Drug Detail:Singulair (Montelukast [ mon-te-loo-kast ])
Generic Name: MONTELUKAST SODIUM 4mg
Dosage Form: tablets, chewable tablets, oral granules
Drug Class: Leukotriene modifiers
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:
| 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* | 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.
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:
| 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 |
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.
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:
| 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 |
The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended:
| 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* | 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.
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.
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.
