What is the recommended dose of montelukast (Singulair) for a pediatric patient?

Montelukast Pediatric Dosing

The recommended dose of montelukast in pediatric patients is age-based: 4 mg oral granules once daily for infants 6-23 months, 4 mg chewable tablet once daily for children 2-5 years, 5 mg chewable tablet once daily for children 6-14 years, and 10 mg tablet once daily for adolescents ≥15 years, all administered in the evening. 1

Age-Specific Dosing Recommendations

Infants (6-23 months)

• 4 mg oral granules once daily 1
• Granules can be administered directly in the mouth, dissolved in 1 teaspoon of cold or room temperature baby formula or breast milk, or mixed with soft foods (applesauce, carrots, rice, or ice cream only) 1
• After opening the packet, the full dose must be administered within 15 minutes and cannot be stored for future use 1
• FDA-approved down to 6 months of age for both asthma and perennial allergic rhinitis 2

Preschool Children (2-5 years)

• 4 mg chewable tablet once daily 1, 2
• Alternative formulation: 4 mg oral granules 1
• Approved for asthma and seasonal allergic rhinitis in this age group 1

School-Age Children (6-14 years)

• 5 mg chewable tablet once daily 1, 2, 3
• This dose was selected based on pharmacokinetic studies demonstrating comparable systemic exposure (AUC) to the adult 10 mg dose 4, 5

Adolescents (≥15 years)

• 10 mg film-coated tablet once daily 1
• Same dosing as adults 1

Timing of Administration

• All doses should be taken once daily in the evening for chronic asthma management 1, 2
• For exercise-induced bronchoconstriction prevention (≥15 years only), take at least 2 hours before exercise 1
• Do not take an additional dose within 24 hours of a previous dose 1
• For allergic rhinitis alone, timing may be individualized, though evening dosing is standard 1

Critical Safety Warnings

Before prescribing montelukast to any child, parents must be explicitly counseled about the FDA black box warning regarding serious neuropsychiatric events. 2

Neuropsychiatric Risks

• FDA issued a black box warning for suicidal thoughts and actions, depression, anxiety, sleep disturbances, and behavioral changes 2
• Monitor for unusual behavioral or mood changes, particularly in the first weeks of therapy 2
• Discuss safer alternatives (inhaled corticosteroids) before initiating montelukast 2

Common Adverse Events in Infants (6-23 months)

• Upper respiratory infection, wheezing, otitis media, pharyngitis, tonsillitis, cough, and rhinitis (≥2% frequency, more than placebo) 2

Clinical Positioning

When to Use Montelukast

• Alternative therapy for mild persistent asthma when inhaled corticosteroids cannot be used or compliance is problematic 2
• Dual benefit for patients with both asthma and allergic rhinitis 2
• Once-daily oral administration offers superior compliance compared to inhaled therapies 2

When NOT to Use Montelukast

• Do not use for acute asthma exacerbations or rescue therapy 2
• Should not be used as monotherapy for moderate-to-severe persistent asthma 6
• Patients already taking montelukast for chronic asthma should not take an additional dose for exercise-induced bronchoconstriction 1

Comparative Efficacy Considerations

• Inhaled corticosteroids (fluticasone) are superior to montelukast for asthma control days and all control outcomes in children with mild-to-moderate persistent asthma 6
• The number needed to treat (NNT) is approximately 6.5, meaning 7 children would need to be treated with inhaled corticosteroids instead of montelukast to achieve one additional treatment response 6
• Montelukast is less efficacious and less cost-effective than long-acting beta agonists as add-on therapy to inhaled corticosteroids for moderate-to-severe persistent asthma 7

Important Clinical Caveats

• Always ensure patients have a short-acting β-agonist available for rescue 2
• Safety and effectiveness in pediatric patients <6 months of age have not been established 1
• Patients with both asthma and allergic rhinitis should take only one tablet daily, not separate doses for each condition 1
• Can be administered without regard to food, though taking with meals may improve gastrointestinal tolerability 8