BRONCHODILATORS,THEOPHYLLINE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Aerolate Sr ³
• Asmalix ³
• Choledyl ²
• Choledyl SA ²
• Elixophyllin ³
• Lanophyllin ³
• Phyllocontin ¹
• Quibron-T Dividose ³
• Quibron-T/SR Dividose ³
• Respbid ³
• Slo-Bid Gyrocaps ³
• Slo-Phyllin ³
• Theo-24 ³
• Theobid Duracaps ³
• Theochron ³
• Theo-Dur ³
• Theolair ³
• Theolair-SR ³
• Theo-Time ³
• Theovent Long-Acting ³
• Theo-X ³
• T-Phyl ³
• Truphylline ¹
• Truxophyllin ³
• Uni-Dur ³
• Uniphyl ³

In Canada?

• Apo-Oxtriphylline ²
• Apo-Theo LA ³
• Choledyl ²
• Choledyl SA ²
• Phyllocontin ¹
• Phyllocontin-350 ¹
• PMS Oxtriphylline ²
• PMS Theophylline ³
• Pulmophylline ³
• Quibron-T/SR Dividose ³
• Slo-Bid Gyrocaps ³
• Theochron ³
• Theo-Dur ³
• Theolair ³
• Theolair-SR ³
• Theo-SR ³
• Uniphyl ³

Category

• Bronchodilator?Aminophylline; Oxtriphylline; Theophylline
• Asthma prophylactic?Aminophylline; Oxtriphylline; Theophylline
• Stimulant, respiratory?Aminophylline Injection USP; Aminophylline Oral Solution USP; Theophylline Elixir; Theophylline OralSolution; Theophylline Syrup
• Antidote (to dipyridamole toxicity)?Aminophylline Injection USP

Description

Aminophylline, oxtriphylline,and theophylline are used to treat and/or prevent the symptoms of bronchialasthma, chronic bronchitis , and emphysema. These medicines relieve cough,wheezing, shortness of breath, and troubled breathing. They work by openingup the bronchial tubes (air passages of the lungs) and increasing the flowof air through them.

Aminophylline and theophylline may also be used for other conditions asdetermined by your doctor.

The oral liquid, tablet, and capsule dosage forms of these medicines maybe used for treatment of the acute attack or for chronic long-term treatment.The enteric-coated and extended-release dosage forms are usually used onlyfor chronic treatment. Sometimes, aminophylline suppositories may be usedbut they are generally not recommended because of possible poor absorption.

These medicines are available only with your doctor's prescription, inthe following dosage forms:

Oral
• Aminophylline
  • Oral solution (U.S.)
  • Tablets (U.S. and Canada)
  • Extended-release tablets (U.S. and Canada)
• Oxtriphylline
  • Oral solution (Canada)
  • Syrup (Canada)
  • Tablets (U.S. and Canada)
  • Delayed-release tablets (U.S.)
  • Extended-release tablets (U.S. and Canada)
• Theophylline
  • Capsules (U.S.)
  • Extended-release capsules (U.S. and Canada)
  • Elixir (U.S. and Canada)
  • Oral solution (U.S. and Canada)
  • Syrup (U.S.)
  • Tablets (U.S. and Canada)
  • Extended-release tablets (U.S. and Canada)

Parenteral
• Aminophylline
  • Injection (U.S. and Canada)
• Theophylline
  • Injection (U.S. and Canada)

Rectal
• Aminophylline
  • Suppositories (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 aminophylline, oxtriphylline,or theophylline, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to aminophylline, ethylenediamine (contained in aminophylline),oxtriphylline, or theophylline.

Diet?Make certain your health care professionalknows if you are on any special diet, such as a high-protein, low-carbohydrateor a low-protein, high-carbohydrate diet.

Pregnancy?Aminophylline, oxtriphylline, and theophylline arefrequently used to treat asthma in pregnant women. Although there are no studieson birth defects in humans, problems have not been reported. Some studiesin animals have shown that aminophylline, oxtriphylline, and theophyllinecan cause birth defects when given in doses many times the human 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 aminophylline, oxtriphylline,or theophylline during pregnancy may cause unwanted effects such as fast heartbeat,irritability, jitteriness, or vomiting in the newborn infant if the amountof medicine in your blood is too high.

Breast-feeding?Theophylline passes into the breast milk and maycause irritability in nursing babies of mothers taking aminophylline, oxtriphylline,or theophylline.

Children?Very young children and newborn infants require alower dose than older children. If the amount of theophylline in the bloodis too high, side effects are more likely to occur. Your doctor may want totake blood samples to determine whether a dose change is needed.

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 takeblood samples to determine whether a dose change is needed.

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 takingaminophylline, oxtriphylline, or theophylline, 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 aminophylline, oxtriphylline, or theophylline from workingproperly

• 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
• Propranolol (e.g., Inderal) or
• Tacrine (e.g., Cognex) or
• Thiabendazole or
• Ticlopidine (e.g., Ticlid) or
• Troleandomycin (e.g., TAO)?These medicines may increase theeffects of aminophylline, oxtriphylline, or theophylline

• Moricizine (e.g., Ethmozine) or
• Phenytoin (e.g., Dilantin) or
• Rifampin (e.g., Rifadin)?These medicines may decrease the effectsof aminophylline, oxtriphylline, or theophylline

• Smoking tobacco or marijuana?Starting or stopping smoking maychange the effectiveness of these medicines

Other medical problems?The presence of other medicalproblems may affect the use of aminophylline, oxtriphylline, or theophylline.Make sure you tell your doctor if you have any other medical problems, especially:

• Convulsions (seizures)?Aminophylline, oxtriphylline, or theophyllinemay make this condition worse

• Heart failure or
• Liver disease or
• Underactive thyroid?The effects of aminophylline, oxtriphylline,or theophylline may be increased

Proper Use of This Medicine

For patients taking this medicine by mouth:

• If you are taking the capsule, tablet, liquid,or extended-release (not including the once-a-day capsule or tablet) form of this medicine, it works best when taken witha glass of water on an empty stomach (either 30 minutes to 1 hour beforemeals or 2 hours after meals). In some cases your doctor may want you to takethis medicine with meals or right after meals to lessen stomach upset. Ifyou have any questions about how you should be taking this medicine, checkwith your doctor.
• If you are taking the once-a-day capsule ortablet form of this medicine, some products areto be taken each morning after fasting overnight and at least 1 hour beforeeating. However, other products are to be taken in the morning or eveningwith or without food. Be sure you understand exactly how to take the medicineprescribed for you. Try to take the medicine about the same time eachday.
• There are several different forms of aminophylline, oxtriphylline,and theophylline capsules and tablets. If you are taking:
  • Enteric-coated or delayed-release tablets,swallow the tablets whole. Do not crush, break, or chew before swallowing.
  • Extended-release capsules, swallow thecapsule whole. Do not crush, break, or chew before swallowing. Do not openthe capsule and sprinkle the beads onto food unless told to do so by yourhealth care professional.
  • Extended-release tablets, swallow thetablets whole. Do not break (unless tablet is scored for breaking), crush,or chew before swallowing.

Use this medicine only as directed by your doctor.Do not use more of it, do not use it more often, and do not use 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.

Dosing?When you are taking aminophylline, oxtriphylline,or theophylline, it is very important that you get the exact amount of medicinethat you need. The dose of these medicines will be different for differentpatients. Your doctor will determine the proper dose of these medicines foryou. Follow your doctor's orders or the directions onthe label.

After you begin taking aminophylline, oxtriphylline, or theophylline, itis very important that your doctor check the level of medicine in your bloodat regular intervals to find out if your dose needs to be changed. Do not change your dose of aminophylline, oxtriphylline, ortheophylline unless your doctor tells you to do so.

The number of capsules or tablets or teaspoonfuls of solution or syrupthat you take depends on the strength of the medicine. Also, the number of doses you take each day and the time between doses depend onwhether you are taking a short-acting or long-acting form of aminophylline,oxtriphylline, or theophylline.

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 or tablet form of this medicine in the bathroom,near the kitchen sink, or in other damp places. Heat or moisture may causethe medicine 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 using this medicine. Ablood test may be taken to help your doctor decide whether the dose of thismedicine should be changed.

Do not change brands or dosage forms of this medicinewithout first checking with your doctor. Different products may notwork the same way. If you refill your medicine and it looks different, checkwith your pharmacist.

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.

This medicine may add to the central nervous system (CNS) stimulant effectsof caffeine-containing foods or beverages such as chocolate, cocoa, tea, coffee,and cola drinks. Avoid eating or drinking large amounts of these foods orbeverages while using this medicine. If you have questions about this, checkwith your doctor.

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 sideeffects may occur, if they do occur they may need medical attention.

Check with your doctoras soon as possible if any of the following side effects occur:

Less common

Heartburn and/or vomiting

Rare

Hives, skin rash, or sloughing of skin (with aminophylline only)

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; nervousnessor 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 themedicine. However, check with your doctor if any of the following side effectscontinue or are bothersome:

Less common

Headache; fast heartbeat; 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.

Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although this use is not included in product labeling,aminophylline and theophylline are used in certain patients with the followingmedical condition:

• Apnea (breathing problem) in newborns

Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for this use.