What is the recommended dose of montelukast (Singulair) for a 10-year-old child?

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Recommended Dose of Montelukast for a 10-Year-Old Child

The recommended dose of montelukast for a 10-year-old child is 5 mg once daily in the evening, administered as a chewable tablet. 1, 2

Dosage Guidelines by Age

  • Ages 6-14 years: 5 mg chewable tablet once daily 1, 2
  • Ages 2-5 years: 4 mg chewable tablet or oral granules once daily 1, 2
  • Ages 15 years and older: 10 mg tablet once daily 2

Administration Recommendations

  • Montelukast should be taken once daily in the evening for asthma management 2
  • The medication can be taken with or without food 2
  • For optimal asthma control, the medication should be taken consistently at approximately the same time each day 2

Clinical Evidence Supporting This Dosage

The 5 mg dose for children 6-14 years was carefully determined through pharmacokinetic studies to provide comparable systemic exposure to the adult 10 mg dose 3. This dosage was selected to achieve an area under the plasma concentration-time curve similar to adults, which is the pharmacokinetic measurement that best represents systemic exposure to the drug 3.

Efficacy of Montelukast at This Dosage

  • In children aged 6-14 years, montelukast (5 mg/day) has demonstrated significant improvements in FEV1 (forced expiratory volume in 1 second) 4, 5
  • Improvements in lung function and reductions in as-needed β2-agonist usage are generally observed within 1 day after initiating therapy 4
  • The medication also shows benefits for symptom control, reduced exacerbation rates, and improved quality of life 4, 5

Safety Profile

  • Montelukast is generally well-tolerated in children, with an adverse event profile similar to placebo 6
  • No dose-related adverse effects have been observed even at doses substantially higher than recommended 6
  • The frequency of adverse events in montelukast-treated children is comparable to that in patients receiving placebo 4, 5

Important Considerations

  • Montelukast should not be used for the immediate relief of an asthma attack; a rescue inhaler should always be available 2
  • For exercise-induced bronchoconstriction prevention, montelukast should be taken at least 2 hours before exercise (applicable to patients 15 years and older) 2
  • Behavior and mood-related changes have been reported with montelukast use and should be monitored 2

Role in Asthma Management

While montelukast is effective for many children with asthma, it's important to note that inhaled corticosteroids (ICS) are generally more effective as first-line therapy for persistent asthma in children 1. Studies have shown that fluticasone propionate monotherapy provides better asthma control days compared to montelukast monotherapy in children with mild-to-moderate persistent asthma 1.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Spotlight on montelukast in asthma in children 2 to 14 years of age.

American journal of respiratory medicine : drugs, devices, and other interventions, 2002

Research

Clinical safety and tolerability of montelukast, a leukotriene receptor antagonist, in controlled clinical trials in patients aged > or = 6 years.

Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 2001

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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