Can Montek LC (montelukast) be given to patients under 18 years?

Can Montek LC (Montelukast) Be Given Below 18 Years?

Yes, montelukast can be safely given to patients under 18 years of age, with specific age-appropriate dosing formulations available for children as young as 6 months for certain indications.

Age-Specific Dosing and Formulations

Montelukast is approved and well-established for pediatric use across multiple age groups with distinct formulations 1:

Infants and Toddlers (6-23 months)

• 4-mg oral granules are approved for perennial allergic rhinitis in patients 6-23 months of age 1
• For asthma treatment, 4-mg oral granules are approved for children 12-23 months of age 1
• Safety has been demonstrated in 172 pediatric patients in this age range, with 124 receiving montelukast in controlled trials 1

Young Children (2-5 years)

• 4-mg chewable tablet once daily is the appropriate dose 2, 1
• This formulation has demonstrated safety and efficacy in adequate and well-controlled studies 1
• The dose selection was based on pharmacokinetic matching to achieve similar systemic exposure as the adult 10-mg dose 3

School-Age Children (6-14 years)

• 5-mg chewable tablet once daily is recommended 2, 1
• This dose provides comparable systemic exposure (AUC) to the adult 10-mg film-coated tablet 4, 5
• Safety and efficacy profiles in this age group are similar to those seen in adults 1

Adolescents (≥15 years)

• 10-mg film-coated tablet once daily, same as adult dosing 1
• The plasma concentration profile is similar between adolescents ≥15 years and young adults 1

Clinical Evidence Supporting Pediatric Use

Montelukast is recognized as an alternative therapy for mild persistent asthma in children, though inhaled corticosteroids remain the preferred first-line treatment 2:

• Leukotriene receptor antagonists (LTRAs) including montelukast are alternative, but not preferred, therapy for step 2 care (mild persistent asthma) 2
• LTRAs can be used as adjunctive therapy with inhaled corticosteroids, though for youths 12 years and older, they are not the preferred adjunctive therapy compared to long-acting beta agonists 2
• Clinical trials in 6-14 year-olds demonstrated significant improvements in FEV₁, symptom scores, exacerbation rates, and beta-agonist usage 6

Safety Profile in Pediatric Populations

The tolerability of montelukast in children mirrors that of adults 7:

• The overall incidence of adverse events in montelukast-treated children was comparable to placebo 7
• No age-specific contraindications exist for children 12 years and older 2
• Long-term safety has been established with children receiving treatment for up to 1.8 years in clinical trials 7

Critical Safety Warning

The FDA has issued a black box warning regarding serious neuropsychiatric events including suicidal thoughts or actions 8:

• Monitor all patients, including children and adolescents, for unusual behavioral or mood changes when starting montelukast 8
• This warning applies across all age groups receiving the medication

Common Pitfalls to Avoid

• Do not use adult formulations in young children: Each age group requires its specific formulation (granules, 4-mg chewable, 5-mg chewable, or 10-mg tablet) to ensure appropriate dosing 1
• Do not use montelukast as first-line monotherapy: Inhaled corticosteroids are more effective for persistent asthma control in both children and adults 2
• Do not overlook the neuropsychiatric warning: This is particularly important in adolescents who may be at higher risk for mood disorders 8
• Do not assume efficacy below 6 months for perennial allergic rhinitis or below 12 months for asthma: Safety and effectiveness have not been established in these younger age groups 1