Indications
The prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older.
The relief of symptoms of seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older, and perennial allergic rhinitis in adults and pediatric patients 6 months of age and older.
Contraindications
Known hypersensitivity to any of the active substance or excipients.
Compositon/Ingredients
Montelukast 4 mg
Dosage and administration
Smart-Air 4mg should be taken once daily.
Asthma or allergic rhinitis: Adult and adolescents ≥ 15 years of age: 10 mg. Pediatric patients 6 to 14 years of age: 5 mg, 2 to 5 years old: 4 mg.
Pediatric patients 12 to 23 months of age with asthma, 6 to 23 months of age with perennial allergic rhinitis: 4 mg (packet of oral granules).
Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis and in patients less than 12 months of age with asthma have not established.
Precaution
Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks.
Should not be: abruptly substituted for inhaled or oral corticosteroids; used as monotherapy for the treatment and management of exercise-induced bronchospasm.
Patients with known aspirin sensitivity: continue avoidance of aspirin/NSAIDs while taking montelukast.
Montelukast should be used during pregnancy only if clearly essential. Caution should be exercised when montelukast is given to a nursing mother.
Caution should be exercised when patients drive or operate machinery.
Patients with phenylketonuria (PKU).
Storage
Store at temperature below 30°C, protect from light.
