Montelukast Dosing Recommendations
Montelukast should be administered once daily in the evening or at bedtime, with age-specific dosing: 10 mg for patients ≥15 years, 5 mg for children 6-14 years, and 4 mg for children 2-5 years or 12-23 months. 1
Age-Specific Dosing Schedule
Adults and Adolescents (≥15 years)
- 10 mg film-coated tablet once daily in the evening for asthma or allergic rhinitis 1
- For exercise-induced bronchoconstriction: 10 mg at least 2 hours before exercise, but not more than once in 24 hours 1
- Do not take an additional dose if already taking daily montelukast for chronic asthma 1
Children 6-14 Years
- 5 mg chewable tablet once daily in the evening 1
- This dose was selected to provide systemic exposure comparable to the adult 10 mg dose 2
- Clinical trials demonstrated significant improvements in FEV₁, symptoms, and quality of life at this dose 3
Children 2-5 Years
- 4 mg chewable tablet once daily in the evening 1
- Alternative: 4 mg oral granules for those unable to take chewable tablets 1
- Large multicenter trials in 689 patients demonstrated efficacy and safety at this dose 4
Infants 12-23 Months
- 4 mg oral granules once daily for asthma treatment 1
- Note: Systemic exposure is 33% higher in this age group compared to adults, but safety profile remains acceptable 1
Infants 6-11 Months
- 4 mg oral granules once daily for perennial allergic rhinitis only (not FDA-approved for asthma in this age group) 1
- Caution: Systemic exposure is 60% higher (AUC) and 89% higher (Cmax) than adults 1
Administration Guidelines
Timing and Food Considerations
- Evening or bedtime administration is recommended based on clinical trial evidence showing optimal control of nocturnal symptoms 5, 6
- Can be taken with or without food, though administration with food may improve gastrointestinal tolerability 5, 6
- The American Academy of Allergy, Asthma, and Immunology supports evening dosing based on pivotal trials 5
Oral Granules Administration (4 mg)
- May be given directly in the mouth 1
- Can be dissolved in 1 teaspoon (5 mL) of cold or room temperature baby formula or breast milk 1
- Can be mixed with cold or room temperature soft foods: applesauce, mashed carrots, rice, or ice cream 1
- Must be administered within 15 minutes of preparation; discard any unused portion 1
- Do not mix with liquids other than formula or breast milk 1
Special Population Considerations
Hepatic Impairment
- Mild-to-moderate hepatic insufficiency: 41% higher AUC with mean half-life of 7.4 hours (vs. 2.7-5.5 hours in healthy adults) 1
- No dose adjustment required for mild-to-moderate hepatic impairment 1
- Severe hepatic impairment has not been studied 1
Renal Impairment
- No dose adjustment required as montelukast and metabolites are excreted almost exclusively via bile, not urine 1
Drug Interactions
- No dose adjustment needed when co-administered with theophylline, warfarin, digoxin, oral contraceptives, or prednisone 1
- Phenobarbital decreases montelukast AUC by 40%, but no dose adjustment is recommended 1
Critical Safety Warnings
FDA Black Box Warning
- Monitor for serious neuropsychiatric events including suicidal thoughts, depression, agitation, aggressive behavior, and mood changes 5, 6
- These events can occur at any age and should prompt immediate evaluation 5, 6
Important Clinical Caveats
- Never use montelukast as rescue medication for acute asthma symptoms due to delayed onset of action 7
- Montelukast is less effective than inhaled corticosteroids for most asthma control outcomes 7
- For mild persistent asthma, inhaled corticosteroids remain the preferred first-line therapy 8, 7
- Continue to avoid aspirin/NSAIDs if asthma is aspirin-sensitive 1
Clinical Context from Guidelines
Role in Asthma Management
- For children 2-5 years: Inhaled corticosteroids are preferred; montelukast is an alternative for those unable or unwilling to use inhaled therapy 8
- For children 6-11 years: Similar hierarchy with ICS preferred 8
- Montelukast offers advantages in compliance due to once-daily oral administration 7, 3
- When added to medium-dose ICS, may provide additional benefit before escalating to high-dose ICS 8