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USP DI Vol. II - THEOPHYLLINEAND GUAIFENESIN (Systemic)

THEOPHYLLINEAND GUAIFENESIN (Systemic)?


Some commonly used brand names are:

In the U.S.?

  • Bronchial
  • Broncomar GG
  • Ed-Bron G
  • Elixophyllin-GG
  • Equibron G
  • Glyceryl-T
  • Quibron
  • Quibron-300
  • Slo-Phyllin GG
  • Theolate
  • Theocon

Generic name product may be available in the U.S.

Another commonly used name is theophyllineand glyceryl guaiacolate.

? Not commercially available in Canada.


Category

  • Bronchodilator

Description

Theophylline and guaifenesin (thee-OFF-i-lin and gwye-FEN-e-sin) combinationis used to treat or prevent the symptoms of asthma or to treat chronic bronchitisand emphysema. This medicine relieves cough, wheezing, shortness of breath,and troubled breathing. It works by opening up the bronchial tubes (air passages)of the lungs and increasing the flow of air through them.

This medicine is available only with your doctor's prescription, in thefollowing dosage forms:

    Oral
  • Capsules (U.S.)
  • Elixir (U.S.)
  • Oral solution (U.S.)
  • Syrup (U.S.)


Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For theophylline andguaifenesin combination medicine, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to aminophylline, guaifenesin, oxtriphylline, or theophylline.

Pregnancy?Theophylline is used to treat asthmain pregnant women. Although there are no studies on birth defects in humans,problems have not been reported. However, some studies in animals have shownthat theophylline can cause birth defects when given in doses many times thehuman dose.

Because your ability to clear theophylline from your body may decreaselater in pregnancy, your doctor may want to take blood samples during yourpregnancy to measure the amount of medicine in the blood. This will help yourdoctor decide whether the dose of this medicine should be changed.

Theophylline crosses the placenta. Use of this medicine during pregnancymay cause unwanted effects, such as fast heartbeat, irritability, jitteriness,or vomiting, in the newborn infant if the amount of medicine in your bloodis too high.

Several groups of women taking guaifenesin during pregnancy have been studied.In one group, when guaifenesin was taken during the first 3 months of pregnancy,the babies had more inguinal hernias than expected. However, more birth defectsthan expected did not occur in the babies of other groups of women takingguaifenesin during pregnancy. Studies with guaifenesin have not been donein animals.

Breast-feeding?Theophylline passes into breast milk and may causeirritability in babies of mothers taking this medicine. Guaifenesin has notbeen reported to cause problems in nursing babies.

Children?The side effects of theophylline are more likelyto occur in newborn infants, who are usually more sensitive to the effectsof this medicine.

Although there is no specific information about the use of guaifenesinin children, it is not expected to cause different side effects or problemsin children than it does in adults.

Older adults?Patients older than 60 years of age are likely torequire a lower dose than younger adults. If the amount of theophylline istoo high, side effects are more likely to occur. Your doctor may want to take blood samples to determine whether a dose change is needed.

Although there is no specific information about the use of guaifenesinin the elderly, it is not expected to cause different side effects or problemsin older people than it does in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingtheophylline and guaifenesin combination medicine, it is especially importantthat your health care professional know if you are taking any of the following:

  • Beta-adrenergic blocking agents including those used in the eyes(acebutolol [e.g., Sectral], atenolol [e.g., Tenormin], betaxolol [e.g., Betoptic,Kerlone], bisoprolol [e.g., Zebeta], carteolol [e.g., Cartrol], labetalol[e.g., Normodyne], levobunolol [e.g., Betagan], metipranolol [e.g., OptiPranolol],metoprolol [e.g., Lopressor], nadolol [e.g., Corgard], oxprenolol [e.g., Trasicor],penbutolol [e.g., Levatol], pindolol [e.g., Visken], propranolol [e.g., Inderal],sotalol [e.g., Sotacor], timolol [e.g., Blocadren, Timoptic])?Thesemedicines may prevent theophylline from working properly
  • Cimetidine (e.g., Tagamet) or
  • Ciprofloxacin (e.g., Cipro) or
  • Clarithromycin (e.g., Biaxin) or
  • Enoxacin (e.g., Penetrex) or
  • Erythromycin (e.g., E-Mycin) or
  • Fluvoxamine (e.g., Luvox) or
  • Mexiletine (e.g., Mexitil) or
  • Pentoxifylline (e.g., Trental) or
  • Tacrine (e.g., Cognex) or
  • Thiabendazole or
  • Ticlopidine (e.g., Ticlid) or
  • Troleandomycin (e.g., TAO)?These medicines may increase theeffects of theophylline
  • Moricizine (e.g., Ethmozine) or
  • Phenytoin (e.g., Dilantin) or
  • Rifampin (e.g., Rifadin)?These medicines may decrease the effectsof theophylline
  • Smoking tobacco or marijuana?Starting or stopping smoking maychange the effectiveness of this medicine

Other medical problems?The presence of other medicalproblems may affect the use of theophylline and guaifenesin combination medicine.Make sure you tell your doctor if you have any other medical problems, especially:

  • Convulsions (seizures)?Theophylline may make this conditionworse
  • Heart failure or
  • Liver disease or
  • Underactive thyroid?The effects of theophylline may be increased

Proper Use of This Medicine

This medicine works best when taken with a glass of water on an empty stomach (either 30 minutes to 1 hour before meals or 2 hours after meals)since that way it will get into the blood sooner. However, in some cases yourdoctor may want you to take this medicine with meals or right after mealsto lessen stomach upset. If you have any questions about how you should betaking this medicine, check with your doctor.

Take this medicine only as directed. Do nottake more of it, do not take it more often, and do not take it for a longertime than your doctor ordered. To do so may increase the chance of seriousside effects.

In order for this medicine to help your medical problem,it must be taken every day in regularly spaced doses as ordered by your doctor. This is necessary to keep a constant amount of this medicine in theblood. To help keep the amount constant, do not miss any doses.

Make certain your health care professional knows if you are on any specialdiet, such as a high-protein, low-carbohydrate or low-protein, high-carbohydratediet.

Dosing?When you are taking theophylline and guaifenesincombination, it is very important that you get the exact amount of medicinethat you need. The dose of this medicine will be different for different patients.Your doctor will determine the proper dose of the theophylline and guaifenesincombination for you. Follow your doctor's orders or thedirections on the label.

After you begin taking theophylline and guaifenesin combination, it isvery important that your doctor check your blood level of theophylline atregular intervals to find out if your dose of theophylline and guaifenesincombination needs to be changed. Do not change your doseof theophylline and guaifenesin combination unless your doctor tells you todo so.

The number of capsules or teaspoonfuls of elixir, solution, or syrup thatyou take depends on the strength of the medicine.

Missed dose?If you miss a dose of this medicine, take it assoon as possible. However, if it is almost time for your next dose, skip themissed dose and go back to your regular dosing schedule. Do not double doses.

Storage?To store this medicine:

  • Keep out of the reach of children.
  • Store away from heat and direct light.
  • Do not store the capsule form of this medicine in the bathroom, nearthe kitchen sink, or in other damp places. Heat or moisture may cause themedicine to break down.
  • Keep the liquid form of this medicine from freezing.
  • Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Your doctor should check your progress at regular visits,especially for the first few weeks after you begin taking this medicine. Ablood test may be taken to help your doctor decide whether the dose of thismedicine should be changed.

The theophylline in this medicine may add to the central nervous systemstimulant effects of caffeine-containing foods or beverages such as chocolate,cocoa, tea, coffee, and cola drinks. Avoid eating ordrinking large amounts of these foods or beverages while taking this medicine. If you have any questions about this, check with your doctor.

A change in your usual behavior or physical well-being may affect the waythis medicine works in your body. Check with your doctorif you:

  • have a fever of 102 ?F or higher for at least 24 hours or higherthan 100 ?F for longer than 24 hours.
  • start or stop smoking.
  • start or stop taking another medicine.
  • change your diet for a long time.

Before you have myocardial perfusion studies (a medical test that showshow well blood is flowing to your heart), tell the medical doctor in chargethat you are taking this medicine. The results of the test may be affectedby this medicine.


Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects.Although not all of these side effects may occur, if they do occur they mayneed medical attention.

Check with your doctor as soon as possible if any of the following sideeffects occur:

    Less common or rare

      Heartburn and/or vomiting

    Symptoms of toxicity

      Abdominal pain, continuing or severe; confusion or change in behavior; convulsions (seizures); dark or bloody vomit; diarrhea; dizziness or lightheadedness; fast and/or irregular heartbeat, continuing; nervousness or restlessness, continuing; trembling,continuing

Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects continue or are bothersome:

    Less common

      Fast heartbeat; headache; increased urination; nausea; nervousness; trembling; trouble in sleeping

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.


Revised: 12/23/1997