API

Theophylline (600mg)

Drug classification

Methylxanthine derivative; bronchodilator.

Dosage form

Extended-release tablet containing 600 mg theophylline.

API strength per dosage

Dose

Unicontin-E 600 Tablet CR (theophylline 600mg) dosing is individualized based on age, weight, and serum theophylline levels. Adults typically start with lower doses, titrated to response. Children require weight-based dosing. Use caution and consider dose reduction in elderly, hepatic impairment, or heart failure. Monitor serum levels to avoid toxicity. Not recommended in severe renal or hepatic impairment.

Mechanism of action

Theophylline inhibits phosphodiesterase (mainly PDE III and IV), increasing intracellular cyclic AMP. This leads to bronchodilation by relaxing bronchial smooth muscle. It also antagonizes adenosine receptors, reducing bronchoconstriction and histamine release. The net physiological result is improved airflow and reduced airway reactivity in obstructive pulmonary diseases.

Indications

Treatment of Chronic obstructive pulmonary disease (COPD)

Side effects

Vomiting Headache Nausea Upset stomach

Pregnancy category

Theophylline should be used during pregnancy only if clearly needed; potential benefits must be weighed against possible fetal risks. Monitor maternal serum levels closely.

Precautions

Monitor serum theophylline levels, assess for signs of toxicity, use caution in hepatic or cardiac impairment, monitor for drug interactions, adjust dose in elderly or smokers, avoid abrupt discontinuation, monitor for gastrointestinal upset, seizures, arrhythmias, and ensure patient hydration.

Contraindications

Hypersensitivity to theophylline or xanthine derivatives, active peptic ulcer, uncontrolled arrhythmias, recent myocardial infarction, seizure disorders, hyperthyroidism, porphyria, uncontrolled hypertension.