Theophyl - 12 Tablets “Anhydrous Theophylline”


Composition:-
Each tablet contains:
Anhydrous theophylline       200 mg

Pharmacological properties:
Theophylline has two distinct actions in the airways of patients with reversible obstruction, these are smooth muscle relaxation (bronchodilatation) and suppression of the response of the airways to stimuli. The mechanism of action of thyeophylline may be mediated by inhibition of phosphodiesterase activity.
Theophylline increases the force of contraction of diaphragmatic muscles due to enhancement of calcium uptake through an adenosine–mediated channel.

Pharmacokinetics:
Theophylline is rapidly absorbed after oral administration. After a single dose of theophylline (5 mg/kg) in adults, a mean peak serum concentration of about 10 mcg/ml can be expected 1-2 hours after the administered dose.
In adults and children beyond 1 year of age, approximately 90% of the dose is metabolized in the liver.

Indications:
Theophyl – 12 tablets are indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases such as emphysema and chronic bronchitis.

Contraindications:
Theophyl – 12 is contraindicted in patients with a history of hypersensitivity to theophylline or other components in the product.

Side Effects:
Nausea, vomiting, headache, insomnia, muscle spasm and cardiac arrhythmias may occur.

Drug interactions:
Allopurinol – Cimetidine – Ciprofloxacin – erythromycin – Norfloxacin and Propranolol inhibit the metabolism of theophylline.

Pregnancy:
There are no adequate and well-controlled studies in pregnant women.

Nursing Mothers:
Theophylline is excreted into breast milk and may cause irritability in nursing human infants.

Dosage and Administration:
•    Children (6-15 years ), <45 kg:
•    12-14 mg/kg/day up to a maximum of 300 mg/day in two divided doses every 12 hours.
•    After 3 days, if tolerated increase dose to 16 mg/kg/day up to a maximum of 400 mg/day in two divided doses every 12 hours.
•    After 3 more days, if tolerated, increase dose to 20 mg/kg/day up to a maximum of 600 mg/day divided every 12 hours.
•    Children (6-15 years), >45 kg; and adults: 300 mg/day twice daily.
•    After 3 days, 300 mg/day, if tolerated, increase dose to 400 mg/day twice daily.
•    After 3 more days, if tolerated, increase dose to 600 mg/day twice daily.

Package:
Boxes each containing 20 tablets.