Montelukast Dosing by Age Group
Montelukast dosing is strictly age-based: 4 mg oral granules or chewable tablet once daily for children 6 months to 5 years, 5 mg chewable tablet once daily for children 6 to 14 years, and 10 mg film-coated tablet once daily for patients 15 years and older. 1
Age-Specific Dosing Recommendations
Infants and Young Children (6 months to 23 months)
- 4 mg oral granules once daily for infants 6 to 23 months of age 2, 1
- The oral granule formulation is bioequivalent to the 4 mg chewable tablet and can be used interchangeably 1
- Systemic exposure in infants 6-11 months is 60% higher (mean AUC) and 89% higher (mean Cmax) compared to adults, though this does not require dose adjustment 1
Preschool Children (2 to 5 years)
- 4 mg chewable tablet once daily 3, 1
- This dose achieves comparable systemic exposure to the adult 10 mg dose 1, 4
- The 4 mg oral granules can be used as an alternative formulation in this age group 1
School-Age Children (6 to 14 years)
- 5 mg chewable tablet once daily 3, 1
- The 5 mg dose was selected based on pharmacokinetic studies demonstrating similar area under the plasma concentration-time curve to the adult 10 mg dose 4
- Clinical trials demonstrated significant improvements in FEV1, symptoms, and quality of life at this dose 5, 6
Adolescents and Adults (≥15 years)
- 10 mg film-coated tablet once daily 1, 4
- This dose was selected as the lowest dose producing maximal improvement in airway function and patient-reported outcomes 4
Administration Guidelines
Timing and Food
- Administer in the evening or at bedtime for optimal effect 7
- Can be taken without regard to meals, though administration with food may improve gastrointestinal tolerability 8, 7
Special Populations
- No dose adjustment required for patients with mild-to-moderate hepatic insufficiency or renal insufficiency 1
- Plasma half-life ranges from 2.7 to 5.5 hours in adults, with minimal drug accumulation during once-daily dosing 1
Critical Safety Considerations
FDA Black Box Warning
- The FDA issued a black box warning regarding serious neuropsychiatric events, including suicidal thoughts and actions, depression, anxiety, sleep disturbances, and behavioral changes 2, 7
- Parents must be explicitly counseled about neuropsychiatric risks before prescribing to any child, and safer alternatives should be considered first 2
- Monitor for unusual behavioral or mood changes, particularly in the first weeks of therapy 2, 7
Common Adverse Events in Infants
- In infants 6-23 months, adverse events (≥2% frequency, more than placebo) include upper respiratory infection, wheezing, otitis media, pharyngitis, tonsillitis, cough, and rhinitis 2
- Overall, the frequency of adverse events in montelukast-treated children of all ages is comparable to placebo 9, 5, 6
Clinical Positioning
Role in Asthma Management
- Montelukast is an alternative therapy for mild persistent asthma when inhaled corticosteroids cannot be used or compliance is problematic 3, 2
- For moderate persistent asthma, combining montelukast with inhaled corticosteroids is an alternative to long-acting beta agonists, though less preferred 3
- Never use for acute asthma exacerbations or rescue therapy; ensure patients have a short-acting beta-agonist available 2
Advantages
- Once-daily oral administration offers superior compliance compared to inhaled therapies 2, 5, 6
- Onset of action within one hour, with improvements in lung function typically observed within 1 day 5, 6, 10
- Approved for both asthma and allergic rhinitis, offering dual benefit for patients with both conditions 2