Category

• Bronchodilator

Description

Theophylline, ephedrine, and phenobarbital (thee-OFF-i-lin, e-FED-rin, and fee-noe-BAR-bi-tal) combination is used to treat the symptoms of bronchial asthma, asthmatic bronchitis, and other lung diseases. 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.

Before Using This Medicine

For theophylline, ephedrine, and phenobarbital combination medicine, the following should be considered:

Allergies--Tell your doctor if you have ever had any unusual or allergic reaction to aminophylline, caffeine, dyphylline, oxtriphylline, theobromine, or theophylline; to ephedrine or medicines like ephedrine such as albuterol, amphetamines, epinephrine, isoproterenol, metaproterenol, norepinephrine, phenylephrine, phenylpropanolamine, pseudoephedrine, or terbutaline; or to phenobarbital or other barbiturates. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

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

Pregnancy--Theophylline is used to treat asthma in pregnant women. Although there are no studies on birth defects in humans, problems have not been reported. However, some studies in animals have shown that theophylline can cause birth defects when given in doses many times the human dose.

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

Phenobarbital taken during pregnancy has been shown to increase the chance of birth defects in humans. Also, taking phenobarbital regularly during the last 3 months of pregnancy may cause the baby to become dependent on the medicine. This may lead to withdrawal symptoms in the baby after birth. In addition, one study in humans has suggested that phenobarbital taken during pregnancy may increase the chance of brain tumors in the baby.

Breast-feeding--Theophylline, ephedrine, and phenobarbital pass into the breast milk and may cause unwanted effects such as drowsiness, irritability, fretfulness, or trouble in sleeping in nursing babies of mothers taking this medicine.

Children--Newborn infants may be especially sensitive to the effects of theophylline, ephedrine, and phenobarbital combination medicine. This may increase the chance of side effects during treatment.

Older adults--Patients older than 60 years of age may be especially sensitive to the effects of theophylline, ephedrine, and phenobarbital combination medicine. This may increase the chance of side effects during treatment.

Other medicines--Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking theophylline, ephedrine, and phenobarbital combination medicine, it is especially important that your health care professional know if you are taking any of the following:

• Anticoagulants (blood thinners) or
• Carbamazepine or
• Corticosteroids (cortisone-like medicines) or
• Corticotropin--The effects of these medicines may be decreased by phenobarbital

• 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])--These medicines may prevent theophylline from working properly

• Carbamazepine or
• Divalproex sodium or
• Valproic acid--Using these medicines with phenobarbital may change the amount of any of these medicines that you need to take

• Central nervous system (CNS) depressants--The effects of these medicines or phenobarbital may be increased

• 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 the effects of theophylline

• Cocaine or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Norpramin], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])--The effects of ephedrine on the heart and blood vessels may be increased

• Guanadrel or
• Guanethidine or
• Methyldopa (e.g., Aldomet)--These medicines may increase the chance of high blood pressure caused by ephedrine

• Medicines that lower the acidity of urine, such as antacids containing calcium or magnesium, carbonic anhydrase inhibitors (e.g., Diamox, Neptazine), citrates (e.g., Bicitra, Polycitra), or sodium bicarbonate (e.g., baking soda)--These medicines may increase the chance of side effects of ephedrine

• Monoamine oxidase (MAO) inhibitors (furazolidone [e.g., Furoxone], isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], tranylcypromine [e.g., Parnate])--Taking ephedrine while you are taking or within 2 weeks of taking monoamine oxidase (MAO) inhibitors may increase the effects of MAO inhibitors

• Moricizine (e.g., Ethmozine) or
• Phenytoin (e.g., Dilantin) or
• Rifampin (e.g., Rifadin)--These medicines may decrease the effects of theophylline

• Oral contraceptives (birth control pills) containing estrogen--Phenobarbital may decrease the birth control effects of these medicines; use of another method of birth control may be necessary while you are taking this combination medicine

• Rauwolfia alkaloids (e.g., reserpine)--These medicines may prevent ephedrine from working properly

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

• Angle-closure glaucoma or
• Convulsions (seizures) or
• Heart or blood vessel disease or
• High blood pressure or
• Underactive adrenal gland--This combination medicine may make the condition worse

• Diabetes mellitus (sugar diabetes)--Phenobarbital may make the condition worse; your doctor may need to change the dose of your diabetes medicine

• History of drug abuse or
• Liver disease--The effects of phenobarbital or theophylline may be increased

• Kidney disease--The effects of phenobarbital may be increased

• Pain--Phenobarbital may cause unusual excitement in the presence of pain

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 your doctor may want you to take this medicine with meals or right after meals to lessen stomach upset. If you have any questions about how you should be taking this medicine, check with your doctor.

Take this medicine only as directed . Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of serious side effects. Also, if too much is taken, the phenobarbital in this medicine may become habit-forming.

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

Dosing--The dose of theophylline, ephedrine, and phenobarbital combination will be different for different patients. Follow your doctor's orders or the directions on the label .

Missed dose--If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed 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 tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

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

The phenobarbital in this combination medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; other barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine .

A change in your usual behavior or physical well-being may affect the way this medicine works in your body. Check with your doctor if you :

• have a fever of 102 °F or higher for at least 24 hours or higher than 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 shows how well blood is flowing to your heart), tell the medical doctor in charge that you are taking this medicine. The results of the test may be affected by this medicine.

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert .

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 may need medical attention.

Check with your doctor as soon as possible if any of the following side effects 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 medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your health care professional if any of the following side effects continue or are bothersome:

Less common

Chest discomfort or pain; drowsiness; fast heartbeat; headache; muscle cramps; nausea; nervousness or restlessness; trembling; trouble in sleeping

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

Revised: 12/30/97

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