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Theophylline

Theophylline extended-release tablets are indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthm.

Checked against the official label · Updated

ز - الأدوية التي تصرف بموجب وصفة طبية Oral Safety alerts on record

How to use Theophylline

ما تقوله النشرة الرسمية. إذا وصفه لك طبيب، فاتبع الوصفة. وإذا اختلفت نشرة عبوتك، فالأولوية لها.

لمن هو

Theophylline extended-release tablets are indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.

كيف يُتناول وكم مرة
  • Taking theophylline extended-release tablets immediately after a high-fat content meal may result in a somewhat higher C max and delayed T max and somewhat greater extent of absorption
  • However, the differences are usually not great and this product may normally be administered without regard to meals (see CLINICAL PHARMACOLOGY, Drug interactions, Drug-Food Interactions )
  • Theophylline extended-release tablets are recommended for chronic or long-term management and prevention of symptoms, and not for use in treating acute symptoms of asthma and reversible bronchospasm
  • General considerations: The steady-state peak serum theophylline concentration is a function of the dose, the dosing interval, and the rate of theophylline absorption and clearance in the individual patient
  • Because of marked individual differences in the rate of theophylline clearance, the dose required to achieve a peak serum theophylline concentration in the 10-20 mcg/mL range varies fourfold among otherwise similar patients in the absence of factors known to alter theophylline clearance (e.g., 400- 1600 mg/day
  • In adults
Children
  • Theophylline is safe and effective for the approved indications
  • In pediatric patients
  • The maintenance dose of theophylline must be selected with caution
  • In pediatric patients since the rate of theophylline clearance is highly variable across the pediatric age range (see CLINICAL PHARMACOLOGY, Table I, WARNINGS, and DOSAGE AND ADMINISTRATION, Table V )
Older adults

Elderly patients are at a significantly greater risk of experiencing serious toxicity from theophylline than younger patients due to pharmacokinetic and pharmacodynamic changes associated with aging. The clearance of theophylline is described by an average of 30% in healthy elderly adults (>60 yrs) compared to healthy young adults. …

Talk to a doctor first if

Theophylline extended-release tablets are contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.

Medicines it may not mix with

Drug-Drug Interactions: Theophylline interacts with a wide variety of drugs. The interaction may be pharmacodynamic, i.e., alterations in the therapeutic response to theophylline or another drug or occurrence of adverse effects without a change in serum theophylline concentration. More frequently, however, the interaction is pharmacokinetic, i.e., the rate of theophylline clearance is altered by another drug resulting in increased or decreased serum theophylline concentrations. Theophylline only rarely alters the pharmacokinetics of other drugs. …

Warnings

Concurrent Illness: Theophylline should be used with extreme caution in patients with the following clinical conditions due to the increased risk of exacerbation of the concurrent condition: Active peptic ulcer disease Seizure disorders Cardiac arrhythmias (not including bradyarrhythmias) Conditions that Reduce Theophylline Clearance: There are several readily identifiable causes of reduced theophylline clearance. If the total daily dose is not appropriately reduced in the presence of these risk factors, severe and potentially fatal theophylline toxicity can occur. …

الآثار الجانبية المحتملة

Adverse reactions associated with theophylline are generally mild when peak serum theophylline concentrations are 300 mg/day in adults and >12 mg/kg/day in children beyond 1 year of age). During the initiation of theophylline therapy, caffeine-like adverse effects may transiently alter patient behavior, especially in school age children, but this response rarely persists. Initiation of theophylline therapy at a low dose with subsequent slow titration to a predetermined age-related maximum dose will significantly reduce the frequency of these transient adverse effects (see DOSAGE AND ADMINISTRATION, Table V ). In a small percentage of patients (

Pregnancy and breastfeeding

Pregnancy: Teratogenic Effects: In studies in which pregnant mice, rats and rabbits were dosed during the period of organogenesis, theophylline produced teratogenic effects. In studies with mice, a single intraperitoneal dose at and above 100 mg/kg (approximately equal to the maximum recommended oral dose for adults on a mg/m 2 basis) during organogenesis produced cleft palate and digital abnormalities. …

If you take too much

General: The chronicity and pattern of theophylline overdosage significantly influences clinical manifestations of toxicity, management and outcome. There are two common presentations: (1) acute overdose , i.e., ingestion of a single large excessive dose (>10 mg/kg) as occurs in the context of an attempted suicide or isolated medication error, and (2) chronic overdosage , i.e., ingestion of repeated doses that are excessive for the patient's rate of theophylline clearance. …

إذا نسيت جرعة

تناولها عندما تتذكر، إلا إذا اقترب موعد الجرعة التالية. عندها تخطَّ الجرعة المنسية. لا تتناول جرعتين معًا أبدًا للتعويض. راجع النشرة، فبعض الأدوية مختلفة.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2024-04-27.

الأسماء التجارية حول العالم

Products with Theophylline as the active ingredient. Names differ between countries.

Registered products

United States (FDA)

TheophyllineTHEOPHYLLINE ANHYDROUS 600 mg/1 · Tablet, Extended Release · Glenmark Pharmaceuticals Inc., USA
NDC 68462-356Label
TheophyllineTHEOPHYLLINE ANHYDROUS 300 mg/1 · Tablet, Extended Release · Zydus Lifesciences Limited
NDC 70771-1782Label
TheophyllineTHEOPHYLLINE ANHYDROUS 450 mg/1 · Tablet, Extended Release · Zydus Lifesciences Limited
NDC 70771-1783Label
TheophyllineTHEOPHYLLINE ANHYDROUS 300 mg/1 · Tablet, Extended Release · Viona Pharmaceuticals Inc
NDC 72578-173Label
TheophyllineTHEOPHYLLINE ANHYDROUS 450 mg/1 · Tablet, Extended Release · Viona Pharmaceuticals Inc
NDC 72578-174Label

Nigeria (NAFDAC)

NAFDACShreenol-F A4-0900NAFDACAsdrex Tablet 04-7895NAFDACJeonol Tablets 04-7985NAFDACFralif Tablets B4-2202NAFDACPelinol Tablet A4-2840NAFDACPhinol Tablets B4-4767NAFDACTheo-Ventokris A11-100204NAFDACAsmanol Tablet_ A4-5674NAFDACKoyonol Tablets A4-8870NAFDACLifenol Tablets A4-1028NAFDACAiromol Tablets B4-3125NAFDACCikanol Tablets A11-100228

Other countries: check your pack's registration number and we point you to your regulator.

Safety alerts and recalls

Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: GlenU.S. FDA Class II
8 Aug 2025 · Glenmark Pharmaceuticals Inc., USA · OngoingFailed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution cr
Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, India. U.S. FDA Class II
15 May 2025 · Glenmark Pharmaceuticals Inc., USA · OngoingOOS results reported for the Dissolution (by UV) test.
Theophylline (Anhydrous) Extended-Release Tablets 400 mg 100 Tablets Rx Only NDC 68462-380-01 Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India MaU.S. FDA Class II
15 Mar 2021 · Cardinal Health Inc. · TerminatedCGMP Deviations: Intermittent exposure to temperature excursion during storage.
Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC 29033-001-01.U.S. FDA Class II
6 Mar 2020 · Nostrum Laboratories Inc · TerminatedCGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.

A recall usually affects certain batches only. Compare the lot number on your pack.

Check your pack of Theophylline

Type the registration number on the pack, or scan it with your camera.

أو التقط صورًا للعبوة
تبقّت 3 عمليات تحقق مجانية اليوم Official sources: U.S. FDA · EMA (EU) · Health Canada · WHO alerts

Questions about Theophylline

What is Theophylline used for?

Theophylline extended-release tablets are indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis. (From the official U.S. FDA label.)

How do I take Theophylline?

Follow your prescription or the leaflet in your pack. The official label says: Taking theophylline extended-release tablets immediately after a high-fat content meal may result in a somewhat higher C max and delayed T max and somewhat greater extent of absorption. However, the differences are usually not great and this product may normally be administered without regard to meals (see CLINICAL PHARMACOLOGY, Drug interactions, Drug-Food Interactions ). Theo…

Do I need a prescription for Theophylline?

Usually yes. Theophylline is a prescription medicine in most countries. Rules differ by country.

What brands contain Theophylline?

Theophylline is sold under names such as Theo-24, Elixophyllin. Brand names differ between countries.

What are the side effects of Theophylline?

The official label lists: Adverse reactions associated with theophylline are generally mild when peak serum theophylline concentrations are 300 mg/day in adults and >12 mg/kg/day in children beyond 1 year of age). During the initiation of theophylline therapy, caffeine-like adverse effects may transiently alter patient behavior, especially in school age children, but this response rarely persists. Initi… Tell your doctor about any side effect that bothers you or does not go away.

Can children take Theophylline?

Theophylline is safe and effective for the approved indications in pediatric patients. The maintenance dose of theophylline must be selected with caution in pediatric patients since the rate of theophylline clearance is highly variable across the pediatric age range (see CLINICAL PHARMACOLOGY, Table I, WARNINGS, and DOSAGE AND ADMINISTRATION, Table V ). Always use the dose for the child's age or weight on the pack or prescription.

Can I take Theophylline when pregnant or breastfeeding?

Pregnancy: Teratogenic Effects: In studies in which pregnant mice, rats and rabbits were dosed during the period of organogenesis, theophylline produced teratogenic effects. In studies with mice, a single intraperitoneal dose at and above 100 mg/kg (approximately equal to the maximum recommended oral dose for adults on a mg/m 2 basis) during organogenesis produced cleft palate… Ask your doctor or midwife first.

What medicines interact with Theophylline?

Drug-Drug Interactions: Theophylline interacts with a wide variety of drugs. The interaction may be pharmacodynamic, i.e., alterations in the therapeutic response to theophylline or another drug or occurrence of adverse effects without a change in serum theophylline concentration. More frequently, however, the interaction is pharmacokinetic, i.e., the rate of theophylline clear… Use the free interaction checker before combining medicines.

What happens if I take too much Theophylline?

General: The chronicity and pattern of theophylline overdosage significantly influences clinical manifestations of toxicity, management and outcome. There are two common presentations: (1) acute overdose , i.e., ingestion of a single large excessive dose (>10 mg/kg) as occurs in the context of an at… Get medical help right away.

How can I check that my Theophylline is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.

Sources

This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.