Uniphyl

DRUG DESCRIPTION

Uniphyl (theophylline anhydrous tablet) ® (theophylline, anhydrous) Tablets in a controlled-release system allows a 24-hour dosing interval for appropriate patients.

Theophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste.

Anhydrous theophylline has the chemical name 1H-Purine-2,6-dione, 3,7-dihydro-1,3-dimethyl-, and is represented by the following structural formula:

 Uniphyl® (theophylline, anhydrous)  Structural Formula Illustration

The molecular formula of anhydrous theophylline is C7H8N4O2 with a molecular weight of 180.17.

Each controlled-release tablet for oral administration, contains 400 or 600 mg of anhydrous theophylline.

Inactive Ingredients: cetostearyl alcohol, hydroxyethyl cellulose, magnesium stearate, povidone and talc.

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...

Read All Potential Side Effects and See Pictures of Uniphyl »

What are the precautions when taking theophylline anhydrous tablet (Uniphyl)?

Before using theophylline, tell your doctor or pharmacist if you are allergic to it; 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...

Read All Potential Precautions of Uniphyl »


Uniphyl Consumer (continued)

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 immediately 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 immediately 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.

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 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.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects. 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.


Uniphyl Patient Information Including Side Effects

Brand Names: Elixophyllin, Theo-24, TheoCap, Theochron, Theo-Time, Uniphyl

Generic Name: theophylline (Pronunciation: thee OFF i lin)

  • What is theophylline (Uniphyl)?
  • What are the possible side effects of theophylline?
  • What is the most important information I should know about theophylline?
  • What should I discuss with my healthcare provider before taking theophylline?
  • How should I take theophylline?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while taking theophylline?
  • What other drugs will affect theophylline?
  • Where can I get more information?

What is theophylline (Uniphyl)?

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.

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

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.

Avoid drinks or foods that contain caffeine, such as coffee, tea, cola, and chocolate. Caffeine may increase some of the side effects of theophylline.

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.

Related Drug Centers
  • Theo-24
  • Uniphyl


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