Montelukastdosage

Administration (by indications): Asthma: Once daily in the evening for patients 12 months and older.

Acute prevention of EIB: One tablet at least 2 hours before exercise for patients 6 years of age and older.

Seasonal allergic rhinitis: Once daily for patients 2 years and older.

Perennial allergic rhinitis: Once daily for patients 6 months and older. Dosage (by age): 15 years and older: one 10-mg tablet. 6 to 14 years: one 5-mg chewable tablet. 2 to 5 years: one 4-mg chewable tablet or one packet of 4-mg oral granules. 6 to 23 months: one packet of 4-mg oral granules. Patients with both asthma and allergic rhinitis should take only one dose daily in the evening.

For oral granules: Must administer within 15 minutes after opening the packet (with or without mixing with food). 2.1 Asthma For asthma, administer SINGULAIR orally once daily in the evening, with or without food. There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The following doses are recommended: Table 1: Recommended Dosage in Asthma Age Dose Adult and adolescent patients 15 years of age and older one 10 mg tablet Pediatric patients 6 to 14 years of age one 5 mg chewable tablet Pediatric patients 2 to 5 years of age one 4 mg chewable tablet or one packet of oral granules Pediatric patients 12 to 23 months of age Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established. one packet 4 mg oral granules Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.

2.2 Exercise-Induced

Bronchoconstriction (EIB) For prevention of EIB, administer a single dose of SINGULAIR orally at least 2 hours, before exercise. The following doses are recommended: Table 2: Recommended Dosage in Exercise-Induced Bronchoconstriction (EIB) Age Dose Adult and adolescent patients 15 years of age and older one 10 mg tablet Pediatric patients 6 to 14 years of age Safety and effectiveness in patients younger than 6 years of age have not been established. one 5 mg chewable tablet An additional dose of SINGULAIR should not be taken within 24 hours of a previous dose. Patients already taking SINGULAIR daily for another indication (including chronic asthma) should not take an additional dose to prevent EIB. All patients should have available for rescue a short-acting β-agonist. Daily administration of SINGULAIR for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.

2.3 Allergic

Rhinitis For allergic rhinitis, administer SINGULAIR orally once daily without regard to time of food ingestion. Time of administration in patients with allergic rhinitis can be individualized to suit patient needs. The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended: Table 3: Recommended Dosage in Seasonal Allergic Rhinitis Age Dose Adult and adolescent patients 15 years of age and older one 10 mg tablet Pediatric patients 6 to 14 years of age one 5 mg chewable tablet Pediatric patients 2 to 5 years of age Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established. one 4 mg chewable tablet or one packet of 4 mg oral granules The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended: Table 4: Recommended Dosage in Perennial Allergic Rhinitis Age Dose Adult and adolescent patients 15 years of age and older one 10 mg tablet Pediatric patients 6 to 14 years of age one 5 mg chewable tablet Pediatric patients 2 to 5 years of age one 4 mg chewable tablet or one packet of 4 mg oral granules Pediatric patients 6 to 23 months of age Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established. one packet of 4 mg oral granules Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.

2.4 Asthma and

Allergic Rhinitis For patients with both asthma and allergic rhinitis, administer only one SINGULAIR dose orally once daily in the evening. Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.

2.5 Instructions for

Administration of Oral Granules SINGULAIR 4-mg oral granules can be administered either directly in the mouth, dissolved in 1 teaspoonful (5 mL) of cold or room temperature baby formula or breast milk, or mixed with a spoonful of cold or room temperature soft foods; based on stability studies, only applesauce, carrots, rice, or ice cream should be used. The packet should not be opened until ready to use. After opening the packet, the full dose (with or without mixing with baby formula, breast milk, or food) must be administered within 15 minutes. If mixed with baby formula, breast milk, or food, SINGULAIR oral granules must not be stored for future use. Discard any unused portion. SINGULAIR oral granules are not intended to be dissolved in any liquid other than baby formula or breast milk for administration. However, liquids may be taken subsequent to administration. SINGULAIR oral granules can be administered without regard to the time of meals.