THEOPHYLLINE, EPHEDRINE, AND HYDROXYZINE (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Marax
• Marax-DF

† Not commercially available in Canada.

Category

• Bronchodilator

Description

Theophylline, ephedrine , and hydroxyzine (thee-OFF-i-lin, e-FED-rin, and hye-DROX-i-zeen) combination medicine is used to treat or prevent the symptoms of asthma or to treat chronic bronchitis and 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 the following dosage forms:

• Oral
• Syrup (U.S.)
• Tablets (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 will do. This is a decision you and your doctor will make. For theophylline, ephedrine, and hydroxyzine combination medicine, the following should be considered:

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

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.

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

Ephedrine has been shown to cause birth defects in humans when used during the first trimester.

Hydroxyzine is not recommended during the first months of pregnancy because it has been shown to cause birth defects in rats when given in doses up to many times the usual human dose.

Breast-feeding—Theophylline and ephedrine pass into breast milk and may cause unwanted effects such as irritability in babies of mothers taking this medicine. Hydroxyzine has been reported to cause unusual excitement or irritability in nursing babies.

Children—Theophylline, ephedrine, and hydroxyzine combination medicine is not recommended for use in children up to 2 years of age. Although there is no specific information about the use of theophylline, ephedrine, and hydroxyzine combination medicine in children 2 years of age and older, it is not expected to cause different side effects or problems in these children than it does in adults.

Older adults—Patients older than 60 years of age may be especially sensitive to the effects of theophylline, ephedrine, and hydroxyzine 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 hydroxyzine combination medicine, it is especially important that 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])—These medicines may prevent theophylline from working properly

• Central nervous system (CNS) depressants (medicines that cause drowsiness)—The effects of these medicines or hydroxyzine 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) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], 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

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

• Smoking tobacco or marijuana—Starting or stopping smoking may change the effectiveness of theophylline

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

• Coronary insufficiency—Ephedrine may make the condition worse

• Enlarged prostate or
• Urinary tract blockage or difficult urination—Hydroxyzine may make urinary problems worse

• Glaucoma—Ephedrine and hydroxyzine may make the condition worse

• Heart failure or
• Liver disease or
• Underactive thyroid—The effects of theophylline may be increased

• High blood pressure—Use of ephedrine may cause severe high blood pressure

• Convulsions (seizures)—Theophylline may make this condition worse

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 your doctor ordered. To do so may increase the chance of serious side 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 the blood. To help keep the amount constant, do not miss any doses.

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.

Dosing—The dose of theophylline, ephedrine, and hydroxyzine combination will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of theophylline, ephedrine, and hydroxyzine combination. If your dose is different, do not change it unless your doctor tells you to do so.

• For symptoms of bronchial asthma, chronic bronchitis, emphysema, or other lung disease:
  • For syrup dosage form:
    • Adults—20 milliliters (mL) (4 teaspoonfuls) two to four times a day.
    • Children 5 years of age and over—5 mL (1 teaspoonful) three or four times a day.
    • Children 2 to 5 years of age—2.5 to 5 mL (one-half to 1 teaspoonful) three or four times a day.
    • Children up to 2 years of age—Use is not recommended.
  • For tablet dosage form:
    • Adults—One tablet two to four times a day.
    • Children 5 years of age and over: One-half tablet two to four times a day.
    • Children up to 5 years of age: Use is not recommended.

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.
• Keep the syrup form of this medicine from freezing.
• 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

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

The theophylline in this medicine may add to the central nervous system (CNS) 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 hydroxyzine in this medicine will add to the effects of alcohol and 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; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including dental anesthetics. Check with your doctor before taking any of the above while you are taking 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 taking another medicine.
• start or stop smoking.
• 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:

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 doctor if any of the following side effects continue or are bothersome:

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

Revised: 12/23/1997