Singulair Dosage for an 11-Year-Old Male
For an 11-year-old male, the recommended dose of Singulair (montelukast) is 5 mg once daily, administered as a chewable tablet in the evening. 1
Age-Appropriate Dosing
- The FDA-approved dosing for montelukast in pediatric patients aged 6 to 14 years is 5 mg once daily, given as a chewable tablet 1
- This 5 mg dose was specifically selected to provide systemic drug exposure (area under the plasma concentration curve) comparable to the adult 10 mg dose, ensuring similar therapeutic efficacy 2, 3
- The 5 mg chewable tablet should be administered once daily in the evening, based on the drug's pharmacodynamic profile 4
Administration Guidelines
- Montelukast can be taken without regard to meals, though administration with food may improve gastrointestinal tolerability if needed 4
- The chewable tablet formulation is designed for ease of administration in this age group 5
- No dose adjustment is required based on body weight for children in the 6-14 year age range 1
Pharmacokinetic Rationale
- The plasma half-life of montelukast ranges from 2.7 to 5.5 hours in healthy young adults, with minimal drug accumulation (14%) during once-daily dosing 1
- Pharmacokinetic studies demonstrated that the 5 mg chewable tablet in children aged 6-14 years produces mean systemic exposure similar to the 10 mg film-coated tablet in adults 1
- This dose-selection strategy was validated in clinical efficacy trials showing significant improvements in FEV₁, symptom scores, and β-agonist use 1, 5
Clinical Efficacy Evidence
- In an 8-week randomized, double-blind trial of 336 pediatric patients aged 6-14 years, the 5 mg daily dose resulted in significant improvement in mean morning FEV₁ (8.7% change from baseline vs 4.2% with placebo, p<0.001) 1
- Treatment significantly decreased "as-needed" β-agonist use by 11.7% from baseline compared to an 8.2% increase with placebo (p<0.05) 1
- The percentage of days with asthma exacerbations was significantly reduced (20.6% with montelukast vs 25.7% with placebo, p≤0.05) 1
- Clinical benefit is typically evident within 1 day of initiating therapy 5, 6
Important Safety Considerations
- The FDA has issued a black box warning for montelukast regarding potential neuropsychiatric events; patients should be monitored for mood changes, behavioral changes, suicidal thoughts, or other unusual symptoms 7
- Montelukast is generally well tolerated in children, with adverse event frequency comparable to placebo 5, 6
- No routine laboratory monitoring is required 8
- No dose adjustment is needed for renal insufficiency, as montelukast and its metabolites are excreted almost exclusively via bile 1
Common Clinical Pitfalls
- Never use montelukast as monotherapy for acute asthma exacerbations—it is a controller medication for chronic asthma management, not a rescue medication 1
- Ensure the patient receives the age-appropriate formulation (5 mg chewable tablet, not the 10 mg film-coated tablet intended for patients ≥15 years) 1
- Do not discontinue inhaled corticosteroids abruptly when adding montelukast; it is intended as add-on therapy or alternative controller medication, not a replacement for inhaled corticosteroids in moderate-to-severe asthma 1