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What is theophylline?
Theophylline is a bronchodilator. It works by relaxing muscles in the lungs and chest, and makes the lungs less sensitive to allergens and other causes of bronchospasm. Theophylline is used to treat the symptoms of asthma, bronchitis and emphysema. Theophylline may also be used for other purposes not listed in this medication guide.

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What are the possible side effects of theophylline?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using theophylline and call your doctor at once if you have any of these serious side effects:

• seizure (convulsions);

• worsening of your condition, or symptoms of new illness;

• severe or ongoing nausea and vomiting, headache, fast or uneven heart rate, and trouble sleeping (insomnia);

• coughing up blood or vomit that looks like coffee grounds;

• ongoing fever;

• feeling restless, irritable, nervous, or jittery.

• tremors; or

• urinating more than usual.

Less serious side effects may include:

• mild nausea, loss of appetite, weight loss;

• restlessness, tremor, or insomnia; or

• headache, lightheadedness, or dizziness.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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How should I take theophylline?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results from this medication. Take this medicine with a full glass of water. You may take theophylline with or without food, but take it the same way every time. Do not crush, chew, break, or open an extended-release tablet or capsule unless your doctor tells you to. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

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What is the most important information I should know about theophylline?
If there are any changes in the brand, strength, or type of theophylline you use, your dosage needs may change. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy. Do not start or stop smoking without first talking to your doctor. Smoking changes the way your body uses theophylline, and you may need to use a different dose.

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What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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What other drugs will affect theophylline?
Before taking theophylline, tell your doctor if you are using any of the following drugs: carbamazepine (Carbatrol, Tegretol); cimetidine (Tagamet); enoxacin (Penetrx); ephedrine or similar medications found in cold medicine or diet pills; erythromycin (E.E.S., E-Mycin, Ery-Tab); fluvoxamine (Luvox); propranolol (Inderal, InnoPran); rifampin (Rifadin, Rifater, Rifamate, Rimactane); St. John's wort; or thiabendazole (Mintezol). This list is not complete and there are many other medicines that can interact with theophylline. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Theophylline has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryolethality and teratogenicity. There are no controlled data in human pregnancy. Theophylline is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

The Collaborative Perinatal Project monitored 193 women with first trimester exposure to theophylline or aminophylline and found no increased risk of malformations. Cord serum concentrations and infant serum concentrations have been reported to approximate the mother's serum concentrations immediately following birth. In 12 mothers receiving theophylline, at the time of delivery, maternal serum, cord serum, and infant serum theophylline concentrations averaged 10 mcg/mL. Cases of jitteriness, irritability, and vomiting have been reported in infants of mothers maintained on theophylline prior to delivery. Apnea has been reported in an infant born after 37.5 weeks gestation to a mother who had been maintained on theophylline throughout pregnancy for asthma. At approximately 48 hours after birth, the infants serum theophylline level was 15 mcg/mL. The infant was placed on theophylline when the concentration measured 2 mcg/mL. Apnea resolved when the theophylline concentration reached 17 mcg/mL. The pharmacokinetics of theophylline have been studied in women during pregnancy. Studies throughout pregnancy have noted a significant decrease in the clearance of theophylline during the third trimester. The clearance was only slightly decreased during the first and second trimester. The plasma protein binding of theophylline also has been shown to decrease in the later stages of pregnancy. It is important to closely monitor the theophylline serum concentration and the patient for signs of toxicity during pregnancy. One study has shown an increase in fetal breathing movements when theophylline was ingested by pregnant women at 33 to 38 weeks gestation. Since fetal breathing movements are routinely used to assess fetal status in late gestation, maternal theophylline intake should be taken into account.

Theophylline is excreted into human milk and may cause irritability or other signs of mild toxicity. The concentration of theophylline in breast milk is approximately equivalent to the maternal serum concentration. The manufacturer states that serious adverse effects in the infant are unlikely unless the mother has toxic serum theophylline concentrations. The American Academy of Pediatrics considers theophylline to be compatible with breast-feeding.

In a study of five women given aminophylline, theophylline was detected in milk with a milk:serum ratio of 0.61 to 0.87. The peak milk concentration occurred between one and three hours after ingestion of the dose. Irritability was reported in one infant whose mother took aminophylline. Adverse effects were not reported in the infants of the other women participating in this study. Exposure to the infant can be minimized by administering nursing prior to administration of theophylline to avoid peak milk concentrations.

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, insomnia, tremors, restlessness, uneven heartbeats, and seizure (convulsions). Seizures caused by a theophylline overdose can cause death or permanent brain damage.

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What should I discuss with my healthcare provider before taking theophylline?
Do not use this medication if you are allergic to theophylline. Before taking theophylline, tell your doctor if you are allergic to any drugs, or if you have: a stomach ulcer; epilepsy or other seizure disorder; a heart rhythm problem; congestive heart failure; fluid in your lungs; underactive thyroid; a high fever; liver disease (such as cirrhosis or hepatitis); kidney disease; or if you have recently quit smoking cigarettes or marijuana. If you have any of these conditions, you may need a dose adjustment or special tests to safely take theophylline.

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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