suggest an impact on growth and puberty. However, long term effects on learning, intelligence, growth, endocrine function, puberty and childbearing potential in children remain unknown.
","Elderly (65 years and older): Adjustment of the dose is recommended in elderly patients with compromised renal function.
Renal impairment: The daily dose must be individualized according to renal function.
Hepatic impairment: No dose adjustment is needed in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the creatinine clearance may underestimate renal insufficiency. Therefore a 50 % reduction of the daily maintenance dose is recommended when the creatinine clearance is < 60 ml/min.
","Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with levetiracetam overdoses. After an acute overdose, the stomach may be emptied by gastric lavage or by induction of emesis. There is no specifc antidote for levetiracetam. Treatment of an overdose will be symptomatic and may include haemodialysis. The dialyser extraction efficiency is 60 % for levetiracetam and 74% for the primary metabolite.
",,,"Store at a cool temperature (not exceeding 25°C) and dry place, protected from light.
",12
+674,Levamisole,levamisole-674,,Anthelmintic,Helminthiasis,"Levamisole is a fast acting drug which acts on nematode nerve ganglia paralysing the worm’s musculature within seconds of contact. Unable to maintain their position, the worms are then ejected by normal peristaltic movement, usually within 24 hours of levamisole administration. Although it is ... Read more
Levamisole is a fast acting drug which acts on nematode nerve ganglia paralysing the worm’s musculature within seconds of contact. Unable to maintain their position, the worms are then ejected by normal peristaltic movement, usually within 24 hours of levamisole administration. Although it is certain that levamisole primarily influences the neuromuscular system of nematodes, it is possible that in some helminthes the inhibition of the fumarate reductase system contributes to the anthelmintic efficacy of levamisole. Levamisole is indicated for the treatment of infections by the following gastrointestinal worm
species:
+
+- Ascaris lumbricoides: Roundworm
+- Necator americanus: Hookworm
+- Ancylostoma duodenal: Hookworm
+- E nterobius vermicularis: Pinworm
+- Trichuris trichuria: Whipworm
+- Strongyloides stercoralis: Threadworm
+- Trichostrongylus colubriformis
+
","Anthelmintic
","Levamisole is the active laevo-isomer of tetramisole. It works by paralysing susceptible intestinal worms which are then excreted from the intestines. Levamisole also enhances cellular immune responses in humans.
","The following doses of Levamisole are given as a single administration, preferably after a light meal.
+
+- Age 1-4 year: 1 Tablets or 5 ml Syrup
+- Age 5-15 year: 2 Tablets or 10 ml Syrup
+- Age 16 year and over: 3 Tablets or 15 ml Syrup
+
+In cases of severe hookworm infection it is suggested that a second standard dose be given one or seven days after the first, whichever timing is feasible.
",,"May increase toxicity of phenytoin. Increases bioavailability of ivermectin; decreases bioavailability of albendazole. Alcohol causes disulfiram-like reaction.
","There is no absolute contra-indication to the use of Levamisole
","Side-effects are infrequent. They are usually mild and transient and include nausea, vomiting, abdominal pain, giddiness(dizziness) and headache. An encephalopathylike syndrome has been reported to have occurred in a few patients two or three weeks after treatment.
","Although studies in animals have shown that Levamisole produces no teratogenic effects, current medical practice requires that the benefits of any drug used during pregnancy should be weighed against the possible dangers.
","Effect on ability to drive or operate machinery: There is no evidence to suggest that Levamisole , used for anthelmintic purpose, will produce sedation. Mild and transient giddiness is an infrequent side-effect of treatment. No precautions are suggested concerning the ability to drive or operate machinery.
In case of concurrent microfilaraemia transient fever may occur.
",,"Counter possible anticholinesterase activity with e.g. atropine. Control blood pressure and respiration . Do not use sedatives.
",,,"Tablet: Store in room temperature and protect from moisture.
Syrup: Store in room temperature and protect from light.
",11
+673,Leuprorelin Acetate,leuprorelin-acetate-673,,Drugs acting on the Uterus,Uterine fibroids,"For treatment of prostate cancer, endometriosis, uterine fibroids and premature puberty
","Drugs acting on the Uterus, Drugs affecting (inhibiting) gonadotrophin
","Leuprorelin is a gonadotropin-releasing hormone (GnRH) analogue. Following an initial stimulation of gonadotrophins, continuous admin of Leuprorelin leads to down regulation of GnRH receptors and subsequently reduces pituitary gonadotrophin secretion. Reduced gonadotrophin levels lead to inhibition of sex hormone (testosterone and oestrogen) production. Within 2-4 wk after treatment initiation, testosterone levels in male may be reduced to below castrate threshold.
","Adult: Palliative treatment of advanced prostate cancer: 1 mg as single daily dose by SC inj. Depot preparations may be given by IM or SC route, dosage and route may differ between different brands and countries. In the UK: As depot preparations: 3.75 mg every mth as single IM/SC inj; or 11.25 mg every 3 mth via SC inj. In the US: As depot preparations: 7.5 mg every mth, or 22.5 mg every 3 mth, or 30 mg every 4 mth via IM/SC inj depending on the preparations; or 45 mg every 6 mth via SC inj.
Endometriosis: As depot preparations: 3.75 mg every mth given as a single IM/SC inj or 11.25 mg every 3 mth as IM depot Inj. Initiate treatment during the 1st 5 days of menstrual cycle up to 6 mth. May be used with norethindrone acetate 5 mg daily for initial management of endometriosis and for management of recurrence symptoms. Duration of retreatment: Should not exceed one additional 6 mth course.
Uterine fibroids: As depot preparations: In combination with iron therapy for women with anaemia due to uterine fibroids, 3.75 mg every mth given as a single IM/SC inj or 11.25 mg every 3 mth as IM Inj. Treatment duration: Usually up to 3 mth.
Preparation for intrauterine surgery: Endometrial preparation prior to intrauterine surgery: As depot preparations: 3.75 mg as a single inj via IM/SC given 5-6 wk before the procedure; therapy should be initiated during days 3-5 of the menstrual cycle.
Child: Precocious puberty: As aqueous soln inj: Initial: 50 mcg/kg daily by SC inj, may be titrated upwards by 10 mcg/kg/day if total down-regulation is not achieved. As depot preparations: Initial: 0.3 mg/kg/dose (minimum dose: 7.5 mg) given every 4 wk via IM inj; which equates to children ≤25 kg: 7.5 mg; >25-37.5 kg: 11.25 mg and >37.5 kg: 15 mg given every 4 wk. Maintenance: May titrate dose upwards in steps of 3.75 mg every 4 wk if down-regulation is not achieved. Consider discontinuing therapy before age 11 (females) and age 12 (males).
",,,"Pregnancy, lactation; hypersensitivity to GnRH, GnRH agonist analogs or product excipients; undiagnosed abnormal vaginal bleeding.
","Treatment of precocious puberty: General pain, headache, acne, rash, seborrhoea, emotional lability, vaginitis, vaginal bleeding vaginal discharge
Treatment of prostate cancer: Transient worsening of signs and symptoms (usually increase in bone pain), ECG changes, high blood pressure, peripheral oedema, anorexia, constipation, nausea, vomiting, anaemia, myalgia, dizziness, general pain, headache, insomnia or sleep disorder, sinus congestion, urinary frequency/urgency, haematuria, UTI, asthaenia, physiological effects of decreased testosterone (e.g. gynaecomastia, breast tenderness, decreased testicular size, hot flashes, impotence).
Treatment of endometriosis and uterine fibroids treatment: General pain, headache, asthaenia, nausea, vomiting, oedema, weight changes, acne, hirsutism, dizziness, insomnia, sleep disturbance, paraesthesias, skin reactions, effects of hypoestrogenism such as hot flashes, joint disorder, myalgia, decreased libido, depression, emotional lability, nervousness, breast tenderness, vaginitis.
","Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
","Vary inj site periodically. May cause transient elevation of testosterone levels during the first 1-2 wk, which may lead to worsening or onset of new symptoms (e.g. bone pain, neuropathy, haematuria) in prostate cancer patients. Ureteral obstruction and spinal cord compression have been reported; closely monitor patients with urinary obstruction and/or metastatic vertebral lesion. Leuprorelin is associated with increased risk of diabetes and certain CV diseases (heart attack, sudden cardiac death, stroke) when used in men for treatment of prostate cancer. For prostate cancer, monitor response by testosterone and prostate-specific antigen (PSA) levels. For precocious puberty in children, monitor response by GnRH stimulation test sex steroid levels 1-2 month after treatment initiation. Leuprorelin usually inhibits ovulation and stops menstruation in women, but does not incur contraception, non-hormonal contraception should be used as pregnancy is contraindicated. May cause adverse reactions associated with hypoestrogenism and loss in bone density.
",,,,,,8
+672,Letrozole,letrozole-672,https://medex.com.bd/attachments/KGnj1Df4raJG0jVtD4YeGf9wlbnupJ/letrozole-prescribing-information,Hormonal Chemotherapy,Stimulate ovulation,"Letrozole is indicated for the first-line treatment of advanced/metastatic breast cancer (hormone receptor positive or receptor status unknown) in post-menopausal women.
","Hormonal Chemotherapy
","Mechanism of Action: Letrozole is a potent and highly specific nonsteroidal aromatase inhibitor. It inhibits the aromatase enzyme by competitively binding to the haem of the cytochrome P450 subunit of the enzyme, resulting in a reduction of estrogen biosynthesis in all tissues. Letrozole exerts its antitumor effect by depriving estrogen-dependent breast cancer cells of their growth stimulus. In postmenopausal women, estrogens are derived mainly from the action of the aromatase enzyme, which coverts adrenal androgens primarily androstenedione and testosterone-to oestrone (E1) and oestradiol (E2). The suppression of estrogen biosynthesis in the peripheral tissues and the malignant tissues can be achieved by specifically inhibiting the aromatase enzyme.
In healthy postmenopausal women, single doses of 0.1, 0.5 and 2.5mg letrozole suppress serum oestrone and oestradiol by 75-78% and 78% from baseline respectively. Maximum suppression is achieved in 48-78 hours. In post-menopausal patients, with advanced breast cancer, daily doses of 0.1 to 5mg suppress plasma concentration of oestradiol, oestrone, and oestrone sulphate by 78-95% from baseline in all patients treated. Letrozole had no effect on plasma androgen concentrations (androstenedione and testosterone) among healthy postmenopausal women after single doses of 0.1, 0.5 and 2.5mg indicating that the blockade of estrogen biosynthesis does not lead to accumulation of androgenic precursors. Impairment of adrenal steroidogenesis has not been observed.
Pharmacokinetics: Letrozole is rapidly and completely absorbed from the gastrointestinal tract (absolute bioavailability 99.9%). Food slightly decreases the rate of absorption, but the extent of absorption remains unchanged. The minor effect of the absorption rate is not considered to be of clinical relevance and therefore letrozole may be taken after, with or before food. Plasma protein binding of letrozole is approximately 60%, mainly to albumin (55%). The concentration of letrozole in erythrocytes is about 80% of that in plasma. Metabolic clearance to a pharmacologically inactive carbinol metabolite is the major elimination pathway of letrozole but is relatively slow when compared to hepatic blood flow. The cytochrome P450 isoenzymes 3A4 and 2A6 were found to be capable of converting letrozole to this metabolite in vitro but their individual contributions to letrozole metabolism in vivo have not been established. The apparent terminal elimination half-life in plasma is about 2 days. After daily administration of 2.5mg of letrozole, steady-state levels are reached within 2 to 6 weeks.
","The recommended dose of Letrozole is 2.5 mg once daily. Treatment with Letrozole should continue as long as tumor response is seen. The drug should be discontinued if tumor stops responding as judged by tumor progression. For elderly patients, no modification of the normal adult dosage regimen is necessary. No dosage adjustment is required for patients with mild to moderate hepatic impairment or renal impairment.
",,"Clinical interaction studies with cimetidine and warfarin indicated that the co-administration of letrozole with these drugs does not result in clinically significant drug reactions, even through cimetidine is a known inhibitor of one of the cytochrome P450 isoenzymes capable of metabolising letrozole in vitro.
","Letrozole is contraindicated in known or suspected hypersensitivity to letrozole, other aromatase inhibitors, or to any of their ingredients. It is contraindicated during pregnancy, lactation and in pre-menopausal women. It is also contraindicated in severe hepatic dysfunction.
","Adverse events associated with letrozole are generally mild to moderate and rarely severe enough to require discontinuation. Many can be attributed to either the underlying disease or the normal pharmacological consequence of oestrogen deprivation (hot flushes, hair thinning). The most frequently reported adverse events are musculoskeletal pain, arthralgia, headache, fatigue, nausea, dyspnoea, peripheral oedema, coughing, constipation, vomiting, chest pain, viral infection, diarrhoea, rash, abdominal pain, dyspepsia and anorexia. Dizziness, weight increase and pruritus are less commonly seen.
","Oral administration of letrozole in pregnant rats resulted in teratogenicity and maternal toxicity at 0.03 mg/kg. Embryotoxicity and foetotoxicity were seen at doses >0.003 mg/kg and there was an increase in the incidence of foetal malformation among the animals treated. However, there are no adequate and well-controlled studies of letrozole in pregnant women and its use in these patients is not recommended. It is not known whether letrozole is excreted in human milk. Because many drugs are excreted in human milk, letrozole should not be administered to a nursing woman.
","In breast cancer patients with moderate hepatic dysfunction, no dosage adjustment is necessary, but caution is recommended since letrozole elimination depends mainly on intrinsic metabolic clearance. Renal impairment (calculated creatinine clearance: 20 to 50 ml/min) did not affect steady-state plasma letrozole concentration at a dose of 2.5 mg or 5 mg. Hence, no dose adjustment is necessary for such renal function impairment. It is anticipated that letrozole could be removed from blood by dialysis since it is weakly bound to plasma proteins. The potential risks and benefits to such patients should be considered carefully before prescribing letrozole. In some cases, fatigue and dizziness have been observed with the use of letrozole. Patients should therefore, be advised that their physical and/or mental abilities required for operating machinery or driving a car may be impaired.
",,"There is no clinical experience of overdosage. There is no specific antidote to letrozole. Since letrozole is not highly protein-bound, dialysis may be helpful. Emesis may be induced if the patient is alert. In general, supportive care and frequent monitoring of vital signs is appropriate.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+671,Lercanidipine Hydrochloride,lercanidipine-hydrochloride-671,https://medex.com.bd/attachments/R9kcrTiyedUN0HdcgqdjR6aZFawJzq/lercanidipine-hydrochloride-prescribing-information,Calcium-channel blockers,Mild to moderate hypertension,"Lercanidipine is indicated for the treatment of mild to moderate essential hypertension.
","Calcium-channel blockers
","Lercanidipine is a selective calcium channel blocker of the dihydropyridine group and it inhibits the transmembrane influx of calcium into smooth muscle. The mechanism of its antihypertensive action is due to a direct relaxant effect on vascular smooth muscle, thus lowering total peripheral resistance. Lercanidipine is endowed with a prolonged antihypertensive activity because of its high membrane partition coefficient and is devoid of negative inotropic effects due to its high vascular selectivity.
","Use in the elderly: The recommended dosage is 10 mg orally once a day at least 15 minutes before meals; the dose may be increased to 20 mg depending on the individual patient's response. It may take about 2 weeks before the maximal antihypertensive effect is apparent.
Some individuals, not adequately controlled on a single antihypertensive agent, may benefit from the addition of Lercanidipine to therapy with a beta-adrenoceptor blocking drug (atenolol), a diuretic (hydrochlorothiazide) or an ACE inhibitor (ramiprii).
Use in children: Since there is no clinical data in patients under the age of 18 years, use in children is not currently recommended.
Use in renal or hepatic dysfunction: Special care should be exercised in patients with mild to moderate renal or hepatic dysfunction. Dosage above 20 mg daily must be approached with caution. Lercanidipine is not recommended for use in patients with severe hepatic or renal dysfunction.
",,"Concomitant treatment of Lercanidipine with cyclosporin, phenytoin, carbamazepine, rifampicin, ketoconazole, itraconazole, ritonavir, erythromycin, troleandomycin, and midazolam should be avoided. Caution should be exercised when Lercanidipine is co-prescribed with astemizole, amiodarone, quinidine, cimetidine, metoprolol and simvastatin.
","Lercanidipine is contraindicated in patients with left ventricular outflow tract obstruction, untreated congestive cardiac failure, unstable angina pectoris, within 1 month of a myocardial infarction and known hypersensitivity to any dihydropyridine. Lercanidipine should not be taken with grapefruit juice.
","Treatment with Lercanidipine is generally well tolerated. The most common side effects are related to the vasodilatory properties of Lercanidipine such as flushing, peripheral edema, headache, dizziness and asthenia. Other side effects, which occurred in less than 1% of patients include fatigue; Gl disturbances such as dyspepsia, nausea, vomiting, epigastric pain and diarrhea, polyurea, rash, somnolence and myalgia.
","Since there is no clinical data with Lercanidipine in pregnancy, it should not be administered during pregnancy or to woman with child bearing potential unless effective contraception is used. Lercanidipine is highly lipophilic and distribution in milk may be expected. Therefore, it should not be administered to nursing mother.
","Special care should be exercised when Lercanidipine is used in patients with sick sinus syndrome, left ventricular dysfunction and ischaemic heart disease.
",,"There is no data with Lercanidipine overdosage. As with other dihydropyridines, overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and reflex tachycardia. Since the drug is highly lipophilic, it is most probable that plasma levels are no guide to the duration of the period of risk and dialysis may not be effective.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+1389,Lenvatinib Mesylate,lenvatinib-mesylate-1389,https://medex.com.bd/attachments/EN6J7gYuV4IzjevjW9THMg5dDhHaow/lenvatinib-mesylate-prescribing-information,,,"Lenvatinib is a kinase inhibitor that is indicated:
+
+- Differentiated Thyroid Cancer: Lenvatinib is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).
+- Renal Cell Carcinoma ... Read more
Lenvatinib is a kinase inhibitor that is indicated:
+
+- Differentiated Thyroid Cancer: Lenvatinib is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).
+- Renal Cell Carcinoma: Lenvatinib is indicated in combination with Everolimus for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy.
+- Hepatocellular Carcinoma: Lenvatinib is indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).
+- Endometrial Carcinoma: Lenvatinib, in combination with Pembrolizumab, is indicated for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation.
+
",,"Lenvatinib is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). Lenvatinib inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4; platelet-derived growth factor receptor alpha (PDGFR ), KIT, and RET. Lenvatinib also exhibited antiproliferative activity in hepatocellular carcinoma cell lines dependent on activated FGFR signaling with concurrent inhibition of FGF-receptor substrate 2 (FRS2 ) phosphorylation.
Absorption: The time to peak plasma concentration (Tmax) typically occurred from 1 to 4 hours post-dose. Administration with a high-fat meal (approximately 900 calories of which approximately 55% were from fat, 15% from protein, and 30% from carbohydrates) did not affect the extent of absorption, but decreased the rate of absorption and delayed the median Tmax from 2 hours to 4 hours.
Distribution: In vitro binding of Lenvatinib to human plasma proteins ranged from 98% to 99% at concentrations of 0.3 to 30 μg/mL. The blood-to-plasma concentration ratio ranged from 0.59 to 0.61 at concentrations of 0.1 to 10 μg/mL in vitro.
Metabolism: The main metabolic pathways for Lenvatinib in humans were identified as enzymatic (CYP3A and aldehyde oxidase) and non-enzymatic processes. Excretion: Ten days after a single administration of radiolabeled Lenvatinib, approximately 64% and 25% of the radiolabel were eliminated in the feces and urine, respectively.
Elimination: The terminal elimination half-life of Lenvatinib was approximately 28 hours.
","Important Dosage Information: The dose reduction is needed for certain patients with renal or hepatic impairment. Lenvatinib should be taken once daily, with or without food, at the same time each day. If a dose is missed and cannot be taken within 12 hours, skip that dose and take the next dose at the usual time of administration.
Recommended Dosage for Differentiated Thyroid Cancer (DTC): The recommended dosage of Lenvatinib is 24 mg orally once daily until disease progression or until unacceptable toxicity.
Recommended Dosage for Renal Cell Carcinoma (RCC): The recommended dosage of Lenvatinib is 18 mg in combination with 5 mg Everolimus orally once daily until disease progression or until unacceptable toxicity.
Recommended Dosage for Hepatocellular Carcinoma (HCC): The recommended dosage of Lenvatinib is based on actual body weight: 12 mg for patients greater than or equal to 60 kg or 8 mg for patients less than 60 kg. Lenvatinib should be taken orally once daily until disease progression or until unacceptable toxicity.
Recommended Dosage for Endometrial Carcinoma: The recommended dosage of Lenvatinib is 20 mg orally once daily, in combination with Pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks, until unacceptable toxicity or disease progression.
","Lenvatinib capsules can be swallowed whole or dissolved in a small glass of liquid. To dissolve in liquid, put capsules into 1 tablespoon of water or apple juice without breaking or crushing the capsules. Leave the capsules in the water or apple juice for at least 10 minutes. Stir for at least 3 minutes. After drinking the mixture, add 1 tablespoon of water or apple juice to the glass, swirl the contents a few times and swallow the water or apple juice.
","Drugs That Prolong the QT Interval: Lenvatinib has been reported to prolong the QT/QTc interval. Avoid coadministration of Lenvatinib with medicinal products with a known potential to prolong the QT/QTc interval.
","It is contraindicated in patients with known hypersensitivity to Lenvatinib or to any component of the formulation.
","Hypertension, cardiac dysfunction, arterial thromboembolic events, hepatotoxicity, renal failure and impairment, proteinuria, diarrhea, fistula formation and gastrointestinal perforation, QT Interval Prolongation, hypocalcemia, reversible posterior leukoencephalopathy syndrome, hemorrhagic events, impairment of thyroid stimulating hormone suppression/thyroid dysfunction, wound healing complications.
","Use in Pregnancy: Based on the mechanism of action, Lenvatinib can cause embryo-fetal harm when administered to a pregnant female. Pregnant women should be advised of the potential risk to a fetus. Females of reproductive potential should be advised to use effective contraception during treatment with Lenvatinib and for at least 30 days after the last dose.
Use in Lactation: It is not known whether Lenvatinib is present in human milk. Because of the potential for serious adverse reactions in breastfed infants, women should be advised to discontinue breastfeeding during treatment with Lenvatinib and for at least 1 week after the last dose.
","Hypertension: Control blood pressure prior to initiating Lenvatinib. Monitor blood pressure after 1 week, then every 2 weeks for the first 2 months, and then at least monthly thereafter during treatment. Withhold and resume at a reduced dose when hypertension is controlled or permanently discontinue Lenvatinib is based on severity.
Cardiac Dysfunction: Serious and fatal cardiac dysfunction can occur with Lenvatinib. Monitor patients for clinical symptoms or signs of cardiac dysfunction. Withhold and resume at a reduced dose upon recovery or permanently discontinue Lenvatinib based on severity.
Arterial Thromboembolic Events: Permanently discontinue Lenvatinib following an arterial thrombotic event. The safety of resuming Lenvatinib after an arterial thromboembolic event has not been established and Lenvatinib has not been studied in patients who have had an arterial thromboembolic event within the previous 6 months.
Hepatotoxicity: Monitor liver function prior to initiating Lenvatinib, then every 2 weeks for the first 2 months, and at least monthly thereafter during treatment. Monitor patients with HCC closely for signs of hepatic failure, including hepatic encephalopathy. Withhold and resume at a reduced dose upon recovery or permanently discontinue Lenvatinib based on severity.
Renal Failure or Impairment: Withhold and resume at a reduced dose upon recovery or permanently discontinue Lenvatinib for renal failure or impairment based on severity.
Proteinuria: Monitor for proteinuria prior to initiating Lenvatinib and periodically during treatment. If urine dipstick proteinuria greater than or equal to 2+ is detected, obtain a 24-hour urine protein. Withhold and resume at a reduced dose upon recovery or permanently discontinue Lenvatinib based on severity.
Diarrhea: Diarrhea was the most frequent cause of dose interruption/reduction and diarrhea recurred despite dose reduction. Promptly initiate management of diarrhea. Withhold and resume at a reduced dose upon recovery or permanently discontinue Lenvatinib based on severity.
Fistula Formation and Gastrointestinal Perforation: Permanently discontinue Lenvatinib in patients who develop gastrointestinal perforation of any severity or Grade 3 or 4 fistula.
QT Interval Prolongation: Monitor and correct electrolyte abnormalities at baseline and periodically during treatment. Monitor electrocardiograms in patients with congenital long QT syndrome, congestive heart failure, bradyarrhythmias, or those who are taking drugs known to prolong the QT interval, including Class Ia and III antiarrhythmics. Withhold and resume at a reduced dose of Lenvatinib upon recovery based on severity.
Hypocalcemia: Hypocalcemia improved or resolved following calcium supplementation, with or without dose interruption or dose reduction.
Reversible Posterior Leukoencephalopathy Syndrome: Withhold and resume at a reduced dose upon recovery or permanently discontinue Lenvatinib depending on severity and persistence of neurologic symptoms.
Hemorrhagic Events: Consider the risk of severe or fatal hemorrhage associated with tumor invasion or infiltration of major blood vessels (e.g. carotid artery). Withhold and resume at reduced dose upon recovery or permanently discontinue Lenvatinib based on the severity.
Impairment of Thyroid Stimulating Hormone Suppression/Thyroid Dysfunction: Monitor thyroid function prior to initiating Lenvatinib and at least monthly during treatment. Treat hypothyroidism according to standard medical practice.
Wound Healing Complications: Wound healing complications, including fistula formation and wound dehiscence, can occur with Lenvatinib. Withhold Lenvatinib for at least 6 days prior to scheduled surgery. Resume Lenvatinib after surgery based on clinical judgment of adequate wound healing. Permanently discontinue Lenvatinib in patients with wound healing complications.
","Dosage Modifications for Severe Renal Impairment: The recommended dosage of Lenvatinib for patients with DTC, RCC, or endometrial carcinoma and severe renal impairment (creatinine clearance less than 30 mL/min calculated by Cockcroft-Gault equation using actual body weight) is:
+
+- Differentiated thyroid cancer: 14 mg orally once daily
+- Renal cell carcinoma: 10 mg orally once daily
+- Endometrial carcinoma: 10 mg orally once daily
+
+
Dosage Modifications for Severe Hepatic Impairment: The recommended dosage of Lenvatinib for patients with DTC, RCC, or endometrial carcinoma and severe hepatic impairment (Child-Pugh C) is:
+
+- Differentiated thyroid cancer: 14 mg taken orally once daily
+- Renal cell carcinoma: 10 mg taken orally once daily
+- Endometrial carcinoma: 10 mg orally once daily Or as directed by the registered physician.
+
+
Pediatric Use: The safety and effectiveness in pediatric patients have not been established.
","Due to the high plasma protein binding, Lenvatinib is not expected to be dialyzable. Death due to multiorgan dysfunction occurred in a patient who received a single dose of Lenvatinib 120 mg orally.
",,,"Store below 30°C in a dry place. Protect from light. Keep out of the reach of children.
",12
+670,Lenograstim,lenograstim-670,https://medex.com.bd/attachments/8AYJlOODP5nfnDB35wgUhG7ZxgGFUK/lenograstim-prescribing-information,Haematopoietic Agents,Neutropenia,"The drug is used to reduce the risk of life-threatening infection in patients with neutropenia, particularly after cytotoxic chemotherapy. Lenograstim is indicated as a treatment to reduce the duration of neutropenia and the severity of infections in patients with non-myeloid malignancy who have undergone ... Read more
The drug is used to reduce the risk of life-threatening infection in patients with neutropenia, particularly after cytotoxic chemotherapy. Lenograstim is indicated as a treatment to reduce the duration of neutropenia and the severity of infections in patients with non-myeloid malignancy who have undergone autologous or allogeneic bone marrow transplantation, or treatment with established cytotoxic chemotherapy and in addition to reduce the incidence of infection associated with established cytotoxic chemotherapy. Lenograstim is also indicated to mobilise peripheral blood progenitor cells (PBPCs) with Lenograstim alone, or after myelosuppressive chemotherapy, in order to accelerate haematopoietic recovery by infusion of such cells, after myelosuppressive or myeloablative therapy. Lenograstim is also indicated to accelerate the engraftment of these cells after their reinfusion.
","Haematopoietic Agents
","Lenograstim is the glycosylated recombinant form of human granulocyte colony stimulating factor. Lenograstim accelerates neutrophil recovery significantly after chemotherapy, with beneficial effects on clinical end-points such as incidence of laboratory-confirmed infection and length of hospital stay. Chemotherapy dose intensity has also been increased in patients receiving lenograstim, notably those with breast or small cell lung cancer, although improvements in tumour response and survival have not been demonstrated. Lenograstim also assists neutrophil recovery in patients undergoing bone marrow transplantation, and stimulates the production of peripheral blood stem cells (PBSCs) for autologous transfusion after aggressive chemotherapy.
","Intravenous-Neutropenia following bone marrow transplantation:
+
+- Adult: 19.2 million IU/m2 or 150 mcg/m2 daily by IV infusion started the day after transplantation for a maximum of 28 consecutive days.
+- Child: >2 yr: 19.2 million IU/m2 or 150 mcg/m2 daily by IV infusion started the day after transplantation for a maximum of 28 consecutive days.
+
+
Subcutaneous-Mobilisation of peripheral blood progenitor cells for autologous peripheral blood stem cell transplantation:
+
+- Adult: As monotherapy: 1.28 million IU/kg or 10 mcg/kg daily for 4-6 days (5-6 days in healthy donors). Following adjunctive myelosuppressive chemotherapy: 19.2 million IU/m2 or 150 mcg/m2 daily, started the day after completion of chemotherapy for a maximum of 28 consecutive days.
+
+
Subcutaneous-Chemotherapy-induced neutropenia:
+
+- Adult: 19.2 million IU/m2 or 150 mcg/m2 daily, start the day after completion of chemotherapy for a maximum of 28 consecutive days.
+
",,"Increased risk of myelosuppression with myelosuppressive antineoplastic agents; increased pulmonary toxicity with bleomycin and cyclophosphamide.
","Myeloid malignancies. Not to be used for 24 hr before or after cytotoxic chemotherapy.
","Musculoskeletal pain, bone pain, splenic enlargement, nausea, fever, thrombocytopenia, anaemia, epistaxis, headache, diarrhoea, dysuria, osteoporosis, cutaneous vasculitis, anorexia, Sweet's syndrome, toxic epidermal necrolysis.
","Pregnancy category is not classified.
","Premalignant or malignant myeloid condition; sickle-cell disease; osteoporotic bone disease; signs of pulmonary infiltrates (withdraw treatment). Monitor CBC during therapy. Pregnancy and lactation.
",,,,,"Should be stored in cool and dry place
",10
+669,Lenalidomide,lenalidomide-669,https://medex.com.bd/attachments/WTaS2s9mWs4yOckjF1DZnR4BVbnY2j/lenalidomide-prescribing-information,,,"Multiple Myeloma: Lenalidomide in combination with Dexamethasone is indicated for the treatment of adult patients with multiple myeloma (MM). Lenalidomide is indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT) ... Read more
Multiple Myeloma: Lenalidomide in combination with Dexamethasone is indicated for the treatment of adult patients with multiple myeloma (MM). Lenalidomide is indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT).
Myelodysplastic Syndromes: Lenalidomide is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
Mantle Cell Lymphoma: Lenalidomide is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included Bortezomib.
Follicular Lymphoma: Lenalidomide in combination with a Rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL).
Marginal Zone Lymphoma: Lenalidomide in combination with a Rituximab product, is indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL).
Limitations of Use: Lenalidomide is not indicated and is not recommended for the treatment of patients with CLL outside of controlled clinical trials.
",,"Lenalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties. Cellular activities of Lenalidomide are mediated through its target cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex. In vitro, in the presence of drug, substrate proteins (including Aiolos, Ikaros, and CK1α) are targeted for ubiquitination and subsequent degradation leading to direct cytotoxic and immunomodulatory effects. Lenalidomide inhibits proliferation and induces apoptosis of certain hematopoietic tumor cells including MM, mantle cell lymphoma, and del (5q) myelodysplastic syndromes in vitro. Lenalidomide causes a delay in tumor growth in some in vivo nonclinical hematopoietic tumor models including MM. Immunomodulatory properties of Lenalidomide include increased number and activation of T cells and natural killer (NK) cells leading to direct and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) via increased secretion of interleukin-2 and interferon-gamma, increased numbers of NKT cells, and inhibition of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes. In MM cells, the combination of Lenalidomide and Dxamethasone synergizes the inhibition of cell proliferation and the induction of apoptosis.
Absorption: Lenalidomide is rapidly absorbed following oral administration. Following single and multiple doses of Lenalidomide in patients with MM or MDS, the maximum plasma concentrations occurred between 0.5 and 6 hours post-dose. The single and multiple dose pharmacokinetic disposition of Lenalidomide is linear with AUC and Cmax values increasing proportionally with dose. Multiple doses of Lenalidomide at the recommended dosage does not result in drug accumulation. Administration of a single 25 mg dose of Lenalidomide with a high-fat meal in healthy subjects reduces the extent of absorption, with an approximate 20% decrease in AUC and 50% decrease in Cmax. In the trials where the efficacy and safety were established for Lenalidomide, the drug was administered without regard to food intake. Lenalidomide can be administered with or without food. The oral absorption rate of Lenalidomide in patients with MCL is similar to that observed in patients with MM or MDS.
Distribution: In vitro [14 C]-Lenalidomide binding to plasma proteins is approximately 30%. Lenalidomide is present in semen at 2 hours (1379 ng/ejaculate) and 24 hours (35 ng/ejaculate) after the administration of Lenalidomide 25 mg daily.
Elimination: The mean half-life of Lenalidomide is 3 hours in healthy subjects and 3 to 5 hours in patients with MM, MDS or MCL.
Metabolism: Lenalidomide undergoes limited metabolism. Unchanged Lenalidomide is the predominant circulating component in humans. Two identified metabolites are 5¬ Hydroxy-Lenalidomide and N-Acetyl Lenalidomide; each constitutes less than 5% of parent levels in circulation.
Excretion: Elimination is primarily renal. Following a single oral administration of [14 C]-Lenalidomide 25 mg to healthy subjects, approximately 90% and 4% of the radioactive dose was eliminated within ten days in urine and feces, respectively. Approximately 82% of the radioactive dose was excreted as Lenalidomide in the urine within 24 hours. Hydroxy-Lenalidomide and N-Acetyl-Lenalidomide represented 4.6% and 1.8% of the excreted dose, respectively. The renal clearance of Lenalidomide exceeds the glomerular filtration rate.
","Lenalidomide Combination Therapy: The recommended starting dose of Lenalidomide is 25 mg orally once daily on Days 1-21 of repeated 28-day cycles in combination with Dexamethasone. For patients greater than 75 years old, the starting dose of Dexamethasone may be reduced. Treatment should be continued until disease progression or unacceptable toxicity. In patients who are not eligible for auto-HSCT, treatment should continue until disease progression or unacceptable toxicity. For patients who are auto-HSCT-eligible, hematopoietic stem cell mobilization should occur within 4 cycles of a Lenalidomide-containing therapy.
Lenalidomide Maintenance Therapy Following Auto-HSCT: Following auto-HSCT, initiate Lenalidomide maintenance therapy after adequate hematologic recovery (ANC at least 1000/mcL and/or platelet counts at least 75,000/mcL). The recommended starting dose of Lenalidomide is 10 mg once daily continuously (Days 1-28 of repeated 28-day cycles) until disease progression or unacceptable toxicity. After 3 cycles of maintenance therapy, the dose can be increased to 15 mg once daily if tolerated.
Recommended Dosage for Myelodysplastic Syndromes: The recommended starting dose of Lenalidomide is 10 mg daily. Treatment is continued or modified based upon clinical and laboratory findings. Continue treatment until disease progression or unacceptable toxicity.
Recommended Dosage for Mantle Cell Lymphoma: The recommended starting dose of Lenalidomide is 25 mg/day orally on Days 1-21 of repeated 28-day cycles for relapsed or refractory mantle cell lymphoma. Treatment should be continued until disease progression or unacceptable toxicity. Treatment is continued, modified or discontinued based upon clinical and laboratory findings.
Recommended Dosage for Follicular Lymphoma or Marginal Zone Lymphoma: The recommended starting dose of Lenalidomide is 20 mg orally once daily on Days 1-21 of repeated 28-day cycles for up to 12 cycles of treatment in combination with a Rituximab-product.
","Patients should be advised to take Lenalidomide orally at about the same time each day, either with or without food. Patients should be advised to swallow Lenalidomide capsules whole with water and not to open, break, or chew them.
","Digoxin: When Digoxin was co-administered with multiple doses of Lenalidomide (10 mg/day) the Digoxin Cmax and AUCinf were increased by 14%. Periodic monitoring of Digoxin plasma levels, in accordance with clinical judgment and based on standard clinical practice in patients receiving this medication, is recommended during administration of Lenalidomide.
Concomitant Therapies That May Increase the Risk of Thrombosis: Erythropoietic agents, or other agents that may increase the risk of thrombosis, such as estrogen-containing therapies, should be used with caution after making a benefit-risk assessment in patients receiving Lenalidomide.
Warfarin: Co-administration of multiple doses of Lenalidomide (10 mg/day) with a single dose of Warfarin (25 mg) had no effect on the pharmacokinetics of Lenalidomide or R- and S-Warfarin. It is not known whether there is an interaction between Dexamethasone and Warfarin. Close monitoring of PT and INR is recommended in patients with MM taking concomitant Warfarin.
","Pregnancy: Lenalidomide can cause fetal harm when administered to a pregnant female. Limb abnormalities were seen in the offspring of monkeys that were dosed with lenalidomide during organogenesis. This effect was seen at all doses tested. Due to the results of this developmental monkey study, and lenalidomide’s structural similarities to thalidomide, a known human teratogen, lenalidomide is contraindicated in females who are pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus
Severe Hypersensitivity Reactions: Lenalidomide is contraindicated in patients who have demonstrated severe hypersensitivity
","Embryo-fetal toxicity, hematologic toxicity, venous and arterial thromboembolism, increased mortality in patients with CLL, second primary malignancies, hepatotoxicity, severe cutaneous reaction tumor lysis syndrome, tumor flare reactions, impaired stem cell mobilization, thyroid disorders. early mortality in patients with MCL, hypersensitivity. Severe Hypersensitivity Reactions: Lenalidomide is contraindicated in patients who have demonstrated hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to Lenalidomide.
","Based on the mechanism of action, Lenalidomide can cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy. There is no information regarding the presence of Lenalidomide in human milk, the effects of Lenalidomide on the breastfed infant, or the effects of Lenalidomide on milk production. Because many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed infants from Lenalidomide, advise women not to breastfeed during treatment with Lenalidomide.
","Lenalidomide REMS Program: Because of the embryo-fetal risk, Lenalidomide is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), the Lenalidomide REMS
program. Required components of the Lenalidomide REMS program include the following:
+
+- Prescribers must be certified with the Lenalidomide REMS program by enrolling and complying with the REMS requirements.
+- Patients must sign a Patient-Physician agreement form and comply with the REMS requirements. In particular, female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements.
+- Pharmacies must be certified with the Lenalidomide REMS program, must only dispense to patients who are authorized to receive Lenalidomide and comply with REMS requirements.
+
+
Hematologic Toxicity: Lenalidomide can cause significant neutropenia and thrombocytopenia. Monitor patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising, especially with use of concomitant medication that may increase risk of bleeding. Patients taking Lenalidomide should have their complete blood counts assessed periodically as described below. Monitor complete blood counts (CBC) in patients taking Lenalidomide in combination with Dexamethasone or as Lenalidomide maintenance therapy for MM every 7 days (weekly) for the first 2 cycles, on Days 1 and 15 of Cycle 3, and every 28 days (4 weeks) thereafter. A dose interruption and/or dose reduction may be required. Monitor complete blood counts (CBC) in patients taking Lenalidomide for MDS weekly for the first 8 weeks and at least monthly thereafter. Monitor complete blood counts (CBC) in patients taking Lenalidomide for MCL weekly for the first cycle (28 days), every 2 weeks during cycles 2-4, and then monthly thereafter. Patients may require dose interruption and/or dose reduction. Monitor complete blood counts (CBC) in patients taking Lenalidomide for FL or MZL weekly for the first 3 weeks of Cycle 1 (28 days), every 2 weeks during Cycles 24, and then monthly thereafter. Patients may require dose interruption and/or dose reduction.
Venous and Arterial Thromboembolism: Venous thromboembolic events (VTE [DVT and PE]) and arterial thromboembolic events (ATE, myocardial infarction and stroke) are increased in patients treated with Lenalidomide. Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize all modifiable factors (e.g. hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended. The regimen of thromboprophylaxis should be based on an assessment of the patient’s underlying risks. Instruct patients to report immediately any signs and symptoms suggestive of thrombotic events. ESAs and estrogens may further increase the risk of thrombosis and their use should be based on a benefit-risk decision in patients receiving Lenalidomide.
Increased Mortality in Patients with CLL: Lenalidomide is not indicated and not recommended for use in CLL outside of controlled clinical trials.
Second Primary Malignancies: Monitor patients for the development of second primary malignancies. Take into account both the potential benefit of Lenalidomide and the risk of second primary malignancies when considering treatment with Lenalidomide.
Increased Mortality in Patients with MM When Pembrolizumab Is Added to a Thalidomide Analogue and Dexamethasone: Treatment of patients with MM with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus Dexamethasone is not recommended outside of controlled clinical trials.
Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with Lenalidomide in combination with Dexamethasone. The mechanism of drug-induced hepatotoxicity is unknown. Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors. Monitor liver enzymes periodically. Stop Lenalidomide upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered.
Severe Cutaneous Reactions Including Hypersensitivity Reactions: Angioedema and severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. DRESS may present with a cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive Lenalidomide. Lenalidomide interruption or discontinuation should be considered for Grade 2-3 skin rash. Lenalidomide must be discontinued for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS, TEN or DRESS is suspected and should not be resumed following discontinuation for these reactions.
Tumor Lysis Syndrome: Monitor patients at risk closely and take appropriate preventive approaches. Tumor Flare Reaction: Monitoring and evaluation for TFR is recommended in patients with MCL, FL, or MZL. Tumor flare reaction may mimic the progression of disease (PD).
Impaired Stem Cell Mobilization: A decrease in the number of CD34+ cells collected after treatment (>4 cycles) with Lenalidomide has been reported. In patients who are auto-HSCT candidates, referral to a transplant center should occur early in treatment to optimize the timing of the stem cell collection. In patients who received more than 4 cycles of a Lenalidomide-containing treatment or for whom inadequate numbers of CD 34+ cells have been collected with G-CSF alone, G-CSF with cyclophosphamide or the combination of GCSF with a CXCR4 inhibitor may be considered.
Thyroid Disorders: Both hypothyroidism and hyperthyroidism have been reported. Measure thyroid function before the start of Lenalidomide treatment and during therapy.
","Pediatric Use: The safety and effectiveness in pediatric patients have not been established.
","There is no specific experience in the management of Lenalidomide overdose in patients with MM, MDS, or MCL.
",,,"Store below 30°C in a dry place. Protect from light. Keep out of the reach of children.
",12
+668,Leflunomide,leflunomide-668,https://medex.com.bd/attachments/Vf7b7ID5ncUiufiTNtSppkwaA8MlmM/leflunomide-prescribing-information,Drugs used for Rheumatoid Arthritis,Rheumatoid arthritis,"Leflunomide is indicated in adults for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms and to retard structural damage as manifested by x-ray erosions and joint space narrowing.
","Drugs used for Rheumatoid Arthritis
","Leflunomide is an isoxazole immunomodulatory agent which inhibits de novo pyrimidine synthesis and has anti-proliferative activity. Following oral administration, it is rapidly metabolized to A771726, which is active in vitro and is presumed to be the active drug in vivo. Leflunomide has demonstrated prophylactic and therapeutic effects in animal models of autoimmune disease. In addition, leflunomide has exhibited anti-inflammatory and weak analgesic and antipyretic activity. In a model of experimental septicemia, leflunomide did not alter the resistance of mice to bacterial pathogens.
","Leflunomide once-daily oral dosing for rheumatoid arthritis patients. After a loading dose of 100 mg once daily for 3 days, the maintenance dose is 20 mg once daily. Leflunomide does not require step wise dose increment over time. The dose may be decreased to 10 mg daily if tolerability issues arise.
",,"Cholestyramine and activated charcoal may decrease plasma concentration of active metabolite. Concurrent use of methotrexate and other hepatotoxic drugs may increase the risk of hepatotoxicity. Rifampicin increases serum levels of the active metabolite.
","Leflunomide is contraindicated in patients with known hypersensitivity to leflunomide or any of the other components of leflunomide, hepatic impairment, severe uncontrolled infections and bone marrow dysplasia.
","Adverse reactions associated with the use of leflunomide include diarrhea, nausea, vomiting, abdominal pain, headache, respiratory infection, bronchitis, elevated liver enzymes, aggravation of pre-existing hypertension, alopecia, and rash.
","Leflunomide is not recommended for pregnant women. Pregnancy must be avoided during leflunomide treatment or prior to the completion of the drug elimination procedure after leflunomide treatment. Leflunomide should not be used by nursing mothers. It is not known whether leflunomide is excreted in human milk. Many drugs are excreted in human milk and there is a potential for serious adverse reactions in nursing infants from leflunomide. Therefore, a decision should be made whether to proceed with nursing or initiate treatment with leflunomide, taking into account the importance of the drug to the mother.
","Caution should be taken for those female with child bearing potential who are not using reliable contraception and for the subject of renal insufficiency. Leflunomide should be stopped before becoming pregnant. Liver function should be monitored before starting treatment.
",,"There is no human experience regarding leflunomide over dosage. In the event of a significant overdose or toxicity, cholestyramine or charcoal administration is recommended to accelerate elimination.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+667,Ledipasvir + Sofosbuvir,ledipasvir-sofosbuvir-667,https://medex.com.bd/attachments/drn88pm97KwfkEV6k2ZkFU5nDoTT3j/ledipasvir-sofosbuvir-prescribing-information,Hepatic viral infections (Hepatitis C),Chronic hepatitis C,"Ledipasvir and Sofosbuvir combination is indicated for the treatment of chronic hepatitis C (CHC) genotype 1, 4 & 6 infection in adults.
","Hepatic viral infections (Hepatitis C)
","It is a fixed-dose combination tablet containing Ledipasvir and Sofosbuvir for oral administration. Ledipasvir is an HCV NS5A inhibitor and Sofosbuvir is a nucleotide analog inhibitor of HCV NS5B polymerase.
","Recommended dosage: One tablet (90 mg of Ledipasvir and 400 mg of Sofosbuvir) taken orally once daily with or without food
Recommended treatment duration:
+
+- Treatment-naive with or without cirrhosis: 12 weeks
+- Treatment-experienced without cirrhosis: 12 weeks
+- Treatment-experienced with cirrhosis: 24 weeks
+
+A dose recommendation cannot be made for patients with severe renal impairment or end stage renal disease.
",,"
+- Coadministration with amiodarone may result in serious symptomatic bradycardia. Use of Ledipasvir and Sofosbuvir combination with Amiodarone is not recommended
+- P-gp inducers (e.g., Rifampin, St. John’s wort): May alter concentrations of Ledipasvir and Sofosbuvir. Use of Ledipasvir and Sofosbuvir combination with P-gp inducers is not recommended
+
","This combination is contraindicated in patients with Known hypersensitivity to Ledipasvir, Sofosbuvir or any other ingredient in the product.
","The most common adverse reactions with treatment with Ledipasvir and Sofosbuvir combination for 8, 12, or 24 weeks are fatigue and headache.
","Pregnancy Category B. There are no adequate and well-controlled studies with Ledipasvir and Sofosbuvir in pregnant women. Because animal reproduction studies are not always predictive of human response, this should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is not known whether Ledipasvir and Sofosbuvir and its metabolites are present in human breast milk.
","Bradycardia with Amiodarone coadministration: Serious symptomatic bradycardia may occur in patients taking Amiodarone, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Coadministration of Amiodarone with Ledipasvir and Sofosbuvir combination is not recommended. In patients without viable treatment options, cardiac monitoring is recommended.
Use with other drugs containing sofosbuvir, is not recommended
","Pediatric Use: Safety and effectiveness of Ledipasvir and Sofosbuvir have not been established in pediatric patients.
Geriatric Use: No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. No dosage adjustment of Ledipasvir and Sofosbuvir is warranted in geriatric patients.
","No specific antidote is available for overdose
",,,"Keep out of the reach of children. Keep in a cool & dry place. Protect from light.
",12
+665,Latanoprost + Timolol,latanoprost-timolol-665,https://medex.com.bd/attachments/f49LwypL6UP6pqaWrfuoVuMj0WNbH6/latanoprost-timolol-prescribing-information,Drugs for miotics and glaucoma,Open angle glaucoma,"This preparation is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufftciently responsive to β-blockers, prostaglandins or other IOP lowering agents.
","Drugs for miotics and glaucoma
","Latanoprost is an analogue of prostaglandin F2α, it reduces intraocular pressure (IOP) by increasing outflow of aqueous humour.
Timolol is a non-selective adrenergic blocker. It lowers IOP by decreasing the formation of aqueous by the ciliary epithelium.
","Adult or elderly: The recommended adult (including the elderly) dosage of is one drop in the affected eye(s) once daily. If one dose is missed, treatment should continue with the next dose as normal.
Children: Safety and effectiveness in children has not been established. This is therefore is not recommended for use in children.
",,"No specific interaction studies have been performed with this preparation. Patients who are receiving treatment with this preparation and an oral β-adrenergic blocking agent should be observed for potential additive effects of β-blockade, both systemic and on lntraocular pressure The concomitant use of two topical β-adrenergic blocking agents is not recommended. Although this preparation alone has little or no effect on pupil size, mydriasis has occasionally been reported when Timolol is given with epinephrine. β-blockers may increase the hypoglycemic effect of antidiabetic agents. In vitro studies have shown that precipitation occurs when eye drops containing thimerosal are mixed with Benzalkonium chloride, the preservative used in this preparatlon. If such drugs are used they should be administered with an interval of at least 5 minutes between applications. Similarly, several contact lens soakinq solutions contain thimerosal.
","This combination is contraindicated in patients with Known hypersensitivity to Latanoprost, Timolol and benzalkonium chloride or any other ingredient in the product. This combination is also contraindicated for the following conditions such as reactive airway disease including bronchial asthma, history of bronchial asthma or severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, or cardiogenic shock.
","This combination is generally well tolerated. The most frequent findings of increased iris pigmentation were in patients with green-brown, yellow-brown and blue/grey/brown irides. In patients with homogeneously blue, grey, green or brown eyes, the change was only rarely seen. Darkening, thickening and lengthening of the eye lashes have been reported. The most frequently reported undesirable effects in clinical trials were irritation of the eye, including stinging, burning and ,itching, eye hyperaemia, corneal disorders, coniunctivitis blepharitis, eye pain, headache and skin rash.
","No reproduction toxicity studies have been conducted with this combination.This combination should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Latanoprost and its metabolites may pass into breast milk. Timolol maleate has been detected in human milk following ocular administration. Because of the potential serious adverse reactions in nursing infants, this preparation should be used with caution in nursing women.
","This preparation should be used with caution in patients with macular edema, aphakic patients, pseudophakic parients with a torn posterior lens capsule or in patients with known risk factors for macular edema.It should be administered with caution in patients subjected to spontaneous hypoglycaemia or to diabetic patients who are receiving insulin or oral hypoglycaemic agents.Caution should also be exercised to patients wearing contact lenses or drive and use machines.
",,"There is no human data available on over dosage with this preparation.Symptoms of systemic Timolol over dosage are bradycardia, hypotenslon, bronchospasm, and cardiac arrest. If such symptoms occur,treatment should be symptomatic and supportive. The ocular effects of Latanoprost administered at high doses are not known. If overdose with this preparation occurs, treatment should be symptomatic.
",,,"Store at 2-8° C. For opened bottles, may store below 25° C.
",11
+666,Latanoprost,latanoprost-666,https://medex.com.bd/attachments/6NTk9j62Oj7507MRZo8oc6cWs22xjh/latanoprost-prescribing-information,Drugs for miotics and glaucoma,Open angle glaucoma,"Latanoprost Sterile Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
","Drugs for miotics and glaucoma
","Latanoprost is an analogue of prostaglandin F2α. Latanoprost is a prostanoid selective FP receptor agonist that is believed to reduce the intraocular pressure (IOP) by increasing the outflow of aqueous humor. Studies in animals and man suggest that the main mechanism of action is increased uveoscleral outflow. Elevated IOP represents a major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss.
","The recommended dosage is 1 drop (1.5 mcg) in the affected eye(s) once daily in the evening. This is for topical ophthalmic use only. Not for injection or oral use.
",,"In vitro studies have shown that precipitation occurs when eye drops containing thimerosal are mixed with latanoprost. If such drugs are used they should be administered with an interval of at least 5 minutes between applications.
","Known hypersensitivity to latanoprost, benzalkonium chloride or any other ingredients in this product.
","Eyelash changes (increased length, thickness, pigmentation, and number of lashes); eyelid skin darkening; intraocular inflammation (iritis/uveitis); iris pigmentation changes; and macular edema, including cystoid macular edema. The ocular adverse events and ocular signs and symptoms reported in 5- 15% of the patients on latanoprost in the 6 month, multicenter, double-masked, active-controlled trials were blurred vision, burning and stinging, conjunctival hyperemia, foreign body sensation, itching, increased pigmentation of the iris, and punctate epithelial keratopathy. Local conjunctiva hyperemia was observed; however, less than 1% of the latanoprost treated patients required discontinuation of therapy because of intolerance to conjunctival hyperemia.
","Pregnancy Category C. There are no adequate and well controlled studies in pregnant women. The drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
","Ophthalmic Solution may gradually increase the pigmentation of the iris. The eye color change is due to increased melanin content in the stromal melanocytes of the iris rather than to an increase in the number of melanocytes. During clinical trials, the increase in brown iris pigment has not been shown to progress further upon discontinuation of treatment, but the resultant color change may be permanent. Eyelid skin darkening, which may be reversible. There may be increased length, thickness, pigmentation, the number of lashes or hairs, and misdirected growth of eyelashes. Eyelash changes are usually reversible upon discontinuation of treatment. It should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation. This drug should be used with caution in patients who do not have an intact posterior capsule or who have known risk factors for macular edema.
","Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
",,,,"Before opening the cap, keep the bottle in its box in a refrigerator (2°-8° C) protected from light. After opening, keep the bottle in its box in a cool place below 25° C. The contents should be used within one month after the dropper is opened. Keep out of reach of children
",11
+2072,Lasmiditan Hemisuccinate,lasmiditan-hemisuccinate-2072,https://medex.com.bd/attachments/QZYISsFOCRjQ4OxbZNCGYylCuFRl4p/lasmiditan-hemisuccinate-prescribing-information,Other drugs for migraine,Migraine,"Lasmiditan is indicated for the acute treatment of migraine with or without aura in adults. Lasmiditan is not indicated for the preventive treatment of migraine.
","Other drugs for migraine
","The acute treatment of migraine headaches has, in the past, been achieved via constriction of cerebral blood vessels, as the acute dilation of these vessels observed during migraines was thought to be the cause of the associated pain. The neurogenic hypothesis of migraine pathophysiology, an alternative to the vascular hypothesis, suggests that cerebral vasodilation is a secondary mechanism in migraine pathogenesis, and that the main contributor to migraine headache pain is the increased pathogenic firing of trigeminal nerve pathways.
While the precise mechanism of action of lasmiditan is unclear, it likely supports this neurogenic hypothesis by exerting its therapeutic effects through potent and selective agonism of the 5-HT1F receptor. 5-HT1F receptors are found in both the central and peripheral nervous system (on the central and peripheral ends of trigeminal neurons) and appear to contribute to hyperpolarization of nerve terminals and inhibition of trigeminal neuronal activity. Lasmiditan's agonism at these receptors may, therefore, inhibit the firing of trigeminal nerves responsible for migraine headache pain.
Lasmiditan has virtually no affinity for other 5-HT receptor subtypes or monoamine receptors (e.g. adrenergic, dopaminergic).
","The recommended dose of Lasmiditan is 50 mg, 100 mg, or 200 mg taken orally, as needed. No more than one dose should be taken in 24 hours, and Lasmiditan should not be taken unless the patient can wait at least 8 hours between dosing and driving or operating machinery. A second dose of Lasmiditan has not been shown to be effective for the same migraine attack. The safety of treating an average of more than 4 migraine attacks in a 30-day period has not been established. Lasmiditan may be taken with or without food.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Hepatic Impairment: No dosage adjustment is needed for patients with mild or moderate hepatic impairment (Child-Pugh A or B). In patients with severe hepatic impairment (Child-Pugh C) and its use in these patients is not recommended.
",,"CNS Depressants: Concomitant administration of Lasmiditan and alcohol or other CNS depressant drugs has not been evaluated in clinical studies. Because of the potential of Lasmiditan to cause sedation, as well as other cognitive and/or neuropsychiatric adverse reactions, Lasmiditan should be used with caution if used in combination with alcohol or other CNS depressants
Serotonergic Drugs: Concomitant administration of Lasmiditan and drugs (e.g., SSRIs, SNRIs, TCAs, MAO inhibitors, trazodone, etc.), over-the-counter medications (e.g., dextromethorphan), or herbal supplements (e.g., St. John’s Wort) that increase serotonin may increase the risk of serotonin syndrome. Use Lasmiditan with caution in patients taking medications that increase serotonin.
Heart Rate Lowering Drugs: Lasmiditan has been associated with a lowering of heart rate. In a drug interaction study, addition of a single 200 mg dose of Lasmiditan to propranolol decreased heart rate by an additional 5 beats per minute compared to propranolol alone, for a mean maximum of 19 beats per minute. Use Lasmiditan with caution in patients taking concomitant medications that lower heart rate if this magnitude of heart rate decrease may pose a concern.
P-gp and Breast Cancer Resistant Protein (BCRP): Lasmiditan inhibits P-gp and BCRP in vitro. Concomitant use of Lasmiditan and drugs that are P-gp or BCRP substrates should be avoided.
",,"The most common side effects of Lasmiditan include: dizziness, sleepiness, numbness, feeling tired, tingling.
","There are no adequate data on the developmental risk associated with the use of Lasmiditan in pregnant women. There are no data on the presence of lasmiditan in human milk, the effects of lasmiditan on the breastfed infant, or the effects of lasmiditan on milk production. Excretion of lasmiditan and/or metabolites into milk, at levels times those in maternal plasma, was observed in lactating rats following oral administration of lasmiditan. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Lasmiditan and any potential adverse effects on the breastfed infant from Lasmiditan or from the underlying maternal condition.
","Driving Impairment: Advise patients not to drive or operate machinery until at least 8 hours after taking each dose of Lasmiditan. Patients who cannot follow this advice should not take Lasmiditan. Patients may not be able to assess their own driving competence and the degree of impairment caused by Lasmiditan.
Central Nervous System (CNS) Depression: Lasmiditan may cause CNS depression and should be used with caution if used in combination with alcohol or other CNS depressants.
Serotonin Syndrome: Reactions consistent with serotonin syndrome were reported in patients treated with Lasmiditan. Discontinue Lasmiditan if symptoms of serotonin syndrome occur.
Medication Overuse Headache: Detoxification may be necessary.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+1894,Larotrectinib,larotrectinib-1894,https://medex.com.bd/attachments/dorg2PclEAieOujz06xwhqb3XXEKiV/larotrectinib-prescribing-information,,,"Larotrectinib is indicated for the treatment of adult and pediatric patients with solid tumors that:
+
+- have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,
+- are metastatic or where surgical resection is likely to result in severe morbidity, and
... Read more
Larotrectinib is indicated for the treatment of adult and pediatric patients with solid tumors that:
+
+- have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,
+- are metastatic or where surgical resection is likely to result in severe morbidity, and
+- have no satisfactory alternative treatments or that have progressed following treatment.
+
",,"Larotrectinib is an inhibitor of the tropomyosin receptor kinases (TRK), TRKA, TRKB, and TRKC. In a broad panel of purified enzyme assays, larotrectinib inhibited TRKA, TRKB, and TRKC with IC50 values between 5-11 nM. One other kinase TNK2 was inhibited at approximately 100-fold higher concentrations. TRKA, B, and C are encoded by the genes NTRK1, NTRK2, and NTRK3. Chromosomal rearrangements involving in-frame fusions of these genes with various partner scan result in constitutively activated chimeric TRK fusion proteins that can act as an oncogenic driver, promoting cell proliferation and survival in tumor cell lines.
Absorption: The mean absolute bioavailability of Larotrectinib capsules was 34% (range: 32% to 37%).
Distribution: The mean (CV%) volume of distribution (Vss) of Larotrectinib is 48 (38%) L following intravenous administration of Larotrectinib in healthy subjects. Larotrectinib is 70% bound to human plasma proteins in vitro and binding is independent of drug concentrations. The blood-to-plasma concentration ratio is 0.9.
Elimination: The mean (CV%) clearance (CL/F) of Larotrectinib is 98 (44%) L/h and the half-life is 2.9 hours following oral administration of Larotrectinib in healthy subjects.
Metabolism: Larotrectinib is metabolized predominantly by CYP3A4. Following oral administration of a single [14C] radiolabeled 100 mg dose of Larotrectinib to healthy subjects, unchanged Larotrectinib constituted 19% and an O-linked glucuronide constituted 26% of the major circulating radioactive drug components in plasma.
Excretion: Following oral administration of a single [ 14 C] radiolabeled 100 mg dose of Larotrectinib to healthy subjects, 58% (5% unchanged) of the administered radioactivity was recovered in feces and 39% (20% unchanged) was recovered in urine.
","Recommended Dosage in Adult and Pediatric Patients with Body Surface Area of at Least 1 m2: The recommended dosage of Larotrectinib is 100 mg orally twice daily, with or without food, until disease progression or until unacceptable toxicity.
Recommended Dosage in Pediatric Patients with Body Surface Area Less Than 1 m2: The recommended dosage of Larotrectinib is 100 mg/m2 orally twice daily, with or without food, until disease progression or until unacceptable toxicity. Whole capsules should be swallowed with water and the capsules should not be chewed or crushed. A missed dose should not be made up within 6 hours of the next scheduled dose. If vomiting occurs after taking a dose of Larotrectinib, the next dose should be taken at the scheduled time. Or, as directed by the registered physicians.
",,"Effects of Other Drugs on Larotrectinib: Strong CYP3A4 Inhibitors: Coadministration of Larotrectinib with a strong CYP3A4 inhibitor may increase Larotrectinib plasma concentrations, which may result in a higher incidence of adverse reactions. Coadministration of Larotrectinib should be avoided with strong CYP3A4 inhibitors, including grapefruit or grapefruit juice. If coadministration of strong CYP3A4 inhibitors cannot be avoided, Larotrectinib dose as recommended should be modified.
Strong CYP3A4 Inducers: Coadministration of Larotrectinib with a strong CYP3A4 inducer may decrease Larotrectinib plasma concentrations, which may decrease the efficacy of Larotrectinib. Coadministration of Larotrectinib should be avoided with strong CYP3A4 inducers, including St. John’s wort. If coadministration of strong CYP3A4 inducers cannot be avoided, Larotrectinib dose as recommended should be modified.
Effects of Larotrectinib on Other Drugs: Sensitive CYP3A4 Substrates: Coadministration of Larotrectinib with sensitive CYP3A4 substrates may increase their plasma concentrations, which may increase the incidence or severity of adverse reactions. Coadministration of Larotrectinib should be avoided with sensitive CYP3A4 substrates. If coadministration of these sensitive CYP3A4 substrates cannot be avoided, patients for increased adverse reactions of these drugs should be monitored.
","It is contraindicated in patients with known hypersensitivity to Larotrectinib or any other components of this product.
","Common side effects are Neurotoxicity, Hepatotoxicity.
","Larotrectinib can cause embryo-fetal harm when administered to a pregnant woman. There are no available data on Larotrectinib use in pregnant women. Pregnant women should be advised of the potential risk to a fetus. There are no data on the presence of Larotrectinib or its metabolites in human milk and no data on its effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children, women should be advised not to breastfeed during treatment with Larotrectinib and for 1 week after the final dose.
","Neurotoxicity: Among the 176 patients who received Larotrectinib, neurologic adverse reactions of any grade occurred in 53% of patients, including Grade 3 and Grade 4 neurologic adverse reactions in 6% and 0.6% of patients, respectively. The majority (65%) of neurologic adverse reactions occurred within the first three months of treatment (range: 1 day to 2.2 years). Grade 3 neurologic adverse reactions included delirium (2%), dysarthria (1%), dizziness (1%), gait disturbance (1%), and paresthesia (1%). Grade 4 encephalopathy (0.6%) occurred in a single patient. Neurologic adverse reactions leading to dose modification included dizziness (3%), gait disturbance (1%), delirium (1%), memory impairment (1%), and tremor (1%). Patients and caretakers should be advised of these risks with Larotrectinib. Patients should be advised not to drive or operate hazardous machinery if they are experiencing neurologic adverse reactions. Larotrectinib should be withheld or permanently discontinued based on the severity. If withheld, Larotrectinib dosage should be modified when resumed.
Hepatotoxicity: Among the 176 patients who received Larotrectinib, increased transaminases of any grade occurred in 45%, including Grade 3 increased AST or ALT in 6% of patients. One patient (0.6%) experienced Grade 4 increased ALT. The median time to onset of increased AST was 2 months (range: 1 month to 2.6 years). The median time to onset of increased ALT was 2 months (range: 1 month to 1.1 years). Increased AST and ALT leading to dose modifications occurred in 4% and 6% of patients, respectively. Increased AST or ALT led to permanent discontinuation in 2% of patients. Liver tests should be monitored, including ALT and AST, every 2 weeks during the first month of treatment, then monthly thereafter, and as clinically indicated. Larotrectinib should be withheld or permanently discontinued based on the severity. If withheld, Larotrectinib dosage should be modified when resumed.
Embryo-Fetal Toxicity: Based on literature reports in human subjects with congenital mutations leading to changes in TRK signaling, findings from animal studies, and its mechanism of action, Larotrectinib can cause fetal harm when administered to a pregnant woman. Women should be advised of the potential risk to a fetus. Females of reproductive potential should be advised to use an effective method of contraception during treatment and for 1 week after the final dose of Larotrectinib.
","Females: Female patients of reproductive potential should be advised to use effective contraception during treatment with Larotrectinib and for at least 1 week after the final dose.
Males: Males with female partners of reproductive potential should be advised to use effective contraception during treatment with Larotrectinib and for 1 week after the final dose.
Pediatric Use: The safety and effectiveness of Larotrectinib in pediatric patients was established based upon data from three multicenter, open-label, single-arm clinical trials in adult or pediatric patients 28 days and older.
Geriatric Use: Clinical studies of Larotrectinib did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
",,,,"Store below 30°C in a cool and dry place, away from sunlight. Keep out of reach of children.
",10
+664,Lapatinib,lapatinib-664,https://medex.com.bd/attachments/zlbz41wJi7CdQX2fl1wg2tomuPguoi/lapatinib-prescribing-information,Cytotoxic Chemotherapy,Carcinoma,"Lapatinib, a kinase inhibitor, is indicated in combination with:
+
+- Capecitabine, for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab.
+- Letrozole for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated.
... Read more
Lapatinib, a kinase inhibitor, is indicated in combination with:
+
+- Capecitabine, for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab.
+- Letrozole for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated.
+
+Lapatinib in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.
","Cytotoxic Chemotherapy
","Lapatinib is a 4-anilinoquinazoline tyrosine kinase inhibitor of both Epidermal Growth Factor Receptor (EGFR [ErbB1]) and Human Epidermal Receptor Type 2 (HER2 [ErbB2]) receptors. It blocks the phosphorylation and activation of downstream 2nd messengers (Erk1/2 and Akt) which regulate cellular proliferation and survival of ErbB- and ErbB2-expressing tumours.
","The recommended dosage of Lapatinib for advanced or metastatic breast cancer is 1,250 mg (5 tablets) given orally once daily on Days 1-21 continuously in combination with capecitabine 2,000 mg/m2/day (administered orally in 2 doses approximately 12 hours apart) on Days 1-14 in a repeating 21 day cycle.
The recommended dose of Lapatinib for hormone receptor positive, HER2 positive metastatic breast cancer is 1500 mg (6 tablets) given orally once daily continuously in combination with letrozole. When Lapatinib is coadministered with letrozole, the recommended dose of letrozole is 2.5 mg once daily.
+
+- Lapatinib should be taken at least one hour before or one hour after a meal. However, capecitabine should be taken with food or within 30 minutes after food.
+- Lapatinib should be taken once daily. Do not divide daily doses of Lapatinib.
+- Modify dose for cardiac and other toxicities, severe hepatic impairment, and CYP3A4 drug interactions.
+
","Should be taken on an empty stomach. Take at least 1 hr before or 1 hr after a meal. Do not eat/drink grapefruit products.
","May increase the serum levels of CYP3A4, CYP2C8 and P-glycoprotein substrates. Increased exposure with CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, atazanavir, ritonavir). CYP3A4 inducers (e.g. carbamazepine, rifampicin) may reduce exposure to lapatinib. Increased risk of QT prolongation with drugs known to prolong QT intervals (e.g. antiarrythmic agents, cumulative high-dose anthracycline therapy). May increase serum levels of digoxin.
","Contraindicated to hypersensitivity to any other ingredient of this product.
","GI disturbances, dermatological reactions (e.g. palmar-plantar erythrodysesthesia, rash), fatigue, decreases in LVEF, QT interval prolongation, stomatitis, mucosal inflammation, pain in extremities, back pain, dyspnoea, insomnia, epistaxis, alopecia, nail disorders (e.g. paronychia), interstitial lung disease, pneumonitis and hypersensitivity reactions including anaphylaxis.
","Pregnancy category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Patient with hypokalaemia or hypomagnesaemia, congenital QT prolongation. Severe hepatic impairment. Pregnancy and lactation.
","Patient on potent CYP3A4 inhibitor-
+
+- HER2 overexpressing advanced or metastatic breast cancer: Increase gradually from 1.25 g daily up to 4.5 g daily.
+- HER2 overexpressing hormone receptor positive metastatic breast cancer: Increase gradually from 1.5 g daily up to 5.5 g daily.
+
+
Hepatic Impairment (Severe)-
+
+- HER2 overexpressing advanced or metastatic breast cancer: 750 mg once daily.
+- HER2 overexpressing hormone receptor positive metastatic breast cancer: 1 g once daily.
+
",,,,"Store between 15-30° C.
",12
+687,Linagliptin,linagliptin-687,https://medex.com.bd/attachments/5TCLXkvFiCmoOz77toZMhvzGON3O3s/linagliptin-prescribing-information,Dipeptidyl Peptidase-4 (DPP-4) inhibitor,Type 2 DM,"Linagliptin is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults.
+
+- As monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance or contraindicated due to renal impairment.
... Read more
Linagliptin is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults.
+
+- As monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance or contraindicated due to renal impairment.
+- As combination therapy: in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
+
","Dipeptidyl Peptidase-4 (DPP-4) inhibitor
","Linagliptin is indicated to improve glycemic control in patients with type 2 diabetes mellitus. Linagliptin is an inhibitor of DPP-4 (dipeptidyl peptidase-4), an enzyme that degrades the incretin hormones GLP-1 (glucagon like peptide-1) and GIP (glucose dependent insulinotropic polypeptide). Thus, Linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin from pancreatic beta (β) cells in a glucose-dependent manner and decreasing the secretion of glucagon from pancreatic alpha (α) cells in the circulation.
","Linagliptin 5 mg once daily. If added to metformin, the dose of metformin should be maintained and linagliptin administered concomitantly. When used in combination with a sulfonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
Patients with renal impairment: No dose adjustment required. Linagliptin can be taken with or without a meal at any time of the day.
",,"Linagliptin is a weak competitive and a weak to moderate mechanism-based inhibitor of CYP isozyme CYP3A4, but does not inhibit other CYP isozymes. The risk for clinically meaningful interactions by other medicinal products on linagliptin is low and in clinical studies linagliptin had no clinically relevant effect on the pharmacokinetics of metformin, glyburide, simvastatin, warfarin, digoxin or oral contraceptives.
","Hypersensitivity to the active substance or to any of the excipients.
","There may be hypoglycaemia, nasopharyngitis, cough and pancreatitis in combination with metformin and sulfonylurea.
","Pregnancy category B. There are no adequate and well controlled studies in pregnant women. So, Linagliptin tablets should be used during pregnancy only if clearly needed. It is not known whether Linagliptin passes into breast milk or not.
","Hypersensitivity to the active substance or to any of the excipients.
",,,,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",10
+1778,Light Liquid Paraffin + White Soft Paraffin + Glycerine,light-liquid-paraffin-white-soft-paraffin-glycerine-1778,,Emollients & combined preparations,Psoriasis,"This cream is a highly concentrated moisturizing cream that is indicated to-
+
+- Prevent and relieve dry skin
+- Manage dry skin problems associated with eczema, dermatitis and psoriasis.
+
","Emollients & combined preparations
","Glycerine is an exceptionally good moisturizing, emollient and protective agent. Its ability to capture and retain water slows down the evaporation of water from the surface of the skin. It is also a humectant (wetting agent), which promotes hydration of the skin. Light Liquid Paraffin and White Soft Paraffin exert an emollient effect by forming an occlusive film that reduces trans-epidermal water loss, thus helping to maintain normal skin humidity levels.
","A combination of Light Liquid Paraffin, White Soft Paraffin & Glycerine Cream is to be used as 'on-demand' basis when required. Apply to the affected area and rub in well. It is especially effective after bathing, showering, and exposure to harsh climatic conditions and at night.
",,,"Hypersensitivity to any of the ingredients.
","No remarkable adverse effects have been reported.
","There are no restrictions on the use during pregnancy or lactation.
","No remarkable adverse effects have been reported.
","Use in pediatric patients: Suitable for infants and children.
Use in geriatric patients: Suitable for the elderly.
",,,,"Store below 30°C, protected from light.
",10
+1541,Lifitegrast,lifitegrast-1541,https://medex.com.bd/attachments/HJkATTBYxlOUBAZKauTctVBsL5ZReM/lifitegrast-prescribing-information,Other ophthalmic preparations,Dry eye,"Lifitegrast 5% ophthalmic solution is indicated for the treatment of the signs and symptoms of dry eye disease (DED).
","Other ophthalmic preparations
","Lifitegrast binds to the integrin LFA-1, a cell surface protein found on leukocytes and blocks the interaction of LFA-1 with its cognate ligand intercellular adhesion molecule-1 (ICAM-1). ICAM-1 may be overexpressed in corneal and conjunctival tissues in DED. LFA-1/ICAM-1 interaction can contribute to the formation of an immunological synapse resulting in T-cell activation and migration to target tissues. In vitro studies demonstrated that lifitegrast may inhibit Tcell adhesion to ICAM-1 in a human T-cell line and may inhibit secretion of inflammatory cytokines in human peripheral blood mononuclear cells. The exact mechanism of action of lifitegrast in DED is not known.
","Instill one drop of Lifitegrast twice daily (approximately 12 hours apart) into each eye. Contact lenses should be removed prior to the administration of Lifitegrast and may be reinserted 15 minutes following administration.
",,,"Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.
","The common adverse effects are instillation site irritation, dysgeusia and reduced visual acuity. Less common are blurred vision, conjunctival hyperemia, headache, increased lacrimation, eye discharge, eye discomfort, eye pruritus and sinusitis.
","There are no available data on Lifitegrast use in pregnant women to inform any drug associated risks. There are no data on the presence of Lifitegrast in human milk, the effects on the breastfed infant or the effects on milk production.
","Do not touch the dropper tip to surfaces since this may contaminate the solution. After one month of the opening do not use the medicine of dropper.
","Pediatric Use: Safety and efficacy in pediatric patients below the age of 17 years have not been established.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.
","There is no information regarding overdose in patients taking Lifitegrast. For management of a suspected drug overdose, contact your ophthalmologist.
",,,"Store in a cool (below 30°C) and dry place, away from light. Keep out of the reach of children.
",11
+685,Lidocaine Hydrochloride (Spray),lidocaine-hydrochloride-spray-685,https://medex.com.bd/attachments/6Kmh0rJaS4ylYkH0EFLGIgeN9POUYH/lidocaine-hydrochloride-spray-spray-prescribing-information,Local & Surface anesthesia,Ventricular arrhythmias,"Lidocaine is a topical anesthetic used for the following purposes-
+
+- To help prevent pain associated with minor surgical procedures in the ear, nose and throat
+- To help prevent pain and or discomfort during dental procedures (e.g., prior to an injection)
+- During general anesthesia to prevent coughing
... Read more
Lidocaine is a topical anesthetic used for the following purposes-
+
+- To help prevent pain associated with minor surgical procedures in the ear, nose and throat
+- To help prevent pain and or discomfort during dental procedures (e.g., prior to an injection)
+- During general anesthesia to prevent coughing
+- To help prevent pain during the final stages of childbirth, before the cutting or stitching of the perineum (skin between the vagina and anus)
+
","Local & Surface anesthesia
","Lidocaine acts mainly by inhibiting sodium influx through sodium specific ion channels in the neuronal cell membrane, in particular the so called voltage-gated sodium channels. When the influx of sodium is interrupted, an action potential cannot arise and signal conduction is inhibited. The receptor site is thought to be located at the cytoplasmic (inner) portion of the sodium channel. Lidocaine binds more readily to sodium channels in activated state, thus onset of neuronal blockade is faster in neurons that are rapidly firing. This is referred to as state dependent blockade.
","
+- Each spray delivers 10 mg of Lidocaine. The maximum dose is 20 sprays (200 mg).
+- In dentistry, the normal dose is 1-5 sprays. Two sprays per quarter of the mouth is recommended, with a maximum of 3 sprays per quarter of the mouth over 30 minutes.
+- In sinus procedures 3 sprays are used.
+- In procedures of the throat and windpipe, up to 20 sprays may be necessary.
+- Up to 20 sprays may be necessary in child birth (cesarian procedure).
+- Lower doses are used for children aged 3-12 years. Lidocaine 10% Spray is not recommended for children under 3 years.
+
",,,"Should not be given to patients with myasthenia gravis, epilepsy, impaired cardiac condition or liver damage.
","Skin rash or irritation, drowsiness, wheezing or difficulty breathing, chest pain, severe rash or itching, increased sweating, numbness.
","No study available. Can be given to a pregnant woman as per doctor's judgment. Small amount of Lidocaine may pass to a lactating baby, but the amount is insignificant to cause any harm
","Patient should be careful driving or operating machinery after use of Lidocaine 10% Spray. Patient may be drowsy and reflexes may be slow. Patient should not eat or drink anything for at least 1 hour after using Lidocaine 10% Spray in the mouth or throat area. Should be careful not to spray Lidocaine 10% Spray near the eyes. If any of the spray does go in the eye, should rinse immediately with lots of water for at least 15 minutes and doctor should be called.
",,"The first signs that too much Lidocaine 10% Spray has been used usually take the form of light-headedness, drowsiness, dizziness and sometimes blurred vision. In the event of serious over dosage trembling, seizures or unconsciousness may occur.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+1629,Lidocaine Hydrochloride (Jelly),lidocaine-hydrochloride-jelly-1629,https://medex.com.bd/attachments/fkRLBA0s7ou8h8tMEBgUfzlVFFj0Ok/lidocaine-hydrochloride-jelly-prescribing-information,Local & Surface anesthesia,Pain,"Lidocaine Jelly is indicated for-
+
+- Surface anaesthesia of the male and female urethra
+- Topical treatment of painful urethritis
+- Anaesthetic lubrication for endotracheal intubation
+- Adequate analgesia in endoscopy.
+
","Local & Surface anesthesia
","Lidocaine acts mainly by inhibiting sodium influx through sodium specific ion channels in the neuronal cell membrane, in particular the so called voltage-gated sodium channels. When the influx of sodium is interrupted, an action potential cannot arise and signal conduction is inhibited. The receptor site is thought to be located at the cytoplasmic (inner) portion of the sodium channel. Lidocaine binds more readily to sodium channels in activated state, thus onset of neuronal blockade is faster in neurons that are rapidly firing. This is referred to as state dependent blockade.
","Urethral anaesthesia:
+
+- Surface anaesthesia of the male adult urethra: For adequate analgesia in males 400 mg is required.
+- Surface anaesthesia of the female adult urethra: Instil 100-200 mg in small portions to fill the whole urethra. In order to obtain adequate anaesthesia, several minutes should be allowed prior to perform in the urological procedure.
+
+
Lubrication for endotracheal intubation: 100 mg applied on the surface of the tube just prior to insertion. Care should be taken to avoid introducing the product into the lumen of the tube.
Endoscopy: Instillation of 200-400 mg is recommended for adequate analgesia and a small amount should be applied on the instrument for lubrication. Debilitated, elderly patients and children should be given doses commensurate with their age and physical condition.
Note: The applicator is sterilized for 5 minutes in boiling water, cooled and attached to the tube. The jelly is instilled slowly as required. The applicator should be detached after each use and keep the tube tightly closed.
",,"Lidocaine should be used with caution in patients receiving antiarrhythmic drugs, such as tocainide since the toxic effects are additive.
","It is contraindicated in patients with a known history of hypersensitivity of local anaesthetics of the amide type.
","Nervousness, dizziness, blurred vision, tremors, drowsiness, convulsions, unconsciousness, respiratory arrest, hypotension, myocardial depression, bradycardia, cardiac arrest and anaphylactic reactions (cutaneous lesion, urticaria, oedema).
","There is no, or inadequate, evidence of safety of the drug in human pregnancy but it has been in wide use for many years without apparent ill consequence. If drug therapy is needed in pregnancy, this drug can be used if there is no safer alternative. Lidocaine enters the mother's milk, but in such small quantities that there is generally no risk of affecting the child at therapeutic dose levels.
","Absorption from wound surfaces and mucous membranes is relatively high, especially in the bronchial tree. Lidocaine Jelly should be used with caution in patients with traumatised mucosa and/or sepsis in the region of the proposed application.
If the dose or site of administration is likely to result in high blood levels, Lidocaine, in common with other local anaesthetics, should be used cautiously in patients with epilepsy, impaired cardiac condition, bradycardia, impaired hepatic function and in severe shock.
The use of oropharyngeal topical anaesthetic agents may interfere with swallowing and thus enhance the danger of aspiration. This is particularly important in children because of their frequency of eating. Numbness of the tongue or buccal mucosa may increase the danger of biting trauma.
",,,,,"Store below 25°C in a dry place, away from light.
",10
+1630,Lidocaine Hydrochloride (Injection),lidocaine-hydrochloride-injection-1630,https://medex.com.bd/attachments/1UIojakYKzOyAxrzDA9Q0xFBmUUcY4/lidocaine-hydrochloride-injection-prescribing-information,Local & Surface anesthesia,Local pain relief,"Lidocaine Injection is indicated-
+
+- As a local anaesthetic for use in infiltration blockade and intravenous regional analgesia.
+- For the prevention and treatment of ventricular tachyarrhythmias
+
","Local & Surface anesthesia
","Lidocaine acts mainly by inhibiting sodium influx through sodium specific ion channels in the neuronal cell membrane, in particular the so called voltage-gated sodium channels. When the influx of sodium is interrupted, an action potential cannot arise and signal conduction is inhibited. The receptor site is thought to be located at the cytoplasmic (inner) portion of the sodium channel. Lidocaine binds more readily to sodium channels in activated state, thus onset of neuronal blockade is faster in neurons that are rapidly firing. This is referred to as state dependent blockade.
","The dosage is adjusted according to the response of the patient and site of administration.
Adult: For healthy adults, the maximum individual dose should not exceed 4.5mg/kg of body weight and in general it is recommended that the maximum total dose does not exceed 300 mg. Recommended doses given in the below serve only as a guide to the amount of anaesthetic required for most routine procedures.
Infiltration-
+
+- Percutaneous: Total dose 5-300 mg
+- Intravenous regional: Total dose 50-300 mg
+
+Peripheral Nerve Blocks-
+
+- Brachial: Total dose 225-300 mg
+- Dental: Total dose 20-100 mg
+- Intercostal: Total dose 30 mg
+- Paravertebral: Total dose 30-50 mg
+
+Pudenal (each side):
+
+- Paracervical Obstetrical analgesia: Total dose 100 mg
+
+Sympathetic Nerve Blocks
+
+- Cervical: Total dose 50 mg
+- Lumbar: Total dose 50-100 mg
+
+Central Neural Blocks
+
+- Epidural: Total dose 200-300 mg [Dose determined by number of dermatomes to be anesthetized (2-3 mL/dermatome) periodically.]
+- Thoracic: Total dose 200-300 mg
+
+Lumbar
+
+- Analgesia: Total dose 250-300 mg
+- Anesthesia: Total dose 200-300 mg
+
+Caudal
+
+- Obstetrical analgesia: Total dose 200-300 mg
+- Surgical anesthesia: Total dose 225-300 mg.
+
","Antiarrhythmic treatment: An intravenous dose of 1 mg.kg-1 may be given over 2 min and repeated after 5 min, but giving an infusion of 2-4 mg.min-1 to produce a plasma level of 2-4 mg. l-1 is a more satisfactory technique. To avoid a long delay in achieving a steady state, a loading dose of approximately 1 mg.kg-1 is usually given intravenously over 2 min at the outset.
","Cimetidine can impair the metabolism of lidocaine absorbed into the circulation. Elimination will be delayed and the risk of adverse reactions increased. Significant increases in plasma lidocaine concentrations have occurred during concomitant therapy with beta blockers such as propranolol, metoprolol or nadolol. It prolongs the duration of action of suxamethonium.
","Known hypersensitivity to anaesthetics of the amide type.
","In common with other local anaesthetics, adverse reactions to lidocaine are rare and are usually the result of excessively high blood concentrations due to inadvertent intravascular injection, excessive dosage, rapid absorption or occasionally to hypersensitivity, idiosyncracy or diminished tolerance on the part of the patient. In such circumstances systemic effects occur involving the central nervous system and/or the cardiovascular system. CNS reactions are excitatory and/or depressant and may be characterized by nervousness, dizziness, blurred vision and tremors, followed by drowsiness, convulsions, unconsciousness and possibly respiratory arrest. Cardiovascular reactions are hypotension, myocardial depression, bradycardia and possibly cardiac arrest. Allergic reactions are extremely rare. They may be characterized by cutaneous lesions, urticaria, oedema or anaphylactoid reactions.
","Although there is no evidence from animal studies of harm to the foetus, as with all drugs, it should not be given during early pregnancy unless the benefits are considered to outweigh the risks. Caution should be exercised when it is administered to a nursing woman.
","Lidocaine for infiltration and nerve block should be employed only by clinicians who are well versed in diagnosis and management of dose-related toxicity. The safety and effectiveness of lidocaine depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies. Standard text books should be consulted for specific techniques and precautions for various regional anaesthetic procedures. Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use.
It should be used cautiously in patients with epilepsy, impaired cardiac conduction, bradycardia, impaired respiratory function and in patients with impaired hepatic function, if the dose or site of administration is likely to result in high blood levels. The effect of local anaesthetics may be reduced if an injection is made into an inflamed or infected area. Repeated doses of lidocaine may cause significant increases in blood levels with each repeated dose because of slow accumulation of the drug or its metabolites. Tolerance to elevated blood levels varies with the status of the patient. Careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness should be accomplished after each local anaesthetic injection.
","Dosages in children should be reduced, commensurate with age, body-weight and physical condition. Elderly patients may be more sensitive to systemic effects and may require dose reductions.
",,,,"Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+684,Lidocaine + Prilocaine,lidocaine-prilocaine-684,https://medex.com.bd/attachments/C1iRZ23WV96MAsnAO2O8ZLoxdAmxXw/lidocaine-prilocaine-prescribing-information,Local & Surface anesthesia,,"Indicated as a topical anesthetic for use on normal intact skin for local analgesia, genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia
","Local & Surface anesthesia, Topical Local Anesthetics
","Lidocaine and prilocaine are local anaesthetic agents of the amide type. Both work by stabilising the neuronal membranes and inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby giving rise to the anaesthetic action.
","A thick layer of Lidocaine & Prilocaine cream is applied to intact skin and covered with an occlusive dressing.
Minor Dermal Procedures: For intravenous cannulation and venipuncture, apply 2.5 grams of Lidocaine & Prilocaine cream over 20-25 cm
2 of skin surface for at least 1 hour.
Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area, apply 2 grams of Lidocaine & Prilocaine cream per 10 cm
2 of skin and allow to remain in contact with the skin for at least 2 hours.
Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of Lidocaine & Prilocaine cream to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of Lidocaine & Prilocaine cream.
Adult Female Genital Mucous Membranes: For minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5-10 grams) of Lidocaine & Prilocaine cream for 5 to 10 minutes. Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the Lidocaine & Prilocaine cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of Lidocaine & Prilocaine cream.
Pediatric Patients: The following are the maximum recommended doses, application areas and application times for Lidocaine & Prilocaine cream based on a child’s age and weight:
+
+- 0 to 3 months or <5 kg: Maximum Total Dose 1 gm, Maximum Application Time: 1 hour
+- 3 to 12 months and >5 kg: Maximum Total Dose 2 gm, Maximum Application Time 4 hour
+- 1 to 6 years and >10 kg: Maximum Total Dose 10 gm, Maximum Application Time 4 hour
+- 7 to 12 years and >20 kg: Maximum Total Dose 20 gm, Maximum Application Time 4 hour
+
",,"Cream should be used with caution in patients receiving antiarrhythmic drugs, such as tocainide, since the toxic effects are additive.
","Hypersensitivity to local anaesthetics of the amide type or to any other component of the product.
","Nervousness, dizziness, blurred vision, tremors, drowsiness, convulsions, unconsciousness, respiratory arrest, hypotension, myocardial depression, bradycardia, cardiac arrest and anaphylactoid reactions (cutaneous lesion, urticaria, oedema).
","There is no, or inadequate, evidence of safety of the drug in human pregnancy but it has been in wide use for many years without apparent ill consequence. If drug therapy is needed in pregnancy, this drug can be used if there is no safer alternative. Cream enters the mothers milk, but in such small quantities that there is generally no risk of affecting the child at therapeutic dose levels.
","Absorption from wound surfaces and mucous membranes is relatively high, especially in the bronchial tree. This cream should be used with caution in patients with traumatised mucosa and/or sepsis in the region of the proposed application. If the dose or site of administration is likely to result in high blood levels, cream should be used cautiously in patients with epilepsy, impaired cardiac condition, bradycardia, impaired hepatic function and in severe shock. The use of oropharyngeal topical anesthetic agents may interfere with swallowing and thus enhance the danger of aspiration. This is particularly important in children because of their frequency of eating. Numbness of the tongue or buccal mucosa may increase the danger of biting trauma.
",,"Toxic levels of lidocaine (>5 µg/ml) and/or prilocaine (>6 µg/ml) may decrease cardiac output, total peripheral resistance and mean arterial pressure. These changes are due to direct depressant effects of these local anaesthetic agents on the CVS.
",,,"Store in a cool and dry place, protected from light
",11
+1222,Lidocaine + Epinephrine,lidocaine-epinephrine-1222,https://medex.com.bd/attachments/eLXwmlOporpaXoJqjRPkvWbuo2Bj4x/lidocaine-epinephrine-prescribing-information,Local & Surface anesthesia,Dental infiltration anesthesia,"This is indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.
","Local & Surface anesthesia
","Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of nerve impulses, thereby effecting local anesthetic action.
Epinephrine works via the stimulation of alpha and beta-1 adrenergic receptors, and a moderate activity at beta-2 adrenergic receptors.
","Adult: For normal healthy adults, the amount of lidocaine HCl administered should be kept below 500 mg, and in any case, should not exceed 7 mg/kg (3.2 mg/lb) of body weight.
Pediatric: Dosages in pediatric population should be reduced, commensurate with age, body weight and physical condition. It is difficult to recommend a maximum dose of any drug for pediatric patients since this varies as a function of age and weight. For pediatric patients of less than ten years who have a normal lean body mass and normal body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark's rule). For example, in pediatric patients of five years weighing 50 Ibs, the dose of lidocaine hydrochloride should not exceed 75-100mg when calculated according to Clark's rule. In any case, the maximum dose of lidocaine hydrochloride should not exceed 7 mg/kg (3.2 mg/lb) of body weight.
",,,"This contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to any components of the injectable formulations.
",,"Pregnancy Category B. Reproduction studies have been performed in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. There are, however, no adequate and well-controlled studies in pregnant women. Animal reproduction studies are not always predictive of human response. General consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.
Nursing Mother: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lidocaine is administered to a nursing woman.
",,,,,,"Store at controlled room temperature, below 25°C
",7
+33,Lidocaine + Adrenaline,lidocaine-adrenaline-33,https://medex.com.bd/attachments/W1twZG62L5uzg3UKZqRErc4AWahBN1/lidocaine-adrenaline-prescribing-information,Local & Surface anesthesia,Sympathetic nerve block,"This drug is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.
","Local & Surface anesthesia
","Lidocaine is a local anaesthetic which decreases permeability of sodium ions, blocking induction and conduction of nerve impulses. Combination with epinephrine restricts systemic spread of lidocaine, vascular absorption and its duration of local anaesthetic effect.
","Dosage depends on several factors such as route, type and extent of surgical procedure, duration of anaesthesia and patient's condition and age.
Adult: Max dose of lidocaine given with epinephrine: 7 mg/kg and not >500 mg.
Child: 3 mth-12 yr: Max dose 3 mg/kg. Ideal body weight should be used in children with high body weight.
",,"Halogenated inhalation anaesthetics; alpha or beta blocking agents; methyldopa, guanethidine; drugs with vasoconstrictor and pressor effects; antihypertensives; adrenergic neuron blockers; potassium-depleting drugs; cardiac glycosides; ephedra, yohimbe. TCAs may induce hypertension and arrhythmia.
","Tachycardia, hypertension, cerebral arteriosclerosis, ischaemic heart disease, IV admin, anaesthetise digits or appendages, myasthenia gravis.
","More common side effects: Minor redness, burning, irritation, or numbness at the application site; lightheadedness; nausea.
Severe side effects: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; dizziness; fainting; fast, slow, or irregular heartbeat; loss of consciousness; mental or mood changes; nervousness; paleness; redness or warmth of skin; ringing in the ears or hearing changes; seizures; sensation of heat or cold; shortness of breath; swelling or blistering of skin; tremors or twitching; vision changes or double vision; vomiting.
","Pregnancy Category C+B. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using epinephrine/lidocaine iontophoretic patch while you are pregnant. Epinephrine/lidocaine iontophoretic patch is found in breast milk. If you are or will be breast-feeding while you use epinephrine/lidocaine iontophoretic patch, check with your doctor. Discuss any possible risks to your baby.
","Epilepsy, impaired cardiac conduction, CHE DM, closed angle glaucoma, impaired liver function (if site of admin is likely to result in high blood levels), severe renal dysfunction. Local anaesthetic effect may be reduced if injected into an inflamed or infected area. Cerebrovascular insufficiency, hyperthyroidism. Neonates, elderly, patients in poor general condition (optimise patient's condition before major block), pregnancy.
",,,,"Can be diluted if necessary in glucose 5%, sodium chloride 0.9% and lactated Ringer's solution.
","Store at room temperature, between 20℃ to 25℃. Store away from heat and light. Keep the child-resistant envelope sealed at all times when not in use. Keep out of the reach of children and away from pets.
",11
+1174,Levothyroxine Sodium,levothyroxine-sodium-1174,https://medex.com.bd/attachments/ia44kLtBUcAMGa0CDuaRWy0uyEEM6t/levothyroxine-sodium-prescribing-information,Thyroid drugs & hormone,Hypothyroidism,"
+- As replacement therapy in hypothyroidism of any aetiology. Replacement therapy should not be instituted in transient hypothyroidism during the recovery phase of subacute Thyroiditis.
+- For the suppression of Thyroid Stimulating Hormone (TSH) levels in the presence of goitres, nodules and after radiological and/or surgical treatment of Thyroid cancer.
... Read more
+- As replacement therapy in hypothyroidism of any aetiology. Replacement therapy should not be instituted in transient hypothyroidism during the recovery phase of subacute Thyroiditis.
+- For the suppression of Thyroid Stimulating Hormone (TSH) levels in the presence of goitres, nodules and after radiological and/or surgical treatment of Thyroid cancer.
+- For the suppression of the goitrogenic effects of other drugs such as Lithium.
+- As a diagnostic aid in suppression tests.
+
","Thyroid drugs & hormone
","This tablet contains synthetic Levothyroxine (also called Thyroxine or T4) which is identical to the natural hormone T4, produced in the Thyroid gland. About 30% of T4 is converted to the much more active Triiodothyronine (T3) in peripheral tissues. TBG (Thyroxine Binding Globulin) is the major carrier of T4. This binding protects T4 from metabolism and excretion resulting in its long half-life in the circulation. Only about 0.03% of total T4 in plasma is unbound. The half-life of elimination of T4 is 6 to 7 days. In hyperthyroidism, the half-life is shortened to 3 or 4 days, whereas in hypothyroidism it may be 9 to 10 days. In conditions associated with reduced protein in plasma as in nephrosis or hepatic cirrhosis or when binding to protein is inhibited by certain drugs the half-life of T4 may be shortened. The liver is the major site of degradation of Thyroid hormones. T4 is conjugated with Glucuronic and Sulphate conjugates through the Phenolic hydroxyl group and excreted in the urine.There is an enterohepatic circulation of the Thyroid hormones, since they are liberated by hydrolysis in the intestine and reabsorbed. Because of the long half-life of T4, a steady blood level of the biologically more active T3 can be obtained from one single daily dose of Levothyroxine. Therefore, variations in the therapeutic effect are unlikely once the correct dosage has been established.
","Adult dose:
+
+- Initial starting dose: 25-50 mcg/day, with gradual increments in dose at 6-8 week intervals, as needed. The Levothyroxine Sodium dose is generally adjusted in 12.5-25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.
+- In patients with severe hypothyroidism: Initial dose is 12.5-25 mcg/day with increases of 25 mcg/day every 2-4 weeks, accompanied by clinical and laboratory assessment,until the TSH level is normalized.
+- In patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism: Levothyroxine Sodium dose should be titrated until the patient is clinically euthyroid and the serum free - T4 level is restored to the upper half of the normal range.
+- For patients older than 50 years or for patients under 50 years of age with underlying cardiac disease: 1.7 mcg/kg/day.
+
+
Pediatric Dosage (Newborns): The recommended starting dose is 10-15 mcg/kg/day. A lower starting dose should be considered in infants at risk for cardiac failure and the dose should be increased in 4-6 weeks as needed based on clinical and laboratory response to treatment. In infants with very low (<5 mcg/dL) or undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day of Levothyroxine Sodium.
Pediatric Dosage (Infants and Children): In children with chronic or severe hypothyroidism, initial dose of 25 mcg/day with increments of 25 mcg every 2-4 weeks until the desired effect is achieved. Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose and the dose is then increased on a weekly basis by an amount equal to one-fourth the full recommended replacement dose until the full recommended replacement dose is reached.
+
+- 0-3 months: 10-15 mcg/kg/day
+- 3-6 months: 8-10 mcg/kg/day
+- 6-12 months: 6-8 mcg/kg/day
+- 1-5 years: 5-6 mcg/kg/day
+- 6-12 years: 4-5 mcg/kg/day
+- >12 years but growth and puberty incomplete: 2-3 mcg/kg/day
+- Growth and puberty complete: 1.7 mcg/kg/day.
+
+The dose should be adjusted based on clinical response and laboratory parameters.
",,"Concurrent use of tri/tetracyclic antidepressants and Levothyroxine may increase the therapeutic and toxic effects of both drugs, possibly due to increased receptor sensitivity to catecholamines.Toxic effects may include increased risk of cardiac arrhythmias and CNS stimulation; onset of action of tricyclics may be accelerated. Administration of sertraline in patients stabilized on Levothyroxine may result in increased Levothyroxine requirements. Addition of Levothyroxine to antidiabetic or insulin therapy may result in increased antidiabetic agent or insulin requirements. Careful monitoring of diabetic control is recommended, especially when thyroid therapy is started, changed, or discontinued. Serum digitalis glycoside levels may be reduced in hyperthyroidism or when the hypothyroid patient is converted to the euthyroid state. Therapeutic effect of digitalis glycosides may be reduced.
","
+- Untreated subclinical or overt Thyrotoxicosis of any etiology
+- Acute Myocardial Infarction
+- Uncorrected Adrenal failure.
+
","Adverse reactions associated with Levothyroxine therapy are primarily those of hyperthyroidism due to therapeutic overdose. They include the following:
+
+- General: Fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating;
+- Central nervous system: Headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia.
+- Musculoskeletal: Tremors, muscle weakness.
+- Cardiovascular: Palpitations, tachycardia, arrhythmias, increased pulse and blood pressure
+- Respiratory: Dyspnea.
+- Gastrointestinal: Diarrhea, vomiting, abdominal cramps.
+- Dermatologic: Hair loss, flushing.
+
","Pregnancy Category A. Pregnancy may increase Levothyroxine requirements. Although Thyroid hormones are excreted only minimally in human milk,caution should be exercised when it is administered to a nursing woman.However, adequate replacement doses of Levothyroxine are generally needed to maintain normal lactation.
","
+- In patients whose hypothyroidism is due to a decrease in pituitary gland function, there may also be adrenocortical insufficiency;before starting Levothyroxine therapy, this should be treated by adequate replacement with Corticosteroids to prevent acute adrenal insufficiency.
+- The choice of the starting dose and of any increases in dosing should be made with great care in patients with cardiovascular disease and/or severe and long-existing hypothyroidism.Too high an initial dose or too rapid an increase in dosing may lead to development or worsening of angina complaints, arrhythmias, myocardial infarction, cardiac failure or to sudden increase in blood pressure, especially in older patients.
+- Any marked change of body weight during treatment with T4 requires adjustment of the dosage.
+- When monitoring blood levels of T3 and T4, it should be borne in mind that a ""high"" normal to slightly increased T4 level will be necessary in order to obtain a normal level of T3. The correct dosage of Levothyroxine in primary hypothyroidism should generally be established by monitoring the serum level of TSH to see whether it has normalized. Because intoxication with Thyroid preparations may have serious consequences.
+
",,"The signs and symptoms of overdose are those of hyperthyroidism - agitation, confusion, irritability, hyperactivity, headache, sweating, mydriasis, tachycardia, arrhythmias, tachypnoea, pyrexia, increased bowel movements and convulsions. Cerebral embolism, shock, coma, and death have been reported. Symptoms may not necessarily be evident or may not appear until several days after ingestion of Levothyroxine Sodium. Dose of Levothyroxine Sodium should be reduced or temporarily discontinued if signs or symptoms of overdosage occur. Treatment is symptomatic.
",,,"Store below 30°C and dry place, protect from light. Keep out of the reach of children.
",11
+683,Levosalbutamol (Oral),levosalbutamol-oral-683,,Short-acting selective & β2-adrenoceptor stimulants,COPD,"Levosalbutamol is indicated for the treatment or prevention of bronchospasm in adults, adolescents and children 6 years of age and older with reversible obstructive airway disease.
","Short-acting selective & β2-adrenoceptor stimulants
","Levosalbutamol is a single isomer beta 2-agonist that differs from racemic salbutamol by elimination of (S)-salbutamol. Levosalbutamol is an effective bronchodilator whose primary mechanism of action is unimpeded by (S)-salbutamol. Thus, when compared with racemic salbutamol, clinically comparable bronchodilation can be achieved with doses that substantially lessen beta-mediated side effects.
","Tablet-
+
+- Adults and adolescents above 12 years: 1-2 mg three times daily.
+- Children (6 -11 years): 1 mg three times daily.
+
+Syrup-
+
+- Adults : 5-10 ml three times daily.
+- Childrn (6-11 years): 5 ml three times daily.
+
",,"Other short acting sympathomimetic bronchodilators or epinephrine should be used with caution with Levosalbutamol. If additional adrenergic drugs are to be administered by any route, they will be used with caution to avoid deleterious cardiovascular effects.
","Levosalbutamol is contraindicated in patients with a history of hypersensitivity to levosalbutamol or any of its components.
","Hypocalcaemia, palpitation, fine tremors of the skeletal muscle and muscle cramps may occur. The other likely side effects are nausea, vomiting, burning substernal or epigastric pain and diarrhoea.
","The drug should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. It is not known whether Levosalbutamol is excreted in human milk. Caution should be exercised when oral Levosalbutamol is administered to a nursing woman.
","Particular caution is advised in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment with xanthine derivatives, steroids and diuretics. Serum potassium levels should be monitored in such situations.
",,"The expected symptoms with over dosage are those of excessive beta-adrenergic stimulation and the symptoms listed under side effects. In the event of serious poisoning, the stomach should be emptied and, if necessary, a beta-blocker administered with caution in patients with a history of bronchospasm.
",,,"Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.
",11
+1319,Levosalbutamol,levosalbutamol-1319,,Short-acting selective & β2-adrenoceptor stimulants,Severe bronchospasm,"Levosalbutamol Nebuliser Solution or Inhaler is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children with reversible obstructive airway disease.
","Short-acting selective & β2-adrenoceptor stimulants
","Levosalbutamol Nebuliser Solution is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of Levosalbutamol, the (R)-enantiomer of the drug substance racemic salbutamol. Levosalbutamol Hydrochloride is a relatively selective β2 adrenergic receptor agonist.
Activation of β2 adrenergic receptors on airway smooth muscle leads to the activation of adenylcyclase and to an increase in the intracellular concentration of cyclic AMP. This increase in cAMP leads to the activation of protein kinase A, which inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in relaxation. Levosalbutamol relaxes the smooth muscles of all airways, from the trachea to the terminal bronchioles. Levosalbutamol acts as a functional antagonist to relax the airway irrespective of the spasmogen involved, thus protecting against all bronchoconstrictor.
","Nebuliser Solution: This Nebuliser Solutions supplied in unit-dose ampoules and requires no dilution before administration by nebulization.
+
+- Children (6 months-11 years): The recommended dosage is 0.31 mg administered three times a day, by nebulization. Routine dosing should not exceed 0.63 mg three times a day.
+- Adults and Adolescents above 12 years old: The recommended starting dosage is 0.63 mg administered three to four times a day, every 6 to 8 hours, by nebulization.
+- Patients 12 years of age and older: With more severe asthma or patients who do not respond adequately: 0.63 mg of Levosalbutamol Nebuliser Solution may benefit from a dosage of 1.25 mg three times a day.
+
+
Inhaler: You should take your Levosalbutamol Inhaler as needed for an asthma attack at any time of day, with or without food, by taking 1-2 puffs up to 4 times daily and no more than 8 puffs in 24 hours. If you are using your Levosalbutamol Inhaler more than 3-4 times a week this may indicate that your asthma is not well controlled and you may need to review your medication. You can also use your Levosalbutamol Inhaler to prevent allergy or exercise induced asthma by taking 2 puffs 15 minutes before exercise or exposure to a known allergen.
","Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.
Following simple steps can help to use Inhaler effectively (According to ""
National Asthma Guidelines for Medical Practitioners"" published by Asthma Association):
+
+- Take off the cap.
+- Shake the inhaler (at least six times) vigorously before each use.
+- If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
+- Breathe out as full as comfortably possible & hold the inhaler upright.
+- Place the actuator into mouth between the teeth and close lips around the mouthpiece.
+- While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
+- Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
+- If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
+- After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
+- Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.
+
+
Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.
","Other short-acting sympathomimetic aerosol bronchodilators or epinephrine should be used with caution with Levosalbutamol. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.
Beta-blockers: Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists such as Levosalbutamol Nebuliser Solution or Inhaler, but may also produce severe bronchospasm in asthmatic patients. However, under certain circumstances, e.g. prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. In this setting, cardio selective beta-blockers could be considered with caution.
Diuretics: The ECG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics can be acutely worsened by beta-agonists when the recommended dose of the beta-agonist is exceeded.
Digoxin: It is necessary to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and Levosalbutamol Nebuliser Solution or Inhaler.
Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: Levosalbutamol Nebuliser Solution or Inhaler should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents.
",,"Potentially serious hypokalaemia may result from beta 2 - agonist therapy. This effect may be potentiated by hypoxia. Other side effects such as palpitation, fine tremors of the skeletal muscle (particularly the hand) and muscle cramps may occur. In few cases nervousness, headache, dizziness, fatigue and sleeplessness have also been reported.
","Pregnancy: There are no adequate and well-controlled studies of Levosalbutamol Nebuliser Solution in pregnant women. Levosalbutamol Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is not known whether Levosalbutamol is excreted in human milk. Caution should be exercised when Levosalbutamol Nebuliser Solution is administered to a nursing woman.
","Levosalbutamol Hydrochloride, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, hypertension, and cardiac arrhythmias; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines. Levosalbutamol Nebuliser Solution or Inhaler must not be injected.
",,"The expected symptoms with over dosage are those of excessive beta-adrenergic receptor stimulation and/or occurrence or exaggeration of any of the symptoms listed under side effects. Treatment consists of discontinuation of Levosalbutamol Nebuliser Solution or Inhaler together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered.
",,,"Store below 25°C. Protect from light. Do not refrigerate.
",11
+681,Levonorgestrel,levonorgestrel-681,https://medex.com.bd/attachments/L0JQjW8eXQT9yGwDGqGUz8VG1JkjdN/levonorgestrel-075-mg-tablets-prescribing-information,Emergency Contraceptive Pill,Oral contraceptives,"Emergency contraception is a rescue method that is aimed to prevent fertilization in case of unprotected intercourse.
This contraception must be used as soon as possible, preferably within 12 hours and no later than 72 hours (3 days) after the unprotected sexual intercourse, particularly;
... Read more
Emergency contraception is a rescue method that is aimed to prevent fertilization in case of unprotected intercourse.
This contraception must be used as soon as possible, preferably within 12 hours and no later than 72 hours (3 days) after the unprotected sexual intercourse, particularly;
+
+- if you have had sexual intercourse whereas either yourself or your partner did not use a contraceptive method;
+- if you have forgotten to take consecutive 3 contraceptive pills;
+- if your partner's condom has broken, slipped, or been improperly removed, or if he has forgotten to use it;
+- if you fear that your intrauterine device has been expelled;
+- if your vaginal diaphragm or your contraceptive cap has moved or if you have removed it too early;
+- if you are afraid that the method of coitus interruptus has failed or if you have had sexual intercourse during the period when you are supposed to be fertile while using the rhythm method;
+- in the event of rape.
+
","Emergency Contraceptive Pill, Oral Contraceptive preparations
","Oral contraceptives containing levonorgestrel suppress gonadotropins, inhibiting ovulation. Specifically, levonorgestrel binds to progesterone and androgen receptors and slows the release of gonadotropin-releasing hormone (GnRH) from the hypothalamus. This process results in the suppression of the normal physiological luteinizing hormone (LH) surge that precedes ovulation. It inhibits the rupture of follicles and viable egg release from the ovaries. Levonorgestrel has been proven to be more effective when administered before ovulation.
","1.5 mg Tablet: The treatment necessitates the intake of one tablet. The Levonorgestrel tablet must be taken as soon as possible, preferably within 12 hours, after the unprotected intercourse, and no longer than within 72 hours (3 days) after the intercourse. Levonorgestrel can be taken at any moment during the menstrual cycle.
0.75 mg Tablet: The first Levonorgestrel tablet must be taken within 72 hours of the intercourse and the second tablet should be taken after 12 hours of the intake of the first tablet. Levonorgestrel must be taken within 48 hours of unprotected intercourse and in no way after 72 hours because the effectiveness of the medicine starts reducing after 48 hours of intercourse. Levonorgestrel can be taken at any moment during the menstrual cycle.
After using emergency contraception, it is recommended to use a local contraceptive mean (condom, spermicide, and cervical cap) until the next menstrual period resumes. The use of Levonorgestrel does not contraindicate the continuation of regular hormonal contraception. If you have used this medicine while you were using oral contraception (contraceptive pill), you should carry on taking the usual tablets until the end of the treatment. In case no menstrual period occurs in the next pill-free period following the use of Levonorgestrel a pregnancy test should be performed to rule out a pregnancy.
","Oral use. The tablet should be taken with a glass of water.
","Interactions with other medicines and other forms of interaction: Simultaneous administration of certain anticonvulsant agents (phenobarbitone, phenytoin, primidone, carbamazepine), also other medications such as rifampicin, and griseofulvin can reduce or suppress the effectiveness of this emergency contraception.
","If you have hypersensitivity to levonorgestrel or any of the excipients of Levonorgestrel.
","Undesirable effects which have been observed are:
+
+- Nausea and vomiting
+- Dizziness, fatigue, headache
+- Abdominal pain
+- A feeling of breast tenderness
+- Bleeding can occur after taking this medicine
+
+Inform the doctor of any unwanted effect which is not mentioned here.
","This medicine is not indicated in case of pre-existing pregnancy and cannot interrupt it. In case of failure of this contraceptive mean persisting pregnancy, epidemiological studies indicate no adverse effects of progestogen on the malformation of a fetus. Lactation is possible. However, since levonorgestrel is secreted into breast milk, it is suggested that you breastfeed immediately before taking each Levonorgestrel tablet and that you skip the nursing following each Levonorgestrel administration.
","Emergency contraception must be used exceptionally, since:
+
+- It does not allow to prevent a pregnancy in every instance:
+- The associated hormonal overdosing is not advisable in the case of regular intake.
+- It cannot replace regular contraception.
+
+After taking Levonorgestrel, the menstrual period usually occurs at the expected date nevertheless, it can occur earlier or later by a few days. After taking this medicine, it is therefore mandatory to check the absence of pregnancy by performing a pregnancy test in case of abnormal bleeding at the date of excepted menses or in case of menstrual delay of more than 5 days.
The use of emergency contraception does not replace the necessary precautions against sexually transmitted diseases and the measures to be taken in case of risk of transmission.
Taking this medicine is not recommended if you have had an ectopic pregnancy or if you have had salpingitis or if you have a severe digestive disease that impairs the absorption of medications.
If vomiting would occur within three hours after taking this medicine, it is recommended to take immediately another Levonorgestrel tablet.
",,"No acute toxicity has been demonstrated with this medicine in the case of intake of several doses. The efficacy of this medicine is not guaranteed if the dose has been omitted.
",,,"Do not exceed the expiry date printed on the outer packaging. Keep the tablet in the outer carton. Keep the medicine away from children. Store in cool dry conditions (below 30° C).
",12
+1881,Levomilnacipran Hydrochloride,levomilnacipran-hydrochloride-1881,https://medex.com.bd/attachments/fMkiNwH7DYzMudQSyzbJuR8Gmo7kEt/levomilnacipran-hydrochloride-prescribing-information,Serotonin-norepinephrine reuptake inhibitor (SNRI),Major depressive disorder,"Levomilnacipran is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of Major Depressive Disorder (MDD) in adults.
Limitation of Use: Levomilnacipran is not approved for the management of fibromyalgia. The efficacy and safety of Levomilnacipran for the management of fibromyalgia have not been established.
","Serotonin-norepinephrine reuptake inhibitor (SNRI)
","The exact mechanism of the antidepressant action of levomilnacipran is unknown, but is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous system, through inhibition of reuptake at serotonin and norepinephrine transporters. Non-clinical studies have shown that levomilnacipran is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI).
Levomilnacipran binds with high affinity to the human serotonin (5-HT) and norepinephrine (NE) transporters (Ki = 11 and 91 nM, respectively) and potently inhibits 5-HT and NE reuptake (IC50 = 16-19 and 11 nM, respectively). Levomilnacipran lacks significant affinity for any other receptors, ion channels or transporters tested in vitro, including serotonergic (5HT1-7), α- and β-adrenergic, muscarinic, or histaminergic receptors and Ca2+, Na+, K+ or Cl- channels. Levomilnacipran did not inhibit monoamine oxidase (MAO).
","Recommended dose: 40 mg to 120 mg once daily with or without food. Initiate dose at 20 mg once daily for 2 days and then increase to 40 mg once daily. Based on efficacy and tolerability, increase dose in increments of 40 mg at intervals of 2 or more days. The maximum recommended dose is 120 mg once daily. Take capsules whole; do not open, chew or crush.
Renal Impairment: Do not exceed 80 mg once daily for moderate impairment. Do not exceed 40 mg once daily for severe renal impairment.
Discontinuation: Reduce dose gradually whenever possible.
",,"Strong CYP3A4 inhibitors such as ketoconazole: Do not exceed 80 mg once daily.
","Hypersensitivity to levomilnacipran, milnacipran HCl or to any excipient in the formulation.
The use of MAOIs intended to treat psychiatric disorders with Levomilnacipran or within 7 days of stopping treatment with Levomilnacipran is contraindicated because of an increased risk of serotonin syndrome. The use of Levomilnacipran within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated.
Starting Levomilnacipran in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome.
","
+- Hypersensitivity
+- Suicidal Thoughts and Behaviors in Adolescents and Young Adults
+- Serotonin Syndrome
+- Elevated Blood Pressure
+- Elevated Heart Rate
+- Increased Risk of Bleeding
+- Angle Closure Glaucoma
+- Urinary Hesitation or Retention
+- Activation of Mania/Hypomania
+- Seizure
+- Discontinuation Syndrome
+- Hyponatremia
+
","Pregnancy: Third trimester use may increase risk for symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor, irritability) in the neonate.
",,"Pediatric Use: Clinical studies on the use of Levomilnacipran in pediatric patients have not been conducted; therefore, the safety and effectiveness of Levomilnacipran in the pediatric population have not been established. Levomilnacipran is not approved for use in pediatric patients.
Geriatric Use: No dose adjustment is recommended on the basis of age. In a multiple-dose clinical pharmacokinetic study, elderly subjects (> 65 years) had a slightly higher exposure (C max by 24% and AUC by 26%) of levomilnacipran than younger subjects (18-45 years). Of the total number of subjects in the 8-week clinical studies of Levomilnacipran, 2.8% of patients were age 65 or older. Because levomilnacipran is predominately excreted by the kidney, renal clearance of levomilnacipran should be considered when determining the dose. SSRIs and SNRIs, including Levomilnacipran, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event.
Hepatic Impairment: Hepatic elimination of levomilnacipran is low. Dose adjustment is not recommended in subjects with mild (Child-Pugh score of 1-6), moderate (Child-Pugh score of 7-9), or severe (Child-Pugh score of 10-13) hepatic impairment.
Renal Impairment: Renal excretion plays a predominant role in the elimination of levomilnacipran. Dose adjustment is not recommended for patients with mild (creatinine clearance of 60-89 ml/min) renal impairment. Dosing adjustment is recommended for patients with moderate (creatinine clearance of 30-59 ml/min) or severe (creatinine clearance of 15-29 ml/min) renal impairment. Levomilnacipran is not recommended for patients with end stage renal disease.
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+2037,Levomenthol + Thymol + Terpineol + Chlorobutanol,levomenthol-thymol-terpineol-chlorobutanol-2037,,,,"A head cold can hamper sleep, making for restless nights. Espirar’s combination of natural vapors from Levomenthol, Thymol, Chlorobutanol & Terpineol work gently to help you or your child breathe more easily.
",,,,,,,,,,,,,,,1
+680,Levofloxacin Hemihydrate,levofloxacin-hemihydrate-680,https://medex.com.bd/attachments/aMGN43P0uQSrNVzbUVrXdOQz0XwG2h/levofloxacin-hemihydrate-prescribing-information,4-Quinolone preparations,Urinary tract infection,"Levofloxacin is indicated for the treatment of mild, moderate and severe infections caused by susceptible strains of the designated micro-organisms in the condition listed below:
+
+- Acute maxillary sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
... Read more
Levofloxacin is indicated for the treatment of mild, moderate and severe infections caused by susceptible strains of the designated micro-organisms in the condition listed below:
+
+- Acute maxillary sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
+- Acute bacterial exacerbation of chronic bronchitis due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
+- Community-acquired pneumonia due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae.
+- Uncomplicated & complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus.
+- Acute pyelonephritis caused by Escherichia coli.
+- Uncomplicated & complicated skin and soft tissue infections including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to Staphylococcus aureus, Streptococcus pyogenes, Proteus mirabilis or Enterococcus faecalis.
+- Enteric infections caused by Enterobacter sp., Escherichia coli, Campylobacter sp., Vibrio cholerae, Shigella sp., Salmonella sp.
+
","4-Quinolone preparations
","Levofloxacin is a synthetic, broad-spectrum, third generation fluoroquinolone antibiotic. Chemically, Levofloxacin is a chiral fluorinated carboxyquinolone. Levofloxacin exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of gm-ve and gm+ve microorganisms.
","The usual dose of Levofloxacin Tablets is 250 mg or 500 mg or 750 mg administered orally every 24 hours. Levofloxacin tablets can be administered without regard to food. Levofloxacin oral solution should be taken 1 hour before, or 2 hours after eating.
Levofloxacin injection should only be administered by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration. The usual dose of Levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours. Since the Levofloxacin injections are for single-use only, any unused portion should be discarded. Additives or other medications should not be added to Levofloxacin Injection or infused simultaneously through the same intravenous line.
Adults:
+
+- Acute sinusitis: 500 mg once daily for 10-14 days, or 750 mg once daily for 5 days
+- Exacerbation of chronic bronchitis: 500 mg once daily for 7 days, or 750 mg once daily for 3 days (Uncomplicated), 750 mg once daily for 5 days (Complicated)
+- Community-acquired pneumonia: 500 mg once daily for 7-14 days, or 750 mg once daily for 5 days
+- Uncomplicated urinary-tract infections: 250 mg once daily for 3 days
+- Complicated urinary-tract infections and acute pyelonephritis: 250 mg once daily for 7-10 days
+- Uncomplicated skin and soft-tissue infections: 500 mg once daily for 7-10 days.
+- Complicated skin and soft-tissue infections: 750 mg once daily for 7-14 days.
+- Enteric fever: 500 mg once daily for 7-14 days.
+- Diarrhea, cholera, shigellosis & enteritis: Mild to moderate case: 500 mg (single dose). Moderate to sever case: 500 mg once daily for 3 days
+
+Children:
+
+- Children 6 months to <5 years: 10 mg/kg every 12 hours.
+- Children >5 years: 10 mg/kg every 24 hours
+
+In each case, sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
","Instructions for the Use of Levofloxacin Infusion-
+
+- Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution.
+- Do not use if the solution is cloudy or a precipitate is present.
+- Do not use flexible containers in series connections.
+- Close flow control clamp of administration set.
+- Remove cover from port at bottom of container.
+- Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
+- Suspend container from hanger.
+- Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levoxin Injection.
+- Open flow control clamp to expel air from set. Close clamp.
+- Regulate rate of administration with flow control clamp.
+
","No quinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line. Antacids, Iron and Adsorbents reduce absorption of Levofloxacin. NSAID may increase the risk of CNS stimulation. Warfarin may increase the risk of bleeding.
","Levofloxacin is contraindicated in patients with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product.
","Levofloxacin is generally well tolerated. However, a few side-effects can usually be seen. There is a risk of retinal detachment. Other side-effects include: nausea, vomiting, diarrhea, abdominal pain, flatulence and rare occurrence of phototoxicity (0.1%). Side-effects that may be seen very rarely include tremors, depression, anxiety, confusion etc.
","Levofloxacin is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.
","The following measures should be taken during administration of Levofloxacin:
+
+- Levofloxacin Injection should only be administered by slow intravenous infusion over a period of 60 or 90 minutes depending on the dosage.
+- While administrating Levofloxacin, adequate amount of water should be taken to avoid concentrated form of urine.
+- Dose adjustment should be exercised during Levofloxacin administration in presence of renal insufficiency.
+
",,"Levofloxacin exhibits a low potential for acute toxicity. However, in the events of an acute overdosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+1313,Levofloxacin (Ophthalmic),levofloxacin-ophthalmic-1313,https://medex.com.bd/attachments/WtNs0x2YxbxwI303tAmXBQOcBazzV3/levofloxacin-ophthalmic-15-ophthalmic-solution-prescribing-information,4-Quinolone preparations,Corneal ulcer,"Levofloxacin eye drops is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following bacteria:
Aerobic Gram-Positive bacteria-
+
+- Corynebacterium species
+- Staphylococcus oureus
+- Staphylococcus epidermidis
... Read more
Levofloxacin eye drops is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following bacteria:
Aerobic Gram-Positive bacteria-
+
+- Corynebacterium species
+- Staphylococcus oureus
+- Staphylococcus epidermidis
+- Streptococcus pneumoniae
+- Streptococcus (Groups C/F)
+- Streptococcus (Group G)
+- Streptococcus viridons group
+
+
Aerobic Gram-Negative bacteria-
+
+- Acinetobocter Iwoffii
+- Haemophilus influenzae
+- Serrotia morcescens
+
+Levofloxacin also provides a promising treatment for other ocular infections including- Bacterial corneal ulcer, Blepharitis, Hordeolum & Perioperative condition.
","4-Quinolone preparations
","Levofloxacin eye drops is a sterile topical ophthalmic solution. It is a synthetic, broad spectrum, third generation fluoroquinolone bactericidal antibiotic, which active against a broad spectrum of Gram-positive & Gram-negative ocular pathogens. It functions by inhibiting bacterial topoisomerase IV and DNA gyrase enzymes required for DNA replication, transcription, repair and recombination.
","0.5% eye drop: Adults and children 1 year of age and older:
+
+- Days 1 and 2: Instill 1-2 drops in the affected eye(s) every 2 hours while awake, up to 8 times per day.
+- Days 3 through 7: Instill 1-2 drops in the affected eye(s) every 4 hours while awake, up to 4 times per day.
+
+
1.5% eye drop: Adults and children 6 years of age and older:
+
+- Days 1 through 3: Instill one to two drops in the affected eye(s) every 30 minutes to 2 hours while awake and approximately 4 and 6 hours after retiring.
+- Day 4 through treatment completion: Instill one to two drops in the affected eye(s) every 1 to 4 hours while awake.
+
+
Children <1 year: Safety and effectiveness of Levofloxacin below 1 year of age have not been established.
",,"Specific drug interaction studies have not been conducted with levofloxacin eye drops. But the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine and enhance the effects of the oral anticoagulant warfarin and its derivatives.
","It is contraindicated in patients with a history of hypersensitivity to Levofloxacin, to other quinolones or to any of the components of this medication
","Side effects occurred only approximately 1-3% of patients that may include transient blurred vision, fever, foreign body sensation, headache, transient ocular burning, ocular pain or discomfort, pharyngitis and photophobia. In less than 1% of patients included allergic reactions, lid edema, ocular dryness and ocular itching.
","Pregnancy Category C. Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Levofloxacin has not been measured in human milk. Caution should be exercised when Levofloxacin eye drops is administered to a nursing mother.
","Prolonged use may result in the overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy.
",,,,,"Eye drops should be protected from light, store in a cool (15°-25° C) and dry place & keep out of reach of children.
",10
+198,Levodopa + Carbidopa + Entacapone,levodopa-carbidopa-entacapone-198,https://medex.com.bd/attachments/X3ahAL3bNOW1PO33BgaQ46rS8Z88Ld/levodopa-carbidopa-entacapone-prescribing-information,Antiparkinson drugs,Parkinson’s disease,"This medicine is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilized on levodopa/dopa decarboxylase (DDC) inhibitor treatment.
","Antiparkinson drugs
","Levodopa is the metabolic precursor of dopamine. It crosses the blood-brain barrier and is converted to dopamine in the brain. Carbidopa increases the amount of levodopa that is transported into the CNS by inhibiting the decarboxylation of peripheral levodopa. Entacapone is a selective inhibitor of COMT which alters the pharmacokinetics of levodopa, resulting to increased and more sustained levodopa serum levels.
","Adults: The optimum daily dose must be determined by careful titration of levodopa in each patient. Patients should be instructed to take only 1 (one) tablet per dose administration. The maximum recommended daily dose of entacapone is 2,000 mg. Usually this combination is to be used in patients who are currently treated with corresponding doses of standard release Levodopa or Dopa Decarboxylase (DDC) inhibitor and entacapone.
","May be taken with or without food. Keep a consistent diet. A change in diet to foods high in protein may delay levodopa absorption & reduce amount taken up in circulation. Excessive acidity also delays stomach emptying & thus delays levodopa absorption. Iron salts may also reduce amount of levodopa available to the body. Swallow whole.
","Symptomatic postural hypotension may occur when levodopa is added to the treatment of patients already receiving antihypertensive. Dose adjustment of the antihypertensive agent may be required. Dopamine receptor antagonists (e.g. some antipsychotics and antiemetics), phenytoin and papaverine may reduce the therapeutic effect of levodopa. Patients taking these medicinal products with levodopa/ carbidopa/ entacapone combination should be carefully observed for loss of therapeutic response. Since levodopa competes with certain amino acids, the absorption of Levodopa, Carbidopa & Entacapone may be impaired in some patients on high protein diet.
","Narrow-angle glaucoma, phaeochromocytoma, history of neuroleptic malignant syndrome (NMS) and/ or non-traumatic rhabdomyolysis. Severe hepatic impairment. Concurrent use of or within 14 days of discontinuing non-selective MAOIs.
","Common side effects include dyskinesia, nausea, hyperkinesia, change in urine color, diarrhea and stomach pain. Other side effects may include diarrhea, sometimes severe; colitis; hallucinations; other mental disturbances; orthostatic hypotension; rhabdomyolysis; and symptoms resembling neuroleptic malignant syndrome (a condition characterized by high fever, muscle stiffness, and confusion); fibrosis; skin cancer, etc.
","Pregnancy category C. The combination of levodopa/ carbidopa/ entacapone should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. The safety of this combination in the infant is not known. Women should not breast-feed during treatment with this combination.
","Levodopa, carbidopa and entacapone together may cause dizziness and symptomatic orthostatism. Therefore, caution should be exercised when driving or using machines. As with levodopa, periodic evaluations of hepatic, hematopoietic, cardiovascular and renal function are recommended during extended therapy.
","Children: Safety and effectiveness in pediatric patients have not been established.
Elderly: No dose adjustment is required for elderly patients.
Hepatic impaired patients: Should be administered cautiously to patients with mild to moderate hepatic impairment. Dose reduction may be needed.
Renally impaired patients: Should be administered cautiously to patients in severe renal impairment including those receiving dialysis therapy
","The acute symptoms and signs of overdose include agitation, confusional state, coma, bradycardia, ventricular tachycardia, Cheyne Stokes respiration, discolorations of skin, tongue and conjunctiva, and chromaturia. Management of acute overdose with levodopa/ carbidopa/ entacapone combination is similar to acute overdose with levodopa. Pyridoxine, however, is not effective in reversing the actions of levodopa/ carbidopa/ entacapone combination. Hospitalization is advised and general supportive measures should be employed with immediate gastric lavage and repeated doses of charcoal over time.
",,,"Store in a cool and dry place. Protect from light.
",13
+199,Levodopa + Carbidopa (FC tablet),levodopa-carbidopa-fc-tablet-199,https://medex.com.bd/attachments/XQfKtjrLhEXextojgCZRR2ENCt3MMR/levodopa-carbidopa-fc-tablet-prescribing-information,Antiparkinson drugs,Parkinson’s disease,"This tablet is indicated for the treatment of Parkinson's disease and syndrome. It is useful in relieving many of the symptoms of parkinsonism, particularly rigidity and bradykinesia. This tablet is frequently helpful in the management of tremor, dysphagia, sialorrhea and postural instability associated ... Read more
This tablet is indicated for the treatment of Parkinson's disease and syndrome. It is useful in relieving many of the symptoms of parkinsonism, particularly rigidity and bradykinesia. This tablet is frequently helpful in the management of tremor, dysphagia, sialorrhea and postural instability associated with Parkinson's disease and syndrome. Levodopa plus carbidopa before physiotherapy increases motor recovery after stroke.
","Antiparkinson drugs
",,"If 100/10 mg tablet is used: Dosage may be initiated with one tablet three or four times a day. Titration upward may be required in some patients to achieve optimum dosage of carbidopa. The dosage may be increased by one tablet every day or every other day until a total of eight tablets (two tablets q.d.s.) is reached.
For patients starting with 250/25 mg tablet: The initial dose is one half taken once or twice daily. However, this may not provide the optimal amount of Carbidopa needed by many patients. If necessary, add one-half every day or every other day until optimal response is reached. The suggested starting dosage for most patients taking more than 1500 mg of Levodopa a day is one tablet of 250/25 mg three or four times a day.
Maintenance dose: Therapy should be individualized and adjusted according to the desired therapeutic response. When more levodopa is requried, 250/25 mg tablet should be substituted at a dosage of one tablet three or four times a day. If necessary, the dosage of 250/25 mg tablet may be increased by half to one tablet every other day to a maximum of eight tablets a day. Experience with a total daily dosage greater than 200 mg Carbidopa is limited.
",,"Symptomatic postural hypotension has occurred when Carbidopa-Levodopa is added to the treatment of a patient receiving antihypertensive medicines. Therefore, when therapy with CarbidopaLevodopa is started, dosage adjustment of the antihypertensive medicine may be required. There have been rare reports of adverse reactions, including hypertension and dyskinesia, resulting from the concomitant use of tricyclic antidepressants and Carbidopa-Levodopa. Studies demonstrate a decrease in the bioavailability of Carbidopa and/or Levodopa when it is ingested with ferrous sulphate or ferrous gluconate. Dopamine-2 receptor antagonists (e.g., phenothiazines, butyrophenones and risperidone) and isoniazid may reduce the therapeutic effects of Levodopa. In addition, the beneficial effects of Levodopa in Parkinson's disease have been reported to be reversed by phenytoin and papaverine. Patients taking these medicines with Carbidopa-Levodopa should be carefully observed for loss of therapeutic response. Concomitant therapy with selegiline and Carbidopa-Levodopa may be associated with severe orthostatic hypotension not attributable to Carbidopa-Levodopa alone.
","Carbidopa-Levodopa tablet is contraindicated in patients with hypersensitivity to Carbidopa and Levodopa, and in patients with narrow-angle glaucoma. Since Levodopa may activate a malignant melanoma, Carbidopa-Levodopa should not be used in patients with suspicious undiagnosed skin lesions or a history of melanoma.
","Adverse effects that occur frequently in patients receiving Carbidopa-Levodopa are those due to the central neuropharmacologic activity of dopamine. These reactions usually can be diminished by dosage reduction. The most common adverse effects are dyskinesias including choreiform, dystonic, and other involuntary movements and nausea.
+
+- Body as a whole: syncope, chest pain, anorexia.
+- Cardiovascular: palpitation, orthostatic effects including hypotensive episodes, hypertension, phlebitis.
+- Gastrointestinal: vomiting, gastrointestinal bleeding, development of duodenal ulcer, diarrhoea, dark saliva.
+- Haemotologic: leukopenia, haemolytic and non-haemolytic anaemia, thrombocytopenia, agranulocytosis.
+- Hypersensitivity: angioedema, urticaria, pruritus, Henoch-Schonlein purpura.
+- Nervous System: dizziness, somnolence, paresthesia, delusions, hallucinations and paranoid ideation, depression with or without development of suicidal tendencies, dementia, dream abnormalities, agitation, confusion, increased libido.
+- Respiratory: dyspnea.
+- Skin: alopecia, rash, dark sweat.
+- Urogenital: dark urine.
+
","Although the effects of CarbidopaLevodopa on human pregnancy are unknown both Levodopa and combinations of Carbidopa and Levodopa have caused visceral and skeletal malformations in rabbits. Therefore, use of CarbidopaLevodopa in women of childbearing potential requires that the anticipated benefits of the medicine be weighed against possible hazards should pregnancy occur. It is not known whether Carbidopa is excreted in human milk. Because many medicines are excreted in human milk and because of the potential for serious adverse reactions in infants, a decision should be made whether to discontinue nursing or to discontinue the use of Carbidopa-Levodopa, taking into account the importance of the medicine to the mother.
","Carbidopa-Levodopa is not recommended for the treatment of medicine-induced extrapyramidal reactions. Carbidopa Levodopa may be given to patients already taking Levodopa alone; however, the Levodopa must be discontinued at least 12 hours before Carbidopa-Levodopa started. Dyskinesias may occur in patients previously treated with Levodopa alone because Carbidopa permits more Levodopa to reach the brain and, thus, more dopamine to be formed. The occurrence of dyskinesias may require dosage reduction. All patients should be observed carefully for the development of depression with concomitant suicidal tendencies. Patients with past or current psychoses should be treated with caution. Carbidopa-Levodopa should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, or a history of peptic ulcer disease or of convulsions.
Care should be exercised to patients with a history of myocardial infarction who have atriai, nodal, or ventricular arrhythmia. In such patients, cardiac function should be monitored with particular care during the period of initial dosage administration and titration. Patients with chronic wide-angle glaucoma may be treated cautiously with Carbidopa-Levodopa, provided the intraocular pressure is weli controlled and the patient monitored carefully for changes in intraocular pressure during therapy.
","Use in children: Safety and effectiveness of Carbidopa-Levodopa in infants and children have not been established, and its use in patients below the age of 18 years is not recommended.
",,,,"Store in a cool and dry place, protected from light.
",10
+1827,Levodopa + Carbidopa (CR tablet),levodopa-carbidopa-cr-tablet-1827,https://medex.com.bd/attachments/GAXgpzn6Oel97w5QxUzcYv9IYyLDS0/levodopa-carbidopa-cr-tablet-prescribing-information,Antiparkinson drugs,Protects from Parkinson's disease,"Idiopathic Parkinson's disease, in particular to reduce off-period in patients who previously have been treated with levodopa/decarboxylase inhibitors, or with levodopa alone and who have experienced motor fluctuations.
","Antiparkinson drugs
",,"Patients currently treated with conventional levodopa/decarboxylase inhibitor combinations: Dosage with Levodopa-Carbidopa prolonged-release tablet should be substituted initially at an amount that provides no more than approximately 10% more levodopa per day when higher dosages are given (more than 900 mg per day). The dosing interval between doses should be prolonged by 30 to 50% at intervals ranging from 4 to 12 hours. It is recommended to give the smaller dose, if divided doses are not equal, at the end of the day. The dose needs to be titrated further depending on clinical response, as indicated below under 'Titration'. Dosages that provide up to 30% more levodopa per day may be necessary. A guide for substitution of Levodopa Carbidopa prolonged-release tablet treatment for conventional levodopa/decarboxylase inhibitor combinations is shown in the table below:
Guideline for conversion from conventional Levodopa/Carbidopa tablet to Levodopa-Carbidopa prolonged-release tablet:Conventional tablet: Daily Dosage of Levodopa 300-400 mg
+
+- Controlled Release tablet: Daily Dosage of Levodopa 400 mg. Dosage Regimen: 1 tablet 2x daily.
+
+Conventional tablet: Daily Dosage of Levodopa 500-600 mg
+
+- Controlled Release tablet: Daily Dosage of Levodopa 600 mg. Dosage Regimen: 1 tablet 3x daily.
+
+Conventional tablet: Daily Dosage of Levodopa 700-800 mg
+
+- Controlled Release tablet: Daily Dosage of Levodopa 800 mg. Dosage Regimen: 4 tablets in 3 or 4 divided doses.
+
+Conventional tablet: Daily Dosage of Levodopa 900-1000 mg
+
+- Controlled Release tablet: Daily Dosage of Levodopa 1000 mg. Dosage Regimen: 5 tablets in 3 or more divided doses.
+
+Conventional tablet: Daily Dosage of Levodopa 1100-1200 mg
+
+- Controlled Release tablet: Daily Dosage of Levodopa 1200 mg. Dosage Regimen: 6 tablets in 3 or more divided doses.
+
+Conventional tablet: Daily Dosage of Levodopa 1300-1400 mg
+
+- Controlled Release tablet: Daily Dosage of Levodopa 1400 mg. Dosage Regimen: 7 tablets in 3 or more divided doses.
+
+Conventional tablet: Daily Dosage of Levodopa 1500-1600 mg
+
+- Controlled Release tablet: Daily Dosage of Levodopa 1600 mg. Dosage Regimen: 8 tablets in 3 or more divided doses.
+
","Patients currently treated with levodopa alone: Levodopa must be discontinued at least eight hours before therapy with this CR tablet is started. In patients with mild to moderate disease, the initial recommended dose is one tablet of this CR tablet twice daily.
Patients not receiving levodopa: In patients with mild to moderate disease, the initial recommended dose is one tablet of this CR tablet twice daily. Initial dosages should not exceed 600 mg per day of levodopa, nor be given at intervals of less than six hours.
Titration: Following initiation of therapy, doses and dosing intervals may be increased or decreased, depending upon therapeutic response. Most patients have been adequately treated with two to eight tablets per day of this CR tablet administered as divided doses at intervals ranging from four to twelve hours during the waking day. Higher doses (up to 12 tablets) and shorter intervals (less than four hours) have been used, but are not usually recommended. When doses of this CR tablet are given at intervals of less than four hours, or if the divided doses are not equal, it is recommended that the smaller doses be given at the end of the day. In some patients the onset of effect of the first morning dose may be delayed for up to one hour compared with the response usually obtained from the first morning dose of conventional levodopa-carbidopa tablet. An interval of at least three days between dosage adjustments is recommended.
Maintenance: Because Parkinson’s disease is progressive, periodic clinical evaluations are recommended and adjustment of the dosage regimen of this CR tablet may be required.
Addition of other antiparkinson medication: Anticholinergic agents, dopamine agonists and amantadine can be given with this CR tablet. Dosage adjustment of this CR tablet may be necessary when these agents are added to an existing treatment regimen for this CR tablet.
Interruption of therapy: Patients should be observed carefully if abrupt reduction or discontinuation of this CR tablet is required, especially if the patient is receiving antipsychotics.
","Caution should be exercised when the following drugs are administered concomitantly with Levodopa-Carbidopa prolonged-release tablet.
Antihypertensive agents: Symptomatic postural hypotension has occurred when levodopa/decarboxylase inhibitor combinations were added to the treatment of patients receiving some antihypertensive drugs. Therefore when therapy with Levodopa-Carbidopa prolonged-release tablet is started, dosage adjustment of the antihypertensive drug may be required.
Antidepressants: There have been rare reports of adverse reactions, including hypertension and dyskinesia, resulting from the concomitant use of tricyclic antidepressants and carbidopa-levodopa preparations.
Anticholinergics: Anticholinergics may affect the absorption and thus the patient’s response.
Iron: Studies demonstrate a decrease in the bioavailability of carbidopa and/or levodopa when it is ingested with ferrous sulphate or ferrous gluconate.
Other drugs: Dopamine D2 receptor antagonists (e.g. phenothiazines, butyrophenones and risperidone) and isoniazid may reduce the therapeutic effects of levodopa. The beneficial effects of levodopa in Parkinson’s disease have been reported to be reversed by phenytoin and papaverine. Patients taking these drugs with Levodopa-Carbidopa prolonged-release tablet should be observed carefully for loss of therapeutic response. Concomitant therapy with selegiline and carbidopa-levodopa may be associated with severe orthostatic hypotension not attributable to carbidopa-levodopa alone. Since levodopa competes with certain amino acids, the absorption of levodopa may be impaired in some patients on a high protein diet. The effect of simultaneous administration of antacids with Levodopa-Carbidopa prolonged-release tablet on the bioavailability of levodopa has not been studied.
","Levodopa-Carbidopa prolonged-release tablet should not be given when administration of a sympathomimetic amine is contraindicated. Non-selective monoamine oxidase (MAO) inhibitors are contraindicated for use with Levodopa-Carbidopa prolonged release tablet. These inhibitors must be discontinued at least two weeks prior to initiating therapy with Levodopa-Carbidopa prolonged release tablet. Levodopa-Carbidopa prolonged release tablet may be administered concomitantly with the manufacturer's recommended dose of an MAO inhibitor with selectivity for MAO type B (e.g. selegiline hydrochloride). Levodopa-Carbidopa prolonged release tablet is contraindicated in patients with known hypersensitivity to any component of this medication, and in patients with narrow-angle glaucoma. Because levodopa may activate a malignant melanoma, Levodopa-Carbidopa prolonged release tablet should not be used in patients with suspicious undiagnosed skin lesions or a history of melanoma.
","The side-effect reported most frequently was dyskinesia (a form of abnormal involuntary movements). A greater incidence of dyskinesias was seen with Levodopa-Carbidopa prolonged-release tablet than with Levodopa-Carbidopa tablet. Other side-effects: nausea, hallucinations, confusion, dizziness, chorea, dry mouth, dream abnormalities, dystonia, insomnia, depression, asthenia, vomiting, anorexia, chest pain, palpitation, constipation, diarrhoea, dyspepsia, gastro-intestinal pain, dark saliva, angioedema, urticaria, pruritus, weight loss, neuroleptic malignant syndrome, agitation, anxiety, decreased mental acuity, paraesthesia, disorientation, fatigue, headache, extrapyramidal and movement disorders, falling, gait abnormalities, muscle cramps, on-off phenomenon, increased libido, psychotic episodes, dyspnoea, flushing, alopecia, rash, dark sweat, blurred vision, dark urine, cardiac irregularities, hypertension, phlebitis, bitter taste, sialorrhoea, dysphagia, bruxism, hiccups, gastro-intestinal bleeding, flatulence, burning sensation of tongue, development of duodenal ulcer, leucopenia, haemolytic and non-haemolytic anaemia, thrombocytopenia, agranulocytosis.
","There are insufficient data to evaluate the possible harmfulness of this substance when used in human pregnancy. It is not known whether carbidopa is excreted in human milk. In a study of one nursing mother with Parkinson's disease, excretion of levodopa in breast milk was reported. Levodopa-Carbidopa prolonged-release tablet should not be given during pregnancy and to nursing mothers.
","When patients are receiving levodopa monotherapy, levodopa must be discontinued at least eight hours before therapy with Levodopa-Carbidopa prolonged-release tablet is started (at least 12 hours if slow-release levodopa has been administered). Dyskinesias may occur in patients previously treated with levodopa alone because carbidopa permits more levodopa to reach the brain and, thus, more dopamine to be formed. The occurrence of dyskinesias may require dosage reduction. Levodopa-Carbidopa prolonged-release tablet is not recommended for the treatment of drug-induced extrapyramidal reactions or for the treatment of Huntingdon’s chorea. Based on the pharmacokinetic profile of Levodopa-Carbidopa prolonged-release tablet the onset of effect in patients with early morning dyskinesias may be slower than with conventional Levodopa-Carbidopa tablet. The incidence of dyskinesias is slightly higher during treatment with Levodopa-Carbidopa prolonged-release tablet than with conventional Levodopa-Carbidopa tablet (16.5% vs 12.2%) in advanced patients with motor fluctuations. Levodopa-Carbidopa prolonged-release tablet should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, or with a history of peptic ulcer disease or of convulsions. Care should be exercised in administering Levodopa-Carbidopa prolonged-release tablet to patients with a history of recent myocardial infarction who have residual atrial, nodal, or ventricular arrhythmia. In such patients, cardiac function should be monitored with particular care during the period of initial dosage administration and titration. Levodopa has been associated with somnolence and episodes of sudden sleep onset. Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with levodopa. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. Furthermore a reduction of dosage or termination of therapy may be considered.
As with levodopa, Levodopa-Carbidopa prolonged-release tablet may cause involuntary movements and mental disturbances. Patients with a history of severe involuntary movements or psychotic episodes when treated with levodopa alone or levodopa/decarboxylase inhibitor combination should be observed carefully when Levodopa-Carbidopa prolonged-release tablet is substituted. These reactions are thought to be due to increased brain dopamine following administration of levodopa and use of Levodopa-Carbidopa prolonged-release tablet may cause recurrence. Dosage reduction may be required. All patients should be observed carefully for the development of depression with concomitant suicidal tendencies. Patients with past or current psychoses should be treated with caution. Impulse control disorders: Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa including Levodopa-Carbidopa tablet. Review of treatment is recommended if such symptoms develop.
","Use in Children: Safety and effectiveness of Levodopa-Carbidopa prolonged-release tablet in infants and children have not been established, and its use in patients below the age of 18 is not recommended.
",,,,"Store in a cool and dry place, protected from light.
",11
+700,Loteprednol Etabonate + Tobramycin,loteprednol-etabonate-tobramycin-700,https://medex.com.bd/attachments/iiK4rjw2J878xoK9d0jNB9R6pFlVIO/loteprednol-etabonate-tobramycin-prescribing-information,Ophthalmic steroid - antibiotic combined preparations,Ocular inflammation,"This is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva ... Read more
This is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis. It is also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. This is also indicated for the treatment of post-operative inflammation following ocular surgery.
","Ophthalmic steroid - antibiotic combined preparations
","Loteprednol is a corticosteroid which is thought to act by the induction of phospholipase A2 inhibitory proteins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.
Tobramycin is a member of aminoglycoside which shows bactericidal activity by inhibiting protein synthesis of bacteria.
","Shake well before use. Apply one drop into the conjunctival sac of the affected eye(s) every four to six hours. During the initial 24 to 48 hours, the dosing may be increased, to every one to two hours.
",,"Since Loteprednol Etabonate is not detected in plasma following the topical administration, it is not expected to affect the pharmacokinetics of systemically administered medicinal products.
","Contraindicated in most viral diseases of the cornea and conjunctiva. Also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
","Increased intraocular pressure, burning and stinging upon instillation, vision disorders, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder, and other unspecified eye disorders may occur. The incidence of non-ocular adverse events (headache) also reported.
","Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Loteprednol Etabonate & Tobramycin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: Caution should be exercised when Loteprednol Etabonate & Tobramycin is administered to a nursing mother.
","
+- For ophthalmic use only.
+- If this product is used for 10 days or longer, intraocular pressure should be monitored.
+- Fungal infections of the cornea are particularly prone to develop coincidentally with long-term use of steroid topically.
+- Prolonged use may result in overgrowth of nonsusceptible organisms including fungi. If superinfection occurs, appropriate therapy should be initiated.
+- Cross-sensitivity to other aminoglycoside antibiotics may occur.
+
","Use in children: Safety and effectiveness in pediatric patients have not been established.
",,,,"Store at room temperature & protect from light. Do not touch dropper tip to any surface. It is desirable that the contents should not be used four weeks after first opening of the bottle. Protect from freezing.
",11
+1321,Loteprednol Etabonate + Gatifloxacin,loteprednol-etabonate-gatifloxacin-1321,,Ophthalmic Steroid preparations,,"This ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral ... Read more
This ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, and cyclitis. It is also indicated for the treatment of post-operative inflammation following ocular surgery.
","Ophthalmic Steroid preparations
","Loteprednol (corticosteroids) are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Gatifloxacin is an 8-methoxyfluoroquinolone with a 3-methylpiperazinyl substituent at C7. The antibacterial action of gatifloxacin results from inhibition of DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription, and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division. The mechanism of action of fluoroquinolones including gatifloxacin is different from that of aminoglycoside, macrolide, and tetracycline antibiotics. Therefore, gatifloxacin may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to gatifloxacin. Gatifloxacin has been shown to be active against most isolates of the following organisms both microbiologically and clinically.
Aerobic Gram-Positive Bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae.
Aerobic Gram-Negative Bacteria: Haemophilus influenza.
","Apply one or two drops of sterile ophthalmic suspension into the conjunctival sac of the affected eye(s) every four to six hours. During the initial 24 to 48 hours, the dosing maybe increased, to every one to two hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.
",,"No drug interaction is reported yet. If several medicines are to be administered to the eye, there should be an interval of at least 5 minutes between each application.
","This sterile ophthalmic suspension is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex and also in mycobacterial infection of the eye and fungal diseases of ocular structures. It is also contraindicated in known hypersensitivity to any of the ingredients of this preparation. It is also contraindicated in patients with a history of hypersensitivity to other quinolones, acetylsalicylic acid and other no steroidal inflammatory medicines.
","Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component or the anti-infective component, or the combination. Reactions associated with ophthalmic steroids include elevated IOP, which may be associated with infrequent optic nerve damage, visual acuity and field detects, posterior sub capsular cataract formation, delayed wound healing, and secondary ocular infections from pathogens including herpes simplex, and perforation of the globe where there is thinning of cornea or sclera. The most frequently reported adverse effects for gatifloxacin in the overall study population were conjunctival irritation, increased lacrimation, keratitis and papillary conjunctivitis. These events occurred in approximately 5-10% of patients. Other reported reactions occurring in 1-4% of patients were chemosis, conjunctival hemorrhage, dry eye, eye discharge, eye irritation, eye pain, eyelid edema, headache, red eye, reduced visual acuity and taste disturbance. Redness was the most commonly observed adverse event occurring in 6%. Itching, discharge photophobia and blurred vision were seen in less than 2% cases.
","Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this is administered to a nursing woman.
","The preparation should not be injected sub conjunctively, nor should it be introduced directly into the anterior chamber of the eye. If this product is used for 10 days or longer, intraocular pressure should be monitored. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. If redness or itching becomes aggravated, the patient should be advised to consult a physician. Patients who wear soft contact lenses and whose eyes are not red, should be instructed to wait at least ten minutes after instilling it before they insert their contact lenses.
",,,,,"Store at room temperature & protect from light. Do not touch dropper tip to any surface. It is desirable that the contents should not be used one month after first opening of the bottle. Protect from freezing.
",10
+1575,Loteprednol Etabonate,loteprednol-etabonate-1575,https://medex.com.bd/attachments/QFQ5TZKLfUtggWAs2eSGIEN6VeNeUC/loteprednol-etabonate-prescribing-information,Ophthalmic Steroid preparations,,"Loteprednol ophthalmic gel: This is indicated for the treatment of post-operative inflammation and pain following ocular surgery. It is also effective in steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the eyeball such ... Read more
Loteprednol ophthalmic gel: This is indicated for the treatment of post-operative inflammation and pain following ocular surgery. It is also effective in steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the eyeball such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis & cyclitis.
Loteprednol ophthalmic suspension: This is indicated in steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the eyeball such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis & cyclitis. It is also effective in post-operative inflammation.
","Ophthalmic Steroid preparations
","Loteprednol is a corticosteroid which is thought to act by the induction of phospholipase A2 inhibitory proteins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.
","Loteprednol ophthalmic gel: Instill one to two drops of Ophthalmic Gel into the conjunctival sac of the affected eye four times daily beginning the day after surgery and continuing throughout the first 2 weeks of the postoperative period.
Loteprednol ophthalmic suspension:
+
+- For steroid-responsive ocular inflammation: Instill 1 drop of Ophthalmic Suspension into the conjunctival sac of the eye(s) four times a day.
+- For inflammation after surgery: Instill 1 drop of Ophthalmic Suspension into the conjunctival sac of the operated eye(s) four times a day beginning 24 hours after surgery and continuing throughout the first two weeks after surgery.
+
+Use in children: Safety and effectiveness in pediatric patients have not been established.
",,,"It is contraindicated in most viral diseases of the cornea and conjunctiva. It is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
","Glaucoma with optic nerve damage, visual acuity and field defects; cataract formation; secondary ocular infection following suppression of host response; and perforation of the globe may occur.
","No clinical data available for use in pregnancy. It is not known whether Loteprednol Etabonate passes into breast milk.
","For ophthalmic use only. If this product is used for 10 days or longer, intraocular pressure should be monitored. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term use of steroid topically. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and visual field, and in posterior subcapsular cataract formation. Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.
",,,,,"Protect from light. Store in cool & dry place. Keep out of the reach of children.
",9
+550,Losartan Potassium + Hydrochlorothiazide,losartan-potassium-hydrochlorothiazide-550,https://medex.com.bd/attachments/UAIo95TOA6cZ3f7U3NFs8wyvtJVA83/losartan-potassium-hydrochlorothiazide-prescribing-information,Combined antihypertensive preparations,Stroke,"This is indicated for the treatment of hypertension. It is also indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy.
","Combined antihypertensive preparations
","Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Losartan and its principal active metabolite block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that losartan is a reversible, competitive inhibitor of the AT1 receptor. Neither Losartan nor its active metabolite inhibits ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin); nor do they bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of Sodium and Chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in Aldosterone secretion, increases in urinary Potassium loss, and decreases in serum Potassium. The renin-aldosterone link is mediated by angiotensin II, so co-administration of an angiotensin II receptor antagonist tends to reverse the Potassium loss associated with these diuretics.
","Hypertension-
+
+- The usual starting dose of 50/12.5 is one tablet once daily.
+- For patients who do not respond adequately to one tablet the dosage may be increased to 100/25 once daily.
+- A patient whose blood pressure is not adequately controlled with Losartan 100 mg monotherapy may be switched to this combination 100/12.5 once daily.
+- In hypertensive patients with left ventricular hypertrophy initial dose is 50/12.5, if additional blood pressure reduction is needed, 100/12.5 may be given, followed by 100/25 if required. The maximum dose is 100/25 once daily.
+- In general, the antihypertensive effect is attained within three weeks after initiation of therapy.
+- No initial dosage adjustment of 50/12.5 is necessary for elderly patients. But maximum dose of 100/25 once daily dose should not be used as initial therapy in elderly patients.
+
+
Severe Hypertension:
+
+- The starting dose for initial treatment of severe hypertension is one tablet of 50/12.5 once daily.
+- For patients who do not respond adequately to this dose after 2 to 4 weeks of therapy, the dosage may be increased to 100/25 once daily. The maximum dose is one tablet of 100/25 once daily.
+
","This preparation may be administered with other antihypertensive agents. This may be administered with or without food.
","Losartan Potassium: No significant drug-drug pharmacokinetic interactions have been found in interaction studies with Hydrochlorothiazide, Digoxin, Warfarin, Cimetidine and Phenobarbital. As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g. Spironolactone, Triamterene, Amiloride), potassium supplements, or salt substitutes containing potassium may lead to increase in serum potassium. As with other antihypertensive agents, the antihypertensive effect of Losartan may be blunted by the non-steroidal anti-inflammatory drug Indomethacin.
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics: alcohol, barbiturates, or narcotics-potentiation of orthostatic hypotension may occur.
Antidiabetic drugs (oral agents and Insulin): dosage adjustment of the antidiabetic drug may be required.
Other antihypertensive drugs: additive effect or potentiation.
Cholestyramine and colestipol resins: absorption of Hydrochlorothiazide is impaired in the presence of anionic exchange resins
","The combination of Losartan and Hydrochlorothiazide is contraindicated in patients who are hypersensitive to any component of this product. Because of the Hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
","Side-effects are usually mild. Symptomatic hypotension including dizziness may occur, particularly in patients with intravascular volume depletion (e.g. those taking high-dose diuretics). Hyperkalaemia occurs occasionally; angioedema has also been reported with some angiotensin-II receptor antagonists. Vertigo; less commonly gastro-intestinal disturbances, angina, palpitation, oedema, dyspnoea, headache, sleep disorders, malaise, urticaria, pruritus, rash; rarely hepatitis, atrial fibrillation, cerebrovascular accident, syncope, paraesthesia; also reported pancreatitis, anaphylaxis, cough, depression, erectile dysfunction, anaemia, thrombocytopenia, hyponatraemia, arthralgia, myalgia, renal impairment, rhabdomyolysis, tinnitus, photosensitivity, and vasculitis (including Henoch-Schonlein purpura)
","Angiotensin-II receptor antagonists should be avoided in pregnancy unless essential. They may adversely affect fetal and neonatal blood pressure control and renal function; skull defects and oligohy dramnios have also been reported. Information on the use of angiotensin-II receptor antagonists in breastfeeding is limited. They are not recommended in breastfeeding and alternative treatment options, with better-established safety information during breastfeeding, are available.
","
+- Hypersensitivity: Angiooedema
+- Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals
+- Hypokalemia may rarely develop, especially with brisk diuresis, when severe cirrhosis is present, or after prolonged therapy
+- Impaired renal function and
+- Symptomatic hypotension
+
","Use in Patients with Renal Impairment: The usual regimens of therapy with 50/12.5 may be followed as long as the patient's creatinine clearance is >30 ml/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. In that case, hydrochlorothiazide is not recommended.
Use in Patients with Hepatic Impairment: The combination of Losartan and Hydrochlorothiazide is not recommended for titration in patients with hepatic impairment because the appropriate 25 mg starting dose of Losartan cannot be given.
Use in pediatric patients: The safety and effectiveness in pediatric patients have not been established.
","Losartan Potassium: Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Neither losartan nor its metabolite can be removed by hemodialysis.
Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia, may accentuate cardiac arrhythmias. The degree to which Hydrochlorothiazide is removed by hemodialysis has not been established.
",,,"Do not store above 30°C. Keep out of the reach of children.
",13
+699,Losartan Potassium,losartan-potassium-699,https://medex.com.bd/attachments/MIUVEPf5UMIaGq7e3zvFXKjyFOT5MK/losartan-potassium-prescribing-information,Angiotensin-ll receptor blocker,Stroke,"Hypertension: Losartan Potassium is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents (eg. thiazide diuretics).
Renal Protection in Type-2 Diabetic Patients with Proteinuria: Losartan Potassium ... Read more
Hypertension: Losartan Potassium is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents (eg. thiazide diuretics).
Renal Protection in Type-2 Diabetic Patients with Proteinuria: Losartan Potassium is indicated to delay the progression of renal disease in hypertensive type-2 diabetics with proteinuria, defined as urinary albumin to creatinine ratio >300 mg/g.
","Angiotensin-ll receptor blocker
","Losartan Potassium is the first non-peptide orally active angiotensin II receptor blocker. It binds to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland, kidneys and the heart) and reduces several important biological actions including vasoconstriction and the release of aldosterone responsible for hypertension.
","The usual starting and maintenance dose is 50 mg once daily for most patients. If the antihypertensive effect using 50 mg once daily is inadequate, 25 mg twice daily is recommended prior to increasing the dose. For patients with intravascular volume-depletion (e.g., those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered. Losartan Potassium can be administered once or twice daily. The total daily dose ranges from 25 mg to 100 mg.
",,"Rifampicin and fluconazole reduce levels of active metabolite of Losartan Potassium. Concomitant use of Losartan Potassium and hydrochlorothiazide may lead to potentiation of the antihypertensive effects. Concomitant use of potassium-sparing diuretics (eg, spironolactone, triamterene, amiloride), potassium supplements or salt substitutes containing potassium may lead to increases in serum potassium. The antihypertensive effect of losartan may be attenuated by the non-steroidal anti-inflammatory drug indomethacin. The use of ACE-inhibitor, angiotensin receptor antagonist, an anti-inflammatory drug and a thiazide diuretic at the same time increases the risk of renal impairment.
","Losartan Potassium is contraindicated in pregnant women and in patients who are hypersensitive to any component of this product. Losartan Potassium should not be administered with Aliskiren in patients with diabetes.
","The side effects with the use of Losartan Potassium are mild and transient in nature. The most common side effects are dizziness, diarrhea, nasal congestion, cough, upper respiratory infection. Other side effects are fatigue, oedema, abdominal pain, chest pain, nausea, headache & pharyngitis.
","Pregnancy Category D. The risk to the fetus increases if Losartan Potassium is administered during the second or third trimesters of pregnancy. It is not known whether Losartan Potassium is excreted in human milk, as many drugs are excreted in human milk and because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
","Use of Losartan Potassium during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. In patients who are intravascularly volume-depleted (e.g., those treated with high-dose diuretics), symptomatic hypotension may occur. Plasma concentration of Losartan Potassium is significantly increased in cirrhotic patients. Changes in renal function including renal failure have been reported in renal impaired patient.
",,,,,"keep in a dry place away from light and heat. Keep out of the reach of children.
",10
+2052,Lornoxicam,lornoxicam-2052,https://medex.com.bd/attachments/Sxide1HQijf8VPDdDfiKBrjqOjB7lE/lornoxicam-prescribing-information,Non-steroidal Anti-inflammatory Drugs (NSAIDs),Mild to moderate pain,"
+- Short-term relief of acute mild to moderate pain
+- Symptomatic relief of pain and inflammation in osteoarthritis
+- Symptomatic relief of pain and inflammation in rheumatoid arthritis.
+
","Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Lornoxicam is a non-steroidal anti-inflammatory drug (NSAID) that belongs to the oxicam class. As with other NSAIDS, lornoxicam is a potent inhibitor of the cyclooxgenase enzymes, which are responsible for catalyzing the formation of prostaglandins (act as messenger molecules in the process of inflammation) and thromboxane from arachidonic acid. Unlike some NSAIDS, lornoxicam's inhibition of cyclooxygenase does not lead to an increase in leukotriene formation, meaning that arachidonic acid is not moved to the 5-lipoxygenase cascade, resulting in the minimization of the risk of adverse events.
Like other NSAIDS, lornoxicam's anti-inflammatory and analgesic activity is related to its inhibitory action on prostaglandin and thromboxane synthesis through the inhibition of both COX-1 and COX-2. This leads to the reduction of inflammation, pain, fever, and swelling, which are mediated by prostaglandins. However, the exact mechanism of lornoxicam, like that of the other NSAIDs, has not been fully determined.
","For all patients, the appropriate dosing regimen should be based upon individual response to treatment.
Pain: 8-16 mg lornoxicam daily divided into 2 or 3 doses. The Maximum recommended daily dose is 16 mg.
Osteoarthritis and Rheumatoid arthritis: Initial recommended dose is 12 mg lornoxicam daily divided into 2 or 3 doses. The maintenance dose should not exceed 16 mg lornoxicam daily. Lornoxicam film-coated tablets are supplied for oral use and should be taken with a sufficient quantity of liquid.
Children and adolescents: Lornoxicam is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy.
Elderly: No special dosage modification is required for elderly patients above age 65, but Lornoxicam should be administered with precaution as gastrointestinal adverse effects are less well tolerated in this group.
Renal impairment: For patients with mild to moderate renal impairment the maximum recommended daily dose is 12 mg divided in 2 or 3 doses.
Hepatic impairment: For patients with moderate hepatic impairment the maximum recommended daily dose is 12 mg divided in 2 or 3 doses.
",,"
+- Cimetidine: Increased plasma concentrations of lornoxicam. (No interaction between lornoxicam and ranitidine, or lornoxicam and antacids has been demonstrated).
+- Anti-coagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin (see section 4.4). Careful monitoring of INR should be undertaken.
+- Phenprocoumon: Decreased effect of phenprocoumon treatment.
+- Heparin: NSAIDs increase the risk of spinal or epidural haematoma when given concomitantly to heparin in the context of spinal or epidural anaesthesia (see section 4.4).
+- ACE inhibitors: The antihypertensive effect of the ACE inhibitor may decrease.
+- Diuretics: Decreased diuretic and antihypertensive effect of loop diuretics, thiazide diuretics, and potassium sparing diuretics.
+- Beta-adrenergic blockers: Decreased antihypertensive efficacy.
+- Angiotensin II receptor blocker: Decreased antihypertensive efficacy.
+- Digoxin: Decreased renal clearance of digoxin.
+- Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
+- Quinolone antibiotics: Increased risk of seizures.
+- Anti-platelet agents: Increased risk of gastrointestinal bleeding (see section 4.4).
+- Other NSAIDs: Increased risk of gastrointestinal bleeding.
+- Methotrexate: Increased serum concentration of methotrexate. Increased toxicity may result. When concomitant therapy has to be used careful monitoring should be undertaken.
+- Selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding (see section 4.4).
+- Lithium: NSAIDs inhibit renal clearance of lithium, thus the serum concentration of lithium may increase above toxicity limits. Therefore serum lithium levels require monitoring, especially during initiation, adjustment and withdrawal of treatment.
+- Cyclosporine: Increased serum concentration of cyclosporine. Nephrotoxicity of cyclosporine may be enhanced via renal prostaglandin mediated effects. During combined treatment renal function should be monitored.
+- Sulphonylureas (e.g. glibenclamide): Increased risk of hypoglycaemia.
+- Known inducers and inhibitors of CYP2C9 isoenzymes: Lornoxicam (as other NSAIDs depending on the cytochrome P450 2C9 (CYP2C9 isoenzyme)) has interactions with known inducers and inhibitors of CYP2C9 isoenzymes (see section 5.2 Biotransformation).
+- Tacrolimus: Increase the risk of nephrotoxicity owing to reduced synthesis of prostacyclin in the kidney. During combined treatment renal function should be monitored (see section 4.4).
+- Pemetrexed: NSAIDs may reduce renal clearance of pemetrexed resulting in increased renal and gastrointestinal toxicity, and myelosuppression.
+
","
+- Hypersensitivity to lornoxicam or to any of the excipients
+- Thrombocytopenia
+- Hypersensitivity (symptoms like asthma, rhinitis, angioedema or urticaria) to other NSAIDs including acetylsalicylic acid
+- Severe heart failure.
+- Gastro-intestinal bleeding, cerebrovascular bleeding or other bleeding disorders
+- History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy
+- Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)
+- Severe hepatic impairment
+- Severe renal impairment (Serum creatinine > 700 µmol/l)
+- The third trimester of pregnancy
+
",,"Lornoxicam is contraindicated on the third trimester of pregnancy and should not be used during pregnancy in the first and second trimesters and delivery, as no clinical data on exposed pregnancies are available. There are no adequate data from the use of lornoxicam in pregnant women. Studies in animals have shown reproductive toxicity. There are no data on the excretion of lornoxicam in human breast milk. Lornoxicam is excreted in milk of lactating rats in relatively high concentrations. Therefore lornoxicam should not be used in breastfeeding women.
","Renal impairment: Lornoxicam should be administered with precaution in patients with mild (serum creatinine 150-300 µmol/l) to moderate (serum creatinine 300 – 700 µmol/l) renal impairment due to dependency on renal prostaglandins for maintenance of renal blood flow. Treatment with lornoxicam should be discontinued if renal function deteriorates during treatment. Renal functions should be monitored in patients who undergo major surgery, with cardiac failure, receiving treatment with diuretics, receiving concomitant treatment with drugs that are suspected to or known to be able to cause kidney damage.
Patients with blood coagulation disorders: Careful clinical monitoring and laboratory assessment is recommended (e.g. APTT).
Hepatic impairment (e.g. liver cirrhosis): Clinical monitoring and laboratory assessments at regular intervals should be considered in patients with hepatic impairment as accumulation of lornoxicam (increase in AUC) may occur after treatment with daily doses of 12-16 mg. Apart from that, hepatic impairment does not seem to affect pharmacokinetic parameters of lornoxicam as compared to healthy subjects.
Long term treatment (longer than 3 months): Regular laboratory assessments of haematology (haemoglobin), renal functions (creatinine) and liver enzymes are recommended.
Elderly patients above 65 years: Monitoring of renal and hepatic function is recommended. Precaution is advised in elderly postoperative patients.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+2067,Lorlatinib,lorlatinib-2067,https://medex.com.bd/attachments/U17933pSlbE080dTCJB8KcftvxiYmL/lorlatinib-prescribing-information,Cytotoxic Chemotherapy,Non-small cell lung cancer,"Lorlatinib as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after Alectinib or Ceritinib as the first ALK inhibitor therapy; or Crizotinib and at least one other ALK inhibitor.
","Cytotoxic Chemotherapy
","Lorlatinib is a kinase inhibitor with in vitro activity against ALK and ROS1 as well as TYK1, FER, FPS, TRKA, TRKB, TRKC, FAK, FAK2, and ACK. Lorlatinib demonstrated in vitro activity against multiple mutant forms of the ALK enzyme, including some mutations detected in tumors at the time of disease progression on crizotinib and other ALK inhibitors. in mice subcutaneously implanted with tumors harboring EML4 fusions with either ALK variant 1 or ALK mutations, including the G1202R and 11171T mutations detected in tumors at the time of disease progression on ALK inhibitors, administration of lorlatinib resulted in antitumor activity. Lorlatinib also demonstrated anti-tumor activity and prolonged survival in mice implanted intracranially with EML4-ALK-driven tumor cell lines. The overall antitumor activity of lorlatinib in in vivo models was dose-dependent and correlated with inhibition of ALK phosphorylation.
","The recommended dose is 100 mg Lorlatinib taken orally once daily. Treatment with Lorlatinib is recommended as long as the patient is deriving clinical benefit from therapy without unacceptable toxicity. If a dose of Lorlatinib is missed, then it should be taken as soon as the patient remembers unless it is less than 4 hours before the next dose, in which case the patient should not take the missed dose. Patients should not take 2 doses at the same time to make up for a missed dose.
Dosing interruption or dose reduction may be required based on individual safety and tolerability. Lorlatinib dose reduction levels are summarized below:
+
+- First dose reduction: 75 mg taken orally once daily.
+- Second dose reduction: 50 mg taken orally once daily.
+
+Lorlatinib should be permanently discontinued if the patient is unable to tolerate the 50 mg dose taken orally once daily.
",,"CYP3A4/5 substrates: In vitro studies indicated that Lorlatinib is a time-dependent inhibitor as well as an inducer of CYP3A4/5 and it activates the human pregnane-X-receptor (PXR), with the net effect in vivo being induction. Concurrent administration of Lorlatinib in patients resulted in decreased oral midazolam AUC when midazolam was administered alone, suggesting that Lorlatinib is an inducer of CYP3A4/5. Lorlatinib 150 mg orally once daily for 15 days decreased AUCinf and Cmax of a single oral 2 mg dose of midazolam (a sensitive CYP3A substrate) by 61% by 50%, respectively; hence, Lorlatinib is a moderate CYP3A inducer. Thus, concurrent administration of Lorlatinib with CYP3A4/5 substrates with narrow therapeutic indices, including but not limited to alfentanil, ciclosporin, dihydroergotamine, ergotamine, fentanyl, hormonal contraceptives, pimozide, quinidine, sirolimus and tacrolimus, should be avoided since the concentration of these medicinal products may be reduced by Lorlatinib.
In vitro studies of other CYP inhibition and induction: Lorlatinib may have the potential to inhibit CYP2C9. In vitro studies also indicated that Lorlatinib is an inducer of CYP2B6 and activates the human constitutive androstane receptor (CAR). Concomitant administration of Lorlatinib with CYP2B6 substrates (e.g. bupropion, efavirenz) may result in reduced plasma concentrations of the CYP2B6 substrate. In vitro, Lorlatinib has a low potential to cause drug-drug interactions by induction of CYP1A2.
In vitro studies of UGT inhibition: In vitro studies indicated that Lorlatinib may have the potential to inhibit UGT1A1.
In vitro studies with drug transporters: In vitro studies indicated that Lorlatinib may have the potential to inhibit P-glycoprotein (P-gp, systemically and at the gastrointestinal tract), BCRP (Gl tract), OATP1B1, OATP1B3, OCT1, MATE1 and OAT3 at clinically relevant concentrations.
","Hypersensitivity to Lorlatinib. Concomitant use of strong CYP3A4/5 inducers.
","The most frequently reported adverse reactions were hypercholesterolaemia (84.4%), hypertriglyceridaemia (67.1%), oedema (54.6%), peripheral neuropathy (47.8%), cognitive effects (28.8%), fatigue (28.1%), weight increased (26.4%) and mood effects (22.7%). Dose reductions due to adverse reactions occurred in 23.4% of patients receiving Lorlatinib. The most common adverse reactions that led to dose reductions were oedema and peripheral neuropathy. Permanent treatment discontinuation associated with adverse reactions occurred in 3.1% of patients receiving Lorlatinib. The most frequent adverse reaction that led to permanent discontinuations was cognitive effects.
","Women of childbearing potential/Contraception in males and females: Women of childbearing potential should be advised to avoid becoming pregnant while receiving Lorlatinib. A highly effective non-hormonal method of contraception is required for female patients during treatment with Lorlatinib, because Lorlatinib can render hormonal contraceptives ineffective. If a hormonal method of contraception is unavoidable, then a condom must be used in combination with the hormonal method. Effective contraception must be continued for at least 35 days after completing therapy. During treatment with Lorlatinib and for at least 14 weeks after the final dose, male patients with female partners of childbearing potential must use effective contraception, including a condom, and male patients with pregnant partners must use condoms.
Pregnancy: Studies in animals have shown embryo-fetal toxicity. There are no data from the use of Lorlatinib in pregnant women. Lorlatinib may cause fetal harm when administered to a pregnant woman. Lorlatinib is not recommended during pregnancy or for women of childbearing potential not using contraception.
Breast-feeding: It is unknown whether Lorlatinib and its metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Lorlatinib should not be used during breastfeeding. Breast-feeding should be discontinued during treatment with Lorlatinib and for 7 days after the final dose.
Fertility: Based on non-clinical safety findings, male fertility may be compromised during treatment with Lorlatinib. It is not known whether Lorlatinib affects female fertility. Men should seek advice on effective fertility preservation before treatment.
","Hyperlipidaemia: The use of Lorlatinib has been associated with increases in serum cholesterol and triglycerides. Median time of occurrence of severe increase in serum cholesterol and triglycerides is 201 days (range: 42 to 518 days) and 127 days (range: 15 to 358 days), respectively. Serum cholesterol and triglycerides should be monitored before initiation of Lorlatinib; 2, 4 and 8 weeks after initiating Lorlatinib; and regularly thereafter. Initiate or increase the dose of lipid-lowering medicinal products, if indicated.
Central nervous system effects: Central nervous system (CNS) effects have been observed in patients receiving Lorlatinib, including changes in cognitive function, mood or speech. Dose modification or discontinuation may be required for those patients who develop CNS effects.
Atrioventricular block: Lorlatinib was studied in a population of patients that excluded those with second degree or third-degree AV block (unless paced) or any AV block with PR interval > 220 msec. PR interval prolongation and AV block have been reported in patients receiving Lorlatinib. Monitor electrocardiogram (ECG) prior to initiating Lorlatinib and monthly thereafter, particularly in patients with predisposing conditions to the occurrence of clinically significant cardiac events. Dose modification may be required for those patients who develop AV block.
Left ventricular ejection fraction decrease: Left ventricular ejection fraction (LVEF) decrease has been reported in patients receiving Lorlatinib who had baseline and at least one follow-up LVEF assessment. Based on the available clinical study data, it is not possible to determine a causal relationship between effects on changes in cardiac contractility and Lorlatinib. In patients with cardiac risk factors and those with conditions that can affect LVEF, cardiac monitoring, including LVEF assessment at baseline and during treatment, should be considered. In patients who develop relevant cardiac signs/symptoms during treatment, cardiac monitoring, including LVEF assessment, should be considered.
Lipase and amylase increase: Elevations of lipase and/or amylase have occurred in patients receiving Lorlatinib. Median time of occurrence of increase in serum lipase and amylase is 70 days (range: 7 to 696 days) and 41 days (range: 7 to 489 days), respectively. Risk of pancreatitis should be considered in patients receiving Lorlatinib due to concomitant hypertriglyceridemia and/or a potential intrinsic mechanism. Patients should be monitored for lipase and amylase elevations prior to the start of Lorlatinib treatment and regularly thereafter as clinically indicated.
Interstitial lung disease/Pneumonitis: Severe or life-threatening pulmonary adverse reactions consistent with ILD/pneumonitis have occurred with Lorlatinib. Any patient who presents with worsening of respiratory symptoms indicative of ILD/pneumonitis (e.g. dyspnoea, cough and fever) should be promptly evaluated for ILD/pneumonitis. Lorlatinib should be withheld and/or permanently discontinued based on severity.
Drug-drug interactions: In a study conducted in healthy volunteers, the concomitant use of Lorlatinib and rifampin, a strong CYP3A4/5 inducer, was associated with increases of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) with no increase of total bilirubin and alkaline phosphatase. Concomitant use of a strong CYP3A4/5 inducer is contraindicated. Concomitant use with moderate CYP3A4/5 inducers should be avoided, if possible, as they may also reduce Lorlatinib plasma concentrations. Concurrent administration of Lorlatinib with CYP3A4/5 substrates with narrow therapeutic indices, including but not limited to alfentanil, ciclosporin, dihydroergotamine, ergotamine, fentanyl, hormonal contraceptives, pimozide, quinidine, sirolimus and tacrolimus, should be avoided since the concentration of these medicinal products may be reduced by Lorlatinib.
Fertility and pregnancy: During treatment with Lorlatinib and for at least 14 weeks after the final dose, male patients with female partners of childbearing potential must use effective contraception, including a condom, and male patients with pregnant partners must use condoms. Male fertility may be compromised during treatment with Lorlatinib. Men should seek advice on effective fertility preservation before treatment. Women of childbearing potential should be advised to avoid becoming pregnant while receiving Lorlatinib. A highly effective non-hormonal method of contraception is required for female patients during treatment with Lorlatinib, because Lorlatinib can render hormonal contraceptives ineffective. If a hormonal method of contraception is unavoidable, then a condom must be used in combination with the hormonal method. Effective contraception must be continued for at least 35 days after completing therapy . It is not known whether Lorlatinib affects female fertility.
Dietary sodium: This medicinal product contains less than 1 mmol sodium (23 mg) per 25 mg or 100 mg tablet. Patients on low sodium diets should be informed that this product is essentially ""sodium-free"".
Pharmacokinetic interactions: In vitro data indicate that Lorlatinib is primarily metabolized by CYP3A4 and uridine diphosphate-glucuronosyltransferase (UGT)1A4, with minor contributions from CYP2C8, CYP2C19, CYP3A5 and UGT1A3.
CYP3A4/5 inducers: Rifampin, a strong inducer of CYP3A4/5, administered at oral doses of 600 mg once daily for 12 days, reduced the mean Lorlatinib area under curve (AUC) by 85% and Cmax by 76% of a single 100 mg oral dose of Lorlatinib in healthy volunteers; increases in AST and ALT were also observed. Concomitant administration of Lorlatinib with strong CYP3A4/5 inducers (e.g. rifampicin, carbamazepine, enzalutamide, mitotane, phenytoin and St. John's wort) may decrease Lorlatinib plasma concentrations. The use of a strong CYP3A4/5 inducer with Lorlatinib is contraindicated. Concomitant use with moderate CYP3A4/5 inducers should be avoided, if possible, as they may also reduce Lorlatinib plasma concentrations.
CYP3A4/5 inhibitors: Itraconazole, a strong inhibitor of CYP3A4/5, administered at oral doses of 200 mg once daily for 5 days, increased the mean Lorlatinib AUC by 42% and Cmax by 24% of a single 100 mg oral dose of Lorlatinib in healthy volunteers. Concomitant administration of Lorlatinib with strong CYP3A4/5 inhibitors (e.g. boceprevir, cobicistat, itraconazole, ketoconazole, posaconazole, troleandomycin, voriconazole, ritonavir, paritaprevir in combination with ritonavir and ombitasvir and/or dasabuvir, and ritonavir in combination with either elvitegravir, indinavir, lopinavir or tipranavir) may increase Lorlatinib plasma concentrations. Grapefruit products may also increase Lorlatinib plasma concentrations and should be avoided. An alternative concomitant medicinal product with less potential to inhibit CYP3A4/5 should be considered. If a strong CYP3A4/5 inhibitor must be concomitantly administered, a dose reduction of Lorlatinib is recommended.
","Elderly (≥65 years): Due to limited data on this population, no dose recommendation can be made for patients aged 65 years and older.
Renal impairment: No dose adjustment is needed for patients with normal renal function and mild or moderate (ClCr: >30mL/min) renal impairment based on a population pharmacokinetic analysis. Information for Lorlatinib use in patients with severe (ClCr: <30 mL/min) renal impairment is very limited. Therefore, Lorlatinib is not recommended in patients with severe renal impairment.
Hepatic impairment: No dose adjustments is recommended for patients with mild hepatic impairment. No information is available for Lorlatinib in patients with moderate or severe hepatic impairment. Therefore, Lorlatinib is not recommended in patients with moderate to severe hepatic impairment.
Pediatric population: The safety and efficacy of Lorlatinib in pediatric patients below 18 years have not been established. No data are available.
","Treatment of overdose with the medicinal product consists of general supportive measures. Given the dose-dependent effect on PR interval, ECG monitoring is recommended. There is no antidote for Lorlatinib.
",,,"Store below 30°C. Protect from moisture and light. Keep Lorlatinib out of the sight and reach of children.
",12
+698,Lorazepam,lorazepam-698,https://medex.com.bd/attachments/A71ghRkN0GZ5arWQdPq5UqVuXXOSZ3/lorazepam-tablets-prescribing-information,Benzodiazepine hypnotics,,"Lorazepam is used for the treatment of anxiety states; including anxiety associated with phobic & obsessional states, psychosomatic, organic or psychotic illness, insomnia associated with anxiety, nervousness, restlessness, nausea and vomiting related to chemotherapy and anticonvulsants, and as ... Read more
Lorazepam is used for the treatment of anxiety states; including anxiety associated with phobic & obsessional states, psychosomatic, organic or psychotic illness, insomnia associated with anxiety, nervousness, restlessness, nausea and vomiting related to chemotherapy and anticonvulsants, and as a premedicant before dental or general surgery or prior to investigative procedures where there may be discomfort. Lorazepam is not recommended in anxiety states in children but may be used as premedicant before surgery at a dose of 0.05 mg/Kg in children aged 5 to 13 years. The dosage of Lorazepam tablet should be increased gradually when needed to avoid adverse effects. When higher dosage is indicated, the evening dose should be increased before the daytime.
","Benzodiazepine hypnotics, Benzodiazepine sedatives
","Lorazepam is a short-acting tranquilizer of the benzodiazepine group. It is an agonist at benzodiazepine receptors in the CNS. It exerts a depressant action on the CNS, which may be mediated by potentiating the inhibitory actions of GABA (gamma amino butyric acid) in the CNS. This will result in diminution of the ascending activating systems, particularly the serotonergic and noradrenergic pathway from brain stem or the mid-brain to the cerebral cortex.
","Lorazepam is administered orally. For optimal results; dose, frequency of administration and duration of therapy should be individualized according to patient's response.
+
+- The usual range is 2 to 6 mg/day given in divided doses, the largest dose being taken before bedtime, but the largest dosage may vary from 1 to 10 mg/day.
+- For anxiety, most patients require an initial dose of 2 to 3 mg/day given b.i.d. or t.i.d.
+- For elderly or debilitated patients, an initial dosage of 1 to 2 mg/day in divided doses is recommended, to be adjusted as needed and tolerated.
+- For insomnia 1 to 2 mg before bedtime and as premedicant 1 to 2 mg the night before surgery and 1 to 2 hour before surgery.
+
+Lorazepam injection can be given intravenously or intramuscularly. Premedication (Adults): 0.05 mg/kg (3.5 mg for average 70 kg person) (For IV 30-45 minutes before & IM 60-90 minutes before); Acute anxiety (Adults): 0.025-0.03 mg/kg (1.75-2.1 mg for an average 70 kg person), Repeat 6 hourly; Status epilepticus (Adults): 4 mg intravenously; Status epilepticus (Children): 2 mg intravenously.
For IM use, undiluted Lorazepam injection should be administered. For IV use, it must be diluted with an equal volume of compatible solutions e.g. Sterile Water for Injection, Sodium Chloride Injection, 5% Dextrose Injection. The rate of injection should not exceed 2 mg per minute.
",,"Lorazepam may potentiate the central depressant effect when combined with other drugs with central depressant action. Such drugs include alcohol, general anesthetics, tricyclic antidepressants and monoamine oxidase inhibitors.
","Lorazepam should not be given to patients with a previous sensitivity to benzodiazepines or with acute narrow-angle glaucoma and myasthenia gravis.
","Adverse reactions are usually observed at the beginning of therapy and generally disappeared on continued medication or upon decreasing the dose. The most frequent adverse reactions of Lorazepam are sedation followed by dizziness, weakness and unsteadiness. Less frequent adverse reactions are disorientation, depression, nausea, change in appetite, headache, sleep disturbance, agitation, dermatological symptoms, eye-function disturbance, together with various gastrointestinal symptoms and autonomic manifestations.
","Safety of Lorazepam in pregnancy has not been established. Because the use of this drug is rarely a matter of urgency, the use of Lorazepam during this period should almost always be avoided.
It is not known whether oral Lorazepam is excreted in human milk like other benzodiazepine tranquilizers. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.
","In patients with depression accompanying anxiety, a possibility for suicide should be borne in mind. For elderly or debilitated patients, the initial daily dosage should not exceed 2 mg in order to avoid over sedation. The usual precautions for treating patients with impaired renal or hepatic function and with acute and chronic pulmonary insufficiency should be observed. Use of Lorazepam for prolonged period and gastric patients requires caution and there should be frequent monitoring for symptoms of upper gastrointestinal disease. Machineries should be avoided during taking Lorazepam.
",,"Overdosage of Lorazepam is usually manifested by varying degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion and lethargy. In more serious cases and especially when other drugs or alcohol were ingested, symptoms may include ataxia, hypotonia, hypotension, hypnotic states (stages I to III), coma.
",,,"Store between 20-25°C
",11
+697,Loratadine + Pseudoephedrine,loratadine-pseudoephedrine-697,https://medex.com.bd/attachments/FhV0SGadIRbymbM6bGKwe96hZBdGW3/loratadine-pseudoephedrine-prescribing-information,Anti-histamine & decongestant,Sneezing,"This tablet should be administered when both the antihistaminic properties of Loratadine and the nasal decongestant activity of Pseudoephedrine are desired. This is indicated for the relief of the following symptoms due to hay fever or other upper respiratory allergies:
+
+- nasal congestion
+- runny nose
... Read more
This tablet should be administered when both the antihistaminic properties of Loratadine and the nasal decongestant activity of Pseudoephedrine are desired. This is indicated for the relief of the following symptoms due to hay fever or other upper respiratory allergies:
+
+- nasal congestion
+- runny nose
+- sneezing
+- itchy, watery eyes
+- itching of the nose or throat
+- swelling of nasal passages
+- sinus congestion and pressure
+
","Anti-histamine & decongestant
","Loratadine is a non-sedative histamine H1-receptor antagonist with anti-allergic properties. Loratadine is a long acting tricyclic anti-histamine with selective peripheral H1-receptor antagonistic activity and no central sedative or anti-cholinergic effect.
Pseudoephedrine is an orally active sympathomimetic amine and exerts a decongestant action on the nasal mucosa. This is recognized as an effective agent for the relief of nasal congestion due to allergic rhinitis. It has nasal and bronchial decongestant activity. Pseudoephedrine is both an α-and β-adrenergic receptor agonist. It causes vasoconstriction via direct stimulation of α-adrenergic receptors of the respiratory mucosa. It also directly stimulates β-adrenergic receptors causing bronchial relaxation, increased heart rate and contractility.
","Adults and children over 12 years:
+
+- 5/120 tablet: One tablet twice daily (every 12 hours)
+- 10/240 tablet: One tablet once daily and to be taken in the morning instead of night.
+
+Patients with renal insufficiency (GFR<30 ml/min) should be given a lower initial dose (one 5/120 tablet per day, or one 10/240 tablet every alternate day) because they have reduced clearance of Loratadine and Pseudoephedrine.
Patients who have a history of difficulty in swallowing tablets or who have known upper gastrointestinal narrowing or abnormal esophageal peristalsis should not use 10/240 tablet.
Paediatric use: Safety and effectiveness in children below the age of 12 years have not been established.
Use in patients approximately 60 years of age and older: The safety and efficacy of this tablet in patients greater than 60 years old have not been investigated in placebo-controlled clinical trials. The elderly is more likely to have adverse reactions to sympathomimetic amines.
","Loratadine & Pseudoephedrine tablet should be administered when both the antihistaminic properties of Loratadine and the nasal decongestant activity of Pseudoephedrine Sulfate are desired in patients 12 years of age and older.
","This tablet is contraindicated in patients taking monoamino oxidase (MAO) inhibitors and for 2 weeks after stopping use of an MAO inhibitor. The antihypertensive effects of beta-adrenergic blocking agents, methyldopa, reserpine and veaturm alkaloids may be reduced by sympathomimetics. Increased ectopic pacemaker activity can occur when Pseudoephedrine is used concomitantly with digitalis. Concomitantly administration of Erythromycin, Ketoconazole and Cimetidine increases plasma concentration of both Loratadine and Decarboethoxyloratadine. But there were no clinically relevant changes in the safety profile of Loratadine.
","This tablet is contraindicated in patients who are hypersensitive to any component of this product.
","In general it is well tolerated. Clinical trial suggests a very low of adverse effects commonly reported is dry mouth, somnolence, insomnia, pharyngitis, dizziness, coughing, fatigue, nausea, nervousness, anorexia, dysmenorrheal and headache. Other less common side effects may include; increased sweating, thirst, back pain, chest pain, malaise, palpitations, hypertension, tachycardia, abdominal distension, altered taste, flatulence, myalgia, dry throat, agitation, micturation frequency etc.
","Pregnancy category B: no evidence of risk in human is reported. It is not known if this combination product is excreted in human milk. However, both Loratadine and Pseudoephedrine when administered alone passed into breast milk, so it should not be administered to lactating mothers.
","This tablet should generally be avoided in patients with hepatic insufficiency. Patients with renal insufficiency should be given a lower initial dose because they have reduced clearance of Loratadine and Pseudoephedrine. As because the doses of this fixed combination product cannot be individually titrated and hepatic insufficiency results in a reduced clearance of Loratadine to a much greater extent than Pseudoephedrine.
This tablet should be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or with accompanying hypotension may be produced by sympathomimetic amines.
",,"In the event of overdosage, general symptomatic and supportive measure should be instituted promptly and maintained for as long as necessary. Treatment of overdose would reasonably consist of emesis (ipecac syrup), except in patients with impaired consciousness, followed by the administration of activated charcoal to absorb any remaining drug. If vomiting is unsuccessful or contraindicated, gastric lavage should be performed with normal saline.
",,,"Store at a cool and dry place, away from light. Keep out of the reach of children.
",12
+696,Loratadine,loratadine-696,https://medex.com.bd/attachments/RuU7isGmUOJXDREpsnKHEWkNBvy6d4/loratadine-prescribing-information,Non-sedating antihistamines,Urticaria,"Loratadine tablet provides fast, effective relief from the symptoms of seasonal allergic rhinitis, perennial allergic rhinitis and skin allergies including chronic urticaria. It is also effective in alleviating symptoms of allergic rhinitis such as sneezing, nasal discharge, itching, ocular itching ... Read more
Loratadine tablet provides fast, effective relief from the symptoms of seasonal allergic rhinitis, perennial allergic rhinitis and skin allergies including chronic urticaria. It is also effective in alleviating symptoms of allergic rhinitis such as sneezing, nasal discharge, itching, ocular itching and burning. Nasal and ocular sign and symptoms are relieved rapidly after oral administration. Loratadine tablet is also indicated in idiopathic urticaria. In children over 2 years Loratadine tablet is indicated for the symptomatic relief of seasonal allergic rhinitis and allergic skin conditions such as urticaria, nettlerash.
","Non-sedating antihistamines
","This tablet is a preparation of Loratadine. Loratadine is a non-sedative histamine Hr receptor antagonist with antiallergic properties. Loratadine is a long-acting tricyclic antihistamine with selective peripheral Hi-receptor antagonistic activity and no central sedative or anticholinergic effect. It is rapidly effective and long-lasting, allowing once-a-day administration.
","Adults and children over 12 years of age: One Loratadine tablet once daily. It is usually administered in the morning or when symptoms require treatment.
Children 2-12 years: Body weight over 30 kg: one Loratadine tablet once daily, below 30 kg: half Loratadine tablet once daily.
Below 2 years of age: Loratadine tablet is not recommended for use below 2 years of age since safety and efficacy has not been established.
",,"There are no reports of potentially hazardous interactions with other drugs. In contrast to many other histamine H1 receptor antagonists, Loratadine has no potentiating effects when administered concurrently with alcohol, as measured by psychomotor performance studies. Concomitant therapy with drugs that inhibit or are metabolized by hepatic cytochromes P450 3A4 and 2D6 may elevate plasma concentrations of either drug and this mayifesult in adverse effects. Cimetidine inhibits both enzymes while erythromycin or ketoconazole inhibits P450 3A4. These drugs increase loratadine serum concentrations but no adverse effects are reported.
","Loratadine is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to their components.
","During controlled clinical studies the incidence of adverse events, including sedation and anticholinergic effects observed with 10 mg Loratadine was comparable to that observed with placebo. Studies on the effect of Loratadine on actual driving performance, and on tests of cognitive and psychomotor functioning have shown it to be comparable to placebo.
","There is no experience of the use of Loratadine in human pregnancy. Therefore its use during pregnancy is not advisable. Loratadine is excreted in breast milk in a very small amount. So nursing mothers are advised not to take the drug.
","Caution should be taken in patients with liver impairment or renal insufficiency (eGFR <30 ml/min).
",,"In adults somnolence, tachycardia and headache have been reported with overdose greater than 10 mg. Extrapyramidal signs and palpitations have been reported in children with overdoses of greater than 10 mg. In the event of overdosage, general symptomatic and supportive measures should be instituted promptly and maintained for as long as necessary. It would seem reasonable to treat patients presenting early after large overdoses with oral activated charcoal. The conscious patients may be induced to vomit or gastric lavage may be performed.
",,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",11
+1569,Lopinavir + Ritonavir,lopinavir-ritonavir-1569,https://medex.com.bd/attachments/oc7JrZM91zBPSoLcvNvwlbpuyOdlBA/lopinavir-ritonavir-prescribing-information,Drugs for HIV / Anti-retroviral drugs,HIV infection,"Lopinavir and Ritonavir is an HIV-1 protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients (14 days and older).
","Drugs for HIV / Anti-retroviral drugs
",,"Lopinavir and Ritonavir tablets may be taken with or without food, swallowed whole and not chewed, broken, or crushed.
Adult Patients:
+
+- 400/100 mg (two 200/50 mg tablets) twice daily, or
+- 800/200 mg (four 200/50 mg tablets) once daily in patients with less than three lopinavir resistance-associated substitutions.
+
+
Concomitant Therapy in Adults Patients: Dose adjustments of Lopinavir and Ritonavir may be needed when co-administering with efavirenz, nevirapine, or nelfinavir.
Do not use once daily administration of Lopinavir and Ritonavir in: HIV-1 infected patients with three or more of the following lopinavir resistance-associated substitutions: L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V. Combination with efavirenz, nevirapine, nelfinavir, carbamazepine, phenobarbital, or phenytoin.
",,"Co-administration of Lopinavir and Ritonavir is contraindicated with potent CYP3A inducers where significantly reduced lopinavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance and cross resistance. It is also contraindicated with Alpha 1 Adrenoreceptor Antagonist (Alfuzosin), Antimycobacterial (Rifampin), Ergot Derivatives ( Dihydroergotamine, ergotamine, methylergonovine), Gl Motility Agent (Cisapride), HMG-CoA Reductase Inhibitors (Lovastatin, simvastatin), PDE5 Enzyme Inhibitor (Sildenafil, when used for the treatment of pulmonary arterial hypertension), Neuroleptic (Pimozide) Sedative/Hypnotics (Triazolam; orally administered midazolam)
","Lopinavir and Ritonavir is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, urticaria, angioedema) to any of its ingredients, including lopinavir and ritonavir.
Co-administration of Lopinavir and Ritonavir is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions.
","Commonly reported side effects included diarrhea, nausea, vomiting, hypertriglyceridemia and hypercholesterolemia.
","Nursing Mothers: The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1. Studies in rats have demonstrated that lopinavir is secreted in milk. It is not known whether lopinavir is secreted in human milk. Because of both the potential for HIV-1 transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving this combination
","The following have been observed in patients receiving Lopinavir and Ritonavir:
Hepatotoxicity: Patients with underlying hepatitis B or C or marked elevations in transaminase prior to treatment may be at increased risk for developing or worsening of transaminase elevations or hepatic decompensation with use of this combination.
QT Interval Prolongation: In cases of QT interval prolongation and torsade de pointes have been reported although causality of this combination could not be established. Avoid use in patients with congenital long QT syndrome, those with hypokalemia, and with other drugs that prolong the QT interval.
PR Interval Prolongation: Lopinavir/ritonavir prolongs the PR interval in some patients. Cases of second or third degree atrioventricular block have been reported. This combination should be used with caution in patients with underlying structural heart disease, pre-existing conduction system abnormalities, ischemic heart disease or cardiomyopathies, as these patients may be at increased risk for developing cardiac conduction abnormalities.
Diabetes Mellitus/Hyperglycemia: New onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, and hyperglycemia have been reported in HIV-1 infected patients receiving protease inhibitor therapy. Some patients required either initiation or dose adjustments of insulin or oral hypoglycemic agents for treatment of these events. In some cases, diabetic ketoacidosis has occurred. In those patients who discontinued protease inhibitor therapy, hyperglycemia persisted in some cases.
Lipid Elevations: Treatment with Lopinavir and Ritonavir has resulted in large increases in the concentration of total cholesterol and triglycerides.
","Pediatric Use: The safety, efficacy, and pharmacokinetic profiles of this combination in pediatric patients below the age of 14 days have not been established.
","Human experience of acute overdosage with this combination is limited. Treatment of overdose should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. There is no specific antidote for overdose with this combination. If indicated, elimination of unabsorbed drug should be achieved by gastric lavage. Administration of activated charcoal may also be used to aid in removal of unabsorbed drug. Since lopinavir is highly protein bound, dialysis is unlikely to be beneficial in significant removal of the drug. However, dialysis can remove both alcohol and propylene glycol in the case of overdose with this combination.
",,,"Keep in a dry place & store below 30° C. Protect from light & keep out of the reach of children.
",11
+695,Loperamide Hydrochloride,loperamide-hydrochloride-695,https://medex.com.bd/attachments/Yg9OXIg0SjkdJQ1l1MNbNRZfYIc9PJ/loperamide-hydrochloride-prescribing-information,Anti-diarrhoeal,Ulcerative colitis,"Loperamide Hydrochloride is indicated in-
+
+- Acute diarrhea
+- Chronic diarrhea
+- Abdominal cramps associated with diarrhea
+- Crohn's disease
+- Postgastric surgery
+- Ulcerative colitis.
+
","Anti-diarrhoeal, Anti-motility drugs
","Loperamide Hydrochloride inhibits the peristaltic activity of the longitudinal and circular smooth muscle in the intestine by interacting with cholinergic and noncholinergic neuronal mechanisms responsible for producing the peristaltic reflex. Loperamide Hydrochloride binds to the opiate receptor in the gut wall, reducing propulsive peristalsis and increasing intestinal transit time. Loperamide Hydrochloride increases the tone of the anal sphincter. This also inhibits electrolyte and fluid secretion in the intestine.
Loperamide Hydrochloride is an orally administered capsule. After administration absorption is more than 65% which occurs at a modest rate, with peak serum levels of 2-3 µgm/litre occurring at about 4 hours later after oral administration. The rest 35% is excreted unchanged in the faeces. Loperamide Hydrochloride undergoes an extensive presystemic first-pass metabolism in the gut wall and in the liver. Loperamide does not act centrally due to its high affinity for the gut wall and its presystemic metabolism. This is why it reaches the systemic circulation in a very minute amount. The route of elimination is 0.63-1.4% in urine as an unchanged drug, 58% is excreted in the bile and 15-23% appears in the faeces.
","Acute diarrhea-
+
+- Adults: 2 capsules initially followed by 1 capsule after every loose stool.
+- Usual dosage: 3-4 capsules/day. The maximum daily dose should not exceed 8 capsules.
+- Children (9-12 years): 1 capsule after each loose stool until diarrhea is controlled. But not more than 6 capsules daily.
+- Children (5-9 years): 1 capsule 4 times daily until diarrhea is controlled. But not more than 4 capsules daily.
+
+Chronic diarrhea-
+
+- Adults: 2-4 capsules daily in divided doses, depending on severity.
+- Children: 1-2 capsules daily, depending on severity. Or directed by physician.
+
",,"There are no data available.
","Hypersensitivity to the drug and in patients who must avoid constipation. Loperamide Hydrochloride should not be used alone in acute dysentery, which is characterized by blood in the stool and elevated body temperature.
","Abdominal pain and other gastrointestinal disturbances including dry mouth, dizziness, fatigue and skin rashes etc. have been reported.
","Safety in human pregnancy has not been established. As with other drugs, it is not advisable to administer Loperamide in pregnancy. Although the fraction of Loperamide Hydrochloride secreted in human breast milk is extremely low, caution is advised if Loperamide Hydrochloride is to be administered to a nursing mother.
","Loperamide Hydrochloride must be used with caution in cases of severe hepatic disturbance.
",,"Overdosage of Loperamide may result in constipation, CNS depression, and nausea.
",,,"Keep all medicines out of reach of children. Store in a cool and dry place protected from light.
",11
+1320,Lomefloxacin (Oral),lomefloxacin-oral-1320,https://medex.com.bd/attachments/hfrccyogMXMhO6Zz0TwRWRsBbxFfsk/lomefloxacin-oral-prescribing-information,Aural Anti-bacterial preparations,Urinary tract infection,"Lomefloxacin oral preparation is indicated for the treatment of:
+
+- Uncomplicated urinary tract infections.
+- Complicated including recurrent and pyelonephritis, urinary tract infections.
+- Acute exacerbation of chronic bronchitis.
+- Skin and skin structure infections.
... Read more
Lomefloxacin oral preparation is indicated for the treatment of:
+
+- Uncomplicated urinary tract infections.
+- Complicated including recurrent and pyelonephritis, urinary tract infections.
+- Acute exacerbation of chronic bronchitis.
+- Skin and skin structure infections.
+
+Prevention/Prophylaxis: Lomefloxacin is indicated preperatively to prevent postoperative urinary tract infections in patients undergoing transurethral surgical procedures.
","4-Quinolone preparations, Aural Anti-bacterial preparations
","Lomefloxacin, a difluorinated quinolone derivative, is a bacterial gyrase inhibitor, effective against gram positive and gram negative bacteria. The acute toxicity of Lomefloxacin following systemic and topical ophthalmic application is low. Lomefloxacin interferes with bacterial DNA related processes like initiation, elongation, and termination phases of replication, transcription, DNA repairing, recombination, transposition, supercoiling and relaxation of DNA. The target molecule for quinolones is the A-subunit of bacterial enzyme gyrase (topoisomerase II). The forming of a stable complex between the quinolone and the whole gyrase teramer A2B2 leads to impaired enzyme functions, resulting in a rapid killing of sensitive bacteria.
Cross-resistance has only been reported with other quinolones, but not with any other group of antibiotics. No clinical studies are available about the efficacy in cases of infections with chlamydia.
","Typhoid fever: 400 mg once daily or 200 mg b.i.d 10-14 days.
UTI infections:
+
+- Uncomplicated: 400 mg once daily or 200 mg b.i.d 3 days.
+- Complicated: 400 mg once daily or 200 mg b.i.d 10-14 days.
+
+Bacterial Diarrhea: 400 mg once daily or 200 mg b.i.d 5-7 days.
Acute exacerbation of chronic bronchitis: 400 mg once daily 7-10 days.
Skin and skin structure infections: 400 mg once daily 10-14 days.
Prophylaxis of UTI following surgery: 400 mg Single dose 2-6 hours prior to transurethral surgery.
",,"Lomefloxacin does not alter theophylline clearance and concentration. No change of caffeine is reported. Sucralfate and antacid containing magnesium and aluminium interfere with its bioavailability. Enhances effects of warfarin. Probenecid slows renal elimination of Lomefloxacin.
","Lomefloxacin is contraindicated in patients with a history of hypersensitivity to Lomefloxacin or to other quinolones. Lomefloxacin like other drugs in its class, cause arthropathy in juvenile animals. Therefore, its use in children, growing adolescents, and pregnant women is not recommended.
","Common side effects are Nausea, headache, photosensitivity, dizziness, diarrhea, dry mouth, fatigue, convulsions, CNS stimulation which may lead to tremors, restlessness, light headedness, confusion & hallucinations and pseudomembranous colitis.
","Pregnancy Category C. Reproductive function studies have been performed in rats at doses up to 8 times the recommended human dose based on mg/m² (34 times the recommended human dose based on mg/kg), and no impaired fertility or harm to the fetus was reported due to lomefloxacin. Increased incidence of fetal loss in monkeys has been observed at approximately 3 to 6 times the recommended human dose based on mg/m² (6 to 12 times the recommended human dose based on mg/kg). No teratogenicity has been observed in rats and monkeys at up to 16 times the recommended human dose exposure. In the rabbit, maternal toxicity and associated fetotoxicity, decreased placental weight, and variations of the coccygeal vertebrae occurred at doses 2 times the recommended human exposure based on mg/m². There are, however, no adequate and well-controlled studies in pregnant women. Lomefloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing mothers: It is not known whether lomefloxacin is excreted in human milk. However, it is known that other drugs of this class are excreted in human milk and that lomefloxacin is excreted in the milk of lactating rats. Because of the potential for serious adverse reactions from lomefloxacin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","Alterations of the dosage regimen is recommended for patients with impairment of renal function (CrCl <40 ml/min/1.73 m2). Avoid exposure to excessive sunlight or artificial UV light. Phototoxicity reaction may occur if undue exposure occurs. Safety and efficacy of Lomefloxacin has not been established in children, pregnant and lactating women.
","Pediatric use: The safety and effectiveness of lomefloxacin in pediatric patients and adolescents less than 18 years of age have not been established. Lomefloxacin causes arthropathy in juvenile animals of several species.
Geriatric use: Of the total number of subjects in clinical studies of lomefloxacin, 25% were ≥65 years and 9% were ≥ 75 years. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
",,,,"Should be stored in cool and dry place
",11
+693,Lomefloxacin (Ophthalmic),lomefloxacin-ophthalmic-693,,Ophthalmic antibacterial drugs,Otic infections,"Lomefloxacin ophthalmic preparation is indicated in the bacterial infections, including conjunctivitis, blepharitis, blepharoconjunctivitis which are due to Lomefloxacin susceptible germs and Staphylococcus aureus- induced corneal ulcers.
","4-Quinolone preparations, Ophthalmic antibacterial drugs
","Lomefloxacin, a difluorinated quinolone derivative, is a bacterial gyrase inhibitor, effective against gram positive and gram negative bacteria. The acute toxicity of Lomefloxacin following systemic and topical ophthalmic application is low. Lomefloxacin interferes with bacterial DNA related processes like initiation, elongation, and termination phases of replication, transcription, DNA repairing, recombination, transposition, supercoiling and relaxation of DNA. The target molecule for quinolones is the A-subunit of bacterial enzyme gyrase (topoisomerase II). The forming of a stable complex between the quinolone and the whole gyrase teramer A2B2 leads to impaired enzyme functions, resulting in a rapid killing of sensitive bacteria.
Cross-resistance has only been reported with other quinolones, but not with any other group of antibiotics. No clinical studies are available about the efficacy in cases of infections with chlamydia.
","Adults and children (above 1 year of age): Instill 2-3 times daily 1 drop into the lower conjunctival sac. At the beginning of the treatment application should be more frequent, apply 5 drops within 20 minutes or 1 drop every hour during 6-10 hours. Duration of the treatment: 7 to 9 days.
","May be taken with or without food.
","In order to avoid reduction of efficacy, no ophthalmic preparations containing heavy metals, such as zinc, should be used during 15 minutes preceding and following application of Lomefloxacin. Bacteriostatic ophthalmic antibiotics should not be used concomitantly with Lomefloxacin eye drops.
","Hypersensitivity to the active ingredient, to excipients, or to quinolones. Long term treatment with antibiotics may enhance development of secondary fungal infections or may support growth of non susceptible bacteria.
","Slight and transient burning immediately after instillation of the eye drops has been reported in 4.7% of users. Although phototoxicity has not been reported after ophthalmic use, photosensitization is possible. Since the following allergic reactions have been reported after systemic use of Lomefloxacin, they can not be excluded after topical ophthalmic use: allergic reactions, asthma, dyspnoea, urticaria, erythema, pruritus, and hypersensitization.
","Animal studies revealed that after systemic use of 20 mg/kg, Lomefloxacin passes the placenta barrier and is excreted into the maternal milk. Clinical studies on the use of Lomefloxacin eye drops during human pregnancy or lactation are not available. Therefore, the drug should only be used when the benefit outweighs the potential risk for the foetus or the infant.
","Some isolated cases of phototoxicity have been reported after systemic but not after topical ophthalmic use of Lomefloxacin. Nevertheless, during treatment with Lomefloxacin intensive exposure to sunlight or UV-radiation should be avoided
",,"Practically there is no risk of adverse effects due to accidental oral ingestion, since a bottle of 5 ml eye drop solution contains only 15 mg Lomefloxacin. This corresponds to 3.75% of the recommended oral daily dose for adults of 400 mg Lomefloxacin.
",,,"Store at 15-25° C
",12
+692,Lithium Carbonate,lithium-carbonate-692,https://medex.com.bd/attachments/e9rb77QhpWP8de7yaRsbShvscZnHTw/lithium-carbonate-prescribing-information,Anti-manic drugs,Unipolar and bipolar depression,"Treatment and prophylaxis of mania, bipolar disorder and recurrent depression.
","Anti-manic drugs
","Although lithium has been used for over 50 years in treatment of bipolar disorder, the mechanism of action is still unknown. Lithium's therapeutic action may be due to a number of effects, ranging from inhibition of enzymes such as glycogen synthase kinase 3, inositol phosphatases, or modulation of glutamate receptors. Lithium Carbonate alters intraneuronal metabolism of catecholamines and sodium transport in neurons and muscle cells.
","Adult and child over 12 years: initially 1 gm to 1.5 gm daily; prophylaxis, initially 300-400 mg daily. Should be taken with food.
",,"Reduced serum levels with carbonic anhydrase inhibitors, chlorpromazine, sodium-containing preparations, theophylline, urea. Enhanced hypothyroid effects with iodine salts. Enhanced effects of neuromuscular-blocking agents. Reduced pressor response to sympathomimetics.
","Renal insufficiency, cardiovascular insufficiency, Addison's disease and untreated hypothyroidism are all contraindications to lithium therapy.
","Tiredness, loss of appetite, nausea, vomiting, diarrhoea, hands shaking, memory problems, increased thirst and consequently passing urine more often by day, and perhaps also by night.
","Pregnancy Category D. An increased incidence of cardiovascular abnormality has been noted in infants of women given lithium during the first 3 months of pregnancy, such use should be avoided unless essential. Breast feeding is not advised unless the benefits of lithium use outweigh the advantages.
","Decreased tolerance to lithium has been reported to ensue from protracted sweating or diarrhoea and, if such occur, supplemental fluid and salt should be administered under careful medical supervision and lithium intake reduced or suspended until the condition is resolved.
","Renal Impairment: CrCl 10-50: 50-75% of normal dose.
","In the event of accumulation, lithium should be stopped and serum estimations should be carried out every six hours.Under no circumstances should a diuretic be used. Osmotic diuresis (mannitol or urea infusion) or alkalinisation of the urine (sodium lactate or sodium bicarbonate infusion) should be initiated. If the serum lithium level is over 4.0 mmol/L, or if there is a deterioration in the patient's condition, or if the serum lithium concentration is not falling at a rate corresponding to a half-life of under 30 hours, peritoneal or haemodialysis should be instituted promptly. This should be continued until there is no lithium in the serum or dialysis fluid. Serum lithium levels should be monitored for at least a further week to take account of any possible rebound in serum lithium levels as a result of delayed diffusion from body tissues.
",,,"Store at 25° C
",12
+691,Lisinopril,lisinopril-691,https://medex.com.bd/attachments/L8WduLzirZuHEByFYsMd5Wu8hs1dj0/lisinopril-prescribing-information,Angiotensin-converting enzyme (ACE) inhibitors,Myocardial infarction,"Hypertension: Lisinopril is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes ... Read more
Hypertension: Lisinopril is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
Lisinopril may be administered alone or with other antihypertensive agents.
Heart Failure: Lisinopril is indicated to reduce signs and symptoms of heart failure in patients who are not responding adequately to diuretics and digitalis.
Acute Myocardial Infarction: Lisinopril is indicated for the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers
","Angiotensin-converting enzyme (ACE) inhibitors
","Lisinopril competitively inhibits ACE from converting angiotensin I to angiotensin II (a potent vasoconstrictor) resulting in increased plasma renin activity and reduced aldosterone (a hormone that causes water and Na retention) secretion. This promotes vasodilation and BP reduction.
","Oral (Adult)-
+Hypertension: Initially, 10 mg/day, 1st dose given preferably at bedtime to avoid precipitous fall in BP. Patient with renovascular HTN, volume depletion, severe HTN: Initially, 2.5-5 mg once daily. Patient on diuretic: Initially, 5 mg once daily. Maintenance: 20 mg once daily, up to 80 mg/day may be given if needed.
Diabetic nephropathy: Hypertensive type 2 diabetics with microalbuminuria: 10 mg once daily, may increase to 20 mg once daily to achieve a sitting diastolic BP
Heart failure: As adjunct: Initially, 2.5 or 5 mg/day, increased by increments of ≤10 mg at intervals of at least 2 wk to max maintenance dose of 40 mg/day.
Post-myocardial infarction: Initially, 5 mg once daily for 2 days started within 24 hr of the onset of symptoms. Increase to 10 mg once daily. Patients with low systolic BP: Initially, 2.5 mg once daily.
+
Oral (Child)-
+Hypertension: ≥6 yr Initially, 0.07 mg/kg, up to 5 mg once daily.","May be taken with or without food.
","May enhance hypotensive effect with diuretics. May increase risk of renal function deterioration and decrease antihypertensive effect with NSAIDs. May increase serum levels and toxicity of lithium. Increased risk of hyperkalaemia with K-sparing diuretics and K supplements. May increase nitritoid reactions of gold Na thiomalate.
","History of angioedema related to previous ACE inhibitor treatment, hereditary or idiopathic angioedema. Concomitant use with aliskiren in patients with diabetes or renal impairment. Pregnancy. Children with GFR <30 mL/min/1.73 m2.
","Headache, fatigue, persistent and non-productive cough, chest and abdominal pain, dizziness, nausea, vomiting, diarrhoea, upper resp tract infection, asthenia, rash, orthostatic effects, hypotension, renal dysfunction, hyperkalaemia, intestinal angioedema; increased BUN and serum creatinine levels.
","Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Bilateral renal artery stenosis or a single kidney with unilateral renal artery stenosis. Patients with collagen vascular disease, acute MI at risk of further haemodynamic deterioration, angioedema unrelated to ACE inhibitor therapy, aortic stenosis and hypertrophic cardiomyopathy. Increased risk of angioedema in black patients. Renal impairment. Lactation. Childn <6 yr.
","Adult:
+
+- CrCl 10-30 ml/min: Initially, 2.5-5 mg once daily.
+- CrCl 31-80 ml/min: Initially 5-10 mg once daily. Dose can be adjusted up to max 40 mg once daily based on patient's response.
+
+
Child: Do not give if GFR <30 mL/min/1.73 m
2.
","Symptoms: Hypotension, tachycardia, circulatory shock, palpitations, bradycardia, hyperventilation, renal failure, electrolyte disturbances, anxiety, dizziness and cough.
Management: Normal saline IV infusion may be used. Perform haemodialysis, emesis, gastric lavage, admin of absorbents and Na sulfate if recently taken. Consider admin of angiotensin II infusion and/or IV catecholamines if available.
",,,"Store at below 25° C.
",13
+690,Liraglutide,liraglutide-690,https://medex.com.bd/attachments/c3d2RZ2WvpIMNThB0n7FI0oqZhXW9F/liraglutide-prescribing-information,GLP-1 receptor agonists,Type 2 DM,"Liraglutide is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in:
+
+- Adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 ... Read more
Liraglutide is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in:
+
+- Adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g. hypertension, type 2 diabetes mellitus, or dyslipidemia).
+- Pediatric patients aged 12 years and older with body weight above 60 kg and an initial BMI corresponding to 30 kg/m2 for adults (obese) by international cut-offs.
+
","GLP-1 receptor agonists
","Liraglutide is an acylated human glucagon-like peptide-1 (GLP-1) receptor agonist with 97% amino acid sequence homology to endogenous human GLP-1(7-37). Like endogenous GLP-1, liraglutide binds to and activates the GLP-1 receptor, a cell-surface receptor coupled to adenylyl cyclase activation through the stimulatory G-protein, Gs. Endogenous GLP-1 has a half-life of 1.5-2 minutes due to degradation by the ubiquitous endogenous enzymes, dipeptidyl peptidase 4 (DPP-4) and neutral endopeptidases (NEP). Unlike native GLP-1, liraglutide is stable against metabolic degradation by both peptidases and has a plasma half-life of 13 hours after subcutaneous administration. The pharmacokinetic profile of liraglutide, which makes it suitable for once-daily administration, is a result of self-association that delays absorption, plasma protein binding, and stability against metabolic degradation by DPP-4 and NEP.
","Inject Liraglutide subcutaneously in the abdomen, thigh, or upper arm once daily at any time of day, without regard to the timing of meals. The recommended dose of Liraglutide is 3 mg daily. Initiate at 0.6 mg per day for one week. In weekly intervals, increase the dose until a dose of 3 mg is reached. If pediatric patients do not tolerate an increased dose during dose escalation, the dose may also be lowered to the previous level. Dose escalation for pediatric patients may take up to 8 weeks. Pediatric patients who do not tolerate 3 mg daily may have their dose reduced to 2.4 mg daily. Adult patients with type 2 diabetes should monitor blood glucose prior to starting Liraglutide and during Liraglutide treatment.
Pediatric Use: The safety and effectiveness of Liraglutide as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management have been established in pediatric patients aged 12 years and older with body weight above 60 kg.
",,"Liraglutide causes a delay of gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medications. In clinical pharmacology trials, liraglutide did not affect the absorption of the tested orally administered medications to any clinically relevant degree. Nonetheless, monitor for potential consequences of delayed absorption of oral medications concomitantly administered with Liraglutide.
","
+- Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type-2.
+- Hypersensitivity to liraglutide or any excipients in Liraglutide.
+- Pregnancy
+
","Most common adverse reactions, reported in greater than or equal to 5% are: nausea, diarrhea, constipation, vomiting, injection site reactions, headache, hypoglycemia, dyspepsia, fatigue, dizziness, abdominal pain, increased lipase, upper abdominal pain, pyrexia, and gastroenteritis
","Liraglutide is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. There are no available data with liraglutide in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Liraglutide should not be used during pregnancy. If a patient wishes to become pregnant, or pregnancy occurs, treatment with Liraglutide should be discontinued.
There are no data on the presence of liraglutide in human milk, the effects on the breastfed infant, or effects on milk production. Liraglutide was present in the milk of lactating rats. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Liraglutide and any potential adverse effects on the breastfed infant from Liraglutide or from the underlying maternal condition.
","Acute Pancreatitis: Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated.
Hypoglycemia: This can occur in adults when Liraglutide is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin. The risk may be lowered by a reduction in the dose of concomitantly administered insulin secretagogues or insulin. In the pediatric clinical trial, patients did not have type 2 diabetes. Hypoglycemia occurred in Liraglutide-treated pediatric patients. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
Heart Rate Increase: Monitor heart rate at regular intervals.
Renal Impairment: Has been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Liraglutide in patients with renal impairment.
Hypersensitivity Reactions: Postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema). Discontinue Liraglutide and other suspect medications and promptly seek medical advice.
Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts. Discontinue Liraglutide if symptoms develop.
",,"Overdoses have been reported in clinical trials and post-marketing use of liraglutide. Effects have included severe nausea, severe vomiting and severe hypoglycemia. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms.
",,,"Store between 2-8°C. Do not freeze. After initial use, it can be stored between 15-30°C for 30 days. Protect from heat and light.
",11
+1623,Liposome + Perilla + Sodium Hyaluronate,liposome-perilla-sodium-hyaluronate-1623,,Other ophthalmic preparations,Lubrication,"The combined action of liposomes and sodium hyaluronate helps to restore and improve the tear film stability, keeping the ocular surface more hydrated and lubricated. Perilla helps to relieve symptoms of ocular irritation thanks to its anti-inflammatory and antiallergic properties.
","Other ophthalmic preparations
",,,,,,,,,,,,,,2
+688,Linezolid,linezolid-688,https://medex.com.bd/attachments/QDuDsHFlBaya99qN50rIxKzy5cUXGk/linezolid-prescribing-information,Macrolides,Uncomplicated pneumococcal pneumonia,"Vancomycin-Resistant Enterococcus faecium infections including cases with concurrent bacteremia.
Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains) or Streptococcus pneumoniae (including multi-drug resistant strains). Combination therapy ... Read more
Vancomycin-Resistant Enterococcus faecium infections including cases with concurrent bacteremia.
Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains) or Streptococcus pneumoniae (including multi-drug resistant strains). Combination therapy may be clinically indicated if the documented or presumptive pathogens include Gram-negative organism.
Complicated skin and skin structure infections, including diabetic foot infections (without concomitant osteomyelitis) caused by Staphylococcus aureus (methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes or Streptococcus agalactiae.
Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible only) or Streptococcus pyogenes.
Community-acquired pneumonia caused by Streptococcus pneumoniae (including multi-drug resistant strains) including cases with concurrent bacteremia or Staphylococcus aureus (methicillin-susceptible strains only).
","Macrolides
","Linezolid is a synthetic, antibacterial agent belonging to a new class of antibiotics, the oxazolidinones, with in vitro activity against Gram positive aerobic bacteria, some Gram positive anaerobic bacteria and certain Gram negative bacteria. It selectively inhibits bacterial protein synthesis via a mechanism of action different from that of other antibacterial agents. Linezolid binds to the 23S ribosomal RNA of the 50S subunit of the bacterial ribosome and prevents the formation of a functional 70S initiation complex which is an essential component of the bacterial translation process. The results of time-kill studies have shown Linezolid to be bacteriostatic against enterococci and staphylococci. For streptococci, Linezolid was found to be bactericidal for the majority of strains.
","Patients who commence treatment on the parenteral formulation may be switched to oral presentation when clinically indicated. In such circumstances, no dose adjustment is required as Linezolid has an oral bioavailability of approximately 100%. The injection should be administered over a period of 30 to 120 minutes. The film-coated tablets or oral suspension may be taken with or without food.
Complicated skin and skin structure infections, Community-acquired pneumonia, including concurrent bacteremia-
+
+- Pediatric Patients (Birth through 11 Years of Age): 10 mg/kg IV or oral t.i.d.
+- Adults and Adolescents (12 Years and Older): 600 mg IV or oral b.i.d.
+- Recommended Duration of Treatment (consecutive days): 10 to 14
+
+Nosocomial pneumonia, Vancomycin-resistant Enterococcus faecium infections including concurrent bacteremia-
+
+- Pediatric Patients (Birth through 11 Years of Age): 10 mg/kg IV or oral t.i.d.
+- Adults and Adolescents (12 Years and Older): 600 mg IV or oral b.i.d.
+- Recommended Duration of Treatment (consecutive days): 14 to 28
+
+Uncomplicated skin and skin structure infections-
+
+- Pediatric Patients (Birth through 11 Years of Age): <5 yrs: 10 mg/kg oral t.i.d. 5-11 yrs: 10 mg/kg oral b.i.d
+- Adults and Adolescents (12 Years and Older): Adults: 400 mg oral b.i.d. Adolescents: 600 mg oral b.i.d
+- Recommended Duration of Treatment (consecutive days): 10 to 14
+
+
Neonates <7 days: Most pre-term neonates <7 days of age (gestational age <34 weeks) have lower systemic Linezolid clearance values and larger AUC values than many full-term neonates and older infants. These neonates should be initiated with a dosing regimen of 10 mg/kg every 12 hours. Consideration may be given to the use of 10 mg/kg in every eight hours regimen in neonates with a sub-optimal clinical response. All neonatal patients should receive 10 mg/kg t.i.d. by 7 days of life.
","Reconstitution of Oral Suspension: Shake the bottle to loosen powder. Add 75 ml (with the help of given cup) of boiled and cooled water to the dry mixture in the bottle. For the ease of preparation, add water to the bottle in two portions. Shake well after each addition until all the powder is in suspension.
Note: Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place. Use within 21 days after constitution.
Intravenous Administration: Linezolid IV Injection is supplied in single-use, ready-to-use infusion bottles. Linezolid IV Injection should be administered by intravenous infusion over a period of 30 to 120 minutes. The intravenous infusion bottles should not be used in series connections. Additives should not be introduced into this solution. The infusion bottles should be stored at room temperature and protected from freezing. Linezolid IV Injection may exhibit a yellow color that can intensify over time without adversely affecting potency.
","Monoamine Oxidase Inhibition: Linezolid is a reversible and nonselective inhibitor of monoamine oxidase. Therefore, Linezolid has the potential for interaction with adrenergic and serotonergic agents.
Adrenergic Agents: Some individuals receiving Linezolid may experience a reversible enhancement of the pressor response to indirect-acting sympathomimetic agents, vasopressor or dopaminergic agents. Initial doses of adrenergic agents such as dopamine or epinephrine should be reduced and titrated to achieve the desired response.
Serotonergic Agents: Physicians should be alert to the possible signs and symptoms of serotonergic syndrome in patients receiving concomitant Linezolid and serotonergic agents.
","Linezolid formulations are contraindicated for using in patients who have known hypersensitivity to Linezolid or any of the other product components. Linezolid should not be used in patients taking any medicinal product which inhibits monoamine oxidases A or B (e.g. Phenelzine, Isocarboxazid) or within two weeks of taking any such medicinal product. Linezolid should not be administered to patients with uncontrolled hypertension, pheochromocytoma, thyrotoxicosis, carcinoid syndrome and/or patients taking directly and indirectly acting sympathomimetic agents (e.g. Pseudoephedrine), vasopressive agents (e.g. Epinephrine, Norepinephrine), dopaminergic agents (e.g. Dopamine, Dobutamine), serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), meperidine or buspirone.
","Most of the adverse events reported with Linezolid were mild to moderate in intensity. The most common adverse events in patients treated with Linezolid were diarrhea, headache and nausea. Other adverse events includes oral moniliasis, vaginal moniliasis, hypertension, dyspepsia, localized abdominal pain, pruritus, and tongue discoloration.
","Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Linezolid should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Linezolid is excreted in human milk. Because many drugs are excreted in human milk. Caution should be exercised when Linezolid is administered to a nursing woman.
","Patients who develop recurrent nausea or vomiting, unexplained acidosis or low bicarbonate level while receiving Linezolid should receive immediate medical evaluation. Where administration of Linezolid and concomitant serotonergic agents are clinically appropriate, patients should be closely observed for signs and symptoms of serotonin syndrome such as cognitive dysfunction, hyperpyrexia, hyperreflexia and incoordination. If signs or symptoms occur, physicians should consider discontinuation of either one or both agents. If the concomitant serotonergic agent is withdrawn, discontinuation symptoms can be observed. If patients experience symptoms of visual impairment, such as changes in visual acuity, changes in color vision, blurred vision or visual field defect, prompt ophthalmic evaluation is recommended. Convulsions have been reported in patients when treated with Linezolid. In some of these cases, a history of seizures or risk factors for seizures was reported.
",,"No cases of overdose have been reported. Symptomatic and supportive care is advised together with maintenance of glomerular filtration. Approximately 30% of a Linezolid dose is removed during 3 hours of haemodialysis. No data are available for the removal of Linezolid by peritoneal dialysis or haemoperfusion.
",,,"Linezolid formulations should be stored at room temperature (15°C-30°C), away from light and moisture. All medicines should be kept away from children.
",12
+1285,Linagliptin + Metformin Hydrochloride,linagliptin-metformin-hydrochloride-1285,https://medex.com.bd/attachments/mntbVwIK9XjdL6VSUEhJKKv0kcP6Mq/linagliptin-metformin-hydrochloride-prescribing-information,Combination Oral hypoglycemic preparations,Type 2 DM,"This is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both Linagliptin and Metformin Hydrochloride is appropriate
","Combination Oral hypoglycemic preparations
","Linagliptin is indicated to improve glycemic control in patients with type 2 diabetes mellitus. Linagliptin is an inhibitor of DPP-4 (dipeptidyl peptidase-4), an enzyme that degrades the incretin hormones GLP-1 (glucagon like peptide-1) and GIP (glucose dependent insulinotropic polypeptide). Thus, Linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin from pancreatic beta (β) cells in a glucose-dependent manner and decreasing the secretion of glucagon from pancreatic alpha (α) cells in the circulation.
Metformin Hydrochloride is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin Hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
","Linagliptin & Metformin immediate release tablet: The dosage of Linagliptin & Metformin should be individualized on the basis of both effectiveness and tolerability. Maximum recommended dose of 2.5 mg Linagliptin and 1000 mg Metformin Hydrochloride twice daily with meals. Dose escalation should be gradual to reduce the gastrointestinal (GI) side effects associated with Metformin Hydrochloride use.
Recommended starting dose: In patients currently not treated with Metformin Hydrochloride, initiate treatment with 2.5 mg Linagliptin and 500 mg Metformin Hydrochloride twice daily.
In patients already treated with Metformin Hydrochloride, start with 2.5 mg Linagliptin and the current dose of Metformin Hydrochloride twice daily.
Patients already treated with Linagliptin and Metformin Hydrochloride, individual components may be switched to this combination containing the same doses of each component.
Linagliptin & Metformin extend release tablet: The dosage of this combination should be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended total daily dose of Linagliptin 5 mg and Metformin Hydrochloride 2000 mg. this combination should be given once daily with a meal.
Recommended starting dose: In patients currently not treated with metformin, initiate this combination treatment with 5 mg Linagliptin/1000 mg Metformin Hydrochloride extended-release once daily with a meal.
In patients already treated with Metformin, start this combination with 5 mg of Linagliptin total daily dose and a similar total daily dose of Metformin once daily with a meal.
In patients already treated with Linagliptin & Metformin immediate release tablet, switch to extend release tablet containing 5 mg of Linagliptin total daily dose and a similar total daily dose of Metformin once daily with a meal.
5 mg Linagliptin & 1000 mg Metformin Hydrochloride extended-release tablet should be taken as a single tablet once daily. Patients using 2.5 mg Linagliptin & 1000 mg Metformin extended release tablets should take two tablets together once daily.
",,"Cationic drugs (amiloride, digoxin, morphine, ranitidine, trimethoprim etc.): May reduce metformin elimination.
P-glycoprotien/CYP3A4 inducer (i.e. rifampin): The efficacy of this medicine may be reduced when administered in combination.
","Although Linagliptin undergoes minimal renal excretion, Metformin Hydrochloride is known to be substantially excreted by the kidney. The risk of Metformin Hydrochloride accumulation and lactic acidosis increases with the degree of renal impairment. Therefore, this combination is contraindicated in patients with renal impairment. It is also contraindicated in acute or chronic metabolic acidosis (diabetic ketoacidosis) and in hypersensitivity to Linagliptin or Metformin Hydrochloride.
","Most common side effects are nasopharyngitis and diarrhea. Hypoglycemia is more common in patients treated with this combination and sulfonylureas.
","There are no adequate and well-controlled studies in pregnant women with this combination or its individual component; so it should be used during pregnancy only if clearly needed. Caution should also be excercised when it is administered to a lactating mother.
","In a patient with lactic acidosis who is taking Metformin, the drug should be discontinued immediately and supportive therapy promptly instituted. There have been postmarketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue Linagliptin & Metformin. Temporarily discontinue Linagliptin & Metformin in patients undergoing radiologic studies with intravascular administration of iodinated contrast materials or any surgical procedures necessitating restricted intake of food and fluids. Metformin may lower Vitamin B12 levels; so hematologic parameters shoud be monitored annually.
",,"In the event of an overdose with this combination the usual supportive measures (i.e. remove unabsorbed material from the gastrointestinal tract, perform clinical monitoring, and institute supportive treatment) should be employed. Removal of Linagliptin by hemodialysis or peritoneal dialysis is unlikely but Metformin Hydrochloride is dialyzable.
During controlled clinical trials in healthy subjects, with single doses of up to 600 mg of Linagliptin (equivalent to 120 times the recommended daily dose), there were no dose-related clinical adverse drug reactions.
Overdose of Metformin Hydrochloride has occurred in case of ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with Metformin Hydrochloride has been established. Lactic acidosis has been reported in approximately 32% of Metformin Hydrochloride overdose cases.
",,,"Keep in a cool & dry place (below 30°C), protected from light & moisture. Keep out of the reach of children.
",11
+715,Mebeverine Hydrochloride,mebeverine-hydrochloride-715,https://medex.com.bd/attachments/ng7n0X5kxijgPIn8KKLyM6V02fwRJG/mebeverine-hydrochloride-tablets-prescribing-information,Anticholinergics,Spastic or irritable colon,"Mebeverine is indicated for the:
+
+- Symptomatic treatment of irritable bowel syndrome (IBS)
+- Chronic irritable colon
+- Spastic constipation
+- Mucous colitis
+- Colicky abdominal pain
+- Persistent non-specific diarrhoea
+
","Anticholinergics
",,"For adults, elderly and children over 10 years:
+
+- Mebeverine Hydrochloride 135 mg tablet: 1 tablet 03 times daily.
+- Mebeverine Hydrochloride 200 mg capsule: 1 capsule 02 times daily.
+
+This is most effective when taken 20 minutes before meals. After several weeks when the desired effect has been obtained, the dosage may be gradually reduced.
Missed dose: If a dose of this medicine is missed, that should be taken as soon as possible. However, if it is almost time for the next dose, then skip the missed dose and the regular dosing schedule should be maintained. Dose should not be doubled at the same time to compensate the missed dose.
Use in children: Mebeverine is not recommended for children under 10 years.
",,,"Hypersensitivity to the drug or any other ingredients.
","Generally Mebeverine is well tolerated. However, few side-effects like skin rash, urticaria and angioedema may appear
","No teratogenicity has been shown in animal experiments. However, the usual precautions concerning the administration of any drug during pregnancy should be exercised. Mebeverine does not excrete in the breast milk after administering at therapeutic dose.
","Caution should be exercised in porphyria or allergic reaction to this or any other medicine of this group.
",,"On theoretical grounds it may be predicted that CNS excitability will occur in case of overdosage. No specific antidote is known: gastric lavage and symptomatic treatment is recommended
",,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",9
+714,Mebendazole,mebendazole-714,https://medex.com.bd/attachments/TlrYSpF3ubPljwiUrzaS1LWSw60ky9/mebendazole-prescribing-information,Anthelmintic,Worm infections,"Mebendazole is indicated for the treatment of threadworms, whipworms, roundworms and hookworms.
","Anthelmintic
","Mebendazole is a synthetic broad-spectrum anthelmintic that is active against most nematodes and some other worms. Mebendazole is principally used in the treatment of intestinal nematode infection. Mebendazole inhibits the formation of the worms' microtubules and causes the worms' glucose depletion. After oral administration about 2-10% of oral dose is absorbed from Gl tract and peak plasma concentration occurs within 30 minutes to 7 hours. Mebendazole is highly bound to plasma protein. Elimination half-life is 2.8 to 9 hours.
","Adult and Child over 2 years-
+
+- Threadworms: 100 mg or 1 teaspoonful: Single dose.
+- Whipworms, Roundworms, Hookworms: 100 mg or 1 teaspoonful: Twice daily for 3 days.
+
+If reinfection occurs the second dose may be needed after 2 weeks.
",,"Preliminary evidence suggests that cimetidine inhibits mebendazole metabolism and may result in an increase in plasma concentration.
","Mebendazole is contraindicated in patients with known hypersensitivity to Mebendazole, or to any component of the formulation.
","
+- Gastrointestinal: Transient symptoms of abdominal pain and diarrhoea in case of massive infection and expulsion of worms.
+- Hypersensitivity: Rash, urticaria and angioedema have been observed on rare occasions.
+- Central Nervous System: Very rare cases of convulsions have been reported.
+- Haematologic: Neutropenia and agranulocytosis.
+
","Mebendazole is not recommended in pregnant women. It is not known whether mebendazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when it is administered to a nursing mother.
","General: Periodic assessment of organ system functions, including haematopoietic and hepatic, is advisable during prolonged therapy.
Information for Patients: Patients should be informed of the potential risk to the foetus in women taking mebendazole during pregnancy, especially during the first trimester. Patients should also be informed that cleanliness is important to prevent reinfection & transmission of the infection.
","Paediatric use: The drug has not been extensively studied in children under two years; therefore, in the treatment of children under two years the relative benefit/risk should be considered.
","In the event of accidental overdosage, gastrointestinal complaints lasting up to a few hours may occur. Vomiting and purging should be induced.
",,,"Store in a cool (Below 25°C temperature) and dry place, protected from light. Keep out of the reach of children.
",12
+713,Measles and Rubella,measles-and-rubella-713,https://medex.com.bd/attachments/nxF0GJzo6JZ2HDzkU5EhsEzwSRXUWS/measles-and-rubella-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Measles,"This is indicated for simultaneous immunization against measles and rubella in persons older than 8 months.
","Vaccines, Anti-sera & Immunoglobulin
",,"Adults and Children: A single dose of 0.5 ml of the reconstituted vaccine given by deep subcutaneous injection. Do not give intravenously.
EPI schedule: After completion of 9 months, 1 dose of measles-rubella vaccine should be given. After completion of 15 months, 1 dose of only measles containing vaccine should be given.
",,,"Allergic to any ingredient in the vaccine. Suffering from acute diseases, severe chronic diseases, acute exacerbation of chronic diseases and fever. Pregnant women. Immune deficiency, immune dysfunction or receiving immunosuppressive therapy. Suffering from encephalopathy, uncontrolled epilepsy and other progressive neurological diseases.
","Common side-effects:
+
+- Generally pain and tenderness at the injection site may occur within 24 hours after vaccination, which usually disappear by itself within 2-3 days.
+- Generally transient fever reaction may occur within 1-2 weeks after vaccination.
+- Rash: generally mild rash may occur within 12 days after vaccination, which generally lasts for no more than 2 days.
+
+Rare side-effects:
+
+- Severe fever reaction: physical methods and drugs should be used for symptomatic treatment to prevent febrile seizures.
+
+Very rare side-effects:
+
+- Allergic rash: generally urticaria may occur within 72 hours after vaccination, and if this reaction occurs, anti-allergy treatment should be timely given.
+- Anaphylactic shock: generally occurs within 1 hour after vaccination. Injection of epinephrine and other emergency measures should be timely given for treatment.
+- Anaphylactoid purpura: medical care should be timely given if anaphylactoid purpura occurs. Cortical steroids can be given for anti-allergy treatment. Improper or not timely treatment is likely to cause anaphylatic purpura nephritis.
+- Thrombocytopenia purpura.
+- Adults may develop arthritis, pain and swelling of large joints after vaccination.
+
","Pregnancy category C. Pregnancy should be avoided for 3 months following vaccination. Caution should be exercised when Measles and Rubella vaccine is administered to a nursing woman.
","The vaccine should not be used if vaccine bottle has cracks or unclear labels, the vaccine is beyond shelf life, and abnormal appearance (such as turbidity) is observed after reconstitution. The vaccine should be used immediately after opening. Epinephrine and other drugs should be prepared for emergency use in case of occasional severe allergic reaction. The people receiving vaccination should be observed at the site for at least 30 minutes after injection. The people receiving injection of immune globulin should be vaccinated with an interval of at least 3 months so as not to affect the immune effect. Other attenuated live vaccine should be vaccinated with an interval of at least 1 month from this vaccine, but this vaccine can be vaccinated simultaneously with attenuated live mumps vaccine. This product is an attenuated live vaccine and it is not recommended to be used in the epidemic season. Women of childbearing age should avoid pregnancy within at least 3 months after injection of this vaccine. Freezing is prohibited.
",,,,,"Keep out of the reach and sight of children. Store at +2°C to +8°C. Transportation should also be at +2°C to +8°C. Do not freeze. Discard vaccine if frozen. Protect from light.
",8
+712,Maprotiline Hydrochloride,maprotiline-hydrochloride-712,https://medex.com.bd/attachments/aEpyshU0dUBRSEXwzxNz7wGxVc9ZNj/maprotiline-hydrochloride-prescribing-information,Tricyclic Anti-depressant,Major depressive disorder,"Maprotiline hydrochloride tablets are indicated for the treatment of depressive illness in patients with depressive neurosis (dysthymic disorder) and manic depressive illness, depressed type (major depressive disorder). Maprotiline is also effective for the relief of anxiety associated with depression
","Tricyclic Anti-depressant
","The mechanism of action of maprotiline is not precisely known. It does not act primarily by stimulation of the central nervous system and is not a monoamine oxidase inhibitor. The postulated mechanism of maprotiline is that it acts primarily by potentiation of central adrenergic synapses by blocking reuptake of norepinephrine at nerve endings. This pharmacologic action is thought to be responsible for the drug's antidepressant and anxiolytic effects.
","A single daily dose is an alternative to divided daily doses. Therapeutic effects are sometimes seen within 3 to 7 days, although as long as 2 to 3 weeks are usually necessary.
Initial Adult Dosage: An initial dosage of 75 mg daily is suggested for outpatients with mild to moderate depression. However, in some patients, particularly the elderly, an initial dosage of 25 mg daily may be used. Because of the long half-life of maprotiline, the initial dosage should be maintained for 2 weeks. The dosage may then be increased gradually in 25 mg increments as required and tolerated. In most outpatients, a maximum dose of 150 mg daily will result in therapeutic efficacy. It is recommended that this does not be exceeded except in the most severely depressed patients. In such patients, dosage may be gradually increased to a maximum of 225 mg.
More severely depressed, hospitalized patients should be given an initial daily dose of 100 mg to 150 mg which may be gradually increased as required and tolerated. Most hospitalized patients with moderate to severe depression respond to a daily dose of 150 mg although dosages as high as 225 mg may be required in some cases. The daily dosage of 225 mg should not be exceeded.
Elderly Patients: In general, lower dosages are recommended for patients over 60 years of age. Dosages of 50 mg to 75 mg daily are usually satisfactory as maintenance therapy for elderly patients who do not tolerate higher amounts.
",,"Close supervision and careful adjustment of dosage are required when administering maprotiline concomitantly with anticholinergic or sympathomimetic drugs because of the possibility of additive atropine-like effects. Concurrent administration of maprotiline with electroshock therapy should be avoided because of the lack of experience in this area.
Caution should be exercised when administering maprotiline to hyperthyroid patients or those on thyroid medication because of the possibility of enhanced potential for cardiovascular toxicity of maprotiline.
Maprotiline should be used with caution in patients receiving guanethidine or similar agents since it may block the pharmacologic effects of these drugs.
The risk of seizures may be increased when maprotiline is taken concomitantly with phenothiazines or when the dosage of benzodiazepines is rapidly tapered in patients receiving maprotiline.
Because of the pharmacologic similarity of maprotiline hydrochloride to the tricyclic antidepressants, the plasma concentration of maprotiline may be increased when the drug is given concomitantly with hepatic enzyme inhibitors (e.g., cimetidine, fluoxetine) and decreased by concomitant administration with hepatic enzyme inducers (e.g., barbiturates, phenytoin), as has occurred red with tricyclic antidepressants. Adjustment of the dosage of maprotiline hydrochloride may therefore be necessary in such cases
","Maprotiline hydrochloride tab lets are contraindicated in patients hypersensitive to maprotiline and in patients with known or suspected seizure disorders. It should not be given concomitantly with monoamine oxidase (MAO) inhibitors. A minimum of 14 days should be allowed to elapse after discontinuation of MAO inhibitors before treatment with maprotiline is initiated. Effects should be monitored with gradual increase in dosage until optimum response is achieved. The drug is not recommended for use during the acute phase of myocardial infarction.
","Cardiovascular: Rare occurrences of hypotension, hypertension, tachycardia, palpitation, arrhythmia, heart block, and syncope have been reported with maprotiline.
Psychiatric: Nervousness (6%), anxiety (3%), insomnia (2%), and agitation (2%); rarely, confusional states (especially in the elderly), hallucinations, disorientation, delusions, restlessness, nightmares, hypomania, mania, exacerbation of psychosis, decrease in memory, and feelings of unreality
Neurological: Drowsiness (16%), dizziness (8%), tremor (3%), and, rarely, numbness, tingling, motor hyperactivity, akathisia, seizures, EEG alterations, tinnitus, extrapyramidal symptoms, ataxia, and dysarthria.
Anticholinergic: Dry mouth (22%), constipation (6%), and blurred vision (4%); rarely, accommodation disturbances, mydriasis, urinary retention, and delayed micturition.
Allergic: Rare instances of skin rash, petechiae, itching, photosensitization, edema, and drug fever.
Gastrointestinal: Nausea (2%) and, rarely, vomiting, epigastric distress, diarrhea, bitter taste, abdominal cramps and dysphagia.
Endocrine: Rare instances of increased or decreased libido, impotence, and elevation or depression of blood sugar levels.
","Pregnancy Category B. Reproduction studies have been performed in female laboratory rabbits, mice, and rats at doses up to 1.3, 7, and 9 times the maximum daily human dose respectively and have revealed no evidence of impaired fertility or harm to the fetus due to maprotiline. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Labor and Delivery: Although the effect of maprotiline on labor and delivery is unknown, caution should be exercised as with any drug with CNS depressant action.
Nursing Mothers: Maprotiline is excreted in breast milk. At steady-state, the concentrations in milk correspond closely to the concentrations in whole blood. Caution should be exercised when maprotiline hydrochloride is administered to a nursing woman.
","The possibility of suicide in seriously depressed patients is inherent in their illness and may persist until significant remission occurs. Therefore, patients must be carefully supervised during all phases of treatment with maprotiline, and prescriptions should be written for the smallest number of tablets consistent with good patient management. Hypomanic or manic episodes have been known to occur in some patients taking tricyclic antidepressant drugs, particularly in patients with cyclic disorders. Such occurrences have also been noted, rarely, with maprotiline. Prior to elective surgery, ma protiline should be discontinued for as long as clinically feasible, since little is known about the interaction between maprotiline and general anesthetics. Maprotiline should be administered with caution in patients with a history of urinary retention, or a history of narrow-angle glaucoma because of the drug’s anticholinergic properties.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+711,Mannitol,mannitol-711,https://medex.com.bd/attachments/m5DrnXEUWjdCOnk06VIfM01TRoZdYp/mannitol-prescribing-information,Osmotic diuretics,Elevated intraocular pressure,"Mannitol is principally used by IV infusion as an osmotic diuretic to preserve renal function in acute renal failure and to reduce raised intracranial and intraocular pressure. Mannitol is also used as an irrigating solution to prevent hemolysis and hemoglobin buildup during transurethral prostatic ... Read more
Mannitol is principally used by IV infusion as an osmotic diuretic to preserve renal function in acute renal failure and to reduce raised intracranial and intraocular pressure. Mannitol is also used as an irrigating solution to prevent hemolysis and hemoglobin buildup during transurethral prostatic resection. It is useful in the management of acute drug poisoning where a route of elimination is through kidney. Besides these, it is also used in symptomatic relief of edema, reperfusion injury, termination of pregnancy, and bowel preparation. So, Mannitol is indicated in-
+
+- Renal insufficiency
+- Reperfusion injury
+- Raised intracranial pressure
+- Bladder irrigation
+- Raised intraocular pressure
+- Bowel preparation
+- Edematous status
+- As a prophylactic in renal failure
+- Management of poisoning
+- Termination of Pregnancy
+
","Osmotic diuretics
",,"The adult dose of Mannitol ranges from 50 to 100 gm by IV infusion. The rate of administration is usually adjusted to maintain a urine flow of at least 30 to 50 ml/hr. Total dosage, concentration and the rate of administration depends on fluid requirement, urinary output and the severity of the condition being treated
Renal insufficiency-
+
+- Adults: 50 to 100 g of Mannitol administered at a rate adjusted to maintain a urine flow of at least 30 to 50 ml/hr.
+- Children: 2 gm/kg or 60 gm/m2 of body surface area administered over a period of 2 to 6 hrs.
+
+Cerebral edema, elevated intracranial pressure, elevated intraocular pressure, Glaucoma-
+
+- Adults: 1.5 to 2 gm/kg administered over a period of 30 to 60 minutes.
+- Children: 1 to 2 gm/kg body wt. or 30 to 60 gm/m2 of body surface area administered over a period of 30 to 60 mins.
+
+Adjunctive therapy for removal of toxic substances-
+
+- Adults: 50 to 200 g of Mannitol administered at a rate adjust to maintain a urine flow of at least 100 to 500 ml/hr.
+- Children: 2 gm/kg or 60 gm/m2 of body surface area
+
+For termination of pregnancy 50 gm of Mannitol (250 ml of Mannitol) is instilled into the amniotic cavity which induces abortion in a high proportion of pregnancies.
",,,"Mannitol intravenous infusion is contraindicated in patients with pulmonary edema or congestive heart failure. It is also contraindicated during inadequate urine flow, dehydration or acidosis, intracranial bleeding and in patients with renal failure unless a test dose has produced a diuretic response.
","The most common side effects associated with Mannitol intravenous infusion is fluid and electrolytes imbalance including circulatory overload and acidosis at high doses. Other side effects include nausea, vomiting, thirst, headache, dizziness, fever, tachycardia, chest pain, hyponatraemia, dehydration, blurred vision, urticaria, and hypertension or hypotension.
","Safety of Mannitol intravenous infusion in pregnancy has not been established yet. No information is available on the excretion of mannitol in breast milk and should be administered after careful consideration of risk-benefit ratio.
","Careful monitoring of rate of administration of Mannitol is necessary to avoid fluid and electrolyte imbalance and circulatory overloading. The infusion should be discontinued if the patient develops signs of progressive renal dysfunction, heart failure or pulmonary congestion. Mannitol should not be administered with whole blood. Infusion of fluid should be immediately discontinued if rigor arises from any reason during the process. Do not use if the solution is cloudy, contains particles or after expiry date.
",,,,,"Mannitol should be stored at a temperature of 20° to 30°. Exposure to lower temperatures may cause deposition of crystals, which should be dissolved by warming the bottle in hot water for about 30 minutes. Cool to body temperature before using. If all crystals can not be dissolved, the solution should not be used. The content of open containers should be used promptly. Unused contents should be discarded.
",8
+1551,Magnesium Sulfate Heptahydrate,magnesium-sulfate-heptahydrate-1551,,Specific mineral preparations,Tetanus,"Magnesium Sulphate Heptahydrateis indicated in the following conditions:
+
+- To prevent convulsion in patients with preeclampsia, eclampsia, tetanus and acute uraemia.
+- In acute myocardial infarction, arrythmia.
+- To arrest premature labour.
+- As an adjuvant in neurosurgery to lower the C.S.F pressure.
... Read more
Magnesium Sulphate Heptahydrateis indicated in the following conditions:
+
+- To prevent convulsion in patients with preeclampsia, eclampsia, tetanus and acute uraemia.
+- In acute myocardial infarction, arrythmia.
+- To arrest premature labour.
+- As an adjuvant in neurosurgery to lower the C.S.F pressure.
+- For replacement therapy in hypomagnesaemia
+- To control hypertension, encephalopathy and convulsion associated with acute nephritis in children.
+
","Specific mineral preparations
","Magnesium is the second most plentiful cation of intracellular fluid and is involved in a wide range of activities. It is needed for activity of many enzymes and plays a role in neurochemical transmission and muscular excitability. Abnormally low concentration of magnesium in the ECF results in increased acetylcholine release and increased muscle excitability that can produce tetany. Magnesium Sulphate heptahydrate has anticonvulsant properties when administered parenterally. An increased concentration of magnesium in the ECF causes depression of the central nervous system ( CNS). Magnesium has a direct effect on skeletal muscle. Hypomagnesaemia may develop from diarrhoea, stoma or fistula, alcoholism or diuretic therapy, prolonged treatment with aminoglycosides, hypocalcaemia, hypokalaemia and hyponatraemia.
After administration 25-30% of magnesium is protein bound. It is excreted mainly in the urine, over 90% of magnesium filtered by the kidney is reabsorbed. Small amounts are excreted in the faeces, breast milk and saliva. Magnesium also crosses the placenta.
","Usual dose range: Upto 40 gm daily at a rate not exceeding 3 ml per minute
Seizure prophylaxis in Preeclampsia and Eclampsia: A loading dose of 4 gm (100 ml) over upto 20 minutes followed by a maintenance dose of 2 gm (50 ml) per hour. Recurrence of seizure may require an additional I.V bolus of 8-16 mmol (upto 100 ml). For seizure prophylaxis, treatment should continue during labour and for atleast 24 hours after delivery.
In Myocardial infarction: 8 mmol (50 ml) over 20 minutes, then 65 mmol (400 ml) over 24 hours.
In Magnesium deficiency: 0.5-1 mmol/kg/day (200 ml to 400 ml) on the first day followed by 25 mmol (150 ml) daily, upto 160 mmol (1000 ml) over upto 5 days.
In Tetanus: An infusion of Magnesium Sulphate sufficient to maintain a blood magnesium concentration of 2.5 to 4 mmol per litre has been recommended.
In arrythmia: 8 mmol (50 ml) over 10-15 minutes (repeated once if needed)
",,"Concomitant use of magnesium salts with barbiturates, narcotics, hypnotics or other C.N.S depressants need dose adjustment because of additive effect on C.N.S.
","It is contraindicated in patients with heart block or myocardial damage.
","Excessive administration of magnesium results in hypermagnesaemia manifested by nausea, vomiting, flushing of the skin, thirst, hypotension, drowsiness, confusion, loss of tendon reflexes, respiratory depression, cardiac arrest etc
","Magnesium Sulphate crosses the placenta. So, as with any other drugs, caution is required when the drug is administered to pregnant women. It is not known whether the drug is excreted in human milk. As it happens with many other drugs, cautions should be taken when it is administered to a nursing mother.
","Magnesium salts should be used with caution in patients with impaired renal and hepatic function. Infusion of fluid should be immediately discontinued if rigor arises from any reason during the process. Do not use if the bottle is leaking, solution is cloudy, contains particles or after expiry date.
",,"Magnesium Sulphate overdose can be treated with 10ml of 10% calcium gluconate or chloride intravenously. If the renal function is normal, adequate fluid should be given. Dialysis may be performed in renal impairment.
",,,"Store at controlled room temperature. Protect from light. This IV infusion is not intended for multi-dose use.
",11
+710,Magnesium Sulfate,magnesium-sulfate-710,https://medex.com.bd/attachments/xYeyAV8DLMz7Hc4xxuTILCEqr8rlW5/magnesium-sulfate-prescribing-information,Specific mineral preparations,Hypomagnesemia,"Magnesium sulfate injection is indicated mainly for the treatment of acute hypomagnesemia and magnesium deficiency states. Magnesium sulfate also has anticonvulsant properties. It can be used for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively.
","Specific mineral preparations
","Magnesium is an important cofactor for enzymatic reactions. It plays an important role in neurochemical transmission and muscular excitability. Magnesium deficiency is accompanied by a variety of different structural and functional disturbances
","Intramuscular: Adults and older children: For severe hypomagnesemia, 1 to 5 gm (2 to 10 ml of 50% solution) daily in divided doses; administration is repeated daily until serum levels have returned to normal. If deficiency is not severe, 1 gm (2 ml of 50% solution) can be given once or twice daily. Serum magnesium levels should serve as a guide to continued dosage.
Intravenous: 1 to 4 gm magnesium sulfate (magnesium sulfate (magnesium sulfate injection) injection) may be given intravenously in 10% to 20% solution, but only with great caution; the rate should not exceed 1.5 ml of 10% solution or equivalent per minute until relaxation is obtained.
Usual Dose Range: 1 to 40 gm daily.
Electrolyte Replenisher: Intramuscular 1 to 2 gm in 50% solution four times a day until serum magnesium is within normal limits.
Usual Pediatric Dose: Intramuscular 20 to 40 mg per kg of body weight in a 20% solution repeated as necessary.
For Eclampsia: Initially 1 to 2 gm in 25% or 50% solution is given intramuscularly. Subsequently, 1 gm is given every 30 minutes until relief is obtained. The blood pressure should be monitored after each injection.
",,"The dosage of barbiturates, narcotics or other hypnotics (or systemic anesthetics), or other CNS depressants should be adjusted with caution when given in conjunction with magnesium due to the additive depressant effects of magnesium. There may be an increase in the effects of neuromuscular blocking agent when given together with magnesium sulfate. Magnesium sulfate may cause a reduction in blood pressure when administered together with calcium channel blockers.
","Magnesium Sulfate contra-indicated in the case of defect of the heart's electrical message pathways resulting in decreased function of the heart (heart block), severe damage to the muscular wall of the heart (myocardium) and significantly decreased kidney function.
","The most common side effect is hypermagnesaemia developing from excessive administration of magnesium. Symptoms of hypermagnesaemia may include nausea, vomiting, flushing of skin, thirst, hypotension due to peripheral vasodilatation, drowsiness, confusion, muscle weakness etc. Rarely diarrhea or skin irritation after soaking may occur.
","Pregnancy: Magnesium sulfate injection should be used during pregnancy only if clearly needed. Magnesium sulfate is not known to be harmful for short-term intravenous administration in eclampsia but excessive doses cause neonatal respiratory depression. It is not known whether the drug is excreted in human milk. As it happens with many other drugs, cautions should be taken when it is administered to a nursing mother.
","Magnesium salts should be administered with caution to patients with impaired renal function or those receiving digitalis glycosides. Parenteral administration of magnesium salts may enhance the effect of neuromuscular blocking agents or of central nervous system depressants. Monitor blood pressure, respiratory rate, urinary output and for signs of over dosage like loss of patellar reflex, weakness, nausea, sensation of warmth, flushing of skin, drowsiness, double vision and slurred speech.
",,"Symptoms of magnesium intoxication are a sharp drop in blood pressure and respiratory paralysis. In the event of overdose, artificial ventilation must be provided until a calcium salt can be injected IV to antagonize the effects of magnesium.
",,,"Store in a cool & dry place, keep away from light & children.
",11
+1853,Magnesium Oxide,magnesium-oxide-1853,,Electrolytes preparations,,"Magnesium Oxide is indicated for the treatment of following condition:
+
+- Relieving the symptoms of magnesium defciency
+- Cardiovascular system: Rapid heartbeat, heart rate irregularity, heart attack, angina pectoris (chest pain caused by narrowing / obstruction of heart-feeding vessels), mild severe hypertension
... Read more
Magnesium Oxide is indicated for the treatment of following condition:
+
+- Relieving the symptoms of magnesium defciency
+- Cardiovascular system: Rapid heartbeat, heart rate irregularity, heart attack, angina pectoris (chest pain caused by narrowing / obstruction of heart-feeding vessels), mild severe hypertension
+- Nervous system and muscles: Sudden and excessive contractions (tetania) in the muscles, muscle cramp, gastrointestinal cramps, increased stimulability of muscles and nerves, calf cramps, cramp conditions in newborn and young children and stress
+- Gynecological diseases, birth and pregnancy: Pre-term contraction, cervical insufciency, premature membrane rupture, contractions during pregnancy (eclampsia [Disease with seizures, blood pressure increase, protein in the urine, water retention in body during pregnancy]/preeclampsia [Disease with blood pressure increase, protein in the urine, water retention in body during pregnancy]), tocolysis requiring the use of beta mimetic (interruption of the uterine contractions), dysmenorrhea.
+- Orthopedics: Calcifcation and ossifcation
+- Prevention of kidney stone formation (prevention of recurrence of calcium oxalate urolithiasis)
+- Diabetes treatment and migraine (a kind of headache)
+
","Antacids, Electrolytes preparations, Oral electrolytes preparations
","Pharmacology: Magnesium is the second most abundant intracellular divalent cation and is a cofactor for more than 300 metabolic reactions in the body. These processes include protein synthesis, cellular energy production and storage, cell growth and reproduction, DNA and RNA synthesis, and stabilization of mitochondrial membranes. Magnesium is one of the minerals responsible for managing bone metabolism, nerve transmission, cardiac excitability, neuromuscular conduction, muscular contraction, vasomotor tone, and blood pressure. Magnesium also plays a significant role in glucose and insulin metabolism, mainly through its impact on tyrosine kinase activity, phosphorylase b kinase activity, and glucose transporter protein activity. Because of these vital roles, magnesium levels may be affected by stressors to the body, such as in certain disease states. Supplementation with magnesium may have therapeutic effects in these situations.
Pharmacokinetics: Absorption of a micronutrient as Mg is affected by other nutrients and reaches an estimated 30–50% of dietary Mg intake at basal conditions, while the absorption fraction declines with age and raising Mg intake. The drug absorption depends on both the kind of Mg salt and other food elements that may either augment or abate it. The distribution of Mg is mainly intracellular, <1% circulates in the blood (both extracellularly and intracellularly), and total serum Mg comprises three states with roughly 60% ionized, 33% protein-bound and 7% anion complexed. Elimination of Mg is handled by renal filtration with 25% being reabsorbed in the proximal convoluted tubule and further 50–60% is reabsorbed in the loop of Henle. Around 70–80% of plasma Mg undergoes glomerular filtration, but merely 3% is eventually excreted in the urine.
","Magnesium supplements must be taken with meal to reduce stomach upset and diarrhea. The recommended daily dose for adults and adolescents (12-17 years) is 1-2 tablets.
Kidney failure: Should not be used in patients with severe kidney insufficiency.
Liver failure: There are no data on patients with liver insufficiency.
Usage in the elderly: There is no data on the use in elderly patients.
",,"Other medicines can affect treatment with Magnesium Oxide tablet. If you are using any of the following: medicines, tell your doctor; muscle relaxants (non-depolarizing neuromuscular blockers), aminoquinolones, nitrofurantoin, penicillamine, tetracyclines, fluoroquinolones (antibiotics), Digoxin (for the treatment of heart failure), Lithium (Control of emotional changes and depression), Sodium polystyrene sulfonate (allows potassium to be removed from the body), Cellulose sodium phosphate (used to prevent kidney stones), Other medicines containing magnesium (including magnesium enemas), Barbiturates (drugs used for the treatment of insomnia), opioids (substances that act as morphine in the body), hypnotics (soporific), Nifedipine (drugs used in high blood pressure or heart problems).
","Hypersensitivity and severe renal impairment.
","Mild side effects include-Nausea, Vomiting, Diarrhea, Cramp, Tiredness, Weakness, Confusion. These side effects disappear when the dose is reduced or treatment is discontinued. Serious side effects include low blood pressure, changes in the recording of the heart's electrical activity (ECG), depression, severe allergic reaction (e.g. swelling in mouth and throat, itching, rash, redness), respiratory depression, coma. These may require emergency medical treatment. These serious side efects occur very rarely.
","The recommended daily dose in pregnancy and lactation is 1-2 tablets. (During pregnancy & lactation, this product should be used only when clearly needed).
","This product may contain inactive ingredients, which can cause allergic reactions or other problems. If anyone has the following health problem, consult with doctor before using this product: kidney disease, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires limit/avoid these substances from diet.
",,"Symptoms of overdose may include slow heartbeat, severe dizziness, confusion, muscle weakness, loss of consciousness, diarrhea and hypermagnesemia.
",,,"Store below 25°C. Protected from light and moisture. Keep all medicines out of the reach of children.
",11
+689,Magnesium Hydroxide + Liquid Paraffin,magnesium-hydroxide-liquid-paraffin-689,,Antacid with laxative action,Constipation,"This preparation is indicated in-
+
+- Constipation
+- Hyperacidity with constipation
+- Anorectal disorder
+- Post-operative constipation
+- Constipation associated with chronic cholecystitis
+- Hernia
+
","Antacid with laxative action
","This preparation has a dual-relief formulation containing a gentle laxative ingredient and a lubricant which eases the discomfort associated with straining and bowel movement. It is recommended for the temporary relief of constipation
","The recommended oral dose are as follows-
Adults: 15-30ml before breakfast or at bedtime.
Children:
+
+- Over 7 years: 7.5 ml-15 ml at bedtime.
+- 3-7 years: 5-10 ml at bedtime.
+
+The dose may be mixed with milk or half a glass of water if desired. Don't take for more than 1 week unless under doctor's supervision
",,"Cimetidine, Diuretics, Famotidine and Ranitidine may cause irritation of stomach or bowel.
","Acute Gl conditions like abdominal pain.
","Rectal irritation, potassium loss (thirst, weakness, nausea and diarrhea).
","Can be given to pregnant and lactating mother.
","Renal and hepatic impairment. Maintain adequate fluid intake.
",,"There are no reported cases of overdosage.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+708,Magnesium Hydroxide,magnesium-hydroxide-708,https://medex.com.bd/attachments/mQVq85snjKxv7xtSI6UsEbXMfS82np/magnesium-hydroxide-prescribing-information,Antacid with laxative action,Osmotic laxative,"Magnesium Hydroxide suspension is used in constipation, heart burn, gas and nausea. It is also indicated in acute and long acting constipation due to hyper acidity and peptic ulcer or stomatitis.
","Antacid with laxative action
","Magnesium Hydroxide is popularly known as Milk of Magnesia. It is a mildly acting antacid and laxative. It is poorly and slowly absorbed and acts by its osmotic properties in the luminal fluid which causes retention of fluid in the bowel. It is useful for emptying the bowel prior to surgical, radiological and colonoscopic procedures and can help to eliminate parasites following appropriate therapy and toxic material in some cases of poisoning. Magnesium Hydroxide is converted into Magnesium Chloride in the stomach without forming carbon dioxide
","As Laxative:
+
+- Adults: 2-4 Tablespoonful with a full glass of water.
+- Children: 6-11 years: 1-2 Tablespoonful with a full glass of water. 2-5 years: 1-3 Teaspoonful with a full glass of water.
+
+As Antacid:
+
+- Adults: 1-3 teaspoonful (5 to 15 ml) up to 4 times daily with water.
+- Children: 1-3 years: ¼ teaspoonful. 3-6 years: ¼-½ teaspoonful. 6-12 years: ½-1 teaspoonful
+
",,"Magnesium hydroxide can decrease the absorption of other drugs such as, digoxin, mycophenolate, phosphate supplements (e.g., potassium phosphate), tetracycline antibiotics, certain azole antifungals (ketoconazole, itraconazole), and quinolone antibiotics (e.g., ciprofloxacin, levofloxacin).
","Magnesium Hydroxide should not be administered where use of laxative is contraindicated. Long term treatment of Magnesium Hydroxide is contraindicated in patients with renal failure.
","Magnesium Hydroxide in common with other magnesium salts may cause diarrhoea.
",,"The drug should be avoided if possible in patients with renal and hepatic failure and in those with heart block and myocardial disease. The drug may be used cautiously in pregnancy.
",,,,,"Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.
",9
+707,Magaldrate + Simethicone,magaldrate-simethicone-707,,Antacids,Peptic ulcer disease,"This is indicated to relieve symptoms of dyspepsia, heartburn, acid indigestion, sour stomach, gastroesophageal reflux and hiatal hernia. It is also prescribed in hyperacidity associated with peptic ulcers, gastritis and esophagitis. Magaldrate may be given to children if necessary. Also indicated for the relief of flatulence, abdominal distension and windy colic.
","Antacids, Anti-dyspeptic/Carminatives
","This is a combination of magaldrate and simethicone. Magaldrate (magnesium aluminium compound i.e. Hydroxymagnesium Aluminate), which neutralizes gastric acid extraordinarily quickly without raising the pH above 5-6. It also decreases the activity of pepsin in gastric secretion. Besides this, simethicone, the another component of Marlox Plus, enables the gas buble to coalesce and give relief from flatulence.
","Tablet: 1-4 chewable tablets, 20 to 60 minutes after meals and at bedtime, or as directed by the physician.
Suspension: 2-4 teaspoonfuls (10-20 ml) of suspension, 20 to 60 minutes after meals and at bed time, or as directed by the physician.
",,"It should not be used in patients taking any form of Tetracycline. The drug may cause reduced bio-availability or slower absorption of a number of drugs including propranolol, isoniazid, prednisolone and naproxen.
","Magaldrate is contraindicated in patients with known hypersensitivity to magnesium and aluminium. It is also contraindicated in patients with impaired renal functions.
","Gastrointestinal side-effects are uncommon. Occasionally, if excessive amount is consumed, diarrhea, constipation or regurgitation may occur.
","Magaldrate may be used in pregnancy if indicated however one should avoid excessive dosage. Magaldrate may pass into breast milk but has not been reported to cause problem in nursing babies.
","Care should be taken in decreased kidney function, hypophosphataemia and weak people.
",,"Over dosage with this formulation is a rare case.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+706,Magaldrate,magaldrate-706,,Antacids,Peptic ulcer disease,"Magaldrate is indicated to relieve symptoms of dyspepsia, heartburn, acid indigestion, sour stomach, gastroesophageal reflux, hiatal hernia and flatulence. It is also prescribed in hyperacidity associated with peptic ulcers, gastritis and esophagitis. Magaldrate may be given to children if necessary.
","Antacids, Anti-dyspeptic/Carminatives
","Magaldrate is a hydroxymagnesium aluminate complex that is converted rapidly in gastric acid to Mg(OH)2 and Al(OH)3, which are absorbed poorly and thus provide a sustained antacid effect
","Tablet: 1-3 tablets, after meals and at bed time or as directed by the physician.
Syrup: 2 to 3 teaspoonful, 3 or 4 times daily, half to one hour after or before meal and at bedtime
",,,"Magaldrate is contraindicated in patients with known hypersensitivity to magnesium and aluminium. It is also contraindicated in patients with impaired renal function
","Constipation and diarrhea may occur.
","Pregnant women: Magaldrate may be used in pregnancy if indicated however one should avoid excessive dosage.
Lactating mother: Magaldrate may pass into breast milk but has not been reported to cause problem in nursing babies.
",,,,,,,7
+722,Macrogol [Polypropylene glycol] + Electrolytes,macrogol-polypropylene-glycol-electrolytes-722,https://medex.com.bd/attachments/WHKEiemoWTt89oeXZJdLuuarSEML46/macrogol-polypropylene-glycol-electrolytes-prescribing-information,Osmotic purgatives,Faecal impaction,"For use in adults and children over 12 years of age for effective relief from constipation and treatment of chronic constipation. Also effective in resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and colon.
","Osmotic purgatives
","Macrogol (3350) exerts an osmotic action in the gut, which induces a laxative effect. Macrogol (3350) increases the stool volume, which triggers colon motility via neuromuscular pathways. The physiological consequence is an improved propulsive colonic transportation of the soften stools and a facilitation of the defecation. Electrolytes combined with Macrogol (3350) are exchanged across the intestinal barrier (mucosa) with serum electrolytes and excreted without net gain or loss of sodium, potassium and water. Macrogol (3350) is unchanged along the gut. It is virtually unabsorbed from the gastrointestinal tract.
","Measure 25 ml of this oral solution with the measuring cup provided, then add this to 100 ml of water. Any unused diluted solution should be discarded within 24 hours.
Adult:
+
+- Constipation: 25 ml of this oral solution added to 100 ml of water once daily (to make a total volume of 125 ml). This may be increased to 2 - 3 doses of 25 ml daily (each 25 ml dose added to 100 ml of water), if required according to individual response.
+- Fecal Impaction: 8 doses of 25 ml daily (each 25 ml dose added to 100 ml of water). A course of treatment for fecal impaction does not normally exceed 3 days.
+
+Children (12-18 years): 25 ml of this oral solution added to 100 ml of water once daily.
",,"There is a possibility that the absorption of other medicinal products could be transiently reduced during use with this oral solution. There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics.
","Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory conditions of the intestinal tract, such as Crohn's disease and ulcerative colitis and toxic megacolon. Hypersensitivity to the active substances.
","In the treatment of chronic constipation, diarrhoea or loose stools normally respond to a reduction in dose. Diarrhoea, abdominal distension, anorectal discomfort and mild vomiting are more often observed during the treatment for fecal impaction. Vomiting may be resolved if the dose is reduced or delayed.
","Clinically, no effects during pregnancy are anticipated, since systemic exposure to Macrogol (3350) is negligible. This oral solution can be used during pregnancy. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to Macrogol (3350) is negligible. This oral solution can be used during breast-feeding.
","This medicinal product contains 8.125 mmol of sodium in each dose of 125 ml. The sodium content of this oral solution should be taken into consideration when administering the product to patients on a controlled sodium diet.
",,"Extensive fluid loss by diarrhea or vomiting may require correction of electrolyte disturbances.
",,,"Store below 30° C and in a place protected from light. Do not refrigerate.
",11
+2050,Macitentan,macitentan-2050,https://medex.com.bd/attachments/P8qEDfCtoA1QyJPyWjd4R4qFaWhqC4/macitentan-prescribing-information,Anti-hypertensive,Pulmonary arterial hypertension,"Macitentan is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I ) to reduce the risks of disease progression and hospitalization for PAH. Effectiveness was established in a long-term study in PAH patients with predominantly WHO Functional ... Read more
Macitentan is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I ) to reduce the risks of disease progression and hospitalization for PAH. Effectiveness was established in a long-term study in PAH patients with predominantly WHO Functional Class II-III symptoms treated for an average of 2 years. Patients had idiopathic and heritable PAH (57%), PAH caused by connective tissue disorders (31%), and PAH caused by congenital heart disease with repaired shunts (8%).
","Anti-hypertensive
","Endothelin (ET)-1 and its receptors (ETA and ETB ) mediate a variety of deleterious effects, such as vasoconstriction, fibrosis, proliferation, hypertrophy, and inflammation. In disease conditions such as PAH, the local ET system is upregulated and is involved in vascular hypertrophy and in organ damage. Macitentan is an endothelin receptor antagonist that inhibits the binding of ET-1 to both ETA and ETB receptors. Macitentan displays high affinity and sustained occupancy of the ET receptors in human pulmonary arterial smooth muscle cells. One of the metabolites of macitentan is also pharmacologically active at the ET receptors and is estimated to be about 20% as potent as the parent drug in vitro. The clinical impact of dual endothelin blockage is unknown.
","Recommended Dosage: The recommended dosage of Macitentan is 10 mg once daily for oral administration. Doses higher than 10 mg once daily have not been studied in patients with PAH and are not recommended.
Pregnancy Testing in Females of Reproductive Potential: Obtain a pregnancy test in females of reproductive potential prior to Macitentan treatment, monthly during treatment and one month after stopping Macitentan. Initiate treatment with Macitentan in females of reproductive potential only after a negative pregnancy test.
Pediatric Use: The safety and efficacy of Macitentan in children have not been established.
Geriatric Use: Of the total number of subjects in the clinical study of Macitentan for PAH, 14% were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
",,"Strong CYP3A4 Inducers: Strong inducers of CYP3A4 such as rifampin significantly reduce macitentan exposure. Concomitant use of Macitentan with strong CYP3A4 inducers should be avoided.
Strong CYP3A4 Inhibitors: Concomitant use of strong CYP3A4 inhibitors like ketoconazole approximately double macitentan exposure. Many HIV drugs like ritonavir are strong inhibitors of CYP3A4. Avoid concomitant use of Macitentan with strong CYP3A4 inhibitors. Use other PAH treatment options when strong CYP3A4 inhibitors are needed as part of HIV treatment
",,"The most common adverse reactions (more frequent than placebo by ≥3%) are anemia, nasopharyngitis/pharyngitis, bronchitis, headache, influenza, and urinary tract infection.
","Macitentan may cause fetal harm when administered to a pregnant woman. Macitentan is contraindicated in females who are pregnant. Macitentan was consistently shown to have teratogenic effects when administered to animals. If Macitentan is used during pregnancy, advise the patient of the potential risk to a fetus.
There are no data on the presence of Macitentan in human milk, the effects on the breastfed infant, or the effect on milk production. Because of the potential for serious adverse reactions in breastfed infants from Macitentan advise women not to breastfeed during treatment with Macitentan.
","
+- ERAs cause hepatotoxicity and liver failure. Obtain baseline liver enzymes and monitor as clinically indicated.
+- Fluid retention may require intervention.
+- Decreases in hemoglobin.
+- Pulmonary edema in patients with pulmonary veno-occlusive disease. If confirmed, discontinue treatment.
+- Decreases in sperm count have been observed in patients taking ERAs.
+
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+1811,Lyophilized Bacterial Lysate,lyophilized-bacterial-lysate-1811,,Other antibacterial preparation,Upper and lower respiratory tract infections,"Prevention of acute, sub-acute, chronic or recurrent infections of the upper respiratory tract (Common cold, Sinusitis, Pharyngitis, Epiglottitis, Laryngotracheitis, Otitis) and lower respiratory tract (Bronchitis, Bronchiolitis, Pneumonia, Acute Exacerbations in Chronic Obstructive Pulmonary Disease).
","Other antibacterial preparation
",,"Children 3 years and above, adults and elderly: One sublingual tablet daily, to be dissolved under the tongue before meal for 10 consecutive days per month, for three consecutive months.
",," Interactions with other drugs is not known.
","Hypersensivity to the active substance or auxiliary.
","In rare cases, respiratory, thoracic and mediastinal violations; skin and subcutaneous violations; general disorders, digestive disorders and local sublingual disturbances caused by the drug. In any case of violation, the treatment should be discontinued.
","Although toxic effects were observed in animals, not controlled studies were performed in pregnant women. For that reason, it is recommended to avoid the use during the first three months of confirmed or suspected pregnancy. During the period of fertility and lactation, special observations on the effect of the drug was carried out.
",,,"No cases of overdose were observed.
",,,"Store in a cool and dry place, protected from light.
",9
+705,Lynestrenol,lynestrenol-705,,Female Sex hormones,Oral contraceptives,"Lynestrenol is indicated in Polymenorrhoea, Menorrhagia and metrorrhagia, Selected cases of primary and secondary amenorrhoea and oligomenorrhoea, Premenstrual syndrome, Endometriosis, Selected cases of endometrial carcinoma, Benign breast disease, Suppression of menstruation ovulation and ovulation ... Read more
Lynestrenol is indicated in Polymenorrhoea, Menorrhagia and metrorrhagia, Selected cases of primary and secondary amenorrhoea and oligomenorrhoea, Premenstrual syndrome, Endometriosis, Selected cases of endometrial carcinoma, Benign breast disease, Suppression of menstruation ovulation and ovulation pain dysmenorrhoea, Postponement of menstruation, As an adjunct to estrogen therapy in pre-and postmenopause in order to avoid endometrial hyperplasia.
","Female Sex hormones, Oral Contraceptive preparations
","Lynestrenol is an oral preparation of the synthetic progestagen lynestrenol, which shares various activities with the natural hormone progesterone. Lynestrenol has a strong progestational influence on the endometrium. In addition, it suppresses ovulation and menstruation for as long as the preparation is taken daily without interruption. Lynestrenol can be used in conditions requiring a pronounced progestagenic effect. After oral administration lynestrenol is readily absorbed and subsequently converted into the pharmacologically active norethisterone, through which it exerts its major biological effects. Within 2-4 hours after ingestion of lynestrenol peak plasma levels of norethisterone are reached. Lynestrenol and its metabolites are predominantly excreted in the urine, and to a less extent in the faeces.
","Polymenorrhoea: 1 tablet daily on days 14-25 of the cycle.
Premenstrual syndrome: 1 tablet daily on days, 4-25 of the cycle.
Endometriosis: 1-2 tablets daily for at least 6 months.
Selected cases of endometrial carcinoma: 6-10 tablets daily for prolonged periods.
Benign breast disease: 1 tablet daily on days 14-25 of the cycle for at least 3-4 months.
Menorrhagia and metrorrhagia: 1 tablet daily on days 14-25 of the cycle cease within a few days after the start of the treatment. Treatment is repeated during the next 3 menstrual cycles with 1 tablet daily on days 14-25 of each cycle. Further diagnostic procedures are necessary if the complaints do not disappear during or after this treatment.
Selected cases of primary and secondary amenorrhoea and oligomenorrhoea: Treatment should start with the administration of an estrogen, e.g. 0.02-0.05 mg ethinylestradiol per day for 25 days. In conjunction with this, 1 tablet daily of Lynestrenol is administered on days 14-25. After cessation of treatment, a withdrawal bleeding usually occurs within 3 days. Treatment is resumed (second cycle) starting on day 5 of this withdrawal bleeding with the estrogen given on days 5-25 of the cycle and again with 1 tablet daily of Lynestrenol on days 14-25. This treatment should be repeated for at least another cycle.
Suppression of menstruation ovulation and ovulation pain dysmenorrhoea: Treatment with 1 tablet daily should start preferably on day 1, but no later than day 5 of the cycle The treatment can be continued for many months (without tablet-free days). If in spite of treatment, a breakthrough bleeding occurs, the dosage should be increased to 2 or 3 tablets daily for 3-5 days.
Postponement of menstruation: Treatment with 1 tablet daily should start preferably 2 weeks before the expected onset of menstruation. If treatment is started less than 1 week before the expected onset of menstruation the dosage should be 2-3 tablets per day. However, in that case a delay of more than 1 week is undesirable. The risk of breakthrough bleeding increases if treatment is started later. Therefore, treatment should not be started later than 3 days before the expected onset of menstruation.
As an adjunct to estrogen therapy in pre-and postmenopause in order to avoid endometrial hyperplasia: 1/2-1 tablet daily for 12-15 days per month, e.g. for the first 2 weeks of every calendar month; the estrogen may be administered daily without tablet-free intervals at the lowest effective dose.
","Lynestrenol tablets should be taken orally with some fluid.
","There are some indications, mainly obtained with other progestagen-containing preparations, that activated charcoal, barbiturates (primidone included), hydantoins and rifampicin may possibly decrease the effectiveness of Lynestrenol. Conversely, Lynestrenol may possibly increase the effectiveness of certain beta-adrenergic blockers and cyclosporin and possibly decrease the effectiveness of insulins.
","
+- Pregnancy or suspected pregnancy.
+- Severe liver disease such as cholestatic jaundice or hepatitis (or a history of severe liver disease if the results of liver function tests have failed to return to normal), hepatic cell tumours,Rotor syndrome and Dubin-Johnson syndrome.
+- Undiagnosed vaginal bleeding.
+- Conditions of rare occurrence known to be affected by sex steroids, or a history of these conditions (the condition may have occurred first or worsened during pregnancy or use of sex steroids); i.e. herpes gestationis, jaundice of pregnancy otosclerosis, severe pruritus or porphyria.
+
","During continuous treatment regimens with Lynestrenol, breakthrough bleeding or spotting will occur frequently (over 10 per cent) during the first two months. Later on the frequency gradually decreases. During cyclic treatment regimens breakthrough bleeding and spotting will be seen occasionally (1-10 per cent). Temporarily increasing the dose will control the bleeding in most cases. Other adverse events which occur frequently (over 10 per cent) are : change in libido (both increase and decrease), nausea or other gastrointestinal disturbances, and weight increase. Adverse events which may be observed occasionally (1-10 per cent) or rare (less than 1 per cent) are : headache or migraine, dizziness, nervousness, depression, increased sweating, acne, hirsutism, chloasma, rash, pruritus, jaundice, change in lipoprotein profile, alterations in liver function tests, amenorrhoea, menstrual irregularity, reduced glucose tolerance, breast pain, oedema. Most of these adverse events are transient and of minor importance in many cases.
","This medicine is contraindicated during pregnancy. There are insufficient data on the use of this medicine during breast feeding to assess potential harm.
","
+- Chloasma is occasionally seen during the use of estrogen and/or progestagen-containing preparations, especially in women with a history of chloasma gravidarum. In women with a tendency to chloasma exposure of the skin to natural or artificial sunlight may induce or aggravate the condition.
+- Occasionally changes in parameters of liver function, carbohydrate metabolism and haemostasis may occur. If the results of relevant tests become abnormal, treatment should be discontinued. An increase in LDL-cholesterol and a decrease in HDL-cholesterol may occur during Lynestrenol therapy.
+- During prolonged treatment with progestagens, periodic medical examinations are advisable.
+- As determined by the effects on SHBG, lynestrenol has weak androgenic activity. This is confirmed by the slight signs of virilisation (such as acne and hirsutism) observed in some patients.
+- Patients with any of the following conditions should be kept under close medical supervision: circulatory disorders (or a history of this condition), since with estrogen/progestagen containing oral contraceptive preparations a slightly increased risk of some cardiovascular disorders has been reported; some forms of severe depression,if likely to be exacerbated by sex steroid
+
",,,,,"Store in a cool & dry place, away from light. Keep the medicine out of the reach of children.
",11
+704,Lymecycline,lymecycline-704,https://medex.com.bd/attachments/RiZRFO0erQo98fWiqoPtxosc0NXldA/lymecycline-prescribing-information,Tetracycline group of drugs,Syphilis,"Lymecycline capsules belong to a group of medicines called tetracycline antibiotics. It is used to treat acne which appears as blackheads or whiteheads, which people often refer to as pimples or spots.
This medicine can also be used to treat other infections, such as:
+
+- Acute sinusitis
... Read more
Lymecycline capsules belong to a group of medicines called tetracycline antibiotics. It is used to treat acne which appears as blackheads or whiteheads, which people often refer to as pimples or spots.
This medicine can also be used to treat other infections, such as:
+
+- Acute sinusitis
+- Bronchitis
+- Infections in the abdomen
+- Some types of eye infections called trachoma
+- Soft skin infections
+
","Tetracycline group of drugs
","Lymecycline is a tetracycline derivative which blocks the access of bacterial aminoacyl-tRNA to the mRNA-ribosome complex by binding to the 30S ribosome subunit, preventing the addition of amino acids to the growing peptide chain in protein synthesis
","Adults and children over 12 years:
+
+- Acne: the normal dose is one capsule once a day, preferably in the morning. Lymecycline capsules should always be taken with a glass of water. How long you will have to take Lymecycline capsules for will depend on how quickly your condition improves. For acne this will normally be a minimum of eight weeks.
+- Infections: For other infections the usual dose is one Lymecycline capsule twice a day. Your doctor may recommend a higher or lower dose; this depends upon the type and severity of the infection. Ask your doctor if you are unsure. Lymecycline capsules should always be taken with a glass of water.
+
+
Use in children and adolescents: Lymecycline capsules are not recommended for use in children under 12 years of age as they can cause permanent discolouration of tooth enamel and affect bone development.
","Should be taken on an empty stomach. Take 1 hr before or 2 hr after meals.
","Decreased absorption with Ca, Al, Mg, bismuth and zinc salts, antacids, bismuth containing ulcer-healing drugs, Fe preparations and quinapril. Increased effects of anticoagulants. Decreased plasma levels with barbiturates, phenytoin or carbamazepine.
","Hypersensitivity to lymecycline or other tetracyclines. Overt renal insufficiency. Pregnancy and lactation. Concomitant use with methoxuflurane or oral retinoids.
","Lymecycline capsules may also cause the following
side effects.
Common (occur in less than 1 in 10 patients):
+
+- Feeling sick (nausea)
+- Abdominal pain
+- Diarrhoea
+- Headache
+
+Unknown (frequency cannot be estimated from
available information):
+
+- Eyesight disturbances
+- Dizziness
+- Being sick (vomiting)
+- Yellowing of eyes or skin (jaundice)
+- Increased sensitivity of the skin to sunlight (real or artificial)
+- Increased pressure in the brain
+- Changes in type or number of certain blood cells
+- Pain in the upper part of the abdomen
+- Changes in some blood tests (liver function tests)
+- Fever
+- Itchiness, skin rash, or hives
+- Inflammation of the intestine
+
","If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Lymecycline capsules must not to be taken if you are pregnant or breast feeding. Use of medicines such as Lymecycline capsules may affect the proper growth of developing teeth or bones, and lead to permanent tooth discolouration.
","Patient with myasthenia gravis. May exacerbate SLE. Hepatic impairment.
",,,,,"Store below 25° C. Protect from light.
",11
+703,Lurasidone Hydrochloride,lurasidone-hydrochloride-703,https://medex.com.bd/attachments/ZV6cFVbS8ST7tCRcSFvb6rPwYLi7I2/lurasidone-hydrochloride-prescribing-information,Atypical neuroleptic drugs,Schizophrenia,"Lurasidone Hydrochloride is an atypical antipsychotic. This is used for the treatment of: Schizophrenia, Depressive episodes associated with Bipolar I Disorder (bipolar depression), as monotherapy and as adjunctive therapy with lithium or valproate.
","Atypical neuroleptic drugs
","The efficacy of Lurasidone in schizophrenia could be mediated through a combination of central Dopamine D2 and Serotonin 5HT2A receptor antagonism.
","Schizophrenia-
+
+- Starting Dose: 40 mg once daily
+- Recommended Dose: 40 mg to 160 mg once daily
+
+Bipolar Depression-
+
+- Starting Dose: 20 mg once daily
+- Recommended Dose: 20 mg to 120 mg once daily
+
+Lurasidone should be taken with food. Administration with food substantially increases the absorption of Lurasidone.
",,"The Lurasidone dose should be reduced to half of the original level when used concomitantly with moderate inhibitors of CYP3A4 (e.g., Diltiazem, Atazanavir, Erythromycin, Fluconazole, Verapamil, etc.). If Lurasidone is used concomitantly with a moderate CYP3A4 inducer, it may be necessary to increase the Lurasidone dose.
Grapefruit: Grapefruit and grapefruit juice should be avoided in patients taking Lurasidone, since these may inhibit CYP3A4 and alter Lurasidone concentrations.
","Hypersensitivity. Concurrent administration of strong CYP3A4 inhibitors (eg, Ketoconazole). Concurrent administration of strong CYP3A4 inducers (eg, Rifampin). Dementia-related psychosis.
","Somnolence, akathisia, extrapyramidal symptoms, and nausea.
","Pregnancy Category B. Lurasidone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Patient should be advised not to breast-feed an infant if they are taking Lurasidone.
","Cerebrovascular adverse reactions in elderly patients with dementia-related psychosis: Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack).
Neuroleptic malignant syndrome: Manage with immediate discontinuation and close monitoring.
Tardive dyskinesia: Discontinue if clinically appropriate.
Metabolic changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain.
Hyperglycemia and diabetes mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes.
Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics.
Weight Gain: Gain in body weight has been observed. Monitor weight.
Hyperprolactinemia: Prolactin elevations may occur.
Leukopenia, neutropenia and agranulocytosis: Perform complete blood counts (CBC) in patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia or neutropenia. Consider discontinuing Lurasidone if a clinically significant decline in WBC occurs in the absence of other causative factors.
Orthostatic hypotension and syncope: Dizziness, tachycardia or bradycardia, and syncope may occur, especially early in treatment. In patients with known cardiovascularor cerebrovascular disease, and in antipsychotic-naïve patients, consider a lower starting dose and slower titration.
","Moderate and Severe Renal Impairment: Recommended starting dose is 20 mg per day, and the maximum recommended dose is 80 mg per day .
Moderate and Severe Hepatic Impairment: Recommended starting dose is 20 mg per day. The maximum recommended dose is 80 mg per day in moderate hepatic impairment and 40 mg per day in severe hepatic impairment.
",,,,"Protect from light and moisture, store below 30° C. Keep out of the reach of children.
",11
+1473,Luliconazole,luliconazole-1473,https://medex.com.bd/attachments/TEZz2VqWlqR4qeFb3nHS9CfKVecPGL/luliconazole-prescribing-information,Miscellaneous topical agents,Tinea corporis (ringworm),"Luliconazole is indicated for the topical treatment of interdigital
+
+- Tinea pedis (athelet's foot),
+- Tinea cruris, and
+- Tinea corporis.
+
","Miscellaneous topical agents
","Luliconazole is a topical antifungal agent. It is a broad-spectrum antifungal agent that belongs to the azole group. It acts against fungus by inhibiting the enzyme lanosterol demethylase and blocks ergosterol synthesis which is an important constituent of fungal cell membrane. Thus it exerts strong fungicidal activity both in-vitro and in-vivo against dermatophytes, Candida albicans, Malassezia spp, Trichophyton and Epidermophyton spp.
","Adult:
+
+- Interdigital tinea pedis: Luliconazole cream should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for two weeks.
+- Tinea cruris and Tinea corporis: Luliconazole cream should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for one week.
+
+Geriatric: Same as adult
Pediatric: Safety and effectiveness have not been established.
",,,"None
","Contact dermatitis and cellulitis may occur. Application site reactions were observed in iess than 1% of subjects in clinical trial.
","Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Luliconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether luliconazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Luliconazole cream is applied to women who are breastfeeding.
","If there is any unusual allergic reaction with the use of Luliconazole, then treatment should be discontinued and appropriate therapy should be instituted. Luliconazole is recommended for topical use only. It is not intended for ophthalmic, oral or intravaginal use.
",,,,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",9
+702,Lubiprostone,lubiprostone-702,https://medex.com.bd/attachments/bB3XwJKn2Tuo97VlRoCacWc1qZtYfG/lubiprostone-prescribing-information,Other laxative preparations,Irritable bowel syndrome (IBS),"Lubiprostone is indicated in:
+
+- Irritable Bowel Syndrome with Constipation (IBS-C).
+- Chronic Idiopathic Constipation (CIC) in adults.
+- Opioid-Induced Constipation (OIC) in adult patients with chronic, non-cancer pain.
+
","Other laxative preparations
","Lubiprostone is a locally-acting chloride-channel activator that increases intestinal secretion. In doing so, it increases intestinal motility, thus aiding the passage of stool and relieve the symptoms associated with chronic idiopathic constipation.
Lubiprostone acts by specifically activating ClC-2 chloride channels, which is a normal constituent of the apical membrane of the human intestine, in a protein kinase A action independent fashion. Activation of ClC-2 chloride channels causes an efflux of chloride ions into the lumen, which in turn leads to an efflux of sodium ions through a paracellular pathway to maintain isoelectric neutrality. As a result, water follows sodium into the lumen in order to maintain isotonic equilibrium, thereby increasing intestinal fluid secretion. By increasing intestinal fluid secretion, lubiprostone increases motility in the intestine, thereby increasing the passage of stool and alleviating symptoms associated with chronic idiopathic constipation. Activation of ClC-2 chloride channels may also stimulate the recovery of muscosal barrier function by restoring tight junction protein complexes in the intestine. Patch clamp cell studies in human cell lines have indicated that the majority of the beneficial biological activity of lubiprostone and its metabolites is observed only on the apical (luminal) portion of the gastrointestinal epithelium.
","Irritable Bowel Syndrome with Constipation: The recommended dose is 8 mcg twice daily orally with food and water.
Dosage in patients with hepatic impairment: Dosage adjustment is not required for patients with moderately impaired hepatic function. For patients with severely impaired hepatic function, the recommended starting dose is 8 mcg once daily. If tolerated then dose can be increased to 8 mcg twice
Chronic Idiopathic Constipation and Opioid-induced Constipation: The recommended dose is 24 mcg twice daily orally with food and water.
Dosage in patients with hepatic impairment: For patients with moderately impaired hepatic function, the recommended starting dose is 16 mcg twice daily. For patients with severely impaired hepatic function, the recommended starting dose is 8 mcg twice daily.
",,"There is a possibility of a dose-dependent decrease in the efficacy of Lubiprostone in patients using diphenylheptane opioids.
","Lubiprostone is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
","Diarrhea, full or bloated feeling or pressure in the stomach, nausea, stomach pain, swelling of abdominal or stomach area, Dyspnea
","Pregnancy category C. It is not known whether lubiprostone is excreted in human milk. Because lubiprostone increases fluid secretion in the intestine and intestinal motility, human milk-fed infants should be monitored for diarrhea. Caution should be exercised when Lubiprostone is administered to a nursing woman.
","Nausea: Patients taking Lubiprostone may experience nausea. Concomitant administration of food with Lubiprostone may reduce symptoms of nausea.
Diarrhea: Lubistone should not be prescribed to patients that have severe diarrhea.
Bowel Obstruction: In patients with symptoms suggestive of mechanical gastrointestinal obstruction, perform a thorough evaluation to confirm the absence of an obstruction prior to initiating therapy with Lubiprostone.
",,"Adverse reactions due to overdose may include: nausea, diarrhea, vomiting, dizziness, headache, abdominal pain, flushing/hot flash, retching, dyspnea, pallor, stomach discomfort, anorexia, asthenia , chest discomfort, dry mouth, hyperhidrosis , and syncope.
",,,"Store between 15-30° C.
",11
+730,Mercaptopurine,mercaptopurine-730,https://medex.com.bd/attachments/ZC6eqUxw80ZQaJr3FZvPT07jlAoMKJ/mercaptopurine-prescribing-information,Cytotoxic Chemotherapy,Leukemia,"Mercaptopurine is indicated for maintenance therapy of acute lymphatic (lymphocytic, lymphoblastic) leukemiaas part of a combination regimen. The response to this agent depends upon the particular subclassification of acute lymphatic leukemia and the age of the patient (pediatric ... Read more
Mercaptopurine is indicated for maintenance therapy of acute lymphatic (lymphocytic, lymphoblastic) leukemiaas part of a combination regimen. The response to this agent depends upon the particular subclassification of acute lymphatic leukemia and the age of the patient (pediatric or adult).
Mercaptopurine is not effective for prophylaxis or treatment of central nervous system leukemia. Mercaptopurine is not effective in acute myelogenous leukemia, chronic lymphatic leukemia, the lymphomas (including Hodgkins Disease), or solid tumors.
","Cytotoxic Chemotherapy
","Mercaptopurine is a purine antagonist which is converted intracellularly into its active nucleotides, including thioinosinic acid. The nucleotides inhibit several reactions which ultimately interferes with nucleic acid synthesis and prevents the formation of RNA and DNA.
","Crohn's disease:
+
+- Adult: Initially 1-1.5 mg/kg daily, may increase to 125 mg daily.
+- Child: Initially 1-1.5 mg/kg daily increased to a max of 75 mg daily
+
+Acute lymphocytic leukemia:
+
+- Adult: Usual maintenance dose: Initially, 1.5-2.5 mg/kg daily as a single dose, usually used in combination with methotrexate. Dose may vary individually based on response and tolerance. Monitor blood counts at least once wkly. Withdraw treatment immedietely if there is a sharp drop in the white cell count or severe bone-marrow depression. May resume treatment slowly and carefully if white cell count remains constant for 2-3 days or rises. Reduce dose when used with allopurinol.
+- Child: Usual maintenance dose: Initially, 1.5-2.5 mg/kg daily as a single dose, usually used in combination with methotrexate. Dose may vary individually based on response and tolerance. Monitor blood counts at least once wkly. Withdraw treatment immedietely if there is a sharp drop in the white cell count or severe bone-marrow depression. May resume treatment slowly and carefully if white cell count remains constant for 2-3 days or rises. Reduce dose when used with allopurinol.
+
","Should be taken on an empty stomach. Best taken on an empty stomach 1 hr before or 2 hr after meals. Ensure adequate fluid intake.
","Anticoagulant action of warfarin may be inhibited by mercaptopurine. Enhanced toxicity with myelosuppressive drugs.
","Pregnancy and lactation. Prior resistance to mercaptopurine or thioguanine; severe liver disease; severe bone marrow suppression.
","Hyperuricaemia, bone marrow toxicity, hypoplasia, anorexia, diarrhoea, leukopenia, thrombocytopenia, intestinal ulceration, crystalluria with haematuria, immunosuppression, interstitial pneumonitis. Cutaneous hyperpigmentation, alopecia.
","Pregnancy category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Hepatic or renal dysfunction; monitor hepatic function periodically. Mercaptopurine is potentially carcinogenic. Thiopurine S-methyl transferase (TPMT) deficiency; porphyria.
","Renal Impairment: Dosage may need to be reduced.
Hepatic Impairment:
+
+- Crohn's disease: Dosage may need to be reduced.
+- Acute lymphocytic leukemia: Dosage may need to be reduced
+
+Dosage adjustment in patients with thiopurine-S-methyl transferase (TPMT) deficiency to prevent life-threatening myelotoxicity.
For patients with homozygous TPMT deficiency: Substantial reduction is required.
For patients with heterozygous TPMT deficiency: Some may require reduction but most will tolerate the usual dosages.
",,,,"Store at 20-25° C
",12
+1855,Mepyramine Maleate,mepyramine-maleate-1855,https://medex.com.bd/attachments/TSXQRxEZkHUold9FGzc2QMOk2coOPI/mepyramine-maleate-prescribing-information,Miscellaneous topical agents,Insect bites,"Mepyramine Maleate Cream is a type of antihistamine used for the relief of insect bites, stings and nettle rash. Mepyramine Maleate Cream works by relieving the pain, itching and inflammation from insect bites, stings and nettle rash. Your doctor or pharmacist, however, may recommend Anthisan Cream for another purpose.
","Miscellaneous topical agents
",,"Apply Mepyramine Maleate Cream directly to the site of the insect bite or sting or nettle rash, two to three times a day. For best results, use as soon as possible after the bite. sting or appearance of nettle rash. Use for up to three days.
",,,,,,,,,,,"Keep the medicine in a cool, dry place where the temperature stays below 25°C. Do not store Anthisan Cream or any other medicine in the bathroom or near a sink. Do not leave it on a windowsill or in the car. Heat and damp can destroy some medicines.
",4
+448,Menthol + Thymol + Eucalyptol + Methyl Salicylate,menthol-thymol-eucalyptol-methyl-salicylate-448,,Oral preparations,Teeth cleaner & brighter,"Bad breath, Cavities, Gingivitis, Gum disease, Oral hygiene, Plaque, Teeth cleaner & brighter
","Oral preparations
","This preparation is a clinically proven antiseptic mouthwash that provides you complete care for healthier mouth with around-the-clock protection against bacteria and plaque. Your mouth stays cleaner, fresher and healthier.
+
+- 24 hours protection against plaque, gingivitis and gum disease
+- Fights against germs that cause bad breath
+- Kills germs between teeth and keeps teeth cleaner & brighter
+
","Rinse with 20 ml Antiseptic Mouthwash for 30 seconds, twice daily (morning and evening). Then rinse with water. Do not swallow. Not indicated below 12 years of age.
",,"There are no known drug interactions and none well documented.
","Hypersensitivity
","Do not rinse, eat, or smoke for thirty minutes after using a mouthwash. Doing so will diminish the effects of the mouthwash.
","Pregnancy Category - Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
","Do not swallow. It is not indicated below 12 years of age. Keep out of the reach of children. Keep in a cool and dry palace. Do not use if cap seal is broken.
",,,,,,9
+1263,Menthol + Pramoxine Hydrochloride,menthol-pramoxine-hydrochloride-1263,,Topical Analgesics,Skin irritations,"Pain and Itching: For temporary relief of pain and itch associated with minor skin irritations, minor cuts, minor burns, minor sunburns, scrapes, or insect bites; may also be used for rashes due to poison ivy, oak, or sumac.
","Local Antipruritic, Topical Analgesics
","Menthol primarily activates the cold-sensitive TRPM8 receptors in the skin. Menthol, after topical application, causes a feeling of coolness due to stimulation of 'cold' receptors by inhibiting Ca++ currents of neuronal membranes. It may also yield analgesic properties via kappa-opioid receptor agonism.
Pramocaine reversibly binds and inhibits voltage gated sodium channels on neurons decreasing sodium permeability into the cell. This stabilizes the membrane and prevents ionic fluctuations needed for depolarization stopping any action potential propagation.
Menthol and pramoxine: Each of these agents elicits local anesthetic effects.
","Adult: Apply topically to affected area up to 3-4 times daily.
Child:
+
+- <2 years: Safety and efficacy not established
+- >2 years: Apply topically to affected area up to 3-4 times daily
+
",,"There are no known drug interactions and none well documented.
","Hypersensitivity, Deep or puncture wounds, animals bites, serious burns, large areas of the body
","Redness, irritation, swelling or pain.
","Pregnancy Category A. Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
","For external use only. Avoid contact with eyes Do not use in the eyes or mucous membranes Not for prolonged use Do not apply to large areas of the body. Discontinue if symptoms persist for >7 days or clear up and occur again within a few days. Discontinue if redness, irritation, swelling, or pain persists or increases
",,,,,,9
+728,Meningococcal Polysaccharide Vaccine,meningococcal-polysaccharide-vaccine-728,https://medex.com.bd/attachments/f6JsYUURGBWc5QB9HrZyqdKm2RjvLR/meningococcal-polysaccharide-vaccine-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Septic arthritis,"Meningococcal Polysaccharide Vaccine is indicated for the active immunization of children from 2 years of age, adolescents and adults against meningococcal disease caused by meningococci of serogroups A, C, W135 and Y. The vaccine may also be used for:
+
+- Subjects who are living in closed communities and close contacts of patients with disease caused by meningococci of serogroups A, C, W135 and Y.
+- Travellers to countries where the disease is epidemic or highly endemic
+
","Vaccines, Anti-sera & Immunoglobulin
","Meningococcal Polysaccharide Vaccine is a freeze-dried preparation of the group-specific polysaccharide antigens from Neisseria meningitidis Group A, Group C, Group Y and Group W135. When reconstituted, the vaccine is a clear, colorless sterile solution for subcutaneous use.
","The immunizing dose is a single injection of 0.5 ml administered subcutaneously. Primary Immunization For both adults and children from 2 years of age, vaccine is administered subcutaneously as a single 0.5 ml dose. Protective antibody levels may be achieved within 7 to 10 days after vaccination.
",,,"Hypersensitivity to the active substances or to any of the excipients.
","Meningococcal polysaccharide vaccine is generally well tolerated. Adverse reactions usually occur within 48 hours following vaccination.
Metabolism and nutrition disorders-
+
+- Common: appetite lost Psychiatric disorders:
+- Very common: irritability
+
+Nervous system disorders-
+
+- Very common: drowsiness, headache.
+- Uncommon: dizziness
+
+Gastrointestinal disorders-
+
+- Common: gastrointestinal symptoms e.g. nausea, vomiting and diarrhea
+
+Musculoskeletal and connective tissue disorders-
+
+General disorders and administration site conditions-
+
+- Very common: pain and redness at the injection site, fatigue
+- Common: swelling at the injection site, fever
+
","Pregnancy: Adequate human data on use during pregnancy and adequate animal reproduction studies are not available. This vaccine should be used during pregnancy only when clearly needed and when the possible advantages outweigh the possible risks for the fetus.
Lactation: Adequate data on the administration of this vaccine to women who are breast-feeding are not available. This vaccine should be administered to women who are breast-feeding when needed and the possible advantages outweigh the possible risks.
","As with other vaccines, the administration of Meningococcal polysaccharide vaccine should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contraindication for immunization. This vaccine gives no protection against meningococcal meningitis caused by meningococci belonging to serogroups other than A, C, W135 and Y. If administered to subjects with impaired immune responses, the vaccine may not induce an effective response.As with all injectable vaccines, appropriate medication (e.g. adrenaline) should always be readily available for treatment in case of anaphylactic reactions following the administration of the vaccine. Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.
",,,,,"Keep out of the reach and sight of children .Store and transport at 2°C to 8°C. Do not freeze Protect from light .The vaccine should be used within 30 minutes after reconstitution
",9
+1799,Meningococcal Conjugate Vaccine,meningococcal-conjugate-vaccine-1799,https://medex.com.bd/attachments/DkohZIlkpzzZBfKvp7jDHSJmJDEg1u/meningococcal-conjugate-vaccine-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Meningococcal infection,"Meningococcal Conjugate Vaccine is indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal diseases caused by Neisseria meningitidis group A, C, W-135, and Y.
","Vaccines, Anti-sera & Immunoglobulin
","Anti-capsular meningococcal antibodies protect against meningococcal diseases via complement mediated bactericidal activity. Meningococcal Conjugate Vaccine induces the production of bactericidal antibodies against capsular polysaccharides of Neisseria meningitidis group A,C,W-135 and Y when measured by assays using either rSBA or hSBA.
","Posology: Meningococcal Conjugate Vaccine should be used in accordance with available official recommendations. Primary immunisation:
+
+- Infants from 6 weeks to less than 6 months of age: two doses, each of 0.5 ml, should be administered with an interval of 2 months between doses.
+- Infants from 6 months of age, children, adolescents and adults: a single 0.5 mL doseshould be administered.
+- An additional primary dose of Meningococcal Conjugate Vaccine may be considered appropriate for some individuals.
+
+
Booster doses: After completion of the primary immunisation course in infants 6 weeks to less than 12 months of age, a booster dose should be given at 12 months of age with an interval of at least 2 months after the last Meningococcal Conjugate vaccination. In previously vaccinated individuals 12 months of age and older, Meningococcal Conjugate Vaccine may be given as a booster dose if they have received primary vaccination with a conjugated or plain polysaccharide meningococcal vaccine.
","Immunisation should be carried out by intramuscular injection only. In infants, the recommended injection site is the anterolateral aspect of the thigh. In individuals from 1 year of age, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle. For instructions on reconstitution of the medicinal product before administration.
","
+- In infants, Meningococcal Conjugate Vaccine can be given concomitantly with combined DTaP-HBV-IPV/Hib vaccines and with 10-valent pneumococcal conjugate vaccine.
+- From age 1 year and above, Meningococcal Conjugate Vaccine can be given concomitantly with any of the following vaccines: hepatitis A (HAV) and hepatitis B (HBV) vaccines, measles- mumps-rubella (MMR) vaccine, measles- mumps- rubella- varicella (MMRV) vaccine, 10-valent pneumococcal conjugate vaccine or unadjuvanted seasonal influenza vaccine.
+- In the second year of life, Meningococcal Conjugate Vaccine can also be given concomitantly with combined diphtheria- tetanus- acellular pertussis (DTaP) vaccines, including combination DTaP vaccines with hepatitis B, inactivated poliovirus or Haemophilus influenzae type b (HBV, IPV or Hib) such as DTaP-HBV-IPV/Hib vaccine, and 13-valent pneumococcal conjugate vaccine.
+- In individuals aged 9 to 25 years, Meningococcal Conjugate Vaccine can be given concomitantly with human papillomavirus bivalent [Type 16 and 18] vaccine, recombinant (HPV2).
+- Whenever possible, Meningococcal Conjugate Vaccine and a TT containing vaccine, such as DTaP-HBV-IPV/Hib vaccine, should be co-administered or Meningococcal Conjugate Vaccine should be administered at least one month before the TT containing vaccine.
+- One month after co-administration with a 10-valent pneumococcal conjugate vaccine, lower Geometric Mean antibody Concentrations (GMCs) and opsonophagocytic assay (OPA) antibody GMTs were observed for one pneumococcal serotype (18C conjugated to tetanus toxoid carrier protein). The clinical relevance of this observation is unknown.
+- There was no impact of co-administration on immune responses to the other nine pneumococcal serotypes.
+- One month after co-administration with a combined tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Tdap) in subjects aged 9 to 25 years, lower GMCs were observed to each pertussis antigen (pertussis toxoid [PT], filamentous haemagglutinin [FHA] and pertactin [PRN]). More than 98% of subjects had anti-PT, FHA or PRN concentrations above the assay cut-off thresholds. The clinical relevance of these observations is unknown. There was no impact of co-administration on immune responses to Meningococcal Conjugate Vaccine or the tetanus or diphtheria antigens included in Tdap.
+- If Meningococcal Conjugate Vaccine is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites.
+- It may be expected that in patients receiving immunosuppressive treatment, an adequate response may not be elicited.
+
","Hypersensitivity to the active substances or to any of the excipients of this preparation.
","Adverse reactions are Appetite lost, Irritability, Insomnia, Crying, Drowsiness, Headache, Hypoaesthesia, Dizziness, Diarrhoea, Vomiting, Nausea, Pruritus, Rash, Myalgia, Pain in extremity, Fever, Swelling at injection site, Pain at injection site, Redness at injection site, Fatigue, Injection site haematoma, Malaise, Injection site induration, Injection site pruritus, Injection site warmth, Injection site anaesthesia
","Pregnancy: There is limited experience with use of Meningococcal Conjugate Vaccine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development. Meningococcal Conjugate Vaccine should be used during pregnancy only when clearly needed, and the possible advantages outweigh the potential risks for the foetus.
Breast-feeding: It is unknown whether Meningococcal Conjugate Vaccine is excreted in human milk. Meningococcal Conjugate Vaccine should only be used during breast-feeding when the possible advantages outweigh the potential risks.
",,,"No case of overdose has been reported.
",,,"Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original package in order to protect from light.
",11
+1868,Menaquinone-7,menaquinone-7-1868,,Drugs for Osteoarthritis,Rheumatoid arthritis,"This capsule is indicated for the treatment and prevention of-
+
+- Osteoporosis
+- Coronary artery calcification
+- Rheumatoid arthritis
+
","Drugs for Osteoarthritis
","Menaquinone-7 is a fat soluble vitamin which is also known as vitamin K2. Menaquinone-7 is an especial key isomer of vitamin K2 that is produced using Bacillus subtilis. Menaquinone-7 is the active trans-isomer of natural vitamin K2 with the highest bioavailability and longest half-life in blood. This makes Menaquinone-7 also available for tissues outside the liver, namely bones, arteries and soft tissues. It is a powerful cofactor in transporting excess calcium out of the arteries and depositing it into the bones thus prevents hardening of arteries. Menaquinone-7 is very essential for healthy bone and artery.
","Orally 1-2 capsules daily or as advised by the physician.
",,"Menaquinone-7 may alter the effect of warfarin. Concomitant use with orlistat may decrease the absorption of Menaquinone-7.
","Contraindicated in patients with known hypersensitivity to Menaquinone-7. Use of Menaquinone-7 is contraindicated with warfarin.
","Generally well tolerated in recommended dose. From a large number of clinical trials using dosages in excess of 40 mg/day, there were no reports of side effects associated with any type of hypercoagulable state.
","Menaquinone-7 can be used during pregnancy. Use of Menaquinone-7 during pregnancy may help both mother and child in formation and maintaining proper bone health.
",,,,,,"Store at temperature below 30˚C, protect from light & moisture. Keep out of reach of children.
",9
+727,Memantine Hydrochloride,memantine-hydrochloride-727,https://medex.com.bd/attachments/GR42zyVGucLAS3ifJ3lZKp8lMbcfzg/memantine-hydrochloride-prescribing-information,,Mild to moderate dementia in Alzheimer’s disease,"Memantine is indicated for the treatment of all froms of dementia of the Alzheimer's type. Memantine may also be indicated in other types of dementia.
",,"Persistent activation of N-methyl-D-aspartate (NMDA) receptors in Central Nervous System by the excitatory amino acid glutamate has been hypothesized to contribute to the symptomatology of Alzheimer's disease. Memantine is postulated to exert its therapeutic effect through its action as a low to moderate affinity as an uncompetitive (open-channel) NMDA receptor antagonist which binds preferentially to the NMDA receptor-operated cation channels.
Memantine is well absorbed after oral administration and has linear pharmacokinetics over the therapeutic dose range. It is excreted predominantly unchanged in the urine and has a terminal elimination half-life of about 60-80 hours. Following oral administration, Memantine is highly absorbed with peak concentrtions reached in about 3-7 hours. Food has no effect on the absorption of Memantine. The mean volume of distribution of Memantine is 9-11 L/kg and the plasma protein binding is low (45%). emantine undergoes partial hepatic metabolism. About 48% of administered drug is excreted unchanged in urine; the remainder is converted primarily to three polar metabolites which possess minimal NMDA receptor antagonistic activity: the N-glucuronide conjugate, 6-hydroxy Memantine and 1-nitroso-deaminated Memantine. A total of 74% of the administered dose is excreted as the sum of the parent drug and the N-glucuronide conjugate. The hepatic microsomal CYP-450 enzyme system does not play a significant role in the metabolism of Memantine.
","The recommended maintenance dose of Memantine for adults and older patients is 20 mg every day. In order to lower the risk of side effects, the dose should be achieved by upward titration with 5 mg per week over 3 weeks, achieving the maintenance dose of 20 mg/day from the start of week 4 according to the following dosage guideline:
Week 1 (Everyday): Morning- 5 mg (1 tablet), Night- No dose
Week 2 (Everyday): Morning- 5 mg (1 tablet), Night- 5 mg (1 tablet)
Week 3 (Everyday): Morning- 10 mg (2 tablets), Night- 5 mg (1 tablet)
Week 4 and onwards (Everyday): Morning- 10 mg (2 tablets), Night- 10 mg (2 tablets)
Missed Dose: If any dose is missed, just wait and take the next dose at the usual time. Do not double the dose to compensate for the missed dose.
In case renal impairment: In patients with moderate renal impairment (creatinine clearance 30-49 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two downward strokes). If tolerated well after at least 7 days of treatment, the dose could be increased up to 20 mg/day according to standard titration scheme. In patients with severe renal impairment (creatinine clearance 5-29 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two downward strokes) per day.
In case of hepatic impairment: In patients with mild or moderate hepatic impaired function, no dosage adjustment is needed. Administration of memantine is not recommended in patients with severe hepatic impairment.
Children under 18 years: Memantine is not recommended for use in children below 18 years due to lack of data on safety and efficacy.
",,"Due to the pharmacological effects and mechanism of action of memantine suggests that the effects of L-dopa, dopaminergic agonists, and anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists such as memantine. The effects of barbiturates and neuroleptics may be reduced. Concomitant administration of mematine with the antispasmodic agents, dantrolene or baclofen, can modify their effects and a dosage adjustment may be necessary. Memantine should not be used with amantadine, ketamine, dextromethorphan, phenytoin, cimetidine, ranitidine, procainamide, quinidine, quinidine, quinine & nicotine.
","Memantine Hydrochloride is contraindicated in patients with known hypersensitivity to Memantine Hydrochloride or to any excipients used in the formulation.
","Most frequent side effects (frequency of 2% or less) include hallucination, confusion, dizziness, headache and fatigue. Occasional side effects include anxiety, hypertonus (heightened muscle tension), vomiting, bladder infections and increased sexual drive. If there is a history of epileptic seizures, there is a slight chance that Memantine may increase the probability of an attack.
","Pregnancy Category B. Yet there are no adequate and well controlled studies of Memantine in pregnant women. Memantine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Memantine is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when Memantine is administered to a nursing mother.
","Caregivers should be instructed in the recommended administration (twice per day for doses above 5 mg) and dose escalation (minimum interval of one week between dose increases). If the patients suffer from kidney dysfunction, the kidney function should be monitored at regular basis.
Seizures: Memantine has not been systematically evaluated in patients with a seizure disorder. One clinical trial shows that seizures occurred in 0.2% of patients treated with Memantine and 0.5% of patients treated with placebo.
Carcinogenesis, Mutagenesis and Impairment of Fertility: Study shows that no risk of carcinogenesis, mutagenesis and impairment of fertility are caused after Memantine use.
Operating Vehicles or Machinery: Taking Memantine may alter the reaction time significantly; therefore safe driving and safe operation of machinery may no longer be possible.
",,,,,"Store in a cool and dry place, protected from light. Keep this medication out of reach of children.
",9
+1658,Memantine + Donepezil,memantine-donepezil-1658,https://medex.com.bd/attachments/4x3NvphxGahWhmxB0wrWaxZMEWCr7s/memantine-donepezil-prescribing-information,Anti-Alzheimer drugs,Alzheimer’s disease,"Memantine and donepezil hydrochlorides extended-release capsules are a combination of memantine hydrochloride, an NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor, indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.
","Anti-Alzheimer drugs
","Memantine and donepezil hydrochlorides extended-release capsules contain two approved medications: memantine hydrochloride extended-release and donepezil hydrochloride. Each of those medications is postulated to have a different mechanism in Alzheimer’s disease.
Memantine: Persistent activation of central nervous system NMDA receptors by the excitatory amino acid glutamate has been hypothesized to contribute to the symptomatology of Alzheimer’s disease. Memantine is postulated to exert its therapeutic effect through its action as a low to moderate affinity uncompetitive (open channel) NMDA receptor antagonist which binds preferentially to the NMDA receptor-operated cation channels. There is no evidence that memantine prevents or slows neurodegeneration in patients with Alzheimer’s disease.
Donepezil: Current theories on the pathogenesis of the cognitive signs and symptoms of Alzheimer’s disease attribute some of them to a deficiency of cholinergic neurotransmission. Donepezil is postulated to exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine in the central nervous system through reversible inhibition of its hydrolysis by acetylcholinesterase. There is no evidence that donepezil prevents or slows neurodegeneration in patients with Alzheimer’s disease.
","For patients on donepezil hydrochloride 10 mg only, the recommended starting dose of memantine and donepezil hydrochlorides extended-release capsules is 7 mg/10 mg, taken once daily in the evening. The dose should be increased in 7 mg increments to the recommended maintenance dose of 28 mg/10 mg. The minimum recommended interval between dose increases is one week.
Patients on memantine hydrochloride (10 mg twice daily or 28 mg extended-release once daily) and donepezil hydrochloride 10 mg once daily can be switched to memantine and donepezil hydrochlorides extended- release capsules 28 mg/10 mg, taken once daily in the evening.
Memantine and donepezil hydrochlorides extended- release capsules can be taken with or without food, whole or sprinkled on applesauce; do not divide, chew, or crush. Severe renal impairment: the recommended maintenance dose for memantine and donepezil hydrochlorides extended-release capsules is 14 mg/10 mg once daily in the evening.
",,"Combined use with NMDA antagonists: use with caution. Memantine and donepezil hydrochlorides extended-release may interfere with anticholinergic medications. Concomitant administration of succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists may lead to synergistic effect.
","Memantine and donepezil hydrochlorides extended-release capsules are contraindicated in patients with known hypersensitivity to memantine hydrochloride, donepezil hydrochloride, piperidine derivatives, or to any excipients used in the formulation.
","The most common adverse reactions, occurring at a frequency of at least 5% and greater than placebo with memantine hydrochloride extended-release 28 mg/day, were headache, diarrhea, and dizziness. The most common adverse reactions occurring at a frequency of at least 5% in patients receiving donepezil and at twice or more the placebo rate, include diarrhea, anorexia, vomiting, nausea, and ecchymosis.
","There are no adequate data on the developmental risk associated with the use of memantine and donepezil hydrochlorides extended-release capsules or its active ingredients (memantine hydrochloride and donepezil hydrochloride) in pregnant women. There are no data on the presence of memantine or donepezil in human milk, the effects on the breastfed infant, or the effects of memantine and donepezil hydrochlorides extended-release capsules or its metabolites on milk production.
","
+- Memantine and donepezil hydrochlorides extended-release is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia.
+- Memantine and donepezil hydrochlorides extended-release may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block.
+- Monitor patients for symptoms of active or occult gastrointestinal bleeding, especially those at increased risk for developing ulcers.
+- Memantine and donepezil hydrochlorides extended-release can cause diarrhea, nausea, and vomiting.
+- Memantine and donepezil hydrochlorides extended-release may cause bladder outflow obstructions.
+- Conditions that raise urine pH may decrease the urinary elimination of memantine, resulting in increased plasma levels of memantine.
+
","Pediatric Use: Safety and effectiveness of memantine and donepezil hydrochlorides extended-release in pediatric patients have not been established.
Renal Impairment: No dosage adjustment is needed in patients with mild or moderate renal impairment.
Hepatic Impairment: No dosage adjustment is needed in patients with mild or moderate hepatic impairment. Memantine and donepezil hydrochlorides extended-release has not been studied in patients with severe hepatic impairment
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+726,Meloxicam,meloxicam-726,https://medex.com.bd/attachments/cZaSfTY4lvFKoglDMj2vXSWtrKqox9/meloxicam-prescribing-information,Drugs for Osteoarthritis,Spondylitis,"Meloxicam is indicated in-
+
+- Osteoarthritis,
+- Rheumatoid arthritis,
+- Ankylosing spondylitis
+
","Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam family, with anti-inflammatory, analgesic and antipyretic properties. The bioavailability of Meloxicam following oral administration is 89% on the average. With the doses of 7.5 mg & 15 mg plasma concentrations are proportional to dose: 0.4 to 1.0 mg/litre for 7.5 mg & 0.8 to 2.0 mg/litre for 15 mg, on an average. Meloxicam is very strongly bound to plasma proteins, essentially albumin (99%). Meloxicam is extensively metabolised, chiefly by oxidation of the methyl redical attached to the thiazolyl ring. Elimination in unchanged form accounts for 3% of the dose. Half of the substance is eliminated in urine & the other half in the faeces. The mean elimination half life is 20 hours.
","For Adults:
+
+- Osteoarthritis: 7.5 mg/day. If necessary, in the absence of improvement, the dose may be increased to 15 mg/day.
+- Rheumatoid arthritis: 15 mg/day. In elderly patients the recommended dose for long term treatment is 7.5 mg/day.
+- Ankylosing spondylitis: 15 mg/day. In elderly patients the recommended dose is 7.5 mg/day.
+
+Do not exceed the dose of 15 mg/day. The total daily amount should be taken as a single dose. Patients with increased risks for adverse reactions should start treatment with 7.5 mg/day. In dialysis patients with severe renal failure the dose should not exceed 7.5 mg/day
For Children: The pharmacokinetics of Meloxicam in paediatric patients under 18 years of age have not been investigated.
",,"
+- Other NSAIDs, including high doses of salicylates: Administration of several NSAIDs together may increase the risk of ulcers and of gastrointestinal bleeding, via a synergistic effect.
+- Oral anticoagulants, heparin and ticlopidine: Increased risk of bleeding via inhibition of platelet function and damage to the gastroduodenal mucosa. Careful monitoring of the effects of anticoagulants is thus essential if it proves impossible to avoid such combined prescription.
+- Lithium: NSAIDs increase blood lithium levels, which may then reach toxic values.
+- Methotrexate: NSAIDs may accentuate the haematologic toxicity of methotrexate.
+- Intrauterine contraceptive devices: NSAIDs appear to decrease the efficacy of intrauterine contraceptive devices.
+
","Meloxicam is contraindicated to patients hypersensitive to this drug. Meloxicam should not be given to patients who have developed signs of asthma, nasal polyps, angioneurotic oedema or urticaria following the administration of aspirin or NSAIDs. Meloxicam is contraindicated to patients with active peptic ulcer during the last six months or a history of recurrent peptic ulcer disease, severe hepatic failure, non-dialysed severe renal failure, gastrointestinal bleeding, cerebrovascular bleeding or other bleeding disorders.
","Nausea, vomiting, abdominal pain, dyspepsia, constipation or diarrhoea may occur. Ulcers or gastrointestinal bleeding may rarely occur. Skin rash, or urticaria may occur in some individuals. Oedema of the lower limbs may occur during treatment. Onset of an asthma attack has been reported in certain individuals allergic to aspirin or to other NSAIDs. Headache, vertigo or drowsiness may occur.
","It is advisable to avoid the administration of Meloxicam during pregnancy. It is unknown whether Meloxicam passes into mother’s milk. Meloxicam should not be given to nursing mothers.
","Patient with known CV disease or risk factors for CV disease, fluid retention or heart failure, history of GI bleeding or ulceration. Hepatic and renal impairment. Elderly. Pregnancy and lactation.
",,,,,"Store Meloxicam tablet in a cool & dry place and away from light. Store Meloxicam suppository below 25˚C protected from light and moisture.
",10
+725,Melatonin,melatonin-725,https://medex.com.bd/attachments/9yAwCqWXfiY4RX9svmZyd53aA31D5a/melatonin-prescribing-information,Oral nutritional preparations,Osteoporosis,"Melatonin is used for numerous conditions but is showing the most promise in the short-term regulation of sleep patterns, including jet lag.
Insomnia: Melatonin helps to induce sleep in people with-
+
+- Disrupted circadian rhythms (such as those suffering from jet lag or poor vision or those who work the night shift)
... Read more
Melatonin is used for numerous conditions but is showing the most promise in the short-term regulation of sleep patterns, including jet lag.
Insomnia: Melatonin helps to induce sleep in people with-
+
+- Disrupted circadian rhythms (such as those suffering from jet lag or poor vision or those who work the night shift)
+- Low melatonin levels (such as some elderly and individuals with schizophrenia)
+- Children with learning disabilities who suffer from insomnia.
+
+
Osteoporosis: Melatonin stimulates cells called osteoblasts that promote bone growth.
In Menopause: Melatonin helps peri- or postmenopausal women to regulate sleep patterns.
Eating disorders: Melatonin levels may play a role in the symptoms of anorexia.
Attention Deficit Hyperactivity Disorder (ADHD): it may be effective in managing sleep disturbances in children with this condition. And
Sarcoidosis ","Hormone preparations for other uses, Oral nutritional preparations
","After administration, melatonin binds with its receptors. Two types of melatonin receptor subtypes - MT1 & MT2 have been identified in humans. Melatonin receptors are found in the brain and some peripheral organs. The MT1 subtype is present in the pars tuberalis of the pituitary gland and the suprachiasmatic nuclei of the hypothalamus. The MT2 subtype is mainly present in the retina. Increased level of Melatonin initiates neural & endocrine signals to optimize the levels of neurotransmitters e.g. increased serotonin, increased GABA & decreased dopamine, which induces & sustains sleep, as well as, maintains the body's circadian rhythm.
","Adult:
Insomnia: 3-6 mg one hour before bedtime
Jet lag:
+
+- 0.50 to 5 mg one hour prior to bedtime at final destination or, 1 to 5 mg 1 hour before bedtime for 2 days prior to departure and for 2 to 3 days upon arrival at final destination.
+- Eastbound travel- Take a preflight early evening treatment followed by treatment at bedtime for 4 days after arrival.
+- Westbound travel- Take for 4 days at bedtime when in the new time zone.
+
+Sarcoidosis: 20 mg per day for 4 to 12 months.
Depression: 0.125 mg twice in the late afternoon, each dose 4 hours apart.
Difficulty falling asleep: 5 mg 3 to 4 hours before an imposed sleep period over a 4-weeks period.
Children (6 months to 14 years of age): For sleep disorders 0.30 mg/day
",,"Antidepressant Medications: Melatonin reduces the antidepressant effects of desipramine and fluoxetine. In addition, fluoxetine leads to measurable depletion of melatonin in people.
Antipsychotic Medications: People with schizophrenia and tardive dyskinesia taking antipsychotic medications with melatonin has significantly reduced mouth movements compared to those who did not take the supplements.
Benzodiazepines: The combination of melatonin and triazolam improves sleep quality. In addition, there have been a few reports suggesting that melatonin supplements may help individuals stop using long-term benzodiazepine therapy.
Blood Pressure Medications: Melatonin may reduce the effectiveness of blood pressure medications like methoxamine and clonidine. In addition, calcium channel blockers (such as nifedipine, verapamil, diltiazem, amlodipine, nimodipine, felodipine, nisoldipine, and bepridil) may decrease melatonin levels. The use of beta-blockers (propranolol, acebutolol, atenolol, labetalol, metoprolol, pindolol, nadolol, sotalol, and timolol) may reduce melatonin production in the body.
Blood-Thinning Medications, Anticoagulants: Melatonin may increase the risk of bleeding from anticoagulant medications such as warfarin.
Interleukin-2: In one study of 80 cancer patients, the use of melatonin in conjunction with interleukin-2 led to more tumor regression and better survival rates than treatment with interleukin-2 alone.
Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs such as ibuprofen may reduce the levels of melatonin in the blood.
Steroids and Immunosuppressant Medications: People should not take melatonin with corticosteroids or other medications used to suppress the immune system because the supplement may cause them to be ineffective.
Tamoxifen: Preliminary research suggests that the combination of tamoxifen (a chemotherapy drug) and melatonin may benefit certain patients with breast and other cancers.
Other Substances: Caffeine, tobacco, and alcohol can all diminish levels of melatonin in the body while cocaine and amphetamines may increase melatonin production.
","Melatonin should not be used by patients who have autoimmune diseases.
","Possible adverse effects include headache and depression. Drowsiness may be experienced within 30 minutes after taking melatonin and may persist for 1 hour and thus may affect driving skills.
","Information regarding safety and efficacy in pregnancy and lactation is not available.
","Caffeine and fluvoxamine may increase the effects of melatonin, while melatonin may decrease the antihypertensive effect of nifedipine.
",,"There is little or no evidence of any major toxicities with melatonin,even at high doses.
",,,"Store below 30°C. Keep away from light. Keep all the medicine out of reach of children.
",11
+724,Megestrol Acetate,megestrol-acetate-724,https://medex.com.bd/attachments/5IIdP4rJW3mNWEIPEW8gMCWE9yuSB2/megestrol-acetate-prescribing-information,,,"Megestrol Tablet is indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (i.e., recurrent, inoperable, or metastatic disease). It should not be used instead of currently accepted procedures such as surgery, radiation, or chemotherapy.
Megestrol Oral Suspension ... Read more
Megestrol Tablet is indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (i.e., recurrent, inoperable, or metastatic disease). It should not be used instead of currently accepted procedures such as surgery, radiation, or chemotherapy.
Megestrol Oral Suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of Acquired Immunodeficiency Syndrome (AIDS) & cancer.
",,"Megestrol Acetate is a synthetic, antineoplastic and progestational drug. While the precise mechanism by which Megestrol Acetate produces its antineoplastic effects against endometrial carcinoma is unknown at the present time, inhibition of pituitary gonadotrophin production and resultant decrease in estrogen secretion may be factors. The antineoplastic action of megestrol acetate on carcinoma of the breast is effected by modifying the action of other steroid hormones and by exerting a direct cytotoxic effect on tumor cells. In metastatic cancer, hormone receptors may be present in some tissues but not others. The receptor mechanism is a cyclic process whereby estrogen produced by the ovaries enters the target cell, forms a complex with cytoplasmic receptor and is transported into the cell nucleus. There it induces gene transcription and leads to the alteration of normal cell functions. Pharmacologic doses of megestrol acetate not only decrease the number of hormone-dependent human breast cancer cells but also are capable of modifying and abolishing the stimulatory effects of estrogen on these cells.
Estimates of plasma levels of Megestrol Acetate are dependent on the measurement method used. Peak plasma concentrations occur 2 to 3 hours after a single oral dose 160 mg tablets. The plasma half-life of Megestrol Acetate is 33 to 38 hours. Approximately 66% of an administered dose is excreted in the urine and approximately 20% in the faeces.
","Tablet:
+
+- Breast cancer: 160 mg/day
+- Endometrial carcinoma: 40-320 mg/day in divided doses.
+- At least 2 months of continuous treatment is considered an adequate period for determining the efficacy of Megestrol.
+
+
Oral Suspension: The recommended adult initial dosage of Megestrol Oral Suspension is 800 mg/day (20 ml/day).
",,"Pharmacokinetic studies show that there are no significant alterations in pharmacokinetics parameters of Zidovudine or Rifabutin to warrant dosage adjustment when Megestrol Acetate is administered with these drugs. The effects of Zidovudine or Rifabutin on the pharmacokinetics of Megestrol Acetate were not studied.
","History of hypersensitivity to Megestrol Acetate or any component of the formulation. Known or suspected pregnancy.
","Weight Gain: Weight gain is a frequent side effect of Megestrol Acetate. This gain has been associated with increased appetite and is not necessarily associated with fluid retention.
Thromboembolic Phenomena: Thromboembolic phenomena including thrombophlebitis and pulmonary embolism (in some cases fatal) have been reported.
Glucocorticoid Effects: The glucocorticoid activity of Megestrol Acetate has not been fully evaluated. Clinical cases of new onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, and overt Cushing’s syndrome have been reported in association with the chronic use of Megestrol Acetate. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic Megestrol Acetate therapy in the stressed and non-stressed state.
Other: Nausea, dyspnea, tumor flare, hyperglycemia, glucose intolerance, alopecia, hypertension, carpal tunnel syndrome, mood changes, hot flashes, malaise, asthenia, lethargy, sweating and rash.
","Pregnancy Category D. The use of progestational agents during the first four months of pregnancy is not recommended. Very small amounts (approximately 0.1%) are excreted in mother's milk. It is however, not known whether these amounts exert any harmful effect on the newborn. Because of the potential for adverse effects on the new born, nursing should be discontinued during treatment with Megestrol Acetate.
","General: Close surveillance is indicated for any patient treated for recurrent or metastatic cancer. Use with caution in patients with a history of thromboembolic disease.
Use in Diabetics: Exacerbation of preexisting diabetes with increased insulin requirements has been reported in association with the use of Megestrol Acetate.
","Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: In the dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
","No serious unexpected side effects have resulted from studies involving Megestrol Acetate administered in dosages as high as 1600 mg/day.
",,,"Store at or below 25°C. Protect from heat, light & moisture.
",11
+723,Mefloquine,mefloquine-723,https://medex.com.bd/attachments/JZLehGLP0caXLfBD0qeU8gxnEANj0m/mefloquine-prescribing-information,Anti-malarial drugs,Malaria,"Mefloquine is indicated in-
+
+- Acute Malaria Infections caused by Mefloquine-susceptible strains of Plasmodium falciparum (both chloroquine- susceptible and resistant strains) or by P. vivax
+- Prophylaxis of P. falciparum and P. vivax malaria infections
+
","Anti-malarial drugs
","Mefloquine has been found to produce swelling of the Plasmodium falciparum food vacuoles. It may act by forming toxic complexes with free heme that damage membranes and interact with other plasmodial components.
Mefloquine is an antimalarial agent which acts as a blood schizonticide. Mefloquine is active against the erythrocytic stages of Plasmodium species. However, the drug has no effect against the exoerythrocytic (hepatic) stages of the parasite. Mefloquine is effective against malaria parasites resistant to chloroquine. Mefloquine is a chiral molecule. According to some research, the (+) enantiomer is more effective in treating malaria, and the (-) enantiomer specifically binds to adenosine receptors in the central nervous system, which may explain some of its psychotropic effects.
","Adult:
+
+- Malaria prevention: 1 tablet (250 mg) once per week starting 1-2 weeks before departure and continued for 4 weeks after leaving malarious area.
+- Malaria treatment: 5 tablets (5X250 mg) in a single dose (up to max. 1.5 gm) or preferably in 2 divided doses 6 to 8 hours apart.
+
+In Children 6 Months and Older:
+
+- Malaria prevention: Approximately 5 mg/kg body weight once per week (250 mg for children weighing over 45 kg, decreasing in proportion to body weight for children weighing 45 kg or less).
+- Malaria treatment: 20 to 25 mg/kg body weight which may be split into two doses 6 to 8 hours apart to reduce the occurrence or severity of adverse reactions.
+
+
Geriatric Use: Experiences have not identified differences in responses between the elderly and younger patients.
Should be taken with food. Best taken with meals & a full glass of water.
",,"Increased risk of ECG abnormalities with quinine or chloroquine, antihistamines, TCAs and phenothiazines. May increase risk of seizure with quinidine or quinine. Concomitant use with valproic acid, phenobarbital, carbamazepine and phenytoin may cause loss of seizure control and lower plasma levels of anticonvulsants. Increased risk of QT prolongation and arrhythmia with ketoconazole. Concomitant use with digoxin, Ca channel blockers, antiarrhythmics and β-blockers may increase the risk of cardiotoxicity. Increased risk of ventricular arrhythmias with amiodarone. Concomitant use with TCAs, SSRIs, buprion, antipsychotic, tramadol may increase the risk of convulsions. Increased plasma levels with metoclopromide. May compromise adequate immunisation by live typhoid vaccine. Vaccinations with attenuated live bacteria should be completed at least 3 days prior the 1st dose of mefloquine.
","Use of Mefloquine is contraindicated in patients with a known hypersensitivity to Mefloquine or related compounds (e.g. quinine and quinidine). It should not be prescribed for prophylaxis in patients with active depression, a recent history of depression, generalized anxiety disorder, psychosis, or schizophrenia or other major psychiatric disorders, or with a history of convulsions.
","Among subjects who received Mefloquine for prophylaxis of malaria, following side effects was observed:
+
+- The most frequently observed sied-effects were vomiting, dizziness, syncope, extrasystoles and other complaints affecting less than 1%. Among subjects who received Mefloquine for treatment, following side-effects was observed:
+- The most frequently observed side-effects included : dizziness, myalgia, nausea, fever, headache, vomiting, chills, diarrhoea, skin rash, abdominal pain fatigue, loss of appetite, and tinnitus
+
","Use in Pregnancy: There is no adequate and well-controlled study in pregnant women. However, clinical experience with Mefloquine has not revealed an embrytoxic or teratogenic effect. Mefloquine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in Nursing Mothers: Mefloquine is excreted in breast milk in small amounts. the activity of which is unknown. Because of the potential for serious adverse reactions in nursing infants form Mefloquine. a decision should be made whether to discontinue the drug taking into account the importance of the drug to the mother.
","Warnings: Mefloquine may cause psychiatric symptoms in a number of patients, ranging from anxiety, paranoia, and depression to hallucinations and psychotic behavior. Rare cases of suicidal ideation and suicide have been reported though no relationship to drug administration has been confirmed. Mefloquine should be used with caution in patients with a previous history of depression. Concomitant administration of Mefloquine and quinine or quinidine may produce electrocardiographic abnormalities and may increase risk of convulsions.
Precautions: In patients with epilepsy, Mefloquine may increase the risk of convulsions. Caution should be exercised with regard to activities requiring alertness and fine motor coordination such as driving, piloting aircraft and operating machinery. Mefloquine should be used with caution in patients with psychiatric disturbances. In patients with impaired liver function the elimination of Mefloquine may be prolonged, leading to higher plasma levels.
",,"In cases of overdosage with Mefloquine, the symptoms may be more pronounced. The following procedure is recommended in case of overdosage:
+
+- Induce vomiting or perform gastric lavage, as appropriate.
+- Monitor cardiac function (if possible by ECG), neurologic and psychiatric status for at least 24 hours.
+- Provide Symptomatic and intensive supportive treatment as required, particularly of cardiovascular disturbance.
+- Treat vomiting or diarrhoea with standard fluid therapy.
+
",,,"Store in a cool dry place. Protect from light.
",11
+721,Mefenamic acid,mefenamic-acid-721,https://medex.com.bd/attachments/cmuZX21LqJ7kzSHEwVdpPMFuSbBZnq/mefenamic-acid-prescribing-information,Drugs for Osteoarthritis,Rheumatoid arthritis,"Mefenamic Acid is indicated for-
+
+- Fever
+- Toothache
+- Headache
+- Migraine
+- Primary dysmenorrhoea
+- Menorrhagia
+- Mild to moderate pain in rheumatoid arthritis and osteoarthritis
+- Traumatic pain
+- Low-back pain
+- Juvenile chronic arthritis in children etc.
+
","Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Mefenamic acid contains Mefenamic Acid which is a nonsteroidal agent with demonstrated analgesic, anti-inflammatory and antipyretic activity due to its dual action on prostaglandins. It inhibits the enzymes of prostaglandin synthetase and also antagonizes the actions of prostaglandin at the receptor sites.
","Adult:
+
+- 500 mg dose should be given to adults upto three times (1.5 gm total) per day with meals. The dosage may be reduced to 1 tablet (250 mg) three times daily.
+- In case of menorrhagia: 500 mg three times daily with meals and from the onset of menses and continued according to the judgement of the physician.
+
+
Children:
+
+- 6 months to 1 year: 5 ml three times/day.
+- 2-4 years: 10 ml three times/day.
+- 5-8 years: 10 ml four times /day.
+- 9-12 years: 15 ml four times/day.
+
+Treatment should not be continued for more than 7 days except on the advice of a physician.
",,"Aspirin: As other NSAIDs, concomitant administration of Mefenamic Acid and Aspirin is not generally recommended because of the potential of increased adverse effects.
Warfarin: Mefenamic Acid can inhibit platelet aggregation and may prolong the prothrombin time in patients on warfarin therapy
","It is contraindicated in patients with known hypersensitivity to Mefenamic Acid. It should not be used in patients with peptic ulcer, inflammatory bowel diseases, hepatic or renal impairment. It is also contraindicated in patients, whom aspirin and/or other NSAID's have induced symptoms of bronchospasm, skin rashes etc.
","The most frequently reported adverse experiences occurring in approximately 1-10% of patients are gastrointestinal: abdominal pain, constipation, diarrhoea, dyspepsia, flatulence, nausea, Gl ulcers, vomiting, dizziness, abnormal renal function, pruritus, rashes.
","The safety of Mefenamic acid on reproductive capacity and pregnancy has not been established. Thus, mefenamic acid should be used in women of childbearing potential and during pregnancy only when the potential benefits are expected to outweigh the potential risks. Trace amounts of Mefenamic acid may be present in breast milk and transmitted to the nursing infant. Thus Mefenamic acid should not be taken by the nursing mother because of the effects of this class of drugs on the infant's cardiovascular system.
","It should be administered with caution in allergic diseases especially in asthma. The treatment should be withdrawn in diarrhoea, rashes, cholestatic jaundice, thrombocytopenia, haemolytic anaemia.
",,,,,"Keep away from light, store in a cool and dry place. Keep out of reach of children.
",10
+1835,Medroxyprogesterone Acetate (Tablet),medroxyprogesterone-acetate-tablet-1835,https://medex.com.bd/attachments/05zl7bmlq8xhgMDHNOysgMCvBK2l65/medroxyprogesterone-acetate-tablet-prescribing-information,Female Sex hormones,Uterine bleeding,"Medroxyprogesterone acetate tablet is a progestin indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. Medroxyprogesterone acetate is also indicated to reduce the incidence ... Read more
Medroxyprogesterone acetate tablet is a progestin indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. Medroxyprogesterone acetate is also indicated to reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving daily oral conjugated estrogens 0.625 mg tablets.
","Female Sex hormones
","Medroxyprogesterone acetate (MPA) administered orally or parenterally in the recommended doses to women with adequate endogenous estrogen, transforms proliferative into secretory endometrium. Androgenic and anabolic effects have been noted, but the drug is apparently devoid of significant estrogenic activity. While parenterally administered MPA inhibits gonadotropin production, which in turn prevents follicular maturation and ovulation, available data indicate that this does not occur when the usually recommended oral dosage is given as single daily doses.
","Secondary Amenorrhea: Medroxyprogesterone acetate tablets may be given in dosages of 5 or 10 mg daily for 5 to 10 days. A dose for inducing an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen is 10 mg of this tablet daily for 10 days. In cases of secondary amenorrhea, therapy may be started at any time. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing this tablet therapy.
Abnormal Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology: Beginning on the calculated 16th or 21st day of the menstrual cycle, 5 or 10 mg of this tablet may be given daily for 5 to 10 days. To produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen, 10 mg of this tablet daily for 10 days beginning on the 16th day of the cycle is suggested. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing therapy with this tablet. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with this tablet.
Reduction of Endometrial Hyperplasia in Postmenopausal Women Receiving Daily 0.625 mg Conjugated Estrogens: When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (for example, 3 to 6 month intervals) to determine if treatment is still necessary. For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
Medroxyprogesterone acetate tablet tablets may be given in dosages of 5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16th day of the cycle. Patients should be started at the lowest dose. The lowest effective dose of this tablet has not been determined.
",,,"Medroxyprogesterone Acetate is contraindicated in women with any of the following conditions:
+
+- Undiagnosed abnormal genital bleeding.
+- Known, suspected, or history of breast cancer.
+- Known or suspected estrogen- or progesterone-dependent neoplasia.
+- Active DVT, PE, or a history of these conditions
+- Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions.
+- Known anaphylactic reaction or angioedema to Medroxyprogesterone Acetate
+- Known liver impairment or disease.
+- Known or suspected pregnancy.
+
","The following adverse reactions have been reported in women taking Medroxyprogesterone Acetate tablets, without concomitant estrogens treatment:
+
+- Genitourinary system: Abnormal uterine bleeding (irregular, increase, decrease), change in menstrual flow, breakthrough bleeding, spotting, amenorrhea, changes in cervical erosion and cervical secretions.
+- Breasts: Breast tenderness, mastodynia or galactorrhea has been reported.
+- Cardiovascular: Thromboembolic disorders including thrombophlebitis and pulmonary embolism have been reported.
+- Gastrointestinal: Nausea, cholestatic jaundice.
+- Skin: Sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash have occurred. Acne, alopecia and hirsutism have been reported.
+- Eyes: Neuro-ocular lesions, for example, retinal thrombosis, and optic neuritis.
+- Central nervous system: Mental depression, insomnia, somnolence, dizziness, headache, nervousness.
+
","Medroxyprogesterone Acetate should not be used during pregnancy. There may be increased risks for hypospadias, clitoral enlargement and labial fusion in children whose mothers are exposed to Medroxyprogesterone Acetate during the first trimester of pregnancy. However, a clear association between these conditions with use of this tablet has not been established. This tablet should not be used during lactation. Detectable amounts of progestin have been identified in the breast milk of nursing mothers receiving progestins.
","Addition of a progestin when a woman has not had a hysterectomy: Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone. Endometrial hyperplasia may be a precursor to endometrial cancer. There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include an increased risk of breast cancer.
Unexpected abnormal vaginal bleeding: In cases of unexpected abnormal vaginal bleeding, adequate diagnostic measures are indicated.
Elevated blood pressure: Blood pressure should be monitored at regular intervals with estrogen plus progestin therapy.
Hypertriglyceridemia: In women with pre-existing hypertriglyceridemia, estrogen plus progestin therapy may be associated with elevations of plasma triglycerides leading to pancreatitis. Consider discontinuation of treatment if pancreatitis occurs.
Hepatic Impairment and/or past history of cholestatic jaundice: Estrogens plus progestins may be poorly metabolized in women with impaired liver function. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, medication should be discontinued.
Fluid Retention: Progestins may cause some degree of fluid retention. Women who have conditions which might be influenced by this factor, such as cardiac or renal impairment, warrant careful observation when estrogen plus progestin are prescribed.
Hypocalcemia: Estrogen plus progestin therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur.
Exacerbation of other conditions: Estrogen plus progestin therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
","Pediatric Use: Medroxyprogesterone Acetate tablets are not indicated in children. Clinical studies have not been conducted in the pediatric population.
Geriatric Use: There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Medroxyprogesterone Acetate alone to determine whether those over 65 years of age differ from younger subjects in their response to Medroxyprogesterone Acetate alone.
","Overdosage of estrogen plus progestin therapy may cause nausea and vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of CE plus MPA together with institution of appropriate symptomatic care.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+720,Medroxyprogesterone Acetate (Injection),medroxyprogesterone-acetate-injection-720,https://medex.com.bd/attachments/zHWePM6pfaap8P4wnGnjLFWrtr4lYr/medroxyprogesterone-acetate-injection-prescribing-information,Female Sex hormones,Uterine bleeding,"Medroxyprogesterone Acetate indicated for:
+
+- Ovulation suppression
+- The treatment of endometriosis.
+- Adjunctive and/or pallivative treatment of recurrent and/or metastatic endometrial or renal carcinoma.
+- The treatment of hormonally-dependant recurrent breast cancer in post-menopausal women.
+
","Female Sex hormones
","Pharmacodynamics: Medroxyprogesterone Acetate injection has prolonged progestational effects when administered by intramuscular injection. This injection suppresses the secretion of pituitary gonadotropins which, in turns, prevents follicular maturation producing long-term anovulation in the reproductive aged women. Medroxyprogesterone Acetate injection suppresses the Leydig cell function in the male. i.e. suppresses endogenous testosterone product.
Pharmacokinetics: Parenteral Medroxyprogesterone Acetate is a long acting progestational steroid. The 150 mg/ml formulation reaches half its initial concentration in about 27 days. Its long duration of acting results from its slow absorption from the injection site. The principle metabolite of medroxyprogesterone acetate that has been identified is a 6-alpha-methyl-6 beta 17 alpha, 21 trihydroxy-4-pregnene-3, 20-dione-17 acetate which is excreted in the urine.
","Ovulation suppression: Medroxyprogesterone Acetate injectables suspension should be gently shaken just before use to ensure that the dose being administered represents a uniform suspension. The recommended dose is 150 mg/ml of this injectable suspension every three months administered by intramuscular injection in the gluteal or deltoid muscle. The initial injection should be given during the first 5 days after the onset of a menstrual period; within the 5 days post partum if not breast feeding; if exclusively breast-feeding at or after six weeks post partum.
Based on limited experience, some investigators favour the use of a second injection of Medroxyprogesterone Acetate before 90 days to control troublesome bleeding. The third and subsequent injections should be administered at separate 90 days intervals.
If abnormal bleeding persists, appropriate investigations should be instituted to rule out the possibility of organic pathology. Uterine curettage may be required on rare occations.
",,"Aminoglutethimide administered concomitantly with high doses of medroxyprogestrone acetate may significant depress the serum concentration of medroxyprogestrone acetate. User should be warned of the possibility of decreases efficacy with the use of amoniglutethimide.
","Known or suspected pregnancy, Undiagnosed vaginal bleeding, Known or suspected malignancy of breast ( when used for ovulation suppression or gynaecology indications), Severe liver dysfunction, Known hypersensitivity to medroxyprogesterone acetate or any component of the drug.
","
+- Weight gain, feeling heaviness and pain in the abdomen, feeling pain, anxiety
+- Amenorrhea
+- Spotting
+- Excessive bleeding
+- Infection in the injected site
+- Headache, Blurring of vision
+- Pain in the back of the leg
+- Delay in pregnancy after withdrawing injectable contraceptive.
+
","Not recommended for the first 4 months.
","Unexpected vaginal bleeding during therapy, patient with a pre-existing medical condition that might be adversely affected by fluid retention, patients with a history of treatment for clinical depression diabetic patient. It may decrease the level of the following endocrine biomarkers: Plasma /urinary steroid (eg: cortisol, oestrogen, pregnanediol , progesterone & testosterone ) Plasma /urinary gonadotrophin (eg: LH & FSH) & sex hormonebinding- globulin (SHBG)
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+719,Mecobalamin,mecobalamin-719,https://medex.com.bd/attachments/hjEtbFDa968hT1pWc00nDv84EcCfzU/mecobalamin-tablet-capsule-prescribing-information,Drugs for Megaloblastic Anemia,Peripheral neuropathy,"Mecobalamin is indicated in-
+
+- Peripheral Neuropathies
+- Diabetic Neuropathy
+- Verteberal Syndrome
+- Nerve Compression Syndrome
+- Multiple sclerosis
+- Amyotrophic lateral sclerosis
+- Parkinson’s disease
+- Alzheimer’s disease
... Read more
Mecobalamin is indicated in-
+
+- Peripheral Neuropathies
+- Diabetic Neuropathy
+- Verteberal Syndrome
+- Nerve Compression Syndrome
+- Multiple sclerosis
+- Amyotrophic lateral sclerosis
+- Parkinson’s disease
+- Alzheimer’s disease
+- Diabetic retinopathy
+- Entrapment neuropathy
+- Drug induced neuropathy
+- Megaloblastic anemia due to Vitamin B12 deficiency
+
","Drugs for Megaloblastic Anemia
","Mecobalamin is the neurologically active form of vitamin B12 and occurs as a water-soluble vitamin in the body. It is a cofactor in the enzyme methionine synthase, which functions to transfer methyl groups for the regeneration of methionine from homocysteine. In anaemia, it increases erythrocyte production by promoting nucleic acid synthesis in the bone marrow and by promoting maturation and division of erythrocytes.
","Tablet: The usual adult dosage is 500 mcg tablet three times daily. The dosage should be adjusted according to the age of patient and the severity of symptoms.
Injection:
+
+- Peripheral neuropathies: The usual adult dosage is 500 mcg Mecobalamin administered intramuscularly or intravenously three times a week.The dosage should be adjusted according to the age of patient and the severity of symptoms.
+- Megaloblastic anemia: The usual adult dosage is 500 mcg Mecobalamin administered intramuscularly or intravenously three times a week. After about two months of administration, dosage should be changed to one ampoule equivalent to 500 mcg of Mecobalamin every one to three months as maintenance therapy
+
",,"Decreased GI tract absorption with neomycin, aminosalicylic acid, H2-blockers and colchicine. Reduced serum concentrations with oral contraceptives. Reduced effects in anaemia with parenteral chloramphenicol.
","Hypersensitivity to any component of this product.
","Generally Mecobalamin is well tolerated. However, a few side effects like GI discomfort (including anorexia, nausea or diarrhea) & rash may be seen after administration of Mecobalamin.
","Not recommended during pregnancy & lactation.
","The medicine should not be used for months if there is no response at all after its use for a certain period of time.
","Use in children: Not recommended.
",,,,"Oral: Store at room temperature. Protect from moisture and light.
Parenteral: Store at room temperature. Do not expose to direct light.
",11
+717,Meclizine Hydrochloride,meclizine-hydrochloride-717,https://medex.com.bd/attachments/jUjvaJq45KKiNrwocVqjnvYN5zmvPB/meclizine-hydrochloride-prescribing-information,Anti-emetic drugs,Vertigo,"Meclizine Hydrochloride is indicated in nausea, vomiting, motion sickness, vertigo.
","Anti-emetic drugs
","Meclizine has antiemetic, anticholinergic and antihistaminic properties. It reduces the sensitivity of the labyrinthine apparatus. The action may be mediated through nerve pathways to the vomiting center (VC) from the chemoreceptor trigger zone (CTZ), peripheral nerve pathways, the VC, or other CNS centers. Meclizine has an onset of action of 30 to 60 minutes, depending on dosage; their duration of action is 12 to 24 hours.
","Adult & children over 12 years of age:
+
+- Nausea and vomiting: 25-50 mg once daily.
+- Motion sickness: Take an initial dose of 25 to 50 mg, 1 hour prior to travel. May repeat dose every 24 hours for the duration of the journey. Children: Age 6-12 years, 12.5 mg once daily. Age 2-6 years, 6.25 mg once daily.
+- Vertigo: 25 to 100 mg daily in divided doses.
+- Radiotherapy induced nausea and vomiting: 50 mg two to twelve hours prior to radiotherapy.
+- Emergency contraception: 25-50 mg, 1 hour before first ECP dose; repeat if needed in 24 hours.
+
+
Use in children: Clinical studies establishing safety and efficacy in children have not been done; therefore, its use should be determined by physician.
Use in elderly: There is no specific information available. However older people may be especially sensitive to the anticholinergic effects of medicine.
",,"Meclizine may increase the toxicity with CNS depressants, neuroleptics and anticholinergic. Alcohol, sedatives and tranquilizers can increase the drowsiness of the patient.
","Meclizine is contraindicated in patients hypersensitive to Meclizine or any of its excipeints.
","Common side effects are Drowsiness, dry mouth, and on rare occasions, blurred vision have been reported.
","Meclizine shows no risk of birth defects or abnormalities when administered during pregnancy. Although Meclizine may excrete into the milk, it causes no harm in nursing babies.
","Patients with asthma, bronchitis, emphysema, enlarged prostate, glaucoma or urinary tract blockage should take Meclizine (like other antiemetics) with caution.
",,"Symptoms: Extreme excitability, seizures, drowsiness and hallucinations.
Treatment: Appropriate supportive and symptomatic treatment. Consider dialysis.
",,,"Store in a cool & dry place and away from children.
",11
+718,Meclizine + Pyridoxine,meclizine-pyridoxine-718,,Anti-emetic drugs,Pregnancy-associated nausea and vomiting,"Prevention and treatment of nausea, vomiting, dizziness, motion sickness, radiation sickness and vertigo associated with diseases of the vestibular system (e.g. Meniere's syndrome, labyrinthitis and other vestibular disturbances).
","Anti-emetic drugs
","Meclizine is a piperazine-derivative antihistamine that is used as an antiemetic. It has antiemetic, anticholinergic and antihistaminic properties. It reduces the sensitivity of the labyrinthine apparatus. The action may be mediated through nerve pathways to the vomiting center (VC) from the chemoreceptor trigger zone (CTZ), peripheral nerve pathways, the VC, or other CNS centers. Pyridoxine is vitamin B-6. It has been added to enhance the anti-emetic effects & as a dietary suppliment.
","Adult and Children 12 years of age & over:
+
+- Nausea and vomiting: 25-50 mg daily or as directed by a physician.
+- Motion sickness: Take an initial dose of 25-50 mg, 1 hour prior to travel. May repeat the dose every 24 hours for the duration of the journey.
+- Radiation sickness: 50 mg administered 2-12 hours prior to radiation treatment.
+- Vertigo: 25-100 mg daily in divided doses.
+- Prevention of nausea and vomiting associated with emergency contraceptive pill (ECP): 25-50 mg, 1 hour before first ECP dose; repeat if needed in 24 hours.
+
+The safety and efficacy for use in children less than 12 years of age have not been established.
",,"The CNS depressant effects of Meclizine can be potentiated by concurrent use of Ethanol or other CNS depressant agents such as Benzodiazepines, Barbiturates, Tricyclic antidepressants, opiate agonists, skeletal muscle relaxants and antihistamines. Concurrent use of other anticholinergics can potentiate the anticholinergic effects of Meclizine. Meclizine can increase the absorption of digoxin by decreasing gastrointestinal motility.
","Meclizine Hydrochloride and Pyridoxine Hydrochloride is contraindicated in patients who are hypersensitive to these ingredients.
","Drowsiness, dry mouth and, on rare occasions, blurred vision have been reported.
","Pregnancy Category B. Large-scale human studies have not demonstrated adverse fetal effects. It has been suggested that based on available data, Meclizine presents the lowest risk of teratogenicity and is the drug of first choice in treating nausea and vomiting during pregnancy. Safety for use in the nursing mother has not been established.
","Patients should be warned that Meclizine Hydrochloride may impair their ability to perform hazardous activities requiring mental alertness or physical coordination (e.g., operating machinery, driving a motor vehicle). Patients should avoid alcoholic beverages while taking this drug. Due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma or enlargement of the prostate gland.
",,"Symptoms: Extreme excitability, seizures, drowsiness and hallucinations.
Treatment: Appropriate supportive and symptomatic treatment. Consider dialysis
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+716,Mebhydrolin Napadisylate,mebhydrolin-napadisylate-716,,Sedating Anti-histamine,Vasomotor rhinitis,"Mebhydrolin Napadisylate is indicated in-
+
+- Allergic disease or symptoms such as urticaria
+- Pruritus of various origin
+- Eczema
+- Itching
+- Drug rash
+- Insect bites
+- Allergic conjunctivitis
+- Dermatitis of nutritional origin
+- Hay fever,
+- Vasomotor rhinitis
+- Allergic asthma.
+
","Sedating Anti-histamine
","Mebhydrolin diminishes or abolishes the main actions of histamine in the body by blocking of histamine receptors.
","Adults and children over 10 years: 2-6 tablets daily
Children-
+
+- 5-10 years: 2-4 tablets daily
+- 2-5 years: 1-3 tablets daily
+- Up to 2 years: 1-2 tablets daily
+
+Treatment should be given in several single doses daily. Mebhydrolin may be swallowed during or shortly after meals. For children, the tablet may be crushed and mixed with food.
",,"The effects of atropine and tricyclic anti-depressants may be enhanced by Mebhydrolin. It may mask the warning symptoms of damage caused by ototoxic drugs.
","
+- Hypersensitivity to any of the ingredients of Mebhydrolin tablet or to mebhydrolin
+- Prostatic hypertrophy, narrow-angle glaucoma.
+- First trimester of pregnancy.
+
","Lassitude, dizziness, hypotension, muscular weakness, nausea, vomiting, diarrhoea or constipation, epigastric pain, headache, blurred vision, tinnitus, depression, nightmares, anorexia, dryness of the mouth, tightness of the chest, tingling, sedation, drowsiness etc. may occur.
","Safety in pregnancy and lactation has not been established.
","The substance may cause drowsiness, if affected, driving or operating machinery & alcoholic drinks should be avoided.
","Safety in pregnancy and lactation has not been established.
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+749,Metolazone,metolazone-749,https://medex.com.bd/attachments/7h0sf153f8EfQ0UbY3BpffrowqWY4J/metolazone-prescribing-information,Thiazide diuretics & related drugs,Oedema,"Metolazone is indicated for the treatment of salt and water retention including:
+
+- Edema accompanying congestive heart failure
+- Edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function.
+
+Metolazone is also indicated
... Read moreMetolazone is indicated for the treatment of salt and water retention including:
+
+- Edema accompanying congestive heart failure
+- Edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function.
+
+Metolazone is also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class.
","Thiazide diuretics & related drugs
","Metolazone is a thiazide-like diuretic. It inhibits reabsorption of sodium in the distal tubules resulting in increased excretion of sodium and water, as well as potassium and hydrogen ions.
","Effective dosage of Metolazone tablets should be individualized according to indication and patient response. A single daily dose is recommended. Therapy with Metolazone tablets should be titrated to gain an initial therapeutic response and to determine the minimal dose possible to maintain the desired therapeutic response.
Usual Single Daily Dosage Schedules: Suitable initial dosages will usually fall in the ranges given.
Edema of Cardiac Failure: Metolazone tablets 5 to 20 mg once daily.
Edema of Renal Disease: Metolazone tablets 5 to 20 mg once daily.
Mild to Moderate Essential Hypertension: Metolazone tablets 2.5 to 5 mg once daily.
New patients- If considered desirable to switch patients currently on Zaroxolyn tablets and other formulations of Metolazone that share its slow and incomplete bioavailability to Mykrox , the dose should be determined by titration starting at one tablet (0.5 mg) once daily and increasing to two tablets (1 mg) once daily if needed.
Treatment Of Edematous States: The time interval required for the initial dosage to produce an effect may vary. Diuresis and saluresis usually begin within one hour and persist for 24 hours or longer. When a desired therapeutic effect has been obtained, it may be advisable to reduce the dose if possible. The daily dose depends on the severity of the patient's condition, sodium intake, and responsiveness. A decision to change the daily dose should be based on the results of thorough clinical and laboratory evaluations. If antihypertensive drugs or diuretics are given concurrently with Metolazone tablets, more careful dosage adjustment may be necessary. For patients who tend to experience paroxysmal nocturnal dyspnea, it may be advisable to employ a larger dose to ensure prolongation of diuresis and saluresis for a full 24-hour period.
Treatment Of Hypertension: The time interval required for the initial dosage regimen to show effect may vary from three or four days to three to six weeks in the treatment of elevated blood pressure. Doses should be adjusted at appropriate intervals to achieve maximum therapeutic effect.
",,"Hypotensive and nephrotoxic effects of ACE inhibitors may be enhanced. Absorption may be reduced with bile acid sequestrants. Hyperglycaemic effect may be enhanced with diazoxide. May increase serum concentration and QTc-prolonging effect of dofetilide. May reduce lithium excretion. Hypotensive effect may be increased with alcohol.
","Anuria; hepatic coma or pre-coma. Pregnancy.
","Chest pain, palpitation, necrotising angiitis, orthostatic hypotension, syncope, venous thrombosis, vertigo, volume depletion; depression, dizziness, chills, drowsiness, fatigue, restlessness, headache, lightheadedness; petechiae, photosensitivity, hypersensitivity reactions; gout attacks, electrolyte disturbances; abdominal bloating, diarrhoea, abdominal pain, anorexia, constipation, epigastric distress, nausea, xerostomia, pancreatitis, vomiting; impotence; aplastic anaemia, thrombocytopenia, haemoconcentration, leukopenia; cholestatic jaundice, hepatitis; joint pain, muscle cramps, weakness, neuropathy, paraesthesia; blurred vision; increased BUN, glucosuria.
","Pregnancy Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
If used in gestational HTN: Pregnancy Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Pre-diabetes or DM; gout; SLE; hepatic and renal impairment; hypercholesterolaemia. Correct electrolyte disturbances prior to therapy. Risk of cross-sensitivity with sulfonamides, sulfonylureas, carbonic anhydrase inhibitors, thiazides and loop diuretics. Lactation.
",,"Symptoms: Orthostatic hypotension, dizziness, drowsiness, syncope, haemoconcentration and haemodynamic changes due to plasma volume depletion.
Management: Symptomatic and supportive.
",,,,10
+748,Metoclopramide Hydrochloride,metoclopramide-hydrochloride-748,https://medex.com.bd/attachments/AWMSA0cMtAqtDTZG8ISWny7D3uyq7n/metoclopramide-hydrochloride-tablet-prescribing-information,Anti-emetic drugs,Vomiting,"Metoclopramide nasal spray: This is a dopamine-2 (D2) antagonist indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
Metoclopramide tablet:
+
+- This is indicated in the treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy.
... Read more
Metoclopramide nasal spray: This is a dopamine-2 (D2) antagonist indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
Metoclopramide tablet:
+
+- This is indicated in the treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy.
+- Relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
+
+
Metoclopramide Injection:
+
+- Diabetic Gastroparesis (Diabetic Gastric Stasis): Metoclopramide Injection is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis.
+- The Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy: Metoclopramide Injection is indicated for the prophylaxis of vomiting associated with emetogenic cancer chemotherapy.
+- The Prevention of Postoperative Nausea and Vomiting: Metoclopramide Injection is indicated for the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable.
+- Small Bowel Intubation: Metoclopramide Injection may be used to facilitate small bowel intubation in adults and pediatric patients in whom the tube does not pass the pylorus with conventional maneuvers.
+- Radiological Examination: Metoclopramide Injection may be used to stimulate gastric emptying and intestinal transit of barium in cases where delayed emptying interferes with radiological examination of the stomach and/or small intestine.
+
","Anti-emetic drugs, Prokinetic drugs
","Metoclopramide blocks dopamine receptors and in higher doses, it also blocks serotonin receptors in chemoreceptor trigger zone of the CNS. It enhances the response to acetylcholine of tissue in upper GI tract causing enhanced motility and accelerated gastric emptying w/o stimulating gastric, biliary, or pancreatic secretions. It also increases lower esophageal sphincter tone.
","Metoclopramide Spray:
Adults less than 65 years of age: The recommended dosage is 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum of 4 sprays daily) for 2 to 8 weeks, depending on symptomatic response.
Adults 65 years of age and older: Metoclopramide is not recommended in geriatric patients as initial therapy. Geriatric patients receiving an alternative metoclopramide product at a stable dosage of 10 mg four times daily can be switched to Metoclopramide 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum four times daily) for 2 to 8 weeks, depending on symptomatic response.
Metoclopramide tablet:
Gastroesophageal Reflux: Administer Metoclopramide continuously or intermittently:
+
+- Continuous: Administer 10 to 15 mg, 30 minutes before each meal and at bedtime (maximum of 60 mg per day) for 4 to 12 weeks.
+- Intermittent: Single doses up to 20 mg prior to provoking situation.
+
+Acute and Recurrent Diabetic Gastroparesis: Administer 10 mg, 30 minutes before each meal and at bedtime (maximum of 40 mg per day) for 2 to 8 weeks.
Metoclopramide injection:
For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis): If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with Metoclopramide Injection (IM or IV). Doses of 10 mg may be administered slowly by the intravenous route over a 1- to 2-minute period. Administration of Metoclopramide Injection (metoclopramide injection, USP) up to 10 days may be required before symptoms subside, at which time oral administration of metoclopramide may be instituted. The physician should make a thorough assessment of the risks and benefits prior to prescribing further metoclopramide treatment.
For the Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy: Intravenous infusions should be made slowly over a period of not less than 15 minutes, 30 minutes before beginning cancer chemotherapy and repeated every 2 hours for two doses, then every 3 hours for three doses. The initial two doses should be 2 mg/kg if highly emetogenic drugs such as cisplatin or dacarbazine are used alone or in combination. For less emetogenic regimens, 1 mg/kg per dose may be adequate.
For the Prevention of Postoperative Nausea and Vomiting: Metoclopramide Injection should be given intramuscularly near the end of surgery. The usual adult dose is 10 mg; however, doses of 20 mg may be used.
",,,"Metoclopramide is contraindicated:
+
+- In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide.
+- When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation).
+- In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Reglan may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor.
+- In patients with epilepsy. Reglan may increase the frequency and severity of seizures.
+- In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm.
+
","Most common adverse reactions (≥5%) are: dysgeusia, headache, and fatigue.
","Pregnancy Category B. Reproduction studies performed in rats, mice and rabbits by the IM, IV, subcutaneous (SC), and oral routes at maximum levels ranging from 12 to 250 times the human dose have demonstrated no impairment of fertility or significant harm to the fetus due to metoclopramide. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers: Metoclopramide is excreted in human milk. Caution should be exercised when metoclopramide is administered to a nursing mother.
","Tardive Dyskinesia (TD), Other Extrapyramidal Symptoms (EPS), and Neuroleptic Malignant Syndrome (NMS): Avoid concomitant use of other drugs known to cause TD/EPS/NMS and avoid use in patients with Parkinson’s Disease. If symptoms occur, discontinue Reglan and seek immediate medical attention.
Depression and suicidal ideation/suicide: Avoid use.
",,,,,"Store between 20-25°C. Protect from light.
",9
+747,Methylprednisolone Sodium Succcinate,methylprednisolone-sodium-succcinate-747,https://medex.com.bd/attachments/Heg4fs0przHmEF5OBaIVYi4ukC72i5/methylprednisolone-sodium-succcinate-prescribing-information,Glucocorticoids,Vestibular neuritis,"Methylprednisolone Sodium Succinate IM/IV is indicated in the following conditions:
Endocrine disorder: Primary or secondary adrenocortical insufficiency, acute adrenocortical insufficiency, shock unresponsive to conventional, congenital adrenal hyperplasia, Nonsuppurative ... Read more
Methylprednisolone Sodium Succinate IM/IV is indicated in the following conditions:
Endocrine disorder: Primary or secondary adrenocortical insufficiency, acute adrenocortical insufficiency, shock unresponsive to conventional, congenital adrenal hyperplasia, Nonsuppurative thyroiditis. Hypercalcemia associated with cancer.
Rheumatic disorder: Rheumatoid arthritis, including juvenile rheumatoid arthritis, acute and subacute bursitis, epicondylitis, acute nonspecific tenosynovitis, acute gouty arthritis, psoriatic arthritis, ankylosing spondylitis.
Collagen disease: During an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus; acute rheumatic carditis, systemic dermatomyositis (polymyositis).
Dermatological disease: Pemphigus, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, bullous dermatitis herpetiformis, severe seborrheic dermatitis, severe psoriasis, mycosis fungoides.
Allergic states: Controls bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, seasonal or perennial allergic rhinitis, drug hypersensitivity reaction, urticarial transfusion reactions, acute noninfectious laryngeal edema (epinephrine is the drug of first choice), anaphylactic reactions.
Ophthalmic disease: Severe acute and chronic allergic and inflammatory processes involving the eye, such as: herpes zoster ophthalmicus, iritis, iridocyclitis, chorioretinitis, diffuse posterior uveitis and chroiditis, optic neuritis, sympathetic ophthalmia, anterior segment inflammation, allergic conjunctivitis, allergic corneal marginal ulcers, keratitis.
Gastrointestinal disease: To tide the patient over a critical period of the disease in: ulcerative colitis (systemic therapy), regional enteritis (systemic therapy), Crohn’s disease.
Respiratory disease: Symptomatic sarcoidosis, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculosis chemotherapy, Loafer syndrome not manageable by other means, aspiration pneumonitis.
Hematologic disorder: Acquired (autoimmune) hemolytic anemia, idiopathic thrombocytopenic purpura in adults (IV only, IM administration is contraindicated), erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia, secondary thrombocytopenia in adults.
Neoplastic disease: For palliative management of: leukemias and lymphoma in adults, acute leukemia of childhood.
Edematous state: To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia of the idiopathic type or that due to lupus erythematosus.
Miscellaneous: Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculosis chemotherapy. Trichinosis with neurologic or myocardial involvement.
","Glucocorticoids
","Methylprednisolone, a naturally occurring glucocorticoid (hydrocortisone and cortisone), which has also salt-retaining properties, is used as replacement therapy in adrenocortical deficiency states. This synthetic analog is primarily used for its potent anti-inflammatory effects in disorders of many organ systems. The intravenous injection of Methylprednisolone Sodium Succinate, demonstrable effects are evident within one hour and persist for a variable period. Excretion of the administered dose is nearly complete within 12 hours. Thus, if constantly high blood levels are required, injections should be made every 4 to 6 hours. This preparation is also rapidly absorbed when administered intramuscularly and is excreted in a pattern similar to that observed after intravenous injection. Its anti-inflammatory potency is greater than prednisolone in the ratio of 5 to 4. It has only minimal mineralocorticoid properties and has less tendency than prednisolone to induce sodium and water retention. It influences carbohydrate, protein, fat and purine metabolism, electrolyte and water balance, and the functional capacities of the cardiovascular system, the kidney, the skeletal muscle, nervous system and other organs and tissues. It exerts a suppressive effect on the immune response.
","Methylprednisolone may be administered by IM or IV or by IV infusion. To administer by IM or IV injection, prepare solution as direction for reconstitution. The desired dose may be administered intravenously over a period of several minutes. When high dose therapy is desired, the recommended dose of Methylprednisolone Sodium Succinate for Injection, USP is 30 mg/kg administered intravenously over at least 30 minutes. This dose may be repeated every 4 to 6 hours for 48 hours. In general, high-dose corticosteroid therapy should be continued only until the patient’s condition has stabilized usually not beyond 48 to 72 hours.
Although adverse effects associated with high dose short-term corticoid therapy are uncommon, peptic ulceration may occur. Prophylactic antacid therapy may be indicated.
In other indications, the initial dosage will vary from 10 to 40 mg of Methylprednisolone depending on the clinical problem being treated. The larger doses may be required for short-term management of severe, acute conditions. The initial dose usually should be given intravenously over a period of several minutes. Subsequent doses may be given intravenously or intramuscularly at intervals dictated by the patient’s response and clinical condition. Corticoid therapy is an adjunct to, and not a replacement for conventional therapy.
Dosage must be decreased or discontinued gradually when the drug has been administered for more than a few days. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued. Routine laboratory studies, such as urinalysis, two-hour postprandial blood sugar, determination of blood pressure and body weight, and a chest X-ray should be made at regular intervals during prolonged therapy. Upper GI X-rays are desirable in patients with an ulcer history or significant dyspepsia.
In pediatric patients, the initial dose of Methylprednisolone may vary depending on the specific disease being treated. The initial dose is 0.11-1.6 mg/day in three or four divided doses. Dosage may be reduced for infants and children but should be governed more by the severity of the condition and response of the patient than by age or size but it should not be less than 0.5 mg per kg every 24 hours.
In the treatment of acute exacerbations of multiple sclerosis daily doses is 160 mg daily for 3 days. Methylprednisolone powder for injection/infusion should be given as an intravenous infusion over at least 30 minutes.
",,"
+- Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression.
+- Amphotericin B injection and potassium-depleting agents- When corticosteroids are administered concomitantly with potassium-depleting agents (i.e., amphotericin B, diuretics), patients should be observed closely for the development of hypokalemia.
+- Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance.
+- Anticholinesterases- Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.
+- Anticoagulants, oral- Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports.
+- Antidiabetics- Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.
+- Antitubercular drugs- Serum concentrations of isoniazid may be decreased.
+- Cholestyramine may increase the clearance of corticosteroids.
+- Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.
+- Digitalis glycosides- Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.
+- Estrogens, including oral contraceptives- Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.
+- Hepatic Enzyme Inhibitors- Drugs which inhibit cytochrome P450 3A4 have the potential to result in increased plasma concentrations of corticosteroids.
+- Ketoconazole has been reported to significantly decrease the metabolism of certain corticosteroids by up to 60%, leading to an increased risk of corticosteroid side effects.
+- Nonsteroidal anti-inflammatory agents (NSAIDs)- Concomitant use of aspirin and corticosteroids increases the risk of gastrointestinal side effects.
+- Skin tests- Corticosteroids may suppress reactions to skin tests.
+- Vaccines- Patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response.
+
","Methylprednisolone Sterile Powder is contraindicated:
+
+- In systemic fungal infections and patients with known hypersensitivity to the product and its constituents.
+- For intrathecal administration. Reports of severe medical events have been associated with this route of administration.
+- Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.
+
","Fluid and Electrolyte Disturbances: Sodium retention, fluid retention, congestive heart failure in susceptible patients, potassium loss, hypokalemic alkalosis, hypertension.
Musculoskeletal: Muscle weakness, steroid myopathy, loss of muscle mass, severe arthralgia, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones, osteoporosis.
Gastrointestinal: Peptic ulcer with possible perforation and hemorrhage, pancreatitis, abdominal distention, and ulcerative esophagitis.
Dermatologic: Impaired wound healing, thin fragile skin, petechiae and ecchymoses, facial erythema, increased sweating, may suppress reactions to skin tests.
Neurological: Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment, convulsions, vertigo, headache.
Endocrine: Development of Cushingoid state, suppression of growth in children, secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness, menstrual irregularities, decreased carbohydrate tolerance, manifestations of latent diabetes mellitus, increased requirements for insulin or oral hypoglycemic agents in diabetics.
Ophthalmic: Posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos.
Others: Negative nitrogen balance due to protein catabolism.
The following additional adverse reactions are related to parenteral corticosteroid therapy: hyperpigmentation or hypopigmentation, subcutaneous and cutaneous atrophy, sterile abscess, anaphylactic reaction with or without circulatory collapse, cardiac arrest, bronchospasm, urticaria, nausea and vomiting, cardiac arrhythmias; hypotension or hypertension.
","Pregnancy: Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
Lactation: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to continue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
","Methylprednisolone, like many other steroid formulations, is sensitive to heat. Therefore, it should not be autoclaved when it is desirable to sterilize the exterior of the vial. The lowest possible dose of corticosteroid should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. For chronic conditions, discontinuation of corticosteroids may result in clinical improvement.
","Pediatric Use: The adverse effects of corticosteroids in pediatric patients are similar to those in adults. Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose.
+
Geriatric Use: Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, refecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy.
","Treatment of acute over dosage is by supportive and symptomatic therapy. For chronic over dosage in the face of severe disease requiring continuous steroid therapy, the dosage of the corticosteroid may be reduced only temporarily or alternate day treatment may be introduced.
",,"Directions for Reconstitution-
+
+- Remove protective plastic flip-of seal.
+- Cleanse stopper with a suitable germicide.
+- Aseptically add 8 mL Water for Injection BP for the 500 mg vial or 16 ml for 1 gm vial by means of a syringe into the vial.
+- Agitate to effect solution to dissolve the powder content.
+- Invert vial. Insert the needle through the target area of stopper until the tip is just visible. Withdraw dose.
+
","Protect from light. Store at controlled room temperature 20° to 25°C. Store solution at controlled room temperature 20° to 25°C.Use solution within 48 hours after mixing.
",13
+746,Methylprednisolone Acetate,methylprednisolone-acetate-746,,Glucocorticoids,Wiskott-Aldrich syndrome,"Methyl Prednisolone Acetate is indicated in the treatment of asthma, atopic dermatitis, contact dermatitis, bullous dermatitis herpetiformis, mycosis fungoides, pemphigus, severe erythema multiforme, primary or secondary adrenocortical insufficiency, hypercalcemia associated with cancer, nonsuppurative ... Read more
Methyl Prednisolone Acetate is indicated in the treatment of asthma, atopic dermatitis, contact dermatitis, bullous dermatitis herpetiformis, mycosis fungoides, pemphigus, severe erythema multiforme, primary or secondary adrenocortical insufficiency, hypercalcemia associated with cancer, nonsuppurative thyroiditis, ulcerative colitis, hematologic disorders, palliative management of leukemias and lymphomas, sympathetic ophthalmia, keratitis, allergic conjunctivitis, Juvenile rheumatoid arthritis, ankylosing spondylitis, symptomatic sarcoidosis, aspiration pneumonitis.
","Glucocorticoids
","Methylprednisolone binds to and activates intracellular glucocorticoid receptors. Activated glucocorticoid receptors bind to promoter regions of DNA (which may activate or suppress transcription). Unbound glucocorticoids cross cell membranes and bind with high affinity to specific cytoplasmic receptors, modifying transcription and protein synthesis. By this mechanism, glucocorticoids can inhibit leukocyte infiltration at the site of inflammation, interfere with mediators of inflammatory response, and suppress humoral immune responses. The antiinflammatory actions of corticosteroids are thought to involve phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.
","1. Administration For Local Effect:
Rheumatoid and Osteoarthritis: The dose for intra-articular administration depends upon the size of the joint and varies with the severity of the condition in the individual patient. The doses in the following table are given as a general guide:
+
+- Large Size of joint (Knees, Ankles, Shoulders): 20 to 80 mg
+- Medium Size of joint (Elbows, Wrists): 10 to 40 mg
+- Small Size of joint (Metacarpophalangeal, Interphalangeal, Sternoclavicular, Acromioclavicular): 4 to 10 mg.
+
+
Miscellaneous (Ganglion, Tendinitis, Epicondylitis): The dose in the treatment of the various conditions of the tendinous or bursal structures varies with the condition being treated and ranges from 4 to 30mg. In recurrent or chronic conditions, repeated injections may be necessary.
Dermatological Conditions: 20 to 60mg of the suspension is injected into the lesion. It may be necessary to distribute doses ranging from 20 to 40mg by repeated local injections in the case of large lesions. One to four injections are usually employed, the intervals between injections varying with the type of lesion being treated and the duration of improvement produced by the initial injection.
2. Administration For Systemic Effect: In patients with the adrenogenital syndrome, a single intramuscular injection of 40mg every two weeks may be adequate. For maintenance of patients with rheumatoid arthritis, the weekly intramuscular dose will vary from 40 to 120 mg. The usual dosage for patients with dermatologic lesions benefited by systemic corticoid therapy is 40 to 120 mg of methylprednisolone acetate administered intramuscularly at weekly intervals for one to four weeks. In acute severe dermatitis due to poison ivy, relief may result within 8 to 12 hours following intramuscular administration of a single dose of 80 to 120mg. In chronic contact dermatitis, repeated injections at 5 to 10 day intervals may be necessary. In seborrheic dermatitis, a weekly dose of 80mg may be adequate to control the condition. Following intramuscular administration of 80 to 120 mg to asthmatic patients, relief may result within 6 to 48 hours and persist for several days to two weeks. Similarly in patients with allergic rhinitis (hay fever), an intramuscular dose of 80 to 120mg may be followed by relief of coryzal symptoms within six hours persisting for several days to three weeks.
3. Multiple Sclerosis: In treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of methylprednisolone for a week followed by 64mg every other day for 1 month have been shown to be effective (4mg of methylprednisolone is equivalent to 5mg of prednisolone). Or, as directed by the registered physician.
",,"Convulsions have been reported with concurrent use of methylprednisolone and cyclosporine. Drug that induce hepatic enzymes such as phenobarbital, phenytoin and rifampicin may increase the clearance of methylprednisolone. Drug such as troleandomycin and ketoconazole may inhibit the metabolism of methylprednisolone and decrease its clearance. Methylprednisolone may increase the clearance of chronic high dose aspirin. There are reports of enhanced as well as diminished effects of anticoagulant when given concurrently with corticosteroids.
","Methylprednisolone acetate sterile aqueous suspension is contraindicated for intrathecal administration. It is also contraindicated in systemic fungal infections and patients with known hypersensitivity to the product and its constituents.
","Congestive heart failure in susceptible patients, hypertension, sodium retention, muscle weakness, osteoporosis, peptic ulcer with possible subsequent and hemorrhage, abdominal distention, increased sweating, convulsion, vertigo, headache, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness, increased intraocular pressure, glaucoma, allergic or hypersensitivity reactions, urticaria, hyperpigmentation or hypopigmentation.
","Pregnancy Category C. Since adequate human reproduction studies have not been done with corticosteroids, the use of these drug in pregnancy, nursing mothers, or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus.
","Corticosteroids should be used cautiously in patients with ocular herpes simplex, nonspecific ulcerative colitis, renal insufficiency, hypertension, osteoporosis and myasthenia gravis.
",,,,,"Store between 20-25° C.
",10
+1323,Methylprednisolone,methylprednisolone-1323,,Glucocorticoids,Rheumatic disorders,"Endocrine Disorders: Primary or Secondary Adrenocortical Insufficiency, Congenital Adrenal Hyperplasia, Nonsuppurative Thyroiditis, Hypercalcemia associated with Cancer.
Rheumatic Disorders: Rheumatoid Arthritis. Juvenile Rheumatoid Arthritis, Ankylosing ... Read more
Endocrine Disorders: Primary or Secondary Adrenocortical Insufficiency, Congenital Adrenal Hyperplasia, Nonsuppurative Thyroiditis, Hypercalcemia associated with Cancer.
Rheumatic Disorders: Rheumatoid Arthritis. Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis, Acute and Subacute Bursitis, Synovitis of Osteoarthritis, Acute nonspecific Tenosynovitis, Post-traumatic Osteoarthritis, Psoriatic Arthritis, Epicondylitis, Acute Gouty Arthritis.
Collagen Diseases: Systemic lupus Erythematosus, Systemic Dermatomyositis and Acute Rheumatic Carditis.
Dermatologic Diseases: Bullous Dermatitis Herpetiformis, Severe Erythema Multiforme (Stevens-Johnson syndrome), Severe Seborrheic Dermatitis, Exfoliative Dermatitis, Mycosis Fungoides, Pemphigus, Severe Psoriasis.
Allergy: Seasonal or Perennial Allergic Rhinitis, Drug hypersensitivity reactions, Serum Sickness, Contact Dermatitis, Bronchial Asthma and Atopic Dermatitis;
Ophthalmic Diseases: Allergic Corneal Ulcers, Herpes Zoster Ophthalmicus, Anterior segment inflammation, Sympathetic Ophthalmia, Keratitis, Optic Neuritis, Allergic Conjunctivitis, Chorioretinitis, iritis end iridocyclitis.
Respiratory Diseases: Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, Aspiration Pneumonitis.
Hematological Disorders: Idiopathic Thrombocytopenic Purpura in adults, Secondary Thrombocytopenia in adults, Acquired (Autoimmune) Hemolytic Anemia, Erythroblastopenia, Congenital (Erythroid) Hypoplastic Anemia.
Neoplastic Diseases: For palliative management of Leukemias and Lymphomas in adults, Acute leukemia of childhood.
Edematous States: To induce a diuresis or remission of Proteinuria in the Nephrotic Syndrome, without Uremia, of the idiopathic type or that due to Lupus Erythematosus.
Gastrointestinal Disease: To tide the patient over a critical period of the disease in Ulcerative Colitis & Regional Enteritis.
CNS Disease: Acute Exacerbations of Multiple Sclerosis.
","Glucocorticoids
","Pharmacodynamic properties: Methylprednisolone Is a potent anti-inflammatory agent with the capacity to profoundly inhibit the immune system. Glucocorticoids primarily bind to and activate intracellular glucocorticoid receptors that being activated bind to promoter regions of DMA (which may activate or suppress transcription) and activate transcription factors that result in inactivation of genes through deacetylation of histones. Methylprednisolone influences the kidney and fluid & electrolyte balance, lipid,
protein, and carbohydrate metabolism, skeletal muscle, the cardiovascular system, the immune system, the nervous system, and the endocrine system.
Pharmacokinetic properties: The absolute bioavailability of Methylprednisclone is generally high (82% to 89%) following oral administration and rapidly absorbed and the maximum plasma concentration is achieved around 1.5 to 2.3 hours across doses following oral administration in normal healthy adults. Methylprednisolone is widely distributed into the tissues and its volume of distribution is 41-61.5 liter. It crosses the Wood-brain barrier and the placental barrier and is secreted in breast milk. The plasma protein binding of Methylprednisolone in humans is approximately 77%. Methylprednisolone is metabolized in the liver to inactive metabolites. No dosing adjustments are necessary for renal failure. Methylprednisolone is haemodializable.
","The usual range is 2-48 mg daily in divided doses, depending on the specific disease being treated.
As anti-inflammatory or immunosuppressive initial dosage: As anti-inflammatory or immunosuppressive, the initial dosage of Methylprednisolone tablets may vary from 4-48 mg per day depending on the specific disease entity being treated, in situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory dirtied response, Methylprednisolone should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be Individualized on the basis of the disease under treatment and the response of the patient.
As anti-inflammatory or immunosuppressive maintenance dosage: After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis: In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of Methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.
Methylprednisolone 4 mg tablet can be used to treat and to control severe allergy end dermatitis following the guideline listed below to minimize the steroid withdrawal syndromes:
+
+- Day 1: 2 tablets before breakfast + 1 tablet after lunch + 1 tablet after dinner + 2 tablets at bedtime
+- Day 2: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet after dinner + 2 tablets at bedtime
+- Day 3: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet after dinner + 1 tablet at bedtime
+- Day 4: 1 tablet before breakfast + 1 tablet after lunch + 1 tablet at bedtime
+- Day 5: 1 tablet before breakfast + 1 tablet at bedtime
+- Day 6: 1 tablet before breakfast
+
+
Alternate-day therapy (ADT): Alternate-day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids, white minimizing certain undesirable effects, including pituitary-adrenal suppression, Cushingoid stats, Corficoid withdrawal symptoms, and growth suppression in children.
The following should be kept in mind when considering alternate-day therapy:
+
+- Basic principles and indications for corticosteroid therapy should be applied.
+- Alternate-day therapy is a therapeutic technique primarily designed for pefienis in whom long-term pharmacologic corticoid therapy is anticipated.
+- In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate-day therapy. More severe disease state usually will require daily divided high dose therapy for initiai control of the disease process. The initial suppressive dose level should be continued until a satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases.
+
",,"Erythromycin, Clarithromycin, Phenobarbital, Phenytoin, Rifampin and Ketoconazole inhibit the metabolism of Methylprednisolone. Estrogens, including With control pills, can increase the effect of corticosteroids by 50%. Cyclosporin reduces the metabolism of Methylprednisolone. while Methylprednisolone reduces the metabolism of Cyclosporin. Methylprednisolone may increase or decrease the effect of blood thinners (e.g. Warfarin). For all these Interactions, the dose of Methylprednisolone may need to be lowered.
","Systemic fungal infections arid known hypersensitivity to components.
","Short courses of Methylprednisolone are usually well-tolerated with few, mild side effects. Long term, high doses of Methyiprednisoione may produce predictable and potentially serious side effects. Whenever possible, the lowest effective doses of Methylprednisolone should be used for the shortest length of time to minimize side effects. Alternate day dosing also can help reduce side effects. Side effects of Methylprednisolone and other corticosteroids range from mild annoyances to serious irreversible bodily damage. Side effects include fluid retention, weight gain, high blood pressure, potassium loss, headache, muscle weakness, hair growth on the face, glaucoma, cataracts, peptic ulceration, growth retardation in children, convulsions, and psychic disturbances including depression, euphoria, insomnia etc. Prolonged use of Methylprednisolone can depress the ability of the body's adrenal glands to produce corticosteroids. Abruptly stopping Methylprednisolone in these individuals can cause symptoms of corticosteroid insufficiency, with accompanying nausea, vomiting, and even shock. Therefore, withdrawal of Methylprednisolone usually is accomplished by gradually lowering the dose. Gradually tapering Methylprednisolone not only minimizes the symptoms of corticosteroid insufficiency, it also reduces the risk of an abrupt flare of the disease being treated.
","Pregnancy category C. Dregs should be given only if the potential benefit justifies the potential risk te the foetus. Mefhyiprednisofone has not been adequately evaluated in nursing mothers.
","Adrenocortical insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
",,"Report of acute toxicity and/or death following an overdose of glucocorticoid ere rare. No specific antidote is available; treatment is supportive and symptomatic. Serum electrolytes should be monitored.
",,,"Store in a cool and dry place, away from light. Keep out of reach of children.
",11
+745,Methylphenidate Hydrochloride,methylphenidate-hydrochloride-745,https://medex.com.bd/attachments/ZXQXNIZErLaiTIuwrz1Z4YOcKidn5e/methylphenidate-hydrochloride-sustained-release-tablets-prescribing-information,CNS stimulant drugs,Narcolepsy,"Methylphenidate is used in the treatment of attention deficit hyper activity disorder (ADHD) and narcolepsy.
","CNS stimulant drugs
","methylphenidate (MPH) has been shown to act as a norepinephrine and dopamine reuptake inhibitor (NDRI), thereby increasing the presence of these neurotransmitters in the extraneuronal space and prolonging their action. There is a dose-related effect of psychostimulants on receptor stimulation, where higher doses are shown to increase norepinephrine (NE) and dopamine (DA) efflux throughout the brain which can result in impaired cognition and locomotor-activating effects. In contrast, low doses are found to selectively activate NE and DE neurotransmission within the prefrontal cortex which is an area of the brain thought to play a prominent role in ADHD pathophysiology, thereby improving clinical efficacy and preventing side effects. The lower doses used to treat ADHD are not associated with the locomotor-activating effects associated with higher doses and instead reduce movement, impulsivity, and increase cognitive function including sustained attention and working memory. Methylphenidate's beneficial effects in sustaining attention have also been shown to be mediated by alpha-1 adrenergic receptor activity.
Clinical findings have shown that children with ADHD have an abnormality in the dopamine transporter gene (DAT1), the D4 receptor gene (DRD-4), and/or the D2 receptor gene that may be at least partly overcome by the dopaminergic effects of methylphenidate, suggesting a possible mode of action.
","Child: Over 6 years, initially 5 mg 1-2 times daily, increased if necessary at weekly intervals by 5-10 mg daily to max. 60 mg daily in divided doses; discontinue if no response after one month also suspend periodically to assess child’s condition (usually finally discontinued during or after puberty); Child under 6 years not recommended.
Adult: 10-15 mg daily in divided doses (2-3 times daily). Average dosage is 20-30 mg daily. Some patients may require 40-60 mg daily. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 pm.
","Should be taken on an empty stomach. Take 30-45 min before meals. May be taken with or without food. Swallow whole, do not divide/chew/crush.
","The elimination of phenytoin is slowed by methylphenidate. It may also increase the anticoagulant effect of Coumarin. It also increases the serum concentration of imipramine and desipramine.
","Methylphenidate is contraindicated in alcoholics, emotionally unstable patients, drug abusers, hypertension, cardiac arrhythmias, psychoses, epilepsy, thyro-toxicosis, glaucoma marked anxiety, severe depression and known sensitivity to methylphenidate.
","Sleep disturbances, restlessness, dizziness, headache, tremor, convulsion, rash, pruritis; urticaria, fever, arthralgia, alopecia, exfoliative, dermatitis, erythema multiforme, thrombocytopenic purpuria, thrombocytopenia, Leucopenia, urinary disorder and very rarely liver damage.
","The use of methylphenidate in pregnancy and lactation has not been established.
","In mild hypertension (contraindicated if moderate or severe)-monitor blood pressure; history of epilepsy; tics and Tourette syndrome. Occasional cystic ovarian swellings in premenopausal women, occasional hypercalcemia if bony metastases; increased risk of thromboembolic events when used with cytotoxics; breast feeding; endometrial changes; porphyria
",,,,,"Store in a cool (below 25°C) and dry place, away from light. Keep out of reach of the children.
",11
+1482,Methylergonovine Maleate,methylergonovine-maleate-1482,https://medex.com.bd/attachments/3nl7zx4b0GNogeNVvYxEOdZGJZyhFH/methylergonovine-maleate-prescribing-information,Drugs acting on the Uterus,Uterine hemorrhage,"Following delivery of the placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.
","Drugs acting on the Uterus
","Methylergonovine Maleate acts directly on the smooth muscle of the uterus and increases the tone, rate, and amplitude of rhythmic contractions. Thus, it induces a rapid and sustained tetanic uterotonic effect which shortens the third stage of labor and reduces blood loss. The onset of action after I.V. administration is immediate; after I.M. administration, 2-5 minutes, and after oral administration, 5-10 minutes.
","Intramuscularly: 1 ml/0.2 mg, after delivery of the anterior shoulder, after delivery of the placenta, or during the puerperium. May be repeated as required, at intervals of 2-4 hours.
Intravenously: 1 ml/0.2 mg, administered slowly over a period of no less than 60 seconds
Orally: One tablet, 0.2 mg, 3 or 4 times daily in the puerperium for a maximum of 1 week.
",,"There have been rare reports of serious adverse events in connection with the coadministration of certain ergot alkaloid drugs (e.g., dihydroergotamine and ergotamine) and potent CYP 3A4 inhibitors, resulting in vasospasm leading to cerebral ischemia and/or ischemia of the extremities. Although there have been no reports of such interactions with methylergonovine alone, potent CYP 3A4 inhibitors should not be coadministered with methylergonovine. Examples of some of the more potent CYP 3A4 inhibitors include macrolide antibiotics (e.g., erythromycin, troleandomycin, clarithromycin), HIV protease or reverse transcriptase inhibitors (e.g., ritonavir, indinavir, nelfinavir, delavirdine) or azole antifungals (e.g., ketoconazole, itraconazole, voriconazole). Less potent CYP 3A4 inhibitors should be administered with caution. Less potent inhibitors include saquinavir, nefazodone, fluconazole, grapefruit juice, fluoxetine, fluvoxamine, zileuton, and clotrimazole. These lists are not exhaustive, and the prescriber should consider the effects on CYP 3A4 of other agents being considered for concomitant use with methylergonovine.
","Hypertension; toxemia; pregnancy; and hypersensitivity.
","The most common adverse reaction is hypertension associated in several cases with seizure and/or headache. Hypotension has also been reported. Abdominal pain (caused by uterine contractions), nausea and vomiting have occurred occasionally. Rarely observed reactions have included: acute myocardial infarction, transient chest pains, vasoconstriction, vasospasm, coronary arterial spasm, bradycardia, tachycardia, dyspnea, hematuria, thrombophlebitis, water intoxication, hallucinations, leg cramps, dizziness, tinnitus, nasal congestion, diarrhea, diaphoresis, palpitation, rash, and foul taste. There have been rare isolated reports of anaphylaxis, without a proven causal relationship to the drug product.
","Pregnancy Category C. Animal reproductive studies have not been conducted with Methylergonovine. It is also not known whether methylergonovine maleate can cause fetal harm or can affect reproductive capacity. Use of Methylergonovine is contraindicated during pregnancy because of its uterotonic effects.
Breast-feeding: Mothers should not breast-feed during treatment with Methylergonovine. Milk secreted during this period should be discarded. Methylergonovine may produce adverse effects in the breast-feeding infant. Methylergonovine may also reduce the yield of breast milk. Mothers should wait at least 12 hours after administration of the last dose of Methylergonovine before initiating or resuming breast feeding
","Caution should be exercised in the presence of sepsis, obliterative vascular disease. Also use with caution during the second stage of labor. The necessity for manual removal of a retained placenta should occur only rarely with proper technique and adequate allowance of time for its spontaneous separation.
","Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
","Symptoms of acute overdose may include: nausea, vomiting, oliquria, abdominal pain, numbness, tingling of the extremities, rise in blood pressure, in severe cases followed by hypotension, respiratory depression, hypothermia, convulsions, and coma.
",,,"Store below 25°C; in tight, light-resistant container.
",12
+744,Methyldopa,methyldopa-744,https://medex.com.bd/attachments/pMJI61azhhmlJhQBXA1LdCfnenljsB/methyldopa-prescribing-information,Centrally acting antihypertensive drugs (central sympatholytic),Hypertension,"Methyldopa is indicated in Hypertension.
","Centrally acting antihypertensive drugs (central sympatholytic)
","Methyldopa, or α-methyldopa, is a centrally acting sympatholytic agent and an antihypertensive agent. It is an analog of DOPA (3,4‐hydroxyphenylanine), and it is a prodrug, meaning that the drug requires biotransformation to an active metabolite for therapeutic effects. Methyldopa works by binding to alpha(α)-2 adrenergic receptors as an agonist, leading to the inhibition of adrenergic neuronal outflow and reduction of vasoconstrictor adrenergic signals. Methyldopa exists in two isomers D-α-methyldopa and L-α-methyldopa, which is the active form.
First introduced in 1960 as an antihypertensive agent, methyldopa was considered to be useful in certain patient populations, such as pregnant women and patients with renal insufficiency. Since then, methyldopa was largely replaced by newer, better-tolerated antihypertensive agents; however, it is still used as monotherapy or in combination with hydrochlorothiazide. Methyldopa is also available as intravenous injection, which is used to manage hypertension when oral therapy is unfeasible and to treat hypertensive crisis.
","Adults-
+
+- Initiation of Therapy: The usual starting dosage of Methyldopa is 250 mg two or three times a day in the first 48 hours. The daily dosage then may be increased or decreased, preferably at intervals of not less than two days, until an adequate response is achieved. To minimize the sedation, start dosage increases in the evening. When Methyldopa is given to patients on other antihypertensives, the dose of these agents may need to be adjusted to effect a smooth transition. When Methyldopa is given with antihypertensives other than thiazides, the initial dosage of Methyldopa should be limited to 500 mg daily in divided doses; when Methyldopa is added to a thiazide, the dosage of thiazide need not to be changed.
+- Maintenance Therapy: The usual daily dosage of Methyldopa is 500 mg to 2 g in two to four doses. Although occasional patients have responded to higher doses, the maximum recommended daily dosage is 3 gm. Occasionally tolerance may occur, usually between the second and third month of therapy. Adding a diuretic or increasing the dosage of Methyldopa frequently will restore effective control of blood pressure. A thiazide may be added at any time during Methyldopa therapy and is recommended if therapy'has not been started with a thiazide or if effective control of blood pressure cannot be maintained on 2 gm of Methyldopa daily. Methyldopa is largely excreted by the kidney and patients with impaired renal function may respond to smaller doses. Syncope in older patients may be related to an increased sensitivity and advanced arteriosclerotic vascular disease. This may be avoided by lower doses.
+
+
Pediatric Use: Initial dosage is based on 10 mg/kg of body weight daily in two to four doses. The daily dosage then is increased or decreased until an adequate response is achieved. The maximum dosage is 65 mg/kg or 3 gm daily, whichever is less.
",,"When Methyldopa is used with other antihypertensive drugs, potentiation of antihypertensive effect may occur. Patients may require reduced doses of anesthetics when on Methyldopa. When Methyldopa and lithium are given concomitantly the patient should be carefully monitored for symptoms of lithium toxicity. Coadministration of Methyldopa with ferrous sulfate or ferrous gluconate is not recommended.
","Methyldopa is contraindicated in patients:
+
+- with active hepatic disease, such as acute hepatitis and active cirrhosis
+- with liver disorders previously associated with Methyldopa therapy
+- with hypersensitivity to any component of these products
+- on therapy with monoamine oxidase (MAO) inhibitors.
+
","Sedation, usually transient, may occur during the initial period of therapy or whenever the dose is increased. Headache, asthenia, or weakness may be noted as early and transient symptoms. The following systemic side effects may rarely occur with the use of Methyldopa- angina pectoris, congestive heart failure, orthostatic hypotension, edema or weight gain, bradycardia, pancreatitis, colitis, vomiting, diarrhea, nausea, constipation, dryness of mouth, hyperprolactinemia, bone marrow depression, leukopenia, granulocytopenia, thrombocytopenia, hemolytic anemia; rheumatoid factor, hepatitis, jaundice, myocarditis, pericarditis, vasculitis, eosinophilia, parkinsonism, bell's palsy, nightmares and reversible mild psychoses or depression, dizziness, lightheadedness, paresthesias, arthralgia, myalgia, nasal stuffiness, rash, amenorrhea, gynecomastia, lactation, impotence. However, significant adverse effects due to Methyldopa have been infrequent and this agent usually is well tolerated.
","Pregnancy category B. Methyldopa appears in breast milk. Therefore, caution should be exercised when Methyldopa is given to a nursing woman.
","Methyldopa should be used with caution in patients with a history of previous liver disease or dysfunction. Some patients taking Methyldopa experience clinical edema or weight gain, which may be controlled by use of a diuretic. Methyldopa should not be continued if edema progresses or signs of heart failure appear. Hypertension has recurred occasionally after dialysis in patients given Methyldopa because the drug is removed by this procedure. Rarely involuntary choreoathetotic movements have been observed during therapy with Methyldopa in patients with severe bilateral cerebrovascular disease. If these movements occur, stop therapy
","Pediatric Use: There are no well-controlled clinical trials in pediatric patients. Information on dosing in pediatric patients is supported by evidence from published literature regarding the treatment of hypertension in pediatric patients.
","Acute overdosage may produce acute hypotension with other responses attributable to brain and gastrointestinal malfunction (excessive sedation, weakness, bradycardia, dizziness, lightheadedness, constipation, distention, flatus, diarrhea, nausea, vomiting). In the event of overdosage, symptomatic and supportive measures should be employed. When ingestion is recent, gastric lavage or emesis may reduce absorption. When ingestion has been earlier, infusions may be helpful to promote urinary excretion.
",,,"Do not store above 30°C. Keep out of the reach of children.
",12
+743,Methyl Salicylate + Menthol + Camphor,methyl-salicylate-menthol-camphor-743,https://medex.com.bd/attachments/s8HnH2CjgQx5n0w1o9Mhic1RSoeo9f/methyl-salicylate-menthol-camphor-prescribing-information,Topical anti-inflammatory preparations,Strains,"This cream is indicated for the fast relief of minor aches and pains of muscles and joints e.g., Simple Backache, Arthritis, Strains, Bruises and Sprains.
","Topical anti-inflammatory preparations
","This cream is a specially formulated Methyl salicylate, Menthol and Camphor cream. It penetrates into skin to provide fast relief from pain and stiffness of minor arthritis and muscle aches. It alleviates pain and inflammation by inhibiting the synthesis of prostaglandins that occur in inflamed tissues. Methyl salicylate has been shown that first pass metabolism exists in the skin and rapidly hydrolyzing salicylate ester to release the active salicylate in both epidermis and dermis. Menthol increases the penetration of drugs when applied on the skin to give a faster onset of action. It dilates the blood vessels causing a sensation of coldness followed by an analgesic effect. Camphor is a stimulant, used topically to increase local blood flow and as a 'counterirritant', which reduces pain & swelling. When in combination with other ingredients like menthol, methyl salicylate, it becomes ideal for neuralgia and other painful areas.
","Adults and children (12 years of age and older): Apply to affected area not more than 3 to 4 times daily.
Children under 12 years of age: Use on advice of a physician.
",,"There are no known drug interactions and none well documented.
","Hypersensitivity to salicylate or any of its ingredients.
","Redness or irritation may occur, especially in persons with sensitive skin.
","This medication should be used only if clearly needed during pregnancy or while breast-feeding.
","For external use only. Do not use-
+
+- on wounds or damaged skin
+- with a heating pad
+- on a child under 12 years of age with arthritis-like conditions.
+
",,,,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",10
+729,Methyl Salicylate + Menthol,methyl-salicylate-menthol-729,https://medex.com.bd/attachments/9T0PFypVBZi3tKszJSR8CI4gTrk3h6/methyl-salicylate-menthol-prescribing-information,Topical Analgesics,Trigeminal neuralgia,"This cream is indicated for the fast relief of minor aches and pains of muscles & joints associated with-
+
+- Joint Pain
+- Back Pain
+- Arthritic Pain
+- Neck & Shoulder Pain
+- Sprains
+- Strains
+
","Local Antipruritic, Topical Analgesics, Topical anti-inflammatory preparations
","This cream is a specially formulated Methyl salicylate and Menthol cream. It penetrates into skin to provide fast relief from pain and stiffness of minor arthritis and muscle aches. This cream is fast-acting, strong medicine that penetrates deep down to provide long-lasting and effective relief. Methyl salicylate has been shown that first-pass metabolism exists in the skin and rapidly hydrolyzing salicylate ester to release the active salicylate in both epidermis and dermis. It alleviates pain and inflammation by inhibiting the synthesis of prostaglandins that occur in inflamed tissues. Menthol increases the penetration of drugs when applied on the skin to give a faster onset of action. It dilates the blood vessels causing a sensation of coldness followed by an analgesic effect.
","Adult and children 2 years of age and older: Apply a thin layer to the affected area and gently massage until this cream disappears. Apply to the affected area not more than 3 to 4 times daily.
",,"Methyl Salicylate is systemically absorbed through the skin in measurable amounts and may increase Warfarin action by affecting Vitamin K metabolism or by displacing warfarin from protein-binding sites.
","Allergy to salicylate or sensitivity to any of the components. Application to broken skin or raw surfaces is contraindicated.
","Redness or irritation may occur, especially in persons with sensitive skin. Adverse reactions possibly involved are mild to moderate local irritation, erythema, rash, desquamation, pruritis and relative local reaction at the application site.
","This medication should be used only if clearly needed during pregnancy or while breast-feeding.
","For external use only. Use only as directed. Do not use with a heating pad. Keep away from children to avoid accidental ingestion. Do not swallow. If swallowed, get medical help or contact a poison control centre immediately. Do not bandage tightly. Keep away from eyes, mucous membranes, broken or irritated skin. If skin redness or excessive irritation develops, pain lasts for more than 10 days or with arthritis-like conditions in children under 12, do not use and call a physician.
",,"Large amount of topical application may cause absorption through the skin and may cause salicylism. Symptoms of salicylism include tinnitus,hearing loss, nausea, vomiting etc.
",,,"It should be stored in a cool and dry place, away from light, temperature not exceeding 30°C. Keep out of reach of children.
",11
+741,Methoxy Polyethylene Glycol-Epoetin Beta,methoxy-polyethylene-glycol-epoetin-beta-741,https://medex.com.bd/attachments/J8BcbgyRgxm5AeGGMo5n9A1eGuJQwU/methoxy-polyethylene-glycol-epoetin-beta-prescribing-information,Drugs for Haemolytic Hypoplastic & Renal Anemia,Chronic renal failure,"This is indicated for the treatment of anemia associated with chronic kidney disease (CKD) including patients on dialysis and patients not on dialysis.
","Drugs for Haemolytic Hypoplastic & Renal Anemia
","Methoxy polyethylene glycol-epoetin beta is a chemically synthesized continuous erythropoietin receptor activator. Methoxy polyethylene glycol-epoetin beta differs from erythropoietin through integration of an amide bond between either the N-terminal amino group or the ε amino group of lysine, predominantly Lys52 and Lys45 and methoxy polyethylene glycol butanoic acid. This results in a molecular weight of approximately 60,000 daltons for methoxy polyethylene glycol-epoetin beta with the PEG-moiety having an approximate molecular weight of 30,000 daltons.
In contrast with erythropoietin, methoxy polyethylene glycol-epoetin beta shows a different activity at the receptor level characterized by a slower association to and faster dissociation from the receptor, a reduced specific activity in vitro with an increased activity in vivo, as well as an increased half-life. These differential pharmacological properties are relevant in order to achieve a once monthly dosing regimen with methoxy polyethylene glycol-epoetin beta in patients.
Methoxy polyethylene glycol-epoetin beta stimulates erythropoiesis by interaction with the erythropoietin receptor on progenitor cells in the bone marrow. As primary growth factor for erythroid development, the natural hormone erythropoietin is produced in the kidney and released into the bloodstream in response to hypoxia. In responding to hypoxia, the natural hormone erythropoietin interacts with erythroid progenitor cells to increase red cell production.
","This preparation is administered less frequently than other erythropoiesis stimulating agents (ESAs) due to the longer elimination half-life. Treatment with this preparation has to be initiated under the supervision of a healthcare professional.
Treatment of anemic patients with chronic kidney disease:
+
+- The solution can be administered subcutaneously (s.c.) or intravenously (i.v.), according to clinical preference.
+- This preparation can be injected subcutaneously in the abdomen, arm or thigh. All three injection sites are equally suitable for subcutaneous injection with this preparation.
+- It is recommended that hemoglobin is monitored every two weeks until stabilized, and periodically thereafter.
+
+Patients currently not treated with an Erythropoiesis Stimulating Agent:
+
+- Patients not on dialysis- In order to increase the haemoglobin to greater than 11 g/dl (6.83 mmol/L), the recommended starting dose is 1.2 microgram/kg body weight administered once every month as a single subcutaneous injection. Alternatively, a starting dose of 0.6 microgram/kg body weight may be administered once every two weeks as a single IV or SC injection.
+- Patients on dialysis- In order to increase the haemoglobin to greater than 11 g/dl (6.83 mmol/L), the recommended starting dose of 0.6 microgram/kg body weight may be administered once every two weeks as a single IV or SC injection.
+- The dose of this preparation may be increased by approximately 25 to 50% of the previous dose if the rate of rise in hemoglobin is less than 1.0 g/dl (0.621mmol/l) over a month. Further increases of approximately 25 to 50% may be made at monthly intervals until the individual target hemoglobin level is obtained.
+- If the rate of rise in hemoglobin is greater than 2 g/dl (1.24 mmol/l) in one month, the dose is to be reduced by approximately 25 to 50%. If the hemoglobin level exceeds 13 g/dl (8.07 mmol/l), therapy is to be interrupted until the hemoglobin level falls below 13 g/dl and then restarted with approximately 50% of the previously administered dose. For regions where the upper limit of hemoglobin level has been set at 12 g/dl, dose adjustments of 25% should be considered. After dose interruption a hemoglobin decrease of approximately 0.35 g/dl per week is expected.
+- Patients treated once every two weeks whose haemoglobin concentration is above 11 g/dl (6.83 mmol/l) may receive this preparation administered once monthly using the dose equally to twice the previous once every two weeks dose. Dose adjustments should not be made more often than once a month.
+
+Patients currently treated with an Erythropoiesis Stimulating Agent: Patients currently treated with an ESA can be converted to This preparation administered once a month or, if desired, once every two weeks as a single i.v. or s.c. injection. The starting dose of This preparation is based on the calculated previously given weekly dose of darbepoetin alfa or epoetin at the time of substitution as described in Tables 1 and 2 below. The first injection of This preparation should be administered at the next scheduled dose of the previously administered darbepoetin alfa or epoetin.
",,"No interaction studies have been performed. The clinical results do not indicate any interaction of Methoxy Polyethylene Glycol Epoetin Beta with other medicinal products. The effect of other drugs on the pharmacokinetics and pharmacodynamics of Methoxy Polyethylene Glycol Epoetin Beta was explored using a population analysis approach. There was no indication of an effect of concomitant medications on the pharmacokinetics and pharmacodynamics of Methoxy Polyethylene Glycol Epoetin Beta.
","Methoxy Polyethylene Glycol Epoetin Beta is contraindicated in patients with:
+
+- Uncontrolled hypertension.
+- Known hypersensitivity to the active substance or any of the excipients.
+
","Adverse reactions are Hypertension, Vascular access thrombosis, Headache, Hypersensitivity, Hypertensive encephalopathy, Rash (maculo-papular, serious).
","Pregnancy: There are no adequate data on the use of this preparation in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. Caution should be exercised when prescribing this preparation to pregnant women.
Nursing Mothers: It is unknown whether methoxy polyethylene glycol-epoetin beta is excreted in human breast milk. One animal study has shown excretion of methoxy polyethylene glycol-epoetin beta in maternal milk. A decision on whether to continue or discontinue breast-feeding or to continue or discontinue therapy with this preparation should be made taking into account the benefit of breast-feeding to the child and the benefit of this therapy to the woman.
","Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 µg/l or whose transferrin saturation is below 20%. To ensure effective erythropoiesis, iron status should be evaluated for all patients prior to and during treatment.
Lack of effect: The most common reasons for incomplete response to ESAs are iron deficiency and inflammatory disorders. The following conditions may also compromise the effectiveness of ESAs therapy: chronic blood loss, bone marrow fibrosis, severe aluminium overload due to treatment of renal failure, folic acid or vitamin B12 deficiencies, and hemolysis. If all the conditions mentioned are excluded and the patient has a sudden drop of hemoglobin associated with reticulocytopenia and anti erythropoietin antibodies, examination of the bone marrow for the diagnosis of Pure Red Cell Aplasia (PRCA) should be considered. If PRCA is diagnosed, therapy with MIRCERA must be discontinued and patients should not be switched to another ESA.
PRCA: PRCA caused by anti-erythropoietin antibodies has been reported in association with ESAs including MIRCERA. These antibodies have been shown to cross-react with all ESAs, and patients suspected or confirmed to have antibodies to erythropoietin should not be switched to MIRCERA.
Blood pressure monitoring: As with other ESAs, blood pressure may rise during treatment of anemia with MIRCERA. Blood pressure should be adequately controlled before, at initiation of and during treatment with MIRCERA. If high blood pressure is difficult to control by drug treatment or dietary measures, the dose of MIRCERA must be reduced or withheld.
","Pediatric use: Methoxy Polyethylene Glycol Epoetin Beta is not recommended for use in patients aged less than 18 years due to a lack of data on safety and efficacy.
Elderly: no adjustment of the starting dose is required in patients aged 65 years or older.
Hepatic Impairment: no adjustments of the starting dose nor dose modification rules are required in patients with any degree of hepatic impairment.
","The therapeutic range of Methoxy Polyethylene Glycol Epoetin Beta is wide and individual response to therapy must be considered when Methoxy Polyethylene Glycol Epoetin Beta treatment is initiated. Overdose can result in manifestations of an exaggerated pharmacodynamic effect, e.g. excessive erythropoiesis. In case of excessive hemoglobin levels, Methoxy Polyethylene Glycol Epoetin Beta should be temporarily withheld. If clinically indicated, phlebotomy may be performed.
",,,"This medicine should not be used after the expiry date (EXP) shown on the pack. Store in the refrigerator at 2°C to 8°C. Keep the pre-filled syringe in the outer carton in order to protect from light. Do not freeze. The patient may remove the product from refrigeration for storage at room temperature (not above 30°C) for one single period of 1 month. Once removed from the refrigerator the product must be used within this period.
",12
+740,Methoxsalen,methoxsalen-740,https://medex.com.bd/attachments/jTu4MO0khwXGWg8iQeve8CM4W5HRZz/methoxsalen-lotion-prescribing-information,Methoxsalen preparation,Vitiligo,"It is indicated for the repigmentation of idiopathic vitiligo. It is also indicated for the symptomatic control of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy and when the diagnosis has been supported by biopsy.
","Methoxsalen preparation
","The combination treatment regimen of Psoralen (P) and UVA (Ultraviolet radiation of 320-400 nm wavelength) is commonly known as PUVA. Skin reactivity to UVA radiation is enhanced by the ingestion of Methoxsalen. The drug reaches its maximum bioavailability 1-3 hours after oral administration and may last for up to 8 hours. Methoxsalen is reversibly bound to serum albumin and is also preferentially taken up by epidermal cells. In both mice and man, Methoxsalen is rapidly metabolized. Approximately 95% of the drug is excreted as a series of metabolites in the urine within 24 hours.
The exact mechanism of action of Methoxsalen with the epidermal melanocytes and keratinocytes is not known. The best known biochemical reaction of Methoxsalen is with DNA. Methoxsalen, upon photoactivation, conjugates and forms covalent bonds with DNA (both monofunctional and bifunctional). Reactions with proteins have also been described.
","Methoxsalen capsules:
Vitiligo therapy: Two Methoxsalen capsules (10 mg each) in one dose taken with milk or food two to four hours before ultraviolet light exposure.
Light exposure: The exposure time to sunlight should comply with the following guide:
+
+- Initial exposure: Light-15 min, Medium-20 min, Dark-25 min
+- Second exposure: Light-20 min, Medium-25 min, Dark-30 min
+- Third exposure: Light-25 min, Medium-30 min, Dark-35 min
+- Fourth exposure: Light-30 min, Medium-35 min, Dark-40 min
+
+
Subsequent exposure: Gradually increase exposure based on erythema and tenderness of the amelanotic skin. Therapy should be on alternate days and never two consecutive days.
Psoriasis therapy: The Methoxsalen capsules should be taken 2 hours before UVA exposure with some food or milk, according to the following table:
+
+- <30 kg body weight: 10 mg
+- 30-50 kg body weight: 20 mg
+- 51-65 kg body weight: 30 mg
+- 66-80 kg body weight: 40 mg
+- 81-90 kg body weight: 50 mg
+- 91-115 kg body weight: 60 mg
+- >115 kg body weight: 70 mg
+
+
Methoxsalen Lotion: is applied to a well-defined area of vitiligo by the physician and the area is then exposed to a suitable credit of UVA. Initial exposure time should be conservative and not exceed that which is predicted to be one-half the minimal erythema dose. Treatment intervals should be regulated by the erythema response; generally once a week is recommended or less often depending on results. The hands and fingers of the person applying the medication should be protected by gloves or finger cots to avoid photosensitization and possible burns.
Pigmentation may begin after a few weeks but significant repigmentation may require 6 to 9 months of treatment. Periodic re-treatment may be necessary to retain all of the new pigment. Idiopathic vitiligo is reversible but not equally reversible in every patient. Treatment must be individualized. Repigmentation will vary in completeness, time of onset, and duration. Repigmentation occurs more rapidly in fleshy areas such as face, abdomen, and buttocks and less rapidly over less fleshy areas such as the dorsum of the hands or feet.
","Hands and fingers of person applying the lotion should be protected to prevent possible photosensitization and/or burns.
","May increase plasma concentration of drugs metabolised by CYP2A6 isoenzyme. Additive effect with other systemic or topical photosensitising agents (e.g. anthralin, coal tar, nalidixic acid).
","
+- Patient with idiosyncratic reactions to psoralen compounds
+- Patient possessing light sensitive disease including lupus erythematosus, porphyria, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum and albinism
+- Patient with melanoma or possessing a history of melanoma
+- Patient with invasive squamous cell carcinomas
+- Patient with aphakia
+
","The most commonly reported side effect of Methoxsalen alone is nausea, which occurs with approximately 10% of all patients. This effect may be minimized or avoided by instructing the patient to take Methoxsalen with milk or food, or to divide the dose into two portions, taken approximately one-half hour apart. Other effects include nervousness, insomnia and psychological depression.
","Pregnancy Category C. Methoxsalen should be given to a woman only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Methoxsalen is administered to a nursing woman.
","Skin burning: Serious burns from either UVA or sunlight (even through window glass) can result if the recommended dosage of the drug and/or exposure schedules are not maintained.
Carcinogenicity: The increasing risk of carcinoma appears great among patients who are fair skinned or had pre PUVA exposure or prolong treatment with tar UVB, ionizing radiation or arsenic.
Cataractogenicity: Among patients using proper eye protection, there is no evidence for a significantly increased risk of cataracts in association with PUVA therapy.
Patients must not sunbathe during the 24 hours prior to Methoxsalen ingestion and UV exposure.
","Pediatric use: Safety in children has not been established.
","In the event of Methoxsalen overdosage, induce emesis and keep the patient in a darkened room for at least 24 hours. Emesis is beneficial only within the first 2 to 3 hours after ingestion of Methoxsalen, since maximum blood levels are reached by this time.
",,,"Store at 25°C; excursions permitted to 15°C-30°C.
",13
+739,Methotrexate,methotrexate-739,https://medex.com.bd/attachments/fX45WUYXIpo6T9eSFA3J6cHIu4wCs8/methotrexate-tablets-prescribing-information,Immunosuppressant,Vasculitis,"Neoplastic Diseases: Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. Methotrexate is used in maintenance therapy in combination with other chemotherapeutic agents. Methotrexate is used alone or ... Read more
Neoplastic Diseases: Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. Methotrexate is used in maintenance therapy in combination with other chemotherapeutic agents. Methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous T cell lymphoma), and lung cancer, particularly squamous cell and small cell types. Methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-Hodgkin's lymphomas.
Psoriasis: Methotrexate is indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation. It is important to ensure that a psoriasis “flare” is not due to an undiagnosed concomitant disease affecting immune responses.
Rheumatoid Arthritis Including Polyarticular-Course Juvenile Rheumatoid Arthritis: Methotrexate is indicated in the management of selected adults with severe, active, rheumatoid arthritis (ACR criteria), or children with active polyarticular course juvenile rheumatoid arthritis, who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).
Aspirin, NSAIDs, and/or low dose steroids may be continued, although the possibility of increased toxicity with concomitant use of NSAIDs including salicylates has not been fully explored. Steroids may be reduced gradually in patients who respond to methotrexate. Combined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine, or cytotoxic agents, has not been studied and may increase the incidence of adverse effects. Rest and physiotherapy as indicated should be continued.
","Antidote preparations, Immunosuppressant
","Methotrexate inhibits dihydrofolic acid reductase. Dihydrofolates must be reduced to tetrahydrofolates by this enzyme before they can be utilized as carriers of one-carbon groups in the synthesis of p.r.n. nucleotides and thymidylate. Therefore, methotrexate interferes with DNA synthesis, repair, and cellular replication. Actively proliferating tissues such as malignant cells, bone marrow, fetal cells, buccal and intestinal mucosa, and cells of the urinary bladder are in general more sensitive to this effect of methotrexate. When cellular proliferation in malignant tissues is greater than in most normal tissues, methotrexate may impair malignant growth without irreversible damage to normal tissues
","Oral-
+
+- Choriocarcinoma: 15-30 mg daily for 5 days, repeat after an interval of ≥1 wk for 3-5 courses.
+- Acute lymphoblastic leukaemia: Maintenance: 15 mg/m2 once or twice wkly, with other agents.
+- Burkitt's lymphoma: 10-25 mg daily for 4-8 days, repeated after 7-10 days.
+- Psoriasis: 10-25 mg wkly as a single dose, adjust subsequent doses based on response.
+- Rheumatoid arthritis: 7.5 mg once wkly, adjust by response. Not more than 20 mg/wk.
+- Mycosis fungoides: 2.5-10 mg daily to induce remission.
+- Crohn's disease: 12.5-22.5 mg once wkly for up to 1 yr.
+
+Parenteral-
+
+- Psoriasis: 10-25 mg wkly as a single dose. Adjust subsequent doses based on response. May be given via IV/IM admin.
+
+Intramuscular-
+
+- Choriocarcinoma: 15-30 mg daily for 5 days. Repeat after at least 1 wk for 3-5 courses. Alternatively, 0.25-1 mg/kg (max: 60 mg) every 48 hr for 4 doses followed by folinic acid rescue, repeat at intervals of 7 days for 4 or more courses.
+- Mycosis fungoides: 50 mg wkly as a single dose or 2 divided doses.
+- Acute lymphoblastic leukaemia: Maintenance: 15 mg/m2 once or twice wkly, with other agents.
+- Crohn's disease: 25 mg once wkly for 16 wk. Maintenance: 15 mg wkly.
+
+Intrathecal-
+
+- Meningeal leukaemia: 12 mg/m2 (max 15 mg) once wkly for 2-3 wk, then once mthly. Alternatively, 200-500 mcg/kg every 2-5 day until CSF cell count is normalised.
+
+Intravenous-
+
+- Osteosarcoma: Initial recommended dose: 12 g/m2 as a 4-hr infusion, followed by folinic acid, as part of combined therapy. May increase dose to 15 g/m2 in subsequent treatments if initial dosage is insufficient to achieve peak serum methotrexate levels of 454 mcg/mL at the end of the infusion. Methotrexate infusion is administered on postoperative wk 4, 5, 6, 7, 11, 12, 15, 16, 29, 30, 44 and 45; in combination with other chemotherapy agents. Folinic acid can be given orally, IM or IV inj starting 24 hr after the beginning of the methotrexate infusion. Give via parenteral routes If patient experiences GI toxicity (e.g., nausea, vomiting). Usual dosage of folinic acid: 15 mg every 6 hr for a total of 60 hr or a total of 10 doses.
+- Breast cancer: 10-60 mg/m2 often with cyclophosphamide and fluorouracil.
+- Advanced lymphosarcoma: Up to 30 mg/kg, followed by folinic acid rescue.
+- Acute lymphoblastic leukaemia: Maintenance: 2.5 mg/kg every 14 days.
+
","Should be taken on an empty stomach. Best taken on an empty stomach. May be taken with meals to reduce GI discomfort. Avoid taking with milk-rich products.
","Decreased effectiveness with folic acid and its derivatives.
","Severe renal or hepatic impairment, pre-existing profound bone marrow suppression in patients with psoriasis or rheumatoid arthritis, alcoholic liver disease, AIDS, pre-existing blood dyscrasias, pregnancy (in patients with psoriasis or rheumatoid arthritis), breast-feeding.
","Ulceration of the mouth and GI disturbances (e.g. stomatitis and diarrhoea), bone marrow depression, hepatotoxicity, renal failure, skin reactions, alopecia, ocular irritation, arachnoiditis in intrathecal use, megaloblastic anaemia, osteoporosis, precipitation of diabetes, arthralgias, necrosis of soft tissue and bone, anaphylaxis, impaired fertility.
","Pregnancy category X. Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
","Hepatic or renal impairment, bone marrow depression, elderly, neonates. Ulcerative disorders of the GI tract. Monitor haematological, renal and hepatic function, and GI toxicity regularly.
",,"Nausea, vomiting, alopecia, melena, and renal failure.
",,"Intramuscular: Dilute powder with D5W or normal saline to a concentration ≤25 mg/ml (20 mg and 50 mg vials) and 50 mg/ml (1 g vial).
Intrathecal: Reconstitute to 2.5-5 mg/ml with normal saline, D5W, lactated Ringer's, or Elliott's B solution. Use preservative-free preparations.
Intravenous: Dilute powder with D5W or normal saline to a concentration ≤25 mg/ml (20 mg and 50 mg vials) and 50 mg/ml (1 g vial).
Parenteral: Dilute powder with D5W or normal saline to a concentration ≤25 mg/ml (20 mg and 50 mg vials) and 50 mg/ml (1 g vial).
","Store at room temperature (15-25°C).
",13
+1393,Methocarbamol,methocarbamol-1393,https://medex.com.bd/attachments/i4813IwElVBalU9OHPVpuTLb98xjut/methocarbamol-prescribing-information,Centrally acting Skeletal Muscle Relaxants,Musculoskeletal pain,"Methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man
","Centrally acting Skeletal Muscle Relaxants
","Methocarbamol is a central muscle relaxant for skeletal muscles, used to treat spasms. It is structurally related to guaifenesin. Methocarbamol's exact mechanism of causing skeletal muscle relaxation is unknown. It is thought to work centrally, perhaps by general depressant effects. It has no direct relaxant effects on striated muscle, nerve fibers, or the motor endplate. It will not directly relax contracted skeletal muscles. The drug has a secondary sedative effect.
The mechanism of action of methocarbamol in humans has not been established, but may be due to general central nervous system (CNS) depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber.
","Methocarbamol 500 mg:
+
+- Initial dosage: 1500 mg (3 tablets) q.i.d.
+- Maintenance dosage: 2 tablets q.i.d.
+
+Methocarbamol 750 mg:
+
+- Initial dosage: 1500 mg (2 tablets) q.i.d.
+- Maintenance dosage: 1 tablet q.4h. or 2 tablets t.i.d.
+
+Six grams a day are recommended for the first 48 to 72 hours of treatment. (For severe conditions 8 grams a day may be administered). Thereafter, the dosage can usually be reduced to approximately 4 grams a day.
",,"Methocarbamol may inhibit the effect of pyridostigmine bromide. Therefore, methocarbamol should be used with caution in patients with myasthenia gravis receiving anticholinesterase agents.
","Methocarbamol is contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.
","Body as a whole: Anaphylactic reaction, angioneurotic edema, fever, headache
Cardiovascular system: Bradycardia, flushing, hypotension, syncope, thrombophlebitis
Digestive system: Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting
Hemic and lymphatic system: Leukopenia
Immune system: Hypersensitivity reactions
Nervous system: Amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo
Skin and special senses: Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria
","Pregnancy Category C. Animal reproduction studies have not been conducted with methocarbamol. It is also not known whether methocarbamol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. methocarbamol should be given to a pregnant woman only if clearly needed.
Safe use of methocarbamol has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, methocarbamol should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards
Nursing Mothers: Methocarbamol and/or its metabolites are excreted in the milk of dogs; however, it is not known whether methocarbamol or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Methocarbamol is administered to a nursing woman.
","Patients should be cautioned that methocarbamol may cause drowsiness or dizziness, which may impair their ability to operate motor vehicles or machinery. Because methocarbamol may possess a general CNS-depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants.
Since methocarbamol may possess a general CNS depressant effect, patients receiving methocarbamol should be cautioned about combined effects with alcohol and other CNS depressants. Safe use of methocarbamol has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, methocarbamol should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards
","Pediatric Use: Safety and effectiveness of Methocarbamol in pediatric patients below the age of 16 have not been established.
","Limited information is available on the acute toxicity of methocarbamol. Overdose of methocarbamol is frequently in conjunction with alcohol or other CNS depressants and includes the following symptoms: nausea, drowsiness, blurred vision, hypotension, seizures, and coma. In post-marketing experience, deaths have been reported with an overdose of methocarbamol alone or in the presence of other CNS depressants, alcohol or psychotropic drugs.
Management of overdose includes symptomatic and supportive treatment. Supportive measures include maintenance of an adequate airway, monitoring urinary output and vital signs, and administration of intravenous fluids if necessary. The usefulness of hemodialysis in managing overdose is unknown.
",,,"Store at controlled room temperature, between 20°C and 25°C
",12
+1870,Methimazole,methimazole-1870,https://medex.com.bd/attachments/ASh62bxcxg0MGTgTl7k0Q1LVv0Br06/methimazole-prescribing-information,Anti-thyroid drugs,Hyperthyroidism,"Methimazole is indicated:
+
+- In patients with Graves' disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option.
+- To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.
+
","Anti-thyroid drugs
","Methimazole inhibits the synthesis of thyroid hormones and thus is effective in the treatment of hyperthyroidism. The drug does not inactivate existing thyroxine and triiodothyronine that are stored in the thyroid or circulating in the blood nor does it interfere with the effectiveness of thyroid hormones given by mouth or by injection. Methimazole is readily absorbed in the gastrointestinal tract, metabolized in the liver, and excreted in the urine.
","Methimazole is administered orally. The total daily dosage is usually given in 3 divided doses at approximately 8 hour intervals.
Adults: The initial daily dosage is 15 mg for mild hyperthyroidism, 30 to 40 mg for moderately severe hyperthyroidism, and 60 mg for severe hyperthyroidism, divided into 3 doses at 8 hour intervals. The maintenance dosage is 5 to 15 mg daily.
Pediatric: Initially, the daily dosage is 0.4 mg/kg of body weight divided into 3 doses and given at 8 hour intervals. The maintenance dosage is approximately 1/2 of the initial dose.
Use in children & adolescents: Because of post-marketing reports of severe liver injury in pediatric patient treated with propylthiouracil, Methimazole is the preferred choice when an antithyroid drug is required for a pediatric patient.
",,"With medicine: Anticoagulants (oral)- Due to potential inhibition of vitamin K activity by methimazole, the activity of oral anticoagulants (e.g., warfarin) may be increased; additional monitoring of PT/INR should be considered, especially before surgical procedures. β-adrenergic blocking agents- Hyperthyroidism may cause an increased clearance of beta-blockers with a high extraction ratio. A dose reduction of beta-adrenergic blockers may be needed when a hyperthyroid patient becomes euthyroid. Digitalis glycosides- Serum digitalis levels may be increased when hyperthyroid patients on a stable digitalis glycoside regimen become euthyroid; a reduced dosage of digitalis glycosides may be needed. Theophylline- Theophylline clearance may decrease when hyperthyroid patients on a stable theophylline regimen become euthyroid; a reduced dose of theophylline may be needed.
With food: Always take at the same moment in regard to meals, food may affect absorption unpredictably.
","Methimazole is contraindicated in the presence of hypersensitivity to the drug or any of the other product components.
","Common: Skin rash, urticaria, nausea, vomiting, epigastric distress, arthralgia, paresthesia, loss of taste, abnormal loss of hair, myalgia, headache, pruritus, drowsiness, neuritis, edema, vertigo, skin pigmentation, jaundice, sialadenopathy, and lymphadenopathy.
Rare: Agranulocytosis, granulocytopenia, thrombocytopenia and aplastic anemia, drug fever, a lupus-like syndrome, insulin autoimmune syndrome (which can result in hypoglycemic coma), hepatitis (jaundice may persist for several weeks after discontinuation of the drug), periarteritis, and hypoprothrombinemia. Nephritis occurs very rarely.
","Pregnancy Category D. Due to the rare occurrence of congenital malformations associated with methimazole use, it may be appropriate to use other agents in pregnant women requiring treatment for hyperthyroidism particularly in the first trimester of pregnancy. Methimazole is excreted into breast milk. However, several studies found no effect on clinical status in nursing infants of mothers taking methimazole, particularly if thyroid function is monitored at frequent (weekly or biweekly) intervals.
","Congenital Malformations: Methimazole readily crosses the placental membranes and can cause fetal harm, particularly when administered in the first trimester of pregnancy. If Methimazole is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be warned of the potential hazard to the fetus. Since some congenital defects have been reported in offspring of patients treated with Methimazole, it may be appropriate to use other agents in pregnant women requiring treatment for hyperthyroidism, particularly in the first trimester of pregnancy. If Methimazole is used, the lowest possible dose to control the disease should be given.
Agranulocytosis: Agranulocytosis is potentially a life-threatening adverse reaction of Methimazole therapy. Patients should be instructed to immediately report to their physicians if any symptoms suggestive of agranulocytosis, such as fever or sore throat occur. Leukopenia, thrombocytopenia, and aplastic anemia (pancytopenia) may also occur. The drug should be discontinued in the presence of agranulocytosis, aplastic anemia (pancytopenia), ANCA-positive vasculitis, hepatitis, or exfoliative dermatitis and the patient’s bone marrow indices should be monitored.
Liver Toxicity: Although there have been reports of hepatotoxicity associated with Methimazole, the risk of hepatotoxicity appears to be less with methimazole than with propylthiouracil, especially in the pediatric population. Drug treatment should be discontinued promptly in the event of clinically significant evidence of liver abnormality including hepatic transaminase values exceeding 3 times the upper limit of normal.
Hypothyroidism: Methimazole can cause hypothyroidism necessitating routine monitoring of TSH and free T4 levels with adjustments in dosing to maintain a euthyroid state. Because the drug readily crosses placental membranes, Methimazole can cause fetal goiter and cretinism when administered to a pregnant woman. For this reason, it is important that a sufficient, but not excessive, dose be given during pregnancy. Because Methimazole may cause hypoprothrombinemia and bleeding, prothrombin time should be monitored during therapy with the drug, especially before surgical procedures. Thyroid function tests should be monitored periodically during therapy. Once clinical evidence of hyperthyroidism has resolved, the finding of a rising serum TSH indicates that a lower maintenance dose of Methimazole should be employed.
",,"Symptoms may include nausea, vomiting, epigastric distress, headache, fever, joint pain, pruritus, and edema. Aplastic anemia or agranulocytosis may be manifested in hours to days. Less frequent events are hepatitis, nephrotic syndrome, exfoliative dermatitis, neuropathies, and CNS stimulation or depression. In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient’s medical status.
",,,"Store in a cool (below 30°C) and dry place, away from light and children.
",11
+1848,Methenamine Hippurate,methenamine-hippurate-1848,https://medex.com.bd/attachments/9vX8h8ZowuYhW3YxtXkgL4qnbbk4us/methenamine-hippurate-prescribing-information,Other genito-urinary preparations,Urinary tract infection,"Methenamine is indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary. This drug should only be used after eradication of the infection by other appropriate antimicrobial agents. To reduce the development of ... Read more
Methenamine is indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary. This drug should only be used after eradication of the infection by other appropriate antimicrobial agents. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Methenamine and other antibacterial drugs, Methenamine should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
","Other genito-urinary preparations
","Methenamine Hippurate has antibacterial activity because the methenamine component is hydrolyzed to formaldehyde in acid urine. Hippuric acid, the other component, has some antibacterial activity and also acts to keep the urine acid. The drug is generally active against E. coli, enterococci and staphylococci. Enterobacter aerogenes is generally resistant. The urine must be kept sufficiently acid for urea-splitting organisms such as Proteus and Pseudomonas to be inhibited.
Pharmacology: Within 1/2 hour after ingestion of a single 1-gram dose of Methenamine, antibacterial activity is demonstrable in the urine. Urine has continuous antibacterial activity when HIPREX is administered at the recommended dosage schedule of 1 gram twice daily. Over 90% of methenamine moiety is excreted in the urine within 24 hours after administration of a single 1-gram dose. Similarly, the hippurate moiety is rapidly absorbed and excreted, and it reaches the urine by both tubular secretion and glomerular filtration. This action may be important in older patients or in those with some degree of renal impairment.
","For adults and pediatric patients over 12 years of age: 1 tablet twice daily (morning and night).
For pediatric patients 6 to 12 years of age: ½ to 1 tablet twice daily (morning and night).
Since the antibacterial activity of Methenamine is greater in acid urine, restriction of alkalinizing foods and medications is desirable. If necessary, as indicated by urinary pH and clinical response, supplemental acidification of the urine should be instituted. The efficacy of therapy should be monitored by repeated urine cultures.
",,,"Methenamine Hippurate tablets USP is contraindicated in patients with renal insufficiency, severe hepatic insufficiency, or severe dehydration. Methenamine preparations should not be given to patients taking sulfonamides because some sulfonamides may form an insoluble precipitate with formaldehyde in the urine.
",,"In early pregnancy the safe use of Methenamine is not established. In the last trimester, safety is suggested, but not definitely proved. No adverse effects on the fetus were seen in studies in pregnant rats and rabbits. Methenamine taken during pregnancy can interfere with laboratory tests of urine estriol (resulting in unmeasurably low values) when acid hydrolysis is used in the laboratory procedure. This interference is due to the presence in the urine of methenamine and/or formaldehyde. Enzymatic hydrolysis, in place of acid hydrolysis, will circumvent this problem.
","Prescribing Methenamine in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Care should be taken to maintain an acid pH of the urine, especially when treating infections due to urea-splitting organisms such as Proteus and strains of Pseudomonas.
In a few instances in one study, the serum transaminase levels were slightly elevated during treatment but returned to normal while the patients were still taking Methenamine. Because of this report, it is recommended that liver function studies be performed periodically on patients taking the drug, especially those with liver dysfunction.
","Geriatric Use: Clinical studies of Methenamine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Renal insufficiency and severe hepatic insufficiency: Methenamine is contraindicated in patients with renal insufficiency and severe hepatic insufficiency.
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+734,Metformin Hydrochloride,metformin-hydrochloride-734,https://medex.com.bd/attachments/rKuJgq84xVkvsnkO32epweL1Rs6Eax/metformin-hydrochloride-prescribing-information,Biguanides,Type 2 DM,"Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary management and exercise alone does not result in adequate glycaemic control.
+
+- In adults: Metformin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
... Read more
Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary management and exercise alone does not result in adequate glycaemic control.
+
+- In adults: Metformin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
+- In children from 10 years of age and adolescents: Metformin may be used as monotherapy or in combination with insulin.
+
+A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure.
","Biguanides
","Metformin is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
","Metformin immediate release tablet: Dosage of Metformin Hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses.
+
+- Adult: The usual starting dose of Metformin is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. For those patients requiring additional glycemic control, Glucomin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
+- Children: The usual starting dose of Metformin is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.
+
+
Metformin extended release tablet: Swallow Metformin XR tablet whole and never crush, cut or chew.
+
+- Adult: The usual starting dose of Metformin XR is 500 mg once daily with the evening meal. Dose should be increased in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal, alternatively increased to 1000 mg twice daily taken with meal. Patient receiving Metformin immediate release tablet may be switched to Metformin extended release tablet up to a maximum recommended daily dose.
+- Children: Metformin extended release tablet has not been studied in children.
+- Renal impaired patient: Do not use Metformin in patients with eGFR below 30 mL/min/1.73 m2. Asses risk/benefit of counting if eGFR falls below 45 mL/min/1.73 m2.
+
",,"Co-administration with Carbonic anhydrase (Topiramate, Zonisamide) may increase risk of lactic acidosis. Drugs (Ranolazine, Dolutegravir, Cimetidine) that reduce Metformin clearance may increase the accumulation of Metformin. Alcohol can potentiate the effect of Metformin on lactate metabolism.
","
+- Hypersensitivity to the active substance or to any of the excipients.
+- Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
+- Severe renal failure (GFR <30 mL/min).
+- Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
+- Acute or chronic disease, which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock, Hepatic insufciency, acute alcohol intoxication, alcoholism.
+
","Blood and lymphatic system disorders: Not known: Hemolytic anemia
Metabolism and nutrition disorders: Very rare: Lactic acidosis. Decrease of vitamin B12 absorption with a decrease of serum levels during long-term use of metformin. Consideration of such etiology is recommended if a patient presents with megaloblastic anemia. Cases of peripheral neuropathy in patients with vitamin B12 deficiency have been reported in post-marketing experience (frequency not known)
Nervous system disorders: Common: Taste disturbance. Not known: Encephalopathy
Gastrointestinal disorders: Very common: Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These undesirable effects occur most frequently during the initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.
Hepatobiliary disorders: Very rare: Isolated reports of liver function test abnormalities or hepatitis resolving upon metformin discontinuation.
Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.
","Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with an increased risk of congenital abnormalities and perinatal mortality. When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus.
Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.
","Metformin Hydrochloride is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Metformin may lower vitamin B12 level. It also increases risk of hypoglycemia when use in combination with insulin or insulin secretagogue.
","Elderly: Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.
Pediatric population: The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated. No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially prepubescent children, is recommended.
Children aged between 10 and 12 years: Particular caution is recommended when prescribing to children aged between 10 and 12 years.
Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:
+
+- At least annually in patients with normal renal function,
+- At least two to four times a year in patients with creatinine clearance at the lower limit of normal and in elderly subjects.
+
+Decreased renal function in elderly subjects is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug (NSAID). GFR should be assessed before treatment initiation and regularly thereafter. Metformin is contraindicate in patients with GFR<30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function.
","Hypoglycemia has not been seen with Metformin doses up to 85 gm, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and Metformin is hemodialysis.
",,,"Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.
",12
+733,Mesna,mesna-733,https://medex.com.bd/attachments/1hIxK9ajVis85H5u7aUDKXOsnPTMfB/mesna-prescribing-information,Antidote preparations,Urothelial toxicity,"Mesna is a cytoprotective agent indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis.
","Antidote preparations
","Mesna is used to prevent urothelial toxicity associated with oxazaphosphorine, ifosfamide or cyclophosphamide. It acts in the kidney; reacting with thiol groups of urotoxic metabolites (e.g. acrolein) of ifosfamide and cyclophosphamide. It is used as a mucolytic in the management of some respiratory tract conditions e.g. cystic fibrosis where other mucolytics have failed. It acts by reducing the viscosity of pulmonary secretions; the drug's free sulfhydryl group is thought to reduce disulfide linkages of mucoproteins.
","Intravenous-
Prophylaxis against urothelial toxicity:
+
+- Adult: Refer to individual and local protocol. Dose calculated according to cytotoxic dose. Normally given at a dose ≥cytotoxic dose. Duration of treatment should be as long as cytotoxic treatment; plus the time it takes for concentration of antineoplastic metabolites in urine to fall. Administered either by short (15-30 minutes) or continuous (24 hr) infusion.
+- Child: Refer to individual and local protocol. Has been used in children >4 mth.
+
+Oral-
Prophylaxis against urothelial toxicity:
+
+- Adult: Refer to individual and local protocol. Dose calculated according to cytotoxic dose. Normally given at a dose ≥cytotoxic dose. Duration of treatment should be as long as cytotoxic treatment; plus the time it takes for concentration of antineoplastic metabolites in urine to fall.
+- Child: Refer to individual and local protocol.
+
",,,"Hypersensitivity to thiol-containing compounds.
","Nausea, vomiting, colic, diarrhoea, anorexia, dyspepsia, unpleasant taste, constipation; headache, malaise, fatigue, depression, irritability, somnolence, hyperaesthesia, dizziness, confusion; rash, pruritus, generalised urticaria, alopecia, inj site reactions, flushing; leucopenia, thrombocytopenia, anaemia, granulocytopenia, chest pain, oedema (peripheral, facial and periorbital), hypotension, tachycardia, hypertension, increased heart rate, ST-segment elevation; dyspnoea, coughing, pneumonia, tachypnea; fever; hypocalcaemia; increased sweating; back pain, limb pain, myalgia; increased hepatic enzyme concentrations; pharyngitis; ulceration of mucous membranes. In patients receiving oral and/or IV mesna and were specifically not treated with concurrent cytotoxic therapy: flatulence; rhinitis; rigors; back pain; rash; conjunctivitis; arthralgia. Inhalation: bronchospasm.
","Pregnancy Category B. Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
","Protective effect applies only to the urinary tract; pregnancy, lactation. Patients with auto-immune disorders. IV formulation may contain benzyl alcohol as a preservative; avoid in neonates or infants. Instruct patients to seek medical attention if discolouration of urine occurs. During treatment, monitor urine for erythrocytes and haematuria. Maintain adequate hydration in all patients. Patients who vomit within 2 hr of oral dose should repeat dose or receive IV dose.
",,,,"Dilute in 50-1000 ml normal saline, 5% dextrose or lactated Ringer's.
","Should be stored at 15-30° C.
",10
+4,Mesalazine [5-aminosalicylic acid],mesalazine-5-aminosalicylic-acid-4,https://medex.com.bd/attachments/1pUwoQO0X41RqH38LSQjRkkNcPLufo/mesalazine-5-aminosalicylic-acid-tablet-prescribing-information,Aminosalicylates,Ulcerative colitis,"Mesalazine is indicated for
+
+- Treatment of mild to moderately active Ulcerative Colitis & & Crohn’s Disease
+- Maintenance of remission of Ulcerative Colitis
+- Maintenance of remission of Crohn’s disease
+
","Aminosalicylates
","The mechanism of action of Mesalamine is unknown, but appears to be topical rather than systemic. Mucosal production of Arachidonic Acid metabolites, both through the cyclooxygenase pathways, that is, prostanoids, and through the lipoxygenase pathways, that is, leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with chronic infammatory bowel disease. Mesalamine diminishes infammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.
","Ulcerative colitis-
Adults:
+
+- Active disease: Individual dosage, up to 4 gm mesalazine once daily or divided into 2-4 doses.
+- Maintenance treatment: Individual dosage. Recommended dosage, 2 gm mesalazine once daily.
+
+
Pediatrics: The safety and efficacy in children below 6 years of age have not been established. There is only limited documentation for an effect in children (age 6-18 years).
Children 6 years of age and older:
+
+- Active disease: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day (maximum adult dose).
+- Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed 2 g/day (recommended adult dose).
+- It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg.
+
","The granules must not be chewed. The contents of the sachet should be emptied onto the tongue and washed down with some water or orange juice. Alternatively, the entire content of the sachet can be taken with yogurt and consumed immediately.
","Concurrent use of other known nephrotoxic agents such as NSAIDs and Azathioprine may increase the risk of renal reactions.
","Hypersensitivity to salicylates or to any other component of the formulation.
","The commonly reported adverse events are headache, nausea, dizziness, asthenia, dyspepsia, vomiting, pruritus etc.
","It should be given in pregnancy only if the potential beneft justifes the potential risk to the fetus. Caution is advised when it is administered to a nursing mother.
","Patients with pyloric stenosis may have prolonged gastric retention of Mesalamine tablets which could delay release of Mesalamine in the colon. Renal impairment, including minimal change nephropathy and acute and chronic interstitial nephritis has been reported in patients taking Mesalamine. Therefore, caution should be exercised when using Mesalamine in patients with known renal dysfunction or history of renal disease. Patients should have renal function monitored, prior to treatment start and then it should be monitored periodically during treatment. There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered Mesalamine. Caution should be exercised when administering Mesalamine to patients with liver impairment.
","Geriatrics: Patients who are 65 years or older, caution should be taken to closely monitor blood cell counts during Mesalamine therapy.
Elderly: Because elderly patients are more likely to have decreased renal function, care should be taken when prescribing this drug therapy. It is recommended that all patients have an evaluation of renal function prior to initiation of Mesalamine tablets. Monitor blood cell counts during drug therapy.
Paediatric: Safety and effectiveness have not been established.
","There is no specifc antidote for Mesalamine overdose. Treatment for suspected acute severe toxicity should be symptomatic and supportive. This may include prevention of further gastrointestinal tract absorption, correction of fuid electrolyte imbalance and maintenance of adequate renal function. This is a pH dependent delayed-release product and this factor should be considered when treating a suspected over dose.
",,,"Store below 30 0 C. Protect from light and moisture. Keep all medicines out of the reach of children.
",13
+731,Meropenem Trihydrate,meropenem-trihydrate-731,https://medex.com.bd/attachments/pYjhRDE2ZoSlmwadYnvdBg8XBXUBoQ/meropenem-trihydrate-prescribing-information,Other beta-lactam Antibiotics,Uncomplicated pneumococcal pneumonia,"Meropenem is indicated for treatment in adults and children for the following infections caused by single or multiple bacteria sensitive to Meropenem.
+
+- Pneumonia and Nosocomial Pneumonia
+- Urinary Tract Infections
+- Intra-abdominal Infections
+- Gynaecological Infections, such as endometritis and pelvic inflammatory disease
... Read more
Meropenem is indicated for treatment in adults and children for the following infections caused by single or multiple bacteria sensitive to Meropenem.
+
+- Pneumonia and Nosocomial Pneumonia
+- Urinary Tract Infections
+- Intra-abdominal Infections
+- Gynaecological Infections, such as endometritis and pelvic inflammatory disease
+- Skin and Skin Structure Infections
+- Meningitis
+- Septicaemia
+- Pulmonary infections in cystic fibrosis
+- Empiric treatment for presumed infections in patients with febrile neutropenia.
+
","Other beta-lactam Antibiotics
","Meropenem is a carbapenem antibiotic for parenteral use . It exerts its bactericidal action by interfering with bacterial cell wall synthesis. It penetrates bacterial cell walls, its high level of stability to all serine beta-lactamases and its marked affinity for the Penicillin Binding Proteins (PBPs.). It shows potent bactericidal activity against a broad spectrum of Gram-positive and Gram-negative, aerobic and anaerobic bacteria.
","The dosage and duration of therapy shall be established depending on type, severity of infection and the condition of the patient. The recommended daily dosage is as follows-
Adults:
+
+- The usual dose is 500 mg to 1 gm by intravenous administration every 8 hours.
+- Pneumonia, urinary tract infections, gynaecological infections such as endometritis, pelvic inflammatory disease, skin and skin structure infections: 500 mg IV every 8 hours.
+- Nosocomial pneumonias, peritonitis, presumed infections in neutropenic patients and septicaemia: 1 g IV every 8 hours.
+- Intra-abdominal infections: 500 mg to 1 gm every 8 hours.
+- Cystic fibrosis: Upto 2 gm every 8 hours.
+- Meningitis: 2 gm IV every 8 hours.
+
+Children:
+
+- 3 months to 12 years: 10 to 40 mg/kg intravenously every 8 hours depending on type and severity of infection, susceptibility of the pathogens and the condition of the patient.
+- Intra-abdominal infections: 20 mg/kg every 8 hours.
+- Cystic fibrosis (4-18 years): 25-40 mg/kg every 8 hours.
+- Meningitis: 40 mg/kg IV every 8 hours.
+- Febrile neutropenia: 20 mg/kg every 8 hours.
+- Children over 50 kg weight: use adult dosage.
+- There is no experience in children with hepatic or renal impairment.
+
","Meropenem should be administered by intravenous Infusion over approximately 15-30 minutes or as intravenous bolus (5 to 20 ml) over approximately 3-5 minutes
","Probenecid competes with Meropenem for active tubular secretion and thus inhibits the renal excretion, with the effect of increasing the elimination half-life and plasma concentration of meropenem. Meropenem may reduce serum valproic acid levels. Sub therapeutic levels may be reached in some patients.
","Meropenem is contraindicated in patients who have demonstrated hypersensitivity to this product.
","Meropenem is generally well tolerated. Side effects like inflammation, thrombophlebitis, pain at the site of injection, skin reactions like rash, pruritus, urticaria, abdominal pain, nausea, vomiting, diarrhea, headache may occur.
","Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. So this drug should be used during pregnancy only if clearly needed. Because many drugs are excreted in human milk, caution should be exercised when Meropenem is administered to a nursing woman.
","If an allergic reaction to Meropenem occurs, the drug should be discontinued and appropriate measures taken. Use of Meropenem in patients with hepatic disease should be made with careful monitoring of transaminase and bilirubin levels.
","Renal impairment: Dosage should be reduced in patients with creatinine clearance less than 51 ml/min.
Hepatic impairment: No dosage adjustments are necessary with impairment of liver function. Hemodialysis patients should receive Meropenem after dialysis has been completed.
Elderly: No dosage adjustments are necessary in elderly patients unless creatinine clearance is <51 ml/min.
Use in Children: Efficacy and tolerability in infants under 3 months have not been established.
","Accidental overdose could occur during therapy, particularly in patients with renal impairment. Treatment of overdose should be symptomatic. In normal individuals, rapid renal elimination will occur; in subjects with renal impairment, haemodialysis will remove Meropenem and its metabolite.
",,"Preparation of solution:
Intravenous bolus Administration: Reconstitute Meropenem (500 mg or 1 g) with sterile water for injection. Shake to dissolve and to obtain solution which is clear and colorless or pale yellow.
Intravenous infusion administration: Meropenem for intravenous infusion may be directly constituted with a compatible infusion fluid and then further diluted (50 to 200 ml) with the compatible infusion fluid, as needed.
Meropenem is compatible with the following infusion fluids: 0.9% sodium chloride intravenous infusion, 5% or 10% glucose intravenous infusion, 5% glucose intravenous infusion with 0.02% sodium bicarbonate, 5% glucose and 0.9% sodium chloride intravenous infusion, 5% glucose with 0.225% sodium chloride intravenous infusion, 5% glucose with 0.15% potassium chloride intravenous infusion, 2.5% and 10% mannitol intravenous infusion, normosol-M in 5% glucose intravenous infusion.
The use of freshly reconstituted solution is recommended. However, it maintains potency for up to 3 hours at up to 25oC or 13 hours at up to 5oC
","Vial store in a cool, dry place (below 30oC), away from light & moisture. Keep out of the reach of children.
",14
+765,Mitomycin C,mitomycin-c-765,https://medex.com.bd/attachments/1hQhGICBncKy4ZlJq08RzdSODG5fUf/mitomycin-c-prescribing-information,Cytotoxic Chemotherapy,Urothelial bladder carcinoma,"This is indicated in Diabetic foot infections; Chronic lymphatic leukaemia; Chronic myelogenous leukaemia; Gastric, Colorectal, Lung, Pancreatic, Cervix, Endometrium, Breast, Bladder, Head & neck carcinoma.
","Cytotoxic Chemotherapy
","Mitomycin is an antineoplastic antibiotic which is enzymatically reduced to its active metabolite within susceptible cells. The active metabolite appears to cause cross-linking of DNA (primarily with guanine and cytosine pairs). It is also active against gm+ve bacteria and some viruses.
","Solid tumours Suggested regimen: Initial: 10-20 mg/m2; may repeat 6-8 wkly depending on blood count. Do not repeat if leucocyte and platelet counts are below acceptable levels. Do not re-administer if the nadir of the leucocyte count is <2,000 cells/mm3
Intravesical Superficial bladder tumours: Instill 10-40 mg 1 -3 times/wk for a total of 20 doses
Prevention of recurrent bladder tumours: Instill 20 mg 2 wkly or 40 mg 1-3-mthly.
",,"Increased incidence of cardiotoxicity with doxorubicin.
","Hypersensitivity. Patient with platelet counts <100,000/mm3, leukocyte counts <4,000/mm3 or serum creatinine concentration >1.7 mg/dL. Patient with substantial prolongation of prothrombin time or bleeding time, coagulation disorders, increased bleeding tendency. Pregnancy and lactation.
","Hemolytic uremic syndrome (<15%), Myelosuppression (64%), Nausea/ vomiting (14%), Fever (14%), Stomatitis (4%), Increased serum creatinine (2%), Mucous membrane toxicity (4%) , Fatigue, Pulmonary toxicity, Dyspnea, Cystitis, Interstitial fibrosis, Nephrotoxicity, Amenorrhea, Alopecia, Myelosuppression, haemolytic-uraemic syndrome.
","Pregnancy category- D
","Repeated haematologic studies are necessary during treatment and for at least 7 wk after discontinuation of the drug. Discontinue use when the leucocyte count decreases to <4000/mm3 or the platelet count decreases to <150,000/mm3 or if a progressive decline in either occurs. Monitor patient for signs of renal or pulmonary toxicity.
",,,,"Intravenous: Reconstitute by adding 10, 40 or 80 mL of sterile water for inj to a vial labeled as containing 5, 20, or 40 mg respectively, to provide a soln containing approx 0.5 mg/mL. The vial should be shaken to enhance dissolution. If the powd for inj does not dissolve immediately, allow the vial to stand at room temp until complete dissolution occurs.
","Powder for injection: Store between 15-30°C. Protect from light.
Reconstituted solution: Stable for 1 wk when stored between 15-25°C and 2 wk when stored between 2-8°C.
",11
+764,Misoprostol,misoprostol-764,https://medex.com.bd/attachments/vw5tnI9JZWOub0W4g2i9r5v9hHjBIR/misoprostol-prescribing-information,Prostaglandin analogues,Gastric and duodenal ulceration,"Misoprostol is indicated for-
+
+- Prophylaxis of gastric and duodenal ulceration in NSAID users at high risk of complications from gastric ulcer e.g. the elderly, patients with concomitant debilitating disease and patients with a history of ulcer.
+- Healing of established NSAID- induced gastric and duodenal damage.
... Read more
Misoprostol is indicated for-
+
+- Prophylaxis of gastric and duodenal ulceration in NSAID users at high risk of complications from gastric ulcer e.g. the elderly, patients with concomitant debilitating disease and patients with a history of ulcer.
+- Healing of established NSAID- induced gastric and duodenal damage.
+- Healing of gastric and duodenal ulcers in the absence of NSAID therapy.
+- Induction of labor.
+- Prevention and treatment of postpartum hemorrhage.
+
","Drugs acting on the Uterus, Prostaglandin analogues
","Misoprostol is extensively absorbed, and undergoes rapid de-esterification to its free acid, which is responsible for its clinical activity and, unlike the parent compound, is detectable in plasma. Maximum plasma concentrations of Misoprostol acid are diminished when the dose is taken with food and total availability of Misoprostol acid is reduced by use of concomitant antacid. Misoprostol has both antisecretory (inhibiting gastric acid secretion) and (in animals) mucosal protective properties. NSAIDs inhibit prostaglandin synthesis, and a deficiency of prostaglandins within the gastric mucosa may lead to diminishing bicarbonate and mucus secretion and may contribute to the mucosal damage caused by these agents. Misoprostol can increase bicarbonate and mucus production, but in man this has been shown at doses 200 meg and above that are also antisecretory. It is therefore not possible to tell whether the ability of Misoprostol to reduce the risk of gastric ulcer is the result of its antisecretory effect, its mucosal protective effect, or both.
","Benign gastric and duodenal ulceration and NSAID associated ulceration: 800 mcg daily (in 2-4 divided doses) with breakfast or main meals and at bedtime; treatment should be continued for at least 4 weeks and may be continued for up to 8 weeks if required.
Prophylaxis of NSAID-induced gastric and duodenal ulcer: 200 mcg 2-4 times daily taken with NSAID. If this dose cannot be tolerated, a dose of 100 mcg can be used. Misoprostol should be taken for the duration of NSAID therapy as prescribed by the physician.
Induction of labor: Place 25 mcg in the posterior fornix of the vagina. Repeat after every 6 hours if necessary until the maximum dosage of 200 mcg total misoprostol is reached. Fetal heart rate and uterus contractions should be monitored. Alternatively, 100 mcg taken orally. If cervical ripening or active labor does not occur, repeated dose of 100-200 mcg of oral misoprostol is given every 4 hourly until labor is established (as evidenced by a Bishop score of 7 or more). Maximum number of dose is 6. Maternal vital signs, fetal heart rate and contractions should be monitored. Oxytocin can be started 4 hours after last dose of misoprostol. Physician should be notified for signs of fetal distress or tetanic uterine contractions. Oral misoprostol therapy should be monitored by Physician.
Prevention of postpartum hemorrhage: 600 mcg orally immediately following delivery.
Treatment of postpartum hemorrhage: 600 mcg orally or 1000 mcg per rectally.
",,"There is no evidence of clinically significant interaction between Misoprostol and cardiac, pulmonary, CNS drugs and NSAID's. The bioavailability of Misoprostol is decreased with high doses of antacid.
","Misoprostol is contraindicated to anyone with a history of allergy to prostaglandins and it is also contraindicated in pregnancy.
","Generally, Misoprostol is well tolerated. The most frequent adverse effects associated with Misoprostol therapy involve the GI tract such as diarrhea, abdominal pain, dyspepsia, flatulence, nausea, vomiting, rashes and dizziness. The incidence of diarrhea may be minimized by administering the drug after meal and at bedtime and by avoiding concomitant administration with a magnesium-containing or other laxative antacid.
","Because of the abortifacient property of the Misoprostol component, it is contraindicated in women who are pregnant. It should not be used in women of childbearing potential unless the patient requires nonsteroidal anti-inflammatory drug (NSAID) therapy and is at high risk of developing gastric or duodenal ulceration or for developing complications from gastric or duodenal ulcers associated with the use of the NSAID. In such patients, it may be prescribed if the patient:
+
+- has had a negative serum pregnancy test within 2 weeks prior to beginning therapy.
+- is capable of complying with effective contraceptive measures.
+- has received both oral and written warnings of the hazards of Misoprostol, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake.
+- will begin it only on the second or third day of the next normal menstrual period.
+
+Excretion of the active metabolite (Misoprostol acid) into milk is possible but has not been studied. Because of the potential for serious adverse reactions in nursing infants, it is not recommended for use by nursing mothers.
","In case of prevention and treatment of NSAID induced gastric and duodenal ulcer: Misoprostol is contraindicated in women who are pregnant, and should not be used in women of child bearing potential unless the patient requires NSAID therapy. Women of child bearing potential should be told that they must not be pregnant when Misoprostol therapy is initiated and they must use an effective contraception method while taking misoprostol.
In case of induction of labor: The pregnancy should have completed 38 weeks gestation by reliable dating, or lung maturity as evidenced by a L/S >2.0 or a positive phosphotidyl glycerol test, or completed 36 weeks gestation with a maternal or fetal medical indication for induction of labor. Induction of labor is contraindicated in acute fetal distress, abruptio placenta, placenta previa or unexplained vaginal bleeding. The fetus should be in vertex presentation.
","Use in children: Safety and effectiveness of Misoprostol in children below the age of 18 years have not been established.
","The toxic dose of Misoprostol in human has not been determined. Clinical signs that may indicate an overdose are a sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea and fever. Symptoms should be treated with supportive therapy.
",,,"Store in a cool and dry place, protected from light and moisture. Keep out of the reach of the children.
",12
+763,Mirtazapine,mirtazapine-763,https://medex.com.bd/attachments/wSsXpFdMN7OtTZwz963C5oTNSrlrlg/mirtazapine-prescribing-information,Atypical anti-depressant drugs,Major depressive disorder,"Mirtazapine Tablets are indicated for the treatment of major depressive disorder (MDD).
","Atypical anti-depressant drugs
","Pharmacodynamics: The mechanism of action of Mirtazapine as with other drugs effective in the treatment of major depressive disorder is unknown. Evidence gathered in preclinical studies suggests that Mirtazapine enhances central noradrenergic and serotonergic activity. These studies have shown that Mirtazapine acts as an antagonist at central presynaptic α2-adrenergic inhibitory autoreceptors and heteroreceptors, an action that is postulated to result in an increase in central noradrenergic and serotonergic activity. Mirtazapine is a potent antagonist of 5- HT2 and 5-HT3 receptors. Mirtazapine has no significant affinity for the 5-HT1A and 5-HT1B receptors. Mirtazapine is a potent antagonist of histamine (H1) receptors, a property that may explain its prominent sedative effects. Mirtazapine is a moderate peripheral α1-adrenergic antagonist, a property that may explain the occasional orthostatic hypotension reported in association with its use. Mirtazapine is a moderate antagonist at muscarinic receptors, a property that may explain the relatively low incidence of anticholinergic side effects associated with its use.
Pharmacokinetics: After oral administration of Mirtazapine tablets, the active constituent mirtazapine is rapidly and well-absorbed, reaching peak plasma levels after about 2 hours. Binding of mirtazapine to plasma proteins is approximately 85%. The mean half-life of elimination is 20-40 hours; (26 hours in males, 37 hours in females). The half-life of elimination is sufficient to justify once-a-day dosing. Mirtazapine displays linear pharmacokinetics within the recommended dose range. Mirtazapine is extensively metabolized and eliminated via the urine and faeces four days. Major pathways of biotransformation are demethylation and oxidation followed by conjugation.
","Adult dose: The recommended starting dose for Mirtazapine tablets is 15 mg/day, administered in a single dose, preferably in the evening or prior to sleep. The effective dose range was generally 15 to 45 mg/day and the patients not responding to the initial 15 mg dose may benefit from dose increases up to a 30 mg to maximum of 45 mg/day. Mirtazapine has an elimination half-life of approximately 20 to 40 hours; therefore, dose changes should be made at intervals of less than 1 to 2 weeks in order to allow sufficient time for the therapeutic response to a given dose.
Use in children: Use in children are not recommended to Mirtazapine.
Missed Dose: If anyone misses a dose of mirtazapine, take it as soon as remember unless it is close to when the next dose is due. If anyone missed a dose of medication and it is close to the time of next dose, skip the missed dose and should take next dose at the regularly scheduled time. One should not take double or more than prescribed dose.
",,"Mirtazapine has clinically significant drug-drug interactions with Monoamine Oxidase Inhibitors (MAOI) & other serotonergic drugs such as tryptophan, triptans, linezolid, serotonin reuptake inhibitors, venlafaxine, lithium, tramadol, or St. John's wort. Mirtazapine may interrupt the metabolism or activity of Carbamazepine, Phenytoin or Cimetidine. Patient should avoid Alcohol & Diazepam while taking Mirtazapine.
","Hypersensitivity: Mirtazapine is contraindicated in patients with a known hypersensitivity to Mirtazapine or to any of the excipients.
Monoamine Oxidase Inhibitors: The concomitant use of Mirtazapine and a monoamine oxidase (MAO) inhibitor is contraindicated. Mirtazapine should not be used within 14 days of initiating or discontinuing therapy with a monoamine oxidase inhibitor (MAOI).
","The most common side effects of Mirtazapine are dizziness, drowsiness, dry mouth, increased appetite, weight gain etc.
","Pregnancy Category-C. Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during Mirtazapine therapy. Patients should be advised to notify their physician if they are breastfeeding an infant.
","Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Patients who are to receive Mirtazapine should be warned about the risk of developing agranulocytosis. Mirtazapine may impair judgment, thinking, and particularly, motor skills, because of its prominent sedative effect. Clinically significant ALT (SGPT) elevations (≥3 times the upper limit of the normal range) may occur.
",,,,,"Keep away from light and moisture. Store below 30º C. Keep all medicine out of the reach of children.
",10
+762,Mirabegron,mirabegron-762,https://medex.com.bd/attachments/HLJ14Scj6b22dXcpqvTIEjDphQGjvX/mirabegron-prescribing-information,BPH/ Urinary retention/ Urinary incontinence,Urinary frequency and urgency,"Mirabegron is indicated for the symptomatic treatment of urgency, increased micturition frequency and urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome.
","BPH/ Urinary retention/ Urinary incontinence
","Mirabegron is the first beta-3 adrenoceptor agonist. Mirabegron exerts its effect via a dual mechanism, both directly acts on the bladder smooth muscle and also via the sensory nervous system, it increases the levels of cyclic adenosine monophosphate (cyclic AMP) and leads to relaxation of the detrusor smooth muscle during storage phase of urinary bladder fill-void cycle by activation of beta-3 adrenoceptor which increase bladder capacity.
","Adults including elderly: The recommended starting dose is Mirabegron 25 mg tablet once daily with or without food. Based on individual patient efficacy and tolerability the dose may be increased to Mirabegron 50 mg tablet once daily.
Renal or hepatic impairment:
+
+- Patients with severe renal impairment (ClCr 15 to 29 mL/min or eGFR 15 to 29 mL/min/1.73 m2) or moderate hepatic impairment (Child-Pugh Class B), the daily dose of Mirabegron should not exceed 25 mg tablet once daily.
+- Mirabegron has not been studied in patients with end stage renal disease (GFR <15 mL/min/1.73 m2 or patients requiring haemodialysis) or severe hepatic impairment (Child Pugh Class C) and it is therefore not recommended for use in these patient populations.
+
+
Gender: No dose adjustment is necessary according to gender.
Paediatric population: The safety and efficacy of Mirabegron in children below 18 years of age have not yet been established.
","Mirabegron tablet is to be taken once daily, with liquids, swallowed whole and is not to be chewed, divided, or crushed.
","Effect of enzyme inhibitors: Mirabegron exposure (AUC) was increased 1.8-fold in the presence of the strong inhibitor of CYP3A/P-gp ketoconazole in healthy volunteers. No dose adjustment is needed when Mirabegron is combined with inhibitors of CYP3A and/or P-gp. However, in patients with mild to moderate renal impairment or mild hepatic impairment concomitantly receiving strong CYP3A inhibitors, such as itraconazole, ketoconazole, ritonavir and clarithromycin, the recommended dose is 25 mg once daily with or without food. Mirabegron is not recommended in patients with severe renal impairment or patients with moderate hepatic impairment concomitantly receiving strong CYP3A inhibitors.
Effect of enzyme inducers: Substances that are inducers of CYP3A or P-gp decrease the plasma concentrations of Mirabegron. No dose adjustment is needed for Mirabegron when administered with therapeutic doses of rifampicin or other CYP3A or P-gp inducers.
Effect of Mirabegron on CYP2D6 substrates: In healthy volunteers, the inhibitory potency of Mirabegron towards CYP2D6 is moderate and the CYP2D6 activity recovers within 15 days after discontinuation of Mirabegron. Multiple once daily dosing of Mirabegron IR resulted in a 90% increase in Cmax and a 229% increase in AUC of a single dose of metoprolol. Multiple once daily dosing of Mirabegron resulted in a 79% increase in Cmax and a 241% increase in AUC of a single dose of desipramine. Caution is advised if Mirabegron is co-administered with medicinal products with a narrow therapeutic index and significantly metabolised by CYP2D6, such as thioridazine, Type 1 C antiarrhythmics (e.g., flecainide, propafenone) and tricyclic antidepressants (e.g., imipramine, desipramine). Caution is also advised if Mirabegron is co-administered with CYP2D6 substrates that are individually dose titrated.
Effect of Mirabegron on transporters: Mirabegron is a weak inhibitor of P-gp. Mirabegron increased Cmax and AUC by 29% and 27%, respectively, of the P-gp substrate digoxin in healthy volunteers. For patients who are initiating a combination of Mirabegron and digoxin, the lowest dose for digoxin should be prescribed initially. Serum digoxin concentrations should be monitored and used for titration of the digoxin dose to obtain the desired clinical effect.
Other interactions: No clinically relevant interactions have been observed when Mirabegron was co-administered with therapeutic doses of solifenacin, tamsulosin, warfarin, metformin or a combined oral contraceptive medicinal product containing ethinylestradiol and levonorgestrel. Dose-adjustment is not recommended.
","Mirabegron is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients and severe uncontrolled hypertension defined as systolic blood pressure 180 mm Hg and/or diastolic blood pressure 110 mm Hg.
","The most common side effects reported for patients treated with Mirabegron 50 mg during the three 12-week phase 3 double blind, placebo controlled studies are tachycardia and urinary tract infections. The frequency of tachycardia was 1.2% in patients receiving Mirabegron 50 mg. Tachycardia led to discontinuation in 0.1% patients receiving Mirabegron 50 mg. The frequency of urinary tract infections was 2.9% in patients receiving Mirabegron 50 mg. Urinary tract infections led to discontinuation in none of the patients receiving Mirabegron 50 mg. Serious adverse reactions included atrial fibrillation (0.2%).
","There are limited amount of data from the use of Mirabegron in pregnant women. Studies in animals have shown reproductive toxicity. Mirabegron is not recommended during pregnancy and in women is planning to be pregnant. Mirabegron is excreted in the milk of rodents and therefore is predicted to be present in human milk. No studies have been conducted to assess the impact of Mirabegron on milk production in humans, its presence in human breast milk, or its effects on the breast-fed child. Mirabegron should not be administered during breast-feeding. There were no treatment-related effects of Mirabegron on fertility in animals. The effect of Mirabegron on human fertility has not been established.
","Renal impairment: Mirabegron has not been studied in patients with end stage renal disease (GFR <15 mL/min/1.73 m2 or patients requiring haemodialysis) and therefore, it is not recommended for use in this patient population. Data are limited in patients with severe renal impairment (GFR 15 to 29 mL/min/1.73 m2); based on a pharmacokinetic study a dose reduction to 25 mg is recommended in this population. Mirabegron is not recommended for use in patients with severe renal impairment (GFR 15 to 29 mL/min/1.73 m2) concomitantly receiving strong CYP3A inhibitors.
Hepatic impairment: Mirabegron has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and, therefore, it is not recommended for use in this patient population. Mirabegron is not recommended for use in patients with moderate hepatic impairment (Child-Pugh Class B) concomitantly receiving strong CYP3A inhibitors.
Hypertension: Mirabegron can increase blood pressure. Blood pressure should be measured at baseline and periodically during treatment with Mirabegron, especially in hypertensive patients. Data are limited in patients with stage 2 hypertension (systolic blood pressure 160 mm Hg or diastolic blood pressure 100 mm Hg).
Patients with congenital or acquired QT prolongation: Caution should be exercised when administering Mirabegron in patients with congenital or acquired QT prolongation.
Patients with bladder outlet obstruction and patients taking antimuscarinics medications for OAB: A controlled clinical safety study in patients with bladder outlet obstruction (BOO) did not demonstrate increased urinary retention in patients treated with Mirabegron; however, Mirabegron should be administered with caution to patients with clinically significant bladder outlet obstruction. Mirabegron should also be administered with caution to patients taking antimuscarinic medications for the treatment of OAB.
",,"Mirabegron has been administered to healthy volunteers at single doses up to 400 mg. At this dose, adverse events reported included palpitations and increased pulse rate exceeding 100 beats per minute (bpm). Multiple doses of Mirabegron up to 300 mg daily for 10 days showed increases in pulse rate and systolic blood pressure when administered to healthy volunteers. Treatment for overdose should be symptomatic and supportive. In the event of overdose, pulse rate, blood pressure, and ECG monitoring is recommended.
",,,"Store in a cool and dry place, protected from light.
",12
+761,Minoxidil,minoxidil-761,https://medex.com.bd/attachments/3khhyW7KIZOLWHQXyxydPuAcHAEZhw/minoxidil-prescribing-information,Other scalp preparations,Male pattern baldness,"Minoxidil is indicated in the treatment of androgenic alopecia in males and females and stabilisation of hair loss in patients with androgenic alopecia, and also of alopecia areata.
","Other scalp preparations
","Minoxidil stimulates hair growth by increasing oxygen, blood and nutrients supply to the hair follicle by widening blood vessels and inhibiting androgen hormone to affect hair follicles.
Following topical application, an average of about 1.4% of the total applied dose is absorbed from the normal intact scalp. Topical Minoxidil absorption is increased by increasing the dose applied, increasing the frequency of dosing and decreasing the barrier function of the stratum corneum. Serum Minoxidil levels and systemic effects resulting from the administration of topical Minoxidil are governed by the drug’s absorption rate through the skin. Following cessation of topical dosing, approximately 95% of the systemically absorbed drug is eliminated within 4 days. Minoxidil and its metabolites are excreted principally in the urine.
","Minoxidil topical solution is for external use only and should be applied when the hair and scalp are clean and dry. Apply 1 ml (7 sprays) of Minoxidil topical solution twice daily at 12-hour intervals to the scalp, beginning at the centre of the affected area and spreading the solution out to cover the entire affected area. The total daily application dose should not exceed 2 ml.
For the best results, Minoxidil topical solution should be allowed to remain on the scalp for about 4 hours before washing. The night-time application should be done 2-4 hours before going to bed to allow the solution to dry out. Minoxidil topical solution should not be massaged into the scalp, but applied lightly. A hair dryer should not be used to speed up the drying of the solution as it may decrease the effectiveness. Minoxidil topical solution should not be mixed with any hair oil. The drug should not be used more than two times a day, or be taken orally or applied to any other part of the body to avoid the risk of adverse effects and unwanted hair growth. More frequent use or longer application time have no effect on hair growth. In case of missing any daily applications of Minoxidil topical solution, the patient should continue with the next application.
Hands should be washed immediately if Minoxidil topical solution is applied with the fingertips. Clinical experience with Minoxidil indicates that twice-daily applications for 4 months or more may be required before there is evidence of hair growth. To arrest hair fall, Minoxidil topical solution should be used for not less than 45 days. Depending upon the severity of hair loss or type and extent of baldness, particular strength of Minoxidil topical solution may be selected.
",,"Minoxidil topical solution should not be used along with other topical agents known to alter the stratum corneum barrier such as tretinoin or dithranol, due to the enhanced absorption of Minoxidil. Although there is no clinical evidence, there exists the theoretical possibility of absorbed Minoxidil potentiating orthostatic hypotension caused by peripheral vasodilators.
","
+- Patients with cardiac abnormalities
+- Children below 18 years of age
+- Patients using occlusive dressings or other medicines on the scalp
+- Patients with red, inflamed infection, or irritated or painful scalp (including psoriasis & sunburn)
+
","Commonly encountered side effects in clinical trials with Minoxidil topical solution were minor dermatological reactions. Dermatitis or hypertrichosis may occur. These incidences may occur in 0.1–5% of patients.
","Minoxidil topical solution should not be used during pregnancy and lactation.
","Minoxidil topical solution is more likely to cause scalp irritation. If scalp irritation continues or worsen, use of Minoxidil topical solution should be stopped.
",,"Increased systemic absorption of Minoxidil may potentially occur if higher-than-recommended doses of Minoxidil are applied to larger surface areas of the body or areas other than the scalp. There are no known cases of Minoxidil overdosage resulting from topical administration of Minoxidil.
Signs and symptoms of Minoxidil overdosage would primarily be cardiovascular effects associated with sodium and water retention, and tachycardia. Fluid retention can be managed with appropriate diuretic therapy. Clinically significant tachycardia can be controlled by administration of a beta-adrenergic blocking agent.
",,,"Store at a cool and dry place, protected from light. Keep out of the reach of the children.
",11
+1601,Minocycline Hydrochloride,minocycline-hydrochloride-1601,https://medex.com.bd/attachments/TwUioqGQSWacepkXnVBQqccPtUA6Ue/minocycline-hydrochloride-prescribing-information,Tetracycline group of drugs,Urinary tract infection,"Minocycline is indicated for oral administration, for the treatment of infections caused by tetracycline sensitive organisms and some tetracycline resistant strains of staphylococci. Indications include: Acne, skin and soft tissue infections, ophthamological infections, acute and chronic bronchitis ... Read more
Minocycline is indicated for oral administration, for the treatment of infections caused by tetracycline sensitive organisms and some tetracycline resistant strains of staphylococci. Indications include: Acne, skin and soft tissue infections, ophthamological infections, acute and chronic bronchitis, bronchiectasis, lung abscess, ear, nose and throat infections, pelvic inflammatory disease, nocardiosis, urinary tract infections, gonorrhoea, non-gonococcal urethritis and prostatitis. Minocycline may also be used in prophylactic treatment of asymptomatic meningococcal carriers. Also indicated in pre- and post-operative prophylaxis of infection.
","Tetracycline group of drugs
",,"
+- Routine antibiotic use: 200 mg daily in divided doses
+- Acne: 50 mg twice daily for at least 6 weeks.
+- Gonorrhoea: Males: 200 mg initially followed by 100 mg every 12 hours for a minimum of 4 days. Post therapy cultures within 2-3 days. Females: May require a more prolonged therapy.
+- Prophylaxis of asymptomatic meningococcal carriers: 100 mg twice daily for 5 days, followed by treatment with rifampicin.
+
+If, after six months, there is no satisfactory response minocycline should be discontinued and other therapies considered. If minocycline is to be continued for longer than six months, patients should be monitored at least three monthly intervals thereafter for signs and symptoms of hepatitis or SLE.
",,"Anticoagulants: Plasma prothrombin activity is depressed by tetracyclines. Reduced doses of any concomitant anticoagulants may be necessary.
ACE inhibitors, antacids and adsorbants: Tetracyclines bind to di-/tri-valent cations. Absorption from the gastrointestinal tract is impaired by the concomitant administration of iron, calcium, aluminium, magnesium, bismuth and zinc salt (interactions with specified salts, antacids, kaolin, bismuth containing ulcer-healing drugs, quinapril which contains a magnesium carbonate excipient). Dosages should be maximally separated. Absorption of tetracyclines is not significantly impaired by food, milk and milk products.
Diuretics: Diuretics may aggravate nephrotoxicity by volume depletion.
Antibacterials: Minocycline should not be used with penicillins.
Ergotamine and ergometrine: There is an increased risk of ergotism.
Oral contraceptives: Both can induce hyperpigmentation.
Retinoids: Administration of isotretinoin should be avoided shortly before, during and shortly after minocycline therapy.
","Minocycline is contraindicated in patients with hypersensitivity to tetracyclines, systemic lupus erythematosus, pregnancy, lactation, complete renal failure and children under 12 years.
","Reported side effects are oral and anogenital candidiasis, vulvovaginitis, eosinophilia, leucopenia, neutropenia, thrombocytopenia, haemolytic anaemia, pancytopenia, agranulocytosis, anaphylaxis, anaphylactoid reaction, hypersensitivity, pulmonary infiltrates, anaphylactoid purpura, polyarthritisnodosa, abnormal thyroid function, brown-black discolouration of the thyroid, anorexia, dizziness, headache, hypaesthesia, paraesthesia, intracranial hypertension, vertigo, Bulging fontanelle, convulsions, sedation, impaired hearing, tinnitus, myocarditis, pericarditis, cough, dyspnoea, bronchospasm, exacerbation of asthma, pulmonary eosinophilia, pneumonitis, diarrhoea, nausea, stomatitis, discolouration of teeth, vomiting, dyspepsia, dysphagia, enamel hypoplasia, enterocolitis, oesophagitis, oesophageal ulceration, glossitis, pancreatitis, pseudomembranous colitis, increased liver enzymes, hepatitis, autoimmune hepatotoxicity, hepatic cholestatis, hepatic failure, hyperbilirubinemia, jaundice, autoimmune hepatitis, alopecia, erythema multiforme, erythema nodosum, fixed drug eruption, hyperpigmentation of the skin, photosensitivity, pruritis, rash, urticaria, vasculitis, angioedema, exfoliative dermatitis, hyperpigmentation of nails, Stevens-Johnson syndrome, toxic epidermal necrolysis, Drug reaction with eosinophilia and systemic symptoms (DRESS), arthralgia, lupus-like syndrome, myalgia, arthritis, bone discolouration, cases of systemic lupus erythematous (SLE), joint stiffness, joint swelling, increased serum urea, acute renal failure, interstitial nephritis, balanitis, fever, etc. In some cases involving these syndromes, death has been reported.
Hyperpigmentation of various body sites including the skin, nails, teeth, oral mucosa, bones, thyroid, eyes (including sclera and conjunctiva), breast milk, lacrimal secretions and perspiration has been reported. This blue/black/grey or muddy-brown discolouration may be localised or diffuse. The most frequently reported site is in the skin. Pigmentation is often reversible on discontinuation of the drug, although it may take several months or may persist in some cases. The generalised muddy-brown skin pigmentation may persist, particularly in areas exposed to the sun.
","Minocycline use during pregnancy and lactation is contraindicated. Animal studies have indicated that tetracyclines cross the placenta. Tetracyclines have been found in foetal tissues and can have toxic effects on the developing foetus (related to retardation of skeletal development). Studies on animals treated during early pregnancy also indicate embryotoxicity. The use of tetracyclines during the last half of pregnancy, when the teeth are developing, may cause permanent discolouration of teeth (more common with long term or repeated short term use). Enamel hypoplasia has also been reported. Tetracyclines have been detected in the milk of lactating women. Permanent tooth discolouration may occur in the developing infant and enamel hypoplasia has been reported.
","Breathing difficulties: Cases of breathing difficulties including dyspnoea, bronchospasm, exacerbation of asthma, pulmonary eosinophilia and pneumonitis have been reported with minocycline use. If patients develop breathing difficulties they should seek urgent medical advice and minocycline should be discontinued.
Paediatric population: All tetracyclines form a stable calcium complex in any bone forming tissue. An increase in the fibula growth rate has been observed in premature babies administered oral tetracyclines. Tetracyclines are known to cause a yellow to brown discoloration of the teeth and enamel hypoplasia in the developing child or foetus.
Hepatic impairment: Minocycline should be used with caution in patients with hepatic dysfunction or in conjunction with potentially hepatotoxic drugs, including alcohol.
Auto-immune disorders: Rare cases of auto-immune hepatotoxicity and isolated cases of systemic lupus erythematosus (SLE) have been reported. If patients develop signs or symptoms of SLE or hepatotoxicity, minocycline should be discontinued.
Renal impairment: Studies indicate there is no significant drug accumulation in patients with mild to moderate renal impairment when treated with the recommended dosages of minocycline. In cases of severe renal impairment a reduction of dosage and monitoring of renal function may be required.
Cross-sensitivities: Micro-organisms can develop cross resistance to tetracyclines and patients can develop cross sensitivity. Minocycline should be discontinued there are signs/symptoms of overgrowth of resistant organisms.
Intracranial hypertension: As with other tetracyclines, bulging fontanelles in infants and benign intracranial hypertension in juveniles and adults have been reported. Presenting features were headache and visual disturbances including blurring of vision, scotoma and diplopia. Permanent vision loss has been reported. Treatment should cease if evidence of raised intracranial pressure develops.
Hyperpigmentation: As with other tetracyclines, minocycline may cause hyperpigmentation at various body sites. Hyperpigmentation may present regardless of dose or duration of therapy but develops more commonly during long term treatment. Patients should be advised to report any unusual pigmentation without delay and minocycline should be discontinued.
Photosensitivity: Tetracyclines are known to cause photosensitivity reactions. Such patients should be warned to avoid direct exposure to natural or artificial sunlight and to discontinue therapy at the first sign of skin discomfort.
","Renal impairment: As adults even in cases of mild to moderate renal impairment. However, caution is advised in patients with severe renal impairment.
Paediatric population: Minocycline is not recommended in children under 12 years. Children over 12 years: 50mg every 12 hours.
","Dizziness, nausea and vomiting are the adverse effects most commonly seen in overdose. Gastric lavage plus appropriate supportive treatment. Antacids and calcium salts will reduce absorption of minocycline but there is no specific antidote. Minocycline is not removed in significant quantities by haemodialysis or peritoneal dialysis.
",,,"Store in a cool and dry place, protected from light, store below 25°C.
",11
+1857,Miltefosine,miltefosine-1857,https://medex.com.bd/attachments/gG6HZgMVi02qqPJHQJDvzvyFes21LH/miltefosine-prescribing-information,Leishmaniacides,Visceral leishmaniasis,"Miltefosine is an antileishmanial drug indicated in adults and adolescents ≥12 years of age weighing ≥30 kg (66 lbs) for treatment of:
+
+- Visceral leishmaniasis due to Leishmania donovani.
+- Cutaneous leishmaniasis due to Leishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis.
+- Mucosal leishmaniasis due to Leishmania braziliensis.
+
","Leishmaniacides
","Miltefosine has demonstrated activity against Leishmania parasites and neoplastic cells primarily due to its effects on apoptosis and disturbance of lipid-dependent cell signalling pathways. Several potential antileishmanial mechanisms of action have been proposed, however no mechanism has been identified definitely. Within the mitochondria, miltefosine inhibits cytochrome-c oxidase leading to mitochondrial dysfunction and apoptosis-like cell death. Antineoplastic mechanisms of action are related to antileishmanial targets and include inhibition of phosphatidylcholine biosynthesis and inhibition of Akt (also known as protein kinase B), which is a crucial protein within the PI3K/Akt/mTOR intracellular signalling pathway involved in regulating the cell cycle. Animal studies also suggest it may be effective against Trypanosome cruzi (the organism responsible for Chagas' disease), metronidazole-resistant strains of Trichonomas vaginalis, and it may have broad-spectrum anti-fungal activity.
","Administer with food to ameliorate gastrointestinal adverse reactions.
+
+- 30 to 44 kg: one 50 mg capsule twice daily for 28 consecutive days.
+- 45 kg or greater: one 50 mg capsule three times daily for 28 consecutive days.
+
",,"
+- Miltefosine did not inhibit human cytochrome P450 enzymes in vitro.
+- Miltefosine did not induce cytochrome 3A activity in rats.
+
",,"Adverse reactions occurring in ≥2% of patients include nausea, vomiting, diarrhea, headache, decreased appetite, dizziness, abdominal pain, pruritus, somnolence, elevated transaminases, and elevated creatinine.
","Pregnancy: Miltefosine should not be used during pregnancy. Obtain a urine or serum pregnancy test in females of reproductive potential prior to prescribing.
Nursing Mothers: Discontinue drug or nursing depending on the importance of drug to the mother. Avoid breastfeeding for 5 months after Miltefosine therapy.
Females and Males of Reproductive Potential: Advise females to use effective contraception during therapy and for 5 months after therapy. Advise patients of reproductive toxicities in animals, and that the potential for impaired fertility in humans has not been adequately evaluated
","
+- Embryo-Fetal Toxicity. Do not use in pregnant women. Obtain a urine or serum pregnancy test prior to initiation of therapy. Advise use of effective contraception in females of reproductive potential.
+- Reproductive effects. Miltefosine caused testicular atrophy and impaired fertility in male rats and impaired fertility in female rats. Advise patients of reproductive toxicities in animal studies and that the potential effects on human fertility have not been adequately evaluated.
+- Renal Effects. Monitor serum creatinine during therapy and for 4 weeks after end of therapy.
+- Hepatic Effects. Monitor transaminases and bilirubin during therapy.
+- Gastrointestinal Effects. Encourage fluid intake.
+- Thrombocytopenia. Monitor platelet count during therapy for visceral leishmaniasis.
+- Absorption of Oral Contraceptives. Advise use of alternative method of contraception if vomiting and/or diarrhea occur.
+- Stevens-Johnson syndrome. Discontinue miltefosine.
+
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+760,Milnacipran Hydrochloride,milnacipran-hydrochloride-760,https://medex.com.bd/attachments/iqbARgQebdEAZZ7ykJj9X5LHOcs9hq/milnacipran-hydrochloride-prescribing-information,Serotonin-norepinephrine reuptake inhibitor (SNRI),Fibromyalgia,"Milnacipran is indicated for the management of fibromyalgia. Milnacipran is not approved for use in pediatric patients
","Serotonin-norepinephrine reuptake inhibitor (SNRI)
","Milnacipran is a potent inhibitor of neuronal norepinephrine and serotonin reuptake. It inhibits norepinephrine uptake with approx 3-fold higher potency in vitro than serotonin with directly affecting the uptake of dopamine or other neurotransmitters.
","The recommended dose of Milnacipran is 100 mg/day (50 mg twice daily). Based on efficacy and tolerability dosing may be titrated according to the following schedule:
Day 1: 12.5 mg once
Days 2-3: 25 mg/day (12.5 mg twice daily)
Days 4-7: 50 mg/day (25 mg twice daily)
After Day 7: 100 mg/day (50 mg twice daily)
Based on individual patient response, the dose may be increased to 200 mg/day (100 mg twice daily). Doses above 200 mg/day have not been studied.
","Should be taken with food. Preferably taken during meals.
","Increased risk of bleeding with aspirin, NSAIDs, warfarin and other drugs that affect coagulation. Increased CNS effects with centrally-acting drugs (e.g. clomipramine). Increased risk of serotonin syndrome and NMS-like reactions with serotonergic drugs (e.g. tramadol), SSRIs, other selective serotonin-norepinephrine reuptake inhibitors, 5-HT1 receptor agonists (e.g. sumatriptan), antipsychotic agents and other dopamine antagonists. May inhibit antihypertensive effect of clonidine. May potentiate adverse haemodynamic effects with digoxin. Paroxysmal HTN and cardiac arrhythmia may occur when taken concurrently with epinephrine or norepinephrine.
","Uncontrolled narrow-angle glaucoma. Concomitant use with MAOI or within 2 wk after withdrawal of MAOI.
","Increased heart rate, HTN, increased liver enzymes, severe liver injury, hyponatraemia, abnormal bleeding, dysuria, mydriasis, nausea, vomiting, constipation, headache, insomnia, dizziness, hot flushes, hyperhidrosis, palpitations, dry mouth, migraine.
","Pregnancy: Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during Milnacipran therapy. Patients should be encouraged to enroll in the Milnacipran Pregnancy Registry if they become pregnant, preferably before any prenatal testing is done. This registry is collecting information about the safety of milnacipran during pregnancy.
Nursing: Advise patients to notify their physician if they are breast feeding
","Patient with major depressive disorder or other psychiatric disorders, history of dysuria, controlled narrow-angle glaucoma, pre-existing HTN, tachyarrhythmias or other CV disease, history of seizure disorder or condition predisposing to seizures (e.g. brain damage, alcoholism). Avoid abrupt withdrawal. Severe hepatic and moderate to severe renal impairment including ESRD. Pregnancy and lactation.
","Renal Impairment: Severe (CrCl 5-29 mL/min): 25 mg bid, may increase to 50 mg bid according to response.
End stage renal disease (ESRD): Not recommended.
Pediatric use: Safety and effectiveness of Milnacipran in a fibromyalgia pediatric population below the age of 18 have not been established. The use of Milnacipran is not recommended in pediatric patients.
","Symptoms: Increased BP, cardio-resp arrest, changes in the level of consciousness (ranging from somnolence to coma), confusional state, dizziness, and increased hepatic enzymes.
Management: Symptomatic treatment with gastric lavage and activated charcoal. Maintain adequate airway, oxygenation and ventilation and monitor cardiac rhythm and vital signs. May give cyproheptadine with adequate temp control to treat serotonin syndrome.
",,,"Store at 25° C.
",13
+759,Miglitol,miglitol-759,https://medex.com.bd/attachments/6GEvTZzTfakYxciJ4UisqbSmE07mgL/miglitol-prescribing-information,Alpha-Glucosidase inhibitor,Type 2 DM,"Miglitol is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
","Alpha-Glucosidase inhibitor
","Miglitol reversibly inhibits membrane-bound intestinal α-glucosidase enzymes which hydrolyse oligosaccharides and disaccharides to glucose and other monosaccharides in the small intestinal brush border. It delays carbohydrate breakdown, glucose absorption and reduces postprandial hyperglycaemia.
","There is no fixed dosage regimen for the management of diabetes mellitus with Miglitol Tablets or any other pharmacologic agent. Dosage of Miglitol must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended dosage of 100 mg 3 times daily. Miglitol should be taken three times daily at the start of each main meal. Miglitol should be started at 25 mg, and the dosage gradually increased both to reduce gastrointestinaladverse effects and to permit identification of the minimum dose required for adequate glycemic control of the patient. During treatment initiation and dose titration one-hour postprandial plasma glucose may be used to determine the therapeutic response to Miglitol and identify the minimum effective dose for the patient.
Thereafter, glycosylated hemoglobin should be measured at intervals of approximately 3 months. The therapeutic goal should be to decrease both postprandial plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of Miglitol, either as monotherapy or in combination with a sulfonylurea.
Initial Dosage: The recommended starting dosage of Miglitol is 25 mg, given orally three times daily at the start of each main meal. However, some patients may benefit by starting at 25 mg once daily to minimize gastrointestinal adverse effects, and gradually increasing the frequency of administration to 3 times daily.
Maintenance Dosage: The usual maintenance dose of Miglitol is 50 mg taken 3 times daily, although some patients may benefit from increasing the dose to 100 mg 3 times daily. To allow adaptation to potential gastrointestinal adverse effects, it is recommended that Miglitol therapy be initiated at a dosage of 25 mg 3 times daily, then gradually titrated upward to allow adaptation. After 4 to 8 weeks of the 25 mg 3 times daily regimen, the dosage should be increased to 50 mg 3 times daily for approximately three months, following which a glycosylated hemoglobin level should be measured to assess therapeutic response. If at that time, the glycosylated hemoglobin level is not satisfactory, the dosage may be further increased to 100 mg 3 times daily, the maximum recommended dosage.
Maximum Dosage: The maximum recommended dosage of Miglitol is 100 mg 3 times daily. In one clinical trial, 200 mg 3 times daily gave additional improved glycemic control but increased the incidence of the gastrointestinal symptoms described above.
Patients Receiving Sulfonylureas: Sulfonylurea agents may cause hypoglycemia. There was no increased incidence of hypoglycemia in patients who took Miglitol in combination with sulfonylurea agents compared to the incidence of hypoglycemia in patients receiving sulfonylureas alone in any clinical trial. However, Miglitol given in combination with a sulfonylurea will cause a further lowering of blood glucose and may increase the risk of hypoglycemia due to the additive effects of the two agents. If hypoglycemia occurs, appropriate adjustments in the dosage of these agents should be made
","Should be taken with food. Take with 1st bite of each main meal.
","Concomitant use with insulin increases the risk of hypoglycaemia. Intestinal adsorbents (e.g. charcoal) and carbohydrate-splitting digestive enzyme supplements (e.g. amylase, pancreatin) may reduce glycaemic effects. May significantly reduce the bioavailability of ranitidine and propranolol.
","Patient with diabetic ketoacidosis, inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or predisposition to this condition, chronic intestinal diseases associated with marked disorders of digestion or absorption and co-existing conditions that may deteriorate as a result of increased intestinal gas formation.
","Abdominal pain or discomfort, diarrhoea, flatulence, skin rash.
","Category B: Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
","Patient exposed to stress (e.g. fever, trauma, infection, surgery). Renal impairment. Pregnancy and lactation.
",,,,,"Store at 25° C.
",11
+758,Mifepristone + Misoprostol,mifepristone-misoprostol-758,https://medex.com.bd/attachments/LQU9JSXir0EZNQf38GYeAWcpaPV8fN/mifepristone-misoprostol-prescribing-information,Prostaglandin analogues,Termination of pregnancy,"This kit is indicated for early Menstrual Regulation (MR)/termination of pregnancy up to 9 weeks (63 days) of gestation.
","Drugs acting on the Uterus, Prostaglandin analogues
","Mifepristone: Mifepristone is a synthetic steroid with anti-progestational activity results from competitive interaction with progesterone at progesterone-receptor sites. Based on studies with various oral doses in several animal species, the compound inhibits the activity of endogenous or exogenous progesterone and the Menstrual Regulation (MR) results. During pregnancy, the compound sensitizes the myometrium to the contraction-inducing activity of prostaglandins.
Misoprostol: Misoprostol is a synthetic analogue of prostaglandin E1. It causes myometrial contraction by interacting with specific receptors on myometrial cells. This interaction results in a change in calcium concentration, thereby initiating muscle contraction. By interacting with prostaglandin receptors, Misoprostol causes the cervix to soften and the uterus to contract, resulting in the expulsion of the uterine contents.
","This can only be prescribed by qualified medical professionals who are able to assess the gestational age of an embryo and to diagnose ectopic pregnancies. The qualified medical professionals must also be able to provide surgical Intervention/MVA (Manual Vaccum Aspiration) in cases of incomplete abortion or severe bleeding or have made plans to provide such care through others and be able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.
Day 1 (First visit): Mifepristone administration: One tablet of Mifepristone (200 mg) is taken in a single oral dose under the supervision of a qualified medical professional in a clinic, medical office or hospital.
Day 2 (Second visit): Misoprostol administration: 24-48 hours after ingesting the Mifepristone tablet, the patient takes four 200 microgram tablets (800 micrograms) of Misoprostol buccally or sublingually. Misoprostol tablets can be administered by the patient herself (place two tablets on each side of cheeck & gum or under the tongue). She should wait for 30 minutes. During the period immediately following the administration of Misoprostol, the patient may need medication for cramps or gastrointestinal symptoms. The patient should be given instructions on what to do if significant discomfort, excessive bleeding or other adverse reactions occur and should be given a phone number to call if she has questions following the administration of Misoprostol.
Day 10 to 14 (Third visit): Post-treatment examination: Patients must return to the clinic, medical office or hospital within 10 to 14 days after the administration of mifepristone. This visit is very important to confirm by clinical examination or ultrasonographic scan that a complete termination of pregnancy has occurred.
Patients who have an ongoing pregnancy at this visit have a risk of fetal malformation resulting from the treatment. Surgical termination/MVA is recommended to manage Menstrual Regulation (MR)/termination of pregnancy failures.
",,"Mifepristone: Although specific drug or food interactions with Mifepristone have not been studied, on the basis of this drug's metabolism by CYP 3A4, it is possible that Ketoconazole, Itraconazole, Erythromycin and grapefruit juice may inhibit its metabolism (increasing serum levels of mifepristone).
Misoprostol: Misoprostol has not been shown to interfere with the beneficial effects of aspirin on signs and symptoms of rheumatoid arthritis. Misoprostol does not exert clinically significant effects on the absorption,blood levels and antiplatelet effects of therapeutic doses of aspirin.
","Administration of Mifepristone is contraindicated in patients with any one of the following conditions: History of allergy or known hypersensitivity to Mifepristone, Misoprostol or other prostaglandin, confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy), IUD in place, chronic adrenal failure, haemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyria, If a patient does not have adequate access to medical facilities equipped to provide emergency treatment of incomplete process, blood transfusions and emergency resuscitation during the period from the first visit until discharged by the administering physician.
","Mifepristone: The treatment procedure is designed to induce vaginal bleeding and uterine cramping necessary for Menstrual Regulation (MR). Commonly reported side effects were nausea, vomiting and diarrhoea. Pelvic pain, fainting, headache, dizziness, and asthenia occurred rarely.
Misoprostol: Gastro-intestinal side-effects like diarrhoea, abdominal pain, nausea, flatulence, dyspepsia, headache, vomiting and constipation, shivering, hyperthermia, dizziness, pain due to uterine contractions, severe vaginal bleeding, shock, pelvic pain, uterine rupture (requiring surgical repair, hysterectomy and/or salpingo-oophorectomy).
","Pregnancy-
Mifepristone: is indicated for Menstrual Regulation (MR) (through 63 days pregnancy) and has no other approved indication for use during pregnancy. Patients who have an ongoing pregnancy at the last visit have a risk of foetal malformation resulting from the treatment. Surgical termination is recommended to manage Menstrual Regulation (MR) treatment failures.
Lactation-
+
+- Mifepristone: It is not known whether Mifepristone is excreted through human milk. Many hormones with a similar chemical structure, however, are excreted in breast milk. Since the effects of Mifepristone on infants are unknown, breast-feeding women should consult with their doctor to decide if they should discard their breast milk for a few days following administration of the medications.
+- Misoprostol: Although it is not known whether Misoprostol or Misoprostol is excreted through human milk, Misoprostol should not be administered to nursing mothers because the potential excretion of misoprostol acid could cause diarrhoea in nursing infants.
+
","The patient should not give combination of Mifepristone & Misoprostol to anyone else. The combination of Mifepristone & Misoprostol has been prescribed for the patient's specific condition, it may not be the correct treatment for another person, and may be dangerous to the other person if she is or were to become pregnant. Any Intra Uterine Device [IUD] should be removed before treatment with Mifepristone begins. Menstrual Regulation (MR) by surgery is recommended in cases when combination of Mifepristone & Misoprostol fails to cause Menstrual Regulation (MR). Patients who have an ongoing pregnancy at last visit have a risk of foetal malformation resulting from the treatment. Surgical termination/MVA is recommended to manage Menstrual Regulation (MR)/ termination of pregnancy failures.
","Use in Patients with Hepatic Impairment: Patients with hepatic disease should receive a decreased dose of Misoprostol.
Use in Patients with Renal Impairment: No routine dosage adjustment is recommended of Misoprostol in older patients or patients with renal impairment but the dosage may need to be reduced if the usual dose is not tolerated.
","Mifepristone: No serious adverse reactions were reported in tolerance studies in healthy nonpregnant female and healthy male subjects where Mifepristone was administered in single doses greater than threefold of 600mg for Menstrual Regulation (MR). If a patient ingests a massive overdose, she should be observed closely for signs of adrenal failure.
Misoprostol: Clinical signs that may indicate an overdose are a sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhoea, fever, palpitations, hypotension or bradycardia. Symptoms should be treated with supportive therapy. However, because Misoprostol is metabolized like a fatty acid, it is unlikely that dialysis would be the appropriate treatment for overdosage.
",,,"Store in a cool and dry place, protected from light.
",12
+757,Mifepristone,mifepristone-757,https://medex.com.bd/attachments/w1vh7MHly34juF1jK5uzDwVEDQQvtU/mifepristone-prescribing-information,Drugs acting on the Uterus,Uterine fibroids,"Mifepristone is indicated:
+
+- As a medical alternative to surgical termination of intra-uterine pregnancy
+- Softening and dilatation of the cervix uteri prior to surgical pregnancy termination
+- Preparation for the action of prostaglandin analogues in the termination of pregnancy for medical reasons
+- Labour induction for the expulsion of a dead fetus (fetal death in utero).
+
","Drugs acting on the Uterus
","Mifepristone is a synthetic steroid which blocks the effects of progesterone by competitively binding to the intracellular progesterone receptor. It sensitises the myometrium to the contraction-inducing action of prostaglandin. At higher doses, it blocks the effect of cortisol at the glucocorticoid receptor while increasing circulating cortisol concentrations.
","As a medical alternative to surgical termination of intra-uterine pregnancy in early pregnancy: 600 mg Mifepristone in a single oral dose followed 36-48 hrs later, by the administration of a prostaglandin analogue Misoprostol 400 mcg orally (up to 49 days) or Gemeprost 1 mg vaginally (up to 63 days).
Softening and dilatation of the cervix uteri prior to surgical pregnancy termination: 200 mg Mifepristone, followed 36-48 hrs later (but not beyond) by a surgical termination of pregnancy.
Preparation for the action of prostaglandin analogues in the termination of pregnancy for medical reasons (to reduce the doses of prostaglandin): 600 mg of Mifepristone taken in a single oral dose, 36-48 hrs prior to scheduled prostaglandin administration which will be repeated as often as indicated.
Labour induction for expulsion of a dead fetus (fetal death in utero): 600 mg of Mifepristone in a single oral daily dose for 2 consecutive days. Mifepristone alone leads to expulsion in about 60%. Labour should be induced by the usual methods if it has not started within 72 hrs following the first administration of Mifepristone.
","There are no precautions for timing in relation to food.
","ketoconazole, itraconazole, erythromycin and grapefruit juice may inhibit its metabolism (increasing serum levels of mifepristone). Furthermore, rifampicin, dexamethasone, St John's Wort and certain anticonvulsants (phenytoin, phenobarbital, carbamazepine) may induce mifepristone metabolism (lowering serum levels of Mifepristone). Based on invitro inhibition information, co-administration of mifepristone may lead to an increase in serum levels of drugs that are CYP3A4 substrates.
Limited evidence suggests that co-administration of NSAIDs on the day of prostaglandin administration does not adversely influence the effects of Mifepristone or the prostaglandin on cervical ripening or uterine contractility and does not reduce the clinical efficacy of medical termination of pregnancy.
","Mifepristone must not be administered if there is doubt as to the existence or age of the pregnancy or if an extra-uterine pregnancy is suspected. An ultrasound scan and/or measurement of Beta-hCG must be performed before administration. For first trimester abortions, Mifepristone is contraindicated if the pregnancy is beyond 49 days of amenorrhoea when used with Misoprostol, or beyond 63 days of amenorrhoea when used with Gemeprost. Mifepristone should never be prescribed in patients with chronic adrenal failure, known allergy to Mifepristone or to any component of the product, severe asthma uncontrolled by corticosteroid therapy, porphyrias and renal failure, liver failure or malnutrition, or during breast feeding. Mifepristone is a lipophilic compound and may theoretically be excreted in the mother\'s breast milk, however no data is available.
","It is very common for women to experience uterine contractions or cramping (10-45%) in the hours following prostaglandin intake. Bleeding increases with gestational age. Heavy bleeding occurs in about 5% of cases and from 0-1.4% may require haemostatic curettage. Uterine rupture, hypotension, skin rashes, urticaria, hot flashes and dizziness have been uncommonly reported.
","Pregnancy: Mifepristone is indicated for use in the termination of pregnancy (through 49 days’ pregnancy) and has no other approved indication for use during pregnancy.
Lactation: It is not known whether Mifepristone is excreted in human milk. Many hormones with a similar chemical structure, however, are excreted in breast milk. Since the effects of Mifepristone on infants are unknown, breast-feeding women should consult with their health care provider to decide if they should discard their breast milk for a few days following administration of the medications.
","Mifepristone is available only in single dose packaging. Administration must be under the supervision of a qualified physician. There are no data on the safety and efficacy of Mifepristone in women with chronic medical conditions such as cardiovascular, hypertensive, hepatic, respiratory or renal disease; insulin-dependent diabetes mellitus; severe anemia or heavy smoking. Women who are more than 35 years of age and who also smoke 10 or more cigarettes per day should be treated with caution because such patients were generally excluded from clinical trials of Mifepristone. Although there is no clinical evidence, the effectiveness of Mifepristone may be lower if Misoprostol is administered more than two days after Mifepristone administration.
","Use in children: Safety and effectiveness in pediatric patients have not been established.
","Single doses of Mifepristone up to 2 gm caused no unwanted reaction. In the event of massive ingestion, signs of adrenal failure might occur. Acute intoxication may require admission to hospital and if relevant treatment with dexamethasone.
",,,"Store at 25° C.
",13
+756,Midazolam,midazolam-756,https://medex.com.bd/attachments/XkSnAvzpjkQpLffD1pbUdcadpnaIKI/midazolam-prescribing-information,Benzodiazepine hypnotics,Status epilepticus,"Midazolam is indicated in-
+
+- Short-term treatment of insomnia.
+- Sedation in premedication before surgical or diagnostic procedures.
+
","Benzodiazepine hypnotics, Benzodiazepine sedatives
","The actions of benzodiazepines such as midazolam are mediated through the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), which is one of the major inhibitory neurotransmitters in the central nervous system. Benzodiazepines increase the activity of GABA, thereby producing a sedating effect, relaxing skeletal muscles, and inducing sleep, anesthesia, and amnesia. Benzodiazepines bind to the benzodiazepine site on GABA-A receptors, which potentiates the effects of GABA by increasing the frequency of chloride channel opening. These receptors have been identified in different body tissues including the heart and skeletal muscle, although mainly appear to be present in the central nervous system.
","Oral dosage:
+
+- For adults: 7.5-15 mg daily.
+- In elderly and debilitated patients: The recommended dose is 7.5 mg.
+- In premedication: 15 mg of Midazolam should be given 30-60 minutes before the procedure.
+
+Intravenous administration:
+
+- Endoscopic or Cardiovascular Procedures: In healthy adults, the initial dose is approximately 2.5 mg. In cases of severe illness and in elderly patients, the initial dose must be reduced to 1 to 1.5 mg.
+- Induction of Anesthesia: The dose is 10-15 mg.
+
+Intramuscular administration:
+
+- Adult: 0.07-0.1 mg/kg body weight. The usual dose is about 5 mg.
+- Children: 0.15-0.20 mg/kg
+- Elderly and debilitated patients: 0.025-0.05 mg/kg
+
+Rectal administration in children:
+
+- For preoperative sedation: Rectal administration of the ampoule solution (0.35-0.45 mg/kg) 20-30 min. before induction of general anesthesia.
+
",,"Midazolam can enhance the central sedative effect of neuroleptics, tranquillizers, antidepressants, sleep-inducing drugs, analgesics, anaesthetics, antipsychotics, anxiolytics, antiepileptic drugs and sedative antihistamines.
","Midazolam must not be given to patients with severe respiratory insufficiency, severe hepatic insufficiency, myasthenia gravis, sleep apnea syndrome and with known hypersensitivity to benzodiazepines or to any component of the product
","At the start of therapy, drowsiness during daytime, confusion, fatigue, headache and muscle weakness may occur which usually disappear with repeated administration. Following parenteral (IV or IM) administration of Midazolam, fluctuations in vital signs have been noted including respiratory depression, apnea, variations in blood pressure and pulse rate.
","Midazolam should be avoided during pregnancy unless there is no safer alternative. Since Midazolam passes into breast milk, it should not be administered to breast-feeding mothers.
","Midazolam IV should be administered very slowly.
",,"Extreme overdosage may lead to coma, areflexia, cardiorespiratory depression and apnea. The effects of overdosage can be controlled with benzodiazepine antagonist flumazenil.
",,,"Protect from light and moisture, store in cool and dry place. Keep out of the reach of children.
",11
+369,Micronised Diosmin + Hesperidin,micronised-diosmin-hesperidin-369,,Phlebotonic & Vascular protecting preparation,Piles,"It is indicated in the treatment of-
+
+- Acute hemorrhoidal attacks.
+- Chronic hemorrhoidal disease.
+- Organic and functional chronic venous insufficiency of the lower limbs with the following symptoms: heavy legs, pain, nocturnal cramps.
+
","Phlebotonic & Vascular protecting preparation
","Diosmin and Hesperidin is a phlebotonic drug and a vascular protecting agent. It reinforces venous tone by prolonging the activity of parietal noradrenaline. Thus Diosmin and Hesperidin decreases venous capacitance, venous distensibility, and venous emptying time.
Diosmin and Hesperidin protects the microcirculation by fighting the microcirculation damaging process; It combats venous inflammation by decreasing leukocyte activation, and as a consequence, by inhibiting the release of inflammatory mediators, principally free radicals and prostaglandin. Thus Diosmin and Hesperidin normalizes capillary permeability and strengthens capillary resistance.
Diosmin and Hesperidin acts on the lymphatic system, It improves lymphatic drainage by increasing lymph flow and lymph oncotic pressure.
","Diosmin 450 mg & Hesperidin 50 mg-
+
+- Acute hemorrhoidal attacks: 3 tablets twice daily for the first 4 days, then 2 tablets twice daily for three days and if required 1 tablet twice daily as a maintenance dosage.
+- Chronic hemorrhoids: 1 tablet twice daily.
+- Chronic venous insufficiency: 1 tablet twice daily initially for seven days. Duration may be increased depending on severity.
+
+Diosmin 900 mg & Hesperidin 100 mg-
+
+- Acute Hemorrhoid: 1 tablet thrice daily for first 4 days, followed by 1 tablet twice daily for 3 days & then 1 tablet once daily as maintenance dose.
+- Relapse of Internal Hemorrhoid & Chronic Hemorrhoid: 1 tablet once daily for 3 months.
+- Chronic venous insufficiency: 1 tablet once daily for 2-6 months.
+- Leg Wounds: 1 tablet once daily for 2 months.
+
","Tablet should be taken at meal times.
","No evidence of drug incompatibility (drug interaction) has been reported in clinical trials.
","Chronic venous insufficiency and its complications should be diagnosed and management monitored by a physician. It is contraindicated for anyone having a hypersensitivity to any ingredient in the product.
","Some cases of routine gastric disorders and neurovegetative disorders (feeling of discomfort) have been reported. In this cases discontinuation of treatment is not required.
","Experimental studies have not shown any teratogenic effect in animals. In human beings, no harmful effect has so far been reported. In the absence of data concerning excretion into breast milk, breast feeding is not recommended during treatment.
","If the hemorrhoidal symptoms do not disappear within 15 days, patient should ask doctor for advice. Diosmin (up to 900 mg/day) has been administered to a small number of breast cancer patients who were experiencing lymphedema following surgical and nodal irradiation treatment with resultant reduction of arm edema but no effect on the cancer. Animal studies and more than 20 years of clinical use in Europe have not found any evidence of carcinogenicity or mutagenicity when the components of Diosmin & Hesperidin are used as recommended. As a precaution, Diosmin & Hesperidin is not recommended for patients with a history of cancer since no specific studies have been performed in this population.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+578,Miconazole Nitrate + Hydrocortisone,miconazole-nitrate-hydrocortisone-578,https://medex.com.bd/attachments/fDZABljuhfstwBMEk4SH4AaSfaeyoe/miconazole-nitrate-hydrocortisone-prescribing-information,Hydrocortisone & Combined preparations,Sweat rash,"For the topical treatment of inflamed dermatoses where infection by susceptible organisms and inflammation coexist e.g. intertrigo and infected eczema. For moist or dry eczema or dermatitis including atopic eczema, primary irritant or contact allergic eczema or seborrheic eczema including that ... Read more
For the topical treatment of inflamed dermatoses where infection by susceptible organisms and inflammation coexist e.g. intertrigo and infected eczema. For moist or dry eczema or dermatitis including atopic eczema, primary irritant or contact allergic eczema or seborrheic eczema including that associated with acne. Also for interiginous eczema including inflammatory interigo, perianal and genital dermatitis. Organisms which are susceptible to miconazole are dermatophytes and pathogenic yeasts (e.g. Candida spp.): also many Gram-positive bacteria including many strains of Streptococcus and Staphylococcus.
","Hydrocortisone & Combined preparations
","Miconazole is a substituted imidazole, is one of the family of azoles useful in treating the superficial candidiasis and of the skin infections dermatophytosis and pityriasis versicolor, acanthameaba, seborrhoic dermatitis. Also active against Aspergillus spp., Cryptococcus neoformans, Pseudalescheria boydii and some gram-positive bacteria including Staphylococci and Streptococci.
Hydrocortisone is a naturally occurring glucocorticoid that's now prepared synthetically. Its important function is in the skin injury such as inflammation. Also it has antipruritic, antimycotic and vasoconstrictive activity.
Miconazole is imidazole antifungal agents that interfere with ergosterol synthesis and therefore alters the permeability of the cell membrane of sensitive fungi. Thus causes the killing of fungi, when applied to the skin, Hydrocortisone is absorbed into the skin cells. It prevents the release of certain chemicals, which is responsible for inflammation. Thus hydrocortisone reduces inflammation.
","Apply to the affected area as a thin film two or four times daily for 1 to 2 weeks. Rub it well with your finger until this cream fully vanished on the skin. Treatment should be continued at least one week after the disappearance of all signs and symptoms. The same dosage applies to both adults and children.
",,"Amphotericin antagonizes the activity of Miconazole.
","It is contraindicated in individuals who are hypersensitive to it or any of its components. Should not be used in pregnant mother and lactating mother without physician's advice.
","Rarely local sensitivity may occur. Long term use may decrease in the production of natural hormones by the adrenal gland.
","Administration of corticosteroids to pregnant animal at high doses can cause abnormalities of fetal development. Topical steroids should not be extensively used in pregnancy.
","To be dispensed only on the prescription of a registered physician. Keep out of reach of children. Take care or consult with a physician in case of use in children and elderly people for long-term use.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+1326,Miconazole Nitrate (Topical),miconazole-nitrate-topical-1326,,Topical Antifungal preparations,Tinea corporis (ringworm),"Skin and nail infections due to dermatophytes, yeasts and other fungi such as: Tinea capitis, corporis, manuum, pedis, barbae, cruris, unguium or onychomycosis. Pityriasis versicolor, candidiasis of skin and nails, stomatitis angularis, otitis externa. Since Miconazole Topical Cream has an antibacterial ... Read more
Skin and nail infections due to dermatophytes, yeasts and other fungi such as: Tinea capitis, corporis, manuum, pedis, barbae, cruris, unguium or onychomycosis. Pityriasis versicolor, candidiasis of skin and nails, stomatitis angularis, otitis externa. Since Miconazole Topical Cream has an antibacterial effect on Gram-positive bacteria, it may be used in mycoses secondarily infected with such bacteria.
","Topical Antifungal preparations
","Miconazole topical cream is a broad-spectrum antimycotic which offers a high antifungal activity against dermatophytes, yeasts and other phyco-Asco and Adelomycetes, with a potent antibacterial activity against Gram-positive bacilli and cocci. Miconazole topical cream proved to be markedly effective in secondary infected mycoses, which under other treatments were resistant or reappeared. Miconazole topical cream does not stain skin or clothes.
","The dosage is same for all the ages.
For skin infections: Apply some cream to the lesions twice daily and rub it well with finger until it has fully penetrated the skin. All lesions usually disappear after 2 to 5 weeks. Prolong treatment for some 10 days to prevent relapse.
For nail infections: Clip infected nail as shortly as possible. Apply some cream once daily to the infected nail and rub with your finger, cover nail with a non-perforated occlusive plastic bandage.
Also after loosening of the infected nail (from 2-3 weeks onwards) uniterrupted treatment should be continued until the growth of a new nail has set in and definite cure can be observed (usually after seven months or more).
",,,"No contraindication is known.
","Topical application of Miconazole Nitrate has almost no side effect.
","Only small amounts of Miconazole nitrate are absorbed following local administration. However as with other imidazoles, Miconazole nitrate should be used with caution during pregnancy.
","Miconazole Nitrate is intended for topical use. If accidental ingestion of large quantities of the product occurs, an appropriate method of gastric emptying may be used if considered desirable.
",,,,,"Store away from direct heat. Keep out of reach of children.
",9
+754,Miconazole Nitrate (Oral Gel),miconazole-nitrate-oral-gel-754,https://medex.com.bd/attachments/c6iDn0P4a1jK0eAehWwrnZ0dGFD9eZ/miconazole-nitrate-oral-gel-prescribing-information,Aural Anti-fungal preparations,Fungal infections of the mouth Throat and gut,"Miconazole Nitrate oral gel is indicated-
+
+- For the treatment of oral and gastrointestinal candidiasis.
+- For eradication of fungal colonization in the mouth and gastrointestinal tract.
+- For the treatment of super infections due to gram-positive bacteria.
+
","Aural Anti-fungal preparations
","Pharmacodynamics: Miconazole possesses an antifungal activity against the common dermatophytes and yeasts as well as an antibacterial activity against certain gram-positive bacilli and cocci. Its activity is based on the inhibition of a demethylation step in the ergosterol biosynthesis. Ergosterol, the end-product of the biosynthetic pathway and the main sterol in yeast and fungi. The disruption in production of ergosterol disrupts the fungal cell membrane, causing holes to appear in it. These holes allow the essential constituents of the fungal cells to leak out and ultimately the fungal cells die.
Pharmacokinetics: The oral bioavailability of Miconazole is low (25-30%) because there is little absorption of Miconazole from the intestinal tract. Miconazole is systemically absorbed after administration as the oral gel. Absorbed Miconazole is bound to plasma proteins (88.2%), primarily to serum albumin and red blood cells (10.6%). The absorbed portion of Miconazole oral gel is largely metabolized; less than 1% of the administered dose is excreted unchanged in the urine. The terminal plasma half-life is 20-25 hours in most patients. The elimination half-life of Miconazole is similar in any renal impaired patient.
","Oropharyngeal candidosis-
+
+- Infants 4-24 months: 1.25 ml (1⁄4 measuring spoon) of gel, applied 4 times day after meals.
+- Adult and children 2 years of age and older: 2.5 ml (1⁄2 measuring spoon) of gel, applied 4 times a day after meals.
+
+
Gastrointestinal tract candidosis-
+
+- Infants (4 months of age or above): Children and adults who have difficulty swallowing tablets: 20 mg per kg body weight per day, in four divided doses. The daily dose should not exceed 250 mg (10 ml gel) four times daily.
+
+
Missed Dose: Apply the missed dose as soon as you remember. In case of next dosing time, omit the missed
dose and continue your usual course.
","In case of localized lesions of the mouth, a small amount of gel may be applied 2-4 times a day directly to the affected area with a clean finger. For best results, Miconazole oral gel should be kept in contact with the affected area as long as possible. The treatment should be continued for at least a week after symptoms have disappeared. For oral candidosis, dental prosthesis should be removed at night and brushed with the gel.
","
+- Concomitant treatment with Terfenadine, Astemizole and Cisapride should be avoided because in vitro studies suggest that Miconazole may inhibit their metabolism, so these products miqht precipitated.
+- Miconazole may delay Phenytoin and Cyclosporine metabolism and this might precipitate Phenytoin and Cyclosporine toxicity, respectively.
+
","Miconazole is contraindicated in patients with known hypersensitivity to the active ingredient.
","Occasionally nausea and vomiting, diarrhea with long term use and rarely allergic reactions.
","There is no information regarding the safety of Miconazole oral gel during pregnancy. So Miconazole oral gel should be avoided in pregnant women if possible or the potential hazards should be balanced against the possible benefits. As many drugs are excreted in human milk, caution should be exercised when Miconazole is administered to a nursing woman.
","If the concomitant use of Miconazole and anticoagulant is considered, the anti-coagulant effect should be monitored and titrated. Miconazole and phenytoin plasma level should also be monitored when used concomitantly. In infants and young children, caution must be taken to ensure that the gel does not obstruct the throat.
",,"Accidental overdosage may cause vomiting and diarrhea. Treatment is symptomatic and supportive. A specific antidote is not available.
",,,"keep in a dry place away from light and heat. Keep out of the reach of children.
",12
+753,Metronidazole + Neomycin Sulphate + Polymyxin B + Nystatin,metronidazole-neomycin-sulphate-polymyxin-b-nystatin-753,,Drugs used in Vaginal and Vulval condition,Vaginal leucorrhoea,"This combination is indicated in-
+
+- Vaginal trichomoniasis
+- Vaginal leucorrhoeas
+- Mixed vaginal infections (Fungal or Bacterial).
+
","Drugs used in Vaginal and Vulval condition
","Metronidazole, a nitroimidazole, is active against various anerobic bacteria and protozoa. Nystatin is a polyene antibiotic with antifungal activity. Neomycin is an aminoglycoside. It is bactericidal and active against some gram-positive and gram-negative organisms. Polymyxin is active against gram-negative organisms including Pseudomonas aeruginosa.
","One suppository in the vagina at bedtime for 12 days or as directed by the physician.
",,,"Contraindicated to the patients who are hypersensitive to Metronidazole, Neomycin Sulphate, Polymyxin B Sulphate and Nystatin.
","Skin rash, urticaria may occur rarely.
","Caution should be practiced in pregnancy and lactation.
","Caution should be taken in case of renal impairment.
",,,,,"Store in a cool and dry place, away from light & children.
",9
+752,Metronidazole + Miconazole Nitrate,metronidazole-miconazole-nitrate-752,,Drugs used in Vaginal and Vulval condition,Vaginal candidiasis or thrush,"Vaginal treatment of female urogenital trichomonas infection, prevention & local therapy of candidiasis.
","Drugs used in Vaginal and Vulval condition
","Metronidazole is converted to reduction products that interact with DNA to cause destruction of helical DNA structure and strand leading to a protein synthesis inhibition and cell death in susceptible organisms. It is active against most anaerobic protozoa, some gm+ve, gm-ve and facultative anaerobes.
Miconazole inhibits ergosterol synthesis thus damaging fungal cell wall membrane and increases its permeability, allowing leakage of nutrients.
","In trichomoniasis, concurrently with oral metronidazole treatment and 1 vaginal tablet should be inserted high up into the vagina once a day (preferably before going to bed at night) for 10 days. Long-term recovery may be expected only is response to the simultaneous oral treatment of both partners.
In candidiasis or other fungal infections, 1 vaginal tablet has to be inserted high up into the vagina for 10 days. The vaginal tablet should be slightly moistened before application.
",,"Metronidazole: Disulfiram-like reaction with alcohol. Increased oral anticoagulant effect, blood levels of phenytoin, lithium toxicity, plasma cone of astemizole & terfenadine; blood cone of carbamazepine. Decreased blood levels with phenobarb. Risk of CNS-related effects (eg psychotic reactions) with disulfiram. Increased blood levels & neurologic effects with cimetidine. May increase blood levels & toxicity of fluorouracil; toxicity of cyclosporine. Increased cardiotoxicity with amiodarone. Interference with blood levels of liver enzymes, glucose (hexokinase method), theophylline & procainamide. Decreased levels with phenytoin.
Miconazole: Increased risk of bleeding with acenocoumarol, anisindione, dicumarol, phenindione, phenprocoumon, warfarin; plasma cone & exposure to oxybutinin.
May increase risk of phenytoin, phosphenytoin, cyclosporine, trimetrexate toxicity & cardiotoxicity with pimozide. May inhibit metabolism of astemizole, cisapride & terfenadine. Reduced carbamazepine metabolism. Increased or prolonged effects of opioid (fentanyl). May cause hypoglycemia with glimepiride. Reduced clearance & increased plasma cone of oxycodone. May increase bioavailability of tolterodine (in patients with deficient CYP2D6 activity).
","Hypersensitivity; hepatic impairment (oral gel). Porphyria.
","Nausea, vomiting, febrile reactions, rash, drowsiness, diarrhoea, anorexia and flushing, hepatitis. Local irritation and sensitisation, contact dermatitis.
","Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","For external use only; discontinue if sensitization or irritation occurs. Pregnancy and lactation
",,,,,,9
+751,Metronidazole,metronidazole-751,https://medex.com.bd/attachments/8JEgac3ReMFh73rOp4tKgZXRwtalZq/metronidazole-vaginal-gel-prescribing-information,Amoebicides,Vaginal trichomoniasis,"Metronidazole is indicated in the treatment of following diseases:
+
+- The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
+- The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
... Read more
Metronidazole is indicated in the treatment of following diseases:
+
+- The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
+- The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
+- In the treatment of urogenital trichomoniasis.
+- Bacterial vaginosis (also known as non-specific vaginitis).
+- All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
+- Giardiasis.
+- Acute ulcerative gingivitis.
+- Anaerobically infected leg ulcers and pressure sores.
+- Acute dental infections due to anaerobic organisms.
+- Antibiotic associated pseudomembranus colitis.
+
","Amoebicides, Anti-diarrhoeal Antiprotozoal
","Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.
","Tablet and Suspension:
+Trichomoniasis (Adults & Children over 10 yrs)-
+
+- 200 mg tid or 400 mg bid for 7 days
+- 800 mg in the morning and 1-2 gm at night for 2 days
+- 2 gm as a single dose for 1 days
+
+Trichomoniasis (Children)-
+
+- Children 7-10 yrs: 100 mg tid
+- Children 3-7 yrs: 100 mg bid
+- Children 1-3 yrs: 50 mg tid
+
+Intestinal amoebiasis (Adults & Children over 10 yrs)-
+
+Intestinal amoebiasis (Children)-
+
+- Children 7-10 yrs: 400 mg tid
+- Children 3-7 yrs: 200 mg qid
+- Children 1-3 yrs: 200 mg tid
+
+Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-
+
+- 400-800 mg tid for 5-10 days
+
+Extra-intestinal & Asymptomatic amoebiasis (Children)-
+
+- Children 7-10 yrs: 200-400 mg tid
+- Children 3-7 yrs: 100-200 mg qid
+- Children 1-3 yrs: 100-200 mg tid
+
+Giardiasis (Adults & Children over 10 yrs)-
+
+- 2 gm once daily for 3 days
+
+Giardiasis (Children)-
+
+- Children 7-10 yrs: 1 gm once daily
+- Children 3-7 yrs: 600-800 mg once daily
+- Children 1-3 yrs: 500 mg once daily
+
+Acute ulcerative gingivitis (Adults & Children over 10 yrs)-
+
+Acute ulcerative gingivitis (Children)-
+
+- Children 7-10 yrs: 100 mg tid
+- Children 3-7 yrs: 100 mg bid
+- Children 1-3 yrs: 50 mg tid
+
+Acute dental infections (Adults & Children over 10 yrs)-
+
+- 200 mg tid for 3-7 days
+
+Bacterial Vaginosis (Adults & Children over 10 yrs)-
+
+- 400 mg bid for 7 days
+- 2 gm as a single dose for 1 days
+
+Leg ulcers and pressure sores (Adults & Children over 10 yrs)-
+
+Anaerobic infections (Adults & Children over 10 yrs)-
+
+- 800 mg initially and then 400 mg tid for 7 days
+
+Anaerobic infections (Children)-
+
+- Children 1-10 yrs: 7.5 mg/kg tid
+
+Surgical prophylaxis (Adults & Children over 10 yrs)-
+
+- 400 mg tid started 24 hours before surgery for 1 days
+
+Surgical prophylaxis (Children)-
+
+- Children 1-10 yrs: 7.5 mg/kg tid
+
+
+
Vaginal Gel:
+The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.
+
Suppository:
+Anaerobic Infections-
+
+- Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
+- Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.
+
+Surgical Prophylaxis-
+
+- Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
+- Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.
+
+
IV Infusion:
+Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.
+
+- Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
+- Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.
+
",,"
+- Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
+- Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
+- Lithium: Plasma levels of lithium may be increased by metronidazole.
+- Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
+- Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
+- 5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
+- Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.
+
","Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.
","Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.
","US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.
","
+- If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
+- Metronidazole should be administered with caution to patients with hepatic encephalopathy.
+- Patients should be warned that metronidazole may darken urine.
+
","Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.
Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
","Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.
",,,"Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.
",12
+750,Metoprolol Tartrate,metoprolol-tartrate-750,https://medex.com.bd/attachments/7J6BcpQSi5YEo8P7qSzPHwAogYizL8/metoprolol-tartrate-extened-release-tablet-prescribing-information,,,"ln the management of hypertension and angina pectoris. Cardiac arrhythmias, especially supraventricular tachyarrhythmias. Adjunct to the treatment of hyperthyroidism. Early intervention with Metoprolol in acute myocardial infarction reduces infarct size and the incidence of ventricular fibrillation ... Read more
ln the management of hypertension and angina pectoris. Cardiac arrhythmias, especially supraventricular tachyarrhythmias. Adjunct to the treatment of hyperthyroidism. Early intervention with Metoprolol in acute myocardial infarction reduces infarct size and the incidence of ventricular fibrillation. Pain relief may also decrease the need for opiate analgesics. Metoprolol has been shown to reduce mortality when administered to patients with acute myocardial infarction.
",,"Metoprolol is a selective beta1-blocker. Metoprolol reduces or inhibits the agonistic effect on the heart of catecholamines (which are released during physical and mental stress). This means that the usual increase in heart rate, cardiac output, cardiac contractility and blood pressure, produced by the acute increase in catecholamines, is reduced by Metoprolol. Metoprolol interferes less with Insulin release and carbohydrate metabolism than do non-selective beta-blockers. Metoprolol interferes much less with the cardiovascular response to hypoglycaemia than do non-selective beta-blockers.
","Film-coated tablet
-
+
+- Hypertension: Total daily dosage Metoprolol 100-400 mg to be given as a single or twice-daily dose. The starting dose is 100 mg (two Metoprolol-50 tablets) per day. This may be increased by 100 mg per day at weekly intervals. lf full control is not achieved using a single daily dose, a b.i.d. regimen should be initiated. Combination therapy with a diuretic or other antihypertensive agents may also be considered.
+- Angina: Usually Metoprolol 50 mg (one Metoprolol-50 tablet) to 100 mg (two Metoprolol-50 tablets) twice or three times daily.
+- Cardiac arrhythmias: Metoprolol 50 mg (one Metoprolol-50 tablet) b.i.d or t.i.d should usually control the condition. It is necessary the dose can be increased up to 300 mg per day in divided doses. Following the treatment of an acute arrhythmia with Metoprolol injection, continuation therapy with Metoprolol tablets should be initiated 4-6 hours later. The initial oral dose should not exceed 50 mg t.i.d.
+- Hyperthyroidism: Metoprolol 50 mg (one Metoprolol-50 tablet) four times a day. The dose should be reduced as the euthyroid state is achieved.
+- Myocardial infarction: Orally, therapy should commence 15 minutes after the last injection with 50 mg every 6 hours for 48 hours. Patients who fail to tolerate the full intravenous dose should be given half the suggested oral dose. Maintenance- The usual maintenance dose is 200 mg daily given in divided doses. Elderly’ There are no special dosage requirements in otherwise healthy elderly patients. Significant hepatic dysfunction: A reduction in dosage may be necessary.
+
+Extended-release tablet-
+
+- Hypertension: The usual initial dosage is 25 to 100 mg daily in a single dose, whether used alone or added to a diuretic.
+- Angina Pectoris: The dosage of extended-release Metoprolol Succinate should be individualized. The usual initial dosage is 100 mg daily, in a single dose.
+- Heart Failure: The recommended starting dose of sustained-release Metoprolol Succinate is 25 mg once daily for two weeks in patients with NYHA class II heart failure and 12.5 mg once daily in patients with more severe heart failure. The dosage may be increased at weekly (or longer) intervals until optimum blood pressure reduction is achieved. If treatment is to be discontinued, the dosage should be reduced gradually over a period of 1-2 weeks.
+
+IV Injection-
+
+- Arrhythmias: By intravenous injection, up to 5 mg at a rate of 1-2 mg/minute, repeated after 5 minutes if necessary, total dose 10-15 mg.
+- In surgery: By slow intravenous injection 2-4 mg at induction or to control arrhythmias developing during anaesthesia; 2 mg doses may be repeated to a maximum of 10 mg.
+- Myocardial Infarction: Early intervention within 12 hours of infarction, by intravenous injection 5 mg every 2 minutes to a maximum of 15 mg, followed after 15 minutes by 50 mg by mouth every 6 hours for 48 hours; maintenance 200 mg daily in divided doses.
+
",,"Catecholamine‐depleting drugs (e.g. Reserpine, Monoamine Oxidase (MAO) inhibitors) may have an additive effect when given with beta‐blocking agents. Drugs that inhibit CYP2D6 such as quinidine, fluoxetine, paroxetine and propafenone are likely to increase Metoprolol concentration. These increases in plasma concentration would decrease the cardioselectivity of Metoprolol. Concomitant use of digitalis glycosides and beta‐blockers can increase the risk of bradycardia. Beta‐blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine.
","AV block, Uncontrolled heart failure, severe bradycardia, sick-sinus syndrome, cardiogenic shock and severe peripheral arterial disease. Known hypersensitivity to Metoprolol or other B-blockers. Metoprolol is also contra-indicated when myocardial infarction is complicated by significant bradycardia, first-degree heart block, systolic hypotension (<100mmHg) and/or severe heart failure.
","Tiredness, dizziness, depression, diarrhea, itching or rash, shortness of breath, slow heart rate, mental confusion, headache, somnolence, nightmares, insomnia, dyspnea, Nausea, dry mouth, gastric pain, constipation, flatulence, digestive tract disorders, heartburn, pruritus, musculoskeletal pain, blurred vision, decreased libido, and tinnitus have also been reported, intensification of AV block.
","Pregnancy Category C. There are no adequate and well‐controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Metoprolol is excreted in breast milk in very small quantities. Caution should be exercised when Metoprolol is administered to a nursing woman.
","Bronchospastic Diseases: Because of its relative beta 1 ‐selectivity, however, Metoprolol may be used with caution in patients with bronchospastic disease who do not respond to, or cannot tolerate other antihypertensive treatment.
Major Surgery: The necessity or desirability of withdrawing beta‐blocking therapy prior to major surgery is controversial; the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.
Diabetes and Hypoglycemia: Beta‐blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected. Peripheral Vascular Disease: Beta‐blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Calcium Channel Blockers: Because of significant inotropic and chronotropic effects in patients, caution should be exercised in patients treated with these agents concomitantly.
","Hepatic impaired patient: Metoprolol should be used with caution in patients with impaired hepatic function.
Pediatric Use: No clinically relevant differences in the adverse event profile were observed for pediatric patients aged 6 to 16 years as compared with adult patients. Safety and effectiveness of Metoprolol have not been established in patients <6 years of age.
Geriatric Use: There were no notable differences in efficacy or the rate of adverse events between older and younger patients.
","Poisoning due to an overdose of metoprolol may lead to severe hypotension, sinus bradycardia, atrioventricular block, heart failure, cardiogenic shock, cardiac arrest, bronchospasm, impairment of consciousness, coma, nausea, vomiting, cyanosis, hypoglycaemia and, occasionally, hyperkalaemia. The first manifestations usually appear 20 minutes to 2 hours after drug ingestion. Treatment: Treatment should include close monitoring of cardiovascular, respiratory and renal function, and blood glucose and electrolytes. Further absorption may be prevented by induction of vomiting, gastric lavage or administration of activated-charcoal if ingestion is recent. Cardiovascular complications should be treated symptomatically, which may require the use of sympathomimetic agents (e.g. noradrenaline, metaramionl), atropine or inotropic agents (e.g. dopamine, dobutamine). Temporary pacing may be required for AV block. Glucagon can reverse the effects of excessive B-blockade, given in a dose of 1-10 mg intravenously. Intravenous B2-stimulants e.g. terbutaline may be required to relieve bronchospasm. Metoprolol cannot be effectively removed by haemodialysis.
",,,"Store in a cool and dry place, protected from light.
",11
+1134,Multivitamin [Injection],multivitamin-injection-1134,,Specific combined vitamin preparations,Vitamin B deficiencies,"This IV preparation is intended as a supplement for intravenous nutrition in order to meet the daily requirements of the water-soluble vitamins in infants, children and adults.
","Specific combined vitamin preparations
","This IV preparation is a sterile, lyophilized powder of water soluble vitamins for infusion. It contains balanced amount of all the important water soluble vitamins which act as coenzymes of vital enzymes associated with crucial physiological processes, energy metabolism, cell growth and replenishment especially in brain and nerve cells. Vitamin C acts as an antioxidant and helps in collagen formation. Intravenous administration of this combination gives prompt action.
","Adults and children weighing 10 kg or more: 1 vial (10 ml) daily.
Children weighing less than 10 kg: should be given 1 ml of the dissolved mixture per kg body weight/day.
","The contents of one vial are dissolved by the aseptic addition of 10 ml of one of the following:
+
+- Water for injection
+- Fat emulsion 10%
+- Glucose solution for infusion (5% to 60%)
+- Normal saline (0.9% Sodium Chloride)
+
+This IV preparation may be added to parenteral nutrition admixtures containing carbohydrates, lipids, amino acids, electrolytes, and trace elements provided that compatibility and stability have been confirmed.
","Vitamin B6 can reduce the effect of levodopa. Folic acid may lower the serum concentration of phenytoin.
","Known hypersensitivity to any of the components, e.g. Thiamine.
","Allergic reactions may occur in patients hypersensitive to any component of the preparation, e.g. Thiamine.
","Animal reproduction studies or clinical investigations during pregnancy have not been carried out with this preparation. However, there are published reports on safe administration of water soluble vitamins in this patient group.
","This IV preparation is diluted with water-based solutions, the admixture should be protected from light. This is not necessary if this IV preparation is diluted with intralipid because of the protective effect of the fat emulsion.
",,"No adverse effects of an overdose of water soluble multivitamin have been reported, with exception of cases of extremely high parenteral doses. The possibility of hypervitaminosis A and D should be considered if the content of This IV preparation is dissolved in another multivitamin injection.
",,,"Before reconstitution: Store below 25° C. Protect from light. After reconstitution: The reconstituted IV preparation should be added to the infusion solution aseptically immediately before the start of the infusion & used within 24 hours.
",12
+839,Multivitamin [Adult preparation],multivitamin-adult-preparation-839,,Specific combined vitamin preparations,Vitamin deficiency,"This preparation is indicated for the treatment and prevention of vitamin deficiencies.
","Specific combined vitamin preparations
","Vitamin A plays an essential role in the function of retina and is essential for growth and differentiation of epithelial tissue.
Vitamin B: Plays a role in the synthesis and maintenance of coenzyme A. Necessary for lipid metabolism, carbohydrate metabolism, tissue respiration, glycogenolysis, inhibition of very low-density lipoprotein (VLDL) synthesis. May increaase chylomicron triglyceride removal from plasma.
Vitamin E is an antioxidant which preserves essential cellular constituents.
Vitamin C: Necessary for collagen formation and tissue repair; plays a role in oxidation/reduction reactions as well as other metabolic pathways including synthesis of catecholamines, carnitine, and steroids; also plays a role in conversion of folic acid to folinic acid.
Vitamin D3 is a fat-soluble sterol. It is necessary for the regulation and regulation of calcium and phosphate homoeostasis and bone mineralisation. Vitamin D is also essential for healthy bones as it aids in Calcium absorption from the Gl tract. In addition to this it stimulates bone formation. Clinical studies also show that Calcium and Vitamin D has synergistic effects on bone growth as well as in Osteoporosis and fracture prevention.
","One capsule daily for adults and children over 5 years of age or as directed by the physician.
",,,"This preparation is contraindicated in patients hypersensitive to any component of the drug.
","No side-effect has been reported with such low dose of the vitamin.
","Pregnancy Category is not Classified. FDA has not yet classified the drug into a specified pregnancy category.
","Should not use in over dosage. Patients with mild to moderate renal failure. Diabetes, patients prone to recurrent renal calculi.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+2056,Mucopolysaccharide Polysulphate + Salicylic Acid,mucopolysaccharide-polysulphate-salicylic-acid-2056,https://medex.com.bd/attachments/9ZnFPJEBMXgpj1h7pjtFQAlj9RRGoF/mucopolysaccharide-polysulphate-salicylic-acid-prescribing-information,,,"This gel is indicated for mild to moderate anti-inflammatory, analgesic, symptomatic relief of muscular pain, stiffness, sprains, strains, pain due to rheumatic & non-serious arthritic conditions.
",,"Mucopolysaccharide Polysulphate (MPS) & Salicylic Acid combination is a topical preparation. It is used for mild to moderate anti-inflammatory, analgesic, symptomatic relief of muscular pain, stiffness, sprains, strains, pain due to rheumatic & non-serious arthritic conditions. Mucopolysaccharide Polysulphate (MPS) is a non-steroidal drug recognized as having anti-inflammatory activity through a weak inhibitory effect of PGE2 synthesis and an indirect effect on LTB4 production based on in vitro studies. It also shows anti-coagulant activity as a heparinoid, thrombolytic activity through potentiation of urokinase activity and anti-exudatory activity through inhibition of hyaluronidase. Salicylic acid, a non-steroidal anti-inflammatory drug, is employed in the formulation for its keratolytic activity also has anti-inflammatory and analgesic properties. The mucopolysaccharide polysulfate (MPS) and salicylic acid work together, salicylic acid gently softening the skin to allow the MPS to be absorbed where the inflamed and painful tissues are formulated in a choice of gel which can be easily massaged onto the skin to help bringing relief from pain caused by inflammation beneath. Also be used to treat pain due to rheumatic and non-serious arthritic conditions. The effects of Mucopolysaccharide Polysulphate (MPS) and Salicylic Acid are topical/localised only.
","Adults, the elderly and children over 12 years of age: Two to six inches (5-15 cm) to be massaged to the affected area up to four times a day.
Use in Childhood and Adolescence: Should not be used on children below 12 years old.
",,"Drugs or herbal products that may decrease the effectiveness of HCs include efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, rifabutin, rufinamide, aprepitant. Interactions between HCs and other drugs may lead to breakthrough bleeding and/or contraceptive failure. There is a potential for an increase in serum potassium concentration in females taking SLYND with other drugs that may increase serum potassium concentration. For example, ACE inhibitors, angiotensin-ll receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonists, and NSAIDs.
","Hypersensitivity to any of the ingredients, aspirin or other non-steroidal anti-inflammatory drugs (including when taken by mouth) especially where associated with a history of asthma. Not to be used on large areas of skin, broken, sensitive or infected skin, eczema or on mucous membranes. Not to be used on children under 12 years of age. Do not use during the first trimester, during late pregnancy or on the breast area during lactation.
","Like all medicines, this gel preparation can cause side effects, although not everybody gets them. Rarely, this medicine can cause the following in sensitive individuals: redness, burning sensation and rash. If any of these occur, stop using the gel and consult with a doctor.
","If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Gel should not be used during the first three or last three months of pregnancy or on the breast area during breastfeeding/lactation.
","For external use only. Keep away from the eyes. The stated dose should not be exceeded. If the condition persists or worsens, consult a doctor or pharmacist. Side effects of salicylates are theoretically possible. Cunsult with a doctor before use if pregnant, breast-feeding, asthmatic, have pre-existing renal damage or on any prescribed medicines (inc. coumarin anticoagulants). Salicylic acid may increase skin permeability for other topically applied medicines. Some people may experience discomfort, particularly those with sensitive skin or if used in hot weather or after a bath. Wash hands immediately after use. Discontinue use if excessive irritation or other unwanted effects occur.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+1413,Moxonidine,moxonidine-1413,https://medex.com.bd/attachments/T8250UH32YFxibtS2FtJLE2rBbNbvh/moxonidine-prescribing-information,Anti-hypertensive,Lower the blood pressure,"Moxonidine belongs to a group of drugs called anti-hypertensives that lower blood pressure. Moxonidine is used to treat high blood pressure.
","Anti-hypertensive
","Stimulation of central alpha 2-adrenergic receptors is associated with sympathoadrenal suppression and subsequent reduction of blood pressure. As this class was further explored it was discovered that sympathoadrenal activity can also be suppressed by a second pathway with a newly discovered drug target specific to imidazolines. Specifically, moxonidine binds the imidazoline receptor subtype 1 (I1) and to a lesser extent αlpha-2-adrenoreceptors in the RSV causing a reduction of sympathetic activity, reducing systemic vascular resistance and thus arterial blood pressure
Moreover, since alpha-2-adrenergic receptors are considered the primary molecular target that facilitates the most common side effects of sedation and dry mouth that are elicited by most centrally acting antihypertensives, moxonidine differs from these other centrally acting antihypertensives by demonstrating only low affinity for central alpha-2-adrenoceptors compared to the aforementioned I1-imidazoline receptors
","Adults (including the elderly): Your treatment will normally start with one 200 microgram tablet, taken in the morning. After three weeks, your doctor may increase this dose to 400 micrograms daily, given in a single dose in the morning, or in divided doses in the morning and evening. After another three weeks, your doctor may need to increase this dose to 600 micrograms daily, given in divided doses (morning and evening). You should not take more than 400 micrograms as a single dose, or more than 600 micrograms in any one day.
If you forget to take a dose, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.
If you forget to take a dose, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.
",,"Talk to your doctor if you are taking any of the following:
+
+- beta-blockers, such as propranolol or atenolol, used to treat heart problems
+- other medicines used to reduce blood pressure such as furosemide a diuretic, or captopril an angiotensin-converting enzyme inhibitor
+- antidepressants such as amitriptyline
+- sleeping tablets such as zopiclone, tranquilizers such as nitrazepam, lorazepam or phenobarbital
+- Moxonidine is removed from body by kidneys through the process called ""tubular excretion"". Other medicines removed from the kidneys in the same way could affect how moxonidine works.
+
+Do not drink alcohol whilst taking Moxonidine.
","Do NOT take Moxonidine if you:
+
+- Are allergic (hypersensitive) to moxonidine or any of the other ingredients of this medicine
+- Have a slow heart rate or suffer from an abnormal heart rhythm or a change in the rate of the heart beat (called “sick sinus syndrome” or “2nd or 3rd degree AV-block”
+- Have, or have had, heart failure or other heart problems
+
","The following side effects have been reported at the approximate frequencies shown:
+
+- Very common: dry mouth, drowsiness
+- Common: headache, dizziness (vertigo), flushing (vasodilation), weakness or loss of strength, confusion, sleep disturbances, nausea (feeling sick), being sick (vomiting), stomach upsets (dyspepsia), diarrhoea, rash or itching (pruritus), back pain
+
","Moxonidine is not recommended if you are pregnant, planning on becoming pregnant or are breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding.
","Tell your doctor before you start to take this medicine if you:
+
+- have a heart problem called ""1st-degree AV-block""
+- have a severe coronary heart disease, or have angina (chest pain at rest)
+- have poor circulation
+- have kidney disease
+- have been told you have cerebrovascular insufficiency (poor blood supply to the brain which means you are at a greater risk of stroke)
+- are below 16 years of age
+- have a rare hereditary problem of galactose intolerance, Lapp lactase deficiency or glucosegalactose malabsorption as you should not take this medicine
+
+Patients who are intolerant to lactose should note that Moxonidine tablets contain a small amount of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
","Patients with kidney problems: If you have moderate problems with your kidneys, you should not take more than one 200 microgram tablet as a single dose or more than 400 micrograms in total, a day.
Children under 16 years of age: Moxonidine is not recommended for use in children.
","If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause headache, sleepiness, dry mouth, loss of balance, dizziness, low blood pressure, slowing of the pulse, vomiting, feeling tired, weakness and pain in your stomach. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
",,,"Do not store above 30° C. Keep blister in the outer carton in order to protect from light
",12
+1542,Moxifloxacin Hydrochloride + Xanthan Gum,moxifloxacin-hydrochloride-xanthan-gum-1542,,Ophthalmic antibacterial drugs,Conjunctivitis,"This ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms-
Aerobic Gram-positive microorganisms: Corynebacterium species, Micrococcus luteus, Staphylococcus aureus, Staphylococcus epidermidis ... Read more
This ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms-
Aerobic Gram-positive microorganisms: Corynebacterium species, Micrococcus luteus, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri, Streptococcus pneumonia, Streptococcus viridans group.
Aerobic Gram-negative microorganisms: Acinetobacter iwoffii, Haemophilus influenza, Haemophilus parainfluenzae.
","Ophthalmic antibacterial drugs
","The antimicrobial action of Moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.
","One drop in the affected eye(s) 2 times daily for 7 days.
",,"Drug-drug interaction studies have not been conducted with Moxifloxacin Hydrochloride.
",,"In 1-6% patients the most frequently reported ocular adverse events are eye irritation, pyrexia, conjunctivitis, decreased visual acuity, dry eye, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage and tearing.
","Moxifloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus as there are no adequate and well-documented studies in pregnant women. Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when Moxifloxacin is administered to a breast feeding mother.
","Prolonged use may result in overgrowth of non-susceptible organisms, including fungi with other anti-infective.
","Pediatric Use: The safety and effectiveness of Moxifloxacin in infants below four months of age was not proven. However, several clinical studies show that the drug may be used safely in children even younger than one month of age.
Geriatric Use: No overall differences in safety and effectiveness have been observed between elderly and younger patients.
","There is practically no risk of adverse effects due to accidental ingestion, since a bottle of 5 ml eye drops solution contains only 25 mg Moxifloxacin that is much lower than recommended daily oral dose.
",,,"Store in a cool and dry place away from light. Keep out of reach of children. Do not touch the dropper tip to surfaces since this may contaminate the solution. After one month of the first opening do not use the medicine of dropper.
",11
+1447,Moxifloxacin Hydrochloride + Dexamethasone,moxifloxacin-hydrochloride-dexamethasone-1447,https://medex.com.bd/attachments/KlWZqtpr6Q2kJTido81cYEqkd3EN16/moxifloxacin-hydrochloride-dexamethasone-prescribing-information,Ophthalmic Steroid preparations,Steroid-responsive inflammatory ocular conditions,"Moxifloxacin & Dexamethasone eye drop is indicated in the treatment of eye infections caused by susceptible microorganisms and in the prevention of inflammation and bacterial infection that may occur after eye surgery.
","Ophthalmic Steroid preparations
","This Eye Drops is a combination of a fourth generation fluoroquinolone Moxifloxacin and a potent corticosteroid Dexmethasone. Moxifloxacin controls infection by inhibitting the DNA gyrase & Topoisomerase IV. Dexamethasone effectively controls the inflammation by inhibiting the release inflammatory mediators.
","In the prevention of infection and post-surgical ocular inflammation: Instill 1 drop, 4 times a day, in the eye to be operated, from 1 day before surgery until 15 days after surgery.
In patients undergoing cataract surgery: The day of surgery instill the medication immediately after eye surgery.
In patients undergoing LASIK refractive surgery: On the day of surgery instill the medication at least 15 minutes after ocular surgery.
In eye infections caused by susceptible microorganisms: Instill 1 drop, 4 times a day, for up to 7 days.
",,,"Hypersensitivity to quinolones. Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella & other viral diseases of cornea & conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Glaucoma & diseases causing thinning of cornea or sclera.
","Moxifloxacin: Conjunctivitis decreased visual acuity, dry eye, keratitis, Ocular discomfort, hyperemia, pain, Subconjunctival hemorrhage and tearing.
Dexamethasone: Visual acuity & field defects, cataract formation, secondary ocular infection following suppression of host response & perforation of the globe.
","There are no adequate and well-controlled studies in pregnant women. Moxifloxacin & Dexamethasone combination eye drops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution is advised when Moxifloxacin & Dexamethasone combination eye drops is given to nursing women.
","For ophthalmic use only. The solution should not be injected under the conjunctiva, nor introduced directly into the anterior chamber of the eye. Prolonged use of steroids may result in ocular hypertension
","Use in the elderly: No change in dosage is required when the product is administered in elderly patients.
Use in Children: The efficacy and safety of Moxifloxacin & Dexamethasone combination eye drops in pediatric patients have not been established.
","No information is available on overdosage with this product in humans.
",,,"Store in a cool place, below 30°C, protected from light. Once the container is opened the contents must be used within 28 days and may be stored at room temperature up to 30°C. Discard after the 28 days. Keep out of reach of children.
",11
+776,Moxifloxacin Hydrochloride (Tablet),moxifloxacin-hydrochloride-tablet-776,https://medex.com.bd/attachments/WmgzUdUB2ya26A17YJc3S1QUoPGYbt/moxifloxacin-hydrochloride-tablet-prescribing-information,4-Quinolone preparations,Acute bacterial sinusitis,"Moxifloxacin is indicated for the treatment of acute bacterial sinusitis, acute exacerbation of chronic bronchitis, community acquired pneumonia, uncomplicated & complicated skin and skin structure infections, complicated intra-abdominal infections and pelvic inflammatory disease.
","4-Quinolone preparations
","Moxifloxacin is a 4th generation synthetic broad spectrum, fluoroquinolone class of antibacterial drug. It has activity against a wide range of gram-positive, gram-negative, anaerobic and atypical bacteria including Mycoplasma pneumoniae. It acts by inhibiting topoisomerase II (DNA gyrase) and topoisomerase IV which are necessary for bacterial DNA replication, transcription & repair.
","Acute bacterial sinusitis: 400 mg once daily 7-10 days.
Acute bacterial exacerbation of chronic bronchitis: 400 mg once daily 5-10 days.
Community-acquired pneumonia: 400 mg once daily 7-14 days.
Uncomplicated skin and skin structure infections: 400 mg once daily 7 days.
Complicated skin and skin structure infections: 400 mg once daily 7-21 days.
Complicated intra-abdominal infections: 400 mg once daily 5-14 days.
Pelvic inflammatory disease: 400 mg once daily 14 days.
",,"Moxifloxacin absorption is decreased when administered with antacids, sucralfate, multivitamins, and multivalent cations (e.g. iron or zinc). Moxifloxacin may enhance the risk of convulsions with NSAIDs and bleeding with warfarin. So concomitant use of Moxifloxacin with them should be avoided.
","It is contraindicated in patients with a history of hypersensitivity to Moxifloxacin or other quinolones.
","Common side effects of Moxifloxacin include nausea, vomiting, diarrhea, headache and dizziness.
","US FDA pregnancy category C. Moxifloxacin is not recommended during pregnancy & lactation.
","Moxifloxacin may cause an increased risk of tendinitis and tendon rupture. It should be discontinued if pain or inflammation in a tendon occurs. It should not be used in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients with receiving Class IA or Class III antiarrhythmic agents
","Renal or hepatic impaired patients: No dose adjustment is necessary for patients with renal or hepatic impairment.
Pediatric patients: Safety and effectiveness of Moxifloxacin in pediatric patients and adolescent less than 18 years of age have not been established.
",,,,"Keep in a dry place, away from light and heat. Keep out of the reach of children.
",11
+1329,Moxifloxacin Hydrochloride (Ophthalmic),moxifloxacin-hydrochloride-ophthalmic-1329,https://medex.com.bd/attachments/AMyWuQoWzMaW86KV4zkpKpnyv5m5Bf/moxifloxacin-hydrochloride-ophthalmic-prescribing-information,Ophthalmic antibacterial drugs,Ocular infections,"The ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
+
+- Aerobic Gram-positive microorganisms: Corynebacterium species, Micrococcus luteus, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri, Streptococcus pneumoniae, Streptococcus viridans group.
... Read more
The ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
+
+- Aerobic Gram-positive microorganisms: Corynebacterium species, Micrococcus luteus, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri, Streptococcus pneumoniae, Streptococcus viridans group.
+- Aerobic Gram-negative microorganisms: Acinetobacterlwoffii, Haemophilusinfluenzae, Haemophilus parainfluenzae.
+- Other microorganisms: Chlamydia trachomatis.
+
","Ophthalmic antibacterial drugs
","The antimicrobial action of Moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.
","Eye Drops: One drop in the affected eye 3 times per day for 7 days.
Eye Ointment: It should be applied thinly and evenly to the affected eye three times a day for the first two days and for the next five days apply two times a day or as advised by the registered physician.
",,"Drug-drug interaction studies have not been conducted with Moxifloxacin Hydrochloride ophthalmic solution. In vitro studies indicate that Moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2 indicating that Moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these cytochrome P450 isozymes.
","Moxifloxacin Hydrochloride ophthalmic solution is contraindicated in patients with a history of hypersensitivity to Moxifloxacin, to other quinolones, or to any of the components in this medication.
","The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1-6% of patients. Nonocular adverse events reported at a rate of 1-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis.
","Since there are no adequate and well-controlled studies in pregnant women, Moxifloxacin Hydrochloride ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when Moxifloxacin hydrochloride ophthalmic solution is administered to a nursing mother.
","As with other anti-infectives, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.
",,,,,"Store bellow 25°C. Do not freeze. Store in cool and dry place, protected from light. Keep out of the reach of children. Do not touch dropper tip to any surface as this may contaminate this preparation. Do not use after one month of first opening.
",10
+1625,Moxifloxacin Hydrochloride (Injection),moxifloxacin-hydrochloride-injection-1625,https://medex.com.bd/attachments/keID9BYQHY5jIniBEQlAru8sY6xrsL/moxifloxacin-hydrochloride-injection-prescribing-information,4-Quinolone preparations,Skin and skin sructure infections,"Moxifloxacin infusion is indicated for treating following infections in adults >18 years of age caused by designated, susceptible bacteria.
+
+- Acute Bacterial Sinusitis
+- Acute Bacterial Exacerbation of Chronic Bronchitis
+- Community Acquired Pneumonia
+- Skin and Skin Structure Infections: Uncomplicated and Complicated
+- Complicated Intra-Abdominal Infections.
+
","4-Quinolone preparations
",,"The dose of Moxifloxacin is 400 mg once daily. The duration of therapy depends on the type of infection as described in following:
+
+- Acute Bacterial Sinusitis: 400 mg once daily for 10 days.
+- Acute Bacterial Exacerbation of Chronic Bronchitis: 400 mg once daily for 5 days.
+- Community Acquired Pneumonia: 400 mg once daily for 7-14 days.
+- Uncomplicated Skin and Skin Structure Infections: 400 mg once daily for 7 days.
+- Complicated Skin and Skin Structure Infections: 400 mg once daily for 7-21 days.
+- Complicated Intra-Abdominal Infections: 400 mg once daily for 5-14 days.
+
","Moxifloxacin injection should be administered by intravenous infusion over a period of 60 minutes. Avoid bolus or rapid infusion.
+
+- Check the bag for minute leaks by squeezing the inner bag firmly. If leaks are found, or if seal is not intact, discard the solution.
+- Do not use if the solution is cloudy or a precipitate is present.
+- Do not use flexible bags in series connections.
+- Close flow control clamp of administration set.
+- Remove cover from port at bottom of bag.
+- Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
+- Suspend bag from hanger.
+- Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Moxifloxacin 400 mg intravenous infusion.
+- Open flow control clamp to expel air from set. Close clamp.
+- Regulate the rate of administration with flow control clamp.
+
","There are no data concerning an interaction of intravenous fluoroquinolones with oral antacids, sucralfate, multivitamins, didanosine, or metal cations. However, no fluoroquinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line. Quinolones, including Moxifloxacin, have been reported to enhance the anticoagulant effects of warfarin or its derivatives in the patient population. Although not observed with Moxifloxacin in predinical and clinical trials, the concomitant administration of a nonsteroidal anti-inflammatory drug with a quinolone may increase the risks of CNS stimulation and convulsions. There is limited information available on the potential for a pharmacodynamic interaction in humans between Moxifloxacin and other drugs that prolong the QTc interval of the electrocardiogram. Sotalol, a Class III antiarrhythmic, has been shown to further increase the QTc interval when combined with high doses of intravenous (IV) Moxifloxacin in dogs. Therefore, Moxifloxacin should be avoided with Class IA and Class III antiarrhythmics.
","Moxifloxacin is contraindicated in persons with known hypersensitivity to Moxifloxacin or other quinolone antibacterials .
","Treatment with Moxifloxacin (oral, IV or sequential therapy) may cause some side effects. Common (>1%) side effects include headache, nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, dizziness, pyrexia and insomnia etc. Less common (0.1 to <1%) side effects include neutropenia, palpitations, tachycardia, bradycardia, vertigo, tinnitus, dry mouth, gastritis, edema, fatigue, malaise, hyperglycemia, anorexia, hyperlipidemia, hypoglycemia, dehydration, back pain and arthralgia etc.
","Pregnancy Category C. Because no adequate or well controlled studies have been conducted in pregnant women, Moxifloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Moxifloxacin is excreted in the breast milk of rats. Moxifloxacin may also be excreted in human milk. Because of the potential for serious adverse reactions in infants who are nursing from mothers taking Moxifloxacin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","Fluoroquinolones, including Moxifloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Moxifloxacin, and may range in severity from mild diarrhea to fatal colitis.
","Pediatric patients: Safety and effectiveness in pediatric patients and adolescents less than 18 years of age have not been established.
Geriatric patients: These patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Moxifloxacin. This risk is further increased in patients receiving concomitant corticosteroid therapy.
",,,,"Store below 25°C and protect from light. Avoid extreme heat and freezing. Keep out of reach of children.
",11
+775,Morphine Sulfate,morphine-sulfate-775,https://medex.com.bd/attachments/7zTBSjLKn3pxBCNvJXFAGXYatTY5eu/morphine-sulfate-injection-prescribing-information,Opioid analgesics,Pain associated with myocardial infarction,"This medication is used to help relieve moderate to severe pain. Morphine belongs to a class of drugs known as opioid (narcotic) analgesics. It works in the brain to change how your body feels and responds to pain.
","Opioid analgesics
","Morphine is a phenanthrene derivative which acts mainly on the CNS and smooth muscles. It binds to opiate receptors in the CNS altering pain perception and response. Analgesia, euphoria and dependence are thought to be due to its action at the mu-1 receptors while resp depression and inhibition of intestinal movements are due to action at the mu-2 receptors. Spinal analgesia is mediated by morphine agonist action at the K receptor.
","Oral- Moderate to severe pain: 5-20 mg 4 hrly. Extended-release: 5-20 mg 12 hrly. Dosage is dependent on the severity of pain.
Intraspinal- Moderate to severe pain: Initially, 5 mg epidural inj; after 1 hr, additional doses of 1-2 mg may be given up to a total dose of 10 mg/24 hr if pain relief is unsatisfactory. A dose of 20-30 mg daily may be required in some patients. Liposomal inj: 10-20 mg depending on the type of surgery.
Intrathecal- Moderate to severe pain: 0.2-1 mg once daily or 1-10 mg daily for patients with opioid tolerance. Some patients may require a dose of up to 20 mg daily.
Intravenous- Acute pulmonary oedema:
+
+- Adult: 5-10 mg via slow inj at 2 mg/min.
+- Elderly: Half of the usual adult dose.
+
+
Intravenous- Pain associated with myocardial infarction:
+
+- Adult: 5-10 mg at 1-2 mg/min followed by a further 5-10 mg as necessary.
+- Elderly: Half of the usual adult dose.
+
+
Parenteral-
+
+- Moderate to severe pain: 5-20 mg; 2.5-10 mg via slow IV inj over 4-5 min with patient in recumbent position or a starting dose of 1-2 mg/hr via continuous IV infusion (max: 100 mg/day; 4 g/day in cancer patients). Doses may be adjusted according to severity of pain and patient's response.
+- Premedication in surgery: Up to 10 mg, given 60-90 min before operation.
+
","May be taken with or without food. May be taken with meals to reduce GI discomfort.
","Additive depressant effects with other CNS depressants (e.g. sedatives, hypnotics, general anaesth, phenothiazines, other tranquilisers). May enhance the neuromuscular blocking action of skeletal muscle relaxants. Reduced analgesic effect with mixed agonist/antagonist opioid analgesics (e.g. pentazocine, nalbuphine, buprenorphine). Increased plasma concentrations with cimetidine. May reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. May delay the absorption of mexiletine. May antagonise the GI effect of cisapride, domperidone and metoclopramide. May produce hyperpyrexia and CNS toxicity with dopaminergics.
","Resp depression, obstructive airway disease, delayed gastric emptying, acute abdomen, heart failure secondary to chronic lung disease, known or suspected paralytic ileus, phaeochromocytoma. Concurrent admin with MAOIs or within 2 wk after treatment.
","Nausea, vomiting, constipation, abdominal pain, dry mouth, anorexia, taste disturbance, dyspepsia, resp depression, sedation, dizziness, confusion, insomnia, headache, somnolence, involuntary muscle contractions, hyperhidrosis, rash, pruritus, asthenic conditions, HTN, bronchospasm, seizures, amenorrhoea, rhabdomyolysis, nystagmus.
","Parenteral or oral: C, D (if prolonged use/high doses at term)
","Patient with impaired resp function, severe bronchial asthma, convulsive disorders, acute alcoholism, delirium tremens, raised intracranial pressure, hypotension with hypovolaemia, cardiac arrhythmias, severe cor pulmonale, history of substance abuse, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency, toxic psychoses. Opioid dependent patients. Renal and hepatic impairment. Pregnancy and lactation.
","Renal Impairment: Dosage may need to be reduced.
Hepatic Impairment: Dosage may need to be reduced.
","Symptoms: Resp depression, pinpoint pupils, extreme somnolence progressing to stupor and coma, skeletal muscle flaccidity, cold and clammy skin and sometimes bradycardia and hypotension. Apnoea, circulatory collapse, and cardiac arrest may occur in severe cases.
Management: Re-establish adequate resp exchange through provision of a patent airway and institution of assisted or controlled ventilation. Oxygen, IV fluid, vasopressors and other supportive measures may be employed as necessary. Naloxone may be given as antidote.
",,,"Inj/oral preparations: Store between 15-30°C. Liposomal inj: Store between 2-8°C. Supp: Store below 25°C. Protect from light.
",13
+768,Montelukast Sodium,montelukast-sodium-768,https://medex.com.bd/attachments/uo5XwUttP6MLiht3nd3tM00SM6BsM9/montelukast-sodium-prescribing-information,Leukotriene receptor antagonists,Rhinitis,"Montelukast Sodium is indicated for:
+
+- Prophylaxis and chronic treatment of asthma
+- Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
+- Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis
+
","Leukotriene receptor antagonists
","Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT1). The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.
","Adults & adolescents (15 years & older)-
+
+- Asthma & Allergic Rhinitis: 10 mg/day
+- Exercise-Induced Bronchoconstriction: 10 mg/day
+
+Pediatric patients (6 to 14 years)-
+
+- Asthma & Allergic Rhinitis: 5 mg/day
+- Exercise-Induced Bronchoconstriction: 5 mg/day
+
+Pediatric patients (6 months to 5 years)-
+
+- Asthma & Allergic Rhinitis: 4 mg/day
+- Exercise-Induced Bronchoconstriction: Not recommended
+
+Patients with both asthma and allergic rhinitis should take only one dose daily in the evening. For prevention of Acute prevention of Exercise-Induced Bronchoconstriction, a single dose should be taken at least 2 hours before exercise.
","Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.
","With medicine: No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.
With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.
","Montelukast is contraindicated in patients who are hypersensitive to any component of this product.
","Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.
Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.
Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.
","There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. Montelukast is excreted in breast milk. So caution should be exercised when Montelukast is given to a nursing mother.
","Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatic. Neuropsychiatric events including agitation, hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor.
",,"There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.
",,,"Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.
",12
+774,Monosulfiram,monosulfiram-774,,Parasiticidal preparations,Scabies,"Monosulfiram solution is a parasiticide, active against the burrowing mite Sarcoptes scabiei. It is indicated for the treatment and prophylaxis of scabies.
","Parasiticidal preparations
","Monosulfiram, is an ectoparasiticide used in the treatment and prevention of scabies.
","Before application Monosulfiram Solution should be diluted with two to three parts of water. The patient's body should be liberally washed with soap and water and thoroughly dried. Apart from face and scalp, the entire body should be painted with the dilute solution, which is rubbed well in and left to dry. About ten minutes is allowed for the skin to dry naturally and the patient then dresses. Application is suitable for use in clinics dealing with children. In difficult cases this routine may be repeated successively for two or three days. These instructions are applicable to adults and children.
",,"There are no known drug interactions and none well documented.
","Known idiosyncratic response to its application. The solution should not be applied near a naked flame. Because of the close chemical relationship between monosulfiram and disulfiram, it is advisable to abstain from alcohol before and for at least 48 hours after the application of Monosulfiram
","Very few side-effects occur with Monosulfiram Solution even in cases of undiluted application. A few cases of erythematous rash considered as idiosyncratic response have been reported.
","Pregnancy Category is not Classified. FDA has not yet classified the drug into a specified pregnancy category.
",,,"The solution contains alcohol and monosulfiram, and if ingested this combination will produce a severe reaction with flushing, dyspnoea, headache, dizziness, nausea, vomiting, drowsiness or sleep. Tachycardia and hypotension may also occur and the resultant myocardial ischaemia may be fatal. Symptomatic measures are required supply of oxygen, if dysponea is excessive, and control of the blood pressure. Other treatment which has been found useful includes application of cardiac stimulants, intravenous iron, ascorbic acid and nicotinamide, adenine and intravenous sodium thiosulphate.
",,,"Store at room temperature (below 35° C). Monosulfiram Solution should not be stored in a cold place as this causes deposition of crystals. These can be redissolved by immersing the bottle in warm water. The solution is flammable and should not be kept near naked flame. Water is a suitable diluents for Monosulfiram.
",10
+34,Monosemicarbazone Adrenochrome,monosemicarbazone-adrenochrome-34,https://medex.com.bd/attachments/kR3HMsoUHfHfZ1lVLzwTsaxAWJop2A/monosemicarbazone-adrenochrome-prescribing-information,Anti-fibrinolytic drugs,Secondary hemorrhage,"Monosemicarbazone Adrenochrome is indicated in the prevention and treatment of surgical and non-surgical capillary bleedings.
","Anti-fibrinolytic drugs
","Adrenochrome Monosemicarbazone is a haemostatic with a rapid onset of action. It contains a water soluble form of adrenochrome monosemicarbazone, a stable derivative of adrenochrome as the active substance. Adrenochrome is an oxidation product of adrenaline; it reduces normal and pathologic bleeding time by decreasing capillary permeability. It produces capillary haemostatis without exerting any of the adrenergic actions on respiration or cardiovascular system. Thus, despite its adrenaline like action on small blood vessels, does not give rise to the general systemic effects of sympathomimetic drugs.
","For the prevention and treatment of capillary bleedings, accordingly to the severity of the case, 4-12 tablets divided over the day, preferably one hour before meals. Prior to surgery, medication is started on the preceding evening, either orally or by intramuscular or subcutaneous injection of usually 1.5-5 mg. In addition, an injection is given about half an hour before the surgical intervention.
Injection solution should be administered by intramuscular or subcutaneous route; in emergency cases the injections may be given intravenously. The tablets should be taken orally.
",,"No specific drug interaction has been demonstrated.
","There are no known contraindications.
","No adverse reactions have been reported at the recommended dosages.
","During pregnancy, the benefits of the use of Monosemicarbazone Adrenochrome should be weighed against the possible hazards of the foetus.
","Because of the content of diprophylline (90 mg/ml), the dosage of the 5 mg/ml injection preparation to premature babies, infants and young children should not exceed 0.3 ml.
",,,,,"Store in a cool (in between 2°-25°C), dry place & protect from light. Keep out of the reach of children.
",10
+1782,Monobasic sodium phosphate + Dibasic sodium phosphate,monobasic-sodium-phosphate-dibasic-sodium-phosphate-1782,https://medex.com.bd/attachments/vMF3p2GS23LIYWXkM9NmnPw1ArZYRE/monobasic-sodium-phosphate-dibasic-sodium-phosphate-prescribing-information,Other laxative preparations,Constipation,"This is used for relief of occasional constipation. This product usually produces a bowel movement in 1 to 5 minutes.
","Other laxative preparations
",,"Adults and children, 12 years and over: One Bottle per day.
Children between 2 and 11 years: Use this laxative preparation.
Children under 2 years: Do not use.
If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.
","
+- Remove the orange protective shield from this before inserting.
+- With steady pressure, gently insert this bottle tip into the rectum with a slight side-to-side movement, with the tip pointing toward the navel. Insertion may be easier if the person receiving this bears down as if having a bowel movement. This helps relax the muscles around the anus.
+- Stop using if the tip is hard to insert. Forcing the tip into the rectum can cause injury (especially if you have hemorrhoids). If this bottle tip causes rectal bleeding or pain, get immediate medical care.
+- Squeeze bottle until nearly all liquid is gone. It is not necessary to empty the bottle completely, as it contains more liquid than needed.
+- Remove the tip from the rectum and maintain position until the urge to evacuate is strong (usually 1 to 5 minutes).
+
+Positions for using this:
+
+- Left-side position: Lie on left side with knee bent, and arms resting comfortably.
+- Knee-chest position: kneel, then lower head and chest forward until left side of face is resting on surface with left arm folded comfortably.
+
+If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.
",,"Using more than one bottle in 24 hours can be harmful. Do not use without asking a doctor:
+
+- For more than 3 days
+- If you have kidney disease
+- If you have heart problems
+- If you are dehydrated
+- When abdominal pain, nausea, or vomiting are present.
+
",,"If pregnant or breastfeeding, ask a health professional before use.
","Ask a doctor before using this product if you:
+
+- Are 55 years old or older
+- Are on a sodium-restricted diet
+- Have a sudden change in bowel habits lasting more than 2 weeks
+- Already used a laxative for more than 1 week
+
+Stop use and ask a doctor if you have:
+
+- Rectal bleeding
+- No bowel movement or no liquid comes out of the rectum after 30 minutes
+- Symptoms of dehydration (feeling thirsty, dizziness, vomiting, urinating less often than normal)
+
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
",8
+1791,Mometasone Furoate + Formoterol Fumarate,mometasone-furoate-formoterol-fumarate-1791,,,,"This inhaler is used for asthma as follows:
+
+- This inhaler is a prescription medicine used to control symptoms of asthma and prevent symptoms such as wheezing in people 12 years of age and older.
+- This inhaler contains Formoterol which is a Long Acting β2 Agonist (LABA). When it is used alone increase the risk of hospitalizations and death from asthma problems. This contains an ICS and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.
... Read more
This inhaler is used for asthma as follows:
+
+- This inhaler is a prescription medicine used to control symptoms of asthma and prevent symptoms such as wheezing in people 12 years of age and older.
+- This inhaler contains Formoterol which is a Long Acting β2 Agonist (LABA). When it is used alone increase the risk of hospitalizations and death from asthma problems. This contains an ICS and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.
+- This inhaler is not for adults and adolescent patients with asthma who are well controlled with an asthma control medicine, such as a low to medium dose ICS medicine. This inhaler is for adults and adolescent patients with asthma who need both an ICS and LABA medicine.
+
",,"Mometasone furoate is an inhaled corticosteroid- ICS for short. Inhaled corticosteroids help to decrease inflammation in the lungs. Infammation in the lungs can lead to breathing problems. Formoterol fumarate is a long-acting beta-2 agonist- LABA for short. LABA medicines help the muscles around the airways of the lungs stay relaxed to prevent asthma symptoms, such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe.
","Adult and adolescent patients aged 12 Years and older: Dosage is either 2 inhalations twice daily of 200 HFA inhaler or 100 HFA inhaler. When choosing the starting dosage strength of this inhaler, consider the patients' disease severity, based on their previous asthma therapy, including the inhaled corticosteroid dosage, as well as the patients' current control of asthma symptoms and risk of future exacerbation. The maximum recommended dosage is two inhalations of 200 HFA inhaler twice daily (maximum daily dosage 800 mcg/20 mcg). After each dose of 2 puffs, rinse your mouth with water. Spit out the water. Do not swallow it. This will help to prevent thrush in your mouth or throat.
","
+- Remove the cap and shake the inhaler vigorously before each use.
+- Holding the inhaler well away from your mouth, breathe out gently (but not fully).
+- Place the mouthpiece in your mouth and close your lips around it.
+- After starting to breathe in slowly and deeply through your mouth, press the metal canister firmly to release the powder, and continue to breathe in.
+- Remove the inhaler from your mouth and hold your breath for 10 seconds, or as long as it is comfortable, then breathe out slowly.
+- If you take a second inhalation, you should wait for at least one minute before repeating steps 2, 3 and 4. After use replace the cap on the mouthpiece.
+- Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 2 carefully.
+- It is very important that the plastic mouthpiece is to be cleaned regularly to prevent build-up of spare powder. Remove the metal canister and wash the plastic mouthpiece in warm water at least twice a week. Leave to dry in a warm place overnight. No harm will come with from washing the mouthpiece every day. For further assistance / information please consult with your physician.
+
","
+- Strong cytochrome P450 3A4 inhibitors: Use with caution. May cause increased systemic corticosteroid effects.
+- Adrenergic agents: Use with caution. Additional adrenergic drugs may potentiate sympathetic effects
+- Xanthine derivatives and diuretics: Use with caution. May potentiate ECG changes and/or hypokalemia.
+- MAO inhibitors, tricyclic antidepressants, macrolides, and drugs that prolong QTc interval: Use with extreme caution. May potentiate effect on the cardiovascular system.
+- Beta-blockers: Use with caution and only when medically necessary. May decrease effectiveness and produce severe bronchospasm.
+- Halogenated hydrocarbons: There is an elevated risk of arrhythmias in patients receiving concomitant anesthesia with halogenated hydrocarbons.
+
","This combination is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. This combination is contraindicated in patients with known hypersensitivity to Mometasone Furoate, Formoterol Fumarate, or any of the ingredients in this combination.
","The most common side effects of this combination include inflammation of the nose and throat, inflammation of the sinuses, headache, flu, and upper respiratory infection. Other less common side-effects include: serious allergic reactions, thrush in the mouth & throat, reduces adrenal function, increase in wheezing, lower bone mineral density in osteoporosis patient, slowed growth in children, glaucoma, blurred vision & hypokalemia.
","The use of this combination during pregnancy and lactation should be restricted to those patients in whom the benefits clearly outweigh the risk.
",,"Hepatic/Renal Impairment: There are no data regarding the specific use of this combination in patients with hepatic or renal impairment.
Geriatrics: The pharmacokinetics of this combination have not been specifically studied in the elderly population.
",,,,"Keep out of the reach of children. Store below 30°C protected from direct sunlight and heat. Keep away from contact of eyes. The container should not be punctured, broken or burnt even when apparently empty.
",10
+1328,Mometasone Furoate (Topical),mometasone-furoate-topical-1328,https://medex.com.bd/attachments/puVapgXLgSkfeU0QqzbZyMOcIqtwSo/mometasone-furoate-topical-prescribing-information,Other Topical corticosteroids,Psoriasis,"Mometasone cream is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses, such as psoriasis and atopic dermatitis.
","Other Topical corticosteroids
","Mometasone is a corticosteroid demonstrating anti-inflammatory properties. The precise mechanism of corticosteroids action on allergic rhinitis is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation.
","A thin film of Mometasone Furoate cream should be applied to the affected skin areas once daily. Safety and effectiveness in paediatric patients below 2 years of age have not been established.
",,,"The drug is contraindicated in individuals with a history of sensitivity reactions to Mometasone or any of the components of the preparation.
","Mometasone Furoate cream is generally well tolerated. Burning, Pruritus and skin atrophy may occur.
","Pregnancy: There is no adequate and well-controlled studies in pregnant women.
Lactation: It is not known whether this drug passes into breast milk.
","If irritation develops with the use of Mometasone Furoate cream, treatment should be discontinued.
",,,,,,8
+1327,Mometasone Furoate (Nasal Spray),mometasone-furoate-nasal-spray-1327,https://medex.com.bd/attachments/UdtFFTYU2MzmAQCpGQDsEgHuygVyR4/mometasone-furoate-nasal-spray-prescribing-information,Nasal Steroid Preparations,Perennial or seasonal allergic rhinitis,"Mometasone Furoate Nasal Spray is indicated for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis, in adults and pediatric patients 2 years of age and older. It is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and adolescent ... Read more
Mometasone Furoate Nasal Spray is indicated for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis, in adults and pediatric patients 2 years of age and older. It is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and adolescent patients 12 years and older. It is also indicated for the treatment of nasal polyps in patients 18 years and older.
","Nasal Steroid Preparations
","Mometasone Furoate monohydrate is a corticosteroid demonstrating antiinflammatory properties. The precise mechanism of corticosteroid action on allergic rhinitis is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (eg, mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (eg, histamines, eicosanoids, leukotrienes, and cytokines) involved in inflammation. Protein binding for Mometasone Furoate was reported to be 98% to 99% in concentration range of 5 to 500 ng/mL.The effective plasma elimination half life of Mometasone Furoate is 5.8 hours.
","Allergic Rhinitis-
+
+- Adults and Children 12 Years of Age and Older: The recommended dose for prophylaxis and treatment of the nasal symptoms of seasonal allergic rhinitis and treatment of the nasal symptoms of perennial allergic rhinitis is two sprays (50 mcg of Mometasone Furoate in each spray) in each nostril once daily (total daily dose of 100 mcg). In patients with a known seasonal allergen that precipitates nasal symptoms of seasonal allergic rhinitis, prophylaxis with Mometasone Nasal Spray, 50 mcg (200 mcg/day) isrecommended 2 to 4 weeks prior to the anticipated start of the pollen season.
+- Children 2 to 11 Years of Age: The recommended dose fortreatment ofthe nasalsymptoms of seasonal and perennial allergic rhinitis is one spray (50 mcg of Mometasone Furoate in each spray) in each nostril once daily (total daily dose of 100 mcg).
+
+Nasal Polyps Adults-
+
+- 18 years of Age and Older: The recommended dose for nasal polyps is two sprays (50 mcg of Mometasone Furoate in each spray) in each nostril twice daily (total daily dose of 400 mcg). A dose of two sprays (50 mcg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 200 mcg) is also effective in some patients.
+
","How to use the Nasal Spray-
+
+- Shake the bottle gently and remove the dust cover.
+- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
+- Gently blow the nose to clear the nostrils.
+- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
+- Breathe out through your mouth.
+- Repeat the above steps in the same/ other nostril for consecutive doses.
+
+Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-
+
+- Remove the dust cover.
+- Gently pull off the nasal applicator.
+- Wash the applicator and dust cover in warm water.
+- Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
+- Gently push the applicator back on the top of the bottle and re-fix the dust cover.
+
","There are no drug interactions of note with Mometasone Furoate.
","Hypersensitivity to any of the ingredients of this preparation contraindicates its use.
","Side effects are generally mild and included headache, viral infection, sore throat, nosebleeds, and coughing.
","There are no adequate and well-controlled studies in pregnant women. Mometasone Furoate, like other corticosteroids, should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. It is not known if Mometasone Furoate is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be used when Mometasone is administered to nursing women.
","While using nasal corticosteroids, caution is required in patients with active or dormant tuberculous infection, or in untreated fungal, bacterial, systemic viral infections, or ocular herpes simplex.
",,"There are no data available on the effects of acute or chronic overdosage with Mometasone. Because of low systemic bioavailability, and an absence of acute drugrelated systemic findings in clinical studies, overdose is unlikely to require any therapy other than observation.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+767,Mometasone Furoate (Inhalation Capsule),mometasone-furoate-inhalation-capsule-767,https://medex.com.bd/attachments/JoZbdwFfQiSmVUAyPHeEprpBNtyuEF/mometasone-furoate-inhalation-capsule-prescribing-information,Corticosteroid,Asthma,"Mometasone Furoate is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older. It is not indicated for the relief of acute bronchospasm. It is not indicated in children less than 4 years of age.
","Corticosteroid, Respiratory corticosteroids
","Mometasone is a corticosteroid demonstrating anti-inflammatory properties. The precise mechanism of corticosteroids action on allergic rhinitis is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation.
","Recommended Dosages in Patients 4 Years of Age and Older.
Previous Therapy: Patients ≥ 12 years who received bronchodilators alone
+
+- Recommended Starting Dose: 220 µg once daily in the evening
+- Highest Recommended Daily: 220 µg twice daily or as 440 µg once daily
+
+
Previous Therapy: Patients ≥ 12 years who received inhaled corticosteroids
+
+- Recommended Starting Dose: 220 µg once daily
+- Highest Recommended Daily: 440 µg once daily or 440 µg twice daily.
+
+
Previous Therapy: Patients ≥ 12 years who received oral corticosteroids
+
+- Recommended Starting Dose: 4400 µg once daily
+- Highest Recommended Daily: 440 µg once daily or 440 µg twice daily.
+
",,"Ketoconazole, a strong inhibitor of cytochrome P4503A4 may increase plasma levels of Mometasone Furoate during concomitant dosing.
","Hypersensitivity to any of the ingredients of this preparation contraindicates its use. Mometasone Furoate therapy is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
","Generally side effects are mild like headache, viral infection, sore throat, nosebleeds and coughing. Systemic and local corticosteroid use may result few side effects like candida infection, immunosuppression, hypercorticism, adrenal suppression, growth effects, glaucoma and cataracts.
","Pregnancy: There are no adequate and well-controlled studies in pregnant women. Mometasone Furoate, like other corticosteroids should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.
Lactation: It is not known if Mometasone Furoate is excreted in human milk. Since other corticosteroids are excreted in human milk, caution should be used when Mometasone Furoate is administered to nursing women.
","Use with caution in active or inactive tuberculosis infection, herpes simplex virus infection of the eye, untreated infections affecting the body as a whole etc.
",,"There are no data available on the effects of acute or chronic over dosage with Mometasone Furoate. Because of low systemic bioavailability and an absence of acute drug-related systemic findings in clinical studies, overdose is unlikely to require any therapy other than observation.
",,,"Protect from light, store in cool & dry place. Do not store above 30° C. Keep out of the reach of children. Protect from freezing. Insert the Inhalation Capsule or ConviCap in the ConviHaler just prior to use to protect from deterioration by moisture
",11
+1968,Molnupiravir,molnupiravir-1968,https://medex.com.bd/attachments/FVo7ECRhMOJHxCEgZdYrd7piWldpXR/molnupiravir-prescribing-information,,,"Molnupiravir is an antiviral medicine used to treat mild to moderate C0VID-19 (caused by SARS-CoV-2) in adults who are at risk for developing severe illness. Molnupiravir may help people with C0VID-19 stay out of the hospital and feel better. Emergency use authorized oral therapeutic for the treatment ... Read more
Molnupiravir is an antiviral medicine used to treat mild to moderate C0VID-19 (caused by SARS-CoV-2) in adults who are at risk for developing severe illness. Molnupiravir may help people with C0VID-19 stay out of the hospital and feel better. Emergency use authorized oral therapeutic for the treatment of C0VID-19 in Non-hospitalized patients with mild or moderate disease.
Asymptomatic or pre-symptomatic Infection: Individuals who test positive for SARS-CoV-2 by virologic testing using a molecular diagnostic (e.g., polymerase chain reaction) or antigen test, but have no symptoms.
Mild illness: individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain) without shortness of breath, dyspnoea, or abnormal chest imaging.
Moderate illness: Individuals who have evidence of lower respiratory disease by clinical assessment or imaging and saturation of oxygen (Sp02) >94% on room air at sea level.
Severe illness: Individuals who have respiratory frequency >30 breaths per minute, Sp02 <94% on room air at sea level, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (Pa02/Fi02) <300 mmHg, or lung infiltrates >50%.
Critical illness: individuals who have respiratory failure, septic shock, and/or multiple organ dysfunction.
",,"Molnupiravir inhibits viral reproduction by promoting widespread mutations in the replication of viral RNA by RNA-directed RNA polymerase. It is metabolized into a ribonucleoside analog that resembles cytidine, β-D-N 4-Hydroxycytidine 5′-triphosphate (also called EIDD-1931 5′-triphosphate or NHC-TP). During replication, the virus's enzyme incorporates NHC-TP into newly-made RNA instead of using real cytidine.
Molnupiravir can swap between two forms (tautomers), one of which mimics cytidine (C) and the other of which mimics uridine (U). NHC-TP is not recognized as an error by the virus' proofreading exonuclease enzymes, which can replace mutated nucleotides with corrected versions. When the viral RNA polymerase attempts to copy RNA containing molnupiravir, it sometimes interprets it as C and sometimes as U. This causes more mutations in all downstream copies than the virus can survive, an effect called viral error catastrophe or lethal mutagenesis.
","The recommended dose of Molnupiravir is four 200 mg capsules (4+0+4), every 12 hours for 5 days. Do not give this medicine to children and adolescents aged less than 18 years. The use of Molnupiravir in persons aged less than 18 years has not yet been studied.
",,"No drug interactions have been identified based on the limited available data. No clinical interaction studies have been performed with Molnupiravir. Molnupiravir is hydrolysed to n-hydroxycytidine (NHC) prior to reaching systemic circulation. Uptake of NHC and metabolism to NHC-TP are mediated by the same pathways involved in endogenous pyrimidine metabolism. NHC is not a substrate of major drug metabolising enzymes or transporters. Based on in vitro studies, neither molnupiravir nor NHC are inhibitors or inducers of major drug metabolising enzymes or inhibitors of major drug transporters. Therefore, the potential for molnupiravir or NHC to interact with concomitant medications is considered unlikely.
","Molnupiravir is contraindicated in patients with known hypersensitivity to Molnupiravir.
","Common side effects include diarrhoea, nausea, feeling dizzy, headache.
","Animal studies with molnupiravir have shown harmful effects to the unborn animal. Molnupiravir is not recommended in pregnancy. Molnupiravir has not been studied in pregnancy and it is not known if Molnupiravir will harm your baby while you are pregnant. If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice. If you can become pregnant, you should use effective birth control while you are taking Molnupiravir and for 4 days after the last dose of Molnupiravir. If you are breast-feeding or are planning to breastfeed, tell your doctor before taking this medicine. Breast-feeding is not recommended during treatment and for 4 days after the last dose of Molnupiravir. This is because it is not known if Molnupiravir gets into breast milk and will be passed to the baby.
","There are limited clinical data available for Molnupiravir. Serious and unexpected adverse events may occur that have not been previously reported with Molnupiravir use.
",,,,,"Store at or below 25°C temperature. Keep away from light and wet places. Keep out of reach of children.
",9
+766,Mizolastine,mizolastine-766,,Non-sedating antihistamines,Allergic conditions,"Mizolastine is indicated for the symptomatic relief of the following conditions:
+
+- Seasonal allergic rhinoconjunctivitis (hay fever)
+- Perennial allergic rhinoconjunctivitis
+- Urticaria
+
","Non-sedating antihistamines
","Mizolastine, a non-sedating antihistamine, blocks histamine H1-receptors on effector cells of the GI tract, blood vessels and respiratory tract. It also has mast-cell stabilising properties.
","Adult and children above 12 years: The usual recommended dose is one 10 mg tablet daily.
Children below 12 years: Not recommended.
",,"Systemically administered Ketoconazole and Erythromycin, antiarrythmics e.g. Amiodarone moderately increase the plasma concentration of Mizolastine. This could increase the risk of arrythmias. Concurrent use of other potent inhibitor of the cytochrome P 450 3A4 enzyme e.g. Ciclosporin should be approached with caution. No potentiation of the sedation and the alteration in performance caused by alcohol with Mizolastine has been observed.
","Mizolastine is contra-indicated in patients with clinically significant cardiac disease or a history of symptomatic arrhythmias and in patients with known or suspected QT prolongation, patients with electrolyte imbalance (particularly hypokalaemia), and in those with clinically significant bradycardia. It is also contra-indicated in patients taking other drugs that decrease its metabolism, patients with significantly impaired liver function, and in patients who are hypersensitive to the drug.
","Mizolastine is well tolerated in the recommended doses. The usual side effects are dry mouth, diarrhoea, abdominal pain, nausea, drowsiness, headache, dizziness, raised liver enzymes, hypotension, tachycardia and palpitations. Bronchospasm and aggravation of asthma were reported, but in view of the high frequency of asthma in the treated patient population, a causality relationship remains uncertain.
","The safety of Mizolastine for use in human pregnancy has not been established. The evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to the development of the embryo or foetus, the course of gestation and peri and post-natal development. Mizolastine should be avoided in pregnancy (particularly the 1 st trimester). Mizolastine is excreted into breast milk, therefore it is not recommended during lactation.
","Patients should be warned that a small number of individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated task.
",,"In cases of overdosage, general symptomatic surveillance with cardiac monitoring including QT interval and cardiac rhythm for at least 24 hours is recommended, along with standard measures to remove any unabsorbed drug. Studies in patients with renal insufficiency suggest that haemodialysis does not increase clearance of the drug.
",,,"Store in a cool & dry place. Protect from light. It should be kept out of the reach of children.
",11
+1442,Mycophenolic acid,mycophenolic-acid-1442,https://medex.com.bd/attachments/LWAcTd5ijFTXLeRnVmEM8vDR05rbJM/mycophenolic-acid-prescribing-information,Immunosuppressant,Receiving a kidney transplant,"Prophylaxis of organ rejection in kidney transplant: Mycophenolic acid is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. It is indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant.
","Immunosuppressant
","Mycophenolic acid delayed-release tablets are enteric coated formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid. It is an immunosuppressive agent. It is an uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH). Therefore, it inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation to DNA. Mycophenolic acid has cytostatic effects on lymphocytes. It has been shown to prevent the occurrence of acute rejection of kidney and heart allotransplantation. It also decreases antibody production.
","Dosage in adult kidney transplant patients: The recommended dose of Mycophenolic acid is 720 mg administered twice daily (1440 mg total daily dose).
Dosage in pediatric kidney transplant patients: The recommended dose of Mycophenolic acid in conversion (at least 6 months post-transplant) pediatric patients age 5 years and older is 400 mg/m2 body surface area (BSA) administered twice daily (up to a maximum dose of 720 mg administered twice daily). Pediatric patients with a BSA of 1.19 to 1.58 m2 may be dosed either with three Mycophenolic acid 180 mg tablets, or one 180 mg tablet plus one 360 mg tablet twice daily (1080 mg daily dose). Patients with a BSA of >1.58 m2 may be dosed either with four Mycophenolic acid 180 mg tablets, or two Mycophenolic acid 360 mg tablets twice daily (1440 mg daily dose).
Mycophenolic acid tablets should be taken on an empty stomach, 1 hour before or 2 hours after food intake. Tablets should not be crushed, chewed, or cut prior to ingesting. The tablets should be swallowed whole in order to maintain the integrity of the enteric coating.
",,"Caution should be exercised with concomitant administration of Antacids, Azathioprine, Cyclosporin, Rifampin, Sevelamer, Cholestyramine, Acyclovir, Metronidazole, Hormonal contraceptives as these medicines may decrease Mycophenolic acid concentration.
","Mycophenolic acid delayed-release tablets and Mycophenolate mofetil tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent.
","The most common adverse reactions (≥20%) associated with the administration of Mycophenolic acid are anemia, leukopenia, constipation, diarrhea, vomiting, dyspepsia, urinary tract infection, CMV infection, insomnia, and postoperative pain.
","Pregnancy Category D. Can cause fetal harm.
Lactation: Discontinue Mycophenolic acid or discontinue nursing while on treatment or within 6 weeks after stopping therapy. Take into consideration the importance of the drug to the mother.
","Mycophenolic acid tablets are used with caution because it-
+
+- Can cause embryofetal toxicity
+- Can increase new or reactive viral infections
+- Can cause blood dyscrasias including pure red cell aplasia
+- Can cause serious GI tract complications (gastrointestinal bleeding, perforations and ulcers)
+- May increase the risk of developing lymphomas and other malignancies, particularly of the skin
+- Use of live vaccine should be avoided during treatment with Mycophenolic acid
+
",,"No data are available with regard to overdose.
",,,"Store at 25° C and Keep out of reach of children.
",11
+789,Mycophenolate Mofetil,mycophenolate-mofetil-789,https://medex.com.bd/attachments/fCS17OrcayPXTL1h3m6Fee1A8IhMoR/mycophenolate-mofetil-film-coated-tablet-prescribing-information,Immunosuppressant,Vasculitis,"Mycophenolate Mofetil in combination with corticosteroids and either ciclosporin or tacrolimus is indicated for-
+
+- Prophylaxis of acute organ rejection and treatment of first or refractory organ rejection in patients receiving allogeneic renal transplants.
+- Prophylaxis of acute organ rejection in patients receiving allogeneic cardiac transplants.
... Read more
Mycophenolate Mofetil in combination with corticosteroids and either ciclosporin or tacrolimus is indicated for-
+
+- Prophylaxis of acute organ rejection and treatment of first or refractory organ rejection in patients receiving allogeneic renal transplants.
+- Prophylaxis of acute organ rejection in patients receiving allogeneic cardiac transplants.
+- Prophylaxis of acute organ rejection in patients receiving allogeneic hepatic transplants.
+- Mycophenolate Mofetil is indicated for induction and maintenance therapy of patients with Class III-V lupus nephritis (diagnosed according to International Society of Nephrology/Renal Pathology Society classification.
+
","Immunological Chemotherapy, Immunosuppressant
","Mechanism of Action: Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic acid (MPA). MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine nucleotide synthesis. The mechanism by which MPA inhibits the enzymatic activity of IMPDH appears to be related to the ability of MPA to structurally mimic both nicotinamide adenine dinucleotide cofactor and a catalytic water molecule. This prevents the oxidation of IMP to xanthose-5’-monophosphate which is the committed step in de novo guanosine nucleotide biosynthesis. MPA has more potent cytostatic effects on lymphocytes than on other cells because T- and B lymphocytes are critically dependent for their proliferation on de novo synthesis of purines whereas other cell types can utilize salvage pathways.
Pharmacodynamics: Mycophenolic acid, the active metabolite of mycophenolate mofetil, is a non-competitive, reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH). Inhibition of IMPDH blocks the de novo synthesis of guanosine nucleotides which are necessary substrates for DNA and RNA synthesis. Unlike other cell types which can use the salvage pathway, B and T lymphocytes are dependent upon the de novo pathway for the generation of guanosine. Data from in vitro studies indicate that mycophenolic acid and/or mycophenolate mofetil inhibit mixed lymphocyte responses and human peripheral blood lymphocyte proliferation induced by a variety of mitogens and antigens. Mycophenolic acid decreases intracellular pools of guanosine triphosphate (GTP) and deoxyguanosine triphosphate (dGTP) in mitogen-stimulated human peripheral blood monocytes or T lymphocytic cell lines but has no effect on GTP concentrations in human neutrophils.
","Transplant patients:Standard dosage for prophylaxis of renal rejection
+
+- Adults: A dose of 1 g administered orally twice a day (daily dose of 2 g) is recommended for use in renal transplant patients.
+- Children (aged 3 months to 18 years): Patients with a body surface area of 1.25 to 1.5 m2 may be prescribed Mycophenolate Mofetil Tablets at a dose of 750 mg twice daily (1.5 g daily dose). Patients with a body surface area >1.5 m2 may be prescribed Mycophenolate Mofetil tablets at a dose of 1 gm twice daily (2 g daily dose).
+
+Standard dosage for prophylaxis of cardiac rejection-
+
+- Adults: A dose of 1.5 g administered orally (over not less than 2 hour) twice a day (daily dose of 3 g) is recommended for use in cardiac transplant patients.
+- Children: no data are available for pediatric cardiac transplant patients.
+
+Standard dosage for prophylaxis of hepatic rejection-
+
+- Adults: A dose of 1.5 g orally twice a day (daily dose of 3 g) is recommended for use in hepatic transplant patients
+- Children: no data are available for pediatric hepatic transplant patients.
+
+Standard dosage for treatment of first or refractory renal rejection-
+
+- Adults: A dose of 1.5 g administered orally twice a day (daily dose of 3 g) is recommended for management of first or refractory rejection.
+- Children: no data are available for the treatment of first or refractory renal rejection in pediatric renal transplant patients.
+
+
Lupus nephritis patients:Standard Dosage for Induction Therapy-
+
+- Adults: A dose of 750 mg-1.5 g administered orally twice a day (daily dose of up to 3 g) is recommended
+- Children: A dose of 600 mg/m2 administered orally twice a day (up to a maximum of 2 g daily) is recommended
+
+Standard Dosage for Maintenance Therapy-
+
+- Adults: A dose of 500 mg-1 g administered orally twice a day is recommended
+- Children: A dose of 300 mg/m2 administered orally twice a day is recommended
+
+Mycophenolate Mofetil should be used in combination with corticosteroids. Doses should be introduced gradually and adjusted according to clinical response. Therapeutic drug monitoring could help prevent sub-therapeutic exposure (Cmin≥3.0 mg/L or inter-dose AUC ≥35 h*mg/L).
",,"Caution should be exercised with concomitant administration of Antacids, Azathioprine, Cyclosporin, Rifampin, Sevelamer, Cholestyramine, Acyclovir, Metronidazole, Hormonal contraceptives as these medicines may decrease Mycophenolic acid concentration.
","Mycophenolic acid is contraindicated in patients with a hypersensitivity to mycophenolic acid, or to any of its excipients. Mycophenolic acid is contraindicated during pregnancy due to its mutagenic and teratogenic potential. Mycophenolic acid is contraindicated in women who are breastfeeding.
","The principal adverse reactions associated with the administration of Mycophenolate Mofetil includes diarrhea, leukopenia, sepsis, gastrointestinal candidiasis, urinary tract infection, herpes simplex, vomiting and there is evidence of a higher frequency of certain types of infections eg. opportunistic infections.
","Mycophenolate Mofetil is contraindicated in pregnancy and during breastfeeding. The safe use of Mycophenolate Mofetil during labor and delivery has not been established.
","Mycophenolic acid tablets are used with caution because it-
+
+- Can increase new or reactive viral infections. Such infections include latent viral reactivation, such as hepatitis B or hepatitis C reactivation, or infections caused by polyomaviruses.
+- Can cause blood dyscrasias including pure red cell aplasia (PRCA).
+- Can cause serious GI tract complications (gastrointestinal bleeding, perforations and ulcers).
+- May increase the risk of developing lymphomas and other malignancies, particularly of the skin.
+- Use of live vaccines should be avoided during treatment with Mycophenolic acid.
+- Patients should not donate blood during therapy.
+
","Geriatric population: Geriatric patients may be at an increased risk of adverse events such as certain infections (including cytomegalovirus tissue invasive disease) and possibly gastrointestinal hemorrhage and pulmonary edema, compared with younger individuals.
","In many of these cases no adverse events were reported. It is expected that an overdose of mycophenolate mofetil could possibly result in over suppression of the immune system and increase susceptibility to infections and bone marrow suppression. If neutropenia develops, dosing with Mycophenolate Mofetil should be interrupted or the dose reduced.
",,,"Store in a cool (below 30°C), dry place and away from light. Keep out of the reach of children.
",12
+788,Mupirocin,mupirocin-788,https://medex.com.bd/attachments/16yHWTLPm825SueTRjxN48q1qJ4dlA/mupirocin-cream-prescribing-information,Topical Antibiotic preparations,Superficial skin infections,"Mupirocin ointment is indicated for the topical treatment of impetigo (skin diseases) due to Staphylococcus aureus and Streptococcus pyogenes. It is also indicated in folliculitis, furunculosis.
","Topical Antibiotic preparations
","Mupirocin is a naturally occurring antibiotic. This antibacterial agent is produced by fermentation using the organism Pseudomonas fluorescens. It is active against a wide range of bacteria (e.g. Staphylococcus aureus including methicillin-resistant strains and Streptococcus pyogenes) those responsible for the majority of skin infections. It is also active against gram-negative pathogens, such as Escherichia coli and Haemophilus influenzae. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase.
","A small amount of Bactropen ointment should be applied to the affected area 3 times daily for up to 10 days. The safety and effectiveness of Mupirocin ointment have been established in the age range of 2 months to 16 years.
",,"No drug interaction has been identified with Mupirocin ointment.
","The drug is contraindicated in individuals with a history of hypersensitivity reactions to Mupirocin or any of the components of the preparation.
","Reported side effects are burning, stinging or pain, itching and some patient may be suffered rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis and increased exudate.
","Reproduction studies on Mupirocin ointment in animals have revealed no evidence of harm to the foetus. As there is no clinical experience on it’s use during pregnancy, Mupirocin ointment should only be used in pregnancy when the potential benefits outweigh the possible risks of treatment.
It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mupirocin ointment is administered to a nursing woman.
","Mupirocin ointment is not for ophthalmic or intra-nasal use. As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. When Mupirocin is used on the face care should be taken to avoid the eyes. This is not suitable in conjunction with cannulae and at the site of central venous cannulation. In the event of a sensitization or severe local irritation from Mupirocin ointment, usage should be discontinued and appropriate alternative therapy for the infection instituted. Mixing of Mupirocin ointment with other preparations causes risk of dilution, resulting in a reduction of the antibacterial activity and potential loss of stability of the Mupirocin in the ointment.
",,"There is currently limited data with overdose of Mupirocin ointment. In the event of overdose, the patient should be treated supportively with appropriate monitoring as necessary.
",,,"Keep below 25° C temperature, protected from light and moisture. Do not keep in freeze. Keep out of the reach of children.
",11
+1202,Multivitamins & Multiminerals [A-Z prenatal preparation],multivitamins-multiminerals-a-z-prenatal-preparation-1202,,"Iron, Vitamin & Mineral Combined preparation",Vitamin deficiency,"This is indicated for use in improving the nutritional status of women throughout the pregnancy and in the postnatal period for both lactating and non-lactating mothers. This is also indicated in improving the nutritional status of women prior to conception.
","Iron, Vitamin & Mineral Combined preparation, Multi-vitamin & Multi-mineral combined preparations
","This Multivitamins & Multiminerals is a preparation of comprehensive multiple vitamin and mineral supplement designed to meet the increased nutritional needs of pregnant or lactating women. Since pregnancy and lactation impose an increased demand for certain nutrients, added insurance of a complete multiple vitamin and nutrient supplement is recommended.
The special formulation of This Multivitamins & Multiminerals provides a wide spectrum of the essential nutrients needed for pregnant women, in a form that is gentle to the sensitive stomach. is a preparation of comprehensive multiple vitamin and mineral supplement designed to meet the increased nutritional needs of pregnant or lactating women. Since pregnancy and lactation impose an increased demand for certain nutrients, added insurance of a complete multiple vitamin and nutrient supplement is recommended. The special formulation of This Multivitamins & Multiminerals provides a wide spectrum of the essential nutrients needed for pregnant women, in a form that is gentle to the sensitive stomach.
","One tablet daily or as directed by the physician.
",,,"This Multivitamins & Multiminerals is contraindicated in patients with a known hypersensitivity to any of the ingredients.
","Allergic sensitization has been reported following oral administration of folic acid.
","Recommended.
","Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive
",,"Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. In case of accidental overdose, call a doctor or poison control center immediately.
",,,,9
+840,Multivitamin with L-Lysine,multivitamin-with-l-lysine-840,,Specific combined vitamin preparations,Weight gain and calcium retention,"Multivitamin with L-Lysine is indicated in-
+
+- Improves appetite
+- Promotes growth in height & weight
+- Helps in building of muscle protein
+- Helps to absorb Calcium
+- Ensures energy production
+
","Specific combined vitamin preparations
",,"Adult: 03 Tablets daily
Children (from 01 year of age): 1-3 Tablets daily depending on the age & physical condition
",,,"The product is contraindicated in patients with a known hypersensitivity to any of the active ingredients of the product.
","The product is usually well tolerated and exerts no untoward effects if taken in the dosage recommended.
","The specific information is not available in this respect.
",,,,,,"Keep container well closed after taking medicine. Store below 25°C. Protect from light & moisture. Keep out of reach of children.
",7
+1660,Multivitamin & Normal Saline,multivitamin-normal-saline-1660,,Multi-vitamin & Multi-mineral combined preparations,Mild diarrhea,"This is intended as a supplement for intravenous nutrition in order to meet the daily requirements of the water-soluble vitamins of dehydrated patients.
","Multi-vitamin & Multi-mineral combined preparations
","This is a sterile, lyophilized powder of water-soluble vitamins for infusion. It contains balanced amount of all the important water soluble vitamins which act as coenzymes of vital enzymes associated with crucial physiological processes, energy metabolism, cell growth and replenishment especially in brain and nerve cells. Vitamin C acts as an antioxidant and helps in collagen formation. Intravenous administration of this combination gives prompt action.
","Adults and children weighing 10 kg or more: 1 vial (10 ml) daily.
Children weighing less than 10 kg: should be given 1 ml of the dissolved mixture per kg body weight/day.
","The contents of one vial are dissolved by the aseptic addition of 10 ml of one of the following:
+
+- Water for injection
+- Fat emulsion 10%
+- Glucose solution for infusion (5% to 60%)
+- Normal saline (0.9% Sodium Chloride)
+
+This IV preparataion may be added to parenteral nutrition admixtures containing carbohydrates, lipids, amino acids, electrolytes, and trace elements provided that compatibility and stability have been confirmed.
","Vitamin B6 can reduce the effect of Levodopa. Folic Acid may lower the serum concentration of Phenytoin.
","Known hypersensitivity to any of the components, e.g. Thiamine.
","Allergic reactions may occur in patients hypersensitive to any component of the preparation, e.g. Thiamine.
","Animal reproduction studies or clinical investigations during pregnancy have not been carried out with this preparation. However, there are published reports on safe administration of water-soluble vitamins in this patient group.
","When Lyophilized Powder for Infusion is diluted with water based solutions, the admixture sould be protected from light. This is not necessary if lyophilized powder for infusion is diluted with intralipid because of the protective effect of the fat emulsion.
",,"No adverse effects of an overdose of water-soluble multivitamin have been reported, with exception of cases of extremely high parenteral doses. The possibility of hypervitaminosis A and D should be considered if lyophilized powder for infusion is dissolved in another multivitamin injection.
",,,"Before reconstitution: Store at below 25°C in a dry place, protected from light. Keep out of reach of children. After reconstitution: The reconstituted this IV preparation should be added to the infusion solution aseptically immediately before the start of the infusion & used within 24 hours.
",12
+1198,Multivitamin & Multimineral Essentials [For nursing mother],multivitamin-multimineral-essentials-for-nursing-mother-1198,,Multi-vitamin & Multi-mineral combined preparations,Vitamin deficiency,"For lactating mother to ensure balanced intake of essential vitamins and minerals necessary for child’s development.
","Multi-vitamin & Multi-mineral combined preparations
","This is a special vitamins and minerals preparation comprising of important vitamins and minerals for nursing mother.
","One tablet daily or as directed by a physician. This preparation is indicated for use in improving the nutritional status of mothers throughout lactation period so that the child can get the essential vitamins and minerals for proper growth and development during breast feeding.
",,,"This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
","No clinically significant side effects or toxicity are reported with such kind of preparation.
","Recommended to use in pregnancy and lactation.
","Excess vitamin A intake may be toxic and may increase the risk of birth defects. Women who are (or may become) pregnant are advised not to take this supplement except on the advice of a doctor or antenatal clinic.
",,,,,,8
+779,Multivitamin & Multimineral [For nursing mother],multivitamin-multimineral-for-nursing-mother-779,,Multi-vitamin & Multi-mineral combined preparations,Vitamin deficiency,"This is an advanced formula of 16 essential vitamins & minerals indicated for women while planning conception, throughout pregnancy and when breast feeding. As a complete daily nutritional supplement this is also indicated to meet the increased demands for necessary vitamins and minerals.
","Multi-vitamin & Multi-mineral combined preparations
","This tablet is specially formulated with 16 essential nutrients to provide multivitamin & multimineral support when planning conception, throughout pregnancy and while breast feeding. It is carefully developed by experts so that all ingredients are within safe levels for pregnancy and are moderate rather than excessive. It provides iodine to promote healthy development of baby's brain, eyesight & hearing; provides folic acid that may reduce the risk of brain and/or spinal cord birth defects such as spina bifida if taken daily for 1 month prior to conception and throughout pregnancy. It also provides vitamin D to support calcium absorption to assist with healthy development of baby's bones.
","Two tablets daily with a meal or as prescribed by the physician.
",,,"This product is contraindicated in patients with a known hypersensitivity to any of the ingredients of this preparation.
","Generally well tolerated.
","Recommended to use in pregnancy and lactation.
","If any pregnant woman has a baby with neural tube defect she is advised to consult with her physician. To be dispensed only on the prescription of a registered
physician
",,,,,"Keep in a cool and dry place, protect from light. Keep out of the reach of children.
",9
+786,Multivitamin & Multimineral [A-Z teen girls preparation],multivitamin-multimineral-a-z-teen-girls-preparation-786,,Multi-vitamin & Multi-mineral combined preparations,Vitamin deficiency,"Complete Multivitamin for teen girls to Support: Healthy skin function with Vitamin A, C, Copper & Iron; Healthy immune system with vitamins A, C and E, zinc, iron and selenium; Bone strength with calcium, vitamin D, and magnesium; Energy through the conversion of food to fuel with vitamins B6 and B12, thiamin, riboflavin, and niacin.
","Multi-vitamin & Multi-mineral combined preparations
","This preparation is a comprehensive multivitamin and mineral supplement designed to help teen girls to meet their increased nutritional needs.
","For teen girls, one tablet daily with food.
",,,"This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
","Allergic sensitization has been reported following oral administration of folic acid.
","No data available
","Accidental overdose if an iron-containing product is a leading cause of fatal poisoning in children less than 6 years. Keep this product out of reach of children. In case of accidental overdose, call a doctor immediately. Keep out of reach of children.
",,,,,"Store in cool dry place & away from children.
",9
+785,Multivitamin & Multimineral [A-Z teen boys preparation],multivitamin-multimineral-a-z-teen-boys-preparation-785,,Multi-vitamin & Multi-mineral combined preparations,Vitamin deficiency,"Complete Multivitamin for Teen Boys to Support: Healthy muscle function with magnesium; Healthy immune system with vitamins C and E, beta-carotene, zinc, iron and selenium; Bone strength with calcium, vitamin D, and magnesium; Energy through the conversion of food to fuel with vitamins B6 and B12, thiamin, riboflavin, and niacin.
","Multi-vitamin & Multi-mineral combined preparations
","This preparation is a comprehensive multivitamin and mineral supplement designed to help teen boys to meet their increased nutritional needs.
","Teens: One tablet daily, with food.
",,,"This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
","Allergic sensitization has been reported following oral administration of folic acid.
","No data available
","Folic acid alone is improper therapy in the treatment of pernicious anaemia and other megaloblastic anaemia where Vitamin B12 is deficient.
",,"Accidental overdose if an iron-containing product is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. Do not use this product if safety seal bearing ""Sealed for your protection"" under cap is torn or missing.
",,,"Tablets should be stored below 25˚ C and protected from light & moisture.
",10
+783,Multivitamin & Multimineral [A-Z syrup preparation],multivitamin-multimineral-a-z-syrup-preparation-783,,Multi-vitamin & Multi-mineral combined preparations,Vitamin deficiency,"This Syrup is indicated in multivitamin & multimineral deficiencies in:
+
+- Adults (especially who cannot intake supplements in solid dosage forms e.g. tablet and who suffer gastrointestinal side effects after taking solid dosage forms).
+- Children of all ages & infants.
+
","Multi-vitamin & Multi-mineral combined preparations
","This Syrup is a well balanced supplement containing 24 nutritional elements which include vitamins, minerals & trace elements for the adults & for the all ages of children. This Syrup keeps oneself sharp and physically and mentally active. Stresses and strains of today's life are causing hypertension, diabetes, heart disorders, depression, memory loss and arthritis to the elderly. Some of the declines seniors experience may not be totally age related, but may be caused by poor nutrition, unhealthy eating habits. Research has shown that many times adults fail to get the balanced nutrition that is necessary for proper and healthy bodily functions. As a result, the vital organs of the body begin to break down and illnesses are the result. This Syrup provides optimum nutrition to the senior citizens who cannot intake or tolerate supplements in solid dosage forms like tablet or capsule. Moreover, This Syrup provides the optimal dosage of the essential vitamins and minerals with trace elements for infants and children of all ages. Its essential nutrients support healthy developments, strong immune function and emotional and mental vitality of children. This Syrup contains the primary antioxidant vitamins-C, E & A and minerals - Zn, Se & Mn. All of these elements support immune function, and protect the body from harmful free radicals by neutralizing toxins, helping the body detoxify and eliminating these chemicals; thereby allowing the immune system be more effective and vital on other fonts. The B vitamins are all actively involved helping nervous system functions (learning, memory, managing stress) correctly. Folic acid helps the body digest, assimilate protein and produce RBCs and DNA. Biotin is also involved in DNA/RNA production and fats and oils metabolism which is why it can affect the hair and skin so well. PABA is used to improve the protein used in the body, it relates to red blood cell formation as well as it assists the manufacture of folic acid in the intestines. PABA is an antioxidant nutrient that inhibits the formation of the damaging free radicals. Choline is an essential component of acetylcholine, a neurotransmitter that is involved in regulating sleep, muscle movement, learning and memory.
","For adults: 3-4 teaspoonfuls daily
For children of 4-12 years: 2 - 3 teaspoonfuls daily
For children of 1-4 years: 1-2 teaspoonfuls daily
For infants up to 1 year: 1 teaspoonful daily, or as directed by the physician.
",,"Generally no interactions have been observed.
","The product is contraindicated in patients with a known hypersensitivity to any of the ingredients of this product.
","Generally the product is well tolerated.
","The specific information is not available in this respect.
","Supplement should not be used in over dosage or should not be used long time without the recommendation by a physician.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+782,Multivitamin & Multimineral [A-Z silver preparation],multivitamin-multimineral-a-z-silver-preparation-782,,Multi-vitamin & Multi-mineral combined preparations,Vitamin deficiency,"This is specially formulated for the prevention and treatment of vitamin and mineral deficiencies for adults over 45 years of age. This Silver is also indicated to meet the increase demands of vitamin and minerals for adults over 45 years of age.
","Multi-vitamin & Multi-mineral combined preparations
","This preparation is a comprehensive well-balanced multivitamin and multimineral preparation scientifically adjusted and designed to serve as the complete nutritional program for the elderly people. This preparation maintains a healthy body and active lifestyle and keeps proper nutrition covered for elderly people
","One tablet once daily with food or as indicated by the physician.
",,"No drug interactions have been reported.
","This product is contraindicated in patients with known hypersensitivity to any of the ingredients. Do not take this product if taking other vitamin A supplements.
","Generally, this preparation is well tolerated. Allergic sensitization has been reported following oral administration of folic acid. Vitamin C and vitamin E may cause diarrhea and other gastrointestinal disturbances.
","Recommended by the consultation with physician.
","Long term intake of high levels of vitamin A (excluding that sourced from beta carotene) may increase the risk of osteoporosis in postmenopausal women.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+784,Multivitamin & Multimineral [A-Z juniors syrup preparation],multivitamin-multimineral-a-z-juniors-syrup-preparation-784,,Multi-vitamin & Multi-mineral combined preparations,Vitamin deficiency,"This Syrup is indicated for the treatment and prevention of vitamin and minerals deficiencies.
","Multi-vitamin & Multi-mineral combined preparations
","This syrup contains balanced amounts of all the important vitamins, essential minerals and trace elements. Vitamins are essential substances that are supplied to the body in food. Minerals are indispensable for the metabolism and for growth and regeneration of the body. Finally, trace elements are vital substances which are required by the body in minute quantities but which are not always supplied in the daily food in adequate amounts.
This syrup is used for the prevention and rapid elimination of general vitamin deficiencies. This syrup is used when there is an increased need for vitamins and minerals, particularly during illness, at times of particular exertion and when increased performance is required.
The spectrum of essential nutrients supports healthy development, strong immune function, and emotional and mental vitality. Supplementing a child's diet is the only way to ensure that all nutritional needs are fulfilled.
This syrup provides the optimal dosage of the essential vitamins and minerals with trace elements for infants and children . The great taste makes taking supplements an easy part of a child's daily routine.
","For infants up to 1 year: 1 teaspoon syrup daily
For children 1-4 years: 1-2 teaspoon syrup daily
For children 4-12 years: 2-3 teaspoon syrup daily
For adults: 3-4 teaspoon syrup daily
",,"No such interactions have been reported.
","Contraindicated in patients who are hypersensitive to any of its components.
","This syrup is generally well tolerated.
","Specific information is not available.
","Supplement should not be used in over dosage or continuously except recommended by physicians.
",,,,,"Keep in cool, dry place and away from light.
",10
+1583,Multivitamin & Multimineral [A-Z junior infusion preparation],multivitamin-multimineral-a-z-junior-infusion-preparation-1583,,Multi-vitamin & Multi-mineral combined preparations,Trauma,"This IV is indicated as a daily multivitamin maintenance dosage for infants and children aged up to 11 years receiving parenteral nutrition. It is also indicated in other situations where administration by the intravenous route is required. Such situations include surgery, extensive burns, fractures ... Read more
This IV is indicated as a daily multivitamin maintenance dosage for infants and children aged up to 11 years receiving parenteral nutrition. It is also indicated in other situations where administration by the intravenous route is required. Such situations include surgery, extensive burns, fractures and other trauma, severe infectious diseases and comatose states, which may provoke a stress situation with profound alterations in the body's metabolic demands and consequent tissue depletion of nutrients.
","Multi-vitamin & Multi-mineral combined preparations
","This IV is a sterile, lyophilized powder/cake for infusion which contains nine water-soluble and four fat soluble vitamins. Mixed micelles is used as a solubilizing agent. It is presented as a lyophilized, orange-yellow, sterile powder cake that is to be reconstituted with 5 ml of Water for injections or other parenteral fluids, (e.g. as 0.9% Sodium chloride or 5% Dextrose solution), prior to administration by parenteral route.
","Infants weighing less than 1 kg: The daily dose is 30% (1.5 ml) of a single full dose (5 ml). Do not exceed this daily dose.
Infants weighing 1 to 3 kg: The daily dose is 65% (3.25 ml) of a single full dose (5 ml). A supplemental Vitamin A may be required for low birth weight infants.
Infants and children weighing 3 kg or more up to 11 years of age: The daily dose is 5 ml.
","The single dose vial of This IV is reconstituted by adding 5 ml of sterile Water for injection or other intravenous fluids like 0.9% Sodium Chloride injection or 5% dextrose injection. 5 ml of diluent should be added by means of sterile syringe into the vial and gently mixed to dissolve the lyophilized powder/cake. The product will form a clear and yellow color solution after reconstitution. The reconstituted solution is ready within three minutes for immediate use. After This IV is reconstituted it should be immediately diluted into the intravenous solution. The resulting solution should be administered immediately. Some of the vitamins in this product, particularly vitamins A, D and riboflavin are light-sensitive and exposure to light should be minimized. The reconstituted This IV should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness and possible tissue irritation. For a single dose, 5 ml of reconstituted This IV should be added directly to not less than 100 ml of intravenous dextrose, saline or similar infusion solutions.
","This IV is not physically compatible with alkaline solutions or moderately alkaline drugs such as Acetazolamide, Chlorothiazide sodium, Aminophylline, sodium bicarbonate, Tetracycline HCl. It has also been reported that folic acid is unstable in the presence of calcium salts such as calcium gluconate. Direct addition of This IV to intravenous fat emulsions is not recommended. Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid have been reported to decrease the antibiotic activity of erythromycin, doxycycline and lincomycin. Folic acid may lower the serum concentration of phenytoin resulting in increased seizure frequency. Folic acid may decrease the patient's response to methotrexate therapy.
",,"There have been rare reports of anaphylactic reactions following parenteral multivitamin administration. Rare reports of anaphylactic reactions have also been reported after large intravenous doses of thiamine. The risk is negligible if thiamine is co-administered with other vitamins in the B group. There have been rare reports of the following types of reactions:- rash, erythema, pruritus, headache, dizziness, agitation, anxiety, diplopia, urticaria, shortness of breath, wheezing, and angioedema.
","Not recommended
","Caution should be exercised when administering this multivitamin formulation to patients on warfarin sodium-type anticoagulant therapy as it contains Vitamin K. Larger doses or supplementation with oral or parenteral vitamin E are not recommended because elevated blood levels of vitamin E may result. Additional vitamin A supplementation may be required, especially in low birth weight infants. Polysorbates have been associated with the E-Ferol syndrome (thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension, and metabolic acidosis) in low birth weight infants. This product contains aluminum. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature.
",,"The possibility of hypervitaminosis A or D should be borne in mind. Clinical manifestations of hypervitaminosis A have been reported in patients with renal failure receiving 1.5 mg/day retinol.
",,,"Before reconstitution: Keep in a cool and dry place away from light. After reconstitution: The reconstituted product should be used immediately or it should be stored at 2°C to 8°C for no more than 24 hours. Discard any unused portion of the reconstituted solution.
",11
+781,Multivitamin & Multimineral [A-Z gold preparation],multivitamin-multimineral-a-z-gold-preparation-781,,Multi-vitamin & Multi-mineral combined preparations,Vitamin deficiency,"This is indicated for the prevention and treatment of vitamins & minerals deficiencies. As a complete daily nutritional supplement, it is also indicated to meet the increased demand for vitamins and minerals in the conditions like physical and emotional stress, chronic diseases, infection illness ... Read more
This is indicated for the prevention and treatment of vitamins & minerals deficiencies. As a complete daily nutritional supplement, it is also indicated to meet the increased demand for vitamins and minerals in the conditions like physical and emotional stress, chronic diseases, infection illness, osteoporosis, injuries or wound, surgery, poor digestion, old age, pregnancy and lactation, poor appetite, excess dieting, exposure to environmental pollution, heavy exercise etc.
","Multi-vitamin & Multi-mineral combined preparations
","This is a film coated tablet, which combines 32 high potency vitamins and minerals. This preparation maintains a healthy body and active life-style.
","One tablet daily or as recommended by the physician.
",,"No drug interactions have been reported.
","This product is contraindicated in patients with known hypersensitivity to any of the ingredients.
","Generally, this preparation is well tolerated. Diarrhoea may occasionally occur during treatment with beta carotene and the skin may assume a slightly yellow discoloration. Vitamin C and vitamin E may cause diarrhoea and other gastrointestinal disturbances.
","Recommended by the consultation with physician.
","Long term intake of high level of vitamin A (excluding that sourced from beta carotene) may increase the risk of osteoporosis in postmenopausal women.
",,,,,"Keep in a dry place, away from light and heat. Keep out of the reach of children.
",10
+1203,Multivitamin & Multimineral [A-Z for infanrs & childrens],multivitamin-multimineral-a-z-for-infanrs-childrens-1203,,Multi-vitamin & Multi-mineral combined preparations,Vitamin deficiency,"This preparation is mainly for the malnourished infants of 6 months and children up to 5 years of age to correct anemia, vitamin & mineral deficiency.
","Multi-vitamin & Multi-mineral combined preparations
","This is a special formulation comprisng of 15 necessary vitamins, minerals & trace elements from vitamin A to zinc.
","This multivitamin & multimineral preparation should be given infants & children after completion of 6 months of age upto 5 years, 1 gm sachat to be given daily mixed with usual foods. After mixing the powder, feeding should be completed within half an hour. To correct anemia, vitamin & mineral deficiency 60 sachets should be giver every child within 120 days. At a minimum interval of 6 months 60 sachets can be given repeatedly upto 5 years of age.
",,,"This preparation must not be given in the first 6 months of age. The children severely malnourished or sick and admitted in the hospital also should not be given in the first week of treatment.
","No significant side-effects.
","No data found
","No more than 1 sachet to be given daily. This preparation should not be mixed with too hot (60°C) or too liquid food.
",,,,,,8
+777,Multivitamin & Multimineral,multivitamin-multimineral-777,,Specific mineral & vitamin combined preparations,Vitamin deficiency,"This is indicated for the treatment and/or prevention of vitamin and mineral deficiencies associated with restricted diets, improper food intake, alcoholism and decreased absorption. It is also indicated in patients with increased requirements for vitamins and minerals due to acute and chronic diseases ... Read more
This is indicated for the treatment and/or prevention of vitamin and mineral deficiencies associated with restricted diets, improper food intake, alcoholism and decreased absorption. It is also indicated in patients with increased requirements for vitamins and minerals due to acute and chronic diseases, pregnancy, lactation, menopause, infections, during treatment with antibiotics, convalescence etc. To prevent the occurrence of serious birth defects periconceptional (from three months before conception up to the first trimester of pregnancy) supplementation with this tablet is required.
","Multi-vitamin & Multi-mineral combined preparations, Specific mineral & vitamin combined preparations
","Vitamins and minerals are essential for normal metabolic functions including hematopoiesis. The members of vitamin B-group are components of enzyme system that regulate various stages of carbohydrate, fat and protein metabolism, each of the components playing a specific biological role. Vitamin C is involved in tissue repair and collagen formation. Vitamin A plays an essential role in the function of retina and is essential for growth and differentiation of epithelial tissue. Vitamin E is an antioxidant which preserves essential cellular constituents. Vitamin D is supplemented for prevention and cure of nutritional and metabolic rickets and for treatment of hypoparathyroidism. Iron, Copper, Manganese, Zinc serve as catalysts in enzyme systems which perform vital cellular functions.
","Orally one tablet daily for adult and children over 5 years of age or as directed by the physicians.
",,,"This is contraindicated in patients hypersensitive to any of its components. This is not intended for treatment of severe specific deficiencies of vitamins or minerals. It is not recommended for patients undergoing treatment with levodopa as pyridoxine decreases the efficacy of levodopa. During the first trimester of pregnancy, larger doses of vitamin A (more than 10 tablets per day) may be teratogenic.
","Side effects have been reported with specific vitamins & minerals, but at level substantially higher than those in this tablet. Iron has been associated with gastrointestinal intolerance in some patients.
","During the first trimester of pregnancy, recommended daily dose should not be exceeded. Because larger doses of Vitamin-A (multiple tablets per day) may be teratogenic.
","Not intended for treatment of pernicious anemia or other megaloblastic anemia where vitamin B12 is deficient.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+1130,Multivitamin & Cod Liver Oil,multivitamin-cod-liver-oil-1130,,Specific combined vitamin preparations,Vitamin deficiency,"Multivitamin syrup with cod-liver oil is indicated for growing children-
+
+- It helps in the development and proper functioning of their vital organs.
+- It helps to prevent vitamin deficiency and restore lost vitality after illness, in case of lack of appetite or tiredness of growing children.
... Read more
Multivitamin syrup with cod-liver oil is indicated for growing children-
+
+- It helps in the development and proper functioning of their vital organs.
+- It helps to prevent vitamin deficiency and restore lost vitality after illness, in case of lack of appetite or tiredness of growing children.
+- It also increases immunity and helps to maintain healthy skin, hair, nail, teeth, bone, eye and nervous system.
+- Increases the resistance against cough, cold, chest and bronchial troubles.
+- Helps to optimize brain development.
+- In adults it helps to treat and prevent chronic diseases like heart diseases, rheumatoid arthritis, COPD, cancer etc.
+- In pregnant and nursing mother it helps in proper development of the baby.
+
","Specific combined vitamin preparations
","This preparation contains 8 essential vitamins with Cod Liver Oil. This provides extra protection for the children. It ensures for getting enough vitamins for children that help them to be grown up strong & stay healthy. Cod Liver Oil contains Vitamin A, Vitamin D, EPA & DHA. Vitamin A is essential for the immune system, bone growth, night vision, cellular growth, testicular and ovarian function, Vitamin D is essential for the absorption and utilization of calcium, which is also required for skeletal growth. EPA and DHA; omega-3 fatty acids, which are converted in the body to produce prostaglandins that affect a wide variety of physiological processes due to their modulating effect on the action of hormones. Omega-3 fatty acids relieve the symptoms of osteoarthritis, rheumatoid arthritis which also enhances immune function and promotes healthy blood circulation. It is thought that EPA and DHA may reduce the risk of coronary heart disease. DHA seems essential for normal brain development in unborn babies.
","1-12 Months: 2.5 ml (½ teaspoon) daily
1-4 Years: 5 ml (1 teaspoon) daily
4 years up: 7.5 ml (1½ teaspoon) daily
Adult: 10 ml (2 teaspoons) daily.
This syrup can be taken with water or milk.
",,"Some drug interaction may occur with- Erythromycin, Conjugated estrogens, Sodium bicarbonate, Chloramphenicol etc.
","This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
","Generally well tolerated. However, a few allergic reactions may be seen.
","Should be taken on physician's advice.
","This medicine may accumulate in the body. So, should not be taken in overdose.
",,,,,"Keep in cool and dry place and away from light. Keep away from children
",10
+1661,Multivitamin & 5% Dextrose,multivitamin-5-dextrose-1661,,Multi-vitamin & Multi-mineral combined preparations,General weakness,"This is intended as a supplement for intravenous nutrition in order to meet the daily requirements of the water soluble vitamins of NPO (nothing by mouth) or surgery patients.
","Multi-vitamin & Multi-mineral combined preparations
","This is a sterile, lyophilized powder of water-soluble vitamins for infusion. It contains balanced amount of all the important water soluble vitamins which act as coenzymes of vital enzymes associated with crucial physiological processes, energy metabolism, cell growth and replenishment especially in brain and nerve cells. Vitamin C acts as an antioxidant and helps in collagen formation. Intravenous administration of this combination gives prompt action.
","Adults and children weighing 10 kg or more: 1 vial (10 ml) daily.
Children weighing less than 10 kg: should be given 1 ml of the dissolved mixture per kg body weight/day.
","The contents of one vial are dissolved by the aseptic addition of 10 ml of one of the following:
+
+- Water for injection
+- Fat emulsion 10%
+- Glucose solution for infusion (5% to 60%)
+- Normal saline (0.9% Sodium Chloride)
+
+Vidalin D IV may be added to parenteral nutrition admixtures containing carbohydrates, lipids, amino acids, electrolytes and trace elements provided that compatibility and stability have been confirmed.
","Vitamin B6 can reduce the effect of Levodopa. Folic Acid may lower the serum concentration of Phenytoin.
","Known hypersensitivity to any of the components, e.g. Thiamine.
","Allergic reactions may occur in patients hypersensitive to any component of the preparation, e.g. Thiamine.
","Animal reproduction studies or clinical investigations during pregnancy have not been carried out with this preparation. However, there are published reports on safe administration of water soluble vitamins in this patient group.
","When Lyophilized Powder for Infusion is diluted with water-based solutions, the admixture sould be protected from light. This is not necessary if lyophilized powder for infusion is diluted with intralipid because of the protective effect of the fat emulsion.
",,"No adverse effects of an overdose of water soluble multivitamin have been reported, with exception of cases of extremely high parenteral doses. The possibility of hypervitaminosis A and D should be considered if lyophilized powder for infusion is dissolved in another multivitamin injection.
",,,"Before reconstitution: Store at below 25°C in a dry place, protected from light. Keep out of reach of children. After reconstitution: The reconstituted preparation should be added to the infusion solution aseptically immediately before the start of the infusion & used within 24 hours.
",12
+780,Multivitamin [Pediatric preparation],multivitamin-pediatric-preparation-780,,Specific combined vitamin preparations,Vitamin deficiency,"For prevention and treatment of vitamin deficiency in children and infants.
","Specific combined vitamin preparations
","Vitamin A plays an essential role in the function of retina and is essential for growh and differentiation of epithelial tissue.
Vitamin B: Plays a role in the synthesis and maintenance of coenzyme A. Necessary for lipid metabolism, carbohydrate metabolism, tissue respiration, glycogenolysis, inhibition of very low-density lipoprotein (VLDL) synthesis. May increaase chylomicron triglyceride removal from plasma.
Vitamin B12 (cyanocobalamin): Required for the maintenance of normal erthropoiesis, nucleprotein and myelin synthesis, cell reproduction and normal growth; intrinsic factor, a glycoprotein secreted by the gastric mucosa, is required for active absorption of Vitamin B12 from the Gl tract. Necessary for normal tissue respiration; plays a role in activation of pyridoxine and conversion of tryptophan to niacin.
Vitamin E is an antioxidant which preserves essential cellular constituents.
Vitamin C: Necessary for collagen formation and tissue repair; plays a role in oxidation/reduction reactions as well as other metabolic pathways including synthesis of catecholamines, carnitine, and steroids; also plays a role in conversion of folic acid to folinic acid.
Vitamin D3 is a fat-soluble sterol. It is necessary for the regulation and regulation of calcium and phosphate homoeostasis and bone mineralisation. Vitamin D is also essential for healthy bones as it aids in Calcium absorption from the Gl tract. In addition to this it stimulates bone formation. Clinical studies also show that Calcium and Vitamin D has synergistic effects on bone growth as well as in Osteoporosis and fracture prevention.
","Below 1 year: 9-10 drops (0.3 ml)
1 year and above: 23-25 drops (1.0 ml) once daily or as advised by the physicians.
",,,"Supplemental vitamins should not be prescribed for patients with haemochromatosis or Wilson’s disease. Hypersensitivity to any of the ingredients is contraindicated. Excessive doses of vitamin A and D can lead to hypervitaminosis. When multivitamin preparations are prescribed allowance must be made for vitamins from other sources.
","Multivitamin preparation with ordinary doses of component are usually nontoxic
",,,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",7
+801,Nelfinavir,nelfinavir-801,https://medex.com.bd/attachments/KBVHlYT5Sn330gsaiMLHPNHLh8GS0l/nelfinavir-prescribing-information,Drugs for HIV / Anti-retroviral drugs,HIV infection,"Nelfinavir is indicated for the treatment of HIV infection when antiretroviral therapy is warranted
","Drugs for HIV / Anti-retroviral drugs
","Nelfinavir is a selective, competitive, reversible HIV protease inhibitor. It inhibits HIV-1 protease preventing the cleavage of the gag-pol polyprotein resulting in the production of noninfectious virus.
","Adults: The recommended dose is 1250 mg (five 250 mg tablets) twice daily or 750 mg (three 250 mg tablets) three times daily. Nelfinavir should be taken with a meal. Antiviral activity is enhanced when Nelfinavir is administered in combination with nucleoside analogues. Therefore, it is recommended that Nelfinavir should be used in combination with nucleoside analogues.
Paediatric patients (2-13 years): The recommended oral dose of Nelfinavir for paediatric patients 2 to 13 years of age is 20-30 mg/kg per dose, three times daily with a meal.
",,"Reduced levels/effects with antacids, phenobarbital, carbamazepine, aminoglutethimide, phenytoin, rifampicin, nafcillin, nevirapine, omeprazole, nevirapine. Increased serum levels/effects with azole antifungal agents, cimetidine, efavirenz. Increased serum levels/effects of azithromycin, calcium channel blockers, clarithromycin, corticosteroids (e.g. fluticasone), mirtazapine, nateglinide, nefazodone, ciclosporin, sirolimus, tacrolimus, venlafaxine, eplerinone, fentanyl, atorvastatin, phosphodiesterase-5 (PDE-5) inhibitors, rifabutin, trazodone, TCAs. Reduced serum levels/effects of hormonal contraceptives, methadone, theophylline derivatives.
","Nelfinavir is contraindicated in patients with clinically significant hypersensitivity to any of its components. Co-administration of Avifix is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening adverse events
","The safety of Nelfinavir was studied in over 1500 patients who received drug either alone or in combination with nucleoside analogues. The majority of adverse events were of mild intensity. The most frequently reported adverse event among patients receiving Nelfinavir was diarrhoea, which was generally of mild to moderate intensity. Adverse events occurring in less than 2% of patients receiving Nelfinavir in all phase II/III clinical trials and considered at least possibly related or of unknown relationship to treatment and of at least moderate severity are listed below.
General: Abdominal pain, accidental injury, allergic reaction, asthenia, back pain, fever, headache, malaise, pain and redistribution/accumulation of body fat.
Digestive system: Anorexia, dyspepsia, epigastric pain, gastrointestinal bleeding, hepatitis, mouth ulceration, pancreatitis and vomiting.
Haemic/Lymphatic system: Anaemia, leukopenia and thrombocytopenia.
Metabolic/Nutritional: Increase in alkaline phosphate, amylase, creatinine phosphokinase, lactic dehydrogenase, SGOT, SGPT and g glutamyl transpeptidase, hyperlipaemia, hyperuricaemia, hyperglycaemia, hypoglycaemia, dehydration and liver function tests abnormal.
Musculoskeletal system: Arthralgia, arthritis, cramps, myalgia, myasthenia and myopathy.
Nervous system: Anxiety, depression, dizziness, emotional lability, hyperkinesia, insomnia, migraine, paraesthesia, seizures, sleep disorder, somnolence and suicide ideation.
Respiratory system: Dyspnoea, pharyngitis, rhinitis and sinusitis.
Skin/Appendages: Dermatitis, folliculitis, fungal dermatitis, maculopapular rash, pruitus, sweating, and urticaria.
Ophthalmic: Acute iritis and eye disorder.
Urogenital system: Kidney calculas, sexual dysfunction.
","Pregnancy Category B. There are no adequate and well controlled studies in pregnant women.
Lactation: The US Public Health Service Centers for Disease Control and Prevention advises HIV-infected women not to breast-feed to avoid postnatal transmission of HIV to a child.
","Nelfinavir should not be administered concurrently with Terfenadine, Astemizole, Cisapride, Triazolam, Midazolam, Ergot derivatives, Amiodarone or Quinidine because Nelfinavir may affect the hepatic metabolism of these drugs and create potential for serious and/or life-threatening adverse events. New onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus and hyperglycaemia have been reported during post-marketing surveillance in HIV-infected patients receiving protease inhibitor therapy. Some patients required either initiation or dose adjustments of insulin or oral hypoglycaemic agents for treatment of these events. In some cases diabetic ketoacidosis has occurred. In those patients who discontinued protease inhibitor therapy, hyperglycaemia persisted in some cases.
General: Nelfinavir is principally metabolised by the liver. Therefore, caution should be exercised when administering this drug to patients with hepatic impairment.
Haemophilia: There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthrosis, in patients with haemophilia type A and B treated with protease inhibitors. In some patients, additional factor VIII was given. In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced. A causal relationship has not been established.
","Paediatric use: The safety, effectiveness and pharmacokinetics of Nelfinavir have not been evaluated in paediatric patients below the age of 2 years.
",,,,"Store at 15-30° C
",11
+800,Nefopam Hydrochloride,nefopam-hydrochloride-800,https://medex.com.bd/attachments/LGIaGzEbFPRLs3zPMZpZU6eRqePuFO/nefopam-hydrochloride-prescribing-information,Non opioid analgesics,Pain,"Nefopam Hydrochloride is indicated for the relief of acute pain, including post-operative, dental, musculo-skeletal and acute traumatic pain. It is also indicated in chronic pain like cancer pain.
","Non opioid analgesics, Non-Opioid Analgesics
","Nefopam is a non-opioid analgesic and though it acts centrally, its mechanism is not defined. It also exerts antimuscarinic and sympathomimetic actions.
","Tablet-
+
+- Adults: Dosage may range from 30 to 90 mg three times daily depending on response. The recommended starting dosage is 2 tablets three times daily.
+- Elderly: Elderly patients may require reduced dosage due to slower metabolism. It is strongly recommended that the starting dose does not exceed 1 tablet 3 times daily.
+
+Injection-
+
+- Adult: 20 mg by IM injection, repeated every 6 hours if necessary. It also be given by slow IV injection in similar dose.
+- Children: Not recommended for children under the age of 12 years.
+
",,,"Nefopam Hydrochloride is contraindicated in patients with a history of convulsive disorders and should not be given to patients taking monoamine oxidase (MAO) inhibitors. It is also should not be used in the treatment of myocardial infarction.
","Nefopam Hydrochloride is generally well tolerated. However the most common side-effects are nausea, nervousness, dry mouth, lightheadedness and urinary retention.The less common side-effects are vomiting, blurred vision, drowsiness, sweating, insomnia, headache, confusion, hallucinations, tachycardia and aggravation of angina.
","Pregnancy: Nefopam Hydrochloride is not recommended for pregnant women.
Lactation: Evidence suggests that nefopam is excreted in human milk. A decision should made whether to discontinue nursing or discontinue the medication, taking into account the potential for adverse effects for the foetus and the importance of treatment to the mother.
","Nefopam Hydrochloride should be used with caution in patients with glaucoma and with or at risk of urinary retention. Caution should be exercised when Nefopam is administered concurrently with tricyclic antidepressants. Caution should also be exercised in patients with a history of ischaemic heart disease.
",,"Nefopam toxicity is manifested by neurological symptoms (convulsions, hallucinations, agitation) and cardiovascular response (tachycardia with hyperdynamic circulation). Supportive treatment is suggested including gastric lavage, forced emesis and diuresis. Oral administration of activated charcoal may help prevent absorption. Convulsions and hallucinations may be controlled with diazepam. Beta-adrenergic blockers may be of use in controlling the cardiovascular complications.
",,,,9
+798,Nebivolol Hydrochloride,nebivolol-hydrochloride-798,https://medex.com.bd/attachments/UUtL9hcEqH0XDMcEPvcMOwauaDNh62/nebivolol-hydrochloride-prescribing-information,Beta-adrenoceptor blocking drugs,Hypertension,"Nebivolol is indicated in-
+
+- Hypertension
+- Treatment of essential hypertension
+- Chronic heart failure (CHF)
+- Treatment of stable mild and moderate chronic heart failure in addition to standard therapies in elderly patients.
+
","Beta-adrenoceptor blocking drugs, Beta-blockers
","Nebivolol is a β adrenergic receptor blocking agent. Nebivolol inhibits both β1 and β1 adrenergic receptors. Nebivolol lacks intrinsic sympathomimetic and membrane stabilizing activity at therapeutically relevant concentrations. At clinically relevant doses, Nebivolol does not demonstrate β1-adrenergic receptor blockade activity. Various metabolites, including glucuronides, contribute to beta-blocking activity.
Mode of Action of Nebivolol involved include:
+
+- decreased heart rate
+- decreased myocardia contractility
+- diminution of tonic sympathetic outflow to the periphery from cerebral vasomotor centers
+- suppression of renin activity and
+- vasodilation and decreased peripheral vascular resistance
+
+
Pharmacokinetics: Nebivolol is metabolized by a number of routes, including glucuronidation and hydroxylation by CYP2D6. The active isomer (d-nebivolol) has an effective half-life of about 12 hours in CYP2D6 extensive metabolizers (most people), and 19 hours in poor metabolizers and exposure to d-nebivolol is substantially increased in poor metabolizers. This has less importance than usual, however, because the metabolites, including the hydroxyl metabolite and glucuronides (the predominant circulating metabolites), contribute to b blocking activity.
Absorption and Distribution: Absorption of Nebivolol is similar to an oral solution. Mean peak plasma nebivolol concentrations occur approximately 1.5 to 4 hours post-dosing in EMs and PMs. Food does not alter the pharmacokinetics of nebivolol. Nebivolol may be administered without regard to meals. The in vitro human plasma protein binding of nebivolol is approximately 98%, mostly to albumin, and is independent of nebivolol concentrations.
Metabolism and Excretion: Nebivolol is predominantly metabolized via direct glucuronidation of parent and to a lesser extent via N-dealkylation and oxidation via cytochrome P450 2D6. After a single oral administration of 14C-nebivolol, 38% of the dose was recovered in urine and 44% in feces for EMs and 67% in urine and 13% in feces for PMs.
Digoxin: Concomitant administration of Nebivolol (10 mg once daily) and digoxin (0.25 mg once daily) for 10 days in 14 healthy adult individuals resulted in no significant changes in the pharmacokinetics of digoxin or nebivolol.
Warfarin: Administration of Nebivolol (10 mg once daily for 10 days) led to no significant changes in the pharmacokinetics of nebivolol or R- or S-warfarin following a single 10 mg dose of warfarin. Similarly, nebivolol has no significant effects on the anticoagulant activity of warfarin, as assessed by Prothrombin time and INR profiles from 0 to 144 hours after a single 10 mg warfarin dose in 12 healthy adult volunteers. The starting dose should be reduced in patients with moderate hepatic impairment. No formal studies have been performed in patients with severe hepatic impairment and nebivolol should be contraindicated for these patients.
","The dose of Nebivolol should be individualized to the needs of the patient. For most patients, the recommended starting dose is 5 mg once daily, with or without food, as monotherapy or in combination with other agents. For patients requiring further reduction in blood pressure, the dose can be increased at 2-week intervals up to 40 mg. A more frequent dosing regimen is unlikely to be beneficial.
",,"Nebivolol should be used with care when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide, are used concurrently. Both digitalis glycosides and β-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Nebivolol should not be combined with other β-blockers. Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be closely monitored, because the added β-blocking action of Nebivolol may produce excessive reduction of sympathetic activity. In patients who are receiving Nebivolol and clonidine, Nebivolol should be discontinued for several days before the gradual tapering of clonidine.
CYP2D6 Inhibitors: Use caution when Nebivolol is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.)
","Nebivolol is contraindicated in patients with severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), or severe hepatic impairment (Child-Pugh >B), and in patients who are hypersensitive to any component of this product.
","Headache, nausea and bradycardia.
",,"Abrupt Cessation of Therapy: Patients with coronary artery disease treated with Nebivolol should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported in patients with coronary artery disease following the abrupt discontinuation of therapy with β-blockers. Myocardial infarction and ventricular arrhythmias may occur with or without preceding exacerbation of the angina pectoris. Even patients without overt coronary artery disease should be cautioned against interruption or abrupt discontinuation of therapy. As with other β-blockers, when discontinuation of Nebivolol is planned, patients should be carefully observed and advised to minimize physical activity. Nebivolol should be tapered over 1 to 2 weeks when possible. If the angina worsens or acute coronary insufficiency develops, it is recommended that Nebivolol be promptly reinstituted, at least temporarily.
Cardiac Failure: Sympathetic stimulation is a vital component supporting circulatory function in the setting of congestive heart failure, and (β-blockade may result in further depression of myocardial contractility and precipitate more severe failure. In patients who have compensated congestive heart failure, Nebivolol should be administered cautiously. If heart failure worsens, discontinuation of Nebivolol should be considered.
Angina and Acute Myocardial Infarction: Nebivolol was not studied in patients with angina pectoris or who had a recent Ml.
Bronchospastic Diseases: In general, patients with bronchospastic diseases should not receive (3-blockers.
Anesthesia and Major Surgery: If Nebivolol is to be continued perioperatively, patients should be closely monitored when anesthetic agents which depress myocardial function, such as ether, cyclopropane, and trichloroethylene, are used. If β-blocking therapy is withdrawn prior to major surgery, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. The β-blocking effects of Nebivolol can be reversed by β-agonists, e.g., dobutamine or isoproterenol. However, such patients may be subject to protracted severe hypotension. Additionally, difficulty in restarting and maintaining the heartbeat has been reported with (β-blockers).
Diabetes and Hypoglycemia: β-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia. Nonselective β-blockers may potentiate insulin-induced hypoglycemia and delay recovery of serum glucose levels. It is not known whether nebivolol has these effects. Patients subject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemic agents, should be advised about these possibilities and nebivolol should be used with caution.
Thyrotoxicosis: β-blockers may mask clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of β-blockers may be followed by an exacerbation of the symptoms of hyperthyroidism or may precipitate a thyroid storm.
Peripheral Vascular Disease: β-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Caution should be exercised in these patients.
Non-dihydropyridine Calcium Channel Blockers: Because of significant negative inotropic and chronotropic effects in patients treated with β-blockers and calcium channel blockers of the verapamil and diltiazem type, caution should be used in patients treated concomitantly with these agents and ECG and blood pressure should be monitored.
","Impaired Renal Function: Nebivolol should be used with caution in patients with severe renal impairment because of decreased renal clearance. Nebivolol has not been studied in patients receiving dialysis.
Impaired Hepatic Function: Nebivolol should be used with caution in patients with moderate hepatic impairment because of decreased metabolism. Since Nebivolol has not been studied in patients with severe hepatic impairment, Nebivolol is contraindicated in this population.
Risk of Anaphylactic Reactions: While taking β-blockers, patients with a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated challenges either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+1448,Nebivolol + Hydrochlorothiazide,nebivolol-hydrochlorothiazide-1448,https://medex.com.bd/attachments/YKuCeRiRrJ7AEvNUeytyM45Bafa0qp/nebivolol-hydrochlorothiazide-prescribing-information,Combined antihypertensive preparations,Essential hypertension,"Essential hypertension
","Combined antihypertensive preparations
","The Combination of these ingredients has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone. This combination has mild vasodilating properties which reduces heart rate and blood pressure in hypertensive patients. Hydrochlorothiazide affects the renal tubular mechanisms of electrolyte reabsorption which directly increase the excretion of sodium and chloride in approximately equivalent amounts. The diuretic action of Hydrochlorothiazide reduces plasma volume, increases plasma renin activity and increases aldosterone secretion.
","Once daily, preferably at the same time every day.
",,"Nebivolol:
+
+- Class I & III Antiarrhythmics, Calcium channel blocker (Verapamil/Diltiazem)
+- Centrally-acting antihypertensives, Anaesthetics
+- Antipsychotics, Antidepressants, NSAIDs
+
+Hydrochlorothiazide:
+
+- Drugs affecting Potassium & Calcium level
+- Non-steroidal anti-inflammatory drugs (NSAIDs)
+- Concomitant administration of this combination with Antipsychotics, Tricyclic Antidepressants & Barbiturates may enhance the hypotensive effect and lead to postural hypotension.
+
","Hypersensitivity to the active substances, Liver function impairment. Severe renal insufficiency (Creatinine clearance < 30 ml/min.), Bradycardia, Hypotension
","Nebivolol: Headache, Dizziness, Tiredness, Diarrhoea, Constipation, Nausea etc.
Hydrochlorothiazide: Vertigo, Itchiness, Rash, Increased sensitivity of skin to sunlight etc.
","This combination is not recommended during pregnancy. It is also not recommended for mothers who are breast-feeding
","Nebivolol: Beta-blockers should not be used in patients with untreated Congestive Heart Failure (CHF) & bradycardia. In patients with Chronic Obstructive Pulmonary Diseases (COPD), beta-blockers should be used with caution as airway constriction may be aggravated.
Hydrochlorothiazide: In patients with renal disease, thiazides may increase azotaemia. If progressive renal impairment becomes evident, careful reappraisal of therapy is necessary. Thiazides can cause fluid or electrolyte imbalance. Thiazides may decrease urinary calcium excretion and may cause slight elevation of serum calcium in the absence of known disorders of calcium metabolism
","Use in children is not recommended.
","No data are available on Overdosage. Overdosage with Hydrochlorothiazide is associated with electrolyte depletion and dehydration resulting from excessive diuresis.
",,,"Protect from light & moisture. Store below 30° C. Keep out of reach of children.
",12
+797,Nateglinide,nateglinide-797,https://medex.com.bd/attachments/Z4bbZtSDlw7UrsogmCO3H8QMwaoMgf/nateglinide-prescribing-information,Meglitinide Analogues,Type 2 DM,"Nateglinide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
","Meglitinide Analogues
","Nateglinide, a nonsulfonylurea hypoglycaemic agent which stimulates insulin release from the pancreatic β-cells by blocking ATP-dependent K channels, depolarising the membrane and facilitating Ca entry through Ca channels. This action depends on the amount of existing glucose levels.
","Initial dose: 120 mg orally 3 times a day before meals
Maintenance dose: 60 to 120 mg orally 3 times a day before meals
For patients who are near goal HbA1c when therapy is initiated, therapy should be initiated at 60 mg orally 3 times. May be used as monotherapy, or in combination with metformin or a thiazolidinedione. As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
","Take orally 1 to 30 minutes before a meal. Patients who skip a meal should be instructed to skip the dose for that meal
","CYP2C9 and CYP3A4 inhibitors or inducers may alter metabolism of nateglinide. Increased hypoglycaemic effects with MAOIs, nonselective β-adrenergic blockers, NSAIDs, salicylates. Decreased hypoglycaemic effects with corticosteroids, sympathomimetic agents, thiazide diuretics, thyroid hormones.
","IDDM, diabetic ketoacidosis.
","Hypoglycaemia, upper respiratory tract infection, back pain, flu-like symptoms, dizziness, arthropathy, diarrhoea, accidental trauma, bronchitis, cough.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Patient with adrenal and/or pituitary impairment. Severe renal and moderate to severe hepatic impairment. Pregnancy and lactation.
","Renal Dose Adjustments: No adjustment recommended
Mild hepatic impairment: No adjustment recommended
Moderate to severe hepatic impairment: Use caution
Elderly: No adjustment recommended; however, some individuals may have a greater sensitivity to therapy. Insulin therapy may be temporarily needed in times of fever, infection, trauma, or surgery.
Younger than 18 years: Safety and efficacy have not been established in patients younger than 18 years.
","Symptoms: Hypoglycaemia.
Management: Use IV glucose in severe reaction.
",,,"Store at 25° C.
",13
+796,Natamycin,natamycin-796,https://medex.com.bd/attachments/DjpZGsDAZlNEw1Uk3lLwMdqFT1Fjzn/natamycin-prescribing-information,Ophthalmic antibacterial drugs,Keratitis,"Natamycin sterile ophthalmic suspension is indicated for the treatment of fungal blepharitis, conjunctivitis and keratitis caused by susceptible organisms including Fusarium solani.
","Ophthalmic antibacterial drugs
","Natamycin is a tetraene polyene antibiotic derived from Streptomyces natalensis. Natamycin probably exerts its antifungal effects by binding to sterols in the fungal cell membrane to produce a change in membrane permeability that allows loss of essential cellular constituents. It possesses in vitro activity against a variety of yeast and filamentous fungi, including Candida, Aspergillus, Cephalosporium, Fusarium and Penicillium. Although the activity against fungi is dose-related, Natamycin is predominantly fungicidal. Topical administration appears to produce effective concentration of Natamycin within the corneal stroma but not in intraocular fluid.
","For fungal keratitis: The preferred initial dosage is 1 drop instilled in the conjuntival sac (s) at 1-2 hours interval. The frequency of application can usually be reduced to 1 drop 6-8 times daily after the first 3-4 days. Therapy should generally be continued for 14 to 21 days or until there is resolution of active fungal keratitis. In many cases, it may be helpful to reduce the dosage gradually at 4 to 7 days intervals to assure the replicating fungus has been eliminated.
For fungal blepharitis & conjunctivitis: Less frequent initial dosage, 1 drop 4-6 times daily may be sufficient.
",,"May increase spread of fungal eye infection when used with topical corticosteroid.
","Natamycin ophthalmic suspension is contraindicated in individuals with a history of hypersensitivity to any of its component.
","Eye irritation, eye discomfort, eye edema, conjunctival chemosis and hyperemia has been reported.
","Pregnancy Category C. Natamycin sterile ophthalmic suspension should be given to a pregnant woman only if clearly needed.
Lactation: It is not known whether this drug is excreted in human milk. Caution should be exercised when Natamycin is administered to a nursing mother.
","For topical eye use only. Failure of improvement of keratitis following 7-10 days of administration of the drug suggests that the infection may be caused by a microorganism not susceptible to natamycin.
","Pediatric: Safety and effectiveness in paediatric patients have not been established.
",,,,"Store in a cool and dry place. Protect from light. Do not freeze. Do not use for longer than one month after first opening of the bottle.
",11
+432,Naproxen Sodium + Esomeprazole Magnesium,naproxen-sodium-esomeprazole-magnesium-432,https://medex.com.bd/attachments/tbOeCfUJ2RaGH9bePzpeRnXtJSR0I5/naproxen-sodium-esomeprazole-magnesium-prescribing-information,Drugs for Osteoarthritis,Systemic lupus erythematosus (SLE),"Naproxen & Esomeprazole is indicated for the relief of signs & symptoms of-
+
+- Osteoarthritis
+- Rheumatoid arthritis
+- Ankylosing spondylitis &
+- To decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.
+
","Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","This consists of an immediate release Esomeprazole Magnesium layer & an enteric-coated Naproxen core. As a result, Esomeprazole is released first into the stomach, prior to the dissolution of Naproxen in the small intestine.
Naproxen is a NSAID with analgesic & antipyretic properties. The mechanism of action of Naproxen is to inhibit the prostaglandin synthesis. Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/k+ -ATPase in the gastric parietal cell by acting specifically on the proton pump, Esomeprazole blocks the final step in acid production, thus reducing gastric acidity.
","Carefully consider the potential benefits & risks of this tablet & other treatment options before deciding to use this tablet. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. If a dose of Esomeprazole lower than a total daily dose of 40 mg is more appropriate, a different treatment should be considered.
Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis-
+
+- Adults: One tablet twice daily of either: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole
+
+Juvenile Idiopathic Arthritis in Adolescent Patients 12 Years of Age & Older-
+
+- Weight greater than 50 kg: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole
+- Weight 38 kg to less than 50 kg: One tablet twice daily of 375 mg naproxen/20 mg of esomeprazole.
+
","Do not split, chew, crush or dissolve the tablet. This tablet is to be taken at least 30 minutes before meals.
","With medicine:
+
+- Concomitant use of NSAIDs may reduce the antihypertensive effect of ACE inhibitors, diuretics & beta-blockers
+- Concomitant use of this tablet and warfarin may result in an increased risk of a bleeding complication.
+- Esomeprazole inhibits gastric acid secretion & may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg. Ketoconazole, iron salts and digoxin).
+
+With food & others: Administration of Naproxen & Esomeprazole together with high-fat food in healthy volunteers does not affect the extent of absorption of naproxen but significantly prolongs t
max by 10 hours and decreases peak plasma concentration (C
max) by about 12%
","
+- Known hypersensitivity to any component of this tablet or substituted benzimidazoles.
+- History of asthmay urticaria or other allergic-type reactions after taking aspirin or other NSAIDs.
+- Use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery.
+
","In general, this preparation is well tolerated. The most common adverse reactions in clinical trials (>5%): erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, nausea etc.
","Pregnancy category C. In late pregnancy, it should be avoided because it may cause premature closure of the ductus arteriosus. This tablet should not be used in nursing mothers due to the Naproxen component.
","Patients with known CV disease/risk factors may be at greater risk. This tablet should be used with caution in patients with fluid retention or heart failure.
","Elderly patients: Studies indicate that although the total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Use caution when high doses are required & some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly use the lowest effective dose.
Patients with Moderate to Severe Renal impairment: Naproxen-containing products are not recommended for use in patients with moderate to severe or severe renal impairment (creatinine clearance <30 ml/min).
Hepatic insufficiency: Monitor patients with mild to moderate hepatic impairment closely & consider a possible dose reduction based on the Naproxen component of this tablet. This is not recommended in patients with severe hepatic impairment because Esomeprazole dosage should not exceed 20 mg daily in these patients.
","There is no clinical data on overdosage with this tablet.
Overdose of Naproxen: Significant naproxen overdosage may be characterized by lethargy, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alteration in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, vomiting etc.
Overdose of Esomeprazole: The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor and intermittent clonic convulsions etc.
",,,"Store at temperature of below 30°C, protect from light & moisture. Keep out of reach of children.
",13
+795,Naproxen Sodium,naproxen-sodium-795,https://medex.com.bd/attachments/JEI2zspD3xKjqyxOqxMiCtcvXDlLOT/naproxen-sodium-controlled-release-tablet-prescribing-information,Drugs for Osteoarthritis,Systemic lupus erythematosus (SLE),"Naproxen is indicated for the relief of sign and symptoms of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, juvenile arthritis, tendonitis, bursitis & acute gout. It is also indicated for the management of primary dysmenorrhea & pain.
","Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Naproxen is a non steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic & antipyretic properties. It is rapidly absorbed from the gastrointestinal tract and achieves 95% bioavailability.
","Naproxen Tablet-
+
+- Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis: The usual dose is 500-1000 mg daily in two divided doses after meals.
+- Management of pain, primary dysmenorrhea, acute tendonitis & bursitis: Recommended starting dose is 500 mg followed by 500 mg every 12 hours or 250 mg every 6-8 hours. The initial total daily dose should not exceed 1250 mg and thereafter, the total daily dose should not exceed 1000 mg.
+- Acute gout: Recommended starting dose is 750 mg followed by 250 mg every 8 hours until the attack has subsided.
+
+Naproxen Suspension-
+
+- For Juvenile rheumatoid arthritis: The usual dose for children over 2 years is 10 mg/kg/day given as two divided doses at 12-hours intervals. Therapy in children under 2 years of age is not recommended.
+
+Naproxen Gel-
+
+- Is to be applied 2-6 times a day as required and is not recommended for use in children.
+
",,"ACE inhibitors: diminish the antihypertensive effect of ACE inhibitors.
Antacids & Sucralfate: delay the absorption of Naproxen.
Aspirin: increase adverse effects.
Diuretics: reduce the natriuretic effect of Furosemide and Thiazides.
Methotrexate: enhance the toxicity of Methotrexate.
Warfarin: increase the risk of GI bleeding.
Selective Serotonin Reuptake Inhibitors (SSRI): increase the risk of GI bleeding.
","Naproxen is contraindicated in patients with known hypersensitivity to Naproxen. It should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. It is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
","Most frequently reported side effects include following:
+
+- Gastrointestinal: Heartburn, abdominal pain, nausea, diarrhea, dyspepsia.
+- Central Nervous System: Headache, vertigo, drowsiness.
+- Dermatological: Pruritus (itching), purpura.
+- Cardiovascular: Edema, palpitation.
+- Others: Visual disturbances, hearing disturbances.
+
","US FDA pregnancy category of Naproxen is C. So, Naproxen should be avoided in pregnancy & lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
",,,,,,"Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.
",9
+794,Naphazoline + Zinc Sulfate,naphazoline-zinc-sulfate-794,,Ophthalmic Non-Steroid drugs,Viral conjunctivitis,"Acute and chronic non-infectious conjunctivitis, nonspecific conjunctival irritation; also after successful treatment of bacterial and viral conjunctivitis. Irrigation of the tear ducts.
","Ophthalmic Non-Steroid drugs
","Zinc ions, the active compound of zinc sulphate, have an astringent, i.e. tissue-sealing and slightly anti-septic effect. Naphazoline constricts the blood vessels and reduces the inflammation and swelling of the conjunctiva. This effect of naphazoline, a substance of the benzylimidazoline group, is due to direct binding to a-adrenergic receptor sites on unstriated muscle cells in the blood vessels.
","Adults: 1 drop in the conjunctival sac, three to 4 times per day.
Children: Naphazoline nitrate and Zinc sulphate drops has not been studied in children. Generally, in children the dosage of vasoconstrictors should be low and selected with caution.
",,"Naphazoline containing products should not be administered during treatment with MAO-blockers nor during 10 days after discontinuation of such treatment. The effects of Naphazoline may be increased by concomitant use of tricyclic antidepressants.
","Hypersensitivity to zinc sulphate, Naphazoline and other ingredients. Naphazoline & Zinc is contraindicated in patients suffering from narrow-angle glaucoma, dry eye and especially keratoconjunctivits sicca Sjogren's syndrome. Naphazoline & Zinc must not be used in infants.
","Mydriasis and a slight increase of intraocular pressure in isolated cases. A slight and transient burning sensation may occur after instillation, which does not affect the success of the treatment. Long term use may result in reactive redness of the eye (rebound effect).
In very rare cases systemic cardiovascular effects, such as hypertension and arrhythmia, may occur. Nonspecific fatigue has been observed in some patients.
","Use in pregnancy: There are neither controlled animal studies nor studies in pregnant women available.
Use in lactation: The effects of Naphazoline & Zinc treatment during lactation have not been investigated.
","Uncontrolled use of Naphazoline & Zinc over extended periods of time should be avoided. If no improvement is seen after 2 days, treatment should be discontinued and other therapeutic measures should be considered. If ocular discomfort or visual disturbance occurs during Naphazoline & Zinc treatment, the therapy must be discontinued. Caution is indicated in patients with predisposition to glaucoma and in patients suffering from hypertension, cardiovascular diseases, pheochromocytoma, aneurysm, hyperglycemia, and hyperthyroidism.
",,,,,,9
+1247,Naphazoline + Pheniramine,naphazoline-pheniramine-1247,https://medex.com.bd/attachments/Pn6O5xWxoe5DIHqyLE8vkdU47LwkRd/naphazoline-pheniramine-prescribing-information,Ophthalmic Non-Steroid Combined preparations,Red eye,"This eye drop is indicated for the symptomatic treatment of allergic conjunctivitis
","Ophthalmic Non-Steroid Combined preparations
","Naphazoline, an imidazoline derivative is a sympathomimetic with α-adrenergic activity. It produces vasoconstriction. When applied topically to mucous membranes, it reduces swelling and congestion. It is often used in combination with pheniramine, an alkylamine derivative antihistamine, in ophthalmic preparations.
","Adults and children 6 years of age and older: instill 1 or 2 drops in affected eye(s) up to 4 times daily.
Children under 6 years: ask a doctor.
",,"Increased pressor effects with maprotiline or TCA. Possibility of severe hypertensive reaction with MAOI.
","Angle closure glaucoma.
","Blurring of vision, mild stinging and/or irritation, mydriasis and increased or decreased intraocular pressure. When used in high doses in elderly, naphazoline may liberate pigment granules from the iris.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Glaucoma, hypertension, CV abnormalities, DM, hyperthyroidism, infection, or injury. Pregnancy and lactation. Avoid in infants and young children <6 yr. Rebound congestion may occur with prolonged use or overuse. Patient to seek medical advice if there is ocular pain, vision changes, worsening of redness or irritation of the eye or symptoms lasts >72 hr. Remove contact lens before use.
",,,,,"Store at room temperature 20 degrees to 25 degrees C. Protect from light. Use before expiration date marked on the carton or bottle.
",10
+1604,Nandrolone Phenylpropionate,nandrolone-phenylpropionate-1604,,Hormone in bone formation by stimulation,Osteoporosis,"Nandrolone Phenylpropionate is indicated-
+
+- As an adjunct to specific therapies and dietary measures in pathologic conditions characterized by a negative nitrogen balance
+- For the palliative treatment of selected cases of disseminated mammary carcinoma in women
+- Osteoporosis.
+
","Anabolic steroid (Androgens), Hormone in bone formation by stimulation
","Nandrolone Phenylpropionate is an injectable anabolic preparation. The pharmacologically active substance is nandrolone. The phenylpropionate ester gives the preparation a duration of action of about one week after injection. Nandrolone is chemically related to the male hormone. Compared to testosterone, it has an enhanced anabolic and a reduced androgenic activity. This has been demonstrated in animal bioassays and explained by receptor binding studies. The low androgenicity of nandrolone is confirmed in clinical use.
In the human, Nandrolone Phenylpropionate has a nitrogen saving action. This effect on protein metabolism has been established by metabolic studies and is utilized therapeutically in conditions where a protein deficiency exists such as during chronic debilitating diseases and after major surgery and severe trauma. In these conditions, Nandrolone Phenylpropionate serves as a supportive adjunct to specific therapies and dietary measures. In women with disseminated mammary carcinoma, in selected cases Nandrolone Phenylpropionate has been reported to produce objective regressions for many months. Furthermore, Nandrolone Phenylpropionate has been shown to produce relief of bone pain in patients with osteoporosis. The similarly acting nandrolone ester, nandrolone decanoate, has been shown to increase bone mineral content in these patients. Androgenic effects (e.g. virilisation) are relatively uncommon at the recommended dosages. Nandrolone lacks the C17alpha-alkyl group which is associated with the occurrence of liver dysfunction and cholestasis.
","As an adjunct to specific therapies and dietary measures in pathologic conditions characterized by a negative nitrogen balance: Recommended dose is 25-50 mg every week.
For the palliative treatment of selected cases of disseminated mammary carcinoma in women: Recommended dose is 50 mg every week.
Osteoporosis: Recommended dose is 50 mg every week.
For an optimal therapeutic effect it is necessary to administer adequate amounts of vitamins, minerals and protein in a calorie-rich diet. Nandrolone Phenylpropionate should be administered by deep intramuscular injection.
",,"Anabolic steroids may improve glucose tolerance and decrease the need for insulin or other antidiabetic medicines in diabetics.
","Contraindicated in Pregnancy, Known or suspected carcinoma of the prostate or breast in the male.
","High dosages, prolonged treatment and/or too frequent administration may cause:
+
+- Virilisation which appears in sensitive women as hoarseness, acne hirsutism and increase of libido; in prepubertal boys as an increased frequency of erections and phallic enlargement, and in girls as an increase of pubic hair and clitoral hypertrophy. Hoarseness may be the first symptom of vocal change which may end in a long-lasting, sometimes irreversible deepening of the voice.
+- Amenorrhoea.
+- Inhibition of spermatogenesis.
+- Premature epiphyseal closure.
+- Fluid retention.
+
","This medicine is contraindicated during pregnancy because of possible masculinization of the foetus. There are insufficient data on the use of this medicine during breast-feeding to assess potential harm to the infant or a possible influence on milk production.
","If signs of virilisation develop, discontinuation of the treatment should be considered, Preferably in consultation with the patient.
It is recommended to monitor patients with any of the following conditions:
+
+- latent or overt cardiac failure, renal dysfunction, hypertension or migraine (or a history of these conditions), since anabolic steroids may occasioally induce fluid retention:
+- incomplete statural growth, since anabolic steroids in high dosages may accelerate epiphyseal closure;
+- skeletal metastases of breast carcinoma. In these patients
+- hypercalcaemia may develop both spontaneously and as a result of anabolic steroid therapy. The later can be indicative of a positive tumour response to the hormonal treatment. Nevertheless, the hypercalcaemia should first be treated appropriately and after restoration of normal calcium levels hormone therapy can be resumed;
+- liver dysfunction.
+
+The use of anabolic steroids to enhance athletic ability may carry severe risks to the user's health and should be discouraged.
",,"The acute toxicity of Nandrolone Phenylpropionate in animals is very low. There are no reports of acute overdosage with Nandrolone Phenylpropionate in the human
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+793,Nandrolone Decanoate,nandrolone-decanoate-793,https://medex.com.bd/attachments/hTARH5bVmzMBEDnuqEIBZ3XdSmIePj/nandrolone-decanoate-prescribing-information,Hormone in bone formation by stimulation,Post-menopausal osteoporosis,"Nandrolone Decanoate is indicated in Established Osteoporosis, Disseminated breast cancer in women (palliative therapy), Protein deficiency states occurring after major surgery or trauma, Anemia due to chronic renal failure, Aplastic anemia, Anemia due to cytotoxic therapy, Chronic debilitating disease in elderly, Postsurgical and post traumatic catabolism, During glucocorticosteroid therap.
","Anabolic steroid (Androgens), Hormone in bone formation by stimulation
","Nandrolone Decanoate is an injectable anabolic preparation. The pharmacologically active substance is nandrolone. The decanoate ester gives the preparation duration of action of about three weeks after injection. Nandrolone Decanoate is chemically related to the male hormone. Compared to testosterone, it has an enhanced anabolic and a reduced androgenic activity. This has been demonstrated in animal bioassays and explained by receptor binding studies. The low androgenicity of nandrolone Decanoate is confirmed in clinical use.
In the human, Nandrolone has been shown to positively influence calcium metabolism and to increase bone mass in osteoporosis. In women with disseminated mammary carcinoma Nandrolone Decanoate has been reported to produce objective regressions for many months. Furthermore, Nandrolone Decanoate has a nitrogen-saving action. This effect on protein metabolism has been established by metabolic studies and is utilized therapeutically in conditions where a protein deficiency exists such as during chronic debilitating diseases and after major surgery and severe trauma. In these conditions, Nandrolone Decanoate serves as a supportive adjunct to specific therapies and dietary measures as well as parenteral nutrition.
Androgenic effects (e.g. virilisation) are relatively uncommon at the recommended dosages. Nandrolone Decanoate lacks the C 17 alpha-alkyl group which is associated with the occurrence of liver dysfunction and cholestasis.
","
+- Established Osteoporosis: 50 mg every 3 weeks
+- Disseminated breast cancer in women (palliative therapy): 50 mg every 3 weeks
+- Protein deficiency states occurring after major surgery or trauma: 50 mg every 2-3 weeks
+- Anemia due to chronic renal failure: 50-200 mg per week
+- Aplastic anemia: 50-150 mg per week
+- Anemia due to cytotoxic therapy: 200 mg per week
+- Chronic debilitating disease in elderly: 100 mg
+- Postsurgical and post-traumatic catabolism: 25-50 mg every 3 weeks
+- During glucocorticosteroid therapy: 50 mg every 2-3 week
+
","should be administered by deep intramuscular injection. For an optimal therapeutic effect it is necessary to administer adequate amounts of vitamins, minerals and protein in a calorie-rich diet.
","Due to the nature of the drug, side effects cannot be quickly reversed by discontinuing medication. Injectables in general, may cause a local reaction at the injection site. Depending on the dose, frequency and total period of administration of Nandrolone Decanoate the following undesirable effects may occur: Virilism, Hyperlipidaemia, Increased Libido, Hypertension, Dysphonia, Nausea, Abnormal hepatic function, Peliosis hepatis, Acne, Rash, Pruritus, Hirsutism, Premature fusion of Epiphyses, Decreased urine flow, Benign prostatic hyperplasia, Priapism, Enlarged penis, clitoris, Amenorrhoea, Oligomenorrhoea, Decreased sperm count, Oedema, Injection site reaction, Decreased HDL, increased Haemoglobin.
","Contraindicated in Pregnancy, Male breast carcinoma, Prostatic carcinoma, The patients allergic to peanuts & soya and hypersensitive to the active substance or to any of the excipients including arachis oil.
",,"This medicine is contraindicated during pregnancy because of possible masculinization of foetus. There are insufficient data on the use of this medicine in pregnant women, during breast feeding to assess potential harm to the infant or a possible influence on milk production.
","If signs of virilisation develop, discontinuation of the treatment should be considered, preferably in consultation with the patient.
It is recommended to monitor patients with any of the following conditions:
+
+- latent or overt cardiac failure, renal dysfunction, hypertension of migraine (or a history of these conditions), since anabolic steroids may occasionally induce fluid retention
+- incomplete statural growth, since anabolic steroids in high dosages may accelerate epiphyseal closure skeletal metastases of breast carcinoma. In these patients
+- hypercalcaemia may develop both spontaneously and as a result of anabolic steroid therapy. The later can be indicative of a positive tumour response to the hormonal treatment. Nevertheless, the hypercalcaemia should first be treated appropriately and after restoration of normal calcium levels hormone therapy can be resumed
+- liver dysfunction
+
+The use of anabolic steroids to enhance athletic ability may carry severe risks to the user's health and should be discouraged
",,"The acute toxicity of Nandrolone Decanoate in animals is very low. There are no reports of acute over dosage with Nandrolone Decanoate in the human.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+792,Naltrexone,naltrexone-792,https://medex.com.bd/attachments/OKBHb3qV4mrqBx88emq4erJrXiK4fc/naltrexone-prescribing-information,Antidote preparations,Opioid dependence,"Naltrexone is indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone has not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.
","Antidote preparations
","Naltrexone acts as a competitive antagonist at opioid receptor sites. It blocks the action of opioids and precipitates withdrawal symptoms in opioid-dependent individuals.
","Opioid dependence:
+
+- Initially: 25 mg; increase to 50 mg daily if no withdrawal signs occur.
+- Maintenance: 350 mg wkly given as 50 mg daily or divided in 3 doses (given on 3 days of the wk) for improved compliance.
+
+Adjunct in alcohol dependence: 50 mg daily.
","May be taken with or without food.
","May reduce effects of opiate-containing preparations e.g. those used for cough and cold, diarrhoea and pain. Increased or decreased serum levels with drugs that alter hepatic metabolism. Potentially increased hepatotoxic effects with disulfiram. Increased risk of naltrexone-induced lethargy and somnolence with thioridazine. May increase insulin requirements.
","Patients concurrently dependent on opioids; acute hepatitis or hepatic failure; acute opioid withdrawal; patients on therapeutic opioid analgesics.
","Abdominal pain, nausea, vomiting; anxiety, insomnia, lethargy, headache, musculoskeletal pain; anorexia, diarrhoea, constipation; increased thirst; chest pain; chills, dizziness; sexual dysfunction; rash, liver function abnormalities and reversible idiopathic thrombocytopenia. Inj-site reactions.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Hepatic or renal impairment. Monitor LFTs regularly. Patients should be opioid-free for at least 7-10 days prior to initiating naltrexone therapy. Strictly warn patients against the use of opioids while on naltrexone. Monitor for inj-site reactions. Pregnancy, lactation. History of bleeding disorders (including thrombocytopenia).
",,"Symptoms: Clonic-tonic convulsions and respiratory failure.
Management: Supportive and symptomatic.
",,,"Store at 20-25° C.
",12
+1267,Naloxone Hydrochloride,naloxone-hydrochloride-1267,https://medex.com.bd/attachments/ImbY5NN1CMRwJiMYYU4Qhwyh80BAJH/naloxone-hydrochloride-prescribing-information,Antidote preparations,Opioid dependence,"Naloxone is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids, including propoxyphene, methadone and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and ... Read more
Naloxone is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids, including propoxyphene, methadone and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. Naloxone is also indicated for diagnosis of suspected or known acute opioid overdosage. Naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock
","Antidote preparations
","Naloxone is a pure opioid antagonist that acts competitively at opioid receptors. While the mechanism of action of naloxone is not fully understood, the preponderance of evidence suggests that naloxone antagonizes the opioid effects by competing for the same receptor sites, especially the opioid mu receptor. Recently, naloxone has been shown to bind all three opioid receptors (mu, kappa and gamma) but the strongest binding is to the mu receptor.
","Reversal of central depression from opioid use during surgery:
+
+- Adult: 100-200 mcg at intervals of 2-3 minute, titrate dose according to response while maintaining analgesia.
+- Child: 5-10 mcg IV at 2-3 min intervals.
+
+Opioid overdosage:
+
+- Adult: 0.4-2 mg repeated if necessary at 2-3 min intervals. If there is no response after a total of 10 mg has been given, consider the possibility of overdosage with other drugs. Reduce dose for opioid-dependent patients: 0.1-0.2 mg. IM/SC routes may be used (at IV doses) if IV admin is not feasible.
+- Child: Initially 10 mcg/kg IV followed by 100 mcg/kg IV if necessary. Alternatively, 0.4-0.8 mg IM or SC, repeated as necessary, if IV admin is not feasible.
+
+
Opioid-induced depression in neonates due to obstetric analgesia:
+
+- Child: 10 mcg/kg IV, IM or SC repeated at 2-3 min intervals if necessary or 60 mcg/kg as a single IM dose.
+
",,"Decreased effect of opioid analgesics.
",,"Occur secondarily to reversal (withdrawal) of narcotic analgesia and sedation. Mental depression, apathy, inability to concentrate, sleepiness, irritability, anorexia, nausea, and vomiting in high oral doses during initial treatment of opiate addiction.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Patients physically dependent on opioids, or who have received large doses of opioids (acute withdrawal syndrome may be precipitated). Pregnancy and lactation.
",,,,"Intravenous:
+
+- Reversal of central depression from opioid: Stable in 0.9% sodium chloride and 5% dextrose inj at 4 mcg/ml for 24 hr.
+- Opioid overdosage: Stable in 0.9% sodium chloride and 5% dextrose ing at 4 mcg/ml for 24 hr.
+
+Parenteral: Stable in 0.9% sodium chloride and 5% dextrose inj at 4 mcg/ml for 24 hr.
","Store at 25° C. Protect from light.
",10
+791,Nalidixic Acid,nalidixic-acid-791,https://medex.com.bd/attachments/P83aBLY0X5tIsdFlizqfRsD6DUXePJ/nalidixic-acid-oral-suspension-prescribing-information,Other Anti-protozoals,Urinary tract infection,"Nalidixic acid is indicated in the treatment of urinary tract infection caused by susceptible Gram-negative organisms, including Proteus species, Klebsiella species, Enterobacter species and Escherichia coli.
","Anti-diarrhoeal Antimicrobial drugs, Other Anti-protozoals, Systemic Urinary Anti- infective
","Nalidixic acid is a synthetic narrow spectrum antibacterial. It is bacteriostatic or bactericidal depending on the concentration. Nalidixic acid appears to act by inhibiting bacterial DNA synthesis, possibly by interfering with DNA polymerization. It is rapidly and completely absorbed from the G.I. Tract. Parent drug and active metabolites are distributed to most tissues specially to the kidney and to the urine. During normal renal function, half-life is 1.1 to 2.5 hours and when renal function is impaired, half-life is up to 21 hours. It is rapidly and almost completely excreted within 24 hours.
","Adult: initially is 1 g every 6 hours for 7 days reducing to 500 mg every 6 hours.
Children: Infants and children 3 month of age and over Initial: Oral 13.75 mg per kg body weight every six hours for one or two weeks. Maintenance: Oral 8.25 mg per kg body weight every six hours or as prescribed by the physician.
",,"Concomitant use of Nalidixic acid with melphalan there have been reports of death froms severe blood containing diarrhoea caused by hemorrhagic ulcerative colitis. Probenecids inhibits tubular secretion of nalidixic acid and may therefore elevate serum concentration, possibly enhancing toxicity. Chlorpromazine and Perphenazine have been shown to potentiate the effect of Nalidixic Acid in vitro.
","Nalidixic acid is contraindicated in the following cases- Infants under 3 months, epilepsy, CNS lesions.
","Gastro-intestinal disturbances including nausea, vomiting, diarrhoea, haemolysis in G6PD deficiency, allergic reaction including urticaria, rashes, fever, arthralgia, eosinophilia, also myalgia, muscle weakness, phototoxicity, jaundice, visual disturbances and convulsions.
","There is the possibility that it may cause cartilage damage and as it is a DNA-gyrase inhibitor there is a possibility of causing DNA damage too. Nalidixic acid is excreted in breast milk and there is a report of hemolytic anaemia in a breast feed child of an azotemic mother.
","Risk-benefit must be considered during the first trimester of pregnancy and during breast feeding, impaired renal or hepatic function.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+790,Nalbuphine,nalbuphine-790,https://medex.com.bd/attachments/UnSdPEtDiIeAZ2vxsAL3FabLYaxd4K/nalbuphine-prescribing-information,Opioid analgesics,Post-operative pain,"Nalbuphine Hydrochloride is indicated for the relief of moderate to severe pain. It is used for relief of moderate to severe pain associated with myocardial infarction (MI). Nalbuphine Hydrochloride can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery.
","Opioid analgesics
","Nalbuphine Hydrochloride is a synthetic potent analgesic. Its analgesic potency is essentially equivalent to that of morphine on a milligram basis. Receptor studies show that Nalbuphine binds to mu, kappa, and delta receptors, but not to sigma receptors. Nalbuphine is primarily a kappa agonist/partial mu antagonist analgesic.
","The usual recommended adult dose is 10 mg for a 70 kg individual, administered subcutaneously, intramuscularly or intravenously; this dose may be repeated every 3 to 6 hours as necessary. Dosage should be adjusted according to the severity of the pain, physical status of the patient, and other medications which the patient may be
receiving.
Moderate to severe pain: by intravenous or intramuscular injection 10-20 mg for 70 kg patient, adjusted as required; child up to 0.3 mg/kg repeated once or twice as necessary.
Preoperative anesthesia: by intravenous or intramuscular injection 0.1-0.2 mg/kg.
Obstetrical analgesia during labor & delivery: by intravenous injection 0.3-1 mg/kg over 10-15 minutes with maintenance doses of 0.25-0.5 mg/kg in single intravenous administration as required.
Intraoperative analgesia: by intravenous injection 0.25-0.5 mg/kg at 30 minutes intervals.
Myocardial infarction: By slow intravenous injection 10-20 mg, repeated after 30 minutes if necessary. Larger dose is required when used as supplement of anesthesia than that required for analgesia.
Children from 18 months to 15 years old: usually 0.2 mg/ kg body-weight, given preferably by intravenous or intramuscular injection. Maintenance doses may be given at intervals of 4 to 6 hours or the dose must be determined by the physician.
",,"No hazardous interactions have been identified with Nalbuphine; however, interactions described with other opioids may be anticipated. Patient receiving a narcotic analgesic, general anesthesia, phenothiazines or other tranquilizers, sedatives, hypnotics, or other CNS depressants (including alcohol) concomitantly with Nalbuphine may exhibit an additive effect.
","Known hypersensitivity to Nalbuphine Hydrochloride.
","Generally Nalbuphine is well tolerated. However few side-effects like sedation, sweating, nausea, vomiting, dizziness, vertigo, dry mouth, headache, respiratory depression, dyspnea and asthma may be seen.
","Pregnancy category B. The placental transfer of Nalbuphine is high and rapid. There are no well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Limited data suggest that Nalbuphine is excreted in maternal milk but only in a small amount (less than 1% of the administered dose) and with a clinically insignificant effect. Caution should be exercised when Nalbuphine is administered to a nursing woman.
","Caution should be taken in the following conditions: impaired respiration, impaired renal or hepatic function, billiary tract surgery, myocardial infarction and hypotension.
",,"Sleepiness & mild dyspnea may occur due to overdose. The immediate intravenous administration of an opiate antagonist such as Naloxone or Nalmefene is a specific antidote. Oxygen, intravenous fluids, vasopressors and other supportive measures should be used as indicated
",,,"Keep it in a cool and dry place, protected from light and moisture.
",11
+1409,Naftifine Hydrochloride,naftifine-hydrochloride-1409,https://medex.com.bd/attachments/PR97M2WhunQLy6hlSD1xkP2rhO9mX9/naftifine-hydrochloride-prescribing-information,Topical Antifungal preparations,Tinea corporis (ringworm),"Naftifine cream is an allylamine antifungal indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum
","Topical Antifungal preparations
","Although the exact mechanism of action against fungi is not known, naftifine appears to interfere with sterol biosynthesis by inhibiting the enzyme squalene 2,3-epoxidase. This inhibition of enzyme activity results in decreased amounts of sterols, especially ergosterol, and a corresponding accumulation of squalene in the cells.
","For topical use only. Naftifine Cream is not for ophthalmic, oral, or intravaginal use. Apply a thin layer of Naftifine Cream once-daily to the affected areas plus a ½ inch margin of healthy surrounding skin for 2 weeks
",,,,"The most common adverse reaction (≥1%) is pruritus.
","Pregnancy Category B. There are no adequate and well-controlled studies of Naftifine Cream in pregnant women. Because animal reproduction studies are not always predictive of human response, Naftifine Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Naftifine Cream is administered to a nursing woman.
","If redness or irritation develops with the use of Naftifine Cream treatment should be discontinued.
","Pediatric Use: The safety and effectiveness of Naftifine Cream have been established in the age group 12-17 with interdigital tinea pedis and tinea cruris. Safety and effectiveness in pediatric patients <12 years of age have not been established.
Geriatric Use: Clinical studies of Naftifine Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
",,,,"Store at 25°C; excursions permitted to 15-30°C
",9
+2034,Naftidrofuryl Oxalate,naftidrofuryl-oxalate-2034,https://medex.com.bd/attachments/Ec0cJiu9PBFcEHT9DSjDx4xMxAkTYT/naftidrofuryl-oxalate-prescribing-information,5-HT Agonists,Leg cramps,"Naftidrofuryl oxalate is used to treat peripheral vascular disorders (blood circulation problems outside the brain and heart). It is used to treat the following symptoms of these disorders:
+
+- Intermittent claudication
+- Cramps in legs at night
+- Severe pain in legs while resting (rest pain)
... Read more
Naftidrofuryl oxalate is used to treat peripheral vascular disorders (blood circulation problems outside the brain and heart). It is used to treat the following symptoms of these disorders:
+
+- Intermittent claudication
+- Cramps in legs at night
+- Severe pain in legs while resting (rest pain)
+- Pale or blue fngers or toes which get worse when it is cold
+- Numbness, tingling or burning feelings in fngers or toes (Raynaud’s syndrome or acrocyanosis)
+- Open sores on the legs or feet (trophic ulcers)
+- Poor circulation caused by diabetes (diabetic arteriopathy)
+- To treat gangrene
+
","5-HT Agonists
","Naftidrofuryl oxalate possesses a 5HT2-blocking activity and counteracts both the vasoconstrictor effect and the effect promoting platelet aggregation due to serotonin. Naftidrofuryl oxalate has a direct effect on intracellular metabolism. Thus it increases ATP level, decreases lactic acid level in ischemic conditions and enhances the cellular oxidative capacity. Also, Naftidrofuryl oxalate is a powerful spasmolytic agent.
","One or two Naftidrofuryl oxalate capsules three times daily during meals for a minimum of three months or at the discretion of the physician.
",,,"Hypersensitivity to the active substance or to any of the excipients. Patients with a history of hyperoxaluria or recurrent calcium-containing kidney stones.
","
+- Gastrointestinal disorders (uncommon): Diarrhoea, nausea, vomiting and epigastric pain.
+- Renal and urinary disorders (very rare): Calcium oxalate kidney stones.
+- Skin and subcutaneous tissue disorders (uncommon): Skin rash.
+- Hepatobiliary disorders (rare): Liver damage.
+
","In the absence of any relevant clinical data, the use of Naftidrofuryl Oxalate is not advisable during pregnancy. In the absence of specific data concerning the excretion of the drug in human milk, Naftidrofuryl Oxalate should not be used by breastfeeding women.
","The administration of Naftidrofuryl Oxalate may modify the composition of the urine, promoting the formation of calcium oxalate kidney stones. The administration of Naftidrofuryl Oxalate without liquid before going to bed may cause local oesophagitis. Therefore, it is essential to always take the capsule with a sufficient amount of water. Cases of liver damage have been reported.
",,"Depression of cardiac conduction and convulsions may occur.
",,,"Store below 25°C. Protect from light & moisture. Keep the medicine out of reach of children.
",10
+1398,Nabumetone,nabumetone-1398,https://medex.com.bd/attachments/sOS2MYKjFNhJBo1X7dw1ZC8fm8H5rJ/nabumetone-prescribing-information,Drugs for Osteoarthritis,Rheumatoid arthritis,"Nabumetone is indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis. Carefully consider the potential benefits and risks of Nabumetone and other treatment options before deciding to use Nabumetone. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals
","Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis
","Nabumetone is a naphthylalkanone. Is is a non-selective prostaglandin G/H synthase (a.k.a. cyclooxygenase or COX) inhibitor that acts on both prostaglandin G/H synthase 1 and 2 (COX-1 and -2). Prostaglandin G/H synthase catalyzes the conversion of arachidonic acid to prostaglandin G2 and prostaglandin G2 to prostaglandin H2. Prostaglandin H2 is the precursor to a number of prostaglandins involved in fever, pain, swelling, inflammation, and platelet aggregation. The parent compound is a prodrug that undergoes hepatic biotransformation to the active compound, 6-methoxy-2-naphthylacetic acid (6MNA). The analgesic, antipyretic and anti-inflammatory effects of NSAIDs occur as a result of decreased prostaglandin synthesis.
The parent compound is a prodrug, which undergoes hepatic biotransformation to the active component, 6-methoxy-2-naphthylacetic acid (6MNA), that is a potent inhibitor of prostaglandin synthesis, most likely through binding to the COX-2 and COX-1 receptors.
","Osteoarthritis and Rheumatoid Arthritis: The recommended starting dose is 1,000 mg taken as a single dose with or without food. Some patients may obtain more symptomatic relief from 1,500 mg to 2,000 mg per day. Nabumetone can be given in either a single or twice-daily dose. Dosages greater than 2,000 mg per day have not been studied. The lowest effective dose should be used for chronic treatment. Patients weighing under 50 kg may be less likely to require dosages beyond 1,000 mg; therefore, after observing the response to initial therapy, the dose should be adjusted to meet individual patients’ requirements.
",,"Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.
","Nabumetone is contraindicated in patients with known hypersensitivity to nabumetone or its excipients. Nabumetone should not be given to patients who have experienced asthma, urticaria, or allergictype reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. Nabumetone is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery
","Gastrointestinal: Diarrhea (14%), dyspepsia (13%), abdominal pain (12%), constipation, flatulence, nausea, positive stool guaiac, dry mouth, gastritis, stomatitis, vomiting.
Central Nervous System: Dizziness, headache, fatigue, increased sweating, insomnia, nervousness, somnolence.
Dermatologic: Pruritus, rash
Special Senses: Tinnitus
Miscellaneous: Edema
","Pregnancy Category C. Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. There are no adequate, well-controlled studies in pregnant women. Nabumetone should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether this drug is excreted in human milk, however 6MNA is excreted in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Nabumetone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Labor and Delivery: In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of Nabumetone on labor and delivery in pregnant women are unknown.
","Nabumetone cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. The pharmacological activity of Nabumetone in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions
","Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).
","Symptoms following acute NSAIDs overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression, and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.
Patients should be managed by symptomatic and supportive care following a NSAIDs overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 g/kg in children), and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
There have been overdoses of up to 25 grams of Nabumetone reported with no long-term sequelae following standard emergency treatment (i.e., activated charcoal, gastric lavage, IV H2-blockers, etc.).
",,,"Store at 25°C; excursions permitted to 15-30°C in well-closed container; dispense in light-resistant container.
",12
+1293,Nab-Paclitaxel [Nanoparticle Albumin-Bound Paclitaxel],nab-paclitaxel-nanoparticle-albumin-bound-paclitaxel-1293,https://medex.com.bd/attachments/QnTh4wNBND0KrRnFqZXOmQAcs5Gt0T/nab-paclitaxel-nanoparticle-albumin-bound-paclitaxel-prescribing-information,Cytotoxic Chemotherapy,Pancreatic cancer,"Metastatic Breast Cancer: Nab-Paclitaxel is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically ... Read more
Metastatic Breast Cancer: Nab-Paclitaxel is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
Non-Small Cell Lung Cancer: Nab-Paclitaxel is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
Adenocarcinoma Of The Pancreas: Nab-Paclitaxel is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.
","Cytotoxic Chemotherapy
","Nab-Paclitaxelis a microtubule inhibitor that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. Paclitaxel induces abnormal arrays or ""bundles"" of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.
","Metastatic Breast Cancer: After failure of combination chemotherapy for metastatic breast cancer or relapse within 6 months of adjuvant chemotherapy, the recommended regimen for Nab-Paclitaxel is 260 mg/m² administered intravenously over 30 minutes every 3 weeks.
Non-Small Cell Lung Cancer: The recommended dose of Nab-Paclitaxel is 100 mg/m² administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Administer carboplatin on Day 1 of each 21 day cycle immediately after Nab-Paclitaxel.
Adenocarcinoma Of The Pancreas: The recommended dose of Nab-Paclitaxel is 125 mg/m² administered as an intravenous infusion over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle. Administer gemcitabine immediately after Nab-Paclitaxel on Days 1, 8 and 15 of each 28-day cycle.
Dosage In Patients With Hepatic Impairment: For patients with mild hepatic impairment (total bilirubin greater than ULN and less than or equal to 1.5 x ULN and aspartate aminotransferase [AST] less than or equal to 10 x ULN), no dose adjustments are required, regardless of indication.
Do not administer Nab-Paclitaxel to patients with metastatic adenocarcinoma of the pancreas who have moderate to severe hepatic impairment. Do not administer Nab-Paclitaxel to patients with total bilirubin greater than 5 x ULN or AST greater than 10 x ULN regardless of indication as these patients have not been studied.
",,"The metabolism of paclitaxel is catalyzed by CYP2C8 and CYP3A4. Caution should be exercised when administering Nab-Paclitaxel concomitantly with medicines known to inhibit (e.g., ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir) or induce (e.g., rifampicin, carbamazepine, phenytoin, efavirenz, and nevirapine) either CYP2C8 or CYP3A4.
","Nab-Paclitaxel should not be used in patients who have baseline neutrophil counts of <1,500 cells/mm³. Patients who experience a severe hypersensitivity reaction to Nab-Paclitaxel should not be rechallenged with the drug.
","The most common adverse reactions ( ≥20%) with single-agent use of Nab-Paclitaxel in metastatic breast cancer are alopecia, neutropenia, sensory neuropathy, abnormal ECG, fatigue/asthenia, myalgia/arthralgia, AST elevation, alkaline phosphatase elevation, anemia, nausea, infections, and diarrhea.
The most common adverse reactions ( ≥20%) of Nab-Paclitaxel in combination with carboplatin for non-small cell lung cancer are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue.
The most common serious adverse reactions of Nab-Paclitaxel in combination with carboplatin for non-small cell lung cancer are anemia (4%) and pneumonia (3%).
The most common adverse reactions resulting in permanent discontinuation of Nab-Paclitaxel are neutropenia (3%), thrombocytopenia (3%), and peripheral neuropathy (1%).
The most common adverse reactions resulting in dose reduction of Nab-Paclitaxel are neutropenia (24%), thrombocytopenia (13%), and anemia (6%).
The most common adverse reactions leading to withholding or delay in Nab-Paclitaxel dosing are neutropenia (41%), thrombocytopenia (30%), and anemia (16%).
","Pregnancy Category D. Nab-Paclitaxel can cause fetal harm when administered to a pregnant woman. Administration of paclitaxel formulated as albumin-bound particles to rats during pregnancy at doses lower than the maximum recommended human dose, based on body surface area, caused embryo-fetal toxicities, including intrauterinemortality, increased resorptions, reduced numbers of live fetuses, and malformations.
There are no adequate and well-controlled studies in pregnant women receiving Nab-Paclitaxel. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant while receiving Nab-Paclitaxel
It is not known whether paclitaxel is excreted in human milk. Paclitaxel and/or its metabolites were excreted into the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
",,"Pediatric Use: The safety and effectiveness of Nab-Paclitaxel in pediatric patients have not been evaluated.
Geriatric Use: Of the 229 patients in the randomized study who received Nab-Paclitaxel for the treatment of metastatic breast cancer, 13% were at least 65 years of age and < 2% were 75 years or older. No toxicities occurred notably more frequently among patients who received Nab-Paclitaxel.
A subsequent pooled analysis was conducted in 981 patients receiving Nab-Paclitaxel monotherapy for metastatic breast cancer, of which 15% were 65 years of age or older and 2% were 75 years of age or older. A higher incidence of epistaxis, diarrhea, dehydration, fatigue and peripheral edema was found in patients 65 years of age or older.
Of the 514 patients in the randomized study who received Nab-Paclitaxel and carboplatin for the first-line treatment of non-small cell lung cancer, 31% were 65 years or older and 3.5% were 75 years or older. Myelosuppression, peripheral neuropathy, and arthralgia were more frequent in patients 65 years or older compared to patients younger than 65 years old. No overall difference in effectiveness, as measured by response rates, was observed between patients 65 years or older compared to patients younger than 65 years old.
Of the 431 patients in the randomized study who received Nab-Paclitaxel and gemcitabine for the first-line treatment of pancreatic adenocarcinoma, 41% were 65 years or older and 10% were 75 years or older. No overall differences in effectiveness were observed between patients who were 65 years of age or older and younger patients. Diarrhea, decreased appetite, dehydration and epistaxis were more frequent in patients 65 years or older compared with patients younger than 65 years old. Clinical studies of Nab-Paclitaxel did not include sufficient number of patients with pancreatic cancer who were 75 years and older to determine whether they respond differently from younger patients.
Patients With Hepatic Impairment: The exposure to paclitaxel may be higher in patients with hepatic impairment than in patients with normal hepatic function. Reduce Nab-Paclitaxel starting dose in patients with moderate to severe hepatic impairment. Do not administer Nab-Paclitaxel to patients with total bilirubin > 5 x ULN or AST> 10 x ULN. Do not administer to patients with metastatic adenocarcinoma of the pancreas who have moderate to severe hepatic impairment.
Patients With Renal Impairment: Adjustment of the starting Nab-Paclitaxel dose is not required for patients with mild to moderate renal impairment (estimated creatinine clearance ≥ 30 to < 90 mL/min). There are insufficient data to permit dosage recommendations in patients with severe renal impairment or end stage renal disease (estimated creatinine clearance < 30 mL/min).
","There is no known antidote for Nab-Paclitaxel overdosage. The primary anticipated complications of overdosage would consist of bone marrow suppression, sensory neurotoxicity, and mucositis.
",,,"Store the vials in original cartons at 20°C to 25°C. Retain in the original package to protect from bright light.
",11
+2027,Nirmatrelvir + Ritonavir,nirmatrelvir-ritonavir-2027,https://medex.com.bd/attachments/anfjHvrfwkObcGDMJJlI71O7uDcOzY/nirmatrelvir-ritonavir-prescribing-information,,,"Indicated for mild-to-moderate COVID-19 positive adult and pediatric patients (12 years of age and older weighing at least 40 kg), who are at high risk for progression to severe COVID-19, including hospitalization or death.
",,"This inhibits the main protease (Mpro) of the SARS-CoV-2. This main protease (Mpro) is also referred as 3C-like protease (3CLpro) or nsp5 protease. This inhibition of Mpro hampers the peptidomimetic activity of SARS-CoV-2. Ritonavir is an HIV-1 protease inhibitor but is not active against SARS-CoV-2 Mpro. Ritonavir inhibits the CYP3A mediated metabolism of Nirmatrelvir, resulting in increased plasma concentrations of Nirmatrelvir
","Nirmatrelvir must be co-administered with Ritonavir. Initiate this treatment as soon as possible after diagnosis of COVID-19 and within 3-5 days of symptom onset. Administer orally with or without food.
Dosage: 300 mg Nirmatrelvir (two 150 mg tablets) with 100 mg Ritonavir (one 100 mg tablet), with all three tablets taken together twice daily for 5 days.
Missed Dose: If the patient misses a dose of this within 8 hours of the time it is usually taken, the patient should take it as soon as possible and resume the normal dosing schedule. If the patient misses a dose by more than 8 hours, the patient should not take the missed dose and instead take the next dose at the regularly scheduled time. The patient should not double the dose to make up for a missed dose.
",,"Co-administration of this tablet with drugs highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated. Co-administration with other CYP3A substrates may require a dose adjustment or additional monitoring. Nirmatrelvir and Ritonavir are CYP3A substrates; therefore, drugs that induce CYP3A may decrease Nirmatrelvir and Ritonavir plasma concentrations and reduce this tablet therapeutic effect.
","
+- History of clinically significant hypersensitivity reactions to the active ingredients (Nirmatrelvir or Ritonavir) or any other components.
+- Co-administration with drugs highly dependent on CYP3A for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions.
+- Co-administration with potent CYP3A inducers where significantly reduced Nirmatrelvir or Ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance.
+
","Adverse events (incidence >1% and subject difference) were dysgeusia, diarrhea, hypertension, and myalgia.
","This is not recommended during pregnancy and in people who can become pregnant and who are not using contraception. Breastfeeding should be interrupted during treatment. These recommendations are because laboratory studies in animals suggest that high doses of this may impact the growth of the fetus. This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk to the fetus; use of oral solution is not recommended.
","The concomitant use of this tablet and certain other drugs may result in potentially significant drug interactions. Consult the full prescribing information prior to and during treatment for potential drug interactions.
Hepatotoxicity: Hepatic transaminase elevations, clinical hepatitis, and jaundice have occurred in patients receiving Ritonavir.
HIV-1 Drug Resistance: This tablet use may lead to a risk of HIV-1 developing resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1 infection.
","Pediatric Use: This tablet is not authorized for use in pediatric patients younger than 12 years of age or weighing less than 40 kg. The safety and effectiveness of this tablet have not been established in pediatric patients.
Geriatric Use: Clinical studies of this tablet include subjects 65 years of age and older and their data contributes to the overall assessment of safety and efficacy.
Renal Impairment: No dosage adjustment is needed in patients with mild renal impairment. In patients with moderate renal impairment (eGFR >30 to <60 mL/min), reduce the dose of This tablet to 150 mg Nirmatrelvir and 100 mg Ritonavir twice daily for 5 days. This tablet is not recommended in patients with severe renal impairment (eGFR <30 mL/min).
Hepatic Impairment: No dosage adjustment of this tablet is needed for patients with either mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. This tablet is not recommended in patients with severe hepatic impairment (Child-Pugh Class C).
","Treatment of an overdose of this tablet should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. There is no specific antidote for overdose with this tablet.
",,,"Do not store above 30°C. Keep in a dry place. Protect from light and keep out of the reach of children.
",11
+1858,Niraparib,niraparib-1858,https://medex.com.bd/attachments/1EDN8Mqkg1FnOxiJNZ45Pu8QgKTULU/niraparib-prescribing-information,Cytotoxic Chemotherapy,Ovarian cancer,"Niraparib is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
","Cytotoxic Chemotherapy
","Niraparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, PARP-1 and PARP-2, which play a role in DNA repair. In vitro studies have shown that niraparib induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, apoptosis and cell death. Increased Niraparib-induced cytotoxicity was observed in tumor cell lines with or without deficiencies in BRCA1/2. Niraparib decreased tumor growth in mouse xenograft models of human cancer cell lines with deficiencies in BRCA1/2 and in human patient-derived xenograft tumor models with homologous recombination deficiency that had either mutated or wild type BRCA1/2.
Absorption: The absolute bioavailability of niraparib is approximately 73%. Following oral administration of Niraparib, peak plasma concentration, Cmax, is reached within 3 hours. Concomitant administration of a high fat meal (800-1,000 calories with approximately 50% of total caloric content of the meal from fat) did not significantly affect the pharmacokinetics of Niraparib.
Distribution: Niraparib is 83.0% bound to human plasma proteins. The average (±SD) apparent volume of distribution (Vd/F) was 1220 (±1114) L. In a population pharmacokinetic analysis, the Vd/F of Niraparib was 1074 L in cancer patients.
Elimination: Following multiple daily doses of 300 mg Niraparib, the mean half-life (t1/2) is 36 hours. In a population pharmacokinetic analysis, the apparent total clearance (CL/F) of niraparib was 16.2 L/h in cancer patients.
Metabolism: Niraparib is metabolized primarily by carboxylesterases (CEs) to form a major inactive metabolite, which subsequently undergoes glucuronidation.
Excretion: Following administration of a single oral 300 mg dose of radio-labeled Niraparib, the average percent recovery of the administered dose over 21 days was 47.5% (range 33.4% to 60.2%) in urine and 38.8% (range 28.3% to 47.0%) in feces. In pooled samples collected over 6 days, unchanged Niraparib accounted for 11% and 19% of the administered dose recovered in urine and feces, respectively
","The recommended dose of Niraparib as monotherapy is 300 mg (three 100 mg capsules) taken orally once daily. Instruct patients to take their dose of Niraparib at approximately the same time each day. Each capsule should be swallowed whole. Niraparib may be taken with or without food. Bedtime administration may be a potential method for managing nausea. Patients should start treatment with Niraparib no later than 8 weeks after their most recent platinum-containing regimen. Niraparib treatment should be continued until disease progression or unacceptable toxicity. In the case of a missed dose of Niraparib, instruct patients to take their next dose at its regularly scheduled time. If a patient vomits or misses a dose of Niraparib, an additional dose should not be taken.
Niraparib is for oral use. The capsules should be swallowed whole with water. The capsules should not be chewed or crushed. Niraparib can be taken without regard to meals.
",,"Inhibition of CYPs (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4). Neither Niraparib nor M1 is an inhibitor of any active ubstance-metabolising CYP enzymes, namely CYP1A1/2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A4/5. Even though inhibition of CYP3A4 in the liver is not expected, the potential to inhibit CYP3A4 at the intestinal level has not been established at relevant Niraparib concentrations. Therefore, caution is recommended when Niraparib is combined with active substances the metabolism of which is CYP3A4-dependent and, notably, those having a narrow therapeutic range (e.g. ciclosporin, tacrolimus, alfentanil, ergotamine, pimozide, quetiapine and halofantrine).
Induction of CYPs (CYP1A2 and CYP3A4): Neither Niraparib nor M1 is a CYP3A4 inducer in vitro. In vitro, Niraparib weakly induces CYP1A2 at high concentrations and the clinical relevance of this effect would not be completely ruled out. M1 is not a CYP1A2 inducer. Therefore, caution is recommended when niraparib is combined with active substances the metabolism of which is CYP1A2-dependent and, notably, those having a narrow therapeutic range (e.g. clozapine, theophylline and ropinirole).
","Hypersensitivity to the active substance or to any of the excipients & breast-feeding.
","In the pivotal ENGOT-OV16 study, adverse reactions (ADRs) occurring > 10% of patients receiving Niraparib monotherapy were nausea, thrombocytopenia, fatigue/asthenia, anaemia, constipation, vomiting, abdominal pain, neutropenia, insomnia, headache, decreased appetite, nasopharyngitis, diarrhoea, dyspnea, hypertension, dyspepsia, back pain, dizziness, cough, urinary tract infection, arthralgia, palpitations, and dysgeusia. The most common serious adverse reactions >1% (treatment-emergent frequencies) were thrombocytopenia and anaemia.
","Women of childbearing potential/contraception in females Women of childbearing potential should not become pregnant while on treatment and should not be pregnant at the beginning of treatment. A pregnancy test should be performed on all women of childbearing potential prior to treatment. Women of childbearing potential must use effective contraception during therapy and for 1 month after receiving the last dose of Niraparib.
Pregnancy: There are no or limited amount of data from the use of Niraparib in pregnant women. Animal reproductive and developmental toxicity studies have not been conducted. However, based on its mechanism of action, niraparib could cause embryonic or foetal harm, including embryo-lethal and teratogenic effects, when administered to a pregnant woman. Niraparib should not be used during pregnancy.
Breast-feeding: It is unknown whether niraparib or its metabolites are excreted in human milk. Breast-feeding is contraindicated during administration of Niraparib and for 1 month after receiving the last dose.
Fertility: There are no clinical data on fertility. A reversible reduction of spermatogenesis was observed in rats and dogs.
","Myelodysplastic syndrome/acute myeloid leukaemia: Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML), including cases with fatal outcome, have been reported in a small number of patients who received Niraparib or placebo. In the pivotal Phase 3 international trial (ENGOT-OV16), the incidence of MDS/AML in patients who received niraparib (1.4%) was similar to that in patients who received placebo (1.1%). Overall, MDS/AML has been reported in 7 out of 751 (0.9%) patients treated with Niraparib in clinical studies. The duration of Niraparib treatment in patients prior to developing MDS/AML varied from 1 month to > 2 years. The cases were typical of secondary, cancer therapy-related MDS/AML. All patients had received multiple platinum-containing chemotherapy regimens and many had also received other DNA damaging agents and radiotherapy. Some of the patients had a history of bone marrow dysplasia. If MDS and/or AML are confirmed while on treatment with Niraparib, treatment should be discontinued and the patient treated appropriately.
Hypertension including hypertensive crisis: Hypertension, including hypertensive crisis, has been reported with the use of Niraparib. Pre-existing hypertension should be adequately controlled before starting Niraparib treatment. Blood pressure should be monitored monthly for the first year and periodically thereafter during treatment with Niraparib. Hypertension should be medically managed with antihypertensive medicinal products as well as adjustment of the Niraparib dose, if necessary. In the clinical programme, blood pressure measurements were obtained on Day 1 of each 28-day cycle while the patient remained on Niraparib. In most cases, hypertension was controlled adequately using standard antihypertensive treatment with or without Niraparib dose adjustment. Niraparib should be discontinued in case of hypertensive crisis or if medically significant hypertension cannot be adequately controlled with antihypertensive therapy.
Pregnancy/contraception: Niraparib should not be used during pregnancy or in women of childbearing potential not willing to use reliable contraception during therapy and for 1 month after receiving the last dose of Niraparib. A pregnancy test should be performed on all women of childbearing potential prior to treatment.
Lactose: Niraparib hard capsules contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption should not take this medicine.
Tartrazine (E102): This medicinal product contains tartrazine (E 102), which may cause allergic reactions.
","Elderly: No dose adjustment is necessary for elderly patients (> 65 years). There are limited clinical data in patients aged 75 or over.
Paediatric population: The safety and efficacy of niraparib in children and adolescents below 18 years of age have not yet been established. No data are available.
Renal impairment: No dose adjustment is necessary for patients with mild to moderate renal impairment. There are no data in patients with severe renal impairment or end-stage renal disease undergoing hemodialysis; use with caution in these patients.
Hepatic impairment: No dose adjustment is needed in patients with mild to moderate hepatic impairment. There are no data in patients with severe hepatic impairment; use with caution in these patients.
","There is no specific treatment in the event of Niraparib overdose, and symptoms of overdose are not established. In the event of an overdose, physicians should follow general supportive measures and should treat symptomatically.
",,,"Store in a cool and dry place. Do not store above 30°C. Do not take Niraparib if it is suspected of having been exposed to temperatures greater than 40°C or 104°F. Keep Niraparib out of the reach and sight of children.
",12
+1644,Nintedanib,nintedanib-1644,https://medex.com.bd/attachments/C8Qa6IoQQMhCrsHxPITb1u3zxejLZr/nintedanib-prescribing-information,Tyrosine Kinase Inhibitor,Idiopathic Pulmonary Fibrosis,"
+- Nintedanib is indicated in adults for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
+- Nintedanib is indicated in adults for the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.
+- Nintedanib is indicated in adults for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD).
... Read more
+- Nintedanib is indicated in adults for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
+- Nintedanib is indicated in adults for the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.
+- Nintedanib is indicated in adults for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD).
+- Nintedanib is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology after first-line chemotherapy.
+
","Tyrosine Kinase Inhibitor
","Nintedanib is a small molecule, competitive, triple angiokinase inhibitor that targets multiple receptor tyrosine kinases (RTKs) and non-receptor tyrosine kinases (nRTKs). Many of these RTKs are implicated in lung fibrosis and tumour angiogenesis, so nintedanib is therefore used in the treatment of proliferative diseases such as idiopathic pulmonary fibrosis, non-small cell lung cancer, and systemic sclerosis-associated interstitial lung disease. The specific RTKs that nintedanib inhibits are platelet-derived growth factor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1-3, vascular endothelial growth factor receptor (VEGFR), and Fns-Like tyrosine kinase-3 (FLT3). Nintedanib binds to the ATP-binding pocket of these receptors and inhibits their activity, thereby blocking signalling cascades that result in the proliferation and migration of lung fibroblasts. Nintedanib also inhibits kinase signalling pathways in various cells within tumour tissues, including endothelial cells, pericytes, smooth muscle cells, and cells contributing to angiogenesis, culminating in an inhibition of cell proliferation and apoptosis of affected tumour cells.
In addition to RTK inhibition, nintedanib also prevents the actions of the nRTKs Lck, Lyn, and Src. The contribution of the inhibition of Lck and Lyn towards the therapeutic efficacy of nintedanib is unclear, but inhibition of the Src pathway by nintedanib has been shown to reduce lung fibrosis.
","Treatment with Nintedanib should be initiated by physicians experienced in the diagnosis and treatment of IPF.
Posology: The recommended dose is 150 mg Nintedanib twice daily administered approximately 12 hours apart. The 100 mg twice daily dose is only recommended to be used in patients who do not tolerate the 150 mg twice daily dose. If a dose is missed, administration should resume at the next scheduled time at the recommended dose. If a dose is missed the patient should not take an additional dose. The recommended maximum daily dose of 300 mg should not be exceeded.
For NSCLC:
+
+- The recommended dose of nintedanib is 200 mg twice daily administered approximately 12 hours apart, on days 2 to 21 of a standard 21 day docetaxel treatment cycle.
+- Nintedanib must not be taken on the same day of docetaxel chemotherapy administration (= day 1). If a dose of nintedanib is missed, administration should resume at the next scheduled time at the recommended dose. The individual daily doses of nintedanib should not be increased beyond the recommended dose to make up for missed doses. The recommended maximum daily dose of 400 mg should not be exceeded.
+- Patients may continue therapy with nintedanib after discontinuation of docetaxel for as long as clinical benefit is observed or until unacceptable toxicity occurs.
+- Dose adjustments: In addition to symptomatic treatment if applicable, the management of adverse reactions to Nintedanib could include dose reduction and temporary interruption until the specific adverse reaction has resolved to levels that allow continuation of therapy. Nintedanib treatment may be resumed at the full dose (150 mg twice daily) or a reduced dose (100 mg twice daily). If a patient does not tolerate 100 mg twice daily, treatment with Nintedanib should be discontinued.
+- In case of interruptions due to aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevations > 3x upper limit of normal (ULN), once transaminases have returned to baseline values, treatment with Nintedanib may be reintroduced at a reduced dose (100 mg twice daily) which subsequently may be increased to the full dose (150 mg twice daily).
+
","Nintedanib is for oral use. The capsules should be taken with food, swallowed whole with water, and should not be chewed or crushed.
","P-glycoprotein (P-gp): Nintedanib is a substrate of P-gp. Co-administration with the potent P-gp inhibitor ketoconazole increased exposure to Nintedanib 1.61-fold based on AUC and 1.83-fold based on Cmax in a dedicated drug-drug interaction study. In a drug-drug interaction study with the potent P-gp inducer rifampicin, exposure to Nintedanib decreased to 50.3% based on AUC and to 60.3% based on Cmax upon co-administration with rifampicin compared to administration of Nintedanib alone. If co-administered with Nintedanib, potent P-gp inhibitors (e.g. ketoconazole, erythromycin or cyclosporine) may increase exposure to Nintedanib. In such cases, patients should be monitored closely for tolerability of Nintedanib. Management of side effects may require interruption, dose reduction, or discontinuation of therapy with Nintedanib. Potent P-gp inducers (e.g. rifampicin, carbamazepine, phenytoin, and St. John’s Wort) may decrease exposure to Nintedanib. Selection of an alternate concomitant medicinal product with no or minimal P-gp induction potential should be considered.
Cytochrome (CYP)-enzymes: Only a minor extent of the biotransformation of Nintedanib consisted of CYP pathways. Nintedanib and its metabolites, the free acid moiety BIBF 1202 and its glucuronide BIBF 1202 glucuronide, did not inhibit or induce CYP enzymes in preclinical studies. The likelihood of drug-drug interactions with Nintedanib based on CYP metabolism is therefore considered to be low.
Co-administration with other medicinal products: The potential for interactions of Nintedanib with hormonal contraceptives was not explored.
","Hypersensitivity to Nintedanib, to peanut or soya, or to any of the excipients.
","Summary of the safety profile: Nintedanib has been studied in clinical trials of 1,529 patients suffering from IPF. The safety data provided in the following are based on the two Phase III, randomized, double-blind, placebo-controlled studies in 1,061 patients comparing treatment with Nintedanib 150 mg twice daily to placebo for 52 weeks (INPULSIS-1 and INPULSIS-2) and based on data observed during the post-marketing period.
The most frequently reported adverse reactions associated with the use of Nintedanib included diarrhea, nausea and vomiting, abdominal pain, decreased appetite, weight decreased and hepatic enzyme increased.
Tabulated list of adverse reactions: The below table provides a summary of the adverse reactions by MedDRA System Organ Class (SOC) and frequency category.
Below table summarizes the frequencies of adverse drug reactions (ADRs) that were reported in the Nintedanib group (638 patients) pooled from the two placebo-controlled Phase III clinical trials of 52 weeks duration or from the post-marketing period.
Frequency categories are defined using the following convention: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
","Women of childbearing potential/Contraception: Nintedanib may cause foetalharm in humans. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Nintedanib. They should be advised to use adequate contraception during and at least 3 months after the last dose of Nintedanib. Since the effect of Nintedanib on the metabolism and efficacy of hormonal contraceptives has not been investigated, barrier methods should be applied as a second form of contraception, to avoid pregnancy.
Pregnancy: There is no information on the use of Nintedanib in pregnant women, but pre-clinical studies in animals have shown reproductive toxicity of this active substance. As Nintedanib may cause foetal harm also in humans, it must not be used during pregnancy. Female patients should be advised to notify their doctor or pharmacist if they become pregnant during therapy with Nintedanib. If the patient becomes pregnant while receiving Nintedanib, she should be apprised of the potential hazard to the foetus. Termination of the treatment with Nintedanib should be considered.
Lactation: There is no information on the excretion of Nintedanib and its metabolites in human milk. Pre-clinical studies showed that small amounts of Nintedanib and its metabolites (≤ 0.5% of the administered dose) were secreted into milk of lactating rats. A risk to the newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with Nintedanib.
Fertility: Based on preclinical investigations there is no evidence for impairment of male fertility. From subchronic and chronic toxicity studies, there is no evidence that female fertility in rats is impaired at a systemic exposure level comparable with that at the maximum recommended human dose (MRHD) of 150 mg twice daily.
","Diarrhoea: In the INPULSIS trials, diarrhoea was the most frequent gastro-intestinal adverse reaction reported in 62.4% versus 18.4% of patients treated with Nintedanib and placebo, respectively. In most patients the adverse reaction was of mild to moderate intensity and occurred within the first 3 months of treatment. Diarrhoea led to dose reduction in 10.7% of the patients and to discontinuation of Nintedanib in 4.4% of the patients in clinical trials. Serious cases of diarrhoea leading to dehydration and electrolyte disturbances have been reported in the post-marketing. Patients should be treated at first signs with adequate hydration and anti-diarrhoeal medicinal products, e.g. loperamide, and may require treatment interruption. Nintedanib treatment may be resumed at a reduced dose (100 mg twice daily) or at the full dose (150 mg twice daily). In case of persisting severe diarrhoea despite symptomatic treatment, therapy with Nintedanib should be discontinued.
Nausea and vomiting: Nausea and vomiting were frequently reported gastrointestinal adverse reactions. In most patients with nausea and vomiting, the event was of mild to moderate intensity. Nausea led to discontinuation of Nintedanib in 2.0% of patients. Vomiting led to discontinuation in 0.8% of the patients. If symptoms persist despite appropriate supportive care (including anti-emetic therapy), dose reduction or treatment interruption may be required. The treatment may be resumed at a reduced dose (100 mg twice daily) or at the full dose (150 mg twice daily). In case of persisting severe symptoms therapy with Nintedanib should be discontinued.
Hepatic function: The safety and efficacy of Nintedanib has not been studied in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Therefore, treatment with Nintedanib is not recommended in such patients. Based on increased exposure, the risk for adverse events may be increased in patients with mild hepatic impairment (Child Pugh A). Patients with mild hepatic impairment (Child Pugh A) should be treated with a reduced dose of Nintedanib. Cases of drug-induced liver injury have been observed with Nintedanib treatment, including severe liver injury with fatal outcome. The majority of hepatic events occur within the first three months of treatment. Therefore, hepatic transaminase and bilirubin levels should be investigated before treatment initiation and during the first month of treatment with Nintedanib. Patients should then be monitored at regular intervals during the subsequent two months of treatment and periodically thereafter, e.g. at each patient visit or as clinically indicated. Elevations of liver enzymes (ALT, AST, ALKP, gamma-glutamyl-transferase (GGT) and bilirubin were reversible upon dose reduction or interruption in the majority of cases. If transaminase (AST or ALT) elevations > 3x ULN are measured, dose reduction or interruption of the therapy with Nintedanib is recommended and the patient should be monitored closely. Once transaminases have returned to baseline values, treatment with Nintedanib may be resumed at the full dose (150 mg twice daily) or reintroduced at a reduced dose (100 mg twice daily) which subsequently may be increased to the full dose. If any liver test elevations are associated with clinical signs or symptoms of liver injury, e.g. jaundice, treatment with Nintedanib should be permanently discontinued. Alternative causes of the liver enzyme elevations should be investigated.
Patients with low body weight (<65 kg), Asian and female patients have a higher risk of elevations of liver enzymes. Nintedanib exposure increased linearly with patient age, which may also result in a higher risk of developing liver enzyme elevations. Close monitoring is recommended in patients with these risk factors.
Renal Function: Cases of renal impairment/failure, in some cases with fatal outcome, have been reported with Nintedanib use. Patients should be monitored during Nintedanib therapy, with particular attention to those patients exhibiting risk factors for renal impairment/failure. In case of renal impairment/failure, therapy adjustment should be considered.
Haemorrhage: Vascular endothelial growth factor receptor (VEGFR) inhibition might be associated with an increased risk of bleeding. In the INPULSIS trials with Nintedanib, the frequency of patients who experienced bleeding AEs was slightly higher in the Nintedanib arm (10.3%) than in the placebo arm (7.8%). Non-serious epistaxis was the most frequent bleeding event. Serious bleeding events occurred with low and similar frequencies in the 2 treatment groups (placebo: 1.4%; Nintedanib: 1.3%). Patients at known risk for bleeding including patients with inherited predisposition to bleeding or patients receiving a full dose of anti-coagulative treatment were not included in the INPULSIS studies. Non-serious and serious bleeding events, some of which were fatal, have been reported in the post-marketing period (including patients with or without anticoagulant therapy or other drugs that could cause bleeding). Therefore, these patients should only be treated with Nintedanib if the anticipated benefit outweighs the potential risk. Post-marketing bleeding events include but are not limited to gastrointestinal, respiratory and central nervous organ systems, with the most frequent being gastrointestinal.
Arterial thromboembolic events: Patients with a recent history of myocardial infarction or stroke were excluded from the INPULSIS trials. Arterial thromboembolic events were infrequently reported: in 0.7% of patients in the placebo and 2.5% in the Nintedanib treated group. While adverse events reflecting ischemic heart disease were balanced between the Nintedanib and placebo groups, a higher percentage of patients experienced myocardial infarctions in the Nintedanib group (1.6%) compared to the placebo group (0.5%). Caution should be used when treating patients at higher cardiovascular risk including known coronary artery disease. Treatment interruption should be considered in patients who develop signs or symptoms of acute myocardial ischemia.
Venous thromboembolism: In the INPULSIS trials no increased risk of venous thromboembolism was observed in Nintedanib treated patients. Due to the mechanism of action of Nintedanib patients might have an increased risk of thromboembolic events.
Gastrointestinal perforations: In the INPULSIS trials, the frequency of patients with perforation was very low in both treatment groups: 0% placebo, 0.3% Nintedanib (involving two patients). Due to the mechanism of action of Nintedanib patients might have an increased risk of gastrointestinal perforation. Cases of gastrointestinal perforations, some of which were fatal, have been reported in the post-marketing period. Particular caution should be exercised when treating patients with previous abdominal surgery, previous history of peptic ulceration, diverticular disease or receiving concomitant corticosteroids or NSAIDs. Nintedanib should only be initiated at least 4 weeks after abdominal surgery. Therapy with Nintedanib should be permanently discontinued in patients who develop gastrointestinal perforation.
Hypertension: Administration of Nintedanib may increase blood pressure. Systemic blood pressure should be measured periodically and as clinically indicated.
Wound healing complication: No increased frequency of impaired wound healing was observed in the INPULSIS trials. Based on the mechanism of action Nintedanib may impair wound healing. No dedicated studies investigating the effect of Nintedanib on wound healing were performed. Treatment with Nintedanib should therefore only be initiated or – in case of perioperative interruption – resumed based on clinical judgement of adequate wound healing.
Co-administration with Pirfenidone: In a dedicated pharmacokinetic study, concomitant treatment of Nintedanib with Pirfenidone was investigated in patients with IPF. Based on these results, there is no evidence of a relevant pharmacokinetic drug-drug interaction between Nintedanib and Pirfenidone when administered in combination. In view of the limited number of patients, this study detected only the most frequent adverse events and showed an increase in gastrointestinal adverse events and a trend toward increased hepatic adverse events. Given the similarity in safety profiles for both medicinal products, additive adverse events, including gastrointestinal and hepatic adverse events, may be expected. The benefit-risk balance of concomitant treatment with Pirfenidone has not been established.
Effect on QT interval: No evidence of QT prolongation was observed for Nintedanib in the clinical trial programme. As some other tyrosine kinase inhibitors are known to exert an effect on QT, caution should be exercised when administered Nintedanib in patients who may develop QTc prolongation.
Allergic reaction: Dietary soya products are known to cause allergic reactions including severe anaphylaxis in persons with soya allergy. Patients with known allergy to peanut protein carry an enhanced risk for severe reactions to soya preparations.
","Elderly patients (≥65 years): No overall differences in safety and efficacy were observed for elderly patients. No a-priori dose adjustment is required on the basis of a patient’s age. Patients ≥75 years may be more likely to require dose reduction to manage adverse effects.
Renal impairment: Less than 1% of a single dose of Nintedanib is excreted via the kidney. Adjustment of the starting dose in patients with mild to moderate renal impairment is not required. The safety, efficacy, and pharmacokinetics of Nintedanib have not been studied in patients with severe renal impairment (<30 ml/min creatinine clearance).
Hepatic impairment: Nintedanib is predominantly eliminated via biliary/faecal excretion (> 90%). Exposure increased in patients with hepatic impairment (Child Pugh A, Child Pugh B). In patients with mild hepatic impairment (Child Pugh A), the recommended dose of Nintedanib is 100 mg twice daily approximately 12 hours apart. In patients with mild hepatic impairment (Child Pugh A), treatment interruption or discontinuation for management of adverse reactions should be considered. The safety and efficacy of Nintedanib have not been investigated in patients with hepatic impairment classified as Child Pugh B and C. Treatment of patients with moderate (Child Pugh B) and severe (Child Pugh C) hepatic impairment with Nintedanib is not recommended.
Paediatric population: The safety and efficacy of Nintedanib in children aged 0-18 years have not been established. No data are available.
",,,,"Store in a cool and dry place, protected from light. Do not store above 25°C.
",12
+811,Nimodipine,nimodipine-811,https://medex.com.bd/attachments/14FwfMlQ7crUVOgnGOWacmP72vE1Vu/nimodipine-capsules-prescribing-information,Calcium-channel blockers,Stroke,"For the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms regardless of their post ictus neurological condition.
","Calcium-channel blockers
","Nimodipine inhibits inflow of Calcium ions into cells by blocking Calcium channels or select voltage-sensitive areas resulting in relaxation of vascular smooth muscle and myocardium during depolarisation. Nimodipine has greater action on the cerebral vessels because of its high lipophilicity.
","Adult: Initial dose is 60 mg in every four hours interval for 21 consecutive days, preferably not less than one hour before or two hours after meals. Oral Nimodipine therapy should be commence within 96 hours of the subarachnoid hemorrhage.
Use in Pediatric Patients: While there is no specific information on use of this medication in pediatric patients.
",,"Plasma concentration and efficacy may be significantly reduced when administered with strong CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenobarbital, phenytoin). May increase serum levels and toxicity of phenytoin. Increased plasma concentrations with cimetidine or sodium valproate.
","Use within 1 mth of MI or an episode of unstable angina. Concomitant use with potent CYP3A4 inhibitors (e.g. clarithromycin, ritonavir, ketoconazole, nefazodone).
","Although side effects from nimodipine are not common, the following can occur: headache, dizziness, flushing (feeling of warmth), heartburn, fast heartbeat, slow heartbeat, upset stomach, stomach pain, constipation, depression etc.
","Use in Pregnancy: Large doses of nimodipine have been shown to cause birth defects in animals. Human studies have not been done. Before you take nimodipine, tell your doctor if you are pregnant or plan to become pregnant.
Use in Nursing Mothers: Nimodipine may pass into breast milk but has not been reported to cause problems; caution is advised. Consult your doctor for advice.
","Patients with cerebral oedema or severely raised intracranial pressure. Contents of oral capsules should be given only by mouth or through a feeding tube. It must never be administered IV or by any other parenteral route. Hepatic impairment. Pregnancy and lactation.
",,"Symptoms: Excessive peripheral vasodilation, systemic hypotension, tachycardia, bradycardia, GI complaints, nausea.
Management: Symptomatic and supportive treatment. Admin of vasopressor may be necessary if significant hypotension occurs. IV Ca salts have been also used for hypotension.
",,,"Store between 15-30° C. Protect from light.
",11
+810,Nimesulide,nimesulide-810,https://medex.com.bd/attachments/5X6RbQ9hXbebBq8gwlLzROxh7niN9F/nimesulide-prescribing-information,Non-steroidal Anti-inflammatory Drugs (NSAIDs),Primary dysmenorrhoea,"Nimesulide is indicated in acute pain; extra-articular disorders; osteoarthritis; post-op pain; primary dysmenorrhoea
","Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Nimesulide is a nonsteroidal anti-inflammatory drug (NSAID) with anti-inflammatory, anti-pyretic, and analgesic properties. It inhibits prostaglandin synthetase/cyclooxygenase, which limits prostaglandin production. Its cyclooxygenase inhibiting potency is intermediate, but is relatively selective for the cyclo-oxygenase-2 (COX-2) thus the potential for gastric injury and intolerance is less. It is also a free radical scavenger, and helps protect against the tissue damage that occurs during inflammation.
","100 mg twice daily. Should be taken with food. Take after meals.
",,"Additive hepatotoxic effects with known hepatotoxins: anti-convulsants (e.g. valproic acid), anti-fungals (e.g. ketoconazole), anti-tuberculous drugs (e.g. isoniazid), tacrine, pemoline, amiodarone, methotrexate, methyldopa, amoxicillin/clavulanic acid. May decrease the oral bioavailability of furosemide and the natriuretic and diuretic response to furosemide. Increased risks of GI and hepatic adverse effects with other NSAIDs, including aspirin. May increase anti-coagulant effect of warfarin. Potentiates the action of phenytoin. May be displaced from binding sites with fenofibrate, salicylic acid, and tolbutamide. Interactions between NSAIDs and lithium, probenecid and ciclosporin, have been documented.
","Hypersensitivity; GI bleeding, active peptic ulcer disease; severe renal and heart failure; hepatic impairment or known liver disease; coagulation disorders; pregnancy; children <12 yr.
","Epigastric discomfort, heartburn or abdominal cramps, nausea, vomiting and diarrhoea; skin rash, pruritus, oedema, headache, dizziness, drowsiness; hypersensitivity reactions (e.g. bronchospasm, rhinitis, angioedema urticaria); GI haemorrhage/perforation; bullous/erosive stomatitis, purpura, thrombocytopenia, toxic epidermal necrolysis, haematuria, oliguria, and renal failure; increases in liver enzymes.
","Category not classified
","History of GI tract disease, infections, oedema, hypertension, elderly, lactation.
",,"Epigastric pain, nausea, vomiting, drowsiness, lethargy, GI haemorrhage, seizures, hypertension, apnoea, coma, anaphylactic reactions and renal failure. Treatment is supportive.
",,,"Protect from heat and humidity; store at <25°C.
",11
+809,Nilotinib,nilotinib-809,https://medex.com.bd/attachments/aWiCwrGtJLCjIVwyXhWDWSIDbSGy1O/nilotinib-prescribing-information,Targeted Cancer Therapy,Leukemia,"Nilotinib is indicated in advanced renal cell carcinoma (RCC), advanced soft tissue sarcoma (STS) who have received prior chemotherapy. The efficacy of Nilotinib 200 for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors has not been demonstrated.
","Targeted Cancer Therapy
","Pazopanib is a multi-tyrosine kinase inhibitor of vascular endothelial growth factor receptor (VEGFR)-1, VEGFR-2, VEGFR-3, platelet-derived growth factor receptor (PDGFR) and fibroblast growth factor receptor (FGFR)-1 and -3, cytokine receptor (Kit), interleukin-2 receptor-inducible T- cell kinase (Itk), lymphocyte-specific protein tyrosine kinase (Lck), and transmembrane glycoprotein receptor tyrosine kinase (c-Fms). In vitro, Pazopanib inhibited ligand-induced autophosphorylation of VEGFR-2, Kit, and PDGFR receptors.
Absorption: Pazopanib is absorbed orally with the median time to achieve peak concentrations of 2 to 4 hours after the dose. Daily dosing at 800 mg results in geometric mean AUC and Cmax of 1,037 mcg/mL and 58.1 mcg/mL (equivalent to 132 μM), respectively. There was no consistent increase in AUC or Cmax at Pazopanib doses above 800 mg.
Distribution: Binding of Pazopanib to human plasma protein in vivo was greater than 99% with no concentration dependence over the range of 10 to 100 mcg/mL. In vitro, studies suggest that Pazopanib is a substrate for P-gp and BCRP.
Metabolism: In vitro studies demonstrated that Pazopanib is metabolized by CYP3A4 with a minor contribution from CYP1A2 and CYP2C8.
Elimination: Pazopanib has a mean half-life of 30.9 hours after administration of the recommended dose of 800 mg. Elimination is primarily via feces with renal elimination accounting for less than 4% of the administered dose.
","The recommended starting dose of Pazopanib is 800 mg orally once daily without food (at least 1 hour before or 2 hours after a meal). The dose of Pazopanib should not exceed 800 mg. Tablets should not be crushed due to the potential for an increased rate of absorption which may affect systemic exposure. If a dose is missed, it should not be taken if it is less than 12 hours until the next dose or as directed by the registered physicians.
Pediatric Use: The safety and effectiveness of Pazopanib in pediatric patients have not been established.
","Should be taken on an empty stomach. Avoid food at least 2 hr before & at least 1 hr after a dose. Swallow whole, do not chew/crush. Avoid grapefruit products.
","Drugs that Inhibit or Induce Cytochrome P450 3A4 Enzymes: In vitro studies suggested that the oxidative metabolism of Pazopanib in human liver microsomes is mediated primarily by CYP3A4, with minor contributions from CYP1A2 and CYP2C8. Therefore, inhibitors and inducers of CYP3A4 may alter the metabolism of Pazopanib.
CYP3A4 Inhibitors: Co-administration of Pazopanib with strong inhibitors of CYP3A4 (e.g., Ketoconazole, Ritonavir, Clarithromycin) increases Pazopanib concentrations and should be avoided. Consider an alternate concomitant medication with no or minimal potential to inhibit CYP3A4. If co-administration of a strong CYP3A4 inhibitor is warranted, reduce the dose of Pazopanib to 400 mg. Grapefruit or grapefruit juice should be avoided as it inhibits CYP3A4 activity and may also increase plasma concentrations of Pazopanib.
CYP3A4 Inducers: CYP3A4 inducers, such as Rifampin, may decrease plasma Pazopanib concentrations. Consider an alternate concomitant medication with no or minimal enzyme induction potential. Pazopanib should not be used if chronic use of strong CYP3A4 inducers cannot be avoided.
Drugs that Inhibit Transporters: In vitro studies suggested that Pazopanib is a substrate of P- glycoprotein (P gp) and breast cancer resistance protein (BCRP). Therefore, absorption and subsequent elimination of Pazopanib may be influenced by products that affect P-gp and BCRP. Concomitant treatment with strong inhibitors of P-gp or BCRP should be avoided due to the risk of increased exposure to Pazopanib. The selection of alternative concomitant medicinal products with no or minimal potential to inhibit P-gp or BCRP should be considered.
Effects of Pazopanib on CYP Substrates: Results from drug-drug interaction trials conducted in cancer patients suggest that Pazopanib is a weak inhibitor of CYP3A4, CYP2C8, and CYP2D6 in vivo, but had no effect on CYP1A2, CYP2C9, or CYP2C19. Concomitant use of Pazopanib with agents with narrow therapeutic windows that are metabolized by CYP3A4, CYP2D6, or CYP2C8 is not recommended. Co-administration may result in inhibition of the metabolism of these products and create the potential for serious adverse events.
Effect of Concomitant Use of Pazopanib and Simvastatin: Concomitant use of Pazopanib and Simvastatin increases the incidence of ALT elevations. Across monotherapy trials with Pazopanib, ALT greater than 3 x ULN was reported in 126/895 (14%) of patients who did not use statins, compared with 11/41 (27%) of patients who had concomitant use of Simvastatin. If a patient receiving concomitant Simvastatin develops ALT elevations, follow dosing guidelines for Pazopanib or consider alternatives to Pazopanib. Alternatively, consider discontinuing Simvastatin. Insufficient data are available to assess the risk of concomitant administration of alternative statins and Pazopanib.
","It is contraindicated in patients with known hypersensitivity to Pazopanib or any other components of this product.
","Rash, pruritus, hepatotoxicity, headache, fever, fatigue, GI disturbances (nausea, constipation, diarrhoea), alopecia, asthenia, muscle spasms, arthralgia, myalgia, pain (e.g. musculoskeletal or chest pain), oedema, folliculitis, papilloma, insomnia, dizziness, vertigo, anxiety, paraesthesia, hyperhidrosis, dry skin, urticaria, acne, conjunctivitis, dry eye, flushing, dyspnoea, cough, myelosuppression (e.g. thrombocytopenia, neutropenia, and anaemia), thrombotic disorders or haemorrhage, arrhythmias, heart failure, pericarditis, palpitations, HTN, angina, MI; elevated AST/ALT, serum lipase; electrolyte imbalances.
","Pazopanib can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform a drug-associated risk. Pregnant women or women should be advised of the childbearing potential of the risk to a fetus. There is no information regarding the presence of Pazopanib or its metabolites in human milk, or their effects on the breastfed infant, or on milk production. Because of the potential for serious adverse reactions in breastfed infants from Pazopanib, a lactating woman should be advised not to breastfeed during treatment with Pazopanib and for 2 weeks after the final dose.
Females contraception: Females of reproductive potential should be advised to use effective contraception during treatment and for at least 2 weeks after the last dose of Pazopanib.
Males contraception: To avoid potential drug exposure to pregnant partners and female partners of reproductive potential, male patients (including those who have had vasectomies) with female partners of reproductive potential should be advised to use condoms during treatment with Pazopanib and for at least 2 weeks after the last dose.
","Hepatic Toxicity and Hepatic Impairment: In clinical trials with Pazopanib, hepatotoxicity, manifested as increases in serum transaminases (alanine transferase [ALT], aspartate aminotransferase [AST]) and bilirubin, was observed. This hepatotoxicity can be severe and fatal. Patients older than 65 years are at greater risk for hepatotoxicity. Transaminase elevations occur early in the course of treatment (92.5% of all transaminase elevations of any grade occurred in the first 18 weeks).
QT Prolongation and Torsades De Pointes: In the RCC trials of Pazopanib, QT prolongation (greater than or equal to 500 msec) was identified on routine electrocardiogram (ECG) monitoring in 2% (11/558) of patients. Torsades de pointes occurred in less than 1% (2/977) of patients who received Pazopanib in the monotherapy trials. Pazopanib should be used with caution in patients with a history of QT interval prolongation, in patients taking antiarrhythmics or other medications that may prolong QT interval, and those with relevant pre-existing cardiac disease. When using Pazopanib, baseline and periodic monitoring of ECGs and maintenance of electrolytes (e.g., calcium, magnesium, potassium) within the normal range should be performed.
Hemorrhagic Events: Fatal hemorrhage occurred in 0.9% (5/586) in the RCC trials; there were no reports of fatal hemorrhage in the STS trials. In the randomized RCC trial, 13% (37/290) of patients treated with Pazopanib and 5% (7/145) of patients on placebo experienced at least 1 hemorrhagic event. The most common hemorrhagic events in the patients treated with Pazopanib were hematuria (4%), epistaxis (2%), hemoptysis (2%), and rectal hemorrhage (1%). Nine of 37 patients treated with Pazopanib, who had hemorrhagic events, experienced serious events including pulmonary, gastrointestinal, and genitourinary hemorrhage. One percent (4/290) of patients treated with Pazopanib died from hemorrhage compared with no (0/145) patients on placebo. In the overall safety population in RCC (N = 586), cerebral/intracranial hemorrhage was observed in less than 1% (2/586) of patients treated with Pazopanib.
Arterial Thromboembolic Events: Fatal arterial thromboembolic events were observed in 0.3% (2/586) of patients in the RCC trials and in no patients in the STS trials. In the randomized RCC trial, 2% (5/290) of patients receiving Pazopanib experienced myocardial infarction or ischemia, 0.3% (1/290) had a cerebrovascular accident, and 1% (4/290) had an event of transient ischemic attack. In the randomized STS trial, 2% (4/240) of patients receiving Pazopanib experienced a myocardial infarction or ischemia, 0.4% (1/240) had a cerebrovascular accident, and there were no incidents of transient ischemic attack. No arterial thromboembolic events were reported in patients who received placebo in either trial. Pazopanib should be used with caution in patients who are at increased risk for these events or who have had a history of these events. Pazopanib has not been studied in patients who have had an arterial thromboembolic event within the previous 6 months and should not be used in those patients.
Venous Thromboembolic Events: In RCC and STS trials of Pazopanib, venous thromboembolic events (VTEs), including venous thrombosis and fatal pulmonary embolus (PE), have occurred. In the randomized STS trial, VTEs were reported in 5% of patients treated with Pazopanib compared with 2% with placebo. In the randomized RCC trial, the rate was 1% in both arms. Fatal PE occurred in 1% (2/240) of STS patients receiving Pazopanib and in no patients receiving placebo. There were no fatal pulmonary emboli in the RCC trial. Monitor for signs and symptoms of VTE and PE.
Thrombotic Microangiopathy: Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS), has been reported in clinical trials of Pazopanib as monotherapy, in combination with Bevacizumab, and in combination with Topotecan. Pazopanib is not indicated for use in combination with other agents. Six of the 7 TMA cases occurred within 90 days of the initiation of Pazonib-200. Improvement of TMA was observed after treatment was discontinued. Monitor for signs and symptoms of TMA. Permanently discontinue Pazopanib in patients developing TMA. Manage as clinically indicated.
Gastrointestinal Perforation and Fistula: In the RCC and STS trials, gastrointestinal perforation or fistula occurred in 0.9% (5/586) of patients and 1% (4/382) of patients receiving Pazopanib, respectively. Fatal perforations occurred in 0.3% (2/586) of these patients in the RCC trials and in 0.3% (1/382) of these patients in the STS trials. Monitor for signs and symptoms of gastrointestinal perforation or fistula.
Interstitial Lung Disease/Pneumonitis: Interstitial lung disease (ILD)/pneumonitis, which can be fatal, has been reported in association with Pazopanib. In clinical trials, ILD/pneumonitis occurred in 0.1% of patients treated with Pazopanib.. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis and discontinue Pazopanib in patients developing ILD or pneumonitis.
Reversible Posterior Leukoencephalopathy Syndrome: Reversible Posterior Leukoencephalopathy Syndrome (RPLS) has been reported in patients receiving Pazopanib and may be fatal. RPLS is a neurological disorder that can present with headache, seizure, lethargy, confusion, blindness, and other visual and neurologic disturbances. Mild to severe hypertension may be present. The diagnosis of RPLS is optimally confirmed by magnetic resonance imaging. Permanently discontinue Pazopanib in patients developing RPLS.
Wound Healing: No formal trials on the effect of Pazopanib on wound healing have been conducted. Since vascular endothelial growth factor receptor (VEGFR) inhibitors such as Pazopanib may impair wound healing, treatment with Pazopanib should be stopped at least 7 days prior to scheduled surgery. The decision to resume Pazopanib after surgery should be based on clinical judgment of adequate wound healing. Pazopanib should be discontinued in patients with wound dehiscence.
Hypothyroidism: Hypothyroidism, confirmed based on a simultaneous rise of TSH and decline of T4, was reported in 7% (19/290) of patients treated with Pazopanib in the randomized RCC trial and in 5% (11/240) of patients treated with Pazopanib in the randomized STS trial. No patients on the placebo arm of either trial had hypothyroidism. In RCC and STS trials of Pazopanib, hypothyroidism was reported as an adverse reaction in 4% (26/586) and 5% (20/382) of patients, respectively. Proactive monitoring of thyroid function tests is recommended.
Tumor Lysis Syndrome: Cases of tumor lysis syndrome (TLS), including fatal cases, have been reported in RCC and STS patients treated with Pazopanib. Patients may be at risk of TLS if they have rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Closely monitor patients at risk, consider appropriate prophylaxis, and treat as clinically indicated.
Infection: Serious infections (with or without neutropenia), including some with fatal outcome, have been reported. Monitor patients for signs and symptoms of infection. Institute appropriate anti-infective therapy promptly and consider interruption or discontinuation of Pazopanib for serious infections. Increased Toxicity with other Cancer Therapy: Pazopanib is not indicated for use in combination with other agents. Clinical trials of Pazopanib in combination with Pemetrexed and Lapatinib were terminated early due to concerns over increased toxicity and mortality. The fatal toxicities observed included pulmonary hemorrhage, gastrointestinal hemorrhage, and sudden death. A safe and effective combination dose has not been established with these regimens.
",,"Pazopanib doses up to 2000 mg have been evaluated in clinical trials. Dose-limiting toxicity (Grade 3 fatigue) and Grade 3 hypertension were each observed in 1 of 3 patients dosed at 2000 mg daily and 1000 mg daily, respectively. Treatment of overdose with Nilotinib should consist of general supportive measures. There is no specific antidote for overdosage of Nilotinib. Hemodialysis is not expected to enhance the elimination of Nilotinib because Pazopanib is not significantly renally excreted and is highly bound to plasma proteins.
",,,"Store in a cool (not above 30°C) and dry place, away from sunlight. Keep out of reach of children.
",12
+808,Nikethamide,nikethamide-808,,Respiratory stimulants: analeptics,Tranquilizer overdoses,"Nikethamide Injection is used for the treatment, control, prevention, & improvement of the following diseases, conditions and symptoms: Central nervous system stimulant, Barbiturate overdose
","Respiratory stimulants: analeptics
","Nikethamide was formerly used as a respiratory stimulant but its use for this indication is no longer recommended as the effective doses are close to those causing toxic effects (especially convulsions).
","1500 mg as single dose. Frequency: as recommended.
",,"Additive pressor effects with sympathomimetics or MAOIs. Increased risk of cardiac arrythmias with some anaesthetics (halothane, enflurane, isoflurane). May mask the effects of neuromuscular blockers. Increased risk of convulsions with bupropion.
","Porphyria, epilepsy or other convulsive disorders, cerebral oedema, cerebrovascular accident, head injury, acute severe asthma, physical obstruction of the airway, severe hypertension, ischaemic heart disease, hyperthyroidism, phaeochromocytoma.
","The following is a list of possible side-effects that may occur from all constituting ingredients of Nikethamide Injection: Skin irritation, Eye irritation, Respiratory irritation.
",,"Less severe degrees of hypertension or impaired cardiac reserve; liver dysfunction.
",,,,,,8
+807,Nifedipine,nifedipine-807,https://medex.com.bd/attachments/6iFuBh9SoTmMSGmLuSPx44sLHuV3k4/nifedipine-capsule-prescribing-information,Calcium-channel blockers,Stroke,"Nifedipine is indicated in the management of all types of essential & renal hypertension. Also indicated in the management of hypertension during pregnancy & during coronary by pass surgery.
Nifedipine is also used for prophylaxis and the treatment of unstable & variant angina ... Read more
Nifedipine is indicated in the management of all types of essential & renal hypertension. Also indicated in the management of hypertension during pregnancy & during coronary by pass surgery.
Nifedipine is also used for prophylaxis and the treatment of unstable & variant angina, myocardial infarction, and silent myocardial ischaemia. Moreover Nifedipine is also used in Raynaud's phenomenon & heart failure.
","Calcium-channel blockers
","Nifedipine is an inhibitor of Calcium Channel Blocker that blocks the transmembrane influx of Calcium ions into muscle cells. Nifedipine has selective effects as a dilator of arterial vessels. Nifedipine dilates main coronary and systemic arteries. As a result blood pressure falls and this elicits a sympathetic reflex response causing tachycardia and an increased cardiac output. Pulmonary arterial pressure also falls. Nifedipine has direct negative inotropic effects on cardiac muscles and these effects are seen at higher doses than dose which causes arterial vasodilatation.
","Nifedipine 10 mg:
+
+- Angina: Initially 10 mg 3 times daily with food increased to 20 mg 3 times daily if necessary, in elderly patients, initially 5 mg 3 times daily.
+- Raynaud's Phenomenon: 10 mg 3 times daily; maximum 60 mg daily. In urgent cases, the tablet should be dissolved under the tongue like a sublingual tablet. The effect occurs within some minutes.
+
+
Nifedipine 20 mg: The starting dose for patients, not previously prescribed Nifedipine products is one tablet once daily. The recommended dose in hypertension and angina prophylaxis is 20 mg twice daily during or after food. Dosage may be adjusted within the range 10 mg twice daily to 40 mg twice daily.
Patients with liver dysfunction should commence therapy with 10 mg twice daily with careful monitoring.
Patients with renal impairment do not require adjustment of dosage.
",,"
+- ACE inhibitors: Enhanced hypotensive effect.
+- Anti-arrythmics: Plasma concentration of quinidine is reduced.
+- Anti-bacterials: Rifampicin possibly increases metabolism of Nifedipine.
+- Anti-epileptics: Plasma concentration of phenytoin increases.
+- Antipsychotics: Enhanced hypotensive effect.
+- β-blockers: Occasionally severe hypotension and heart failure may occur.
+- Cyclosporin: Plasma concentration of Nifedipine possibly increases.
+- Muscle relaxants: Effect of muscle relaxants e.g. tubocurarine increases.
+- Ulcer healing drugs: Metabolism of Nifedipine increases.
+
","Cardiogenic shock, advanced aortic stenosis, nursing mothers, GI obstruction, inflammatory bowel disease, hypotension.
","Headache, flushing, lethargy, gravitational oedema rash, nausea, increased frequency of micturation, eye pain, gum hyperplasia, depression, tremor, photosensitivity and few cases of jaundice have been reported. These reactions may regress on discontinuation of therapy. Its introduction may induce attacks of ischaemic pain in some patients with angina pectoris.
","There are no adequate and well controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
","Tablets should be swallowed whole and should not be bitten, chewed or broken up. It should be used with caution in patient whose cardiac reserve is poor. Should be withdrawn if ischaemic pain occurs or existing pain worsens shortly after initiating treatment. Use in diabetic patients requires adjustment of their control. Since the absorption of the drug could be modified by renal disease, caution should be exercised in treating such patients.
",,,,,"Protect from strong light, store in a cool place in the original pack
",10
+805,Nicotinic Acid [Niacin],nicotinic-acid-niacin-805,https://medex.com.bd/attachments/N0qsnlESwNxRKAX8GcjAfSXB3jbvoE/nicotinic-acid-niacin-prescribing-information,,,"Niacin is indicated as an adjunct to diet for reduction of elevated TC, LDL-C, Apo B and TG level and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. when the response to an appropriate diet has been inadequate. In patients ... Read more
Niacin is indicated as an adjunct to diet for reduction of elevated TC, LDL-C, Apo B and TG level and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. when the response to an appropriate diet has been inadequate. In patients with a history of myocardial infarction and hypercholesterolemia, Niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction. Niacin is also indicated as adjunctive therapy for treatment of adult patients with very high serum triglyceride levels (Type IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Prior to initiating therapy with Niacin, secondary causes for hypercholesterolemia (e.g poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded and a lipid profile obtained to measure TC, HDL-C and TG.
",,"Niacin is a preparation of Nicotinic acid. It is proven effective at lowering VLDL, LDL, total cholesterol and triglyceride levels while raising HDL levels. So Niacin has been prescriped for the treatment of cardiovascular disease particularly the hyperlipidemias.
","Initial Dose: 500 mg tablet at bedtime from 1 to 4 weeks.
Maintenance Dose: the daily dosage should not be increased by more than 500 mg in any 4 week period. The recommended maintenance dose is 1000 mg (two tablet) to 2000 mg (4 tablets) once daily at bedtime. Dose greater than 2000 mg daily is not recommended. Or, as directed by the registered physician.
",,"Niacin may potentiate the effects of ganglionic blocking agents and vasoactive drugs resulting in postural hypotension. Concomitant aspirin may decrease the metabolic clearance of nicotinic acid. The clinical relevance of this finding is unclear. About 98% of available Niacin was bound to colestipol, with 10 to 30% binding to cholestyramine. These results suggest that 4 to 6 hours, or as great an interval as possible, should elapse between the ingestion of bile acid-binding resins and the administration of Niacin.
","Niacin is contraindicated in patients with a known hypersensitivity to Niacin or any component of this medication, significant or unexplained hepatic dysfunction, active peptic ulcer disease or arterial bleeding.
","Niacin is generally well tolerated; adverse reactions have been mild and transient. The most frequent advers effects were flushing, itching, pruritis, nausea and GI upset, jaundice, hypotension, tachycardia, increased serum blood glucose and uric acid levels, myalgia.
","Niacin cannot be used in pregnancy and lactation because of a lack of information.
","Before instituting therapy with Niacin, an attempt should be made to control hyperlipidemia with appropriate diet, exercise, and weight reduction in obese patients and to treat other underlying medical problems. Patients with a past history of jaundice, hepatobiliary disease, or peptic ulcer should be observed closely during Niacin therapy. Frequent monitoring of liver function tests and blood glucose should be performed to ascertain that the drug is producing no adverse effects on these organ systems. Diabetic patients may experience a dose-related rise in glucose intolerance, the clinical significance of which is unclear. Diabetic or potentially diabetic patients should be observed closely. Adjustment of diet and/or hypoglycemic therapy may be necessary.
Caution should also be used when Niacin is used in patients with unstable angina or in the acute phase of MI, particularly when such patients are also receiving vasoactive drugs such as nitrates, calcium channel blockers or adrenergic blocking agents. Elevated uric acid levels have occurred with Niacin therapy, therefore use with caution in patients predisposed to gout. Niacin has been associated with small but statistically significant dose-related reductions in platelet count and increases in prothrombin time. Caution should be observed when Niacin is administered concomitantly with anticoagulants; prothrombin time and platelet counts should be monitored closely in such patients. Niacin has been associated with small but statistically significant, dose-related reductions in phosphorus levels (mean of -13% with 2000 mg). So phosphorus levels should be monitored periodically in patients at risk.
",,"Supportive measures should be undertaken in the event of an overdosage. Symptoms may include nausea, dizziness, itching, vomiting, upset stomach, and flushing
",,,"Store in a cool and dry place, protect from light and moisture. Keep all medicines out of the reach of the children.
",10
+806,Nicorandil,nicorandil-806,https://medex.com.bd/attachments/B4jgwlhC6uD1ubJ0aFSP7rTaAQ26LA/nicorandil-prescribing-information,Potassium-channel activator,Ischaemic heart disease,"Nicorandil is indicated for the prevention and long-term treatment of angina pectoris.
","Potassium-channel activator
","Nicorandil dilates arterioles and large coronary arteries by opening the potassium channels, and stimulates guanylate cyclase causing venous vasodilatation. It therefore reduces preload and afterload, and improves coronary blood flow.
","Adult: The usual therapeutic range is 10 to 20 mg twice daily. The usual starting dose is 10 mg twice daily, in the morning and in the evening preferably, and should be titrated upwards in accordance with patients needs, response and tolerance up to 40 mg twice daily, if necessary. An even lower starting dose of 5 mg twice daily may be used in patients particularly prone to headache.
Eldery: There are no special dosage requirements for elderly patients, but as with all medicines the lowest effective dose should be used. Nicorandil should be administered with care, using low starting dosages, in the elderly.
Children: Not recommended. Nicorandil should be used with caution in patients with serious hepatic dysfunction.
Hepatic Impairment: Dose reduction may be necessary.
",,"Although no pharmacological and/or pharmacokinetic interaction has been obsen/ed in animal and human studies with Nicorandil associated with beta-blockers, calcium antagonists, digoxin, a combination of digoxin/furosemide, rifampicin, and cimetidine, it is not excluded that the drug may nevertheless potentiate the effect of other vasodilators, tricyclic antidepressants and antihypertensive drugs administered concurrently, especially in combination with alcohol.
","Nicorandil tablet is contra-indicated in patients who have shown hypersensitivity to Nicorandil. Use is contra-indicated with cardiogenic shock and acute myocardial infarction with acute left ventricular failure and low filling pressures, in patients with hypotension, and in patients taking phosphodiesterase-5 inhibitors because concurrent use of Nicorandil can lead to a serious drop in blood pressure. Warnings and precautions: Nicorandil should be used with caution in patients who may have blood volume depletion or in those who present with low systolic blood pressure (below 100 mm Hg). The use of the drug in patients with cardiogenic shock, or acute myocardial infarction with acute left ventricular failure and low filling pressures should be avoided. Nicorandil should be discontinued and appropriate measures taken if mouth ulceration, stomatitis or persistent or severe buccal ulcerations, appear. Caution is advised for the use of Nicorandil in patients with glaucoma. The hypotensive effect of other vasodilators, tricyclic antidepressants or alcohol can be increased by administration in combination with Nicorandil. Therapeutic doses of Nicorandil may lower the blood pressure of hypertensive patients and Nicorandil therefore, as with other antianginal agents, should be used with care when prescribed with antihypertensive drugs. Animal mutagenicify and carcinogenicity studies have not revealed any adverse effect of Nicorandil when used under experimental conditions.
","Headache (usually transitory), flushing, dizziness, nausea, vomiting and weakness. Hypotension and reflex tachycardia at high doses.
","Although animal studies have not shown any harmful effect of Nicorandil to the foetus, has not been studied in human pregnancy. Use in pregnant women requires that the anticipated benefit be weighed against possible hazard. It is not known whether the drug is excreted in human milk. Caution should be exercised when Nicorandil is administered to a nursing mother. Drug interactions: Although no pharmacological and/or pharmacokinetic interaction has been obsen/ed in animal and human studies with Nicorandil associated with beta-blockers, calcium antagonists, digoxin, a combination of digoxin/furosemide, rifampicin, and cimetidine, it is not excluded that the drug may nevertheless potentiate the effect of other vasodilators, tricyclic antidepressants and antihypertensive drugs administered concurrently, especially in combination with alcohol.
","Hypovolaemia, low systolic BP, acute pulmonary oedema, pregnancy. May impair ability to drive or operate machinery.
",,"ln the case of overdosage, the likely symptomatology may be peripheral vasodilation with a fall in blood pressure and reflex tachycardia. In such an event, monitoring of cardiac function and general supportive measures should be used. If not successful, circulating plasma volume should be increased by substitution of fluid. ln life-threatening situations, administration of vasopressors should be considered.
",,,"Store in a cool and dry place, protected from light.
",11
+1228,Nevirapine,nevirapine-1228,https://medex.com.bd/attachments/YJQZm9tcPMfwl3D8iooaXZZ0gLNIzD/nevirapine-prescribing-information,Drugs for HIV / Anti-retroviral drugs,HIV infection,"Nevirapine is indicated for combination antiretroviral treatment of HIV-1 infection in adults and in pediatric patients 15 days and older.
Additional important information regarding the use of Nevirapine for the treatment of HIV-1 infection:
+
+- Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, Nevirapine should not be initiated in adult females with CD4+ cell counts greater than 250 cells/mm³ or in adult males with CD4+ cell counts greater than 400 cells/mm³ unless the benefit outweighs the risk.
... Read more
Nevirapine is indicated for combination antiretroviral treatment of HIV-1 infection in adults and in pediatric patients 15 days and older.
Additional important information regarding the use of Nevirapine for the treatment of HIV-1 infection:
+
+- Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, Nevirapine should not be initiated in adult females with CD4+ cell counts greater than 250 cells/mm³ or in adult males with CD4+ cell counts greater than 400 cells/mm³ unless the benefit outweighs the risk.
+- The 14-day lead-in period with Nevirapine 200 mg daily dosing must be strictly followed; it has been demonstrated to reduce the frequency of rash.
+- If rash persists beyond the 14-day lead-in period, do not dose escalate to 200 mg twice daily. The 200 mg once-daily dosing regimen should not be continued beyond 28 days, at which point an alternative regimen should be sought.
+
","Drugs for HIV / Anti-retroviral drugs
","Nevirapine is a non-nucleoside reverse transcriptase inhibitor that acts against HIV-1. It binds directly to reverse transcriptase and thereby blocks the RNA-dependent and DNA-dependent DNA polymerase activities by disrupting the enzyme's catalytic site.
","Adult Patients: The recommended dose for Nevirapine is one 200 mg tablet daily for the first 14 days, followed by one 200 mg tablet twice daily, in combination with other antiretroviral agents. The lead-in period has been observed to decrease the incidence of rash. For concomitantly administered antiretroviral therapy, the manufacturer's recommended dosage and monitoring should be followed.
Pediatric Patients: The recommended oral dose for pediatric patients 15 days and older is 150 mg/m² once daily for 14 days followed by 150 mg/m² twice daily thereafter. The total daily dose should not exceed 400 mg for any patient.
","May be taken with or without food.
","Mutually increased levels effects when used with drugs extensively metabolised by CYP3A. Reduced levels/effects of methadone.
","Hypersensitivity. Lactation. Severe hepatic impairment.
","Skin rash, nausea, vomiting, headache, abnormal LFT, fatigue, diarrhoea, abdominal pain.
","Nursing Mothers: The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1. Nevirapine is excreted in breast milk. Because of both the potential for HIV-1 transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving Nevirapine.
","Caution should be taken during pregnancy. Interrupt treatment if severe hepatotoxicity or life-threatening skin reactions develop. Renal or hepatic insufficiency. Monitor liver function periodically.
","Pediatric Use: The safety, pharmacokinetic profile, and virologic and immunologic responses of Nevirapine have been evaluated in HIV-1 infected pediatric subjects age 3 months to 18 years. The safety and pharmacokinetic profile of Nevirapine has been evaluated in HIV-1 infected pediatric subjects age 15 days to less than 3 months.
The most frequently reported adverse events related to Nevirapine in pediatric subjects were similar to those observed in adults, with the exception of granulocytopenia, which was more commonly observed in children receiving both zidovudine and Nevirapine.
Geriatric Use: Clinical trials of Nevirapine did not include sufficient numbers of subjects aged 65 and older to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Renal Impairment: In subjects with renal impairment (mild, moderate or severe), there were no significant changes in the pharmacokinetics of nevirapine. Nevirapine is extensively metabolized by the liver and nevirapine metabolites are extensively eliminated by the kidney. Nevirapine metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known. No adjustment in nevirapine dosing is required in patients with CrCL greater than or equal to 20 mL per min. The pharmacokinetics of nevirapine have not been evaluated in patients with CrCl less than 20 mL per min. In patients undergoing chronic hemodialysis, an additional 200 mg dose following each dialysis treatment is indicated.
Hepatic Impairment: Because increased nevirapine levels and nevirapine accumulation may be observed in patients with serious liver disease, do not administer Nevirapine to patients with moderate or severe (Child-Pugh Class B or C, respectively) hepatic impairment.
","There is no known antidote for Nevirapine overdosage. Cases of Nevirapine overdose at doses ranging from 800 to 1800 mg per day for up to 15 days have been reported. Patients have experienced events including edema, erythema nodosum, fatigue, fever, headache, insomnia, nausea, pulmonary infiltrates, rash, vertigo, vomiting, and weight decrease. All events subsided following discontinuation of Nevirapine.
",,,"Store at 15-30° C
",13
+1928,Netarsudil Dimesylate,netarsudil-dimesylate-1928,https://medex.com.bd/attachments/O2q96poErCdYF0zJOB4Y0Vbbq9RD48/netarsudil-dimesylate-prescribing-information,Drugs for miotics and glaucoma,,"Netarsudil ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
","Drugs for miotics and glaucoma
","Netarsudil is a Rho kinase inhibitor, works at the cellular level within the trabecular outflow pathway to relax actin-myosin. This causes relaxation within the trabecular meshwork and the inner wall of Schlemm's canal and decreases episcleral venous pressure (EVP).
","The recommended dosage is one drop in the affected eye(s) once daily in the evening.
",,"This eye drops is contraindicated in patients who are hypersensitive to any component of this preparation.
",,"The most common ocular adverse reaction observed in controlled clinical studies with Netarsudil was conjunctival hyperemia, corneal verticillata, instillation site pain, corneal staining and blurred vision.
","Pregnancy: There are no adequate and well-controlled studies of Netarsudil ophthalmic solution in pregnant women to inform any drug-associated risk. However, systemic exposure to Netarsudil from ocular administration is low.
Lactation: There are no data on the presence of Netarsudil in human milk, the effects on the breastfed infant, or the effects on milk production.
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 18 years have not been established.
Use in elderly patients: No overall differences in safety and effectiveness have been observed between elderly and other adult patients.
","For ophthalmic use only. To avoid possible contamination of the drops, do not touch the dropper tip or to any surface. Netarsudil can be used with other topical eye drug products, but they should be administered at least 5 minutes apart from each other. Contact lenses should be removed prior to instillation of Netarsudil and may be reinserted 15 minutes following its administration.
",,,,,"Store at 2°-8°C in a dry place, protect from light until opened. After opening the product may be kept at 2°-25°C for upto 6 weeks. Keep out of the reach of children.
",9
+1838,Netarsudil + Latanoprost,netarsudil-latanoprost-1838,https://medex.com.bd/attachments/opYAGHtu8ujKiQu87HbYfeiENkFZkC/netarsudil-latanoprost-prescribing-information,Drugs for miotics and glaucoma,Open angle glaucoma,"This is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
","Drugs for miotics and glaucoma
","This is a fixed-dose combination of a Rho kinase inhibitor and a Prostaglandin F2 analogue. Netarsudil is a Rho kinase inhibitor, works at the cellular level within the trabecular outflow pathway to relax actin-myosin. This causes relaxation within the trabecular meshwork and the inner wall of Schlemm's canal, and decrease episcleral venous pressure (EVP).
Latanoprost is a selective FP receptor agonist which reduces the intraocular pressure (IOP) by increasing the outflow of aqueous humor through uveoscleral outflow.
","The recommended dosage is one drop in the affected eye(s) once daily in the evening.
",,,"This eye drops is contraindicated in patients who are hypersensitive to any component of this preparation.
","The most common ocular adverse reaction observed in controlled clinical studies with Netarsudil & Latanoprost was conjunctival hyperemia, instillation site pain, corneal verticillata, instillation site discomfort, foreign body sensation and blurred visions were reported in few patients.
","There are no adequate and well-controlled studies of Netarsudil & Latanoprost combination in pregnant women to inform any drug-associated risk. There are no data on the presence of Netarsudil or Latanoprost in human milk, the effects on the breastfed infant, or the effects on milk production.
","
+- For ophthalmic use only
+- To avoid possible contamination of the drops, do not touch the dropper tip or to any surface
+- Should be used with caution in patients with active intraocular inflammation (e.g., iritis/uveits)
+- May cause changes to pigmented tissues, gradually change eyelashes and vellus hair in the treated eye
+- Cystoid macular edema, has been reported during treatment with Latanoprost. Reactivation of Herpes Simplex keratitis may occur
+- Netarsudil & Latanoprost combination can be used with other topical eye drug products, but they should be administered at least 5 minutes apart from each other.
+
","Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Use in elderly patients: No overall differences in safety and effectiveness have been observed between elderly and other adult patients.
",,,,"Store at 2°-8°C in a dry place, protect from light until opened. After opening the product may be kept at 2°-25°C for upto 6 weeks. Keep out of the reach of children.
",10
+1486,Neratinib,neratinib-1486,https://medex.com.bd/attachments/aFiOpxtrV3CiJfKr29i0ZQT2Ib9odM/neratinib-prescribing-information,Tyrosine Kinase Inhibitor,Breast cancer,"Extended Adjuvant Treatment of Early-Stage Breast Cancer: Neratinib as a single agent is indicated for the extended adjuvant treatment of adult patients with early-stage human epidermal growth factor receptor 2 (HER 2 )- positive breast cancer, to follow adjuvant Trastuzumab-based therapy ... Read more
Extended Adjuvant Treatment of Early-Stage Breast Cancer: Neratinib as a single agent is indicated for the extended adjuvant treatment of adult patients with early-stage human epidermal growth factor receptor 2 (HER 2 )- positive breast cancer, to follow adjuvant Trastuzumab-based therapy.
Advanced or Metastatic Breast Cancer: Neratinib in combination with Capecitabine is indicated for the treatment of adult patients with advanced or metastatic HER 2 -positive breast cancer who have received two or more prior anti-HER 2 based regimens in the metastatic setting.
","Tyrosine Kinase Inhibitor
","Neratinib is a kinase inhibitor that irreversibly binds to Epidermal Growth Factor Receptor (EGFR), Human Epidermal Growth Factor Receptor 2 (HER2), and HER4. In vitro, Neratinib reduces EGFR and HER2 autophosphorylation, downstream MAPK and AKT signaling pathways, and showed antitumor activity in EGFR and/or HER2 expressing carcinoma cell lines. Neratinib human metabolites M3, M6, M7 and M11 inhibited the activity of EGFR, HER2 and HER4 in vitro. In vivo, oral administration of Neratinib inhibited tumor growth in mouse xenograft models with tumor cell lines expressing HER2 and EGFR.
Absorption: The Neratinib and major active metabolites M3, M6 and M7 peak concentrations are reached in the range of 2 to 8 hours after oral administration.
Distribution: In patients, following multiple doses of Neratinib, the mean (%CV) apparent volume of distribution at steady-state (Vss/F) was 6433 (19%) L. In vitro protein binding of Neratinib in human plasma was greater than 99% and independent of concentration. Neratinib bound predominantly to human serum albumin and human alpha-1 acid glycoprotein.
Elimination: Following 7 days of daily 240 mg oral doses of Neratinib in healthy subjects, the mean (%CV) plasma half-life of Neratinib, M3, M6, and M7 was 14.6 (38%), 21.6 (77%), 13.8 (50%) and 10.4 (33%) hours, respectively. The mean elimination half-life of Neratinib ranged from 7 to 17 hours following a single oral dose in patients. Following multiple doses of Neratinib at once daily 240 mg in cancer patients, the mean (%CV) CL/F after first dose and at steady state (day 21) were 216 (34%) and 281 (40%) L/hour, respectively.
Metabolism: Neratinib is metabolized primarily in the liver by CYP3A4 and to a lesser extent by flavin-containing monooxygenase (FMO).
Excretion: After oral administration of 200 mg (0.83 times of approved recommended dosage) radiolabeled neratinib oral formulation, fecal excretion accounted for approximately 97.1% and urinary excretion accounted for 1.13% of the total dose. Sixty one percent of the excreted radioactivity was recovered within 96 hours and 98% was recovered after 10 days.
","Antidiarrheal Prophylaxis: Antidiarrheal prophylaxis is recommended during the first 2 cycles (56 days) of treatment and should be initiated with the first dose of Neratinib. Additional antidiarrheal agents may be required to manage diarrhea in patients with loperamide-refractory diarrhea. Neratinib dose interruptions and dose reductions may also be required to manage diarrhea. The recommended dose of Neratinib is 240 mg (six tablets) given orally once daily with food, continuously for one year. Patients should be instructed to take Neratinib at approximately the same time every day. Neratinib tablets should be swallowed whole (tablets should not be chewed, crushed, or split prior to swallowing). If a patient misses a dose, missed dose should not be replaced, and patients should be instructed to resume Neratinib with the next scheduled daily dose. Or, as directed by the registered physicians.
Dose Modifications: For Adverse Reactions: Neratinib dose modification is recommended based on individual safety and tolerability. Neratinib should be discontinued for patients who fail to recover to Grade 0-1 from treatment-related toxicity, for toxicities that result in a treatment delay >3 weeks, or for patients that are unable to tolerate 120 mg daily. Additional clinical situations may result in dose adjustments as clinically indicated (e.g. intolerable toxicities, persistent Grade 2 adverse reactions, etc.).
Recommended starting dose: 240 mg daily
First dose reduction: 200 mg daily
Second dose reduction: 160 mg daily
Third dose reduction: 120 mg daily
",,"Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors (PPI) and H2-receptor antagonists. Separate Neratinib by 3 hours after antacid dosing.
Strong or moderate CYP3A4 inhibitors: Avoid concomitant use.
Strong or moderate CYP3A4 inducers: Avoid concomitant use.
P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of narrow therapeutic agents that are P-gp substrates when used concomitantly with Neratinib.
","It is contraindicated in patients with known hypersensitivity to Neratinib or any other components of this product.
","Diarrhea, Hepatotoxicity.
","Neratinib can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. Pregnant women should be advised of the potential risk to a fetus. No data are available regarding the presence of Neratinib or its metabolites in human milk or its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in breastfed infants from Neratinib, lactating women should be advised not to breastfeed while taking Neratinib and for at least 1 month after the last dose.
Neratinib can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should have a pregnancy test prior to starting treatment with Neratinib. Females: Females of reproductive potential should be advised to use effective contraception during treatment with Neratinib and for at least 1 month after the last dose. Males: Male patients with female partners of reproductive potential should be advised to use effective contraception during treatment and for 3 months after the last dose of Neratinib.
","Diarrhea: Aggressively manage diarrhea occurring despite recommended prophylaxis with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold Meratinib in patients experiencing severe and/or persistent diarrhea. Permanently discontinue Meratinib in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction.
Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold Meratinib in patients experiencing Grade 3 liver abnormalities and permanently discontinue Meratinib in patients experiencing Grade 4 liver abnormalities.
Embryo-Fetal Toxicity: Meratinib can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
","Pediatric Use: The safety and efficacy of Neratinib in pediatric patients has not been established.
Geriatric Use: The incidence of serious adverse reactions in the Neratinib arm vs. placebo arm was 7.0% vs. 5.7% (<65 years-old) and 9.9% vs. 8.1% (≥65 years-old). The serious adverse reactions most frequently reported in the ≥ 65 years-old group were vomiting (2.3%), diarrhea (1.7%), renal failure (1.7%), and dehydration (1.2%).
Hepatic Impairment: No dose modifications are recommended for patients with mild to moderate hepatic impairment (Child Pugh A or B). Patients with severe, pre-existing hepatic impairment (Child Pugh Class C) experienced a reduction in Neratinib clearance and an increase in Cmax and AUC. Neratinib dosage should be reduced for patients with severe hepatic impairment.
","There is no specific antidote, and the benefit of hemodialysis in the treatment of Neratinib overdose is unknown. In the event of an overdose, administration should be withheld and general supportive measures undertaken. In the clinical trial setting, a limited number of patients reported overdose. The adverse reactions experienced by these patients were diarrhea, nausea, vomiting, and dehydration. The frequency and severity of gastrointestinal disorders (diarrhea, abdominal pain, nausea and vomiting) appear to be dose related.
",,,"Store below 30°C in a cool and dry place, away from sunlight. Keep out of reach of children.
",12
+804,Nepafenac,nepafenac-804,https://medex.com.bd/attachments/RE0VkaOESKQSauuYmnS92Ixjzh5FC2/nepafenac-01-ophthalmic-suspension-prescribing-information,Ophthalmic Non-Steroid drugs,Ocular inflammation,"Nepafenac 0.1% Sterile Ophthalmic Suspension: The treatment of post-operative ocular pain and inflammation including cataract surgery Inhibition of surgery induced miosis and Prevention of post-operative cystoid macular edema (CME).
Nepafenac 0.3% Sterile Ophthalmic Suspension: Post-operative pain and inflammation associated with cataract surgery.
","Ophthalmic Non-Steroid drugs
","Nepafenac is a nonsteroidal anti-inflammatory prodrug (NSAID). After instillation in the eye, it penetrates the cornea and is converted by ocular tissue hydrolase to Amfenac, a potent nonsteroidal anti-inflammatory drug. Amfenac is thought to inhibit the action of cyclooxygenase enzyme. This enzyme is required for prostaglandin synthesis.
","Nepafenac 0.1% Sterile Ophthalmic Suspension-
+
+- For post-operative pain & inflammation: Instill 1 drop 3 times daily 1 day prior to cataract surgery and continued on the day of surgery and through the first 2 weeks of the post-operative period.
+- For surgery induced miosis: Instill 1 drop 3 times daily 1 day before surgery & on the day of surgery.
+- For prevention of post-operative CME: Instill 1 drop 3 times daily 1 day before surgery and continued on the day of surgery and through the first 6 weeks of the post-operative period.
+
+Nepafenac 0.3% Sterile Ophthalmic Suspension-
+
+- For post-operative pain & inflammation: Instill 1 drop once daily 1 day prior to cataract surgery and continued on the day of surgery and through the first 2 weeks of the post-operative period. An additional drop should be administered 30 to 120 minutes prior to surgery.
+
",,,"Contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation or to other NSAIDs.
","Reported side effects are foreign body sensation, lid margin crusting, ocular discomfort, ocular hyperemia etc.
","Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Nepafenac should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether this drug is excreted in human milk. So, caution should be exercised when Nepafenac ophthalmic suspension is administered to a nursing mother.
","Nepafenac should be used with caution in patients with known bleeding tendencies or who are receiving medications which may prolong bleeding time.
","Use in children: Safety and effectiveness in pediatric patients below 18 years of age have not been established.
Use in elderly patients: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
",,,,,9
+803,Neostigmine Methyl Sulphate,neostigmine-methyl-sulphate-803,https://medex.com.bd/attachments/xcE96naC8bct4S0Z3HDf55R5OpfjIG/neostigmine-methyl-sulphate-prescribing-information,Anti-cholinesterases,Reversal of neuromuscular blockade,"Neostigmine Methyl Sulphate is indicated for-
+
+- Reversal of nondepolarising neuromuscular blockade for surgical anesthetic procedures
+- The prevention and treatment of post-operative abdominal distention and urinary retention after mechanical obstruction has been excluded.
... Read more
Neostigmine Methyl Sulphate is indicated for-
+
+- Reversal of nondepolarising neuromuscular blockade for surgical anesthetic procedures
+- The prevention and treatment of post-operative abdominal distention and urinary retention after mechanical obstruction has been excluded.
+- Treatment of the systemic control of Myasthenia Gravis when oral therapy is impractical.
+
","Anti-cholinesterases, Drugs used in Myasthenia Gravis
","Neostigmine is a parasympathomimetic, specifically, a reversible cholinesterase inhibitor. By interfering with the breakdown of acetylcholine, Neostigmine indirectly stimulates both nicotinic and muscarinic receptors. It does cross the blood-brain barrier but only poorly. Neostigmine binds to the anionic site of cholinesterase. The drug blocks the active site of acetylcholinesterase; so the enzyme can no longer break down the acetylcholine molecules before they reach the postsynaptic membrane receptors. This allows for the threshold to be reached so a new impulse can be triggered in the next neuron. In myasthenia gravis there are too few acetylcholine receptors. So with the acetylcholinesterase blocked, acetylcholine can bind to the few receptors and trigger a muscular contraction.
","Reversal of the effects of Non-depolarizing Neurormuscular Blocking Agents: The usual dose is 0.5 to 2 mg given by slow intravenous injection over 60 seconds; repeated as required. Total dose should not exceed 5 mg (in exceptional cases). When Neostigmine is administered intravenously, it is recommended that Atropine Sulphate (0.6-1.2 mg) also be given intravenously using separate syringe.
Prevention of post-operative abdominal distention and urinary retention: 0.25 mg intramuscularly or subcutaneously as soon as possible after operation; repeat every 4 6 hours for 2-3 days.
Treatment of post-operative abdominal distention: 0.5 mg intramuscularly or subcutaneously or as required.
Treatment of urinary retention: 0.5 mg intramuscularly or subcutaneously. If urination does not occur within an hour, the patient should be catheterized. After the patient has voided, or the bladder has been emptied, continue the 0.5 mg injection every 3 hours, for at least 5 injections.
Symptomatic control of Myasthenia Gravis: 0.5 mg intramuscularly or subcutaneously. Subsequent dose should be based on the individual patient's response.
Neonates: 50-250 micrograms (0.1 to 0.5 ml) every 4 hours.
Children: 200-500 micrograms (0.4 ml to 1 ml) as recommended.
",,"Anti-arrhythmic Procainamide, Quinidine and possibly Propafenone antagonise effect of Neostigmine. Antibacterials, Aminoglycosides, Clindamycin, Lincomycin and Polymyxins antagonise effect of Neostigmine.
","Neostigmine is contraindicated in patients with known hypersensitivity to the drug. It is also contraindicated in patients with peritonitis or mechanical obstruction of the intestinal or urinary tract.
","Nausea, vomiting, increased salivation, diarrhoea and abdominal cramps (more marked with high doses). Signs of overdose are increased gastrointestinal discomfort, bronchial secretions and sweating, involuntary defecation and micturition, miosis, nystagmus, bradycardia, hypotension, agitation, excessive dreaming and weakness eventually leading to fasciculation and paralysis.
","Pregnancy Category C. There are no adequate or well-controlled studies of Neostigmine in either laboratory animals or in pregnantwomen. It is not known whether Neostigmine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Neostigmine should be given to a pregnant woman only if clearly needed.
Nonteratogenic Effects: Anticholinesterase drugs may cause uterine irritability and induce premature labor when given intravenously to pregnant women near term.
Nursing Mothers: It is not known whether Neostigmine is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from Neostigmine in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","Asthma, bradycardia, recent myocardial infarction, epilepsy, hypotension, parkinsonism, vagotonia, peptic ulceration. Atropine or other antidote to muscarinic effccts may be necessary (particularly when Neostigmine is given by injection), but it should not be given routinely as it may mask signs of overdose.
",,,,,"Store in a cool and dry place, protected from light.
",10
+802,Neomycin Sulphate + Polymyxin B Sulphate + Pramoxine,neomycin-sulphate-polymyxin-b-sulphate-pramoxine-802,,Anti-infective & Anesthetic combined preparations,Minor burns,"This is a first aid cream. It prevents infections and provides temporary relief of pain or discomfort in minor cuts, scrapes and burns.
","Anti-infective & Anesthetic combined preparations
","This cream is a combination of Neomycin, Polymyxin B and Pramoxine HCl. Neomycin is bactericidal for many gram-positive and gram-negative organisms. It is an aminoglycoside antibiotic that inhibits protein synthesis by binding with ribosomal RNA and causing misreading of the bacterial genetic code. Polymyxin B is bactericidal for a variety of gram-negative organisms. It increases the permeability of the bacterial cell membrane by interacting with the phospholipids components of the membrane. Pramoxine is an external analgesic that provides temporary relief of pain or discomfort.
","Clean the affected area. Apply a small amount of product (an amount equal to the surface area of the tip of a finger). May be covered with a sterile bandage. Safety and effectiveness in children below 2 years of age have not been established.
",,,"Neomycin, Polymyxin B and Pramoxine HCl cream should not be administered to individuals who are hypersensitive to Neomycin, Polymyxin B, Pramoxine or any other components of this product.
","Topical antibiotics, particularly Neomycin sulphate, may cause cutaneous sensitization. The manifestations of sensitization to topical antibiotics are usually itching and reddening. When used in small doses, no common side effects have been reported with this product.
","Use Neomycin, Polymyxin B and Pramoxine HCl during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in breast milk. Exercise caution when applying Nepranol to a nursing mother.
","Do not use this medication in the eyes or apply to large areas of the body. Do not use longer than one week unless directed by the physician.
",,,,,"Store in a dry and cool place protected from light and moisture
",9
+1243,Neomycin Sulfate + Bacitracin Zinc + Polymyxin B Sulfate (Ophthalmic),neomycin-sulfate-bacitracin-zinc-polymyxin-b-sulfate-ophthalmic-1243,https://medex.com.bd/attachments/wQohce1IH4h7zMFJ2WzujuLr6JmsN4/neomycin-sulfate-bacitracin-zinc-polymyxin-b-sulfate-ophthalmic-prescribing-information,Aural Anti-bacterial preparations,Bacterial ear infections,"This ophthalmic ointment or drop is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.
","Aural Anti-bacterial preparations, Ophthalmic antibacterial drugs
","Neomycin, an aminoglyoside with antimicrobial spectrum similar to gentamicin, binds to the 30S subunits of the bacterial ribosome, inhibiting protein synthesis and thereby disrupting DNA synthesis. It is active against many gram-negative aerobes and against some strains of staphylococci.
Bacitracin, on the other hand, inhibits bacterial cell wall synthesis and is active against many gram-positive bacteria (e.g. staphylococci, streptococci, corynebacteria and Clostridia) and some gram-negative species (e.g. Neisseria and Haemophilus influenzae). They are often found in combinations in topical preparations as broad spectrum antibacterial agents.
Polymyxin B disrupts the bacterial cytoplasmic membrane of mostly gm-ve organisms allowing leakage of intracellular constituents by binding to membrane phospholipids.
","Eye Drop: 1-2 drops 3-4 times daily.
Eye ointment: Apply 1/2 inch ribbon of ointment to conjunctival sac of affected eye(s) q3-4hr for 7-10 days for acute infections
",,,"Hypersensitivity
","Rash, itching, burning, anaphylactic reactions, swelling, conjunctival erythema.
","Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Lactation: Excretion in breast milk unknown; caution should be taken
","Excessive use of the topical preparation may lead to substantial systemic absorption which may lead to nephrotoxicity (polymyxin B sulfate) and neurotoxicity (bacitracin). Prolonged use of the antibacterial preparation may cause overgrowth of non-susceptible organisms, including fungi. Pregnancy and lactation.
","Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
",,,,,9
+102,Neomycin Sulfate + Bacitracin Zinc + Polymyxin B Sulfate,neomycin-sulfate-bacitracin-zinc-polymyxin-b-sulfate-102,https://medex.com.bd/attachments/wNmRMuog5DsmyXGtHsN09mIpmwBXvx/neomycin-sulfate-bacitracin-zinc-polymyxin-b-sulfate-prescribing-information,Topical Antibiotic preparations,Scrapes,"This Ointment may be usedin the treatment of infected wounds, burns or skin grafts,andit is also of value in the preparation of donor sites for skin grafting and in the prevention of infection of extensive burnsand contaminated wounds. It is of value in the local treatment of chronic varicose or other ... Read more
This Ointment may be usedin the treatment of infected wounds, burns or skin grafts,andit is also of value in the preparation of donor sites for skin grafting and in the prevention of infection of extensive burnsand contaminated wounds. It is of value in the local treatment of chronic varicose or other indolent ulcers. The preparation is also of value, in the treatment of furuncles, carbuncles, pyoderma, sycosis barbae, impetigo and acne. It has also been used in dealing with secondary infected skin lesions of scabies, pediculosis, tinea pedis and contact and allergic dermatitis.
","Topical Antibiotic preparations
","The combination of Polymyxin B sulfate with Neomycin and Bacitracin zinc most nearly meets the criteria for an ideal topical antibacterial preparation. The spectrum of action encompasses virtually all pathogenic bacteria found topically and the three antibiotics are bactericidal. When used topically Polymyxin B sulphate with Neomycin and Bacitracin zinc are rarely irritating, and absorption from the skin or mucous membrane is insignificant. Polymyxin B sulphate attacks gram-negative bacilli including clinically isolated strains of Pseudomonas aeruginosa. This organism is conspicuously absent from the spectra of most other antibiotic agents, but it is highly susceptible to polymyxin B sulphate, which is acknowledged to be the most effective agent known for the treatment and prophylaxis of Pseudomonas infections. Neomycin provides bactericidal action against various gram-positive organisms and gram-negative organisms including many strains of Proteus. Neomycin is considered by various authorities to be the most effective antibiotic against Staphylococcus aureus which is among the more common aetiological organisms in topical bacterial infections. Bacitracin zinc is highly active against gram-positive bacilli and cocci and extends the spectrum to include haemolytic streptococci, thus completing the anti-bacterial range of this Ointment. There is overlapping of the bactericidal spectra of these three antibiotics, thereby providing increased activity through combined antibiotic action.
","Adult: This Ointment should be applied thinly over the affected area after cleaning it.1-3 daily applications should be continued until the infection is controlled and healing completely.
Children and Infants: This Ointment is suitable for use in children at the same dose as adults, but the dose should be reduced in infants. This ointment is not recommended for use in neonates.
",,,"This ointment should not be used in individuals who have shown sensitivity to any of the components. A possibility of increased absorption exists in very young children, thus this ointment is not recommended for use in neonates.
","Common side effects are Nausea; Vomiting; Pain, burning, or swelling; Skin rashes; Possible kidney problems; Hearing loss; Dizziness; Unusual numbness of the skin; Muscle twitching; Seizures; Pain; Redness; Swelling at the injection site.
","There is little information to demonstrate the possible effect of topically applied neomycin in pregnancy and lactation. However, neomycin present in maternal blood can cross the placenta and may give rise to a theoretical risk of foetal toxicity, thus this ointment is not recommended in pregnancy and lactation.
","It is to be noted that this Ointment is not intended for sterile use in surgical procedures such as those involving abdominal or thoracic cavities as there is evidence that neomycin, when in contact with peritoneal or pleural tissues, can potentiate neuromuscular block in patients under the influence of muscle relaxants, producing respiratory paralysis. As with other antibiotic preparations prolonged use may result in overgrowth of non-susceptible organisms. Ototoxicity to neomycin has been reported. In neonates and infants, absorption by immature skin may be enhanced and renal function may be immature.
",,,,,"Store below 30˚C. Keep all medicine out of reach of children.
",9
+103,Neomycin Sulfate + Bacitracin Zinc,neomycin-sulfate-bacitracin-zinc-103,,Ophthalmic and Topical antibacterial products,Superficial skin infections,"This is indicated in the treatment of topical bacterial infections. This is particularly effective in atopic, contact stasis and infections, eczematoid dermatitis, neurodermatitis, eczema, anogenital pruritus. It may also be useful as an adjunct in certain pyodermas, such as impetigo, during specific systemic antibiotic therapy for these infections.
","Ophthalmic and Topical antibacterial products
","Bacitracin inhibits bacterial cell wall synthesis and is active against many gram-positive bacteria (e.g. staphylococci, streptococci, corynebacteria and Clostridia) and some gram-negative species (e.g. Neisseria and Haemophilus influenzae). They are often found in combinations in topical preparations as broad spectrum antibacterial agents.
Neomycin, an aminoglyoside with antimicrobial spectrum similar to gentamicin, binds to the 30S subunits of the bacterial ribosome, inhibiting protein synthesis and thereby disrupting DNA synthesis. It is active against many gram negative aerobes and against some strains of staphylococci.
","Ointment: Before use, the area for application should be cleaned gently. Derbis such as pus or crusts should be removed from the affected area. Apply two to three times daily to the affected skin area.
Dusting Powder: Antibiotic powder is a non- sterile dusting powder and used for superficial skin infections. A light dusting of the powder to be applied to the affected skin area upto 4 times daily.
",,"Bacitracin Zinc: Increased risk of nephrotoxicity when used with other nephrotoxic drugs. May enhance the action of neuromuscular-blocking agents.
Neomycin Sulphate: Additive nephrotoxic and neurotoxic effect with other aminoglycosides, bacitracin, cisplatin, vancomycin, amphotericin B, polymyxin B, colistin and viomycin. Enhanced toxicity with potent diuretics. May impair the absorption of other drugs. May enhance the effect of acarbose. May enhance the effect of non-depolarising muscle relaxants. May antagonise the parasympathomimetic effect of neostigmine and pyridostigmine. May increase the risk of hypocalcaemia in patients receiving bisphosphonates. May alter INR when givenwithanticoagulants. May inactivate oral typhoid vaccine.
","Hypersensitivity to any of its components.
","This preparation is usually well tolerated. In rare cases, allergic reactions may be occurred.
","The safe use of this preparation during pregnancy & lactation has not been established. Therefore it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
","Bacitracin & Neomycin antibiotic powder should not be used to large open wounds or to severely injured skin or on areas that exude large volumes of fluid as hard crusts may form. Since this skin ointment contains Neomycin, it should not be used for the treatment of otitis external when the eardrum is perforated because of risk of ototoxicity.
Patients considering self-medication with a topical anti-infective for deep or puncture wounds, animal bites, or serious burns should be advised to first consult a physician. Patients using the preparations for the prevention of infection in minor skin injuries (e.g., cuts, scrapes, burns) should be advised to discontinue the topical anti-infective preparation and consult a physician if the condition persists or worsens; it should not be used for longer than 1 week unless directed by a physician.
","Children and Infants: This ointment is suitable for use in children at the same dose as adults, but the dose should be reduced in infants. This ointment is not recommended for use in neonates.
",,,,"Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.
",11
+1458,Obeticholic Acid,obeticholic-acid-1458,https://medex.com.bd/attachments/odFSI8pupYPUihhtNSajGSCj1KhIal/obeticholic-acid-prescribing-information,Farnesoid X Receptor Agonists,Primary biliary cholangitis (PBC),"Obeticholic Acid is indicated for the treatment of primary biliary cholangitis (PBC) in combination with Ursodeoxycholic Acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA, cholestatic liver disease & non-alcoholic fatty liver disease (NAFLD) including non-alcoholic steatohepatitis (NASH).
","Farnesoid X Receptor Agonists
","Obeticholic Acid is an agonist for FXR, a nuclear receptor expressed in the liver and intestine. FXR is a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways. FXR activation decreases the intracellular hepatocyte concentrations of bile acids by suppressing de novo synthesis from cholesterol as well as by increased transport of bile acids out of the hepatocytes. These mechanisms limit the overall size of the circulating bile acid pool while promoting choleresis, thus reducing hepatic exposure to bile acids.
","Starting Dosage: The recommended starting dosage of Obeticholic Acid is 5 mg orally once daily in adult patients who have not achieved an adequate biochemical response to an appropriate dosage of Ursodeoxycholic Acid (UDCA) for at least 1 year or are intolerant to UDCA.
Dosage Titration: If an adequate reduction in alkaline phosphatase (ALP) and/or total bilirubin has not been achieved after 3 months of Obeticholic Acid 5 mg once daily, and the patient is tolerating Obeticholic Acid, increase the dosage of Obeticholic Acid to 10 mg once daily.
Maximum Dosage: The maximum recommended dosage of Obeticholic Acid is 10 mg once daily.
Management of Patients with Intolerable Pruritus on Obeticholic Acid: For patients with intolerable pruritus on Obeticholic Acid, consider one or more of the following:
Add an antihistamine or bile acid binding resin. Reduce the dosage of Obeticholic Acid to:
+
+- 5 mg every other day, for patients intolerant to 5 mg once daily
+- 5 mg once daily, for patients intolerant to 10 mg once daily
+
+Temporarily interrupt Obeticholic Acid dosing for up to 2 weeks followed by restarting at a reduced dosage
Increase the dosage of Obeticholic Acid to 10 mg once daily, as tolerated, to achieve optimal response. Consider discontinuing Obeticholic Acid treatment in patients who continue to experience persistent, intolerable pruritus.
",,"Bile Acid Binding Resins: Bile acid binding resins such as cholestyramine, colestipol, or colesevelam adsorb and reduce bile acid absorption and may reduce the absorption, systemic exposure, and efficacy of Obeticholic Acid. If taking a bile acid binding resin, take Obeticholic Acid at least 4 hours before or 4 hours after taking the bile acid binding resin, or at as great an interval as possible.
Warfarin: The International Normalized Ratio (INR) decreased following co-administration of warfarin and Obeticholic Acid. Monitor INR and adjust the dosage of warfarin, as needed, to maintain the target INR range when co-administering Obeticholic Acid and warfarin.
CYP1A2 Substrates with Narrow Therapeutic Index: Obeticholic Acid may increase the exposure to concomitant drugs that are CYP1A2 substrates. Therapeutic monitoring of CYP1A2 substrates with a narrow therapeutic index.
","Contraindicated in patients known to have hypersensitivity to the drug or any of its components & in patients with complete biliary obstruction.
","The most common side effects of Obeticholic Acid include: Pruritus, Fatigue & Stomach pain and discomfort. Other common side effects include rash, arthralgia (joint pain), oropharyngeal pain (pain in the middle part of the throat), dizziness, constipation, abnormal thyroid function, and eczema (inflammation of the skin).
","The limited available human data on the use of Obeticholic Acid during pregnancy are not sufficient to inform a drug-associated risk.There is no information on the presence of Obeticholic Acid in human milk, the effects on the breast-fed infant or the effects on milk production.
","The following clinically significant reactions are described:
+
+- Liver-Related Adverse Reactions
+- Severe Pruritus
+- Reduction in high density lipoprotein-cholesterol (HDL-C)
+
+Special monitoring is essential for the patient with such type of problems
","Geriatric Use: No dosage adjustment is recommended in elderly patientless than 65 years of age.
Pediatric Use: Safety and efficacy have not been established in patients younger than 18 years.
Use in Patients with Impaired Renal Function: Obeticholic Acid has not been studied in patients with moderate and severe renal impairment (estimated glomerular filtration rate [eGFR] less than 60 ml/min/1.73 m2). In the population pharmacokinetic analysis, an eGFR greater than 50 ml/min/1.73 m2 did not have a meaningful effect on the pharmacokinetics of Obeticholic Acid and its conjugated metabolites.
Use in Patients with Impaired Hepatic Function: Obeticholic Acid is metabolized in the liver. Plasma exposure to Obeticholic Acid and its active conjugates, increases significantly in patients with moderate to severe hepatic impairment (Child-Pugh Classes B and C).The recommended starting dosage of Obeticholic Acid for moderate (Child-Pugh Class B) and severe (Child-Pugh Class C) hepatic impairment is 5 mg once weekly. If an adequate reduction in ALP and/or total bilirubin has not been achieved after 3 months of Obeticholic Acid 5 mg once weekly, and the patient is tolerating the drug, increase the dosage of Obeticholic Acid to 5 mg twice weekly (at least three days apart) and subsequently to 10 mg twice weekly (at least three days apart) depending on response and tolerability.
","In PBC patients who received Obeticholic Acid 25 mg once daily (2.5 times the highestrecommended dosage) or 50 mg once daily (5 times the highest recommended dosage), a dose-dependent increase in the incidence of liver-related adverse reactions, including elevations in liver biochemical tests, ascites, jaundice, portal hypertension, and primary biliary cholangitis flare, was reported. In the case of over dosage, patients should be carefully observed and supportive care administered, as appropriate.
",,,"Store at 15°C to 30°C in a dry place protected from light. Keep out of reach of children
",12
+1332,Nystatin (Topical),nystatin-topical-1332,https://medex.com.bd/attachments/EaNFwvKde0KDM4D9XATXJOiibNBgcg/nystatin-topical-prescribing-information,Drugs for subcutaneous and mycoses,Cutaneous or mucocutaneous mycotic infections,"Nystatin Cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.
","Drugs for subcutaneous and mycoses, Drugs used in Vaginal and Vulval condition
","Nystatin has fungistatic or fungicidal activity against variety of pathogenic and nonpathogenic yeast and fungi, including Candida albicans. Nystatin exerts its antifungal activity by binding to sterols in the fungal cell membrane. As a result of binding, the membrane is no longer able to function as a selective barrier, and potassium and other cellular constituents are lost. It is poorly absorbed from the gastrointestinal tract.
","Adults and Pediatric Patients (Neonates and Older): Apply liberally to affected areas twice daily or as indicated until healing is complete.
Pediatric Use: Safety and effectiveness have been established in the pediatric population from birth to 16 years.
Geriatric Use: Clinical studies with nystatin cream did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
",,,"Nystatin cream is contraindicated in patients with a history of hypersensitivity to any of its components.
","The frequency of adverse events reported in patients using nystatin cream is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application.
","Pregnancy Category C. Animal reproduction studies have not been conducted with any nystatin cream. It also is not known whether this cream can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin cream should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.
Nursing Mothers: It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.
","Nystatin cream should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections. If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens.
",,,,,"Store at 20° to 25°C. Avoid freezing.
",9
+819,Nystatin (Oral),nystatin-oral-819,https://medex.com.bd/attachments/opwwW2u23eBmqwRKunpiJ40WyAMlru/nystatin-oral-oral-suspension-prescribing-information,Drugs for subcutaneous and mycoses,Candida albicans,"Nystatin is an antifungal antibiotic active against a wide range of yeasts and yeast like fungi including Candida albicans. It is used for the prevention and treatment of Candida infections of oral cavity, esophagus and intestinal tract. It provides effective prophylaxis against oral candidiasis in ... Read more
Nystatin is an antifungal antibiotic active against a wide range of yeasts and yeast like fungi including Candida albicans. It is used for the prevention and treatment of Candida infections of oral cavity, esophagus and intestinal tract. It provides effective prophylaxis against oral candidiasis in those born of mothers with vaginal candidiasis. It is used for the prophylaxis of Candida overgrowth during courses of broadspectrum antibiotics.
","Drugs for subcutaneous and mycoses, Drugs used in Vaginal and Vulval condition
","Nystatin is an antifungal antibiotic. Which has fungistatic or fungicidal activity against variety of pathogenic and nonpathogenic yeast and fungi, including Candida albicans. Nystatin exerts its antifungal activity by binding to sterols in the fungal cell membrane. As a result of binding, the membrane is no longer able to function as a selective barrier, and potassium and other cellular constituents are lost. It is poorly absorbed from the gastrointestinal tract.
","Children:
+
+- In intestinal and oral candidiasis (thrush): 1,00,000 units (1 ml) should be dropped into the mouth four times daily.The longer the suspension is kept in contact with the affected area in the mouth, before swallowing, the greater will be its effect.
+- For prophylaxis in the newborn: The suggested dose is 1,00,000 units (1 ml) once daily or as prescribed by the physician.
+
+Adult:
+
+- For the treatment of intestinal or esophageal candidiasis: 5,00,000 units (5 ml) by mouth 3 or 4 times daily. The dose may be doubled, if required.
+- For prophylaxis of intestinal candidiasis in adults: 10,00,000 units (10 ml) daily.
+- For prophylaxis to suppress the over growth of Candida albicans in patients receiving broad spectrum antibiotic therapy: 10,00,000 units (10 ml) daily.
+- For the treatment of dental sores and oral infection: 1,00,000 units (1 ml) suspension should be dropped into the mouth four times daily.
+
+Elderly: Older people with intestinal candidiasis who are unable to swallow tablets should be given 5,00,000 units (5 ml) suspension four times daily.
",,,"There is no known contraindication to the use of Nystatin.
","Nausea, vomiting and diarrhoea have occasionally been reported with high doses of Nystatin. No systemic effects or allergic reactions have been associated with its oral dose.
","Absorption of Nystatin from the gastrointestinal tract is negligible, therefore no special precautions apply in pregnancy.
","Absorption from the gastrointestinal tract is negligible, therefore no special precaution is required to apply in pregnancy and lactation.
",,,,,"Store in a cool and dry place, protect from light. Keep out of reach of children.
",9
+818,Nortriptyline,nortriptyline-818,https://medex.com.bd/attachments/ua9pWQ7IFRxfoYHjzXO1EjntTGQrG7/nortriptyline-capsules-oral-solution-prescribing-information,Tricyclic & related anti-depressant drugs,Trichotillomania,"Nortriptyline is indicated for the treatment of depression and nocturnal enuresis.
","Tricyclic & related anti-depressant drugs, Tricyclic Anti-depressant
","Nortriptyline, a dibenzocycloheptadiene tricyclic antidepressant, is the primary active metabolite of amitriptyline. It increases synaptic concentration of serotonin and/or norepinephrine in the CNS by blocking the neuronal reuptake of norepinephrine and serotonin.
","Depression:
+
+- Adult: Low dose initially increased as necessary to 75-100 mg daily in divided doses or as a single dose (max. 150 mg daily)
+- Adolescent & Elderly: 30-50 mg daily in divided doses; Child not recommended for depression
+
+Nocturnal enuresis:
+
+- Child 7 years: 10 mg
+- 8-11 years: 10-20 mg
+- Over 11 years: 25-35 mg, 30 minutes before bedtime; max period of treatment (including gradual withdrawal) 3 months- full physical examination and ECG before further course.
+
",,"Nortriptyline should not be given with adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine, phenylpropanolamine, drugs that are metabolized by CYP4502D6, MAOIs, guanethidine, debrisoquine, bethanidine, clonidine and reserpine etc. Barbiturates may increase the rate of metabolism of nortriptyline.
","Nortriptyline is contraindicated in patients with hypersensitivity to nortriptyline. Concomitant administration with MAOI is contraindicated. Do not use with or within 2 weeks of stopping an MAOI. Nortriptyline is contraindicated during the acute recovery period after myocardial infarction.
","The most common side effects include dry mouth, sedation, constipation and increased appetite, mild blurred vision, tinnitus, often euphoria and mania. An occasional side effect is a rapid or irregular heartbeat. Alcohol may exacerbate some of its side effects and should be avoided.
","The safety of nortriptyline for use in pregnancy has not been established. Nortriptyline should only be given during pregnancy when there are no alternatives and benefit outweighs risk.
","Not intended for treatment of bipolar depression. Avoid abrupt withdrawal. Patient at risk of seizures, with DM, narrow angle glaucoma, urinary retention, prostatic hyperplasia, chronic constipation, history of CV disease. Renal and hepatic impairment. Elderly, childn. Pregnancy and lactation.
",,"Symptoms: Severe hypotension, cardiac dysrhythmias, shock, CHF, pulmonary oedema, convulsions, and CNS depression, including coma; changes in ECG.
Management: Symptomatic and supportive treatment. Admin IV Na bicarbonate, benzodiazepines. Admin activated charcoal to reduce absorption. Emesis is contraindicated. Initiate cardiac monitoring and observe for signs of CNS or resp depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures.
",,,"Store at 15-30° C. Protect from light and moisture.
",11
+440,Norgestrel + Ethinyl Estradiol + Ferrous Fumarate,norgestrel-ethinyl-estradiol-ferrous-fumarate-440,https://medex.com.bd/attachments/0idcpIjeDxE9iH1fyZ3uQVX2VGAGrH/norgestrel-ethinyl-estradiol-ferrous-fumarate-prescribing-information,Oral Contraceptive preparations,Oral contraceptives,"Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
","Oral Contraceptive preparations
","Combination oral contraceptives (COC) act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).
","To achieve maximum contraceptive effectiveness, Norgestrel & Ethinyl Estradiol and ferrous fumarate must be taken exactly as directed and at intervals not exceeding 24 hours. The possibility of ovulation and conception prior to initiation of medication should be considered. The dosage of Norgestrel & Ethinyl Estradiol and ferrous fumarate is one white tablet daily for 21 consecutive days, followed by one brown tablet daily for 7 consecutive days, according to prescribed schedule. It is recommended that tablets be taken at the same time each day.
",,"Reduced contraceptive effectiveness with antibiotics, anticonvulsants and drugs that may increase contraceptive steroids clearance (e.g. bosentan, rifampicin, rifabutin, barbiturates, primidone, phenytoin, carbamazepine, oxcarbazepine, topiramate, griseofulvin, aprepitant). Severe pruritus and jaundice with troleandomycin, avoid concurrent use. Decreased effectiveness of ursodeoxycholic acid by increasing the elimination of cholesterol in bile. Effects of danazol or gestrinone and hormonal contraceptives might be altered or reduced by concurrent use, avoid concomittant use.
Decreased contraceptive effectiveness with anti-HIV protease inhibitors. Increased tacrolimus levels with ethinyl estradiol. May increase theophylline, selegiline and tizanidine levels with oral contraceptives.
","Pregnancy, undiagnosed vaginal bleeding, severe arterial disease (or family history of atherogenic lipid profile); liver adenoma; porphyria; after evacuation of hydatidiform mole; history of breast cancer; hepatic impairment; thrombophloebitis or thromboembolic disorders; breast carcinoma except in selected patients being treated for metastatic disease; oestrogen-dependent tumour; smoking >40 cigarettes daily; >50 yr; diabetes complications present; BMI >39 kg/m2; migraine with typical focal aura, lasting >72 hr despite treatment or migraine treated with ergot derivatives; BP >160 mmHg systolic and 100 mmHg diastolic; transient ischaemic attacks without headaches; SLE; gallstones; history of haemolytic uraemic syndrome, pruritis during pregnancy; cholestatic jaundice; chorea or deterioration of otosclerosis pemphigoid; breast feeding during 1 st 6 mth after delivery.
","Edema, Weakness, Amenorrhea, Breakthrough bleeding, Change in menstrual flow, Spotting, Anorexia, DVT, Thrombophlebitis, Depression, Dizziness, Headache, Nervousness, Somnolence, B reast tenderness, Galactorrhea, Abdominal pain, Nausea, Vomiting, Change in weight, Cholestatic jaundice
","Extensive epidemiological studies have revealed no increased risk of birth defects in infants born to women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly insofar as cardiac anomalies and limb-reduction defects are concerned, when taken inadvertently during early pregnancy
The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. Oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion.
It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing oral-contraceptive use. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period. Oral-contraceptive use should be discontinued if pregnancy is confirmed.
","Sex-steroid dependent cancer; past ectopic pregnancy; malabsorption syndromes; functional ovarian cysts; active liver disease, recurrent cholestatic jaundice, history of jaundice in pregnancy; history of CV or renal impairment; DM; asthma; epilepsy; migraine; depression; lactation; conditions exacerbated by fluid retention; hypercalcaemia; CV and gall bladder diseases; lipid effects; familial defects of lipoprotein metabolism; patients at risk of venous thromboembolism, breast cancer, preexisting uterine leiomyomata and benign hepatic adenoma; family history of arterial disease in 1 st degree relative systolic 140 mmHg and diastolic 90 mmHg; >35 yr; BMI 30-39 kg/m2; migraine without focal aura, controlled with 5HT1; Gl upset (vomiting and diarrhoea), missed pills and interaction with other drugs may require additional contraceptive precautions. Should be taken at same time each day.
Lactation: small amounts of steroids are excreted in breast milk; estrogens may reduce quality/quantity of milk; may be prudent to use other forms of birth control until full weaning
",,,,,,9
+1806,Norgestrel,norgestrel-1806,https://medex.com.bd/attachments/CLKLExWZYEWtrY8SMKw80HUz2gYdac/norgestrel-prescribing-information,Oral Contraceptive preparations,Oral contraceptives,"Norgestrel tablets are indicated for use by females of reproductive potential to prevent pregnancy. This tablet are not for use as emergency contraception.
","Oral Contraceptive preparations
","Progestin-only oral contraceptives such as Norgestrel tablets prevent conception by suppres sing ovulation in approximately half of the cycles in users, thickening the cervical mucus to inhibit sperm penetration, lowering the midcycle LH and FSH peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium. Serum progestin levels peak about two hours after oral administration, followed by rapid distribution and elimination. By 24 hours after drug ingestion, serum levels are near baseline, making efficacy dependent upon rigid adherence to the dosing schedule. There are large variations in serum levels among individual users. Progestin-only administration results in lower steady-state progestin levels and a shorter elimination half-life than concomitant administration with estrogens.
","To achieve maximum contraceptive effectiveness, Norgestrel Tablets must be taken exactly as directed. The woman should take one tablet every day, at the same time. The administration is continuous, with no interruption between pill packs.
",,,"Norgestrel tablet is contraindicated for use by women who are known to have the following conditions:
+
+- Known or suspected pregnancy
+- Known or suspected carcinoma of the breast, or other progestin-sensitive cancer, now or in the past
+- Undiagnosed abnormal uterine bleeding
+- Hypersensitivity to any component of this product
+- Benign or malignant liver tumors
+
","An increased risk of the following adverse reactions has been reported with the use of progestin-only oral contraceptives: Delayed follicular atresia/ovarian cysts, Menstrual irregularity, changes in menstrual flow; breakthrough bleeding/spotting; amenorrhea, prolonged bleeding. The following adverse reactions were reported in ≥5% of subjects in the Norgestrel Tablet clinical studies:
+
+- Headache
+- Dizziness
+- Nausea
+- Increased appetite
+- Abdominal pain, cramps and bloating
+- Fatigue
+- Vaginal discharge
+- Dysmenorrhea
+- Nervousness
+- Backache
+- Breast discomfort
+- Acne
+
","Pregnancy: Norgestrel Tablets are contraindicated for use in pregnant women because there is no need for pregnancy prevention in a woman who is already pregnant. Published studies report no harmful effects on fetal development associated with long-term use of contraceptive doses of oral progestins in pregnant women. Discontinue Norgestrel Tablets if pregnancy is confirmed.
Nursing Mothers: Small amounts of progestin pass into the breast milk, resulting in steroid levels in infant plasma. No adverse effects have been reported on breastfeeding performance or infant health. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Norgestrel Tablets and any potential adverse effects on the breastfed infant from Norgestrel Tablets or from the underlying maternal condition.
","Migraine/Headache: The onset or exacerbation of migraine, or development of headache with a new pattern that is recurrent, persistent, or severe requires evaluation of the cause because women with migraine may be at increased risk of stroke.
Drug Interactions:
+
+- The effectiveness of progestin-only pills is reduced by hepatic enzyme-inducing drugs such as phenytoin, carbamazepine, barbiturates, rifampin, efavirenz, bosentan and herbal preparations containing St. John’s Wort (hypericum perforatum ). This could result in unintended pregnancy or breakthrough bleeding. During concomitant use of Norgestrel and substances that may affect its efficacy, it is recommended that a nonhormonal back-up method of contraception (such as condom) be used in addition to the regular intake of Norgestrel Tablets. Use of a nonhormonal back-up method is recommeded for 28 days after discontinuation of substances that have led to induction of hepatic microsomal enzymes. For women receiving long-term therapy with hepatic enzyme inducers, another method of contraception should be considered.
+- Effectiveness of progestin-containing hormonal contraceptives and emergency contraceptive ulipristal acetate may be decreased if progestin-containing hormonal contraceptives are used within five days after ulipristal acetate dosing. If a woman wishes to use Norgestrel Tablets after using ulipristal acetate, she should do so no sooner than 5 days after the intake of ulipristal acetate and she should use a reliable barrier method for subsequent acts of intercourse until her next menstrual period.
+
+
Gastrointestinal: Diarrhea and/or vomiting within 4 hours after taking a pill may reduce hormone absorption. Women should use of a nonhormonal back-up method of birth control (such as a condom or spermicide) during the next 48 hours.
Interactions with Laboratory Tests: The following endocrine tests may be affected by Norgestrel Tablets use:
+
+- Sex hormone-binding globulin (SHBG) concentrations may be decreased.
+- Total thyroxine concentrations may be decreased, due to a decrease in thyroid binding globulin (TBG). However, free thyroxine level should remain unchanged.
+
","Pediatric Use: The safety and efficacy of Norgestrel tablets have been established in women of reproductive age, including adolescents as young as 15 years of age, and almost 30% of subjects in the clinical trials who were under 20 years of age. Use of this product before menarche is not indicated.
Geriatric Use: Norgestrel tablet Tablets have not been studied in postmenopausal women and is not indicated in this population.
","Symptoms of oral contraceptive overdosage may include nausea, vomiting, breast tenderness, dizziness, somnolence ( drowsiness/fatigue), and withdrawal bleeding in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.
",,,"Store at controlled room temperature between 20° to 25°C.
",11
+817,Norethisterone Acetate,norethisterone-acetate-817,https://medex.com.bd/attachments/z1x90wunx8G2ww8UxnDPZfhIiecy7p/norethisterone-acetate-prescribing-information,Female Sex hormones,Premenstrual syndrome,"Norethisterone is indicated in:
+
+- Metropathia hemorrhagic (dysfunctional uterine bleeding),
+- Premenstrual syndrome,
+- Postponement of menstruation,
+- Endometriosis &
+- Menorrhagia.
+
","Drugs for menopausal symptoms: Hormone replacement therapy, Female Sex hormones, Oral Contraceptive preparations
","Norethisterone tablet is a preparation of Norethisterone which has progestational actions similar to those of progesterone, but is a more potent inhibitor of ovulation and has weak estrogenic and androgenic properties. It is used to treat a number of disorders of the menstrual cycle. Norethisterone is absorbed from the gastrointestinal tract and its effects last for at least 24 hours. It is excreted in the urine.
","Oral administration. Not intended for use in children.
Metropathia haemorrhagica (dysfunctional uterine bleeding): 1 tablet 3 times daily for 10 days. Bleeding is arrested usually within 1-3 days. A withdrawal bleeding resembling normal menstruation occurs within 2-4 days after discontinuing treatment.
Prophylaxis against recurrence of dysfunctional bleeding: If there are no signs of resumption of normal ovarian function (no rise in the second half of the cycle of the morning temperature, which should be measured daily) recurrence must be anticipated. Cyclical bleeding can be established with 1 tablet twice daily from the 19th to the 26th day of the cycle.
Premenstrual syndrome (including premenstrual mastalgia): Premenstrual symptoms such as headache, migraine, breast discomfort, water retention, tachycardia, and psychological disturbances may be relieved by the administration of 2-3 tablets daily from the 19th to the 26th day of the cycle. Treatment should be repeated for several cycles. When treatment is stopped, the patient may remain symptom-free for a number of months.
Postponement of menstruation: In cases of too frequent menstrual bleeding, and in special circumstances (e.g. operations, travel, sports) the postponement of menstruation is possible. 1 tablet of Norethisterone three times daily, starting 3 days before the expected onset of menstruation. A normal period should occur 2-3 days after the patient has stopped taking tablets.
Endometriosis (pseudo-pregnancy therapy): Long-term treatment is commenced on the 5th day of the cycle with 2 tablets of Norethisterone daily for the first few weeks. In the event of spotting, the dosage is increased to 4, and, if necessary, 5 tablets daily. After bleeding has ceased, the initial dose is usually sufficient. Duration of treatment: 4-6 months continuously, or longer if necessary.
Menorrhagia (hypermenorrhoea): 1 tablet 2-3 times a day from the 19th to the 26th day of the cycle (counting the first day of menstruation as day 1).
",,"Not known.
","
+- Pregnancy
+- Severe disturbances of liver function
+- Dubin-Johnson syndrome
+- Rotor syndrome
+- Previous or existing liver tumours
+- History during pregnancy of idiopathic jaundice, severe pruritus or herpes gestationis
+- Current thromboembolic processes
+- Hypersensitivity to the active substances or to any of the excipients
+
","Side-effects are more common during the first months after start of intake of Norethisterone, and subside with a duration of treatment. The side-effects are mentioned below:
+
+- Eye disorders- Visual disturbance
+- GI disorders- Nausea
+- General disorders and administration site- conditions headache, edema
+- Nervous system disorders- Migraine, Respiratory, thoracic and mediastinal disorders- Dyspnoea,
+- Skin and subcutaneous tissue disorders- Hypersensitivity (eg. Rash, urticaria).
+
","The administration of Norethisterone during pregnancy is contraindicated. Norethisterone should not be used during lactation.
","There is a general opinion, based on statistical evidence that users of combined oral contraceptives experience, more often than non-users, venous thromboembolism, arterial thrombosis, including cerebral and myocardial infarction and subarachnoid haemorrhage. Full recovery from such disorders does not always occur, and it should be realized that in a few cases they are fatal. Although Norethisterone does not contain oestrogen, one should keep the possibility of an increased thromboembolic risk in mind, particularly where there is a history of thromboembolic disease or in the presence of severe diabetes with vascular changes or sickle-cell anaemia.
In rare cases benign, and in even rarer cases, malignant liver tumours leading in isolated cases to life-threatening intra-abdominal haemorrhage have been observed after the use of hormonal substances such as the one contained in Norethisterone. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a liver tumour should be included in the differential diagnosis and, if necessary, the preparation should be withdrawn.
Norethisterone can influence carbohydrate metabolism. Parameters of carbohydrate metabolism should be examined carefully in all diabetics before and regularly during treatment.
Reasons for stopping Norethisterone immediately-
+
+- Occurrence for the first time of migrainous headaches or more frequent occurrence of unusually severe headaches
+- Sudden perceptual disorders (e.g. disturbances of vision or hearing)
+- First signs of thrombophlebitis or thromboembolic symptoms, feeling of pain and tightness in the chest
+- Pending operations (six weeks beforehand), immobilisation (e.g. after accidents)
+- Onset of jaundice, hepatitis, general pruritus
+- Significant rise in blood pressure
+- Pregnancy.
+
",,"There have been no reports from overdosage and treatment is generally unnecessary. There are no special antidotes and treatment should be symptomatic.
",,,"Store below 30°C in a cool & dry place. Keep out of reach of children.
",11
+816,Norepinephrine,norepinephrine-816,https://medex.com.bd/attachments/a9YSy1ZazSDJIOMZo3X2k9kuj4x694/norepinephrine-prescribing-information,Alpha and Beta-adrenergic agonist,Sepsis,"For blood pressure control in certain acute hypotensive states (e.g., pheochromocytomectomy, sympathectomy, poliomyelitis, spinal anesthesia, myocardial infarction, septicemia, blood transfusion, and drug reactions). As an adjunct in the treatment of cardiac arrest and profound hypotension.
","Alpha and Beta-adrenergic agonist
","Norepinephrine is a direct-acting sympathomimetic which stimulates β1- and α-adrenergic receptors. Its α-agonist effects cause vasoconstriction, thereby raising systolic and diastolic BP with reflex slowing of heart rate.
","An infusion of Norepinephrine should be given into a large vein. Restoration of Blood Pressure in Acute Hypotensive States. Blood volume depletion should always be corrected as fully as possible before any vasopressor is administered. When, as an emergency measure, intraaortic pressures must be maintained to prevent cerebral or coronary artery ischemia, Norepinephrine can be administered before and concurrently with blood volume replacement.
Diluent: Norepinephrine should be diluted in 5 percent dextrose injection or 5 percent dextrose and sodium chloride injections. These dextrose containing fluids are protection against significant loss of potency due to oxidation. Administration in saline solution alone is not recommended. Whole blood or plasma, if indicated to increase blood volume, should be administered separately (for example, by use of a Y-tube and individual containers if given simultaneously).
Average Dosage: Add the content of the ampoule (4 mg/4 ml) of Norepinephrine to 1,000 mL of a 5 percent dextrose containing solution. Each ml of this dilution contains 4 mcg of the base of Norepinephrine. Give this solution by intravenous infusion. Insert a plastic intravenous catheter through a suitable bore needle well advanced centrally into the vein and securely fixed with adhesive tape, avoiding, if possible, a catheter tie-in technique as this promotes stasis. An IV drip chamber or other suitable metering device is essential to permit an accurate estimation of the rate of flow in drops per minute. After observing the response to an initial dose of 2 ml to 3 ml (from 8 mcg to 12 mcg of base) per minute, adjust the rate of flow to establish and maintain a low normal blood pressure (usually 80 mm Hg to 100 mm Hg systolic) sufficient to maintain the circulation to vital organs. In previously hypertensive patients, it is recommended that the blood pressure should be raised no higher than 40 mm Hg below the preexisting systolic pressure. The average maintenance dose ranges from 0.5 ml to 1 ml per minute (from 2 mcg to 4 mcg of base).
High Dosage: In all cases, dosage of Norepinephrine should be titrated according to the response of the patient. Occasionally much larger or even enormous daily doses (as high as 68 mg base or 17 ampoules) may be necessary if the patient remains hypotensive, but occult blood volume depletion should always be suspected and corrected when present. Central venous pressure monitoring is usually helpful in detecting and treating this situation.
Fluid Intake: The degree of dilution depends on clinical fluid volume requirements. If large volumes of fluid (dextrose) are needed at a flow rate that would involve an excessive dose of the pressor agent per unit of time, a solution more dilute than 4 mcg per ml should be used. On the other hand, when large volumes of fluid are clinically undesirable, a concentration greater than 4 mcg per ml may be necessary.
Duration of Therapy: The infusion should be continued until adequate blood pressure and tissue perfusion are maintained without therapy. Infusions of Norepinephrine should be reduced gradually, avoiding abrupt withdrawal. In some of the reported cases of vascular collapse due to acute myocardial infarction, treatment was required for up to six days.
Adjunctive Treatment in Cardiac Arrest: Infusions of Norepinephrine are usually administered intravenously during cardiac resuscitation to restore and maintain an adequate blood pressure after an effective heartbeat and ventilation have been established by other means. Norepinephrine powerful beta-adrenergic stimulating action is also thought to increase the strength and effectiveness of systolic contractions once they occur.
Average Dosage: To maintain systemic blood pressure during the management of cardiac arrest, Norepinephrine is used in the same manner as described under Restoration of Blood Pressure in Acute Hypotensive States. Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate. Avoid contact with iron salts, alkalis, or oxidizing agents.
",,"Cyclopropane and halothane anesthetics increase cardiac autonomic irritability and therefore seem to sensitize the myocardium to the action of intravenously administered epinephrine or norepinephrine. Hence, the use of Norepinephrine during cyclopropane and halothane anesthesia is generally considered contraindicated because of the risk of producing ventricular tachycardia or fibrillation. The same type of cardiac arrhythmias may result from the use of Norepinephrine in patients with profound hypoxia or hypercarbia. Norepinephrine should be used with extreme caution in patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types, because severe, prolonged hypertension may result.
","Norepinephrine should not be given to patients who are hypotensive from blood volume deficits except as an emergency measure to maintain coronary and cerebral artery perfusion until blood volume replacement therapy can be completed. If Norepinephrine is continuously administered to maintain blood pressure in the absence of blood volume replacement, the following may occur: severe peripheral and visceral vasoconstriction, decreased renal perfusion and urine output, poor systemic blood flow despite “normal” blood pressure, tissue hypoxia, and lactate acidosis. Norepinephrine should also not be given to patients with mesenteric or peripheral vascular thrombosis (because of the risk of increasing ischemia and extending the area of infarction) unless, in the opinion of the attending physician, the administration of Norepinephrine is necessary as a life-saving procedure. Cyclopropane and halothane anesthetics increase cardiac autonomic irritability and therefore seem to sensitize the myocardium to the action of intravenously administered epinephrine or norepinephrine. Hence, the use of Norepinephrine during cyclopropane and halothane anesthesia is generally considered contraindicated because of the risk of producing ventricular tachycardia or fibrillation. The same type of cardiac arrhythmias may result from the use of Norepinephrine in patients with profound hypoxia or hypercarbia.
","Body as a whole: Ischemic injury due to potent vasoconstrictor action and tissue hypoxia.
Cardiovascular System: Bradycardia, probably as a reflex result of a rise in blood pressure, arrhythmias.
Nervous System: Anxiety, transient headache.
Respiratory System: Respiratory difficulty.
Skin and Appendages: Extravasation necrosis at injection site. Prolonged administration of any potent vasopressor may result in plasma volume depletion which should be continuously corrected by appropriate fluid and electrolyte replacement therapy. If plasma volumes are not corrected, hypotension may recur when Norepinephrine is discontinued, or blood pressure may be maintained at the risk of severe peripheral and visceral vasoconstriction (e.g., decreased renal perfusion) with diminution in blood flow and tissue perfusion with subsequent tissue hypoxia and lactic acidosis and possible ischemic injury. Gangrene of extremities has been rarely reported. Overdoses or conventional doses in hypersensitive persons (e.g., hyperthyroid patients) cause severe hypertension with violent headache, photophobia, stabbing retrosternal pain, pallor, intense sweating, and vomiting.
","Pregnancy Category C. Animal reproduction studies have not been conducted with Norepinephrine. It is also not known whether Norepinephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Norepinephrine should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Norepinephrine is administered to a nursing woman.
","Avoid Hypertension: Because of the potency of Norepinephrine and because of varying response to pressor substances, the possibility always exists that dangerously high blood pressure may be produced with overdoses of this pressor agent. It is desirable, therefore, to record the blood pressure every two minutes from the time administration is started until the desired blood pressure is obtained, then every five minutes if administration is to be continued. The rate of flow must be watched constantly, and the patient should never be left unattended while receiving Norepinephrine. Headache may be a symptom of hypertension due to overdosage.
Site of Infusion: Whenever possible, infusions of Norepinephrine should be given into a large vein, particularly an antecubital vein because, when administered into this vein, the risk of necrosis of the overlying skin from prolonged vasoconstriction is apparently very slight. Some authors have indicated that the femoral vein is also an acceptable route of administration. A catheter tie-in technique should be avoided, if possible, since the obstruction to blood flow around the tubing may cause stasis and increased local concentration of the drug. Occlusive vascular diseases (for example, atherosclerosis, arteriosclerosis, diabetic endarteritis, Buerger’s disease) are more likely to occur in the lower than in the upper extremity. Therefore, one should avoid the veins of the leg in elderly patients or in those suffering from such disorders. Gangrene has been reported in a lower extremity when infusions of Norepinephrine were given in an ankle vein.
Extravasation: The infusion site should be checked frequently for free flow. Care should be taken to avoid extravasation of Norepinephrine into the tissues, as local necrosis might ensue due to the vasoconstrictive action of the drug. Blanching along the course of the infused vein, sometimes without obvious extravasation, has been attributed to vasa vasorum constriction with increased permeability of the vein wall, permitting some leakage. This also may progress on rare occasions to superficial slough, particularly during infusion into leg veins in elderly patients or in those suffering from obliterative vascular disease. Hence, if blanching occurs, consideration should be given to the advisability of changing the infusion site at intervals to allow the effects of local vasoconstriction to subside.
Antidote for Extravasation Ischemia: To prevent sloughing and necrosis in areas in which extravasation has taken place, the area should be infiltrated as soon as possible with 10 mL to 15 mL of saline solution containing from 5 mg to 10 mg of phentolamine, an adrenergic blocking agent. A syringe with a fine hypodermic needle should be used, with the solution being infiltrated liberally throughout the area, which is easily identified by its cold, hard, and pallid appearance. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours. Therefore, phentolamine should be given as soon as possible after the extravasation is noted.
","Use in Children & Adolescents: Safety and effectiveness in pediatric patients has not been established.
Geriatric Use: Clinical studies of Norepinephrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Norepinephrine infusions should not be administered into the veins in the leg in elderly patients.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies have not been performed.
","Overdosage with Norepinephrine may result in headache, severe hypertension, reflex bradycardia, marked increase in peripheral resistance, and decreased cardiac output. In case of accidental overdosage, as evidenced by excessive blood pressure elevation, discontinue Norepinephrine until the condition of the patient stabilizes.
",,"Intravenous: Dilute with 5% glucose inj, with or without sodium chloride; dilution with sodium chloride inj alone is not recommended.
","Store at a temperature not exceeding 30°C in a dry place. Protect from light.
",13
+1271,Nizatidine,nizatidine-1271,https://medex.com.bd/attachments/imwUVcKunWpl6TflJed7lfXA27sBOu/nizatidine-prescribing-information,H2 receptor antagonist,Yellow fever infection,"Nizatidine is indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks.
Nizatidine is indicated for maintenance therapy for duodenalulcer patients, at a reduced dosage of 150 mg h.s. after healing ... Read more
Nizatidine is indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks.
Nizatidine is indicated for maintenance therapy for duodenalulcer patients, at a reduced dosage of 150 mg h.s. after healing of an active duodenal ulcer. The consequences of continuous therapy with Nizatidine for longer than 1 year are not known.
Nizatidine is indicated for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD.
Nizatidine is indicated for up to 8 weeks for the treatment of active benign gastric ulcer. Before initiating therapy, care should be taken to exclude the possibility of malignant gastric ulceration.
","H2 receptor antagonist
","Nizatidine is a competitive, reversible inhibitor of histamine at the histamine H2-receptors, particularly those in the gastric parietal cells. By inhibiting the action of histamine on stomach cells, nizatidine reduces stomach acid production. Nizatidine had no demonstrable antiandrogenic action. Full-dose therapy for the problems treated by nizatidine lasts no longer than 8 weeks. It has been demonstrated that treatment with a reduced dose of nizatidine is effective as maintenance therapy following healing of active duodenal ulcers.
","Active Duodenal Ulcer: The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.
Maintenance of Healed Duodenal Ulcer: The recommended oral dosage for adults is 150 mg once daily at bedtime.
Gastroesophageal Reflux Disease: The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150mg twice daily.
Active Benign Gastric Ulcer: The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.
",,"No interactions have been observed between Nizatidine and theophylline, chlordiazepoxide, lorazepam, lidocaine, phenytoin, and warfarin. Nizatidine does not inhibit the cytochrome P-450-linked drug-metabolizing enzyme system; therefore, drug interactions mediated by inhibition of hepatic metabolism are not expected to occur. In patients given very high doses (3,900 mg) of aspirin daily, increases in serum salicylate levels were seen when nizatidine, 150 mg b.i.d., was administered concurrently.
","Nizatidine is contraindicated in patients with known hypersensitivity to the drug. Because cross sensitivity in this class of compounds has been observed, H2-receptor antagonists, including Nizatidine , should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.
","Headache, dizziness, insomnia, abnormal dreams, somnolence, asthenia, anxiety, excessive sweating, diarrhoea, nausea and/or vomiting, abdominal pain/discomfort, constipation, flatulence, dyspepsia, dry mouth, anorexia, tooth disorder, urticaria, rash, pruritus, exfoliative dermatitis, anaemia, rhinitis, pharyngitis, sinusitis, reversible hepatocellular injury, diaphoresis, myalgia, fever. Rarely, asymptomatic ventricular tachycardia, thrombocytopenic purpura, decreased libido, gynaecomastia, reversible cholestatic or mixed cholestatic-hepatocellular injury with jaundice.
","Pregnancy Category B. Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
","Possibility of malignancy should be excluded prior to therapy as the drug may mask symptoms and delay diagnosis of gastric malignancy. Increased risk of community-acquired pneumonia. Renal impairment. Pregnancy and lactation.
","Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency-
Active Duodenal Ulcer, GERD and Benign Gastric Ulcer:
+
+- CrCl 20-50 ml/min: 150 mg daily
+- CrCl <20 ml/min: 150 mg every other day
+
+Maintenance Therapy:
+
+- CrCl 20-50 ml/min: 150 mg every other day
+- CrCl <20 mL/min: 150 mg every 3 days
+
+Some elderly patients may have creatinine clearances of less than 50 ml/min, and, based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.
","Symptoms: Lacrimation, salivation, emesis, miosis, and diarrhoea.
Management: Symptomatic and supportive treatment. Activated charcoal, emesis or lavage may reduce absorption.
",,,"Store at 25°C
",12
+1809,Nivolumab,nivolumab-1809,,Immunosuppressant,Melanoma,"Nivolumab is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of:
Melanoma:
+
+- patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab.
+- patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection, in the adjuvant setting.
... Read more
Nivolumab is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of:
Melanoma:
+
+- patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab.
+- patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection, in the adjuvant setting.
+
+
Non-Small Cell Lung Cancer (NSCLC):
+
+- adult patients with metastatic non-small cell lung cancer expressing PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab.
+- adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum doublet chemotherapy.
+- patients with metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Nivolumab.
+
+
Malignant Pleural Mesothelioma: adult patients with unresectable malignant pleural mesothelioma, as first-line treatment in combination with ipilimumab.
Renal Cell Carcinoma (RCC):
+
+- patients with intermediate or poor risk advanced renal cell carcinoma, as a first-line treatment in combination with ipilimumab.
+- patients with advanced renal cell carcinoma, as a first-line treatment in combination with cabozantinib.
+- patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.
+
+
Classical Hodgkin Lymphoma (cHL): adult patients with classical Hodgkin lymphoma that has relapsed or progressed after
+
+- autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or
+- 3 or more lines of systemic therapy that includes autologous HSCT.
+
+
Squamous Cell Carcinoma of the Head and Neck (SCCHN): patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy.
Urothelial Carcinoma: patients with locally advanced or metastatic urothelial carcinoma who a: have disease progression during or following platinum-containing chemotherapy; have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Colorectal Cancer: adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as a single agent or in combination with ipilimumab.
Hepatocellular Carcinoma (HCC): patients with hepatocellular carcinoma who have been previously treated with sorafenib, as a single agent or in combination with ipilimumab. a (1.10)
Esophageal Squamous Cell Carcinoma (ESCC): patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy.
Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma:
+
+- patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy.
+- This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
+- Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analog plus dexamethasone is not recommended outside of controlled clinical trials.
+
","Immunological Chemotherapy, Immunosuppressant
","Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth.
Combined nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) mediated inhibition results in enhanced T-cell function that is greater than the effects of either antibody alone, and results in improved anti-tumor responses in metastatic melanoma and advanced RCC. In murine syngeneic tumor models, dual blockade of PD-1 and CTLA-4 resulted in increased anti-tumor activity.
","Administer by intravenous infusion based upon recommended infusion rate for each indication.
Unresectable or metastatic melanoma:
+
+- 240 mg every 2 weeks or 480 mg every 4 weeks.
+- 1 mg/kg followed by ipilimumab 3 mg/kg on the same day every 3 weeks for 4 doses, then 240 mg every 2 weeks or 480 mg every 4 weeks.
+
+
Adjuvant treatment of melanoma: 240 mg every 2 weeks or 480 mg every 4 weeks.
Metastatic non-small-cell lung cancer:
+
+- 3 mg/kg every 2 weeks with ipilimumab 1 mg/kg every 6 weeks.
+- 360 mg every 3 weeks with ipilimumab 1 mg/kg every 6 weeks and 2 cycles of platinum-doublet chemotherapy.
+- 240 mg every 2 weeks or 480 mg every 4 weeks.
+
+
Malignant pleural mesothelioma: 360 mg every 3 weeks with ipilimumab 1 mg/kg every 6 weeks.
Advanced renal cell carcinoma:
+
+- 3 mg/kg followed by ipilimumab 1 mg/kg on the same day every 3 weeks for 4 doses, then 240 mg every 2 weeks or 480 mg every 4 weeks.
+- 240 mg every 2 weeks or 480 mg every 4 weeks administered in combination with cabozantinib 40 mg once daily without food.
+- 240 mg every 2 weeks or 480 mg every 4 weeks.
+
+
Classical Hodgkin lymphoma: 240 mg every 2 weeks or 480 mg every 4 weeks.
Recurrent or metastatic squamous cell carcinoma of the head and neck: 240 mg every 2 weeks or 480 mg every 4 weeks.
Locally advanced or metastatic urothelial carcinoma: 240 mg every 2 weeks or 480 mg every 4 weeks.
Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer:
+
+- Adult and pediatric patients ≥40 kg: 240 mg every 2 weeks or 480 mg every 4 weeks.
+- Pediatric patients <40 kg: 3 mg/kg every 2 weeks.
+- Adult and pediatric patients ≥40 kg: 3 mg/kg followed by ipilimumab 1 mg/kg on the same day every 3 weeks for 4 doses, then 240 mg every 2 weeks or 480 mg every 4 weeks.
+
+
Hepatocellular carcinoma:
+
+- 240 mg every 2 weeks or 480 mg every 4 weeks.
+- 1 mg/kg followed by ipilimumab 3 mg/kg on the same day every 3 weeks for 4 doses, then 240 mg every 2 weeks or 480 mg every 4 weeks.
+
+
Esophageal squamous cell carcinoma: 240 mg every 2 weeks or 480 mg every 4 weeks.
Gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma (GC, GEJC, or EAC):
+
+- 360 mg every 3 weeks with fluoropyrimidine- and platinum-containing chemotherapy every 3 weeks.
+- 240 mg every 2 weeks with fluoropyrimidine- and platinum-containing chemotherapy every 2 weeks.
+
",,,"None
","Most common adverse reactions (incidence ≥20%) in patients were:
+
+- As a single agent: fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, pyrexia, headache, abdominal pain, and vomiting.
+- In combination with ipilimumab: fatigue, diarrhea, rash, pruritus, nausea, musculoskeletal pain, pyrexia, cough, decreased appetite, vomiting, abdominal pain, dyspnea, upper respiratory tract infection, arthralgia, headache, hypothyroidism, decreased weight, and dizziness.
+- In combination with ipilimumab and platinum-doublet chemotherapy: fatigue, musculoskeletal pain, nausea, diarrhea, rash, decreased appetite, constipation, and pruritus.
+- In combination with cabozantinib: diarrhea, fatigue, hepatotoxicity, palmar-plantar
erythrodysaesthesia syndrome, stomatitis, rash, hypertension, hypothyroidism,
musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough,
and upper respiratory tract infection.
+- In combination with fluoropyrimidine- and platinum-containing chemotherapy: peripheral neuropathy, nausea, fatigue, diarrhea, vomiting, decreased appetite, abdominal pain, constipation, and musculoskeletal pain.
+
","Pregnancy: Based on data from animal studies and its mechanism of action, Nivolumab can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of nivolumab to cynomolgus monkeys from the onset of organogenesis through delivery resulted in increased abortion and premature infant death. Human IgG4 is known to cross the placental barrier and nivolumab is an immunoglobulin G4 (IgG4); therefore, nivolumab has the potential to be transmitted from the mother to the developing fetus. The effects of Nivolumab are likely to be greater during the second and third trimesters of pregnancy. There are no available data on Nivolumab use in pregnant women to evaluate a drug-associated risk. Advise pregnant women of the potential risk to a fetus.
Lactation: There are no data on the presence of nivolumab in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment and for 5 months after the last dose of nivolumab.
","Immune-Mediated Adverse Reactions:
+
+- Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis and hepatotoxicity, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, and immune-mediated nephritis and renal dysfunction.
+- Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.
+- Withhold or permanently discontinue based on severity and type of reaction.
+
+
Infusion-related reactions: Interrupt, slow the rate of infusion, or permanently discontinue Nivolumab based on severity of reaction.
Complications of allogeneic HSCT: Fatal and other serious complications can occur in patient who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody.
Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception.
","Pediatric Use: The safety and effectiveness of Nivolumab as a single agent and in combination with ipilimumab have been established in pediatric patients age 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
",,,,"Store under refrigeration at 2°C to 8°C. Protect from light by storing in the original package until time of use. Do not freeze or shake.
",10
+1590,Nitroglycerin (Sublingual Tablet),nitroglycerin-sublingual-tablet-1590,,Nitrates: Coronary vasodilators,Angina pectoris,"Nitroglycerin sublingual tablet is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease
","Nitrates: Coronary vasodilators
","Nitroglycerin forms free radical nitric oxide (NO) which activates guanylate cyclase, resulting in an increase of guanosine 3'5' monophosphate in smooth muscle and other tissues. These events lead to dephosphorylation of myosin light chains, which regulate the contractile state in smooth muscle and result in vasodilatation.
","One sublingual tablet should be dissolved under the tongue at the first sign of an acute anginal attack. The dose may be repeated approximately every five minutes, until relief is obtained. If the pain persists after a total of 3 tablets in a 15-minute period, prompt medical attention is recommended.
",,"Patients receiving antihypertensive drugs, beta-adrenergic blockers or phenothiazines and nitrates should be observed for possible additive hypotensive effects. Marked orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used concomitantly. Concomitant use of nitrates and alcohol may cause hypotension. The vasodilatory and hemodynamic effects of Nitroglycerin may be enhanced by concomitant administration of aspirin. Patients receiving sublingual Nitroglycerin should avoid ergotamine and related drugs or be monitored for symptoms of ergotism if this is not possible.
","Sublingual Nitroglycerin therapy is contraindicated in patients with early myocardial infarction, severe anemia, increased intracranial pressure and those with a known hypersensitivity to Nitroglycerin. Administration of Nitroglycerin is contraindicated in patients who are using sildenafil citrate since sildenafil citrate has been shown to potentiate the hypotensive effects of organic nitrates.
","Headache which may be severe and persistent may occur immediately after use. Vertigo, dizziness, weakness, palpitation and other manifestations of postural hypotension may develop occasionally.
","Nitroglycerin should be given to a pregnant woman only if clearly needed. It is not known whether Nitroglycerin is excreted in human milk.
","Only the smallest dose required for effective control of the acute anginal attack should be used. Excessive use may lead to the development of tolerance. This drug should be used with caution in patients who may be volume-depleted or are alredy hypotensive.
",,,,,"Store in a cool and dry place away from light and heat. Keep all medicines out of the reach of children.
",10
+1589,Nitroglycerin (Sublingual Spray),nitroglycerin-sublingual-spray-1589,,Nitrates: Coronary vasodilators,Angina pectoris,"Nitroglycerin sublingual spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
","Nitrates: Coronary vasodilators
","The principal pharmacological action of nitroglycerin is relaxation of vascular smooth muscle, producing a vasodilator effect on both peripheral arteries and veins with more prominent effects on the latter. Dilation of the post-capillary vessels, including large veins, promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular enddiastolic pressure (pre-load). Arteriolar relaxation reduces systemic vascular resistance and arterial pressure (after-load).
","At the onset of an attack, 1 or 2 metered sprays should be administered under the tongue. No more than 3 metered sprays are recommended within a 15 minute period. If the chest pain persists, prompt medical attention is recommended. Nitroglycerin spray may be used prophylactically 5 to 10 minutes prior to engaging in activities which might precipitate an acute attack.
",,"Use of alcohol with Nitroglycerin may produce severe hypotension and collapse. Oral Nitroglycerin may enhance the bioavailability of dihydroergotamine. Orthostatic hypotension may occur with the combined use of calcium channel blocker, phenothiazines and tricyclic antidepressants.
","Hypersensitivity to nitrates or any constituents of the formulation. Hypotension, hypovolaemia, severe anaemia, cerebral haemorrhage and brain trauma, mitral stenosis and angina caused by hypertrophic obstructive cardiomyopathy. Concomitant administration of phosphodiesterase inhibitors used for the treatment of erectile dysfunction.
","A number of nitrate related adverse effects may occur including headache, facial flushing, dizziness, nausea, vomiting, feelings of weakness, postural hypotension and reflex tachycardia .
","Pregnancy Category C. There are no adequate and well controlled studies in pregnant women. Nitroglycerin should be given to pregnant women only if clearly needed. It is not known whether nitroglycerin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Nitroglycerin spray is administered to a nursing woman.
","The use of Nitroglycerin during the early days of acute myocardial infarction requires particular attention to monitoring hemodynamics and clinical status. Nitroglycerin should be used with caution in patients with severely impaired renal or hepatic function, hypothyroidism, malnutrition or hypothermia.
","Safety and effectiveness of nitroglycerin in pediatric patients have not been established.
","Nitrate overdosage may result in: severe hypotension, persistent throbbing headache, vertigo, palpitation, visual disturbance, flushing and perspiring skin (later becoming cold and cyanotic), nausea and vomiting (possibly with colic and even bloody diarrhea), syncope (especially in the upright posture), methemoglobinemia with cyanosis and anorexia, initial hyperpnea, dyspnea and slow breathing, slow pulse, heart block, increased intracranial pressure with cerebral symptoms of confusion and moderate fever, paralysis and coma followed by clonic convulsions and possibly death due to circulatory collapse.
Methemoglobinemia: Case reports of clinically significant methemoglobinemia are rare at conventional doses of organic nitrates. The formation of methemoglobin is dose-related and in the case of genetic abnormalities of hemoglobin that favor methemoglobin formation, even conventional doses of organic nitrates could produce harmful concentrations of methemoglobin.
Treatment of Overdosage: Keep the patient recumbent in a shock position and comfortably warm. Passive movement of the extremities may aid venous return. Administer oxygen and artificial ventilation, if necessary. If methemoglobinemia is present, administration of methylene blue (1% solution), 1-2 mg per kilogram of body weight intravenously, may be required. If an excessive quantity of Nitroglycerin spray has been recently swallowed, gastric lavage may be of use.
",,,"Store in a cool and dry place away from light and heat. Keep all medicines out of the reach of children.
",12
+532,Nitroglycerin (Oral preparation),nitroglycerin-oral-preparation-532,,Nitrates: Coronary vasodilators,Severe hypertension,"Nitroglycerin is indicated for the prophylaxis of angina pectoris. The onset of action is not sufficiently rapid for this form to be useful in aborting an acute anginal episode.
","Nitrates: Coronary vasodilators
","Nitroglycerin causes relaxation of vascular smooth muscle, producing a vasodilator effect on both peripheral arteries and veins. Dilation of veins promote peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure (preload) and relaxation of arteries reduce systemic vascular resistance and arterial pressure (afterload).
","Dosage should always to be adjusted according to the requirement and response obtained by the individual patient and the severity of the anginal pain. For adults, one Nitroglycerin 2.6 mg sustained released tablet or capsule in morning and evening. This should be taken empty stomach.
",,"Nitroglycerin dilates peripheral blood vessels and may increase the antihypertensive properties of vasodilators, calcium antagonists, beta-adrenergic blockers. Concomitant use of nitrates with tricyclic antidepressants and alcohol may cause high blood pressure. Concomitant use of nitrates with phosphodiesterase type 5 (PDE5) inhibitors, such as sildenafil, vardenafil and tadalafil cause fall in blood pressure. Aspirin decreases the clearance and enhances the hemodynamic effects of nitroglycerin. Nitroglycerin may reduce the pharmacologic effects of heparin when used concomitantly. Nitrates increase the bioavailability of dihydroergotamine.
","Nitroglycerin is contraindicated in patients with a known hypersensitivity to nitroglycerin, other organic nitrates, or nitrites or to the excipients of the medicine. It is also contraindicated in patients with acute myocardial infarction, marked anaemia, head trauma, cerebral haemorrhage, or closed angle glaucoma.
","Headache may occur at the onset of treatment but will usually subside after a few days. If the headache persists dosage should be decreased. Other side effects include tachycardia, postural hypotension and syncope, cyanosis and methaemoglobinaemia.
","Nitroglycerin should not be used during pregnancy or lactation unless considered essential by the physician.
","Nitroglycerin should be used with caution in patients who are predisposed to closed-angle glaucoma. As with other drugs for the treatment of angina pectoris, abrupt discontinuation of therapy may lead to exacerbation of symptoms. When discontinuing long term treatment, the dosage should be reduced gradually over several days, and the patient carefully monitored. The use of nitroglycerin during the early days of acute myocardial infarction requires particular attention to hemodynamic monitoring and clinical status to avoid the hazards of hypotension and tachycardia.
",,,,,"Store in a cool and dry place away from light and heat. Keep all medicines out of the reach of children.
",10
+1305,Nitroglycerin (Ointment),nitroglycerin-ointment-1305,,Drugs used in Ano-rectal region,Chronic anal fissure,"The ointment will help to relieve the symptom of pain caused by chronic anal fissures.
","Drugs used in Ano-rectal region
","The principal pharmacologic action of glyceryl trinitrate is mediated via the release of nitric oxide. When glyceryl trinitrate ointment is applied by the intra-anal route,the internal anal sphincter becomes relaxed.Hypertonicity of the internal but not the external anal sphincter is a predisposing factor in the formation of anal fissures.
","Nitroglycerin 0.4% ointment should be inserted into the anal cavity with an applicator.The ointment must be inserted at least 1 cm into the anus.The dose is to be applied intra-anally every twelve hours. Treatment may be continued until the pain abates,up to a maximum of 8 weeks.
",,"The following medicines may increase the blood pressure lowering effect of glyceryl trinitrate ointment-
+
+- Medicines for depression
+- Medicines for erectile dysfunction
+- Medicines for high blood pressure
+- Diuretics
+- Commonly used tranquillizers
+- Medicines used to treat heart problems
+
","Headache and dizziness is a common side effect experienced with Nitroglycerin 0.4% ointment. A possible side effect is reduced control over bowel movements and leaking of bowel motions although this is expected to be a rare event.
","Headache and dizziness is a common side effect experienced with Nitroglycerin 0.4% ointment. A possible side effect is reduced control over bowel movements and leaking of bowel motions although this is expected to be a rare event.
","There are no adequate data from the use of Nitroglycerin in pregnant women. Animal studies are inconclusive with respect to effects on pregnancy embryonal/foetal parturition and postnatal development. This ointment should not be used during pregnancy. It is not known whether Nitroglycerin is excreted in human milk. Due to the potential harmful effects on the breast fed child, the use of this ointment is not recommended during breast feeding.
","Nitroglycerin 0.4% ointment should be used with caution in patients who have severe hepatic or renal disease.It should not be used if patient suffers from severe anemia, glaucoma, hypotension, increased intracranial pressure.
","Pediatric Use: It is not recommended for use in children and adolescents below 18 years of age due to lack of data on safety and efficacy
","Accidental overdose may result in hypotension and reflex tachycardia. Because the hypotension associated with nitroglycerin overdose is the result of venodilation and arterial hypovolaemia, prudent therapy in this situation should be directed toward increasing central fluid volume. Excessive dosage may also give rise to methaemogiobinaemia. This should be treated with methylene blue infusion.
",,,"Store below 25°C. Do not freeze. Keep all medicines out of reach of the children.
",12
+1591,Nitroglycerin (IV Infusion),nitroglycerin-iv-infusion-1591,,Nitrates: Coronary vasodilators,Angina pectoris,"Nitroglycerin Injection is indicated for the treatment of peri-operative hypertension; for controlling of congestive heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and beta blockers and for induction of Intraoperative hypotension.
","Nitrates: Coronary vasodilators
","The principal pharmacological action of nitroglycerin is relaxation of vascular smooth muscle and consequent dilatation of peripheral arteries and veins. Dilatation of the veins promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure and pulmonary capillary wedge pressure (preload). Arteriolar relaxation reduces systemic vascular resistance,systolic arterial pressure, and mean arterial pressure (after load). Dilatation of the coronary arteries also occurs.
","Not for direct intravenous injection. Nitroglycerin injection is a concentrated, potent drug which must be diluted in dextrose (5%) injection or sodium chloride (0.9%) injection prior to its infusion. Nitroglycerin injection should not be mixed with other drugs.
Initial Dilution: Aseptically transfer the contents of one nitroglycerin ampoule (containing 50 mg of nitroglycerin) into a 500 ml glass bottle of either Dextrose (5%) Injection or Sodium Chloride Injection (0.9%).This yields a final concentration of 100 mcg/ml.
Maintenance Dilution: It is important to consider the fluid requirements of the patient as well as the expected duration of infusion in selecting the appropriate dilution of Nitroglycerin Injection. After the initial dosage titration, the concentration of the solution may be increased, if necessary, to limit fluids given to the patient. The nitroglycerin concentration should not exceed 400 mcg/ml.
",,"The vasodilating effects of nitroglycerin may be additive with those of other vasodilators. Administration of nitroglycerin infusions through the same infusion set as blood can result in pseudoagglutination and hemolysis. More generally, nitroglycerin in 5% dextrose or sodium chloride 0.9% should not be mixed with any other medication of any kind. Intravenous nitroglycerin interferes, at least in some patients, with the anticoagulant effect of heparin. In patients receiving intravenous nitroglycerin, concomitant heparin therapy should be guided by frequent measurement of the activated partial thromboplastin time.
","Allergic reactionsto organic nitrates are extremely rare,but they do occur. Nitroglycerin Injection is contraindicated in patients who are allergic to it. In patients with pericardial tamponade, restrictive cardiomyopathy, or constrictive pericarditis, cardiac output is dependent upon venousreturn. Intravenous nitroglycerin is contraindicated in patients with these conditions.
","Adverse reactions to nitroglycerin are generally dose-related and almost all of these reactions are the result of nitroglycerin's activity as a vasodilator. Headache, which may be severe, is the most commonly reported side effect. Headache may be recurrent with each daily dose, especially at higher doses. Transient episodes of lightheadedness, occasionally related to blood pressure changes, may also occur. Hypotension occurs infrequently, but in some patients it may be severe enough to warrant discontinuation of therapy. Syncope, crescendo angina, and rebound hypertension have been reported but are uncommon. Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients. Methemoglobinemia is so infrequent at these doses that further discussion of its diagnosis and treatment is deferred.
","Pregnancy category C. It is not known whether nitroglycerin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nitroglycerin injection is administered to a nursing mother.
","Severe hypotension and shock may occur with even small doses of nitroglycerin. This drug should therefore be used with caution in patients who may be volume depleted or who, for whatever reason, are already hypotensive. Hypotension induced by nitroglycerin may be accompanied by paradoxical bradycardia and increased angina pectoris. Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy. As tolerance to other forms of nitroglycerin develops,the effect of sublingual nitroglycerin on exercise tolerance, although still observable, is somewhat blunted. In industrial workers who have had long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance clearly occurs. Chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitratesfrom these workers, demonstrating the existence of true physical dependence.
","Safety and effectiveness in children have not been established.
","Homodynamic Effects: The ill effects of nitroglycerin overdose are generally the results of nitroglycerin's capacity to induce vasodilatation, venous pooling, reduced cardiac output, and hypotension. These hemodynamic changes may have protean manifestations, including increased intracranial pressure, with any or all of persistent throbbing headache, confusion, and moderate fever; vertigo; palpitation; visual disturbances; nausea and vomiting (possibly with colic and even bloody diarrhea); syncope (especially in the upright posture); air hunger and dyspnea, later followed by reduced ventilatory effort; diaphoresis, with the skin either flushed or cold and clammy; heart block and bradycardia; paralysis; coma; seizures; and death.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+815,Nitrofurazone,nitrofurazone-815,,Topical Antibiotic preparations,Wounds,"Nitrofurazone is indicated in the infectious conditions of the skin such as burns, wounds, ulcers, skin infections and skin grafting.
","Topical Antibiotic preparations
","Nitrofurazone is a broad spectrum topical antibacterial agent indicated for the treatment of mixed skin infections of superficial wounds and diseases of the skin.
","To be applied directly to the lesion or on gauze first; 2-3 times daily or as advised by the physician.
",,,"Nitrofurazone is contraindicated to patients with known sensitivity to Nitrofurazone. It is not advisable to use Nitrofurazone after the infection is cured. It should be used with caution in patients with known or suspected renal impairment.
","Sensitization and generalized allergic skin reactions may be produced after few days of initial application. Cross sensitization to other Nitrofurazone derivatives may occur. Intolerance to Nitrofurazone necessitating withdrawal has been encountered.
","Pregnancy category- B
","G6PD deficiency, renal impairment.
",,,,,,8
+1330,Nitrofurantoin + Nitrofurantoin Microcrystals,nitrofurantoin-nitrofurantoin-microcrystals-1330,https://medex.com.bd/attachments/1luZOfGpEVEJ3JMeN9AH3Gq5seVa9m/nitrofurantoin-nitrofurantoin-microcrystals-prescribing-information,Systemic Urinary Anti- infective,Urinary tract infection,"For the treatment of and prophylaxis against acute or recurrent, uncomplicated lower urinary tract infections or pyelitis either spontaneous or following surgical procedures. Nitrofurantoin is specifically indicated for the treatment of infections when due to susceptible strains of Escherichia coli, enterococci, staphylococci, Citrobacter, Klebsiella and Enterobacter.
","Systemic Urinary Anti- infective
","Each capsule contains two forms of nitrofurantoin. Twenty-five percent is macrocrystalline nitrofurantoin, which has slower dissolution and absorption than nitrofurantoin monohydrate. The remaining 75% is nitrofurantoin monohydrate contained in a powder blend which, upon exposure to gastric and intestinal fluids, forms a gel matrix that releases nitrofurantoin over time. This capsule is highly soluble in urine, to which it may impart a brown color. When administered with food, the bioavailability of nitrofurantoin is increased by approximately 40%.
","Adults and Pediatric Patients Over 12 Years: One 100 mg capsule every 12 hours for seven days. Capsules should be taken with food.
The administration of high doses of nitrofurantoin to rats causes temporary spermatogenic arrest; this is reversible on discontinuing the drug. Doses of 10 mg/kg/day or greater in healthy human males may, in certain unpredictable instances, produce a slight to moderate spermatogenic arrest with a decrease in sperm count.
",,"Antacids containing magnesium trisilicate, when administered concomitantly with nitrofurantoin, reduce both the rate and extent of absorption. The mechanism for this interaction probably is adsorption of nitrofurantoin onto the surface of magnesium trisilicate. Uricosuric drugs, such as probenecid and sulfinpyrazone, can inhibit renal tubular secretion of nitrofurantoin. The resulting increase in nitrofurantoin serum levels may increase toxicity, and the decreased urinary levels could lessen its efficacy as a urinary tract antibacterial
",,"In clinical trials of Macrobid, the most frequent clinical adverse events that were reported as possibly or probably drug related were nausea (8%), headache (6%), and flatulence (1.5%)
","Pregnancy Category B. Nitrofurantoin has been detected in human breast milk in trace amounts. Because of the potential for serious adverse reactions from nitrofurantoin in nursing infants under one month of age, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
",,,"Occasional incidents of acute overdosage of nitrofurantoin have not resulted in any specific symptoms other than vomiting. Induction of emesis is recommended. There is no specific antidote, but a high fluid intake should be maintained to promote urinary excretion of the drug. Nitrofurantoin is dialyzable.
",,,,8
+814,Nitrofurantoin,nitrofurantoin-814,https://medex.com.bd/attachments/UCV0pRCFJo3xcHrhQVKrlSGQKEuHuD/nitrofurantoin-oral-suspension-prescribing-information,Systemic Urinary Anti- infective,Urinary tract infection,"Nitrofurantoin is specifically indicated for the treatment & prophylaxis of urinary tract infections caused by susceptible strains of Escherichia coli, Enterococci, Staphylococcus aureus, Staphylococcus saprophyticus and certain susceptible strains of Klebsiella and Enterobacter species.
","Systemic Urinary Anti- infective
","Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin is highly soluble in urine, to which it may impart a brown color. Nitrofurantoin inactivates or alters bacterial ribosomal proteins and other macromolecules. Nitrofurantoin has been shown to be active against the following bacteria: Gram-Positive Aerobes Staphylococcus saprophyticus, Coagulase-negative staphylococci (including Staphylococcus epidermidis), Enterococcus faecalis, Staphylococcus aureus, Streptococcus agalactiae, Group D streptococci, Viridans group streptococci. Gram-Negative Aerobes- Escherichia coli, Citrobacter amalonaticus, Citrobacter diversus, Citrobacter freundii, Klebsiella oxytoca, Klebsiella ozaenae.
","Nitrofurantoin tablet (In adults):
+
+- Uncomplicated urinary tract infections: 50-100 mg four times a day- the lower dosage level is recommended. Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained.
+- For long-term suppressive therapy: In adults, a reduction of dosage to 50-100 mg at bedtime may be adequate.
+
+Nitrofurantoin capsule (In adults):
+
+- Acute Uncomplicated Urinary Tract Infections (UTIs): 50 mg four times daily for 7 days.
+- Long term suppression: 50-100 mg once a day.
+- Prophylaxis: 50 mg four times daily for the duration of procedure and for three days thereafter.
+
+Nitrofurantoin SR capsule:
+
+- Adults and Children over 12 years: One 100 mg capsule every 12 hours for seven days.
+- Genito-urinary surgical prophylaxis: One capsule twice daily on day of procedure and for next 3 days.
+
+Nitrofurantoin suspension: Children: 5-7 mg/kg/day in four divided doses (contraindicated under one month of age). The average dose of Nintoin suspension for pediatric patients are as follows-
+
+- 7 to 11 kg: ½ (2.5 ml) teaspoonfuls 4 times daily.
+- 12 to 21 kg: 1 (5 ml) teaspoonfuls 4 times daily.
+- 22 to 30 kg: 1½ (7.5 ml) teaspoonfuls 4 times daily.
+- 31 to 41 kg: 2 (10 ml) teaspoonfuls 4 times daily.
+
+Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained. For long-term suppressive therapy in children, doses as low as 1 mg/kg per 24 hours, given in a single dose or in two divided doses, may be adequate.
","Nitrofurantoin should be taken with food.
","Antacids containing Magnesium Trisilicate, when administered concomitantly with Nitrofurantoin, reduce both the rate and extent of absorption of Uricosuric drugs, such as Probenecid and Sulfinpyrazone, can inhibit renal tubular secretion of Nitrofurantoin.
","Anuria, oliguria or significant impairment of renal function are contraindications. This drug is contraindicated in pregnant patients at 38-42 weeks, during labor and delivery. Nitrofurantoin is also contraindicated in those patients with known hypersensitivity to Nitrofurantoin.
","The most frequent clinical adverse events are nausea, headache, and flatulence. Other less occurred adverse events are diarrhea, dyspepsia, abdominal pain, constipation, emesis, dizziness and drowsiness.
","Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Nitrofurantoin has been detected in human breast milk in trace amounts. Because of the potential for serious adverse reactions from Nitrofurantoin in nursing infants under one month of age, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","If acute, sub-acute or chronic pulmonary reactions occur, Nitrofurantoin should be discontinued. Antacid preparations containing magnesium trisilicate should not be taken while taking Nitrofurantoin.
",,"Occasional incidents of acute overdosage of Nitrofurantoin have not resulted in any specific symptoms other than vomiting. Induction of emesis is recommended.
",,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",12
+813,Nitrazepam,nitrazepam-813,,Benzodiazepine hypnotics,Insomnia and sleep disturbances,"Short-term management of insomnia, Infantile spasms
","Benzodiazepine hypnotics
","Nitrazepam is a benzodiazepine with a pronounced sleep-inducing activity. It depresses the reticular-activating system in the brainstem by enhancing the inhibitory effect of GABA on brain cells, thus preventing excessive brain activity.
","Short-term management of insomnia:
+
+- Adult: 5 mg at night; increase to 10 mg if necessary.
+- Elderly: and debilitated patients: ≤normal adult dose.
+
+Infantile spasms:
+
+- Child: Infants: 125 mcg/kg bid; gradually increase to 250-500 mcg/kg bid.
+
","May be taken with or without food
","CNS depressant effect increased with alcohol, barbiturates, TCAs, phenothiazines, morphine derivatives. Effects may be antagonised by theophylline. Increased levels/effects with probenecid. Reduced levels/effects with rifampicin. May reduce effects of levodopa.
","Myasthenia gravis, narrow-angle glaucoma, severe respiratory insufficiency, sleep apnoea syndrome, severe hepatic impairment, porphyria.
","Hypotension, palpitation; agitation, aggressiveness, amnesia, ataxia, confusion, delusions, disorientation, dizziness, fatigue, hallucination, hangover, headache, irritability, nightmares, psychoses, rage, restlessness, sedation; rash; changes in libido; constipation, diarrhoea, excessive salivation, heartburn, nausea, vomiting; granulocytopenia, leukopenia; falling, muscle weakness; blurred or double vision; tinnitus (associated with withdrawal); aspiration, increased bronchial secretion, dyspnoea.
","Category not classified
","May induce anterograde amnesia; caution patients to have uninterrupted sleep of 7-8 hr after ingestion of dose. May impair ability to drive or operate machinery. Depression, especially if suicidal risk may be present. History of drug abuse or acute alcoholism. Hepatic and renal impairment. Respiratory disease. Debilitated patients. Patients who are at risk of falls. Children, elderly. Pregnancy and lactation.
",,"Symptoms: Somnolence, drowsiness, confusion, ataxia, impaired reflexes, coma, dyspnoea, hypotension, respiratory and cardiovascular depression.
Management: Supportive. Gastric lavage may be beneficial if performed soon after ingestion. Flumazenil may reverse benzodiazepine-induced CNS depression.
",,,"Store at room temperature. Protect from light and moisture.
",12
+812,Nitazoxanide,nitazoxanide-812,https://medex.com.bd/attachments/jzJKtTM7UKJXspJocVWQd65qmJjmeD/nitazoxanide-prescribing-information,Anti-diarrhoeal Antiprotozoal,Giardiasis,"Nitazoxanide is indicated for the treatment of diarrhea caused by Cryptosporidium parvum, Giardia lamblia and Entamoeba histolytica.
","Anti-diarrhoeal Antiprotozoal
","Nitazoxanide is a synthetic antiprotozoal agent for oral administration. The antiprotozoal activity of Nitazoxanide is believed to be interference with the Pyruvate Ferredoxin Oxido Reductase (PFOR) enzyme-dependant electron transfer reaction. This reaction is essential for anaerobic energy metabolism of the protozoa. Nitazoxanide and its metabolites, tizoxanid are active in vitro in inhibiting the growth of sporozoites and oocyst of Cryptosporidium parvum and trophozoites of Giardia lamblia.
","Age 1-3 years: 1 tea-spoonfull or 5 ml suspension every 12 hours for 3 days.
Age 4-11 years: 2 tea-spoonfulls or 10 ml suspension every 12 hours for 3 days.
Age 12 years or above: 5 tea-spoonfulls (25 ml) suspension or 1 tablet every 12 hours for 3 days.
It is recommended to be administered with food.
",,"It is highly bound to plasma protein. Therefore, caution should be exercised when administering Nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic index.
","It is contraindicated in patients with known hypersensitivity to Nitazoxanide or any components of the preparation.
","The most frequent side effects, reported by Nitazoxanide are abdominal pain, vomiting and headache. These side effects are typically mild and transient in nature. Very rare side effects include- nausea, anorexia, flatulence, increased appetite, enlarged salivary glands, increased creatinine & SGPT level, pruritus, rhinitis, sweating, dizziness, discolored urine etc.
","US FDA pregnancy category of Nitazoxanide is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nitazoxanide have been shown to be excreted in human milk. So, caution should be exercised when Nitazoxanide is administered during lactation.
","Nitazoxanide must be administered with caution to patients with hepatic & biliary disease and to patients with renal disease.
",,,,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",10
+78,Oral Rehydration Salt [Powder],oral-rehydration-salt-powder-78,https://medex.com.bd/attachments/Ss4DBqA84W0H0TtWZcMqsM5cpD7vGe/oral-rehydration-salt-powder-prescribing-information,Oral electrolytes preparations,,"Oral Rehydration Salt replacement of fluid and electrolyte loss due to-
+
+- Acute diarrhea
+- Vomiting
+- Dehydration
+
+Other conditions of fluid loss or lack of intake in patients of all age groups.
","Oral electrolytes preparations
","This is the preparation of oral rehydration salt. It is composed of anhydrous glucose, sodium chloride, potassium chloride and sodium citrate (as dihydrate). This is a single formulation of glucose based oral rehydration salt to treat or prevent dehydration from diarrhea of any etiology, including cholera and in individuals of any age. This also prevents acidosis due to electrolyte imbalance.
","Daily dose should be equivalent to patients' fluid requirement for maintenance and replenishment of losses. During this therapy, mother should not stop breastfeeding to their child and normal food should be continued in case of adults.
Children less than 2 years: After each loose stool or vomiting 50-100 mL (10 to 20 teaspoonful) of prepared this.
Children 2 to 10 years: After each loose stool or vomiting 100-200 mL (1/2 to 1 glass) of prepared oral saline.
Adult and children above 10 years: After each loose stool or vomiting 200-400 mL (1 to 2 glass) of prepared this.
","
+- Disperse the full contents of the sachet in 500 mL (1/2 liter) of pure drinking water.
+- Do not mix the oral saline with hot water or heat the prepared solution.
+- Discard the unused prepared oral saline after 12 hours of preparation.
+
","There are no known drug interactions and none well documented.
",,,,"Depressed renal function, severe continuing diarrhea or other critical fluid losses may need supplementation with parenteral fluids along with oral saline.
",,,,,"Do not store above 30°C temperature. Keep away from light and wet places. Keep out of reach of children.
",8
+352,Oral Rehydration Salt [Flavored],oral-rehydration-salt-flavored-352,,Oral electrolytes preparations,Vomiting,"Indicated for Diarrhea, Dehydration, Vomiting, Fluid and Electrolytes imbalance
","Oral electrolytes preparations
","Potassium chloride is a major cation of the intracellular fluid. It plays an active role in the conduction of nerve impulses in the heart, brain and skeletal muscle; contraction of cardiac skeletal and smooth muscles; maintenance of normal renal function, acid-base balance, carbohydrate metabolism and gastric secretion.
Sodium chloride is the major extracellular cation. It is important in electrolyte and fluid balance, osmotic pressure control and water distribution as it restores sodium ions. It is used as a source of electrolytes and water for hydration, treatment of metabolic acidosis, priming solution in haemodialysis and treatment of hyperosmolar diabetes.
It is also used as diluents for infusion of compatible drug additives.
Dextrose is a monosaccharide that is used as a source of calories and water for hydration. It helps to reduce loss of body protein and nitrogen. It also promotes glycogen deposition in the liver. When used with insulin, it stimulates the uptake of potassium by cells, especially in muscle tissue, thus lowering serum potassium levels.
Sodium bicarbonate raises blood and urinary pH by dissociation to provide bicarbonate ions, which neutralises the hydrogen ion concentration. It also neutralises gastric acid via production of carbon dioxide.
","Daily dose should be equivalent to patients fluid requirement for maintenance and replenishment of losses. During saline therapy mother should not stop breast-feeding to their child and normal food should be continued in case of adults.
Children less than 2 years: After each loose stool or vomiting 10 to 20 spoonful (50-100 ml) of prepared saline.
Children 2 to 10 years: After each loose stool or vomiting 100-200 ml of prepared oral saline.
Adult and children above 10 years: After each loose stool or vomiting 200-400 ml of prepared saline.
",,"There are no known drug interactions and none well documented.
","Patients with known hypersensitivity.
","No significant side effects.
","Pregnancy Category- Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
","Depressed renal function, severe continuing diarrhoea or other critical fluid losses may need supplementation with parenteral fluids along with oral saline. Reconstitue saline should be used within 6 hours.
",,,,,,9
+1209,Oral Polio Vaccine,oral-polio-vaccine-1209,https://medex.com.bd/attachments/WHn3wNOHCfigz6UmhUzL8cMa56vxyZ/oral-polio-vaccine-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Active immunisation against Poliomyelitis,"Polio vaccines are vaccines used to prevent poliomyelitis (polio)
","Vaccines, Anti-sera & Immunoglobulin
","Parenteral inactivated poliovirus vaccine(IPV) chiefly induces formation of serum antibody. Infection, with oral poliovirus vaccine (OPV) or wild poliovirus, also induces development of secretory IgA antibody. In addition, infection results in virus shedding and, hence, in possible spread of virus to contacts (more likelywith wild than with vaccine virus). IPV induces a high level (90%–95%) of protection against disease, which presumably is mediated by serum antibody that prevents CNS invasion resulting from viremia. IPV induces little protection against infection but does modify the related virus shedding- chiefly that from the oropharynx. Infection, whether by OPV or wild virus, induces a high level of protection against disease. It also results in appreciable prevention or modification of infection because of the developmentof secretoryIgA antibody. This effect is directly protective for the vaccinee and also benefits the community, since the exposed vaccinee can play little or no part in the spread of wild virus. One major question remaining concerns the maintenance of immunity. Lifelong immunologic memory assures an enhanced serum antibody response to any infection that occurs, but will it be sufficiently rapid that when preinfection antibody cannot be detected newly formed antibody will block blood-borne viral invasion of the CNS? If not, booster doses of vaccineare indicated. OPV boosters might be indicated in any case to reinforce protection against infection and so maintain herd immunity.
","3 doses course, each dose (2-3 drops) given orally at an interval of 6-8 weeks
",,,"Diarrhoea; Hypogammaglobulinemia. Febrile illness or any active infection is present
","Paralysis (very rarely reported)
","Data not available
",,,,,,,7
+828,Oral Cholera Vaccine,oral-cholera-vaccine-828,https://medex.com.bd/attachments/3ne7XIVaeJLlylKmI1h0G2hBVukSTS/oral-cholera-vaccine-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Cholera,"Oral Cholera Vaccine is indicated for active immunization against Vibrio cholerae. The vaccine can be administered to anyone above the age of 1 year. Data for the safety and efficacy of the vaccine in infants (less than 1 year of age) is not available. The earliest onset of protection can be expected ... Read more
Oral Cholera Vaccine is indicated for active immunization against Vibrio cholerae. The vaccine can be administered to anyone above the age of 1 year. Data for the safety and efficacy of the vaccine in infants (less than 1 year of age) is not available. The earliest onset of protection can be expected 7-10 days after the completion of the primary series of the vaccine. Efficacy against Vibrio cholerae serogroup O139 was not demonstrated.
","Vaccines, Anti-sera & Immunoglobulin
",,"The recommended dose of the vaccine (1.5 ml) is to be administered orally. The primary immunization schedule consists of two doses given at an interval of at least two weeks. Cholera vaccine should not be administered parenterally (intramuscular, subcutaneous or intravenously). The vaccine is only recommended for oral administration.
Method of administration: The vaccine is presented as a suspension. After vigorous shaking of the vial, 1.5 ml should be poured into the mouth of the recipient. The vaccine administration may be optionally followed by water to facilitate ingestion, if needed. The vaccine can alternatively be administered with a disposable syringe (without needle) after removing the contents from the vial and squirted into the mouth of the recipient. The vaccine should not be administered parenterally (intramuscular, subcutaneous or intravenously). The vaccine is only recommended for oral administration.
",,,"Cholera vaccine should not be administered to subjects with either known hypersensitivity to any component of vaccine, or having shown signs of hypersensitivity after previous administration of the vaccine. Formaldehyde is used during the manufacturing process and trace amounts may be present in the final product. Caution should be taken in subjects with known hypersensitivity to formaldehyde. CVV V.N. 02 TM As with other vaccines, immunization with the cholera vaccine should be delayed in the presence of any acute illness, including acute gastrointestinal illness or acute febrile illness. A minor illness such as mild upper respiratory tract infection is not a reason to postpone immunization
","The following adverse events are known to occur with cholera vaccine use. Acute gastroenteritis, diarrhea, fever, vomiting, abdominal pain, itching, rash, nausea, weakness, cough, vertigo, dryness of mouth, oral ulcer (rare), sore throat (rare) and yellowing of urine (rare). It has been observed that the incidence of adverse events is less after the second dose as compared to the first.
","No specific clinical studies have been performed to evaluate the safety and immunogenicity of cholera vaccine in pregnant women and for the fetus. However, administration of cholera vaccine to pregnant women and nursing mother may be considered after careful evaluation of the benefits and risks in case of a medical emergency or an epidemic.
","Vaccination should be provided by a review of the medical history (especilly with regard to previous vaccination & possible occurrence of the undesirable events) and a clinical examination. As with any vaccine immunization with the cholera vaccine may not protect 100% susceptible individuals. This vaccine is also not a substitute for therapy in case of individuals suspected to be suffering from cholera or showing signs and symptoms of an acute episode of gastro intestinal disease or acute watery diarrhea. Immunocompromised persons (subsequent to a disease or immunosuppressive therapy) may not obtain the expected immune response after vaccination with the cholera vaccine. If possible, in the opinion of the medical practitioner, due consideration should be given to postpone vaccination until after the completion of the immunosuppressive treatment. As with all vaccines, appropriate medical treatment should always be available in case of a rare event of anaphylactic reactions following the administration of the vaccine. For this reason, it is recommended that the vaccinee should remain under medical supervision for at least 30 minutes after vaccination.
",,,,,"Keep out of the reach and sight of children. Store at +2 ºC to +8 ºC. Transportation should also be at +2 ºC to +8 ºC. Do not freeze. Discard vaccine if frozen. Protect from light.
",8
+827,Ondansetron,ondansetron-827,https://medex.com.bd/attachments/B0xCXUZye5d58snRCgSstmJbqV0zQG/ondansetron-tablets-oral-solution-prescribing-information,Anti-emetic drugs,Post-operative nausea and vomiting,"Ondansetron is a serotonin subtype 3 (5-HT3) receptor antagonist indicated:
+
+- Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.
+- Prevention and treatment of post-operative nausea and vomiting.
+- Prevention of radiotherapy-induced nausea and vomiting.
+
","Anti-emetic drugs
","Ondansetron is a potent, highly selective 5HT3 receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known. Chemotherapeutic agents and radiotherapy may cause release of 5HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5HT3 receptors. Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5HT3 receptors on neurons located both in the peripheral and central nervous system. The mechanisms of action in post-operative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting.
","Chemotherapy-Induced Nausea and Vomiting-
Adults, Pediatric patients (6 months to 18 years):
+
+- 8 mg tablet/orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
+- 4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
+- Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.
+
+Radiotherapy-Induced Nausea and Vomiting-
Adults:
+
+- 8 mg tablet/orodispersible tablet: Initial Dose: 8 mg orally 1 to 2 hours before radiotherapy. Post Radiotherapy: 8 mg orally every 8 hours for up to 5 days after a course of treatment.
+- 4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
+- Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.
+
+Postoperative Nausea and Vomiting-
Adults:
+
+- 8 mg tablet/orodispersible tablet: 16 mg given as two 8 mg tablets
+- 4 mg orodispersible tablet: 16 mg
+- Injection: 4 mg
+
+Pediatrics (>40 kg): Injection: 4 mg
Pediatrics (40 kg): Injection: 0.1 mg/kg
Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:
+
+- Highly emetogenic cancer chemotherapy: 30 ml (24 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy.
+- Moderate emetogenic cancer chemotherapy: 10 ml (8 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy. A further 10 ml dose should be administered after 8 hours of the first dose. One 10 ml dose should be administered twice a day (every 12 hours) for 1-2 days after completion of chemotherapy.
+
+Pediatric (4-11 years): 5 ml (4 mg) Ondansetron Oral Solution should be taken 30 minutes before the start of chemotherapy. The other 2 doses should be taken 4 and 8 hours after the first dose. Then 5 ml oral solution should be administered 3 times a day (every 8 hours) for 1-2 days after completion of chemotherapy.
+
Oral solution:
+Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):
+
+- The recommended oral dosage: 10 ml (8 mg) Ondansetron Oral Solution 3 times daily.
+- For total body irradiation: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
+- For single high-dose fraction radiotherapy to the abdomen: one 10 ml Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
+- For daily fractionated radiotherapy to the abdomen: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
+
+Postoperative Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):
+
+- 20 ml (16 mg) Ondansetron Oral Solution 1 hour before induction of anesthesia
+
+
Oral Soluble Film:
+Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:
+
+- Adult oral dose: 24 mg given successively as three 8 mg films 30 minutes before the start of chemotherapy.
+
+Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy:
+
+- Adults and pediatric patients 12 years of age and older: One 8 mg film 30 minutes before chemotherapy followed by an 8 mg dose 8 hours later. Administer one 8 mg film twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
+- Pediatric patients 4 through 11 years of age: One 4 mg film three times a day. Administer the first dose 30 minutes before chemotherapy, with subsequent doses 4 and 8 hours later. Administer one 4 mg film three times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
+- Prevention of nausea and vomiting associated with radiotherapy: The adult dosage is one 8 mg film three times a day.
+- Postoperative nausea and vomiting: The adult dose is 16 mg given successively as two 8 mg films 1 hour before anesthesia.
+
","Administration of Oral Soluble Film:
+
+- Step 1: Tear the pouch carefully along with the edge tear mark.
+- Step 2: Put the Ondansetron film on top of your tongue. It will dissolve within 20 seconds
+- Step 3: Do not chew or swallow the film whole.
+- Step 4: Swallow after the Onsaf oral soluble film dissolves. You may swallow the dissolved film with or without liquid.
+- Step 5: Wash your hands after taking Onsaf oral soluble film
+
","Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver. Because Ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance and hence, the half-life of Ondansetron. On the basis of available data, no dosage adjustment of Ondasetron is recommended for patients on these drugs.
","Contraindicated in patients known to have hypersensitivity to the drug or any of its components. Concomitant use of apomorphine.
","Frequently reported adverse events were headache, constipation and diarrhea, but the majority have been mild or moderate in nature. In chemotherapy-induced nausea and vomiting, rash has occurred in approximately 1% of patients receiving Ondansetron. There also have been reports to a sensation of flushing or warmth, hiccups and liver enzyme abnormalities. Rare cases of anaphylaxis, brochospasm, tachycardia, angina (chest pain), hypokalemia, shortness of breath have also been reported, except for bronchospasm and anaphylaxis, the relationship to Ondansetron is unclear. There have been no evidence to extrapyramidal reactions, in rare case oculogyric crisis appearing alone, as well as with other dystonic reactions without definitive clinical evidence. In case of PONV, with the exception of headache, rates of these events were not significantly different in the Ondansetron and placebo groups.
","Carcinogenic effects were not seen in 2-year studies in rats and mice with oral Ondansetron doses up to 10 and 30 mg/kg per day, respectively. Ondansetron was not mutagenic in standard tests for mutagenicity. Oral administration of Ondansetron up to 15 mg/kg per day did not affect fertility or general reproduction performance of male and female rats.
Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Ondansetron is excreted in the breast milk of rats. So caution should be exercised when Ondansetron is administered to a nursing women.
","Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of Ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.
","Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population.
Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment, a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.
4 years of age or younger: Little information is available about dosage in pediatric patients 4 years of age or younger.
Over the age of 65: Dosage adjustment is not needed in patients over the age of 65.
",,,,"Store at temperature not exceeding 30ºC in a dry place. Protect from light and moisture.
",12
+1336,Omeprazole (MUPS tablet),omeprazole-mups-tablet-1336,https://medex.com.bd/attachments/ZL8wlarTfYWwVhuciBt69g0F87i9zi/omeprazole-mups-tablet-prescribing-information,Proton Pump Inhibitor,Zollinger-Ellison syndrome,"Omeprazole MUPS tablet is indicated in-
+
+- Duodenal and Gastric ulcers
+- NSAID-induced gastric and duodenal ulcers
+- Reflux Oesophagitis
+- GERD (Gastroesophageal Reflux Disease)
+- Eradication of H. pylori with appropriate antibiotics
+- Zollinger-Ellison Syndrome
+
","Proton Pump Inhibitor
","MUPS is abbreviation for Multiple-Unit Pellet System. However, from pharmaceutical industry and research perspective, the term in general refers to MUPS compacted into tablets. Thus, the resulting tablets prepared by compaction of modified release coated multiparticulates or pellets are called as MUPS. It is the more recent and challenging technology that combines the advantages of both tablets and pellet-filled capsules in one dosage form.
Clinical advantage of omeprazole MUPS tablet compared to conventional modified-release omeprazole tablets and pellet-filled omeprazole capsules:
+
+- Ensures greater bioavailability
+- Ensures uniform emptying of micro pellets from stomach into small intestine facilitates rapid dissolution of enteric coating and drug release resulting in early Tmax and Cmax (peak time and peak plasma concentration)
+- Ensures lesser possibility of dose dumping
+- Is a combination of fast acting and sustained action
+- Ensures uniform drug release
+- Once daily dosing
+- Ensures lesser chance of localized irritation
+- Ensures better and more uniform drug absorption
+- Better than capsules in reducing the esophageal residence time
+- Minimizes fluctuation in plasma concentration of drug.
+
+Pharmacodynamic advantage:
+
+- MUPS ensure rapid and uniform gastric emptying and subsequently uniform drug dissolution of pellets in the gastrointestinal tract due to their small size and larger surface, uniform drug absorption is facilitated which results in consistent and controlled pharmacological action.
+- A further reduction in inter-and intra-subject variability in drug absorption and clinical response is facilitated since the number of pellets per MUPS dosage form is much more than a conventional pellet-filled capsule and possibility of dose dumping(in stomach) and incomplete drug release is further minimized.
+
","Adult:
+
+- GERD (Gastroesophageal Reflux Disease): 20 mg once daily for 4 weeks.
+- Gastric ulcer: 20 mg once daily for 4-8 weeks; in severe cases Twice daily.
+- Duodenal ulcer: 20 mg once daily for 2-4 weeks; in severe cases Twice daily.
+- NSAID-induced ulceration: 20 mg once daily for 4-8 weeks.
+- Reflux esophagitis: 20 mg once daily for 4-8 weeks; in severe cases Twice daily.
+- H. pylori eradication (Omeprazole MUPS tablet with Amoxicillin and Clarithromycin or Metronidazole): 20 mg twice daily for 1 week.
+- Zollinger-Ellison Syndrome: 60 mg once daily; Usual maintenance, 20-120 mg daily.
+
+Children over 2 years old:
+
+- Acid regurgitation in GERD (Gastroesophageal Reflux Disease): 20 mg once daily for 2-4 week.
+- Reflux esophagitis: 20 mg once daily for 4-8 weeks.
+
","
+- Take the tablet before or after a meal.
+- Swallow the tablet whole with a glass of water. The tablet must not be chewed or crushed. OR
+- If the patients have trouble swallowing the tablets, put the tablet into a glass of water (Do not use other liquids). Stir the preparation until the tablets disintegrate. Then drink the liquid within 30 minutes. Stir the mixture just always before drinking.
+
","Omeprazole is metabolized through CYP2C19 . When starting or stopping treatment with Omeprazole should be taken into account potential interactions with medicines which are CYP2C19 metabolized.
","Omeprazole is contraindicated in those patients who have known hypersensitivity to any other components of the formulation.
",,"Not known to be harmful. Omeprazole can be used during pregnancy. Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used.
","Omeprazole tablet should be used carefully if the patient has severe liver dysfunction and severe renal impairment.
",,,,,"Store in a cool (below 25°C) and dry place, protected from light and moisture.
",10
+825,Omeprazole,omeprazole-825,https://medex.com.bd/attachments/XAhHO25vRn1NKkOtz860XiUSpVJhAA/omeprazole-prescribing-information,Proton Pump Inhibitor,Zollinger-Ellison syndrome,"Omeprazole is indicated for the treatment of-
+
+- Gastric and duodenal ulcer
+- NSAID-associated duodenal and gastric ulcer
+- As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
+- Gastro-esophageal reflux disease
+- Long-term management of acid reflux disease
... Read more
Omeprazole is indicated for the treatment of-
+
+- Gastric and duodenal ulcer
+- NSAID-associated duodenal and gastric ulcer
+- As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
+- Gastro-esophageal reflux disease
+- Long-term management of acid reflux disease
+- Acid-related dyspepsia
+- Severe ulcerating reflux esophagitis
+- Prophylaxis of acid aspiration during general anesthesia
+- Zollinger-Ellison syndrome
+- Helicobacter pylori-induced peptic ulcer.
+
","Proton Pump Inhibitor
","Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.
","Oral-
+
+- Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
+- NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
+- Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily.
+- Long-term management of acid reflux disease: 10-20 mg daily.
+- Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
+- Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
+- Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
+- Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
+- Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.
+
+
IV Injection-
+
+- Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
+- Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
+- Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.
+
","Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
","Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin. So, reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to the treatment. There is no evidence of an interaction of Omeprazole with theophylline, propranolol or antacids.
","Omeprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.
","Omeprazole is generally well tolerated. Nausea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.
","US FDA pregnancy category of Omeprazole is C. However, results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. There is no information available on the passage of Omeprazole into breast milk or its effects on the neonate. Breast-feeding should, therefore, be discontinued, if the use of Omeprazole is considered essential.
","When gastric ulcer is suspected, the possibility of gastric malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate the symptoms and delay diagnosis.
",,,,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",11
+835,Omega-3 Acid Ethyl Esters [Salmon Fish Oil],omega-3-acid-ethyl-esters-salmon-fish-oil-835,https://medex.com.bd/attachments/h6GEKaHR09AaOXV75NmMpCpyyCIDgG/omega-3-acid-ethyl-esters-salmon-fish-oil-prescribing-information,Other lipid regulating drugs,,"Omega-3 Acid Ethyl Esters is indicated as an adjunct to diet to reduce very high (>500mg/dl) triglyceride (TG) levels in adult patients and as an adjunct in secondary prevention in those who have had a myocardial infarction in the preceding 3 months. It is also indicated to help reduce the joint ... Read more
Omega-3 Acid Ethyl Esters is indicated as an adjunct to diet to reduce very high (>500mg/dl) triglyceride (TG) levels in adult patients and as an adjunct in secondary prevention in those who have had a myocardial infarction in the preceding 3 months. It is also indicated to help reduce the joint inflammation associated with mild arthritis, mood disorders & impulse control, age-related macular degeneration.
","Other lipid regulating drugs
","Omega-3-acid ethyl esters reduce triglyceride production by the liver but this mechanism is not well understood. Omega-3-acid ethyl esters inhibit acyl-CoA: 1,2-diacylglycerol acyltransferase, reducing triglyceride synthesis and increasing paroxysmal beta-oxidation, which increases fatty aside metabolism. Omega-3-acid ethyl esters also inhibit the release of fatty acids by competing for enzymes involved in the synthesis of triglycerides, increase triglyceride clearance by increasing the activity of lipoprotein lipase, and decrease production of VLDL-C.
","In hypertriglyceridaemia: it can be taken as a single dose of 4 capsules (4 gm) or 2 capsules (2 gm) twice daily.
In previously myocardial infarction patients: It can be taken 1 capsule (1 gm ) daily with food. Patients should be placed on an appropriate lipid lowering diet before receiving Omega-3 Acid Ethyl Esters and should continue this diet during treatment.
In joint inflammation associated with mild arthritis: The dose is 2.7 gm daily.
In mood disorders & impulse control and age-related macular degeneration: The dose is 1 capsule (1 gm) per day. Or, as directed by the registered physician.
",,"Patients receiving treatment with both Omega-3-acid ethyl esters and anticoagulants should be monitored periodically.
","It is contraindicated in patients who exhibit hypersensitivity to any component of this medication.
","Adverse events are rarely reported such as dyspepsia, nausea, constipation, gastritis, dizziness etc.
","Omega-3-acid ethyl esters should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether it is excreted in human milk. Caution should be exercised when Omega-3-acid ethyl esters are administered to a lactating mother.
","During therapy with omega-3-acid ethyl esters, LDL-C levels should be monitored and laboratory studies should be performed periodically to measure the patient's TG levels.
",,,,,"Store below 25°C in a dry & cool place.
",10
+824,Omalizumab,omalizumab-824,https://medex.com.bd/attachments/3m3pZ9etLK13f2S6amJOFqdsgScYFb/omalizumab-prescribing-information,Antihistamines anti-allergies & hypo-sensitisation,Nasal polyps,"Asthma: Omalizumab is indicated for adults and pediatric patients 6 years of age and older with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids ... Read more
Asthma: Omalizumab is indicated for adults and pediatric patients 6 years of age and older with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.
Nasal Polyps: Omalizumab is indicated for add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.
Chronic Spontaneous Urticaria (CSU): Omalizumab is indicated for the treatment of adults and adolescents 12 years of age and older with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
","Antihistamines anti-allergies & hypo-sensitisation
","Asthma and Nasal Polyps: Omalizumab inhibits the binding of IgE to the high-affinity IgE receptor (FcεRI) on the surface of mast cells, basophils, and dendritic cells, resulting in FcεRI down-regulation on these cells. In allergic asthmatics, treatment with omalizumab inhibits IgE-mediated inflammation, as evidenced by reduced blood and tissue eosinophils and reduced inflammatory mediators, including IL-4, IL-5, and IL-13.
Chronic Spontaneous Urticaria (CSU): Omalizumab binds to IgE and lowers free IgE levels. Subsequently, IgE receptors (FcεRI) on cells down-regulate. The mechanism by which these effects of omalizumab result in an improvement of CSU symptoms is unknown.
","For subcutaneous (SC) administration only. Divide doses of more than 150 mg among more than one injection site to limit injections to not more than 150 mg per site.
Asthma: omalizumab 75 to 375 mg SC every 2 or 4 weeks. Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). See the dose determination charts.
Nasal Polyps: omalizumab 75 to 600 mg SC every 2 or 4 weeks. Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). See the dose determination charts.
Chronic Spontaneous Urticaria: omalizumab 150 or 300 mg SC every 4 weeks. Dosing in CSU is not dependent on serum IgE level or body weight.
",,,"Omalizumab is contraindicated in patients with severe hypersensitivity reaction to Omalizumab or any ingredient of Omalizumab.
","Asthma: The most common adverse reactions (≥1% of patients) in clinical studies with adult and adolescent patients ≥12 years of age were arthralgia, pain (general), leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, and earache. In clinical studies with pediatric patients 6 to <12 years of age, the most common adverse reactions were nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bites, and epistaxis.
Nasal Polyps: The most common adverse reactions (≥3% of patients) in clinical studies with adult patients included the following: headache, injection site reaction, arthralgia, upper abdominal pain, and dizziness.
Chronic Spontaneous Urticaria: The most common adverse reactions (≥2% of patients) included the following: nausea, nasopharyngitis, sinusitis, upper respiratory tract infection, viral upper respiratory tract infection, arthralgia, headache, and cough.
","There are risks associated with poorly or moderately controlled asthma in pregnancy. There is no information regarding the presence of omalizumab in human milk or the effects on milk production. However, omalizumab is a human monoclonal antibody (IgG1 kappa), and immunoglobulin (IgG) is present in human milk in small amounts.
","
+- Anaphylaxis: Initiate omalizumab therapy in a healthcare setting prepared to manage anaphylaxis which can be life-threatening and observe patients for an appropriate period of time after administration.
+- Malignancy: Malignancies have been observed in clinical studies.
+- Acute Asthma Symptoms: Do not use for the treatment of acute bronchospasm or status asthmaticus.
+- Corticosteroid Reduction: Do not abruptly discontinue corticosteroids upon initiation of omalizumab therapy.
+- Eosinophilic Conditions: Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy, especially upon reduction of oral corticosteroids.
+- Fever, Arthralgia, and Rash: Stop omalizumab if patients develop signs and symptoms similar to serum sickness.
+
",,,,,"Omalizumab prefilled syringe should be shipped and stored under refrigerated conditions 2°C to 8°C in the original carton. Protect from direct sunlight. Omalizumab prefilled syringe can be removed from and placed back in the refrigerator if needed. The total combined time out of the refrigerator may not exceed 2 days. Do not use if the prefilled syringe is exposed to temperatures above 25°C. Do not freeze. Do not use if the syringe has been frozen.
",9
+823,Olopatadine Hydrochloride (Ophthalmic),olopatadine-hydrochloride-ophthalmic-823,https://medex.com.bd/attachments/n20UPff5XJaaYDiuzcjfdPr9E92oQd/olopatadine-hydrochloride-ophthalmic-01-ophthalmic-solution-prescribing-information,Ophthalmic Non-Steroid drugs,Rhinitis,"Olopatadine is indicated for the treatment of ocular itching associated with allergic conjunctivitis.
","Ophthalmic Non-Steroid drugs
","Olopatadine is an inhibitor of the release of histamine from the mast cell and a relatively selective histamine H1‐antagonist that inhibits the in vivo and in vitro type 1 immediate hypersensitivity reaction including inhibition of histamine induced effects on human conjunctival epithelial cells. Olopatadine is devoid of effects on alpha adrenergic, dopamine and muscarinic type 1 and 2 receptors. Following topical ocular administration in human, olopatadine was shown to have low systemic exposure.
","0.1% Sterile Eye Drops: One drop in each affected eye two times per day at an interval of 6 to 8 hours.
0.2% Sterile Eye Drops: One drop in the affected eye once a day.
0.7% Sterile Eye Drops: One drop in each affected eye once a day.
",,"May result in additive CNS depression with CNS depressants.
","Olopatadine Hydrochloride ophthalmic solution is contraindicated in persons with a known hypersensitivity to Olopatadine Hydrochloride.
","Headaches have been reported at an incidence of 7%. The following adverse experiences have been reported in less than 5% of patients: Asthenia, blurred vision, burning or stinging, cold syndrome, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, nausea, pharyngitis, pruritus, rhinitis, sinusitis, and taste perversion
","There are no adequate and well controlled studies in pregnant women. Because animal studies are not always predictive of human responses, this drug should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the fetus.
It is not known whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in the human breast milk. Nevertheless, caution should be exercised when Olopatadine Hydrochloride ophthalmic solution is administered to a nursing mother.
","Olopatadine HCl ophthalmic solution should not be used to treat contact lens related irritation. Patients who wear soft contact lenses should be instructed to wait at least ten minutes after instilling Olopatadine Hydrochloride ophthalmic solution before they insert their contact lenses.
","Geriatric Use: No overall differences in safety or effectiveness have been observed betweents.
","Symptoms: Drowsiness in adults and, initially, agitation and restlessness, followed by drowsiness in childn.
Management: Symptomatic or supportive treatment.
",,,"Store below 30° C in a cool and dry place protected from light. Keep out of reach of children. Do not touch the dropper tip to surfaces since this may contaminate the solution. Do not use after 30 days of first opening.
",12
+1334,Olopatadine Hydrochloride (Nasal Spray),olopatadine-hydrochloride-nasal-spray-1334,https://medex.com.bd/attachments/2GMKqA6OE7c0w9kaPudXXlN9FR4oyW/olopatadine-hydrochloride-nasal-spray-prescribing-information,Nasal Anti-histamine preparations,Seasonal allergic rhinitis,"Olopatadine Nasal Spray is an H1 receptor antagonist indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and children 6 years of age and older.
","Nasal Anti-histamine preparations
","Olopatadine, an antihistamine, works by blocking the action of histamine in the body, which reduces allergy symptoms. Olopatadine Hydrochloride treats sneezing, itching, runny nose, and other nasal symptoms of allergies. Olopatadine Nasal Spray contains 0.6% w/v Olopatadine (base) in a nonsterile aqueous solution with pH of approximately 3.7. After initial priming (5 sprays), each metered spray from the nasal applicator delivers 100 microliters of the aqueous solution containing 665 mcg of olopatadine Hydrochloride, which is equivalent to 600 mcg of Olopatadine (base). Olopatadine Nasal Spray also contains benzalkonium chloride (0.01%), dibasic sodium phosphate, edetate disodium, sodium chloride, hydrochloric acid and/or sodium hydroxide (to adjust pH), and purified water.
","Adults and Adolescents 12 years of age and older: Two sprays per nostril twice daily.
Children 6 to 11 years of age: One spray per nostril twice daily.
Administer Olopatadine Nasal Spray by the intranasal route only.
","How to use the Nasal Spray-
+
+- Shake the bottle gently and remove the dust cover.
+- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
+- Gently blow the nose to clear the nostrils.
+- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
+- Breathe out through your mouth.
+- Repeat the above steps in the same/ other nostril for consecutive doses.
+
+Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-
+
+- Remove the dust cover.
+- Gently pull off the nasal applicator.
+- Wash the applicator and dust cover in warm water.
+- Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
+- Gently push the applicator back on the top of the bottle and re-fix the dust cover.
+
","Interaction with other medications have not been investigated.
",,"A bitter taste in the mouth, nosebleeds, or irritation/soreness in the nose may occur. Drowsiness may rarely occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
","Pregnancy Category C. No adequate and well-controlled studies in pregnant women have been conducted. Olopatadine Nasal Spray should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.
Lactation: It is not known whether topical nasal administration could result in sufficient systemic absorption to produce detectable quantities in human breast milk. Olopatadine Nasal Spray should be used by nursing mothers only if the potential benefit to the patient outweighs the potential risks to the infant.
","Before initial use, Olopatadine Nasal Spray by releasing 5 sprays or until a fine mist appears. When Olopatadine Nasal Spray has not been used for more than 7 days, re-prime by releasing 2 sprays. Avoid spraying Olopatadine Nasal Spray into the eyes. Patients should be informed to avoid spraying Olopatadine Nasal Spray in their eyes.
",,"There have been no reported overdoses with Olopatadine Nasal Spray.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+570,Olmesartan Medoxomil + Hydrochlorothiazide,olmesartan-medoxomil-hydrochlorothiazide-570,https://medex.com.bd/attachments/Np41TIV7n2tFCU0jjE1m3sS1cxSPZj/olmesartan-medoxomil-hydrochlorothiazide-prescribing-information,Combined antihypertensive preparations,Hypertension,"Olmesartan Medoxomil & Hydrochlorothiazide combination is indicated for the treatment of hypertension.
","Combined antihypertensive preparations
","Angiotensin-II formed from angiotensin-I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT 1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT 1 receptor. Olmesartan does not inhibit ACE (kinase-I, the enzyme that converts angiotensin-I to angiotensin-II and degrades bradykinin).
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing the excretion of Sodium and Chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume with consequent increases in plasma renin activity, increases Aldosterone secretion & urinary Potassium loss and decreases serum Potassium. The renin-aldosterone link is mediated by angiotensin-II. So, co-administration of an angiotensin-II receptor antagonist tends to reverse the potassium loss associated with these diuretics.
","Hypertension: The usual starting dose is 20/12.5 mg one tablet once daily. Dosing should be individualized. Depending on the blood pressure response, the dose may be titrated at intervals of 2-4 weeks to two tablets 40/25 once daily.
",,"Olmesartan: No significant drug interactions were reported in studies in which Olmesartan Medoxomil was co-administered with hydrochlorothiazide, digoxin or warfarin in healthy volunteers. Olmesartan Medoxomil is not metabolized by the cytochrome P450 system and has no effects on P450 enzymes; thus, interactions with drugs that inhibit, induce or are metabolized by those enzymes are not expected.
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics:
+
+- Alcohol, Barbiturates or Narcotics: Potentiation of orthostatic hypotension may occur.
+- Antidiabetic drugs (oral agents and Insulin): Dosage adjustment of the antidiabetic drug may be required.
+- Other antihypertensive drugs: Additive effect.
+- Corticosteroids, ACTH.
+- Lithium.
+
","The combination of Olmesartan and Hydrochlorothiazide is contraindicated in patients who are hypersensitive to any component of this product. Because of the Hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
","The common side-effects are nausea, headache, dizziness, hyperuricemia, upper respiratory tract infection and urinary tract infection. Other adverse effects are chest pain, back pain, peripheral edema, abdominal pain, dyspepsia, gastroenteritis, diarrhea.
","Safety and effectiveness in nursing mother & pregnancy have not been established. The drug should be discontinued during these conditions.
","
+- Periodic determination of serum electrolytes should be performed at appropriate intervals to detect possible electrolyte imbalance like hypokalemia, hyponatremia and hypochloremic alkalosis.
+- Hyperuricemia may occur in certain patients receiving thiazide therapy.
+- Impaired renal function.
+
","Renal Impairment Patients: The usual regimens of therapy with this may be followed provided the patient's creatinine clearance is >30 ml/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. So, this preparation is not recommended.
Hepatic Impairment Patients: No dosage adjustment is necessary with hepatic impairment.
Paediatric use: Safety and effectiveness in paediatric patients have not been established.
Geriatric use: Clinical studies of Olmesartan and Hydrochlorothiazide combination did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious.
","Olmesartan: Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia. Supportive treatment should be instituted.
Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration) resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.
",,,"Store in a cool and dry place, protect from light and moisture. Keep out of the reach of children.
",12
+822,Olmesartan Medoxomil,olmesartan-medoxomil-822,https://medex.com.bd/attachments/YQk2wj8hjX6A003Ea8N70mgLkBVuW5/olmesartan-medoxomil-prescribing-information,Angiotensin-ll receptor blocker,Hypertension,"Olmesartan Medoxomil is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
","Angiotensin-ll receptor blocker
","Angiotensin-II formed from angiotensin-I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT 1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT 1 receptor. Olmesartan does not inhibit ACE (kinase-I, the enzyme that converts angiotensin-I to angiotensin-II and degrades bradykinin).
","Dosage must be individualized. The usual recommended starting dose of Olmesartan is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmesartan may be increased to 40 mg. Doses above 40 mg do not appear to have a greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.
No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
",,"With medicine: No significant drug interactions were reported in which Olmesartan was co-administered.
With food & others: Food does not affect the bioavailability of Olmesartan.
","Olmesartan is contraindicated in patients who are hypersensitive to any component of this product.
","Common: The most common side effects include Back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis, and sinusitis.
Rare: Chest pain, peripheral edema, arthritis.
","Pregnancy: When pregnancy is detected, discontinue this product as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
","As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with olmesartan medoxomil. In patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results may be anticipated in patients treated with olmesartan medoxomil.
","Paediatric use: Safety and effectiveness in paediatric patients have not been established.
","Symptoms: There is no experience of overdose with Olmesartan. The most likely effects of olmesartan medoxomil overdosage are hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurred.
Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.
",,,"Store in cool & dry place below 30ºC, protect from light & moisture. Keep out of the reach of children.
",12
+1399,Olaparib,olaparib-1399,https://medex.com.bd/attachments/u86RxuLIU6E56am8j0QvcexomyiyYo/olaparib-prescribing-information,Targeted Cancer Therapy,Ovarian cancer,"Breast Cancer: Olaparib is indicated as monotherapy for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have previously been treated with chemotherapy ... Read more
Breast Cancer: Olaparib is indicated as monotherapy for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have progressed on or be considered inappropriate for endocrine therapy. Germline BRCA mutation must be confirmed before Olaparib treatment is initiated.
Ovarian Cancer: Olaparib is indicated as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed (PSR) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to platinumbased chemotherapy.
","Targeted Cancer Therapy
","Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3. PARP enzymes are involved in normal cellular homeostasis, such as DNA transcription, cell cycle regulation, and DNA repair. Olaparib has been shown to inhibit growth of select tumor cell lines in vitro and decrease tumor growth in mouse xenograft models of human cancer both as monotherapy or following platinum-based chemotherapy. Increased cytotoxicity and anti-tumor activity following treatment with olaparib were noted in cell lines and mouse tumor models with deficiencies in BRCA. In vitro studies have shown that olaparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complex, resulting in disruption of cellular homeostasis and cell death.
","There is a risk of medication errors between Olaparib tablets and Olaparib capsules. In order to minimize this risk, check the bottle labels to ensure that the drug being prepared and dispensed is Olaparib tablets and not Olaparib capsules. Prescribers should specify the formulation and dosage of Olaparib on each prescription.
The recommended total daily dose of Olaparib tablets is 600 mg, taken as two 150 mg tablets twice daily. The 100 mg tablet is available for dose reduction.
For treatment of ovarian cancer: Patients should start treatment with Olaparib no later than 8 weeks after completion of their final dose of the platinum-containing regimen. Patients should have recovered from prior hematologic toxicities prior to starting Olaparib therapy (hemoglobin, platelet, and neutrophil levels should be ≤ CTCAE grade 1).
It is recommended that Olaparib treatment be continued until progression of the underlying disease or unacceptable toxicity. Olaparib should not be given in combination with other anti cancer therapy. Grapefruit or other similar fruit juices that are known to inhibit CYP3A should not be consumed while taking Olaparib.
",,"Clinical studies of olaparib in combination with other anti-cancer agents, including DNA damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity. The recommended Olaparib monotherapy dose is not suitable for combination with myelosuppressive anti-cancer agents. Olaparib is predominantly metabolised by CYP3A. Co-administered CYP3A inhibitors or inducers may respectively increase or decrease olaparib plasma concentration.
","Olaparib is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation.
","The most common serious adverse reaction reported was anemia (2.4% olaparib vs 2.2% chemotherapy). The following serious ADRs were reported in one patient each: dermatitis allergic, neutrophil count decreased and platelet count decreased. The proportion of patients who permanently discontinued Olaparib due to adverse events was 4.9% in the Olaparib arm compared with 7.7% in the chemotherapy arm. Anemia and platelet count decrease were the only adverse reactions leading to discontinuation of Olaparib in more than one patient.
","Pregnancy: Olaparib can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. Olaparib wasteratogenic and caused embryo-fetal toxicity in rats at exposures below those in patients receiving the recommended human dose of 400 mg twice daily. If this drug is used during pregnancy, or if a patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for loss of the pregnancy.
Nursing Mothers: It is not known whether olaparib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from olaparib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): occurred in patients exposed to Olaparib, and the majority of reports were fatal. Monitor patients for hematological toxicity at baseline and monthly thereafter. Discontinue if MDS/AML is confirmed.
Pneumonitis: occurred in patients exposed to Olaparib, and some cases were fatal. Interrupt treatment if pneumonitis is suspected. Discontinue if pneumonitis is confirmed.
Embryo-Fetal Toxicity: Olaparib can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception
","Pediatric Use: The safety and efficacy of Olaparib has not been established in pediatric patients.
","There is no specific treatment in the event of Olaparib overdose, and symptoms of overdose are not established. In the event of an overdose, physicians should follow general supportive measures and should treat symptomatically.
",,,"Store in a dry place below 30°C, protect from light. Keep out of the reach of children.
",12
+821,Olanzapine,olanzapine-821,https://medex.com.bd/attachments/CDfLAdZrDNViFHt2LecVnltq9MVYKv/olanzapine-prescribing-information,Atypical neuroleptic drugs,Unipolar and bipolar depression,"Olanzapine is indicated for the acute and maintenance treatment of schizophrenia and related psychoses where positive symptoms (e.g. delusions, hallucinations, disordered thinking, hostility and suspiciousness) and/or negative symptoms (e.g. flattened affect, emotional and social withdrawal, poverty ... Read more
Olanzapine is indicated for the acute and maintenance treatment of schizophrenia and related psychoses where positive symptoms (e.g. delusions, hallucinations, disordered thinking, hostility and suspiciousness) and/or negative symptoms (e.g. flattened affect, emotional and social withdrawal, poverty of speech) are prominent. Olanzapine is indicated for the treatment of acute manic or mixed episodes in bipolar disorder, with or without psychotic features and with or without a rapid cycling course
","Atypical neuroleptic drugs
","Olanzapine is an antipsychotic agent and has affinities for serotonin 5HT2A/2C, 5HT3, 5HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α1 adrenergic; and histamine H1 receptors. The mechanism of action of Olanzapine, as with other drugs having efficacy in schizophrenia, is unknown. However, it has been proposed that this drug’s efficacy in schizophrenia is mediated through a combination of dopamine and serotonin type 2 (5HT2) antagonism. Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours. The absorption is not affected by food. Olanzapine is not mutagenic or clastogenic as well as not carcinogenic.
","Schizophrenia, combination therapy for Mania, Bipolar Disorder: The initial dose is 5-10 mg once daily. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. Dosage greater than 10 mg daily only after reassessment. Maximum dose is 20 mg daily.
Monotherapy for Mania: Initially 15 mg once daily. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. Dosage greater than 15 mg only after reassessment. Maximum dose is 20 mg daily.
","Olanzapine can be given without regard to meals. Gradual tapering of the dose should be considered while discontinuing Olanzapine.
","Olanzapine may antagonize the effects of levodopa and dopamine agonists. Drugs that induce CYP1A2 or glucoronyl transferase enzymes e.g, Omeprazole and Rifampicin, may increase Olanzapine clearance. Inhibitors of CYP1A2 may potentially inhibit Olanzapine elimination. Carbamazepine may increase the clearance of Olanzapine. Concomitant administration of activated charcoal reduces the oral bioavailability of Olanzapine by 50-60%. Caution should be taken when Olanzapine is administered with centrally acting drugs and alcohol.
","Olanzapine is contraindicated in those patients with a known hypersensitivity to any ingredient of the product as well as in patients with known risk for narrow-angle glaucoma.
","Very common undesirable effects are somnolence and weight gain. Besides increased appetite, elevated glucose levels, elevated triglyceride levels, dizziness, akathisia, Parkinson's disease, dyskinesia, orthostatic hypotension, mild and transient anticholinergic effects including constipation and dry mouth, asthenia, edema and photosensitivity reaction etc. may be observed.
","Olanzapine should be used in pregnancy only if the potential benefits justify the potential risk to the foetus. So, patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with Olanzapine. There is no report to show teratogenecity. Patients should not breast feed if they are taking Olanzapine.
","Olanzapine should be used cautiously in patients who have a history of seizures or have conditions associated with seizures. Olanzapine should be used cautiously in patients with low leukocyte and/or neutrophil counts for any reason, drug induced bone marrow depression/toxicity caused by radiation therapy or chemotherapy, hypereosinophilic conditions, impaired hepatic function, and patients using hepatotoxic medicines, centrally acting drug and medicines know to increase QT interval, especially in the elderly. Patients should be cautioned about operating hazardous machinery, including motor vehicles.
","Children: Olanzapine has not been studied in subjects under 18 years of age.
Elderly patients (age 65 and over): starting dose 5 mg/day
Patients with hepatic, renal impairment: starting dose 5 mg/day
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+1645,Ofloxacin + Clotrimazole + Beclomethasone + Lidocaine,ofloxacin-clotrimazole-beclomethasone-lidocaine-1645,,Anti-fungal or anti-bacterial ear drops,Fungal eye infections,"This ear drop is indicated for the treatment of superficial bacterial and fungal infections of the external auditory canal and the middle ear, caused by organisms susceptible to the action of Ofloxacin and Clotrimazole.
","Anti-fungal or anti-bacterial ear drops
","It is a combination of an antibacterial, an antifungal, an anti-inflammatory and a topical local anesthetic agent. This ear drop has been specially formulated to maintain the natural environment of the external ear canal.
Ofloxacin is a fluoroquinolone that has a broad spectrum of activity against otic pathogens without ototoxicity. Hence Ofloxacin is preferred to Aminoglycosides for any application within the middle ear space. Ofloxacin exerts antibacterial activity by inhibiting DNA gyrase of bacteria. Ofloxacin has been shown to be active against the following organisms responsible for otic infections: Gram-positive: Staphylococcus aureus, Streptococcus pneumoniae. Gram-negative: Escherichia coli, Haemophilus influenzae, Moraxella catarrhalis, Proteus mirabilis, Pseudomonas aeruginosa.
Clotrimazole is a synthetic imidazole derivative, which is a broad-spectrum antifungal agent that exerts fungicidal activity against fungi responsible for superficial mycotic infections affecting the outer or middle ear including Candida, Microsporum & Trichophyton. Clotrimazole inhibits Cytochrome P-450 synthesis of Ergosterol, which decreases fungal cell wall integrity thus inhibits fungal growth. Clotrimazole also has activity against certain bacteria such as Streptococci and Staphylococci. The antibacterial effect of Clotrimazole is advantageous to treat mixed bacterial-fungal infections.
Beclomethasone Dipropionate is a potent steroid as compared with other topical corticosteroids. Beclomethasone like other topical corticosteroids, has anti-inflammatory, antipruritic, and vasoconstrictive properties. It induces phospholipase A2 and sequentially inhibits the release of arachidonic acid, thereby depressing the formation, release, and activity of prostaglandins, leukotrienes, and other inflammatory mediators.
Lidocaine Hydrochloride is a topical local anesthetic which helps to reduce pain and stinging in the ear.
","
+- Adults & Children: Instill 2-5 drops three to four times daily into the affected ear for 7-14 days.
+- Otitis Externa with intact tympanic membrane: From age 06 months & older.
+- Chronic Suppurative Otitis Media with perforated tympanic membrane: 12 years & older.
+
+Instruction to use: To apply, tilt head to one side so that the ear is facing up. Then gently pull the ear lobe up & backward in case of adults and children older than 3 years. In case of pediatric patients gently pull the ear lobe down & backward.
",,,"This ear drop is contraindicated in patients with sensitive to Ofloxacin or other quinolone, or to any of the components of this medications. It is contra-indicated in viral infections of the ear.
","The systemic side-effects are not common with this ear drops. The following adverse reactions may be observed when using this product: itching, burning, irritation, dryness, earache, headache, vertigo, dizziness, redness, folliculitis, hypertrichosis, acne form eruptions and hypopigmentation.
","Safety during pregnancy or lactation has not been established. It is not known whether the active substances pass into breast milk when applied topically. Therefore, the potential benefit of this product during pregnancy or lactation, should be weighed against possible hazard to the fetus or the nursing infant.
","
+- If a favorable response does not occur in one week, discontinue the use of this preparation and obtain cultures to guide further treatment.
+- As with other anti-infective preparations, prolonged use may result in overgrowth of nonsusceptible organisms.
+- If local irritation or sensitization occurs, discontinue this preparation and institute appropriate therapy.
+- If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.
+- Not for Ophthalmic use. Not for injection.
+
",,,,,"Keep away from light and moisture, store below 25°C.
",9
+836,Ofloxacin (Oral & Injection),ofloxacin-oral-injection-836,https://medex.com.bd/attachments/69ikLLeU3CDcfXZdR0cBZjyj2NqVgA/ofloxacin-oral-injection-prescribing-information,Aural Anti-bacterial preparations,Uncomplicated cystitis,"Ofloxacin are indicated for the treatment of adults with mild to moderate infections caused by susceptible strains.
+
+- Lower Respiratory Tract: Acute bacterial exacerbation of chronic bronchitis lung abscess, pneumonia.
+- Gastrointestinal Tract: Enteric fever, shigellosis.
... Read more
Ofloxacin are indicated for the treatment of adults with mild to moderate infections caused by susceptible strains.
+
+- Lower Respiratory Tract: Acute bacterial exacerbation of chronic bronchitis lung abscess, pneumonia.
+- Gastrointestinal Tract: Enteric fever, shigellosis.
+- Multi-drug-resistant Tuberculosis.
+- Skin and skin structures: Uncomplicated skin and skin structure infections.
+- Sexually Transmitted Diseases: Acute, Uncomplicated urethral and cervical gonorrhoea. Nongonococcal urethritis and cervicitis. Mixed infections of the urethra and cervix.
+- Urinary tract: Uncomplicated Urinary Tract Infections, Complicated urinary tract infections.
+
","4-Quinolone preparations, Aural Anti-bacterial preparations
","Ofloxacin is a synthetic 4-fluoroquinolone antibacterial agent with bactericidal activity against a wide range of Gram-negative and Gram-positive organisms. Ofloxacin is thought to exert bactericidal effect by inhibiting DNA gyrase, an essential enzyme that is a critical catalyst in the duplication, transcription and repair of bacterial DNA.
","Intravenous (Adult):
+
+- Skin and soft tissue infections: 400 mg bid infused over at least 1 hr.
+- Complicated urinary tract infections: 200 mg daily by infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.
+- Lower respiratory tract infections, Septicaemia: 200 mg bid by infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.
+
+
Oral (Adult):
+
General dosage recommendations: The dose of ofloxacin is determined by the type and severity of the infection. The dosage range for adults is 200 mg to 800 mg daily. Up to 400 mg may be given as a single dose, preferably in the morning, larger doses should be given as two divided doses. Ofloxacin tablets should be swallowed with liquid; they should not be taken within two hours of intake of magnesium/aluminium containing antacids or iron preparations since reduction of absorption of ofloxacin can occur.
+
+- Enteric fever: For adults 200 mg, every 12 hours, for 5 days. For children 15 mg/kg/day in 2 divided doses for 3 days.
+- Shigellosis: 400 mg single dose.
+- Multi-drug-resistant tuberculosis: 400 mg twice daily along with conventional anti-tuberculosis drugs.
+- Lower respiratory tract infection: 400 mg daily, increasing, if necessary, to 400 mg twice daily.
+- Uncomplicated Urinary Tract Infections: A single dose of 200/400 mg.
+- Uncomplicated urethral and cervical gonorrhoea: A single dose of 400 mg.
+- Non-gonococcal urethral and cervicitis: 400 mg daily in single or divided doses.
+- Complicated Urinary Tract Infection: 200/400 mg/day for 7 days.
+
+
Children: Ofloxacin is usually not indicated for use in children or growing adolescents.
Elderly: No adjustment of dosage is required in the elderly.
","May be taken with or without food. Avoid antacids or supplements containing Fe or Zn within 2 hr before or after ofloxacin. Ensure adequate hydration.
","Antacids containing magnesium, aluminium or calcium may decrease absorption of ofloxacin. Iron or Zinc may decrease oral absorption of ofloxacin.
","Ofloxacin should not be used in-patients with known hypersensitivity to 4-fluoroquinolone antibacterials. It is contraindicated in-patients with a history of epilepsy or with a lowered seizure threshold. Ofloxacin is usually contraindicated in children or growing adolescents and in pregnant or breast feeding women.
","Ofloxacin is generally well tolerated and clinical side-effects of ofloxacin has been quite low. Among the adverse effects gastrointestinal and central nervous systems' reactions are common. Nausea, rash, vomiting, abdominal pain, diarrhoea and gastrointestinal distress are the gastrointestinal adverse effects. Common central nervous system reactions are headache, dizziness and insomnia.
","The safety of ofloxacin during pregnancy has not been established. Ofloxacin may enter breast milk but data are not available.
","Patients being treated with Ofloxacin should not expose themselves unnecessarily to strong sunlight and should avoid UV rays. Caution is recommended if the drug is to be used in psychotic patients or in-patients with a history of psychiatric disease.
","Renal Impairment:
+
+- CrCl <20 and patients on haemodialysis or peritoneal dialysis: 100 mg 24 hrly following usual initial dose.
+- CrCl 20-50: Reduce dose by half 24 hrly following usual initial dose.
+
+Hepatic Impairment:Severe: Reduce dose. Max: 400 mg daily
","Symptoms: Confusion, dizziness, impairment of consciousness, convulsive seizures, GI reactions (e.g. nausea, mucosal erosions).
Management: Symptomatic and supportive treatment. Remove any unabsorbed drug by gastric lavage or admin of adsorbants and Na sulfate. Antacids are recommended for protection of gastric mucosa. Elimination may be increased by forced diuresis.
",,,"Store between 15-30° C. Protect from light.
",13
+1333,Ofloxacin (Ophthalmic),ofloxacin-ophthalmic-1333,https://medex.com.bd/attachments/two02ekXsRQq3r2NM253BRAyoYfJQZ/ofloxacin-ophthalmic-prescribing-information,Ophthalmic antibacterial drugs,Otitis externa,"Eye: It is indicated for the treatment of external ocular infections such as acute & sub-acute conjunctivitis, keratitis, kerato-conjunctivitis, blepharo-conjunctivitis, blepharitis, corneal ulcer and pre-operative prophylaxis in ocular surgery.
Ear: ... Read more
Eye: It is indicated for the treatment of external ocular infections such as acute & sub-acute conjunctivitis, keratitis, kerato-conjunctivitis, blepharo-conjunctivitis, blepharitis, corneal ulcer and pre-operative prophylaxis in ocular surgery.
Ear: It is indicated for the treatment of external ear infections (otitis externa) and certain middle ear infections (otitis media).
","4-Quinolone preparations, Ophthalmic antibacterial drugs
","Ofloxacin is a synthetic 4-fluoroquinolone antibacterial agent with bactericidal activity against a wide range of Gram-negative and Gram-positive organisms. Ofloxacin is thought to exert bactericidal effect by inhibiting DNA gyrase, an essential enzyme that is a critical catalyst in the duplication, transcription and repair of bacterial DNA.
","Eye: Instill 1 drop in the affected eye(s) every 2 to 4 hours for the first two days and then 4 times daily. The length of treatment should not exceed ten days.
Ear: Instill 1-2 drops in the affected ear(s) twice daily or as needed.
",,,"It is contraindicated in patients who are hypersensitive to Ofloxacin or any other component of this preparation.
","Eye: Transient ocular irritation, burning, stinging, redness, itching or photophobia have been reported.
Ear: Mild irritation or mild discomfort in the ear may occur. Symptoms of an allergic reaction include rash, itching, swelling or trouble breathing.
","Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether Ofloxacin is excreted in human milk. Cautions should be taken when Ofloxacin eye & ear drops is administered during lactation.
","Prolonged use of eye drops & ear drops may result in overgrowth of non-susceptible organisms and secondary infection respectively.
",,,,,,8
+820,Octreotide Acetate,octreotide-acetate-820,https://medex.com.bd/attachments/2iW205Azn07gGvcyjIXDzvcGE85uAy/octreotide-acetate-prescribing-information,Growth hormone antagonist,Variceal haemorrhage,"Acromegaly: Octreotide acetate injection is indicated to reduce blood levels of growth hormone and IGF-I (somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally ... Read more
Acromegaly: Octreotide acetate injection is indicated to reduce blood levels of growth hormone and IGF-I (somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. The goal is to achieve normalization of growth hormone and IGF-I (somatomedin C) levels. In patients with acromegaly, Octreotide acetate injection reduces growth hormone to within normal ranges in 50% of patients and reduces IGF-I (somatomedin C) to within normal ranges in 50% to 60% of patients. Since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with Octreotide acetate injection to reduce blood levels of growth hormone and IGF-I (somatomedin C) offers potential benefit before the effects of irradiation are manifested.
Improvement in clinical signs and symptoms or reduction in tumor size or rate of growth were not shown in clinical trials performed with Octreotide acetate injection; these trials were not optimally designed to detect such effects.
Carcinoid Tumors: Octreotide acetate injection is indicated for the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease.
Octreotide acetate injection studies were not designed to show an effect on the size, rate of growth or development of metastases.
Vasoactive Intestinal Peptide Tumors (VIPomas): Octreotide acetate injection is indicated for the treatment of the profuse watery diarrhea associated with VIP-secreting tumors. Octreotide acetate injection studies were not designed to show an effect on the size, rate of growth or development of metastases.
","Growth hormone antagonist
","Octreotide is a synthetic analogue of somatostatin which acts by suppressing basal and stimulated secretion of growth hormone (GH). It also suppresses LH response to gonadotrophin-releasing hormone and reduces the secretion of gastrin, vasoactive intestinal peptide (VIP), insulin, glucagon, secretin, motilin and pancreatic polypeptide.
","Intramuscular-Acromegaly:
+
+- Adult: Following initial control with SC therapy: As a depot preparation, initially 20 mg every 4 wk. Adjust if required after 3 mth to 10-30 mg every 4 wk. Max: 40 mg every 4 wk.
+
+
Intravenous-Variceal haemorrhage in patients with cirrhosis:
+
+- Adult: As continuous IV infusion: 25 mcg/hr for 48 hr (up to 5 days in patients at high risk of re-bleeding).
+- Child: ≥1 mth: 1 mcg/kg/hr (up to 50 mcg/hr); given as continuous IV infusion. Higher doses may be needed initially, reduce dose gradually over 24 hr until bleeding has stopped.
+
+
Subcutaneous-Prophylaxis of complications following pancreatic surgery:
+
+- Adult: 100 mcg tid of a rapid-acting preparation given for 7 consecutive days, starting at least 1 hr before operation.
+
+
Subcutaneous-Acromegaly:
+
+- Adult: Initially 50 mcg tid, increased as necessary to usual dose 100-200 mcg tid. Max: 500 mcg tid.
+
+
Subcutaneous-Secretory neoplasms:
+
+- Adult: Initially, 50 mcg 1-2 times daily, increased gradually to up to 600 mcg daily in 2-4 divided doses according to response. Continued treatment is not recommended if there is no benefit within a wk of starting treatment for carcinoid tumour. Initial dose may be given via IV admin of a rapid response is required.
+
+
Subcutaneous-HIV-associated diarrhoea:
+
+- Adult: Initial dose 100 mcg tid. If symptoms are not controlled after 1 wk, increase dose to 250 mcg tid, if still not effective after 1 wk stop therapy.
+
",,"Dosage adjustment of concurrent therapy may be necessary with calcium channel blockers, oral hypoglycaemics, β-blockers, diuretics. May increase concentration of bromocriptine.
","Hypersensitivity
","Local pain, stinging, tingling at site of inj; anorexia, nausea, vomiting, abdominal pain, bloating, flatulence, loose stools, steatorrhoea; biliary tract abnormalities. Hypoglycaemia and hyperglycaemia, hypothyroidism, cardiac conduction abnormalitles, pancreatitis.
","Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
","Renal disease; risk of gall bladder disease; DM; hypothyroidism. Pregnancy, lactation, children, elderly. Monitor levels of vitamin B12 during long term therapy.
","Renal Impairment: Dosage may need to be reduced in severe renal impairment requiring dialysis.
",,,,"Store at 2-8° C. Stable at room temperature for up to 14 days.
",11
+1426,Obinutuzumab,obinutuzumab-1426,,Anti neoplastic preparations,Follicular lymphoma,"Chronic Lymphocytic Leukemia (CLL): Obinutuzumab in combination with chlorambucil is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia.
Follicular Lymphoma (FL): Obinutuzumab in combination with chemotherapy, followed ... Read more
Chronic Lymphocytic Leukemia (CLL): Obinutuzumab in combination with chlorambucil is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia.
Follicular Lymphoma (FL): Obinutuzumab in combination with chemotherapy, followed by Obinutuzumab maintenance is indicated for the treatment of patients with previously untreated follicular lymphoma. Obinutuzumab in combination with bendamustine, followed by Obinutuzumab maintenance, is indicated for the treatment of patients with FL who did not respond to, or who progressed during or after treatment with rituximab or a rituximab-containing regimen.
","Anti neoplastic preparations
","Obinutuzumab is a monoclonal antibody that targets the CD20 antigen expressed on the surface of pre-B and mature B lymphocytes. Upon binding to CD20, obinutuzumab mediates B-cell lysisthrough (1) engagement of immune effector cells (2) by directly activating intracellular death signaling pathways (direct cell death), and/or (3) activation of the complement cascade. The immune effector cell mechanisms include antibody-dependent cellular cytotoxicity (ADCC) and antibodydependent cellular phagocytosis.
As an antibody with reduced fucose content, obinutuzumab induces greater ADCC activity than rituximab in vitro using human cancer cell lines. Obinutuzumab also demonstrated an increased ability to induce direct cell death when compared to rituximab. Obinutuzumab binds to FcγRIII using purified proteins with a higher affinity than rituximab. Obinutuzumab and rituximab bind with similar affinity to overlapping epitopes on CD20.
",,,"No formal drug-drug interaction studies have been performed, although limited drug interaction sub-studies have been undertaken for Obinutuzumab with bendamustine, CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone), FC (fludarabine, cyclophosphamide) and chlorambucil. Co administration with Obinutuzumab had no effect on the pharmacokinetics of bendamustine, FC or the individual components of CHOP; in addition, there were no apparent effects of bendamustine, FC, chlorambucil or CHOP on the pharmacokinetics of Obinutuzumab. A risk for interactions with concomitantly used medicinal products cannot be excluded.
","Obinutuzumab is contraindicated in patients with a known hypersensitivity to obinutuzumab or to any of the excipients.
","The following adverse reactions are discussed in greater detail in other sections of the label:
+
+- Hepatitis B reactivation
+- Progressive multifocal leukoencephalopathy
+- Infusion reactions
+- Tumor lysis syndrome
+- Infections
+- Neutropenia
+- Thrombocytopenia
+
","Pregnancy: Obinutuzumab is likely to cause fetal B-cell depletion based on findings from animal studies and the drug’s mechanism of action. There are no data with Obinutuzumab use in pregnant women to inform a drug-associated risk. Monoclonal antibodies are transferred across the placenta. In animal reproduction studies, weekly intravenous administration of obinutuzumab to pregnant cynomolgus monkeys from day 20 of pregnancy until parturition which includes the period of organogenesis at doses with exposures up to 2.4 times the exposure at the clinical dose of 1000 mg monthly produced opportunistic infections and immune complex mediated hypersensitivity reactions. No embryo-toxic or teratogenic effects were observed in the monkeys. Consider the potential risk to the fetus when prescribing Obinutuzumab to a pregnant woman.
The background risk of major birth defects and miscarriage for the indicated population is unknown; however, the estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.
Lactation: There is no information regarding the presence of Obinutuzumab in human milk, the effects on the breastfed child, or the effects on milk production. However, low levels of obinutuzumab were present in the milk of lactating cynomolgus monkeys [see Pregnancy]. Human IgG is known to be present in human milk. Published data suggest that antibodies in breast milk do not enter the neonatal and child circulations in substantial amounts. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Obinutuzumab and any potential adverse effects on the breastfed child from Obinutuzumab or from the underlying maternal condition.
","In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered product should be clearly recorded (or stated) in the patient file.
","Pediatric Use: The safety and efficacy of Obinutuzumab in children below 18 years of age have not been established.
Geriatric Use:
+
+- Chronic Lymphocytic Leukemia (CLL): In the pivotal study in CLL, 46% (156 out of 336) of patients treated with Obinutuzumab plus chlorambucil were 75 years old or older (median age was 74 years). These patients experienced more serious adverse events and adverse events leading to death than patients <75 years of age. No significant differences in efficacy were observed between patients ≥75 years of age and those <75 years of age
+- Non-Hodgkin Lymphoma (NHL): In the pivotal studies in NHL, patients 65 years old or older experienced more serious adverse events, and adverse events leading to withdrawal or death than patients <65 years of age. No clinically meaningful differences in efficacy were observed.
+
",,,,"Store vials in a refrigerator at 2°C-8°C. Keep vial in the outer carton in order to protect from light. Do not freeze. Do not shake.
",10
+853,Oxytetracycline + Polymixin B Sulphate,oxytetracycline-polymixin-b-sulphate-853,https://medex.com.bd/attachments/V2eV817iiPz6uJ1575K0gQD7qQd0oy/oxytetracycline-polymixin-b-sulphate-prescribing-information,Topical Antibiotic preparations,Superficial skin infections,"This is indicated for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline and polymyxin-sensitive organisms, including infections due to streptococci, rickettsiae, E. coli, and A. aerogenes, such as conjunctivitis, keratitis, pink eye, corneal ulcer, blepharitis ... Read more
This is indicated for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline and polymyxin-sensitive organisms, including infections due to streptococci, rickettsiae, E. coli, and A. aerogenes, such as conjunctivitis, keratitis, pink eye, corneal ulcer, blepharitis in dogs, cats, cattle, sheep, and horses; ocular infections due to secondary bacterial complications of distemper in dogs, and bacterial inflammatory conditions which may occur secondary to other infectious diseases in the above species.
","Topical Antibiotic preparations
","Oxytetracycline inhibits cell growth by inhibiting translation. It binds to the 30S ribosomal subunit and prevents the amino-acyl tRNA from binding to the A site of the ribosome. The binding is reversible in nature. Oxytetracycline is lipophilic and can easily pass through the cell membrane or passively diffuses through porin channels in the bacterial membrane.
The broad-spectrum effectiveness of this ointment against both gram-positive and gram-negative organisms is enhanced by the particular effectiveness of polymyxin B against infections associated with gram-negative organisms, especially those due to Pseudomonas aeruginosa, where polymyxin B is the antibiotic of choice. In addition, there is evidence to indicate that polymyxin B sulfate possesses some antifungal activity.
","Oxytetracycline Hydrochloride and Polymyxin B Sulfate Ophthalmic Ointment should be administered topically to the eye 2-4 times daily.
",,,,"All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no common side effects have been reported with this product. Seek medical attention right away if any of these severe side effects occur: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); eye swelling or redness.
","If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using oxytetracycline or polymyxin b sulfate ointment while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use oxytetracycline or polymyxin b sulfate ointment, check with your doctor. Discuss any possible risks to your baby.
","Serious, life threatening, hypersensitivity (anaphylactic) reactions have been reported in some cats following application of antibiotic ophthalmic preparations. If your cat has swelling of the face, itching, appears weak, vomits, or has difficulty breathing within 4 hours of application you should discontinue treatment and contact your veterinarian immediately. The use of oxytetracycline and other antibiotics may result in an overgrowth of resistant organisms such as Monilia, staphylococci, and other species of bacteria. If new infections due to nonsensitive bacteria or fungi appear during therapy, appropriate measures should be taken.
",,,,,"Store at controlled room temperature between 20° to 25°C
",8
+851,Oxytetracycline,oxytetracycline-851,https://medex.com.bd/attachments/pKkv5qRkIm0uytre2hMRGIxlrqwVhl/oxytetracycline-prescribing-information,Tetracycline group of drugs,Uncomplicated gonorrhoea,"Oxytetracycline is indicated in-
+
+- Respiratory tract infections
+- Mycoplasma pneumonia
+- Urinary tract infections
+- Sexually transmitted diseases: Infections due to Chlamydia trachomatis including uncom-plicated urethral, endocervical or rectal infections, non gonococcal urethritis, chancroid, granuloma inguinale, lymphogranuloma venereum, gonorrhoea, syphilis
... Read more
Oxytetracycline is indicated in-
+
+- Respiratory tract infections
+- Mycoplasma pneumonia
+- Urinary tract infections
+- Sexually transmitted diseases: Infections due to Chlamydia trachomatis including uncom-plicated urethral, endocervical or rectal infections, non gonococcal urethritis, chancroid, granuloma inguinale, lymphogranuloma venereum, gonorrhoea, syphilis
+- Skin infections: Acne and rosacea
+- Ophthalmic infections: Trachoma
+- Rickettsial infections
+- Other infections: Psittacosis, brucellosis, cholera, acute
+- intestinal amoebiasis etc.
+
","Eye Anti-Infectives & Antiseptics, Tetracycline group of drugs, Topical antibiotics for Acne
","Oxytetracycline inhibits cell growth by inhibiting translation. It binds to the 30S ribosomal subunit and prevents the amino-acyl tRNA from binding to the A site of the ribosome. The binding is reversible in nature. Oxytetracycline is lipophilic and can easily pass through the cell membrane or passively diffuses through porin channels in the bacterial membrane.
","Adults: 250-500 mg every 6 hours. Food, milk and some dairy products interfere with the absorption of Tetracyclines. So Tetracyclines should be given one hour before or two hours after meals.
",,"Antacids containing Aluminium, Calcium, Magnesium, Zinc or Iron salts may impair the absorption of Oxytetracycline. In long term therapy, Tetracyclines depress plasma prothrombin activity and reduced doses of concomitant anticoagulants may be necessary. A few cases of pregnancy or breakthrough bleeding have been attributed to the concurrent use of Tetracyclines or Oxytetracyclines with oral contraceptives.
","Oxytetracycline should not be used with patients who are hypersensitive to Tetracyclines. It should not be used in children under 12 years of age. It is contraindicated in pregnant women because of tooth staining in the fetus and possible growth retardation effects.
","Side effects of Oxytetracycline, which have been reported in some patients, are anorexia, nausea, vomiting, diarrhoea, glossitis, skin rashes and urticaria.
","Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues and can have toxic effects on the developing fetus. Evidence of embryotoxicity has also been noted in animals treated early in pregnancy. Tetracyclines are present in the milk of lactating women who are taking a drug in this class.
","Oxytetracycline should be used with caution in renal impairment.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+849,Oxyphenonium Bromide,oxyphenonium-bromide-849,,Anticholinergics (antimuscarinics)/ Anti-spasmodics,Visceral spasms,"Oxyphenonium is indicated in Gastro-intestinal spasm and hypermotility, cardiospasm, esophagospasm, gastroduodenitis, spastic constipation, pylorospasm, peptic ulcer, spasm associated with carcinoma. Pain and spasm of the biliary tract. Pain and spasm of the urinary tract.
","Anticholinergics (antimuscarinics)/ Anti-spasmodics
","Oxyphenonium is an anticholinergic drug, a medication that reduces the effect of acetylcholine, a chemical released from nerves that stimulates muscles, by blocking the receptors for acetylcholine on smooth muscle (a type of muscle). It also has a direct relaxing effect on smooth muscle. Oxyphenonium is used to treat or prevent spasm in the muscles of the gastrointestinal tract in the irritable bowel syndrome. In addition, Oxyphenonium inhibits gastrointestinal propulsive motility and decreases gastric acid secretion and controls excessive pharyngeal, tracheal and bronchial secretions.
","Average adult dosage is 10 mg (2 tablets) 4 times daily for several days. Dosage may be reduced depending on patient's response or as directed by the physician.
",,"Reduced gastric motility interferes with absorption of other drugs. Effects potentiated by other antimuscarinics including amantadine, some antihistamines, phenothiazines and TCA.
","Glaucoma, obstructive uropathy (for example, bladder neck obstruction due to prospective hypertrophy), obstructive disease of the gastrointestinal tract (as in achalasia, paralytic ileus, pyloroduodenal stenosis, etc.), intestinal atony of the elderly or debilitated patient, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon, complicating ulcerative colitis, myasthenia gravis, hypersensitivity.
","Common side effects are dryness of mouth, headache, palpitations, etc.
","Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Children; elderly; benign prostatic hyperplasia; acute MI, cardiac failure, hypertension, thyrotoxicosis; pregnancy and lactation; fever; angle-closure glaucoma.
",,"Treatment is the same as for atropine overdosage.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+848,Oxyphencyclimine Hydrochloride,oxyphencyclimine-hydrochloride-848,,Anticholinergics (antimuscarinics)/ Anti-spasmodics,Spasm,"Oxyphencyclimine is indicated for the treatment of peptic ulcer disease and the relief of smooth muscle spasms in gastrointestinal disorders.
","Anticholinergics (antimuscarinics)/ Anti-spasmodics
","Oxyphencyclimine binds the muscarinic acetylcholine receptor. It may block all three types of muscarinic receptors including M-1 receptors in the CNS and ganglia, M-2 receptors in the heart (vagus) and M-3 receptors at the parasympathetic NEJ system. The muscarinic acetylcholine receptors mediate various cellular responses, including inhibition of adenylate cyclase, breakdown of phosphoinositides and modulation of potassium channels through the action of G proteins. Oxphencyclimine inhibits vagally mediated reflexes by antagonizing the action of acetylcholine. This in turn reduces the secretion of gastric acids in the stomach.
","Adult: 10 mg twice daily orally.
",,"Enhanced effect with concurrent admin of other drugs with antimuscarinic properties and MAOIs. May affect absorption of other drugs. Antagonistic effect with parasympathomimetics.
","Closed-angle glaucoma; obstructive uropathy; GI obstruction, paralytic ileus, intestinal atony, ulcerative colitis; toxic megacolon; myasthenia gravis.
","Xerostomia, decreased sweating, urinary hesitancy and retention, blurred vision, cycloplegia, increased ocular tension, loss of taste, headache, nervousness, mental confusion, impotence, suppression of lactation, urticaria, constipation.
","Pregnancy category- Not classified
","Elderly; autonomic neuropathy; hepatic or renal disease; hyperthyroidism, CHF, thyrotoxicosis, MI, tachyarrhythmias, hypertension, prostatic hypertrophy; hiatal hernia. May impair ability to drive or operate machinery. Pregnancy and lactation. Down's syndrome.
",,"Symptoms range from increased side effects to CNS disturbances, circulatory changes, respiratory failure, paralysis and coma. treat with immediate gastric lavage and injection of physostimine 0.5-2 mg up to a total of 5 mg. Treat symptomatically and supportively.
",,,,10
+847,Oxymorphone Hydrochloride,oxymorphone-hydrochloride-847,https://medex.com.bd/attachments/UkXzBaMIJZPHLfAQ2AXtMmg86wB6V4/oxymorphone-hydrochloride-extended-release-tablets-prescribing-information,Opioid analgesics,Pain,"Tablet is indicated for treatment of moderate to severe pain like chronic cancer, arthritis, postoperative & low back pain.
Injection is indicated for the relief of moderate to severe pain. It is also indicated for pre-operative & post-operative medication for support of anesthesia ... Read more
Tablet is indicated for treatment of moderate to severe pain like chronic cancer, arthritis, postoperative & low back pain.
Injection is indicated for the relief of moderate to severe pain. It is also indicated for pre-operative & post-operative medication for support of anesthesia, for obstetrical analgesia and for relief of anxiety in patients with dyspnea associated with pulmonary edema secondary to acute left ventricular dysfunction.
","Opioid analgesics
","Oxymorphone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxymorphone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with oxymorphone. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression.
The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.
","Oxymorphone Tablet: This may be used as needed in the treatment of acute post-surgical pain with a dose of 5-10 mg every 4 hours. Administer Oxymorphone Tablet on an empty stomach at least one hour prior to or two hours after eating.
Oxymorphone Injection:
+
+- Subcutaneous or Intramuscular Administration: Initially 1 mg to 1.5 mg, repeated every 4 to 6 hours as needed.
+- Intravenous: 0.5 mg initially. For analgesia during labor 0.5 mg to 1 mg intramuscularly is recommended.
+
+
Conversion from Oral Oxymorphone to Oxymorphone Injection: Given the absolute oral bioavailability of approximately 10%, patients receiving oral Oxymorphone may be converted to Oxymorphone Hydrochloride injection by administering one-tenth the patient's total daily oral Oxymorphone dose as Oxymorphone Hydrochloride injectable in four or six equally divided doses (e.g., total daily oral dose/ [10X4]). For example, approximately 1 mg of Oxymorphone Hydrochloride injectable IM every 6 hours (4 mg total IM dose) may be required to provide pain relief equivalent to a total daily dose of 40 mg oral Oxymorphone. As with any opioid drug product, it is necessary to adjust the dosing regimen for each patient individually taking into account the patient's prior analgesic treatment experience.
",,"Clinical drug interaction studies with Oxymorphone showed no induction of CYP450 3A4 or 2C9 enzyme activity indicating that no dose adjustment for CYP 3A4 or 2C9 mediated drug-drug interactions is required.
","
+- Significant respiratory depression
+- Acute or severe bronchial asthma or hypercarbia
+- Known or suspected paralytic ileus
+- Moderate and severe hepatic impairment
+- Hypersensitivity (e.g. anaphylaxis) to oxymorphone
+
","General Disorders: Respiratory depression, Fatigue, Asthenia.
Metabolism and Nutrition Disorders: Anorexia.
Cardiac Disorders: Tachycardia, Bradycardia, Palpitations.
Eye Disorders: Miosis, Diplopia, Blurred vision.
Gastrointestinal Disorders: Vomiting, Constipation.
Psychiatric Disorders: Dysphoria, Euphoric mood, Nervousness, Restlessness, Insomnia, Agitation, Hallucination, Depression.
Vascular Disorders: Hypotension & Flushing.
","Pregnancy Category C. The safety of using Oxymorphone in pregnancy has not been established with regard to possible adverse effects on fetal development. The use of Oxymorphone in pregnancy, in nursing mothers, or in women of child-bearing potential requires that the possible benefits of the drug be weighed against the possible hazards to the mother and the child.
","Do not stop abruptly; taper gradually to stop treatment. Use caution in patients with acute pancreatitis, Addison disease, benign prostatic hyperplasia, cardiac arrhythmias, central nervous system (CNS) depression, drug abuse or dependence, emotional lability, gallbladder disease, gastrointestinal (Gl) disorder, pseudomembranous colitis, Gl surgery, head injury, hypothyroidism or untreated myxedema, intracranial hypertension, brain tumor, toxic psychosis, urethral stricture, urinary tract surgery, seizures, acute alcoholism, delirium tremens, shock, cor pulmonale, chronic pulmonary disease, emphysema, kyphoscoliosis, severe obesity, renal or hepatic impairment, elderly or debilitated patients.
Avoid alcohol. Reduce dosage if drug is coadministered with other CNS depressants. Thrombocytopenia purpura resulting in kidney failure or death has been reported when extended-release tablets are dissolved and injected IV. May obscure diagnosis of abdominal conditions.
Risk of opioid addiction, abuse, and misuse, which can lead to overdose and death Assess each patient's risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions Life-threatening respiratory depression, life-threatening, or fatal respiratory depression may occur
Monitor for respiratory depression, especially during initiation or following a dose increase
","Pediatric use: Safety and effectiveness of Oxymorphone Hydrochloride tablet and injection in pediatric patients below the age of 18 years have not been established.
Geriatric use: Oxymorphone Hydrochloride tablet and injection should be used with caution in elderly patients. These adverse events included dizziness, somnolence, confusion and nausea.
","Signs and Symptoms: Acute overdosage with Oxymorphone is characterized by respiratory depression, extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils and sometimes bradycardia and hypotension.
Treatment: In the treatment of Oxymorphone overdosage, primary attention should be given to the re-establishment of a patient airway and institution of assisted or controlled ventilation. Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. The opioid antagonist naloxone hydrochloride is a specific antidote against respiratory depression that may result from overdosage or unusual sensitivity to opioids including Oxymorphone
",,,"Tablet: Store in a cool and dry place, protect from light.
Injection: Store at 25°C, protect from light.
",12
+846,Oxymetazoline Hydrochloride (Nasal Preparation),oxymetazoline-hydrochloride-nasal-preparation-846,https://medex.com.bd/attachments/CniixT7wnjbJJFOw6VDK2gSHCqizJL/oxymetazoline-hydrochloride-nasal-preparation-prescribing-information,Nasal Anti-histamine preparations,Sinusitis,"Oxymetazoline Hydrochlorid is indicated for the treatment of nasal congestion associated with acute or chronic rhinitis, common cold, sinusitis, upper respiratory allergies, epistaxis and hay fever. It is also used as nasal decongestant in otitis media.
","Nasal Anti-histamine preparations, Nasal Decongestants & Other Nasal Preparations
","Oxymetazoline Hydrochloride is an imidazoline derivative sympathomimetic amine. It is a direct agonist at α-adrenoceptors but has no action on β- adrenoceptors. It is used as a topical agent on the nasal mucosa, produces a rapid and long acting vasoconstriction of the arterioles, thus reducing the blood flow and diminishing swelling of the mucosa. This results in improved potency of the airway and better drainage of the nasal sinus.
","Oxymetazoline nasal spray-
+
+- Adults and children (6 years of age and older): 2 or 3 sprays in each nostril twice daily for 3-5 days.
+- Elderly: There is no need for dosage reduction in the elderly for nasal administration.
+- Children below 6 years of age: It is not suitable for children below 6 years of age.
+
+Oxymetazoline nasal drop-
+
+- Adults & children 6 years of age: 2-3 drops of 0.05% Nasal Drops in each nostril twice daily in the morning and evening.
+- Children 2-5 years of age: 2-3 drops of 0.025% Nasal Drops in each nostril twice daily in the morning and evening
+
","How to use the Nasal Spray-
+
+- Shake the bottle gently and remove the dust cover.
+- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
+- Gently blow the nose to clear the nostrils.
+- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
+- Breathe out through your mouth.
+- Repeat the above steps in the same/ other nostril for consecutive doses.
+
+Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-
+
+- Remove the dust cover.
+- Gently pull off the nasal applicator.
+- Wash the applicator and dust cover in warm water.
+- Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
+- Gently push the applicator back on the top of the bottle and re-fix the dust cover.
+
","Oxymetazoline Hydrochloride Nasal preparation should not be given to patients being treated with MAO inhibitors or within 14 days of ceasing such treatment.
","It is contraindicated in patients with cardiovascular disease, hyperthyroidism, prostatic enlargement, angle closure glaucoma and hypersensitivity to any of its ingredients.
","Occasionally it may cause local irritation and dryness of the mouth and throat. Temporarily discomfort such as burning, stinging, sneezing or increase in nasal discharge may occur.
","The safety of Oxymetazoline Hydrochloride Nasal Spray during pregnancy and lactation has not been established, but is not thought to constitute a hazard during those periods.
","Keep away from the eyes. The spray should not be used for longer than seven days without medical advice. Frequent or prolonged use may cause nasal congestion to recur or worsen.
",,"Overdose may give rise to local irritation and rebound congestion. Treatment need only be symptomatic.
",,,"Keep below 30° C temperature in a dry place, protect from light. Do not refrigerate or freeze. Keep out of the reach of children.
",12
+1444,Oxymetazoline Hydrochloride (Cream),oxymetazoline-hydrochloride-cream-1444,https://medex.com.bd/attachments/WGV6UNViSSoAs8JqCOKiVH2CTnHfM0/oxymetazoline-hydrochloride-cream-prescribing-information,Vasoconstrictor/Venotonic,Rosacea,"Oxymetazoline Hydrochloride cream is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.
","Vasoconstrictor/Venotonic
","Oxymetazoline is an alpha1A adrenoceptor agonist. Oxymetazoline acts as a vasoconstrictor.
","For topical use only, it is not for oral, ophthalmic or intravaginal use. Apply a little amount of the cream, once daily in a thin layer to cover the entire face (forehead, nose, each cheek and chin) avoiding eyes and lips. Wash hands immediately after applying the cream.
",,,,"Most common side effects are application site dermatitis, worsening inflammatory lesions of rosacea, application site pruritis, application site erythema and application site pain.
","The safety of oxymetazoline during pregnancy and lactation has not been established, but use during this period is not considered to constitute a hazard.
","Alpha-adrenergic agonists may impact blood pressure. Advise patients with ardiovascular disese, orthostatic hypotension and/or uncontolled hypertension or hypotension to seek medical care if their condition worsens. Use with caution in patients with cerebral or coronary insufficiency, Raynaud’s phenomenon, thromboangiitis obliterans, scleroderma or Sjögren’s syndrome and advisepatients to seek medical care if signs and symptoms of potentiation of vascular insufficiency develop. Advise patients to seek immediate medical care if signs and symptoms of acute narrow-angle glaucoma develop.
",,"Oxymetazoline is not for oral use. If oral ingestion occurs, seek medical advice. Monitor patient closely and administer appropriate supportive measures as necessary
",,,"Do not store above 30° C. Keep away from light and out of the reach of children.
",9
+845,Oxybutynin Chloride,oxybutynin-chloride-845,https://medex.com.bd/attachments/8mobAHuZtlFsbuChG0CjICyIxPTeIE/oxybutynin-chloride-prescribing-information,Anticholinergics (antimuscarinics)/ Anti-spasmodics,Urinary frequency and urgency,"Oxybutynin Chloride is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin Chloride Extended Release Tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).
","Anticholinergics (antimuscarinics)/ Anti-spasmodics
","Oxybutynin exerts direct antispasmodic effect on the smooth muscle by inhibiting the muscarinic action of acetylcholine. It exhibits moderate anticholinergic effect, but has potent antispasmodic effects on urinary smooth muscle.
","The recommended starting dose of Uricon is 5 mg once daily, with or without food. Dosage may be adjusted in 5 mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 30 mg/day). In general, dosage adjustment may proceed at approximately weekly intervals.
","May be taken with or without food.
","Anticholinergic agents, cytochrome P450 enzyme inhibitors, such as antimycotic agents (e.g., Ketoconazole, Itraconazole, and Miconazole) or macrolide antibiotics (e.g., erythromycin and clarithromycin), have not been performed. No specific drug-drug interaction studies have been performed with Oxybutynin.
","Oxybutynin Chloride is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow angle glaucoma and in patients who are at risk for these conditions. It is also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.
","The incidence of dry mouth may occur which is dose-related. Abdominal pain, dry nasal and sinus mucous membranes, back pain, hypertension, palpitation, vasodilatation, flatulence, gastro-esophageal reflux, insomnia, nervousness, confusion, cough, sinusitis, bronchitis, dry skin, rash, impaired urination (hesitancy), urinary retention, etc. may be reported.
","Oxybutynin Chloride should not be given to pregnant women unless, the probable clinical benefits outweigh the possible hazards, caution should be exercised when it is administered to a nursing woman.
","Oxybutynin Chloride should be used with caution in patients with hepatic or renal impairment, clinically significant bladder outflow obstruction because of the risk of urinary retention, gastrointestinal obstructive disorders because of the risk of gastric retention, conditions such as ulcerative colitis, intestinal atony, and myasthenia gravis, gastro-esophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis.
",,"Anticholinergic effects including CNS excitation (e.g. restlessness, tremor, irritability, convulsions, delirium, hallucinations), flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention may occur after overdose. Treatment should be symptomatic and supportive. Activated charcoal may be administered.
",,,"Store at 15-30° C
",12
+844,Oxybuprocaine Hydrochloride,oxybuprocaine-hydrochloride-844,https://medex.com.bd/attachments/1iHRVtMpBMVoIHEMxDDDQYARD25E1q/oxybuprocaine-hydrochloride-prescribing-information,Ocular perioperative drugs,Local anaesthesia,"Used to temporarily numb the front surface of the eye so that the eye pressure can be measured or a foreign body removed.
","Ocular perioperative drugs
","Oxybuprocaine is a local anaesthetic. It may be less irritating than tetracaine, and the onset and duration of action are similar to tetracaine. Oxybuprocaine binds to sodium channel and reversibly stabilizes the neuronal membrane which decreases its permeability to sodium ions. Depolarization of the neuronal membrane is inhibited thereby blocking the initiation and conduction of nerve impulses.
","Use as a 0.4% solution in short ophthalmic procedures. Instil 1 drop into the conjunctival sac to allow tonometry after 60 sec; a further drop after a 90 sec interval produces sufficiReduce systemic absorption by compressing the lacrimal sac at the medial canthus for a minute during and following instillation. Heart block; epilepsy, impaired cardiac conduction, myasthenia gravis; not to be applied to inflamed, infected tissues or damaged mucosa. Protect anaesthetised eye from dust and bacterial contamination; cornea may be damaged by prolonged application. Do not drive until normal vision restored.ent anaesthesia for the fitting of contact lenses; 3 drops at 90 sec intervals produces sufficient anaesthesia after 5 min for a foreign body to be removed from the corneal epithelium or for incision of a meibomian cyst through the conjunctiva.
",,,,"Hypersensitivity reactions; transient stinging and blurring of vision; excitation of CNS; muscle twitching and tremors; convulsions.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Reduce systemic absorption by compressing the lacrimal sac at the medial canthus for a minute during and following instillation. Heart block; epilepsy, impaired cardiac conduction, myasthenia gravis; not to be applied to inflamed, infected tissues or damaged mucosa. Protect anaesthetised eye from dust and bacterial contamination; cornea may be damaged by prolonged application. Do not drive until normal vision restored.
",,,,,,7
+843,Oxiconazole Nitrate,oxiconazole-nitrate-843,https://medex.com.bd/attachments/VqhsqtdbgA4E2Hi7vi0o38s6vrzDoe/oxiconazole-nitrate-prescribing-information,Topical Antifungal preparations,Tinea corporis (ringworm),"Oxiconazole topical preparation is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. Oxiconazole Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur.
","Topical Antifungal preparations
","This topical preparation contains the antifungal active compound Oxiconazole Nitrate. For topical dermatological use only. Oxiconazole Nitrate is an imidazole derivative whose antifungal activity is derived primarily from the inhibition of ergosterol biosynthesis, which is critical for cellular membrane integrity. It has in vitro activity against a wide range of pathogenic fungi. Oxiconazole has been shown to be active against most strains of the following organisms both in vitro and in clinical infections at indicated body sites: Epidermophyton floccosum, Trichophyton mentagrophytes, Trichophyton rubrum, Malassezia furfur. Oxiconazole exhibits satisfactory in vitro minimum inhibitory concentrations (MICs) against most strains of the following organisms: Microsporum audouini, Microsporum canis, Microsporum gypseum, Trichophyton tonsurans,Trichophyton violaceum.
","This topical preparation should be applied to affected and immediately surrounding areas once to twice daily in patients with tinea pedis, tinea corporis, or tinea cruris. Oxiconazole Cream should be applied once daily in the treatment of tinea (pityriasis) versicolor. Tinea corporis, tinea cruris, and tinea (pityriasis) versicolor should be treated for 2 weeks and tinea pedis for 1 month to reduce the possibility of recurrence.
","
+- Use Oxiconazole topical preparation as directed by the physician. The hands should be washed after applying the medication to the affected area(s). Avoid contact with the eyes, nose, mouth, and other mucous membranes. Oxiconazole cream isfor external use only.
+- Use the medication for the full treatment time recommended by the physician, even though symptoms may have improved. Notify the physician if there is no improvement after 2 to 4 weeks orsooner if the condition worsens.
+- Inform the physician if the area of application shows signs of increased irritation, itching, burning, blistering, swelling, or oozing.
+- Avoid the use of occlusive dressings unless otherwise directed by the physician.
+- Do not use this medication for any disorder other than that for which it was prescribed
+
","Potential drug interactions between Oxiconazole and other drugs have not been systematically evaluated.
","Oxiconazole topical preparation is contraindicated in individuals who have shown previous hypersensitivity to Oxiconazole
","Pruritus, burning, irritation and allergic contact dermatitis, folliculitis, erythema, and papules, fissure, maceration, rash, stinging and nodules.
","Pregnancy category B. Because Oxiconazole Nitrate is excreted in human milk, caution should be exercised when the drug is administered to a nursing woman.
","Oxiconazole topical preparation is not for ophthalmic or intravaginal use.
",,,,,"Store in a cool and dry place,protected from light. Do not freeze.
",11
+842,Oxcarbazepine,oxcarbazepine-842,https://medex.com.bd/attachments/eJj7HUEwh2TaJwUwkHWCXfVGAfKREY/oxcarbazepine-prescribing-information,Adjunct anti-epileptic drugs,Trigeminal neuralgia,"Oxcarbazepine is indicated for:
Adults: Monotherapy or adjunctive therapy in the treatment of partial seizures
Pediatrics:
+
+- Monotherapy in the treatment of partial seizures in children 4-16 years
+- Adjunctive therapy in the treatment of partial seizures in children 2–16 years
+
","Adjunct anti-epileptic drugs
","The pharmacological activity of Oxcarbazepine is primarily exerted through the metabolite derivative (the monohydroxy derivative, MHD) of Oxcarbazepine. The mechanism of action of Oxcarbazepine and MHD is thought to be mainly based on blockade of voltage-sensitive sodium channels, thus resulting in stabilization of hyper excited neural membranes, inhibition of repetitive neuronal firing and diminishment of propagation of synaptic impulses.
","Adults: initiate with a dose of 600 mg/day, given twice-a-day
+
+- Adjunctive Therapy: Maximum increment of 600 mg/day at approximately weekly intervals. The recommended daily dose is 1200 mg/day
+- Conversion to Monotherapy: withdrawal concomitant over 3 to 6 weeks;reach maximum dose of Oxcarbazepine in 2 to 4 weeks with increments of 600 mg/day at weekly intervals to a recommended daily dose of 2400 mg/day
+- Initiation of Monotherapy: Increments of 300 mg/day every third day to a dose of 1200 mg/day.
+- Creatinine Clearance <30 mL/min: Initiate at one half the usual starting dose and increase slowly
+
+
Pediatrics: initiation with 8 to 10 mg/kg/day, given twice-a-day. For patients aged 2 to <4 years and under 20 kg, a starting dose of 16 to 20 mg/kg/day may be considered. Recommended daily dose is dependent upon patient weight.
+
+- Adjunctive Patients (Aged 2–16 Years): For patients aged 4 to 16 years, target maintenance dose should be achieved over 2 weeks. For patients aged 2 to <4 years, maximum maintenance dose should be achieved over 2 to 4 weeks and should not to exceed 60 mg/kg/day
+- Conversion to Monotherapy for Patients (Aged 4-16 Years): Maximum increment of 10 mg/kg/day at weekly intervals, concomitant antiepileptic drugs can be completely withdrawn over 3 to 6 weeks
+- Initiation of Monotherapy for Patients (Aged 4–16 Years): Increments of 5 mg/kg/day every third day
+
",,"Oxcarbazepine and its metabolite inhibit the enzyme CYP2C19 and therefore, interactions could arise when co-administering high doses of Oxazep with medicinal products that are metabolised by CYP2C19 (e.g. phenobarbital, phenytoin). Concurrent use of Oxazep with hormonal contraceptives may render few contraceptives ineffective (e.g. Ethinylestradiol and Levonorgestrel preparations). Co-administration of Oxazep lowers AUC of felodipine and Verapamil decreases bioavailability of MHD.
","It is contraindicated to patients with hypersensitivity to the active substance or to any of the excipients.
","The most commonly reported adverse reactions are somnolence, headache, dizziness, diplopia, nausea; vomiting and fatigue. Very rarely clinically significant hyponatraemia can develop during Oxazep use. Class I (immediate) hypersensitivity reactions including rash, pruritus, urticaria, angioedema and reports of anaphylaxis have been received.
","Pregnancy: Data on a limited number of pregnancies indicate that Oxcarbazepine may cause serious birth defects (e.g. cleft palate) when administered during pregnancy. In the newborn child. Bleeding disorders in the newborn caused by antiepileptic agents have been reported. As a precaution, vitamin K1 should be administered as a preventive measure in the last few weeks of pregnancy and to the newborn. Oxcarbazepine and its active metabolite (MHD) cross the placenta. Neonatal and maternal plasma MHD concentrations were similar in one case.
Lactation: Oxcarbazepine and its active metabolite (MHD) are excreted in human breast milk. Therefore, Oxazep should not be used during breast-feeding.
","Alcohol: Caution should be exercised if alcohol is taken in combination with Oxazep therapy, due to a possible additive sedative effect.
Withdrawal: As with all antiepileptic medicinal products, Oxazep should be withdrawn gradually to minimise the potential of increased seizure frequency.
",,,,,,9
+1860,Oxazepam,oxazepam-1860,https://medex.com.bd/attachments/DTYbUIHi0HBkseLKtmAASbg0lEqpX5/oxazepam-prescribing-information,Tricyclic Anti-depressant,Anxiety,"Oxazepam is used in the treatment of anxiety disorders, including anxiety associated with depression. This drug seems to be particularly effective for anxiety, tension, agitation and irritability in older people. It is also prescribed to relieve symptoms of acute alcohol withdrawal.
","Tricyclic Anti-depressant
","Oxazepam belongs to a class of drugs called ""Benzodiazepine"" which act on the brain and nerves (central nervous system) to produce a calming effect. It works by enhancing the effect of a natural chemical in the brain (GABA).
","Adult:
+
+- Mild to Moderate Anxiety with Tension, Irritability and Agitation: The usual dose is 10 to 15 milligrams 3 or 4 times per day.
+- Severe Anxiety, Depression with Anxiety, or Alcohol Withdrawal: The usual dose is 15 to 30 milligrams, 3 or 4 times per day.
+
+
Children:
+
+- Safety and effectiveness have not been established for children less than 6 years of age,
+- Nor have dosage guidelines been established for children 6 to 12 years. The doctor will adjust the dosage to fit the child's needs.
+
+
Older adults: The usual starting dose is 10 milligrams, 3 times a day. The doctor may increase the dose to 15 milligrams 3 or 4 times a day if needed.
",,"Oxazepam may intensify the effects of alcohol. It may be best to avoid alcohol while taking this medication. If Oxazepam is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with a doctor before combining Oxazepam with the following: Antihistamines such as Diphenhydramine Narcotic painkillers such as Oxycodone and Pethidine Sedatives such as Secobarbital and Triazolam Tranquilizers such as Diazepam and Alprazolam.
","The drug is contraindicated in individuals who have an allergic reaction to Oxazepam or other benzodiazepines such as diazepam. Oxazepam should not be prescribed if any patient is being treated for mental disorders which are more serious than anxiety.
","Side effects cannot be anticipated. If any develop or change in intensity, doctor should be informed immediately. Doctor will determine if it is safe for a patient to continue taking Oxazepam. More common side effect includes drowsiness. Less common or rare side effects include: Blood disorders, change in libido, dizziness, excitement, fainting, headache, liver problems, loss or lack of muscle control, nausea, skin rashes or eruptions, sluggishness or unresponsiveness, slurred speech, swelling due to fluid retention, tremors, vertigo, yellowed eyes and skin. Side effects due to rapid decrease or abrupt withdrawal from Oxazepam: Abdominal and muscle cramps, convulsions, depressed mood, inability to fall or stay asleep, sweating, tremors, vomiting.
","This medication is not recommended for use during pregnancy due to the potential possible fetal harm. Based on information from related drugs, this drug may pass into breast milk and may have undesirable effects on a nursing infant. Therefore, breastfeeding while using this medication is not recommended.
","This drug may make dizzy, drowsy or cause blurred vision; caution should be taken while engaging in activities requiring alertness such as driving or using machinery. The limit should be maintained while taking alcoholic beverages. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the drowsiness effect.
",,,,,"Store in a cool and dry place, protected from light and moisture. Keep out of reach of children.
",10
+833,Oxaprozin,oxaprozin-833,https://medex.com.bd/attachments/zKkpxn3W1xfXwyi131WCWjOBO3fXMU/oxaprozin-prescribing-information,Drugs for Osteoarthritis,Rheumatoid arthritis,"Oxaprozin is indicated:
+
+- For relief of the signs and symptoms of osteoarthritis
+- For relief of the signs and symptoms of rheumatoid arthritis
+- For relief of the signs and symptoms of juvenile rheumatoid arthritis
+
","Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Oxaprozin, the potassium salt of oxaprozin, is a nonsteroidal anti-inflammatory drug (NSAID), which dissociates into the active moiety oxaprozin in vivo. Oxaprozin has analgesic, anti-inflammatory, and antipyretic properties.
The mechanism of action of Oxaprozin, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).
Oxaprozin is a potent inhibitor of prostaglandin synthesis in vitro. Oxaprozin concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because oxaprozin potassium is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.
","General Dosing Instructions: Carefully consider the potential benefits and risks of Oxaprozin and other treatment options before deciding to use Oxaprozin. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. After observing the response to initial therapy with Oxaprozin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Divided doses may be tried in patients unable to tolerate single doses. For osteoarthritis patients of low body weight or with milder disease, an initial dose of one 600 mg tablet once a day may be appropriate. The maximum total daily dose is 1200 mg.
Osteoarthritis: For Osteoarthritis, the dosage is 1200 mg (two 600 mg tablets) given orally once a day.
Rheumatoid Arthritis: For Rheumatoid Arthritis, the dosage is 1200 mg (two 600 mg tablets) given orally once a day.
",,"Increased risk of salicylate toxicity with aspirin. May increase effects of oral anticoagulants. May reduce effects of β-blockers, diuretics and other antihypertensive agents. May increase risk of methotrexate and lithium toxicity.
","Previous or active peptic ulceration, known hypersensitivity to NSAIDs. Perioperative pain in CABG setting.
","Common side effects are depression, sedation, somnolence, confusion, disturbance of sleep, weakness, malaise; rash, prutitus, urticaria, photosensitivity; abdominal pain/distress, anorexia, flatulence, vomiting, constipation, diarrhoea, dyspepsia, nausea, peptic ulcer and/or GI bleeding, abnormalities in LFTs, stomatitis, haemorrhoidal or rectal bleeding; tinnitus; dysuria or frequency; oedema, BP changes; haematuria, renal insufficiency, decreased menstrual flow; anaemia, thrombocytopenia, leukopenia, ecchymoses; wt gain/loss; blurred vision, conjunctivitis.
The following adverse reactions may occur:
+
+- Cardiovascular Thrombotic Events
+- GI Bleeding, Ulceration and Perforation
+- Hepatotoxicity
+- Hypertension
+- Heart Failure and Edema
+- Renal Toxicity and Hyperkalemia
+- Anaphylactic Reactions
+- Serious Skin Reactions
+- Hematologic Toxicity
+
","Pregnancy categaory: C, D (in 3rd trimester or near delivery)
","Be alert for ulceration and bleeding in patients treated chronically. History of serious GI events, alcoholism, smoking, other factors known to be associated with peptic ulcer. Elderly or debilitated patients. Uncompensated cardiac failure, history of hypertension, cardiac decompensation, chronic diuretic therapy, conditions predisposing to fluid retention. Renal and hepatic impairment. Underlying coagulation defects or patients who are undergoing surgical procedures where a high degree of haemostasis is required. Pregnancy (avoid in 3rd trimester) and lactation.
","Renal Impairment-
Osteoarthritis: Severe or on dialysis: 600 mg once daily. Increase to 1.2 g daily if needed.
Rheumatoid arthritis: Severe or on dialysis: 600 mg once daily. Increase to 1.2 g daily if needed.
","Symptoms: Acute renal failure, vomiting, drowsiness, leukocytosis.
Management: Supportive and symptomatic. Multiple admin of charcoal may be required to reduce potential for delayed toxicities.
",,,"Store at 25° C. Protect from light.
",12
+832,Oxaliplatin,oxaliplatin-832,https://medex.com.bd/attachments/K8ZhzdENZSQUpoSUiSfXKxoj0bSKxY/oxaliplatin-prescribing-information,Cytotoxic Chemotherapy,Oesophageal cancer,"Oxaliplatin, used in combination with infusional 5-fluorouracil/leucovorin, is indicated for:
+
+- Adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor.
+- Treatment of advanced colorectal cancer.
+
","Cytotoxic Chemotherapy
","Oxaliplatin, a platinum-containing complex similar to cisplatin, is an alkylating agent. After intracellular hydrolysis, the platinum compound binds to DNA forming cross-links which inhibit DNA replication and transcription, resulting in cell death.
","Intravenous (Adult)-
Adjuvant therapy in stage III colon cancer: In combination with fluorouracil/ leucovorin: 85 mg/m2 every 2 wk for 12 cycles. Dose to be given by IV infusion over 2-6 hr, dissolved in 250-500 ml of glucose 5%, every 2 wk; given for 12 cycles. After recovery from toxicity, reduce dose to 75 mg/m2. Administer before fluoropyrimidines.
Advanced colorectal cancer: In combination with fluorouracil/ leucovorin: 85 mg/m2 every 2 wk until disease progression or unacceptable toxicity. Dose to be given by IV infusion over 2-6 hr, dissolved in 250-500 ml of glucose 5%, . After recovery from toxicity, reduce dose to 65 mg/m2. Administer before fluoropyrimidines.
",,"May decrease plasma levels of digoxin. May increase risk of toxicity with nephrotoxic drugs. When administered as sequential infusions, taxane derivatives (docetaxel, paclitaxel) should be administered before oxaliplatin to limit myelosuppression and enhance efficacy.
","Pregnancy. Peripheral neuropathy with functional impairment. Severe renal impairment.
","Fatigue, fever, pain, headache, insomnia, nausea, diarrheoa, vomiting, abdominal pain, constipation, anorexia, stomatitis, anemia, thrombocytopenia, leukopenia, aspartate and alanine transaminases increased, total bilirubin increased, peripheral neuropathy, back pain, dyspnoea, cough, oedema, chest pain, peripheral oedema, flushing , thromboembolism, dizziness, rash, alopecia , hand-foot syndrome dehydration, hypokalaemia, dyspepsia, taste perversion, flatulence, mucositis, gastroesophageal reflux, dysphagia, dysuria, neutropenia, inj site reaction, rigors, arthralgia, abnormal lacrimation, serum creatinine increased, rhinitis, epistaxis, pharyngitis, pharyngolaryngeal dysesthesia, allergic reactions, hiccup.
","Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Should be administered under the supervision of an experienced cancer chemotherapy physician. Use appropriate precautions for handling and disposal. Monitor neurological status and dose should be reduced if symptoms are prolonged or severe. Monitor blood counts during treatment and courses should not be repeated until blood counts have recovered. Caution in elderly, moderate degrees of renal impairment. Avoid using aluminum-containing needles or IV admin sets that may come into contact with oxaliplatin as aluminum has been reported to cause degradation of platinum compounds. Lactation.
","Renal Impairment: Dose adjustment may be needed
","Extensions of known adverse reaction (e.g. thrombocytopenia, myelosuppression, nausea, vomiting, neurotoxicity, respiratory symptoms). Treatment is supportive.
",,"Reconstitute with 10 ml (for 50 mg vial) or 20 ml (for 100 mg vial) water for inj or 5% dextrose inj. Reconstituted solution must be further diluted with 250-500 ml of 5% dextrose inj before admin.
","Store intact vials at 15-30°C; do not freeze. Reconstituted solution: May store at 2-8°C for up to 24 hr. Diluted solutions: Stable up to 6 hr at 20-25°C or up to 24 hr under refrigeration at 2-8°C.
",13
+1859,Ospemifene,ospemifene-1859,https://medex.com.bd/attachments/ldS7SxIFjYaMebtU8uwW7hdKHg3Ntm/ospemifene-prescribing-information,Drugs used in Vaginal and Vulval condition,Vaginal dryness,"Ospemifene is indicated for:
+
+- The Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, Due to Menopause.
+- The Treatment of Moderate to Severe Vaginal Dryness, a Symptom of Vulvar and Vaginal Atrophy, Due to Menopause.
+
","Drugs used in Vaginal and Vulval condition
","Ospemifene is an estrogen receptor agonist/antagonist with tissue selective effects. Its biological actions are mediated through binding to estrogen receptors. This binding results in activation of estrogenic pathways in some tissues (agonism) and blockade of estrogenic pathways in others (antagonism).
","Ospemifene is an estrogen agonist/antagonist which has agonistic effects on the endometrium. Use of Ospemifene should be for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.
+
+- Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, Due to Menopause: Take one 60 mg tablet with food once daily.
+- Treatment of Moderate to Severe Vaginal Dryness, a Symptom of Vulvar and Vaginal Atrophy, Due to Menopause: Take one 60 mg tablet with food once daily.
+
",,"
+- Do not use estrogens or estrogen agonist/antagonist concomitantly with Ospemifene.
+- Do not use fluconazole concomitantly with Ospemifene. Fluconazole increases serum concentrations of Ospemifene.
+- Do not use rifampin concomitantly with Ospemifene. Rifampin decreases serum concentration of Ospemifene.
+
","Ospemifene is contraindicated in women with any of the following conditions:
+
+- Undiagnosed abnormal genital bleeding
+- Known or suspected estrogen-dependent neoplasia
+- Active DVT, pulmonary embolism (PE), or a history of these conditions
+- Active arterial thromboembolic disease [for example, stroke and myocardial infarction (MI)], or a history of these conditions
+- Hypersensitivity (for example, angioedema, urticaria, rash, pruritus) to Ospemifene or any ingredients
+- Ospemifene is contraindicated in women who are or may become pregnant. Ospemifene may cause fetal harm when administered to a pregnant woman. Ospemifene was embryo-fetal lethal with labor difficulties and increased pup deaths in rats at doses below clinical exposures, and embryo-fetal lethal in rabbits at 10 times the clinical exposure based on mg/m 2 . If this drug is used during pregnancy, or if a woman becomes pregnant while taking this drug, she should be apprised of the potential hazard to a fetus.
+
","Adverse reactions (≥1 percent) include hot flush, vaginal discharge, muscle spasms, headache, hyperhidrosis, vaginal hemorrhage, night sweats.
","Pregnancy: Ospemifene is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if a woman becomes pregnant while taking this drug, she should be apprised of the potential hazard to a fetus. Based on animal data, Ospemifene is likely to increase the risk of adverse outcomes during pregnancy and labor. Adverse findings at maternally toxic doses included embryofetal lethality in rats and rabbits, and neonatal mortality and difficult labor in rats. The reproductive effects observed are consistent with and are considered to be related to the estrogen receptor activity of Ospemifene.
Lactation: It is not known whether Ospemifene is excreted in human breast milk. There are no data on the effects of Ospemifene on the breastfed child or the effects on milk production. Do not breastfeed while taking Ospemifene. Ospemifene was excreted in rat milk
","
+- Venous Thromboembolism: Risk of DVT and pulmonary embolism
+- Known, suspected, or history of breast cancer
+- Severe Hepatic Impairment
+
","Pediatric Use: Ospemifene is not indicated in children. Clinical studies have not been conducted in the pediatric population.
Geriatric Use: Of the 2209 Ospemifene-treated women enrolled in the ten phase 2/3 trials of Ospemifene, >19 percent were 65 years of age or older. No clinically meaningful differences in safety or effectiveness were observed between these women and younger women less than 65 years of age.
Renal Impairment: The pharmacokinetics of ospemifene in women with severe renal impairment (CrCL <30 mL/min) was similar to those in women with normal renal function. No dose adjustment of Ospemifene is required in women with renal impairment.
Hepatic Impairment: The pharmacokinetics of ospemifene has not been studied in women with severe hepatic impairment (Child-Pugh Class C); therefore, do not use Ospemifene in women with severe hepatic impairment
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+1296,Osimertinib,osimertinib-1296,https://medex.com.bd/attachments/4h8mGYy2cQW4Pe9T6PLhEnU4yDIh9f/osimertinib-prescribing-information,Cytotoxic Chemotherapy,Non-small cell lung cancer,"Osimertinib is indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
","Cytotoxic Chemotherapy
","Osimertinib is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that binds to certain mutant forms of EGFR (T790M, L858R, and exon 19 deletion) that predominate in non-small cell lung cancer (NSCLC) tumours following treatment with first-line EGFR-TKIs. As a third-generation tyrosine kinase inhibitor, osimertinib is specific for the gate-keeper T790M mutation which increases ATP binding activity to EGFR and results in poor prognosis for late-stage disease. Furthermore, osimertinib has been shown to spare wild-type EGFR during therapy, thereby reducing non-specific binding and limiting toxicity.
","The recommended dose of Osimertinib is 80 mg once a day until disease progression or unacceptable toxicity. Osimertinib can be taken with or without food. If a dose of Osimertinib is missed, do not make up the missed dose and take the next dose as scheduled.
","Administration To Patients Who Have Difficulty Swallowing Solids: Disperse tablet in 60 ml (2 ounces) of non-carbonated water only. Stir until tablet is dispersed into small pieces (the tablet will not completely dissolve) and swallow immediately. Do not crush, heat, or ultrasonicate during preparation. Rinse the container with 120 ml to 240 ml (4 to 8 ounces of) water and immediately drink.
If administration via nasogastric tube is required, disperse the tablet as above in 15 ml of non-carbonated water, and then use an additional 15 ml of water to transfer any residues to the syringe. The resulting 30 ml liquid should be administered as per the nasogastric tube instructions with appropriate water flushes (approximately 30 ml).
","Strong CYP3A4 Inducers: If concurrent use is unavoidable, increase Osimertinib dosage to 160 mg daily when coadministering with a strong CYP3A inducer. Resume Osimertinib at 80 mg 3 weeks after discontinuation of the strong CYP3A4 inducer
",,"Common side effects are Interstitial Lung Disease or Pneumonitis, QTc Interval Prolongation, Cardiomyopathy, Keratitis
","Use in Pregnancy: There are no or limited amount of data from the use of Osimertinib in pregnant women. Studies in animals have shown reproductive toxicity. Based on its mechanism of action and preclinical data, Osimertinib may cause foetal harm when administered to a pregnant woman. Administration of osimertinib to pregnant rats was associated with embryolethality, reduced foetal growth and neonatal death at exposures similar to what is expected in humans. Osimertinib is not recommended during pregnancy and in women of childbearing potential not using contraception.
Use in Lactation: It is not known whether osimertinib or its metabolites are excreted in human milk. Administration to rats during gestation and early lactation was associated with adverse effects, including reduced growth rates and neonatal death. There is insufficient information on the excretion of osimertinib or its metabolites in animal milk. A risk to the suckling child cannot be excluded. Breast-feeding should discontinue during treatment with Osimertinib.
Fertility: There are no data on the effect of Osimertinib on human fertility. Results from animal studies have shown that Osimertinib has effects on male and female reproductive organs and could impair fertility
",,,,,,"Store Osimertinib at room temperature between 20°C to 25°C. Safely throw away medicine that is out of date or that you no longer need. Keep Osimertinib and all medicines out of the reach of children.
",9
+831,Oseltamivir,oseltamivir-831,https://medex.com.bd/attachments/3E4JX0kQqKev3UpTkXtP6JOME8m2iL/oseltamivir-prescribing-information,Respiratory viral infections (Influenza),Swine flu,"Oseltamivir is indicated for prevention of flu (influenza) in adults and adolescents aged 13 years and over who have been in contact with someone diagnosed with flu; treatment of flu (influenza) in adults and in children over one year of age when the influenza virus is circulating in the community
","Respiratory viral infections (Influenza)
","Oseltamivir is a prodrug of oseltamivir carboxylate. Oseltamivir carboxylate inhibits neuraminidase (sialidase), a viral surface enzyme which is responsible for the replication and infectivity of influenza virus A and B, thereby preventing the release of viruses from infected cells.
","Oseltamivir Phosphate may be taken with or without food. However, when taken with food, tolerability may be enhanced in some patients.
Standard oral dose for the treatment of influenza:
+
+- Adults and Adolescents: The recommended oral dose of Oseltamivir for treatment of influenza in adults and adolescents 13 years and older is 75 mg twice daily for 5 days. Treatment should begin within 2 days of onset of symptoms of influenza.
+- Pediatric patients: The safety and efficacy of Oseltamivir for prophylaxis of influenza in pediatric patients younger than 13 years of age have not been established.
+
+Recommended oral dose for the treatment of influenza:
+
+- For prophylaxis of influenza in adults and adolescents 13 years and older following close contact with an infected individual: 75 mg once daily for at least 7 days. Therapy should begin within 2 days of exposure.
+- For prophylaxis during a community outbreak of influenza: 75 mg once daily. Safety and efficacy have been demonstrated for up to 6 weeks. The duration of protection lasts for as long as dosing is continued.
+
","May be taken with or without food. May be taken with meals to reduce GI discomfort. Cap may be opened & mixed with sweetened food products eg chocolate syr, sweetened condensed milk, apple sauce or yogurt. Swallow mixture immediately after preparation.
","Information derived from pharmacology and pharmacokinetic studies of Oseltamivir suggests that clinically significant drug interactions are unlikely. Co-administration with amoxicillin does not alter plasma levels of either compound.
","Oseltamivir is contraindicated in patients with known hypersensitivity to any of the components of the product.
","The most frequently reported adverse events are nausea and vomiting. These events generally of mild to moderate degree and usually are occurred on the first 2 days of administration. Additional adverse events occurring in <1% of patients receiving Oseltamivir for treatment include unstable angina, anemia, pseudomembranous colitis, humerus fracture, pneumonia, pyrexia, and peritonsillar abscess.
","Pregnancy Category C: There are insufficient human data upon which to base an evaluation of risk of Oseltamivir Phosphate to the pregnant woman or developing fetus.
Nursing Mothers: It is not known whether oseltamivir or oseltamivir carboxylate is excreted in human milk. Oseltamivir Phosphate should, therefore, be used only if the potential benefit for the lactating mother justifies the potential risk to the breast-fed infant.
","There is no evidence for efficacy of Oseltamivir Phosphate in any illness caused by agents other than influenza viruses Types A and B. Efficacy of Oseltamivir Phosphate in patients who begin treatment after 40 hours of symptoms has not been established.
","Hepatic Impairment: The safety and pharmacokinetics in patients with hepatic impairment have not been evaluated.
Renal Impairment: Dose adjustment is recommended for patients with a serum creatinine clearance <30 mL/min.
Geriatric Use: The safety of Oseltamivir Phosphate has been established in clinical studies.
Pediatric Use: The safety and efficacy of Oseltamivir Phosphate in pediatric patients younger than 1 year of age have not been studied. Oseltamivir Phosphate is not indicated for either treatment or prophylaxis of influenza in pediatric patients younger than 1 year of age.
","At present there has been no experience of over dose. Single dose of up to 1000 mg of Oseltamivir have been associated with nausea and/or vomiting.
",,,"Store at 25°C. Reconstituted susp: Store between 2-8°C for up to 17 days or at 25°C for up to 10 days. Do not freeze.
",13
+830,Ornidazole,ornidazole-830,https://medex.com.bd/attachments/xaJ9DrSlfYukbJFBi7pWyOP8VmhKkK/ornidazole-prescribing-information,Amoebicides,Trichomoniasis,"Ornidazole is indicated for Amoebiasis (Intestinal and hepatic), Giardiasis, Trichomoniasis, Bacterial vaginosis, Treatment of susceptible anaerobic infections
","Amoebicides, Anti-diarrhoeal Antiprotozoal
","Ornidazole is a 5-nitroimidazole derivative active against protozoa and anaerobic bacteria. It is converted to reduction products that interact with DNA to cause destruction of helical DNA structure and strand leading to a protein synthesis inhibition and cell death in susceptible organisms.
","Amoebiasis:
+
+- Adults: 500 mg twice a day for 5 days.
+- Children: 10-25 mg per kg body weight in two divided doses.
+
+Amoebic dysentery:
+
+- Adults: 1.5 gm once a day for 3 days.
+- Children: 40 mg per kg body weight, once a day for 3 days.
+
+Giardiasis:
+
+- Adults: 1.5 gm once daily for 1-2 days.
+- Children: 40 mg per kg body weight for 2 days.
+
+
Trichomoniasis: 1.5 gm once or 500 mg twice a day for 5 days. Sexual partner should also be treated at the same time.
Bacterial vaginosis: 3 tablets of 500 mg each as a single dose or one tablet of 500 mg once daily for 5-7 days.
",,"Like other imidazoles, Ornidazole has a mild potential to cause disulfiramlike reactions. Concomitant administration of oral anticoagulants may increase the risk of haemorrhage due to diminished hepatic metabolism. Ornidazole has been reported to decrease the clearance of 5-fluorouracil.
","Previous hypersensitivity to Ornidazole and to other nitroimidazoles. Ornidazole is contraindicated in central nervous system disorders, particularly in epilepsy or in peripheral neuropathy.
","Side effects of Ornidazole have been mainly limited to the gastrointestinal tract (nausea, vomiting, epigastric pain) and central nervous system (dizziness, headache, lassitude). Unlike other nitroimidazoles, Ornidazole does not interact with alcohol, although this requires further study.
Leukopenia has been described occasionally during therapy. Adverse central nervous system (CNS) effects of Ornidazole have mainly included headache, dizziness, lassitude or somnolence, fatigue and weakness. Adverse CNS effects of Ornidazole may be less than that happens with metronidazole. Seizures have not been reported with Ornidazole in studies available to date.
","Adequate clinical trials have not been conducted. Ornidazole should be prescribed only if the potential benefit justifies the potential risk to fetus/neonate.
","In patient with ataxia, vertigo, and mental confusion, Ornidazole should be prescribed with caution. During prolonged treatment with Ornidazole, blood dyscrasia namely mild leukopenia have been reported rarely. In case leukopenia occurs, the decision to discontinue the therapy should depend upon the gravity of infection.
","Renal Impairment Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.
Hepatic Impairment Severe: Double the interval between doses.
",,,,"Store at room temperature and protect from light and moisture.
",11
+829,Orlistat,orlistat-829,https://medex.com.bd/attachments/0nG8IUm0J0obHVIm062S4VF9T0EBiD/orlistat-prescribing-information,Appetite suppressant drugs/Anti-obesity drugs,Obesity,"Adults: Orlistat is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI)>30 kg/m2 and overweight patients (BMI >28 kg/m2 ) with associated risk factors such as type II diabetes, hyperlipidemia ... Read more
Adults: Orlistat is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI)>30 kg/m2 and overweight patients (BMI >28 kg/m2 ) with associated risk factors such as type II diabetes, hyperlipidemia and hypertension. Treatment with Orlistat should be discontinued after 12 weeks in patients who have not lost at least 5% of their body weight as measured at the start of drug therapy.
Adolescents (12 years & older): Obese adolescents should be treated with Orlistat only if an adequate reduction of body weight cannot be achieved by means of diet & increased physical activity. Treatment with orlistat should be considered in particular if complications of obesity are present.
","Appetite suppressant drugs/Anti-obesity drugs
","Orlistat is a potent, specific and long-acting lipase inhibitor. It exerts its therapeutic activity in the lumen of the stomach and upper small intestine by forming a covalent bond with the active serine site of gastric and pancreatic lipases. The inactivated enzyme is thus rendered unable to hydrolyze dietary fats in the form of triglycerides into absorbable free fatty acids and monoglycerides. As undigested triglycerides can not be absorbed, a caloric deficit arises which has a positive effect on weight control. Systemic absorption of orlistat is therefore not needed for the activity. At the recommended therapeutic dose of 120 mg three times a day, orlistat inhibit dietary fat absorption by approximately 30%.
","The recommended dose of Orlistat is one 120 mg capsule to be taken immediately before, during or up to one hour after each main meal. If a meal is missed or contains no fat the dose of Orlistat should be omitted. Doses of Orlistat above 120 mg three times daily have not been shown to provide additional benefits. The effect of Orlistat results in an increase in fecal fat 24-48 hours after dosing. Upon discontinuation of therapy, fecal fat content usually returns to pretreatment levels within 48-72 hours.
The safety & efficacy of Orlistat were investigated in clinical studies lasting up to 4 years. The recommended dose of Orlistat for adolescents is as same as adults.
Special dosage instruction: The tolerability and efficacy of Orlistat have not been studied in elderly patients, or patients with hepatic and/ or renal impairments.
",,"No interactions with commonly prescribed medications such as alcohol, digoxin, nifedipine, oral contraceptives, phenytoin, pravastatin, warfarin, or metformin, glibenclamide, fibrates, furosemide, captopril, or atenolol have been observed in studies.
","Orlistat is contraindicated in patients with chronic malabsorption syndrome, in patients with cholestasis and in patients who are hypersensitive to orlistat or to any of the other ingredients of the capsules.
","Common: Undesirable effects of Orlistat are largely gastrointestinal in nature. Common gastrointestinal side effects are oily spotting from the rectum, flatulence, fecal urgency, oily or fatty stool, abdominal discomfort etc.
Rare: Influenza, anxiety. headache, fatigue etc may rarely occur in some patients. Rare cases of hypersensitivity have been reported. Main clinical symptoms are pruritus, exanthema, urticaria, angioedema and anaphylaxis.
","Use in pregnancy & lactation: No clinical data are available on pregnancy exposed to Orlistat. As it is not known whether Orlistat is excreted in breast milk. Orlistat should not be used during breastfeeding.
","Organic causes of obesity (e.g. hypothyroidism) should be excluded before prescribing Orlistat. Orlistat and cyclosporine should not be coadministered. Cyclosporine should be taken at least 2 hours before or after Orlistat in patients taking both drugs. Cyclosporine level should be measured and frequently monitored.
In clinical trial, the decrease in body weight with Orlistat therapy was less in type II diabetic patients than in non-diabetic patients. Antidiabetic drug treatment should be closely monitored during Orlistat therapy. Because of the improvement in glycemic control, the dose of oral antidiabetics or of insulin may need to be adjusted.
Patients should be advised to adhere to the dietary recommendations. The probability of occurrence of gastrointestinal side effects may increase when Orlistat is taken with a fatty meal. The daily intake of fat should be distributed between three main meals. Patients should be strongly encouraged to take a multivitamin supplement that contains fat soluble vitamins to ensure adequate nutrition because orlistat has been shown to reduce the absorption of some fat soluble vitamins & beta-carotene. In addition, the levels of vitamin D & beta carotene may be low in obese patients compared with non-obese patients.
",,"Single doses of 800 mg Orlistat and multiple doses of up to 400 mg three times a day for 15 days have been studied in normal weight and obese subjects without significant adverse findings.
",,,"Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.
",11
+915,Oral Rehydration Salt [Rice Based],oral-rehydration-salt-rice-based-915,,Oral electrolytes preparations,Severe diarrhea,"This saline is indicated in-
+
+- Acute fluid and electrolyte loss conditions such as cholera, acute diarrhea & vomiting
+- Dehydration
+- Severely low concentrations of salts in the blood (severe electrolyte depletion)
+
","Oral electrolytes preparations
","This saline contains essential electrolytes & carbohydrate (in the form of processed rice) which are vital for a dehydrating patient in conditions such as cholera, acute diarrhoea, vomiting & excessive sweating.
In the normal healthy intestine, there is a continuous exchange of water through the intestinal wall- up to 20 liters of water is secreted and very nearly as much is reabsorbed every 24 hours- this mechanism allows the absorption of soluble metabolites from digested food into the bloodstream.
In a state of diarrheal disease, the balance is upset and much more water is secreted than is reabsorbed causing a net loss to the body which can be as high as several liters a day. In addition to water, Chloride ion (CI
-), extracellular sodium ion (Na
+) & intracellular potassium ion (K
+) are also lost. This saline is effectively replenishes the lost electrolytes in the body.
The pharmacokinetics and therapeutic values of the substances of this saline are as follows:
+
+- Glucose (comes from rice) facilitates the absorption of sodium (and hence water) on a 1:1 molar basis in the small intestine
+- Sodium and potassium are needed to replace the body losses of these essential ions during diarrhoea and vomiting
+- Citrate corrects the acidosis that occurs as a result of diarrhoea and dehydration
+
+Rice, a carbohydrate is converted to glucose through digestion. Glucose is then absorbed through intestinal wall with salt. Addition of rice (instead of pure glucose) to this formula reduces the osmolarity of the solution,thus preventing additional loss of fluid through stools.
","The dose depends on the severity of the dehydrating conditions of the patients. Recommended dose after each watery stool are as follows:
+
+- 6 months to 2 years: 50 ml to 100 ml (10 to 20 Teaspoonfuls)
+- 2 years to 9 years: 100 ml to 200 ml (20 to 40 teaspoonfuls)
+- 10 years and above: 250 ml to 500 ml (1 to 2 glassfuls)
+
","
+- Discard any unused reconstituted saline after 5 hours of preparation
+- After preparing the saline further heating or boiling is not necessary
+- Feeding-bottle should not be used
+- Mix the solution with a clean spoon each time before administration
+- Syringe without needle may be used to put a small amount of saline into babies' mouth
+
","There is no known drug interaction reported.
","
+- Kidney failure resulting in diminished production of urine (oliguria)
+- Kidney failure, preventing the production of urine (anuria)
+- Obstruction of the stomach or intestines
+- Reduced blood flow to vital internal organs (shock)
+- Severe and continuous vomiting (intractable vomiting)
+- Severe dehydration
+- Severe diarrhea in infants.
+
",,"Recommended in pregnancy & lactation, as there is no known harmful effects when this medicine is used.
","Precautions should be taken in case of significant overdose, especially for the following patients-
+
+- Children less than 1 year of age.
+- Patients with imbalance of salt concentrations in the blood (electrolyte imbalance).
+- Patients with severely decreased kidney and liver function.
+
",,,,"Preparation for 250 ml Saline: Wash both hands with soap before preparing the saline. Add 250 ml (one glassful) hot boiled water into a jar. Then add full sachet of this saline (for 250 ml water) powder into the jar. Mix the powder well in the water until a milky white solution appears. Give the solution to the patient to drink as per the dose.
Preparation for 500 ml Saline: Wash both hands with soap before preparing the saline. Add 500 ml hot boiled water (two glassfuls) into a jar. Then add full sachet of this saline (for 500 ml water) powder into the jar. Mix the powder well in the water until a milky white solution appears. Give the solution to the patient to drink as per the dose.
","Store in a cool & dry place, protected from light & moisture.
",11
+866,Pefloxacin Mesylate Dihydrate,pefloxacin-mesylate-dihydrate-866,,4-Quinolone preparations,,"Pefloxacin is indicated in adult for the treatment of single infection or mixed infections caused by two or more susceptible microorganisms. It can also be used for infections caused by organisms resistant to other antibiotics. Pefloxacin is indicated to the following manifestations:
+
+- Gastrointestinal infection ... Read more
Pefloxacin is indicated in adult for the treatment of single infection or mixed infections caused by two or more susceptible microorganisms. It can also be used for infections caused by organisms resistant to other antibiotics. Pefloxacin is indicated to the following manifestations:
+
+- Gastrointestinal infection: Enteric fever, acute bacterial diarrhoea & chronic Salmonella carriers.
+- Urinary tract infection: Cystitis, pyelonephritis, prostatitis, epididymitis, uncomplicated and complicated urethritis.
+- Respiratory tract infection: Pneumonia, acute and chronic bronchitis, cystic fibrosis, bronchiectasis, empyema.
+- Ear, nose and throat infection: Otitis media, otitis externa, sinusitis, tonsillitis.
+- Bone and joint infection: Osteomyelitis, arthritis.
+- Skin and soft tissue infection: Infected ulcer, wound infection, abscess, cellulitis, erysipelas and infected burn.
+- Pelvic infection: Salpingitis, endometritis, pelviperitonitis.
+- Abdominal and hepatobiliary infection: Peritonitis, intra abdominal abscess and cholingitis, cholecystitis and empyema of the gall bladder.
+- Also used in septicemia, bacteraemia, gonorrhoea, endocarditis, meningitis.
+
","4-Quinolone preparations
","Pefloxcin is a synthetic antibacterial agent, belongs to fluoroquinolone group. It exerts its action by inhibiting the subunit-A of DNA gyrase (Topoisomerase II). Pefloxcin is bactericidal and has a broad spectrum of activity.
","Adult with normal hepatic function: Pefloxcin 400 mg tablet 12 hourly (morning & evening) with meals to avoid gastrointestinal disturbances. An initial loading dose of 800 mg may be given in order to produce effective blood concentration more rapidly.
Adult with hepatic insufficiency: In patients with severe hepatic insufficiency or reduced blood supply to the liver, the daily doses should be readjusted by increasing the intervals between doses. Dosage need not to be reduced in renal insufficiency.
Duration of Treatment:
+
+- Usually 5 to 10 days.
+- For chronic prostatitis, cystic fibrosis & chronic Salmonella carriers: 14 days.
+- For endocarditis: Up to 6 months.
+- For chronic osteomyelitis: Up to 1 year.
+- For gonorrhoea: 2 tablets single dose.
+
",,"When taken concomitantly with an Antacid containing Aluminium and/or Magnesium Hydroxide gel, absorption of Pefloxacin is reduced. So, concurrent administration of these agents with Pefloxacin should be avoided.
","Pefloxacin is contraindicated in patients with known hypersensitivity to Quinolone, children under 15 years of age, pregnant and lactating mothers, patient with inborn glucose-6-phosphate dehydrogenase deficiency and patients with history of tendon lesion, tendonitis or tendon rupture.
","Occasionally observed reactions are - Gastrointestinal disturbance: Epigastric pain, nausea, vomiting, diarrhoea, dyspepsia. Central nervous system disturbance: Headache, insomnia. Hypersensitivity reaction: Skin rash, pruritis, photosensitization. Others: Myalgia and/or arthralgia, tendonitis, rupture of achilles tendon.
","Pefloxacin has been assigned to pregnancy category C by the FDA.
","Because of the risk of photosensitivity reaction, exposure to sunlight and ultraviolet radiation should be avoided during Pefloxacin therapy. Dosage readjustment is required in severe hepatic insufficiency. Patients should be informed of the possibility of pain in the achilles tendon.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+865,Pazopanib Hydrochloride,pazopanib-hydrochloride-865,https://medex.com.bd/attachments/aIN9NMBH6wxK5zzxjCC9Y71idMd7DE/pazopanib-hydrochloride-prescribing-information,,,"Pazopanib is indicated for the treatment of patients with advanced renal cell carcinoma (RCC). Pazopanib is indicated for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. The efficacy of Pazopanib for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors has not been demonstrated.
",,"Pazopanib is a multi-tyrosine kinase inhibitor of vascular endothelial growth factor receptor (VEGFR)-1, VEGFR 2, VEGFR-3, platelet-derived growth factor receptor (PDGFR)-α and -β, fibroblast growth factor receptor (FGFR)-1 and -3, cytokine receptor (Kit), interleukin-2 receptor-inducible T-cell kinase (Itk), lymphocyte-specific protein tyrosine kinase (Lck), and transmembrane glycoprotein receptor tyrosine kinase (c-Fms). In vitro, Pazopanib inhibited ligand-induced autophosphorylation of VEGFR-2, Kit, and PDGFR-β receptors.
Absorption: Pazopanib is absorbed orally with median time to achieve peak concentrations of 2 to 4 hours after the dose. Daily dosing at 800 mg results in geometric mean AUC and C max of 1,037 mcg/mL and 58.1 mcg/mL (equivalent to 132 µM), respectively. There was no consistent increase in AUC or C max at Pazopanib doses above 800 mg.
Distribution: Binding of Pazopanib to human plasma protein in vivo was greater than 99% with no concentration dependence over the range of 10 to 100 mcg/mL. In vitro, studies suggest that Pazopanib is a substrate for P-gp and BCRP.
Metabolism: In vitro studies demonstrated that Pazopanib is metabolized by CYP3A4 with a minor contribution from CYP1A2 and CYP2C8.
Elimination: Pazopanib has a mean half-life of 30.9 hours after administration of the recommended dose of 800 mg. Elimination is primarily via feces with renal elimination accounting for less than 4% of the administered dose.
","The recommended starting dose of Pazopanib is 800 mg orally once daily without food (at least 1 hour before or 2 hours after a meal). The dose of Pazopanib should not exceed 800 mg. Tablets should not be crushed due to the potential for increased rate of absorption which may affect systemic exposure. If a dose is missed, it should not be taken if it is less than 12 hours until the next dose. Or, as directed by the registered physicians.
",,"Drugs that Inhibit or Induce Cytochrome P450 3A4 Enzymes: In vitro studies suggested that the oxidative metabolism of Pazopanib in human liver microsomes is mediated primarily by CYP3A4, with minor contributions from CYP1A2 and CYP2C8. Therefore, inhibitors and inducers of CYP3A4 may alter the metabolism of Pazopanib.
CYP3A4 Inhibitors: Coadministration of Pazopanib with strong inhibitors of CYP3A4 (e.g., Ketoconazole, Ritonavir, Clarithromycin) increases Pazopanib concentrations and should be avoided. Consider an alternate concomitant medication with no or minimal potential to inhibit CYP3A4. If coadministration of a strong CYP3A4 inhibitor is warranted, reduce the dose of Pazopanib to 400 mg. Grapefruit or grapefruit juice should be avoided as it inhibits CYP3A4 activity and may also increase plasma concentrations of Pazopanib.
CYP3A4 Inducers: CYP3A4 inducers, such as Rifampin, may decrease plasma Pazopanib concentrations. Consider an alternate concomitant medication with no or minimal enzyme induction potential. Pazopanib should not be used if chronic use of strong CYP3A4 inducers cannot be avoided.
Drugs that Inhibit Transporters: In vitro studies suggested that Pazopanib is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP). Therefore, absorption and subsequent elimination of Pazopanib may be influenced by products that affect P-gp and BCRP. Concomitant treatment with strong inhibitors of P-gp or BCRP should be avoided due to risk of increased exposure to Pazopanib. Selection of alternative concomitant medicinal products with no or minimal potential to inhibit P-gp or BCRP should be considered.
Effects of Pazopanib on CYP Substrates: Results from drug-drug interaction trials conducted in cancer patients suggest that Pazopanib is a weak inhibitor of CYP3A4, CYP2C8, and CYP2D6 in vivo, but had no effect on CYP1A2, CYP2C9, or CYP2C19. Concomitant use of Pazopanib with agents with narrow therapeutic windows that are metabolized by CYP3A4, CYP2D6, or CYP2C8 is not recommended. Coadministration may result in inhibition of the metabolism of these products and create the potential for serious adverse events.
Effect of Concomitant Use of Pazopanib and Simvastatin: Concomitant use of Pazopanib and Simvastatin increases the incidence of ALT elevations. Across monotherapy trials with Pazopanib, ALT greater than 3 x ULN was reported in 126/895 (14%) of patients who did not use statins, compared with 11/41 (27%) of patients who had concomitant use of Simvastatin. If a patient receiving concomitant Simvastatin develops ALT elevations, follow dosing guidelines for Pazopanib or consider alternatives to Pazopanib. Alternatively, consider discontinuing Simvastatin. Insufficient data are available to assess the risk of concomitant administration of alternative statins and Pazopanib.
","It is contraindicated in patients with known hypersensitivity to Pazopanib or any other components of this product.
","Common side effects of Pazopanib include:
+
+- Hepatic Toxicity and Hepatic Impairment
+- QT Prolongation and Torsades de Pointes
+- Cardiac Dysfunction
+- Hemorrhagic Events
+- Arterial and Venous Thromboembolic Events
+- Thrombotic Microangiopathy
+- Gastrointestinal Perforation and Fistula
+- Interstitial Lung Disease/Pneumonitis
+- Reversible Posterior Leukoencephalopathy Syndrome
+- Hypertension
+- Hypothyroidism
+- Proteinuria
+- Tumor Lysis Syndrome
+- Infection
+- Increased Toxicity with Other Cancer Therapy
+
","Pazopanib can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform a drug-associated risk. Pregnant women or women should be advised of the childbearing potential of the potential risk to a fetus. There is no information regarding the presence of Pazopanib or its metabolites in human milk, or their effects on the breastfed infant, or on milk production. Because of the potential for serious adverse reactions in breastfed infants from Pazopanib, a lactating woman should be advised not to breastfeed during treatment with Pazopanib and for 2 weeks after the final dose.
","Hepatic Toxicity and Hepatic Impairment: In clinical trials with Pazopanib, hepatotoxicity, manifested as increases in serum transaminases (alanine transferase [ALT], aspartate aminotransferase [AST]) and bilirubin, was observed. This hepatotoxicity can be severe and fatal. Patients older than 65 years are at greater risk for hepatotoxicity. Transaminase elevations occur early in the course of treatment (92.5% of all transaminase elevations of any grade occurred in the first 18 weeks).
QT Prolongation and Torsades De Pointes: In the RCC trials of Pazopanib, QT prolongation (greater than or equal to 500 msec) was identified on routine electrocardiogram (ECG) monitoring in 2% (11/558) of patients. Torsades de pointes occurred in less than 1% (2/977) of patients who received Pazopanib in the monotherapy trials. Pazopanib should be used with caution in patients with a history of QT interval prolongation, in patients taking antiarrhythmics or other medications that may prolong QT interval, and those with relevant pre-existing cardiac disease. When using Pazopanib, baseline and periodic monitoring of ECGs and maintenance of electrolytes (e.g., calcium, magnesium, potassium) within the normal range should be performed.
","Females: Pazopanib can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should be advised to use effective contraception during treatment and for at least 2 weeks after the last dose of Pazopanib.
Males: To avoid potential drug exposure to pregnant partners and female partners of reproductive potential, male patients (including those who have had vasectomies) with female partners of reproductive potential should be advised to use condoms during treatment with Pazopanib and for at least 2 weeks after the last dose.
Pediatric Use: The safety and effectiveness of Pazopanib in pediatric patients have not been established.
","Pazopanib doses up to 2000 mg have been evaluated in clinical trials. Dose-limiting toxicity (Grade 3 fatigue) and Grade 3 hypertension were each observed in 1 of 3 patients dosed at 2000 mg daily and 1000 mg daily, respectively. Treatment of overdose with Pazopanib should consist of general supportive measures. There is no specific antidote for overdosage of Pazopanib. Hemodialysis is not expected to enhance the elimination of Pazopanib because Pazopanib is not significantly renally excreted and is highly bound to plasma proteins.
",,,"Store below 30° C in a cool and dry place, away from sunlight. Keep out of reach of children.
",11
+864,Paroxetine Hydrochloride,paroxetine-hydrochloride-864,https://medex.com.bd/attachments/BmWJ3NbCvuVx0lXx2JIH7U6IFovqUq/paroxetine-hydrochloride-prescribing-information,SSRIs & related anti-depressant drugs,Social anxiety disorder,"Paroxetine is indicated in:
+
+- Major Depressive Disorder
+- Obsessive Compulsive Disorder
+- Panic Disorder
+- Social Anxiety Disorder
+- Generalized Anxiety Disorder
+- Posttraumatic Stress Disorder.
+
","SSRIs & related anti-depressant drugs
","The efficacy of Paroxetine is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin (5-hydroxy-tryptamine, 5 HT). Studies at clinically relevant doses in humans have demonstrated that paroxetine blocks the uptake of serotonin into human platelets. In vitro studies in animals also suggest that paroxetine is a potent and highly selective inhibitor of neuronal serotonin reuptake and has only very weak effects on norepinephrine and dopamine neuronal reuptake. In vitro radioligand binding studies indicate that paroxetine has little affinity for muscarinic, alpha1, alpha2, beta adrenergic, dopamine (D2), 5-HT1, 5 HT2 and histamine (H1)-receptors; antagonism of muscarinic, histaminergic and alpha1-adrenergic receptors has been associated with various anticholinergic, sedative and cardiovascular effects for other psychotropic drugs. Because the relative potencies of paroxetine’s major metabolites are at most 1/50 of the parent compound, they are essentially inactive.
","Major Depressive Disorder:
+
+- Usual Initial Dosage: Paroxetine (Paroxetine hydrochloride) should be administered as a single daily dose with or without food, usually in the morning. The recommended initial dose is 20 mg/day. Some patients not responding to a 20 mg dose may benefit from dose increases, in 10 mg/day increments, up to a maximum of 50 mg/day. Dose changes should occur at intervals of at least 1 week.
+- Maintenance Therapy: Systematic evaluation of the efficacy of Paroxetine hydrochloride has shown that efficacy is maintained for periods of up to 1 year with doses that averaged about 30 mg.
+
+Obsessive Compulsive Disorder (OCD):
+
+- Usual Initial Dosage: Paroxetine (Paroxetine hydrochloride) should be administered as a single daily dose with or without food, usually in the morning. The recommended dose of Paroxetine in the treatment of OCD is 40 mg daily. Patients should be started on 20 mg/day and the dose can be increased in 10 mg/day increments. Dose changes should occur at intervals of at least 1 week.
+- Maintenance Therapy: Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.
+
+Panic Disorder:
+
+- Usual Initial Dosage: Paroxetine should be administered as a single daily dose with or without food, usually in the morning. The target dose of Paroxetine in the treatment of panic disorder is 40 mg/day. Patients should be started on 10 mg/day. Dose changes should occur in 10 mg/day increments and at intervals of at least 1 week. The maximum dosage should not exceed 60 mg/day.
+- Maintenance Therapy: Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.
+
+Social Anxiety Disorder (SAD):
+
+- Usual Initial Dosage: Paroxetine should be administered as a single daily dose with or without food, usually in the morning. The recommended initial dosage is 20 mg/day.
+- Maintenance Therapy: Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.
+
+Generalized Anxiety Disorder (GAD):
+
+- Usual Initial Dosage: Paroxetine should be administered as a single daily dose with or without food, usually in the morning. The recommended starting dosage and the established effective dosage is 20 mg/day.
+- Maintenance Therapy: Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.
+
+Posttraumatic Stress Disorder (PTSD):
+
+- Usual Initial Dosage: Paroxetine should be administered as a single daily dose with or without food, usually in the morning. The recommended starting dosage and the established effective dosage is 20 mg/day. Dose changes, if indicated, should occur in 10 mg/day increments and at intervals of at least 1 week.
+- Maintenance Therapy: Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.
+
",,"Food/antacids: The absorption and pharmacokinetics of Paroxetine are not affected by food or antacids.
Tryptophan: As with other 5-HT re uptake inhibitors, animal studies indicate that an interaction between Paroxetine and Tryptophan may occur, resulting in a ‘serotonin syndrome’ suggested by a combination of agitation, restlessness and gastrointestinal symptoms including diarrhoea.
Drug metabolizing enzyme inducers /inhibitors: The metabolism and pharmacokinetics of Paroxetine may be affected by drugs, which induce or inhibit hepatic drug metabolizing enzymes. When Paroxetine is to be coadministered with a known drug metabolizing inhibitor, consideration should be given to using doses at the lower end of the range. No initial dosage adjustment of Paroxetine is considered necessary when it is to be co-administered with known drug metabolizing enzyme inducers. Any subsequent dosage adjustment should be guided by clinical effect (tolerabilityand efficacy).
Alcohol: Although Paroxetine does not increase the impairment of mental and motor skill caused by alcohol, the concomitant use of Paroxetine and alcohol in depressed patients is not advised.
Haloperidol/amylobarbitone/oxazepam: Experience in a limited number of healthy subjects has shown that Paroxetine did not increase the sedation and drowsiness associated with haloperidol, amylobarbitone or oxazepam when given in combination.
MAOls: As with other 5-HT re uptake inhibitors, animal studies indicate that an interaction between Paroxetine and monoamine oxidase (MAO) inhibitors may occur.
Lithium: Since there is little clinical experience, and there have been reports of interaction of lithium with other 5-HT re-uptake inhibitors, the concurrent administration of Paroxetine and lithium should be undertaken with caution.
Lithium levels should be monitored. Phenytoin / anticonvulsants: Co-administration of Paroxetine and phenytoin is associated with decreased plasma concentrations of Paroxetine and increased adverse experiences. Co-administration of Paroxetine with other anticonvulsants may also be associated with an increased incidence of adverse experiences.
Warfarin: Preliminary data suggest that there may be a pharmacodynamic interaction between Paroxetine and warfarin, which may result in increased bleeding in the presence of unaltered prothrombin times. Paroxetine should therefore be administered with great caution to patients receiving oral anticoagulants.
","Concomitant use in patients taking either monoamine oxidase inhibitors (MAOIs) or thioridazine is contraindicated. This is contraindicated in patients with a hypersensitivity to Paroxetine.
","Major depressive disorder: Asthenia, sweating, nausea, decreased appetite, somnolence, dizziness, insomnia, tremor, nervousness, ejaculatory disturbance and other male genital disorders.
Obsessive compulsive disorder: Nausea, dry mouth, decreased appetite, constipation, dizziness, somnolence, tremor, sweating, impotence and abnormal ejaculation.
Panic disorder: Asthenia, sweating, decreased appetite, decreased libido , tremor, abnormal ejaculation, female genital disorders and impotence.
Social anxiety disorder: Sweating, nausea, dry mouth, constipation, decreased appetite, somnolence, tremor, decreased libido, yawn, abnormal ejaculation, female genital disorders and impotence.
Generalised anxiety disorder: Asthenia, infection, constipation, decreased appetite, dry mouth, nausea, decreased libido, somnolence, tremor, sweating and abnormal
ejaculation.
Post-traumatic stress disorder: Asthenia, sweating nausea, dry mouth, diarrhoea, decreased appetite, somnolence, decreased libido, abnormal ejaculation, female genital disorders and impotence.
","This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Labor and Delivery: The effect of Paroxetine on labor and delivery in humans is unknown.
Nursing Mothers: Like many other drugs, Paroxetine is secreted in human milk, and caution should be exercised when Paroxetine hydrochloride is administered to a nursing woman.
","Cardiac conditions: Paroxetine does not produce clinically significant changes in blood pressure, heart rate and ECG. Nevertheless, as with all psychoactive drugs, caution is advised when treating patients with cardiac conditions.
Epilepsy: As with other antidepressants, Paroxetine should be used with caution in-patients with epilepsy.
Seizures: Overall, the incidence of seizures is < 0.1% in patients treated with Paroxetine. Paroxetine should be discontinued in any patient who develops seizures.
ECT: There is little clinical experience of concurrent administration of Paroxetine with ECT.
Ability to drive/use machines: Clinical experience has shown that therapy with Paroxetine is not associated with impairment of cognitive or psychomotor function. However, as with all psychoactive drugs, patients should be cautioned about their ability to drive a car and operate machinery.
Discontinuation of Treatment with Paroxetine: Recent clinical trials supporting the various approved indications of Paroxetine employed a taper phase regimen, rather than an abrupt discontinuation of treatment. The taper phase regimen used in GAD and PTSD clinical trials involved an incremental decrease in the daily dose by 10 mg/day at weekly intervals. When a daily dose of 20 mg/day was reached, patients were continued on this dose for 1 week before treatment was stopped.
","Dosage for Elderly or Debilitated, and Patients with Severe Renal or Hepatic Impairment: The recommended initial dose is 10 mg/day for elderly patients, debilitated patients, and/or patients with severe renal or hepatic impairment. Increases may be made if indicated. Dosage should not exceed 40 mg/day.
",,,,"Keep out of the reach of children. Store at a cool and dry place. Protect from light and moisture.
",11
+863,Paricalcitol,paricalcitol-863,https://medex.com.bd/attachments/bsPTFkZe2brXGuej9lxECa8obgN6n0/paricalcitol-prescribing-information,Thyroid drugs & hormone,Secondary hyperparathyroidism,"Chronic Kidney Disease Stages 3 and 4: Paricalcitol capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4.
Chronic Kidney Disease Stage 5 ... Read more
Chronic Kidney Disease Stages 3 and 4: Paricalcitol capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4.
Chronic Kidney Disease Stage 5: Paricalcitol capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD).
","Thyroid drugs & hormone
","Paricalcitol is a synthetic, biologically active vitamin D2 analog of calcitriol. Preclinical and in vitro studies have demonstrated that paricalcitol's biological actions are mediated through binding of the VDR, which results in the selective activation of vitamin D responsive pathways. Vitamin D and paricalcitol have been shown to reduce parathyroid hormone levels by inhibiting PTH synthesis and secretion.
","The initial dose of this capsule for CKD stage 3 and 4 patients is based on baseline intact parathyroid hormone (iPTH) levels.
Baseline intact parathyroid hormone (iPTH) Level: <500 pg/ml
+
+- Daily Dose: 1 mcg
+- Daily Dose: 2 mcg
+
+Baseline intact parathyroid hormone (iPTH) Level: >500 pg/ml
+
+- Daily Dose: 2 mcg
+- Daily Dose: 4 mcg
+
",,"
+- Strong CYP3A inhibitors (e.g. ketoconazole) will increase the exposure of paricalcitol. Use with caution.
+- Cholestyramine, Mineral Oil: Intestinal absorption of paricalcitol may be reduced if administered simultaneously with cholestyramine or mineral oil. Take paricalcitol capsules at least 1 hour before or 4 to 6 hours after taking cholestyramine or mineral oil.
+
","Paricalcitol capsules should not be given to patients with evidence of hypercalcemia or vitamin D toxicity.
","The most common adverse reactions (>5% and more frequent than placebo) include diarrhea, nasopharyngitis, dizziness, vomiting, hypertension, hypersensitivity, nausea, and edema.
","Limited data with paricalcitol capsules in pregnant women are insufficient to inform a drug- associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with chronic kidney disease in pregnancy. In animal reproduction studies, slightly increased embryofetal loss was observed in pregnant rats and rabbits administered paricalcitol intravenously during the period of organogenesis at doses 2 and 0.5 times, respectively, the maximum recommended human dose (MRHD). Adverse reproductive outcomes were observed at doses that caused maternal toxicity. There is no information available on the presence of paricalcitol in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production.
","Hypercalcemia: Excessive administration of paricalcitol capsules can cause over suppression of PTH, hypercalcemia, hypercalciuria, hyperphosphatemia, and adynamic bone disease. Prescription-based doses of vitamin D and its derivatives should be withheld during paricalcitol treatment.
Digitalis toxicity: Potentiated by hypercalcemia of any cause. Use caution when paricalcitol capsules are prescribed concomitantly with digitalis compounds.
Laboratory tests: Monitor serum calcium, serum phosphorus, and serum or plasma iPTH during initial dosing or following any dose adjustment. Paricalcitol capsules may increase serum creatinine and therefore decrease the estimated GFR (eGFR).
Aluminum overload and toxicity: Avoid excessive use of aluminum-containing compounds.
",,,,,"keep in a dry place away from light and heat. Keep out of the reach of children.
",10
+1659,Parecoxib,parecoxib-1659,https://medex.com.bd/attachments/aGrOdp0ruLCTsIIXfQNKZX1QULG368/parecoxib-prescribing-information,Non-steroidal Anti-inflammatory Drugs (NSAIDs),Pain,"For the short-term treatment of postoperative pain in adults. The decision to prescribe a selective cyclooxygenase-2 (COX-2) inhibitor should be based on an assessment of the individual patient's overall risks
","Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Parecoxib is a prodrug of valdecoxib. Valdecoxib is a selective COX-2 inhibitor within the clinical dose range. Cyclooxygenase is responsible for generation of prostaglandins. Two isoforms, COX-1 and COX-2, have been identified. COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and central nervous system functions (fever induction, pain perception and cognitive function). It may also play a role in ulcer healing. COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established.
The difference in antiplatelet activity between some COX-1 inhibiting NSAIDs and COX-2 selective inhibitors may be of clinical significance in patients at risk of thrombo-embolic reactions. COX-2 selective inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane. The clinical relevance of these observations has not been established.
","Adult: The recommended dose is 40 mg administered intravenously (IV) or intramuscularly (IM), followed every 6 to 12 hours by 20 mg or 40 mg as required, not to exceed 80 mg/day. As the cardiovascular risk of COX-2 specific inhibitors may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. There is limited clinical experience with Parecoxib treatment beyond three days.
Elderly: No dose adjustment is generally necessary in elderly patients (≥65 years). However, for elderly patients weighing less than 50 kg, treatment should be initiated with half the usual recommended dose of Parecoxib and reduce the maximum daily dose to 40 mg.
Children: The safety and efficacy of parecoxib in children under 18 years old have not been established. No data are available. Therefore, parecoxib is not recommended in these patients.
","The IV bolus injection may be given rapidly and directly into a vein or into an existing IV line. The IM injection should be given slowly and deeply into the muscle. For instructions on reconstitution of the medicinal product before administration. Precipitation may occur when Parecoxib is combined in solution with other medicinal products and therefore Parecoxib must not be mixed with any other medicinal product, either during reconstitution or injection. In those patients where the same IV line is to be used to inject another medicinal product, the line must be adequately flushed prior to and after Parecoxib injection with a solution of known compatibility.
",,"Hypersensitivity to the active substance or to any of the excipients.
","Commonside effects are-
+
+- Change in your blood pressure (up or down)
+- You may get back pain
+- Ankles, legs and feet may swell (fluid retention)
+- You may feel numb- your skin may lose sensitivity to pain and touch
+- You may get vomiting, stomach ache, indigestion, constipation, bloating and wind
+- Tests may show abnormal kidney function
+- You may feel agitated or find it hard to sleep
+- Dizziness
+- There is a risk of anaemia- changes in red blood cells after an operation that may cause fatigue and breathlessness
+- You may get a sore throat or difficulty breathing (shortness of breath)
+- Your skin may be itchy
+- You may pass less urine than usual.
+- Dry socket (inflammation and pain after a tooth extraction)
+- Increased sweating
+- Low levels of potassium in blood test results.
+
","Parecoxib is suspected to cause serious birth defects when administered during the last trimester of pregnancy because as with other medicinal products known to inhibit prostaglandin, it may cause premature closure of the ductus arteriosus or uterine inertia. NSAID use during the second or third trimester of pregnancy may cause foetal renal dysfunction which may result in reduction of amniotic fluid volume or oligohydramnios in severe cases. Such effects may occur shortly after treatment initiation and are usually reversible. Pregnant women on NSAIDs should be closely monitored for amniotic fluid volume. Parecoxib is contraindicated in the third trimester of pregnancy.
Administration of a single dose of parecoxib to lactating women following caesarean section resulted in the transfer of a relatively small amount of parecoxib and its active metabolite valdecoxib into human milk, and this resulted in a low relative dose for the infant (approximately 1% of the weight-adjusted maternal dose). Parecoxib must not be administered to women who breast-feed.
","Parecoxib has been studied in dental, orthopaedic, gynaecologic (principally hysterectomy) and coronary artery bypass graft surgery. There is limited experience in other types of surgery, for example gastrointestinal or urological surgery. Modes of administration other than IV or IM (e.g. intra-articular, intrathecal) have not been studied and should not be used. Because of the possibility for increaed adverse reactions at higher doses of parecoxib, other COX-2 inhibitors and NSAIDs, patients treated with parecoxib should be reviewed following dose increase and, in the absence of an increase in efficacy, other therapeutic options should be considered. There is limited clinical experience with Parecoxib treatment beyond three days. If, during treatment, patients deteriorate in any of the organ system functions described below, appropriate measures should be taken and discontinuation of parecoxib therapy should be considered.
",,"Reporting of overdose with parecoxib has been associated with adverse reactions which have also been described with recommended doses of parecoxib. In case of overdose, patients should be managed by symptomatic and supportive care. Valdecoxib is not removed by haemodialysis. Diuresis or alkalisation of urine may not be useful due to high protein binding of valdecoxib.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+862,Paracetamol + Tramadol Hydrochloride,paracetamol-tramadol-hydrochloride-862,https://medex.com.bd/attachments/NnsAcRIXBMYtkfjUKBC2dB94BIRV4J/paracetamol-tramadol-hydrochloride-prescribing-information,Non-steroidal Anti-inflammatory Drugs (NSAIDs),Renal colic,"This tablet is indicated for-
+
+- The management of moderate to moderately severe pain in adults.
+- The short-term (five days or less) management of acute pain.
+
","Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects of aspirin.
Tramadol is a centrally acting synthetic opioid analgesic. Although its mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: binding of parent and M1 metabolite to μ-opioid receptors and weak inhibition of the reuptake of norepinephrine and serotonin. Opioid activity is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to μ-opioid receptors. Tramadol has been shown to inhibit reuptake of norepinephrine and serotonin in vitro, as have some other opioid analgesics.These mechanisms may contribute independently to the overall analgesic profile of tramadol.
","For the management of moderate to moderately severe pain: The recommended dose is 1 or 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.
In case of short-term (five days or less) management of acute pain: The recommended dose is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.
This tablet can be administered without regard to food.
",,,"Tramadol & Paracetamol combination tablets should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, paracetamol, any other component of this product, or opioids. This is contraindicated in any situation where opioids are contraindicated.
","The following adverse reactions may happen to this therapy: asthenia, fatigue, hot flushes, dizziness, headache, tremor, abdominal pain, constipation, diarrhea, dyspepsia, dry mouth, nausea, vomiting, anorexia, anxiety, confusion, euphoria, insomnia, nervousness, somnolence pruritus, rash, increased sweating etc.
","Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. This combination
preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. This combination preparation is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied.
","
+- This combination preparation may impair mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
+- This combination preparation should not be taken with alcohol containing beverages.
+- The patient should be instructed not to take this combination preparation in combination with other tramadol or paracetamol-containing products, including over-the-counter preparations.
+- This combination preparation should be used with caution when taking medications such as tranquilizers, hypnotics or other opiate containing analgesics.
+
","pediatric use: The safety and effectiveness of this combination preparation have not been studied in the pediatric population.
Geriatric use: In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function; of concomitant disease and multiple drug therapy.
Use in Renal Disease: This combination preparation has not been studied in patients with impaired renal
function. In patients with creatinine clearances of less than 30 ml/min, it is recommended that the dosing interval of this combination preparation be increased but not to exceed 2 tablets every 12 hours.
Use in Hepatic Disease: This combination preparation has not been studied in patients with impaired hepatic function. The use of this combination preparation in patients with hepatic impairment is not recommended.
",,,,"Store in a cool and dry place. Do not freeze. Keep all medicines out of the reach of children.
",10
+861,Paracetamol + Caffeine,paracetamol-caffeine-861,https://medex.com.bd/attachments/lG1s8S4cuUBQrJhd795C6kLvX9HXSY/paracetamol-caffeine-prescribing-information,Non opioid analgesics,Toothache,"The is indicated in the following condition-
+
+- Headache
+- Migraine
+- Toothache
+- Neuralgia
+- Feverishness
+- Period pain
+- Sore throat
+- Backache
+- Help to reduce the temperature
+- Aches and pain of colds and flu
+
","Non opioid analgesics
","This is a combination of Paracetamol and Caffeine. Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Caffeine is an alkaloid which is a theophylline-like xanthine derivative. By intermolecular association with Paracetamol, Caffeine increases the solubility and transmembrane permeation of Paracetamol. In addition, Caffeine increases the pain threshold and tolerance of pain. Caffeine has also an intrinsic power to raise vessel tone in the brain, which provides another benefit to treat migraine and headache.
","Adult dose: 1-2 tablets every 4-6 hours. Maximum dose: 8 tablets daily.
Child dose: Not recommended for children below 12 years.
",,"May reduce serum levels with anticonvulsants (e.g. phenytoin, barbiturates, carbamazepine). May enhance the anticoagulant effect of warfarin and other coumarins with prolonged use. Accelerated absorption with metoclopramide and domperidone. May increase serum levels with probenecid. May increase serum levels of chloramphenicol. May reduce absorption with colestyramine within 1 hr of admin. May cause severe hypothermia with phenothiazine.
","Paracetamol is contraindicated in patients with severe renal function impairment and hepatic disease (Viral Hepatitis). Known hypersensitivity to paracetamol or caffeine.
","Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leukopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.
","Pregnant mothers should consult with doctors before taking Paracetamol & Caffeine. Paracetamol & Caffeine can be taken whilst breast feeding.
","Paracetamol & Caffeine should be given cautiously in the following cases: In patients with hepatic or renal failure, in patients taking other hepatotoxic medication. Prolonged use of the drug without consulting a physician should be avoided.
",,"Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 40 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.
",,,"Store in a cool and dry place, protect from light and moisture.Keep all medicines out of the reach of the children.
",11
+1340,Paracetamol (IV Infusion),paracetamol-iv-infusion-1340,https://medex.com.bd/attachments/5bpKASKy50BXnKuVqRY4RSVut0PAmV/paracetamol-iv-infusion-prescribing-information,,,"Paracetamol IV is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, the reduction of fever.
",,"Paracetamol exhibits analgesic action by peripheral blockage of pain impulse generation. It produces antipyresis by inhibiting the hypothalamic heat-regulating centre. Its weak anti-inflammatory activity is related to inhibition of prostaglandin synthesis in the CNS.
Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Unlike NSAIDs, acetaminophen does not inhibit cyclooxygenase in peripheral tissues and, thus, has no peripheral anti-inflammatory affects. While aspirin acts as an irreversible inhibitor of COX and directly blocks the enzyme's active site, studies have found that acetaminophen indirectly blocks COX, and that this blockade is ineffective in the presence of peroxides. This might explain why acetaminophen is effective in the central nervous system and in endothelial cells but not in platelets and immune cells which have high levels of peroxides. Studies also report data suggesting that acetaminophen selectively blocks a variant of the COX enzyme that is different from the known variants COX-1 and COX-2. This enzyme is now referred to as COX-3. Its exact mechanism of action is still poorly understood, but future research may provide further insight into how it works. The antipyretic properties of acetaminophen are likely due to direct effects on the heat-regulating centres of the hypothalamus resulting in peripheral vasodilation, sweating and hence heat dissipation.
","Adults and adolescents weighing 50 kg and over: the recommended dosage of Paracetamol IV is 1000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of Paracetamol IV of 1000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of Paracetamol of 4000 mg per day.
Adults and adolescents weighing under 50 kg: the recommended dosage of Paracetamol IV is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Paracetamol IV of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Paracetamol of 75 mg/kg per day.
Children >2 to 12 years of age: the recommended dosage of Paracetamol IV is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Paracetamol IV of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Paracetamol of 75 mg/kg per day.
",,,"Paracetamol is contraindicated in patients with known hypersensitivity to its active ingredient or to any of the excipients in the intravenous formulation. Also contraindicated in patients with severe hepatic impairment or severe active liver disease
","As all paracetamol products, adverse drug reactions are rare (>1/10000, <1/1000) or very rare (<1/10000). Frequent adverse reactions at injection site have been reported during clinical trials (pain and burning sensation). Very rare cases of hypersensitivity reactions ranging from simple skin rash or urticaria to anaphylactic shock have been reported and require discontinuation of treatment. Cases of erythema, flushing, pruritus and tachycardia have been reported.
","Pregnancy Category C. There are no studies of intravenous Paracetamol in pregnant women; however, epidemiological data on oral Paracetamol use in pregnant women show no increased risk of major congenital malformations. Animal reproduction studies have not been conducted with IV Paracetamol and it is not known whether Paracetamol IV can cause fetal harm when administered to a pregnant woman. Paracetamol IV should be given to a pregnant woman only if clearly needed. There are no adequate and well-controlled studies with Paracetamol IV during labor and delivery; therefore, it should be used in such settings only after a careful benefit-risk assessment. While studies with Paracetamol IV have not been conducted, Paracetamol is secreted in human milk in small quantities after oral administration.
","Administration of Paracetamol in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death. Do not exceed the maximum recommended daily dose of Paracetamol. Use caution when administering Paracetamol in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia (e.g., due to dehydration or blood loss), or severe renal impairment (creatinine clearance < 30 ml/min). There were infrequent reports of life-threatening anaphylaxis requiring emergent medical attention. Discontinue Paracetamol IV immediately if symptoms associated with allergy or hypersensitivity occurs. Do not use Paracetamol IV in patients with Paracetamol allergy.
","Pediatric Use: The safety and effectiveness of Paracetamol IV for the treatment of acute pain and fever in pediatric patients ages 2 years and older is supported by evidence from adequate and well-controlled studies of Paracetamol IV in adults.
Geriatric use: No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.
Patients with Hepatic Impairment: Paracetamol is contraindicated in patients with severe hepatic impairment or severe active liver disease and should be used with caution in patients with hepatic impairment or active liver disease. A reduced total daily dose of Paracetamol may be warranted.
Patients with Renal Impairment: In cases of severe renal impairment (creatinine clearance < 30 ml/min), longer dosing intervals and a reduced total daily dose of Paracetamol may be warranted.
",,,,"Store in a cool & dry place & away from children. For single use only. The product should be used within 6 hours after opening. Do not refrigerate or freeze.
",9
+859,Pantoprazole Sodium Sesquihydrate,pantoprazole-sodium-sesquihydrate-859,https://medex.com.bd/attachments/AD8GN1yMja7umiVrtTtGVgkkl2TppP/pantoprazole-sodium-sesquihydrate-tablet-oral-suspension-prescribing-information,Proton Pump Inhibitor,Zollinger-Ellison syndrome,"Pantoprazole is indicated where suppression of acid secretion has therapeutic benefit; i.e
+
+- Peptic ulcer diseases
+- Gastroesophageal reflux diseases
+- Ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs)
+- Eradication of Helicobacter pylori (in combination with antibiotics)
+- Zollinger-Ellison Syndrome
+
","Proton Pump Inhibitor
","Pantoprazole is a proton pump inhibitor that suppresses the final step in gastric acid production by covalently binding to the H+/K+ATPase enzyme system at the surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus that persists longer than 24 hours.
","Oral:
+
+- Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed.
+- Gastro-esophageal reflux disease: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed; maintenance dose is 20 mg daily, which may be increased to 40 mg daily.
+- Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.
+- Duodenal ulcer associated with Helicobacter pylori: Pantoprazole is recommended at a dose of 40 mg twice daily in association with antimicrobial agents as detailed below: Amoxycillin 1 g and Clarithromycin 500 mg both twice daily for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice daily for one week.
+- Prophylaxis of NSAID-associated gastric or duodenal ulcer: 20 mg daily for those require long-term NSAID treatment.
+- Zollinger-Ellison Syndrome: Initially 80 mg once daily adjusted according to response (elderly max. 40 mg daily); daily doses above 80 mg given in 2 divided doses.
+
+
IV Injection:
+
+- Duodenal ulcer and gastric ulcer: 40 mg once daily for 7-10 days
+- Gastroesophageal reflux disease associated with a history of erosive esophagitis: 40 mg once daily for 7-10 days
+- Prevention of rebleeding in peptic ulcer: IV 80 mg, followed by 8 mg/hour infusion for 72 hours
+- Prophylaxis of acid aspiration: 80 mg IV every 12 h for 24 h, followed by 40mg every 12 hour
+- Long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: 80 mg IV every 12 hours, may increase to 80 mg every 8 hours if needed, may titrate to higher doses depending on acid output.
+
",,"No significant drug interactions have been observed in clinical studies.
","Pantoprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.
","Pantoprazole is well tolerated in both short-term and long-term treatment. Headache and diarrhea are the common side effects and rarely included side effects are abdominal pain, flatulence, rash, insomnia and hyperglycemia.
","US FDA Pregnancy Category of Pantoprazole is B. There are, however, no adequate and well-controlled studies in pregnant woman. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pantoprazole has been shown to be excreted in human milk. So, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.
","Patients should be cautioned that Pantoprazole tablet should not be split, chewed or crushed. Long-term therapy of Pantoprazole may lead to malabsorption of cyanocobalamin (Vitamin B12) or may increase the risk of osteoporosis related disorders.
",,"There are no known symptoms of overdosage in humans. Since Pantoprazole is highly protein bound, it is not readily dialyzable. Apart from symptomatic and supportive management, no specific therapy is recommended.
",,"Direction for use of IV injection: Pantoprazole lyophilized powder and 0.9% Sodium Chloride Injection is for intravenous administration only and must not be given by any other route. Pantoprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml 0.9% Sodium Chloride Injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes. Use only freshly prepared solution. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours.
Direction for use of IV infusion: Pantoprazole IV infusion should be given as an intravenous infusion over a period of approximately 15 minutes. Pantoprazole IV infusion should be reconstituted with 10 ml of 0.9% Sodium Chloride Injection and further diluted (admixed) with 0.9% Sodium Chloride Injection or 5% Dextrose or Lactated Ringer's Injection to a final volume of 100 ml. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours prior to further dilution. The admixed solution may be stored at room temperature (up to 30° C) and must be used within 24 hours from the time of initial reconstitution.
","Keep in a dry place, away from light and heat. Keep out of the reach of children.
",12
+860,Paracetamol,paracetamol-860,https://medex.com.bd/attachments/CsI57KeeBvXe6wtEdhg2hqnNCHV5OG/paracetamol-tablet-prescribing-information,Non opioid analgesics,Toothache,"Paracetamol is indicated for fever, common cold and influenza, headache, toothache, earache, bodyache, myalgia, neuralgia, dysmenorrhoea, sprains, colic pain, back pain, post-operative pain, postpartum pain, inflammatory pain and post vaccination pain in children. It is also indicated for rheumatic & osteoarthritic pain and stiffness of joints.
","Non opioid analgesics
","Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects of aspirin.
","Tablet:
+
+- Adult: 1-2 tablets every 4 to 6 hours up to a maximum of 4 gm (8 tablets) daily.
+- Children (6-12 years): ½ to 1 tablet 3 to 4 times daily. For long term treatment it is wise not to exceed the dose beyond 2.6 gm/day.
+
+Extended Release Tablet:
+
+- Adults & Children over 12 years: Two tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours).The tablet must not be crushed.
+
+Syrup/Suspension:
+
+- Children under 3 months: 10 mg/kg body weight (reduce to 5 mg/kg if jaundiced) 3 to 4 times daily.
+- 3 months to below 1 year: ½ to 1 teaspoonful 3 to 4 times daily.
+- 1-5 years: 1 -2 teaspoonful 3 to 4 times daily.
+- 6-12 years: 2-A teaspoonful 3 to 4 times daily.
+- Adults: 4-8 teaspoonful 3 to 4 times daily.
+
+Suppository:
+
+- Children 3-12 months: 60-120 mg,4 times daily.
+- Children 1-5 years: 125-250 mg 4 times daily.
+- Children 6-12 years: 250-500 mg 4 times daily.
+- Adults & children over 12 years: 0.5-1 gm 4 times daily.
+
+Paediatric Drop:
+
+- Children Upto 3 months: 0.5 ml (40 mg)
+- 4 to 11 months: 1.0 ml (80 mg)
+- 7 to 2 years: 1.5 ml (120 mg). Do not exceed more than 5 dose daily for a maximum of 5 days.
+
+
Paracetamol tablet with actizorb technology: It dissolves up to five times faster than standard Paracetamol tablets. It is a fast acting and safe analgesic with marked antipyretic property. It is specially suitable for patients who, for any reason, can not tolerate aspirin or other analgesics.
+
+- Adults and children (aged 12 years and over): Take 1 to 2 Tablets every four to six hours as needed. Do not take more than 8 caplets in 24 hours.
+- Children (7 to 11 years): Take ½-1 Tablet every four to six hours as needed. Do not take more than 4 caplets in 24 hours. Not recommended in children under 7 years.
+
",,"Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of Paracetamol. Alcohol can increase the hepatotoxicity of Paracetamol overdosage. Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic Paracetamol levels by increasing first-pass metabolism or clearance.
","It is contraindicated in known hypersensitivity to Paracetamol.
","Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.
","Pregnancy category B according to USFDA. This drug should be used during pregnancy only if clearly needed
","Paracetamol should be given with caution to patients with impaired kidney or liver function. Paracetamol should be given with care to patients taking other drugs that affect the liver.
",,"Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12-48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.
",,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",11
+858,Pancuronium Bromide,pancuronium-bromide-858,https://medex.com.bd/attachments/F0H9af9gJDFhSTND1phDJfNUB4W5pk/pancuronium-bromide-prescribing-information,Non depolarizing muscle relaxants,Vomiting,"Pancuronium is indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgical procedure of medium and long duration.
","Non depolarizing muscle relaxants
","Pancuronium is a typical non-depolarising curare-mimetic muscle relaxant. It acts as a competitive acetylcholine antagonist on neuromuscular junctions, displacing acetylcholine (hence competitive) from its post-synaptic nicotinic acetylcholine receptors. It is, unlike suxamethonium, a non-depolarising agent, which means, that it causes no spontaneous depolarisations upon association with the nicotinic receptor in neuromuscular junction, thus producing no muscle fasciculations upon administration. Pancuronium has no hormonal activity. It exerts slight vagolytic activity (i.e. diminishing activity of the vagus nerve) and no ganglioplegic (i.e., blocking ganglions) activity.
Nondepolarizing neuromuscular blocking agents inhibit neuromuscular transmission by competing with acetylcholine for the cholinergic receptors of the motor end plate, thereby reducing the response of the end plate to acetylcholine. This type of neuromuscular block is usually antagonized by anticholinesterase agents.
","Intravenous:
+Facilitate endotracheal intubation, Muscle relaxant in general anaesthesia:
+
+- Adult: Initially, 50-100 mcg/kg by inj, may reduce to 20-60 mcg/kg if given after suxamethonium. Maintenance: 10-20 mcg/kg.
+- Child: 0-30 days Initially, 30-40 mcg/kg. Maintenance: 10-20 mcg/kg; >1 mth Same as adult dose.
+
+Facilitate mechanical ventilation in intensive care:
+
+- Adult: 60 mcg/kg every 1-1.5 hr or less frequently.
+
",,"Increased effect with inhalational anaesth, other non-depolarising muscle relaxants, antibiotics (polypeptide and aminoglycoside group), diazepam, propranolol, thiamine (high dose), MAOIs, quinidine, Mg sulfate, protamine, nitroglycerin, narcotic analgesics, diuretics, phenytoin, α and β adrenergic blockers, imidazoles, norepinephrine and epinephrine and prior suxamethonium. Decreased effect with neostigmine, edrophonium, corticosteroids (high dose); KCl, Ca chloride and NaCl; heparin (temporary decrease), azathioprine, theophylline, pyridostigmine, neurolept analgesia and propanidid.
","Pancuronium must not be administered to patients with know hypersensitivity to puncuronium of the bromide ion.
","Tachycardia, HTN, bradycardia, bronchospasm, hypotension, CV collapse, excessive salivation; pain or local skin reactions at inj site. Rarely, hypersensitivity reactions.
","Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Patient with burn injury, biliary tract disease, pulmonary disease, muscular dystrophies, myasthenia gravis, myasthenic syndrome, electrolyte disturbance, altered pH, dehydration, CV disease, oedema, raised catecholamine concentration and those at risk of HTN. Renal and hepatic impairment. Childn. Pregnancy and lactation.
","Obese patient: Adjust dose based on ideal body wt.
Renal Impairment:
+
+- Haemodialysis/peritoneal dialysis patient: Avoid use.
+- Continuous renal replacement therapy: 50% of normal dose.
+- CrCl (mL/min) <10: Avoid use.
+- CrCl (mL/min) 10-50: 50% of normal dose.
+
","Symptoms: Prolonged apnoea, resp depression and/or muscle weakness. Death may follow acute resp failure.
Management: May administer neostigmine 2.5 mg and atropine 1.2 mg to reverse neuromuscular block while ventilation is continued. When admin of the anticholinesterase agent fails to reverse neuromuscular blockade, continue ventilation until spontaneous breathing is restored.
",,,,11
+857,Pancreatin,pancreatin-857,,Digestive Enzyme,Pancreatic insufficiency,"Pancreatin is employed for the treatment of patients with
+
+- Chronic pancreatitis
+- Cystic fibrosis/Mucoviscidosis
+- Following partial or complete pancreatectomy
+- Total gastrectomy
+- Steatorrhea
+- Somatostatinoma
+- Celiac disease and
+- Other conditions associated with pancreatic insufficiency
+
","Digestive Enzyme
","Pancreatin is a preparation of Pancreatin, an extract from mammalian pancreas containing enzymes with Amylase, Protease and Lipase activity. It is designed to disintegrate in the alkaline medium of the duodenum where it releases the active enzyme components of Pancreatin (Amylase, Protease and Lipase). Amylase hydrolyzes dietary starch to yield maltose, maltoriose and a-dextrin. Protease cleaves peptide bonds in the center of proteins and polypeptides and forms amino acids and oligopeptides. Lipase hydrolyzes dietary triglycerides forming two molecules of fatty acid and a molecule of beta-monoglyceride. It converts not less than 25 times its weight of starch into soluble carbohydrates and not less than 25 times its weight of casein into proteoses within 5 mins, (equivalent to 150 times in 30 mins).
","2-3 tablets to be swallowed whole with little water immediately after or during meal. Or as directed by the physician
",,"Alkaline media will rupture the enteric coating. As such to prevent bursting out of the content in the stomach Pancreatin should not be used concurrently with antacid.
","Pancreatin is contraindicated in patients with known hypersensitivity to the drug.
","The most frequent side effects are gastrointestinal including nausea, vomiting and abdominal discomfort. Buccal and perianal soreness may occur, particularly in infants. Hypersensitivity reactions manifested by sneezing, lacrimation or skin rashes have been reported.
","Pancreatin should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Pancreatin is administered to a nursing mother.
","Patients known to be allergic to animal protein should be treated with caution.
",,"Excessive dosage may produce a laxative effect. Systemic toxicity does not occur. Very high dosage may cause hyperuricaemia and hyperuricosuria
",,,"Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.
",11
+856,Palonosetron,palonosetron-856,https://medex.com.bd/attachments/ApXY0AVif4HDrkofhSwPrbDEM2Qg75/palonosetron-injection-prescribing-information,Anti-emetic drugs,Vomiting,"Palonosetron indicated in-
+
+- Acute and delayed nausea and vomiting
+- Uncontrolled nausea and vomiting
+- Chemotherapy-induced nausea and vomiting (CINV): Acute CINV resulting in on the day of treatment with certain types of chemotherapy
+- Delayed CINV resulting in on days later with certain types of chemotherapy
... Read more
Palonosetron indicated in-
+
+- Acute and delayed nausea and vomiting
+- Uncontrolled nausea and vomiting
+- Chemotherapy-induced nausea and vomiting (CINV): Acute CINV resulting in on the day of treatment with certain types of chemotherapy
+- Delayed CINV resulting in on days later with certain types of chemotherapy
+- Radiotherapy-induced nausea and vomiting (RINV)
+- Post-operative & Post-discharge nausea and vomiting (PONV & PDNV).
+
","Anti-emetic drugs
","Palonosetron is a 5-HT3 receptor antagonist with a strong binding affinity for this receptor and little or no affinity for other receptors. It is thought that chemotherapeutic agents produce nausea and vomiting by releasing serotonin from the enterochromaffin cells of the small intestine and that the released serotonin then activates 5-HT3 receptors that are located on the nerve terminals of the vagus in the periphery and centrally in the chemoreceptor trigger zone of the area postrema, to initiate the vomiting reflex. Postoperative nausea and vomiting is influenced by multiple patient, surgical and anesthesia related factorcs and is triggered by release of 5-HT3 in a cascade of neuronal event involving both the central nervous system and the gastrointestinal tract. The 5-HT3 receptor has been demonstrated to selectively participate in the emetic response. Palonosetron works by blocking the actions of Serotonin, associated with nausea and vomiting, at 5-HTs receptor. It is likely that Palonosetron works in the small intestine but it may also work in the brain.
Pharmacokinetics: Palonosetron exhibits linear dose-proportional pharmacokinetics over the doserange 1-90 pg/kg in healthy subjects and in patients with cancer. In cancer patients receiving single intravenous doses of Palonosetron in this dose range, the mean maximum plasma concentration (Cmax) ranges from 0.89 to 336 ng/ml and the area under the plasma concentration-time curve from zero to infinity (AUCo-co) ranges from 13.8 to 957 ng.h/ml. Palonosetron has a volume of distribution of approximately 6.9-7.9 L/kg, with approximately 62% bound to plasma proteins. Approximately 50% of Palonosetron is metabolized into two inactive metabolites that exhibit <1% of the 5-HT3 receptor antagonist activity. Approximately 40% of the drug is metabolised via kidney, 50% by liver CYP2D6 (mainly), CYP3A4 and CYP1A2 isoenzymes. About 50% of the drug goes under metabolism. After a single intravenous dose, approximately 40% is excreted as unchanged drug in the urine after 144 hours. Total body clearance of Palonosetron is 160±35 ml/h/kg, and renal clearance is 66.5±18.2 ml/h/kg in healthy subjects. Palonosetron exhibits a longer half-life (40 hours) and has a greater 5-HT3 receptor binding affinity.
","Usual dosage: Adult tablet dosage: 0.5 mg daily. Adult IV dosage: A single IV dose of 0.075 mg should be administered over 10 seconds.
Chemotherapy-induced nausea and vomiting: Adult tablet dosage: 0.5 mg administered approximately 1 hour prior to the start of chemotherapy. Adult IV dosage: A single IV dose of 0.25 mg should be administered over 30 seconds approximately 30 minutes before the start of chemotherapy.
Radiotherapy-induced nausea and vomiting: A single IV dose of 0.25 mg should be administered over 30 seconds approximately 30 minutes before each week of radiation fraction.
Post-operative nausea and vomiting: A single IV dose of 0.075 mg should be administered over 10 seconds immediately before induction of anesthesia.
Children dosage: (1 month to 17 years): A single IV dose at 20 mcg/kg body weight. Which maximum dose is 1.5 mg.
",,"In controlled clinical trials, Palonosetron injection has been safely administered with corticosteroids, analgesics, antiemetics/antinauseants, antispasmodics and anticholinergic agents. Palonosetron did not inhibit the antitumor activity of cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C in murine tumor models. Concomitant administration of Palonosetron and metoclopramide has no significant pharmacokinetic interactions. In vitro studies indicated that palonosetron is not inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2D6, CYP2E1 & CYP3A4/5 (CYP2C19 was not investigated) nor does it induce the activity of CYP1A2, CYP2D6 or CYP3A4/5. Therefore, the potential for clinically significant drug interactions with Palonosetron appears to be low.
","Palonosetron is contraindicated in patients known to have hypersensitivity to the drug or any of its components.
","The most common adverse reactions are headaches and constipation.
","Pregnancy category 'B'. It is not known whether Palonosetron is excreted in breast milk.
",,"Use in elderly patients: No dosage adjustment is recommended in elderly patients >65 years of age.
Use in Children: (1 month to 10 years): A single IV dose at 20 mcg/kg body weight. Which maximum dose is 1.5 mg.
Use in patients with impaired renal and hepatic function: No dosage adjustment is recommended in patients with renal and hepatic dysfunction.
","There is no known antidote to Palonosetron. Overdose should be managed with supportive care.
",,,"Store in a cool & dry place, protected from light.
",11
+1555,Paliperidone Palmitate,paliperidone-palmitate-1555,https://medex.com.bd/attachments/w7anpmmeU3WtALI7C0gOrsVNdyPkV5/paliperidone-palmitate-prescribing-information,Atypical neuroleptic drugs,Schizoaffective Disorder,"Paliperidone Palmitate is an atypical antipsychotic indicated for
+
+- Treatment of schizophrenia in adults.
+- Treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants.
+
","Atypical neuroleptic drugs
","Paliperidone palmitate is hydrolyzed to paliperidone. Paliperidone is the major active metabolite of risperidone. The mechanism of action of paliperidone is unclear. However, the drug’s therapeutic effect in schizophrenia could be mediated through a combination of central dopamine Type 2 (D2 ) and serotonin Type 2 (5HT 2A ) receptor antagonism.
In vitro, paliperidone acts as an antagonist at the central dopamine Type 2 (D2) and serotonin Type 2 (5HT 2A) receptors with binding affinities (Ki values) of 1.6-2.8 nM for D 2 and 0.8-1.2 nM for 5HT 2A receptors. Paliperidone is also active as an antagonist at the α 1 and α 2 adrenergic receptors and H 1 histaminergic receptors, which may explain some of the other effects of the drug. Paliperidone has no affinity for cholinergic muscarinic or β1 and β2-adrenergic receptors. The pharmacological activity of the (+)- and (-)- paliperidone enantiomers is qualitatively and quantitatively similar in vitro.
","Schizophrenia:
+
+- Initiation Dosing: Day 1-234 mg and Day 8-156 mg
+- Monthly Maintenance Dose: 39-234 mg
+- Maximum Monthly Dose: 234 mg
+
+Schizoaffective disorder:
+
+- Initiation Dosing: Day 1-234 mg and Day 8-156 mg
+- Monthly Maintenance Dose: 78-234 mg
+- Maximum Monthly Dose: 234 mg
+
+Administered 5 weeks after the first injection. The recommended maintenance dose for treatment of schizophrenia is 117 mg. Some patients may benefit from lower or higher maintenance doses within the additional available strengths (39 mg, 78 mg, 156 mg, and 234 mg). Adjust dose based on tolerability and/or efficacy using available strengths. The 39 mg strength was not studied in the long-term schizoaffective disorder study.
","For intramuscular injection only. Each injection must be administered only by a healthcare professional. For deltoid injection, use 1-inch 23G needle for patients weighing less than 90 kg or 1 ½-inch 22G needle for patients weighing 90 kg or more. For gluteal injection, use 1 ½-inch 22G needle regardless of patient weight.
","Drugs that may cause orthostatic hypotension: An additive effect may occur when co-administered with Paliperidone Palmitate
Strong CYP3A4/P-glycoprotein (P-gp) inducers: Avoid using a strong inducer of CYP3A4 and/or P-gp (e.g., carbamazepine, rifampin, St John’s Wort) during a dosing interval for Paliperidone Palmitate. If administering a strong inducer is necessary, consider managing the patient using paliperidone extended release tablets
","Known hypersensitivity to paliperidone, risperidone, or to any excipients in Paliperidone Palmitate
","The most common adverse reactions (incidence ≥ 5% and occurring at least twice as often as placebo) were injection site reactions, somnolence/sedation, dizziness, akathisia, and extrapyramidal disorder.
","Limited data from published literature report the presence of paliperidone in human breast milk. There is no information on the effects on the breastfed infant or the effects on milk production
","Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g. stroke, transient ischemic attack).
Neuroleptic Malignant Syndrome: Manage with immediate discontinuation of drug and close monitoring.
QT Prolongation: Avoid use with drugs that also increase QT interval and in patients with risk factors for prolonged QT interval.
Tardive Dyskinesia: Discontinue drug if clinically appropriate.
Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia and weight gain.
Orthostatic Hypotension and Syncope: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope.
Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts (CBC) in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. Consider discontinuing Paliperidone Palmitate if clinically significant decline in WBC in the absence of other causative factors.
Hyperprolactinemia: Prolactin elevations occur and persist during chronic administration.
Potential for Cognitive and Motor Impairment: Use caution when operating machinery.
Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold.
","Pediatric Use: Safety and effectiveness of Paliperidone Palmitate in patients <18 years of age have not been established.
Renal Impairment: Not recommended in patients with moderate or severe renal impairment
Hepatic Impairment: Paliperidone has not been studied in patients with hepatic impairment. Based on a study with oral paliperidone, no dose adjustment is required in patients with mild or moderate hepatic impairment.
",,,,"Store at room temperature; excursions between 15°C and 30°C are permitted. Do not mix with any other product or diluent.
",12
+1371,Paliperidone,paliperidone-1371,https://medex.com.bd/attachments/gnLsNZi5a5LUkJyDseiXTcEMc7j7TW/paliperidone-prescribing-information,Atypical neuroleptic drugs,Schizoaffective Disorder,"Paliperidone extended release tablet is indicated for-
+
+- Schizophrenia, including acute treatment and recurrence prevention
+- Treatment of schizoaffective disorder as monotherapy and in combination with antidepressants or mood stabilizers
+
","Atypical neuroleptic drugs
","Paliperidone is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. Paliperidone is the major active metabolite of Risperidone. It is a centrally active dopamine Type 2 (D2) antagonist and with predominant serotonin Type 2 (5-HT2A) antagonist activity. It is also active as an antagonist at α1 and α2 adrenergic receptors and H1 histaminergic receptors, which may explain some of the other effects of the drug. It has no affinity for cholinergic muscarinic or β1-and β2-adrenergic receptors.
","Schizophrenia:
+
+- Adults: Initial dose is 6 mg/day. Recommended dose is 3-12 mg/day, Maximum dose is 12 mg/day
+- Adolescents (Weight <51kg): Initial dose is 3 mg/day, Recommended dose is 3-6 mg/day, Maximum dose is 6 mg/day
+- Adolescents (Weight ≥51kg): Initial dose is 3 mg/day, Recommended dose is 3-12 mg/day, Maximum dose is 12 mg/day
+
+
Schizoaffective disorder: adults Initial dose is 6 mg/day. Recommended dose is 3-12 mg/day, Maximum dose is 12 mg/day.
","Paliperidone extended release tablet can be taken with or without food. It must be swallowed whole with the aid of liquids. Tablets should not be chewed, divided or crushed.
","
+- Paliperidone should be used with caution in combination with other centrally acting drugs and alcohol. It may antagonize the effect of Levodopa and other dopamine agonists.
+- Because of its potential for inducing orthostatic hypotension, an additive effect may be observed when Paliperidone is administered with other therapeutic agents that have this potential.
+- Strong CYP3A4/P-glycoprotein (P-gp) inducers: It may be necessary to increase the dose of Paliperidone when a strong inducer of both CYP3A4 and P-gp (e.g., carbamazepine) is co-administered. Conversely, on discontinuation of the strong inducer, it may be necessary to decrease the dose of Paliperidone.
+- Co-administration of divalproex sodium increased Cmax and AUC of Paliperidone by approximately 50%. Adjust dose of Paliperidone if necessary based on clinical assessment.
+
",,"The most common adverse reactions of Paliperidone are tachycardia, akathisia, somnolence, tremor, dystonia, cogwheel rigidity, anxiety, weight increased, dyspepsia, constipation, nasopharyngitis etc.
","Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Paliperidone should be used during pregnancy only if the potential benefits justifies the potential risk to the fetus. Paliperidone is excreted in human breast milk. The known benefits of breastfeeding should be weighed against the unknown risks of infant exposure to Paliperidone.
","Caution should be exercised when Paliperidone is prescribed in patients with known Cardiovascular diseases, QT prolongation, Neuroleptic malignant syndrome, Tardive dyskinesia, Hyperglycemia, Dyslipidemia, Obesity, Hyperprolactinemia, Leukopenia, Neutropenia, Agranulocytosis, Seizures, Potential for Cognitive & Motor impairment etc.
","Pediatric use: Safety and effectiveness in the treatment of schizophrenia not established in patients less than 12 years of age. Safety and effectiveness in the treatment of schizoaffective disorder not established in patients less than 18 years of age.
","Overdose of Paliperidone is limited; there is no specific antidote to Paliperidone. If overdose occurs general supportive and symptomatic measures should be employed.
",,,"Store in a cool and dry place, away from light. Keep out of reach of children.
",12
+1390,Palbociclib,palbociclib-1390,https://medex.com.bd/attachments/bKGNKH5r4I3ZUArDg7AAzWG8xYBNuQ/palbociclib-prescribing-information,,Endocrine Disorders,"Palbociclib is a kinase inhibitor indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:
+
+- An aromatase inhibitor as initial endocrine-based therapy in postmenopausal women; or
+- Fulvestrant in women with disease progression following endocrine therapy.
+
",,"Palbociclib is an inhibitor of Cyclin-dependent kinases (CDK) 4 and 6. cyclin D1 and CDK4/6 are downstream of signaling pathways that lead to cellular proliferation. Palbociclib reduced cellular proliferation of Estrogen receptor (ER)-positive breast cancer cell lines by blocking progression of the cell from G1 into s phase of the cell cycle. Treatment of breast cancer cell lines with the combination of Palbociclib and antiestrogens leads to decreased retinoblastoma (RB) protein phosphorylation resulting in reduced E2F expression and signaling, and increased growth arrest compared to treatment with each drug alone. Treatment of ER-positive breast cancer cell lines with the combination of Palbociclib and antiestrogens led to increased cell senescence compared to each drug alone, which was sustained for up to 6 days following Palbociclib removal and was greater if antiestrogen treatment was continued. In vivo studies using a patient-derived ER-positive breast cancer xenograft model demonstrated that the combination of Palbociclib and letrozole increased the inhibition of RB phosphorylation, downstream signaling, and tumor growth compared to each drug alone.
","The recommended dose of Palbociclib is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. Palbociclib should be taken with food. Patients should be encouraged to take their dose of Palbociclib at approximately the same time each day. For men treated with combination Palbociclib plus aromatase inhibitor therapy, consider treatment with an LHRH agonist according to current clinical practice standards.
Recommended Dose Modification for Adverse Reactions:
+
+- Recommended Starting Dose: 125 mg/day
+- First Dose Reduction: 100 mg/day
+- Second Dose Reduction: 75 mg/day
+
+If further dose reduction below 75 mg/day is required, discontinue. Or, as directed by the registered physician.
Use in Children: Palbociclib is not indicated for use in children.
",,"Palbociclib is primarily metabolized by CYP3A and Sulfotransferase (SULT) enzyme SULT2A1. Palbociclib is a
time-dependent inhibitor of CYP3A.
Agents That May Increase Palbociclib Plasma Concentrations: Effect of CYP3A-Inhibitors: Coadministration of a strong CYP3A inhibitor (Itraconazole) increased the plasma exposure of Palbociclib in patients by 87%. Avoid concomitant use of strong CYP3A inhibitors (e.g., Clarithromycin, Indinavir, Itraconazole, Ketoconazole, Lopinavir/Ritonavir, Nefazodone, Nelfinavir, Posaconazole, Ritonavir, Saquinavir, Telaprevir, Telithromycin, And Voriconazole). Avoid grapefruit or grapefruit juice during Palbociclib treatment. If coadministration of Palbociclib with a strong CYP3A inhibitor cannot be avoided, reduce the dose of Palbociclib.
Agents That May Decrease Palbociclib Plasma Concentrations: Effect of CYP3A Inducers: Coadministration of a strong CYP3A Inducer (Rifampin) decreased the plasma exposure of Palbociclib in healthy subjects by 85%. Avoid concomitant use of strong CYP3A inducers (E.G., Phenytoin, Rifampin, Carbamazepine, Enzalutamide, and St John’s Wort).
Drugs That May Have Their Plasma Concentrations Altered By Palbociclib: Coadministration of Midazolam with multiple doses of Palbociclib increased the Midazolam plasma exposure by 61%, in patients, compared to administration of Midazolam alone. The dose of the sensitive CYP3A substrate with a narrow therapeutic index (e.g., Alfentanil, Cyclosporine, Dihydroergotamine, Ergotamine, Everolimus, Fentanyl, Pimozide, Quinidine, Sirolimus, And Tacrolimus) may need to be reduced, as Palbociclib may increase its exposure.
",,"Common side effects of Palbociclib include: WBC decreased, Neutrophils decreased, Neutropenia, Platelets decreased, infections, AST increased, ALT increased, Leukopenia, Fatigue, Nausea, Hair loss, Inflammation of the mouth and lips, Diarrhea, Anemia, Rash, Weakness/lethargy, Vomiting, Thrombocytopenia, Dry skin, Fever.
","Palbociclib can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.
","Neutropenia: Neutropenia was the most frequently reported adverse reaction. Monitor complete blood counts prior to starting Palbociclib therapy and at the beginning of each cycle, as well as on day 15 of the first 2 cycles, and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop grade 3 or 4 neutropenia. Febrile neutropenia has been reported in 1.8% of patients exposed to Palbociclib. One death due to neutropenic sepsis was observed. Physicians should inform patients to promptly report any episodes of fever.
Embryo-Fetal Toxicity: Palbociclib can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Palbociclib and for at least 3 weeks after the last dose.
",,"There is no known antidote for Palbociclib. The treatment of overdose of Palbociclib should consist of general supportive measures.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+95,Padimate O + Avobenzone + Oxybenzone + Titanium dioxide,padimate-o-avobenzone-oxybenzone-titanium-dioxide-95,,Sunblock Preparation,Vitiligo,"This combination is indicated for-
+
+- Normal skin types when exposed to intense sunlight
+- Photodermatoses including those caused by radiotherapy
+- Photosensitisation
+- Solar urticaria
+- Acute solar dermatitis
+- Drug-induced photosensitivity
+- Acute lupus erythematosus
... Read more
This combination is indicated for-
+
+- Normal skin types when exposed to intense sunlight
+- Photodermatoses including those caused by radiotherapy
+- Photosensitisation
+- Solar urticaria
+- Acute solar dermatitis
+- Drug-induced photosensitivity
+- Acute lupus erythematosus
+- Herpes simplex
+- Polymorphic light eruption
+- Cutaneous albinism
+- Vitiligo
+
","Sunblock Preparation
","This lotion is a non-greasy, water resistant, protective sun block, which helps prevent sunburn in all types of skin. It provides a high degree of protection against the harmful effects of ultraviolet components of sunlight which are responsible for skin cancer, wrinkling, premature ageing and darkening of the skin due to overexposure.
This provides a sun protection factor (SPF) of 6 against UVA rays and 28 against UVB rays. The SPF describes how much longer you can remain in the sun without being affected by these rays, compared with unprotected skin. This gives you 28 times more natural sunburn protection and maintains its degree of protection up to 60 minutes in water.
","This lotion should be applied carefully and evenly on skin before sun exposure. Apply 45 minutes before swimming or sweat producing exercise. A single application may give day-long protection but the product should be re-applied during prolonged periods of sunning and after swimming or excessive sweating.
",,"There are no known drug interactions and none well documented.
","Known hypersensitivity to any of its components.
","Signs of irritations (including erythema, burning or rash) may appear when applied to sensitive or broken skin.
","This lotion should only be used if the anticipated benefits outweigh the risks.
","Application to broken skin should be avoided. Contact with the eyes and other mucous membranes should be avoided.
",,,,,,9
+855,Paclitaxel,paclitaxel-855,https://medex.com.bd/attachments/jBZpXNcgVhjhNAaTQTcACK0KtV1NJc/paclitaxel-prescribing-information,,,"Ovarian Carcinoma: Paclitaxel is indicated as first line and subsequent therapy for the treatment of advanced carcinoma of the ovary. As first line therapy, Paclitaxel is indicated in combination with cisplatin.
Breast Carcinoma: Paclitaxel is indicated for ... Read more
Ovarian Carcinoma: Paclitaxel is indicated as first line and subsequent therapy for the treatment of advanced carcinoma of the ovary. As first line therapy, Paclitaxel is indicated in combination with cisplatin.
Breast Carcinoma: Paclitaxel is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. Paclitaxel is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracline unless clinically contraindicated. Paclitaxel is indicated for the first-line therapy of advanced or metastatic breast cancer either in combination with an anthracycline in patients for whom anthracline therapy is suitable or in combination with trastuzumab in patients who overexpress HER2 at a 2+ or 3+ level as determined by immuno-histochemistry.
Gemcitabine, in combination of Paclitaxel, is indicated in the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated.
Paclitaxel is indicated for the treatment of metastatic cancer of the breast, in combination with trastuzumab, in patients who have tumors that over-express HER2 and who have not received previous chemotherapy for their metastatic disease.
Non-Small Cell Lung Carcinoma: Paclitaxel, in combination with cisplatin, is indicated for the first line treatment of non-small cell lung cancerin patients who are not candidates for potential curative surgery and/or radiation therapy.
Kaposi's Sarcoma: Paclitaxel is indicated for the second line treatment of AIDS related Kaposi's Sarcoma.
Gastric Carcinoma: Paclitaxel is indicated for the treatment of Gastric Carcinoma.
",,"Paclitaxel is a novel anti-microtubule agent that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. In addition, paclitaxel induces abnormal arrays or “bundles” of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis. Following intravenous administration of Paclitaxel, paclitaxel plasma concentrations declined in a biphasic manner. The initial rapid decline represents distribution to the peripheral compartment and elimination of the drug. The later phase is due, in part, to a relatively slow efflux of paclitaxel from the peripheral compartment.
","All patients should be premedicated prior to Paclitaxel administration in order to prevent severe hypersensitivity reactions. Such premedication may consist of dexamethasone 20 mg PO administered approximately 12 and 6 hours before Paclitaxel, diphenhydramine (or its equivalent) 50 mg IV 30 to 60 minutes prior to Paclitaxel, and cimetidine (300 mg) or ranitidine (50 mg) IV 30 to 60 minutes before Paclitaxel.
First-line treatment of ovarian cancer: Although alternative medication regimens for paclitaxel are under investigation at present, a combination therapy of paclitaxel and cisplatin is recommended. Depending on the duration of infusion, two different dosages are recommended for paclitaxel treatment: 175 mg/m2 of paclitaxel is administered as an intravenous infusion over a period of three hours followed thereafter by 75 mg/m2 of cisplatin and the therapy is repeated at 3-week intervals, or 135 mg/m2 of paclitaxel is administered as an intravenous infusion over a period of 24 hours followed thereafter by 75 mg/m2 of cisplatin and the therapy is repeated at 3-week intervals.
Second-line treatment of ovarian cancer: The recommended dose of paclitaxel is 175 mg/m2 administered over 3 hours, with a 3-week interval between courses.
Adjuvant chemotherapy in breast carcinoma: The recommended dose of paclitaxel is 175 mg/m2 administered over a period of 3 hours every 3 weeks for four courses, following AC therapy.
First-line chemotherapy of breast carcinoma: When used in combination with doxorubicin (50 mg/m2), paclitaxel should be administered 24 hours after doxorubicin. The recommended dose of paclitaxel is 220 mg/m2 administered intravenously over a period of 3 hours, with a 3-week interval between courses. When used in combination with trastuzumab, the recommended dose of paclitaxel is 175 mg/m2 administered intravenously over a period of 3 hours, with a 3-week interval between courses. Paclitaxel infusion may be started the day following the first dose of trastuzumab or immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab was well tolerated.
Second-line chemotherapy of breast carcinoma: The recommended dose of paclitaxel is 175 mg/m2 administered over a period of 3 hours, with a 3-week interval between courses.
Advanced non-small-cell lung cancer: The recommended dose of paclitaxel is 175 mg/m2 administered over 3 hours followed by 80 mg/m2 of cisplatin, with a 3-week interval between courses.
Treatment of AIDS-related KS: The recommended dose of paclitaxel is 100 mg/m2 administered as a 3-hour intravenous infusion every two weeks.
Dose adjustment: Subsequent doses of paclitaxel should be administered according to individual patient tolerance. Paclitaxel should not be re-administered until the neutrophil count is >1.5 x 109/1 (>1 x 109/1 for KS patients) and the platelet count is >100 x 109/1 (>75 x 109/1 for KS patients).
",,"Paclitaxel clearance is not affected by cimetidine premedication.
Cisplatin: Administration of paclitaxel after cisplatin treatment leads to greater myelosuppression and about a 20% decrease in paclitaxel clearance. Patients treated with paclitaxel and cisplatin may have an increased risk of renal failure as compared to cisplatin alone in gynecological cancers.
Doxorubicin: Since the elimination of doxorubicin and its active metabolites can be reduced when paclitaxel and doxorubicin are given closer in time, paclitaxel for initial treatment of metastatic breast cancer should be administered 24 hours after doxorubicin. Sequence effects characterized by more profound neutropenic and stomatitis episodes have been observed with combination use of paclitaxel and doxorubicin when paclitaxel was administered before doxorubicin and using longer than recommended infusion times (paclitaxel administered over 24 hours; doxorubicin over 48 hours).
Active substances metabolized in the liver: The metabolism of paclitaxel is catalysed, in part, by cytochrome P450 isoenzymes CYP2C8 and CYP3A4. Therefore, in the absence of a PK drug-drug interaction study, caution should be exercised when administering paclitaxel concomitantly with medicines known to inhibit either CYP2C8 or CYP3A4 (e.g. ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, clopidogrel, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir) because toxicity of paclitaxel may be increased due to higher paclitaxel exposure. Administering paclitaxel concomitantly with medicines known to induce either CYP2C8 or CYP3A4 (e.g. rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine) is not recommended because efficacy may be compromised because of lower paclitaxel exposures.
","
+- Paclitaxel is contraindicated in patients with severe hypersensitivity reactions to paclitaxel, macrogolglycerol ricinoleate (polyoxyl castor oil.)
+- Paclitaxel is contraindicated during lactation.
+- Paclitaxel should not be used in patients with baseline neutrophils <1.5x109/I (<1x109/I for KS patients) or platelets <100x109/I (<75x109/I for KS patients).
+- In KS, paclitaxel is also contraindicated in patients with concurrent, serious, uncontrolled infections.
+- Patients with severe hepatic impairment must not be treated with paclitaxel.
+
","Common: Low blood counts leading to increased risk for infection, anemia and/or bleeding, hair loss, arthralgias and myalgias, pain in the joints and muscles, peripheral neuropathy, nausea, vomiting (usually mild), diarrhea, Mouth sores, hypersensitivity reaction, fever, facial flushing, chills, shortness of breath, or hives after paclitaxel is given.
Rare: swelling of the feet or ankles (edema), liver problems, low blood pressure, darkening of the skin where previous radiation treatment has been given.
","Pregnancy Category D. There is no adequate data from the use of paclitaxel in pregnant women, however as with other cytotoxic medicinal products, paclitaxel may cause foetal harm when administered to pregnant women. Paclitaxel is contraindicated during lactation.
","Paclitaxel should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Since significant hypersensitivity reactions may occur, appropriate supportive equipment should be available. Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during drug administration. Paclitaxel should be given before cisplatin when used in combination.
Significant hypersensitivity reactions, as characterised by dyspnoea and hypotension requiring treatment, angioedema, and generalised urticaria have occurred in <1% of patients receiving paclitaxel after adequate premedication. Fatal hypersensitivity reactions have occurred in patients despite premedication. These reactions are probably histamine-mediated. In the case of severe hypersensitivity reactions, paclitaxel infusion should be discontinued immediately.
Bone marrow suppression, primarily neutropenia, is the dose-limiting toxicity. Neutrophil nadirs occurred at a median of 11 days. Frequent monitoring of blood counts should be instituted. Patients should not be retreated until the neutrophil count is ≥1.5 x 109/1 (≥1 x 109/1 for KS patients) and the platelets recover to ≥100 x 109/1 (≥75 x 109/1 for KS patients).
Severe cardiac conduction abnormalities have been reported rarely with single agent paclitaxel. If patients develop significant conduction abnormalities during paclitaxel administration, appropriate therapy should be administered and continuous cardiac monitoring should be performed during subsequent therapy with paclitaxel.
","Patients who experience severe neutropenia: (neutrophil count <0.5 x 109/1 for a minimum of 7 days) or severe peripheral neuropathy, should receive a dose reduction of 20% for subsequent courses (25% for KS patients).
Patients with hepatic impairment: Inadequate data are available to recommend dosage alterations in patients with mild to moderate hepatic impairments. Patients with severe hepatic impairment must not be treated with paclitaxel.
Pediatric use: Paclitaxel is not recommended for use in children below 18 years due to lack of data on safety and efficacy
","There is no known antidote for paclitaxel overdose. In case of overdose, the patient should be closely monitored. Treatment should be directed at the primary anticipated toxicities, which consist of bone marrow suppression, peripheral neurotoxicity and mucositis. Overdoses in paediatric patients may be associated with acute ethanol toxicity.
",,"Preparation for Intravenous Infusion: Paclitaxel Injection must be diluted prior to infusion. Paclitaxel should be diluted in 0.9% Sodium Chloride Injection, USP; 5% Dextrose Injection, USP; 5% Dextrose and 0.9% Sodium Chloride Injection, USP; or 5% Dextrose in Ringer’s Injection to a final concentration of 0.3 to 1.2 mg/ml. The solutions are physically and chemically stable for up to 27 hours at ambient temperature (below 30°C) and room lighting conditions. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
","Keep in a dry place and store below 30°C. Protect from light and keep out of the reach of children. Use only freshly prepared solution.
",12
+1800,Ozenoxacin,ozenoxacin-1800,https://medex.com.bd/attachments/PTJDLZjqSCSsSSdwpL6fWvJuuCFYrn/ozenoxacin-prescribing-information,Topical Antibiotic preparations,Impetigo,"Ozenoxacin is indicated for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients 2 months of age and older.
","Topical Antibiotic preparations
","Mechanism of Action: Ozenoxacin is a quinolone antimicrobial drug. The mechanism of action involves the inhibition of bacterial DNA replication enzymes, DNA gyrase A and topoisomerase IV. Ozenoxacin has been shown to be bactericidal against S. aureus and S. pyogenes organisms.
Absorption: Four pharmacokinetic studies were conducted in 110 patients utilizing varying strengths of ozenoxacin cream, up to 2% (twice the concentration of the marketed formulation). Three of these studies assessed systemic absorption in healthy subjects and in subjects with impetigo. These studies were conducted with either single or repeated application of up to 1 g ozenoxacin cream to intact or abraded skin (up to 200 cm2 surface area). No systemic absorption was observed in 84 of 86 subjects, and negligible systemic absorption was observed at the level of detection (0.489 ng/mL) in 2 subjects.
Distribution: Plasma protein binding of ozenoxacin was moderate (~80 to 85%) and did not appear to be dependent on concentration. Since negligible systemic absorption was observed in clinical studies, tissue distribution has not been investigated in humans.
Metabolism: Ozenoxacin was not metabolized in the presence of fresh human skin discs and was minimally metabolized in human hepatocytes.
Excretion: Studies have not been investigated in humans due to the negligible systemic absorption observed in clinical studies.
","Apply a thin layer of Ozenoxacin topically to the affected area twice daily for five days. The affected area may be up to 100 cm
2 in adult and pediatric patients 12 years of age and older or 2% of the total body surface area and not exceeding 100 cm
2 in pediatric patients less than 12 years of age.
+
+- Wash hands after applying Ozenoxacin cream.
+- Ozenoxacin cream is for topical use only.
+- Not for oral, ophthalmic, intranasal, or intravaginal use.
+- The treated area may be covered with a sterile bandage or gauze dressing.
+
",,,"None
","Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety profile of Ozenoxacin was assessed in two clinical trials (Trial 1 and Trial 2) in 362 adult and pediatric patients two months of age and older with impetigo. The patients used at least one dose from a 5-day, twice a day regimen of Ozenoxacin. Control groups included 361 patients who used placebo and 152 patients who used retapamulin ointment. The median age of the patients enrolled in the clinical trials was 10 years; 3 % of patients were 2 months to less than 2 years of age, 55 % of patients were 2 to less than 12 years of age, 11 % of patients were 12 to less than 18 years of age, and 31 % of patients were 18 years of age or older. Adverse reactions (rosacea and seborrheic dermatitis) were reported in 1 adult patient treated with Ozenoxacin.
","Pregnancy: There are no available data on the use of ozenoxacin in pregnant women to inform a drug associated risk. Systemic absorption of ozenoxacin in humans is negligible following topical administration of ozenoxacin (up to twice the concentration of the marketed formulation). Due to the negligible systemic exposure, it is not expected that maternal use of ozenoxacin will result in fetal exposure to the drug. Animal reproduction studies were not conducted with ozenoxacin. However, toxicity studies conducted in pregnant rats and rabbits administered the oral form of ozenoxacin showed no significant adverse developmental effects (at >10,000 times the maximum human plasma concentration seen with dermal application of ozenoxacin). The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Lactation: No data are available regarding the presence of ozenoxacin in human milk, and the effects of ozenoxacin on the breastfed infant or on milk production. However, breastfeeding is not expected to result in exposure of the child to ozenoxacin due to the negligible systemic absorption of ozenoxacin in humans following topical administration of ozenoxacin. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ozenoxacin and any potential adverse effects on the breast-fed child from ozenoxacin or from the underlying maternal condition.
","Potential for Microbial Overgrowth: The prolonged use of Ozenoxacin may result in overgrowth of nonsusceptible bacteria and fungi. If such infections occur during therapy, discontinue use and institute appropriate supportive measures.
","Pediatric Use: The safety and effectiveness of ozenoxacin in the treatment of impetigo have been established in pediatric patients 2 months to 17 years of age. Use of ozenoxacin in pediatric patients (2 months to 17 years of age) is supported by evidence from adequate and well-controlled studies of ozenoxacin in which 251 pediatric patients received at least one dose of ozenoxacin. The median age of the patients enrolled in the clinical trials was 10 years; 3% of patients were 2 months to less than 2 years of age, 55 % of patients were 2 to less than 12 years of age, 11% of patients were 12 to less than 18 years of age, and 31 % of patients were 18 years of age or older. In these studies, the maximum dose applied was approximately 0.5 g of ozenoxacin applied twice daily for up to 5 days (i.e., up to 10 applications total). The safety profile of ozenoxacin in pediatric patients 2 months and older was similar to that of adults. The safety and effectiveness of ozenoxacin in pediatric patients younger than 2 months of age have not been established.
Geriatric Use: Clinical studies of ozenoxacin did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
","Any sign or symptom of overdose, either topically or by accidental ingestion, should be treated symptomatically. No specific antidote is known.
",,,"Store at 20ºC - 25ºC; excursions permitted to 15ºC to 30ºC. Keep away from light & moisture. Keep out of the reach of children.
",11
+854,Oxytocin,oxytocin-854,https://medex.com.bd/attachments/dt9DaHyoeDh3JQ7dDaqs5ybn7oUfam/oxytocin-prescribing-information,Drugs acting on the Uterus,Uterine atony,"In Antepartum:
+
+- Induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, (pre-) eclampsia at or near term, when delivery is in the best interests of mother and fetus or when membranes are prematurely ruptured and delivery is indicated;
... Read more
In Antepartum:
+
+- Induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, (pre-) eclampsia at or near term, when delivery is in the best interests of mother and fetus or when membranes are prematurely ruptured and delivery is indicated;
+- Stimulation or reinforcement of labor, as in selected cases of uterine inertia;
+- As adjunctive therapy in the management of incomplete or inevitable abortion.
+
+In Postpartum:
+
+- Oxytocin is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.
+
","Drugs acting on the Uterus
","Uterine motility depends on the formation of the contractile protein actomyosin under the influence of the Ca2+ dependent phosphorylating enzyme myosin light-chain kinase. Oxytocin promotes contractions by increasing the intracellular Ca2+, which in turn activates myosin's light chain kinase. Oxytocin has specific receptors in the muscle lining of the uterus and the receptor concentration increases greatly during pregnancy, reaching a maximum in early labor at term.
","Induction or Stimulation of Labor:
+
+- The standard solution for infusion of Oxytocin is prepared by adding the contents of one 1ml vial containing 10 units of Oxytocin to 1000 ml of infusion fluids. The combined solution containing 10 mU (1mU=0.001U) of Oxytocin/ml is rotated in the infusion bottle for thorough mixing.
+- The initial dose should be 0.5-1 mU/min (equal to 3-6 ml of the dilute Oxytocin solution per hour). At 30-60 minutes intervals the dose should be gradually increased in increments of 1-2 mU/min until the desired contraction pattern has been established. Once the desired frequency of contractions has been reached and labor has progressed to 5-6 cm dilation, the dose may be reduced by similar increments.
+- At term, higher infusion rates should be given with great care and rates exceeding 9-10 mU/min are rarely required.
+- Before term, when the sensitivity of the uterus is lower because of a lower concentration of Oxytocin receptors, a higher infusion rate may be required.
+
+Control of Postpartum Uterine Bleeding:
+
+- Intravenous Infusion (Drip Method): To control postpartum bleeding, 10 to 40 units of Oxytocin may be added to the bottle, depending on the amount of infusion fluids solution remaining (maximum 40 units to 1000 ml). Adjust infusion rate to sustain uterine contraction and control uterine atony.
+- Intramuscular Administration: 1 mL (10 units) of Oxytocin can be given after the delivery of the placenta.
+
+Treatment of Incomplete or Inevitable Abortion:
+
+- Intravenous infusion of 10 units of Oxytocin added to 500 ml of a 0.9% sodium chloride solution may help the uterus contract after a suction or sharp curettage for an incomplete, inevitable or elective abortion.
+- Subsequent to intra-amniotic injection of hypertonic saline, prostaglandins, urea etc., for mid trimester elective abortion, the injection-to-abortion time may be shortened by infusion of Oxytocin at the rate of 10 to 20 mU (20 to 40 drops) per minute. The total dose should not exceed 30 units in a 12-hour period due to the risk of water intoxication.
+
",,"Severe hypertension has been reported when Oxytocin was given three to four hours following prophylactic administration of a vasoconstrictor in conjunction with caudal-block anesthesia. Cyclopropane anesthesia may modify Oxytocin’s cardiovascular effects, so as to produce unexpected results such as hypotension. Maternal sinus bradycardia with abnormal atrioventricular rhythms has also been noted when Oxytocin was used concomitantly with cyclopropane anesthesia.
","This drug is contraindicated in- significant cephalopelvic disproportion; unfavorable fetal positions or presentations which are undeliverable without conversion prior to delivery, e.g., transverse lies; in obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention; in cases of fetal distress where delivery is not imminent; hypertonic uterine patterns; hypersensitivity to the drug. Prolonged use in uterine inertia or severe toxemia is contraindicated. Oxytocin should not be used in cases where vaginal delivery is not indicated.
","
+- Hypersensitivity to the drug may result in uterine hypertonicity, spasm, titanic contraction or rupture of the uterus.
+- The possibility of increased blood loss and afbrinigenemia should be kept in mind when administering the drug.
+- Severe water intoxication with convulsions and coma has occurred.
+- Oxytocin may occasionally cause nausea, vomiting, haemorrhage or cardiac arrhythmias, anaphylactic reaction.
+
","Pregnancy category C. It is not known whether Oxytocin is excreted in human milk
","Oxytocin should not be administered in the following conditions: prematurity, borderline cephalopelvic disproportion, previous major surgery on the cervix or uterus including caesarean section, overdistention of the uterus, grand multiparity or invasive cervical carcinoma.
",,"Overdosage with Oxytocin depends essentially on uterine hyperactivity whether or not due to hypersensitivity to this agent. Hyperstimulation with strong (hypertonic) or prolonged (tetanic) contractions, or a resting tone of 15 to 20 mm H2O or more between contractions can lead to tumultuous labor, uterine rupture, cervical and vaginal lacerations, postpartum hemorrhage, utero-placental hypoperfusion, and variable deceleration of fetal heart, fetal hypoxia, hypercapnia, or death. Water intoxication with convulsions, which is caused by the inherent antidiuretic effect of Oxytocin, is a serious complication that may occur if large doses (40 to 50 mU/minute) are infused for long periods. Management consists of immediate discontinuation of Oxytocin and symptomatic and supportive therapy.
",,"Infusion Fluids-
+
+- 0.9% Sodium Chloride solution
+- 5% Dextrose-in-water solution
+- Ringer’s solution
+- Hartmann’s solution (Ringer-lactate)
+
","Store in between 2 to 8°C, in dark & frost free place. Keep out of the reach of children.
",12
+881,Phenoxymethyl Penicillin [Penicillin V],phenoxymethyl-penicillin-penicillin-v-881,https://medex.com.bd/attachments/Bu17bgznm5em21YrpCBQwlEeHAWdEo/phenoxymethyl-penicillin-penicillin-v-tablet-prescribing-information,Benzylpenicillin & Phenoxymethyl penicillin,Vincent’s infection,"For the treatment of mild to moderately severe bacterial infections, if these are due to penicillin susceptible pathogens and respond to therapy with oral penicillin, such as:
+
+- infections of the ear, nose and throat regions, e.g., tonsillitis, pharyngitis, laryngitis, otitis media, sinusitis.
... Read more
For the treatment of mild to moderately severe bacterial infections, if these are due to penicillin susceptible pathogens and respond to therapy with oral penicillin, such as:
+
+- infections of the ear, nose and throat regions, e.g., tonsillitis, pharyngitis, laryngitis, otitis media, sinusitis.
+- infections of the lower respiratory tract, e.g., bronchitis and pneumonia, bronchopneumonia.
+- infections due to beta-hemolytic streptococci of group A, e.g., scarlet fever, erysipelas, rheumatic fever.
+- skin infections, e.g., pyodermia, furunculosis, phlegmon, erysipeloid, erythema migrans, insofar as the micro-organisms are penicillin-susceptible.
+- lymphadenitis and lymphangitis of bacterial origin.
+- infections of the buccal cavity, gums or jaws, e.g., inflammatory infiltrates, delayed dentition stages II and III, antral fistulae, secondary bacterial infection with Gram-positive pathogens following virus-induced gingivitis or stomatitis.
+
+For prophylaxis of scarlet fever; also to prevent recurrences of rheumatic fever. For prophylaxis of infection after dental and oral surgical procedures or dental extractions in certain high risk patients (e.g. with congenital cardiac defects, artificial heart valves, rheumatic endocarditis). In some cases, combination with another appropriate antibiotic may be indicated.
","Benzylpenicillin & Phenoxymethyl penicillin
","Phenoxymethyl penicillin or penicillin V is acid-stable and is absorbed from the upper part of the small intestine. Of different forms of Phenoxymethyl penicillin, the potassium salt of Phenoxymethyl penicillin is best absorbed. This may be given with meals but maximum absorption is achieved when drug is administered orally at least 1 hour before or 2 hours after the meal. Phenoxymethyl penicillin offers a very convenient means of treating Grampositive infections. Phenoxymethyl penicillin has the distinct advantage over penicillin G in resistance to inactivation by gastric acid.
","The dosage of Phenoxymethyl penicillin should be determined according to the sensitivity of the causative micro-organism and the severity of the infection, and adjusted to the clinical response of the patient.
Adults: 250-500 mg 6 hourly
Children (above 1 year):
+
+- 125-250 mg 6 hourly
+- 125 mg/5 ml powder for suspension: 1-2 teaspoonful (5-10 ml) 6 hourly
+- 250 mg/5 ml powder for suspension: ½-1 teaspoonful (2.5-5 ml) 6 hourly
+
+
Infants (below 1 year):
+
+- 62.5-125 mg 6 hourly.
+- 125 mg/5 ml powder for suspension: ½-1 teaspoonful (2.5-5 ml) 6 hourly, or as prescribed by the physician.
+
+Phenoxymethyl penicillin is best taken with an empty stomach, preferably at least 1 hour before or 2 hour after meal.
","Phenoxymethyl Penicillin is best taken on an empty stomach, preferably one hour before meals. The tablets are swallowed without chewing with sufficient amounts of liquid. Before each use of this syrup, the bottle has to be shaken vigorously.
","Food: Concurrent intake of food leads to a reduction in the rate of absorption. Therefore, Phenoxymethyl penicillin is best taken on an empty stomach, preferably one hour before meals, in order to reach the highest possible rate of absorption.
Drug interactions: Concomitant administration of penicillins may lead to increased levels of methotrexate in serum and potentiate its toxic effects. Monitoring of methotrexate serum levels is therefore necessary.
If diarrhoea occurs as a consequence of treatment with Phenoxymethyl penicillin, the absorption of other orally administered drugs may be disturbed and their effcacy may consequently be impaired. If penicillins are combined with bacteriostatic chemotherapeutics or antibiotics (e.g., tetracyclines, chloramphenicol), the activity of penicillins may be attenuated or abolished. Concurrent administration of probenecid inhibits the renal excretion of penicillins. Concurrent use of indomethacin, phenylbutazone, salicylates or sulfinpyrazone may cause elevated and prolonged serum levels of phenoxymethylpenicillin.
Administration of penicillins may cause a transient reduction in plasma concentrations of oestrogens and gestagens. The effectiveness of oral contraceptives is therefore uncertain.
The absorption of Phenoxymethyl penicillin may be reduced where intestinal sterilization with aminoglycosides (e.g. neomycin) has just been performed or is still in progress. Combined use of penicillins and oral anticoagulants (e.g. warfarin) may prolong prothrombin time/INR.
Interference with laboratory and diagnostic tests: Non-enzymatic urine glucose determinations and tests for urobilinogen may give false-positive results.
","Phenoxymethyl Penicillin must not be administered in patients with hypersensitivity to penicillins or any of the excipients of this. Phenoxymethyl Penicillin must not be used to treat patients with severe gastrointestinal disorders accompanied by vomiting and diarrhea.
","Occasionally, hypersensitivity reactions involving the skin (e.g. urticaria, morbilliform or scarlatiniform rashes, pruritus), eosinophilia or more serious allergic reactions, e.g. drug fever, vasculitis, serum sickness or interstitial nephritis, may develop. Anaphylactic or anaphylactoid reactions accompanied by, e.g- angioneurotic oedema, oedema of the larynx, bronchial spasm and shock may occur.
In the event of signs pointing to anaphylactic/anaphylactoid reactions, the treatment must be terminated immediately. In occasional instances, there may be skin rashes or inflammation of mucous membranes, especially in the region of the mouth (stomatitis); dryness of the mouth and disorders of taste may rarely occur.
The occurrence of severe bullous skin reactions- usually involving the mucosae- has been reported in isolated cases (Stevens-Johnson syndrome, Lyell's syndrome). Gastrointestinal disturbances with, e.g., nausea, vomiting, abdominal pain, loose stools, or diarrhoea may develop.
Diarrhoea may sometimes be a symptom of enterocolitis which may, in some cases, be haemorrhagic. A particular form of enterocolitis that can occur with antibiotics is pseudomembranous colitis (in most cases due to Clostridium diffcile). This must be considered in patients in whom severe, persistent diarrhoea occurs during treatment or in the initial weeks thereafter. Even if pseudomembranous colitis is only suspected, administration of Phenoxymethyl penicillin must be halted immediately. This type of colitis requires immediate and appropriate treatment by a physician. Drugs that inhibit intestinal peristalsis must not be taken in such cases. In isolated cases, particularly after high doses and prolonged administration, changes in blood picture such as reduction in the number of white blood cells (e.g.,leucopenia, granulocytopenia, agranulocytosis), erythrocytes (e.g., due to haemolytic anaemia), thrombocytes, or pancytopenia and myelosuppression may occur. During treatment for spirochaetal infections, Herxheimer's reaction characterized by the occurrence or worsening of general symptoms such as fever, chills, headache, and joint pains may develop. In isolated cases, drug-induced aseptic meningitis may occur.
In extremely rare cases, transient discolouration of the teeth may be seen during treatment with Phenoxymethyl penicillin. Administration of antibiotics, especially if prolonged, may lead to the proliferation of resistant micro organisms.
Beta-lactams predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment.
","Phenoxymethylpenicillin crosses the placenta. Given the appropriate indication, this may be used at any time throughout pregnancy. Phenoxymethylpenicillin passes into the breast milk in small amounts. This may be used during lactation; however, diarrhoea and yeast colonization of mucous membranes may occur in the infant.
","The possibility of cross-allergy between cephalosporins and penicillins must be considered. When treating patients with heart diseases or serious electrolyte disturbances of other origin, the potassium content of Phenoxymethyl Penicillin may have to be considered. Beta-lactams predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment.
Administration of antibiotics, especially if prolonged, may lead to the proliferation of resistant micro-organisms. The patient's condition must therefore be checked at regular intervals. If a secondary infection occurs, appropriate measures must be taken. In patients with diabetes mellitus, the sugar content of Phenoxymethyl Penicillin syrup must be taken into consideration.
There is no indication of impaired ability to drive, or to operate machinery. Beta-lactams predispose the patient to encephalopathy risk. In the case of adverse reactions such as encephalopathy (which may include convulsions, confusion, impairment of consciousness, movement disorders), the patient should not operate machines or drive a vehicle.
",,"The toxicity of phenoxymethylpenicillin is low, and it has a broad therapeutic range. When a multiple therapeutic dose is taken orally once only, phenoxymethylpenicillin has no acute toxicity. There is a risk of encephalopathy in cases of administration of beta-lactam antibiotics, particularly in case of overdose or renal impairment. Special measures in the event of overdosage, other than discontinuation of the medication, are not required. Elimination of phenoxymethylpenicillin can be accomplished through haemodialysis.
",,,"Store in a cool and dry place, protect from light.
",12
+879,Phenobarbital,phenobarbital-879,,Adjunct anti-epileptic drugs,Tonic-clonic status epilepticus,"Phenobarbital is indicated for the following conditions:
+
+- Sedatives
+- Hypnotics for the short-term treatment of insomnia
+- Pre-anesthetics
+- Long-term anticonvulsants for the treatment of generalized tonic-clonic and cortical local seizures. And, in the emergency control of certain acute convulsive episodes, (those associated with status epilepticus, eclampsia meningitis, tetanus, and toxic reactions to Strychnine or local anesthetics).
+
","Adjunct anti-epileptic drugs, Barbiturates
","Phenobarbital, the longest-acting barbiturate, is used for its anticonvulsant and sedative-hypnotic properties in the management of all seizure disorders except absence (petit mal). Phenobarbital acts on GABAA receptors, increasing synaptic inhibition. This has the effect of elevating seizure threshold and reducing the spread of seizure activity from a seizure focus. Phenobarbital may also inhibit calcium channels, resulting in a decrease in excitatory transmitter release. The sedative-hypnotic effects of phenobarbital are likely the result of its effect on the polysynaptic midbrain reticular formation, which controls CNS arousal.
","Suggested doses of Phenobarbital for specific indications are as follows:
Pediatric Oral Dosage:
+
+- Preoperative: 1 mg to 3 mg/kg.
+- Anticonvulsant: 1 mg to 6 mg/kg per day
+
+Adult Oral Dosage:
+
+- Daytime sedative: 30 mg to 120 mg daily in 2 to 3 divided doses.
+- Bedtime hypnotic: 100 mg to 320 mg.
+- Anticonvulsant: 50 mg to 100 mg 2 to 3 times daily.
+
+Pediatric Injection Dosage:
+
+- 15 to 20 mg/kg IV over 10 to 15 min.
+- Preoperative Sedation:1 to 3 mg/kg IM/IV;
+- Anticonvulsant: 4 to 6 mg/kg IM/IV per day, for 10 days. Alternatively, use 10 to 15 mg/kg IM/IV per day to reach therapeutic level more quickly. Maxium IV rate 60 mg/min.
+
+Adult Injection Dosage:
+
+- Insomnia: 100 to 320 mg IM/IV;
+- Convulsions: 100 to 320 mg IV. Repeat if needed (maximum, 600 mg per day);
+- Status Epilepticus: 10 to 20 mg/kg IV. Repeat if needed.
+
",,"The concomitant use of Alcohol or other CNS depressants may produce additive CNS depressant effects.
","Phenobarbital is contraindicated in patients with known Phenobarbital sensitivity or a history of latent porphyria.
","The most common adverse reaction is somnolence. Other less frequent adverse reactions are agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, thinking abnormality, apnea, bradycardia, hypotension, nausea, vomiting and constipation.
","Pregnancy Category D. Phenobarbital can cause fetal damage when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be in risk of the potential hazard to the fetus. Caution should be taken when Phenobarbital is administered to a nursing woman since small amounts of Phenobarbital are excreted in the milk.
","Tolerance and psychological and physical dependence may occur with continuing use. Phenobarbital should be administered with caution to patients who are mentally depressed, have suicidal tendencies, or a history of drug abuse. In patients with hepatic damage, Phenobarbital should be administered with caution and initially reduced doses.
",,"The toxic dose of barbiturates varies considerably. In general, an oral dose of 1 gram of most barbiturates produces serious poisoning in an adult. Death commonly occurs after 2 to 10 grams of ingested barbiturate. Acute overdosage with barbiturates is manifested by CNS and respiratory depression Treatment of overdosage is mainly supportive and immediate hospitalization is necessary.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+878,Pheniramine Maleate,pheniramine-maleate-878,https://medex.com.bd/attachments/XBXaHE8r1lvPoUwm4kKcemc95CiXqF/pheniramine-maleate-prescribing-information,Sedating Anti-histamine,Motion sickness,"Pheniramine Maleate is indicated for-
+
+- Allergic conditions including hay fever, drug rashes, angioneurotic edema, serum sickness, allergic conjunctivitis, food allergy etc.
+- Conditions of the respiratory tract that are accompanied by increased secretion, including vasomotor rhinitis and acute rhinitis.
... Read more
Pheniramine Maleate is indicated for-
+
+- Allergic conditions including hay fever, drug rashes, angioneurotic edema, serum sickness, allergic conjunctivitis, food allergy etc.
+- Conditions of the respiratory tract that are accompanied by increased secretion, including vasomotor rhinitis and acute rhinitis.
+- All itching skin conditions, including neurodermatitis, eczema of any origin, lichen planus, acute and chronic urticaria, pruritis of the anus or genitals, pruritus in icterus and diabetes, radiation sickness etc.
+- Prevention and treatment of motion sickness.
+- Prevention and treatment of nausea, vomiting and vertigo due to Meniere’s disease and other labyrinthine disturbances.
+
","Sedating Anti-histamine
","Pheniramine competes with histamine for the histamine H1 receptor, acting as an inverse agonist once bound. The reduction in H1 receptor activity is responsible for reduced itching as well as reduced vasodilation and capillary leakage leading to less redness and edema. This can be seen in the suppression of the histamine-induced wheal (swelling) and flare (vasodilation) response. Inverse agonism of the H1 receptor in the CNS is also responsible for the sedation produced by first-generation antihistamines like pheniramine. The binding of pheniramine to H4 receptors, and subsequent inverse agonism, may also contribute to reduced itching by antagonizing inflammation.
","Doses must be individually determined in all cases and should be taken with or soon after food. Treatment should be commenced at the lowest possible dose because experience has shown that antihistamines are often effective at low doses. The maximum dose of 3 mg/kg per day should not be exceeded. Elderly patients should use the adult dose with caution.
To prevent travel sickness, it is recommended that the first dose be taken at least 30 minutes before traveling. Due to the risk of drowsiness, the patient should not drive a motor vehicle or operate machinery after taking a dose.
Pheniramine Maleate tablets:
+
+- In adults and children over 10 years of age: Treatment is commenced with half a tablet taken up to three times daily. This dose may be increased to one tablet taken up to three times daily if required.
+- Children 5-10 years of age: Half a tablet up to three times daily. Pheniramine Maleate tablets are not recommended in children under 5 years of age.
+
",,"
+- MAO-inhibitors may prolong and intensify the anticholinergic effect of pheniramine (see Contraindications).
+- Adverse CNS effects of pheniramine may be enhanced when it is taken with alcohol or other CNS depressants (eg. hypnotics, sedatives, tranquilizers).
+- Atropine and related drugs may enhance the anticholinergic activity of pheniramine.
+
","
+- Patients with hypersensitivity to pheniramine or any other ingredient (eg. Methyl hydroxybenzoate or propyl hydroxybenzoate in the syrup).
+- Patients with symptomatic prostatic hypertrophy.
+- Patients receiving MAO-inhibitor therapy.
+- Newborn and premature infants.
+
","The most common adverse reaction is sedation, which often disappears after a few days if tolerance is acquired. Hypersensitivity reactions have been reported.
+
+- Central Nervous System: Lassitude, dizziness, tinnitus, inability to concentrate, incoordination, irritability, insomnia and tremors. Agitation and convulsions, especially in children and restlessness, disorientation and hallucinations in adults, are common symptoms following overdose.
+- Gastrointestinal: Nausea, vomiting, diarrhoea, colic, epigastric pain, anorexia, dryness of mouth and constipation.
+- Genitourinary: Urinary retention.
+- Cardiovascular: Palpitations, headache.
+- Ocular: Blurred vision, increased intraocular pressure.
+- Musculoskeletal: Muscular weakness.
+- Haematological: Rare cases of blood dyscrasias including agranulocytosis and haemolytic anaemia have been reported.
+
","pregnancy Category A. Use only if strictly indicated. Use only if strictly indicated.
","
+- Pheniramine Maleate may cause drowsiness. Both the dosage and the time of administration should be carefully considered in patients whose activities (e.g. driving a car or operating machinery) demand special concentration.
+- Patients should be cautioned against the simultaneous ingestion of alcohol and other central nervous system depressants. Pheniramine Maleate may possibly be hallucinogenic in toxic doses. Due to the possible CNS stimulating effects of antihistamines, pheniramine has the potential for abuse.
+- Due to the anticholinergic effect of pheniramine, caution and close monitoring are required if it is used in patients with conditions such as prostatic hypertrophy, narrow angle glaucoma, asthma or severe cardiovascular disease.
+- The anti-emetic effect of pheniramine may mask the signs of other conditions. Products containing pheniramine should not be taken on an empty stomach.
+
",,"Symptoms: Antihistamine drugs in toxic doses produce a complex of CNS excitatory and depressant effects. Accidental ingestion in small children has resulted in convulsions and sometimes death.
Management: As there is no specific antidote, treatment should be symptomatic and supportive. Induction of vomiting should only be used immediately after ingestion as the sedative action of any absorbed antihistamine can lead to life-threatening pulmonary aspiration during emesis. Gastric lavage with a cuffed endotracheal tube in situ may be useful for some time after ingestion of antihistamines as their anticholinergic action slows down gastric emptying. Stimulants should not be used as they may precipitate convulsions. Diazepam or short-acting barbiturates may be used to control convulsions. Vasopressors may be used to treat hypotension. Mechanical support of respiration may be required if respiration is seriously depressed. Continuous ECG monitoring is recommended if cardiac toxicity develops, which can be treated with centrally-acting anticholinesterases such as physostigmine.
",,,"Store in a cool and dry place, protected from light. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.
",11
+877,Pethidine Hydrochloride,pethidine-hydrochloride-877,https://medex.com.bd/attachments/aIux2FV6nOgpXow41BivNwwRXdLdBa/pethidine-hydrochloride-prescribing-information,Opioid analgesics,Post-operative pain,"Pethidine is indicated for short-term (24-36 hours) relief of moderate to severe pain. It can be given via the following routes of administration: intramuscular, subcutaneous, slow intravenous bolus injection, intravenous infusion and patient controlled analgesia (PCA).
Pethidine is indicated ... Read more
Pethidine is indicated for short-term (24-36 hours) relief of moderate to severe pain. It can be given via the following routes of administration: intramuscular, subcutaneous, slow intravenous bolus injection, intravenous infusion and patient controlled analgesia (PCA).
Pethidine is indicated for administration as an anaesthetic adjunct and for obstetric analgesia. An opioid antagonist and facilities for administration of oxygen and control of respiration should be immediately available during and immediately following intravenous administration of pethidine
","Opioid analgesics
","Pethidine is a phenylpiperidine derivative opioid analgesic. It acts mainly as mu-receptor agonist. Like most, opioid analgesics, it mimics endogenous opioids by activating opioid receptors in the central and peripheral nervous system. It reduces the release of neurotransmitter substances and also reduces the activity of postsynaptic neurons in the spinal cord thus preventing transmission of pain impulse.
","Adult Dosage:
+
Analgesia:
+
+- Dosage should be adjusted according to the severity of pain and the response of the patient and also depends on patient profile eg: age, weight, sex, previous exposure to narcotics.
+- 25 to 100 mg by IM (preferred) or S.C. injection, every 3 to 4 hours.
+- 25 to 50 mg slow IV injection, every 3 to 4 hours
+- Usual dose is 200 mg/day by the IV route. Intravenous injection should be made very slowly, preferably using a diluted solution.
+- For continuous intravenous infusion adequate analgesia should be established prior to commencement of the infusion. A dosage of 0.3 mg/kg/hr is recommended as the initial intravenous infusion rate.
+- Clinical experience suggests that patients with normal renal function receiving more than 1000 mg/24 hrs pethidine are at particular risk of developing pethidine associated neurotoxicity (PAN). Patients receiving over 800 mg/24 hrs pethidine should usually be monitored for early signs of norpethidine toxicity
+
+
Obstetric Analgesia: 50 to 100 mg by IM (preferred) or S.C. injection, administered when pain becomes regular. May be repeated 3 to 4 times at one to three hour intervals if necessary. Maximum of 4 doses in 24 hours
Anaesthesia Adjunct: As premedication, intramuscular (preferred) or subcutaneous, 50 to 100 mg thirty to ninety minutes prior to anaesthesia. As an adjunct to anaesthesia, intravenous, by repeated slow injection of fractional doses of a solution diluted to 10 mg per mL. Dosage by this route should not exceed 25 to 50 mg. Dosage must be titrated to the needs of the patient, depending on the premedication given, the type of anaesthesia, and the nature and duration of the surgical procedure.
Patient-Controlled Analgesia:
+
+- Patient-controlled analgesia (PCA) allows patients to assess their own level of pain and consequently titrate the amount of pethidine they require for adequate pain control against sedation and other side effects. Adequate analgesia should be established prior to commencement of PCA.
+- The dosages and time intervals are preset into a microprocessor-controlled infusion pump. When the patient experiences pain, a button is depressed by the patient and a dose of pethidine is administered intravenously. If the patient should depress the button before the preset time interval (lockout interval) has elapsed, no extra drug is administered. For adults, demand doses, of 5 mg to a maximum of 20 mg pethidine have been given via PCA using a lockout interval of 6 to 20 minutes. Along with the self-administered dose of pethidine, some syringe pumps also deliver a background continuous infusion of pethidine at a basal rate. Some PCA pumps allow a maximum dosage over a defined period to be preset in order to avoid patient overdosage.
+- The demand dosage and lockout interval should be determined according to the patient’s analgesic requirements. Patients receiving a background infusion of pethidine should generally receive a smaller demand dose relative to equivalent patients utilising a demand dose only.
+- Clinical experience suggests that patients with normal renal function receiving more than 1000 mg/24hrs pethidine are at particular risk of developing pethidine associated neurotoxicity (PAN). Patients receiving over 800 mg/24hrs pethidine should usually be monitored for early signs of norpethidine toxicity. Pethidine-associated neurotoxicity is dose related, so pethidine should not be used for periods greater than 24 to 36 hours
+
+
+
Paediatric Dose:
+
+- Analgesia: Intramuscular (preferred) or subcutaneous, 0.5 to 2 mg per kg of body weight, not to exceed 100 mg, every three to four hours as needed.
+- Preoperative: Intramuscular (preferred) or subcutaneous, 1 to 2 mg per kg of body weight, not to exceed 100 mg, thirty to ninety minutes prior to anaesthesia.
+- Neonates: Excretion and metabolism of pethidine in the neonate is reduced compared with adults. Safety has not been established in neonates and due to lack of data, no dosage regimen can be recommended.
+
",,"Increased pethidine metabolite levels with aciclovir, cimetidine, ritonavir. Reduced analgesic effects with phenytoin, barbiturates. Additive sedative and/or respiratory depressive effects with alcohol, barbiturates, benzodiazepines, phenothiazines, TCAs, other CNS depressants.
","Hypersensitivity to Pethidine.
Respiratory depression, or where respiratory reserve is depleted (acute bronchial asthma, chronic airway disease, severe emphysema, severe chronic bronchitis, kyphoscoliosis).
Head injury, raised intracranial pressure (apart form introducing monitoring and diagnostic problems, hypercapnia associated with respiratory depression can itself result in elevated intracranial pressure), brain tumour.
Cardiac arrythmias, especially supraventricular tachycardias, cor pulmonale. Pethidine has a vagolytic action and may produce a significant increase in the ventricular response rate.
Concurrent use of monoamine oxidase inhibitors (MAOI’s), including selegeline, or use of MAOI’s within two weeks prior. The combination of monoamine oxidase inhibitors and pethidine has caused hypotension, hypertension, excitation, rigidity, hyperpyrexia and/or convulsions and in some cases fatalities have been reported. This combination should be avoided.
Pre-eclampsia, eclampsia.
Convulsive states such as status epilepticus, tetanus and strychnine poisoning, due to the stimulatory effects of pethidine on the spinal cord.
Diabetic acidosis where there is a danger of coma.
Acute alcoholism or delirium tremens.
Severe liver disease, incipient hepatic encephalopathy.
Patients with a low platelet count, coagulation disorders or receiving anticoagulant treatment.
Continuous Intravenous Infusion: The administration of pethidine via continuous intravenous infusion in patients with renal impairment is contraindicated.
Patient-Controlled Analgesia: The administration of pethidine via patient-controlled analgesia (PCA) in young children and adults with poor cognitive function is contraindicated. The administration of pethidine via PCA in patients with renal impairment is contraindicated.
","Central Nervous System: Lightheadedness, dizziness, sedation, sweating, bizarre feelings, disorientation, hallucinations, psychosis. Some of these effects seem to be more prominent in ambulatory patients and those not experiencing severe pain, and may be relieved by reducing the dose slightly and lying down.
Gastrointestinal: Nausea and vomiting, constipation.
","Pregnancy Category C. Opioid analgesics may cause respiratory depression in the newborn infant. These products should therefore only be used after weighing the needs of the mother during labour against the risk to the foetus. Animal reproduction studies have not been conducted with pethidine hydrochloride and safe use in pregnancy prior to labour has not been established with regard to possible adverse effects on foetal development.
Breast-feeding: Pethidine is excreted in breast milk; however, clinical data on the rate of excretion or concentration of pethidine in breast milk is not available. The clinical significance of these findings is yet to be determined. It is not recommended that pethidine be administered to nursing mothers.
","Serious or life-threatening reactions such as respiratory depression, coma, convulsions, possibly due to elevated levels of norpethidine and hypotension have been associated with the use of pethidine. Therefore the recommendations in the Warnings and Precautions sections should be carefully observed.
Pethidine should be used with caution in patients taking other CNS depressant drugs such as hypnotics and sedatives including barbiturates and benzodiazepines, phenothiazines, and other tranquillisers, anaesthetics, alcohol and antidepressants.
Patients with severe pain may tolerate very high doses of pethidine but may exhibit respiratory depression should their pain suddenly subside.
The elderly demonstrate an increased sensitivity to opioids relative to younger patients. Reduced liver function, renal function and plasma protein binding may contribute to the elevated plasma levels found in elderly subjects.
Since pethidine is metabolised in the liver and excreted via the kidneys, the possibility of accumulation of the toxic metabolic norpethidine should be considered in patients with hepatic and/or renal impairment
Reduced cardiac output may lead to reduced hepatic perfusion and diminished metabolism of pethidine leading to accumulation of pethidine with possible toxic results.
Pethidine may cause a transient rise in blood pressure and systemic vascular resistance and increased heart rate. Therefore, it is not recommended for pain relief in cardiac infarction.
Pethidine in patients with phaeochromocytoma may result in a hypertensive crisis.
In an individual physically dependent on opioids, the administration of the usual dose of an opioid antagonist will precipitate an acute withdrawal syndrome. The severity of this syndrome will depend on the degree of physical dependence and the dose of antagonist administered. The use of opioid antagonists in such individuals should be avoided if possible. If an opioid antagonist must be used to treat serious respiratory depression in the physically dependent patient, the antagonist should be administered with extreme care and only 10 to 20% of the usual initial dose administered.
Pethidine may aggravate pre-existing convulsions in patients with convulsive disorders. If dosage is escalated substantially above recommended levels because of tolerance development, convulsions may occur in individuals without a history of convulsive disorders.
In eclampsia the combination of pethidine with phenothiazines has been reported to induce recurrence of seizures rather than stopping them. Therefore, the use of pethidine in eclampsia and pre-eclampsia is not recommended.
Pethidine, while commonly used for pain relief in obstetrics, is known to pass the placenta and may cause neonatal depression, including respiratory depression. An opioid antagonist such as naloxone may be required to reverse such depression. In the neonate, pethidine is excreted and metabolised at a significantly reduced rate compared to adults.
Orthostatic hypotension has been reported in ambulatory patients administered pethidine.
Pethidine should be given with caution and the initial dose should be reduced in patients with hypothyroidism or Addison’s disease.
Pethidine should be used with caution in patients with prostatic hypertrophy or urethral stricture.
As opiate agonists may produce hyperglycaemia, this effect should be considered when diabetics require pethidine.
There are conflicting reports about the effect of pethidine on the eye. Some reports state that pethidine and its congeners produce miosis, whereas others indicate that these drugs tend to produce mydriasis or no pupillary change. Until the effects are better defined intraocular tension should be monitored in patients with glaucoma who received pethidine.
","Geriatric patients: Dose reduction to half normal adult dose is recommended in geriatric patients (over 70 years).
Liver impairment: Dosage reduction and/or increased dosage intervals are recommended.
Renal impairment: Due to the possibility of accumulation of norpethidine in patients with renal failure, caution should be exercised when pethidine is administered to these patients, especially over prolonged periods of time. Therefore, a decrease in the dose or increase in the dosing interval is recommended
","Symptoms: CNS/respiratory depression, mydriasis, bradycardia, pulmonary oedema, chronic tremor, CNS excitability, seizures.
Treatment: Symptomatic. Naloxone can be used to reverse opioid effects. Do not use naloxone for pethidine-induced seizures.
",,"Intravenous: Dilute with water for inj to a concentration of 5-10 mg/ml.
Parenteral: Moderate to severe acute pain:
+
+- IV infusion: Dilute with glucose 5% or sodium chloride 0.9% to required volume.
+- IV inj: Dilute with water for inj to a concentration of 5-10 mg/ml.
+
","Store at room temperature. Do not freeze and protect from light.
",13
+1406,Pertuzumab,pertuzumab-1406,https://medex.com.bd/attachments/neegCHDOuun9uVZ08Y4nwBNpoW4llA/pertuzumab-prescribing-information,Targeted Cancer Therapy,Breast cancer,"Pertuzumab is a HER2/neu receptor antagonist indicated for:
Use in combination with trastuzumab and docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
Use in ... Read more
Pertuzumab is a HER2/neu receptor antagonist indicated for:
Use in combination with trastuzumab and docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
Use in combination with trastuzumab and chemotherapy as:
+
+- Neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer.
+- Adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence
+
","Targeted Cancer Therapy
","Pertuzumab is a humanized monoclonal antibody designed to bind to the HER2 receptor and inhibit the ability of HER2 to interact with other HER family members (HER1, HER2, HER3, and HER4) on the surface of cancer cells. The HER signaling pathway plays a role in the formation and growth of numerous cancers, and previous clinical trials of pertuzumab in a single agent setting had suggested clinical activity-including stable disease-in heavily pretreated patients with advanced ovarian and breast cancers.
","For intravenous infusion only. Do not administer as an intravenous push or bolus.
HER2 testing: Perform using FDA-approved tests by laboratories with demonstrated proficiency.
The initial Pertuzumab dose is 840 mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by 420 mg administered as a 30 to 60 minute intravenous infusion.
MBC: Administer Pertuzumab, trastuzumab, and docetaxel by intravenous infusion every 3 weeks.
Neoadjuvant: Administer Pertuzumab, trastuzumab, and chemotherapy by intravenous infusion preoperatively every 3 weeks for 3 to 6 cycles.
Adjuvant: Administer Pertuzumab, trastuzumab, and chemotherapy by intravenous infusion postoperatively every 3 weeks for a total of 1 year (up to 18 cycles).
",,"No drug-drug interactions were observed between pertuzumab and trastuzumab, or between pertuzumab and docetaxel, paclitaxel, or carboplatin.
","Pertuzumab is contraindicated in patients with known hypersensitivity to pertuzumab or to any of its excipients
","Metastatic Breast Cancer:
+
+- The most common adverse reactions (> 30%) with Pertuzumab in combination with trastuzumab and docetaxel were diarrhea, alopecia,neutropenia, nausea, fatigue, rash, and peripheral neuropathy.
+
+Neoadjuvant Treatment of Breast Cancer:
+
+- The most common adverse reactions (> 30%) with Pertuzumab in combination with trastuzumab and docetaxel were alopecia, diarrhea, nausea, and neutropenia.
+- The most common adverse reactions (>30%) with Pertuzumab in combination with trastuzumab and docetaxel when given for 3 cycles following 3 cycles of FEC were fatigue, alopecia, diarrhea, nausea, vomiting, and neutropenia.
+- The most common adverse reactions (>30%) with Pertuzumab in combination with docetaxel, carboplatin, and trastuzumab (TCH) were fatigue, alopecia, diarrhea, nausea, vomiting, neutropenia, thrombocytopenia, and anemia.
+- The most common adverse reactions (>30%) with Pertuzumab in combination with trastuzumab and paclitaxel when given for 4 cycles following 4 cycles of ddAC were nausea, diarrhea, alopecia, fatigue, constipation and headache.
+- The most common adverse reactions (>30%) with Pertuzumab in combination with trastuzumab and docetaxel when given for 4 cycles following 4 cycles of FEC were diarrhea, nausea, alopecia, asthenia, constipation, fatigue, mucosal inflammation, vomiting, myalgia, and anemia.
+
+Adjuvant Treatment of Breast Cancer:
+
+- The most common adverse reactions (>30%) with Pertuzumab in combination with trastuzumab and chemotherapy were diarrhea, nausea, alopecia, fatigue, peripheral neuropathy and vomiting.
+
","Females and Males of Reproductive Potential: Verify the pregnancy status of females prior to initiation of Pertuzumab. There is no information regarding the presence of pertuzumab in human milk, the effects on the breastfed infant or the effects on milk production.
","Infusion-Related Reactions: Monitor for signs and symptoms. If a significant infusion-associated reaction occurs, slow or interrupt the infusion and administer appropriate medical therapies.
Hypersensitivity Reactions/Anaphylaxis: Monitor for signs and symptoms. If a severe hypersensitivity reaction/anaphylaxis occurs, discontinue the infusion immediately and administer appropriate medical therapies
",,,,,"Store vials in a refrigerator at 2°C to 8°C until time of use. Keep vial in the outer carton in order to protect from light.
",10
+305,Permethrin + Crotamiton,permethrin-crotamiton-305,,Parasiticidal preparations,Scabies,"This lotion is indicated for the treatment of scabies and pruritus.
","Local Antipruritic, Parasiticidal preparations
","Permethrin is a pyrethroid pediculocide and scabicide. It causes paralysis and death of the pest by inhibiting sodium ion influx through nerve cell membrane channels delaying repolarisation.
Crotamiton has scabicidal and antipruritic action against Sarcoptes scabei. It is an effective pediculocide as well.
","Adult: Permethrin & Crotamiton lotion is suitable for adults, children of 2 months of age and above, and the elderly. It is for external use only and should not be applied to broken skin, mucous membranes or near the eyes. Permethrin & Crotamiton lotion should be applied to skin which is clean, dry and cool. It should not be used immediately after a hot bath. Permethrin & Crotamiton lotion is intended for a single application over the whole body. Permethrin & Crotamiton lotion should be left on for at least 8 hours. Reapply the lotion to the hands if they are washed within 8 hours of treatment. The whole body should be washed thoroughly 8-12 hours after application. Adults & children over 2 years: Apply the lotion over the whole body but not the head and face. Pay particular attention to the areas between fingers and toes, under nails, wrists, armpits, external genitalia, breasts and buttocks.
The elderly: Apply the lotion over the whole body including the neck, face, ears and scalp. Pay particular attention to the areas between fingers and toes, under nails, wrists, armpits, external genitalia, breasts and buttocks. Avoid the area close to the eyes.
Children under 2 years: Children under 2 years should only be treated under medical supervision. Apply the lotion over the whole body including the neck, face, ears and scalp. Pay particular attention to the areas between fingers and toes, under nails, wrists, armpits, palms of hands and soles of feet, external genitals and buttocks. Avoid the area around the mouth where the lotion could be licked off and the area around the eyes
","Lotion should be applied to clean, dry skin. If the body is hot due to warm bath or any other reason, skin should be allowed to cool. It should be applied to the whole body excluding head. The whole body should be washed thoroughly 8-12 hours after treatment. On the next day cloths and bed sheets should be cleaned with warm water. The lotion should be applied if lotion is washed out by water. Other members of the family should use this lotion as preventive in the same way due to its highly contagious effects. The lotion should not be applied to the vicinity of mouth and areas close to eyes.
","The treatment of eczematous-like reactions with corticosteroids should be withheld prior to treatment with permethrin, as there is a risk of exacerbating the scabies infestation by reducing the immune response to the mite. The likelihood of interactions between the two treatments leading to potentiated adverse reactions or reduced efficacy is, however small.
","Combination of permethrin 5% and crotamiton 10% is contra-indicated in patients with known hypersensitivity to permethrin or crotamiton.
","Occasional reports of burning or stinging sensation which passes quickly. This is usually mild and occurs more frequently in patients with severe scabies. Transient signs and symptoms of skin irritation including rash or itching, erythema, edema and eczema. These are generally considered to be part of the natural history of scabies.
","There is no experience to judge the safety of permethrin & crotamiton in pregnancy, therefore it is not recommended during pregnancy, especially in the first three months. It is not known whether the active substance passes into breast milk. Nursing mothers should avoid applying it in the area of the nipples.
","This lotion should be kept out of the reach of children. This lotion is for external use only. Nursing staff who routinely apply this lotion may wish to wear gloves to avoid any possible irritation to the hand. Avoid contact with the eyes. The lotion can cause eye irritation. If lotion goes to the eyes, rinse with water immediately.
",,"There are no reports of overdosage of permethrin & crotamiton. Excessive application to the skin might result in local adverse reactions. In the event of accidental ingestion by a child, gastric lavage should be considered if within 2 hours of ingestion. Treatment of hypersensitivity reactions should be symptomatic.
",,,"Store in a cool place (do not store above 25° C & do not freeze) and protected from light.
",12
+876,Permethrin,permethrin-876,https://medex.com.bd/attachments/Ho2z02kL8Ck5Mqjv5JCNLcJF5Gcl1T/permethrin-prescribing-information,Parasiticidal preparations,Scabies,"Permethrin cream is indicated for the treatment of scabies and crab lice infestations (Pediculosis). Scabies can affect everyone in the family. If one is infected, all family members must be treated together.
","Parasiticidal preparations
","Permethrin cream contains Permethrin, a pyrethroid, which is a topical scabicidal agent for the treatment of infestation with Sarcoptes Scabiei (scabies). It acts on the nerve cell membrane to disrupt the sodium channel current by which the polarization of the membrane is regulated. Delayed repolarization & paralysis of the pests are the consequences of this disturbance.
Pharmacokinetics: The only approved route of administration is the topical route and there are few human data available on systemic exposure or kinetics following permethrin application to the skin. Some presystemic metabolism occurs in skin. Less than 0.5% of applied permethrin is absorbed during the first 48 hours. Absorbed permethrin is rapidly metabolized by ester hydrolysis, most likely in the liver and the products are excreted primarily in the urine.
","Recommended duration of Treatment:
+
+- Adults and children over 12 years: a full tube
+- Children aged 6-12 years: up to 1⁄2 of a tube
+- Children aged 1-5 years: up to ¼ of a tube
+- Children aged 2 months to 1 year: up to ⅛ of a tube
+- Children Less then 2 month: dose is not established
+
","Before application of Permethrin cream the skin should be clean, cool and dry. Do not have a hot shower or bath before applying.
For adults and children over 2 years: Apply the cream to the whole body from the neck down, rubbing lightly into the skin until the cream disappears. It is important to include all skin surfaces, such as between the fingers and toes, under the nails and on the soles of the feet.
For babies under 2 years: Apply to the face, neck, ears and scalp as well, only avoiding the area immediately around the eyes and mouth.
Leave cream on for at least 8 hours, before washing off. Reapply to any area that may be washed during the 8h treatment time (such as after washing the hands). If necessary, permethrin cream should be used again after 7 days as per the advice of the doctor.
","The treatment of eczemodous like reactions with corticosteroids should be withheld prior to treatment with permethrin, as there is a risk of exacerbating the scabies infestation by reducing the immune response to the mite.
","Permethrin is contraindicated in patients with known hypersensitivity to any component of pyrethroids or permethrin. Nursing staff who routinely apply permethrin may wear globes to avoid any possible irritation to the hands.
","In Scabies patients, skin discomfort, usually described as burning, stinging or tingling occurs in a few individuals soon after the cream is applied. Others transient signs and symptoms of irritation including enythema, edema, eczema, rash and puritis.
","In the absence of specific studies in pregnant women, its use in pregnancy should only follow medical advice. It is not known whether permethrin is excreted in human milk so it should not be used in nursing mothers.
","Scabies infestation is often accompanied by pruritus, edema & erythema. Treatment with permethrin may temporarily exacerbate these conditions. Patients should be advised to avoid contact with eyes during application & to flash with water immediately if the cream gets in the eyes.
",,,,,"Store in a cool, dry place, away from light & keep out of the reach of children...
",11
+176,Peritoneal Dialysis solutions,peritoneal-dialysis-solutions-176,,Peritoneal dialysis solution,Peritoneal dialysis,"This is indicated for Peritoneal Dialysis.
","Peritoneal dialysis solution
","Calcium chloride is used to prevent or treat negative calcium balance. It also regulates action potential excitation threshold to facilitate nerve and muscle performance.
Potassium chloride is a major cation of the intracellular fluid. It plays an active role in the conduction of nerve impulses in the heart, brain and skeletal muscle; contraction of cardiac skeletal and smooth muscles; maintenance of normal renal function, acid-base balance, carbohydrate metabolism and gastric secretion.
Sodium chloride is the major extracellular cation. It is important in electrolyte and fluid balance, osmotic pressure control and water distribution as it restores sodium ions. It is used as a source of electrolytes and water for hydration, treatment of metabolic acidosis, priming solution in haemodialysis and treatment of hyperosmolar diabetes. It is also used as diluents for infusion of compatible drug additives.
Sodium lactate is a sterile, nonpyrogenic solution that is used for fluid and electrolyte replenishment. It has metabolic alkalinising ability and is capable of inducing diuresis depending on the clinical condition of the patient.
Dextrose is a monosaccharide that is used as a source of calories and water for hydration. It helps to reduce loss of body protein and nitrogen. It also promotes glycogen deposition in the liver. When used with insulin, it stimulates the uptake of potassium by cells, especially in muscle tissue, thus lowering serum potassium levels.
","In case of intermittent peritoneal dialysis (IPD): 2 liters solution is instill into the abdominal cavity over a period of 1 hour then drained from the cavity.
The exchange should be continued for 8-36 hours.
",,"There are no known drug interactions and none well documented.
","Patients with excessive obesity and in pregnancy.
","During dialysis amino acids and water soluble vitamins may be lost. Fluid and electrolyte imbalance, hypovolemia, hypotension or muscle cramping may occur.
","Category - Not Classified. FDA has not yet classified the drug into a specified pregnancy category
","It is used for peritoneal dialysis purposes only.
",,,,,,9
+1468,Perindopril Arginine + Amlodipine,perindopril-arginine-amlodipine-1468,https://medex.com.bd/attachments/CIoIHHq6fitzEMmQcwN9rwyyi4tGo7/perindopril-arginine-amlodipine-prescribing-information,Combined antihypertensive preparations,Lower the blood pressure,"This combination is indicated as substitution therapy for the treatment of hypertension and/or stable coronary heart disease in patients already controlled with separate doses of perindopril and amlodipine, given concurrently at the same dose level. Treatment should not be initiated with this combination.
","Combined antihypertensive preparations
","Perindopril, a pro-drug, is hydrolyzed to perindoprilat, which inhibits ACE in humans and in animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of the inactive decapeptide, angiotensin I, to the vasoconstrictor substance angiotensin II. Angiotensin II is a potent peripheral vasoconstrictor, which stimulates aldosterone secretion by the adrenal cortex, and provides negative feedback on renin secretion. Inhibition of ACE results in decreased plasma angiotensin II, leading to decreased vasoconstriction, increased plasma renin activity and decreased aldosterone secretion. The latter results in diuresis and natriuresis and may be associated with an increase in serum potassium
Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Negative inotropic effects can be detected in vitro but such effects have not been seen in intact animals at therapeutic doses.
","perindopril arginine & amlodipine is as substitution therapy for patients already controlled with separate doses of perindopril (5 or 10 mg) and amlodipine (5 or 10 mg), given concurrently at the dose level. Treatment should not be initiated with this combination.
Food intake may reduce hepatic biotransformation of perindopril to perindoprilat. Recommended treatment is one tablet per day as a single dose, preferably to be taken in the morning and before a meal. As perindopril and amlodipine may be used for different clinical indications, dose adjustments should be based on clinical judgment and the individual patient profile.
Adjustments can be made by decreasing or increasing the dose of either perindopril and/or amlodipine using separate perindopril and/or amlodipine products within the recommended dose range until clinical stability is re-established. Consult the Product Information of the individual perindopril and/or amlodipine products being used when adjusting the dose.
In the event that down-titration is required, adjustments using amlodipine 2.5 mg or a dose of perindopril equivalent to perindopril arginine 2.5 mg, as separate products should be considered until clinical stability is re-established.
",,"Baclofen may increase the antihypertensive effect of this combination. Monitor blood pressure and renal function, and adjust the dose of this combination if necessary. Combined use of these medicines may increase the hypotensive effects of perindopril and amlodipine. Combined use with nitroglycerine and other nitrates or other vasodilators, may further reduce blood pressure and therefore should be considered with caution.
","This combination is contraindicated:
+
+- In patients with a history of previous hypersensitivity to either of the active ingredients; perindopril or amlodipine, ACE inhibitors, dihydropyridines or excipient ingredients present in this combination.
+- During pregnancy and for lactating women.
+
","The most commonly reported adverse reactions with perindopril and amlodipine given separately are: oedema, somnolence, dizziness, headache (especially at the beginning of the treatment), dysgeusia, paraesthesia, visual impairment (including diplopia), tinnitus, vertigo, palpitations, flushing, hypotension (and effects related to hypotension), dyspnoea, cough, abdominal pain, nausea, vomiting, dyspepsia, change of bowel habit, diarrhoea, constipation, pruritus, rash, exanthema, joint swelling (ankle swelling), muscle spasms, fatigue, asthenia.
","This combination should not be initiated during pregnancy and lactation. Patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with this combination should be stopped immediately, and, if appropriate, alternative treatment should be started.
","As this combination contains lactose monohydrate, patients with rare hereditary problems of galactose intolerance, glucose galactose malabsorption, or total lactase deficiency should not take This combination.
Since ACE inhibitors reduce angiotensin II formation resulting in decreased production of aldosterone, increases in serum potassium have been observed in some patients treated with ACE inhibitors including perindopril. Serum electrolytes (including sodium potassium and urea) should be measured from time to time when ACE inhibitors are given especially in combination with diuretics.
","Paediatric use: Use of this combination in children is not recommended as no data establishing safety or effectiveness in children are available.
",,,,"Store in a dry place below 25⁰C. Keep the container tightly closed and protect from light.
",11
+875,Perindopril Arginine,perindopril-arginine-875,https://medex.com.bd/attachments/tf9RHutBHvJZtb3gsg6jahrVfi8bTJ/perindopril-arginine-prescribing-information,Angiotensin-converting enzyme (ACE) inhibitors,Hypertension,"Perindopril is a long-acting ACE (Angiotensin Converting Enzyme) inhibitor and is indicated in-
+
+- Essential hypertension,
+- Stable coronary artery disease,
+- Congestive heart failure.
+
","Angiotensin-converting enzyme (ACE) inhibitors, Direct Renin Inhibitors
","Perindopril is an ACE inhibitor. It works by blocking the action of angiotensin converting enzyme (ACE). ACE produces angiotensin II, as part of the body's natural control of blood pressure. Angiotensin II causes blood vessels to constrict and narrow, which increases the pressure within the blood vessels. Perindopril blocks the action of ACE, it reduces the production of angiotensin II, thus allows the blood vessels to relax and widen. The overall effect of this is a drop in blood pressure.
","Hypertension: One Perindopril 4 tablet once daily preferably in the morning. If necessary, the dose may be increased to 8 mg after 1 month of treatment. Perindopril should be taken before food.
Stable coronary artery disease: Perindopril 4 once daily for two weeks, then increased to 8 mg once daily, depending on renal function and provided that the 4 mg dose is well tolerated. Elderly patients should receive Perindopril 2 mg once daily for one week, then Perindopril 4 once daily the next week, before increasing the dose up to 8 mg once daily, depending on renal, function. The dose should be increased only if the previous lower dose is well tolerated.
Congestive heart failure: Perindopril should be started under close medical supervision at a starting dose of 2 mg in the morning. If necessary dose may be increased to 4 mg.
Elderly patients: Start at low daily dose (4 mg or less) and titrate slowly as needed. Experience with doses exceeding 8 mg is limited.
",,"May enhance hypotensive effect with diuretics. Additive hyperkalaemic effect with K supplements, K-sparing diuretics, and other drugs (e.g. ciclosporin, heparin, indometacin). May increase serum levels and toxicity of lithium. Antihypertensive effect may be reduced by aspirin or other NSAIDs. Coadministration with NSAIDs may also increase the risk of renal impairment. Increased risk of hypoglycaemia with antidiabetic agents. Rarely, nitritoid reactions occur with concomitant use of gold (Na aurothiomalate).
","Perindopril is contraindicated in patients with a history of hypersensitivity to Perindopril. This drug is contraindicated in case of management of hypertension of Children, during Pregnancy & Lactation.
","Rare and mild: usually at the start of treatment cough, fatigue, asthenia, headache, disturbances of mood and/or sleep have been reported.
Less often: Taste impairment, epigastric discomfort, nausea, abdominal pain and rash. Reversible increase in blood urea and creatinine may be observed. Proteinuria has occurred in some patients.
Rarely: Angioneurotic edema and decrease in hemoglobin, red cells and platelets have been reported.
","Perindopril should not be used during pregnancy & lactation.
","In the following cases, Perindopril should be used with caution:
+
+- Renovascular hypertension
+- Surgery/Anesthesia
+- Renal failure: The dose should be cautiously adjusted in accordance with the creatinine clearance
+- Symptomatic hypotension is rarely seen, but is more likely in volume-depleted patients, those receiving diuretics, or with the first two doses
+- In diuretic-treated patients: stop the diuretic 3 days before starting Perindopril. A diuretic may later be given in combination if necessary; potassium-sparing diuretics are not recommended
+- Combination with neuroleptics or imipramine-type drugs may increase the hypotensive effect. Serum lithium concentrations may rise during lithium therapy
+
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+1863,Perampanel,perampanel-1863,https://medex.com.bd/attachments/RfGi5fEXUNqiLvuec82i9T4MsLrVk5/perampanel-prescribing-information,Adjunct anti-epileptic drugs,Partial seizures,"Perampanel an anti-epileptic drug is indicated for:
+
+- Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy from 4 years of age and older.
+- Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy from 12 years of age and older.
+
","Adjunct anti-epileptic drugs
","Perampanel is a non-competitive antagonist of the ionotropic α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamate receptor on post-synaptic neurons. Glutamate is the primary excitatory neurotransmitter in the central nervous system and is implicated in a number of neurological disorders caused by neuronal over excitation. The precise mechanism by which Perampanel exerts its antiepileptic effects in humans is unknown.
","Perampanel can be taken without regard to food. The dosage of Perampanel is as follows-
+
+- Starting dose: 2 mg once daily at bedtime. May increase dose based on clinical response and tolerability by increments of 2 mg once daily no more frequently than at weekly intervals.
+- Recommended maintenance dose in monotherapy or adjunctive therapy for partial-onset seizures: 8 mg to 12 mg once daily at bedtime.
+- Recommended maintenance dose in adjunctive therapy for primary generalized tonic-clonic seizures: 8 mg once daily at bedtime.
+
+
Mild and Moderate Hepatic Impairment: Maximum recommended daily dose is 6 mg (mild) and 4 mg (moderate) once daily at bedtime.
Severe Hepatic Impairment: Not recommended.
Severe Renal Impairment: Not recommended.
Elderly: Increase dose no more frequently than every 2 weeks.
",,"
+- Contraceptives: 12 mg once daily may decrease the effectiveness of hormonal contraceptives containing levonorgestrel.
+- Moderate and Strong CYP3A4 Inducers (including carbamazepine, oxcarbazepine, and phenytoin): increase the clearance of Perampanel and decrease Perampanel plasma concentrations.
+
","None.
","Perampanel may cause Serious Psychiatric and Behavioral Reactions, Suicidal Behavior and Ideation, Dizziness, Somnolence, Fatigue, Irritability, Falls, Nausea, Ataxia, Balance Disorder etc.
","Based on animal data, may cause fetal harm. There are no data on the presence of perampanel in human milk, the effects on the breastfed child, or the effects of the drug on milk production.
","
+- Suicidal Behavior and Ideation: Monitor for suicidal thoughts or Behaviour.
+- Neurologic Effects: Monitor for dizziness, gait disturbance, somnolence and fatigue.
+- Falls: Monitor for falls and injuries.
+- Drug Reaction with Eosinophilia and Systemic Symptoms/Multi-organ Hypersensitivity: Discontinue if no alternate etiology.
+- Withdrawal of Antiepileptic Drugs: In patients with epilepsy, there may be an increase in seizure frequency.
+
",,,,,"Protect from light and moisture, store below 30°C. Keep out of the reach of children.
",10
+873,Pentoxifylline,pentoxifylline-873,https://medex.com.bd/attachments/OMgs2cj0TL2LGloqjVFWZV0JNZDgHe/pentoxifylline-prescribing-information,Peripheral Vasodilator drugs: Intermittent Claudication,Peripheral vascular disease,"This is indicated in-
+
+- Peripheral arterial occlusive disease (PAOD) of arteriosclerotic or diabetic origin (e.g. with intermittent claudication and rest pain)
+- Trophic lesions (e.g. leg ulcers and gangrene)
+- Cerebral vascular diseases
+- Circulatory disturbances of the eye in conjunction with degenerative vascular disorders.
+
","Peripheral Vasodilator drugs: Intermittent Claudication
","Pentoxifylline and its metabolites improve the flow properties of blood by decreasing its viscosity. In patients with chronic peripheral arterial disease, this increases blood flow to the affected microcirculation and enhances tissue oxygenation. The precise mode of action of pentoxifylline and the sequence of events leading to clinical improvement are still to be defined. Pentoxifylline administration has been shown to produce dose-related hemorrheologic effects, lowering blood viscosity, and improving erythrocyte flexibility. Leukocyte properties of hemorrheologic importance have been modified in animal and in vitro human studies. Pentoxifylline has been shown to increase leukocyte deformability and to inhibit neutrophil adhesion and activation. Tissue oxygen levels have been shown to be significantly increased by therapeutic doses of pentoxifylline in patients with peripheral arterial disease.
","In principle, dosage is based on the type and severity of the circulatory disorders and on how the individual patient tolerates the drug. Usual dosage is 400 mg pentoxifylline 2 to 3 times daily. Tablets are to be swallowed whole during or shortly after a meal with sufficient amounts of liquid (approx. ½ glass).
",,"
+- Precautions for use: The blood-sugar-lowering effect of insulin or oral antidiabetics may be potentiated. Therefore it is recommended that patients under medication for diabetes mellitus be carefully monitored. Post-marketing cases of increased anti-coagulant activity have been reported in patients concomitantly treated with pentoxifylline and anti-vitamin K. Monitoring of anti-coagulant activity in these patients is recommended when pentoxifylline is introduced or the dose is changed.
+- Take into account: The blood-pressure-lowering efect of antihypertensive agents and other drugs with blood-pressure-lowering potential may be increased by Pentoxifylline.
+- Concomitant administration of pentoxifylline and theophylline may increase theophylline levels in some patients. Therefore, there may be an increase in and intensifcation of adverse reactions from theophylline.
+- Concomitant administration with ciprofoxacin may increase the serum concentration of pentoxifylline in some patients. Therefore, there may be an increase in and intensifcation of adverse reactions associated with co-administration.
+- Potential additive efect with platelet aggregation inhibitors: Because of the increased risk of bleeding, the concomitant administration of a platelet aggregation inhibitor (such as clopidogrel, eptifibatide, tirofiban, epoprostenol, iloprost, abciximab, anagrelide, NSAIDs other than selective COX-2 inhibitors, acetylsalicylates [ASA/LAS], ticlopidine, dipyridamole) with pentoxifylline should be undertaken with caution.
+- Concomitant administration with cimetidine may increase the plasma concentration of pentoxifylline and the active Metabolite.
+
","Pentoxifylline must not be used:
+
+- in patients with hypersensitivity to pentoxifylline, other methylxanthines or any of the excipients of Pentoxifylline.
+- in patients with massive bleeding (risk of increased bleeding).
+- in patients with extensive retinal bleeding (risk of increased bleeding).
+
","These adverse reactions have been reported in clinical trials or post-marketing-
+
+- Investigations: Transaminases increased (Transaminase elevation), Blood pressure decreased (Fall in blood pressure)
+- Cardiac disorders: Arrhythmia (Cardiac arrhythmia), Tachycardia, Angina Pectoris
+- Blood and lymphatic system disorders: Thrombocytopenia (Thrombopenia), Leucopenia/neutropenia
+- Nervous system disorders: Dizziness, headache, meningitis aseptic (Aseptic meningitis)
+- Gastrointestinal disorders: Gastrointestinal disorder (Gastrointestinal complaints), Epigastric discomfort (Gastric pressure), Abdominal distension (Fullness), Nausea, Vomiting, Diarrhoea, Constipation, Hypersalivation
+- Skin and subcutaneous tissue disorders: Pruritus, Erythema (Reddening of the skin), Urticaria, Rash
+- Vascular disorders: Hot fush (Flushes), Haemorrhage (Bleedings)
+- Immune system disorders: Anaphylactic reaction, Anaphylactoid reaction, Angioedema (Angioneurotic edema), Bronchospasm, Anaphylactic shock (shock)
+- Hepatobiliary disorders: Cholestasis (Intrahepatic cholestasis)
+- Psychiatric disorders: Agitation, Sleep disorder (Sleep disturbances)
+
","Insufficient experience has been gained concerning use in pregnancy. Therefore, it is recommended that Pentoxifylline is not used during pregnancy. Pentoxifylline passes into breast milk in minute quantities. Because insufficient experience has been gained, the physician must carefully weigh the possible risks and benefits before administering Pentoxifylline in breast-feeding women.
","At the first signs of an anaphylactic/anaphylactoid reaction, Pentoxifylline must be discontinued or the infusion be halted immediately, and a physician must be informed. Particularly careful monitoring is required:
+
+- in patients with severe cardiac arrhythmias
+- in patients with myocardial infarction
+- in hypotensive patients
+- in patients with impaired renal function (creatinine clearance below 30 ml/min)
+- in patients with severely impaired liver function
+- in patients with increased bleeding
+- in patients treated concomitantly with pentoxifylline and anti-vitamin K or platelet aggregation inhibitors
+- in patients treated concomitantly with pentoxifylline and antidiabetic agents
+- in patients treated concomitantly with pentoxifylline and ciprofoxacin
+- in patients treated concomitantly with pentoxifylline and theophylline
+
","Hepatic impairment: A dose reduction- guided by individual tolerance- is necessary in patients with severely impaired liver function.
Renal impairment: In patients with impairment of renal function (creatinine clearance below 30 mL/min) a dose reduction by approx. 30% to 50% may be necessary guided by individual tolerance.
Other: Treatment must be started at low-dose levels in hypotensive patients or patients whose circulation is unstable as well as in patients, who would be at particular risk from a reduction in blood pressure (e.g. patients with severe coronary heart disease or relevant stenoses of blood vessels supplying the brain); in such cases, the dose must only be increased gradually.
","Initial symptoms of acute overdose with pentoxifylline may be nausea, dizziness, tachycardia or a fall in blood pressure. Furthermore, signs such as fever, agitation, flush, loss of consciousness, areflexia, tonic -clonic convulsions and as a sign of gastrointestinal bleeding - coffee-ground vomiting may occur. No specific antidote is known. If ingestion has only just taken place, attempts may be made to prevent further systemic absorption of the active ingredient by primary elimination of the toxin (e.g. gastric lavage) or by delaying its absorption (e.g. activated charcoal).
",,,"Keep in a cool and dry place, away from light. Do not use later than date of expiry. Keep all medicine out of the reach of children. To be dispensed only on the prescription of a registered physician.
",12
+1861,Pentosan Polysulfate Sodium,pentosan-polysulfate-sodium-1861,https://medex.com.bd/attachments/0S2MCdlM0XWwy1kU8fsYB4vSmEgyrE/pentosan-polysulfate-sodium-prescribing-information,Other genito-urinary preparations,Interstitial cystitis,"Pentosan polysulfate sodium is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis.
","Other genito-urinary preparations
","Pentosan polysulfate is a polymer of xylose hydrogen sulfate and contains two sulfate groups per carbohydrate monomer. It binds Fibroblast growth factors (FGFs) as well as other heparin-binding growth factors. It has been shown to interact also with the heparin-binding site of FGFR-1. It inhibits the growth of SW13 adrenocortical cells transfected with FGF-4 and tumorigenicity of MCF-7 breast carcinoma cells transfected with FGF-1 or FGF-4.
","The recommended dose of Pentosan Polysulfate Sodium is 300 mg/day taken as one 100 mg capsule orally three times daily. The capsules should be taken with water at least 1 hour before meals or 2 hours after meals. Patients receiving Pentosan Polysulfate Sodium should be reassessed after 3 months. If improvement has not occurred and if limiting adverse events are not present, Pentosan Polysulfate Sodium may be continued for another 3 months. The clinical value and risks of continued treatment in patients whose pain has not improved by 6 months is not known.
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 16 years have not been established.
",,"In a study in which healthy subjects received pentosan polysulfate sodium 100 mg capsule or placebo every 8 hours for 7 days, and were titrated with warfarin to an INR of 1.4 to 1.8, the pharmacokinetic parameters of R-warfarin and S-warfarin were similar in the absence and presence of pentosan polysulfate sodium. INR for warfarin + placebo and warfarin + pentosan polysulfate sodium were comparable.
","Pentosan Polysulfate Sodium is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients.
","Alopecia (4%), diarrhea (4%), nausea (4%), headache (3%), rash (3%), dyspepsia (2%), abdominal pain (2%), liver function abnormalities (1%), dizziness (1%).
","Pregnancy: Reproduction studies have been performed in mice and rats with intravenous daily doses of 15 mg/kg, and in rabbits with 7.5 mg/kg. These doses are 0.42 and 0.14 times the daily oral human doses of Pentosan Polysulfate Sodium when normalized to body surface area. These studies did not reveal evidence of impaired fertility or harm to the fetus from Pentosan Polysulfate Sodium. Direct in vitro bathing of cultured mouse embryos with pentosan polysulfate sodium (PPS) at a concentration of 1 mg/mL may cause reversible limb bud abnormalities. Adequate and well-controlled studies have not been performed in pregnant women. Because animal studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Pentosan Polysulfate Sodium is administered to a nursing woman.
","Pentosan Polysulfate Sodium is a weak anticoagulant (1/15 the activity of heparin). At a daily dose of 300 mg (n=128), rectal hemorrhage was reported as an adverse event in 6.3% of patients. Bleeding complications of ecchymosis, epistaxis, and gum hemorrhage have been reported. Patients undergoing invasive procedures or having signs/symptoms of underlying coagulopathy or other increased risk of bleeding (due to other therapies such as coumarin anticoagulants, heparin, t-PA, streptokinase, high dose aspirin, or nonsteroidal anti inflammatory drugs) should be evaluated for hemorrhage. Patients with diseases such as aneurysms, thrombocytopenia, hemophilia, gastrointestinal ulcerations, polyps, or diverticula should be carefully evaluated before starting Pentosan Polysulfate Sodium. A similar product that was given subcutaneously, sublingually, or intramuscularly (and not initially metabolized by the liver) is associated with delayed immunoallergic thrombocytopenia with symptoms of thrombosis and hemorrhage. Caution should be exercised when using Pentosan Polysulfate Sodium in patients who have a history of heparin induced thrombocytopenia. Alopecia is associated with pentosan polysulfate and with heparin products. In clinical trials of Pentosan Polysulfate Sodium, alopecia began within the first 4 weeks of treatment. Ninety-seven percent (97%) of the cases of alopecia reported were alopecia areata, limited to a single area on the scalp.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+872,Pentazocine Hydrochloride,pentazocine-hydrochloride-872,,Opioid analgesics,Pain,"For the relief of moderate to severe pain. Pentazocine may also be used for preoperativeor preanesthetic medication and as a supplement to surgical anesthesia.
","Opioid analgesics
","Pentazocine is a benzomorphan derivative with mixed opioid agonist and antagonist actions. It alters perception of and response to pain and produces generalised CNS depression by binding to opiate receptors in the CNS and acting as a partial agonist/antagonist.
","Tablet:
+Adults: The usual initial adult dose is 1 tablet every three or four hours. This may be increased to 2 tablets when needed. Total daily dosage should not exceed 12 tablets.
+Injection:
+Adults, Excluding Patients in Labor: The recommended single parenteral dose is 30 mg by intramuscular, subcutaneous, or intravenous route. This may be repeated every 3 to 4 hours. Doses in excess of 30 mg intravenously or 60 mg intramuscularly or subcutaneously are not recommended. Total daily dosage should not exceed 360 mg. Elderly patients may be more sensitive to the analgesic effects of Pentazocine than younger patients. Elderly patients generally should be started on low doses of Pentazocine and observed closely.
The subcutaneous route of administration should be used only when necessary because of possible severe tissue damage at injection sites. When frequent injections are needed, the drug should be administered intramuscularly. In addition, constant rotation of injection sites (e.g., the upper outer quadrants of the buttocks, mid-lateral aspects of the thighs, and the deltoid areas) is essential.
Patients in Labor: A single, intramuscular 30 mg dose has been most commonly administered. An intravenous 20 mg dose has given adequate pain relief to some patients in labor when contractions become regular, and this dose may be given two or three times at two- to three-hour intervals, as needed.
Pediatric Patients Excluding Patients Less Than One-Year-Old: The recommended single parenteral dose as premedication for sedation is 0.5 mg/kg by intramuscular route.",,"Depressant affects potentiated by alcohol, CNS depressants; concurrent use with fluoxetine may lead to diaphoresis, ataxia flushing and tremor associated with serotonin syndrome.
","Pentazocine should not be administered to patients who are hypersensitive to it.
","Physical dependence; sedation, dizziness, euphoria, lightheadedness, alterations of mood; respiratory depression; visual hallucinations, disorientation, confusion; hypertension, tachycardia, circulatory depression; shock; hypotension; nausea, vomiting, constipation; seizures, diaphoresis; rash; blood dyscrasias; local tissue damages (SC), muscle fibrosis (IM).
","Safe use of Pentazocine during pregnancy (other than labor) has not been established. Animal reproduction studies have not demonstrated teratogenic or embryotoxic effects. However, Pentazocine should be administered to pregnant patients (other than labor) only when, in the judgment of the physician, the potential benefits outweigh the possible hazards. Patients receiving Pentazocine during labor have experienced no adverse effects other than those that occur with commonly used analgesics. Pentazocine should be used with caution in women delivering premature infants.
","May precipitate withdrawal in narcotic addicts. Impaired respiratory, renal and hepatic function; morbidly obese patients; thyroid dysfunction; prostatic hyperplasia or urinary stricture; biliary tract impairment; adrenal insufficiency (including Addison's disease); abdominal conditions. Elderly or debilitated patients; seizure-prone patients; children and infants (safety and efficacy not established in less than 1 yr); lactation. May impair ability to drive or operate machinery. Administer IM rather than SC (when frequent inj are needed) and inj sites should be varied.
","Pediatric Use: The safety and efficacy of Pentazocine as preoperative or preanesthetic medication have been established in pediatric patients 1 to 16 years of age. Use of Pentazocine in these age groups is supported by evidence from adequate and controlled studies in adults with additional data from published controlled trials in pediatric patients. The safety and efficacy of Pentazocine as a premedication for sedation have not been established in pediatric patients less than one year old. Information on the safety profile of Pentazocine as a postoperative analgesic in children less than 16 years is limited.
Geriatric Use: Elderly patients may be more sensitive to the analgesic effects of Pentazocine than younger patients. Clinical data indicate that differences in various pharmacokinetic parameters of Pentazocine may exist between elderly and younger patients. Sedating drugs may cause confusion and oversedation in the elderly; elderly patients generally should be started on low doses of Pentazocine and observed closely.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
",,,,,10
+871,Pemirolast Potassium,pemirolast-potassium-871,,Ophthalmic Non-Steroid drugs,Conjunctivitis,"Pemirolast ophthalmic solution is indicated for the prevention of itching of the eye due to allergic conjunctivitis.
","Ophthalmic Non-Steroid drugs
","Pemirolast binds to the histamine H1 receptor. This blocks the action of endogenous histamine, which subsequently leads to temporary relief of the negative symptoms brought on by histamine. Pemirolast has also been observed to inhibit antigen-stimulated calcium ion influx into mast cells through the blockage of calcium channels. Pemirolast inhibits the chemotaxis of eosinophils into ocular tissue, and prevents inflammatory mediator release from human eosinophils.
","Adult: 1 to 2 drops in each affected eye four times daily.
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 3 years have not been established.
",,,"Pemirolast ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients of this product.
","Burning of eye, dry eye, ocular discomfort, non ocular allergy, sinusitis, headache and sneezing or nasal congestion.
","Pregnancy: There are no adequate and well-controlled studies in pregnant women. Pemirolast ophthalmic solution should be used during pregnancy only if the benefit outweighs the risk.
Lactation: It is not known whether Pemirolast Potassium is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Pemirolast ophthalmic solution is administered to a nursing woman.
","To prevent contaminating the dropper tip and solution, do not touch the eyelids or surrounding areas with the dropper tip. Keep the bottle tightly closed when not in use Patients should be advised not to wear contact lens if their eye is red Pemirolast should not be used to treat contact lens related irritation Patients should wait 10 minutes after applying Pemirolast before they insert contact lenses
",,,,,"Store at 15-25° C. Keep out of reach of children. Do not use more than 4 weeks after opening
",9
+870,Pemetrexed,pemetrexed-870,https://medex.com.bd/attachments/njvVw8LhR1Zs8OWALS3we3qc5VRpSv/pemetrexed-prescribing-information,Cytotoxic Chemotherapy,Non-small cell lung cancer,"Pemetrexed is indicated for:
+
+- Initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC) in combination with cisplatin.
+- Maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as a single agent.
... Read more
Pemetrexed is indicated for:
+
+- Initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC) in combination with cisplatin.
+- Maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as a single agent.
+- Treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy, as a single agent.
+
","Cytotoxic Chemotherapy
","Pemetrexed is a thymidylate synthase inhibitor. It works by inhibiting thymidylate synthase, dihydrofolate reductase, glycinamide ribonucleotide formyltransferase and aminoimidazole carboxamide ribonucleotide formyltransferase, the enzymes involved in folate metabolism and DNA synthesis, thus inhibiting purine and thymidine nucleotide and protein synthesis.
","Recommended Dosage And Schedule For Non-Squamous NSCLC:
+
+- The recommended dose of Pemetrexed in combination with cisplatin for initial treatment of NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes administered prior to cisplatin on Day 1 of each 21-day cycle for up to six cycles in the absence of disease progression or unacceptable toxicity.
+- The recommended dose of Pemetrexed for maintenance treatment of NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity after four cycles of platinum-based first-line chemotherapy.
+- The recommended dose of Pemetrexed for treatment of recurrent NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
+
+
Recommended Dosage And Schedule For Mesothelioma: The recommended dose of Pemetrexed, administered in combination with cisplatin, in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
",,"High doses of NSAIDs and aspirin may reduce the elimination of pemetrexed; avoid usage 2 days (5 days for longer-acting NSAIDs) before, during and 2 days after treatment with pemetrexed in patients with impaired renal function. Additive GI side effects when used with SSRIs, acetylcholinesterase inhibitors, aripiprazole or ziprasidone. Additive sedation when used with psychotropics. Concurrent use with nephrotoxic drugs (e.g. aminoglycosides, loop diuretics, platinum compounds and ciclosporin) may decrease pemetrexed clearance, thus increasing the risk of toxicity. Clearance may be reduced when used with drugs that are cleared by tubular secretion e.g. probenecid and penicillin.
","Pemetrexed is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed
","The following adverse reactions are discussed in greater detail in other sections of the labeling:
+
+- Myelosuppression
+- Renal failure
+- Bullous and exfoliative skin toxicity
+- Interstitial pneumonitis
+- Radiation recall
+
","Pregnancy Category D. There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Lactation: Advise women not to breastfeed during treatment with Pemetrexed and for 1 week after the final dose
","Monitor CBC. Premedication with folate and vitamin B12 are recommended as prophylaxis against haematological and GI toxicity during treatment. Pre-treatment with a corticosteroid also reduces the incidence and severity of skin reactions. Caution when used in renal or hepatic impairment. Not recommended for use in pregnancy and lactation.
","Renal Impairment: Pemetrexed dosing recommendations are provided for patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater. There is no recommended dose for patients whose creatinine clearance is less than 45 mL/min
Pediatric Use: The safety and effectiveness of Pemetrexed in pediatric patients have not been established.
Geriatric Use: Of the 3,946 patients enrolled in clinical studies of Pemetrexed, 34% were 65 and over and 4% were 75 and over. No overall differences in effectiveness were observed between these patients and younger patients. The incidences of Grade 3-4 anemia, fatigue, thrombocytopenia, hypertension, and neutropenia were higher in patients 65 years of age and older as compared to younger patients: in at least one of five randomized clinical trials.
","No drugs are approved for the treatment of Pemetrexed overdose. Based on animal studies, administration of leucovorin may mitigate the toxicities of Pemetrexed overdosage. It is not known whether pemetrexed is dialyzable.
",,,"Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)
",12
+1808,Pembrolizumab,pembrolizumab-1808,https://medex.com.bd/attachments/xMQVKX8gKrAK8nLAk2nSvEyduJ6UTV/pembrolizumab-prescribing-information,Immunosuppressant,Melanoma,"Pembrolizumab is a programmed death receptor-1 (PD-1)-blocking antibody indicated:
Melanoma:
+
+- for the treatment of patients with unresectable or metastatic melanoma.
+- for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
... Read more
Pembrolizumab is a programmed death receptor-1 (PD-1)-blocking antibody indicated:
Melanoma:
+
+- for the treatment of patients with unresectable or metastatic melanoma.
+- for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
+
+
Non-Small Cell Lung Cancer (NSCLC):
+
+- in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
+- in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC.
+- as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is: stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.
+- as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Pembrolizumab.
+
+
Small Cell Lung Cancer (SCLC): for the treatment of patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
Head and Neck Squamous Cell Cancer (HNSCC):
+
+- in combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC.
+- as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test.
+- as a single agent for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
+
+
Classical Hodgkin Lymphoma (cHL): for the treatment of adult and pediatric patients with refractory cHL, or who have relapsed after 3 or more prior lines of therapy.
Primary Mediastinal Large B-Cell Lymphoma (PMBCL): for the treatment of adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therapy.
Urothelial Carcinoma:
+
+- for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [Combined Positive Score (CPS) ≥10] as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.
+- for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
+- for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
+
+
Microsatellite Instability-High Cancer: for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient. solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
Gastric Cancer: for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, with disease progression on or after 2 or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.
Esophageal Cancer: for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 [Combined Positive Score (CPS) ≥10] as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.
Cervical Cancer: for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test.
Hepatocellular Carcinoma (HCC): for the treatment of patients with HCC who have been previously treated with sorafenib.
Merkel Cell Carcinoma (MCC): for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.
Renal Cell Carcinoma (RCC): in combination with axitinib, for the first-line treatment of patients with advanced RCC.
Endometrial Carcinoma: in combination with lenvatinib, for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation.
","Immunological Chemotherapy, Immunosuppressant
","Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth.
","
+- Melanoma: 200 mg every 3 weeks
+- NSCLC: 200 mg every 3 weeks
+- SCLC: 200 mg every 3 weeks
+- HNSCC: 200 mg every 3 weeks
+- cHL or PMBCL: 200 mg every 3 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics
+- Urothelial Carcinoma: 200 mg every 3 weeks
+- MSI-H Cancer: 200 mg every 3 weeks for adults and 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics
+- Gastric Cancer: 200 mg every 3 weeks
+- Esophageal Cancer: 200 mg every 3 weeks
+- Cervical Cancer: 200 mg every 3 weeks
+- HCC: 200 mg every 3 weeks
+- MCC: 200 mg every 3 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics
+- RCC: 200 mg every 3 weeks with axitinib 5 mg orally twice daily
+- Endometrial Carcinoma: 200 mg every 3 weeks with lenvatinib 20 mg orally once daily for tumors that are not MSI-H or dMMR.
+
+Administer Pembrolizumab as an intravenous infusion over 30 minutes.
",,,"None.
","Most common adverse reactions (reported in ≥20% of patients) were:
Pembrolizumab as a single agent: fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, and abdominal pain.
Pembrolizumab in combination with chemotherapy: fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, pyrexia, alopecia, peripheral neuropathy, mucosal inflammation, and stomatitis.
Pembrolizumab in combination with axitinib: diarrhea, fatigue/asthenia, hypertension, hepatotoxicity, hypothyroidism, decreased appetite, palmar-plantar erythrodysesthesia, nausea, stomatitis/mucosal inflammation, dysphonia, rash, cough, and constipation.
Pembrolizumab in combination with lenvatinib: fatigue, hypertension, musculoskeletal pain, diarrhea, decreased appetite, hypothyroidism, nausea, stomatitis, vomiting, decreased weight, abdominal pain, headache, constipation, urinary tract infection, dysphonia, hemorrhagic events, hypomagnesemia, palmar-plantar erythrodysesthesia, dyspnea, cough, and rash.
","Based on its mechanism of action, Pembrolizumab can cause fetal harm when administered to a pregnant woman. There are no available human data informing the risk of embryo-fetal toxicity. There are no data on the presence of pembrolizumab in either animal or human milk or its effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with Pembrolizumab and for 4 months after the final dose.
","Immune-mediated pneumonitis: Withhold for moderate, and permanently discontinue for severe, life-threatening or recurrent moderate pneumonitis.
Immune-mediated colitis: Withhold for moderate or severe, and permanently discontinue for life-threatening colitis.
Immune-mediated hepatitis (Pembrolizumab) and hepatotoxicity (Pembrolizumab in combination with axitinib): Monitor for changes in hepatic function. Based on severity of liver enzyme elevations, withhold or discontinue Pembrolizumab, axitinib, or Pembrolizumab and axitinib. Consider corticosteroid therapy.
Immune-mediated endocrinopathies:
+
+- Adrenal insufficiency: Withhold for moderate and withhold or permanently discontinue for severe or life-threatening adrenal insufficiency.
+- Hypophysitis: Withhold for moderate and withhold or permanently discontinue for severe or life-threatening hypophysitis.
+- Thyroid disorders: Monitor for changes in thyroid function. Withhold or permanently discontinue for severe or life-threatening hyperthyroidism.
+- Type 1 diabetes mellitus: Monitor for hyperglycemia. Withhold Pembrolizumab in cases of severe hyperglycemia.
+
+
Immune-mediated nephritis: Monitor for changes in renal function. Withhold for moderate, and permanently discontinue for severe or life-threatening nephritis.
Immune-mediated skin adverse reactions including, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN): Withhold for severe and permanently discontinue for life-threatening skin reactions.
Other immune-mediated adverse reactions: In organ transplant recipients, consider the benefit of treatment with Pembrolizumab versus the risk of possible organ rejection.
Infusion-related reactions: Stop infusion and permanently discontinue Pembrolizumab for severe or life-threatening infusion reactions.
Complications of allogeneic HSCT: Allogeneic HSCT after treatment with Pembrolizumab: Monitor for hepatic veno-occlusive disease, grade 3-4 acute GVHD including hyperacute GVHD, steroid-requiring febrile syndrome, and other immune-mediated adverse reactions. Transplant-related mortality has occurred. Allogeneic HSCT prior to treatment with Pembrolizumab: In patients with a history of allogeneic HSCT, consider the benefit of treatment with Pembrolizumab versus the risk of GVHD.
Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.
Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective method of contraception.
","The safety and effectiveness of Pembrolizumab in pediatric patients have not been established. No overall differences in safety or effectiveness were observed between elderly patients and younger patients.
",,,,"Store vials under refrigeration at 2°C to 8°C.
",10
+1665,Pegylated Erythropoietin,pegylated-erythropoietin-1665,,Drugs for Haemolytic Hypoplastic & Renal Anemia,"Anemia, vitamin & mineral deficiency","Pegylated erythropoietin is indicated for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis and patients, not on dialysis.
It is not indicated for use:
+
+- In the treatment of anemia due to cancer chemotherapy.
+- As a substitute for RBC transfusions in patients who require immediate correction of anemia.
+
","Drugs for Haemolytic Hypoplastic & Renal Anemia
","Pegylated erythropoietin is an erythropoietin receptor activator with greater activity in vivo as well as increased half-life, in contrast to erythropoietin. It differs from erythropoietin through the integration of an amide bond between the N-terminal amino group or the ε-amino group of any lysine present in erythropoietin, predominantly Lys52 and Lys45 and Pegylated Erythropoietin (PEG).
","Initiate Pegylated Erythropoietin treatment when the hemoglobin level is less than 10 g/dL. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Pegylated Erythropoietin.
If the hemoglobin rises rapidly (e.g, more than 1 g/dL in any 2 week period), reduce the dose of Pegylated Erythropoietin by 25% or more as needed to reduce rapid responses. And for patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g /dL after 4 weeks of therapy, increase the dose by 25%
For patients who do not respond adequately over a 12 week escalation period, increasing the Pegylated Erythropoietin dose further is unlikely to improve response and may increase risks
For patients with CKD on dialysis:
+
+- The recommended starting dose of Pegylated Erythropoietin for the treatment of anemia in adult CKD patients who are not currently treated with an ESA is 0.6 mcg/kg body weight administered as a single IV or SC injection once every two weeks.
+- Once the hemoglobin has been stabilized, it may be administered once monthly using a dose that is twice that of the every two-week dose and subsequently titrated as necessary.
+
+For patients with CKD not on dialysis:
+
+- The recommended starting dose of Pegylated erythropoietin for the treatment of anemia in adult CKD patients who are not currently treated with an ESA is 0.6 mcg/kg body weight administered as a single IV or SC injection once every two weeks.
+- Once the hemoglobin has been stabilized, it may be administered once monthly using a dose that is twice that of the every two-week dose and subsequently titrated as necessary.
+- Conversion from another ESA to Pegylated erythropoietin: It can be administered once every two weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA.
+
",,,,"
+- Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism
+- Increased mortality and/or tumor progression in patients with cancer
+- Hypertension
+- Seizures
+- Pure red cell aplasia
+- Serious allergic reactions
+
","Pregnancy Category C. It is not known whether it is excreted into human breast milk. Because many drugs are excreted in human milk, caution should be exercised when it is administered to a nursing woman.
Evaluation of Iron stores: Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 mcg/L or with transferrin saturation below 20%. To ensure effective erythropoiesis, iron status has to be evaluated for all patients prior to and during treatment.
","
+- Using ESA to target a hemoglobin level of >11 g/dL increase the rate of serious adverse cardiovascular reactions. It should be used with caution in patients with co-existant cardiovascular disease, stroke, seizure etc.
+- Control hypertension prior to initiating of and during treatment with it
+- Monitoring of patients for the change in seizure frequency or premonitory symptoms.
+- If severe anemia and low reticulocyte count develop during the treatment, withhold it and evaluate patients for neutralizing antibodies to erythropoietin
+
",,"Pegylated Erythropoietin overdosage can elevate hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Pegylated Erythropoietin dosage and/or with phlebotomy. Cases of severe hypertension have been observed following overdose with ESAs.
",,,"Store at 2°C to 8°C at the refrigerator. Protect from light. Do not shake the syringe. Keep out of the reach of children.
",9
+868,Peginterferon alfa-2a [Pegylated Interferon alfa-2a],peginterferon-alfa-2a-pegylated-interferon-alfa-2a-868,https://medex.com.bd/attachments/DIKUfrJlgS6rPTfLZWL6HUSqCAjqEt/peginterferon-alfa-2a-pegylated-interferon-alfa-2a-prescribing-information,Hepatic viral infections (Hepatitis B),Chronic myelogenous leukaemia,"Chronic Hepatitis C: Peginterferon alfa-2a alone or in combination with Ribavirin, is indicated for the treatment of adults with chronic hepatitis C (CHC) virus infection who have compensated liver disease and have not been previously treated with interferon alpha.
Chronic Hepatitis B ... Read more
Chronic Hepatitis C: Peginterferon alfa-2a alone or in combination with Ribavirin, is indicated for the treatment of adults with chronic hepatitis C (CHC) virus infection who have compensated liver disease and have not been previously treated with interferon alpha.
Chronic Hepatitis B: Peginterferon alfa-2a is indicated for the treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation.
","Hepatic viral infections (Hepatitis B), Hepatic viral infections (Hepatitis C)
","Peginterferon alfa-2a are interferon proteins bound to polyethylene glycol (PEG) molecules resulting in higher and more prolonged serum interferon concentrations. It has antiviral, antiproliferative and immune-regulating activity. Interferons are activated when it interacts with cells through high affinity cell surface receptors. The effects of this activation include the induction of gene transcription, inhibition of cellular growth, alteration of cellular differentiation, interference with oncogene expression, alteration of cell surface antigen expression, increase in phagocytic activity of macrophages and augmentation of cytotoxicity of lymphocytes for target cells.
","Chronic hepatitis C: The recommended dose of Peg interferon is 180 mcg once weekly for 48 weeks by subcutaneous administration on abdomen or thigh
Chronic hepatitis B: The recommended dose of Peg interferon is 180 mcg once weekly for 48 weeks by subcutaneous administration on abdomen or thigh
Hepatitis C Genotype 1 & 4:
+
+- Pegylated Interferon alfa-2a Monotherapy: 180 mcg once weekly for 48 weeks
+- Pegylated Interferon alfa-2a dual therapy: 180 mcg once weekly for 48 weeks; Celbarin: <75 kg= (400+0+600) mg, >75 kg= (600+0+600) mg.
+
+Hepatitis C Genotype 2 & 3:
+
+- Pegylated Interferon alfa-2a Monotherapy: 180 mcg once weekly for 48 weeks
+- Pegylated Interferon alfa-2a dual therapy: 180 mcg once weekly for 24 weeks; Celbarin: (400+0+400) mg.
+
",,"
+- Drugs metabolized by CYP1A2: monitor for increased serum levels of theophylline and adjust dose accordingly
+- Methadone: monitor for signs and symptoms of methadone toxicity
+- Nucleoside analogues: closely monitor for toxicities and dose reduce or discontinue Peginterferon alfa 2a/ Ribavirin or both should event worsen
+- Zidovudine: monitor for worsening neutropenia and/or anemia with peginterferon alfa/rifavirin
+- Azathioprine.
+
","
+- Hypersensitivity to any component of the product
+- Autoimmune hepatitis
+- Hepatic decompensation in cirrhotic patients before or during treatment
+- Hepatic decompensation with Child-Pugh score greater than or equal to 6 in cirrhotic CHC patients co infected with HIV during or before treatment
+- Neonate or infants.
+
","
+- Depression, suicide, relapse of drug abuse and bacterial infection
+- Flu like symptoms: Fatigue, pyrexia,
+- Gastrointestinal: Nausea/Vomiting, diarrhea, abdominal pain
+- Metabolic and Nutritional: Anorexia
+- Musculoskeletal: Myalgia, arthralgia
+- Neurological: Headache, dizziness, insomnia
+- Psychiatric reactions: Irritability, anxiety
+- Injection site reaction, skin problems, hair loss
+- Endocrine: Hypothyroidism
+
","Pregnancy Category C: Peginterferon alfa-2a monotherapy. There are no adequate and well controlled trial on pregnant women & developing fetus due to teratogenic effects. Peginterferon alfa-2a is recommended for use in women of childbearing potential only when they are using effective contraception during therapy.
Pregnancy Category X. It is not known whether peginterferon or ribavirin or its components are excreted in human milk. Because of the potential for adverse reactions from the drugs in nursing infants, a decision must be made whether to discontinue nursing or discontinue peginterferon and ribavirin treatment.
","
+- Patients who have failed alpha interferon treatment with or without ribavirin
+- Liver or other organ transplant recipients
+- Hepatitis B patients coinfected with HCV or HIV
+- Hepatitis C patients coinfected with HBV or coinfected with HIV with a CD4+ cell count < 100 cells/µL
+- Caution should be exercised in initiating treatment in any patient with baseline risk of severe anemia
+
","Hepatic Impairment:
Chronic hepatitis C: Alanine transaminase (ALT) progressively rising above baseline: Decrease dose to 135 mcg/wk. If ALT continues to rise or is accompanied by increased bilirubin or hepatic decompensation, discontinue immediately.
Chronic hepatitis B: Alanine transaminase (ALT) >5 times the upper limits of normal: Monitor LFTs more frequently; consider 135 mcg/wk or temporarily discontinuing (may resume after ALT flare subsides). ALT >10 times the upper limits of normal: Consider discontinuing.
Dose modifications:
For moderate-to-severe adverse reactions: Initially, 135 mcg/wk or in some cases, 90 mcg/wk. Haematologic parameters: ANC <750/mm3: 135 mcg/wk; ANC <500/mm3: Discontinue therapy until >1000/mm3, then restart at 90 mcg/wk; monitor ANC. Platelet count: <50,000/mm3: 90 mcg/wk; <25,000/mm3: Discontinue therapy. Depression: Moderate: Decrease to 90-135 mcg once/wk; evaluate once wkly, if symptoms improve and remain stable for 4 wk, continue reduced dosing or return to normal dose; Severe: Discontinue treatment permanently. Administer in the abdomen or thigh.
Renal Impairment:
CrCl <50: Use caution; monitor for toxicity .
","There are limited experiences of overdose. There were no serious reactions attributed to overdose. There is no specific antidote. Dialysis is not effective.
",,,"Store in refrigerator at 2-8° C; do not freeze or shake. Protect from light.
",12
+867,Pegfilgrastim [Pegylated Filgrastim],pegfilgrastim-pegylated-filgrastim-867,https://medex.com.bd/attachments/yhqK9A48KazAkL5B6MqcqKr2rg9QHq/pegfilgrastim-pegylated-filgrastim-prescribing-information,Hematopoietic drug,Neutropenia,"Pegfilgrastim is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
","Hematopoietic drug
","Pegfilgrastim, a Granulocyte Colony-Stimulating Factor (G-CSF) is a pegylated glycoprotein that regulates the production and release of functional neutrophils from bone marrow. Pegfilgrastim is a covalent conjugate of recombinant methionyl human G-CSF (Filgrastim) and monomethoxy polyethylene glycol. Filgrastim is a water soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD) and a 20 kD monomethoxy polyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of filgrastim. The average molecular weight of pegfilgrastim is approximately 39 kD.
","The recommended dosage of Pegfilgrastim is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle in adults. Do not administer Pegfilgrastim between 14 days before and 24 hours after administration of cytotoxic chemotherapy. Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer Pegfilgrastim if discoloration or particulates are observed.
NOTE: The needle cover on the single-use pre-filled syringe contains dry natural rubber (latex); persons with latex allergies should not administer this product.
",,"No formal drug interaction studies between Pegfilgrastim and other drugs have been performed. Increased hematopoietic activity of the bone marrow in response to growth factor therapy may result in transiently positive bone-imaging changes. Consider these findings when interpreting bone-imaging results. This medicinal product must not be mixed with other medicinal product, particularly sodium chloride solutions.
","Do not administer Pegfilgrastim to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.
","Splenic Rupture: Splenic rupture, including fatal cases, can occur following the administration of Pegfilgrastim. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Pegfilgrastim.
Acute Respiratory Distress Syndrome: Acute Respiratory Distress Syndrome (ARDS) can occur in patients receiving Pegfilgrastim. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Pegfilgrastim for ARDS. Discontinue Pegfilgrastim in patients with ARDS.
Serious Allergic Reactions: Serious allergic reactions, including anaphylaxis can occur in patients receiving Pegfilgrastim. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Pegfilgrastim in patients: with serious allergic reactions. Do not administer Pegfilgrastim to patients with a history of serious allergic reactions to Pegfilgrastim or Filgrastim.
Patients with Sickle Cell Disorders: Severe sickle cell crises can occur in patients with sickle cell disorders receiving Pegfilgrastim. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving Filgrastim, the parent compound of Pegfilgrastim.
","Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Pegfilgrastim was embryotoxic and increased pregnancy loss in pregnant rabbits that received cumulative doses approximately 4 times the recommended human dose (based on body surface area). Signs of maternal toxicity occurred at these doses. Pegfilgrastim should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether Pegfilgrastim is secreted in human milk. Other recombinant G-CSF products are poorly secreted in breast milk and G-CSF is not orally absorbed by neonates. Caution should be exercised when administered to a nursing woman.
","
+- Fatal splenic rupture can occur. Evaluate for splenomegaly or splenic rupture in patients with left upper abdominal or shoulder pain.
+- Acute Respiratory Distress Syndrome (ARDS) can occur. Evaluate for ARDS in patients who develop fever, lung infiltrates, or respiratory distress. Discontinue Pegfilgrastim in patients with ARDS.
+- Serious allergic reactions, including anaphylaxis, can occur. Permanently discontinue Pegfilgrastim in patients with serious allergic reactions.
+
","Pediatric Use: Safety and effectiveness of Pegfilgrastim in pediatric patients have not been established.
Geriatric Use: Of the 932 patients with cancer who received Pegfilgrastim in clinical studies, 139 (15%) were age 65 and over, and 18 (2%) were age 75 and over. No overall differences in safety or effectiveness were observed between patients age 65 and older and younger patients.
Renal Impairment: In a study of 30 subjects with varying degrees of renal dysfunction, including end stage renal disease, renal dysfunction had no effect on the pharmacokinetics of Pegfilgrastim. Therefore, Pegfilgrastim dose adjustment in patients with renal dysfunction is not necessary.
","The maximum amount of Pegfilgrastim that can be safely administered in single or multiple doses has not been determined. Single subcutaneous doses of 300 mcg/kg have been administered to 8 healthy volunteers and 3 patients with non-small cell lung cancer without serious adverse effects. These patients experienced a mean maximum Absolute Neutrophil Count (ANC) of 55x109/L, with a corresponding mean maximum WBC of 67x109/L. The absolute maximum ANC observed was 96x109/L with a corresponding absolute maximum WBC observed of 120x109/L.
",,,"Pegfilgrastim should be stored in a refrigerator at 2-8°C. Do not freeze. Do not shake. Keep away from light
",12
+1235,Podophyllotoxin,podophyllotoxin-1235,https://medex.com.bd/attachments/kP2ATNViAFOt4TIcpTmjygHcflvZ87/podophyllotoxin-prescribing-information,Anti neoplastic preparations,Warts,"For the removal of external genital warts located on the penis and vulva
","Anti neoplastic preparations
","Podophyllotoxin has an antimitotic action and is used mainly as a topical treatment for anogenital warts.
","Apply twice daily, morning and evening (every 12 hours) for three consecutive days followed by four days without treatment. The use of 0.5% Podophyllotoxin Topical Solution is twice a day for three days constitutes a treatment cycle. Treatment cycles should be repeated up to four times until there is no visible wart tissue.
",,,"Hypersensitivity; pregnancy; lactation; child.
","Irritating to the eyes and mucous membranes; GI disturbances; thrombocytopenia, leucopenia; renal failure; hepatotoxicity; CNS effects; EEG changes; peripheral and autonomic neuropathies; local reactions
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Avoid excessive application. Avoid contact with eyes and inflamed skin. Not to be used on cervical or urethral warts.
",,,,,,8
+895,Pizotifen,pizotifen-895,https://medex.com.bd/attachments/vNPUO4DNxFtRZKSB2RUpLERDbpvgT6/pizotifen-prescribing-information,Other drugs for migraine,Migraine,"Pizotifen is indicated as prophylactic treatment of vascular headache of migraine type such as classical migraine, common migraine and cluster headache. It is not effective in relieving migraine attacks once in progress.
","Anti-histamine Preparations, Other drugs for migraine
","Pizotifen works by inhibiting the peripheral actions of serotonin and histamine in increasing the membrane permeability of cranial vessels and transudation of plasmakinin, while altering pain thresholds in migraines. By blocking 5-HT receptors, pizotifen attenuates the signalling of serotonin in causing cranial vasoconstriction, as well as serotonin-enhanced platelet function and aggregation. There is evidence that it also inhibits the peripheral actions of bradykinin. Pizotifen may inhibit serotonin reuptake by blood platelets, which affects the tonicity and decreases passive distension of extracranial arteries. The effects of pizotifen leading to appetite stimulation may be due to the drug acting at the metabolic level rather than a direct stimulation of the appetite centre.
","Adults: Usually 1.5 mg daily. This may be taken as a single dose at night or in three divided doses. Dosage should be adjusted to the individual patient requirements up to a maximum of 4.5 mg daily. Up to 3 mg may be given as a single dose.
Children (aged over 2 years): Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been given as a single dose at night.
",,"The central effects of sedatives, hypnotics, antihistamines (including certain common cold preparations) and alcohol may be enhanced by Pizotifen. Pizotifen antagonizes the hypotensive effect of adrenergic neurone blockers.
","Pizotifen is contraindicated in patients with known hypersensitivity to any of its ingredients.
","The most common side effects are appetite stimulating effect, increase in body weight and drowsiness.
","Information of using Pizotifen in pregnancy is limited, although no ill effects have been reported. The drug should therefore only be given during pregnancy if the potential benefit to mother justifies the potential risk to the fetus. The safety of Pizotifen during lactation has not been established, so mothers should avoid taking it when breast feeding.
","Urinary retention, renal impairment should be taken in consideration. Drowsiness may affect the performance driving vehicles & operation of machineries. Pizotifen enhances the action of alcohol.
",,,,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",10
+894,Pivmecillinam,pivmecillinam-894,https://medex.com.bd/attachments/kwxoRUbip48uIu5RKSq8eCe42JbG03/pivmecillinam-prescribing-information,Mecillinams,Shigellosis,"Pivmecillinam is indicated for treatment of infections caused by mecillinam-sensitive organisms, e.g. acute cystitis, complicated urinary tract infections, salmonellosis, shigellosis, enteropathic E. coli diarrhoea, gram-negative septicaemia, billiary infections.
","Mecillinams
","Pivmecillinam belongs to a new class of penicillin-the amdinopenicillin. Pivmecillinam is a prodrug formulation of mecillinam which allows the drug to be administered by mouth. The prodrug form lacks antibacterial activity, but the active drug is liberated by enzymatic hydrolysis during absorption in the gastrointestinal tract.
Pivmecillinam is bactericidal. It acts by interfering with bacterial cell wall synthesis, but the site of action differs from that of other penicilins. Pivmecillinam is very active against Enterobacteriaceae. It is active against E. coli, Klebsiella, Proteus, Enterobacter, Salmonella, Shigella and Yersinia. Pivmecillinam has poor activity against Gram- positive organisms. It has poor activity against Pseudomonas aeruginosa and has practically no activity against Enterococcus faecalis.
","Adults:
+
+- The usual dose: 1-2 tablets 3 times daily according to severity of the infection.
+- In acute uncomplicated cystitis: initially 400 mg then 200 mg every 8 hours for 3 days.
+- In chronic or recurrent bacteriurea: 400 mg 6-8 hours.
+- For the treatment of salmonellosis (including enteric fever): 1.2-2.4 gm daily for 14 days. To eliminate salmonella carriage, therapy may be prolonged for 2-4 weeks. In complicated urinary tract infection the usual treatment time is 1-2 weeks.
+- For prophylactic treatment of recurrent urinary tract infections: 1 tablet every evening is recommended.
+
+Children:
+
+- Weighing less than 20 kg should be given 20-60 mg/kg divided into 3-4 daily doses. Those weighing more than 20 kg should receive normal adult dose.
+- In shigellosis: 20 mg/kg 4 times a day for 5 days.
+- For UTI: 20-40 mg/kg/day in 3-4 divided doses
+- For salmonellosis: 30-60 mg/kg/day in 3-4 divided doses
+
","The tablet should be taken with at least 50-100 ml fluid. As the bioavailability is practically unaffected by simultaneous food intake, This tablets are best taken with or immediately after a meal.
",,"There have been no reports on allergy to Pivmecillinam among patients with a known history of hypersensitivity to penicillins and cephalosporins. Nevertheless, it seems reasonable to exclude such patients from treatment with Pivmecillinam until further experience has been gained.
","Pivmecillinam is generally well tolerated, even by patients with reduced kidney function. Upper gastrointestinal disturbances such as nausea, vomiting and diarrhoea or indigestion may occur when a dose has been given on an empty stomach. Skin rashes have been reported in some cases, but the characteristic ampicillin-rash has never been observed, nor has there been any evidence of hepato-, nephro-, or ototoxicity. The occurrence of anaphylaxis, though not yet reported, cannot be entirely excluded.
","Mecillinam concentrations approximately 1/3 of the serum levels have been found in the umbilical cord, and low but detectable amounts in the amniotic fluid. So, use of pivmecillinam in pregnancy should be avoided. Mecillinam is not excreted into the milk of lactating mother
","As with other antibiotics, which are excreted mainly by the kidneys, raised blood levels of mecillinam may occur if repeated doses are given with impaired renal function.
","Based on information available to date for patients with impaired renal function, the initial dose can remain unchanged as can the interval between doses. However, the amount administered as the maintenance dose should be changed according to the following criteria:
+
+- CrCl 30 ml/min or greater: full dosage
+- CrCl 10-30 ml/min: 50% dosage
+- CrCl <10 ml/min: 25% dosage
+
+Use of Pivmecillinam in infants under 3 months of age should be avoided.
","There is no experience with over dosage of pivmecillinam. However, excessive doses are likely to cause nausea, vomiting and gastritis. Treatment should be restricted to symptomatic and supportive measures. If necessary haemodialysis will reduce the blood level.
",,,"Store at a cool and dry place, protect from light and moisture.
",12
+893,Pitavastatin Calcium,pitavastatin-calcium-893,https://medex.com.bd/attachments/mMktZbt1O3u8o1oLe5Yso5GDOv1KNv/pitavastatin-calcium-prescribing-information,Other Anti-anginal & Anti-ischaemic drugs,Obesity,"Pitavastatin is indicated as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG) and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia.
","Other Anti-anginal & Anti-ischaemic drugs, Statins
","Pitavastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.
","The dose range for Pitavastatin is 1 to 4 mg orally once daily at any time of the day with or without food. The recommended starting dose is 2 mg and the maximum dose is 4 mg. After initiation or upon titration of Pitavastatin, lipid levels should be analyzed after 4 weeks and the dosage adjusted accordingly.
Dosage in Patients with Renal Impairment: Patients with moderate renal impairment and end–stage renal disease receiving hemodialysis should receive a starting dose of Pitavastatin 1 mg once daily and a maximum dose of Pitavastatin 2 mg once daily. Pitavastatin should not be used in patients with severe renal impairment.
",,"Cyclosporine: Co-administration of cyclosporine with Pitavastatin is contraindicated.
Erythromycin: Erythromycin significantly increased Pitavastatin exposure. In patients taking erythromycin, a dose of Pitavastatin 1 mg once daily should not be exceeded.
Rifampin: Rifampin significantly increased Pitavastatin exposure. In patients taking rifampin, a dose of Pitavastatin 2 mg once daily should not be exceeded.
Fibrates: Pitavastatin should be administered with caution when used concomitantly with gemfibrozil or other fibrates.
Warfarin: Pitavastatin had no significant pharmacokinetic interaction with warfarin.
","Patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions including rash, pruritus and urticaria have been reported with Pitavastatin. Patients with active liver disease which may include unexplained persistent elevations of hepatic transaminase levels.
","Rhabdomyolysis, myopathy and Liver enzyme abnormalities.
","Pregnancy Category X. Pitavastatin is contraindicated in women who are or may become pregnant. It is not known whether Pitavastatin is excreted in human milk, however, it has been shown that a small amount of another drug in this class passes into human milk.
","Pitavastatin should be prescribed with caution in patients with predisposing factors for myopathy. These factors include advanced age (>65 years), renal impairment, and inadequately treated hypothyroidism. Increase in serum transaminases have been reported with HMG-CoA reductase inhibitors, including Pitavastatin. In most cases, the elevations were transient and resolved or improved on continued therapy or after a brief interruption in therapy.
",,"There is no known specific treatment in the event of overdose of Pitavastatin. In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required. Hemodialysis is unlikely to be of benefit due to high protein binding ratio of Pitavastatin.
",,,"Store in a cool and dry place, protect from light & moisture . Keep out of the reach of children.
",11
+1407,Pirfenidone,pirfenidone-1407,https://medex.com.bd/attachments/8c5plnmbkpG9chkNQn66qTdGpLXeRc/pirfenidone-prescribing-information,Immunosuppressant,Idiopathic Pulmonary Fibrosis,"Pirfenidone is indicated in adults for the treatment of mild to moderate Idiopathic Pulmonary Fibrosis (IPF).
","Immunosuppressant
","Pirfenidone is an orally active, small molecule that shows a wide range of biologic activity. In vitro evidence has shown that pirfenidone inhibits collagen synthesis, down-regulates profibrotic cytokines and decreases fibroblast proliferation. Pirfenidone leads to a reduction of TGF-beta2 mRNA levels and of the mature TGF-beta2 protein due to decreased expression and direct inhibition of the TGF-beta pro-protein convertase furin. In addition, pirfenidone reduces the protein levels of the matrix metalloproteinase (MMP)-11, a TGF-beta target gene and furin substrate involved in carcinogenesis.
","Treatment with Pirfenidone should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of IPF. Upon initiating treatment, the dose should be titrated to the recommended daily dose of nine 267 mg tablets or one 801 mg tablet per day over a 14-days period for adult as follows:
+
+- Days 1 to 7: One 267 mg tablet administered three times a day (801 mg/day)
+- Days 8 to 14: One 534 mg tablets administered three times a day (1602 mg/day)
+- Day 15 onward: Three 267 mg tablets or one 801 mg tablet administered three times a day (2403 mg/day)
+
+The recommended daily dose of Pirfenidone for patients with IPF is three 267 mg tablets or one 801 mg three times a day with food for a total of 2403 mg/day. Doses above 2403 mg/day are not recommended for any patient. Patients who miss 14 consecutive days or more of Pirfenidone treatment should re-initiate therapy by undergoing the initial 2-week titration regimen up to the recommended daily dose. For treatment interruption of less than 14 consecutive days, the dose can be resumed at the previous recommended daily dose without titration.
Dose adjustments and other considerations for safe use: Gastrointestinal events: In patients who experience intolerance to therapy due to gastrointestinal side effects, patients should be reminded to take the medicinal product with food. If symptoms persist Pirfenidone may be reduced to 1-2 capsules (267 mg-534 mg) 2-3 times/day with food with re-escalation to the recommended daily dose as tolerated. If symptoms continue, patients may be instructed to interrupt treatment for 1 to 2 weeks to allow symptoms to resolve.
Photosensitivity reaction or rash: Patients who experience a mild to moderate photosensitivity reaction or rash should be reminded of the instruction to use a sunblock daily and to avoid sun exposure. The dose of Pirfenidone may be reduced to 3 capsules/day (1 capsule three times a day). If the rash persists after 7 days, Pirfenidone should be discontinued for 15 days, with re-escalation to the recommended daily dose in the same manner as the dose escalation period. Patients who experience severe photosensitivity reaction or rash should be instructed to interrupt the dose and to seek medical advice. Once the rash has resolved, Pirfenidone may be re-introduced and re-escalated up to the recommended daily dose at the discretion of the physician.
Hepatic function: In the event of significant elevation of alanine and/or aspartate aminotransferases (ALT/AST) with or without bilirubin elevation, the dose of Pirfenidone should be adjusted or treatment discontinued according to the guidelines.
",,,"Hypersensitivity to the active substance or to any of the excipients, concomitant use of fluvoxamine, severe hepatic impairment or end stage liver disease, severe renal impairment (CrCl <30 ml/min) or end stage renal disease requiring dialysis.
Hepatic function: Elevations in ALT and AST >3 × upper limit of normal (ULN) have been reported in patients receiving therapy with Pirfenidone. Rarely these have been associated with concomitant elevations in total serum bilirubin. Liver function tests (ALT, AST and bilirubin) should be conducted prior to the initiation of treatment with Pirfenidone, and subsequently at monthly intervals for the first 6 months and then every 3 months thereafter. In the event of significant elevation of liver aminotransferases the dose of Pirfenidone should be adjusted or treatment discontinued according to the guidelines listed below. For patients with confirmed elevations in ALT, AST or bilirubin during treatment, the following dose adjustments may be necessary.
Recommendations in case of ALT/AST elevations: If a patient exhibits an aminotransferase elevation to >3 to ≤5 X ULN after starting Pirfenidone therapy, confounding medicinal products should be discontinued, other causes excluded, and the patient monitored closely. If clinically appropriate the dose of Pirfenidone should be reduced or interrupted. Once liver function tests are within normal limits Pirfenidone may be re-escalated to the recommended daily dose if tolerated. If a patient exhibits an aminotransferase elevation to >5 X ULN accompanied by symptoms or hyperbilirubinaemia, Pirfenidone should be discontinued and the patient should not be rechallenged. If a patient exhibits an aminotransferase elevation to >5 X ULN, Pirfenidone should be discontinued and the patient should not be rechallenged.
Hepatic impairment: In subjects with moderate hepatic impairment (i.e. Child-Pugh Class B), Pirfenidone exposure was increased by 60%. Pirfenidone should be used with caution in patients with pre-existing mild to moderate hepatic impairment (i.e. Child-Pugh Class A and B) given the potential for increased Pirfenidone exposure. Patients should be monitored closely for signs of toxicity especially if they are concomitantly taking a known CYP1A2 inhibitor. Pirfenidone has not been studied in individuals with severe hepatic impairment and Pirfenidone should not be used in patients with severe hepatic impairment.
Photosensitivity reaction and rash: Exposure to direct sunlight (including sunlamps) should be avoided or minimised during treatment with Pirfenidone. Patients should be instructed to use a sunblock daily, to wear clothing that protects against sun exposure, and to avoid other medicinal products known to cause photosensitivity. Patients should be instructed to report symptoms of photosensitivity reaction or rash to their physician. Severe photosensitivity reactions are uncommon. Dose adjustments or temporary treatment discontinuation may be necessary in mild to severe cases of photosensitivity reaction or rash.
Dizziness: Dizziness has been reported in patients taking Pirfenidone. Therefore, patients should know how they react to this medicinal product before they engage in activities requiring mental alertness or coordination. In clinical studies, most patients who experienced dizziness had a single event, and most events resolved, with a median duration of 22 days. If dizziness does not improve or if it worsens in severity, dose adjustment or even discontinuation of Pirfenidone may be warranted.
Fatigue: Fatigue has been reported in patients taking Pirfenidone. Therefore, patients should know how they react to this medicinal product before they engage in activities requiring mental alertness or coordination.
Weight loss: Weight loss has been reported in patients treated with Pirfenidone. Physicians should monitor patients’ weight, and when appropriate encourage increased caloric intake if weight loss is considered to be of clinical significance. Interactions with other medicinal products and other forms of interaction. Approximately 70-80% of pirfenidone is metabolised via CYP1A2 with minor contributions from other CYP isoenzymes including CYP2C9, 2C19, 2D6 and 2E1. Consumption of grapefruit juice is associated with inhibition of CYP1A2 and should be avoided during treatment with pirfenidone.
Fluvoxamine and inhibitors of CYP1A2: In a Phase 1 study, the co-administration of Pirfenidone and fluvoxamine (a strong inhibitor of CYP1A2 with inhibitory effects on other CYP isoenzymes [CYP2C9, 2C19, and 2D6]) resulted in a 4-fold increase in exposure to pirfenidone in non-smokers. Pirfenidone is contraindicated in patients with concomitant use of fluvoxamine. Fluvoxamine should be discontinued prior to the initiation of Pirfenidone therapy and avoided during Pirfenidone therapy due to the reduced clearance of pirfenidone. Other therapies that are inhibitors of both CYP1A2 and one or more other CYP isoenzymes involved in the metabolism of pirfenidone (e.g. CYP2C9, 2C19, and 2D6) should be avoided during pirfenidone treatment. In vitro in vivo extrapolations indicate that strong and selective inhibitors of CYP1A2 (e.g. enoxacin) have the potential to increase the exposure to pirfenidone by approximately 2 to 4-fold. If concomitant use of Pirfenidone with a strong and selective inhibitor of CYP1A2 cannot be avoided, the dose of Pirfenidone should be reduced to 801 mg daily (one capsule, three times a day). Patients should be closely monitored for emergence of adverse reactions associated with Pirfenidone therapy. Discontinue Pirfenidone if necessary.
Co-administration of Pirfenidone and 750 mg of ciprofloxacin (a moderate inhibitor of CYP1A2) increased the exposure to pirfenidone by 81%. If ciprofloxacin at the dose of 750 mg twice daily cannot be avoided, the dose of Pirfenidone should be reduced to 1602 mg daily (two capsules, three times a day). Pirfenidone should be used with caution when ciprofloxacin is used at a dose of 250 mg or 500 mg once or twice daily. Pirfenidone should be used with caution in patients treated with other moderate inhibitors of CYP1A2 (e.g. amiodarone, propafenone). Special care should also be exercised if CYP1A2 inhibitors are being used concomitantly with potent inhibitors of one or more other CYP isoenzymes involved in the metabolism of pirfenidone such as CYP2C9 (e.g. amiodarone, fluconazole), 2C19 (e.g. chloramphenicol) and 2D6 (e.g. fluoxetine, paroxetine).
Cigarette smoking and inducers of CYP1A2: A Phase 1 interaction study evaluated the effect of cigarette smoking (CYP1A2 inducer) on the pharmacokinetics of Pirfenidone. The exposure to pirfenidone in smokers was 50% of that observed in non-smokers. Smoking has the potential to induce hepatic enzyme production and thus increase medicinal product clearance and decrease exposure. Concomitant use of strong inducers of CYP1A2 including smoking should be avoided during Pirfenidone therapy based on the observed relationship between cigarette smoking and its potential to induce CYP1A2. Patients should be encouraged to discontinue use of strong inducers of CYP1A2 and to stop smoking before and during treatment with pirfenidone. In the case of moderate inducers of CYP1A2 (e.g. omeprazole), concomitant use may theoretically result in a lowering of pirfenidone plasma levels. Co-administration of medicinal products that act as potent inducers of both CYP1A2 and the other CYP isoenzymes involved in the metabolism of pirfenidone (e.g. rifampicin) may result in significant lowering of pirfenidone plasma levels. These medicinal products should be avoided whenever possible.
","The safety of Pirfenidone has been evaluated in clinical studies including 1345 healthy volunteers and patients. The most commonly reported (10%) adverse reactions during clinical study experience with Pirfenidone at a dose of 2403 mg/day compared to placebo, respectively, were nausea (32.8% versus 13.3%), rash (28.7% versus 8.6%), fatigue (22.3% versus 13.3%), diarrhoea (21.7% versus 13.5%), dyspepsia (16.8% versus 5.5%), and photosensitivity reaction (12.2% versus 1.7%). Serious adverse reactions were recorded at similar frequencies among patients treated with 2403 mg/day of Pirfenidone and placebo in clinical studies. The adverse reactions reported at a frequency of 2% in 345 patients receiving Pirfenidone at the recommended dose of 2403 mg/day in two pivotal Phase 3 studies. Adverse reactions from post-marketing experience are also listed. Adverse reactions are listed by System Organ Class (SOC) and within each frequency grouping the adverse reactions are presented in order of decreasing seriousness.
","Pregnancy: There are no data from the use of Pirfenidone in pregnant women. In animals placental transfer of pirfenidone and/or its metabolites occurs with the potential for accumulation of pirfenidone and/or its metabolites in amniotic fluid. At high doses (1000 mg/kg/day) rats exhibited prolongation of gestation and reduction in fetal viability. As a precautionary measure, it is preferable to avoid the use of Pirfenidone during pregnancy.
Lactation: It is unknown whether pirfenidone or its metabolites are excreted in human milk. Available pharmacokinetic data in animals have shown excretion of pirfenidone and/or its metabolites in milk with the potential for accumulation of pirfenidone and/or its metabolites in milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue from Pirfenidone therapy, taking into account the benefit of breast-feeding for the child and the benefit of Pirfenidone therapy for the mother.
Fertility: No adverse effects on fertility were observed in preclinical studies. Effects on ability to drive and use machines: No studies on the effects of the ability to drive and use machines have been performed. Pirfenidone may cause dizziness and fatigue, which could influence the ability to drive or use machines.
",,,"There is limited clinical experience with overdose. Multiple doses of pirfenidone up to a dose of 4806 mg/day were administered as six 267 mg capsules three times daily to healthy adult volunteers over a 12-day dose escalation period. Adverse reactions were mild, transient, and consistent with the most frequently reported adverse reactions for pirfenidone.
",,,"Store in a cool and dry place, protected from light.
",9
+891,Piracetam,piracetam-891,,Adjunct anti-epileptic drugs,Cortical myoclonus,"Cerebral vascular accidents and cerebral insufficiencies: Ischaemic or even haemorrhagic acute accidents, chronic manifestations of the above accidents or of cerebral atherosclerosis.
Mental retardation in children: Ease of resuming individual contact ... Read more
Cerebral vascular accidents and cerebral insufficiencies: Ischaemic or even haemorrhagic acute accidents, chronic manifestations of the above accidents or of cerebral atherosclerosis.
Mental retardation in children: Ease of resuming individual contact, sociability and learning, improved intellectual performances and school results.
Behaviour and psychotic problems in old age: Memory deficits, particularly with regard to fixation and evocation asthenia adaption disorders, disturbed psychomotor reactions. Patients suffering from myoclonus of cortical origin.
","Adjunct anti-epileptic drugs, Drugs used in tremor, tics & related disorder
","Piracetam's mechanism of action is not fully understood. The drug influences neuronal and vascular functions and influences cognitive function without acting as a sedative or stimulant. Piracetam is a positive allosteric modulator of the AMPA receptor. It is hypothesized to act on ion channels or ion carriers, thus leading to increased neuron excitability. GABA brain metabolism and GABA receptors are not affected by piracetam
It has been found to increase blood flow and oxygen consumption in parts of the brain, but this may be a side effect of increased brain activity rather than a primary effect or mechanism of action for the drug.
Piracetam improves the function of the neurotransmitter acetylcholine via muscarinic cholinergic (ACh) receptors, which are implicated in memory processes. Furthermore, piracetam may have an effect on NMDA glutamate receptors, which are involved with learning and memory processes. Piracetam is thought to increase cell membrane permeability. Piracetam may exert its global effect on brain neurotransmission via modulation of ion channels (i.e., Na+, K+). It has been found to increase oxygen consumption in the brain, apparently in connection to ATP metabolism, and increases the activity of adenylate kinase in rat brains. Piracetam, while in the brain, appears to increase the synthesis of cytochrome b5, which is a part of the electron transport mechanism in mitochondria. But in the brain, it also increases the permeability of the mitochondria of some intermediaries of the Krebs cycle.
","Oral: Adults:
+
+- In cerebro-cortical insufficiency disorders, usual dose is one tablet (800 mg) 3 times a day.
+- In myoclonic seizures, a dose of 7.2 gm daily, increasing by 4.8 gm per day every 3 to 4 days up to maximum of 20 gm daily, given in 2 or 3 divided doses.
+
+
Oral: Children: The daily dosage depends on the weight of the child, 50 mg/kg of body weight in 3 divided doses. Once the desired results has been obtained, reduce the initial dose by half.
Parenteral formulations: When parenteral administration is needed (e.g. swallowing difficulties, unconsciousness) Piracetam can be administered intravenously. When treating severe symptoms, 12 g daily may need to be administered as an intravenous infusion.
",,"In a single case, confusion, irritability and sleep disorders were reported in concomitant use with thyroid extract. At present, no interaction has been observed with the following anti-epileptic drugs, clonazepam, carbamazepine, phenyton, phenobarbitone and sodium valporate, based on a small number of studies.
","Piracetam is contra-indicated in patients with severe renal insufficiency (creatinine clearance < 20 ml/min) and hepatic impairment. As the principal route of elimination for Piracetam is via the kidney, special care must be taken when treating patients known to suffer from renal insufficiency. Monitoring of renal function is recommended in such cases. The increase in half-life is directly related to the decrease in renal function and creatinine clearance. This is also true for the older patient in whom creatinine clearance is dependent on age. When the creatinine clearance is < 60 ml/min, or serum creatinine is >1.25 mg/100 ml, the dosage prescribed should be calculated as following:
CrCl 60-40 ml/min: Dosage should be 1/2 of normal dose
CrCl 40-20 ml/min: Dosage should be 1/4 of normal dose
","The side effects reported include nervousness, agitation, irritability, anxiety and sleep disturbances. The incidence of these during clinical trials was (≤ 5%) and they were more often noted in the older patients taking > 2.4 gm daily. In the majority of cases, a dose reduction sufficed to make these symptoms disappear. Some patients may complain of fatigue or drowsiness, gastrointestinal problems, e.g. nausea, vomiting, diarrhoea and stomachache have also been reported but their incidence during clinical trials was ≤ 2%. Other symptoms e.g. vertigo, headache, trembling and sexual stimulation have occasionally been reported.
","Piracetam should not be prescribed during pregnancy or when breast feeding, except under exceptional circumstances. Piracetam is able to cross the placenta.
",,"Children: No formal pharmacokinetic study has been conducted in children.
Elderly: In the elderly, the half-life of piracetam is increased and the increase is related to the decrease in renal function in this population (see Section Dosage and Administration).
Renal impairment: Piracetam clearance is correlated to creatinine clearance. It is therefore recommended to adjust the daily dose of piracetam based on creatinine clearance in patients with renal impairment
Hepatic impairment: The influence of hepatic impairment on the pharmacokinetics of piracetam has not been evaluated. Because 80 to 100% of the dose is excreted in the urine as unchanged drug, hepatic impairment solely would not be expected to have a significant effect on piracetam elimination.
","Piracetam appears to be devoid of toxicity even at very high doses and, therefore, the need for specific measures to be taken in case of an overdose is avoided. Drug Interactions: In a single case, confusion, irritability and sleep disorders were reported in concomitant use with thyroid extract. At present, no interaction has been observed with the following anti-epileptic drugs, clonazepam, carbamazepine, phenytoin, phenobarbitone and sodium valproate, based on a small number of studies.
",,"Piracetam is compatible (physico-chemical compatibility) with the perfusions of:
+
+- Glucose 5%, 10%, 20%
+- Fructose 5%, 10%, 20%
+- Sodium chloride 0.9%
+- Dextran 40 (10% in a 0.9% NaCl solution)
+- Ringer Mannitol 20%
+- HES solution (Hydroxy Ethyl Starch) 6% and 10%
+
+The stability of these solutions has been demonstrated up to 24 hours.
","Store in a cool and dry place at a temperature below 30˚C , Keep away from sunlight. Keep out of the reach of children.
",12
+890,Piperacillin + Tazobactam,piperacillin-tazobactam-890,https://medex.com.bd/attachments/3xKYbptU8SUaBo2jCR6dBqDpoTaLDC/piperacillin-tazobactam-prescribing-information,Other beta-lactam Antibiotics,Skin and skin sructure infections,"Piperacillin and tazobactam is a combination product consisting of a penicillin-class antibacterial, piperacillin, and a β-lactamase inhibitor, tazobactam, indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in the ... Read more
Piperacillin and tazobactam is a combination product consisting of a penicillin-class antibacterial, piperacillin, and a β-lactamase inhibitor, tazobactam, indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in the conditions listed below.
Intra-abdominal Infections: Appendicitis (complicated by rupture or abscess) and peritonitis caused by β-lactamase producing isolates of Escherichia coli or the following members of the Bacteroides fragilis group: B. fragilis, B. ovatus, B. thetaiotaomicron, or B. vulgatus.
Skin and Skin Structure Infections: Uncomplicated and complicated skin and skin structure infections, including Cellulites, cutaneous abscesses and ischemic/diabetic foot infections caused by β-lactamase producing isolates of Staphylococcus aureus.
Female Pelvic Infections: Postpartum endometritis or pelvic inflammatory disease caused by β-lactamase producing isolates of Escherichia coli.
Community-acquired pneumonia: Community-acquired pneumonia (moderate severity only) caused by β lactamase producing isolates of Haemophilus influenzae.
Nosocomial pneumonia: Nosocomial pneumonia (moderate to severe) caused by β-lactamase producing isolates of Staphylococcus aureus and by piperacillin/tazobactam-susceptible Acinetobacter baumanii, Haemophilus influenzae, Klebsiella pneumoniae, and Pseudomonas aeruginosa (Nosocomial pneumonia caused by P. aeruginosa should be treated in combination with an aminoglycoside).
","Broad spectrum penicillins, Other beta-lactam Antibiotics
","Piperacillin, a broad spectrum, semi-synthetic penicillin active against many gram-positive and gram-negative aerobic and anaerobic bacteria, exerts bactericidal activity by inhibition of both septum and cell wall synthesis. Tazobactam is a potent inhibitor of many beta-lactamases, including the plasmid and chromosomally mediated enzymes that commonly cause resistance to penicillins. Tazobactam enhances and extends the antibiotic spectrum of Piperacillin to include many beta-lactamase-producing bacteria normally resistant to it. Thus, this infusion combines the properties of a broad-spectrum antibiotic and a beta-lactamase inhibitor.
","Piperacillin and tazobactam should be administered by intravenous infusion over 30 minutes.
Adult Patients: The usual total daily dose of Piperacillin and tazobactam for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g tazobactam). The usual duration of treatment is from 7 to 10 days.
Nosocomial Pneumonia: Initial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18.0 g (16.0 g piperacillin/2.0 g tazobactam). The recommended duration of the treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom Pseudomonas aeroginosa is isolated.
Pediatric Patients: For children with appendicitis and/or peritonitis 9 months of age or older, weighing up to 40 kg, and with normal renal function, the recommended piperacillin and tazobactam dosage is 100 mg piperacillin/12.5 mg tazobactam per kilogram of body weight, every 8 hours. For pediatric patients between 2 months and 9 months of age, the recommended dosage based on Pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose. It has not been determined how to adjust piperacillin and tazobactam dosage in pediatric patients with renal impairment.
",,"Aminoglycosides: Piperacillin may inactivate aminoglycosides by converting them to microbiologically inert amides. When aminoglycosides are administered in conjunction with piperacillin to patients with end-stage renal disease requiring hemodialysis, the concentrations of the aminoglycosides (especially tobramycin) may be significantly reduced and should be monitored.
Sequential administration of pipercillin and tazobactam and tobramycin to patients with either normal renal function or mild to moderate renal impairment has been shown to modestly decrease serum concentrations of tobramycin but no dosage adjustment is considered necessary.
Probenecid: Probenecid administered concomitantly with piperacillin and tazobactam prolongs the half-life of piperacillin by 21% and that of tazobactam by 71% because probenecid inhibits tubular renal secretion of both piperacillin and tazobactam. Probenecid should not be co-administered with Pipercillin and tazobactam unless the benefit outweighs the risk.
Anticoagulants: Coagulation parameters should be tested more frequently and monitored regularly during simultaneous administration of high doses of heparin, oral anticoagulants, or other drugs that may affect the blood coagulation system or the thrombocyte function.
Vecuronium: Piperacillin when used concomitantly with vecuronium has been implicated in the prolongation of the neuromuscular blockade of vacuronium, piperacillin and tazobactam could produce the same phenomenon if given along with vecuronium. Due to their similar mechanism of action, it is expected that the neuromuscular blockade produced by any of the non-depolarizing muscle relaxants could be prolonged in the presence of piperacillin.
Methotrexate: Limited data suggests that co-administration of methotrexate and piperacillin may reduce the clearance of methotrexate due to competition for renal secretion. The impact of tazobactam on the elimination of methotrexate has not been evaluated. If concurrent therapy is necessary, serum concentrations of methotrexate as well as the signs and symptoms of methotrexate toxicity should be frequently monitored.
","Piperacillin and tazobactam is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or β -lactamase inhibitors.
","Adverse events primarily involving the skin, including rash, pruritus and Purpura; the gastrointestinal system including diarrhea, Constipation, nausea, vomiting, Dyspepsia and Abdominal Pain; General disorders and administration site conditions including Fever, Injection site reaction (≤1%) and Rigors. (≤1%), Immune hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock) (≤1%), Infections-Candidiasis and Pseudomembranous colitis (≤1%), Metabolism and nutrition disorders- Hypoglycemia (≤1%), Musculoskeletal and connective tissue disorders- Myalgia and Arthralgia (≤1%), Psychiatric disorders Insomnia, Vascular disorders- Phlebitis Thrombophlebitis(≤1%), Hypotension(≤1%), Flushing(≤1%), Respiratory, thoracic and mediastinal disorders- Epistaxis (≤1%).
","Piperacillin and tazobactam cross the placenta in humans. However, there are insufficient data with piperacillin and/or tazobactam in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Piperacillin is excreted in human milk; tazobactam concentrations in human milk have not been studied. No information is available on the effects of piperacillin and tazobactam on the breastfed child or on milk production.
","Serious hypersensitivity reactions (anaphylactic/anaphylactoid) reactions have been reported in patients receiving Piperacillin and tazobactam. Discontinue Piperacillin and tazobactam if a reaction occurs.
Piperacillin and tazobactam may cause severe cutaneous adverse reactions, such as Stevens- Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis. Discontinue Piperacillin and tazobactam for progressive rashes.
Hematological effects (including bleeding, leukopenia and neutropenia) have occurred. Monitor hematologic tests during prolonged therapy.
Nephrotoxicity in critically ill patients has been observed; the use of Piperacillin and tazobactam was found to be an independent risk factor for renal failure and was associated with delayed recovery of renal function as compared to other beta-lactam antibacterial drugs in a randomized, multicenter, controlled trial in critically ill patients. Based on this study, alternative treatment options should be considered in the critically ill population. If alternative treatment options are inadequate or unavailable, monitor renal function during treatment with Piperacillin and tazobactam.
Clostridium difficile associated diarrhea: Evaluate patients if diarrhea occurs.
","Pediatric Use: Use of Piperacillin and tazobactam in pediatric patients 2 months of age or older with appendicitis and/or peritonitis is supported by evidence from well-controlled studies and pharmacokinetic studies in adults and in pediatric patients. It has not been determined how to adjust Piperacillin and tazobactam dosage in pediatric patients with renal impairment.
Geriatric Use: Patients over 65 years are not at an increased risk of developing adverse effects solely because of age. However, dosage should be adjusted in the presence of renal impairment. This may be clinically important with regard to such diseases as congestive heart failure.
Renal Impairment: In patients with creatinine clearance ≤40 mL/min and dialysis patients (hemodialysis and CAPD), the intravenous dose of Piperacillin and tazobactam should be reduced to the degree of renal function impairment.
Hepatic Impairment: Dosage adjustment of Piperacillin and tazobactam is not warranted in patients with hepatic cirrhosis.
Patients with Cystic Fibrosis: As with other semisynthetic penicillins, piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients
","There have been post marketing reports of overdose with piperacillin/tazobactam. The majority of those events experienced, including nausea, vomiting, and diarrhea, have also been reported with the usual recommended dosages. Patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given intravenously (particularly in the presence of renal failure). Treatment should be supportive and symptomatic according the patient's clinical presentation.
",,"Administration by intravenous infusion should be continued over 30 minutes. Withdraw 20 ml diluent (0.9% w/v Sodium Chloride solution) by the disposable syringe and push into the vial containing Piperacillin and Tazobactam powder. Mix to become the vial contents a complete solution. Withdraw the total solution by the syringe and push into the bottle of 0.9% w/v Sodium Chloride solution. Vials should be used immediately after reconstitution. Discard any unused portion after 24 hours if stored at room temperature (20°C to 25°C) or after 48 hours if stored at refrigerated temperature (20°C to 80°C). Vials should not be frozen after reconstitution. Prior to reconstitution, store piperacillin and tazobactam powder for intravenous infusion at controlled room temperature 20°-25° C. Protect from light and keep out of children's reach.
","Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",13
+889,Pipecuronium Bromide,pipecuronium-bromide-889,,Non depolarizing muscle relaxants,Muscle relaxant in general anesthesia,"Used as a muscle relaxant during anesthesia and surgical procedures.
","Non depolarizing muscle relaxants
","Pipecuronium is a nondepolarizing neuromuscular blocking agent. Neuromuscular blocking agents produce skeletal muscle paralysis by blocking neural transmission at the myoneural junction. The paralysis is selective initially and usually appears in the following muscles consecutively: levator muscles of eyelids, muscles of mastication, limb muscles, abdominal muscles, muscles of the glottis, and finally, the intercostal muscles and the diaphragm. Neuromuscular blocking agents have no clinically significant effect on consciousness or the pain threshold.
Nondepolarizing neuromuscular blocking agents inhibit neuromuscular transmission by competing with acetylcholine for the cholinergic receptors of the motor end plate, thereby reducing the response of the end plate to acetylcholine. This type of neuromuscular block is usually antagonized by anticholinesterase agents.
","Intravenous (Adult)-
+
+- Initial dose: 80-100 mcg/kg.
+- Subsequent doses: 10-20 mcg/kg.
+- Initial dose following suxamethonium admin or in patients at high risk: 50-60 mcg/kg.
+- Initial dose for caesarean section: 35 mcg/kg.
+
",,"Actions antagonised by cholinesterases and long term carbamazepine, phenytoin or corticosteroids usage. Enhanced block when used with drugs that have neuromuscular blocking activity such as lidocaine, quinidine, verapamil and aminoglycosides.
","Hypersensitivity.
","Transient hypotension, bradycardia, reduced cardiac output.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Pulmonary disease, respiratory insufficiency, asthma, neuromuscular disease, dehydration, severely ill patients, hepatic or renal impairment. Doses in obese patients should be based on patient's ideal body weight. Pregnancy, lactation.
",,"Prolonged apnoea due to paralysis of the intercostal muscles and diaphragm, with CV collapse and effects of histamine release.
",,,,10
+735,Pioglitazone + Metformin Hydrochloride,pioglitazone-metformin-hydrochloride-735,https://medex.com.bd/attachments/YUTF1uJ9YcpE3J0omvTRwXp2oNzPhc/pioglitazone-metformin-hydrochloride-prescribing-information,Combination Oral hypoglycemic preparations,Type 2 DM,"Pioglitazone & Metformin combination is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes who are already treated with a combination of Pioglitazone and Metformin or whose diabetes is not adequately controlled with Metformin alone or for those patients who have initially responded to Pioglitazone and require additional glycemic control.
","Combination Oral hypoglycemic preparations
","Pioglitazone depends on the presence of insulin for its mechanism of action. Pioglitazone decreases insulin resistance in the periphery and in the liver resulting in increased insulindependent glucose disposal and decreased hepatic glucose output. Pioglitazone is a potent and highly selective agonist for peroxisome proliferator-activated receptor-gamma (PPARg). Activation of PPARg nuclear receptors modulates the transcription of a number of insulin responsive genes involved in the control of glucose and lipid metabolism.
Metformin hydrochloride improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects and does not cause hyperinsulinemia.
","General: The use of antihyperglycemic therapy in the management of type 2 diabetes should be individualized on the basis of effectiveness and tolerability while not exceeding the maximum recommended daily dose of Pioglitazone 45 mg and Metformin 2550 mg.
Dosage Recommendations: Selecting the starting dose of Pioglitazone & Metformin should be based on the patient's current regimen of Pioglitazone and/or Metformin. Pioglitazone & Metformin should be given in divided daily doses with meals to reduce the gastrointestinal side effects associated with Metformin.
Starting dose for patients inadequately controlled on Metformin monotherapy Based on the usual starting dose of Pioglitazone (15-30 mg daily), Pioglitazone & Metformin may be initiated at either the 15 mg/500 mg or 15 mg/850 mg tablet strength once or twice daily, and gradually titrated after assessing adequacy of therapeutic response. Starting dose for patients who initially responded to Pioglitazone monotherapy and require additional glycemic control
Based on the usual starting doses of Metformin (500 mg twice daily or 850 mg daily), Pioglitazone & Metformin may be initiated at either the 15 mg/500 mg twice daily or 15 mg/850 mg tablet strength once daily, and gradually titrated after assessing adequacy of therapeutic response.
Starting dose for patients switching from combination therapy of Pioglitazone plus Metformin as separate tablets Pioglitazone & Metformin may be initiated with either the 15 mg/500 mg or 15 mg/850 mg tablet strengths based on the dose of Pioglitazone and Metformin already being taken.
Maximum Recommended Dose: Pioglitazone & Metformin tablets are available as a 15 mg Pioglitazone plus 500 mg Metformin or a 15 mg Pioglitazone plus 850 mg Metformin formulation for oral administration. The maximum recommended dose for Pioglitazone is 45 mg daily. The maximum recommended daily dose for Metformin is 2550 mg in adults. Special Patient Populations: The initial and maintenance dosing of combination of Pioglitazone and Metformin should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of combination of Pioglitazone and Metformin. Monitoring of renal function is necessary to aid in prevention of Metformin associated lactic acidosis, particularly in the elderly. Therapy with combination of Pioglitazone and Metformin should not be initiated if the patient exhibits clinical evidence of active liver disease or increased serumtransaminase levels (ALT greater than 2.5 times the upper limit of normal) at start of therapy. Liver enzyme monitoring is recommended in all patients prior to initiation of therapy with combination of Pioglitazone and Metformin and periodically thereafter
",,"May impair vit B12 absorption. Increased plasma levels with strong CYP2C8 inhibitors (e.g. gemfibrozil). Decreased plasma levels with CYP2C8 inducers (e.g. rifampicin). Reduced metabolism with cationic drugs eliminated by renal tubular secretion.
","Contraindicated in patients with:
+
+- Renal disease or renal dysfunction (e.g. as suggested by serum creatinine levels >1.5 mg/dl in male, >1.4 mg/dl in females or abnormal creatinine clearance), which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction and septicemia.
+- Known hypersensitivity to Pioglitazone, Metformin or any other component of this combination.
+- Acute or chronic metabolic acidosis including diabetic ketoacidosis with or without coma.
+
","Generally this combined preparation is well tolerated. However, the most common side effects are upper respiratory tract infection, diarrhea, peripheral edema and headache, respectively. These are mild in severity.
","Pregnancy: There are no adequate and well-controlled studies in pregnant women with this combination or its individual components. So, it should only be used if the potential benefit justifies the potential risk to the fetus.
Nursing mother: It is not known whether Pioglitazone and/or Metformin are secreted in human milk. Because many drugs are excreted in human milk, this combination should not be administered to a breastfeeding woman.
","Pioglitazone exerts its antihyperglycemic effect only in the presence of insulin. Therefore, Pioglitazone should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Pioglitazone should be used with caution in combination especially with insulin, hepatic insufficiency and heart diseases.
Metformin is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Thus patients with serum creatinine levels above the upper limit of normal for their age should not receive this combination.
","The initial and maintenance dose of Pioglitazone & Metformin should be carefully selected in patients with advanced age due to the potential for decreased renal function in these populations. Monitoring of renal function is necessary to aid in prevention of Metformin associated lactic acidosis, particularly in the elderly. Pioglitazone & Metformin should not be initiated if the patients exhibit clinical evidence of active liver disease. Liver enzyme monitoring is recommended in all patients prior to initiation of therapy with combination of Pioglitazone and Metformin and periodically thereafter.
","In the event of Overdosage, appropriate supportive treatment should be initiated according to patient's clinical signs and symptoms.
",,,"Store in a cool and dry place. Protect from light and moisture. Keep out of the reach of the children.
",12
+525,Pioglitazone + Glimepiride,pioglitazone-glimepiride-525,https://medex.com.bd/attachments/5q5GhOnSdO5GccPLGLGgXcq5XX7hrS/pioglitazone-glimepiride-prescribing-information,Combination Oral hypoglycemic preparations,Type 2 DM,"This is indicated as an adjunct to diet and exercise as a once-daily combination therapy to improve glycemic control in patients with type 2 diabetes who are already treated with a combination of Pioglitazone and a sulfonylurea or whose diabetes is not adequately controlled with a sulfonylurea alone ... Read more
This is indicated as an adjunct to diet and exercise as a once-daily combination therapy to improve glycemic control in patients with type 2 diabetes who are already treated with a combination of Pioglitazone and a sulfonylurea or whose diabetes is not adequately controlled with a sulfonylurea alone, or for those patients who have initially responded to Pioglitazone alone and require additional glycemic control.
","Combination Oral hypoglycemic preparations
","Pioglitazone & Glimepiride combines two antihyperglycemic agents with different mechanisms of action to improve glycemic control in patients with type 2 diabetes: Pioglitazone, a member of the thiazolidinedione class, and Glimepiride, a member of the sulfonylurea class.
Pioglitazone is an insulin-sensitizing agent that acts primarily by enhancing peripheral glucose utilization. It depends on the presence of insulin for its mechanism of action. Pioglitazone decreases insulin resistance in the periphery and in the liver resulting in increased insulin dependent glucose disposal and decreased hepatic glucose output. Pioglitazone is a potent and highly selective agonist for peroxisome proliferator-activated receptor-gamma (PPARγ). Activation of PPARγ nuclear receptors modulates the transcription of a number of insulin responsive genes involved in the control of glucose and lipid metabolism.
The primary mechanism of action of Glimepiride in lowering blood glucose appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. In addition, extrapancreatic effects may also play a role in the activity of sulfonylureas such as Glimepiride. This is supported by both preclinical and clinical studies demonstrating that Glimepiride administration can lead to increased sensitivity of peripheral tissues to insulin.
","Selecting the starting dose of Glimepiride & Pioglitazone should be based on the patient's current regimen of Pioglitazone and/or sulfonylurea. Those patients who may be more sensitive to antihyperglycemic drugs should be monitored carefully during dose adjustment. It is recommended that a single dose of Pioglitazone & Glimepiride be administered once daily with the first main meal.
Starting dose for patients currently on Glimepiride monotherapy: Based on the usual starting dose of Pioglitazone (15 mg or 30 mg daily), Pioglitazone & Glimepiride may be initiated at 30 mg/2 mg or 30 mg/4 mg tablet strengths once daily, and adjusted after assessing adequacy of therapeutic response.
Starting dose for patients currently on Pioglitazone monotherapy: Based on the usual starting doses of Glimepiride (1 mg or 2 mg once daily), and Pioglitazone 15 mg or 30 mg, Pioglitazone & Glimepiride may be initiated at 30 mg/2 mg once daily, and adjusted after assessing adequacy of therapeutic response.
Starting dose for patients switching from combination therapy of Pioglitazone plus Glimepiride as separate tablets: Pioglitazone & Glimepiride may be initiated with 30 mg/2 mg or 30 mg/4 mg tablet strengths based on the dose of Pioglitazone and Glimepiride already being taken. Patients who are not controlled with 15 mg of Pioglitazone in combination with Glimepiride should be carefully monitored when switched to Pioglitazone & Glimepiride.
Starting dose for patients currently on a different sulfonylurea monotherapy or switching from combination therapy of Pioglitazone plus a different sulfonylurea: No exact dosage relationship exists between Glimepiride and the other sulfonylurea agents. Therefore, based on the maximum starting dose of 2 mg Glimepiride, Pioglitazone & Glimepiride should be limited initially to a starting dose of 30 mg/2 mg once daily, and adjusted after assessing adequacy of therapeutic response.
",,"Glimepiride: Certain drugs tend to produce hyperglycemia and may lead to loss of control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, and isoniazid. When these drugs are administered to a patient receiving Glimepiride, the patient should be closely observed for loss of control. When these drugs are withdrawn from a patient receiving Glimepiride, the patient should be observed closely for hypoglycemia. A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported. Whether this interaction also occurs with the IV, topical, or vaginal preparations of miconazole is not known. Potential interactions of Glimepiride with other drugs metabolized by cytochrome P450 2C9 also include phenytoin, diclofenac, ibuprofen, naproxen, and mefenamic acid.
Pioglitazone: Co-administration of Pioglitazone and an oral contraceptive resulted in decrease in ethinyl estradiol plasma concentrations. There were no significant changes in norethindrone AUC (0-24h) and Cmax. In other drug-drug interaction studies, Pioglitazone had no significant effect on the pharmacokinetics of fexofenadine, metformin, digoxin, warfarin, ranitidine, or theophylline.
","Combination of Pioglitazone and Glimepiride is contraindicated in patients with:
+
+- Known hypersensitivity to Pioglitazone or Glimepiride or any of the components of combination of Pioglitazone or Glimepiride.
+- Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.
+
","Pioglitazone: The most common adverse experiences with Pioglitazone monotherapy (≥5%) were upper respiratory tract infection, injury, and headache. Overall, the types of adverse experiences reported when Pioglitazone was used in combination with a sulfonylurea were similar to those during monotherapy with Pioglitazone. Other adverse events reported in at least 5% of patients in controlled clinical studies between placebo and Pioglitazone monotherapy included myalgia (2.7% and 5.4%), tooth disorder (2.3% and 5.3%), diabetes mellitus aggravated (8.1% and 5.1%) and pharyngitis (0.8% and 5.1%), respectively. In monotherapy studies, edema was reported for 4.8% (with doses from 7.5 mg to 45 mg) of patients treated with Pioglitazone versus 1.2% of placebo treated patients.
Glimepiride: Hypoglycemia: The incidence of hypoglycemia with Glimepiride is documented. In patients treated with Glimepiride, adverse events, other than hypoglycemia, considered to be possibly or probably related to study drug that occurred in more than 1% of patients included dizziness (1.7%), asthenia (1.6%), headache (1.5%), and nausea (1.1%). Dermatologic Reactions: Allergic skin reactions, e.g., pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions, occur in less than 1% of treated patients. These may be transient and may disappear despite continued use of Glimepiride.
","Pregnancy category C. Because current information strongly suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital anomalies as well as increased neonatal morbidity and mortality, most experts recommend that insulin monotherapy be used during pregnancy to maintain blood glucose levels as close to normal as possible. Combination of Pioglitazone and Glimepiride should not be used during pregnancy.
Nursing mothers: No studies have been conducted with combination of Pioglitazone and Glimepiride. It is not known whether Pioglitazone and/or Glimepiride are excreted in human milk. Because many drugs are excreted in human milk, combination of Pioglitazone and Glimepiride should not be administered to a nursing woman.
","General: Due to the mechanisms of action, Pioglitazone is active only in the presence of endogenous insulin. Therefore, combination of Pioglitazone and Glimepiride should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Hypoglycemia: All sulfonylurea drugs are capable of producing severe hypoglycemia. Proper patient selection, dosage, and instructions are important to avoid hypoglycemic episodes. Elderly patients are particularly susceptible to hypoglycemic action of glucose lowering drugs. Debilitated or malnourished patients and those with adrenal, pituitary, renal, or hepatic insufficiency are particularly susceptible to the hypoglycemic action of glucose lowering drugs.
Loss of Control of Blood Glucose: When a patient stabilized on any antidiabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, a temporary loss of glycemic control may occur. At such times, it may be necessary to withhold combination of Pioglitazone and Glimepiride and temporarily administer insulin. Combination of Pioglitazone and Glimepiride may be reinstituted after the acute episode is resolved.
Edema: Combination of Pioglitazone and Glimepiride should be used with caution in patients with edema. Since thiazolidinediones, including Pioglitazone can cause fluid retention, which can exacerbate or lead to congestive heart failure, combination of Pioglitazone and Glimepiride should be used with caution in patients at risk for heart failure.
Weight Gain: Dose-related weight gain was seen with Pioglitazone alone and in combination with other hypoglycemic agents. The mechanism of weight gain is unclear but probably involves a combination of fluid retention and fat accumulation.
Hepatic Effects: Liver enzymes should be checked prior to the initiation of therapy with combination of Pioglitazone and Glimepiride in all patients and periodically thereafter per the clinical judgment of the healthcare professional. Therapy with combination of Pioglitazone and Glimepiride should not be initiated in patients with increased baseline liver enzyme levels (ALT >2.5X upper limit of normal). If at any time ALT levels increase to >3X the upper limit of normal in patients on therapy with combination of Pioglitazone and Glimepiride, liver enzyme levels should be rechecked as soon as possible. If ALT levels remain >3X the upper limit of normal, therapy with combination of Pioglitazone and Glimepiride should be discontinued. If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, and anorexia, and/or dark urine, liver enzymes should be checked.
","Pediatric Uses: Safety and effectiveness of combination of Pioglitazone and Glimepiride in pediatric patients have not been established.
Geriatric use:
+
+- Pioglitazone: Results of the population pharmacokinetic analysis showed that age does not significantly affect the pharmacokinetics of Pioglitazone. Therefore, no dosage adjustments are required for the elderly.
+- Glimepiride: The drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
+
","Symptoms: Severe hypoglycaemia with coma, seizure, or neurological impairment.
Management: Admin glucagon or IV glucose. Additional carbohydrate intake may be necessary as hypoglycaemia may recur after apparent clinical recovery.
",,,"Store in a cool and dry place. Protect from light and moisture. Keep out of the reach of the children.
",12
+888,Pioglitazone,pioglitazone-888,https://medex.com.bd/attachments/KGHiHFuA7TZp3Wa1QOTk3auSTlu0nE/pioglitazone-prescribing-information,Thiazolidinedione Group,Type 2 DM,"Pioglitazone is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type II diabetes (NIDDM). Pioglitazone is indicated for monotherapy and also indicated for use in combination with sulphonylurea, Metformin or Insulin when diet and exercise plus the single agent does not result in adequate glycaemic control.
","Thiazolidinedione Group
","Pioglitazone is a preparation of Pioglitazone which is a member of the newest class of oral antidiabetic agent called thiazolidinediones. It depends on the presence of Insulin for its mechanism of action. Pioglitazone decreases Insulin resistance in the periphery and in the liver, resulting in increased Insulin dependent glucose disposal and decreased hepatic glucose output. It also improves abnormality in lipid metabolism by activating peroxisome proliferator activated receptor gamma (PPAR-γ).
","Pioglitazone can be taken once daily without regard to meals. The management of antidiabetic therapy should be individualized. Pioglitazone monotherapy may be initiated at 15 mg or 30 mg once daily dosages in patients not adequately controlled with diet and exercise alone. For patients who respond inadequately to the initial dose of Pioglitazone, the dose can be increased up to 45 mg once daily. For patients not responding adequately to monotherapy, combination therapy should be considered.
Maximum recommended daily dose of Pioglitazone should not exceed 45 mg since doses higher than 45 mg have not been studied in placebo controlled clinical studies. Besides, no placebo controlled clinical studies of more than 30 mg once daily have been conducted in combination therapy.
",,"Administration of thiazolidinediones with an oral contraceptive containing ethinyl oestradiol and norethindrone reduces the plasma concentration of both hormones by approximately 30% which could result in loss of contraception.
","Pioglitazone is contraindicated in patients with known hypersensitivity to any of its components.
","The overall incidence and types of adverse events reported in placebo controlled clinical trials of Pioglitazone monotherapy at doses of 7.5 mg, 15 mg, 30 mg or 45 mg once daily are upper respiratory tract infection (13.2%), headache (9.1%), sinusitis (6.3%), myalgia (5.4%), tooth disorder (5.3%), and pharyngitis (5.1%).
","Pregnancy: There are no adequate and well controlled studies in pregnant women. Pioglitazone should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Lactation: It is not known whether Pioglitazone is secreted in human milk. As many drugs are excreted in human milk, it should not be administered to a lactating women.
","Pioglitazone exerts its antihyperglycaemic effect only in the presence of Insulin. Therefore, it should not be used in Type 1 diabetes or for the treatment of diabetic ketoacidosis. Pioglitazone should be used with caution in case of combination antidiabetic therapy and hepatic insufficiency. Liver enzyme should be monitored regularly.
",,,,,"Store at 25° C.
",10
+887,Pimecrolimus,pimecrolimus-887,https://medex.com.bd/attachments/Syq8R2KQFY6TLKX7TX6gzLchFg7eOj/pimecrolimus-prescribing-information,Drugs affecting the immune response,Atopic dermatitis,"Pimecrolimus Cream is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription ... Read more
Pimecrolimus Cream is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable.
Pimecrolimus Cream is not indicated for use in children less than 2 years of age.
","Drugs affecting the immune response
","Pimecrolimus is a macrolactam and is a derivative of ascomycin. It is an immunosuppressant which inhibits the activation of T-cells and prevents the release of inflammatory mediators from mast cells. It is used for the short term or intermittent long term treatment for mild to moderate atopic eczema.
The mechanism of action of pimecrolimus in atopic dermatitis is not known. While the following have been observed, the clinical significance of these observations in atopic dermatitis is not known. It has been demonstrated that pimecrolimus binds with high affinity to macrophilin-12 (FKBP-12) and inhibits the calcium-dependent phosphatase, calcineurin. As a consequence, it inhibits T cell activation by blocking the transcription of early cytokines. In particular, pimecrolimus inhibits at nanomolar concentrations Interleukin-2 and interferon gamma (Th1-type) and Interleukin-4 and Interleukin-10 (Th2-type) cytokine synthesis in human T-cells. In addition, pimecrolimus prevents the release of inflammatory cytokines and mediators from mast cells in vitro after stimulation by antigen/IgE.
","Apply a thin layer of Pimecrolimus Cream, 1% to the affected skin twice daily. The patient should stop using Pimecrolimus Cream, 1% when signs and symptoms (e.g., itch, rash and redness) resolve and should be instructed on what actions to take if symptoms recur.
If signs and symptoms persist beyond 6 weeks, patients should be re-examined by their health care provider to confirm the diagnosis of atopic dermatitis.
Continuous long-term use of Pimecrolimus Cream, 1% should be avoided, and application should be limited to areas of involvement with atopic dermatitis
The safety of Pimecrolimus Cream, 1% under occlusion, which may promote systemic exposure, has not been evaluated. Avoid use of Pimecrolimus Cream, 1% with occlusive dressings.
",,"Potential interactions between Pimecrolimus Cream, 1% and other drugs, including immunizations, have not been systematically evaluated. Due to low blood levels of pimecrolimus detected in some patients after topical application, systemic drug interactions are not expected, but cannot be ruled out. The concomitant administration of known CYP3A family of inhibitors in patients with widespread and/or erythrodermic disease should be done with caution. Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine.
","Pimecrolimus Cream, 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream.
","Common side effects include headache, common cold or stuffy nose, sore throat, cough flu (influenza), fever, viral infection. Some people may get viral skin infections (like cold sores, chicken pox, shingles, or warts) or swollen lymph nodes (glands).
","Pregnancy Category C. There are no adequate and well-controlled studies with Pimecrolimus Cream, 1% in pregnant women. Therefore, Pimecrolimus Cream, 1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from pimecrolimus, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","
+- Should not be used in immunocompromised adults and children, including patients on systemic immunosuppressive medications.
+- Avoid treatment on malignant or pre-malignant skin conditions, as these can present as dermatitis.
+- Should not be used in patients with Netherton's Syndrome or skin diseases with a potential for increased systemic absorption.
+
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+1818,Pimavanserin,pimavanserin-1818,https://medex.com.bd/attachments/x2SgePrs2cdjTvwCOIWM53sJhQIMaL/pimavanserin-prescribing-information,Antiparkinson drugs,Parkinson’s disease,"Pimavanserin is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.
","Antiparkinson drugs
","The mechanism of action of pimavanserin in the treatment of hallucinations and delusions associated with Parkinson's disease psychosis is unknown. However, the effect of pimavanserin could be mediated through a combination of inverse agonist and antagonist activity at serotonin 5-HT 2A receptors and to a lesser extent at serotonin 5-HT2C receptors.
","The recommended dose of Pimavanserin is 34 mg, taken orally as two 17 mg strength tablets once daily, without titration. Pimavanserin can be taken with or without food.
",,"
+- Strong CYP3A4 Inhibitors (e.g., ketoconazole): Reduce Pimavanserin dose by one-half.
+- Strong CYP3A4 Inducers: Monitor for reduced efficacy. Increase in Pimavanserin dosage may be needed.
+
",,"Nausea, Constipation, Peripheral edema, Gait disturbance, Hallucination, Confusional state.
","There are no data on Pimavanserin use in pregnant women that would allow assessment of the drug-associated risk of major congenital malformations or miscarriage. There is no information regarding the presence of pimavanserin in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Pimavanserin and any potential adverse effects on the breastfed infant from Pimavanserin or from the underlying maternal condition.
","Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Antipsychotic drugs increase the all-cause risk of death in elderly patients with dementia-related psychosis. Analyses of 17 dementia-related psychosis placebo-controlled trials (modal duration of 10 weeks and largely in patients taking atypical antipsychotic drugs) revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in placebo-treated patients. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Pimavanserin is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis.
QT Interval Prolongation: Pimavanserin prolongs the QT interval. The use of Pimavanserin should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), certain antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and certain antibiotics (e.g., gatifloxacin, moxifloxacin). Pimavanserin should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval
","Pediatric Use: Safety and effectiveness of Pimavanserin have not been established in pediatric patients.
Geriatric Use: No dose adjustment is required for elderly patients.
Renal Impairment: No dosage adjustment for Pimavanserin is needed in patients with mild to moderate (CrCL ≥30 mL/min, Cockcroft-Gault) renal impairment.
Hepatic Impairment: Use of Pimavanserin is not recommended in patients with hepatic impairment. Pimavanserin has not been evaluated in this patient population.
",,,,"Store at 20°C to 25°C.
",10
+1344,Pilocarpine Hydrochloride (Oral),pilocarpine-hydrochloride-oral-1344,https://medex.com.bd/attachments/6XuKZtpXfd25Lc2rJjF6ELQQcikyL3/pilocarpine-hydrochloride-oral-prescribing-information,Drugs affecting exocrine secretions,Sjogren’s syndrome,"Pilocarpine is indicated for:
+
+- The treatment of symptoms of dry mouth from salivary gland dysfunction caused by radiotherapy for cancer of the head and neck.
+- The treatment of symptoms of dry mouth in patients with Sjogren’s syndrome.
+
","Drugs affecting exocrine secretions
","Pilocarpine is a cholinergic agonist exerting a broad spectrum of pharmacologic effects with predominant muscarinic action. Pilocarpine, in appropriate dosage, can increase secretion by the exocrine glands such as sweat, salivary, lacrimal, gastric, pancreatic, and intestinal glands and the mucous cells of the respiratory tract. The tone and motility of urinary tract, gallbladder and biliary duct, smooth muscle may be enhanced.
","For Head & Neck Cancer Patients: The recommended initial dose of pilocarpine hydrochloride tablets is one tablet taken three times a day. Dosage should be titrated according to therapeutic response and tolerance. The maximum daily dose is 30 mg daily (Not to exceed 10 mg per dose). Therapy should be discontinued if no improvement is noted after 2-3 months of therapy.
For Sjogren’s syndrome: The recommended dose of Pilocarpine HCl tablets is one tablet (5 mg) four times a day. Efficacy was established by 6 weeks of use.
Pilocarpine tablet should be taken with a glass of water during or directly after meals. The last tablet should always be taken in conjunction with evening meal.Regardless of the indication, the starting dose in patients with moderate hepatic impairment should be one tablet twice daily, followed by adjustment based on therapeutic response and tolerability. Patients with mild hepatic insufficiency do not require dosage reductions.
",,"Pilocarpine should be administered with caution to patients taking beta adrenergic antagonists because of the possibility of conduction disturbances. Pilocarpine might antagonize the anticholinergic effects of drugs used concomitantly.
","Pilocarpine is contraindicated in patients with uncontrolled asthma, cardiovascular disease, known hypersensitivity to pilocarpine and when miosis is undesirable, e.g. in acute iritis and in narrow-angle (angle closure) glaucoma.
","Headache, visual disturbance, lacrimation, sweating, respiratory distress, gastrointestinal spasm, nausea, vomiting, diarrhea, atrioventricular block, tachycardia, bradycardia, hypotension, hypertension, shock, mental confusion, cardiac arrhythmia, and tremors etc may occur. Most of the adverse experiences observed during pilocarpine treatment were consequences of exaggerated parasympathetic stimulation. These adverse experiences were dose-dependent and usually mild and self-limited.
",,"Pilocarpine should be administered with caution to patients with known or suspected cholelithiasis or biliary tract disease. If a patients sweats excessively while taking pilocarpine hydrochloride and can not drink enough liquid, the patient should consult a physician.
","Use in pregnancy: Pregnancy Category C. There is no adequate and well controlled studies in pregnant women. Pilocarpine HCl should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.
Use in nursing mother: It is not known whether the drug is excreted in human milk. However, decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Use in children: Safety and effectiveness in pediatric patients have not been established.
",,,,,9
+886,Pilocarpine Hydrochloride (Ophthalmic),pilocarpine-hydrochloride-ophthalmic-886,,Drugs affecting exocrine secretions,Suspected glaucoma,"Pilocarpine is indicated for chronic open angle glaucoma, acute or chronic narrow angle glaucoma, suspected glaucoma and ocular hypertension.
","Drugs affecting exocrine secretions
","Pilocarpine Hydrochloride directly stimulates cholinergic receptors. It produces contraction of the iris sphincter muscle, resulting in pupillary constriction (miosis); constriction of the ciliary muscle, resulting in increased accommodation; and reduction in intraocular pressure associated with an increase in the outflow and a decrease in the inflow of aqueous humor. In chronic open angle glaucoma, the exact mechanism by which miotics lower intraocular pressure is not exactly known; however, contraction of the ciliary muscle apparently opens the intertrabecular spaces and facilitates aqueous humor outflow. There is also a decrease in the rate of inflow of aqueous humor. In angle-closure glaucoma, constriction of the pupil apparently pulls the iris away from the trabeculum, thereby relieving blockage of the trabecular meshwork.
","Instill 1 drop 2-4 times daily. To minimize systemic absorption of the active ingredient of the eye drops, pressure should be applied for one minute on the tear duct after application.
",,"Belladonna alkaloids or cyclopentolate used ophthalmically may interfere with the miotic effects of pilocarpine and may have their own mydriatic effects dampened. This latter may be used to therapeutic advantage.
","Hypersensitivity to any ingredient including excipients. Conditions where pupillary constriction is undesirable (e.g. acute iritis). Retinal detachment; past history of retinal detachment or conditions that predispose to retinal detachment.
","Common: Temporary blurred vision, burning, stinging, redness, watering of the eyes, decrease in night vision, eye irritation, headache.
Rare: Eye pain, increased sweating, muscle tremors, nausea, vomiting, diarrhea, watering of the mouth, troubled breathing or wheezing.
","Safe use during pregnancy has not been established. Problems in human pregnancy have not been documented. However, ophthalmic Pilocarpine is systemically absorbed.
","If blurred vision or changes in near or far sight occur, especially at night, patients should exercise caution when involved in night driving or hazardous work in poor light. It is recommended that intraocular pressure measurements be performed regularly during therapy.
",,"Dilution with water and other fluids is the usual response to accidental or deliberate overdose.
",,,"Store at room temperature and protect from light. It is desirable that the contents should not be used more than 4 weeks after first opening of the bottle.
",11
+1626,Phytomenadione (Oral),phytomenadione-oral-1626,https://medex.com.bd/attachments/VbDzTMq5KI9NVDTcaBNHQO4D8aener/phytomenadione-oral-prescribing-information,Vitamin-K Preparations,Vitamin K deficiency,"Phytomenadione is indicated for the prevention of Vitamin K Deficiency Bleeding (VKDB) in newborn babies.
","Vitamin-K Preparations
","Vitamin K1 is an essential co-factor in the hepatic synthesis of prothrombin (factor II) and other blood clotting factors (factor VII, IX, X). Vitamin K1 does not readily cross the placenta barrier from mother to child and is poorly excreted in breast milk. Low levels at birth may lead to the development of the hemorrhagic disease of the newborn (HDN). Administration of Phytomenadione promotes the synthesis of essential coagulation factors in the liver and minimizes the risk of Vitamin K1 Deficiency Bleeding (VKDB). After oral administration of Phytomenadione, it is absorbed from small intestine and taken up by the liver, even in the absence of biliary and pancreatic secretions. Its plasma half-life is 2-3 hours.
","The contents of Vitamin K1 capsule should be administered by cutting the narrow tubular tip off the capsule and squeezing the liquid into the baby’s mouth.
+
+- One Vitamin K1 (1 mg) capsule is to be administered at birth and another dose should be given if the first dose is spat out.
+- For babies who are being exclusively breastfed, a dose of 1 mg once weekly for 12 weeks is recommended for the prevention of late Vitamin K Deficiency Bleeding.
+
",,"Vitamin K1 acts as an antidote to the anticoagulant drugs of the coumarin type, therefore concomitant use is not recommended except in the treatment of warfarin overdosage. It is not an antidote to heparin.
","Further doses of Vitamin K1 soft gelatin capsules should be avoided to any baby showing evidence of hypersensitivity to any of the constituents of the product.
","No adverse effects have been associated with oral administration.
","Not relevant.
","Before giving Vitamin K1, physicians' advice should be taken for babies currently on treatment with warfarin for protein C or protein S deficiency.
",,,,,"Store in a cool and dry place. Protect from light and keep out of reach of children. Do not freeze.
",10
+885,Phytomenadione (Injection),phytomenadione-injection-885,https://medex.com.bd/attachments/JykYNigD9fQwbTEfxfwBlY38XdO4dC/phytomenadione-injection-injection-prescribing-information,Vitamin-K Preparations,Vitamin K deficiency,"Phytomenadione (Vitamin K-1) is indicated in following indications-
+
+- Prophylaxis and treatment of haemorrhagic disease in the newborn.
+- Haemorrhage or risk of haemorrhage as a result of severe hypoprothrombinemia (i.e. deficiency of clotting factors II, VII, IX and X) of various etiologies, including overdosage of courmarin-type anticoagulants, their combination with phenylbutazone, and other forms of hypovitaminosis K (e.g. in obstructive jaundice as well as liver and intestinal disorders, and after prolonged treatment with antibiotics, sulphonamides or salicylates).
+- Prevention and treatment of bleeding due to vitamin K deficiency.
+
","Vitamin-K Preparations
","Phytomenadione is a procoagulant factor. As a component of a hepatic carboxylase system, Phytomenadione is involved in the post translational carboxylation of clotting factors II (prothrombin), VII, IX and X and the clotting inhibitors protein C and protein S. Phytomenadione is ineffective in hereditary hypoprothrombinemia or hypoprothrombinemia induced by severe hepatic failure. Lack of Phytomenadione leads to an increased tendency to haemorrhagic disease in the newborn. Phytomenadione administration, which promotes synthesis of the above-mentioned coagulation factors by the liver, can reverse an abnormal coagulation status and bleeding due to Phytomenadione deficiency.
","Prophylaxis: Mild Hemorrhage or hemorrhagic tendency: The usual dose for Neonates is 2 mg orally at or just after birth. Then 2 mg on 4
th-5
th day and another 2 mg on 28
th-30
th day orally. If the oral route is unsuitable then 2 mg of drug can be administered by IM or IV route.
Children over 1 year of age: Could be given 5-10 mg orally. A single 1 mg (0.1 ml) dose IM is recommended in children who are not assured of receiving a second oral dose or, in the case of breast-fed children, who are not assured of receiving a third oral dose.
Therapy: Initially, 1 mg by intravenous injection, with further doses as required, based on the clinical picture and coagulation status.
Neonates with special risk factors: Pre-maturity, birth asphyxia (inadequate intake of oxygen by the baby during birth process), obstructive jaundice, inability to swallow, maternal use of anticoagulants or anti-epileptics-
+
+- 1 mg intramuscularly or intravenously at birth or shortly after birth if the oral route is unsuitable.
+- Intramuscular and intravenous doses should not exceed 0.4 mg/kg in premature infants weighing less than 2.5 kg.
+- The size and frequency of further doses should be based on coagulation status
+
+To ensure a total protection of the newborns, 3 prophylactic doses of Vitamin K should be administered orally following the dosing schedule mentioned above.
",,"Phytomenadione antagonises the effect of coumarin-type anticoagulants. Coadministration of anticonvulsants can impair the action of vitamin K-1.
","It is contraindicated in patients with known hypersensitivity to any of its constituents.
","There are isolated unconfirmed reports on the possible occurrence of anaphylactoid reactions and venous irritation or phlebitis after parenteral use of Phytomenadione injections.
",,"Careful monitoring of the coagulation parameters is necessary for patients with severely impaired liver function after administration of Phytomenadione .
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+884,Phospholipids,phospholipids-884,,"Cholagogues, Cholelitholytics & Hepatic Protectors",,"Phospholipids is indicated for prevention and treatment of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants.
Prevention: In premature infants less than 1250 g birthweight, or with evidence of surfactant deficiency, give Phospholipids ... Read more
Phospholipids is indicated for prevention and treatment of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants.
Prevention: In premature infants less than 1250 g birthweight, or with evidence of surfactant deficiency, give Phospholipids as soon as possible, preferably within 15 minutes of birth.
Rescue: To treat infants with RDS confirmed by X-ray and requiring mechanical ventilation, give Phospholipids as soon as possible, preferably by 8 hours of age.
Results from clinical studies suggest that little benefit is likely to be gained from giving Phospholipids to infants who have completed a prenatal course of corticosteroids, unless they develop RDS within the first 6-8 hours of life.
The results of outborn compared to inborn infants were not analysed separately in the clinical trials.Outborn infants were distributed equally between the treatment groups and were not considered likely to bias the estimation of treatment effect. Therefore, there does not appear to be any evidence to suggest that outborn infants respond less well to treatment with Phospholipids.
","Cholagogues, Cholelitholytics & Hepatic Protectors, Pulmonary surfactants
","Endogenous pulmonary surfactant lowers surface tension on alveolar surfaces during respiration and stabilizes the alveoli against collapse at resting transpulmonary pressures. Deficiency of pulmonary surfactant causes Respiratory Distress Syndrome (RDS) in premature infants. Phospholipid replenishes surfactant and restores surface activity to the lungs of these infants.
In vitro, Phospholipid reproducibly lowers minimum surface tension to less than 8 dynes/cm on the pulsating bubble surfactometer and Wilhelmy Surface Balance.
In vivo, single Phospholipid doses improve lung pressure-volume measurements, lung compliance, and oxygenation in premature rabbit and sheep.
","For Intratracheal Administration Only. Survanta should be administered by or under the supervision of clinicians experienced in intubation, ventilator management and general care of premature infants.
Marked improvements in oxygenation may occur within minutes of administration of Survanta. Therefore, frequent and careful clinical observation and monitoring of systemic oxygenation are essential to avoid hyperoxia.
Each dose of Survanta is 100 mg of phospholipid/kg birth weight (4 mL/kg). The Survanta Dosage Chart shows the total dosage for a range of birth weights.
Four doses of Survanta can be administered in the first 48 hours of life. Doses should be given no more frequently than every 6 hours.
","Directions for Use: Phospholipid should be inspected visually for discolouration prior to administration. The colour of Phospholipid is off-white to light brown. If settling occurs during storage, swirl the vial gently (DO NOT SHAKE) to redisperse. Some foaming at the surface may occur during handling and is inherent in the nature of the product.
Phospholipids is stored refrigerated (2-8°C). Before administration, Phospholipids should be warmed by standing at room temperature for at least 20 minutes or warmed in the hand for at least 8 minutes. If a prevention dose is to be given, preparation of Phospholipids should begin before the infant’s birth.
Unopened, unused vials of Phospholipids that have been warmed to room temperature may be returned to the refrigerator within 8 hours of warming and stored for future use. Drug should not be warmed and returned to the refrigerator more than once. Each single-use vial of Phospholipids should be entered only once. Used vials with residual drug should be discarded.
Dosing Precautions: If an infant experiences bradycardia or oxygen desaturation during the dosing procedure, stop the dosing procedure and initiate appropriate measures to alleviate the condition. After the infant has stabilised, resume the dosing procedure. Rales and moist breath sounds can occur transiently after administration of Phospholipids. Endotracheal suctioning or other remedial action is unnecessary unless clear-cut signs of airway obstruction are present.
Methods of Administration:
+
+- Method A outlined below was the original method of administration in all the controlled clinical studies that established the efficacy and safety of Phospholipid. The two additional methods of administering Phospholipid were compared to the original method in a multi-centre, randomised clinical trial involving 299 infants weighing 600g or more with RDS requiring mechanical ventilation. There were no significant differences among the three methods in average FiO2 a/A PO2 or MAP at 72 hours of age, or in the incidence of pulmonary air leaks, pulmonary interstitial emphysema, patent ductus arteriosus, or mortality at 72 hours of age.
+- Method B keeping the infant on the ventilator is considered the delivery method of choice as it was associated with less clinical deterioration (expressed as falls in heart rate and in oxygen saturation) during and immediately following treatment. Method B was associated with a greater degree of Phospholipid reflux than the other methods. This reflux was not associated with any clinical consequence.
+- Method C: Phospholipids can be administered by inserting the 5 French catheter through the endotracheal tube while the endotracheal tube is briefly disconnected from the ventilator. The half doses were administered in the two positions described as for Method B. The procedure for dosing is similar to Method A, the only difference being the use of two half doses instead of four quarter doses. With the infant supine, the head and body of the infant were turned approximately 45° to the right. The infant is removed from the ventilator and the primed catheter inserted into the endotracheal tube. The first half of the Phospholipids is then delivered and the catheter withdrawn. The infant is then returned to the ventilator for at least 30 seconds of mechanical ventilation. The head and body of the infant is turned approximately 45° to the left. The second half dose of Phospholipids is delivered in the same manner as the first. The catheter is withdrawn and the infant returned to mechanical ventilation.
+
",,,"
+- Respiratory: lung consolidation, blood from the endotracheal tube, deterioration after weaning, respiratory decompensation, subglottic stenosis, paralyzed diaphragm, respiratory failure.
+- Cardiovascular: hypotension, hypertension, tachycardia, ventricular tachycardia, aortic thrombosis, cardiac failure, cardio-respiratory arrest, increased apical pulse, persistent foetal circulation, air embolism, total anomalous pulmonary venous return.
+- Gastrointestinal: abdominal distension, haemorrhage, intestinal perforations, volvulus, bowel infarct, loading intolerance, hepatic failure, stress ulcer.
+- Renal: renal failure, haematuria.
+- Haematologic: coagulopathy, thrombocytopenia, disseminated intravascular coagulation
+- Central Nervous System: seizures.
+- Endocrine/Metabolic: adrenal haemorrhage, inappropriate ADH secretion, hyperphosphataemia.
+- Musculoskeletal: inguinal hernia.
+- Systemic: fever, deterioration.
+
",,"Phospholipids are intended for intratracheal use only. Phospholipids can rapidly affect oxygenation and lung compliance. Therefore, its use should be restricted to a highly supervised clinical setting with immediate availability of clinicians experienced with intubation, ventilator management and general care of premature infants. Infants receiving Phospholipids should be frequently monitored with arterial or transcutaneous measurement of systemic oxygen and carbon dioxide.
During the dosing procedure, transient episodes of bradycardia and decreased oxygen saturation have been reported. If these occur, stop the dosing procedure and initiate appropriate measures to alleviate the condition. After stabilization, resume the dosing procedure.
General: Rales and moist breath sounds can occur transiently after administration. Endotracheal suctioning or other remedial action is not necessary unless clear-cut signs of airway obstruction are present.
Increased probability of post-treatment nosocomial sepsis in Phospholipids-treated infants was observed in the controlled clinical trials (See Table). The increased risk for sepsis among Phospholipids-treated infants was not associated with increased mortality among these infants. The causative organisms were similar in treated and control infants. There was no significant difference between groups in the rate of post-treatment infections other than sepsis.
Use of Phospholipids in infants less than 600 g birth weight or greater than 1750 g birth weight has not been evaluated in controlled trials. There is no controlled experience with use of Phospholipids in conjunction with experimental therapies for RDS (eg. high-frequency ventilation or extracorporeal membrane oxygenation).
No information is available on the effects of doses other than 100 mg Phospholipidss / kg, more than four doses, dosing more frequently than every 6 hours, or administration after 48 hours of age.
",,"Overdosage with Phospholipids has not been reported. Based on animal data, overdosage might result in acute airway obstruction. Treatment should be symptomatic and supportive. Rales and moist breath sounds can transiently occur after Phospholipids is given, and do not indicate overdosage. Endotracheal suctioning or other remedial action is not required unless clear-cut signs of airway obstruction are present.
",,,"Store unopened vials at refrigeration temperature (2-8°C). Protect from light. Store vials in carton until ready for use. Vials are for single use only. Upon opening, discard unused drug.
",9
+1268,Pholcodine,pholcodine-1268,,Cough suppressant,Nonproductive coughs,"Pholcodine is indicated as a cough suppressant for the temporary relief of non-productive dry cough. It is stated to present a required label indication of ""temporary relief of dry cough"". Cough is the respiratory movement that occurs after an irritation signal is transmitted to the central nervous ... Read more
Pholcodine is indicated as a cough suppressant for the temporary relief of non-productive dry cough. It is stated to present a required label indication of ""temporary relief of dry cough"". Cough is the respiratory movement that occurs after an irritation signal is transmitted to the central nervous system and further stimulates the medulla oblongata. This stimulation causes a motor output that is sent through motoneurons to the respiratory muscles. A non-productive cough is a type of cough characterized by the absence of sputum, and it has a large inspiration that will cause continuous coughing.
","Cough suppressant
","Pholcodine is an anti-tussive agent that acts primarily on the CNS, causing depression of the cough reflex. It has mild sedative effect with little or no analgesic action.
","Adult:
+
+- Symptomatic relief of non-productive cough: 5-10 mg 3-4 times daily.
+
+Child:
+
+- 12-18 year: 5-10 mg 3-4 times daily.
+- 6-12 year: 2-5 mg 3-4 times daily.
+- Children under the age of 6 year: Not to be used
+
","May be taken with or without food.
","Not to be used with MAOI or within 14 days of stopping treatment. May enhance sedative effect of alcohol and other CNS depressants e.g. sedatives, hypnotics, barbiturates, narcotic analgesics, phenothiazines, tricyclic antidepressants. Hypotensive effect may be enhanced when used with antihypertensive agents and diuretics. Interaction with neuromuscular blocking agent has been reported.
","Patients in, or at risk of developing respiratory failure. Chronic bronchitis, COPD, bronchiolitis, and bronchiectasis due to sputum retention. Concurrent or recent use (within preedicing 14 days) of MAOIs. Children <6 yr
","Dizziness, occasional drowsiness, nausea, vomiting, constipation, rash, sputum retention, excitation, confusion, ataxia.
","Category not classified
","Renal and/or hepatic impairment. Caution in patients with impaired respiratory function and asthma. May cause occasional drowsiness, caution when driving or operating machinery. Pregnancy and lactation.
",,"Symptoms: Drowsiness, nausea, restlessness, excitement, ataxia and respiratory depression.
Management: Provide symptomatic and supportive treatment. Maintain respiration; may use activated charcoal or gastric lavage to remove the ingested Pholcodine. In cases of severe overdosage, naloxone may be given to reverse the central and peripheral opioid effects.
",,,"Store below 25° C.
",12
+883,Phenytoin Sodium,phenytoin-sodium-883,https://medex.com.bd/attachments/4N9kRdGIW5NpRg8kdg211PisJmOLij/phenytoin-sodium-oral-suspension-prescribing-information,Adjunct anti-epileptic drugs,Tonic-clonic status epilepticus,"Parenteral Phenytoin is indicated for the treatment of generalized tonic-clonic status epilepticus, and prevention and treatment of seizures occurring during neurosurgery. Intravenous Phenytoin can also be substituted, as short-term use, for oral phenytoin. Parenteral Phenytoin should be used only when oral Phenytoin administration is not possible
","Adjunct anti-epileptic drugs
","Phenytoin acts as an anticonvulsant by increasing efflux or decreasing influx of sodium ions across cell membranes in the motor cortex during generation of nerve impulses; thus stabilising neuronal membranes and decreasing seizure activity. It acts as an antiarrhythmic by extending the effective refractory period and suppressing ventricular pacemaker automaticity, shortening action potential in the heart.
","Oral: Epilepsy:
+
+- Adult: Initially, 3-4 mg/kg daily as single dose or in divided doses. Alternatively, 150-300 mg daily increased gradually to 600 mg daily if necessary. Maintenance: 200-500 mg daily.
+- Child: Initially, 5 mg/kg daily in 2-3 divided doses. Maintenance: 4-8 mg/kg daily in divided doses. Max dose: 300 mg daily.
+
+
Intravenous: Tonic-clonic status epilepticus:
+
+- Adult: Adjunctive therapy with a benzodiazepine (e.g. diazepam): 10-15 mg/kg by slow inj or intermittent infusion at a max rate of 50 mg/min. Maintenance: 100 mg IV (or orally) given every 6-8 hr.
+- Child: Neonates: 20 mg/kg as a loading dose, then 2.5-5 mg/kg bid; 1 mth-12 yr: 18 mg/kg as a loading dose, then 2.5-5 mg/kg bid; >12 yr: 18 mg/kg as a loading dose, then up to 100 mg 3-4 times daily.
+
","Should be taken with food. When administering to patients on nasogastric or other enteral feeds, do not administer feeds 2 hr before or after a dose. Be consistent throughout therapy in relation to feed times. Do not switch dosage forms/brands w/o prior consideration.
","Effects with other sedative drugs or ethanol may be potentiated. Enhances toxic effects of paracetamol, lithium. Increased risk of osteomalacia with acetazolamide. Decreased serum levels/effects with acyclovir, antineoplastics, benzodiazeines, ciprofloxacin, CYP2C9 inducers (e.g. carbamazepine), CYP2C19 inducers (e.g. rifampin), folic acid, vigabatrin. Increased serum concentrations with allopurinol, capecitabine, cimetidine, CYP2C9 inhibitors (e.g. fluconazole), CYP2C19 inhibitors (e.g. delavirdine), disulfiram, methylphenidate, metronidazole, omeprazole, SSRI, trazodone, trimethoprim. Increases metabolism of antiarrhythmics, anticonvulsants, antipsychotics, beta-blockers, calcium channel blockers, chloramphenicol, corticosteroids, doxycycline, oestrogens, HMG-CoA reductase inhibitors, methadone, theophylline, TCAs. Decreases levels/effects of clozapine, ciclosporin, tacrolimus, CYP2B6 substrates (e.g. bupropion, selegiline), CYP2C8 substrates (e.g. amiodarone), CYP2C9 substrates (e.g. celecoxib), CYP2C19 substrates (e.g. citalopram), CYP3A4 substrates (e.g. benzodiazepines), digoxin, itraconazole, levodopa, neuromuscular-blocking agents, thyroid hormones, topiramate. Increases levels/effect of dopamine, ticlopidine. Valproic acid may displace phenytoin from binding sites; and affect phenytoin serum concentrations. Transiently increases the hypothrombinaemia response to warfarin initially, followed by an inhibition of the response.
","Phenytoin Sodium is contraindicated in patients with:
+
+- A history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins
+- Sinus bradycardia, sino-atrial block, second and third degree A-V block, and Adams-Stokes syndrome because of the effect of parenteral phenytoin on ventricular automaticity.
+- A history of prior acute hepatotoxicity attributable to phenytoin
+- Coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors.
+
","Hypersensitivity, lack of appetite, headache, dizziness, tremor, transient nervousness, insomnia, GI disturbances (e.g. nausea, vomiting, constipation), tenderness and hyperplasia of the gums, acne, hirsutism, coarsening of the facial features, rashes, osteomalacia. Phenytoin toxicity as manifested as a syndrome of cerebellar, vestibular, ocular effects, notably nystagmus, diplopia, slurred speech, and ataxia; also with mental confusion, dyskinesias, exacerbations of seizure frequency, hyperglycaemia. Solutions for inj may cause local irritation or phlebitis. Prolonged use may produce subtle effects on mental function and cognition, especially in children.
","Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Cardiovascular disease, e.g. sinus bradycardia, heart blocks; DM; hepatic impairment; hypoalbuminemia; porphyria; seizures (may increase frequency of petit mal seizures); debilitated patients; elderly. Caution in IV admin in hypotension, heart failure or MI, monitor BP and ECG during therapy. IV must be given slowly (too rapid admin may cause hypotension, CNS depression, cardiac arrhythmias and impaired heart conduction). Extravasation and intra-arterial admin must be avoided. Do not discontinue abruptly (may increase seizure frequency), unless safety concerns require a more rapid withdrawal. May impair ability to drive or operate machinery.
","Pediatric Use: A loading dose of 15 to 20 mg/kg of Phenytoin intravenously will usually produce serum concentrations of phenytoin within the generally accepted serum total concentrations between 10 and 20 mcg/mL (unbound phenytoin concentrations of 1 to 2 mcg/mL). Because of the increased risk of adverse cardiovascular reactions associated with rapid administration Phenytoin should be injected slowly intravenously at a rate not exceeding 1 to 3 mg/kg/min or 50 mg per minute, whichever is slower
Geriatric Use: Phenytoin clearance tends to decrease with increasing age. Lower or less frequent dosing may be required
Renal and Hepatic Impairment Or Hypoalbuminemia: The liver is the site of biotransformation. Patients with impaired liver function, elderly patients, or those who are gravely ill may show early toxicity. Because the fraction of unbound phenytoin is increased in patients with renal or hepatic disease, or in those with hypoalbuminemia, the monitoring of phenytoin serum levels should be based on the unbound fraction in those patients.
","The lethal dose in pediatric patients is not known. The lethal dose in adults is estimated to be 2 to 5 grams. The initial symptoms are nystagmus, ataxia, and dysarthria. Other signs are tremor, hyperreflexia, lethargy, slurred speech, blurred vision, nausea, and vomiting. The patient may become comatose and hypotensive. Death is caused by respiratory and circulatory depression.
There are marked variations among individuals with respect to phenytoin serum levels where toxicity may occur. Nystagmus, on lateral gaze, usually appears at 20 mcg/mL, ataxia at 30 mcg/mL, dysarthria and lethargy appear when the serum concentration is over 40 mcg/mL, but as high a concentration as 50 mcg/mL has been reported without evidence of toxicity. As much as 25 times the therapeutic dose has been taken to result in a serum concentration over 100 mcg/mL with complete recovery. Irreversible cerebellar dysfunction and atrophy have been reported.
Treatment: Treatment is nonspecific since there is no known antidote. The adequacy of the respiratory and circulatory systems should be carefully observed and appropriate supportive measures employed. Hemodialysis can be considered since phenytoin is not completely bound to plasma proteins. Total exchange transfusion has been used in the treatment of severe intoxication in pediatric patients. In acute overdosage the possibility of other CNS depressants, including alcohol, should be borne in mind.
",,,"Intravenous: Store at room temperature of 15-30°C.
Oral:
+
+- Tablet/capsule: Store below 30°C. Protect from light and moisture;
+- Oral suspension: Store at room temperature of 20-25°C, do not freeze, protect from light.
+
",13
+918,Prednisolone,prednisolone-918,https://medex.com.bd/attachments/G4Fxt3RavP6sg3sxJHDaj91XjBi5bw/prednisolone-oral-solution-prescribing-information,Glucocorticoids,Wiskott-Aldrich syndrome,"Rheumatic Disorders: Psoriatic arthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis.
Endocrine Disorders: ... Read more
Rheumatic Disorders: Psoriatic arthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis.
Endocrine Disorders: Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcemia associated with cancer.
Dermatologic Diseases: Pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme, exfoliative dermatitis, mycosis fungoides, severe psoriasis.
Allergic States: Seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity reactions.
Respiratory Diseases: Symptomatic sarcoidosis, berylliosis, fulminating, aspiration pneumonitis.
Hematologic Disorders: Idiopathic thrombocytopenic purpura, secondary thrombocytopenia, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia).
Edematous States: To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.
Gastrointestinal Diseases: Ulcerative colitis, regional enteritis.
","Glucocorticoids
","Prednisolone is a synthetic adrenocortical drug with predominantly glucocorticoid properties. Prednisolone directly inhibits the action of the Phospholipase A2 enzyme which is responsible for the production of different inflammatory mediators like Leukotrienes, SRS-A, Prostaglandins etc. Prednisolone is rapidly and well absorbed from the Gl tract following oral administration. Prednisolone is 70- 90% protein-bound in the plasma and it is eliminated from the plasma with a half-life of 2 to 4 hours. It is metabolized mainly in the liver and excreted in the urine.
","Adult-
Nephrotic Syndrome:
+
+- Initial: 2 mg/kg/day (maximum 80 mg/day) in divided doses 3 to 4 times/day until urine is protein free for 3 consecutive days (maximum: 28 days); followed by 1 to 1.5 mg/kg/dose given every other day for 4 weeks.
+- Maintenance dose: 0.5 to 1 mg/kg/ dose given every other day for 3 to 6 months.
+
+
Anti-inflammatory: 5 to 60 mg per day in divided doses 1 to 4 times/day.
Acute Asthma: 40-60 mg/day PO in single daily dose or divided q12 hr for 3-10 days.
Allergic Conditions:
+
+- Day 1: 10 mg PO before breakfast, 5 mg after lunch and after dinner, and 10 mg at bedtime.
+- Day 2: 5 mg PO before breakfast, after lunch, and after dinner and 10 mg at bedtime.
+- Day 3: 5 mg PO before breakfast, after lunch, after dinner, and at bedtime.
+- Day 4: 5 mg PO before breakfast, after lunch, and at bedtime.
+- Day 5: 5 mg PO before breakfast and at bedtime.
+- Day 6: 5 mg PO before breakfast.
+
+
Pediatric-
Asthma:
+
+- 1 year: Acute: 10 mg orally every 12 hours. Maintenance: 10 mg orally every other day.
+- 1 to 4 years: Acute: 20 mg orally every 12 hours. Maintenance: 20 mg orally every other day.
+- 5 to 12 years: Acute: 30 mg orally every 12 hours. Maintenance: 30 mg orally every other day.
+- 12 years: Acute: 40 mg orally every 12 hours. Maintenance: 40 mg orally every other day.
+
+
Anti-inflammatory: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.
Immunosuppression: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.
",,"The efficacy of prednisolone is reduced by Aminoglutethimide, Antacids, Barbiturates, Carbamazepine, Griseofulvin, Mitotane, Phenylbutazone, Phenytoin, Primidone and Rifampin. Prednisolone reduces the amount of potassium in the blood. Digitalis can cause Cardiac arrhythmias if hypokalemia occurs. Immunization should be done very carefully.
","Systemic infections unless specific anti-infective therapy is employed. Hypersensitivity to any ingredient. Ocular herpes simplex because of possible perforation.
","Common side effects include increased appetite, indigestion, nervousness or restlessness. Less frequent or rare side effects are darkening or lightening of skin color, dizziness or lightheadedness, flushing of face or cheeks, hiccups, increased sweating, the sensation of spinning.
","This medicine is not recommended for use during pregnancy unless considered essential by your doctor. It should only be used if the expected benefit to the mother is greater than any possible risk to the foetus. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production or cause other unwanted effects.
","Precaution has to be taken in diabetes, hypertension, Psychological disturbances, osteoporosis, post-menopausal women, pregnancy and in chronic nephritis. Long-term use of Prednisolone can cause Cushing's habitus, hyperglycemia, muscular weakness, increased susceptibility to infection, delayed wound healing, and psychiatric disturbances.
",,"Adverse effects related to prednisone normally develop only after prolonged use of doses in excess of the normal physiological requirement. Treatment is symptomatic and where possible the prednisone dose should be reduced gradually.
",,,"Store in a cool and dry place, protected from light. Keep out of the reach of the children.
",11
+914,Precipitated Sulpher + Salicylic Acid,precipitated-sulpher-salicylic-acid-914,,Other scalp preparations,Warts,"Salicylic acid and sulfur combination is used to treat acne and other skin disorders and dandruff and other scalp disorders, such as seborrheic dermatitis.
","Local Antipruritic, Other scalp preparations
","Salicylic acid is a potent keratolytic with mild antiseptic action when applied topically. Sulfur topical is a scabicide and keratolytic agent.
The mechanism of action when these two ingredients are combined, may be a synergistic keratolytic effect. The mechanism of action of salicylic acid in the treatment of acne may also include anti-inflammatory activity.
","The dose of salicylic acid and sulfur will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of salicylic acid and sulfur. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
+
For acne or oily skin-
+Bar dosage form:
+
+- Adults and children: Use on the affected skin two or three times a day.
+
+Cleansing lotion dosage form:
+
+- Adults and children: Use on wet skin one to three times a day. Rub lather into skin for one minute then rinse.
+
+
For dandruff and seborrheic dermatitis of the scalp-
+Bar and shampoo dosage forms:
+
+- Adults and children: Use on the scalp once a day at least two times a week or as directed by doctor. May be used each day if needed.
+
","Use salicylic acid and sulfur only as directed. Do not use more of it and do not use it more often than recommended on the label, unless otherwise directed by your doctor. Immediately after using salicylic acid and sulfur, wash your hands to remove any medicine that may be on them. Keep salicylic acid and sulfur away from the eyes. If you should accidentally get some in your eyes, flush them thoroughly with water.
To use the skin cleansing lotion: After wetting the skin, apply salicylic acid and sulfur with your fingertips or a wet sponge and rub in gently to work up a lather. Then rinse thoroughly and pat dry.
To use the shampoo or bar as a shampoo: Wet the hair and scalp with lukewarm water. Then apply enough medicine to work up a lather and rub into the scalp. Continue rubbing the lather into the scalp for several minutes or allow it to remain on the scalp for about 5 minutes, depending on the product being used, then rinse. Apply the medicine again and rinse thoroughly.
To use the bar as a soap: After wetting the skin, use salicylic acid and sulfur to wash the face and other affected areas. Then rinse thoroughly and pat dry.
","Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
","Hyppersensitivity.
","Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur: Skin irritation not present before use of salicylic acid and sulfur
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
+
+- Redness and peeling of skin (may occur after a few days)
+- unusual dryness of skin
+
","Breast Feeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
","When using salicylic acid and sulfur combination medicine, do not use any of the following preparations on the same affected area as salicylic acid and sulfur, unless otherwise directed by your doctor:
+
+- Abrasive soaps or cleansers
+- Alcohol-containing preparations
+- Any other topical acne preparation or preparation containing a peeling agent (for example, benzoyl peroxide, resorcinol, or tretinoin [vitamin A acid])
+- Cosmetics or soaps that dry the skin
+- Medicated cosmetics
+- Other topical medicine for the skin
+
+To use any of the above preparations on the same affected area as salicylic acid and sulfur combination medicine may cause severe irritation of the skin.
Do not use any topical mercury-containing preparation, such as ammoniated mercury ointment, on the same affected area as salicylic acid and sulfur . To do so may cause a foul odor, may be irritating to the skin, and may stain the skin black. If you have any questions about this, check with your health care professional.
Taking large doses of aspirin or other salicylates (including diflunisal) while using topical salicylic acid (contained in salicylic acid and sulfur) may lead to overdose. If you have any questions about this, check with your health care professional.
","Pediatric: Young children may be at increased risk of unwanted effects because of increased absorption of salicylic acid through the skin. Products containing salicylic acid should not be applied to large areas of the body or used for long periods of time in infants and children.
Geriatric: Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of salicylic acid and sulfur combination in the elderly with use in other age groups.
",,,,"Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed.
",12
+913,Prazosin Hydrochloride,prazosin-hydrochloride-913,https://medex.com.bd/attachments/K7BLoQ50yXogMcKbwVEnFC7jFVyIt5/prazosin-hydrochloride-prescribing-information,Alpha adrenoceptor blocking drugs,Hypertension,"Hypertension (Primary and Secondary Hypertension). Raynaud's phenomenon and Raynaud's disease, Congestive heart failure (Prazosin may be used alone or added to the therapeutic regimen in those patients with congestive heart failure who are resistant or refractory to conventional therapy with diuretics ... Read more
Hypertension (Primary and Secondary Hypertension). Raynaud's phenomenon and Raynaud's disease, Congestive heart failure (Prazosin may be used alone or added to the therapeutic regimen in those patients with congestive heart failure who are resistant or refractory to conventional therapy with diuretics and/or cardiac glycosides) & Benign prostatic hyperplasia (For the symptomatic treatment of urinary obstruction due to BPH and in patients awaiting prostatic surgery).
","Alpha adrenoceptor blocking drugs
","Prazosin causes a decrease in total peripheral vascular resistance through selective inhibition of postsynaptic alpha-1-adrenoreceptors in vascular smooth muscle. In hypertensive patients, blood pressure is lowered in both the supine and standing positions; this effect is more pronounced on the diastolic blood pressure. Rebound elevation of blood pressure does not occur following abrupt cessation of Prazosin therapy.
The therapeutic efficacy of Prazosin in patients with congestive heart failure is ascribed to a reduction in left ventricular filling pressure, reduction in cardiac impedance and an augmentation of cardiac output. The use of Prazosin in congestive heart failure does not provoke a reflex tachycardia and blood pressure reduction is minimal in normotensive patients. Prazosin reduce the severity of the signs, symptoms, frequency and duration of attacks, in patients with Raynaud's disease. In low dosage, antagonism of alpha-1-receptors on prostatic and urethral smooth muscle has been shown to improve the urinary pressure profile in men and to improve symptoms of benign prostatic hyperplasia. Clinical studies have shown that Prazosin therapy is not associated with adverse changes in the serum lipid profile.
","Hypertension:
+
+- Recommended starting dose: 0.5 mg (in the evening), twice or thrice daily for 3 to 7 days. This dose should be increased to 1 mg twice or three times daily for a further 3 to 7 days. Thereafter, the daily dose should be increased gradually as determined by the patient's response to the blood pressure lowering effect. Most patients are likely to be maintained on a dosage regimen of Prazosin alone of up to 15 mg daily in divided doses.
+- Maximum dose: 20 mg in divided doses.
+
+Patients receiving other antihypertensive therapy but with inadequate control:
+
+- The dosage of the other drug should be reduced to a maintenance level and Prazosin initiated at 0.5 mg in the evening, then continuing with 0.5 mg twice or three times daily.
+- Subsequent dosage increases should be made gradually depending upon the patient's response.
+
+Congestive heart failure:
+
+- The recommended starting dose: 0.5 mg two, three or four times daily, increasing to 4 mg in divided doses. Dosage should be adjusted according to the patient's response, based on careful monitoring of cardiopulmonary signs and symptoms.
+- Usual daily maintenance dosage: 4 mg to 20 mg in divided doses.
+
+Raynaud's disease:
+
+- The recommended starting dosage: 0.5 mg twice daily given for a period of 3 to 7 days and should be adjusted according to the patient's clinical response.
+- Usual maintenance dosage: 1 mg or 2 mg twice daily.
+
+Benign prostatic hyperplasia:
+
+- The recommended dosage: 0.5 mg twice daily for a period of 3 to 7 days, with the initial dose administered in the evening. The dosage should then be adjusted according to clinical response.
+- The usual maintenance dosage: 2 mg twice daily.
+
","May be taken with or without food. Starting dose is best taken within dinner, at least 2-3 hr before retiring. Maintenance doses may be taken with or without meals.
","
+- Use with phosphodiesterase-5 inhibitors (PDE-5 Inhibitors): Concomitant use f PDE-5 inhibitors (e.g. Sildenafil, Tadalafil, Vardenafil) and Prazosin may lead to symptomatic hypotension in some patients.
+- Adding Prazosin to beta-adrenergic antagonist or calcium antagonist therapy may produce a substantial reduction in blood pressure.
+
","Prazosin is contraindicated in patients with known sensitivity to Prazosin & other quinazolines or any of the excipients.
","The most common side effects of Prazosin are allergic reaction, depression, nervousness, insomnia, Hallucinations, dizziness, drowsiness, headache, faintness, syncope, paraesthesia, worsening of pre-existing narcolepsy, blurred vision, eye pain, reddened sclera, vertigo, tinnitus, palpitations etc.
","Pregnancy category C. It should be used only when, in the opinion of the physician, potential benefit outweighs potential risk. Prazosin has been shown to be excreted in small amounts in human milk. Caution should be exercised when Prazosin is administered to nursing mothers.
","In patients with benign prostatic hyperplasia: Prazosin is not recommended for patients with a history of micturition syncope. It should not normally be administered to patients already receiving another alpha-1-antagonist.
In patients with congestive heart failure: Prazosin is not recommended in the treatment of congestive cardiac failure due to mechanical obstruction such as aortic valve stenosis, mitral valve stenosis, pulmonary embolism and restrictive pericardial disease.
In patients with hypertension: Postural hypotension evidenced by dizziness and weakness, or rarely loss of consciousness, has been reported, particularly with the commencement of therapy
","Patients with moderate to severe grades of renal impairment: Evidence to date shows that Prazosin does not further compromise renal function when used in patients with renal impairment. As some patients in this category have responded to small doses of Prazosin, it is recommended that therapy be initiated at 0.5 mg daily and that dosage increases be instituted cautiously.
Patients with hepatic dysfunction: it is recommended that therapy should be initiated at 0.5 mg daily and that dosage should be increased cautiously.
Use in the elderly: Since the elderly may be more susceptible to hypotension, therapy should be initiated with the lowest possible dose.
",,,,"Keep away from light and moisture, store below 30°C. Keep away from reach out of the children.
",12
+912,Prasugrel Hydrochloride,prasugrel-hydrochloride-912,https://medex.com.bd/attachments/XEiurhYL3B89pTreEo1w03OVLiKDqP/prasugrel-hydrochloride-prescribing-information,Anti-platelet drugs,Unstable angina,"Prasugrel is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows:
+
+- Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI).
... Read more
Prasugrel is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows:
+
+- Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI).
+- Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI.
+
","Anti-platelet drugs
","Prasugrel is an inhibitor of platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets.
","Treatment should be initiated with a single 60 mg oral loading dose. Continue at 10 mg once daily with or without food. Consider 5 mg once daily for patients <60 kg. Patients should also take aspirin (75 mg to 325 mg) daily.
",,"
+- Coadministration of Prasugrel and warfarin increases the risk of bleeding.
+- Coadministration of Prasugrel and NSAIDs (used chronically) may increase the risk of bleeding.
+- Prasugrel can be administered with drugs that are inducers or inhibitors of cytochrome P450 enzymes. Prasugrel can be administered with aspirin (75 mg to 325 mg per day), heparin, GPIIb/IIIa inhibitors, statins, and drugs that elevate gastric pH, including proton pump inhibitors and H2 blockers.
+
","
+- Active pathological bleeding such as peptic ulcer or intracranial haemorrhage.
+- Patient with a history of prior transient ischemic attack or stroke
+
","
+- Bleeding
+- Thrombotic thrombocytopenic purpura
+- Other side effects (Headache, back pain, dyspnea, nausea, hypertension, bradycardia, rash etc)
+
","There are no adequate and well-controlled studies of Prasugrel use in pregnant women. Reproductive and developmental toxicology studies in rats and rabbits at doses of up to 30 times the recommended therapeutic exposures in humans revealed no evidence of fetal harm; however, animal studies are not always predictive of a human response.
It is not known whether Prasugrel is excreted in human milk. Because many drugs are excreted in human milk, Prasugrel should be used during nursing only if the potential benefit to the mother justifies the potential risk to the nursing infant.
","
+- CABG-related bleeding: Risk increases in patients receiving Prasugrel who undergo CABG.
+- Discontinuation of Prasugrel: Premature discontinuation increases risk of stent thrombosis, MI, and death
+
","Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: Patients > 75 years of age who received Prasugrel had an increased risk of fatal bleeding events (1.0%) compared to patients who received Clopidogrel (0.1%).
Renal Impairment: No dosage adjustment is necessary for patients with renal impairment. There is limited experience in patients with end-stage renal disease.
Hepatic Impairment: No dosage adjustment is necessary in patients with mild to moderate hepatic impairment.
","In rats, lethality was observed after administration of 2000 mg/kg. Platelet transfusion may restore clotting ability. The prasugrel active metabolite is not likely to be removed by dialysis.
",,,"Keep in dry place and away from light and heat. Keep out of the reach of children.
",12
+1506,Pramoxine Hydrochloride + Calamine,pramoxine-hydrochloride-calamine-1506,https://medex.com.bd/attachments/pD0A2KX8mTEFH5a98SoqqDaMyDpW5Z/pramoxine-hydrochloride-calamine-prescribing-information,Topical Analgesics,Sunburn,"For temporary relief of pain and itching associated with minor burns, sunburns, minor cuts, scrapes, insect bites, minor skin irritations and rashes
","Topical Analgesics
","Pramoxine Hydrochloride blocks Na+ ion channel in neuronal cell membrane and prevents pain transmission, thereby effecting local anesthetic action. Calamine causing a cooling sensation and provides anti-itching action.
","Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age: Consult with a doctor.
",,"No significant interactions known or found for this cream. Caution always advised with multiple medications.
",,"Local skin reaction, e.g. anaphylactoid, burning, stinging, contact dermatitis, tenderness, urticaria, skin peeling and skin lesions
","Pregnancy Category: Undetermined. No safety information is available on the use of this product during pregnancy and lactation. Pregnant and breastfeeding patients should seek advice of health professional before using this cream.
","This preparation is for topical use only. Avoid contact of this medicine with the eyes, nose, ears and mouth. If the medication gets in these areas, wipe it off and rinse immediately with water. Stop using this medication and tell your doctor if your condition worsens, if symptoms do not improve within 7 days or persist after 7 days of treatment or if symptoms clear up and return in a few days. Do not apply to wound or damage skin and not bandage tightly in the affected area. This medicine may be harmful if swallowed. If swallowed get medical help or contact a poison center immediately
",,,,,"This cream should be stored at room temperature of 20°C - 25°C. Keep out of the reach of children
",9
+911,Pramipexole,pramipexole-911,https://medex.com.bd/attachments/6Gnf6akV7UW2pG0nkLw19AC5JM3n9J/pramipexole-prescribing-information,Antiparkinson drugs,Parkinson’s disease,"Pramipexole is indicated for the treatment of-
+
+- Parkinson's disease used alone or as an adjunct to levodopa with dopa-decarboxylase inhibitor
+- Moderate to severe restless legs syndrome
+
","Antiparkinson drugs
","The exact mechanism of action of pramipexole as a treatment for Parkinson's disease is unknown at this time. It is thought, however, that the ability of pramipexole to cause stimulation of the dopamine receptors in the striatum of the brain, a region that receives a vast array of neurological input and is responsible for a wide variety of functions, may be involved. Studies performed in animals show that pramipexole influences striatal neuronal transmission rates following activation of dopamine receptors. Pramipexole is considered a non-ergot dopamine agonist that shows specificity and strong activity at the D2 subfamily of dopamine receptors in vitro, binding selectively and dopamine D2 receptors and showing a preference for the dopamine D3 receptor subtype rather than other subtypes. The clinical significance of this binding specificity is unknown.
","The recommended dose of Pramipexole is as follows-
Parkinson's disease:
+
+- Initial dose: 88 micrograms 3 times daily, dose doubled every 5-7 days if tolerated to 350 micrograms 3 times daily; further increased if necessary by 180 micrograms 3 times daily at weekly intervals
+- Maximum dose: 3.3 mg daily in 3 divided doses. During pramipexole dose titration and maintenance Levodopa dose should be reduced.
+
+Restless legs syndrome:
+
+- Initial dose: 88 micrograms once daily 2-3 hours before bedtime, dose doubled every 4-7 days if necessary to 350 micrograms daily.
+- Maximum dose: 540 micrograms daily.
+
+Use in children: Pramipexole is not recommended for children below 18 years of age.
",,"Pramipexole is the only dopamine agonist not appreciably metabolized by the P450 system which minimizes about possible drug-drug interactions. Cimetidine and amantadine may reduce the renal clearance of pramipexole. Sedating medicinal products or alcohol in combination with pramipexole may cause additive effects.
","Pramipexole is contraindicated in patients with known Hypersensitivity to the active substance or to any of the excipients.
","The common side effects are dizziness, dyskinesia, nausea, hypotension, abnormal dreams, confusion, constipation, delusion, hallucinations, headache, hyperkinesia, increased eating (binge eating, hyperphagia), insomnia, libido disorders, nausea, peripheral oedema, paranoia, pathological gambling, hypersexuality and other abnormal behaviour, somnolence, weight increase, sudden onset of sleep, pruritus and rash and other hypersensitivity.
","The effect of pramipexole on pregnancy and lactation has not been investigated in humans so it should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Pramipexole inhibits secretion of prolactin in humans. The excretion of pramipexole into breast milk has not been studied in women so it should not be used during breast-feeding. However, if its use is unavoidable then breast-feeding should be discontinued.
","Caution should be taken in patients with psychotic disorder, ophthalmologic monitoring is recommended at regular intervals, severe cardiovascular disease and renal impairment.
",,"There is no clinical experience with massive overdose. Symptoms of overdose are nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension. There is no established antidote. If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated. Management of the overdose may require general supportive measures, along with gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram monitoring.
",,,"Store in a cool and dry place. Protect from light.
",11
+910,Pralidoxime Chloride,pralidoxime-chloride-910,https://medex.com.bd/attachments/CuedFC16VSJRaAxzOG81aNL2LJeiRL/pralidoxime-chloride-prescribing-information,Antidote preparations,Organophosphorous poisoning,"Pralidoxime chloride is indicated as an antidote:
+
+- In the treatment of poisoning due to those pesticides and chemicals (e.g., nerve agents) of the organophosphate class which have anticholinesterase activity and
+- In the control of overdosage by anticholinesterase drugs used in the treatment of myasthenia gravis.
... Read more
Pralidoxime chloride is indicated as an antidote:
+
+- In the treatment of poisoning due to those pesticides and chemicals (e.g., nerve agents) of the organophosphate class which have anticholinesterase activity and
+- In the control of overdosage by anticholinesterase drugs used in the treatment of myasthenia gravis.
+
+The principal indications for the use of Pralidoxime chloride are muscle weakness and respiratory depression. In severe poisoning, respiratory depression may be due to muscle weakness.
","Antidote preparations
","Pralidoxime reactivates cholinesterase outside the CNS that had been inactivated by phosphorylation due to exposure to certain organophosphates by displacing the enzyme from its receptor sites. It removes the phosphoryl group from the active site of the inactivated enzyme by nucleophilic attack, regenerating active cholinesterase and forming an oxime complex. It also detoxifies certain organophosphates by direct chemical reaction.
","Intramuscular-
+Organophosphorus poisoning:
+
+- Adult: Mild: 600 mg, repeat 1-2 times at 15 min intervals as needed. Severe: 1.8 g given as 3 inj of 600 mg in rapid succession. Persistent: May repeat the entire series (1.8 g) beginning 1 hr after admin of the last inj.
+- Child: <40 kg: Mild: 15 mg/kg, repeat as needed every 15 min. Max: 45 mg/kg. Severe: 15 mg/kg, repeat twice in rapid succession to a total dose of 45 mg/kg. Persistent: May repeat the entire series (45 mg/kg) beginning 1 hr after admin of the last inj; ≥40 kg: Same as adult dose.
+
+
+
Intravenous-
+Organophosphorus poisoning:
+
+- Adult: In combination with atropine: Loading dose: 1-2 g by infusion over 15-30 min or slow inj over at least 5 min, may repeat dose after 1 hr then 10-12 hrly, as needed. Administer as soon as the effects of atropine are observed. Maintain atropinisation for at least 48 hr.
+- Child: ≤16 yr Loading dose: 20-50 mg/kg (max: 2 g/dose) by inj over 15-30 min followed by 10-20 mg/kg/hr as continuous infusion. Alternatively, a repeat bolus of 20-50 mg/kg after 1 hr and repeated 10-12 hrly as needed; >16 yr Same as adult dose.
+
+Poisoning or overdosage with compounds having muscarinic actions:
+
+- Adult: Initially, 1-2 g, followed by 0.5-1 g/hr as infusion. Alternatively, the initial dose may be repeated after 1 hr and then 3-8 hrly as needed.
+
",,,"There are no known absolute contraindications for the use of Pralidoxime Chloride. Relative contraindications include known hypersensitivity to the drug and other situations in which the risk of its use clearly outweighs possible benefit.
","Drowsiness, dizziness, visual disturbances, nausea, HTN, tachycardia, headache, hyperventilation, muscle weakness, impaired renal function, elevated liver enzymes, transient increase in creatine phosphokinase, transient neuromuscular blockade; mild to moderate pain at inj site.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Patient with myasthenia gravis receiving anticholinesterase agents. Not indicated in the treatment of poisoning due to phosphorous, inorganic phosphates, or organophosphates without anticholinesterase activity and carbamate pesticides. Renal impairment. Pregnancy and lactation.
",,"Manifestations of Overdosage: Observed in normal subjects only: dizziness, blurred vision, diplopia, headache, impaired accommodation, nausea, slight tachycardia. In therapy it has been difficult to differentiate side effects due to the drug from those due to the effects of the poison.
",,"Intramuscular: Dilute 1 g with 3.3 mL sterile water for inj to a final concentration of 300 mg/mL.
Intravenous: Dilute 1 g with 20 mL of sterile water for inj to make a concentration of 50 mg/mL to be administered in fluid-restricted patients or when rapid admin is required; for all other patients, further dilute with normal saline to a final concentration of 20 mg/mL.
","Store between 20-25° C.
",11
+907,Povidone Iodine,povidone-iodine-907,,Iodine compounds (Anti-septic Preparations),Secondarily infected dermatoses,"Cream or ointment:
Therapeutically: As an adjunct to systemic therapy in the following indications-
+
+- Primary or secondary topical infections
+- Infected surgical incisions
+- Infected decubitus or stasis ulcers
+- Pyodermas
+- Secondarily infected dermatoses
... Read more
Cream or ointment:
Therapeutically: As an adjunct to systemic therapy in the following indications-
+
+- Primary or secondary topical infections
+- Infected surgical incisions
+- Infected decubitus or stasis ulcers
+- Pyodermas
+- Secondarily infected dermatoses
+- Infected traumatic lesions
+
+Prophylactically:
+
+- To prevent microbial contaminations in burns, incisions and other topical lesions
+- For degerming skin in hyperalimentation, the umbilical area or circumcision
+- Its use for abrasions, minor cuts, and wounds prevents the development of infections and permits wound healing.
+
+
Solution:
+
+- For the prevention and treatment of surface infections as well as to degerm the skin, mucous membrane and hyperalimentation procedures
+- For seborrhea
+- For preoperative and postoperative scrubbing and washing of hospital operating room and equipments
+- For preoperative prepping of operative site, including the vagina
+- For disinfection of wounds, burns, lacerations and abrasions
+- As a prophylactic anti-infective agent in house, hospital & office procedures
+- Postoperative application to incisions to help prevent infection
+- In oral moniliasis (thrush); bacterial and mycotic skin infections, decubitus & stasis ulcers
+- As a preoperative swab in the mouth & throat
+
+
Gargle & Mouthwash: It is a pleasantly flavoured solution which is used:
+
+- For the treatment of acute mucosal infections of the mouth and pharynx.
+- For oral hygiene prior to, during and after dental and oral surgery.
+
+
Surgical Scrub: It is a golden surfactant solution, forms rich, golden lather which is used: As an antiseptic skin cleanser for preoperative and postoperative scrubbing and washing by surgeons and operation theatre staff and preoperative preparation of patients' skin
Powder: It is used for topical application in the following indications: Superficial wounds, Minor cuts, Burns, Abrasions, Lacerations, In the treatment and prevention of infections.
Ophthalmic Solution: Povidone is used for the symptomatic treatment of dry eye conditions including keratoconjunctivitis sicca. It is also given as a substitute for tear fluid in case of the unstable tear film or insufficient moistening of the eye surface.
","Iodine compounds (Anti-septic Preparations)
","Povidone Iodine is a complex of iodine and an organic polymer, povidone. This polymerization makes Povidone Iodine superior to ordinary elemental iodine. It prolongs the germicidal activity of iodine by liberating elemental iodine slowly. Consequently it has a lower toxicity than elemental iodine. It gives rapid microbicidal activity against both Gram-positive and Gram-negative bacteria, protozoa, viruses and fungi/yeasts. It is also sporicidal. It is the only microbicide with this broad spectrum of activity. It is non-staining, exerts prolong germicidal action and is also active in the presence of soap, blood, serum, pus, mucosal secretions and water.
","Cream or ointment:
+
+- For the treatment of infection: Apply once or twice daily or at dressing changes for a maximum of 14 days.
+- For the prevention of infection: Apply once or twice a week for as long as necessary. The affected skin should be cleaned and dried and can be covered with a dressing or bandage.
+
+
Solution: Apply full strength as often as needed as paint, spray, or wet soak. Maybe bandaged (where necessary).
Gargle & Mouthwash: Adults and children over 6 years of age: Use undiluted or diluted with an equal volume of warm water. Gargle or rinse with up to 10 mL for up to 30 seconds without swallowing. Repeat up to four times daily, for up to 14 consecutive days, or as advised by the Registered Dental Surgeon/Physician.
Surgical Scrub:
+
+- For Preoperative and Postoperative washing by Operating Personnel: Wet hands and forearms with water. Pour about 5 mL of Povidone Iodine Surgical Scrub on the palm of the hand and spread over both hands and forearms. Without adding more water, rub the Scrub thoroughly over all areas for about five minutes. Use a brush if desired. Clean thoroughly under fingernails. Add a little water and develop copious suds. Rinse thoroughly under running water. Complete the wash by scrubbing with another 5 mL of Povidone Iodine Surgical Scrub in the same way.
+- For Preoperative use on Patients: After the skin area is shaved, wet it with water. Apply Povidone Iodine Surgical Scrub (1 mL is sufficient to cover an area of 20-30 square inches), develop lather and scrub thoroughly for about five minutes. Rinse off by aid of sterile gauze saturated with water.
+- For use in the Physician's Office: Use for washing whenever a germicidal soap is required.
+
+
Powder: Apply a light dusting of powder to the affected area. When dry, this forms a protective antiseptic layer over the area treated. Or use as advised by the Registered Physician. There are no special dosage recommendations for children or elderly patients.
Ophthalmic Solution: 1 drop 4 times daily or as required, depending upon the severity of the disease, to be instilled into the conjunctival sac.
",,"It exhibits interaction with strong alkali, sodium thiosulphate, sodium metabisulphite and thiomersal. Use with concurrent lithium therapy has been shown to exhibithypothyroidic effect.
","It can cause hypersensitivity reactions. Regular use in patients with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis) or those receiving lithium therapy is to be avoided. In severely burnt patients serum iodide levels should be assessed due to possible hepatic and renal impairment. Povidone Iodine Powder should not be used in serious cavities and in Children under the age of 2 years.
","Povidone Iodine may cause hypersensitivity reactions and irritation of the skin and mucous membranes. The application of povidone Iodine to severe burns or to large areas otherwise denuded of skin may produce systemic adverse effects such as metabolic acidosis, hypernatraemia, and impairment of renal function. It may interfere with thyroid function tests.
","Povidone Iodine Cream, Solution & Powder are not recommended for use during pregnancy because of the possibility of absorption of sufficient iodine to affect the fetal thyroid. American Academy of Pediatrics considers that the use of Povidone-Iodine is usually compatible with breast feeding. Consult Registered Physician. Regular use of Gargle & Mouthwash and Surgical Scrub should also be avoided in pregnant and lactating women.
There is no experience regarding the safety of the Povidone eye drops in human pregnancy or lactation. Administration during pregnancy and lactation is therefore not recommended, except for compelling reasons.
","Cream or ointment: In case of deep or puncture wounds or serious burns, consult Registered Physician. If redness, irritation, swelling or pain persists or increases or if infection occurs, discontinue use and consult Registered Physician.
Solution: In preoperative prepping, avoid 'pooling' beneath the patient. Prolonged exposure to wet solution may cause irritation or rarely, severe skin reactions. In case of deep or puncture wounds or serious burns, consult Registered Physician. If redness, irritation, swelling or pain persists or increases or if infection occurs, discontinue use and consult Registered Physician.
Gargle & Mouthwash: Regular use should be avoided as prolonged use may lead to the absorption of a significant amount of iodine. Do not use for more than 14 days. If sores or ulcers in the mouth do not heal within 14 days seek dental or medical advice. It is also not for use in children under 6 years of age. Regular use should be avoided in patients on concurrent lithium therapy.
Surgical Scrub: Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency. Regular use should be avoided in patients on concurrent lithium therapy. It can permanently discolor white gold jewellery and it is recommended that this type of jewellery should be removed before using this product.
Powder: Care must be taken when used on known iodine sensitivity, although do not normally react to Povidone-Iodine. Excess powder can be washed off readily with warm water. It should be used directly from the container. Not to be administered internally.
Ophthalmic Solution: Patients, who experience blurred vision after application of the eye drops, should not drive or use machinery until their vision has cleared. Contact lenses should not be worn during the instillation of the drug. After instillation, there should be an interval of at least 30 minutes before reinsertion.
",,,,,"Store below 25°C. Do not freeze. Store in a cool and dry place, protected from light. Keep out of the reach of children. Do not touch the ophthalmic solution dropper tip to any surface as this may contaminate this preparation. Do not use it after one month of the first opening.
",10
+270,Potassium Citrate + Citric Acid,potassium-citrate-citric-acid-270,,Prevention of repeated kidney stone formation,Urine alkalinisation,"This preparation is indicated in the following cases:
+
+- To relieve discomfort in urinary tract infections
+- To prevent kidney stone
+- With uricosuric agent to prevent gout
+- Acidosis caused by kidney diseases
+
","Prevention of repeated kidney stone formation, Urinary Alkalinizing Agent
","Potassium Citrate and Citric Acid oral solution is a stable and pleasant-tasting oral systemic alkalizer. Potassium Citrate is absorbed and metabolized to Potassium Bicarbonate, thus acting as a systemic alkalizer. This product alkalinizes the urine without producing a systemic alkalosis in recommended doses. It is highly palatable, pleasant tasting and tolerable, even when administered for long periods. Potassium Citrate does not neutralize the gastric juice or disturb digestion.
","To relieve discomfort in UTI:
+
+- Adults and children over 6 years: 10 ml 3 times daily, diluted with 1 glass of water.
+- Children 1-6 years: 5 ml 3 times daily, diluted with ½ glass of water.
+
+To prevent kidney stones, With a uricosuric agent to prevent gout, Acidosis caused by kidney diseases:
+
+- Adults: 10-15 ml 4 times daily (or as directed by the physician) diluted with 1 glass of water.
+- Pediatric: 5-10 ml 4 times daily (or as directed by the physician) diluted with ½ glass of water.
+
",,"Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors or cardiac glycosides may lead to toxicity.
","The drug is contraindicated in severe renal impairment with oliguria or azotemia, untreated Addison's disease, acute dehydration, severe myocardial damage and hyperkalemia from any cause.
","This solution is generally well tolerated without any unpleasant side effect when given in recommended doses to patients with normal renal function and urinary output. However, as with any alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of hyperkalemia or alkalosis. Potassium intoxication causes listlessness, weakness, mental confusion, tingling of extremities and other symptoms associated with a high concentration of Potassium in the serum.
","No information is available regarding the use of this drug during pregnancy and lactation.
","The solution should be used with caution in patients with low urinary output. It should be diluted adequately with water to minimize the possibility of gastrointestinal injury associated with the oral ingestion of concentrated Potassium salt preparations; and preferably, to take each dose after meals. Large doses may cause hyperkalemia and alkalosis, especially in the presence of renal disease.
",,"The administration of oral Potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, hyperkalemia can result. Hyperkalemia, when detected, must be treated immediately because lethal levels can be reached in a few hours. If hyperkalemia occurs, treatment measures will include the followings: (1) Elimination of foods or medications containing potassium. (2) The intravenous administration of 300 to 500 ml/hr of dextrose solution (10 to 25%), containing 10 units of insulin/20 gm dextrose. (3) The use of exchange resins, hemodialysis or peritoneal dialysis.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+916,Potassium Citrate,potassium-citrate-916,https://medex.com.bd/attachments/VaV1VTqmf0dOFBuHd5wnP7HJjOyss1/potassium-citrate-prescribing-information,Prevention of repeated kidney stone formation,Urinary tract infection,"Renal Tubular Acidosis (RTA) With Calcium Stones: Potassium citrate is indicated for the management of renal tubular acidosis
Hypocitraturic Calcium Oxalate Nephrolithiasis Of Any Etiology: Potassium citrate is indicated for the management of Hypocitraturic ... Read more
Renal Tubular Acidosis (RTA) With Calcium Stones: Potassium citrate is indicated for the management of renal tubular acidosis
Hypocitraturic Calcium Oxalate Nephrolithiasis Of Any Etiology: Potassium citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis
Uric Acid Lithiasis With Or Without Calcium Stones: Potassium citrate is indicated for the management of Uric acid lithiasis with or without calcium stones
","Prevention of repeated kidney stone formation
","When Potassium Citrate is given orally, the metabolism of absorbed citrate produces an alkaline load. The induced alkaline load in turn increases urinary pH and raises urinary citrate by augmenting citrate clearance without measurably altering ultrafilterable serum citrate. Thus, Potassium Citrate therapy appears to increase urinary citrate principally by modifying the renal handling of citrate, rather than by increasing the filtered load of citrate. The increased filtered load of citrate may play some role, however, as in small comparisons of oral citrate and oral bicarbonate, citrate had a greater effect on urinary citrate.
In addition to raising urinary pH and citrate, Potassium Citrate increases urinary potassium by approximately the amount contained in the medication. In some patients, Potassium Citrate causes a transient reduction in urinary calcium.
The changes induced by Potassium Citrate produce urine that is less conducive to the crystallization of stoneforming salts (calcium oxalate, calcium phosphate and uric acid). Increased citrate in the urine, by complexing with calcium, decreases calcium ion activity and thus the saturation of calcium oxalate. Citrate also inhibits the spontaneous nucleation of calcium oxalate and calcium phosphate (brushite).
The increase in urinary pH also decreases calcium ion activity by increasing calcium complexation to dissociated anions. The rise in urinary pH also increases the ionization of uric acid to the more soluble urate ion.
Potassium Citrate therapy does not alter the urinary saturation of calcium phosphate, since the effect of increased citrate complexation of calcium is opposed by the rise in pH-dependent dissociation of phosphate. Calcium phosphate stones are more stable in alkaline urine.
In the setting of normal renal function, the rise in urinary citrate following a single dose begins by the first hour and lasts for 12 hours. With multiple doses the rise in citrate excretion reaches its peak by the third day and averts the normally wide circadian fluctuation in urinary citrate, thus maintaining urinary citrate at a higher, more constant level throughout the day. When the treatment is withdrawn, urinary citrate begins to decline toward the pre-treatment level on the first day.
The rise in citrate excretion is directly dependent on the Potassium Citrate dosage. Following long-term treatment, Potassium Citrate at a dosage of 60 mEq/day raises urinary citrate by approximately 400 mg/day and increases urinary pH by approximately 0.7 units.
In patients with severe renal tubular acidosis or chronic diarrheal syndrome where urinary citrate may be very low (<100 mg/day), Potassium Citrate may be relatively ineffective in raising urinary citrate. A higher dose of Potassium Citrate may therefore be required to produce a satisfactory citraturic response. In patients with renal tubular acidosis in whom urinary pH may be high, Potassium Citrate produces a relatively small rise in urinary pH.
","Dosing Instructions: Treatment with extended release potassium citrate should be added to a regimen that limits salt intake (avoidance of foods with high salt content and of added salt at the table) and encourages high fluid intake (urine volume should be at least two liters per day). The objective of treatment with Potassium Citrate is to provide Potassium Citrate in sufficient dosage to restore normal urinary citrate (greater than 320 mg/day and as close to the normal mean of 640 mg/day as possible), and to increase urinary pH to a level of 6.0 or 7.0.
Monitor serum electrolytes (sodium, potassium, chloride and carbon dioxide), serum creatinine and complete blood counts every four months and more frequently in patients with cardiac disease, renal disease or acidosis. Perform electrocardiograms periodically. Treatment should be discontinued if there is hyperkalemia, a significant rise in serum creatinine or a significant fall in blood hemocrit or hemoglobin.
Severe Hypocitraturia: In patients with severe hypocitraturia (urinary citrate <150 mg/day), therapy should be initiated at a dosage of 60 mEq/day (30 mEq two times/day or 20 mEq three times/day with meals or within 30 minutes after meals or bedtime snack). Twenty-four hour urinary citrate and/or urinary pH measurements should be used to determine the adequacy of the initial dosage and to evaluate the effectiveness of any dosage change. In addition, urinary citrate and/or pH should be measured every four months. Doses of Potassium Citrate greater than 100 mEq/day have not been studied and should be avoided.
Mild To Moderate Hypocitraturia: In patients with mild to moderate hypocitraturia (urinary citrate > 150 mg/day) therapy should be initiated at 30 mEq/day (15 mEq two times/day or 10 mEq three times/day within 30 minutes after meals or bedtime snack). Twenty-four hour urinary citrate and/or urinary pH measurements should be used to determine the adequacy of the initial dosage and to evaluate the effectiveness of any dosage change. Doses of Potassium Citrate greater than 100 mEq/day have not been studied and should be avoided.
",,,"Potassium Citrate is contraindicated:
+
+- In patients with hyperkalemia (or who have conditions pre-disposing them to hyperkalemia), as a further rise in serum potassium concentration may produce cardiac arrest. Such conditions include: chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown or the administration of a potassium-sparing agent (such as triamterene, spironolactone or amiloride).
+- In patients in whom there is cause for arrest or delay in tablet passage through the gastrointestinal tract, such as those suffering from delayed gastric emptying, esophageal compression, intestinal obstruction or stricture, or those taking anticholinergic medication.
+- In patients with peptic ulcer disease because of its ulcerogenic potential.
+- In patients with active urinary tract infection (with either urea-splitting or other organisms, in association with either calcium or struvite stones). The ability of Potassium Citrate to increase urinary citrate may be attenuated by bacterial enzymatic degradation of citrate. Moreover, the rise in urinary pH resulting from Potassium Citrate therapy might promote further bacterial growth.
+- In patients with renal insufficiency (glomerular filtration rate of less than 0.7 ml/kg/min), because of the danger of soft tissue calcification and increased risk for the development of hyperkalemia.
+
","Nausea, vomiting, diarrhea, and stomach pain may occur. Taking it after meals will help prevent these side effects. An empty tablet shell may appear in your stool. This is harmless because your body has already absorbed the medication.
This drug may cause serious stomach or intestinal problems (e.g., bleeding, blockage, puncture). This medication may cause high potassium levels in the blood (hyperkalemia). A very serious allergic reaction to this drug is rare.
","Pregnancy Category C. Animal reproduction studies have not been conducted. It is also not known whether Potassium Citrate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium Citrate should be given to a pregnant woman only if clearly needed.
Nursing Mothers: The normal potassium ion content of human milk is about 13 mEq/L. It is not known if Potassium Citrate has an effect on this content. Potassium Citrate should be given to a woman who is breast feeding only if clearly needed.
","This medication should not be used ifpatient have (Addison's disease), current bladder infection, uncontrolled diabetes, severe heart disease (e.g., recent heart attack, heart damage), certain stomach/intestinal problems (diabetic gastroparesis, conditions decreasing gut movement, peptic ulcer, blockage), severe kidney disease (e.g., inability to make urine), potassium-restricted diet, high potassium levels, severe loss of body water (dehydration).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: low calcium levels, severe diarrhea, heart problems (e.g., irregular heartbeat, heart failure), kidney disease, stomach/gut problems (e.g., irritable bowel), severe tissue damage (e.g., severe burns). Before having surgery, tell your doctor or dentist that you are taking this medication.
","Pediatric Use: Safety and effectiveness in children have not been established.
","Treatment Of Overdosage: The administration of potassium salts to persons without predisposing conditions for hyperkalemia rarely causes serious hyperkalemia at recommended dosages. It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration and characteristic electrocardiographic changes (peaking of T-wave, loss of P-wave, depression of S-T segment and prolongation of the QT interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest.
Treatment measures for hyperkalemia include the following:
+
+- Patients should be closely monitored for arrhythmias and electrolyte changes.
+- Elimination of medications containing potassium and of agents with potassium-sparing properties such as potassium-sparing diuretics, ARBs, ACE inhibitors, NSAIDs, certain nutritional supplements and many others.
+- Elimination of foods containing high levels of potassium such as almonds, apricots, bananas, beans (lima, pinto, white), cantaloupe, carrot juice (canned), figs, grapefruit juice, halibut, milk, oat bran, potato (with skin), salmon, spinach, tuna and many others.
+- Intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity.
+- Intravenous administration of 300-500 mL/hr of 10% dextrose solution containing 10-20 units of crystalline insulin per 1,000 mL.
+- Correction of acidosis, if present, with intravenous sodium bicarbonate.
+- Hemodialysis or peritoneal dialysis.
+- Exchange resins may be used. However, this measure alone is not sufficient for the acute treatment of hyperkalemia.
+
+Lowering potassium levels too rapidly in patients taking digitalis can produce digitalis toxicity.
",,,,10
+904,Potassium Chloride,potassium-chloride-904,https://medex.com.bd/attachments/jeDHO7u0l6drAYTVl5Bu87OCbJeMMq/potassium-chloride-tablet-prescribing-information,Electrolytes preparations,Ulcerative colitis,"Potassium Chloride is indicated in-
+
+- Replacement of potassium deficit
+- Diuretic (Potassium losing)-induced hypokalaemia
+- Hypokalaemia from renal potassium wasting
+- Hypokalaemia from gastrointestinal losses
+- Hypochloraemic alkalosis associated with hypokalaemia
+
","Electrolytes preparations, Oral electrolytes preparations
","Potassium Chloride is used for the treatment of hypokalaemia and of potassium deficiency states. Potassium ion is the principal intracellular cation of most body tissues. It participates in a number of essential physiological processes, including the maintenance of intracellular tonicity, the transmission of nerve impulses, the contraction of cardiac, skeletal and smooth muscle and the maintenance of normal renal function.
","Oral dose: It should be taken with or after meals with plenty of fluid (water/fruit juice). Typical doses for the prevention of hypokalaemia may be upto 50 mmol (about 37.5 mL) daily by mouth. Oral treatment may be suitable in some cases of hypokalaemia and similar doses to those used for prevention may be adequate in mild potassium deficiency. However, higher doses may be needed in more severe deficiency.
Parenteral dose: Intravenous administration may be required in acute hypokalaemia. One ampoule (10 mL) i.e. 1.5 gm (20 mmol k+) may be added to 500 mL of sodium chloride or glucose intravenous infusion and given slowly over 2 to 3 hours with specialist advice and ECG monitoring in difficult cases. Repeated measurements of potassium are necessary to determine whether further infusions are required and to avoid the development of hyperkalaemia. This is especially liable to occur in renal impairment.
",,"Combined treatment with the following increase the risk of hyperkalaemia: Angiotensin-converting enzyme inhibitors, cyclosporin, NSAIDs, beta-blockers, heparin, digoxin, potassium-sparing diuretics.
","Hypersensitivity to potassium administration e.g. hyperkalaemic periodic paralysis, congenital paramyotonia, marked renal failure (even when not yet associated with manifest hyperkalaemia), untreated Addison's disease, hyporeninaemic hypoaldosteronism, acute dehydration, hyperkalaemia and conditions involving extensive cell destruction (e.g. severe burns). In case of metabolic acidosis, the hypokalaemia should be treated not with potassium chloride.
","Excessive administration of potassium leads to development of hyperkalaemia, the symptoms of which include paraesthesia of the extremitis, muscle weakness, paralysis, hypotension, cardiac arrhythmias, heart block and cardiac arrest. Pain or phlebitis may occur during I.V. administration of solutions containing about 30 mmol or more potassium per litre. Nausea, vomiting, diarrhoea and abdominal cramps may occur following oral administration.
","As a general rule, no drugs should be taken during the first three months of pregnancy and the risks & benefits of taking drugs should be carefully considered throughout pregnancy. There are no contraindications to breastfeeding while taking potassium salts.
","It should be administered with caution to patients with renal or adrenocortical insufficiency, cardiac disease, acute dehydration, heat cramps, extensive tissue destruction as occurs with severe burns, or to patients receiving potassium-sparing diuretics. Excessive use of potassium-containing salt substitutes or concurrent administration with potassium supplements may lead to accumulation of potasssium especially in patients with renal insufficiency. Attention should be paid to the concurrent use of other drugs that either contain potassium or have the potential for hyperkalaemia. Treatment should be discontinued if severe nausea, vomiting or abdominal distress develops.
","Use in children: No special precautions are required.
",,,,"Store below 25°C in a dry place, away from light. Keep out of the reach of children.
",11
+1862,Posaconazole,posaconazole-1862,https://medex.com.bd/attachments/9DRCK8Lj2Cek0IvzvSge4FQIX1smrE/posaconazole-prescribing-information,Aural Anti-fungal preparations,Invasive aspergillosis,"Posaconazole is indicated in patients aged 13 years and above for the treatment of the following fungal infections:
+
+- Invasive aspergillosis in patients with disease that is refractory or intolerant to Amphotericin B or Itraconazole
+- Fusariosis in patients with disease that is refractory or intolerant to Amphotericin B
... Read more
Posaconazole is indicated in patients aged 13 years and above for the treatment of the following fungal infections:
+
+- Invasive aspergillosis in patients with disease that is refractory or intolerant to Amphotericin B or Itraconazole
+- Fusariosis in patients with disease that is refractory or intolerant to Amphotericin B
+- Chromoblastomycosis and mycetoma in patients with disease that is refractory or intolerant to Itraconazole
+- Coccidioidomycosis in patients with disease that is refractory or intolerant to Amphotericin B, Itraconazole or Fluconazole or in patients who are intolerant of these medicinal products.
+
+Also indicated for prophylaxis of invasive fungal infections in the following patients:
+
+- Patients receiving remission-induction chemotherapy for Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections
+- Hematopoietic Stem Cell Transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy
+
","Aural Anti-fungal preparations
","Posaconazole blocks the synthesis of ergosterol, a key component of the fungal cell membrane. It inhibits the cytochrome P-450 dependent enzyme Lanosterol 14-α-demethylase responsible for the conversion of lanosterol to ergosterol in the fungal cell membrane. This results in an accumulation of methylated sterol precursors and a depletion of ergosterol within the cell membrane, thus weakening the structure and function of the fungal cell membrane.
","Posaconazole Tablets can be taken with or without food. The tablets should be swallowed whole with water and should not be crushed, chewed, or broken.
Loading Dose: 300 mg (3 Tablets) twice a day on the first day.
Maintenance Dose: 300 mg (3 Tablets) once a day from the second day.
Duration of therapy should be based on the severity of the underlying disease, recovery from immunosuppression and clinical response.
",,"Posaconazole is an inhibitor of CYP3A4 and should only be used under specific circumstances during treatment with other medicinal products that are metabolized by CYP3A4 like Midazolam, Triazolam, Alprazolam. Posaconazole concentrations may be significantly lowered in combination with Rifamycin antibacterials (Rifampicin, Rifabutin), certain anticonvulsants (Phenytoin, Carbamazepine, Phenobarbital, Primidone and Efavirenz).
","Posaconazole is contraindicated in persons with known hypersensitivity to Posaconazole or other azole antifungal agents. Co-administration with ergot alkaloids, CYP3A4 substrates, Terfenadine, Astemizole, Cisapride, Pimozide, Halofantrine or Quinidine since this may result in increased plasma concentrations of these medicinal products leading to QTc prolongation and rare occurrences of torsades de pointes, HMG-CoA reductase inhibitors simvastatin, lovastatin and atorvastatin is contraindicated.
","Common treatment-emergent adverse reactions in studies with Posaconazole are diarrhea, nausea, fever, vomiting, headache, coughing and hypokalemia.
","Posaconazole must not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the fetus. Breast-feeding must be stopped on initiation of treatment with this drug.
",,"Pediatric Use: Safety and effectiveness in pediatric patients below the age of 13 years has not been established. Therefore, Posaconazole is not recommended for pediatric patients less than 13 years of age.
Geriatric Use: No dose adjustment is necessary for geriatric patients.
Hepatic Impairment: Posaconazole should be used with caution in patients with hepatic impairment due to limited clinical experience and the possibility that posaconazole plasma levels may be higher in these patients. Liver function tests should be evaluated at the start of and during the course of posaconazole therapy.
Renal Impairment: No dose adjustment is required in patients with mild (eGFR: 50-80 mL/min/1.73 m2) to moderate renal impairment (eGFR: 20-49 mL/min/1.73 m2). Patients with severe renal impairment should be monitored closely for breakthrough fungal infections.
",,,,"Store below 25°C. Keep out of the reach of children.
",10
+1485,Ponatinib Hydrochloride,ponatinib-hydrochloride-1485,https://medex.com.bd/attachments/uEQKhNDvZLhAo9N5bg0plQKBBc2UH9/ponatinib-hydrochloride-prescribing-information,Tyrosine Kinase Inhibitor,Lymphocytic leukemia,"Ponatinib is a kinase inhibitor indicated for the:
+
+- Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.
+- Treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
+
","Tyrosine Kinase Inhibitor
","Ponatinib is a kinase inhibitor. Ponatinib inhibited the in vitro tyrosine kinase activity of ABL and T315I mutant ABL with IC 50 concentrations of 0.4 nM and 2.0 nM, respectively. Ponatinib inhibited the in vitro activity of additional kinases with IC 50 concentrations between 0.1 nM and 20 nM, including members of the VEGFR, PDGFR, FGFR, EPH receptors and SRC families of kinases, and KIT, RET, TIE2, and FLT3. Ponatinib inhibited the in vitro viability of cells expressing native or mutant BCR-ABL, including T315I. In mice, treatment with ponatinib reduced the size of tumors expressing native or T315I mutant BCR-ABL when compared to controls.
","Recommended dose: 45 mg taken orally once daily with or without food
Hepatic Impairment: 30 mg orally once daily. Modify or interrupt dosing for hematologic and non-hematologic toxicity
",,,"None
","The most common non-hematologic adverse reactions (≥20%) were, abdominal pain, rash, constipation, headache, dry skin, arterial occlusion, fatigue, hypertension, pyrexia, arthralgia, nausea, diarrhea, lipase increased, vomiting, myalgia and pain in extremity.
","Based on its mechanism of action and findings in animals, Ponatinib can cause fetal harm when administered to a pregnant woman. There are no available data on Ponatinib use in pregnant women. In animal reproduction studies, oral administration of ponatinib to pregnant rats during organogenesis caused adverse developmental effects at doses lower than human exposures at the recommended human dose. Advise pregnant women of the potential risk to a fetus.
There is no data on the presence of ponatinib in human milk, the effects on the breastfed infant or on milk production.
",,"Pediatric Use: Safety and effectiveness have not been established in pediatric patients.
",,,,"Store Ponatinib at room temperature between 20° C to 25° C
",9
+896,Polysaccharide Pneumococcal Vaccine,polysaccharide-pneumococcal-vaccine-896,https://medex.com.bd/attachments/MQdq4SPXiEP9bIMQpp1U8YTpexrejp/polysaccharide-pneumococcal-vaccine-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Pneumococcal pneumonia,"Polysaccharide Pneumococcal Vaccine is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F , and 33F). Polysaccharide Pneumococcal ... Read more
Polysaccharide Pneumococcal Vaccine is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F , and 33F). Polysaccharide Pneumococcal Vaccine is approved for use in persons 50 years of age or older and persons aged ≥ 2 years who are at increased risk for pneumococcal disease.
","Vaccines, Anti-sera & Immunoglobulin
","Pneumococcal Vaccine induces type-specific antibodies that enhanced opsonization, phagocytosis, and killing of pneumococci by leukocytes and other phagocytic cells. The levels of antibodies that correlate with protection against pneumococcal disease have not been clearly defined.
","Preparation:
+
+- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. If either of these two conditions exists, the vaccine should not be administered.
+- Do not mix Pneumococcal Vaccine with other vaccines in the same syringe or vial.
+- Use a separate sterile syringe and needle for each individual patient to prevent transmission of infectious agents from one person to another.
+
+
Single-Dose Vial: Withdraw 0.5 mL from the vial using a sterile needle and syringe free of preservatives, antiseptics, and detergents.
Single-Dose, Prefilled Syringe: The package does not contain a needle. Attach a sterile needle to the prefilled syringe by twisting in a clockwise direction until the needle fits securely on the syringe.
Administration:
Administer Pneumococcal Vaccine intramuscularly or subcutaneously into the deltoid muscle or lateral mid-thigh. Do not inject intravascularly or intradermally.
Single-Dose Vial: Administer a single 0.5-mL dose of Pneumococcal Vaccine using a sterile needle and syringe. Discard vial after use.
Single-Dose, Prefilled Syringe: Administer the entire contents of the single-dose, prefilled syringe per standard protocol using a sterile needle. Discard syringe after use.
Revaccination: The Advisory Committee on Immunization Practices (ACIP) has recommendations for revaccination against pneumococcal disease for persons at high risk who were previously vaccinated with Pneumococcal Vaccine. Routine revaccination of immunocompetent persons previously vaccinated with a 23-
valent vaccine, is not recommended.
",,"Concomitant Administration with Other Vaccines: In a randomized clinical study, a reduced immune response to ZOSTAVAX as measured by gpELISA was observed in individuals who received concurrent administration of Pneumococcal Vaccine and ZOSTAVAX compared with individuals who received these vaccines 4 weeks apart. Consider administration of the two vaccines separated by at least 4 weeks. Limited safety and immunogenicity data from clinical trials are available on the concurrent administration of Pneumococcal Vaccine and vaccines other than ZOSTAVAX.
","Do not administer Pneumococcal Vaccine to individuals with a history of anaphylactic/anaphylactoid or severe allergic reaction to any component of the vaccine.
","The most common adverse reactions, reported in >10% of subjects vaccinated with p neumococcal vaccine for the first time in a clinical trial, were: injection-site pain/soreness/tenderness (60.0%), injection-site swelling/ induration (20.3%), headache (17.6%), injection-site erythema (16.4%), asthenia and fatigue (13.2%), and myalgia (11.9%).
","Pregnancy: All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15- 20%, respectively. Available human data from clinical trials of Pneumococcal Vaccine in pregnancy have not established the presence or absence of a vaccine-associated risk. Developmental toxicity studies have not been conducted with Pneumococcal Vaccine in animals.
Lactation: It is not known whether Pneumococcal Vaccine is excreted in human milk. Data are not available to assess the effects of Pneumococcal Vaccine on the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Pneumococcal Vaccine and any potential adverse effects on the breastfed child from Pneumococcal Vaccine or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to the disease prevented by the vaccine.
","Persons with Moderate or Severe Acute Illness: Defer vaccination with Pneumococcal Vaccine in persons with moderate or severe acute illness.
Persons with Severely Compromised Cardiovascular or Pulmonary Function: Caution and appropriate care should be exercised in administering Pneumococcal Vaccine to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.
Use of Antibiotic Prophylaxis: This vaccine does not replace the need for penicillin (or another antibiotic) prophylaxis against pneumococcal infection. In patients who require penicillin (or another antibiotic) prophylaxis against pneumococcal infection, such prophylaxis should not be discontinued after vaccination with Pneumococcal Vaccine.
Persons with Altered Immunocompetence: Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to Pneumococcal Vaccine.
Persons with Chronic Cerebrospinal Fluid Leakage: Pneumococcal Vaccine may not be effective in preventing pneumococcal meningitis in patients who have chronic cerebrospinal fluid (CSF) leakage resulting from congenital lesions, skull fractures, or neurosurgical procedures.
","Pediatrics: Pneumococcal vaccine is not approved for use in children younger than 2 years of age because children in this age group do not develop an effective immune response to capsular types contained in the polysaccharide vaccine.
Geriatrics: For subjects aged 65 years or older in a clinical study systemic adverse reactions, determined by the investigator to be vaccine-related, were higher following revaccination (33.1%) than following initial vaccination (21.7%). Routine revaccination of immunocompetent persons previously vaccinated with a 23-valent vaccine is not recommended.
",,,,"Store refrigerated at 2° to 8°C. Protect vials from light.
",11
+1557,Polysaccharide Diphtheria Toxoid Conjugate Vaccine,polysaccharide-diphtheria-toxoid-conjugate-vaccine-1557,https://medex.com.bd/attachments/fwtaP8eu6zVTTCgBwIVYQbgsCbMKgo/polysaccharide-diphtheria-toxoid-conjugate-vaccine-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Meningococcal infection,"Polysaccharide Diphtheria Toxoid Conjugate Vaccine is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. This vaccine is approved for use in individuals 9 months through 55 years of age. Menactra does not prevent N meningitidis serogroup B disease.
","Vaccines, Anti-sera & Immunoglobulin
","The presence of bactericidal anti-capsular meningococcal antibodies has been associated with protection from invasive meningococcal disease. Menactra induces the production of bactericidal antibodies specific to the capsular polysaccharides of serogroups A, C, Y and W-135.
","Primary Vaccination:
+
+- Children 9 through 23 months of age: Two doses, three months apart.
+- Individuals 2 through 55 years of age: A single dose.
+
+Booster Vaccination:
+
+- A single booster dose may be given to individuals 15 through 55 years of age at continued risk for meningococcal disease, if at least 4 years have elapsed since the prior dose.
+
",,"When Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) are to be administered to children 4 through 6 years of age, preference should be given to simultaneous administration of the 2 vaccines or administration of Menactra prior to Polysaccharide Diphtheria Toxoid Conjugate Vaccine. Administraton of Menactra one month after Polysaccharide Diphtheria Toxoid Conjugate Vaccine has been shown to reduce meningococcal antibody responses to Menactra
Pneumococcal antibody responses to some serotypes in Prevnar (PCV7) were decreased following co-administration of Menactra and PCV7.
","Severe allergic reaction (eg, anaphylaxis) after a previous dose of a meningococcal capsular polysaccharide-, diphtheria toxoid- or CRM 197-containing vaccine, or to any component of Menactra
","Common (≥10%): solicited adverse events in infants and toddlers 9 and 12 months of age were injection site tenderness, erythema, and swelling; irritability, abnormal crying, drowsiness, appetite loss, vomiting, and fever.
Common (≥10%): solicited adverse events in individuals 2 through 55 years of age who received a single dose were injection site pain, redness, induration, and swelling; anorexia and diarrhea. Other common solicited adverse events were irritability and drowsiness (2-10 years of age), headache, fatigue, malaise, and arthralgia (11-55 years of age).
","Safety and effectiveness of Polysaccharide Diphtheria Toxoid Conjugate Vaccine have not been established in children younger than 9 months of age, pregnant women, nursing mothers, and adults older than 55 years of age.
","Persons previously diagnosed with Guillain-Barre syndrome (GBS) may be at increased risk of GBS following receipt of Menactra. The decision to give Menactra should take into account the potential benefits and risks.
",,,,,"Keep out of the reach and sight of children. Store at +2°C to +8°C. Transportation should also be at +2°C to +8 °C. Do not freeze. Discard solution if frozen. Protect from light.
",10
+1817,Polymyxin B Sulfate,polymyxin-b-sulfate-1817,https://medex.com.bd/attachments/FRhXm9UzMGbqhwxLJqei6YYkZBCigG/polymyxin-b-sulfate-prescribing-information,Other antibacterial preparation,Urinary tract infection,"Acute infections caused by susceptible strains of Pseudomonas aeruginosa:
Polymyxin B Sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of Pseudomonas aeruginosa.
It may be indicated in serious ... Read more
Acute infections caused by susceptible strains of Pseudomonas aeruginosa:
Polymyxin B Sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of Pseudomonas aeruginosa.
It may be indicated in serious infections caused by susceptible strains of the following organisms, when less potentially toxic drugs are ineffective or contraindicated:
+
+- H. influenzae: Specifically meningeal infections
+- Escherichia coli: Specifically urinary tract infections
+- Aerobacter aerogenes: Specifically bacteremia
+- Klebsiella pneumoniae: Specifically bacteremia
+
","Other antibacterial preparation
",,"Intravenous: Dissolve Polymyxin B 500,000 units in 300 to 500 ml solutions for parenteral Dextrose injection 5% for continuous drip.
Intramuscular: Dissolve Polymyxin B 500,000 units in 2 ml 0.9% Sodium Chloride solution. It is not recommended routinely because of severe pain at injection site, particularly in infants and children.
Intrathecal: Dissolve Polymyxin B 500,000 units in 10 ml 0.9% Sodium Chloride solution for 50,000 units per ml dosage unit.
In meningeal infections, Polymyxin B Sulfate should be administered only by the intrathecal route.
For IV route:
+
+- Adult & Children (Normal kidney function): Dose (Units/kg/day) is 15,000-25,000(Not exceed 25,000) and Dosage frequency/Duration is infusions may be given every 12 hours over a period of approximately 60 to 90 minutes.
+- Adult & Children (Renal impairment): Dose (Units/kg/day) is Less than 15,000 and Dosage frequency/Duration is Infusions may be given every 12 hours over a period of approximately 60 to 90 minutes.
+- Infants (Normal kidney function): Dose (Units/kg/day) is Maximum 40,000
+
+For IM route:
+
+- Adult & Children: Dose (Units/kg/day) is 25,000-30,000 and Dosage frequency/Duration is Dose should be reduced in the presence of renal impairment. The dosage may be divided and given at either 4 or 6 hour intervals.
+- Infants (Normal kidney function): Dose (Units/kg/day) is Maximum 40,000
+
+For Intrathecal:
+
+- Children under 2 years of age: Dosage frequency/Duration is 20,000 units once daily, intrathecally for 3 to 4 days or 25,000 units once every other day. Continue with a dose of 25,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal.
+- Adults and children over 2 years of age: 50,000 units once daily for 3 to 4 days, then 50,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal.
+
",,"The concurrent or sequential use of other neurotoxic and/or nephrotox-ic drugs with Polymyxin B sulfate, particularly bacitracin, kanamycin, streptomycin, tobramycin, amikacin, cephaloridine, cephalothin, paromycin, polymyxin E (colistin), neomycin, gentamicin, and vancomycin, Bumetanide, celecoxib, cisplatin, cyclosporine, diclofenac, misoprostol, diphenhydramine, ibuprofen, naproxen, esomeprazole, etodolac, general anesthetic, gentamycin, ketorolac, meloxicam, tenofovir etc should be avoided.
",,"Clostridium difficile associated diarrhea has been reported with use of Polymyxin B. Nephrotixic reactions: Albuminuria, cylinduria, azotemia, and rising blood levels, Neurotoxic reactions: Facial flushing, dizziness progressing to ataxia, drowsiness, peripheral aresthesias (circumoral and stocking glove), apnea due to concurrent use of curariform muscle relaxants, other neurotoxic drugs or inadvertent overdosage, and signs of meningeal irritation with intrathecal administration, e.g., fever, headache, stiff neck. Other reactions occasionally reported: Drug fever, urticaria rash, severe pain at IM injections sites and thrombophelbitis at IV injections sites.
","There are no controlled data in human pregnancy. Safety has not been established during pregnancy. There is no recommendation regarding use during lactation. There is no study on whether it is secreted with human milk.
","Baseline renal function should be done prior to therapy, with frequent monitoring of renal function and blood levels of the drug during parenteral therapy.
",,"Polymyxin-induced toxicity associated with overdose has been reported. Overdose of Polymyxin can result in neuromuscular blockade, which can lead to apnea, muscular weakness, vertigo, transient facial paresthesia, slurred speech, vasomotor instability, visual disturbance, confusion, psychosis and possible respiratory arrest. Overdose can also cause renal failure characterized by decreased urine output and increased serum concentrations of BUN and creatinine. There is no specific antidote for Polymyxin B Sulfate overdose. In case of Polymyxin B Sulfate overdose, the drug should be stopped and symptomatic treatment instituted. Quick diuresis by IV administered mannitol may help to enhance renal clearance of the drug and thus to reduce serum drug levels. Hemodialysis or peritoneal dialysis may help in order to manage renal complications.
",,,"Before reconstitution, do not store above 30°C; and keep away from light and out of the reach of children. After reconstitution or dilution, unused portion must be stored at 2° to 8°C and should be discarded after 72 hours if not used.
",9
+1831,Polygeline + Electrolytes,polygeline-electrolytes-1831,,Intravenous fluid preparations,Hypovolemia,"Polygeline improved hemodynamic stability in patients with hypovolemia due to traumatic injury. The improvement was seen within 1 h (golden hour) of polygeline administration and maintained consistently. Polygeline can be safely administered to patients with traumatic injury to improve hemodynamic parameters ... Read more
Polygeline improved hemodynamic stability in patients with hypovolemia due to traumatic injury. The improvement was seen within 1 h (golden hour) of polygeline administration and maintained consistently. Polygeline can be safely administered to patients with traumatic injury to improve hemodynamic parameters and achieve stability.
This Infusion contains calcium chloride, sodium chloride and potassium chloride that protect the patient from dehydration and electrolyte disorders after any trauma or injury. Appropriate fluid replacement is very essential to restore normal brain activity and other vital functions of the body to promote healing as well as speedy recovery.
In Short term fluid replacement after trauma.
","Intravenous fluid preparations
","This Infusion injection comprises of a combination of medicines. It is given as a short term fluid replacement after trauma. This Infusion works by replenishing the body’s fluid and electrolytes. This injection should be administered under the supervision of a healthcare professional. You should not self administer this injection.
",,,,"Hypersensitivity to any other ingredient of this preparation.
","Some common side effects of this medicine can be injection site reactions such as redness, pain or swelling. If these side effects persist for a longer duration, please consult your doctor.
",,"Before taking this medicine, tell your doctor if you have any other health conditions may be required. Inform your doctor if you are taking any other medicines or if you are pregnant or breastfeeding. It is advised not to consume alcohol after taking this medicine.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",7
+899,Polyethylene Glycol 3350 + Electrolytes,polyethylene-glycol-3350-electrolytes-899,,Osmotic purgatives,Faecal impaction,"For effective relief from constipation and treatment of chronic constipation. Resolving fecal impaction.
","Osmotic purgatives
","Polyethylene Glycol 3350 exerts an osmotic action in the gut, which induces a laxative effect. Polyethylene Glycol 3350 increases the stool volume, which triggers colon motility via neuromuscular pathways. Electrolytes combined with Polyethylene Glycol 3350 are exchanged across the intestinal barrier (mucosa) with serum electrolytes and excreted in fecal water without net gain or loss of sodium, potassium and water.
Sodium chloride is the major extracellular cation. It is important in electrolyte and fluid balance, osmotic pressure control and water distribution as it restores sodium ions. It is used as a source of electrolytes and water for hydration, treatment of metabolic acidosis, priming solution in haemodialysis and treatment of hyperosmolar diabetes. It is also used as diluents for infusion of compatible drug additives.
Sodium bicarbonate raises blood and urinary pH by dissociation to provide bicarbonate ions, which neutralises the hydrogen ion concentration. It also neutralises gastric acid via production of carbon dioxide.
Potassium chloride is a major cation of the intracellular fluid. It plays an active role in the conduction of nerve impulses in the heart, brain and skeletal muscle; contraction of cardiac skeletal and smooth muscles; maintenance of normal renal function, acid-base balance, carbohydrate metabolism and gastric secretion.
","For adults and children aged 12 years and above: (Powder for Suspension)
+
+- Constipation: The dose is 1 sachet daily. This may be increased to 2-3 sachets daily, if required.
+- Fecal Impaction: 8 sachets daily, consumed within 6 hours. A course of treatment for fecal impaction does not normally exceed 3 days.
+- Patients with renal insufficiency: No dosage change is necessary for treatment of either constipation or fecal impaction.
+- Direction of use: Each sachet should be dissolved in 125 ml water. For fecal impaction 8 sachets may be dissolved in 1 litre of water. Store the solution refrigerated and discard any solution not used within 6 hours.
+
+
For adults and children aged 12 years and above: (Oral Solution)
+
+- Constipation: 25 ml of Polyethylene Glycol 3350 and electrolytes oral solution added to 100 ml of water once daily (to make a total volume of 125 ml). This may be increased to 2-3 doses of 25 ml daily (each 25 ml dose added to 100 ml of water), if required according to individual response.
+- Fecal Impaction: 8 doses of 25 ml daily (each 25 ml dose added to 100 ml of water). A course of treatment for fecal impaction does not normally exceed 3 days.
+- Direction of use: 25 ml of oral solution added to 100 ml of water (to make a total volume of 125 ml). Any unused diluted solution should be discarded within 24 hours.
+
",,"No specific drug interactions have been found.
","Polyethylene Glycol 3350 and electrolytes is contraindicated in patients with known hypersensitivity to the active substance or any of the excipients, intestinal perforation or obstruction, crohn’s disease and ulcerative colitis.
","Generally well tolerated. However side effects like allergic reactions, electrolyte disturbances particularly hyperkalaemia and hypokalaemia, abdominal pain, diarrhea, headache, peripheral edema may appear.
","Use in Pregnancy: There is no experience of the use of Polyethylene Glycol 3350 during pregnancy and lactation. It should only be used if considered essential by the physician.
Use in Lactation: It is unknown whether Polyethylene Glycol 3350 is excreted in human breast milk.
","Patients with impaired cardiovascular function: For the treatment of fecal impaction the dose should be divided so that no more than two sachets are taken in any one hour.
If patients develop any symptoms indicating shifts of fluid/electrolytes (e.g. edema, shortness of breath, increasing fatigue, dehydration, cardiac failure) Movilax should be stopped immediately and any abnormality should be treated appropriately. Prolonged use with all laxatives is undesirable and may lead to dependence.
",,"Severe pain or distention can be treated by nasogastric aspiration. Extensive fluid loss by diarrhea or vomiting may require correction of electrolyte disturbances.
",,,"Store below 30° C and in a place protected from light. Do not refrigerate.
",11
+901,Polyethylene Glycol + Propylene Glycol,polyethylene-glycol-propylene-glycol-901,,Drugs for Dry eyes,Dry eye,"This sterile eye drops is indicated for the temporary relief of burning and irritation due to dryness of the eye.
","Drugs for Dry eyes
","The combination of Polyethylene Glycol 400 & Propylene Glycol is clinically proven to reduce both signs and symptoms of dry eye. The mechanism of action is thought to be due to its unique gelling and lubricating system formulated to adjust to each users individual tear pH. When the ingredients of this eye drops combine with natural tears, a soft gel forms a network of protection over the eye surface. Since it promotes a healthy environment in eye surfaces, damaged surface cells of eye can repair more easily.
","Instill 1 drop 4 times daily in the affected eye(s) or as needed.
",,,"It is contraindicated in patients with known hypersensitivity to any ingredient in this formulation.
","Generally well tolerated. This sterile eye drops should not be used if allergic condition occurs to any ingredients of the product.
",,"Never touch the tip of the container with any surface to avoid contamination. Replace cap after each use.
",,,,,"Store in a cool & dry place, protect from light. Do not use longer than one month after the first opening. Keep out of the reach of children
",8
+900,Polyethylene Glycol,polyethylene-glycol-900,,Osmotic purgatives,Osmotic laxative,"Polyethylene Glycol is indicated in the treatment of constipation. This should be used for 2 weeks or less or as directed by physician. Polyethylene Glycol 3350 is a prescription only laxative that has been prescribed by physician to treat constipation. This product should only be used by the person for whom it is prescribed.
","Osmotic purgatives
","The primary mode of action is thought to be through the osmotic effect of polyethylene glycol 3350 which causes water to be retained in the colon and produces a watery stool. Polyethylene Glycol induces as diarrhea which rapidly cleanses the bowel, usually within four hours.
","The usual dose of Polyethylene Glycol is 17 gm of powder per day (or as directed by physician) in a glass of water, juice, coke, coffee or tea. Each bottle of Polyethylene Glycol is supplied with a cup that is used to measure 17 gm or 8.5 gm of laxative powder when filled upto the marked line.
","It should always be taken by mouth. Measure the dose using the supplied cup, stir and dissolve in a glass of water, juice, coke, coffee or tea. Taking more than the prescribed dose may cause loss of fluid due to severe diarrhea.
","No specific drug interactions have been demonstrated.
","Polyethylene glycol is contraindicated in patients with known or suspected bowel obstruction and patients known to be allergic to polyethylene glycol.
","Nausea, abdominal bloating, cramping and flatulence may occur. High doses may produce diarrhea and excessive stool frequency, particularly in elderly nursing home patients. Patients taking other medications containing polyethylene glycol have occasionally developed urticaria suggestive of an allergic reaction.
","Pregnancy: It is not known whether Polyethylene glycol can cause fetal harm when administered to a pregnant woman, or can effect reproductive capacity. Polyethylene glycol should only be administered to a pregnant woman if clearly needed.
Lactation: There is no information on the use of Polyethylene glycol while nursing. Consultation with a physician is necessary in case of breastfeeding.
","Patients with symptoms suggestive of bowel obstruction (nausea, vomiting, abdominal pain or distention) should be evaluated to rule out this condition before initiating Polyethylene Glycol therapy. Polyethylene Glycol should be administered after being dissolved in water, juice, coke, coffee or tea.
",,"There have been no reports of accidental overdosage. In the event of overdosage diarrhea would be the expected major event. If an overdose of drug occurred without concomitant ingestion of fluid, dehydration due to diarrhea may result. Medication should be terminated and free water administered.
","Polyethylene Glycol achieves its best results when used between one and two weeks. It may be discontinued after several satisfactory bowel movements. Should unusual cramps, bloating, or diarrhea occur, consultation with physician is needed. Polyethylene Glycol is intended for up to a two-week course of therapy. It should not be used for a longer time unless directed by a physician. After successfully completing the Polyethylene Glycol therapy (usually between one and two weeks) discussion with a physician is needed to change lifestyle that may produce more regular bowel habits (adequate dietary and fluid intake, regular exercise).
",,,12
+928,Proparacaine Hydrochloride,proparacaine-hydrochloride-928,https://medex.com.bd/attachments/rrnHWQ77xtrjhv5ZqzNWZGbLoO2JV7/proparacaine-hydrochloride-prescribing-information,Ocular perioperative drugs,Tonometry,"Proparacaine is indicated for procedures in which a topical ophthalmic anesthetic is indicated: corneal anesthesia of short duration, e.g. tonometry, gonioscopy, removal of corneal foreign bodies, and for short corneal and conjunctival procedures. It is also indicated for use prior to surgical operations such as cataract extraction.
","Ocular perioperative drugs
","The main site of anesthetic action is the nerve cell membrane where proparacaine interferes with the large transient increase in the membrane permeability to sodium ions that is normally produced by a slight depolarization of the membrane. As the anesthetic action progressively develops in a nerve, the threshold for electrical stimulation gradually increases and the safety factor for conduction decreases; when this action is sufficiently well developed, block of conduction is produced. Several studies indicate that local anesthetics may limit sodium ion permeability by closing the pores through which the ions migrate in the lipid layer of the nerve cell membrane.
","Deep anesthesia as in cataract extraction: Instill 1 drop to the eye every 5 to 10 minutes for 5 to 7 doses.
Removal of sutures: Instill 1 or 2 drops to the eye 2 or 3 minutes before removal of stitches.
Removal of foreign bodies: Instill 1 or 2 drops to the eye prior to operating.
Tonometry: Instill 1 or 2 drops to the eye immediately before measurement.
",,,"Proparacaine eye drops should be considered contraindicated in patients with known hypersensitivity to any of the ingredients of this preparation.
","Occasional temporary stinging, burning and conjunctival redness may occur with the use of Proparacaine.
","Use in pregnancy: It is not known whether Proparacaine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Proparacaine should be administered to a pregnant woman only if clearly needed.
Use in lactation: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Proparacaine is administered to a nursing mother.
","Prolonged use of a topical ocular anesthetic is not recommended. It may produce permanent corneal opacification with accompanying visual loss.
","Pediatric Use: Safety and effectiveness of Proparacaine ophthalmic solution in pediatric patients have been established. Use of Proparacaine is supported by evidence from adequate and well-controlled studies in adults and children over the age of twelve, and safety information in neonates and other pediatric patients.
Geriatric Use: No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.
",,,,"Store bottles under refrigeration at 2° to 8° C & protect from light. It is desirable that the contents should not be used more than 4 weeks after first opening of the bottle. If solution shows more than a faint yellow color, it should not be used. Keep bottle tightly closed.
",10
+927,Propantheline Bromide,propantheline-bromide-927,https://medex.com.bd/attachments/f3se6oh9XgLIaQSEoFbtfFvPozyGQB/propantheline-bromide-prescribing-information,Anticholinergics (antimuscarinics)/ Anti-spasmodics,Peptic ulcer disease,"Propantheline Bromide is indicated in the treatment of-
+
+- Adjunctive therapy in the treatment of peptic ulcer (gastric and duodenal)
+- Relief of the symptoms of gastritis (stomach upset, gastrointestinal bleeding, blood in vomit, blood in stool, persistent pain)
+- Symptomatic treatment of the diarrhoea related irritable bowel syndrome (irritable colon, spastic colon, acute enterocolitis, functional Gl disorders etc)
... Read more
Propantheline Bromide is indicated in the treatment of-
+
+- Adjunctive therapy in the treatment of peptic ulcer (gastric and duodenal)
+- Relief of the symptoms of gastritis (stomach upset, gastrointestinal bleeding, blood in vomit, blood in stool, persistent pain)
+- Symptomatic treatment of the diarrhoea related irritable bowel syndrome (irritable colon, spastic colon, acute enterocolitis, functional Gl disorders etc)
+- Urinary incontinence
+- Control of salivation and enuresis
+- Improves lactose intolerance
+- Prevents excessive sweating (Hyperhidrosis)
+
","Anticholinergics (antimuscarinics)/ Anti-spasmodics
","Propantheline Bromide acts by dual mechanism of action.
+
+- Specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites
+- Direct effect upon smooth muscle (musculotropic).
+
+This medication is a muscarinic antagonist having antispasmodic properties. It reduces the effect of acetylcholine, a chemical released from nerves that stimulates muscles, by blocking the receptors for acetylcholine on smooth muscle. It also has a direct relaxing effect on smooth muscle. In addition, Propantheline inhibits gastrointestinal motility and decreases gastric acid secretion and controls excessive pharyngeal, tracheal and bronchial secretions. Other secretions like pancreatic juice, sweat and saliva are also reduced.
","The usual initial adult dose of Propantheline Bromide is 75 mg daily. One tablet 30 min before each meal (15 mg three times daily). Two tablets at bedtime Dosage adjustment should be made according to the patient's individual response and tolerance. But the maximum daily dosage should not exceed 120 mg.
Pediatric use: Safety and effectiveness in pediatric patients have not been established.
",,"Antacids or Absorbent Antidiarrhoeals may reduce the absorption of propantheline bromide, therefore resulting in a reduction of its therapeutic effectiveness. Therefore, take two to three hours apart from doses of propantheline bromide. Anticholinergics may delay absorption of other medication given concomitantly. Significant drug interaction also occurs with concomitant use of digoxin, haloperidol, corticosteroides, ketoconazole, levodopa, opioid analgesics, phenothiazines, urinary alkalizers.
","Propantheline Bromide is contraindicated in patients with-
+
+- Hypersensitivity to Propantheline bromide or other anticholinergic agents;
+- Glaucoma;
+- Obstructive disease of the gastrointestinal tract (pyloroduodenal stenosis, paralytic ileus etc.);
+- Obstructive uropathy (e.g. prostatic hypertrophy) intestinal atony of elderly;
+- Myasthenia gravis.
+
","The adverse effects of Propantheline Bromide are usually dose-related and are usually reversible when the therapy is discontinued. Variable degrees of dry mouth, dry skin, mydriasis might be noted. Other reported adverse effects include urinary retention, nausea, vomiting, constipation, headache, nervousness, mental confusion etc.
","Propantheline Bromide is in pregnancy category C. Animal reproduction studies have not been conducted with propantheline bromide. Propantheline bromide should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in milk. Because many drugs are excreted in milk, caution should be exercised when propantheline bromide is administered to a nursing woman. Suppression of lactation may occur with anticholinergic drugs.
","Propantheline Bromide should be used with caution in the elderly and in all patients with autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac tachyarrhythmias, hypertension, since anticholinergics may aggravate this condition.
",,"The symptoms of overdosage with Propantheline Bromide progress from an intensification of the usual side effects (from nausea and vomiting) to CNS disturbances (from restlessness and excitement to psychotic behaviour), circulatory changes, (flushing, fall in blood pressure, circulatory failure), respiratory failure, paralysis.
",,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",11
+926,Propafenone Hydrochloride,propafenone-hydrochloride-926,https://medex.com.bd/attachments/gPKkaEXCpp9uo7g1hFCWLh1qoFoZnH/propafenone-hydrochloride-prescribing-information,Membrane stabilizing agent (Sodium channel blockers),Supraventricular and ventricular arrhythmias,"Propafenone is indicated for the treatment of paroxysmal atrial fibrillation/flutter (PAF), paroxysmal supraventricular tachycardia (PSVT). Propafenone is also indicated for the treatment of documented ventricular arrhythmias.
","Membrane stabilizing agent (Sodium channel blockers)
","Propafenone works by slowing the influx of sodium ions into the cardiac muscle cells, causing a decrease in excitability of the cells. Propafenone is more selective for cells with a high rate, but also blocks normal cells more than class Ia or Ib. Propafenone differs from the prototypical class Ic antiarrhythmic in that it has additional activity as a beta-adrenergic blocker which can cause bradycardia and bronchospasm.
","The dose of Propafenone must be individually titrated on the basis of response and tolerance. It is recommended that therapy be initiated with Propafenone 150 mg given every eight hours (450 mg/day). Dosage may be increased at a minimum of 3 to 4 day intervals to 225 mg every 8 hours (675 mg/day) and if necessary, to 300 mg every 8 hours (900 mg/day). The usefulness and safety of dosages exceeding 900 mg per day have not been established.
",,"Propafenone is metabolized by CYP2D6 (major pathway) and CYP1A2 and CYP3A4. Drugs that inhibit CYP2D6 (such as desipramine, paroxetine, ritonavir, sertraline), CYP1A2 (such as amiodarone) and CYP3A4 (such as ketoconazole, ritonavir, saquinavir, erythromycin and grapefruit juice) can be expected to cause increased plasma levels of propafenone. In addition, propafenone is an inhibitor of CYP2D6. Coadministration of propafenone with drugs metabolized by CYP2D6 (such as desipramine, imipramine, haloperidol, venlafaxine) might lead to increase plasma concentrations of these drugs.
","Propafenone is contraindicated in the presence of uncontrolled congestive heart failure, cardiogenic shock, sinoatrial, atrioventricular and intraventricular disorders of impulse generation and/or conduction (e.g. sick sinus node syndrome, atrioventricular block) in the absence of an artificial pacemaker, bradycardia, marked hypotension, bronchospastic disorders, manifest electrolyte imbalance and known hypersensitivity to the drug.
","Adverse reactions associated with propafenone occur most frequently in the gastrointestinal, cardiovascular and central nervous systems. Change in taste, constipation, diarrhea, dizziness, drowsiness, dry mouth, gas, headache, light-headedness, nausea, tiredness etc. may happen. Severe allergic reactions also reported with propafenone.
","Pregnancy: Propafenone has been assigned to pregnancy category C by the FDA. There are no controlled data in human pregnancy. Limited data indicate that propafenone has been administered during the third trimester of pregnancy without adverse maternal or fetal effects. Propafenone should be given during pregnancy only when benefit outweighs risk.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from propafenone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","Hepatic Dysfunction: Propafenone is highly metabolized by the liver and should therefore, be administered cautiously to patients with impaired hepatic function. As a result, the dose of propafenone given to patients with impaired hepatic function should be approximately 20 to 30% of the dose given to patients with normal hepatic function.
Renal Dysfunction: A considerable percentage of propafenone metabolites (18.5% to 38% of the dose/48 hours) are excreted in the urine. Until further data are available, propafenone should be administered cautiously to patients with impaired renal function.
Neuromuscular Dysfunction: Exacerbation of myasthenia gravis has been reported during propafenone therapy.
","Pediatric Use: The safety and effectiveness of propafenone in pediatric patients have not been established.
Geriatric Use: Clinical studies of propafenone did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious.
",,,,"Store at 25° C. Store in a cool and dry place, protected from light. Keep out of children’s reach.
",11
+925,Promethazine Theoclate,promethazine-theoclate-925,https://medex.com.bd/attachments/on8lxAD1LR4gYbAzlStiV9JCguNNwz/promethazine-theoclate-prescribing-information,Sedating Anti-histamine,Vertigo,"Promethazine Theoclate Tablets are an anti-emetic (anti-sickness drug) which helps to prevent, and treat nausea and vomiting, including travel sickness, and vertigo. Promethazine Theoclate contains promethazine which belongs to a group of medicines called phenothiazines. Your doctor may prescribe this ... Read more
Promethazine Theoclate Tablets are an anti-emetic (anti-sickness drug) which helps to prevent, and treat nausea and vomiting, including travel sickness, and vertigo. Promethazine Theoclate contains promethazine which belongs to a group of medicines called phenothiazines. Your doctor may prescribe this medicine for giddiness or light-headedness (vertigo), or for sickness after an operation, and in such cases the tablets should be taken as instructed by your doctor.
","Anti-emetic drugs, Miscellaneous sedatives & hypnotics, Sedating Anti-histamine
","Promethazine Theoclate works by stopping histamine from binding to its receptors in an area in the brain known as the vomiting centre. The vomiting centre is responsible for causing feelings of sickness and for the vomiting reflex. It is activated when it receives nerve messages from the vestibular apparatus in the middle ear.
The vestibular apparatus provides constant feedback to the brain about the position of our body. When something disturbs the vestibular apparatus, such as movements of the head when travelling by boat or car, nerve signals are sent from the vestibular apparatus to the vomiting centre. This can cause the symptoms of motion sickness, such as nausea, dizziness or spinning sensations (vertigo) and vomiting.
By blocking the histamine receptors in the vomiting centre, Promethazine Theoclate prevents disturbances in the middle ear from activating the vomiting centre.
","To prevent travel sickness on short journeys: Promethazine Theoclate should be taken at least one or two hours before travelling. Adults and children aged over 10 years should take one tablet. Children aged 5 to 10 years should be given half a tablet.
To prevent travel sickness on long journeys: Promethazine Theoclate should be taken at bedtime each night during the journey, starting the night before you travel. Adults and children aged over 10 years should take one tablet. Children aged 5 to 10 years should be given half a tablet.
To treat travel sickness: Adults and children over 10 years should take one tablet as soon as you feel sick, followed by a second tablet the same evening. Take a third tablet the following evening if necessary. Children aged 5 to 10 years should treated in the same way, but with half a tablet each time.
For sickness and vomiting due to other causes, and for treating vertigo: Adults and children aged over 10 years should take one tablet up to three times a day. Children aged 5 to 10 years should be given half a tablet up to three times a day. Alternatively you should follow the instructions given by your doctor.
",,"It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start taking Promethazine Theoclate. Similarly, check with your doctor or pharmacist before taking any new medicines while taking Promethazine Theoclate, to make sure that the combination is safe.
Promethazine Theoclate should not be taken by anyone who has taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI), eg phenelzine, tranylcypromine, isocarboxazid, in the previous 14 days.
You are more likely to feel drowsy if you take Promethazine Theoclate with any of the following (which can also cause drowsiness):
+
+- alcohol
+- antipsychotic medicines, eg chlorpromazine
+- barbiturates, eg phenobarbital
+- benzodiazepines, eg diazepam, temazepam
+- sedating antihistamines, eg chlorphenamine, brompheniramine, hydroxyzine
+- sleeping tablets, eg zopiclone
+- strong opioid painkillers, eg morphine, codeine, dihydrocodeine, tramadol
+- tricyclic antidepressants, eg amitriptyline.
+
","
+- Children under five years of age.
+- People with reduced awareness, slow reactions or extreme drowsiness caused by medicines or illnesses that reduce activity in the central nervous system.
+- People who have taken a type of medicine called a monoamine-oxidase inhibitor antidepressant (MAOI) in the past 14 days.
+- Children and adolescents who have signs and symptoms suggestive of Reye's syndrome.
+- People who are allergic to any ingredients of the tablets.
+- Promethazine Theoclate tablets contain lactose and should not be taken by people with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
+
","Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with promethazine. Just because a side effect is stated here does not mean that all people using Promethazine Theoclate will experience that or any side effect.
+
+- Drowsiness or feeling tired.
+- Dizziness.
+- Restlessness.
+- Headache.
+- Nightmares.
+- Blurred vision.
+- Difficulty passing urine.
+- Dry mouth.
+- Confusion.
+- Feeling disorientated.
+- Unexpected increase in excitability in children.
+- Increased sensitivity of the skin to sunlight (photosensitivity). If affected you should avoid sun lamps and direct sunlight while you are taking this medicine.
+- Loss of appetite.
+- Awareness of your heartbeat (palpitations).
+- Abnormal heartbeats (arrhythmias).
+- Low blood pressure (hypotension).
+- Abnormal movements of the hands, legs, face, neck and tongue, eg tremor, twitching, rigidity (extrapyramidal effects).
+- Blood disorders.
+
","If you are pregnant you should not take Promethazine Theoclate without consulting your doctor first. Promethazine Theoclate should only be used during pregnancy if essential, and only if the expected benefit to the mother outweighs any potential risks to the developing baby. It should not be used during the last two weeks of pregnancy, because if taken during this time it may cause irritability or excitement in the baby after birth. Seek further medical advice from your doctor.
Small amounts of Promethazine Theoclate may pass into breast milk. This is not expected to be harmful to a nursing infant with occasional short-term use of Promethazine Theoclate, but there is a risk that it may cause drowsiness, irritability or excitement in a newborn baby. If you are breastfeeding you should not take Promethazine Theoclate without getting medical advice from your doctor first.
","Promethazine Theoclate tablets can make some people feel drowsy, dizzy, confused or disorientated and this may reduce your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance. If your child is affected in this way they should avoid potentially hazardous activities such as riding bikes. You should not leave your child unattended after giving them this medicine.
Avoid drinking alcohol while taking Promethazine Theoclate because this is likely to make the above effects more likely or worse.
Promethazine Theoclate tablets may make your skin more sensitive to sunlight than usual, so you should avoid exposing your skin to direct sunlight or sunlamps until you know how your skin reacts. If you can't avoid strong sunlight you should use a sunscreen lotion or make sure your skin is protected with clothing.
This medicine may interfere with some pregnancy tests, causing false negative or false positive results.
If you are due to have any skin prick tests to diagnose allergies you should stop taking Promethazine Theoclate at least 72 hours before the tests. This is because antihistamines can prevent or lessen the skin reactions that indicate an allergy, and so can make the test results unreliable.
",,,,,"Store between 15-30° C. Protect from light.
",10
+1170,Promethazine Hydrochloride (Injection),promethazine-hydrochloride-injection-1170,https://medex.com.bd/attachments/RXU8QaZhkhan77OAksOvAUekmZ7QNa/promethazine-hydrochloride-injection-prescribing-information,Sedating Anti-histamine,Vomiting,"Promethazine hydrochloride injection is indicated for the following conditions:
+
+- Amelioration of allergic reactions to blood or plasma.
+- In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled.
+- For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.
... Read more
Promethazine hydrochloride injection is indicated for the following conditions:
+
+- Amelioration of allergic reactions to blood or plasma.
+- In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled.
+- For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.
+- For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused.
+- Active treatment of motion sickness.
+- Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
+- As an adjunct to analgesics for the control of postoperative pain.
+- Preoperative, postoperative, and obstetric (during labor) sedation.
+- Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.
+
","Anti-emetic drugs, Miscellaneous sedatives & hypnotics, Sedating Anti-histamine
","Promethazine is a phenothiazine derivative which blocks postsynaptic mesolimbic dopaminergic receptors in the brain. It exhibits strong α-adrenergic blocking effect and depresses the release of hypothalamic and hypophyseal hormones. It competes with histamine for the H1-receptor; muscarinic blocking effect may be responsible for antiemetic activity. It also reduces stimuli to the brainstem reticular system.
Clinical effects are generally apparent within 5 minutes of an intravenous injection and within 20 minutes of an intramuscular injection. Duration of action is four to six hours, although effects may persist up to 12 hours. Promethazine hydrochloride injection is metabolized in the liver, with the sulfoxides of promethazine and N-desmethylpromethazine being the predominant metabolites appearing in the urine. Following intravenous administration in healthy volunteers, the plasma half-life for promethazine has been reported to range from 9 to 16 hours. The mean plasma half-life for promethazine after intramuscular administration in healthy volunteers has been reported to be 9.8±3.4 hours.
","Allergic Conditions: The average adult dose is 25 mg. This dose may be repeated within two hours if necessary, but continued therapy, if indicated, should be via the oral route as soon as existing circumstances permit. After initiation of treatment, dosage should be adjusted to the smallest amount adequate to relieve symptoms. The average adult dose for amelioration of allergic reactions to blood or plasma is 25 mg.
Sedation: In hospitalized adult patients, nighttime sedation may be achieved by a dose of 25 to 50 mg of Promethazine Hydrochloride injection.
Nausea and Vomiting: For control of nausea and vomiting, the usual adult dose is 12.5 to 25 mg, not to be repeated more frequently than every four hours. When used for control of postoperative nausea and vomiting, the medication may be administered either intramuscularly or intravenously and dosage of analgesics and barbiturates reduced accordingly.
Preoperative and Postoperative Use: As an adjunct to preoperative or postoperative medication, 25 to 50 mg Promethazine Hydrochloride injection in adults may be combined with appropriately reduced doses of analgesics and atropine-like drugs as desired. Dosage of concomitant analgesic or hypnotic medication should be reduced accordingly.
",,"CNS Depressants: Promethazine hydrochloride (promethazine hydrochloride injection) may increase, prolong, or intensify the sedative action of central-nervous-system depressants, such as alcohol, sedative-hypnotics (including barbiturates), general anesthetics, narcotics, narcotic analgesics, tranquilizers, etc. When given concomitanty with promethazine hydrochloride (promethazine hydrochloride injection), the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine hydrochloride (promethazine hydrochloride injection) relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain.
Epinephrine: Although reversal of the vasopressor effect of epinephrine has not been reported with promethazine hydrochloride (promethazine hydrochloride injection), it is recommended that epinephrine NOT be used in the case of promethazine hydrochloride (promethazine hydrochloride injection) overdose.
","Promethazine hydrochloride injection is contraindicated in comatose states and in patients who have demonstrated an idiosyncrasy or hypersensitivity to promethazine or other phenothiazines. Under no circumstances should Promethazine hydrochloride injection be given by intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene.
Promethazine hydrochloride injection should not be given by the subcutaneous route; evidence of chemical irritation has been noted, and necrotic lesions have resulted on rare occasions following subcutaneous injection. The preferred parenteral route of administration is by deep intramuscularinjection.
","CNS Effects: Drowsiness is the most prominent CNS effect of the drug. Extrapyramidal reactions may occur with high doses; this is almost always responsive to a reduction in dosage. Other reported reactions include dizziness, lassitude, tinnitus, incoordination, fatigue, blurred vision, euphoria, diplopia, nervousness, insomnia, tremors, convulsive seizures, oculogyric crises, excitation, catatonic-like states, hysteria, and hallucinations.
Cardiovascular Effects: Tachycardia, bradycardia, faintness, dizziness, and increases and decreases in blood pressure have been reported following the use of Promethazine hydrochloride injection. Venous thrombosis at the injection site has been reported.
Gastrointestinal Effects: Nausea and vomiting have been reported, usually in association with surgical procedures and combination drug therapy.
Allergic Reactions: These include urticaria, dermatitis, asthma, and photosensitivity. Angioneurotic edema has been reported.
Other Reported Reactions: Leukopenia and agranulocytosis, usually when promethazine has been used in association with other known marrow-toxic agents, have been reported. Thrombocytopenic purpura and jaundice of the obstructive type have been associated with the use of promethazine. The jaundice is usually reversible on discontinuation of the drug. Subcutaneous injection has resulted in tissue necrosis. Nasal stuffiness may occur. Dry mouth has been reported.
","Pregnancy Category C. Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg (approximately 2.1 and 4.2 times the maximum recommended human daily dose) of Promethazine hydrochloride injection . Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats.
There are no adequate and well-controlled studies of Promethazine hydrochloride injection in pregnant women. Because animal reproduction studies are not always predictive of human response, Promethazine hydrochloride injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
","General: Drugs having anticholingeric properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction. Promethazine hydrochloride (promethazine hydrochloride injection) should be used cautiously in persons with cardiovascular disease or impairment of liver function.
Carcinogenesis, Mutagenesis and Impairment of Fertility: Long term animal studies have not been performed to assess the carcinogenic potential of promethazine hydrochloride (promethazine hydrochloride injection), nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility. Promethazine hydrochloride was nonmutagenic in the Ames Salmonella test system.
","Pediatric Patients: Promethazine hydrochloride are contraindicated for children under 2 years of age. In pediatric patients 2 years of age and older, the dosage should not exceed half that of the suggested adult dose. As an adjunct to premedication, the suggested dose is 0.5 mg per lb. of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug. Antiemetics should not be used in vomiting of unknown etiology in pediatric patients
Geriatric Patients (approximately 60 years or older): Since therapeutic requirements for sedative drugs tend to be less in geriatric patients, the dosage should be reduced for these patients.
","Signs and symptoms of overdosage range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, and unconsciousness.
Stimulation may be evident, especially in pediatric patients and geriatric patients. Convulsions may rarely occur. A paradoxical reaction has been reported in pediatric patients receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares.
Atropine-like and symptoms: dry mouth, fixed, dilated pupils, flushing, etc., as well as gastrointestinal symptoms, may occur.
Treatment: Treatment of overdosage is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. Diazepam may be used to control convulsions. Acidosis and electrolyte losses should be corrected. Note that any depressant effects of promethazine hydrochloride (promethazine hydrochloride injection) are not reversed by naloxone.
Avoid analeptics, which may cause convulsions. The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. In the event that vasopressors are considered for the management of severe hypotension which does not respond to intravenous fluids and repositioning, the administration of levarterenol or phenylephrine should be considered. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure. Extrapyramidal reactions may be treated with anticholinergic antiparkinson agents, diphenhydramine, or barbiturates. Oxygen may also be administered. Limited experience with dialysis indicates that it is not helpful.
",,,"Store between 15-30° C. Protect from light.
",12
+1346,Promethazine Hydrochloride,promethazine-hydrochloride-1346,https://medex.com.bd/attachments/UtVw5pZahSG6zNWj5vckjXgeXI1fRF/promethazine-hydrochloride-tablet-prescribing-information,Sedating Anti-histamine,Vasomotor rhinitis,"
+- Potent long-acting antihistamine with additional anti-emetic and sedative/calming effects.
+- Indicated in symptomatic treatment of allergic conditions of the respiratory tract and skin.
+- Sensitization reactions to drug or foreign proteins, anaphylactic reactions.
+- For sedation, allergic rhinitis, urticaria and insomnia.
... Read more
+- Potent long-acting antihistamine with additional anti-emetic and sedative/calming effects.
+- Indicated in symptomatic treatment of allergic conditions of the respiratory tract and skin.
+- Sensitization reactions to drug or foreign proteins, anaphylactic reactions.
+- For sedation, allergic rhinitis, urticaria and insomnia.
+- As an adjunct in pre-operative sedation in surgery and obstetrics.
+- As a paediatric sedative
+
","Anti-emetic drugs, Miscellaneous sedatives & hypnotics, Sedating Anti-histamine
","Promethazine is a phenothiazine derivative which blocks postsynaptic mesolimbic dopaminergic receptors in the brain. It exhibits strong α-adrenergic blocking effect and depresses the release of hypothalamic and hypophyseal hormones. It competes with histamine for the H1-receptor; muscarinic blocking effect may be responsible for antiemetic activity. It also reduces stimuli to the brainstem reticular system.
Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.
","Adults: Initial dose one 25 mg tablet at night; may be increased to two or three 25 mg tablets at night if necessary. In allergic conditions more frequently administration, twice or three times daily, may be necessary, starting with one or two 10 mg tablets and increasing as required.
Elderly: No specific dosage recommendations.
Children: They may be treated more conveniently by the elixir containing 5 mg/5 ml.
As an antihistamine in allergy:
+
+- Children of 2-5 years: 5-15 mg
+- Children of 5-10 years: 10-25 mg
+- In the case where two doses in 24 hours are required, the lower dose stated should be given.
+
+As a sedative:
+
+- Children of 2-5 years: 15-20 mg
+- Children of 5-10 years: 20-25 mg
+- Given as a single night-time dose
+
",,"
+- Promethazine Hydrochloride may enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative or hypnotic, Alcohol should be avoided during drug treatment.
+- Phenergan may interfere with immunologic urine pregnancy tests to produce false-positive or false-negative results.
+- Phenergan should be discontinued at least 72 hours before the start of skin tests using allergen extracts as it may inhibit the cutaneous histamine response thus producing false-negative results.
+
","
+- Promethazine is contraindicated for use in children less than two years of age
+- Hypersensitivity to promethazine or to any of the excipients.
+- Phenergan should not be used in patients who are in a coma or suffering from CNS depression of any cause. It must not be given to neonates or premature infants.
+- Phenergan should be avoided in patients who have been taking monoamine oxidase inhibitors within the previous 14 days
+
","
+- Nervous system disorders: Frequency Unknown: Neuroleptic Malignant Syndrome the elderly are particularly susceptible to the anticholinergic efects and confusion due to Promethazine, somnolence, dizziness, headaches, extrapyramidal efects including muscle spasm, tic-like movements of the head and face. A very serious and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Stop treatment and call your doctor right away if you have high fever, muscle cramps or stifness, dizziness, very bad headache, fast heartbeat, confusion, agitation, hallucinations, or are sweating a lot.
+- Immune System Disorders- Frequency unknown: Allergic reactions, including urticaria, rash, pruritus, and anaphylaxis, have been reported.
+- Skin and Subcutaneous Tissue Disorders- Frequency unknown: Photosensitivity reaction
+- Metabolism and Nutrition Disorders- Frequency unknown: Anorexia
+- Gastrointestinal Disorders- Frequency unknown: Epigastric discomfort, dry mouth
+- Eye Disorders- Frequency unknown: Blurred vision
+- Blood and Lymphatic System Disorders- Frequency unknown: Blood dyscrasias including hemolytic anemia, agranulocytosis
+- Renal and Urinary Disorders- Frequency unknown: Urinary retention
+- Psychiatric Disorders- Frequency unknown: Infants, newborns and premature are susceptible to the anticholinergic efects of promethazine, while other children may display paradoxical hyperexcitability, restlessness, nightmares, disorientation
+- Cardiac Disorders- Frequency unknown: Palpitations, arrhythmias
+- Vascular disorders- Frequency unknown: Hypotension
+- Hepatobiliary disorders- Frequency unknown: Jaundice
+- General Disorders and Administration Site Conditions- Frequency unknown: Tiredness
+
+Use this drug only as recommended. Do not exceed the recommended dose. There have been case reports of promethazine abuse. Do not take for longer than 10 days.
","There is epidemiological evidence for the safety of promethazine in pregnancy and animal studies have shown no hazard, nevertheless, it should not be used in pregnancy unless the physician considers it essential. The use of Phenergan is not recommended in the two weeks prior to delivery in view of the risk of irritability and excitement in the neonate. When promethazine has been given in high doses during late pregnancy, promethazine has caused prolonged neurological disturbances in the infant. Promethazine should be used in pregnancy only if the potential benefts to the patient are weighed against the possible risk to the fetus. Promethazine is excreted in breastmilk. There are risks of neonatal irritability and excitement.
","
+- The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of Reye’s syndrome.
+- Promethazine may thicken or dry lung secretions and impair expectoration. It should therefore be used with caution in patients with asthma, bronchitis or bronchiectasis.
+- Use with care in patients with severe coronary artery disease.
+- Use with care in patients with narrow angle glaucoma.
+- Use with care in patients with epilepsy.
+- Use with care in patients with hepatic insufciency.
+- Use with care in patients with renal insufciency.
+- Caution should be exercised in patients with bladder neck obstruction.
+- Caution should be exercised in patients with pyloro-duodenal obstruction.
+
",,"Symptoms of severe over dosage are variable. They are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, while adults may become drowsy and lapse into coma. Convulsions may occur in both adults and children; coma or excitement may precede their occurrence. Tachycardia may develop. Cardiorespiratory depression is uncommon. If the patient is seen soon enough after ingestion, it should be possible to induce vomiting with ipecacuanha despite the antiemetic efect of promethazine; alternatively, gastric lavage may be used. Treatment is otherwise supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with diazepam or other suitable anticonvulsant.
",,,"Protect from light. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician
",11
+1637,Progesterone (Vaginal Pessary),progesterone-vaginal-pessary-1637,,Corticosteroid,Premenstrual syndrome,"Micronized Progesterone is indicated in-
+
+- Luteal phase support as part of an Assisted Reproductive Technology (ART) treatment for women.
+- Treatment of premenstrual syndrome, including premenstrual tension and depression.
+- Treatment of puerperal depression.
+
","Corticosteroid, Other Topical corticosteroids
","Micronized Progesterone Vaginal Pessary is structurally and biologically identical to natural endogenous progesterone.
+
+- Absorption: Vaginal administration of Progesterone 400 mg every 12 h in healthy women has been shown effective in rapidly achieving and maintaining serum progesterone concentrations at physiological levels appropriate to the mid-luteal phase of the ovarian cycle and early pregnancy.
+- Distribution: Progesterone is approximately 96 % to 99 % bound to serum proteins, primarily to serum albumin and corticosteroid binding globulin.
+- Biotransformation: Progesterone is metabolized primarily by the liver largely to pregnanediols and pregnanolones. Pregnanediols and pregnanolones are conjugated in the liver to glucuronide and sulfate metabolites. Progesterone metabolites that are excreted in the bile may be deconjugated and may be further metabolized in the gut via reduction, dehydroxylation and epimerization.
+- Elimination: Progesterone undergoes renal and biliary elimination.
+
","For luteal phase support as part of an ART treatment: 400 mg administered vaginally twice a day starting at oocyte retrieval. The administration of Progesterone should be continued for 38 days, if pregnancy has been confirmed.
For maintenance of Pregnancy in cases of Threatened or recurrent abortion: 200 to 400 mg per day in divided doses.
For the treatment of premenstrual syndrome and puerperal depression: 200 mg daily to 400mg twice a day, by vaginal or rectal insertion. For premenstrual syndrome commence treatment on day 14 of menstrual cycle and continue treatment until onset of menstruation. If symptoms are present at ovulation commence treatment on day 12.
",,"Drugs known to induce the hepatic cytochrome-P450-3A4 system (e.g. rifampicin, carbamazepine or phenytoin) may increase the elimination rate and thereby decrease the bioavailability of progesterone. The effect of concomitant vaginal products on the exposure of progesterone from Micronized Progesterone has not been assessed and is therefore not recommended.
","
+- Hypersensitivity to the active substance or to any of the excipients
+- Undiagnosed vaginal bleeding
+- Known or suspected progesterone sensitive malignant tumors Porphyria
+- Severe hepatic dysfunction or disease
+- Known missed abortion or ectopic pregnancy
+- Active arterial or venous thromboembolism or severe thrombophlebitis or a history of these events
+
","Micronized Progesterone is devoid of estrogenic, androgenic and mineralocorticoid effects. Mild somnolence and other CNS side effects like depression, breast tenderness and bloating are reported. Side effects are less when vaginal route is used.
",,"Micronized Progesterone is not indicated in threatened miscarriage. Treatment should be discontinued in the event of a missed miscarriage. Micronized Progesterone should be discontinued if any of the following conditions are suspected: Myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism (venous thromboembolism or pulmonary embolism), thrombophlebitis or retinal thrombosis.
","Renal impaired patient: There is no experience with the use of Progesterone in patients with impaired liver or renal function.
Pediatric population: There is no relevant use of Progesterone in the pediatric population.
Elderly: No clinical data have been collected in patients over age 65.
",,,,"Keep in a cool (below 30°C), dry and dark place. Keep out of the reach of children.
",10
+1597,Progesterone (Vaginal Gel),progesterone-vaginal-gel-1597,https://medex.com.bd/attachments/Dzd8rDGjwUaoALruCIDOp6LPgWNDNZ/progesterone-vaginal-gel-prescribing-information,Drugs for Infertility,Infertility,"This gel contains a hormone called progesterone. When the gel is inserted into your vagina, the progesterone is slowly released into your bloodstream throughout the day. Progesterone is used to give you extra progesterone in the treatment of infertility due to incorrect levels of progesterone during ... Read more
This gel contains a hormone called progesterone. When the gel is inserted into your vagina, the progesterone is slowly released into your bloodstream throughout the day. Progesterone is used to give you extra progesterone in the treatment of infertility due to incorrect levels of progesterone during the menstrual cycle or when you are having an assisted fertility procedure. This is to help you get pregnant. You may also be asked to continue using Progesterone to support your new pregnancy.
","Drugs for Infertility
",,"Insert the contents of one applicator of Progesterone into your vagina each day, starting after your doctor tells you that you have ovulated, or on the 18 th -21 st day of your menstrual cycle. (The first day of your menstrual cycle is the day your period starts.)
When used during in-vitro fertilisation, from the day of the embryo transfer, insert the contents of one applicator of Progesterone into your vagina each day, preferably in the morning. Once tests confirm that you are pregnant, you may be asked to keep using Progesterone to support your new pregnancy- for a total of 30 days.
The applicator is designed in such a way that an exact amount of gel (1.125 g, containing 90 mg progesterone) is delivered. It is expected that a small amount of gel will be left in the applicator. This can be thrown away as you will have received all of the medicine that you need.
","Getting your applicator ready: Grip the applicator by the thick end between your thumb and index finger. Face the thin end of the applicator down to the ground and shake the applicator down to move all the gel inside to the thin end. Grip the applicator by the flat part of the thick end. Twist off and remove the cap from the opposite thin end. To stop the gel from flowing out before use, do not press the air tank at the thick end at this stage.
Inserting your applicator: Lean back or lie down with your knees bent and spread apart. Carefully insert the applicator well into your vagina, until your hand touches your body. Press the air tank at the thick end of the applicator firmly to deliver the gel from the applicator into your vagina.
After using your applicator: Throw away the applicator, including the small amount of gel that is left inside. Use each applicator only once. Progesterone gel can stay in your vagina for several days. You may get a beige to brownish clumpy or cloudy white discharge during this time. This is nothing to worry about.
","Do not use Progesterone at the same time as any other medicines that are inserted into your vagina.
","
+- if you are allergic to the active substance or any of the other ingredients of this medicine.
+- if you have unexplained vaginal bleeding.
+- if you have porphyria (an inability to break down certain substances (porphyrins) in your blood that is passed down in families).
+- if you have or think you might have cancer in your breasts or genital organs.
+- if you have ever had a blood clot due to swollen veins (thrombophlebitis), a blocked blood vessel (thromboembolic disorder) or a stroke.
+- if you are pregnant but your baby has died inside of you (missed abortion).
+
","Common (may affect up to 1 in 10 people):
+
+- headache
+- feeling very tired
+- stomach or gut (gastro-intestinal) cramps
+- breast tenderness
+
","Progesterone is not normally used during pregnancy. However, if you used Progesterone to help you get pregnant, you may be asked to continue using it to support your new pregnancy. The use of Progesterone during breast-feeding is not recommended.
","Caution should be taken
+
+- if you have liver or kidney problems
+- if you have heart problems or diabetes
+- if you have asthma
+- if you have epilepsy or often get migraines
+- if you have ever had depression.
+
","Progesterone is not for use in children or adolescents.
",,,,"Keep this medicine out of the sight and reach of children. Do not store above 25°C. Use each applicator only once. Any gel left in the applicator must be thrown away. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
",11
+924,Progesterone (Capsule),progesterone-capsule-924,https://medex.com.bd/attachments/IglXWjhsY4O7p8nwT60h6h5lhUVNRS/progesterone-capsule-vaginal-insert-prescribing-information,Female Sex hormones,Recurrent miscarriage,"Progesterone softgel capsule is indicated in-
+
+- Maintenance of Pregnancy in cases of Threatened / Recurrent abortion.
+- Luteal support during IUI and ART procedures IVF-ET.
+- Luteal support in cases of proven luteal phase insufficiency.
+- Along with estrogen in post-menopausal hormone replacement therapy (HRT) either in sequential or in continuous regimen.
... Read more
Progesterone softgel capsule is indicated in-
+
+- Maintenance of Pregnancy in cases of Threatened / Recurrent abortion.
+- Luteal support during IUI and ART procedures IVF-ET.
+- Luteal support in cases of proven luteal phase insufficiency.
+- Along with estrogen in post-menopausal hormone replacement therapy (HRT) either in sequential or in continuous regimen.
+- To prevent endometrial hyperplasia where endogenous estrogen is present.
+- As progesterone challenge test in secondary amenorrhoea.
+- For cycle control along with estrogen therapy.
+- Dysfunctional uterine bleeding (DUB)
+- Premenstrual tension.
+- Endometriosis.
+- Oocyte donation programme.
+- Benign mastopathy.
+
","Drugs for menopausal symptoms: Hormone replacement therapy, Female Sex hormones, Oral Contraceptive preparations
","Progesterone softgel capsule contains micronised progesterone, which is structurally and biologically identical to natural endogenous progesterone. Micronisation increases the bioavailability of progesterone. When micronised progesterone is administered after meals, maximal serum progesterone levels are significantly increased. Progesterone concentrations in the endometrial and breast tissue attain high level. Progesterone is approximately 96%-99% bound to serum proteins, primarily to serum albumin (50%-54%). Progesterone is metabolized to pregnanediols and pregnanolones in the liver. The glucuronide and sulfate conjugates of pregnanediol and pregnanolone are excreted in the bile and urine. Progesterone metabolites, which are excreted in bile, may undergo enterohepatic circulation.
","The usual recommended dose: Progesterone 100 mg/200 mg 2 to 3 soft gel capsules daily by the oral or vaginal routes in divided doses. Flexible dosage regimen can be followed depending on the indication and requirements of patients.
Maintenance of Pregnancy in cases of Threatened / Recurrent abortion: Progesterone 200 to 400 mg per day in divided doses.
In-vitro fertilization and embryo transfer: Progesterone 200 mg thrice a day from the day of embryo transfer till pregnancy is confirmed. If pregnant, it is continued till 12th week of pregnancy.
HRT: In sequential regimen: Progesterone 200mg daily for 12 days in last 2 weeks of each therapeutic cycle. In continuous regimen: Progesterone 100 mg daily throughout the month along with estrogen.
Oocyte donation program: Progesterone 100mg twice daily from the day of transfer till pregnancy is confirmed. This may be increased to a maximum of 600 mg per day and continued till 12th week of pregnancy.
Luteal support: Progesterone 100 mg thrice a day from the 17th day of the cycle for 10 days in induced cycle. If pregnant, it is continued till 12th week of pregnancy.
Luteal phase insufficiency: Progesterone 100 mg thrice daily to be continued up to 12 weeks of pregnancy, increasing the dose by 100 mg/day/week to a maximum of 600 mg/day in divided doses if required.
In secondary amenorrhoea: Progesterone 300mg for 10 days results in withdrawal bleeding in 80% of cases.
Premenstrual syndrome: Progesterone 100-200 mg daily for 10 days from 17th to 26th day of each menstrual cycle.
Benign mastopathy: Progesterone 200-300 mg for 10 days per month, usually from 17th to 26th day of the monthly cycle.
",,"Ketoconazole inhibits the metabolism of progesterone.
","Hypersensitivity, hepatic dysfunction, undiagnosed vaginal bleeding, porphyria, cancers of uterus and genital organs, breast cancers, history of stroke or blood clots. It should not be used in a case of miscarriage and tissue left in the uterus.
","Progesterone is devoid of estrogenic, androgenic and mineralocorticoid effects. Mild somnolence and other CNS side effects like depression, breast tenderness and bloating are reported. Side effects are less when vaginal route is used.
",,"Severe renal insufficiency, diabetes mellitus, seizures, migraine, headache, heart diseases, depression.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+923,Procyclidine Hydrochloride,procyclidine-hydrochloride-923,https://medex.com.bd/attachments/Fh8noy3qrqyDMe5sKHwmYBvSNXq1mu/procyclidine-hydrochloride-prescribing-information,Antiparkinson drugs,Sialorrhea,"Procyclidine is used for the adjunctive treatment of all forms of parkinsonian syndrome. It is mainly used for the symptomatic treatment of idiopathic (paralysis agitants), postencephalitic and arteriosclerotic parkinsonian. It is used to control troublesome extrapyramidal symptoms including pseudoparkinsonian ... Read more
Procyclidine is used for the adjunctive treatment of all forms of parkinsonian syndrome. It is mainly used for the symptomatic treatment of idiopathic (paralysis agitants), postencephalitic and arteriosclerotic parkinsonian. It is used to control troublesome extrapyramidal symptoms including pseudoparkinsonian, acute dystonic reactions and akathisia induced by neuroleptic drugs such as phenothiazine derivatives.
","Antiparkinson drugs
","Procyclidine hydrochloride is an antimuscarinic antiparkinsonian agent of relatively low toxicity. It is a synthetic tertiary amine. This drug exerts their antiparkinsonian effect by correcting the relative cholinergic excess which is thought to occur in parkinsonian as a result of dopamine deficiency. It is absorbed from G.I. tract and disappears rapidly from the tissues. After intravenous administration, it acts within 5 to 20 minutes and has a duration of effect up to 4 hours.
","Tablet: This is administered orally, preferably after meals.
+
+- Parkinsonism: Initially 2.5 mg 3 times a day, then 5 mg 3 times a day and occasionally 5 mg at bedtime. The dosage being adjusted as tolerated or until the total daily dose reaches 20 to 30 mg divided into 3 to 4 doses.
+- Drug induced extrapyramidal symptom: Initially 2.5 mg 3 times a day. The dosage being increased by 2.5 mg increment per day as needed and tolerated.
+
+
IM or IV injection: 5-10 mg, repeated if necessary after 20 minutes; maximum 20 mg daily can be given.
",,"The anticholinergic activity of procyclidine may be increased by agents having anticholinergic amantadine. The absorption of ketoconazole may be reduced by concomitant administration of procyclidine.
","It should be given with caution in children and geriatric patients. It is advisable to be cautious in giving Procyclidine to patients with diarrhoea and cardiovascular disease, glaucoma, urinary retention, hepatic or renal impairment. The safety of using procyclidine during pregnancy has not been established. No data are available on the excretion of this drug in breast milk.
","At usual dosage levels dryness of the mouth is generally the only adverse effect. Mydriasis, blurred vision and adverse G.I. effects (nausea, vomiting, epigastric distress, constipation) occur occasionally. An allergic reaction (e.g. rash) or muscular weakness may occasionally occur. High doses may cause vertigo and possibly confusion and hallucination. Adverse effect may usually be minimized by adjustment of dosage and administration after meal.
","The safe use of this drug in pregnancy, lactation or in women of childbearing age requires that the potential benefits be weighed against the possible hazards to the mother and child.
","Precaution should be taken in case of hepatic & renal impairment, children, elderly, pregnancy and lactation condition. Patients with mental disorders occasionally experience a precipitation of a psychotic episode when Procyclidine is administered for the treatment of the extrapyramidal side-effects of neuroleptic. Procyclidine should not be withdrawn abruptly as rebound Parkinsonism symptoms may occur.
","Use in children: Safety and efficacy have not been established in the pediatric age group; therefore the use of Procyclidine hydrochloride is this group requires that the potential benefits be weighed against the possible hazards to children.
",,,,"Protect from light and moisture, store below 25°C. Keep out of the reach of children.
",11
+922,Prochlorperazine Maleate,prochlorperazine-maleate-922,https://medex.com.bd/attachments/rOO3JlGAQ5CkbD3sZGyVxkcFxngx8E/prochlorperazine-maleate-injection-prescribing-information,Anti vertigo drugs,Vomiting,"Prochlorperazine Maleate is indicated-
+
+- To control severe nausea and vomiting caused by radiation therapy, cancer chemotherapy, surgery, and other conditions.
+- Relieving nausea, vomiting, and attacks of dizziness or spinning sensations (vertigo) associated with Meniere's disease and other inner ear disorders.
... Read more
Prochlorperazine Maleate is indicated-
+
+- To control severe nausea and vomiting caused by radiation therapy, cancer chemotherapy, surgery, and other conditions.
+- Relieving nausea, vomiting, and attacks of dizziness or spinning sensations (vertigo) associated with Meniere's disease and other inner ear disorders.
+- For the treatment of psychotic illness such as schizophrenia (hallucinations and hostility).
+- Acute mania.
+- For the short-term treatment of generalized non-psychotic anxiety.
+
","Anti vertigo drugs, Anti-emetic drugs
","Prochlorperazine is a dopamine & histamine antagonist. The mechanism of antiemetic activity is due to the blockade of histamine H, & dopamine D2 neurotransmitter receptors in the chemoreceptor trigger zone and vomiting centre. It also has a weak anticholinergic effect and prevents acid reflux by increasing the tone of the lower oesophageal sphincter.
","Antiemetic-
Children (not recommended in children <10 kg or <2 years):
+
+- 10-14 kg: 2.5 mg every 12-24 hours as needed;maximum: 7.5 mg/day
+- 15-18 kg: 2.5 mg every 8-12 hours as needed;maximum:10 mg/day
+- 19-39 kg: 2.5 mg every 8 hours or 5 mg every 12 hours as needed; maximum: 15 mg/day.
+
+Adults: 5-10 mg 3-4 times/day;usual maximum:40 mg/day
Antipsychotic-
Children (not recommended in children <10 kg or <2 years):
+
+- 2-12 years: 2.5 mg 2-3 times/day
+- Increase dosage as needed to a maximum daily dose of 20 mg for 2-5 years and 25 mg for 6-12 years
+
+Adults: 5-10 mg 3-4 times/day; doses up to 150 mg/day may be required in some patients for treatment of severe disturbances
Nonpsychotic anxiety-
+
+- Adults: Usual dose: 15-20 mg/day in divided doses; do not give doses >20 mg/day or for longer than 12 weeks
+- Elderly: Initial: 2.5-5 mg 1-2 times/day; increase dose at 4 to 7 day intervals by 2.5-5 mg/day; increase dosing intervals (twice daily, thrice daily, etc) as necessary to control response or side effects; maximum daily dose should probably not exceed 75 mg in elderly; gradual increases (titration) may prevent some side effects or decrease their severity.
+
+Prochlorperazine may be administered without regard to the meal.
",,"Alcohol, barbiturate & other sedatives may increase the CNS depressant action. Some drugs like Antacids, antiparkinson's drug, lithium may interfere the absorption of Prochlorperazine. This drug may interfere with the plasma concentration of Propanolol and Phenobarbital.
","Hypersensitivity to prochlorperazine or any component of the formulation, severe CNS
depression; coma; should not be used in children <2 years of age or <10 kg.
","Drowsiness; jaw, neck, and back muscle spasms; fine worm-like tongue movements; rhythmic face, mouth, or jaw movements; slow or difficult speech; difficulty swallowing; restlessness and pacing; tremors; shuffling walk; skin rash; yellowing of the skin or eyes.
","No evidence of adverse effects of this drug has been reported during pregnancy & lactation.
","Caution should be taken while performing tasks that require alertness, such as driving or using machinery. The use of alcohol can cause extreme drowsiness. This medication may increase sensitivity to sunlight. Prolonged sun exposure should be avoided and sunscreen and protective clothing should be taken when anybody is exposed to the sun. This medication can reduce sweating making it more susceptible to heatstroke.
",,"Symptoms of overdose include deep sleep, coma, extrapyramidal symptoms, abnormal involuntary muscle movements, and hypotension.
",,,"Store below 30°C.Protect from light and moisture. Keep out of the reach of children.
",11
+117,Procaine Penicillin + Benzyl Penicillin,procaine-penicillin-benzyl-penicillin-117,,Benzylpenicillin & Phenoxymethyl penicillin,Syphilis,"It is indicated for the treatment or prevention of any infection caused by Penicillin sensitive bacteria where a long acting Penicillin is required. It is indicated in-
+
+- Gonorrhoea caused by Penicillin sensitive microorganisns
+- Prevention of endocarditis during dental procedures
+- Gas-gangrene following amputation
+
","Benzylpenicillin & Phenoxymethyl penicillin
","Benzylpenicillin has a bactericidal action against gram-positive bacteria, gram-negative cocci, some other gram-negative bacteria, spirochetes and actinomycetes. It inhibits final cross-linking stage of peptidoglycan production through binding and inactivation of transpeptidases on the inner surface of the bacterial cell membrane thus inhibiting bacterial cell wall synthesis. It is inhibited by penicillinase and other lactamases.
Interferes with cell wall mucopeptide synthesis during active multiplication, resulting in bactericidal activity against susceptible microorganisms.
","Add 3 ml of water for injection and shake vigorously.
Adults: 4,00,000 units once daily or twice daily.
Children: Over 25 kg as for adults; under 25 kg reduce proportionally. In severe cases dose may be doubled.
Intramuscular injection is the only route of administration of Procaine Penicillin.
","This should be injected IM into the buttocks, thigh, deltoid or triceps muscle. In case continuous injection is necessitated, the injection site should be changed every time.
","Potentially hazardous interactions: invitro Penicillin inactivates Amino- glycosides, so that they should not be mixed in infusion fluids.
","Hypersensitivity to penicillin.
","Allergic reactions may occur but usually resolve on cessation of therapy.
","Pregnancy Category B. Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect that was not confirmed in controlled studies in women in the 1st trimester.
","Hypersensitivity to cephalosporins. Renal impairment. CHF. Infant. Elderly.
",,,,"Add about 8 ml of sterile water for injection to the vial and shake vigorously to make a homogenous suspended solution.
","Store at room temperature.
",12
+1824,Probiotic Combination [9 Billion],probiotic-combination-9-billion-1824,,,Irritable bowel syndrome (IBS),"This is indicated for the management of gastrointestinal problems e.g. IBS, constipation, flatulence, indigestion, etc.
","Probiotic
","The antimicrobial activity of probiotics is thought to be accounted for, in large part, by their ability to colonize the colon and reinforce the barrier function of the intestinal mucosa. In addition, some probiotics have been found to secrete antimicrobial substances known as bacteriocins. It reduced gastrointestinal pH through stimulation of lactic acid producing bacteria and provides a direct antagonistic action on GI pathogen. Lactobacillus acidophilus, Lactobacillus bulgaricus and Bifidobaterium, have also demonstrated antioxidative ability. Mechanisms include chelation of metal ions (iron, copper), scavenging of reactive oxygen species and reducing activity.
","Adults and children over six years of age: one capsule 2 to 3 times daily or as advised by a physician.
",,,"Probiotics are contraindicated in those who are hypersensitive to any component of a probiotic-containing product.
","Probiotics are generally well tolerated.
","Should be used with caution or seek the advice of a healthcare professional before use.
",,,,,,"Store below 15°C, cool and dry place, away from direct sun light & moisture. To maintain optimum shelf life and potency store in the refrigerator. Keep the medicine out of reach of children.
",8
+1614,Probiotic Combination [20 Billion],probiotic-combination-20-billion-1614,https://medex.com.bd/attachments/KqG3GWiHIHsumvvWpoaVnQfFS7p1pW/probiotic-combination-20-billion-prescribing-information,,Upper Gl bloating,"The drug is used to support digestive health in patients suffering from diarrhea. The drug restores gut flora and overcomes gut discomfort in individuals on an antibiotic regimen. It also improves IBS (Irritable Bowel Syndrome) related to abdominal pain and bloating.
","Probiotic
","This is a unique freeze-dried probiotic blend of Bifidobacterium Lactis Bl-04, Bifidobacterium Lactis Bi-07, Lactobacillus Acidophilus NCFM and Lactobacillus Paracasei Lpc-37 that provides support to individuals who have high demands on their digestive tract or their immune system due to diarrhea, antibiotic use and stress. Extensive in vitro and in vivo studies support the health benefit of these strains. Has high tolerance to gastrointestinal conditions and strong adhesion to intestinal cell-lines. It has been found to restore and maintain microbiota after antibiotic use. Moreover, it also improves specific immune response.
","1 capsule daily with a meal or as recommended by the physician. In diarrhea and after antibiotic course the duration of the treatment should be 2-4 weeks and in IBS the duration should be 4-12 weeks. In children unable to swallow the capsule- the content of the capsule can be mixed in a glass with water, juice or normal milk to drink.
",,"There is no known drug interaction.
","The drug is contraindicated if patient has any hypersensitivity to it.
","Generally safe for most of the people but some may feel stomach gas and bloating.
","If pregnant or nursing, consult with your physician before using this product.
","Consult your physician before using the product if you are pregnant, nursing or trying to conceive.
",,,,,"Do not store above 25°C. Keep away from light and out of the reach of children.
",10
+1876,Probiotic Combination [14 strains],probiotic-combination-14-strains-1876,,,Stomach upset,"The original multi-strain this probiotic product containing 14 strains of probiotics for everyday use.
This probiotic is a unique multispecies, multi-strain probiotic supplement with 14 strains of beneficial bacteria. This means that this probiotic can deliver high concentrations of beneficial ... Read more
The original multi-strain this probiotic product containing 14 strains of probiotics for everyday use.
This probiotic is a unique multispecies, multi-strain probiotic supplement with 14 strains of beneficial bacteria. This means that this probiotic can deliver high concentrations of beneficial bacteria to the colonisation sites in the gut- and therefore be able to help a more diverse range of digestive disorders.
The beneficial bacteria in this probiotic are cryoprotected during the freeze drying process, which gives two main benefits:
+
+- They are protected from the harsh acid environment of the stomach and are therefore able to colonise the full length of the gastrointestinal tract.
+- The process allows this probiotic to be stored at room temperature without the need for refrigeration.
+
+This probiotic can be used on a continuous basis or for a short period of time, e.g. when taking antibiotics.
Contains soya and milk, used in the fermentation process. Content of milk is at a level that would not affect lactose intolerant sufferers.
","Probiotic
",,"
+- Take 1-2 capsules once or twice daily with food. If taking two or more capsules daily, you may wish to split the dose between two meals
+- This probiotic is a completely safe probiotic, has no contraindications and carries no risk of overdose
+- This probiotic probiotic capsules can be swallowed whole or pulled apart and the contents sprinkled on to food, or mixed in a drink.
+
+If you are taking antibiotics: Take 4 capsules daily, ideally at a different time of the day from the antibiotics
Continue taking for at least 2 weeks after completion of the antibiotic course.
For travellers:
+
+- 2 weeks before travel follow guidelines for general use
+- During travel take 4 capsules daily
+- Continue to take for at least 2 weeks following the end of travel.
+
+Children under 12: Take 1/2 to 1 capsule once or twice daily with food. If you are taking any medications or have any medical conditions please consult your doctor before taking any food supplement.
",,,,,,,,,,,"Keep sealed and store in cool, dry conditions. Can be stored at room temperature without the need for refrigeration. In high, ambient temperatures (25°C+) air-conditioning or refrigeration would be cautionary to assist in maintaining shelf life. Total bacteria count viable until end of the shelf life
",4
+2042,Probiotic Combination [10 Billion],probiotic-combination-10-billion-2042,,,Gastrointestinal disorders,"Supports digestive health and relieves constipation.
","Probiotic
","This probiotic combination is a unique freeze-dried probiotic blend of Lactobacillus Acidophilus NCFM and Bifidobacterium Lactis HN019 that supports digestive. Both the strains have strong binding affinity to Gastric Epithelial Cell and reside there. Extensive in vitro and in vivo studies support the health benefit of these strains.
Lactobacillus Acidophilus NCFM - It is the most researched strain of the Acidophilus species. It has proven effectiveness in many areas of gastrointestinal and general health including diarrhea, antibiotic-associated gut disturbances, Irritable Bowel Syndrome (IBS) and immune function. It improves IBS related pain and bloating. It alleviates diarrhea and antibiotic associated diarrhea in both children and adult. It also improves constipation and lactose intolerance. In addition, it was found effective to improve Immunity.
Bifidobacterium Lactis HN019- It is proven to reduce colonic transit time which effectively relieves occasional constipation. It also significantly modulates gut microflora to ease digestive discomfort. Moreover, it can increase the immunity through enhancing the activity of circulating natural killer (NK) cells in the body
","1 capsule daily with a meal. May be increased up to 2 capsules/day if required. In children unable to swallow the capsule- the content of the capsule can be mixed in a glass with water, juice or normal milk to drink.
",,,,"Generally safe for most of the people but some may feel stomach gas and bloating.
","If pregnant or nursing, consult with your physician before using this product.
","Consult your physician before using the product if you are pregnant, nursing or trying to conceive.
",,,,,"Do not store above 25°C. Protect from moisture and keep away from light and out of the reach of children.
",8
+920,Primaquine Phosphate,primaquine-phosphate-920,https://medex.com.bd/attachments/xBFmn49hvZqxGgR4qPj8fP6HgpwqRJ/primaquine-phosphate-prescribing-information,Anti-malarial drugs,Pneumocystis jiroveci pneumonia,"Primaquine phosphate is indicated for the radical cure (prevention of relapse) of vivax malaria.
","Anti-malarial drugs
","Primaquine is an 8-aminoquinoline antimalarial which eliminates the exoerythrocytic forms of malarial parasite Plasmodium vivax, Plasmodium ovale and Plasmodium falciparum by disrupting mitochondria and binding to DNA.
Primaquine's mechanism of action is not well understood. It may be acting by generating reactive oxygen species or by interfering with the electron transport in the parasite. Also, although its mechanism of action is unclear, primaquine may bind to and alter the properties of protozoal DNA.
","Primaquine phosphate is recommended only for the radical cure of vivax malaria, the prevention of relapse in vivax malaria, or following the termination of chloroquine phosphate suppressive therapy in an area where vivax malaria is endemic. Patients suffering from an attack of vivax malaria or having parasitized red blood cells should receive a course of chloroquine phosphate, which quickly destroys the erythrocytic parasites and terminates the paroxysm. Primaquine phosphate should be administered concurrently in order to eradicate the exoerythrocytic parasites in a dosage of 1 tablet (equivalent to 15 mg base) daily for 14 days.
","Should be taken with food. Take with meals to avoid GI discomfort.
","Enhanced effect with other drugs that prolong the QT interval.
","Acutely ill patients suffering from systemic disease manifested by tendency to develop granulocytopenia (e.g. rheumatoid arthritis, lupus erythematosus). Concurrent use with other potentially haemolytic drugs or depressants of myeloid elements of the bone marrow. Concomitant admin with mepacrine.
","Abdominal pain, gastric distress, nausea, vomiting; methaemoglobinaemia, haemolytic anaemia (in patients with G6PD deficiency), mild anaemia, leucocytosis; HTN, cardiac arrhythmias, prolonged QT interval on ECG, accommodation disturbance. Rarely, leucopenia, agranulocytosis.
","Pregnancy Category C. Safe usage of this preparation in pregnancy has not been established. Primaquine is contraindicated in pregnant women. Even if a pregnant woman is G6PD normal, the fetus may not be. Animal data show toxicity to reproduction.
Lactation: It is not known whether Primaquine is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Primaquine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","Patient with G6PD deficiency, NADH methaemoglobin reductase deficiency. Childn. Pregnancy and lactation.
",,"Symptoms of overdosage of Primaquine phosphate include abdominal cramps, vomiting, burning epigastric distress, central nervous system and cardiovascular disturbances, including cardiac arrhythmia and QT interval prolongation, cyanosis, methemoglobinemia, moderate leukocytosis or leukopenia, and anemia. The most striking symptoms are granulocytopenia and acute hemolytic anemia in G6PD deficient patients. Acute hemolysis occurs, but patients recover completely if the dosage is discontinued.
",,,"Store at 25° C. Protect from light.
",12
+919,Pregabalin,pregabalin-919,https://medex.com.bd/attachments/jzY4aqLTk7Rq3ZqWjnaj3584FlJTfj/pregabalin-prescribing-information,Adjunct anti-epileptic drugs,,"Pregabalin is indicated for:
+
+- Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
+- Postherpetic neuralgia (PHN)
+- Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older
+- Fibromyalgia
+- Neuropathic pain associated with spinal cord injury
... Read more
Pregabalin is indicated for:
+
+- Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
+- Postherpetic neuralgia (PHN)
+- Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older
+- Fibromyalgia
+- Neuropathic pain associated with spinal cord injury
+
+Pregabalin CR tablet is indicated for:
+
+- Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
+- Postherpetic neuralgia (PHN)
+
","Adjunct anti-epileptic drugs, Primary anti-epileptic drugs
","Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). It does not bind directly to GABAA, GABAB or benzodiazepine receptors. Pregabalin binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of Pregabalin has not been fully elucidated, results in animal studies suggest that binding to the alpha2-delta subunit may be involved in Pregabalin's anti-nociceptive and antiseizure effects.
","Neuropathic pain associated with diabetic peripheral neuropathy in adults (DPN): The maximum recommended dose of Pregabalin is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. The maximum recommended dose of Pregabalin CR capsule is 330 mg once daily.
Postherpetic neuralgia in adults (PHN): The recommended dose of Pregabalin is 75 to 150 mg two times a day or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 75 mg two times a day or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day and who are able to tolerate Pregabalin, may be treated with up to 300 mg two times a day or 200 mg three times a day (600 mg/day).
Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 330 mg once daily and who are able to tolerate Pregabalin CR capsule, may be treated with up to 660 mg once daily. In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, dosing above 330 mg/day should be reserved only for those patients who have on-going pain and are tolerating 330 mg daily. The maximum recommended dose of Pregabalin CR capsule is 660 mg once daily.
Management of fibromyalgia in adults: The recommended dose of Pregabalin is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day).
Neuropathic pain associated with spinal cord injury in adults: The recommended dose range of Pregabalin is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate Pregabalin may be treated with up to 300 mg two times a day.
Conversion from Pregabalin capsules to Pregabalin CR capsule tablet: When switching from Pregabalin capsules to Pregabalin CR capsule tablet on the day of the switch, instruct patients to take their morning dose of Pregabalin capsule as prescribed and initiate Pregabalin CR capsule therapy after an evening meal.
Pregabalin tablet total daily dose (dosed 2 or 3 times daily): Pregabalin CR capsule capsule dose (dosed once a day)
+
+- 75 mg/daily: 82.5 mg/day
+- 150 mg/daily: 165 mg/day
+- 225 mg/daily: 247.5 mg/day
+- 300 mg/daily: 330 mg/day
+- 450 mg/daily: 495 mg/day
+- 600 mg/daily: 660 mg/day
+
","Route of administration: Pregabalin is taken in oral route. It can be taken with or without food. Pregabalin CR tablet should be administered after an evening meal. It should be swallowed whole and should not be split, crushed or chewed. If patients miss taking their dose of Pregabalin CR after an evening meal, then they should take their usual dose of Pregabalin CR prior to bedtime following a snack. If they miss taking the dose of Pregabalin CR prior to bedtime, then they should take their usual dose of Pregabalin CR following a morning meal. If they miss taking the dose of Pregabalin CR following the morning meal, then they should take their usual dose of Pregabalin CR at the usual time that evening following an evening meal. When discontinuing both Pregabalin and Pregabalin CR, it should be gradually tapered over a minimum of 1 week.
","Pregabalin is unlikely to be involved in significant pharmacokinetic drug interactions.
","Pregabalin is contraindicated in patients with known hypersensitivity to Pregabalin or any of its components.
","Most common side effects in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain and thinking abnormal (primarily difficulty with concentration/attention). Most common side effects in pediatric patients for the treatment of partial onset seizures are increased weight and increased appetite.
","There are no adequate and well-controlled studies with pregabalin in pregnant women. Pregnant women should be advised of the potential risk to a fetus. Small amounts of pregabalin have been detected in the milk of lactating women. Because of the potential risk of tumorigenicity, breastfeeding is not recommended during treatment with pregabalin.
","Angioedema (e.g., swelling of the throat, head and neck) can occur and may be associated with life threatening respiratory compromise requiring emergency treatment. Pregabalin should be discontinued immediately in these cases. Pregabalin should also be discontinued immediately if hypersensitivity reactions (e.g., hives, dyspnea and wheezing) occur. Antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behavior. Respiratory depression may occur with pregabalin when used with concomitant CNS depressants or in the setting of underlying respiratory impairment. Patients need to be monitored and dosage adjusted as appropriate. Pregabalin may cause dizziness and somnolence and impair patients ability to drive or operate machinery. Increased seizure frequency or other adverse reactions may occur if pregabalin is rapidly discontinued. Pregabalin should be withdrawn gradually over a minimum of 1 week. Pregabalin may cause peripheral edema. Caution should be exercised when coadministering pregabalin and thiazolidinedione antidiabetic agents.
","Use in children and adolescents: Safety and effectiveness in pediatric patients have not been established for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, neuropathic pain associated with spinal cord injury and fibromyalgia. In case of adjunctive therapy for partial onset seizures, safety and effectiveness in pediatric patients below the age of 1 month have not been established. The safety and effectiveness of pregabalin extended-release tablet in pediatric patients have not been established.
","In case of overdose with pregabalin, sign and symptoms are reduced consciousness, depression/anxiety, confusional state, agitation and restlessness. Seizures and heart block have also been reported. There is no specific antidote. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; usual precautions should be observed to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.
",,,"Keep in a cool & dry place (below 30°C), protected from light & moisture. Keep out of the reach of children.
",13
+1324,Prednisolone Acetate,prednisolone-acetate-1324,https://medex.com.bd/attachments/y9jonpy1DB90rJcVIhtYjbwloTRuNz/prednisolone-acetate-prescribing-information,Glucocorticoids,Surgical aid in the anterior segment,"Prednisolone eye drops is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.
","Glucocorticoids
","Prednisolone decreases inflammation by inhibition of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. It suppresses the immune system by reducing the activity and production of the lymphocytes and eosinophils.
","Adult: Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Care should be taken not to discontinue the therapy before completing the course.
Paediatric: Safety and effectiveness in pediatric patients have not been established.
",,"No significant drug interactions have been reported.
","Prednisolone Acetate is contraindicated in viral diseases of the cornea, conjunctiva and known hypersensitivity to any of the ingredients of this preparation or other corticosteroids.
","Elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation and delayed wound healing. Fungal and viral infections of the cornea are particularly may develop coincidentally with long-term applications of steroid.
","Prednisolone Acetate is pregnancy category C. So, this drug should be used during pregnancy only if clearly needed. It is not known whether topical administration of corticosteroids would result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Prednisolone Acetate is administered to a nursing woman.
","Shake the bottle well before use. Prolonged use of corticosteroids may result in damage to the optic nerve and defects in vision. If this product is used for longer period of time, intraocular pressure should be routinely monitored.
",,"A one-time accidental overdose of Prednisolone Ophthalmic Suspension generally will not cause acute problems. Long time overdose may show general side-effects. In accidental overdose sufficient water should be taken to dilute the medication.
",,,"Store in a cool, dry place and protect from light. Keep out of the reach of children. Protect from freezing. Shake well before using.
",11
+838,Prednisolone + Neomycin Sulphate + Polymixin B Sulphate,prednisolone-neomycin-sulphate-polymixin-b-sulphate-838,,Ophthalmic steroid - antibiotic combined preparations,Steroid-responsive inflammatory ocular conditions,"This is indicated for steroid-responsive inflammatory ocular conditions where bacterial infection or a risk of bacterial ocular infection exists.
","Ophthalmic steroid - antibiotic combined preparations
","Prednisolone decreases inflammation by inhibition of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. It suppresses the immune system by reducing the activity and production of the lymphocytes and eosinophils.
Neomycin: Interferes with bacterial protein synthesis by binding to 30S ribosomal subunits.
Polymixin B Sulphate: Bactericidal; causes leakage of bacterial membrane
","Adult Use: Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Care should be taken not to discontinue the therapy before completing the course.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
",,"Synergistic effects with penicillins. Additive toxicity with neurotoxic, ototoxic or nephrotoxic drugs. May decrease absorption of digoxin and methotrexate. May increase effects of oral anticoagulants.
","Prednisolone Acetate is contraindicated in viral diseases of the cornea, conjunctiva and known hypersensitivity to any of the ingredients of this preparation or other corticosteroids.
","Elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation and delayed wound healing.
Fungal and viral infections of the cornea are particularly may develop coincidentally with long-term applications of steroid
","Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","This combination should be used with caution in patients with known hypersensitivity to the components of this preparation. Prolonged use of corticosteroids may result in damage to the optic nerve and defects in vision. If this product is used for longer period of time, intraocular pressure should be routinely monitored.
",,,,,,9
+1903,Rabies Immunoglobulin,rabies-immunoglobulin-1903,,"Vaccines, Anti-sera & Immunoglobulin",Active immunisation against rabies,"For the seroprophylaxis (prevention by injecting antibodies) of rabies in subjects suspected to have been exposed to the rabies virus, particularly in the event of severe exposure e.g.:
+
+- Multiple transdermal bites or scratches
+- Contamination of mucous membrane with saliva
+- Severe bites located on the face, head, neck and hands
... Read more
For the seroprophylaxis (prevention by injecting antibodies) of rabies in subjects suspected to have been exposed to the rabies virus, particularly in the event of severe exposure e.g.:
+
+- Multiple transdermal bites or scratches
+- Contamination of mucous membrane with saliva
+- Severe bites located on the face, head, neck and hands
+- When the domestic or wild animal responsible cannot be examined or is infected or suspected to be infected by the rabies virus
+- Bites to young children
+
+Rabies Immunoglobulin provides passive immunization against rabies for prevention of rabies in patients after contact with a rabid animal or an animal presumed to be rabid. Anti rabies serum itself does not constitute an anti-rabies treatment and should always be used in conjunction with rabies vaccine.
","Vaccines, Anti-sera & Immunoglobulin
",,"First-aid treatment: Prompt local treatment of bite wounds and scratches that may be contaminated with rabies virus is important, whatever the time elapsed since the contact. The recommended first-aid measures consist of immediate flushing and washing of the wound with soap and water, detergent or other substance of proven lethal effect on rabies virus. The rabies immune globulin should be injected as soon as possible after exposure.
The recommended dose for both adults and children is 40 IU/kg of body weight. If anatomically feasible, as much as possible of the dose should be infiltrated around and into the wound(s). The remainder should be administered intramuscularly (into the gluteal region) in a single injection.
However, for children, particularly in the case of multiple wounds, it has been proposed to dilute the dose 2-3 times in a 0.9% sodium chloride solution to obtain a sufficient quantity of equine rabies immune globulin to infiltrate the wound(s) correctly. Wounds in certain anatomical sites (fingertips) should be infiltrated with care so as to prevent a local increase in pressure in the tissue.
For prevention of rabies, combined immune globulin-vaccine treatment is recommended. The 1st dose of the rabies vaccine should be given at the same time as the Rabies immunoglobulin, but in different parts of the body. If Rabies immunoglobulin is not available when the rabies vaccine is administered, it can be administered up to the 7th or 8th day after the first dose of rabies vaccine. When indicated, begin anti-tetanus treatment and administer anti-microbial drugs to control infections other than rabies.
The WHO expert committee on rabies has issued the following therapeutic recommendations:
Category Type of contact with a suspect or confirmed rabid domestic or wild animal or animal not available for observation Recommended Treatment:
+
+- Touching or feeding, licks on intact skin None, if reliable case history is available
+- Nibbling of uncovered skin, minor scratches superficial bites (except on head, neck, shoulder girdle, arms or hands) or abrasions without bleeding, licks on broken skin. Administer vaccine immediately on Day 0, D3, D7, D14 and D28. Stop treatment if animal remains healthy throughout the observation period of 10 days or if animal is killed humanely and found to be negative by appropriate laboratory techniques.
+
+Single or multiple transdermal bites or scratches specially on head, neck, shoulder girdle,arms or hands. Contamination of mucus membrane with saliva (i.e. licks on broken skin). Administer rabies vaccine immediately on Day 0, D3, D7, D14 and D28 or D90 (optional) and rabies immune globulin on D0 immediately. Stop treatment if animal remains healthy throughout the observation period of 10 days or if animal is killed humanely and found to be negative by appropriate laboratory techniques.
",,,"Known history of allergic symptoms to horse proteins. Nevertheless, the lethal risk associated with rabies overcomes any potential contraindication.
","Immediate or delayed hypersensitive type reactions may be developed on administration of rabies immune globulin. The observed immediate reactions are hypotension, dyspnoea, and urticaria. Delayed reactions consist of inflammatory reaction, fever, pruritis, rash or urticaria, adenopathy and arthralgia.
","The safety of rabies immune globulin when used during pregnancy has not been established in clinical trials in human beings. Considering the lethal risk associated with rabies, pregnancy may not be a contraindication to the administration of rabies immune globulin subsequent to exposure.
","Do not administer rabies immunoglobulin intravenously (due to the risk of shock i.e., sudden collapse with drop in blood pressure). Consequently, make sure that the needle has not penetrated a blood vessel. Rabies immunoglobulin should not be administered in repeated doses. Once the vaccine treatment has been started, repeating injections of rabies immunoglobulin may reduce the protective efficacy that must be guaranteed by the vaccine. Shake well before use. Do not shake vigorously.
",,"If the recommended dosage is not strictly observed, there is a risk of immunosuppressive interference (suppression of immune defenses) with rabies vaccine.
",,,"Keep out of the reach and sight of children. Store at 2°C to 8°C. Transportation should also be at 2°C to 8°C. Protect from light. Do not freeze.
",9
+942,Rabeprazole Sodium,rabeprazole-sodium-942,https://medex.com.bd/attachments/fh7METQXr9zPVCRrH4EvsUjzlSVEkO/rabeprazole-sodium-tablet-prescribing-information,Proton Pump Inhibitor,Gastric ulcer,"Rabeprazole Gastro-resistant tablets are indicated for the treatment of:
+
+- Active duodenal ulcer
+- Active benign gastric ulcer
+- Symptomatic erosive or ulcerative gastro-esophageal reflux disease (GERD).
+- Gastro-esophageal Reflux Disease Long-term Management (GERD Maintenance)
... Read more
Rabeprazole Gastro-resistant tablets are indicated for the treatment of:
+
+- Active duodenal ulcer
+- Active benign gastric ulcer
+- Symptomatic erosive or ulcerative gastro-esophageal reflux disease (GERD).
+- Gastro-esophageal Reflux Disease Long-term Management (GERD Maintenance)
+- Symptomatic treatment of moderate to very severe gastro-esophageal reflux disease (symptomatic GERD)
+- Zollinger-Ellison Syndrome
+- In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori in patients with peptic ulcer disease.
+
","Proton Pump Inhibitor
","Rabeprazole suppresses gastric acid secretion by inhibiting the gastric H+/K+-ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, Rabeprazole has been characterized as a gastric proton-pump inhibitor.
","Active Duodenal Ulcer and Active Benign Gastric Ulcer: The recommended oral dose for both bioactive duodenal ulcer and active benign gastric ulcer is 20 mg to be taken once daily in the morning. Most patients with active duodenal ulcer heal within four weeks. However, a few patients may require an additional four weeks of therapy to achieve healing. Most patients with active benign gastric ulcer heal within six weeks. However, again a few patients may require an additional six weeks of therapy to achieve healing.
Erosive or Ulcerative Gastro-Esophageal Reflux Disease (GERD): The recommended oral dose for this condition is 20 mg to be taken once daily for four to eight weeks.
Gastro-Esophageal Reflux Disease Long-term Management (GERD Maintenance): For long-term management, a maintenance dose of rabeprazole sodium 20 mg or 10 mg once daily can be used depending upon patient response.
Symptomatic treatment of moderate to very severe Gastro-Esophageal Reflux Disease (symptomatic GERD): 10 mg once daily in patients without oesophagitis. If symptom control has not been achieved during four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen taking 10 mg once daily when needed.
Treatment of GERD in pediatric patients 1 to 11 years of age (Less than 15 kg): 5 mg once daily for 12 weeks with the option to increase to 10 mg if inadequate response.
Treatment of GERD in pediatric patients 1 to 11 years of age (15 kg or more): 10 mg once daily for 12 weeks.
Zollinger-Ellison Syndrome: The recommended adult starting dose is 60 mg once a day. The dose may be titrated upwards to 120 mg/day based on individual patient needs. Single daily doses up to 100 mg/day may be given. 120 mg dose may require divided doses, 60 mg twice daily. Treatment should continue for as long as clinically indicated.
Eradication of H. pylori: Patients with H. pylori infection should be treated with eradication therapy. The following combination given for 7 days is recommended. Rabeprazole sodium 20 mg twice daily, clarithromycin 500 mg twice daily and amoxicillin 1g twice daily.
","For indications requiring once-daily treatment Rabeprazole tablets should be taken in the morning, before eating; and although neither the time of day nor food intake was shown to have any effect on rabeprazole sodium activity, this regimen will facilitate treatment compliance. Patients should be cautioned that the Rabeprazole tablets should not be chewed or crushed, but should be swallowed whole.
","Respite produces a profound and long-lasting inhibition of gastric acid secretion. An interaction with a compound whose absorption is pH dependent may occur. Co-administration of rabeprazole sodium with ketoconazole or itraconazole may result in a significant decrease in antifungal plasma levels. Therefore individual patients may need to be monitored to determine if a dosage adjustment is necessary when ketoconazole or itraconazole are taken concomitantly with Respite. No interaction with liquid antacids was observed. The absorption of atazanavir is pH-dependent. Therefore PPIs, including rabeprazole, should not be co-administered with atazanavir.
","Hypersensitivity to the active substance or to any of the excipients. Rabeprazole is contra-indicated in pregnancy and during breastfeeding.
","In general, Rabeprazole is well-tolerated in both short-term and long-term studies. Rabeprazole may sometimes cause headache, diarrhoea, abdominal pain, vomiting, constipation, dry mouth, increased or decreased appetite, muscle pain, drowsiness, dizziness.
","US FDA pregnancy category 'C'. Studies have been performed in animals and have revealed no evidence of impaired fertility or harm to the fetus due to Rabeprazole. There are however, no adequate and well-controlled studies in pregnant women. Rabeprazole is likely to be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","
+- Symptomatic response to therapy with Rabeprazole does not preclude the presence of gastric or oesophageal malignancy, therefore the possibility of malignancy should be excluded prior to commencing treatment with Rabeprazole 20 mg Gastro-resistant Tablets.
+- Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance.
+- Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10–40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care and they should have an adequate intake of vitamin D and calcium.
+- A risk of cross-hypersensitivity reactions with other proton pump inhibitor or substituted benzimidazoles cannot be excluded.
+- Patients should be cautioned that Rabeprazole gastro-resistant tablets should not be chewed or crushed, but should be swallowed whole.
+- There have been post marketing reports of blood dyscrasias (thrombocytopenia and neutropenia). In the majority of cases where an alternative aetiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole.
+- Hepatic enzyme abnormalities have been seen in clinical trials and have also been reported since market authorisation. In the majority of cases where an alternative aetiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole.
+- No evidence of significant drug related safety problems was seen in a study of patients with mild to moderate hepatic impairment versus normal age and sex matched controls. However because there are no clinical data on the use of rabeprazole in the treatment of patients with severe hepatic dysfunction the prescriber is advised to exercise caution when treatment with Rabeprazole 20mg Gastro-resistant. Tablets is first initiated in such patients.
+- Co-administration of atazanavir with Rabeprazole is not recommended.
+- Treatment with proton pump inhibitors, including rabeprazole, may possibly increase the risk of gastrointestinal infections such as Salmonella, Campylobacter and Clostridium difficile.
+
+
Hypomagnesaemia: Severe hypomagnesaemia has been reported in patients treated with PPIs like rabeprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take PPIs with digoxin or drugs that may cause hypomagnesaemia (e.g., diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.
Influence on vitamin B12 absorption: Rabeprazole sodium, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or a- chlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed.
Subacute cutaneous lupus erythematosus (SCLE): Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Rabeprazole. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Interference with laboratory tests: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Rabeprazole 20mg Gastro-resistant Tablets treatment should be stopped for at least 5 days before CgA measurements. If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.
","Renal and hepatic impairment: No dosage adjustment is necessary for patients with renal or hepatic impairment.
Pediatric populations: Rabeprazole is not recommended for use in children due to a lack of data on safety and efficacy.
","The maximum established exposure has not exceeded 60 mg twice daily, or 160 mg once daily. Effects are generally minimal, representative of the known adverse event profile and reversible without further medical intervention. No specific antidote is known. Rabeprazole is extensively protein bound and is, therefore, not dialysable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilised.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",13
+77,Rabeprazole + Amoxicillin + Clarithromycin,rabeprazole-amoxicillin-clarithromycin-77,,Anti H. pylori drugs,Gastric ulcer,"Amoxicillin, Clarithromycin & Rabeprazol combination is indicated for the eradication of H. pylori in active chronic gastric, duodenal and gastric ulcers.
","Anti H. pylori drugs
","Amoxicillin is similar to penicillin in its bactericidal action against susceptible bacteria during the stage of active multiplication. It acts through the inhibition of cell wall biosynthesis that leads to the death of the bacteria.
Clarithromycin acts by inhibiting microsomal protein synthesis in susceptible organisms mainly by binding to the donor site on the 50S subunit of the bacterial ribosome and preventing translocation to that site.
Rabeprazole belongs to a class of antisecretory compounds (substituted benzimidazole proton-pump inhibitors) that do not exhibit anticholinergic or histamine H2-receptor antagonist properties, but suppress gastric acid secretion by inhibiting the gastric H+,K+ ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, rabeprazole has been characterized as a gastric proton-pump inhibitor. Rabeprazole blocks the final step of gastric acid secretion.
","Each strip twice daily for 7 days. In case of severity, each strip twice daily for 14 days.
",,"Rabeprazole is metabolized through the cytochrome P450 system, specially through the CYP3A and CYP2C19 isozymes. Studies have shown that Rabeprazole does not have clinically significant interactions with other drugs metabolized by the cytochrome P450 system, such as warfarin, antipyrine, indomethacin, ibuprofen, phenytoin, propranolol, prednisolone, diazepam, clarithromycin or terfenadine in healthy subjects. Use of Clarithromycin in patients who are receiving theophylline may be associated with an increase of serum theophylline concentrations. There have been reports of interactions of erythromycin and/or clarithromycin with carbamazepine, cyclosporine, tacrolimus, hexobarbital, phenytoin, alfetanil, disopyramide, lovastatin, bromocriptine, valproate, terfenadine, cisapride, pimozide & astemizole.
","This drug is contraindicated in patients with known hypersensitivity to any of its component.
","Adverse reactions which were reported as possibly or probably related to treatment (<3%) in clinical trials when all three components of this therapy were given concomitantly are listed below and divided by body systems.
Digestive system: Nausea, vomiting, diarrhoea, dark stools, dry mouth, glossitis, oral moniliasis, stomatitis, tongue discoloration; Musculoskeletal system: Myalgia;
Nervous System: Confusion, headache, dizziness; Skin: Skin reactions; Urogenital System: Vaginitis, vaginal moniliasis.
","There were no adequate and well-controlled studies of in pregnant women. Should be used during pregnancy only if the potential benefit justifies the potential risk of the mother. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug therapy, taking into account the importance of the therapy to the mother. Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate. Amoxicillin is excreted in human milk in very small amounts. There are no available human data on Rabeprazol use in pregnant women to inform the drug associated risk.
","Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on Amoxicillin therapy.
","Use in Geriatrics: Elderly patients may suffer from asymptomatic renal and hepatic dysfunction. Care should be taken when administering to this patient population.
Renal Dose Adjustments: No adjustment recommended.
Mild to moderate hepatic impairment: No adjustment recommended.
Severe hepatic impairment: Use with caution.
","There has been no experience of overdoses with Rabeprazole. In case of overdosage of Amoxicillin, medication is discontinued, treatment should be symptomatic and supportive measures are institued as required. Overdosage of Clarithromycin can cause gastrointestinal symptoms such as abdominal pain, vomiting, nausea and diarrhea.
",,,"Store in a cool and dry place, protected from light.
",12
+941,Quinine Sulfate,quinine-sulfate-941,https://medex.com.bd/attachments/XsxjL5Qlhp4CXEA1OQ4Roqwc9f62KM/quinine-sulfate-prescribing-information,Anti-malarial drugs,Nocturnal leg cramps,"Quinine Sulfate is indicated in-
+
+- Uncomplicated, severe and complicated falciparum malaria
+- Falciparum malaria resistant to other drugs
+- Prevention of nocturnal muscle cramps
+- Alleviation of muscle cramps in Thomsen's disease.
+
","Anti-malarial drugs
","Quinine is believed to interfere with protein metabolism and inhibits nucleic acid synthesis in malarial parasites. Quinine is a highly active blood schizonticide and suppresses the asexual cycle of development of malaria parasites in the erythrocytes. It is effective both as a suppressive drug and in the over clinical attack of malaria.
","Adult:
+
+- Oral: 600 mg (of quinine salt) every 8 hours for 7 days.
+- Parenteral: lf the patient is seriously ill quinine should be given by intravenous infusion. The adult dosage regimen for quinine by infusion is loading dose of 20 mg/kg (up to maximum 1.4 g) of quinine salt infused over 4 hours then after 8-12 hours maintenance dose of 10 mg/kg (up to maximum 700 mg) of quinine salt infused over 4 hours every 8-12 hours (until patient can swallow tablets to complete the 7 days course).
+
+
Children:
+
+- Oral: Quinine is well tolerated by children. The dosage regimen for quinine by mouth for children is 10 mg/kg (of quinine salt) every 8 hours for 7 days.
+- Parenteral: The dosage regimen for quinine by intravenous infusion for children is calculated on a mg/kg basis as for adult.
+
+
Pregnancy: The adult treatment doses of oral and intravenous quinine given above (including the loading dose) can safely be given to pregnant women.
",,,"Hypersensitivity reaction, optic neuritis, in case of black water fever etc.
","Cinchonism which includes tinnitus, headache, nausea and visual disturbances. Hematological disorders and skin reaction may occur.
","In pregnancy, the quinine is not necessarily contraindicated. It is considered to be safe when used in therapeutic dosage in pregnancy. It is excreted in breast milk in insignificant amount which does not discard the use in lactation.
","Severe heart disease, myasthenia gravis, diabetes mellitus, IV injection should be given slowly. Use of Mefloquine with Quinine sulphate may increase the chance of side effects.
",,,,,"Use of Mefloquine with Quinine sulphate may increase the chance of side effects.
",9
+940,Quetiapine Fumarate,quetiapine-fumarate-940,https://medex.com.bd/attachments/alO9AvrdpMG6MubyPTnMan4GXDVwKQ/quetiapine-fumarate-prescribing-information,Atypical neuroleptic drugs,Unipolar and bipolar depression,"Quetiapine is indicated for the treatment of Acute and chronic psychoses, including schizophrenia, Bipolar Disorder including: treatment of manic episodes satisfying DSM-IV criteria for mania associated with bipolar disorder, treatment of depressive episodes associated with bipolar disorder, maintenance ... Read more
Quetiapine is indicated for the treatment of Acute and chronic psychoses, including schizophrenia, Bipolar Disorder including: treatment of manic episodes satisfying DSM-IV criteria for mania associated with bipolar disorder, treatment of depressive episodes associated with bipolar disorder, maintenance treatment of bipolar I disorder, in combination with a mood stabilizer, for the prevention of recurrence of manic, depressive or mixed episodes.
","Atypical neuroleptic drugs
","The mechanism of action of Quetiapine, as with other drugs having efficacy in the treatment of schizophrenia and acute manic episodes associated with bipolar disorder, is unknown. However, it has been proposed that this drug's efficacy in schizophrenia is mediated through a combination of dopamine type 2 (D2 ) and serotonin type 2 (5HT2) antagonism. Antagonism at receptors other than dopamine and 5HT 2 with similar receptor affinities may explain some of the other effects of Quetiapine. Quetiapine's antagonism of histamine H1 receptors may explain the somnolence observed with this drug. Quetiapine's antagonism of adrenergic α1 receptors may explain the orthostatic hypotension observed with this drug.
","Acute and chronic psychoses, including schizophrenia: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). From Day 4 onwards, the dose should be titrated to the usual effective dose range of 300-450 mg/day. However, this may be adjusted, depending on the clinical response and tolerability of the individual patient, within the range 150 to 750 mg/day.
Manic episodes associated with bipolar disorder: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustments up to 800mg/day by Day 6 should be in increments of no greater than 200 mg/day. The dose may be adjusted depending on clinical response & tolerability of the individual patient, within the range of 200 to 800 mg/day. The usual effective dose is in the range of 400 to 800mg/day.
Depressive episodes associated with bipolar disorder: Quetiapine should be administered once daily at bedtime, with or without food. The usual dose is 300 mg/day. The daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). Quetiapine can be titrated to 400 mg on Day 5 and up to 600mg by Day 8. Antidepressant efficacy was demonstrated with Quetiapine at 300mg and 600 mg, however no additional benefit was seen in the 600mg group during short term treatment.
Maintenance treatment of bipolar I disorder in combination with mood stabilizers: Patients who have responded to Quetiapine in combination therapy with a mood stabiliser for acute treatment of bipolar disorder should continue on Quetiapine therapy at the same dose. Quetiapine dose can be re-adjusted depending on clinical response and tolerability of the individual patient. Efficacy was demonstrated with Quetiapine (administered twice daily totalling 400mg to 800mg a day) as combination therapy with a mood stabilizer.
",,"Caution should be exercised when Quetiapine is used concomitantly with medicines known to cause electrolyte imbalance or to increase QT interval. Co-administration of Quetiapine and thioridazine or carbamazepine caused increases in the clearance of Quetiapine. Co-administration of Quetiapine with another microsomal enzyme inducer, phenytoin, also caused increases in the clearance of Quetiapine.
","Quetiapine is contra-indicated in patients who are hypersensitive to it.
","The most commonly reported Adverse Drug Reactions (ADRs) with Quetiapine are somnolence, dizziness, dry mouth, withdrawal (discontinuation) symptoms, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, weight gain, decreased haemoglobin and extrapyramidal symptoms.
","The safety and efficacy of Quetiapine during human pregnancy have not been established. Therefore, Quetiapine should only be used during pregnancy if the benefits justify the potential risks and the administered dose and duration of treatment should be as low and as short as possible. The degree to which Quetiapine is excreted into human milk is unknown. Women who are breast-feeding should therefore be advised to avoid breast-feeding while taking Quetiapine.
","
+- Suicide/suicidal thoughts or clinical worsening: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant remission occurs.
+- Concomitant Illness: Quetiapine should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or other conditions predisposing to hypotension. Quetiapine may induce orthostatic hypotension especially during the initial dose-titration period.
+- Seizures: As with other antipsychotics, caution is recommended when treating patients with a history of seizures.
+- Tardive Dyskinesia and Extrapyramidal Symptoms (EPS): If signs and symptoms of tardive dyskinesia appear, dose reduction or discontinuation of Quetiapine should be considered.
+- Neuroleptic Malignant Syndrome: This syndrome has been associated with antipsychotic treatment. Quetiapine should be discontinued and appropriate medical treatment given.
+- QT Prolongation: As with other antipsychotics, caution should be exercised when Quetiapine is prescribed in patients with cardiovascular disease or family history of QT prolongation.
+- Neutropenia: Severe neutropenia (<0.5x109/L) has been uncommonly reported in Quetiapine clinical trials. Most cases of severe neutropenia have occurred within the first two months of starting therapy with Quetiapine.
+- Hyperglycemia & diabetes mellitus: Increases in blood glucose and hyperglycaemia, and occasional reports of diabetes, have been observed in clinical trials with Quetiapine.
+
","Elderly: As with other antipsychotics, Quetiapine should be used with caution in the elderly, especially during the initial dosing period. The rate of dose titration may need to be slower, and the daily therapeutic dose lower, than that used in younger patients, depending on the clinical response and tolerability of the individual patient. The mean plasma clearance of Quetiapine was reduced by 30% to 50% in elderly subjects when compared with younger patients.
Children and Adolescents: Quetiapine is not indicated for use in children and adolescents below 18 years of age.
","In clinical trials, survival has been reported in acute overdoses of up to 30 grams of Quetiapine. There is no specific antidote to Quetiapine. In cases of severe intoxication, the possibility of multiple drug involvement should be considered, and intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system. In cases of Quetiapine overdose, refractory hypotension should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents (adrenaline and dopamine should be avoided, since beta stimulation may worsen hypotension in the setting of Quetiapine-induced alpha blockade). Close medical supervision and monitoring should be continued until the patient recovers.
",,,"Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister pack and the carton. The expiry date refers to the last day of that month. Store in a cool and dry place away from light.
",12
+937,Pyrimethamine,pyrimethamine-937,https://medex.com.bd/attachments/vp3UcURlAv309Cb758G6Et50wefO5C/pyrimethamine-prescribing-information,Anti-malarial drugs,Toxoplasmosis,"Treatment of Toxoplasmosis: Pyrimethamine is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.
Treatment of Acute Malaria: Pyrimethamine is also indicated for the treatment ... Read more
Treatment of Toxoplasmosis: Pyrimethamine is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.
Treatment of Acute Malaria: Pyrimethamine is also indicated for the treatment of acute malaria. It should not be used alone to treat acute malaria. Fast-acting schizonticides such as chloroquine or quinine are indicated and preferable for the treatment of acute malaria. However, conjoint use of Pyrimethamine with a sulfonamide (e.g., sulfadoxine) will initiate transmission control and suppression of susceptible strains of plasmodia.
Chemoprophylaxis of Malaria: Pyrimethamine is indicated for the chemoprophylaxis of malaria due to susceptible strains of plasmodia. However, resistance to pyrimethamine is prevalent worldwide. It is not suitable as a prophylactic agent for travelers to most areas.
","Anti-malarial drugs
","Pyrimethamine is a folic acid antagonist structurally similar to trimethoprim. It inhibits parasitic dihydrofolate reductase, thus inhibiting vital tetrahydrofolic acid synthesis. It is active against pre-erythrocytic forms and is also a slow-acting schizontocide.
","For Treatment of Toxoplasmosis: The dosage of Pyrimethamine for the treatment of toxoplasmosis must be carefully adjusted so as to provide maximum therapeutic effect and a minimum of side effects. At the dosage required, there is a marked variation in the tolerance to the drug. Young patients may tolerate higher doses than older individuals. Concurrent administration of folinic acid is strongly recommended in all patients.
The adult starting dose is 50 to 75 mg of the drug daily, together with 1 to 4 g daily of a sulfonamide of the sulfapyrimidine type, e.g. sulfadoxine. This dosage is ordinarily continued for 1 to 3 weeks, depending on the response of the patient and tolerance to therapy. The dosage may then be reduced to about one half that previously given for each drug and continued for an additional 4 to 5 weeks.
The pediatric dosage of Pyrimethamine is 1 mg/kg/day divided into 2 equal daily doses; after 2 to 4 days this dose may be reduced to one half and continued for approximately 1 month. The usual pediatric sulfonamide dosage is used in conjunction with Pyrimethamine.
For Treatment of Acute Malaria: Pyrimethamine is NOT recommended alone in the treatment of acute malaria. Fast-acting schizonticides, such as chloroquine or quinine, are indicated for treatment of acute malaria. However, Pyrimethamine at a dosage of 25 mg daily for 2 days with a sulfonamide will initiate transmission control and suppression of non-falciparum malaria. Pyrimethamine is only recommended for patients infected in areas where susceptible plasmodia exist. Should circumstances arise wherein Pyrimethamine must be used alone in semi- immune persons, the adult dosage for acute malaria is 50 mg for 2 days; children 4 through 10 years old may be given 25 mg daily for 2 days. In any event, clinical cure should be followed by the once-weekly regimen described below for chemoprophylaxis. Regimens which include suppression should be extended through any characteristic periods of early recrudescence and late relapse, i.e., for at least 10 weeks in each case.
For Chemoprophylaxis of Malaria:
+
+- Adults and pediatric patients over 10 years: 25 mg (1 tablet) once weekly
+- Children 4 through 10 years: 12.5 mg (½ tablet) once weekly
+- Infants and children under 4 years: 6.25 mg (¼ tablet) once weekly.
+
",,"Pyrimethamine may be used with sulfonamides, quinine and other antimalarials, and with other antibiotics. However, the concomitant use of other antifolic drugs or agents associated with myelosuppression including sulfonamides or trimethoprim-sulfamethoxazole combinations, proguanil, zidovudine, or cytostatic agents (e.g., methotrexate), while the patient is receiving pyrimethamine, may increase the risk of bone marrow suppression. If signs of folate deficiency develop, pyrimethamine should be discontinued. Folinic acid (leucovorin) should be administered until normal hematopoiesis is restored
","Use of Pyrimethamine is contraindicated in patients with known hypersensitivity to pyrimethamine or to any component of the formulation. Use of the drug is also contraindicated in patients with documented megaloblastic anemia due to folate deficiency.
","Hypersensitivity reactions, occasionally severe (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and anaphylaxis), and hyperphenylalaninemia, can occur particularly when pyrimethamine is administered concomitantly with a sulfonamide. Consult the complete prescribing information for the relevant sulfonamide for sulfonamideassociated adverse events. With doses of pyrimethamine used for the treatment of toxoplasmosis, anorexia and vomiting may occur. Vomiting may be minimized by giving the medication with meals; it usually disappears promptly upon reduction of dosage. Doses used in toxoplasmosis may produce megaloblastic anemia, leukopenia, thrombocytopenia, pancytopenia, neutropenia, atrophic glossitis, hematuria, and disorders of cardiac rhythm.
","Pregnancy Category C. Pyrimethamine has been shown to be teratogenic in rats when given in oral doses 7 times the human dose for chemoprophylaxis of malaria or 2.5 times the human dose for treatment of toxoplasmosis. At these doses in rats, there was a significant increase in abnormalities such as cleft palate, brachygnathia, oligodactyly, and microphthalmia. Pyrimethamine has also been shown to produce terata such as meningocele in hamsters and cleft palate in miniature pigs when given in oral doses 170 and 5 times the human dose, respectively, for chemoprophylaxis of malaria or for treatment of toxoplasmosis.
There are no adequate and well-controlled studies in pregnant women. Pyrimethamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Concurrent administration of folinic acid is strongly recommended when used for the treatment of toxoplasmosis during pregnancy.
Nursing Mothers: Pyrimethamine is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from pyrimethamine and from concurrent use of a sulfonamide with Pyrimethamine for treatment of some patients with toxoplasmosis, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother
","The recommended dosage for chemoprophylaxis of malaria should not be exceeded. Pyrimethamine should be used with caution in patients with impaired renal or hepatic function or in patients with possible folate deficiency, such as individuals with malabsorption syndrome, alcoholism, or pregnancy, and those receiving therapy, such as phenytoin, affecting folate levels
","Geriatric Use: Clinical studies of Pyrimethamine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
",,,,,10
+1443,Pyridoxine Hydrochloride + Doxylamine Succinate,pyridoxine-hydrochloride-doxylamine-succinate-1443,https://medex.com.bd/attachments/obZyHsTeGuKHOBIPLsn4HY6Nk9WKCX/pyridoxine-hydrochloride-doxylamine-succinate-prescribing-information,Anti-emetic drugs,Pregnancy-associated nausea and vomiting,"This is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.
","Anti-emetic drugs
","Doxylamine Succinate is an antihistamine that blocks Histamine (H1) receptor. It can cross the blood brain barrier and has a high affinity for H1 receptors in the brain that blocks H1 receptors. It also decreases the action of histamine at the H1 receptor by inhibiting both vestibular system & Muscarinic receptor. It affects the vestibular system & decreases the stimulation of the vomiting center. Its muscarinic receptor inhibition may also play a role in antihistamine antiemetic activity. Pyridoxine Hydrochloride is a vitamin B6 analog. It is used to prevent nausea and vomiting due to its antiemetic properties.
","Initially, take one tablet orally at bedtime (Day 1). If this dose adequately controls symptoms the next day, continue taking one tablet daily at bedtime only. However, if symptoms persist on Day 2, increase the daily dose to one tablet in the morning and one tablet at bedtime. The maximum recommended dose is two tablets per day, one in the morning and one at bedtime. Take on an empty stomach with a glass of water. Swallow tablets whole. Do not crush, chew, or split this tablets. Take daily and not on an as needed basis.
",,"Use of Doxylamine Succinate & Pyridoxine Hydrochloride is contraindicated in women who are taking monoamine oxidase inhibitors (MAOIs), which prolong and intensify the adverse central nervous system effects (the anticholinergic effects) of antihistamines. Concurrent use of alcohol and other CNS depressants (such as hypnotic sedatives and tranquilizers) with Doxylamine Succinate & Pyridoxine Hydrochloride is not recommended.
","Doxylamine Succinate & Pyridoxine Hydrochloride is contraindicated in women with any of the following conditions:
+
+- Known hypersensitivity to Doxylamine Succinate, other ethanolamine derivative antihistamines, Pyridoxine Hydrochloride or any inactive ingredient in the formulation
+- Monoamine oxidase (MAO) inhibitors intensify and prolong the adverse central nervous system effects of Doxylamine Succinate & Pyridoxine Hydrochloride
+
","Somnolence or other accidents resulting from the effect of the combined use of Doxylamine Succinate & Pyridoxine Hydrochloride with CNS depressants.
","Pregnancy category A. This is intended for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Both Doxylamine Succinate & Pyridoxine Hydrochloride are excreted into breast milk. Therefore, caution should be exercised while breastfeeding.
","Doxylamine Succinate & Pyridoxine Hydrochloride may cause somnolence due to the anticholinergic properties of Doxylamine Succinate, an antihistamine. Women should avoid engaging in activities, such as driving or operating heavy machinery, while using Doxylamine Succinate & Pyridoxine Hydrochloride. Doxylamine Succinate & Pyridoxine Hydrochloride use is not recommended if a woman is concurrently using central nervous system (CNS) depressants including alcohol.
Doxylamine Succinate & Pyridoxine Hydrochloride has anticholinergic properties and, therefore, should be used with caution in women with asthma, increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction or urinary bladder-neck obstruction.
",,"Doxylamine Succinate & Pyridoxine Hydrochloride is an extended-release or Delayed Release formulation; therefore, signs and symptoms of intoxication may not be apparent immediately. Signs and symptoms of overdose may include restlessness, dryness of mouth, dilated pupils, sleepiness, vertigo, mental confusion and tachycardia. At toxic doses, Doxylamine Succinate exhibits anticholinergic effects, including seizures, rhabdomyolysis, acute renal failure and death. If treatment is needed, it consists of gastric lavage or activated charcoal, whole bowel irrigation and symptomatic treatment.
",,,"Store at below 30°C in a dry place protected from light. Keep out of reach of children.
",11
+936,Pyridoxine Hydrochloride,pyridoxine-hydrochloride-936,https://medex.com.bd/attachments/5hToxfDkXccExSjZ8rhJ5BDJ7xZt7l/pyridoxine-hydrochloride-injection-prescribing-information,Vitamin-B preparations,Vitamin B6 deficiency,"Pyridoxine (vitamin B6) is used to prevent or treat low levels of vitamin B6 in people who do not get enough of the vitamin from their diets. Most people who eat a normal diet do not need extra vitamin B6. However, some conditions (such as alcoholism, liver disease, overactive thyroid, heart ... Read more
Pyridoxine (vitamin B6) is used to prevent or treat low levels of vitamin B6 in people who do not get enough of the vitamin from their diets. Most people who eat a normal diet do not need extra vitamin B6. However, some conditions (such as alcoholism, liver disease, overactive thyroid, heart failure) or medications (such as isoniazid, cycloserine, hydralazine, penicillamine) can cause low levels of vitamin B6. Vitamin B6 plays an important role in the body. It is needed to maintain the health of nerves, skin, and red blood cells.
Pyridoxine has been used to prevent or treat a certain nerve disorder (peripheral neuropathy) caused by certain medications (such as isoniazid). It has also been used to treat certain hereditary disorders (such as xanthurenic aciduria, hyperoxaluria, homocystinuria).
","Vitamin-B preparations
","Pyridoxine is a water-soluble vitamin which functions in the metabolism of carbohydrates, proteins and fats. It is essential in Hb formation and GABA synthesis within the CNS. It also aids in the release of glycogen stored in the liver and muscles.
","ADULTS:
+BY MOUTH:
+
+- For hereditary sideroblastic anemia: Initially, 200-600 mg of vitamin B6 is used. The dose is decreased to 30-50 mg per day after an adequate response.
+- For vitamin B6 deficiency: In most adults, the typical dose is 2.5-25 mg daily for three weeks then 1.5-2.5 mg per day thereafter. In women taking birth control pills, the dose is 25-30 mg per day.
+- For abnormally high levels of homocysteine in the blood: For reducing high levels of homocysteine in the blood after childbirth, 50-200 mg of vitamin B6 has been taken alone. Also, 100 mg of vitamin B6 has been taken in combination with 0.5 mg of folic acid.
+- For preventing macular degeneration: 50 mg of vitamin B6 in the form of pyridoxine has been used daily in combination with 1000 mcg of vitamin B12 (cyanocobalamin) 1000 mcg and 2500 mcg of folic acid for about 7 years.
+- For hardening of the arteries (atherosclerosis): A specific supplement (Kyolic, Total Heart Health, Formula 108, Wakunga) containing 250 mg of aged garlic extract, 100 mcg of vitamin B12, 300 mcg of folic acid, 12.5 mg of vitamin B6, and 100 mg of L-arginine daily for 12 months.
+- For kidney stones: 25-500 mg of vitamin B6 has been used daily.
+- For nausea during pregnancy: 10-25 mg of vitamin B6 taken three or four times per day has been used. In people who don't respond to vitamin B6 alone, a combination product containing vitamin B6 and the drug doxylamine (Diclectin, Duchesnay Inc.) is used three or four times per day. Also, another product containing 75 mg of vitamin B6, 12 mcg of vitamin B12, 1 mg of folic acid, and 200 mg of calcium (PremesisRx, KV Pharmaceuticals) is used daily.
+- For symptoms of premenstrual syndrome (PMS): 50-100 mg of vitamin B6 is used daily, alone or along with 200 mg of magnesium.
+- For treating tardive dyskinesia: 100 mg of vitamin B6 per day has been increased weekly up to 400 mg per day, given in two divided doses.
+
+INJECTED INTO THE MUSCLE:
+
+- Hereditary sideroblastic anemia: 250 mg of vitamin B6 daily, reduced to 250 mg of vitamin B6 weekly once adequate response is achieved.
+
+
CHILDREN:
+BY MOUTH:
+
+- For kidney stones: Up to 20 mg/kg daily in children aged 5 years and up.
+
+INJECTED INTO THE VEIN OR MUSCLE:
+
+- For seizures that respond to vitamin B6 (pyridoxine-dependent seizures): 10-100 mg is recommended.
+
+The daily recommended dietary allowances (RDAs) of vitamin B6 are:
+
+- Infants 0-6 months, 0.1 mg
+- Infants 7-12 months, 0.3 mg
+- Children 1-3 years, 0.5 mg
+- Children 4-8 years, 0.6 mg
+- Children 9-13 years, 1 mg
+- Males 14-50 years, 1.3 mg
+- Males over 50 years, 1.7 mg
+- Females 14-18 years, 1.2 mg
+- Females 19-50 years, 1.3 mg
+- Females over 50 years, 1.5 mg
+- Pregnant women, 1.9 mg
+- Breast-feeding women, 2 mg
+- Some researchers think the RDA for women 19-50 years should be increased to 1.5-1.7 mg per day.
+
+The recommended maximum daily intake is:
+
+- Children 1-3 years, 30 mg
+- Children 4-8 years, 40 mg
+- Children 9-13 years, 60 mg
+
+Adults, pregnant and breast-feeding women:
+
+- 14-18 years, 80 mg
+- over 18 years, 100 mg
+
",,"The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.
To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.
Some products that may interact with this vitamin include: altretamine, cisplatin, phenytoin.
This vitamin may interfere with certain laboratory tests (including urine test for urobilinogen), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this vitamin.
",,"Pyridoxine usually has no side effects when used in recommended doses.
If your doctor has prescribed this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Pyridoxine can cause side effects when taken in large doses for a long time. Tell your doctor right away if any of these unlikely but serious side effects occur: headache, nausea, drowsiness, numbness/tingling of arms/legs.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
","Category A: Controlled studies in women fail to demonstrate a risk to the foetus in the 1st trimester (and there is no evidence of a risk in later trimesters), and the possibility of foetal harm remains remote.
","Before taking pyridoxine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
During pregnancy, this vitamin has been found to be safe when used in recommended doses.
This vitamin passes into breast milk and is considered to be safe during breast-feeding when used in recommended doses. Consult your doctor for more information.
",,,,,,8
+935,Pyridostigmine Bromide,pyridostigmine-bromide-935,https://medex.com.bd/attachments/OQPbYUTgk8JzKa0nPKDT5VZccI27Vf/pyridostigmine-bromide-prescribing-information,Drugs used in Myasthenia Gravis,Paralytic ileus,"Pyridostigmine Bromide is indicated in-
+
+- Myasthenia gravis
+- Paralytic ileus
+- Postoperative urinary retention
+
","Drugs used in Myasthenia Gravis
","Pyridostigmine tablet is an orally active cholinesterase inhibitor. Pyridostigmine inhibits the destruction of acetylcholine by cholinesterase and thereby permits freer transmission of nerve impulses across the neuromuscular junction. Pyridostigmine is an analog of neostigmine, but differs from it in certain clinically significant respects; for example, Pyridostigmine is characterized by a longer duration of action and fewer gastrointestinal side effects.
","Adults: Doses of 60 to 120 mg (1 or 2 tablets) by mouth are given at intervals throughout the day when maximum strength is needed (for example on rising and before mealtimes). The usual duration of action of a dose is three to four hours in the daytime but a longer effect (six hours) is often obtained with a dose taken on retiring for bed. The total daily dose is usually in the range of 5-20 tablets but some patients may require doses higher than these.
Newborn Infants: The dosage requirements of Pyridostigmine range from 5-10 mg orally every four hours, given 30-60 minutes before feeding. Treatment is not usually required beyond eight weeks of age except in the rare conditions of congenital and familial infantile myasthenia.
Older Children: Children under 6 years old should receive an initial dose of half a tablet (30 mg) of Pyridostigmine, children 6-12 years old should receive one tablet (60 mg). Dosage should be increased gradually, in increments of 15-30 mg daily, until maximum improvement is obtained. Total daily requirements are usually in the range of 30-360 mg by mouth.
",,"A potential interaction between the antimalarial drug mefloquine and pyridostigmine bromide exists through a possible additive effect on the gastrointestinal tract. Theoretically, drugs such as dexpanthenol, which are converted to pantothenic acid in vivo, may have additive effects with pyridostigmine by increasing production of acetylcholine.
","Pyridostigmine is contraindicated in mechanical intestinal or urinary obstruction, and particular caution should be used in its administration to patients with bronchial asthma. Care should be observed in the use of atropine for counteracting side effects.
","The side effects of Pyridostigmine are most commonly related to overdosage and generally are of two varieties, muscarinic and nicotinic. Among those in the former group are nausea, vomiting, diarrhea, abdominal cramps, increased peristalsis, increased salivation, increased bronchial secretions, miosis and diaphoresis. Nicotinic side effects are comprised chiefly of muscle cramps, fasciculation and weakness. Muscarinic side effects can usually be counteracted by atropine, but for reasons shown in the preceding section the expedient is not without danger. As with any compound containing the bromide radical, a skin rash may be seen in an occasional patient. Such reactions usually subside promptly upon discontinuance of the medication.
","The safety of Pyridostigmine during pregnancy or lactation has not been established.
","Pyridostigmine is mainly excreted unchanged by the kidney. Therefore, lower doses may be required in patients with renal disease, and treatment should be based on titration of drug dosage to effect.
",,,,,"Store in cool and dry place, protected from light. Keep out of children’s reach.
",10
+934,Pyrazinamide,pyrazinamide-934,https://medex.com.bd/attachments/9vzi446ZKUCbvj6IqRYeYvfSJnjQ7e/pyrazinamide-prescribing-information,Anti-Tubercular Chemotherapeutics,Tuberculosis,"Pyrazinamide is indicated for the initial treatment of active tuberculosis in adults and children when combined with other antituberculous agents.
+
+- The current recommendation of the CDC for drug-susceptible disease is to use a six-month regimen for initial treatment of active tuberculosis, consisting of isoniazid, rifampin and Pyrazinamide given for 2 months, followed by isoniazid and rifampin for 4 months
... Read more
Pyrazinamide is indicated for the initial treatment of active tuberculosis in adults and children when combined with other antituberculous agents.
+
+- The current recommendation of the CDC for drug-susceptible disease is to use a six-month regimen for initial treatment of active tuberculosis, consisting of isoniazid, rifampin and Pyrazinamide given for 2 months, followed by isoniazid and rifampin for 4 months
+- Patients with drug-resistant disease should be treated with regimens individualized to their situation. Pyrazinamide frequently will be an important component of such therapy.
+- In patients with concomitant HIV infection, the physician should be aware of current recommendation of CDC. It is possible these patients may require a longer course of treatment
+
+It is also indicated after treatment failure with other primary drugs in any form of active tuberculosis.
Pyrazinamide should only be used in conjunction with other effective antituberculous agents.
","Anti-Tubercular Chemotherapeutics
","Pyrazinamide may be bacteriostatic or bactericidal in action, depending on the concentration of the drug attained at the site of the infection and the susceptibility of the infecting organism. Its activity appears to partly depend on conversion of the drug to pyrazinoic acid (POA), which lowers the pH of the environment below that which is necessary for growth of Mycobacterium tuberculosis. Susceptible strains of M. tuberculosis produce pyrazinamidase, an enzyme that deaminates pyrazinamide to POA, and the in vitro susceptibility of a given strain of the organism appears to correspond to its pyrazinamidase activity.
","Usual Adult Dose for Tuberculosis: Active:
+15 to 30 mg/kg (up to 2 g) orally once a day in combination with three other antituberculous drugs for the initial 2 months of a 6-month or 9-month treatment regimen, until drug susceptibility tests are known. An alternate dosing regimen of 50 to 75 mg/kg (up to 3 g) orally twice a week may be used after 2 weeks of daily therapy to increase patient compliance.
Alternatively, the CDC, The American Thoracic Society, and the Infectious Diseases Society of America suggest the following dosing based on estimated lean body weight:
Daily dosing:
+
+- 40 to 45 kg: 1000 mg
+- 56 to 75 kg: 1500 mg
+- 76 to 90 kg: 2000 mg
+
+Twice weekly dosing:
+
+- 40 to 55 kg: 2000 mg
+- 56 to 75 kg: 3000 mg
+- 76 to 90 kg: 4000 mg
+
+Thrice weekly dosing:
+
+- 40 to 55 kg: 1500 mg
+- 56 to 75 kg: 2500 mg
+- 76 to 90 kg: 3000 mg
+
+
Usual Adult Dose for Tuberculosis: Latent:
+A public health expert should be consulted prior to the use of the combination regimen with rifampin.
15 to 20 mg/kg, based on actual body weight (lean), orally once daily (maximum 2 g) for 2 months. Alternatively, a dosage of 50 mg/kg may be administered orally twice-weekly (maximum 4 g).
+
Usual Pediatric Dose for Tuberculosis: Active:
+(Used as part of a multidrug regimen. Treatment regimens consist of an initial 2-month phase, followed by a continuation phase of 4 or 7 additional months. Frequency of dosing may differ depending on phase of therapy)
Infants, Children less than 40 kg and Adolescents 14 years and younger and less than 40 kg:
Non-HIV patients:
+
+- Daily therapy: 15 to 30 mg/kg/dose (maximum: 2 g/dose) once daily
+- Directly observed therapy (DOT): 50 mg/kg/dose (maximum: 2 g/dose) twice weekly
+
+HIV-exposed/infected patients:
+
+- Daily therapy: 20 to 40 mg/kg/dose once daily (maximum: 2 g/day)
+
",,"Antagonises the effect of uricosuric agents (e.g. probenecid, sulfinpyrazone). May reduce the contraceptive effect of oestrogens. May inactivate oral typhoid vaccine. May increase the serum concentration of ciclosporin. May enhance the hepatotoxic effect of rifampicin.
","Pyrazinamide is contraindicated in persons:
+
+- With severe hepatic damage.
+- Who have shown hypersensitivity to it.
+- With acute gout.
+
","General: Fever, porphyria and dysuria have rarely been reported. Gout.
Gastrointestinal: The principal adverse effect is a hepatic reaction. Hepatotoxicity appears to be dose related, and may appear at any time during therapy. GI disturbances including nausea, vomiting and anorexia have also been reported.
Hematologic and Lymphatic: Thrombocytopenia and sideroblastic anemia with erythroid hyperplasia, vacuolation of erythrocytes and increased serum iron concentration have occurred rarely with this drug. Adverse effects on blood clotting mechanisms have also been rarely reported.
Other: Mild arthralgia and myalgia have been reported frequently. Hypersensitivity reactions including rashes, urticaria, and pruritis have been reported. Fever, acne, photosensitivity, porphyria, dysuria and interstitial nephritis have been reported rarely.
","Pregnancy Category C. Animal reproduction studies have not been conducted with Pyrazinamide. It is also not known whether Pyrazinamide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pyrazinamide should be given to a pregnant woman only if clearly needed.
Nursing Mothers: Pyrazinamide has been found in small amounts in breast milk. Therefore, it is advised that Pyrazinamide be used with caution in nursing mothers taking into account the risk-benefit of this therapy.
","Pyrazinamide is contraindicated in patients with severe hepatic disease and with acute gout.
Patients started on pyrazinamide should have baseline serum uric acid and liver function test results. Liver function should be monitored closely during therapy. Patients with preexisting liver disease or those at increased risk of drug related hepatitis should be monitored closely.
Pyrazinamide should be discontinued and not restarted if signs of hepatocellular damage or hyperuricemia with an acute gouty arthritis appear.
Polyarthralgias have been reported in patients. The pain may respond to aspirin or other nonsteroidal anti-inflammatory agents.
Caution should be used in patients with a history of diabetes mellitus, as management of the disease may be more difficult.
Primary resistance of Mycobacterium tuberculosis to pyrazinamide is not common. In cases with known or suspected drug resistance, in vitro susceptibility tests with recent cultures of Mycobacterium tuberculosis against pyrazinamide and the usual primary drugs should be conducted. There are few reliable in vitro tests for pyrazinamide resistance. A reference laboratory capable of performing these tests must be utilized.
Clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for elderly patients should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased renal or hepatic function, and of concomitant disease or other drug therapy.
","Usage in Children: Pyrazinamide regimens employed in adults are probably equally effective in children. Pyrazinamide appears to be well tolerated in children.
Geriatric Use: Clinical studies of Pyrazinamide did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic or renal function, and of concomitant disease or other drug therapy.
It does not appear that patients with impaired renal function require a reduction in dose. It may be prudent to select doses at the low end of the dosing range, however.
Renal Dose Adjustments: The manufacturer recommends to start therapy at low end of dosage range and monitor patient closely.
For the treatment of active tuberculosis, the CDC, ATS, and IDSA recommend against daily dosing. For patients with CrCl less than 30 mL/min or patients receiving hemodialysis the recommended dose is 25 to 35 mg/kg per dose three times per week.
Liver Dose Adjustments: Monitor patients closely.
Dose Adjustments: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic or renal function, and of concomitant disease or other drug therapy.
If organism is susceptible to isoniazid and rifampin, pyrazinamide is continued for the first 2 months of a 6-month course of therapy (9-months if HIV positive). If primary drug resistance is shown, drug regimens should be adjusted as needed and continued for at least 6 months, or 3 months beyond culture conversion (9 months, or 6 months beyond culture conversion if HIV positive). If multiple-drug resistance is demonstrated, therapy should be continued for 12 to 24 months following culture conversion.
","Overdosage experience is limited. In one case report of overdose, abnormal liver function tests developed. These spontaneously reverted to normal when the drug was stopped. Clinical monitoring and supportive therapy should be employed. Pyrazinamide is dialyzable.
",,,"Store between 15-30° C.
",12
+933,Pyrantel Pamoate,pyrantel-pamoate-933,https://medex.com.bd/attachments/CnX5WbQH4kcITCRLIeZROmuKjNXKjm/pyrantel-pamoate-prescribing-information,Anthelmintic,Worm infections,"This medication is used to treat intestinal worm infections such as pinworm, roundworm, and hookworm. Pyrantel belongs to a class of drugs known as anthelmintics. It works by making the worms unable to move (paralyzed) so that the body can remove them naturally in the stool.
... Read more
This medication is used to treat intestinal worm infections such as pinworm, roundworm, and hookworm. Pyrantel belongs to a class of drugs known as anthelmintics. It works by making the worms unable to move (paralyzed) so that the body can remove them naturally in the stool.
Pyrantel Pamoate is specifically indicated for the treatment of infestations caused by Ascaris lumbricoides, Enterobius vermicularis, Ancylostoma duodenale/Necator americanus and Trichostrongylus.
This medication may be used to self-treat pinworm infections. For other types of worm infections (such as roundworm, hookworm), use this product only as directed by your doctor. Do not use this medication in children younger than 2 years unless directed by the doctor.
","Anthelmintic
","Pyrantel pamoate acts as a depolarizing neuromuscular blocking agent, thereby causing sudden contraction, followed by paralysis, of the helminths. This has the result of causing the worm to ""lose its grip"" on the intestinal wall and be passed out of the system by natural process. Since Pyrantel is poorly absorbed by the host's intestine, the host is unaffected by the small dosage of medication used. Spastic (tetanic) paralyzing agents, in particular pyrantel pamoate, may induce complete intestinal obstruction in a heavy worm load. This obstruction is usually in the form of a worm impaction and happens when a very small, but heavily parasitized animal is treated and tries to pass a large number of dislodged worms at once. Worms usually pass in normal stool or with diarrhea, straining, and occasional vomiting.
","Pyrantel Pamoate is given orally at anytime without regard to ingestion of food or beverages. A single dose of 11 mg/kg body weight, to a maximum of 1 gm, should be given to treat infestations caused by the parasites mentioned above. In the case of Pinworm, it is often wise to repeat the dose after an interval of 2 weeks.
",,,"Known hypersensitivity to pyrantel or any ingredient in the formulation.
","Pyrantel Pamoate is well tolerated in recommended dosage. When given in large dosage, Pyrantel Pamoate may cause gastrointestinal upset such as anorexia, nausea, vomiting and diarrhoea. Other side effects that may occur in rare occasions are headache, dizziness and rash.
","Pregnancy: Since Pyrantel Pamoate has not been studied in pregnant women, use of Pyrantel Pamoate in such patients is normally contraindicated. Pyrantel Pamoate is not recommended for children below 1 year of age.
","Since Pyrantel Pamoate and Piperazine appear to be mutually antagonistic, Pyrantel Pamoate should not be given together with Piperazine. Pyrantel Pamoate should be kept out of the reach of children.
","Pediatric Use: Safety and efficacy not established in children <2 years of age;a use in this age group only when potential benefits justify possible risks.
Hepatic Impairment: Use with caution in patients with preexisting liver dysfunction.
",,,,,9
+1219,Pseudoephedrine Hydrochloride,pseudoephedrine-hydrochloride-1219,https://medex.com.bd/attachments/HglDx8F9fZpUvVauj1Y9mwYFjfSnDh/pseudoephedrine-hydrochloride-prescribing-information,Decongestant,Nasal congestion,"Pseudoephedrine is a decongestant of the mucous membranes of the upper respiratory tract, especially the nasal mucosa, sinuses and eustachian tube. It is indicated for the symptomatic relief of allergic rhinitis (hay fever), vasomotor rhinitis, the common cold, influenza (flu) and ear congestion caused by ear inflammation or infection. Pseudoephedrine can also be used as a bronchodilator.
","Decongestant
","Pseudoephedrine is both an α-and β-adrenergic receptor agonist. It causes vasoconstriction via direct stimulation of α-adrenergic receptors of the respiratory mucosa. It also directly stimulates β-adrenergic receptors causing bronchial relaxation, increased heart rate and contractility.
Like ephedrine, pseudoephedrine releasing norepinephrine from its storage sites, an indirect effect. This is its main and direct mechanism of action. The displaced noradrenaline is released into the neuronal synapse where it is free to activate the postsynaptic adrenergic receptors.
","As a decongestant and symptomatic treatment for upper respiratory tract infections the recommended dose is:
Adults: 1 tablet every 4 to 6 hours, up to maximum of 240 mg in 24 hours
Children:
+
+- 6-12 years of age: 1/2 tablet every 4 to 6 hours daily
+- 2-5 years of age: 1/4 tablet every 4 to 6 hours daily
+- Less than 2 years of age: This drug is not advised unless specifically recommended by a physician.
+
",,,"Pseudoephedrine is contraindicated in-
+
+- Hypersensitivity of individuals to this drug
+- Severe hypertension and coronary artery disease
+- Concurrent use of Mono Amine Oxidase Inhibitor (MAOI) drugs
+
","Serious adverse effects associated with the use of Pseudoephedrine are rare. Symptoms of central nervous system excitation may occur, including sleep disturbances and, rarely, hallucinations have been reported. Skin rashes, with or without irritation, have occasionally been reported.
","Although Pseudoephedrine has been in widespread use for many years without apparent ill consequence, there are no specific data on its use during pregnancy. Caution should therefore be exercised by balancing the potential benefit of treatment to the mother against any possible hazards to the developing foetus. Pseudoephedrine is excreted in breast milk in small amounts but the effect of this on breast-fed infants is not known.
","Although Pseudoephedrine has virtually no pressor effects in normotensive patients, it should be used with caution in patients suffering mild to moderate hypertension. As with other sympathomimetic agents, Pseudoephedrine should be used with caution in patients with hypertension, heart disease, diabetes, hyperthyroidism, elevated intraocular pressure and prostatic enlargement. Caution should be exercised when using the product in the presence of severe hepatic impairment or moderate to severe renal impairment.
",,"As with other sympathomimetic agents, symptoms of overdosage include irritability, restlessness, tremor, convulsions, palpitations, hypertension and difficulty in micturition. Necessary measures should be taken to maintain and support respiration and control convulsions. Gastric lavage should be performed if indicated. If desired, the elimination of Pseudoephedrine can be accelerated by acid diuresis or by dialysis.
",,,,9
+536,Pseudoephedrine + Guaiphenasine + Triprolidine,pseudoephedrine-guaiphenasine-triprolidine-536,,Combined cough expectorants,Sneezing,"This is indicated for the symptomatic relief of upper respiratory tract disorders accompanied by productive cough which benefits from the administration of a nasal decongestant, a histamine H1 receptor antagonist and an expectorant combination.
","Combined cough expectorants
","Pseudoephedrine is a decongestant as well as a bronchodilator for the upper respiratory tract, which gives symptomatic relief of nasal congestion. Pseudoephedrine is both an α-and β-adrenergic receptor agonist. It causes vasoconstriction via direct stimulation of α-adrenergic receptors of the respiratory mucosa. It also directly stimulates β-adrenergic receptors causing bronchial relaxation, increased heart rate and contractility.
Like ephedrine, pseudoephedrine releasing norepinephrine from its storage sites, an indirect effect. This is its main and direct mechanism of action. The displaced noradrenaline is released into the neuronal synapse where it is free to activate the postsynaptic adrenergic receptors.
Guaifenesin reduces the viscosity of tenacious sputum and is used as an expectorant. It increases the hydration of respiratory tract, thereby increasing the volume and reducing the viscosity of bronchial secretions.
Triprolidine is an antihistamine; it is used for the symptomatic relief of hypersensitivity reactions including rhinitis, conjunctivitis and urticaria.
","Adult and Children over 12 years: 10 ml (2 teaspoonful) three times a day.
Children 6-12 years: 5 ml (1 teaspoonful) three times a day.
Children 2-5 years: 2.5 ml (1/2 teaspoonful) three times a day.
A physician’s advice is preferred before administering this preparation to children aged less than 2 years.
",,"Concomitant use of Pseudoephedrine, guaiphenasine & triprolidine with sympathomimetic agents such as decongestants, tricyclic antidepressants, appetite suppressants and amphetamine-like psychostimulants or with monoamine oxidase inhibitors which interfere with the catabolism of sympathomimetic amines may occasionally cause a rise in blood pressure. Because of its pseudoephedrine content, Pseudoephedrine, guaiphenasine & triprolidine partially reverse the hypotensive action of drugs which interfere with sympathetic activity including guanethidine, methyldopa, alpha-adrenergic blocking agents.
","This is contraindicated in the cases of known hypersensitivity to any of its constituents, cardiovascular disease including hypertension, lower respiratory symptoms including asthma, monoamine oxidase inhibitor (MAOI) therapy.
","CNS depression or excitation, drowsiness (reported most frequently), sleep disturbances, hallucinations (rarely reported), skin rashes with or without irritation, tachycardia, dryness of mouth, nose and throat have occasionally been reported.
","Although pseudoephedrine, triprolidine and guaiphenesin have been in widespread use of many years without apparent ill consequence, there are no specific data on their use during pregnancy. Caution should therefore be exercised by balancing the potential benefits of treatment of the mother against any possible hazards to the developing fetus.
","As with any other antihistamine therapy, Pseudoephedrine, guaiphenasine & triprolidine may cause drowsiness. If affected, patients should be advised not to drive or operate machinery. Concomitant administration of alcohol or other centrally acting sedatives should be avoided. Although Pseudoephedrine has no pressor effects in normotensive patients but Pseudoephedrine, guaiphenasine & triprolidine should be used with caution to patients suffering from mild to moderate hypertension. Moreover, caution should also be exercised in the following disease conditions - hypertension and heart disease, diabetes, hyperthyroidism, elevated intra-ocular pressure, prostatic enlargement, severe renal and hepatic impairment. This preparation should not be used for persistent or chronic cough, which occurs with smoking, asthma or emphysema or where excessive secretions accompany cough, unless directed by a physician.
",,"The effects of acute toxicity from Pseudoephedrine, guaiphenasine & triprolidine may include drowsiness, irritability, restlessness, lethargy, dizziness, gastrointestinal discomfort, respiratory depression, convulsion, tremor, tachycardia and hypertension. Incase of overdose, necessary measures should be taken to maintain and support respiration and control convulsion. Gastric lavage may be undertaken if indicated. Catheterization of bladder may be necessary.
",,,"Store below 25° C. Protect from light. Do not refrigerate.
",11
+1586,Prucalopride Succinate,prucalopride-succinate-1586,https://medex.com.bd/attachments/Xn2TjmtbJGbsVDDa1Z0ntlvWa2IKoQ/prucalopride-succinate-prescribing-information,Osmotic purgatives,Constipation,"Prucalopride is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.
","Osmotic purgatives
","Prucalopride acts as a selective stimulator of the 5-HT4 receptors while having no interaction with hERG channel or 5-HT1 receptors which reduces significantly the cardiovascular risk found in other similar drugs. 5-HT4 receptors can be found throughout the gastrointestinal tract primarily in smooth muscle cells, enterochromaffin cells, and myenteric plexus. Its activation produces the release of acetylcholine which is the major excitatory neurotransmitter in the GI tract. Hence, prucalopride stimulates motility by interacting specifically with 5-HT4 receptors in the GI tract which causes a release of acetylcholine and further contraction of the muscle layer of the colon and relaxation of the circular muscle layer leading to the propulsion of luminal content.
","Adults: 2 mg once daily with or without food, at any time of the day. Due to the specific mode of action of prucalopride (stimulation of propulsive motility), exceeding the daily dose of 2 mg is not expected to increase efficacy.
Older people: Start with 1 mg once daily; if needed the dose can be increased to 2 mg once daily.
Children: Prucalopride should not be used in children and adolescents younger than 18 years
",,"In-vitro data indicate that, Prucalopride has a low interaction potential and therapeutic concentrations of Prucalopride are not expected to affect the CYP-mediated metabolism of co medicated medicinal products. Although Prucalopride may be a weak substrate for P-glycoprotein (P-gp), it is not an inhibitor of P-gp at clinically relevant concentrations.
Ketoconazole (200 mg b.i.d.), a potent inhibitor of CYP3A4 and of P-gp, increased the systemic exposure to prucalopride by approximately 40%. This effect is too small to be clinically relevant. Interactions of similar magnitude may be expected with other potent inhibitors of P-gp such as verapamil, cyclosporine A and quinidine.
Studies in healthy subjects showed that, there were no clinically relevant effects of Prucalopride on the pharmacokinetics of warfarin, digoxin, alcohol, paroxetine or oral contraceptives.
","Prucalopride is contraindicated in those people who are hypersensitive to the active substance or to any of the excipients and people with renal impairment requiring dialysis.
","The most frequently reported adverse reactions associated with Prucalopride therapy are headache (17.8%) and gastrointestinal symptoms (abdominal pain), nausea and diarrhoea. The adverse reactions occur predominantly at the start of therapy and usually disappear within a few days with continued treatment. Other adverse reactions have been reported occasionally. The majority of adverse events were mild to moderate in intensity.
","Prucalopride is not recommended during pregnancy and women of childbearing potential should use effective contraception during treatment. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition, or postnatal development. In the absence of human data, it is not recommended to use Prucalopride during breastfeeding
","
+- Renal excretion is the main route of elimination of prucalopride. A dose of 1 mg is recommended in subjects with severe renal impairment.
+- Caution should be exercised when prescribing Prucalopride to patients with severe hepatic impairment (Child-Pugh class C) due to limited data in patients with severe hepatic impairment.
+- In case of severe diarrhoea, the efficacy of oral contraceptives may be reduced and the use of an additional contraceptive method is recommended to prevent possible failure of oral contraception.
+- The tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
+
","Renal Impairment: The dose for patients with severe renal impairment (GFR <30 ml/min/1.73 m2) is 1 mg once daily. No dose adjustment is required for patients with mild to moderate renal impairment.
Hepatic Impairment: Patients with severe hepatic impairment (Child-Pugh class C) start with 1 mg once daily which may be increased to 2 mg if required to improve efficacy and if the 1 mg dose is well tolerated. No dose adjustment is required for patients with mild to moderate hepatic impairment.
","An overdose may result in symptoms resulting from an exaggeration of prucalopride's known pharmacodynamic effects and include headache, nausea and diarrhoea. Specific treatment is not available for Prucalopride overdose. Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted, as required. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.
",,,"Store at room temperature, below 30°C. Do not remove desiccant. Dispense in original bottle.
",12
+1255,"Protein, Fat, Carbohydrate, Vitamin & Mineral",protein-fat-carbohydrate-vitamin-mineral-1255,,Oral nutritional preparations,Vitamin or mineral deficiency,"Total diet replacement or supplement in anorexia, illness, convalescence, pregnancy, lactation, old age, weight loss, fatigue, pre- & post-surgical conditions, oral pathology, cancer, transition from TPN & tube feeding for adults & older persons. Specialized nutrition with fiber for diabetic patients.
","Oral nutritional preparations
","No data has found
","To prepare a 250 ml feeding, put 200 ml of cold water in a glass. Gradually add 6 level scoops (enclosed) of powder while stirring and mix until dissolved. When mixed as directed powder provides approx. 1 k.cal. per ml.
",,"There are no known drug interactions and none well documented
","Hypersensitivity to any of the ingredient of this product.
",,"Pregnancy Category: Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
",,,,,,,7
+1269,Protamine Sulfate,protamine-sulfate-1269,https://medex.com.bd/attachments/spcwbopiGp4vF4C1mR33t54NZcviph/protamine-sulfate-prescribing-information,Antidote preparations,Heparin overdosage,"Protamine Sulfate Injection is indicated in the treatment of heparin overdosage
","Antidote preparations
","Protamine sulfate is prepared from the sperm or mature testes of salmon or related species and is composed of arginine, proline, serine and valine. It combines with strongly acidic heparin to form a stable complex, neutralising the anticoagulant activity of both drugs.
","Each mg of Protamine Sulfate will neutralize approximately 90 units of heparin activity derived from beef lung tissue or about 115 units of heparin activity derived from porcine intestinal mucosa.
Protamine Sulfate Injection, should be given by very slow intravenous injection in doses not to exceed 50 mg of Protamine Sulfate in any 10 minute period.
Protamine Sulfate is intended for injection without further dilution; however,if further dilution is desired, 5% Dextrose Injection,or 0.9% Sodium Chloride Injection may be used. Diluted solutions should not be stored since they contain no preservative.
Protamine Sulfate should not be mixed with other drugs without knowledge of their compatibility, because Protamine Sulfate has been shown to be incompatible with certain antibiotics,including several of the cephalosporins and penicillins.
Because heparin disappears rapidly from the circulation, the dose of Protamine Sulfate required also decreases rapidly with the time elapsed following intravenous injection of heparin.For example, if the Protamine Sulfate is administered 30 minutes after the heparin, one-half the usual dose may be sufficient.
The dosage of Protamine Sulfate should be guided by blood coagulation studies.Parenteral drug products should be visually inspected for particulate matter and discolouration prior to administration, whenever solution and container permit.
",,"Protamine sulfate has been shown to be incompatible with certain antibiotics, including several of the cephalosporins and penicillins
","Protamine sulfate is contraindicated in patients who have shown previous intolerance to the drug.
","Intravenous injections of Protamine sulfate may cause a sudden fall in blood pressure, bradycardia, pulmonary hypertension, dyspnea, or transitory flushing and a feeling of warmth. There have been reports of anaphylaxis that resulted in respiratory embarrassment. Other reported adverse reactions include systemic hypertension, nausea, vomiting and lassitude. Back pain has been reported rarely in conscious patients undergoing such procedures as cardiaccatheterization. Because fatal reactions often resembling anaphylaxis have been reported after administration of Protamine sulfate, the drug should be given only when resuscitation techniques and treatment of anaphylactoid shock are readily available.
","Usage in Pregnancy: Animal reproduction studies have not been conducted with Protamine sulfate . It is also not known whether Protamine sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Protamine sulfate should be given to a pregnant woman only if clearly needed.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Protamine sulfate is administered to a nursing woman.
","Patient at risk of developing hypersensitivity to protamine (e.g. previous history of procedures such as coronary angioplasty or cardiopulmonary bypass surgery where protamine is frequently used, diabetics using protamine insulin, allergy to fish, vasectomised or infertile males who may have antibodies to protamine). Pregnancy and lactation.
","Usage in Children: Safety and effectiveness in children have not been established.
","Because of the anticoagulant effect of Protamine sulfate , overdosage of this drug may theoretically result in hemorrhage. However, in one study, overdosage of 600 to 800 mg of intravenous Protamine sulfate had only minimal, transient effects on blood coagulation tests.The patient should be followed with coagulation studies and treated symptomatically. The LD50 of Protamine sulfate is 100 mg/kg in mice.
",,,"Store between 20-25° C. Do not freeze.
",12
+1504,Protamine Crystallised Insulin Aspart,protamine-crystallised-insulin-aspart-1504,,Rapid Acting Insulin,Type 1 DM,"Protamine Crystallised Insulin Aspart is an insulin analog indicated to improve glycemic control in patients with diabetes mellitus.
","Rapid Acting Insulin
","The primary activity of Insulin Aspart is the regulation of glucose metabolism. Insulin Aspart bind to the insulin receptors on muscle and fat cells and lower blood glucose by facilitating the cellular uptake of glucose and simultaneously inhibiting the output of glucose from the liver.
","Insulin Aspart has a faster onset and a shorter duration of action than soluble human insulin. Due to the faster onset of action, Insulin Aspart should generally be given immediately before a meal. When necessary Insulin Aspart may be given soon after a meal.
Dosage of Insulin Aspart is individual and determined on the basis of the physician's advice in accordance with the needs of the patient. It should normally be used in combination with long-acting insulin given at least once a day.
The individual insulin requirement is usually between 0.5 and 1.0 IU/kg/day in adults and children over 2 years of age. In a meal-related treatment 50-70% of this requirement may be provided by Insulin Aspart and the remainder by long-acting insulin. Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet. Exercise taken immediately after a meal may increase the risk of hypoglycaemia.
Subcutaneous Injection: Insulin Aspart should be administered by subcutaneous injection in the abdominal region, buttocks, thigh, or upper arm. Because Insulin Aspart has a more rapid onset and a shorter duration of activity than human regular insulin, it should be injected immediately (within 5-10 minutes) before a meal Continuous Subcutaneous Insulin Infusion (CSII) by External Pump Insulin Aspart can also be infused subcutaneously by an external insulin pump. The initial programming of the external insulin infusion pump should be based on the total daily insulin dose of the previous regimen. Approximately 50% of the total dose is usually given as meal-related boluses of Insulin Aspart and the remainder is given as a basal infusion. When used with an infusion pump Insulin Aspart should not be mixed with any other insulin.
Intravenous Use: Insulin Aspart can be administered intravenously under medical supervision for glycemic control with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia. For intravenous use, Insulin Aspart should be used at concentrations from 0.05 IU/mL to 1.0 IU/mL insulin aspart in infusion systems using polypropylene infusion bags. Insulin Aspart has been shown to be stable in infusion fluids such as 0.9% sodium chloride.
","Instructions to be given to the patient before injecting this Insulin:
+
+- According to the instruction given with ConviPen, insert the cartridge into the pen correctly & equip the needle
+- Gently turn the pen upside down for 8-10 times until the insulin in the cartridge becomes uniformly mixed suspension
+- Remove the needle cap, discharge air bubbles in the catridge
+- Adjust the dosage button to get correct dose & inject to the specific site
+- In order to avoid cross contamination, do not let the needle touch anything during the process of preparation.
+
","A number of drugs affect glucose metabolism and may require dose adjustment.
The following substances may reduce the Insulin as well as Insulin Aspart requirements: Oral anti-diabetic products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, propoxyphene, pentoxifylline, salicylates and sulfonamide antibiotics.
The following substances may increase the Insulin as well as Insulin Aspart requirements: Thiazides, glucocorticoids, thyroid hormones, beta-sympathomimetics, growth hormone and danazol. Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood glucose lowering effect of insulin.
",,"Side effects of Insulin Aspart are hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus and rash.
","Pregnancy category B. There are no restrictions on treatment with Protamine Crystallised Insulin Aspart during lactation. Insulin treatment of the nursing mother should not affect the baby. However, dosage may need to be adjusted.
","Dose adjustment and monitoring: Blood glucose should be monitored in all patients treated with insulin. Insulin regimens should be modified cautiously and only under medical supervision
",,"A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high doses relative to the patient’s requirement are administered. Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products. Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously. Glucose must also be given intravenously if the patient does not respond to glucagon within 10 to 15 minutes. Upon regaining consciousness administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
",,,"Store at 2°C to 8°C in a refrigerator. Do not freeze. Protect from light.
",11
+1826,Propylthiouracil,propylthiouracil-1826,https://medex.com.bd/attachments/lWFM1sVmAAbDlyKpAI4x84D87rPOXh/propylthiouracil-prescribing-information,Thyroid drugs & hormone,Hyperthyroidism,"Propylthiouracil is indicated:
+
+- in patients with Graves' disease with hyperthyroidism or toxic multinodular goiter who are intolerant of methimazole and for whom surgery or radioactive iodine therapy is not an appropriate treatment option
+- to ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy in patients who are intolerant of methimazole
+
","Thyroid drugs & hormone
","Propylthiouracil inhibits the synthesis of thyroid hormones and thus is effective in the treatment of hyperthyroidism. The drug does not inactivate existing thyroxine and triiodothyronine that are stored in the thyroid or circulating in the blood, nor does it interfere with the effectiveness of thyroid hormones given by mouth or by injection. Propylthiouracil inhibits the conversion of thyroxine to triiodothyronine in peripheral tissues and may therefore be an effective treatment for thyroid storm. Propylthiouracil is readily absorbed and is extensively metabolized. Approximately 35% of the drug is excreted in the urine, in intact and conjugated forms, within 24 hours.
","Adults: The initial dose is 300 mg daily. In patients with severe hyperthyroidism, very large goiters, or both, the initial dose may be increased to 400 mg daily; an occasional patient will require 600 to 900 mg daily initially. The usual maintenance dose is 100 to 150 mg daily.
Pediatric Patients: Propylthiouracil is generally not recommended for use in the pediatric patient population except in rare instances in which other alternative therapies are not appropriate options. Studies evaluating appropriate dosing regimen have not been conducted in the pediatric population although general practice would suggest initiation of therapy in patients 6 years or older at a dosage of 50 mg daily with careful upward titration based on clinical response and evaluation of TSH and free T4 levels. Although cases of severe liver injury have been reported with doses as low as 50 mg/day, most cases were associated with doses of 300 mg/day and higher.
",,"Anticoagulants (oral): Due to the potential inhibition of vitamin K activity by propylthiouracil, the activity of oral anticoagulants (e.g., warfarin) may be increased; additional monitoring of PT/INR should be considered, especially before surgical procedures.
Beta-adrenergic blocking agents: Hyperthyroidism may cause an increased clearance of beta blockers with a high extraction ratio. A reduced dose of beta-adrenergic blockers may be needed when a hyperthyroid patient becomes euthyroid.
Digitalis glycosides: Serum digitalis levels may be increased when hyperthyroid patients on a stable digitalis glycoside regimen become euthyroid; a reduced dose of digitalis glycosides may be needed.
Theophylline: Theophylline clearance may decrease when hyperthyroid patients on a stable theophylline regimen become euthyroid; a reduced dose of theophylline may be needed.
","Propylthiouracil is contraindicated in patients who have demonstrated hypersensitivity to the drug or any of the other product components.
","The most common side effects of Propylthiouracil include:
+
+- nausea
+- muscle pain
+- vomiting
+- headache
+- upper stomach pain or tenderness
+- sleepiness
+- joint pain
+- nerve pain
+- itching or tingling
+- swelling (edema)
+- loss or change in taste
+- dizziness
+- loss of hair
+- enlarged salivary glands or enlarged lymph node
+
","Pregnancy Category D. There are cases of liver injury, including liver failure and death, in women treated with propylthiouracil during pregnancy. Two reports of in utero exposure with liver failure and death of a newborn have been reported. If propylthiouracil is used during pregnancy, or if the patient becomes pregnant while taking propylthiouracil, the patient should be warned of the rare potential hazard to the mother and fetus of liver damage. Propylthiouracil crosses the placenta and can cause fetal goiter and cretinism when administered to a pregnant woman. After the first trimester of pregnancy, the use of an alternative antithyroid medication may be advisable.
Nursing Mothers: Propylthiouracil is present in breast milk to a small extent and therefore likely results in clinically insignificant doses to the nursing infant. In one study, nine lactating women were administered 400 mg of propylthiouracil by mouth. The mean amount of propylthiouracil excreted during 4 hours after drug administration was 0.025% of the administered dose.
","Patients should be instructed to report any symptoms of hepatic dysfunction (anorexia, pruritus, jaundice, light colored stools, dark urine, right upper quadrant pain, etc.), particularly in the first six months of therapy. When these symptoms occur, measurement should be made of liver function (bilirubin, alkaline phosphatase) and hepatocellular integrity (ALT/AST levels). Patients who receive propylthiouracil should be under close surveillance and should be counseled regarding the necessity of immediately reporting any evidence of illness, particularly sore throat, skin eruptions, fever, headache, or general malaise. In such cases, white blood cell and differential counts should be obtained to determine whether agranulocytosis has developed. Particular care should be exercised with patients who are receiving concomitant drugs known to be associated with agranulocytosis.
","Pediatric Use: Postmarketing reports of severe liver injury including hepatic failure requiring liver transplantation or resulting in death have been reported in the pediatric population. No such reports have been observed with methimazole. As such, propylthiouracil is not recommended for use in the pediatric population except in rare instances in which methimazole is not well-tolerated and surgery or radioactive iodine therapy are not appropriate. When used in children, parents and patients should be informed of the risk of liver failure. If patients taking propylthiouracil develop tiredness, nausea, anorexia, fever, pharyngitis, or malaise, propylthiouracil should be discontinued immediately by the patient, a physician should be contacted, and a white blood cell count, liver function tests, and transaminase levels obtained.
Geriatric Patients: Clinical studies of propylthiouracil did not include sufficient numbers of subjects aged 65 or over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
","Symptoms: Nausea, vomiting, epigastric distress, headache, fever, arthralgia, pruritus, edema, and pancytopenia. Agranulocytosis is the most serious effect. Rarely, exfoliative dermatitis, hepatitis, neuropathies or CNS stimulation or depression may occur. No information is available on the following: LD 50 ; concentration of propylthiouracil in biologic fluids associated with toxicity and/or death; the amount of drug in a single dose usually associated with symptoms of overdosage; or the amount of propylthiouracil in a single dose likely to be life-threatening.
Treatment: To obtain up-to-date information about the treatment of overdose, a good resource is the certified Regional Poison Control Center. In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in the patient. In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient’s medical status.
",,,"Store at controlled room temperature 15°-30°C
",12
+931,Propranolol Hydrochloride,propranolol-hydrochloride-931,https://medex.com.bd/attachments/wjZrvvEq5qHZ6LTywfgHS6Toc2qhZv/propranolol-hydrochloride-tablet-prescribing-information,Beta-adrenoceptor blocking drugs,Tuberculosis,"Propranolol is indicated in:
+
+- Essential hypertension
+- Angina pectoris
+- Cardiac arrhythmia
+- Thyrotoxicosis
+- Anxiety
+- Prophylaxis of migraine, etc.
+
","Beta-adrenoceptor blocking drugs, Beta-blockers
","Propranolol Hydrochloride is a B-adrenergic receptor blocking drug which is widely used in hypertension and angina pectoris. Propranolol antagonizes catecholamines at B-adrenergic receptors, thus prevents excess rate and force of contraction of the heart and decreases the excess consumption of oxygen by the heart.
Propranolol is almost completely absorbed from the gastrointestinal tract, but a portion is immediately metabolized by the liver when passing through the portal circulation. Peak plasma concentration occurs in 1 to 1.5 hours after oral administration. The plasma half-life of propranolol is from 3 to 6 hours. The metabolites of propranolol are excreted through the urine.
","Adult (above 18 years):
+
+- Hypertension: Initially 80 mg twice daily, may be increased at weekly intervals and then maintenance dose of 160-320 mg daily is recommended.
+- Angina pectoris: Initially 40 mg 2-3 times daily and then maintenance dose of 120-240 mg daily is given.
+- Thyrotoxicosis: 10-40 mg, 3-4 times daily is given.
+- Anxiety: 40 mg once daily, may be increased to three times daily.
+- Prophylaxis of migraine: Initially 40 mg 2-3 times daily; then maintenance dose of 80-160 mg daily is recommended.
+
+Child (From day 1 to 18 years): Hypertension:
+
+- Neonate: 0.25-0.5 mg/kg 3 times daily, adjusted according to response.
+- Child 1 month: 12 years: 0.25-1 mg/kg 3 times daily, maximum dose 5 mg/kg daily in divided dose.
+- Child 12-18 years: initially 80 mg twice daily, maintain 160-320 mg daily.
+
",,"Patients receiving verapamil, salbutamol, Levosalbutamol, ergot alkaloids, lidocain, phenobarbital drugs should be closely observed during therapy.
","Bronchospasm, cardiogenic shock, second or third degree heart block, diabetes mellitus etc.
","Cold extremities, lassitude, nausea, dizziness, insomnia, paresthesia etc.
","Pregnancy category C, should not be used in pregnant women. Propranolol is excreted in human milk. Caution should be taken when propranolol is administered to a nursing mother.
","It should be taken with caution in hepatic and renal impairment, pregnancy and lactating mother.
",,,,,"Store in a cool and dry place, protected from light.
",10
+929,Propofol,propofol-929,https://medex.com.bd/attachments/Jk6jeDU6sXTLcG6jGWZaiUl8P2h53s/propofol-prescribing-information,General (Intravenous) anesthetics,Sedation,"Induction and maintenance of general anaesthesia. Sedation during intensive care. Sedation for surgical and diagnostic procedures.
","General (Intravenous) anesthetics
","Propofol is a sedative-hypnotic agent for use in the induction and maintenance of anesthesia or sedation. Intravenous injection of a therapeutic dose of propofol produces hypnosis rapidly with minimal excitation, usually within 40 seconds from the start of an injection (the time for one arm-brain circulation). The action of propofol involves a positive modulation of the inhibitory function of the neurotransmitter gama-aminobutyric acid (GABA) through GABA-A receptors.
","Adults:
+Induction of general anaesthesia: The dosage of Propofol should be titrated individually against the response of the patient. The ordinary initial dosage in adults is 40 mg (4 ml) by slow intravenous bolus injection at intervals of 10 seconds until the clinical signs show the onset of anaesthesia. The ordinary induction dose in healthy patient below 55 years of age is 2.2-2.5 mg/kg. A dose of 1.0-1.5 mg/kg is often sufficient for older patient. Lower doses, most often 20 mg (2 ml) at intervals of 10 seconds, are recommended for patient of ASA grades 3 and 4.
Maintenance of general anaesthesia: Anaesthesia can be maintained by administering Propofol either by continuous infusion or by repeat bolus injections to maintain sufficient anaesthesia.
Continuous infusion: The required rate of infusion varies considerably between patients. At the onset of anaesthesia (during roughly the first 10-20 minutes), some patient may require a slightly higher infusion rate (8-10 mg/kg/h). However, sufficient anaesthesia is normally achieved by infusing 4-6 (up to 12) mg/kg/h of Propofol. Repeat bolus injections: 25-50 mg (2.5-5.0 ml) bolus injections, depending on response.
Sedation during intensive care: A bolus injection of 1.0-2.0 mg/kg should be given first, followed by continuous infusion adjusted according to required degree of sedation. An infusion rate of 0.3-4 mg/kg/h is usually sufficient.
Sedation for surgical and diagnostic procedures: Dosages shall be adjusted individually. Sufficient sedation for surgical and diagnostic procedures can usually be achieved by administering initially 0.5-1 mg/kg during 1-5 minutes, and maintained by continuous at a rate of 1-4.5 mg/kg/h. Bolus dose of 10-20 mg can be given in addition, should deeper sedation be suddenly required. Lower doses of Propofol are often sufficient for patient of ASA grades 3 and 4, and for older patient.
+Children:
+Propofol is not recommended for use in children less then 3 years of age as its safety has not been demonstrated.
Induction of general anaesthesia: Dosage of Propofol in children shell be adjusted for weight and age. The mean induction dosage in children over 8 years is 2.5 mg/kg, given by slow intravenous injection until the clinical signs show the onset of anaesthesia. Younger children may need slightly higher doses of propofol per kilogram of weight. Lower dosages are recommended for children of ASA grades 3 and 4.
Maintenance of general anaesthesia: Anaesthesia can be maintained by administering Propofol either by continuous infusion or by repeat bolus injections. Dosage shall be adjusted individually, but an infusion rate of 9-15 mg/kg/h is usually sufficient to achieve satisfactory anaesthesia.
Sedation during intensive care, surgical diagnostic procedures: Propofol is not recommended for sedation in children as its efficacy and safety have not been demonstrated. Although no casual relationship has been established, serious adverse events (including fatalities) have been reported in cases, where propofol has been used against recommendations. Adverse events have most commonly been seen in children with respiratory tract infections given doses in excess of those recommended for adults.","Method of administration: In order to reduce pain on injection, the induction dose of propofol may be mixed immediately before injection in the palstic syringe with lidocaine 10 mg/ml injection, in a ratio of 1 part of lidocaine injection for 20 parts of Propofol.
Propofol can be administered either undiluted or diluted for infusion. Before injection or dilution, each ampoule or vial shall be ispected for any irregularity. Should any changes be observed, the product shall not be used. Suitable equipment shall be used to ensure correct rate of infusion. Volumetric infusion pumps and syringe pumps, for example, are suitable for this purpose. The ordinary infusion set used alone is not sufficient to prevent accidential overdosage reliably enough.
Compatibility: Propofol may be diluted only with 5% dextrose infusion. Dilution shall not exceed 1 in 5 (containing 2 mg/ml Propofol) and shall be prepared in a PVC infusion bag or glass infusion bottle. If a PVC infusion bag is used, the bag should be full and the dilution be prepared by withdrawing a volume of infusion fluid and replacing it with an equal volume of Propofol. Special attention shall be paid to preparing the dilution aseptically, immediately before administration. Any diluted solution shall be used within 6 hours of preparation. Any remaining solution shall be discarded.
","Propofol has been used in association with spinal and epidural anaesthesia as well as with various types of premedicants, muscle relaxants, inhalation anaesthetics and analgetics. No pharmacological incompatibility has been observed. Lower doses of Propofol may be sufficient in case Propofol is used as an adjunct to local anaesthetic techniques. In doses applied clinically, propofol will not inhibit the synthesis of adrenocortical hormones. Simultaneous administration of opiates may potentiate respiratory depression caused by Propofol.
","Allergy to propofol or any other ingredient in the preparation.
","Local: Propofol is normally well tolerated. Its most common undesirable effect is pain at the site of injection that can be reduced by mixing the preparation with lidocaine or by injecting it into one of the larger veins of the forearm or the intercubital fossa. Thrombosis and phlebitis are rare.
General: Hypotension and transient apnea may occur at the induction of anaesthesia, and may be severe especially in patients who are in a poor general condition. Epileptic movement, convulsions and dystonic reactions have been seen in rare cases. Pulmonary oedema has also been reported. Headache, nausea and, more rarely, vomiting may occur in some patients during recovery. Recovery may also be associated with another short period of impaired consciousness. Hypersensitivity has been reported in some cases, connected with anaphylactic symptoms such as marked hypotension, bronchospasm, oedema and facial erythema. Some cases of cardiac arrest have occurred in connection with the administration of propofol. In connection with long-term administration of propofol, green or reddish brown discolouration of urine may occur. This is caused by the quinol metabolites of propofol, and is not dangerous. As with other anaesthetics, altered sexual behaviour may occur.
","Due to insufficient experience, propofol shall not be used during pregnancy. Propofol is rapidly distributed to the foetus and shall therefore not be used for obstetric anaesthesia. Safety to the neonate has not been established in cases, where propofol has been administered to lactating women.
","Propofol should only be given by specialists in anaesthesiology or under their supervision. The physician performing a surgical or diagnostic procedure should not administer propofol. Facilities for resuscitation in case of any complication should be available at the treatment unit. During the administration of Propofol, patients shall be monitored continuously to observe possible hypotension, obstruction in the respiratory tract, hypoventilation or insufficient oxygen intake at a sufficiently early stage. Special attention shall be paid to patients sedated by Propofol for a surgical or diagnostic procedure, who are not artificially ventilated. Caution shall be taken in administering Propofol to patients with cardiac, respiratory, renal or hepatic insufficiency. Hypovolemic patients and those with poor general condition form another risk group.
Since propofol lacks vagolytic activity, bradycardia, even asystole, may occur. Intravenous administration of an anticholinergic agent before induction and during maintenance of anaesthesia should be considered, especially if propofol is used in conjunction with other agents likely to cause bradycardia and in situations where vagal tone is likely to predominate. Since Propofol is a lipid emulsion, appropriate care should be applied in patients with severe disorders of fat metabolism such as pathological hyperlipidemia. If Propofol is administered to a patient for whom excessive fat intake may be risky, blood lipid values shall be monitored and Propofol dosage decreased if necessary. If the patient is receiving other paranteral lipid emulsions in addition to Propofol, the amount of lipid in Propofol (0.1 g/ ml) shall be taken into account, when calculating the total intake of fat. In epileptic patients, propofol may lead to convulsions. The analgetic effect of propofol as such is insufficient. Analgetics shall be used to ensure sufficient analgesia. Full recovery from general anaesthesia shall be confirmed prior to discharge. It shall be noted that the aftermath of general anaesthesia may impair the patient's ability to understand instructions given postoperatively.
","Use in children: Propofol is not recommended for use in children less then 3 years of age as its safety has not been demonstrated.
","Overdosage may cause cardiorespiratory depression. Respiratory depression should be treated by artificial ventilation with oxygen, and cardiovascular depression by lowering of the patient's head and elevating of his/her legs. Pressor agents and plasma expanders or Ringer-type electrolyte solutions may be used, if necessary.
",,"Propofol should not be mixed prior to intravenous injection with solutions or infusion fluids other than 5% dextrose or lidocaine 10 mg/ml injection.
","Propofol should be stored at a temperature not exceeding 25º C. It must not be frozen. Any unused solution shall be discarded.
",14
+954,Ribavirin,ribavirin-954,https://medex.com.bd/attachments/1hWPLXRTWPy0S3UsrjCckknpUTZ5AU/ribavirin-prescribing-information,Hepatic viral infections (Hepatitis C),Chronic hepatitis C,"Ribavirin is indicated for the treatment of chronic hepatitis C (CHC) virus infection in combination with other antiviral drugs in patients with compensated liver disease not previously treated with interferon alpha and in adult CHC patients coinfected with HIV. Ribavirin should not be used alone.
","Hepatic viral infections (Hepatitis C)
","Ribavirin is a synthetic nucleoside which has inhibitory action against respiratory syncytial virus, influenza virus and herpes simplex virus. The mechanism of action is not clear. It may act at several sites including cellular enzymes to interfere with viral nucleic acid synthesis. The mono- and triphosphate derivatives are known to be responsible for the antiviral action of the compound.
","The recommended duration of treatment for patients previously untreated with interferon is 24 to 48 weeks. After 24 weeks of treatment virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV RNA below the limit of detection of the assay by 24 weeks. There are no safety and efficacy data on treatment for longer than 48 weeks in the previously untreated patient population. In patients who relapse following interferon therapy, the recommended duration of treatment is 24 weeks. There are no safety and efficacy data on treatment for longer than 24 weeks in the relapse patient populations.
Ribavirin + Interferon: Genotype Ribavirin Daily Interferon alpha-2a Duration or interferon alpha-2b.
+
+- All <75 kg: (400+600) mg 3 MIU 3 times weekly 48 weeks Genotypes subcutaneously (Genotype1&4)
+- >75 kg: (600+600) mg 24 weeks (Genotype2&3)
+
+
Ribavirin + Peg-Interferon: Genotype Ribavirin Daily Peg-Interferon alpha-2a Duration or Peg-interferon alpha-2b:
+
+- 1 & 4 < 75 kg: (400+600) mg 180 gm once weekly 48 weeks
+- > 75 kg: (600+600) mg subcutaneously 2 & 3 (400+400) mg 24 weeks
+
+Ribavirin may be administered without regard to food, but should be administered in a consistent manner. Drink plenty of water while being treated with this medication; drinking water will decrease the risk of serious side effects.
",,"Nucleoside reverse transcriptase inhibitors or reduce dose or discontinue interferon, ribavirin or both with worsening toxicities
Azathioprine: Concomitant use of azathioprine with ribavirin has been reported to induce severe pancytopenia and may increase the risk of azathioprine-related myelotoxicity.
","Women who are pregnant. Ribavirin may cause fetal harm when administered to a pregnant woman. Ribavirin is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Patients with hemoglobinopathies (e.g., thalassemia major or sickle-cell anemia). In combination with didanosine. Reports of fatal hepatic failure, as well as peripheral neuropathy, pancreatitis and symptomatic hyperlactatemia/lactic acidosis have been reported in clinical trials.
","The most common adverse reactions in adults receiving combination therapy are psychiatric and central nervous system effects, severe ocular disorder, dental and periodontal disorders & growth inhibition in children and adolescents that may be irreversible in some patients. The most common adverse reactions in pediatric subjects were similar to those seen in adults.
","Pregnancy Category X. Ribavirin produced significant embryocidal and/or teratogenic effects in all animal species in which adequate studies have been conducted. Malformations of the skull, palate, eye, jaw, limbs, skeleton and gastrointestinal tract were noted. The incidence and severity of teratogenic effects increased with escalation of the drug dose. Survival of fetuses and offspring was reduced.
Nursing Mothers: It is not known whether Ribavirin is excreted in human milk. Because many drugs are excreted in human milk and to avoid any potential for serious adverse reactions in nursing infants from ribavirin, a decision should be made either to discontinue nursing or therapy with Ribavirin, based on the importance of the therapy to the mother.
","Birth defects and fetal death with ribavirin: Do not use in pregnancy and for 6 months after treatment. Patients must have a negative pregnancy test prior to therapy, use at least 2 forms of contraception and undergo monthly pregnancy tests. For a male patient, it is very important for his female partner to avoid becoming pregnant during treatment and during the 7 months after treatment and do not have sex with a pregnant women.
","Pediatric Use: Safety and effectiveness of Ribavirin in combination with Peginterferon has not been established in pediatric patients below the age of 3 years.
Geriatric Use: The risk of toxic reactions to this drug may be greater in patients with impaired renal function. The dose of Ribavirin should be reduced in patients with creatinine clearance less than or equal to 50 ml/min; and the dose of Interferon should be reduced in patients with creatinine clearance less than 30 ml/min.
",,,,"Keep out of the reach of children. Keep in a cool & dry place. Protect from light.
",11
+1043,Rhubarb Extract + Salicylic Acid,rhubarb-extract-salicylic-acid-1043,,Oral preparations,Teething pain,"This oral solution is indicated in the treatment of acute and chronic inflammations of the mucosas of the mouth, gums and throat (Aphthous Ulcer, Cold Sore, Gingivitis, Periodontitis, Dental Hypersensitivity, Dental Plaque, Denture Irritation).
","Oral preparations
","Salicylic acid works by blocking the action of a substance in the body called cyclo-oxygenase. This extract contains anthraquinone glycosides, which relieve inflammation. This is well absorb into the oral mucosa.
","Adults: To be applied to the inflamed oral mucosa (after removing any dentures) 3 to 4 times daily using the brush provided. Avoid rinsing the mouth or eating for 15 minutes after application. Always keep the cap closed immediately after every use.
Children: As per consultation with a registered physician, it is recommended below the age of 12 years.
",,"There are no known interactions with the preparation documented.
","Hypersensitivity to any of the constituents.
","A transient local burning sensation at the site of application occurs very commonly. Temporary discoloration of teeth or oral mucosa has been described commonly following administration of the oral solution.
","Pregnancy: Animal studies are insufficient with respect to effects on pregnancy and-or embryonal/foetal development. The potential risk for humans is unknown. Caution should be exercised when prescribing to pregnant women.
Lactation: Anthraquinone glycosides derived from rhubarb may be excreted in breast milk. However, at therapeutic doses of oral solution, it is not known whether these or salicylic acid are excreted in breast milk. A decision on whether to continue breast feeding or to continue therapy with an oral solution should be made taking into account the benefit of breast-feeding to the child and benefit of oral solution therapy to the woman.
","Each bottle of the oral solution should be used by only one person.
",,"Overdose associated with a local application is unlikely, although the extent of systemic absorption of salicylic acid and anthraquinone derivatives is not known. Systemic overdose following ingestion might lead to abdominal cramping, diarrhea, and possibly salicylism (presenting as hyperventilation, tinnitus, deafness, vasodilation, sweating).
",,,"Store in a cool and dry place, protected from light.
",11
+953,Retapamulin,retapamulin-953,https://medex.com.bd/attachments/TwJ11KZ5CVsuhnocb1kxFki8T2C8nx/retapamulin-prescribing-information,Topical Antibiotic preparations,Skin infections,"Retapamulin is indicated for use in adults and pediatric patients aged 9 months and older for the topical treatment of impetigo (up to 100 cm 2 in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) due to Staphylococcus aureus (methicillin-susceptible isolates ... Read more
Retapamulin is indicated for use in adults and pediatric patients aged 9 months and older for the topical treatment of impetigo (up to 100 cm 2 in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) due to Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes. Safety in patients younger than 9 months has not been established. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Retapamulin and other antibacterial drugs, Retapamulin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
","Topical Antibiotic preparations
","Retapamulin selectively inhibits bacterial protein synthesis by interacting at a site on the 50S subunit of the bacterial ribosome through an interaction that is different from that of other antibiotics. This binding site involves ribosomal protein L3 and is in the region of the ribosomal P-site and peptidyl transferase center. By virtue of binding to this site, pleuromutilins inhibit peptidyl transfer, block P-site interactions, and prevent the normal formation of active 50S ribosomal subunits. Retapamulin is bacteriostatic against Staphylococcus aureus and Streptococcus pyogenes at the Retapamulin in vitro minimum inhibitory concentration (MIC) for these organisms.
","A thin layer of Topibac should be applied to the affected area (up to 100 cm2 in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) twice daily for 5 days. The treated area may be covered with a sterile bandage or gauze dressing if desired.
",,"The effect of concurrent application of Retapamulin and other topical products to the same area of skin has not been studied.
","Contraindicated in patients with hypersensitivity of any ingredient of this preparation.
","Adverse effects: Application site irritation (<2% of patients may experience).
","Pregnancy Category B. It is not known whether Retapamulin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Retapamulin is administered to a nursing woman.
","Local Irritation: In the event of sensitization or severe local irritation from Retapamulin, usage should be discontinued. Not for Systemic or Mucosal Use: Retapamulin is not intended for ingestion or for oral, intranasal, ophthalmic, or intravaginal use.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+952,Repaglinide,repaglinide-952,https://medex.com.bd/attachments/dB21ohVxeF12b0DxS03fiHIRJHqv4U/repaglinide-prescribing-information,Meglitinide Analogues,Type 2 DM,"Repaglinide is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with type 2 diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled satisfactorily by diet and exercise alone. It is also indicated for use in combination with Metformin to lower blood glucose ... Read more
Repaglinide is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with type 2 diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled satisfactorily by diet and exercise alone. It is also indicated for use in combination with Metformin to lower blood glucose in patients whose hyperglycemia cannot be controlled by exercise, diet, and either Repaglinide or Metformin alone.
","Meglitinide Analogues
","Repaglinide binds to specific receptors in the cell membrane leading to the closure of ATP dependent K+ channels and the depolarisation of cell membrane. This in turn, leads to Ca++ influx, increased intracellular Ca++ and the stimulation of insulin secretion.
","
+- For patients not previously treated or whose HbA1c is <8%, the starting dose should be 0.5 mg before each meal.
+- For patients previously treated with blood glucose-lowering drugs and whose HbA1c is >8%, the initial dose is 1 or 2 mg before each meal.
+- Repaglinide should be taken immediately or up to 30 minutes before each meal.
+- Dosage should be adjusted according to response at intervals of 1-2 weeks; up to 4 mg may be given as a single-dose, maximum 16 mg daily.
+
",,"The dose of Repaglinide may need to be adjusted, if taken with other medications. The possible interactions of Repaglinide with other drugs are:
+
+- Inhibitors of the cytochrome P450 enzyme system (azole antifungals and macrolides) may lead to lower Repaglinide clearance and longer half life.
+- Inducers of the cytochrome P450 enzyme system (Rifampin, Phenobarbital, Carbamazepine, Troglitazone, etc.) may accelerate Repaglinide metabolism and shorten its effect.
+- Cimetidine has no significant effect on Repaglinide absorption or clearance.
+- Repaglinide has no significant effect on Digoxin, Theophyllin, or Warfarin.
+- Highly protein bound drugs (e.g., NSAIDs) may increase the plasma level of unbound Repaglinide and potentiate its glucose lowering effect. Thus, co-administration of these drugs with Repaglinide may increase the risk of hypoglycaemia.
+- The risk of hypoglycaemia may also be increased when hypoglycaemic agents are co-administered with certain drugs such as salicylates, sulphonamides, Chloramphenicol, coumarins, Probenecid, monoamine oxidase (MAO) inhibitors, and adrenergic blockers.
+
","Repaglinide is contraindicated in patients with:
+
+- Diabetic ketoacidosis, with or without coma.
+- Type 1 diabetes mellitus and
+- Known hypersensitivity to the drug or its inactive ingredients.
+
","The most common side effects of Repaglinide are hypoglycemia and related symptoms. Others include upper respiratory tract infections, diarrhea, constipation, nausea and vomiting. Hypersensitivity reactions include rashes and urticaria.
","Safety in pregnant women has not been established. Repaglinide should be used during pregnancy only if it is clearly needed. It is not known whether Repaglinide is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Repaglinide, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.
","Insulin should be substituted during concurrent illness (such as myocardial infarction, coma, infection, and trauma) and during surgery. All oral blood glucose-lowering drugs are capable of producing hypoglycemia. Repaglinide should be administered with meals to lessen the risk of hypoglycemia.
",,"Patients receiving up to 80 mg of Repaglinide developed few adverse effects other than lowering of blood glucose. Hypoglycemia did not occur when meals were given with these high doses. Severe hypoglycemic reactions with coma, seizure or other neurological impairment occur infrequently.
",,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",11
+1561,Remdesivir,remdesivir-1561,https://medex.com.bd/attachments/FZDp5iBIaEJeUWHc09F6fy3vM8rOWX/remdesivir-prescribing-information,Anti-viral drugs,Suspected or confirmed COVID-19,"Emergency use of Remdesivir for treatment of suspected or laboratory confirmed Corona Virus Disease 2019 (COVID-19). Severe disease is defined as patients with an oxygen saturation (Sp02) <94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal ... Read more
Emergency use of Remdesivir for treatment of suspected or laboratory confirmed Corona Virus Disease 2019 (COVID-19). Severe disease is defined as patients with an oxygen saturation (Sp02) <94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO). Specifically, Remdesivir is only authorized for hospitalized adult and pediatric patients for whom use of an intravenous agent is clinically appropriate.
","Anti-viral drugs
","Remdesivir is a preparation of Remdesivir. It is an adenosine nucleotide prodrug that distributes into cells where it is metabolized to form the pharmacologically active nucleoside triphosphate metabolite. Metabolism of Remdesivir to Remdesivir Triphosphate has been demonstrated in multiple cell types. Remdesivir Triphosphate act as an analogue of adenosine triphosphate (ATP) and competes with the natural ATP substrate for incorporation into nascent RNA chains by the SARS-CoV-2 RNA-dependent RNA polymerase, which results in delayed chain termination during replication of the viral RNA. Remdesivir triphosphate is a weak inhibitor of mammalian DNA and RNA polymerase with low potential for mitochondrial toxicity.
","General Information-
+
+- Adult and pediatric patients (>28 days and old) must have an eGFR determined and full-term neonates (≥7 days to ≤28 days old) must have serum creatinine determined before dosing of Remdesivir.
+- Hepatic laboratory testing should be performed in all patients prior to starting Remdesivir and daily while receiving Remdesivir.
+- Remdesivir should be administered via intravenous infusion only. Do not administer as intramuscular injection.
+
+Adult Patients-
+
+- The recommended dosage in adults requiring invasive mechanical ventilation and/or ECMO is a single loading dose of Remdesivir 200 mg on day 1 followed by once daily maintenance dose of Remdesivir 100 mg for 9 days.
+- The recommended dose in adults not requiring invasive mechanical ventilation and/or ECMO is a single dose of Remdesivir 200 mg on day 1 followed by once daily maintenance dose of Remdesivir 100 mg for 4 days. If a patient dose not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days)
+- Remdesivir is to be administered via intravenous infusion in a total volume of up to 250 ml 0.9% saline over 30 to 120 minutes.
+
+Pediatric Patients-
+
+- The recommended pediatric dose for pediatric patients weighing between 3.5 kg <40 kg should be calculated using the mg/kg dose according to the patient’s weight.
+- For pediatric patients with body weight between 3.5 kg <40 kg use Remdesivir for injection 100 mg lyophilized powder only. Administer a body weight-based dosing regimen of one loading dose of Remdesivir 5 mg/kg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 2.5 mg/kg IV (infused over 30 to 120 minutes) once daily for 9 days (for pediatric patients requiring invasive mechanical ventilation and/or ECMO, days 2 through 5). If a patient dose not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days)
+- For pediatric patients with body weight ≥40 kg requiring invasive mechanical ventilation and/or ECMO, the adult dosage regimen of one loading dose of Remdesivir 200 mg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 100 mg IV (infused over 30 to 120 minutes) once daily for 9 days will be administered.
+- For pediatric patients with body weight ≥40 kg requiring invasive mechanical ventilation and/or ECMO, the adult dosage regimen of one loading dose of Remdesivir 200 mg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 100 mg IV (infused over 30 to 120 minutes) once daily for 4 days (days 2 through 5) will be administered. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days).
+
","The prepared dilution should not be administered simultaneously with any other medication. The compatibility of Remdesivir injection with IV solutions and medications other than saline is not known. Please administered the diluted solution with the infusion rate described in the below table. Recommended Rate of Infusion- Diluted Remdesivir for Injection Lyophilized Powder in Adults and Pediatric Patients Weighing > 40 kg
Infusion bag 250 ml:
+
+- Infusion Time: 30 min, Rate of Infusion: 8.33 ml/min
+- Infusion Time: 60 min, Rate of Infusion: 4.17 ml/min
+- Infusion Time: 120 min, Rate of Infusion: 2.08 ml/min
+
+Infusion bag 100 ml:
+
+- Infusion Time: 30 min, Rate of Infusion: 3.33 ml/min
+- Infusion Time: 60 min, Rate of Infusion: 1.67 ml/min
+- Infusion Time: 120 min, Rate of Infusion: 0.83 ml/min
+
",,"Remdesivir is contraindicated in patients with known hypersensitivity to Remdesivir.
","An adverse reaction associated with Remdesivir in clinical trials in healthy adult subjects was increased liver transaminases.
","No adequate and well controlled studies of Remdesivir use in pregnant women have been conducted. Remdesivir should be used in pregnancy only if the potential benefit justifies the potential risk for the mother fetus. There is no information regarding the presence of Remdesivir in human milk, the effects on the breastfeed infants, or the effects on milk production. Because of the potential for viral transmission of SARS-CoV-2 negative infants and adverse reactions from the drug in breastfeeding infants, the development and health benefits of breastfeeding should be considered along with the mother's clinical need for Remdesivir and any potential adverse effects on the breastfed child from Remdesivir or from the underlying maternal condition.
","There are limited clinical data available for Remdesivir. Serious and unexpected adverse events may occur that have not been previously reported with Remdesivir use.
",,,,"Reconstitution instructions:
+
+- Aseptically reconstitute Remdesivir lyophilized powder by addition of 19 ml of sterile water for injection using a suitably sized syringe and needle per vial.
+- Discard the vial if a vacuum does not pull the sterile water for injection into the vial.
+- Immediately shake the vial for 30 seconds.
+- Allow the contents of the vial to settle for 2 to 3 minutes. A clear solution should result.
+- If the content of the vial is not completely dissolved, shake the vial again for 30 seconds and allow the contents to settle for 2 to 3 minutes. Repeat this procedure as necessary until the contents of the vial are completely dissolved.
+- Following reconstitution, each vial contains 100 mg/20 ml (5 mg/ml).
+- Parenteral drug products should be inspected virtually for particulate matter and and discoloration prior to administration, whenever solution and container permit.
+
","Please do not reuse or save unused Remdesivir Lyophilized powder, injection solution or diluted solution for infusion for further use. This product contains no preservatives.
Lyophilized Powder: Please store Remdesivir for injection, 100 mg, vials at temperature not exceeding 30°C in a dry place until required for use. Protect from light & moisture. Do not use after expiration date.
After reconstitution: vials can be stored up to 4 hours at room temperature (20°C-25°C) prior to administration or 24 hours at refrigerated temperature (2°C-8°C). Please dilute within the same day as administration.
Diluted Solution for Infusion: Please store diluted Remdesivir solution for infusion up to 4 hours at room temperature (20°C-25°C) or 24 hours at refrigerated temperature (2°C-8°C).
",11
+2061,Relugolix,relugolix-2061,https://medex.com.bd/attachments/62hpLVQBox0RsuPTJEY4FvJs6m9ve5/relugolix-prescribing-information,Gonadotropin-releasing hormone (GnRH) antagonist,,"Relugolix tablet is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer.
","Gonadotropin-releasing hormone (GnRH) antagonist
","Relugolix is a non-peptide small molecule, GnRH receptor antagonist. Relugolix competitively binds to pituitary GnRH receptors, thereby, reducing the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), and consequently testosterone.
Absorption: Relugolix is a substrate for intestinal P-gp. The mean (CV%) absolute bioavailability of Relugolix is approximately 12%. The median (range) Tmax of Relugolix is 2.25 hours.
Effect of Food: No clinically meaningful differences in the pharmacokinetics of Relugolix were observed following consumption of a high-calorie, high-fat meal.
Distribution: Plasma protein binding of Relugolix is 68 to 71%, primarily to albumin and to a lesser extent to α1- acid glycoprotein. The mean blood-to-plasma ratio is 0.78.
Elimination: The mean effective half-life of Relugolix is 25 hours and the mean (CV %) terminal elimination half-life is 60.8 (11%) hours. The mean (CV %) total clearance of Relugolix is 29.4 (15%) L/h and the renal clearance is 8 L/h.
Metabolism: Relugolix is metabolized primarily by CYP3A and to a lesser extent by CYP2C8 in vitro.
Excretion: After oral administration of a single 80mg radiolabeled dose of Relugolix, approximately 81% of the radioactivity was recovered in feces (4.2% as unchanged) and 4.1% in urine (2.2% as unchanged).
","A loading dose of 360 mg on the first day of treatment followed by 120 mg taken once daily, at approximately the same time each day. Relugolix Tablet can be taken with or without food. Advise patients to take a missed dose of Relugolix as soon as they remember. If the dose was missed by more than 12 hours, patients should not take the missed dose and resume with the next scheduled dose. If treatment with Relugolix is interrupted for greater than 7 days, restart Relugolix with a loading dose of 360 mg on the first day, and continue with a dose of 120 mg once daily.
Pediatric Use: The safety and efficacy of Relugolix in pediatric patients have not been established.
Geriatric Use: No overall differences in safety or effectiveness were observed between older and younger subjects.
",,"P-gp Inhibitors: Avoid co-administration. If unavoidable, take Relugolix first, separate dosing by at least 6 hours, and monitor patients more frequently for adverse reactions. Combined P-gp and
Strong CYP3A Inducers: Avoid co-administration. If unavoidable, increase the Relupros ® dose to 240 mg once daily.
",,"Adverse Reactions: The most common adverse reactions (≥10%) and laboratory abnormalities (≥15%) were hot flushes, glucose increased, triglycerides increased, musculoskeletal pain, haemoglobin decreased, alanine aminotransferase (ALT) increased, fatigue, aspartate aminotransferase (AST) increased, constipation, and diarrhea.
Common Side Effects: Hot flushes, Increased blood sugar levels, Increased blood fat (triglyceride) levels, Muscle and joint pain, Decreased hemoglobin levels, Increased liver enzymes, Tiredness, Constipation, Diarrhoea
Rare Side Effects: Relugolix may cause rare side effects, including Changes in the electrical activity of your heart (QT prolongation), Dizziness, Fainting, Feeling that your heart is pounding or racing (palpitations), Chest pain. Other side effects include weight gain, decreased sex drive, and erectile function problems.
","The safety and efficacy of Relugolix at the recommended dose of 120 mg daily have not been established in females. Females and Males of Reproductive Potential. Based on findings in animals and mechanism of action, Relugolix may impair fertility in males of reproductive potential.
","QT/QTc Interval Prolongation: Androgen deprivation therapy may prolong the QT interval.
Embryo-Fetal Toxicity: Relugolix can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception.
",,"There is no specific experience in the management of Relugolix overdose in patients.
",,,"Store in a cool and dry place, protect from light & moisture. Keep all medicines out of the reach of children.
",10
+1381,Regorafenib,regorafenib-1381,https://medex.com.bd/attachments/uS5YWdUWAhFKN9D9pWDW83JzWBQxu2/regorafenib-prescribing-information,Targeted Cancer Therapy,Hepatocellular Carcinoma,"Regorafenib is a kinase inhibitor that is indicated:
+
+- For the treatment of metastatic colorectal cancer (CRC) after disease progression on or intolerance to fluoropyrimidine-based chemotherapy, anti-VEGF therapy and anti-EGFR therapy.
+- For the treatment of unresectable or metastatic gastrointestinal stromal tumours (GIST) after disease progression on or intolerance to prior treatment with imatinib and sunitinib.
... Read more
Regorafenib is a kinase inhibitor that is indicated:
+
+- For the treatment of metastatic colorectal cancer (CRC) after disease progression on or intolerance to fluoropyrimidine-based chemotherapy, anti-VEGF therapy and anti-EGFR therapy.
+- For the treatment of unresectable or metastatic gastrointestinal stromal tumours (GIST) after disease progression on or intolerance to prior treatment with imatinib and sunitinib.
+- For the treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib
+
","Targeted Cancer Therapy
","Regorafenib is a kinase inhibitor and it inhibits multiple membrane-bound and intracellular kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, and maintenance of the tumor microenvironment. Regorafenib or its major human active metabolites M-2 and M-5 inhibits the activity of RET, VEGFR1, VEGFR2, VEGFR3, KIT, PDGFR-alpha, PDGFR-beta, FGFR1, FGFR2, TIE2, DDR2, Trk2A, Eph2A, RAF-1, BRAF, BRAFV600E, SAPK2, PTK5, and Abl. Due to its inhibitory functions, regorafenib can inhibit the progression of certain solid tumors.
","Metastatic colorectal cancer (CRC): 160 mg orally, once daily for the first 21 days of each 28-day cycle.
Gastrointestinal stromal tumours (GIST): 160 mg orally, once daily for the first 21 days of each 28-day cycle.
Hepatocellular carcinoma (HCC): 160 mg orally, once daily for the first 21 days of each 28-day cycle.
",,"CYP3A4 Inhibitors: Avoid concomitant use of strong CYP3A4 inhibitors with Regorafenib.
CYP3A4 Inducers: Avoid concomitant use of strong CYP3A4 inducers with Regorafenib.
",,"The most common side effects (≥30%) are asthenia/fatigue, decreased appetite and food intake, hand-foot skin reaction (HFSR) [palmar-plantar erythrodysesthesia (PPE)], diarrhea, mucositis, weight loss, infection, hypertension, and dysphonia.
","Regorafenib is Pregnancy Category D. Based on its mechanism of action, Regorafenib can cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies with Regorafenib in pregnant women. Based on animal reproduction studies Regorafenib was seen to cause embryo lethal and teratogenic defects and also increased the incidences of cardiovascular, genitourinary, and skeletal malformations in animals. Advice pregnant women or women with reproductive potential of the potential hazards of Regorafenib to the fetus. There is no information regarding the presence of regorafenib or its metabolites being excreted in human milk. Regorafenib and its metabolites were excreted in rat milk and because of the potential for serious adverse reactions in nursing infants from Regorafenib, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
","
+- Hemorrhage: Permanently discontinue regorafenib for severe or life-threatening hemorrhage.
+- Dermatological toxicity: Interrupt and then reduce or discontinue regorafenib depending on severity and persistence of dermatologic toxicity.
+- Hypertension: Temporarily or permanently discontinue regorafenib for severe or uncontrolled hypertension.
+- Cardiac ischemia and infarction: Withhold regorafenib for new or acute cardiac ischemia/infarction and resume only after resolution of acute ischemic events.
+- Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue regorafenib.
+- Gastrointestinal perforation or fistulae: Discontinue regorafenib.
+- Wound healing complications: Stop regorafenib before surgery. Discontinue in patients with wound dehiscence.
+- Embryofetal toxicity: Can cause fetal harm. Advise women of potential risk to a fetus.
+
","Pediatric Use: The safety and effectiveness of Regorafenib in pediatric patients less than 18 years have not been established.
Geriatric Use: No overall differences in safety or effectiveness were observed between adult subjects and younger subjects.
Hepatic Impairment: No clinically important differences in the mean exposure of regorafenib or the active metabolites M-2 and M-5 were observed in patients with hepatocellular carcinoma and mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment compared to patients with normal hepatic function. No dose adjustment is recommended in patients with mild or moderate hepatic impairment. Closely monitor patients with hepatic impairment for adverse reactions. Regorafenib is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C) as it has not been studied in this population.
Renal Impairment: No dose adjustment is recommended for patients with mild renal impairment. Limited pharmacokinetic data are available from patients with moderate renal impairment (CLcr 30-59 mL/min/1.73m2). Regorafenib has not been studied in patients with severe renal impairment or end-stage renal disease.
Females and Males of Reproductive Potential: Contraception: Use effective contraception during treatment and up to 2 months after completion of therapy.
Infertility: There are no data on the effect of regorafenib on human fertility. Results from animal studies indicate that regorafenib can impair male and female fertility
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+1856,Red Clover [Trifolium Pratense],red-clover-trifolium-pratense-1856,,Miscellaneous topical agents,Antioxidant,"Red Clover is indicated in-
+
+- Menopausal hot flashes, night sweats, redness
+- Mood swing
+- Osteoporosis
+
","Miscellaneous topical agents
","Red Clover extracts act as an estrogen agonist by binding to intracellular estradiol receptors. it was defined as an antiprogestin, due to the extract's inhibition of progesterone induction of alkaline phosphate, an end product of progestin activity. Red Clover increases uterine weight and decreased cervical mucus viscoelasticity.
Red Clover (Trifolium pratense) is a herbal extract, which is high in isoflavones (natural plant estrogens). Red Clover isoflavones mimic the action of estrogens and are widely used by women to maintain their health and vitality especially during the time of menopause. Red Clover contains 4 key isoflavones (Genistein, Daidzein, Biochanin A and Formonoetin) that help balance female hormones by mimicking the effects of estrogens in the body, which in turn help support women during menopause. Unlike traditional hormone therapy (HRT), these natural plant estrogens prefer to bond with beta estrogens receptors and show no affinity to bond with alpha estrogens receptors.
","1 or 2 capsules 1 to 3 times daily or as advised by the registered physician.
",,,"Not to be used in patients with estrogen receptor-positive neoplasias.
","General side effects may include headache, nausea and rash. Due to its coumarin derivatives, Trifolium Pratense should be used with caution in individuals with coagulation disorders or currently undergoing anticoagulation therapy.
","Not to be used during pregnancy & breastfeeding.
",,,,,,"Store in a cool and dry place. Keep away from light and children.
",8
+1610,Recombinant Follicle Stimulating Hormone (rFSH),recombinant-follicle-stimulating-hormone-rfsh-1610,,Drugs for Infertility,Polycystic ovarian syndrome,"In the Female:
+
+- Ovulation Induction: rFSH administered SC with HCG in a sequential manner, which is indicated for ovulation induction in patients who have previously received pituitary suppression.
+- Multi-follicular Development: During ART: rFSH administered SC in conjunction with HCG is indicated for multiple follicular developments (controlled ovarian stimulation) during ART cycles in patients who have previously received pituitary suppression.
... Read more
In the Female:
+
+- Ovulation Induction: rFSH administered SC with HCG in a sequential manner, which is indicated for ovulation induction in patients who have previously received pituitary suppression.
+- Multi-follicular Development: During ART: rFSH administered SC in conjunction with HCG is indicated for multiple follicular developments (controlled ovarian stimulation) during ART cycles in patients who have previously received pituitary suppression.
+- Polycystic Ovarian Syndrome (PCOS): Used to treat Polycystic Ovarian Syndrome (PCOS) related infertility
+
+In the Male: Male infertility treatment in combination with HCG Induction of Spermatogenesis in men deficient spermatogenesis due to Hypogonadotrophic-hypogonadism.
","Drugs for Infertility, Trophic Hormones & Related Synthetic Drugs
","rFSH is a Follicle Stimulating Hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, nonidentical glycoproteins designated as the α- and β subunits. The α- and β-subunits have 92 and 111 amino acids respectively, and their primary and tertiary structure are indistinguishable from those of human Follicle Stimulating Hormone. Recombinant FSH production occurs in genetically modified Chinese Hamster Ovary (CHO) cells cultured in bioreactors. Purification by immunochromatography using an antibody specifically binding FSH results in a highly purified preparation with a consistent FSH isoform profile and a high specific activity. The biological activity of rFSH is determined by measuring the increase in ovary weight in female rats. The in vivo biological activity of rFSH has been calibrated against the first International Standard for Recombinant Human Follicle Stimulating Hormone established in 1995 by the Expert Committee on Biological Standards of the World Health Organization. rFSH contains no Luteinizing Hormone (LH) activity.
","To prevent painful injections and minimize leakage from the injection site rFSH should be slowly administered subcutaneously. The subcutaneous injection site should be alternated to prevent lipoathrophy. Any unused solution should be discarded. Subcutaneous injection of rFSH may be carried out by patient or partner, provided that proper instructions are given by the physician. Self-administration of rFSH should only be performed by patients who are well motivated, adequately trained and with access to expert advice.
Dosage in Female: There are great inter and intra-individual variations in the response of the ovaries to exogenous gonadotrophins. This makes it impossible to set an uniform dosage scheme. The dosage should, therefore, be adjusted individually depending on the ovarian response. This requires ultrasonography and monitoring of estradiol levels. There should be consideration to minimize the risk of unwanted ovarian hyperstimulation. rFSH can be given either alone, or in combination with a GnRH analogue to prevent premature luteinisation. In the latter case, especially when using a GnRH agonist, a higher total treatment dose of rFSH may be required to achieve an adequate follicular response. Clinical experience with rFSH is based on up to three treatment cycles in both indications. Overall experience with IVF indicates that in general the treatment success rate remains stable during the first four attempts and gradually declines thereafter.
Ovulation Induction in Women: Starting daily dose of 75 international units (IU) of rFSH is administered subcutaneously or subcutaneous for at least the first 7 days. The dose is increased by 25 or 75 international units (IU) at weekly intervals until follicular growth and/or serum estradiol levels indicate an adequate response. When an acceptable pre-ovulatory state is achieved, final oocyte maturation is achieved with 5000 to 10,000 international units (IU) of human chorionic gonadotropin (HCG). The woman and her partner should have intercourse daily, beginning on the day prior to the administration of HCG and until ovulation becomes apparent.
Assisted Reproductive Technology (ART): In Women, Starting dose of 150 to 300 international units (IU) of rFSH is administered subcutaneous for at least the first 4 days of treatment. Subsequent doses are adjusted based upon ovarian response as determined by ultrasound evaluation of follicular growth and serum estradiol levels. Final oocyte maturation is induced with a dose of 5000-10000 international units of HCG Oocyte (egg) retrieval is performed 34 to 36 hours later.
PCOS: rFSH injections are therefore given each morning as a subcutaneous injection. It is best to start with the lowest dose of rFSH per day (using 75 IU per day). These doses are used for 4 to 6 days at a time. The ovarian response is determined by measuring estrogen levels in the blood. When the estrogen begins to rise, the rFSH is successfully growing an egg or eggs. If there is no response to a dose of rFSH in 5-6 days of injections the dose will be increased. The normal dose increments are 75 units, 100 units, 150 units and 300 units per day. Most patients respond with 75 IU to 150 IU per day. However it is very important that increments are only made cautiously.
Dosage in Male: Induction of Spermatogenesis in Men: Pre-treatment with HCG alone (2500 international units twice weekly) is required. If serum testosterone levels have not normalized after 8 weeks of HCG treatment, the dose may be increased to 5000 international units (IU) twice a week. After normalization of serum testosterone levels, administer 300 international units (IU) per week (300 international units twice weekly or 100 international units three times weekly) of rFSH subcutaneously with the same pre-treatment HCG dose used to normalize testosterone level.
","rFSH administered for 7 to 12 days produces ovarian follicular growth in women who do not have primary ovarian failure. Treatment with rFSH in most instances results only in follicular growth and maturation. When sufficient follicular maturation has occurred, HCG must be given to induce ovulation.
",,"
+- Tumors of the ovary, breast, uterus, pituitary or hypothalamus
+- Pregnancy or lactation
+- Undiagnosed vaginal bleeding
+- Hypersensitivity to the active substance or to any of the excipients
+- Primary ovarian failure
+- Fibroid tumors of the uterus incompatible with pregnancy
+- Primary testicular failure.
+
","Recombinant FSH sometimes excites the ovaries too much. This may cause pelvic pain or breathing problems. It may also make you urinate less. In rare cases, patients with this problem have had serious lung problems, including fluid in the lungs, troublebreathing, and worsening of asthma blood clots, Severe Pelvic pain, Chest pain, or Abdominal pain, Nausea, Vomiting, Sudden weight gain, Bloating, Trouble, Breathing. Recombinant FSH may cause twins or multiple births.
","Pregnancy category X. Recombinant FSH must not be used during pregnancy and lactation.
","
+- The presence of uncontrolled non gonodal endocrinopathies (e.g. thyroid, adrenal or pituitary disorders) should be excluded.
+- In pregnancies occurring after induction of ovulation with gonadotrophin preparations, there is an increased risk of multiple gestations (Multiple birth).
+- There has been no reports of hypersensitivity to Recombinant FSH, but there remains the possibility of anaphylactic responses.
+- The first injection of Recombinant FSH should be performed under direct medical supervision.
+- Since infertile women undergoing assisted reproduction and particularly IVF, often have tubal abnormalities the incidence of ectopic pregnancies might be increased. Early ultrasound confirmation that a pregnancy is intrauterine is therefore important.
+- Rates of pregnancy loss in women undergoing assisted reproduction techniques are higher than in the normal population.
+- Unwanted ovarian hyperstimulation in the treatment of female patients, ultrasonographic assessment of follicular development, and determination of oestradiol levels should be performed prior to treatment and at regular intervals during treatment. Apart from the development of a high number of follicles, oestradiol levels may rise very rapidly, e.g. more than a daily doubling for two or three consecutive days, and possibly reaching excessively high values. The diagnosis of ovarian hyperstimulation may be confirmed by ultrasound examination. If this unwanted ovarian hyperstimulation occurs (i.e. not as part of controlled ovarian hyperstimulation in medically assisted reproduction programs), the administration of Recombinant FSH should be discontinued. In that case pregnancy should be avoided and HCG must be withheld, because it may induce in addition to multiple ovulation, the Ovarian Hyperstimulation Syndrome (OHSS).
+- In men, semen analysis is recommended 4 to 6 months after the beginning of treatment in assessing the response.
+
",,"No data on acute toxicity of Recombinant FSH in humans is available, but the acute toxicity of Recombinant FSH and of urinary gonadotrophin preparations in animal studies have been shown to be very low. Too high a dosage of Recombinant FSH may lead to hyperstimulation of the ovaries
",,"To prepare the solution, inject 1 ml water for injection into the vial of 75 IU rFSH. Do not shake, but gently swirl until the solution is clear. Generally, rFSH dissolves immediately. Check the liquid in the container; if it is not clear or contains particles, do not use it. For patients requiring a single injection from multiple vials of rFSH up to 3 vials can be reconstituted with 1 ml water for injection. This can be accomplished by reconstituting a single vial as described above. Then draw the entire contents of the first vial into a syringe and inject the contents into a second vial of lyophilized rFSH. Gently swirl the second vial, once again checking to make sure the solution is clear and free of particles. This step can be repeated with 1 additional vial for a total up to 4 vials (300 IU) of 75 IU rFSH.
","Store at 2°C-8°C (in refrigerator). Do not keep in deep freeze. Keep out of reach of children.
",12
+1496,Rasagiline,rasagiline-1496,,Antiparkinson drugs,Parkinson’s disease,"Rasagiline is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease as initial monotherapy, and as adjunct therapy to dopamine agonists or to levodopa.
","Antiparkinson drugs
","Rasagiline is a potent, irreversible, selective MAO-B inhibitor that effectively crosses the blood brain barrier after oral administration. The precise mechanisms of action of Rasagiline are unknown. One mechanism is believed to be related to its MAO-B inhibitory activity, which causes an increase in extracellular levels of dopamine in the brain. The elevated dopamine level and subsequent increased dopaminergic activity are likely to mediate Rasagiline's beneficial effects.
","Monotherapy: Rasagiline 1 mg once daily
As adjunct without Levodopa: Rasagiline 1 mg once daily
As adjunct to Levodopa: Rasagiline 0.5 mg once daily
",,"Concomitant use of Rasagiline with meperidine, dextromethorphan, antidepressants is not recommended.
","Rasagiline is contraindicated for use with meperidine, tramadol, methadone, propoxyphene and MAO inhibitors (MAOIs), including other selective MAO-B inhibitors, because of risk of serotonin syndrome.
","Common side effects of Rasagiline include: dizziness, spinning sensation, joint pain, headache, heartburn, nausea, muscle pain etc.
","Pregnancy Category C. Rasagiline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. So, caution should be exercised when administered to a nursing woman.
","Exacerbation of hypertension may occur during treatment with Rasagiline. Medication adjustment may be necessary if elevation of blood pressure is sustained. Dose should not exceed 0.5 mg once daily for patients with mild hepatic impairment or taking concomitant Ciprofloxacin or other CYP1A2 inhibitors.
","Pediatric use: The safety and effectiveness in pediatric patients have not been established.
",,,,"Store below 30° c, protected from light and moisture. Keep all the medicines out of reach of children.
",11
+950,Ranolazine,ranolazine-950,https://medex.com.bd/attachments/ni9HCi3YezLrfDo8162vwXV83qGqAk/ranolazine-prescribing-information,Other Anti-anginal & Anti-ischaemic drugs,Chronic angina,"Ranolazine is indicated for the treatment of chronic angina. Ranolazine may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers. It has been shown to decrease angina episodes in patients with ... Read more
Ranolazine is indicated for the treatment of chronic angina. Ranolazine may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers. It has been shown to decrease angina episodes in patients with coronary artery disease on maximal doses of amlodipine. Because Ranolazine prolongs the QT interval, it should be reserved for patients who have not achieved an adequate response with other antianginal drugs.The effect on angina rate or exercise tolerance appeared to be smaller in women than men.
","Other Anti-anginal & Anti-ischaemic drugs
","Ranolazine has anti-ischemlc and antlanginal effects that do not depend upon reductions in heart rate or blood pressure.The exact mechanism of action of ranolazine is unknown. Ranolazine at therapeutic levels can inhibit the cardiac late sodium current (INa). However, the relationship of this inhibition to angina symptoms is uncertain.
The QT prolongation effect of ranolazine on the surface electrocardiogram is the result of inhibition of IKr which prolongs the ventricular action potential.
","Initiate Ranolazine dosing at 500 mg twice daily and increase to 1000 mg twice daily, if needed, based on clinical symptoms. Take Ranolazine with or without meals. Swallow Ranolazine tablets whole; do not crush, break or chew. The maximum recommended daily dose of Ranolazine is 1000 mg twice daily. If a dose of Ranolazine is missed, take the prescribed dose at the next scheduled time; do not double the next dose.
",,"CYP 3A Inhibitors: Do not use Ranolazine with strong CYP 3A inhibitors. With moderate CYP 3A inhibitors (e.g., diltiazem, verapamil, erythromycin) limit maximum dose of ranolazine to 500 mg twice daily.
CYP 3A Inducers: Do not use Ranolazine with inducers.
P-gp Inhibitors (e.g., Cyclosporin): May need to lower the Ranolazine dose based on clinical dose.
Drugs transported by P-gp or metabolized by CYP2D6 (eg., digoxin, TCA): May need reduced doses of these drugs when used with ranolazine.
","Ranolazine is contraindicated in patients:
+
+- With pre-existing QT prolongation
+- With hepatic impairment
+- Taking QT prolonging drugs
+- Taking potent and moderately potent CYP3A inhibitors such as ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir, including diltiazem.
+
","Cardiac Disorders: bradycardia, palpitations
Ear and Labyrinth Disorders: tinnitus, vertigo
Gastrointestinal Disorders: abdominal pain, dry mouth, vomiting
General Disorders and Administrative Site Adverse Events: peripheral edema
Respiratory, Thoracic, and Mediastinal Disorders: dyspnea
Vascular Disorders: hypotension, orthostatic hypotension
","Pregnancy Category C. There are no adequate studies assessing the effect of ranolazine on the developing fetus. There are no adequate well-controlled studies in pregnant women. Ranolazine should be used during pregnancy only when the potential benefit to the patient justifies the potential risk to the fetus.lt is not known whether ranolazine is excreted in human milk. Because of the potentiality for serious adverse reactions from ranolazine in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Ranolazine, taking into account the importance of the drug to the mother.
","Ranolazine blocks QTc and prolongs the QTc interval in a dose-related manner. Clinical experience in an acute coronary syndrome population did not show an increased risk of proarrhythmia or sudden death.
Co-administration of ranolazine with digoxin increases the plasma concentrations of digoxin by approximately 1.5-fold and the dose of digoxin may have to be reduced accordingly. The dose of other P-gp substrates may have to be reduced as well when ranolazine Is co-admlnistered. Caution should be exercised when co-adminlstering ranolazine with P-gp inhibitors such as ritonavir or cydosporine.
","Pediatric use: Safety and effectiveness in pediatric patients have not been established.
Renal Impairment:
+
+- Mild to moderate (CrCl 30-80 mL/min): Dose titration needed
+- Severe (CrCl <30 mL/min): Contraindicated
+
+Hepatic Impairment:
+
+- Mild: Dose titration needed
+- Moderate to severe: Contraindicated
+
","Symptoms: Dizziness, nausea, vomiting, diplopia, lethargy, syncope, severe tremor, incoordination, dysplasia, hallucination.
Management: Symptomatic and supportive treatment.
",,,"Store Ranolazine tablets at 25°C with excursion permitted to 15° to 30°C. Protect from light and moisture.
",12
+949,Ranitidine Hydrochloride,ranitidine-hydrochloride-949,https://medex.com.bd/attachments/6MWmCdNUsi9UcvovRLI0gm5lM76vZP/ranitidine-hydrochloride-tablet-syrup-prescribing-information,H2 receptor antagonist,Zollinger-Ellison syndrome,"Ranitidine is indicated in:
+
+- Treatment of active duodenal ulcer
+- Benign gastric ulcer
+- Treatment & prevention of ulcer associated with non-steroidal anti-inflammatory agent
+- Post operative stress ulcer.
+- Zollinger-Ellison Syndrome.
+- Gastroesophageal reflux disease (GERD).
... Read more
Ranitidine is indicated in:
+
+- Treatment of active duodenal ulcer
+- Benign gastric ulcer
+- Treatment & prevention of ulcer associated with non-steroidal anti-inflammatory agent
+- Post operative stress ulcer.
+- Zollinger-Ellison Syndrome.
+- Gastroesophageal reflux disease (GERD).
+- Gastro-intestinal haemorrhage from stress ulcer in seriously ill patient.
+- Recurrent haemorrhage in patients with bleeding peptic ulcer.
+- Before general anesthesia in patient considered to be at risk of acid aspiration particulary obstetric patients.
+
","H2 receptor antagonist
","Ranitidine competitively blocks histamine at H2-receptors of the gastric parietal cells which inhibits gastric acid secretion. It does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion or serum gastrin.
","Ranitidine Tablet & Syrup:
+Duodenal and gastric ulcer: The usual dosage is 150 mg twice daily taken in the morning and evening or 300 mg as a single daily dose at night for 4 to 8 weeks.
Reflux oesophagitis: 150 mg twice daily or 300 mg at bed time for up to 8 weeks.
Zollinger Ellison syndrome: 150 mg 3 times daily and increased if necessary up to 6 g daily in divided doses. Dosage should be continued as long as clinically indicated.
Episodic dyspepsia: 150 mg twice daily or 300 mg at bed time for up to 6 weeks.
Maintenance: 150 mg at night for preventing recurrences.
Child (peptic ulcer): 2-4 mg/kg twice daily, maximum 300 mg daily.
+Ranitidine IV injection & IV Infusion:
+Ranitidine injection may be given either as a slow (over a period of at least two minutes) intravenous injection of 50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may be repeated every six to eight hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals; or as an intramuscular injection of 50 mg (2 ml) every six to eight hours. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences.
In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patient sapriming dose of 50 mg as low as intravenous injection followed by a continuous intravenous infusion of 0.125-0.250 mg/kg/hour may be preferred. In patients considered to be at risk of developing aspiration syndrome Ranitidine injection 50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.
Children: The recommended oral dose for the treatment of peptic ulcer in children is 2 mg/kg to 4 mg/kg twice daily to a maximum of 300 mg ranitidine per day. Safety and effectiveness of Ranitidine injection have not been established in case of children.",,"Delayed absorption and increased peak serum concentration with propantheline bromide. Ranitidine minimally inhibits hepatic metabolism of coumarin anticoagulants, theophylline, diazepam and propanolol. May alter absorption of pH-dependent drugs (e.g. ketoconazole, midazolam, glipizide). May reduce bioavailability with antacids.
","Patients hypersensitive to Ranitidine
","Ranitidine is well tolerated and side effects are usually uncommon. Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or joint pain have rarely been reported.
","Pregnancy: Ranitidine crosses the placenta. But there is no evidence of impaired fertility or harm to the foetus due to Ranitidine. Like other drugs, Ranitidine should only be used during pregnancy if considered essential.
Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
","Ranitidine should be given in reduced dosage to patients with impaired renal and hepatic function.
","Use in elderly patients: In clinical trial the ulcer healing rates have been found similar in patients age 65 and over with those in younger patients. Additionally, there was no difference in the incidence of adverse effects.
","Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If required, the drug may be removed from the plasma by haemodiaiysis.
",,"Slow IV inj: Ranitidine 50 mg diluted to a concentration ≤2.5 mg/mL (e.g. total of 20 mL) with NaCl 0.9% inj or dextrose 5% or 10%, lactated Ringer's, Na bicarbonate 5% soln.
Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
","Store in a cool and dry place. protect from light.
",13
+948,Ranibizumab,ranibizumab-948,https://medex.com.bd/attachments/nGZb72diiG4xRQJTsZG74l1nk3mpv9/ranibizumab-prescribing-information,Drugs for Age-Related Macular Degeneration (AMD),Wet age-related macular degeneration,"Ranibizumab is indicated for the treatment of patients with:
+
+- Neovascular (Wet) Age-Related Macular Degeneration (AMD)
+- Macular Edema Following Retinal Vein Occlusion (RVO)
+- Diabetic Macular Edema (DME)
+- Diabetic Retinopathy (Non Proliferative Diabetic Retinopathy (NPDR), Proliferative Diabetic Retinopathy (PDR)) in patients with Diabetic Macular Edema (DME)
+- Myopic Choroidal Neovascularization (mCNV)
+
","Drugs for Age-Related Macular Degeneration (AMD)
","Ranibizumab is a recombinant humanised IgG1 kappa monoclonal antibody fragment which binds to active forms of human vascular endothelial growth factor A (VEGF-A) and inhibits their biologic activity. Binding of ranibizumab to VEGF-A inhibits VEGF from binding to its receptors, thereby suppressing neovascularisation (angiogenesis), endothelial cell proliferation and vascular permeability.
","Intravitreal (Adult)-
Neovascular (wet) age-related macular degeneration: 0.5 mg mthly into the affected eye as a single dose. Continue treatment until visual acuity is stable for 3 consecutive mth. Doses are given at intervals of at least 1 mth.
Choroidal neovascularisation secondary to pathologic myopia: 0.5 mg into the affected eye as a single dose. Further injections may be given if monitoring reveals signs of disease activity (1-2 inj during the 1st yr; some patients may need more frequent treatment). Doses are given at intervals of at least 1 mth.
Diabetic macular oedema, Macular oedema secondary to retinal vein occlusion: 0.5 mg mthly into the affected eye as a single dose. Continue treatment until visual acuity is stable for 3 consecutive mth. Doses are given at intervals of at least 1 mth. Discontinue treatment if no improvement in visual acuity after 3 initial inj.
",,"May enhance the adverse/toxic effect of belimumab. Serious intraocular inflammation may occur when used adjunctively with verteporfin photodynamic therapy (PDT).
","Active or suspected ocular or periocular infection, active severe intraocular inflammation, signs of irreversible ischaemic visual function loss in patients with retinal vein occlusion.
","Ocular pain, hyperaemia, irritation and pruritus; increased intraocular pressure, vitritis, vitreous detachment, retinal haemorrhage, visual disturbance, vitreous floaters, conjunctival haemorrhage, foreign body sensation in eyes, increased lacrimation, blepharitis, dry eye, headache, nasopharyngitis, arthralgia, thromboembolic events. Less frequently, endophthalmitis, blindness, retinal detachment, retinal tear and iatrogenic traumatic cataract.
","Pregnancy Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Patient with risk factors for retinal pigment epithelial tears, history of stroke or transient ischaemic attack, uncontrolled HTN, previous intravitreal inj, active systemic infections, proliferative diabetic retinopathy, diabetic macular oedema due to type 1 DM. Discontinue treatment if rhegmatogenous retinal detachment or stage 3 or 4 macular hole develops. Diabetic patients w/ glycosylated Hb over 12%.
",,"Symptoms: Increased intraocular pressure, transient blindness, reduced visual acuity, corneal oedema, corneal pain, and eye pain.
Management: Intraocular pressure should be monitored and treated by the attending physician, if necessary.
",,,"Store between 2-8° C. Protect from light.
",11
+1901,Ramucirumab,ramucirumab-1901,https://medex.com.bd/attachments/PWVmp1WfcIQMvrmjbjOgovppeON2oS/ramucirumab-prescribing-information,Cytotoxic Chemotherapy,Non-small cell lung cancer,"Ramucirumab is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated:
+
+- As a single agent or in combination with paclitaxel, for treatment of advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
... Read more
Ramucirumab is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated:
+
+- As a single agent or in combination with paclitaxel, for treatment of advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
+- In combination with erlotinib, for first-line treatment of metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.
+- In combination with docetaxel, for treatment of metastatic non-small cell lung cancer with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Ramucirumab.
+- In combination with FOLFIRI, for the treatment of metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.
+- As a single agent, for the treatment of hepatocellular carcinoma in patients who have an alpha-fetoprotein of ≥400 ng/mL and have been treated with sorafenib.
+
","Cytotoxic Chemotherapy
","Ramucirumab is a VEGFR2 antagonist that specifically binds VEGFR2 and blocks binding of VEGFR ligands, VEGF-A, VEGF-C, and VEGF-D. As a result, ramucirumab inhibits ligand-stimulated activation of VEGFR2, thereby inhibiting ligand-induced proliferation, and migration of human endothelial cells. Ramucirumab inhibited angiogenesis in an in vivo animal model.
","For intravenous infusion only. Do not administer as an intravenous push or bolus. Premedicate before each infusion.
+
+- Gastric Cancer: Administer Ramucirumab 8 mg/kg every 2 weeks as a single agent or in combination with weekly paclitaxel.
+- Non-Small Cell Lung Cancer: Administer Ramucirumab 10 mg/kg every 2 weeks with daily erlotinib. Administer Ramucirumab 10 mg/kg on Day 1 of a 21-day cycle prior to docetaxel.
+- Colorectal Cancer: Administer Ramucirumab 8 mg/kg every 2 weeks prior to FOLFIRI.
+- Hepatocellular Carcinoma: Administer Ramucirumab 8 mg/kg every 2 weeks.
+
",,,,"The most common adverse reactions observed in single agent Ramucirumab-treated gastric cancer patients at a rate of ≥10% and ≥2% higher than placebo were hypertension and diarrhea.
The most common adverse reactions observed in patients treated with Ramucirumab with paclitaxel at a rate of ≥30% and ≥2% higher than placebo with paclitaxel were fatigue/asthenia, neutropenia, diarrhea, and epistaxis.
The most common adverse reactions observed in patients treated with Ramucirumab with erlotinib at a rate of ≥30% and ≥2% higher than placebo with erlotinib were, infections, hypertension, stomatitis, proteinuria, alopecia, and epistaxis. The most common laboratory abnormalities at a rate of ≥30% and ≥2% higher difference in incidence between arms were increased alanine aminotransferase, increased aspartate aminotransferase, anemia, thrombocytopenia, and neutropenia.
The most common adverse reactions observed in patients treated with Ramucirumab with docetaxel at a rate of ≥30% and ≥2% higher than placebo with docetaxel were neutropenia, fatigue/asthenia, and stomatitis/mucosal inflammation.
The most common adverse reactions observed in patients treated with Ramucirumab with FOLFIRI at a rate of ≥30% and ≥2% higher than placebo with FOLFIRI were diarrhea, neutropenia, decreased appetite, epistaxis, and stomatitis.
The most common adverse reactions observed in single agent Ramucirumab-treated HCC patients at a rate of ≥15% and ≥2% higher than placebo were fatigue, peripheral edema, hypertension, abdominal pain, decreased appetite, proteinuria, nausea, and ascites. The most common laboratory abnormalities at a rate of ≥30% and a ≥2% higher difference in incidence between arms were thrombocytopenia, hypoalbuminemia, and hyponatremia.
","Based on its mechanism of action, Ramucirumab can cause fetal harm when administered to a pregnant woman. There are no available data on Ramucirumab use in pregnant women. Animal models link angiogenesis, VEGF and VEGFR2 to critical aspects of female reproduction, embryo-fetal development, and postnatal development. No animal studies have been conducted to evaluate the effect of ramucirumab on reproduction and fetal development. Advise a pregnant woman of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
There is no information on the presence of ramucirumab in human milk or its effects on the breastfed child or on milk production. Human IgG is present in human milk, but published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. Because of the potential risk for serious adverse reactions in breastfed children from ramucirumab, advise women not to breastfeed during treatment with Ramucirumab and for 2 months after the last dose.
","Hemorrhage: Ramucirumab increases the risk of hemorrhage and gastrointestinal hemorrhage, including severe and fatal events. Permanently discontinue Ramucirumab in patients who experience severe bleeding.
Gastrointestinal Perforations: Ramucirumab increases the risk of gastrointestinal perforation, which can be fatal. Permanently discontinue Ramucirumab in patients who experience a gastrointestinal perforation.
Impaired Wound Healing: Withhold Ramucirumab for 28 days prior to elective surgery. Do not administer Ramucirumab for at least 2 weeks following a major surgical procedure and until adequate wound healing. The safety of resumption of Ramucirumab after resolution of wound healing complications has not been established.
Arterial Thromboembolic Events (ATEs): Serious and sometimes fatal ATEs can occur with Ramucirumab. Permanently discontinue Ramucirumab in patients who experience an ATE.
Hypertension: Monitor blood pressure and treat hypertension. Withhold Ramucirumab for severe hypertension. Permanently discontinue Ramucirumab for hypertension that cannot be controlled with antihypertensive therapy and for hypertensive crisis or hypertensive encephalopathy.
Infusion-Related Reactions (IRR): Monitor for signs and symptoms during infusion. Reduce the infusion rate for Grade 1 or 2 IRR and permanently discontinue for Grade 3 or 4 IRR.
Worsening of Pre-existing Hepatic Impairment: New onset or worsening encephalopathy, ascites or hepatorenal syndrome can occur in patients with Child-Pugh B or C cirrhosis.
Posterior Reversible Encephalopathy Syndrome: Permanently discontinue Ramucirumab.
Proteinuria Including Nephrotic Syndrome: Monitor for proteinuria. Withhold Ramucirumab for urine protein levels greater than or equal to 2 g per 24 hours. Permanently discontinue Ramucirumab for urine protein levels greater than 3 g per 24 hours or nephrotic syndrome.
Thyroid Dysfunction: Monitor thyroid function during treatment.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
",,,,,"Store vials in a refrigerator at 2°C to 8°C in the original carton to protect from light until time of use. Do not freeze or shake the vial.
",8
+571,Ramipril + Hydrochlorothiazide,ramipril-hydrochlorothiazide-571,https://medex.com.bd/attachments/MHigfLjeHXrsobIkyhKUttHT2WfrN2/ramipril-hydrochlorothiazide-prescribing-information,Combined antihypertensive preparations,Hypertension,"Indicated for the treatment of mild to moderate hypertension in patients (in whom combination therapy is appropriate) who have been stabilised on the individual components given in the same proportion.
","Combined antihypertensive preparations
","Ramipril is an angiotensin converting enzyme (ACE) inhibitor, which after hydrolysis to ramiprilat, blocks the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. So, inhibition of ACE by ramipril results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and decreased aldosterone secretion. Thus ramipril exerts its antihypertensive activity. It is also effective in the management of heart failure and reduction of the risk of stroke, myocardial infarction and death from cardiovascular events. It is long acting and well tolerated; so, can be used in long term therapy.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so co-administration of anangiotensin converting enzyme (ACE) inhibitor tends to reverse the potassium loss associated with these diuretics.
","Dose Titration Guided by Clinical Effect. A patient whose blood pressure is not adequately controlled with ramipril (or another ACE inhibitor) alone or with hydrochlorothiazide (or another thiazide diuretic) alone may be switched to combination therapy with Ramipril 2.5 mg + Hydrochlorothiazide 12.5 mg or Ramipril 5 mg + Hydrochlorothiazide 25 mg tablet.
Replacement Therapy: For convenience, patients receiving ramipril and hydrochlorothiazide from separate tablets may instead wish to receive tablets of combination of Ramipril 2.5 mg + Hydrochlorothiazide 12.5 mg or Ramipril 5 mg + Hydrochlorothiazide 25 mg. If necessary, the dose may be increased to two tablets of Ramipril 2.5 mg + Hydrochlorothiazide 12.5 mg or Ramipril 5 mg + Hydrochlorothiazide 25 mg once daily.
Maximum daily dose: 10 mg ramipril and 50 mg hydrochlorothiazide (four tablets of Ramipril 2.5 mg + Hydrochlorothiazide 12.5 mg or two tablets of Ramipril 5 mg + Hydrochlorothiazide 25 mg).
",,"Combination with diuretics or other antihypertensive agents or nitrates and tricyclic antidepressants may potentiate the antihypertensive response to Ramipril and Hydrochlorothiazide combination. Patients previously treated with diuretics may experience a marked drop in blood pressure. Ramipril / Hydrochlorothiazide may weaken the effectiveness of blood sugar lowering medications (antidiabetic agents, e.g. insulin and sulphonylurea derivatives). When Ramipril/Hydrochlorothiazide is administered simultaneously with acetyl salicylic acid or indomethacin, attenuation of antihypertensive effect and moreover acute renal failure may occur. Ramipril / Hydrochlorothiazide may potentiate the effects of alcohol.
","This preparation must not be used in patients with hypersensitivity to ramipril, hydrochlorothiazide or other thiazide diuretics. History of hereditary angioneurotic oedema. Severe impairment of renal function. Haemodynamically relevant unilateral or bilateral renal artery stenosis, mitral stenosis, aortic stenosis, and in patients with low blood pressure (hypotensive patients) or in patients with an unstable circulatory situation (haemodynamically unstable patients) where there might be a risk of life-threatening fall in blood pressure and renal failure. Clinically relevant electrolyte disturbances e.g. hypokalemia, hyponatremia or hypercalcemia which may worsen following treatment.
","The combination of Ramipril and Hydrochlorothiazide is generally well tolerated. Side effects commonly reported include headache, dizziness, asthenia, nausea, vomiting, hypotension, cough, weakness, diarrhoea, fever, gastric irritation, pulmonary oedema, photosensitivity, electrolyte imbalance, hyperglycaemia, hyperuricaemia and vertigo.
","ACE inhibitors can cause foetal and neonatal morbidity and death when administered to pregnant women. Also, thiazides cross the placental barrier and appear in cord blood. There is a risk of foetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults. When pregnancy is detected, Ramipril and Hydrochlorothiazide combination should be discontinued as soon as possible. This product is excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants, women receiving Ramipril and Hydrochlorothiazide combination should not breast feed.
","Treatment with Ramipril and Hydrochlorothiazide combination requires regular medical supervision. Generally dehydration, reduced blood volume (hypovolumia) or salt depletion should be corrected before initiating the treatment (in patients with concomitant heart failure, however, this must be carefully weighed against the risk of volume overload).
Special caution is necessary during the treatment of: Patients with severe and particularly with malignant hypertension. Patients with concomitant and particularly with severe heart failure. Patients in whom fluid or salt deficiency exists or may develop (as a result of inadequate fluid or salt intake) or as a result of diarrhoea, vomiting or excessive sweating in cases where salt and fluid replacement is inadequate. Patients with haemodynamically relevant renal artery stenosis. In patients with pre-existing impairment of renal function or in kidney transplant patients. White blood cell count should be monitored (more frequent in the initial phase of the treatment) so that leucopenia can be detected. Insufficient experience has been gained concerning the use of Ramipril and Hydrochlorothiazide combination in children.
","Dosage in renal impairment: In patients with a creatinine clearance between 60 and 30 ml/min, treatment should be initiated with Ramipril 1.25 mg monotherapy. If blood pressure is not adequately controlled, the dose of Ramipril may be increased to 2.5 mg. If blood pressure is still not controlled, patient may be switched to one tablet of Ramoril 2.5 Plus once daily. Dosage may be titrated upward to Ramoril 5 Plus until blood pressure is controlled.
Uue in children: Safety and effectiveness in paediatric patients have not been established
","Ramipril: Limited data on human overdosage are available. The most likely clinical manifestations would be symptoms attributable to hypotension. Because the hypotensive effect of Ramipril is achieved through vasodilation and effective hypovolemia, it is reasonable to treat Ramipril overdosage by infusion of normal saline solution.
Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia, may accentuate cardiac arrhythmias. The degree to which Hydrochlorothiazide is removed by hemodialysis has not been established.
",,,"Store in a cool and dry place, protected from light.
",12
+947,Ramipril,ramipril-947,https://medex.com.bd/attachments/BnMhXyUgdF8bFkwoj4z3JM7JdzIIFC/ramipril-capsule-prescribing-information,Angiotensin-converting enzyme (ACE) inhibitors,Thrombotic cardiovascular (CV) events,"Ramipril indicated in the following cases:
+
+- Hypertension; to lower blood pressure, as single-drug therapy or in combination with other antihypertensive agents.
+- Congestive heart failure; also in combination with diuretics.
+- Treatment of patients who- within the first few days after an acute myocardial infarction- have demonstrated clinical signs of congestive heart failure.
... Read more
Ramipril indicated in the following cases:
+
+- Hypertension; to lower blood pressure, as single-drug therapy or in combination with other antihypertensive agents.
+- Congestive heart failure; also in combination with diuretics.
+- Treatment of patients who- within the first few days after an acute myocardial infarction- have demonstrated clinical signs of congestive heart failure.
+- Treatment of non-diabetic or diabetic overt glomerular or incipient nephropathy.
+- Reduction in the risk of myocardial infarction, stroke, or cardiovascular death in patients with an increased cardiovascular risk, such as manifest coronary heart disease (with or without a history of myocardial infarction), a history of stroke, a history of peripheral vascular disease, or diabetes mellitus that is accompanied by at least one other cardiovascular risk factor (microalbuminuria, hypertension, elevated total cholesterol levels, low high-density lipoprotein cholesterol levels, smoking).
+
","Angiotensin-converting enzyme (ACE) inhibitors
","Ramipril is an angiotensin converting enzyme (ACE) inhibitor, which after hydrolysis to ramiprilat, blocks the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. So, inhibition of ACE by ramipril results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and decreased aldosterone secretion. Thus ramipril exerts its antihypertensive activity. It is also effective in the management of heart failure and reduction of the risk of stroke, myocardial infarction and death from cardiovascular events. It is long acting and well tolerated; so, can be used in long term therapy.
","Dosage of Ramipril must be adjusted according to the patient tolerance and response.
Hypertension: For the management of hypertension in adults not receiving a diuretic, the usual initial dose of Ramipril is 1.25-2.5 mg once daily. Dosage generally is adjusted no more rapidly than at 2 week intervals. The usual maintenance dosage in adults is 2.5-20 mg daily given as a single dose or in 2 divided doses daily. If BP is not controlled with Ramipril alone, a diuretic may be added.
Congestive heart failure after myocardial infarction: In this case, Ramipril therapy may be initiated as early as 2 days after myocardial infarction. An initial dose of 2.5 mg twice daily is recommended, but if hypotension occurs, dose should be reduced to 1.25 mg twice daily. Therapy is then titrated to a target daily dose of 5 mg twice daily.
Prevention of major cardiovascular events: In this case, the recommended dose is 2.5 mg once daily for the first week of therapy and 5 mg once daily for the following 3 weeks; dosage then may be increased, as tolerated, to a maintenance dosage of 10 mg once daily.
Dosage in renal impairment:
+
+- For patients with hypertension and renal impairment: The recommended initial dose is 1.25 mg Ramipril once daily. Subsequent dosage should be titrated according to individual tolerance and BP response, up to a maximum of 5 mg daily.
+- For patients with heart failure and renal impairment: The recommended dose is 1.25 mg once daily. The dose may be increased to 1.25 mg twice daily and up to a maximum dose of 2.5 mg twice daily depending upon clinical response and tolerability.
+
","Ramipril tablets have to be swallowed with sufficient amounts of liquid. The tablets must not be chewed or crushed. Absorption of Ramipril is not significantly affected by food. Ramipril may, therefore, be taken before, during or after a meal.
","Concomitant administration with diuretics may lead to serious hypotension and in addition dangerous hyperkalemia with potassium sparing diuretics. Concomitant therapy with lithium may increase the serum lithium concentration. Reduction in BP may affect the ability to drive and operate machinery and this may be exacerbated by alcohol. NSAIDs may reduce the antihypertensive effect of Ramipril and cause deterioration of renal function.
","Ramipril must not be used
+
+- in patients with hypersensitivity to ramipril, to any other ACE inhibitor, or any of the excipients of Ramipril.
+- in patients with a history of angioedema.
+- concomitantly with sacubitril/valsartan therapy. Do not initiate Ramipril until sacubitril/valsartan is eliminated from the body. In case of switch from Ramipril to sacubitril/valsartan, do not start sacubitril/valsartan until Ramipril is eliminated from the body.
+- in patients with haemodynamically relevant renal artery stenosis, bilateral or unilateral in the single kidney.
+- in patients with hypotensive or haemodynamically unstable states.
+- with aliskiren-containing medicines in patients with diabetes or with moderate to severe renal impairment (creatinine clearance <60 ml/min).
+- with angiotensin II receptor antagonists (AIIRAs) in patients with diabetic nephropathy.
+- during pregnancy.
+
+Concomitant use of ACE inhibitors and extracorporeal treatments leading to contact of blood with negatively charged surfaces must be avoided, since such use may lead to severe anaphylactoid reactions. Such extracorporeal treatments include dialysis or haemofiltration with certain high-fux (e.g. polyacrylonitril) membranes and low-density lipoprotein apheresis with dextran sulfate.
","Ramipril is generally well tolerated. Dizziness, headache, fatigue and asthenia are commonly reported side effects. Other side effects occurring less frequently include symptomatic hypotension, cough, nausea, vomiting, diarrhoea, rash, urticaria, oliguria, anxiety, amnesia etc. Angioneurotic oedema, anaphylactic reactions and hyperkalaemia have also been reported rarely.
","Ramipril must not be taken during pregnancy. Therefore, pregnancy must be excluded before starting treatment. Pregnancy must be avoided in cases where treatment with ACE inhibitors is indispensable. If the patient intends to become pregnant, treatment with ACE inhibitors must be discontinued, i.e. replaced by another form of treatment. If the patient becomes pregnant during treatment, medication with Ramipril must be replaced as soon as possible by a treatment regimen without ACE inhibitors. Otherwise, there is a risk of harm to the fetus. Ramipril is not recommended during breastfeeding.
","Ramipril should be used with caution in patients with impaired renal function, hyperkalaemia, hypotension, and impaired hepatic function.
","Elderly: A reduced initial dose of 1.25 mg Ramipril daily must be considered.
Hepatic impairment: Treatment in these patients must therefore be initiated only under close medical supervision. The maximum permitted daily dose in such cases is 2.5 mg Ramipril.
Renal impairment: With a creatinine clearance between 50 and 20 ml/min per 1.73 m2 body surface area, the initial daily dose is generally 1.25 mg Ramipril. The maximum permitted daily dose, in this case, is 5 mg Ramipril. Patients with incompletely corrected fuid or salt depletion, in patients with severe hypertension, as well as in patients in whom a hypotensive reaction would constitute a particular risk, (e.g., with relevant stenoses of the coronary vessels or those supplying the brain) A reduced initial dose of 1.25 mg Ramipril daily must be considered.
Patients pretreated with a diuretic: Consideration must be given to discontinuing the diuretic for at least 2 to 3 days or- depending on the duration of action of the diuretic- longer before starting treatment with Ramipril, or at least to reducing the diuretic dose. The initial daily dose in patients previously treated with a diuretic is generally 1.25 mg Ramipril.
","Sign and symptom: Overdosage may cause excessive peripheral vasodilatation (with marked hypotension, shock), bradycardia, electrolyte disturbances, and renal failure.
Management: Primary detoxifcation by, for example, gastric lavage, administration of adsorbents, sodium sulfate; (if possible during the frst 30 minutes). In the event of hypotension administration of α1-adrenergic agonists (e.g. norepinephrine, dopamine) or angiotensin II (angiotensinamide), which is usually available only in scattered research laboratories, must be considered in addition to volume and salt substitution.
",,,"Store at 30° or below, protect from light. Keep out of the reach of children. Do not use later than the date of expiry. To be dispensed only on the prescription of a registered physician.
",13
+1408,Ramelteon,ramelteon-1408,https://medex.com.bd/attachments/rHxMjCZpqKnCl7wmWuRTEUM2mfaAqb/ramelteon-prescribing-information,Miscellaneous sedatives & hypnotics,Insomnia and sleep disturbances,"Ramelteoni s indicated for the treatment of insomnia characterized by difficulty with sleep onset
","Miscellaneous sedatives & hypnotics
","Ramelteon is a melatonin receptor agonist with both high affinity for melatonin MT1 and MT2receptors, and lower selectivity for the MT3 receptor. Melatonin production is concurrent with nocturnal sleep, meaning that an increase in melatonin levels is related to the onset of self-reported sleepiness and an increase in sleep propensity. MT1 receptors are believed to be responsible for regulation of sleepiness and facilitation of sleep onset, and MT2 receptors are believed to mediate phase-shifting effects of melatonin on the circadian rhythm. While MT1 and MT2 receptors are associated with the sleep-wake cycle, MT3 has a completely different profile, and therefore is not likely to be involved in the sleep-wake cycle. Remelteon has no appreciable affinity for the gamma-aminobutyric acid (GABA) receptor complex or receptors that bind neuropeptides, cytokines, serotonin, dopamine, norepinephrine, acetylcholine, or opiates.
","Adult dose: 8 mg taken within 30 minutes of going to bed. Should not be taken with or immediately after a high-fat meal. The total daily dose should not exceed 8 mg.
",,"Rifampin (strong CYP enzyme inducer): Decreases exposure to and effects of ramelteon.
Ketoconazole (strong CYP3A4 inhibitor): Increases AUC for ramelteon; administer with caution.
Fluconazole (strong CYP2C9 inhibitor): Increases systemic exposure of ramelteon; administer with caution. Donepezil increases systemic exposure of ramelteon; patients should be closely monitored when ramelteon is co administered with donepezil. Doxepin increases systemic exposure of ramelteon; patients should be closely monitored when ramelteon is co administered with doxepin.
Alcohol: Causes additive psychomotor impairment; should not be used in combination
","
+- History of angioedema while taking Ramelteon.
+- Fluvoxamine (strong CYP1A2 inhibitor): Increases AUC for ramelteon and should not be used in combination
+
","Most common adverse reactions (≥3% and more common than with placebo) are: somnolence, dizziness, fatigue, nausea, and exacerbated insomnia
","Pregnancy: Based on animal data may cause fetal harm. Do not use unless the potential benefit justifies the potential risk.
Nursing mothers: Use with caution.
","Severe anaphylactic/anaphylactoid reactions: Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur.
Need to evaluate for co-morbid diagnoses: Reevaluate if insomnia persists after 7 to 10 days of treatment.
Abnormal thinking, behavioral changes, complex behaviors: May include ""sleep-driving"" and hallucinations. Immediately evaluate any new onset behavioral changes.
Depression: Worsening of depression or suicidal thinking may occur.
CNS effects: Potential impairment of activities requiring complete mental alertness such as operating machinery or driving a motor vehicle, after ingesting the drug.
Reproductive effects: Include decreased testosterone and increased prolactin levels. Effect on the reproductive axis in developing humans is unknown
Patients with severe sleep apnea: Rozerem is not recommended for use in this population.
","Pediatric use: Safety and effectiveness not established.
Geriatric use: No overall differences in safety and efficacy between elderly and younger adult subjects.
Hepatic impairment: Is not recommended in patients with severe impairment; use with caution in moderate impairment.
",,,,"Store at 25°C; excursions permitted to 15° to 30°C. Keep container tightly closed and protected from moisture and humidity.
",11
+1814,Racepinephrine,racepinephrine-1814,https://medex.com.bd/attachments/OjGrlYchzli7IYzeFQpsJEWcJSp2IV/racepinephrine-prescribing-information,Other adrenoceptor stimulants,Wheezing,"For temporary relief of mild symptoms of intermittent asthma: Wheezing, tightness of chest and shortness of breath.
","Other adrenoceptor stimulants
","Racepinephrine is an alpha- and beta-adrenoreceptor stimulant. Racepinephrine works by widening the airways, reducing spasms of bronchial muscles of asthma patients, which makes it easier to breathe.
","Adults and children 4 years of age and over-
+
+- Jet Nebulizer: Nebulisation for fifteen minutes every 3 to 4 hours. One 0.5 ml ampoule should be diluted to a volume of 3 to 5 ml with sterile 0.9% sodium chloride solution.
+- Hand-held Bulb Nebulizer: 1 to 3 inhalations not more often than every 3 hours. The racepinephrine inhalation solution does not require dilution. Should not use more than 12 inhalations in 24 hours.
+
+Children under 4 years of age: Use according to the physician's direction.
",,"Concurrent use with other adrenergic agents will have additive adrenergic side effects. Use with MAO inhibitors may lead to hypertensive crisis. Beta-blockers may negate the therapeutic effect. Tricyclic antidepressants enhance response to epinephrine.
",,"Side effects of Racepinephrine includes headache, loss of appetite, nausea & vomiting, nervousness, tremors, trouble sleeping, fear, agitation, anxiety, restlessness, dizziness, impaired memory, hallucinations, and psychosis. Severe allergic reactions (rash, hives, itching, and difficulty in breathing, swelling of the mouth, face, lips, or tongue), chest pain, fast heartbeat and wheezing may occur. Besides, elevations of heart rate and blood pressure or arrhythmias may occur. Cardiac patients with coronary artery disease or hypertension may worsen condition.
","Racemic epinephrine is a 1:1 mixture of the Dextrorotatory and Levorotatory isomers of epinephrine. Epinephrine has been assigned to pregnancy category C by the US FDA. Epinephrine is only recommended for use during pregnancy when there are no alternatives and benefit outweighs the risk. Epinephrine is excreted into human milk. Due to the potential for serious adverse effects in nursing infants, a decision should be made to discontinue nursing or discontinue the drug.
","Racepinephrine should be used cautiously in patients with: cardiac disease (angina, tachycardia, myocardial infarction, hypertension), hyperthyroidism, diabetes, cerebral arteriosclerosis. Excessive use may lead to tolerance and paradoxical bronchospasm. Besides, it is advised not to use Racepinephrine if symptoms are not relieved within 20 minutes or become worse. Racepinephrine solution should not be used if it is brown in color or cloudy, pinkish or if it contains a precipitate.
",,"Excessive use may cause nervousness and rapid heartbeat, adverse effects on the heart. In case of overdose, the patient should get medical help right away.
",,,"Store at 2° to 8°C. Keep away from light and out of the reach of children.
",10
+945,Racecadotril,racecadotril-945,https://medex.com.bd/attachments/2aCkGKdJ0nvHlnXIK23hSyNg8fhlQf/racecadotril-prescribing-information,Anti-diarrhoeal,Diarrhoea,"Racecadotril is indicated for the symptomatic treatment of acute diarrhea.
","Anti-diarrhoeal
","Racecadotril increases the availability of endogenous opioids (enkephalins) by inhibiting the membrane-bound enkephalinase. The enkephalins in turn mediate their effect through δ receptor ( delta opioid receptor) activation that induces a selective increase in Cl absorption by inhibiting adenylate cyclase.
Onset: 30 min (plasma enkephalinase inhibition).
","Adults: One capsule initially, regardless of the time of day. Then one capsule three times daily preferably before the main meals.
Children (from 3 months of age): Racecadotril granules should be administered together with oral rehydration. The recommended dose is determined according to body weight: 1.5 mg/kg per administration, three times daily.
+
+- Infants less than 9 kg: one 10 mg sachet 3 times daily.
+- Infants from 9 kg to 13 kg: two 10 mg sachets 3 times daily.
+- Children from 13 kg to 27 kg: one 30mg sachet 3 times daily.
+- Children of more than 27 kg: two 30mg sachets 3 times daily.
+
",,"No drug interactions found. Joint treatment with Racecadotril and Loperamide or Nifuroxazide does not modify the kinetics of Racecadotril.
","Hypersensitivity to Racecadotril, or to any of the excipients.
","Headache, erythema multiforme, urticaria, angioedema may be seen.
","Due to a lack of clinical data, Racecadotril should not be administered to pregnant or breastfeeding women.
","The administration of Racecadotril does not modify the usual rehydration regimens. The presence of bloody stools and fever may indicate the presence of invasive bacteria as a reason for diarrhea or the presence of other severe disease. Racecadotril has not been tested in antibiotic-associated diarrhea and should therefore not be administered under these conditions. Caution should be taken in patients with renal or liver impairment.
",,"No cases of overdose have been reported. In adults, single doses above 2 g which is equivalent to 20 times the therapeutic dose, have been administered, and no harmful effects have been described.
",,,,10
+944,Rabies Vaccine,rabies-vaccine-944,https://medex.com.bd/attachments/jdXBjOrGgsCdok78bioVreeK0e2OnQ/rabies-vaccine-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Active immunisation against rabies,"Rabies vaccine is indicated for prophylactic immunization against rabies and treatment of patients following suspected rabies contact.
Pre-exposure Immunization:
+
+- Professional groups exposed to frequent contamination
+- Veterinary surgeons (including students at veterinary colleges)
... Read more
Rabies vaccine is indicated for prophylactic immunization against rabies and treatment of patients following suspected rabies contact.
Pre-exposure Immunization:
+
+- Professional groups exposed to frequent contamination
+- Veterinary surgeons (including students at veterinary colleges)
+- Technical personnel working with veterinary surgeons
+- Laboratory personnel handling material contaminated with rabies vims
+- Personnel in abattoirs and knackers yards
+- Taxidermists
+- Gamekeepers, forestry workers and naturalists in enzootic areas
+- Infants particularly exposed to the risk of rabies
+
+Post-exposure Immunization:
+
+- Treatment of subjects bitten by rabid animals or those suspected of being so
+- Treatment of contact subjects.
+
","Vaccines, Anti-sera & Immunoglobulin
","Rabies Vaccine for human use is a freeze-dried preparations of inactivated rabies virus produced on Vero cell. After reconstitution the vaccine is a clear, colorless sterile solution for intramuscular use.
","To reconstitute the vaccine, transfer content of supplied diluent into the vial containing freeze-dried preparation. Do not shake. After reconstitution the solution should be homogeneous, clear and free from any particles. Vaccine must be injected immediately after reconstitution and the syringe should be destroyed after use.
Method of administration for intramuscular use: The 1 ml dose of Rabies vaccine should be given intramuscularly in the deltoid in adults and in the anterolateral aspect of the thigh muscle in children under 1 year. It should not be injected into the gluteal region. Do not inject intravenously.
Pre-exposure immunization:
+
+- 1 ml for children and adults.
+- Primary-vaccination: According to the WHO recommendations 1 injection by the intramuscular route on days DO, D7, D21 or D28, followed by a booster dose one year later.
+- Boosters: Thereafter, one injection every 5 years or when the titre is found to be less than 0.5 lU/ml
+
+
Post-exposure immunization:
+
+- Local treatment of the wound: Prompt and gentle through washing with soap or detergent and flushing the wound with running tap water for at least 15 minutes. After washing, disinfectants like either ethanol (700 ml/l) or tincture or aqueous solution of iodine or povidone iodine must be applied. Don't bandage or suture the wound.
+- Vaccination of non-immunized subjects
+
+Intramuscular schedules: One Intramuscular (IM) dose comprised of 1 ml.
Standard intramuscular (1-1-1-1-1) regimen:
+
+- Day 0: 1 injection of 1 ml
+- Day 3: 1 injection of 1 ml
+- Day 7: 1 injection of 1 ml
+- Day 14: 1 injection of 1 ml
+- Day 28: 1 injection of 1 ml
+
+Or abbreviated multisite (2-1-1) regimen:
+
+- Day 0: 2 injections each of 1 ml at separate sites
+- Day 7: 1 injection of 1 ml
+- Day 21: 1 injection of 1 ml
+
+In case of severe (WHO category 3) wounds, rabies immunoglobulin should be administered as soon as possible with the first dose of rabies vaccine. The anti-rabies immunoglobulin should be used as local wound soakage injections as much as possible, with the rest part for muscle injection. The rabies vaccine should be administered in different injection site.
Vaccination of subjects already immunized: Patients had complete post exposure immunization schedule within 1 year. Bitten by suspected rabid animal, 1 dose injection is required on Day 0, Day 3, respectively. Patients had complete post-exposure immunization schedule 1 year ago, Bitten by suspected rabid animal, complete post-exposure immunization required. Patient had complete immunization schedule and booster immunization within 3 years. Bitten by suspected rabid animal, 1 dose injection is required on Day 0, Day 3, respectively. Patient had complete immunization schedule and booster immunization 3 years ago. Bitten by suspected rabid animal, complete post-exposure immunization required. Post-exposure vaccination must be administered on the basis of severity under medical supervision.
","Co-administration: Corticosteroid and immunosuppressive treatment may interfere with antibody production and cause vaccination failure. In these cases, a titration of neutralizing antibodies should be performed.
","Concurrent use with immunosuppressants may reduce the efficacy of vaccines.
","Rabies vaccine is contraindicated in the following cases:
Pre-exposure: Severe fever, febrile infection, acute disease, progressive chronic diseases. Known hypersensitivity reactions to rabies vaccine or any of its components
Post-exposure: No contraindication to post-exposure treatment, because rabies is lethal disease, any contraindication to exposure, treatment should be considered carefully before disqualifying an individual for anti-rabies treatment.
","Minor local reactions like pain, erythema, oedema, pruritus and induration at the injection site and lasting to 24-48 hours. Moderate fever, shivering, fainting, asthenia, dizziness, respiratory manifestations (dyspnoea, wheezing), fever, abdominal pain, vomiting and allergic skin reactions (urticaria, rash, itching).
","Pregnancy. The potential risk of administration of rabies vaccine during pregnancy is unknown. Due to the severity of the disease, pregnancy is not considered to be a contraindication to post-exposure prophylaxis.
Lactation: It is not known whether the vaccine is excreted in human breast milk. Due to the severity of the disease, breast-feeding is not considered a contraindication.
","
+- Intravenous injection is prohibited.
+- The vaccine and anti-rabies immunoglobulin must not be administered with same syringe and in the same injection site.
+- Before use, please carefully check package, label, appearance and the validity period.
+- After reconstitution, the freeze-dried rabies vaccine should be administered as soon as possible.
+- Any reconstituted vaccine should be used as soon as possible. It must be stored in a refrigerator at 2°C to 8°C and used within 8 hours after reconstitution or discarded.
+
",,,,,"Keep out of the reach and sight of children. Store & transport at 2°C to 8°C. Protect from light. Do not keep in the deep freeze.
",11
+968,Roflumilast,roflumilast-968,https://medex.com.bd/attachments/p1eAf6ex5JabqDVkRHV4VirfJMh76P/roflumilast-prescribing-information,Antihistamines anti-allergies & hypo-sensitisation,COPD,"Roflumilast is indicated:
+
+- As add-on therapy to bronchodilator treatment.
+- For the maintenance treatment of severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis (i.e. patients with a history of chronic cough and sputum) in adult patients with a history of frequent exacerbations.
+
+Roflumilast should not be used as a rescue medication.
","Antihistamines anti-allergies & hypo-sensitisation
","Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor which, due to its selective inhibition of the PDE4 isoenzyme, has potential antiinflammatory and antimodulatory effects in the pulmonary system. It is thought that the increased levels of intracellular cyclic AMP are responsible for the therapeutic actions of Roflumilast.
","The recommended dosage for patients with COPD is one 500 mcg tablet daily, with or without food.
",,"A major step in Roflumilast metabolism is the N-oxidation of Roflumilast to Roflumilast N-oxide by CYP3A4 and CYP1A2. Therefore, the use of strong cytochrome P450 enzyme inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin) with Roflumilast is not recommended. The co-administration of Roflumilast with CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) may increase Roflumilast systemic exposure and may result in increased adverse reactions. The co-administration of Roflumilast with oral contraceptives containing gestodene and ethinyl estradiol may increase roflumilast systemic exposure and may result in increased side effects.
","Hypersensitivity to Roflumilast or to any of the excipients. Moderate to severe liver impairment.
","General disorders: Fatigue.
Metabolism and nutrition disorders: Decreased appetite, Weight decreased.
Musculoskeletal and connective tissue disorders: Back pain, muscle spasms.
Nervous system disorders: Dizziness, Headache, Tremor.
Psychiatric disorders: Anxiety, Depression, Insomnia.
","Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Roflumilast should not be used during pregnancy & lactation.
","Not as emergency treatment for relief of acute brochospasm. Monitor body wt regularly. Severe immunological disease, severe acute infections, cancers (except basal cell carcinoma) or patients on immunosuppressants; CHF (NYHA grades III & IV). History of depression associated with suicidal ideation or behavior. Galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. Hepatic impairment. Pregnancy & lactation.
","Geriatrics ( 65 years of age): There were no overall differences in safety and effectiveness of Roflumilast in the elderly compared to younger patients with COPD. Therefore, no dose adjustment is necessary.
Pediatrics (<18 years of age): Safety and effectiveness of Roflumilast in children and adolescents below 18 years of age have not been established.
Hepatic Impairment: Roflumilast is not recommended for use in patients with moderate or severe liver impairment.
Renal impairment: No dosage adjustment is necessary for patients with renal impairment
","No case of overdose has been reported in clinical studies with Roflumilast. However, during the Phase I studies of Roflumilast, at an increased rate after a single oral dose of 2500 mcg and a single dose of 5000 mcg,
The following symptoms were observed: headache, gastrointestinal disorders, dizziness, palpitations, lightheadedness, clamminess and arterial hypotension.
Missed Dose: Patients should be advised that if they forget to take a tablet at the usual time, they should take the tablet as soon as they remember or continue on the next day with the next tablet at the usual time. Patients should not take a double dose to make up for a forgotten dose.
",,,"Store below 30° C, keep away from light, moisture. Keep out of the reach of children.
",12
+966,Rocuronium Bromide,rocuronium-bromide-966,https://medex.com.bd/attachments/7ZS1LLp7ykkC8UD2XpqtTpsiguRikq/rocuronium-bromide-prescribing-information,Non depolarizing muscle relaxants,Muscle relaxant in general anaesthesia,"Rocuronium is indicated -
+
+- As an adjunct to general anesthesia to facilitate tracheal intubation during routine induction, and during rapid sequence induction when suxamethonium is contraindicated
+- To provide skeletal muscle relaxation during surgery
+- As an adjunct in the intensive care unit (ICU) to facilitate intubation and mechanical ventilation
+
","Non depolarizing muscle relaxants
","Rocuronium acts by competing for cholinergic receptors at the motor end-plate. This action is antagonized by acetylcholinesterase inhibitors, such as neostigmine and edrophonium. Rocuronium acts by competitively binding to nicotinic cholinergic receptors. The binding of vecuronium decreases the opportunity for acetylcholine to bind to the nicotinic receptor at the postjunctional membrane of the myoneural junction. As a result, depolarization is prevented, calcium ions are not released and muscle contraction does not occur. Evidence also suggests that nondepolarizing agents can affect ACh release. It has been hypothesized that nondepolarzing agents bind to postjunctional (""curare"") receptors and may therefore interfere with the sodium and potassium flux, which is responsible for depolarization and repolarization of the membranes involved in muscle contraction.
","Dosage: Like other neuromuscular blocking agents, Rocuronium should only be administered by, or under supervision of, experienced clinicians who are familiar with the action and use of these agents. The dosage of Rocuronium should be individualized in each patient. The method of anesthesia and the expected duration of surgery, the method of sedation and the expected duration of mechanical ventilation, the possible interaction with other medicines that are administered concomitantly and the condition of the patient should be taken into account when determining the dose. The use of an appropriate neuromuscular monitoring technique is recommended for the evaluation of neuromuscular block and recovery. Inhalational anesthetics do potentiate the neuromuscular blocking effects of Rocuronium. This potentiation, however, becomes clinically relevant in the course of anesthesia, when the volatile agents have reached the tissue concentrations required for this interaction. Consequently, adjustments with Rocuronium should be made by administering smaller maintenance doses at less frequent intervals or by using lower infusion rates of Rocuronium during long lasting procedures (longer than 1 hour) under inhalational anesthesia. In adult patients the following dosage recommendations may serve as a general guideline for tracheal intubation and muscle relaxation for short to long lasting surgical procedures, and for use in the intensive care unit.
Surgical Procedures: Tracheal Intubation: The standard intubating dose during routine anesthesia is 0.6mg Rocuronium Bromide per kg body weight, after which adequate intubation conditions are established within 60 seconds in nearly all patients. A dose of 1.0mg Rocuronium Bromide per kg body weight is recommended for facilitating tracheal intubation conditions during rapid sequence induction of anesthesia, after which adequate intubation conditions are also established within 60 seconds in nearly all patients. If a dose of 0.6mg Rocuronium Bromide per kg body weight is used for rapid sequence induction of anesthesia, it is recommended to intubate the patient 90 seconds after administration of Rocuronium Bromide. In patients undergoing Caesarean section it is recommended to only use a dose of 0.6mg Rocuronium Bromide per kg body weight, since a 1.0mg/kg dose has not been investigated in this patient group.
Maintenance Dosing: The recommended maintenance dose is 0.15mg Rocuronium Bromide per kg body weight; in the case of long-term inhalational anesthesia this should be reduced to 0.075-0.1mg Rocuronium Bromide per kg body weight. The maintenance doses should best be given when twitch height has recovered to 25% of control twitch height, or when 2-3 responses to train of four stimulation are present.
Continuous Infusion: If Rocuronium Bromide is administered by continuous infusion, it is recommended to give a loading dose of 0.6mg Rocuronium Bromide per kg body weight and, when neuromuscular block starts to recover, to start administration by infusion. The infusion rate should be adjusted to maintain twitch response at 10% of control twitch height, or to maintain 1 to 2 responses to train of four stimulation. In adults under intravenous anesthesia, the infusion rate required to maintain neuromuscular block at this level ranges from 0.3-0.6mg/kg/hr and under inhalational anesthesia the infusion rate ranges from 0.3-0.4mg/kg/hr. Continuous monitoring of neuromuscular block is recommended since infusion rate requirements vary from patient to patient and with the anaesthetic method used.
Dosing in Paediatric Patients: Children (1-14 years) and infants (1-12 months) under halothane anesthesia manifest similar sensitivity to Rocuronium Bromide as adults. Onset of action is faster in infants and children than in adults. Clinical duration is shorter in children than in adults. For continuous infusion in paediatrics, the infusion rates, with exception of children, are the same as for adults. For children higher infusion rates might be necessary. For children the same initial infusion rates as for adults are recommended and this should be adjusted to maintain twitch response at 10% of control twitch height or to maintain 1 or 2 responses to train of four stimulation during the procedure. There are insufficient data to support dose recommendations for the use of Rocuronium Bromide in neonates (0-1 month). The experience with Rocuronium Bromide in rapid sequence induction in paediatric patients is limited. Rocuronium Bromide is therefore not recommended for facilitating tracheal intubation conditions during rapid sequence induction in paediatric patients.
Dosing in Geriatric patients and patients with Hepatic and/or Biliary tract disease and/or Renal Failure: The standard intubation dose for geriatric patients and patients with hepatic and/or biliary tract disease and/or renal failure during routine anesthesia is 0.6mg Rocuronium Bromide per kg body weight. A dose of 0.6mg per kg body weight should be considered for rapid sequence induction of anesthesia in patients in which a prolonged duration of action is expected. Regardless of the anesthetic technique used, the recommended maintenance dose for these patients is 0.075-0.1mg Rocuronium Bromide per kg body weight, and the recommended infusion rate is 0.3-0.4mg/kg/hr.
Dosing in Overweight and Obese Patients: When used in overweight or obese patients (defined as patients with a body weight of 30% or more above ideal body weight) doses should be reduced taking into account ideal body weight.
Intensive Care Procedures (Tracheal Intubation): For tracheal intubation, the same doses should be used as described above under surgical procedures.
Maintenance Dosing: The use of an initial loading dose of 0.6mg Rocuronium Bromide per kg body weight is recommended, followed by a continuous infusion as soon as twitch height recovers to 10% or upon reappearance of 1 to 2 twitches to train of four stimulation. Dosage should always be titrated to effect in the individual patient. The recommended initial infusion rate for the maintenance of a neuromuscular block of 80-90% (1 to 2 twitches to TOF stimulation) in adult patients is 0.3-0.6mg/kg/hr during the first hour of administration, which will need to be decreased during the following 6-12 hours, according to the individual response. Thereafter, individual dose requirements remain relatively constant. A large between patient variability in hourly infusion rates has been found in controlled clinical studies, with mean hourly infusion rates ranging from 0.2-0.5mg/kg/hr depending on nature and extent of organ failure(s), concomitant medication and individual patient characteristics. To provide optimal individual patient control, monitoring of neuromuscular transmission is strongly recommended. Administration up to 7 days has been investigated.
Special Populations: Rocuronium Bromide is not recommended for the facilitation of mechanical ventilation in the intensive care in paediatric and geriatric patients due to a lack of data on safety and efficacy.
",,"The following agents have been shown to influence the magnitude and/or duration of action of non-depolarizing neuromuscular blocking agents:
+
Effect of other agents on Rocuronium Bromide-
+
Increased Effect: Halogenated volatile anesthetics potentiate the neuromuscular block of Rocuronium Bromide. The effect only becomes apparent with maintenance dosing. Reversal of the block with anti-cholinesterase inhibitors could also be inhibited. Long-term concomitant use of corticosteroids and Rocuronium Bromide in the ICU may result in prolonged duration of neuromuscular block or myopathy.
Other drugs:
+
+- Antibiotics: aminoglycoside, lincosamide and polypeptide antibiotics, acylamino-penicillin antibiotics.
+- Diuretics, quinidine and its isomer quinine, magnesium salts, calcium channel blocking agents, lithium salts, local anaesthetics (lidocaine i.v., bupivacaine epidural) and acute administration of phenytoin
+- Recurarization has been reported after post-operative administration of: aminoglycoside, lincosamide, polypeptide and acylamino-penicillin antibiotics, quinidine, quinine and magnesium.
+
+
Decreased Effect: Prior chronic administration of phenytoin or carbamazepine. Protease inhibitors (gabexate, ulinastatin)
Variable Effect: Administration of other non-depolarizing neuromuscular blocking agents in combination with Rocuronium Bromide may produce attenuation or potentiation of the neuromuscular block, depending on the order of administration and the neuromuscular blocking agent used. Suxamethonium given after the administration of Rocuronium Bromide may produce potentiation or attenuation of the neuromuscular blocking effect of Rocuronium Bromide.
Effect of Rocuronium Bromide on other drugs: Rocuronium Bromide combined with lidocaine may result in a quicker onset of action of lidocaine.
","Hypersensitivity to Rocuronium or to the Bromide ion or to any of the excipients.
","In clinical trials, the most common adverse reactions (2%) are transient hypotension and hypertension. Other are:
+
+- Anaphylaxis
+- Residual paralysis
+- Myopathy
+- Increased pulmonary vascular resistance
+
+Although very rare, severe anaphylactic reactions to neuromuscular blocking agents, including Rocuronium Bromide, have been reported. Anaphylactic/anaphylactoid reactions are: bronchospasm, cardiovascular changes (e.g. hypotension, tachycardia, circulatory collapse - shock), and cutaneous changes (e.g. angioedema, urticaria). These reactions have, in some cases, been fatal. Due to the possible severity of these reactions, one should always assume they may occur and take the necessary precautions.
Since neuromuscular blocking agents are known to be capable of inducing histamine release both locally at the site of injection and systemically, the possible occurrence of itching and erythematosus reactions at the site of injection and/or generalized histaminoid (anaphylactoid) reactions (see also under Anaphylactic Reactions above) should always be taken into consideration when administering these agents. In clinical studies only a slight increase in mean plasma histamine levels has been observed following rapid bolus administration of 0.3 0.9mg/kg Rocuronium Bromide.
Prolonged neuromuscular block: The most frequent adverse reaction to nondepolarizing blocking agents as a class consists of an extension of the agent's pharmacological action beyond the time period needed. This may vary from skeletal muscle weakness to profound and prolonged skeletal muscle paralysis resulting in respiratory insufficiency or apnoea.
Myopathy: Myopathy has been reported after the use of various neuromuscular blocking agents in the ICU in combination with corticosteroids.
Local injection site reactions: During rapid sequence induction of anesthesia, pain on injection has been reported, especially when the patient has not yet completely lost consciousness and particularly when propofol is used as the induction agent. In clinical studies, pain on injection has been noted in 16% of the patients who underwent rapid sequence induction of anesthesia with propofol and in less than 0.5% of the patients who underwent rapid sequence induction of anesthesia with fentanyl and thiopental.
","Pregnancy: For Rocuronium Bromide, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Caution should be exercised when prescribing Rocuronium Bromide to pregnant women.
Caesarean section: In patients undergoing Caesarean section, Rocuronium Bromide can be used as part of a rapid sequence induction technique, provided no intubation difficulties are anticipated and a sufficient dose of anesthetic agent is administered or following suxamethonium facilitated intubation. Rocuronium Bromide, administered in doses of 0.6mg/kg, has been shown to be safe in parturient undergoing Caesarean section. Rocuronium Bromide does not affect Apgar score, foetal muscle tone nor cardio-respiratory adaptation. From umbilical cord blood sampling it is apparent that only limited placental transfer of Rocuronium Bromide occurs which does not lead to the observation of clinical adverse effects in the newborn.
Lactation: It is unknown whether Rocuronium Bromide is excreted in human breast milk. Animal studies have shown insignificant levels of Rocuronium Bromide in breast milk. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Rocuronium Bromide should be given to lactating women only when the attending physician decides that the benefits outweigh the risks.
","Instructions for use/handling: Compatibility studies with the following infusion fluids have been performed. In nominal concentrations of 0.5mg/mL and 2.0mg/mL, Rocuronium Bromide has been shown to be compatible with: 0.9% NaCl, 5% dextrose, 5% dextrose in saline, sterile water for injections, Lactated Ringers and Haemaccel. Administration should be commenced immediately after mixing, and should be completed within 24 hours. Unused solutions should be discarded.
For use/handling: If Rocuronium Bromide is administered via the same infusion line that is also used for other medicines, it is important that this infusion line is adequately flushed (e.g. with 0.9% NaCl) between administration of Rocuronium Bromide and medicines for which incompatibility with Rocuronium Bromide has been demonstrated or for which compatibility with Rocuronium Bromide has not been established.
",,"In the event of overdosage and prolonged neuromuscular block, the patient should continue to receive ventilatory support and sedation. In this situation there are two options for the reversal of neuromuscular block:
Sugammadex can be used for reversal of intense (profound) and deep block. The dose of sugammadex to be administered depends of the level of neuromuscular block.
An acetylcholinesterase inhibitor (e.g. neostigmine, edrophonium, pyridostigmine), with appropriate vagolytic (e.g atropine) can be used at reappearance of T2 or at the first signs of clinical recovery and should be administered in adequate doses. When administration of an acetylcholinesterase inhibiting agent fails to reverse the neuromuscular effects of Rocuronium Bromide, ventilation must be continued until spontaneous breathing is restored. Repeated dosage of an acetylcholinesterase inhibitor can be dangerous.
",,,"Rocuronium Bromide should be stored in the refrigerator at 2-8° C and not be frozen.
",11
+965,Rizatriptan Benzoate,rizatriptan-benzoate-965,https://medex.com.bd/attachments/jJrtvRIEMFqoLVsoc96tezNaqudinB/rizatriptan-benzoate-prescribing-information,5-HT Agonists,Cluster headache,"Rizatriptan Benzoate is indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.
","5-HT Agonists
","Rizatriptan binds with high affinity to human cloned 5-HT1B/1D receptors. Rizatriptan Benzoate presumably exerts its therapeutic effects in the treatment of migraine headache by binding to 5-HT1B/1D receptors located on intracranial blood vessels and sensory nerves of the trigeminal system.
","Dosing Information In Adults: The recommended starting dose of Rizatriptan Benzoate is either 5 mg or 10 mg for the acute treatment of migraines in adults. The 10-mg dose may provide a greater effect than the 5-mg dose, but may have a greater risk of adverse reactions.
Redosing In Adults: Although the effectiveness of a second dose or subsequent doses has not been established in placebocontrolled trials, if the migraine headache returns, a second dose may be administered 2 hours after the first dose. The maximum daily dose should not exceed 30 mg in any 24-hour period. The safety of treating, on average, more than four headaches in a 30-day period has not been established.
Dosing Information In Pediatric Patients (Age 6 to 17 Years): Dosing in pediatric patients is based on the patient's body weight. The recommended dose of Rizatriptan Benzoate is 5 mg in patients weighing less than 40 kg, and 10 mg in patients weighing 40 kg or more.
The efficacy and safety of treatment with more than one dose of Rizatriptan Benzoate within 24 hours in pediatric patients 6 to 17 years of age have not been established.
Dosage Adjustment For Patients On Propranolol: Sections or subsections omitted from the full prescribing information are not listed.
+
+- Adult Patients: In adult patients taking propranolol, only the 5-mg dose of Rizatriptan Benzoate is recommended, up to a maximum of 3 doses in any 24-hour period (15 mg)
+- Pediatric Patients: For pediatric patients weighing 40 kg or more, taking propranolol, only a single 5-mg dose of Rizatriptan Benzoate is recommended (maximum dose of 5 mg in a 24-hour period). Rizatriptan Benzoate should not be prescribed to propranolol-treated pediatric patients who weigh less than 40 kg
+
","Administration of Rizatriptan Benzoate Tablets, administration with liquid is not necessary. Orally disintegrating tablets are packaged in a blister within an outer aluminum pouch and patients should not remove the blister from the outer pouch until just prior to dosing. The blister pack should then be peeled open with dry hands and the orally disintegrating tablet placed on the tongue, where it will dissolve and be swallowed with the saliva.
","Propranolol: The dose of Rizatriptan should be adjusted in propranolol-treated patients, as propranolol has been shown to increase the plasma AUC of rizatriptan by 70%
Ergot-Containing Drugs: Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and Rizatriptan within 24 hours is contraindicated
Other 5-HT1 Agonists: Because their vasospastic effects may be additive, co-administration of Rizatriptan and other 5-HT1 agonists within 24 hours of each other is contraindicated
SSRIs /SNRIs And Serotonin Syndrome: Cases of serotonin syndrome have been reported during co-administration of triptans and selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)
Monoamine Oxidase Inhibitors: Rizatriptan is contraindicated in patients taking MAO-A inhibitors and non-selective MAO inhibitors. A specific MAO-A inhibitor increased the systemic exposure of rizatriptan and its metabolite
","Rizatriptan Benzoate is contraindicated in patients with:
+
+- Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or other significant underlying cardiovascular disease
+- Coronary artery vasospasm including Prinzmetal's angina
+- History of stroke or transient ischemic attack (TIA)
+- Peripheral vascular disease (PVD)
+- Ischemic bowel disease
+- Uncontrolled hypertension
+- Recent use (i.e., within 24 hours) of another 5-HT1 agonist, ergotamine-containing medication, or ergot-type medication (such as dihydroergotamine or methysergide)
+- Hemiplegic or basilar migraine
+- Concurrent administration or recent discontinuation (i.e., within 2 weeks) of a MAO-A inhibitor
+- Hypersensitivity to Rizatriptan Benzoate (angioedema and anaphylaxisseen)
+
","The following adverse reactions are discussed in more detail in other sections of the labeling:
+
+- Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina
+- Arrhythmias
+- Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure
+- Cerebrovascular Events
+- Other Vasospasm Reactions
+- Medication Overuse Headache
+- Serotonin Syndrome
+- Increase in Blood Pressure
+
","Pregnancy: Inform patients that Rizatriptan Benzoate should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Rizatriptan Benzoate is administered to a nursing woman. Rizatriptan is extensively excreted in rat milk, with levels in milk at least 5-fold higher than levels in maternal plasma.
","Elderly; mild to moderate hepatic or renal impairment; coronary artery disease; pregnancy, lactation. May cause drowsiness. History of seizures. Ensure an interval of at least 24 hr after stopping an ergotamine compound and starting a serotonin (5-HT1) agonist.
","Pediatric Use: Safety and effectiveness in pediatric patients under 6 years of age have not been established. The efficacy and safety of Rizatriptan in the acute treatment of migraine in patients aged 6 to 17 years was established in an adequate and well-controlled study. The incidence of adverse reactions reported for pediatric patients in the acute clinical trial was similar in patients who received Rizatriptan to those who received placebo. The adverse reaction pattern in pediatric patients is expected to be similar to that in adults.
Geriatric Use: Clinical studies of Rizatriptan did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
Although the pharmacokinetics of rizatriptan were similar in elderly (aged ≥65 years) and in younger adults (n=17), in general, dose selection for an elderly patient should be cautious, starting at the low end of the dosing range. This reflects the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Geriatric patients who have other cardiovascular risk factors (e.g., diabetes, hypertension, smoking, obesity, strong family history of coronary artery disease) should have a cardiovascular evaluation prior to receiving Rizatriptan
Renal Impairment: For mild-moderate impairment, initate with 5 mg. Further dose of 5 mg may be taken after an interval of at least 2 hr. Max: 10 mg/24 hr. Avoid in severe impairment.
Hepatic Impairment: For mild-moderate impairment, initate with 5 mg. Further dose of 5 mg may be taken after an interval of at least 2 hr. Max: 10 mg/24 hr. Avoid in severe impairment.
","May cause hypertension and CV symptoms. Gastric lavage using activated charcoal may be considered. Monitor ECG and clinical status of the patient.
",,,"Store at 15-30° C.
",13
+964,Rivastigmine Tartrate,rivastigmine-tartrate-964,https://medex.com.bd/attachments/2pJ4Gj9mUvRn6MunJxFgoR7cgnlq5e/rivastigmine-tartrate-capsule-and-oral-solution-prescribing-information,Drugs for Dementia,Dementia,"Symptomatic treatment of mild to moderately severe Alzheimer's dementia. Symptomatic treatment of mild to moderately severe dementia in patients with Idiopathic Parkinson's disease.
","Drugs for Dementia
","Rivastigmine is a carbamate derivative that is structurally related to physostigmine, but not to donepezil and tacrine. The precise mechanism of rivastigmine has not been fully determined, but it is suggested that rivastigmine binds reversibly with and inactivates chlolinesterase (eg. acetylcholinesterase, butyrylcholinesterase), preventing the hydrolysis of acetycholine, and thus leading to an increased concentration of acetylcholine at cholinergic synapses. The anticholinesterase activity of rivastigmine is relatively specific for brain acetylcholinesterase and butyrylcholinesterase compared with those in peripheral tissues.
","Rivastigmine capsule-
+
+- Initial dose: Rivastigmine 1.5 mg twice a day.
+- Dose titration: The starting dose is Rivastigmine 1.5 mg twice a day. If this dose is well tolerated after a minimum of two weeks of treatment, the dose may be increased to Rivastigmine 3 mg twice a day. Subsequent increases to 4.5 mg and then 6 mg twice a day should also be based on good tolerability of the current dose and may be considered after a minimum of two weeks of treatment at that dose level.
+- Maintenance dose: The effective dose is 3 mg to 6 mg twice a day; to achieve maximum therapeutic benefit patients should be maintained on their highest well tolerated dose. The recommended maximum daily dose is 6 mg twice a day. Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists.
+- Re-initiation of therapy: If treatment is interrupted for more than several days, it should be re-initiated at 1.5 mg twice daily. Dose titration should then be carried out as described above.
+
+Rivastigmine transdermal patch: Apply patch on intact skin for a 24-hour period; replace with a new patch every 24 hours.
+
+- Initial Dose: Initiate treatment with 4.6 mg/24 hours Rivastigmine transdermal patch.
+- Dose Titration: After a minimum of 4 weeks, if tolerated, increase dose to 9.5 mg/24 hours, which is the minimum effective dose. Following a minimum additional 4 weeks, may increase dosage to maximum dosage of 13.3 mg/24 hours.
+- Mild to Moderate Alzheimer's Disease and Parkinson’s Disease Dementia: Rivastigmine transdermal patch 9.5 mg/24 hours or 13.3 mg/24 hours once daily.
+- Severe Alzheimer’s Disease: Rivastigmine transdermal patch 13.3 mg/24 hours once daily.
+- For treatment interruption longer than 3 days, retitrate dosage starting at 4.6 mg per 24 hours.
+
","Rivastigmine should be administered twice a day, with morning and evening meals.
","As a cholinesterase inhibitor, Rivastigmine may exaggerate the effects of succinylcholine-type muscle relaxants during anaesthesia. Caution is recommended when selecting anaesthetic agents. Possible dose adjustments or temporarily stopping treatment can be considered if needed. In view of its pharmacodynamic effects, rivastigmine should not be given concomitantly with other cholinomimetic substances and might interfere with the activity of anticholinergic medicinal products. No pharmacokinetic interaction was observed between rivastigmine and digoxin, warfarin, diazepam or fluoxetine in studies in healthy volunteers. The increase in prothrombin time induced by warfarin is not affected by administration of rivastigmine. No untoward effects on cardiac conduction were observed following concomitant administration of digoxin and Rivastigmine.
","The use of this medicinal product is contraindicated in patients with hypersensitivity to the active substance or other carbamate derivatives.
","The most commonly reported adverse reactions are gastrointestinal, including nausea (38%) and vomiting (23%), especially during titration. Female patients in clinical studies were found to be more susceptible than male patients to gastrointestinal adverse reactions and weight loss.
","For Rivastigmine no clinical data are available. Rivastigmine should not be used during pregnancy unless clearly necessary. In animals, rivastigmine is excreted into milk. It is not known if rivastigmine is excreted into human milk. Therefore, women on rivastigmine should not breast-feed.
","Patients with sick sinus syndrome or conduction defects, resp diseases. Cholinergic stimulation may increase gastric acid secretion. May exacerbate urinary obstruction and seizures. Pregnancy. Renal impairment, mild to moderate hepatic impairment. Monitor body wt. Asthma or obstructive pulmonary disease. May worsen extrapyramidal symptoms. Lactation.
","Renal and hepatic impairment: Due to increased exposure in moderate renal and mild to moderate hepatic impairment, dosing recommendations to titrate according to individual tolerability should be closely followed
Use in children: Rivastigmine is not recommended for use in children.
","Most cases of accidental overdose have not been associated with any clinical signs or symptoms and almost all of the patients concerned continued rivastigmine treatment. Where symptoms have occurred, they have included nausea, vomiting and diarrhoea, hypertension or hallucinations. Due to the known vagotonic effect of cholinesterase inhibitors on heart rate, bradycardia and/or syncope may also occur. Ingestion of 46 mg occurred in one case; following conservative management the patient fully recovered within 24 hours. As rivastigmine has a plasma half-life of about 1 hour and a duration of acetylcholinesterase inhibition of about 9 hours, it is recommended that in cases of asymptomatic overdose no further dose of rivastigmine should be administered for the next 24 hours. In overdose accompanied by severe nausea and vomiting, the use of antiemetics should be considered. Symptomatic treatment for other adverse reactions should be given as necessary. In massive overdose, atropine can be used. An initial dose of 0.03 mg/kg intravenous atropine sulphate is recommended, with subsequent doses based on clinical response. Use of scopolamine as an antidote is not recommended.
",,,"Store in a cool and dry place, protected from light.
",13
+963,Rivaroxaban,rivaroxaban-963,https://medex.com.bd/attachments/3CoGB6O07Yy1a270SL8f2Ur3bM3fny/rivaroxaban-prescribing-information,Oral Anti-coagulants,Stroke,"Rivaroxaban 2.5 mg:
+
+- For the prevention of atherothrombotic events in adult patients after an Acute Coronary Syndrome (ACS) with elevated cardiac biomarkers (Troponin or CK-MB). It is co-administered with Aspirin alone or with Aspirin plus Clopidogrel orTidopidine.
+
+
Rivaroxaban 10-20 mg ... Read more Rivaroxaban 2.5 mg:
+
+- For the prevention of atherothrombotic events in adult patients after an Acute Coronary Syndrome (ACS) with elevated cardiac biomarkers (Troponin or CK-MB). It is co-administered with Aspirin alone or with Aspirin plus Clopidogrel orTidopidine.
+
+
Rivaroxaban 10-20 mg:
+
+- To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
+- Deep vein thrombosis (DVT) & pulmonary embolism (PE) and reduction in the risk of recurrence of DVT and of PE
+- For the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery
+
","Oral Anti-coagulants
","Rivaroxaban is a highly selective direct factor Xa inhibitor. Inhibition of factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibits thrombin formation. Rivaroxaban does not inhibit thrombin (activated factor II) and no effects on platelets have been demonstrated.
","Rivaroxaban 2.5 mg:
+
+- The recommended dose: 2.5 mg twice daily. Patients should also take a daily dose of 75-100 mg Aspirin or a daily dose of 75-100 mg Aspirin in addition to either a daily dose of 75 mg clopidogrel or a standard daily dose of ticlopidine.
+
+Rivaroxaban 10-20 mg:
+
+- Nonvalvular Atrial Fibrillation: For patients with Creatinin Clearance >50 mL/min: 20 mg orally, once daily with the evening meal. For patients with Creatinin Clearance 15-50 ml/min: 15 mg orally, once daily with the evening meal.
+- Treatment of DVT & PE: 15 mg orally twice daily with food for the first 21 days for the initial treatment of acute DVT or PE. After the initial treatment period, 20 mg orally once daily with food for the remaining treatment.
+- Prevention in the risk of recurrence of DVT and of PE: 20 mg once daily with food.
+- Prophylaxis of DVT following Hip replacement surgery: 10 mg once daily for 35 days.
+- Prophylaxis of DVT following knee replacement surgery: 10 mg once daily for 12 days.
+
+May be taken with or without food.
",,"Concomitant use with drugs that are combined P-gp and CYP3A4 inhibitors (ketoconazole, ritonavir, clarithromycin, erythromycin, fluconazole, diltiazem, verapamil, dronedarone) increases in Rivaroxaban exposure and pharmacodynamic effects (i.e., factor Xa inhibition and PT prolongation), that’s why should be avoided. Co-administration of Rivaroxaban with a combined P-gp and strong CYP3A4 inducer (e.g., rifampicin, phenytoin, carbamazepine) decreases the efficacy of Rivaroxaban and also should be avoided. The concomitant use of other drugs like anti-platelet agents, heparin, fibrinolytic therapy, NSAIDs may cause an increased risk of bleeding.
","It is contraindicated in patients with known hypersensitivity of Rivaroxaban or any of the excipients of the product. It is also contraindicated in patients with active pathological bleeding.
","The most common side effects of Rivaroxaban have increased chance of bleeding, spinal or epidural hematoma and increased risk of stroke after discontinuation in nonvalvular atrial fibrillation.
","Rivaroxaban is a pregnancy category C drug. There are no adequate or well-controlled studies of Rivaroxaban in pregnant women, and dosing for pregnant women has not been established. It is not known if Rivaroxaban is excreted in human milk. The safety and efficacy of Rivaroxaban has not been established in breastfeeding women.
","Early discontinuation of Rivaroxaban, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. Rivaroxaban increases the risk of bleeding that can be fatal in presence of following risk factors- bleeding disorders, uncontrolled severe arterial hypertension, gastrointestinal disease (e.g., inflammatory bowel disease, oesophagitis, gastritis and gastroesophageal reflux disease), vascular retinopathy, bronchiectasis, history of pulmonary bleeding. Signs or symptoms of neurological impairment should be monitored in case of neuraxial anesthesia (spinal/epidural anesthesia) or spinal puncture as epidural or spinal hematoma can occur. Rivaroxaban is not recommended in patients with pulmonary embolism who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.
",,"Overdose of Rivaroxaban may lead to hemorrhage. Rivaroxaban systemic exposure is not further increased at single doses >50 mg due to limited absorption. A specific antidote for Rivaroxaban is not available. The use of activated charcoal to reduce absorption in case of Rivaroxaban overdose may be considered. Partial reversal of laboratory anticoagulation parameters may be achieved with use of plasma products.
",,,"Store in a cool (below 30°C) & dry place protected from light. Keep away from the reach of children.
",11
+962,Rituximab,rituximab-962,https://medex.com.bd/attachments/4yUbiNCkEA0X2lyPvsntchDcQHlQp0/rituximab-prescribing-information,Cytotoxic immunosuppressants,Rheumatoid arthritis,"Non-Hodgkin's Lymphoma (NHL): Rituximab is indicated for the treatment of patients with-
+
+- Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
+- Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to Rituxan in combination with chemotherapy, as single-agent maintenance therapy.
... Read more
Non-Hodgkin's Lymphoma (NHL): Rituximab is indicated for the treatment of patients with-
+
+- Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
+- Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to Rituxan in combination with chemotherapy, as single-agent maintenance therapy.
+- Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line CVP chemotherapy
+- Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens
+
+
Chronic Lymphocytic Leukemia (CLL): Rituximab is indicated, in combination with fludarabine and cyclophosphamide (FC), for the treatment of patients with previously untreated and previously treated CD20-positive CLL.
Rheumatoid Arthritis (RA): Rituximab in combination with methotrexate is indicated for the treatment of adult patients with moderately- to severely- active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.
Granulomatos Is With Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA): Rituximab, in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) andMicroscopic Polyangiitis (MPA).
","Cytotoxic immunosuppressants
","Rituximab is a chimeric monoclonal antibody to CD20 antigen which regulates cell cycle initiation. It binds to the antigen on the cell surface, activating complement-dependent B-cell cytotoxicity; and to human Fc receptors, mediating cell killing through an antibody-dependent cellular toxicity.
Duration: Detectable in serum 3-6 mth after completion of therapy; B-cell recovery 6-12 mth following completion of therapy.
","Intravenous (Adult)-
Non-Hodgkin's lymphoma, Refractory or relapsed follicular lymphoma: As a single agent, 375 mg/m2 infusion once wkly, for 4 doses at an initial rate of 50 mg/hr. May increase by 50 mg/hr every 30 min. If tolerated, subsequent infusions can be started at 100 mg/hr and increased by 100 mg/hr every 30 min. Max rate: 400 mg/hr. When used with CVP (cyclophosphamide, vincristine and prednisolone) for follicular lymphoma or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) for diffuse large B-cell lymphoma, 375 mg/m2 given on day 1 of the chemotherapy cycle after corticosteroid regimen, for up to 8 cycles. For patients who were treated with 6-8 cycles of CVP chemotherapy and have not progressed, 375 mg/m2 may be given once wkly for 4 doses, may repeat every 6 mth, for up to 16 doses. Maintenance: 375 mg/m2 given once every 3 mth (those who have responded to induction chemotherapy), once every 2 mth initiated 2 mth after the last dose of induction chemotherapy (previously untreated) for a max period of 2 yr.
Chronic lymphocytic leukaemia: 375 mg/m2, given on the day prior to chemotherapy in cycle 1, followed by 500 mg/m2 on day 1 (every 28 days) of cycles 2-6.
Rheumatoid arthritis: Given as two 1 g IV infusion doses, separated by 2 wk and in combination with methotrexate. Corticosteroids may be given before each infusion to minimise the risk and severity of infusion reactions.
",,"Increased risk of renal toxicity with cisplatin.
","Hypersensitivity to murine proteins. Patients with active, severe infections. Severely immunocompromised state. Concomitant use with live viral vaccines. Lactation.
","Reactivation of hepatitis B virus. Fever and rigors. Pruritus, skin rashes, dyspnoea, bronchospasm, angioedema, transient hypotension, and flushing, asthenia, headache, rhinitis, thrombocytopenia, neutropenia, anaemia, abdominal pain, bowel obstruction, and perforation. Exacerbation of heart failure and angina pectoris. Reversible interstitial pneumonia and interstitial fibrosis. Depletion of immunoglobulin concentrations.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Extensive tumour burden, pulmonary insufficiency or pulmonary tumour infiltration; history of cardiac disease. Pregnancy.
",,,,"Dilute the appropriate dose with sodium chloride 0.9% or glucose 5% to a final concentration of between 1 and 4 mg/mL.
","Store between 2-8° C.
",11
+961,Ritodrine Hydrochloride,ritodrine-hydrochloride-961,,Drugs acting on the Uterus,Premature labour,"Ritodrine is indicated for the treatment of uncomplicated premature labour
","Drugs acting on the Uterus
","A selective β2-adrenoceptor agonist with its main action on the uterus, causing relaxation. It reduces the intensity and frequency of contractions. Heart rate is also increased while diastolic pressure is reduced. May cause bronchial relaxation but this is not clinically significant in its usage.
","By intravenous infusion: Initially 50 mcg/minute, increased gradually according to response by 50 mcg/minute every 10 minutes until contractions stop or maternal heart rate reaches 140 beats/minute; continue for 12–48 hours after contractions cease (usual rate 150–350 mcg/minute); maximum rate 350 mcg/minute.
Intramuscular injection: 10 mg in every 3–8 hours continued for 12–48 hours after contractions have ceased; then by mouth.
Oral maintenance treatment: One tablet (10 mg) may be given approximately 30 minutes before termination of intravenous therapy, repeated every 2 hours for 24 hours, followed by 10–20 mg every 4–6 hours, maximum oral dose 120 mg daily
",,"Increased risk of hypokalamia if high doses of corticosteroids, diuretics (acetazalamide, loop diuretics and thiazides) or theophylline given with high doses of ritodrine. A sufficient time interval should elapse prior to administration of another sympathomimetic drug. β–adrenergic blocking drugs inhibit its action; coadministraton of these drugs should, therefore, be avoided. With anesthetics used in surgery, the possibility that hypotensive effects may be potentiated should be considered.
","It is contraindicated in patients with known hypersensitivity to the active ingredient or any of the excipients of this component. β2-agonists are contra-indicated in cardiac disease and in patients with significant risk factors for myocardial ischaemia; they should also be avoided in antepartum haemorrhage, intra-uterine infection, intra-uterine fetal death, placenta praevia, abruptio placenta, threatened miscarriage, cord compression, and eclampsia or severe preeclampsia.
","The common side-effects of ritodrine hydrochloride are nausea, vomiting, flushing, sweating, tremor, hypokalaemia, tachycardia, palpitations, hypotension (left lateral position throughout infusion to minimize risk), uterine bleeding, pulmonary oedema; chest pain or tightness, arrhythmias and salivary gland enlargement. On prolonged administration for several weeks may cause leucopenia and agranulocytosis; liver function abnormalities including increased transaminases and hepatitis.
","Ritodrine is a drug of pregnancy category B. There are no adequate and well controlled studies of effects in pregnant women before 20 weeks gestation; therefore, this drug should not be used before the 20th week of pregnancy. Studies in pregnant women from the 20th week of gestation onwards have not shown increased risk of fetal abnormalities. Nonetheless, although clinical studies did not indicate a risk of permanent adverse fetal effects from ritodrine, the possibility cannot be excluded; therefore, it should be used only when clearly indicated. In frequently reported neonatal symptoms include hypoglycemia and ileus. In addition, hypocalcemia and hypotension have been reported in neonates whose mothers were treated with other beta mimetic agents. Caution should be exercised unless the potential benefit of treatment to the mother outweighs any possible risk of the infants.
","It should be used cautiously in patient with suspected cardiac diseases, hypertension, hyperthyroidism, hypokalaemia, diabetes mellitus, mild to moderate preeclampsia, monitor blood pressure and pulse rate and avoid over-hydration during taking ritodrine hydrochloride.
",,"Symptoms of overdosage are tachycardia (maternal and fetal), palpitation, cardiac arrhythmia, hypotension, nervousness, tremor, nausea and vomiting. If an excess of ritodrine tablets is ingested, gastric lavage or induction of emesis should be carried out followed by administration of activated charcoal. When symptoms of overdose occur as a result of parenteral administration, ritodrine should be discontinued; an appropriate β-blocking agent may be used
as an antidote.
",,,"Keep away from the reach of the children. Store in cool & dry place protected from light
",11
+960,Risperidone (Oral),risperidone-oral-960,https://medex.com.bd/attachments/Ctf2yLRRptHsrwNQMHreWriIIWLPlD/risperidone-oral-prescribing-information,Atypical neuroleptic drugs,Unipolar and bipolar depression,"Risperidone tablet is indicated for the treatment of-
+
+- Acute and chronic psychoses
+- Mania
+- Schizophrenia
+
","Atypical neuroleptic drugs
","Risperidone is a selective monoaminergic antagonist having a high affinity for serotoninergic 5-HT2 and dopaminergic D2 receptors. Risperidone binds also to alpha1 adrenergic receptors and with lower affinity, to H1 histamine and alpha2 adrenergic receptors. Risperidone has no affinity for 8 cholinergic receptors. Risperidone, as a potent D2 antagonist, improves the positive symptoms of schizophrenia but causes less depression of motor activity. Balanced central serotonin and dopamine antagonism may reduce extrapyramidal side effect liability and extend the therapeutic activity to the negative and affective symptoms of schizophrenia.
","Psychoses:
+
+- 2 mg in 1-2 divided doses on 1st day then 4 mg in 1-2 divided doses on second day (Slower titration appropriate in some patients);
+- Usual dose range 4-6 mg daily; doses above 10 mg daily only if benefit considered to outweigh risk (max. 16 mg daily).
+- Elderly (or in hepatic or renal impairment) initially 1 mg daily in two divided doses increased in steps of 1-2 mg twice daily.
+- Child under 15 years not recommended.
+
+
Mania:
+
+- Initially, 2 mg once daily increased if necessary in step of 1 mg daily; usual dose range 1-6 mg daily;
+- Elderly (or in hepatic or renal impairment) initially 1 mg daily in two divided doses increased in steps of 1-2 mg twice daily.
+
+
Schizophrenia:
+
+- Risperidone should be generally administered at 1 mg BID initially, with increases in increments of 1 mg BID on the second and third day, as tolerated, to a target dose of 3 mg BID by the third day.
+- Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week. When dosage adjustments are necessary, small dose increments/decrements of 1-2 mg are recommended.
+
",,"Risperidone May antagonize the effects of levodopa and dopamine agonists. Chronic administration with Carbamazepine reduces plasma clearance of Risperidone. Chronic administration with Clozapine may decrease the clearance of Risperidone. Risperidone may enhance the effects of certain antihypertensives.
","Risperidone is contraindicated in patients with a known hypersensitivity to the product.
","Insomnia, agitation, anxiety, headache, less commonly drowsiness, impaired concentration, fatigue, blurred vision, constipation, nausea and vomiting, dyspepsia, abdominal pain, hyperprolactinaemia, urine incontinence, tachycardia, hypertension, edema, rash, rhinitis, cerebrovascular accident, neurtropenia and thrombocytopenia have been reported.
","Although, in experimental animals, Risperidone did not show direct reproductive toxicity, some indirect, prolactin- and CNS-mediated effects were observed, No teratogenicity effect of Risperidone was noted in any study. The safety of Risperidone for use during human pregnancy has not been established. In animal studies, Risperidone and 9-hydroxyrisperidone are excreted in the milk. It has been demonstrated that Risperidone and 9-hydroxyrisperidone are also excreted in human breast milk. Therefore, women receiving Risperidone should not breastfeed.
","Special precaution should be taken in case of preexisting cardiovascular diseases, discontinue use if signs and symptoms of tardive dyskinesia occur, renal and hepatic impairment, elderly epilepsy, Parkinson's disease and in pregnancy.
",,,,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",10
+1553,Risperidone (Injection),risperidone-injection-1553,,Atypical neuroleptic drugs,Schizophrenia,"Risperidone injection is an atypical antipsychotic indicated:
+
+- For the treatment of schizophrenia.
+- As monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder.
+
","Atypical neuroleptic drugs
","The mechanism of action of risperidone in schizophrenia is unclear. The drug’s therapeutic activity in schizophrenia could be mediated through a combination of dopamine Type 2 (D2) and serotonin Type 2 (5HT2) receptor antagonism. The clinical effect from risperidone results from the combined concentrations of risperidone and its major active metabolite, 9-hydroxyrisperidone (paliperidone). Antagonism at receptors other than D2 and 5HT 2 may explain some of the other effects of risperidone
","For patients who have never taken oral Risperidone, tolerability should be established with oral Risperidone prior to initiating treatment with Risperidone.
Administer by deep intramuscular (IM) deltoid or gluteal injection. Each injection should be administered by a health care professional using the appropriate enclosed safety needle (1-inch for deltoid administration alternating injections between the two arms and 2-inch for gluteal administration alternating injections between the two buttocks). Do not administer intravenously.
25 mg intramuscular (IM) every 2 weeks. Patients not responding to 25 mg may benefit from a higher dose of 37.5 mg or 50 mg. The maximum dose should not exceed 50 mg every 2 weeks.
Oral Risperidone (or another antipsychotic medication) should be given with the first injection of Risperidone, and continued for 3 weeks (and then discontinued) to ensure adequate thera peutic plasma concentrations from Risperidone
Upward dose adjustment of Risperidone should not be made more frequently than every 4 weeks. Clinical effects of each upward dose adjustment should not be anticipated earlier than 3 weeks after injection.
Avoid inadvertent administration into a blood vessel.
",,"
+- Due to CNS effects, use caution when administering with other centrally-acting drugs. Avoid alcohol.
+- Due to hypotensive effects, hypotensive effects of other drugs with this potential may be enhanced.
+- Effects of levodopa and dopamine agonists may be antagonized.
+- Cimetidine and ranitidine increase the bioavailability of risperidone.
+- Clozapine may decrease clearance of risperidone.
+- Fluoxetine and paroxetine increase plasma concentrations of risperidone.
+- Carbamazepine and other enzyme inducers decrease plasma concentrations of risperidone.
+
","Known hypersensitivity to risperidone, paliperidone, or to any excipients in Risperidone
","
+- Increased mortality in elderly patients with dementia-related psychosis
+- Cerebrovascular adverse events, including stroke, in elderly patients with dementia-related psychosis
+- Neuroleptic malignant syndrome
+- Tardive dyskinesia
+- Metabolic changes
+- Hyperprolactinemia
+- Orthostatic hypotension
+- Falls
+- Leukopenia/Neutropenia and Agranulocytosis
+- Potential for cognitive and motor impairment
+- Seizures
+- Dysphagia
+- Priapism
+- Thrombotic Thrombocytopenic Purpura (TTP)
+- Disruption of body temperature regulation
+- Avoidance of inadvertent injection into a blood vessel
+
","Pregnancy: Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with Risperidone
Lactation: Advise breastfeeding women using Risperidone to monitor infants for somnolence, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements) and to seek medical care if they notice these signs
","
+- Increased Mortality in Elderly Patients with Dementia-Related Psychosis
+- Cerebrovascular Adverse Events, Including Stroke, in Elderly Patients with Dementia-Related Psychosis
+- Neuroleptic Malignant Syndrome
+- Tardive Dyskinesia
+- Hyperprolactinemia
+- Orthostatic Hypotension
+
","Renal or Hepatic Impairment: dose appropriately with oral Risperidone prior to initiating treatment with Risperidone. A lower starting dose of Risperidone of 12.5 mg may be appropriate in some patients.
Pediatric Use: safety and effectiveness not established in patients less than 18 years of age.
Elderly: dosing for otherwise healthy elderly patients is the same as for healthy nonelderly. Elderly may be more predisposed to orthostatic effects than nonelderly.
",,,,"The entire dose pack should be stored in the refrigerator (2°-8°C) and protected from light. Keep out of reach of children.
",11
+1450,Risedronate Sodium + Calcium,risedronate-sodium-calcium-1450,,Bisphosphonate preparations,Osteoporosis,"
+- To prevent and treat osteoporosis in postmenopausal women.
+- To increase bone mass in men with osteoporosis.
+- To prevent and treat osteoporosis in men and women that is caused by treatment with Steroid medicines such as prednisolone.
+- To treat Paget’s disease of bone in men and women.
+
","Bisphosphonate preparations
","Risedronate has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, Risedronate inhibits osteoclasts. The osteoclasts adhere normally to the bone surface, but show evidence of reduced active resorption.
Calcium suppresses parathyroid hormone (PTH) secretion and decreases bone turnover. Increased levels of PTH are known to contribute to age-related bone loss, especially at cortical sites, while increased bone turnover is an independent risk factor of fractures.
","This is a co-package product containing 1 tablet of Risedronate Sodium 35 mg for once weekly dosing and 6 tablets of Calcium Carbonate 500 mg for daily dosing of the remaining 6 days of the week. Risedronate is in a group of medicines called bisphosphonates. It alters the cycle of bone formation and breakdown in the body. It slows bone loss while increasing bone mass, which may prevent bone fractures.
","The following instructions are applicable to all patients taking this tablet:
+
+- Take this tablet exactly as prescribed by your healthcare provider
+- At first take this tablet in the morning before you eat or drink anything except plain water.
+- Take this tablet while you are sitting up or standing.
+- Take a this tablet with 1 glass of plain water. Do not take it with any other drink besides plain
+- water.
+- Swallow whole this tablet. Do not chew the tablet or keep it in your mouth to melt or dissolve.
+- After taking this tablet you must wait at least 30 minutes before: lying down. You may sit, stand, or do normal activities. Eating or drinking anything except plain water. Taking vitamins, calcium, or antacids.
+- Take vitamins, calcium, & antacids at a different time of the day from when you take this tablet.
+- Keep taking this tablet for as long as your healthcare provider tells you.
+
+
SCHEDULE: One this tablet should be taken orally once a week (Day 1 of the 7-day treatment cycle). One calcium 500 mg tablet should be taken orally with food daily on each of the remaining six days (Days 2 through 7 of the 7-day treatment cycle).
","Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription specially aspirin or other NSAIDs. Antacids, supplements, or medicines that contain aluminum, calcium, magnesium, or other minerals can interfere with the absorption of Risedronate Sodium. If you use these other medicines, do not take these for at least 30 minutes after taking a Risedronate Sodium tablet.
",,"Chest pain, difficulty or pain when swallowing, pain or burning under the ribs or in the back, new or worsening heartburn, severe joint, bone, or muscle pain, jaw pain, numbness, or swelling, mild heartburn or stomach upset, diarrhea, gas, or constipation, mild joint or back pain, headache.
","PREGNANCY: It should not be taken during pregnancy. If you take it by accident during pregnancy, stop taking it straight away and talk to your doctor.
LACTATION: Breast-feeding women should not take this medicine. If you take it by accident during breast-feeding, stop taking it straight away and talk to your doctor.
","Take special care with if you:
+
+- Have low blood calcium (hypocalcemia).
+- Cannot sit or stand up for 30 minutes.
+- Have kidneys that work poorly.
+- Have an allergy to Risedronate Sodium.
+- Are pregnant or may become pregnant.
+- Are breast-feeding or plan to breast-feed.
+- Have kidney problems, Risedronate Sodium may not be right for you.
+
","FOR RENAL IMPAIRED PATIENTS: Risedronate Sodium is not recommended for use in patients with severe renal impairment (creatinine clearance <30 ml/min). No dosage adjustment is necessary in patients with a creatinine clearance >30 ml/min or in the elderly.
",,,,"Store in a cool and dry place. Protect from light & moisture. Keep out of the reach of children.
",11
+959,Risedronate Sodium,risedronate-sodium-959,https://medex.com.bd/attachments/KgObiNndkaiZpSa7W4JGN5FO15M4U4/risedronate-sodium-prescribing-information,Bisphosphonate preparations,Post-menopausal osteoporosis,"This is in a group of medicines called bisphosphonates. It alters the cycle of bone formation and breakdown in the body. It slows bone loss while increasing bone mass, which may prevent bone fractures. Risedronate is a prescription medicine used:
+
+- To prevent and treat osteoporosis in postmenopausal women.
... Read more
This is in a group of medicines called bisphosphonates. It alters the cycle of bone formation and breakdown in the body. It slows bone loss while increasing bone mass, which may prevent bone fractures. Risedronate is a prescription medicine used:
+
+- To prevent and treat osteoporosis in postmenopausal women.
+- To increase bone mass in men with osteoporosis.
+- To prevent and treat osteoporosis in men and women that is caused by treatment with steroid medicines such as prednisone.
+- To treat Paget’s disease of bone in men and women.
+
","Bisphosphonate preparations
","Risedronate has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, Risedronat inhibits osteoclasts. The osteoclasts adhere normally to the bone surface, but show evidence of reduced active resorption.
","Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures: The recommended dose is Risedronate Sodium 5 mg once daily or Risedronate Sodium 35 mg once weekly on the same day each week or Risedronate Sodium 150 mg once monthly.
Prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis: The recommended dose is Risedronate Sodium 5 mg once daily.
To maintain or increase bone mass in postmenopausal women undergoing long-term (more than 3 months): Systemic corticosteroid treatment at doses 7.5 mg/day prednisone or equivalent. The recommended dose is Risedronate Sodium 5 mg once daily.
Treatment of osteoporosis in men at high risk of fractures: The recommended dose is Risedronate Sodium 35 mg once weekly. The tablet should be taken on the same day each week.
","The absorption of Risedronate Sodium is affected by food, thus to ensure adequate absorption patients should take Risedronate tablets at least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day. In the particular instances that before breakfast dosing is not practical, Risedronate 5 mg tablet can be taken between meals or in the evening at the same time everyday, with strict adherence to the following instructions, to ensure Risedronate Sodium tablet is taken on an empty stomach-Between meals:
Risedronate Sodium tablet should be taken at least 2 hours before and at least 2 hours after any food, medicinal product or drink (other than plain water). In the evening:
Risedronate Sodium tablet should be taken at least 2 hours after the last food, medicinal product or drink (other than plain water) of the day. If a dose is missed: Risedronate 5 mg tablet: If an occasional dose is missed, Risedronate 5 mg tablet can be taken before breakfast, between meals, or in the evening according to the instructions above.
Risedronate 35 mg tablet: Patients should be instructed that if a dose is missed, just take one Risedronate 35 mg tablet on the morning after remember. Patients should then return to taking one tablet once a week on the day the tablet is normally taken. Two tablets should not be taken on the same day.
Risedronate 150 mg tablet: Patient should be instructed that if a dose is missed and the next month’s schedule dose is more than 7 days away, then should take the missed tablet in the morning after the day it is remembered. Patients should then return to taking one tablet once a month normally taken.The tablet must be swallowed whole and not sucked or chewed. To aid delivery of the tablet to the stomach Risedronate tablet is to be taken while in an upright position with a glass of plain water (120 ml or more). Patients should not lie down for 30 minutes after taking the tablet. Supplemental calcium and vitamin D should be considered if the dietary intake is inadequate.
","Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription specially aspirin or other NSAIDs. Antacids, supplements, or medicines that contain aluminum, calcium, magnesium, or other minerals can interfere with how your body absorbs Risedronate Sodium. If you use these other medicines, do not take them for at least 30 minutes after taking a Risedronate Sodium tablet.
","Risedronate Sodium tablet is contraindicated in patients with known hypersensitivity to Risedronate Sodium and in patients with hypocalcaemia, severe renal impairment (creatinine clearance lower than 30 ml/min), during pregnancy and lactation.
","Serious side effects:
+
+- chest pain;
+- difficulty or pain when swallowing;
+- pain or burning under the ribs or in the back;
+- new or worsening heartburn;
+- severe joint, bone, or muscle pain; or
+- jaw pain, numbness, or swelling.
+
+Less serious side effects:
+
+- mild heartburn or stomach upset;
+- diarrhea, gas,or constipation;
+- mild joint or back pain;
+- headache.
+
","Pregnancy: Risedronate Sodium is meant for use only in postmenopausal women. Therefore, Risedronate Sodium should not be taken during pregnancy. If you take it by accident during pregnancy, stop taking it straight away and talk to your doctor.
Breast-feeding: Risedronate Sodium is meant for use only in postmenopausal women. Therefore, breast-feeding women should not take this medicine. If you take it by accident during breast-feeding, stop taking it straight away and talk to your doctor.
","Take special care with Risedronate if you:
+
+- Have low blood calcium (hypocalcemia)
+- Cannot sit or stand up for 30 minutes
+- Have kidneys that work poorly
+- Have an allergy to Risedronate Sodium
+
+Before taking Risedronate talk to doctor if you:
+
+- Are pregnant or may become pregnant. We do not know if Risedronate Sodium can harm your unborn child.
+- Are breast-feeding or plan to breast-feed. We do not know if Risedronate Sodium can passthrough your milk and if it can harm your baby.
+- Have kidney problems Risedronate Sodium may not be right for you.
+- Risedronate sodium is not intended for use in children.
+
+During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), you must stop taking Risedronate sodium and seek medical advice immediately. If you have stopped treatment due to hypersensitivity reactions you should not re-start therapy with Risedronate sodium.
","Elderly: No dosage adjustment is necessary since bioavailability, distribution and elimination were similar in elderly (60 years of age or older) compared to younger subjects. This has also been shown in the very elderly, 75 years old and above postmenopausal population.
Renal impairment: No dosage adjustment is required for those patients with mild to moderate renal impairment. The use of Risedronate Sodium is contra-indicated in patients with severe renal impairment (Creatinine clearance lower than 30ml/min).
","Seek emergency medical attention if you think you have used too much of this medicine. Drink a full glass of milk right away. Do not make yourself vomit and do not lie down.
Overdose symptoms may include nausea, heartburn, stomach pain, diarrhea, muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.
",,,"Store in a cool and dry place. Protect from light & moisture. Keep out of the reach of children.
",13
+178,Ringer's Lactate Solution,ringers-lactate-solution-178,https://medex.com.bd/attachments/f4OMIL2o3aPNfWVLaA3X66EOCVFPWo/ringers-lactate-solution-prescribing-information,Intravenous fluid preparations,Hypovolemia,"Ringer's lactate solution is indicated for diarrhea, dehydration, water and electrolytes imbalance, alkalinizing agent, diabetic coma, cholera. This solution is very often used for fluid resuscitation after a blood loss due to trauma, surgery, or a burn injury. Ringer's lactate ... Read more
Ringer's lactate solution is indicated for diarrhea, dehydration, water and electrolytes imbalance, alkalinizing agent, diabetic coma, cholera. This solution is very often used for fluid resuscitation after a blood loss due to trauma, surgery, or a burn injury. Ringer's lactate solution is used because the by-products of lactate metabolism in the liver counteract acidosis, which is a chemical imbalance that occurs with acute fluid loss or renal failure.
","Intravenous fluid preparations
","Lactated Ringer's solution contains isotonic concentrations of electrolytes in water for inj. It is used for parenteral replacement of extracellular losses of fluid and electrolytes. Lactated Ringer’s Injection, produces a metabolic alkalinizing effect. Lactate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.
Calcium chloride is used to prevent or treat negative calcium balance. It also regulates action potential excitation threshold to facilitate nerve and muscle performance.
Potassium chloride is a major cation of the intracellular fluid. It plays an active role in the conduction of nerve impulses in the heart, brain and skeletal muscle; contraction of cardiac skeletal and smooth muscles; maintenance of normal renal function, acid-base balance, carbohydrate metabolism and gastric secretion.
Sodium chloride is the major extracellular cation. It is important in electrolyte and fluid balance, osmotic pressure control and water distribution as it restores sodium ions. It is used as a source of electrolytes and water for hydration, treatment of metabolic acidosis, priming solution in haemodialysis and treatment of hyperosmolar diabetes. It is also used as diluents for infusion of compatible drug additives.
","The IV dose of Ringer's lactate solution is usually calculated by estimated fluid loss and presumed fluid deficit. For fluid resuscitation the usual rate of administration is 20 to 30 ml/kg body weight/hour. RL is not suitable for maintenance therapy (i.e., maintenance fluids) because the sodium content (130 mEq/L) is considered too low, particularly for children, and the potassium content (4 mEq/L) is too low, in view of electrolyte daily requirement. Moreover, since the lactate is converted into bicarbonate, longterm use will cause patients to become alkalotic. Ringer's lactate and other crystalloids are also used as vehicles for the IV delivery of drugs.
In a large-volume resuscitation over several hours, LRS maintains a more stable blood pH than normal saline.
",,"There are no known drug interactions and none well documented.
","Hypersensitivity.
","Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia.
","Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 5% Dextrose in Lactated Ringer’s Injection is administered to a nursing woman.
","IV infusion is obsolete in metabolic acidosis and carries the risk of producing lactic acidosis, particularly in seriously ill patients with poor tissue perfusion and on impaired hepatic function.
",,,,,,9
+1270,Rimexolone,rimexolone-1270,https://medex.com.bd/attachments/5EIKltMdkPzwjXmtakJ6Cqx4RjM09g/rimexolone-prescribing-information,Ophthalmic Steroid preparations,Ocular inflammation,"Rimexolone ophthalmic suspension is indicated for the treatment of postoperative inflammation following ocular surgery and in the treatment of anterior uveitis.
","Ophthalmic Steroid preparations
","Rimexolone is a glucocorticoid receptor agonist. The antiinflammatory actions of corticosteroids are thought to involve lipocortins, phospholipase A2 inhibitory proteins which, through inhibition of arachidonic acid, control the biosynthesis of prostaglandins and leukotrienes. By binding to the glucocorticoid receptor, this drug ultimately leads to changes in genetic transcription involving the lipocortins and prostaglandins.
","Post-Operative Inflammation: Apply one to two drops of Rimexolone 1% Ophthalmic Suspension into the conjunctivalsac of the affected eye four times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period.
Anterior Uveitis: Apply one to two drops of Rimexolone 1% Ophthalmic Suspension into the conjunctival sac of the affected eye every hour during waking hours for the first week, one drop every two hours during waking hours of the second week, and then taper until uveitis is resolved.
",,"No information provided
","Rimexolone 1% (rimexolone ophthalmic suspension) is contraindicated in epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and most other viral diseases of the cornea and conjunctiva; mycobacterial infection of the eye; fungal diseases of the eye; acute purulent untreated infections which, like other diseases caused by microorganisms, may be masked or enhanced by the presence of the steroid; and in those persons with hypersensitivity to any component of the formulation.
","Reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.
Ocular adverse reactions occurring in 1 - 5% of patients in clinical studies of Rimexolone 1% (rimexolone ophthalmic suspension) included blurred vision, discharge, discomfort, ocular pain, increased intraocular pressure, foreign body sensation, hyperemia and pruritus.
Other ocular adverse reactions occurring in less than 1% of patients included sticky sensation, increased fibrin, dry eye, conjunctival edema, corneal staining, keratitis, tearing, photophobia, edema, irritation, corneal ulcer, browache, lid margin crusting, corneal edema, infiltrate, and corneal erosion.
Non-ocular adverse reactions occurred in less than 2% of patients. These included headache, hypotension, rhinitis, pharyngitis, and taste perversion.
","Pregnancy Category C. Rimexolone has been shown to be teratogenic and embryotoxic in rabbits following subcutaneous administration at the lowest dose tested (0.5 mg/kg/day, approximately 2 times the recommended human ophthalmic dose). Corticosteroids are recognized to cause fetal resorptions and malformations in animals. There are no adequate and well-controlled studies in pregnant women. Rimexolone 1% (rimexolone ophthalmic suspension) should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human breast milk. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman; a decision should be made whether to discontinue nursing or discontinue therapy, taking into consideration the importance of the drug to the mother.
","Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungal invasion must be considered in any persistent corneal ulceration where a steroid has been or is in use.
For ophthalmic use only. Use of the same bottle for both eyes is not recommended with topical eye drops that are used in association with surgery.
The initial prescription and renewal of the medication order beyond 14 days should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be reevaluated. If this product is used for 10 days or longer,intraocular pressure should be monitored even though it may be difficult in children and uncooperative patients
","Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
",,,,"Store upright between 2-25° C. Do not freeze. Shake well before use.
",11
+1421,Riluzole,riluzole-1421,https://medex.com.bd/attachments/pd7DG1VjTPluNsAjxzH603aZNRw0lJ/riluzole-prescribing-information,Neurodegenerative Disease Drugs / Neuromuscular Disorder Drugs,Abdominal pain,"Riluzole is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
","Neurodegenerative Disease Drugs / Neuromuscular Disorder Drugs
","The mode of action of riluzole is unknown. Its pharmacological properties include the following, some of which may be related to its effect:
+
+- An inhibitory effect on glutamate release (activation of glutamate reuptake),
+- Inactivation of voltage-dependent sodium channels,
+- Ability to interfere with intracellular events that follow transmitter binding at excitatory amino acid receptors.
+
","The recommended dosage for Riluzole is 50 mg taken orally twice daily. Riluzole should be taken at least 1 hour before or 2 hours after a meal. Measure serum aminotransferases before and during treatment with Riluzole
",,"Strong to moderate CYP1A2 inhibitors: Coadministration may increase Riluzole-associated adverse reactions
Strong to moderate CYP1A2 inducers: Coadministration may result in decreased efficacy
Hepatotoxic drugs: Riluzole-treated patients that take other hepatotoxic drugs may be at increased risk for hepatotoxicity
","Riluzole is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred)
","The following adverse reactions are described below and elsewhere in the labeling: Hepatic Injury, Neutropenia, Interstitial lung disease
","Pregnancy: Based on animal data, may cause fetal harm
Lactation: It is not known if riluzole is excreted in human milk. Riluzole or its metabolites have been detected in milk of lactating rat. Women should be advised that many drugs are excreted in human milk and that the potential for serious adverse reactions in nursing infants from Riluzole is unknown.
","Hepatic Injury: Cases of drug-induced liver injury, some of which were fatal, have been reported in patients taking Riluzole. Asymptomatic elevations of hepatic transaminases have also been reported, and in some patients have recurred upon rechallenge with Riluzole.
In clinical studies, the incidence of elevations in hepatic transaminases was greater in Riluzoletreated patients than placebo-treated patients. The incidence of elevations of ALT above 5 times the upper limit of normal (ULN) was 2% in Riluzole-treated patients. Maximum increases in ALT occurred within 3 months after starting Riluzole. About 50% and 8% of Riluzoletreated patients in pooled Studies 1 and 2, had at least one elevated ALT level above ULN and above 3 times ULN, respectively
Monitor patients for signs and symptoms of hepatic injury, every month for the first 3 months of treatment, and periodically thereafter. The use of Riluzole is not recommended if patients develop hepatic transaminases levels greater than 5 times the ULN. Discontinue Riluzole if there is evidence of liver dysfunction (e.g., elevated bilirubin).
Neutropenia: Cases of severe neutropenia (absolute neutrophil count less than 500 per mm3) within the first 2 months of Riluzole treatment have been reported. Advise patients to report febrile illnesses.
Interstitial Lung Disease: Interstitial lung disease, including hypersensitivity pneumonitis, has occurred in patients taking Riluzole. Discontinue Riluzole immediately if interstitial lung disease develops.
",,"Reported symptoms of overdose following ingestion of Riluzole ranging from 1.5 to 3 grams (30 to 60 times the recommended dose) included acute toxic encephalopathy, coma, drowsiness, memory loss, and methemoglobinemia. No specific antidote for the treatment of Riluzole overdose is available.
",,,"Store at controlled room temperature, 20°C to 25°C, and protect from bright light.
",11
+957,Rifaximin,rifaximin-957,https://medex.com.bd/attachments/FQmAqCZ9tZted7ysqcGbr5YJ6e15BY/rifaximin-prescribing-information,4-Quinolone preparations,Traveller’s diarrhea,"Rifaximin is indicaed in-
+
+- Treatment of traveler's diarrhea by noninvasive strains of E. coli
+- reduction in risk of overt hepatic encephalopathy
+- bacterial overgrowth of irritable bowel syndrome.
+
","4-Quinolone preparations
","Rifaximin is a semisynthetic, rifamycin-based non-systemic antibiotic. Very little of the drug will pass the gastrointestinal wall into the circulation as is common for other types of orally administered antibiotics. Rifaximin inhibits bacterial RNA synthesis by its action on the beta-subunit of the DNA-dependent RNA polymerase. It shows the same broad spectrum activity as rifamycin which exerts bactericidal action against many species of Gram-positive and Gram-negative, aerobic and anaerobic bacteria.
","Traveler's Diarrhea: For patients ≥12 years of age: 200 mg 3 times daily for 3 days.
Hepatic Encephalopathy: For patients ≥18 years of age: 550 mg 2 times daily.
Bacterial overgrowth of irritable bowel syndrome: 400 mg 3 times daily for 10 days or 550 mg 3 times daily for 14 days. Can be taken with or without food
",,"In an in vitro study has suggested that Rifaximin induces CYP3A4. However, in patients with normal liver function, Rifaximin at the recommended dosing regimen is not expected to induce CYP3A4.
","Contraindicated in patients with a hypersensitivity to Rifaximin or to any of the rifamycin antimicrobial agents, or any components of this product
","Side effects include flatulence, headache, abdominal pain, rectal tenesmus, defecation urgency, nausea, constipation, pyrexia, vomiting. Reactions have been reported, including anaphylaxis, angioneurotic edema, and exfoliative dermatitis.
","Pregnancy category C. It is not known whether Rifaximin is excreted in human milk or not.
","Rifaximin is not found to be effective in patients with diarrhea complicated by fever and/or blood in the stools. Rifaximin therapy should be discontinued if diarrhea symptoms get worse or persist for more than 24-48 hours and alternative antibiotic therapy should be considered. Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
","Renal Impairment: The pharmacokinetics of Rifaximin in patients with impaired renal function has not been studied.
Hepatic Impairment: The systemic exposure of Rifaximin was markedly elevated in patients with hepatic impairment compared to healthy subjects.
","No specific information is available on the treatment of over dosage with Rifaximin. In case of over dosage, discontinue Rifaximin, treat symptomatically and institute supportive measures as required.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+439,Rifampicin + Isoniazid + Pyrazinamide + Ethambutol,rifampicin-isoniazid-pyrazinamide-ethambutol-439,,Combined anti- Tubercular Preparations,Tuberculosis,"Treatment of both pulmonary and extrapulmonary tuberculosis in the intensive initial phase of treatment.
","Combined anti- Tubercular Preparations
","Rifampicin: It is a semisynthetic derivative of rifamycin, suppresses bacterial RNA synthesis by binding to the β-subunit of DNA-dependent RNA polymerase, thus inhibiting the attachment of the enzyme to DNA, blocking RNA transcription and elongation. It does not inhibit the counterpart mammalian enzyme.
Rifampicin has a bactericidal action and a potent sterilizing effect against both intracellular and extracellular tubercle bacilli. Cross-resistance has been shown only with other rifamycin derivatives.
Isoniazid: It kills actively growing tubercle bacilli by inhibiting the biosynthesis of mycolic acids, which are the major components of the bacterial cell wall of Mycobacterium tuberculosis.
Pyrazinamide: Pyrazinamide, an antituberculous drug, is the pyrazine analog of nicotinamide. The precise mechanism of action of pyrazinamide is not known. Its metabolite, pyrazinoic acid, which is less active in vitro may possibly be involved in the in vivo activity of pyrazinamide.
Ethambutol: Ethambutol diffuses slowly into actively growing Mycobacteria cells eg, tubercle bacilli. It inhibits the synthesis of 1 or more metabolites, thus causing impaired cell metabolism, arrest cell multiplication and induce cell death. No cross-resistance with other agents has been demonstrated.
Spectrum of Activity: Rifampicin, isoniazid, pyrazinamide, and ethambutol, at therapeutic levels, have demonstrated bactericidal activity against both intracellular and extracellular Mycobacterium tuberculosis organism.
","Adults: 3 tablets/day for an average body weight of 50 kg.
Patients weighing-
+
+- >70 kg: 5 tablets
+- 55-70 kg: 4 tablets
+- 38-54 kg: 3 tablets
+- 30-37 kg: 2 tablets
+
+All doses to be taken once daily for 2 months on intensive phase.
",,"Rifampicin: Induces microsomal enzymes (accelerates clearance of methadone, oral anticoagulants, glucocorticoids, oestrogen, oral hypoglycaemic agents, digitoxin, antiarrhythmics, theophylline, anticonvulsants, azole antifungal, cyclosporin).
Isoniazid: Inhibits metabolism of antiepileptics, benzodiazepines, warfarin, theophylline. Increases metabolism of enflurane. Alcohol, ASA, Al-containing antacids, corticosteroids, ketoconazole, propranolol.
Pyrazinamide: Decreases efficacy of gout therapy agents.
Ethambutol: Neurotoxic agents.
","Hypersensitivity to rifampicin, isoniazid, pyrazinamide or ethambutol.
Isoniazid: Previous isoniazid-associated hepatic injury; severe adverse reactions to isoniazid eg, fever, chills and arthritis; acute liver disease of any etiology, a history of previous hypersensitivity reaction to isoniazid including drug-induced hepatitis.
","Rifampicin: Reddish discolouration of body fluids, asymptomatic increase in liver enzymes, elevations of BUN & uric acid, hemolysis, hematuria, intestinal nephritis, renal insufficiency, Gl discomfort, CNS effects, hematological changes, skin rash, endocrine effects.
Isoniazid: Disturbances of liver function, hepatitis, Gl disturbances, peripheral neuropathy, dizziness, lightheadedness, hematological changes, allergic reactions.
Pyrazinamide: Transient rise in serum transaminases, hepatotoxicity, hepatomegaly, jaundice, hyperuricemia, intestinal nephritis, dysuria, Gl disturbances, hematological changes, allergic reactions.
Ethambutol: Confusion, disorientation, headache, visual disturbances, jaundice, transient liver dysfunction, Gl disturbances, hematological changes, allergic effects, acute gout (rare).
","Rifampicin: Since rifampicin has been reported to cross the placental barrier and appear in cord blood and in maternal milk, neonates and newborns of rifampicin-treated mothers should be carefully observed for any evidence of untoward effects.
Ethambutol: While administration of ethambutol to pregnant human patients has produced no detectable effect upon the fetus, the possible teratogenic potential in women capable of bearing children would be weighed carefully against the benefits of therapy. There are published reports of 5 women who received ethambutol during pregnancy without apparent adverse effect upon the fetus.
","Impaired renal or liver function, DM, chronic alcoholism, undernourishment, history of gout, patients with convulsive disorders, acute porphyria. Elderly. Pregnancy & lactation. Perform periodic blood counts & liver function tests. Avoid use with soft contact lenses.
Children <8 year or patients who are not able to communicate visual disturbances. Check visual ability before starting treatment & monitor during treatment.
","Use in children: Ethambutol is not recommended for use in children <13 years since safe conditions for use have not been established.
",,,,"Store at temperatures not exceeding 30°C.
",11
+635,Rifampicin + Isoniazid + Pyrazinamide,rifampicin-isoniazid-pyrazinamide-635,https://medex.com.bd/attachments/UUDidzUxs2DdKm1NBRkizLHicjeOUZ/rifampicin-isoniazid-pyrazinamide-prescribing-information,Combined anti- Tubercular Preparations,Tuberculosis,"Rifampin, isoniazid, and pyrazinamide is indicated in the initial phase of the short-course treatment of pulmonary tuberculosis. During this phase, which should last 2 months, this drug should be administered on a daily, continuous basis.
Following the initial phase and treatment ... Read more
Rifampin, isoniazid, and pyrazinamide is indicated in the initial phase of the short-course treatment of pulmonary tuberculosis. During this phase, which should last 2 months, this drug should be administered on a daily, continuous basis.
Following the initial phase and treatment with this drug, treatment should be continued with rifampin and isoniazid for at least 4 months. Treatment should be continued for a longer period of time if the patient is still sputum or culture positive, if resistant organisms are present, or if the patient is HIV positive.
In the treatment of tuberculosis, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. Bacteriologic smears or cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin, isoniazid, and pyrazinamide and they should be repeated throughout therapy to monitor response to the treatment. If test results show resistance to any of the components of this drug and the patient is not responding to therapy, the drug regimen should be modified.
","Combined anti- Tubercular Preparations
","Rifampicin, isoniazid and pyrazinamide are all active bactericidal antituberculosis drugs. Rifampicin and isoniazid are particularly active against the rapidly growing extracellular organisms and have an intracellular bactericidal activity. Rifampicin also inhibits DNA-dependent RNA polymerase activity in susceptible cells and it has activity against slow and intermittently-growing M tuberculosis. Pyrazinamide, particularly in the acid pH environment of macrophages is active against intracellular organisms. Combination of these agents covers activity against the 3 different bacterial populations.
","Total Dosage Requirement:
+
+- Rifampicin: 10 (8-12) mg/kg body mass/day.
+- Isoniazid: 5 (4-6) mg/kg body mass/day.
+- Pyrazinamide: 25 (20-30) mg/kg body mass/day.
+
+
Pediatric Patients: The ratio of the drugs may not be appropriate in pediatric patients under the age of 15 (e.g., higher mg/kg doses of isoniazid are usually given in pediatric patients than adults).
The tablets should be given as a single dose, preferably on an empty stomach, at least 30 min before breakfast to ensure a high peak serum concentration.
Tablets are recommended in the initial intensive phase of the short course treatment of tuberculosis. During this phase which lasts for 2 months
",,"Rifampicin may reduce effectivity of hormonal contraceptives, ACE inhibitors (e.g. enalapril, imidapril), antiemetics (e.g. aprepitant), antineoplastics (e.g. imatinib), diuretics (e.g. eplerenone), drugs for erectile dysfunction (e.g. tadalafil), oral hypoglycaemics (e.g. nateglinide, repaglinide), NSAIDs (e.g. etoricoxib). Rifampicin may reduce serum levels of atovaquone, ketoconazole. Antacids may reduce absorption of rifampicin. Anaesthetics and halothane may increase risk for hepatotoxicity with rifampicin and isoniazid.
Isoniazid may increase serum levels of phenytoin and theophylline; and may decrease carbamazepine metabolism. Stavudine may increase risk of distal sensory neuropathy with isoniazid. Antacids may reduce isoniazid absorption. May increase plasma levels of isoniazid with para-aminosalicylic acid. Increased risk of CNS toxicity when isoniazid is used concomitantly with cycloserine.
Pyrazinamide antagonizes the effects of probenecid and sulfinpyrazone.
Potentially Fatal: Concominant use with saquinavir/ritonavir may increase risk of severe hepatotoxicity. May reduce antiviral efficacy of atazanavir, darunavir, fosamprenavir, saquinavir, or tipranavir
","Known or suspected hypersensitivity to rifamycins and/or to isoniazid and to pyrazinamide and/or to any of the excipients including a history of drug-induced hepatitis, acute liver diseases regardless of their origin, and peripheral neuritis.
","Unwanted effects which may occur during continuous daily or intermittent therapy: Rifampicin: Rifampicin may cause reddish discolouration of body fluids and occasionally other body secretions eg, urine, sputum, lacrimal fluid, faeces, saliva and sweat. It may permanently discolour soft contact lenses.
Hepatic Effects: Very common (>10%) is an asymptomatic increase in liver enzymes; severe life-threatening hepatic reactions eg, hepatic failure and acute fulminant hepatitis are uncommon (>0.1% and <1%). In isolated cases (<0.01 %), a fatal outcome was observed.
Renal Effects: Elevations of BUN and serum uric acid, haemolysis, haematuria, interstitial nephritis, renal insufficiency.
Gastrointestinal Effects: Nausea, abdominal pains, vomiting or diarrhoea, pseudomembranous colitis.
Central and Peripheral Nervous System Effects: Tiredness, drowsiness, headache, dizziness, ataxia, mental confusion, muscular weakness, visual disturbances.
Haematological Changes: Leucopenia, eosinophilia, thrombocytopenia and thrombocytopenic purpura.
Effects on Skin and Appendages: Flushing, itching with or without skin rash, urticaria, reddening of the eyes, exudative conjunctivitis or generalised hypersensitivity reactions involving the skin eg, exfoliative dermatitis, Lyell's syndrome and pemphigoid reactions.
Endocrine Effects: Disturbances in the menstrual cycle, induction of crisis in Addison patients.
Unwanted effects chiefly occurring during intermittent therapy or upon resumption of treatment after temporary interruption
","Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","Caution is advised in patients with impaired renal or liver function, diabetes mellitus, chronic alcoholism and undernourished patients, patients with a history of gout and patients suffering from convulsive disorders and acute porphyria. Precautions need to be taken: Blood counts and liver function tests (SGPT, SGOT) should be performed periodically (especially in prolonged treatment) and at baseline, if possible.
Patients with current chronic liver disease or impaired liver function should be treated with caution and under strict medical supervision. Careful monitoring of liver function should be carried out and attention should be paid to possible prodromal symptoms of hepatitis eg, fatigue, weakness, malaise, anorexia, nausea or vomiting. If these symptoms appear or if signs suggestive of hepatic damage are detected, treatment should be discontinued promptly. The occurrence of severe and sometimes fatal hepatitis associated may develop even after many months of treatment.
",,,,,"Should be stored in cool and dry place
",10
+636,Rifampicin + Isoniazid,rifampicin-isoniazid-636,https://medex.com.bd/attachments/IxhSKssSrt1akKMhd0Ccz5D6vmCwxg/rifampicin-isoniazid-prescribing-information,Combined anti- Tubercular Preparations,Tuberculosis,"Rifampicin and Isoniazid belongs to a group of medicines called antituberculosis agents. It is a fixed combination of two very effective antituberculosis agents which stop the growth of mycobacteria. These mycobacteria cause tuberculosis. Rifampicin and Isoniazid is used for the continuation phase treatment of tuberculosis.
","Combined anti- Tubercular Preparations
","Rifampicin and isoniazid are active bactericidal anti-TB drugs which are particularly active against the rapidly growing extracellular organisms and also have bactericidal activity intracellularly. Rifampicin inhibits DNA-dependent RNA polymerase activity in susceptible cells. Specifically, it interacts with bacterial RNA polymerase but does not inhibit the mammalian enzyme. Cross-resistance to rifampicin has only been shown with other rifamycins. It has activity against slow-and intermittently-growing M. tuberculosis. Isoniazid acts against actively growing tubercle bacilli.
","Body weight <50 kg: 3 tablet of 150/100 once daily or 1 tablet of 450/300 once daily
Body weight >50 kg: 2 tablet of 300/150 once daily.
Hepatic impairment: Max: 8 mg/kg daily.
",,"May reduce effectivity of hormonal contraceptives. Reduced absorption with antacids. May decrease plasma concentrations of antivirals (e.g. atazanavir, darunavir, fosamprenavir), atovaquone with rifampicin. Rifampicin may reduce serum levels of anticonvulsants (e.g. phenytoin), antiarrhythmics (e.g. disopyramide), oral anticoagulants, antifungals (e.g. ketoconazole), barbiturates, ?-blockers, Ca channel blockers (e.g. diltiazem), chloramphenicol, clarithromycin, corticosteroids, ciclosporin, cardiac glycosides, clofibrate, dapsone, diazepam, doxycycline, fluoroquinolones (e.g. ciprofloxacin), haloperidol, oral hypoglycemic agents (sulfonylureas), levothyroxine, methadone, narcotic analgesics, progestins, quinine, tacrolimus, theophylline, TCAs (e.g. amitriptyline, nortriptyline) and zidovudine. Increased risk of hepatotoxicity with halothane.
Isoniazid may inhibit the metabolism of anticonvulsants (e.g. carbamazepine, phenytoin), benzodiazepines (e.g. diazepam), haloperidol, ketoconazole, theophylline, and warfarin. May enhance the CNS effects of meperidine, cycloserine, and disulfiram with isoniazid. Loss of glucose control in patients on oral hypoglycaemics with isoniazid.
","Known or suspected hypersensitivity to rifamycins and/or to INH, and/or to any of the excipients including a history of drug-induced hepatitis; acute liver diseases, regardless of their origin; peripheral neuritis.
","Unwanted effects which may occur during continuous daily or intermittent therapy: Rifampicin: Rifampicin may cause reddish discolouration of body fluids and occasionally other body secretions eg, urine, sputum, lacrimal fluid, faeces, saliva and sweat. It may permanently discolour soft contact lenses.
Hepatic Effects: Very common (>10%) is an asymptomatic increase in liver enzymes; severe life-threatening hepatic reactions eg, hepatic failure and acute fulminant hepatitis are uncommon (>0.1% and <1%). In isolated cases (<0.01 %), a fatal outcome was observed.
Renal Effects: Elevations of BUN and serum uric acid, haemolysis, haematuria, interstitial nephritis, renal insufficiency. Gastrointestinal Effects: Nausea, abdominal pains, vomiting or diarrhoea, pseudomembranous colitis.
Central and Peripheral Nervous System Effects: Tiredness, drowsiness, headache, dizziness, ataxia, mental confusion, muscular weakness, visual disturbances. Haematological Changes: Leucopenia, eosinophilia, thrombocytopenia and thrombocytopenic purpura. Effects on Skin and Appendages: Flushing, itching with or without skin rash, urticaria, reddening of the eyes, exudative conjunctivitis or generalised hypersensitivity reactions involving the skin eg, exfoliative dermatitis, Lyell's syndrome and pemphigoid reactions. Endocrine Effects: Disturbances in the menstrual cycle, induction of crisis in Addison patients. Unwanted effects chiefly occurring during intermittent therapy or upon resumption of treatment after temporary interruption
","Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","Use of isoniazid should be carefully monitored in the following:
+
+- Daily users of alcohol. Daily ingestion of alcohol may be associated with a higher incidence of isoniazid hepatitis.
+- Patients with active chronic liver disease or severe renal dysfunction.
+- Age >35.
+- Concurrent use of any chronically administered medication.
+- History of previous discontinuation of isoniazid.
+- Existence of peripheral neuropathy or conditions predisposing to neuropathy. Pregnancy.
+- Injection drug use.
+- Women belonging to minority groups, particularly in the post-partum period.
+- HIV seropositive patients.
+
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+956,Rifampicin,rifampicin-956,https://medex.com.bd/attachments/loFuaXIyiRSqHkl2rt652n8UzvLNet/rifampicin-prescribing-information,Anti-Tubercular Antibiotics,Tuberculosis,"In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the ... Read more
In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampinand they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.
","Anti-Tubercular Antibiotics
","Rifampicin suppresses initiation of chain formation for RNA synthesis in susceptible bacteria by binding to the β subunit of DNA-dependent RNA polymerase, thus blocking RNA transcription.
","Rifampin can be administered by the oral route or by IV infusion. IV doses are the same as those for oral.
Tuberculosis:
+
+- Adults: 10 mg/kg, in a single daily administration, not to exceed 600 mg/day, oral or IV
+- Pediatric Patients: 10–20 mg/kg, not to exceed 600 mg/day, oral or IV
+
+It is recommended that oral rifampin be administered once daily, either 1 hour before or 2 hours after a meal with a full glass of water.
Rifampin is indicated in the treatment of all forms of tuberculosis. A three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide is recommended in the initial phase of shortcourse therapy which is usually continued for 2 months. The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and the Centers for Disease Control and Prevention recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin and pyrazinamide for initial treatment of tuberculosis unless the likelihood of INH resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered.
Following the initial phase, treatment should be continued with rifampin and isoniazid for at least 4 months. Treatment should be continued for longer if the patient is still sputum or culture positive, if resistant organisms are present, or if the patient is HIV positive.
","Should be taken on an empty stomach. Best taken on an empty stomach 1 hr before or 2 hr after meals.
","May accelerate the metabolism and reduce the effect of drugs that are metabolised by CYP450 enzymes (e.g. quinidine, phenytoin, theophylline). Decreased concentrations of atovaquone and increased concentrations of rifampicin when taken concomitantly. Concurrent use of ketoconazole and rifampicin may result in decreased serum concentrations of both drugs. May decrease serum concentrations of enalaprilat. Reduced absorption by antacids. Increased risk of hepatotoxicity with halothane or isoniazid.
","Rifampicin is contraindicated in patients with a history of hypersensitivity to rifampin or any of the components, or to any of the rifamycins. Rifampin is contraindicated in patients who are also receiving ritonavir-boosted saquinavir due to an increased risk of severe hepatocellular toxicity.
Rifampin is contraindicated in patients who are also receiving atazanavir, darunavir, fosamprenavir, saquinavir, or tipranavir due to the potential of rifampin to substantially decrease plasma concentrations of these antiviral drugs, which may result in loss of antiviral efficacy and/or development of viral resistance.
","Facial flushing and itching, with or without a rash, flu-like syndrome characterised by episodes of fever, chills, headache, dizziness, bone pain, shortness of breath, and malaise; GI adverse effects (e.g. nausea, vomiting, anorexia, diarrhoea, epigastric distress), pseudomembranous colitis, eosinophilia, leucopenia, haemolytic anaemia; alterations in kidney function and renal failure, menstrual disturbances, oedema, myopathy, muscular weakness; orange-red discolouration of the urine, faeces, sweat, saliva, sputum, tears, and other body fluids; thrombophlebitis, local irritation and inflammation after prolonged IV infusion. Rarely, eye irritation and visual disturbances, anaphylaxis or shock.
","Pregnancy: When administered during the last few weeks of pregnancy, rifampin can cause post natal hemorrhages in the mother and infant for which treatment with vitamin K may be indicated.
Nursing Mothers: Because of the potential for tumorigenicity shown for rifampin in animal studies, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
","Rifampicin has been shown to produce liver dysfunction. Fatalities associated with jaundice have occurred in patients with liver disease and in patients taking rifampin with other hepatotoxic agents. Patients with impaired liver function should be given rifampin only in cases of necessity and then with caution and under strict medical supervision. In these patients, careful monitoring of liver function, especially SGPT/ALT and SGOT/AST should be carried out prior to therapy and then every 2 to 4 weeks during therapy. If signs of hepatocellular damage occur, rifampin should be withdrawn.
In some cases, hyperbilirubinemia resulting from competition between rifampin and bilirubin for excretory pathways of the liver at the cell level can occur in the early days of treatment. An isolated report showing a moderate rise in bilirubin and/or transaminase level is not in itself an indication for interrupting treatment; rather, the decision should be made after repeating the tests, noting trends in the levels, and considering them in conjunction with the patient's clinical condition.
Rifampin has enzyme-inducing properties, including induction of delta amino levulinic acid synthetase. Isolated reports have associated porphyria exacerbation with rifampin administration.
","Geriatric Use: Clinical studies of Rifampicin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Caution should therefore be observed in using rifampin in elderly patients.
","Nausea, vomiting, abdominal pain, pruritus, headache, and increasing lethargy will probably occur within a short time after ingestion; unconsciousness may occur when there is severe hepatic disease. Transient increases in liver enzymes and/or bilirubin may occur. Brownish-red or orange discoloration of the skin, urine, sweat, saliva, tears, and feces will occur, and its intensity is proportional to the amount ingested.
Liver enlargement, possibly with tenderness, can develop within a few hours after severe overdosage; bilirubin levels may increase and jaundice may develop rapidly. Hepatic involvement may be more marked in patients with prior impairment of hepatic function. Other physical findings remain essentially normal. A direct effect upon the hematopoietic system, electrolyte levels, or acid-base balance is unlikely.
Facial or periorbital edema has also been reported in pediatric patients. Hypotension, sinus tachycardia, ventricular arrhythmias, seizures and cardiac arrest were reported in some fatal cases.
",,"Preparation Of Solution For IV Infusion: Reconstitute the lyophilized powder by transferring 10 mL of sterile water for injection to a vial containing 600 mg of rifampin for injection. Swirl vial gently to completely dissolve the antibiotic. The reconstituted solution contains 60 mg rifampin per mL and is stable at room temperature for up to 30 hours. Prior to administration, withdraw from the reconstituted solution a volume equivalent to the amount of rifampin calculated to be administered and add to 500 mL of infusion medium. Mix well and infuse at a rate allowing for complete infusion within 3 hours. Alternatively, the amount of rifampin calculated to be administered may be added to 100 mL of infusion medium and infused in 30 minutes.
Dilutions in dextrose 5% for injection (D5W) are stable at room temperature for up to 8 hours and should be prepared and used within this time. Precipitation of rifampin from the infusion solution may occur beyond this time. Dilutions in normal saline are stable at room temperature for up to 6 hours and should be prepared and used within this time. Other infusion solutions are not recommended.
","Store between 15-30° C. Avoid excessive heat and protect from light.
",14
+955,Riboflavin,riboflavin-955,,Vitamin-B preparations,Thiamine and riboflavin deficiency,"To prevent and to treat deficiencies of vitamin B2 such as cheilosis, angular stomatitis, glossitis, keratitis, seborrhoeic dermatitis.
","Vitamin-B preparations
","Riboflavin or vitamin B2 is an easily absorbed, water-soluble micronutrient with a key role in maintaining human health. Like the other B vitamins, it supports energy production by aiding in the metabolising of fats, carbohydrates, and proteins. Vitamin B2 is also required for red blood cell formation and respiration, antibody production, and for regulating human growth and reproduction. It is essential for healthy skin, nails, hair growth and general good health, including regulating thyroid activity. Riboflavin also helps in the prevention or treatment of many types of eye disorders, including some cases of cataracts.
Binds to riboflavin hydrogenase, riboflavin kinase, and riboflavin synthase. Riboflavin is the precursor of flavin mononucleotide (FMN, riboflavin monophosphate) and flavin adenine dinucleotide (FAD). The antioxidant activity of riboflavin is principally derived from its role as a precursor of FAD and the role of this cofactor in the production of the antioxidant reduced glutathione. Reduced glutathione is the cofactor of the selenium-containing glutathione peroxidases among other things. The glutathione peroxidases are major antioxidant enzymes. Reduced glutathione is generated by the FAD-containing enzyme glutathione reductase.
","For treating low levels of riboflavin (riboflavin deficiency) in adults: 5-30 mg of riboflavin daily in divided doses.
For preventing migraine headaches: 400 mg of riboflavin (Vitamin B2) per day. It may take up to three months to get best results.
For preventing cataracts: approximately 2.6 mg of riboflavin (Vitamin B2)
",,"Drying medications (Anticholinergic drugs), Medications for depression (Tricyclic antidepressants), Phenobarbital, Probenecid.
","Hypersensitivity to Riboflavin.
","Riboflavin is likely safe for most people. In some people, Riboflavin can cause the urine to turn a yellow- orange color. When taken in high doses, Riboflavin might cause diarrhea, an increase in urine, and other side effects.
","Riboflavin is likely safe for pregnant or breastfeeding women when taken in the amounts recommended.
","Riboflavin is non-toxic. No warnings or precautions have been established .
",,,,,"Store at a cool and dry place. Protect from light.
",10
+1049,Salmeterol + Fluticasone Propionate,salmeterol-fluticasone-propionate-1049,https://medex.com.bd/attachments/QPhAfzbm259OXxI4EGmELxysNPjeTC/salmeterol-fluticasone-propionate-glaxosmithkline-prescribing-information,Long-acting selective β-adrenoceptor stimulants,COPD,"This is indicated in the regular treatment of asthma where use of a combination product (long-acting β2-agonist and inhaled corticosteroid) is appropriate:
+
+- patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting β2-agonist or
+- patients already adequately controlled on both inhaled corticosteroid and long-acting β2-agonist.
+
","Long-acting selective β-adrenoceptor stimulants, Respiratory corticosteroids
","Salmeterol Xinafoate is a selective, long acting beta-2 agonist used in the treatment of asthma and other forms of diffuse airways obstruction. Fluticasone Propionate is a corticosteroid with mainly glucocorticoid activity. Fluticasone Propionate is stated to exert a topical effect on the lungs without systematic effects at usual dose.
Salmeterol protects against symptoms, Fluticasone Propionate improves lung function and prevents exacerbations of the condition. This preparation can offer a more convenient regime for patients on concurrent β-agonist and inhaled corticosteroid therapy. The respective mechanisms of action of both drugs are discussed below:
Salmeterol: Salmeterol is a selective long-acting (12 hour) beta-2-adrenoceptor agonist with a long side chain which binds to the exo-site of the receptor.
Fluticasone Propionate: Fluticasone Propionate given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbaions of asthma, without the adverse effects observed when corticosteroids are administered systemically.
","Inhalation Aerosol:
+
+- Adults and adolescents 12 years and older: 2 puffs of 25 µg Salmeterol and 50 µg Fluticasone Propionate twice daily or 2 puffs of 25 µg Salmeterol and 125 µg Fluticasone Propionate twice daily or 2 puffs of 25 µg Salmeterol and 250 µg Fluticasone Propionate twice daily.
+- Children (4-12 years): 2 puffs of 25 µg salmeterol and 50 µg Fluticasone Propionate twice daily.
+
+
Inhalation Powder in Capsule (For Asthma):
+
+- Adult and Adolescent (12 Years and Older): Salmeterol 50 µg & Fluticasone 100 µg or Salmeterol 50 µg & Fluticasone 250 µg twice daily (morning and evening, approximately 12 hours apart).
+- The recommended starting dosages for Salmeterol 50 µg & Fluticasone 100 µg & Salmeterol 50 µg & Fluticasone 250 µg for patients aged 12 years and older are based upon patients asthma severity.
+- The maximum recommended dosage is Salmeterol 50 µg & Fluticasone 500 µg twice daily.
+- Pediatric Patients (4 to 11 Years): For patients with asthma who are not controlled on an inhaled corticosteroid, the dosage is Salmeterol 50 µg & Fluticasone 100 µg twice daily (morning and evening, approximately 12 hours apart).
+
+
Inhalation Powder in Capsule (For COPD): Salmeterol 50 µg & Fluticasone 250 µg twice daily (morning and evening, approximately 12 hours apart). Rinsing the mouth after each inhalation is advised.
Inhalation Powder in Maxhaler (For Asthma): This is a moulded plastic device containing a foil strip with 60 regularly placed blisters containing pre-dispensed inhalation powder. Patients should be made aware that Maxhaler must be used daily for optimum benefit, even when asymptomatic.
Adults and Adolescents (12 years and older)-
+
+- 50/100 Maxhaler: One Inhalation twice daily
+- 50/250 Maxhaler: One Inhalation twice daily
+- 50/500 Maxhaler: One Inhalation twice daily
+
+Children (4 years and older)-
+
+- 50/100 Maxhaler: One Inhalation twice daily. The maximum licensed dose of fluticasone propionate delivered by this Maxhaler in children is 100 ug twice daily. There are no data available for use of this Maxhaler in children aged under 4 years.
+
+
Inhalation Powder in Maxhaler (For COPD):
+
+- Maxhaler: One Inhalation twice daily
+- Special patient groups: There is no need to adjust the dose in elderly patients or in those with renal impairment. There are no data available for use of this in patients with hepatic impairment.
+- Using the Maxhaler: This is a patient friendly, ready to use and easy to grip device. Use as per instructions for use.
+
","Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.
Following simple steps can help to use Inhaler effectively (According to ""
National Asthma Guidelines for Medical Practitioners"" published by Asthma Association):
+
+- Take off the cap.
+- Shake the inhaler (at least six times) vigorously before each use.
+- If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
+- Breathe out as full as comfortably possible & hold the inhaler upright.
+- Place the actuator into mouth between the teeth and close lips around the mouthpiece.
+- While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
+- Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
+- If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
+- After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
+- Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.
+
+
Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.
","Both non-selective and selective β-blockers should be avoided in patients with asthma, unless there are compelling reasons for their use. Due to the very low plasma concentrations achieved after inhaled dosing clinically significant drug interactions are unlikely. Care should be taken when co-administering known strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir), as there is potential for increased systemic exposure to Fluticasone Propionate.
","This is contraindicated in patients with a history of hypersensitivity to any of the ingredients.
","As this preparation contains Salmeterol and Fluticasone Propionate, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following concurrent administration of the two compounds. Adverse events, which have been associated with Salmeterol or Fluticasone Propionate, are given below.
Salmeterol: The pharmacological side effects of beta-2-agonist treatment, such as tremor, subjective palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy. Cardiac arrhythmia (including atrial fibrillation, supraventricular tachycardia and extra systoles) may occur, usually in susceptible patients. There have been reports of arthralgia and hypersensitivity reactions, including rash, oedema and angioedema. There have been reports of oropharyngeal irritation. There have been rare reports of muscle cramps.
Fluticasone propionate: Hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Cutaneous hypersensitivity reactions have been reported. Rare cases of facial and oropharyngeal oedema have been reported. Both hoarseness and incidence of candidiasis may be relieved by gargling with water after use of Salmeterol/ Fluticasone Propionate Inhaler.
","Administration of drugs during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus or child. There is insufficient experience of the use of Salmeterol Xinafoate and Fluticasone Propionate in human pregnancy and lactation. There are no data available for human breast milk.
","Consideration should be given to additional corticosteroid therapies, and to including administration of antibiotics if an infection is present. As with all inhaled medication containing corticosteroids, this preparation should be administered with caution in patients with active or quiescent pulmonary tuberculosis. This preparation should be administered with caution in patients with thyrotoxicosis.
","Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to paediatric patients. The long-term effects of this reduction including the impact of final adult height are unknown.
",,,,"Pressurised canister, do not puncture, break or incinerate even when apparently empty. Avoid storage in direct sunlight or heat. Store below 30°C. Keep away from eyes. Keep away from children.
",12
+1045,Salicylic Acid + Lactic Acid,salicylic-acid-lactic-acid-1045,,Combined preparations,Warts,"This is a topical solution indicated in the treatment of warts, corns and calluses.
Information For Patients
+
+- Warts: A wart is a viral infection of the surface layers of the skin. The incubation period varies from a few weeks to several months. Warts can spread by direct contact with a wart to damaged skin.
... Read more
This is a topical solution indicated in the treatment of warts, corns and calluses.
Information For Patients
+
+- Warts: A wart is a viral infection of the surface layers of the skin. The incubation period varies from a few weeks to several months. Warts can spread by direct contact with a wart to damaged skin.
+- Corns: A corn is a small, hardened area of skin which often looks yellow compared to the surrounding skin. It is typically round or cone-shaped, pointing down into the skin. Corns most often form on the feet and sometimes on the hands and are caused by constant or repeated friction or pressure.
+- Calluses: A callus is rough, thickened skin spread over a wide area. Like a corn, it is caused by constant or repeated friction or pressure, but unlike corns, calluses are flat and have normal skin markings.
+
","Combined preparations
","Salicylic acid is a widely used and effective keratolytic, it produces desquamation and destruction of the epithelium by solubilising the intercellular cement of the Stratum Corneum. Lactic acid affects the keratinisation process, reducing hyperkeratosis and is also caustic, leading to the destruction of hyperkeratotic tissue. Collodion is derived from cellulose in a base containing ethanol and ether. It allows easy and accurate application of the product and dries to leave a film which hydrates the tissue and facilitates penetration of the active ingredients.
","Unscrew bottle cap and with the help of brush applicator, apply to the affected areas. ‘Before starting to use this topical solution, unscrew the fitted cap, discard it. Carefully remove the plug away from your body to avoid splashing into eyes/ face and discard it, replace with the brush applicator cap provided in
the sealed polybag given in the carton. This topical solution should be applied to the affected areas once daily, according to the following instructions:
+
+- Soak affected site in hot water for five minutes.
+- Rub surface carefully with pumice stone or emeryboard to remove any hard skin. Dry with your own towel.
+- Apply this topical solution using the brush applicator supplied, taking care to avoid contact with normal skin.
+- Allow to dry thoroughly and cover with plaster if lesion is large or on the foot to help penetration of active ingredients.
+- Continue treatment once daily until the lesion is completely cleared and the ridge lines of the skin have been restored or when the corn can be removed.
+- The usual treatment period is 6 to 12 weeks.
+
",,"There are no known drug interactions and none well documented.
","Not for prolonged use in high concentrations and on large areas of the body. Impaired peripheral circulation or diabetes. Avoid broken skin, mouth, eyes, mucous membranes and anogenital region.
","Stinging, burning, or irritation of the skin,Itching, prolonged use over a large skin area may cause salicylate toxicity, ringing sound in the ears (tinnitus), Diarrhoea, Vomiting.
","Pregnancy Category- Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
","This preparation is formulated for the controlled corrosion of keratin and thus care should be taken to apply the product to the affected area only. Do not use on the face or anogenital regions or if you are diabetic or have impaired circulation. Do not use on moles, birthmarks or unusual skin growths. Do not treat warts over large areas at one time, or use on infants and very young children unless on medical advice. For External Use Only
",,"Excessive topical use may result in burning, particularly of normal skin. Following excessive topical use, apply emollients as required. Following ingestion, administer copious quantities of water and antacids as required. Ingestion may cause nausea, vomiting and abdominal pain.
",,,"In view of its high inflammability, it is recommended that Salicylic Acid & Lactic Acid be stored in a cool place not exceeding 25°C. Keep away from naked flame. Keep out of reach of children. Since this topical solution is volatile, close the bottle tightly after each use.
",11
+974,Salicylic Acid,salicylic-acid-974,https://medex.com.bd/attachments/8LoL05LGf9jTIVygWl4Istf5zKvyl6/salicylic-acid-prescribing-information,Topical salicylic preparation,Warts,"6% Salicylic Acid: This topical preparations treat the following common scaly conditions:
+
+- Chronic atopic dermatitis
+- Lichen simplex
+- Psoriasis
+- Seborrhoeic dermatitis
+- Ichthiosis
+
+
12% Salicylic Acid:
... Read more 6% Salicylic Acid: This topical preparations treat the following common scaly conditions:
+
+- Chronic atopic dermatitis
+- Lichen simplex
+- Psoriasis
+- Seborrhoeic dermatitis
+- Ichthiosis
+
+
12% Salicylic Acid: This topical preparations treat the following common scaly conditions:
+
+- Warts (small excessive growths of skin caused by a type of virus. Warts often occur on the fingers or on the back of the hands).
+- Verruca (occurs only on the sole of the feet and can be painful. It often looks like a small white ring of skin with a black dot in the centre).
+- Corns and Calluses (are hard, thick pads of skin caused by pressure and friction. They usually occur on the feet due to poorly fitting shoes and can occur on the hands).
+
+
2% Salicylic Acid: This topical preparation is indicated in-
+
+- Mild to moderate acne
+- Blackheads and whiteheads
+- Redness & swelling of face
+- Pimples
+- To prevent future acne breakouts
+
","Topical salicylic preparation
","Salicylic Acid has a potent keratolytic & a slight antiseptic action when applied topically to the skin. In low concentrations, the drug has keratoplastic activity (correction of abnormal keratinization) & in higher concentrations, the drug has keratolytic activity (causes peeling of skin). Salicylic Acid softens & destroys the stratum corneum by increasing endogenous hydration (water concentration), probably because of decreased pH, which causes the cornified epithelium (horny layer of the skin) to swell, soften, & then desquamate. Necrosis of normal skin has been associated with overuse of the drug. At high concentrations, Salicylic Acid has a caustic effect. Moisture is essential for Salicylic Acid to exert its action on the skin and for maceration and desquamation of epidermal tissue to occur. The drug has weak antifungal & antibacterial activity.
","6% & 12% Salicylic Acid: Apply to affected area once daily. Hydrate area for 5 minutes prior to application if possible. Occlude the area at night. Wash off in morning. Salicylic Acid is used in children over 2 years.
2% Salicylic Acid: Apply enough medicine to cover the affected area once daily in 1st week then 2 to 3 times daily from 2nd week and rub gently. After 3-5 minutes rinse face with cool water. Salicylic Acid is used in children over 2 years.
",,"Do not use other topical preparations on the treated area unless otherwise directed by your healthcare provider. They may interfere with treatment or increase skin irritation.
","It should not be used in any patient known to be sensitive to Salicylic Acid or any other listed ingredients.
","An allergic reaction (shortness of breath, closing of the throat, swelling of the lips, face or tongue or hives) or severe skin irritation.
","Pregnancy Category C. If used by nursing mothers, it should not be used on the chest area to avoid accidental contamination of the child.
","For external use only. Avoid contact with eyes and other mucous membranes.
",,"An overdose of Salicylic Acid topical is unlikely to occur. If the medication has been ingested or an overdose is suspected, the patient needs to be hospitalized immediately.
",,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",11
+625,Salbutamol + Ipratropium (Solution for inhalation),salbutamol-ipratropium-solution-for-inhalation-625,,Combined bronchodilators,COPD,"Salbutamol sulfate & Ipratropium bromide solution for inhalation is indicated for the treatment of reversible bronchospasm associated with obstructive airway diseases in patients who require more than a single bronchodilator.
","Combined bronchodilators
","Ipratropium Bromide is quickly absorbed after inhalation. The systemic bioavailability following inhalation is estimated to be less than 10% of the dose. Renal excretion of Ipratropium Bromide is given as 46% of the dose after intravenous administration. The half-life of the terminal elimination phase is about 1.6 hours as determined after intravenous administration. Elimination half-life of drug and metabolites is 3.6 hours as determined after radio labelling. Ipratropium Bromide does not penetrate the blood brain barrier.
Salbutamoi Sulphate is rapidly and completely absorbed following administration either by inhaled or oral route. Peak plasma Salbutamoi concentrations are seen within three hours of administration and it is excreted unchanged in the urine after 24 hours. The elimination half-life is 4 hours. Salbutamoi will cross the blood brain barrier reaching concentrations amounting to about five percent of the plasma concentrations.
It has been shown that co-nebulisation of Ipratropium Bromide and Salbutamoi Sulphate does not potentiate the systemic absorption of either component and that therefore the additive activity of this solution is due to the combined local effect on the lung following inhalation.
","Salbutamol sulfate & Ipratropium bromide solution for inhalation in ampoule may be administered from a suitable nebulizer or an intermittent positive pressure ventilator.
+
+- Adults (including elderly): Use one 3 ml ampoule in the nebulizer four times a day. Two additional treatments may be used per day, if needed.
+- Children: Use and dose must be determined by doctor.
+
+Patients should be advised to consult a doctor or the nearest hospital immediately in the case of acute or rapidly worsening dyspnoea if additional inhalations do not produce an adequate improvement.
","Step 1: Twist off the top of the ampoule. Be careful to hold the ampoule upright.
Step 2: Squeeze the desired amount of the nebulizer solution into the nebulizer chamber.
Step 3: If dilution is needed follow the physician’s direction.
","The concurrent administration of other beta-mimetics, systemically absorbed anticholinergics and xanthine derivatives may increase the side effects.
Beta-agonist induced hypokalaemia may be increased by concomitant treatment with xanthine derivatives, glucocorticosteroids and diuretics. This should be taken into account particularly in patients with severe airway obstruction.
Hypokalaemia may result in an increased susceptibility to arrhythmias in patients receiving digoxin. It is recommended that serum potassium levels be monitored in such situations.
A potentially serious reduction in bronchodilator effect may occur during concurrent administration of beta-blockers.
Beta-adrenergic agonists should be administered with caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, since the action of beta adrenergic agonists may be enhanced.
Inhalation of halogenated hydrocarbon anaesthetics such as halothane, trichloroethylene and enflurane may increase the susceptibility to the cardiovascular effects of beta-agonists.
","This is contraindicated in patients with hypertrophic obstructive tachyarrhythmia and in patients with a history of hypersensitivity to atropine or its derivatives, or to any other component of the product.
","In common with other beta-agonists containing products, side effects of this solution can include fine tremor of skeletal muscles and nervousness and less frequently tachycardia, dizziness, palpitations or headache, especially in hypersensitive patients.
Potentially serious hypokalaemia may result from prolonged and/or high dose beta2 agonist therapy.
As with use of other inhalation therapy, cough, local irritation and less commonly inhalation induced bronchospasm can occur. As with other beta-mimetics, nausea, vomiting, sweating, weakness and myalgia/muscle cramps may occur. In rare cases decrease in diastolic blood pressure, increase in systolic blood pressure, arrhythmias, particularly after higher doses, may occur.
In individual cases psychological alterations have been reported under inhalation therapy with beta-mimetics.
The most frequent non-respiratory anticholinergic related adverse events are dryness of mouth and dysphonia. There have been isolated reports of ocular complications (i.e. mydriasis, increased intraocular pressure, angle closure glaucoma, and eye pain) when aerosolised ipratropium bromide either alone or in combination with adrenergic beta2 agonist, has escaped into the eyes. Ocular side effects, gastrointestinal motility disturbances and urinary retention may occur in rare cases and are reversible.
","Pregnancy category C. Animal studies with Salbutamoi Sulphate have demonstrated a teratogenic effect. It is not known whether this medication is harmful to the fetus. No evidence of abnormalities has been reported in women receiving albuterol during pregnancy. This solution should be used during pregnancy only if the potential benefit justifies. This solution should be used with caution before childbirth in view of Salbutamol's inhibitory effects on uterine contractions.
Salbutamol Sulphate and Ipratropium Bromide are probably excreted in breast milk and their effects on neonates are not known. Although lipid-insoluble quaternary bases pass into breast milk, it is unlikely that this will happen to any extent especially when taken by inhalation. However, because many drugs are excreted in breast milk, caution should be exercised when This solution is administered to a nursing woman.
","In the case of acute, rapidly worsening dyspnoea a doctor should be consulted immediately. Immediate hypersensitivity reactions may occur after administration of this solution as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal oedema.
",,"The effects of overdosage are expected to be primarily related to Salbutamol because acute overdosage with Ipratropium Bromide is unlikely as it is not well absorbed systemically after inhalation or oral administration.
Symptoms: Manifestations of overdosage with salbutamol may include tachycardia, anginal pain, hypertension, hypotension , palpitations, tremor, widening of the pulse pressure, arrhythmia and flushing.
Therapy: Administration of sedatives, tranquillisers; in severe cases, intensive therapy. Beta-receptor blockers, preferably beta1-selective, are suitable as specific antidotes; however, a possible increase in bronchial obstruction must be taken into account and the dose should be adjusted carefully in patients suffering from bronchial asthma.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+1784,Salbutamol + Ipratropium (Inhaler),salbutamol-ipratropium-inhaler-1784,,Combined bronchodilators,Severe bronchospasm,"This inhalation aerosol is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continues to have evidence of bronchospasm and who requires a second bronchodilator.
","Combined bronchodilators
","This inhalation aerosol is a combination of Salbutamol (as Sulphate) and Ipratropium Bromide. It is a hydrofluoroalkane (HFA) based environment friendly inhaler. Because it does not contain chlorofluorocarbon (CFC) as propellant which is one of the main reasons of ozone layer depletion.
Salbutamol is a short acting beta2-adrenergic bronchodilator and Ipratropium Bromide is an anticholinergic bronchodilator. When used in combination, Ipratropium Bromide prevents the increase in intracellular concentration of cyclic guanosine monophosphate, which are caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle. This inhalation aerosol is expected to maximize the response of the treatment in patients with chronic obstructive pulmonary disease (COPD) by reducing bronchospasm through two distinctly different mechanisms, anticholinergic (parasympatholytic) and sympathomimetic. Simultaneous administration of an anticholinergic (Ipratropium Bromide) and a beta 2-sympathomimetic (Salbutamol) is designed to benefit the patient by producing a greater bronchodilatory effect than when either drug is utilized alone at its recommended dosage.
","Adult dose (Including the elderly): 2 puffs of Salpium 4 times a day (Patients may take additional puffs as required but a total number of puffs should not exceed 12 in 24 hours). Or as directed by the physician.
","Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.
Following simple steps can help to use Inhaler effectively (According to ""
National Asthma Guidelines for Medical Practitioners"" published by Asthma Association):
+
+- Take off the cap.
+- Shake the inhaler (at least six times) vigorously before each use.
+- If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
+- Breathe out as full as comfortably possible & hold the inhaler upright.
+- Place the actuator into mouth between the teeth and close lips around the mouthpiece.
+- While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
+- Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
+- If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
+- After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
+- Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.
+
+
Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.
","This inhalation aerosol has been used concomitantly with other drugs, including sympathomimetic bronchodilators, methylxanthines and steroids, commonly used in the treatment of COPD. No formal drug interaction studies have been performed with this inhalation aerosol and these or other medications commonly used in the treatment of COPD. Ipratropium Bromide should be co-administered cautiously with other anticholinergic agents and sympathomimetic agents, which may increase the risk of adverse cardiovascular effects. Beta-2-agonist containing drugs, like this inhalation aerosol, should be administrated with extreme caution in patients with non-potassium sparing diuretics, monoamine oxidase inhibitors or tricyclic antidepressants.
","This inhalation aerosol is contraindicated in patients with a history of hypersensitivity to Soya-Lecithin or related food products such as soybean and peanut. This inhalation aerosol is also contraindicated in patients hypersensitive to any other components of the drug product or to atropine or its derivatives.
","Due to presence of Salbutamol, mild tremor and headache have been reported. These usually disappear with continuous treatment. There have been very rare reports of treatments muscle cramp, hypersensitivity reactions including angioedema, urticaria, bronchospasm and hypotension.
For the presence of Ipratropium Bromide headache, influenza, chest pain, nausea, dyspnea, coughing, pharyngitis, sinusitis are rarely reported.
","Ipratropium Bromide: Pregnancy category B. Studies have demonstrated no teratogenic effects as a result of ipratropium.
Salbutamol: Pregnancy category C. Salbutamol has been shown to be teratogenic in animals.
There are, however no adequate and well-controlled studies of Salpium Inhalation Aerosol (Salbutamol and Ipratropium Bromide combination) in pregnant woman. This inhalation aerosol should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. It is not known whether the components of the Salpium InhalationAerosol are excreted in human milk. As many drugs are excreted in human milk, Salpium should be cautiously administered to a nursing mother.
",,"This inhalation aerosol contains Ipratropium Bromide and, therefore, should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction. Preparations containing sympathomimetic amines such as Salbutamol Sulphate should be used with caution in patients with convulsive disorders, hyperthyroidism, diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines.
","The effects of overdosage are expected to be related primarily to Salbutamol Sulphate. Manifestations of overdosage with Salbutamol may include anginal pain, hypertension, hypokalemia and tachycardia.
",,,"Do not puncture, break or incinerate the pressurized canister even when apparently empty. Avoid storage in direct sunlight or heat. Store in a cool and dry place. Keep away from children. Keep away from eyes.
",12
+1317,Salbutamol (Inhaler),salbutamol-inhaler-1317,https://medex.com.bd/attachments/PeLEZsSysrR4b4BFV6lueVC0YDlUvL/salbutamol-inhaler-prescribing-information,Short-acting selective & β2-adrenoceptor stimulants,Emphysema,"Bronchospasm: Salbutamol Inhaler is indicated for the treatment or prevention of bronchospasm in bronchial asthma and for the treatment of reversible airway obstruction associated with bronchitis and emphysema.
Exercise-Induced Bronchospasm: Salbutamol ... Read more
Bronchospasm: Salbutamol Inhaler is indicated for the treatment or prevention of bronchospasm in bronchial asthma and for the treatment of reversible airway obstruction associated with bronchitis and emphysema.
Exercise-Induced Bronchospasm: Salbutamol Inhaler may be used to relieve attacks of acute dyspnoea and may also be taken prophylactically before exertion or to prevent exercise-induced asthma
","Short-acting selective & β2-adrenoceptor stimulants
","Salbutamol is a selective β2-adrenoceptor agonist. At therapeutic doses, it acts on the β2-adrenoceptors of bronchial smooth muscle, with little or no action on the β1-adrenoceptors of cardiac muscle. Salbutamol provides short-acting (4-6 hours) bronchodilatation with a fast onset (within 5 minutes) in reversible airway obstruction. It also has an anti-inflammatory effect on mast cells causing inhibition of release of bronchoconstrictor mediators including histamine, neutrophil chemotactive factor (NCF) and prostaglandin D2.
","Administer Salbutamol Inhaler by oral inhalation only. Shake Salbutamol Inhaler well before each spray.
For relief of acute episodes of bronchospasm:
+
+- Adults: 1 or 2 puffs as necessary. The maximum dose is up to 8 puffs in 24 hours.
+- Children: Half the adult dose.
+
+To prevent allergen-or exercise-induced bronchospasm:
+
+- Adults: 2 puffs 15 minutes prior to exercise or exposure to the allergen. The maximum dose is 2 puffs, up to 4 times a day.
+- Children: Half the adult dose.
+
+Chronic therapy:
+
+- Adults: Up to 200 mcg (2 puffs) four times daily.
+- Children: Up to 200 mcg (2 puffs) four times daily.
+
","Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.
Following simple steps can help to use Inhaler effectively (According to ""
National Asthma Guidelines for Medical Practitioners"" published by Asthma Association):
+
+- Take off the cap.
+- Shake the inhaler (at least six times) vigorously before each use.
+- If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
+- Breathe out as full as comfortably possible & hold the inhaler upright.
+- Place the actuator into mouth between the teeth and close lips around the mouthpiece.
+- While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
+- Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
+- If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
+- After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
+- Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.
+
+
Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.
","Salbutamol and non-selective beta-blocking drugs such as propranolol should generally not be prescribed together. Potentially serious hypokalaemia may result from β2-agonist therapy. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics, and by hypoxia. It is recommended that serum potassium levels are monitored in such situations.
","Salbutamol inhaler is contraindicated in patients with a history of hypersensitivity to salbutamol or any other components of Salbutamol inhaler.
","Salbutamol is generally well tolerated. Few side effects have been observed during inhalation. There are tremors, anxiety, muscle cramps, headache, palpitation, a compensatory small increase in heart rate, cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles), tachycardia may occur in some patients. Mouth and throat irritation may occur with inhaled salbutamol
","Pregnancy Category C. There are no adequate and well-controlled studies of Salbutamol inhaler or salbutamol sulfate in pregnant women. This inhaler should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether the components of Salbutamol inhaler are excreted in human milk. Caution should be exercised when this inhaler is administered to a nursing woman.
","Paradoxical Bronchospasm: Inhaled salbutamol sulfate can produce paradoxical bronchospasm, which may be life-threatening. If paradoxical bronchospasm occurs, the Salbutamol inhaler should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm when associated with inhaled formulations; frequently occurs with the first use of a new canister.
Cardiovascular Effects: Salbutamol inhaler, like all other β2-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients such as changes in pulse rate or blood pressure. If such effects occur, Salbutamol inhaler may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiograms (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST-segment depression. The clinical relevance of these findings is unknown. Therefore, Salbutamol inhaler, like all other sympathomimetic amines, should be used with caution in patients with underlying cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions may occur after administration of salbutamol sulfate inhalation aerosol, as demonstrated by cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. Discontinue Salbutamol inhaler if immediate hypersensitivity reactions occur.
Coexisting Conditions: Salbutamol inhaler, like other sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines. Large doses of intravenous salbutamol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.
","Use in children: The safety and effectiveness of Salbutamol inhaler in children 4 years of age and older have been established.
",,,,"Pressurized canister. Do not puncture, break or burn even when apparently empty. Keep away from sunlight and heat. Store below 30°C. Do not freeze. Keep away from eyes. Keep away from children. To be dispensed only on or by the prescription of a registered physician.
",12
+1318,Salbutamol,salbutamol-1318,https://medex.com.bd/attachments/y4cI00ihlk95TKSK69u6VLzwzhG9eo/salbutamol-tablet-syrup-prescribing-information,Short-acting selective & β2-adrenoceptor stimulants,Emphysema,"Salbutamol is indicated as a bronchodilator for use in-
+
+- Asthma
+- Chronic Bronchitis
+- Emphysema and
+- Other conditions associated with airways obstruction.
+
","Short-acting selective & β2-adrenoceptor stimulants
","Salbutamol is a synthetic sympathomimetic agent with predominant beta-2 adrenergic activity. Salbutamol produces bronchodilatation through stimulation of beta-2-adrenergic receptors in bronchial smooth muscles, thereby causing relaxation of bronchial muscle fibers. This action is manifested by an improvement in pulmonary function as demonstrated by spirometric measurements.
","Salbutamol tablet or syrup-Children:
+
+- 2-6 years: 2.5 ml syrup, 3-4 times daily
+- 6-12 years: 5 ml syrup, 3-4 times daily
+- Over 12 years: 5-10 ml syrup, 3-4 times daily (2-4 mg tablet, 3-4 times daily)
+
+Adults: 2-4 mg tablet, 3-4 times daily. Maximum single dose is 8 mg tablet.
Salbutamol Respirator Solution: To be used with a suitable nebulizer device under the direction of a physician. The solution must not be injected or ingested.
Method-1 (Intermittent Administration):
+
+- Adults (and the elderly): 0.5 ml-1.0 ml salbutamol up to four times a day. Up to 40mg per day can be given under strict medical direction in the hospital. 0.5-1 ml solution should be diluted to final volume of 2-4 ml with sterile normal saline solution. It will take time about 10 minutes.
+- Salbutamol respiratory solution may be used undiluted for intermittent administration. For this 2.0 ml of the solution is placed in the nebulizer and the patient allowed to inhale until bronchodilation is achieved. This usually takes 3-5 minutes.
+- Children under 12 years of age: 0.5 ml of the solution diluted to 2.0-4.0 ml with normal saline. Some children may however require higher doses of up to 1.0 ml of the solution. Intermittent treatment may be repeated four times a day.
+
+Method-2 (Continuous administration): 1-2 ml solution is diluted to make up to 100 ml with normal saline solution. The diluted solution is administered by a suitable nebulizer devise. When there is risk of anoxia through hypoventilation, oxygen should be added to the inspired air.
Salbutamol nebulizer solution: To be used with a suitable nebulizer device under the direction of a physician. The solution must not be injected or ingested.
+
+- Adults & Elderly: 2.5 mg to 5 mg Salbutamol up to 4 times a day. Up to 40 mg/day may be given under strict medical direction in the hospital.
+- Children under 12 years: 2.5 mg up to 4 times a day. A higher dose up to 5 mg four times a day may be used if required.
+
+
Salbutamol injection:
Adults:
+
+- Salbutamol I.V. infusion solution is used to prepare a solution for continuous intravenous infusion. It should not be injected undiluted. A suitable solution for infusion may be prepared by diluting 5 mL of Salbutamol I.V. infusion solution (1000 mcg/mL) in 500 mL of a chosen i.v. solution to provide a salbutamol concentration of 10 mcg/mL.
+- The only recommended diluents are Sodium Chloride Injection, or Sodium Chloride and Dextrose Injection.
+- Infusion rates providing 3 to 20 micrograms salbutamol/minute (0.3 to 2ml/minute of the above infusion solution) are usually adequate. Infusion rates can be started at 5 mcg of salbutamol/min., and can be increased to 10 mcg/min., and 20 mcg/min. at 15 - 30 minute intervals, if necessary.
+- As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discoloration and leakage prior to administration.
+- All unused admixtures of Salbutamol infusion solution with infusion fluids should be discarded 24 hours after preparation.
+
+Children and Adolescents (<18 years of age): The dosage of Salbutamol infusion solution in the pediatric age group has not been established. At present, there are insufficient data to recommend a dosage regimen for children.
Salbutamol Inhalation Capsule:
+
+- Adults: For the relief of bronchospasm and for managing intermittent episodes of asthma, one or two inhalation capsule may be administered as a single dose. The usual recommended dosage of Salbutamol inhalation capsule for inhalation for adults for maintenance or prophylactic therapy is the contents of one 200 microgram capsule every 4 to 6 hours using a device. In some patients, the contents of two 200 microgram capsules inhaled every 4 to 6 hours may be required. Large doses or more frequent administration is not recommended. The use of salbutamol powder for inhalation can be continued as medically indicated to control recurring/intermittent episodes of bronchospasm.
+- Children: One Salbutamol inhalation capsule is the recommended dose for relief of acute bronchospasm in the maintenance of episodic asthma or before exercise of children 4 years of age and older. One inhalation should be administered for three or four times a day for routine maintenance or prophylactic therapy. This dosage may be increased to inhalation of two inhalation capsule, if necessary. The bronchodilator effect of each administration of inhaled Salbutamol inhalation capsule lasts for at least four hours. Such patients should be warned not to increase the dose of inhaler, but should seek medical advice immediately.
+
+Excercise-induced Asthma:
+
+- Adults: 400 microgram
+- Child: 200 microgram, 15-30 minutes prior to any physical exertion.
+
",,,,"Salbutamol may cause fine tremor of skeletal muscles (particularly the hands), palpitations and muscle cramps. Tachycardia, tenseness, headaches and peripheral vasodilatation have been reported after large doses.
","The drug should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. It is not known whether this drug is excreted in human milk. Because of the potential of tumorigenecity shown for Salbutamol in some animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","Salbutamol should be used with caution in patients with hyperthyroidism, cardiovascular disease, occlusive vascular disorders, hypertension and aneurysms. Hypokalaemia associated with high doses of Salbutamol may result in increased susceptibility to digitalis-induced cardiac arrhythmia. Tachyphylaxis with resistance may occur with prolonged use of high dosage. Care is necessary when treating patients with diabetes mellitus or closed angle glaucoma, and in those receiving antihypertensive therapy.
",,"The symptoms with overdosage are angina, headache, nausea, vomiting, tremor etc. The preferred antidote for overdosage with Salbutamol is a cardio-selective beta-blocking agent but beta-blocking drugs should be used with caution in patients with a history of bronchospasm.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+1365,Sacubitril + Valsartan,sacubitril-valsartan-1365,https://medex.com.bd/attachments/gXrxcYX2PFNYLxpe8dme3vDK9KTgSt/sacubitril-valsartan-prescribing-information,,,"This is indicated:
+
+- To reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class ll-IV) and reduced ejection fraction.
+- For the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.
... Read more
This is indicated:
+
+- To reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class ll-IV) and reduced ejection fraction.
+- For the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.
+- This is usually administered in conjunction with other heart failure therapies, in place of an angiotensin-converting enzyme inhibitor (ACEi) or other ARB.
+
",,"This tablet contains a neprilysin inhibitor, sacubitril, and an angiotensin receptor blocker, valsartan. This tablet inhibits neprilysin (neutral endopeptidase; NEP) via LBQ657, the active metabolite of the prodrug sacubitril, and blocks the angiotensin II type-1 (AT1 ) receptor via valsartan. The cardiovascular and renal effects of this tablet in heart failure patients are attributed to the increased levels of peptides that are degraded by neprilysin, such as natriuretic peptides, by LBQ657, and the simultaneous inhibition of the effects of angiotensin II by valsartan. Valsartan inhibits the effects of angiotensin II by selectively blocking the AT1 receptor, and also inhibits angiotensin II-dependent aldosterone release.
","Adult Heart Failure: The recommended starting dose is 49/51 mg orally twice daily. Double the dose after 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
Reduce the starting dose to 24/26 mg twice daily for:
+
+- Patients not currently taking an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) or previously taking a low dose of these agents.
+- Patients with severe renal impairment.
+- Patients with moderate hepatic impairment.
+
+
Pediatric Heart Failure: Refer to Table 1 for the recommended dose for pediatric patients aged one year and older. Take the recommended dose orally twice daily. Adjust pediatric patient doses every 2 weeks, as tolerated by the patient.
Recommended Dose Titration-Pediatric Patients Less than 40 kg:
+
+- Starting: 1.6 mg/kg
+- Second: 2.3 mg/kg
+- Final: 3.1 mg/kg
+
+Pediatric Patients At least 40 kg, less than 50 kg:
+
+- Starting: 24/26 mg
+- Second: 49/51 mg
+- Final: 49/51 mg
+
+Pediatric Patients At least 50 kg:
+
+- Starting: 49/51 mg
+- Second: 72/78 mg
+- Final: 97/103 mg
+
",," Dual Blockade of the Renin-Angiotensin-Aldosterone System: Should not be used with an ACEi, aliskiren in patients with diabetes, and use with an ARB should be avoided.
Potassium-sparing Diuretics: Serum potassium level may be increased.
NSAIDs: Risk of renal impairment may be increased.
Lithium: Increased risk of lithium toxicity.
","This combination is contraindicated:
+
+- In patients with hypersensitivity to any component
+- In patients with a history of angioedema related to previous ACE inhibitor or ARB therapy
+- With concomitant use of ACE inhibitors. Do not administer within 36 hours of switching from or to an ACE inhibitor
+- With concomitant use of aliskiren in patients with diabetes
+
","The most common side effects are Angioedema, Hypotension, Impaired Renal Function, Hyperkalemia, Cough, Dizziness.
","Pediatric Use: Safety and effectiveness have not been established in pediatric patients less than 1 year of age.
Geriatric Use: No relevant pharmacokinetic differences have been observed in elderly (>65 years) or very elderly (>75 years) patients compared to the overall population.
Hepatic Impairment: No dose adjustment is required when administering this tablet to patients with mild hepatic impairment (Child-Pugh A classification). This tablet is not recommended in patients with severe hepatic impairment, as no studies have been conducted in these patients.
Renal Impairment: No dose adjustment is required in patients with mild (eGFR 60 to 90 ml/min/1.73 m2) to moderate (eGFR 30 to 60 ml/min/1.73 m2) renal impairment. The recommended starting dose in patients with severe renal impairment (eGFR <30 ml/min/1.73 m2) is 24/26 mg twice daily.
","This tablet may cause angioedema and must not be used in patients with a known history of angioedema related to previous ACEi or ARB therapy and in patients with hereditary angioedema.
This tablet lowers blood pressure and may cause symptomatic hypotension. Closely monitor serum creatinine, and down-titrate or interrupt this tablet in patients who develop a clinically significant decrease in renal function. In patients with renal artery stenosis, monitor renal function.
Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet. Dosage reduction or interruption of this tablet may be required.
","Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: No relevant pharmacokinetic differences have been observed in elderly (≥65 years) or very elderly (≥75 years) patients compared to the overall population
Renal Impairment:
+
+- Severe: A starting dose of 24/26 mg twice-daily is recommended for patients with severe renal impairment (eGFR <30 mL/min/1.73 m²). Double the dose of Sacubitril & Valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
+- Mild or moderate: No starting dose adjustment is needed for mild or moderate renal impairment.
+
+Hepatic Impairment:
+
+- Moderate: A starting dose of 24/26 mg twice-daily is recommended for patients with moderate hepatic impairment (Child-Pugh B classification). Double the dose of Sacubitril & Valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
+- Mild: No starting dose adjustment is needed for mild hepatic impairment.
+- Severe: Use in patients with severe hepatic impairment is not recommended.
+
","Limited data are available with regard to overdosage in human subjects with this tablet. In healthy volunteers, a single dose of this tablet 583 mg sacubitril/617 mg valsartan, and multiple doses of 437 mg sacubitril/463 mg valsartan (14 days) have been studied and were well tolerated. Hypotension is the most likely result of overdosage due to the blood-pressure-lowering effects of this tablet. Symptomatic treatment should be provided. This tablet is unlikely to be removed by hemodialysis because of high protein binding.
",,,"Keep in a dry place and store below 30°C. Protect from moisture and keep out of the reach of children.
",11
+1044,Saccharin Sodium,saccharin-sodium-1044,,Oral nutritional preparations,Artificial sweetener,"Saccharin Sodium is used as a sweetening agent. It is an artificial sweetener with effectively no food energy. It is about 300-400 times as sweet as sucrose but has a bitter or metallic aftertaste, especially at high concentrations. Saccharin is used to sweeten products such as drinks, candies, cookies, and medicines.
","Oral nutritional preparations
",,"As per advised by a the physician. 1 tab is equivalent in sweetners to 1 tespoon full of sugar.
",,"There are no known drug interactions and none well documented.
",,"Saccharin belongs to a class of compounds known as sulfonamides, which can cause allergic reactions in some individuals. Reactions can include: Headaches Breathing difficulties Diarrhoea and Skin problems
","Saccharin Sodium is safe in pregnancy & lactation.
","Possibility of allergic reactions.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",8
+1828,S-Amlodipine Besilate (Levamlodipine),s-amlodipine-besilate-levamlodipine-1828,https://medex.com.bd/attachments/JfWMYPzgoq1u5ffLhII8LzNvVcZodi/s-amlodipine-besilate-levamlodipine-prescribing-information,Calcium-channel blockers,Stroke,"S-Amlodipine is calcium channel blocker and may be used alone or in combination with other antihypertensive agents for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
","Calcium-channel blockers
","Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Negative inotropic effects can be detected in vitro but such effects have not been seen in intact animals at therapeutic doses. Serum calcium concentration is not affected by amlodipine. Within the physiologic pH range, amlodipine is an ionized compound (pKa=8.6), and its kinetic interaction with the calcium channel receptor is characterized by a gradual rate of association and dissociation with the receptor binding site, resulting in a gradual onset of effect. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. Amlodipine is a 1:1 racemic mixture of levamlodipine and dextro amlodipine, it has been demonstrated that levamlodipine is the pharmacologically active, anti-hypertensive isomer.
","Adults: The usual initial antihypertensive oral dose of S-Amlodipine is 2.5 mg once daily, and the maximum dose is 5 mg once daily. Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 1.25 mg once daily and this dose may be used when adding S-Amlodipine to other antihypertensive therapy. Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently.
Children: The effective antihypertensive oral dose in pediatric patients ages 6-17 years is 1.25 mg to 2.5 mg once daily. Doses in excess of 2.5 mg daily have not been studied in pediatric patients.
",,"Impact of Other Drugs on Amlodipine-
+
+- CYP3A Inhibitors: Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A inhibitors to determine the need for dose adjustment
+- CYP3A Inducers: No information is available on the quantitative effects of CYP3A inducers on amlodipine. Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers.
+- Sildenafil: Monitor for hypotension when sildenafil is coadministered with amlodipine.
+
+Impact of Amlodipine on Other Drugs-
+
+- Simvastatin: Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.
+- Immunosuppressants: Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended and adjust the dose when appropriate
+
","S-Amlodipine is contraindicated in patients with known sensitivity to amlodipine.
","Most common adverse reactions to amlodipine is edema which occurred in a dose related manner. Other adverse experiences not dose related but reported with an incidence >1.0% are fatigue, nausea, abdominal pain and somnolence.
","The limited available data based on post-marketing reports with amlodipine use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy.
Limited available data from a published clinical lactation study reports that amlodipine is present in human milk at an estimated median relative infant dose of 4.2%. No adverse effects of amlodipine on the breastfed infant have been observed. There is no available information on the effects of amlodipine on milk production.
","Hypotension: Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely.
Increased Angina or Myocardial Infarction: Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease.
Patients with Hepatic Failure: Because amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t½) is 56 hours in patients with impaired hepatic function, titrate slowly when administering amlodipine to patients with severe hepatic impairment.
","Pediatric Use: S-Amlodipine (1.25 to 2.5 mg daily) is effective in lowering blood pressure in patients 6 to 17 years. The effect of S-Amlodipine on blood pressure in patients less than 6 years of age is not known.
Geriatric Use: Clinical studies of amlodipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients have decreased clearance of amlodipine with a resulting increase of AUC of approximately 40–60%, and a lower initial dose may be required
","Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of amlodipine is limited. Single oral doses of amlodipine equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths. Single oral amlodipine doses equivalent to 4 or more mg amlodipine/kg or higher in dogs (11 or more times the maximum recommended human dose on a mg/m² basis) caused a marked peripheral vasodilation and hypotension.
If massive overdose should occur, initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential. Should hypotension occur, provide cardiovascular support including elevation of the extremities and the judicious administration of fluids. If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with attention to circulating volume and urine output. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit.
",,,"Store bottles at 20°C to 25°C.
",12
+1467,Ruxolitinib,ruxolitinib-1467,https://medex.com.bd/attachments/ROWyR5qbLb2stFyfXYjAjy3aIWEfPX/ruxolitinib-prescribing-information,Pyrrolopyrimidines,Polycythaemia vera,"Myelofibrosis: Ruxolitinib is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults.
Polycythemia Vera: Ruxolitinib is indicated for treatment ... Read more
Myelofibrosis: Ruxolitinib is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults.
Polycythemia Vera: Ruxolitinib is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.
Acute Graft-Versus-Host Disease: Ruxolitinib is indicated for treatment of steroid-refractory acute graft-versus host disease (GVHD) in adult and pediatric patients 12 years and older.
","Pyrrolopyrimidines
","Ruxolitinib, a kinase inhibitor, inhibits Janus Associated Kinases (JAKs) JAK1 and JAK2 which mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. JAK signaling involves recruitment of STATs (signal transducers and activators of transcription) to cytokine receptors, activation and subsequent localization of STATs to the nucleus leading to modulation of gene expression. Myelofibrosis (MF) is a myeloproliferative neoplasm (MPN) known to be associated with dysregulated JAK1 and JAK2 signaling. Oral administration of ruxolitinib prevented splenomegaly, preferentially decreased JAK2V617F mutant cells in the spleen and decreased circulating inflammatory cytokines (eg, TNF-α, IL-6).
Absorption: Ruxolitinib is rapidly absorbed after oral Ruxolitinib administration with maximal plasma concentration (Cmax) achieved within 1 to 2 hours post-dose. Oral absorption of ruxolitinib was estimated to be at least 95%. Distribution: The mean volume of distribution of ruxolitinib at steady-state is 72 L in patient with MF and PV in myelofibrosis patients.
Half-life: the mean half-life of ruxolitinib & metabolites is approximately 5.8 hours. Elimination half-life: The mean elimination half-life of ruxolitinib is approximately 3 hours AUC: Mean ruxolitinib Cmax and total exposure (AUC) increased proportionally over a single dose range of 5 to 200 mg.
The plasma protein binding: 97%, mostly to albumin. Metabolism: Ruxolitinib is metabolized by CYP3A4 and to a lesser extent by CYP2C9.
Excretion: Following a single oral dose of radio labeled ruxolitinib in healthy adult subjects, elimination was predominately through metabolism with 74% of radioactivity excreted in urine and 22% excretion via feces. Unchanged drug accounted for less than 1% of the excreted total radioactivity.
","Myclofibrosis: The recommended starting dose of Ruxolitinib is based on platelet count. A complete blood count (CBC) and platelet count must be performed before initiating therapy, every 2 to 4 weeks until doses are stabilized, and then as clinically indicated. Doses may be titrated based on safety and efficacy.
+
+- Platelet count greater than 200 X 10 9 /L: Starting dose 20 mg orally twice daily.
+- Platelet count 100 X 10 9 /L to 200 X 10 9 /L: Starting dose 15 mg orally twice daily.
+- Platelet count 50 X 10 9 /L to less than 100 X 10 9 /L: Starting dose 5 mg orally twice daily.
+
+
Polycythemia Vera: The recommended starting dose of Ruxolitinib is 10 mg twice daily. Doses may be titrated based on safety and efficacy. Consider decreasing the dose to 5 mg twice daily if the hemoglobin count 8 to less than 12g/dL and the platelet count 50 to less than 75 X 10 9 L.
Acute Graft-Versus-Host Disease: The recommended dose of Ruxolitinib is 5 mg twice daily. Consider increasing the dose to 10 mg twice daily after at least 3 days of treatment if the ANC and platelet counts are not decreased by 50% or more relative to the first day of dosing with ruxolitinib. Or as directed by the registered physician.
","Ruxolitinib is to be taken orally, with or without food. If a dose is missed, the patient should not take an additional dose, but should take the next usual prescribed dose.
","Fluconazole: Concomitant administration of Ruxolitinib with fluconazole greater than 200 mg daily may increase ruxolitinib exposure due to inhibition of both the CYP3A4 and CYP2C9 metabolic pathways. Increased exposure may increase the risk of exposure-related adverse reactions. Avoid the concomitant use of Ruxolitinib with fluconazole doses of greater than 200 mg daily except in patients with acute GVHD.
Strong CYP3A4 Inhibitors: Concomitant administration of Ruxolitinib with strong CYP3A4 inhibitors increases ruxolitinib exposure. Increased exposure may increase the risk of exposure-related adverse reactions. Consider dose reduction when administering Ruxolitinib with strong CYP3A4 inhibitors. In patients with acute GVHD, reduce Ruxolitinib dose as recommended only when coadministered with ketoconazole, and monitor blood counts more frequently for toxicity and adjust the dose if necessary when coadministered with itraconazole.
Strong CYP3A4 Inducers: Concomitant administration of Ruxolitinib with strong CYP3A4 inducers may decrease ruxolitinib exposure. No dose adjustment is recommended; however, monitor patients frequently and adjust the Ruxolitinib dose based on safety and efficacy.
","It is contraindicated in patients with a history of hypersensitivity to Ruxolitinib or any other components of this product.
","The most common side effects are-
+
+- Thrombocytopenia, Anemia and Neutropenia
+- Risk of Infection, bruising, dizziness, headache
+- Symptom Exacerbation Following Interruption or Discontinuation of treatment with Ruxolitinib
+- Non-Melanoma Skin Cancer
+
","There are no adequate and well-controlled studies in pregnant women. It is not known whether Ruxolitinib is excreted in human milk. Because many drugs are excreted in human milk, breastfeeding should be discontinued during treatment with Ruxolitinib and for two weeks after the final dose.
","Thrombocytopenia, Anemia And Neutropenia: Treatment with Ruxolitinib can cause thrombocytopenia, anemia and neutropenia. Manage thrombocytopenia by reducing the dose or temporarily interrupting Ruxolitinib. Platelet transfusions may be necessary.Patients developing anemia may require blood transfusions and/or dose modifications of Ruxolitinib.Severe neutropenia (ANC less than 0.5 X 109/L) was generally reversible by withholding Ruxolitinib until recovery.Perform a pre-treatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated.
Risk of Infection: Serious bacterial, mycobacterial, fungal and viral infections have occurred. Delay starting therapy with Ruxolitinib until active serious infections have resolved. Observe patients receiving Ruxolitinib for signs and symptoms of infection and manage promptly.
Tuberculosis: Tuberculosis infection has been reported in patients receiving Ruxolitinib. Observe patients receiving Ruxolitinib for signs and symptoms of active tuberculosis and manage promptly. Prior to initiating Ruxolitinib, patients should be evaluated for tuberculosis risk factors, and those at higher risk should be tested for latent infection. Risk factors include, but are not limited to, prior residence in or travel to countries with a high prevalence of tuberculosis, close contact with a person with active tuberculosis, and a history of active or latent tuberculosis where an adequate course of treatment cannot be confirmed. For patients with evidence of active or latent tuberculosis, consult a physician with expertise in the treatment of tuberculosis before starting Ruxolitinib. The decision to continue Ruxolitinib during treatment of active tuberculosis should be based on the overall risk-benefit determination.
Progressive Multifocal Leukoencephalopathy: Progressive multifocal leukoencephalopathy (PML) has occurred with Ruxolitinib treatment. If PML is suspected, stop Ruxolitinib and evaluate.
Herpes Zoster: Advise patients about early signs and symptoms of herpes zoster and to seek treatment as early as possible if suspected.
Hepatitis B: Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking Ruxolitinib. The effect of Ruxolitinib on viral replication in patients with chronic HBV infection is unknown. Patients with chronic HBV infection should be treated and monitored according to clinical guidelines.
Symptom Exacerbation Following Interruption or Discontinuation Of Treatment With Ruxolitinib: Following discontinuation of Ruxolitinib, symptoms from myeloproliferative neoplasms may return to pretreatment levels over a period of approximately one week. Some patients with MF have experienced one or more of the following adverse events after discontinuing Ruxolitinib: fever, respiratory distress, hypotension, DIC, or multi organ failure. If one or more of these occur after discontinuation of, or while tapering the dose of Ruxolitinib, evaluate for and treat any intercurrent illness and consider restarting or increasing the dose of Ruxolitinib. Instruct patients not to interrupt or discontinue Ruxolitinib therapy without consulting their physician. When discontinuing or interrupting therapy with Ruxolitinib for reasons other than thrombocytopenia or neutropenia, consider tapering the dose of Ruxolitinib gradually rather than discontinuing abruptly.
Non-Melanoma Skin Cancer: Non-melanoma skin cancers including basal cell, squamous cell, and Merkel cell carcinoma have occurred in patients treated with Ruxolitinib. Perform periodic skin examinations.
Lipid Elevations: Treatment with Ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined in patients treated with Ruxolitinib. Assess lipid parameters approximately 8-12 weeks following initiation of Ruxolitinib therapy. Monitor and treat according to clinical guidelines for the management of hyperlipidemia.
","Use in children: The safety and effectiveness of Ruxolitinib in pediatric patients have not been established.
","There is no known antidote for overdoses with Ruxolitinib. Single doses up to 200 mg have been given with acceptable acute tolerability. Higher than recommended repeat doses are associated with increased myelosuppression including leukopenia, anemia and thrombocytopenia. Appropriate supportive treatment should be given. Hemodialysis is not expected to enhance the elimination of Ruxolitinib.
",,,"Store below 30°C in a dry place, away from sunlight. Keep out of reach of children.
",13
+972,Rupatadine Fumarate,rupatadine-fumarate-972,https://medex.com.bd/attachments/kAhk6MN7pXjzqe3quhA2QiepV6W49J/rupatadine-fumarate-tablet-prescribing-information,Non-sedating antihistamines,,"Rupatadine is indicated for the symptomatic treatment of Seasonal & Perennial Allergic Rhinitis and Urticaria.
","Non-sedating antihistamines
","Rupatadine is a long-acting, non-sedative antagonist of histamine H1-receptors. It also antagonizes the platelet activating factor (PAF). Both histamine and PAF cause broncho constriction which leads to an increase in the vascular permeability and act as a mediator in the inflammatory process. With the dual mode of action, Rupatadine shows better therapeutic effect than an isolated antihistamine. Rupatadine possesses other anti allergic properties such as the inhibition of the degranulation of mast cells induced by immunological and non immunological stimuli and inhibition of the release of cytokines, particularly of the tumor necrosis factor alpha (TNF α) in human mastocytes and monocytes.
","Adults and adolescents (over 12 years): The recommended dose is 10 mg once a day. Rupatadine may be taken with or without food.
Children aged 2 to 11 years:
+
+- Children weighing 25 kg or more: 1 teaspoonful (5 ml) of the oral solution once daily with or without food.
+- Children weighing equal or more than 10 kg to less than 25 kg: 1/2 teaspoonful (2.5 ml) oral solution once daily with or without food.
+
",,"With medicine: The concomitant administration of Rupatadine 20 mg and ketoconazole or erythromycin increases the systemic exposure. Rupatadine should be used with caution when it is administered concomitantly with these drug substances and other inhibitors of the isozyme CYP3A4. Rupatadine should be used with caution when it is co-administered with statins, CNS depressants or alcohol.
With food: Grapefruit and Grapefruit juice should not be taken simultaneously with Rupatadine
","Hypersensitivity to Rupatadine or to any of the excipients.
","Common: Asthenia, dizziness, drowsiness. Uncommon: Appetite increased, arthralgia, back pain, concentration impaired, constipation, cough, diarrhea, dry throat, epistaxis, fever, gastrointestinal discomfort, increased risk of infection, irritability, malaise, myalgia, nasal dryness, nausea, oropharyngeal pain, rash, thirst, vomiting, weight increased. Rare: Palpitations, tachycardia.
","There is no clinical data available on the exposure of Rupatadine during pregnancy. Pregnant women should therefore not use Rupatadine unless the potential benefit outweighs the potential risk for the infant. No information is available, whether Rupatadine is excreted in the mother's milk. Therefore, it should not be used during lactation, unless the potential benefits for the mother justify the potential risk to the infant.
","Rupatadine should be used with caution in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia or acute myocardial ischemia. Rupatadine should be used with caution in elderly patients (65 years and older). As there is no clinical experience in patients with impaired kidney or liver function, the use of Rupatadine 10 mg tablets is at present not recommended in these patients.
","Elderly: Rupatadine should be used with caution in elderly. No information is available that indicates the requirement of any dose adjustment in this population.
Children: Neither the safety nor the efficacy of Rupatadine has been established in patients less than 12 years of age.
Patients with renal or hepatic insufficiency: Use of Rupatadine is not recommended in patients with renal or hepatic insufficiency. As no relevant clinical data is available.
","The most common adverse reaction was somnolence. If accidental ingestion of very high doses occurs, symptomatic treatment together with the required supportive measures should be given.
",,,"Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.
",12
+971,Roxithromycin,roxithromycin-971,https://medex.com.bd/attachments/6ICdySLB4PRxLjEkhkRNKYkeOccXnt/roxithromycin-prescribing-information,Macrolides,Urethritis,"Roxithromycin is indicated in the treatment of infections caused by susceptible microorganisms-
+
+- Respiratory infections like pneumonia, acute and chronic bronchitis, and bronchopneumonia
+- ENT infections like tonsillitis, pharyngitis, sinusitis and otitis media.
... Read more
Roxithromycin is indicated in the treatment of infections caused by susceptible microorganisms-
+
+- Respiratory infections like pneumonia, acute and chronic bronchitis, and bronchopneumonia
+- ENT infections like tonsillitis, pharyngitis, sinusitis and otitis media.
+- Skin infections like folliculitis, furuncles, cellulitis, carbuncles, pyoderma, impetigo and infected dermatitis.
+- Genital infections like urethritis, prostatitis, cervicitis and salpingitis especially if produced by Chlamydia trachomatis.
+
","Macrolides
","Roxithromycin inhibits protein synthesis by irreversibly binding to the 50s ribosomal subunits thus blocking the transpeptidation or translocation reactions of susceptible organisms resulting in stunted cell growth.
","Adult dose: The usual dose for adults is one 300 mg tablet once daily or one 150 mg tablet twice a day for at least two days after resolution of symptoms, a normal course of therapy is between 5 and 10 days. Roxithromycin is best administered on empty stomach. In severe hepatic impairment the dose is 150 mg once daily.
Pediatric dose: The dose for children is 2.5 to 5 mg/kg body weight twice a day. The following general guidelines can be followed
+
+- 6 to 11 Kg: 25 mg Roxithromycin 12 hourly.
+- 12 to 23 Kg: 50 mg Roxithromycin 12 hourly.
+- 24 to 40 Kg: 100 mg Roxithromycin 12 hourly.
+
+A normal course of therapy is between 5 and 10 days.
",,"Roxithromycin does not have any affinity for cytochrome P-450 binding sites and thus is unlikely to produce drug interaction mediated by this enzymatic system. Roxithromycin shows mild interaction with theophylline though this has not been found to produce clinically relevant effects. Alteration in the pharmacokinetics of carbamazepine or warfarin has not been found. Antacids, H2- receptor antagonists and food has no effect on the absorption of Roxithromycin.
","Roxithromycin should not be administered simultaneously with ergotamine or its derivatives as it may provoke arterial spasm and severe ischaemia.
","Roxithromycin is well tolerated by patients of all age groups. Less than 4% of treated patients complain of side effects mainly nausea, abdominal pain, diarrhoea and hypersensitivity rash. Other side effects reported include vomiting, dizziness, headache, pruritus, dyspepsia, flatulence, tinnitus, vertigo and constipation. These are in general minor and do not necessitate withdrawal of therapy.
","The safety of Roxithromycin in pregnancy has not been established. It appears in breast milk in small amounts and dose not produce adverse effects in the breast fed infant.
","Roxithromycin should not be used in patients with a history of hypersensitivity to the drug. In patients with hepatic diseases the dose of Roxithromycin should not exceed 150 mg twice a day.
",,,,,,9
+1272,Roxatidine,roxatidine-1272,,H2 receptor antagonist,Zollinger-Ellison syndrome,"For the treatment of disorders of the upper gastro intestinal region that are due to an excess of hydrochloric acid in the gastric juice, i.e. duodenal ulcers, benign gastric ulcers. Also for prophylaxis of recurrent gastric and duodenal ulcers
","H2 receptor antagonist
","Roxatidine acetate suppresses the effect of histamine on the parietal cells of the stomach (H2-receptor antagonist). This suppressive action is dose-dependent. As a result, the production and secretion, particularly of gastric acid, are reduced. Roxatidine acetate has no antiandrogenic effects and does not influence drug-metabolizing enzymes in the liver.
The H2 antagonists are competitive inhibitors of histamine at the parietal cell H2 receptor. They suppress the normal secretion of acid by parietal cells and the meal-stimulated secretion of acid. They accomplish this by two mechanisms: histamine released by ECL cells in the stomach is blocked from binding on parietal cell H2 receptors which stimulate acid secretion, and other substances that promote acid secretion (such as gastrin and acetylcholine) have a reduced effect on parietal cells when the H2 receptors are blocked.
","Zollinger-Ellison syndrome: 75 mg bid.
Gastro-oesophageal reflux disease: 75 mg bid or 150 mg at bedtime for 6-8 wk.
Premedication before anaesthesia: 75 mg in the evening on the day before surgery and repeated 2 hr before induction of anaesthesia. Alternatively, 150 mg once on the night before surgery.
Peptic ulcer: 150 mg at bedtime or 75 mg bid daily for 4-6 wk. Maintenance: 75 mg at bedtime.
Gastritis: 75 mg once daily in the evening.
",,"May affect serum levels of protease inhibitors.
","Lactation, Porphyria
","Occasional headache, GI disturbances, gynaecomastia, alopecia, blood dyscrasias, pancreatitis, sleep disturbances, restlessness, rarely dizziness. Hypersensitivity reactions e.g. rash and itching reported occasionally. Changes in pulse rate and transient impairment of sexual drive. Possible increase in liver enzyme activity. May reduce leucocytes and/or thrombocytes.
","Pregnancy category is not classified. Contraindications in lactation
","Renal and hepatic impairment, pregnancy. May mask the symptoms of gastric malignancy
","Renal Impairment:Zollinger-Ellison syndrome:
+
+- CrCl <20: 75 mg every 2 days.
+- CrCl 20-50: 75 mg at bedtime.
+
+Gastro-oesophageal reflux disease:
+
+- CrCl <20: 75 mg every 2 days.
+- CrCl 20-50: 75 mg at bedtime.
+
+Peptic ulcer:
+
+- CrCl <20: 75 mg every 2 days.
+- CrCl 20-50: 75 mg at bedtime.
+
+Gastritis:
+
+- CrCl <20: 75 mg every 2 days.
+- CrCl 20-50: 75 mg at bedtime.
+
",,,,,10
+2051,Roxadustat,roxadustat-2051,https://medex.com.bd/attachments/lS5zRtr8RAdFeIaqqUNh7v6bBAkAFY/roxadustat-prescribing-information,Drugs for Haemolytic Hypoplastic & Renal Anemia,Kidney disease,"Roxadustat is indicated for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD).
","Drugs for Haemolytic Hypoplastic & Renal Anemia
","Roxadustat is an orally bioavailable, hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), with potential anti-anemic activity. Upon administration, roxadustat binds to and inhibits HIF-PH, an enzyme responsible for the degradation of transcription factors in the HIF family under normal oxygen conditions. This prevents HIF breakdown and promotes HIF activity. Increased HIF activity leads to an increase in endogenous erythropoietin production, thereby enhancing erythropoiesis. It also reduces the expression of the peptide hormone hepcidin, improves iron availability, and boosts hemoglobin (Hb) levels. HIF regulates the expression of genes in response to reduced oxygen levels, including genes required for erythropoiesis and iron metabolism.
Administration of roxadustat has been shown to induce coordinated erythropoiesis, increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range, in multiple subpopulations of CKD patients, including in the presence of infammation, and without a need for supplemental intravenous iron.
Roxadustat reversibly binds to and potently inhibits hypoxia-inducible factor (HIF) prolyl hydroxylase enzymes, reducing HIF-α breakdown and promoting HIF transcriptional activity. Activation of the HIF pathway in this manner results in the induction of target genes involved in erythropoiesis, such as those for EPO, EPO receptor, proteins promoting iron absorption, iron transport and haem synthesis. Roxadustat dose-dependently increased haemoglobin (Hb) levels, signifcantly reduced hepcidin levels and transiently increased endogenous EPO levels within or near physiological range in patients with anemia of CKD who were not dialysis dependent. Roxadustat reduced the dysregulation of iron metabolism associated with CKD by increasing serum transferrin, intestinal iron absorption and the release of stored iron in a dose-dependent manner in patients with anemia associated with dialysis dependent or dialysis-independent CKD. Cholesterol levels were also signifcantly reduced from baseline with roxadustat, regardless of the use of statins or other lipid-lowering agents.
","The appropriate dose of roxadustat must be taken orally three times per week and not on consecutive days. The dose should be individualized to achieve and maintain target Hb levels of 10 to 12 g/dL as described below:
Patients not on erythropoiesis-stimulating agent treatment: For adults, the usual starting dose is 50 mg three times weekly. The recommended starting dose of roxadustat is 70 mg three times per week in patients weighing less than 100 kg and 100 mg three times per week in patients weighing 100 kg and over.
Patients switching from erythropoiesis-stimulating agents: For adults, the usual starting dose is 70 or 100mg three times weekly. The dosage thereafter should be adjusted according to the patient's condition.
Dose adjustment: When dose adjustments are required, increase or decrease the dose according to the ""Dose increase/decrease table"" and ""stepwise Dose adjustment sequence"" below. Once adjusted, maintain the dose level for ≥4 weeks. If the hemoglobin concentration increases rapidly (>2.0 g/dL) within 4 weeks of a dose increase, decrease the dose or suspend the treatment immediately.
The stepwise dose adjustments up or down should follow the sequence of the available doses: 20 mg-40 mg-50 mg-70 mg-100 mg-150 mg-200 mg-250 mg-300 mg-400 mg (only for CKD patients on dialysis).
Missed dose: When there is ≥ 24-hour interval until the next scheduled dosing time, take the missed dose immediately and follow the prescribed schedule for subsequent doses. If there is <24 hours until the next scheduled dosing time, skip the missed dose, and take the next dose as scheduled. Do not take 2 doses on the same day.
Method of administration: Roxadustat tablets are to be taken orally with or without food.
",,"Roxadustat in combination with other medications may have drug-drug interaction.
Roxadustat with Phosphate binders and other products containing multivalent cation (EXCEPT) lanthanum carbonate:
+
+- Risk: decreased roxadustat AUC by 67% and 46% and Cmax by 66% and 52%
+- Recommendation: Roxadustat should be taken at least 1 hour after administration of phosphate binders or other medicinal products or supplements containing multivalent cations.
+
+Roxadustat with gemfbrozil (CYP2C8 and OATP1B1inhibitor) or probenecid (UGT and OAT1/OAT3 inhibitor)
+
+- Risk: increased roxadustat AUC by 2.3- fold and Cmax by 1.4-fold
+- Recommendation: Adjust the dose of roxadustat following dose adjustment rules based on Hb monitoring.
+
+Roxadustat with OATP1B1 or BCRP Substrates (simvastatin, rosuvastatin & atorvastatin)
+
+- Risk: AUC and Cmax increased
+- Recommendation: Adjust the dose of roxadustat following dose adjustment rules based on Hb monitoring.
+
",,"The common adverse reactions associated with roxadustat are hypertension, vascular access thrombosis, diarrhoea, peripheral oedema, hyperkalaemia and nausea.
","Do not administered to women that may be pregnant or pregnant. Roxadustat is contraindicated during breast-feeding.
","Roxadustat tablets should be used in caution. It may initiate few thrombotic vascular events (TVEs) particularly in patients with pre-existing risk factors for TVE, including obesity and prior history of TVEs. Roxadustat should be used with caution in patients with a history of seizures. Roxadustat should not be administered if the patient has serious signs and symptoms of an infection. Roxadustat should not be administered if the patient has liver disorder. Roxadustat should not be initiated in pregnant women.
","Children: Roxadustat is not indicated in children.
liver dysfunction patients: Roxadustat is not recommended for use in patients with severe hepatic impairment.
","Symptoms: When this drug was administered 5 mg/kg (510 mg) to a single healthy adult, increased heart rate transient have been reported. Hemoglobin concentration by overdosage of this drug is likely to increase more than necessary.
Treatment: Appropriate measures of dose reduction or interruption, etc. of this drug. This drug is not removed by dialysis.
",,,"Store in a cool (below 30°C), dry place, away from light and moisture. Keep out of the reach of children.
",11
+568,Rotavirus Vaccine,rotavirus-vaccine-568,https://medex.com.bd/attachments/VnNfB0WokMjuxp87cdYMeDg7w0oMeW/rotavirus-vaccine-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Rotavirus diarrhea,"Rotavirus vaccine is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by Types G1, G2, G3, G4, and G9 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. The first dose of Rotavirus vaccine should be administered between 6 and 12 ... Read more
Rotavirus vaccine is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by Types G1, G2, G3, G4, and G9 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. The first dose of Rotavirus vaccine should be administered between 6 and 12 weeks of age.
The vaccination series consists of 3 ready-to-use liquid doses of Rotavirus vaccine administered orally starting at 6 to 12 weeks of age, with the subsequent doses administered at 4- to 10-week intervals. The third dose should not be given after 32 weeks of age.
","Vaccines, Anti-sera & Immunoglobulin
","Rotavirus is one of the important causes of severe acute gastroenteritis in infants and young children. There are 2 commercially available forms of rotavirus vaccine. Rotavirus is a live, attenuated monovalent vaccine derived from human strain indicated for prevention of rotavirus gastroenteritis caused by G1, G3, G4 and G9 serotypes; Rotavirus as a live, pentavalent human-bovine reassortant vaccine indicated for prevention of gastreoenteritis caused by rotavirus serotypes G1, G2, G3 and G4. Although presence of porcine cirovirus (PCV1 and PCV2) DNA have been detected in the rotavirus vaccine, current available information shows that there is no evidence that PCV1 or PCV2 poses a safety risk to humans. Exact immunologic mechanism of action is not fully understood although it is known that vaccine viruses replicate in the small intestine and promote active immunity.
","The vaccination course consists of two doses. The first dose may be administered from the age of 6 weeks. There should be an interval of at least 4 weeks between the dosages. The vaccination course should be completed by the age of 24 weeks. Lyophilised vaccine to be recostituted with a liquid diluent before oral administration. After reconstitution, 1 dose (1 ml) contains- live attenuated human rotavirus RIX4414 strain not less than 106 CCID50. Repeat dosing is not indicated if an infant should spit out, regurgitate or vomit during or after the administration of the vaccine. The vaccination course should be completed as recommended above. There are no restrictions on the infant's consumption of food or liquid, including breast-milk, either before or after vaccination.
",,"Rotavirus vaccine can be given concomitantly with any of the following administered either as monovalent or as combination vaccines: Diphtheria-tetanus-whole cell pertussis vaccine (DTPw), Diphtheria-tetanus-acellular pertussis vaccine (DTPa), Haemophilus influenzae type b vaccine (Hib). inactivated Polio vaccine (IPV), Hepatitis B vaccine and Pneumococcal vaccine.
Concomitant administration of Rotavirus vaccine and oral polio vaccine (OPV) does not affect the immune response to the polio antigens. Although concomitant administration of OPV may slightly reduce the immune response to rota virus vaccine there is currently no evidence that clinical protection against severe rotavirus gastroenteritis would be affected. The immune response to Rotavirus vaccine is unaffected when OPV is administered two weeks apart from Rotavirus vaccine. Effects on ability to drive and use machines- not applicable.
","Subjects with history of intussusception. Subjects with Severe Combined Immunodeficiency (SCID) disorder The presence of a minor infection, such as a cold, is not a contraindication for immunisation.
","In controlled clinical studies, the adverse reaction profile observed in the subjects receiving Rotavirus vaccine was similar to the adverse reaction profile observed in subjects receiving placebo. No increase in the incidence or severity of these reactions was seen with the second dose.
However, some adverse reactions considered as being at least possibly related to Rotavirus vaccine vaccination were reported. Very common areirritability, loss of appetite; common arediarrhoea, vomiting, flatulence, abdominal pain, regurgitation of food, fever, fatigue; uncommon are- crying, sleep disorder, somnolence, constipation rare; upper respiratory tract infection hoarseness, rhinorrhoea, dermatitis, rash, muscle cramp; very rare- gastro-enteritis. In a large safety trial, subjects vaccinated with Rotavirus vaccine gave evidence of no increased risk of intussusception when compared with subjects receiving a placebo.
","Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","It is good clinical practice that vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination. Parents/ guardians should be advised to seek medical advice promptly where these signs/symptoms are evident. There is a potential risk for transmission to non-vaccinated contacts. It should be administered with caution to infants with close contacts who are immunodeficient, such as household members with malignancies or who are otherwise immunocompromised or receiving immunosuppressive therapy. Contacts of recent vaccinees should be advised to observe personal hygiene
",,,,,"Store refrigerated at 2° to 8°C. Protect vials from light.
",10
+970,Rosuvastatin,rosuvastatin-970,https://medex.com.bd/attachments/AVJ6W1k9cmr7IgraxreLjdketBybNE/rosuvastatin-prescribing-information,Other Anti-anginal & Anti-ischaemic drugs,Stroke,"Rosuvastatin is indicated in-
+
+- Heterozygous Hypercholesterolemia (Familial and Non familial)
+- Homozygous Hypercholesterolemia (Familial)
+- Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
+- Primary prevention of cardiovascular disease
+
","Other Anti-anginal & Anti-ischaemic drugs, Statins
","Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.
","Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg
HoFH: Starting dose 20 mg/day.
Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.
Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.
","Rosuvastatin can be taken with or without food, at any time of day.
","Remarkable drug interactions of Rosuvastatin are-
+
+- Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
+- Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
+- Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
+- Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
+- Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.
+
","Rosuvastatin is contraindicated if-
+
+- Known hypersensitivity to product components
+- Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
+- Pregnant women and women who may become pregnant
+- Nursing mothers
+
","Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.
","The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.
","Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.
Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.
Liver enzymes should be monitored before and during treatment
","Use in children: The safety and effectiveness in pediatric patients have not been established.
",,,,"Keep below 30oC temperature, protected from light & moisture. Keep out of the reach of children.
",12
+736,Rosiglitazone + Metformin Hydrochloride,rosiglitazone-metformin-hydrochloride-736,https://medex.com.bd/attachments/QOoinLvHCAiIl89yhU90liJBS29jEp/rosiglitazone-metformin-hydrochloride-prescribing-information,Combination Oral hypoglycemic preparations,Type 2 DM,"This is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus who are not adequately controlled on Metformin alone. Management of type 2 diabetes mellitus should include diet control. Caloric restriction, weight loss, and exercise are essential ... Read more
This is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus who are not adequately controlled on Metformin alone. Management of type 2 diabetes mellitus should include diet control. Caloric restriction, weight loss, and exercise are essential for the proper treatment of the diabetic patient because they help improve insulin sensitivity. This is important not only in the primary treatment of type 2 diabetes but also in maintaining the efficacy of drug therapy.
","Combination Oral hypoglycemic preparations
","Combination of two antidiabetic agents with different mechanisms of action to improve glycemic control in patients with type 2 diabetes: Rosiglitazone maleate, a member of the thiazolidinedione class, and Metformin hydrochloride, a member of the biguanide class. Thiazolidinediones are insulin sensitizing agents that act primarily by enhancing peripheral glucose utilization, whereas biguanides act primarily by decreasing endogenous hepatic glucose production.
Rosiglitazone is a highly selective and potent agonist for the peroxisome proliferator–activated receptor-gamma (PPARγ). Activation of PPARγ nuclear receptors regulates the transcription of insulin-responsive genes involved in the control of glucose production, transport, and utilization. In addition, PPARγ-responsive genes also participate in the regulation of fatty acid metabolism.
The pharmacologic mechanism of action of Metformin is different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and increases peripheral glucose uptake and utilization. Unlike sulfonylureas, With Metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease.
","The selection of the dose of Rosiglitazone and Metformin combination should be based on the patient’s current doses of Rosiglitazone and/or Metformin. The safety and efficacy of Rosiglitazone and Metformin combination as initial therapy for patients with type 2 diabetes mellitus have not been established.
The following recommendations regarding the use of Rosiglitazone and Metformin combination in patients inadequately controlled on Rosiglitazone and Metformin monotherapies are based on clinical practice experience with Rosiglitazone and Metformin combination therapy.
+
+- The dosage of antidiabetic therapy with Rosiglitazone and Metformin combination should be individualized on the basis of effectiveness and tolerability while not exceeding the maximum recommended daily dose of 8 mg/2,000 mg.
+- Rosiglitazone and Metformin combination should be given in divided doses with meals, with gradual dose escalation. This reduces GI side effects (largely due to Metformin) and permits determination of the minimum effective dose for the individual patient.
+- Sufficient time should be given to assess adequacy of therapeutic response. Fasting plasma glucose (FPG) should be used to determine the therapeutic response to Rosiglitazone and Metformin combination . After an increase in Metformin dosage, dose titration is recommended if patients are not adequately controlled after 1 to 2 weeks. After an increase in Rosiglitazone dosage, dose titration is recommended if patients are not adequately controlled after 8 to 12 weeks.
+
+
For patients inadequately controlled on Metformin monotherapy: The usual starting dose of Rosiglitazone and Metformin combination is 4 mg Rosiglitazone (total daily dose) plus the dose of Metformin already being taken.
For patients inadequately controlled on Rosiglitazone monotherapy: The usual starting dose of Rosiglitazone and Metformin combination is 1,000 mg Metformin (total daily dose) plus the dose of Rosiglitazone already being taken.
",,"If an inhibitor or an inducer of CYP2C8 (such as gemfibrozil or rifampin) is started or stopped during treatment with Rosiglitazone, changes in diabetes treatment may be needed based upon clinical response.
Although drug interactions with cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin) remain theoretical (except for cimetidine), careful patient monitoring and dose adjustment of combination of Rosiglitazone and Metformin and/or the interfering drug is recommended in patients who are taking cationic medications that are excreted via the proximal renal tubular secretory system.
When drugs that produce hyperglycemia which may lead to loss of glycemic control are administered to a patient receiving combination of Rosiglitazone and Metformin, the patient should be closely observed to maintain adequate glycemic control.
","Combination of Rosiglitazone and Metformin tablets are
contraindicated in patients with:
+
+- Renal disease or renal dysfunction which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia
+- Congestive heart failure requiring pharmacologic treatment.
+- Known hypersensitivity to Rosiglitazone maleate or Metformin hydrochloride.
+- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
+
+Combination of Rosiglitazone and Metformin should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function.
","The incidence and types of adverse events reported in clinical trials of Rosiglitazone as monotherapy are upper respiratory tract infection, headache, back pain, hyperglycemia, fatigue, sinusitis, diarrhea, and hypoglycemia. Adverse reactions reported in greater than 5% of the Metformin patients, and that were more common in Metformin- than placebo-treated patients are diarrhea, nausea, vomiting, flatulence, asthenia, indigestion, abdominal discomfort, headache.
","Pregnancy Category C. Because current information strongly suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital anomalies as well as increased neonatal morbidity and mortality, most experts recommend that insulin monotherapy be used during pregnancy to maintain blood glucose levels as close to normal as possible. Combination of Rosiglitazone and Metformin should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women with combination of Rosiglitazone and Metformin or its individual components.
It is not known whether Rosiglitazone and/or Metformin are excreted in human milk. Because many drugs are excreted in human milk, a combination of Rosiglitazone and Metformin should not be administered to a nursing woman.
","When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, a temporary loss of glycemic control may occur. At such times, it may be necessary to withhold combination of Rosiglitazone and Metformin and temporarily administer insulin. Combination of Rosiglitazone and Metformin may be reinstituted after the acute episode is resolved. Combination of Rosiglitazone and Metformin should be used with caution in patients with edema.
","Pediatric Use: Safety and effectiveness of combination of Rosiglitazone and Metformin in pdiatric patients have not been established.
Geriatric Use: Because aging is associated with reduced renal function, combination of Rosi litazone and Metformin should be used with caution as age increases. Care should be taken in dose selection and should be based on careful and regular monitoring of renal function. Generally, elderly patients should not be titrated to the maximum dose of combination of Rosiglitazone and Metformin.
",,,,"Store in a cool dry place protected from light. Keep out of reach of children.
",11
+969,Ropinirole,ropinirole-969,https://medex.com.bd/attachments/yBSkuKLQ7e1WWWBoDEFZhDbIYuUqUl/ropinirole-prescribing-information,Antiparkinson drugs,Tourette syndrome,"Ropinirole is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. It is also indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
","Antiparkinson drugs
","Ropinirole is a non-ergoline dopamine agonist. Ropinirole has the highest affinity at the D3 receptors, which are concentrated in the limbic areas of the brain and may be responsible for some of the neuropsychiatric effects. The exact mechanism of action of ropinirole as a treatment for Parkinson’s disease is unknown, however, it is believed to be related to its ability to selectively stimulate dopamine D2 receptors within the caudate-putamen system in the brain. This system affects body movement. Negligible affinity is seen for ropinirole at α2 adrenoreceptors in the periphery and 5HT-1 receptor. Ropinirole has no affinity at the D1-like receptors, benzodiazepine or GABA receptors. The precise mechanism of action of ropinirole as a treatment for Restless Legs Syndrome is unknown, however, it is believed to be related to its ability to stimulate dopamine receptors.
","Dosing for Parkinson's disease: The recommended starting dose for Parkinson's disease is 0.25 mg three times daily. Based on individual patient therapeutic response and tolerability, if necessary, the dose should then be titrated with weekly increments as described below. Maximum recommended total daily dose of 24 mg (8 mg three times daily).
+
+- Week 1: 0.25 mg 3 times daily. Total Daily Dose 0.75 mg
+- Week 2: 0.5 mg 3 times daily. Total Daily Dose 1.50 mg
+- Week 3: 0.75 mg 3 times daily. Total Daily Dose 2.25 mg
+- Week 4: 1 mg 3 times daily. Total Daily Dose 3 mg
+
+
Dosing for Restless Legs Syndrome: The recommended adult starting dose for RLS is 0.25 mg once daily 1 to 3 hours before bedtime. After 2 days, if necessary, the dose can be increased to 0.5 mg once daily, and to 1 mg once daily at the end of the first week of dosing, then as shown below as needed to achieve efficacy. Titration should be based on individual patient therapeutic response and tolerability, up to a maximum recommended dose of 4 mg daily.
+
+- Days 1 and 2: 0.25 mg, 1 to 3 hours before bedtime, to be taken once daily
+- Days 3-7: 0.5 mg, 1 to 3 hours before bedtime, to be taken once daily
+- Days 2: 1 mg, 1 to 3 hours before bedtime, to be taken once daily
+- Days 3: 1.5 mg, 1 to 3 hours before bedtime, to be taken once daily
+- Days 4: 2 mg, 1 to 3 hours before bedtime, to be taken once daily
+- Days 5: 2.5 mg, 1 to 3 hours before bedtime, to be taken once daily
+- Days 6: 3 mg, 1 to 3 hours before bedtime, to be taken once daily
+- Days 7: 4 mg, 1 to 3 hours before bedtime, to be taken once daily
+
",,"Because Ropinirole is a dopamine agonist, it is possible that dopamine antagonists such as neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metodopramide may reduce the efficacy of Ropinirole.
","It is contraindicated in patients known to have a hypersensitivity to Ropinirole.
","The most common side effects of Ropinirole include fainting, drowsiness, hallucinations, dizziness, nausea or vomiting, uncontrolled sudden movements, leg swelling, fatigue, confusion, headache, upset stomach, abdominal pain or discomfort, increased sweating etc.
","Pregnancy category C. There is no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Ropinirole inhibits prolactin secretion in human and could potentially inhibit lactation.
","Patients treated with Ropinirole have reported falling asleep while engaged in activities of daily living. Dopamine agonists in clinical trials and clinical experience appear to impair the systemic regulation of blood pressure, with resulting orthostatic hypotension.
",,,,,"Protect from light and moisture, store below 25°C. Keep out of the reach of children.
",10
+984,Sildenafil Citrate,sildenafil-citrate-984,https://medex.com.bd/attachments/LpppHtycj9NGKcCD4Mh6PDqe60q0cQ/sildenafil-citrate-prescribing-information,Drugs for Erectile Dysfunction,Pulmonary arterial hypertension,"Sildenafil is indicated for the treatment of erectile dysfunction.
","Drugs for Erectile Dysfunction
","Sildenafil is a selective inhibitor of cyclic Guanosine Monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) used for treatment of erectile dysfunction. Danafil (Sildenafil) enhances the effect of nitric oxide (NO) by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum that results in smooth muscle relaxation and inflow of blood to the corpus cavernosum.
","The recommended dose of Sildenafil is 50 mg taken approximately 1 hour before sexual activity. However, Sildenafil may be taken anywhere from half an hour to 4 hours before sexual activity. Based on effectiveness and toleration, the dose may be increased to a maximum 100 mg or decreased to 25 mg. The maximum recommended dosing frequency is once per day.
","Sildenafil may takes longer time to work if you take it with a heavy meal.
","Concomitant use of Sildenafil with organic nitrates for angina may cause hypotension. Cimetidine, a medicine used to treat gastric ulcers, some antibiotics including Erythromycin and Rifampicin, some protease inhibitors such as Ritonavir and Saquinavir for the treatment of HIV infection may increase the plasma concentration of Sildenafil. Some medicines used to treat fungal infections including Ketoconazole and Itraconazole may reduce the clearance of Sildenafil.
","Sildenafil is contraindicated in patient with hypersensitivity to any component of this medication. Sildenafil potentiates the hypotensive effects of nitrates, so it is contraindicated in patients who are using organic nitrates, either regularly or intermittently.
","The adverse effects treated with Sildenafil are headache, flushing, dyspepsia, nasal congestion, urinary tract infection, abnormal vision, diarrhea, dizziness and rash.
","Pregnancy category B. There are no adequate and well-controlled studies of Sildenafil in pregnant women. Sildenafil is not indicated for use by women. In animal study shows that Sildenafil has no evidence of teratogenicity or embryotoxicity.
","Caution should be exercised if patients have any allergies to any other medicines or any other substances such as foods, preservatives or dyes, heart or blood vessel problems, sudden loss of eyesight in one or both eyes. Caution should be taken if patients have any of the following medical conditions such as diabetes, kidney or liver problems, leukaemia, multiple myeloma, any disease or deformity of penis, any bleeding disorder such as haemophilia, stomach ulcer, sickle cell anaemia, color vision problems, sudden decrease or loss of hearing or receiving any other treatment for impotence.
",,,,,"Keep in a dry place, away from light and heat. Keep out of the reach of children.
",11
+983,Sevoflurane,sevoflurane-983,https://medex.com.bd/attachments/oB4oZut5YMpNCcLsJvayzJ776oJE0R/sevoflurane-prescribing-information,General (Inhalation) anesthetics,Obstetric analgesia,"Sevoflurane is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. Sevoflurane should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway ... Read more
Sevoflurane is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. Sevoflurane should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitationmust be immediately available. Since level of anesthesia may be altered rapidly, only vaporizers producing predictable concentrations of sevoflurane should be used.
","General (Inhalation) anesthetics
","Sevoflurane is a volatile halogenated general anaesthetic that has a minimum alveolar concentration (MAC) value ranging from 1.4% to 3.3%. It alters the activity of fast synaptic neurotransmitter receptors like nicotinic acetylcholine, GABA, and glutamate. It may depress myocardial contractility and decrease both BP and sympathetic nervous activity. Additionally, it has muscle relaxant properties w/o analgesia.
","he concentration of sevoflurane being delivered from a vaporizer during anesthesia should be known. This may be accomplished by using a vaporizer calibrated specifically for sevoflurane. The administration of general anesthesia must be individualized based on the patient's response.
Replacement Of Desiccated CO2 Absorbents: When a clinician suspects that the CO2 absorbent may be desiccated, it should be replaced. The exothermic reaction that occurs with sevoflurane and CO2 absorbents is increased when the CO2 absorbent becomes desiccated, such as after an extended period of dry gas flow through the CO2 absorbent canisters
Pre-anesthetic Medication: No specific premedication is either indicated or contraindicated with sevoflurane. The decision as to whether or not to premedicate and the choice of premedication is left to the discretion of the anesthesiologist
Induction: Sevoflurane has a nonpungent odor and does not cause respiratory irritability; it is suitable for mask induction in pediatrics and adults
Maintenance: Surgical levels of anesthesia can usually be achieved with concentrations of 0.5-3% sevoflurane with or without the concomitant use of nitrous oxide. Sevoflurane can be administered with any type of anesthesia circuit
",,"Increased metabolism and toxicity with drugs that induce CYP2E1 isoenzyme (e.g. isoniazid). Reduced MAC with benzodiazepines, opioids. May cause ventricular arrhythmia with β-sympathomimetic agents (e.g. isoprenaline), and α- and β-sympathomimetic agents (e.g. adrenaline, noradrenaline). May cause crisis during operation with nonselective MAO inhibitors. May lead to marked hypotension and risk of additive negative inotropic effect with Ca antagonists (esp dihydropyridines).
","Sevoflurane can cause malignant hyperthermia. It should not be used in patients with known sensitivity to sevoflurane or to other halogenated agents nor in patients with known or suspected susceptibility to malignant hyperthermia.
","Cardiorespiratory depression, hypotension, bradycardia; laryngospasm, increased cough and salivation; urinary retention, acute renal failure, changes in liver enzyme values, liver damage; nausea, vomiting, delirium, seizure; rash, urticaria, pruritus, dyspnoea, wheezing, chest discomfort, bronchospasm, anaphylactic/anaphylactoid reaction; agitation, dystonic movements (childn).
","Pregnancy Category B. Reproduction studies have been performed in rats and rabbits at doses up to 1 MAC (minimum alveolar concentration) without CO2 absorbent and have revealed no evidence of impaired fertility or harm to the fetus due to sevoflurane at 0.3 MAC, the highest nontoxic dose. Developmental and reproductive toxicity studies of sevoflurane in animals in the presence of strong alkalies (i.e., degradation of sevoflurane and production of Compound A) have not been conducted. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, sevoflurane should be used during pregnancy only if clearly needed.
Labor And Delivery: Sevoflurane has been used as part of general anesthesia for elective cesarean section in 29 women. There were no untoward effects in mother or neonate (see Pharmacodynamics - Clinical Trials). The safety of sevoflurane in labor and delivery has not been demonstrated.
Nursing Mothers: The concentrations of sevoflurane in milk are probably of no clinical importance 24 hours after anesthesia. Because of rapid washout, sevoflurane concentrations in milk are predicted to be below those found with many other volatile anesthetics.
","Patient with increased intracranial pressure, neuromuscular disease (esp Duchenne muscular dystrophy), mitochondrial disorders. Patient who are hypovolaemic, hypotensive, haemodynamically compromised, at risk of QT prolongation. Hepatic and renal impairment. Childn. Pregnancy and lactation.
","Geriatric Use: MAC decreases with increasing age. The average concentration of sevoflurane to achieve MAC in an 80 year old is approximately 50% of that required in a 20 year old.
Pediatric Use: Induction and maintenance of general anesthesia with sevoflurane have been established in controlled clinical trials in pediatric patients aged 1 to 18 years. Sevoflurane has a nonpungent odor and is suitable for mask induction in pediatric patients.
The concentration of sevoflurane required for maintenance of general anesthesia is age dependent. When used in combination with nitrous oxide, the MAC equivalent dose of sevoflurane should be reduced in pediatric patients. MAC in premature infants has not been determined.
The use of sevoflurane has been associated with seizures. The majority of these have occurred in children and young adults starting from 2 months of age, most of whom had no predisposing risk factors. Clinical judgement should be exercised when using sevoflurane in patients who may be at risk for seizures.
","In the event of overdosage, or what may appear to be overdosage, the following action should be taken: discontinue administration of sevoflurane, maintain a patent airway, initiate assisted or controlled ventilation with oxygen, and maintain adequate cardiovascular function.
",,,"Store between 15-30° C. Protect from light.
",12
+1348,Sevelamer Hydrochloride,sevelamer-hydrochloride-1348,https://medex.com.bd/attachments/xAA5hoiXv0bWCZDjmfhOJ1k6ONAqUc/sevelamer-hydrochloride-prescribing-information,Drugs for reduction of serum phosphorus in patients with ESRD,End-stage renal failure,"Sevelamer Hydrochloride is indicated for the reduction of serum phosphorus in patients with end-stage renal disease (ESRD).
","Drugs for reduction of serum phosphorus in patients with ESRD
","Sevelamer Hydrochloride is a new treatment for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. Elevated serum phosphorus levels or uncontrolled hyperphosphatemia leads to development of secondary hyperparathyroidism, renal bone disease, calcification of vascular and nonvascular tissues, and cardiovascular disease. It is a calcium-free and aluminium-free nonabsorbed polymer phosphate binder, it does not cause calcium and aluminium toxicity. When taken with meals it inhibits intestinal absorption of ingested phosphate.
","Patients not taking a Phosphate Binder: The recommended starting dose of Sevelamer is 800 to 1600 mg, which can be administered as two to four 400 mg Sevelamer tablets, with meals based on serum phosphorus level. Renophos 400 Recommendation for the patients with hyperphosphatemia is given below-
Starting dose of Renophos for dialysis patients not taking any phosphate binder:
+
+- Serum Phosphorus >5.5 and <7.5 mg/dL: 800 mg (2 tablets) three times daily with meals
+- Serum Phosphorus ≥7.5 and <9.0 mg/dL: 1200 mg (3 tablets) three times daily with meals
+- Serum Phosphorus ≥9.0 mg/dL: 1600 mg (4 tablets) three times daily with meals
+
+Starting dose for dialysis patients switching from calcium acetate to Sevelamer:
+
+- Calcium Acetate 667 mg (1 tablet): Sevelamer 800 mg (2 tablets)
+- Calcium Acetate 1334 mg (2 tablets): Sevelamer 1200 mg (3 tablets)
+- Calcium Acetate 2001 mg (3 tablets): Sevelamer 2000 mg (5 tablets)
+
+Dose titration guideline:
+
+- Serum Phosphorus >5.5 mg/dL: Increase 400 mg (1 tablet) per meal at 2 week intervals
+- Serum Phosphorus 3.5-5.5 mg/dL: Maintain current dose
+- Serum Phosphorus <3.5 mg/dL: Decrease 400 mg (1 tablet) per meal
+
+
Dose titration for all patients taking Sevelamer: Dosage should be adjusted based on the serum phosphorus concentration with a goal of lowering serum phosphorus to 5.5 mg/dl or less. The dose may be increased or decreased by one tablet per meal at two week intervals as necessary.
",,"Sevelamer has been studied in human drug-drug interaction studies with ciprofloxacin, digoxin, warfarin, enalapril, metoprolol and iron.
","Sevelamer is contraindicated in patients with hypophosphatemia or bowel obstruction and in patients with known hypersensitivity to Sevelamer hydrochloride or any of its constituents.
","Sevelamer may cause dyspepsia, peritonitis, diarrhea, nausea, constipation, pruritus, abdominal distension, vomiting, fatigue, anorexia, arthralgia and less commonly ileus, bowel obstruction and bowel perforation.
","Pregnancy Category C. No adequate and controlled studies have been conducted using Sevelamer in nursing mothers. Sevelamer should be used during breastfeeding only if the potential benefit justifies the potential risks.
","The safety and efficacy of Sevelamer in patients with dysphagia, swallowing disorders, severe GI motility disorders including severe constipation, or major GI tract surgery have not been established. Caution should be exercised when Sevelamer is used in patients with these GI disorders.
",,"Over dosages of Sevelamer in patients was never reported. Since Sevelamer is not absorbed, the risk of systemic toxicity is low.
",,,,10
+982,Sevelamer Carbonate,sevelamer-carbonate-982,https://medex.com.bd/attachments/3Rttbxk5x9ZWJ7cfEWPoftn7QIo23F/sevelamer-carbonate-prescribing-information,Drugs for reduction of serum phosphorus in patients with ESRD,Hyperphosphataemia,"Sevelamer Carbonate is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer Carbonate is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus 1.78 ... Read more
Sevelamer Carbonate is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer Carbonate is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus 1.78 mmol/l. Sevelamer Carbonate should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
","Drugs for reduction of serum phosphorus in patients with ESRD
","Sevelamer carbonate, a non-absorbed phosphate binding crosslinked polymer, free of metal and calcium. It contains multiple amines separated by one carbon from the polymer backbone. These amines exist in a protonated form in the intestine and interact with phosphate molecules through ionic and hydrogen bonding. By binding phosphate in the gastrointestinal tract and decreasing absorption, sevelamer carbonate lowers the phosphate concentration in the serum (serum phosphorus).
","Starting dose: The recommended starting dose of Sevelamer Carbonate is 2.4 g (Three Sevelamer 800 mg tablets or Three Sevelamer 800 mg sachets of powder for oral suspension) or 4.8 g (Six Sevelamer 800 mg tablets or Six Sevelamer 800 mg sachets of powder for oral suspension) per day based on clinical needs and serum phosphorus level. Sevelamer Carbonate tablet or suspension must be taken three times per day with meals.
For patients previously on phosphate binders (Sevelamer Hydrochloride or calcium based), Sevelamer Carbonate should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily doses.
Titration and Maintenance: Serum phosphorus levels must be monitored and the dose of Sevelamer Carbonate titrated every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter. Patients taking Sevelamer Carbonate should adhere to their prescribed diets. In clinical practice, treatment will be continuous based on the need to control serum phosphorus levels and the daily dose is expected to be an average of approximately 6 g per day.
Paediatric population: The safety and efficacy of Sevelamer Carbonate has not been established in children below the age of 18 years. Sevelamer Carbonate is not recommended in children below the age of 18 years.
","Method of administration for Sevelamer Carbonate tablet: Tablets should be swallowed intact and should not be crushed, chewed, or broken into pieces prior to administration.
Method of administration for Sevelamer Carbonate powder for oral suspension: Each sachet of 800 mg of powder is to be dispersed in 30 ml or 6 teaspoons of water prior to administration. The suspension should be ingested within 30 minutes after being prepared.
","Drug interactions: Interaction studies have not been conducted in patients on dialysis. In interaction studies in healthy volunteers, Sevelamer Hydrochloride, which contains the same active moiety as Sevelamer Carbonate, decreased the bioavailability of ciprofloxacin by approximately 50% when co-administered with Sevelamer Hydrochloride in a single dose study. Consequently, Sevelamer Carbonate should not be taken simultaneously with ciprofloxacin. Reduced levels of ciclosporin, mycophenolate mofetil and tacrolimus have been reported in transplant patients when co-administered with Sevelamer Hydrochloride without any clinical consequences (i.e graft rejection). The possibility of an interaction cannot be excluded and a close monitoring of blood concentrations of ciclosporin, mycophenolate mofetil and tacrolimus should be considered during the use of combination and after its withdrawal. Very rare cases of hypothyroidism have been reported in patients co-administered Sevelamer Hydrochloride, which contains the same active moiety as Sevelamer Carbonate, and levothyroxine. Closer monitoring of thyroid stimulating hormone (TSH) levels is therefore recommended in patients receiving Sevelamer Carbonate and levothyroxine. Patients taking anti-arrhythmic medicinal products for the control of arrhythmias and anti-seizure medicinal products for the control of seizure disorders were excluded from clinical trials. Caution should be exercised when prescribing Sevelamer Carbonate to patients also taking these medicinal products. In interaction studies in healthy volunteers, Sevelamer Hydrochloride, which contains the same active moiety as Sevelamer Carbonate, had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol. Sevelamer Carbonate is not absorbed and may affect the bioavailability of other medicinal products. When administering any medicinal product where a reduction in the bioavailability could have a clinically significant effect on safety or efficacy, the medicinal product should be administered at least one hour before or three hours after Sevelamer Carbonate, or the physician should consider monitoring blood levels.
","Sevelamer Carbonate is contraindicated in patients with bowel obstruction. Sevelamer Carbonate is contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients.
",,"Sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. Clinical Considerations Sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women.
Sevelamer carbonate is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to Sevelamer carbonate. Clinical Considerations Sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women.
",,"Pediatric Use: The safety and efficacy of Sevelamer Carbonate in lowering serum phosphorus levels was studied in patients 6 years of age and older with CKD. In this study, Sevelamer Carbonate was apparently less effective in children with a low baseline serum phosphorus, which described children < 13 years of age and children not on dialysis. Given its mechanism of action, Sevelamer Carbonate is expected to be effective in lowering serum phosphorus levels in pediatric patients with CKD. Most adverse events that were reported as related, or possibly related, to sevelamer carbonate were gastrointestinal in nature. No new risks or safety signals were identified with the use of sevelamer carbonate in the trial. Sevelamer Carbonate has not been studied in pediatric patients below 6 years of age.
Geriatric Use: Clinical studies of Sevelamer Carbonate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.
","In CKD patients on dialysis, the maximum dose studied was 14 grams of sevelamer carbonate and 13 grams of sevelamer hydrochloride. There are no reports of overdosage with sevelamer carbonate or sevelamer hydrochloride in patients. Since sevelamer is not absorbed, the risk of systemic toxicity is low.
",,,"Store in a cool and dry place, protected from light.
",11
+1841,Sesame oil + Cactus extract + Beeswax,sesame-oil-cactus-extract-beeswax-1841,,Topical retinoid and related preparations,Rough skin,"
+- It is completely natural and uses the goodness of cactus extract and beeswax which improves skin elasticity and scars
+- Reduces scar formation and improve physiological regeneration of the skin due to several skin trauma
+- It works by inhibiting hyperplasia of fibroblasts and improves epithelia cell growth
... Read more
+- It is completely natural and uses the goodness of cactus extract and beeswax which improves skin elasticity and scars
+- Reduces scar formation and improve physiological regeneration of the skin due to several skin trauma
+- It works by inhibiting hyperplasia of fibroblasts and improves epithelia cell growth
+- It flattens scars and recovers skin's natural beauty
+- Helps to relieve scar location and its symptoms such as skin hyperplasia, pruritus, skin chaps and functional restriction
+
","Topical retinoid and related preparations
","This Ointment is used primarily to remove scars and repair damaged skin. It helps to relieve symptoms of scars including pruritus, skin chaps and functional restriction. The ointment is chiefly used to heal scar formation caused due to injury of the skin or due to various skin disorders.
","Apply a thin layer of the ointment and gently massage the skin mark area for 5-10 minutes. Repeat 3 to 4 times daily. Continue using until the skin mark become soft and smooth. The duration of usages varies depending on the type of the skin, age and location of the skin mark.
",,,,,,,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",5
+981,Sertraline Hydrochloride,sertraline-hydrochloride-981,https://medex.com.bd/attachments/0LfEWiXtHsgmVDPKtcuc3KOn6SYpZI/sertraline-hydrochloride-prescribing-information,SSRIs & related anti-depressant drugs,Trichotillomania,"Sertraline is indicated for the treatment of-
+
+- Major depressive disorder (MDD)
+- Obsessive-compulsive disorder (OCD)
+- Panic disorder (PD)
+- Post-traumatic stress disorder (PTSD)
+- Social anxiety disorder (SAD)
+- Premenstrual dysphoric disorder (PMDD).
+
","SSRIs & related anti-depressant drugs
","Sertraline has potent and selective inhibitory action on CNS neuronal reuptake of 5-HT resulting in increased 5-HT concentrations at the synaptic clefts, leading to facilitation of its sustained activity at the postsynaptic receptor sites. It ultimately results in an improvement of depression. Reduction of Serotonin turnover in brain by Sertraline is also another contributing fact implicated in its action. Its prolonged elimination half-life offers a benefit of once daily administration.
","Adults-
Major depressive disorder:
+
+- Starting Dose: 50 mg
+- Therapeutic Range: 50-200 mg
+
+Obsessive-compulsive disorder:
+
+- Starting Dose: 50 mg
+- Therapeutic Range: 50-200 mg
+
+Panic disorder, Post-traumatic stress disorder, Social anxiety disorder:
+
+- Starting Dose: 25 mg
+- Therapeutic Range: 50-200 mg
+
+
Pediatric Patients (ages 6-12 years old)-
Obsessive-compulsive disorder:
+
+- Starting Dose: 25 mg
+- Therapeutic Range: 50-200 mg
+
+The recommended interval between dose changes is one week.
Premenstrual dysphoric disorder (PMDD): Starting dosage for PMDD is 50 mg/day. Sertraline may be administered either continuously (every day throughout the menstrual cycle) or intermittently (starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing would be repeated with each new cycle.
+
+- Continuous: Patients not responding to a 50 mg dosage may benefit from dosage increases at 50 mg increments per menstrual cycle up to 150 mg per day.
+- Intermittent: Patients not responding to a 50 mg dosage may benefit from increasing the dosage up to a maximum of 100 mg per day during the next menstrual cycle (and subsequent cycles).
+
",,"Potential effects of co-administration of drugs that are highly bound to plasma proteins- As Sertraline is tightly bound to plasma protein, the administration of Sertraline to a patient taking another drug which is tightly bound to protein, (e.g. warfarin, digitoxin) may cause a shift in plasma concentrations potentially resulting in an adverse effect. Conversely adverse effects may result from displacement of protein bound Sertraline by other tightly bound drugs. Sertraline may interact with other drugs such as Cimetidine, CNS active drugs like Diazepam, Hypoglycemic drugs, Atenolol etc.
","Sertraline is contraindicated in patients with a known hypersensitivity to Sertraline or any of the excipients of drug. In patients with moderate to severe hepatic impairment is not recommended.
","Sertraline may cause side effects like upset stomach, diarrhoea, constipation, vomiting, dry mouth, loss of appetite, weight changes, drowsiness, dizziness, headache, pain, burning or tingling in the hands or feet, excitement, sore throat etc.
","Although animal studies did not provide any evidence of teratogenicity, the safety of Sertraline during human pregnancy has not been established. Sertraline is known to be excreted in breast milk. Its effects on the nursing infant have not yet been established. If treatment with Sertraline is considered necessary, discontinuation of breast-feeding should be considered.
","Precaution should be taken in case of liver problems, kidney diseases, seizures, heart problems and any allergies. This drug may cause dizziness or drowsiness. Caution should be taken in activities requiring alertness such as driving or using machinery. Caution is advised while using this product in the elderly because they may be more sensitive to the effects of the drug. Do not take this drug if you have taken monoamine oxidase inhibitor in the last five weeks. Risk of suicidal thinking and change of behavior may occur (close monitoring of the patient after 2 to 3 weeks of use is required).
",,,,,"Do not store above 30°C. Keep out of the reach of children.
",10
+1424,Sertaconazole Nitrate,sertaconazole-nitrate-1424,https://medex.com.bd/attachments/JBDiNuslyuNzDosjXkBMvBPIGVTqfj/sertaconazole-nitrate-prescribing-information,Topical Antifungal preparations,Tinea pedis (athlete’s foot),"Sertaconazole cream is indicated for the topical treatment of interdigital tinea pedis and other topical fungal infections in immunocompetent patients 12 years of age and older, caused by Trichophyton rubrum, Trichophyton mentagrophytes and Epidermophyton floccosum.
","Drugs used in Vaginal and Vulval condition, Topical Antifungal preparations
","Sertaconazole, an imidazole antifungal agent, inhibits fungal cytochrome P450-mediated 14 alpha-lanosterol demethylase enzyme. Ergosterol is the key component of fungal cell membranes and lack of this component leads to fungal cell injury by leakage of key constituents in the cytoplasm from the cell.
","In the treatment of interdigital tinea pedis, Sertaconazole cream should be applied twice daily for 4 weeks. A sufficient amount of Sertaconazole cream should be applied to cover both the affected areas between the toes and the immediately surrounding healthy skin of patients with interdigital tinea pedis. Not for ophthalmic, oral, or intravaginal use.
Pediatric Use: The efficacy and safety of Fungitac cream 2% have not been established in pediatric patients below the age of 12 years.
Geriatric Use: Clinical trials of Fungitac cream 2% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
",,"Potential interactions between Sertaconazole cream and other drugs have not been systematically evaluated.
","Sertaconazole cream is contraindicated in patients who have a known or suspected hypersensitivity to sertaconazole nitrate or any of its components or other imidazoles.
","Most common adverse reactions observed in clinical trials are contact dermatitis, dry skin, burning skin, application site skin tenderness.
","There are no adequate & well-controlled studies conducted with Sertaconazole cream in pregnant women. Sertaconazole cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Sertaconazole cream is excreted in human milk. Caution should be exercised when prescribing Sertaconazole cream to a nursing woman.
","Sertaconazole cream is for use on the skin only. If irritation develops, treatment should be discontinued and appropriate therapy instituted. Physicians should exercise caution when prescribing Sertaconazole cream to patients known to be sensitive to azole antifungals, since cross-reactivity may occur.
",,"There is no data availalble about overdose of Sertaconazole cream.
",,,"Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light.
",11
+980,Sennosides,sennosides-980,,Osmotic purgatives,Constipation,"It is used to treat hard stools (constipation).
","Osmotic purgatives
","Senna glycoside, also known as sennoside or senna, is a medication used to treat constipation and empty the large intestine before surgery. The medication is taken by mouth or via the rectum. It typically begins working in minutes when given by rectum and within twelve hours when given by mouth. It is a weaker laxative than bisacodyl or castor oil.
Sennosides A and B increase intestinal motility through release of active anthraquinones into the colon by colonic bacteria. Purified sennosides (sennosides A and B) are used similarly to senna.
","Constipation
+
+- Adult: 15-30 mg (as total sennosides) 1-2 times daily.
+- Child: 2-6 yr: 3.75-7.5 mg once daily in the morning; 6-12 yr: 7.5-15 mg once daily at night or in the morning; ≥12 yr: 15-30 mg at bedtime.
+
+Bowel evacuation
+
+- Adult: 105-157.5 mg of sennosides on the day before the procedure. May be given as a liquid preparation.
+
",,,"Nausea or vomiting, undiagnosed abdominal pain, intestinal obstruction.
","Mild abdominal discomfort e.g. colic and cramps; diarrhoea, hypokalaemia and atonic non-functioning colon (prolonged use); reversible melanosis coli (chronic use). May colour the urine yellowish-brown at acidic pH or red at alkaline pH.
","Sennosides has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy. Sennosides should only be given during pregnancy when benefits outweigh risks.
Sennosides is not excreted into human milk. However, Sennosides is a prodrug which is metabolized in vivo to the active sennosides (glucosides of rhein). Rhein is excreted into human milk in very small amounts. No adverse effects have been observed in nursing infants. The American Academy of Pediatrics considers Sennosides to be compatible with breast-feeding.
","Inflammatory bowel disease. Avoid prolonged use.
",,,,,,8
+1971,Semaglutide (Tablet),semaglutide-tablet-1971,https://medex.com.bd/attachments/C3vK7dMbXprHv8RotE61ev4QpH3aIE/semaglutide-tablet-prescribing-information,GLP-1 receptor agonists,Type 2 DM,"Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
","GLP-1 receptor agonists
","Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors. The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme. Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.
","Instruct patients to take Semaglutide at least 30 minutes before the first food, beverage, or other oral medications of the day with no more than 4 ounces of plain water only. Waiting less than 30 minutes, or taking with food, beverages (other than plain water) or other oral medications will lessen the effect of Semaglutide. Waiting more than 30 minutes to eat may increase the absorption of Semaglutide.
Swallow tablets whole. Do not cut, crush, or chew tablets. Start Semaglutide with 3 mg once daily for 30 days. After 30 days on the 3 mg dose, increase the dose to 7 mg once daily. Dose may be increased to 14 mg once daily if additional glycemic control is needed after at least 30 days on the 7 mg dose.
",,"Oral Medications: Semaglutide delays gastric emptying. When coadministering oral medications instruct patients to closely follow semaglutide administration instructions. Consider increased clinical or laboratory monitoring for medications that have a narrow therapeutic index or that require clinical monitoring.
","Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2. Known hypersensitivity to semaglutide or any of the components in this preparation.
","The most common adverse reactions, reported in ≥5% of patients treated with Semaglutide are: nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation.
","Pregnancy: May cause fetal harm.
Lactation: Breastfeeding not recommended.
Females and Males of Reproductive Potential: Discontinue Semaglutide in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide.
","Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
Diabetic Retinopathy Complications: Has been reported in a cardiovascular outcomes trial with semaglutide injection. Patients with a history of diabetic retinopathy should be monitored.
Hypoglycemia: When semaglutide is used with an insulin secretagogue or insulin, consider lowering the dose of the secretagogue or insulin to reduce the risk of hypoglycemia.
Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.
Hypersensitivity Reactions: Discontinue semaglutide if suspected and promptly seek medical advice.
","Pediatric Use: Safety and efficacy of Semaglutide have not been established in pediatric patients (younger than 18 years).
Geriatric Use: No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Renal Impairment: The safety and efficacy of Semaglutide was evaluated in a 26-week clinical study that included 324 patients with moderate renal impairment (eGFR 30 to 59 mL/min/1.73 m2). In patients with renal impairment including end-stage renal disease (ESRD), no clinically relevant change in semaglutide pharmacokinetics (PK) was observed. No dose adjustment of Semaglutide is recommended for patients with renal impairment.
Hepatic Impairment: In a study in subjects with different degrees of hepatic impairment, no clinically relevant change in semaglutide pharmacokinetics (PK) was observed. No dose adjustment of Semaglutide is recommended for patients with hepatic impairment.
","In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of Semaglutide of approximately 1 week.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+1969,Semaglutide (Injection),semaglutide-injection-1969,https://medex.com.bd/attachments/xmIX0xFKcWdi7bE9aI4YCLrsFygcCh/semaglutide-injection-prescribing-information,GLP-1 receptor agonists,Type 2 DM,"Semaglutide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Semaglutide is not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent ... Read more
Semaglutide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Semaglutide is not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Semaglutide has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Semaglutide is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of patients with diabetic ketoacidosis, as it would not be effective in these settings.
","GLP-1 receptor agonists
","Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors. The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme. Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.
","Instruct patients to take Semaglutide at least 30 minutes before the first food, beverage, or other oral medications of the day with no more than 4 ounces of plain water only. Waiting less than 30 minutes, or taking Semaglutide with food, beverages (other than plain water) or other oral medications will lessen the effect of Semaglutide by decreasing its absorption. Waiting more than 30 minutes to eat may increase the absorption of Semaglutide. Swallow tablets whole. Do not split, crush, or chew tablets.
+
+- Start Semaglutide with 3 mg once daily for 30 days. The 3 mg dose is intended for treatment initiation and is not effective for glycemic control.
+- After 30 days on the 3 mg dose, increase the dose to 7 mg once daily.
+- Dose may be increased to 14 mg once daily if additional glycemic control is needed after at least 30 days on the 7 mg dose.
+- Taking two 7 mg Semaglutide tablets to achieve a 14 mg dose is not recommended.
+- If a dose is missed, the missed dose should be skipped, and the next dose should be taken the following day.
+
",,"Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin: The risk of hypoglycemia is increased when Semaglutide is used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin.
Oral Medications: Semaglutide causes a delay of gastric emptying, and thereby has the potential to impact the absorption of other oral medications. Levothyroxine exposure was increased 33% when administered with Semaglutide in a drug interaction study. When coadministering oral medications instruct patients to closely follow Semaglutide administration instructions. Consider increased clinical or laboratory monitoring for medications that have a narrow therapeutic index or that require clinical monitoring.
","Semaglutide is contraindicated in patients with:
+
+- A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
+- Known hypersensitivity to semaglutide or to any of the components in Semaglutide.
+
","The following serious adverse reactions are described below or elsewhere in the prescribing information:
+
+- Risk of Thyroid C-cell Tumors
+- Pancreatitis
+- Diabetic Retinopathy Complications
+- Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin
+- Acute Kidney Injury
+- Hypersensitivity
+
","Available data with Semaglutide use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy. There are no data on the presence of semaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. Semaglutide was present in the milk of lactating rats.
","
+- Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
+- Diabetic Retinopathy Complications: Has been reported in a cardiovascular outcomes trial with semaglutide injection. Patients with a history of diabetic retinopathy should be monitored.
+- Hypoglycemia: When semaglutide is used with an insulin secretagogue or insulin, consider lowering the dose of the secretagogue or insulin to reduce the risk of hypoglycemia.
+- Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.
+- Hypersensitivity Reactions: Discontinue semaglutide if suspected and promptly seek medical advice.
+
","Pediatric Use: Safety and efficacy of Semaglutide have not been established in pediatric patients (younger than 18 years).
Geriatric Use: No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Renal Impairment: The safety and efficacy of Semaglutide was evaluated in a 26-week clinical study that included 324 patients with moderate renal impairment (eGFR 30 to 59 mL/min/1.73 m2). In patients with renal impairment including end-stage renal disease (ESRD), no clinically relevant change in semaglutide pharmacokinetics (PK) was observed. No dose adjustment of Semaglutide is recommended for patients with renal impairment.
Hepatic Impairment: In a study in subjects with different degrees of hepatic impairment, no clinically relevant change in semaglutide pharmacokinetics (PK) was observed. No dose adjustment of semaglutide is recommended for patients with hepatic impairment.
","In the event of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of Semaglutide of approximately 1 week.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+2036,Selexipag,selexipag-2036,https://medex.com.bd/attachments/kieG2u9iTfOLAem7eeh9D1qJSjOyuF/selexipag-prescribing-information,Non-prostanoid IP prostacyclin receptor agonist,Pulmonary arterial hypertension,"Selexipag is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.
","Non-prostanoid IP prostacyclin receptor agonist
","Selexipag is a selective non-prostanoid IP prostacyclin receptor agonist. Selexipag is a pale yellow crystalline powder that is practically insoluble in water. In the solid-state selexipag is very stable, is not hygroscopic, and is not light sensitive. Selexipag is an oral prostacyclin receptor (IP receptor) agonist that is structurally distinct from prostacyclin. Selexipag is hydrolyzed by carboxylesterase 1 to yield its active metabolite, which is approximately 37-fold as potent as selexipag. Selexipag and the active metabolite are selective for the IP receptor versus other prostanoid receptors (EP1-4, DP, FP, and TP).
","The recommended starting dose is 200 mcg twice daily. Tolerability may be improved when taken with food. Increase the dose by 200 mcg twice daily at weekly intervals to the highest tolerated dose up to 1600 mcg twice daily. The maintenance dose is determined by tolerability.
Pediatric use: Safety and effectiveness in pediatric patients have not been established.
Geriatric use: No overall differences have been observed.
Hepatic impairment: For Moderate hepatic impairment patients starting dose is 200 mcg once daily, increase the dose by 200 mcg once daily at weekly intervals to the highest tolerated dose up to 1600 mcg. Avoid use of Selexipag in patients with severe hepatic impairment (Child-Pugh class C).
",,"Moderate CYP2C8 inhibitors (e.g., deferasirox and teriflunomide) may increase exposure to the active metabolite of Selexipag: CYP2C8 inducers (e.g., rifampicin) decrease exposure to the active metabolite & Increase concentration up to twice the dose of Selexipag
",,"The most common side-effects of selexipag are Nausea, Diarrhoea, Vomiting, Headache, Jaw pain, muscle pain, low appetite and low RBC count.
","There are no adequate and well controlled studies with Selexipag in pregnant women It is not known if Selexipag is present in human milk. Selexipag or breastfeeding should be discontinued in nursing mother.
","Discontinue Selexipag if the patient develops the sign and symptoms of Pulmonary Veno-Occlusive Disease (PVOD)
",,"Isolated cases of overdose up to 3200 mcg were reported. Mild transient nausea was the only reported consequence. In the event of overdose, supportive measures must be taken as required.
",,,"Keep in a dry place away from light and heat. Keep out of reach of children.
",10
+1422,Selegiline Hydrochloride,selegiline-hydrochloride-1422,https://medex.com.bd/attachments/o1qAwL23I6SuutOrPC8K26hD6KbhHG/selegiline-hydrochloride-prescribing-information,Antiparkinson drugs,Parkinson’s disease,"Selegiline is indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that selegiline has any beneficial effect in the absence of ... Read more
Selegiline is indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that selegiline has any beneficial effect in the absence of concurrent levodopa therapy.
Evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving levodopa/carbidopa. Selegiline was significantly superior to placebo on all three principal outcome measures employed: change from baseline in daily levodopa/carbidopa dose, the amount of 'off' time, and patient selfrating of treatment success. Beneficial effects were also observed on other measures of treatment success (e.g., measures of reduced end of dose akinesia, decreased tremor and sialorrhea, improved speech and dressing ability and improved overall disability as assessed by walking and comparison to previous state).
","Antiparkinson drugs
","Although the mechanisms for selegiline's beneficial action in the treatment of Parkinson's disease are not fully understood, the selective, irreversible inhibition of monoamine oxidase type B (MAO-B) is thought to be of primary importance. MAO-B is involved in the oxidative deamination of dopamine in the brain. Selegiline binds to MAO-B within the nigrostriatal pathways in the central nervous system, thus blocking microsomal metabolism of dopamine and enhancing the dopaminergic activity in the substantial nigra. Selegiline may also increase dopaminergic activity through mechanisms other than inhibition of MAO-B. At higher doses, selegiline can also inhibit monozmine oxidase type A (MAO-A), allowing it to be used for the treatment of depression.
","Selegiline Hydrochloride is intended for administration to Parkinsonian patients receiving levodopa/carbidopa therapy who demonstrate a deteriorating response to this treatment. The recommended regimen for the administration of Selegiline Hydrochloride is 10 mg per day administered as divided doses of 5 mg each taken at breakfast and lunch. There is no evidence that additional benefit will be obtained from the administration of higher doses. Moreover, higher doses should ordinarily be avoided because of the increased risk of side effects.
After two to three days of selegiline treatment, an attempt may be made to reduce the dose of levodopa/carbidopa. A reduction of 10 to 30% was achieved with the typical participant in the domestic placebo controlled trials who was assigned to selegiline treatment. Further reductions of levodopa/carbidopa may be possible during continued selegiline therapy
",,,"Selegiline is contraindicated in patients with a known hypersensitivity to this drug. Selegiline is contraindicated for use with meperidine. This contraindication is often extended to other opioids.
",,"Pregnancy Category C. No teratogenic effects were observed in a study of embryo-fetal development in Sprague-Dawley rats at oral doses of 4, 12, and 36 mg/kg or 4, 12 and 35 times the human therapeutic dose on a mg/m2 basis.
Nursing Mothers: It is not known whether selegiline hydrochloride is excreted in human milk. Because many drugs are excreted in human milk, consideration should be given to discontinuing the use of all but absolutely essential drug treatments in nursing women.
","Some patients given selegiline may experience an exacerbation of levodopa associated side effects, presumably due to the increased amounts of dopamine reaction with super sensitive, post-synaptic receptors. These effects may often be mitigated by reducing the dose of levodopa/carbidopa by approximately 10 to 30%.
The decision to prescribe selegiline should take into consideration that the MAO system of enzymes is complex and incompletely understood and there is only a limited amount of carefully documented clinical experience with selegiline. Consequently, the full spectrum of possible responses to selegiline may not have been observed in pre-marketing evaluation of the drug. It is advisable, therefore, to observe patients closely for atypical responses.
","Renal Impairment: No pharmacokinetic information is available on selegiline or its metabolites in renally impaired subjects.
Hepatic Impairment: No pharmacokinetic information is available on selegiline or its metabolites in hepatically impaired subjects.
Pediatric Use: The effects of selegiline hydrochloride in children have not been evaluated.
",,,,,8
+1464,Secukinumab,secukinumab-1464,https://medex.com.bd/attachments/E3gyWcyVGvd8sFS7iA1RgZ0w52COFw/secukinumab-prescribing-information,Drugs for Osteoarthritis,Rheumatoid arthritis,"Secukinumab is a human interleukin-17A antagonist indicated for the treatment of:
+
+- Moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy
+- Adults with active psoriatic arthritis (PsA)
+- Adults with active ankylosing spondylitis (AS)
+
","Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis
","Secukinumab is a human monoclonal antibody that targets IL-17A cytokine to downregulate inflammation in psoriasis, an autoimmune dermatological disease. The pathophysiology of psoriasis has not been fully established, however it is known that dysregulation of innate and adaptive immune responses plays part in the chronic inflammation associated with the disease. IL-17 represents is a six-membered family (IL-17A to F) of pleiotropic pro-inflammatory cytokines, expression of which is found to be elevated in psoriatic skin. These cytokines act on many different cell types and provide defense against different extracellular pathogens causing fungal or bacterial infections. IL-17 cytokines are produced by many cells involved in immune system defense, such as Th17, mast cells, neutrophils, and dendritic cells - all implicated in promoting inflammation. There is evidence linking IL-17 to pathogenesis of multiple autoimmune diseases including rheumatoid arthritis, spondyloarthritis, psoriasis, Crohn's disease, multiple sclerosis, and even atherosclerosis.
","Plaque Psoriasis-1. Recommended dosage is 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks. For some patients, a dose of 150 mg may be acceptable.
Psoriatic Arthritis-1. For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, use the dosage and administration for plaque psoriasis.
2. For other psoriatic arthritis patients administer with or without a loading dosage. The recommended dosage:
+
+- With a loading dosage is 150 mg at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter
+- Without a loading dosage is 150 mg every 4 weeks
+- If a patient continues to have active psoriatic arthritis, consider a dosage of 300 mg.
+
+
Ankylosing Spondylitis-1. Administer with or without a loading dosage. The recommended dosage:
+
+- With a loading dosage is 150 mg at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter
+- Without a loading dosage is 150 mg every 4 weeks
+
",,"Live vaccines should not be given with Secukinumab
","Serious hypersensitivity reaction to secukinumab or to any of the excipients.
","Most common adverse reactions (greater than 1%) are nasopharyngitis, diarrhea, and upper respiratory tract infection.
","Pregnancy: Limited available human data with secukinumab use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. In an embryo-fetal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of secukinumab during organogenesis at doses up to 30 times the maximum recommended human dose
Lactation: It is not known whether secukinumab is excreted in human milk or absorbed systemically after ingestion. There are no data on the effects of secukinumab on the breastfed child or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for secukinumab and any potential adverse effects on the breastfed child from secukinumab or from the underlying maternal condition.
","Infections: Serious infections have occurred. Caution should be exercised when considering the use of secukinumab in patients with a chronic infection or a history of recurrent infection. If a serious infection develops, discontinue secukinumab until the infection resolves.
Tuberculosis (TB): Prior to initiating treatment with secukinumab, evaluate for TB.
Inflammatory Bowel Disease: Cases of inflammatory bowel disease were observed in clinical trials. Caution should be exercised when prescribing secukinumab to patients with inflammatory bowel disease.
Hypersensitivity Reactions: If an anaphylactic reaction or other serious allergic reaction occurs, discontinue secukinumab immediately and initiate appropriate therapy.
",,"Doses up to 30 mg/kg intravenously have been administered in clinical trials without dose-limiting toxicity. In the event of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
",,,"Secukinumab Sensoready pens, prefilled syringes and vials must be refrigerated at 2ºC to 8ºC. Keep the product in the original carton to protect from light until the time of use. Do not freeze. To avoid foaming do not shake. Secukinumab does not contain a preservative; discard any unused portion.
",11
+979,Secnidazole,secnidazole-979,https://medex.com.bd/attachments/e0DPSVwDc8XooGN8aBJGkeoLWoBVbx/secnidazole-prescribing-information,Amoebicides,Trichomoniasis,"Secnidazole is indicated in-
+
+- Intestinal Amoebiasis
+- Hepatic Amoebiasis
+- Urethritis and vaginitis due to Trichomonas vaginalis
+- Giardiasis
+
","Amoebicides, Anti-diarrhoeal Antiprotozoal
","Secnidazole is rapidly absorbed following oral administration. The maximum serum level is obtained after 3 hours following oral administration of 2 gm Secnidazole. The plasma elimination half-life is about 20 hours. The majority of Secnidazole is eliminated via urine (50% of the ingested dose is excreted within 120 hours). The pharmacokinetic profile of Secnidazole gives it the longest half-life of second-generation nitroimidazoles, ensuring 72-hour therapeutic blood levels from a 2 gm single dose.
","Secnidazole tablet should be administered orally. The dosage schedule of is mentioned below:
Acute Intestinal Amoebiasis:
+
+- Adults: 2 gm single dose, taken preferably just before meal.
+- Children: 30 mg/kg single dose, taken preferably just before meal.
+
+Asymptomatic Amoebiasis (minute& cystic form):
+
+- Adults: 2 gm once daily for only 3 days, taken preferably just before meal.
+- Children: 30 mg/kg once daily for only 3 days, taken preferably just before meal.
+
+Hepatic Amoebiasis: Evacuation of pus must be performed simultaneously with Secnidazole treatment at the suppurative stage of hepatic amoebiasis.
+
+- Adults: 1.50 gm/day in a single or divided doses, just before meal, for 5 days.
+- Children: 30 mg/kg/day, in a single or divided dose, just before meal, for 5 days.
+
+Giardiasis:
+
+- Adults: 2 gm single dose, taken preferably just before meal.
+- Children: 35-50 mg/kg single dose, taken preferably just before meal.
+
+Trichomoniasis:
+
+- Adults: 2 gm single dose, taken preferably just before meal. The partner should also receive the same treatment concomitantly.
+
",,"Administration of Secnidazole with disulfiram is not recommended: confusional state & paranoid reaction may occur.
Use of Secnidazole simultaneously with warfarin requires close monitoring: increased effect or oral anticoagulants and of the hemormagic risk is likely.
","Secnidazole is contra-indicated for those patients who are hypersensitive to imidazole derivatives.
","The clinical studies have shown that Secnidazole is characterized by very good tolerance and no serious adverse reactions have been reported to date. The following side-effects may be observed with Secnidazole as with all nitroimidazole derivatives & are rarely serious:
+
+- Most frequent side-effects: Gastrointestinal disturbances, nausea, epigastric pain, metallic taste, glossitis, stomatitis.
+- Occasional side effects: Urticaria, moderate leukopenia which is reversible on treatment discontinuation.
+- Rare side-effects: Vertigo, ataxia and motor incoordination, paresthesia, peripheral neuropathy. With Secnidazole, gastrointestinal disorders e.g. nausea, vomiting, eoigastric pain, etc., have been reported in very rare cases.
+
","Secnidazole may be prescribed in pregnancy after the first trimester. As with other similar drugs, Secnidazole should not be administered during the first trimester of pregnancy or during lactation because Secnidazoleis found in the placenta and breast milk.
","Patients should be advised not to take alcohol during treatment with Secnidazole (because of the possibility of antabuse effect). Administration of Secnidazoleshould be avoided to patients with a history of blood dyscrasia.
",,,,,"Store in a cool, dry place,protected from heat.
",10
+978,Saxagliptin,saxagliptin-978,https://medex.com.bd/attachments/6fPxJ2faMEMa8Ibtkmgc945EqEna8R/saxagliptin-prescribing-information,Dipeptidyl Peptidase-4 (DPP-4) inhibitor,Type 2 DM,"Monotherapy And Combination Therapy: Saxagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Limitation Of Use: Saxagliptin is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
","Dipeptidyl Peptidase-4 (DPP-4) inhibitor
","Saxagliptin inhibits dipeptidyl peptidase IV (DPP-IV) enzyme resulting in prolonged active incretin levels. It elevates the circulating levels of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) which stimulates insulin secretion in pancreatic β-cells in a glucose dependent manner. It improves glycaemic control by reducing fasting and postprandial plasma glucose concentration in patients w/ type 2 DM.
","Recommended Dosage: The recommended dosage of Saxagliptin is 2.5 mg or 5 mg once daily taken regardless of meals. Saxagliptin tablets must not be split or cut.
Dosage In Patients With Renal Impairment: No dosage adjustment for Saxagliptin is recommended for patients with mild renal impairment (CrCl >50 mL/min).
The dosage of Saxagliptin is 2.5 mg once daily (regardless of meals) for patients with moderate or severe renal impairment, or with end-stage renal disease (ESRD) requiring hemodialysis (CrCl ≤ 50 mL/min). Saxagliptin should be administered following hemodialysis. Saxagliptin has not been studied in patients undergoing peritoneal dialysis.
Because the dosage of Saxagliptin should be limited to 2.5 mg based upon renal function, assessment of renal function is recommended prior to initiation of Saxagliptin and periodically thereafter. Renal function can be estimated from serum creatinine using the Cockcroft-Gault formula or Modification of Diet in Renal Disease formula.
Dosage Adjustment With Concomitant Use Of Strong CYP3A4/5 Inhibitors: The dosage of Saxagliptin is 2.5 mg once daily when coadministered with strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitors (e.g., ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin)
Concomitant Use With An Insulin Secretagogue (e.g., Sulfonylurea) Or With Insulin When Saxagliptin is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to minimize the risk of hypoglycemia
","May be taken with or without food.
","Increased risk of hypoglycaemia with concomitant sulfonylureas, dose reduction may be necessary. Increased serum levels with CYP3A4/5 inhibitors (e.g. atazanavir, ketoconazole, nefazodone, ritonavir). Concomitant CYP3A4 inducers (e.g. carbamazepine, phenobarbital) may reduce the glycaemic lowering effect of saxagliptin.
","Type 1 diabetes, diabetic ketoacidosis.
","The following serious adverse reactions are described below or elsewhere in the prescribing information: Pancreatitis, Heart Failure, Hypoglycemia with Concomitant Use of Sulfonylurea or Insulin, Hypersensitivity Reactions, Severe and disabling arthralgia, Bullous pemphigoid
","Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
","Moderate and severe renal impairment. Pregnancy and lactation.
","Mild Renal Impairment: No dosage adjustment needed.
Moderate to Severe including with ESRD requiring hemodialysis: 2.5 mg once daily.
Hepatic Impairment No dosage adjustment.
",,,,"Store between 20-25° C.
",12
+1394,Saquinavir Mesylate,saquinavir-mesylate-1394,https://medex.com.bd/attachments/pcqWxxDSfZoowYZV9M3iVEDdtgIZHs/saquinavir-mesylate-prescribing-information,Anti-viral drugs,HIV infection,"Saquinavir is an HIV-1 protease inhibitor indicated for the treatment of HIV1 infection in combination with ritonavir and other antiretroviral agents in adults (over the age of 16 years)
","Anti-viral drugs
","Saquinavir is a protease inhibitor with activity against Human Immunodeficiency Virus Type 1 (HIV-1). Protease inhibitors block the part of HIV called protease. HIV-1 protease is an enzyme required for the proteolytic cleavage of the viral polyprotein precursors into the individual functional proteins found in infectious HIV-1. Saquinavir binds to the protease active site and inhibits the activity of the enzyme. This inhibition prevents cleavage of the viral polyproteins resulting in the formation of immature non-infectious viral particles. Protease inhibitors are almost always used in combination with at least two other anti-HIV drugs.
Saquinavir inhibits the HIV viral proteinase enzyme which prevents cleavage of the gag-pol polyprotein, resulting in noninfectious, immature viral particles.
","Saquinavir must be administered in combination with ritonavir.
Adults (over the age of 16 years): Saquinavir 1000 mg twice daily (5x200 mg capsules or 2x500 mg tablets) in combination with ritonavir 100 mg twice daily.
Saquinavir and ritonavir should be taken within 2 hours after a meal.
",,"Saquinavir/ritonavir is a potent inhibitor of CYP3A, significantly increasing the exposure of drugs primarily metabolized by CYP3A.
Coadministration of Saquinavir/ritonavir with drugs that induce CYP3A may result in decreased plasma concentrations of saquinavir and reduced efficacy.
Certain drugs or drug classes should not be coadministered with Saquinavir/ritonavir based on drug interaction studies or predicted drug interactions
","Patients with congenital or documented acquired QT prolongation, patients with refractory hypokalemia or hypomagnesemia, or those on concomitant therapy with other drugs that prolong the QT interval.
Saquinavir is contraindicated in patients with complete atrioventricular (AV) block without implanted pacemakers, or patients who are at high risk of complete AV block.
Saquinavir is contraindicated in patients with clinically significant hypersensitivity (e.g., anaphylactic reaction, Stevens-Johnson syndrome) to saquinavir, saquinavir mesylate, or any of its ingredients
Saquinavir when administered with ritonavir is contraindicated in patients with severe hepatic impairment.
Coadministration of Saquinavir/ritonavir with CYP3A substrates for which increased plasma levels may result in serious or life-threatening reactions.
Coadministration of Saquinavir/ritonavir with rifampin due to the risk of severe hepatotoxicity.
","The most common adverse reactions are nausea, vomiting, diarrhea, fatigue, pneumonia, lipodystrophy and abdominal pain
","Pregnancy: Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: Do not breastfeed if HIV-1-infected mothers are receiving Saquinavir therapy.
",,"Pediatric Use: Pediatric dose recommendations that are both reliably effective and below thresholds of concern with respect to QT and PR prolongation could not be determined
Geriatric Use: Caution should be exercised due to greater frequency of decreased hepatic, renal or cardiac function in elderly population.
Impaired Renal Function: No initial dose adjustment is necessary for patients with renal impairment.
Impaired Hepatic Function: No dose adjustment is necessary for patients with mild or moderate hepatic impairment.
",,,,"The capsules and tablets should be stored at 25 degree C
",10
+1875,Salvia Officinalis,salvia-officinalis-1875,,Miscellaneous topical agents,Intimate hygiene wash,"Preventive action in providing daily intimate hygiene, specific for the young and middle aged woman. Intimate care wash with Salvia officinalis. This is indicated for daily intimate hygiene.
","Miscellaneous topical agents
","Because it has a specific pH of 3.5 intimate wash with Salvia officinalis, it helps prevent alterations of the vaginal ecosystem, with deodorant actions.
",,,,"Hypersensitivity to the active substance or to any of the excipients.
",,,,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",5
+1283,Salsalate,salsalate-1283,,Drugs for Osteoarthritis,Rheumatoid arthritis,"Salsalate is indicated for relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and related rheumatic disorders, pain, fever and inflammation.
","Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","The mode of anti-inflammatory action of salsalate and other nonsteroidal anti-inflammatory drugs is not fully defined, but appears to be primarily associated with inhibition of prostaglandin synthesis. This inhibition of prostaglandin synthesis is done through the inactivation of cyclooxygenase-1 (COX-1) and COX-2, which are reponsible for catalyzing the formation of prostaglandins in the arachidonic acid pathway. Although salicylic acid (the primary metabolite of salsalate) is a weak inhibitor of prostaglandin synthesis in vitro, salsalate appears to selectively inhibit prostaglandin synthesis in vivo, providing anti-inflammatory activity equivalent to aspirin and indomethacin. Unlike aspirin, salsalate does not inhibit platelet aggregation.
","Adults: The usual dosage is 3000 mg daily, given in divided doses as follows:
+
+- Two doses of two 750 mg tablets
+- Two doses of three 500 mg tablets/capsules
+- Three doses of two 500 mg tablets/capsules
+
+Some patients, e.g., the elderly, may require a lower dosage to achieve therapeutic blood concentrations and to avoid the more common side effects such as auditory.
Alleviation of symptoms is gradual, and full benefit may not be evident for 3 to 4 days, when plasma salicylate levels have achieved steady state. There is no evidence for development of tissue tolerance (tachyphylaxis) but salicylate therapy may induce increased activity of metabolizing liver enzymes, causing a greater rate of salicyluric acid production and excretion, with a resultant increase in dosage requirement for maintenance of therapeutic serum salicylate levels.
Children: Dosage recommendations and indications for Salsalate use in children have not been established.
","Should be taken with food. Take with food or milk.
","May increase risk of liver damage when used with gold compounds. GI effects may be enhanced with alcohol or concurrent use with corticosteroids. May increase activity of coumarin anticoagulants, sulfonylureas, zafirlukast, methotrexate, phenytoin and valproate. May decrease the activity of probenecid and sulfinpyrazone.
","Haemophilia, haemorrhagic disorders, gout, hypersensitivity to aspirin or NSAIDs. Children <12 yr. Pregnancy (3rd trimester) and lactation. Severe renal or hepatic impairment.
","GI symptoms, hypersensitivity reactions, skin eruptions, angioedema, weakness, rhinitis and dyspnoea, hypoprothrombinaemia. Hepatotoxicity, renal impairment, iron-deficiency anaemia, occult bleeding. Local irritation (rectally); Reye's syndrome.
","Pregnancy Category C. Salsalate and salicylic acid have been shown to be teratogenic and embryocidal in rats when given in doses 4 to 5 times the usual human dose. The effects were not observed at doses twice as great as the usual human dose. There are no adequate and well-controlled studies in pregnantwomen. Salsalate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether salsalate per se is excreted in human milk; salicylic acid, the primary metabolite of Salsalate , has been shown to appear in human milk in concentrations approximating the maternal blood level. Thus, the infant of a mother on Salsalate therapy might ingest in mother†s milk 30 to 80% as much salicylate per kg body weight as the mother is taking. Accordingly, caution should be exercised when Salsalate is administered to a nursing woman.
","Peptic ulcers; asthma, allergic disorders. Impaired hepatic or renal function. Dehydrated patients; uncontrolled hypertension. May cause acute haemolytic anaemia in patients with G6PD deficiency.
",,"Symptoms: Tinnitus, vertigo, headache, confusion, drowsiness, sweating, hyperventilation, vomiting and diarrhea will occur. More severe intoxication will lead to disruption of electrolyte balance and blood pH, and hyperthermia and dehydration.
Treatment: Further absorption of Salsalate from the G.I. tract should be prevented by emesis (syrup of ipecac) and if necessary, by gastric lavage. Fluid and electrolyte imbalance should be corrected by the administration of appropriate I.V. therapy. Adequate renal function should be maintained. Hemodialysis or peritoneal dialysis may be required in extreme cases.
",,,,11
+977,Salmon Calcitonin,salmon-calcitonin-977,https://medex.com.bd/attachments/pei4cGTBiHVwskEMFq7hvrwPSVBJMB/salmon-calcitonin-injection-prescribing-information,Hormone in bone formation by Inhibiting bone resorption,Post-menopausal osteoporosis,"Salmon Calcitonin is indicated in Active Paget's disease in patients who do not respond to alternative treatments or for whom such treatments are not suitable; Hypercalcaemia.
","Hormone in bone formation by Inhibiting bone resorption
","Calcitonin is a polypeptide hormone produced by the ultimobranchial gland in non-mammalian vertebrates or by the mammalian thyroid parafollicular cells. It inhibits osteoclastic bone resorption and reduces bone turnover. It decreases tubular reabsorption and promotes renal excretion of Ca, Cl, Na, Mg, K and phosphate.
","Intravenous (Adult)-
+
+- Emergency treatment of hypercalcaemia: Up to 10 u/kg in 500 mL of sodium chloride 0.9% by slow IV infusion over at least 6 hr.
+
+Parenteral (Adult)-
+
+- Adjunct in hypercalcaemia: SC/IM: 4 u/kg 12 hrly, may increase after 1-2 days to 8 u/kg 12 hrly to max 8 u/kg 6 hrly after 2 days. Alternatively, 100 u every 6-8 hr, increased after 1-2 days to max 400 u every 6-8 hr.
+- Paget's disease of bone: SC/IM: 50 u 3 times wkly to 100 u/day.
+
+Nasal (Adult)-
+
+- Nasal postmenopausal osteoporosis: 200 u/day, alternation nostrils everyday.
+
",,"Concurrent use wth cardiac glycosides (e.g. digitalis) or Ca-channel blockers requires dosage adjustments of these drugs. May decrease serum concentration of lithium.
","Hypersensitivity. Patients with hypocalcaemia.
","GI disturbances, dizziness, flushing, tingling of the hands, unpleasant taste, skin rash, abdominal pain, urinary frequency, tremor, inj site inflammation. Rarely, diabetogenic effect.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Skin test should be done before initiating therapy. Heart failure; renal impairment. Pregnancy, lactation, childn.
","Renal Impairment: Dosage adjustment needed.
","Symptoms: Flushing, nausea, vomiting and dizziness.
Management: Symptomatic and supportive treatment.
",,,"Store between 2-8° C.
",12
+975,Salmeterol Xinafoate,salmeterol-xinafoate-975,https://medex.com.bd/attachments/6XkMpHaoKNf9HCOJhwoxnABBLiTmtb/salmeterol-xinafoate-prescribing-information,Long-acting selective β-adrenoceptor stimulants,COPD,"Inhaled Salmeterol exerts a significant bronchodilating effect within 10 to 20 minutes of single-dose administration with asthma and this effect lasts for up to 12 hours or more.
Salmeterol has a beneficial effect on airway mucociliary clearance that will reduce the incidence of respiratory ... Read more
Inhaled Salmeterol exerts a significant bronchodilating effect within 10 to 20 minutes of single-dose administration with asthma and this effect lasts for up to 12 hours or more.
Salmeterol has a beneficial effect on airway mucociliary clearance that will reduce the incidence of respiratory tract infections.
Salmeterol produces a significant protective effect against Exercise Induced Asthma (EIA) for up to 9 to 12 hours in both adolescents and adults.
Salmeterol improves the overnight PEFR (Peak Expiratory Flow Rate) and controls the symptoms of the patients with nocturnal asthma. The use of Salmeterol avoids exposure of children to theophylline or high-dose corticosteroid, with their attendants risks.
Addition of Salmeterol to inhaled corticosteroid therapy is significantly more effective in terms of an improvement in lung function, symptom control and a reduction in the use of rescue bronchodilator therapy (use of short acting beta2-agonist).
Addition of Salmeterol to inhaled corticosteroid therapy also significantly reduces the use of inhaled corticosteroids
","Long-acting selective β-adrenoceptor stimulants
","Salmeterol stimulates intracellular adenyl cyclase, the enzyme that catalyses the conversion of ATP to cyclic-3',5'-adenosine monophosphate (cAMP) resulting in relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from mast cells.
","Inhalation/Respiratory-
Chronic asthma:
+
+- Adult: As metered dose aerosol or dry powder inhaler: 50 mcg bid, or up to 100 mcg bid if necessary, in asthma patients with more severe airways obstruction.
+- Child: 4-12 yr 50 mcg bid.
+
+Prophylaxis of exercise-induced asthma:
+
+- Adult: As metered dose aerosol or dry powd inhaler: 50 mcg at least 30 min prior to exercise.
+- Child: ≥4 yr Same as adult dose.
+
+Chronic obstructive pulmonary disease:
+
+- Adult: As metered dose aerosol or dry powder inhaler: 50 mcg bid.
+
","Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.
Following simple steps can help to use Inhaler effectively (According to ""
National Asthma Guidelines for Medical Practitioners"" published by Asthma Association):
+
+- Take off the cap.
+- Shake the inhaler (at least six times) vigorously before each use.
+- If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
+- Breathe out as full as comfortably possible & hold the inhaler upright.
+- Place the actuator into mouth between the teeth and close lips around the mouthpiece.
+- While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
+- Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
+- If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
+- After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
+- Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.
+
+
Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.
","As with all the other beta2-agonists there may be interaction with betablocking agents at the receptor site when given concomitantly.
Monoamino Oxidase Inhibitors and Tricyclic Antidepressants : These agent should be used with caution because Salmeterol may be potentiated by these agents.
","Monotherapy in the treatment of asthma. Treatment of status asthmaticus, other acute episodes of asthma or COPD.
","Dose related tremor, subjective palpitations and headaches are usually mild and transient. Skin reactions, muscle cramps, non-specific chest pain, local irritation and arthralgia have been reported.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Patient with CV disease, CNS disorders, DM, hyperthyroidism, hypokalaemia, seizure disorders, ketoacidosis. Not intended for the relief of acute bronchospasm. Hepatic impairment. Pregnancy and lactation.
","Hepatic Impairment: Because Salmeterol is extensively metabolised by the liver, patients with hepatic impairment receiving the drug should be closely monitored.
","Symptoms: Dizziness, HTN or hypotension, tremor, headache, tachycardia, hypokalaemia, seizures, angina, arrhythmias, nervousness, muscle cramps, dry mouth, palpitations, nausea, fatigue, malaise, insomnia, hyperglycaemia, metabolic acidosis.
Management: Symptomatic and supportive treatment. β-blockers may be considered but should be used with caution.
",,,"Store between 20-25° C. Protect from heat or sunlight.
",13
+999,Sodium Dichloroisocyanurate,sodium-dichloroisocyanurate-999,,Water purifying agent,Water purification,"Effervescent water purification tablets make water safer by destroying harmful micro- organisms. It can also be used for washing fruits and vegetables and for cleaning teeth.
","Water purifying agent
","Sodium Dichloroisocyanurate is a disinfectant with the general properties of Chlorine and Sodium hypochlorite. It contains about 65% of available chlorine. It rapidly dissolves into water to kill micro-organisms.
","Sodium Dichloroisocyanurate 17 mg:
+
+- For drinking water: 1 (one) tablet to 1 (one) liter of water.
+- For fruits, vegetables washing water: 3 (three) tablets to 1 (one) liter of water.
+- Double the amount of tablets if the water is heavily contaminated. Leave for 15 (fifteen) minutes before use.
+
+Sodium Dichloroisocyanurate 51 mg:
+
+- For drinking water: 1 (one) tablet to 3 (three) liters of water.
+- For fruits, vegetables washing water: 3 (three) tablets to 3 (three) liters of water.
+- Double the amount of tablets if the water is heavily contaminated. Leave for 15 (fifteen) minutes before use.
+
",,"Store away from Calcium or Sodium hypochlorite. Store away from acids and compounds containing ammonia.
","Do not use with other products. It may release dangerous gases (chlorine). It may react violently with many substances, causing fire and explosion hazard.
","Skin contact: There may be irritation and redness at the site of contact. Repeated or prolonged contact may cause dermatitis.
Eye contact: There may be severe pain, redness and irritation.
Ingestion: There may be nausea and vomiting, occasionally with abdominal pain.
Inhalation: Mild poisoning causes cough, irritation of the throat and shortness of breath. Very toxic to aquatic organisms, may cause long term adverse effects in the aquatic environment.
","No data found
","Harmful if swallowed. If tablet is swallowed seek medical advice immediately. Keep away from other materials, especially from flammable materials. Slit off the tablets only before use.
",,,,,"Store in a cool & dry place, protected from light and moisture.
",10
+996,Sodium Cromoglicate + Xylometazoline Hydrochloride,sodium-cromoglicate-xylometazoline-hydrochloride-996,,Mast Cell Stabiliser,Rhinitis,"This Nasal Spray is indicated for the prophylaxis and treatment of allergic rhinitis (such as hay fever and perennial rhinitis) where this is accompanied by nasal congestion.
","Mast Cell Stabiliser
","Xylometazoline Hydrochloride is a sympathomimetic agent with alpha-adrenergic activity. It produces vasoconstriction thus reducing nasal congestion. This enables patients suffering from colds to breathe more easily through the nose.
Sodium Cromoglicate usually acts through a local effect on the nasal mucosa. It prevents release of the mediators of type-l allergic reactions, including histamine and slow reacting substance of anaphylaxis (SRS-A) from sensitized mast cells after the antigen-antibody union has taken place. The drug does not inhibit the binding of IgE and the specific antigen; instead it suppresses the release of substances (e.g., histamine, SRS-A) in response to this reaction. The drug also inhibits Type-III (late allergic, Arthers) reactions to a lesser extent.
","Adults (including the elderly) and children: One spray each nostril four times daily.
","How to use the Nasal Spray-
+
+- Shake the bottle gently and remove the dust cover.
+- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
+- Gently blow the nose to clear the nostrils.
+- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
+- Breathe out through your mouth.
+- Repeat the above steps in the same/ other nostril for consecutive doses.
+
+Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-
+
+- Remove the dust cover.
+- Gently pull off the nasal applicator.
+- Wash the applicator and dust cover in warm water.
+- Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
+- Gently push the applicator back on the top of the bottle and re-fix the dust cover.
+
",,"Contraindicated in patients with a known hypersensitivity to any ingredients of the preparation.
","No serious side effects have been reported. Occasional irritation of the nasal mucosa may occur during the first day of use. In rare cases with Sodium Cromoglicate solutions alone wheezing and tightness of the chest has been reported. Because a lower dose of Xylometazoline is employed in this preparation it causes mild side effects such as nasal irritation, dryness of the nose, sneezing, headache, insomnia, drowsiness and palpitations.
","As with all medicines, caution should be exercised during pregnancy especially during the first trimester.
","The prolonged use or abuse of decongestants in general may lead to rebound congestion or drug induced rhinitis.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+998,Sodium Cromoglicate [4%],sodium-cromoglicate-4-998,,Mast Cell Stabiliser,Rhinitis,"Ophthalmic use: Prevention of acute allergic conjunctivitis, seasonal conjunctivitis, vernal kerato conjunctivitis
Nasal use: It is also used for the symptomatic prevention & treatment of seasonal or perennial allergic rhinitis. Prophylactic treatment ... Read more
Ophthalmic use: Prevention of acute allergic conjunctivitis, seasonal conjunctivitis, vernal kerato conjunctivitis
Nasal use: It is also used for the symptomatic prevention & treatment of seasonal or perennial allergic rhinitis. Prophylactic treatment for seasonal allergic rhinitis should begin 2 to 3 weeks before exposure to the allergen and should continue throughout the season.
","Mast Cell Stabiliser, Ophthalmic Non-Steroid drugs
","Sodium Cromoglicate inhibits the degranulation of sensitized mast cells which occurs after exposure to specific antigens. Sodium Cromoglicate acts by inhibiting the release of histamine and various membrane derived mediators of inflammation from mast cells. Sodium Cromoglicate has no vasoconstrictor or antihistaminic activity.
","For eyes: For Child and Adult: 1 to 2 drops into each eye 2 to 3 times daily.
For nose: For Child and Adult: 1 drop to each nostril 2 to 3 times daily.
",,"No evidence of interaction with other drugs has been observed.
","This drop is contraindicated in patient with hypersensitivity to Sodium Cromoglicate .
","Transient stinging and burning may occur after instillation of this drops. Other symptoms of local irritation have been reported rarely.
","Sodium Cromoglicate should be used with caution during pregnancy and only if the expected benefit to the mother is greater than any possible risk to the fetus. There are no known harmful effects when this medicine is used by breastfeeding mothers.
","As this drop contains benzalkonium chloride, patients should not wear contact lenses during treatment with this drop.
",,"Overdose is unlikely. In the event of accidental ingestion, symptomatic treatment is recommended.
",,,"Store at room temperature and protect from light. Any remaining contents should be discarded 4 weeks after opening. Do not touch dropper tip to any surface since this may contaminate the solution.
",11
+997,Sodium Cromoglicate [2%],sodium-cromoglicate-2-997,https://medex.com.bd/attachments/2lU6hBwsCjrMxi6FKyUBUaGS2d7fbN/sodium-cromoglicate-2-prescribing-information,Mast Cell Stabiliser,Rhinitis,"Sodium Cromoglycate 2% Eye Drops is used for the prophylaxis and symptomatic treatment of certain allergic ocular disorders including vernal kerato conjunctivitis, vernal conjunctivitis, giant papillary conjunctivitis, vernal keratitis and allergic keratoconjunctivitis. Ophthalmic administration of ... Read more
Sodium Cromoglycate 2% Eye Drops is used for the prophylaxis and symptomatic treatment of certain allergic ocular disorders including vernal kerato conjunctivitis, vernal conjunctivitis, giant papillary conjunctivitis, vernal keratitis and allergic keratoconjunctivitis. Ophthalmic administration of Sodium Cromoglycate 2% Eye Drops generally provides symptomatic relief of itching, tearing, redness and discharge within a few days following initiation of therapy; however, up to 6 weeks of therapy may be required for optimum symptomatic relief in some patients. Once symptomatic improvement has been established therapy should be continued for as long as needed to sustain improvement.
","Mast Cell Stabiliser, Ophthalmic Non-Steroid drugs
","Sodium Cromoglycate 2% sterile Eye Drops inhibits the release of chemical mediators from sensitised mast cells and is capable of rapid phosphorylation of mast cell protein. The exact mechanism of action of the drug remains to be elucidated but Sodium Cromoglycate appears to modulate the allergic response to antigen antibody interactions in a way which prevents the subsequent formation or release of toxic or inflammatory mediators. Sodium Cromoglycate 2% Eye Drops appears to act mainly through a local effect on the mucous of the eye. Approximately 0.03% of an ophthalmic dose of Sodium Cromoglycate 2% Eye Drops is absorbed systemically. Sodium Cromoglycate 2% Eye Drops prevent, release of mediators of type-I allergic reactions, including histamine and slow reacting substance of anaphylaxis (SRS-A) from sensitised mast cells after the antigen antibody union has taken place. The drug does not inhibit the binding of IgE to mast cells nor the interaction between cell bound IgE and the specific antigen; instead Sodium Cromoglycate suppresses the release of substances (e.g. histamine, SRS-A) in response to this reaction. The drug also inhibits Type-III (late allergic, Arthus) reactions.
","The usual dosage of Sodium Cromoglycate 2% Eye Drops in adults and children over 4 years of age or older is 1 or 2 drops in each eye 4-6 times daily at regular intervals. The recommended frequency of administration should not be exceeded. Patients should be advised that the therapeutic effects of Sodium Cromoglycate 2% Eye Drops depend on administration of the drug at regular intervals.
",,"Sodium Cromoglycate has no known drug interactions.
","Sodium Cromoglycate 2% Eye Drops is contraindicated in individuals who have shown hypersensitivity to the drug or any of the ingredients.
","The most frequent adverse effect reported with use of Sodium Cromoglycate 2% Eye Drops is transient ocular stinging or burning upon instillation of the drug.
","In animal studies, Sodium Cromoglycate has produced adverse effects on the foetus only in high parenteral doses. There was no evidence of impaired fertility in reproduction studies in animals. Healthy infants have been born to women who received Sodium Cromoglycate throughout pregnancy; nevertheless, there is insufficient evidence to establish the safety in pregnancy. It should be used during pregnancy only when clearly needed. Since it is not known if Sodium Cromoglycate is distributed into milk in humans, the drug should be used with caution in nursing women.
","Sodium Cromoglycate 2% Eye Drops contains benzalkonium chloride and patients should be advised not to wear soft contact lenses during treatment with Sodium Cromoglycate 2% Eye Drops.
",,"Overdose is unlikely. In the event of accidental ingestion, symptomatic treatment is recommended.
",,,"Sodium Cromoglycate 2% Eye Drops should be protected from direct sunlight and stored at a temperature less than 30˚C; any unused ophthalmic solution should be discarded 4 weeks after opening the cap of the bottle.
",11
+1435,Sodium Chloride + Potassium Chloride + Sodium Acetate,sodium-chloride-potassium-chloride-sodium-acetate-1435,,Electrolytes preparations,Vomiting,"Cholera, Diarrhea, Severe vomiting and fluid loss due to excessive sweating
","Electrolytes preparations
",,"The volume and rate of infusion of Cholera Saline depends upon the requirements of the patient and the judgment of the physician. It usually varies with age, weight and clinical condition of the patient.
",,,,,,,,,,,,3
+351,Sodium Chloride + Dextrose,sodium-chloride-dextrose-351,https://medex.com.bd/attachments/5WV4ofZMlZvSw2KTXWYULAqnXphcWU/sodium-chloride-dextrose-prescribing-information,Parenteral nutritional preparations,Fluid and electrolyte imbalance,"This solution is indicated when there is combined water and sodium depletion. It provides Dextrose as a nutrient in a suitable medium of Sodium Chloride which is isotonic to body fluid, or it may also be employed as a source of isotonic Sodium Chloride or both. It is usually used in the maintenance ... Read more
This solution is indicated when there is combined water and sodium depletion. It provides Dextrose as a nutrient in a suitable medium of Sodium Chloride which is isotonic to body fluid, or it may also be employed as a source of isotonic Sodium Chloride or both. It is usually used in the maintenance and replacement of fluid, electrolyte and carbohydrate in patients who are unable to take fluid and nutrients by mouth e.g. in case of persistent vomiting, during and after surgery, shock or accidents.
","Intravenous fluid preparations, Parenteral nutritional preparations
",,"Dose is variable. It depends on the clinical condition, age and body surface area of the patients.
","
+- Check infusion set and infusion solution prior to use.
+- Pull moderately to tear off the protective cover of the Eurocap.
+- Hold lightly the Eurocap but not the bottle body.
+- Open the flow regulator fully and hold the giving set on the top white area, but not the memorane venting region.
+- Insert the spike of the administration set to the Eurocap and fit the connector of the administration set firmly to the needle.
+- Gradually allow the fluid to flow down to the needletip and close.
+- Remove the protective cover of the needle.
+- Locate the venpuncture site and clean the site with an antiseptic solution, and then insert the needle.
+- Securely tape the puncture site.
+- Securely tape the wings and tubing
+- Start infusion while adjusting drip speed.
+
",,"Do not take this medicine and tell your doctor if: Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.
","Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
","FDA pregnancy category C. It is not known whether dextrose 5% in water will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether dextrose 5% in water passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
","As the preparation contains Sodium Chloride, it should be administered with caution to patients with congestive heart failure, peripheral or pulmonary oedema, impaired renal function or pre-eclampsia. Serum glucose concentration should also be carefully monitored and concurrent use of insulin may be needed in case of diabetic patients. Infusion of fluid should be immediately discontinued if rigor arises for any reason during the process. Do not use if the solution is cloudy, contains particles, or after expiry date.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+1678,Sodium Chloride (Tablet),sodium-chloride-tablet-1678,,Oral electrolytes preparations,Sodium Chloride deficiency,"For the treatment and prophylaxis of Sodium Chloride deficiency.
","Oral electrolytes preparations
","Sodium chloride is the principle salt involved in maintaining the osmotic tension of blood and tissues, changes in osmotic tension influence the movement of fluids and diffusion of salts in cellular tissue. Sodium Chloride tablet provides a source of sodium where a deficiency exists. Sodium chloride is readily absorbed from the gastro-intestinal tract. It is present in all body fluids but specially in the extracellular fluid. The amount of sodium lost (as sweat) is normally small. Osmotic balance is maintained by excretion of surplus amounts in the urine.
","It is important that the tablet should be swallowed whole with water (approx. 70 ml per tablet where kidney function is normal to avoid hypernatremia), and not chewed.
Adults: For prophylaxis 8-16 tablets per day. For treatment dosage to be adjusted to individual needs up to a maximum of 40 tablets per day in case of severe salt depletion. For control of muscle cramps during routine maintenance haemodialysis usually 20-32 tablets per dialysis. In some cases of chronic renal salt-wasting, up to 40 tablets per day may be required with appropriate fluid intake.
Children: Dosage should be adjusted to individual needs.
Elderly: No special dosage adjustment.
",,"In hypertensive patients with chronic renal failure Sodium Chloride, 300 mg tablet may tend to impair the efficacy of antihypertensive drugs.
","Sodium Chloride is contra-indicated in any situation where salt retention is undesirable, such as edema, heart disease, cardiac decompensation and primary or secondary aldosteronism; or where therapy is being given to produce salt and water loss.
","No side effects have been reported with Sodium Chloride 300 mg tablet at the recommended dosage.
","Use in Pregnancy: No additional precautions required during pregnancy.
","No special warnings and precautions are required to maintain.
",,"Signs and symptoms: Excessive intake of sodium chloride can result in hypernatraemia. Symptoms of hypernatraemia include restlessness, weakness, thirst, reduced salivation and lachrymation, swollen tongue, flushing of the skin, pyrexia, dizziness, headache, oliguria, hypertension, tachycardia, delirium, hyperpnoea and respiratory arrest.
Treatment: Treatment requires the use of sodium-free liquids and the cessation of excessive sodium intake. In the event of a significant overdose serum sodium levels should be evaluated as soon as possible and appropriate steps taken to correct any abnormalities. The use of a loop diuretic e.g. frusemide (with potassium supplementation as required) may be appropriate in severe cases of hypernatraemia. Levels should be monitored until they return to normal.
",,,"Store below 30°C in a dry place protected from light. Keep out of reach of Children.
",11
+1545,Sodium Chloride (Ophthalmic Solution),sodium-chloride-ophthalmic-solution-1545,,Other ophthalmic preparations,Pain or swelling of the cornea,"This medication is used to reduce swelling of the cornea in certain eye conditions.
","Other ophthalmic preparations
","5% Sodium chloride ophthalmic solution is a hypertonic preparation. It is used to reduce the edema or swelling of the cornea. This solution exerts its effect through using the tonicity difference.
","Instill 1 or 2 drops in the affected eye(s) every 3 or 4 hours, or as directed by a physician.
",,,"It is contraindicated in individuals with known hypersensitivity to any of the ingredients of this preparation.
","Vision may be temporarily blurred or unstable for a period after applying the drops. Use caution if driving or performing duties requiring clear vision. Burning or irritation of the eye may occur when first applied. If these symptoms continue or become worse, inform your doctor. Notify your doctor immediately if you develop: redness, pain, swelling in or around the eyes, vision problems, sensitivity to light, headache. If you notice other effects not listed above, contact your doctor or pharmacist.
",,"Tell your doctor if you have history of eye problems, any allergies. As with any medication, this should be used cautiously during pregnancy or while breast-feeding. Discuss the risks and benefits with your doctor. If the condition for which this was prescribed does not improve or becomes worse after a few days, Stop using and consult your doctor.
If you miss a dose, use it as soon as remembered; do not use it if it is near the time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. Do not ""double-up"" the dose to catch up.
",,,,,"Store in a cool and dry place, away from light. Keep out of reach of children.
",8
+995,Sodium Chloride (Nasal preparation),sodium-chloride-nasal-preparation-995,,Nasal Decongestants & Other Nasal Preparations,Pain or swelling of the cornea,"Sodium Chloride nasal wash is indicated for dry nasal membranes including dry nose resulting from cold and allergy medications. It moistens dry nasal passages from dry climates or from airplane travel, may help dissolve mucus from study noses and clears the nose after surgery. This sterile saline solution ... Read more
Sodium Chloride nasal wash is indicated for dry nasal membranes including dry nose resulting from cold and allergy medications. It moistens dry nasal passages from dry climates or from airplane travel, may help dissolve mucus from study noses and clears the nose after surgery. This sterile saline solution is also used to cleanse various parts of the body (wounds, body cavities) and medical equipment (e.g. bandages, catheters, drainage tubes). It is also used as a mixing solution (diluent) for other medications used to irrigate the body (e.g. bacitracin, polymyxin).
","Nasal Decongestants & Other Nasal Preparations
","Sodium Chloride nasal wash is a non-drug, isotonic saline solution that is used to moisturize nasal membranes. This formulation provides comfort for extensive and continuous use.
Sodium Chloride 0.9% nasal wash moistures inside the nose by dissolving and softening thick or crusty mucus thus helps to remove the mucus from the nose and makes breathing easier. Excess sodium is predominantly excreted by the kidneys with small amounts lost in faeces and sweat.
","Nasal Congestion: In infants, 1-2 drops of Sodium Chloride nasal wash in each nostril before feeds will help relieve congestion and allow more effective suckling.
Ear Wax Removal: Allow the Sodium Chloride nasal wash to warm to room temperature before use. It is important to put the drops into the ear carefully. Lie down on one side and fill the ear canal with the drops and wait for a few minutes before standing up. Age: from 6 months onwards. Put 3 to 4 drops into the affected ear(s) 3 to 4 times a day for 3 to 5 days.
","How to use the Nasal Spray-
+
+- Shake the bottle gently and remove the dust cover.
+- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
+- Gently blow the nose to clear the nostrils.
+- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
+- Breathe out through your mouth.
+- Repeat the above steps in the same/ other nostril for consecutive doses.
+
+Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-
+
+- Remove the dust cover.
+- Gently pull off the nasal applicator.
+- Wash the applicator and dust cover in warm water.
+- Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
+- Gently push the applicator back on the top of the bottle and re-fix the dust cover.
+
",,"Do not share this medication with others. Doing so may increase the risk of infection.
","No side effects are expected to occur. However stinging, sneezing, increased nasal discharge, or salty taste may occur in some cases.
","Tell your doctor if you are pregnant before using this medication. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
","Tell your doctor about your medical history, especially of heart problems (e.g., congestive heart failure), lung problems (pulmonary edema), kidney problems, low levels of potassium (hypokalemia), high levels of sodium (hypernatremia), and any allergies.
",,"There have been no adverse reports of overdose with Sodium Chloride 0.9% nasal wash.
",,,"Keep out of the reach of children. Store at room temperature (between 15°C to 30°C), away from light and moisture.
",11
+1352,Sodium Chloride (Intravenous Solution),sodium-chloride-intravenous-solution-1352,https://medex.com.bd/attachments/IRCThBPKO7Ieh64pRv13ZSEV7TK6JH/sodium-chloride-intravenous-solution-prescribing-information,Intravenous fluid preparations,Metabolic alkalosis,"Sodium Chloride is a sterile solution of Sodium Chloride in water for injection. Each 100 ml solution contains Sodium Chloride B.P. 0.9 gm. Isotonic (0.9% w/v) Sodium Chloride infusion is used in sodium and water depletion.
For instance, in the management of metabolic alkalosis, in case ... Read more
Sodium Chloride is a sterile solution of Sodium Chloride in water for injection. Each 100 ml solution contains Sodium Chloride B.P. 0.9 gm. Isotonic (0.9% w/v) Sodium Chloride infusion is used in sodium and water depletion.
For instance, in the management of metabolic alkalosis, in case of gastro-enteritis, during and after surgery. It may also be used as a priming fluid for haemodialysis procedures. Sodium Chloride 0.9% infusion is often used as diluents for infusion of drug additives etc. It is widely used for sterile irrigation and dilution process.
","Intravenous fluid preparations
",,"The concentration and dosage of Sodium Chloride solution for intravenous use is determined by several factors including age, weight and clinical condition of the patient. Usually, the adult dose is about 1000 ml of 0.9% injection.
","
+- Check infusion set and infusion solution prior to use.
+- Pull moderately to tear off the protective cover of the Eurocap.
+- Hold lightly the Eurocap but not the bottle body.
+- Open the flow regulator fully and hold the giving set on the top white area, but not the memorane venting region.
+- Insert the spike of the administration set to the Eurocap and fit the connector of the administration set firmly to the needle.
+- Gradually allow the fluid to flow down to the needletip and close.
+- Remove the protective cover of the needle.
+- Locate the venpuncture site and clean the site with an antiseptic solution, and then insert the needle.
+- Securely tape the puncture site.
+- Securely tape the wings and tubing
+- Start infusion while adjusting drip speed.
+
",,,"Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
","Pregnancy Category C. Animal reproductive studies have not been conducted with Sodium Chloride Injection USP 0.9%. It is also not known whether Sodium Chloride Injection USP 0.9% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Injection USP 0.9% should be given to a pregnant woman only if clearly needed.
","Serum electrolyte concentration should be carefully monitored. Sodium Chloride should be administered with caution to patients with congestive heart failure, peripheral or pulmonary oedema, impaired renal function or pre-eclampsia. Care should also be taken when administering Sodium Chloride intravenously to very young or elderly patients. Excessive administration should be avoided as this may result in hypokalaemia. Infusion of fluid should be immediately discontinued if rigor arises for any reason during its application. Do not use if the solution is cloudy, contains particles, or after expiry date.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",8
+992,Sodium Bicarbonate,sodium-bicarbonate-992,,Intravenous fluid preparations,Urine alkalinisation,"Management of acidosis in cardiac arrest.
Management of metabolic acidosis in:
+
+- Severe renal disease
+- Uncontrolled diabetes
+- Circulatory insufficiency from shock or dehydration
+- Severe primary lactic acidosis
+
+Alkalinization of urine.
","Intravenous fluid preparations, Urinary Alkalinizing Agent
","Sodium bicarbonate is a systemic alkalinizing agent. It increases plasma bicarbonate, buffers excess hydrogen ion concentration, and raises blood pH, thereby reversing the clinical manifestations of acidosis. It can also be used to replenish electrolyte imbalance as a treatment adjunct for severe diarrhea where the loss of bicarbonate can be significant.
","Oral: The usual dose is 300 mg to 2 grams, 1 to 4 times daily.
Intravenous (Severe metabolic acidosis):
+
+- Adult: By slow inj of a hypertonic solution of up to 8.4% (1000 mmol/L), or by continuous infusion of a weaker solution, usually 1.26% (150 mmol/L). For correction of acidosis during advanced cardiac life support procedures, 50 ml of an 8.4% solution may be given.
+- Elderly: Dosage adjustments may be required.
+
",,"This medication has the potential to interact with many medications. Should not take any other medication within 1 to 2 hours of taking an antacid. Potentially hazardous interactions with Corticosteroids and Corticotropin, Alkalis, Calcium, Diuretics and Potassium.
","This drug is contraindicated in hypoventilatory states, chloride depletion owing to continuous gastric fluid loss, metabolic and/or respiratory alkalosis, hypocalcemia and diuretics known to produce hypochloremic alkalosis.
","This medication is generally well tolerated. However, high doses may cause headache, nausea or irritability. If any of these effects continue or become bothersome, inform your doctor. Notify your doctor if you develop: muscle weakness, slow reflexes, confusion, swelling of the feet or ankles, black tar-like stools, coffee-ground vomit. If you notice other effects not listed above, contact your doctor or pharmacist.
","Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Pre-existing heart disease, kidney disease, liver disease, high blood pressure, any allergies.
","Renal Impairment: Dosage adjustments may be required.
Hepatic Impairment: Dosage adjustments may be required.
","If alkalosis results, the bicarbonate should be stopped and the patient managed according to the degree of alkalosis present. 0.9% sodium chloride injection intravenous may be given; potassium chloride also may be indicated if there is hypokalemia. Severe alkalosis may be accompanied by hyperirritability or tetany and these symptoms may be controlled by calcium gluconate. An acidifying agent such as ammonium chloride may also be indication in severe alkalosis.
",,,"Store in a cool & dry place protected from light. Keep out of reach of children.
",12
+1451,Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate,sodium-alginate-sodium-bicarbonate-calcium-carbonate-1451,https://medex.com.bd/attachments/IIrey4oCvxJ8Pj66YMbz9pKy24jHiR/sodium-alginate-sodium-bicarbonate-calcium-carbonate-prescribing-information,Antacids,,"This preparation is indicated in Gastric reflux, Heartburn, Flatulence associated with gastric reflux, Heartburn of pregnancy, All cases of epigastric and retrosternal distress where the underlying cause is gastric reflux.
","Antacids
","The mode of action of the product is physical and does not depend on absorption into the systemic circulation. On ingestion, the product reacts rapidly with gastric acid to form a raft of Alginic acid gel having a near-neutral pH and which floats on the stomach contents quickly and effectively impeding gastro-esophageal reflux, for up to 4 hours. In severe cases, the raft itself may be refluxed into the esophagus in preference to the stomach contents and exert a demulcent effect.
","For oral administration:
Adult and children over 12 years:10-20 mL after meals and at bedtime, up to four times a day.
Children 6 to 12 years: 5-10 mL after meals and at bedtime, up to four times a day.
Children under 6 years: Not recommended.
Elderly: No dosage modification is required for this age group.
",,"A time-interval of 2 hours should be considered between this drug intake and the administration of other medicinal products, especially Tetracyclines, Digoxine, Fluoroquinolone, Iron salt, Ketoconazole, Neuroleptics, Thyroid Hormones, Penicillamine, beta-blockers (Atenolol, Metoprolol, Propranolol), Glucocorticoid, Chloroquine and Biphosphonates (diphosphonates) and Estramustine.
","This product is contraindicated in patients with known or suspected hypersensitivity to the active ingredients or to any of the excipients.
","In addition to the desired effect of the drug, some side effects may appear such as: constipation, flatulence, stomach cramp or belching. In these cases consult a physician. If too big dose has been taken, there might appear a sensation of swelling. In this case, it is advisable to consult a physician.
","Pregnancy: Clinical studies in more than 500 pregnant women, as well as a large amount of data from post-marketing experience, indicate no malformative nor feto/neonatal toxicity of the active ingredients. This drug can be used during pregnancy, if clinically needed.
Breastfeeding: No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. This drug can be used during breastfeeding.
Fertility: Pre-clinical investigations have revealed Alginate has no negative effect on parental or offspring fertility or reproduction. Clinical data do not suggest that this drug has an effect on human fertility.
","If symptoms do not improve after 7 days, the clinical situation should be reviewed. Each 10 mL dose has a Sodium content of 141 mg (6.2 mmoL). This should be taken into account when a highly restricted salt diet is recommended, e.g. in some cases of congestive cardiac failure and renal impairment. Each 10 mL dose contains 160 mg (1.6 mmoL) of Calcium Carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
",,"In the event of over dosage symptomatic treatment should be given. The patient may notice abdominal distension.
",,,"Store in a cool (below 30°C) and dry place, away from light. Keep out of the reach of children. Do not refrigerate or freeze.
",11
+903,Sodium Alginate + Potassium Bicarbonate,sodium-alginate-potassium-bicarbonate-903,,Antacids,,"This preparation is indicated for the treatment of symptoms resulting from the reflux of acid, bile and pepsin into the esophagus such as acid regurgitation, heartburn, indigestion for instance, after gastric surgery, as a result of hiatus hernia, during pregnancy, accompanying reflux esophagitis, including ... Read more
This preparation is indicated for the treatment of symptoms resulting from the reflux of acid, bile and pepsin into the esophagus such as acid regurgitation, heartburn, indigestion for instance, after gastric surgery, as a result of hiatus hernia, during pregnancy, accompanying reflux esophagitis, including symptoms of laryngopharyngeal reflux such as hoarseness and other voice disorders, sore throats and cough. This preparation can also be used to treat the symptoms of gastroesophageal reflux during concomitant treatment with or following the withdrawal of acid suppressing therapy.
","Antacids
","This is the combination of Sodium Alginate and Potassium Bicarbonate. Sodium Alginate is a naturally occurring substance. It reacts with the acid in the stomach to form a gel. Potassium Bicarbonate also reacts with the acid in the stomach to form bubbles of carbon dioxide. These bubbles are trapped by the gel formed by Sodium Alginate and they allow the gel to float like a raft on top of the stomach contents. The raft prevents acid in the stomach from flowing back into the esophagus. This relieves the symptoms of reflux such as heartburn. The mode of action of this is physical and does not depend on absorption into the systemic circulation. The raft lasts for up to 4 hours on top of the stomach contents and is then broken down in the digestive system and excreted in the feces.
","Tablet:
+
+- Adults and children over 12 years: 1-2 tablets 3-4 times daily, after meals and before bedtime.
+- Children 6-12 years: ½-1 tablet 3-4 times daily, after meals and before bedtime.
+
+Suspension:
+
+- Adults and children 12 years and above: 5-10 ml (1-2 teaspoonfuls) 3-4 times daily, after meals and before bedtime.
+- Children 2-12 years: 2.5-5ml (½-1 teaspoonful) 3-4 times daily, after meals and before bedtime.
+
+
Use in children: This is not recommended under 2 years of age.
Elderly: No dose modifications are necessary for this age group.
Hepatic Impairment: No dose modifications are necessary.
Renal Insufficiency: Caution if a highly restricted salt diet is necessary.
",,"A time interval of 2 hours should be considered between this intake and the administration of other medicinal products, especially tetracyclines, fluoroquinolones, iron salts, thyroid hormones, chloroquine, bisphosphonates, and estramustine.
","Sodium alginate and potassium bicarbonate is contraindicated in patients with known hypersensitivity to these.
","In addition to the desired effect of the drug, some side effects may appear such as: nausea, constipation, diarrhea or headache. In these cases consult a physician In case too big dosage has been taken, there might appear a sensation of swelling. In this case it is advisable to consult a physician.
","This combination (Sodium Alginate and Potassium Bicarbonate) can be used during pregnancy, if clinically needed. No known effect on breast-fed infants. This combination can be used during breastfeeding.
","Sodium Alginate and Potassium Bicarbonate should be prescribed with caution in patients with renal impairment and congestive cardiac failure. Care needs to be taken in treating patients with hypercalcemia, nephrocalcinosis and recurrent calcium-containing renal calculi. There is a possibility of reduced efficacy in patients with very low levels of gastric acid. If symptoms do not improve after seven days, the clinical situation should be reviewed.
",,"Overdosage with this formulation is a rare case. In case of overdose please consult with a registered physician.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+991,Snake Venom Antiserum,snake-venom-antiserum-991,,"Vaccines, Anti-sera & Immunoglobulin",Envenomation caused by snake bites,"Snake Venom Antiserum is indicated for bites caused by Cobra, Common Krait, Russell's Viper and Saw-Scaled Viper, where the patient presents with one or more of fallowing visible clinical signs and symptoms of envenomation –
Local envenomation-
+
+- Presence of bite marks with or without oozing of blood, blistering and change in color of skin.
... Read more
Snake Venom Antiserum is indicated for bites caused by Cobra, Common Krait, Russell's Viper and Saw-Scaled Viper, where the patient presents with one or more of fallowing visible clinical signs and symptoms of envenomation –
Local envenomation-
+
+- Presence of bite marks with or without oozing of blood, blistering and change in color of skin.
+- Rapidly progressive or massive swelling involving more than half of the bitten limb within few hours of bite (without tourniquet)
+- Development of enlarged tender lymph nodes draining the bitten part within couple of hours after bite
+
+Systemic envenomation-
+
+- Neurotoxic syndrome- signs of neuro-paralysis like blurring of vision, double vision, and difficulty in swallowing, sleepy feeling, drooping of head, slurring of speech and the voice may become indistinct with shallow breathing, ptosis, ataxia, respiratory paralysis and generalized flaccid paralysis.
+- Hemotoxic syndrome- spontaneous systemic bleeding, nausea, vomiting, abdominal pain and abdominal tenderness suggestive of gastro-intestinal or retro-peritoneal bleed and/or renal damage, coagulopathy detected by 20 min WBCT with or without external bleeding and shock.
+
+
Immediate actions and first aid: Quick and positive measures should be taken to meet the emergency. Do not try to catch or kill the snake without proper tools and avoid unnecessary exposure to snack. Patient should be removed to a well-ventilated and quiet place and restrict his/her movement. Patient should be reassured to overcome fear. Immobilize the bitten part by applying immobilization bandage as done for a fracture and bitten part is kept below heart level. Ligation by applying tourniquets should be avoided, however, if applied it should be tied at moderate distance above the bitten part to prevent the entry of venom into the circulation. Patient should be immediately taken to nearby medical centre for treatment without loss of time.
","Vaccines, Anti-sera & Immunoglobulin
","Snake venom antiserum is a sterile preparation containing antitoxin globulins and their derivatives. It is the only specific treatment for venomous snake bites.
","As of now Snake venom antiserum is the only specific antidote for snake envenomation and prompt administration of adequate dose of Antiserum is of paramount importance for neutralization of unbound circulating snake venom components for early response to treatment. Any delay in administration may result in increased dose requirement and decreased effectiveness. As the clinical signs can vary due to many factors such as type of snake, time of reporting after bite, size of snake, amount of venom injected during bite, seasonal & regional variation in venom composition etc., no accurate dosage can be recommended.
However, considering the average quantity of venom injected by snake at the time of bite and degree of envenomation, it is recommended to administer initial dose of 5-10 vials of Snake venom antiserum by slow intravenous infusion either undiluted at a speed of not more than 2 ml per minute or after dilution with Normal /glucose saline at a rate of 5-10 ml/kg body weight over one hour. Children should receive the same dose as adults. Constant monitoring of the vital signs at frequent intervals during initial 1 hour is recommended. Requirement of further dosing depends on extent of reversal of coagulopathy confirmed after 6 hours of Antiserum administration by WBCT in haemotoxic bite or if symptoms persist or worsen or in respiratory failure in neurotoxic bite after 1 hour of Antiserum administration.
If the blood is still in coagulable or no signs of reversal of paralysis are seen, a further dose of 5 to 10 vials of Antiserum should be administered by slow IV route only. Administration by IM or locally around the bite wound is not recommended. In the majority of cases of both neurotoxic and haemotoxic bites, total dose of 15-20 vials is adequate unless a proven recurrence of envenomation is established. In such a scenario, further doses can be given as per clinical condition of the patient. Hypersensitivity skin test has no predictability value and hence should not be used.
",,"Risk of increased severity of acute anaphylaxis when used with β-adrenergic blockers.
","There are no known contraindications for the administration of Snake venom antiserum. Proper precautions are necessary while dealing with persons with a known hypersensitivity to constituents of product. Few doctors prefer to premedicate patients with Inj. Adrenaline 0.25 ml s/c to prevent possibility of adverse reactions. In haemotoxic bites, IM injections should be avoided till correction of coagulopathy to avoid formation of haematoma and oozing of blood. In patients having tourniquet, it should be released slowly only after start of Snake venom antiserum administration.
","Snake venom antiserum being derived from equines is heterologous to human can give either early or late reaction. Adrenaline should be always kept handy, before starting the dose of Snake venom antiserum. Reduction in adverse reactions has been reported by use of adequate dilution of Snake venom antiserum with saline and controlling rate of infusion.
","Considering the risk associated with snake bite envenomation, pregnancy is not a contraindication for the administration of Snake Venom Antiserum subsequent to bite.
","Proper skin test should be done prior to parenteral admin of the antivenom to identify risk of anaphylaxis.
",,,,"To reconstitute the Snake Venom Antiserum, transfer content of supplied diluents into the vial containing lyophilized preparation. Mix the contents gently by swirling action and avoid vigorous shaking. Serum should be used as soon as possible after reconstitution.
","Lyophilized Snake venom antiserum is stable at room temperature and does not require special storage facilities. Ideally, it should be stored in a cool & dark place and do not expose to excessive heat.
",11
+737,Sitagliptin + Metformin Hydrochloride,sitagliptin-metformin-hydrochloride-737,https://medex.com.bd/attachments/QTAJCA95nAZDnIKFv20vRsoihejX52/sitagliptin-metformin-hydrochloride-prescribing-information,Combination Oral hypoglycemic preparations,Type 2 DM,"This is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate. Important limitations of use:
+
+- This should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be efective in these settings.
... Read more
This is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate. Important limitations of use:
+
+- This should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be efective in these settings.
+- This has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using This.
+
","Combination Oral hypoglycemic preparations
","This tablet combines two antihyperglycemic agents with complementary mechanisms of action to improve glycemic control in patients with type 2 diabetes. Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and Metformin HCl, a member of the biguanide class. Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, which is believed to exert its actions in patients with type 2 diabetes by slowing the inactivation of incretin hormones. Incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the intestine throughout the day, and levels are increased in response to a meal. These hormones are rapidly inactivated by the enzyme, DPP-4. The incretins are part of an endogenous system involved in the physiologic regulation of glucose homeostasis. When blood glucose concentrations are normal or elevated then GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells by intracellular signaling pathways involving cyclic AMP. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, leading to reduced hepatic glucose production. By increasing and prolonging active incretin levels, Sitagliptin increases insulin release and decreases glucagon levels in the circulation in a glucose-dependent manner. The pharmacologic mechanism of action of Metformin HCl is different from other classes of oral antihyperglycemic agents. Metformin HCl decreases hepatic glucose production, decreases intestinal absorption of glucose and increases peripheral glucose uptake and utilization.
","Dose of film-coated tablet: The dosage of this tablet should be individualized on the basis of the patient's current regimen, efectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin. Initial combination therapy or maintenance of combination therapy should be individualized and left to the discretion of the health care provider.
This tablet should generally be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal (GI) side efects due to metformin.
The starting dose of this tablet should be based on the patient’s current regimen. This tablet should be given twice daily with meals.
The recommended starting dose in patients not currently treated with metformin is 50 mg sitagliptin/500 mg metformin hydrochloride twice daily, with gradual dose escalation recommended to reduce gastrointestinal side efects associated with metformin.
The starting dose in patients already treated with metformin should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and the dose of metformin already being taken. For patients taking metformin 850 mg twice daily, the recommended starting dose of this tablet is 50 mg sitagliptin/1000 mg metformin hydrochloride twice daily.
No studies have been performed specifcally examining the safety and efcacy of Sitagliptin Phosphate Monohydrate INN/Metformin Hydrochloride BP in patients previously treated with other oral antihyperglycemic agents and switched to Sitagliptin Phosphate Monohydrate INN/Metformin Hydrochloride BP. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.
Dose of extended-release tablet: Administer once daily with a meal preferably in the evening. Gradually escalate the dose to reduce the gastrointestinal side effects due to Metformin. May adjust the dosing based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of 100 mg Sitagliptin and 2000 mg Metformin extended-release. Maintain the same total daily dose of Sitagliptin and Metformin when changing between film-coated tablet and extended-release tablet, without exceeding the maximum recommended daily dose of 2000 mg Metformin extended-release.
Patients using two extended-release tablets (such as two 50/500 or two 50/1000 tablets) should take the two tablets together once daily. The 100 mg Sitagliptin/1000 mg Metformin HCI extended-release tablet should be taken as a single tablet once daily.
Patients treated with an insulin secretagogue or insulin: Co-administration of the combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.
",,"Cationic Drugs: Cationic drugs eliminated by renal tubular secretion: Use with caution.
Phenprocoumon: Metformin may decrease the anticoagulant effect of phenprocoumon. Therefore, close monitoring of the INR is recommended.
Levothyroxine: Levothyroxine can reduce the hypoglycemic effect of metformin. Monitoring of blood glucose levels is recommended, especially when thyroid hormone therapy is initiated or stopped, and the dosage of metformin must be adjusted if necessary.
","This tablet is contraindicated in patients with:
+
+- Renal disease or renal dysfunction, e.g., as suggested by serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females] or abnormal creatinine clearance which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia
+- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
+- History of a serious hypersensitivity reaction to this tablet or sitagliptin, such as anaphylaxis or angioedema.
+
+This tablet should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function.
","The most common adverse reactions reported in ≥5% of patients simultaneously started on sitagliptin and metformin and more commonly than in patients treated with placebo were diarrhea, upper respiratory tract infection, and headache.
Adverse reactions reported in ≥5% of patients treated with sitagliptin in combination with sulfonylurea and metformin and more commonly than in patients treated with placebo in combination with sulfonylurea and metformin were hypoglycemia and headache.
Hypoglycemia was the only adverse reaction reported in ≥5% of patients treated with sitagliptin in combination with insulin and metformin and more commonly than in patients treated with placebo in combination with insulin and metformin.
Nasopharyngitis was the only adverse reaction reported in ≥5% of patients treated with sitagliptin monotherapy and more commonly than in patients given placebo.
The most common (>5%) adverse reactions due to initiation of metformin therapy are diarrhea, nausea/vomiting, fatulence, abdominal discomfort, indigestion, asthenia, and headache.
","Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women with Sitagliptin Phosphate Monohydrate INN/Metformin Hydrochloride BP or its individual components; therefore, the safety of Sitagliptin Phosphate Monohydrate INN/Metformin Hydrochloride BP in pregnant women is not known. This tablet should be used during pregnancy only if clearly needed.
It is not known whether sitagliptin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this tablet is administered to a nursing woman.
","Lactic Acidosis-
+
+- Lactic acidosis can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic insufciency, renal impairment, and acute congestive heart failure.
+- Symptoms include malaise, myalgias, respiratory distress, increasing somnolence, and nonspecifc abdominal distress. Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate.
+- If acidosis is suspected, discontinue this tablet and hospitalize the patient immediately.
+- Regular monitoring of thyroid-stimulating hormone (TSH) levels is recommended in patients with hypothyroidism.
+- Long-term treatment with metformin has been associated with a decrease in vitamin B12 serum levels which may cause peripheral neuropathy. Monitoring of the vitamin B12 level is recommended.
+
+Others-
+
+- Do not use this tablet in patients with hepatic disease.
+- There have been postmarketing reports of acute renal failure, sometimes requiring dialysis. Before initiating this tablet and at least annually thereafter, assess renal function and verify as normal.
+- There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue this tablet.
+- Measure hematologic parameters annually.
+- Warn patients against excessive alcohol intake.
+- May need to discontinue this tablet and temporarily use insulin during periods of stress and decreased intake of fluids and food as may occur with fever, trauma, infection or surgery.
+- Promptly evaluate patients previously controlled on this tablet who develop laboratory abnormalities or clinical illness for evidence of ketoacidosis or lactic acidosis.
+- When used with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia.
+- There have been postmarketing reports of serious allergic and hypersensitivity reactions in patients treated with sitagliptin (one of the components of this tablet ), such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. In such cases, promptly stop this tablet, assess for other potential causes, and institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes.
+- There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Sitagliptin Phosphate Monohydrate INN/Metformin Hydrochloride BP or any other anti-diabetic drug.
+
",,"Sitagliptin: In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy as indicated by the patient's clinical status. Sitagliptin is modestly dialyzable. Prolonged hemodialysis may be considered if clinically appropriate. It is not known if sitagliptin is dialyzable by peritoneal dialysis.
Metformin hydrochloride: Overdose of metformin hydrochloride has occurred, including ingestion of amounts greater than 50 grams. Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected. Pancreatitis may occur in the context of a metformin overdose.
",,,"Store below 25°C in a dry place away from light. Keep the medicines in a safe place, out of the reach of children. Do not use later than the date of expiry. To be dispensed only on the prescription of a registered physician.
",11
+990,Sitagliptin,sitagliptin-990,https://medex.com.bd/attachments/adrZ3P6nVL4fmXb9px5d6ovSoUFlyP/sitagliptin-prescribing-information,Dipeptidyl Peptidase-4 (DPP-4) inhibitor,Type 2 DM,"Monotherapy and Combination Therapy: Sitagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Important Limitations of Use: Sitagliptin should not be used in patients with type 1 diabetes ... Read more
Monotherapy and Combination Therapy: Sitagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Important Limitations of Use: Sitagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. Sitagliptin has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Sitagliptin.
","Dipeptidyl Peptidase-4 (DPP-4) inhibitor
","Sitagliptin is a DPP-4 inhibitor, which is believed to exert its actions in patients with type 2 diabetes by slowing the inactivation of incretin hormones. Concentrations of the active intact hormones are increased by Sitagliptin, thereby increasing and prolonging the action of these hormones. Incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the intestine throughout the day, and levels are increased in response to a meal. These hormones are rapidly inactivated by the enzyme, DPP-4. The incretins are part of an endogenous system involved in the physiologic regulation of glucose homeostasis. When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells by intracellular signaling pathways involving cyclic AMP. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, leading to reduced hepatic glucose production. By increasing and prolonging active incretin levels, Sitagliptin increases insulin release and decreases glucagon levels in the circulation in a glucose-dependent manner. Sitagliptin demonstrates selectivity for DPP-4 and does not inhibit DPP-8 or DPP-9 activity in vitro at concentrations approximating those from therapeutic doses.
","The recommended dose of sitagliptin is 50 mg twice a day and 100 mg once daily. Sitagliptin can be taken with or without food.
",,"Effects of sitagliptin on other Drugs: Sitagliptin did not meaningfully alter the pharmacokinetics of metformin, glyburide, simvastatin, rosiglitazone, warfarin, or oral contraceptive.
Digoxin: Sitagliptin slightly increases the mean of Digoxin concentration. However, no dose adjustment of either drug is required.
","History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema.
","The most common adverse reactions include headache, upper respiratory tract infection and nasopharyngitis. Hypoglycemia may occur in patients treated with the combination to Sitagliptin and sulfonylurea and add on to insulin.
","Pregnancy Category B. Reproduction studies have been performed in rats and rabbits. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Sitagliptin is secreted in the milk of lactating rats at milk to plasma ratio of 4:1. It is not known whether sitagliptin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sitagliptin is administered to a nursing woman.
","If pancreatitis is suspected, sitagliptin should promptly be discontinued and appropriate management should be initiated.
Use in Patients with Renal Insufficiency: Dosage adjustment is recommended in patients with moderate or severe renal insufficiency and in patients with ESRD requiring hemodialysis or peritoneal dialysis.
Use with medications known to cause Hypoglycemia: When sitagliptin is used in combination therapy dosage adjustment of sulfonylurea or insulin may be required to reduce the risk of hypoglycemia.
Hypersensitivity Reactions: There have been post-marketing reports of serious hypersensitivity reactions in patients treated with sitagliptin. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. If a hypersensitivity reaction is suspected, discontinue sitagliptin, assess for other potential causes for the event, and institute alternative treatment for diabetes.
","Pediatric Use: Safety and effectiveness of sitagliptin in pediatric patients under 18 years of age have not been established.
Geriatric Use: This drug is known to be substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in the elderly, and it may be useful to assess renal function in these patients prior to initiating dosing and periodically thereafter.
For patients with mild renal insufciency: (CrCl <50 ml/min or serum creatinine levels of <1.7 mg/DL in men and <1.5 mg/DL in women), no dosage adjustment for sitagliptin is required.
For patients with moderate renal insufciency: (CrCl <30 to <50 mL/min, or serum creatinine levels of >1.7 to <3.0 mg/dL in men and >1.5 to <2.5 mg/dL in women), the dose of sitagliptin is 50 mg once daily.
For patients with severe renal insufficiency: (CrCl <30 mL/min or serum creatinine levels of >3.0 mg/dL in men and 2.5 mg/dL in women) or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of sitagliptin is 25 mg once daily. Sitagliptin may be administered without regard to the limiting of hemodialysis.
","During controlled clinical trials in healthy subjects, single doses of up to 800 mg Sitagliptin were administered. Maximal mean increases in QTc of 8.0 msec were observed in one study at a dose of 800 mg Sitagliptin, a mean effect that is not considered clinically important. There is no experience with doses above 800 mg in clinical studies. In Phase I multiple-dose studies, there were no dose-related clinical adverse reactions observed with Sitagliptin with doses of up to 600 mg per day for periods of up to 10 days and 400 mg per day for up to 28 days.
In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy as dictated by the patient's clinical status. Sitagliptin is modestly dialyzable. In clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour hemodialysis session. Prolonged hemodialysis may be considered if clinically appropriate. It is not known if sitagliptin is dialyzable by peritoneal dialysis.
",,,"Store below 25°C in a dry place away from light. Keep the medicines in a safe place, out of the reach of children. Do not use later than the date of expiry. To be dispensed only on the prescription of a registered physician
",12
+989,Simvastatin,simvastatin-989,https://medex.com.bd/attachments/WTI7tXBKzl8QXkSIubNZmteIhfUxHN/simvastatin-prescribing-information,Other Anti-anginal & Anti-ischaemic drugs,Stroke,"Primary hypercholesterolemia (type IIa and IIb) in patients who have not responded adequately to diet and other appropriate measures. Coronary heart disease and elevated plasma cholesterol level.
","Other Anti-anginal & Anti-ischaemic drugs, Statins
","Simvastatin is a preparation of Simvastatin which acts as a Cholesterol lowering agent. The main mechanism of reduction of low density lipoprotein (LDL) cholesterol is that following inhibition of HMG-CoA reductase activity, the LDL receptor density on the liver cells is increased and this leads to an increased removal of LDL cholesterol from the plasma and increased catabolism of LDL cholesterol. In addition, there is a reduction in the very low- density lipoprotein (VLDL) cholesterol and reduced formation of LDL from VLDL. Simvastatin is extensively metabolised in the liver; which is also the main site of action of the drug.
","The patient should be placed on a standard cholesterol lowering diet before receiving Simvastatin and should continue on this during treatment with Simvastatin. The usual starting dose is 10 mg/day given as a single dose in the evening. Adjustment of dosage, if required, should be made at intervals of not less than four weeks, to a maximum of 40 mg daily given as a single dose in the evening. If LDL-cholesterol levels fall below 2 mmol/L or total plasma cholesterol levels fall below 3.5 mmol/L consideration should be given to reducing the dose of Simvastatin. In hypercholesterolemia, the recommended starting dose is 5-10 mg once a day in the evening and the recommended dosing range is 5-40 mg per day as a single dose in the evening. In patients with coronary heart disease and hypercholesterolemia, the starting dose should be 20 mg once a day in the evening. Because Simvastatin does not undergo significant renal excretion, modification of dosage should not be necessary in patients with renal insufficiency. Safety and effectiveness in children and adolescents have not been established.
",,"Digoxin: Concomitant administration of Simvastatin and Digoxin in normal volunteers resulted in a slight elevation (less than 0.3 µgm/ml) in drug concentrations in plasma compared to concomitant administration of placebo and Digoxin.
Coumarin derivatives: Slightly enhance the anticoagulant effect of Warfarin (mean changes in p rothrombin time less than two seconds) in normal volunteers maintained in a state of low therapeutic anticoagulation.
Others: In clinical studies, Simvastatin was used concomitantly with ACE inhibitors, beta-blockers, calcium channel blockers, diuretics and NSAIDs without evidence of clinically significant adverse interactions.
","Simvastatin should not be used in-
+
+- Active liver disease
+- Pregnant and breast feeding mother
+- Women of child bearing age unless they have been adequately protected by contraception
+- Hypersensitivity to any component of the preparation
+- Patients with the homozygous familial hypercholesterolemia who have a complete absence of LDL receptors
+
","Simvastatin is generally well tolerated. Headache, fatigue, insomnia, gastrointestinal effects like nausea, constipation or diarrhoea, flatulence, dyspepsia, abdominal cramps and muscular effects like myalgia, myositis and myopathy have been reported. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been associated with Simvastatin therapy. Hepatitis, pancreatitis, rash, Angio-oedema have also been reported. No potentially life threatening effects have been reported.
","Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
","
+- If there is a history of liver disease
+- Who take high alcohol
+- Liver function test should be done before and during treatment
+- If serum transaminase rises three times the upper limit of normal, treatment should be discontinued
+- Avoid pregnancy during and for one month after treatment
+
",,"There are no data available on overdose. No antidote is available. General measures should be adopted and liver function should be monitored.
",,,"Store in a cool, dry place, Away from light keep out of reach of children.
",11
+988,Simethicone,simethicone-988,,Anti-dyspeptic/Carminatives,Upper Gl bloating,"Flatulence, abdominal distention, fullness, gas and windy colic: Simethicone is an excellent and effective antiflatulent. It is used for relief of the painful symptoms of excess gas in the digestive tract. Such gas is frequently caused by excessive swallowing of air or by eating foods ... Read more
Flatulence, abdominal distention, fullness, gas and windy colic: Simethicone is an excellent and effective antiflatulent. It is used for relief of the painful symptoms of excess gas in the digestive tract. Such gas is frequently caused by excessive swallowing of air or by eating foods that disagree. Simethicone drop is especially used in infants, acts in the stomach and intestines. Thus Simethicone enables freeing and eliminating the gas more easily by belching or passing flatus.
Large bowel preparation: Addition of Simethicone to a polyethylene glycol bowel preparation produces symptomatic improvement prior to investigation in the management of accidental ingestion of foaming detergents.
Treatment of poisoning: Simethicone has an anecdotal use as an antifoaming agent in the management of accidental ingestion of foaming detergents.
","Anti-dyspeptic/Carminatives
","Simethicone is used as an antiflatulent to relieve symptoms commonly referred to gas including upper GI bloating, pressure, fullness or stuffed feeling. The clinical use of Simeticone is based on its antifoaming properties. Its antifoaming action relieves flatulence by dispersing and preventing the formation of mucous surrounded gas pockets in the GI tract.
Simeticone acts in the stomach and intestines to change the surface tension of gas bubbles, enabling them to coalesce; thus gas is freed and eliminated more easily by belching or passing flatus. Simeticone aids in the elimination of gas from the GI tract and can be used to reduce postoperative gas pains. Simeticone can also be used prior to gastroscopy to enhance visualization and prior to radiography of the intestine to reduce gas shadows.
","Take after meals and at bedtime. Can be given with infant's feeds. Shake the bottle well before each use.
Children less than 2 years of age: 20 mg (0.3 ml Simethicone Paediatric Drops) 4 times daily up to 240 mg/day (3.6 ml Simethicone Paediatric Drops).
Children 2-12 years of age: 40 mg (0.6 ml Simethicone Paediatric Drops) 4 times daily.
Adults:
+
+- 40-125 mg (0.6 ml-1.9 ml Simethicone Paediatric Drops) 4 times daily, up to 500 mg/day (7.5 ml Simethicone Paediatric Drops) or
+- 1-3 Simethicone chewable tablets; 4 times daily, up to 500 mg/day (12 Simethicone chewable tablets).
+
",,"There is no evidence that Simethicone modifies the effect of other drugs. The defoaming effect of Simethicone is reduced by antacids such as Aluminium Hydroxide and Magnesium Carbonate, which absorb the Silicone.
",,"Simethicone is physiologically inert and no adverse effect has been noted after oral ingestion.
","Pregnant women: No data are available to suggest any harmful effects.
Lactating mother: Excretion of simethicone in breast milk has not been established, and would be most unlikely.
","Do not exceed 12 doses per day except under the advice and supervision of a physician.
",,,,,"Should be stored in cool and dry place, protected from light. Keep the medicine out of the reach of children.
",9
+986,Silver Sulfadiazine,silver-sulfadiazine-986,https://medex.com.bd/attachments/UoGOKGNBjoIUMfPV7IAGGd5lbm36vE/silver-sulfadiazine-prescribing-information,Topical Antibiotic preparations,Wounds,"Silver Sulfadiazine cream is indicated in-
+
+- The topical prophylaxis against bacterial colonization and infection in burn wounds.
+- The topical antibacterial management of certain contaminated or infection-prone wounds, other than burns.
+
","Topical Antibiotic preparations
","The mechanism of Silver Sulfadiazine's antibacterial action has not been fully elucidated. After exposure to the drug, structural changes in the bacterial cell membrane occur, including distortion and enlargement of the cell and a weakening of the cell wall membrane. This is accompanied by reduced viability in sensitive strains. The silver sulfadiazine molecule dissociates and the silver moiety is bound to the bacterial cells. It is believed that, after penetrating the cell wall, the silver moiety is attached to deoxyribonucleic acid (DNA) and prevents bacterial cell proliferation. There is approximately 100 times more DNA in mammalian cells than in bacterial cells. It is thought that the ratio of silver sulfadiazine to bacterial DNA is sufficiently high to prevent bacterial division but the corresponding ratio to epithelial DNA is low enough not to block epithelial cell regeneration. The sulfadiazine moiety also provides a bacteriostatic action against sensitive organisms. In adults, up to 10% of the sulfadiazine may be absorbed and 60 to 85% of the absorbed amount is excreted in the urine. In children with 13% body surface area burns, the urinary sulfadiazine concentration was 31.8 mg/L.
","The burn wounds are cleansed, and Silver Sulfadiazine is applied over the burn wound. The burn areas should be covered with Silver Sulfadiazine at all times. The cream should be applied once to twice daily to a thickness of approximately 1/16 inches or 1.5 mm. Whenever necessary; the cream should be reapplied to any areas from which it has been removed by patient activity. If individual patient requirements make dressings necessary, they may be used. Reapplication should be ensured immediately after hydrotherapy. Treatment with Silver Sulfadiazine should be continued until satisfactory healing is occurred, or until the burn site is ready for grafting. The drug should not be withdrawn from the therapeutic regimen while there remains the possibility of infection except if a significant adverse reaction occurs.
",,"Enzymatic debriding agents: Silver sulfadiazine may inactivate enzymatic debriding agents, thus the concomitant use of these compounds may be inappropriate.
Oral hypoglycemic agents and phenytoin: In patients with large area burns where serum sulfadiazine levels may approach therapeutic levels, the action of oral hypoglycemic agents and phenytoin may be potentiated and it is recommended that blood levels be monitored.
Cimetidine: In-patients with large area burns, it has been reported that co-administration of Cimetidine may increase the incidence of leukopenia.
","It is contraindicated in-patients who are hypersensitive to it or any of the other ingredients in the preparation. It should not be used on pregnant women approaching or at term, on premature infants, or on newborn infants during the first 2 months of life
","Several cases of transient leukopenia have been reported in-patients receiving Silver Sulfadiazine therapy. Other infrequently occurring events include skin necrosis, erythema multiform, skin discoloration, burning sensation, rashes, and interstitial nephritis.
","Pregnancy Category B. This drug should be used during pregnancy only if clearly justified, especially in pregnant women approaching or at term. It is not known whether Silver Sulfadiazine is excreted in human milk. A decision should be made, whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use Safety and effectiveness in pediatric patients have not been established.
","General: If hepatic and renal functions become impaired and elimination of drug decreases, accumulation may occur and discontinuation of this should be weighed against the therapeutic benefit being achieved. In considering the use of topical proteolytic enzymes in conjunction with it, the possibility should be noted that silver might inactivate such enzymes.
Laboratory Tests: In the treatment of burn wounds involving extensive areas of the body, the serum sulfa concentrations may approach adult therapeutic levels (8 mg% to 12 mg%). Therefore, in these patients it would be advisable to monitor serum sulfa concentrations. Renal function should be carefully monitored and the urine should be checked for sulfa crystals.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+985,Silodosin,silodosin-985,https://medex.com.bd/attachments/QifSPH0F9deKYpgc9BhYJbVsu3qHTj/silodosin-prescribing-information,BPH/ Urinary retention/ Urinary incontinence,Benign prostatic hyperplasia (BPH),"Silodosin, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Silodosin is not indicated for the treatment of hypertension.
+
+- Highly effective for the treatment of Benign Prostatic Hyperplasia.
... Read more
Silodosin, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Silodosin is not indicated for the treatment of hypertension.
+
+- Highly effective for the treatment of Benign Prostatic Hyperplasia.
+- Highest uroselectivity to alpha-1 adrenergic receptor.
+- Effective treatment option for BPH who are not responding to Tamsulosin.
+- Dose not cause Orthostatic hypotension.
+- Convenient once-daily dosing.
+
","BPH/ Urinary retention/ Urinary incontinence
","Silodosin is a selective antagonist of post-synaptic alpha-1 adrenoreceptors, which are located in the human prostate, bladder base, bladder neck, prostatic capsule and prostatic urethra. Blockade of these alpha-1 adrenoreceptors can cause smooth muscle in these tissues to relax, resulting in an improvement in urine flow and a reduction in BPH symptoms.
","The recommended dose is Silodosin 8 mg orally once daily with a meal. 4 mg capsules taken orally once daily with a meal for those with moderate renal impairment (CrCl 30-50 mL/min).
",,"Strong P-glycoprotein inhibitors (e.g., cyclosporine): Co-administration may increase plasma Silodosin concentration. Concomitant use of PDE5 inhibitors with alpha-blockers including Silodosin can potentially cause symptomatic hypotension.
","Patients with severe renal & hepatic impairment, concomitant administration with strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir) and patients with a history of hypersensitivity to Silodosin.
","Most common adverse reactions are retrograde ejaculation, dizziness, diarrhea, orthostatic hypotension, headache, nasopharyngitis and nasal congestion.
","Pregnancy Category B. Silodosin is not indicated for use in women. An embryo/fetal study in rabbits showed decreased maternal body weight at 200 mg/kg/day (approximately 13-25 times the maximum recommended human exposure or MRHE of Silodosin via AUC). No statistically significant teratogenicity was observed at this dose. Silodosin was not teratogenic when administered to pregnant rats during organogenesis at 1000 mg/kg/day (estimated to be approximately 20 times the MRHE). No maternal or fetal effects were observed at this dose. Rats and rabbits do not produce glucuronidated Silodosin, which is present in human serum at approximately 4 times the level of circulating Silodosin and which has similar pharmacological activity to Silodosin. No effects on physical or behavioral development of offspring were observed when rats were treated during pregnancy and lactation at up to 300 mg/kg/day.
","Postural hypotension with or without symptoms (e.g. dizziness) may develop when beginning Silodosin treatment. Silodosin should not be used in combination with other alpha-blocker. Inform patients planning cataract surgery to notify their ophthalmologist that they are taking Silodosin because of the possibility of Intraoperative Floppy Iris Syndrome (IFIS)
","Pediatric patients: Silodosin is not indicated for use in pediatric patients.
Geriatric use: In double-blind, placebo-controlled, 12-week clinical studies of Silodosin, 259 (55.6%) were under 65 years of age, 207 (44.4%) patients were 65 years of age and over, while 60 (12.9%) patients were 75 years of age and over. Orthostatic hypotension was reported in 2.3% of Silodosin patients < 65 years of age (1.2% for placebo), 2.9% of Silodosin patients > 65 years of age (1.9% for placebo), and 5.0% of patients > 75 years of age (0% for placebo). There were otherwise no significant differences in safety or effectiveness between older and younger patients.
Renal impairment: Silodosin is contra-indicated in patients with severe renal impairment (CCr <30 mL/min). In patients with moderate renal impairment (CCr 30-50 mL/min), the dose should be reduced to Silodosin 4 mg once daily taken with a meal. No dosage adjustment is needed in patients with mild renal impairment (CCr 50-80 mL/min).
Hepatic impairment: Silodosin has not been studied in patients with severe hepatic impairment (Child-Pugh score >10) and is therefore contra-indicated in these patients. No dosage adjustment is needed in patients with mild or moderate hepatic impairment.
","Silodosin was evaluated at doses of up to 48 mg/day in healthy male subjects. The dose-limiting adverse event was postural hypotension. Should overdose of Silodosin lead to hypotension, support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by maintaining the patient in the supine position. If this measure is inadequate, administration of intravenous fluid should be considered. If necessary, vasopressors could be used, and renal function should be monitored and supported as needed. Dialysis is unlikely to be of significant benefit since Silodosin is highly (97%) protein bound.
",,,"Store at below 30°C in a dry place protected from light. Keep out of reach of Children.
",12
+1596,Somatostatin,somatostatin-1596,https://medex.com.bd/attachments/Jp9742ZsSa9K2yH0iNzyuGnTbTzlXI/somatostatin-prescribing-information,Growth hormone antagonist,Haemorrhage,"Somatostatin is indicated for:
+
+- Severe acute haemorrhage from oesophageal varices.
+- Severe acute haemorrhage from gastric or duodenal ulcers, or accompanying acute erosive or haemorrhagic gastritis.
+- Adjuvant treatment of pancreatic, biliary and intestinal fistulae.
... Read more
Somatostatin is indicated for:
+
+- Severe acute haemorrhage from oesophageal varices.
+- Severe acute haemorrhage from gastric or duodenal ulcers, or accompanying acute erosive or haemorrhagic gastritis.
+- Adjuvant treatment of pancreatic, biliary and intestinal fistulae.
+- Prophylaxis and treatment of postoperative complications following pancreatic surgery.
+
","Growth hormone antagonist
","Somatostatin is a synthetic cyclic 14 amino-acid peptide, which is identical in structure and action to natural somatostatin. By intravenous infusion in humans, somatostatin causes inhibition of growth hormone, thyroid stimulating hormone, insulin and glucagon secretion as well as inhibition of gastric acid secretion. It also affects the absorption, motility, splanchnic blood flow and trophic functions of the gastro-intestinal tract. Physiologically, somatostatin is found mainly in the gastro-intestinal tract and in the hypothalamus.
Somatostatin inhibits the release of gastrin, gastric acid, and pepsin which supports its indication in the treatment of upper gastro-intestinal haemorrhage. Furthermore, somatostatin is capable of reducing remarkably splanchnic blood flow without causing significant variations in the systemic arterial pressure, which proves to be valuable for the management of oesophageal variceal haemorrhage. Somatostatin reduces both pancreatic endocrine and exocrine secretion which makes it effective in the prophylaxis and treatment of postoperative complications of pancreatic surgery. The positive effect of somatostatin in the management of diabetic ketoacidosis can be ascribed to its suppression activity of glucagon secretion.
","Somatostatin is given intravenously, by slow bolus injection (3 to 5 minutes) of 250 µg or by continuous infusion at a rate of 250 µg/hour (equivalent of approximately 3.5 µg/kg body weight/hour). The lyophilised powder should be reconstituted with the physiological sodium chloride solution immediately prior to use. For continuous infusion one 3 mg of Somatostatin ampoule should be used to prepare a 12 hours infusion. The solution may be either saline or 5 % dextrose and should be adjusted to guarantee an outflow of 250 µg somatostatin/hour. The use of a perfusion syringe is recommended.
Treatment of severe acute bleeding from the upper gastro-intestinal tract, including from oesophageal varices: It is recommended to start by a slow intravenous injection of 250 µg of Somatostatin as loading dose, then immediately followed by an intravenous infusion at a rate of 250 µg/h. In case of interruption of more than 3 to 5 minutes between two infusions, an additional slow intravenous injection of 250 µg is recommended to ensure a continuous treatment. Once the haemorrhage has stopped (usually in less than 12 to 24 hours), treatment should be continued for 48-72 hours in order to avoid rebleeding. Treatment up to 120 hours has been routinely performed in this indication.
Adjuvant treatment in pancreatic, biliary and intestinal fistulae: A continuous infusion of Somatostatin at a rate of 250 µg/h is recommended until closure of the fistulae (2-20 days). This infusion should be performed in addition to total parenteral nutrition. Once the fistula has been closed, treatment should be continued for 1 to 3 days and stopped progressively in order to avoid rebound effect. Prophylactic treatment of postoperative complications following pancreatic surgery: Somatostatin is administered at the beginning of the surgical intervention at a rate of 250 µg/h and treatment is continued for 5 days.
",,"Since somatostatin lengthens the time of hexobarbital-induced sleep and potentiates the action of pentetrazol, Somatostatin should not be administered concomitantly with these drugs or with drugs exerting the same effects.
","Somatostatin is contra-indicated:
+
+- During pregnancy and the immediate post-partum period (puerperium) as well as during lactation. There is no evidence of the drug’s safety in human pregnancy nor is there evidence from animal work that it is free from hazard.
+- In states of proven hypersensitivity to somatostatin.
+
","Nausea, vertigo, and flushing have been reported rarely. Nausea and vomiting have been reported when the infusion rate is greater than 50 µg/min.
","Avoid in pregnancy unless there is no safer alternative.
","Due to its inhibitory effect on the secretion of insulin and glucagon, the administration of Somatostatin can, at the onset of treatment, lead to a transient fall in blood glucose level. Caution is, therefore, called for in insulin-dependent diabetic patients in whom blood glucose should be measured every 3-4 hours. Simultaneous administration of insulin-requiring sugars should, if possible, be avoided. If necessary, insulin should be administered.
",,,,,"Storage condition and expiry date are indicated on the box. Solutions of Somatostatin in physiological sodium chloride are stable for 24 hours.
",10
+1007,Solifenacin Succinate,solifenacin-succinate-1007,https://medex.com.bd/attachments/oC7iWZxpSHWBC9AzhyE1ugCH8cHB2h/solifenacin-succinate-prescribing-information,Anticholinergics (antimuscarinics)/ Anti-spasmodics,Urinary frequency and urgency,"Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.
","Anticholinergics (antimuscarinics)/ Anti-spasmodics, BPH/ Urinary retention/ Urinary incontinence
","Solifenacin is a competitive muscarinic receptor antagonist. It has the highest affinity for M3, M1, and M2 muscarinic receptors. 80% of the muscarinic receptors in the bladder are M2, while 20% are M3. Solifenacin's antagonism of the M3 receptor prevents contraction of the detrusor muscle, while antagonism of the M2 receptor may prevent contraction of smooth muscle in the bladder.
","The recommended dose for adults and the elderly: Solifenacin Succinate 5 mg once daily. If needed, the dose may be increased to Solifenacin Succinate 10 mg once daily.
Use in children: Safety and effectiveness in children have not yet been established. Therefore, Solifenacin Succinate should not be used in children.
",,"Concomitant medication with other medicinal products with anticholinergic properties may result in more pronounced therapeutic effects and undesirable effects. An interval of approximately one week should be allowed after stopping treatment with Solifenacin Succinate before commencing other anticholinergic therapy. The therapeutic effect of Solifenacin may be reduced by concomitant administration of cholinergic receptor agonists. Solifenacin can reduce the effect of medicinal products that stimulate the motility of the gastrointestinal tract, such as Metoclopramide and Cisapride. In vitro studies have demonstrated that at therapeutic concentrations, Solifenacin does not inhibit CYP1A1/2, 2C9, 2C19, 2D6, or 3A4 derived from human liver microsomes. Therefore, Solifenacin is unlikely to alter the clearance of drugs metabolized by these CYP enzymes. Solifenacin is metabolized by CYP3A4. Simultaneous administration of Ketoconazole (200 mg/day), a potent CYP3A4 inhibitor, resulted in a two-fold increase of the AUC of Solifenacin, while Ketoconazole at a dose of 400 mg/day resulted in a three-fold increase of the AUC of Solifenacin. Therefore, the maximum dose of Solifenacin Succinate should be restricted to 5 mg when used simultaneously with Ketoconazole or therapeutic doses of other potent CYP3A4 inhibitors (e.g. Ritonavir, Nelfinavir, Itraconazole).
Simultaneous treatment of Solifenacin and a potent CYP3A4 inhibitor is contra-indicated in patients with severe renal impairment or moderate hepatic impairment. The effects of enzyme induction on the pharmacokinetics of Solifenacin and its metabolites have not been studied as well as the effect of higher affinity CYP3A4 substrates on Solifenacin exposure. Since Solifenacin is metabolised by CYP3A4, pharmacokinetic interactions are possible with other CYP3A4 substrates with higher affinity (e.g. Verapamil, Diltiazem) and CYP3A4 inducers (e.g. Rifampicin, Phenytoin, Carbamazepine).
Effect of Solifenacin on the pharmacokinetics of other medicinal products:
+
+- Oral Contraceptives: Intake of Solifenacin showed no pharmacokinetic interaction on combined oral contraceptives (Ethinylestradiol/Levonorgestrel).
+- Warfarin: Intake of Solifenacin did not alter the pharmacokinetics of R-warfarin or S-warfarin or their effect on prothrombin time.
+- Digoxin: Intake of Solifenacin showed no effect on the pharmacokinetics of digoxin.
+- Effects on ability to drive and use machines: Since Solifenacin, like other anticholinergics may cause blurred vision and, uncommonly, somnolence and fatigue, the ability to drive and use machines may be negatively affected.
+
","Solifenacin is contraindicated in patients with hypersensitivity to solifenacin or to any of the excipients. It is also contraindicated in myasthenia gravis, urinary retention, uncontrolled narrow angle glaucoma, severe gastro-intestinal condition (including toxic megacolon), patients undergoing haemodialysis, patients with severe hepatic impairment, patients with severe renal impairment or moderate hepatic impairment and on treatment with a strong CYP3A4 inhibitor, e.g. ketoconazole.
","Due to the pharmacological effect of Solifenacin, it may cause anticholinergic undesirable effects of (in general) mild or moderate severity. The frequency of anticholinergic undesirable effects is dose related. The most commonly reported adverse reactionwith Solifenacin is dry mouth. It occurred in 11% of patients treated with 5 mg once daily, in 22% of patients treated with 10 mg once daily and in 4% of placebo-treated patients. The severity of dry mouth was generally mild and only occasionally led to discontinuation of treatment. In general,medicinal product compliance was very high (approximately 99%) and approximately 90% of the patients treated with Solifenacin completed the full study period of 12 weeks treatment.
+
+- Gastrointestinal disorders: very common- dry mouth, common-constipation, nausea, dyspepsia, abdominal pain, uncommon- gastroesophageal reflux diseases, dry throat, rare- colonic obstruction, faecal impaction, very rare- vomiting.
+- Infections and infestations: uncommonurinary tract infection, cystitis.
+- nervous system disorders: uncommon- somnolence, dysgeusia, very rare-dizziness, headache.
+- psychiatric disorders: very rare- hallucinations.
+- eye disorders: common- blurred vision, uncommon- dry eyes.
+- General disorders and administration site conditions: uncommon- fatigue, peripheral oedema.
+- Respiratory, thoracic and mediastinal disorders: uncommon nasal dryness.
+- skin and subcutaneous tissue disorders: uncommon- dry skin, very rare- pruritus, rash, urticaria.
+- renal and urinary disorders: uncommon- difficulty in micturition, rare- urinary retention.
+
","No clinical data are available from women who became pregnant while taking Solifenacin. Animal studies do not indicate direct harmful effects on fertility, embryonal / foetal development or parturition. The potential risk for humans is unknown. Caution should be exercised when prescribing to pregnant women. No data on the excretion of Solifenacin in human milk are available. In mice, Solifenacin and/or its metabolites was excreted in milk, and caused a dose dependent failure to thrive in neonatal mice. The use of Solifenacin should therefore be avoided during breast-feeding.
","Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Solifenacin Succinate. If urinary tract infection is present, an appropriate antibacterial therapy should be started. Solifenacin Succinate should be used with caution in patients with: clinically significant bladder outflow obstruction at risk of urinary retention, gastrointestinal obstructive disorders, risk of decreased gastrointestinal motility, severe renal impairment (creatinine clearance 30 ml/min), moderate hepatic impairment (Child-Pugh score of 7 to 9) and doses should not exceed 5 mg for these patients. Caution should be taken in concomitant use of a potent CYP3A4 inhibitor e.g. Ketoconazole, hiatus hernia/ gastroesophageal reflux and/or who are concurrently taking medicinal products (such as Bisphosphonates) that can cause or exacerbate oesophagitis, autonomic neuropathy. Safety and efficacy have not yet been established in patients with a neurogenic cause for detrusor overactivity. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. The maximum effect of Solifenacin Succinate can be determined after 4 weeks at the earliest.
","Patients with renal impairment: No dose adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance >30 ml/min). Patients with severe renal impairment (creatinine clearance <30 ml/min) should be treated with caution and receive no more than 5 mg once daily.
Patients with hepatic impairment: No dose adjustment is necessary for patients with mild hepatic impairment. Patients with moderate hepatic impairment (Child-Pugh score of 7 to 9) should be treated with caution and receive no more than 5 mg once daily.
Potent inhibitors of cytochrome P450 3A4: The maximum dose of Solifenacin Succinate should be limited to 5 mg when treated simultaneously with Ketoconazole or therapeutic doses of other potent CYP3A4 inhibitors e.g. Ritonavir, Nelfinavir, Itraconazole. Solifenacin Succinate tablet should be taken orally and should be swallowed whole with liquids. It can be taken with or without food.
","Over dosage with Solifenacin Succinate can potentially result in severe anticholinergic effects. The highest dose of Solifenacin Succinate accidentally given to a single patient was 280 mg in a 5 hour period, resulting in mental status changes not requiring hospitalization. In the event of overdose with Solifenacin Succinate, the patient should be treated with activated charcoal. Gastric lavage is useful if performed within 1 hour, but vomiting should not be induced. As for other anticholinergics, symptoms can be treated as follows:
+
+- Severe central anticholinergic effects such as hallucinations or pronounced excitation: treat with physostigmine or carbachol.
+- Convulsions or pronounced excitation: treat with benzodiazepines.
+- Respiratory insufficiency: treat with artificial respiration.
+- Tachycardia: treat with beta-blockers.
+- Urinary retention: treat with catheterisation.
+- Mydriasis: treat with pilocarpine eye drops and/or place patient in a dark room.
+
+As with other antimuscarinics, in case of overdosing, specific attention should be paid to patients with known risk for QT-prolongation (i.e. hypokalaemia, bradycardia and concurrent administration of medicinal products known to prolong QT interval) and relevant pre-existing cardiac diseases (i.e. myocardial ischaemia, arrhythmia, congestive heart failure).
",,,"Store in a cool and dry place, protected from light.
",12
+1006,Sofosbuvir + Velpatasvir,sofosbuvir-velpatasvir-1006,https://medex.com.bd/attachments/JQJDc4jIRAdUDHjUoNHxBCBUF0K6Br/sofosbuvir-velpatasvir-prescribing-information,Hepatic viral infections (Hepatitis C),Chronic hepatitis C,"Sofosbuvir and Velpatasvir combination is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection-
+
+- Without cirrhosis or with compensated cirrhosis
+- With decompensated cirrhosis for use in combination with ribavirin
+
","Hepatic viral infections (Hepatitis C)
","It is a fixed-dose combination tablet containing sofosbuvir and velpatasvir for oral administration. Sofosbuvir is a nucleotide analog HCV NS5B polymerase inhibitor and velpatasvir is an NS5A inhibitor.
","The recommended dosage is one tablet (400 mg of Sofosbuvir and 100 mg of Velpatasvir) taken orally once daily. Recommended treatment regimen:
+
+- Patients without cirrhosis and patients with compensated cirrhosis (Child-Pugh A): one tablet once daily for 12 weeks
+- Patients with decompensated cirrhosis (Child-Pugh B or C): one tablet once daily and Ribavirin for 12 weeks. The recommended dosage of Ribavirin is based on bodyweight (1000 mg/day for patients < 75 kg and 1200 mg/day for ≥ 75 kg, in two divided dose/day)
+
",,"Drugs may decrease the concentrations of sofosbuvir and/or velpatasvir: Antacids, H2-receptor antagonists, Proton-pump inhibitors etc.
Coadministration is not recommended with: topotecan, Carbamazepine, Phenytoin, Phenobarbital, Oxcarbazepine, Rifabutin, Rifampin, Rifapentine, efavirenz, Tipranavir, Ritonavir, Hypericum perforatum.
Coadministration of Sofosbuvir and Velpatasvir combination, with Rosuvastatin, Atorvastatin may significantly increase the concentration of Rosuvastatin, Atorvastatin.
","Sofosbuvir, Velpatasvir and Ribavirin combination regimen is contraindicated in patients for whom Ribavirin is contraindicated.
","The most common side effects of Sofosbuvir and Velpatasvir combination include headache and tiredness. Treatment may result in slowing of the heart rate along with other symptoms when taken with amiodarone (a medicine used to treat certain heart problems).
","No adequate human data are available to establish whether or not Sofosbuvir and Velpatasvir combination poses a risk to pregnancy outcomes. If Sofosbuvir and Velpatasvir combination administered with Ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partner is pregnant or going to be pregnant in next six months.
","Serious symptomatic bradycardia may occur in patients taking amiodarone, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Coadministration of amiodarone with Sofosbuvir and Velpatasvir combination is not recommended. In patients without alternative viable treatment options, cardiac monitoring is recommended.
","Renal impairment patient: No dosage recommendation can be given for patients with severe renal impairment (eGFR ≤30 mL/min/1.73 m2) or with ESRD, due to higher exposures of the predominant sofosbuvir metabolite.
","If overdose occurs the patient must be monitored for evidence of toxicity. Treatment of overdose includes monitoring of vital signs as well as observation of the clinical status of the patient.
",,,"Store in a cool and dry place (preferably below 30° C). Keep out of reach of children.
",12
+1005,Sofosbuvir,sofosbuvir-1005,https://medex.com.bd/attachments/TAb0mt6zqIKluau2cijbdleKUfM6lf/sofosbuvir-prescribing-information,Hepatic viral infections (Hepatitis C),Chronic hepatitis C,"Sofosbuvir is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.
Sofosbuvir efficacy has been established in subjects with HCV genotype 1, 2, ... Read more
Sofosbuvir is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.
Sofosbuvir efficacy has been established in subjects with HCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection.
The following points should be considered when initiating treatment with Sofosbuvir:
+
+- Monotherapy of Sofosbuvir is not recommended for treatment of CHC.
+- Treatment regimen and duration are dependent on both viral genotype and patient population.
+- Treatment response varies based on baseline host and viral factor.
+
","Hepatic viral infections (Hepatitis C)
","Sofosbuvir is nucleotide analog inhibitor, which specifically inhibits HCV NS5B (non-structural protein 5B) RNA-dependent RNA polymerase. Following intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), sofosbuvir incorporates into HCV RNA by the NS5B polymerase and acts as a chain terminator. More specifically, Sofosbuvir prevents HCV viral replication by binding to the two Mg2+ ions present in HCV NS5B polymerase's GDD active site motif and preventing further replication of HCV genetic material
","One 400 mg tablet taken once daily with or without food. Should be used in combination with Ribavirin or in combination with Pegylated Interferon and Ribavirin for the treatment of CHC.
Recommended combination therapy: (HCV Mono-infected and HCV/HIV-1 Co-infected)-
+
+- Genotype 1 or 4: Sofosbuvir + Peginterferon alfa + Ribavirin for 12 weeks
+- Genotype 2: Sofosbuvir + Ribavirin for 12 weeks
+- Genotype 3: Sofosbuvir + Ribavirin for 24 weeks
+
+Sofosbuvir in combination with Ribavirin for 24 weeks can be considered for CHC patients with genotype 1 infection who are Interferon ineligible
Should be used in combination with Ribavirin for treatment of CHC in patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation whichever occurs first
A dose recommendation cannot be made for patients with severe renal impairment or end stage renal disease
",,"Reduced therapeutic effect with drugs that are potent P-gp inducers in the intestine (eg rifampicin, St. John's wort, carbamazepine & phenytoin), modafinil, phenobarb/ oxcarbazepine, rifabutin/ rifapentine. P-gp &/or BCRP inhibitors. May result in serious symptomatic bradycardia when co-administered with amiodarone in combination with another direct acting antiviral.
","When Sofosbivur is used in combination with Ribavirin or Peginterferon alfa/ Ribavirin, the contraindications applicable to those agents are applicable to combination therapies. Sofosbuvir combination treatment with Ribavirin or Peginterferon alfa/Ribavirin is contraindicated in women who are pregnant or may become pregnant and men whose female partners are pregnant, because of the risks for birth defects and fetal death associated with Ribavirin.
","The most common adverse events (incidence greater than or equal to 20%, all grades) observed with Sofosbuvir in combination with Ribavirin were fatigue and headache. The most common adverse events observed with Sofosbuvir in combination with Peginterferon alfa and Ribavirin were fatigue, headache, nausea, insomnia, anemia, pruritus, asthenia, rash, decreased appetite, chills, influenza like illness, pyrexia, diarrhea, neutropenia, myalgia, irritability.
","Pregnancy Category B: Sofosbuvir There are no adequate and well-controlled studies with Sofosbuvir in pregnant women.
Nursing Mothers: It is not known whether Sofosbuvir and its metabolites are present in human breast milk.
","Bradycardia with amiodarone co-administration: Serious symptomatic bradycardia may occur in patients taking amiodarone and Sofosbuvir in combination with another direct acting antiviral (DAA), particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Co-administration of amiodarone with Sofosbuvir in combination with another DAA is not recommended. In patients without alternative, viable treatment options, cardiac monitoring is recommended.
","Pediatric Use: Safety and effectiveness of Sofosbuvir in children less than 18 years of age have not been established.
Geriatric Use: Sofosbuvir was administered to 90 subjects aged 65 and over. The response rates observed for subjects over 65 years of age were similar to that of younger subjects across treatment groups. No dose adjustment of Sofosbuvir is warranted in geriatric patients.
","The highest dose of Sofosbuvir is a single dose of Sofosbuvir 1200 mg. No specific antidote is available for overdose treatment. Treatment of overdose with Sofosbuvir consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
",,,"Keep out of the reach of children. Keep in a cool & dry place. Protect from light.
",12
+1004,Sodium Valproate,sodium-valproate-1004,https://medex.com.bd/attachments/oQ8UWNDEUJ8SUCM5Tbb5cp4b9sluvS/sodium-valproate-prescribing-information,Primary anti-epileptic drugs,Unipolar and bipolar depression,"Sodium Vaiproate oral is indicated for the treatment of all types of epilepsy, e.g.
+
+- Partial seizures
+- Absence seizures (petit mal)
+- Generalized tonic-clonic seizures (grand mal)
+- Myoclonic seizures
+- Atonic seizures
+- Mixed seizures that include absence attack
... Read more
Sodium Vaiproate oral is indicated for the treatment of all types of epilepsy, e.g.
+
+- Partial seizures
+- Absence seizures (petit mal)
+- Generalized tonic-clonic seizures (grand mal)
+- Myoclonic seizures
+- Atonic seizures
+- Mixed seizures that include absence attack
+- Prophylaxis of febrile convulsion
+- Prophylaxis of post-traumatic epilepsy.
+
+It is also indicated in the treatment of bipolar disorder & prophylaxis of migraine.
","Primary anti-epileptic drugs
","Sodium Valproate, the active ingredient of this preparation is endowed with anti-epileptic activity against a variety of seizures. The mechanism by which Sodium Valproate exerts its anti-epileptic effects has not been established. However, it has been suggested that its activity is related to increase brain levels of gamma-aminobutyric acid (GABA).
","Sodium Valproate tablets may be given once or twice daily. Sodium Valproate syrup should be given in divided doses.
Epilepsy-
+
+- Adults: Initially 600 mg daily given in 2 divided doses, preferably after food, increasing by 200 mg/day at 3-day intervals to a maximum of 2.5 g daily in divided doses until control of seizure is achieved. Usual maintenance dose is 1-2 g daily (20-30 mg/kg daily)
+- Children (up to 20 kg): Initially 20 mg/kg daily in divided doses, may be increased provided plasma concentrations monitored (above 40 mg/kg daily also monitor clinical chemistry and hematological parameters).
+- Children (over 20 kg): Initially 400 mg daily in divided doses increased until control (usually in the range of 20-30 mg/kg daily) Maximum 35 mg/kg daily.
+
+
Febrile convulsion: 20-30 mg/kg/day in 3 divided doses.
Bipolar disorder: Initially 20-30 mg/kg/day in 2-3 divided doses; adjust dosage in 3-5 days. Maintenance dosage is 1000-2000 mg/day.
Prophylaxis of migraine: 300 mg twice daily, although some may require 1000 mg daily.
",,"Sodium Vaiproate appears to act as a non specific inhibitor of drug metabolism. Drugs to which it interacts most significantly are Phenobarbital, Phenytoin, Warfarin, Aspirin etc.
","Sodium Valproate is contraindicated to patients who have known hypersensitivity to the drug and liver dysfunction. Use of Sodium Valproate is restricted during pregnancy and in women of childbearing potential.
","The most common side effects are anorexia, nausea and vomiting. However, these side effects are minimized with the use of enteric coated tablets. Effects on the CNS include sedation, ataxia and tremor. These symptoms occur infrequently and usually respond to a decrease in doses. Rash, alopecia and stimulation of appetite have been observed occasionally. Sodium Vaiproate has several effects on hepatic function of which elevation of liver enzymes in plasma is observed in up to 40% of patients and often occurs asymptomatically during the first few months of therapy. Rarely a fulminate hepatitis that may be fatal may develop. Children below 2 years of age with other medical conditions and those being treated with multiple antiepileptic agents are specially prone to suffer from hepatic injury, acute pancreatitis and hyperammonemia have also been frequently associated with the use of Sodium Valproate.
","Sodium Vaiproate crosses the placenta and in humans, exposure to valproate in the first trimester has been associated with neural tube defects such as anencephaly and spina bifida in newborn. Pregnant women treated with Sodium Vaiproate should be offered to estimate serum a-fetoprotein. Sodium Valproate is excreted in breast miik. However, breast-feeding by a mother taking Sodium Valproate probably causes no risk to the child.
","Liver functions should be monitored before therapy and during first 6 months especially in patients most at risk, No undue potential for bleeding before starting and before major surgery must be ensured, Care should be taken in renal impairment, pregnancy, breast-feeding and systemic lupus erythematosus. Sodium Valproate is partially eliminated in the urine as a ketone metabolite, which may lead to a false interpretation of the urine ketone test. Sudden withdrawal of therapy should be avoided. Sodium Valproate should not be used during pregnancy and in women of childbearing potential.
",,,,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",10
+1003,Sodium Thiosulfate,sodium-thiosulfate-1003,https://medex.com.bd/attachments/xT6afYEQOu9mg6TmRNOBmTayAJxKMh/sodium-thiosulfate-prescribing-information,Antidote preparations,Cyanide poisoning,"Sodium Thiosulfate is indicated for sequential use with sodium nitrite for treatment of acute cyanide poisoning that is judged to be life threatening. Use with caution if the diagnosis of cyanide poisoning is uncertain.
","Antidote preparations
","Sodium thiosulfate acts as an antidote in the treatment of cyanide poisoning. It acts as a sulphur-donating substrate for the enzyme rhodanese, thus speeding up the conversion of cyanide to thiocyanide, which is relatively non toxic. It is often used in combination with sodium nitrite but may be used alone in less severe poisoning.
","Adult: To be given after 300 mg of sodium nitrite has been admin over 5-20 min: 12.5 g of sodium thiosulfate (50 ml of a 25% solution or 25 ml of a 50% solution) given over 10 min. Methaemoglobin concentration should not exceed 30-40%. If symptoms of cyanide toxicity recur, the doses of nitrite and thiosulfate may be repeated after 30 min at half the initial doses.
Child: To be given after 4-10 mg/kg of sodium nitrite (max: 300 mg) has been admin: 400 mg/kg of sodium thiosulfate, as a 25 or 50% solution (max: 12.5 g). Methaemoglobin concentration should not exceed 30-40%. If symptoms of cyanide toxicity recur, the doses of nitrite and thiosulfate may be repeated after 30 min at half the initial doses.
",,"Formal drug interaction studies have not been conducted with Sodium Thiosulfate.
",,"Osmotic disturbances. Oral: catharsis (at high doses).
","Pregnancy Category C. There are no adequate and well controlled studies in pregnant women. Sodium Thiosulfate Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether sodium thiosulfate is excreted in human milk. Because Sodium Thiosulfate Injection may be administered in life-threatening situations, breast-feeding is not a contraindication to its use. Because many drugs are excreted in human milk, caution should be exercised following Sodium Thiosulfate Injection administration to a nursing woman. There are no data to determine when breastfeeding may be safely restarted following administration of sodium thiosulfate.
","Sodium thiosulfate drug product may contain trace impurities of sodium sulfite. The presence of a trace amount of sulfites in this product should not deter administration of the drug for treatment of emergency situations, even if the patient is sulfite-sensitive.
","Pediatric Use: There are case reports in the medical literature of sodium nitrite in conjunction with sodium thiosulfate being administered to pediatric patients with cyanide poisoning; however, there have been no clinical studies to evaluate the safety or efficacy of sodium thiosulfate in the pediatric population.
Geriatric Use: Sodium thiosulfate is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
","There is limited information about the effects of large doses of sodium thiosulfate in humans. Oral administration of 3 g sodium thiosulfate per day for 1-2 weeks in humans resulted in reductions in room air arterial oxygen saturation to as low as 75%, which was due to a rightward shift in the oxygen hemoglobin dissociation curve. The subjects returned to baseline oxygen saturations 1 week after discontinuation of sodium thiosulfate. A single intravenous administration of 20 mL of 10% sodium thiosulfate reportedly did not change oxygen saturations.
",,,"Store at controlled room temperature between 20°C and 25°C. Protect from direct light. Do not freeze.
",11
+32,Sodium Succinate + Cytochrome C + Adenosine + Nicotinamide,sodium-succinate-cytochrome-c-adenosine-nicotinamide-32,,Drugs for lens opacification,Lens opacification,"This eye drops is used for the treatment of lens opacification.
","Drugs for lens opacification
","Anhydrous Sodium Succinate (intermediate substance) promotes the production of ATP
Cytochrome C is involved in the oxidative phosphorylation for synthesizing ATP from ADP.
Adenosine plays essential role in producing energy required for the vital function of the life lens e.g. the biosynthesis of glutathione, intermembrane active transport of ions and amino acid, the synthesis of DNA, RNA and nucleic acids.
Nicotinamide is said to be involved in the process of creating ATP. NADPH plays a major role in protecting cell against oxidizing agents and from free radicals by maintaining glutathione in its reduced form.
","One drop into the affected eye twice daily.
",,"To avoid interaction with other drugs, it is recommended to inform your doctor of any concomitant treatment particularly with other eye drops.
","This eye drops is contraindicated in patients with known hypersensitivity to any ingredient of the product.
","Like any active ingredient, this drug may cause more or less discomfort in some patients.
","It is recommended to take advice from doctor before using this medicine in pregnancy and lactation.
","Do not inject or swallow. In case of concomitant treatment with another ophthalmic solution, wait 15 minutes between each instillation.
",,"Accidental ingestion of the medicine is unlikely to cause any toxicity due to low content of ingredients. The medication should be kept out of reach of children.
",,,"Store at room temperature and protect from light. It is desirable that the content should not be used more than 4 weeks after first opening of the bottle.
",11
+1281,Sodium Stibogluconate,sodium-stibogluconate-1281,,Leishmaniacides,Visceral leishmaniasis,"For the treatment of various types of a protozoal infection called leishmaniasis, which may result from sandfly bites in tropical and temperate parts of the world. Also investigated for use or treatment in cancer/tumors (unspecified) and solid tumors
","Leishmaniacides
","The mode of action of sodium stibogluconate is not clearly understood. In vitro exposure of amastigotes to 500 mg pentavalent antimony/ml results in a greater than 50% decrease in parasite DNA, RNA protein and purine nucleoside triphosphate levels. It has been postulated that the reduction in ATP (adenosine triphosphate) and GTP (guanosine triphosphate) synthesis contributes to decreased macromolecular synthesis.
","Leishmaniasis: 20 mg/kg/day (maximum 850 mg) intramuscularly or intravenously for 20 to 28 days.
",,,"Hypersensitivity, significant renal impairment, breast feeding
","Sodium stibogluconate is exceedingly toxic to veins. One of the practical problems is that after a few doses it can become exceedingly difficult to find a vein in which to inject the drug. The insertion of a PICC does not prevent the problem and can instead exacerbate it: the entire vein along the course of the PICC line can become inflamed and thrombose. Large doses of sodium stibogluconate are often administered as dilute solutions.
Pancreatitis is a common deleterious effect of the drug, and the serum amylase or lipase should be monitored twice weekly; there is no need to stop treatment if the amylase remains less than four times the upper limit of normal; if the amylase rises above the cut-off, then treatment should be interrupted until the amylase falls to less than twice the upper limit of normal, whereupon treatment can be resumed. Cardiac conduction disturbances are less common, but ECG monitoring while the medicine is injected is advisable and changes quickly reverse after the drug is stopped or the infusion rate is decreased.
The drug can be given intramuscularly but is exceedingly painful when given by this route. It can also be given intralesionally when treating cutaneous leishmaniasis (i.e., injected directly into the area of infected skin) and again, this is exceedingly painful and does not give results superior to intravenous administration.
Sodium stibogluconate can also cause a reduced appetite, metallic taste in mouth, nausea, vomiting, diarrhoea, headache, tiredness, joint pains, muscle aches, dizziness, and anaphylaxis.
","Pregnancy category is not classified.
",,,,,,,7
+1449,Sodium Polystyrene Sulfonate,sodium-polystyrene-sulfonate-1449,https://medex.com.bd/attachments/E4sbsxKZZmhmQ825wm2pwXJL5JClt1/sodium-polystyrene-sulfonate-prescribing-information,Calcium Regulator,Hyperkalemia,"Indicated for the treatment of hyperkalemia. (Hyperkalemia is mainly caused by Acute or Chronic Kidney Disease. Other causes may include Liver failure, Adrenal insufficiency, Use of certain drugs like ARB, ACE inhibitors, Beta blockers or Excessive use of Potassium supplements.)
","Calcium Regulator
","Sodium Polystyrene Sulfonate is a non-absorbed, cation exchange polymer that contains a sodium counterion. Sodium Polystyrene Sulfonate increases fecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract. Binding of potassium reduces the concentration of free potassium in the gastrointestinal lumen, resulting in a reduction of serum potassium levels. The practical exchange ratio is 1 mEq K per 1 gram of resin.
As the resin passes along the intestine or is retained in the colon after administration by enema, the sodium ions are partially released and are replaced by potassium ions. This action occurs primarily in the large intestine, which excretes potassium ions to a greater degree than does the small intestine. The efficiency of this process is limited and unpredictably variable.
","Adults (including the elderly)-
+
+- Oral Dose: The average daily oral dose for adult is 15 gm to 60 gm (1 Sachet 1-4 times daily).
+- Rectal dose: In patients who are unable to intake this medicine orally, rectal administration is possible (as enema). 30 gm to 50 gm of resin is given once or twice daily (at intervals of 6 hours). Each dose is administered as a warm emulsion (at body temperature) in 150 ml to 200 ml of aqueous vehicle (such as plain water, 10% dextrose in water or equal parts of water and 2% Methylcellulose suspension). The emulsion should be agitated gently during administration. The enema should be retained for as long as possible and should be followed by a cleansing enema.
+
+Children-
+
+- Oral dose: In smaller children and infants correspondingly lower doses should be employed. An appropriate initial dose is 1 gm/kg body weight daily in divided doses in acute hyperkalemia. For maintenance therapy, dosage may be reduced to 0.5 gm/kg body weight daily.
+- Rectal dose: When refused by mouth, the resin may be given rectally using a dose at least as much as that which would have been given orally. The resin should be suspended in a proportional amount of 10% Dextrose in water. Following retention of the enema, the colon should be irrigated to ensure adequate removal of the resin.
+
+Neonates-
+
+- Rectal dose: Since it is advised that the oral route should not be employed, only rectal administration should be considered. With rectal administration, the minimum effective dosage within the range of 0.5 to 1 gm/kg of resin should be employed. The resultant suspension should be diluted as for adults. Following administration of the resin, the colon should be adequately irrigated to ensure recovery of the resin.
+
","Mixing procedure: Each dose should be given as a suspension in a small quantity of water or, for greater palatability, in sweetened liquid or syrup (but not with orange or other fruit juices which contain potassium). The amount of fluid usually ranges from 20 ml to 100 ml, depending on the dose. It may be simply determined by allowing 3 ml to 4 ml per gram of drug. The prepared suspension should be administered by placing and maintaining the patient in an upright position. The resin may be introduced into the stomach through a plastic tube. If desired, it may be mixed with a diet appropriate for a patient in renal failure.The intensity and duration of therapy depend upon the severity and resistance of hyperkalemia. Sodium Polystyrene Sulfonate should not be heated because it may alter the exchange properties of the resin.
Suspension of this drug should be freshly prepared and not to be stored beyond 24 hours.
","Sodium Polystyrene Sulfonate may cause drug interactions with Antacids, Non absorbable cation-donating antacids and laxatives, Digitalis, Sorbitol, Lithium, Thyroxine.
","Sodium Polystyrene Sulfonate is contraindicated in the following conditions: patients with hypokalemia, patients with a history of hypersensitivity to polystyrene sulfonate resins, obstructive bowel disease, neonates with reduced gut motility (postoperatively or drug induced) and oral administration in neonates.
","The drug may cause some degree of gastric irritation. Anorexia, nausea, vomiting, and constipation may occur especially if high doses are given. Also, hypokalemia, hypocalcemia, and significant sodium retention, and their related clinical manifestations, may occur. Occasionally diarrhea develops. Large doses in elderly individuals may cause fecal impaction. Rare instances of colonic necrosis have been reported. Intestinal obstruction due to concretions of aluminum hydroxide, when used in combination with such resin has been reported.
","Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Polystyrene Sulfonate. It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.
","Caution is advised when this product is administered to patients who cannot tolerate even a small increase in sodium loads (i.e., severe congestive heart failure, severe hypertension, or marked edema). In such instances compensatory restriction of sodium intake from other sources may be indicated. In the event of clinically signifcant constipation, treatment with this drug should be discontinued until normal bowel motion is resumed. Magnesium-containing laxatives or sorbitol should not be used.
",,"Overdosage may result in electrolyte disturbances including hypokalemia, hypocalcemia, and hypomagnesemia. Biochemical disturbances resulting from overdosage may give rise to clinical signs and symptoms of hypokalemia, including: irritability, confusion, delayed thought processes, muscle weakness, hyporeflexia, which may progress to frank paralysis and/or apnea.
",,,"Store below 30°C. Keep out of the reach of children. Suspension of this drug should be freshly prepared and not to be stored beyond 24 hours.
",12
+1867,Sodium Picosulfate + Magnesium Oxide + Citric Acid,sodium-picosulfate-magnesium-oxide-citric-acid-1867,https://medex.com.bd/attachments/OKiDX2LVQOQ1dj37AQTocDiDjfv9PE/sodium-picosulfate-magnesium-oxide-citric-acid-prescribing-information,Enema & bowel cleansing solution,Cleansing of the colon,"Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid oral solution/powder for oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults and child 9 years & above. Also used in barium enema x-ray exam or surgical procedures that require a clean colon.
","Enema & bowel cleansing solution
",,"There are two dosing regimens, each requires two separate dosing times:
Split-Dose Dosing Regimen (Preferred Method): The Split-Dose regimen is the preferred dosing method. Instruct patients to take two separate doses in conjunction with fluids, as follows:
+
+- Take the first dose (1 bottle/1 sachet) during the evening before the colonoscopy (e.g., 5:00 to 9:00 PM) followed by 1200 ml liquid (5x 240 ml) drinks (using provided measuring cup) of clear liquids before bed. Consume clear liquids within 5 hours.
+- Take second dose (1 bottle/1 sachet) the next day approximately 5 hours before the colonoscopy followed by at least 720 ml (3x240 ml) drinks of clear liquids before the colonoscopy. Consume clear liquids within next 5 hours but atleast 2 hours before the time of the colonoscopy.
+
+
Day-Before Dosing Regimen (Alternative Method): The Day-Before regimen is the alternative dosing method for patients for whom the Split-Dosing is inappropriate. Instruct patients to take two separate doses in conjunction with fluids, as follows:
+
+- Take the first dose (1 bottle/1 sachet) in the afternoon or early evening (e.g., 4:00 to 6:00 PM) before the colonoscopy followed 1200 ml (5x 240 ml) using provided measuring cup of clear liquids before the next dose. Consume clear liquids within 5 hours.
+- Take the second dose (1 bottle/1 sachet) approximately 6 hours later in the late evening (e.g., 10:00 PM to 12:00 AM), the night before the colonoscopy followed by at least 720 ml (3x240 ml) drinks of clear liquids before bed. Consume clear liquids within 5 hours.
+- Additional fluids must be consumed after every dose in both dosing regimens.
+- Instruct patients to consume only clear liquids (no solid food or milk) on the day before the colonoscopy up until 2 hours before the time of the colonoscopy. Instruct patients that if they experience severe bloating, distention, or abdominal pain following the first dose, delay the second dose until their symptoms resolve.
+
",,"
+- Drugs that may increase risks of fluid and electrolyte abnormalities: Use caution when prescribing this solution for patients with conditions or who are using medications that increase the risk for fluid and electrolyte disturbances or may increase the risk of seizure, arrhythmias and prolonged QT in the setting of fluid and electrolyte abnormalities. This includes patients receiving drugs which may be associated with hypokalemia (such as diuretics or corticosteroids, or drugs where hypokalemia is a particular risk, such as cardiac glycosides) or hyponatremia. Use caution when this solution is used in patients on nonsteroidal anti-inflammatory drugs (NSAID) or drugs known to induce Antidiuretic Hormone Secretion (SIADH), such as tricyclic antidepressants, selective serotonin re-uptake inhibitors, antipsychotic drugs and carbamazepine, as these drugs may increase the risk of water retention and/or electrolyte imbalance.
+- Tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine and penicillamine, should be taken at least 2 hours before and not less than 6 hours after administration of this solution to avoid chelation with magnesium.
+- Antibiotics: Prior or concomitant use of antibiotics with this solution may reduce the efficacy of this solution.
+
","This solution is contraindicated in the following conditions:
+
+- Patients with severely reduced renal function (creatinine clearance less than 30 ml/minute) which may result in accumulation of magnesium.
+- Gastrointestinal obstruction or ileus.
+- Bowel perforation
+- Toxic colitis or toxic megacolon
+- Gastric retention
+- An allergy to any of the ingredients in this solution.
+
","Most common adverse reactions (>1%) are nausea, headache and vomiting (abdominal bloating, distension, pain/cramping and watery diarrhea not requiring an intervention were not collected).
","Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this solution should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this solution is administered to a nursing woman.
","Serious Fluid and Serum Chemistry Abnormalities, Advise patients to hydrate adequately before, during and after the use of this solution. Use caution in patients with congestive heart failure when replacing fluids. If a patient develops significant vomiting or signs of dehydration including signs of orthostatic hypotension after taking this solution, consider performing post-colonoscopy lab tests (electrolytes, creatinine and BUN) and treat accordingly. Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias or seizures and renal impairment. Fluid and electrolyte abnormalities should be corrected before treatment with this solution. There have been reports of generalized tonic-clonic seizures with the use of bowel preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g. hyponatremia, hypokalemia, hypocalcemia and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.
","Pediatric Use: The safety and effectiveness of this oral solution in pediatric patients has not been established.
Renal Insufficiency: Patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers or patients of the importance of adequate hydration before, during and after the use of this oral solution. In patients with severely reduced renal function (creatinine clearance <30 mL/min), accumulation of magnesium in plasma may occur.
",,,"This Powder for this oral solution supplied as a powder, must be reconstituted with cold water right before its use. Reconstitution of this Powder. The reconstitution procedure of this powder is as follows:
+
+- Reconstitute the powder right before each administration. Do not prepare the solution in advance.
+- Take 150 ml of cold water in a glass using provided measuring cup and pour in the contents of one packet of this powder.
+- Stir for 2 to 3 minutes. The reconstituted solution may become slightly warm as the powder dissolves.
+- This Oral Solution is supplied as ready to drink oral Solution and no need of reconstitution.
+
","Store at temperature 15°-30°C.
",11
+1480,Sodium Picosulfate,sodium-picosulfate-1480,,Osmotic purgatives,Constipation,"Sodium Picosulfate is indicated in the following conditions-
+
+- Constipation of any etiology
+- Relief from prolonged & recurrent constipation
+- Bowel clearance before surgery, childbirth or radiological investigations.
+
","Osmotic purgatives
","Sodium Picosulfate is a triarylmethane group derivative stimulant laxative. After oral administration it is activated by the colonic bacteria and acts locally in the colon. The active form then stimulates the nerve endings of the intestinal wall and results in colonic peristalsis with promotion of accumulation of water and electrolytes in the colonic lumen. This results in stimulation of defecation, reduction of transit time and softening of the stool. Stimulation of the rectum causes increased motility and a feeling of rectal fullness. The rectal effect may help to restore the ""call to stool"".
","For oral administration. The following dosages are recommended to be taken at night to produce evacuation the following morning. It is recommended to start with the lowest dose. The dose may be adjusted up to the maximum recommended dose to produce regular stools. The maximum recommended daily dose should not be exceeded:
Adults and children over 10 years of age-
+
+- Tablet: 5-10 mg per day.
+- Oral Solution: 5-10 ml or one to two teaspoonful per day.
+
+Children are aged 4-10 years-
+
+- Tablet: 2.5-5 mg per day.
+- Oral Solution: 2.5-5 ml or Half to one teaspoonful per day.
+
+Children under 4 years of age-
+
+- Oral Solution: 0.25 ml/kg body weight per day.
+
",,"The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses are taken. Concurrent administration of antibiotics may reduce the laxative action of this product.
","Ileus or intestinal obstruction, severe painful and/or feverish acute abdominal conditions (e.g. appendicitis) potentially associated with nausea and vomiting, acute inflammatory bowel diseases, severe dehydration, known hypersensitivity to Sodium Picosulfate or any other component of the product.
","Hypersensitivity, dizziness, syncope, vasovagal response, gastrointestinal disorders, diarrhea, abdominal pain and abdominal cramps, nausea, vomiting.
","There are no reports of undesirable or damaging effects during pregnancy or to the foetus attributable to the use of this product. Use of the drug should be avoided during the first trimester. Clinical data show that neither the active moiety of sodium Picosulfate (BHPM or bis-(p hydroxyphenyl)-pyridyl-2-methane) nor its glucuronides are excreted into the milk of healthy lactating females.
","Prolonged excessive use may lead to fluid and electrolyte imbalance and hypokalemia. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.
",,"Laxatives when taken in chronic overdosage may cause chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism, and renal calculi. Renal tubular damage, metabolic alkalosis, and muscle weakness secondary to hypokalemia have also been described in association with chronic laxative abuse.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+1278,Sodium Nitroprusside Dihydrate,sodium-nitroprusside-dihydrate-1278,,Vasodilator antihypertensive drugs,Severe hypertension,"Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with sodium nitroprusside can be minimized ... Read more
Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with sodium nitroprusside can be minimized. Sodium nitroprusside is also indicated for producing controlled hypotension in order to reduce bleeding during surgery. This is also indicated for the treatment of acute congestive heart failure.
","Vasodilator antihypertensive drugs
","Nitroprusside a powerful vasodilator relaxes the vascular smooth muscle and produce consequent dilatation of peripheral arteries and veins. Other smooth muscle (e.g., uterus, duodenum) is not affected. Sodium nitroprusside is more active on veins than on arteries.
One molecule of sodium nitroprusside is metabolized by combination with hemoglobin to produce one molecule of cyanmethemoglobin and four CN- ions; methemoglobin, obtained from hemoglobin, can sequester cyanide as cyanmethemoglobin; thiosulfate reacts with cyanide to produce thiocyanate; thiocyanate is eliminated in the urine; cyanide not otherwise removed binds to cytochromes. Cyanide ion is normally found in serum; it is derived from dietary substrates and from tobacco smoke. Cyanide binds avidly (but reversibly) to ferric ion (Fe+++), most body stores of which are found in erythrocyte methemoglobin (metHgb) and in mitochondrial cytochromes. When CN is infused or generated within the bloodstream, essentially all of it is bound to methemoglobin until intraerythrocytic methemoglobin has been saturated. Once activated to NO, it activates guanylate cyclase in vascular smooth muscle and increases intracellular production of cGMP. cGMP stimulates calcium movement from the cytoplasm to the endoplasmic reticulum and reduces calcium available to bind with calmodulin. This eventually leads to vascular smooth muscle relaxation and vessel dilatation.
","Intravenous Hypertensive crisis:
+
+- Adult: For patients not receiving any antihypertensives, initially 0.3-1.5 mcg/kg/ min, adjust gradually according to response. Usual range 0.5-6 mcg/kg/min. Lower doses should be used in patients receiving antihypertensives. Max rate: 8 mcg/kg/min, discontinue infusion if there is no response after 10 min. May continue for a few hr if there is response. Introduce oral antihypertensive as soon as possible.
+- Child: Initially, 250-500 nanograms/kg/min, rate may be repeatedly doubled at intervals of 15-20 min until the desired effect is achieved or treatment is judged ineffective. Max rate: 6 mcg/kg/min.
+- Elderly: Lower doses may be required.
+
+Induction of hypotension during anaesthesia :
+
+- Adult: Recommended max dose: 1.5 mcg/kg/min.
+
+Heart failure:
+
+- Adult: Intially 10-15 mcg/min, may increase by 10-15 mcg/min every 5-10 min according to response; usual range 10-200 mcg/min. Max: 280 mcg/min.
+
",,"Additive effect when used with other antihypertensives. May prolong the fibrinolytic activity of alteplase. Risk of severe hypotension if used with phosphodiesterase inhibitors. May reduce serum digoxin levels.
","Sodium nitroprusside should not be used in the treatment of compensatory hypertension, where the primary hemodynamic lesion is aortic coarctationor arteriovenous shunting.
Sodium nitroprusside should not be used to produce hypotension during surgery in patients with known inadequate cerebral circulation, or in moribund patients (A.S.A. Class 5E) coming to emergency surgery.
Patients with congenital (Leber's) optic atrophy or with tobacco amblyopia have unusually high cyanide/thiocyanate ratios. These rare conditions are probably associated with defective or absent rhodanase, and sodium nitroprusside should be avoided in these patients.
Sodium nitroprusside should not be used for the treatment of acute congestive heart failure associated with reduced peripheral vascular resistance such as high-output heart failure that may be seen in endotoxic sepsis.
","Bradyarrhythmia, hypotension, palpitations, tachyarrhythmia Apprehension, restlessness, confusion, dizziness, headache, somnolence Rash, sweating, Thyroid suppression, Injection site irritation, Muscle twitch, oliguria, renal azotemia, Cardiac dysrhythmia, hemorrhage, decreased platelet aggregation, excessive hypotensive response, Raised intracranial pressure, Metabolic acidosis, Bowel obstruction, Methemoglobinemia, Cyanide poisoning, Thiocyanate toxicity
","Pregnancy Category C. There are no adequate, well-controlled studies of Sodium Nitroprusside in either laboratory animals or pregnant women. It is not known whether Sodium Nitroprusside can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Sodium Nitroprusside should be given to a pregnant woman only if clearly needed.
Nursing Mothers: It is not known whether sodium nitroprusside and its metabolites are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from sodium nitroprusside, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","Hypothyroidism, renal and hepatic impairment, ischaemic heart disease, impaired cerebral circulation, elderly. Monitor blood thiocyanate concentration if treatment is longer than 3 days and should not exceed 100 mcg/ml. Monitor acid-base balance, venous oxygen concentration and BP. Caution to avoid extravasation. To be diluted with sterile dextrose 5% solution before infusion. Avoid sudden withdrawal. Leber's optic atrophy, low plasma-cobalamin concentrations, impaired pulmonary function. Pregnancy and lactation.
","Renal impairment: Dosage adjustments may be necessary
",,,,,10
+1264,Sodium Hypochlorite,sodium-hypochlorite-1264,,Bleaching and Disinfectants,Wound and burn dressing,"Sodium Hypochlorite is indicated in diabetic foot ulcer, necrotic wound infections, post-surgical wounds, first, second and third degree burns, pressure ulcer, and grafted and donor sites. This solution is safe to use around the eyes, nose and mouth.
","Bleaching and Disinfectants
","Hypochlorous acid, is a powerful oxidizing agent (meaning it can accept electrons from other materials) that lends hypochlorite excellent bleaching and disinfecting abilities.
","Use as required. This may require a secondary cover dressing.
",,"There are no known drug interactions and none well documented.
","No known contraindications
",,"Pregnancy Category: Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
","Wound healing rates and characteristics will vary significantly with patient age, nutritional status, metabolic status, immunologic status and compliance. In the presence of vascular compromise, care must be taken to avoid circumferential bandage compression pressures in excess of arterial perfusion pressures.
",,,,,,8
+1602,Sodium Hyaluronate + Carboxymethylcellulose Sodium,sodium-hyaluronate-carboxymethylcellulose-sodium-1602,,Drugs for Dry eyes,Dry eye,"This eye drops is useful for the instant relief of dry, irritated and gritty eyes which is compatible with contact lenses.
","Drugs for Dry eyes
","This eye drops have a unique formula that blends several ocular lubricants (Sodium Hyaluronate and Carboxymethylcellulose) to lubricate, protect and restore eye surface integrity. Sodium Hyaluronate is a natural polymer with viscoelastic property that promotes healing and guards against dehydration on the eye surface. Carboxymethylcellulose is one of the strongest mucoadhesive polymers, which retains direct contact with corneal epithelial cells to provide long-lasting clinical benefits.
","Instill 1 or 2 drops in the affected eye(s) as needed.
",,,"This eye drops is contraindicated in patients who are hypersensitive to any component of this preparation.
","The chance of side effect is highly unlikely. However, transient blurring of vision may occur.
","There are no adequate and well-controlled studies in pregnant women. This eye drops should be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. It is not clear if enough medication from the eye drops would pass into breast milk. Caution should be exercised while giving this ophthalmic solution to a nursing mother.
","
+- For ophthalmic use only.
+- To avoid possible contamination of the drops, do not touch the dropper tip or to any surface. Replace the cap after use.
+- Do not use if solution changes color or becomes cloudy.
+- If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes interval between applications.
+
","Pediatric use: Safety and effectiveness have not been demonstrated with this eye drops in pediatric patients.
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+1355,Sodium Hyaluronate (Ophthalmic),sodium-hyaluronate-ophthalmic-1355,,Drugs for Dry eyes,Lubrication,"Sodium Hyaluronate 0.1% sterile ophthalmic preparation is indicated for all forms of dry eye and for post-surgical lubrication. Sodium Hyaluronate 0.2% sterile ophthalmic preparation is indicated for severe & chronic dry eye including after surgery. Both strengths are also indicated for dry eye ... Read more
Sodium Hyaluronate 0.1% sterile ophthalmic preparation is indicated for all forms of dry eye and for post-surgical lubrication. Sodium Hyaluronate 0.2% sterile ophthalmic preparation is indicated for severe & chronic dry eye including after surgery. Both strengths are also indicated for dry eye associated with contact lens user.
Sodium Hyaluronate eye drops provide intensive and long-lasting lubrication for severe cases of dry eyes. The drops have a highly viscous consistency and are therefore ideal for the special needs of severe and chronic eye symptoms. In addition, they are outstandingly well-suited to supporting the healing of eyes following an operation. Sodium Hyaluronate lubricating eye drops can be prescribed for some diseases because of their therapeutic properties. In these cases, they can be prescribed by the doctor and the costs can be paid by health insurance funds. Sodium Hyaluronate eye drops contain the ingredient hyaluronan and are free from preservatives and phosphates. That is why Sodium Hyaluronate lubricating eye drops have very good tolerability.
","Drugs for Dry eyes
","Sodium hyaluronate is a polysaccharide which functions as a tissue lubricant. It is widely used in ophthalmic surgery because it forms a viscoelastic solution in water which makes it a suitable substitute for aqueous and vitreous humour.
","Adult: Instill 1 drop 3 times daily. If necessary this can be increased or as directed by a physician.
Use in children: There is no known experience with patients under 18 years old.
",,,"Known hypersensitivity to any of the components.
","Transient burning sensation, temporarily blurred vision and transient rise in intraocular pressure. Precautions: To avoid contamination, the tip of the container should not touch any surface and should be fully closed between applications.
","Pregnancy category B. Reproductive studies have not demonstrated any risk, but no controlled studies in pregnant women are available. Sodium Hyaluronate has a purely physical effect on the eyes without being absorbed and hence can be used during pregnancy and lactation.
",,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",8
+1002,Sodium Hyaluronate (Injection),sodium-hyaluronate-injection-1002,https://medex.com.bd/attachments/q2ruXIfR6cGbxd2hRLHnP7W8UYsUUo/sodium-hyaluronate-injection-prescribing-information,Drugs for Osteoarthritis,Surgical aid in the anterior segment,"Sodium Hyaluronate is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy, and to simple analgesics, e.g., acetaminophen.
","Drugs for Osteoarthritis
","Sodium hyaluronate is a polysaccharide which functions as a tissue lubricant. It is widely used in ophthalmic surgery because it forms a viscoelastic solution in water which makes it a suitable substitute for aqueous and vitreous humour.
","Sodium Hyaluronate is administered by intra-articular injection. A treatment cycle consists of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly intervals. Inject the full 2 ml in one knee only. If treatment is bilateral, a separate injection should be used for each knee.
",,,"The drug is contraindicated in patients with known hypersensitivity to hyaluronate preparations. Intra-articular injections are contraindicated in cases of past and present infections or skin diseases in the area of the injection site.
","The common side-effects include gastrointestinal complaints, injection site pain, knee swelling/effusion, local skin reactions (rash, ecchymosis), pruritus, and headache.
","The safety and effectiveness of Sodium Hyaluronate have not been established in pregnant women. It is not known if Sodium Hyaluronate is excreted in human milk. The safety and effectiveness of Sodium Hyaluronate have not been established in lactating mother. The safety and effectiveness of Sodium Hyaluronate have not been demonstrated in children.
","Use caution when injecting Sodium Hyaluronate into patients who are allergic to avian proteins, feathers, and egg products. Strict aseptic administration technique must be followed. Remove joint effusion, if present, before injecting Sodium Hyaluronate. Do not use the same syringe for removing joint effusion and for injecting Sodium Hyaluronate. It is recommended that the patient avoid any strenuous activities or prolonged (i.e., more than 1 hour) weight-bearing activities such as jogging or tennis within 48 hours following the intra-articular injection.
",,"No case of over dosage has been reported to date.
",,,"Hyronate injection should be stored in a cool (below 25° C) and dry place and protected from light. Protect from freezing.
",10
+1001,Sodium Fusidate (Topical),sodium-fusidate-topical-1001,,Topical Antibiotic preparations,Varicose ulcers,"Sodium Fusidate Ointment is indicated for treatment of skin infections caused by Staphylococci, Streptococci, Corynebacterium minutissimum and other Fusidate sensitive organisms. The most important indications being: impetigo, boils, abscess, varicose ulcers, skin grafts, hidradenitis, infected wounds, sycosis barbae, paronychia, folliculitis, carbuncles and erythrasma.
","Topical Antibiotic preparations
","Sodium Fusidate, an antibiotic derived from Fusidium coccineum, exerts powerful activity against a number of gram-positive organisms. Staphylococci, including the strains resistant to penicillin or other antibiotics, are particularly susceptible to Sodium Fusidate. The therapeutic efficacy of topically applied Sodium Fusidate is due partly to the pronounced antibacterial activity of Sodium Fusidate against the organisms responsible for skin infection and partly to the unique ability of this antibiotic to penetrate intact skin.
Fusidic Acid is an anti-microbial agent that acts as an inhibitor of protein synthesis in the microorganism. It interferes with the translocation step by stabilizing the ribosome-guanosine dephosphate elongation factor G-complex. This prevents binding of aminoacyl t-RNA to the ribosome and thereafter stops transfer of additional amino acids to the growing polypeptide.
","Sodium Fusidate Ointment or cream is applied to the affected areas 2 to 3 times daily, generally for a period of 7 days. It can be used with or without a covering dressing. Caution should be observed when applying Sodium Fusidate Ointment near the eye region as this preparation may cause irritation if it gets into the eye. No special dosage modifications or special precautions are required for children.
",,,"Known hypersensitivity to Sodium Fusidate, severe hepatic failure.
","Sodium Fusidate Ointment is remarkably well tolerated, and there is an extremely low frequency of hypersensitivity reactions.
","Data no found
","Caution should be observed when applying Sodium Fusidate ointment in the eye region as this preparation may cause irritation upon contact with the eye.
",,,,,,8
+1181,Sodium Fusidate (Oral),sodium-fusidate-oral-1181,,,Susceptible infections,"Treatment of infections caused by susceptible organisms especially Staph eg, osteomyelitis, septicaemia, endocarditis, superinfected cystic fibrosis, pneumonia, skin & soft tissue infections, surgical & traumatic wound infections.
","Other antibiotic
","Fusidic acid inhibits bacterial protein synthesis by interfering with amino acid transfer from aminoacyl-tRNA to protein on the ribosomes.
","Adult: 250-500 mg every 8 hourly
Skin & soft tissue infection: 250 mg twice daily.
",,"Drugs metabolized by CYP450 isoenzymes.
","Hypersensitivity
","GI disturbances eg, dyspepsia, nausea, vomiting, epigastric pain, anorexia; jaundice & change of liver function.
","No data found
","Hepatic impairment, biliary obstruction or disease. Monitor hepatic function periodically in patients on high or prolonged oral doses. Avoid during 3rd trimester of pregnancy. Lactation. Premature, jaundiced, acidotic or seriously ill neonates.
",,,,,,9
+1000,Sodium Fluoride (Mouthwash),sodium-fluoride-mouthwash-1000,,Anticavity Mouthwash,Dental caries,"Sodium fluoride is an antiseptic & anticavity mouthwash which-
+
+- Restores enamel to strengthen teeth
+- Protects teeth from cavity
+- Helps to prevent tooth decay
+- Controls tartar that can discolor teeth
+- whitens teeth safety
+
","Anticavity Mouthwash
","Sodium fluoride is a cariostatic agent that is used to prevent dental caries. It can also be used as a source of fluoride in total parenteral nutrition.
","Rinse (gargle) with fall strength Sodium fluoride for 30 seconds with 20 ml (with the help of supplied cup) two times daily (morning and evening). Do not swallow. Don’t eat or drink within 30 minutes after rinsing with Sodium fluoride restoring.
",,"Absorption of fluoride may be reduced by aluminium, calcium and magnesium salts.
","Not to use 1 mg tablets in children less then 3 yr of age or when drinking water fluoride content is >= 0.3 ppm.
","Hypersensitivity reactions, rash, nausea, vomiting. Products containing stannous fluoride may cause teeth staining.
","No data found
","Prolonged treatment with large amounts of fluoride may result in dental fluorosis and osseous changes; do not exceed recommended dosage. Renal impairment. Pregnancy.
",,"In acute poisoning, symptoms include a salty or soapy taste, increased salivation, GI disturbances, abdominal pain, weakness, drowsiness, faintness and shallow breathing; more serious effects include hypocalcaemia, hypomagnesaemia, hyperkalaemia, tremors, convulsions, cardiac arrhythmias, shock, respiratory arrest and cardiac failure. Death may occur within 2-4 hr. Treatment includes gastric lavage with lime water or a weak solution of another calcium salt to precipitate fluoride. Maintain high urine output, slow IV inj of calcium gluconate 10% may be used for hypocalcaemia and tetany. Magnesium sulfate may be given to treat hypomagnesaemia, and aluminium hydroxide may help to reduce fluoride absorption. Haemodialysis may be considered. Chronic fluoride poisoning may cause skeletal fluorosis resulting in bone pain, stiffness, limited movment and in severe cases, crippling deformities. In children, prolonged excessive intake during tooth development before eruption may cause dental fluorosis characterised by mottled enamel.
",,,"Store in tight plastic containers.
",11
+372,Sodium Dihydrogen Phosphate + Disodium Hydrogen Phosphate,sodium-dihydrogen-phosphate-disodium-hydrogen-phosphate-372,,Enema & bowel cleansing solution,Constipation,"This is an stable clear, colorless, buffered, ginger-lemon flavored, aqueous oral solution, that is used to treat relief of occasional constipation, bowel cleansing regimen in preparing the patient for surgery or for preparing the colon for X-Ray or endoscopic examination.
","Enema & bowel cleansing solution
","Sodium phosphate can be used in the management of hypophosphataemia. It also acts as a mild osmotic laxative when given orally as dilute solutions or by the rectal route. Phosphate enemas or concentrated oral solutions are used for bowel cleansing before surgery or endoscopy procedures.
","Dose for bowel preparation-
+
Adults and children 5 years of age & over: The recommended dosage for adults and children 5 years of age & over is 45 ml and repeated 10 to 12 hours later. The intake of clear liquids is an essential part of this regimen. On the day before the procedure, the patient should only take clear liquids for breakfast, lunch and dinner and between doses. No solid food, milk or milk products should be taken on the day before the procedure. The patient should not drink anything colored red or purple. Medical procedure is intended to be performed at early morning, mid-morning or later, by two alternative dosage regimens.
Early morning procedure: The first dose is taken at 7 a.m. on the morning before the procedure. The second dose is taken at 7 p.m. on the evening before the procedure.
Mid-morning (or later) procedure: The first dose is taken at 7 p.m. on the evening before the procedure. The second dose is taken at 7 a.m. (or at least 3 hours before leaving for the appointment) on the morning before the procedure.
+
+- First dose: Mix 15 ml (one third of the bottle) of This into a full glass (approximately 250 ml) of clear liquids and drink. Repeat two more times within the next 20 minutes.
+- Between Doses: Between the first and second doses, the patient should drink at least three more glasses (approximately��250 ml each) of clear liquids or more if desired to prevent dehydration and to ensure that their bowel remains easily examinable for the procedure.
+- Second Dose: Mix 15 ml of This into a full glass of clear liquid and drink. Repeat two more times within the next 20 minutes. Please refer to clear liquids list below. Beverages, water, tea or coffee (no milk or non dairy creamer), sweeteners are acceptable, carbonated or non carbonated soft drinks (not colored red or purple) fruit flavored cordials (not colored red or purple) and strained fruit juices without pulp. Do not drink any alcoholic beverage.
+
+
Dose for occasional constipation-
+Adult/child over:
+
+- 12 years old: 20-45 ml
+- 10-11 years old child: 10-20 ml
+- 5-9 years old child: 5-10 ml
+
",,"Use with caution in patients taking calcium channel blockers, diuretics, angiotensin converting enzyme inhibitors (ACE-Is), angiotensin receptor blockers (ARBs), non-steroidal anti-inflammatory drugs (NSAIDs), and lithium preparations or other medication that might affect electrolyte levels, as hyperphosphataemia, hypocalcaemia, hypernatraemic dehydration and acidosis may occur. Concurrent administration of polyethylene glycol bowel cleansing preparations and this solution may be dangerous and is not recommended.
","CHF, renal failure or clinically significant impaired renal function, congenital or acquired megacolon, bowel/GI obstructions, ascites, perforation of ileus, active inflammatory bowel disease.
","Gastrointestinal side effects of sodium biphosphate and sodium phosphate have included bloating (31% to 41%), nausea (26% to 30%), abdominal pain (23% to 25%), and vomiting (4% to 9%). Nervous system side effects have included dizziness, headache, and seizures. Renal side effects have included renal impairment, increased blood urea nitrogen (BUN), increased creatinine, acute renal failure, acute phosphate nephropathy, nephrocalcinosis, and renal tubular necrosis. Hypersensitivity reactions reported have included anaphylaxis, rash, pruritus, urticaria, throat tightness, bronchospasm, dyspnea .
","Use in pregnancy: Because of potential harm to the fetus from phosphate absorbed across the placenta, the use of this product is not recommended in pregnant women unless the probable clinical benefit outweighs the possible risk.
Use in lactation: Because of potential harm to the infant from phosphate excreted in breast milk, the use of this product is not recommended in nursing mothers unless the probable clinical benefit outweighs the possible risk.
","This solution should be used with extreme caution, in the elderly, the frail or debilitated, patients with colostomy and this solution patients on a low salt diet, as they are particularly at risk. These patients should receive additional fluids by mouth, both prior to, and after administration of this solution, to ensure that dehydration does not occur. Patients undergoing major bowel procedures, who are on nil by mouth for significant periods of time, should have their electrolytes monitored and receive intravenous fluids containing potassium and calcium, prior to surgery. Use with caution in patients taking diuretics and in patients using medicines known to prolong the QT interval. Concurrent administration of polyethylene glycol bowel cleansing preparations and this solution may be dangerous and is not recommended. Patients should be advised not to use this solution when nausea, vomiting or abdominal pain are present, unless directed by a physician.
","Use in children: This is not to be taken by children under 5 years of age.
Use in diabetics:As the liquid diet during the period of administration and prior to bowel surgery, X-Ray of the colon or colonoscopy may affect the diabetic patients’ glucose blood levels, adjustment of their insulin or oral anti-diabetic medication may be necessary.
",,,,"Store in a cool and dry place, procted from light. Keep out of children’s reach.
",11
+1024,Sulphamethoxazole + Trimethoprim,sulphamethoxazole-trimethoprim-1024,https://medex.com.bd/attachments/b1qnx9wxCc5EpK7Bu82dVa93KGt9EX/sulphamethoxazole-trimethoprim-tablets-prescribing-information,Sulphonamides & Trimethoprim,Urinary tract infection,"Cotrimoxazole is bactericidal in vitro to a wide range of Gram-positive and Gram-negative organisms, including Streptococcus, Staphylococcus, Pneumococcus, Neisseria, B. catarrhalis, Escherichia coli, Klebsiella, Proteus spp., Haemophilus, Salmonella, Shigella, Vibrio cholerae, Brucella, Pneumocystis ... Read more
Cotrimoxazole is bactericidal in vitro to a wide range of Gram-positive and Gram-negative organisms, including Streptococcus, Staphylococcus, Pneumococcus, Neisseria, B. catarrhalis, Escherichia coli, Klebsiella, Proteus spp., Haemophilus, Salmonella, Shigella, Vibrio cholerae, Brucella, Pneumocystis carinii, Nocardia and Bordetella. A particularly high degree of activity is exhibited against Haemophilus influenzae, E. coli and Proteus spp., making Cotrimoxazole particularly suitable for the treatment of chronic bronchitis and urinary tract infections. Cotrimoxazole exerts its bactericidal action by the sequential blockade of two bacterial enzyme systems in the biosynthesis of Folinic acid in the micro-organisms. The synergy thus produced accounts for the high degree of bactericidal activity.
Indications are :
+
+- Respiratory tract infections, including acute and chronic bronchitis (treatment and prophylaxis), bronchiectasis, lung abscess, lobar and broncho-pneumonia, Pneumocystis carinii pneumonitis, sinusitis and otitis media.
+- Genito-urinary tract infections, including urethritis, acute and chronic cystitis, pyelonephritis, prostatitis and gonorrhoea.
+- Gastro-intestinal tract infections, caused by Salmonella typhi and Salmonella paratyphi, including the chronic carrier state.
+- Other infections, caused by a wide range of organisms confirmed to be susceptible to Cotrimoxazole and where the therapeutic benefits are considered to outweigh the possible occurrence of adverse events.
+- Such infections include acute and chronic osteomyelitis, acute brucellosis, skin infections including pyoderma, abscesses and wound infections, septicaemia, bacillary dysentery and cholera (as an adjuvant to fluid and electrolyte replacement), nocardiosis and mycetoma.
+
","Anti-diarrhoeal Antimicrobial drugs, Sulphonamides & Trimethoprim
","Cotrimoxazole having broad spectrum bactericidal activity against a wide range of gram-positive & gram-negative bacteria and some protozoa. Co-trimoxazole containing Trimethoprim and Sulphamethoxazole in a 1:5 combination exerts its bactericidal action by the sequential blockade of two bacterial enzyme systems in the biosynthesis of folinic acid in the microorganism.
","Cotrimoxazole double strength tablet: Over 12 years
+
+- For mild to moderate infections: 1 tablet twice daily.
+- For severe infections: 1.5 tablets twice daily.
+- Long term therapy (>14 days): 0.5 tablet twice daily.
+- Gonorrhoea: 2 tablets every 12 hours for two days or 2.5 tablets followed by a further dose of 2.5 tablets after 8 hours.
+
+Cotrimoxazole tablet: over 12 years
+
+- For mild to moderate infections: 2 tablets twice daily.
+- For severe infections: 2 tablets thrice daily.
+- Long term therapy: (>14 days): 1 tablet twice daily.
+
+Cotrimoxazole suspension: Under 12 years
+
+- 6-12 years: 2 teaspoonful twice daily.
+- 6 month-5 years: 1 teaspoonful twice daily.
+- 6 weeks-6 months: 0.5 teaspoonful twice daily.
+
",,,"
+- Hypersensitivity to trimethoprim or sulphonamides.
+- Patients with documented megaloblastic anaemia due to folate deficiency.
+- Patients showing marked liver parenchymal damage, blood dyscrasia, severe renal insufficiency, glucose 6-phosphate dehydrogenase deficiency.
+
","The side effects like crystalluria, allergic reactions, haemolysis, thrombocytopenia, neutropenia, agranulocytosis etc. have been reported rarely with Sulphamethoxazole-Trimethoprim combination. Other side effects are less serious in nature such as malaise, headache, nausea and vomiting. These are normally transient and do not require withdrawal of treatment.
","Pregnancy and during the nursing period, because sulphonamides pass the placenta and are excreted in the breast milk and may cause kernicterus.
","Prolonged full dose treatment with sulfamethoxazole-trimethoprim combination is associated with the risk of macrocytic anaemia due to the drug’s interference in the conversion of Folic acid into Folinic acid. If this occurs, it can be reversed by giving Folinic acid. Care should be taken when giving this combination to diabetic patients receiving sulphonylurea drug for possible potentiation of action of sulphonylurea.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+938,Sulphadoxine + Pyrimethamine,sulphadoxine-pyrimethamine-938,https://medex.com.bd/attachments/G1OxfH7lvu2Hjek1VJVI1hCbrWQgpS/sulphadoxine-pyrimethamine-prescribing-information,Anti-malarial drugs,Chloroquine-resistant falciparum malaria,"Treatment of all forms of malaria due to Plasmodium falciparum, Plasmodium vivax, Plasmodium malariae. The drug is also indicated for suppressive or prophylactic management, particularly in areas where resistance to chloroquine is known to exist.
","Anti-malarial drugs
","Sulphadoxine & Pyrimethamine is an antimalarial agent embodying the concept of synergism. Individually the components of this preparation exert inferior result with higher doses in comparison with that obtained with the combination. Moreover, this preparation is effective against strains that are resistant to other antimalarial agents and the risk of resistance development is minimum with this preparation. It is extremely long acting drug, attacks the different development stages of the parasite and attains effective concentration with a single dose. The protective effect of a single dose lasts for approximately four weeks and this preparation is compatible with other antimalarial drugs and with antibiotics. It does not influence the action of antidiabetic agents.
","Curative treatment of malaria with a single dose-
+
+- Adults: 2-3 tablets
+- Children under 4 years: ½ tablets
+- 4-8 years: 1 tablet
+- 9-14 years: 2 tablets
+
+In severe cases, Sulphadoxine & Pyrimethamine can be beneficially combined with quinine.
+
Suppressive or prophylactic management-
+The dose given below should be taken at one time:
For semi-immune subjects (Dose: once every four weeks)-
+
+- Adults: 2-3 tablets
+- Children under 4 years: ½ tablets
+- 4-8 years: 1 tablet
+- 9-14 years: 2 tablets
+
+For non-immune subjects (Dose: Once every two weeks)-
+
+- Adults: 2 tablets
+- Children under 4 years: 1½ tablets
+- 4-8 years: 1 tablet
+- 9-14 years: 1½ tablets
+
+For malaria prophylaxis: The first dose of Sulphadoxine & Pyrimethamine should be taken one or two days before departure for an endemic area in order to protect tolerance, administration should be continued in the above dosage during the stay and also for four weeks after return or as prescribed by the physician.
",,"Concurrent administration of other preparations containing folate antagonists (e.g. cotrimoxazole, methotrexate, anticonvulsants) can result in increased impairment of folic acid metabolism, which leads to haematological side effects.
","Prophylactic (repeated) use of Pyrimethamine + Sulphadoxine is contraindicated in patients with severe renal insufficiency, marked liver parenchymal damage or blood dyscrasias. Treatment must be immediately discontinued upon the appearance of any mucocutaneous signs or symptoms such as pruritus, erythema, rash, orogenital lesions or pharyngitis.
","Sulphadoxine & Pyrimethamine at the recommended dose is well tolerated. Main side effects are given below
+
+- Skin reactions: Drug rash, pruritus and slight hair loss have been observed.
+- Gastro-intestinal reactions: Feeling of fullness, nausea, rarely vomiting, stomatitis.
+- Haematological reactions: In rare cases, leukopenia, thrombocytopenia, and megaloblastic anemia have been observed.
+- Other reactions: Fatigue, headache, fever, polyneuritis may occasionally occur.
+
","Sulphadoxine & Pyrimethamine is contraindicated during pregnancy, premature and newborn infants during the first weeks of life and intolerance to sulfonamide. If pregnancy can not be excluded, possible risks should be balanced against therapeutic effect. Both Pyrimethamine and Sulphadoxine are excreted in maternal breast milk. Nursing mother should not take this preparation.
","Impaired renal or hepatic function, folate deficiency, severe allergy or bronchial asthma, G6PD deficiency, pregnancy. Take with plenty of water to prevent crystalluria. Avoid excessive exposure to sun. Discontinue at the first sign of rash. Discontinue if signs of folic acid deficiency develops. Regular CBC monitoring, LFT, analysis of urine for crystalluria when admin for > 3 mth. Take with food to minimise Gi effects (e.g. anorexia and vomiting).
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+1022,Sulindac,sulindac-1022,https://medex.com.bd/attachments/mlIiteFYPNpT9RpgBMmBf2ESPWheoS/sulindac-prescribing-information,Drugs for Osteoarthritis,Rheumatoid arthritis,"Sulindac is indicated for the symptomatic treatment of-
+
+- Rheumatoid arthritis
+- Osteoarthritis
+- Ankylosing spondylitis
+- Periarticular inflammatory disorders
+- Acute painful shoulder
+- Acute gouty arthritis
+- Diabetic neuropathy
+- Diabetic retinopathy
+
","Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Drugs used in Gout, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Sulindac is a non-steroidal antirheumatic agent possessing anti-inflammatory, analgesic and anti-pyretic properties. Prostaglandin synthetase inhibition is probably the basis of the mechanism of action of non-steroidal anti-inflammatory agents. Following absorption, Sulindac undergoes two major transformations. It is oxidised to the sulphone and then reversibly reduced to the sulphide. The sulphide metabolite is the biologically active form which is an inhibitor of prostaglandin synthesis.
","Sulindac should be administered orally twice a day with food. The maximum dosage is 400 mg per day. Dosages above 400 mg per day are not recommended. In osteoarthritis, rheumatoid arthritis & ankylosing spondylitis, the recommended starting dosage is 150 mg. In acute painful shoulder & acute gouty arthritis the recommended dosage is 200 mg twice a day. The dosage may be lowered or raised depending on the response. After a satisfactory response has been achieved, the dosage may be reduced according to the response. Or, as directed by the registered physicians.
",,"Sulindac and its sulphide metabolite are highly protein bound. Patient should be monitored carefully until it is certain that no chance in their anticoagulant or hypoglycemic dosage is required. Aspirin has been shown to decrease the bioavailability of the active sulfide metabolite of sulindac. Prolonged concurrent use of Paracetamol with sulindac may increase the risk of adverse renal effects. That patient is under close medical supervision while receiving such combined therapy. Probenecid may increase the plasma concentration of sulindac and its sulfone metabolite and slightly decrease the plasma concentration of the active sulfide metabolite.
","Patients known to be allergic to Sulindac and those in whom acute asthmatic attacks, urticaria or rhinitis have been precipitated by Aspirin or other non-steroidal anti-inflammatory agents. Sulindac is also contraindicated in patients with a history of active gastro-intestinal bleeding or peptic ulceration. It should not be given to children, pregnant or lactating women.
","Gastrointestinal side effects are the most common and consist of abdominal pain, nausea and constipation. Gastrointestinal ulceration and bleeding may also occur. The most frequently reported central nervous system side effects are drowsiness, dizziness, headache and nervousness. Other adverse effects include depression, tinnitus, confusion, light-headedness, insomnia, psychiatric disturbances, syncope, convulsions, coma, peripheral neuropathy, blurred vision and other ocular effects, oedema and mass gain, hypertension, hematuria, skin rashes, pruritus, urticaria, stomatitis, alopecia and hypersensitivity reactions. A hypersensitivity syndrome consisting of fever and chills, skin rashes or other cutaneous manifestations, hepatotoxicity, renal toxicity (including renal failure), leukopenia, thrombocytopenia, eosinophilia, inflammed glands or lymph nodes, and arthralgia have been reported. Leucopenia, purpura, thrombocytopenia, aplastic anaemia, haemolytic anaemia, agranulocytosis, epitaxis, hyperglycaemia, hyperkalaemia and vaginal bleeding have been reported. There have also been reports of hepatitis and jaundice or renal failure.
","Use in pregnancy: Sulindac should be used during the first two trimesters of pregnancy only if the potential benefit justifies the potential risk to the foetus. Use of Sulindac during the third trimester of pregnancy is not recommended.
Use in lactation: It is not known whether Sulindac is excreted in human milk. So a decision should be made whether to discontinue nursing or discontinue the medicine taking into account the importance of the medicine to the mother.
","Sulindac should be administered with caution to patients with impaired renal function and bleeding disorders, epilepsy, parkinsonism or psychiatric disorders. Patient with hepatic impairment the half life of sulindac is prolonged and a reduction of daily dosage may be required. Anemia is some time seen in patients receiving NSAIDs with sulindac.
","Patient with renal impairment: Sulindac should be administered with caution to patients with impaired renal function and to those with bleeding disorders, epilepsy, parkinsonism or psychiatric disorders.
Patient with hepatic impairment: In the presence of liver function impairment the half life of Sulindac is prolonged and a reduction of daily dosage may be required.
","Reported symptoms have generally reflected the gastro-intestinal, renal and central nervous system toxicities of Sulindac. Treatment is symptomatic and supportive.
",,,"Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.
",12
+1021,Sulfinpyrazone,sulfinpyrazone-1021,,Drugs used in Gout,Hyperuricaemia,"Sulphinpyrazone is indicated for the treatment of: Chronic gouty arthritis, Intermittent gouty arthritis
","Drugs used in Gout
","Sulfinpyrazone increases urinary excretion of uric acid by competitively inhibiting tubular reabsorption of uric acid, thus lowering serum urate concentration and eventually reducing urate deposits in the tissues.
","Initial dose: 200-400 mg daily in two divided doses, with meals or milk, gradually increasing when necessary to full maintenance dosage in one week.
Maintenance dose: 400 mg daily, given in two divided doses, as above. This dosage may be increased to 800 mg daily, if necessary, and may sometimes be reduced to as low as 200 mg daily after the blood urate level has been controlled. Treatment should be continued without interruption even in the presence of acute exacerbations, which can be concomitantly treated with phenylbutazone or colchicine. Patients previously controlled with other uricosuric therapy may be transferred to Anturane (sulfinpyrazone) at full maintenance dosage.
",,"Decreased therapeutic effect when given with drugs that increase uric acid concentration (e.g. diuretics, pyrazinamide). May potentiate the action of coumarin anticoagulants (e.g. warfarin, acenocoumarol), hypoglycaemic agents and sulfonamides. May decrease plasma levels of theophylline. May increase plasma levels of penicillins and phenytoin. Increased risk of haemorrhage with substances affecting homeostasis (e.g. non-steroidal antirheumatic drugs). Probenecid may inhibit renal tubular secretion of sulfinpyrazone.
","Patients with an active peptic or symptoms of gastro-intestinal inflammation or ulceration should not receive the drug. The drug is contraindicated in patients with a history or the presence of hypersensitivity to phenylbutazone or other pyrazoles.
","The symptoms are upset stomach, vomiting, loss of appetite and joint pain. If you experience any of the following symptoms like difficulty in breathing, tightness in the chest, skin rash, unusual bleeding, fever, sore throat and mouth sores, call your doctor immediately.
","Pregnancy category C. This means that it is not known whether Sulphinpyrazone will harm an unborn baby. Don't take this without first talking to your doctor if you are pregnant.
It is also not known whether Sulphinpyrazone passess into breast milk. Do not take it without first talking to your doctor if you are breast-feeding a baby.
","Patients receiving Sulphinpyrazone should be kept under close medical supervision and periodic blood counts are recommended. It may be administered with care to patients with a history of healed peptic ulcer. It is suggested that Sulphinpyrazone should be used with caution in conjunction with sulfa drugs, the sulfonylurea hypoglycemic agents and insulin. Because Sulphinpyrazone is a potent uricosuric agent, it may precipitate urolithiasis and renal colic, especially in the initial stages of therapy. For this reason, an adequate fluid intake and alkalinization of the urine are recommended. Salicylates antagonize the uricosuric action of Sulphinpyrazone and for this reason, their concomitant uses are contraindicated in gouty arthritis.
","Renal Impairment: Mild to moderate: Reduce dose. Severe: Contraindicated.
Hepatic Impairment: Severe: Avoid.
","Symptoms: Nausea, vomiting, diarrhea, epigastric pain, laboured respiration, convulsions and coma.
Treatment: No specific antidote. Induce emesis, gastric lavage, supportive treatment (intravenous glucose infusions).
",,,"Store between 15-30° C.
",12
+1020,Sulfasalazine,sulfasalazine-1020,https://medex.com.bd/attachments/ITqSprqttTSb4lJCMhYxmpaQlZ2YEb/sulfasalazine-prescribing-information,Drugs for Irritable Bowel Syndrome,Rheumatoid arthritis,"Sulfasalazine is indicated in:
+
+- Rheumatoid arthritis & Juvenile arthritis: In the treatment of patients with rheumatoid arthritis and pediatiric patients with polyarticular-course juvenile rheumatoid arthritis, who have responded inadequately to salicylates or other non-steroidal anti-inflammatory drugs (NSAIDs).
... Read more
Sulfasalazine is indicated in:
+
+- Rheumatoid arthritis & Juvenile arthritis: In the treatment of patients with rheumatoid arthritis and pediatiric patients with polyarticular-course juvenile rheumatoid arthritis, who have responded inadequately to salicylates or other non-steroidal anti-inflammatory drugs (NSAIDs).
+- Ulcerative colitis and Crohn's Disease: As adjunct in the treatment of ulcerative colitis with the usual supportive and dietary measures. In the treatment of active Crohn's disease, especially in patients with colonic involvement.
+
","Drugs for Irritable Bowel Syndrome, Drugs used for Rheumatoid Arthritis, Ulcerative Colitis
","The mode of action of Sulfasalazine is still under investigation, but may be related to the anti inflammatory and/or immunomodulatory properties that have been observed in animal and in vitro models, to its affinity for connective tissue, and/or to the relatively high concentration it reaches in serous fluids, the liver and intestinal walls, as demonstrated in autoradiographic studies in animals. In ulcerative colitis, clinical studies utilizing rectal administration of Sulfasalazine, Sulfapyridine and 5-Aminosalyclic Acid have indicated that the major therapeutic action may reside in the 5-Aminosalyclic Acid moiety. The relative contribution of the parent drug and the major metabolites in rheumatoid arthritis is unknown.
","The dosage of Sulfasalazine tablets should be individually adjusted according to the patient's tolerance and response to the treatment and taken in evenly divided doses preferably after meals.
Adult dose for crohn’s disease: 500 mg orally 2 to 4 times a day with food.
Pediatric use (6 years or older) for Ulcerative Colitis: The initial dose 40 to 60 mg/kg/day orally divided into 3 to 6 doses.
Adult dose for rheumatoid arthritis: 2 g daily in two evenly divided doses. It is advisable to initiate therapy with a lower dosage e.g. 0.5 to 1.0 g daily, to reduce possible gastrointestinal intolerance. A suggested dosing schedule is given bellow:
+
+- First week: One tablet in the evening
+- Second week: One tablet in the morning & One tablet in the evening
+- Third week: One tablet in the morning & two tablet in the evening
+- Fourth week: Two tablet in the morning & two tablet in the evening
+
+
In case of rheumatoid arthritis 6 years or older: initial dose 10 mg/kg/day orally in 2 equally divided doses.
Juvenile rheumatoid arthritis-polyarticular course: Children 6 years of age and older: 30 to 50 mg/kg/day in two evenly divided doses. Typically the maximum dose is 2 g per day.
For other indications:
Initial therapy:
+
+- Adults: 3 to 4 g daily in divided doses with dosage intervals not exceeding eight hours. It may be advisable to initiate therapy with a lower dosage e.g. 1 to 2 g daily to reduce possible gastrointestinal intolerance.
+- Children 6 years of age and older: 40 to 60 mg/kg/day in to 3 to 6 divided doses.
+
+Maintenance therapy:
+
+- Adults: 2 g daily.
+- Children 6 years of age and older: 30 mg/kg/day in 4 divided doses.
+
",,"Reduced absorption of folic acid and digoxin has been reported when those agents were administered concomitantly with sulfasalazine.
","Hypersensitivity to Sulfasalazine, its metabolites, sulfonamides or salicylates, patients with intestinal or urinary obstruction and porphyria.
","The common adverse reactions are anorexia, headache, nausea, vomiting, gastric distress, dyspepsia, abdominal pain, dizziness, apparently reversible oligospermia etc.
","Use in pregnancy: Pregnancy category B. This drug should be used during pregnancy only if clearly needed.
Use in lactation: Caution should be exercised when sulfasalazine is administered to a nursing mother.
","Hepatic/renal impairment, G6PD deficiency, allergic bronchial asthma, lactation.
",,,,,"Store in a cool and dry place, protected from light.
",10
+1023,Sulfacetamide sodium,sulfacetamide-sodium-1023,,Ophthalmic antibacterial drugs,Inflammatory conditions of the palpebral and bulbar conjunctiva,"Sulfacetamide sodium ophthalmic solution is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus ... Read more
Sulfacetamide sodium ophthalmic solution is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.
Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.
","Ophthalmic antibacterial drugs
","The sulfonamides are bacteriostatic agents and the spectrum of activity is similar for all. Sulfonamides inhibit bacterial synthesis of dihydrofolic acid by preventing the condensation of the pteridine with aminobenzoic acid through competitive inhibition of the enzyme dihydropteroate synthetase. Resistant strains have altered dihydropteroate synthetase with reduced affinity for sulfonamides or produce increased quantities of aminobenzoic acid.
Topically applied sulfonamides are considered active against susceptible strains of the following common bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.
Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.
","For conjunctivitis and other superficial ocular infections: Instill one or two drops into the conjunctival sac(s) of the affected eye(s) every two to three hours initially. Dosages may be tapered by increasing the time interval between doses as the condition responds. The usual duration of treatment is seven to ten days.
For trachoma: Instill two drops into the conjunctival sac(s) of the affected eye(s) every two hours. Topical administration must be accompanied by systemic administration.
",,"Sulfacetamide preparations are incompatible with silver preparations.
","Sulfacetamide sodium ophthalmic solution is contraindicated in individuals who have a hypersensitivity to sulfonamides or to any ingredient of the preparation.
","Bacterial and fungal corneal ulcers have developed during treatment with sulfonamide ophthalmic preparations. The most frequently reported reactions are local irritation, stinging and burning. Less commonly reported reactions include non-specific conjunctivitis, conjunctival hyperemia, secondary infections and allergic reactions.
Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias
","Pregnancy Category C. Animal reproduction studies have not been conducted with sulfonamide ophthalmic preparations. Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamides. There are no adequate and well controlled studies of sulfonamide ophthalmic preparations in pregnant women and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman. This product should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing mothers: Systemically administered sulfonamides are capable of producing kernicterus in infants of lactating women. Because of the potential for the development of kernicterus in neonates, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.
","Prolonged use of topical anti-bacterial agents may give rise to overgrowth of nonsusceptible organisms including fungi. Bacterial resistance to sulfonamides may also develop.
The effectiveness of sulfonamides may be reduced by the para-aminobenzoic acid present in purulent exudates.
Sensitization may recur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur.
At the first sign of hypersensitivity, increase in purulent discharge, or aggravation of inflammation or pain, the patient should discontinue use of the medication and consult a physician
","Pediatric use: Safety and effectiveness in infants below the age of two months have not been established.
",,,,"Store below 25° C.
",11
+1896,Sulconazole Nitrate,sulconazole-nitrate-1896,https://medex.com.bd/attachments/10GgIyiilS6RHyD5hgHv6tUgOsCoOu/sulconazole-nitrate-prescribing-information,,,"Sulconazole nitrate is a broad-spectrum antifungal agent indicated for the treatment of tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; and for the treatment of tinea versicolor. Effectiveness has not been proven ... Read more
Sulconazole nitrate is a broad-spectrum antifungal agent indicated for the treatment of tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; and for the treatment of tinea versicolor. Effectiveness has not been proven in tinea pedis (athlete's foot). Symptomatic relief usually occurs within a few days after starting Sulconazole nitrate and clinical improvement usually occurs within one week.
",,"Sulconazole nitrate is an imidazole derivative that inhibits the growth of the common pathogenic dermatophytes including Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis. It also inhibits the organism responsible for tinea versicolor, Malassezia furfur, and certain gram positive bacteria. A maximization test with sulconazole nitrate solution showed no evidence of irritation or contact sensitization.
","A small amount of the solution should be gently massaged into the affected and surrounding skin areas once or twice daily. Symptomatic relief usually occurs within a few days after starting Sulconazole nitrate, and clinical improvement usually occurs within one week. To reduce the possibility of recurrence, tinea cruris, tinea corporis, and tinea versicolor should be treated for 3 weeks. If significant clinical improvement is not seen after 4 weeks of treatment, an alternate diagnosis should be considered.
Pediatric Use: Safety and effectiveness in children have not been established.
Geriatric Use: Clinical studies of Sulconazole Nitrate, did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients.
",,,"Sulconazole nitrate is contraindicated in patients who have a history of hypersensitivity to any of the ingredients.
","There were no systemic effects and only infrequent cutaneous adverse reactions in 370 patients treated with sulconazole nitrate solution in controlled clinical trials. Approximately 1% of these patients reported itching and 1% burning or stinging. These complaints did not usually interfere with treatment.
","US FDA pregnancy category C. Animal studies have revealed evidence of embryotoxicity in rats at doses 125 times the human dose (in mg/kg); this dose given orally to rats led to prolonged gestation and dystocia, and several females died during the perinatal period (likely due to labor complications). Animal studies have failed to reveal evidence of teratogenicity in rats or rabbits at oral doses of 50 mg/kg/day. There are no controlled data in human pregnancy.
Excreted into human milk: Unknown. Excreted into animal milk: Data not available
","General: Sulconazole nitrate is for external use only. Avoid contact with the eyes. If irritation develops, the solution should be discontinued and appropriate therapy instituted.
Information for Patients: Patients should be told to use Sulconazole nitrate as directed by the physician, to use it externally only, and to avoid contact with the eyes.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies to determine carcinogenic potential have not been performed. In vitro studies have shown no mutagenic activity.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",8
+1633,Sucralose + Acesulfame Potassium,sucralose-acesulfame-potassium-1633,,Oral nutritional preparations,Artificial sweetener,"Tea, Coffee, fruit juices, baked foods, baking mixes, non alcoholic beverages, confections and frostings, fats and oils, frozen dairy desserts and mixes, sugar substitutes, sweet sauces, toppings and syrups.
","Oral nutritional preparations
","Suito is non-caloric sweetener. The majority of ingested Suito is not broken down by the body and therefore it is non-caloric. Sucralose & Acesulfame Potassium is 600 and 200 times as sweet as sucrose (table sugar) respectively. Sucralose is 3 times as sweet as Aspartame whereas Acesulfame Potassium is as sweet as Aspartame. Sucralose & Acesulfame Potassium are blended to give a more sugar-like taste whereby each sweetener masks the others aftertaste and exhibits a synergistic effect by which the blend is sweeter than its components. Suito is stable under heat and over a broad range of pH conditions.
",,,,,,,,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",4
+1046,Sucralose,sucralose-1046,,Oral nutritional preparations,Artificial sweetener,"Sucralose is a sugar substitute, can be used as sweetener in different foods like tea, coffee, pudding, milk products, jelly, fruit juices, desserts, hot and cold beverage etc. Due to zero calorie sweetener, it is a nice preparation for the health conscious people. Sucralose can be a unique choice for ... Read more
Sucralose is a sugar substitute, can be used as sweetener in different foods like tea, coffee, pudding, milk products, jelly, fruit juices, desserts, hot and cold beverage etc. Due to zero calorie sweetener, it is a nice preparation for the health conscious people. Sucralose can be a unique choice for the diabetic patients who have excess amount of glucose in blood. FDA has confirmed that sucralose is suitable for use by everyone, including children, pregnant women and any person who wants to reduce calorie intake.
","Oral nutritional preparations
","Sucralose is a Zero Calorie artificial sweetener. Sucralose is about 600 times sweeter than sugar. Sucralose Obtained from sucrose where three hydroxyl groups are replaced by three chlorine atoms. Because it is made from sugar, sucralose tastes like sugar. Tightly bound Carbon-chlorine bonds are exceptionally stable and prevent Sucralose from being metabolized for energy, making Sucralose calorie free. The chlorine atoms also provide heat stability, enabling sucralose to withstand of cooking and baking without losing sweetness. Sucralose is not broken down for energy in the body. So it has no calorie. The sucralose molecule passes through the body unchanged, is not metabolized and is eliminated after consumption. Sucralose does not cause tooth decay, has no effect on carbohydrate metabolism, no effect on fetal or neonatal development because sucralose is not actively transported across the blood-brain barrier, the placental barrier or the mammary gland. Sucralose is non-interference in the utilization and absorption of glucose, metabolism of carbohydrates and secretion of insulin. Therefore, it is a safe substance able to be ingested by diabetes patients.
","The acceptable daily intake of sucralose is 5-15 mg/kg body weight. Normally 1 tablet (8 mg) in a cup of tea or coffee is enough to sweeten the drink.
+
The acceptable daily intake (ADI) of Sucralose Sweet Drops is 5-15 mg per kg of body weight. Each drops sweetness is like one teaspoon of sugar. Normally one drop in a cup of tea or coffee is enough to sweeten the drink or as directed by the physician.
",,"There are no known drug interactions and none well documented.
","No known contraindication.
","No known side effects
","FDA has not yet classified the drug into a specified pregnancy category.
",,,,,,"Store at temperature not exceeding 30°C. Keep in a cool and dry place, protected from light. Keep out of reach of children.
",9
+1019,Sucralfate,sucralfate-1019,https://medex.com.bd/attachments/80ZvjnWhW08kBp3KqS0Mo7I8wmPf6h/sucralfate-oral-suspension-prescribing-information,Chelating complex,Peptic ulcer disease,"Sucralfate is indicated in adults and adolescents over 14 years old for treatment of-
+
+- Duodenal ulcer
+- Gastric ulcer
+- Chronic gastritis
+- The prophylaxis of gastrointestinal hemorrhage from stress ulceration in seriously ill patients.
+
","Chelating complex
","Sucralfate is non-systemic as the drug is only minimally absorbed from the gastrointestinal tract. The minute amount which absorbed primarily excretes in the urine. Sucralfate promotes the healing of gastric and duodenal ulcers by the formation of a chemical complex that binds to the ulcer site to establish a protective barrier. Besides, Sucralfate inhibits the action of pepsin and bile.
","Duodenal ulcer, gastric ulcer, chronic gastritis-
+
+- Adults: The usual dose is Sucralfate 2 gm twice daily to be taken on rising and at bedtime or Sucralfate 1 gm four times a day to be taken 1 hour before meals and at bedtime. Maximum daily dose is 8 gm but up to twelve weeks may be necessary in resistant cases.
+- Pediatric population: The safety and efficacy of Sucralfate in children under 14 years of age has not been established.
+- Elderly: There are no special dosage requirements for elderly patients but as with all medicines the lowest effective dose should be used.
+
+Prophylaxis of gastrointestinal hemorrhage from stress ulceration-
+
+- Adults: The usual dose is Sucralfate 1 gm orally or via a nasogastric tube 4 to 6 times a day. To prevent clogging of the nasogastric tube flush with 10 ml of water following each administration. The duration of treatment for prophylaxis of stress ulceration must be individually determined. Treatment should be continued for as long as one or more of the risk factors for stress ulceration is present but normally not for more than 14 days.
+
","Sucralfate should be taken on an empty stomach. Antacid should not be administered within 30 minutes of Sucralfate.
","Concomitant administration of Sucralfate may reduce the bioavailability of certain drugs including Fluoroquinolones such as Ciprofloxacin and Norfloxacin, Tetracycline, Ketoconazole, Sulpiride, Digoxin, Warfarin, Phenytoin, Theophylline, Levothyroxine, Quinidine, and H2 antagonists. The bioavailability of these agents may be restored by separating the administration of these agents from Sucralfate by two hours. This interaction appears to be non-systemic in origin presumably resulting from these agents being bound by Sucralfate in the gastrointestinal tract. Because of the potential of Sucralfate to alter the absorption of some drugs from the gastrointestinal tract, the separate administration of Sucralfate from that of other agents should be considered when alterations in bioavailability are felt to be critical for concomitantly administered drugs. Sucralfate should not be co-administered with citrate preparations. Co-administration citrate preparations with sucralfate may increase the blood concentrations of aluminium. The mechanism may be due to the chelation of aluminium which is assumed to increase its absorption. The administration of Sucralfate 1 g and enteral feeds by nasogastric tube should be separated by one hour in patients receiving Sucralfate 1 g for the prophylaxis of stress ulceration. In rare cases, bezoar formation has been reported when Sucralfate and enteral feeds have been given too closely together.
","Sucralfate tablet and suspension are contraindicated in patients with hypersensitivity to sucralfate.
","The most common adverse event was headache (3.4%) followed by nausea (2.3%), abdominal pain (2.3%), constipation (1.1%), diarrhea (1.1%), and urticaria (1.1%). The majority of patients who reported bezoars, had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings. Episodes of hyperglycemia have been reported in diabetic patient.
","Safety in pregnant women has not been established and Sucralfate should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Caution should be exercised when Sucralfate is administered to breast-feeding women.
","Sucralfate should only be used with caution in patients with renal dysfunction, due to the possibility of increased aluminium absorption. Sucralfate is not recommended for use in individuals on dialysis. In patients with severe or chronic renal impairment, Sucralfate should be used with extreme caution and only for short-term treatment. Small amounts of aluminium are absorbed through the gastrointestinal tract and aluminium may accumulate. Aluminium osteodystrophy, osteomalacia, encephalopathy and anaemia have been reported in patients with chronic renal impairment. For patients with impairment of renal function, laboratory testing such as aluminium, phosphate, calcium and alkaline phosphatase is recommended to be periodically performed due to excretion impairment. The concomitant use of other aluminium containing medications is not recommended in view of the enhanced potential for aluminium absorption and toxicity. Bezoars have been reported after administration of sucralfate mainly to severely ill patients in intensive care units. The majority of these patients (including neonates in whom sucralfate is not recommended) had underlying conditions that may predispose to bezoar formation (such as delayed gastric emptying due to surgery, drug therapy or diseases that reduce motility) or were receiving concomitant enteral tube feeding.
","Pediatric Population: Sucralfate is not recommended for use in children under 14 years of age due to insufficient data on safety and efficacy.
In elderly patients: Dose adjustments are not necessary.
Renal Impairment: Sucralfate should be used with caution in renal insufficiency patients.
Effects on ability to drive and use machines: Patients should not be drive if feel dizzy or drowsy.
","In a clinical trial on healthy men of overdose with Sucralfate, most cases remained asymptomatic but symptoms of abdominal pain, nausea, and vomiting were reported in a few cases. Acute oral toxicity studies in animals using doses up to 12 gm/kg body weight could not find a lethal dose. Risks associated with overdose should therefore be minimal.
",,,"Store in a cool and dry place, protected from light.
",13
+1018,Strontium Ranelate,strontium-ranelate-1018,https://medex.com.bd/attachments/TbscnCPkpXT4vu6mugTUrg5xPUkkec/strontium-ranelate-prescribing-information,Inhibiting bone resorption,Post-menopausal osteoporosis,"Strontium Ranelate is a non-hormonal medicine used to treat osteoporosis in postmenopausal women. Strontium Ranelate reduces the risk of fracture at the spine and at the hip
About osteoporosis: Your body is constantly breaking down old bone and making new bone tissue. If ... Read more
Strontium Ranelate is a non-hormonal medicine used to treat osteoporosis in postmenopausal women. Strontium Ranelate reduces the risk of fracture at the spine and at the hip
About osteoporosis: Your body is constantly breaking down old bone and making new bone tissue. If you have osteoporosis, your body breaks down more bone than it forms so that gradually bone loss occurs and your bones become thinner and fragile. This is especially common in women after the menopause (change of life). Many people with osteoporosis have no symptoms and you may not even know that you have it. However, osteoporosis makes you more likely to have fractures (break bones), especially in your spine, hips and wrists.
","Inhibiting bone resorption
","Strontium Ranelate works by reducing bone breakdown and stimulating rebuilding of bone and therefore reduces the risk of fracture. The newly formed bone is of normal quality.
","The recommended dose is one 2 gm sachet a day. Strontium should always be taken as per the advice of the doctor. Please check with your doctor in case of any confusion. Strontium is for oral use.
","It is recommended that you take Strontium at bedtime. You may lie down immediately after taking Strontium if you wish. Take the granules contained in the sachets as a suspension in a glass of water (see instructions below). Strontium can interact with milk and milk products, so it is important that you mix Strontium only with water to be sure it works properly
Drink straight away. If for some reason you do not drink the medicine straight away, make sure you stir it again before drinking. You should not leave it more than 24 hours before you drink it. Your doctor may advise you to take calcium and vitamin D supplements in addition to Strontium. Do not take calcium supplements at bedtime, at the same time as Strontium. Your doctor will tell you how long you should continue to take Strontium. Osteoporosis therapy is usually required for a long period. It is important that you continue taking Strontium
If you forget to take Strontium: Do not take a double dose to make up for forgotten individual doses. Just carry on with the next dose at the normal time.
","Taking other medicines: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you are taking medicines containing calcium, you should leave at least 2 hours before you take Strontium Ranelate . If you take antacids (medicines to relieve heartburn) you should take them at least 2 hours after Strontium Ranelate . If this is not possible, it is acceptable to take the two medicines at the same time. You should stop taking Strontium Ranelate if you have to take oral tetracyclines or quinolones (two types of antibiotics). You can take Strontium Ranelate again when you have finished taking these antibiotics. If you are unsure about this ask your doctor.
Taking Strontium Ranelate with food and drink: Food, milk and milk products reduce the absorption of strontium ranelate. It is recommended that you take Strontium Ranelate in-between meals, preferably at bedtime at least two hours after food, milk or milk products or calcium supplements.
","Strontium Ranelate is not intended for use in children and adolescents. During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), you must stop taking Strontium Ranelate and seek medical advice immediately. If you have stopped treatment due to hypersensitivity reactions you should not re-start therapy with Strontium Ranelate
","Like all medicines, Strontium can cause side effects, although not everybody gets them. The most common side effects are nausea, diarrhoea, headache and skin irritation. However,these effects were mild and short-lived and usually did not cause the patients to stop taking their treatment. Other events less commonly reported included blood clots, fainting fit, memory troubles and, in rare cases, seizures. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
","Pregnancy: Strontium Ranelate is meant for use only in postmenopausal women. Therefore, this should not be taken during pregnancy. If you take it by accident during pregnancy, stop taking it straight away and talk to your doctor.
Breast-feeding: Strontium Ranelate is meant for use only in postmenopausal women. Therefore, breast-feeding women should not take this medicine. If you take it by accident during breast- feeding, stop taking it straight away and talk to your doctor.
","Before taking Strontium Ranelate talk to your doctor:
+
+- if you have severe kidney disease.
+- if you are being treated or have been treated for blood clots.
+- if you are confined to bed or if you are to undergo an operation. The risk of vein thrombosis (blood clots in the leg) may be increased in the event of lengthy immobilization.
+- if you are allergic (hypersensitive) to strontium ranelate.
+
+Strontium Ranelate is not intended for use in children and adolescents. During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), you must stop taking Strontium Ranelate and seek medical advice immediately. If you have stopped treatment due to hypersensitivity reactions you should not re-start therapy with Strontium Ranelate.
",,"If you take too many sachets of Strontium Ranelate, tell your doctor. They may advise you to drink milk or take antacids to reduce the absorption of the active ingredient.
",,"
+- Empty the granules from the sachet into a glass
+- Add water
+- Stir until the granules are evenly dispersed in the water
+
","Keep out of the reach and sight of children. Store at a cool and dry place, away from light
",13
+1017,Streptomycin,streptomycin-1017,https://medex.com.bd/attachments/uQhu8Bq6QuOpd0uxqxs46YeEhu3DC4/streptomycin-prescribing-information,Aminoglycosides,Tuberculosis,"Streptomycin is indicated for the treatment of individuals with moderate to severe infections caused by susceptible strains of microorganisms in the specific conditions listed below:
Mycobacterium tuberculosis: The Advisory Council for the Elimination of Tuberculosis, the American Thoracic ... Read more
Streptomycin is indicated for the treatment of individuals with moderate to severe infections caused by susceptible strains of microorganisms in the specific conditions listed below:
Mycobacterium tuberculosis: The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and the Center for Disease Control recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin and pyrazinamide for initial treatment of tuberculosis unless the likelihood of INH or rifampin resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. In the past when the national rate of primary drug resistance to isoniazid was known to be less than 4% and was either stable or declining, therapy with two and three drug regimens was considered adequate. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered. Streptomycin is also indicated for therapy of tuberculosis when one or more of the above drugs is contraindicated because of toxicity or intolerance. The management of tuberculosis has become more complex as a consequence of increasing rates of drug resistance and concomitant HIV infection. Additional consultation from experts in the treatment of tuberculosis may be desirable in those settings.
Non-tuberculosis infections: The use of streptomycin should be limited to the treatment of infections caused by bacteria which have been shown to be susceptible to the antibacterial effects of streptomycin and which are not amenable to therapy with less potentially toxic agents.
+
+- Pasteurella pestis (plague)
+- Francisella tularensis (tularemia)
+- Brucella
+- Calymmatobacterium granulomatis (donovanosis, granuloma inguinale)
+- H. ducreyi (chancroid)
+- H. influenzae (in respiratory, endocardial, and meningeal infections - concomitantly with another antibacterial agent)
+- K. pneumoniae pneumonia (concomitantly with another antibacterial agent)
+- E.coli, Proteus, A. aerogenes, K. pneumoniae, and Enterococcus faecalis in urinary tract infections
+- Streptococcus viridans, Enterococcus faecalis (in endocardial infections - concomitantly with penicillin)
+- Gram-negative bacillary bacteremia (concomitantly with another antibacterial agent)
+
+To reduce the development of drug-resistant bacteria and maintain the effectiveness of streptomycin and other antibacterial drugs, streptomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy
","Aminoglycosides, Anti-Tubercular Antibiotics
","Aminoglycosides like Streptomycin ""irreversibly"" bind to specific 30S-subunit proteins and 16S rRNA. Specifically Streptomycin binds to four nucleotides of 16S rRNA and a single amino acid of protein S12. This interferes with decoding site in the vicinity of nucleotide 1400 in 16S rRNA of 30S subunit. This region interacts with the wobble base in the anticodon of tRNA. This leads to interference with the initiation complex, misreading of mRNA so incorrect amino acids are inserted into the polypeptide leading to nonfunctional or toxic peptides and the breakup of polysomes into nonfunctional monosomes.
","Tularaemia:
+
+- Adult: 1-2 g daily in divided doses for 7-14 days until the patient is afebrile for 5-7 days.
+- Child: 15 mg/kg bid for at least 10-14 days. Max: 2 g daily
+
+Bacterial endocarditis:
+
+- Adult: Streptococcal endocarditis: 1 g bid for 1 wk, then 500 mg bid for the 2nd wk. Enterococcal endocarditis: 1 g bid for 2 wk then 500 mg bid for an additional 4 wk. Doses are given in combination with penicillin.
+- Child: Enterococcal endocarditis: 20-30 mg/kg daily in 2 divided doses, in combination w/ penicillin.
+- Elderly: Streptococcal endocarditis: >60 yr 500 mg bid for the entire 2 wk period.
+
+Tuberculosis:
+
+- Adult: 15 mg/kg as a single dose daily. Max: 1 g daily. As part of intermittent regimen: 25-30 mg/kg 2-3 times wkly. Max: 1.5 g/dose.
+- Child: 20-40 mg/kg as a single dose daily. Max: 1 g daily. As part of intermittent regimen: 25-30 mg/kg 2-3 times wkly. Max: 1.5 g/dose.
+- Elderly: >40 yr Max: 500-750 mg daily.
+
+Plague:
+
+- Adult: 2 g daily in 2 divided doses for a minimum of 10 days.
+- Child: 30 mg/kg daily in 2-3 divided doses. Max: 2 g daily.
+
+Bacteraemia, Brucellosis, Meningitis, Pneumonia, Urinary tract infections:
+
+- Adult: For concomitant use with other agents and as 2nd line agent: 1-2 g daily in divided doses 6-12 hrly. Max: 2 g daily.
+- Child: 20-40 mg/kg daily in divided doses 6-12 hrly.
+
",,"Additive neurotoxic and nephrotoxic effect with neomycin, kanamycin, gentamicin, cefaloridine, paronomycin, viomycin, polymyxin B, colistin, tobramycin, and ciclosporin. Enhanced ototoxic and nephrotoxic effect with ethacrynic acid, mannitol, furosemide and possibly other diuretics. May enhance the resp depressant effect of neuromuscular blockers. Increased risk of nephrotoxicity with cephalosporins. Reduced excretion with NSAIDs.
","Hypersensitivity to streptomycin and other aminoglycosides.
","Neurotoxic reactions (e.g. vestibular and cochlear function disturbance, optic nerve dysfunction, peripheral neuritis, arachnoiditis, encephalopathy); paraesthesia of face, rash, fever, angioneurotic oedema, eosinophilia; exfoliative dermatitis, azotemia, leucopenia, thrombocytopenia, pancytopenia, haemolytic anaemia, muscular weakness, amblyopia.
","Streptomycin can cause fetal harm when administered to a pregnant woman. Because streptomycin readily crosses the placental barrier, caution in use of the drug is important to prevent ototoxicity in the fetus. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
","Patient with neuromuscular disorders (e.g. myasthenia gravis), pre-existing vertigo, or hearing loss. Renal impairment. Elderly, childn. Pregnancy and lactation.
","Renal Impairment: Dosage adjustment needed.
",,,"Add 4.2 mL, 3.2 mL, or 1.8 mL of sterile water for inj to prepare a soln containing approx 200 mg, 250 mg, or 400 mg, respectively, of streptomycin per mL.
","Store between 15-30°C. Protect from light.
",12
+1016,Streptokinase,streptokinase-1016,https://medex.com.bd/attachments/2QZ9A2khymECOPY18J2fbHrGJI0ZTp/streptokinase-prescribing-information,Fibrinolytics (Thrombolytics),Pulmonary thromboembolism,"Streptokinase is indicated for use in the management of acute myocardial infarction, for the lysis of intracoronary thrombi, for the improvement of ventricular function, and reduction of mortality when administered by either the intravenous or intracoronary route. Earlier administration of streptokinase ... Read more
Streptokinase is indicated for use in the management of acute myocardial infarction, for the lysis of intracoronary thrombi, for the improvement of ventricular function, and reduction of mortality when administered by either the intravenous or intracoronary route. Earlier administration of streptokinase is correlated with greater clinical benefit, the greatest benefit (in terms of mortality reduction) being seen when Streptase is administered within the first 4 hours after onset of symptoms. The treatment should always commence within 6 hours of the onset of pain.
","Fibrinolytics (Thrombolytics)
","Streptokinase forms a complex with plasminogen which then converts plasminogen to plasmin. Plasmin breaks down clots as well as fibrinogen and other plasma proteins.
","Streptokinase can be reconstituted using 5 ml sodium chloride injection or 5% Dextrose Injection directing the diluent at the side of the vacuum packed vial rather than into drug powder
+
Acute Myocardial Infarction:
+IV infusion:
+
+- Vial size (IU): 15,00,000
+- Total solution volume: 45 ml
+- Infusion rate: Infuse 45 ml within 60 mins
+
+Intracoronary infusion:
+
+- Vial size (IU): 2,50,000
+- Total solution volume: 125 ml
+- 20,000 IU bolus, Infusion rate: Loading dose of 10 ml
+- 2,000 IU/min. for 60 minutes, Infusion rate: 60 ml/hour
+
+
+
Pulmonary Embolism, Deep Vein Thrombosis, Arterial Thrombosis or Embolism:
+
+- 2,50,000 IU loading dose over 30 min, Vial size (IU): 15,00,000, Total solution volume 90 ml, Infusion rate: Infuse 30 ml/hour for 30 min
+- 1,00,000 IU/hour for maintenance dose, Infusion rate: Infuse 6 ml/hour
+
",,"There is an increased risk of haemorrhage in patients simultaneously or previously receiving anticoagulants (such as Heparin or Coumarin derivatives) or drugs which inhibit platelet formation or function (e.g., Platelet aggregation inhibitors, Dextrans, Phenylbutazone, Dipyridamole, Non-steroidal anti-inflammatory drugs). The effect of Heparin can be neutralized rapidly by administration of Protamine Sulphate. The Thrombin time (TT) should not be more than twice the normal control value before thrombolytic therapy is started. In the case of prior treatment with coumarin derivatives, the International Normalized Ratio (INR) must be less than 1.3 before starting Streptokinase infusion.
Combination of Streptokinase with Aspirin for treatment of Myocardial infarction: Study showed a significant benefit to patients treated with these two agents after acute myocardial infarction. Mortality (both short and longer term) was reduced in these patients to a greater extent than in those treated with either agent alone.
Unless contraindicated, the concomitant use of Acetylsalicylic acid (ASA, Aspirin), starting prior to Streptokinase infusion and continued for one month thereafter may be instituted at the discretion of the physician. The benefit of combination therapy should therefore be weighed against the risk of increased haemorrhage.
Anticoagulation treatment following Streptokinase: Following high dose (1.5 million IU), short term treatment with Streptokinase, for acute myocardial infarction, the use of subsequent anticoagulant treatment has not yet been shown to be of unequivocal benefit. Therefore, in this situation, the use of anticoagulants should be decided by the physician.
","As thrombolytic therapy increases the risk of bleeding, Streptokinase, administered either systemically or locally, is contraindicated in the following situations:
Existing or recent haemorrhage and haemorrhagic diathesis (with the exception of consumption coagulopathy) Potential for internal bleeding (e.g., peptic ulcer, ulcerative colitis, diverticulitis or visceral tumours) All forms of reduced blood coagulability, in particular spontaneous fibrinolysis and extensive clotting disorders.
Recent (within 2 months) cerebrovascular accident, recent (within 10 days) facial or head trauma, intracranial or intraspinal surgery, known intracranial neoplasm and all known neoplasms with risk of haemorrhage
Invasive operations, e.g., recent organ biopsy, invasive diagnostic procedure, recent implantation of a vessel prosthesis, long-term traumatic closed-chest massage or other recent surgery (until the 6th to 10th post operative day, depending on the severity of surgical intervention)
Arteriovenous malformation or aneurysm: Haemorrhagic diathesis including thrombocytopenia or pronounced hepatic or renal dysfunction
Severe uncontrolled hypertension (systolic BP > 200 mm Hg, diastolic BP > 100 mm Hg), or hypertensive retinal changes grades III/IV), hypertonic fundus
Severe liver or kidney damage: Simultaneous treatment with oral anticoagulants (International Normalized Ratio (INR) >1.3)
Endocarditis or pericarditis (Immediately after streptococcal infections which have produced a high antiStreptokinase titre (acute rheumatic fever, acute glomerulo-nephritis, etc.). More than 5 days and less than 12 months since previous Streptokinase therapy.
","The following adverse reactions are based on experience from clinical trials and on post marketing experience of Streptokinase.
General disorders:
+
+- Common: Headache and back pain, muscle pain (including myalgia), chills and/or fever as well as asthenia/malaise.
+
+Haemorrhage and bleeding:
+
+- Common: Haemorrhages at invaded or disturbed sites, including the injection site, and ecchymoses. Gastrointestinal or genitourinary bleedings (including aggravation of menstrual bleeding), epistaxis.
+- Uncommon: Intracranial haemorrhages with their complications and possible fatal outcome, retinal haemorrhages, severe haemorrhages (also with fatal outcome) including liver haemorrhages, retroperitoneal bleedings, splenic rupture. Blood transfusions are rarely required.
+
+Immune system disorders:
+
+- Very common: Development of antistreptokinase antibodies
+- Common: Allergic-anaphylactic reactions such as rash, flushing, itching, urticaria, angioneurotic oedema, minor breathing difficulty, periorbital swelling, bronchospasm or hypotension.
+
+Nervous system disorders:
+
+- Rare: Neurologic symptoms (e.g., dizziness, confusion, paralysis, hemiparesis, agitation or convulsion) in the context of cerebral haemorrhages or cardiovascular disorders with hypoperfusion of the brain.
+
+Cardiac complication and vascular disorders:
+
+- Very common: Hypotension, heart rate and rhythm disorders, angina pectoris.
+- Common: Recurrent ischaemia, heart failure, reinfarction, cardiogenic shock, pericarditis, pulmonary oedema.
+- Uncommon: Cardiac arrest (leading to respiratory arrest), mitral insufficiency, pericardial effusion, cardiac tamponade, myocardial rupture, pulmonary or distal embolism.
+
+Respiratory disorders:
+
+- Very rare: Non-cardiogenic pulmonary oedema after intracoronary thrombolytic therapy in patients with extensive myocardial infarction.
+
+Gastrointestinal disorders:
+
+- Common: Nausea, diarrhoea, epigastric pain and vomiting.
+
","Pregnancy category C. It is not known whether Streptokinase is excreted in the breast milk, nor whether it has harmful effects on the newborn. In the absence of further information, it is recommended that breast-feeding be discontinued in women who are to receive Streptokinase.
","Because of the increased likelihood of resistance, due to antistreptokinase antibodies, retreatment with Streptokinase or Streptokinase-containing products may not be effective if administered between five days and twelve months of prior Streptokinase administration or Streptococcal infections, such as Streptococcal pharyngitis, acute rheumatic fever or acute glomerulonephritis secondary to a Streptococcal infection.
In principle, no thrombolytic treatment should be commenced before the 10th postoperative day. However, in cases of pulmonary embolism, the indication for earlier treatment may be very strong and after careful consideration of all the risks, Streptokinase may be given before the tenth postoperative day. The danger of bleeding from the operative area must, of course, be taken into account.
The danger of haemorrhage is increased by simultaneous or previous treatment with anticoagulants (e.g., Heparin) or substances which inhibit platelet formation or function. If the patient is under active heparinisation, it should be neutralised by the administration of protamine sulphate before the start of thrombolytic therapy.
Repeated Administration: After administration of Streptokinase, the titre of antistreptokinase antibodies begins to rise after approximately one week, reaching a peak at 2 to 3 weeks and remains elevated for 8 to 12 months. Because of the increased likelihood of resistance, Streptokinase may not be effective if given during this period.
","Pediatric use: Safety & effectiveness in children have not been established.
","If uncontrollable bleeding occurs as a result of overdosage, Streptokinase infusion should be ceased immediately. Bleeding can be reversed and blood loss managed effectively with appropriate replacement therapy. Administration of aminocaproic acid or aprotinin may be useful.
",,"The protein nature and lyophilized form of Streptokinase, require careful reconstitution and dilution. The following reconstitution and dilution procedures are recommended for vials & infusion bottles:
+
+- Slowly add 5 mL Sodium Chloride Injection or 5% Dextrose Injection to the Streptokinase vial directing the diluent at the side of the vacuum-packed vial rather than into the drug powder.
+- Roll and tilt the vial gently to reconstitute. Avoid shaking. (Shaking may cause foaming.) (If necessary, total volume may be increased to a maximum of 50 mL in plastic containers and the infusion pump rate should be adjusted. To facilitate setting the infusion pump rate, a total volume of 45 mL, or a multiple thereof, is recommended.
+- Withdraw the entire reconstituted contents of the vial; slowly and carefully dilute further to a total volume as recommended. Avoid shaking and agitation on dilution.
+- When diluting the 1 500 000 IU infusion bottle (50 mL), slowly add 5 mL Sodium Chloride Injection or 5% Dextrose Injection, directing it at the side of the bottle rather than into the drug powder. Roll and tilt the bottle gently to reconstitute. Avoid shaking as it may cause foaming. Add an additional 40 mL of diluent to the bottle, avoiding shaking and agitation. (Total volume = 45 mL). Now administer by infusion pump.
+- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. (Human albumin may impart a slightly yellow color to the solution)
+- As Streptokinase contains no preservatives, it should be reconstituted immediately before use. The solution may be used for direct intravenous administration within eight hours following reconstitution if stored at 2-8° C
+- Do not add other medication to the container of Streptokinase.
+- Unused reconstituted drug should be discarded.
+
","Streptokinase vial should be stored at 2 to 25° C. Once reconstituted with physiological saline, the physico-chemical stability has been demonstrated for 24 hours at 2 to 8° C. From a microbiological point of view and as Streptokinase 1500000 contains no preservative, the reconstituted product should be used immediately. If it is not administered immediately, storage shall not exceed 24 hours at 2 to 8° C. Keep out of the reach of children.
",13
+1015,Spironolactone,spironolactone-1015,https://medex.com.bd/attachments/e1NgL3BgqEBIHC0TF5ZE8KnWXNWogB/spironolactone-prescribing-information,Potassium-sparing diuretics,Severe congestive heart failure,"Spironolactone is indicated in Congestive heart failure, Hepatic cirrhosis with ascites and oedema, Nephrotic syndrome, Primary hyperaldosteronism, Essential hypertension, For the treatment of patients with hypokalemia
","Potassium-sparing diuretics, Potassium-sparing diuretics & Aldosterone antagonists
","Spironolactone is a specific pharmacologic antagonist of aldosterone, acting primarily through competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tubule. Spironolactone causes increased amounts of sodium and water to be excreted, while potassium is retained. Spironolactone acts both as a diuretic and as an antihypertensive drug by this mechanism. It may be given alone or with other diuretic agents which act more proximally in the renal tubule. Aldosterone interacts with a cytoplasmic mineralocorticoid receptor to enhance the expression of the Na+ K+ ATPase and the Na+ channel involved in a Na+ K+ transport in the distal tubule . Spironolactone bind to this mineralcorticoid receptor, blocking the actions of aldosterone on gene expression. Aldosterone is a hormone; its primary function is to retain sodium and excrete potassium in the kidneys.
","Edema in adults (congestive heart failure, hepatic cirrhosis, or nephrotic syndrome): An initial daily dosage of 100 mg of Spironolactone administered in either single or divided doses is recommended, but may range from 25 to 200 mg daily. Combined therapy with other diuretics is indicated when more rapid diuresis is desired.
Primary hyperaldosteronism: After the diagnosis of hyperaldosteronism has been established, Spironolactone may be administered in doses of 100 to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, Spironolactone may be employed for long-term maintenance therapy at the lowest effective dosage determined for the individual patient.
Essential hypertension: For adults, an initial daily dosage of 50 to 100 mg of Spironolactone administered in either single or divided doses is recommended.
Hypokalemia: Spironolactone in a dosage ranging from 25 mg to 100 mg daily is useful in treating a diuretic-induced hypokalemia.
",,"ACE inhibitors: Concomitant administration of ACE inhibitors with potassium-sparing diuretics has been associated with severe hyperkalemia.
Alcohol, barbiturates, or narcotics: Potentiation of orthostatic hypotension may occur.
Corticosteroids, ACTH: Intensified electrolyte depletion, particularly hypokalemia, may occur.
Lithium: Lithium generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity.
Digoxin: Spironolactone has been shown to increase the half-life of digoxin.
","Spironolactone is contraindicated in patients with acute renal insufficiency, significant impairment of renal function, anuria, hyperkalaemia or sensitivity to Spironolactone.
","Gynaecomastia may develop in association with the use of Spironolactone. Other adverse reactions are: GI symptoms including cramping and diarrhoea, drowsiness, lethargy, headache, urticaria, mental confusion, impotence, irregular menses or amenorrhoea and post-menopausal bleeding.
","Pregnancy: Spironolactone should not be used during pregnancy
Lactation: Canrenone, an active metabolite of Spironolactone, appears in breast milk. If use of the drug is deemed essential an alternative method of infant feeding should be instituted.
","All patients receiving diuretic therapy should be observed for evidence of fluid or electrolyte imbalance. Hyperkalemia may occur in patients with impaired renal function or excessive potassium intake and can cause cardiac irregularities, which may be fatal.
",,"Symptoms of overdosage include drowsiness, mental confusion, dizziness, diarrhea and vomiting etc. Patients should induce vomiting or evacuate the stomach by lavage during Spironolactone overdoasge.
",,,"Store in a cool and dry place protected from light. Keep out of reach of children.
",11
+1014,Spiramycin,spiramycin-1014,https://medex.com.bd/attachments/BvbUjrboxPFPC5Qp1v0ts6qm6ZnfWd/spiramycin-prescribing-information,Macrolides,Toxoplasmosis,"Spiramycin is indicated for the treatment of infections of the respiratory tract, buccal cavity, skin and soft tissues due to susceptible organisms. Neisseria gonorrhoeae: as an alternate choice of treatment for gonorrhea in patients allergic to the penicillins. Before treatment of gonorrhea, the possibility of concomitant infection due to T. pallidum should be excluded.
","Macrolides
","The mechanism of action of macrolides has been a matter of controversy for some time. Spiramycin, a 16-membered macrolide, inhibits translocation by binding to bacterial 50S ribosomal subunits with an apparent 1 : 1 stoichiometry. This antibiotic is a potent inhibitor of the binding to the ribosome of both donor and acceptor substrates. The primary mechanism of action is done by stimulation of dissociation of peptidyl-tRNA from ribosomes during translocation.
","Adult: 6 to 9 Million International Units per 24 hours, in 2 divided doses. In severe infections, the daily dosage may be increased to 12 to 15 Million International Units per day. Gonorrhea: 12 to 13.5 Million International Units in a single dose.
Children: The usual daily dosage is based on 150,000 l.U./kg body weight in 2 or 3 divided doses.
","Spiramycin is stable in gastric juices and absorption is not affected by food. In severe infections, the daily dosage may be increased by one half. In the treatment of beta hemolytic streptococcal infections, adequate Spiramycin dosage should be administered for 10 days.
","Rovamycine has been reported to inhibit the absorption of carbidopa and decrease levodopa plasma levels. When necessary, patients should be closely monitored and the levodopa dosage levels adjusted.
","Spiramycin is contraindicated in patients with known hypersensitivity to the drug. The levels of spiramycin attained in the cerebrospinal fluid are much lower than those in the blood and are too low to be clinically useful. Therefore Spiramycin must not be used in patients with meningitis.
","Side effects of include: nausea, vomiting, diarrhea, inflamed bowels, pruritus (itchy skin), tingling or numbness in the skin.
","Safety of this product for use during pregnancy has not been established.
","Administer antibiotics, including Spiramycin cautiously to any patient who has demonstrated some form of allergy, particularly to drugs. The possibility of superinfection caused by overgrowth of nonsusceptible organisms should be kept in mind during prolonged or repeated therapy. If superinfection occurs, discontinue the drug and take appropriate measures.
",,"No case of accidental overdosage has been reported. In oral doses over 4 gm per day, abdominal discomfort, nausea or diarrhea may occur. No specific treatment has been proposed. Management should be symptomatic
",,,"Store in a dry place between 15ºC and 30ºC.
",12
+1013,Spectinomycin,spectinomycin-1013,https://medex.com.bd/attachments/vZdTooFcdPjXZHijgFenYUG82MhdTO/spectinomycin-prescribing-information,Macrolides,Urethritis,"Spectinomycin Sterile Powder is indicated in the treatment of:
+
+- Acute gonorrheal urethritis and proctitis in the male
+- Acute gonorrheal cervicitis and proctitis in the female
+- Men and women with known recent exposure to gonorrhea should be treated as those known to have gonorrhea.
+
","Macrolides
","Tinobac Sterile Powder contains Spectinomycin Hydrochloride which is an aminocyclitol antibiotic produced by a species of soil microorganism designated as Streptomyces spectabilis. Spectinomycin Hydrochloride is an inhibitor of protein synthesis in the bacterial cell; the site of action is the 30S ribosomal subunit. In vitro studies have shown Spectinomycin Hydrochloride to be active against most strains of Neisseria gonorrhoeae
","Adults (Men and Women): Inject 5 ml intramuscularly for a 2 gm dose.This is also the recommended dose for patients being treated after failure of previous antibiotic therapy.
Intramuscular injections should be made deep into the upper outer quadrant of the gluteal muscle.
Pediatric Use: Safety and effectiveness in the pediatric population have not been established.
",,,,"The following reactions were observed during the single dose clinical trials: soreness at the injection site, urticaria, dizziness, nausea, chills, fever and insomnia
","Pregnancy Category B. Since there are no controlled studies of Spectinomycin in pregnant women, and because animal reproduction studies are not always predictive of human responses, Spectinomycin should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Spectinomycin is administered to a nursing woman.
","The usual precautions should be observed with atopic individuals. Prescribing Spectinomycin Sterile Powder in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
",,"Information on overdosage in humans is not available. Hemodialysis has been reported to aid in the removal of intravenously administered Spectinomycin from the body.
",,"Spectinomycin 2 grams Sterile Powder: reconstitute with 3.2 ml of the accompanying water for injection with 0.9% Benzyl alcohol. Shake vials vigorously immediately after adding diluent and before withdrawing dose.
","Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+1012,Sparfloxacin,sparfloxacin-1012,https://medex.com.bd/attachments/NwnAzoAE4RPqwGRRDGRRPYHtxBRbvk/sparfloxacin-prescribing-information,4-Quinolone preparations,Upper and lower respiratory tract infections,"Sparfloxacin is indicated for the treatment of the following infections due to susceptible microorganisms:
+
+- Upper and lower respiratory tract infections including sinusitis, acute exacerbation of chronic bronchitis, community and hospital acquired pneumonia.
+- Urinary tract infections including gonococcal and non-gonococcal urethritis, chancroid and other sexually transmitted diseases.
... Read more
Sparfloxacin is indicated for the treatment of the following infections due to susceptible microorganisms:
+
+- Upper and lower respiratory tract infections including sinusitis, acute exacerbation of chronic bronchitis, community and hospital acquired pneumonia.
+- Urinary tract infections including gonococcal and non-gonococcal urethritis, chancroid and other sexually transmitted diseases.
+- Skin and soft tissue infections.
+- Prophylactic use in different urological and ophthalmic operations.
+
","4-Quinolone preparations
","Sparfloxacin is a synthetic, broad-spectrum antibacterial agent from the difluoroquinolone family. It has been reported to be more active in vitro than ciprofloxacin against some organisms, including staphylococci and Mycobacteria, and has a much longer plasma half-life (16 hours).
Sparfloxacin inhibits the supercoiling activity of DNA gyrase which is an enzyme essential for DNA replication thus promoting the breakage of DNA structures. It has activity against S. pneumoniae, S. aureus, H. influenzae, K. pneumoniae, M. catarrhalis and Mycobacterium spp.
","In patients with normal renal function the recommended daily dose is two tablets of Sparfloxacin 200 mg on first day as a loading dose, thereafter take one tablet of Sparfloxacin 200 mg every 24 hours for a total of 10 days of therapy.
The recommended daily dose of Sparfloxacin in patients with renal impairment (Creatinine clearance < 30 ml/min) is two tablets of 200 mg taken on the first day as a loading dose. Thereafter, should be taken one tablet of 200 mg every 48 hours for total of 9 days of therapy.
","Sparfloxacin can be taken with or without food.
","On concomitant use with Quinidine, Sotalol, Erythromycin, Astemizole, Terfenadine, vinca alkaloids there is increased risk of arrhythmia. Salts, oxides and hydroxides of Magnesium, Aluminium and Calcium decrease absorption of Sparfloxacin.
","Sparfloxacin is contraindicated for individuals with a history of hypersensifivity and in achilles tend in its following the use of fluoroquinolone and in pregnancy and lactation. Sparfloxacin is contraindicated in patients with known QTc prolongation or in patients being treated concomitantly with medications known to produce an increase in the QTc interval and/or torsade depointes.
","Most of the adverse events were mild to moderate in severity and transient in nature. The most frequently reported events among the Sparfloxacin treated patients with the recommended dosage are: diarrhea, nausea, headache, dyspepsia, dizziness, insomnia, abdominal pain and QTc interval prolongation.
","There are no adequate and well controlled studies in pregnant women. Sparfloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
","It should be used with caution in renal diseases, gastric ulcers and with concomitant use of NSAIDs. In renal failure of third degree severity (creatinine clearance < 30 ml/min) dosage modification is recommended 400 mg on 1st day, 200 mg on 2nd and 3rd day followed by 200 mg every 48 hours. Because fluoroquinolones have been associated with tendon rupture, Sparfloxacin should be discontinued at the first sign of tendon pain. Exposure to UV radiation during treatment should be avoided.
","Use in children: Safety and effectiveness have not been established in patients below the age of 18 years.
",,,,"Store at temperature below 30° C.
",12
+1011,Sotalol Hydrochloride,sotalol-hydrochloride-1011,https://medex.com.bd/attachments/NoCVLROB5ZxML9BMLrTuSgNo83vYrZ/sotalol-hydrochloride-prescribing-information,Anti adrenergic agent (Beta blockers),Supraventricular and ventricular arrhythmias,"Treatment of life-threatening arrhythmias including ventricular tachyarrhythmias, symptomatic non-sustained ventricular tachyarrhythmias. Prophylaxis of paroxysmal atrial tachycardia or fibrillation, paroxysmal AV re-entrant tachycardias (both nodal and involving accessory pathways), paroxysmal supraventricular ... Read more
Treatment of life-threatening arrhythmias including ventricular tachyarrhythmias, symptomatic non-sustained ventricular tachyarrhythmias. Prophylaxis of paroxysmal atrial tachycardia or fibrillation, paroxysmal AV re-entrant tachycardias (both nodal and involving accessory pathways), paroxysmal supraventricular tachycardia after cardiac surgery, maintenance of sinus rhythm following cardioversion of atrial fibrillation or flutter.
","Anti adrenergic agent (Beta blockers)
","Sotalol is a non-cardioselective beta-blocker. It increases sinus cycle length, slows heart rate, decreases AV nodal conduction and increases AV nodal refractoriness. It also prolongs AV monophasic action potentials. However, it lacks intrinsic sympathomimetic and membrane-stabilising properties.
","Initially 80 mg daily in 1-2 divided doses. After ECG monitoring and measurement of corrected QT interval, arrhythmias, dose is increased gradually at intervals of 2- 3 days to usual dose of 160-320 mg daily in 2 divided doses; higher doses of 480-640 mg daily for life-threatening ventricular arrhythmias under specialist supervision.
The dosage should be reduced in renal impairment. lf creatinine clearance is >60 ml/min, recommended dose 160 mg twice daily while in those with creatinine clearance between 40 and 60 ml/ min, the dose is administered once daily. ln patients with creatnine clearance less than 40 ml/min, Sotalol is contraindicated.
",,"ln combined therapy, clonidine should not be discontinued unitil several days after withdrawal of Sotalol. Use with great caution with drugs that also prolong OT interval, e.g. disopyramide, amiodarone, Class I antiarrhythmic agents, calcium antagonists of the verapamil type or tricyclic antidepressants. Interactions also occur with phenothiazines, terfenadine, astemizole and diltiazem. Concomitant use of reserpine, guanethidine, or alpha methyldopa requires close monitoring for evidence of hypotension and/or marked bradycardia, syncope. Hypoglycemia may occur and the dosage of insulin or antidiabetic drugs may require adjustment.
","Sotalol should not be given to patients with sinus, bradycardia, sick sinus syndrome or second or third degree AV block (unless a functional pacemaker is present); congenital or acquired long QT syndromes, torsades de pointes, uncontrolled congestive heart failure, cardiogenic shock; anaesthesia that produces myocardial depression, hypotension (except due to arrhythmia), severe peripheral circulatory disturbances, chronic obstructive airway disease or bronchial asthma, renal failure (ceratinine clearance <40mL/min) and previous evidence of hypersensitivity to Sotalol. Sotalol should not be given to patients suffering from diabetic keto-acidosis or metabolic acidosis, therapy with Sotalol can be recommenced or resumed when the metabolic condition has been corrected.
","The most significant adverse effects are those which are typical of its class I and class II (Cardiac action potential duration prolongation) effects.
","Its use throughout pregnancy should be avoided unless it is absolutely necessary as it crosses the placenta and may cause foetal bardycardia. Infants should not be fed with breast milk from mothers being treated with Sotalol
","Sotalol is not for everyone with irregular heartbeats (atrial fibrillation). Sotalol is not indicated for those patients who have serious kidney problems or are on kidney dialysis, lung disease causing shortness of breath (such as asthma, chronic bronchitis or emphysema), symptoms of heart failure (such as shortness of breath when in exercise or physically active and swelling of the ankles or legs), very slow heart beat and do not have an implanted artificial pacemaker.
",,"Overdosage causes excessive bradycardia and hypotension; congestive heart failure, bronchospasm and hypoglycemia.
",,,"Store in a cool and dry place, protected from light.
",11
+1010,Sorafenib Tosylate,sorafenib-tosylate-1010,https://medex.com.bd/attachments/fFNxA4EhgVv97E5zrQjH9QNBmJ98Cn/sorafenib-tosylate-prescribing-information,Targeted Cancer Therapy,Renal cell carcinoma,"Hepatocellular Carcinoma: Sorafenib is indicated for the treatment of patients with unresectablehepatocellular carcinoma (HCC).
Renal Cell Carcinoma: Sorafenib is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).
","Targeted Cancer Therapy
","Sorafenib is a kinase inhibitor that decreases tumor cell proliferation in vitro. Sorafenib was shown to inhibit multiple intracellular (CRAF, BRAF and mutant BRAF) and cell surface kinases (KIT, FLT-3, RET, VEGFR-1, VEGFR-2, VEGFR-3, and PDGFR-ß). Several of these kinases are thought to be involved in tumor cell signaling, angiogenesis, and apoptosis. Sorafenib inhibited tumor growth and angiogenesis of human hepatocellular carcinoma and renal cell carcinoma, and several other human tumor xenografts in immunocompromised mice.
","Advanced renal cell carcinoma: 400 mg bid. May continue until patient is no longer responding or unacceptable toxicity occurs.
Hepatic Impairment: No safety data is available for use in patients with Child-Pugh C hepatic impairment.
","Should be taken on an empty stomach. May be taken with a low or moderate fat meal. If the patient intends to have a high fat meal, sorafenib should be taken on an empty stomach at least 1 hr before or 2 hr after meals. Swallow whole, do not chew/crush.
","Inducers of isoenzyme CYP3A4 e.g. carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampicin may decrease sorafenib plasma concentration. Coadmin with sorafenib may increase the plasma concentration of doxorubicin and irinotecan.
","Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of Sorafenib. Sorafenib in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer
","Rash and hand-foot skin reactions. Hypophosphataemia, hypertension, bleeding, tinnitus, depression and erectile dysfunction. Alopecia, pruritus, dry skin, erythema, acne, flushing, exfoliative dermatitis, hoarseness, GI disturbances, arthralgia, myalgia, asthenia, pain and peripheral neuropathy.
","Pregnancy category D There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Interrupt teatment if patient develops cardiac infarction, ischaemia and/or bleeding fatalities. Regular monitoring of BP, CBC and platelet is recommended. Monitor INR in patients who are on treatment with warfarin. Adequate contraception should be used during and for at least 2 wk after stopping treatment. May need to discontinue treatment if severe or persistent hypertension occurs.
",,"There is no specific treatment for Sorafenib overdose. The highest dose of Sorafenib studied clinically is 800 mg twice daily. The adverse reactions observed at this dose were primarily diarrhea and dermatologic. No information is available on symptoms of acute overdose in animals because of the saturation of absorption in oral acute toxicity studies conducted in animals. In cases of suspected overdose, Sorafenib should be withheld and supportive care instituted.
",,,"Store at 25° C.
",12
+1009,Somatropin,somatropin-1009,https://medex.com.bd/attachments/yAc25e88z4mR8ssofZiD0IlpscqOrB/somatropin-prescribing-information,Drugs for Growth failure,Growth hormone deficiency,"Pediatric Patients:
+
+- Somatropin injection is indicated for the treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH).
+- Somatropin injection is indicated for the treatment of pediatric patients with short stature associated with Noonan syndrome.
... Read more
Pediatric Patients:
+
+- Somatropin injection is indicated for the treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH).
+- Somatropin injection is indicated for the treatment of pediatric patients with short stature associated with Noonan syndrome.
+- Somatropin injection is indicated for the treatment of pediatric patients with short stature associated with Turner syndrome.
+- Somatropin injection is indicated for the treatment of pediatric patients with short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years.
+
+Adult Patients: Somatropin injection is indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD) who meet either of the following two criteria:
+
+- Adult Onset (AO): Patients who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
+- Childhood-Onset (CO): Patients who were GH deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.
+
+Patients who were treated with somatropin for GHD in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for GHD adults. According to current standards, confirmation of the diagnosis of adult GHD in both groups involves an appropriate growth hormone provocative test with two exceptions: (1) patients with multiple other pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic growth hormone deficiency.
","Drugs for Growth failure
","Somatropin (as well as endogenous GH) binds to a dimeric GH receptor in the cell membrane of target cells resulting in intracellular signal transduction and a host of pharmacodynamic effects. Some of these pharmacodynamic effects are primarily mediated by IGF-I produced in the liver and also locally (e.g., skeletal growth, protein synthesis), while others are primarily a consequence of the direct effects of somatropin (e.g., lipolysis).
","Somatropin should be administered subcutaneously. Injection sites should always be rotated to avoid lipoatrophy.
+
+- Pediatric growth hormone deficiency: 0.024 to 0.034 mg/kg/day, 6 to 7 times a week.
+- Noonan Syndrome: Up to 0.066 mg/kg/day.
+- Turner Syndrome: Up to 0.067 mg/kg/day.
+- Short stature born small for gestational age (SGA): Up to 0.067 mg/kg/day.
+- Adult growth hormone deficiency: 0.004 mg/kg/day to be increased as tolerated to not more than 0.016 mg/kg/day after approximately 6 weeks, or a starting dose of approximately 0.2 mg/day (range, 0.15 to 0.30 mg/day) increased gradually every 1 to 2 months by increments of approximately 0.1 to 0.2 mg/day.
+
",,"
+- Inhibition of 11ß-Hydroxysteroid Dehydrogenase Type 1: May require the initiation of glucocorticoid replacement therapy. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance doses.
+- Glucocorticoid Replacement: Should be carefully adjusted.
+- Cytochrome P450-Metabolized Drugs: Monitor carefully if used with somatropin.
+- Oral Estrogen: Larger doses of somatropin may be required in women.
+- Insulin and/or Oral/Injectable Hypoglycemic Agents: May require adjustment.
+
","
+- Acute Critical Illness
+- Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment-reports of sudden death
+- Active Malignancy
+- Hypersensitivity to somatropin or excipients
+- Active Proliferative or Severe Non-Proliferative Diabetic Retinopathy
+- Children with closed epiphyses
+
","The most common side effects of Somatropin include headaches, muscle pain, joint stiffness, high blood sugar (hyperglycemia), sugar in your urine (glucosuria).
","Pregnancy Category C. Animal reproduction studies have not been conducted with Somatropin. It is not known whether Somatropin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Somatropin should be given to a pregnant woman only if clearly needed. It is not known whether Somatropin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Somatropin is administered to a nursing woman.
","Acute Critical Illness: Potential benefit of treatment continuation should be weighed against the potential risk
Prader-Willi Syndrome in Children: Evaluate for signs of upper airway obstruction and sleep apnea before initiation of treatment for GHD. Discontinue treatment if these signs occur.
Neoplasm: Monitor patients with preexisting tumors for progression or recurrence. Increased risk of a second neoplasm in childhood cancer survivors treated with somatropin- in particular meningiomas in patients treated with radiation to the head for their first neoplasm.
Impaired Glucose Tolerance and Diabetes Mellitus: May be unmasked. Periodically monitor glucose levels in all patients. Doses of concurrent antihyperglycemic drugs in diabetics may require adjustment.
Intracranial Hypertension: Exclude preexisting papilledema. May develop and is usually reversible after discontinuation or dose reduction.
Hypersensitivity: Serious hypersensitivity reactions may occur. In the event of an allergic reaction, seek prompt medical attention.
Fluid Retention (i.e., edema, arthralgia, carpal tunnel syndrome- especially in adults): May occur frequently. Reduce dose as necessary.
Hypoadrenalism: Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism.
Hypothyroidism: May first become evident or worsen.
Slipped Capital Femoral Epiphysis: May develop. Evaluate children with the onset of a limp or hip/knee pain.
Progression of Preexisting Scoliosis: May develop.
Pancreatitis: Consider pancreatitis in patients with persistent severe abdominal pain.
",,,,,"Store at 2-8°C. Do not freeze. Avoid direct light. Keep out of reach of children.
",10
+1395,Tedizolid Phosphate,tedizolid-phosphate-1395,https://medex.com.bd/attachments/SYRvmHn7BOngwf0pEHvT1NfVlhvCST/tedizolid-phosphate-prescribing-information,,Complicated skin and skin structure infections,"Tedizolid is an oxazolidinone-class antibacterial drug indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tedizolid ... Read more
Tedizolid is an oxazolidinone-class antibacterial drug indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tedizolid and other antibacterial drugs, Tedizolid should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria
","Other antibiotic
","After conversion to its active form by phosphatases, tedizolid exerts its antibacterial activity through inhibition of protein synthesis by binding to the 50S ribosomal subunit of susceptible Gram-positive bacteria. Cross-resistance between other non-oxazolidinone antibacterial drugs is unlikely as it inhibits bacterial protein synthesis through a different mechanism.
","Acute Bacterial Skin and Skin Structure Infection (ABSSSI):
+
+- Intravenous: 200 mg Once daily 1 hour (Infusion Time) for 6 days
+- Oral: 200 mg Once daily for 6 days
+
+No dose adjustment is necessary when changing from intravenous to oral Tedizolid. If patients miss a dose, they should take it as soon as possible anytime up to 8 hours prior to their next scheduled dose. If less than 8 hours remain before the next dose, wait until their next scheduled dose.
",,"Tedizolid (when administered orally) can increase the plasma concentrations of orally administered Breast Cancer Resistance Protein BCRP substrates. Monitor for adverse reactions related to the concomitant BCRP substrates if coadministration cannot be avoided
","None
","The most common adverse reactions (>2%) are nausea, headache, diarrhea, vomiting, and dizziness
","Pregnancy category C. There are no adequate and well-controlled studies of Tedizolid in pregnant women. Tedizolid should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: Tedizolid is excreted in the breast milk of rats. It is not known whether tedizolid is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tedizolid is administered to a nursing woman.
","Patients with neutropenia: The safety and efficacy of Tedizolid in patients with neutropenia (neutrophil counts <1000 cells/mm3) have not been adequately evaluated. In an animal model of infection, the antibacterial activity of Tedizolid was reduced in the absence of granulocytes. Consider alternative therapies in neutropenic patients.
Clostridium difficile-associated diarrhea: Evaluate if diarrhea occurs.
","Pediatric Use: Safety and effectiveness in pediatric patients below the age of 18 have not been established.
Geriatric Use: Clinical studies of Tedizolid did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. No overall differences in pharmacokinetics were observed between elderly subjects and younger subjects
","In the event of overdosage, Tedizolid should be discontinued and general supportive treatment given. Hemodialysis does not result in meaningful removal of tedizolid from systemic circulation
",,,"Tablets and injection should be stored at 20°C to 25°C
",12
+1830,Tea Tree Oil + Geothermal Water + Vitamin E,tea-tree-oil-geothermal-water-vitamin-e-1830,,Miscellaneous topical agents,Acne vulgaris,"This gel is indicated in-
+
+- Deeply clean acne-prone skin
+- Excessive sebum control
+- Acne Vulgaris
+- Dark Spot
+
","Miscellaneous topical agents
",,"Twice a day in the morning and evening.
",,,"Contraindicated in any other ingredient of this preparations.
",,,,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",5
+1624,Tea tree oil + Geothermal water (hair & body),tea-tree-oil-geothermal-water-hair-body-1624,https://medex.com.bd/attachments/3keYOuI2UwW9zRim8hiKW6mlACyUCN/tea-tree-oil-geothermal-water-hair-body-prescribing-information,Miscellaneous topical agents,Dry eye,"This shampoo is indicated in-
+
+- Dandruff
+- Pityriasis versicolor
+- Seborrhoeic dermatitis
+- Wide spread of bodily fungal acne & bacterial disease.
+
","Miscellaneous topical agents
","Tea Tree Oil: Tea tree oil comes from the leaves of Melaleuca alternifolia, a small tree native to Queensland and New South Wales, Australia. Tea tree oil contains a number of compounds, including terpinen-4-ol that have been shown to kill certain bacteria, viruses and fungi.
Geothermal Water: It is natural hot water and has skin healing benefits.
","Seborrheic Dermatitis: Apply in the hair thrice in a weekend wash properly after 5 minutes.
Bodily Fungal Infection (Eczema, Acne, Bedsores, aging): Apply in infected or lesion area once daily and wash after 5 minutes.
","
+- Use a small amount of water to wet the scalp
+- Apply the shampoo & massage gently until it forms a lather
+- Leave the shampoo on the scalp for 5 minutes
+- Rinse the shampoo with sufficient amount of water
+
",,,"Topical treatment with Tea Tree Oil (TTO) enriched with geothermal water is generally well tolerated. As with other shampoos, a local burning sensation, itching or contact dermatitis (due to irritation or allergy) may occur on exposed areas. Oily and dry hair have been reported rarely with the use of Tea Tree Oil (TTO) enriched with geothermal water.
","Since Tea Tree Oil (TTO) enriched with geothermal water shampoo is not absorbed through the skin after topical application, pregnancy and lactation are not a contraindication for the use of Tea Tree Oil (TTO) enriched with geothermal water shampoo.
",,,,,,"Keep out of reach of children, Store in a dry place, below 25°C temperature and protected from light.
",8
+1783,Tea tree oil + Geothermal water (eye),tea-tree-oil-geothermal-water-eye-1783,,Other preparations,Eye health,"ইহা নিম্নোক্ত উপসর্গে নির্দেশিত-
+
+- চোখের সুরক্ষায়
+- চোখ দিয়ে করোনা সংক্রামন প্রতরোধে
+- হাত জীবাণুমুক্ত করতে
+- চোখের পাতা ও ভ্রূ-এর খুশকী দূরীকরণে
+- চোখের শুস্কভাব দূর করতে
+- বলিরেখা প্রতিরোধে
+- কসমেটিকস পরিস্কার করতে।
+
","Other preparations
",,"সানগ্লাস বা গগলস ব্যবহারের পাশাপাশি রোগজীবানু প্রতিরোধী Tea tree oil ও Geothermal water সমৃদ্ধ Shampoo দিয়ে প্রতিদিন দুইবার করে চোখ পরিস্কার করলে চোখ দিয়ে করোনা ভাইরাসে সংক্রামিত হওয়ার সুযোগ কমে যায় এবং চোখের স্বাস্থ্যও সুরক্ষিত থাকে।
",,,,,,,,,,,"Keep out of reach of children, Store in a dry place, below 25°C temperature and protected from light.
",4
+1668,Tea tree oil + Echinacea + Geothermal water,tea-tree-oil-echinacea-geothermal-water-1668,,Oral preparations,Oral hygiene,"This is indicated in bad breath, prevents common cold and flu, kills virus, bacteria & fungus from oral cavity, gum protection, plaque control, enamel protection & to maintain oral hygiene.
","Oral preparations
",,"1-2 sprays into the mouth in the morning and evening. To be dispensed only by or on the prescription of a registered physician.
",,,"Hypersensitivity of any other ingredient of this preparation.
",,,,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",5
+1034,Tazarotene,tazarotene-1034,https://medex.com.bd/attachments/DgKXTLNHrhwzVEy8xBLvq7pWw4VgC6/tazarotene-prescribing-information,Topical retinoid and related preparations,Stable plaque psoriasis,"Tazarotene is used to treat plaque psoriasis of the skin. It also works to treat acne on the face.
","Topical retinoid and related preparations
","Tazarotene is a retinoid prodrug which is converted to its active form, the cognate carboxylic acid of tazarotene, by rapid deesterification in animals and man. In cell culture and in vitro models of skin, tazarotene suppresses expression of MRP8, a marker of inflammation present in the epidermis of psoriasis patients at high levels. In human keratinocyte cultures, it inhibits cornified envelope formation, whose build-up is an element of the psoriatic scale.
","For psoriasis: Tazarotene cream should be applied once per day, in the evening, to psoriatic lesions, using enough (2 mg/cm2) to cover only the lesion with a thin film. If a bath or shower is taken prior to application, the skin should be dried before applying the cream. If emollients are used, they should be applied at least one hour before application of Tazarotene cream.
For acne: Cleanse the face gently. After the skin is dry, apply a thin layer (2mg/cm2) of Tazarotene cream 0.1% once per day, in the evening, to the skin areas where acne lesions appear. Use enough to cover the entire affected area.
",,"Concomitant dermatologic medications and cosmetics that have a strong drying effect should be avoided. It is also advisable to ""rest"" a patient’s skin until the effects of such preparations subside before use of Tazarotene cream is begun. Topical steroid may be hazardous in psoriasis; careful patient supervision is important. Consider if infection spreads. Do not use near a naked flame.
","Retinoids may cause fetal harm when administered to a pregnant woman. Tazarotene cream is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be warned to the potential risk and use adequate birth-control measures when Tazarotene cream is used.
","The most frequent adverse events reported with Tazarotene cream were limited to the skin. Those occurring in 10 to 23% of patients, in descending order, included pruritus, erythema and burning. For acne treatment, in 10 to 30% patients, it is reported desquamation, dry skin, face pain, irritation and stinging sensation.
","Pregnancy: Tazarotene is not recommended during pregnancy. It has been shown to cause serious birth defects and problems in animals. Be sure you have discussed this with your doctor.
Nursing Mothers: It is not known whether tazarotene passes into breast milk. However, Tazarotene is not recommended during breast-feeding because it may cause unwanted effects in nursing babies.
","Tazarotene cream should be applied only to the affected areas. For external use only. Avoid contact with eyes, eyelids and mouth. If contact with eyes occurs, rinse thoroughly with water. Retinoids should not be used on eczematous skin, as they may cause severe irritation. Patients must be warned to use sunscreens and protective clothing when using Tazarotene cream. Some individuals may experience excessive pruritus, burning, skin redness or peeling. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the dosing should be reduced
","Pediatric Use: Studies of this medicine have been done only in adult patients, and there is no specific information comparing use of Tazarotene in children up to 12 years of age (gel) and up to 18 years of age (cream) with use in other age groups.
Elderly Use (Over 65 year): There is no specific information comparing the use of Tazarotene in the elderly with use in other age groups.
","Excessive topical use cause marked redness, peeling or discomfort. Accidental oral ingestion produces similar adverse effects as those associated with excessive oral intake of Vitamin A or other retinoids. Monitor and take supportive measures as necessary.
",,,"Store at 25° C.
",12
+1033,Tapentadol Hydrochloride,tapentadol-hydrochloride-1033,https://medex.com.bd/attachments/Acd6dkvsDtUNLHYpCGOQXXfvuL6FuX/tapentadol-hydrochloride-prescribing-information,Opioid analgesics,Pain,"Tapentadol is indicated for the relief of moderate to severe acute pain in patients 18 years of age or older.
","Opioid analgesics
","Tapentadol is a centrally-acting synthetic analgesic. It is 18 times less potent than morphine in terms of binding to human mu-opioid receptors. It also increases norepinephrine concentrations in the brains of rats via inhibition of norepinephrine reuptake. Selective mu-opioid antagonists like naloxone can block analgesia from tapentadol. It also has not effect on the QT interval.
Tapendadol causes large increases in levels of extracellular norepinephrine (NE) due to a dual mechanism of action involving mu opioid receptor (MOR) agonism as well as noradrenaline reuptake inhibition.
","As with many centrally-acting analgesic medications, the dosing regimen should be individualized according to the severity of pain being treated, the previous experience with similar drugs and the ability to monitor the patient.
The dose is 50 mg, 75 mg, or 100 mg every 4 to 6 hours depending upon pain intensity. On the first day of dosing, the second dose may be administered as soon as one hour after the first dose, if adequate pain relief is not attained with the first dose. Subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours and should be adjusted to maintain adequate analgesia with acceptable tolerability.
Daily doses greater than 700 mg on the first day of therapy and 600 mg on subsequent days have not been studied and are not recommended.
",,"Increased risk of serotonin syndrome with other drugs that enhance monoaminergic neurotransmission (e.g. TCAs, triptans, SSRIs, serotonin and norepinephrine reuptake inhibitors). Enhanced sedative effect with benzodiazepines, barbiturates, antipsychotics, H1-antihistamines and other opioids. Increased potential for addiction with mixed μ-opioid agonists/antagonists (e.g. nalbuphine, pentazocine) or partial μ-opioid agonists (e.g. buprenorphine). Increased systemic exposure with strong inhibitors of UGT1A6, UGT1A9 and UGT2B7 isoenzymes. Decreased efficacy with strong enzyme inducers (e.g. rifampicin, phenobarbital).
","This drug is contraindicated in patients with impaired Pulmonary Function, It is also contraindicated in patients with acute or severe bronchial asthma or hypercapnia in unmonitored settings or the absence of resuscitative equipment. This drug is contraindicated in any patient who has or is suspected of having paralytic ileus.
","The following treatment-emergent adverse events may happen: heart rate increased, heart rate decreased, visual disturbance, abdominal discomfort, impaired gastric emptying, irritability, edema, drug withdrawal syndrome, hypersensitivity, involuntary muscle contractions, sensation of heaviness, hypoesthesia, paresthesia, disturbance in attention, sedation, dysarthria, memory impairment, ataxia, presyncope, syncope, coordination abnormal, seizure, urticaria, blood pressure decreased etc.
","Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. This preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Neonates whose mothers have been taking Tapentadol should be monitored for respiratory depression.
","Tapentadol should be administered with caution to patients with conditions accompanied by hypoxia, hypercapnia respiratory problems such as: asthma, chronic obstructive pulmonary disease etc. Besides this in case of patient with sleep apnea syndrome, myxedema, kyphoscoliosis, central nervous system (CNS) depression should have to be cautious prior administration of Tapentadol. Patients receiving other mu-opioid agonist analgesics, general anesthetics, phenothiazines, other tranquilizers, sedatives, hypnotics, or other CNS depressants (including alcohol) concomitantly with Tapentadol may exhibit additive CNS depression.
","Pediatric use: The safety and effectiveness of Tapentadol in pediatric patients less than 18 years of age have not been established.
Use in elderly patients: In general, recommended dosing for elderly patients with normal renal and hepatic function is the same as for younger adult patients with normal renal and hepatic function. consideration should be given to starting elderly patients with the lower range of recommended doses.
Use in Renal Disease: In patients with severe renal impairment, the safety and effectiveness of Tapentadol has not been established.
Use in Hepatic Disease: Tapentadol should be used with caution in patients with moderate hepatic impairment. Tapentadol has not been studied in patients with severe hepatic impairment.
","Symptoms: Vomiting, miosis, CV collapse, consciousness disorders up to coma, convulsions and resp depression up to resp arrest.
Management: Re-establish a patent airway and institute assisted or controlled ventilation. GI decontamination with activated charcoal or by gastric lavage may be considered within 2 hr after intake. Pure opioid receptor antagonists (e.g. naloxone) may be given as antidote.
",,,"Store in a cool and dry place, protected from light and moisture. Keep the medicine out of the reach of children.
",12
+1031,Tamsulosin Hydrochloride + Dutasteride,tamsulosin-hydrochloride-dutasteride-1031,https://medex.com.bd/attachments/7R9XqM2FdsZOWVM2YNdgLePYqulJU2/tamsulosin-hydrochloride-dutasteride-prescribing-information,BPH/ Urinary retention/ Urinary incontinence,Benign prostatic hyperplasia (BPH),"Tamsulosin Hydrochloride & Dutasteride capsule is indicated in-
+
+- Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH).
+- Reduction in the risk of acute urinary retention and surgery in patients with moderate to severe symptoms of BPH.
+
","BPH/ Urinary retention/ Urinary incontinence
","Tamsulosin & Dutasteride is a combination of two drugs with complementary mechanisms of action to improve symptoms in patients with Benign Prostatic Hyperplasia (BPH). Tamsulosin Hydrochloride, an antagonist of alpha1A-adrenoreceptors and Dutasteride, a dual 5 alpha reductase inhibitor (5ARI). Treatment of BPH with alpha1-adrenoreceptor blocking agents and 5ARIs results in an improvement in urine flow rate and a reduction in symptoms of BPH.
Tamsulosin: An alpha1-adrenoreceptor blocking agent that affects the dynamic component of BPH by inhibiting alpha1-adrenoreceptors in the stromal prostatic smooth muscle and bladder neck. Blockade of these adrenoreceptors can cause smooth muscles in the bladder neck and prostate to relax. Specifically, Tamsulosin exhibits selectivity for both alpha 1A and alpha 1D receptors over the alpha1B-adrenoreceptor subtype. These three adrenoreceptor subtypes have a distinct distribution pattern in human tissue. Whereas approximately 70% of the alpha1-receptors in human prostate are of the alpha 1A subtype, the human bladder contains predominantly the alpha 1D subtype while blood vessels express predominantly alpha 1B subtype. It is further believed that blockade of the alpha 1D subtypes in the human obstructed bladder may be responsible for reducing detrusor overactivity and subsequent relief of storage symptoms.
Dutasteride: A synthetic 4-azasteriod compound is a competitive and specific inhibitor of both Type I and Type II 5 alpha-reductase isoenzymes that affects the static component of BPH by inhibiting the conversion of Testosterone to Dihydrotestosterone (DHT) by the enzyme 5 alpha-reductase. 5 alpha-reductase exists as 2 isoforms, Type I and Type II, both of which are present in the prostate. It has been observed that compared to normal tissue, the expression of both isoenzymes are increased in BPH tissue. Dissociation from this complex has been evaluated under in vitro and in vivo conditions and is extremely slow. Dutasteride lowers DHT levels and leads to a reduction in prostatic volume, thereby treating an underlying cause of BPH. Dutasteride does not bind to the human androgen receptor.
","Adults (including elderly): The recommended dose is one capsule (Tamsulosin Hydrochloride 0.4 mg & Dutasteride 0.5 mg) taken orally approximately 30 minutes after the same meal each day. The capsules should be swallowed whole and not chewed or opened. Where appropriate, this capsule may be used to substitute concomitant Tamsulosin Hydrochloride and Dutasteride in existing dual therapy to simplify treatment. Where clinically appropriate, direct change from Tamsulosin Hydrochloride or Dutasteride monotherapy to this capsule may be considered.
Renal impairment: The effect of renal impairment on Tamsulosin-Dutasteride pharmacokinetics has not been studied. No adjustment in dosage is anticipated for patients with renal impairment.
Hepatic impairment: The effect of hepatic impairment on Tamsulosin-Dutasteride pharmacokinetics has not been studied so caution should be used in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the use of this capsule is contra-indicated.
",,"There have been no drug interaction studies for Dutasteride-Tamsulosin combination.
Effects of other drugs on the pharmacokinetics of Dutasteride: Use together with CYP3A4 and/or P-glycoprotein-inhibitors: Dutasteride is mainly eliminated via metabolism. In vitro studies indicate that this metabolism is catalysed by CYP3A4 and CYP3A5. No formal interaction studies have been performed with potent CYP3A4 inhibitors. However, in a population pharmacokinetic study, Dutasteride serum concentrations were on average 1.6 to 1.8 times greater, respectively, in a small number of patients treated concurrently with verapamil or diltiazem (moderate inhibitors of CYP3A4 and inhibitors of P-glycoprotein) than in other patients. Long-term combination of Dutasteride with drugs that are potent inhibitors of the enzyme CYP3A4 (e.g. ritonavir, indinavir, nefazodone, itraconazole, ketoconazole administered orally) may increase serum concentrations of Dutasteride. Further inhibition of 5-alpha reductase at increased Dutasteride exposure, is not likely. However, a reduction of the Dutasteride dosing frequency can be considered if side effects are noted. It should be noted that in the case of enzyme inhibition, the long half-life may be further prolonged and it can take more than 6 months of concurrent therapy before a new steady state is reached. Administration of 12 g cholestyramine one hour after a 5 mg single dose of Dutasteride did not affect the pharmacokinetics of Dutasteride.
Effects of Dutasteride on the pharmacokinetics of other drugs: In a small study (N=24) of two weeks duration in healthy men, Dutasteride (0.5 mg daily) had no effect on the pharmacokinetics of Tamsulosin or terazosin. There was also no indication of a pharmacodynamic interaction in this study. Dutasteride has no effect on the pharmacokinetics of warfarin or digoxin. This indicates that Dutasteride does not inhibit/induce CYP2C9 or the transporter P-glycoprotein. In vitro interaction studies indicate that Dutasteride does not inhibit the enzymes CYP1A2, CYP2D6, CYP2C9, CYP2C19 or CYP3A4. Tamsulosin: Concomitant administration of Tamsulosin Hydrochloride with drugs which can reduce blood pressure, including anaesthetic agents, PDE5 inhibitors and other alpha-1 adrenergic blockers could lead to enhanced hypotensive effects. Tamsulosin-Dutasteride should not be used in combination with other alpha-1 adrenergic blockers. Concomitant administration of Tamsulosin Hydrochloride (0.4 mg) and cimetidine (400 mg every six hours for six days) resulted in a decrease in the clearance (26%) and an increase in the AUC (44%) of Tamsulosin Hydrochloride. Caution should be used when Tamsulosin-Dutasteride is used in combination with cimetidine. A definitive drug-drug interaction study between Tamsulosin Hydrochloride and warfarin has not been conducted. Results from limited in vitro and in vivo studies are inconclusive. Caution should be exercised with concomitant administration of warfarin and Tamsulosin Hydrochloride. No interactions have been seen when Tamsulosin Hydrochloride was given concomitantly with either atenolol, enalapril, nifedipine or theophylline. Concomitant furosemide brings about a fall in plasma levels of Tamsulosin, but as levels remain within the normal range posology need not be adjusted. In vitro neither diazepam nor propranolol, trichlormethiazide, chlormadinon, amitryptyline, diclofenac, glibenclamide and simvastatin change the free fraction of Tamsulosin in human plasma. Neither does Tamsulosin change the free fractions of diazepam, propranolol, trichlormethiazide, and chlormadinon. No interactions at the level of hepatic metabolism have been seen during in vitro studies with liver microsomal fractions, involving amitriptyline, salbutamol and glibenclamide. Diclofenac however, may increase the elimination rate of Tamsulosin.
","Tamsulosin-Dutasteride combination is contra-indicated in women and children and adolescents, patients with hypersensitivity to Dutasteride, other 5-alpha reductase inhibitors, Tamsulosin (including Tamsulosin- induced angio-edema), soya, peanut or any of other the excipients, patients with a history of orthostatic hypotension and patients with severe hepatic impairment.
","The most common adverse reactions reported in subjects receiving combination therapy were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders and dizziness. The percentages of subjects with ejaculation disorders, decreased libido and impotence were higher in the combination therapy group compared with either monotherapy groups.
","Tamsulosin-Dutasteride combination is contra-indicated for use by women. There have been no studies to investigate the effect of Tamsulosin-Dutasteride combination on pregnancy, lactation and fertility. The following statements reflect the information available from studies with the individual components. Fertility: Dutasteride has been reported to affect semen characteristics (reduction in sperm count, semen volume, and sperm motility) in healthy men. The possibility of reduced male fertility cannot be excluded. Effects of Tamsulosin Hydrochloride on sperm counts or sperm function have not been evaluated.
Pregnancy: As with other 5 alpha reductase inhibitors, Dutasteride inhibits the conversion of testosterone to dihydrotestosterone and may, if administered to a woman carrying a male foetus, inhibit the development of the external genitalia of the foetus. Small amounts of Dutasteride have been recovered from the semen in subjects receiving Dutasteride. It is not known whether a male foetus will be adversely affected if his mother is exposed to the semen of a patient being treated with Dutasteride. As with all 5 alpha reductase inhibitors, when the patient’s partner is or may potentially be pregnant it is recommended that the patient avoids exposure of his partner to semen by use of a condom. Administration of Tamsulosin Hydrochloride to pregnant female rats and rabbits showed no evidence of foetal harm.
Lactation: It is not known whether Tamsulosin or Dutasteride are excreted in human milk.
","Combination therapy should be prescribed after careful benefit risk assessment due to the potential increased risk of adverse events (including cardiac failure) and after consideration of alternative treatment options including monotherapies.
Cardiac failure: In two 4-year clinical studies, the incidence of cardiac failure was higher among subjects taking the combination of Dutasteride and an alpha blocker, primarily Tamsulosin, than it was among subjects not taking the combination. In these two trials, the incidence of cardiac failure was low (1%) and variable between the studies.
Effects on prostate specific antigen (PSA) and prostate cancer detection: Digital rectal examination, as well as other evaluations for prostate cancer or other conditions which can cause the same symptoms as BPH, must be performed on patients prior to initiating therapy with Tamsulosin-Dutasteride combination and periodically thereafter. Serum prostate-specific antigen (PSA) concentration is an important component in the detection of prostate cancer. Tamsulosin-Dutasteride combination causes a decrease in mean serum PSA levels by approximately 50%, after 6 months of treatment. Patients receiving Tamsulosin-Dutasteride combination should have a new PSA baseline established after 6 months of treatment. It is recommended to monitor PSA values regularly thereafter. Any confirmed increase from lowest PSA level while on Tamsulosin-Dutasteride combination may signal the presence of prostate cancer or noncompliance to therapy with Tamsulosin-Dutasteride combination and should be carefully evaluated, even if those values are still within the normal range for men not taking a 5 alpha-reductase inhibitor. In the interpretation of a PSA value for a patient taking Tamsulosin-Dutasteride combination, previous PSA values while on Dutasteride treatment should be sought for comparison. Treatment with Tamsulosin-Dutasteride combination does not interfere with the use of PSA as a tool to assist in the diagnosis of prostate cancer after a new baseline has been established. Total serum PSA levels return to baseline within 6 months of discontinuing treatment. The ratio of free to total PSA remains constant even under the influence of Tamsulosin-Dutasteride combination. If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men undergoing Tamsulosin-Dutasteride combination therapy, no adjustment to its value appears necessary.
Prostate cancer and high grade tumours: Results of one clinical study in men at increase risk of prostate cancer revealed a higher incidence of Gleason 8-10 prostate cancers in Dutasteride treated men compared to placebo. The relationship between Dutasteride and high grade prostate cancer is not clear. Men taking Tamsulosin-Dutasteride combination should be regularly evaluated for prostate cancer risk including PSA testing.
Renal impairment: The treatment of severely renally impaired patients (creatinine clearance of less than 10 ml/min) should be approached with caution as these patients have not been studied.
Hypotension: Orthostatic- As with other alpha-blockers, a reduction in blood pressure can occur during treatment with Tamsulosin, as a result of which, rarely, syncope can occur. Patients beginning treatment with Tamsulosin-Dutasteride combination should be cautioned to sit or lie down at the first signs of orthostatic hypotension (dizziness, weakness) until the symptoms have resolved. In order to minimize the potential for developing postural hypotension the patient should be haemodynamically stable on alpha-blocker therapy prior to initiating use of PDE5 inhibitors. Symptomatic: Caution is advised when alpha adrenergic blocking agents including Tamsulosin are coadministered with PDE5 inhibitors (e.g. sildenafil, tadalafil, vardenafil). Alpha adrenergic blockers and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension.
Intraoperative Floppy Iris Syndrome: Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients on or previously treated with Tamsulosin. IFIS may lead to increased procedural complications during the operation. The initiation of therapy with Tamsulosin-Dutasteride combination in patients for whom cataract surgery is scheduled is therefore not recommended. Discontinuing Tamsulosin 1-2 weeks prior to cataract surgery is anecdotally considered helpful, but the benefit and duration of stopping therapy prior to cataract surgery has not yet been established. Leaking Capsule: Dutasteride is absorbed through the skin, therefore, women, children and adolescents must avoid contact with leaking capsules. If contact is made with leaking capsules, the contact area should be washed immediately with soap and water.
Hepatic impairment: Tamsulosin-Dutasteride combination has not been studied in patients with liver disease. Caution should be used in the administration of Tamsulosin-Dutasteride combination to patients with mild to moderate hepatic impairment.
Breast neoplasia: Breast cancer has been reported in men taking Dutasteride in clinical trials and during the post-marketing period. Physicians should instruct their patients to promptly report any changes in their breast tissue such as lumps or nipple discharge. Currently it is not clear if there is a causal relationship between the occurrence of male breast cancer and long term use of Dutasteride.
",,"No data are available with regard to over dosage of Tamsulosin-Dutasteride combination. The following statements reflect the information available on the individual components.
Dutasteride: In volunteer studies, single daily doses of Dutasteride up to 40 mg/day (80 times the therapeutic dose) have been administered for 7 days without significant safety concerns. In clinical studies, doses of 5 mg daily have been administered to subjects for 6 months with no additional adverse effects to those seen at therapeutic doses of 0.5 mg. There is no specific antidote for Dutasteride, therefore, in suspected over dosage symptomatic and supportive treatment should be given as appropriate.
Tamsulosin: Acute overdose with 5 mg Tamsulosin Hydrochloride has been reported. Acute hypotension (systolic blood pressure 70 mm Hg), vomiting and diarrhoea were observed which were treated with fluid replacement and the patient could be discharged the same day. In case of acute hypotension occurring after over dosage cardiovascular support should be given. Blood pressure can be restored and heart rate brought back to normal by lying the patient down. If this does not help then volume expanders, and when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as Tamsulosin is very highly bound to plasma proteins. Measures, such as emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate, can be administered.
",,,"Store in a cool and dry place, protected from light.
",11
+1032,Tamsulosin Hydrochloride,tamsulosin-hydrochloride-1032,https://medex.com.bd/attachments/lv8gvFaOachvgeoZ2wMYiPZRI8fT7b/tamsulosin-hydrochloride-prescribing-information,BPH/ Urinary retention/ Urinary incontinence,Benign prostatic hyperplasia (BPH),"Tamsulosin Hydrochloride is indicated for the treatment of functional symptoms of Benign Prostatic Hyperplasia (BPH).
","BPH/ Urinary retention/ Urinary incontinence
","Tamsulosin, a selective alpha1 adrenoceptor blocking agent, exhibits its selectivity for alpha1 A adrenoceptors in human prostate. Blockade of these adrenoceptors can cause smooth muscle in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in symptoms of BPH. Absorption of Tamsulosin hydrochloride capsule 0.4mg is essentially complete (90%) following oral administration under fasting conditions. The time to maximum concentration (Tmax) is reached by four to five hours under fasting conditions and by six to seven hours when administered with food. Tamsulosin hydrochloride is extremely bound to human plasma protein (94% to 99%). Tamsulosin hydrochloride is extensively metabolized by cytochrome P 450 enzymes in the liver and less than 10% of the dose is excreted in urine as unchanged form. Following intravenous or oral administration of an immediate-release formulation the elimination half-life of Tamsulosin hydrochloride in plasma ranges from five to seven hours. Because of the absorption rate controlled pharmacokinetics with Prostam capsules, the apparent half-life of Tamsulosin hydrochloride is approximately 9 to 13 hours in healthy volunteers and 14 to 15 hours in the target population.
","Tamsulosin Hydrochloride 0.4 mg (one capsule) daily, to be taken after meal at night. The dose may be increased after 2 to 4 weeks, if necessary, to Tamsulosin Hydrochloride 0.8 mg (two capsules) once daily. If Tamsulosin Hydrochloride administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the Tamsulosin Hydrochloride 0.4 mg (one capsule) once daily dose. The capsule should be swallowed whole with a glass of water (about 150 ml) in the standing or sitting position. The capsule should not be crunched or chewed, as this will interfere with the modified release of the active ingredient.
",,"Concurrent administration of other alfa1-adrenoceptor antagonists could lead to hypotensive effects. No interactions have been seen when Tamsulosin was given concomitantly with either atenolol, enalapril or nifedipine. Concomitant cimetidine brings about a rise and frusemide a fall in plasma levels of Tamsulosin, but as levels remain within the normal range posology need not be changed. No interactions at the level of hepatic metabolism have been seen during in vitro studies with liver microsomal fractions (representative of the cytochrome P450-linked drug-metabolizing enzyme system), involving amitriptyline, salbutamol, glibenclamide, and finasteride. Diclofenac and warfarin, however, may increase the elimination rate of Tamsulosin.
","Tamsulosin hydrochloride is contraindicated in patients with hypersensitivity to it; history of orthostatic hypotension; severe hepatic insufficiency.
As with other alpha1 blockers, a reduction in blood pressure can occur in individual cases during treatment with Tamsulosin, as a result of which, rarely, syncope can occur, at the first signs of orthostatic hypotension (dizziness, weakness) the patient should sit or lie down until the symptoms have disappeared. And they should be cautioned to avoid situations where injury could result (like driving, operating machinery or performing hazardous tasks).
Before therapy with Tamsulosin is initiated the patient should be examined in order to exclude the presence of other conditions which can cause the same symptoms as Benign Prostatic hyperplasia. Digital rectal examination and when the necessary determination of Prostate Specific Antigen (PSA) should be performed before treatment and at regular intervals afterwards.
","The following adverse reactions have been reported during the use of Tamsulosin: dizziness, abnormal ejaculation and; less frequently headache, asthenia, postural hypotension and palpitations.
","Use of Tamsulosin in pregnancy and lactation is not recommended.
","Rarely, transient postural symptoms have occurred during orthostatic provocation testing after the first dose. Use in patients with micturition syncope is not advised.
Effects on ability to drive and use machines: No data is available on whether Tamsulosin adversely affects the ability to drive or operate machines. However, in this respect, patients should be aware of the fact that dizziness can occur.
",,"No case of acute overdosage has been reported. However, acute hypotension is likely to occur after overdosage in which case cardiovascular support should be given. Blood pressure can be restored and the heart rate brought back to normal by lying the patient down. If this does not help then volume expanders, and when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as Tamsulosin is very highly bound to plasma proteins. Measures, such as emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate, can be administered.
",,,"Store in a cool and dry place, below 30°C, protected from light.
",11
+1030,Tamoxifen Citrate,tamoxifen-citrate-1030,https://medex.com.bd/attachments/s4lcL557YjneNtazK9TGWccbe6f9dY/tamoxifen-citrate-prescribing-information,Hormonal Chemotherapy,Breast cancer,"Tamoxifen is indicated for the treatment of breast cancer.
","Hormonal Chemotherapy
","Tamoxifen is a praparation of Tamoxifen which is a non-steroidal, triphenylene based drug and displays a complex spectrum of oestrogen antagonist and oestrogen agonist like pharmacological effects in different tissues. In breast cancer patients, at the tumour level, Tamoxifen acts primarily as an antioestrogen, preventing oestrogen binding to the oestrogen receptor. Additionally Tamoxifen has been reported to lead to maintenance of bone mineral density in post-menopausal women.
","Adults (including elderly): The dosage range is 20 to 40 mg daily, given either in divided doses twice daily or as a single dose once daily.
",,"When Tamoxifen is used in combination with coumarin type anticoagulants, a significant increase in anticoagulant effect may occur. Where such co administration is initiated, careful monitoring of the patient is recommended. When Tamoxifen is used in combination with cytotoxic agents, there is an increased risk of thromboembolic events.
","Tamoxifen must not be administered during pregnancy. Tamoxifen should not be given to patients who have experienced hypersensitivity to the product or any of its ingredients.
","Side effects can be classified as either due to the pharmacological action of the drug, e.g., hot flushes, vaginal bleeding, vaginal discharge, pruritus vulvae and tumour flare or as more general side effects, e.g., gastrointestinal intolerance, headache, light-headedness and occasionally fluid retention and alopecia. When such side effects are severe, it may be possible to control them by a simple reduction of dosage (within the recommended dose range) without loss of control of the disease.
Skin rashes including isolated reports of erythema multiforme, Stevens Johnson syndrome and bullous pemphigoid and rare hypersensitivity reactions, including angio-oedema have been reported. A small number of patients with bony metastases have developed hypercalcaemia on initiation of therapy.
Falls in platelet count, usually only to 80,000-90,000 per/mm3 but occasionally lower, have been reported in patients taking Tamoxifen for breast cancer.
A number of cases of visual disturbances including infrequent reports of corneal changes and retinopathy have been described in patients receiving Tamoxifen therapy. An increased incidence of cataracts has been reported in association with the administration of the drug. Uterine fibroids and endometrial changes including hyperplasia and polyps have been reported. Cystic ovarian swellings have occasionally been observed in premenopausal women receiving Tamoxifen.
Leucopenia has been observed following the administration of Tamoxifen, sometimes in association with anaemia and/or thrombocytopenia. Neutropenia has been reported on rare occasions; this can sometimes be severe. There is evidence of an increased incidence of thromboembolic events including deep vein thrombosis and pulmonary embolism during Tamoxifen therapy.
Tamoxifen has been associated with changes in liver enzyme levels and on rare occasions with a spectrum of more severe liver abnormalities, including fatty liver, cholestasis and hepatitis. Rarely, elevation of serum triglyceride levels, in some cases with pancreatitis, may be associated with the use of Tamoxifen.
","Pregnancy: Tamoxifen must not be administered during pregnancy. There have been a small number of reports of spontaneous abortions, birth defects and foetal deaths after women have taken Tamoxifen, although no causal relationship has been established. Reproductive toxicology studies in rats, rabbits and monkeys have shown no teratogenic potential.
Women should be advised not to become pregnant whilst taking Tamoxifen and should use barrier or other nonhormonal contraceptive methods if sexually active. Premenopausal patients must be carefully examined before treatment to exclude pregnancy. Women should be informed of the potential risks to the foetus, if they want to become pregnant whilst taking Tamoxifen or within two months of cessation of therapy.
Lactation: It is not known if Tamoxifen is excreted in human milk and therefore the drug is not recommended during lactation. The decision to discontinue Tamoxifen should take into account in case of the importance of the drug to the lactating mother.
","Menstruation is suppressed in a proportion of premenopausal women receiving Tamoxifen for the treatment of breast cancer. An increased incidence of endometrial cancer has seen reported in association with Tamoxifen treatment. The underlying mechanism is unknown, but may be related to the oestrogen-like effect of Tamoxifen. Any patients receiving or having previously received Tamoxifen, who report abnormal gynaecological symptoms, especially vaginal bleeding, should be promptly investigated.
A number of second primary tumors, occurring at sites other than the endometrium and the opposite breast, have been reported in clinical trials, following the treatment of breast cancer patients with Tamoxifen. No causal link has been established and the clinical significance of these observations remains unclear.
",,,,,"Store between 20-25° C. Protect from light.
",10
+1375,Tafluprost,tafluprost-1375,https://medex.com.bd/attachments/v8OwdU8RoQux4DPQ2TBxg6xWrzw7la/tafluprost-prescribing-information,Drugs for miotics and glaucoma,Open angle glaucoma,"Tafluprost is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
","Drugs for miotics and glaucoma
","Tafluprost, a prostaglandin analog is a selective FP prostanoid receptor agonist which is believed to reduce intraocular pressure by increasing uveoscleral outflow of aqueous humor.
","Instill one drop in the affected eye(s) once daily in the evening.
",,,"Tafluprost ophthalmic solution is contraindicated in patients who are hypersensitive to any component of this product.
","The most frequently reported treatment-related side effect is ocular hyperemia. Rare side effects observed include eye irritation and blurred vision.
","Use in pregnancy: Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Tafluprost ophthalmic solution should be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether Tafluprost is excreted in human milk. Caution should be exercised while giving this ophthalmic solution to a nursing mother.
","
+- For ophthalmic use only.
+- To avoid possible contamination of the drops, do not touch the dropper tip or to any surface.
+- Should be used with caution in patients with active intraocular inflammation (e.g., iritis/uveitis).
+- If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes between applications.
+
","Use in children: Use in pediatric patients is not recommended.
Use in elderly patients: No overall differences in safety and effectiveness have been observed between elderly and other adult patients.
",,,,,9
+1029,Tadalafil,tadalafil-1029,https://medex.com.bd/attachments/WWlzqpeuPqlq0fXgTxG32RXNFYSX6r/tadalafil-prescribing-information,Drugs for Erectile Dysfunction,Pulmonary arterial hypertension,"Tadalafil is indicated in-
+
+- Erectile Dysfunction (ED)
+- Benign Prostatic Hyperplasia (BPH)
+- Both Erectile Dysfunction and signs and symptoms of Benign Prostatic Hyperplasia
+
","Drugs for Erectile Dysfunction
","Tadalafil is a selective phosphodiesterase type 5 (PDE5) inhibitor. Inhibition of PDE5 increases cGMP in smooth muscle cells. cGMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum, causing penile erection. PDE5 also is present in smooth muscles of the prostate and bladder wall. Inhibiting PDE5 increases cGMP concentrations leading to relaxation of smooth muscle in the prostate and bladder. Smooth muscle relaxation may improve blood flow to the urinary tract and widen the opening of the bladder neck, resulting in improved voiding.
","Erectile Dysfunction: For most patients the recommended starting dose is 10 mg. The dose may be increased to 20 mg or decreased to 5 mg based on requirement. The maximum dosing frequency is once daily. Tadalafil is effective for up to 36 hours.
Benign prostatic hyperplasia: The recommended dose is 5 mg taken at the same time every day.
Combined Erectile Dysfunction and Benign prostatic hyperplasia: The recommended dose is 5 mg at the same time every day.
",,"May interact with Nitrates for example, Isosorbide, Nitroglycerin, Alpha adrenergic blockers, Antihypertensives, Alcohol, Antacids (magnesuim hydroxide/aluminum hydroxide), Ketoconazole, Ritonavir, Erythromycin, Itraconazole, Grapefruit juice, other HIV protease inhibitors, Rifampin, Carbamazepine, Phenytoin & Phenobarbital.
","
+- Use of Nitrates (for example, Nitroglycerine, Isosorbide): may increase hypotensive effects of Nitrates
+- Hypersensitivity reactions to Tadalafil
+
","Headache, Dyspepsia, Back pain, Myalgia, Nasal pharyngitis, Nasal congestion are common side effects. Change in Color Vision, Sudden vision loss, Hearing loss, Stevens-Johnson Syndrome, Exfoliative dermatitis, Angina, Stroke, Myocardial infarction, Severe hypotension, Tachycardia may also occur rarely.
","Tadalafil has been assigned to pregnancy category B by the USFDA. Tadalafil is only recommended for use during pregnancy when benefit outweighs risk. There are no data on the excretion of Tadalafil in human milk. Caution should be used when administering tadalafil to nursing women.
","Angina, renal impairment, hepatic impairment, bleeding concomitant with Nitrates, Alpha Blockers, Alcohol, CYP3A4 Inhibitors (for example, Ritonavir, Ketoconazole, Itraconazole), other PDE5 inhibitors precaution should be taken in all these conditions.
",,,,,"Keep in a dry place, away from light and heat. Keep out of the reach of children.
",10
+1028,Tacrolimus (Topical),tacrolimus-topical-1028,https://medex.com.bd/attachments/ZdiNZQpk9QOz8KcmEBzNabqZk3VcCK/tacrolimus-topical-prescribing-information,Drugs affecting the immune response,Vitiligo,"Tacrolimus ointment is indicated for short-term and intermittent long-term therapy in the treatment of patients with moderate to severe atopic dermatitis in whom the use of alternative, conventional therapies are deemed inadvisable because of potential risks, or in the treatment of patients who are ... Read more
Tacrolimus ointment is indicated for short-term and intermittent long-term therapy in the treatment of patients with moderate to severe atopic dermatitis in whom the use of alternative, conventional therapies are deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or are intolerant of alternative, conventional therapies. Tacrolimus ointment is also indicated in other skin conditions such as chronic cutaneous graft-vs-host disease, hand and foot eczema, allergic contact dermatitis, vitiligo, psoriasis, lichen planus, facial lichen, vulvar lichen sclerosus, pyoderma gangrenosum, leg ulcers in rheumatoid arthritis, steroid-induced rosacea & alopecia areata, annular erythema, chronic actinic dermatitis and recalcitrant facial erythema.
","Drugs affecting the immune response
","Tacrolimus is a macroiide immunomodulator produced by fungus, Streptomyces tsukubaensis. It has been demonstrated that Tacrolimus inhibits T-lymphocyte activation by first binding to an intracellular protein, FKBP-12. A complex of Tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. This leads to a general decrease in the entire inflammatory cascade.
","Use in adults: Apply a thin layer of Tacrolimus ointment onto the affected skin areas twice daily and rub in gently and completely. Treatment should be continued for one week after clearing of signs and symptoms of atopic dermatitis. The safety of Tacrolim ointment under occlusion which may promote systemic exposure has not been evaluated. Tacrolimus ointment should not be used with occlusive dressings.
Use in Children:
+
+- Tacrolimus 0.03% ointment can be used in pediatric patients 2 years of age and older.
+- Tacrolimus 0.1% ointment can be used in children 16 years of age and older.
+
+
Use in Elderly Patients: Patients >65 years old received Tacrolimus ointment in phase 3 studies. The adverse event profile for these patients was consistent with that for other adult patients.
",,"Formal topical drug interaction studies with Tacrolimus ointment have not been conducted. The concomitant administration of known CYP3A4 inhibitors in patients with widespread and/or erythrodermic disease should be done with caution. Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine.
","Tacrolimus ointment is contraindicated in patients with a history of hypersensitivity to Tacrolimus or any other component of the preparation.
","Topically applied Tacrolimus ointment have very few and rare type of side-effects including skin burning, pruritus, flu-like symptoms, allergic reactions, skin erythema, skin infections, headache, etc.
","Pregnancy Category C. There are no adequate and well-controlled studies of topically administered Tacrolimus in pregnant women. Although systemic absorption of Tacrolimus following topical applications of Tacrolimus ointment is minimal relative to systemic administration, it is known that Tacrolimus is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Tacrolimus, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","Cautions should be exercised while treatment with Tacrolimus ointment in patients with atopic dermatitis predisposed to superficial skin infections. The safety of Tacrolimus ointment has not been established in patients with generalized erythroderma.
",,"Tacrolimus ointment is not for oral use. Accidental oral ingestion of Tacrolimus ointment may lead to adverse effects associated with systemic administration of Tacrolimus. If oral ingestion occurs, medical advice should be sought.
",,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",11
+1356,Tacrolimus (Oral),tacrolimus-oral-1356,https://medex.com.bd/attachments/x7Y9BG6wImEkcm9ImhULsuei99Bppw/tacrolimus-oral-prescribing-information,Drugs affecting the immune response,Prophylaxis of acute renal graft rejection,"Tacrolimus is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants
","Drugs affecting the immune response
","Tacrolimus inhibits T-lymphocyte activation, although the exact mechanism of action is not known. Experimental evidence suggests that Tacrolimus binds to an intracellular protein, FKBP-12. A complex of Tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin is then formed and the phosphatase activity of calcineurin inhibited. This effect may prevent the dephosphorylation and translocation of nuclear factor of activated T-cells (NF-AT), a nuclear component thought to initiate gene transcription for the formation of lymphokines (such as interleukin-2, gamma interferon). The net result is the inhibition of T-lymphocyte activation (i.e., immunosuppression).
Tacrolimus prolongs the survival of the host and transplanted graft in animal transplant models of liver, kidney, heart, bone marrow, small bowel and pancreas, lung and trachea, skin, cornea, and limb.
In animals, Tacrolimus has been demonstrated to suppress some humoral immunity and, to a greater extent, cell-mediated reactions such as allograft rejection, delayed type hypersensitivity, collagen-induced arthritis, experimental allergic encephalomyelitis, and graft versus host disease.
","Usual Adult Dose for Organ Transplant- Rejection Prophylaxis
+KIDNEY TRANSPLANT:
+
+- In combination with azathioprine: Initial dose: 0.1 mg/kg orally every 12 hours. Initiate within 24 hours of surgery, but delay until renal function has recovered.
+- In combination with mycophenolate mofetil (MMF)/interleukin-2 (IL-2) receptor antagonist: Initial dose: 0.05 mg/kg orally every 12 hours. Initiate within 24 hours of surgery, but delay until renal function has recovered.
+
+LIVER TRANSPLANT:
+
+- Initial dose: 0.05 to 0.075 mg/kg orally every 12 hours. Initiate no sooner than 6 hours after surgery.
+
+HEART TRANSPLANT:
+
+- Initial dose: 0.0375 mg/kg orally every 12 hours. Initiate no sooner than 6 hours after surgery
+
+
+
Usual Pediatric Dose for Organ Transplant- Rejection Reversal
+LIVER TRANSPLANT:
+
+- Initial dose: 0.075 to 0.1 mg/kg orally every 12 hours
+
",,"Since Tacrolimus is metabolized mainly by CYP3A enzymes, drugs or substances known to inhibit these enzymes may increase Tacrolimus whole blood concentrations. Drugs known to induce CYP3A enzymes may decrease Tacrolimus whole blood concentrations. Dose adjustments may be needed along with frequent monitoring of Tacrolimus whole blood trough concentrations when Tacrolimus is administered with CYP3A inhibitors or inducers. In addition, patients should be monitored for adverse reactions including changes in renal function and QT prolongation
","Tacrolimus capsules are contraindicated in patients with a hypersensitivity to Tacrolimus. Tacrolimus injection is contraindicated in patients with a hypersensitivity to HCO-60 (polyoxyl 60 hydrogenated castor oil). Hypersensitivity symptoms reported include dyspnea, rash, pruritus, and acute respiratory distress syndrome
",,"Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Tacrolimus is transferred across the placenta. The use of Tacrolimus during pregnancy in humans has been associated with neonatal hyperkalemia and renal dysfunction. Tacrolimus given orally to pregnant rabbits at 0.5 to 4.3 times the clinical dose and pregnant rats at 0.8 to 6.9 times the clinical dose was associated with an increased incidence of fetal death in utero, fetal malformations (cardiovascular, skeletal, omphalocele, and gallbladder agenesis) and maternal toxicity. Tacrolimus should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
Nursing Mothers: Tacrolimus is excreted in human milk. As the effect of chronic exposure to Tacrolimus in healthy infants is not established, patients maintained on Tacrolimus should discontinue nursing taking into consideration importance of drug to the mother.
",,"Pediatric Use: The safety and efficacy of Tacrolimus in pediatric kidney and heart transplant patients have not been established. Successful liver transplants have been performed in pediatric patients (ages up to 16 years) using Tacrolimus. Two randomized active-controlled trials of Tacrolimus in primary liver transplantation included 56 pediatric patients. Thirty-one patients were randomized to Tacrolimus-based and 25 to cyclosporine-based therapies. Additionally, a minimum of 122 pediatric patients were studied in an uncontrolled trial of Tacrolimus in living related donor liver transplantation. Pediatric patients generally required higher doses of Tacrolimus to maintain blood trough concentrations of Tacrolimus similar to adult patients.
Geriatric Use: Clinical trials of Tacrolimus did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Use in Renal Impairment: The pharmacokinetics of Tacrolimus in patients with renal impairment was similar to that in healthy volunteers with normal renal function. However, consideration should be given to dosing Tacrolimus at the lower end of the therapeutic dosing range in patients who have received a liver or heart transplant and have pre-existing renal impairment. Further reductions in dose below the targeted range may be required
Use in Hepatic Impairment: The mean clearance of Tacrolimus was substantially lower in patients with severe hepatic impairment (mean Child-Pugh score: >10) compared to healthy volunteers with normal hepatic function. Close monitoring of Tacrolimus trough concentrations is warranted in patients with hepatic impairment.
The use of Tacrolimus in liver transplant recipients experiencing post-transplant hepatic impairment may be associated with increased risk of developing renal insufficiency related to high whole-blood trough concentrations of Tacrolimus. These patients should be monitored closely and dosage adjustments should be considered. Some evidence suggests that lower doses should be used in these patients
","Limited overdosage experience is available. Acute overdosages of up to 30 times the intended dose have been reported. Almost all cases have been asymptomatic and all patients recovered with no sequelae. Acute overdosage was sometimes followed by adverse reactions (including tremors, abnormal renal function, hypertension, and peripheral edema); in one case of acute overdosage, transient urticaria and lethargy were observed. Based on the poor aqueous solubility and extensive erythrocyte and plasma protein binding, it is anticipated that Tacrolimus is not dialyzable to any significant extent; there is no experience with charcoal hemoperfusion. The oral use of activated charcoal has been reported in treating acute overdoses, but experience has not been sufficient to warrant recommending its use. General supportive measures and treatment of specific symptoms should be followed in all cases of overdosage.
In acute oral and IV toxicity studies, mortalities were seen at or above the following doses: in adult rats, 52 times the recommended human oral dose; in immature rats, 16 times the recommended oral dose; and in adult rats, 16 times the recommended human IV dose (all based on body surface area corrections).
",,,"Store at 25°C
",10
+1027,Suxamethonium Chloride,suxamethonium-chloride-1027,https://medex.com.bd/attachments/YS3VNaQCKMe0XRfBLHYLbFUmp9TDqa/suxamethonium-chloride-prescribing-information,Depolarizing muscle relaxants,Muscle relaxant,"Suxamethonium Chloride is a short-acting depolarizing neuromuscular blocking agent. It is used in anesthesia as a muscle relaxant to-
+
+- Facilitate endotracheal intubation
+- Aid in mechanical ventilation and
+- Assist a wide range of surgical and obstetric procedures
+
","Depolarizing muscle relaxants
","Suxamethonium is a muscle relaxant. It acts as a depolarizing neuromuscular blocker by imitating the action of acetylcholine at the neuromuscular junction. Suxamethonium acts on muscle type nicotinic receptors. Binding of Suxamethonium to the nicotinic acetylcholine receptor results in opening of the receptor's nicotinic sodium channel; sodium moves into the cell, a disorganized depolarization of the motor-end plate occurs and calcium is released from the sarcoplasmic reticulum. This results in fasciculation. In the normal muscle, following depolarization, acetylcholine is rapidly hydrolyzed by acetylcholinesterase and the muscle cell is able to 'reset' ready for the next signal. But Suxamethonium is degraded not by acetylcholinesterase, rather by butyrylcholinesterase, a plasma cholinesterase. This hydrolysis by butyrylcholinesterase is much slower than that of acetylcholine by acetylcholinesterase. Thus Suxamethonium has a longer duration of effect than acetylcholine and it does not allow the muscle cell to 'reset' and keeps the 'new' resting membrane potential below threshold. When acetylcholine binds to an already depolarized receptor it cannot cause further depolarization. Calcium is removed from the muscle cell cytosol independent of repolarization. As the calcium is taken up by the sarcoplasmic reticulum, the muscle relaxes. This explains muscle flaccidity rather than tetany following fasciculation.
","Suxamethonium Chloride is usually administered by bolus Intravenous or Intramuscular injection.
Adults: The dose of Suxamethonium is dependent on body weight, the degree of muscular relaxation required, the route of administration and the response of individual patients. To achieve endotracheal intubation Suxamethonium is usually administered intravenously in a dose of 1 mg/kg. This dose will usually produce muscular relaxation in about 30-60 seconds and has a duration of action of about 2-6 minutes. Supplementary doses of Suxamethonium of 50%-100% of the initial dose administered at 5-10 minutes intervals will maintain muscle relaxation during short surgical procedures performed under general anesthesia. For prolonged surgical procedures Suxamethonium may be given by intravenous infusion as a 0.1 %-0.2% solution, diluted in 5 % glucose solution or sterile isotonic saline solution, at a rate of 2.5 to 4 mg per minute. The infusion rate should be adjusted according to the response of individual patients. The total dose of Suxamethonium given by repeated intravenous injection or continuous infusion should not be exceeded 500 mg per hour.
Children: Infants and young children are more resistant to Suxamethonium compared with adults. The recommended intravenous dose of Suxamethonium for infants is 2 mg/kg. A dose of 1 mg/kg in older children is recommended. When Suxamethonium is given as intravenous infusion in children, the dosage is as for adults with a proportionately lower initial Infusion rate based on body weight. Suxamethonium may be given intramuscularly to infants at doses up to 4-5 mg/kg and in older children up to 4 mg/kg. These doses produce muscular relaxation within about 3 minutes. A total dose of 150 mg should not be exceeded.
",,"Certain drugs or chemicals are known to reduce normal plasma cholinesterase activity and may therefore prolong the neuromuscular blocking effects of Suxamethonium. These include: trimetaphan; specific anticholinesterase agents: neostigmine, pyridostigmine, physostigmine; cytotoxic compounds: cyclophosphamide, mechlorethamine, triethylene-melamine; psychiatric drugs: promazine and chlorpromazine, anesthetic agents and drugs: ketamine, morphine and morphine antagonists, pethidine, pancuronium.
","Suxamethonium has no effect on the level of consciousness and should not be administered to a patient who is notfullyanesthetized. Suxamethonium should not be administered to patients known to be hypersensitive to the drug. Suxamethonium is contraindicated in patients known to have an inherited atypical plasma cholinesterase activity. An acute transient rise in serum potassium often occurs following the administration of Suxamethonium in normal individuals (usually 0.5 mmol/Litre). But in certain pathological states it may cause excessive increase in serum potassium leading to serious cardiac arrhythmias and cardiac arrest. For this reason, use of Suxamethonium is contraindicated in patients recovering from major trauma, patients recovering from severe burns, patients with neurological deficits involving acute major muscle wasting and patients with pre-existing hyperkalemia. Suxamethonium causes a slight transient rise in intra-ocular pressure, and should therefore not be used in the presence of open eye injuries. The injection is contraindicated in new-born infants, especially in immature neonates.
","Cardiovascular: bradycardia, tachycardia, hypertension, hypotension, arrhythmias.
Respiratory: bronchospasm, prolonged respiratory depression and apnea.
Musculoskeletal: muscle fasciculation, post-operative muscle pains, myoglobinemia.
Others: hyperthermia, increased intra-ocular pressure increased intra-gastric pressure, rash, excessive salivation.
","Although Suxamethonium does not readily cross the placental barrier it should not be administered to pregnant women unless the potential benefit outweighs possible hazards.
","Suxamethonium should be administered only by or under close supervision of an anesthetist familiar with its action, characteristics and hazards, who is skilled in the management of artificial respiration and only where there are adequate facilities for immediate endotracheal intubation with administration of oxygen by intermittent positive pressure ventilation. The elderly may be more susceptible to cardiac arrhythmias, especially if digitalis-like drugs are also being taken.
",,,,,"Store in a refrigerator between 2°-8° C. Do not freeze.
",10
+1373,Suvorexant,suvorexant-1373,https://medex.com.bd/attachments/AmNgNCmDz7bXNWOToNLtxxvAqnzihm/suvorexant-prescribing-information,Miscellaneous sedatives & hypnotics,Insomnia and sleep disturbances,"Suvorexant is indicated for the treatment of insomnia, characterized by difculties with sleep onset and/or sleep maintenance.
","Miscellaneous sedatives & hypnotics
","Suvorexant is a highly selective antagonist for orexin receptors OX1R and OX2R. The mechanism by which Suvorexant exerts its therapeutic efect in insomnia is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system is a central promoter of wakefulness. Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive.
","Recommended dose is 10 mg, no more than once per night taken before 30 minutes of going to bed, with at least 7 hours remaining before the planned time of awakening. If the 10 mg dose is well-tolerated but not effective, the dose can be increased, not to exceed 20 mg once daily. Lowest dose effective should be used for the patient. Time to effect may be delayed if taken with or soon after a meal.
",,"CNS-Active Drugs: An additive effect on psychomotor performance was observed when a single dose of 40 mg of Suvorexant was co-administered with a single dose of 0.7 g/kg alcohol. Suvorexant does not afect alcohol concentrations and alcohol does not afect Suvorexant concentrations.
effect s of Other Drugs on Suvorexant: Strong (e.g., ketoconazole or itraconazole) and moderate (e.g., diltiazem) CYP3A inhibitors signifcantly increased Suvorexant exposure. Strong CYP3A inducers (e.g., rifampin) substantially decreases Suvorexant exposure.
effect s of Suvorexant on Other Drugs: Suvorexant is unlikely to cause clinically signifcant inhibition of human CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or CYP2D6. Chronic administration of Suvorexant is unlikely to induce the metabolism of drugs metabolized by major CYP isoforms.
","Do not use in patients with narcolepsy.
","Common side effects are Sleepiness during the day, Not thinking clearly, Act strangely, confused, or upset, Sleep-walking
","Pregnancy Category C. There is no adequate and well-controlled studies in pregnant women. Suvorexant should be used during pregnancy only if the potential beneft justifes the potential risk to the fetus.
","Daytime somnolence: Risk of impaired alertness and motor coordination, including impaired driving; risk increases with dose; caution patients taking 20 mg against next-day driving and other activities requiring complete mental alertness.
Need to evaluate for co-morbid diagnoses: Reevaluate if insomnia persists after 7 to 10 days of treatment.
",,,,,"Store in dry and cool place, protect from light & keep away from children.
",10
+1026,Super antioxidant [vitamins & minerals],super-antioxidant-vitamins-minerals-1026,,,,"This is indicated in the following cases:
+
+- To develop immune system.
+- To prevent the well known deficiency diseases such as scurvey, beriberi, pellagra and others.
+- Prevent certain types of cancer by blocking the formation of cancer causing substances in the body.
+- It is also capable of combating cardiovascular and immunological disorders.
+- To prevent aging.
+
",,"Vitamin A is essential for human health. Vitamin A is highly important for vision, cell development and immunity. Vitamin A's role on immunity contributes to its anti-cancer properties.
Vitamin C is one of the most widely taken supplements and plays a primary role in the formation of collagen, which is important for the growth and repair of cells, gums, blood vessels, bones and teeth. Thus vitamin C helps in faster recovery after surgery or any other trauma. Vitamin C quenches free radicals in the water based cellular components and thus acts as an antioxidant.
Vitamin E is a fat-soluble vitamin, which is stored in the liver, adipose tissues, heart, muscles etc. It is an active antioxidant, which prevents oxidation of fat compounds. It works in synergy with Selenium.
Vitamin K is a key anti-aging vitamin and it prevents heart disease and osteoporosis.
Zinc is an important mineral that can actually rejuvenate the shrinking thymus gland that involves the working of the immune system. Zinc is a co-factor in over 100 enzymes of the body.
Selenium: Apart from being a co-factor in antioxidant enzymes, Selenium by itself has potent antioxidant capabilities. So, it prevents aging and hardening of tissues through oxidation. Vitamin E and Selenium are synergistic and seem to potentiate each other's antioxidant activities.
Copper is an important co-factor of a number of enzymes present in our body. This enzymes act as endogenous antioxidant systems.
Manganese, an antioxidant, is one of the minerals required to form SOD (Super Oxide Dismutase). SOD is an enzyme that protect against cell damaging free radicals.
","The adult dose is 1 (one) tablet daily, or as prescribed by the physician.
",,,"This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
","Generally, this preparation is well-tolerated. Diarrhea may occasionally occur during treatment with beta carotene and the skin may assume a slightly yellow discoloration. The side-effects of vitamin A are reversible. Vitamin C and vitamin E may cause diarrhea and other gastrointestinal disturbances.
","This preparation is recommended in pregnancy and lactation
",,,"In case of accidental overdose, call a doctor or poison control center immediately.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",8
+1048,Sunitinib,sunitinib-1048,https://medex.com.bd/attachments/H9i62KSimyA73D6ihqxAEtqBbJ0wMN/sunitinib-prescribing-information,Targeted Cancer Therapy,Renal cell carcinoma,"Gastrointestinal Stromal Tumor (GIST): Sunitinib is indicated for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate.
Advanced Renal Cell Carcinoma (RCC): Sunitinib is indicated for the treatment ... Read more
Gastrointestinal Stromal Tumor (GIST): Sunitinib is indicated for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate.
Advanced Renal Cell Carcinoma (RCC): Sunitinib is indicated for the treatment of advanced renal cell carcinoma.
Advanced Pancreatic Neuroendocrine Tumors (pNET): Sunitinib is indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in patients with unresectable locally advanced or metastatic disease.
","Targeted Cancer Therapy
","Sunitinib inhibits cellular signaling by targeting multiple receptor tyrosine kinases (RTKs).
These include all receptors for platelet-derived growth factor (PDGF-Rs) and vascular endothelial growth factor receptors (VEGFRs), which play a role in both tumor angiogenesis and tumor cell proliferation. The simultaneous inhibition of these targets therefore reduces tumor vascularization and triggers cancer cell apoptosis and thus results in tumor shrinkage.
Sunitinib also inhibits CD117 (c-KIT), the receptor tyrosine kinase that (when improperly activated by mutation) drives the majority of gastrointestinal stromal cell tumors. It has been recommended as a second-line therapy for patients whose tumors develop mutations in c-KIT that make them resistant to imatinib, or who the cannot tolerate the drug.
In addition, sunitinib binds other receptors. These include: RET, CD114, CD135. The fact that sunitinib targets many different receptors, leads to many of its side effects such as the classic hand-foot syndrome, stomatitis, and other dermatologic toxicities.
","Recommended Dose For GIST And RCC: The recommended dose of Sunitinib for gastrointestinal stromal tumor (GIST) and advanced renal cell carcinoma (RCC) is one 50 mg oral dose taken once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2). Sunitinib may be taken with or without food.
Recommended Dose For pNET: The recommended dose of Sunitinib for pancreatic neuroendocrine tumors (pNET) is 37.5 mg taken orally once daily continuously without a scheduled off-treatment period. Sunitinib may be taken with or without food.
Dose Modification: Dose interruption and/or dose modification in 12.5 mg increments or decrements is recommended based on individual safety and tolerability. The maximum dose administered in the Phase 3 pNET study was 50 mg daily.
Strong CYP3A4 inhibitors such as ketoconazole may increas e sunitinib plasma concentrations. Selection of an alternate concomitant medication with no or minimal enzyme inhibition potential is recommended. A dose reduction for Sunitinib to a minimum of 37.5 mg (GIST and RCC) or 25 mg (pNET) daily should be considered if Sunitinib must be co-administered with a strong CYP3A4 inhibitor
CYP3A4 inducers such as rifampin may decreas e sunitinib plasma concentrations. Selection of an alternate concomitant medication with no or minimal enzyme induction potential is recommended. A dose increase for Sunitinib to a maximum of 87.5 mg (GIST and RCC) or 62.5 mg (pNET) daily should be considered if Sunitinib must be co-administered with a CYP3A4 inducer. If dose is increased, the patient should be monitored carefully for toxicity
",,"Increased plasma cone with strong CYP3A4 inhibitors (eg ketoconazole, ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice). Decreased plasma cone with strong CYP3A4 inducers [eg rifampin, dexamethasone, phenytoin, carbamazepine, phenobarb, St. John's wort (Hypericum perforatum)]. Anticoagulants eg warfarin, acenocoumarol (periodically monitor platelets, prothrombin time/INR & physical exam).
","Hypersensitivity, Renal impairment
","Fatigue, GI disorders, skin discoloration, rash, palmar-plantar erythrodysesthesia, dry skin, hair color changes, mucosal inflammation, asthenia, dysguesia, anorexia, HTN, neutropenia.
","Pregnancy Category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
",,,"Treatment of overdose with Sunitinib should consist of general supportive measures. There is no specific antidote for overdosage with Sunitinib. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage. Cases of accidental overdose have been reported; these cases were associated with adverse reactions consistent with the known safety profile of Sunitinib, or without adverse reactions. A case of intentional overdose involving the ingestion of 1,500 mg of Sunitinib in an attempted suicide was reported without adverse reaction. In non-clinical studies mortality was observed following as few as 5 daily doses of 500 mg/kg (3000 mg/m²) in rats. At this dose, signs of toxicity included impaired muscle coordination, head shakes, hypoactivity, ocular discharge, piloerection and gastrointestinal distress. Mortality and similar signs of toxicity were observed at lower doses when administered for longer durations.
",,,,9
+1025,Sumatriptan,sumatriptan-1025,https://medex.com.bd/attachments/gm57uRDggUvqygBkXGBO5wtnRdtAbm/sumatriptan-prescribing-information,5-HT Agonists,Migraine,"Sumatriptan is indicated for acute treatment of migraine with or without aura in adults.
Limitations of Use:
+
+- Use only if a clear diagnosis of migraine headache has been established.
+- Not indicated for the prophylactic therapy of migraine attacks.
+- Not indicated for the treatment of cluster headache.
+
","5-HT Agonists
","Sumatriptan Nasal Spray is an aqueous suspension of microfine Sumatriptan BP 10 mg for topical administration to the nasal mucosa by means of a metering, atomizing spray pump. Sumatriptan binds with high affinity to human cloned 5 HT1B/1D receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine headache through agonist effects at the 5 HT1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.
","Route of administration: Nasal
+
+- Single-dose of 10 mg of nasal spray.
+- The maximum dose in a 24 hour period: 30 mg; separate doses by at least one hour or as directed by the physician.
+
+Use in children and adolescents: Sumatriptan is not recommended for use in patients younger than 18 years of age.
","How to use the Nasal Spray-
+
+- Shake the bottle gently and remove the dust cover.
+- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
+- Gently blow the nose to clear the nostrils.
+- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
+- Breathe out through your mouth.
+- Repeat the above steps in the same/ other nostril for consecutive doses.
+
+Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-
+
+- Remove the dust cover.
+- Gently pull off the nasal applicator.
+- Wash the applicator and dust cover in warm water.
+- Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
+- Gently push the applicator back on the top of the bottle and re-fix the dust cover.
+
","With Medicine: Sumatriptan nasal spray is contraindicated with Ergot-Containing Drugs, Monoamine Oxidase-A Inhibitors, Other 5-HT1 Agonists and Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors.
With food and others: No interaction with foods.
","
+- History of coronary artery disease or coronary vasospasm
+- Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders
+- History of stroke, transient ischemic attack, or hemiplegic or basilar migraine
+- Peripheral vascular disease
+- Ischemic bowel disease
+- Uncontrolled hypertension
+- Recent (within 24 hours) use of another 5 HT1 agonist (e.g., another triptan) or of an ergotamine containing medication
+- Concurrent or recent (past 2 weeks) use of monoamine oxidase A inhibitor
+- Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen)
+- Severe hepatic impairment
+
","Common side effects: Unusual or unpleasant taste in the mouth; pain, burning, numbness, or tingling in the nose or throat; runny or stuffy nose after using the nasal medicine.
Rare side effects: Anxiety, burning sensation, discomfort of the nasal cavity and throat, general feeling of illness or tiredness & vision changes.
","There are no adequate and well-controlled studies in pregnant women and lactating mothers.
","
+- Myocardial ischemia/infarction and Prinzmetal’s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors
+- Arrhythmias: Discontinue Sumatriptan if occurs
+- Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally, not associated with Myocardial Ischemia; evaluate for coronary artery disease in patients at high risk
+- Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue Sumatriptan if occurs
+- Gastrointestinal ischemia and reactions, peripheral vasospastic reactions: Discontinue Sumatriptan if occurs
+- Medication overuse headache: Detoxification may be necessary
+- Serotonin syndrome: Discontinue Sumatriptan if occurs
+- Increase in blood pressure: Hypertensive crisis can occur
+- Hypersensitivity reactions: Angioedema and anaphylaxis can occur
+- Seizures: Use with caution in patients with epilepsy or a lowered seizure threshold
+- Local irritation: Burning and abnormal taste can occur
+
",,"No specific data is available on the overdose of Sumatriptan 10 mg nasal spray.
",,,"Store between 20°C-25°C temperature. Do not store in the refrigerator or freezer. Do not test before use
",12
+1047,Sulphonated Surfactant,sulphonated-surfactant-1047,,"Benzoyl peroxide, Azelaic acid & other preparations",Acne vulgaris,"Bar Cleanser for acne & greasy skin. Liquid cleanser Soap-free cleanser for acne prone and oily skin conditions.
","Benzoyl peroxide, Azelaic acid & other preparations
","Surfactants are compounds that lower the surface tension (or interfacial tension) between two liquids or between a liquid and a solid. Surfactants may act as detergents, wetting agents, emulsifiers, foaming agents, and dispersants.
A wetting agent is a surfactant that, when dissolved in water, lowers the advancing contact angle, aids in displacing an air phase at the surface, and replaces it with a liquid phase. Examples of application of wetting to pharmacy and medicine include the displacement of air from the surface of sulfur, charcoal, and other powders for the purpose of dispersing these drugs in liquid vehicles; the displacement of air from the matrix of cotton pads and bandages so that medicinal solutions can be absorbed for application to various body areas; the displacement of dirt and debris by the use of detergents in the washing of wounds; and the application of medicinal lotions and sprays to surface of skin and mucous membranes.
","Use on the face or other affected areas. Wash as with an ordinary soap and massage the creamy lather into the skin. Wet skin, apply & rinse off w/ water once or bid. Using warm water, gently rub the soap on the skin until a rich lather is formed. Massage briskly and rinse thoroughly.
This Liquid cleanser can be used both with water and without water for face. If the cleanser is used with water, apply liberal amount of cleanser to the skin. Massage gently in circular motion. Rinse with water. In case it is used without water, apply cleanser to the skin and massage gently in circular motion, remove excess with soft tissue or cotton wool.
",,"There are no known drug interactions and none well documented.
","Hypersensitivity.
","Mild irritation, skin sensitization
","Pregnancy Category- Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
","Avoid contact with eyes. Flush with water if lather enters the eyes.
",,,,,,9
+1055,Testosterone Undecanoate,testosterone-undecanoate-1055,https://medex.com.bd/attachments/V4tkCg9AKKBO3uqAfOF0fBIednWkEZ/testosterone-undecanoate-topical-gel-prescribing-information,Male Sex hormones (Androgens),Testosterone replacement therapy,"The active substance of this preparation is turned into testosterone by your body. Testosterone is the natural male hormone, necessary for the normal growth, development and function of the male sex organs and for secondary male sex characteristics. Preparations containing Testosterone are usually prescribed ... Read more
The active substance of this preparation is turned into testosterone by your body. Testosterone is the natural male hormone, necessary for the normal growth, development and function of the male sex organs and for secondary male sex characteristics. Preparations containing Testosterone are usually prescribed to replace the hormone if the body is unable to produce enough on its own. Testosterone are soft oval glossy capsules, transparent, orange-red colour, with an oily fill.
","Male Sex hormones (Androgens)
","Testosterone plays a key role in male sexual differentiation and is involved in regulation of hematopoiesis, body composition, and bone metabolism. As a result, testosterone replacement therapy in males with hypogonadism can result in improved sexual function, increased lean body mass, bone density, erythropoiesis, prostate size, and changes in lipid profiles.
Testosterone is produced by Leydig cells and exerts it's effects by binding to androgen receptors throughout the body. Testosterone affects the voice, genitalia, mood, and influences muscle growth and protein expression. Accordingly, males with low levels of testosterone often experience decreased libido, fatigue, mood changes and dysphoria. Exogenous sources of testosterone are designed to mimic the effects of endogenous testosterone.
","Usually, the dosage is 3-4 capsules daily during the first 2-3 weeks, followed by a gradual decrease to 1-3 capsules daily. You must take Testosterone with a meal. Swallow the capsules whole without chewing, using some water or other fluid. Take half of the daily dose in the morning and the other half in the evening. If the daily dose is an uneven number of capsules, take the larger number in the morning. If you have the impression that the effect of Testosterone is too strong or too weak, inform your doctor immediately.
","If you forget to take Testosterone, do not take a double dose to make up for the forgotten individual dose. When treatment with Testosterone is stopped, complaints as those before treatment may re-occur within a few weeks.
","Food allows Testosterone Undecanoate to be taken up by your body. Therefore, Testosterone must be taken with a meal. Other medicines may influence the effects of Testosterone or Testosterone may affect other medicines. You must tell your doctor or pharmacist if you are using (or intend to use) rifampicin (an antibiotic) or medicines for epilepsy or sleeplessness.
","Do not take Testosterone
+
+- If you have a tumour of the prostate or the breast.
+- If you are hypersensitive (allergic) to Testosterone Undecanoate or any of the other ingredients of Testosterone.
+
","In general:
+
+- increased sexual desire
+- fluid retention in the tissues, usually marked by swelling of ankles or feet
+
+In men:
+
+- prolonged abnormal, painful erection of the penis
+- disturbed formation of sperm
+- decreased amount of sperm with seminal discharge
+
+In elderly men:
+
+- problems with passing urine
+
+In young boys:
+
+- early sexual development
+- erections occurring more often than normal
+- enlarged penis
+- disturbed growth
+
+Tell your doctor as soon as possible if any side-effect becomes troublesome or continues.
",,"Extra supervision by a doctor is necessary in the treatment of young boys, since Testosterone suppletion may cause early sexual development and disturb growth. Extra supervision by a doctor is also necessary in the treatment of elderly men, since male hormones may increase the size of the prostate gland. Medical checks may also be necessary for some other conditions.
Therefore, tell your doctor if you have or have ever had:
+
+- heart disease
+- kidney disease
+- high blood pressure
+- epilepsy
+- migraine headaches
+- prostatic complaints, such as problems with passing urine.
+
",,"If you have taken several capsules at once, there is no need for great concern. However, you should consult your doctor. The oily substance in the capsule may cause diarrhoea.
",,,"Keep Testosterone out of reach and sight of children. Store at 8°C-30°C. Store in the original package in order to protect from light. Do not use Testosterone after the expiry date stated on the package, sachet and blister.
",11
+1074,Testosterone Decanoate,testosterone-decanoate-1074,,Male Sex hormones (Androgens),Testosterone replacement therapy,"Males: Testosterone is indicated for Testosterone replacement therapy for primary and secondary hypogonadal disorders, which include:
+
+- After castration
+- Eunuchoidism
+- Hypopituitarism
+- Endocrine impotence
+- Certain types of infertility due to spermatogenic disorders
... Read more
Males: Testosterone is indicated for Testosterone replacement therapy for primary and secondary hypogonadal disorders, which include:
+
+- After castration
+- Eunuchoidism
+- Hypopituitarism
+- Endocrine impotence
+- Certain types of infertility due to spermatogenic disorders
+- Male climacteric symptoms as decreased libido and decreased feeling of general wellbeing and fitness
+- Osteoporosis caused by androgen deficiency
+
+
Female to male transsexuals: Testosterone is indicated for masculinization.
","Male Sex hormones (Androgens)
","Testosterone is the principal endogenous hormone essential for normal growth and development of the male sex organs and male secondary sex characteristics. During adult life testosterone is essential for the functioning of the testes and accessory structures and for the maintenance of libido, sense of well-being, erectile potency, prostate and seminal vesicle function.
Treatment of hypogonadal men with Testanon results in a clinically significant rise of plasma concentrations of testosterone, dihydrotestosterone and androstenedione, as well as a decrease of SHBG (sex hormone binding globulin). In males with primary (hypergonadotropic) hypogonadism treatment with Testosterone Decanoate results in a normalization of gonadotropin levels. Treatment of female-to-male transsexuals with Testosterone Decanoate results in a clinically significant rise of plasma testosterone levels, a decrease of LH and FSH levels and a decrease in SHBG level.
","In general, the dose should be adjusted according to the response of the individual patient.
Adults: Usually, one injection of 1 ml per three weeks is adequate. Testosterone should be administered by deep intramuscular injection.
Children: Safety and efficacy have not been adequately determined in children and adolescents.
Testosterone contains benzyl alcohol and should not be given to children under 3 years of age.
",,"Enzyme inducing agents may exert increasing or decreasing effects on Testosterone levels. Therefore, adjustment of dose or intervals between injections may be required.
","Testosterone is contraindicated in case of known hypersensitivity to Testosterone or any of its components. It is also contraindicated in patient with known and suspected prostatic carcinoma or breast carcinoma in male.
","The most common side effects of Testosterone therapy are precocious sexual development, increased frequency of erections, phallic enlargement and premature epiphyseal closure, priapism, oligospermia, decreased ejaculatory volume and fluid & sodium retention.
","Pregnancy: There are no adequate data for the use of Testosterone in pregnant women. In view of the risk of virilization of the foetus, Testosterone should not be used during pregnancy. Treatment with Testosterone should be discontinued when pregnancy occurs.
Lactation: There are no adequate data for the use of Testosterone during lactation. Therefore, Testosterone should not be used during lactation.
","Androgens should be used with caution in pre (pubertal) boys to avoid premature epiphyseal closure or precocious sexual development. Skeletal maturation should be monitored regularly. Patients with latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine (or a history of these conditions) should be kept under close medical supervision, since aggravation or recurrence may occasionally be induced. Androgens should be used with caution in men suffering from benign prostatic hyperplasia. The use of steroids may influence the results of certain laboratory tests. The misuse of androgens to enhance ability in sports carries serious health risks and is to be discouraged.
",,"The acute intramuscular toxicity of Testosterone is very low. Priapism in men is a symptom of chronic over dosage. If this occurs, treatment should be interrupted and after disappearance of the symptom, be resumed at a lower dosage.
",,,"Store in a cool (between 8º C to 30º C) and dry place protected from light. Keep out of the reach of children.
",11
+1793,Terlipressin Acetate,terlipressin-acetate-1793,https://medex.com.bd/attachments/sPxQ52GZf8WvVC7dtFZxKLDkPvtftW/terlipressin-acetate-prescribing-information,Other preparations,Bleeding or blood clotting problems,"For use in the short term management of bleeding oesophageal varices. ""Emergency treatment of type 1 hepatorenal syndrome, as defined by IAC (International Ascites Club) criteria"".
","Other preparations
",,"Short term management of bleeding oesophageal varices: Initially an i.v. injection of 2 mg (2x8.5 ml) terlipressin acetate is given every 4 hours. The treatment should be maintained until bleeding has been controlled for 24 hours, but up to a maximum of 48 hours. After the initial dose, the dose can be adjusted to 1 mg (8.5 ml) terlipressin acetate i.v. every 4 hours in patients with body weight <50 kg or if adverse effects
occur.
In type 1 hepatorenal syndrome: An i.v. injection 3 to 4 mg (3x8.5ml to 4x8.5ml) terlipressin acetate every 24 hours as 3 or 4 administrations. In the absence of any reduction of the serum creatinine after 3 days of treatment, cessation of Terlipressin Acetate treatment is advised. In other cases, Terlipressin Acetate treatment is to be pursued until the obtaining either of a serum creatinine less than 130 µmol/litre or of a drop of at least 30% in the serum creatinine with respect to the value measured at the time of diagnosis of hepatorenal syndrome. The standard average duration of treatment is 10 days.
",,"The hypotensive effect of non-selective beta-blockers on the portal vein is increased with terlipressin. Concomitant treatment with medicinal products with a known bradycardiac effect (e.g. propofol, sufentanil) may lower the heart rate and cardiac output. These effects are due to reflexofenic inhibition of the cardiac activity via the vagus nerve due to elevated blood pressure. Terlipressin can trigger ""torsade de pointes"". Therefore, extreme caution should be exercised in the use of terlipressin in patients with concomitant medications that can prolong the QT interval, such as class IA and III antiarrhythmics, erythromycin, certain antihistamines and tricyclic antidepressants or medications that may cause hypokalaemia or hypomagnesemia (e.g. some diuretics).
","Hypersensitivity to the active substance or to any of the excipients of this preparation. Contraindicated in pregnancy.
","The most frequently reported undesired effects in clinical trials are paleness, increased blood pressure, abdominal pain, nausea, diarrhoea, and headache.
","Treatment with Terlipressin Acetate during pregnancy is contraindicated. Terlipressin Acetate has been shown to cause uterine contractions and increased intrauterine pressure in early pregnancy and may decrease the uterine blood flow. Terlipressin Acetate may have harmful effects on pregnancy and foetus. Spontaneous abortion and malformation of the foetus have been shown in rabbits after treatment with Terlipressin Acetate.
It is not known whether Terlipressin Acetate is excreted in human breast milk. The excretion of Terlipressin Acetate in milk has not been studied in animals. A risk to the suckling child cannot be excluded. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Terlipressin Acetate should be made taking into account the benefit of breast-feeding to the child and the benefit of Terlipressin Acetate therapy to the woman.
","Cardiac, pulmonary and vascular disease: During treatment regular monitoring and control of blood pressure, ECG, heart rate, serum levels of sodium and potassium, as well as fluid balance are required. Caution should be exercised in treating patients with hypertension, recognised heart disease, renal dysfunction, cerebral or peripheral vascular disease, asthma or respiratory failure.
Septic shock: In patients with septic shock with a low cardiac output terlipressin should not be used.
Injection site reaction: To avoid local necrosis at the injection site, the injection must be administered intravenously.
Torsade de pointes: During clinical trials and post-marketing experience, several cases of QT interval prolongation and ventricular arrhythmias including “Torsade de pointes” have been reported. In most cases, patients had predisposing factors such as basal prolongation of the QT interval, electrolyte abnormalities (hypokalemia, hypomagnesemia) or medications with concomitant effect on QT prolongation. Therefore, extreme caution should be exercised in the use of terlipressin in patients with a history of QT interval prolongation, electrolyte abnormalities, or concomitant medications that can prolong the QT interval.
Prior to use of terlipressin for hepatorenal syndrome, it must be ascertained that the patient has an acute functional renal failure and this functional renal failure does not respond to a suitable plasma expansion therapy.
Paediatric population and elderly patients: Particular caution should be exercised in the treatment of children and elderly patients, as experience is limited in these groups. There is no data available regarding dosage recommendation in these special patient categories.
Excipients: This medicinal product contains 1.33 mmol (30.7 mg) of sodium per ampoule, equivalent to 1.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
","Elderly patients: There is no data available regarding dosage recommendation in the elderly.
Paediatric population: There is no data available regarding dosage recommendation in the paediatric population.
","The recommended dose in the specific patient population should not be exceeded as the risk of severe circulatory adverse effects is dose-dependent. Elevated blood pressure in patients with recognised hypertension can be controlled with 150 mcg clonidine i.v. Bradycardia requiring treatment should be treated with atropine.
",,,"Store in a refrigerator (2-8°C). Keep the ampoules in the outer carton in order to protect from light.
",11
+1632,Teriparatide,teriparatide-1632,https://medex.com.bd/attachments/vjMITz1uQHDS31soBdYEliHw9WGmdN/teriparatide-prescribing-information,Thyroid drugs & hormone,Osteoporosis,"Teriparatide is a parathyroid hormone analog, (PTH 1-34), indicated for:
+
+- Treatment of postmenopausal women with osteoporosis at high risk for fracture.
+- Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture.
+- Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture.
+
","Thyroid drugs & hormone
","Endogenous 84-amino acid parathyroid hormone (PTH) is the primary regulator of calcium and phosphate metabolism in bone and kidney. Physiological actions of PTH include regulation of bone metabolism, renal tubular reabsorption of calcium and phosphate, and intestinal calcium absorption. The biological actions of PTH and teriparatide are mediated through binding to specific high-affinity cell-surface receptors. Teriparatide and the 34 N-terminal amino acids of PTH bind to these receptors with the same affinity and have the same physiological actions on bone and kidney. Teriparatide is not expected to accumulate in bone or other tissues. The skeletal effects of teriparatide depend upon the pattern of systemic exposure. Once-daily administration of teriparatide stimulates new bone formation on trabecular and cortical (periosteal and/or endosteal) bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity. In monkey studies, teriparatide improved trabecular microarchitecture and increased bone mass and strength by stimulating new bone formation in both cancellous and cortical bone. In humans, the anabolic effects of teriparatide manifest as an increase in skeletal mass, an increase in markers of bone formation and resorption, and an increase in bone strength. By contrast, continuous excess of endogenous PTH, as occurs in hyperparathyroidism, may be detrimental to the skeleton because bone resorption may be stimulated more than bone formation.
","
+- Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture: The recommended dose is 20 mcg subcutaneously once a day.
+- Increase of Bone Mass in Men with Primary or Hypogonadal Osteoporosis at High Risk for Fracture: The recommended dose is 20 mcg subcutaneously once a day.
+- Treatment of Men and Women with Glucocorticoid-Induced Osteoporosis at High Risk for Fracture: The recommended dose is 20 mcg subcutaneously once a day.
+
","
+- Teriparatide should be administered as a subcutaneous injection into the thigh or abdominal wall. There are no data available on the safety or efficacy of intravenous or intramuscular injection of Teriparatide.
+- Teriparatide should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur
+- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Teriparatide is a clear and colorless liquid. Do not use if solid particles appear or if the solution is cloudy or colored.
+- Patients and caregivers who administer Teriparatide should receive appropriate training and instruction on the proper use of the Teriparatide delivery device from a qualified health professional
+
","Digoxin: A single Teriparatide dose did not alter the effect of digoxin on the systolic time interval (from electrocardiographic Q-wave onset to aortic valve closure, a measure of digoxin’s calcium-mediated cardiac effect). However, because Teriparatide may transiently increase serum calcium, Teriparatide should be used with caution in patients taking digoxin
Hydrochlorothiazide: The coadministration of hydrochlorothiazide 25 mg with teriparatide did not affect the serum calcium response to teriparatide 40 mcg. The effect of coadministration of a higher dose of hydrochlorothiazide with teriparatide on serum calcium levels has not been studied
Furosemide: Coadministration of intravenous furosemide (20 to 100 mg) with teriparatide 40 mcg in healthy people and patients with mild, moderate, or severe renal impairment (CrCl 13 to 72 mL/min) resulted in small increases in the serum calcium (2%) and 24-hour urine calcium (37%) responses to teriparatide that did not appear to be clinically important
","Do not use Teriparatide in patients with hypersensitivity to teriparatide or to any of its excipients. Reactions have included angioedema and anaphylaxis.
","Most common adverse reactions include: arthralgia, pain, and nausea.
","There are no available data on Teriparatide use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Consider discontinuing Teriparatide when pregnancy is recognized. It is not known whether teriparatide is excreted in human milk, affects human milk production, or has effects on the breastfed infant.
","
+- Patients with Paget’s disease of bone, pediatric and young adult patients with open epiphyses, and patients with prior external beam or implant radiation involving the skeleton: Should not be treated with Teriparatide
+- Treatment duration: Use of Teriparatide for more than 2 years during a patient’s lifetime is not recommended.
+- Patients with bone metastases, history of skeletal malignancies, metabolic bone diseases other than osteoporosis, or hypercalcemic disorders: Should not be treated with Teriparatide
+- Laboratory alterations: Teriparatide may increase serum calcium, urinary calcium, and serum uric acid
+- Urolithiasis: Use with caution in patients with active or recent urolithiasis because of risk of exacerbation
+- Orthostatic hypotension: Transient orthostatic hypotension may occur with initial doses of Teriparatide.
+
","
+- Pediatric Use: The safety and efficacy of Teriparatide have not been established in any pediatric population.
+- Hepatic Impairment: No studies have been performed in patients with hepatic impairment.
+
",,,,"The Teriparatide delivery device should be stored under refrigeration at 2 to 8°C at all times. Do not freeze. Do not use Teriparatide if it has been frozen.
",12
+1054,Terfenadine,terfenadine-1054,,Non-sedating antihistamines,Allergic conditions,"Terfenadine is indicated for the treatment of allergic rhinitis, hay fever, and allergic skin disorders.
","Non-sedating antihistamines
","Terfenadine competes with histamine for binding at H1-receptor sites in the GI tract, uterus, large blood vessels, and bronchial muscle. This reversible binding of terfenadine to H1-receptors suppresses the formation of edema, flare, and pruritus resulting from histaminic activity. As the drug does not readily cross the blood-brain barrier, CNS depression is minimal.
","Adult (>12 year and >50 kg): 60-120 mg in the morning or 60 mg bid. Max: 120 mg daily.
Renal Impairment: CrCl <40: Half the usual daily dose
",,"Increased risk of ventricular arrhythmia with triazole and imidazole antifungals, macrolide antibacterials, streptogramin antibacterials, SSRI, HIV-protease inhibitors and non-nucleoside reverse transcriptase inhibitors, arrhythmogenic drugs, diuretics, astemizole and zileutron.
","Porphyria.
","Anxiety, palpitations, insomnia, mild GI distubances, erythema multiforme and galactorrhoea.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Child and elderly. Avoid in patients with cardiac or significant hepatic disease, electrolyte imbalance, or known or suspected prolongation of the QT interval. Lactation, pregnancy.
",,,,,,9
+1256,Terconazole,terconazole-1256,https://medex.com.bd/attachments/I1VSD5aQHcZ5Et92qibze7HHrpnfJw/terconazole-prescribing-information,Drugs used in Vaginal and Vulval condition,Vulvovaginal candidiasis,"Terconazole Vaginal Cream and Vaginal Suppositories are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As these products are effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.
","Drugs used in Vaginal and Vulval condition
","Terconazole disrupts ergosterol synthesis by binding to fungal cytochrome P450. It is active in vitro against Candida spp. and other fungi. It has some antibacterial activity in vitro but not against usual vag flora e.g, lactobacilli.
","Terconazole Vaginal Cream 0.4%: One full applicator (5 g) of 7 Vaginal Cream (20 mg terconazole) should be administered intravaginally once daily at bedtime for seven consecutive days.
Terconazole Vaginal Cream 0.8%: One full applicator (5 g) of Vaginal Cream (40 mg terconazole) should be administered intravaginally once daily at bedtime for three consecutive days.
Terconazole Vaginal Suppositories 80 mg: One Vaginal Suppository (80 mg terconazole) should be administered intravaginally once daily at bedtime for three consecutive days.
Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures and other pathogens commonly associated with vulvovaginitis ruled out. The therapeutic effect of these products is not affected by menstruation.
",,"May decrease absorption of ciprofloxacin, ciclosporin, mycophenolate, tacrolimus and levothyroxine. Sevelamer should be given 3 hr before or 1 hr after taking other drugs to minimise potential pharmacokinetic interaction.
","Patients known to be hypersensitive to terconazole or to any of the components of the cream or suppositories.
","Vulvovaginal burning, vulvar itching, dysmenorrhoea, genital, body and abdominal pain. Flu-like syndrome with headache, fever, chills and hypotension with doses >80 mg.
","Pregnancy Category C. There was no evidence of teratogenicity when terconazole was administered orally up to 40 mg/kg/day (25x the recommended intravaginal human dose of the suppository formulation, 50x the recommended intravaginal human dose of the 0.8% vaginal cream formulation, and 100x the intravaginal human dose of the 0.4% vaginal cream formulation) in rats, or 20 mg/kg/day in rabbits, or subcutaneously up to 20 mg/kg/day in rats.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Animal studies have shown that rat offspring exposed via the milk of treated (40 mg/kg/orally) dams showed decreased survival during the first few post-partum days, but overall pup weight and weight gain were comparable to or greater than controls throughout lactation. Because many drugs are excreted in human milk, and because of the potential for adverse reaction in nursing infants from terconazole, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","Discontinue use and do not retreat with terconazole if sensitization, irritation, fever, chills or flu-like symptoms are reported during use. The base contained in the suppository formulation may interact with certain rubber or latex products, such as those used in vaginal contraceptive diaphragms; therefore concurrent use is not recommended.
","Pediatric Use: Safety and efficacy in children have not been established.
Geriatric Use: Clinical studies of terconazole did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
","Overdose of terconazole in humans has not been reported to date. In the rat, the oral LD 50 values were found to be 1741 and 849 mg/kg for the male and female, respectively. The oral LD 50 values for the male and female dog were @ 1280 and ≥ 640 mg/kg, respectively.
",,,"Store at Controlled Room Temperature 15–30°C
",12
+1053,Terbutaline Sulfate,terbutaline-sulfate-1053,https://medex.com.bd/attachments/PcVpewzKxCcrBCWrH1WjxzfnN9szpm/terbutaline-sulfate-prescribing-information,Short-acting selective & β2-adrenoceptor stimulants,Uncomplicated premature labour,"Terbutaline sulfate is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.
","Short-acting selective & β2-adrenoceptor stimulants
","Terbutaline is a relatively selective β2-adrenergic bronchodilator that has little or no effect on alpha-adrenergic receptors. The drug has exerts a preferential effect on β2-adrenergic receptors but stimulates beta-adrenergic receptors less selectively than relatively selective β2-agonists. Terbutaline appears to have a greater stimulating effect on beta-receptors of the bronchial, vascular, and uterine smooth muscles (β2 receptors) than on the beta-receptors of the heart (β1 receptors). This drug relaxes smooth muscle and inhibits uterine contractions, but may also cause some cardiostimulatory effects and CNS stimulation.
The pharmacologic effects of terbutaline are at least in part attributable to stimulation through beta-adrenergic receptors of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic- 3',5'- adenosine monophosphate (c-AMP). Increased c-AMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
","Use in bronchospasm: Terbutaline tablets and syrup have a duration of action of 7 to 8 hours. The minimum recommended dosage interval is therefore 7 hours.
Adults/Elderly:
+
+- Tablets: During the first 1-2 weeks 2.5 mg (1 tablet) 3 times in a 24 hour period is recommended. The dose may then be increased to 5 mg (2 tablets) 3 times in 24 hours to achieve adequate bronchodilation.
+- Syrup: The starting dose should be 2×5 ml spoonfuls (3 mg) 3 times in 24 hours. The dose may then be increased to 3×5 ml spoonfuls (4.5 mg) 3 times in 24 hours if necessary.
+
+Children:
+
+- Tablets: 7-15 years, the starting dose should normally be 2.5 mg (1 tablet) 2 times in 24 hours. However, in some patients, the dose may need to be increased to 2.5 mg (1 tablet) 3 times in 24 hours.
+- Syrup: 0.25 ml (0.075 mg)/kg body weight 3 times in a 24 hour period.
+
",,"β-blocking agents, especially the non-selective ones such as propranolol may partially or totally inhibit the effect of β-stimulants. Therefore Terbutaline preparations and non-selective β-blockers should not normally be administered concurrently. Terbutaline should be used with caution in patients receiving other sympathomimetics.
","Patients with known hypersensitivity to Terbutaline.
","The frequency of side-effects is low at the recommended doses. Side-effects which have been recorded such as tremor, headache, tonic cramp and palpitations are all characteristic of sympathomimetic amines. A few patients feel tense; this is also due to the effects on skeletal muscle and not to direct CNS stimulation. Whenever these side-effects have occurred the majority have usually been spontaneously reversible within the first week of treatment. Urticaria and exanthema may occur. In children sleep disturbances and disturbances of behavioural effects have been observed. Potentially serious hypokalaemia may result from β2-agonist therapy.
","Although no teratogenic effects have been observed in animals or in patients, Terbutaline should only be administered with caution during the first trimester of pregnancy. Terbutaline is secreted via breast milk, but effect on the infant is unlikely at therapeutic doses.
","Care should be taken with patients suffering from myocardial insufficiency or thyrotoxicosis. Due to the hyperglycaemic effects of β2-stimulants, additional blood glucose measurements are initially recommended when Terbutaline therapy is commenced in diabetic patients. If a previously effective dosage regimen no longer gives the same symptomatic relief the patient should seek further medical advice, for reassessment of asthma therapy, as soon as possible. Potentially serious hypokalaemia may result from β2-agonist therapy. Particular caution is advised in severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended that serum potassium levels are monitored in such situations. Due to the positive inotropic effect of β2-agonists, these drugs should not be used in patients with hypertophic cardiomyopathy.
",,"Possible symptoms: Headache, anxiety, tremor, tonic cramp, palpitations, arrhythmia. A fall in blood pressure sometimes occurs.
Treatment:
+
+- Mild and moderate cases: Reduce the dose.
+- Severe cases: Gastric lavage, administration of activated charcoal.
+
",,,"Store in a cool and dry place, protected from light.
",11
+1052,Terbinafine Hydrochloride,terbinafine-hydrochloride-1052,https://medex.com.bd/attachments/3lym41VOK32piKpC3AhyNIqVRY7KWd/terbinafine-hydrochloride-cream-prescribing-information,Other Antifungal preparations,,"Terbinafine tablet: This tablet is indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).
Terbinafine granules: This is indicated in Tinea Capitis.
Terbinafine cream: Fungal ... Read more
Terbinafine tablet: This tablet is indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).
Terbinafine granules: This is indicated in Tinea Capitis.
Terbinafine cream: Fungal infection of the skin caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. Yeast infections of the skin, principally those caused by the genus Candida (e.g. C. albicans). Pityriasis (tinea) versicolor due to Pityrosporum orbicular (also known as Malassezia furfur).
Terbinafine 1% Spray: This spray is indicated in the treatment of tinea infections of the skin. This spray is also indicated in the treatment of pityriasis (tinea) versicolor due to Malassezia furfur.
","Other Antifungal preparations, Topical Antifungal preparations
","Terbinafine, an Allylamine antifungal, inhibits biosynthesis of Ergosterol (an essential component of fungai cell membrane) via inhibition of Squalene Epoxidase enzyme. This results in fungal cell death primarily due to the increased membrane permeability mediated by the accumulation of high concentrations of Squalene but not due to Ergosterol deficiency. Depending on the concentration of the drug and the fungal species test in vitro, Terbinafine hydrochloride may be fungicidal. However, the clinical significance of in vitro data is unknown. Terbinafine has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections: Tricophyton Mentagrophyte, Trichophyton Rubrum.
","Terbinafine tablet:
+
+- For the treatment of fingernail onychomycosis: Terbinafine 250 mg (one tablet), once daily for 6 weeks.
+- For the treatment of toenail onychomycosis: Terbinafine 250 mg (one tablet), once daily for 12 weeks.
+- The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for the outgrowth of healthy nail.
+
+
Terbinafine granules:
+
+- Body Weight: <25 kg: 125 mg/day up to 6 weeks
+- Body Weight: 25-35 kg: 187.5 mg/day up to 6 weeks
+- Body Weight: >35 kg: 250 mg/day up to 6 weeks
+
+
Terbinafine cream: Terbinafine cream can be applied once or twice daily. Cleanse and dry the affected areas thoroughly before application of the terbinafine cream. Apply the cream to the affected skin and the surrounding area in a thin layer and rub in lightly. In the case of intertriginous infections (submammary, interdigital, intergluteal, inguinal) the application may be covered with a gauze strip, especially at night. The likely durations of treatment are as follows:
+
+- Tinea corporis, cruris: 1 to 2 weeks
+- Tinea pedis: 1 week
+- Cutaneous candidiasis: 2 weeks
+- Pityriasis versicolor: 2 weeks
+
+Relief of the clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks, the diagnosis should be verified.
Terbinafine 1% Spray: This spray is applied once or twice daily, depending on the indication. The affected areas should be cleansed and dried thoroughly before application of this spray. A sufficient amount of solution should be applied to wet the treatment area(s) thoroughly.
+
+- Tinea pedis: once a day,1 week
+- Tinea corporis/cruris: once a day,1 week
+- Pityriasis versicolor: twice a day, 1 week
+
+Relief of clinical symptoms usually occurs within a few days. If there are no signs of improvement after two weeks the diagnosis should be verified.
",,"In vivo studies have shown that terbinafine is an inhibitor of the CYP450 2D6 isozyme. Drugs predominantly metabolized by the CYP450 2D6 isozyme include the following drug classes: tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers, antiarrhythmics class 1C (e.g., flecainide and propafenone) and monoamine oxidase inhibitors Type B. Co-administration of terbinafine should be done with careful monitoring and may require a reduction in dose of the 2D6-metabolized drug.
","Terbinafine tablet and cream are contra-indicated in individuals with hypersensitive to terbinafine.
","The adverse events reported encompass gastrointestinal symptoms (including diarrhea, dyspepsia and abdominal pain), liver test abnormalities, rashes, urticaria, pruritus, and taste disturbances. In general, the adverse events were mild, transient, and did not lead to discontinuation. Adverse events, based on worldwide experience with terbinafine use, include: idiosyncratic and symptomatic hepatic injury and more rarely, cases of liver failure, some leading to death or liver transplant, serious skin reactions, severe neutropenia, thrombocytopenia, angioedema and allergic reactions (including anaphylaxis). Other adverse reactions that have been reported include malaise, fatigue, vomiting, arthralgia, myalgia, and hair loss.
","Terbinafine tablet: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that terbinafine not be initiated during pregnancy. After oral administration, terbinafine is present in the breast milk of nursing mothers. Treatment with terbinafine is not recommended in nursing mothers.
Terbinafine cream: Foetal toxicity and fertility studies in animals suggest no adverse effects. There is no clinical experience with terbinafine in pregnant women; therefore, unless the potential benefits outweigh any potential risk, terbinafine should not be administered. Terbinafine is excreted in breast milk and therefore mothers should not receive terbinafine treatment whilst breast-feeding.
","Warnings-
+
+- Terbinafine tablets: Rare cases of liver failure, some leading to death or liver transplant, have occurred with the use of terbinafine tablets for the treatment of onychomycosis in individuals with and without preexisting liver disease. In the majority of liver cases reported in association with terbinafine use, the patients had serious underlying systemic conditions and an uncertain causal association with terbinafine. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease. Treatment with terbinafine tablets should be discontinued if there is biochemical or clinical evidence of liver injury. There have been isolated reports of serious skin reaction (e.g., Stevens-Johnson Syndrome and toxic epidermal necrolysis). If progressive skin rash occurs, treatment with terbinafine should be discontinued.
+- Terbinafine cream: Terbinafine cream is for external use only. Contact with the eyes should be avoided.
+
+
Precautions: Terbinafine are not recommended for patients with chronic or active liver disease. Before prescribing Terbinafine, pre-existing liver disease should be assessed. Hepatotoxicity may occur in patients with and without pre-existing liver disease. Pretreatment serum transaminase (ALT and AST) teste are advised for all patients before taking terbinafine tablets.
","Pediatric use: The safety and efficacy of terbinafine have not been established in pediatric patients.
Use in the elderly: There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients.
","Clinical experience regarding overdose with terbinafine tablets is limited. Doses up to 5 gm (20 times the therapeutic daily dose) have been taken without inducing serious adverse reactions. The symptoms of overdose included nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache.
",,,"Store in a cool and dry place, below 30°C, protect from light.
",12
+1051,Terazosin Hydrochloride,terazosin-hydrochloride-1051,https://medex.com.bd/attachments/Lnh4h6qYvjf41LO4tjFRF5B8tDGh9p/terazosin-hydrochloride-prescribing-information,Alpha adrenoceptor blocking drugs,Hypertension,"Terazosin Hydrochloride is indicated in-
+
+- Single therapy is used to relieve from signs and symptoms of benign prostatic hyperplasia (BPH).
+- For the treatment of hypertension.
+
","Alpha adrenoceptor blocking drugs, BPH/ Urinary retention/ Urinary incontinence
","Terazosin is selective for alpha-1-adrenoceptors but not their individual subtypes. Inhibition of these alpha-1-adrenoceptors results in relaxation of smooth muscle in blood vessels and the prostate, lowering blood pressure and improving urinary flow. Smooth muscle cells accounts for roughly 40% of the volume of the prostate and so their relaxation reduces pressure on the urethra.
It has also been shown that catecholamines induce factors responsible for mitogenesis and alpha-1-adrenergic receptor blockers inhibit this effect. A final long term mechanism of terazosin and other alpha-1-adrenergic receptor blockers is the induction of apoptosis of prostate cells. Treatment with terazosin enhances the expression of transforming growth factor beta-1 (TGF-beta1), which upregulates p27kip1, and the caspase cascade
","Benign Prostatic Hyperplasia-
+
+- Initial dose: 1 mg at bedtime is starting dose of all patients and this dose should not be exceeded.
+- Subsequent dose: The dose slowly increases to achieve the desired response. The usual recommended dose range is 5-10 mg administered once a day.
+
+Hypertension-
+
+- Initial dose: 1 mg at bedtime is starting dose of all patients and this dose should not be exceeded.
+- Subsequent dose: The dose slowly increases to achieve the desired response. The usual recommended dose range is 2-10 mg administered once a day.
+
",,"
+- In patients receiving Terazosin plus ACE inhibitors or diuretics the proportion reporting dizziness or related side effects was greater than in the total population of Terazosin treated patients from clinical trials.
+- Terazosin has been given without interaction with analgesics/anti-inflammatory, cardiac glycosides, hypoglycemic, antiarrhythmic, anxiolytics/sedatives, antibacterial, hormones/steroids and drugs used for gout.
+
","Terazosin is contraindicated in patients known to be hypersensitive to Terazosin or its analogues.
","Postural hypotension is more commonly reported side effect. Dizziness, lack of energy, peripheral oedema; urinary frequency and priapism reported.
","The safety of Terazosin during pregnancy has not been established. So Terazosin is not recommended during pregnancy unless the potential benefit justifies the potential risk to mother and fetus. It is not known whether Terazosin is excreted in breast milk. As many drugs are excreted in breast milk, caution should be exercised when Terazosin is administered to a nursing mother.
","
+- First dose may cause hypotension (within 30-90 minutes). Therefore should be taken on retiring to bed.
+- Caution should be observed when Terazosin is administered with other antihypertensive agents, avoid the possibility of significant hypotension. When adding Terazosin to a diuretic or other antihypertensive agent, dosage reduction and retitration may be necessary.
+- The patients should be cautioned to avoid situation such as driving and hazardous tasks where injury could result due to syncope after initiation of Terazosin therapy.
+
",,"Acute overdose may lead to acute hypotension, cardiovascular support is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in a supine position. At the same time expansion of plasma volume and noradrenergic vasopressor may also be needed.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+1041,Tenoxicam,tenoxicam-1041,,Drugs for Osteoarthritis,Pain and inflammation associated with musculoskeletal and joint disorders,"Tenoxicam is indicated for the symptomatic treatment of the following painful inflammatory and degenerative disorders of the musculoskeletal system:
+
+- Rheumatoid arthritis.
+- Osteoarthritis.
+- Arthrosis.
+- Ankylosing spondylitis.
+- Extra-articular disorders, e.g. tendinitis, bursitis, periarthritis of the shoulders (shoulder-hand syndrome) or hips, strains, and sprains.
+- Acute gout.
+
","Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
","Tenoxicam is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic properties and it also inhibits platelet aggregation. Tenoxicam inhibits prostaglandin biosynthesis. In-vitro tests of leukocyte peroxidase suggest that tenoxicam may act as a scavenger for active oxygen at the site of inflammation. Tenoxicam is a potent in-vitro inhibitor of human metalloproteinases (stromelysin and collagenase), which induce cartilage breakdown. These pharmacological effects explain, at least in part, the therapeutic benefit of Tenoxicam in the treatment of painful inflammatory and degenerative disorders of the musculoskeletal system. Tenoxicam showed no mutagenic, carcinogenic or teratogenic effects in animals. As with other prostaglandin inhibitors, renal and gastrointestinal effects, increased incidence of dystocia and delayed parturition were observed in animal safety studies.
","Standard dosage: For all indications except acute gout, a daily dosage of 20 mg should be given at the same time of day.
In acute attacks of gout: The recommended dose for acute attacks of gout is 40 mg once daily for two days followed by 20 mg once daily for a further five days.
In the treatment of chronic disorders: The therapeutic effect of tenoxicam is evident early in treatment but there is a progressive increase in response over time. In chronic disorders, daily doses higher than 20 mg should be avoided since this would increase the frequency and intensity of unwanted reactions without significantly increasing efficacy. For patients needing long-term treatment, a reduction to a daily oral dose of 10 mg may be tried for maintenance.
Special dosage instructions: In principle, the above dosage recommendations also apply to elderly patients and to patients suffering from kidney or liver disease. Because of lack of clinical experience, no dosage recommendations have so far been established for children and adolescents.
","The tablets should be taken with a glass of water. It is preferable to take this medicine during or immediately after a meal.
","As in the case of other NSAIDs, salicylate displaces tenoxicam from protein-binding sites and increases clearance and volume of distribution of tenoxicam. Concurrent treatment with salicylate or other NSAIDs should be avoided because of increased risk of gastrointestinal undesirable reactions. The co-administration of some NSAIDs and methotrexate has been associated with reduced renal tubular secretion of methotrexate, higher plasma concentrations of methotrexate, and severe methotrexate toxicity. Therefore, caution should be exercised when Tenoxicam is administered concurrently with methotrexate. No clinically relevant interaction was found in the small number of patients receiving concomitant treatment with gold, penicillamine or probenecid. As Tenoxicam may decrease the renal clearance of lithium, their concomitant administration may lead to increased plasma levels and toxicity of lithium. The plasma levels of lithium should be closely monitored. As with NSAIDs in general, Tenoxicam should not be administered concurrently with K-sparing diuretics. There is a known interaction between these two classes of compounds, which may cause hyperkalemia and renal failure. No clinically significant interaction between Tenoxicam and furosemide was noted, but Tenoxicam attenuates the blood pressure-lowering effect of hydrochlorothiazide. As known from other NSAIDs, Tenoxicam might attenuate the antihypertensive effects of alpha-adrenergic blockers and ACE-inhibitors. No interactions have been reported between NSAIDs and centrally-acting alpha agonists or calcium channel blockers. There was no clinically relevant interaction when Tenoxicam was administered together with atenolol. During clinical trials no interaction was reported for patients treated concomitantly with digitalis products. Thus concurrent dosing of Tenoxicam and digoxin appears to be without major risk. No interaction has been found with concomitantly administered antacids, cimetidine, warfarin and phenprocoumon at the recommended dosages. The clinical effect of oral antidiabetic drugs (glibornuride, glibenclamide, tolbutamide) was likewise not modified by Tenoxicam. Nevertheless, careful monitoring is recommended when patients concomitantly receive anticoagulants or oral antidiabetic drugs. No clinically relevant interaction has been found between Tenoxicam and low molecular weight heparin.
","Tenoxicam must not be administered to patients:
+
+- known to be hypersensitive to the drug;
+- in whom salicylates or other non-steroidal anti-inflammatory drugs (NSAIDs) induce symptoms of asthma, rhinitis, or urticaria;
+- suffering or having suffered from the disease of the upper gastrointestinal tract, such as gastritis, gastric and duodenal ulcer.
+
","Based on clinical trials including large numbers of patients, Tenoxicam proved to be well tolerated in the recommended dose. Usually, the undesirable effects reported were mild and transient. In a small proportion of patients, the interruption of treatment due to undesirable effects was necessary. Local tolerance of Tenoxicam given parenterally was good. The following undesirable effects have been reported:
Frequency is greater than 1%-
+
+- Gastrointestinal tract: gastric, epigastric and abdominal discomfort, dyspepsia, heartburn, nausea.
+- Central nervous system: dizziness, headache.
+
+Frequency less than 1%-
+
+- Gastrointestinal tract: constipation, diarrhea, stomatitis, gastritis, vomiting, ulcers, Gl-bleeding including hematemesis and melena.
+- Central nervous system: fatigue, sleep disturbances, appetite loss, dry mouth, vertigo.
+- Skin: itching (also in the anal region after rectal administration), erythema, exanthema, rash, urticaria.
+- Urinary tract and kidneys: increase in BUN or creatinine, edema.
+- Liver and biliary tract: increased liver enzyme activity.
+- Cardiovascular system: palpitations.
+
+Isolated cases (frequency less than 0.01%)-
+
+- Gastrointestinal tract: Gl-perforation.
+- Central nervous system: visual disturbances.
+- Skin: Stevens-Johnson and Lyell's syndrome, photosensitivity reaction, vasculitis.
+- Blood: anemia, agranulocytosis, leukopenia, thrombocytopenia.
+- Hypersensitivity reactions: dyspnea, asthma, anaphylaxis, angioedema.
+- Cardiovascular system: elevated blood pressure, mainly in patients treated with cardiovascular drugs.
+- Liver/Biliary tract: hepatitis.
+
","NSAIDs have an inhibitory effect on prostaglandin synthesis and, when given during late pregnancy, may cause the closure of the fetal ductus arteriosus, prolong labor and delay parturition. Treatment during the third trimester of pregnancy should be avoided. Based on findings from single-dose administration, a very small amount (approximately 0.2%) of tenoxicam passes into breast milk. There is no evidence of adverse reactions in breast-fed infants of mothers taking Tenoxicam. Nevertheless, infants should be weaned or the drug discontinued.
","NSAIDs inhibit renal prostaglandin synthesis and consequently may have an undesirable effect on renal hemodynamics and on salt and water balance. It is necessary to adequately monitor the patient with a special emphasis on cardiac and renal function (BUN, creatinine, development of edema, weight gain, etc.) when giving Tenoxicam to patients with conditions that could increase their risk of developing renal failure, such as pre-existing renal disease, impaired renal function in diabetics, hepatic cirrhosis, congestive heart failure, volume depletion or concomitant treatment with potentially nephrotoxic drugs, diuretics and corticosteroids. Tenoxicam inhibits platelet aggregation and may affect hemostasis. Tenoxicam has no significant influence on blood coagulation factors, coagulation time, prothrombin time or activated thromboplastin time. Patients having coagulation disorders or receiving drug therapy that interferes with hemostasis should, however, be carefully observed when Tenoxicam is administered. Any patient being treated with Tenoxicam who presents with symptoms of gastrointestinal disease should be closely monitored. If peptic ulceration or gastrointestinal bleeding occurs, Tenoxicam should be immediately withdrawn. If severe skin reactions (e.g. Lyell's or Stevens-Johnson syndrome) occur, the treatment should be discontinued immediately. Adverse eye findings have been reported with Tenoxicam. Thus ophthalmic evaluation is recommended for patients who develop visual disturbances. Because of the high plasma protein binding of tenoxicam, caution is required when plasma albumin levels are markedly reduced. In common with anti-inflammatory drugs, Tenoxicam may mask the usual signs of infection. Tenoxicam Tablets should not be given to patients who either dislike or do not tolerate milk products.
","Use in Children & adolescent: Tenoxicam is not recommended for use in patients under 16 years of age, as the dose and indications in this population have not been established.
Effects on ability to drive and use machines: Patients experiencing adverse events that might affect driving or using machines, such as vertigo, dizziness or visual disturbances should refrain from driving a car or using machines.
","Although there is no experience of acute overdosage with Tenoxicam, it may be expected that the signs and symptoms mentioned under Undesirable effects would be more pronounced. Overdose should be countered by conventional measures to reduce absorption (e.g. gastrolavage and charcoal) and speed up elimination (e.g. cholestyramine).
",,,"Do not store above 30°C, protect from light & moisture. Keep out of the reach of children.
",13
+1040,Tenofovir Disoproxil Fumarate,tenofovir-disoproxil-fumarate-1040,https://medex.com.bd/attachments/MGmFDKlz9usurqinQWaJrwOj083C6o/tenofovir-disoproxil-fumarate-prescribing-information,Drugs for HIV / Anti-retroviral drugs,HIV infection,"This is indicated for the treatment of:
+
+- Chronic hepatitis B virus infection in adults
+- HIV infected adults in combination with other anti retroviral agents
+
","Drugs for HIV / Anti-retroviral drugs, Hepatic viral infections (Hepatitis B)
","Tenofovir Disoproxil Fumarate, an acyclic nucleotide analogue of adenosine monophosphate, is a pro-drug of Tenofovir. It shows activity against hepatitis B virus polymerase and HIV reverse transcriptase after phosphorylation to the active diphosphate form. Tenofovir diphosphate inhibits viral polymerase (reverse transcriptase) by directly competing with the natural substrate deoxyribonucleotide and by causing DNA chain termination after its incorporation into viral DNA.
","The recommended dose of Tenofovir in chronic hepatitis B virus infection in adults 18 years of age and older with adequate renal function is 300 mg once daily with or without food.
",,"Co-administration of Tenofovir with anti-retroviral, entecavir, lamivudine, methadone, oral contraceptives, ribavirin and tacrolimus did not result in significant drug interactions. The effects of co-administration of Tenofovir with other drugs that are renally eliminated or are known to affect renal function have not been evaluated.
","Tenofovir is contraindicated in patients with known hypersensitivity to Tenofovir or any component of the product.
","The most common side effects are nausea, vomiting, diarrhea and flatulence.
","Pregnancy: Pregnancy category B. It should be used during pregnancy only if clearly needed.
Lactation: It is not known whether it is excreted in human milk. Mothers should be instructed not to breast feed if they are taking Tenofovir.
","Co-administration with other drugs: Tenofovir should not be administered concurrently with Emtricitabine & Tenofovir combination or Adefovir Dipivoxil.
Lactic Acidosis & Severe Hepatomegaly with Steatosis: Though the risk of occurrence of lactic acidosis is low for Tenofovir, treatment should be suspended in any patient who develops lactic acidosis or hepatotoxicity.
Exacerbation of hepatitis after discontinuation of treatment: Discontinuation of Tenofovir
therapy may be associated with severe acute exacerbation of hepatitis.
","Pediatric use: Safety and effectiveness of Tenofovir in pediatric patients below the age of 18 years have not been established.
Geriatrics use: Clinical studies of Tenofovir did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. But care should be taken in dose selection, and it may be useful to monitor renal function.
Renal Impairment: Haemodialysis patients: 300 mg once every 7 days or after a cumulative total of 12 hr of dialysis.
+
+- CrCl (10-29 mL/min): 300 mg 72-96 hrly.
+- CrCl (30-49 mL/min): 300 mg 48 hrly.
+
+
Hepatic impairment: No dose adjustment is required in patients with hepatic impairment.
","There is no experience of Tenofovir overdose reported in patients
",,,"Store in a cool and dry place, protected from light and moisture. Keep the medicine out of the reach of children.
",12
+1357,Tenofovir Alafenamide,tenofovir-alafenamide-1357,https://medex.com.bd/attachments/jrZCIRbhZ44GV6PbJLAfLAsh3jz5TC/tenofovir-alafenamide-prescribing-information,Hepatic viral infections (Hepatitis B),Liver disease,"Tenofovir Alafenamide is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor and is indicated for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease.
","Hepatic viral infections (Hepatitis B)
","Tenofovir alafenamide is a phosphonamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analog). Tenofovir alafenamide as a lipophilic cell-permeant compound enters primary hepatocytes by passive diffusion and by the hepatic uptake transporters OATP1B1 and OATP1B3. Tenofovir alafenamide is then converted to tenofovir through hydrolysis primarily by carboxylesterase 1 (CES1) in primary hepatocytes. Intracellular tenofovir is subsequently phosphorylated by cellular kinases to the pharmacologically active metabolite tenofovir diphosphate. Tenofovir diphosphate inhibits HBV replication through incorporation into viral DNA by the HBV reverse transcriptase, which results in DNA chain-termination.
Tenofovir diphosphate is a weak inhibitor of mammalian DNA polymerases that include mitochondrial DNA polymerase γ and there is no evidence of toxicity to mitochondria in cell culture.
","Testing Prior To Initiation Of Tenofovir Alafenamide: Prior to initiation of Tenofovir Alafenamide, patients should be tested for HIV-1 infection. Tenofovir Alafenamide alone should not be used in patients with HIV infection
It is recommended that serum creatinine, serum phosphorous, estimated creatinine clearance, urine glucose, and urine protein be assessed before initiating Tenofovir Alafenamide and during therapy in all patients as clinically appropriate
Recommended Dosage In Adults: The recommended dosage of Tenofovir Alafenamide is 25 mg (one tablet) taken orally once daily with food
",,"Tenofovir is a substrate of P-glycoprotein (P-gp) and BCRP. Drugs that strongly affect P-gp and BCRP activity may lead to changes in Tenofovir absorption. Consult the full prescribing information prior to and during treatment for potential drug drug interactions.
","None
","The following adverse reactions are discussed in other sections of the labeling:
+
+- Lactic Acidosis/Severe Hepatomegaly with Steatosis
+- Severe Acute Exacerbation of Hepatitis B
+- New Onset or Worsening of Renal Impairment
+
+The most common side effects are headache, stomach pain, tiredness, cough, nausea, back pain
","Before you take Tenofovir Alafenamide, tell your healthcare provider about all of your medical conditions, including if you are pregnant or plan to become pregnant. It is not known if Tenofovir Alafenamide will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with Tenofovir Alafenamide.
Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.
",,"Pediatric Use: Safety and effectiveness of Tenofovir Alafenamide in pediatric patients less than 18 years of age have not been established.
Geriatric Use: Clinical trials of Tenofovir Alafenamide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Renal Impairment: No dosage adjustment of Tenofovir Alafenamide is required in patients with mild, moderate, or severe renal impairment. Tenofovir Alafenamide is not recommended in patients with end stage renal disease (estimated creatinine clearance below 15 mL per minute)
Hepatic Impairment: No dosage adjustment of Tenofovir Alafenamide is required in patients with mild hepatic impairment (Child-Pugh A). The safety and efficacy of Tenofovir Alafenamide in patients with decompensated cirrhosis (Child-Pugh B or C) have not been established; therefore Tenofovir Alafenamide is not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment
","If overdose occurs, monitor patient for evidence of toxicity. Treatment of overdosage with Tenofovir Alafenamide consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. Tenofovir is efficiently removed by hemodialysiswith an extraction coefficient of approximately 54%
",,,"Store below 86°F (30°C). Keep in its original container. Keep the container tightly closed.
",11
+1792,Tenecteplase,tenecteplase-1792,https://medex.com.bd/attachments/w7Mt2zsoBNaAtJEvowdR3fhrqK1YkB/tenecteplase-prescribing-information,Fibrinolytics (Thrombolytics),Myocardial infarction,"Tenecteplase is indicated for use in the reduction of mortality associated with acute myocardial infarction (AMI). Treatment should be initiated as soon as possible after the onset of acute myocardial infarction symptoms.
","Fibrinolytics (Thrombolytics)
","Tenecteplase is a modified form of human tissue plasminogen activator (tPA) that binds to fibrin and converts plasminogen to plasmin. In the presence of fibrin, in vitro studies demonstrate that Tenecteplase conversion of plasminogen to plasmin is increased relative to its conversion in the absence of fibrin. This fibrin specificity decreases systemic activation of plasminogen and the resulting degradation of circulating fibrinogen as compared to a molecule lacking this property. Following administration of 30, 40, or 50 mg of Tenecteplase, there are decreases in circulating fibrinogen (4%-15%) and plasminogen (11%-24%). The clinical significance of fibrinspecificity on safety (e.g., bleeding) or efficacy has not been established. Biological potency is determined by an in vitro clot lysis assay and is expressed in Tenecteplase-specific units. The specific activity of Tenecteplase has been defined as 200 units/mg.
","Tenecteplase is for intravenous administration only. The recommended total dose should not exceed 50 mg and is based upon patient weight. A single bolus dose should be administered over 5 seconds based on patient weight. Treatment should be initiated as soon as possible after the onset of AMI symptoms.
+
+- Patient Weight <60 kg: 30 mg Tenecteplase
+- Patient Weight ≥60 to <70 kg: 35 mg Tenecteplase
+- Patient Weight ≥70 to <80 kg: 40 mg Tenecteplase
+- Patient Weight ≥80 to <90 kg: 45 mg Tenecteplase
+- Patient Weight ≥90 kg: 50 mg Tenecteplase
+
","
+- The product should be visually inspected prior to administration for particulate matter and discoloration. Tenecteplase may be administered as reconstituted at 5 mg/mL.
+- Precipitation may occur when Tenecteplase is administered in an IV line containing dextrose. Dextrose-containing lines should be flushed with a saline-containing solution prior to and following single bolus administration of Tenecteplase.
+- Reconstituted Tenecteplase should be administered as a single IV bolus over 5 seconds.
+- Because Tenecteplase contains no antibacterial preservatives, it should be reconstituted immediately before use. If the reconstituted Tenecteplase is not used immediately, refrigerate the Tenecteplase vial at 2-8°C and use within 8 hours.
+- Although the supplied syringe is compatible with a conventional needle, this syringe is designed to be used with needleless IV systems. From the information below, follow the instructions applicable to the IV system in use.
+
","Formal interaction studies of Tenectaplase with other drugs have not been performed. Patients studied in clinical trials of Tenecteplase were routinely treated with heparin and aspirin. Anticoagulants (such as heparin and vitamin K antagonists) and drugs that alter platelet function. (such as acetylsalicylic acid, dipyridamole, and GP IIb/IIIa inhibitors) may increase the risk of bleeding if administered prior to, during, or after Tenectaplase therapy.
","Tenecteplase therapy in patients with acute myocardial infarction is contraindicated in the following situations because of an increased risk of bleeding:
+
+- Active internal bleeding
+- History of cerebrovascular accident
+- Intracranial or intraspinal surgery or trauma within 2 months
+- Intracranial neoplasm, arteriovenous malformation, or aneurysm
+- Known bleeding diathesis
+- Severe uncontrolled hypertension
+
","The most frequent adverse reaction associated with Tenecteplase is bleeding. Should serious bleeding occur, concomitant heparin and antiplatelet therapy should be discontinued. Death or permanent disability can occur in patients who experience stroke or serious bleeding episodes. For Tenecteplase-treated patients in ASSENT-2, the incidence of intracranial hemorrhage was 0.9% and any stroke was 1.8%. The incidence of all strokes, including intracranial bleeding, increases with increasing age
","Pregnancy: Tenectaplase has been shown to elicit maternal and embryo toxicity in rabbits given multiple IV administrations. In rabbits administered 0.5, 1.5, and 5.0 mg/kg/day during organogenesis, vaginal hemorrhage resulted in maternal deaths. Subsequent embryonic deaths were secondary to maternal hemorrhage and no fetal anomalies were observed. Tenectaplase does not elicit maternal and embryo toxicity in rabbits following a single IV administration. Thus, in developmental toxicity studies conducted in rabbits, the no observable effect level (NOEL) of a single IV administration of Tenectaplase on maternal or developmental toxicity (5 mg/kg) was approximately 7 times human exposure (based on AUC) at the dose for AMI. There are no adequate and well controlled studies in pregnant women. Tenectaplase should be given to pregnant women only if the potential benefits justify the potential risk to the fetus.
Nursing Mothers: It is not known if Tenectaplase is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tenectaplase is administered to a nursing woman.
","General: Standard management of myocardial infarction should be implemented concomitantly with Tenecteplase treatment. Arterial and venous punctures should be minimized. Noncompressible arterial puncture must be avoided and internal jugular and subclavian venous punctures should be avoided to minimize bleeding from the noncompressible sites. In the event of serious bleeding, heparin and antiplatelet agents should be discontinued immediately. Heparin effects can be reversed by protamine.
Readministration: Readministration of plasminogen activators, including Tenecteplase, to patients who have received prior plasminogen activator therapy has not been systematically studied. Three of 487 patients tested for antibody formation to Tenecteplase had a positive antibody titer at 30 days. The data reflect the percentage of patients whose test results were considered positive for antibodies to Tenecteplase in a radioimmunoprecipitation assay, and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Tenecteplase with the incidence of antibodies to other products may be misleading. Although sustained antibody formation in patients receiving one dose of Tenecteplase has not been documented, readministration should be undertaken with caution.
Hypersensitivity: Hypersensitivity, including urticarial / anaphylactic reactions, have been reported after administration of Tenecteplase (e.g., anaphylaxis, angioedema, laryngeal edema, rash, and urticaria). Monitor patients treated with Tenecteplase during and for several hours after infusion. If symptoms of hypersensitivity occur, appropriate therapy should be initiated.
","Pediatric Use: The safety and effectiveness of Tenecteplase in pediatric patients have not been established.
In elderly patients: The benefits of Tenecteplase on mortality should be carefully weighed against the risk of increased adverse events, including bleeding.
",,,,"Store lyophilized Tenecteplase at controlled room temperature not to exceed 30°C or under refrigeration 2-8°C. Do not use beyond the expiration date stamped on the vial.
",12
+1039,Temozolomide,temozolomide-1039,https://medex.com.bd/attachments/8zBrBp9YEIZfo4wrJtJQVJBAbUFdTf/temozolomide-prescribing-information,Cytotoxic Chemotherapy,Metastatic melanoma,"Newly Diagnosed Glioblastoma Multiforme: Temozolomide is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.
Refractory Anaplastic Astrocytoma: ... Read more
Newly Diagnosed Glioblastoma Multiforme: Temozolomide is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.
Refractory Anaplastic Astrocytoma: Temozolomide is indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.
","Cytotoxic Chemotherapy
","Temozolomide, a triazene, is an inactive prodrug. It is chemically hydrolysed to 3-methyl-(triazen-1-yl) imidazole-4-carboxamide (MTIC), the active metabolite of dacarbazine. The cytotoxicity of MTIC is believed to be due alkylation of DNA, mainly at the O6 and N7 positions of guanine.
","Newly diagnosed glioblastoma multiforme: 75 mg/m<sup>2</sup> for 42 days concomitant with focal radiotherapy followed by initial maintenance dose of 150 mg/m<sup>2</sup> once daily for Days 1-5 of a 28-day cycle of Temozolomide for 6 cycles
Refractory Anaplastic Astrocytoma: Initial dose 150 mg/m<sup>2</sup> once daily for 5 consecutive days per 28-day treatment cycle.
The recommended dose for Temozolomide as an intravenous infusion over 90 minutes is the same as the dose for the oral capsule formulation. Bioequivalence has been established only when Temozolomide for Injection was given over 90 minutes
","Should be taken on an empty stomach. Take at least 1 hr before meals.
","Reduced effectiveness of vaccines and generalised infection may occur in patients immunised with live vaccines. Decreased temozolomide clearance with valproic acid.
","Hypersensitivity to dacarbazine. Severe myelosupression. Pregnancy.
","Nausea, vomiting, taste perversion, constipation, diarrhoea, abdominal pain, stomatitis, anorexia, headache, fatigue, convulsions, dizziness, memory impairment, impaired concentration, tremors, blurred vision, hearing impairment, speech disorder, rash, infection, oral candidiasis, dyspnoea, coughing, neutropenia, thrombocytopenia, leucopenia, anaemia, hyperglycemia, decreased wt, insomnia, anxiety, alopecia, muscle weakness, urinary incontinence, increased alanine aminotransferase. Rarely, myelodysplastic syndrome and secondary malignancies.
","Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants and tumorigenicity shown for temozolomide in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of Temozolomide to the mother.
","Severe hepatic and renal impairment. Elderly >70 yr, children. Women of child bearing potential should avoid becoming pregnant during therapy. Males should be advised not to father a child up to 6 mth after treatment and to consider cryoconservation of sperms due to possibility of irreversible infertility. Unknown if distributed into breastmilk, discontinue nursing due to potential risk. May impair ability to drive or operate machinery. Swallow capsules whole with a full glass of water on an empty stomach or at bedtime. Do not take a 2nd dose if capsules are vomited. Monitor CBC wkly during concomitant therapy and on day 22 of each 28 day treatment cycle, followed by wkly blood count until recovery. Hepatitis screening and prophylactic therapy with antiviral agents as clinically indicated to be considered. Prophylaxis for Pneumocystis jiroveci (or Pneumocystis carinii) pneumonia (PCP) needed for all patients receiving concomitant temozolomide and radiation therapy for the 42-day regimen; if patients experience lymphocytopenia during the concomitant phase of therapy, PCP prophylaxis should be continued until recovery from lymphocytopenia. Monitor closely for PCP development in all patients. Anti-emetic prophylaxis recommended.
","Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: Clinical studies of temozolomide did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Renal Impairment: Caution should be exercised when temozolomide is administered to patients with severe renal impairment
Hepatic Impairment: Caution should be exercised when temozolomide is administered to patients with severe hepatic impairment
","Doses of 500, 750, 1000, and 1250 mg/m2 (total dose per cycle over 5 days) have been evaluated clinically in patients. Dose-limiting toxicity was hematologic and was reported with any dose but is expected to be more severe at higher doses. An overdose of 2000 mg per day for 5 days was taken by one patient and the adverse reactions reported were pancytopenia, pyrexia, multi-organ failure, and death. There are reports of patients who have taken more than 5 days of treatment (up to 64 days), with adverse reactions reported including bone marrow suppression, which in some cases was severe and prolonged, and infections and resulted in death. In the event of an overdose, hematologic evaluation is needed. Supportive measures should be provided as necessary.
",,,"Store at 15-30° C.
",13
+1280,Temazepam,temazepam-1280,https://medex.com.bd/attachments/6mUnPBVTNoC4uXBzNH90UXTodlQEck/temazepam-prescribing-information,Benzodiazepine antagonist,Insomnia and sleep disturbances,"Temazepam is indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy ... Read more
Temazepam is indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.
","Benzodiazepine antagonist, Benzodiazepine hypnotics, Benzodiazepine sedatives
","Gamma-Aminobutyric acid (GABA) is considered the principal inhibitory neurotransmitter in the human body. When GABA binds to GABA(a) receptors found in neuron synapses, chloride ions are conducted across neuron cell membranes via an ion channel in the receptors. With enough chloride ions conducted, the local, associated neuron membrane potentials are hyperpolarized - making it more difficult or less likely for action potentials to fire, ultimately resulting in less excitation of the neurons.
Subsequently, benzodiazepines like temazepam can bind to benzodiazepine receptors that are components of various varieties of GABA(a) receptors. This binding acts to enhance the effects of GABA by increasing GABA affinity for the GABA(a) receptor, which ultimately enhances GABA ligand binding at the receptors. This enhanced ligand binding of the inhibitory neurotransmitter GABA to the receptors increases the aforementioned chloride ion conduction (perhaps reportedly via an increase in the frequency of the chloride channel opening), resulting in a hyperpolarized cell membrane that prevents further excitation of the associated neuron cells. Combined with the notion that such benzodiazepine receptor associated GABA(a) receptors exist both peripherally and in the CNS, this activity consequently facilitates various effects like sedation, hypnosis, skeletal muscle relaxation, anticonvulsant activity, and anxiolytic action
","While the recommended usual adult dose is 15 mg before retiring, 7.5 mg may be sufficient for some patients, and others may need 30 mg. In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency. In elderly or debilitated patients, it is recommended that therapy be initiated with 7.5 mg until individual responses are determined.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
",,,"Benzodiazepines may cause fetal harm when administered to a pregnant woman. An increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. Transplacental distribution has resulted in neonatal CNS depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy.
Reproduction studies in animals with temazepam were performed in rats and rabbits. In a perinatal-postnatal study in rats, oral doses of 60 mg/kg/day resulted in increasing nursling mortality. Teratology studies in rats demonstrated increased fetal resorptions at doses of 30 and 120 mg/kg in one study and increased occurrence of rudimentary ribs, which are considered skeletal variants, in a second study at doses of 240 mg/kg or higher. In rabbits, occasional abnormalities such as exencephaly and fusion or asymmetry of ribs were reported without dose relationship. Although these abnormalities were not found in the concurrent control group, they have been reported to occur randomly in historical controls. At doses of 40 mg/kg or higher, there was an increased incidence of the 13th rib variant when compared to the incidence in concurrent and historical controls.
Temazepam is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Patients should be instructed to discontinue the drug prior to becoming pregnant. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered.
","The most common side effects of temazepam are:
+
+- drowsiness
+- headache
+- tiredness
+- nervousness
+- dizziness
+- nausea
+
","Pregnancy Category X. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when temazepam is administered to a nursing woman.
","Since the risk of the development of oversedation, dizziness, confusion, and/or ataxia increases substantially with larger doses of benzodiazepines in elderly and debilitated patients, 7.5 mg of temazepam is recommended as the initial dosage for such patients. Temazepam should be administered with caution in severely depressed patients or those in whom there is any evidence of latent depression; it should be recognized that suicidal tendencies may be present and protective measures may be necessary. The usual precautions should be observed in patients with impaired renal or hepatic function and in patients with chronic pulmonary insufficiency. If temazepam is to be combined with other drugs having known hypnotic properties or CNS-depressant effects, consideration should be given to potential additive effects. The possibility of a synergistic effect exists with the co-administration of temazepam and diphenhydramine. One case of stillbirth at term has been reported 8 hours after a pregnant patient received temazepam and diphenhydramine. A cause and effect relationship has not yet been determined.
",,,,,"Store temazepam at room temperature, 20° to 25°C. Keep temazepam and all medicines out of reach of children.
",9
+572,Telmisartan + Hydrochlorothiazide,telmisartan-hydrochlorothiazide-572,https://medex.com.bd/attachments/hXiDvnm0EPYt3GDbe0Un6GCTV1mtRx/telmisartan-hydrochlorothiazide-prescribing-information,Combined antihypertensive preparations,Myocardial infarction,"Telmisartan and Hydrochlorothiazide is indicated for the treatment of hypertension, to lower blood pressure. This combination can be used alone or with other antihypertensive agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
","Combined antihypertensive preparations
","Telmisartan: Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Telmisartan blocks the vasoconstrictor and aldosteronesecreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis.
There is also an AT2 receptor found in many tissues, but AT2 is not known to be associated with cardiovascular homeostasis. Telmisartan has much greater affinity (>3,000-fold) for the AT1 receptor than for the AT2 receptor.
Telmisartan does not inhibit ACE (kininase II) nor does it bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of telmisartan on blood pressure.
Hydrochlorothiazide: Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium salt and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so coadministration of an ARB tends to reverse the potassium loss associated with these diuretics. The mechanism of the antihypertensive effect of thiazides is not fully understood.
","Initiate a patient whose blood pressure is not adequately controlled with-
+
+- Telmisartan monotherapy 80 mg: Telmisartan and Hydrochlorothiazide 80 mg/12.5 mg once daily. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary.
+- Hydrochlorothiazide 25 mg once daily, or is controlled but who experiences hypokalemia with this regimen: Telmisartan and Hydrochlorothiazide 80 mg/12.5 mg once daily. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary.
+
+Telmisartan and Hydrochlorothiazide may be administered with other antihypertensive drugs.
",,"Caution should be exercised before taking this drug if you are taking aliskiren, digoxin, lithium, other medicines for high blood pressure, NSAIDs (such as aspirin, ibuprofen, naproxen, others), corticosteroids (such as prednisone, hydrocortisone, others), angiotensin-converting enzyme (ACE) blockers (such as benazepril, enalapril, lisinopril) angiotensin II receptor blockers (such as losartan, olmesartan, valsartan). This product may interfere with certain laboratory tests (including parathyroid test, protein-bound iodide test), possibly causing false test results.
","This is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to Telmisartan, Hydrochlorothiazide or any other component of this product. Do not co-administer Aliskiren with this tablet in patients with Diabetes.
","Common side effects include dizziness, drowsiness, tired feeling, flushing (warmth, redness, or tingly feeling), back pain, nausea, diarrhea, stomach pain. Other adverse events include allergy, fever, leg pain, chest pain, insomnia, somnolence, and dry mouth, elevations of liver enzymes or serum bilirubin, leg cramps, myalgia, dermatitis. Other adverse events that have been reported includes weakness, gastric irritation, photosensitivity, urticaria, muscle spasm, restlessness.
","Pregnancy Category D. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Telmisartan and hydrochlorothiazide as soon as possible.
Nursing Mothers: It is not known whether telmisartan is excreted in human milk, but telmisartan was shown to be present in the milk of lactating rats. Thiazides appear in human milk. Because of the potential for adverse effects on the nursing infant, decide whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
","Before using this medication, tell your doctor about your medical history, especially of kidney disease, liver disease, bile duct blockage, loss of too much body water and/or minerals (dehydration), untreated mineral imbalance (such as low or high potassium), gout, lupus. If you have diabetes, this medication may affect your blood sugar. Check your blood sugar regularly as directed by your doctor. This product may affect your body potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor. This drug may make you dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Report prolonged diarrhea or vomiting to your doctor. Be sure to drink enough fluids to prevent dehydration unless your doctor directs you otherwise.
","Pediatric Use: Safety and effectiveness of Telmisartan and Hydrochlorothiazide in pediatric patients have not been established.
Geriatric Use: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant diseases or other drug therapy.
Use in Patients with Hepatic Impairment: Patients with biliary obstructive disorders or hepatic insufficiency should initiate treatment under close medical supervision.
Use in Patients with Renal Impairment: Safety and effectiveness of Telmisartan and Hydrochlorothiazide in patients with severe renal impairment (Cr.Cl. <30 ml/min) have not been established. In patients with severe renal impairment, Telmisartan and Hydrochlorothiazide tablets are not recommended. No dose adjustment is required in patients with mild (Cr.Cl. 60 to 90 ml/min) or moderate (Cr.Cl. 30 to 60 ml/min) renal impairment.
","The most likely manifestations of overdosage are hypertension, dizziness, tachycardia, bradycardia, hypokalemia, hypochloremia, hyponatremia and dehydration etc. Telmisartan is not removed by hemodialysis and the degree to which hydrochlorothiazide is removed by hemodialysis has not been established.
",,,"Keep out of the reach of children. Keep in a cool and dry place. Protect from light.
",12
+1038,Telmisartan,telmisartan-1038,https://medex.com.bd/attachments/7CneIzz8u0LmrWVm5hSlS3w1hhhbwf/telmisartan-prescribing-information,Angiotensin-ll receptor blocker,Hypertension,"Telmisartan is indicated in-
Hypertension: Treatment of essential hypertension in adults.
Cardiovascular prevention: Reduction of cardiovascular morbidity in adults with:
+
+- Atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or
+- Type 2 diabetes mellitus with documented target organ damage.
+
","Angiotensin-ll receptor blocker
","Telmisartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis. Telmisartan has much greater affinity (>3,000 fold) for the AT1 receptor than for the AT2 receptor. Because telmisartan does not inhibit ACE (kininase II), it does not affect the response to bradykinin. Telmisartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
","Dosage must be individualized. The usual starting dose of Telmisartan tablets is 40 mg once a day. Blood pressure response is dose-related over the range of 20 to 80 mg. Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. When additional blood pressure reduction beyond that achieved with 80 mg Telmisartan is required, may switch to the combination. No initial dosage adjustment is necessary for elderly patients or patients with renal impairment, including those on hemodialysis. Patients on dialysis may develop orthostatic hypotension; their blood pressure should be closely monitored. Telmisartan tablets may be administered with other antihypertensive agents. Telmisartan tablets may be administered with or without food. Initial therapy with Telmisartan is not recommended in patients ≥75 years old or with hepatic impairment.
",,"
+- NSAIDS: Increased risk of renal impairment and loss of antihypertensive effect.
+- Co-administration with aliskiren with Telmisartan: in patients with diabetes should be avoided.
+
","Known hypersensitivity to this product or any of its components.
","In hypertensive patients: The most common side effects of Telmisartan tablets include sinus pain and congestion (sinusitis), back pain, diarrhea etc.
For patients of cardiovascular risk reduction: The most common side effects of Telmisartan tablets in CV risk reduction include intermittent claudication and skin ulcer.
","Pregnancy Category C (first trimester) and D (second and third trimester). Because of the potential for adverse effects on the nursing infant, decide whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
","
+- Avoid fetal or neonatal exposure.
+- Hypotension.
+- Monitor carefully in patients with impaired hepatic or renal function.
+- Avoid concomitant use of an ACE inhibitor and angiotensin receptor blocker.
+
","Pediatric use: The safety and effectiveness of Telmisartan in pediatric patients have not been established.
Geriatric use: No overall differences in effectiveness and safety were observed in these patients compared to younger patients.
Hepatic impairment: Monitor carefully and up titrate slowly in patients with biliary obstructive disorders or hepatic insufficiency.
","The most likely manifestation of overdosage with Telmisartan tablets would be hypotension, dizziness and tachycardia; bradycardia, increase in serum creatinine and acute renal failure could occur from parasympathetic (vagal) stimulation.
",,,"Do not store above 30°C. Protect from light and high humidity. Keep out of the reach of children.
",12
+1037,Telbivudine,telbivudine-1037,https://medex.com.bd/attachments/xakKDG2fztymU1ANrJ9mmibE8ubPor/telbivudine-prescribing-information,Hepatic viral infections (Hepatitis B),Hepatitis B virus,"Chronic Hepatitis B: Telbivudine is indicated for the treatment of chronic hepatitis B in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. The following points should ... Read more
Chronic Hepatitis B: Telbivudine is indicated for the treatment of chronic hepatitis B in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. The following points should be considered when initiating therapy with Telbivudine:
+
+- This indication is based on virologic, serologic, biochemical and histologic responses in nucleoside treatment naïve adult patients with HBeAg positive and HBeAg negative chronic hepatitis B with compensated liver disease
+- For HBeAg-positive patients, Telbivudine should only be initiated in patients with HBV DNA less than 9 log10 copies per mL and ALT greater than or equal to 2x Upper Limit of Normal (ULN) prior to treatment.
+- For HBeAg-negative patients, Telbivudine should only be initiated in patients with HBV DNA less than 7 log10 copies per mL prior to treatment.
+- On-treatment response should guide continued therapy
+- Telbivudine has not been evaluated in patients co-infected with HIV, HCV or HDV.
+- Telbivudine has not been evaluated in liver transplant recipients or in patients with decompensated liver disease.
+- Telbivudine has not been studied in well-controlled trials for the treatment of patients with established nucleoside analog reverse transcriptase inhibitor-resistant hepatitis B virus infection, but is expected to be cross-resistant to lamivudine.
+- The safety and efficacy of Telbivudine have not been evaluated in Black/African American or Hispanic patients
+
","Hepatic viral infections (Hepatitis B)
","Telbivudine is a synthetic thymidine nucleoside analogue with activity against hepatitis B virus (HBV). Telbivudine is the unmodified β–L enantiomer of the naturally occurring nucleoside, thymidine. It undergoes phosphorylation via interaction with cellular kinases to form the active metabolite, telbivudine 5'-triphosphate.
Telbivudine 5'–triphosphate inhibits HBV DNA polymerase (reverse transcriptase) by competing with the natural substrate, thymidine 5'–triphosphate. This leads to the chain termination of DNA synthesis, thereby inhibiting viral replication. Incorporation of telbivudine 5'–triphosphate into viral DNA also causes DNA chain termination, resulting in inhibition of HBV replication. Telbivudine inhibits anticompliment or second-strand DNA.
","Adults and Adolescents (16 years of age and older): Due to higher rates of resistance that may develop with longer term treatment among patients with incomplete viral suppression, treatment should only be initiated, if pre-treatment HBV DNA and ALT measurements are known, in the following patient populations-
For HBeAg-positive patients, HBV DNA should be less than 9 log10 copies per mL and ALT should be greater than or equal to 2x ULN prior to treatment with Telbivudine.
For HBeAg-negative patients, HBV DNA should be less than 7 log10 copies per mL prior to treatment with Telbivudine.
HBV DNA levels should be monitored at 24 weeks of treatment to assure complete viral suppression (HBV DNA less than 300 copies per mL). Alternate therapy should be initiated for patients who have detectable HBV DNA after 24 weeks of treatment. Optimal therapy should be guided by further resistance testing.
The recommended dose of Telbivudine for the treatment of chronic hepatitis B: 600 mg once daily, taken orally, with or without food. Telbivudine Oral Solution (30 mL) may be considered for patients who have difficulty with swallowing tablets.
",,"Altered plasma concentration with drugs that affect renal function (e.g. aminoglycosides, loop diuretics, platinum compounds, vancomycin, amphotericin B). May increase risk of myopathy with other drugs associated with myopathy (e.g. azole antifungals, ciclosporin, corticosteroids, erythromycin, fibrates, HMG-CoA reductase inhibitors, penicillamine, zidovudine).
","Hypersensitivity. Combination of Telbivudine with pegylated interferon alfa-2a is contraindicated because of increased risk of peripheral neuropathy
","Cough, dizziness, fatigue, GI effects (e.g. abdominal pain, diarrhoea, nausea, vomiting, dyspepsia), rash, arthralgia, myalgia, myopathy, malaise, back pain, nasopharyngitis, headache, flu or flu-like symptoms, insomnia; increased serum amylase, lipase, creatine phosphokinase, alanine aminotransferase levels; peripheral neuropathy, rhabdomyolysis.
","Pregnancy Category B. Telbivudine is not teratogenic and has shown no adverse effects in developing embryos and fetuses in preclinical studies. Studies in pregnant rats and rabbits showed that telbivudine crosses the placenta. Developmental toxicity studies revealed no evidence of harm to the fetus in rats and rabbits at doses up to 1000 mg per kg per day, providing exposure levels 6- and 37-times higher, respectively, than those observed with the 600 mg per day dose in humans.
There are no adequate and well-controlled trials of Tyzeka in pregnant women. Because animal reproductive toxicity studies are not always predictive of human response, Tyzeka should be used during pregnancy only if potential benefits outweigh the risks.
","Severe acute exacerbations of hepatitis B. Monitor hepatic function in discontinued therapy. Lactic acidosis, severe hepatomegaly with steatosis, myopathy, rhabdomyolysis, uncomplicated myalgia. Discontinue if myopathy is diagnosed. Increased risk of peripheral neuropathy when combined with pegylated interferon α-2a. Decompensated cirrhosis, renal impairment or on hemodialysis; liver transplant recipients or under immunosuppressant therapy. May impair the ability to drive or operate machinery. Pregnancy. Childn <16 yr. Elderly.
",,,,,"Store Telbivudine Tablets and Oral Solution in the original bottle at room temperature (15° to 30°C)
",10
+1077,Teicoplanin,teicoplanin-1077,,Glycopeptide,Septic arthritis,"Teicoplanin injection is indicated for the treatment of serious infections due to staphylococci or streptococci. Following infections are treated more satisfactorily-
+
+- Prevention of infection (usually after surgery)
+- Oesteomyelitis
+- Septic arthritis
+- Septicaemia
+- Inflammation of the lining of the heart cavity and heart valves due to endocarditis
... Read more
Teicoplanin injection is indicated for the treatment of serious infections due to staphylococci or streptococci. Following infections are treated more satisfactorily-
+
+- Prevention of infection (usually after surgery)
+- Oesteomyelitis
+- Septic arthritis
+- Septicaemia
+- Inflammation of the lining of the heart cavity and heart valves due to endocarditis
+- Treatment of serious staphylococcal bacterial infections
+- Non-cardiac bacteremia
+- Dialysis associated peritonitis
+- Severe infections-RTI, UTI, SSTI etc.
+
","Glycopeptide
","Teicoplanin is a glycopeptide antibiotic that has shown in vitro bactericidal activity against both anaerobic and aerobic gram-positive organisms. Teicoplanin inhibits the growth of susceptible organisms by interfering with cell-wall biosynthesis at a site different from that affected by beta-lactams. It is active against staphylococci (including those resistant to methicillin and other beta-lactam antibiotics), streptococci, enterococci, Listeria monocytogenes, micrococci, group JK corynebacteria and gram-positive anaerobes including Clostridium difficile and peptococci.
","Adult or elderly patients with normal renal function:
Intravenously: Intravenous injection may be administered by rapid injection over 3-5 minutes, or slowly over a 30 minutes infusion by diluting with 0.9% Sodium Chloride or Hartmanns Solution or 5% Dextrose etc.
Intramascularly: An intramuscular injection of Teicoplanin should not exceed 3 ml at a single site.
","3 ml water for injection should be added slowly down the side wall of the vial of Teicoplanin 200 mg or 400 mg. The vial should be rolled gently between the palms until the powder is completely dissolved. During the rolling, we have to be cautious about the solution that it does not become foamy. The solution must not be shaken. If foam formed then it should be allowed to stand for 15 minutes for the foam to be subsided. The entire contents from the vial should be withdrawn slowly into a syringe.
","Teicoplanin should be administered with caution in patients receiving concurrent nephrotoxic or ototoxic drugs such as Aminoglycosides, Amphotericin B, Cyclosporine and Frusemide.
","Teicoplanin is contraindicated in patients who have exhibited previous hypersensitivity to Teicoplanin.
","Teicoplanin is generally well tolerated. Serious side-effects are rare. Side-effects are gastrointestinal like nausea, vomiting, diarrhea, CNS associated with urticaria, rash, anaphylactic shock as well as hearing problems like vertigo, tinnitus and vestibular disorder may occur.
","There are no adequate and well-controlled studies in pregnant women about administration of Teicoplanin; this drug should be used during pregnancy only if clearly needed. Information about the excretion of Teicoplanin in milk is not known.
","Teicoplanin should be administered with caution in patients with renal insufficiency, patients who require concurrent use of drugs which have ototoxic and/or nephrotoxic properties.
","Patients with renal impairment: For patients with impaired renal function, reduction of dosage is not required until the fourth day of Teicoplanin treatment. From the fourth day of treatment-
In mild renal insufficiency: Teicoplanin dose should be halved either by administering the initial unit dose every two days, or by administering half of this dose once a day when creatinine clearance is 40-60 ml/min.
In severe renal insufficiency: Teicoplanin dose should be 1/3 of the normal either by administering the initial unit dose every third day or by administering 1/3 of this dose once a day when creatinine clearance is less than 40 ml/min and in haemodialysed patients. Teicoplanin is not removed by dialysis.
",,,"3 ml water for injection should be added slowly down the side wall of the vial of Teicoplanin 200 mg or 400 mg. The vial should be rolled gently between the palms until the powder is completely dissolved. During the rolling, we have to be cautious about the solution that it does not become foamy. The solution must not be shaken. If foam formed then it should be allowed to stand for 15 minutes for the foam to be subsided. The entire contents from the vial should be withdrawn slowly into a syringe.
",,12
+1035,Tegaserod,tegaserod-1035,https://medex.com.bd/attachments/mZgflCc8Eawd6QevbHIRMaV29PeKbw/tegaserod-prescribing-information,Drugs for Irritable Bowel Syndrome,Irritable bowel syndrome and constipation,"Tegaserod is indicated for the symptomatic treatment of irritable bowel syndrome with constipation (IBS-C) in patients whose main symptoms are constipation and abdominal pain or discomfort. The maximum duration of treatment is 12 weeks and treatment should be discontinued if there has been no response after 4 weeks.
","Drugs for Irritable Bowel Syndrome
","Tegaserod is a serotonin type-4 (5HT4) receptor partial agonist. Tegaserod binds with high affinity at human 5HT4 receptors, present on caudate membranes, whereas it has no appreciable affinity for human recombinant 5HT3 receptors or human recombinant dopamine D2 receptors. In vitro and animal study has revealed that Tegaserod can trigger the peristaltic reflex via 5HT4 receptor activation and thereby enhance basal motor activity and normalize impaired GI motility.
","General recommended dosage for adult: Tegaserod 6 mg twice daily taken orally with a glass of water 30 minutes before meal. The maximum duration of treatment is 12 weeks and treatment should be discontinued after 4 weeks if no response has occurred.
Use in elderly: Dose adjustment is not necessary when administering Tegaserod to patients over 65 years old.
Use in children: There is no clinical trial in document to safety and efficacy of tegaserod in children. Therefore, it is not recommended for use in children.
","Patient should be advised to take Tegaserod (6 mg twice daily) 30 minutes before meal.
Patient should also be made aware of the possible occurrence of diarrhea during therapy. In most cases, the diarrhea occurred early, is transient, is most often observed as a single episode during the 12 week treatment period, and resolved with continued therapy.
Patients should be instructed to consult their physician if they experience new or worsening abdominal pain not typical of their IBS symptoms.
","No clinically relevant drug-drug interactions have been observed with dextromethorphan, theophylline, digoxin, oral contraceptives, and warfarin.
","Tegaserod is not recommended in patients with severe renal or hepatic impairment. It is also contraindicated in patients with hypersensitivity to tegaserod or any excipient of this formulation.
","Abdominal pain, diarrhea, nausea, flatulence, headache, fatigue, back pain etc.
","Pregnancy: In view of limited experience in human, use of Tegaserod during pregnancy is not recommended.
Nursing mothers: Tegaserod should not be prescribed to nursing mothers.
","Diarrhea was reported in some of the patients receiving Tegaserod in the Phase III clinical studies. Caution is required in patients in whom increased diarrhea could have negative effects. Patients who are currently experiencing or frequently experience diarrhea should not initiate therapy with Tegaserod.
","Renal impairment: No dosage adjustment is required in patients with mild to moderate renal impairment. Tegaserod is not recommended in patients with severe renal impairment.
Hepatic impairment: No dosage adjustment is required in patients with mild to moderate hepatic impairment, however, caution is recommended when using Tegaserod in this patient population. It has not been studied in patients with severe hepatic impairment, and therefore, it is not recommended in this group.
","Signs and symptoms of overdosage may include diarrhoea, headache, abdominal pain and orthostatic hypotension. As in any case of over dose, general supportive measures should be utilized.
",,,"Store at a cool and dry place, protected from light and moisture.
",13
+1187,Tioconazole,tioconazole-1187,https://medex.com.bd/attachments/KTpZqnlgDlvTNbkOIlTNfuerIcwCqb/tioconazole-vaginal-ointment-prescribing-information,Topical Antifungal preparations,Skin fungal infections,"Tioconazole is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As Tioconazole has been shown to be effective only for candidal vulvovaginitis, the diagnosis should be confirmed by KOH smears and/or cultures. Other pathogens commonly associated ... Read more
Tioconazole is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As Tioconazole has been shown to be effective only for candidal vulvovaginitis, the diagnosis should be confirmed by KOH smears and/or cultures. Other pathogens commonly associated with vulvovaginitis should be ruled out by appropriate methods.
Studies have shown that women taking oral contraceptives have a cure rate similar to those not taking such agents when treated with Tioconazole.
","Drugs used in Vaginal and Vulval condition, Topical Antifungal preparations
","Tioconazole interacts with 14-α demethylase, a cytochrome P-450 enzyme that converts lanosterol to ergosterol, an essential component of the yeast membrane. In this way, tioconazole inhibits ergosterol synthesis, resulting in increased cellular permeability. Tioconazole may also inhibit endogenous respiration, interact with membrane phospholipids, inhibit the transformation of yeasts to mycelial forms and the uptake of purine, impair triglyceride and/or phospholipid biosynthesis, and inhibit the movement of calcium and potassium ions across the cell membrane by blocking the ion transport pathway known as the Gardos channel.
","Topical: Apply & massage gently into the affected & surrounding skin area once or twice a day. In intertriginous areas, apply sparingly & smoothed in well to avoid macerating effects. Duration: 1-6 weeks.
Vaginal candidiasis:
+
+- Adult: As 6.5% ointment: Admin intravaginally at bedtime as a single dose.
+- Child: ≥12 yr Admin at bedtime as a single dose.
+
",,,"Tioconazole is contraindicated in individuals who have been shown to be sensitive to imidazole antifungal agents or to other components of the ointment.
","Occasional local transient & mild irritation; if hypersensitivity reaction develop, treatment should be discontinued & appropriate therapy should be instituted.
","Pregnancy Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Not for ophthalmic use.
","Safety and effectiveness in pregnant and diabetic patients have not been established
",,,,,9
+1073,Tinidazole,tinidazole-1073,https://medex.com.bd/attachments/lzEQosaLEitJTZC2JdCpQqYykkDXl4/tinidazole-prescribing-information,Amoebicides,Vaginal trichomoniasis,"Trichomoniasis: Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis. The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners ... Read more
Trichomoniasis: Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis. The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners of infected patients should be treated simultaneously in order to prevent re-infection.
Giardiasis: Tinidazole is indicated for the treatment of giardiasis caused by Giardia duodenalis in both adults and pediatric patients older than three years of age. Sections or subsections omitted from the full prescribing information are not listed.
Amebiasis: Tinidazole is indicated for the treatment of intestinal amebiasis and amebic liver abscess caused by Entamoeba histolytica in both adults and pediatric patients older than three years of age. It is not indicated in the treatment of asymptomatic cystpassage.
Bacterial Vaginosis: Tinidazole is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, or anaerobic vaginosis) in non-pregnant women.
Other pathogens commonly associated with vulvovaginitis such as Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and Herpes simplex virus should be ruled out.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tinidazole and other antibacterialdrugs, Tinidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
","Amoebicides
","Tinidazole, a 5-nitroimidazole derivative with antimicrobial actions similar to metronidazole, is active against both protozoa (e.g. Trichomonas vaginalis, Entamoeba histolytica and Giardia lamblia) and obligate anaerobic bacteria. It damages DNA strands or inhibits DNA synthesis in microorganism.
","Prevention of Postoperative Infections :
+
+- Adult: A single oral dose of 2g approximately 12 hours before surgery.
+- Children less than 12 years: Data are not available to allow dosage recommendations for children below the age of 12 years in the prophylaxis of anaerobic infections.
+
+
Trichomoniasis: a single 2 g oral dose taken with food. Treat sexual partners with the same dose and at the same time
Giardiasis:
+
+- Adults: a single 2 g dose taken with food.
+- Pediatric patients older than three years of age: a single dose of 50 mg/kg (up to 2 g) with food
+
+Amebiasis, Intestinal:
+
+- Adults: 2 g per day for 3 days with food.
+- Pediatric patients older than three years of age: 50 mg/kg/day (up to 2 g per day) for 3 days with food
+
+Amebic liver abscess:
+
+- Adults: 2 g per day for 3-5 days with food.
+- Pediatric patients older than three years of age: 50 mg/kg/day (up to 2 g per day) for 3-5 days with food
+
+
Bacterial vaginosis: Non-pregnant, adult women: 2 g once daily for 2 days taken with food, or 1 g once daily for 5 days taken with food.
","Should be taken with food. Take during or immediately after meals.
","The following interactions were reported with metronidazole, which is chemically-related to tinidazole.
Alcohol, disulfiram: Avoid during tinidazole use and for 3 days afterward because cramps, nausea, vomiting, headaches, and flushing may occur.
Anticoagulants, oral (eg, warfarin): Anticoagulant effects may be increased. Anticoagulant dose may need to be adjusted during coadministration and for up to 8 days after discontinuation. Cholestyramine: Bioavailability of tinidazole may be decreased.
Cyclosporine, lithium, tacrolimus: Levels may be elevated by tinidazole, increasing the risk of toxicity.
Drugs that induce CYP3A4 (eg, fosphenytoin, phenobarbital, phenytoin, rifampin): May increase metabolism of tinidazole, decreasing plasma levels and therapeutic effect.
Drugs that inhibit CYP3A4 (eg, cimetidine, ketoconazole): May prolong t½ and decrease tinidazole Cl, increasing plasma levels and risk of adverse reactions.
Fluorouracil: Cl may be decreased by tinidazole, increasing the risk of adverse reactions
Fosphenytoin, phenytoin: The t½ may be prolonged and Cl reduced by tinidazole, increasing the risk of adverse reactions.
Oxytetracycline: Therapeutic effect of tinidazole may be decreased.
","As with other compounds of similar structure, tinidazole, is contraindicated in patients having, or with a history of, blood dyscrasias although no persistent haematological abnormalities have been noted in clinical or animal studies. Tinidazole should be avoided in patients with organic neurological disorders. Tinidazole should not be administered to patients with known hypersensitivity to the compound.
","Reported side effects have generally been infrequent, mild and self-limiting. Side effects from the gastrointestinal tract include nausea, vomiting, anorexia, diarrhoea and metallic taste. Hypersensitivity reactions, occasionally severe, may occur in rare cases in the form of skin rash, pruritis, urticaria and angioneurotic oedema. As with related compounds, tinidazole may produce transient leukopenia. Other rarely reported side-effects are headache, tiredness, furry tongue and dark urine.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Compounds of similar chemical structure have produced various neurological disturbances such as dizziness, vertigo, uncoordination, and ataxia. If, during therapy with tinidazole, abnormal neurological signs develop, therapy should be discontinued. Use in Pregnancy & Lactation: Tinidazole is contraindicated during the first trimester of pregnancy. While there is no evidence that tinidazole is harmful during the late stages of pregnancy, its use during the last two trimesters requires that the potential benefits outweigh the possible risk to mother and foetus. Tinidazole is excreted in breast milk in concentrations similar to those seen in serum. Tinidazole can be detected in breast milk for up to 72 hours following administration. Interruption of breast-feeding is recommended during tinidazole therapy and for 3 days following the last dose.
","Renal Impairment: Haemodialysis: Additional dose equal to half the usual dose at the end of haemodialysis.
",,,,"Store at room temperature & protected from light.
",12
+1071,Timolol Maleate,timolol-maleate-1071,https://medex.com.bd/attachments/uRSxsNKJ7AzeKwYrTuC3Wm5de43wUw/timolol-maleate-prescribing-information,Drugs for miotics and glaucoma,Open angle glaucoma,"Timolol Maleate Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
","Drugs for miotics and glaucoma
","Timolol is a non-selective β-adrenergic receptor blocker. It does not have significant intrinsic sympathomimetic activity, direct myocardial depressant activity or local anaesth activity. Exact mechanism of ocular hypotensive effect is unclear, but it is thought to be related to reduction of aqueous humour formation. β-blockade also causes lowering of BP.
","Eye drops Solution: Initially, instill 1 drop of 0.25% solution bid into the affected eye(s), may increase to 1 drop of 0.5% solution bid if there is inadequate response; decrease to 1 drop once daily if controlled. Do not exceed 1 drop bid of 0.5% solution.
Gel-forming eye drops: 0.25% or 0.5% Gel-forming eye drops: Instill 1 drop into the affected eye(s) once daily.
",,"Although Timolol used alone has little or no effect on pupil size, mydriasis resulting from concomitant therapy with Timolol Maleate and epinephrine has been reported occasionally. Drug interactions of Timolol Maleate have been noticed with concomitant administration of beta-adrenergic blocking agents (both oral and topical), calcium antagonists, catecholamine-depleting drugs, digitalis, quinidin, clonidine, injectable epinephrine.
","Timolol is contraindicated in patients with bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock, hypersensitivity to any component of this product.
","Burning and stinging sensation of the eyes, bradycardia, hypotension, arrhythmia and AV or SA nodal block, CHF, pulmonary oedema, Raynaud's phenomenon, headache, dizziness, fatigue, asthenia, abdominal discomfort, nausea, constipation, hypoglycaemia.
","Pregnancy: There are no adequate and well-controlled studies in pregnant women. Timolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: Timolol has been detected in breast milk following oral and ophthalmic drug administration. Because of the potential for serious adverse reactions from Timolol in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","Patients with inadequate cardiac function, DM, myasthenia gravis, cerebrovascular insufficiency, history of atopy. Avoid abrupt withdrawal as it may exacerbate angina symptoms or precipitate MI in patients with coronary artery disease, or precipitate thyroid crisis in patients with thyrotoxicosis. Patients undergoing major surgery. May mask signs of hyperthyroidism and hypoglycaemia. Ophth soln should not be used as monotherapy for angle-closure glaucoma. Renal and hepatic impairment. Pregnancy and lactation.
",,"There have been reports of inadvertent overdosage with Timolol Ophthalmic Solution resulting in systemic effects similar to those seen with systemic beta-adrenergic blocking agents such as dizziness, headache, shortness of breath, bradycardia, bronchospasm, and cardiac arrest.
",,,"Store between 15-30° C. Avoid freezing and protect from light.
",11
+1070,Tigecycline,tigecycline-1070,https://medex.com.bd/attachments/ybAuWmH1u2l6j8hUl74Ix78Ls4r1AA/tigecycline-prescribing-information,Tetracycline group of drugs,Skin and skin sructure infections,"Tigecycline is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
Complicated Skin and Skin structure Infections: Complicated skin and skin structure infections caused by Escherichia coli ... Read more
Tigecycline is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
Complicated Skin and Skin structure Infections: Complicated skin and skin structure infections caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, Enterobacter cloacae, Klebsiella pneumoniae and Bacteroides fragilis.
Complicated Intra-Abdominal Infections: Complicated intra-abdominal infections caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros.
Community-Acquired Bacterial Pneumonia: Community-acquired bacterial pneumonia caused by Streptococcus pneumoniae (penicillin-susceptible isolates), including cases with concurrent bacteremia, Haemophilus influenzae (beta-lactamase negative isolates), and Legionella pneumophila.
","Tetracycline group of drugs
","Tigecycline, a glycylcycline, inhibits protein translation in bacteria by binding to the 30S ribosomal subunit and blocking entry of amino-acyl tRNA molecules into the A site of the ribosome. This prevents incorporation of amino acid residues into elongating peptide chains. Tigecycline carries a glycylamido moiety attached to the 9-position of minocycline. The substitution pattern is not present in any naturally occurring or semisynthetic tetracycline and imparts certain microbiologic properties to tigecycline. Tigecycline is not affected by the two major tetracycline resistance mechanisms, ribosomal protection and efflux. Accordingly, tigecycline has demonstrated in vitro and in vivo activity against a broad spectrum of bacterial pathogens. There has been no cross resistance observed between tigecycline and other antibiotics. Tigecycline is not affected by resistance mechanisms such as beta-lactamases (including extended spectrum beta-lactamases), target site modifications, macrolide efflux pumps or enzyme target changes (e.g. gyrase/topoisomerase). In vitro studies have not demonstrated antagonism between tigecycline and other commonly used antibacterial drugs. In general, tigecycline is considered bacteriostatic.
","The duration of therapy should be guided by the severity and site of the infection and the patient's clinical and bacteriological progress. The recommended duration of treatment with Tigecycline for complicated skin and skin structure infections or for complicated intra-abdominal infections is 5 to 14 days and for community-acquired bacterial pneumonia is 7 to 14 days. The recommended daily dose is as follows:
Adults: The recommended dosage regimen for Tigecycline is an initial dose of 100 mg, followed by 50 mg every 12 hours. Intravenous (IV) infusions of Tigecycline should be administered over approximately 30 to 60 minutes every 12 hours.
Pediatric use: Safety and effectiveness in pediatric patients below the age of 18 years have not been established.
Geriatric use: No unexpected overall differences in safety or effectiveness were observed between these subjects and younger subjects.
",,"Drug interaction of Tigecycline with Digoxin and Warfarin is observed.
","Tigecycline is contraindicated for use in patients who have known hypersensitivity to Tigecycline.
","The most common treatment-emergent adverse events are nausea and vomiting which generally occurre during the first 1-2 days of therapy.
The following drug-related adverse events are reported infrequently in patients receiving Tigecycline: Injection site inflammation & pain, septic shock, allergic reaction, chills, thrombophlebitis, bradycardia, tachycardia, vasodilatation, anorexia, dry mouth, hypoglycemia, hyponatremia, prolonged prothrombin time, eosinophilia, thrombocytopenia, vaginal moniliasis, vaginitis, leukorrhea.
","Pregnancy: Tigecycline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: Caution should be exercised when Tigecycline is administered to a nursing woman.
","Tigecycline is structurally similar to Tetracycline-class antibiotics and should be administered with caution in patients with known hypersensitivity to Tetracycline-class antibiotics
",,"No specific information is available on the treatment of overdosage with Tigecycline. Intravenous administration of Tigecycline at a single dose of 300 mg over 60 minutes in healthy volunteers resulted in an increased incidence of nausea and vomiting.
",,"Each vial of Tigecycline should be reconstituted with 5.3 ml of 0.9% Sodium Chloride Injection to achieve a concentration of 10 mg/ml of Tigecycline. The vial should be gently swirled until the drug dissolves. Withdraw 5 ml of the reconstituted solution from the vial and add to a 100 ml intravenous bag of 0.9% Sodium Chloride or 5% Dextrose for infusion (for a 100 mg dose, reconstitute two vials; for a 50 mg dose, reconstitute one vial). The maximum concentration of IV solution should be 1 mg/ml. If the same intravenous line is used for sequential infusion of several drugs, the line should be flushed before and after infusion of Tigecycline with either 0.9% Sodium Chloride Injection or 5% Dextrose Injection.
Tigecycline is compatible with the following IV fluid: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Lactated Ringer’s Injection.
","Prior to reconstitution, Tigecycline should be stored at 20°C to 25°C. Once reconstituted, Tigecycline may be stored at room temperature for up to 24 hours (up to 6 hours in the vial and the remaining time in the intravenous bag). Reconstituted solution may be stored refrigerated at 2°C to 8°C for up to 48 hours following immediate transfer of reconstituted solution into the intravenous bag.
",12
+1069,Tiemonium Methylsulphate,tiemonium-methylsulphate-1069,,Anticholinergics,Visceral muscle spasm,"Tiemonium Methylsulphate is an antispasmodic drug that reduces muscles spasm of the intestine, biliary system, bladder and uterus. It is used in symptomatic treatment of pain related to functional disorders of the digestive tract and biliary system. It is also indicated for the treatment of spasm and pain in urological and gynaecological diseases.
","Anticholinergics
","Tiemonium Methylsulphate a competitive antagonist of Acetylcholine, Histamine and strengthens of calcium bond with membrane phospholipids and proteins. Thus inhibits intracellular contractile protein of visceral cell which causes inhibition of visceral spasm and pain.
","Tablet/Syrup-
+
+- Adult: usual dose is 2-6 tablets or 3-9 teaspoonfuls syrup daily in divided doses.
+- Children: 3 ml/kg or 6 mg/kg body weight daily in divided doses.
+
+
Injection: 1 Tiemonium Methylsulphate Injection 3 times daily, through Intravenous route slowly or Intramuscular route.
Suppository: 20 mg Tiemonium Methylsulphate suppository two or three times daily, through rectal route.
",,"Tiemonium methylsulphate tablet should not be used with other drugs without prior consult of a registered physician to avoid possible drug interaction.
","It should not be used in urethroprostatic disorder involving a risk of urine retension. It is contraindicated in patient with having risk of angle closure glaucoma.
","Tiemonium Methylsulphate may have the risk of hypotension & tachycardia in certain individuals.
","The results of animal studies of Tiemonium Methylsulphate did not reveal any teratogenic effects; no deformities have been reported up till now with normal use. In absence of sufficient data, prudence should be the rule for nursing mothers although no problems have been reported with normal use.
","Caution should be taken during treatment of patients with disorders of the prostate. Caution should also be taken in case of chronic bronchitis, coronary insufficiency, ambient hyperthermia, renal & hepatic insufficiency. The risks of visual disturbances can make it dangerous to drive or use machines.
","Paediatric use: safety and effectiveness of Tiemonium methylsulphate in paediatric patients have not been established.
Geriatric use: Efficacy and safety were maintained with increasing age.
","There is not available data regarding the overdose of Tiemonium methylsulphate tablet.
",,,"Keep in a dry place, away from light and heat. Keep out of the reach of children.
",12
+1279,Ticlopidine Hydrochloride,ticlopidine-hydrochloride-1279,https://medex.com.bd/attachments/L5FAtFtVFFNLQHB8xgKvxKO51G5SU0/ticlopidine-hydrochloride-prescribing-information,Fibrinolytics (Thrombolytics),Stroke,"Ticlopidine is indicated to reduce the risk of thrombotic stroke (fatal or nonfatal) in patients who have experienced stroke precursors, and in patients who have had a completed thrombotic stroke. Because Ticlopidine is associated with a risk of life-threatening blood dyscrasias including thrombotic ... Read more
Ticlopidine is indicated to reduce the risk of thrombotic stroke (fatal or nonfatal) in patients who have experienced stroke precursors, and in patients who have had a completed thrombotic stroke. Because Ticlopidine is associated with a risk of life-threatening blood dyscrasias including thrombotic thrombocytopenic purpura (TTP), neutropenia/ agranulocytosis and aplastic anemia. Ticlopidine should be reserved for patients who are intolerant or allergic to aspirin therapy or who have failed aspirin therapy.
Ticlopidine is also indicated as an adjunctive therapy with aspirin to reduce the incidence of subacute stent thrombosis in patients undergoing successful coronary stent implantation
","Anti-platelet drugs, Fibrinolytics (Thrombolytics)
","When taken orally, Ticlopidine hydrochloride causes a time- and dose-dependent inhibition of both platelet aggregation and release of platelet granule constituents, as well as a prolongation of bleeding time. The intact drug has no significant in vitro activity at the concentrations attained in vivo; and, although analysis of urine and plasma indicates at least 20 metabolites, no metabolite which accounts for the activity of ticlopidine has been isolated.
Ticlopidine hydrochloride, after oral ingestion, interferes with platelet membrane function by inhibiting ADP-induced platelet-fibrinogen binding and subsequent platelet-platelet interactions. The effect on platelet function is irreversible for the life of the platelet, as shown both by persistent inhibition of fibrinogen binding after washing platelets ex vivo and by inhibition of platelet aggregation after resuspension of platelets in buffered medium.
","Stroke: The recommended dose of Ticlopidine is 250 mg bid taken with food. Other doses have not been studied in controlled trials for these indications.
Coronary Artery Stenting: The recommended dose of Ticlopidine is 250 mg bid taken with food together with antiplatelet doses of aspirin for up to 30 days of therapy following successful stent implantation.
",,"Reduced clearance with cimetidine; corticosteroid may antagonise effects on bleeding time. Avoid concurrent use with clopidogrel.
","The use of Ticlopidine is contraindicated in the following conditions:
+
+- Hypersensitivity to the drug
+- Presence of hematopoietic disorders such as neutropenia and thrombocytopenia or a past history of either TTP or aplastic anemia
+- Presence of a hemostatic disorder or active pathological bleeding (such as bleeding peptic ulcer or intracranial bleeding)
+- Patients with severe liver impairment
+
","Diarrhoea, nausea, dyspepsia, bleeding, pupura, skin rash, increase in serum cholesterol concentration, elevation of LFTs, hepatitis, cholestatic jaundice.
","Pregnancy Category B. Teratology studies have been conducted in mice (doses up to 200 mg/kg/day), rats (doses up to 400 mg/kg/day) and rabbits (doses up to 200 mg/kg/day). Doses of 400 mg/kg in rats, 200 mg/kg/day in mice and 100 mg/kg in rabbits produced maternal toxicity, as well as fetal toxicity, but there was no evidence of a teratogenic potential of ticlopidine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of a human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers: Studies in rats have shown ticlopidine is excreted in the milk. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ticlopidine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","Patients with increased risk of bleeding from trauma, surgery or pathological disorder. Moderate to severe renal impairment. May need to stop therapy 10-14 days before elective surgery. Full blood counts should be performed prior to therapy and every 2 wk during the first 3 mth of treatment. Pregnancy.
","Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: Clearance of ticlopidine is somewhat lower in elderly patients and trough levels are increased. The major clinical trials with Ticlopidine in stroke patients were conducted in an elderly population with an average age of 64 years. Of the total number of patients in the therapeutic trials, 45% of patients were over 65 years old and 12% were over 75 years old. No overall differences in effectiveness or safety were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Renal Impairment: Dose reduction or discontinuance if haemorrhagic or haematopoietic complications occur.
Hepatic Impairment: Severe: contraindicated.
","One case of deliberate overdosage with Ticlopidine has been reported by a foreign postmarketing surveillance program. A 38-year-old male took a single 6000-mg dose of Ticlopidine (equivalent to 24 standard 250-mg tablets). The only abnormalities reported were increased bleeding time and increased SGPT. No special therapy was instituted and the patient recovered without sequelae.
Single oral doses of ticlopidine at 1600 mg/kg and 500 mg/kg were lethal to rats and mice, respectively. Symptoms of acute toxicity were GI hemorrhage, convulsions, hypothermia, dyspnea, loss of equilibrium and abnormal gait.
",,,"Store at 15° to 30° C
",12
+1068,Ticagrelor,ticagrelor-1068,https://medex.com.bd/attachments/Z7W21pMppA0YMB86IF96hOhTyD7sa2/ticagrelor-prescribing-information,Anti-platelet drugs,With percutaneous coronary intervention or coronary artery bypass graft,"Ticagrelor is indicated for the prevention of atherothrombotic events in adult patients with Acute Coronary Syndromes (unstable angina, non ST elevation Myocardial Infarction [NSTEMI] or ST elevation Myocardial Infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG).
","Anti-platelet drugs
","Ticagrelor is a selective adenosine diphosphate (ADP) receptor antagonist acting on the P2Y12 ADP-receptor that can prevent ADP-mediated platelet activation and aggregation. Ticagrelor reversibly interacts with the platelet P2Y12 ADP-receptor.Ticagrelor does not interact with the ADP binding site itself, but interacts with platelet P2Y12 ADP-receptor to prevent signal transduction.Thus it prevents platelet activation & aggregation.
","Ticagrelor treatment should be initiated with a single 180 mg loading dose (two tablets of 90 mg) and then continued at 90 mg twice daily. Patients taking Ticagrelor should also take aspirin daily, unless specifically contraindicated. Following an initial dose of aspirin (usually 325 mg), Ticagrelor should be used with a maintenance dose of aspirin of 75-100 mg. Maintenance dose of Aspirin above 100 mg decreased the efficacy of Ticagrelor. So, maintenance dose of aspirin above 100 mg should be avoided.
A patient who misses a dose of Ticagrelor should take only one 90 mg tablet (the next dose) at its scheduled time. Patients treated with Clopidogrel can be directly switched to Ticagrelor if needed. Switching from prasugrel to ticagrelor has not been investigated.
Treatment is recommended for up to 12 months unless discontinuation of Ticagrelor is clinically indicated. Ticagrelor can be administered with or without food.
",,"CYP3A inhibitors: Avoid use of strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromycin).
CYP3A inducers: Avoid use with potent inducers of CYP3A (e.g., rifampin, dexamethasone, phenytoin,carbamazepine and phenobarbital).
Aspirin: Use of Ticagrelor with aspirin maintenance doses above 100 mg reduced the effectiveness ofTicagrelor.
Simvastatin, Lovastatin: Ticagrelor will result in higher serum concentrations of simvastatin and lovastatin because these drugs are metabolized by CYP3A4. Avoid simvastatin and lovastatin doses greater than 40 mg.
Digoxin: Because of inhibition of the P-glycoprotein transporter, monitor digoxin levels with initiation of or any change in ticagrelor therapy.
Other Concomitant Therapy: Ticagrelor can be administered with unfractionated or low-molecular-weight heparin, GPIIb/llla inhibitors, proton pump inhibitors, beta-blockers, angiotensin converting enzyme inhibitors, and angiotensin receptor blockers.
","Ticagrelor is contraindicated in case of-
+
+- Hypersensitivity to Ticagrelor or to any of the excipients
+- Active pathological bleeding (peptic ulcer)
+- History of intracranial haemorrhage
+- Moderate to severe hepatic impairment
+- Co-administration of Ticagrelor with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir)
+
","Dyspnea,bleeding,headache,cough,dizziness,nausea,atrial fibrillation, hypertension, non-cardiac chest pain, diarrhea, back pain, hypotension, fatigue, chest pain.
","Pregnancy category C. There are no or limited amount of data from the use of Ticagrelor in pregnant women.Ticagrelor is not recommended during pregnancy.
Nursing mothers: Available pharmacodynamic/toxicological data in animals have shown excretion of Ticagrelor and its active metabolites in milk. A risk to newborns/infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from ticagrelor therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the women.
","General Risk of Bleeding: Drugs that inhibit platelet function including Ticagrelor increase the risk of bleeding.
Concomitant Aspirin Maintenance Dose: Use of Ticagrelor with maintenance doses of aspirin above 100 mg decreased the effectiveness of Ticagrelor. Therefore, after the initial loading dose of aspirin (usually 325 mg), use Ticagrelor with a maintenance dose of aspirin of 75-100 mg.
Moderate Hepatic Impairment: Ticagrelor has not been studied in patients with moderate hepatic impairment.
Discontinuation of Ticagrelor: Discontinuation of Ticagrelor will increase the risk of myocardial infarction, stent thrombosis, and death.
","Pediatric Use: The safety and effectiveness of Ticagrelor in pediatric patients have not been established.
Geriatric Use: No overall differences in safety or effectiveness were observed in geriatric patients.
Hepatic Impairment: Ticagrelor has not been studied in the patients with moderate or severe hepatic impairment. Ticagrelor is metabolized by the liver and impaired hepatic function can increase risks for bleeding and other adverse events. Hence,
Renal Impairment: No dosage adjustment is needed in patients with renal impairment. Patients receiving dialysis have not been studied.
","There is currently no known antidote to reverse the effects ofTicagrelor and it is not expected to be dialysable.Treatment of overdose should follow local standard medical practice.The expected effect of excessive ticagrelor dosing is prolonged duration of bleeding risk associated with platelet inhibition. If bleeding occurs appropriate supportive measures should be taken.
",,,"Protect from light & moisture. Store below 25° C. Keep out of reach of children.
",12
+1067,Tibolone,tibolone-1067,https://medex.com.bd/attachments/uFFNWquai7fFfFRrf8KObJamcMvFYy/tibolone-prescribing-information,Drugs for menopausal symptoms: Hormone replacement therapy,Vaginal dryness,"Treatment of symptoms resulting from the natural or surgical menopause in post menopausal women. Prevention of osteoporosis in women who have gone through the menopause and are at high risk of fractures, but cannot take other medicines used to prevent osteoporosis.
","Drugs for menopausal symptoms: Hormone replacement therapy
","Tibolone is a synthetic steroid that has estrogenic, androgenic and progestagenic properties. After oral administration, Tibolone is rapidly metabolized into three compounds which contribute to the pharmacological effects of Tibolone. Two of these metabolites (the 3α−OH and 3β−OH metabolite) have predominantly estrogenic activity; a third metabolite (δ4-isomer of Tibolone) and the parent compound have predominantly progestagenic and androgenic activities. Tibolone substitutes for the loss of estrogen production in postmenopausal women and alleviates menopausal symptoms. It prevents bone loss following menopause or ovariectomy. It has estrogenic effects on the vagina, on bone and on the thermoregulatory centers in the brain (hot flushes). It improves vaginal dryness and vaginal atrophy. Tibolone has also effects on mood and libido.
","The dose is one Tibolone tablet per day (2.5 mg daily). The tablet should be swallowed with some water or other drink, preferably at the same time in each day. Improvement of symptoms generally occurs within a few weeks, but optimal results are obtained when therapy is continued for at least 3 months.
Starting Tibolone Tablet: Women experiencing a natural menopause should commence treatment with Tibolone tablet at least 12 months after their last natural bleed. In case of a surgical menopause, treatment with Tibolone tablet may commence immediately.
Switching from a sequential or continuous combined HRT (Hormone Replacement Therapy) preparation: If changing from a sequential HRT preparation, treatment with Tibolone should start the day following completion of the prior regimen. If changing from a continuous-combined HRT preparation, treatment can start at any time.
Missed dose: A missed dose should be taken as soon as remembered, unless it is more than 12 hours overdue. In the later case, the missed dose should be skipped and the next dose should be taken at the normal time. Missing a dose may increase the likelihood of breakthrough bleeding and spotting
",,"No examples of interactions between Tibolone and other medicines have been reported in clinical practice. However, the following potential interactions should be considered on a theoretical basis: Enzyme-inducing compounds such as barbiturates, carbamazepine, hydantoins, and rifampicin may enhance the metabolism of Tibolone and thus decrease its therapeutic effect. Since Tibolone may increase blood or fibrinolytic activity (lower fibrinogen levels; higher AT III, plasminogen, and fibrinolytic activity values), it may enhance the effect of anticoagulants.
","Contraindicated in pregnancy and lactation, known or suspected hormone-dependent tumours, cardiovascular or cerebrovascular disorders, active deep vein thrombosis, thromboembolic disorders, vaginal bleeding of unknown etiology and severe liver disorders.
","Occasionally, vaginal bleeding or spotting may occur, mainly during the first months of treatment. Other adverse effects are headache and migraine, oedema, dizziness, pruritus, increase in body weight, nausea, abdominal pain, rash, and depression.
","Tibolone tablet is contraindicated during pregnancy. If pregnancy occurs during medication with this tablet, treatment should be withdrawn immediately. For this tablet no clinical data on exposed pregnancies are available. Tibolone tablet is contraindicated in lactating women.
","In patients with renal dysfunction, history of liver disease, epilepsy, migraine, hypercholesterolemia, impaired carbohydrate metabolism, diabetes mellitus and cholestatic jaundice.
",,"The acute toxicity of Tibolone in animals is very low. Therefore, toxic symptoms are not expected to occur if several tablets are taken simultaneously. In cases of acute overdose - nausea, vomiting, and withdrawal bleeding in females may develop. Symptomatic treatment can be given if necessary.
",,,"Keep in a cool & dry place. Protect from light. Keep out of the reach of children.
",11
+1874,Thymus Vulgaris Extracts,thymus-vulgaris-extracts-1874,,Miscellaneous topical agents,Intimate hygiene wash,"Active protection for high-risk moments. Intimate hygiene wash with Thymus vulgaris extracts for a natural antibacterial and antifungal action.
Who should use it?
+
+- Women having periods
+- Expectant Mothers
+- New Mothers
+- In situations where there is a risk of infections (swimming-pools, gyms, beaches and surgical procedures)
+
","Miscellaneous topical agents
","It ensures the natural antibacterial and antifungal action of Thymus vulgaris, a plant extracts with marked selective antibacterial properties. Its pH 3.5 is the way to restore the acid environment that might have been altered in the vagina and protect the good vaginal flora.
",,,,"Hypersensitivity to the active substance or to any of the excipients.
",,,,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",5
+1866,Thiotepa,thiotepa-1866,https://medex.com.bd/attachments/faOs70IfsRszPtHVjWKyNGrFyannvM/thiotepa-prescribing-information,Haematopoietic Agents,Allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT),"Thiotepa is indicated, in combination with other chemotherapy medicinal products:
+
+- With or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;
... Read more
Thiotepa is indicated, in combination with other chemotherapy medicinal products:
+
+- With or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;
+- When high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.
+
","Haematopoietic Agents
","Thiotepa is a polyfunctional cytotoxic agent related chemically and pharmacologically to the nitrogen mustard. The radiomimetic action of thiotepa is believed to occur through the release of ethylene imine radicals that, as in the case of irradiation therapy, disrupt the bonds of DNA, e.g. by alkylation of guanine at the N-7, breaking the linkage between the purine base and the sugar and liberating alkylated guanine.
","Adults-
Autologous HPCT:
+
+- Haematological diseases: The recommended dose in haematological diseases ranges from 125 mg/m2/day (3.38 mg/kg/day) to 300 mg/m2/day (8.10 mg/kg/day) as a single daily infusion, administered from2up to 4 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 900 mg/m2(24.32 mg/kg), during the time of the entire conditioning treatment.
+- Lymphoma: The recommended dose ranges from 125 mg/m2/day (3.38 mg/kg/day) to 300 mg/m2/day (8.10 mg/kg/day) as a single daily infusion, administered from2up to 4 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 900 mg/m2(24.32 mg/kg), during the time of the entire conditioning treatment.
+- Central nervous system lymphoma: The recommended dose is 185 mg/m2/day (5 mg/kg/day) as a single daily infusion, administered for 2 consecutive days before autologous HPCT, without exceeding the total maximum cumulative dose of 370 mg/m2(10 mg/kg), during the time of the entire conditioning treatment.
+- Multiple myeloma: The recommended dose ranges from 150 mg/m2/day (4.05 mg/kg/day) to 250 mg/m2/day (6.76 mg/kg/day) as a single daily infusion, administered for 3 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 750 mg/m2(20.27 mg/kg), during the time of the entire conditioning treatment.
+
+
Solid tumours: The recommended dose in solid tumours ranges from 120 mg/m2/day (3.24 mg/kg/day) to 250 mg/m2/day (6.76 mg/kg/day) divided in one or two daily infusions, administered from2up to 5 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 800 mg/m2(21.62 mg/kg), during the time of the entire conditioning treatment.
+
+- Breast cancer: The recommended dose ranges from 120 mg/m2/day (3.24 mg/kg/day) to 250 mg/m2/day (6.76 mg/kg/day) as a single daily infusion, administered from 3 up to 5 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 800 mg/m2(21.62 mg/kg), during the time of the entire conditioning treatment.
+- CNS tumours: The recommended dose ranges from 125 mg/m2/day (3.38 mg/kg/day) to 250 mg/m2/day (6.76 mg/kg/day) divided in one or two daily infusions, administered from 3 up to 4 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 750 mg/m2(20.27 mg/kg), during the time of the entire conditioning treatment.
+- Ovarian cancer: The recommended dose is 250 mg/m2/day (6.76 mg/kg/day) as a single daily infusion, administered in 2 consecutive days before autologous HPCT, without exceeding the total maximum cumulative dose of 500 mg/m2(13.51 mg/kg), during the time of the entire conditioning treatment.
+- Germ cell tumours: The recommended dose ranges from 150 mg/m2/day (4.05 mg/kg/day) to 250 mg/m2/day (6.76 mg/kg/day) as a single daily infusion, administered for 3 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 750 mg/m2(20.27 mg/kg), during the time of the entire conditioning treatment.
+
+Allogeneic HPCT:
+
+- Haematological diseases: The recommended dose in haematological diseases ranges from 185 mg/m2/day (5 mg/kg/day) to 481 mg/m2/day (13 mg/kg/day) divided in one or two daily infusions, administered from 1 up to 3 consecutive days before allogeneic HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 555 mg/m2(15 mg/kg), during the time of the entire conditioning treatment.
+- Lymphoma: The recommended dose in lymphoma is 370 mg/m2/day (10 mg/kg/day) divided in two daily infusions before allogeneic HPCT, without exceeding the total maximum cumulative dose of 370 mg/m2(10 mg/kg), during the time of the entire conditioning treatment.
+- Multiple myeloma: The recommended dose is 185 mg/m2/day (5 mg/kg/day) as a single daily infusion before allogeneic HPCT, without exceeding the total maximum cumulative dose of 185 mg/m2(5 mg/kg), during the time of the entire conditioning treatment.
+- Leukaemia: The recommended dose ranges from 185 mg/m2/day (5 mg/kg/day) to 481 mg/m2/day (13 mg/kg/day) divided in one or two daily infusions, administered from 1 up to 2 consecutive days before allogeneic HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 555 mg/m2(15 mg/kg), during the time of the entire conditioning treatment.
+- Thalassemia: The recommended dose is 370 mg/m2/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT, without exceeding the total maximum cumulative dose of 370 mg/m2(10 mg/kg), during the time of the entire conditioning treatment.
+
",,"Live virus and bacterial vaccines must not be administered to a patient receiving an immunosuppressive chemotherapeutic agent and at least three months must elapse between discontinuation of therapy and vaccination.
Thiotepa appears to be metabolised via CYP2B6 and CYP3A4. Co-administration with inhibitors of CYP2B6 (for example clopidogrel and ticlopidine) or CYP3A4 (for example azole antifungals, macrolides like erythromycin, clarithromycin, telithromycin, and protease inhibitors) may increase the plasma concentrations of thiotepa and potentially decrease the concentrations of the active metabolite TEPA. Co-administration of inducers of cytochrome P450 (such as rifampicin, carbamazepine, phenobarbital) may increase the metabolism of thiotepa leading to increased plasma concentrations of the active metabolite. Therefore, during the concomitant use of thiotepa and these medicinal products, patients should be carefully monitored clinically.
Thiotepa is a weak inhibitor for CYP2B6, and may thereby potentially increase plasma concentrations of substances metabolised via CYP2B6, such as ifosfamide, tamoxifen, bupropion, efavirenz and cyclophosphamide. CYP2B6 catalyzes the metabolic conversion of cyclophosphamide to its active form 4-hydroxycyclophosphamide (4-OHCP) and co-administration of thiotepa may therefore lead to decreased concentrations of the active 4 OHCP. Therefore, a clinical monitoring should be exercised during the concomitant use of thiotepa and these medicinal products.
","Hypersensitivity to the active substance. Pregnancy and lactation. Concomitant use with yellow fever vaccine and with live virus and bacterial vaccines.
",,"There are no data on the use of thiotepa during pregnancy. In pre-clinical studies thiotepa, as most alkylating agents, has been shown to cause embryofoetal lethality and teratogenicity. Therefore, thiotepa is contraindicated during pregnancy. It is unknown whether thiotepa is excreted in human milk. Due to its pharmacological properties and its potential toxicity for breast-fed newborns/infants, breastfeeding is contraindicated during treatment with thiotepa.
","The consequence of treatment with thiotepa at the recommended dose and schedule is profound myelosuppression, occurring in all patients. Severe granulocytopenia, thrombocytopenia, anaemia or any combination thereof may develop. Frequent complete blood counts, including differential white blood cell counts, and platelet counts need to be performed during the treatment and until recovery is achieved. Platelet and red blood cell support, as well as the use of growth factors such as Granulocyte- colony stimulating factor (G-CSF), should be employed as medically indicated. Daily white blood cell counts and platelet counts are recommended during therapy with thiotepa and after transplant for at least 30 days.
","Renal impairment: Studies in renally impaired patients have not been conducted. As thiotepa and its metabolites are poorly excreted in the urine, dose modification is not recommended in patients with mild or moderate renal insufficiency. However, caution is recommended.
Hepatic impairment: Thiotepa has not been studied in patients with hepatic impairment. Since thiotepa is mainly metabolized through the liver, caution needs to be exercised when thiotepa is used in patients with pre-existing impairment of liver function, especially in those with severe hepatic impairment. Dose modification is not recommended for transient alterations of hepatic parameters.
Elderly: The administration of thiotepa has not been specifically investigated in elderly patients. However, in clinical studies, a proportion of patients over the age of 65 received the same cumulative dose as the other patients. No dose adjustment was deemed necessary.
","There is no experience with overdoses of thiotepa. The most important adverse reactions expected in case of overdose is myeloablation and pancytopenia. There is no known antidote for thiotepa. The haematological status needs to be closely monitored and vigorous supportive measures instituted as medically indicated.
",,,"Store and transport refrigerated (2°C-8°C). Do not freeze.
",11
+1065,Thioridazine,thioridazine-1065,,Phenothiazine drugs,Schizophrenia,"Thioridazine is indicated for the management of schizophrenic patients who fail to respond adequately to treatment with other antipsychotic drugs. Due to the risk of significant, potentially life-threatening, proarrhythmic effects with thioridazine treatment, thioridazine should be used only in ... Read more
Thioridazine is indicated for the management of schizophrenic patients who fail to respond adequately to treatment with other antipsychotic drugs. Due to the risk of significant, potentially life-threatening, proarrhythmic effects with thioridazine treatment, thioridazine should be used only in patients who have failed to respond adequately to treatment with appropriate courses of other antipsychotic drugs, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs. Consequently, before initiating treatment with thioridazine, it is strongly recommended that a patient be given at least 2 trials, each with a different antipsychotic drug product, at an adequate dose, and for an adequate duration.
However, the prescriber should be aware that thioridazine has not been systematically evaluated in controlled trials in treatment refractory schizophrenic patients and its efficacy in such patients is unknown.
","Phenothiazine drugs, Phenothiazine related drugs
","Thioridazine is a piperidine phenothiazine which blocks postsynaptic mesolimbic dopaminergic receptors in the brain. It exhibits a strong α-adrenergic blocking effect and depresses the release of hypothalamic and hypophyseal hormones.
","Since thioridazine is associated with a dose-related prolongation of the QTc interval, which is a potentially life-threatening event, its use should be reserved for schizophrenic patients who fail to respond adequately to treatment with other antipsychotic drugs. Dosage must be individualized and the smallest effective dosage should be determined for each patient
Adults: The usual starting dose for adult schizophrenic patients is 50 to 100 mg three times a day, with a gradual increment to a maximum of 800 mg daily if necessary. Once effective control of symptoms has been achieved, the dosage may be reduced gradually to determine the minimum maintenance dose. The total daily dosage ranges from 200 to 800 mg, divided into two to four doses.
Pediatric: For pediatric patients with schizophrenia who are unresponsive to other agents, the recommended initial dose is 0.5 mg/kg/day given in divided doses. Dosage may be increased gradually until optimum therapeutic effect is obtained or the maximum dose of 3 mg/kg/day has been reached.
",,"May potentiate the effects of CNS depressants (e.g. anaesth, barbiturates, narcotics, opiates, other psychoactive drugs).
","Patients with reduced levels of CYP2D6 isoenzyme, congenital long QT syndrome or history of cardiac arrhythmias; severe CNS depression or comatose states of any cause; hypertensive or hypotensive heart disease of extreme degree. Concomitant use with drugs that prolong QTc interval, CYP2D6 isoenzyme inhibitors and drugs which reduce thioridazine clearance by other mechanisms.
","Tardive dyskinesia; leucopenia, neutropenia, agranulocytosis; drowsiness, pseudoparkinsonism and other extrapyramidal symptoms; dry mouth, blurred vision, constipation, nausea, vomiting, diarrhoea, nasal stuffiness, pallor; galactorrhoea, breast engorgement, amenorrhoea, inhibition of ejaculation, peripheral oedema; dermatitis, skin eruptions. Rarely, nocturnal confusion, hyperactivity, lethargy, psychotic reactions, restlessness, headache, photosensitivity, parotid swelling.
","Pregnancy Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Patient with severe CV disease, narrow-angle glaucoma, Parkinson's disease, seizure disorder. Avoid abrupt withdrawal. Hepatic and renal impairment. Elderly with dementia-related psychosis. Pregnancy and lactation.
","Renal Impairment: Lower initial doses and more gradual dosage increase.
Hepatic Impairment: Lower initial doses and more gradual dosage increase.
","Symptoms: Cardiotoxicity (e.g. prolongation of QT interval and QRS complex).
Management: Symptomatic and supportive treatment with CV (e.g. ECG) monitoring. Establish a patent airway and ensure adequate oxygenation and ventilation. Employ gastric lavage and administer repeated doses of activated charcoal. May include ventricular pacing, defibrillation, admin of IV Mg sulfate, lidocaine, phenytoin or isoproterenol, correction of electrolyte abnormalities and/or acid-base balance to manage arrhythmias. Administer lidocaine with caution as it may increase the risk of developing seizures.
",,,"Store between 15-30° C. Protect from light.
",12
+1064,Thiopental Sodium,thiopental-sodium-1064,https://medex.com.bd/attachments/1E5fUSzmIY6kMklB9yyCxc1LKY68Na/thiopental-sodium-prescribing-information,General (Intravenous) anesthetics,Reduction of raised intracranial pressure,"Thiopental Sodium for Injection is indicated-
+
+- As the sole anesthetic agent for brief (15 minutes) procedures,
+- For induction of anesthesia prior to administration of other anesthetic agents,
+- To supplement regional anesthesia,
+- To provide hypnosis during balanced anesthesia with other agents for analgesia or muscle relaxation,
... Read more
Thiopental Sodium for Injection is indicated-
+
+- As the sole anesthetic agent for brief (15 minutes) procedures,
+- For induction of anesthesia prior to administration of other anesthetic agents,
+- To supplement regional anesthesia,
+- To provide hypnosis during balanced anesthesia with other agents for analgesia or muscle relaxation,
+- For the control of convulsive states during or following inhalation anesthesia, local anesthesia, or other causes,
+- In neurosurgical patients with increased intracranial pressure, if adequate ventilation is provided, and
+- For narcoanalysis and narcosynthesis in psychiatric disorders.
+
","General (Intravenous) anesthetics
","Thiopental, a barbiturate, is used for the induction of anesthesia prior to the use of other general anesthetic agents and for induction of anesthesia for short surgical, diagnostic, or therapeutic procedures associated with minimal painful stimuli. Thiopental is an ultrashort-acting depressant of the central nervous system which induces hypnosis and anesthesia, but not analgesia. It produces hypnosis within 30 to 40 seconds of intravenous injection. Recovery after a small dose is rapid, with some somnolence and retrograde amnesia. Repeated intravenous doses lead to prolonged anesthesia because fatty tissues act as a reservoir; they accumulate Pentothal in concentrations 6 to 12 times greater than the plasma concentration, and then release the drug slowly to cause prolonged anesthesia
Thiopental binds at a distinct binding site associated with a Cl- ionopore at the GABAA receptor, increasing the duration of time for which the Cl- ionopore is open. The post-synaptic inhibitory effect of GABA in the thalamus is, therefore, prolonged.
","Thiopental Injection is administered intravenously normally as a 2.5% w/v solution. On occasions it may be administered as a 5% w/v solution (500 mg in 10 ml). The intravenous injection preparation should be used after reconstitution of the sterile powder with Water for Injections, usually to produce a 2.5% w/v solution.
Premedication: Premedication usually consists of atropine or scopolamine to suppress vagal reflexes and inhibit secretions. In addition, a barbiturate or an opiate is often given. Ideally, the peak effect of these medications should be reached shortly before the time of induction.
Test dose: It is advisable to inject a small ""test"" dose of 25 mg to 75 mg of Thiopental Sodium for Injection to assess tolerance or unusual sensitivity to Thiopental Sodium for Injection, and pausing to observe patient reaction for at least 60 seconds. If unexpectedly deep anesthesia develops or if respiratory depression occurs, consider these possibilities: (1) the patient may be unusually sensitive to Thiopental Sodium for Injection, (2) the solution may be more concentrated than had been assumed, or (3) the patient may have received too much.
Use in anaesthesia: Normal dosage for the induction of anesthesia is 100 mg to 150 mg injected over 10 to 15 seconds. If necessary, a repeat dose of 100 mg to 150 mg may be given after one minute. No fixed dosage recommendations for the intravenous injection can be given, since the dosage will need to be carefully adjusted according to the patient's response. Factors such as age, sex, and weight of the patient should be taken into consideration. Thiopental Sodium reaches effective concentrations in the brain within 30 seconds and anesthesia is normally produced within one minute of an intravenous dose.
+
+- Adult: 100 mg to 150 mg intravenously over 10 to 15 seconds, normally as a 2.5% w/v solution. A repeat dose of 100 mg to 150 mg may be given after one minute. The intravenous injection should be given slowly and the amount given titrated against the patient's response to minimize the risk of respiratory depression or the possibility of over dosage. The average dose for an adult of 70 kg is roughly 200 mg to 300 mg (8 mls to 12 mls of a 2.5% w/v solution) with a maximum of 500 mg.
+- Children: 2 mg/kg to 7 mg/kg bodyweight, intravenously over 10 to 15 seconds, normally as a 2.5% w/v solution. A repeat dose of 2 mg/kg to 7 mg/kg may be given after one minute. The dose is 2 mg/kg to 7 mg/kg based on the patient's response. The dose for children should not exceed 7 mg/kg.
+- Elderly: Smaller adult doses are advisable.
+
+
Use in convulsive states: 75 mg to 125 mg (3 mls to 5 mls of a 2.5% w/v solution) should be given as soon as possible after the convulsion begins. Further doses may be required to control convulsion following the use of a local anesthetic. Other regimens, such as the use of intravenous or rectal diazepam, may be used to control convulsive states.
",,"Possible increase in difficulty in producing anaesthesia in patients taking alcohol or CNS depressants. Additive action with other CNS depressants including sedatives, hypnotics, nitrous oxide or alcohol. Increased hypotension and excitatory effects with phenothiazine antipsychotics. Increased hypnotic effect with antipsychotic. Decreased requirement of thiopental sodium with metoclopramide, sulfisoxazole, aspirin, meprobamate, probenecid and other highly protein bound drugs.
","Absolute Contraindication:
+
+- Absence of suitable veins for intravenous administration
+- Hypersensitivity (allergy) to barbiturates
+- Variegate porphyria (South African) or acute intermittent porphyria
+- Status asthmaticus
+
+Relative Contraindication:
+
+- Severe cardiovascular disease
+- Hypotension or shock
+- Conditions in which the hypnotic effect may be prolonged or potentiated, eg, excessive premedication, Addison's disease, hepatic or renal dysfunction, myxedema, increased blood urea, severe anemia, asthma, myasthenia gravis
+
","Hypersensitivity reactions have been reported. Other adverse reactions to thiopental sodium include the followings: respiratory depression, myocardial depression, cardiac arrhythmias, prolonged somnolence and recovery, hypotension, tachycardia, sneezing, coughing, bronchospasm, laryngospasm and shivering. Anaphylactic reactions have been reported. Symptoms, e.g., urticaria, bronchospasm, vasodilation and edema.
","Pregnancy Category C. Animal reproduction studies have not been conducted with Thiopental. It is also not known whether Thiopental can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Thiopental should be given to a pregnant woman only if clearly needed. Thiopental sodium readily crosses the placental barrier and small amounts may appear in the milk of nursing mothers following administration of large doses.
","A person competent in anesthesia management should be in constant attendance and adequate facilities for support of respiration and circulation should be available when Thiopental Sodium for injection is being used. Thiopental Sodium for Injection should be administered with caution to patients with preexisting hypotension or in conditions where the hypnotic effect may be prolonged or intensified, such as in the presence of liver disease and renal disease.
This product may be habit forming. Keep resuscitative and endotracheal intubation equipment and oxygen readily available. Maintain patency of the airway at all times. Only persons qualified in the use of anesthetics should administer this drug. Avoid extravasations or intra-arterial injection.
",,"Overdosage may occur from too rapid or repeated administration. Too rapid injection may be followed by an alarming fall in blood pressure even to shock levels. Apnoea, occasional laryngospasm, coughing and other respiratory difficulties with excessive or too rapid injections may occur. In the event of suspected or apparent overdosage, the agent should be discontinued.
",,,"Store at controlled room temperature of 15° C to 30° C. Solutions should be freshly prepared and used immediately. Any portion of the contents remaining should be discarded.
",11
+1063,Thiamine Hydrochloride,thiamine-hydrochloride-1063,https://medex.com.bd/attachments/CIDTUKMcxu69SDC97JxrUUZK93LHAj/thiamine-hydrochloride-tablet-prescribing-information,Vitamin-B preparations,Wernicke-Korsakoff syndrome,"Thiamine is specifically used in the treatment of the various manifestations of thiamine deficiency such as Beriberi and Wernick's encephalopathy, neuritis associated with pregnancy and pellagra. Supplementary Thiamine may be indicated prophylactically in conditions where there is low dietary intake ... Read more
Thiamine is specifically used in the treatment of the various manifestations of thiamine deficiency such as Beriberi and Wernick's encephalopathy, neuritis associated with pregnancy and pellagra. Supplementary Thiamine may be indicated prophylactically in conditions where there is low dietary intake or impaired gastro intestinal absorption of thiamine (e.g. alcohol) or where requirements are increased (pregnancy, carbohydrate rich diet).
","Vitamin-B preparations
","Thiamine, in the form of thiamine pyrophosphate, is the coenzyme for decarboxylation of α-ketoglutaric acid. Thiamine deficiency affects the peripheral nervous system, the gastrointestinal tract, and the cardiovascular system. This vitamin is necessary for the optimal growth of infants and children. Thiamine is not stored in the body, and is regularly lost from tissues during short periods of deficiency. In order to maintain normal health, an adequate amount of thiamine is required every day. Deficiency of thiamine leads to fatigue, anorexia, gastrointestinal disturbance, tachycardia, irritability and neurological symptoms. Beriberi, a disease due to vitamin B1 deficiency, is common in alcoholics, in pregnant women receiving an inadequate diet, and in people with malabsorption syndrome, prolonged diarrhoea and hepatic disease.
Thiamine is well absorbed from the gastrointestinal tract and widely distributed throughout the body. Thiamine is rapidly absorbed from the upper small intestine. Thiamine is not stored in the body to any appreciable extent. Excess ingested thiamine appears in urine as intact thiamine or as pyrimidine, which arises from degradation of the thiamine molecule. The plasma half life of thiamine is 24 hours.
","Prophylaxis: 3 to 10 mg daily.
Mild chronic deficiency: 10 to 25 mg daily.
Severe deficiency: 200 to 300 mg daily.
",,"No hazardous drug interactions have been reported. Vitamin B1 acts synergistically with other vitamins of the B-complex group and its potential for causing adverse effects is considerably reduced.
","There is no absolute contraindication but the risk of anaphylaxis is increased by repeated parenteral administration. Mild allergic phenomena, such as sneezing or mild asthma are warning signs that further may give rise to anaphylactic shock. To avoid this possibility it is advisable to start a second course of injection with a dose considerably lower than that previously used. Because of the above, vitamin B1 injection should not be given intravenously except in the case of comatose patients. Once thiamine deficiency is corrected there is no need for parenteral administration or for the administration of amounts in excess of daily requirement.
","Vitamin B1 does not have adverse effects when given orally, but in a few fatal cases anaphylactic reactions have occurred after intravenous administration of large doses (400 mg) in sensitive patients, especially children, and in one case following an intramuscular dose of 125 mg. The risk of such reactions increases with repeated administration of the drug by parenteral route. Transient mild soreness may occur at the site of intramuscular administration
","The drug may be given safely to neonates, children, pregnant and lactating women and elderly patients.
",,,,,,"Thiamine injection should be protected from light and moisture.
",9
+1062,Theophylline,theophylline-1062,https://medex.com.bd/attachments/hh4S0TQERZnz0wzs4FcwIxrjuvTjJX/theophylline-prescribing-information,Bronchodilator,Status asthmaticus,"Theophylline is indicated for the-
+
+- Control of acute asthma.
+- Management of chronic asthma (For both Symptomatic and prophylactic treatment).
+- For controlling nocturnal asthma and early morning wheezing.
+- Management of chronic obstructive lung disease (Chronic bronchitis and emphysema) and acute exacerbation of chronic obstructive lung disease.
+- Control of apnea of pre-maturity.
+
","Bronchodilator, Theophylline & related drugs
","Theophylline is a bronchodilator, structurally classified as a Methylxanthine. Theophylline has two distinct actions in the airways of patients with reversible obstruction; smooth muscle relaxation and suppression of the response of the airways to stimuli. Theophylline also increases the force of contraction of diaphragmatic muscles. The half-life of Theophylline is influenced by a number of known variables. In adult nonsmokers with uncomplicated asthma the half-life ranges from 3 to 9 hours
","The dose of theophylline must be individualized on the basis of peak serum theophylline concentration measurements in order to achieve a dose that will provide maximum potential benefit with minimal risk of adverse effects. Most of the sustained release preparations may be administered every 12 hours in adults while administration every 8 hours may be necessary in some children with markedly rapid hepatic
metabolism of theophylline. The recommended maintenance dose within accepted therapeutic range is as follows :
+
+- 16 years or older: 10 mg/Kg/day (Do not exceed 900 mg/day)
+- 12 years-15 years: 13 mg/Kg/day
+- 9-11 years: 16 mg/Kg/day
+- 1 year-8 years: 24-24 mg/Kg/day
+- 6 months-1 year: 12-18 mg/Kg/day
+- 1-6 months: 10 mg/Kg/day.
+
",,"Theophylline should not be used concurrently with other preparations containing xanthine derivatives. The clearance of theophylline is increased by barbiturates, carbamazepine, lithium, phenytoin, rifampicin and sulphinpyrazone and it may therefore be necessary to increase dosage. On the other hand, the clearance of the drug is reduced by allopurinol, cimetidine, ciprofloxacin, corticosteroids, erythromycin, frusemide, isoprenaline, oral contraceptive and thiabendazole and a reduced dosage may therefore be needed to avoid side effects. Theophylline can potentiate hypokalemia resulting from beta-2-agonist therapy, steroids, diuretics and hypoxia, so serum potassium levels should be monitored in such instances.
","Theophylline is contraindicated in patients with hypersensitivity to Theophylline or any other component of the product.
","Generally side effects are rare at normal dosage. It may include gastrointestinal discomfort, headache, nausea, insomnia and hypotension. CNS stimulation and diuresis may also occur, especially in children.
","It is not known whether Theophylline can cause foetal harm when administered to pregnant woman. Xanthines should be given to a pregnant woman only if clearly needed. Theophylline is excreted into breast milk and may cause irritability or other signs of mild toxicity in nursing human infants. Serious adverse effects in the infant are unlikely unless the mother has toxic serum Theophylline concentrations.
","Careful consideration is needed for various interacting drugs and physiologic conditions that can alter Theophylline clearance. Dosage adjustment is required prior to initiation of Theophylline therapy, prior to increases in Theophylline dose, and during follow up. The dose of Theophylline selected for initiation of therapy should be low and, if tolerated, increased slowly over a period of time.
","Pediatrics use: The clearance of Theophylline is very low in neonates. Careful attention to dosage selection and monitoring of serum Theophylline concentrations are required in pediatric patients.
",,,,"Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.
",11
+1061,Thalidomide,thalidomide-1061,https://medex.com.bd/attachments/smX8TByzSo5ZFsNZzPSx5bgAu6RBZ1/thalidomide-prescribing-information,Immunosuppressant,Severe erythema multiforme (Stevens-Johnson syndrome),"Multiple Myeloma: Thalidomide in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM).
Erythema Nodosum Leprosum: Thalidomide is indicated for the acute treatment of the cutaneous ... Read more
Multiple Myeloma: Thalidomide in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM).
Erythema Nodosum Leprosum: Thalidomide is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). Thalidomide is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis. Thalidomide is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence
","Anti-Leprotic drugs, Immunosuppressant
","Thalidomide is a synthetic glutamic acid derivative immunomodulator with anti-inflammatory, antiangiogenetic, sedative and hypnotic activity.
In patients with erythema nodosum leprosum (ENL) the mechanism of action is not fully understood. Available data from in vitro studies and preliminary clinical trials suggest that the immunologic effects of this compound can vary substantially under different conditions, but may be related to suppression of excessive tumor necrosis factor-alpha (TNF-a) production and down-modulation of selected cell surface adhesion molecules involved in leukocyte migration. For example, administration of thalidomide has been reported to decrease circulating levels of TNF-a in patients with ENL, however, it has also been shown to increase plasma TNF-a levels in HIV-seropositive patients. As a cancer treatment, the drug may act as a VEGF inhibitor.
","Multiple Myeloma: Thalidomide is administered in combination with dexamethasone in 28-day treatment cycles. The dose of Thalidomide is 200 mg administered orally once daily with water, preferably at bedtime and at least 1 hour after the evening meal. The dose of dexamethasone is 40 mg daily administered orally on days 1-4, 9-12, and 17-20 every 28 days.
Patients who develop adverse reactions such as constipation, somnolence, or peripheral neuropathy may benefit by either temporarily discontinuing the drug or continuing at a lower dose. With the abatement of these adverse reactions, the drug may be started at a lower dose or at the previous dose based on clinical judgment.
Erythema Nodosum Leprosum: For an episode of cutaneous ENL, Thalidomide dosing should be initiated at 100 to 300 mg/day, administered once daily with water, preferably at bedtime and at least 1 hour after the evening meal. Patients weighing less than 50 kilograms should be started at the low end of the dose range.
In patients with a severe cutaneous ENL reaction, or in those who have previously required higher doses to control the reaction, Thalidomide dosing may be initiated at higher doses up to 400 mg/day once daily at bedtime or in divided doses with water, at least 1 hour after meals.
In patients with moderate to severe neuritis associated with a severe ENL reaction, corticosteroids may be started concomitantly with Thalidomide. Steroid usage can be tapered and discontinued when the neuritis has ameliorated.
Dosing with Thalidomide should usually continue until signs and symptoms of active reaction have subsided, usually a period of at least 2 weeks. Patients may then be tapered off medication in 50 mg decrements every 2 to 4 weeks.
Patients who have a documented history of requiring prolonged maintenance treatment to prevent the recurrence of cutaneous ENL or who flare during tapering should be maintained on the minimum dose necessary to control the reaction. Tapering off medication should be attempted every 3 to 6 months, in decrements of 50 mg every 2 to 4 weeks.
",,"Thalidomide enhances sedative activity of barbiturates, alcohol, chlorpromazine and reserpine. Avoid use of other drugs that have the potential to cause peripheral neuropathy. Increased risk of thromboembolic events with darbepoetin-alfa and doxorubicin.
","Pregnancy and lactation.
","Severe and irreversible peripheral neuropathy, constipation, dizziness, orthostatic hypotension, drowsiness, somnolence, bradycardia, increase of viral load in HIV-infected patients, hypersensitivity reaction.
","Pregnancy Category X. Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
","All females of childbearing potential must use 2 reliable forms of contraception simultaneously 4 wk before starting therapy, during and 4 wk after therapy is discontinued. Therapy to be stopped immediately if pregnancy occurs. Male: Use of barrier methods of contraception if partner is of child-bearing potential. Do not donate blood or sperm during therapy. Patient should not drive or operate machinery. Discontinue therapy if any skin rash develops. Do not resume therapy if the rash is exfoliative, purpuric, or bullous, or if Stevens-Johnson syndrome or toxic epidermal necrolysis suspected
",,,,,,9
+1481,Tetracycline Hydrochloride (Topical),tetracycline-hydrochloride-topical-1481,https://medex.com.bd/attachments/5CAk3DvC0OykDOyzMwKlTMfrhp0MSj/tetracycline-hydrochloride-topical-prescribing-information,Topical Antibiotic preparations,Minor cuts,"First aid to help prevent skin infection in minor cuts, scrapes, and burns.
","Topical Antibiotic preparations
","Tetracycline passively diffuses through porin channels in the bacterial membrane and reversibly binds to the 30S ribosomal subunit, preventing binding of tRNA to the mRNA-ribosome complex, and thus interfering with protein synthesis.
","Clean the affected area. Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily. May be covered with a sterile bandage.
",,"Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription medicine.
","Do not use
+
+- in eyes
+- over large areas of the body
+- longer than 1 week unless directed by doctor
+
","Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
","Pregnancy: Studies have not been done in humans. In studies in rats and rabbits, chlortetracycline and tetracycline topical preparations have not been shown to cause birth defects or other problems. However, studies in rabbits have shown meclocycline to cause a slight delay in bone formation.
Breast feeding: It is not known whether tetracycline topical preparations pass into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are using any of these medicines and who wish to breast-feed should discuss this with their doctor.
","May be harmful is swallowed. Do not use if allergic to any ingredient listed on this label.
","Pediatric: Tetracycline topical solution has been tested on a limited number of children 11 years of age or older and has not been shown to cause different side effects or problems in children than it does in adults. Although there is no specific information about the use of topical chlortetracycline or topical meclocycline in children, they are not expected to cause different side effects or problems in children than they do in adults.
Geriatric: Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information about the use of topical tetracyclines in the elderly.
",,,,"Keep our of reach of children. If swallowed, get medical help or contact a Poison control Center right away. Keep product refrigerated to preserve its effectiveness and color
",11
+1060,Tetracycline Hydrochloride (Oral),tetracycline-hydrochloride-oral-1060,https://medex.com.bd/attachments/yPGQxZbb0kILeV5dvkNXhZFJ6RLONU/tetracycline-hydrochloride-oral-prescribing-information,Tetracycline group of drugs,Uncomplicated gonorrhoea,"Tetracycline is the drug of choice in the following infections :
+
+- Ricketsial infection (Rocky Mountain spotted fever, endemic and scrub typhus fever and human ehrlichiosis).
+- Mycoplasma pneumoniae infections in adults. Outbreaks of pneumonia caused by this organism are common in barracks and institutions. Most cases occur in children and young adults. Maculopapular rashes, haemolytic anaemia and meningo-encephalitis occur rarely.
... Read more
Tetracycline is the drug of choice in the following infections :
+
+- Ricketsial infection (Rocky Mountain spotted fever, endemic and scrub typhus fever and human ehrlichiosis).
+- Mycoplasma pneumoniae infections in adults. Outbreaks of pneumonia caused by this organism are common in barracks and institutions. Most cases occur in children and young adults. Maculopapular rashes, haemolytic anaemia and meningo-encephalitis occur rarely.
+- Chlamydial Infections: Chlamydia psittaci: This organism is the cause of psittacosis (ornithosis), a systemic illness contracted from infected birds. The pneumonia associated with it may be extensive, and severe systemic upset and death are common.Headache is a prominent early symptom.
+- Non-gonococcal or non specific urethritis: Inflammation of the urethra not resulting from gonococcal, chlamydial, or other specific infectious agents.
+- Lyme disease
+- Brucellosis
+- Miscellaneous infections, including granuloma inguinale, cholera, glanders, relapsing fever and V. vulnifians.
+
+Other common uses of tetracycline include the following:
+
+- Urinary Tract Infections with susceptible organisms (including the acute urethral syndrome in women).
+- Bronchitis in patients with known underlying chronic lung diseases.
+- Pelvic inflammatory disease and other sexually transmitted diseases (STDs) regimen.
+- Travelers diarrhoea.
+- Acne vulgaris
+- Prostatitis.
+- As an alternative agent in the penicillin allergic patient with syphilis.
+- Anaerobic infections with susceptible organisms.
+
","Tetracycline group of drugs
","Tetracycline has its main mechanism of action on protein synthesis, and an energy-dependent active transport system pumps the drug through the inner cytoplasmic membrane of bacteria. Once inside the bacterial cell, Tetracycline binds specifically to the 30s ribosomes and inhibit bacterial protein synthesis.
Many Gram positive aerobic Cocci are susceptible, but many strains of staphylococci, streptococci and even some pneumococci are resistant to Tetracycline. Thus, tetracycline is not the drug of choice in infections due to gram positive aerobes.
Pseudomonas and many Enterobacteriaceae are resistant. Urinary concentrations are adequate for some community - acquired E. coli and consequently, Tetracycline is still used in uncomplicated initial UTIs. Tetracycline is also active against and is the drug of choice for Brucella species, Calymmatobacterium granulomatis, Vibrio cholerae and V. vulnificus.
Tetracycline is also active against anaerobic species of bacteria and since concentrations of the drug are quite high in the gastrointestinal contents, the enteric flora are usually altered by the drug.
Tetracycline is incompletely absorbed from the gastro-intestinal tract, about 60 to 80% of a dose of tetracycline usually being available. It is widely distributed through the body tissues and fluids.
Tetracycline has a half-life of about 12 hours. It is excreted in the urine and in the faeces.
","The usual adult oral dosage of Tetracycline is 1-2 g daily given in 2-4 divided doses. The usual oral dosage of Tetracycline for children older than 8 years of age in 25-50 mg/kg daily given in 2-4 divided doses. Alternatively some clinicians recommended that children should receive 0.6-1.2 g/m2 daily.
Tetracycline should be taken preferably one hour before or 2 hours after meals.
Some specific indications along with some information on dosage is given below:
Acne vulgaris: 250 mg four times daily or 500 mg 12 hourly for 1 week; 125-250 mg for several weeks or months. Duration of therapy is determined by individual progress
Acute staphylococcal infections: 1-2 g daily in divided doses for 10-14 days
Acute streptococcal infections: 1-2 g daily in divided doses for 10 days. Prolonged therapy is needed to avoid risk of rheumatic fever or glomerulonephritis
Amoebiasis: 1 g daily in four divided doses or 500 mg 12 hourly for 7 days. Given in association with amoebicidal agents
Brucellosis: 500 mg four times daily plus 1 g streptomycin twice daily for 1 week ; then 500 mg four times daily (no streptomycin) for 1 week. Prolonged therapy is necessary to avoid relapse
Subacute bacterial endocarditis: 1-2 g daily in divided doses for 6 weeks. Usually given in combination with a bactericidal agent
Syphilis: Total 30-40 g given in divided doses over 10-15 days. Serology and spinal fluid examination should follow the administration of tetracycline
",,"Impaired absorption with antacids containing divalent and trivalent cations (e.g. Al, Ca, Mg), Fe, Zn and Na bicarbonate preparations, kaolin-pectin, bismuth subsalicylate, sucralfate, strontium ranelate, colestipol and colestyramine. May interfere with the bactericidal action of penicillin. May potentiate the effect of anticoagulants. May decrease efficacy of oral contraceptives. Nephrotoxic effects may be exacerbated by diuretics or other nephrotoxic drugs. May increase the hypoglycaemic effect of insulin and sulfonylureas in patients with DM. May increase toxic effects of ergot alkaloids and methotrexate.
","Tetracycline Hydrochloride is contraindicated in patients hypersensitive to any of the member of tetracycline groups, since cross-sensitivity may occur Tetracycline Hydrochloride should be avoided in patients with systemic lupus erythematosus. Tetracycline Hydrochloride is considered to be contraindicated in renal impairment, particularly if severe ; if it must be given, doses should be reduced.
","Teeth and bone: Tetracycline can cause depression of bone growth, permanent graybrown discoloration of the teeth and enamel hypoplasia when given during tooth development (i.e. during the later half of pregnancy, during infancy and in childhood).
Hypersensitivity reactions such as anaphylaxis, urticaria and rashes are uncommon. Photosensitivity reactions consisting of a red rash on areas exposed to intense sunlight can occur with Tetracycline.
Gastrointestinal effects: Epigastric distress and nausea are commonly seen after oral administration, and these symptoms are somewhat dose related. Vomiting can occur.
Accentuated prerenal azotemia: Tetracycline appears to aggravate pre-existing renal failure by inhibiting protein synthesis, which increases the azotemia from amino acid metabolism.
Superinfections with oral and anogenital candidiasis are relatively common in patients taking Tetracycline.
Esophageal ulcerations: In most cases, the patients were taking the capsules with little or no fluid before going to bed. To help minimize this, oral doses should be given with adequate amounts of fluid.
","Tetracycline should not be used during pregnancy because of the risk of hypertoxicity in the mother as well as the effects on the developing foetus. Use in pregnancy potentially during breast-feeding and in children up to the age of 8, or some authorise say 12 years, may result in impaired bone growth and permanent discoloration of the child's teeth.
","Care should be taken if Tetracycline Hydrochloride is given to patients with impaired liver function and high doses should be avoided. Potentiality hepatotoxic drugs (including erythromycin, chloramphenicol, isoniazide and sulphonamides) should not be given concomitantly.
",,,,,"Store between 20-25° C.
",10
+1076,Tetracycline Hydrochloride (Ophthalmic),tetracycline-hydrochloride-ophthalmic-1076,,Ophthalmic antibacterial drugs,Ocular infections,"Tetracycline ointment is indicated as followings-
+
+- Treatment of bacterial conjunctivitis
+- Treatment of trachoma (by preference use oral azithromycin for this indication)
+- Prevention of chlamydial and gonococcal neonatal conjunctivitis
+
","Ophthalmic antibacterial drugs
","Tetracycline exhibits its bacteriostatic action by reversibly binding to the 30S subunits of the ribosome, thus preventing protein synthesis and arresting cell growth. It has a broad spectrum of antimicrobial activity including Chlamydiaceae, Mycoplasma spp., Rickettsia spp., spirochaetes, many aerobic and anaerobic gm+ve and gm-ve pathogenic bacteria and some protozoa.
","Wash the eyes with boiled and cooled water before each application. Use sterile sodium chloride 0.9% for newborns. Apply tetracycline 1% into the conjunctival sac of both eyes:
+
+- Conjunctivitis: one application 2 times daily for 7 days
+- Trachoma: one application 2 times daily for 6 weeks
+- Prevention of neonatal conjunctivitis: one single application immediately after birth
+
",,"Impaired absorption with antacids containing divalent and trivalent cations (e.g. Al, Ca, Mg), Fe, Zn and Na bicarbonate preparations, kaolin-pectin, bismuth subsalicylate, sucralfate, strontium ranelate, colestipol and colestyramine. May interfere with the bactericidal action of penicillin. May potentiate the effect of anticoagulants. May decrease efficacy of oral contraceptives. Nephrotoxic effects may be exacerbated by diuretics or other nephrotoxic drugs. May increase the hypoglycaemic effect of insulin and sulfonylureas in patients with DM. May increase toxic effects of ergot alkaloids and methotrexate.
","Do not use in patients with hypersensitivity to tetracyclines. May cause allergic reactions; stop treatment in the event of a serious reaction.
","Burning, irritation, visual disturbances, superinfections, photosensitivity, hypersensitivity
","Pregnancy Category- D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
","Hepatic impairment. Avoid exposure to sunlight. Periodic evaluation of renal, hepatic and haematological system during prolonged therapy.
",,,,,"Store below 25°C. Keep out of the reach of children. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Do not keep outdated medicine or medicine no longer needed.
",10
+1058,Tetrabenazine,tetrabenazine-1058,https://medex.com.bd/attachments/74TkvQryrsWB7dXchjYHR6UVzHy5fr/tetrabenazine-prescribing-information,Atypical neuroleptic drugs,Moderate to severe tardive dyskinesia,"Tetrabenazine is indicated for the treatment of chorea associated with Huntington's disease.
","Atypical neuroleptic drugs
","Prolongation of the QTc interval has been observed at doses of 50 mg. In rats, it has been observed that tetrabenazine or its metabolites bind to melanin-containing tissues such as the eyes and skin. After a single oral dose of radiolabeled tetrabenazine, radioactivity was still detected in eye and fur at 21 days post dosing.
Tetrabenazine is a reversible human vesicular monoamine transporter type 2 inhibitor (Ki = 100 nM). It acts within the basal ganglia and promotes depletion of monoamine neurotransmitters serotonin, norepinephrine, and dopamine from stores. It also decreases uptake into synaptic vesicles. Dopamine is required for fine motor movement, so the inhibition of its transmission is efficacious for hyperkinetic movement. Tetrabenazine exhibits weak in vitro binding affinity at the dopamine D2 receptor (Ki = 2100 nM).
","General Dosing Considerations:
+The chronic daily dose of Tetrabenazine used to treat chorea associated with Huntington's disease (HD) is determined individually for each patient. When first prescribed, Tetrabenazine therapy should be titrated slowly over several weeks to identify a dose of XENAXINE that reduces chorea and is tolerated. Tetrabenazine can be administered without regard to food.
+Individualization Of Dose:
+Dosing Recommendations Up to 50 mg per day: The starting dose should be 12.5 mg per day given once in the morning. After one week, the dose should be increased to 25 mg per day given as 12.5 mg twice a day. Tetrabenazine should be titrated up slowly at weekly intervals by 12.5 mg daily, to allow the identification of a tolerated dose that reduces chorea. If a dose of 37.5 to 50 mg per day is needed, it should be given in a three times a day regimen. The maximum recommended single dose is 25 mg. If adverse reactions such as akathisia, restlessness, parkinsonism, depression, insomnia, anxiety or sedation occur, titration should be stopped and the dose should be reduced. If the adverse reaction does not resolve, consideration should be given to withdrawing Tetrabenazine treatment or initiating other specific treatment (e.g., antidepressants).
Dosing Recommendations Above 50 mg per day: Patients who require doses of Tetrabenazine greater than 50 mg per day should be first tested and genotyped to determine if they are poor metabolizers (PMs) or extensive metabolizers (EMs) by their ability to express the drug metabolizing enzyme, CYP2D6. The dose of Tetrabenazine should then be individualized accordingly to their status as PMs or EMs
+Extensive and Intermediate CYP2D6 Metabolizers:
+Genotyped patients who are identified as extensive (EMs) or intermediate metabolizers (IMs) of CYP2D6, who need doses of Tetrabenazine above 50 mg per day, should be titrated up slowly at weekly intervals by 12.5 mg daily, to allow the identification of a tolerated dose that reduces chorea. Doses above 50 mg per day should be given in a three times a day regimen. The maximum recommended daily dose is 100 mg and the maximum recommended single dose is 37.5 mg. If adverse reactions such as akathisia, parkinsonism, depression, insomnia, anxiety or sedation occur, titration should be stopped and the dose should be reduced. If the adverse reaction does not resolve, consideration should be given to withdrawing Tetrabenazine treatment or initiating other specific treatment (e.g., antidepressants)",,"Tetrabenazine should not be given with or within 14 days of discontinuation of MAOI therapy. Blocks action of reserpine. Decreases effects of levodopa and worsen parkinsonism. Increased risk of extrapyramidal side effects when given with amantadine, metoclopramide, antipsychotics.
","Tetrabenazine is contraindicated in patients:
+
+- Who are actively suicidal, or in patients with untreated or inadequately treated depression
+- With hepatic impairment
+- Taking monoamine oxidase inhibitors (MAOIs). XENAZINE should not be used in combination with an MAOI, or within a minimum of 14 days of discontinuing therapy with an MAOI
+
","The following serious adverse reactions are Depression, Suicidality Akathisia, restlessness, and agitation, Parkinsonism, Dysphagia, Sedation and somnolence
","Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Tetrabenazine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether Tetrabenazine or its metabolites are excreted in human milk. Since many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants from Tetrabenazine, a decision should be made whether to discontinue nursing or to discontinue Tetrabenazine, taking into account the importance of the drug to the mother.
","May exacerbate symptoms of parkinsonism. Caution to be exercised when driving or performing skilled tasks. Pregnancy.
","Pediatric Use: The safety and efficacy of Tetrabenazine in pediatric patients have not been established.
Geriatric Use: The pharmacokinetics of Tetrabenazine and its primary metabolites have not been formally studied in geriatric subjects.
Hepatic Impairment: Because the safety and efficacy of the increased exposure to Tetrabenazine and other circulating metabolites are unknown, it is not possible to adjust the dosage of Tetrabenazine in hepatic impairment to ensure safe use. The use of Tetrabenazine in patients with hepatic impairment is contraindicated
","Three episodes of overdose occurred in the open-label trials performed in support of registration. Eight cases of overdose with Tetrabenazine have been reported in the literature. The dose of Tetrabenazine in these patients ranged from 100 mg to 1g. Adverse reactions associated with Tetrabenazine overdose include acute dystonia, oculogyric crisis, nausea and vomiting, sweating, sedation, hypotension, confusion, diarrhea, hallucinations, rubor, and tremor.
Treatment should consist of those general measures employed in the management of overdosage with any CNS-active drug. General supportive and symptomatic measures are recommended. Cardiac rhythm and vital signs should be monitored. In managing overdosage, the possibility of multiple drug involvement should always be considered. The physician should consider contacting a poison control center on the treatment of any overdose.
",,,,11
+1075,Tetanus Antitoxin [Equine],tetanus-antitoxin-equine-1075,,"Vaccines, Anti-sera & Immunoglobulin",Tetanus,"To provide temporary passive immunity in the prevention and treatment of tetanus.
","Vaccines, Anti-sera & Immunoglobulin
","This is a sterile clear, faintly yellow or brown liquid of tetanus antitoxin (equine) for human use. It is a preparation containing antitoxic globulins that have the power of specifically neutralizing the toxin formed by Clostridium tetani. It is obtained by fractionation from the serum of horses that have been hyperimmunized against tetanus toxin.
","Prophylaxis of tetanus: Tetanus Antitoxin (equine) should not be used in the routine treatment of traumatic wounds. It is given prophylactically to persons at the risk of tetanus infection by infected wounds or severe wounds. For prophylaxis after injury, non-immune or partially immune persons may be given 3,000 to 5,000 units of tetanus antitoxin subcutaneously or intramuscularly. If 24 hours have passed since the wound occurred, the dose is 3,000 III. In crush wounds or wounds contaminated with soil or other foreign bodies, the dose is 10,000 to 20,000 III. For persons below 30 kg the dosage is 1,500 IU. Active immunization with Adsorbed Tetanus vaccine should be given simultaneously with the use of this preparation or a booster injection of Adsorbed Tetanus vaccine should be given if the patient has previously been immunized.
Treatment: Therapy should be given as soon as possible after the appearance of symptoms of the disease. Therapeutic dose not less than 3000 IU. Depending on the severity, the dose may vary from 50,000 to 100,000 IU of tetanus antitoxin for hospitalized patients given partially by intravenous route and the rest of the dose intramuscularly.
","The solution should be shaken well before use. Please do not shake vigorously. The solution should be inspected visually for particulate matter and discoloration prior to administration. If either of these conditions exists, the solution should not be administered. The solution should be used as supplied; no dilution is necessary. Once the vial is opened, the preperation must be used immediately.
Co-administration: Immunosuppressive therapy should be interrupted when immunization is required because of a tetanus-prone wound.
",,"Injection of the antitoxin to persons with a history of allergic reactions to equine protein and to allergic individuals is contraindicated.
","Hypersensitive reactions may occur after the injection of any serum of animal origin. In rare cases hypotension, dyspnoea, urticaria may occur. It should be treated with adrenalin, possibly in association with antihistamine and corticosteroid therapy. Serum sickness may occur 7 to 10 days after injection of serum of animal origin; symptoms include fever, vomiting, diarrhoea, bronchospasm and urticaria.
","Tetanus antitoxin (equine) must not be administered during pregnancy.
","If there is no history of previous serum injection or allergic reaction, the dose of serum may be given intramuscularly. If the patient is subject to allergic diseases, a trial dose of 0,2 ml (diluted 1:10 if preferred) of the serum should be given subcutaneously; if no general reaction develops during an interval of 30 minutes, the main dose may be given intramuscularly. The patient must be kept under observation for at least 30 minutes after the injection and adrenaline kept in readiness for emergency use. In all urgent cases, the intravenous route is indicated, but should never be used unless a preliminary intramuscular injection, given at least 30 minutes beforehand, has been tolerated. For intravenous use, the serum should be at room temperature, the injection should be given very slowly, and the patient should be recumbent during the injection, and for at least an hour afterwards.
",,"Not applicable.
",,,"Keep out of the reach and sight of children. Store at +2°C to +8°C. Transportation should also be at +2°C to +8 °C. Do not freeze. Discard solution if frozen. Protect from light
",11
+1100,Trastuzumab,trastuzumab-1100,https://medex.com.bd/attachments/q8FhDz3wj7NVLMEymwxV2ZnmS7Vgq9/trastuzumab-prescribing-information,,,"Adjuvant Breast Cancer: Trastuzumab is indicated for adjuvant treatment of HER2 overexpressing node-positive or node-negative ER/PR negative or with one high-risk feature breast cancer
+
+- as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
... Read more
Adjuvant Breast Cancer: Trastuzumab is indicated for adjuvant treatment of HER2 overexpressing node-positive or node-negative ER/PR negative or with one high-risk feature breast cancer
+
+- as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
+- as part of a treatment regimen with docetaxel and carboplatin
+- as a single agent following multi-modality anthracycline-based therapy.
+
+
Metastatic Breast Cancer: Trastuzumab is indicated:
+
+- In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer
+- As a single agent for treatment of HER2-overexpressing breast cancer in a patient who has received one or more chemotherapy regimens for metastatic disease. overexpressing breast cancer in patient.
+
+
Metastatic Gastric Cancer: Trastuzumab is indicated, in combination with cisplatin and
capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing
metastatic gastric or gastroesophageal junction adenocarcinoma who have not received
prior treatment for metastatic disease.
",,"The HER2 (or c-erbB2) proto-oncogene encodes a transmembrane receptor protein of 185 kDa, which is structurally related to the epidermal growth factor receptor. Trastuzumab has been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumor cells that overexpress HER2. Trastuzumab is a mediator of antibody-dependent cellular cytotoxicity (ADCC). In vitro, Trastuzumab-mediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2.
","Recommended Doses and Schedules: Do not administer as an intravenous push or bolus. Do not mix Trastuzumab with other drugs.
Adjuvant Treatment, Breast Cancer: Administer according to one of the following doses and schedules for a total of 52 weeks of Trastuzumab therapy:
During and following paclitaxel, docetaxel, or docetaxel/carboplatin:
+
+- Initial dose of 4 mg/kg as an intravenous infusion over 90 minutes then at 2 mg/kg as an intravenous infusion over 30 minutes weekly during chemotherapy for the first 12 weeks (paclitaxel or docetaxel) or 18 weeks (docetaxel/carboplatin).
+- One week following the last weekly dose of Trastuzumab, administer Trastuzumab at 6 mg/kg as an intravenous infusion over 30−90 minutes every three weeks.
+
+
As a single agent within three weeks following completion of multi-modality, anthracycline-based chemotherapy regimens:
+
+- Initial dose at 8 mg/kg as an intravenous infusion over 90 minutes
+- Subsequent doses at 6 mg/kg as an intravenous infusion over 30−90 minutes every three weeks.
+- Extending adjuvant treatment beyond one year is not recommended
+
+
Metastatic Treatment, Breast Cancer: Administer Trastuzumab, alone or in combination with paclitaxel, at an initial dose of 4 mg/kg as a 90 minute intravenous infusion followed by subsequent once-weekly doses of 2 mg/kg as 30-minute intravenous infusions until disease progression.
Metastatic Gastric Cancer: Administer Trastuzumab at an initial dose of 8 mg/kg as a 90-minute intravenous infusion followed by subsequent doses of 6 mg/kg as an intravenous infusion over 30–90 minutes every three weeks until disease progression. Or, as directed by the registered physician.
","
+- Using a sterile syringe, slowly inject the 20 ml of diluent into the vial containing the lyophilized powder of Trastuzumab, which has a cake-like appearance. The stream of diluent should be directed into the cake. The reconstituted vial yields a solution for multiple-dose use, containing 21 mg/ml Trastuzumab.
+- Swirl the vial gently to aid reconstitution. DO NOT SHAKE.
+- Slight foaming of the product may be present upon reconstitution. Allow the vial to stand undisturbed for approximately 5 minutes.
+- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Inspect visually for particulates and discoloration. The solution should be free of visible particulates, clear to slightly opalescent and colorless to pale yellow.
+- Store reconstituted Trastuzumab in the refrigerator at 2°C to 8°C, discard unused Trastuzumab after 28 days. If Trastuzumab is reconstituted with SWFI without preservative, use immediately and discard any unused portion.
+
","Patients who receive anthracycline after stopping Trastuzumab may be at increased risk of cardiac dysfunction because of Trastuzumab’s long washout period based on population PK analysis. If possible, physicians should avoid anthracycline-based therapy for up to 7 months after stopping Trastuzumab. If anthracyclines are used, the patient’s cardiac function should be monitored carefully.
",,"The most serious adverse reactions caused by Trastuzumab includes Cardiomyopathy, Infusion Reactions, Embryo-Fetal Toxicity, Pulmonary Toxicity, Exacerbation of Chemotherapy-Induced Neutropenia. The most common adverse reactions in patients receiving Trastuzumab in the adjuvant and metastatic breast cancer setting are fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia.
","It can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to the initiation of Trastuzumab. Advise pregnant women and females of reproductive potential that exposure to Trastuzumab during pregnancy or within 7 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of Trastuzumab. There is no information regarding the presence of Trastuzumab in human milk, the effects on the breastfed infant, or the effects on milk production.
","Cardiomyopathy: Trastuzumab can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death. Trastuzumab can also cause asymptomatic decline in left ventricular ejection fraction (LVEF). There is a 4-6 fold increase in the incidence of symptomatic myocardial dysfunction among patients receiving Trastuzumab as a single agent or in combination therapy compared with those not receiving Trastuzumab. The highest absolute incidence occurs when Trastuzumab is administered with an anthracycline. Withhold Trastuzumab for ≥ 16% absolute decrease in LVEF from pre treatment values or an LVEF value below institutional limits of normal and ≥ 10% absolute decrease in LVEF from pretreatment values. The safety of continuation or resumption of Trastuzumab in patients with Trastuzumab-induced left ventricular cardiac dysfunction has not been studied.
Cardiac Monitoring: Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan. The following schedule is recommended:
+
+- Baseline LVEF measurement immediately prior to initiation of Trastuzumab
+- LVEF measurements every 3 months during and upon completion of Trastuzumab
+- Repeat LVEF measurement at 4 week intervals if Trastuzumab is withheld for significant left ventricular cardiac dysfunction.
+- LVEF measurements every 6 months for at least 2 years following completion of Trastuzumab as a component of adjuvant therapy.
+
+
Infusion Reactions: Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion included nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia. Serious and fatal infusion reactions have been reported. Severe reactions, which include bronchospasm, anaphylaxis, angioedema, hypoxia, and severe hypotension, were usually reported during or immediately following the initial infusion. However, the onset and clinical course were variable, including progressive worsening, initial improvement followed by clinical deterioration, or delayed post-infusion events with rapid clinical deterioration. For fatal events, death occurred within hours to days following a serious infusion reaction. Interrupt Trastuzumab infusion in all patients experiencing dyspnea, clinically significant hypotension, and intervention of medical therapy administered (which may include epinephrine, corticosteroids, diphenhydramine, bronchodilators, and oxygen). Patients should be evaluated and carefully monitored until complete resolution of signs and symptoms. Permanent discontinuation should be strongly considered in all patients with severe infusion reactions. There are no data regarding the most appropriate method of identification of patients who may safely be retreated with Trastuzumab after experiencing a severe infusion reaction. Prior to resumption of Trastuzumab infusion, the majority of patients who experienced a severe infusion reaction were pre-medicated with antihistamines and/or corticosteroids. While some patients tolerated Trastuzumab infusions, others had recurrent severe infusion reactions despite pre-medications.
Embryo-Fetal Toxicity: Trastuzumab can cause fetal harm when administered to a pregnant woman. Use of Trastuzumab during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of Trastuzumab.
Pulmonary Toxicity: Trastuzumab use can result in serious and fatal pulmonary toxicity. Pulmonary toxicity includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion reactions. Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity.
Exacerbation of Chemotherapy-Induced Neutropenia: In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving Trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received Trastuzumab and those who did not.
","Pediatric Use: The safety and effectiveness in pediatric patients have not been established.
",,,"Reconstitute each 440 mg vial of Trastuzumab with 20 ml of Bacteriostatic Water for Injection (BWFI), USP, containing 1.1% benzyl alcohol as a preservative to yield a multi-dose solution containing 21 mg/ml Trastuzumab. In patients with known hypersensitivity to benzyl alcohol, reconstitute with 20 ml of Sterille Water for Injection (SWFI) without preservative to yield a single use solution.
","Store the vial in original carton at 2 o -8 o C. Protect from light. Keep out of the reach of children. Store reconstituted Trastuzumab in the refrigerator at 2°C to 8°C, discard unused Trastuzumab after 28 days. If Trastuzumab is reconstituted with SWFI without preservative, use immediately and discard any unused portion. Do not freeze. The solution of Trastuzumab for infusion diluted in 0.9% Sodium Chloride Injection, USP, should be stored at 2°C to 8°C for no more than 24 hours prior to use. Do not freeze.
",11
+1099,Tranexamic Acid,tranexamic-acid-1099,https://medex.com.bd/attachments/Q5zWf5Ilekj3cYAObGmQYQIhIYpxWa/tranexamic-acid-prescribing-information,Anti-fibrinolytic drugs,Uterine bleeding,"In medicine: Prophylaxis and therapy of hemophtoes, digestive hemorrhages, hemorrhagic syndromes in leukaemia, cirrhosis and hemophilia, thrombocytopenic purpura, accidents during thrombolytic therapy and transfusion.
In surgery: Prophylaxis and antihemorrhagic ... Read more
In medicine: Prophylaxis and therapy of hemophtoes, digestive hemorrhages, hemorrhagic syndromes in leukaemia, cirrhosis and hemophilia, thrombocytopenic purpura, accidents during thrombolytic therapy and transfusion.
In surgery: Prophylaxis and antihemorrhagic therapy during operations of any type and nature and particularly in pulmonary, cardiovascular and abdominal surgery and post-operative and traumatic shock.
In urology: Prophylaxis and antihemorrhagic therapy of prostatic, vesical and renal surgery. Hematurias.
In obstetrics: Prophylaxis and therapy of post-partum and puerperium hemorrhages, hemorrhagic metrophathies, functional menometrorrhagias, idiopathic or IUD(lntra uterine Device) induced menorrhagias, primitive hyperfibrinolysis (abruptio placentae, premature placenta detachment) and in cervical conization.
In otorhinolaryngology: Prophylaxis and antihemorrhagic therapy during a tonsillectomy, specialist surgery generally, epistaxis.
In stomatology: Prophylaxis and antihemorrhagic therapy during maxillofacial operations, tooth extractions.
In oncology (as supportive therapy): To promote the formation of a fibrin capsule to wall off and thereby inhibit the growth of ovarian tumors. To cause regression of ascites secondary to carcinoma. To reduce bleeding during surgical interventions.
","Anti-fibrinolytic drugs, Haemostatic drugs
","This is a preparation of tranexamic acid (trans-4 aminomethyl-cyclohexanecarboxylic acid). Tranexamic acid is a substance endowed with a strong antifibrinolytic action and both in vivo and in vitro it has proved to be 10 times more active than conventional hemostatics, depending on the test. The antihemorrhagic action of tranexamic acid is essentially due to an inhibition of the plasminogen activation of both exogenous activators like streptokinase and endogenous ones like urokinase and the plasminogen tissue activator. This fact is particularly important for the clinical use of Tranexamic Acid, because it ensures an antihemorrhagic activity with an antifibrinolytic mechanism under a variety of conditions.
The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.
Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.
","Adults-
+
+- The usual dose: 500-1000 mg 3 times daily.
+- For prophylaxis: The mean recommended daily doses are 0.5-1 gm orally, 500 mg by the parenteral (intravenous or intramuscular) route.
+- For therapy of hemorrhagic manifestations: the oral dose increases to 1-3 gm given in divided doses: in cases of particular seriousness and urgency, begin by injecting an ampoule (500 mg) slowly by intravenous route and administer the necessary subsequent oral doses.
+
+Children-
+
+- For prophylaxis: For every kg of body weight from 5-10 mg are orally administered daily in divided doses.
+- For therapeutic purposes: The oral doses are doubled (from 10 to 20 mg/kg), while the intravenous and intramuscular treatment is begun with 10 mg/kg (=0.5 ml every 5 kg) by the slow intravenous route, continuing the oral administration up to the required dose. Where it is more convenient (e.g. in small babies) the ampoules, diluted in a little sweetened water, maybe orally administered instead of the Capsules.
+
+Elderly patients: No reduction in dosage is necessary unless there is evidence of renal failure.
",,"Tranexamic Acid is a synthetic Amino Acid that is incompatible with solutions containing penicillins (eg: Benzyl penicillin). Thrombolytic drugs like Streptokinase & Urokinase antagonise the antifibrinolytic action of Tranexamic Acid. The potential for thrombus formation may be increased by concomitant administration of estrogen containing drugs, like oral contraceptives. Direct admixture of Tranexamic Acid with whole blood should be avoided during Transfusion.
","Known individual hypersensitivity to the product. Thromboembolic disease, arterial and venous thrombosis, endocavitary hemorrhages, serious kidney failure.
","
+- Tranexamic Acid is generally well tolerated; there may be infrequent cases of sense of fatigue, conjunctival irritation, nasal blockage, itching, skin reddening, exanthems.
+- After oral administration there may be sign of nausea, diarrhea, gastric pyrosis.
+- There are rare cases of postural hypotension.
+- In the case of hypersensitivity to tranexamic acid, avoid or suspend treatment and start a suitable therapy.
+
","Since the transplacental passage of the drug and its possible effects on the fetus are unknown, Tranexamic Acid should not be administered during known and presumed pregnancy. Tranexamic Acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.
","
+- Tranexamic Acid should be used in cases where there is hyperfibrinolysis. The prophylactic treatment must begin 24 hours before the operation and continue until 3-4 days after it.
+- The therapy of hemorrhages must be prolonged for at least 24 hours after manifestations have disappeared.
+- In hematuria, especially when this is not accompanied by any other hemorrhagic manifestations, reduce the doses to prevent formation of clots in the urinary tract.
+- Tranexamic Acid must not be used in serious renal insufficiency or anuric syndromes and must only be used with caution in less serious renal dysfunctions.
+- The administration of product requires particular care in cardiopathic and hepatopathic subjects.
+
",,,,,"Store in a dry place at 15-30°C, away from light and keep out of children's reach.
",10
+1098,Tramadol Hydrochloride,tramadol-hydrochloride-1098,https://medex.com.bd/attachments/pFKgAz2bl4jTlV23s5TY4RmUs8Cn4f/tramadol-hydrochloride-tablet-prescribing-information,Opioid analgesics,Renal colic,"Tramadol is used for the treatment of moderate to severe painful conditions. These include:
+
+- Postoperative pain
+- Colic and spastic pain
+- Cancer pain
+- Joint pain
+- Neck and back pain
+- Pain associated with osteoporosis.
+
","Opioid analgesics
","Tramadol is a centrally acting synthetic analgesic compound. It inhibits the re uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Tramadol are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.
","Capsule or Tablet: Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions an initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4-6 hourly. The dose level and frequency of dosing will depend on the severity of the pain.The total daily dosage by mouth should not exceed 400 mg.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
",,"In general, physician need not be concerned about drugs interacting with Tramadol. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Tramadol. Concomitant administration of carbamazepine with Tramadol causes a significant increase in Tramadol metabolism and it requires to increase the dose of Tramadol.
","Tramadol is contraindicated in persons having hypersensitivity to this drug. It is also contraindicated in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.
","Commonly occurring side-effects are dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhoea. Less commonly occurring side-effects include malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis etc.
","Safe use of Tramadol in pregnancy has not been established. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, Tramadol should be used during pregnancy only if the potential benefit justifies the risk to the foetus. Tramadol Hydrochloride should not be administered during breast feeding as Tramadol and its metabolites have been detected in breast milk.
","Respiratory depression: When large doses of tramadol are administered with anaesthetic with anaesthetic medications or alcohol, respiratory depression may result. Therefore, tramadol should be administered cautiously in patients at risk for respiratory depression.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
","In children from the age of 1 year Tramadol Hydrochloride can be given in a dose of 1-2 mg/kg body weight. However,suppository (100 mg Tramadol Hydrochloride) should not be administered in children and adolescents below the age of 14 years. Tramadol Hydrochloride 100 mg SR Capsules have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+1497,Torsemide,torsemide-1497,https://medex.com.bd/attachments/JRHhyaQ5JmTdb0QgDIdrJoLljVFKJH/torsemide-prescribing-information,Loop diuretics,Oedema,"Torsemide is indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Torsemide is indicated for the treatment of hypertension alone or in combination with other antihypertensive agents.
","Loop diuretics
","Torsemide acts within the lumen of the thick ascending portion of the loop of Henle, where it inhibits the Na+/K+/2CI carrier system. Torsemide increases the urinary excretion of sodium, chloride and water, but it does not significantly alter glomerular filtration rate, renal plasma flow or acid-base balance.
","Edema associated with heart failure: The recommended initial dose is Torsemide 10 mg or 20 mg once daily. If the diuretic response is inadequate, titrate upward by approximately doubling until the desired diuretic response is obtained.
Edema associated with chronic renal failure: The recommended initial dose is Torsemide 20 mg once daily. If the diuretic response is inadequate, titrate upward by approximately doubling until the desired diuretic response is obtained.
Edema associated with hepatic cirrhosis: The recommended initial dose is Torsemide 5 mg or 10 mg once daily, administered together with an aldosterone antagonist or a potassium-sparing diuretic. If the diuretic response is inadequate, titrate upward by approximately doubling until
the desired diuretic response is obtained.
Treatment of Hypertension: The recommended initial dose is 5 mg once daily. If the 5 mg dose does not provide adequate reduction in blood pressure within 4 to 6 weeks, increase to 10 mg once daily. If the response to 10 mg is insufficient, add another antihypertensive agent to the treatment regimen.
",,"Patients receiving high doses of salicylates may experience salicylate toxicity when Torsemide is concomitantly administered. If Torsemide and cholestyramine should be co-administered, administer Torsemide at least one hour before or 4 to 6 h after cholestyramine administration. Also, coadministration of Torsemide with ACE inhibitors or Angiotensin receptor blockers can increase the risk of hypotension and renal impairment.
","Torsemide is contraindicated in patients with known hypersensitivity to Torsemide. It is contraindicated in patients who are anuric or with hepatic coma.
",,"Pregnancy Category: B
Use in Lactation: It is not known whether Torsemide is excreted in human milk. Caution should be exercised when Torsemide is administered to a nursing woman.
","Hypotension: Excessive diuresis may cause potentially symptomatic dehydration, blood volume reduction and hypotension.
Electrolyte and Metabolic Abnormalities: Torsemide can cause symptomatic hypokalemia, hyponatremia and hypochloremic alkalosis.
",,,,,"Protect from light and moisture. Store below 30°C. Keep the medicine out of reach of children.
",9
+1097,Torasemide,torasemide-1097,https://medex.com.bd/attachments/mBPrCK3PKwbJTA2vhuKRcGiGe1BqZA/torasemide-prescribing-information,Loop diuretics,Oedema,"Torasemide is indicated for the management of edema of cardiac, renal and hepatic origin.The management of hypertension, as a sole therapeutic agent or in combination with other classes of antihypertensive agents.
","Loop diuretics
","Torasemide inhibits the Na+/K+/2CI- carrier system (via interference of the chloride binding site) in the lumen of the thick ascending portion of the loop of Henle, resulting in a decrease in reabsorption of sodium and chloride. This results in an increase in the rate of delivery of tubular fluid and electrolytes to the distal sites of hydrogen and potassium ion secretion, while plasma volume contraction increases aldosterone production. The increased delivery and high aldosterone levels promote sodium reabsorption at the distal tubules, and By increasing the delivery of sodium to the distal renal tubule, torasemide indirectly increases potassium excretion via the sodium-potassium exchange mechanism. Torasemide's effects in other segments of the nephron have not been demonstrated. Thus torasemide increases the urinary excretion of sodium, chloride, and water, but it does not significantly alter glomerular filtration rate, renal plasma flow, or acid-base balance. Torasemide's effects as a antihypertensive are due to its diuretic actions. By reducing extracellular and plasma fluid volume, blood pressure is reduced temporarily, and cardiac output also decreases.
","Congestive heart failure: The usual initial oral dose is 10 mg or 20 mg once daily. If the diuretic response is inadequate, the dose should be titrated upward by approximately doubling until the desired diuretic response is obtained. Single doses higher than 200 mg have not been adequately studied.
Chronic renal failure: The usual initial oral dose is 20 mg once daily. lf the diuretic response is inadequate, the dose should be titrated upward by approximately doubling until the desired diuretic response is obtained. Single doses higher than 200mg have not been adequately studied.
Hepatic cirrhosis: The usual initial oral dose is 5 mg or 10 mg once daily, administered together with an aldosterone antagonist or a potassium sparing diuretic. If the diuretic response is inadequate, the dose should be titrated upward by approximately doubling until the desired diuretic response is obtained. Single doses higher than 40 mg have not been adequately studied. Chronic use of any diuretic in hepatic disease has not been studied in adequate and well-controlled trials.
Hypertension: The usual initial oral dose is 2.5-5 mg once daily. If the 5 mg dose does not provide adequate reduction of blood pressure within 4 to 6 weeks, the dose may be increased to 10 mg once daily. If the response to 10 mg is insufficient, an additional antihypertensive should be added to the treatment regimen.
",,"Increased risk of severe hypokalaemia with amphotercin B, corticosteroids, carbenoxolone, hypokalaemia-causing medications. Increased risk of lithium toxicity. Increased potential for ototoxicity and nephrotoxicity with nephrotoxic or ototoxic medications e.g. aminoglycosides. High dose salicylates may increase the risk of salicylate toxicity. Increased risk of toxicity with digoxin. Reduced diuretic effect with NSAIDs. Increased risk of hypotension with antihypertensives.
","Torasemide is contraindicated in patients with known hypersensitivity to torasemide and other sulfonyl ureas. It is also contraindicated in patients who are anuric.
","Usually torasemide is well tolerated. However, a few side effects like dry mouth, dizziness, tiredness, skin rash, diarrhea, constipation, nausea, vomiting, orthostatic hypotention and muscle cramp may occur. All side effects usually are mild and transient.
","Pregnancy: Adequate and well controlled studies of torasemide have not been carried out in pregnant woman. Because animal reproduction studies are not always predictive of human response, torasemide can be used during pregnancy only if clearly needed.
Nursing Mother: lt is not known whether torasemide is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when torasemide is administered to a nursing mother.
","Precautions should be taken while torasemide is administered in the conditions like diabetes, gout, hypotension and liver failure.
","Use in children: Safety and efficacy of torasemide in children have not been established.
","There is no human experience of overdoses of torasemide, but the signs and symptoms of overdosage can be anticipated to be those of excessive pharmacological effect: dehydration, hypovolemia, hypotension and hypokalemia. Treatment of overdose should consist of fluid and electrolyte supplement.
",,,"Store Torasemide at room temperature less than 30° C and keep in cool and dry place, away from moisture and sunlight. Keep the medicine out of the reach of children.
",12
+1295,Topotecan,topotecan-1295,https://medex.com.bd/attachments/RELdmnwbZ3zFqRVVf3JOD8J7uyn7H7/topotecan-prescribing-information,Cytotoxic Chemotherapy,Small cell lung cancer,"Ovarian Cancer: Topotecan for injection, as a single agent, is indicated for the treatment of patients with metastatic carcinoma of the ovary after disease progression on or after initial or subsequent chemotherapy.
Small Cell Lung Cancer: ... Read more
Ovarian Cancer: Topotecan for injection, as a single agent, is indicated for the treatment of patients with metastatic carcinoma of the ovary after disease progression on or after initial or subsequent chemotherapy.
Small Cell Lung Cancer: Topotecan for injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy.
Cervical Cancer: Topotecan for injection in combination with cisplatin is indicated for the treatment of patients with Stage IV-B, recurrent, or persistent carcinoma of the cervix not amenable to curative treatment.
","Cytotoxic Chemotherapy
","Topotecan has the same mechanism of action as irinotecan and is believed to exert its cytotoxic effects during the S-phase of DNA synthesis. Topoisomerase I relieves torsional strain in DNA by inducing reversible single strand breaks. Topotecan binds to the topoisomerase I-DNA complex and prevents religation of these single strand breaks. This ternary complex interferes with the moving replication fork, which leads to the induction of replication arrest and lethal double-stranded breaks in DNA. As mammalian cells cannot efficiently repair these double strand breaks, the formation of this ternary complex eventually leads to apoptosis (programmed cell death).
Topotecan mimics a DNA base pair and binds at the site of DNA cleavage by intercalating between the upstream (-1) and downstream (+1) base pairs. Intercalation displaces the downstream DNA, thus preventing religation of the cleaved strand. By specifically binding to the enzyme–substrate complex, Topotecan acts as an uncompetitive inhibitor.
","Verify dose using body surface area prior to dispensing. Recommended dosage should generally not exceed 4 mg intravenously
Ovarian Cancer: The recommended dose of Topotecan is 1.5 mg/m² by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21-day course.
Small Cell Lung Cancer: The recommended dose of Topotecan is 1.5 mg/m² by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21-day course.
Cervical Cancer: The recommended dose of Topotecan is 0.75 mg/m² by intravenous infusion over 30 minutes daily on Days 1, 2, and 3 in combination with cisplatin 50 mg/m² on Day 1, repeated every 21 days.
",,"Increased clearance with phenytoin. G-CGF to be given 24 hr after completion of treatment with topotecan as concurrent admin may prolong duration of neutropenia. Increased bone marrow supression with other cytotoxic drugs (e.g. cisplatin) so dose reduction may be needed.
","Severe bone marrow depression (e.g. baseline neutrophil count of <1500 cells/mm3 and platelet count <100,000/mm3). Pregnancy, lactation, severe renal or hepatic impairment.
","Neutropenia (nadir of white cell count occurs about 9-12 days after admin), thrombocytopenia and anaemia. GI upset, total alopecia, headache, dyspnoea. Fatigue, weakness, malaise, pruritus and hyperbilirubinaemia.
","Pregnancy category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Preexisting bone marrow depression. Frequent monitoring of peripheral blood cell counts during treatment. Do not continue subsequent courses until neutrophils recover to >1000 cells/mm3, platelets recover to >100,000 cells/mm3 and haemoglobin levels recover to 9.0 g/dl (with transfusion if needed). May impair ability to drive or operate machinery.
","Renal Impairment:
+
+- Ovarian carcinoma, Small cell lung cancer: CrCl 20-30: Initial dose 0.75 mg/m2.
+- Cervical cancer: Treatment to be initiated only if serum creatinine ≤1.5 mg/dl.
+
+
Hepatic Impairment: Avoid
","Symptoms: Bone marrow supression.
",,"Add 4 ml of sterile water for inj to the vial containing 4 mg of topotecan in order to obtain a solution with 1 mg/ml of topotecan. The required daily dose is further diluted in a suitable volume (e.g. 50-250 ml) of 5% dextrose or 0.9% sodium chloride inj and infused IV over a period of 30 min. Solution should be prepared immediately before use.
","Unopened vial: Store at 20-25°C; protect from light. Reconstituted solution: Stable for 24 hr at 20-25°C in ambient light.
",13
+1096,Topiramate,topiramate-1096,https://medex.com.bd/attachments/NIqn996EEHjnHjcr9KubpDN2xF8ofo/topiramate-prescribing-information,Adjunct anti-epileptic drugs,Trigeminal neuralgia,"Epilepsy: Topiramate is indicated as monotherapy in adults and children aged 6 years and above with newly diagnosed epilepsy who have generalised tonic-clonic seizures or partial seizures with or without secondarily generalised seizures. Topiramate is indicated as adjunctive therapy ... Read more
Epilepsy: Topiramate is indicated as monotherapy in adults and children aged 6 years and above with newly diagnosed epilepsy who have generalised tonic-clonic seizures or partial seizures with or without secondarily generalised seizures. Topiramate is indicated as adjunctive therapy for adults and children over 2 years of age who are inadequately controlled on conventional first line antiepileptic drugs for partial seizures with or without secondarily generalised seizures; seizures associated with Lennox Gastaut Syndrome and primary generalised tonic-clonic seizures.
Migraine: Topiramate is indicated in adults for the prophylaxis of migraine headache. Prophylactic treatment of migraine may be considered in situations such as: adults experiencing three or more migraine attacks per month; frequent migraine attacks that significantly interfere with the patient's daily routine. Continuing therapy should be reviewed every six months.
","Adjunct anti-epileptic drugs
","A seizure is an abnormal and unregulated electrical discharge occurring in the brain. This leads to a transient interruption in brain function, manifested by reduced alertness, abnormal sensations, and focal involuntary movements or convulsions. Several types of seizures exist, with common types including tonic-clonic seizures and partial onset seizures.
The exact mechanisms by which topiramate exerts pharmacological actions on seizures and migraines are currently not fully characterized. Several properties of this drug, however, are likely to contribute to its therapeutic effects. Topiramate has been observed to exert actions on voltage-dependent sodium channels, GABA receptors, and glutamate receptors.
Topiramate stimulates GABA-A receptor activity at brain non-benzodiazepine receptor sites and reduces glutamate activity at both AMPA and kainate receptors. Normally, GABA-A receptors are inhibitory and glutaminergic receptors are stimulatory for neuronal activity. By increasing GABA activity and inhibiting glutamate activity, topiramate blocks neuronal excitability, preventing seizures and migraines. Additionally, it blocks the voltage-dependent sodium channels, further blocking seizure activity. Topiramate has been shown to inhibit various carbonic anhydrase isozymes, but the clinical significance of this is unknown at this time.
","Epilepsy: Monotherapy:
+
+- Adults and children over 16 years: Titration should begin at 25 mg nightly for 1 week. The dosage should then be increased at 1- or 2-week intervals by increments of 25 or 59 mg/day, administered in two divided doses. The recommended initial target dose for topiramate monotherapy in adults with newly diagnosed epilepsy is 100 mg/day and the maximum recommended daily dose is 400 mg.
+- Children aged 6-16 years: Treatment of children aged 6 years and above should begin at 0.5 to 1 mg/kg nightly for the first week. The dosage should then be increased at 1- or 2-week intervals by increments of 0.5 to 1 mg/kg/day, administered in two divided doses. The recommended initial target dose range for topiramate monotherapy in children with newly diagnosed epilepsy aged 6 years and above is 3 to 6 mg/kg/day. Higher doses have been tolerated and rarely doses up to 16 mg/kg/day have been given.
+
+Epilepsy: Adjunctive therapy:
+
+- Adults and children over 16 years: The minimal effective dose as adjunctive therapy is 200 mg per day. The usual total daily dose is 200 mg to 400 mg in two divided doses. Some patients may require doses up to 800 mg per day, which is the maximum recommended dose.
+- Children aged 2-16 years: The recommended total daily dose of Topiramate as adjunctive therapy is approximately 5 to 9 mg/kg/day in two divided doses. Titration should begin at 25 mg nightly for the first week. The dosage should then be increased at 1- or 2-week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses), to achieve optimal clinical response. Dose titration should be guided by clinical outcome. Daily doses up to 30 mg/kg/day have been studied and were generally well tolerated.
+
+Migraine:
+
+- Adults and children over 16 years: Titration should begin at 25 mg nightly for 1-week. The dosage should then be increased in increments of 25 mg/day administered at 1-week intervals. The recommended total daily dose of topiramate as treatment for the prophylaxis of migraine headache is 100 mg/day administered in two divided doses. Some patients may experience a benefit at a total daily dose of 50 mg/day.
+- Children: Topiramate in migraine prophylaxis has not been studied in children under 16 years.
+
",,"The addition of topiramate to other antiepileptic drugs (phenytoin, carbamazepine, valproic add, phenobarbitai, primidone) has no clinically significant effect on their steady-state plasma concentrations, except in some patients where the addition of topiramate to phenytoin may result in an increase of plasma concentrations of phenytoin.
CNS Depressants: Topiramate should be used with caution if used in combination with alcohol and other CNS depressants.
Oral Contraceptives: In an interaction study with a combined oral contraceptive, Topiramate increased plasma clearance of the oestrogenic component significantly. Consequently, and bearing in mind the potential risk of teratogenicity, patients should receive a preparation containing not less than 50 μg of oestrogen or use some alternative non-hormonal method of contraception. Patients taking oral contraceptives should be asked to report any change in their bleeding patterns.
Lithium: In patients with bipolar disorder, the pharmacokinetics of lithium were unaffected during treatment with Topiramate at doses of 200 mg/day; however, there was an observed increase in systemic exposure (26% for AUC) following Topiramate doses of up to 600 mg/day. Lithium levels should be monitored when co-administered with Topiramate.
Hydrochlorothiazide (HCTZ): The steady-state pharmacokinetics of HCTZ were not significantly influenced by the concomitant administration of Topiramate. Clinical laboratory results indicated decreases in serum potassium after Topiramate or HCTZ administration, which were greater when HCTZ and Topiramate were administered in combination.
Metformin: Topiramate did not affect metformin tmax. The clinical significance of the effect of topiramate on metformin pharmacokinetics is unclear. Oral plasma clearance of topiramate appears to be reduced when administered with metformin. The clinical significance of the effect of metformin on topiramate pharmacokinetics is unclear. When Topiramate is added or withdrawn in patients on metformin therapy, careful attention should be given to the routine monitoring for adequate control of their diabetic disease state.
Pioglitazone: When Topiramate is added to pioglitazone therapy or pioglitazone is added to Topiramate therapy, careful attention should be given to the routine monitoring of patients for adequate control of their diabetic disease state.
Glibenclamide: The steady-state pharmacokinetics of Topiramate were unaffected by concomitant administration of glibenclamide. When Topiramate is added to glibenclamide therapy or glibenclamide is added to Topiramate therapy, careful attention should be given to the routine monitoring of patients for adequate control of their diabetic disease state.
Others: Topiramate, when used concomitantly with other agents predisposing to nephrolithiasis, may increase the risk of nephrolithiasis. While using Topiramate, agents like these should be avoided since they may create a physiological environment that increases the risk of renal stone formation. The interaction with benzodiazepines has not been studied.
Valproic Acid: Concomitant administration of Topiramate and valproic acid has been associated with hyperammonemia with or without encephalopathy in patients who have tolerated either drug alone. An association of hyperammonemia with Topiramate monotherapy or concomitant treatment with other anti epileptics has not been established.
","Hypersensitivity to any component of this product.
","Nausea, abdominal pain, dyspepsia, diarrhoea, dry mouth, taste disturbance, weight loss, anorexia, paraesthesia, hypoaesthesia, headache, fatigue, dizziness, speech disorder, drowsiness, insomnia, impaired memory & concentration, anxiety, depression, visual disturbance, lesscommonly: sucidal ideation, rarely: reduced sweetening mainly children, metabolic acidosis and alopecia, very rarely: Leucopenia, thrombocytopenia and serious skin reaction.
","Topiramate should not be used during pregnancy unless, in the opinion of the physician, the potential benefit outweighs the potential risk to the foetus. Topiramate should not be used during breastfeeding.
","In patients with or without a history of seizures or epilepsy, antiepileptic drugs, including topiramate, should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency. Topiramate can produce central nervous system-related adverse events and may be more sedative than other antiepileptic drugs. Drowsiness is a likelihood. In addition, there have been reports of visual disturbances/blurred vision. Patients should be warned of these and advised that if affected, they should not drive, operate machinery and/or take part in activities where such reactions could put themselves or others at risk.
",,"Topiramate overdose can result in severe metabolic acidosis. In acute topiramate overdose, if the ingestion is recent, the stomach should be emptied immediately by lavage or by induction of emesis. Activated charcoal has been shown to adsorb topiramate in vitro. Treatment should be appropriately supportive. Haemodialysis has been shown to be an effective means of removing topiramate from the body. The patient should be well hydrated.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+1810,Tolvaptan,tolvaptan-1810,https://medex.com.bd/attachments/OTZDzni4Ce4CBZZiKqXMJBJcasNUuv/tolvaptan-prescribing-information,Selective vasopressin V2-receptor antagonist,Kidney disease,"Tolvaptan is indicated in-
+
+- Hypervolemic or euvolemic hyponatremia.
+- Autosomal dominant polycystic kidney disease.
+
","Selective vasopressin V2-receptor antagonist
","Tolvaptan is a selective vasopressin V2-receptor antagonist. Tolvaptan affinity for the V2-receptor is 29 times greater than for the V1a-receptor. When taken orally, 15 to 60 mg doses of Tolvaptan antagonize the effect of vasopressin and cause an increase in urine water excretion that results in an increase in free water clearance (aquaresis), a decrease in urine osmolality, and a resulting increase in serum sodium concentrations. Urinary excretion of sodium and potassium and plasma potassium concentrations are not significantly changed.
","Hypervolemic or euvolemic hyponatremia: The usual starting dose for Tolvaptan is 15 mg administered once daily without regard to meals. Increase the dose to 30 mg once daily, after at least 24 hours, to a maximum of 60 mg once daily, as needed to achieve the desired level of serum sodium. Do not use for more than 30 days due to the risk of hepatotoxicity.
Autosomal dominant polycystic kidney disease (ADPKD):
+
+- Initially: 60 mg/day in divided doses (given as 45 mg upon wakening and 15 mg 8 hours later);
+- Titrate per response and tolerability at intervals of at least 7 days between titrations to 90 mg/day in divided doses (given as 60 mg upon wakening and 30 mg 8 hours later) followed by 120 mg/day in divided doses (given as 90 mg upon wakening and 30 mg 8 hours later).
+- Maintain urine osmolality of <300 mOsm/kg if possible; if the maximum dose is not tolerated, administration of a lower dose with the goal of achieving urine osmolality of 250 to 300 mOsm/kg is reasonable.
+
",,"Other Drugs Affecting Exposure to Tolvaptan:
+
+- CYP 3A Inhibitors: Tolvaptan is a substrate of CYP 3A. CYP 3A inhibitors can lead to a marked increase in Tolvaptan concentrations. Do not use Tolvaptan with strong inhibitors of CYP 3A and avoid concomitant use with moderate CYP 3A inhibitors.
+- CYP 3A Inducers: Avoid co-administration of CYP 3A inducers (e.g., Rifampin, Rifabutin, Rifapentin, Barbiturates, Phenytoin, Carbamazepine) with Tolvaptan, as this can lead to a reduction in the plasma concentration of Tolvaptan and decreased effectiveness of Tolvaptan treatment. If co-administered with CYP 3A inducers, the dose of Tolvaptan may need to be increased.
+- P-gp Inhibitors: The dose of Tolvaptan may have to be reduced when Tolvaptan is co-administered with P-gp inhibitors, e.g., Cyclosporine.
+
","Hypersensitivity to the active substance or to any of the excipients, anuria, volume depletion, hypovolemic hyponatremia, hypernatremia, Patients who cannot perceive thirst, pregnancy, breast-feeding.
","The most common side effects of Tolvaptan are: thirst, dry mouth, weakness, constipation, making large amounts of urine and urinating often & increased blood sugar levels.
","There are no or limited amount of data from the use of Tolvaptan in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Tolvaptan is contraindicated during pregnancy. Women of childbearing potential have to use effective contraception during Tolvaptan treatment. It is unknown whether Tolvaptan is excreted in human milk.
","Too rapid correction of serum sodium can cause serious neurologic sequelae.
","Pediatric Use: Safety and effectiveness of Tolvaptan in pediatric patients have not been established.
Geriatric Use: Of the total number of hyponatremic subjects treated with Tolvaptan in clinical studies, 42% were 65 and over, while 19% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Increasing age has no effect on Tolvaptan plasma concentrations.
Use in Patients with Hepatic Impairment: Moderate and severe hepatic impairment do not affect exposure to Tolvaptan to a clinically relevant extent. Avoid use of Tolvaptan in patients with underlying liver disease.
Use in Patients with Renal Impairment: No dose adjustment is necessary based on renal function. There are no clinical trial data in patients with CrCl<10 ml/min, and, because drug effects on serum sodium levels are likely lost at very low levels of renal function, use in patients with a CrCl<10 ml/min is not recommended. No benefit can be expected in patients who are anuric.
Use in Patients with Congestive Heart Failure: The exposure to Tolvaptan in patients with congestive heart failure is not clinically relevantly increased. No dose adjustment is necessary.
","Single doses up to 480 mg and multiple doses up to 300 mg per day for 5 days have been well tolerated in clinical trials in healthy volunteers. There is no specific antidote for Tolvaptan intoxication. The signs and symptoms of an acute overdose can be anticipated to be those of excessive pharmacologic effect: a rise in serum sodium concentration, polyuria, thirst and dehydration/ hypovolemia (profuse and prolonged aquaresis). In patients with suspected Tolvaptan overdose, assessment of vital signs, electrolyte concentrations, ECG and fluid status is recommended. Appropriate replacement of water and/or electrolytes must continue until aquaresis abates. Dialysis may not be effective in removing Tolvaptan because of its high binding affinity for human plasma protein (>98%).
",,,"Store at below 25°C in a dry place, protected from light. Keep out of reach of children.
",12
+1095,Tolterodine Tartrate,tolterodine-tartrate-1095,https://medex.com.bd/attachments/OufZAXvhGanyv3Qc69M3Yi9GO9hRWt/tolterodine-tartrate-tablet-prescribing-information,BPH/ Urinary retention/ Urinary incontinence,Urinary incontinence,"Tolterodine Tartrate is indicated for the treatment of overactive bladder with symptoms of urinary urgency, frequency, and/or urge incontinence.
","BPH/ Urinary retention/ Urinary incontinence
","Tolterodine is a competitive, specific muscarinic receptor antagonist which exhibits a selectivity for the urinary bladder over salivary glands, which have been demonstrated in non clinical pharmacological in vivo studies. Tolterodine has a high specificity for muscarinic receptors. A major active metabolite (5-hydroxymethyl derivative) of tolterodine exhibits a pharmacological profile which is similar to that of the parent compound. In extensive metabolisers this metabolite contributes significantly to the therapeutic effect of tolterodine. The effect of treatment can be expected within 4 weeks.
","The recommended dose for tolterodine is 2 mg twice daily. In case of troublesome side effects the dose may be reduced from 2 mg to 1 mg twice daily.
The recommended total daily dose of tolterodine is 2 mg (1 mg b.i.d.) for patients with impaired renal function, impaired liver function, or receiving concomitant medication with potent CYP3A inhibitors, such as macrolide antibiotics (e.g. erythromycin and clarithromycin) or azole antifungal agents (e.g. ketoconazole, itraconazole and miconazole). After six months the need for further treatment should be considered.
",,"Pharmacokinetic interactions are possible with other drugs metabolised by or inhibiting cytochrome P450 2D6 (CYP2D6) or CYP3A4. Concomitant treatment with fluoxetine does not result in a clinically significant interaction.
Ketoconazole, a potent inhibitor of CYP3A, significantly increased plasma concentrations of tolterodine when coadministered to poor metabolisers (i.e. persons devoid of CYP2D6 metabolic pathway).
Clinical studies have shown no interactions with warfarin or combined oral contraceptives (ethinyloestradiol or levonorgestrel).
","Tolterodine is contraindicated in those patients with urinary retention, uncontrolled narrow angle glaucoma, known hypersensitivity to tolterodine or any other component of the drug.
","Tolterodine may cause mild to moderate antimuscarinic effects, like dryness of mouth, dyspepsia and/or reduced lacrimation.
","There are no studies in pregnant women. Therefore, tolterodine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use of tolterodine during lactation should be avoided since no data on excretion of the drug into breast milk in humans is available.
","Tolterodine should be used with caution in the following patients:
+
+- at risk for urinary retention
+- at risk for decreased gastrointestinal motility
+- with impaired renal function
+- with impaired hepatic function
+
+Organic reasons for urge and frequency should be considered before treatment.
","Pediatric use: Safety and effectiveness of tolterodine in children have not been established.
Geriatric use: No overall differences in safety were observed between the older and younger patients treated with Tolterodine.
","Overdosage with Tolterodine Tartrate capsules can potentially result in severe central anticholinergic effects and should be treated accordingly. ECG monitoring is recommended in the event of overdosage.
",,,"Store in a cool and dry place. Protect from light. Keep out of the reach of children.
",12
+1094,Tolperisone Hydrochloride,tolperisone-hydrochloride-1094,https://medex.com.bd/attachments/AJOVurk0W5ARCeo4ap9rkzjhclkcmV/tolperisone-hydrochloride-prescribing-information,Central Depolarizing muscle relaxants,Spasticity and muscle spasms,"Tolperisone Hydrochloride is indicated in-
+
+- Treatment of increased tone of skeletal muscles due to organic neurological disorders (injury of the pyramidal tract, multiple sclerosis, myelopathy, encephalomyelitis).
+- Treatment of muscular spasm, muscular contracture, rigidity, spinal automatism.
... Read more
Tolperisone Hydrochloride is indicated in-
+
+- Treatment of increased tone of skeletal muscles due to organic neurological disorders (injury of the pyramidal tract, multiple sclerosis, myelopathy, encephalomyelitis).
+- Treatment of muscular spasm, muscular contracture, rigidity, spinal automatism.
+- In the treatment of vascular diseases (Obliterative arteriosclerosis, diabetic angiopathy, obliterative thromboangitis, Raynaud's disease, diffuse scleroderma).
+- In individual cases, post-thrombotic venous and lymphatic circulation disorders and crural ulcer.
+
","Central Depolarizing muscle relaxants, Centrally acting Skeletal Muscle Relaxants
","Tolperisone Hydrochloride is a centrally acting muscle relaxant, which acts on the central nervous system and used mainly for the treatment of elevated muscle tone and tension as well as for certain circulation problems in the extremities.
","The recommended dose is as follows:
+
+- Adult: 50-150 mg three times daily according to the individual requirement and tolerance of the patient.
+- Children (from 3 months to 6 years): 5 mg/kg/day in three divided doses.
+- Children (from 6 to 14 years): 2-4 mg/kg/day in three divided doses. or, as directed by the registered physician.
+
",,"Concomitant use of methocarbamol with Tolperisone Hydrochloride has been reported to cause disturbance of visual accommodation.
","It is contraindicated in patients with a history of hypersensitivity to any component of the product, myasthenia gravis and nursing mother.
","Possible side-effects include sometimes muscular weakness, headache, nausea, vomiting and rarely hypersensitivity reactions (itching, redness of the skin, skin rash) may occur.
","Tolperisone Hydrochloride should be used in pregnancy according to the physician's advice. It should not be used during breast feeding.
","In case of children, the prescribed dose and duration of treatment should closely be observed.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+1211,Tolperisone + Lidocaine,tolperisone-lidocaine-1211,,Centrally acting Skeletal Muscle Relaxants,Spinal automatism and discopathy,"Increased tone of skeletal muscles due to organic neurological disorders (e.g. injury of the pyramidal tract, multiple sclerosis, myelopathy, encephalomyelitis etc.), muscular hypertension, muscular spasm, muscular contracture, rigidity, spinal automatism and discopathy, obliterative vascular diseases ... Read more
Increased tone of skeletal muscles due to organic neurological disorders (e.g. injury of the pyramidal tract, multiple sclerosis, myelopathy, encephalomyelitis etc.), muscular hypertension, muscular spasm, muscular contracture, rigidity, spinal automatism and discopathy, obliterative vascular diseases (obliterative arteriosclerosis, diabetic angiopathy, obliterative thromboangitis, Raynaud's disease, diffuse scleroderma) and disorders due to injured innervation of the vessels (acrocyanosis, intermittent angioneurotic dysbasia). In individual cases, post-thrombotic venous and lymphatic circulation disorders, crural ulcer.
","Centrally acting Skeletal Muscle Relaxants, Locally acting Skeletal Muscle Relaxants
","Tolperisone Hydrochloride is a centrally acting muscle relaxant. It effectively reduces muscular hypertonicity, improves peripheral blood flow by vasodilatation and reduces pain. Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action.
","The usual dose is one ampoule twice daily by intramuscularly. Injection should be given slowly. Accordingly to age and symptom, the dosage may be changed.
",,,"Hypersensitivity to any component of the product, Myasthenia gravis, Nursing mother
","Sometimes, muscular weakness, headache, nausea, vomiting and rarely hypersensitivity reactions may occur as side effects.
","Tolperisone hydrochloride should be used in pregnancy according to physician's advice. Tolperisone hydrochloride should not be used during breast feeding.
","In case of children, the prescribed dose and duration of treatment should closely be observed.
",,"In the event of over dosage, supportive therapy may be substituted.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+1093,Tolnaftate,tolnaftate-1093,https://medex.com.bd/attachments/pLQD1ml2OEW1rW0EwCJma7viWpTJtV/tolnaftate-prescribing-information,Other Antifungal preparations,Superficial dermatophyte infections and pityriasis versicolor,"Tolnaftate is used to treat skin infections such as athlete's foot, jock itch, and ringworm. It is an antifungal that works by preventing the growth of fungus.
","Other Antifungal preparations
","Tolnaftate is an antifungal which inhibits growth of dermatophytes e.g. Epidermophyton, Microsporum, trichophyton spp, and Malassezia furfur by distorting the hyphae and stopping mycelial growth. It is inactive against Candida spp or bacteria.
","Use this medication on the skin only. Clean and thoroughly dry the area to be treated. Apply this medication to the affected skin, usually twice a day or as directed on the product package or by your doctor. Dosage and length of treatment depends on the type of infection being treated.
Some forms of tolnaftate (e.g., powder) need to be shaken before applying. Check your product package to see if your form of this medication needs to be shaken. Apply enough medication to cover the affected area and some of the surrounding skin. After applying this medication, wash your hands. Do not wrap, cover, or bandage the area unless directed to do so by your doctor.
Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time(s) each day.
Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after starting tolnaftate. Stopping the medication too early may allow the fungus to continue to grow, which may result in a relapse of the infection.
Inform your doctor if your condition persists after 2 weeks of treatment for jock itch, after 4 weeks of treatment for athlete's foot or ringworm, or if your condition worsens at any time.
",,,"Hypersensitivity. Nail and scalp infections. Do not apply this medication in the eyes, nose, mouth, or vagina.
","Irritation of the treated skin may occur. If this effect persists or worsens, notify your doctor or pharmacist promptly.
If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
","Tolnaftate topical has not been formally assigned to a pregnancy category by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Tolnaftate topical is only recommended for use during pregnancy when benefit outweighs risk. There are no data on the excretion of tolnaftate topical into human milk.
","Before using tolnaftate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system problems (e.g., organ transplant, HIV disease), diabetes.
This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
",,,,,"Store at 15-30° C.
",9
+1092,Tolfenamic acid,tolfenamic-acid-1092,,Other drugs for migraine,Pain,"Tolfenamic acid is used specifically for relieving the pain of migraine headache and also recommended for use as an analgesic in post-operative pain and fever.
","Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs), Other drugs for migraine
","Tolfenamic acid (N-(2-methyl-3-chlorophenyl) anthranilic acid) belongs to the fenamate group and is a potent inhibitor of cyclooxygenase enzyme, thus it inhibits the synthesis of important inflammatory mediators such as thromboxane (TX) B2 and prostaglandin (PG) E2. Prostaglandins are responsible for causing swelling pain and inflammation associated with these conditions. It acts not only by inhibiting prostaglandin synthesis, but it also has direct antagonistic action on its receptors.
Pharmacokinetic properties: Absorption Readily absorbed from GI tract. Peak plasma concentration: 60-90 min. Bioavailability 85%. Distribution: Protein-binding: 99% Plasma half-life 2 hours. Metabolism: Metabolised in the liver. Tolfenamic acid undergoes enterohepatic circulation. Excretion: Excreted in urine (90%) and faces.
","Adult:
+
+- Acute migraine attacks: 200 mg when symptoms appear may be repeated once after 1-2 hour.
+- Mild to moderate pain: 100-200 mg tid
+- Renal impairment: Dose adjustments may be needed.
+- Severe renal impairment: Avoid.
+
+Children: A pediatric dosage regimen has not yet been established.
Tolfenamic acid should be taken with food. Take water during or immediately after meals.
",,"The rate of absorption of Tolfenamic acid increases with Metoclopramide and Magnesium hydroxide but decreases with Aluminium hydroxide. Risk of bleeding with anticoagulants and other NSAIDS increases when use with Tolfenamic acid. It decreases antihypertensive response to loop diuretics, B-blockers and ACE Inhibitors. Co-administration increases plasma concentration of Lithium Methotrexate and cardiac glycosides. It also increases the risk of nephrotoxicity with ACE inhibitors, Ciclosporin, Tacrolimus or diuretics
","Active peptic ulcer or bleeding in the gut. Severe heart, kidney or liver failure.
","Dysuria especially in males, diarrhoea, nausea epigastric pain, vomiting, dyspepsia, erythema, headache, tremor, euphoria, fatigue, pulmonary infiltration & haematuria. Potentially fatal: Blood dyscrasias and hepatitis.
","This medicine is not recommended for using during pregnancy unless considered essential by doctor Not to be given during the third trimester of pregnancy. NSAID's can appear in breast milk in very low concentrations NSAID's should, if possible, be avoided when breastfeeding.
","Precaution should be needed for patients with asthma bronchospasm, bleeding disorders, cardiovascular diseases, peptic ulceration, hypertension, liver infection, cardiac or renal function impairment and elderly. Increase water intake or dose reduction to reduce dysuria.
",,"Symptoms include headache, nausea, vomiting, epigastric pain. gastrointestinal bleeding, diarrhoea excitation, coma, drowsiness dizziness, tinnitus, fainting and convulsions. In cases of significant poisoning, acute renal failure and liver damage are possible. Patients should be treated symptomatically as required.
",,,"Store in a cool and dry place, away from light Keep out of the reach of children.
",11
+1392,Tofacitinib,tofacitinib-1392,https://medex.com.bd/attachments/65c922U5wm7pQS38Je2uHIzkaK2Y7M/tofacitinib-prescribing-information,Immunosuppressant,Ulcerative colitis,"Rheumatoid Arthritis: Tofacitinib is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic ... Read more
Rheumatoid Arthritis: Tofacitinib is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).
Psoriatic Arthritis: Tofacitinib is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).
Ulcerative Colitis: Tofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).
","Immunosuppressant
","Rheumatoid arthritis is an autoimmune disease characterized by a dysregulation of pro-inflammatory cytokines including IL7, IL15, IL21, IL6, IFN-alpha, and IFN-beta. (3) Cytokines signalling results in tissue inflammation and joint damage by stimulating the recruitment and activation of immune cells via the janus kinase signalling pathway.
Tofacitinib is a partial and reversible janus kinase (JAK) inihibitor that will prevent the body from responding to cytokine signals. By inhibiting JAKs, tofacitinib prevents the phosphorylation and activation of STATs. The JAK-STAT signalling pathway is involved in the transcription of cells involved in hematopoiesis, and immune cell function. Tofacitinib works therapeutically by inhibiting the JAK-STAT pathway to decrease the inflammatory response. However, there is evidence to suggest that it may also achieve efficacy via other pathways as well.
","Rheumatoid Arthritis: Tofacitinib 5 mg twice daily or Tofacitinib 11 mg once daily. Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment is Tofacitinib 5 mg once daily.
Psoriatic Arthritis (in combination with nonbiologic DMARDs): Tofacitinib 5 mg twice daily or Tofacitinib 11 mg once daily. Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment is Tofacitinib 5 mg once daily.
Ulcerative Colitis: Tofacitinib 10 mg twice daily for at least 8 weeks; then 5 or 10 mg twice daily. Discontinue after 16 weeks of 10 mg twice daily, if adequate therapeutic benefit is not achieved. Use the lowest effective dose to maintain response.
",,"
+- Potent inhibitors of Cytochrome P450 3A4 (CYP3A4) (e.g., Ketoconazole)
+- Recommended dose is Tofacitinib 5 mg once daily: One or more concomitant medications that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole)
+- Recommended dose is Tofacitinib 5 mg once daily Potent CYP inducers (e.g.Rifampin): May result in loss of or reduced clinical response.
+
",,"The most commonly reported adverse reactions during the first 3 months in controlled clinical trials (occurring in greater than or equal to 2% of patients treated with Tofacitinib monotherapy or in combination with DMARDs) were upper respiratory tract infections, headache, diarrhea and nasopharyngitis.
","Pregnancy Category C. There are no adequate and well controlled studies in pregnant women. Tofacitinib should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether Tofacitinib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Tofacitinib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug for the mother
","
+- Serious Infections: Avoid use of Tofacitinib during an active serious infection, including localized infections.
+- Gastrointestinal Perforations: Use with caution in patients that may be at increased risk.
+- Laboratory Monitoring: Recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes and lipids.
+- Immunizations: Live vaccines: Avoid use with Tofacitinib.
+- Do not initiate Tofacitinib if absolute lymphocyte count <500 cells/mm3, an absolute neutrophil count (ANC) <1000 cells/mm3 or hemoglobin <9 gm/dL.
+
","Pediatric Use: The safety and effectiveness of Tofacitinib in pediatric patients have not been established.
Geriatric Use: The frequency of serious infection among Tofacitinib-treated subjects 65 years of age and older was higher than among those under the age of 65. As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly.
Moderate and severe renal impairment or moderate hepatic impairment: half the total daily dosage recommended for patients with normal renal and hepatic function.
",,,,"Store below 30°C. Protect from light & moisture. Keep all medicines out of the reach of children.
",10
+1091,Tocilizumab,tocilizumab-1091,https://medex.com.bd/attachments/4LgWrPCytFf9Pd3jL2rg3px1P0wnAg/tocilizumab-prescribing-information,Drugs used for Rheumatoid Arthritis,Rheumatoid arthritis,"Tocilizumab is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of:
+
+- Rheumatoid Arthritis (RA): Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
... Read more
Tocilizumab is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of:
+
+- Rheumatoid Arthritis (RA): Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
+- Giant Cell Arteritis (GCA): Adult patients with giant cell arteritis.
+- Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD): Slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD)
+- Polyarticular Juvenile Idiopathic Arthritis (PJIA): Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.
+- Systemic Juvenile Idiopathic Arthritis (SJIA): Patients 2 years of age and older with active systemic juvenile idiopathic arthritis.
+- Cytokine Release Syndrome (CRS): Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome.
+
","Drugs used for Rheumatoid Arthritis
","Tocilizumab binds to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and has been shown to inhibit IL-6-mediated signaling through these receptors. IL-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T- and B-cells, lymphocytes, monocytes and fibroblasts. IL-6 has been shown to be involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation. IL-6 is also produced by synovial and endothelial cells leading to local production of IL-6 in joints affected by inflammatory processes such as rheumatoid arthritis.
","Rheumatoid Arthritis: Recommended Adult Intravenous Dosage: When used in combination with DMARDs or as monotherapy the recommended starting dose is 4 mg per kg every 4 weeks followed by an increase to 8 mg per kg every 4 weeks based on clinical response.
+
+- Patients less than 100 kg weight: 162 mg administered subcutaneously every other week, followed by an increase to every week based on clinical response
+- Patients at or above 100 kg weight: 162 mg administered subcutaneously every week.
+
+
Giant Cell Arteritis: Recommended Adult Subcutaneous Dosage: The recommended dose of tocilizumab for adult patients with GCA is 162 mg given once every week as a subcutaneous injection, in combination with a tapering course of glucocorticoids. A dose of 162 mg given once every other week as a subcutaneous injection, in combination with a tapering course of glucocorticoids, may be prescribed based on clinical considerations. tocilizumab can be used alone following discontinuation of glucocorticoids. tocilizumab subcutaneous formulation is not intended for intravenous administration.
Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD): Recommended Adult Subcutaneous Dosage: The recommended dose of tocilizumab for adult patients with SSc-ILD is 162 mg given once every week as a subcutaneous injection.
Polyarticular Juvenile Idiopathic ArthritisRecommended Intravenous PJIA Dosage Every 4 Weeks-
+
+- Patients less than 30 kg weight: 10 mg per kg
+- Patients at or above 30 kg weight: 8 mg per kg
+
+Recommended Subcutaneous PJIA Dosage-
+
+- Patients less than 30 kg weight: 162 mg once every three weeks
+- Patients at or above 30 kg weight: 162 mg once every two weeks
+
+
Systemic Juvenile Idiopathic ArthritisRecommended Intravenous SJIA Dosage Every 2 Weeks-
+
+- Patients less than 30 kg weight: 12 mg per kg
+- Patients at or above 30 kg weight: 8 mg per kg
+
+Recommended Subcutaneous SJIA Dosage-
+
+- Patients less than 30 kg weight 162 mg every two weeks
+- Patients at or above 30 kg weight 162 mg every week
+
+
Cytokine Release SyndromeRecommended Intravenous CRS Dosage-
+
+- Patients less than 30 kg weight: 12 mg per kg
+- Patients at or above 30 kg weight: 8 mg per kg
+
+Alone or in combination with corticosteroids.
General Dosing Information:
+
+- It is recommended that tocilizumab not be initiated in patients with an absolute neutrophil count (ANC) below 2000 per mm3, platelet count below 100,000 per mm3, or who have ALT or AST above 1.5 times the upper limit of normal (ULN).
+- tocilizumab doses exceeding 800 mg per infusion are not recommended in RA or CRS patients.
+
",,"Interactions with CYP450 Substrates: Cytochrome P450s in the liver are down-regulated by infection and inflammation stimuli including cytokines such as IL-6. Inhibition of IL-6 signaling in RA patients treated with tocilizumab may restore CYP450 activities to higher levels than those in the absence of tocilizumab leading to increased metabolism of drugs that are CYP450 substrates. In vitro studies showed that tocilizumab has the potential to affect expression of multiple CYP enzymes including CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6 and CYP3A4. Its effect on CYP2C8 or transporters is unknown. In vivo studies with omeprazole, metabolized by CYP2C19 and CYP3A4, and simvastatin, metabolized by CYP3A4, showed up to a 28% and 57% decrease in exposure one week following a single dose of tocilizumab, respectively. The effect of tocilizumab on CYP enzymes may be clinically relevant for CYP450 substrates with narrow therapeutic index, where the dose is individually adjusted. Upon initiation or discontinuation of tocilizumab, in patients being treated with these types of medicinal products, perform therapeutic monitoring of effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) and the individual dose of the medicinal product adjusted as needed. Exercise caution when coadministering tocilizumab with CYP3A4 substrate drugs where decrease in effectiveness is undesirable, e.g., oral contraceptives, lovastatin, atorvastatin, etc. The effect of tocilizumab on CYP450 enzyme activity may persist for several weeks after stopping therapy
","Hypersensitivity to tocilizumab or to any of the excipients.
","Most common adverse reactions (incidence of at least 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, injection site reactions.
","Based on animal data, may cause fetal harm. Discontinue drug or nursing taking into consideration importance of drug to mother.
","
+- Serious Infections- do not administer tocilizumab during an active infection, including localized infections. If a serious infection develops, interrupt tocilizumab until the infection is controlled.
+- Gastrointestinal (GI) perforation- use with caution in patients who may be at increased risk.
+- Hepatotoxicity- Monitor patients for signs and symptoms of hepatic injury. Modify or discontinue tocilizumab if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.
+- Laboratory monitoring- recommended due to potential consequences of treatment-related changes in neutrophils, platelets, lipids, and liver function tests.
+- Hypersensitivity reactions, including anaphylaxis and death have occurred.
+- Live vaccines- Avoid use with tocilizumab.
+
",,"There are limited data available on overdoses with tocilizumab. One case of accidental overdose was reported with intravenous tocilizumab in which a patient with multiple myeloma received a dose of 40 mg per kg. No adverse drug reactions were observed. No serious adverse drug reactions were observed in healthy volunteers who received single doses of up to 28 mg per kg, although all 5 patients at the highest dose of 28 mg per kg developed dose-limiting neutropenia. In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions. Patients who develop adverse reactions should receive appropriate symptomatic treatment.
",,,"Tocilizumab must be refrigerated at 2ºC to 8ºC. Do not freeze. Protect the vials, syringes, and autoinjectors from light by storage in the original package until time of use, and keep syringes and autoinjectors dry.
",11
+1089,Tobramycin (Ophthalmic),tobramycin-ophthalmic-1089,https://medex.com.bd/attachments/LFrr4bmUDU1iF61HDXWwISlz8sitoz/tobramycin-ophthalmic-prescribing-information,Ophthalmic antibacterial drugs,Ocular infections,"Tobramycin is a topical antibiotic indicated in the treatment of external bacterial infections of the eye caused by susceptible organisms. Such as,
Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus spp. of ... Read more
Tobramycin is a topical antibiotic indicated in the treatment of external bacterial infections of the eye caused by susceptible organisms. Such as,
Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus spp. of group A beta-hemolytic and some nonhemolytic species.
Gram-negative bacteria: E.coli, Pseudomonas aeruginosa, Enterobacter aerogenes, Klebsiella spp., Proteusmirabillis, Proteus vulgaris, Haemophilus influenzae, Morganella morganii, Acinetobacter calcoaceticus, Providentia, Serratia, Salmonella spp and some strains of Neisseria.
","Ophthalmic antibacterial drugs
","Like other aminoglycosides, the bactericidal activity of Tobramycin is taken up into sensitive bacterial cells by an active transport process. Within the cell Tobramycin bind to the 30s, and to some extent to the 50s subunits of the bacterial ribosome, inhibiting protein synthesis and generating errors in the transcription of the genetic code. The manner in which cell death is brought about is imperfectly understood, and other mechanisms may contribute, including effects on membrane permeability.
","Ophthalmic ointment:
+
+- In mild to moderate infection, apply a small amount 2-3 times daily into the conjunctival sac(s).
+- In severe cases of infection, apply a small amount 3-4 times daily into the conjunctival sac(s) until improvement is obtained, then reduce the dose gradually.
+
+
Ophthalmic solution:
+
+- In mild to moderate infections: Instill 1or 2 drops into the affected eye(s) every 4 hours.
+- In severe infections: Instill 2 drops into the affected eye(s) every hour until improvement is observed.
+
+
Pediatric use: Safety and effectiveness in children below the age of 1 year have not been established.
",,"Care should be exercised when tobramycin is given to patients receiving other drugs with neuromauscular blocking agents or ototoxic.
","It is contraindicated in patients who are hypersensitive to Tobramycin or any of the ingredients of the preparation.
","The most frequent side effect of Tobramycin ophthalmic solution is localized ocular toxicity, conjunctival erythema, hypersensitivity including lid itching and swelling.
","Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. This drug should only be used during pregnancy, if the potential benefits outweigh the possible risk to the fetus. Drug may excreted into human milk. A decision should be made whether to discontinue nursing or to taking the drug.
","Minor sensitivity may occur to topically applied aminoglycosides in some patients. If a sensitivity reaction occurs, discontinue use. Prolonged use may result in overgrowth of nonsusceptible organisms and fungi.
",,"Sign and symptoms of overdose may be similar to side effects as described above.
",,,"Protect from light, store in cool (below 25°C) & dry place. Keep out of reach of children. Used within 4 weeks after first opening.
",11
+1090,Tobramycin (Nebuliser Solution),tobramycin-nebuliser-solution-1090,https://medex.com.bd/attachments/gBvrEdwnv9vUH8b27dDCAntZQ05JOU/tobramycin-nebuliser-solution-prescribing-information,Aminoglycosides,Cystic fibrosis,"Tobramycin Respirator Solution is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Also indicated for severe COPD patients colonized with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients below the age of 6 years, patients with a ... Read more
Tobramycin Respirator Solution is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Also indicated for severe COPD patients colonized with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients below the age of 6 years, patients with a forced expiratory volume <25% or >75% predicted, or patients colonized with Burkholderia cepacia.
","Aminoglycosides
","Tobramycin interferes with bacterial protein synthesis by binding to 30S and 50S ribosomal subunits, resulting in a defective bacterial cell membrane.
","The recommended dosage for, both adult and paediatric patients, 6 years of age and older, is one single-use ampoule (300 mg) administered b.i.d for 28 days. Dosage is not adjusted by weight.
The doses should be taken as close to 12 hours apart as possible; they should not be taken less than 6 hours apart.
If you are taking several medications, the recommended order is as follows: bronchodilator first, followed by chest physiotherapy, then other inhaled medications and finally Tobramycin.
You should take Tobramycin in repeated cycles of 28 days on drug, followed by 28 days off drug. You should take Tobramycin twice a day during the 28 day period on drug.
",,"Patients taking Tobramycin concomitantly with beta agonists, inhaled corticosteroids, other anti pseudomonal antibiotics or parenteral aminoglycosides demonstrated adverse experience profiles.
","Tobramycin is contraindicated in patients with a known hypersensitivity to any aminoglycoside.
","Inhaled Tobramycin is generally well-tolerated. Voice alterations and tinnitus are more common in the on-drug periods. However all the episodes are transient and resolved without discontinuation of the regimen. Others like dizziness and increase in serum creatinine were similar to those occurring with placebo.
","If you are a nursing mother, pregnant or want to become pregnant, ask your doctor about the possibility of Tobramycin causing any harm.
","It should be used with care in patients with known or suspected renal, auditory, vestibular, or neuromuscular dysfunction. Patients receiving concomitant aminoglycoside therapy should be monitored as clinically appropriate. It must be used with caution in patients with ototoxicity and nephrotoxicity. Discuss the use of Tobramycin with your doctor if you have kidney problems or changes in hearing. Respirator Solution must only be used by inhalation from a nebulizer and must not be injected or swallowed.
","Renal Impairment: Inhalation: Dosage adjustment needed.
","Symptoms: Nephrotoxicity, auditory and vestibular toxicity (e.g. dizziness, tinnitus, vertigo, loss of high-tone hearing acuity), neuromuscular blockade or resp failure.
Management: Initiate resuscitative measures if resp paralysis occurs. Ca salts may be given to reverse neuromuscular blockade. Haemodialysis or peritoneal dialysis will help remove drug serum levels.
",,,"Store under refrigeration at 2-8° C, and protected from light. Slight color change when unrefrigerated do not indicate any change in the quality of the product. The preparation must not be used if it is cloudy, particles appear in the solution or has been stored at room temperature for over 28 dyas. For use only under the prescription of a registered physician. Do not use Tobasol® beyond the expiration date stamped on the ampoule.
",12
+1088,Tizanidine Hydrochloride,tizanidine-hydrochloride-1088,https://medex.com.bd/attachments/75cZOAzDzqCbSU3xZdp6vsx7hO82MA/tizanidine-hydrochloride-prescribing-information,Centrally acting Skeletal Muscle Relaxants,Spasticity,"Treatment of painful muscle spasms:
+
+- Associated with static and functional disorders of the spine (cervical and lumbar syndromes).
+- Following surgery, e.g. for herniated intervertebral disc or osteoarthritis of the hip.
+
+Treatment of spasticity due to neurological
... Read moreTreatment of painful muscle spasms:
+
+- Associated with static and functional disorders of the spine (cervical and lumbar syndromes).
+- Following surgery, e.g. for herniated intervertebral disc or osteoarthritis of the hip.
+
+Treatment of spasticity due to neurological disorders:
+
+- Multiple sclerosis, chronic myelopathy, degenerative spinal cord diseases, cerebrovascular accidents, and cerebral palsy.
+
","Centrally acting Skeletal Muscle Relaxants
","Tizanidine is a centrally acting skeletal muscle relaxant. Its principal site of action is the spinal cord, where the evidence suggests that, by stimulating presynaptic alpha2 receptors, it inhibits the release of excitatory amino acids that stimulate N-methyl-D aspartate (NMDA) receptors.
Polysynaptic signal transmission at spinal interneuron level, which is responsible for excessive muscle tone, is thus inhibited and muscle tone reduced. In addition to its muscle-relaxant properties, tizanidine also exerts a moderate central analgesic effect.
Pharmacodynamic: Tizanidine is effective in both acute painful muscle spasms and chronic spasticity of spinal and cerebral origin. It reduces resistance to passive movements, alleviates spasms and clonus, and may improve voluntary strength. The antispastic activity (measured by the Ashworth score and pendulum test) and adverse effects (heart rate and blood pressure) of Tizanidine are related to plasma tizanidine concentrations.
","Tizanidine has a narrow therapeutic index and high inter-patient variability in tizanidine plasma concentrations which requires individualized dose adjustment. A low starting dose of 2 mg three times daily can minimize the risk for adverse effects. The dose should be carefully adjusted upward according to the needs of the individual patient.
Relief of painful muscle spasms: The usual dose is 2 to 4 mg three times daily in tablet form. In severe cases, an extra dose of 2 or 4 mg may be taken, preferably at night to minimize sedation.
Spasticity due to neurological disorders: The initial daily dose should not exceed 6 mg given in 3 divided doses. It may be increased stepwise at half-weekly or weekly intervals by 2 to 4 mg. The optimum therapeutic response is generally achieved with a daily dose of between 12 and 24 mg, administered in 3 or 4 equally spaced doses. The daily dose of 36 mg should not be exceeded.
Pediatrics patients: Experience in patients below 18 years of age is limited and the use of Tizanidine in this population is not recommended.
Geriatric patients (65 years of age or older): Experience with the use of Tizanidine in the elderly is limited. Therefore, it is recommended to start treatment at the lowest dose and increases should be done in small steps according to tolerability and efficacy.
Renal impairment: In patients with renal impairment (creatinine clearance <25 mL/min), it is recommended to start treatment at 2 mg once daily. An increase in dosage should be done in small steps according to tolerability and efficacy. If efficacy has to be improved, it is advisable to first increase the strength of the daily dose before increasing the frequency of administration.
Hepatic impairment: Use of Tizanidine in patients with severe hepatic impairment is contraindicated. While Tizanidine is extensively metabolized in the liver, limited data are available in this population. Its use has been associated with a reversible abnormality in liver function tests. Tizanidine should be used with caution in patients with moderate hepatic impairment and treatment should be started with the lowest dose. Afterward, an increase in dosage should be done carefully and according to patient tolerability.
Discontinuation of treatment: If Tizanidine has to be discontinued, the dosage should be slowly down titrated, particularly in patients who have received high doses for a longer period of time to avoid or minimize the risk of rebound hypertension and tachycardia.
",,"Concomitant administration of drugs known to inhibit the activity of CYP1A2 may increase the plasma levels of tizanidine. The increased plasma levels of tizanidine may result in overdose symptoms such as QT(c) prolongation. Concomitant administration of drugs known to induce the activity of CYP1A2 may decrease the plasma levels of tizanidine. The decreased plasma levels of tizanidine may reduce the therapeutic effect of Tizanidine.
Observed interactions resulting in a contraindication: Concomitant use of Tizanidine with fluvoxamine or ciprofloxacin, both CYP1A2 inhibitors is contraindicated. Concomitant use of Tizanidine with fluvoxamine or ciprofloxacin resulted in a 33-fold and 10-fold increase in tizanldine AUC, respectively. Clinically significant and prolonged hypotension may result along with somnolence, dizziness and decreased psychomotor performance. The increased plasma levels of tizanidine may result in overdose symptoms such as QT(c) prolongation.
Observed interactions resulting in concomitant use not recommended: Co administration of Tizanidine with other inhibitors of CYP1A2 such as antiarrhythmics (amiodarone, mexiletine, propafenone), cimetidine, fluoroquinolones (enoxacin, pefloxacin, norfloxacin), rofecoxib, oral contraceptives, and ticlopidine is not recommended.
Observed interactions to be considered: Caution should be exercised when Tizanidine is given with drugs known to prolong the QT interval (including but not limited to cisapride, amytriptyline and azithromycin).
Antihypertensives: Concomitant use of Tizanidine with antihypertensives, including diuretics, may occasionally cause hypotension and bradycardia. In some patients rebound hypertension and tachycardia have been observed upon abrupt discontinuation of Tizanidine when concomitantly used with antihypertensive drugs. In extreme cases, rebound hypertension might lead to cerebrovascular accident.
Rifampicin: Concomitant administration of Tizanidine with rifampicin results in 50% decrease in tizanidine concentrations. Therefore, the therapeutic effects of Tizanidine may be reduced during treatment with rifampicin, which may be of clinical significance in some patients. Long term coadministration should be avoided and if co- administration is considered a careful dose adjustment (increase) may be required.
Cigarette smoke: Administration of Tizanidine in smokers (>10 cigarettes per day) results in about 30% decrease in tizanidine systemic exposure. Long-term therapy with Tizanidine in heavy smokers may require higher doses than the average doses.
Alcohol: While on Tizanidine therapy, alcohol consumption should be minimized or avoided as it may increase the potential for adverse events (e.g. sedation and hypotension). The central nervous system depressant effects of alcohol may be enhanced by Tizanidine.
Anticipated interactions to be considered: Sedatives, hypnotics (e.g. benzodiazepine or baclofen), and another drug such as antihistamines may enhance the sedative action of tizanidine. Tizanidine should be avoided when using with other alpha-2 adrenergic agonists (such as clonidine) because of their potential additive hypotensive effect.
","
+- Known hypersensitivity to tizanidine or to any of the excipients.
+- Severely impaired hepatic function.
+- Concomitant use of tizanidine with strong inhibitors of CYP1A2 such as fluvoxamine or ciprofloxacin is contraindicated.
+
","With low doses, such as those recommended for the relief of painful muscle spasms, somnolence, fatigue, dizziness, dry mouth, blood pressure decrease, nausea, gastrointestinal disorder and transaminase increase have been reported, usually as mild and transient adverse reactions.
With the higher doses recommended for the treatment of spasticity, the adverse reactions reported with low doses are more frequent and more pronounced, but seldom severe enough to require discontinuation of treatment. In addition, the following adverse reactions may occur: hypotension, bradycardia, muscular weakness, insomnia, sleep disorder, hallucination & hepatitis.
+
+- Psychiatric disorders: Common- Insomnia, sleep disorder.
+- Nervous system disorders: Very common- Somnolence, dizziness
+- Cardiac disorders: Uncommon- Bradycardia
+- Vascular disorders: Common- Hypotension
+- Gastrointestinal disorders: Very common- Gastrointestinal disorder, dry mouth; Common- Nausea.
+- Musculoskeletal and connective tissue disorders: Very common- Muscular weakness
+- General disorders and administration site conditions: Very common- Fatigue
+- Investigations: Common- Blood pressure decreased, transaminases increased.
+
","As there is limited experience with the use of Tizanidine in pregnant women, it should not be used during pregnancy unless the benefit clearly outweighs the risk.
Animal data: Reproduction studies performed in rats and rabbits did not show evidence of teratogenicity. In rats, dose levels of 10 and 30 mg/kg/day increased gestation duration. Prenatal and postnatal pup loss was increased and development retardation occurred. At these doses, dams showed marked signs of muscle relaxation and sedation. Based on body surface area, these doses were 2.2 and 6.7 times the maximum recommended human dose of 0.72 mg/kg/day.
Lactation: Small amounts of tizanidine are excreted in rat milk. Since no human (fata are available Tizanidine should not be given to women who are breast-feeding.
Females and males of reproductive potential: Pregnancy testing: Sexually-active females of reproductive potential are recommended to have a pregnancy test prior to starting treatment with Tizanidine.
Contraception: Females of reproductive potential should be advised that animal studies have been performed showing Tizanidine to be harmful to the developing fetus. Sexually-active females of reproductive potential are recommended to use effective contraception (methods that result in less than 1 % pregnancy rates) when using Tizanidine during treatment and for 1 day after stopping treatment with Tizanidine.
Fertility: Animal data: No impairment of fertility was observed in male rats at a dose of 10 mg/kg/day, and in female rats at a dose of 3 mg/kg/day. Fertility was reduced in male rats receiving 30 mg/kg/day and in female rats receiving 10 mg/kg/day. Based on body surface area, these doses were 6.7 and 2.2 times the maximum recommended human dose of 0.72 mg/kg. At these doses, maternal behavioral effects and clinical signs were observed including marked sedation, weight loss and ataxia.
","CYP inhibitors: The concomitant use of Tizanidine with moderate CYP1A2 inhibitors is not recommended. Caution should be exercised when Tizanidine is given with drugs known to increase the QT interval.
Hypotension: Hypotension may occur during treatment with Tizanidine and also as a result of drug interactions with CYP1A2 inhibitors and/or antihypertensive drugs. Severe manifestations of hypotension such as loss of consciousness and circulatory collapse have also been observed.
Withdrawal syndrome: Rebound hypertension and tachycardia have been observed after sudden withdrawal of Tizanidine, when it had been used chronically, and/or in high daily dosages, and/or concomitantly with antihypertensive drugs. In extreme cases, rebound hypertension might lead to cerebrovascular accident. Tizanidine should not be stopped abruptly, but rather gradually down titrated.
Hepatic dysfunction: Since hepatic dysfunction has been reported in association with tizanidine, but rarely at daily doses up to 12 mg, it is recommended that liver function tests should be monitored monthly for the first four months in patients receiving doses of 12 mg and higher and in patients who develop clinical symptoms suggestive of hepatic dysfunction, such as unexplained nausea, anorexia or tiredness. Treatment with Tizanidine should be discontinued if serum levels of SGPT or SGOT are persistently above three times the upper limit of the normal range.
Patients with renal impairment: In patients with renal impairment (creatinine clearance <25 mL/min) systemic exposure to tizanidine may increase up to 6 times compared to patient with normal renal function. Therefore, it is recommended to start treatment at 2 mg once daily.
Hypersensitivity reactions: Hypersensitivity reactions including anaphylaxis, angioedema, dermatitis, rash, urticarial, pruritis and erythema have been reported in association with tizanidine. Careful observation of the patient is recommended for one to two days after the first dose is administered. If anaphylaxis or angioedema with anaphylactic shock or difficulty of breathing is observed treatment with Tizanidine should be discontinued immediately and appropriate medical treatment should be instituted.
Driving and using machines: Patients experiencing somnolence, dizziness or any signs or symptoms of hypotension should refrain from activities requiring a high degree of alertness, e.g. driving a vehicle or operating machines.
","Renal impairment (creatinine clearance <25 mL/min): Maximal mean plasma levels were found to be twice as high as in normal volunteers, and the terminal half-life was prolonged to approximately 14 hours, resulting in much higher (approximately 6-fold on average) AUC values.
Hepatic impairment: No specific studies were conducted in this population. As tizanidine is extensively metabolized in the liver by the CYP1A2 enzyme, hepatic impairment may increase its systemic exposure. Tizanidine is contraindicated in patients with severe hepatic impairment.
Geriatrics (65 years of age and older): Pharmacokinetic data in this population are limited.
Gender: Gender has no clinically significant effect on the pharmacokinetics of tizanidine.
Ethnicity: The impact of ethnic sensitivity and race on the pharmacokinetics of tizanidine has not been studied.
","In the few reports of Tizanidine overdosage received, recovery was uneventful, including by a patient who ingested 400 mg Tizanidine. Nausea, vomiting, hypotension, QT(c) prolongation, dizziness, somnolence, miosis, restlessness, respiratory distress, coma. It is recommended to eliminate the ingested drug by repeated administration of high doses of activated charcoal. Forced diuresis is expected to accelerate the elimination of Tizanidine. Further treatment should be symptomatic.
",,,"Store in a dry place below 30°C. Tizanidine must be kept out of the reach and sight of children.
",12
+1192,Titanium dioxide + Butyl methoxydibenzoyl methane + Padimate + Oxybenzone,titanium-dioxide-butyl-methoxydibenzoyl-methane-padimate-oxybenzone-1192,,Sunblock Preparation,Sunblock,"This Lotion is used for the treatment, control, prevention, & improvement of the following diseases, conditions and symptoms:
+
+- Sunburn
+- Premature aging
+- Risk of skin cancer
+- Uv rays protection
+- Dryness and chapping of the lips
+- Cold sores
+- Sun and fever blisters
+
","Sunblock Preparation
","This Lotion improves the patient's condition by performing the following functions:
+
+- Absorbing the sun's ultraviolet radiations.
+- Absorbing sun's ultraviolet radiations.
+- Moisturizing the dry skin area.
+- Diminishing the penetration of UV light through the epidermis
+
","Apply on the area exposed to sunlight (such as face, neck & body) at least 30 min before exposure and whenever necessary. Massage on to skin until absorbed.
To ensure maximum protection, we recommend repeating the application every two hours after continuous exposure to the sun and after swimming, physical exercise (sweat or dry with towel).
",,"There are no known drug interactions and none well documented.
","Hypersensitivity to Spectraban this lotion is a contraindication. In addition, Spectraban Ultra 28 Lotion should not be used if you have the following conditions:
+
+- Allergic reaction
+- Allergic reactions
+- Contact with eyes
+- Hypersensitivity
+
","The following is a list of possible side-effects that may occur from all constituting ingredients of this lotion. This is not a comprehensive list. These side-effects are possible, but do not always occur. Some of the side-effects may be rare but serious. Consult your doctor if you observe any of the following side-effects, especially if they do not go away.
+
+- Rash
+- Itching
+- Severe dizziness
+- Trouble breathing
+- Skin irritation
+- Skin redness
+- Acne
+- Burning or itching of the skin
+- Dark red spots on the skin
+- Painful, red and pus-filled blisters in hair follicles
+
","Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","Before using this lotion, inform your doctor about your current list of medications, over the counter products (e.g. vitamins, herbal supplements, etc.), allergies, pre-existing diseases, and current health conditions (e.g. pregnancy, upcoming surgery, etc.). Some health conditions may make you more susceptible to the side-effects of the drug. Take as directed by your doctor or follow the direction printed on the product insert. Dosage is based on your condition. Tell your doctor if your condition persists or worsens. Important counseling points are listed below.
+
+- Apply it 30 minutes before going in the sun exposure
+- Breastfeeding
+- Herpes infection
+- Infants
+- Planning to have baby
+- Pregnancy
+- Pregnant, planning to become pregnant or breastfeeding
+- Pregnant, planning to get pregnant or breastfeeding
+- Skin disease
+- Do not take by mouth. Consult with your doctor before using this medicine on open wounds, dry, chapped, irritated, or sun-burned skin.
+- Wash your hands before and after applying this lotion. Clean and dry the skin area to be treated.
+- Do not wash the treated area after immediately applying this lotion. Also avoid the use of other products on the treated area unless directed by your doctor.
+- Applying an excessive amount may result in pilling. Use a thinner layer or lesser quantity of medicine to avoid pilling.
+- Avoid getting this medication in your eyes or nose or mouth.
+
",,,,,"Store medicines at room temperature, away from heat and direct light. Do not freeze medicines unless required by package insert. Keep medicines away from children and pets.
",10
+1360,Tiotropium (Dry Powder Inhaler),tiotropium-dry-powder-inhaler-1360,https://medex.com.bd/attachments/v9lBrfC9CPcb67zwqfwMaDWXy6Qb0J/tiotropium-dry-powder-inhaler-prescribing-information,Anticholinergic bronchodilators,Severe bronchospasm,"Tiotropium is indicated for the long-term treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
","Anticholinergic bronchodilators
","Tiotropium is a long-acting, antimuscarinic agent, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors, M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3-receptors at the smooth muscle leading to bronchodilation. The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations. In preclinical in vitro as well as in vivo studies, prevention of methacholine-induced bronchoconstriction effects was dose-dependent and lasted longer than 24 hours. The bronchodilation following inhalation of Tiotropium is predominantly a site-specific effect.
","Adult over 18 years: The recommended dose of Tiotropium Dry Powder Inhaler capsule is 18 mcg (1 capsule) once-daily, with the device.
The contents of the Tiotropium Dry Powder Inhaler capsules are only for oral inhalation and should only be used with the device.
No dosage adjustment is required for geriatric, hepatically-impaired, or renally-impaired patients. However, patients with moderate to severe renal impairment given Tiotropium capsule should be monitored closely for anticholinergic effects.
",,"An interaction study with Tiotroplum (14.4 mcg intravenous infusion over 15 minutes) and cimetidine 400 mg three times daily or ranitidine 300 mg once daily was conducted. Concomitant administration of cimetidine with Tiotroplum resulted in a 20% increase in the AUC 0-4 hour, a 28% decrease in the renal clearance of Tiotroplum and no significant change in the Cmax and amount excreted in urine over 96 hours. Co-administration of Tiotroplum with ranitidine did not affect the pharmacokinetics of Tiotroplum.
","Tiotropium is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, including ipratropium, or to any component of this product.
","The most commonly reported adverse drug reaction was dry mouth. Dry mouth was usually mild and often resolved during continued treatment. Other reactions reported in individual patients and consistent with possible anticholinergic effects included constipation, increased heart rate, blurred vision, glaucoma, urinary difficulty, and urinary retention.
","Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women with Tiotropium. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The safety and effectiveness of Tiotropium has not been studied during labor and delivery.
","As an anticholinergic drug, Tiotropium may potentially worsen symptoms and signs associated with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction and should be used with caution in patients with any of these conditions.
",,"High doses of Tiotropium may lead to anticholinergic signs and symptoms. However, there were no systemic anticholinergic adverse effects following a single inhaled dose of up to 282 mcg Tiotropium in 6 healthy volunteers. In a study of 12 healthy volunteers, bilateral conjunctivitis and dry mouth were seen following repeated once-daily inhalation of 141 mcg of Tiotropium
",,,"Tiotropium Dry Powder Inhaler capsules must not be swallowed. Avoid storage in direct sunlight or heat. Store below 30°C. Keep away from children.
",11
+882,Tropicamide + Phenylephrine Hydrochloride,tropicamide-phenylephrine-hydrochloride-882,,Preparations for Ophthalmic diagnosis,Uveal tract inflammation,"Therapeutic purpose:
+
+- Inflammatory conditions of the uveal tract.
+- May be used in temporary lowering of intraocular pressure in glaucoma.
+
+Diagnostic purpose:
+
+- Retinal photography.
+- Refractive errors.
+- Fundus examination/photography.
... Read more
Therapeutic purpose:
+
+- Inflammatory conditions of the uveal tract.
+- May be used in temporary lowering of intraocular pressure in glaucoma.
+
+Diagnostic purpose:
+
+- Retinal photography.
+- Refractive errors.
+- Fundus examination/photography.
+- Slit lamp examination.
+
+Pre-operative use: In order to undergo surgical procedure that requires the visualization of structures behind the iris, such as cataract extraction, vitrectomy and retinal detachment surgery.
","Preparations for Ophthalmic diagnosis
","Tropicamide binds to and blocks the receptors in the muscles of the eye (muscarinic receptor M4). Tropicamide acts by blocking the responses of the iris sphincter muscle to the iris and ciliary muscles to cholinergic stimulation, producing dilation of the pupil and paralysis of the ciliary muscle.
Phenylephrine Hydrochloride is a selective alpha-1 agonist, which causes mydriasis without cycloplegia. It tends to reduce intraocular lesion by vasoconstrictor action.
","Uveitis: 1-2 drops bid-qid or as required.
Diagnostic purpose/Pre-operative purpose: Instill 1-2 drops in the eye(s) 15-20 minutes before examination. If examination is not conducted within 20–30 minutes, an additional drop may be placed in the eye(s) to prolong the effect.
",,"Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine or ophthalmic cholinesterase inhibitors.
","This medication is contraindicated in these following cases
+
+- Patients with hypersensitivity to any of the components and narrow angles or narrow angle glaucoma.
+- Low birth weight infants and some elderly adults with severe arteriosclerotic cardiovascular or cerebrovascular disease.
+- During intraocular operative procedures when the corneal epithelial barrier has been disturbed.
+
","Elevated IOP (occasionally), stinging, blurred vision, tachycardia, photophobia, headache, parasympathetic stimulation and allergic reactions. Systemic effects include arrhythmias, hypertension and coronary artery spasm.
","The safety of this medication during pregnancy or lactation has not been established.
","Caution should be taken when administered with, or upto 21days after administration of monoamine oxidase (MAO) inhibitors as exaggerated adrenergic effects may result.
The possibility of psychotic reactions and behavioral disturbances should be considered in patients who are hypersensitive to anticholinergic drugs.
Use with extreme caution in infants.
",,"Excessive use in children and in certain susceptible individuals may produce systemic toxic symptoms.
",,,"Keep out of the reach of children. Store in a cool, dry place, away from heat and direct light. Do not use more than 4 weeks after opening.
",11
+2039,Tropicamide + Phenylephrine + Lidocaine,tropicamide-phenylephrine-lidocaine-2039,https://medex.com.bd/attachments/OMJg9dtFkLmHG1u0GKTP9Hdf0FnpGI/tropicamide-phenylephrine-lidocaine-prescribing-information,Other ophthalmic preparations,Mydriasis,"This is indicated for cataract surgery to obtain mydriasis (dilation of the pupil) and intraocular anesthesia during the surgical procedure.
","Other ophthalmic preparations
",,"Used only in the elderly and adults undergoing cataract surgery. The injection has to be administered by an ophthalmic surgeon, under local anesthesia, at the beginning of cataract surgery. The recommended dose is 0.2 ml of solution, in only one injection. The following procedure should be followed:
+
+- Five minutes before performing the preoperative antiseptic procedure and the first incision, one to two drops of anesthetic eye drops should be instilled in the eye.
+- At the beginning of surgery, 0.2 ml of the drop is slowly injected in only one injection via intracameral route, through the side port or principal port.
+
",,,,"Most serious well-known complications occurring during or after cataract surgery:
Uncommon: may affect up to 1 in 100 people
+
+- Injury to the lens (posterior capsule rupture)
+- Swelling of the retina (cystoid macular edema)
+
+Please seek urgent medical advice in this case.
Other side effects:
Uncommon: may affect up to 1 in 100 people
+
+- Nervous system disorder: Headache
+- Eye Disorder: Swelling of the cornea (keratitis), increased pressure in the eye, redness of the eye (ocular hyperaemia)
+- Vascular disorder: High blood pressure (hypertension)
+
","This medicine should not be used during pregnancy and lactation.
","Do not use if the blister is damaged or broken. Open under aseptic conditions only. The product should be used immediately after opening of the ampoule and not be reused for the other eye or any other patient. This is not recommended:
+
+- In combined cataract surgery with a certain type of eye surgery (vitrectomy)
+- If the ocular anterior chamber is shallow
+- If the patient has a history of acute narrow angle glaucoma
+
+The doctor should consider the patient’s medical condition if he is suffering from hypertension, atherosclerosis or any kind of heart disease, hyperthyroidism, prostate gland disorders, epilepsy, any liver disease or kidney problem, breathing problem or myasthenia gravis.
",,,,,"Do not store above 30⁰C. Does not require refrigeration. Keep away from light and out of the reach of children. For single eye use only. This medicine should be used immediately after first opening of the ampoule. After use, discard the remaining solution appropriately. Do not keep it for subsequent use.
",7
+1109,Tropicamide,tropicamide-1109,https://medex.com.bd/attachments/HfmHHuO9BFESUSlj24RjDmnr0yxQlq/tropicamide-prescribing-information,Mydriatic and Cycloplegic agents,Uveitis,"For mydriasis and cycloplegia for diagnostic procedure, for the treatment of acute and subacute iridocyclitis, chronic iridocyclitis, Adhesions and disruptions of iris and ciliary body, Sclera and iris operations
","Mydriatic and Cycloplegic agents
","Tropicamide binds to and blocks the receptors in the muscles of the eye (muscarinic receptor M4). Tropicamide acts by blocking the responses of the iris sphincter muscle to the iris and ciliary muscles to cholinergic stimulation, producing dilation of the pupil and paralysis of the ciliary muscle.
","For refraction: Instill one or two drops of 1% solution in the eye(s), repeated in five minutes. If patient is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong mydriatic effect.
For examination of fundus: Instill one or two drops of 0.5% solution 15 to 20 minutes prior to examination. Individuals with heavily pigmented irides may require higher strength or more doses.
",,"Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
","Contraindicated in persons showing hypersensitivity to any component of this preparation.
","Transient stinging, blurred vision, photophobia and superficial punctate keratitis have been reported with the use of tropicamide. Increased intraocular pressure has been reported following the use of mydriatics. Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide.
","Pregnancy Category C. Tropicamide should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when tropicamide is administered to a nursing woman.
","The lacrimal sac should be compressed by digital pressure for 2-3 minutes after instillation to avoid excessive systemic absorption.
",,,,,"Store at 15° to 25°C . Do not refrigerate or store at high temperatures. Keep container tightly closed.
",10
+1265,Trimipramine,trimipramine-1265,https://medex.com.bd/attachments/VjE5YLkEFNyi6PFwZeH0rIyb7WQ8KN/trimipramine-prescribing-information,Tricyclic & related anti-depressant drugs,Depression,"This medication is used to treat depression. It may help improve your mood and sense of well-being and allow you to enjoy everyday life more. Trimipramine is a tricyclic antidepressant. It works by restoring the balance of certain natural substances (neurotransmitters) in the brain.
","Tricyclic & related anti-depressant drugs
","Trimipramine is a tricyclic antidepressant. It was thought that tricyclic antidepressants work by inhibiting the re-uptake of the neurotransmitters norepinephrine and serotonin by nerve cells. However, this response occurs immediately, yet mood does not lift for around two weeks. It is now thought that changes occur in receptor sensitivity in the cerebral cortex and hippocampus. The hippocampus is part of the limbic system, a part of the brain involved in emotions. Presynaptic receptors are affected: a1 and b1 receptors are sensitized, a2 receptors are desensitised (leading to increased noradrenaline production). Tricyclics are also known as effective analgesics for different types of pain, especially neuropathic or neuralgic pain. A precise mechanism for their analgesic action is unknown, but it is thought that they modulate anti-pain opioid systems in the CNS via an indirect serotonergic route. They are also effective in migraine prophylaxis, but not in abortion of acute migraine attack. The mechanism of their anti-migraine action is also thought to be serotonergic.
","Adult: Initially 50-75 mg daily, increased gradually as necessary to 150-300 mg daily. May be given in divided doses during the day or as a single dose at night.
Elderly: Initial 50-75 mg daily, increased gradually if necessary. Max: 100 mg daily.
","May be taken with or without food
","Decreased antihypertensive effects of guanethidine, guanfacine, debrisoquine, betanidine and possibly clonidine. Increased CNS depression with CNS depressants such as alcohol, sedatives, hypnotics or barbiturates. Increased trimipramine levels with protease inhibitors, SSRIs, selegiline, tramadol, quinidine, diltiazem and verapamil. Decreased trimipramine levels with barbiturates. Increased risk of arrhythmias with drugs that prolong QT intervals. Increased risk of serotonin syndrome with linezolid. Increased antimuscarinic adverse effects with nefopam. Risk of neurotoxicity and serotonin syndrome with lithium.
","Recent MI, cardiac arrhythmias, heart block; mania; porphyria, severe liver disease. Neonates and children. Lactation.
","Dry mouth, accommodation disturbances, tachycardia, constipation, hesitancy of micturation, drowsiness, sweating, postural hypotension, skin rashes, cholestatic jaundice, hypomania, convulsions, cardiac arrhythmias and peripheral neuropathy. Agitation, confusion (elderly).
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Narrow-angle glaucoma; prostatic hypertrophy; history of epilepsy; hyperthyroidism; patients requiring anaesthesia. Pregnancy. Withdraw gradually to decrease risk of withdrawal symptoms. Monitor liver function in long term treatment. May impair ability to drive or operate machinery.
",,"Symptoms: Hypotensive collapse, convulsions, cardiac arrhythmias, acidosis and coma.
Management: Gastric lavage should be carried out as soon as possible. Treatment is supportive and symptomatic with ECG monitoring. Intubate and ventilate the patient before convulsions develop. If convulsions occur, treat with IV diazepam. Treatment should be continued for at least 3 days even if the patient appears to have recovered, due to the long half life of trimipramine.
",,,,11
+1108,Trimetazidine Dihydrochloride,trimetazidine-dihydrochloride-1108,https://medex.com.bd/attachments/piyZuyHOhgbBgqSKHIJiVFr4zSaGCq/trimetazidine-dihydrochloride-20-mg-tablet-prescribing-information,Other Anti-anginal & Anti-ischaemic drugs,Meniere’s disease,"Trimetazidine Dihydrochloride is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line antianginal therapies.
","Other Anti-anginal & Anti-ischaemic drugs
","Trimetazidine Dihydrochloride is the first 3- keto acyl CoA thiolase inhibitor (KAT), a metabolic anti-ischemic agent with proven benefits for all coronary patients. Trimetazidine Dihydrochloride inhibits fatty acid pathway by inhibiting 3-keto acyl CoA thiolase enzyme and transfers oxygen to glucose pathway. Since glucose pathway is more efficient in producing energy, the same oxygen produces more energy and makes the heart more active. Moreover, the aerobic oxidation of glucose stops production of lactic acid, which prevents angina pectoris.
","The recommended dose of Trimetazidine is 35 mg twice daily or 20 mg tablet thrice daily during meals. The benefit of the treatment should be assessed after three months and Trimetazidine should be discontinued if there is no treatment response.
",,"No drug interaction so far has been reported. In particular, no interaction has been reported with beta-blockers, calcium antagonists, nitrates, heparin, hypolipidemic agents or digitalis preparation.
","Trimetazidine is contraindicated in patients who have hypersensitivity to the active substance or to any of the excipients. It is also is contraindicated in patients with Parkinson’s disease, parkinsonian symptoms, tremors, restless legs movement disorders, severe renal impairment.
","Trimetazidine is safe and well tolerated. The Common side effects associated with Trimetazidine are dizziness, headache, abdominal pain, diarrhoea, dyspepsia, nausea, vomiting, rash, pruritus, urticaria and asthenia
","There is no data on the use of Trimetazidine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Trimetazidine during pregnancy. It is unknown whether Trimetazidine is excreted in human milk. A risk to the newborns/infants cannot be excluded. Trimetazidine should not be used during breast-feeding.
","Trimetazidine is not a curative treatment for angina attacks, nor an initial treatment for unstable angina pectoris. It is also not a treatment for myocardial infarction.
",,,,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",10
+1107,Trimebutine Maleate,trimebutine-maleate-1107,https://medex.com.bd/attachments/Hmb9FDQ6cbBnla3xd4iE482MTWq9oF/trimebutine-maleate-prescribing-information,Anticholinergics,Paralytic ileus and post-operative urinary retention,"Treatment and relief of symptoms associated with irritable bowel syndrome (spastic colon). Postoperative paralytic ileus in order to accelerate the resumption of the intestinal transit following abdominal surgery.
","Anticholinergics
","Trimebutine maleate is a noncompetitive spasmolytic agent. It possesses moderate opiate receptor affinity and has marked anti-serotonin activity especially on 'mu' receptors. It induces regulation of spontaneous activity and increases synchronization between electrophysiological spikes and contractions in isolated guinea pig strips of colon and ileum. However, it does not alter normal motility, but regulates abnormal intestinal activity.
","For adults: 100 mg to 200 mg, 3 times per day before meals.
",,"Trimebutine maleate increases the duration of d-tubocurarine-induced curarization. No other druginteractions have been observed during clinical trial or otherwise reported.
","Patients with known hypersensitivity to trimebutine maleate or any excipient.
","Trimebutine maleate is generally well tolerated. The infrequently reported adverse effects are as follows: dry mouth, foul taste, diarrhea, dyspepsia, epigastric pain, nausea, constipation, drowsiness, fatigue, dizziness, hot/cold sensations, headache etc.
","Although teratological studies have not shown any drug related adverse effects on the course and outcome of pregnancy, the use of trimebutine maleate in pregnant women is not recommended.
It is not known if trimebutine maleate passes into breast milk. This medication should be used while breast feeding only if the potential benefits outweigh risks to the nursing infants.
","Elderly, pregnancy and lactation
",,"No evidence of overdosage have been reported to date. However, if overdosage should occur following oral administration, gastric lavage is recommended. Treatment should be made according to the symptoms observed.
",,,"Store in a cool and dry place, protected from light and moisture. Keep out of the reach of children.
",11
+1106,Trihexyphenidyl Hydrochloride,trihexyphenidyl-hydrochloride-1106,https://medex.com.bd/attachments/CO9NcuFfk6zyQf2zCGYTi7BkVfkaOU/trihexyphenidyl-hydrochloride-prescribing-information,Antiparkinson drugs,Parkinsonism,"Trihexyphenidyl Hydrochloride is indicated as an adjunct treatment of all forms of parkinsonism (postencephalitic, arteriosclerotic & idiopathic). Additionally, it is indicated for the control of extrapyramidal disorders caused by central nervous system drugs such as dibenzoxazepines, phenothiazines, thioxanthenes & butyrophenones.
","Antiparkinson drugs
","Trihexyphenidyl is a non-selective muscarinic acetylcholine receptor antagonist but binds with higher affinity to the M1 subtype. In vivo studies have shown that trihexyphenidyl demonstrates higher affinity for central muscarinic receptors located in the cerebral cortex and lower affinity for those located peripherally. Other studies suggest that trihexyphenidyl may modify nicotinic acetylcholine receptor neurotransmission, leading indirectly to enhanced dopamine release in the striatum. Although the anticholinergic has proven to be useful in the treatment of symptoms associated with Parkinson’s disease or other movement disorders, its mechanism of action has yet to be fully elucidated.
","Dosage should be individualized. The initial dose should be low and then increased gradually, especially in patients over 60 years of age. Whether Trihexyphenidyl may best be given before or after meals should be determined by the way the patient reacts.
Idiopathic Parkinsonism: 1 mg of Trihexyphenidyl may be administered the first day. The dose may then be increased by 2mg increments at intervals of three to five days.
Drug-Induced Parkinsonism: Commence therapy with a single 1 mg dose increase the total daily dosage to 5-15 mg range if the extrapyramidal manifestations are not controlled.
Concomitant Use with Levodopa: When Trihexyphenidyl is used concomitantly with levodopa, the usual dose is 3-6 mg daily.
",,"Cannabinoids, barbiturates, opiates, and alcohol may have additive effects with Trihexyphenidyl, and thus, an abuse potential exists. Concurrent use of alcohol or other CNS depressants with Trihexyphenidyl may cause increased sedative effects. It may be contraindicated in patients taking monoamine oxidase inhibitors & tricycllic antidepressants.
","Contraindicated in patients with hypersensitivity to Trihexyphenidyl HCI or to any of the tablet or elixir ingredients. Trihexyphenidyl is also contraindicated in patients with narrow angle glaucoma. Blindness after long-term use due to narrow angle glaucoma has been reported.
","Minor side effects such as dryness of the mouth, blurring of vision, dizziness, mild nausea or nervousness. Patients with arteriosclerosis or with a history of idiosyncrasy to other drugs may exhibit reactions of mental confusion, agitation, disturbed behavior, or nausea and vomiting. Potential side effects are constipation, drowsiness, urinary hesitancy or retention, pupil dilation, increased intraocular tension, vomiting and headache.
","Pregnancy Category C. It is not known whether the drug is excreted in human milk and therefore Trihexyphenidyl should only be used if the expected benefit to the mother outweighs the potential risk to the infant.
","Patients with cardiac, liver, or kidney disorders, or with hypertensioon, should closely be monitored. Since Trihexyphenidyl HCI has parasympatholytic activity, it should be used with caution in patients with glaucoma, obstructive disease of the gastrointestinal or genitourinary tracts, and in elderly males with possible prostatic hypertrophy. Trihexyphenidyl is not recommended for use in patients with tardive dyskinesia unless they have concomitant Parkinson’s disease. Abrupt withdrawal of treatment for parkinsonism may result in acute exacerbation of parkinsonism symptoms; therefore, abrupt withdrawal should be avoided.
",,"Overdosage with Trihexyphenidyl produces typical central symptoms of atropine intoxication (the central anticholinergic syndrome). Signs & symptoms are: dilated and sluggish pupils, warm, dry skin, facial flushing, decreased secretions of mouth, pharynx, nose and bronchi, foul smelling breath, tachycardia etc. Neuropsychiatric signs such as delirium, disorientation, anxiety, hallucinations etc. The condition can progress to stupor, coma, paralysis, cardiac, respiratory arrest and death.
",,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",11
+1105,Trifluridine,trifluridine-1105,https://medex.com.bd/attachments/Qd7KNq0kdm0H671mLx2QIEX4PgpELM/trifluridine-prescribing-information,Ophthalmic Anti-viral Products,Keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex viruses,"Trifluridine Sterile Eye Drops is indicated for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, type 1 and 2.
","Ophthalmic Anti-viral Products
","Trifluridine is a fluorinated pyrimidine nucleoside analog which interferes with DNA synthesis of herpes simplex virus, type 1 and 2 and vaccinia virus. It stops replication of herpes viral DNA in 3 ways:
+
+- Competitive inhibition of viral DNA polymerase,
+- Incorporation into and termination of the growing viral DNA chain and
+- Inactivation of the viral DNA polymerase.
+
","Children above 6 years of age & adults: Instill 1 drop every 2 hrs while awake; maximum 9 drops/day until the corneal ulcer has completely re-epithelialized.
After re-epithelialization: Instill 1 drop every 4 hrs or at least 5 drops/day for 7 days is recommended. If there are no signs of improvement after 7 days of therapy or complete re-epithelialization has not occurred after 14 days of therapy, other forms of therapy should be considered. Continuous administration of Trifluridine eye drops for periods exceeding 21 days should be avoided because of potential ocular toxicity.
",,,"Contraindicated in patients who develop hypersensitivity reactions or chemical intolerance to Trifluridine.
","Reported side effects are mild, transient burning or stinging sensation upon instillation. Other side effects are superficial punctate keratopathy, epithelial keratopathy, hypersensitivity reaction, stromal edema, irritation, keratitis sicca, hyperemia and increased intraocular pressure.
","Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Trifluridine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is unlikely that Trifluridine is excreted in human milk after instillation of Trifluridine eye drops because of the relatively small dosage. The drug should not be prescribed for nursing mothers unless the potential benefits outweigh the potential risks.
","Trifluridine should be prescribed only for patients who have a clinical diagnosis of herpetic keratitis.
","Use in children: Safety and effectiveness in pediatric patients below 6 years of age have not been established.
Use in elderly patients: No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.
",,,,,9
+1104,Trifluoperazine,trifluoperazine-1104,https://medex.com.bd/attachments/64qRZc3Z4eqzYwTc8rP08P8uA2mXeQ/trifluoperazine-prescribing-information,Phenothiazine drugs,Schizophrenia,"Anxiety states: It controls excessive anxiety, tension, and agitation seen in neuroses or associated with somatic conditions. The treatment or prevention of nausea and vomiting of various causes. The management of psychotic disorders, such as acute or chronic catatonic, hebephrenic ... Read more
Anxiety states: It controls excessive anxiety, tension, and agitation seen in neuroses or associated with somatic conditions. The treatment or prevention of nausea and vomiting of various causes. The management of psychotic disorders, such as acute or chronic catatonic, hebephrenic and paranoid schizophrenia; psychosis due to organic brain damage, toxic psychosis, and the manic phase of manic-depressive illness.
","Phenothiazine drugs
","Trifluoperazine is one of the phenothiazine class of compounds and as such has many pharmacodynamic effects which relate to its therapeutic actions and side effects. The most notable action of phenothiazines is antagonism at dopamine receptors in the CNS. It is hypothesised that this action in the limbic system and associated areas of cerebral cortex is the basis of the antipsychotic action of phenothiazines, whilst in the medullary chemoreceptor trigger zone it appears to be responsible for the antiemetic effect of these agents.
","Schizophrenia and other psychoses:
+
+- Adults and child over 12 years: Recommended starting dose is 2-5 mg b.i.d, increased by 5 mg daily after 1 week then at interval of 3 days, according to response.
+- Children (6-12 years): Dosage should be adjusted to the weight of the child and severity of the symptoms. The starting dosage is 1 mg b.i.d. Dosage may be increased gradually until symptoms are controlled or until side effects become troublesome. While it is usually not necessary to exceed dosages of 15 mg daily.
+- Elderly: Reduce initial dose by at least half
+
+Short-term management of severe anxiety:
+
+- Adult and child over 12 years: 1-2 mg b.i.d, increased if necessary to 6 mg daily.
+- Child (3-5 years): 1 mg daily
+- Child (6-12 years): Up to 4 mg daily in divided dose.
+- Elderly: Reduce initial dose by at least half
+
+Antiemetic:
+
+- Adult: 2-4 mg daily in divided doses; max. 6 mg daily;
+- Child 3-5 years: up to 1 mg daily, 6-12 years up to 4 mg daily.
+
",,"Trifluoperazine may diminish the effect of oral anticoagulants. Concomitant administration of propranolol with trifluoperazine results in increased plasma levels of both drugs. Antihypertensive effects of guanethidine and related compounds may be counteracted when phenothiazines are used concurrently. Potentiation may occur if antipsychotic drugs are combined with CNS depressants such as alcohol. hypnotics and anticonvulsant.
","Do not use Trifluoperazine in comatose patients, or in those with existing blood dyscrasias or known liver damage, or in those hypersensitive to the active ingredient or related compounds.
","Common side effects are transient restlessness, dystonias or may resemble parkinsonism. Other CNS Reactions are drowsiness, dizziness, fatigue, blurred vision, seizures. Without these Peripheral oedema, blood dyscrasias, jaundice may occasionally occur. Tachycardia, constipation, urinary hesitancy and retention and hyperpyrexia have been reported very rarely.
","Pregnancy: Safety for the use of trifluoperazine during pregnancy has not been established. Therefore, it is not recommended that the drug be given to pregnant patients except when, in the judgement of the physician, it is essential. The potential benefits should clearly outweigh possible hazards. There are reported instances of prolonged jaundices, extrapyramidal signs, hyperreflexia or hypoflexia in newborn infants whose mother received phenothiazines.
Lactation: Adequate human data are not available in case of lactation.
","Care should be taken when treating elderly patients, and initial dosage should be reduced. Such patients can be specially sensitive, particularly to extra pyramidal and hypotensive effects. Patients with cardiovascular disease including arrhythmias should also be treated with caution. Care should be taken in patients with angina pectoris.
",,"Signs and symptoms will be predominantly extrapyramidal; hypotension may occur. Treatment consists of gastric lavage together with supportive and symptomatic measures. Do not induce vomiting. Extra pyramidal symptoms may be treated with an anticholinergic, antiparkinsonism drug. Treat hypotension with fluid replacement; if severe or persistent. nor adrenaline may be considered. Adrenaline is contraindicated.
",,,"It should be store at room temperature between 15-30° C away from light and moisture.
",11
+1878,Trifarotene,trifarotene-1878,https://medex.com.bd/attachments/I4jZDUye0rkjV6H3TKFEE8GVL5a8rQ/trifarotene-prescribing-information,Topical retinoid and related preparations,Acne vulgaris,"Trifarotene cream is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
","Topical retinoid and related preparations
","Trifarotene is an agonist of retinoic acid receptors (RAR), with particular activity at the gamma subtype of RAR. Stimulation of RAR results in modulation of target genes which are associated with various processes, including cell differentiation and mediation of inflammation. The exact process by which Trifarotene ameliorates acne is unknown.
","Apply a thin layer of Trifarotene cream to the affected areas once daily, in the evening, on clean and dry skin. The use of a moisturizer is recommended as frequently as needed from the initiation of treatment. Avoid contact with the eyes, lips, paranasal creases, mucous membranes. Trifarotene cream is intended for topical use only. Not for oral, ophthalmic or intravaginal use.
",,"Topical application of Trifarotene cream is not expected to affect the circulating concentrations of oral hormonal contraceptives containing ethinylestradiol and levonorgestrel.
",,"Most common adverse reactions (incidence >1%) in patients treated with Trifarotene cream were application site irritation, application site pruritus, and sunburn.
","Pregnancy Category C. Available data from clinical trials with Trifarotene cream use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Trifarotene cream and any potential adverse effects on the breastfed infant from Trifarotene cream or from the underlying maternal condition.
","Skin irritation: Patients using Trifarotene cream may experience erythema, scaling, dryness and stinging/burning. Maximum severity of these reactions typically occurred within the first 4 weeks of treatment, and severity decreased with continued use of the medication. Depending upon the severity of these adverse reactions, instruct patients to use a moisturizer, reduce the frequency of application of Trifarotene cream, or suspend use temporarily. If severe reactions persist the treatment may be discontinued. Avoid application of Trifarotene cream to cuts, abrasions, or eczematous or sunburned skin. Use of ""waxing"" as a depilatory method should be avoided on skin treated with Trifarotene cream.
Ultraviolet Light and Environmental Exposure: Minimize unprotected exposure to ultraviolet rays (including sunlight and sunlamps) during treatment with Trifarotene cream. Warn patients who normally experience high levels of sun exposure and those with inherent sensitivity to sun to exercise caution. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided.
","Pediatric Use: Safety and effectiveness of Trifarotene cream have not been established in pediatric patients below the age of 9 years.
Geriatric Use: Clinical trials of Trifarotene cream did not include any subjects aged 65 years and over to determine whether they respond differently than younger subjects.
",,,,"Do not store above 25°C. Protect from light. Keep out of reach of children.
",10
+1103,Triamcinolone Acetonide (Topical),triamcinolone-acetonide-topical-1103,,Corticosteroid,Psoriasis,"is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses including atopic dermatitis, contact dermatitis, eczematous dermatitis, neurodermatitis, seborrheic dermatitis, insect bites, lichen simplex chronicus, exfoliative dermatitis, stasis dermatitis, nummular eczema, psoriasis and pruritus ani and vulvae.
","Corticosteroid, Glucocorticoids, Triamcinolone & Combined preparations
","Triamcinolone Acetonide (a derivative of Triamcinolone) in a compatible base. Topical steroids are primarily effective because of their anti-inflammatory, antipruritic & vasoconstrictive actions.
","A small amount of Triamcinolone is gently rub to the affected area 1-2 times daily. Some cases of eczematised psoriasis may be treated more effectively by the application of Triamcinolone under an occlusive dressing.
Occlusive dressing technique: Gently rub a small amount of Triamcinolone on the lesion until it disappears. Then reapply, leaving a thin coating and cover with a pliable non porous film. For convenience apply Triamcinolone intermittently (12 hour occlusion during the night) followed by reapplication without occlusion, during the day.
Pediatric use: Triamcinolone should not be used in children under 8 years. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children. As children are more likely to get side effects, they should not normally be treated for longer than 5 days.
",,,"Triamcinolone Acetonide is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. It is also contraindicated in tuberculosis of the skin, fungus infections and viral diseases of the skin (Herpes simplex, chickenpox and vaccinia), perioral dermatitis, rosacea and ulcerative conditions.
","The following local side effects have been reported with topical corticosteroids, either with or without occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis and allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
","There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroid should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether topical administration of corticosteroid could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.
","If reactions or idiosyncrasies are encountered, Triamcinolone Acetonide should be discontinued. The use of topical steroids on infected areas should be attended with caution and careful observation, bearing in mind the potential spreading of infections by anti-inflammatory steroids and the possible advisability of discontinuing steroid therapy and/or initiating antibacterial measures.
Triamcinolone Acetonide should not be used on healthy skin or over large areas of skin and not to be used in the eye as there is potential risk of glaucoma and cataract. When steroids are applied for long periods of time (more than 4 weeks) the occurrence of atrophic striae is likely. Prolonged use on flexures and intertriginous areas is undesirable. Children may absorb proportionately larger amounts of topical corticosteroids and thus may be more susceptible to systemic toxicity. In infants, long term continuous topical steroid therapy should be avoided. Adrenal suppression can occur even without occlusion.
",,"Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects e.g., mild, reversible suppression of adrenal function, ecchymoses of the skin, peptic ulceration, hypertension, aggravation of infection, hirsutism, acne, edema and muscle weakness
",,,"Store in a cool & dry place. Protect from light.
",10
+1362,Triamcinolone Acetonide (Nasal Spray),triamcinolone-acetonide-nasal-spray-1362,https://medex.com.bd/attachments/4JOjaeyduWhS3z8QAP3WnjCBw680vF/triamcinolone-acetonide-nasal-spray-prescribing-information,Corticosteroid,Perennial or seasonal allergic rhinitis,"Triamcinolone is indicated for the treatment and prophylaxis of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 6 years of age and older.
","Corticosteroid, Glucocorticoids, Nasal Steroid Preparations
","The antiinflammatory actions of corticosteroids are thought to involve lipocortins, phospholipase A2 inhibitory proteins which, through inhibition of arachidonic acid, control the biosynthesis of prostaglandins and leukotrienes. Firstly, however, these glucocorticoids bind to the glucocorticoid receptors which translocate into the nucleus and bind DNA (GRE) and change genetic expression both positively and negatively. The immune system is suppressed by corticosteroids due to a decrease in the function of the lymphatic system, a reduction in immunoglobulin and complement concentrations, the precipitation of lymphocytopenia, and interference with antigen-antibody binding.
Triamcinolone Acetonide is a more potent derivative of Triamcinolone and is approximately 8 times more potent than prednisone. Corticosteroids are very effective in the treatment of allergic diseases in man. When given by intranasal spray, Triamcinolone Acetonide provides relief from allergy-induced watery nasal discharge (rhinorrhea), nasal congestion, postnasal drip, sneezing, and itching of the back of the throat.
","Adults and children 12 years of age and older: The recommended dose is 220 µgm as 2 sprays in each nostril once daily. Once symptoms are controlled patients can be maintained on 110 µgm (1 spray in each nostril once daily). The minimum effective dose should be used to ensure continued control of symptoms.
Pediatric Patients aged 6 to 12 years: The recommended dose is 110 µgm as 1 spray in each nostril once daily. Triamcinolone spray is not recommended for children under 6 years of age.
","How to use the Nasal Spray-
+
+- Shake the bottle gently and remove the dust cover.
+- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
+- Gently blow the nose to clear the nostrils.
+- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
+- Breathe out through your mouth.
+- Repeat the above steps in the same/ other nostril for consecutive doses.
+
+Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-
+
+- Remove the dust cover.
+- Gently pull off the nasal applicator.
+- Wash the applicator and dust cover in warm water.
+- Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
+- Gently push the applicator back on the top of the bottle and re-fix the dust cover.
+
",,"No specific contraindications but caution is required in patients with hypersensitivity to any constituents of the formulation.
","The most commonly reported adverse reactions in clinical trials with Triamcinolone included those involving mucous membranes of the nose & throat. The most prevalent adverse reactions considered are rhinitis, headache, & pharyngitis. The nasopharyngeal adverse effects included epistaxis, nasal irritation, dry mucous membrane, naso-sinus congestion and sneezing although these are seen as frequently with placebo. As with other nasally inhaled corticosteroids, nasal septal perforation has been reported.
","There are no adequate and well controlled studies in pregnant women with Triamcinolone. Because animal studies indicate a teratogenic effect, Triamcinolone should be used during pregnancy if the potential benefit justifies the potential benefit to fetus. It is not known whether Triamcinolone is excreted in human breast milk.
","If there is any reason to suppose that adrenal function is impaired, care must be taken while transferring patients from systemic steroid treatment to Triamcinolone. In clinical studies with Triamcinolone administered intranasally, the development of localized infections, on the nose, and pharynx with Candida albicans, has rarely occurred. When such an infection develops it may require treatment with appropriate local therapy and discontinuance of treatment with Triamcinolone. Because of the inhibitory effect of corticosteroids on wound healing in patients who have experienced recent nasal septal ulcers, nasal surgery of trauma, Triamcinolone should be used with caution until healing has occurred.
",,"Like any other nasally administered corticosteroid, acute overdosing with Triamcinolone is unlikely in view of the total amount of active ingredient present
",,,"Store at a temperature not exceeding 25˚C. Protect from light and moisture. Keep out of the reach of children.
",11
+1361,Triamcinolone Acetonide (Injection),triamcinolone-acetonide-injection-1361,https://medex.com.bd/attachments/HvVkXp24GLV0SD7zwBnSc0izbMBhoW/triamcinolone-acetonide-injection-prescribing-information,Corticosteroid,Severe erythema multiforme (Stevens-Johnson syndrome),"Post-traumatic osteoarthritis, synovitis of osteoarthritis, rheumatoid arthritis, acute and sub-acute bursitis, epicondylitis, acute non-specific tenosynovitis, acute gouty arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile rheumatoid arthritis, pemphigus, severe erythema multiforme (Stevens-Johnson ... Read more
Post-traumatic osteoarthritis, synovitis of osteoarthritis, rheumatoid arthritis, acute and sub-acute bursitis, epicondylitis, acute non-specific tenosynovitis, acute gouty arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile rheumatoid arthritis, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, bullous dermatitis herpetiformis, severe seborrheic dermatitis, severe psoriasis, bronchial asthma, contact dermatitis, atopic dermatitis, seasonal or perennial allergic rhinitis.
","Corticosteroid, Glucocorticoids, Triamcinolone & Combined preparations
","The antiinflammatory actions of corticosteroids are thought to involve lipocortins, phospholipase A2 inhibitory proteins which, through inhibition of arachidonic acid, control the biosynthesis of prostaglandins and leukotrienes. Firstly, however, these glucocorticoids bind to the glucocorticoid receptors which translocate into the nucleus and bind DNA (GRE) and change genetic expression both positively and negatively. The immune system is suppressed by corticosteroids due to a decrease in the function of the lymphatic system, a reduction in immunoglobulin and complement concentrations, the precipitation of lymphocytopenia, and interference with antigen-antibody binding.
","Adults and children over 12 years of age: Initial dose is 60 mg. Dosage is usually adjusted within the range of 40 to 80 mg. For local areas, dose for adults is up to 10 mg for smaller areas and up to 40 mg for larger areas.
Children 6 to 12 years: Initial dose is 40 mg
",,"Aminoglutethimide: Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression.
Amphotericin B injection and potassium-depleting agents: When corticosteroids are administered concomitantly with potassium-depleting agents (ie, amphotericin B, diuretics), patients should be observed closely for development of hypokalemia. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.
Antibiotics: Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance.
Anticholinesterases: Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.
Anticoagulants, oral: Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.
Antidiabetics: Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.
Antitubercular drugs: Serum concentrations of isoniazid may be decreased.
Cholestyramine: Cholestyramine may increase the clearance of corticosteroids.
Cyclosporine: Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.
Digitalis glycosides: Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.
Estrogens, including oral contraceptives: Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.
Hepatic enzyme inducers (eg, barbiturates, phenytoin, carbamazepine, rifampin): Drugs which induce hepatic microsomal drug metabolizing enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased.
Ketoconazole: Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to an increased risk of corticosteroid side effects.
Nonsteroidal anti-inflammatory drugs (NSAIDs): Concomitant use of aspirin (or other nonsteroidal anti-inflammatory drugs) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids.
Skin tests: Corticosteroids may suppress reactions to skin tests.
Vaccines: Patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible.
","Triamcinolone Acetonide injection is contraindicated in patients with a sensitivity to the active or inactive ingredients.
","Cushingoid syndrome, weakness, bruising or purpura, aggravation of infections, peptic ulcer, activation of latent or aggravation of existing diabetes, altered menstrual cycle, hirsutism.
","Triamcinolone Acetonide injection should be used during pregnancy, nursing mothers if the possible benefits of the medication justify the potential hazards to the fetus or nursing infant.
","Triamcinolone Acetonide injection should be used cautiously in patients with ocular herpes simplex, nonspecific ulcerative colitis, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, Cushing's syndrome, diabetes mellitus, congestive heart failure, chronic nephritis.
","Use in the elderly: The common adverse effects of systemic corticosteroids such as osteoporosis or hypertension may be associated with more serious consequences in old age. Close clinical supervision is recommended.
Use in children: As corticosteroids can suppress growth, the development of infants and children on prolonged corticosteroid therapy should be carefully observed. Caution should be taken in the event of exposure to chicken pox, measles or other communicable diseases. Children should not be vaccinated or immunized while on corticosteroid therapy. Corticosteroids may also affect endogenous steroid production.
","Treatment of acute overdosage is by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage of the corticosteroid may be reduced only temporarily, or alternate day treatment may be introduced.
",,,"Store at controlled room temperature, 20-25°C, avoid freezing and protect from light.
",12
+558,Triamcinolone + Neomycin + Nystatin + Gramicidin,triamcinolone-neomycin-nystatin-gramicidin-558,,Triamcinolone & Combined preparations,Superficial bacterial infections,"This medication is a combination antibiotic and steroid used on the skin to treat an infection and relieve associated itching and swelling.
","Triamcinolone & Combined preparations
","Triamcinolone is a fluorinated corticosteroid with anti-inflammatory, antipruritic and anti-allergic actions.
Nystatin, a polyene antifungal antibiotic, binds to ergosterol and interferes with the permeability of cell membrane of susceptible fungi e.g Candida spp.
Neomycin is an aminoglycoside, often used topically in the infections against susceptible staphylococci and other organisms.
Gramicidin, an antibacterial substance extracted from tyrothricin, is active against many Grampositive bacteria. Used together, this combination provides a wide coverage against gram-positive, gram-negative bacteria and yeast which are responsible for most of the skin infections.
","This medication is for use on the skin only. Wash your hands before using. Avoid getting this product in your eyes or inside the mouth. If this occurs, wipe off the medication and rinse thoroughly with water. Do not use inside the nose unless directed by your doctor.
Clean and dry the affected area as directed. Apply a small amount of medication in a thin layer on the skin and rub in gently, usually 2 to 3 times daily or as directed by your doctor. Wash your hands after use.
Do not bandage, wrap, or cover the treated area unless you are instructed to do so by your doctor. If this medication is applied to the groin area, do not use tight-fitting plastic pants/diapers/garments for incontinence (loss of control of your bladder or bowels). Doing so may increase the absorption of this product through the skin and increase the risk for side effects.
Do not use large amounts of this medication, apply it more often, or use it for a longer time than directed. Your condition may not improve faster, and the risk for side effects may be increased.
Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day.
Tell your doctor if your condition does not improve or if it worsens after 1 week.
",,"Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of:
+
+- other products for the skin (e.g., corticosteroids/antiseptics)
+- aminoglycoside antibiotics (e.g., gentamicin, tobramycin)
+- corticosteroids taken by mouth (e.g., prednisone)
+
+This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
","Tuberculous, viral lesions of the skin (e.g. herpes simplex and varicella); fungal lesions not susceptible to nystatin, facial rosacea, acne vulgaris or perioral dermatitis. Not to be applied to the external auditory canal in patients with perforated tympanic membranes. Do not use on extensive areas to reduce risk of systemic absorption and neomycin-induced ototoxicity. Not recommended for <1 yr.
","Prolonged use may cause sensitivity reactions, impaired wound healing, thinning of skin, striae, telangiectasia, hirsutism, hypothalamic-pituitary-adrenal axis suppression, Cushing's syndrome.
","Pregnancy Category- Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
","Patients with established hearing loss. Avoid occlusive dressing and prolonged or recurrent use. Avoid contact with eyes or mucous membranes. If there is no clinical improvement after 7 days, discontinue use as the infection may be masked by the steroid. Limit use to 5 days if used on the face or on children <1 yr. Use with caution and sparingly on inflamed or damaged skin (e.g extensive burns, trophic ulceration). Pregnancy.
",,,,,"Store at room temperature between 15 and 30 degrees C, away from heat. Check the expiration date on the tube and discard any expired medication.
",10
+1102,Tretinoin (Topical),tretinoin-topical-1102,https://medex.com.bd/attachments/TmcKQplYYMMNS0fdpRs4H35kxCxa6n/tretinoin-topical-prescribing-information,Topical retinoid and related preparations,Scaly skin disease,"For topical application in the treatment of acne vulgaris in which comedones, papules and pustules predominate.
","Topical retinoid and related preparations
","Although the exact mode of action of Tretinoin is unknown, current evidence suggests that topical Tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally Tretinoin stimulates mitotic activity and increases turnover of follicular epithelial cells, causing extrusion of the comedones, papules and pustules.
","This cream should be applied sparingly to the whole affected area once or twice daily. The skin should be thoroughly cleaned and dried before application. Patient should be advised that 6 to 8 weeks of treatment may be required before a therapeutic effect is observed. Moisturizers and cosmetics may be used during treatment with Tretinoin cream but should not be applied to the skin at the same time. Astringent toiletries should be avoided.
",,"Other topical acne treatments should be used with caution during treatment with Tretinoin. Particular caution should be exercised when using preparation containing a peeling agent for example benzoyl peroxide. It is also possible to apply Tretinoin and benzoyl peroxide alternately. The suggested regimens are either Tretinoin in the morning and benzoyl peroxide in the evening or the preparations should be used on alternate days.
","Tretinoin is contraindicated to those who are highly sensitive to any of the ingredients. This cream should not be used in patients with a personal or family history of cutaneous epithelioma (skin cancer).
","Initial external application of Tretinoin generally may cause burning or slight irritation, erythema and peeling at the site of application may also occur. If irritation becomes severe and persists, discontinue application and consult your physicians, if necessary.
","There is an inadequate evidence of the safety of topically applied Tretinoin in human pregnancy. Tretinoin has been associated with teratogenicity in human when administered systemically. So the cream should not be used during pregnancy and lactation.
","Avoid contact of Tretinoin with lips, mouth, eyes, eyelids, nostrils or another mucous membrane. If contact in these areas occurs, careful washing with water is recommended. Apply the cream to sensitive areas of skin, such as the neck, with caution. Do not use it on broken, eczematous or sun burned skin.
",,,,,"Keep out of the reach of children. Keep in a cool & dry place, protect from light.
",10
+1796,Tretinoin (Oral),tretinoin-oral-1796,https://medex.com.bd/attachments/z0wRsFploaX2rmuRjhitVno73yGsBC/tretinoin-oral-prescribing-information,Oral Retinoid preparations,Leukemia,"Tretinoin capsules are indicated for the induction of remission in patients with acute promyelocytic leukemia (APL), French-American-British (FAB) classification M3 (including the M3 variant), characterized by the presence of the t(15;17) translocation and/or the presence of the PML/RARα gene ... Read more
Tretinoin capsules are indicated for the induction of remission in patients with acute promyelocytic leukemia (APL), French-American-British (FAB) classification M3 (including the M3 variant), characterized by the presence of the t(15;17) translocation and/or the presence of the PML/RARα gene who are refractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline-based chemotherapy is contraindicated. Tretinoin is for the induction of remission only. The optimal consolidation or maintenance regimens have not been defined, but all patients should receive an accepted form of remission consolidation and/or maintenance therapy for APL after completion of induction therapy with Tretinoin.
","Oral Retinoid preparations
","Tretinoin is not a cytolytic agent but instead induces cytodifferentiation and decreased proliferation of APL cells in culture and in vivo. In APL patients, tretinoin treatment produces an initial maturation of the primitive promyelocytes derived from the leukemic clone, followed by a repopulation of the bone marrow and peripheral blood by normal, polyclonal hematopoietic cells in patients achieving complete remission (CR). The exact mechanism of action of tretinoin in APL is unknown.
","The recommended dose is 45 mg/m2/day administered as two evenly divided doses until complete remission is documented. Therapy should be discontinued 30 days after achievement of complete remission or after 90 days of treatment, whichever occurs first. If after initiation of treatment of Tretinoin the presence of the t(15;17) translocation is not confirmed by cytogenetics and/or by polymerase chain reaction studies and the patient has not responded to Tretinoin, alternative therapy appropriate for acute myelogenous leukemia should be considered. Tretinoin is for the induction of remission only. Optimal consolidation or maintenance regimens have not been determined. All patients should, therefore, receive a standard consolidation and/or maintenance chemotherapy regimen for APL after induction therapy with Tretinoin, unless otherwise contraindicated.
",,"As Tretinoin is metabolized by the hepatic P450 system, there is a potential for alteration of pharmacokinetics parameters in patients administered concomitant medications that are also inducers or inhibitors of this system. Medications that generally induce hepatic P450 enzymes include rifampicin, glucocorticoids, phenobarbital and pentobarbital. Medications that generally inhibit hepatic P450 enzymes include ketoconazole, cimetidine, erythromycin, verapamil, diltiazem and cyclosporine. To date there are no data to suggest that co-use with these medications increases or decreases either efficacy or toxicity of Tretinoin.
","Tretinoin is contraindicated in patients with a known hypersensitivity to Tretinoin, any of its components, or other retinoids. Tretinoin should not be given to patients who are sensitive to parabens, which are used as preservatives in the gelatin capsule.
","Virtually all patients experience some drug-related toxicity, especially headache, fever, weakness, and fatigue. These adverse effects are seldom permanent or irreversible nor do they usually require interruption of therapy. Some of the adverse events are common in patients with APL, including hemorrhage, infections, gastrointestinal hemorrhage, disseminated intravascular coagulation, pneumonia, septicemia, and cerebral hemorrhage. The following describes the adverse events, regardless of drug relationship, that were observed in patients treated with Tretinoin.
","Pregnancy Category D. Tretinoin has teratogenic and embryotoxic effects in mice, rats, hamsters, rabbits and pigtail monkeys, and may be expected to cause fetal harm when administered to a pregnant woman. Tretinoin causes fetal resorptions and a decrease in live fetuses in all animals studied. Although experience with humans administered Tretinoin is extremely limited, increased spontaneous abortions and major human fetal abnormalities related to the use of other retinoids have been documented in humans.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions from Tretinoin in nursing infants, mothers should discontinue nursing prior to taking this drug.
","Tretinoin has potentially significant toxic side effects in APL patients. Patients undergoing therapy should be closely observed for signs of respiratory compromise and/or leukocytosis. Supportive care appropriate for APL patients, eg, prophylaxis for bleeding, prompt therapy for infection, should be maintained during therapy with Tretinoin.
There is a risk of thrombosis (both venous and arterial) which may involve any organ system, during the first month of treatment. Therefore, caution should be exercised when treating patients with the combination of Tretinoin and anti-fibrinolytic agents, such as tranexamic acid, aminocaproic acid or aprotinin.
The ability to drive or operate machinery might be impaired in patients treated with Tretinoin, particularly if they are experiencing dizziness or severe headache. Microdosed progesterone preparations (""minipill"") may be an inadequate method of contraception during treatment with Tretinoin.
","Pediatric Use: There are limited clinical data on the pediatric use of Tretinoin. Of 15 pediatric patients (age range: 1 to 16 years) treated with Tretinoin, the incidence of complete remission was 67%. Safety and effectiveness in pediatric patients below the age of 1 year have not been established. Some pediatric patients experience severe headache and pseudotumor cerebri, requiring analgesic treatment and lumbar puncture for relief. Increased caution is recommended in the treatment of pediatric patients. Dose reduction may be considered for pediatric patients experiencing serious and/or intolerable toxicity; however, the efficacy and safety of Tretinoin at doses lower than 45 mg/m2 /day have not been evaluated in the pediatric population.
Geriatric Use: Of the total number of subjects in clinical studies of Tretinoin, 21.4% were 60 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
","There has been no experience with acute overdosage in humans. The maximal tolerated dose in patients with myelodysplastic syndrome or solid tumors was 195 mg/m2 /day. The maximal tolerated dose in pediatric patients was lower at 60 mg/m2 /day. Overdosage with other retinoids has been associated with transient headache, facial flushing, cheilosis, abdominal pain, dizziness and ataxia. These symptoms have quickly resolved without apparent residual effects. There is no specific treatment in the case of an overdose, however, it is important that the patient be treated in a special hematological unit.
",,,"Store at 15° to 30°C. Protect from light.
",12
+1484,Trelagliptin Succinate,trelagliptin-succinate-1484,,Dipeptidyl Peptidase-4 (DPP-4) inhibitor,Type 2 DM,"Trelagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is a highly selective dipeptidyl peptidase-4 inhibitor that is typically used as an add on treatment when the first line treatment of metformin is not achieving the ... Read more
Trelagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is a highly selective dipeptidyl peptidase-4 inhibitor that is typically used as an add on treatment when the first line treatment of metformin is not achieving the expected glycemic goals; though it has been approved for use as a first line treatment when metformin cannot be used.
","Dipeptidyl Peptidase-4 (DPP-4) inhibitor
","It controls blood glucose levels by selectively and continually inhibiting DPP-4, an enzyme that causes the inactivation of glucagon-like peptide-1 and glucagon-dependent insulinotropic polypeptide, incretin hormones that play an important role in blood glucose regulation. The inhibition of DPP-4 increases insulin secretion depending on blood glucose concentration, thereby controlling blood glucose levels. It is indicated for the treatment of type 2 diabetes.
","100 mg of Trelagliptin is administered to adults once weekly by mouth. This has lesser hypoglycemic events and 4 and 12-fold more potent than Alogliptin and Sitagliptin.
",,,"Study subjects meeting any of the following criteria will not be included in this study:
+
+- Patients under treatment with trelagliptin for type 2 diabetes at the start of screening.
+- Patients with a diagnosis of type 1 diabetes.
+- Patients with severe renal impairment or renal failure (e.g., eGFR < 30 mL/min/1.73 m2 or on dialysis).
+- Patients with serious heart disease or a cerebrovascular disorder, or a serious pancreatic, blood, or other disease.
+- Patients with a history of gastrointestinal resection.
+- Patients with a proliferative diabetic retinopathy.
+- Patients with malignancy.
+- Patients with a history of hypersensitivity or allergy to DPP-4 inhibitors.
+- Patients who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant.
+- Patients who may need to add or discontinue concomitant medication or change the dose during the study period.
+- Patients who will require treatment with a prohibited concomitant medication during the study period.
+- Patients participating in other clinical studies.
+- Patients assessed as ineligible for any other reason by the investigators.
+
","Among 901 domestic clinical trial cases up to the time of approval, 103 cases ( 11.4%) showed clinical results that included abnormalities and side effects. These mainly included hypoglycemia, nasopharyngitis, and elevated lipase.
Given the appearance of serious side effects such as hypoglycemia (0.1~5%) , administer medication in conjunction with close observation of patient status. Other DPP-4 inhibitors have been reported to present serious hypoglycemia in combination with Sulfonylurea medications as well as some cases of loss of consciousness. Moreover, decreased blood sugar from the use of this medication, once confirmed, can be remedied by giving sucrose. However, hypoglycemia resulting from a combination with glucosidase inhibitors should be treated with fructose.
","No study has performed in patients who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant.
","(provide cautious dosage to the following patients): The following patients or circumstances
+
+- Patients with moderate kidney function disorder
+- Patients undergoing treatment with sulfonylurea drugs or insulin medication [there are reports of severe hypotension with use in combination with other DPP-4 inhibitors]
+- Hypopituitarism or hypoadrenalism
+- Malnutrition, starvation, irregular eating patterns, insufficient eating, or hyposthenia
+- Vigorous exercise
+- Patients who consume excessive alcohol
+
",,,,,"Store at 25°C; excursions permitted to 15°-30°C. Dispense medication in the original container to protect from exposure to high humidity and light. Keep out of the reach of children
",9
+1072,Travoprost + Timolol Maleate,travoprost-timolol-maleate-1072,https://medex.com.bd/attachments/nHdlR10H70iamnqWwhJt0jiKeBhEMi/travoprost-timolol-maleate-prescribing-information,Drugs for miotics and glaucoma,Open angle glaucoma,"This Sterile Ophthalmic Solution is indicated for the treatment of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to single therapy with prostaglandin analogue or topical beta blocker.
","Drugs for miotics and glaucoma
","Travoprost and Timolol reduce intraocular pressure (IOP) by complementary mechanisms of action. Travoprost is a prostaglandin analogue which reduces IOP by increasing trabecular outflow & uveoscleral outflow. Timolol is a non-selective beta adrenergic receptor blocker that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic (membrane stabilizing) activity. It lowers IOP by decreasing the formation of aqueous humor in the ciliary epithelium.
","Instill one drop in the conjunctival sac of the affected eye(s) once daily at about the same time each day, preferably in the evening.
",,,"Contraindicated in patients who are hypersensitive to Travoprost, Timolol or any of the components of this preparation.
","No serious adverse reactions are reported. Most frequently reported side effects are ocular hyperemia.
","Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. It should not be used during pregnancy.
Use in lactation: Caution should be exercised when Travoprost + Timolol Maleate is administered to a nursing mother.
","For ophthalmic use only. Patients should remove their contact lenses prior to instilling this preparation and should not insert their lenses until 15 minutes after instillation of the preparation.
","Use in children: Safety and effectiveness in pediatric patients have not been established.
Use in elderly patients: No overall differences in safety and effectiveness have been observed between elderly and other adult patients.
",,,,"Store in a cool, dry place, away from heat and direct light. Keep out of the reach of children. Do not use more than 4 weeks after opening the bottle
",10
+1101,Travoprost,travoprost-1101,https://medex.com.bd/attachments/XTVJvMKU7OyY5JOql9qJh5cTcXiDW9/travoprost-prescribing-information,Drugs for miotics and glaucoma,Open angle glaucoma,"Travoprost Eye Drops is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are intolerant of or insufficiently responsive to another intraocular pressure lowering medication, as monotherapy or as adjunctive therapy.
","Drugs for miotics and glaucoma
","Travoprost, an isopropyl ester prodrug, is a synthetic prostaglandin F2 alpha analogue that is rapidly hydrolyzed by esterases in the cornea to its biologically active free acid. The travoporst free acid is potent and highly selective for the FP prostanoid receptor.
Travoprost free acid is a selective FP prostanoid receptor agonist and is believed to reduce intraocular pressure by increasing the drainage of aqueous humor, which is done primarily through increased uveoscleral outflow and to a lesser extent, trabecular outflow facility.
","Use in adults: The recommended dose is one drops of Travoprost in the conjunctival sac of the affected eye (s) once daily in the evening, If more than one topical ophthalmic product is being used, the medicines must be administered at least 5 minutes apart. When substituting another ophthalmic antiglaucoma agent with Travoprost, discontinue the other agent and start the following day with Travoprost.
Pediatric patients: The efficacy and safety of travoprost eye drops in patients below the age of 18 years have not been established.
",,"Reduced therapeutic effect with NSAIDs.
","Travoprost eye drops is contraindicated in patients with hypersensitive to travoprost or any excipients of this preparation.
","The most frequently reported treatment-related side-effect is ocular hyperaemia.
","There are no adequate and well-controlled clinical study En pregnant women. Travoprost should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether the drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when travoprost is administered to a lactating woman.
","Travoprost should be used with caution in patients with active intraocular inflammation (iritis/uveitis). Travoprost should not be administered while wearing contact lenses. Contact lenses should be removed prior to the administration of the solution. Lenses may be reinserted 15 minutes following administration of Travoprost.
",,,,,"Store in a cool, dry place and protected from light. Keep out of reach of children. Discard the container 4 weeks after opening.
",10
+1427,Trastuzumab Emtansine,trastuzumab-emtansine-1427,,Anti neoplastic preparations,Metastatic breast carcinoma,"Metastatic Breast Cancer (MBC): Trastuzumab Emtansine, as a single agent, is indicated for the treatment of patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with trastuzumab and a taxane.
","Anti neoplastic preparations
","Trastuzumab Emtansine is a HER2-targeted antibody-drug conjugate which contains the humanized anti-HER2 IgG1, trastuzumab, covalently linked to the microtubule inhibitory drug DM1 (a maytansine derivative) via the stable thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate). Emtansine refers to the MCC-DM1 complex. An average of 3.5 DM1 molecules are conjugated to each molecule of trastuzumab.
Conjugation of DM1 to trastuzumab confers selectivity of the cytotoxic agent for HER2-overexpressing tumor cells, thereby increasing intracellular delivery of DM1 directly to malignant cells. Upon binding to HER2, trastuzumab emtansine undergoes receptor-mediated internalization and subsequent lysosomal degradation, resulting in release of DM1-containing cytotoxic catabolites (primarily lysine-MCC-DM1).
Trastuzumab Emtansine has the mechanisms of action of both trastuzumab and DM1.
Trastuzumab emtansine, like trastuzumab, binds to domain IV of the HER2 extracellular domain (ECD), as well as to Fcγ receptors and complement C1q. In addition, Trastuzumab Emtansine, like trastuzumab, inhibits shedding of the HER2 ECD, inhibits signaling through the phosphatidylinositol 3-kinase (PI3-K) pathway, and mediates antibody-dependent cell-mediated cytotoxicity (ADCC) in human breast cancer cells that overexpress HER2.
DM1, the cytotoxic drug component of Trastuzumab Emtansine, binds to tubulin. By inhibiting tubulin polymerization, both DM1 and Trastuzumab Emtansine cause cells to arrest in the G2/M phase of the cell cycle, ultimately leading to apoptotic cell death. Results from in vitro cytotoxicity assays show that DM1 is 20–200 times more potent than taxanes and vinca alkaloids.
The MCC linker is designed to limit systemic release and increase targeted delivery of DM1, as demonstrated by detection of very low levels of free DM1 in plasma.
","Recommended Doses And Schedules: The recommended dose of Trastuzumab Emtansine is 3.6 mg/kg given as an intravenous infusion every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. Do not administer Trastuzumab Emtansine at doses greater than 3.6 mg/kg. Do not substitute Trastuzumab Emtansine for or with trastuzumab. Closely monitor the infusion site for possible subcutaneous infiltration during drug administration
First Infusion: Administer infusion over 90 minutes. Patients should be observed during the infusion and for at least 90 minutes following the initial dose for fever, chills, or other infusionrelated reactions
Subsequent Infusions: Administer over 30 minutes if prior infusions were well tolerated. Patients should be observed during the infusion and for at least 30 minutes after infusion.
",,"No formal drug-drug interaction studies with trastuzumab emtansine in humans have been conducted. In vitro metabolism studies in human liver microsomes suggest that DM1, a component of trastuzumab emtansine, is metabolized mainly by CYP3A4 and, to a lesser extent, by CYP3A5. DM1 does not induce or inhibit P450-mediated metabolism in vitro. Caution should be taken when trastuzumab emtansine is co-administered with potent CYP3A inhibitors.
","Trastuzumab Emtansine is contraindicated in patients with a known hypersensitivity to Trastuzumab Emtansine or any of its excipients
",,"Pregnancy: There are no clinical studies of trastuzumab emtansine in pregnant women. No reproductive and developmental toxicology studies have been conducted with trastuzumab emtansine.
Trastuzumab, a component of trastuzumab emtansine, can cause fetal harm or death when administered to a pregnant woman. In the postmarketing setting, cases of oligohydramnios, some associated with fatal pulmonary hypoplasia, have been reported in pregnant women receiving trastuzumab. Animal studies of maytansine, a closely related chemical entity of the same maytansinoid class as DM1, suggest that DM1, the microtubule inhibiting cytotoxic drug component of trastuzumab emtansine, is expected to be teratogenic and potentially embryotoxic.
Administration of trastuzumab emtansine to pregnant women is not recommended. Women who become pregnant must contact their doctor and should be advised of the possibility of harm to the fetus. If a pregnant woman is treated with trastuzumab emtansine, close monitoring by a multidisciplinary team is recommended.
Nursing Mothers: It is not known whether trastuzumab emtansine is excreted in human milk. Since many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Kadcyla, women should discontinue nursing prior to initiating treatment with trastuzumab emtansine. Women may begin nursing 7 months after concluding treatment.
","Patients treated with Trastuzumab Emtansine must have confirmed HER2-positive tumor status as assessed by either HER2 protein overexpression or gene amplification.
","Pediatric Use: The safety and efficacy of Trastuzumab Emtansine in children below 18 years of age have not been established.
Geriatric Use: There are insufficient data to establish the safety and efficacy of Trastuzumab Emtansine in patients 75 years of age or older.
",,,,"Store vials at 2°C-8°C.
",10
+1118,Vancomycin Hydrochloride,vancomycin-hydrochloride-1118,https://medex.com.bd/attachments/uLyYunIdsZXNKv3WNT5grjiWPXLdYV/vancomycin-hydrochloride-prescribing-information,,Infections,"Vancomycin is indicated in potentially life-threatening infections which cannot be treated with other effective, less toxic antimicrobial drugs including the penicillins and cephalosporins.
Vancomycin is useful in the therapy of severe staphylococcal infections in patients who cannot receive ... Read more
Vancomycin is indicated in potentially life-threatening infections which cannot be treated with other effective, less toxic antimicrobial drugs including the penicillins and cephalosporins.
Vancomycin is useful in the therapy of severe staphylococcal infections in patients who cannot receive or who have failed to respond to the penicillins and cephalosporins or who have infections with staphylococci, resistant to other antibiotics.
Vancomycin is used in the treatment of endocarditis and as prophylaxis against endocarditis in patients undergoing dental or surgical procedures.
Its effectiveness has been documented in other infections due to staphylococci including osteomyelitis, pneumonia, septicemia and soft tissue infections.
","Other antibiotic
","Vancomycin binds tightly to D-alanyl-D-alanine portion cell wall precursor causing blockage of glycopeptide polymerisation which produces immediate inhibition of cell wall synthesis and secondary damage to the cytoplasmic membrane.
","Concentrations of no more than 5 mg/ml and rates of no more than 10 mg/min are recommended in adults. In selected patients in need of fluid restriction, a concentration up to 10 mg/ml may be used.
Patients with Normal Renal Function:
+
+- Adults: Usual daily dose is 2 gm (in 4 or 2 divided doses).
+- Children: Total daily dose is 40 mg/Kg (in 4 divided doses).
+- Infants and Neonates: An initial dose of 15 mg/Kg is suggested followed by 10 mg/Kg every 12 hours in the first week, then every 8 hours up to 1 month.
+
+
Patients with Impaired Renal Function and Elderly Patients: Dosage adjustment must be made in patients with impaired renal function. In premature infants and the elderly, dosage reduction may be necessary to a greater extent than expected because of decreasing renal function. If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following chart-
+
+- CrCl 100 ml/min: Vancomycin Dose 1545 mg/24 h
+- CrCl 90 ml/min: Vancomycin Dose 1390 mg/24 h
+- CrCl 80 ml/min: Vancomycin Dose 1235 mg/24 h
+- CrCl 70 ml/min: Vancomycin Dose 1080 mg/24 h
+- CrCl 60 ml/min: Vancomycin Dose 925 mg/24 h
+- CrCl 50 ml/min: Vancomycin Dose 770 mg/24 h
+- CrCl 40 ml/min: Vancomycin Dose 620 mg/24 h
+- CrCl 30 ml/min: Vancomycin Dose 465 mg/24 h
+- CrCl 20 ml/min: Vancomycin Dose 310 mg/24 h
+- CrCl 10 ml/min: Vancomycin Dose 155 mg/24 h
+
+The initial dose should be not less than 15 mg/kg even in patients with mild to moderate renal insufficiency. Above chart is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given in order to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 h. Since individual maintenance doses of 250-1,000 mg are convenient, 1 dose may be given every several days rather than on a daily basis in patients with marked renal impairment. In anuria, a dose of 1000 mg every 7-10 days has been recommended. Intermittent infusion is the recommended method of administration. Intraperitoneal administration is not recommended.
",,,"Vancomycin is contraindicated in Patients with known hypersensitivity to Vancomycin
","Vancomycin is well tolerated. However during or soon after rapid infusion of Vancomycin, patients may develop anaphylactic reactions including hypotension, wheezing, dyspnoea, urticaria or pruritus. Rapid infusion may also cause flushing of the upper body (""red neck"") or pain and muscle spasm of the chest and back. These reactions usually resolve within 20 minutes but may persist for several hours. Such events are infrequent if Vancomycin is given by a slow infusion over 60 minutes.
","It is not known whether it causes foetal harm or not. Vancomycin should be given in pregnancy only if clearly needed and blood levels should be monitored carefully to minimise the risk of foetal toxicity.
Vancomycin Hydrochloride is excreted in human milk. Caution should be exercised when Vancomycin is administered to a nursing woman. It is unlikely that a nursing infant can absorb a significant amount of Vancomycin from its gastro-intestinal tract
","Patients with borderline renal function and individuals over the age of 60 should be given serial tests of auditory function and of Vancomycin blood levels. All patients receiving the drug should have periodic haematological studies, urine analysis and renal function tests.
Vancomycin is very irritating to tissue and causes injection site necrosis when injected intramuscularly. It must be infused intravenously. Injection site pain and thrombophlebitis occur in many patients receiving Vancomycin and are occasionally severe.
Prolonged use of Vancomycin may result in the overgrowth of non-susceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. In rare instances, there have been reports of pseudomembranous colitis due to C. difficile, developing in patients who received intravenous Vancomycin.
",,"Supportive care is advised with maintenance of glomerular filtration. Vancomycin is poorly removed from the blood by haemodialysis or peritoneal dialysis. Haemoperfusion with Amberlite resin XAD-4 has been reported to be of limited benefit
",,,"Store in a cool and dry place, protected from light. Keep out of reach of children.
",10
+574,Valsartan + Hydrochlorothiazide,valsartan-hydrochlorothiazide-574,https://medex.com.bd/attachments/vekMtePGHiMKXwkvrcOEu5uG8OTU8l/valsartan-hydrochlorothiazide-prescribing-information,Combined antihypertensive preparations,Hypertension,"This combination is indicated for the treatment of hypertension.
","Combined antihypertensive preparations
","Valsartan is an oral medication that belongs to a class of drugs called angiotensin receptor blockers (ARBs). It is orally active and specific angiotensin II antagonist acting on the AT1 subtype. Angiotensin's attachment to the receptors cause the blood vessels to narrow (vasoconstrict) which leads to an increase in blood pressure (hypertension). Valsartan blocks the angiotensin II receptor. By blocking the action of angiotensin, Valsartan dilates blood vessels and reduces blood pressure without affecting pulse rate. Valsartan has much greater affinity (about 20,000-fold) for the AT1 receptor than for the AT2 receptor. It does not bind or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so co-administration of anangiotensin converting enzyme (ACE) inhibitor tends to reverse the potassium loss associated with these diuretics.
","Hypertension: A patient whose blood pressure is not controlled with Valsartan and Hydrochlorothiazide monotherapy, should switch to Valsartan and Hydrochlorothiazide combination once daily. Highest allowed dose of Valsartan should not be greater than 320 mg in combination with hydrochlorothiazide 25 mg.
For Elderly: No initial dosage adjustment is necessary for elderly patients.
Pediatric use: Safety and effectiveness in pediatric patients have not been established.
",,"Valsartan:
+
+- Diuretics: Patient on diuretics may occasionally experience excessive reduction in blood pressure after initiation of therapy with Valsartan. No drug interaction of clinical significance has been identified with thiazide diuretics.
+- Agents increasing Serum Potassium: Since Valsartan decreases the production of aldosterone, potassium supplements or salt containing potassium substitutes may lead to hyperkalemia.
+- Lithium Salts: As with other drugs which eliminate sodium, lithium clearance may be reduced. Therefore, serum lithium levels should be monitored carefully if lithium salts are to be administered.
+- Other drugs showing interaction are Warfarin, Digoxin.
+
+Hydrochlorothiazide:
+
+- When administered concurrently, the following drugs may interact with thiazide diuretics: alcohol, barbiturates, or narcotics may potentiate antihypertensive effect or orthostatic hypotension may occur.
+- Antidiabetic drugs (oral agents and insulin): dosage adjustment of the antidiabetic drug may be required.
+- Other antihypertensive drugs give additive effect.
+- Cholestyramine and colestipol resins: absorption of Hydrochlorothiazide is impaired in the presence of anionic exchange resins.
+
","The combination of Valsartan and Hydrochlorothiazide is contraindicated in patients who are hypersensitive to any component of this product. Because of the Hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
","The combination of Valsartan and Hydrochlorothiazide is generally well tolerated and side effects are rare. The most common side effects include headache, dizziness, fatigue, abdominal pain, cough, diarrhea and nausea. Patient may also experience hyperkalemia, impotency, reduced renal function, allergic reactions, dyspnea, constipation, back pain, muscle cramps, rash, anxiety, insomnia and vertigo. Hypotension may also occur.
","Pregnancy: Valsartan should not be used in pregnancy, as in 2nd and 3rd trimester it can cause injury and even death to fetus. When pregnancy is detected, Valsartan should be stopped as soon as possible.
Nursing mothers: It is not known whether Valsartan is excreted in human milk. Hydrochlorothiazide is excreted in breast milk.
","Impaired Hepatic Function: As the majority of Valsartan is eliminated in the bile, care should be exercised in patients with mild to moderate hepatic impairment including biliary obstructive disorder.
Impaired Renal Function: Dosage reduction or discontinuation may be required with patients having pre-existing renal impairment because thiazides may precipitate azotemia.
Heart Failure and Myocardial Infarction: Caution should be observed when initiating therapy in patients with heart failure and post-myocardial infarction patients.
","Use in Patients with Renal Impairment: The usual regimens of therapy with this combination may be followed as long as the patient's creatinine clearance is >30 ml/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. In that case, hydrochlorothiazide is not recommended.
Use in patients with Hepatic Impairment: Care should be taken in patient with hepatic impairment.
","Valsartan: Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If excessive hypotension occurs, the patient should be placed in the supine position and if necessary, has to be given an intravenous infusion of normal saline.
Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration) resulting from excessive diuresis. if digitalis has also been administered with it, hypokalemia, may accentuate cardiac arrhythmias. The degree to which Hydrochlorothiazide is removed by hemodialysis has not been established.
",,,"Store between 15-30° C.
",12
+1117,Valsartan,valsartan-1117,https://medex.com.bd/attachments/cYsqKLUearRrASYwqik7jJfjjjy7Fm/valsartan-prescribing-information,Angiotensin-ll receptor blocker,Post myocardial infarction,"Valsartan is indicated:
+
+- For hypertension
+- To reduce hospitalizations in patients with congestive heart failure
+- To reduce death in patients who developed congestive heart failure after myocardial infarction
+
","Angiotensin-ll receptor blocker
","Valsartan is an oral medication that belongs to a class of drugs called angiotensin receptor blockers (ARBs). It is orally active and specific angiotensin II antagonist acting on the AT1 subtype. Angiotensin's attachment to the receptors cause the blood vessels to narrow (vasoconstrict) which leads to an increase in blood pressure (hypertension). Valsartan blocks the angiotensin II receptor. By blocking the action of angiotensin, Valsartan dilates blood vessels and reduces blood pressure without affecting pulse rate. Valsartan has much greater affinity (about 20,000-fold) for the AT1 receptor than for the AT2 receptor. It does not bind or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
","Hypertension: The usual dose of Valsartan is 80 to 160 mg once daily. The maximum dose is 320 mg daily. Maximum blood pressure reduction occurs within 4 weeks.
Heart failure: The usual dose is 40 mg twice daily and may be increased to 80-160 mg twice daily.
Post-Myocardial Infarction: The initial dose after myocardial infarction is 20 mg twice daily. The dose should be increased with a target of 160 mg daily if tolerated without side effects.
","Administration of Valsartan with food decreases the absorption of Valsartan by about 40%, so it should be taken on an empty stomach. No initial dosage adjustment is required for elderly patients with mild to moderate renal and hepatic insufficiency.
","No drug interactions of clinical significance have been found. Compounds which have been studied in clinical trials include Cimetidine, Warfarin, Furosemide, Digoxin, Atenolol, Indomethacin, Hydrochlorothiazide, Amlodipine and Glibenclamide
As Valsartan is not metabolized to a significant extent, clinically relevant drug-drug interactions in the form of metabolic induction or inhibition of the cytochrome P450 system are not expected with Valsartan. Although valsartan is highly bound to plasma proteins, in vitrostudies have not shown any interaction at this level with a range of molecules which are also highly protein bound, such as Diclofenac, Furosemide, and Warfarin. Concomitant use of potassium sparing diuretics (e.g., Spironolactone, Triamterene, Amiloride) potassium supplements, or salt substitutes containing potassium may lead to increase in serum potassium. If co medication is considered necessary, caution is advisable
","Valsartan is contraindicated in patients who are hypersensitive to any component of this product.
","Valsartan is generally well tolerated and side effects are rare. The most common side effects include headache, dizziness, fatigue, abdominal pain, cough, diarrhea and nausea. Patient may also experience hyperkalemia, impotency, reduced renal function, allergic reactions, dyspnea, constipation, back pain, muscle cramps, rash, anxiety, insomnia and vertigo. Hypotension may also occur if patient have been taking diuretics along with Valsartan.
","Pregnancy: Valsartan should not be used in pregnancy, as in 2nd and 3rd trimester it can cause injury and even death to fetus. When pregnancy is detected, Valsartan should be stopped as soon as possible.
Nursing mothers: It is not known whether Valsartan is excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
","Impaired Hepatic Function: As the majority of Valsartan is eliminated in the bile, care should be exercised in patients with mild to moderate hepatic impairment including biliary obstructive disorder.
Impaired Renal Function: Dosage reduction or discontinuation may be required with patients having pre-existing renal impairment.
Heart Failure and Myocardial Infarction: Caution should be exercised when initiating therapy in patients with heart failure and post-myocardial infarction patients.
","Pediatric use: Safety and effectiveness in paediatric patients have not been established.
Geriatric use: No overall difference in the efficacy or safety of Valsartan was observed in this patient population, but greater sensitivity of some elderly persons cannot be ruled out.
Hepatic Impairment:
+
+- Mild to moderate: Max: 80 mg once daily.
+- Severe: Contraindicated.
+
","Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia, bradycardia could occur from parasympathetic (vagal) stimulation. If excessive hypotension occurs, the patient should be placed in the supine position and if necessary, has to be given an intravenous infusion of normal saline.
",,,"Store between 15-30° C. Protect from moisture and heat.
",13
+1425,Valganciclovir,valganciclovir-1425,,Anti-viral drugs,Cytomegalovirus (CMV) retinitis,"Valganciclovir is indicated for the treatment of cytomegalovirus (CMV) retinitis in adult patients with acquired immunodeficiency syndrome (AIDS). Valganciclovir is indicated for the prevention of CMV disease in adult and pediatric solid organ transplant (SOT) patients who are at risk.
","Anti-viral drugs
","Valganciclovir is an L-valyl ester (prodrug) of ganciclovir, which after oral administration is rapidly converted to ganciclovir by intestinal and hepatic esterases. Ganciclovir is a synthetic analogue of 2’-deoxyguanosine, which inhibits replication of herpes viruses in vitro and in vivo. Sensitive human viruses include human cytomegalovirus (HCMV), herpes simplex virus-1 and -2 (HSV-1 and HSV-2), human herpes virus 6, 7 and 8 (HHV-6, HHV-7, HHV-8), Epstein-Barr virus (EBV), varicella-zoster virus (VZV) and hepatitis B virus.
In CMV-infected cells ganciclovir is initially phosphorylated to ganciclovir mono-phosphate by the viral protein kinase, UL97. Further phosphorylation occurs by cellular kinases to produce ganciclovir triphosphate, which is then slowly metabolized intracellularly. This has been shown to occur in HSV- and HCMV-infected cells with half-lives of 18 and between 6 and 24 hours respectively after removal of extracellular ganciclovir. As phosphorylation is largely dependent on the viral kinase, the phosphorylation of ganciclovir occurs preferentially in virus-infected cells.
The virustatic activity of ganciclovir is due to inhibition of viral DNA synthesis by: (a) competitive inhibition of incorporation of deoxyguanosine-triphosphate into DNA by viral DNA polymerase and (b) incorporation of ganciclovir triphosphate into viral DNA causing termination of, or very limited further viral DNA elongation. Typical antiviral IC 50 against CMV in vitro is in the range 0.08 μM (0.02 μg/ml) to 14 μM (3.5 μg/ml).
The clinical antiviral effect of Valganciclovir has been demonstrated in the treatment of AIDS patients with newly diagnosed CMV retinitis (clinical trial WV15376). CMV shedding was decreased from 46% (32/69) of patients at study entry to 7% (4/55) of patients following 4 weeks of Valganciclovir treatment.
","Standard Dosage: Valganciclovir is administered orally, and should be taken with food. Valganciclovir is rapidly and extensively converted into the active ingredient ganciclovir. The bioavailability of ganciclovir from Valganciclovir is up to 10-fold higher than from oral ganciclovir.
The dosage and administration of Valganciclovir tablets or powder for oral solution as described below should be closely followed. The ganciclovir systemic exposure following administration of 900 mg Valganciclovir powder for oral solution is equivalent to a 900 mg Valganciclovir dose administered as two 450 mg tablets.
An oral dosing dispenser with 25 mg graduations up to 500 mg is provided with the powder for oral solution. It is recommended that this dispenser is used to measure and administer the dose.
+
Treatment of cytomegalovirus (CMV) retinitis-
+
Adult patients:
+
+- Induction treatment of CMV retinitis: For patients with active CMV retinitis, the recommended dose is 900 mg twice a day for 21 days. Prolonged induction treatment may increase the risk of bone marrow toxicity
+- Maintenance treatment of CMV retinitis: Following induction treatment, or in adult patients with inactive CMV retinitis, the recommended dose is 900 mg once daily. Patients whose retinitis worsens may repeat induction treatment. The duration of maintenance treatment should be determined on an individual basis.
+
+
Pediatric patients: The safety and efficacy of Valganciclovir in the treatment of CMV retinitis have not been established in adequate and well-controlled clinical studies in pediatric patients.
+
Prevention of CMV disease in transplantation-
+
Adult patients: For kidney transplant patients, the recommended dose is 900 mg once daily starting within 10 days post-transplantation and continuing until 200 days post-transplantation. For patients who have received a solid organ transplant other than kidney, the recommended dose is 900 mg once daily starting within 10 days post-transplantation and continuing until 100 days post-transplantation.
Pediatric patients: In pediatric solid organ transplant patients from birth, who are at risk of developing CMV disease, the recommended once daily dose of Valganciclovir is based on body surface area (BSA) and creatinine clearance (ClCr) derived from Schwartz formula (ClCr), and is calculated using the equation below:
Pediatric dose (mg)= 7 x BSA x ClCr. If the creatinine clearance exceeds 150 ml/min/1.73 m
2, then a maximum value of 150 ml/min/1.73 m
2 ",,"In vivo drug-drug interaction studies were not conducted with valganciclovir. However, because valganciclovir is rapidly and extensively converted to ganciclovir, drug-drug interactions associated with ganciclovir will be expected for Valganciclovir. Drug-drug interaction studies with ganciclovir were conducted in patients with normal renal function. Following concomitant administration of Valganciclovir and other renally excreted drugs, patients with impaired renal function may have increased concentrations of ganciclovir and the coadministered drug. Therefore, these patients should be closely monitored for toxicity of ganciclovir and the coadministered drug.
","Valganciclovir is contraindicated in patients with known hypersensitivity to valganciclovir, ganciclovir or to any of the excipients.
","The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
+
+- Hematologic Toxicity
+- Acute Renal Failure
+- Impairment of Fertility
+- Fetal Toxicity
+- Mutagenesis and Carcinogenesis
+
","Pregnancy: The safety of Valganciclovir for use in pregnant women has not been established. However, ganciclovir readily diffuses across the human placenta. The use of Valganciclovir should be avoided in pregnant women unless the benefit to the mother outweighs the potential risk to the fetus. Reprotoxicity studies have not been repeated with valganciclovir because of the rapid and extensive conversion to ganciclovir. In animal studies ganciclovir was associated with reproductive toxicity and teratogenicity (see section 3.3.4 Reproductive Toxicity). The safe use of Valganciclovir during labor and delivery has not been established.
Lactation: Peri- and postnatal development has not been studied with valganciclovir or with ganciclovir but the possibility of ganciclovir being excreted in breast milk and causing serious adverse reactions in the nursing infant cannot be discounted. Human data are not available but animal data indicates that ganciclovir is excreted in the milk of lactating rats. Therefore, a decision should be made to discontinue the drug or discontinue nursing taking into consideration the potential benefit of Valganciclovir to the nursing mother.
",,"Pediatric Use: A higher risk of hematological cytopenias in neonates and infants warrants careful monitoring of blood counts in these age groups. Monitoring of liver function abnormalities, renal function and gastrointestinal fluid loss is also recommended in pediatric patients.
Geriatric Use: Safety and efficacy have not been established in this patient population
Renal Impairment: In patients with impaired renal function, dosage adjustments based on creatinine clearance are required.
Hepatic Impairment: Safety and efficacy have not been established in this patient population
",,,,"Store Valganciclovir tablets at 20°C to 25°C; excursions are permitted to 15°C to 30°C
",10
+1115,Valacyclovir,valacyclovir-1115,https://medex.com.bd/attachments/K5svGfnWtAvpfWcKKDi44ILdrfdmGi/valacyclovir-prescribing-information,Herpes simplex & Varicella-zoster virus infections,Varicella zoster (chickenpox),"Valacyclovir is indicated for the treatment of Herpes zoster (shingles). It is indicated for the treatment or suppression of genital herpes in immuno-competent individuals and for the suppression of recurrent genital herpes in HIV infected individuals. It is also indicated for the treatment of cold sores (Herpes labialis).
","Herpes simplex & Varicella-zoster virus infections
","Valacyclovir is the hydrochloride salt of L-valyl ester of the antiviral drug acyclovir. Valacyclovir is an antiviral drug. It slows the growth and spread of the herpes virus so that the body can fight off the infection. Valacyclovir lessens the symptoms of infections and shortens the length of time of sickness. Valacyclovir is used in the treatment and suppression of genital herpes, shingles and cold sores.
","Adult Dosage:
+
Cold Sores: 2 grams every 12 hours for 1 day
+
Genital Herpes:
+
+- Initial episode: 1 gram twice daily for 10 days
+- Recurrent episodes: 500 mg twice daily for 3 days Suppressive therapy
+- Immunocompetent patients: 1 gram once daily
+- Alternate dose in patients with < 9 recurrences/year: 500 mg once daily
+- HIV-infected patients: 500 mg twice daily
+- Reduction of transmission: 500 mg once daily
+
+
Herpes Zoster: 1 gram 3 times daily for 7 days
+
Pediatric Dosage:
+
+- Cold Sores (> 12 years of age): 2 grams every 12 hours for 1 day
+- Chickenpox (2 to < 18 years of age): 20 mg/kg 3 times daily for 5 days; not to exceed 1 gram 3 times daily
+
",,"No dosage adjustment is recommended when valacyclovir is coadministered with digoxin, antacids, thiazide diuretics, cimetidine or probenecid in subjects with normal renal function.
","Valacyclovir is contraindicated in patients with a known hypersensitivity or intolerance to valacyclovir, acyclovir, or any component of the formulation.
","The most frequently reported adverse reactions were nausea (15%), headache (14%), vomiting (6%), dizziness (3%) and abdominal pain (3%).
","Pregnancy category B. Valacyclovir was not teratogenic in rats or rabbits at 10 and 7 times human plasma levels, respectively, during the period of major organogenesis. There is no adequate and well-controlled studies of valacyclovir in pregnant women.
Nursing Mothers: Unchanged valacyclovir was not detected in maternal serum, breast milk, or infant urine. Valacyclovir should be administered to a nursing mother with caution and only when indicated.
","Dosage reduction is recommended when administering valacyclovir to patients with renal impairment. Similar caution should be exercised when administering valacyclovir to geriatric patients and patients receiving potentially nephrotoxic agents. The safety and efficacy of valacyclovir have not been established in immuno compromised patients other than for the suppression of genital herpes in HIVinfected patients
","Pediatric Use: Safety and effectiveness of valacyclovir in pre-pubertal pediatric patients have not been established.
Elderly Use (Over 65 yr.): Elderly patients may require a dose reduction of valacyclovir due to a low body weight or disorders (renal, CNS etc.) associated with aging.
",,,,"Store in cool & dry place, away from children.
",11
+1114,Ursodeoxycholic Acid,ursodeoxycholic-acid-1114,,Anti-gallstones drugs: Bile Acids,Primary biliary cirrhosis,"Ursodeoxycholic Acid is indicated for the treatment of
+
+- Cholestasis (Jaundice)
+- Viral Hepatitis
+- Alcoholic Fatty Liver
+- Primary Billiary Cirrhosis (PBC)
+- Primary Sclerosing Cholangitis (PSC)
+- Dissolution of Gallstones and Non-Alcoholic Steato Hepatitis (NASH).
+
","Anti-gallstones drugs: Bile Acids
","Ursodeoxycholic Acid is a naturally occurring bile acid used to treat different hepatobilliary disorders. The activity of Ursodeoxycholic Acid is achieved through a decrease in secretion of cholesterol in bile. Ursodeoxycholic Acid achieves this through a few mechanisms: it reduces cholesterol absorption, suppresses liver cholesterol synthesis and it does not inhibit bile acid synthesis.
Therefore, alters bile composition from supersaturated to unsaturated. Ursodeoxycholic Acid also promotes the formation of liquid cholesterol crystal complexes which enhance removal of the cholesterol from the gallbladder into the intestine to be expelled. Ursodeoxycholic Acid improves cholestatic liver diseases by-
+
+- Protecting cholangiocytes against cytotoxicity of hydrophobic bile acids
+- Stimulating hepatobilliary secretion
+- Protecting hepatocytes against bile acid-induced apoptosis
+
+Ursodeoxycholic Acid is completely absorbed in the upper intestine. Time to peak serum concentration varies from 30 to 150 minutes. The rate of absorption ranges from 60-80%. After absorption Ursodeoxycholic Acid enters the portal vein and undergoes extraction from portal blood by liver where it is conjugated with amino acid & that may be either glycine or taurine and then secreted into the hepatic bile ducts. Small quantities of Ursodeoxycholic Acid appear in the circulation and very small amounts are excreted into urine. The biologic half life of Ursodeoxycholic Acid ranges from 3.5-5.8 days.
","Dissolution of Gall stones: 8-12 mg/kg/day either as single night time dose or in divided doses.
Primary Billiary Cirrhosis: 10-15 mg/kg/day in 2-4 divided doses.
Acute Viral Hepatitis: 600 mg/day.
Alcoholic Fatty Liver: 300 mg/day.
Primary Sclerosing Cholangitis: 25-30 mg/kg/day.
Dissolution of Gallstones and Non-Alcoholic Steato Hepatitis: 13-15 mg/kg/day.
",,"Ursodeoxycholic Acid should not be used with drugs, such as oestrogenic hormones, that increase bile cholesterol. Concomitant administration with bile-acid binding drugs including antacids, charcoal and cholestyramine should be avoided, since this may reduce the effectiveness of therapy with Ursodeoxycholic acid.
","Non-functioning gall-bladder calcified and pigmented gallstones, inflammatory bowel disease.
","Commonly reported side effects are nausea, vomiting, diarrhoea, gallstone opacilication, pruritus.
","Pregnancy category B. No evidence of harm has been reported in pregnancy. It has been effectively used for the treatment of cholestasis of pregnancy during the last trimester without any side effects. Problems have not been documented in humans regarding breast feeding.
","It should be used cautiously in those with liver disease.
",,,,,"Store below 25° C. Protected from light and moisture. Keep the medicine out of the reach of children.
",10
+1231,Urokinase,urokinase-1231,https://medex.com.bd/attachments/dWHtHKFYuemhfQZkX0OX3sqvKdXZeG/urokinase-prescribing-information,Fibrinolytics (Thrombolytics),Thromboembolism,"Urokinase injection is indicated in adults:
+
+- For the lysis of acute massive pulmonary emboli, defined as obstruction of blood flow to a lobe or multiple segments.
+- For the lysis of pulmonary emboli accompanied by unstable hemodynamics, i.e., failure to maintain blood pressure without supportive measures.
... Read more
Urokinase injection is indicated in adults:
+
+- For the lysis of acute massive pulmonary emboli, defined as obstruction of blood flow to a lobe or multiple segments.
+- For the lysis of pulmonary emboli accompanied by unstable hemodynamics, i.e., failure to maintain blood pressure without supportive measures.
+
+The diagnosis should be confirmed by objective means, such as pulmonary angiography or noninvasive procedures such as lung scanning.
","Fibrinolytics (Thrombolytics)
","Urokinase is used for the treatment of pulmonary embolisms. The low molecular weight form of human urokinase consists of an A chain of 2,000 daltons linked by a sulfhydryl bond to a B chain of 30,400 daltons. Urokinase is an enzyme (protein) produced by the kidney, and found in the urine. There are two forms of urokinase which differ in molecular weight but have similar clinical effects. Urokinase is the low molecular weight form. Urokinase acts on the endogenous fibrinolytic system. It converts plasminogen to the enzyme plasmin. Plasmin degrades fibrin clots as well as fibrinogen and some other plasma proteins.
Urokinase acts on the endogenous fibrinolytic system. It cleaves the Arg-Val bond in plasminogen to produce active plasmin. Plasmin degrades fibrin clots as well as fibrinogen and other plasma proteins.
","Deep vein thrombosis: Initial loading dose of 4,400 IU/kg in 15 mL soln over 10 min, followed by 4,400 IU/kg/hr IV infusion for 12-24 hr.
Pulmonary embolism: Initial loading dose of 4,400 IU/kg in 15 mL soln over 10 min followed by 4,400 IU/kg/hr IV infusion for 12 hr.
Peripheral vascular occlusion: Infuse 2,500 IU/mL (500,000 IU in 200 mL) into clot at a rate of 4,000 IU/min for 2 hr.
Advance the catheter into the remaining occluded area & infuse at 4,000 IU/min for another 2 hr. This may be repeated up to 4 times.
Hyphaema: 5,000 IU in 2 mL saline soln is injected and withdrawn repeatedly over the iris. If residual clot remains, leave 0.3 mL in the anterior chamber for 24-48 hr to facilitate further dissolution.
Clotted arterio-venous shunts: Instill 5,000-25,000 IU into affected shunt limb & clamp for 2-4 hr, followed by aspiration of lysate. Repeat if necessary.
",,"Concomitant use of oral anticoagulant or heparin & drugs that affect platelet function may increase risk of haemorrhage.
","Recent surgery or biopsy, severe HTN, severe hepatic or renal insufficiency. Pregnancy & immediate postpartum period.
","Overt bleeding, haemorrhagic complications, fever, haematuria, initial severe pain & dull ache in shunt limb.
","Pregnancy Category B. Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1sttrimester (and there is no evidence of a risk in later trimesters).
","GI lesions & in multiple intracardiac or intravascular punctures as a consequence of cardiopulmonary resuscitation.
",,"If severe haemorrhage occurs, treatment with Urokinase-GCC must be stopped. Aprotinin and synthetic inhibitors eg, epsilon aminocaproic acid, tranexamic acid or p-aminomethylbenzoic acid can be used to inhibit the fibrinolytic action of Urokinase-GCC. In serious cases, human fibrinogen, Factor XIII, Cohn-Fraction I, packed red cells or whole blood can be given, as appropriate.
",,,,10
+1364,Urea (25%),urea-25-1364,https://medex.com.bd/attachments/aik19z1cysJNOB6ASQQqyFqt0hlM8R/urea-25-prescribing-information,Topical urea preparations,Hyperkeratosis,"Adults & children over 12 years: It is intended to be used for the symptomatic treatment of heels & feet anhydrosis including in consumers and diabetics.
","Topical urea preparations
","Topical urea is bacteriostatic, bactericidal, fungistatic, proteolytic, hygroscopic and has mild local anesthetic properties. These actions are dose-dependent. Most of its therapeutic application depends on its hygroscopic properties. The hygroscopic property is due to its ability to cause a configurational change in proteins in the stratum corneum. Urea gently dissolves the intracellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Therapeutic effects depend on local concentrations, not on systemic absorption of the drug. If absorbed, urea would be excreted unchanged in the urine.
","Apply enough Urea 25% Cream to cover affected area, once or twice daily or as directed by the physician. For external use only.
",,"No hazardous drug interaction has been reported.
","Allergy to any of the ingredients of this product.
","No serious toxicity has been reported with topical urea. Historically it is considered a safe drug. But on some occasions, topical urea has been shown to cause burning and irritation, if applied to inflamed, broken or exudative skin eruptions.
","There are no adequate & well-controlled studies in pregnant women. Urea should only be used if the anticipated benefits outweigh the risks.
","Avoid contact with eyes. Do not use, if sensitive to any of the ingredients, on genitals or other areas of sensitive skin, on skin that is badly cracked, infected or bleeding and at the same time as other skin care products. Stop use if skin irritation or rash occurs during use.
",,,,,"Store in a cool & dry place, protect from light. Do not freeze.
",10
+1113,Urea (10%),urea-10-1113,https://medex.com.bd/attachments/Z6jGNM9xTUvT4lpvQjV7GIsH2lk4Gx/urea-10-prescribing-information,Topical urea preparations,Psoriasis,"Urea 10% cream is indicated for-
+
+- Ichthyosis and dry skin conditions
+- Management of eczemas
+- Management of psoriasis
+
","Topical urea preparations
","Topical urea is bacteriostatic, bactericidal, fungistatic, proteolytic, hygroscopic and has mild local anesthetic properties. These actions are dose dependent. Most of its therapeutic applications depend on its hygroscopic properties. The hygroscopic property is due to its ability to cause configurational change in proteins in the stratum corneum. A 10% urea cream has been shown to increase the water holding capacity of ichthyotic scale by 100% after 3 weeks of treatment. There is no information available about percutaneous absorption of urea. Therapeutic effects depend on local concentrations, not on systemic absorption of the drug. If absorbed, urea would be excreted unchanged in the urine.
","Urea 10% cream is applied topically. Wash affected areas well, rinse off all traces of soap, dry and apply sparingly twice daily. Occlusive dressings may be used, but are usually unnecessary because of the self-occlusive nature of the cream.
Use in children: Urea 10% cream can be used in all age groups.
",,"No hazardous drug interaction has been reported.
","This is contraindicated in any other ingredient of this preaparation.
","No serious toxicity has been reported with topical urea. Historically it is considered a safe drug. But on some occasions, topical urea has been shown to cause burning and irritation, if applied to inflamed, broken or exudative skin eruptions.
","Urea cream can be used during pregnancy and lactation.
","In some instances, urea 10% cream may cause local irritation and edema, when applied to sensitive skin. If the condition is aggravated or there is no improvement the doctor should be consulted. Avoid application to moist or broken skin.
",,,,,"Keep out of the reach of children. Do not freeze. Keep at cool and dry place.
",10
+1886,Upadacitinib,upadacitinib-1886,https://medex.com.bd/attachments/O4ATTmdXvfkPAYj9fXfLD3MVH50iFN/upadacitinib-prescribing-information,Drugs used for Rheumatoid Arthritis,Rheumatoid arthritis,"Upadacitinib is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with moderate to severe active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
","Drugs used for Rheumatoid Arthritis
","Upadacitinib is a Janus kinase (JAK) inhibitor. JAKs are intracellular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function. Within the signaling pathway, JAKs phosphorylate and activate Signal Transducers and Activators of Transcription (STATs) which modulate intracellular activity including gene expression. Upadacitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs.
","The recommended dose of Upadacitinib is 15 mg once daily. Upadacitinib may be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs. Avoid initiation or interrupt Upadacitinib if absolute lymphocyte count is less than 500 cells/mm3, absolute neutrophil count is less than 1000 cells/mm3 or hemoglobin level is less than 8 g/dL.
Pediatric Use: The safety and efficacy of Upadacitinib in children and adolescents aged 0 to 18 years have not yet been established. No data are available.
",,"Strong CYP3A4 Inhibitors: Upadacitinib exposure is increased when co-administered with strong CYP3A4 inhibitors (such as ketoconazole). Upadacitinib should be used with caution in patients receiving chronic treatment with strong CYP3A4 inhibitors.
Strong CYP3A4 Inducers: Upadacitinib exposure is decreased when co-administered with strong CYP3A4 inducers (such as rifampin), which may lead to reduced therapeutic effect of Upadacitinib. Coadministration of Upadacitinib with strong CYP3A4 inducers is not recommended.
",,"Adverse reactions (greater than or equal to 1%) are: upper respiratory tract infections, nausea, cough, and pyrexia.
","The limited human data on use of Upadacitinib in pregnant women are not sufficient to evaluate a drug-associated risk for major birth defects or miscarriage. Based on animal studies, upadacitinib has the potential to adversely affect a developing fetus. Advise not to breastfeed.
","
+- Serious Infections: Avoid use of Upadacitinib in patients with active, serious infection, including localized infections.
+- Malignancy: Consider the risks and benefits of Upadacitinib treatment prior to initiating therapy in patients with a known malignancy.
+- Thrombosis: Consider the risks and benefits prior to treating patients who may be at increased risk of thrombosis. Promptly evaluate patients with symptoms of thrombosis and treat appropriately.
+- Gastrointestinal Perforations: Use with caution in patients who may be at increased risk.
+- Laboratory Monitoring: Recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes and lipids.
+- Embryo-Fetal Toxicity: Upadacitinib may cause fetal harm based on animal studies. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
+- Vaccinations: Avoid use of Upadacitinib with live vaccines.
+
",,"Upadacitinib was administered in clinical trials up to doses equivalent in daily AUC to 60 mg extended-release once daily. Adverse events were comparable to those seen at lower doses and no specific toxicities were identified. Approximately 90% of upadacitinib in the systemic circulation is eliminated within 24 hours of dosing (within the range of doses evaluated in clinical studies). In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions. Patients who develop adverse reactions should receive appropriate treatment.
",,,"Do not store above 25°C. Protect from light. Keep out of reach of children.
",10
+2041,Undenatured Type II Collagen + Glucosamine Sulfate + Chondroitin Sulfate,undenatured-type-ii-collagen-glucosamine-sulfate-chondroitin-sulfate-2041,,Specific mineral preparations,Rheumatoid arthritis,"The drug is indicated to treat osteoarthritis, rheumatoid arthritis, other joint pain & inflammation associated with injury and impaired joint function.
","Specific mineral preparations
","Glucosamine is a naturally occurring amino sugar of cartilage that provides the basic raw material needed by the body to manufacture joint cartilage. Chondroitin is another naturally occurring mucopolysaccharide of cartilage that stimulates cartilage production, inhibits cartilage destroying enzymes, draws fluid to the cells and helps lubricate the joints. Glucosamine and Chondroitin work synergistically together to help stimulate the production and regeneration of connective tissues (e.g., cartilage, bone, tendon, skin, mucous membrane, blood vessels etc.). Undenatured Type II Collagen also known as Chicken Collagen Type II that works by oral tolerization. This Undenatured type II Collagen contains epitopes that interacts with the peyer’s patch in the intestine. It prevents the immune system from releasing destructive collagen specific T-cell. This T-cell is responsible for degradation of collagen in the joints. This causes halting the erosion of joint cartilage. As inflammation subsides the disequilibrium of cartilage turnover shifts in favor of rebuilding. It appears that once the destructive cycle is broken, the joint cartilage begins to repair itself through collagen building activities that are part of normal cartilage remodelling process.
","1 tablet daily with meal or as directed by the physician.
",,"There is no known drug interaction with Undenatured type II Collagen, Glucosamine and Chondroitin.
",,"Generally safe for most of the people but some may feel stomach problems.
","There is not enough reliable information about the safety of taking the drug if you are pregnant or breast feeding. So it is better to avoid the drug during pregnancy and lactation.
",,,"Abdominal discomfort may happen in case of overdose of drug.
",,,"Do not store above 30⁰C. Protect from moisture and light and keep out of the reach of the children.
",9
+2038,Undenatured Type II Collagen + Glucosamine sulfate + Boswellia serrata + Boron,undenatured-type-ii-collagen-glucosamine-sulfate-boswellia-serrata-boron-2038,,Specific mineral & vitamin combined preparations,Osteoarthritis (degenerative arthritis),"This preparation is indicated in-
+
+- Osteoarthritis & rheumatoid arthritis
+- Difficulties in flexibility & mobility
+- Joint pain & inflammation
+- Joint discomfort & stiffness (knee extension)
+- Impaired joint function
+
","Specific mineral & vitamin combined preparations
","Undenatured Type II collagen (UC-II): Undenatured Type II collagen (UC-II) is a nutritional supplement derived from chicken sternum cartilage using a patented, low-temperature, non-enzymatic manufacturing process that preserves the natural triple helix molecular configuration and its biological activity. UC-II has unique mechanism of action. UC-II molecules contain active binding sites called epitopes which trigger the process of oral tolerization. Through oral tolerization process, active epitopes of UC-II interact with Peyer’s patches (lymphoid tissue) of small intestine and it transforms T-cells into T- regulatory cells. T-regulatory cells then migrate to joint area and secrete anti-inflammatory mediators (cytokines), including the transforming growth factor-beta (TGF beta) and interleukin 10 (IL-10). Thus it reduces joint inflammation and promotes cartilage repair. According to ORSI (osteoarthritis research society international), oral administration of UC-II diminished deterioration of articular cartilage of osteoarthritis (OA).
Glucosamine sulfate: Glucosamine sulfate is a natural supplement. It is a sugar protein that helps build cartilage. Glucosamine, a normal constituent of glycosaminoglycans in cartilage matrix and synovial fluid, could have various pharmacological actions in articular cartilage and joint tissues. In randomized, placebo-controlled clinical trial, long-term administration of glucosamine sulfate can prevent joint structure changes in patients with osteoarthritis of the knee with a significant improvement in symptoms.
Boswellia serrata: This plant extract promotes joint health by inhibiting inflammatory factors such as the 5-lipoxygenase (5-LOX) enzyme and leukotriene B4, which affect aging joints. Extract of Boswellia serrata has been clinically studied for osteoarthritis, joint function & joint pain. Boswellia may also help reduce cartilage damage in arthritis. In a placebo-controlled clinical study, Boswellia extract improves signs of joint discomfort in just 8 weeks. Boswellia serrata as a promising alternative to NSAIDs.
Boron (calcium fructoborate): It is a patented complex of calcium, fructose & boron found naturally in fresh and dried fruits, vegetables and herbs. Calcium fructoborate significantly reduces the C-reactive protein in humans. This unique plant-mineral complex is contribute to bone health by controlling the inflammation associated with loss of bone mineral density.
","Adult dose: 1 tablet orally twice daily after meal. Or as directed by the physician.
Use in children & adolescents: Safety and effectiveness in children patients below 12 years of age have not been established.
",,"There have been no reports of significant drug Interactions of UC-II, Boswellia serrata, Glucosamine sulfate, Calcium fructoborate. But in case of Glucosamine sulfate & Boswellia serrata there are a chance of drug interaction with blood thinner medications (e,g warfarin & heparin).
","Contraindicated in patients with known hypersensitivity to chicken, egg & shellfish.
","The combination of Undenatured Type II collagen, Glucosamine, Boswellia & Boron is generally well-tolerated in the recommended dose. Overdose may cause headache & constipation.
","Not recommended duration pregnancy and lactation.
","No special studies were confirmed in patients with renal and/or hepatic insufficiency. However, administration to these patients with severe renal or hepatic insufficiency should be under appropriate medical supervision.
",,"The signs and symptoms of overdose include nausea, vomiting, diarrhoea, constipation and abdominal discomfort.
",,,"Store below 30° C temperature & in dry place, protected from light. Keep out of the reach of children.
",11
+1540,Undenatured Type II Collagen,undenatured-type-ii-collagen-1540,,Specific mineral preparations,Osteoarthritis (degenerative arthritis),"Undenatured Type II Collagen capsule is indicated for-
+
+- Osteoarthritis
+- Rheumatoid arthritis
+- Joint pain & inflammation
+- Difficulties in flexibility & mobility
+- Joint discomfort & stiffness (knee extension)
+- Impaired joint function
+- Strenuous exercise & sports
+
","Specific mineral preparations
","Undenatured Type II Collagen derived from chicken sternum cartilage using a patented, low-temperature, non-enzymatic manufacturing process that preserves the natural triple helix molecular configuration and its biological activity. Undenatured collagen II has unique mechanism of action. Undenatured collagen II molecules contain active binding sites called epitopes which trigger the process of oral tolerization. Through oral tolerization process, active epitopes of undenatured collagen II interact with Peyer’s patches (lymphoid tissue) of small intestine to release collagen-specific regulatory T-cells. Collagen-specific regulatory T-cells then migrate to joint areas and prevent release of T-cells.
Preventing the release of T-cells prevent the secretion of collagenase enzymes by macrophages responsible for breakdown of collagen in joint cartilage. It also slows the production of inflammatory cytokines resulting in reduction of inflammation, halting the erosion of joint cartilage and promote cartilage rebuilding. Undenatured Type II Collagen supports joint function, mobility and flexibilityand also improves knee extension by up to 10% for better range of motion. It also relieves joint pain due to strenuous exercise.
","Orally 1 capsule daily with water or as directed by the physician.
",,"Not known.
","Contraindicated in patients with known hypersensitivity to chicken or egg.
","Undenatured Type II Collagen is generally well tolerated in recommended dose. Over dose may cause constipation and headache.
","Lack of scientific evidence on the use of undenatured collagen II during pregnancy or lactation.
",,,,,,"Keep away from direct sunlight and moisture, Store below 30°C temperature in cool and dry place. Keep the medicine out of reach of children.
",9
+1363,Ulipristal Acetate [For uterine fibroids],ulipristal-acetate-for-uterine-fibroids-1363,https://medex.com.bd/attachments/ATz1tK4RFRFjg9phSVf8W2kuoB15A9/ulipristal-acetate-for-uterine-fibroids-prescribing-information,Drugs acting on the Uterus,Uterine fibroids,"Ulipristal Acetate is used before surgery to treat moderate to severe symptoms of uterine fibroids, which are noncancerous (benign) tumors of the womb (uterus). Ulipristal Acetate is used in adult women who have not yet reached menopause.
","Drugs acting on the Uterus
","Ulipristal acetate is a selective progesterone receptor modulator. It acts by blocking the receptor of a hormone in the body called progesterone, which is involved in controlling the growth of the lining of the womb. In some women, progesterone may promote the growth of fibroids, which may cause symptoms such as heavy uterine bleeding, anaemia and abdominal pain. When progesterone activity is blocked, fibroid cells stop dividing and eventually die which reduces the size of the fibroids and reduces the symptoms caused by them.
","Ulipristal acetate is taken by mouth and the recommended dose is one tablet (5 mg) a day for up to three months. The three month treatment can be repeated but only once. Treatment should always be started during the first week of the menstrual cycle (period bleeding).
",,,"Contraindicated in patients with-
+
+- Hypersensitivity to the active substance or to any of the excipients.
+- Pregnancy and breastfeeding.
+- Genital bleeding of unknown aetiology or for reasons other than uterine fibroids.
+- Uterine, cervical, ovarian or breast cancer.
+
","Common side effects are Endometrial thickening, Hot flush, Headache, Uterine haemorrhage
","Pregnancy Category X. Ulipristal acetate is contraindicated during pregnancy. Ulipristal acetate is excreted in human milk and is not recommended.
","Ulipristal acetate should only be prescribed after careful diagnosis and Pregnancy should be precluded prior to treatment.
+
+- Contraception: Concomitant use of progestagen-only pills, a progestagen releasing intrauterine device or combined oral contraceptive pills is not recommended. Although a majority of women taking a therapeutic dose of ulipristal acetate have anovulation, a non-hormonal contraceptive method is recommended during treatment.
+- Endometrial Changes: Endometrial Thickening or Progesterone receptor modulator Associated Endometrial Changes (PAEC). Ulipristal acetate has a specific pharmacodynamic action on the endometrium. An increase in thickness of the endometrium may occur. The thickness of the endometrium decreases to baseline levels upon treatment cessation. If the endometrial thickening persists beyond 3 months following the end of treatment and return of menstruations, this may need to be investigated as per usual clinical practice to exclude underlying conditions.
+- Bleeding Pattern: Patients should be informed that treatment with ulipristal acetate usually leads to a significant reduction in menstrual blood loss or amenorrhea within the first 10 days of treatment. Should the excessive bleeding persist, patients should notify their physician.
+- Asthma Patients: Use in women with severe asthma insufficiently controlled by oral glucocorticoids is not recommended.
+
","Hepatic Impairment: Ulipristal acetate is not recommended in patients with severe hepatic impairment unless the patient is closely monitored.
Renal Impairment: Renal impairment is not expected to significantly alter the elimination of ulipristal acetate. In the absence of specific studies, ulipristal acetate is not recommended for patients with moderate and severe renal impairment unless the patient is closely monitored.
","Experience with ulipristal acetate overdose is limited. Single doses up to 200 mg and daily doses of 50 mg for 10 consecutive days were administered to a limited number of subjects, and no severe or serious adverse reactions were reported.
",,,"Keep protected from light & moisture, store below 25° C. Keep out of reach of children.
",11
+1154,Ulipristal Acetate [For emergency contraception],ulipristal-acetate-for-emergency-contraception-1154,https://medex.com.bd/attachments/GhbyacVFhXlHUpSgbuItNstQmYHeCS/ulipristal-acetate-for-emergency-contraception-prescribing-information,Drugs acting on the Uterus,Uterine fibroids,"Ulipristal Acetate is indicated for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.
","Drugs acting on the Uterus, Emergency Contraceptive Pill
","Ulipristal Acetate is an orally-active synthetic SPRM that acts via high-affinity binding to the human progesterone receptor. The primary mechanism of action is inhibition or delay of ovulation. Data shows that even when taken immediately before ovulation is scheduled to occur, Ulipristal Acetate is able to postpone follicular rupture in some women.
","One 30 mg tablet must be taken as soon as possible but no later than 120 hours of unprotected intercourse or contraceptive failure, with or without food. If vomiting occurs within 3 hours of intake, then another tablet needed to be taken. Ulipristal Acetate can be taken at any time of menstrual cycle.
",,"Ulipristal Acetate interacts with the following drugs: Barbiturates, Carbamazepine, Phenobarbital, Rifampicin, Itraconazole, Ketoconazole etc.
","Ulipristal Acetate is contraindicated in case of hypersensitivity to active substances and in pregnancy.
","Most common side-effects are headache, nausea, abdominal pain, dysmenorrhea, fatigue, dizziness, breast tenderness etc.
","Contraindicated in suspected or existing pregnancy. Ulipristal Acetate excretes in breast milk. So breastfeeding is not recommended for one week after intake. Extremely limited data are available on the health of the fetus/newborn exposed to Ulipristal acetate.
","Existing Pregnancy: Ulipristal Acetate is not indicated for termination of an existing pregnancy.
Ectopic Pregnancy: A history of ectopic pregnancy is not a contraindication to the use of this emergency contraceptive method.
Repeated Use: Ulipristal Acetate is for occasional use as an emergency contraceptive. It should not replace a regular method of contraception. Repeated use of Ulipristal Acetate within the same menstrual cycle is not recommended, as safety and efficacy of repeat use within the same cycle has not been evaluated.
Fertility Following Use: A rapid return of fertility is likely following treatment with Ulipristal Acetate for emergency contraception. So, to prevent pregnancy on a later episode of sexual intercourse one should use the barrier method (ex. Condom).
Effect on Menstrual Cycle: After Ulipristal Acetate intake, menses sometimes occur earlier or later than expected by a few days. In clinical trials, cycle length was increased by a mean of 2.5 days but returned to normal in the subsequent cycle. 7% of subjects reported menses occurring more than 7 days earlier than expected, and 19% reported a delay of more than 7 days. If there is a delay in the onset of expected menses beyond 1 week, a pregnancy test should be performed. 9% of women studied reported intermenstrual bleeding after the use of Ulipristal Acetate.
","Children and Adolescents: Limited safety and efficacy data available on women under 18 years old.
Hepatic Impairment: No studies have been conducted to evaluate the effect of hepatic disease on the disposition of Ulipristal Acetate.
Renal Impairment: No studies have been conducted to evaluate the effect of renal disease on the disposition of Ulipristal Acetate.
","Experience with Ulipristal Acetate overdose is limited, in a clinical study, a single dose equivalent to four times Ulipristal Acetate was administered to a limited number of subjects without any adverse reactions.
",,,"Store in a dry and cool place, protected from sunlight. Do not freeze. Keep out of reach of children.
",12
+1112,Typhoid Polysaccharide Vaccine,typhoid-polysaccharide-vaccine-1112,https://medex.com.bd/attachments/VezSdNfCscum1Qh2IVTdVMHvrj3Exg/typhoid-polysaccharide-vaccine-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Active immunization against typhoid fever,"Typhoid Polysaccharide Vaccine is indicated for active immunization against typhoid fever for adults and children two years of age or older. Selective immunization with typhoid vaccine is recommended for the following:
+
+- Travellers to high endemic areas
+- Household contact of carriers
... Read more
Typhoid Polysaccharide Vaccine is indicated for active immunization against typhoid fever for adults and children two years of age or older. Selective immunization with typhoid vaccine is recommended for the following:
+
+- Travellers to high endemic areas
+- Household contact of carriers
+- Healthcare personnel
+- Police, Armed forces and such other regimented personnel
+- Laboratory workers who work with Salmonella typhi
+
","Vaccines, Anti-sera & Immunoglobulin
",,"Dosage: A single dose of 0.5 ml is recommended for both adults and children 2 years of age or older. Subjects who remain at risk of typhoid fever should be given a single booster dose of the vaccine with an interval of not more than 3 years.
Administration: Typhoid Polysaccharide Vaccine is for intramuscular injection only. Do not inject intravenously. This should be given intramuscularly in the deltoid and children should be injected intramuscularly either in the deltoid or the vastus lateralis. It should not be injected into the gluteal areas where there may be a nerve trunk. Typhoid Polysaccharide Vaccine injection should be administered with caution to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these subjects. Following injection, firm pressure should be applied to the site (without rubbing) for at least two minutes.
Co-administration: Typhoid vaccine can be co-administered with other vaccines but should not be mixed with other vaccines or medicinal products in the same syringe.
",,,"The vaccine protects against typhoid fever caused by Salmonella typhi. Protection is not conferred against paratyphoid fever or illness caused by non-invasive Salmonella. Typhoid vaccine should not be administered to subjects with known hypersensitivity to any component of the vaccine or to subjects having shown signs of hypersensitivity after previous Typhoid vaccine administration or after any other vaccine containing Vi polysaccharide Salmonella typhi antigens. It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate response may not be achieved. The administration of Typhoid vaccine should be postponed in subjects suffering from acute severe febrile illness.
","Most recepients of Typhoid vaccine experience some reactions upon vaccination. These are generally moderate and short in duration. They mainly consist of local reactions at the injection site (erythema, induration and tenderness). Systemic reactions (malaise, headache, diarrhea, vomiting, myalgia and elevated temperature) are reported less commonly. In very rare cases allergic type reactions (pruritus, rash, urticaria) may be observed.
","The effect of Typhoid vaccine on foetal development or reproduction capacity has not been evaluated. Typhoid vaccine should only be used during pregnancy when there is a high risk of infection. It is not known if Typhoid vaccine is excreted in human milk. It may be administered to nursing mothers only if clearly needed.
",,,,,,"Keep out of the reach of children. Store at +2°C to +8°C. Transportation should also be at +2°C to +8°C. Do not freeze. Discard vaccine if frozen. Protect from light.
",7
+1111,Tulobuterol Hydrochloride,tulobuterol-hydrochloride-1111,https://medex.com.bd/attachments/PaGsSbfCxKHZqWmzwVJ1PUQUp2pwKv/tulobuterol-hydrochloride-prescribing-information,Short-acting selective & β2-adrenoceptor stimulants,Chronic obstructive pulmonary disease (COPD),"Tulobuterol is indicated for prophylaxis and control of bronchospasm in bronchial asthma, chronic bronchitis, asthmatic bronchitis, pulmonary emphysema, bronchiectasis, tracheobronchitis with emphysema and other bronchospastic disorders and conditions characterized by bronchoconstriction. Because oral ... Read more
Tulobuterol is indicated for prophylaxis and control of bronchospasm in bronchial asthma, chronic bronchitis, asthmatic bronchitis, pulmonary emphysema, bronchiectasis, tracheobronchitis with emphysema and other bronchospastic disorders and conditions characterized by bronchoconstriction. Because oral tulobuterol is long acting, it is ideally suited for routine maintenance therapy in chronic asthma and chronic bronchitis. Tulobuterol has been shown in controlled single and multiple-dose studies to be more effective than terbutaline and fenoterol and at least as effective as salbutamol (albuterol) in relieving bronchospasm associated with reversible obstructive airways disease such as asthma, and also chronic bronchitis and emphysema. Clinically significant improvement in pulmonary function, as demonstrated by an increase in FEV of 15% or more, occurred within 30 minutes after oral dosing with peak improvement occurring within two to three hours. In some patients, a therapeutic response was still apparent at 12 hours. Continued effectiveness was demonstrated over a one-year period.
","Short-acting selective & β2-adrenoceptor stimulants
","The primary pharmacological action of beta-adrenergic drugs is to stimulate adenyl cyclase, the enzyme which catalyzes the formation of cyclic-3',5' adenosine monophosphate (cyclic AMP) from adenosine triphosphate (ATP). The cyclic AMP thus formed mediates the cellular response that results in bronchodilation. Tulobuterol, due to its highly selective action on beta-2 adrenoceptors, relaxes the bronchial smooth muscle and has been shown to be clinically successful in the symptomatic treatment of reversible obstructive airways disease (ROAD) such as bronchial asthma, and also in bronchitis and emphysema.
Some bronchodilators stimulate beta-1 (cardiac) receptors in addition to beta-2 receptors and may cause tachycardia, angina, and possibly arrhythmias in susceptible patients. Animal studies and in vitro experiments indicate that tulobuterol is more selective in its beta-2 agonist activity than other agents in this class and, therefore, should produce fewer cardiac side effects.
","As long-term clinical studies have demonstrated, tulobuterol continues to be efficacious and does not result in cumulative or toxic side effects. Due to the variability of the disease and the need for individualized dosage requirements, flexibility in dosing is indispensable.
The use of Long-Acting Beta Agonists is contraindicated without the use of an asthma controller medication such as inhaled corticosteroid.
Long-Acting Beta Agonists should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patient should then be maintained on a long-term asthma controller medication (e.g. Corticosteroids).
Tablets: The usual oral adult dose of tulobuterol is one 2 mg tablet twice a day. A convenient starting dose for children 12 years and over and adults is 1 mg twice a day, particularly for elderly patients and those with a history of sensitivity to beta-adrenergic agents. Unless precluded by drug-related side effects, the patient may have the dose increased after seven to ten days to 2 mg twice a day, if necessary, to achieve a greater therapeutic response.
Although most patients can be maintained on a dose of 1 to 2 mg twice daily, the variability of patient response and severity of symptoms may require further adjustment of the dose, as with any bronchodilator treatment. Therefore, if necessary, the adult dose of tulobuterol may be increased to 6 mg a day in divided doses according to clinical response.
Syrup: Based on dose-ranging studies in children, the usual dose of tulobuterol syrup (1 mg/5 mL) for children is 40 to 80 mcg/kg/day in two divided doses.
In clinical studies in children, the effective dose has ranged from 20 to 100 mcg/kg/day.
This leads to the following recommendations on the basis of age:
+
+- For children aged one to six years, 0.25 tsp. (1.25 mL) to 0.5 tsp. (2.5 mL) BID
+- For children aged six to twelve years, 0.5 tsp. (2.5 mL) to 1 tsp. (5 mL) BID
+- For children aged over twelve years, 1 tsp. (5 mL) to 2 tsp. (10 mL) BID
+- The above age recommended doses may have to be modified according to patient response.
+
",,"Increased risk of arrhythmia with digoxin. Hypokalaemia with concomitant admin of xanthines, corticosteroids and diuretics.
","Administration of tulobuterol is contraindicated in patients with known hypersensitivity to sympathomimetic amines or any of the formulation components.
","The adverse reactions of tulobuterol are similar in nature to those of other sympathomimetic agents, however the incidence of certain cardiovascular effects is less with tulobuterol. Dose-related finger tremor is common with these agents, but the effects tend to lessen with continued administration of the drug. Oral formulations of tulobuterol, like other sympathomimetic agents, can also cause less frequent adverse reactions such as hypertension, palpitations, angina, tachycardia, vomiting, vertigo, central nervous system stimulation, insomnia and headache.
","Safety of this product for use during pregnancy has not been established. It is not known whether tulobuterol is excreted in human breast milk nor whether it has a harmful effect on the newborn. Therefore, as with any medication, the use of the drug in pregnancy, lactation, or women of childbearing potential requires that the expected therapeutic benefit of the drug be weighed against its possible hazards to the mother and child.
","Long-Acting Beta Agonists should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications alone.
Tulobuterol should be used with caution in patients with diabetes mellitus, hypertension, hyperthyroidism, and seizure disorders.
Caution should be observed in patients with renal failure in view of the kidney being the principle route of elimination of the drug. Dosage may also require individualization in patients with impaired liver function as normally tulobuterol is extensively metabolized by the liver.
As with other sympathomimetic bronchodilator agents, tulobuterol should be administered cautiously to cardiac patients, especially those with associated arrhythmias, coronary insufficiency, or myocardial ischemia.
",,,,,,9
+1655,TTO Thermal Toothpaste,tto-thermal-toothpaste-1655,,Miscellaneous topical agents,Dental hypersensitivity,"This toothpaste is indicated in-
+
+- Faster relief from dental hypersensitivity.
+- Sensitivity repair
+- Teeth strengthening
+- Gum protection
+- Teeth whitening
+- Total oral hygiene
+- Plaque control
+- Enamel protection
+- Extra fresh breath
+
","Miscellaneous topical agents
","
+- Patent oral hygiene product
+- Long lasting protection with twice daily brushing
+- Prevent common dental problem
+- FDA categorized human OTC drug label
+- WHO recommended antiseptic & disinfectant
+- European Medicines Agency approved as
+- herbal Medicine Product
+
","Take a small amount of toothpaste on the tooth brush and brush the tooth twice daily for at least one minutes.
",,,,,,,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",5
+1110,Trypan Blue,trypan-blue-1110,https://medex.com.bd/attachments/qbJFULy0Ap1bVP1W6Grr3TRJ7R4XY1/trypan-blue-prescribing-information,Preparations for Ophthalmic diagnosis,Aid in ophthalmic surgery by staining the anterior capsule of the lens,"Trypan Blue is indicated for use as an aid in ophthalmic surgery by staining the anterior capsule of the lens.
","Preparations for Ophthalmic diagnosis
","Trypan Blue is a selective tissue staining agent (dye) which stains anterior lens capsule of the human crystalline lens. The dye does not penetrate the capsule, permitting visualization of the anterior capsule in contrast to the non-stained lens cortex and inner lens material.
","The first step to administer Trypan Blue is to inject an air bubble into the anterior chamber using a 26 gauge needle. It prevents dilution of dye by the aqueous humor. Then Trypan Blue is injected into the anterior lens capsule using a tuberculin syringe. Sufficient staining is achieved as soon as the dye has contracted the capsule. If some area is left unstained, inject one more drop till it gets stained.
",,,"Trypan Blue is contraindicated when a non-hydrated (dry state), hydrophilic acrylic intraocular lens (IOL) is planned to be inserted into the eye because the dye may be absorbed by the IOL and stain the IOL.
","
+- Discoloration of high water content hydrogen intraocular lenses.
+- Inadvertent staining of the posterior lens capsule and vitreous face.
+- It is generally self limited, lasting up to one week.
+
","Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Trypan Blue should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Trypan Blue is administered to a nursing woman.
","It is recommended that after injection all excess Trypan Blue should be immediately removed from the eye by thorough irrigation of the anterior chamber.
","Pediatric use: The safety and effectiveness of Trypan Blue have been established in pediatric patients. Use of Trypan Blue is supported by evidence from an adequate and well controlled study in pediatric patients.
Geriatric use: No overall differences in safety and effectiveness have been observed between elderly and younger patients.
",,,,"Store below 30° C and keep away from light.
",10
+1812,Trospium Chloride,trospium-chloride-1812,https://medex.com.bd/attachments/2o4CB3FlGJPwLSw0UW0GVrAs2MDtqg/trospium-chloride-prescribing-information,Other genito-urinary preparations,Urinary incontinence,"Trospium is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
","Other genito-urinary preparations
","Trospium is a muscarinic antagonist. Trospium chloride antagonizes the effect of acetylcholine on muscarinic receptors in cholinergically innervated organs including the bladder. Its parasympatholytic action reduces the tonus of smooth muscle in the bladder. Receptor assays showed that trospium chloride has negligible affinity for nicotinic receptors as compared to muscarinic receptors at concentrations obtained from therapeutic doses.
","The recommended dose is 20 mg twice daily. Trospium should be dosed at least one hour before meals or given on an empty stomach. Dosage modification is recommended in the following patient populations:
+
+- For patients with severe renal impairment (creatinine clearance less than 30 mL/min), the recommended dose is 20 mg once daily at bedtime.
+- In geriatric patients greater than or equal to 75 years of age, dose may be titrated down to 20 mg once daily based upon tolerability.
+- Pediatric Use: The safety and effectiveness of Trospium in pediatric patients have not been established.
+
",,"Digoxin: Concomitant use of Trospium and digoxin did not affect the pharmacokinetics of either drug.
Drugs Eliminated by Active Tubular Secretion: Although demonstrated in a drug-drug interaction study not to affect the pharmacokinetics of digoxin, Trospium has the potential for pharmacokinetic interactions with other drugs that are eliminated by active tubular secretion (e.g., procainamide, pancuronium, morphine, vancomycin, and tenofovir). Coadministration of Trospium with these drugs may increase the serum concentration of Trospium and/or the coadministered drug due to competition for this elimination pathway. Careful patient monitoring is recommended in patients receiving such drugs.
Antimuscarinic Agents: The concomitant use of Trospium with other antimuscarinic agents that produce dry mouth, constipation, and other anticholinergic pharmacological effects may increase the frequency and/or severity of such effects. Trospium may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility.
Metformin: Co-administration of 500 mg metformin immediate release tablets twice daily with Trospium 60 mg extended release reduced the steady-state systemic exposure of trospium by approximately 29% for mean AUC0-24 and by 34% for mean Cmax.
","Trospium is contraindicated in patients with:
+
+- Urinary retention
+- Gastric retention
+- Uncontrolled narrow-angle glaucoma.
+- Known hypersensitivity to the drug or its ingredients. Angioedema, rash and anaphylactic reaction have been reported.
+
","The following adverse reactions have been identified during post-approval use of trospium chloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
+
+- Gastrointestinal: gastritis
+- Cardiovascular: palpitations, supraventricular tachycardia, chest pain, syncope,
+- hypertensive crisis
+- Immunological: Stevens-Johnson syndrome, anaphylactic reaction, angioedema
+- Nervous System: dizziness, confusion, vision abnormal, hallucinations, somnolence and delirium
+- Musculoskeletal: rhabdomyolysis
+- General: rash
+
","Pregnancy Category C: There are no adequate and well-controlled studies of Trospium in pregnant women. Trospium should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. Women who become pregnant during Trospium treatment are encouraged to contact their physician.
Nursing Mothers: Trospium chloride (2 mg/kg orally and 50 mcg/kg intravenously) was excreted, to a limited extent (less than 1%), into the milk of lactating rats (primarily as parent compound). It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, Trospium should be used during lactation only if the potential benefit justifies the potential risk to the newborn.
","Risk of Urinary Retention: Trospium should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.
Angioedema: Angioedema of the face, lips, tongue, and/or larynx has been reported with trospium chloride, the active ingredient in Trospium. In one case, angioedema occurred after the first dose of trospium chloride. Angioedema associated with upper airway swelling may be life threatening. If involvement of the tongue, hypopharynx, or larynx occurs, Trospium should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.
Decreased Gastrointestinal Motility: Trospium should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention. Trospium ,like other antimuscarinic agents, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis, intestinal atony and myasthenia gravis.
Controlled Narrow-angle Glaucoma: In patients being treated for narrow-angle glaucoma, Trospium should only be used if the potential benefits outweigh the risks and in that circumstance only with careful monitoring.
Central Nervous System Effects: Trospium is associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholinergic effects have been reported, including dizziness, confusion, hallucinations and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how Trospium affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.
Anticholinergic Adverse Reactions in Patients with Moderate Renal Impairment: Trospium is substantially excreted by the kidney. The effects of moderate renal impairment on systemic exposure are not known but systemic exposure is likely increased. Therefore, anticholinergic adverse reactions (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) are expected to be greater in patients with moderate renal impairment
",,"Overdosage with antimuscarinic agents, including Trospium, can result in severe antimuscarinic effects. Supportive treatment should be provided according to symptoms. In the event of overdosage, electrocardiographic monitoring is recommended. A 7-month-old baby experienced tachycardia and mydriasis after administration of a single dose of trospium 10 mg given by a sibling. The baby’s weight was reported as 5 kg. Following admission into the hospital and about 1 hour after ingestion of the trospium, medicinal charcoal was administered for detoxification. While hospitalized, the baby experienced mydriasis and tachycardia up to 230 beats per minute. Therapeutic intervention was not deemed necessary. The baby was discharged as completely recovered the following day.
",,,"Store at controlled room temperature 20°-25°C.
",11
+1129,"Vitamin A, Vitamin B complex, Vitamin C , Vitamin D and Vitamin E",vitamin-a-vitamin-b-complex-vitamin-c-vitamin-d-and-vitamin-e-1129,,Specific combined vitamin preparations,Parenteral nutrition,"This is indicated as a daily multivitamin maintenance dosage for adults and children aged 11 years and above receiving parenteral nutrition. It is also indicated in other situations where administration by the intravenous route is required. Such situations include surgery, extensive burns, fractures ... Read more
This is indicated as a daily multivitamin maintenance dosage for adults and children aged 11 years and above receiving parenteral nutrition. It is also indicated in other situations where administration by the intravenous route is required. Such situations include surgery, extensive burns, fractures and other trauma, severe infectious diseases and comatose states, which may provoke a ""stress"" situation with profound alterations in the body's metabolic demands and consequent tissue depletion of nutrients.
","Specific combined vitamin preparations
","This is a sterile, lyophilized powder for injection/infusion which contains nine water-soluble and three fat soluble vitamins. Mixed micelles is used as a solubilizing agent. It is presented as a lyophilized, orange-yellow, sterile powder that is to be reconstituted with 5ml of Water for injections or other parenteral fluids, (e.g. as 0.9% Sodium chloride or 5% Glucose solution), prior to administration by parenteral route.
","Adults and children aged 11 years and above: 1 vial/day
","The single dose vial is reconstituted by adding 5 ml of sterile Water for injection or other intravenous fluids like 0.9% Sodium Chloride injection or 5% Glucose injection. 5 ml of diluent should be added by means of sterile syringe into the vial and gently mixed to dissolve the lyophilized powder. The entire volume of the resultant solution should then be administered by slow Intravenous injection (at least over 10 minutes) or further diluted for intravenous infusion. To minimize vitamin losses in parenteral nutrition admixtures, add the vitamins immediately prior to administration and complete administration within 24 hours.
","Patients receiving drugs that bind to a1-acid glycoprotein should be closely monitored for increases in response to these drugs, e.g. propranolol, prazosin and quinidine. Folic acid may increase the metabolism of some antiepileptics, such as phenobartbitol, phenytoin and primidone. Pyridoxine can reduce the effect of levo-dopa. Bleomycin can be inactivated by ascorbic acid and riboflavin.
","This is contraindicated in patients with pre-existing hypervitaminosis or known hypersensitivity to any of the active ingredients. This product should not be injected to patients with pre-existing intolerance to thiamine. Similarly, this product should not be administered to patients with impaired hepatic function. This preparation should not be administered to those suffering from hyperparathyroidism due to hypercalcaemic complications.
","Anaphylactic reactions have been reported following large intravenous doses of Thiamine. Urticaria and rash have also been associated with this preparation. There have been very rare reports of anaphylactic reactions following IV injection/infusion with this preparation over 1-4 minutes.
","The use of this preparation has not been studied in human during pregnancy. This should be given to a pregnant woman only if clearly needed. The use of this product in lactating women is not recommended.
","Anaphylactic reactions may occur in allergic subjects who are susceptible to Thiamine (Vitamin B1) and nicotinamide components of this product. Mild allergic reactions such as sneezing or mild asthma are warning signs that further injection/infusion may give rise to anaphylactic shock. Due to glychocolic acid content, repeated and prolonged administration in patients with jaundice of hepatic origin or severe biochemical evidence of cholestatis requires careful monitoring of liver function. Also in the case of impaired kidney function, fat-soluble vitamin levels should be carefully monitored.
","Accumulation of Vitamin A and Vitamin D may be occured with prolonged administration of high doses.
",,,,"Before reconstitution: Store below 25°C. Protect from light and do not freeze.
After reconstitution: The reconstituted product should be used immediately or it should be stored at 2°C to 8°C for no more than 24 hours. Discard any unused portion of the reconstituted solution.
",12
+1156,Vitamin A,vitamin-a-1156,,Vitamin-A preparations,Xerophthalmia,"Illness due to vitamin A deficiency in ophthalmology such as night blindness, xerophthalmia and dermatological such as changes in skin, hair and nails. Concomitant therapy of mucosa illnesses such as sinusitis, bronchitis, in acne vulgaris, ichthyosis, Darier's disease, psoriasis etc. To meet vitmin ... Read more
Illness due to vitamin A deficiency in ophthalmology such as night blindness, xerophthalmia and dermatological such as changes in skin, hair and nails. Concomitant therapy of mucosa illnesses such as sinusitis, bronchitis, in acne vulgaris, ichthyosis, Darier's disease, psoriasis etc. To meet vitmin A demand in growth, resistance to infections and night blindness. This is also indicated to meet vitamin A deficiency after diarrhoea and prophylaxis of measles.
","Vitamin-A preparations
","Beta-carotene, retinol, and retinal have effective and reliable vitamin A activity. Retinal and retinol are in chemical equilibrium in the body and have equivalent antixerophthalmic activity. Retinal combines with the rod pigment, opsin, in the retina to form rhodopsin, necessary for visual dark adaptation.
Vitamin A prevents retardation of growth and preserves the epithe-lial cells' integrity. Normal adult liver storage is sufficient to satisfy two years'requirements of vitamin A. Vitamin A is readily absorbed from the gastrointestinal tract, where the biosynthesis of vitamin A from beta-carotene takes place. Vitamin A absorption requires bile salts, pancreatic lipase, and dietary fat. It is transported in the blood to the liver by the chy lomicron fraction of the lymph. Vitamin Ais stored in Kupffer cells of the liver mainly as the palmitate. Normal serum vitamin A is 80-300 Units per 100 mL (plasma range is 30-70 mcg per dl) and for carotenoids 270-753 Units per 100 mL.The normal adult liver contains approximately 100 to 300 micrograms per gram, mostly as retinol palmitate.
","For Adults: 50000 IU-100000 IU daily up to 200000 IU if necessary.
Children (Above 1 year):
+
+- Night blindness, Bitot's spots, Xerophthalmia: 200000 IU 1st day, 2nd day, 14th day
+- Measles: 200000 IU 1st day, 2nd day
+- Diarrhoea, Respiratory tract infection: 200000 IU every time after disease
+- Severe malnutrition: 200000 IU single-dose or as directed by the registered physician.
+
",,,"Hypervitaminosis of vitamin A. Sensitivity to any of the ingredients in this preparation.
","Vitamin A intoxication includes irritability, vomiting, loss of appetite, headache, dry and pruritic skin, skin desquamation, fatique, pain in ankles and feet, myalgia, loss of body hair, papilledema, nystagmus, liver sclerosis and cirrhosis.
","Safety of amounts exceeding 6,000 Units of vitamin A daily during pregnancy has not been established at this time. The use of vitamin A in excess of the recommended dietary allowance may cause fetal harm when administered to a pregnant woman. Animal reproduction studies have shown fetal abnormalities associated with over-dosage in several species. Malformations of the central nervous system, the eye, the palate, and the urogenital tract are recorded. Vitamin Ain excess of the recommended dietary allowance is contraindicated in women who are or may become pregnant. If vitamin Ais used during pregnancy, or if the patient becomes pregnant while taking vitamin A, the patient should be apprised of the potential hazard to the fetus.
The U.S. Recommended Daily Allowance (RDA) of vitamin A (5,000 Units) is recommended for nursing mothers.
","Ensure Vitamin A free interval after long term therapy with vitamin A. No daily dose over 5000 IU during pregnancy. Vitamin A doses over 50000 IU under medical supervision only.
",,,,,"Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+1128,Vinpocetine,vinpocetine-1128,,Cerebral vasodilator & Neurosensory oxygenator drugs,Ischaemic events,"Acute Cerebro-Vascular Accidents (Strokes): Ischaemic strokes due to cerebral thrombosis, cerebral embolism, acute circulatory disorder, hypertensive crisis; the acute cardiovascular disorders, ischaemic neurological defcit, complete stroke (CS), multiinfarct dementia, cerebral arteriosclerosis ... Read more
Acute Cerebro-Vascular Accidents (Strokes): Ischaemic strokes due to cerebral thrombosis, cerebral embolism, acute circulatory disorder, hypertensive crisis; the acute cardiovascular disorders, ischaemic neurological defcit, complete stroke (CS), multiinfarct dementia, cerebral arteriosclerosis, hypertensive encephalopathy, post-apoplectic conditions with the background of haemorrhagic strokes etc.
Senile Disorder: For relief of psychosomatic symptoms in the elderly due to cerebral insufciency eg. forgetfulness, memory disturbances, slow thinking, lack of concentration, dizziness, mood instability, aphasia, sleep disturbances, vasovegetative symptoms of menopausal syndrome etc.
Visual Disorder: Vascular disorders of the choroid and retina due to arteriosclerosis. Vasospasm, macula degenerations, arterial or venous thrombosis or embolism and glaucoma secondary to the above mentioned disorders.
Hearing Disorder: For the treatment of impaired hearing of vascular or toxic (iatrogenic) origin presbyacusis, meniere's disease, cochleovestibular neuritis, tinnitus and dizziness of labirynth origin.
","Cerebral vasodilator & Neurosensory oxygenator drugs
","Vinpocetine increases cerebral metabolism; it increases glucose and O2 consumption; improves cerebral hypoxia tolerance; shifts glucose metabolism to the energetically more favourable aerobic pathway, but it increases the anaerobic pathway as well; it elevates the ATP concentration and the ATP/AMP ratio in the brain, and elevates the cerebral norepinephrine, dopamine and serotonin levels.
Vinpocetine considerably improves cerebral microcirculation by inhibiting platelet aggregation, reducing the pathologically increased blood viscosity, and increases erythrocyte deformability. It also promotes O2 transport into the tissues by reducing the O2 affinity of erythrocytes.
It selectively and intensely increases cerebral blood flow and the share of the brain in cardiac output, it reduces cerebral vascular resistance without affecting systemic circulation (blood pressure, heart rate, cardiac output, total peripheral resistance). It does not elicit steal phenomenon; on the contrary, it primarily improves the blood supply of the injured and ischaemic area while it remains unchanged in the intact areas (inverse steal effect). It further increases blood flow which is already increased as a result of hypoxia.
","Tablet: 1-2 tablets thrice daily, the maintenance dose is 1 tablet thrice daily.
IM Injection: Daily dose of 20-40 mg are to be given until improvement of symptoms is reached (for not longer than 10 days) then oral treatment should be applied. If this regimen fails, infusion treatment should be started.
IV Infusion: The daily starting dose is 20 mg in slow drip infusion (2 ampoules in 500-1000 ml infusion solution). This dose can be increased to 1 mg/kg body weight during 3 to 4 days. Treatment should be continued for 10-14 days depending on the tolerance of the patients and the dose should be gradually reduced before discontinuation of treatment.
",,"The injection is chemically incompatible with heparin, therefore, it should not be injected in the same syringe.
","Parenteral treatment- Severe ischaemic heart disease, severe rhythm disorders and pregnancy.
","Transient hypotension, tachycardia may occur.
","In Pregnancy and Lactation the drug is contraindicated.
","In the acute stage until the improvement of symptoms parenteral treatment is recommended followed by oral treatment. In chronic cases oral therapy should be applied.
",,,,,"Store in a cool and dry place, protected from light and moisture.
",10
+1246,Vinorelbine Tartrate,vinorelbine-tartrate-1246,https://medex.com.bd/attachments/Z7wn5LRjcOm06ED7BWY3NygHQLhRY3/vinorelbine-tartrate-prescribing-information,Cytotoxic Chemotherapy,Non-small cell lung cancer,"Vinorelbine is indicated:
+
+- In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
+- As a single agent, for the treatment of patients with metastatic NSCLC
+
","Cytotoxic Chemotherapy
","Vinorelbine, a semisynthetic vinblastine derivative, binds to tubulin and inhibits microtubule formation. This disrupts the formation of the mitotic spindle thereby arresting the cell at metaphase.
","Intravenous (Adult):
+
Cervical cancer: 30 mg/m
2 days 1 and 8 of a 21-day treatment cycle.
Breast cancer, Ovarian cancer: 25 mg/m
2 dose every 7 days.
Non-small cell lung cancer:
+
+- As single agent: 30 mg/m2 wkly as infusion over 20-30 minutes (after diluting in 125 ml normal saline or glucose 5%) or as slow bolus over 5-10 minutes (after diluting in 20-50 ml normal saline or glucose 5%). Delay subsequent doses if neutrophil count is <2000 cells/mm3 until recovery.
+- As combination therapy with cisplatin: 25-30 mg/m2 every 7 days.
+
+
+
Oral (Adult):
+
Non-small cell lung cancer: 60 mg/m
2once wkly for 3 wk, may increase subsequently to 80 mg/m
2 once wkly. If neutrophil count is < 500 cells/mm3 or between 500-1000 cells/mm3 on 2 separate occasions, keep dose at 60 mg/m
2 for next 3 doses.
",,"Increased risk of granulocytopenia with cisplatin. Increased risk of neurotoxicity with paclitaxel, itraconazole, ketoconazole. Increased radiosensitising effects with prior or concomitant radiation therapy. Increased pulmonary toxicity with mitomycin. Increased myelotoxicity with zidovudine. Earlier onset and/or an increased severity of side effects with CYP3A inhibitors. Possible increase in vincristine levels with aprepitant. Possible infection with live vaccines.
","Hypersensitivity to vinorelbine or other vinca alkaloids; severe current or recent infection (within last 2 wk); neutropenia; thrombocytopenia; severe hepatic impairment. Intrathecal admin. Do not give concomitantly with radiotherapy if liver is in treatment field. Pregnancy, lactation.
","Neurotoxicity, peripheral paraesthesia, loss of deep tendon reflexes, abdominal pain, severe constipation, diarrhoea, alopecia, severe local irritation. Dose limiting granulocytopenia, leukopenia and anaemia. Intestinal obstruction, paralytic ileus, nausea, vomitinh, increased in LFT, chest pain, fatigue. Local pain and thrombophlebitis with repeated Inj.
","Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Hepatic impairment. Compromised bone marrow reserve due to prior irradiation or chemotherapy; recovering marrow function from the effects of previous chemotherapy. Prior radiation therapy; past history or pre-existing neuropathy. CBC with differentials to be monitored prior to admin of subsequent doses. Delay subsequent doses, if neutrophil count < 2000 cells/mm3. Each admin to be followed by at least 250 ml of normal saline to flush the vein. Avoid extravasation. If extravasation occurs, stop infusion immediately, and flush the vein with normal saline solution; admin the remaining solution in another vein. Do not father a child during and up to six mth after treatment and females of childbearing potential to use effective method of contraception during treatment and three mth thereafter. When admin orally, capsules must be swallowed whole with water and not chewed or sucked.
","Hepatic Impairment:
Intravenous:
+
+- Cervical cancer: Dose adjustments may be needed.
+- Breast cancer, Ovarian cancer: Dose adjustments may be needed.
+- Non-small cell lung cancer: Massive liver metastases(>75% of liver volume replaced by the tumour): Decrease dose by 1/3. Bilirubin 2.1-3 mg/100 ml: Reduce IV dose by 50%. Bilirubin >3 mg/100 ml: Reduce IV dose by 75%.
+
+Oral:
+
+- Massive liver metastases(>75% of liver volume replaced by the tumour): Decrease dose by 1/3. Bilirubin 2.1-3 mg/100 ml: Reduce IV dose by 50%. Bilirubin >3 mg/100 ml: Reduce IV dose by 75%.
+
",,,,"Intravenous: Store at 2-8°C. Protect from light. Oral: Store at 2-8°C.
",11
+1127,Vincristine Sulfate,vincristine-sulfate-1127,https://medex.com.bd/attachments/cV8JL68pj8uEeJoWs0FW1x4XtFED94/vincristine-sulfate-prescribing-information,Cytotoxic Chemotherapy,Wilm's tumour,"Vincristine sulfate injection is indicated in acute leukemia. Vincristine sulfate injection has also been shown to be useful in combination with other oncolytic agents in Hodgkin's disease, non-Hodgkin's malignant lymphomas (lymphocytic, mixed cell, histiocytic, undifferentiated, nodular and diffuse types), rhabdomyosarcoma, neuroblastoma, and Wilms' tumor.
","Cytotoxic Chemotherapy
","Vincristine arrests cell division at the metaphase stage by inhibiting microtubule formation in the mitotic spindle.
","Adult (Intravenous): Usual recommended dosage: 1.4-1.5 mg/m2 once wkly. Max: 2 mg wkly. Subsequent doses may be modified based on clinical and haematological responses and tolerance of the patient. May be used in combination with other drugs. Prescribers should consult published protocols for the dosage, method and sequence of admin.
Child (Intravenous): Usual recommended dosage: 1.5-2 mg/m2 once wkly; for patients ≤10 kg: Initiate at 0.05 mg/kg once wkly. Subsequent doses may be modified based on clinical and haematological responses and tolerance of the patient. May be used in combination with other drugs. Prescribers should consult published protocols for the dosage, method and sequence of admin.
",,"Decreased digoxin (tablets) and verapamil absorption with antineoplastic regimens. Increased etoposide serum levels with vincristine. Increased toxicity when ganciclovir given with, immediately before or after vincristine. Reduced vincristine metabolism with miconazole. Increased neurotoxicity with isoniazid, itraconazole, voriconazole, posaconazole and nifedipine. Decreased immune response when used concurrently with vaccines. Increased myelotoxicity with zidovudine. Increased risk of thromboembolic complications with tamoxifen. Increased risk of ototoxicity with ototoxic drugs (e.g. platinum-containing antineoplastic agents). Possible risk of earlier onset and/or increased severity of adverse effects with macrolides. Possible increase in vincristine levels with aprepitant. Possible decrease in antiepileptic levels with vincristine, monitor serum antiepileptic levels and effectiveness of chemotherapy.
","Patients with demyelinating form of Charcot-Marie-Tooth syndrome. Pregnancy and lactation. Intrathecal admin (may be fatal). Patients receiving radiation therapy through ports which include liver.
","Dose limiting neurotoxicity (e.g. motor function impairment, gait abnormalities), hyperuricaemia, bronchospasm, azospermia, amenorrhoea, alopoecia, leucopenia, urinary dysfunction, abdominal cramps, vomiting, diarrhoea, severe constipation, paralytic ileus, convulsions, hypertension, orthostatic hypotension, ptosis, hoarseness, optic neuropathies, hallucinations, blindness, neurological deafness, difficulty in walking, syndrome of inappropriate ADH secretion.
","Pregnancy Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Elderly. Preexisting pulmonary dysfunction or neuromuscular disease; leucopenia or a complicating infection; impaired liver function; obstructive jaundice. Routine prophylactic laxative needed to ensure regular bowel movement. Discontinue immediately if extravasation occurs, and inj any remaining drug into another vein, followed by local Inj of hyaluronidase and topical heat application to the affected area to aid in drug removal and reduce discomfort. Discontinue in patients who develop progressive dyspnea. CBC to be checked before each dose admin. Frequent monitoring of uric acid during first 3-4 wk of treatment and watch out for uric acid nephropathy.
","Hepatic Impairment: Dose adjustment may be needed. Serum bilirubin >3 mg/100ml: Reduce dose by 50%.
","Symptoms: mainly extensions of its common adverse effects.
Management: Treatment is supportive and includes prevention of side effects from syndrome of inappropriate antidiuretic hormone secretion (SIADH) (e.g. fluid restriction and admin of loop diuretic); admin of anticonvulsants and use of enemas (to prevent ileus). Closely monitor the CV system and determine the blood counts daily to guide transfusion requirements. Folinic acid 100 mg admin IV every 3 hr for 24 hr and then every 6 hr for at least 48 h may be admin. Haemodialysis unlikely to be useful.
",,,"Store at 2-8° C. Protect from light.
",12
+1126,Vinblastine Sulfate,vinblastine-sulfate-1126,https://medex.com.bd/attachments/XSYu9GEXmZK94GURqdD6Hz0dWzsWfc/vinblastine-sulfate-prescribing-information,Cytotoxic Chemotherapy,Testicular cancer,"Vinblastine is effective as a single agent, but its therapeutic effect is enhanced when used in combination with other antineoplastic drugs. Vinblastine has been used in the treatment of Hodgkin’s disease (Stages III and IV) in combination therapy (with adriamycin (doxorubicin), bleomycin and ... Read more
Vinblastine is effective as a single agent, but its therapeutic effect is enhanced when used in combination with other antineoplastic drugs. Vinblastine has been used in the treatment of Hodgkin’s disease (Stages III and IV) in combination therapy (with adriamycin (doxorubicin), bleomycin and dacarbazine as ABVD) and in the treatment of advanced testicular carcinoma (with cisplatin and bleomycin). Vinblastine has been used in the palliative treatment of lymphocytic lymphoma, histiocytic lymphoma, advanced stages of mycosis fungoides, Kaposi's sarcoma and Histiocytosis X.
Vinblastine may be used in the treatment of choriocarcinoma resistant to other chemotherapeutic agents; carcinoma of the breast, unresponsive to appropriate endocrine surgery and hormonal therapy. One of the most effective single agents for treatment of Hodgkin’s disease is vinblastine. A protocol substituting cyclophosphamide for nitrogen mustard and vinblastine for vincristine in MOPP is an alternative therapy for previously untreated patients with advanced Hodgkin’s disease. Patients suffering relapse have also responded to combination therapy that included vinblastine. Advanced testicular germ-cell cancers are sensitive to vinblastine alone but the administration of vinblastine concomitantly with other antineoplastic agents, produces better clinical results. Bleomycin effectiveness is enhanced when vinblastine is administered 6 to 8 hours prior to bleomycin administration; this schedule permits more cells to be arrested during metaphase, in which bleomycin is active.
","Cytotoxic Chemotherapy
","Vinblastine is M phase specific. It binds to microtubular proteins and arrests mitosis at the metaphase by disrupting mitotic spindle formation. It blocks glutamic acid utilization, thus inhibiting purine synthesis, the citric acid cycle, and the formation of urea. It may also interfere with nucleic acid and protein synthesis.
","Adult (Intravenous): Initially, 3.7 mg/m2, increase dose wkly based on WBC counts in increments of about 1.8 mg/m2 until leukocyte count decreases to about 3000/mm3, or max wkly dose of 18.5 mg/m2 reached. Do not increase dose if leukocyte count is reduced to approximately 3000 cells/mm3; administer the max dose that does not cause leucopenia for maintenance. Do not increase subsequent doses if onolytic activity occurs before leucopenic effect. Usual dose: 5.5-7.4 mg/m2 per wk. Do not admin next dose, even though 7 days have lapsed unless the leukocyte count has returned to at least 4000/mm3.
Child (Intravenous): Initial 2.5 mg/m2 of BSA, increased dose at wkly intervals in increments of about 1.25 mg/m2 until leukocyte count decreases to about 3000/ mm3, or max wkly dose of 12.5 mg/m2 reached. Do not increase dose once leukocyte count reaches approximately 3000 cells/mm3, instead, a dose of 1 increment smaller to be admin at wkly intervals for maintenance i.e. patient receives the max dose that does not cause leucopenia. If onolytic activity is encountered before leucopenic effect, then there is no need to increase subsequent doses. Do not admin next dose, even though 7 days have lapsed unless the leukocyte count has returned to at least 4000/mm3. Duration of maintenance therapy depends on disease state and the antineoplastic agent combination.
",,"Possible increase in vinblastine levels with aprepitant. Reduced vinblastine metabolism with miconazole. Variable interactions with phenytoin, monitor serum phenytoin levels. Reduced immune response with vaccines. Additive myelotoxicity with zidovudine. Concurrent admin of vinblastine with CYP3A inhibitors may cause an earlier onset and/or an increased severity of side effects.
","Severe bone marrow suppression; presence of bacterial infection; maglignant cell infiltration of bone marrow; Inj into extremity with poor circulation; porphyria; granulocytopenia. Elderly with cachexia or extreme skin ulcerations. Pregnancy; lactation. Intrathecal use may result in death.
","Alopecia, constipation, malaise, stomatitis, dose-limiting bone marrow suppression (e.g. granulocytopenia, thrombocytopenia, anaemia), hypertension, central and peripheral neurotoxicity, 8th cranial nerve damage resulting in vestibular and auditory toxicity, ischaemic cardiac toxicity, breathlessness, bone, tumour or jaw pain. Nausea, vomiting, GI bleed, syndrome of inappropriate antidiuretic hormone. Necrosis, cellulitis if extravasation occurs.
","Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
","Hepatic impairment; neurotoxicity; ischemic heart disease; preexisting pulmonary dysfunction; extravasation may cause tissue damage and pain. Discontinue immediately if extravasation occurs, with local Inj of hyaluronidase and local heat application to decrease discomfort and risk of cellulitis; remaining Inj to be injected into another vein. Routine prophylaxis against constipation recommended especially in high doses. Nadir in leukocyte count occur 4-10 days after vinblastine admin; recovery observed 7-14 days after treatment.
","Hepatic Impairment: Serum bilirubin >3 mg/100ml: Reduce dose by 50%.
","Symptoms: Severe bone marrow suppression and extensions of its usual side effects.
Management: Treatment is supportive. Restrict fluid and use of loop diuretics to counteract the effects of syndrome of inappropriate secretion of antidiuretic hormone. Monitor the patient's CV system and daily blood counts for transfusion requirement.
",,,"Store at 2-8° C.
",12
+738,Vildagliptin + Metformin Hydrochloride,vildagliptin-metformin-hydrochloride-738,https://medex.com.bd/attachments/71FcnBNCyVpEUgwfapd2nCcyZBpceA/vildagliptin-metformin-hydrochloride-prescribing-information,Combination Oral hypoglycemic preparations,Type 2 DM,"This tablet is indicated as an adjunct to diet and exercises to improve glycaemic control in patients with type 2 diabetes mellitus whose diabetes is not adequately controlled on Metformin Hydrochloride or Vildagliptin alone or who are already treated with the combination of Vildagliptin and Metformin Hydrochloride, as separate tablets.
","Combination Oral hypoglycemic preparations
","Vildagliptin acts primarily by inhibiting DPP-4 (Dipeptidyl peptidase-4), the enzyme responsible for the degradation of the incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide). The administration of Vildagliptin results in a rapid and complete inhibition of DPP-4 activity resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 and GIP. By increasing the endogenous levels of these incretin hormones, Vildagliptin increases insulin secretion from the pancreatic beta cell and decreases glucagon secretion from alpha cell. The enhanced increase in the insulin/glucagon ratio during hyperglycaemia due to increased incretin hormone levels results in a decrease in fasting and postprandial hepatic glucose production, leading to reduced glycaemia.
Metformin Hydrochloride is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Glucomin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
","Adults: Based on the patient's current dose of Metformin, this combination may be initiated at twice daily, 1 tablet in the morning and the other in the evening. Patients receiving Vildagliptin and Metformin from separate tablets may be switched to this combination containing the same doses of each component. Doses higher than 100 mg of vildagliptin are not recommended. There is no clinical experience of Vildagliptin and Metformin in triple combination with other antidiabetic agents. Taking this combination with or just after food may reduce gastrointestinal symptoms associated with Metformin.
",,"No clinically relevant pharmacokinetic interaction was observed when Vildagliptin (100 mg once daily) was co-administered with Metformin Hydrochloride (1,000 mg once daily). Vildagliptin has a low potential for drug interactions. Since Vildagliptin is not a cytochrome P (CYP) 450 enzyme substrate nor does it inhibit nor induces CYP 450 enzymes, it is not likely to interact with co-medications that are substrates, inhibitors or inducers of these enzymes. As a result of these studies no clinically relevant interactions with other oral antidiabetics (glibenclamide, pioglitazone, metformin hydrochloride), amlodipine, digoxin, ramipril, simvastatin, valsartan or warfarin were observed after co-administration with vildagliptin. On the other hand, furosemide, nifedipine and glyburide increase Cmax and blood AUC of Metformin with no change in renal clearance of Metformin.
","This combination is contraindicated in patients with known hypersensitivity to Vildagliptin or Metformin Hydrochloride or to any of the excipients. It is contraindicated in patients with renal disease or renal dysfunction, acute myocardial infarction, and septicaemia. It is also contraindicated in patients with congestive heart failure patients and in patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. It should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function.
","The most common side effects are headache, tremor, dizziness, nausea, hypoglycaemia etc.
","There are no adequate and well controlled studies in pregnant women and therefore, this combination should not be used during pregnancy unless the potential benefit justifies the potential risk to the foetus. No studies have been conducted with the components of this combination. As it is not known whether Vildagliptin and/or Metformin Hydrochloride is excreted in human milk this combination should not be administered to breast-feeding women.
","Lactic acidosis can occur due to Metformin accumulation. If metabolic acidosis is suspected, treatment should be discontinued and the patient should be hospitalized immediately. Serum creatinine should be monitored at least once a year in patients with normal renal function and 2–4 times a year in patients with serum creatinine levels at the upper limit of normal and in elderly patients. Special caution should be exercised in elderly patients where renal function may become impaired (e.g. when initiating antihypertensives, diuretics or NSAIDs). It is recommended that Liver Function Tests (LFTs) are monitored prior to initiation of this drug, at three-monthly intervals in the first year and periodically thereafter. If transaminase levels are increased, patients should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent liver function tests until the abnormality return to normal. If AST or ALT persist at 3 x ULN, Vildagliptin & Metformin tablets should be stopped Patients who develop jaundice or other signs of liver dysfunction. Following withdrawal of treatment with Vildagliptin & Metformin and LFT normalization, treatment with Vildagliptin & Metformin should not be reinitiated. Vildagliptin & Metformin tablets should be discontinued 48 hours before elective surgery with general anaesthesia and should not usually be resumed earlier than 48 hours afterwards.
","Use in pediatric patients: The safety and effectiveness of this combination in pediatric patients have not been established. Therefore, this combination is not recommended for use in children below 18 years of age.
Use in geriatric patients: As Metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking this combination should have their renal function monitored regularly. This combination should only be used in elderly patients with normal renal function.
Patients with renal impairment: This combination should not be used in patients with renal failure or renal dysfunction, e.g. serum creatinine levels > 1.5 mg/dl (>135 micro mol/L) in males and > 1.4 mg/dl (>110 micro mol/L) in females.
Patients with hepatic impairment: This combination is not recommended in patients with hepatic impairment including patients with a pre-treatment ALT or AST >3 X the upper limit of normal.
",,,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",11
+1125,Vildagliptin,vildagliptin-1125,https://medex.com.bd/attachments/7qlijQ5FMdoffCXaVVsh7d18dnEcad/vildagliptin-prescribing-information,Dipeptidyl Peptidase-4 (DPP-4) inhibitor,Type 2 DM,"Vildagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus as monotherapy and in dual combination with Metformin, a Sulphonylurea, a Thiazolidinedione, or Insulin when diet, exercise and a single antidiabetic agent do not result in adequate glycemic control.
","Dipeptidyl Peptidase-4 (DPP-4) inhibitor
","Vildagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, which is believed to exert its actions in patients with type 2 diabetes by slowing the inactivation of incretin hormones. Incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the intestine throughout the day, and levels are increased in response to a meal. These hormones are rapidly inactivated by the enzyme, DPP-4. The incretins are part of an endogenous system involved in the physiologic regulation of glucose homeostasis. When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells by intracellular signaling pathways involving cyclic AMP. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, leading to reduced hepatic glucose production. By increasing and prolonging active incretin levels, Vildagliptin increases insulin release and decreases glucagon levels in the circulation in a glucose-dependent manner.
","The recommended dose of Vildagliptin is-
+
+- 50 mg or 100 mg daily for monotherapy.
+- 50 mg twice daily (morning and evening) when used in dual combination with Metformin or a Thiazolidinedione;
+- 50 mg once daily in the morning when used in dual combination with a Sulphonylurea.
+
+Vildagliptin may be taken with or without a meal. No dosage adjustment is required in the elderly, or in patients with mild renal impairment.
Pediatric use: Vildagliptin is not recommended in patients 18 years of age.
",,"In pharmacokinetic studies, no interactions were seen with pioglitazone, metformin, glibenclamide, digoxin, warfarin, amlodipine, ramipril, valsartan or simvastatin. As with other oral antidiabetic medicinal products the glucose-lowering effect of Vildagliptin may be reduced by certain active substances, including thiazides, corticosteroids, thyroid products and sympathomimetics.
","Vildagliptin is contraindicated in patients with:
+
+- Hypersensitivity to the active substance or to any of the excipients
+- Patients with moderate to severe renalImpairment
+- Patients with Hepatic Impairment: patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotrasferase (AST) >3 times the upper limit of normal (ULN).
+- Patients with type 1 diabetes
+
","The majority of adverse reactions were mild and transient, not requiring treatment discontinuations. A rare case of hepatic dysfunction is seen. Clinical trials of up to and more than 2 years duration did not show any additional safety signals or unforeseen risks when using this combination.
","Vildagliptin should not be used in pregnancy. Vildagliptin should not be used during lactation.
","Caution should be exercised in patients aged 75 years and older due to limited clinical experience. It is recommended that LFTs are monitored prior to initiation of Vildagliptin, at three-monthly intervals in the first year and periodically thereafter. If transaminase levels are increased, patients should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent liver function tests until the abnormality returns to normal. If AST or ALT persists at 3xULN, Vildagliptin treatment should be stopped. Patients who develop jaundice or other signs of liver dysfunction should discontinue Vildagliptin. Following the withdrawal of treatment with Vildagliptin and LFT normalization, treatment with Vildagliptin should not be reinitiated. Due to limited clinical experience, use with caution in patients with congestive heart failure of New York Heart Association (NYHA) functional class I-II, and do not use in patients with NYHA functional class III IV.
",,,,,"Store below 30°C temperature & keep away from light & moisture. Keep out of reach of children.
",10
+2068,Vilazodone Hydrochloride,vilazodone-hydrochloride-2068,https://medex.com.bd/attachments/5PO36035quSFe6N0x1UL0Oiu4II4y5/vilazodone-hydrochloride-prescribing-information,Atypical anti-depressant drugs,Major depressive disorder,"Vilazodone Hydrochloride is indicated for the treatment of major depressive disorder (MDD) in adults.
","Atypical anti-depressant drugs
","The mechanism of action of vilazodone in the treatment of major depressive disorder is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS through selective inhibition of serotonin reuptake. Vilazodone is also a partial agonist at serotonergic 5-HT1A receptors; however, the net result of this action on serotonergic transmission and its role in vilazodone’s antidepressant effect are unknown.
","Dosage for Treatment of Major Depressive Disorder: The recommended target dosage for vilazodone is 20 mg to 40 mg orally once daily with food. To achieve the target dosage, titrate vilazodone as follows:
+
+- Start with an initial dosage of 10 mg once daily with food for 7 days,
+- Then increase to 20 mg once daily with food.
+- The dose may be increased up to 40 mg once daily with food after a minimum of 7 days between dosage increases.
+
+If a dose is missed, it should be taken as soon as the patient remembers. If it is almost time for the next dose, the patient should skip the missed dose and take the next dose at the regular time. Two doses should not be taken at the same time.
Screen for Bipolar Disorder Prior to Starting vilazodone: Prior to initiating treatment with vilazodone or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania.
Switching to or from a Monoamine Oxidase Inhibitor Antidepressant: At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of vilazodone. In addition, at least 14 days must elapse after stopping vilazodone before starting an MAOI antidepressant.
Dosage Adjustments with CYP3A4 Inhibitors or Inducers:
+
+- Patients receiving concomitant CYP3A4 inhibitors: During concomitant use of a strong CYP3A4 inhibitor (e.g., itraconazole, clarithromycin, voriconazole), the vilazodone dose should not exceed 20 mg once daily. The original vilazodone dose level, can be resumed when the CYP3A4 inhibitor is discontinued.
+- Patients receiving concomitant CYP3A4 inducers: Based on clinical response, consider increasing the dosage of vilazodone by 2-fold, up to a maximum 80 mg once daily, over 1 to 2 weeks in patients taking strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin) for greater than 14 days. If CYP3A4 inducers are discontinued, gradually reduce the vilazodone dosage to its original level over 1 to 2 weeks.
+
+
Discontinuing Treatment with vilazodone: Adverse reactions may occur upon discontinuation of vilazodone. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible. vilazodone should be down tapered from the 40 mg once daily dose to 20 mg once daily for 4 days, followed by 10 mg once daily for 3 days. Patients taking vilazodone 20 mg once daily should be tapered to 10 mg once daily for 7 days.
",,"CYP3A4 Inhibitors: The vilazodone dose should not exceed 20 mg once daily when coadministered with strong CYP3A4 inhibitors.
CYP3A4 Inducers: Consider increasing vilazodone dosage by 2-fold, up to 80 mg once-daily over 1 to 2 weeks when used concomitantly with strong CYP3A4 inducers for greater than 14 days).
","Vilazodone is contraindicated in patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome.
","
+- Suicidal Thoughts and Behaviors in Adolescents and Young Adults
+- Serotonin Syndrome
+- Increased Risk of Bleeding
+- Activation of Mania or Hypomania
+- Discontinuation Syndrome
+- Seizures
+- Angle-Closure Glaucoma
+- Hyponatremia
+- Sexual Dysfunction
+
","There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. There are no data on the presence of vilazodone in human milk, the effects of vilazodone on the breastfed infant, or the effects of the drug on milk production.
","Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans, amphetamines), but also when taken alone. If it occurs, discontinue vilazodone and initiate supportive treatment.
Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk.
Activation of Mania/Hypomania: Screen patients for bipolar disorder.
Seizures: Can occur with treatment. Use with caution in patients with a seizure disorder.
Angle Closure Glaucoma: Avoid use of antidepressants, including vilazodone, in patients with untreated anatomically narrow angles.
Sexual Dysfunction: vilazodone may cause symptoms of sexual dysfunction.
","Pediatric Use: The safety and effectiveness of Vilazodone have not been established in pediatric patients for the treatment of MDD.
Geriatric Use: Based on a pharmacokinetic study, no dosage adjustment of Vilazodone is recommended on the basis of age. Results from pharmacokinetic study of a single 20 mg Vilazodone dose in geriatric subjects (>65 years-old) vs. younger subjects (24-55 years-old) demonstrated that the pharmacokinetics were generally similar between the two age groups.
",,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",11
+1977,Vilanterol Trifenatate + Fluticasone Furoate,vilanterol-trifenatate-fluticasone-furoate-1977,https://medex.com.bd/attachments/JBGMUOm0gzw101cSfgTPjGBsHGKTG2/vilanterol-trifenatate-fluticasone-furoate-prescribing-information,Respiratory corticosteroids,COPD,"This is indicated in-
+
+- Long-term, once-daily, maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).
+- Once-daily treatment of asthma in patients aged 18 years and older.
+
","Respiratory corticosteroids
","This preparation contains both futicasone furoate and vilanterol, the mechanisms of action described below for the individual components. These drugs represent 2 diferent classes of medications (a synthetic corticosteroid and a LABA) that have diferent efects on clinical and physiological aspects. The pharmacologic efects of beta 2-adrenoceptor agonist drugs, including vilanterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3, 5-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells. The precise mechanism through which futicasone furoate afects COPD and asthma symptoms is not known. Infammation is an important component in the pathogenesis of COPD and asthma. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in infammation.
","Should be administered as 1 inhalation once daily by the orally inhaled route only.
+
+- For COPD: 100 micrograms cozycap: 1 inhalation once daily. Should be taken by revolizer.
+- For Asthma: 100 micrograms or 200 micrograms cozycap: 1 inhalation once daily. The maximum recommended dosage of 200 micrograms cozycap: 1 inhalation once daily. Should be taken by revolizer.
+
",,"
+- Other adrenergic drugs may potentiate efect. Use with caution.
+- Xanthine derivatives, steroids, diuretics or non-potassium sparing diuretics may potentiate hypokalemia or EDG changes. Use with caution.
+- Diuretics: Use with caution.
+- Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate the effect of formoterol fumarate on cardiovascular system.
+- Beta-Blockers: Use with caution and only when medically necessary.
+- Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administrations of Beviprex with other anticholinergic-containing drugs.
+
","
+- Primary treatment of status asthmaticus or acute episodes of COPD or asthma requiring intensive measures.
+- Severe hypersensitivity to milk proteins or any ingredients.
+- Hypersensitivity to the active substances or to any of the excipients.
+- LABA monotherapy increases the risk of serious asthma-related events.
+- Do not initiate in acutely deteriorating COPD or asthma. Do not use to treat acute symptoms.
+- Do not use in combination with an additional medicine containing a LABA because of risk of overdose.
+
","Common side efects in COPD: Most common adverse reactions (incidence ≥3%) are nasopharyngitis, upper respiratory tract infection, headache, oral candidiasis, back pain, pneumonia, bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia, hypertension, infuenza, pharyngitis, and pyrexia.
Common side efects in Asthma: Most common adverse reactions (incidence ≥2%) are nasopharyngitis, oral candidiasis, headache, infuenza, upper respiratory tract infection, bronchitis, sinusitis, oropharyngeal pain, dysphonia, and cough.
","Insufficient data on the use of this preparation in pregnant women and lactating mothers.
","
+- Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk.
+- Increased risk of pneumonia in patients with COPD. Monitor patients for signs and symptoms of pneumonia.
+- Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infections; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
+
","Elderly population: It can be used at the recommended dose in elderly patients.
Renal impairment: No dosage adjustment is required in patients with renal impairment.
Hepatic impairment: Caution should be observed in patients with moderate or severe hepatic impairment.
Pediatric population: The safety and efficacy of this combination in children have not been established. No data are available.
",,,,"Store below 25°C. Protect from light & moisture. Keep out of the reach of children.
",11
+1978,Vilanterol + Umeclidinium + Fluticasone Furoate,vilanterol-umeclidinium-fluticasone-furoate-1978,https://medex.com.bd/attachments/lJzf1S6XxkTbSeEuxR0GhpHe5gSXbV/vilanterol-umeclidinium-fluticasone-furoate-prescribing-information,Combined bronchodilators,COPD,"This is indicated in-
+
+- For the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
+- For the maintenance treatment of asthma in patients aged 18 years and older.
+
","Combined bronchodilators
","This cozycap is an inhalation powder drug product for delivery of a combination of futicasone furoate (an ICS), umeclidinium (an anticholinergic), and vilanterol (a LABA) to patients by oral inhalation. The pharmacologic efects of beta 2-adrenoceptor agonist drugs, including vilanterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3, 5 -adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
The precise mechanism through which futicasone furoate afects COPD and asthma symptoms is not known. Infammation is an important component in the pathogenesis of COPD and asthma. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in infammation.
Umeclidinium is a long-acting muscarinic antagonist, which is often referred to as an anticholinergic. It has similar afnity to the subtypes of muscarinic receptors M1 to M5 . In the airways, it exhibits pharmacological efects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation.
","Adults: 18 years or older: For oral inhalation only. Should be taken by revolizer. Should be used at the same time every day, not more than 1 time every 24 hours. If shortness of breath or other asthma symptoms arise in the period between doses, an inhaled SABA should be taken for immediate relief.
+
+- Maintenance treatment of COPD: 1 inhalation of cozycap once daily.
+- Maintenance treatment of asthma: 1 inhalation of cozycap once daily.
+- Limitation of use: Not indicated for relief of acute bronchospasm.
+
",,"
+- Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. May cause systemic corticosteroid and cardiovascular effects.
+- Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate the effect of vilanterol on the vascular system.
+- Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm.
+- Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non–potassium-sparing diuretics may worsen with concomitant beta-agonists.
+- Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administration of this preparation with other anticholinergic-containing drugs.
+
","
+- Primary treatment of status asthmaticus or acute episodes of COPD or asthma requiring intensive measures
+- Severe hypersensitivity to milk proteins or any ingredients.
+
","COPD: Most common adverse reactions (incidence ≥1%) are upper respiratory tract infection, pneumonia, bronchitis, oral candidiasis, headache, back pain, arthralgia, infuenza, sinusitis, pharyngitis, rhinitis, dysgeusia, constipation, urinary tract infection, diarrhea, gastroenteritis, oropharyngeal pain, cough, and dysphonia.
Asthma: Most common adverse reactions (incidence ≥2%) are pharyngitis/nasopharyngitis, upper respiratory tract infection/viral upper respiratory tract infection, bronchitis, respiratory tract infection/viral respiratory tract infection, sinusitis/acute sinusitis, urinary tract infection, rhinitis, infuenza, headache, and back pain.
","Insufficient data on the use of this preparation in pregnant women and lactating mothers.
","
+- LABA monotherapy increases the risk of serious asthma-related events.
+- Do not initiate in acutely deteriorating COPD or asthma. Do not use to treat acute symptoms.
+- Do not use in combination with additional therapy containing a LABA because of risk of overdose.
+- Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk.
+- Increased risk of pneumonia in patients with COPD. Monitor patients for signs and symptoms of pneumonia.
+- If paradoxical bronchospasm occurs, discontinue and institute alternative therapy.
+- Use with caution in patients with cardiovascular disorders because of beta-adrenergic stimulation.
+- Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction.
+- Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.
+
","Elderly population: Based on available data, no adjustment of the dosage in geriatric patients is necessary, but greater sensitivity in some older individuals cannot be ruled out.
Renal impairment: It has not been studied in subjects with renal impairment.
Hepatic impairment: It has not been studied in subjects with hepatic impairment.
Pediatric population: It is not indicated for use in children and adolescents. The safety and efficacy in pediatric patients (aged 17 years and younger) have not been established.
",,,,"Store below 25°C, protect from light & moisture. Keep out of reach of children.
",11
+1155,Verteporfin,verteporfin-1155,https://medex.com.bd/attachments/wy8gsIHUahqwYlflT9m2E1q5Af6zyr/verteporfin-prescribing-information,Drugs for Age-Related Macular Degeneration (AMD),Neovascular age-related macular degeneration,"Verteporfin therapy is indicated for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis.
There is insufficient evidence to indicate Verteporfin for the treatment of predominantly occult subfoveal choroidal neovascularization.
","Drugs for Age-Related Macular Degeneration (AMD)
","Verteporfm, when activated by low-intensity nonheat-generating laser light at a wavelength corresponding to its absorption peak, generates highly reactive, shortlived singlet 02 and reactive 02 radicals that cause local damage to neovascular endothelium, resulting in vessel occlusion. It appears to accumulate preferentially in the neovasculature e.g. choroidal neovasculature.
","A course of verteporfin therapy is a two-step process requiring administration of both drug and light. The first step is the intravenous infusion of Verteporfin. The second step is the activation of Verteporfin with light from a nonthermal diode laser. The physician should reevaluate the patient 3 months after treatment and if choroidal neovascular leakage is detected on fluorescein angiography, therapy may be repeated.
Lesion Size Determination: The greatest linear dimension (GLD) of the lesion should be estimated by fluorescein angiography and color fundus photography. All classic and occult CNV, blood and/or blocked fluorescence, and any serous detachments of the retinal pigment epithelium should be included for this measurement. Fundus cameras with magnification within the range of 2.4-2.6X are recommended. The GLD of the lesion on the fluorescein angiogram must be corrected for the magnification of the fundus camera to obtain the GLD of the lesion on the retina.
Spot Size Determination: The treatment spot size should be 1000 microns larger than the GLD of the lesion on the retina to allow a 500 micron border, ensuring full coverage of the lesion. The maximum spot size used in the clinical trials was 6400 microns.
The nasal edge of the treatment spot must be positioned at least 200 microns from the temporal edge of the optic disc, even if this will result in lack of photoactivation of CNV within 200 microns of the optic nerve.
",,"Increased rate of verteporfm uptake by the vascular endothelium with calcium channel blockers, polymyxin B or radiation therapy. Increased photosensitivity with photosensitizing agents (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycaemic agents, thiazide diuretics and griseofulvin). Decreased verteporfm efficacy with compounds that quench active oxygen species or scavenge radicals e.g. dimethyl sulfoxide, betacarotene, ethanol, formate and mannitol. Decreased verteporfm efficacy with drugs that decrease clotting, vasoconstriction or platelet aggregation e.g. thromboxane A2 inhibitors. Anaesthetics may cause haemodynamic effects.
","Verteporfin is contraindicated for patients with porphyria or a known hypersensitivity to any component of this preparation
","Visual disturbances; severe vision loss with or without subretinal or vitreous bleeding; inj site reactions; nausea; photosensitivity; asthenia; cataracts; blepharitis; conjunctivitis; dry eyes; ocular itching; flu-like syndrome; atrial fibrillation; hypertension; peripheral vascular disorder; varicose veins; eczema; constipation; Gl cancers; fever; lachrymation disorder; hypersensitivity reactions; increased LFT.
","Pregnancy Category- C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","Moderate to severe hepatic disorders; biliary disorders. Pregnancy. Use the largest arm vein possible (e.g. antecubital) especially in elderly and avoid small veins in the back of the hand. Stop infusion if extravasation occurs and protect extravasation area from direct light and apply cold compresses. Patient to be under close monitoring during verteporfm infusion and exercise caution when general anaesthesia is considered. Avoid exposure of unprotected skin, eyes or other body organs to direct sunlight or bright indoor light for 5 days after treatment. Protect all parts of skin and eyes by wearing protective clothing and dark sunglasses (sunscreens are ineffective) if going outdoors in daylight is necessary. Exposure to ambient indoor light is encouraged as it helps in gradual inactivation of any remaining drug.
","Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: Approximately 90% of the patients treated with Verteporfin in the clinical efficacy trials were over the age of 65. A reduced treatment effect was seen with increasing age.
","Overdose of drug and/or light in the treated eye may result in non-perfusion of normal retinal vessels with the possibility of severe decrease in vision that could be permanent. An overdose of drug will also result in the prolongation of the period during which the patient remains photosensitive to bright light. In such cases, it is recommended to extend the photosensitivity precautions for a time proportional to the overdose.
",,,,11
+2047,Vericiguat,vericiguat-2047,https://medex.com.bd/attachments/qZ6f9UBzQwEGAUZx2UQnF81OHMoxNJ/vericiguat-prescribing-information,Stimulator of soluble guanylate cyclase,Cardiovascular disease,"Vericiguat is indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%.
","Stimulator of soluble guanylate cyclase
","Vericiguat is a stimulator of soluble guanylate cyclase (sGC), an important enzyme in the nitric oxide (NO) signaling pathway. When NO binds to sGC, the enzyme catalyzes the synthesis of intracellular cyclic guanosine monophosphate (cGMP), a second messenger that plays a role in the regulation of vascular tone, and cardiac contractility, and cardiac remodeling. Heart failure is associated with impaired synthesis of NO and decreased activity of sGC, which may contribute to myocardial and vascular dysfunction. By directly stimulating sGC, independently of and synergistically with NO, vericiguat augments levels of intracellular cGMP, leading to smooth muscle relaxation and vasodilation.
","Recommended Dosage: The recommended starting dose of Vericiguat is 2.5 mg orally once daily with food. Double the dose of Vericiguat approximately every 2 weeks to reach the target maintenance dose of 10 mg once daily, as tolerated by the patient. For patients who are unable to swallow whole tablets, Vericiguat may be crushed and mixed with water immediately before administration.
Pregnancy Testing in Females of Reproductive Potential: Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with Vericiguat.
Pediatric Use: Safety and effectiveness of Vericiguat have not been established in pediatric patients.
",,"Other Soluble Guanylate Cyclase Stimulators: Vericiguat is contraindicated in patients with concomitant use of another soluble guanylate cyclase (sGC) stimulator.
PDE-5 Inhibitors: Concomitant use of Vericiguat with PDE-5 inhibitors is not recommended because of the potential for hypotension.
","Vericiguat is contraindicated in patients with concomitant use of another soluble guanylate cyclase (sGC) stimulator. Vericiguat is contraindicated in pregnancy.
",,"Based on data from animal reproduction studies, Vericiguat may cause fetal harm when administered to a pregnant woman and is contraindicated during pregnancy. There are no data on the presence of vericiguat in human milk, the effects on the breastfed infant, or the effects on milk production. Vericiguat is present in the milk of lactating rats and it is likely that vericiguat or its metabolites are present in human milk. Because of the potential for serious adverse reactions in breastfed infants from Vericiguat, advise women not to breastfeed during treatment with Vericiguat.
","Based on data from animal reproduction studies, Vericiguat may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Obtain a pregnancy test before the start of treatment. Advise females of reproductive potential to use effective contraception during treatment with Vericiguat and for at least one month after the final dose.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+1124,Verapamil Hydrochloride,verapamil-hydrochloride-1124,https://medex.com.bd/attachments/dgygv9n0gKztlDJ29Vkul1sx6Jyq3l/verapamil-hydrochloride-injection-prescribing-information,Calcium-channel blockers,Tachycardia,"Verapamil Tablet:
+
+- Essential hypertension
+- Angina pectoris and prevention of re-infarction
+- Supraventricular arrhythmias
+
+Verapamil Injection:
+
+- Tachycardias such as: Paroxysmal supraventricular tachycardias
+- Atrial fibrillation with rapid ventricular response (except WPWS)
... Read more
Verapamil Tablet:
+
+- Essential hypertension
+- Angina pectoris and prevention of re-infarction
+- Supraventricular arrhythmias
+
+Verapamil Injection:
+
+- Tachycardias such as: Paroxysmal supraventricular tachycardias
+- Atrial fibrillation with rapid ventricular response (except WPWS)
+- Atrial flutter with rapid conduction
+- Extrasystoles
+- Acute hypertension
+- Acute coronary insufficiency
+
+For the prophylaxis and / or therapy of ectopic arrhythmias (predominantly ventricular extrasystoles) in halothane anaesthesia and in the application of adrenaline in halothane anaesthesia respectively.
","Calcium-channel blockers
","Verapamil is an L-type calcium channel blocker with antiarrhythmic, antianginal, and antihypertensive activity. Immediate-release verapamil has a relatively short duration of action, requiring dosing 3 to 4 times daily, but extended-release formulations are available that allow for once-daily dosing. As verapamil is a negative inotropic medication (i.e. it decreases the strength of myocardial contraction), it should not be used in patients with severe left ventricular dysfunction or hypertrophic cardiomyopathy as the decrease in contractility caused by verapamil may increase the risk of exacerbating these pre-existing conditions.
","Verapamil Tablet:
+
+- The dose of Verapamil should be individualized by titration and the drug should be administered with food.
+- For essential hypertension the initial dose should be given 180 mg in the morning. If adequate response is not obtained with 180 mg of Verapamil then the dose may be titrated by following manner: 240 mg each morning. 180 mg each morning plus 180 mg each evening. 240 mg every 12 hourly.
+- For angina the usual dose is 80 mg to 120 mg three times a day.
+- For arrythmias in digitalized patients, Verapamil should be given 240 mg to 360 mg in divided doses, depending on the severity of the condition. Divided doses up to 180 mg/day may occasionally be needed.
+
+
Verapamil Injection:
+
Adults: 5 mg slowly intravenously, in tachycardias and hypertensive crises, if necessary repeat after 5 to 10 minutes. Drip infusion to maintain the therapeutic effect: 5-10 mg/hour in physiological saline, glucose, laevulose or similar solutions, on average up to a total dose of 100 mg/day.
Children:
+
+- Newborn: 0.75-1 mg (0.3-0.4 ml)
+- Infants: 0.75-2 mg (0.3-0.8 ml)
+- Children age 1-5 years: 2-3 mg (0.8-1.2 ml)
+- Age 6-14 years: 2.5-5 mg (1-2 ml)
+
+of Verapamil, given intravenously, depending on age and action. The injection should be made slowly under electrocardiographic control and only until onset of the effect. Intravenous infusion in hypertensive crises: initially 0.05-0.1 mg/kg/hour; if the effect proves to be insufficient, the dose is increased at 30-60 minute intervals until twice the dose or more is reached. Average total dose up to 1.5 mg/kg/day.
",,"May increase plasma level with CYP3A4 inhibitors (e.g. erythromycin, ritonavir), cimetidine. May decrease plasma level with CYP3A4 inducers (e.g. rifampicin), phenobarbital, sulfinpyrazone. Increased risk of bleeding with aspirin. May increase bradycardic and hypotensive effect with telithromycin. Increased AV blocking effect with clonidine. May increase plasma level of cardiac glycosides (e.g. digoxin, digitoxin), β-blockers (e.g. propranolol, metoprolol), α-blockers (e.g. terazosin, prazosin), immunosuppressants (e.g. sirolimus, ciclosporin, tacrolimus, everolimus), lipid lowering agents (e.g. lovastatin, simvastatin, atorvastatin), colchicines, quinidine, carbamazepine, imipramine, glibenclamide, doxorubicin, midazolam, buspirone, almotriptan, theophylline. May potentiate hypotensive effect with diuretics, antihypertensives, vasodilators. May increase neurotoxic effect of lithium.
","
+- Severe left ventricular dysfunction
+- Hypotension or cardiogenic shock
+- Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker)
+- Second or third-degree atrioventricular (AV) block (except in patients with a functioning artificial pacemaker)
+- Patients with atrial flutter or atrial fibrillation and an accessory by pass tract (eg. Wolff-Parkinson-White, Lown-Ganong-Levine syndrome)
+- Patients with known hypersensitivity to verapamil hydrochloride
+
","Verapamil is generally well tolerated. The following reaction to orally administered Verapamil appeared clearly drug-related or occurred at rates greater than 1% in clinical trials with approximately 5000 patients.
+
+- Digestive system: Constipation, nausea;
+- Cardiovascular system: Hypotension, edema, CHF, pulmonary edema, bradycardia, AV block;
+- Respiratory system: Upper respiratory tract infections;
+- Nervous system: Dizziness, headache, fatigue;
+- Skin: Rash, flashing;
+- Hepatic: Elevated liver enzyme.
+
","There are no adequate and well-controlled studies in pregnant women, so this drug should be used during pregnancy only if clearly needed. Verapamil crosses the placental barrier and can be detected in umbilical vein blood during delivery. Verapamil is excreted in breast milk. So nursing should be discontinued while Verapamil is administered.
","Care should be taken in 1st degree AV block, bradycardia <50 beats/minutes, hypotension <90 mm Hg systolic pressure, atrial fibrillation/flutter and simultaneous pre-excitation syndrome e.g. WPW syndrome, heart failure (previous compensation with cardiac glycosides/diuretics required). Verapamil may impair ability to drive or operate machinery, particularly in the initial stages of treatment and with concomitant consumption of alcohol. Verapamil markedly slows down the elimination of alcohol and prolongs the duration of the effects of alcohol.
",,"Treatment of overdose should be supportive. Beta-adrenergic stimulation or parenteral administration of calcium solution may increase calcium ion flux across the slow channel and have been used in the treatment of overdose with Verapamil. Verapamil cannot be removed by hemodialysis.
",,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",11
+1123,Venlafaxine Hydrochloride,venlafaxine-hydrochloride-1123,https://medex.com.bd/attachments/OesaraguaqEADFW1cEF0RNFLXrQspc/venlafaxine-hydrochloride-prescribing-information,Serotonin-norepinephrine reuptake inhibitor (SNRI),Social anxiety disorder,"Venlafaxine tablets is indicated for the treatment of major depressive disorder.
The efficacy of venlafaxine tablets, in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III ... Read more
Venlafaxine tablets is indicated for the treatment of major depressive disorder.
The efficacy of venlafaxine tablets, in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia
A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.
The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebocontrolled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use venlafaxine tablets / extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
","Serotonin-norepinephrine reuptake inhibitor (SNRI)
","The exact mechanism of action of venlafaxine is unknown, but appears to be associated with the its potentiation of neurotransmitter activity in the CNS. Venlafaxine and its active metabolite, O-desmethylvenlafaxine (ODV), inhibit the reuptake of both serotonin and norepinephrine with a potency greater for the 5-HT than for the NE reuptake process. Both venlafaxine and the ODV metabolite have weak inhibitory effects on the reuptake of dopamine but, unlike the tricyclics and similar to SSRIs, they are not active at histaminergic, muscarinic, or alpha(1)-adrenergic receptors.
","Initial Treatment: The recommended starting dose for venlafaxine tablets is 75 mg/day, administered in two or three divided doses, taken with food. Depending on tolerability and the need for further clinical effect, the dose may be increased to 150 mg/day. If needed, the dose should be further increased up to 225 mg/day. When increasing the dose, increments of up to 75 mg/day should be made at intervals of no less than 4 days. In outpatient settings there was no evidence of usefulness of doses greater than 225 mg/day for moderately depressed patients, but more severely depressed inpatients responded to a mean dose of 350 mg/day. Certain patients, including more severely depressed patients, may therefore respond more to higher doses, up to a maximum of 375 mg/day, generally in three divided doses
Dosage For Elderly Patients: No dose adjustment is recommended for elderly patients on the basis of age. As with any antidepressant, however, caution should be exercised in treating the elderly. When individualizing the dosage, extra care should be taken when increasing the dose.
Maintenance Treatment: It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacological therapy beyond response to the acute episode. In one study, in which patients responding during 8 weeks of acute treatment with venlafaxine hydrochloride extendedrelease capsules were assigned randomly to placebo or to the same dose of venlafaxine hydrochloride extended-release capsules (75, 150, or 225 mg/day, qAM) during 26 weeks of maintenance treatment as they had received during the acute stabilization phase, longer-term efficacy was demonstrated. A second longer-term study has demonstrated the efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then randomly assigned to placebo or venlafaxine tablets for periods of up to 52 weeks on the same dose (100 to 200 mg/day, on a b.i.d. schedule) (see Clinical Trials). Based on these limited data, it is not known whether or not the dose of venlafaxine tablets / extended-release capsules needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
Discontinuing Venlafaxine Tablet: Symptoms associated with discontinuation of venlafaxine tablets, other SNRIs, and SSRIs, have been reported. Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
",,"Increased risk of serotonin syndrome with TCA, SSRI, SNRI, lithium, sibutramine, tramadol. May increase serum levels with CYP3A4 inhibitors (e.g. ketoconazole, atazanavir, clarithromycin). May increase serum levels of haloperidol. May decrease serum levels of indinavir. May increase bleeding risk with aspirin, NSAIDs, warfarin and other anticoagulants.
","Concomitant use with MAOIs or within 14 days of discontinuing the MAOI. Use with linezolid or IV methylene blue.
","Changes in behaviour, suicidal ideation, agitation, tremor, nervousness, anxiety, insomnia, confusions, abnormal dreams, HTN, nausea, headache, asthenia, somnolence, dizziness, dry mouth, vomiting, constipation, diarrhoea, dyspepsia, abdominal pain, anorexia, sexual dysfunction, urinary frequency, visual disturbances, mydriasis, vasodilatation, paraesthesia, hypertonia, chills or fever, palpitations, wt gain or loss, arthralgia, myalgia, tinnitus, pruritus, dyspnoea, yawning, rashes, sweating, increased serum cholesterol, may impair platelet aggregation.
","Treatment Of Pregnant Women During The Third Trimester
Neonates exposed to venlafaxine tablets, USP, other SNRIs, or SSRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. When treating pregnant women with venlafaxine tablets during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.
","History of MI or unstable cardiac disease, seizure; hypomania or mania, increased intraocular pressure or at risk of acute narrow-angle galaucoma, at risk of bleeding. Renal and hepatic impairment. Gradual dose reduction is recommended rather than abrupt withdrawal. Pregnancy and lactation. Patient Counselling May impair ability to drive or operate machinery.
","Dosage For Patients With Hepatic Impairment: Given the decrease in clearance and increase in elimination half-life for both venlafaxine and ODV that is observed in patients with hepatic cirrhosis and mild and moderate hepatic impairment compared to normal subjects, it is recommended that the total daily dose be reduced by 50% in patients with mild to moderate hepatic impairment. Since there was much individual variability in clearance between subjects with cirrhosis, it may be necessary to reduce the dose even more than 50%, and individualization of dosing may be desirable in some patients.
Dosage For Patients With Renal Impairment: Given the decrease in clearance for venlafaxine and the increase in elimination half-life for both venlafaxine and ODV that is observed in patients with renal impairment (GFR = 10 to 70 mL/min) compared to normals, it is recommended that the total daily dose be reduced by 25% in patients with mild to moderate renal impairment. It is recommended that the total daily dose be reduced by 50% in patients undergoing hemodialysis. Since there was much individual variability in clearance between patients with renal impairment, individualization of dosing may be desirable in some patients.
","Symptoms: Sweating, dizziness, somnolence, mydriasis, convulsions, vomiting, ECG changes, cardiac arrhythmias and seizures.
Management: Symptomatic and supportive treatment. Ensure adequate airway, oxygenation and ventilation. Initiate gastric lavage immediately after ingestion. Admin activated charcoal to reduce absorption. Monitor cardiac rhythm and vital signs.
",,,"Store between 20-25° C.
",12
+2063,Venetoclax,venetoclax-2063,https://medex.com.bd/attachments/jQdJNVZKl8taomDZF2LsCACPDDJuHf/venetoclax-prescribing-information,Cytotoxic Chemotherapy,Chronic lymphocytic leukemia,"Venetoclax in combination with Rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.
Venetoclax monotherapy is indicated for the treatment of CLL:
+
+- In the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or
... Read more
Venetoclax in combination with Rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.
Venetoclax monotherapy is indicated for the treatment of CLL:
+
+- In the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or
+- In the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
+
","Cytotoxic Chemotherapy
","Venetoclax is a selective and orally bioavailable small-molecule inhibitor of BCL-2, an antiapoptotic protein. Overexpression of BCL-2 has been demonstrated in CLL cells where it mediates tumor cell survival and has been associated with resistance to chemotherapeutics. Venetoclax helps restore the process of apoptosis by binding directly to the BCL-2 protein, displacing pro-apoptotic proteins like BIM, triggering mitochondrial outer membrane permeabilization and the activation of caspases. In nonclinical studies, venetoclax has demonstrated cytotoxic activity in tumor cells that overexpress BCL-2.
","The starting dose is 20 mg of Venetoclax once daily for 7 days. The dose must be gradually increased over a period of 5 weeks up to the daily dose of 400 mg. The 5-week dose-titration schedule is designed to gradually reduce tumour burden (debulk) and decrease the risk of tumor lysis syndrome.
Post-titration dose for Venetoclax in combination with Rituximab: The recommended dose of Venetoclax in combination with Rituximab is 400 mg once daily. Rituximab should be administered after the patient has completed the dose-titration schedule and has received the recommended daily dose of 400 mg Venetoclax for 7 days. Venetoclax should be taken for 24 months from Cycle 1 Day 1 of Rituximab.
Post-titration dose for Venetoclax monotherapy: The recommended dose of Venetoclax is 400 mg once daily. Treatment should be continued until disease progression or no longer tolerated by the patient.
",,"CYP3A inhibitors: Co-administration of 400 mg once daily ketoconazole, a strong CYP3A, P-gp and BCRP inhibitor, for 7 days in 11 previously treated patients with NHL increased Venetoclax Cmax by 2.3-fold and AUC by 6.4-fold. Co-administration of 50 mg once daily ritonavir, a strong CYP3A and P-gp inhibitor, for 14 days in 6 healthy subjects increased Venetoclax Cmax by 2.4-fold and AUC by 7.9-fold. Co-administration of Venetoclax with other strong CYP3A4 inhibitors is predicted to increase Venetoclax AUC by on average 5.8- to 7.8-fold. Concomitant use of Venetoclax with strong CYP3A inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, ritonavir) at initiation and during the dose-titration phase is contraindicated due to increased risk for TLS.
At initiation and during the dose-titration phase, concomitant use of Venetoclax with moderate CYP3A inhibitors (e.g., ciprofloxacin, diltiazem, erythromycin, fluconazole, verapamil) should be avoided. Alternative treatments should be considered. If a moderate CYP3A inhibitor must be used, the initiation dose of Venetoclax and the doses for the titration phase should be reduced by at least 50%. Patients should be monitored more closely for signs and symptoms of TLS.
For patients who have completed the dose-titration phase and are on a steady daily dose of Venetoclax, the Venetoclax dose should be reduced by 50% when used concomitantly with moderate CYP3A inhibitors and by 75% when used concomitantly with strong CYP3A inhibitors. Patients should be monitored more closely for signs of toxicities and the dose may need to be further adjusted. The Venetoclax dose that was used prior to initiating the CYP3A inhibitor should be resumed 2 to 3 days after discontinuation of the inhibitor. Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with Venetoclax as they contain inhibitors of CYP3A.
P-gp and BCRP inhibitors: Venetoclax is a substrate for P-gp and BCRP , Co-administration of a 600 mg single dose of rifampin, a P-gp inhibitor, in 11 healthy subjects increased Venetoclax Cmax by 106% and AUC by 78%. Concomitant use of Venetoclax with P-gp and BCRP inhibitors at initiation and during the dose-titration phase should be avoided; if a P-gp and BCRP inhibitor must be used, patients should be monitored closely for signs of toxicities.
CYP3A inducers: Co-administration of 600 mg once daily rifampin, a strong CYP3A inducer, for 13 days in 10 healthy subjects decreased Venetoclax Cmax by 42% and AUC°° by 71%. Concomitant use of Venetoclax with strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin) or moderate CYP3A inducers (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin) should be avoided. Alternative treatments with less CYP3A induction should be considered. Preparations containing St. John's wort are contraindicated during treatment with Venetoclax, as efficacy may be reduced.
","Hypersensitivity to the active substance or to any of the excipients. Concomitant use of strong CYP3A inhibitors at initiation and during the dose-titration phase. Concomitant use of preparations containing St. John's wort
","The most commonly occurring side effects (>20%) of any grade in patients receiving Venetoclax in the combination study with Rituximab were neutropenia, diarrhoea, and upper respiratory tract infection. In the monotherapy studies, the most common side effects were neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract infection. The most frequently reported serious side effects (>2%) in patients receiving Venetoclax in combination with Rituximab were pneumonia, febrile neutropenia, and TLS. In the monotherapy studies, the most frequently reported serious side effects (>2%) were pneumonia and febrile neutropenia.
","Women of childbearing potential/Contraception in females: Women should avoid becoming pregnant while taking Venetoclax and for at least 30 days after ending treatment. Therefore, women of childbearing potential must use highly effective contraceptive measures while taking Venetoclax and for 30 days after stopping treatment. It is currently unknown whether Venetoclax may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method.
Pregnancy: Based on embryo-foetal toxicity studies in animals, Venetoclax may harm the fetus when administered to pregnant women. There is no adequate and well-controlled data from the use of Venetoclax in pregnant women. Studies in animals have shown reproductive toxicity. Venetoclax is not recommended during pregnancy and in women of childbearing potential not using highly effective contraception.
Breast-feeding: It is unknown whether Venetoclax or its metabolites are excreted in human milk. A risk to the breast-feeding child cannot be excluded. Breast-feeding should be discontinued during treatment with Venetoclax.
Fertility: No human data on the effect of Venetoclax on fertility are available. Based on testicular toxicity in dogs at clinically relevant exposures, male fertility may be compromised by treatment with Venetoclax. Before starting treatment, counselling on sperm storage may be considered in some male patients.
","Tumour lysis syndrome: Tumour lysis syndrome, including fatal events, has occurred in patients with previously treated CLL with high tumour burden when treated with Venetoclax. Venetoclax can cause rapid reduction in tumour, and thus poses a risk for TLS in the initial 5-weeks dose-titration phase. Changes in electrolytes consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of Venetoclax and at each dose increase. The risk of TLS is a continuum based on multiple factors, including comorbidities. Patients with high tumour burden (e.g., any lymph node with a diameter >5 cm or high ALC >25 x 109/1) are at greater risk of TLS when initiating enetoclax. Reduced renal function (CrCI <80 ml/min) further increases the risk. Patients should be assessed for risk and should receive appropriate prophylaxis for TLS, including hydration and anti-hyperuricaemics. Blood chemistries should be monitored and abnormalities managed promptly. Dosing should be interrupted if needed. More intensive measures (intravenous hydration, frequent monitoring, hospitalization) should be employed as overall risk increases. The instructions for ""Prevention of tumour lysis syndrome"" should be followed. Concomitant use of this medicinal product with strong or moderate CYP3A inhibitors increases Venetoclax exposure and may increase the risk for TLS at initiation and during the dose-titration phase. Also, inhibitors of P-gp or BCRP may increase Venetoclax exposure.
Neutropenia: Grade 3 or 4 neutropenia has been reported in patients treated with Venetoclax in the combination study with Rituximab (G028667/MURANO) and in the monotherapy studies. Complete blood counts should be monitored throughout the treatment period. Dose interruptions or reductions are recommended for patients with severe neutropenia. Serious infections including events of sepsis with fatal outcome have been reported. Supportive measures including antimicrobials for any signs of infection should be considered.
Immunization: The safety and efficacy of immunization with live attenuated vaccines during or following Venetoclax therapy have not been studied. Live vaccines should not be administered during treatment and thereafter until B-cell recovery.
CYP3A inducers: Co-administration of CYP3A4 inducers may lead to decreased Venetoclax exposure and consequently a risk for lack of efficacy. Concomitant use of Venetoclax with strong or moderate CYP3A4 inducers should be avoided.
Women of childbearing potential: Women of childbearing potential must use a highly effective method of contraception while taking Venetoclax.
","Elderly: No specific dose adjustment is required for elderly patients (aged >65 years).
Renal impairment: No dose adjustment is needed for patients with mild or moderate renal impairment (CrCI >30 ml/min and <90 mi/min). Patients with reduced renal function (CrCI <80 ml/min) may require more intensive prophylaxis and monitoring to reduce the risk of TLS at initiation and during the dose-titration phase. Safety in patients with severe renal impairment (CrCI <30 ml/min) or on dialysis has not been established, and a recommended dose for these patients has not been determined. Venetoclax should be administered to patients with severe renal impairment only if the benefit outweighs the risk and patients should be monitored closely for signs of toxicity due to increased risk of TLS.
Hepatic impairment: No dose adjustment is recommended in patients with mild or moderate hepatic impairment. Patients with moderate hepatic impairment should be monitored more closely for signs of toxicity at initiation and during the dose-titration phase. A dose reduction of at least 50% throughout treatment is recommended for patients with severe hepatic impairment. These patients should be monitored more closely for signs of toxicity.
Pediatric population: The safety and efficacy of Venetoclax in children aged less than 18 years have not been established. No data is available.
","There is no specific antidote for Venetoclax. Patients who experience overdose should be closely monitored and appropriate supportive treatment provided. During dose-titration phase, treatment should be interrupted and patients should be monitored carefully for signs and symptoms of TLS (fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, muscle or joint pain, abdominal pain and distension) along with other toxicities.
",,,"Store below 30°C. Keep Venetoclax out of the sight and reach of children. Protect from moisture and light.
",12
+1122,Vecuronium Bromide,vecuronium-bromide-1122,https://medex.com.bd/attachments/Hk3HtcHv7ivOlYBOEJ3aSdbh4rQUwa/vecuronium-bromide-prescribing-information,Non depolarizing muscle relaxants,Skeletal muscle relaxation,"Vecuronium Bromide is indicated as an adjunct to general anaesthesia to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery.
","Non depolarizing muscle relaxants
","Vecuronium bromide is a non-depolarising neuromuscular blocking agent. It blocks the transmission process between the motor nerve-ending and striated muscle by binding competitively with acetylcholine to the nicotinic receptors located in the motor end-plate region of striated muscle.
Unlike depolarising neuromuscular blocking agents, such as suxamethonium, Vecuronium bromide does not cause muscle fasciculations.
Within the clinical dosage range, Vecuronium bromide exerts neither vagolytic nor ganglion blocking activity.
","Like other neuromuscular blocking agents, Vecuronium should only be administered by, or under supervision of, experienced clinicians who are familiar with the action and use of these agents.
Like with other neuromuscular blocking agents, the dosage of Vecuronium should be individualised in each patient. The anaesthetic method used, the expected duration of surgery, the possible interaction with other medicines that are administered before or during anaesthesia and the condition of the patient should be taken into account when determining the dose. The use of an appropriate neuromuscular monitoring technique is recommended to monitor neuromuscular block and recovery.
Inhalational anaesthetics do potentiate the neuromuscular blocking effects of Vecuronium. This potentiation however, becomes clinically relevant in the course of anaesthesia, when the volatile agents have reached the tissue concentrations required for this interaction. Consequently, adjustments with Vecuronium should be made by administering smaller maintenance doses at less frequent intervals or by using lower infusion rates of Vecuronium during long lasting procedures (longer than 1 hour) under inhalational anaesthesia.
In adult patients the following dosage recommendations may serve as a general guideline for tracheal intubation and muscle relaxation for short to long lasting surgical procedures.
Tracheal intubation: The standard intubating dose during routine anaesthesia is 0.08 to 0.1 mg vecuronium bromide per kg body weight, after which adequate intubation conditions are established within 90 to 120 seconds in nearly all patients.
+
Dosages of Vecuronium for surgical procedures after intubation with suxamethonium:
+Recommended doses:
+
+- 0.03 to 0.05 mg vecuronium bromide per kg body weight.
+- If suxamethonium is used for intubation, the administration of Vecuronium should be delayed until the patient has clinically recovered from the neuromuscular block induced by suxamethonium.
+
+Maintenance dosing:
+
+- The recommended maintenance dose is 0.02 to 0.03 mg vecuronium bromide per kg body weight. These maintenance doses should best be given when twitch height has recovered to 25% of control twitch height.
+- Dose requirements for administration of Vecuronium by continuous infusion.
+- If Vecuronium is administered by continuous infusion, it is recommended to give a loading dose first (see 'Tracheal intubation') and, when neuromuscular block starts to recover, to start administration of Vecuronium by infusion. The infusion rate should be adjusted to maintain twitch response at 10% of control twitch height or to maintain 1 to 2 responses to train of four stimulation. In adults, the infusion rate required to maintain neuromuscular block at this level, ranges from 0.8 to 1.4 µg vecuronium bromide/kg/min. For neonates and infants, see below. Repeat monitoring of neuromuscular block is recommended since infusion rate requirements vary from patient to patient and with the anaesthetic method used.
+
+
+
Dosing in elderly patients:
+
+- The same intubation and maintenance doses as for younger adults (0.08-0.1 mg/kg and 0.02-0.03 mg/kg, respectively) can be used. However, the duration of action is prolonged in elderly compared to younger subjects due to changes in pharmacokinetic mechanisms. The onset time in elderly is similar to younger adults.
+- In caesarean section and neonatal surgery the dose should not exceed 0.1 mg/kg.
+
+
+
Dosing in paediatric patients:
+Because of the possible variation of the sensitivity of the neuromuscular junction, especially in neonates (up to 4 weeks) and probably in infants up to 4 months of age, an initial test dose of 0.01 to 0.02 mg vecuronium bromide per kg body weight followed by incremental doses until 90 to 95% depression of twitch response is achieved is recommended. In neonatal surgery the dose should not exceed 0.1 mg/kg. Dose requirements in neonates and infants (1-12 months) are the same as in adults. However, since the onset time of Vecuronium in these patients is considerably shorter than in adults and children, the use of high intubating doses in general is not required for early development of good intubating conditions.
Since the duration of action and recovery time with Vecuronium is longer in neonates and infants than in children and adults, maintenance doses are required less frequently.
Dose requirements in children (2-10 years) are higher. However, the same intubation and maintenance doses as for adults (0.08-0.1 mg/kg and 0.02-0.03 mg/kg, respectively) are usually sufficient. Since the duration of action is shorter in children, maintenance doses are required more frequently.
Although there is very little information on dosage in adolescents, it is advised to use the same dose as in adults, based on the physiological development at this age.
Dosing in overweight and obese patients
When used in overweight or obese patients (defined as patients with a body weight of 30% or more above ideal body weight) doses should be reduced taking into account an ideal body weight.
Higher doses: Should there be reason for selection of larger doses in individual patients; initial doses ranging from 0.15 mg up to 0.30 mg vecuronium bromide per kg body weight have been administered during surgery both under halothane and neurolept anaesthesia without adverse cardiovascular effects being noted as long as ventilation is properly maintained. The use of these high dosages of Vecuronium pharmacodynamically decreases the onset time and increases the duration of action.
","Vecuronium should be administered following reconstitution. Vecuronium is administered intravenously either as a bolus injection or as a continuous infusion
","The following agents have been shown to influence the magnitude and/or duration of action of non-depolarizing neuromuscular blocking agents:
+
Effect of Other Agents on Vecuronium:
+
Increased Effect:
+
+- Halogenated volatile anaesthetics potentiate the neuromuscular block of Vecuronium. The effect only becomes apparent with maintenance dosing (see also Dosage and Administration). Reversal of the block with anticholinesterase inhibitors could also be inhibited.
+- After intubation with suxamethonium
+- Long-term concomitant use of corticosteroids and Vecuronium in the ICU may result in prolonged duration of neuromuscular block or myopathy.
+
+Other medicines:
+
+- antibiotics: aminoglycoside, lincosamide and polypeptide antibiotics, acylaminopenicillin antibiotics,
+- diuretics, quinidine, magnesium salts, calcium channel blocking agents, lithium salts, cimetidine, lidocaine and acute administration of phenytoin or β-blocking agents
+- Recurarization has been reported after post-operative administration of: aminoglycoside, lincosamide, polypeptide and acylamino-penicillin antibiotics, quinidine and magnesium salts
+
+
Decreased Effect (possible higher dose requirements):
+
+- prior chronic administration of phenytoin or carbamazepine
+- Variable Effect
+- Administration of other non-depolarizing neuromuscular blocking agents in combination with Vecuronium may produce attenuation or potentiation of the neuromuscular block, depending on the order of administration and the neuromuscular blocking agent used.
+- Suxamethonium given after the administration of Vecuronium may produce potentiation or attenuation of the neuromuscular blocking effect of Vecuronium.
+
+
+
Effect of Vecuronium on other agents:
+Effect of Vecuronium on lidocaine: Vecuronium combined with lidocaine may result in a quicker onset of action of lidocaine.
",,"Side effects are rare (<1/1000). The most commonly occurring side effects include changes in vital signs and prolonged neuromuscular block. The most frequently reported side effects during post-marketing surveillance is 'anaphylactic and anaphylactoid reactions' and associated symptoms (reporting frequency <1/100,000).
","There are insufficient data on the use of Vecuronium during animal or human pregnancy to assess potential harm to the foetus. Vecuronium should be given to a pregnant woman only when the attending physician decides that the benefits outweigh the risks.
Caesarean section: Studies with Vecuronium, administered in doses up to 0.1mg/kg, have shown its safety for use in caesarean section. In caesarean section the dose should not exceed 0.1mg/kg. In several clinical studies Vecuronium did not affect Apgar score, foetal muscle tonus or cardiorespiratory adaptation. From umbilical cord blood sampling it is apparent that only very little placental transfer of Vecuronium occurs which did not lead to the observation of any clinical adverse effect in the newborn.
Reversal of a Vecuronium induced neuromuscular block may be inhibited or unsatisfactory in patients receiving magnesium sulphate for toxaemia of pregnancy because magnesium salts enhance neuromuscular block.Therefore, in patients receiving magnesium sulphate, the dosage of Vecuronium should be reduced and be carefully titrated to twitch response.
Lactation: There are no human data on the use of Vecuronium during lactation. Vecuronium should be given to lactating women only when the attending physician decides that the benefits outweigh the risks.
","Since Vecuronium causes paralysis of the respiratory muscles, ventilatory support is mandatory for patients treated with this medicine until adequate spontaneous respiration is restored.
As with other neuromuscular blocking agents, residual curarization has been reported for Vecuronium. In order to prevent complications resulting from residual curarization, it is recommended to extubate only after the patient has recovered sufficiently from neuromuscular block. Other factors which could cause residual curarization after extubation in the post-operative phase (such as medicine interactions or patient condition) should also be considered. If not used as part of standard clinical practice, the use of a reversal agent should be considered, especially in those cases where residual curarization is more likely to occur.
Anaphylactic reactions can occur following the administration of neuromuscular blocking agents. Precautions for treating such reactions should always be taken. Particularly in the case of previous anaphylactic reactions to muscle relaxants, special precautions should be taken since allergic cross-reactivity to muscle relaxants has been reported.
Since Vecuronium has no cardiovascular effects within the clinical dosage range, it does not attenuate bradycardia that may occur due to the use of some types of anaesthetics and opiates or due to vagal reflexes during surgery. Therefore, reassessment of the use and/or dosage of vagolytic medicines such as atropine for premedication or at induction of anaesthesia, may be of value for surgical procedures during which vagal reactions are more likely to occur (e.g. surgical procedures where anaesthetic medicines with known vagal stimulatory effects are used, ophthalmic, abdominal or anorectal surgery, etc).
In general, following long term use of neuromuscular blocking agents in the ICU, prolonged paralysis and/or skeletal muscle weakness has been noted. In order to help preclude possible prolongation of neuromuscular block and/or overdosage it is strongly recommended that neuromuscular transmission is monitored throughout the use of muscle relaxants. In addition, patients should receive adequate analgesia and sedation. Furthermore, muscle relaxants should be titrated to effect in the individual patients by or under supervision of experienced clinicians who are familiar with their actions and with appropriate neuromuscular monitoring techniques. Myopathy after long term administration of non-depolarizing neuromuscular blocking agents in the ICU in combination with corticosteroid therapy has been reported frequently. Therefore, for patients receiving both neuromuscular blocking agents and corticosteroids, the period of use of the neuromuscular blocking agent should be limited as much as possible.
",,"In the event of overdosage and prolonged neuromuscular block, the patient should continue to receive ventilatory support and sedation. Upon start of spontaneous recovery an acetylcholinesterase inhibitor (e.g. neostigmine, edrophonium, pyridostigmine) should be administered in adequate doses.
When administration of an acetylcholinesterase-inhibiting agent fails to reverse the neuromuscular effects of Vecuronium, ventilation must be continued until spontaneous breathing is restored. Repeated dosage of an acetylcholinesterase inhibitor can be dangerous.
",,"Addition of 5 mL water for injections results in an isotonic solution of pH 4 containing 2 mg vecuronium bromide per ml. (2 mg/ml)
Alternatively, in order to obtain a solution with a lower concentration, Vecuronium 10 mg may be reconstituted with a volume up to 10 ml respectively of the following infusion fluids:
+
+- 5% glucose injection fluid
+- 0.9% sodium chloride injection fluid
+- Lactated Ringer's solution
+- Lactated Ringer's injection and 5% glucose
+- Glucose 5% and 0.9% sodium chloride injection
+
","Store between 20-25° C. Protect from light.
",12
+1121,Varicella Virus Vaccine,varicella-virus-vaccine-1121,https://medex.com.bd/attachments/Fh8at2UDDZwwIpGipVxqftmjX2PwLj/varicella-virus-vaccine-prescribing-information,"Vaccines, Anti-sera & Immunoglobulin",Varicella infection,"This is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age and older.
","Vaccines, Anti-sera & Immunoglobulin
","Varicella Virus Vaccine induces both cell-mediated and humoral immune responses to varicella-zoster virus. The relative contributions of humoral immunity and cell-mediated immunity to protection from varicella are unknown.
","Each 0.5 mL dose of Varicella Virus Vaccine is administered subcutaneously. Inject the vaccine subcutaneously into the outer aspect of the deltoid region of the upper arm or into the higher anterolateral area of the thigh.
Children (12 months to 12 years of age): The first dose is administered at 12 to 15 months of age but may be given anytime through 12 years of age. The second dose is administered at 4 to 6 years of age. At least 3 months should elapse between a dose of varicella-containing vaccine. At least 1 month should elapse between a dose of measles-containing vaccine and a dose of Varicella Virus Vaccine if the vaccines are not given concurrently.
Adolescents (≥13 years of age) and Adults: Two doses of Varicella Virus Vaccine are administered at a minimum interval of 4 weeks.
",,"Reye syndrome has been reported in children and adolescents following the use of salicylates during wild-type varicella infection. Administration of immune globulins and other blood products concurrently with Varicella Virus Vaccine vaccine may interfere with the expected immune response. Varicella Virus Vaccine vaccination may result in a temporary depression of purified protein derivative (PPD) tuberculin skin sensitivity.
","Severe Allergic Reaction: Do not administer Varicella Virus Vaccine to individuals with a history of anaphylactic or severe allergic reaction to any component of the vaccine (including neomycin and gelatin) or to a previous dose of a varicella-containing vaccine.
Immunosuppression: Do not administer Varicella Virus Vaccine to individuals who are immunodeficient or immunosuppressed due to disease or medical therapy. Disseminated varicella disease and extensive vaccine associated rash have been reported in individuals who are immunosuppressed or immunodeficient who were inadvertently vaccinated with a varicella-containing vaccine.
Moderate or Severe Febrile Illness: Do not administer Varicella Virus Vaccine to individuals with an active febrile illness with fever >38.5°C.
Active Untreated Tuberculosis: Do not administer Varicella Virus Vaccine to individuals with active, untreated tuberculosis (TB).
Pregnancy: Do not administer Varicella Virus Vaccine to individuals who are pregnant or planning on becoming pregnant in the next 3 months. Wild-type varicella is known to cause fetal harm.
","Frequently reported (≥10%) adverse reactions in children ages 1 to 12 years include:
+
+- fever ≥102.0°F (38.9°C) oral: 14.7%
+- injection-site complaints: 19.3%
+
+Frequently reported (≥10%) adverse reactions in adolescents and adults ages 13 years and older include:
+
+- fever ≥100.0°F (37.8°C) oral: 10.2%
+- injection-site complaints: 24.4%
+
+Other reported adverse reactions in all age groups include:
+
+- varicella-like rash (injection site)
+- varicella-like rash (generalized)
+
","Varicella Virus Vaccine is contraindicated for use in pregnant women because the vaccine contains live, attenuated varicella virus, and it is known that wild-type varicella virus, if acquired during pregnancy, can cause congenital varicella syndrome. No increased risk for miscarriage, major birth defect or congenital varicella syndrome was observed in a pregnancy exposure registry that monitored outcomes after inadvertent use. There are no relevant animal data.
It is not known whether varicella vaccine virus is excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Varicella Virus Vaccine, and any potential adverse effects on the breastfed child from Varicella Virus Vaccine or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.
","Evaluate individuals for immune competence prior to administration of Varicella Virus Vaccine if there is a family history of congenital or hereditary immunodeficiency. Avoid close contact with high-risk individuals susceptible to varicella because of possible transmission of varicella vaccine virus. Immune Globulins (IG) and other blood products should not be given concomitantly with Varicella Virus Vaccine. Avoid use of salicylates for 6 weeks following administration of Varicella Virus Vaccine to children and adolescents.
","Pediatric Use: No clinical data are available on safety or efficacy of varicella virus vaccine in children less than 12 months of age.
Geriatric Use: Clinical studies of varicella virus vaccine did not include sufficient numbers of seronegative subjects aged 65 and over to determine whether they respond differently from younger subjects.
",,,"Use a sterile syringe free of preservatives, antiseptics, and detergents for each reconstitution and injection of Varicella Virus Vaccine because these substances may inactivate the vaccine virus. When reconstituting the vaccine, use only the sterile diluent supplied with Varicella Virus Vaccine. The sterile diluent does not contain preservatives or other anti-viral substances which might inactivate the vaccine virus. To reconstitute the vaccine, withdraw the total volume of supplied sterile diluent and inject into the lyophilized vaccine vial. Agitate to dissolve completely. Discard if the lyophilized vaccine cannot be dissolved. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the product if particulates are present or if it appears discolored. Visually inspect the vaccine before and after reconstitution prior to administration. Before reconstitution, the lyophilized vaccine is a white compact crystalline plug. Varicella Virus Vaccine, when reconstituted, is a clear, colorless to pale yellow liquid. Withdraw the entire amount of reconstituted vaccine, inject the total volume and discard vial. To minimize loss of potency, administer Varicella Virus Vaccine immediately after reconstitution. Discard if reconstituted vaccine is not used within 30 minutes. Do not freeze reconstituted vaccine. Do not combine Varicella Virus Vaccine with any other vaccine through reconstitution or mixing.
","Store between 2-8° C. Do not freeze. Protect from light. Keep out of the reach of children.
",12
+1120,Varenicline Tartrate,varenicline-tartrate-1120,https://medex.com.bd/attachments/NM2fWvt10MElH0DrNJgUq0NyzGesAO/varenicline-tartrate-prescribing-information,Drugs used in substance dependence,Smoking cessation aid,"Varenicline is indicated for use as an aid to smoking cessation treatment.
","Drugs used in substance dependence
","Varenicline binds with high affinity and selectivity at α4β2 neuronal nicotinic acetylcholinereceptors. The efficacy of Varenicline in smoking cessation is believed to be the result of varenicline's activity at α4β2 sub-type of the nicotinic receptor where its binding produces agonist activity, while simultaneously preventing nicotine binding to these receptors.
Electrophysiology studies in vitro and neurochemical studies in vivo have shown that varenicline binds to α4β2 neuronal nicotinic acetylcholine receptors and stimulates receptor-mediated activity, but at a significantly lower level than nicotine. Varenicline blocks the ability of nicotine to activate α4β2 receptors and thus to stimulate the central nervous mesolimbic dopamine system, believed to be the neuronal mechanism underlying reinforcement and reward experienced upon smoking. Varenicline is highly selective and binds more potently to α4β2 receptors than to other common nicotinic receptors ( >500-fold α3β4, >3,500fold α7, >20,000-fold α1βγδ), or to non-nicotinic receptors and transporters (> 2,000-fold). Varenicline also binds with moderate affinity (Ki = 350 nM) to the 5-HT3 receptor.
","Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided additional advice and support. Provide patients with appropriate educational materials and counseling to support the quit attempt.
The patient should set a date to stop smoking. Begin Varenicline dosing one week before this date. Alternatively, the patient can begin Varenicline dosing and then quit smoking between days 8 and 35 of treatment.
The recommended dose of Varenicline is 1 mg twice daily following a 1-week titration as follows:
+
+- Days 1-3: 0.5 mg once daily
+- Days 4-7: 0.5 mg twice daily
+- Day 8-end of treatment: 1 mg twice daily
+
+Patients should be treated with Varenicline for 12 weeks. For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with Varenicline is recommended to further increase the likelihood of long-term abstinence.
For patients who are sure that they are not able or willing to quit abruptly, consider a gradual approach to quitting smoking with Varenicline. Patients should begin Varenicline dosing and reduce smoking by 50% from baseline within the first four weeks, by an additional 50% in the next four weeks, and continue reducing with the goal of reaching complete abstinence by 12 weeks. Continue Varenicline treatment for an additional 12 weeks, for a total of 24 weeks of treatment. Encourage patients to attempt quitting sooner if they feel ready
Patients who are motivated to quit, and who did not succeed in stopping smoking during prior Varenicline therapy for reasons other than intolerability due to adverse events or who relapsed after treatment, should be encouraged to make another attempt with Varenicline once factors contributing to the failed attempt have been identified and addressed.
Consider a temporary or permanent dose reduction in patients who cannot tolerate the adverse effects of Varenicline.
","Varenicline should be taken orally after eating and with a full glass of water.
","May increase intoxicating effects of alcohol.
","Known hypersensitivity to varenicline or to any of the excipients in the product (microcrystalline cellulose, dibasic calcium phosphate, anhydrous, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Opadry Blue/White and Opadry Clear).
","Nasopharyngitis, bronchitis, sinusitis, increased wt, decreased &/or increased appetite, abnormal dreams, insomnia, headache, somnolence, dizziness, dysgeusia, dyspnea, cough, nausea, GERD, vomiting, constipation, diarrhea, abdominal distension & pain, toothache, dyspepsia, flatulence, dry mouth, rash, pruritus, arthralgia, myalgia, back pain, chest pain, fatigue, abnormal liver function test.
","Use in Pregnancy: Category C. There are no adequate and well-controlled studies in pregnant women. Varenicline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
Use in Lactation: It is unknown whether varenicline is excreted in human breast milk. Animal studies suggest that varenicline is excreted in breast milk. A decision on whether to discontinue breast-feeding or to discontinue therapy with varenicline should be made taking into account the benefit of breast-feeding to the child and the benefit of varenicline therapy to the woman
","Discontinue use if changes in behavior or thinking, agitation or depressed mood, anxiety, psychosis, mood swings, aggressive behavior, agitation, depressed mood, suicidal ideation & behavior. Concomitant use in patients attempting to quit smoking. Patients with history of seizures or other conditions that potentially lower seizure threshold. Report if patients had history of psychiatric illness prior to initiation. Hypersensitivity reactions including angioedema, swelling of the face, mouth (tongue, lips, gums), neck (throat & larynx) & extremities. Severe cutaneous reactions including Stevens-Johnson syndrome & erythema multiforme (rare).
Special Precautions for Disposal and Other Handling: No special requirements for disposal.
",,,,,,10
+1119,Vardenafil,vardenafil-1119,https://medex.com.bd/attachments/V2CVeODT1POPKpqJzz0UEWdxO4evtu/vardenafil-prescribing-information,Drugs for Erectile Dysfunction,Erectile dysfunction,"Vardenafil is used to treat erectile dysfunction (ED).
","Drugs for Erectile Dysfunction
","Vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5). Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released in the corpus cavernosum & activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in an erection. Inhibition of PDE5 enhances erectile function by increasing the amount of cGMP. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation.
","The recommended starting dose: 10 mg once daily, taken orally approximately 60 minutes before sexual activity. The dose may be increased to a maximum dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. Vardenafil can be taken with or without food.
Geriatrics: A starting dose of 5 mg should be considered in patients >65 years of age.
Renal impaired patients: In patients with renal impairment, no dose adjustment is required.
Hepatic impaired patients: In patients with moderate hepatic impairment, a starting dose of 5 mg is recommended and the maximum dose should not exceed 10 mg. Do not use in patients with severe hepatic impairment.
",,"Vardenafil can potentiate the blood pressure lowering effect of antihypertensive agents. In clinical studies, single doses of Vardenafil 20 mg caused a mean decrease in blood pressure of 7 mmHg systolic and 8 mmHg diastolic. Caution should be taken when co-administered with other vasodilators including alpha blockers. Vardenafil does not potentiate the hypotensive effect of alcohol. CYP3A4 inhibitors (ketoconazole, indinavir, ritonavir and erythromycin) may reduce Vardenafil excretion from body
","Administration of Vardenafil with nitrates (either regularly or intermittently) and nitric oxide donors is contraindicated because Vardenafil may potentiate hypotensive effect of nitrates. It is also contraindicated for patients who have shown hypersensitivity to Vardenafil or any of the ingredients of this product.
","The most common side effects with Vardenafil are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness or back pain.
","Vardenafil is not indicated for women.
","Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. In men for whom sexual activity is not recommended because of their underlying cardiovascular status, Vardenafil generally should not be used.
",,"The maximum dose of Vardenafil for which human data are available is a single 120 mg. Where the majority of these subjects experienced blurred vision and back pain. Single doses up to 80 mg and multiple doses up to 40 mg administered once daily over 4 weeks did not show serious adverse effects. In cases of overdose, contact with the doctor immediately.
",,,"Store at room temperature and protect from light and moisture. Keep out of the reach of children.
",11
+1140,Yellow Fever Vaccine,yellow-fever-vaccine-1140,https://medex.com.bd/attachments/xgd9qVPSrvkfxrGVZpk68gRvSnwN9S/yellow-fever-vaccine-prescribing-information,,,"Yellow Fever Vaccine provides protection against a serious infectious disease called yellow fever. Yellow fever occurs in certain areas of the world and is spread to man through the bites of infected mosquitoes.
Yellow Fever Vaccine is given to people who:
+
+- are travelling to, passing through or living in an area where yellow fever occurs,
... Read more
Yellow Fever Vaccine provides protection against a serious infectious disease called yellow fever. Yellow fever occurs in certain areas of the world and is spread to man through the bites of infected mosquitoes.
Yellow Fever Vaccine is given to people who:
+
+- are travelling to, passing through or living in an area where yellow fever occurs,
+- are travelling to any country that requires an International Certificate of Vaccination for entry (this may depend on the countries previously visited during the same trip),
+- may handle infectious materials such as laboratory workers.
+
+To obtain a valid vaccination certificate against yellow fever, it is necessary to be vaccinated in an approved vaccination centre by a qualified and trained healthcare professional so that an International Certificate of Vaccination can be issued. This certificate is valid from 10 days after the first dose of vaccine. In some circumstances, when a booster is needed, the certificate (see Section 3) is valid immediately after the injection
",,"Live, attenuated virus stimulates active immunity to Yellow fever; conveys active immunity via stimulation of production of endogenously produced antibodies. Yellow fever vaccine is used for active immunisation against yellow fever. Each dose (usually 0.5 ml) contains at least 1000 mouse LD50 units.
","Yellow Fever Vaccine is given as a single, 0.5 millilitre dose to adults and children from 6 months of age. The first dose should be given at least 10 days before protection from yellow fever is needed. This is because it takes 10 days for the first dose of vaccine to work and provide good protection against the yellow fever virus. The protection provided by this dose is expected to last at least 10 years and maybe life-long. In some circumstances, a booster with one dose (0.5 millilitre) may be needed:
+
+- if you or your child had an insufficient response to the first dose and you or your child continue to be at risk for yellow fever virus infection.
+- or depending on official recommendations.
+
+Yellow Fever Vaccine is given as an injection by a qualified and trained healthcare professional. It is usually injected just underneath the skin but it can be given into a muscle. It must not be injected into a blood vessel.
",,"Tell your healthcare professional if you are taking, have recently taken or might take any other medicines. If you have recently had any treatment or medicine which may have weakened your immune system, the vaccination must be delayed until your laboratory results show that your immune system has recovered. Your doctor will advise you when it is safe for you to be vaccinated. Yellow Fever Vaccine can be given at the same time as measles vaccine or vaccines against typhoid fever (those containing the Vi capsular polysaccharide) and/or hepatitis A. Vaccination with Yellow Fever Vaccine may lead to false positive results of blood tests for dengue or Japanese encephalitis. If you or your child have in the future such tests prescribed, please inform your doctor about this vaccination.
","Do not use Yellow Fever Vaccine if you or your child are allergic to:
+
+- the active substance, or
+- any of the other ingredients of this vaccine (listed in Section 6), or
+- eggs or chicken proteins.
+- have experienced a severe allergic reaction after a previous dose of any yellow fever vaccine,
+- is less than 6 months old,
+- have a poor or weakened immune system for any reason, such as illness or medical treatments (for example high-dose steroids, or any other medicines that affect the immune system, or chemotherapy). If you are unsure whether the medication may affect your or your child’s immune system, discuss with your healthcare professional before the vaccine is administered.
+- have a weakened immune system due to HIV infection. Your healthcare professional will advise you if you or your child can still receive Yellow Fever Vaccine based on the results of your blood tests,
+- are infected with HIV and have active symptoms due to the infection,
+- have a history of problems with your or your child’s thymus gland or have had the thymus gland removed for any reason,
+- have an illness with a high or moderate fever or an acute illness. The vaccination will be postponed until you or your child have recovered.
+
","The following serious side effects have sometimes been reported: Allergic reactions:
+
+- Rash, itching or hives on the skin
+- Swelling of the face, lips, tongue or other parts of the body
+- Difficulty swallowing or breathing
+- Loss of consciousness
+
","If you are pregnant, or breastfeeding, think you may be pregnant or are planning to have a baby, ask your healthcare professional for advice before being vaccinated. You should not receive Yellow Fever Vaccine during pregnancy or breastfeeding unless this cannot be avoided. Also, it is recommended that you do not become pregnant within one month after receiving Yellow Fever Vaccine. Your healthcare professional can advise you on whether it is essential that you are vaccinated. In case vaccination is needed, it is recommended to interrupt breastfeeding for at least 2 weeks after you receive Yellow Fever Vaccine. In case you receive the vaccine while pregnant or breastfeeding, consult your healthcare professional.
","It is important to tell your healthcare professional if any of the points below apply to you or your child. If there is anything you do not understand, ask your healthcare professional to explain.
Before using Yellow Fever Vaccine, it is important that you complete a risk assessment with a trained healthcare professional, to determine whether you should receive the vaccine.
+
+- If you are over 60 years old or if your child is less than 9 months as you have an increased risk of certain types of severe but rare reactions to the vaccine (including serious reactions that affect the brain and nerves, and vital organs). You will only be given the vaccine if the risk of infection with the virus is well established in countries where you are going to stay.
+- If your child is aged 6 to 9 months. Yellow Fever Vaccine may be given to children aged between 6 and 9 months only in special situations and on the basis of current official advice.
+- If you or your child are infected by the HIV virus but do not have active symptoms due to the infection. Your healthcare professional will advise if Yellow Fever Vaccine can be given based on the results of laboratory tests and specialist advice.
+- If you or your child have any bleeding disorder (such as haemophilia or low level of platelets) or are taking any medicines that stop the blood clotting normally. You can still be given Yellow Fever Vaccine provided that it is injected under the skin and not into muscle.
+- If you had any allergic reaction to latex. The tip cap of the pre-filled syringe contains a natural rubber latex derivative which may cause an allergic reaction.
+
",,,,,"Keep out of the sight and reach of children. Do not use this vaccine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2°C-8°C). Do not freeze.
",9
+1139,Xylometazoline Hydrochloride,xylometazoline-hydrochloride-1139,https://medex.com.bd/attachments/eQf9Tg4X88I01Szmhvvt7sjeYd1r0W/xylometazoline-hydrochloride-prescribing-information,Nasal Anti-histamine preparations,Sinusitis,"Xylometazoline is indicated in-
+
+- Nasal congestion in colds, rhinitis, sinusitis, headache.
+- Tubal block and serous otitis media associated with nasal congestion.
+
","Nasal Anti-histamine preparations
","Nasal congestion is caused by various etiologies, such as rhinosinusitis and allergic or non-allergic rhinitis, leading to congestion of the venous sinusoids lining the nasal mucosa. Activation of α-adrenergic receptors leads to vasoconstriction of the blood vessels of the nasal mucosa and resumption of nasal airflow. As the most abundantly expressed in the human nasal mucosa, α1A- and α2B-adrenoceptors may play the most important role in vasoconstriction of the human nasal mucosa. Xylometazoline is a more selective agonist at α2B-adrenoceptors, with affinity at α1A-, α2A-, α2C-, α1B-, and α1D-adrenoceptors. Xylometazoline decreases nasal resistance during inspiration and expiration and increases the volume of nasal airflow. Compared to oxymetazoline, another imidazoline nasal decongestant, xylometazoline had a slightly faster onset of action although they had a similar duration of action. In one study, subjects with nasal congestion reported relief of earache and sore throat in addition to nasal decongestion: it is speculated that oxymetazoline mediates this effect by causing vasoconstriction of the nasal mucosa that contains the venous sinuses and nasal decongestion allows breathing through the nose, providing relief from sore throat caused by mouth breathing that dries and irritates the throat.
","Adults: Xylometazoline 0.1%: 2 or 3 drops in each nostril two to three times daily. Xylometazoline 0.1% should not be used for children under the age of 12 years.
Children 6 to 12 years of age: Xylometazoline 0.05%: 2 or 3 drops in each nostril two or three times daily.
Children less than 6 years of age: Xylometazoline 0.05%: 1 drop in each nostril two or three times daily.
Infants less than 3 months: Not to be used in infants less than 3 months.
",,"No drug interactions have been reported.
","Xylometazoline nasal drops is contraindicated in patients with transsphenoidal hypophysectomy or surgery exposing the dura mater. It is also contraindicated in patients who are hypersensitive to Xylometazoline. Each Xylometazoline nasal drop should be used by one person only to prevent any cross-infection. Patients are advised not to take decongestants for more than seven consecutive days.
","The following side-effects have occasionally been encountered:
+
+- A burning sensation in the nose and throat
+- Local irritation
+- Nausea and dryness of the nasal mucosa.
+
","Pregnancy category C. Xylometazoline should not be used during pregnancy. The use of Otrivin while breastfeeding should only take place on the instructions of a doctor.
","Xylometazoline Hydrochloride nasal drops for adults (0.1%) should not be used for children below 12 years. Drops should not be used for long time in cases with chronic rhinitis. Prolonged use of the drops may cause rebound congestion and drug induced rhinitis.
",,,,,"Protect from light. For reasons of hygiene, do not use the bottle more than 28 days after opening it.
",10
+1461,White soft paraffin + Liquid paraffin + Wool alcohol,white-soft-paraffin-liquid-paraffin-wool-alcohol-1461,,Emollients & combined preparations,Ophthalmic surgery,"White soft paraffin, Liquid paraffin & Wool alcohol combination eye ointment is indicated in dry eye condition particularly useful at night as it remains in the eye longer than drops. It is used as adjunctive therapy to lubricate and protect the eye in conditions such as exposure keratitis, decreased corneal sensitivity, recurrent corneal erosions, keratitis sicca, and ophthalmic surgery.
","Emollients & combined preparations
","White soft paraffin, Liquid paraffin & Wool alcohol combination eye ointment produce a transparent, lubricating and moistening film on the surface of the eyeball. White soft paraffin, Liquid paraffin & Wool alcohol eye ointment provides soothing relief from the symptoms of dry eyes such as soreness, irritation or a gritty sensation. These may be caused by inadequate production of tears to keep the eye moist or by things such as certain medical conditions or treatment. The ointment also helps to protect the eyeball and can thus be useful for people who suffer from recurrent corneal epithelial erosion.
","Apply a ribbon of ointment (1-1.5 cm) into the affected eye(s) prior to going to sleep or as directed by doctor.
",,,"Hypersensivity to any components of the medication
","Stinging/redness in the eye, widened pupils or blurred vision may occur.
","Pregnancy: There is no data from the use of White paraffin, Liquid paraffin & Wool alcohol combination eye ointment in pregnant women. However, all three components are pharmacologically inert, non-irritating and nontoxic.
Lactation: It is unknown that White paraffin, Liquid paraffin & Wool alcohol eye ointment are excreted in human milk.
","Ophthalmic use only. If patients experience headache, eye pain, vision changes, irritation of the eyes, persistent redness or if the condition worsens or persists for more than 72 hours discontinue use and consult with doctor.
",,,,,"Store in a cool and dry place, away from light. Keep out of reach of children. Do not touch the tip to surfaces since this may contaminate the product. Do not use the medicine after one month of first opening.
",9
+1439,White Soft Paraffin + Liquid Paraffin,white-soft-paraffin-liquid-paraffin-1439,https://medex.com.bd/attachments/jeQU8O3wwmnFicqx2LTGiDNOeHuFno/white-soft-paraffin-liquid-paraffin-prescribing-information,Emollients & combined preparations,Dry skin,"For general use as an emollient in the symptomatic relief of dry skin conditions.
","Emollients & combined preparations
","White Soft Paraffin and Liquid Paraffin are emollients with occlusive properties for topical application. There is no significant systemic absorption of the active ingredients but has substantial penetration into the stratum corneum.
","Apply a thin film of the ointment to the affected area of the skin, in the direction of hair growth, as required. Repeat as necessary. Ideally the product should be applied three or four times a day or at least twice a day. In adults, where a large area of the body is affected, up to 500 g a week may be used. For topical administration only.
",,,,"Prolong use may cause folliculitis, should this occur, use of the product should be discontinued.
","The safety of White Soft Paraffin and Liquid Paraffin during pregnancy and lactation has not been established, but use during this periods is not considered to constitute a hazard.
","This topical agent should be applied in the direction of hair growth to reduce the incidence of folliculitis.
",,"This topical agent has low toxicity and if ingested treatment should be supportive and symptomatic. Gastric lavage should not be attempted following ingestion of paraffin-based products, due to the risk of inhalation or aspiration into the lungs.
",,,"Do not store above 30° C. Keep away from light and out of the reach of children.
",9
+1489,Water for injection,water-for-injection-1489,,Other preparations,Irrigation solution,"Water for injection is water of extra high quality without significant contamination. A sterile version is used for making solutions that will be given by injection. Before such use other substances generally must be added to make the solution more or less isotonic. It can be given by injection into ... Read more
Water for injection is water of extra high quality without significant contamination. A sterile version is used for making solutions that will be given by injection. Before such use other substances generally must be added to make the solution more or less isotonic. It can be given by injection into a vein, muscle, or under the skin. A non-sterile version may be used in manufacturing with sterilization occurring later in the production process.
","Other preparations
","If it is given by injection into a vein without making it more or less isotonic, breakdown of red blood cells may occur. This can then result in kidney problems. Excessive amount may also result in fluid overload. Water for injection is generally made by distillation or reverse osmosis. It should contain less than a mg of elements other than water per 100 ml. Versions with agents that stop bacterial growth are also available
",,,,,,,,,,,,,3
+1166,Warfarin Sodium,warfarin-sodium-1166,https://medex.com.bd/attachments/pw4w0Bl0CevTA70gzN3Fv38ApuGGty/warfarin-sodium-prescribing-information,Oral Anti-coagulants,Venous thromboembolism,"Warfarin is indicated in the following conditions-
+
+- Prophylaxis and/or treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement
+- Indicated to reduce the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction
... Read more
Warfarin is indicated in the following conditions-
+
+- Prophylaxis and/or treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement
+- Indicated to reduce the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction
+- Prophylaxis and treatment of venous thrombosis and pulmonary embolism
+- Transient ischaemic attacks.
+
","Anti-coagulants, Oral Anti-coagulants
","Warfarin is a [vitamin K] antagonist which acts to inhibit the production of vitamin K by vitamin K epoxide reductase. The reduced form of vitamin K, vitamin KH2 is a cofactor used in the γ-carboxylation of coagulation factors VII, IX, X, and thrombin. Carboxylation induces a conformational change allowing the factors to bind Ca2+ and to phospholipid surfaces. Uncarboxylated factors VII, IX, X, and thrombin are biologically inactive and therefore serve to interrupt the coagulation cascade. The endogenous anticoagulation proteins C and S also require γ-carboxylation to function. This is particularly true in the case of thrombin which must be activated in order to form a thrombus. vitamin KH2 is converted to vitamin K epoxide as part of the γ-carboxylation reaction catalyzed by γ-glutamyl carboxylase. Vitamin K epoxide is then converted to vitamin K1 by vitamin K epoxide reductase then back to vitamin KH2 by vitamin K reductase. Warfarin binds to vitamin K epoxide reductase complex subunit 1 and irreversibly inhibits the enzyme thereby stopping the recycling of vitamin K by preventing the conversion of vitamin K epoxide to vitamin K1. This process creates a hypercoagulable state for a short time as proteins C and S degrade first with half lives of 8 and 24 hours, with the exception of factor VII which has a half life of 6 hours. Factors IX, X, and finally thrombin degrade later with half lives of 24, 36, and 50 hours resulting in a dominant anticoagulation effect. In order to reverse this anticoagulation vitamin K must be supplied, either exogenously or by removal of the vitamin K epoxide reductase inhibition, and time allowed for new coagulation factors to be synthesized. It takes approximately 2 days for new coagulation factors to be synthesized in the liver. Vitamin K2, functionally identical to vitamin K1, is synthesized by gut bacteria leading to interactions with antibiotics as elimination of these bacteria can reduce vitamin K2
","Whenever possible, the baseline prothrombin time should be determined but the initial dose should not be delayed whilst awaiting the result.
Use in adults: The usual adult induction dose of warfarin is 10 mg daily for 2 days. The subsequent maintenance dose depends upon the prothrombin time, reported as INR (international normalized ratio). The daily maintenance dose of warfarin is usually 3 to 9 mg (taken at the same time each day). The maintenance dose is omitted if the prothrombin time is excessively prolonged. Once the maintenance dose is established in the therapeutic range, it is rarely necessary to alter. In emergencies, anticoagulant therapy should be initiated with heparin and warfarin together. Where there is less urgency, as in patients disposed to or at special risk of thromboembolism, anticoagulant therapy may be initiated with warfarin alone. Control tests must be made at regular intervals and maintenance dosage further adjusted according to the results obtained.
Use in children: Safety and efficacy in children <18 years old have not been established. However, there is evidence of use and the initial dose is usually 0.1 mg.kg-1.d-1 adjusted subsequently to aim for an INR range the same as in adults.
",,"Oral anticoagulants have a greater potential for clinically significant drug interactions. Warn all patients about potential hazards and instruct against taking or withdrawing any drug, including non-prescription products, without the advice of a physician.
","Warfarin can not be administered in the following cases;
+
+- Actual or potential hemorrhagic conditions, eg. Peptic ulcer, or to patients with uncontrolled hypertension
+- Severe hepatic or renal disease
+- Pregnancy
+- Known hypersensitivity to warfarin
+- Bacterial endocarditis
+
+Its use within 24 hours following surgery or labor should be undertaken with caution, if at all.
","Hemorrhage is the principal adverse effect of oral anticoagulants. Other adverse reactions include nausea, vomiting, diarrhea, hypersensitivity, rash, alopecia, and unexplained drop in haematocrit, ""purple toes"", skin necrosis, jaundice, and hepatic dysfunction.
","Warfarin is contraindicated in the first trimester of pregnancy because of the risk of teratogenicity. It should not be used in women who are or may become pregnant because the drug passes through the placental barrier and may cause fatal hemorrhage to the fetus. Warfarin appears in the milk of nursing mothers in an inactive form. Infants nursed by mothers treated with Warfarin had no change in prothrombin times. Effects in premature infants have not been evaluated.
","Periodic determination of prothrombin time (PT)/international normalized ratio (INR) or other suitable coagulation test is essential. Numerous factors, alone or in combination, including travel, changes in diet, environment, physical state and medication may influence response of the patient to anticoagulants. It is generally good practice to monitor the patient's response with additional PT/INR determination in the period immediately after discharge from the hospital, and whenever other medications are initiated, discontinued or taken irregularly. The following factors may exaggerate the effects of warfarin and necessitate a reduction in dosage; loss of weight, elderly subject, acute illness, deficient renal function, decreased dietary intake of vitamin K, administration of certain drugs (see drug interaction). Factors which may call for an increase in maintenance dosage include weight gain, diarrhea and vomiting, increased intake of vitamin K, fats and oils, and the administration of certain drugs. Careful additional laboratory control is necessary if the patient is to be changed from one formulation to another. Reversal of warfarin anticoagulation by vitamin K takes several days. In emergency situations fresh frozen plasma should be given.
",,"If hemorrhage occurs or a potential bleeding state arises, excessive depression of the coagulation activity can be corrected by temporary withdrawal of warfarin accompanied, if necessary, by infusion of fresh-frozen plasma or whole blood. Vitamin K, 5 mg to 10 mg orally or intravenously, may be required to supplement specific treatment with co-factor concentrates.
",,,"Do not store above 30°C. Keep away from light and out of the reach of children.
",11
+1238,Voriconazole,voriconazole-1238,https://medex.com.bd/attachments/O6QLXQaKIzGSfWVfrkuCTxko9Myz5t/voriconazole-prescribing-information,Other Antifungal preparations,Scedosporiosis and fusariosis,"Voriconazole is an azole antifungal medicine. It is indicated for use in patients 12 years of age and older in the treatment of following fungal infections-
+
+- Invasive aspergillosis
+- Candidemia (nonneutropenic) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds
... Read more
Voriconazole is an azole antifungal medicine. It is indicated for use in patients 12 years of age and older in the treatment of following fungal infections-
+
+- Invasive aspergillosis
+- Candidemia (nonneutropenic) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds
+- Esophageal candidiasis
+- Serious infections caused by Scedosporium apiospermum and Fusarium Species including Fusarium solani
+- Patients intolerant of, or refractory to other therapy.
+
","Other Antifungal preparations
","Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.
","Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
+
+- At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
+- Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.
+
+
Injection-
Invasive Aspergillosisd :
+
+- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
+- Maintenance Dose: 4 mg/kg 12 hourly.
+
+Candidemia in nonneutropenic patients and other deep tissue Candida infections:
+
+- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
+- Maintenance Dose: 3-4 mg/kg 12 hourly.
+
+Scedosporiosis and Fusariosis:
+
+- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
+- Maintenance Dose: 4 mg/kg 12 hourly.
+
",,"
+- CYP3A4, CYP2C9 and CYP2C19 inhibitors and inducers: Adjust Voriconazole dosage and monitor for adverse reactions or lack of efficacy
+- Voriconazole may increase the concentrations and activity of drugs that are CYP3A4, CYP2C9 and CYP2C19 substrates. Reduce doses of these other drugs and monitor for adverse reactions
+- Increase maintenance oral and intravenous dosage of Voriconazole with co-administration of Phenytoin or Efavirenz
+
","Known hypersensitivity to Voriconazole or any other components of this drug-
+
+- Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
+- Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy
+
","The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.
","There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
","Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.
","The efficacy to the children under 12 years of age is not established.
","There is no data found about overdose of Voriconazole.
",,"Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.
","Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.
",13
+1266,Voglibose,voglibose-1266,,Alpha-Glucosidase inhibitor,Type 2 DM,"Voglibose is used in diabetes mellitus (DM) for reduction in Post-Prandial Hyperglycaemia (PPHG), only when diet and/or exercise with lifestyle modification or Oral Hypoglycaemic Agents (OHAs) or insulin preparations, in addition to diet and/or exercise, do not result in an adequate glycaemic control ... Read more
Voglibose is used in diabetes mellitus (DM) for reduction in Post-Prandial Hyperglycaemia (PPHG), only when diet and/or exercise with lifestyle modification or Oral Hypoglycaemic Agents (OHAs) or insulin preparations, in addition to diet and/or exercise, do not result in an adequate glycaemic control.
Thus, Voglibose is indicated:
+
+- In non-insulin-dependent diabetes mellitus (NIDDM) patients as immunotherapy
+- In combination with other OHAs
+- In addition to insulin in diabetes mellitus patients
+- In prevention of onset of type 2 diabetes mellitus in impaired glucose tolerance (only for Voglibose 0.2 mg Tablets) (However, Voglibose Tablets should be used only when impaired glucose tolerance has not been improved in patients already undergoing appropriate dietary treatment and/or exercise therapy.)
+- In elderly patients and in those with hepatic dysfunction or mild to moderate renal impairments in whom other OHAs are contraindicated or they need to be used with caution, Voglibose will be helpful.
+- In glycogen storage disease: Voglibose is helpful in prevention of hypoglycaemia in patients with type lb glycogen storage disease, it being an amylase (a glucosidase) inhibitor.
+- In non-diabetic Hyperinsulinemia, Voglibose is helpful in preventing hypoglycaemic attacks.
+- In steroid induced diabetes mellitus also, Voglibose is helpful. However, clinical data in this setting are limited.
+
","Alpha-Glucosidase inhibitor
","Alpha-glucosidase inhibitors are saccharides that act as competitive inhibitors of enzymes needed to digest carbohydrates: specifically alpha-glucosidase enzymes in the brush border of the small intestines. The membrane-bound intestinal alpha-glucosidases hydrolyze oligosaccharides, trisaccharides, and disaccharides to glucose and other monosaccharides in the small intestine. Acarbose also blocks pancreatic alpha-amylase in addition to inhibiting membrane-bound alpha-glucosidases. Pancreatic alpha-amylase hydrolyzes complex starches to oligosaccharides in the lumen of the small intestine. Inhibition of these enzyme systems reduces the rate of digestion of complex carbohydrates. Less glucose is absorbed because the carbohydrates are not broken down into glucose molecules. In diabetic patients, the short-term effect of these drugs therapies is to decrease current blood glucose levels: the long term effect is a small reduction in hemoglobin-A1c level.
","Normal Adult Dose: Usually, Voglibose tablets are orally administered in a single dose of 0.2 mg, 3 times a day, before each meal. If the effect is not sufficient, the quantity of a single dose may be increased up to 0.3 mg.
Pediatrics: The safety and effectiveness of Voglibose in children has not been established.
Geriatrics: Since elderly patients generally have a physiological hypofunction, it is desirable that such caution be taken as starting the administration at a lower dose (eg, 0.1 mg at a time). Furthermore, this drug should be carefully administered under close observation, through the course of the disease condition, with careful attention to the blood sugar level and the onset of gastrointestinal symptoms.
",,"Voglibose should be administered with care when co-administered with the following drugs:
Antidiabetic drugs: Derivative(s) of sulfonylamide and sulfonylurea, biguanide derivatives, insulin preparations and improving agents for insulin resistance.
For the concomitant use of antldlabetlc drugs and the drugs which enhance or diminish the hypoglycaemic action of antldlabetlc drugs:
+
+- Drugs enhancing the hypoglycaemic action of antidiabetic drugs: β-blockers, salicylic acid preparations, monoamine oxidase inhibitors, fibrate derivatives for the treatment of hyperlipemia, warfarin, etc.
+- Drugs diminishing the hypoglycemic actton of antidiabetic drugs: Adrenaline, adrenocortical hormone, thyroid hormone, etc.
+
","Contraindicated in patients with Hypersensitivity to Voglibose or to any of the excipients; Diabetic ketoacidosis, diabetic pre-coma; Severe infection, before and after operation or with serious trauma; Gastrointestinal obstruction or predisposed to it.
","Diarrhoea, loose stools, abdominal pain, constipation, loss of appetite, urge to vomit (nausea), vomiting, heartburn, increased gas, and intestinal obstruction like symptoms due to increased intestinal gas. OHAs plus voglibose may cause hypoglycaemia (0.1% to <5%), delay in digestion and absorption of disaccharides, fulminant hepatitis, serious liver dysfunction with increased liver enzymes, jaundice, anaemia, numbness, edema, blurred vision, hot flushes, malaise, weakness, hyperkalemia, increased pancreatic enzyme (serum amylase).
","Pregnancy: The safety of Voglibose in pregnancy has not been established. However, no adequate and well controlled studies have been done on pregnant women.
Lactatlng and Nursing Mothers: Although the levels of Voglibose reached in human milk are exceedingly low, it is recommended that Voglibose may not be administered to such women.
","Careful Administration (should be administered with care in following patients):
+
+- Patients who are receiving other antidiabetic drugs as hypoglycaemia may occur
+- Patients with a history of laparotomy or ileus (intestinal obstruction-like symptoms are liable to develop due to an increase in intestinal gas, etc.)
+- Patients with chronic intestinal disease accompanied by a disturbance in digestion and absorption (the action of this drug may aggravate the pathologic conditions)
+- Patients with Roemheld’s Syndrome, severe hernia, Stenosis or ulceration of the large intestine, etc. (Symptoms may worsen due to an increase in the intestinal gas, etc.)
+- Patients with serious hepatic dysfunction (Because of possible changes in metabolic condition, the status of plasma glucose control may greatly vary. In patients with severe liver cirrhosis, hyperammonemia may worsen, followed by disturbance of consciousness.)
+- Patients with serious renal dysfunction (Because of possible changes in metabolic conditions, the status of plasma glucose control may greatly vary.)
+- Elderly patients
+
","Dosage in Renal Failure: Voglibose is poorly absorbed after oral doses and renal excretion is negligible, suggesting that no dose adjustment is required. However, pharmacokinetic studies in patients with renal insufficiency are not available.
","Unlike sulfonylureas or insulin, an overdose of Voglibose tablets will not result in hypoglycaemia. An overdose may result is transient increase in flatulence, diarrhoea and abdominal discomfort. Because of lack of extra-intestinal effects soon with Voglibose, no serious systemic reactions are expected in the event of an overdose.
",,,"Keep in a cool and dry place. Keep out of the reach of children. Protect from light.
",12
+1872,"vitamins [C, E, B9 and B12] and minerals [Selenium, Copper and Zinc]",vitamins-c-e-b9-and-b12-and-minerals-selenium-copper-and-zinc-1872,,Supplements & adjuvant therapy,Antioxidant,"Helps to protect cells against oxidative stress.
","Supplements & adjuvant therapy
",,"1 tablet per day during 3 to 6 months
",,,"Hypersensitivity to the active substance or to any of the excipients.
",,,,,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",5
+1136,"Vitamin C, Vitamin E, Lutein, Copper & Zinc",vitamin-c-vitamin-e-lutein-copper-zinc-1136,,Anti-oxidant Multivitamin Multimineral preparations,Vitamin or mineral deficiency,"This preparation is indicated for Age-related Eye Disease. This is an advanced new antioxidant supplement formulated to provide nutritional support for the eye. The formulation contains essential antioxidant vitamins, minerals, and Lutein.
","Anti-oxidant Multivitamin Multimineral preparations, Antioxidant vitamins & minerals for eye
","Vitamin C is highly concentrated in the lens compared to blood. A long term Vitamin C supplement use (10+ years) has been associated with reduced risk of cataract. Vitamin C has an important role in harmful free radicals scavenging activity.
In study, it is found that high serum Vitamin E concentrations have been associated with reduced risk of cataract (exact mechanism of action is not still established). As an antioxidant vitamin, it also plays an important role in harmful free radicals scavenging activity.
Lutein is a carotenoid, specially concentrated in the macula. Clinical and animaldata indicates that this caretenoid could protect the macula from oxidative or light damage.
Although exact mechanism of action is not clear but onelarge study has found that high levels of dietary Lutein is associated with relatively lower risk of AMD (Age-Related Macular Degeneration). Zinc is an essential trace element involved in many enzymes system.
Symptoms of less severe deficiency include distorted or absent perception of taste, smell and poor wound healing. Severe deficiency causes skin lesion, alopecia, diarrhea, increased susceptibility to infection and failure to thrive in children.
Copper plays important role in growth, skeletal integrity, and development of nervous system. As a part of various enzymes, it takes part in numerous metabolic conversions.
","One capsule, one or two times daily or as directed by the physician
",,"No drug interaction has been reported.
","It is contraindicated in persons with a history of hypersensitivity to any of its ingredients.
","Large doses of Vitamin C are reported to cause diarrhoea and other gastrointestinal disturbances. Large doses of Vitamin E may cause diarrhoea, abdominal pain, and other gastrointestinal disturbances; fatigue and weakness have also been reported. Side effects of Zinc salt are abdominal pain and dyspepsia.
","Recommended in Pregnancy & Lactation.
","Vitamin C should be given with care to patients with hyperoxaluria. In patients taking oral anticoagulants or oestrogen, Vitamin E should be given carefully because it has been found to antagonise the effects of vitamin K leading to an increase in blood clotting time in these patient
",,,,,"Store in a dry place below 25° C. Protect from light.
",10
+1162,Vitamin C + Vitamin E,vitamin-c-vitamin-e-1162,,Anti-oxidant Multivitamin preparations,Vitamin C deficiency,"Keratosis, Rough skin,Wrinkles associated with aging, Alzheimer's disease, Cancer Prevention, dementia, degenerative diseases, coronary heart diseases, end stage renal disease, growth and repair of body tissue, bone, skin, teeth and hair.
","Anti-oxidant Multivitamin preparations, Specific combined vitamin preparations
","Vitamin C: Necessary for collagen formation and tissue repair; plays a role in oxidation/reduction reactions as well as other metabolic pathways including synthesis of catecholamines, carnitine, and steroids; also plays a role in conversion of folic acid to folinic acid.
Vitamin E plays a role in protecting red blood cells against hemolysis; has protective effects against free radicals on polyunsaturated fatty acids found in cell membranes; plays a role in preventing oxidation of vitamin A and C.
","One tablet or capsule daily or as directed by a physician.
",,"Vitamin C: Deferroxamine, hormonal contraceptives, flufenazine, warfarin, elemental iron, salicylates, warfarin, fluphenazine, disulfiram, mexiletine, vitamin B12.
Vitamin E: Colestyramine, colestipol, and orlistat may interfere with vitamin E absorption. High doses of vitamin E potentiates the anticoagulant action of warfarin. Large doses of vitamin E may impair response to iron supplementation.
","Patients with a known hypersensitivity to any of the ingredients.
","Generally, this preparation is well-tolerated. Diarrhea may occasionally occur during treatment with beta carotene and the skin may assume a slightly yellow discoloration. The side-effects of vitamin A are reversible. Vitamin C and vitamin E may cause diarrhea and other gastrointestinal disturbances.
","Pregnancy Category A. Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
","Hypervitaminosis. Avoid use in early pregnancy. Patients on anti coagulant therapy should not use ascorbic acid prolonged period of time.
",,,,,,9
+496,Vitamin C + Vitamin D3 + Folic acid,vitamin-c-vitamin-d3-folic-acid-496,,Specific combined vitamin preparations,"Vitamin B,Vitamin-C and Folic acid deficiencies","Calcium and Vitamin-D is used for the treatment of osteoporosis, osteomalacia, rickets, tetany, and parathyroid disease. Also used in raised calcium requirement for children and adolescents at times of rapid growth, inadequate intake of calcium in the diet due to malnutrition, prevention and treatment ... Read more
Calcium and Vitamin-D is used for the treatment of osteoporosis, osteomalacia, rickets, tetany, and parathyroid disease. Also used in raised calcium requirement for children and adolescents at times of rapid growth, inadequate intake of calcium in the diet due to malnutrition, prevention and treatment of osteoporosis, disorders of osteogenesis and tooth formation (in addition to specific treatment), latent tetany and during pregnancy and lactation. It is also used as routine supplement and phosphate binder in chronic renal failure.
","Specific combined vitamin preparations
","Ascorbic acid (vitamin C) & Folic acid (also known as Vitamin B9) are water-soluble vitamins. Vitamin D is fat-soluble. Ascorbic acid helps integration & cohesiveness of cells by synthesizing collagen which is also known as biological glue. It is also a powerful antioxidant in the aqueous media. Vitamin D is also known as antirachitic and sun-shine vitamin which displays its roles like a hormone (pro-hormone). Vitamin D spares calcium in the body by reducing excretion and enhancing calcium absorption. Folic acid is crucial for proper brain function and plays an important role in mental and emotional health. It aids in the production of DNA and RNA, the body's genetic material, and is especially important during periods of high growth, such as infancy, adolescence and pregnancy. It controls blood levels of the amino acid Homocysteine. Elevated levels of this substance appear to be linked to certain chronic conditions such as heart disease. Indications: Deficiency states of Vitamin C, Vitamin D and Folic acid associated with cardiovascular diseases, Deficiency states of Vitamin-C (Scurvy, generalized weakness, gum bleeding, after acute infections, alcoholism and postoperatively), Wound healing, Prevention of cold, flue and influenza, Megaloblastic anemia and anemia of nutritional origin, Deficiency states of Vitamin-D (Intestinal malabsorption, chronic liver disease, osteomalacia, osteopenia, rickets, hypocalcemia, institutionalized patients, persons who use sunscreen, black people, person who covers most of the body surface due to cultural and religious purpose). Familial hypophosphatemia, Hypoparathyroidism, As adjuvant with calcium supplement, Prevention of osteoporosis and fracture alone or in combination with calcium supplement, Conditions where demand for Vitamin-C, Vitamin-D and Folic acid increases (pregnancy, lactation, smoking and old age, person living in polluted environment).
","One tablet twice daily with food or as directed by the physician.
",,"Concurrent administration of Thiazide diuretics may increase the risk of hypercalcemia. Calcium salts reduce the absorption of a number of other drugs such as Biphosphonates, Fluoride, some Fluoroquinolones and Tetracyclines.
","
+- Hypercalcemia and hyperparathyroidism
+- Hypercalciuria and nephrolithiasis
+- Hypersensitivity to the component of this preparation
+- Severe renal insufficiency
+- Concomitant digoxin therapy(requires careful monitoring of serum calcium level)
+
","Vitamin C, Vitamin D3 & Folic acid combination is well tolerated. Mild gastrointestinal disturbances may occur.
","Pregnancy: There is no contraindication to the use of this preparation in pregnancy.
Lactation: There is no contraindication to the use of this preparation in Lactation. Contraindications: This combination is contraindicated in hypercalcemia, hyperparathyroidism, renal calculi, nephrolithiasis, Zoolinger-Ellison syndrome, concomitant Digoxin therapy (requires careful monitoring of serum calcium level).
","Caution should be taken in patients with Renal impairment, Sarcoidosis, Hypercalcemia and Hypercalciuria, Cardiac disease.
",,"Over dosage: If over dosage occurs, therapy should be immediately stopped.
",,,,10
+1137,Vitamin C [Ascorbic acid],vitamin-c-ascorbic-acid-1137,,Vitamin-C Preparations,Vitamin C deficiency,"Vitamin C is indicated for prevention and treatment of scurvy. It may be indicated in pregnancy, lactation, infection, trauma, burns, cold exposure, following surgery, fever, stress, peptic ulcer, cancer, methaemoglobinaemia and in infants receiving unfortified formulas. It is also prescribed for haematuria ... Read more
Vitamin C is indicated for prevention and treatment of scurvy. It may be indicated in pregnancy, lactation, infection, trauma, burns, cold exposure, following surgery, fever, stress, peptic ulcer, cancer, methaemoglobinaemia and in infants receiving unfortified formulas. It is also prescribed for haematuria, dental caries, pyorrhea, acne, infertility, atherosclerosis, fractures, leg ulcers, hay fever, vascular thrombosis prevention, levodopa toxicity, succinyl-choline toxicity, arsenic toxicity etc. To reduce the risk of stroke in the elderly, long-term supplementation with Vitamin C is essential.
","Vitamin-C Preparations
","vitamin C, the water-soluble vitamin, is readily absorbed from the gastrointestinal tract and is widely distributed in the body tissues. It is believed to be involved in biological oxidations and reductions used in cellular respiration. It is essential for the synthesis of collagen and intracellular material. Vitamin C deficiency develops when the dietary intake is inadequate and when increased demand is not fulfilled. Deficiency leads to the development of well defined syndrome known as scurvy, which is characterized by capillary fragility, bleeding (especially from small blood vessels and the gums), anaemia, cartilage and bone lesions and slow healing of wounds.
","Oral administration-
+
+- For the prevention of scurvy: 1 tablet daily
+- For the treatment of scurvy: 1-2 tablets daily; but dose may be increased depending on the severity of the condition.
+- For the reduction of risk of stroke in the elderly: 1-2 tablets daily.
+- In other cases: 1 tablet daily or as directed by the physician.
+- Maximum safe dose is 2000 mg daily in divided doses.
+
+Parenteral administration-
+
+- Vitamin C is usually administered orally. When oral administration is not feasible or when malabsorption is suspected, the drug may be administered IM, IV, or subcutaneously. When given parenterally, utilization of the vitamin reportedly is best after IM administration and that is the preferred parenteral route.
+- For intravenous injection, dilution into a large volume parenteral such as Normal Saline, Water for Injection, or Glucose is recommended to minimize the adverse reactions associated with intravenous injection.
+- The average protective dose of vitamin C for adults is 70 to 150 mg daily. In the presence of scurvy, doses of 300 mg to 1 g daily are recommended. However, as much as 6 g has been administered parenterally to normal adults without evidence of toxicity.
+- To enhance wound healing, doses of 300 to 500 mg daily for a week or ten days both preoperatively and postoperatively are generally considered adequate, although considerably larger amounts have been recommended. In the treatment of burns, doses are governed by the extent of tissue injury. For severe burns, daily doses of 1 to 2 g are recommended. In other conditions in which the need for vitamin C is increased, three to five times the daily optimum allowances appear to be adequate.
+- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.
+
",,"Potentially hazardous interactions: Ascorbic acid is incompatible in solution with aminophylline, bleomycin, erythromycin, lactobionate, nafcillin, nitrofurantoin sodium, conjugated oestrogen, sodium bicarbonate, sulphafurazole diethanolamine, chloramphenicol sodium succinate, chlorthiazide sodium and hydrocortisone sodium succinate.
Useful interactions: Ascorbic acid increases the apparent half-life of paracetamol and enhances iron absorption from the gastrointestinal tract.
",,"Vitamin C has little toxicity and only mega-doses of vitamin C may cause diarrhoea, abdominal bloating, iron over-absorption that is harmful in patients with thalassaemia, sideroblastic anemia, and haemochromatosis; hyperoxaluria, hyperuricosuria, and hemolysis in patients with glucose-6 phosphate dehydrogenase deficiency. A pregnant woman taking more than 5 gm/day may suffer fetal abortion.
","The drug is safe in normal doses in pregnant women, but a daily intake of 5 gm or more is reported to have caused abortion. The drug may be taken safely during lactation.
","Ingestion of megadose (more than 1000 mg daily) of vitamin C during pregnancy has resulted in scurvy in neonates. Vitamin C in mega-doses has been contraindicated for patients with hyperoxaluria. Vitamin C itself is a reactive substance in the redox system and can give rise to false positive reactions in certain analytical tests for glucose, uric acid, creatine and occult blood.
",,,,,"Should be stored in a dry place below 30˚C.
",9
+497,"Vitamin B6, B9 & B12",vitamin-b6-b9-b12-497,,Specific combined vitamin preparations,Vitamin B deficiencies,"This tablets are indicated for the distinct nutritional requirements of individuals under a physician's treatment for hyperhomocysteinemia; nutrient malabsorption or inadequate dietary intake; with particular emphasis for individuals with or at risk for atherosclerotic vascular disease in the coronary, peripheral, or cerebral vessels, or neurological disorders.
","Specific combined vitamin preparations, Vitamin-B preparations
","Pyrodoxine (Vitamin B6) is a water-soluble vitamin which functions in the metabolism of carbohydrates, proteins and fats. It is essential in Hb formation and GABA synthesis within the CNS. It also aids in the release of glycogen stored in the liver and muscles.
Folic acid (Vitamin B9) is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. It is also essential in the synthesis and maintenance of nucleoprotein in erythropoesis. It also promotes WBC and platelet production in folate-deficiency anaemia.
Cyanocobalamin (Vitamin B12) is vital to growth, hematopoiesis and nucleoprotein and myelin synthesis. As a hematopoietic agent, it is converted to coenzyme B12 needed in the conversion of methylmalonate to succinate and production of methionine from homocysteine, a reaction requiring folate. In the absence of folate, such metabolites cannot be formed and folate deficiency occurs. It is also involved in the maintenance of reduced sulfhydryl (SH) groups which are required by various SH-activated enzyme systems. Through such processes, cyanocobalamin participates in fat and carbohydrate metabolism as well as protein synthesis.
","Usual adult dose is one to two tablets daily or as directed by a physician.
",,"Pyridoxine Hydrochloride should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by Pyridoxine Hydrochloride. However; Pyridoxine Hydrochloride may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folic acid may result in decreased phenytoin effectiveness.
","Known hypersensitivity to any of the components in the product is a contraindication.
","Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Paresthesia, somnolence, nausea and headache have been reported with pyridoxine hydrochlloride. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema, and the feeling of swelling of the entire body has been associated with cyanocobalamin.
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","Pregnancy category- Not classified
","Folic acid when administered as a single agent in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Unmetabolized Folic Acid has the potential to reduce natural killer cells cytotoxicity, which may result in an impaired immune response.
",,,,,,9
+307,Vitamin B12 + Elemental Iron + Folic Acid,vitamin-b12-elemental-iron-folic-acid-307,,Iron & Vitamin Combined preparations,Megaloblastic anaemia,"This is indicated for the prevention and treatment of Iron, vitamin B12 and Folic acid deficiency. Also indicated for the prevention of Iron deficiency during pregnancy and lactation and as prophylactic therapy of Iron deficiency to cover the recommended daily dietary allowance.
","Iron & Vitamin Combined preparations
","Vitamin B12 (cyanocobalamin): Required for the maintenance of normal erthropoiesis, nucleprotein and myelin synthesis, cell reproduction and normal growth; Coenzyme; metabolic functions include protein synthesis and carbohydrate metabolism. Plays role in cell replication and hematopoiesis.
Iron: Essential component in the formation of hemoglobin; adequate amounts of iron are necessary for effective erythropoiesis; also serves as a cofactor of several essential enzymes, including cytochromes that are involved in electron transport. Replacement of iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin.
Folic acid: Required for nucleoprotein synthesis and the maintenance of normal erythropoiesis; folic acid is converted in the liver and plasma to its metabolically active form, tetrahydrofolic acid, by dihydrofolate reductase; prevents neural tube defects in women of childbearing potential and higher doses required during pregnancy.
","Adult: 1-2 capsules daily; as recommended by the physician.
Children: 1 capsule daily; as recommended by the physician.
Infant: As recommended by the physician.
",,"Generally no interactions have been observed. Iron may decrease the absorption of antacids, tetracycline, quinolone antibiotics, levodopa, levothyroxine, methyldopa and pencillamine. Folic acid interacts with antiepileptic drugs, no plasma concentrations of Phenobarbital, phenytoin possibly reduced.
","Contraindicated in patients with known hypersensivity to any of its ingredients.
","Generally well tolerated. In individual cases, a few side-effects occur to oral Iron preparation, such as nausea, vomiting, constipation or diarrhoea.
","This preparation can be used in pregnancy and lactation.
","Caution should be applied where there is a risk of Iron overload, e.g. Haemochromatosis, Thalassaemia, Haemosiderosis or Haemolytic anaemia.
",,"Initially epigastric pain, diarrhea and vomiting can occur of overdose. Metabolic acidosis, convulsions and coma can occur after recovery. In case of overdose an emetic should be given followed by gastric lavage and general supportive measures.
",,,"Store in cool and dry place. Protect from light.
",11
+1042,"Vitamin B1, B2 & B6",vitamin-b1-b2-b6-1042,,Specific combined vitamin preparations,Vitamin B deficiencies,"It is indicated for supportive nutritional supplementation in conditions in which these vitamins are required. These include conditions causing depletion, or reduced absorption or bioavailability of vitamins such as gastrointestinal disorders, chronic alcoholism, febrile illness, prolonged or wasting ... Read more
It is indicated for supportive nutritional supplementation in conditions in which these vitamins are required. These include conditions causing depletion, or reduced absorption or bioavailability of vitamins such as gastrointestinal disorders, chronic alcoholism, febrile illness, prolonged or wasting diseases, hyperthyroidism or poorly controlled diabetes and conditions resulting in increased need for vitamins like pregnancy, severe burns, recovery from surgery. It is also used in beri-beri, peripheral neuritis, Wernicke’s encephalopathy, impaired digestion of starch and sugar due to thiamine deficiency, cheilosis, angular stomatitis, glossitis, keratitis, seborrhoeic dermatitis, photophobia and corneal vascularization.
","Specific combined vitamin preparations, Vitamin-B preparations
","Thiamine (Vitamin B1) forms thiamine pyrophosphate by combining with adenosine triphosphate; essential coenzyme in carbohydrate metabolism.
Riboflavin (vitamin B2) is required for energy utilisation from food. It is essential for normal tissue respiration. It is also necessary for the activation of pyridoxine and conversion of tryptophan to nicotinic acid.
Pyridoxine (vitamin B6) is a water-soluble vitamin which functions in the metabolism of carbohydrates, proteins and fats. It is essential in Hb formation and GABA synthesis within the CNS. It also aids in the release of glycogen stored in the liver and muscles.
","Adults: 2 ml every day or alternate days intravenously or intramuscularly.
",,"Pyridoxine may increase the peripheral metabolism of levodopa, reducing therapeutic efficacy in patients with Parkinson’s disease.
","Hypersensitivity to any of its components.
","Adverse reactions have been reported with specific vitamins, and generally at levels substantially higher than those in Vitamin B1, B2 & B6. However, allergic and idiosyncratic reactions are possible at lower levels.
","The recommended dose should not be exceeded without medical advice.
","It should be given cautiously to patients taking levodopa as pyridoxine reduces the effect of levodopa. Hypersensitivity may develop in patients previously given thiamine, specially after repeated injections of concentrated solution; give subsequent injections with care. Discontinue drug if untoward reactions develop. Intramuscular administration may cause transient pain; when used undiluted, administer slowly.
",,,,,"Store below 25°C in a dry place, away from light.
",10
+1135,"Vitamin B1, B6 & B12",vitamin-b1-b6-b12-1135,,Specific combined vitamin preparations,Vitamin B deficiencies,"Vitamin B1, B6 & B12 is indicated for the treatment of vitamin B1, B6 & B12 deficiency syndrome. It is also indicated for the supportive treatment of neuritis & non-inflammatory diseases of the nerves, e.g.- Diabetic neuropathy, Peripheral neuralgin, Lumbago, Myalgia, Optic neuritis, Sciatica, Facial neuralgia, Intercostal neuralgia, Spinal pain.
","Specific combined vitamin preparations
","Vitamin B1 converts carbohydrates, fatty acids and amino acids into energy, promotes healthy nerves, improves mood, strengthens the heart. Vitamin B6 forms RBCs, helps cells to make proteins, manufactures neurotransmitters e.g. serotonin and releases stored forms of energy, helps to prevent CVS diseases and stroke, helps to lift depression and eases insomnia. Vitamin B12 is essential for cell replication and important for RBC production, prevents anemia, helps to prevent depression, reduces nerve pain, numbness, tingling and lowers the risk of heart diseases.
The vitamin ingredients are absorbed well in per oral reception. It is widely distributed to most tissues and appears in breast milk. Within the cell, thiamine is mostly present as diphosphate. Thiamine is not stored to any appreciable extent in the body and amounts in excess of the body’s requirements are excreted in the urine as unchanged thiamine or as metabolites. Pyridoxine, pyridoxal and pyridoxamine are readily absorbed from the GIT following oral administration and are converted to the active forms of pyridoxal phosphate an pyridoxamine phosphate. They are stored mainly in liver where there is oxidation to 4-pyridoxic acid and other inactive metabolites, which are excreted in urine. As the dose increases, proportionally greater amounts are excreted unchanged in the urine.
","Tablet: 1-3 Tablets per day or as advised by the physician.
Injection:
+
+- In severe (acute) cases: 1 injection daily until the acute symptoms subside or taken as advised by the physician.
+- In mild cases: 1 injection 2-3 times per week. Ampoules are preferably injected intramuscularly.
+
+Use in children: There is no information on the use of this drug in children.
",,"No drug interaction has been reported yet.
","Vitamin B1, Vitamin B6 and Vitamin B12 is contraindicated in patients on levodopa therapy, and in patients with hypersensitivity to any of the ingredients of the preparation.
","Generally well tolerated but allergic reactions may be observed in few cases.
","Oral tablet form is recommended but due to the presence of benzyl alcohol, injection is not recommended during pregnancy & lactation.
","Cyanocobalamin should not be given in patients with subacute degeneration of the spinal cord. Cyanocobalamin is not suitable form of vitamin B12 for the treatment of optic neuropathies associated with raised plasma concentrations of cyanocobalamin.
",,"No overdosage symptoms are to be expected in the recommended dosage. If there is known overdose then treatment is symptomatic & supportive.
",,,"Keep out of reach of children. Store in a cool (below 25°C temperature) and dry place, protected from light.
",11
+1133,Vitamin B Complex + Zinc,vitamin-b-complex-zinc-1133,,Specific mineral & vitamin combined preparations,Vitamins B and Zinc deficiencies,"This is indicated for the treatment and prevention of zinc and vitamin B deficiencies.
","Specific mineral & vitamin combined preparations
","Zinc is vital for many biological functions such as immunity enhancement, wound healing, digestion, reproduction, physical growth and mental development. Zinc supports normal growth and development during pregnancy, childhood, and adolescence. Zinc also has some antioxidant properties. Zinc is used to treat ADHD (Attention Deficit Hyper-activity Disorder) in children. In adult, due to zinc deficiency loss of appetite, poor sense of taste and smell, tendency towards depression, white marks on fingernails, frequent infections, low fertility, prostate problems, mental problems, poor wound healing, a poor immune system, diarrhoea, mental lethargy, rough skin and weight loss may occur.
B-Vitamins are needed to release energy from food. They play an important role in ensuring healthy brain and nerve function, healthy red blood cells formation in children & adults. They are specially needed for healthy growth and development of children. B-Vitamin deficiencies in adult cause profound fatigue and various types of neurologic manifestations, which may include weakness, poor balance, confusion, irritability, memory loss, nervousness, tingling of the limbs and loss of coordination. Additional symptoms of vitamin B deficiency are sleep disturbances, nausea, poor appetite, frequent infections, and skin lesions.
","Syrup-
+
+- Adults: 10 ml (2 teaspoonful) 2 to 3 times daily or as recommended by the physician.
+- Children: 10 ml (2 teaspoonful) 1 to 3 times daily or as recommended by the physician.
+- Infants: 5 ml (1 teaspoonful) 1 to 2 times daily or as recommended by the physician.
+
+Tablet-
+
+- Adults & Children over 30 kg: 1 to 2 tablets 2 to 3 times daily or as recommended by the physician.
+
",,"Concomitant intake of tetracyclines and zinc may decrease the Gl absorption and serum levels of tetracyclines. Similarly concomitant administration of zinc and fluroquinolones may decrease the Gl absorption and serum levels of some fluroquinolones. Coadministration of Niacin and HMG-CoA reductase inhibitors (eg. lovastatin) may result mayopathy and rhabdomyolysis. Pyridoxine reduces levodopa's effectiveness by increasing its peripheral metabolism. Co-administration of pyridoxine with phenytoin may decrease serum levels of phenytoin.
","Vitamin B Complex & Zinc is contraindicated in patients with a known hypersensitivity to any of the ingredients of this product.
","This is generally well tolerated. However, a few side effects like nausea, vomiting, diarrhoea & stomach upset may occur. Side effects have been reported with specific vitamins but generally at levels substantially higher than recommended doses.
","This is recommended in pregnancy and lactation.
","In acute renal failure, zinc accumulation may occur, so dosage adjustment is needed. This is not intended for the treatment of severe specific deficiencies.
",,"In case of overdosage, initially epigastric pain, diarrhoea and vomiting can occur. In that case, one should seek emergency medical attention. Initially, an emetic should be given and then gastric lavage and general supportive measures should be employed.
",,,"Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.
",11
+1366,Vitamin B complex + Vitamin C,vitamin-b-complex-vitamin-c-1366,,Specific combined vitamin preparations,Vitamin B deficiencies,"Vitamin B complex & Vitamin C is indicated in the treatment of patients with deficiencies of, or increased requirement for, vitamin B-complex and vitamin C. Such patients and conditions include:
+
+- Decreased intake because of restricted or unbalanced diet as in anorexia, diabetes mellitus, obesity and alcoholism.
... Read more
Vitamin B complex & Vitamin C is indicated in the treatment of patients with deficiencies of, or increased requirement for, vitamin B-complex and vitamin C. Such patients and conditions include:
+
+- Decreased intake because of restricted or unbalanced diet as in anorexia, diabetes mellitus, obesity and alcoholism.
+- Reduced availability during treatment with antimicrobials which alter normal intestinal flora, in prolonged diarrhea and in chronic gastrointestinal disorders.
+- Increased requirements due to increased metabolic rate as in fever and tissue wasting, e.g. febrile illness, acute or chronic infections, surgery, burns and fractures.
+- Stomatitis, glossitis, cheilosis, paraesthesias, neuralgia and dermatitis.
+- Micronutrient deficiencies during pregnancy or lactation.
+
","Specific combined vitamin preparations
","Vitamin B-Complex and Vitamin C function as cofactors of various enzymes which regulate carbohydrate, protein and fat metabolism. Thiamine (B.,) acts as a cofactor in the decarboxylation of keto acids such as pyruvic acid.
Riboflavin (B2) plays a vital role in cellular respiratory reactions in conjunction with nicotinamide.
Pyridoxine (B6) takes part in decarboxylation and interconversion of amino acids. It is also required for normal antibody-mediated and cell-mediated immune responses.
Vitamin B12 (cyanocobalamin) is required for synthesis of DNA (deoxyribo-nucleic acid) and maturation of RBCs (red blood cells). Nicotinamide (niacinamide) plays a vital role in cellular respiration in conjunction with riboflavin.
Calcium Pantothenate functions as a cofactor for enzymes involved in transfer of acetyl groups. It is also required for normal antibody response in conjunction with pyridoxine.
Folic acid, after conversion in the body to folinic acid, takes part in reactions involved in the synthesis of nucleotides and maturation of RBCs in conjunction with vitamin B12. It also plays an important role in lymphocyte-mediated immune response.
Ascorbic acid (Vitamin C) takes part in biochemical reactions involving oxidation, as in collagen synthesis, and in conversion of folic acid to folinic acid. It is also necessary for normal phagocytic function ofWBCs (white blood cells).
Thus an adequate supply of these water-soluble vitamins is required for the optimum function of various cells and tissues.Except for Vitamin B12, these water-soluble vitamins are not stored in the body to any significant extent, the excess quantities being excreted in the urine. Therefore, a regular and adequate intake of them is necessary to meet the metabolic requirements. Deficiencies of water-soluble vitamins often co-exist because of their overlapping dietary sources and metabolic interdependence. Initially the deficiency of these vitamins may be subclinical and demonstrable only by means of biochemical tests. If not corrected at this stage, it may become manifest as various symptoms, including impaired wound healing and increased susceptibility to infection. Classical deficiency diseases such as beri beri, pellagra and scurvy are rare, whereas mild and subclinical deficiencies are probably more common, even among apparently healthy individuals.
","One capsule daily or as advised by the physician.
",,,"Hypersensitivity to any of the ingredients of this preparation
","Hypersensitivity reactions have been reported with thiamine and folic acid, although these are rare.
","No data found
","The use of this capsule in patients with deficiency or increased requirement of Vitamin B-complex and Vitamin C should be accompanied by specific therapy for the primary illness.
Treatment with this capsule should be continued only until the deficiency is corrected or the need for supplementation exists. Pyridoxine in this capsule may reduce the therapeutic effects of levodopa in Parkinson’s disease.
Riboflavin in this capsule may color the urine yellow. During treatment with this capsule the urine may give a false positive result for sugar by Benedict's test because of the presence of ascorbic acid. Therefore, a test not affected by ascorbic acid should be used.
",,,,,"Store in a cool and dry place, away from light and children.
",9
+1131,Vitamin B complex,vitamin-b-complex-1131,,Specific combined vitamin preparations,Vitamin B deficiencies,"Vitamin-B complex is indicated for prophylactic or therapeutic nutritional supplementation in physiologically stressful conditions. These include: Conditions causing depletion, or reduced absorption or bioavailability of essential B-vitamins manifested by glossitis, stomatitis, cheilosis, beriberi Vitamin-B ... Read more
Vitamin-B complex is indicated for prophylactic or therapeutic nutritional supplementation in physiologically stressful conditions. These include: Conditions causing depletion, or reduced absorption or bioavailability of essential B-vitamins manifested by glossitis, stomatitis, cheilosis, beriberi Vitamin-B complex is indicated for prophylactic or therapeutic nutritional supplementation in physiologically stressful conditions. These include: Conditions causing depletion, or reduced absorption or bioavailability of essential B-vitamins manifested by glossitis, stomatitis, cheilosis, beriberi
","Specific combined vitamin preparations
","Vitamin-B complex contains the most important members of the vitamin B group in pure form and in therapeutically balanced proportions. The members of the vitamin B group contained in Vitamin-B complex are components of enzyme systems that regulate various stages of carbohydrate, fat and protein metabolism, each of the components playing a specific biological role. Deficiency of B vitamin causes glossitis, stomatitis, cheilosis, polyneuritis, beriberi, pellagra and vascularisation of cornea.
","Tablet/ capsule: usual recommended dose is 1-2 tablet/capsule 3 times daily or as directed by the physician.
Syrup: 2-3 teaspoonful daily or as directed by the physician.
Injection: It is for intramuscular and intravenous administration. Usual recommended dose is 2 ml daily or as directed by the physician. In addition with Thiamine, Riboflavin, Nicotinamide, Pyridoxine; injectable dosage from contains D-Panthenol 5 mg.
",,"As little as 5 mg pyridoxine daily can decrease the efficacy of levodopa in the treatment of parkinsonism. Therefore, Vitamin-B complex is not recommended for patients undergoing such therapy
","Vitamin-B complex is contraindicated in patients hypersensitive to any of its components.
","Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in Vitamin-B complex. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended level has been associated with gastrointestinal intolerance in some patients.
","It is safe to use Vitamin-B complex in pregnancy and lactation.
",,,,,,,8
+1150,Zuclopenthixol,zuclopenthixol-1150,https://medex.com.bd/attachments/id0vqkI7IEOp364VQWwExeAjKAKcBr/zuclopenthixol-prescribing-information,Phenothiazine related drugs,Schizophrenia,"Zuclopenthixol is indicated for the management of the manifestations of schizophrenia. This is intended for the initial treatment of acute psychotic episodes or exacerbation of psychosis associated with schizophrenia.
","Phenothiazine related drugs
","Zuclopenthixol, a thioxanthene derivative, has high affinity for both dopamine D1 receptors and dopamine D2 receptors. Zuclopenthixol also has high affinity for α1 -adrenergic and 5 HT2 receptors. It has weaker histamine H1 receptor blocking activity, and even lower affinity for muscarinic cholinergic and α2 -adrenergic receptors.
","Zuclopenthixol Tablets: When initiating treatment with Zuclopenthixol tablets, it is recommended that the drug be given in divided doses (BID or TID). During the maintenance phase of treatment Zuclopenthixol tablets may be given as a single nighttime dose. For acute psychosis, the usual starting dose is 10-50 mg/day, which may be increased by 10-20 mg every 2-3 days, according to the patient’s response. The usual therapeutic range is 20 mg to 60 mg daily. However, as with other antipsychotic drugs, some patients may require lower, while others may require higher dosage in order to obtain optimal benefit. Daily dosage higher than 100 mg is not recommended. For maintenance therapy, dosage should be reduced to the lowest level compatible with symptom control. The usual maintenance dose is 20-40 mg/day.
Zuclopenthixol Acuphase: Dosage should be individually adjusted according to the patient’s condition. The usual dose is 50-150 mg (1-3 ml) administered intramuscularly and repeated if necessary, at intervals of 2-3 days. Some patients may need an additional injection 1 or 2 days after the first injection.
Zuclopenthixol Depot: Close supervision is required during the period following initiation of Zuclopenthixol Depot treatment, in order to minimize the risk of over-medication or insufficient suppression of psychotic symptoms. Supplemental oral antipsychotic medication may be required in diminishing dosage during this period. The usual maintenance dose is 150-300 mg intramuscularly, every 2-4 weeks. Some patients may require higher or lower doses, or shorter intervals between doses.
",,"Drugs that may interact with Zuclopenthixol include:
+
+- tricyclic antidepressant medicines
+- guanethidine and similar medicines (used to lower the blood pressure)
+- barbiturates and similar medicines
+- levodopa and similar medicines (used to treat Parkinson’s disease)
+- metoclopramide (used in the treatment of gastro-intestinal disorders)
+- other antipsychotic medicines (e.g. thioridazine)
+- medicines that change the heartbeat (e.g. quinidine, amiodarone, sotalol, erythromycine, moxifloxacin, lithium)
+
","
+- Acute alcohol, barbiturate or opiate intoxication.
+- CNS depression due to any cause, comatose states, suspected or established subcortical brain damage or circulatory collapse.
+- Patients with known hypersensitivity to thioxanthenes, zuclopenthixol or to any ingredient in the formulation or component of the container.
+
","Common side effects are Racing heart (tachycardia), a sensation of a rapid, forceful, or irregular beating of the heart (palpitations) Tremor, twisting or repetitive movements or abnormal postures due to sustained muscle contractions (dystonia), increased muscle stiffness (hypertonia).
","The safe use of zuclopenthixol during pregnancy has not been established. Zuclopenthixol is excreted in human milk. The safe use of zuclopenthixol during lactation has not been established.
","Caution should be taken if-
+
+- you have used zuclopenthixol or any other treatment for schizophrenia before and if you had any problems
+- you are taking any other prescription or non-prescription medicines
+- you are pregnant or thinking of becoming pregnant, or if you are breast-feeding
+- you regularly drink a lot of alcohol
+- you have any liver problems, Parkinson’s disease or have ever had seizures
+- you have dementia
+- you have glaucoma
+- you have any kidney problems
+- you have risk factors for stroke (e.g. smoking, high blood pressure).
+- you have hypokalemia or hypomagnesia (too little potassium or magnesium in your blood)
+- you have a history of cardiovascular disorders
+- you or someone in your family has a history of blood clots
+- you are being treated for cancer (applies to zuclopenthixol Depot only)
+- you use any other antipsychotic medicine
+
","The safety and efficacy of zuclopenthixol in children under the age of 18 years have not been established, therefore its use is not recommended.
","Symptoms of overdose may include: somnolence, coma, unusual movements, convulsions, shock, high or low body temperature
",,,"Should be stored between 15°C and 25°C. Protect from light.
",12
+1149,Zopiclone,zopiclone-1149,https://medex.com.bd/attachments/W8EgbwW022NSugbnSgEGMYx9fkrTFt/zopiclone-prescribing-information,Miscellaneous sedatives & hypnotics,Insomnia and sleep disturbances,"Zopiclone is indicated for the short-term treatment and symptomatic relief of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings and/or early morning awakenings.
","Miscellaneous sedatives & hypnotics
","Zopiclone, a cyclopyrrolone derivative, is a short-acting hypnotic agent. This is structurally unrelated to existing hypnotics. However, the pharmacological profile of Zopiclone is similar to that of the benzodiazepines. Zopiclone pharmacological properties are: hypnotic, sedative, anxiolytic, anti-convulsant, muscle-relaxant. These effects are related to a specific agonist action at central receptors belonging to the GABAA macromolecular complex, modulating the opening of the chloride ion channel.
","The recommended initial dose is 3.75 mg (one-half of a 7.5 mg tablet). The dose can be increased to 5 mg and further to 7.5 mg if clinically indicated. In some patients, the higher doses result in zopiclone blood levels in the morning high enough to produce impairment of driving and other activities that require full alertness. The 7.5 mg dose should not be exceeded.
","Treatment with Zopiclone should usually not exceed 7-10 consecutive days. Use for more than 2-3 consecutive weeks requires complete re-evaluation of the patient. Prescriptions for Zopiclone should be written for short-term use (7-10 days) and it should not be prescribed in quantities exceeding a 1-month supply. The use of hypnotics should be restricted for insomnia where disturbed sleep results in impaired daytime functioning.
","Zopiclone may produce more pronounced side effects when co- administered with:
+
+- Alcohol
+- Other tranquilizers or sleeping pills
+- Sedative antihistamines
+- Anticonvulsants (medicines used to control or prevent convulsions)
+- Narcotic analgesics (opioids)
+- Antipsychotics, antidepressants and other psychotropic medications (mood altering drugs) which themselves can make you sleepy.
+
","Zopiclone is contraindicated in patients with severe hepatic insufficiency, contraindicated in patients with severe impairment of respiratory function.
","Common side effects are somnolence, dizziness, confusion, anterograde amnesia or memory impairment, feeling of drunkenness, euphoria, nightmares, agitation, anxiety or nervousness, hostility, depression, decreased libido, libido disorder, coordination abnormality, headache, hypotonia, tremor, muscle spasms, paresthesia, and speech disorder, palpitations, dysgeusia (bitter taste), dry mouth, coated tongue, bad breath, nausea, vomiting, diarrhea, constipation, anorexia or increased appetite.
","Do no take Zopiclone at anytime during pregnancy, it may affect the developing baby. Zopiclone passes into breast milk. Therefore, if you are breast feeding, this medicine should be avoided. Your doctor will discuss this with you
","
+- Do not take more Zopiclone than prescribed.
+- Do not use for longer than recommended by your physician. Treatment should be as short as possible, because the risk of dependence increases with the duration of treatment.
+- Do not take Zopiclone if you drink alcohol.
+- Talk to your doctor if you have had episodes of sleepwalking in the past, or if there is a history of sleepwalking in your family.
+- Talk to your doctor if you have a condition that affects your sleep, such as Periodic Limb Movement Disorder (involuntary movement of limbs during sleep) or Restless Legs Syndrome (urge to move legs, usually accompanied by uncomfortable and unpleasant sensations, that begins or worsens during periods of inactivity, typically in the evening and night).
+
","Zopiclone is not indicated for patients under 18 years of age.
","Overdose is usually manifested by varying degrees of central nervous system depression ranging from drowsiness to coma according to the quantity ingested. In mild cases, symptoms include drowsiness, confusion, and lethargy; in more severe cases, symptoms may include ataxia, hypotonia, hypotension, methaemoglobinaemia, respiratory depression, and coma. Overdose should not be life threatening unless combined with other CNS depressants, including alcohol. Other risk factors, such as the presence of concomitant illness and the debilitated state of the patient, may contribute to the severity of symptoms and very rarely can result in fatal outcome. Symptomatic and supportive treatment in adequate clinical environment is recommended, attention should be paid to respiratory and cardiovascular functions. Gastric lavage or activated charcoal is only useful when performed soon after ingestion.
",,,"Store in a dry place, at room temperature (15°C to 30°C). Protect from light. Keep in a safe place out of reach of children.
",13
+1380,Zonisamide,zonisamide-1380,https://medex.com.bd/attachments/TQfwOOFus50W66YxJGeksP75JXSMPM/zonisamide-prescribing-information,Adjunct anti-epileptic drugs,Partial seizures,"Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
","Adjunct anti-epileptic drugs
","The precise mechanism(s) by which zonisamide exerts its antiseizure effect is unknown. Zonisamide demonstrated anticonvulsant activity in several experimental models. In animals, zonisamide was effective against tonic extension seizures induced by maximal electroshock but ineffective against clonic seizures induced by subcutaneous pentylenetetrazol. Zonisamide raised the threshold for generalized seizures in the kindled rat model and reduced the duration of cortical focal seizures induced by electrical stimulation of the visual cortex in cats. Furthermore, zonisamide suppressed both interictal spikes and the secondarily generalized seizures produced by cortical application of tungstic acid gel in rats or by cortical freezing in cats. The relevance of these models to human epilepsy is unknown.
Zonisamide may produce these effects through action at sodium and calcium channels. In vitro pharmacological studies suggest that zonisamide blocks sodium channels and reduces voltagedependent, transient inward currents (T-type Ca2+ currents), consequently stabilizing neuronal membranes and suppressing neuronal hypersynchronization. In vitro binding studies have demonstrated that zonisamide binds to the GABA/benzodiazepine receptor ionophore complex in an allosteric fashion which does not produce changes in chloride flux. Other in vitro studies have demonstrated that zonisamide (10–30 μg/mL) suppresses synaptically-driven electrical activity without affecting postsynaptic GABA or glutamate responses (cultured mouse spinal cord neurons) or neuronal or glial uptake of [3H]-GABA (rat hippocampal slices). Thus, zonisamide does not appear to potentiate the synaptic activity of GABA. In vivo microdialysis studies demonstrated that zonisamide facilitates both dopaminergic and serotonergic neurotransmission.
Zonisamide is a carbonic anhydrase inhibitor. The contribution of this pharmacological action to the therapeutic effects of zonisamide is unknown. However, as a carbonic anhydrase inhibitor, zonisamide may cause metabolic acidosis
","Zonisamide is recommended as adjunctive therapy for the treatment of partial seizures in adults. Safety and efficacy in pediatric patients below the age of 16 have not been established. Zonisamide should be administered once or twice daily, using 25 mg or 100 mg capsules. Zonisamide is given orally and can be taken with or without food. Capsules should be swallowed whole.
Adults Over Age 16: The prescriber should be aware that, because of the long half-life of zonisamide, up to two weeks may be required to achieve steady state levels upon reaching a stable dose or following dosage adjustment. Although the regimen described below is one that has been shown to be tolerated, the prescriber may wish to prolong the duration of treatment at the lower doses in order to fully assess the effects of zonisamide at steady state, noting that many of the side effects of zonisamide are more frequent at doses of 300 mg per day and above. Although there is some evidence of greater response at doses above 100-200 mg/day, the increase appears small and formal dose-response studies have not been conducted.
The initial dose of Zonisamide should be 100 mg daily. After two weeks, the dose may be increased to 200 mg/day for at least two weeks. It can be increased to 300 mg/day and 400 mg/day, with the dose stable for at least two weeks to achieve steady state at each level. Evidence from controlled trials suggests that Zonisamide doses of 100-600 mg/day are effective, but there is no suggestion of increasing response above 400 mg/day. There is little experience with doses greater than 600 mg/day.
",,,"Zonisamide is contraindicated in patients who have demonstrated hypersensitivity to sulfonamides or zonisamide.
","The most common adverse reactions with Zonisamide (an incidence at least 4% greater than placebo) in controlled clinical trials and shown in descending order of frequency were somnolence, anorexia, dizziness, ataxia, agitation/irritability, and difficulty with memory and/or concentration.
In controlled clinical trials, 12% of patients receiving Zonisamide as adjunctive therapy discontinued due to an adverse reaction compared to 6% receiving placebo. Approximately 21% of the 1,336 patients with epilepsy who received Zonisamide in clinical studies discontinued treatment because of an adverse reaction. The most common adverse reactions leading to discontinuation were somnolence, fatigue and/or ataxia (6%), anorexia (3%), difficulty concentrating (2%), difficulty with memory, mental slowing, nausea/vomiting (2%), and weight loss (1%). Many of these adverse reactions were doserelated
","Zonisamide may cause serious adverse fetal effects, based on clinical and nonclinical data. Zonisamide was teratogenic in multiple animal species.
Zonisamide treatment causes metabolic acidosis in humans. The effect of zonisamide-induced metabolic acidosis has not been studied in pregnancy; however, metabolic acidosis in pregnancy (due to other causes) may be associated with decreased fetal growth, decreased fetal oxygenation, and fetal death, and may affect the fetus's ability to tolerate labor. Pregnant patients should be monitored for metabolic acidosis and treated as in the non-pregnant state.
Newborns of mothers treated with zonisamide should be monitored for metabolic acidosis because of transfer of zonisamide to the fetus and possible occurrence of transient metabolic acidosis following birth. Transient metabolic acidosis has been reported in neonates born to mothers treated during pregnancy with a different carbonic anhydrase inhibitor.
","Somnolence is commonly reported, especially at higher doses of Zonisamide. Zonisamide is metabolized by the liver and eliminated by the kidneys; caution should therefore be exercised when administering Zonisamide to patients with hepatic and renal dysfunction
","Patients With Renal Or Hepatic Disease: Because zonisamide is metabolized in the liver and excreted by the kidneys, patients with renal or hepatic disease should be treated with caution, and might require slower titration and more frequent monitoring
Pediatric Use: The safety and effectiveness of Zonisamide in children under age 16 have not been established. Cases of oligohidrosis and hyperpyrexia have been reported. Zonisamide commonly causes metabolic acidosis in pediatric patients. Chronic untreated metabolic acidosis in pediatric patients may cause nephrolithiasis and/or nephrocalcinosis, osteoporosis and/or osteomalacia (potentially resulting in rickets), and may reduce growth rates. A reduction in growth rate may eventually decrease the maximal height achieved. The effect of zonisamide on growth and bonerelated sequelae has not been systematically investigated.
Geriatric Use: Single dose pharmacokinetic parameters are similar in elderly and young healthy volunteers. Clinical studies of zonisamide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
","Human Experience: Experience with Zonisamide daily doses over 800 mg/day is limited. During Zonisamide clinical development, three patients ingested unknown amounts of Zonisamide as suicide attempts, and all three were hospitalized with CNS symptoms. One patient became comatose and developed bradycardia, hypotension, and respiratory depression; the zonisamide plasma level was 100.1 μg/mL measured 31 hours post-ingestion. Zonisamide plasma levels fell with a half-life of 57 hours, and the patient became alert five days later.
Management: No specific antidotes for Zonisamide overdosage are available. Following a suspected recent overdose, emesis should be induced or gastriclavage performed with the usual precautions to protect the airway. General supportive care is indicated, including frequent monitoring of vital signs and close observation.
Zonisamide has a long half-life. Due to the low protein binding of zonisamide (40%), renal dialysis may be effective. The effectiveness of renal dialysis as a treatment of overdose has not been formally studied. A poison control center should be contacted for information on the management of Zonisamide overdosage.
",,,,10
+1148,Zolpidem Tartrate,zolpidem-tartrate-1148,https://medex.com.bd/attachments/WYqMKLrUIp0LIt5v1o8aTIbF24YqhU/zolpidem-tartrate-prescribing-information,Miscellaneous sedatives & hypnotics,Insomnia and sleep disturbances,"Zolpidem is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem has been shown to decrease sleep latency for up to 35 days in controlled clinical studies
The clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.
","Miscellaneous sedatives & hypnotics
","Zolpidem is an imidazopyridine derivative that acts by binding to the benzodiazepine (BZD) receptors of the GABA receptor complex resulting in neuronal hyperpolarisation, action potential inhibition, increased in chloride conductance and decreased in neuronal excitability. It has strong sedative action but only minimal anxiolytic, myorelaxant and anticonvulsant properties due to its selectivity for the BZ1-receptor over the BZ2-receptor. Zolpidem has a rapid onset but short duration of hypnotic action.
","Dosage In Adults: Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7–8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness. The total dose of Zolpidem should not exceed 10 mg once daily immediately before bedtime. Zolpidem should be taken as a single dose and should not be readministered during the same night.
The recommended initial doses for women and men are different because zolpidem clearance is lower in women.
Special Populations: Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. The recommended dose of Zolpidem in these patients is 5 mg once daily immediately before bedtime
Patients with mild to moderate hepatic impairment do not clear the drug as rapidly as normal subjects. The recommended dose of Zolpidem in these patients is 5 mg once daily immediately before bedtime. Avoid Zolpidem use in patients with severe hepatic impairment as it may contribute to encephalopathy
Use With CNS Depressants: Dosage adjustment may be necessary when Zolpidem is combined with other CNS depressant drugs because of the potentially additive effects
","The effect of Zolpidem may be slowed by ingestion with or immediately after a meal.
","Co-administration of zolpidem with other CNS depressants increases the risk of CNS depression. Concomitant use of zolpidem with these drugs may increase drowsiness and psychomotor impairment, including impaired driving ability. Zolpidem tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs.
Imipramine, Chlorpromazine: Imipramine in combination with zolpidem produced no pharmacokinetic interaction other than a 20% decrease in peak levels of imipramine, but there was an additive effect of decreased alertness. Similarly, chlorpromazine in combination with zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance
Haloperidol: A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem. The lack of a drug interaction following single-dose administration does not predict the absence of an effect following chronic administration
Alcohol: An additive adverse effect on psychomotor performance between alcohol and oral zolpidem was demonstrated
Sertraline: Concomitant administration of zolpidem and sertraline increases exposure to zolpidem
Fluoxetine: After multiple doses of zolpidem tartrate and fluoxetine an increase in the zolpidem half-life (17%) was observed. There was no evidence of an additive effect in psychomotor performance
","Severe hepatic impairment.
","Atypical thinking and behaviour, hallucination, nightmare, somnolence, somnambulism, headache, nausea, vomiting, dizziness, vertigo, drowsiness, asthenia, ataxia, rebound insomnia, amnesia, GI disturbances, upper and lower respiratory tract infection, fatigue, visual disturbances, increased ALT serum concentrations, abnormal LFT.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Obstructive sleep apnoea, myasthenia gravis, compromised respiratory function. Patients exhibiting symptoms of depression. History of drug or alcohol abuse. Avoid abrupt withdrawal and rapid dose reduction after prolonged therapy. Re-evaluate if insomnia fail to remit after 7-10 days as this may indicate the presence of underlying psychiatric and/or medical condition. Pregnancy, lactation, childn <18 yr.
","Pediatric Use: Zolpidem is not recommended for use in children. Safety and effectiveness of zolpidem in pediatric patients below the age of 18 years have not been established.
","Symptoms: Drowsiness, impairment of consciousness from somnolence to coma, compromised CV and respiratory function.
Management: Treatment is largely symptomatic and supportive. IV fluids should be administered as needed. Activated charcoal may be given if presented w/in 1 hr of ingestion of >1 mg/kg zolpidem in adults or childn. Gastric lavage may be considered if presented w/in 1 hr of ingestion of >100 mg zolpidem and monitor for at least 12 hr. Flumazenil may be used if there is severe CNS depression, but generally not needed. Haemodialysis is unlikely to be useful.
",,,"Store between 20-25° C.
",13
+1147,Zolmitriptan,zolmitriptan-1147,https://medex.com.bd/attachments/ghniLKhaEClghhcCd2IUa7eWC7zExK/zolmitriptan-tablet-prescribing-information,5-HT Agonists,Migraines,"Zolmitriptan is indicated for the acute treatment of migraines with or without aura in adults.
","5-HT Agonists
","Migraines are likely due to local cranial vasodilatation and/or to the release of sensory neuropeptides through nerve endings in the trigeminal system. The therapeutic activity of Zolmitriptan for the treatment of migraine headache is thought to be due to the agonist effects at the 5-HT1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system which results in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.
","Tablet: The recommended starting dose of Zolmitriptan is 2.5 mg tablet. Maximum recommended single dose is 5 mg. If the migraine has not resolved by 2 hours after taking Zolmitriptan, or returns after a transient improvement, a second dose may be administered at least 2 hours after the first dose. The maximum daily dose is 10 mg in any 24-hours period.
Nasal Spray: Administer one dose of Zolmitriptan Nasal Spray 5 mg for the treatment of acute migraine. If the headache returns the dose may be repeated after 2 hours. The maximum daily dose should not exceed 10 mg in any 24-hour period. In controlled clinical trials, single doses of 5 mg zolmitriptan nasal spray were administered into one nostril and were effective for the treatment of acute migraines in adults. Individuals may vary in response to Zolmitriptan Nasal Spray. The pharmacokinetics of a 5 mg nasal spray dose is similar to the 5 mg oral formulations. Doses lower than 5 mg can only be achieved through the use of an oral formulation. The choice of dose, and route of administration should therefore be made on an individual basis. The effectiveness of a second dose has not been established in placebo-controlled trials. The safety of treating an average of more than four headaches in a 30 day period has not been established.
",,,"Contraindicated in patients with ischemic coronary artery disease, history of stroke, concurrent or recent use of a monoamine oxidase inhibitor and known hypersensitivity to Zolmitriptan.
","Most common adverse reactions were neck/throat/jaw pain or pressure, dizziness, paresthesia, asthenia, somnolence, warm/cold sensation, nausea, heaviness sensation, and dry mouth.
","Pregnancy Category C. Zolmitriptan should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Zolmitriptan is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
","There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration. Sensations of tightness, pain, and pressure may occur in the chest, throat, neck, and jaw after treatment with Zolmitriptan.
","Pediatric Use: Not recommended for use in patients under 18 years of age.
",,,,"Protect from light and moisture, store below 30°C. Keep the medicine out of the reach of children.
",10
+1368,Zoledronic Acid [For osteoporosis],zoledronic-acid-for-osteoporosis-1368,https://medex.com.bd/attachments/6Hgw6qTcwglmZl03v3KgeX3NJdop6L/zoledronic-acid-for-osteoporosis-prescribing-information,Bisphosphonate preparations,Post-menopausal osteoporosis,"Zoledronic Acid is indicated for the treatment of osteoporosis in postmenopausal women to reduce the incidence of hip, vertebral and non-vertebral fractures; prevention of clinical fractures after a hip fracture; treatment and prevention of glucocorticoid-induced osteoporosis; treatment of osteoporosis ... Read more
Zoledronic Acid is indicated for the treatment of osteoporosis in postmenopausal women to reduce the incidence of hip, vertebral and non-vertebral fractures; prevention of clinical fractures after a hip fracture; treatment and prevention of glucocorticoid-induced osteoporosis; treatment of osteoporosis in men and for the treatment of paget's disease of bone. Treatment should be restricted to three annual doses.
","Bisphosphonate preparations
","Zoledronic acid belongs to the class of nitrogen-containing bisphosphonates and acts primarily on bone. It is an inhibitor of osteoclast-mediated bone resorption. The action of bisphosphonates on bone is based on their high affinity for mineralized bone. Intravenously administered Zoledronic acid is rapidly distributed to bone. The main molecular target of Zoledronic acid in the osteoclast is the enzyme farnesyl pyrophosphate synthase, but this does not exclude other mechanisms. There was no accumulation of the active substance in plasma after multiple doses given every 28 days. Zoledronic acid is not metabolized and is excreted unchanged via the kidney.
","Treatment of postmenopausal osteoporosis: Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid administered once a year. Adequate supplemental Calcium and Vitamin-D intake is important in women with osteoporosis if dietary intake is inadequate.
Prevention of clinical fractures after a hip fracture: Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid administered once a year. In patients with a recent low-trauma hip fracture, it is recommended to give the first Zoledronic Acid solution for infusion two or more weeks after hip fracture repairs. It is also recommended to have a loading dose of 50,000 to 125,000 IU of Vitamin-D given orally or via intramuscular route prior to the first administration of Zoledronic Acid solution for infusion. Supplemental Calcium and Vitamin-D intake is recommended for patients treated to prevent clinical fractures after a hip fracture.
Treatment of osteoporosis in men: Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid administered once a year. Adequate supplemental Calcium and Vitamin-D intake is important in men with osteoporosis if dietary intake is inadequate.
Treatment and prevention of glucocorticoid-induced osteoporosis: Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid administered once a year. Adequate supplemental Calcium and Vitamin-D intake is important in patients with osteoporosis if dietary intake is inadequate.
Treatment of paget's disease of bone: Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid. Re-treatment with Zoledronic Acid may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase, in patients who failed to achieve normalization of serum alkaline phosphatase, or in patients with symptoms, as dictated by medical practice 12 months after the initial dose.
In patients with paget's disease, adequate Vitamin-D intake is recommended in association with Zoledronic Acid administration. In addition, it is strongly advised that adequate supplemental Calcium corresponding to at least 500 mg elemental Calcium twice daily is ensured in patients with paget's disease for at least 10 days following Zoledronic Acid administration.
","The dose of 5 mg Zoledronic acid must be administered over at least 15 minutes. Zoledronic Acid should be administered intravenously via a infusion line, given at a constant infusion rate. The infusion time must not be less than 15 minutes.
","Specific drug-drug interaction studies have not been conducted with Zoledronic acid. Zoledronic acid is eliminated by renal excretion. Caution is indicated when Zoledronic Acid is administered in conjunction with drugs that can significantly impact renal function (e.g. aminoglycosides or diuretics that may cause dehydration).
","The drug is contraindicated if patients have hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates, hypocalcaemia, renal impairment (creatinine clearance <35 mL/min), current or recent uveitis, or a history of bisphosphonate-associated uveitis, pregnancy and lactation.
","The post-dose side-effects are fever, myalgia, flu-like symptoms, arthralgia and headache, the majority of which occur within the first 3 days following Zoledronic Acid administration. The majority of these symptoms were mild to moderate in nature and resolved within 3 days of the event onset. The incidence of these symptoms occurring within the first 3 days after administration of Zoledronic Acid, can be reduced with the administration of Paracetamol or Ibuprofen shortly following Zoledronic Acid administration. Severe and occasionally incapacitating bone, joint, and/or muscle pain have been infrequently reported in patients taking Zoledronic Acid.
","Zoledronic Acid is contraindicated during pregnancy and in breast-feeding women. It is also not recommended for use in children and adolescents below 18 years of age.
","Patients must be appropriately hydrated prior to administration of Zoledronic Acid. This is especially important in the elderly and for patients receiving diuretic therapy. Adequate hydration can be achieved by the patient drinking two glasses of fluid (such as water) before and after the infusion. Pre-existing hypocalcaemia must be treated by adequate intake of Calcium and Vitamin-D before initiating therapy with Zoledronic Acid. Other disturbances of mineral metabolism must also be effectively treated (e.g. diminished parathyroid reserve, thyroid surgery, parathyroid surgery, intestinal Calcium malabsorption). Physicians should consider clinical monitoring for these patients.
","Patients with renal impairment: The use of Zoledronic Acid in patients with creatinine clearance <35 mL/min is not recommended due to limited clinical safety data in such patients. No dose adjustment is necessary in patients with creatinine clearance >35 mL/min.
Patients with hepatic impairment: No dose adjustment is required for patients with hepatic impairment.
Elderly patients: No dose adjustment is required. However, because decreased renal function occurs more commonly in the elderly, special care should be taken to monitor renal function.
Zoledronic Acid must not be mixed or given intravenously with any other medication and must be given through a separate infusion line at a constant infusion rate. If refrigerated, allow the refrigerated solution to reach room temperature before administration. Aseptic techniques must be followed during the preparation of the infusion. Any unused solution should be discarded. Only clear solution free from particles and discoloration should be used.
After opening, the solution is chemically and physically stable for at least 24 hours at 2°C to 8°C. From a microbiological point of view, the product should be used immediately. Zoledronic Acid solution for infusion must not be allowed to come into contact with any Calcium or other divalent cation-containing solutions.
","Clinical experience with acute over dosage is limited. Patients who have received doses higher than those recommended should be carefully monitored. In the event of overdose leading to clinically significant hypocalcaemia, reversal may be achieved with supplemental oral Calcium and/or an infusion of Calcium.
",,,"Store below 30° C prior to opening. Protect from moisture and light. Zoledronic Acid must be kept out of the reach and sight of children.
",13
+1146,Zoledronic Acid [For hypercalcemia],zoledronic-acid-for-hypercalcemia-1146,https://medex.com.bd/attachments/SizEcCxlrXxkWyPEYhicca4Rh15Kjp/zoledronic-acid-for-hypercalcemia-prescribing-information,Bisphosphonate preparations,Post-menopausal osteoporosis,"Zoledronic Acid is indicated in:
+
+- Hypercalcaemia of malignancy,
+- Bone metastases associated with solid tumours, Osteolytic lesions associated with multiple myeloma,
+- Corticosteroid-induced osteoporosis, Increase bone mass in men with osteoporosis, Osteoporosis in postmenopausal women
+- Paget's disease of bone
+- Prophylaxis of postmenopausal osteoporosis
+
","Bisphosphonate preparations
","Zoledronic acid belongs to the class of nitrogen-containing bisphosphonates and acts primarily on bone. It is an inhibitor of osteoclast-mediated bone resorption. The action of bisphosphonates on bone is based on their high affinity for mineralized bone. Intravenously administered Zoledronic acid is rapidly distributed to bone. The main molecular target of Zoledronic acid in the osteoclast is the enzyme farnesyl pyrophosphate synthase, but this does not exclude other mechanisms. Clinical studies in tumour-induced hypercalcemia demonstrated that the effect of Zoledronic acid is characterized by decreases in serum calcium and urinary calcium excretion. In addition to its inhibitory activity against bone resorption, Zoledronic acid also possesses anti-tumour activity, anti-angiogenic activity, anti-pain activity, cytostatic and pro-apoptotic activity on tumour cells and synergistic cytostatic effect with other anti-cancer drugs. There was no accumulation of the active substance in plasma after multiple doses given every 28 days. Zoledronic acid is not metabolized and is excreted unchanged via the kidney.
","Hypercalcemia of malignancy: The maximum recommended dose of Zoledronic Acid in hypercalcemia of malignancy (serum calcium 12 mg/dl or 3.0 mmol/l) is 4 mg. The 4 mg dose must be given as a single-dose intravenous infusion. Dose adjustment of Zoledronic Acid is not necessary in treating patients for hypercalcemia of malignancy presenting with mild-to-moderate renal impairment. Re-treatment with Zoledronic Acid may be considered if serum calcium does not return to normal after initial treatment. It is recommended that a minimum of 7 days elapse before re-treatment, to allow for full response to the initial dose.
Multiple myeloma and bone metastases of solid tumors: The recommended dose of Zoledronic Acid in patients with multiple myeloma and metastatic bone lesions from solid tumors is 4 mg infused every 3-4 weeks. Patients should also be administered an oral calcium supplement of 500 mg and 400 IU of Vitamin-D daily.
","Prior to administration, the required amount of concentrate from one vial must be further diluted with 100 ml of calcium-free infusion solution (0.9% w/v sodium chloride solution or 5% w/v glucose solution). The duration of infusion must not be less than 15 minutes. After addition of the solution to the infusion media, the infusion solution should be used as soon as possible. If storage of the infusion solution is necessary, hold at 2-8º C for not more than 24 hours. If refrigerated, the solution must be allowed to reach room temperature before administration.
Zoledronic Acid must not be mixed with calcium or other divalent cation-containing infusion solutions, such as Lactated Ringer's solution, and should be administered as a single intravenous solution in a line separate from all other drugs.
","In clinical studies, Zoledronic acid has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without interactions. Caution is advised when Zoledronic acid are administered with aminoglycosides, since these agents may have an additive effect to lower serum calcium level for prolonged periods. In multiple myeloma patients, the risk of renal dysfunction may be increased when Zoledronic acid is used in combination with thalidomide. Concomitant use of loop diuretics with Zoledronic acid increases the risk of hypocalcemia. Caution is indicated when Zoledronic acid is used with other potentially nephrotoxic drugs.
","The drug is contraindicated if patients have hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates; severe renal impairment (Creatinine clearance <30 ml/min); pregnancy and lactation.
","The post-dose side-effects are headache, nausea, anorexia, fatigue, osteonecrosis of jaw, anemia, bone pain, constipation, fever, vomiting, flu-like syndrome, hypocalcemia, myalgia, arthralgia and hypophosphataemia.
","Zoledronic acid is contraindicated during pregnancy and in breast-feeding women. It is also not recommended for use in children and adolescents below 18 years of age.
","Patients must be appropriately hydrated prior to administration of Zoledronic Acid. This is especially important in the elderly and for patients receiving diuretic therapy. Adequate hydration can be achieved by the patient drinking two glasses of fluid (such as water) before and after the infusion. Serum levels of calcium, phosphate, magnesium and potassium, as well as serum creatinine should be carefully monitored after initiating Zoledronic Acid therapy. If hypocalcemia, hypophosphatemia or hypomagnesemia occurs, short-term supplemental therapy may be necessary. Moreover, careful renal function monitoring should be considered.
","Patients with renal impairment: The use of Zoledronic Acid is not recommended in patients with severe renal impairment (Creatinine clearance <30 ml/min). No dose adjustment is necessary in patients with creatinine clearance >60 ml/min. Based on creatinine clearance the following dose should be used in patient with impaired renal function:
+
+- CrCl > 60 ml/min: 4 mg (5 ml)
+- CrCl 50-60 ml/min: 3.5 mg (4.4 ml)
+- CrCl 40-49 ml/min: 3.3 mg (4.1 ml)
+- CrCl 30-39 ml/min: 3 mg (3.8 ml)
+
","Clinical experience with acute over dosage is limited. Over dosage may cause hypocalcemia, hypophosphatemia, and hypomagnesemia. In such case, reduction in serum levels of calcium, phosphorus, and magnesium should be corrected by intravenous administration of calcium gluconate, potassium or sodium phosphate and magnesium sulfate respectively.
",,"Dilute the required amount in 100 mL of NaCl 0.9% or dextrose 5%.
","Store below 30° C prior to opening. Protect from moisture and light. Zoledronic Acid must be kept out of the reach and sight of children.
",14
+1145,Ziprasidone,ziprasidone-1145,https://medex.com.bd/attachments/Nu05QjsBvIaMS5SZceVDmW4R6wfvlQ/ziprasidone-prescribing-information,Atypical neuroleptic drugs,Schizophrenia,"Ziprasidone is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of Ziprasidone to prolong the QT interval and may consider the use of other drugs first. Ziprasidone capsules are indicated for the:
+
+- treatment of schizophrenia in adults.
... Read more
Ziprasidone is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of Ziprasidone to prolong the QT interval and may consider the use of other drugs first. Ziprasidone capsules are indicated for the:
+
+- treatment of schizophrenia in adults.
+- acute treatment of adults as monotherapy of manic or mixed episodes associated with bipolar I disorder.
+- maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults.
+
","Atypical neuroleptic drugs
","The mechanism of action of ziprasidone in the treatment of the listed indications could be mediated through a combination of dopamine type 2 (D2) and serotonin type 2 (5HT2) antagonism. Ziprasidone binds with relatively high affinity to the dopamine D2 and D3, serotonin 5HT2A, 5HT2C, 5HT1A, 5HT1D, and α1-adrenergic receptors (Ki s of 4.8, 7.2, 0.4, 1.3, 3.4, 2, and 10 nM, respectively), and with moderate affinity to the histamine H1 receptor (Ki=47 nM). Ziprasidone is an antagonist at the D2, 5HT2A, and 5HT1D receptors, and an agonist at the 5HT1A receptor. Ziprasidone inhibited synaptic reuptake of serotonin and norepinephrine. No appreciable affinity was exhibited for other receptor/binding sites tested, including the cholinergic muscarinic receptor (IC50 >1 µM).
","Administer capsules orally with food. Do not open, crush, or chew.
Schizophrenia: Initiate at 20 mg twice daily. Daily dosage may be adjusted up to 80 mg twice daily. Dose adjustments should occur at intervals of not less than 2 days. Safety and efficacy has been demonstrated in doses up to 100 mg twice daily. The lowest effective dose should be used.
Acute treatment of manic/mixed episodes of bipolar I disorders: Initiate at 40 mg twice daily. Increase to 60 mg or 80 mg twice daily on day 2 of treatment. Subsequent dose adjustments should be based on tolerability and efficacy within the range of 40–80 mg twice daily.
Maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate: Continue treatment at the same dose on which the patient was initially stabilized, within the range of 40–80 mg twice daily.
Acute treatment of agitation associated with schizophrenia (intramuscular administration): 10 mg 20 mg up to a maximum dose of 40 mg per day. Doses of 10 mg may be administered every 2 hours. Doses of 20 mg may be administered every 4 hours.
",,"Ziprasidone should not be used in combination with other drugs that have demonstrated QT prolongation. The absorption of ziprasidone is increased up to two-fold in the presence of food.
","
+- Do not use in patients with a known history of QT prolongation
+- Do not use in patients with recent acute myocardial infarction
+- Do not use in patients with uncompensated heart failure
+- Do not use in combination with other drugs that have demonstrated QT prolongation
+- Do not use in patients with known hypersensitivity to ziprasidone
+
","Commonly observed adverse reactions (incidence ≥5% and at least twice the incidence for placebo) were:
+
+- Schizophrenia: Somnolence, respiratory tract infection.
+- Manic and Mixed Episodes Associated with Bipolar Disorder: Somnolence, extrapyramidal symptoms, dizziness, akathisia, abnormal vision, asthenia, vomiting.
+- Intramuscular administration (≥5% and at least twice the lowest intramuscular ziprasidone group): Headache, nausea, somnolence.
+
",,"Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack).
QT Interval Prolongation: ziprasidone use should be avoided in patients with bradycardia, hypokalemia or hypomagnesemia, congenital prolongation of the QT interval, or in combination with other drugs that have demonstrated QT prolongation.
Neuroleptic Malignant Syndrome (NMS): Potentially fatal symptom complex has been reported with antipsychotic drugs. Manage with immediate discontinuation of drug and close monitoring.
Severe Cutaneous Adverse Reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and Stevens-Johnson syndrome has been reported with ziprasidone exposure. DRESS and other Severe Cutaneous Adverse Reactions (SCAR) are sometimes fatal. Discontinue ziprasidone if DRESS or SCAR are suspected.
Tardive Dyskinesia: May develop acutely or chronically.
Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/ cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain.
Hyperglycemia and Diabetes Mellitus (DM): Monitor all patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients with DM risk factors should undergo blood glucose testing before and during treatment.
Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics.
Weight Gain: Weight gain has been reported. Monitor weight gain.
Rash: Discontinue in patients who develop a rash without an identified cause.
Orthostatic Hypotension: Use with caution in patients with known cardiovascular or cerebrovascular disease.
Leukopenia, Neutropenia, and Agranulocytosis has been reported with antipsychotics. Patients with a pre existing low white blood cell count (WBC) or a history of leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and should discontinue ziprasidone at the first sign of a decline in WBC in the absence of other causative factors.
Seizures: Use cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
Potential for Cognitive and Motor impairment: Patients should use caution when operating machinery.
Suicide: Closely supervise high-risk patients.
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",9
+1144,Zinc Sulfate Monohydrate,zinc-sulfate-monohydrate-1144,,Specific mineral preparations,Zinc deficiency,"Zinc Sulfate Monohydrate is indicated in zinc deficiency and/or zinc losing conditions. Zinc deficiency can occur as a result of inadequate diet or malabsorption. Excessive loss of zinc can occur in trauma, burns, diarrhoea and protein losing conditions. A zinc supplement is given until clinical improvement ... Read more
Zinc Sulfate Monohydrate is indicated in zinc deficiency and/or zinc losing conditions. Zinc deficiency can occur as a result of inadequate diet or malabsorption. Excessive loss of zinc can occur in trauma, burns, diarrhoea and protein losing conditions. A zinc supplement is given until clinical improvement occurs but it may need to be continued in severe malabsorption, metabolic disease or in zinc losing states.
","Specific mineral preparations
","Zinc sulphate monohydrate is an essential trace element and is involved in a number of body enzyme systems. The body needs zinc for normal growth and health. Zinc is also vital for sexual maturation and reproduction, dark vision adaptation, olfactory and gustatory activity, insulin storage & release and for a variety of host immune defenses. Zinc deficiency may lead to impaired immune function, delayed wound healing, a decrease in sense of taste and smell, a reduced ability to fight infections, poor night vision, increased risk of abortion, alopecia, mental lethargy, skin changes and poor development of reproductive organs.
","Child under 10 kg: 5 ml (1 teaspoonful) 2 times daily after food.
Child between 10-30 kg: 10 ml (2 teaspoonfuls) 1-3 times daily after food.
Adults and child over 30 kg: 20 ml (4 teaspoonfuls) 1-3 times daily after food.
This drug is most effective if they are taken at least 1 hour before or 2 hour after meals. However, if causes stomach upset, this may be taken with a meal.
","For dispersible tablet
-
+
+- Place the tablet in a teaspoon
+- Add adequate amount of water
+- Let the tablet dissolve completely
+- Give the entire spoonful solution
+
","Concomitant intake of a tetracycline and zinc may decrease the absorption of both the tetracycline and zinc. Similarly concomitant administration of zinc and quinolone drug may also decrease the absorption of both. Concomitant intake of penicillamine and zinc may decrese absorption of zinc.
","It is contraindicated in those who are hypersensitive to any component of the ingredient of this preparation.
","Zinc may cause nausea, vomiting, diarrhoea, stomach upset, heartburn and gastritis.
","The safety of this product in human pregnancy has not been established. Zinc crosses the placenta and is present in breast milk.
","In acute renal failure, zinc accumulation may occur in body; so dose adjustment is needed.
",,,,,"Keep in a dry place away from light and heat. Keep out of the reach of children.
",11
+1670,"Zinc oxide, Octinoxate, Enzacamene and Avobenzone",zinc-oxide-octinoxate-enzacamene-and-avobenzone-1670,,Sunblock Preparation,Sunburn,"This cream is indicated for protection from harmful UV rays and thus managing photodermatoses, skin pigmentation, solar urticaria, acute solar dermatitis, drug-induced photosensitivity, acute lupus erythematosus, polymorphic light eruption, etc.
","Sunblock Preparation
","This cream is a combination of 4 ingredients which provide a highly protective sunscreen action.Thus, it protects against the harmful effects of ultraviolet rays of sun which can cause skin cancer, wrinkle, premature aging and darkening of skin. Its Sun Protection Factor (SPF) is 60 & Protection Grade of UVA (PA) is +++, making it perfect for both UVA & UVB protection. Zinc Oxide acts as screen and reflects & scatters UV radiation in order to protect the skin.Avobenzone,Octinoxate and Enzacamene absorb UV radiation and convert it to heat, which is then released from the skin. Strong stay-on properties making it long lasting sunscreen.
","Apply on the exposed area of the body to sunlight (such as face, neck & body) at least 30 minutes before exposure and whenever necessary. Massage on to skin until absorbed. To ensure maximum protection, repeat the application every two hours after continuous exposure to the sun and after swimming, physical exercise.
","
+- Take an adequate amount of cream
+- Apply as a thin layer on the face or, other exposed body area
+- Gently massage onto the skin
+
","It is not known whether this preparation has any interaction with other topically applied drug products.
","This preparation is contraindicated in patients with a history of sensitivity to any components of the preparation.
","Signs of irritations (erythema, burning or rash) may appear when applied to sensitive or broken skin.
","Pregnancy Category C. It is not known whether this preparation is excreted in human milk. Caution should be exercised when this cream is administered to a nursing woman.
","For external use only. Transient stinging or burning may occur when applied to abraded or broken skin.
","Pediatric Use: The safety and effectiveness of this cream have not been established in pediatric patients.
",,,,"Store below 30°C. Do not freeze. Keep out of reach of children.
",12
+1567,Zinc Oxide + Virgin Castor Oil,zinc-oxide-virgin-castor-oil-1567,https://medex.com.bd/attachments/daKmrI2SJuqOnwBqS9UiJYttO7aHud/zinc-oxide-virgin-castor-oil-prescribing-information,Emollients & combined preparations,Skin rash,"For relief of the symptoms of nappy rash and as a protective water resistant cream for dry, chapped skin.
","Emollients & combined preparations
","Zinc oxide has a mild antiseptic action, and is useful for relieving the symptoms of nappy rash and other minor skin irritations. The formulation as a whole acts to provide a mildly antiseptic water resistant emollient barrier for dry skin conditions and nappy rash.
","Applied directly to the skin. As required, up to four times daily or at each nappy change. The product is suitable for use by adults, children and the elderly.
",,"May mask x-ray pictures under certain circumstances.
","Known hypersensitivity to any of the ingredients listed.
",,"No information is available on the safety of the product when used during pregnancy and lactation.
","For external use only. Keep all medicines out of sight and reach of children. Instruct patients not to smoke or go near naked flames– risk of severe burns. Fabric (clothing, bedding, dressings, etc.) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
Zinc and Castor Oil Ointment BP contains Arachis Oil (peanut oil) and should not be applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with soya allergy should also avoid Zinc and Castor Oil Ointment. or
Zinc and Castor Oil Cream contains Arachis Oil (peanut oil) and should not be applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with soya allergy should also avoid Zinc and Castor Oil Cream.
",,"Overdosage is unlikely. If accidentally ingested treatment should be symptomatic. Oral ingestion of large quantities of castor oil may cause nausea, vomiting, colic and diarrhoea.
",,,"Store below 25°C.
",10
+1193,Zinc oxide + Ethylhexyl Methoxycinnamate + 4-Methylbenzylidene Camphor + Butyl Methoxydibenzoylmethane,zinc-oxide-ethylhexyl-methoxycinnamate-4-methylbenzylidene-camphor-butyl-methoxydibenzoylmethane-1193,,Sunblock Preparation,Sunblock,"This cream is ideal for those with photodermatoses & reduced skin pigmentation, Protection from harmful UV rays, Sunblock. Benefit of this cream is Sunblock with SPF60/ PA+++, Non-greasy & hypoallergenic, Perfume-free, Contains Vitamin E, Water resistant.
","Sunblock Preparation
","Zinc oxide has astringent, soothing and protective properties and is used in topical preparations for eczema, slight excoriations, wounds and haemorrhoids. It also reflects ultraviolet radiation and can be used as a physical sunscreen.
","Apply on the area exposed to sunlight (such as face, neck & body) at least 30 min before exposure and whenever necessary. Massage on to skin until absorbed.
To ensure maximum protection, we recommend repeating the application every two hours after continuous exposure to the sun and after swimming, physical exercise (sweat or dry with towel).
",,"There are no known drug interactions and none well documented.
","Hypersensitivity to any ingredient in zinc oxide cream, lotion
","Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
","Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","Zinc oxide cream may be harmful if swallowed. Pregnancy & Lactation.
",,,,,,9
+1605,Zinc oxide + Benzyl alcohol + Benzyl benzoate + Benzyl cinnamate + Lanolin,zinc-oxide-benzyl-alcohol-benzyl-benzoate-benzyl-cinnamate-lanolin-1605,https://medex.com.bd/attachments/hrAumWKeN0dbXheDHHckwbglxl9iDG/zinc-oxide-benzyl-alcohol-benzyl-benzoate-benzyl-cinnamate-lanolin-prescribing-information,Sunblock Preparation,Sunburn,"In the treatment of Napkin rash, Eczema, Bedsores, Acne, Minor burns, Surface wounds, Sunburn, Chilblains.
","Drugs used in diaper rash, Sunblock Preparation
","
+- Zinc oxide: A dermatological agent with astringent, soothing and protective properties.
+- Benzyl alcohol: A local anaesthetic with disinfectant properties.
+- Benzyl benzoate: An acaricide and has been used as a pediculicide, insect repellent and pharmaceutical solubilising agent. It is a constituent of many natural balsams and is one of the principal esters of Peru Balsam.
+- Benzyl cinnamate: This is the other principal ester of Peru Balsal BPC 1973. It is synthetised from benzyl alcohol and cinnamic acid which has antibacterial and antifungal properties. Peru Balsam is categorised as having a mild antiseptic action because of cinnamic acid and its derivatives present.
+- Lanolin: Resembles the sebaceous secretions of human skin. The grade (hypoallergenic) used is manufactured so as to exclude many sensitising substances present in the lanolin.
+
","Apply a thin layer with suitable covering where necessary. Renew application as required. No distinction is required between indications or between adults, children and the elderly. Topical cream for external use only.
",,,"Hypersensitivity to any of the ingredients.
","Side effects include local hypersensitivity occasionally.
","There are no known contraindications in pregnancy & lactation.
","For external use only and should not be allowed to come into contact with the eyes and the mucous membranes. Instruct patients not to smoke or go near naked flames- risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
",,"No case of overdose has been reported. If large amounts are swallowed accidentally, this may cause vomiting, diarrhoea, CNS stimulation and convulsions. Symptomatic treatment should be provided.
",,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+755,Zinc Oxide [Microfine],zinc-oxide-microfine-755,,Sunblock Preparation,Sunblock,"Regular use may help protect against premature skin aging, appearance of wrinkles and pigmentation and sunburn. Improve quality of skin and leave the skin supple and healthy.
","Sunblock Preparation
","Zinc oxide has astringent, soothing and protective properties and is used in topical preparations for eczema, slight excoriations, wounds and haemorrhoids. It also reflects ultraviolet radiation and can be used as a physical sunscreen.
","Apply on the area exposed to sunlight (such as face, neck & body) at least 30 min before exposure and whenever necessary. Massage on to skin until absorbed. To ensure maximum protection, we recommend repeating the application every two hours after continuous exposure to the sun and after swimming, physical exercise (sweat or dry with towel).
",,"There are no known drug interactions and none well documented.
","Hypersensitivity to any ingredient in zinc oxide cream, lotion
","Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
","Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
","Zinc oxide cream may be harmful if swallowed. Pregnancy & Lactation.
",,,,,"Store below 30°C.
",10
+1143,Zinc Oxide,zinc-oxide-1143,https://medex.com.bd/attachments/Th4wrmEPDgdTZMBNA2nkS9NdNpDbGI/zinc-oxide-prescribing-information,Drugs used in diaper rash,Pressure sores,"Zinc Oxide helps treat and prevent diaper rash while it moisturizes and nourishes the skin. The Zinc Oxide based formulation provides a protective barrier on the skin against the natural causes of irritation. Zinc Oxide spreads on smooth and wipes off the baby easily, without causing irritation to the affected area.
","Drugs used in diaper rash
","Zinc oxide is used to treat or prevent minor skin irritations such as burns, cuts, poison ivy, poison oak, poison sumac, and diaper rash. It is also used as sunscreen.
","Change wet and soiled diapers promptly, cleanse the diaper area, and allow drying. Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
",,"No hazardous drug interactions have been reported.
","Known hypersensitivity to any component of the preparation.
","Usually well tolerated. Extremely low frequency of hypersensitivity reaction.
","This medication should be used with precautions only if clearly needed during pregnancy or while breast feeding
","When using this product avoid contact with eyes Stop use and ask a doctor if the condition worsens or does not improve within 7 days. This may be a sign of a serious condition. Keep out of reach of children. If swallowed, get medical help immediately
",,"No overdose related problem is yet reported.
",,,"Keep at cool and dry place, away from light. Keep out of the reach of children.
",11
+1446,Zinc Orotate,zinc-orotate-1446,,Specific mineral preparations,Severe diarrhea,"Oral zinc therapy is indicated in zinc deficiency and/or zinc losing conditions like- Hair loss, Skin rashes, Major depression, Loss of smell, taste and memory, White spots on the fingernails, Increased susceptibility to infection, Loss of activity of growth hormone (GH), Visual impairment, fingernails, Diarrhea, Male infertility, Sickle cell anemia, Delayed wound healing, Type-2 diabetes.
","Specific mineral preparations
","Zinc, a major mineral, plays a part in almost all the body's cellular and enzymatic processes. Its bioavailability and digestive assimilation increases significantly when bound to orotic acid. An essential component of over 80 enzymes, it plays a role in all metabolism and has a specific antioxidant, anti-free radical action.
","Adults: One tablet twice daily with meal.
",,"Concomitant intake of tetracycline, quinolone and penicillamine along with zinc may decrease the absorption of both drugs.
",,"Zinc might cause nausea, vomiting, metallic taste and stomach upset etc.
","It should be used in pregnant or lactating mother after consultation with a health care professional.
","Patients with diabetes & acute renal failure should use zinc products cautiously.
",,"Taking doses higher than 40 mg (elemental zinc) daily might cause fever, cough, upset stomach.
",,,"Store in a cool and dry place, away from light & moisture. Keep out of the reach of children.
",10
+1229,Zidovudine,zidovudine-1229,https://medex.com.bd/attachments/0mGjgWhMzmyPKtEiSAeBrwoiOymEnJ/zidovudine-prescribing-information,Drugs for HIV / Anti-retroviral drugs,HIV infection,"Zidovudine, a nucleoside reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Prevention Of Maternal-Fetal HIV-1 Transmission Zidovudine is indicated for the prevention of maternal-fetal ... Read more
Zidovudine, a nucleoside reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Prevention Of Maternal-Fetal HIV-1 Transmission Zidovudine is indicated for the prevention of maternal-fetal HIV-1 transmission. The indication is based on a dosing regimen that included 3 components:
+
+- Antepartum therapy of HIV-1–infected mothers
+- Intrapartum therapy of HIV-1–infected mothers
+- Post-partum therapy of HIV-1–exposed neonate
+
+Points to consider prior to initiatingZidovudine in pregnant women for the prevention of maternal-fetal HIV-1 transmission include:
+
+- In most cases,Zidovudine for prevention of maternal-fetal HIV-1 transmission should be given in combination with other antiretroviral drugs.
+- Prevention of HIV-1 transmission in women who have receivedZidovudine for a prolonged period before pregnancy has not been evaluated.
+- Because the fetus is most susceptible to the potential teratogenic effects of drugs during the first 10 weeks of gestation and the risks of therapy withZidovudine during that period are not fully known, women in the first trimester of pregnancy who do not require immediate initiation of antiretroviral therapy for their own health may consider delaying use; this indication is based on use after 14 weeks’ gestation.
+
","Drugs for HIV / Anti-retroviral drugs
","Zidovudine is converted intracellularly to zidovudine triphosphate, which inhibits replication of retroviruses, including HIV, by interfering with viral RNA-directed DNA polymerase (reverse transcriptase).
","Prophylaxis of HIV infection in neonates:
+
+- Child: 2 mg/kg 6 hrly, starting within 12 hr after birth and continuing for 6 wk.
+
+HIV infection:
+
+- Adult: 250 mg or 300 mg bid, in combination with other antiretroviral agents.
+- Child: As soln: 4 to <9 kg: 12 mg/kg bid; 9 to <30 kg: 9 mg/kg bid; ≥30 kg: 250 mg or 300 mg bid. As cap/tab: 8-13 kg: 100 mg bid; 14-21 kg: 100 mg in the morning, 200 mg in the evening; 22-30 kg: 200 mg bid; ≥30 kg: 250 mg or 300 mg bid. Alternatively (based on BSA), 480 mg/m2 daily in 2-3 divided doses. Doses are given in combination with other antiretroviral agents.
+
+Prophylaxis of maternal-fetal HIV transmission:
+
+- Adult: 100 mg 5 times daily, starting on the 14th wk of gestation until the start of labour.
+
","May be taken with or without food.
","Decreased plasma concentration with rifampicin resulting in partial or total loss of efficacy of zidovudine. Increased risk of anaemia with ribavirin in patients co-infected with HCV. Antagonistic effect with stavudine or doxorubicn. Increased plasma level with probenecid, atovaquone, valproic acid, fluconazole, or methadone. May alter phenytoin blood levels. Increased adverse effect with potentially nephrotoxic or myelosuppressive drugs (e.g. systemic pentamidine, dapsone, pyrimethamine, co-trimoxazole, amphotericin, flucytosine, ganciclovir, interferon, vincristine, vinblastine, doxorubicin). Reduced absorption with clarithromycin.
","Hypersensitivity; abnormally low neutrophil counts (<0.75 x 109/L) or Hb levels (<7.5 g/dL or 4.65 mmol/L); newborn infants with hyperbilirubinaemia requiring treatment other than phototherapy, or with increased transaminase levels >5 times the ULN. Lactation. Concomitant use with interferon alfa (with or witho ribavirin) in HIV and hepatitis B or C virus co-infected patients.
","Dizziness, headache, malaise, myalgia, GI symptoms (e.g. abdominal pain, diarrhoea, nausea, vomiting), anorexia, immune reconstitution syndrome, lipodystrophy, metabolic abnormalities, mitochondrial dysfunction, osteonecrosis; raised liver enzymes, creatine phosphokinase; hyperbilirubinaemia, myalgia, myositis. Rarely, aplastic anaemia, pure red cell aplasia, pancytopenia, thrombocytopenia, rhabdomyolysis, cardiomyopathy, convulsions, pancreatitis.
","Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
","Severe renal and hepatic impairment. Childn. Pregnancy.
","Renal Impairment:
+
+- ESRD maintained on haemodialysis or peritoneal dialysis: 100 mg 6-8 hrly.
+- CrCl <10-15 mL/min: 100 mg 6-8 hrly.
+
+Hepatic Impairment: Dose reduction may be needed.
","Symptoms: Vomiting, CNS effects (e.g. fatigue, dizziness, drowsiness, lethargy, confusion), haematologic effects (e.g. anaemia, decreased Hb). Bone marrow hypoplasia, mild ataxia, tonic-clonic seizure and increased serum concentration of AST and ALT may also occur.
Management: Supportive and symptomatic treatment. Induce emesis and admin activated charcoal to prevent further absorption of unrecovered drug.
",,,"Store between 15-25° C.
",13
+1142,Zaleplon,zaleplon-1142,https://medex.com.bd/attachments/24T00KSig2Ky3s3Yjd20NtYUnsHOA3/zaleplon-prescribing-information,Benzodiazepine hypnotics,Insomnia and sleep disturbances,"Zaleplon is indicated for the short-term treatment of insomnia. Zaleplon has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical trials.
","Benzodiazepine hypnotics, Benzodiazepine sedatives
","Zaleplon is a newer non-benzodiazepine hypnotic from the pyrazolopyrimidine class. So, its chemical structure is unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties. It interacts with the gamma aminobutyric acid-benzodiazepine (GABA-BZ) receptor complex.
","The dose of Zaleplon should be individualized. The recommended dose of Zaleplon for most non elderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of Zaleplon appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for occasional patient who does not benefit from a trial of lower dose. Dosage above 20 mg has not been adequately evaluated and is not recommended.
Zaleplon should be taken immediately before bedtime. Taking Zaleplon with or immediately after a heavy, high fat meal results in slower absorption and would be expected to reduce the effect of Zaleplon on sleep latency. Elderly patients and debilitated patients appear to be more sensitive to the effects of hypnotic, and respond to 5 mg of Zaleplon. The recommended dose for these patients is therefore 5 mg, doses over 10 mg are not recommended.
For patients with mild to moderate renal impairment, no dose adjustment is necessary.
An initial dose of 5 mg should be given to patients concomitantly taking Cimetidine because Zaleplon clearance is reduced in this population.
Pediatric use: The safety and effectiveness of Zaleplon in pediatric patients have not been established.
",,"Zaleplon has been shown to have minimal effects on the kinetic of Warfarin, Imipramine, Ethanol, Ibuprofen, Diphenhydramine, Thioridazine, and Digoxin.
","Zaleplon is contraindicated in patients with known hypersensitivity to any of its components.
","Side effects of Zaleplon appear to be dose related. So, it is important to use the lowest possible effective dose, specially in the elderly. The side effects are usually mild and transient, the most common are diarrhoea, nausea, vomiting, vertigo, headache, asthenia, nightmare etc.
","Pregnancy: There are no studies of Zaleplon in pregnant women; therefore, it is not recommended for use in women during pregnancy. Zaleplon has no established use in labour and delivery.
Lactation: A study in lactating mothers indicated that the clearance and half-life of Zaleplon is similar to that in young normal subjects. A small amount of Zaleplon is excreted in breast milk, with the highest excreted amount occurring during a feeding at approximately 1 hour after Zaleplon administration. Since the small amount of the drug from breast milk may result in potentially important concentrations in infants, and because the effects of Zaleplon on a nursing infant are not known, it is not recommended in nursing mothers.
","Timing of drug administration: Zaleplon should be taken immediately before bedtime or after the patient has gone to bed.
Use in the elderly and/or debilitated patients: Impaired motor and/or cognitive performance after repeated exposure or unusual sensitivity to sedative/hypnotic drugs is a concern in the treatment of elderly and/or debilitated patients. A dose of 5 mg is recommended for elderly patients to decrease the possibility of side effects. Elderly and/or debilitated patients should be monitored closely.
Use in patients with concomitant illness: Zaleplon should be used with caution in patients with diseases or conditions that could affect metabolism or haemodynamic responses. Although preliminary studies did not reveal respiratory depressant effects at hypnotic doses of Zaleplon in normal subjects, caution should be observed if Zaleplon is prescribed to patients with compromised respiratory function, because sedative/hypnotic have the capacity to depress respiratory drive. However, patients with compromised respiration due to preexisting illness should be monitored carefully. The dose of Zaleplon should be reduced to 5 mg in patients with mild to moderate hepatic impairment. It is not recommended for use in patients with severe hepatic impairment.
Renal impairment patients: No dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment.
Use in patients with depression: As with other sedative or hypnotic drugs, Zaleplon should be administered with caution to patients exhibiting signs or symptoms of depression
",,,,,"Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
",10
+1141,Zafirlukast,zafirlukast-1141,https://medex.com.bd/attachments/mXD5dNKRSNsqPjcEXd7wwRxiQ0CKjz/zafirlukast-prescribing-information,Leukotriene receptor antagonists,Chronic asthma,"Zafirlukast is indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.
","Leukotriene receptor antagonists
","Zafirlukast is a selective and competitive leukotriene-receptor antagonist (LTRA) of leukotriene D4 and E4 (LTD4 and LTE4), components of slow-reacting substance of anaphylaxis (SRSA). Cysteinyl leukotriene production and receptor occupation have been correlated with the pathophysiology of asthma, including airway oedema, smooth muscle constriction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.
","Zafirlukast should be taken continuously.
Children under 7 years of age: There is no clinical experience of the use of Zafirlukast in children under 7 years of age until safety information is available.
Children over 7 years through 11 years of age: The recommended dose of Zafirlukast in this age group is 10 mg twice daily.
Adult and children aged 12 years and over: The dosage is one 20 mg tablet twice daily. This dosage should not be exceeded. Higher doses may be associated with elevations of one or more liver enzymes consistent with hepatotoxicity. As food may reduce the bioavailability of Zafirlukast, Zafirlukast should not be taken with meals
Elderly: The clearance of Zafirlukast is significantly reduced in elderly patients (over 65 years old), and Cmax and AUC are approximately double than those of younger adults. However, accumulation of Zafirlukast is not greater than that seen in multiple dose trials conducted in adult subjects with asthma and the consequences of the altered kinetic in the elderly are unknown. Clinical experience with Zafirlukast in the elderly (over 65 years) is limited and caution is recommended until further information is available.
Renal impairment: No dosage adjustment is necessary in patients with mild renal impairment.
",,"Zafirlukast may be administered with other therapies routinely used in the management of asthma and allergy. Inhaled steroids, inhaled and oral bronchodilator therapy, antibiotics and antihistamines are examples of agents which have been co-administered with Zafirlukast without adverse interaction.
Zafirlukast may be administered with oral contraceptives without adverse interaction. Co-administration with Warfarin results in an increase in maximum prothrombin time by approximately 35%. It is therefore recommended that if Zafirlukast is co-administered with Warfarin, prothrombin time should be closely monitored. The interaction is probably due to an inhibition by Zafirlukast of the cytochrome P450 2C9 enzyme system. In clinical trials co-administration with Theophylline resulted in decreased plasma levels of Zafirlukast, by approximately 30%, but with no effect on plasma Theophylline levels. However, during postmarketing surveillance, there have been rare cases of patients experiencing increased Theophylline levels when co-administered with Zafirlukast.
Co-administration with Terfenadine resulted in a 54% decrease in AUC for Zafirlukast, but with no effect on plasma Terfenadine levels. Coadministration with Acetylsalicylic acid (650 mg four times a day) may result in increased plasma levels of Zafirlukast, by approximately 45%.
Co-administration with Erythromycin will result in decreased plasma levels of Zafirlukast, by approximately 40%. The clearance of Zafirlukast in smokers may be increased by approximately 20%
","Zafirlukast should not be given to patients who have previously experienced hypersensitivity to the product or any of its ingredients. Zafirlukast is contraindicated in patients with a history of moderate or severe renal impairment. Zafirlukast is contraindicated in patients with hepatic impairment or cirrhosis; it has not been studied in patients with hepatitis or in long term studies of patients with cirrhosis. Zafirlukast is contraindicated in children under 7 years of age until safety information is available.
","Effect on ability to drive or operate machinery: There is no evidence that Zafirlukast affects the ability to drive and use machinery. Administration of Zafirlukast in clinical trials against placebo has been associated with headache (9.9% vs. 9.0%) or gastrointestinal disturbance (nausea 2.6% vs. 2.2%, vomiting 1.2% vs. 1.0%, diarrhoea 2.3% vs. 1.8%, abdominal pain 1.6% vs. 1.2%). These symptoms are usually mild and do not necessitate withdrawal from therapy. During post-marketing experience, bruising, bleeding disorders, including menorrhagia (rare), thrombocytopaenia and agranulocytosis (very rare) have also been reported.
Hypersensitivity reactions, including urticaria and angio-oedema have been reported. Rashes, including blistering, have also been reported. The above events have usually resolved during continued treatment or following cessation of therapy.
Infrequently, elevated serum transaminase levels have been observed in clinical trials against placebo with Zafirlukast (increased AST 1.0% vs. 0.9%, increased AST 0.6% vs. 0.6%); at recommended doses the incidence was equivalent to placebo. Rarely the transaminase profile has been consistent with drug-induced hepatitis, which resolved following cessation of Zafirlukast therapy. During post-marketing experience there have been rare reports of hepatitis, with or without elevated bilirubin levels. These cases were usually reversible.
In placebo controlled clinical trials, an increased incidence of infection has been observed in elderly patients given Zafirlukast (7.8% vs. 1.4%). Infections were usually mild, predominantly affecting the respiratory tract.
","Pregnancy: The safety of Zafirlukast in human pregnancy has not been established. In animal studies, Zafirlukast did not have any apparent effect on fertility and did not appear to have any teratogenic or selective toxic effect on the foetus. The potential risks should be weighed against the benefits of continuing therapy during pregnancy and Zafirlukast should be used during pregnancy only if clearly needed.
Lactation: Zafirlukast is excreted in human breast milk. Zafirlukast should not be administered to nursing mothers.
","Zafirlukast should be taken regularly to achieve benefit, even during symptom free periods. Zafirlukast therapy should normally be continued during acute exacerbations of asthma. Zafirlukast does not allow a reduction in existing steroid treatment. As with inhaled steroids and hormones (disodium cromoglycate, nedocromil sodium), Zafirlukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks. Zafirlukast has not been evaluated in the treatment of labile (brittle) or unstable asthma.
Cases of Churg Strauss syndrome have been reported in association with Zafirlukast usage. A causal relationship has neither been confirmed nor refuted. If a patient develops a Churg Strauss syndrome type illness, Zafirlukast should be stopped, a re-challenge test should not be performed and treatment should not be restarted.
Elevations in serum transaminases can occur during treatment with Zafirlukast. These are usually asymptomatic and transient but could represent early evidence of hepatotoxicity.
If clinical symptoms or signs suggestive of liver dysfunction occur (e.g., nausea, vomiting, right upper quadrant pain, fatigue, lethargy, flu-like symptoms, enlarged liver, pruritus and jaundice), the serum transaminases, in particular serum ALT, should be measured and the patient managed accordingly. A decision to discontinue Zafirlukast should be individualized to the patient’s condition, weighing the risk of hepatic dysfunction against the clinical benefit of Zafirlukast to the patient.
",,,,,"Store between 20-25° C. Protect from light and moisture.
",10