BEXIMCO PHARMACEUTICALS LTD.
Salbutamol is indicated as a bronchodilator for use in Asthma, Chronic Bronchitis, Emphysema and other conditions associated with airways obstruction.
Short-acting selective & 82-adrenoceptor stimulants
Salbutamol is a selective beta2-adrenoceptor agonist. At therapeutic doses, it acts on the beta 2-adrenoceptors of bronchial smooth muscle, with little or no action on the 81-adrenoceptors of cardiac muscle. Salbutamol provides short acting (4-6 hours) bronchodilatation with a fast onset (within 5 minutes) in reversible airways obstruction. It also has an anti-inflammatory effect on mast cells causing inhibition of release of bronchoconstrictor mediators including histamine, neutrophil chemotactive factor (NCF) and prostaglandin D2.
Oral- Children: 2-6 years: 2.5 ml syrup, 3-4 times daily 6-12 years: 5 ml syrup, 3-4 times daily Over 12 years: 5-10 ml syrup, 3-4 times daily (2-4 mg tablet, 3-4 times daily) Adults: 2-4 mg tablet, 3-4 times daily. Maximum single dose is 8 mg tablet. Injection- salbutamol Injection may be administered by the subcutaneous, intramuscular or intravenous route, under the direction of a physician. Adults: Subcutaneous route: 500 mcg (8 mcg/kg) and repeated every four hours as required. Intramuscular route: 500 mcg (8 mcg/kg) and repeated every four hours as required. Slow intravenous injection: 250 mcg (4 mcg/kg) injected slowly. If necessary the dose may be repeated. The use of salbutamol Injection 500 mcg in 1 ml (500 mcg/ml, for intravenenous administration may be facilitated by dilution to 10 ml with Water for Injection BP (final concentration of 50 mcg/ml) and 5 ml of the diluted preparation (250 mcg/5 ml) administered by slow intravenous injection. Pediatric Population: The safety and efficacy of salbutamol Injection in children under the age of 12 has not been established. From the available data no recommendation on posology can be made. Children aged 12 years and over: Dose as per adult population
Salbutamol is contraindicated in patients with a history of hypersensitivity to Salbutamol or any of its components.
Salbutamol may cause fine tremor of skeletal muscles (particularly the hands), palpitations and muscle cramps. Tachycardia, tenseness, headaches and peripheral vasodilatation have been reported after large doses.
Pregnancy: The drug should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. Lactation: It is not known whether this drug is excreted in human milk. Because of the potential of tumorigenecity shown for Salbutamol in some animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
The symptoms with overdosage are angina, headache, nausea, vomiting, tremor etc. The preferred antidote for overdosage with Salbutamol is a cardio-selective beta-blocking agent but beta-blocking drugs should be used with caution in patients with a history of bronchospasm.
Salbutamol should be used with caution in patients with hyperthyroidism, cardiovascular disease, occlusive vascular disorders, hypertension and aneurysms. Hypokalaemia associated with high doses of Salbutamol may result in increased susceptibility to digitalis-induced cardiac arrhythmia. Tachyphylaxis with resistance may occur with prolonged use of high dosage. Care is necessary when treating patients with diabetes mellitus or closed-angle glaucoma, and in those receiving antihypertensive therapy.
Should be stored in cool and dry place