INDICATIONS: Montelukast is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patient 6 years of age and older.

DOSAGE AND ADMINISTRATION: Adults: The dosage for adolescents and adults 15 years of age and older is 10 mg tablet daily to be taken in the evening. Children: The dosage for pediatric patients 6 - 14 years of age is 5 mg tablet daily to be taken in the evening. No dosage adjustment within this age group is necessary. Safety and effectiveness in paediatric patients younger than 6 years of age have not been established. CONTRAINDICATION AND PRECAUTION: Contraindication of Montelukast includes hypersensitivity to any component of this product. Montelukast should be used with caution in acute exacerbation of asthma, patients with known aspirin sensitivity, when systemic corticosteroid reduction is considered, and in pregnancy or lactation. SIDE EFFECTS: Adverse experiences occurring in 1% of patients with an incidence greater than that in patients treated with placebo, regardless of causalty assessment; abdominal pain, headache, also diarrhea, upper respiratory tract infection, dizziness and asthenia. With prolonged treatment, the adverse experience profile did not significantly change. USE IN PREGNANCY AND LACTATION: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Montelukast should be used during pregnancy only if clearly needed. It is not known if Montelukast is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Montelukast is given to a nursing mother.