Drug Details
Drug Name(s)\\tT-PHYL
FDA Application No.\\t(ANDA) 088253
Active Ingredient(s)\\tTHEOPHYLLINE
Company\\tPHARM RES ASSOC
Original Approval or Tentative Approval Date\\tAugust 17, 1983
Drug Name(s)\\tT-PHYL
FDA Application No.\\t(ANDA) 088253
Active Ingredient(s)\\tTHEOPHYLLINE
Company\\tPHARM RES ASSOC
Original Approval or Tentative Approval Date\\tAugust 17, 1983
Uses
This medication is used to treat and prevent wheezing and trouble breathing caused by ongoing lung disease (e.g., asthma, emphysema, chronic bronchitis). Theophylline belongs to a class of drugs known as xanthines. It works in the airways by relaxing muscles, opening air passages to improve breathing, and decreasing the lungs' response to irritants. Controlling symptoms of breathing problems can decrease time lost from work or school.This medication does not work right away and should not be used for sudden attacks of breathing trouble. Your doctor should prescribe a quick-relief medicine/inhaler (e.g., albuterol) for sudden attacks of shortness of breath/asthma while you are on this medication. You should always have a quick-relief inhaler with you. Consult your doctor or pharmacist for more details.
How to use T-Phyl
Take this medication by mouth with or without food, usually once or twice daily or as directed by your doctor. If this medication upsets your stomach, you may take it with food. This medicine works best when the amount in your body is kept at a constant level. Therefore, use this drug at evenly spaced intervals. Since different manufacturers have different recommendations, check with your doctor or pharmacist about the best time(s) to take your particular brand of theophylline.
Do not crush or chew this medication. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.
If you are taking the capsules, swallow them whole. If you are unable to swallow them, you may open the capsule and sprinkle the contents onto a spoonful of cool, soft food such as applesauce or pudding. Eat the entire mixture right away without chewing. Then drink a full glass of liquid (8 ounces or 240 milliliters). Do not prepare a supply for future use.
Dosage is based on your medical condition, response to treatment, age, weight, drug blood levels, and other drugs you may be taking. (See also Drug Interactions section.) Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.
Inform your doctor if your condition persists or worsens.
Side Effects
Stomach pain/cramping, nausea, vomiting, diarrhea, loss of appetite, headache, trouble sleeping, irritability, restlessness, nervousness, shaking, flushing, and increased urination may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if any of these unlikely but serious side effects occur: confusion, dizziness, mental/mood changes, muscle twitching/pain/tenderness, weakness, rapid breathing.Tell your doctor right away if any of these rare but very serious side effects occur: fainting, fast/slow/irregular heartbeat, vomit that looks like coffee grounds, dark/tarry stools, seizures.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, red/scaly skin, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Precautions
Before using theophylline, tell your doctor or pharmacist if you are allergic to it; or to aminophylline or oxtriphylline; or to theobromine or caffeine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain breathing disorder (cystic fibrosis), glaucoma, diabetes, heart problems (e.g., congestive heart failure, irregular heartbeat), high blood pressure, kidney disease, liver disease (e.g., cirrhosis), seizures, stomach/intestinal ulcer, thyroid disease.This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.If you develop a fever/flu-like symptoms while taking this medication, tell your doctor promptly. The dose of your medicine may need to be adjusted.Before having surgery, tell your doctor or dentist that you are using this medication.Older adults may be more sensitive to the side effects of this drug, especially fast/irregular heartbeat, or trouble sleeping. Careful monitoring of side effects and drug blood levels is recommended.Caution is advised when using this drug in children because they may be more sensitive to its effects. Careful monitoring of side effects, drug blood levels, and dose adjustment is recommended.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Changes in your body during the last 3 months of pregnancy may affect the amount of this drug in your blood. Your doctor should carefully monitor the amount of drug in your blood, as well as any side effects, so that your dose may be changed if needed.This drug passes into breast milk and may have undesirable effects on a nursing infant (e.g., irritability). Consult your doctor before breast-feeding.