Teva-Combo Sterinebs
(ipratropium - salbutamol inhalation)
02272695 TEVA-COMBO STERINEBS Inhalation solution
Salbutamol and ipratropium belong to the family of medications known as bronchodilators. Together, they are used to treat chronic obstructive pulmonary disease (COPD), a chronic lung disease that makes it difficult to breathe. These medications work in different ways to open the airways and make breathing easier.
Each 2.5 mL unit-dose package contains 3.0 mg salbutamol sulfate (equivalent to 2.5 mg salbutamol base) and 0.5 mg ipratropium bromide anhydrous (as monohydrate). Nonmedicinal ingredients: sodium chloride and hydrochloric acid.
The inhalation solution is designed for use with a nebulizer, a machine that delivers medications to the lungs by pumping the medication through a mask or mouthpiece. The usual dose is one vial 3 or 4 times a day. Each vial should be used only once and then discarded.
Do not use the inhalation solution if it is discoloured. Do not allow the medication to enter your eyes. If contact occurs, flush your eyes with plenty of water.
It is important to use this medication on a regular schedule as prescribed by your doctor. If you miss a dose of this medication, and no respiratory symptoms occur, then skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you miss a dose and respiratory symptoms occur, then take the missing dose and continue with your regular dosing schedule. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Do not use ipratropium - salbutamol inhalation solution if you:
are allergic to salbutamol, ipratropium, or any ingredients of this medication
are allergic to atropine or related medications
have certain types of abnormal heart rhythms (tachyarrhythmias)
have certain types of heart disease (hypertrophic obstructive cardiomyopathy)
change in taste sensation
common cold (runny nose, nasal congestion, sore throat)
throat irritation
voice changes
changes in blood pressure (e.g., dizziness, fainting, lightheadedness)
feeling nervous
muscle pain, weakness, or spasms
severe dizziness
symptoms of glaucoma (e.g., blurred vision, seeing halos of bright colours around lights, red eyes, increased pressure in your eyes, eye pain or discomfort)
symptoms of a respiratory infection (e.g., shortness of breath, cough, chest pain)
wheezing after inhalation
sudden blurred vision or eye pain
fast or irregular heartbeat
increased shortness of breath or wheezing
signs of heart attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)
signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
skin rash or hives
Cystic fibrosis: People with cystic fibrosis may be more likely to have stomach discomfort (due to changes in how quickly food moves through the stomach and intestines) while using this medication.
Diabetes: Ipratropium – salbutamol inhalation solution may cause an increase in blood sugar levels (may cause a loss of blood glucose control) and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.
If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Dizziness/blurred vision: Ipratropium - salbutamol may cause dizziness or blurred vision, affecting your ability to safely drive or operate machinery. Avoid these and other hazardous tasks until you know how this medication affects you.
Heart conditions: This medication can cause increased heart rate and blood pressure, making certain heart conditions worse. If you have heart disease, high blood pressure, irregular heart beat, heart failure, or have had a recent heart attack, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Inhalation-induced bronchospasm: Inhaled forms of medications may cause spasms of the airways, which make breathing difficult. If you experience this problem when using ipratropium - salbutamol, stop using this medication immediately. Speak to your doctor if you experience any problems with breathing while taking this or other inhaled medications.
Pheochromocytoma: If you have been diagnosed with pheochromocytoma (a tumour of the adrenal gland), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Potassium levels: Decreases in blood levels of potassium may occur with the use of this medication. This rarely causes problems, but potassium levels should be monitored by your doctor. If you experience unexplained muscle cramps, weakness, fatigue, or constipation, contact your doctor.
Thyroid disease: People who have an over-active thyroid gland may be more sensitive to the effects of ipratropium - salbutamol. If you have thyroid disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Urinary tract problems: Ipratropium – salbutamol inhalation solution can cause difficulty with starting urine flow. If you have an enlarged prostate or bladder retention, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Vision concerns: This medication may cause symptoms of glaucoma or cause existing glaucoma to become worse. Avoid spraying this medication into your eyes. If this happens, rinse your eyes with clear water immediately. Report any changes in your vision, including blurred vision, halos, and eye pain, to your doctor immediately.
Worsening symptoms: If this medication does not begin to help your symptoms quickly, or you find that you have increased difficulty breathing, or you need to use this medication more frequently, contact your doctor immediately.
Pregnancy: The safety of ipratropium – salbutamol inhalation solution use during pregnancy has not been determined. Although this medication should not be used during pregnancy unless the benefits outweigh the risks, sometimes the benefit to the mother does outweigh risks to the developing baby. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if ipratropium – salbutamol inhalation solution passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.
There may be an interaction between ipratropium – salbutamol inhalation solution and any of the following:
aclidinium
amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
atomoxetine
benztropine
beta-blockers (e.g., propranolol, nadolol)
betahistine
fast acting bronchodilators (e.g., salbutamol, terbutaline)
long acting bronchodilators (e.g., formoterol, salmeterol)
corticosteroids (e.g., cortisone, prednisone)
darifenacin
decongestant cold medications (e.g., phenylephrine, pseudoephedrine)
decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
dipivefrin
disopyramide
diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
donepezil
efavirenz
flavoxate
glycopyrrolate
HIV protease inhibitors (e.g., darunavir, indinavir, lopinavir, saquinavir, tipranavir)
ketotifen
methylphenidate
midodrine
mirabegron
monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, rasagiline, selegiline, tranylcypromine)
narcotics (e.g., codeine, morphine, oxycodone)
orphenadrine
oxybutynin
primaquine
quinidine
quinolone antibiotics (e.g., levofloxacin, moxifloxacin, ofloxacin)
rivastigmine
secretin
selective serotonin reuptake inhibitors (SSRI; e.g., fluoxetine, paroxetine, sertraline)
serotonin antagonists (anti-emetic medications; e.g., granisetron, ondansetron)
solifenacin
tetrabenazine
theophyllines (e.g., aminophylline, oxtriphylline, theophylline)
tiotropium
tolterodine