International generic name

Salbutamol

Drug form and composition

Syrup. Five milliliters syrup contains 2.41 mg Salbutamol sulfate equivalent to 2 mg Salbutamol.

Indications

Salbutamol is used in cases of bronchospasm in patients with reversible airway obstruction: mild and moderate attacks of dyspnea in patients suffering from bronchial asthma; mild and moderate bronchoobstruction in patients with chronic bronchitis and lung emphysema.

Dosage and administration

Adults and children over 12 years: The recommended dose is 2 - 4 mg (5 - 10 ml syrup) 3 - 4 times daily. The maximal daily dose should not exceed 32 mg (divided in 3 or 4 doses). Children: between 2 and 6 years, the dose is 0.1 - 0.2 mg/kg body weight given 3 times daily. The maximal daily dose must not exceed 4 mg, 3 times daily, and the daily dose for 6 - 12 years-old children is to 24 mg daily, divided in 3 or 4 doses.

Contraindications

Hypersensitivity to some of the drug ingredients.

Special warnings and precautions

The drug should be used with caution in patients with heart diseases and probable rhythm disorders (advanced high grade valvular diseases, ischemic heart disease, cardiomyopathy, etc.), as well as in patients with diabetes mellitus. The safety, efficacy, and dosage of the drug in bellow 2 year-old children have not been established. The drug should be avoided during pregnancy, particularly during the first trimester and during labor, because it is established that the high doses can suppress the contractions of the uterus. There are no data for risks related with the administration of the drug in breast-feeding women. Because of the possibility for induction of tremor, dizziness, and weakness, the drug should be used cautiously in drivers and people working with machines.

Drug interactions

In cases of concurrent administration with MAO-inhibitors or antidepressants, a potentiation of the cardiovascular effects is observed. The β-blockers antagonize the action of Salbutamol. In cases of simultaneous administration with digitalis glycosides, theophylline, oral antidiabetic agents, insulin, sympathomimetics, Salbutamol can increase the toxicity of these agents.

Adverse reactions

Headache; tremor; tachycardia; hypertension; anxiety. Rarely nausea, vomiting, and skin rash can be observed.

Pharmacological mechanisms

Salbutamol is a selective 2-adrenomimetic agent stimulating mainly the 2-adrenergic receptors and to a lesser extent 1-adrenergic receptors in the myocardium. The stimulation of the 2 receptors leads to adenylate cyclase activation and cAMP accumulation, alterations in the methyl transferase activity, decrease in the calcium ion intracellular concentration. Due to these changes bronchial smooth muscle relaxation and inhibition of mast cell degranulation develop. The antiasthmatic action of Salbutamol is related to the decrease of edema and mucus secretion. The drug has no influence on the heart activity, and there are no tachycardia and blood pressure elevation.

Supplied

Vial, containing 125 ml syrup.

Expiry

2 years.