Arolax® 1: Each tablet contains Levosalbutamol Sulphate INN equivalent to 1 mg Levosalbutamol. Arolax® Syrup (60 ml and 100 ml) : Each 5 ml strawberry flavoured syrup contains Levosalbutamol Sulphate INN equivalent to 1 mg Levosalbutamol.
Levosalbutamol is the R-isomer of racemic Salbutamol having b2 agonist activity. Levosalbutamol is an effective bronchodilator whose primary mechanism of action is not inhibited by S-Salbutamol. Thus, when compared with racemic Salbutamol, clinically comparable bronchodilation can be achieved with doses that substantially lessen b-mediated side effects.
Levosalbutamol is indicated for the relief of bronchospasm in conditions such as asthma and COPD in adults, adolescents, and children 6 years of age and older.
Dosage and Administration : Adults and adolescents above 12 years: 5-10 ml (1-2 mg) three times daily. Children (6-11 years): 5 ml (1 mg) three times daily.
Levosalbutamol is contraindicated in patients with a history of hypersensitivity to this compound or any of the components of this formulation.
Potentially serious hypokalaemia may result from b2 agonist therapy. Particular caution is advised in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment with xanthine derivatives, steroids and diuretics. Serum potassium levels should be monitored in such situations. Levosalbutamol, like all other b2 adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure and/or symptoms. Although such effects are uncommon after administration of Levosalbutamol at recommended doses.
Use in Pregnancy and Lactation :
Use of oral Levosalbutamol in pregnant women should be considered only if the expected benefit to the mother is greater than any possible risk to the fetus or the infant. It is not known whether Levosalbutamol is excreted in human milk. Caution should be exercised when oral Levosalbutamol is administered to a nursing woman.
Side Effects :
Potentially serious hypokalaemia may result from b2 agonist therapy. This effect may be potentiated by hypoxia. Particular caution is advised in severe asthma, with monitoring of serum potassium levels. Other side effects such as palpitation, fine tremors of the skeletal muscle (particularly the hand) and muscle cramps may occur. The other likely side effects are gastrointestinal disturbances such as nausea, vomiting, burning substernal or epigastric pain and diarrhoea. In some cases nervousness, headache, dizziness, fatigue and sleeplessness may occur.
The expected symptoms with overdosage are those of excessive b-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under side effects e.g., tachycardia, nervousness, headache, tremor, nausea, dizziness, fatigue and sleeplessness. Hypokalaemia also may occur. Treatment consists of discontinuation of oral Levosalbutamol together with appropriate symptomatic therapy. In the event of serious poisoning, the stomach should be emptied and, if necessary, a b-blocker administered with caution in patients with a history of bronchospasm.
Storage Condition :
Store in a cool dry place protected from light. Keep out of the reach of children.
Commercial Pack :
Arolax® 1: Each box contains 10 x 10's tablet in blister pack.
Arolax® Syrup (100 ml) : Each box contains 100 ml Bottle of syrup.
Arolax® Syrup (60 ml) : Each box contains 60 ml Bottle of syrup.