International generic name
Drug form and composition
Syrup. Five milliliters syrup contains 2.41 mg Salbutamol sulfate equivalent
to 2 mg Salbutamol.
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.
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.
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.
Headache; tremor; tachycardia; hypertension; anxiety. Rarely nausea, vomiting,
and skin rash can be observed.
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.
Vial, containing 125 ml syrup.