2 DOSAGE AND ADMINISTRATION Administration (by indications): Asthma (2.1) : Once daily in the evening for patients 12 months and older. Seasonal allergic rhinitis (2.3) : Once daily for patients 2 years and older. Perennial allergic rhinitis (2.3) : Once daily for patients 6 months and older. Dosage (by age) ( 2 ): 2 to 5 years: 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 (2.4) . For oral granules: Must administer within 15 minutes after opening the packet (with or without mixing with food) (2.5) . 2.1 Asthma Montelukast sodium should be taken once daily in the evening. The following doses are recommended: For pediatric patients 2 to 5 years of age: one packet of 4 mg oral granules . For pediatric patients 12 to 23 months of age: one packet of 4 mg oral granules. Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established. There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The pharmacokinetics of montelukast are similar whether dosed in the morning or evening. Efficacy has been demonstrated for asthma when montelukast was administered in the evening without regard to time of food ingestion. 2.3 Allergic Rhinitis For allergic rhinitis, montelukast sodium should be taken once daily. Efficacy was demonstrated for seasonal allergic rhinitis when montelukast was administered in the morning or the evening without regard to time of food ingestion. The time of administration may be individualized to suit patient needs. The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended: For pediatric patients 2 to 5 years of age: one packet of 4 mg oral granules. Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established. The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended: For pediatric patients 2 to 5 years of age: one packet of 4 mg oral granules. For pediatric patients 6 to 23 months of age: one packet of 4 mg oral granules. Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established. 2.4 Asthma and Allergic Rhinitis Patients with both asthma and allergic rhinitis should take only one montelukast sodium dose daily in the evening. 2.5 Instructions for Administration of Oral Granules Montelukast sodium 4 mg (montelukast) 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, montelukast sodium oral granules must not be stored for future use. Discard any unused portion. Montelukast sodium 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. Montelukast sodium oral granules can be administered without regard to the time of meals.