Presentation

Arofil 200 SR: Each film coated tablet contains Theophylline BP 200 mg in a sustained release formulation.

Arofil 300 SR: Each film coated tablet contains Theophylline BP 300 mg in a sustained release formulation.

Arofil 400 SR: Each film coated tablet contains Theophylline BP 400 mg in a sustained release formulation.

Description

Theophylline is a Xanthine derivative bronchodilator; it directly relaxes the smooth muscle of the bronchial airways and smooth pulmonary blood vessels, thus acting mainly as a bronchodilator and smooth muscle relaxant.

Indications

1) Control of acute asthma

2) Management of chronic asthma (For both Symptomatic and prophylactic treatment)

3) For controlling nocturnal asthma and early morning wheezing

4) Management of chronic obstructive lung disease (Chronic bronchitis and emphysema) and acute exacerbation of chronic obstructive lung disease

5) Control of apnea of pre-maturity

Dosage & Administration

Usually Arofil SR tablet 12 hourly or as directed by the physicians.

Age Dose/day in bid

1-9 years 24 mg/kg

9-12 years 20 mg/kg

12-16 years 18 mg/kg

Over 16 years 13 mg/kg or 900 mg

Side Effects

These usually occur when Theophylline blood levels exceed 20 mgm/ml and include gastric irritation, nausea, vomiting, abdominal discomfort and palpitations, a fall in blood pressure, headache, occasional diarrhoea and insomnia. CNS stimulation and diuresis may also occur, especially in children.

Precautions

Smoking and alcohol consumption can increase the clearance of Theophylline and a higher dosage may be necessary.

Careful monitoring is recommended for patients with congestive heart failure, chronic alcoholism, hepatic dysfunction or viral infections as they may have lower total clearance of Theophylline which could lead to higher than normal plasma levels.

Caution should be exercised in patients with hyperthyroidism, cardiac arrhythmia, hypertension or other cardiovascular diseases.

Use in Pregnancy & Lactation

Safety in human pregnancy has not been established. Theophylline crosses the placental barrier & is secreted in breast milk. Theophylline should be used with caution in pregnancy & lactation.

Over Dose

Symptoms may include nausea, vomiting, gastrointestinal irritation, cramps, convulsions, tachycardia & hypotension. The stomach contents should be emptied & supportive measures employed to maintain circulation, respiration & fluid & electrolyte balance. Electrocardiographic monitoring should be carried out & in severe poisoning charcoal haemoperfusion should be used.

Commercial Pack

Arofil 200 SR: Each box contains 10 blister strips of 10 sustained release tablets.

Arofil 300 SR: Each box contains 5 blister strips of 10 sustained release tablets.

Arofil 400 SR: Each box contains 5 blister strips of 10 sustained release tablets.