Theophylline Extended Release Tablet

SECTION 2: Hazards identification

Taking theophylline extended-release tablets immediately after a high-fat content meal may result in a somewhat higher Cmax and delayed Tmax and somewhat greater extent of absorption. However, the differences are usually not great and this product may normally be administered without regard to meals. Dose and Administration 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. Adverse reactions associated with theophylline are generally mild when peak serum theophylline concentrations are < 20 mcg/mL and mainly consist of transient caffeine-like adverse effects such as nausea, vomiting, headache and insomnia. When peak serum theophylline concentrations exceed 20 mcg/mL, however, theophylline produces a wide range of adverse reactions including persistent vomiting, cardiac arrhythmias and intractable seizures which can be lethal. The transient caffeine-like adverse reactions occur in about 50% of Adverse Effects patients when theophylline therapy is initiated at doses higher than recommended initial doses (e.g.,> 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. 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. The most Overdosage common causes of chronic theophylline overdosage include patient or care giver error in dosing, healthcare professional prescribing of an excessive dose or a normal dose in the presence of factors known to decrease the rate of theophylline clearance and increasing the dose in response to an exacerbation of symptoms without first measuring the serum theophylline concentration to determine whether a dose increase is safe. There are no adequate and well-controlled studies in pregnant Pregnancy Comments women. Theophylline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Pregnancy Category Category C