THEOPHYLLINE (LONG ACTING)

Dosage form Tablets, 100 mg
Tablets, 200 mg

Uses Theophylline is used mainly for the relief of bronchospasm in asthma. It has a narrow therapeutic range and serum-theophylline concentrations should be monitored during therapy. Adverse effects commonly affect the gastro-intestinal tract and CNS. Following overdosage tremor, delirum, tachycardia, convulsions, and death may occur.

Administration In the treatment or prevention of chronic bronchospasm: In the US the following Theophylline oral doses are suggested: adults and children over 1 year of age 16 mg per kg body-weight daily or 400 mg daily, whichever is the smaller, in divided doses where appropriate. If tolerated, the dose should then be increased in increments of approximately 25% at 2 to 3-day intervals until the following maximum daily doses are reached, which are the highest recommended without serum-theophylline concentration measurement; children ages 1 to 9 years 24 mg per kg body-weight; children aged 9 to 12 years 20 mg per kg; children aged 12 to 16 years 18 mg per kg; patients aged 16 years and above 13 mg per kg or 900 mg, whichever is the smaller. If toxicity is experienced at these doses, or higher doses are to be given, serum-theophylline concentration should be measured and final dosage adjustments based upon the results and the patient's clinical state.

Observe
The side-effects: Commonly encountered with Theophylline and its derivatives irrespective of the route of administration, are gastro-intestinal irritation and stimulation of the central nervous system. Theophylline may cause nausea, vomiting, abdominal pain. diarrhoea, gastro-intestinal bleeding, insomnia, headache, anxiety, restlessness, dizziness, and palpitations. Severe overdosage or idiosyncrasy may also lead to maniacal behavior, diuresis and repeated vomiting with extreme thirst, tremor, delirium, hyperthermia, tachycardia, tachypnoea, electrolyte disturbances, convulsions, and death. Severe toxicity may not be preceded by milder symptoms. Hypotension may follow intravenous injection, particularly if the injection is too rapid, and sudden deaths have been reported. Proctitis may follow repeated administration of suppositories and intramuscular injections are painful, the pain lasting several hours.
Plasma concentrations of Theophylline greater than 20 µg per ml are considered to be toxic.

Storage Store in a cool and dry place in airtight container, away from light. Keep out of reach of children.