Aminophylline Injection 250 mg / 10mL Bronchodilator Medicines BP / USP

AMINOPHYLLIN 250 mg/10 mL INJECTION

COMPOSITION:

AMINOPHYLLIN 250 mg/10 mL INJECTION contains 250 mg aminophylline dihydrate in 10 mL.

PHARMACOLOGICAL ACTION:

Aminophylline is a soluble complex containing approximately 85% theophylline and 15% ethylenediamine. Aminophylline directly relaxes the smooth muscle of the bronchial airways and pulmonary blood vessels, thus acting mainly as a bronchodilator, pulmonary vasodilator and smooth muscle relaxant.

INDICATIONS:

AMINOPHYLLIN is indicated for relief of acute bronchial asthma and reversible bronchospasm associated with chronic bronchitis and emphysema, and in status asthmaticus; congestive heart failure; Cheyne-Stokes respiration; reduction of coughing, expectoration and exertional dyspnoea in emphysema patients, and for cardiac paroxysmal dyspnoea.

CONTRA-INDICATIONS:

AMINOPHYLLIN should not be given to patients with active peptic ulcers, since it may increase the volume and acidity of gastric secretions. Patients with a history of hypersensitivity to aminophylline or theophylline should not be treated with AMINOPHYLLIN. Do not administer AMINOPHYLLIN with other xanthine preparations. Safe use of AMINOPHYLLIN in pregnancy has not been established.

DOSAGE AND DIRECTIONS FOR USE:

250 mg/10 mL (Intravenous):
For intravenous administration, AMINOPHYLLIN is supplied in ampoules of 10 mL (250 mg) in aqueous solution.
Adults: 250 mg or 500 mg as required.
Children: The dose is proportionally smaller and is based upon the child’s age and body weight.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:

The most consistent adverse reactions observed with therapeutic amounts of aminophylline are:

STORAGE INSTRUCTIONS:

Store in a cool dry place (below 25°C) away from light.
Keep out of reach of children.