Montelukast Dosing
Montelukast is dosed once daily based on age: 10 mg for adults and adolescents ≥15 years, 5 mg chewable tablet for children 6-14 years, and 4 mg chewable tablet or oral granules for children 2-5 years, with the medication taken in the evening for asthma or at any consistent time for allergic rhinitis. 1
Age-Based Dosing for Asthma
The FDA-approved dosing regimen for asthma is administered once daily in the evening 1:
- Adults and adolescents ≥15 years: 10 mg tablet 1
- Children 6-14 years: 5 mg chewable tablet 1
- Children 2-5 years: 4 mg chewable tablet or one packet of 4 mg oral granules 1
- Children 12-23 months: One packet of 4 mg oral granules 1
The adult 10 mg dose was selected as the lowest dose producing maximal improvement in airway function and patient-reported outcomes 2. The pediatric 5 mg dose was specifically chosen to provide systemic drug exposure comparable to the adult 10 mg dose, based on area under the plasma concentration-time curve matching 2, 3.
Age-Based Dosing for Allergic Rhinitis
For allergic rhinitis, montelukast is taken once daily at approximately the same time each day 1:
- Adults and adolescents ≥15 years: 10 mg tablet 1
- Children 6-14 years: 5 mg chewable tablet 1
- Children 2-5 years: 4 mg chewable tablet or oral granules (seasonal allergic rhinitis) 1
- Children 6 months-5 years: One packet of 4 mg oral granules (perennial allergic rhinitis) 1
Montelukast is approved by the FDA for both seasonal and perennial allergic rhinitis 4, 1.
Exercise-Induced Bronchoconstriction
For prevention of exercise-induced asthma in patients ≥15 years, take one 10 mg tablet at least 2 hours before exercise 1. Critical caveat: If already taking montelukast daily for chronic asthma or allergic rhinitis, do not take an additional dose for exercise—the daily dose provides coverage 1. Do not take more than one dose within 24 hours 1.
Administration Guidelines
- Timing: Evening administration is recommended for asthma based on pharmacodynamic profile 5. For allergic rhinitis alone, take at a consistent time daily 1
- Food: May be taken with or without food 1
- Oral granules: Can be given directly in the mouth, dissolved in 5 mL of cold/room temperature formula or breast milk, or mixed with soft foods (applesauce, mashed carrots, rice, ice cream) 1. Must be administered within 15 minutes of preparation and cannot be stored 1
Clinical Context and Positioning
While montelukast is effective for both conditions, the American College of Allergy, Asthma, and Immunology states it is less effective than intranasal corticosteroids for allergic rhinitis 4, 6. Intranasal corticosteroids should be recommended over montelukast for initial treatment of seasonal allergic rhinitis 4. However, montelukast is particularly valuable for patients with both asthma and allergic rhinitis, as it addresses both conditions simultaneously 4, 6.
Onset of Action and Monitoring
Montelukast begins producing clinical benefits by the second day of daily treatment 5, which is slower than antihistamines 6. The medication provides continuous control rather than acute symptom relief 5. Important safety consideration: The FDA black box warning requires monitoring for neuropsychiatric events including mood changes, agitation, depression, suicidal thoughts, and behavioral changes 5, 1.