GENERIC NAME: GUAIFENESIN/THEOPHYLLINE/PSEUDOEPHEDRINE ELIXIR - ORAL (gwye-FEN-e-sin/thee-OFF-ih-lin/SOO-doe-e-FED-rin)
BRAND NAME(S): Broncomar-1
USES: This medication contains 3 drugs (theophylline, guaifenesin, pseudoephedrine). It is used to treat and prevent wheezing and trouble breathing caused by ongoing lung disease (such as asthma, chronic bronchitis, emphysema). It is also used to treat a stuffy nose and sinus congestion that can occur with lung disease. Theophylline belongs to a class of drugs known as xanthines. It improves breathing by opening the air passages and decreasing the lungs' response to irritants. Guaifenesin is an expectorant that helps thin and loosen mucus in the lungs, making it easier to cough up the mucus. Pseudoephedrine is a decongestant and works by decreasing swelling in the nose, making it easier to breathe. Controlling symptoms of breathing problems can decrease time lost from work or school.This medication does not work immediately and should not be used to relieve sudden attacks of breathing trouble. If an attack occurs, use your quick-relief inhaler (such as albuterol) as prescribed by your doctor.
HOW TO USE: Take this medication by mouth, usually every 6 to 12 hours, with a full glass of water (8 ounces or 240 milliliters) or as directed by your doctor. If stomach upset occurs, take it with food. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.The dosage is based on your age, weight, medical condition, theophylline blood levels, response to treatment, and other drugs you may be taking. (See also Drug Interactions section.)Alcohol and caffeine can increase the side effects of this medication. Avoid drinking large amounts of beverages containing alcohol or caffeine (coffee, tea, colas), eating large amounts of chocolate, or taking nonprescription products that contain caffeine.This medication works best when the amount in your body is kept at a constant level. Therefore, use this medication at evenly spaced intervals. To help you remember, take it at the same times each day. Do not increase your dose unless your doctor directs you to do so. Taking too much of this medication may cause serious side effects.Be sure you understand which medications to use on a regular basis (controller drugs such as this medication) and which to use as needed for sudden attacks of breathing trouble (quick-relief medications). Consult your doctor about what you should do if your breathing worsens (for example, if you have increased coughing or shortness of breath, or if you wake up at night with breathing trouble).Also discuss what to do if this medication stops working well. Watch for signs of worsening breathing problems and report them to your doctor promptly. Your doctor may need to change your dose of controller medications or may prescribe other drugs that may work better for you. Signs of worsening breathing problems include needing to use your quick-relief inhaler more often (more than 2 days a week, more than 1 canister a month), or having peak flow meter readings in the yellow/red range. Get instructions from your doctor about when you can treat breathing problems by yourself and when you must seek immediate medical attention.
SIDE EFFECTS: Nausea, vomiting, headache, dizziness, trouble sleeping, diarrhea, irritability, nervousness, restlessness, shaking, pounding heartbeat, stomach pain/cramping, and difficulty urinating may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these rare but serious side effects occur: fast/irregular heartbeat, seizures.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to any of the ingredients; or to similar drugs (such as dyphylline, ephedrine, phenylephrine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as angina, fast/slow/irregular heartbeat, heart failure, recent heart attack), high blood pressure, stroke, blood circulation disease (such as Raynaud's disease, peripheral vascular disease), diabetes, kidney disease, liver disease, seizures, stomach/intestinal ulcer, thyroid problems (underactive or overactive), a certain lung problem (cystic fibrosis), fluid in the lungs, mental/mood disorder (such as anxiety), trouble sleeping (insomnia), glaucoma, enlarged prostate.Common illnesses may affect how this medication is removed from your body. Tell your doctor immediately if you develop a high fever (102 degrees F/39 degrees C or higher) that lasts for more than 24 hours. The dose of your medication may need to be adjusted.This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.Before having surgery, tell your doctor or dentist that you are using this medication.Older adults may be more sensitive to the side effects of this drug, especially fast/irregular heartbeat, dizziness, problems urinating, trouble sleeping, or confusion.This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.This medication passes into breast milk. However, it is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: riociguat.Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.Other medications can affect the removal of this medication from your body, which may affect how this medication works. Examples include cimetidine, disulfiram, fluvoxamine, interferon alpha, certain macrolide antibiotics (clarithromycin, erythromycin), mexiletine, nefazodone, St. John's wort, drugs to treat seizures (such as carbamazepine, phenobarbital, phenytoin), tacrine, zileuton, among others.Check the labels on all your medicines (such as cough-and-cold products, diet aids) because they may contain the same or similar ingredients (such as ephedrine, phenylephrine) that could increase the side effects of this medication. Ask your pharmacist about using those products safely.Also report the use of drugs which might increase seizure risk when combined with this medication including isoniazid (INH), phenothiazines (such as thioridazine), tramadol, tricyclic antidepressants (such as amitriptyline), among others. Consult your doctor or pharmacist for details.Cigarette smoking decreases blood levels of this medication. Tell your doctor if you smoke or if you have recently stopped smoking.This medication may interfere with certain laboratory tests (such as stress tests, uric acid levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this medication.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: agitation, severe vomiting, extreme thirst, ringing in the ears, increased sweating, slow/shallow breathing, fainting, chest pain, fast/irregular heartbeat, seizures.
NOTES: Do not share this medication with others.Avoid substances that can worsen breathing problems by causing irritation or allergic reaction, such as smoke, pollen, pet dander, dust, and mold.Laboratory and/or medical tests (such as theophylline blood levels) should be performed periodically to monitor your progress or check for side effects. It is important that you do not miss your medication or take extra doses for at least 2 days before your theophylline blood levels are checked. Consult your doctor for more details.To help loosen mucus, drink plenty of fluids while taking this medication unless your doctor instructs you otherwise.If you have asthma, learn to use a peak flow meter, use it daily, and promptly report worsening breathing problems (such as readings in the yellow/red range, increased use of quick-relief inhalers).Because the flu virus can worsen breathing problems, ask your doctor or pharmacist if you should have a flu shot every year.
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STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised December 2013. Copyright(c) 2013 First Databank, Inc.
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