Pronunciation:

thee-OF-i-lin

Brand Names:

• Norphyl
• Phyllocontin
• Choledyl Elixer
• Choledyl Pediatric

Dosage Forms:

• Tablet, Enteric Coated
• Elixir
• Tablet, Extended Release
• Tablet
• Syrup
• Solution

Uses of This Medicine:

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

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

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

These medicines are available only with your doctor's prescription.

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

• Apnea (breathing problem) in newborns

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

Before Using This Medicine:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children

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

Older adults

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

Pregnancy

Aminophylline, oxtriphylline, and theophylline are frequently used to treat asthma in pregnant women. Although there are no studies on birth defects in humans, problems have not been reported. Some studies in animals have shown that aminophylline, oxtriphylline, and 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 aminophylline, oxtriphylline, or theophylline 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.

Breast-feeding

Theophylline passes into the breast milk and may cause irritability in nursing babies of mothers taking aminophylline, oxtriphylline, or theophylline.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Convulsions (seizures) Aminophylline, oxtriphylline, or theophylline may 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 with a glass of water on an empty stomach (either 30 minutes to 1 hour before meals or 2 hours after meals). 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.
• If you are taking the once-a-day capsule or tablet form of this medicine, some products are to be taken each morning after fasting overnight and at least 1 hour before eating. However, other products are to be taken in the morning or evening with or without food. Be sure you understand exactly how to take the medicine prescribed for you. Try to take the medicine about the same time each day.
• 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 the capsule whole. Do not crush, break, or chew before swallowing. Do not open the capsule and sprinkle the beads onto food unless told to do so by your health care professional.
  • Extended-release tablets Swallow the tablets 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 longer time 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.

Dosing

The dose medicines in this class 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 these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

After you begin taking aminophylline, oxtriphylline, or theophylline, it is very important that your doctor check the level of medicine in your blood at regular intervals to find out if your dose needs to be changed.

Do not change your dose of aminophylline, oxtriphylline, or theophylline unless your doctor tells you to do so.

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

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

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. A blood test may be taken to help your doctor decide whether the dose of this medicine should be changed.

Do not change brands or dosage forms of this medicine without first checking with your doctor. Different products may not work the same way. If you refill your medicine and it looks different, check with your pharmacist.

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.

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 using this medicine. If you have questions about this, check with your doctor.

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.

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

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

nervousness or restlessness, continuing

trembling, continuing

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Headache

fast heartbeat

increased urination

nausea

nervousness

trembling

trouble in sleeping

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.