From the Guidelines
Montelukast 10mg is not recommended for children, as the appropriate dose varies by age, with 5mg being suitable for children 6-14 years old, and 4mg for children 2-5 years old, according to the most recent guidelines 1.
Key Considerations
- The medication is a leukotriene receptor antagonist used to treat asthma and allergic rhinitis by blocking inflammatory mediators that cause airway constriction and mucus production.
- Common side effects include headache, abdominal pain, and in rare cases, neuropsychiatric effects such as agitation, depression, or sleep disturbances.
- Parents should administer the medication in the evening, with or without food, and maintain consistent timing.
- If a dose is missed, they should give the next dose at the regular time without doubling up.
Dosage and Administration
- For children 6-14 years old, the recommended dose is 5mg once daily in the evening.
- For children 2-5 years old, the recommended dose is 4mg once daily in the evening.
- The 10mg dose is only appropriate for adolescents 15 years and older and adults.
Monitoring and Follow-up
- It's essential to continue the medication even when symptoms improve and to consult a healthcare provider before discontinuing, as sudden stoppage may worsen asthma symptoms.
- Parents should also monitor for any behavioral changes and report them promptly to their child's doctor, as noted in previous studies 1.
From the FDA Drug Label
For asthma -Take once daily in the evening: ... One packet of 4-mg oral granules for children 12 to 23 months of age The dosage for pediatric patients 6 to 23 months of age is one packet of 4-mg oral granules. SINGULAIR 4-mg oral granules can be administered either directly in the mouth, dissolved in 1 teaspoonful (5 mL) of cold or room temperature baby formula or breast milk, or mixed with a spoonful of cold or room temperature soft foods; The recommended dose of Montelukast for children is:
- 4-mg oral granules for children 12 to 23 months of age
- The 4-mg oral granules can be given directly in the mouth or mixed with food/baby formula There is no information about a 1OMG (10mg) dose for children in the provided drug labels 2 2.
From the Research
Montelukast in Children
- Montelukast is a cysteinyl leukotriene receptor antagonist used as a preventive treatment for persistent asthma in patients ≥2 years of age 3, 4.
- In children aged 6 to 14 years, montelukast (5 mg/day) treatment resulted in a significant increase in FEV1 and improvements in symptoms, exacerbation rates, beta-agonist usage, and quality of life 3, 4.
- For children aged 2 to 5 years, a 4 mg/day dose of montelukast was selected based on population pharmacokinetics, yielding a single-dose pharmacokinetic profile comparable to that of the 10 mg film-coated tablet dose in adults 5.
Dosage and Administration
- The dose of montelukast for 6- to 14-year-old children was selected as 5 mg/day, based on a chewable tablet dose yielding a single-dose area under the plasma concentration-time curve (AUC) comparable to that achieved with the adult 10 mg film-coated tablet dose 6.
- For children ages 2 to 5 years, the 4 mg once-daily chewable tablet dose of montelukast was well tolerated and yielded an AUCpop similar to that of the adult AUCpop observed after a 10 mg film-coated tablet dose 5.
Efficacy and Safety
- Montelukast has shown efficacy as a preventive treatment for asthma during clinical trials in children aged 2 to 14 years, offering benefits over more standard therapies in terms of compliance and convenience 3, 4.
- The drug is generally well tolerated, with the frequency of adverse events in montelukast-treated children comparable to that in patients receiving placebo 3, 4.
- Montelukast is also effective and well-tolerated in the treatment of allergic rhinitis, with leukotrienes playing an important role in the diseases of asthma and allergic rhinitis 7.