Dapoxetine Hydrochloride
ডেপক্সিটিন হাইড্রোক্লোরাইড একটি সিলেক্টিভ সেরোটনিন রিয়াপ্টেক ইনহিবিটর (এস.এস.আর.আই.)। ডেপক্সিটিন সেরোটনিন এর রিয়াপ্টেক বাধাগ্রস্থ করে এবং প্রি-সিন্যাপ্টিক ও পোস্ট-সিন্যাপ্টিক রিসেপ্টরে নিউরোট্রান্সমিটারের কার্যক্ষমতা বাড়িয়ে দ্রুত বীর্যপাত রোধ করে।
যৌনমিলনের ১-৩ ঘন্টা পূর্বে ৩০ মি.গ্রা. ট্যাবলেট।সর্বোচ্চ নির্দেশিত মাত্রা ৬০ মি.গ্রা. ট্যাবলেট।সর্বোচ্চ প্রয়োগবিধি দৈনিক ১ বার।
প্রোলং প্রাপ্তবয়স্ক পুরুষ (১৮ থেকে ৬৪ বছর বয়স) যাদের নিম্নোক্ত সমস্যাগুলো আছেঃন্যূনতম উত্তেজনায় রোগীর ইচ্ছার বিরুদ্ধে অনিয়ন্ত্রিত বীর্যপাত।যৌন মিলনের পূর্বেই অথবা মিলনের সাথে সাথে বীর্যপাত।দ্রুত বীর্যপাতের কারণে সৃষ্ট হতাশা।
ডেপক্সিটিন হাইড্রোক্লোরাইড এর প্রতি সংবেদনশীলতা আছে এমন রোগীদের ক্ষেত্রে।জটিল হৃদরোগ, জটিল ইস্কিমিক হার্ট ডিজিজ অথবা জটিল ভালভুলার হার্ট ডিজিজ।মনোএমাইন অক্সিডেজ ইনহিবিটর (MAOIs) কিংবা থায়োরিডাযিন এর সাথে প্রতিনির্দেশিত। মনোএমাইন অক্সিডেজ ইনহিবিটর কিংবা থায়োরিডাযিন বন্ধ করার ১৪ দিন পর ডেপক্সিটিন সেবন নির্দেশিত। ডেপক্সিটিন বন্ধ করার ৭ দিন পর মনোএমাইন অক্সিডেজ ইনহিবিটর কিংবা থায়োরিডাযিন সেবন নির্দেশিত।সিলেক্টিভ সেরোটনিন রিয়াপ্টেক ইনহিবিটর (SSRIs), সেরোটনিন-নর এপিনেফ্রিন রিয়াপ্টেক ইনহিবিটর (SNRIs), ট্রাইসাইক্লিক আন্টিডিপ্রেসেন্ট (TCAs) অথবা অন্যান্য ঔষধ/হারবাল উপাদান যারা সেরোটনিনের মত ফলাফল প্রদান করে এদের সাথে প্রতিনির্দেশিত। এই সকল ওষুধ বন্ধ করার ১৪ দিন পর ডেপক্সিটিন সেবন নির্দেশিত।
আলো ও আর্দ্রতা থেকে দূরে, ৩০°সে. তাপমাত্রায় অথবা এর নিচে রাখুন। শিশুদের নাগালের বাইরে রাখুন।
The mechanism of action of Dapoxetine in premature ejaculation is presumed to be linked to the inhibition of neuronal reuptake of serotonin and the subsequent potentiation of the neurotransmitter's action at pre-and post synaptic receptors. Human ejaculation is primarily mediated by the sympathetic nervous system. The ejaculatory pathway originates from a spinal reflex centre, mediated by the brain stem, which is influenced initially by a number of nuclei in the brain (medial preoptic and paraventricular nuclei).Dapoxetine is rapidly absorbed with maximum plasma concentrations (Cmax) occurring approximately 1-2 hours after tablet intake. The absolute bioavailability is 42%. More than 99% of Dapoxetine is bound in-vitro to human serum proteins. The active metabolite Desmethyl dapoxetine (DED) is 98.5% protein bound. Dapoxetine appears to have a rapid distribution with a mean steady state volume of distribution of 162 L.Dapoxetine is extensively metabolized to multiple metabolites primarily through the following biotransformational pathways: N-oxidation, N-demethylation, Naphthyl hydroxylation, Glucuronidation and Sulfation. There was evidence of presystemic first-pass metabolism after oral administration. The metabolites of the Dapoxetine were primarilly eliminated in urine as conjugates. Dapoxetine has a rapid elimitaion and the terminal half life is approximately 19 hours.
For Premature Ejaculation:Adult men (18 to 64 years of age): The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. The maximum recommended dosing frequency is once every 24 hours. If the effect of 30 mg is insufficient and the side effects are acceptable, the dose may be increased to the maximum recommended dose of 60 mg. Dapoxetine may be taken with or without food.Children and adolescents: Dapoxetine should not be used in individuals below 18 years of age. Elderly (age 65 years and over): Safety and efficacy of Dapoxetine have not been established in patients age 65 years and over as limited data are available in this population.Patients with renal impairment: Caution is advised in patients with mild or moderate renal impairment. Dapoxetine is not recommended for use in patients with severe renal impairment.Patients with hepatic impairment: Dapoxetine is contraindicated in patients with moderate and severe hepatic impairment
CNS active medicinal products: The use of Prolong in combination with CNS active medicinal products has not been systematically evaluated in patients with premature ejaculation. Consequently, caution is advised if the concomitant administration of Prolong and such medicinal products is required.PDE5 inhibitors: Tadalafil did not affect the pharmacokinetics of Prolong. Sildenafil caused slight changes in Prolong pharmacokinetics, which are not expected to be clinically significant. However, Prolong should be prescribed with caution in patients who use PDE5 inhibitors due to possible reduced orthostatic tolerance.Tamsulosin: Concomitant administration of single or multiple doses of 30 mg or 60 mg Prolong to patients receiving daily doses of Tamsulosin did not result in changes in the pharmacokinetics of Tamsulosin. However, Prolong should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance.Warfarin: There are no data evaluating the effect of chronic use of Warfarin with Prolong; therefore, caution is advised when Prolong is used in patients taking Warfarin chronically.Ethanol: Concomitant use of alcohol and Prolong could increase the chance or severity of adverse reactions such as dizziness, drowsiness, slow reflexes, or altered judgment. Combining alcohol with Prolong may increase these alcohol-related effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Prolong.
Patients with known hypersensitivity to Dapoxetine Hydrochloride.Patients with significant pathological cardiac conditions (such as heart failure (NYHA class ll-IV), conduction abnormalities (second- or third-degree AV block or sick sinus syndrome) not treated with a permanent pacemaker, significant ischemic heart disease or significant valvular disease.Concomitant treatment with monoamine oxidase inhibitors (MAOIs), thioridazine, or within 14 days of discontinuing treatment with MAOIs, thioridazine. Similarly, MAOIs, thioridazine should not be administered within 7 days after Dapoxetine has been discontinued.Concomitant treatment with serotonin reuptake inhibitors [selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs)] or other medicinal/herbal products with serotonergic effects or within 14 days of discontinuing treatment with these medicinal/herbal products.
The most common effects when taking Prolong are nausea, dizziness, dry mouth, headache, diarrhea, and insomnia. Discontinuation due to adverse effects is dose related. The rate of discontinuation is 0.3%, 1.7%, and 5.3% of 1067 studied subjects with placebo, Prolong 30 mg, and Prolong 60 mg respectively. Unlike others SSRIs used to treat depression, which have been associated with high incidences of sexual dysfunction, Prolong is associated with low rates of sexual dysfunction. Taken as needed, Prolong has very mild adverse effects on loss of libido (<1%) and ED (<4%).
Dapoxetine Hydrochloride is not indicated for use by women. It is not known either dapoxetine or its metabolites are excreted through human breast milk.
Use with recreational drugs: Patients should be advised not to use Prolong in combination with recreational drugs. Recreational drugs with serotonergic activity such as ketamine, methylenedioxymethamphetamine (MDMA) and lysergic acid diethylamide (LSD) may lead to potentially serious reactions if combined with Prolong. These reactions include, but are not limited to arrhythmia, hyperthermia, and serotonin syndrome. Use of Prolong with recreational drugs with sedative properties such as narcotics and benzodiazepines may further increase somnolence and dizziness.Ethanol: Combining alcohol with Prolong may increase alcohol-related neurocognitive effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Prolong.Syncope: Possibly prodromal symptoms such as nausea, dizziness, lightheadedness, palpitations, asthenia, confusion and diaphoresis generally occurred within the first 3 hours following dosing and often preceded the syncope. Patients need to be made aware that they could experience syncope at any time with or without prodromal symptoms during their treatment with Prolong.Orthostatic hypotension: An orthostatic test should be performed before initiating therapy. In case of a history of documented or suspected orthostatic reaction, treatment with Prolong should be avoided.Haemorrhage: There have been reports of bleeding abnormalities with SSRIs. Caution is advised in patients taking Prolong, particularly in concomitant use with medicinal products known to affect platelet function (e.g., atypical antipsychotics and phenothiazines, acetylsalicylic acid, nonsteroidal anti-inflammatory drugs [NSAIDs], anti-platelet agents) or anticoagulants (e.g., warfarin), as well as in patients with a history of bleeding or coagulation disorders.PDE5 inhibitors: The pharmacokinetics of Prolong (60 mg) in combination with Tadalafil (20 mg) and Sildenafil (100 mg) were evaluated in a single dose crossover study. Tadalafil and Sildenafil did not affect the pharmacokinetics of Prolong.Tamsulosin: Prolong should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance.
No case of overdose has been reported. There were no unexpected adverse events in a clinical pharmacology study of Prolong with daily doses up to 240 mg (two 120 mg doses given 3 hours apart). In general, symptoms of overdose with SSRIs include serotonin-mediated adverse reactions such as somnolence, gastrointestinal disturbances (such as nausea and vomiting), tachycardia, tremor, agitation and dizziness.Withdrawal effects: Clinical trial in subjects with PE designed to assess the withdrawal effects of 62 days of daily or as needed dosing with 60 mg Prolong showed no evidence of withdrawal syndrome.
Drugs for Erectile Dysfunction
Store below 30°C. Protect from light and moisture. Keep out of reach of children.
{'Indications': 'Prolong is indicated for the treatment of premature ejaculation (PE) in men 18 to 64 years of age, who have one or all of the following:Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes.Marked personal distress or interpersonal difficulty as a consequence of PE.Poor control over ejaculation.'}